AU2023208213B2

AU2023208213B2 - Prosthetic heart valve

Info

Publication number: AU2023208213B2
Application number: AU2023208213A
Authority: AU
Inventors: Netanel Benichou; Larisa Dadonkin; Bella Felsen; Nik Gurovich; Tamir Levi; David Maimon; Son V. Nguyen; Ziv Yohanan
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2010-10-05
Filing date: 2023-07-28
Publication date: 2025-07-10
Anticipated expiration: 2031-10-05
Also published as: AU2017228618A1; AU2019272011A1; AU2015268755A1; AU2019272013B2; AU2025208527A1; AU2019272011B2; AU2023208213A1; AU2019272012B2; AU2022204582A1; AU2022204586A1; AU2019272005B2; AU2020233732B2; AU2020200377B2; AU2020200377A1; AU2020233732A1; AU2015268755B2; AU2019272013A1; AU2023208189A1; AU2019222929B2; AU2019222929A1

Abstract

#$%^&*AU2023208213B220250710.pdf##### PROSTHETIC HEART VALVE ABSTRACT An implantable prosthetic heart valve (10; 310; 600) that is collapsible to a collapsed configuration and expandable to an expanded configuration, the valve (10; 310; 600) comprising: a balloon-expandable annular frame (12; 50; 312) having an inflow end portion (174; 508; 610) and an outflow end portion (506; 612), and a leaflet structure (14; 204; 314) positioned within the frame (12; 50; 312), wherein the frame (12; 50; 312) comprises: an inflow row of openings (36) at the inflow end portion (174; 508; 610), an outflow row of openings (40) at the outflow end portion (506; 612), and at least one intermediate row of openings (38) between the inflow row of openings (36) and the outflow row of openings (40), wherein the openings (40) of the outflow row are larger than the openings (36) of the inflow row and the openings (38) of the at least one intermediate row; and wherein the outflow row of openings (40) is formed by a first row of angled struts (32) and a second row of angled struts (28), connected to one another by a plurality of axially extending commissure frame portions (30) and a plurality of axially extending struts (31), said each of the plurality of axially commissure frame portions (30) configured to mount a respective commissure of the leaflet structure (14; 204; 314); wherein each one of the plurality of axially extending commissure frame portions (30) and each one of the plurality of axially extending struts (31) extends from a first location defined by a convergence of two lower ends of two angled struts (32) of the first row of angled struts (32) to a second location defined by the convergence of two upper ends of two angled struts (28) of the second row of angled struts (28). PROSTHETIC HEART VALVE 2023208213 28 Jul 2023 ABSTRACT An implantable prosthetic heart valve (10; 310; 600) that is collapsible to a collapsed configuration and expandable to an expanded configuration, the valve (10; 310; 600) comprising: a balloon-expandable annular frame (12; 50; 312) having an inflow end portion (174; 508; 610) and an outflow end portion (506; 612), and a leaflet structure (14; 204; 314) positioned within the frame (12; 50; 312), wherein the frame (12; 50; 312) comprises: an inflow row of openings (36) at the inflow end portion (174; 508; 610), an outflow row of openings (40) at the outflow end portion (506; 612), and at least one intermediate row of openings (38) between the inflow row of openings (36) and the outflow row of openings (40), wherein the openings (40) of the outflow row are larger than the openings (36) of the inflow row and the openings (38) of the at least one intermediate row; and wherein the outflow row of openings (40) is formed by a first row of angled struts (32) and a second row of angled struts (28), connected to one another by a plurality of axially extending commissure frame portions (30) and a plurality of axially extending struts (31), said each of the plurality of axially commissure frame portions (30) configured to mount a respective commissure of the leaflet structure (14; 204; 314); wherein each one of the plurality of axially extending commissure frame portions (30) and each one of the plurality of axially extending struts (31) extends from a first location defined by a convergence of two lower ends of two angled struts (32) of the first row of angled struts (32) to a second location defined by the convergence of two upper ends of two angled struts (28) of the second row of angled struts (28). AH25(42477228_1):BJM

Description

2023208213 28 Jul 2023

PROSTHETIC HEART PROSTHETIC HEART VALVE VALVE CROSS-REFERENCE TOTORELATED CROSS-REFERENCE RELATEDAPPLICATION APPLICATION

[0001] This

[0001] This is is aa divisional divisionalapplication applicationof ofAustralian AustralianPatent PatentApplication ApplicationNo. No.2022204586, filed 2022204586, filed

on 28 on 28 June June 2022. 2022. The Theentire entiredisclosure disclosureofofAustralian Australian Patent Patent Application ApplicationNo. No.2022204586 2022204586is is hereby incorporated by reference in its entirety and for all purposes. hereby incorporated by reference in its entirety and for all purposes.

FIELD FIELD

[0002] The

[0002] Thepresent present disclosure disclosure concerns concerns embodiments embodiments ofprosthetic of a a prostheticheart heartvalve, valve,and anddelivery delivery systems for implanting heart valves. systems for implanting heart valves.

BACKGROUND BACKGROUND

[0003] human Thehuman

[0003] The heartcancansuffer heart fromvarious sufferfrom valvulardiseases. variousvalvular These diseases.These valvular valvular diseasescancan diseases

result in significant malfunctioning of the heart and ultimately require replacement of the native result in significant malfunctioning of the heart and ultimately require replacement of the native

valve with valve with an an artificial artificial valve. valve.There Thereare area anumber number of of known artificial valves known artificial valvesand and aanumber of number of

knownmethods known methods of of implanting implanting these these artificial valves artificial valves inin humans. humans.

[0004] Various

[0004] Varioussurgical surgical techniques techniques may maybebeused usedtotoreplace replaceororrepair repair aa diseased diseased or or damaged damaged valve. Due valve. Duetotostenosis stenosis and andother otherheart heart valve valve diseases, diseases, thousands thousands of of patients patients undergo surgery undergo surgery

each year wherein the defective native heart valve is replaced by a prosthetic valve. Another each year wherein the defective native heart valve is replaced by a prosthetic valve. Another

less drastic method for treating defective valves is through repair or reconstruction, which is less drastic method for treating defective valves is through repair or reconstruction, which is

typically used typically used on on minimally calcified valves. minimally calcified The problem valves. The problemwith withsurgical surgicaltherapy therapyisis the the significant riskitit imposes significant risk imposeson on these these chronically chronically ill patients ill patients with with high morbidity high morbidity and mortality and mortality

rates associated with surgical repair. rates associated with surgical repair.

[0005] When the native valve is replaced, surgical implantation of the prosthetic valve typically

requires an requires an open-chest surgery during open-chest surgery during which whichthe theheart heart is is stopped and patient stopped and patient placed on placed on

cardiopulmonarybypass cardiopulmonary bypass (a (a so-called"heart-lung so-called "heart-lungmachine"). machine").In In oneone common common surgical surgical

procedure, the diseased native valve leaflets are excised and a prosthetic valve is sutured to the procedure, the diseased native valve leaflets are excised and a prosthetic valve is sutured to the

surrounding tissue surrounding tissue at at the the valve valve annulus. annulus. Because ofthe Because of the trauma traumaassociated associated with withthe the procedure procedure and the attendant duration of extracorporeal blood circulation, some patients do not survive the and the attendant duration of extracorporeal blood circulation, some patients do not survive the

surgical procedure surgical procedure or or diedie shortly shortly thereafter. thereafter. It isItwell is well knownknown that thethat riskthe to risk to the patient the patient increases increases

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with the amount of time required on extracorporeal circulation. Due to these risks, a substantial with the amount of time required on extracorporeal circulation. Due to these risks, a substantial

numberofofpatients number patients with with defective defective native native valves valves are are deemed inoperablebecause deemed inoperable becausetheir theircondition conditionisis too frail too frailtotowithstand withstandthe theprocedure. procedure. By By some estimates, more some estimates, morethan than50% 50%ofof thesubjects the subjects suffering suffering from valve stenosis from valve stenosis who are older who are older than than 80 years cannot 80 years be operated cannot be operated on onfor for valve valve replacement. replacement. 2023208213

[0006] Becauseofofthe

[0006] Because thedrawbacks drawbacks associatedwith associated withconventional conventional open-heart open-heart surgery, surgery, percutaneous percutaneous

and minimally-invasivesurgical and minimally-invasive surgicalapproaches approachesare aregarnering garneringintense intenseattention. attention. InInone onetechnique, technique,aa prosthetic valve prosthetic valve is isconfigured configured to tobe beimplanted implanted in inaamuch much less less invasive invasive procedure procedure by wayofof by way

catheterization. catheterization. For For instance, instance, U.S. U.S. Patent PatentNos. Nos. 5,411,522 5,411,522 and 6,730,118, which and 6,730,118, whichare areincorporated incorporated herein by reference, describe collapsible transcatheter heart valves that can be percutaneously herein by reference, describe collapsible transcatheter heart valves that can be percutaneously

introduced in aa compressed introduced in state on compressed state on aa catheter catheter and and expanded inthe expanded in the desired desired position position by by balloon balloon

inflation or by inflation or byutilization utilizationofofa aself-expanding self-expanding frame frame or stent. or stent.

[0007]

[0007] AnAn important important design design parameter parameter of a transcatheter of a transcatheter heart heart valve valve is the is theofdiameter diameter of the folded the folded

or crimpedprofile. or crimped profile. TheThe diameter diameter of theof the crimped crimped profile profile is is important important because itbecause directly it directly

influences thephysician's influences the physician’s ability ability to advance to advance the transcatheter the transcatheter heartthrough heart valve valve the through the femoral femoral

artery or vein. More particularly, a smaller profile allows for treatment of a wider population of artery or vein. More particularly, a smaller profile allows for treatment of a wider population of

patients, with enhanced safety. patients, with enhanced safety.

SUMMARY OFTHE SUMMARY OF THEINVENTION INVENTION

[0008]

[0008] ItItis is an anobject objectofofthe thepresent present invention invention to substantially to substantially overcome, overcome, or atameliorate, or at least least ameliorate, one ormore one or moreof of thethe disadvantages disadvantages of existing of existing arrangements, arrangements, or provide or at least at leastaprovide useful a useful

alternative to existing arrangements. alternative to existing arrangements.

[0009] Thepresent

[0009] The presentdisclosure disclosure is is directed directed toward toward methods andapparatuses methods and apparatusesrelating relatingto to prosthetic prosthetic valves, such valves, such as as heart heart valves, valves,delivery deliveryapparatuses, apparatuses,and andassemblies assemblies of ofheart heartvalves valvesmounted mounted on on

delivery apparatuses. delivery apparatuses.

[0010]

[0010] InInone one aspect, aspect, thethe invention invention provides provides an implantable an implantable prosthetic prosthetic heart heart valve that valve is that is collapsible collapsible to toaacollapsed collapsedconfiguration configurationand and expandable to an expandable to an expanded configuration,the expanded configuration, the valve comprising: valve comprising:

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aa balloon-expandable annularframe balloon-expandable annular framehaving having anan inflow inflow endend portion portion andand an an outflow outflow endend

portion and portion being formed and being formedfrom froma aplastically-expandable plastically-expandablematerial materialincluding includingone oneorormore more of: of:

stainless stainless steel steeloror a polymer a polymerorora a nickel-cobalt-chromium nickel-cobalt-chromium alloy alloy or or combinations thereof, and combinations thereof, and

a leaflet structure positioned within the frame, a leaflet structure positioned within the frame,

whereinthe wherein the frame framecomprises: comprises: an an inflow rowof inflow row of openings openingsatat the the inflow inflow end end portion, portion, an an outflow rowofofopenings outflow row openingsatat 2023208213

the outflow the end portion, outflow end portion, and at least and at leastone oneintermediate intermediaterow row of of openings openings between the inflow between the inflow row of row of openings openingsand andthe theoutflow outflowrow rowofofopenings, openings,wherein wherein thethe openings openings of of thethe inflow inflow rowrow

of openings are larger than the openings of the at least one intermediate row of openings, of openings are larger than the openings of the at least one intermediate row of openings,

whereinthe wherein the openings openingsofofthe the outflow outflowrow roware arelarger larger than than the the openings openingsof of the the inflow inflow row row and theopenings and the openings of the of the at least at least one one intermediate intermediate row; and row; and

whereinthe wherein the outflow outflowrow rowofofopenings openingsisisformed formedbyby a a first row first rowofof angled angledstruts struts and a and a

second row second row of of angled angled struts, struts, connected connected to one to one another another by a plurality by a plurality ofextending of axially axially extending window frame portions and a plurality of axially extending struts, said each of the window frame portions and a plurality of axially extending struts, said each of the

plurality of plurality ofaxially axiallyextending extendingwindow frameportions window frame portionsconfigured configuredtotomount mounta arespective respective commissure of the commissure of the leaflet leaflet structure; structure;

whereineach wherein eachone oneofofthe the plurality plurality of of axially axiallyextending extending window frameportions window frame portionsand and each oneofofthetheplurality each one plurality of of axially axially extending extending struts struts extends extends from a from first a first location location defined defined

by a convergence of two lower ends of two angled struts of the first row of angled struts to by a convergence of two lower ends of two angled struts of the first row of angled struts to

a second a location defined second location by aa convergence defined by convergence ofoftwo twoupper upperends endsofoftwo two angled angled strutsofofthe struts the second row second row of of angled angled struts. struts.

[0011] In another

[0011] In another aspect, aspect, the the invention invention provides provides an an assembly comprising: assembly comprising:

a delivery a delivery apparatus apparatus comprising anelongated comprising an elongatedshaft; shaft; and and the above-described implantable prosthetic heart valve, said prosthetic heart valve the above-described implantable prosthetic heart valve, said prosthetic heart valve

configured to be implanted in a patient’s body. configured to be implanted in a patient's body.

[0012] Thereisis also

[0012] There also disclosed disclosed herein herein an an assembly for implanting assembly for implanting aa balloon-expandable balloon-expandable prosthetic aortic heart valve in a patient's body, the assembly comprising: prosthetic aortic heart valve in a patient's body, the assembly comprising:

a delivery a delivery apparatus apparatus comprising anelongated comprising an elongatedshaft shaft having havingananinflatable inflatable balloon, balloon, and and

a prosthetic aortic heart valve having a balloon-expandable frame having a radially a prosthetic aortic heart valve having a balloon-expandable frame having a radially

collapsed state and a radially expanded state, the frame comprising: collapsed state and a radially expanded state, the frame comprising:

an an inflow rowof inflow row of openings openingsatat an an inflow inflowend endportion portionof of the the frame, frame, an an outflow rowofofopenings outflow row openingsatatan anoutflow outflowend endportion portionofofthe the frame; frame;and and

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at at least leastone oneintermediate intermediaterow row of of openings openings between the inflow between the inflowrow rowofofopenings openingsand and outflow rowofofopenings; outflow row openings; whereinthe wherein the inflow inflow row rowofofopenings openingsisisformed formedbybya acircumferentially circumferentiallyextending extendinglower lower row row

of angledstruts of angled strutsarranged arranged end-to-end end-to-end and a and a circumferentially circumferentially extendingextending first intermediate first intermediate 2023208213

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rowofofangled row angled struts struts arranged arranged end-to-end, end-to-end, the and the lower lower and first first intermediate intermediate rows struts rows of angled of angled struts interconnected interconnected by by a plurality a plurality of substantially of substantially straight, straight, axially axially extending extending struts, struts,

wherein the wherein the outflow outflowrow rowofofopenings openingsisisformed formedbyby a circumferentiallyextending a circumferentially extendingupper upper row of row of angled angled struts struts arranged end-to-end and arranged end-to-end andaa circumferentially circumferentially extending extending second secondintermediate intermediate row of row of angled angled struts struts arranged end-to-end, the arranged end-to-end, the upper and second upper and secondintermediate intermediaterows rowsofofangled angled struts struts interconnected interconnected by by a plurality a plurality of axially of axially extending extending strutsstruts and a and a plurality plurality of angularly of angularly

spaced, axially spaced, axially extending commissurewindow extending commissure window frame frame portions, portions, wherein wherein each each axially axially extending extending

strut and strut and each each commissure window commissure window frame frame portion portion of the of the outflow outflow rowrow of openings of openings extends extends from from a a location defined location defined by the convergence by the ofthe convergence of the lower lower ends endsofoftwo twoangled angledstruts struts of of the the upper upper row of row of

angled struts angled struts toto another anotherlocation locationdefined definedby bythe theconvergence of the convergence of the upper upper ends of of two angled two angled

struts struts of of the secondintermediate the second intermediate row row of angled of angled struts;struts; and and whereinadjacent wherein adjacent angled angled struts struts offrame of the the frame form anform anglean ofangle of at at least least 120°, 120, when the when the frame frame isisin inthe theradially radiallyexpanded expanded state. state.

is is There

[0013]There

[0013] also also disclosed disclosed herein herein a balloon-expandable prostheticprosthetic a balloon-expandable aortic heart with valve valveheart aortic a with a radially collapsed radially collapsedstate stateandand radially radially expanded expanded state,state, the prosthetic the prosthetic aortic aortic heartcomprising: heart valve valve comprising: a balloon-expandable a framecomprising balloon-expandable frame comprising a materialselected a material selectedfrom from a group a group comprising comprising

stainless stainless steel steeland anda acobalt-chromium alloy, the cobalt-chromium alloy, the frame frame comprising: comprising:

an inflow an inflow row row of ofopenings openingsatat an an inflow inflow end endportion portion of of the the frame; frame; an outflow an outflow row rowofofopenings openingsatatananoutflow outflowend endportion portionofofthe the frame; frame; and and at least at leastone oneintermediate intermediaterow row of of openings openings between the inflow between the inflow row rowofofopenings openingsand and outflow row outflow rowofofopenings; openings; wherein the wherein the inflow inflow row rowofofopenings openingsisisformed formedbybya acircumferentially circumferentiallyextending extendinglower lower rowofofangled row angled struts struts arranged arranged end-to-end end-to-end and a circumferentially and a circumferentially extending extending first intermediate first intermediate

rowofofangled row angled struts struts arranged arranged end-to-end, end-to-end, the and the lower lower and first first intermediate intermediate rows struts rows of angled of angled struts interconnected interconnected by by a plurality a plurality of substantially of substantially straight, straight, axially axially extending extending struts; struts; and and wherein the wherein the outflow outflowrow rowofofopenings openingsisisformed formedbyby a circumferentiallyextending a circumferentially extendingupper upper rowrow of of angled struts angled struts arranged arranged end-to-end and aa circumferentially end-to-end and circumferentially extending secondintermediate extending second intermediaterow rowofof angled struts angled struts arranged arranged end-to-end, end-to-end, the the upper upper and and second intermediate rows second intermediate rowsofofangled angledstruts struts interconnected interconnected by by a plurality a plurality of axially of axially extending extending struts struts and a plurality and a plurality of angularly of angularly spaced, spaced,

axially extending axially extending commissure window commissure window frame frame portions, portions, wherein wherein eacheach axially axially extending extending strut strut and and

each commissure each commissurewindow window frame frame portion portion of the of the outflow outflow row row of openings of openings extends extends from from a location a location

defined by defined by the the convergence convergenceofofthe the lower lowerends endsofoftwo twoangled angledstruts struts of of the the upper row of upper row ofangled angled

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struts to struts to another defined locationdefined another location by the by the convergence convergence of theends of the upper upper ends of two of two angled angled struts of struts of the second the rowofofangled intermediate row second intermediate angledstruts. struts

.

[0014] There

[0014] disclosed herein also disclosed Thereisis also an assembly herein an assembly for implanting aa balloon-expandable for implanting balloon-expandable prostheticaortic prosthetic aorticheart heartvalve valve in in a patient's a patient's body, body, the the assembly assembly comprising: comprising:

a delivery a delivery apparatus apparatus comprising an elongated comprising an elongatedshaft shaft having havingananinflatable inflatable balloon; and and

a prosthetic a aorticheart prosthetic aortic heartvalve valve having having a balloon-expandable a balloon-expandable frame frame having having a radially a radially collapsedstate collapsed stateand and a radially a radially expanded expanded state,state, the frame the frame comprising: comprising:

an inflow an inflow row row of ofopenings openingsatat an an inflow inflow end endportion portion of of the the frame, frame, an outflow an outflow row rowofofopenings openingsatatananoutflow outflowend endportion portionofofthe the frame; frame; and and at least at leastone oneintermediate intermediaterow row of of openings openings between the inflow between the inflow row rowofofopenings openings and outflow and outflow row rowofofopenings; openings; wherein the wherein the inflow inflow row rowofofopenings openingsisisformed formedbybya acircumferentially circumferentiallyextending extending lowerrow lower rowof of angled angled struts struts arranged arranged end-to-end end-to-end and a circumferentially and a circumferentially extending extending first first intermediate row intermediate row of angled of angled struts struts arranged arranged end-to-end, end-to-end, the the lower andlower first and first intermediate intermediate

rowsofofangled rows angled struts struts interconnected interconnected by a plurality by a plurality of substantially of substantially straight, straight, axially axially

extendingstruts, extending struts, wherein the wherein the outflow outflowrow rowofofopenings openingsisisformed formedbybya circumferentially a circumferentiallyextending extending upper row upper rowofofangled angledstruts struts arranged end-to-end and arranged end-to-end anda acircumferentially circumferentially extending extendingsecond second intermediate row row of ofangled angled struts struts arranged end-to-end, the arranged end-to-end, the upper and second upper and second intermediate rows intermediate rows of angled of angled struts struts interconnected interconnected by a plurality by a plurality of extending of axially axially extending struts and struts and aaplurality pluralityofof angularly spaced, angularly axially spaced, extending axially commissure extending commissure window frame window frame

portions, wherein portions, each axially wherein each axially extending strut and extending strut and each each commissure window commissure window frame frame

portion of portion of the the outflow outflow row of openings row of openings extends extendsfrom froma alocation location defined definedby bythe the convergence of the convergence of the lower lower ends ends of twoof two angled angled struts struts of of the the upper rowupper row struts of angled of angled to struts to another location another location defined by by the the convergence ofthe convergence of the upper upperends endsofoftwo twoangled angledstruts struts of of the the second intermediate second intermediate row rowofofangled angledstruts; struts; and and

wherein adjacent wherein adjacent angled angledstruts struts of of the the frame form an frame form an angle angle of of at least120, at least 120°,when when

the frame the frameisisininthe theradially radiallyexpanded expanded state. state.

[0015] There

[0015] herein an disclosed herein also disclosed There isis also an assembly assembly for implanting aa balloon-expandable for implanting balloon-expandable prostheticaortic prosthetic aorticheart heartvalve valve in in a patient, a patient, thethe assembly assembly comprising: comprising:

a prosthetic a prosthetic aortic aorticheart heartvalve valvecomprising comprising aaballoon-expandable frame having balloon-expandable frame havinga aradially radially collapsed and collapsed and aa radially radially expanded state, the expanded state, theframe frame comprising: comprising:

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an inflow row an inflow row ofofopenings openingsatat an an inflow inflow end endportion portion of of the the frame; frame; an outflow an outflow row rowofofopenings openingsatatananoutflow outflowend endportion portionofofthe the frame; frame; and and at least at leastone oneintermediate intermediaterow row of of openings openings between the inflow between the inflow row rowofofopenings openings and outflow and outflow row rowofofopenings; openings; wherein the wherein the inflow inflow row rowofofopenings openingsisisformed formedbybya acircumferentially circumferentiallyextending extending lower row lower rowofofangled angledstruts struts arranged end-to-end and arranged end-to-end anda acircumferentially circumferentially extending extendingfirst first intermediate row intermediate row of angled of angled struts struts arranged arranged end-to-end, end-to-end, theandlower the lower first and first intermediate intermediate

rows of angled struts interconnected by a plurality of substantially straight, axially rows of angled struts interconnected by a plurality of substantially straight, axially

extending struts; extending struts;

wherein the wherein the outflow outflowrow rowofofopenings openingsisisformed formedbybya circumferentially a circumferentiallyextending extending upper row upper rowofofangled angledstruts struts arranged end-to-end and arranged end-to-end anda acircumferentially circumferentially extending extendingsecond second intermediate row of intermediate row of angled angled struts struts arranged end-to-end, the arranged end-to-end, the upper and second upper and second intermediate rows intermediate rows of angled of angled struts struts interconnected interconnected by a plurality by a plurality of extending of axially axially extending struts and struts and aaplurality pluralityofof angularly spaced, angularly axially spaced, extending axially commissure extending commissure window frame window frame

portion of portion of the the outflow outflow row of openings row of openings extends extendsfrom froma alocation location defined definedby bythe the convergence of the convergence of the lower lower ends ends of twoof two angled angled struts struts of of therowupper the upper row struts of angled of angled to struts to another location another location defined defined by the convergence by the ofthe convergence of the upper upper ends endsofoftwo twoangled angledstruts struts of of the the second intermediate second intermediate row rowofofangled angledstruts; struts; and and wherein whereinthe the plurality plurality of of commissure commissure

windowframe window frameportions portionseach each comprise comprise an enclosed an enclosed opening opening between between firstfirst and and second second

axially oriented side struts. axially oriented side struts.

[0016] There

[0016] herein an disclosed herein also disclosed There isis also an assembly for implanting assembly for balloon-expandable implanting aa balloon-expandable prosthetic aortic valve in a patient's body, the assembly comprising: prosthetic aortic valve in a patient's body, the assembly comprising:

a delivery a delivery apparatus apparatus comprising an elongated comprising an elongatedshaft shaft having havingananinflatable inflatable balloon, balloon, and and

a radially expandable prosthetic aortic valve adapted to be mounted on the shaft in a a radially expandable prosthetic aortic valve adapted to be mounted on the shaft in a

radially collapsed configuration for delivery into the body, the prosthetic aortic valve radially collapsed configuration for delivery into the body, the prosthetic aortic valve

comprising: comprising:

a balloon-expandable a annularframe balloon-expandable annular framehaving havingan an inflow inflow rowrow of of openings openings at at an an inflow end portion inflow end portion of of the the frame, frame, an an outflow outflow row ofopenings row of openingsatat an an outflow outflowend endportion portionofof the frame, the frame, at at least leastone oneintermediate intermediaterow row of ofopenings openings between the inflow between the inflow row rowofofopenings openings and outflow and outflow row rowofofopenings, openings,and andthree threeangularly angularlyspaced spacedcommissure commissure windows windows each each comprising ananenclosed comprising enclosedopening openingbetween between firstand first andsecond second axiallyoriented axially orientedside sidestruts; struts;

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a leaflet a leaflet structure positionedwithin structure positioned within the the frame, frame, the leaflet the leaflet structure structure comprising comprising a a plurality of plurality ofcommissure portions that commissure portions that extend outwardly outwardly through throughrespective respectivecommissure commissure windows; windows;

an annular an annularinner inner skirtpositioned skirt positioned along along an inner an inner surface surface of the;of the; and and an annular an annularouter outer skirtpositioned skirt positioned around around an outer an outer surfacesurface of the the of the frame, frame, outerthe outer skirt comprising skirt comprising an an inflow inflow edgeedge secured secured to the to the atframe frame at alocation, a first first location, an edge an outflow outflow edge secured to secured to the the frame at aa second frame at second location, location, and and an an intermediate intermediate portion portion between the inflow between the inflow

edge and edge and the the outflow outflow edge; edge; whereinwhen wherein when the the prosthetic prosthetic aorticaortic valve valve is inexpanded is in the the expanded configuration, configuration, the the intermediate portion intermediate portion of the of the outer outer skirt skirt comprises comprises slack slack in the in the direction axial axial direction between between the the inflowedge inflow edgeof of thethe outer outer skirt skirt and and the the outflow outflow edge edge of the of theskirt, outer outer and skirt, whenand the when the prostheticaortic prosthetic aorticvalve valveis iscollapsed collapsed to the to the collapsed collapsed configuration, configuration, thedistance the axial axial distance between between thethe inflow inflow edgeedge ofouter of the the outer skirt skirt and and the the outflow outflow edgeouter edge of the of the outer skirt skirt increases, reducing increases, reducingthethe slack slack in the in the outer outer skirt skirt in the in the axialaxial direction, direction, wherein wherein the outflow the outflow

edgeofofthe edge theouter outerskirt skirtcomprises comprises a plurality a plurality of alternating of alternating projections projections and notches, and notches, the the projectionsbeing projections being secured secured to the to the frameframe at theatsecond the second location, location, theskirt the outer outer skirt being being unsecured unsecured to to thethe frame frame at the at the notches. notches.

[0017] There

[0017] herein an disclosed herein also disclosed There isis also an assembly assembly for implanting aa balloon-expandable for implanting balloon-expandable prostheticaortic prosthetic aorticvalve valvein in a patient'sbody, a patient's body, the the assembly assembly comprising: comprising:

a delivery a delivery apparatus apparatus comprising an elongated comprising an elongatedshaft shaft having havingananinflatable inflatable balloon, and and

a radially a expandable radially expandable prosthetic prosthetic aortic aortic valvevalve adapted adapted to be mounted to be mounted on in on the shaft thea shaft in a radially collapsed radially collapsedconfiguration configuration for delivery for delivery intobody, into the the body, the prosthetic the prosthetic aortic aortic valve valve comprising: comprising:

a balloon-expandable a annularframe balloon-expandable annular framehaving having an an inflow inflow rowrow of of openings openings at an at an inflow inflow endend

portionofofthe portion theframe, frame, an an outflow outflow row row of of openings openings at an outflow at an outflow end end portion of portion ofat the frame, theleast frame, at least one intermediate one intermediate row rowofofopenings openingsbetween between theinflow the inflow row row of of openings openings and and outflow outflow row row of of openings, and openings, and three three angularly angularly spaced spaced commissure commissure windows windows eacheach comprising comprising an enclosed an enclosed

openingbetween opening between firstfirst and and second second axially axially oriented oriented side side struts; struts; a leaflet a leaflet structure positionedwithin structure positioned within the the frame, frame, the leaflet the leaflet structure structure comprising comprising a plurality a plurality

of commissure of portionsthat commissure portions that extend extendoutwardly outwardlythrough through respectivecommissure respective commissure windows; windows;

an annular an annularinner inner skirtpositioned skirt positioned along along an inner an inner surface surface of the of theand frame frame and an annular an annularouter outer skirtpositioned skirt positioned around around an outer an outer surfacesurface of the the of the frame, frame, outerthe outer skirt skirt comprising comprising an an inflow inflow edge edge secured secured to the to the atframe frame at location, a first a first location, an edge an outflow outflow edge secured to secured to

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the frame the at aa second frame at second location, location, and and an an intermediate intermediate portion portion between the inflow between the inflow edge edge and andthe the outflow edge; outflow edge; wherein when the prosthetic aortic valve is in the expanded configuration, the wherein when the prosthetic aortic valve is in the expanded configuration, the

intermediate portion intermediate portion of the of the outer outer skirt skirt comprises comprises slack slack in the in the direction axial axial direction between between the inflow the inflow

edge of the outer skirt and the outflow edge of the outer skirt, and when the prosthetic aortic edge of the outer skirt and the outflow edge of the outer skirt, and when the prosthetic aortic

valve is collapsed to the collapsed configuration, the axial distance between the inflow edge of valve is collapsed to the collapsed configuration, the axial distance between the inflow edge of

the outer skirt and the outflow edge of the outer skirt increases, reducing the slack in the outer the outer skirt and the outflow edge of the outer skirt increases, reducing the slack in the outer

skirt in the axial direction, skirt in the axial direction,

wherein an outer diameter of the inflow end portion of the frame is smaller than an outer wherein an outer diameter of the inflow end portion of the frame is smaller than an outer

diameter of the outflow end portion of the frame. diameter of the outflow end portion of the frame.

[0018] There

[0018] There isis also also disclosed disclosed herein herein an an implantable prosthetic valve implantable prosthetic valve comprising: comprising:

an annular frame comprising a plurality of leaflet attachment portions; and an annular frame comprising a plurality of leaflet attachment portions; and

a leaflet structure positioned within the frame and secured to the leaflet attachment a leaflet structure positioned within the frame and secured to the leaflet attachment

portions of the frame, the leaflet structure comprising a plurality of leaflets, each leaflet portions of the frame, the leaflet structure comprising a plurality of leaflets, each leaflet

comprising aa body comprising bodyportion portionhaving havinga afree free outflow outflowedge, edge,two twoopposing opposing primary primary side side tabs tabs

extending from extending fromopposite oppositesides sidesofofthe the body bodyportion, portion, and and two twoopposing opposingsecondary secondary tabs,each tabs, each secondary tab secondary tab extending extendingfrom fromthe thebody bodyportion portionadjacent adjacenttotoa arespective respective primary primaryside sidetab, tab, the the secondary tabs secondary tabs extending extendingfrom fromthe thebody bodyportion portionatatopposite oppositeends endsofofthe the free free outflow outflow edge; edge; wherein the wherein the secondary secondarytabs tabsare are folded folded about aboutradially radially extending extending creases creases that that extend extend

radially from the opposite ends of the free outflow edge, such that a first portion of the radially from the opposite ends of the free outflow edge, such that a first portion of the

secondary tabs lies flat against the body portion of the respective leaflet, and the secondary tabs secondary tabs lies flat against the body portion of the respective leaflet, and the secondary tabs

are folded about axially extending creases such that a second portion of the secondary tabs are folded about axially extending creases such that a second portion of the secondary tabs

extends in a different plane than the first portion, wherein the radially extending creases and the extends in a different plane than the first portion, wherein the radially extending creases and the

axially extending creases are non-parallel. axially extending creases are non-parallel.

[0019] There is also disclosed herein an assembly for implanting a prosthetic heart valve in a

patient's body, patient's body, the theassembly assembly comprising: comprising:

a delivery a delivery apparatus apparatus comprising anelongated comprising an elongatedshaft; shaft; and and a radially expandable prosthetic heart valve adapted to be mounted on the shaft in a a radially expandable prosthetic heart valve adapted to be mounted on the shaft in a

radially collapsed configuration for delivery into the body, the prosthetic heart valve comprising radially collapsed configuration for delivery into the body, the prosthetic heart valve comprising

an annular an annular frame frame having havingananinflow inflowend endportion portiondefining definingananinflow inflowend endofofthe theframe framethat thatis is configured to configured to receive receive antegrade blood flow antegrade blood flowinto into the the prosthetic prosthetic heart heartvalve valvewhen implanted, and when implanted, and the annular the annular frame also having frame also an outflow having an outflow end endportion portiondefining definingananoutflow outflowend endofofthe theframe frame opposite the inflow end of the frame, the prosthetic heart valve also comprising a leaflet opposite the inflow end of the frame, the prosthetic heart valve also comprising a leaflet

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structure positionedwithin structure positioned the the within frame, frame, an inner an inner skirt skirt fabricfabric positioned positioned inner an along analong innerofsurface of surface

the frame, and an outer fabric skirt extending from the inflow end of the frame along an outer the frame, and an outer fabric skirt extending from the inflow end of the frame along an outer

surface of the frame to a frame attachment location; surface of the frame to a frame attachment location;

wherein the frame is adapted to shorten axially during radial expansion of the prosthetic wherein the frame is adapted to shorten axially during radial expansion of the prosthetic

valve, thereby increasing axial slack in the outer fabric skirt; and valve, thereby increasing axial slack in the outer fabric skirt; and

wherein the outer fabric skirt comprises an edge defining a plurality of alternating wherein the outer fabric skirt comprises an edge defining a plurality of alternating

projections and notches that is attached to the frame at the frame attachment location. projections and notches that is attached to the frame at the frame attachment location.

[0020] There is also disclosed herein an assembly for implanting a prosthetic heart valve in a

patient's body patient's body comprising: comprising:

a delivery a delivery apparatus apparatus comprising an elongated comprising an elongatedshaft; shaft; a radially expandable and collapsible prosthetic heart valve mounted on the shaft in a a radially expandable and collapsible prosthetic heart valve mounted on the shaft in a

an annular frame and a leaflet structure within the frame; an annular frame and a leaflet structure within the frame;

wherein the wherein the frame framecomprises comprisesa aplurality plurality of of angularly angularly spaced spaced commissure commissure windows windows eacheach

comprising ananenclosed comprising enclosedopening openingbetween between firstand first andsecond second axiallyoriented axially orientedside sidestruts, struts, and and the the frame furthercomprises frame further comprises intermediate intermediate side struts side struts that that are are axially axially oriented oriented and positioned and positioned

angularly between angularly betweenthe the commissure commissure windows, windows, and and the leaflet the leaflet structurecomprises structure comprises a pluralityofof a plurality

commissureportions commissure portionsthat thatextend extendoutwardly outwardlythrough through respectivecommissure respective commissure windows windows to to locations outside of the frame; and locations outside of the frame; and

wherein the wherein the commissure commissure windows windows are are depressed depressed radially radially inwardly inwardly relative relative to to thethe

intermediate sidestruts intermediate side strutswhen when the prosthetic the prosthetic heart heart valve valve is radially is radially collapsed collapsed on thesuch on the shaft, shaft, such that an outermost surface of each commissure portion of the leaflet structure outside of the that an outermost surface of each commissure portion of the leaflet structure outside of the

frame frame isisat atsubstantially substantiallythethesame same radial radial distance distance from from a longitudinal a longitudinal center center axis axisprosthetic of the of the prosthetic heart valve as outer surfaces of the intermediate side struts. heart valve as outer surfaces of the intermediate side struts.

[0021] There is also disclosed herein an implantable prosthetic valve that is radially collapsible

to aa collapsed to collapsed configuration configuration and and radially radially expandable expandable to to an an expanded configuration, the expanded configuration, the prosthetic valve prosthetic valve comprising: comprising:

an annular an annular frame frame having havingaalongitudinal longitudinal axis axis extending extending between betweenananinflow inflowendendofofthe the frame andan an frame and outflow outflow endtheofframe end of the frame and defining and defining an axial an axial direction, direction, the inflow the end inflow of the end of the

frame being configured frame being configuredtoto receive receive antegrade antegrade blood bloodflow flowinto intothe the prosthetic prosthetic valve when valve when

implanted; implanted;

a leaflet structure positioned within the frame; and a leaflet structure positioned within the frame; and

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an annular outer skirt positioned around an outer surface of the frame, the outer skirt an annular outer skirt positioned around an outer surface of the frame, the outer skirt

comprising an inflow edge positioned at a first location at the inflow end of the frame, an comprising an inflow edge positioned at a first location at the inflow end of the frame, an

outflow edge defining a plurality of spaced apart axial projections that are secured to the frame outflow edge defining a plurality of spaced apart axial projections that are secured to the frame

at aa second at second location location axially axiallyspaced spaced from from the the inflow inflow edge, edge, and and an an intermediate intermediate portion portion extending extending

betweenthe between the inflow inflowedge edgeand andthe theoutflow outflowedge edgeandand positioned positioned outsideof of outside theframe; the frame; wherein when wherein whenthethevalve valveisisin in the the expanded configuration, the expanded configuration, the intermediate intermediate portion portion ofofthe the outer skirt comprises slack in the axial direction between the inflow edge of the outer skirt and outer skirt comprises slack in the axial direction between the inflow edge of the outer skirt and

the outflow edge of the outer skirt, and when the valve is collapsed to the collapsed the outflow edge of the outer skirt, and when the valve is collapsed to the collapsed

configuration, the distance between the inflow edge of the outer skirt and the outflow edge of configuration, the distance between the inflow edge of the outer skirt and the outflow edge of

the outer skirt increases, reducing the slack in the outer skirt in the axial direction. the outer skirt increases, reducing the slack in the outer skirt in the axial direction.

[0022] There is also disclosed herein an assembly for implanting a prosthetic heart valve in a

patient's body, patient's body, the the assembly comprising: aa delivery assembly comprising: delivery apparatus apparatus comprising comprisingananelongated elongatedshaft; shaft;aa radially expandable and collapsible prosthetic heart valve mounted on the shaft in a radially radially expandable and collapsible prosthetic heart valve mounted on the shaft in a radially

collapsed configuration for delivery into the body, the prosthetic heart valve comprising an collapsed configuration for delivery into the body, the prosthetic heart valve comprising an

annular frame and a leaflet structure within the frame; wherein the frame comprises a plurality annular frame and a leaflet structure within the frame; wherein the frame comprises a plurality

of angularly of angularly spaced commissurewindows spaced commissure windows eacheach comprising comprising an enclosed an enclosed opening opening between between first first and second axially oriented side struts, and the leaflet structure comprises a plurality of and second axially oriented side struts, and the leaflet structure comprises a plurality of

commissureportions commissure portionsthat thatextend extendoutwardly outwardlythrough through respectivecommissure respective commissure windows; windows; and and wherein the wherein the commissure commissurewindows windows are are depressed depressed radially radially inwardly inwardly relative relative to to portions portions of of

the frame the betweenadjacent frame between adjacentcommissure commissure windows windows when when the valve the valve is radially is radially collapsed collapsed on on the the shaft. shaft.

[0023] There

[0023] disclosed herein also disclosed Thereisis also an implantable herein an prosthetic valve, implantable prosthetic comprising: an valve, comprising: an annular annular

frame comprising frame comprising a plurality a plurality of leaflet of leaflet attachment attachment portions; portions; and an structure and an leaflet leaflet structure positionedpositioned

within the frame and secured to the leaflet attachment portions of the frame, the leaflet structure within the frame and secured to the leaflet attachment portions of the frame, the leaflet structure

comprising a plurality of leaflets, each leaflet comprising a body portion, two opposing primary comprising a plurality of leaflets, each leaflet comprising a body portion, two opposing primary

side side tabs tabs extending extending from opposite sides from opposite sides of of the the body body portion, portion, and and two opposingsecondary two opposing secondarytabs tabs extending from extending fromthe thebody bodyadjacent adjacenttotothe the primary primaryside side tabs; tabs; wherein the secondary wherein the secondarytabs tabs are are folded folded about a radially extending crease such that a first portion of the secondary tabs lies flat against about a radially extending crease such that a first portion of the secondary tabs lies flat against

the body portion of the respective leaflet, and the secondary tabs are folded about an axially the body portion of the respective leaflet, and the secondary tabs are folded about an axially

extending crease such that a second portion of the secondary tabs extends in a different plane extending crease such that a second portion of the secondary tabs extends in a different plane

than the first portion. than the first portion.

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[0024]

[0024]There Thereis is also disclosed also herein disclosed an implantable herein prosthetic an implantable valve, comprising: prosthetic a radially valve, comprising: a radially and expandable collapsible and collapsible annularframe expandable annular comprising framecomprising a pluralityofofangularly a plurality spaced angularly spaced windows commissurewindows commissure eacheach comprising comprising an enclosed an enclosed opening opening between between firstsecond first and and second axially axially

orientedside oriented sidestruts; struts;a aleaflet leafletstructure structurepositioned positioned within within the frame the frame and comprising and comprising a plurality a plurality of of leaflets each leaflets eachcomprising comprisingtwo two opposing opposing sideeach side tabs, tabs,side each tabside beingtab being paired paired with with an an adjacent adjacent side side tab of tab of an anadjacent adjacentleaflet leaflettotoform form commissures commissures of the of the leaflet leaflet structure, structure, each each pair pair tabs of side of side tabs extending radially extending radially outwardly throughaacorresponding outwardly through correspondingcommissure commissure window window to a location to a location outside outside

of the of the frame, frame,the theportions portions of of thethe tabs tabs located located outside outside of theofframe the frame extend circumferentially extend circumferentially away away fromone from oneanother another and and alongalong an exterior an exterior surfacesurface of the of the side side struts; struts; and a plurality and a plurality ofeach of wedges, wedges, each wedgebeing wedge beingpositioned positionedbetween betweenthethe sidestruts side strutsof ofaa commissure commissurewindow window and and separating separating the the pairpair

of side of side tabs tabs extending extending through through the the commissure window, commissure window, thethe wedge wedge being being urged urged radially radially

inwardlyagainst inwardly against thethe side side tabs. tabs.

[0025] There

[0025]There is is also also disclosed disclosed herein herein an implantable an implantable prosthetic prosthetic valve valve that is radially radially collapsible that is collapsible to aa collapsed to collapsed configuration configuration and and radially radially expandable expandable to to an an expanded configuration, the expanded configuration, the prosthetic valve prosthetic valve comprising: an annular comprising: an annular frame frame having havingananinflow inflowend endportion portionand andananoutflow outflowendend portion; aaleaflet portion; leaflet structure structurepositioned positioned within within the frame; the frame; and anand an annular annular inner inner skirt skirt positioned positioned

withinthe within theframe, frame,thethe inner inner skirt skirt being being secured secured to thetoinside the inside of the of the frame, frame, theskirt the inner inner skirt comprising comprising a weave a weave of a of a first first setstrands set of of strands with with a second a second set of strands, set of strands, both theboth firstthe andfirst and secondsets second setsofof strands strands being being non-parallel non-parallel withaxial with the the direction axial direction of the wherein of the valve; valve; when wherein the when the valveisis collapsed valve collapsedfrom from the the expanded expanded configuration configuration to the collapsed to the collapsed configuration, configuration, the axial the axial lengthofofthe length theframe frame increases increases and and the both the both the first the first and second and second sets of sets of strands strands rotatethetoward rotate toward the axial direction axial directionofofthe thevalve, valve,allowing allowing the the innerinner skirtskirt to elongate to elongate in thein the direction axial axial direction along along with with the frame. the

[0026] exemplary Anexemplary

[0026] An of anofassembly embodiment embodiment an assembly for implanting for implanting a prosthetic heartheart a prosthetic valvevalve in ain a patient's body patient's comprises aa delivery body comprises delivery apparatus apparatus comprising comprisingananelongated elongatedshaft shaftand anda aradially radially expandable expandable prosthetic prosthetic heart heart valvevalve mounted mounted on the on the shaft in shaft in a radially a radially collapsed collapsed configuration configuration for for delivery into delivery into the thebody. The prosthetic body. The prosthetic heart heart valve valve comprises an annular comprises an annular frame framehaving havingananinflow inflow endportion end portionandand an an outflow outflow end portion, end portion, and a leaflet and a leaflet structure structure positioned positioned within thewithin frame. the The frame. The outer diameter outer diameterof of thethe inflow inflow end end portion portion of theof the is frame frame is smaller smaller than the than outerthe outer of diameter diameter the of the outflow end outflow endportion portion of of the the frame. The Thereduced reduceddiameter diameter of of theinflow the inflowend endcan canbebeduedue to to a a reduce amount reduce amountofofmaterials materialspositioned positionedwithin withinthe theinflow inflowend endportion portionofofthe the frame. frame. The Thereduced reduced diameter at diameter at the the inflow inflow end end portion portion can can make roomforforananouter make room outerskirt skirt positioned positioned around around the the inflow end end portion. portion.

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In some

[0027] In

[0027] embodiments, someembodiments, thethe heart heart valve cancan valve furthercomprise further an an comprise outer outer skirt positioned skirtpositioned aroundanan around outer outer surface surface of the of the inflow inflow end portion end portion of the of thesuch frame frame thatsuch that diameter an outer an outerofdiameter an of an inflow endportion inflow end portion of the of the prosthetic prosthetic valve, valve, inclusive inclusive of theof the skirt, outer outer skirt, is less is still still than less or than or equal equal

2023208213 28

to an to an outer outerdiameter diameterof of an an outflow outflow end portion end portion of the of the prosthetic prosthetic valve. valve.

[0028]InInsome

[0028] some embodiments, embodiments, the leaflet the leaflet structure structure can comprise a pluralityaof can comprise leaflets of plurality leaflets that each that each comprisesopposing comprises opposing side side tabs tabs on opposite on opposite sides sides of of the leaflet. the leaflet. The side The tabs side tabs can be can be secured to secured to the outflow the end portion outflow end portion of of the the frame. Eachleaflet frame. Each leaflet can further comprise can further a free comprise a free outflow outflow edge edge

portion extending portion extending between betweenthe theside side tabs tabs adjacent adjacent to to the the outflow end of outflow end of the frame and an frame and an inflow inflow edge portion edge portion extending extending between betweenthe theside sidetabs tabs adjacent adjacent to to the the inflow end of the end of the frame. The frame. The

inflow edge edge portion portion can can comprise compriseopposing opposing axialedge axial edgeportions portionsthat thatextend extendfrom fromthe theside sidetabs tabs towardthe toward theinflow inflow end end in ain a generally generally axial axial direction direction and an and an intermediate intermediate edge edge portion portion that that extends between extends betweenthe theaxial axial edge edge portions. portions. The Theintermediate intermediateedge edgeportion portioncan cancomprise comprise a curved a curved

apexportion apex portionadjacent adjacent to the to the inflow inflow end end of theof the frame frame andofa pair and a pair of portions oblique oblique that portions extendthat extend betweenthe between the axial axial edge edge portions portions and and the the apex apex portion. portion. The Theoblique obliqueportions portionscan canhave havea agreater greater radius of radius ofcurvature curvature than than thethe apexapex portion, portion, forming forming a generally a generally V-shaped V-shaped leaflet. leaflet.

someembodiments, In some

[0029] In

[0029] embodiments,thethe frame frame comprises comprises a plurality of of a plurality angularly angularly spaced spaced commissure commissure

windowseach windows eachcomprising comprising an an enclosed enclosed opening opening between between firstfirst and and second second axially axially oriented oriented sideside

struts. In struts. In these theseembodiments, embodiments, the leaflet the leaflet structure structure comprises comprises a plurality a plurality of leaflets of leaflets each each comprising comprising twotwo opposing opposing side each side tabs, tabs,side eachtabside tabpaired being beingwith paired with anside an adjacent adjacent side tab of an tab of an adjacent leaflet adjacent leaflettotoform formcommissures ofthe commissures of the leaflet leafletstructure. structure.Each Each commissure extendsradially commissure extends radially outwardly through outwardly througha acorresponding correspondingcommissure commissure window window of theofframe the frame to a location to a location outside outside of of the the frame and is frame and is sutured sutured to to the the side sidestruts strutsofof thethe commissure commissure window. In some window. In someofofthese these embodiments,the embodiments, thecommissure commissure windows windows offrame of the the frame are depressed are depressed radially radially inwardly inwardly relative relative to to the portions of the of the theframe frame extending extending between adjacent commissure between adjacent commissure windows windows when when the prosthetic the prosthetic

valveisis in valve in the the collapsed collapsedconfiguration configuration onshaft. on the the shaft.

In some

[0030] In

[0030] embodiments, someembodiments, thethe frame frame comprises comprises an inflow row row an inflow of openings of openings at the the inflow at inflow end end portionofofthe portion theframe, frame, an an outflow outflow row row of of openings openings at the outflow at the outflow end end portion of portion of and the frame, the at frame, and at least one least one intermediate intermediate row of openings row of betweenthe openings between theinflow inflowrow rowofofopenings openingsandand outflow outflow rowrow of of openings. The openings. Theopenings openingsof of theinflow the inflowrow row of of openings openings areare largerthan larger thanthe theopenings openingsofof theatat the

least one least one intermediate intermediate row of openings. row of

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In some

[0031] In

[0031] embodiments, someembodiments, of of portions portions thethe leaflet structure protrude leaflet structure openingsininthe throughopenings protrude through the frame while in the collapsed configuration on the shaft. frame while in the collapsed configuration on the shaft.

In some

[0032] In

[0032] embodiments, someembodiments, thethe inflow endend inflow portion of of portion thethe frame frame comprises comprises a frame a frame thickness thickness

that is less than a frame thickness of an intermediate portion of the frame between the inflow that is less than a frame thickness of an intermediate portion of the frame between the inflow

end portion end portion and and the the outflow outflow end endportion. portion.

[0033] Embodiments

[0033] Embodiments disclosed disclosed here cancan here comprise comprise an implantable an implantable prosthetic prosthetic valve thatthat valve is is radially collapsible to a collapsed configuration and radially expandable to an expanded radially collapsible to a collapsed configuration and radially expandable to an expanded

configuration. Such prosthetic valves can comprise an annular frame, a leaflet structure configuration. Such prosthetic valves can comprise an annular frame, a leaflet structure

positioned within the frame, and an annular outer skirt positioned around an outer surface of the positioned within the frame, and an annular outer skirt positioned around an outer surface of the

frame. The frame. The outer outer skirt skirt can can comprise comprise an inflow an inflow edgetosecured edge secured to at the frame thea frame at a firstanlocation, an first location,

outflow edge outflow edgesecured securedtoto the the frame frame atat aa second location, and second location, an intermediate and an portion between intermediate portion the between the

inflow edge and inflow edge and the the outflow outflow edge. edge. When Whenthe the valve valve is is ininthe theexpanded expanded configuration,thethe configuration,

edge of the outer skirt and the outflow edge of the outer skirt, and when the valve is collapsed to edge of the outer skirt and the outflow edge of the outer skirt, and when the valve is collapsed to

the collapsed configuration, the axial distance between the inflow edge of the outer skirt and the the collapsed configuration, the axial distance between the inflow edge of the outer skirt and the

outflow edge of the outer skirt increases, reducing the slack in the outer skirt in the axial outflow edge of the outer skirt increases, reducing the slack in the outer skirt in the axial

direction. direction.

[0034] In some of these embodiments, the outer skirt is not stretched in the axial direction when

the valve is radially collapsed to the collapsed configuration and slack is removed from the the valve is radially collapsed to the collapsed configuration and slack is removed from the

intermediate portion intermediate portion of the of the outer outer skirt. skirt.

[0035] embodiments Someembodiments

[0035] Some of an an implantable ofimplantable prosthetic prosthetic valve valve comprise comprise an annular frameframe an annular comprising a plurality of leaflet attachment portions, and a leaflet structure positioned within the comprising a plurality of leaflet attachment portions, and a leaflet structure positioned within the

frame andsecured frame and secured to the to the leaflet leaflet attachment attachment portions portions of the of the The frame. frame. Thestructure leaflet leaflet structure comprises a plurality of leaflets, each leaflet comprising a body portion, two opposing primary comprises a plurality of leaflets, each leaflet comprising a body portion, two opposing primary

side tabs side tabs extending extending from opposite sides from opposite sides of of the the body body portion, portion, and and two opposingsecondary two opposing secondarytabs tabs extending from extending fromthe thebody bodyadjacent adjacenttotothe the primary primaryside side tabs. tabs. The Thesecondary secondarytabs tabsare arefolded foldedabout about a radially extending crease such that a first portion of the secondary tabs lies flat against the a radially extending crease such that a first portion of the secondary tabs lies flat against the

body portion of the respective leaflet, and the secondary tabs are folded about an axially body portion of the respective leaflet, and the secondary tabs are folded about an axially

than the first portion. The second portion of each secondary tab is sutured to a respective than the first portion. The second portion of each secondary tab is sutured to a respective

primary tab and the secondary tabs are positioned inside of the frame. primary tab and the secondary tabs are positioned inside of the frame.

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someofofthese In some

[0036] In

[0036] embodiments, these embodiments, thethe first portion first the secondary each the of each portion of tab pivots secondary tab about pivots about the axially the axially extending extending crease crease and and lays lays flat flat against against the second the second portionportion of the secondary of the secondary tab when tab when the valve the valveisiscollapsed collapsedto to a radially a radially collapsed collapsed configuration. configuration. Theportion The first first portion of each secondary of each secondary

tab comprises tab an inner comprises an inner edge edge spaced spacedradially radially from from ananinner inner surface surface of of the the frame, and the body and the body

portionofofthe portion theleaflet leafletarticulates articulatesabout about thethe inner inner edges edges oftwo of the thesecondary two secondary tabsleaflet tabs of the of theinleaflet in responsetotoblood response blood flowing flowing through through the when the valve valvethewhen valve the valve is in is in operation operation within within a patient's a patient's body. body.

[0037] embodiments Someembodiments

[0037] Some disclosed disclosed herein herein comprise comprise an implantable an implantable prosthetic that that valvevalve prosthetic is is radially collapsible radially collapsibletotoa acollapsed collapsed configuration configuration and radially and radially expandable expandable to an to an expanded expanded configuration. The configuration. Theprosthetic prosthetic valve valve comprises comprisesananannular annularframe framehaving having an an inflow inflow endend portion portion

andananoutflow and outflowendend portion, portion, a leaflet a leaflet structure structure positioned positioned within within the and the frame, frame, and aninner an annular annular inner skirt positioned skirt within positioned within thethe frame. frame. The inner The inner skirt skirt is is secured secured to the of to the inside inside of theandframe the frame the and the inner skirt inner skirt comprises comprises a weave a weave of a of a first first setstrands set of of strands with with a second a second set of strands, set of strands, both theboth firstthe first andsecond and second sets sets of of strands strands being being non-parallel non-parallel with with the thedirection axial axial direction of theWhen of the valve. valve. the When the valveisis collapsed valve collapsedfrom from the the expanded expanded configuration configuration to the collapsed to the collapsed configuration, configuration, the axial the axial lengthofofthe length theframe frame increases increases and and the both the both the first the first and second and second sets of sets of strands strands rotatethetoward rotate toward the axial direction axial directionofofthe thevalve, valve,allowing allowing the the innerinner skirtskirt to elongate to elongate in thein the direction axial axial direction along along with with the frame. the frame.

[0038]InInsome

[0038] some of these of these embodiments, embodiments, thesetfirst the first set of strands of strands are substantially are substantially perpendicular perpendicular to to the second the set of strands second set strands when the valve is when the is in inthe theexpanded expanded configuration. In some configuration. In some

embodiments, embodiments, the the firstfirst set set of strands of strands forms forms a first a first angleangle with with the the direction axial axial direction of the of the valve valve and and the second the secondsetsetofof strands strands forms forms a second a second angle angle with with the thedirection axial axial direction of thethevalve, of the valve, first the and first and second angles second angles being beingsubstantially substantially equal. equal. In In some ofthese some of these embodiments, embodiments, thefirst the first and and second second sets of sets of strands strands comprise comprise 20-denier 20-denier yarn.yam.

Someembodiments

[0039] Some

[0039] embodiments ofimplantable of an an implantable prosthetic prosthetic valve valve comprise comprise a radially a radially collapsible collapsible

and expandable and expandableannular annularframe framecomprising comprising a pluralityofofangularly a plurality angularlyspaced spacedcommissure commissure windows windows

each comprising each comprisingananenclosed enclosedopening opening between between firstandand first second second axiallyoriented axially orientedside sidestruts. struts. The The valvealso valve alsocomprises comprises a leaflet a leaflet structure structure positioned positioned withinwithin theand the frame frame and comprising comprising a plurality a ofplurality of leaflets each leaflets eachcomprising comprisingtwo two opposing opposing sideEach side tabs. tabs.sideEach side tab is tab is paired paired with with an an adjacent adjacent side side tab of tab of an anadjacent adjacentleaflet leaflettotoform form commissures commissures of the of the leaflet leaflet structure. structure. Each Each pair pairtabs of side of side tabs extends radially extends radially outwardly through aa corresponding outwardly through correspondingcommissure commissure window window to a to a location location outside outside of of the frame, the frame,the theportions portions of of thethe tabs tabs located located outside outside of theofframe the frame extending extending circumferentially circumferentially away away

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15 Jul 2023

from oneanother from one another and and alongalong an exterior an exterior surfacesurface of the of the side side struts. struts. The valveThe valvecomprises further further acomprises a plurality of plurality ofwedges, wedges, each each wedge beingpositioned wedge being positionedbetween between theside the sidestruts struts of of aa commissure commissure windowand window and separatingthe separating thepair pairofofside side tabs tabs extending extending through throughthe the commissure commissure window, window, the the 2023208213 28

wedgebeing wedge being urged urged radially radially inwardly inwardly againstagainst the sidethe side tabs. tabs.

[0040] The

[0040] wedges Thewedges can be be can in in elongated elongated an an axialdirection axial correspond andcorrespond directionand in in axiallength axial withanan lengthwith axial length axial length of ofthe theside sidestruts of of struts thethe commissure commissurewindows. Thewedges windows. The wedges can can furtherrestrict further restrict rotational movement rotational movement ofofthe thepair pair of of side side tabs tabs relative relativetoto thethe commissure commissure window. Eachwedge window. Each wedge can be can besutured suturedto to a flexible a flexible reinforcing reinforcing sheet sheet that that is also is also sutured sutured to of to each each the of theofpair pair sideof side tabs, tabs, and each and each can can be be sutured sutured to to the the pair pair of ofside sidetabs. tabs.The The wedges can comprise wedges can comprisea anon-metallic non-metallic material, such material, suchasassuture suture material. material.

[0041] The

[0041] foregoingand Theforegoing otherobjects, andother features, and objects, features, and advantages the invention ofthe advantages of will become invention will become

moreapparent more apparentfrom fromthe thefollowing followingdetailed detaileddescription, description, which whichproceeds proceedswith withreference referencetotothe the accompanyingfigures. accompanying figures.

BRIEF DESCRIPTION BRIEF OFTHE DESCRIPTION OF THEDRAWINGS DRAWINGS

[0042] Preferred

[0042] Preferred embodiments embodiments of of thethepresent presentinvention inventionwill willnow nowbe be described,byby described, wayway of of exampleonly, example only, with withreference reference to to the the accompanying accompanying drawing, drawing, in in which: which:

[0043] FIGS.1-3

[0043] FIGS. showan an 1-3show exemplary exemplary embodiment embodiment of a prosthetic of a prosthetic heartheart valve. valve.

4-10show FIGS.4-10

[0044] FIGS.

[0044] showan an exemplary exemplary frame frame of the of the heart heart valve of of valve FIG. FIG. 1. 1.

[0045] 11-15B FIGS.11-15B

[0045] FIGS. show show another another exemplary frameframe exemplary for use usea in for in a prosthetic prosthetic heart heart valve. valve.

[0046] FIGS

[0046] andand 16A FIGS16A showshow 16B16B an exemplary an exemplary skirt skirt inner inner of the of the heart heart valve valve of FIG. of FIG. 1. 1.

[0047] 17 shows FIG. 17

[0047] FIG. showsanother of aof embodiment anotherembodiment a prosthetic prosthetic heart heart valve in in valve a compressed a compressed

(crimped) condition with (crimped) condition withaa deformed deformedframe. frame.

FIG. 18

[0048] FIG.

[0048] showsthe 18 shows theheart FIG.1 1in valveofofFIG. heartvalve in aa compressed andmounted stateand compressedstate mountedon on an an exemplaryballoon exemplary ballooncatheter. catheter.

[0049] FIGS.

[0049] 19-20show FIGS.19-20 thethe show assembly assembly of the of the inner inner skirt FIG.16A skirtofofFIG. 16A with thethe with frame of of frame FIG. FIG. 4. 4.

AH25(42477228_1):BJM

16 Jul 2023

[0050] FIGS.21-28

[0050] FIGS. thethe show 21-28show assembly assembly of an of an exemplary exemplary leaflet leaflet structure. structure.

[0051] FIGS.

[0051] 29-35show FIGS.29-35 thethe show assembly assembly of commissure of commissure portions portions of the the leaflet of leaflet structure with structurewith 2023208213 28 windowframe window frame portionsofofthe portions theframe. frame.

[0052] FIGS. 36-40 show the assembly of the leaflet structure with the inner skirt along a lower

edge of the leaflets. edge of the leaflets.

[0053] FIG. 41 shows an exemplary outer skirt laid out flat.

[0054] FIGS.

[0054] and4343show FIGS.4242and thethe show exemplary exemplary prosthetic prosthetic heart heart valve of of valve FIG. FIG. 1. 1.

[0055] FIGS.

[0055] 44-48show FIGS.44-48 an an show alternative of aof embodiment alternativeembodiment a prosthetic prosthetic heart heart valve. valve.

[0056] FIGS.

[0056] show 49-52show FIGS.49-52 portions an an of of portions alternative embodiment alternativeembodiment of aofframe. a frame.

[0057] FIG. 53 shows a portion of the frame of FIG. 4 in a radially compressed state.

[0058] FIG.

[0058] showsa across-sectional 54 shows FIG. 54 cross-sectionalprofile of the frame profile of of FIG frame of FIG 4, showings a ageneral 4, showings general tapering from tapering the outflow from the end to outflow end to the the inflow inflow end. end.

[0059] FIG. 55 shows the frame of FIG. 4 in an unrolled, flat configuration.

FIG. 56

[0060] FIG.

[0060] showsthe 56 shows heartvalve theheart FIG.1 1inin aa compressed valveofofFIG. andmounted stateand compressedstate mountedon on an an exemplaryballoon exemplary ballooncatheter. catheter.

[0061] FIGS.

[0061] FIGS.5757and and5858shows shows an an embodiment embodiment of a of a leaflet leaflet have have a generally a generally V-shaped V-shaped

configuration. configuration.

[0062] FIG.

[0062] FIG. 59 showsa across-sectional 59 shows viewofofananalternative cross-sectionalview embodiment alternative embodiment of of a prosthetic valve a prostheticvalve having aa variable having variable thickness thickness frame. frame.

[0063] 60 isis aa side FIG. 60

[0063] FIG. side view of an view of embodiment ofof an embodiment valvehaving frameofofa avalve a aframe commissure havingcommissure windows, prior to mounting a leaflet structure to the frame. windows, prior to mounting a leaflet structure to the frame.

[0064] FIG.

[0064] 60Aisisananenlarged FIG. 60A viewofofone sideview enlargedside commissure onecommissure window window of60. of FIG FIG 60.

AH25(42477228_1):BJM

17 Jul 2023

[0065] FIG.

[0065] FIG. 61 61 isis aa perspective perspective view of an view of an embodiment embodiment of of a a prostheticvalve prosthetic valvecomprising comprising the the

frame frame ofof FIG. FIG. 60 60 and and a leaflet a leaflet structure structure mounted mounted to the valve. to the valve.

2023208213 28

[0066] FIG.

[0066] 62 isis an FIG. 62 an enlarged side view enlarged side of one view of commissureof of one commissure the valveofofFIG. thevalve 61. FIG.61.

[0067] FIGS.

[0067] FIGS.63-71 63-71are arecross-sectional cross-sectional views viewsofofaa commissure commissureof of thethevalve valveofofFIG. FIG.6161showing showing varioustechniques various techniquesfor for suturing suturing a pair a pair of leaflet of leaflet side side tabs tabs to a commissure to a commissure window window using a using a reinforcingsheet. reinforcing sheet.

72-74show FIGS.72-74

[0068] FIGS.

[0068] show balloon balloon expansion expansion of an an alternative of alternative embodiment of a of embodiment frame for afor a frame a prosthetic valve prosthetic valve having inflow and having inflow and outflow outflowend endportions portionsofofreduced reducedthickness. thickness.

DETAILED DESCRIPTION DETAILED DESCRIPTION OF OF THE THE EMBODIMENTS EMBODIMENTS

[0069] 1-3show FIGS.1-3

[0069] FIGS. showvarious of of views variousviews a prosthetic valve10, heartvalve a prostheticheart 10, according one accordingtotoone embodiment.TheThe embodiment. illustratedvalve illustrated valveisisadapted adaptedtotobe beimplanted implantedininthe the native native aortic aortic annulus, annulus,

although in although in other other embodiments embodiments ititcan canbebeadapted adaptedtotobebeimplanted implantedininthe theother other native native annuluses annuluses of of the heart. the heart. The valve 10 The valve 10 can can have have four four main maincomponents: components: a stent,ororframe, a stent, frame,12,12,a avalvular valvular structure 14,ananinner structure 14, innerskirt skirt16,16,andand an an outer outer skirt skirt 18. 18.

The

[0070]The

[0070] valvular valvular structure structure 14 can can comprise 14comprise three leaflets three leaflets 40, collectively forming a forming 40, collectively leaflet a leaflet structure, whichcancan structure, which be be arranged arranged to collapse to collapse in a tricuspid in a tricuspid arrangement, arrangement, as best as best shown shown in FIG. 2. in FIG. 2.

The lower The loweredge edgeofofleaflet leaflet structure structure 14 14 desirably desirablyhas has an anundulating, undulating, curved curved scalloped scalloped shape shape

(suture line 154 (suture line 154shown shown in FIG. in FIG. 1 tracks 1 tracks the scalloped the scalloped shape shape of of the structure). the leaflet leaflet structure). By formingBy forming

the leaflets the leaflets with withthis thisscalloped scallopedgeometry, geometry, stresses stresses on theon the leaflets leaflets are reduced, are reduced, which inwhich turn in turn improvesdurability improves durability of the of the valve. valve. Moreover, Moreover, byofvirtue by virtue of the scalloped the scalloped shape, shape, folds folds and ripples and ripples at the at the belly ofeach belly of eachleaflet leaflet(the (thecentral centralregion region of of eacheach leaflet), leaflet), which which can cause can cause early calcification early calcification

in those in those areas, areas,can canbe beeliminated eliminated or oratatleast minimized. least minimized. The The scalloped scalloped geometry also reduces geometry also reduces the the amount amount of of tissue tissue material material usedused to form to form leaflet leaflet structure, structure, thereby thereby allowingallowing a smaller,a more smaller, even more even crimpedprofile crimped profile at at thethe inflow inflow end end ofvalve. of the the valve. The leaflets The leaflets 40 formed 40 can be can beofformed of pericardial pericardial

tissue (e.g., tissue (e.g., bovine pericardialtissue), bovine pericardial tissue),biocompatible biocompatible synthetic synthetic materials, materials, or various or various other other suitable natural suitable naturalororsynthetic synthetic materials materials as known as known in the in the art andart and described described in U.S.No.Patent in U.S. Patent No. 6,730,118, which whichisis incorporated incorporated by by reference reference herein. herein.

AH25(42477228_1):BJM

18 28 Jul 2023

[0071] The

[0071] Thebare bareframe frame1212isis shown shownininFIG. FIG.4.4.TheThe frame frame 12 can 12 can be be formed formed withwith a plurality a plurality of of circumferentially spaced circumferentially slots, ororcommissure spaced slots, windows,2020(three commissure windows, (threeininthe the illustrated illustrated embodiment) embodiment)

that are adapted to mount the commissures of the valvular structure 14 to the frame, as described that are adapted to mount the commissures of the valvular structure 14 to the frame, as described

in greater detail below. The frame 12 can be made of any of various suitable plastically in greater detail below. The frame 12 can be made of any of various suitable plastically-

expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) as

2023208213 knownininthe known theart. art. When Whenconstructed constructedofofa aplastically-expandable plastically-expandablematerial, material, the theframe frame1212(and (andthus thus the valve 10) can be crimped to a radially compressed state on a delivery catheter and then the valve 10) can be crimped to a radially compressed state on a delivery catheter and then

expandedinside expanded insideaa patient patient by an inflatable by an inflatable balloon balloon or orequivalent equivalentexpansion expansion mechanism. When mechanism. When

constructed of constructed of aa self-expandable material, the self-expandable material, the frame frame 12 12 (and (and thus thus the the valve valve 10) 10) can can be be crimped crimped

to a radially compressed state and restrained in the compressed state by insertion into a sheath or to a radially compressed state and restrained in the compressed state by insertion into a sheath or

equivalent mechanism equivalent mechanismof of a a deliverycatheter. delivery catheter. Once Onceinside insidethe thebody, body,the thevalve valvecan canbebeadvanced advanced from the delivery sheath, which allows the valve to expand to its functional size. from the delivery sheath, which allows the valve to expand to its functional size.

[0072] Suitable plastically-expandable materials that can be used to form the frame 12 include,

without limitation, stainless steel, a nickel based alloy (e.g., a cobalt-chromium or a nickel without limitation, stainless steel, a nickel based alloy (e.g., a cobalt-chromium or a nickel-

cobalt-chromiumalloy), cobalt-chromium alloy),polymers, polymers,ororcombinations combinations thereof.In In thereof. particularembodiments, particular embodiments, frame 12 is frame 12 is made ofaa nickel-cobalt-chromium-molybdenum made of nickel-cobalt-chromium-molybdenum alloy,alloy, such such as MP35NTM as MP35NTM

(tradename ofofSPS (tradename SPSTechnologies), Technologies),which which is is equivalenttotoUNS equivalent UNS R30035 R30035 (covered (covered by by ASTM ASTM TM F562-02). MP35NTM/UNS F562-02). MP35N /UNS R30035 R30035 comprises 35% 35% comprises nickel, 35%35% nickel, cobalt,20% cobalt, 20% chromium, chromium, andand

10%molybdenum, 10% molybdenum, by weight. by weight. It has It has beenbeen found found that that the the use use of MP35N of MP35N to frame to form form frame 12 12 provides superior structural results over stainless steel. In particular, when MP35N is used as provides superior structural results over stainless steel. In particular, when MP35N is used as

the frame material, less material is needed to achieve the same or better performance in radial the frame material, less material is needed to achieve the same or better performance in radial

and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less

material is required, the crimped profile of the frame can be reduced, thereby providing a lower material is required, the crimped profile of the frame can be reduced, thereby providing a lower

profile valve assembly for percutaneous delivery to the treatment location in the body. profile valve assembly for percutaneous delivery to the treatment location in the body.

[0073] Referring to FIGS. 4 and 5, the frame 12 in the illustrated embodiment comprises a first,

lower row lower rowII of of angled angled struts struts 22 22 arranged arranged end-to-end and extending end-to-end and extendingcircumferentially circumferentially atat the the inflow end of the frame; a second row II of circumferentially extending, angled struts 24; a third inflow end of the frame; a second row II of circumferentially extending, angled struts 24; a third

row III of circumferentially extending, angled struts 26; a fourth row IV of circumferentially row III of circumferentially extending, angled struts 26; a fourth row IV of circumferentially

extending, angled struts 28; and a fifth row V of circumferentially extending, angled struts 32 at extending, angled struts 28; and a fifth row V of circumferentially extending, angled struts 32 at

the outflow end of the frame. A plurality of substantially straight axially extending struts 34 can the outflow end of the frame. A plurality of substantially straight axially extending struts 34 can

be used to interconnect the struts 22 of the first row I with the struts 24 of the second row II. be used to interconnect the struts 22 of the first row I with the struts 24 of the second row II.

The fifth row V of angled struts 32 are connected to the fourth row IV of angled struts 28 by a The fifth row V of angled struts 32 are connected to the fourth row IV of angled struts 28 by a

plurality of plurality ofaxially axiallyextending extendingwindow frameportions window frame portions 3030(which (whichdefine definethe thecommissure commissure windows windows

AH25(42477228_1):BJM

19 Jul 2023

20) and a plurality of axially extending struts 31. Each axial strut 31 and each frame portion 30 20) and a plurality of axially extending struts 31. Each axial strut 31 and each frame portion 30

extends from extends fromaa location location defined defined by by the the convergence convergenceofofthe the lower lowerends endsofoftwo twoangled angledstruts struts 32 32 toto another location another location defined defined by the convergence by the ofthe convergence of the upper upper ends endsofoftwo twoangled angledstruts struts 28. 28. FIGS. FIGS.6,6, 2023208213 28

7, 8, 9 and 10 are enlarged views of the portions of the frame 12 identified by letters A, B, C, D 7, 8, 9 and 10 are enlarged views of the portions of the frame 12 identified by letters A, B, C, D

and E, respectively, in FIG. 4. and E, respectively, in FIG. 4.

[0074] commissure Eachcommissure

[0074] Each window frameframe window portion portion 30 mounts 30 mounts a respective a respective commissure commissure of the of the leaflet structure 14. As can be seen each frame portion 30 is secured at its upper and lower ends leaflet structure 14. As can be seen each frame portion 30 is secured at its upper and lower ends

to the adjacent rows of struts to provide a robust configuration that enhances fatigue resistance to the adjacent rows of struts to provide a robust configuration that enhances fatigue resistance

under cyclic under cyclic loading of the loading of the valve valve compared to known compared to knowncantilevered cantileveredstruts strutsfor for supporting supporting the the commissures of the leaflet structure. This configuration enables a reduction in the frame wall commissures of the leaflet structure. This configuration enables a reduction in the frame wall

thickness to thickness to achieve achieve a a smaller smaller crimped diameterofofthe crimped diameter the valve. valve. In In particular particular embodiments, the embodiments, the

thickness TT of thickness of the the frame 12 (FIG. frame 12 (FIG. 4) 4) measured between measured between theinner the innerdiameter diameterandand outerdiameter outer diameter is is

about 0.48 about 0.48 mm mmororless. less.

[0075] The struts and frame portions of the frame collectively define a plurality of open cells of

the frame. At the inflow end of the frame 12, struts 22, struts 24, and struts 34 define a lower the frame. At the inflow end of the frame 12, struts 22, struts 24, and struts 34 define a lower

row of cells defining openings 36. The second, third, and fourth rows of struts 24, 26, and 28 row of cells defining openings 36. The second, third, and fourth rows of struts 24, 26, and 28

define two intermediate rows of cells defining openings 38. The fourth and fifth rows of struts define two intermediate rows of cells defining openings 38. The fourth and fifth rows of struts

28 and 32, along with frame portions 30 and struts 31, define an upper row of cells defining 28 and 32, along with frame portions 30 and struts 31, define an upper row of cells defining

openings 40. The openings 40 are relatively large and are sized to allow portions of the leaflet openings 40. The openings 40 are relatively large and are sized to allow portions of the leaflet

structure 14totoprotrude, structure 14 protrude,or or bulge, bulge, intointo and/or and/or through through the openings the openings 40 when 40 when the theisframe 12 is frame 12

crimpedinin order crimped order to to minimize the crimping minimize the crimpingprofile. profile.

[0076] As best shown in FIG. 7, the lower end of the strut 31 is connected to two struts 28 at a

node or junction 44, and the upper end of the strut 31 is connected to two struts 32 at a node or node or junction 44, and the upper end of the strut 31 is connected to two struts 32 at a node or

junction 46. The strut 31 can have a thickness S Ithat is less than the thicknesses S2 of the junction 46. The strut 31 can have a thickness S1 that is less than the thicknesses S2 of the

junctions 44, junctions 44, 46. FIG. 53 46. FIG. 53 shows showsa aportion portionofofthe the frame frame1212inin aa crimped crimpedstate. state. The Thejunctions junctions44, 44, 46, along 46, with junctions along with junctions 64, 64, prevent prevent full fullclosure closureof ofopenings openings 40. 40. FIG. FIG. 18 18 shows the valve shows the valve 10 10 crimped on a balloon catheter. As can be seen, the geometry of the struts 31, and junctions 44, crimped on a balloon catheter. As can be seen, the geometry of the struts 31, and junctions 44,

46 and 64 assists in creating enough space in openings 40 in the crimped state to allow portions 46 and 64 assists in creating enough space in openings 40 in the crimped state to allow portions

of the leaflets to protrude (i.e., bulge) outwardly through openings. This allows the valve to be of the leaflets to protrude (i.e., bulge) outwardly through openings. This allows the valve to be

crimped to a relatively smaller diameter than if all of the leaflet material is constrained within crimped to a relatively smaller diameter than if all of the leaflet material is constrained within

the crimped the frame. crimped frame.

AH25(42477228_1):BJM

20 28 Jul 2023

[0077] The

[0077] preventororat configuredtotoprevent frame1212isisconfigured Theframe least minimize at least minimize possible over-expansionofof possible over-expansion the valve the valveatata apredetermined predetermined balloon balloon pressure, pressure, especially especially at the outflow at the outflow endofportion end portion of the the frame, frame, whichsupports which supports the the leaflet leaflet structure structure 14.oneInaspect, 14. In one aspect, the isframe the frame is configured configured to have to have relatively relatively larger angles larger angles42a, 42a,42b, 42b, 42c, 42c, 42d, 42d, 42e 42e between between struts. struts. Thethe The larger larger thetheangle, angle, thethegreater greater force the force required to required to open (expand) the open (expand) the frame. frame. This Thisphenomenon phenomenon is schematically is schematically illustratedininFIGS. illustrated FIGS.

2023208213 15A and 15A and15B. 15B.FIG. FIG. 15A15A shows shows a strut a strut 32 32 when when the frame the frame 12 is12inisits in its compressed compressed state state (e.g., (e.g.,

mountedonona aballoon). mounted balloon). The The verticaldistance vertical distancedldlbetween between theends the endsofof thestruts the struts is is greatest greatest when when

the frame the is compressed, frame is providingaa relatively compressed, providing relatively large large moment between moment between forcesF1Fl forces and and F2 F2 acting acting

on the on the ends endsofof thestrut the strutininopposite opposite directions directions upon upon application application of an opening of an opening force fromforce from inflation of inflation ofthe theballoon balloon(or (orexpansion expansionof ofanother anotherexpansion expansion device). device). When theframe When the frameexpands expands radially, the radially, the vertical vertical distance distancebetween between the ends the ends of theof the strut strut decreases decreases to a distance to a distance d2, as d2, as depicted in depicted in FIG. 15B. AsAsthe FIG. 15B. thevertical vertical distance distance decreases, decreases, so does does the the moment between moment between forces forces F1 F

andF2. and F2.Hence, Hence, it can it can be seen be seen that that a relatively a relatively greater greater expansion expansion force is force is required required as the as the vertical vertical distance and distance and the the moment between moment between thethe ends ends of of thethestrut strutdecreases. decreases. Moreover, Moreover, strainhardening strain hardening (stiffening) at (stiffening) at the the ends endsofofthe thestrut strutincreases increases as as thethe frame frame expands, expands, which increases which increases the the expansionforce expansion force required required to induce to induce further further plastic plastic deformation deformation at the at the ends ends of the of the strut. As strut. such, As such, the angles the anglesbetween betweenthe the struts struts of the of the frame frame can becan be selected selected to limittoradial limit expansion radial expansion of of the frame the frame at aa given at opening given opening pressure pressure (e.g., (e.g., inflation inflation pressure pressure ofballoon). of the the balloon). In particular In particular embodiments, embodiments,

these angles these anglesare areatatleast least110 110 degrees degrees or greater or greater when when theisframe the frame is expanded expanded to its functional to its functional size, size, andeven and evenmore more particularly particularly thesethese angles angles are atare at 120 least leastdegrees 120 degrees or when or greater greater whenisthe the frame frame is expanded expanded to to itsits functional functional size. size.

[0078] In addition,

[0078] In inflow and the inflow addition, the and outflow outflow ends of aa frame ends of frame generally to over-expand tend to generally tend more over-expand more

so than so thanthe themiddle middle portion portion of the of the frame frame due todue the to theboning" "dog "dog boning" effect of effect of theused the balloon balloon to used to expandthethe expand valve. valve. To protect To protect against against over-expansion over-expansion of thestructure of the leaflet leaflet structure 14, the 14, the leaflet leaflet structure desirably structure desirablyisissecured secured to the to the frame frame 12 below 12 below therow the upper upper row of of struts 32,struts 32,shown as best as best in shown in FIG. 1. FIG. 1. FIG. 55 shows FIG. 55 showsa aflattened flattened view viewofofthe the frame frame1212similar similarto to FIG. 5, but FIG.5, but showing showing a aline line 176 superimposed 176 superimposedover over the frame the frame to indicate to indicate the position the position of the of the upper upper edges edges of the of the leaflets 40.leaflets 40. Thus,ininthe Thus, theevent eventthat that thethe outflow outflow endtheofframe end of the frame is over-expanded, is over-expanded, thestructure the leaflet leaflet structure is is positionedatata alevel positioned levelbelow below where where over-expansion over-expansion is likelyisto likely occur,tothereby occur,protecting thereby protecting the the leaflet structure leaflet fromover-expansion. structure from over-expansion.

In aa known

[0079] In

[0079] valveconstruction, known valve construction, the can protrude leaflets can the leaflets protrude outwardly outwardly beyond theoutflow beyondthe outflow endofofthe end theframe frame when when the valve the valve is crimped is crimped if the leaflets if the leaflets are mounted are mounted too close too close to the to the distal end distal end of the of the frame. If the frame. If the delivery deliverycatheter catheteron onwhich which the the crimped crimped valve is is mounted includes aa pushing mounted includes pushing

AH25(42477228_1):BJM

21 Jul 2023

mechanism mechanism or or stopmember stop member thatthat pushes pushes against against or or abuts abuts thethe outflow outflow endend of of thethe valve valve (for (for

example,to tomaintain example, maintain the the position position ofcrimped of the the crimped valve onvalve on the delivery the delivery catheter), catheter), the pushingthe pushing memberororstop member stopmember membercan can damage damage the exposed the exposed leaflets leaflets thatthat extend extend beyond beyond the outflow the outflow end end of of 2023208213 28

the frame. Another the Anotherbenefit benefitofofmounting mountingthe theleaflets leaflets at at a location location spaced spaced from from the outflow outflow

end178 end 178ofof theframe the frame is that is that whenwhen the valve the valve is crimped is crimped on a delivery on a delivery catheter, catheter, as as shown in shown in FIG.56, FIG. 56,the theleaflets leaflets4040do do notnot protrude protrude beyond beyond the outflow the outflow endthe178 end 178 of of in frame thethe frame axialin the axial direction. As direction. such, if As such, if the thedelivery deliverycatheter catheterincludes includesa pushing a pushingmechanism or stop mechanism or stop member that member that

pushes against pushes against or or abuts abuts the outflow outflow end of the end of the valve, valve, the thepushing pushing mechanism mechanism ororstop stopmember member can contact can contactthe theendend 178 178 of the of the frame, frame, andleaflets and not not leaflets 40, so 40, soavoid as to as todamage avoidtodamage to the the leaflets. leaflets.

[0080] Also,

[0080] Also, as can be as can be seen in FIG. seen in FIG. 5, the openings 5, the openings 36 of the 36 of the lowermost rowofofopenings lowermost row the openingsininthe frame are relatively frame are relatively larger largerthan thanthe theopenings openings38 38 of ofthe thetwo twointermediate intermediaterows rows of of openings. As openings. As

shownininFIG. shown FIG.54, 54,this this allows allows the the frame, frame, when crimped,totoassume when crimped, assumean an overalltapered overall taperedshape shapethat that tapers from tapers a maximum from a diameter maximum diameter D1 the D1 at at the outflow outflow end end of the of the valve valve to to a minimum a minimum diameter diameter D2 D2 at the at the inflow inflow end end of of the thevalve. valve. When crimped,the When crimped, theframe frame1212has hasa areduced reduceddiameter diameter region region

extendingalong extending along a portion a portion of frame of the the frame adjacent adjacent the end the inflow inflow end of the of the frame, frame, by indicated indicated by reference number reference number174, 174,that that generally generally corresponds correspondstotothe the region region of of the the frame coveredby frame covered bythe the outer outer skirt 18. skirt 18. The The diameter of region diameter of region 174 174 is is reduced comparedtotothe reduced compared thediameter diameterofofthe theupper upperportion portion of the of the frame frame(which (which is not is not covered covered byouter by the the outer skirt) skirt) suchthethat such that theskirt outer outer18 skirt 18 does does not not increase the increase the overall overall crimp crimp profile profileof ofthe thevalve. valve.When the valve When the valve is is deployed, deployed, the the frame frame can can

expandtoto the expand the cylindrical cylindrical shape shape shown in FIG. shown in FIG.4. 4. In In one oneexample, example,the theframe frameofofa a26-mm 26-mm valve, valve,

whencrimped, when crimped,had hada adiameter diameterD1D1 of of 14 14 French French at at thethe outflow outflow endend of of thethe valve valve andand a diameter a diameter

D2ofof1212French D2 French at the at the inflow inflow end end of theof the valve. valve.

[0081] and1212show FIGS.1111and

[0081] FIGS. an an show alternativeframe alternative 50 50 frame that incorporatedininthe canbebeincorporated thatcan valve10. thevalve 10. The frame The frame5050comprises comprisesmultiple multiplerows rows of of circumferentiallyextending, circumferentially extending,angled angled struts5252that struts thatare are connected toto each connected each other other at at nodes, or connecting nodes, or portions, 54 connecting portions, 54 and 56. The and 56. Theuppermost uppermost row row of of struts 52 struts are connected 52 are connectedto to an adjacent an adjacent row row of of struts struts by a plurality by a plurality of axially of axially extending extending struts 58 struts 58 and commissure and commissurewindow window frame frame portions portions 60. 60. Each Each commissure commissure frame portion frame portion 60 defines 60 defines a slot,a slot, or commissure or window, commissure window, 62 62 forfor mounting mounting a respective a respective commissure commissure ofvalvular of the the valvular structure, structure, as as describediningreater described greaterdetail detail below. below. In particular In particular embodiments, embodiments, the thickness the thickness T of50the T of the frame is frame 50 is about 0.45 about 0.45 mm mmororless. less. FIGS. FIGS.1313andand 14 14 areare enlarged enlarged views views of of thethe portionsofofthe portions theframe frame5050 identified by identified byletters letters AAandand B, B, respectively, respectively, in FIG. in FIG. 12. 12.

AH25(42477228_1):BJM

22 28 Jul 2023

[0082] The

[0082]The main main functions of theof functions the inner inner skirt skirt 16 to are are 16 to assist assist in securing in securing the valvular structure structure the valvular 14 14 to the to the frame frame 12 and to assist and to assistininforming formingaagood good seal sealbetween between the the valve valve and and the the native native annulus annulus by by

blocking the blocking the flow flow of of blood throughthe blood through the open opencells cells of of the the frame 12 below frame 12 belowthe the lower loweredge edgeofofthe the leaflets. The leaflets. Theinner inner skirt16 16 skirt desirably desirably comprises comprises a tough, a tough, tear resistant tear resistant materialmaterial such as such as polyethylene polyethylene terephthalate terephthalate (PET), (PET), although although various various other synthetic other synthetic or naturalor natural can materials materials be can be

2023208213 used. The used. The thickness thickness of the of the skirtskirt desirably desirably is than is less less than 6 mil,6 and mil,desirably and desirably less less than thanand 4 mil, 4 mil, and even more even moredesirably desirablyabout about2 2mil. mil. InInparticular particular embodiments, embodiments,thetheskirt skirt16 16 can canhave havea avariable variable thickness,for thickness, forexample, example,the the skirt skirt can can be thicker be thicker atedges at its its edges than than at its at its center. center. In one In one implementation, the skirt implementation, the skirt 16 16 can can comprise comprise aa PET PETskirt skirt having havingaathickness thickness of of about about 0.07 0.07 mm mm at at

its its edges andabout edges and about 0.06 0.06 mm mm at itsatcenter. its center. The thinner The thinner skirt skirt can can for provide provide betterfor better crimping crimping

performanceswhile performances whilestill still providing goodperivalvular providing good perivalvular sealing. sealing.

The

[0083]The

[0083] skirt skirt cancan 16 16 be secured the inside to thetoinside be secured of12 of frame frame via sutures sutures 12 via 70, 70, in as shown as FIG. shown 39. in FIG. 39. Valvularstructure Valvular structure 14 14 cancan be attached be attached to thetoskirt the skirt viaorone via one moreorthin morePETthin PET reinforcing reinforcing strips 72 strips 72 (which collectively can (which collectively can form form aa sleeve), sleeve), discussed discussed below, whichenables below, which enablesaa secure secure suturing suturing and and protects the protects thepericardial pericardialtissue tissue of of thethe leaflet leaflet structure structure from from tears. tears. Valvular Valvular structure structure 14 14 can be can be sandwiched between sandwiched between skirt1616and skirt andthe thethin thinPET PET strips7272asasshown strips shownin in FIG. FIG. 38.Sutures 38. Sutures 154, 154,

whichsecure which secure thethe PETPET stripstrip andleaflet and the the leaflet structure structure 14 to 16, 14 to skirt skirt can16, be can be any suitable any suitable suture, suture, such as such as an an Ethibond suture. Sutures Ethibond suture. Sutures154 154desirably desirablytrack track the the curvature curvature of of the the bottom edge of bottom edge of leaflet structure leaflet 14, asasdescribed structure 14, describedin in more more detail detail below. below.

Known

[0084] Known

[0084] fabric comprisea aweave skirtscomprise fabricskirts of of weave warp andand warp weft weft fibers fibers thatextend that extend perpendicular perpendicular

to each to each other other and and with with one set of one set of fibers fibersextending extendingperpendicularly perpendicularly to tothe theupper upperand and lower lower edges edges

of the of the skirt. skirt. When Whenthe the metal metal frame, frame, to which to which the skirt the fabric fabricisskirt secured, is radially is secured, is compressed, radially compressed, the overall the overall axial axiallength lengthof of the the frame frame increases. increases. Unfortunately, Unfortunately, a fabrica skirt, fabricwhich skirt,inherently which inherently has limited has limitedelasticity, elasticity,cannot cannot elongate elongate along along withframe with the the and frame and therefore therefore tends to tends to deform thedeform the struts of struts ofthe theframe frameand and prevents prevents uniform crimping. uniform crimping.

[0085] showsananexample FIG. 1717 shows

[0085] FIG. of of example a crimped a crimped valve valve where where the the struts struts have have been been deformed deformed in in several places, several places,asasindicated indicatedby by reference reference number number 100, by 100, by having a skirt a skirtfibers having fibers that that extend extend perpendicular to perpendicular to the upper and lower upper and lower edges edges of ofthe the skirt. skirt. Moreover, the fabric Moreover, the fabric tends tends to to bunch bunch or

create bulges create bulges of of excess excess material material in incertain certainlocations, which locations, whichlimits thethe limits minimum minimum crimping profile crimping profile

and prevents and prevents uniform uniformcrimping. crimping.

AH25(42477228_1):BJM

23 Jul 2023

Referring

[0086]Referring

[0086] 16B, 16B, to FIG. to FIG. in contrast in contrast to known to known fabric skirts, skirtthe skirts, fabric the 16 skirt 16 desirably desirably is woven is woven froma afirst from first set set of offibers, fibers, or or yarns yamsororstrands, strands,78 78 andand a second a second set ofset offibers, fibers, or yarns or yarns or strands, or strands, 80, both 80, bothofofwhich whichareare non-perpendicular non-perpendicular to the to theedge upper upper edgethe82lower 82 and and edge the lower edge 84 of the 84 skirt. of the skirt. 2023208213 28

In particular In particular embodiments, embodiments, the first the first setfibers set of of fibers 78 the 78 and andsecond the second set of80 set of fibers fibers 80atextend extend at angles of about 45 angles of degrees relative 45 degrees relative to tothe theupper upperand and lower lower edges 82, 84. edges 82, 84. The skirt 16 The skirt 16 can be

formedby formed byweaving weaving thefibers the 45 degree fibersatat 45 degreeangles anglesrelative relative to to the the upper upper and lower edges and lower edges of of the the fabric. Alternatively,thethe fabric. Alternatively, skirt skirt cancan be be diagonally diagonally cut afrom cut from a vertically vertically woven woven fabric fabric (where the(where the

fibers extendperpendicular fibers extend perpendicular to the to the edges edges of theof the material) material) such such that thethat theextend fibers fibersatextend at 45 degree 45 degree

anglesrelative angles relativetotothe thecut cutupper upper andand lower lower edgesedges of the of the skirt. skirt. As further As further shown in shown in the FIG. 16B, FIG. 16B, the opposingshort opposing short edges edges 86,of88theofskirt 86, 88 the skirt desirably desirably are non-perpendicular are non-perpendicular to the to the upper upper and lower and lower edges 82, edges 82, 84. 84. For For example, example,the theshort shortedges edges86, 86, 88 88 desirably desirably extend extendatat angles angles of of about about 45 45 degreesrelative degrees relativetotothetheupper upper and and lower lower edges edges and therefore and therefore are with are aligned aligned with set the first the offirst set fibers offibers 78. Therefore 78. Thereforethethe overall overall shape shape of theofskirt the skirt is that is that of a of a rhomboid. rhomboid.

[0087] FIGS.

[0087] 19A FIGS.19A 19B19B and and shows the the shows skirt 16 16 skirt after after opposing opposing edge edge portions 90,90, portions 92 92 have have been been

sewntogether sewn together to to form formthe the annular annular shape shape of ofthe the skirt. skirt. As As shown, the edge shown, the edge portion portion 90 90 can canbe be placedininananoverlapping placed overlapping relationship relationship relative relative to thetoopposite the opposite edge 92, edge portion portion 92,two and the andedge the two edge portionscan portions canbebe sewn sewn together together with with a diagonally a diagonally extending extending suture suture line line 94 that is 94 that istoparallel parallel to edges 86, edges 86, 88. 88. The Theupper upperedge edgeportion portionofofthe theskirt skirt 16 16 can can be be formed formedwith witha aplurality plurality of of

projections9696that projections thatdefine define an undulated an undulated shape shape that generally that generally follows follows the shape the shape of the of the fourth row fourth row of struts of struts 28 28 immediately immediately adjacent adjacent the lower the lower ends ofends axialofstruts axial 31. struts 31. manner, In this In this as manner, best as best shownin in shown FIG. FIG. 20, 20, the the upper upper edge edge of 16 of skirt skirt can 16 be can be tightly tightly secured secured to struts to 28 struts 28 with with sutures 70.sutures 70. Skirt 16 Skirt 16can canalso alsobebe formed formed with with slits slits 98 to98 to facilitate facilitate attachment attachment of the of thetoskirt skirt the to the Slits frame. frame. Slits 98 are 98 are dimensioned dimensioned sosoasasto to allow allow an an upper upperedge edgeportion portionofofskirt skirt to to be be partially partiallywrapped wrapped around around

struts 28 struts andreduce 28 and reduce stresses stresses in the in the skirt skirt during during the attachment the attachment procedure. procedure. Forinexample, For example, the in the illustrated embodiment, illustrated embodiment, skirt skirt 16placed 16 is is placed oninside on the the inside of 12 of frame frame 12upper and an and edge an upper edge portion of portion of the skirt the skirt is is wrapped around wrapped around the the upper upper surfaces surfaces of struts of struts 28 and 28 and secured secured in place in place with with sutures 70.sutures 70. Wrapping Wrapping the the upper upper edge edge portion portion of the of thearound skirt skirt around struts 28struts 28manner in this in thisprovides mannerforprovides a for a strongerand stronger andmore more durable durable attachment attachment of thetoskirt of the skirt to the The the frame. frame. skirt The skirt 16 can also16becan also secured be secured to the to the first, first, second, andthird second, and thirdrows rows of of struts struts 22,22, 24, 24, and and 26, respectively, 26, respectively, with sutures with sutures 70. 70.

[0088]Referring

[0088] Referring again again to FIG. to FIG. 16B, 16B, due to due to the orientation the orientation of the fibers fibers relative of therelative to the to the upper and upper and loweredges, lower edges,thethe skirt skirt cancan undergo undergo greater greater elongation elongation in thedirection in the axial axial direction (i.e., in(i.e., in a direction a direction

from the from the upper upper edge edge8282toto the the lower lower edge edge84). 84).

AH25(42477228_1):BJM

24 2023208213 28 Jul 2023

[0089] Thus,

[0089] themetal whenthe Thus, when frame metalframe is iscrimped 12 12 (as(as crimped shown in in shown FIG. FIG. 18), thethe 18), skirt can skirt1616can elongate in elongate in the the axial axialdirection directionalong alongwith withthe theframe frameand and therefore thereforeprovides providesaamore more uniform and uniform and

predictable crimping predictable profile. Each crimping profile. Each cell cell of the the metal metal frame in the frame in the illustrated illustratedembodiment embodiment

includesatatleast includes leastfour fourangled angled struts struts that that rotate rotate towards towards the axial the axial direction direction (i.e., (i.e., the angled the angled struts struts

becomemore become more aligned aligned with with thethe length length ofof theframe). the frame).The The angled angled strutsofofeach struts eachcell cellfunction function as as aa mechanism mechanism for for rotating rotating the fibers the fibers ofskirt of the the skirt insame in the the direction same direction of the struts, of the struts, allowingallowing the the skirt to skirt to elongate along elongate along thethe length length of the of the struts. struts. This This allows allows for greater for greater elongation elongation of the of the skirt andskirt and avoids undesirable avoids undesirable deformation deformationofofthe the struts struts when the valve when the valve is is crimped. crimped.

[0090] addition,thethe

[0090]InInaddition, spacing spacing between between the woven wovenorfibers the fibers or yarns yarns can be increased facilitateto can betoincreased facilitate elongationofof elongation theskirt the skirtininthetheaxial axial direction. direction. For For example, example, for skirt for a PET a PET16 skirt formed16from formed from 20-denier yarn, 20-denier yarn, the the yam yarn density density can can be be about 15%toto about about 15% about 30% 30% lessthan less thana aconventional conventionalPET PET skirt. In skirt. Insome examples, the some examples, the yarn yarn spacing spacing of of the the skirt skirt 16 16 can can be be from from about 155 yarns about 155 yarns per per inch inch to about to 180 yarns about 180 yams per per inch, inch, such such about 160 160 yarns yarns per per inch, inch, whereas in aa conventional whereas in PETskirt conventional PET skirt the yam the yarn spacing can can be be from from about about217 217yarns yamsper perinch inchtoto about about 247 247yarns yarnsper perinch. inch. The The oblique oblique

edges 86, edges 86, 88 88 promote promoteuniform uniformandand even even distributionofofthe distribution thefabric fabric material material along along inner inner circumference circumference of the of the frame frame during during crimping crimping so as toso as to minimize minimize bunching ofbunching the fabric of to the fabric facilitate to facilitate uniformcrimping uniform crimping to the to the smallest smallest possible possible diameter. diameter. Additionally, Additionally, cuttingsutures cutting diagonal diagonal in a sutures in a vertical manner vertical mayleave manner may leaveloose loosefringes fringes along alongthe the cut cut edges. edges. The Theoblique obliqueedges edges86, 86,8888help help minimizethis minimize this from fromoccurring. occurring. AsAsnoted notedabove, above,FIG. FIG. 17 17 shows shows a crimped a crimped valve valve with with a a conventionalskirt conventional skirt that that hashas fibers fibers that that run run perpendicular perpendicular to the to the upper upper andedges and lower lower edges of the of skirt. the skirt. Comparing Comparing FIGS. FIGS. 17 and1718, and 18,apparent it is it is apparent that thethat the construction construction of avoids of skirt 16 skirt 16 avoids undesirable undesirable

deformation ofofthe deformation the frame frame struts struts and and provides moreuniform provides more uniformcrimping crimping of of thetheframe. frame.

[0091] In

[0091] alternative embodiments, In alternative embodiments, the can be skirt can the skirt be formed formed from woven fromwoven elasticfibers elastic that can fibersthat can stretch in stretch in the the axial axial direction directionduring during crimping crimping ofvalve. of the the valve. The The warp andwarp and weft weft fibers can fibers run can run perpendicular perpendicular andand parallel parallel to the to the upper upper and lower and lower edges ofedges of theorskirt, the skirt, or alternatively, alternatively, they can they can extendatatangles extend anglesbetween between 0 and0 90 and 90 degrees degrees relativerelative to theandupper to the upper lower and lower edges edges of the skirt,of asthe skirt, as described above. described above.

The

[0092]The

[0092] inner inner skirt skirt 16 can 16 can be sutured to theto be sutured the frame frame 12 at locations away fromaway 12 at locations the suture the fromline suture line 154 sothat 154 so thatthe theskirt skirtcan canbebemore more pliable pliable in that in that area area (see (see FIG. FIG. 28).canThis 28). This can avoid avoid stress stress

concentrationsat at concentrations thethe suture suture lineline 154,154, which which attaches attaches the edges the lower lowerofedges of the to the leaflets leaflets to the the skirt skirt 16. 16.

AH25(42477228_1):BJM

25 Jul 2023

[0093]AsAs

[0093] noted noted above, above, the leaflet the leaflet structure 14 in 14 structure the in the illustrated illustrated embodiment embodiment includes includes three three flexible leaflets flexible leaflets 40 40(although (although a greater a greater or fewer or fewer number number of leaflets of leaflets can beAsused). can be used). As best best shown shown in FIG. in FIG.21, 21,each eachleaflet leaflet40 40 in in thethe illustrated illustrated configuration configuration has has an an upper upper (outflow) (outflow) free edgefree 110 edge 110 2023208213 28

extending between extending betweenopposing opposing upper upper tabs tabs 112112 on on opposite opposite sides sides of of thethe leaflet. Below leaflet. Below each each upper upper

tab 112 tab 112 there there is is aanotch notch 114 114 separating separating the theupper upper tab tabfrom from aa corresponding lower tab corresponding lower tab 116. 116. The The lower (inflow) lower (inflow) edge edge portion portion 108 108 of of the the leaflet leaflet extending extending between respective ends between respective ends of of the lower lower

tabs 116 tabs 116includes includes vertical, vertical, or or axial, axial, edge edge portions portions 118 on118 on opposites opposites of the leaflets of the leaflets extendingextending

downwardly downwardly from from corresponding corresponding lower lower tabstabs 116 116 and and a a substantially substantially V-shaped, V-shaped, intermediate intermediate edge edge

portion120 portion 120having having a smooth, a smooth, curvedcurved apex portion apex portion 119 at the119 at the lower lower end of end of and the leaflet the aleaflet pair and a pair of oblique of oblique portions 121 121 that that extend extend between the axial between the axial edge edge portions portions and and the the apex apex portion. portion. The The obliqueportions oblique portionscancan have have a greater a greater radius radius of curvature of curvature than than the apexthe apex portion. portion. Each Each leaflet 40 leaflet 40 can have can havea areinforcing reinforcing strip strip 72 72 secured secured (e.g., (e.g., sewn)sewn) to the to the surface inner inner surface of theedge of the lower lower edge portion portion 108, 108, as as shown in FIG. shown in FIG. 22. 22.

[0094] The

[0094] leaflets 40 Theleaflets can be 40 can be secured to one secured to another at one another theiradjacent at their sidestoto adjacentsides formcommissures form commissures

122 ofofthe 122 theleaflet leafletstructure. structure.A A plurality plurality of flexible of flexible connectors connectors 124of(one 124 (one whichof iswhich is shown in shown in FIG.23) FIG. 23)cancan be be used used to interconnect to interconnect pairs pairs of adjacent of adjacent sides ofsides of the leaflets the leaflets and to and to mount themount the leaflets totothe leaflets thecommissure commissure window frame window frame portions30.30.TheThe portions flexible flexible connectors connectors 124124 cancan be be made made

from aa piece from piece of of woven PET woven PET fabric,although fabric, althoughother othersynthetic syntheticand/or and/ornatural natural materials materials can can be be used. used. Each flexible Each flexible connector connector 124 124 can caninclude includeaa wedge wedge126126 extending extending from from thethe lower lower edgeedge to the to the

upper edge upper edgeat at the the center center of of the theconnector. connector. The wedge126 The wedge 126can cancomprise comprise a non-metallic a non-metallic material, material,

suchasasaarope such ropeorora piece a piece of of Ethibond Ethibond 2-0 suture 2-0 suture material, material, securedsecured to the connector to the connector with a with a temporarysuture temporary suture128. 128. The Thewedge wedge 126 126 helps helps prevent prevent rotational rotational movement movement ofleaflet of the the leaflet tabstabs once they once they are are secured to the secured to the commissure window commissure window frame frame portions portions 30. 30. The The connector connector 124 124 can can have aa series have series of of inner innernotches notches 130 130 and and outer outer notches notches 132 formedalong 132 formed alongits its upper upper and and lower lower edges. edges.

[0095]FIG.

[0095] FIG.24 24 shows shows the adjacent the adjacent sides of two of sides two leaflets leaflets 40 interconnected 40 interconnected by by a flexible a flexible connector 124. connector 124. The Theopposite oppositeend end portionsofofthe portions theflexible flexible connector connector124 124can canbebeplaced placedininanan overlapping relationship overlapping relationship with with the the lower tabs 116 lower tabs 116 with with the the inner notches 130 aligned notches 130 aligned with with the the vertical edges vertical edges of of the thetabs tabs116. 116. Each Each tab tab 116 116 can be secured to aa corresponding secured to end portion corresponding end portion of of the flexible the flexible connector connector 124 124 by suturing along aa line by suturing line extending extending from an outer from an outer notch 132 on notch 132 on the the lower edge lower edge to to an an outer outer notch 132 on notch 132 on the the upper upper edge edgeofofthe the connector. connector. Three Threeleaflets leaflets 40 40 can canbe be securedtotoeach secured each other other side-to-side side-to-side using using threethree flexible flexible connectors connectors 124, as 124, as shown in shown FIG. 25.in FIG. 25.

AH25(42477228_1):BJM

26 Jul 2023

[0096] FIGS.2626 nowtotoFIGS. Referring now

[0096] Referring and and 27,thetheadjacent 27, sub-commissure adjacentsub-commissure portions 118 118 portions of of two two leaflets can leaflets canbe be sutured sutureddirectly directlytoto each other. each InIn other. thethe example exampleshown, shown, PTFE-6-0 suture material PTFE-6-0 suture material is used is used to to form form in-and-out in-and-out stitches stitches133 133 and and comb stitches 134 that comb stitches that extend extend through the through the

2023208213 28

sub-commissureportions sub-commissure portions118118 andand thethe reinforcingstrips reinforcing strips7272ononboth bothleaflets. leaflets. The Thetwo tworemaining remaining pairs of pairs of adjacent adjacent sub-commissure portions118 sub-commissure portions 118can canbebesutured suturedtogether togetherininthe the same samemanner mannerto to formthe form theassembled assembled leaflet leaflet structure structure 14, which 14, which can can then be then be to secured secured to the the frame frame 12 in the 12 in the following manner. following manner.

[0097]AsAs

[0097] noted noted above, above, the inner usedbe 16 can16becan skirt skirt the inner toused to inassist assist in suturing suturing the leaflet leaflet structure thestructure 14 14 to the to the frame. As shown frame. As shownininFIG. FIG.28, 28,the theskirt skirt 16 16 can can have have an an undulating undulating temporary temporarymarking marking suture 136 suture 136totoguide guide thethe attachment attachment of theoflower the lower edges edges of each of each40. leaflet leaflet 40. The The skirt skirtcan 16 itself 16 itself can be sutured be suturedtotothe thestruts strutsofofthetheframe frame 12 using 12 using sutures sutures 70, as70, as noted noted above,securing above, before before the securing the leaflet structure leaflet 14totothe structure 14 theskirt skirt16. 16.TheThe struts struts thatthat intersect intersect the the marking marking suturesuture 136 desirably 136 desirably are are not attached not attachedtotothetheskirt skirt16.16.ThisThis allows allows the skirt the skirt 16 to16 be to be pliable more more pliable in thenotareas in the areas not secured secured to the to the frame frameand and minimizes minimizes stressstress concentrations concentrations along along the theline suture suture that line thatthe secures secures lower the lower edgesofofthe edges theleaflets leafletstotothe theskirt. skirt.TheThe portion portion of skirt of the the skirt 16 demarcated 16 demarcated by rectangle by rectangle 140 140 initially is initially is left leftunsecured tothe unsecured to theframe frame12,12, andand is later is later secured secured to frame to the the frame afterleaflet after the the leaflet structure 1414isissecured structure securedto to thethe skirt,asasfurther skirt, further described described below. below. Asabove, As noted notedwhen above, whenisthe the skirt skirt is securedtotothe secured theframe, frame, thethe fibers fibers 78, 78, 80the 80 of of skirt the skirt (see (see FIG. FIG. 16B) generally 16B) generally align align with the with angledthe angled struts of struts ofthe theframe frametotopromote promote uniform crimping and uniform crimping andexpansion expansionofofthe theframe. frame.

[0098]FIG.

[0098] FIG. 29 29 is ais cross-sectional a cross-sectional view view of a portion of a portion of the of theand frame frame andstructure leaflet leaflet structure showing showing the adjacent the adjacent tab tab portions portions of oftwo two leaflets leafletssecured securedtoto a corresponding a correspondingwindow frame portion window frame portion 30. 30. FIGS. 30-36 FIGS. 30-36show show one one specificapproach specific approach forfor securing securing thethe commissure commissure portions portions 122 122 of the of the leaflet leaflet

structure 14 structure 14 to tothe thecommissure window commissure window frame frame portions portions 30 30 of of thethe frame.First, frame. First,asasshown shownin in FIG. FIG.

30, the 30, the flexible flexibleconnector connector124 124 securing securing two adjacent two adjacent sides ofsides of two is two leaflets leaflets folded iswidthwise folded widthwise and the and the upper tab portions 112 are upper tab are folded downwardly againstthe downwardly against theflexible flexible connector. connector. AsAsbest best shownininFIGS. shown FIGS.3030and and31, 31,each eachupper upper tabportion tab portion112112isiscreased creasedlengthwise lengthwise(vertically) (vertically) to to assumean an assume L-shape L-shape having having an portion an inner inner portion 142against 142 folded foldedtheagainst the inner inner surface surface of the of leaflet the leaflet and an and an outer outer portion 144 144 folded folded against against the the connector 124. The connector 124. Theouter outerportion portion144 144can canthen thenbebe sutured to sutured to the the connector 124 along connector 124 along aa suture suture line line 146. 146. Next, as as shown in FIG. shown in FIG. 31, 31, the the commissuretab commissure tabassembly assembly (comprised (comprised of aofpair a pair of of lower lower tabtab portions116116 portions connected connected by by connector connector

124) is is inserted insertedthrough through the thecommissure window commissure window 20 20 of of a corresponding a corresponding window window frameframe portion portion

30. FIG. 30. FIG. 32 32is is aa side side view of the view of the frame 12 showing frame 12 thecommissure showing the commissuretabtab assembly assembly extending extending

outwardly through outwardly throughthe thewindow window frame frame portion portion 30.30.

AH25(42477228_1):BJM

27 Jul 2023

[0099] As

[0099] Asbest best shown shownininFIG. FIG.2929and and33,33,the thecommissure commissuretab tab assembly assembly is pressed is pressed radially radially

inwardly at inwardly at the wedge 126such wedge 126 suchthat thatone oneofofthe the lower lowertab tab portions portions 116 116 and andaa portion portion of of the the connector 124 connector 124isis folded folded against against the frame 12 on frame 12 on one one side side of of the the window frameportion window frame portion3030and and 2023208213 28

the other the otherlower lowertabtab portion portion 116 116 and aand a portion portion of theof the connector connector 124 isagainst 124 is folded foldedtheagainst the frame 12 frame 12 on other on otherside sideofofthe thewindow window frameframe portion portion 30. ofAsuture 30. A pair pair of suture lines 148 lines 148 to are formed areretain formedthe to retain the lower tab lower tab portions portions 116 against the 116 against the frame 12 in frame 12 in the the manner shownininFIG. manner shown FIG.29. 29.Each Each suture suture line line

148 extends through 148 extends throughconnector connector124, 124,a alower lowertab tabportion portion116, 116,the the wedge wedge126, 126,andand another another portion portion

of connector of 124. Then, connector 124. Then,asasshown shownin in FIGS. FIGS. 29 29 andand 34,34, each each lower lower tabtab portion portion 116116 is is secured secured to to

a corresponding a uppertab corresponding upper tab portion portion 112 112with withaaprimary primarysuture sutureline line 150 150that that extends extends through through one one layer of layer ofconnector connector 124, 124, the the lower lower tab portion tab portion 116, another 116, another layer oflayer of connector connector 124, 124, another another layer layer of connector of 124, and connector 124, and the the upper upper tab tab portion portion 112. 112. Finally, Finally, as as shown in FIGS. shown in FIGS.2929and and35, 35,the the suture material material used used to to form form the the primary suture line primary suture line 150 150 can can be be used used to to further furtherform form whip whip

stitches 152 stitches 152atatthe theedges edgesof of thethe tabtab portions portions 112, 112, 116 extend 116 that that extend through through two two layers of layers of connector 124 connector 124sandwiched sandwiched between between tab tab portions portions 112, 112, 116. 116.

[00100]

[00100] As FIGS.2929 shownininFIGS. As shown and and 30,30, thethefolded down foldeddown upper tab tab upper portions 112112 portions form form a a doublelayer double layerofof leafletmaterial leaflet material at the at the commissures. commissures. Theportions The inner inner portions 142 of the 142 oftab upper the upper tab portions112 portions 112 areare positioned positioned flatflat abutting abutting layers layers oftwo of the theleaflets two leaflets 40 forming the commissures, 40 forming the commissures, such that such that each each commissure comprises commissure comprises four four layersofofleaflet layers leaflet material material just just inside insideof ofthe thewindow window

frames 30. frames 30. This Thisfour four layered layered portion portion of of the the commissures canbebemore commissures can more resistanttotobending, resistant bending,oror articulating, than articulating, thanthe theportion portionof of thethe leaflets leaflets 40 40 just just radially radially inward inward from from the relatively the relatively more more rigid rigid four layeredportion. four layered portion.ThisThis causes causes the leaflets the leaflets 40 to 40 to articulate articulate primarily primarily at inneratedges inner143edges of the143 of the

folded-down innerportions folded-down inner portions142 142ininresponse responsetotoblood bloodflowing flowingthrough through thevalve the valveduring duringoperation operation withinthe within thebody, body,as as opposed opposed to articulating to articulating about about the struts the axial axial struts of the of the frames window window 30. frames 30. Becausethethe Because leaflets leaflets articulate articulate at at a location a location spaced spaced radially radially inwardly inwardly from thefrom theframes window window 30, frames 30, the leaflets the leafletscan canavoid avoidcontact contactwith withand anddamage fromthe damage from the frame. frame. However, However, under under high high forces, forces, thethe

four layered portion four portion of of the the commissures cansplay commissures can splay apart apart about about aa longitudinal longitudinal axis axis 145 (FIG. (FIG. 29) 29) adjacent to adjacent to the the window frame30, window frame 30,with witheach eachinner innerportion portion142 142folding foldingout outagainst againstthe the respective respective outer portion outer portion 144. For For example, example,this this can can occur occur when whenthe thevalve valve1010isiscompressed compressedandand mounted mounted

onto aadelivery onto deliveryshaft, shaft,allowing allowing for for a smaller a smaller crimped crimped diameter. diameter. The four The four layered layered portion portion of the of the commissurescan commissures canalso alsosplay splayapart apartabout aboutaxis axis145 145when whenthethe balloon balloon catheterisisinflated catheter inflated during during expansion of expansion ofthe the valve, valve, which can relieve which can relieve some someofofthe the pressure pressure on on the the commissures commissurescaused caused by by

the balloon and the so the and so the commissures arenot commissures are notdamaged damaged during during expansion. expansion.

AH25(42477228_1):BJM

28 Jul 2023

[0100] After all

[0100] After threecommissure all three tab assemblies commissure tab assembliesare to respective securedto are secured respective window frame windowframe portions 30, portions 30, the the lower lower edges of of the the leaflets leaflets4040between between the the commissure tab assemblies commissure tab assembliescan canbebe sutured to sutured to the the inner innerskirt skirt16.16.For Forexample, example, as as shown in FIGS. shown in 36-38, each FIGS. 36-38, each leaflet leaflet 40 40 can can be be

2023208213 28

suturedtotothe sutured theskirt skirt1616along along suture suture lineline 154 154 using, using, for example, for example, Ethibond Ethibond thread. thread. The suturesThe sutures can be can bein-and-out in-and-out sutures sutures extending extending through through each 40, each leaflet leaflet the 40, the skirt 16 skirt 16 and and each each reinforcing reinforcing

strip 72. strip Eachleaflet 72. Each leaflet4040 andand respective respective reinforcing reinforcing strip strip 72 can72 be can sewn be sewn separately separately to to the skirt the skirt 16. InInthis 16. this manner, manner,thethe lower lower edgesedges of theof the leaflets leaflets are secured are secured to the12frame to the frame via the12skirt via the 16. skirt 16. Asshown As shown in FIG. in FIG. 38, leaflets 38, the the leaflets can can be be further further secured secured to thewith to the skirt skirt with sutures blanket blanket156 sutures that 156 that extendthrough extend through each each reinforcing reinforcing strip strip 72, leaflet 72, leaflet 40 and40 and the the 16skirt skirt 16looping while while around looping thearound the edges of edges of the reinforcing reinforcing strips strips72 72and andleaflets leaflets40.40.The Thesutures sutures156 156can canbe beformed formed from PTFE from PTFE

suture material. suture material.FIGS. FIGS. 39 40 39 and and 40 the show show the12,frame frame 12,structure leaflet leaflet structure 14 and the 14 and16the skirt skirt after 16 after securing theleaflet securing the leafletstructure structureandand the the skirt skirt to the to the frame frame andleaflet and the the leaflet structure structure to the to the skirt. skirt.

41 41 FIG.

[0101]FIG.

[0101] shows shows a flattened a flattened view of the of view theskirt outer prior18 outer18skirt toprior to its attachment its attachment to the to the frame 12. The frame 12. Theouter outerskirt skirt 18 18 can can be be laser laser cut cut or or otherwise otherwise formed fromaa strong, formed from strong, durable durable piece of material, of material, such such as aswoven PET,although woven PET, althoughother othersynthetic syntheticoror natural natural materials materials can be used. used. The The outer skirt outer skirt 18 18can canhave have a substantially a substantially straight straight lowerlower edge edge 160 and160 and an an upper upper edge edge 162 162 defining a defining a plurality of plurality ofalternating alternatingprojections projections164 164and andnotches notches166. 166. As As best best shown in FIG. shown in FIG. 42, 42, the the lower lower edge160 edge 160of of thethe skirt skirt 18 18 cancan be sutured be sutured tolower to the the lower edge ofedge of theskirt the inner inner 16 skirt at the16 at theendinflow inflow end of the of the valve. valve. As shownininFIG. As shown FIG.43, 43,each eachprojection projection164 164can canbebesutured suturedtotothe the second secondrung rungIIIIof of struts 24 struts ofthe 24 of the frame frame12.12. The The comers corners 162 of162 the of the projections projections 164folded 164 can be can be overfolded over respective respective struts of struts rungIIII and of rung andsecured secured with with sutures sutures 168. 168.

[0102]AsAs

[0102] cancan be seen be seen in FIGS. in FIGS. 1, 343,and 1, 3 and the43, outer outer18skirt theskirt 18 is secured is secured to the to the frame frame 12 such 12 such that when that whenthetheframe frame is its is in in its expanded expanded state, state, therethere is excess is excess material material or slackorbetween slack between the outer the outer skirt's lower skirt's andupper lower and upper edges edges 160, 160, 162does 162 that thatnot does lienot flatlie flat against against thesurface the outer outer of surface the of the frame 12.In In frame 12. other other words, words, the outer the outer skirt skirt is configured is configured with material with excess excess material which which causes the causes the

outer skirt outer skirt to to bulge bulgeoutwardly outwardly as the as the frame frame foreshortens foreshortens (i.e., shortens (i.e., shortens in length) in length) during during radial radial expansion. Accordingly, expansion. Accordingly, when when the the valve valve 10 deployed 10 is is deployed within within the the body, body, the the excess excess material material of of the outer the outerskirt skirt1818can canfill filliningaps gapsbetween between the frame the frame 12 and 12 theand the surrounding surrounding native native annulus to annulus to assist in assist forminga agood in forming good fluid-tight fluid-tight sealseal between between the and the valve valve the and theannulus. native native annulus. The outer The outer skirt 18 skirt 18 therefore thereforecooperates cooperateswithwith the inner the inner skirtskirt 16 to16 to avoid avoid perivalvular perivalvular leakage leakage after after implantation of implantation of the the valve 10. In valve 10. In another advantageousfeature, another advantageous feature, the the slack slack between the lower between the lower and and upperedges upper edgesof of thethe outer outer skirt skirt 18 allows 18 allows the frame the frame 12 to elongate 12 to elongate axiallycrimping axially during during crimping

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withoutany without any resistance resistance fromfrom the outer the outer skirt skirt andouter and the the skirt outer does skirtnot does not substantially substantially affect theaffect the outer diameter outer diameterof of thethe prosthetic prosthetic valve valve in crimped in the the crimped condition. condition.

[0103] 56 shows FIG. 56

[0103] FIG. thevalve showsthe FIGS.1-31-3andand valve1010ofofFIGS. 42-43 42-43 mounted mounted on an shaftshaft an elongated onelongated 180 180 of aa delivery of deliveryapparatus, apparatus, forming forming a delivery a delivery assembly assembly for implanting for implanting theinvalve the valve 10 10 in a patient's a patient's

2023208213 body. The body. Thevalve valve1010isismounted mountedin in a a radially collapsed radially collapsedconfiguration configurationfor for delivery delivery into into the body. body.

The shaft The shaft 180 180 comprises comprisesananinflatable inflatable balloon balloon 182 182 for for expanding expandingthe theballoon balloonwithin withinthe thebody, body, the crimped the valve 10 crimped valve 10 being beingpositioned positionedover overthe the deflated deflated balloon. balloon. The Theframe frame1212ofofthe thevalve valve10, 10, wheninin the when the radially radially compressed, mountedconfiguration, compressed, mounted configuration,comprises comprises an an inflow inflow endend portion portion 174174

(see FIG. (see 54)that FIG.54) thathashas an an outer outer diameter diameter D2isthat D2 that is smaller smaller than than the thediameter outer outer diameter D1 of the D1 of the outflowendend outflow portion portion of the of the frame. frame. The tapering The tapering of thecanframe of the frame be at can bepartially least at least due partially to the due to the V-shaped V-shaped leaflets leaflets 40,40, as the as the V-shaped V-shaped leaflets leaflets haveleaflet have less less leaflet material material within within the the inflow endinflow end portion of portion of the the frame 12 compared frame 12 comparedtotoaamore morerounded, rounded,U-shaped U-shaped leaflet.DueDue leaflet. to to thethe tapered tapered shape shape

of the of the frame frame1212 in in thethe mounted mounted state,state, even even with with the the additional additional thickness thickness of the of the outer outer skirt 18 skirt 18 positioned around positioned around the the inflow inflow end endportion portion 174 174ofofthe the frame frame 1212the the overall overall outer outer diameter diameter of of the the inflow endportion inflow end portion of the of the valve valve 10 becan 10 can be about about equal equal to, to, or or less lessthe than, than, the outer overall overall outer diameter diameter

of the of the outflow outflowendend portion portion of the of the valve. valve.

Furthermore,asasshown

[0104] Furthermore,

[0104] shownin in FIG. FIG. 56,the 56, valve1010comprises thevalve comprises commissure commissure portions portions of of the the leaflets extending leaflets extending radially radiallyoutwardly outwardly through through corresponding window corresponding window frame frame portion portion 30 30 to to locations outside of locations of the theframe frame and and sutured sutured to to the theside sidestruts of of struts thethe commissure commissurewindow frame. window frame.

To minimize To minimizethe thecrimp crimpprofile profileofofthe the valve, valve, the the window frameportions window frame portions3030can canbebedepressed depressed radially inwardly radially inwardly relative relative to to thethe surrounding surrounding portions portions of the of the frame, frame, such as such as the the frame frame portions portions extending between extending betweenadjacent adjacentcommissure commissure windows, windows, when when the valve the valve is radially is radially compressed compressed to theto the collapsed configuration collapsed configuration on on the the shaft. shaft. For For example, the commissure example, the commissurewindows windows 30the 30 of of the frame frame

can be can depressed inwardly be depressed inwardlya aradial radial distance distance of between 0.2 mm between 0.2 mm and and 1.01.0 mmmm relative relative to to the the

portions of portions of the the frame frame extending betweenadjacent extending between adjacentcommissure commissure windows windows when when the valve the valve is is radially collapsed. radially collapsed.In In this this way, way, the the outer outer diameter diameter of the of the outflow outflow endthe end portion portion valve the valve comprisingthe comprising the commissure commissure portions portions can can be be generally generally consistent,asasopposed consistent, opposedto to thecommissure the commissure portions jutting portions jutting outward outward from the surrounding from the surrounding portions portions of of the the valve, valve, which could hinder which could hinder delivery delivery of the of the valve valve into intothe thebody. body. Even with the Even with the radially radially depressed depressed commissure window commissure window frames frames 30, 30, the the

outer diameter outer diameterof of thethe inflow inflow end end portion portion of theof the can frame frame canbestill still be smaller smaller than, or than, about equal to, or about equal to, the outer the outerdiameter diameterof of thethe outflow outflow end portion end portion of the of the when frame frame thewhen valve the valve iscollapsed is radially radially collapsed on the on the shaft, shaft,allowing allowing for fora aminimal minimal maximum overalldiameter maximum overall diameter of of thevalve. the valve.ByBy minimizing minimizing the the diameter of diameter of the the valve when mounted when mounted on on thethe deliveryshaft, delivery shaft,the the assembly assemblycan cancontained containedwithin within a a

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30 Jul 2023

smaller diameter smaller diameter catheter catheter and and thus thus can can be be passed throughsmaller passed through smaller vessels vessels in in the the body and can body and can be be less invasive in general. less invasive in general.

2023208213 28

[0105] FIG.

[0105] 44illustrates FIG. 44 prostheticheart illustrates aaprosthetic heartvalve 200, valve 200, anotherembodiment. accordingtotoanother according The embodiment. The

heart valve 200 includes a frame, or stent, 202 and a leaflet structure 204 mounted on the stent. heart valve 200 includes a frame, or stent, 202 and a leaflet structure 204 mounted on the stent.

The leaflet structure 204 can include a plurality of leaflets 218 (e.g., three, as depicted), which The leaflet structure 204 can include a plurality of leaflets 218 (e.g., three, as depicted), which

can be can sutured to be sutured to each each other other and and to to the the frame frame 202 202 using suitable techniques using suitable techniques and/or and/or mechanisms. mechanisms.

The frame The frame202 202can canbebeadapted adaptedtotoinclude includecommissure commissure frame frame portions portions 30 (as 30 (as shown shown in FIG. in FIG. 4) 4) to to assist in suturing the leaflets to the frame. assist in suturing the leaflets to the frame.

frame202 Theframe

[0106] The

[0106] 202shares some sharessome design design featuresof of features the frame12 12 theframe described described above. above. In In particular, like frame 12, the frame 202 has relatively large frame openings 206 along the area of particular, like frame 12, the frame 202 has relatively large frame openings 206 along the area of

the frame that supports the leaflet structure, as shown in FIG. 45. The openings 206 are defined the frame that supports the leaflet structure, as shown in FIG. 45. The openings 206 are defined

by a row of angled struts 208 at the outflow end of the frame, a plurality of axially extending, by a row of angled struts 208 at the outflow end of the frame, a plurality of axially extending,

circumferentially spaced circumferentially struts 210, spaced struts 210, and and an an intermediate intermediate row of angled row of struts 212. angled struts 212. As shown, As shown,

the axial struts 210 desirably are thinner than the junctions 214 connecting the opposite ends of the axial struts 210 desirably are thinner than the junctions 214 connecting the opposite ends of

the axial struts 210 to the convergence of two struts 212 and to the convergence of two struts the axial struts 210 to the convergence of two struts 212 and to the convergence of two struts

208. By 208. Byvirtue virtue of of this this configuration, configuration, the the width width of ofopenings openings 206 remain large 206 remain large enough enoughwhen whenthethe

valve is radially compressed to a delivery configuration to allow portions of the leaflet structure valve is radially compressed to a delivery configuration to allow portions of the leaflet structure

204 to 204 to protrude outwardly through protrude outwardly throughthe theopenings, openings,asasindicated indicated at at 216 216 in in FIGS. FIGS. 4646and and47. 47.This This allows the valve to be crimped to a relatively smaller diameter than if all of the leaflet material allows the valve to be crimped to a relatively smaller diameter than if all of the leaflet material

is constrained is constrained within within the the crimped crimped frame. frame.

[0107] For

[0107] FIG.4848 comparison,FIG. purposesofofcomparison, For purposes is isa across crosssection of aa known section of knownprosthetic 250 valve250 prosthetic valve showing thevalve showing the valve inin its its crimped state. When crimped state. thevalve When the valveisis radially radially compressed, the spacing compressed, the spacing between adjacent struts is relatively small and does not allow portions of the leaflet structure to between adjacent struts is relatively small and does not allow portions of the leaflet structure to

protrude outwardly through the frame. Consequently, the presence of all of the leaflet material protrude outwardly through the frame. Consequently, the presence of all of the leaflet material

being constrained within the inside of the frame limits the crimping diameter of the valve. being constrained within the inside of the frame limits the crimping diameter of the valve.

[0108] and5050show FIGS.4949and

[0108] FIGS. show sectionofofananalternative a flattenedsection a flattened frame construction alternative frame construction that can that can allow portions of the leaflets to protrude outwardly through the frame in the crimped state. This allow portions of the leaflets to protrude outwardly through the frame in the crimped state. This

frame construction can frame construction can be be implemented implementedin inthe thevalve valve1010described describedabove. above.FIG. FIG. 49 49 shows shows the the

frame section in frame section in the the radially radiallycompressed state while compressed state while FIG. FIG. 50 showsthe 50 shows the frame framesection section in in the the radially expanded state. The frame (only a portion of which is shown) includes a first, radially expanded state. The frame (only a portion of which is shown) includes a first,

circumferentially extending row of angled struts 442 and at least a second, circumferentially circumferentially extending row of angled struts 442 and at least a second, circumferentially

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extending row extending rowofofangled angledstruts struts 444. 444. Some Some openings openings in in thethe frame frame areare diamond diamond shaped shaped openings openings

446 formed by adjacent struts 442 connected to each other at their upper ends and adjacent struts 446 formed by adjacent struts 442 connected to each other at their upper ends and adjacent struts

444 connected 444 connectedtotoeach eachother otheratat their their lower lower ends. The frame ends. The framealso also includes includes larger larger openings openings448 448 that are formed by adjacent struts 442 connected at their upper ends to respective ends of a that are formed by adjacent struts 442 connected at their upper ends to respective ends of a

horizontal strut 450 and by adjacent struts 444 connected at their lower ends to respective ends horizontal strut 450 and by adjacent struts 444 connected at their lower ends to respective ends

2023208213 of a horizontal strut 452. When the frame is radially compressed, the horizontal struts 450, 452 of a horizontal strut 452. When the frame is radially compressed, the horizontal struts 450, 452

maintains the maintains the width width WWofofopenings openings448 448large largeenough enough to to permit permit portions portions of of thethevalve's valve'sleaflets leaflets to to protrude outwardly protrude outwardlythrough throughthe theframe. frame.Thus, Thus,thethewidth width of of openings openings 448448 is is greaterthan greater thanthe thewidth width of openings of 446 when openings 446 whenthetheframe frameisiscrimped. crimped.TheThe frame frame can can be formed be formed with with openings openings 446, 446, 448 448 alternating around alternating the circumference around the of the circumference of the frame. frame. Alternatively, Alternatively, openings openings 448 448can canbebelocated locatedatat selected positions selected positions along along the the frame's frame's length length and and circumference to correspond circumference to correspondtoto areas areas where wherethe the leaflet material leaflet materialtend tendtoto bunch bunchup up within withinthe theframe, frame,such such as asbetween between the the commissures. commissures.

[0109] and5252show FIGS.5151and

[0109] FIGS. show a flattened anotherframe sectionofofanother a flattenedsection constructionthat frameconstruction allow canallow thatcan portions of the leaflets to protrude outwardly through the frame in the crimped state. This frame portions of the leaflets to protrude outwardly through the frame in the crimped state. This frame

construction can construction can be be implemented implementedininthe thevalve valve1010described describedabove. above.FIG. FIG. 51 51 shows shows the the frame frame

section in the radially compressed state while FIG. 52 shows the frame section in the radially section in the radially compressed state while FIG. 52 shows the frame section in the radially

expanded state. The frame (only a portion of which is shown) includes a first, circumferentially expanded state. The frame (only a portion of which is shown) includes a first, circumferentially

extending row extending rowofofangled angledstruts struts 402 402 and and atat least least aasecond, second, circumferentially circumferentially extending extending row of row of

angled struts angled struts 404. Someopenings 404. Some openingsininthe theframe framearearediamond diamond shaped shaped openings openings 406 406 formed formed by by adjacent struts 402 connected to each other at their upper ends and adjacent struts 404 connected adjacent struts 402 connected to each other at their upper ends and adjacent struts 404 connected

to each to each other other at at their theirlower lowerends. ends.The The frame also includes frame also includes openings 408 that openings 408 that are are formed by formed by

adjacent struts adjacent struts 402 402 connected at their connected at theirupper upper ends ends to toan an enlarged enlargednode node or or junction junction 410 410 and and by by

adjacent struts adjacent struts 404 404 connected at their connected at theirlower lower ends ends to toan an enlarged enlarged node node orjunction or junction 412. 412. The The

junctions 410, 412 add rigidity to the frame at those locations such that when the frame is junctions 410, 412 add rigidity to the frame at those locations such that when the frame is

radially compressed, radially the width compressed, the width WWofofopenings openings408 408remains remains large large enough enough to permit to permit portions portions of of the valve's the valve's leaflets leafletstoto protrude outwardly protrude outwardlythrough through the theframe. frame. Thus, Thus, the the width width of of openings 408 is openings 408 is greater than greater than the the width width of of openings openings 406 whenthe 406 when theframe frameisiscrimped. crimped.The The frame frame cancan be be formed formed

with openings with openings 406, 406,408 408alternating alternating around aroundthe the circumference circumferenceofofthe theframe. frame.Alternatively, Alternatively, openings 408 openings 408can canbebelocated locatedatat selected selected positions positions along along the the frame's frame's length length and and circumference to circumference to

correspond to areas where the leaflet material tend to bunch up within the frame, such as correspond to areas where the leaflet material tend to bunch up within the frame, such as

betweenthe between thecommissures. commissures.

[0110] FIG. 57 shows a leaflet 500 for a prosthetic valve (e.g., valve 10 or 200), according to

another embodiment. another embodiment.TheThe leaflet500500 leaflet hashas an an overallV-shape, overall V-shape, similar similar totoleaflets leaflets 40 40 described described

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above.TheThe above. leaflet leaflet 500500 has has twoportions two tab 502 on 502 tab portions on opposite opposite sides sides of the of thewhich leaflets leaflets are which are securedtotoadjacent secured adjacenttabtab portions portions of other of other leaflets leaflets to form to form the commissures the commissures of thestructure. of the leaflet leaflet structure. The sub-commissure The sub-commissure portion portion of of thetheleaflet leaflet 500 500(the (the portion portion below belowthe thetabs tabs 502) 502) include include two two substantiallystraight substantially straightedges edges 504504 thatthat extend extend from respective from respective locations locations just just below thebelow thetotabs tabs 502 502 to a curved a lower edge curved lower edge 506. 506. FIG. FIG.5858shows shows thethe general general shape shape of of thethe leaflet500 leaflet 500when whenthethe valve valve is is

crimped. The crimped. Theframe frame(not (notshown shown in in FIGS. FIGS. 57-58) 57-58) slightly slightly elongates elongates when when crimped, crimped, causing causing the the leaflet 500 leaflet to become 500 to become slightly slightly elongated. elongated.

[0111] The

[0111] profile of taperedprofile Thetapered the sub-commissure of the portionofofthe sub-commissure portion leaflet reduces the amount theleaflet of amount of

leaflet material leaflet inthe material in thelower lower half half of of thethe crimped crimped valvevalve to minimize to minimize the crimpthe crimp ofdiameter diameter that of that portionofofthe portion thevalve. valve.Thus, Thus, if additional if additional components components are to are mounted mounted to that that portion of portion of the valve, the valve, suchasasananouter such outerskirt skirt18,18,thethe reduced reduced profile profile of that of that portion portion of theof the valve valve can can help helporoffset offset or minimizethe minimize theincrease increase in in diameter diameter caused causedbybythe the additional additional component. component.Additionally, Additionally, thethe

commissuretabs commissure tabs502 502arearerelatively relatively short short and and require require less less sutures sutures for forforming forming the the commissures of commissures of

the leaflet the leaflet structure structure than thanknown known leaflet leaflet designs designs (such (such as T-shaped as T-shaped and scalloped and scalloped leaflets), leaflets), which which better distributes better distributesand andreduces reduces the the bulkiness bulkiness ofleaflet of the the leaflet material material when when the theis valve valve is crimped. crimped.

FIG. 59

[0112] FIG.

[0112] showsa across-sectional 59 shows viewofofa avalve cross-sectionalview accordingtotoanother 500,according valve500, embodiment. anotherembodiment. The valve The valve 500 500comprises comprisesa aframe frame502, 502,leaflets leaflets 504, 504, and andananouter outer skirt skirt 18 18 mounted (e.g., by mounted (e.g., by

sutures) toto the sutures) the outer outersurface surface of of thethe frame frame 502. 502. The 502 The frame frame has a502 has a thickness thickness that varies that varies along along its its length to optimize length to optimizestrength strength where where needed, needed, yet minimize yet minimize material material (and crimp (and therefore therefore crimp profile) profile)

at selected at selected regions regions of ofthe theframe. frame. In Inthe theembodiment shown,the embodiment shown, theoutflow outflowend end portion506 portion 506 of of the the

frame has aa maximum frame has maximum thickness thickness T1 Ti (measured (measured from from the inside the inside diameter diameter to the to the outside outside diameter diameter

of that of that portion portionof ofthe theframe) frame)and andthe theinflow inflowend endportion portion508 508 of ofthe theframe framehas has aaminimum minimum

thicknessT2T2 thickness (measured (measured from from the inside the inside diameter diameter to the diameter to the outside outside ofdiameter of that that portion portion of the of the frame). ItItshould frame). shouldbe be noted noted thatthat the the struts struts of frame of the the frame 502 (which 502 (which are not are not shown shown in FIG. 59) in FIG. that 59) that form the form the outflow outflow end endportion portion 506 506have havea athickness thicknessT1TIand andthe thestruts struts that that form the inflow form the inflow end end portion 508 portion 508 have have aa thickness thickness T2. T2. The Theframe frame502502 cancan have have an an identicalconstruction identical constructiontotothe theframe frame 12 described above, 12 above, except except for for the the variable variable thickness thickness of of the theframe. frame. The areas of The areas of reduced reduced

thickness can thickness can be be formed formedusing usinga avariety variety of of manufacturing techniques,such manufacturing techniques, suchasaselectro-polishing electro-polishing selected portions selected portions of of the theframe frame (the (thenon-polished non-polished portions portions can can be be masked), grinding selected masked), grinding selected portionsofofthe portions theframe, frame, wire wire cutting, cutting, or other or other suitable suitable techniques. techniques.

[0113] The

[0113] Theoutflow endportion outflowend 502generally portion502 to to corresponds generallycorresponds theregion the theframe regionofofthe that framethat supportsthe supports thecommissures commissures of theofleaflets the leaflets 504 504 and and typically typically experiences experiences theloading the greatest greatest on loading on

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the valve. the the outflow Therefore the valve. Therefore outflow end endportion 502ofofthe portion 502 the frame has aa greater framehas thickness T1 greater thickness TI selected to selected to provide provide the the required required strength strengthunder under anticipated anticipatedloads. loads. The The inflow inflow end end portion portion 508 508

supports an additional layer of material by virtue of the outer skirt 18. The reduced thickness of supports an additional layer of material by virtue of the outer skirt 18. The reduced thickness of

the inflow the inflow end portion 508 end portion allows the 508 allows the inflow inflow end end portion portion to to be be crimped to aa smaller crimped to smaller diameter diameter than the than the outflow end portion. outflow end portion. This This offsets offsets or or minimizes the increase minimizes the increase in in the the crimp crimp diameter diameter

caused by the addition of the outer skirt 18. caused by the addition of the outer skirt 18.

FIGS.60-62

[0114] FIGS.

[0114] an an show 60-62show another another embodiment of anof embodiment an implantable implantable prosthetic valvevalve prosthetic 310 310 that that comprises a leaflet structure 314 and a radially collapsible and expandable frame 312 (similar to comprises a leaflet structure 314 and a radially collapsible and expandable frame 312 (similar to

the frame the 50 shown frame 50 shownininFIG. FIG.11) 11)having havinga aplurality plurality of of radially radially spaced commissurewindows spaced commissure windows 318 318

that are used to secure the leaflet structure within the frame. The valve 310 also comprises a that are used to secure the leaflet structure within the frame. The valve 310 also comprises a

skirt 316 skirt 316 secured secured between the inner between the inner surface surface of of the the frame frame 312 and the 312 and the curved curved lower lower edges edges364 364ofof the leaflet the leafletstructure 314. structure 314.The Thevalve valve 310 310 has has aa lower, lower, inflow inflow end end 340 and an 340 and an upper, upper, outflow outflow end end 342. 342.

[0115] As

[0115] shown Asshown in in FIG. 60A, FIG.60A, each each window window 318 comprises 318 comprises an enclosed an enclosed opening opening 334 between 334 between

two axially extending side struts 320, respectively. Each side strut comprises a generally two axially extending side struts 320, respectively. Each side strut comprises a generally

rectangular, e.g. square, cross-sectional profile, as shown in FIG. 63. Each rectangular side strut rectangular, e.g. square, cross-sectional profile, as shown in FIG. 63. Each rectangular side strut

320 comprises 320 comprisesfour foursurfaces: surfaces: ananexterior exterior surface surface 324 324 ononaa radially radially outward facing side, outward facing side, and and

interior surface 326 on a radially inward facing side, a medial surface 328 on a side facing the interior surface 326 on a radially inward facing side, a medial surface 328 on a side facing the

other side strut, and a lateral surface 330 on a side facing away from the other side strut. In other side strut, and a lateral surface 330 on a side facing away from the other side strut. In

other embodiments, side struts can comprise other cross-sectional shapes, such circular or other embodiments, side struts can comprise other cross-sectional shapes, such circular or

hexagonal. hexagonal.

[0116] The leaflet structure comprises a plurality of leaflets 360, each comprising a pair of side

tabs 366 tabs secured to 366 secured to the the frame 312, aa curved frame 312, lower edge curved lower edge364 364secured securedtotothe theskirt skirt 316, 316, and an and an

articulation portion 372 between the side tabs and the lower edge. Each side tab 366 is paired articulation portion 372 between the side tabs and the lower edge. Each side tab 366 is paired

with an adjacent side tab of another leaflet 360 to form commissures 376 of the leaflet structure with an adjacent side tab of another leaflet 360 to form commissures 376 of the leaflet structure

314. Each 314. Eachpair pairofofside side tabs tabs 366 extends radially 366 extends radially outwardly throughaa corresponding outwardly through correspondingcommissure commissure window 318 to a location outside of the frame 312 and is secured to the side struts 320 of the window 318 to a location outside of the frame 312 and is secured to the side struts 320 of the

window,such window, suchasaswith withsutures, sutures, as as shown shownininFIG. FIG.62. 62.InInsome some embodiments, embodiments, each each side side tab tab 366 366 comprises ananend comprises endportion portion368 368(see (seeFIG. FIG.64) 64)and andthe thetwo twoside sidetab tab end endportions portions368 368ofofeach each commissure376376extend commissure extend circumferentiallyaway circumferentially away fromfrom one one another another and along and along the exterior the exterior surfaces surfaces

324 of 324 of respective respective side side struts struts320 320of ofthe thewindow 318. window 318.

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[0117] In

[0117] In some someembodiments, embodiments, each each commissure commissure 376 further 376 further comprises comprises at least at least one one non-rigid non-rigid

reinforcingsheet reinforcing sheet378378 sutured sutured to side to the the side tabs tabs 366toand 366 and the to thestruts side side 320. struts The320. sheetsThe 378 sheets can 378 can comprisea flexible, comprise a flexible,tear tear resistant resistant material, material, including including a variety a variety of natural of natural and/or and/or synthetic synthetic

biocompatiblematerials. biocompatible materials. Exemplary Exemplary synthetic synthetic materials materials can can include include polymers polymers such such as nylon, as nylon,

silicone, and silicone, and polyesters, polyesters,including includingPET. In one PET. In example, the one example, the sheets sheets 378 378 comprise comprisea awoven wovenPETPET

fabric. fabric.

Eachreinforcing

[0118] Each

[0118] reinforcing sheet canbebegenerally 378can sheet 378 generallyrectangular (whenlaid rectangular(when flat) and laidflat) can and can

comprise aa middle comprise middleportion portion380 380and andopposing opposing endend portions portions 386. 386. In In some some embodiments, embodiments, a first a first

endportion end portion386386 of of thethe sheet sheet is secured is secured to a to a first first sideside strutstrut 320a and 320 and a second second end 386 end portion portion of 386 of the sheet the sheetisis secured securedtotothethesecond second sideside strut strut 320,320, as shown as shown in FIG.in64. FIG. The 64. sheetThe sheet 378 378 separates separates the side the side tabs tabs366 366from from the the sideside struts struts 320 320 such such that tabs that side sidedotabs not do not contact contact the sidethe side For struts. struts. For example, each example, eachend endportion portion386 386ofofthe thesheet sheet can can be be wrapped wrappedcompletely completely around around a respective a respective side side

strut 320, strut as shown 320, as shownin in FIG. FIG. 64. 64.

The

[0119]The

[0119] side side 366 366 tabs tabs and the the reinforcing andreinforcing sheet 378 can 378 sheet be secured the sideto can betosecured the side struts struts 320 in 320 in multiple stages. multiple stages. For example, FIG. For example, FIG.6363shows showsan an exemplary exemplary firstsuturing first suturingstage stagewherein whereinthethe

sheet is sheet is positioned positionedsuch such that that thethe middle middle portion portion 380 of380 the of theextends sheet sheet extends circumferentially circumferentially across across outer surfaces outer surfacesofofthetheendend portions portions 368 368 ofside of the the tabs side 366 tabsand366 and each endeach end386 portion portion of the 386 sheetof the sheet extendsbetween extends between a respective a respective side366 side tab taband 366 theand the exterior, exterior, medial medial and andsurfaces interior interior324, surfaces 324, 328, 326, 328, 326,respectively, respectively,of of a respective a respective side side strutstrut 320. 320. The 378 The sheet sheet 378 surrounds surrounds the 366 the side tabs side tabs 366 andprotects and protectsthe theside sidetabs tabs from from edges edges ofside of the the struts side struts 320. A320. pair A of pair of in-and-out in-and-out sutures sutures 390 can 390 can secure each secure each side side tab tab 366 and one 366 and one end endof ofthe the sheet sheet 378 to aa respective 378 to respective strut strut320. 320.As As shown in shown in

FIG. 63, FIG. 63, each each suture suture 390 390 can can be be oriented oriented generally generally perpendicularly perpendicularly to to the the circumference ofthe circumference of the frame 312 frame 312 along along the the lateral lateral surfaces surfaces 330 330 of theof thestruts side side struts 320 and320 can and passcan pass back radially radially and back and

forth through forth throughthethecommissure commissure 376 at376 at a plurality a plurality of difference of difference longitudinal longitudinal positions.positions. Each suture Each suture 390can 390 canintersect intersecta first a firstlayer layerofof thesheet the sheet 378, 378, a side a side tab tab end portion end portion 368, a368, a second second layer oflayer the of the sheet, and sheet, anda athird thirdlayer layerofofthethesheet, sheet,in in that that order order moving moving radially radially inward. inward. The390 The sutures sutures 390 securethe secure thesheet sheet378378 to to thethe side side tab tab end end portions portions 368 368 and and tighten tighten theendsheet the sheet end 386 portions portions 386 aroundthe around theside sidestruts struts 320, 320, thereby thereby securing securing the tabs the side side366 tabs to 366 to the the side side320 struts struts and 320 and securing securing the leaflet the leaflet structure structure 314 314totothetheframe frame 312.312.

FIG. 64

[0120] FIG.

[0120] showsananexemplary 64 shows exemplary second second suturing suturing stage stage wherein wherein a second a second pairpair of sutures 392392 of sutures are used are used to to tie tiedown down loose portions portions of of the thereinforcing reinforcingsheet sheet378. 378.For For example, example, the the second second

sutures 392cancan sutures 392 intersect intersect thethe portions portions of middle of the the middle portion portion 380 and 380 andportions the end the end386 portions of the 386 of the

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35 28 Jul 2023

sheet that sheet that extend extendlaterally laterallybeyond beyond the first the first sutures sutures 390. 390. The sutures The second second 392 sutures can be392 can helical be helical whipstitches whip stitchesthat thatintersect intersectthethe commissures commissures 376 at376 at a plurality a plurality of different of different longitudinal longitudinal positions,positions,

as shown as shown in in FIG. FIG. 62, 62, and and secure secure the loose the loose portions portions of the378sheet of the sheet 378against tightly tightlythe against lateralthe lateral surfaces 330 surfaces 330of of the the side side struts. struts.

2023208213

[0121] Both

[0121]Both thethe first first sutures 390390 sutures and the the second andsecond 392 can 392 suturessutures be positioned adjacent to adjacent can be positioned the to the lateral surfaces lateral surfaces330 330 of ofthe thestruts 320320and struts andspaced spacedaway away from the window from the opening334. window opening 334.This This placementofofthe placement the sutures sutures can can reduce reduce the the stress stress on on the the sutures suturescaused caused by by movement movement ofofthe the articulation portions articulation portions372372 of of thethe leaflets. leaflets. Instead, Instead, much much of thisof this stress stress is transferred is transferred from from flex flex hinges370 hinges 370of of thethe leaflets leaflets to to thethe side side struts struts 320320 nearnear interior-medial interior-medial edges edges 332 332struts. of the of the struts.

[0122] The

[0122] Thereinforcing reinforcing sheet sheet 378 378protects protects the the flex flex hinges hinges 370 from damage 370 from damagecaused caused by by thethe

interior-medial edges interior-medial edges 332332 of struts of the the struts 320theasleaflets 320 as the leaflets articulate articulate between between open and open closedand closed

positions, as positions, as shown in FIG. shown in 64. In FIG. 64. In addition, addition, some embodiments some embodiments cancan also also include include longitudinally longitudinally

extending cushion extending cushionstrips strips 374 374 positioned positioned between betweenthe theflex flex hinges hinges 370 370and andthe thestruts struts 320, 320, such such as as adjacenttotothe adjacent theinterior-medial interior-medial edges edges 332, 332, as shown as shown in FIG. in 64,FIG. 64, to protect to further furtherthe protect the flex flex hinges hinges from damage from damagecaused caused by by thethe struts. The struts. Thecushion cushion strips374 strips 374can cancomprise comprise a flexible,compressible a flexible, compressible material, such material, suchasasPETPET fabric, fabric, pericardial pericardial tissue, tissue, or various or various other other biocompatible biocompatible materials.materials. In In someembodiments, some embodiments,thethe cushion cushion stripscancan strips comprise comprise a tube a tube filledwith filled witha aresilient resilient material. material. For

example,thethe example, cushion cushion strip strip can can comprise comprise a PET a PET tube tubewith filled filled with pericardial pericardial tissue. In tissue. other In other embodiments,the embodiments, theouter outertubular tubularcovering coveringofofthe the cushion cushionstrips strips can can be be formed formedfrom fromsheet sheet378 378and and can be can befilled filledwith witha aresilient resilientmaterial. material.The The sheetsheet can can be be secured secured around around the the resilient resilient material material withsutures with suturestotoretain retainthethecushioning cushioning strips strips properly properly located located as inshown as shown in FIG. FIG. 64. 64. In other In other embodiments,separate embodiments, separatecushion cushionstrips strips374 374can canbebesutured suturedtotothe the reinforcing reinforcing sheet sheet 378. 378. The The cushionstrips cushion strips374374 cancan havehave a thickness a thickness similar similar to the to the62bars bars 62 to provide to provide a radial a radial clearance clearance

between between thethe side side struts struts 320320 and and the articulating the articulating portions portions 372 of 372 of the leaflets the leaflets to prevent to prevent or or minimize minimize contact contact between between the leaflets the leaflets and and the thesurface inner inner surface of the of the frame frame during the during cardiac the cardiac cycle. cycle.

[0123] FIG.

[0123] FIG. 65 65 shows showsananembodiment embodiment similar similar to FIGS. to FIGS. 63 and 63 and 64 but 64 but withwith a different a different suturing suturing

pattern. InInFIG. pattern. FIG.65,65, thethe sutures sutures 390 390 are replaced are replaced with sutures with sutures 398 that398 thatthesecure secure sheet the 378 sheet 378 around the around the end end portions portions 368 368 of ofthe the side side tabs. tabs. Each suture 398 Each suture 398 intersects intersects the the middle middle portion portion 380 380

of the of the sheet, sheet, one oneofofthe theside side tabs tabs 366, 366, and and a second a second layer layer of the of the adjacent sheet sheet adjacent to the to the medial- medial exterior edge exterior edge324324 of of each each sideside strut. strut. The sutures The sutures 398 can398 can comprise comprise in-and-out in-and-out stitches stitches that that intersect the intersect the commissures commissuresat a at a plurality plurality of different of different longitudinal longitudinal positions. positions. Each endEach end portion of portion of

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36 28 Jul 2023

the sheet 378 can comprise a folded portion 388 that is folded under to form a double layer of the sheet 378 can comprise a folded portion 388 that is folded under to form a double layer of

the sheet 378 along the surface of the respective side strut 320. The sutures 392 secure the end the sheet 378 along the surface of the respective side strut 320. The sutures 392 secure the end

portions 386 of the sheet and the end portions 368 of the side tabs tightly around the lateral portions 386 of the sheet and the end portions 368 of the side tabs tightly around the lateral

surfaces 330 of the side struts. surfaces 330 of the side struts.

2023208213

[0124] and6767show FIGS.6666and

[0124] FIGS. an an show alternative forfor method alternativemethod suturing suturing theside the sidetabs 366and tabs366 sheet andthethesheet 378 to the side struts 320. FIG. 66 shows suture line 394 positioned along the exterior surfaces 378 to the side struts 320. FIG. 66 shows suture line 394 positioned along the exterior surfaces

324 of the side struts and generally perpendicular to the radius of the frame. The suture 394 324 of the side struts and generally perpendicular to the radius of the frame. The suture 394

intersects intersectsboth both side sidetabs tabs366 366and andboth both end end portions portions 386 386 of of the the sheet sheet378. 378. The The suture suture 394 394 secures secures

each end portion 386 of the sheet tightly around the medial, interior, and lateral surfaces 328, each end portion 386 of the sheet tightly around the medial, interior, and lateral surfaces 328,

326, 330,respectively, 326, 330, respectively,of of thethe respective respective side side strutstrut 320, 320, andsecures and also also secures the portion the middle middle380 portion 380 of the of the sheet sheet loosely looselyaround around the the end end portions portions 368 368 of of the the side sidetabs tabs366. 366.In Inthe theembodiment shown embodiment shown

in FIG. 66, the suture 394 intersects a first sheet layer A, a second sheet layer B, the two side in FIG. 66, the suture 394 intersects a first sheet layer A, a second sheet layer B, the two side

tabs 366, a third sheet layer C, and a fourth sheet layer D, in that order. tabs 366, a third sheet layer C, and a fourth sheet layer D, in that order.

[0125] After the first suture 394 is in place, the end portions 368 of the side tabs are spread apart

and positioned adjacent to the exterior surfaces 324 of the side struts 320, as shown in FIG. 67. and positioned adjacent to the exterior surfaces 324 of the side struts 320, as shown in FIG. 67.

This tightens the loose middle portion 380 of the sheet around the end portions 368 of the side This tightens the loose middle portion 380 of the sheet around the end portions 368 of the side

tabs. A pair of sutures 396 can then secure the middle portion 380 of the sheet tightly to the end tabs. A pair of sutures 396 can then secure the middle portion 380 of the sheet tightly to the end

portions 386 of the sheet to hold the end portions 368 of the side tabs in place, as shown in FIG. portions 386 of the sheet to hold the end portions 368 of the side tabs in place, as shown in FIG.

67. The 67. Thesutures sutures 396 396can canbebelooping loopingwhip whipstitches stitchesthat that intersect intersect the the commissure 376atataa commissure 376

plurality of different longitudinal positions, similar to the sutures 392 in FIG. 64. plurality of different longitudinal positions, similar to the sutures 392 in FIG. 64.

[0126] FIGS.6868and

[0126] FIGS. show and6969show another another alternative method alternativemethod for for suturing thethe suturing side tabs366 sidetabs andthethe 366and sheet 378 to the side struts 320. FIG. 68 shows a suture line 395 positioned along the exterior sheet 378 to the side struts 320. FIG. 68 shows a suture line 395 positioned along the exterior

side of side of the thewindow openingand window opening andoriented orientedgenerally generallyperpendicular perpendiculartotothe theradius radiusofofthe the frame. frame. The The suture 395 intersects both side tabs 366 and two portions of the sheet 378. The suture 395 suture 395 intersects both side tabs 366 and two portions of the sheet 378. The suture 395

secures the secures the middle portion 380 middle portion 380 of of the the sheet sheet which extends loosely which extends loosely around aroundthe the end endportions portions 368 368 of the side tabs 366. In the embodiment shown in FIG. 68, the suture 395 intersects a first sheet of the side tabs 366. In the embodiment shown in FIG. 68, the suture 395 intersects a first sheet

layer A, a first side tab B, a second side tab C, and a second sheet layer D, in that order. layer A, a first side tab B, a second side tab C, and a second sheet layer D, in that order.

[0127] After the first suture 395 is in place, the end portions 368 of the side tabs are spread apart

and positioned adjacent to the exterior surfaces 324 of the side struts 320, as shown in FIG. 69. and positioned adjacent to the exterior surfaces 324 of the side struts 320, as shown in FIG. 69.

tabs. A pair of sutures 397 can then secure the middle portion 380 of the sheet tightly to the end tabs. A pair of sutures 397 can then secure the middle portion 380 of the sheet tightly to the end

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portions386 portions 386of of thethe sheet sheet to hold to hold the the end portions end portions 368 of368 of the the side side tabs in tabs inasplace, place, shown as in shown FIG. in FIG. 69. The 69. Theend endportions portions386 386ofofthe the sheet sheet can can comprise comprisea afolded foldedunder underportion portion388, 388,creating creatingaa double layer double layer of of sheet sheet material material to toreinforce reinforcethe thesutures 397. sutures 397.The The sutures sutures397 397 can can be be looping looping whip whip

stitches that stitches that intersect intersect the the commissure commissure 376 376 at at a plurality a plurality of different of different longitudinal longitudinal positions, positions, similar toto the similar thesutures sutures392 392 in in FIG. FIG. 62. 62.

2023208213

[0128] FIGS.

[0128] show and7171show FIGS.7070and yetyet another another alternative method alternativemethod forfor suturing sidetabs suturingthetheside tabs366 and 366and the sheet the sheet378 378totothetheside side struts struts 320. 320. FIG.FIG. 70 shows 70 shows the line the suture suture 395line 395 positioned positioned along the along the exterior side exterior sideofofthe thewindow window opening opening and oriented and oriented generallygenerally perpendicular perpendicular to of to the radius thetheradius of the frame. The frame. The suture suture 395 395 intersects intersects bothtabs both side side366 tabs and366 fourand four portions portions or layers or layers of the of378. sheet the sheet 378. Each end Each endportion portion 386 386ofofthe the sheet sheet comprises comprises aafolded folded portion portion 388 388that that forms formsaa double doublelayer layer of of sheet material sheet materialbetween between the the side side tabs tabs 366the 366 and and the medial medial surfaces surfaces 328 of the328 sideofstruts. the side Thestruts. The suture 395 suture secures the 395 secures the middle portion 380 middle portion 380 of of the the sheet sheet loosely loosely around the end around the end portions portions 368 of 368 of

the side the side tabs tabs366. 366.As As shown shown in 70, in FIG. FIG. 70,stitch each each ofstitch of the395 the suture suture 395 intersects intersects a first a first pair of pair of sheet layers sheet layerscomprising comprising layers layers A andAB, and B, a side a first first tab sideC,tab C, a second a second side tab side taba D, D, and andpair second a second pair of sheet of sheet layers layerscomprising comprising layers layers E andEF, and in F, inorder. that that order.

[0129]After

[0129] After the the firstsuture first suture 395395 is place, is in in place, the the end end portions portions 368 of368 the of thetabs side aretabs side spread are apart spread apart andpositioned and positioned adjacent adjacent to the to the exterior exterior surfaces surfaces 324 of324 the of thestruts side side 320, strutsas 320, shownas inshown FIG. 71.in FIG. 71. This tightens This tightensthe themiddle middle portion portion 380 380 of theof the sheet sheet around around the end portions the end portions 368 of the 368 side of the Aside tabs. tabs. A pair of pair of sutures sutures397 397cancan then then secure secure the middle the middle portionportion 380sheet 380 of the of the sheettotightly tightly the endtoportions the end portions 386ofofthe 386 thesheet sheettotohold hold thethe endend portions portions 368 368 of theof thetabs side sideintabs in place, place, as shownasin shown in The FIG. 71. FIG. 71. The foldedportions folded portions388388 of the of the sheet sheet create create a double a double layer layer of ofmaterial sheet sheet material to reinforce to reinforce the the sutures sutures 397. The 397. Thesutures sutures397 397can canbebelooping loopingwhip whip stitchesthat stitches that intersect intersect the the commissure 376atata a commissure 376

plurality of plurality ofdifferent differentlongitudinal longitudinal positions, positions, similar similar to sutures to the the sutures 392 392 in in62. FIG. FIG. 62.

The

[0130]The

[0130] variousvarious commissure commissure configurations configurations for attaching the leafletthe for attaching structure structure leaflet 314 to the 314 to the windowframes window frames 318318 shown shown in FIGS. in FIGS. 61-71 61-71 can also can also be used be used as alternative as alternative waysways to attach to attach thethe

leaflet structure leaflet 14ofofthe structure 14 thevalve valve 10 10 of FIGS. of FIGS. 1-3thetowindow 1-3 to the window frame 30 frame portions portions of frame30 12.of frame 12.

[0131] FIGS.72-74

[0131] FIGS. show 72-74show a prosthetic heartvalve a prostheticheart assembly valveassembly 600600 comprising comprising an embodiment an embodiment of a of a frame 602 frame 602 for for aa prosthetic prosthetic valve valve mounted ona aballoon mounted on balloon606 606ofofa adelivery delivery shaft shaft 604. 604. The Theframe frame 602 can 602 can be be similar similar in shape shape to to the the frame frame 12 and can comprise inin inflow can comprise inflow end endportion portion 610, 610, an an outflow end outflow endportion portion 612 612and andananintermediate intermediateportion portion614. 614.For For clarity, the clarity, the other other components componentsofof the valve, the valve, such suchasasthethe leafletsandand leaflets thethe skirts, skirts, areare not not shown. shown. The602 The frame frame 602 acan can have have reduced a reduced

AH25(42477228_1):BJM

38 Jul 2023

thickness at the inflow end portion 610 and at the outflow end portion 612, relative to the thickness at the inflow end portion 610 and at the outflow end portion 612, relative to the

thickness of thickness of the the intermediate intermediate portion portion 614. 614. Due to the Due to the thinner thinner end end portions, portions, when the balloon when the balloon 606 is inflated the end portions 610, 612 offer less resistance to expansion and expand faster 606 is inflated the end portions 610, 612 offer less resistance to expansion and expand faster

2023208213 28

than the than the intermediate intermediate portion portion 614, 614, as as shown in FIG. shown in FIG. 73. 73. Because Becausethe theend endportions portionsexpand expand faster faster

than the than the intermediate intermediate portion, portion, the theframe frame 602 602 becomes confinedononthe becomes confined theballoon balloon606, 606,inhibiting inhibitingthe the frame from frame from sliding sliding towards towards either either end ofend theof the balloon balloon and reducing and reducing thetherisk the risk of ofsliding frame the frame sliding off the balloon prematurely. As shown in FIG. 74, further inflation of the balloon can cause the off the balloon prematurely. As shown in FIG. 74, further inflation of the balloon can cause the

intermediate portion intermediate portion 614614 of frame of the the frame to expand to expand to the to the same same final final as diameter diameter the end as the end portions portions

610, 610, 612 for implantation, 612 for implantation, after after which which the the balloon balloon can can be be deflated deflated and and removed. Controllingthe removed. Controlling the position of the valve on the balloon can be important during delivery, especially with frames position of the valve on the balloon can be important during delivery, especially with frames

that foreshorten that foreshorten during during expansion and move expansion and moverelative relativetoto the the balloon. balloon. In In the the embodiment embodimentshown shown in FIGS.72-74, in FIGS. 72-74,thethe intermediate intermediate portion portion 614 of614 the of thecan frame frame canconstant be held be heldrelative constantto relative the to the balloon while balloon while the the two endportions two end portions foreshorten foreshorten towards towardsthe theintermediate intermediate portion portion due duetoto the the "dog- "dog bone" effect bone" effect of of the the balloon. balloon. Any conventionalmeans Any conventional meanscancan be be used used to to produce produce thethe frame frame 602602 withwith

reduced thickness reduced thickness at at the the end end portions portions 610, 610, 612, 612, such such as as sanding downthe sanding down theend endportions portionswith withsand sand paper or paper or the the like. like. In Inone one embodiment, the end embodiment, the endportions portions 610, 610, 614 614ofofthe the frame framehave havea athickness thickness of about of about 0.37 0.37 mm whilethe mm while theintermediate intermediateportion portion614 614has hasa athickness thicknessofofabout about0.45 0.45mm. mm.

[0132] In

[0132] view ofofthe In view the many manypossible embodiments possibleembodiments to which the the to which principles of of principles thethe disclosed disclosed

invention may invention maybebeapplied, applied, it it should should be be recognized that the recognized that the illustrated illustratedembodiments are only embodiments are only

preferred examples of the invention and should not be taken as limiting the scope of the preferred examples of the invention and should not be taken as limiting the scope of the

invention. Rather, invention. Rather, the the scope of the scope of the invention invention is isdefined defined by by the thefollowing following claims. claims. We therefore We therefore

claim as our invention all that comes within the scope of these claims. claim as our invention all that comes within the scope of these claims.

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39 24 Jun 2025 2023208213 24 Jun 2025

CLAIMS CLAIMS

1. 1. An implantable prosthetic heart valve that is collapsible to a collapsed configuration and An implantable prosthetic heart valve that is collapsible to a collapsed configuration and

expandable to an expandable to an expanded expandedconfiguration, configuration,the thevalve valvecomprising: comprising: aa balloon-expandable annularframe balloon-expandable annular framehaving having anan inflow inflow endend portion portion andand an an outflow outflow endend

portion and portion being formed and being formedfrom froma aplastically-expandable plastically-expandablematerial materialincluding includingone oneorormore more of: of: 2023208213

aa leaflet leaflet structure positionedwithin structure positioned within the the frame, frame,

whereinthe wherein the frame framecomprises: comprises: an an inflow rowof inflow row of openings openingsatat the the inflow inflow end end portion, portion, an an outflow rowofof openings outflow row openings at at the the outflow outflow end end portion, portion, and and at atleast leastone oneintermediate intermediaterow rowof ofopenings openings between the between the

inflow rowof inflow row of openings openingsand andthe theoutflow outflowrow rowofofopenings, openings,wherein wherein thethe openings openings of of thethe

inflow row inflow row of of openings openings are larger are larger than than the openings the openings ofleast of the at the atoneleast one intermediate intermediate row row of of openings, openings, wherein the openings wherein the openingsofofthe the outflow outflowrow roware arelarger larger than than the the openings openingsof of the the inflow rowand inflow row andthe the openings openingsofofthe theat at least least one one intermediate intermediate row; row; and and

whereinthe wherein the outflow outflowrow rowofofopenings openingsisisformed formedbyby a a first row first rowofof angled angledstruts struts and and

aa second row second row of of angled angled struts, struts, connected connected to one to one another another by a plurality by a plurality of axially of axially

extending window extending window frame frame portions portions andand a pluralityofofaxially a plurality axiallyextending extendingstruts, struts, said said each each of of

the plurality the pluralityof ofaxially axiallyextending extendingwindow frame portions window frame portions configured configuredtoto mount mounta a respective commissure of the leaflet structure; respective commissure of the leaflet structure;

by a convergence of two lower ends of two angled struts of the first row of angled struts by a convergence of two lower ends of two angled struts of the first row of angled struts

to aa second to second location location defined defined by by a a convergence of two convergence of twoupper upperends endsofoftwo twoangled angledstruts strutsofof the second row of angled struts. the second row of angled struts.

2. 2. The valve The valve of of claim claim 1, 1, further further comprising an annular comprising an annular outer outer skirt skirt positioned positioned around around an an outer outer

surface ofthe surface of theframe, frame,thethe outer outer skirt skirt comprising comprising a lower a lower edge secured edge secured to the to the frame at aframe first at a first

location and location and an an upper edgesecured upper edge securedtoto the the frame frame at at aa second location, and second location, and an an intermediate intermediate portion portion

betweenthe between thelower loweredge edgeand andthe theupper upperedge, edge,wherein wherein when when the the valve valve is is in in theexpanded the expanded configuration, the intermediate portion of the outer skirt comprises a slack in the axial direction configuration, the intermediate portion of the outer skirt comprises a slack in the axial direction

between the lower edge of the outer skirt and the upper edge of the outer skirt, and when the between the lower edge of the outer skirt and the upper edge of the outer skirt, and when the

valve is collapsed to the collapsed configuration, the axial distance between the lower edge of valve is collapsed to the collapsed configuration, the axial distance between the lower edge of

AH26(46198026_1):BJM AH26(46198026_1):BJM

Claims

40 24 Jun 2025 2023208213 24 Jun 2025

the outer skirt and the upper edge of the outer skirt increases, reducing the slack in the outer skirt the outer skirt and the upper edge of the outer skirt increases, reducing the slack in the outer skirt

in in the axial direction. the axial direction.

3. 3. The valve of claim 2, wherein the outer skirt comprises a substantially straight lower The valve of claim 2, wherein the outer skirt comprises a substantially straight lower

edge, andwherein edge, and wherein the the upper upper edge edge of theof the skirt outer outercomprises skirt comprises a plurality a plurality of alternating of alternating

projections and projections notches. and notches. 2023208213

4. 4. The valve of claim 2 or 3, wherein the outer skirt is formed from a synthetic or natural The valve of claim 2 or 3, wherein the outer skirt is formed from a synthetic or natural

durable material. durable material.

5. 5. The valve The valve of of claim claim 4, 4, wherein the outer wherein the outer skirt skirt isisformed formed from from woven PET. woven PET.

6. 6. The valve of any one of claims 1 to 5, wherein the lower edge of the leaflet structure has The valve of any one of claims 1 to 5, wherein the lower edge of the leaflet structure has

an an undulating curvedscalloped undulating curved scallopedshape. shape.

7. 7. The valve of any one of claims 1 to 6, wherein the leaflet structure comprises a plurality The valve of any one of claims 1 to 6, wherein the leaflet structure comprises a plurality

of leaflets that of leaflets that each eachcomprise comprise opposing opposing sideontabs side tabs on opposite opposite sides ofsides of the leaflet, the leaflet, the opposing the opposing

side tabs configured side tabs configuredto to be be secured secured to outflow to the the outflow end portion end portion of the frame. of the frame.

8. 8. The valve of claim 7, wherein a respective side tab of a first leaflet of the plurality of The valve of claim 7, wherein a respective side tab of a first leaflet of the plurality of

leaflets is configured to be paired with an adjacent side tab of an adjacent leaflet of the plurality leaflets is configured to be paired with an adjacent side tab of an adjacent leaflet of the plurality

of leaflets to of leaflets to form form a acommissure commissure ofleaflet of the the leaflet structure. structure.

9. 9. The valve of claim 8, wherein each pair of adjacent side tabs extends radially outwardly The valve of claim 8, wherein each pair of adjacent side tabs extends radially outwardly

through aa corresponding through correspondingcommissure commissure window window formed formed by respective by respective side struts side struts of the of the window window

frame portion to frame portion to aa location location outside outside of ofthe theframe frameextending extending circumferentially circumferentially away fromone away from one another and along an exterior surface of the side struts. another and along an exterior surface of the side struts.

10. 10. The The valve valve of claim of claim 9, wherein 9, wherein the the plurality plurality of of axiallyextending axially extending window window frame frame portions portions

are are depressed radially inwardly depressed radially inwardly relative relativeto toportions portionsofof thetheframe frameextending extendingbetween between adjacent adjacent

windowframe window frame portions portions when when thethe valve valve is is inin theradially the radially collapsed collapsedconfiguration. configuration.

11. 11. The The valve valve of any of any one one of claims of claims 1 to110, to 10, wherein wherein an outer an outer diameter diameter of the of the inflow inflow end end

portion of the frame is smaller than an outer diameter of the outflow end portion of the frame. portion of the frame is smaller than an outer diameter of the outflow end portion of the frame.

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41 24 Jun 2025 2023208213 24 Jun 2025

12. 12. An assemblycomprising: An assembly comprising: aa delivery delivery apparatus apparatus comprising anelongated comprising an elongatedshaft; shaft; and and an implantable an implantable prosthetic prosthetic heart heart valve valve according according to any to oneany one of1 claims of claims 1 to 11, said to 11, said

prosthetic heart valve configured to be implanted in a patient’s body. prosthetic heart valve configured to be implanted in a patient's body. 2023208213

Edwards Lifesciences Corporation Edwards Lifesciences Corporation

Patent Patent Attorneys Attorneys for forthe theApplicant/Nominated Applicant/Nominated Person Person

SPRUSON SPRUSON && FERGUSON FERGUSON

AH26(46198026_1):BJM AH26(46198026_1):BJM