AU2015230876B2 - Medical devices with detachable pivotable jaws - Google Patents

Abstract

Medical systems, devices and methods are provided for engaging tissue, e.g. for clipping tissue, closing a perforation or performing hemostasis. Generally, the medical system including a housing, first and second jaws rotatable relative to the housing, a driver, and an elongate drive wire. The elongate drive wire may be disconnected from the driver, first and second jaws, and the housing, which are left in vivo engaged with the tissue. 352 357 358b 368 346

Description

ο (N α ω GO σ^ (Ν Ό Γ ΟΟ ο m (Ν Ο (Ν

DEVICES WITH ΡΕΤΑΟΗΑΒΙΕ PtVOTABLE jA^S

BACKGROUNO

Conventionally, a Glip oiay be introduced into a body cavity tbrougb an endoscQipa to grasp living tlssu© of a body cavity for bemosiasls, markiacf, aad/or ligating Such clips are often Known as surgical clips, epdoscopso ciips, barnosiasis clips and vascular clips, in addltlbn, clips are now being used in a nurnPer of applications related to Qaairoiniestlnai feieeding sue* as popic ulcers, yalfory-Weiss tears. Dieulafoy’s tesions. anglofnas, post-paplilotomy bieedlng, and small varices With active bieeding. Clips have also been attempted for use In closing perorations in the stomach |0bO2| Gastrointestinal bleeding is a vsomewhat common and serious condition that is often fatal If left iintreated. Ibis problem has prompted the development of a number of endoscopic therapeutic approaches to achieve hemostasis such as tie Injection of sclerosing agents and corftact therrno-coagulatiori techniques, Altbough such approaches are often effective, bleeding continues for many patients and coiTeetive surgeA<' iherefore becomes necessary. Because surgery is ah invasive technique that is associated with a high morbicsty rate and many other undesrable Side effects, there e.xtsts a need for highly effective, less invasive procedures.

Mechanical hefoostatic devices such as clips have been used in vahous the body, includihg: gastrointestinal applldalons. One of the problems associated With convehtional, hemostatic devices and ctips, howevef,: IS that many devices are not strong enough to cause permanent nemostasis. Further, clips have aiso been attempted for use in closing perforations in the stomach or gastrointestinal stmetures:, but unfortunately traditional clips-suffer from dilficuli placement and the oapabity to grasp a limited: amount of tissue, potentially resuftlng in incomplete; closure. ο (Ν Λ (D C0 σ^ (Ν οο ο m (Ν ΙΟ Ο (Ν ΙΟ

SUMMARY 100041 The invention oiey include any of the foliowing aspects In various comhinatlons and may also include any other aspect described below in the wfitien description or in fee attached drawings. 100051 in a fir's! aspeet, a medioal device is provided for engaging tissye, the medical device including; a housing, first and second Jaws, a |aw pin and a driver. The housing defines an Internal passageway and a iongltudlnal axis extending between proximal and distal ends of the housing. The housing aiso defines a Jaw guide surface along the Intenial passageway, the jaw guide surface having a distal end. The first and second jaws have a proximal end siidabiy and pivotally connected to the housing, and are siidabiy received within tbe internai passageway for longitudinal movement along the Jaw guide surtace between an exiended ppsitipn and a retracted position. The Jaw pin extends througb the proximal ends of both the first and second Jaws, and engages the jaw guide surface of the housing. The driver is engaged with the phjximal ends of the first and second Jaws, whereby iongitudinai movement of the driver moves the first and seoond Jaws iongitudinally aiong the Jaw guide surface between their retracted and exiended positions; Loogitudinai movement of the driver also rotates tim first and second jaws relative to the housing when the first and seoond jaws are In their extended positions, |0OO5| .According to more detailed aspects, the Jaw pin engages the distal end of the jaw guide surface when the first and second Jaws are In their extended positions; The proximal ends of the first and second jaws inPlyde gears havihg teelh, and the driver includes corresponding teeth fiiat mesh with the teeth of the Jews, The proximal ends of the first and second Jaws are formed as piniohs, and the driver Is formed ps a rack, whereby longiiudihaf movement of the driver and recb roiates the plniohs and first and second Jaws In their extended positions. The driver ihciudes a central spine exiending longltudinaliy and teeth extending in laterally oppcsite directions from the spine to form two sets of teeth, one of the two sets of teeth engaged with the pinion of the first jaw. fte other of the tves sets of teeth engaged with the pinidh of the second law. In; one embodimeht, the driver iricludes a central plate having first and second ends, and a first set of teeth extend laterally from the ο (Ν <D GO σ^ (Ν 00 ο m (Ν ΙΟ Ο (Ν ΙΟ first end of the cedtrat plate and a second set of teeth extend laterally froia the second end of the centrai plate, the iret and seoohd seta of teeth extending in iateraiiy opposite dfrections. central plate preferateiy extends in a plane parallel id the fohgitudihal axis, and may ihplude a slot extending through a distai end # the plate, the slot sized and positioned to receive the jaw pin, A cross-section of the centrai plate and sets of teeth, in a plane perpendlcifiar to lie longitudinal axis, fonhs a Z-shape. 100071 in a second aspect, a medical device is provided for engaging tissue, the medical device including a hoysing, first and second Jaws, a driver, and a drive wire. The housing defines an internai passageway and a iongitudinai axis exfonding between proximal and distal ends of the housing. The first arid second Jaws arO: rdtatabie relative to the housing, and have pFOximai and distal ends. The driver is engaged with the proxirhai ends of the first and second jaws, whereby longitudinal movement of the driver rotates the f rst and second |aws falative to the housing. The driver ihcludes two locking tabs forming a soclret ^eihg proxirnaliy, and is constructed of a material that plaStioaily deforms to adjust the size of the socket. The elongated diive wire is selectively oonnected to the dnver for longitudinal movemeni tearewith. The drive wire has an ehlarged portion proximate a di^al end of the drive wire and the socket receives the eniafged pofloh of the drive wire. I00OSJ According to more detailed aspects, proximal withdrawal of the enlarged poftlon from the socket causes the ddver to piastlcajly deform and the locl^ing tabs to move lateraify outwardly. The housing includes a guide surface guiding the iongitudinai movemeni of the driver, and the guide surface includes two surfaces on opposing sides of the housing corresponding to the two iocking tabS; The guide surfece also prefs^bly includes a proximal portion, a distai portion and a shoulder at the transition between of the proximal and distai portions. The shoulder faces proxirnaliy, vsteereby the locking tabs are positioned to engage the shoulder to limit iongitudinai rndvemenl of the driver after they have been moved lateraily outwardly by the ehiarged portion of the drive wire, 100001 in a third aspect, a medical device is provided for engaging tissue, the medical device ihciudihg a housing, first: and secohd jaws, a driver, a 3

ο (N pH <υ GO σ^ (N

00 o m (N in o (N and a drive wire, T;he housing defines an iniernal passageway and a iohgiiudina! axis extending baiween proximal and distal ends of the hpusing, The first and second jaws aire dalatabld: relative to the housing:, and have proximal and distal endS::. The dhVer ia engaged with the proximal ends of the first add second jaws, whereby iPngitudlnal movemeni of the driver rotates th:® first and second jaws relatiye to the housing. The biasing strip is operatively connacted to at least one of the first and seeond jaws to bias the jaws radially. The elongated drive wire is selectively connected to the driver for iongitudina! movement therewith, |OCtli| According to more detailed aspects, a first end of the biasing step engages the first jaw and a second end of the biasing strip ehgvages the second Jaw, A middle portion of the biasing strip is fixed to a distal end irf the driver and moves therewith. In another embodiment, the biasing strip Is a first biasing strip and the device also includes a second biasing sdip. The first biasing strip has one end fixed to the drst jaw and the other end slidabiy attaehed to the housing. Ukewlse, the second biasing strip has one end fixed to the second jaw and the other end slidabiy attached to the housing, Here, ah exterior of the hcusing inciudes first and second chahneis sized to receive the first and eecond biasing strips. The first and second biasing strips are fixed to the::distal ends Of the::firsi and second jaws, respectively.

:N OF

BRIEF DESCF

E DRAWINGS |d011| The accompanying drawings incorporated in and forming a part of the specificatibo luslrate severaf aspects of the present invention, and together with the description sa:rve to explain the principies of the invention, in the drawings· |0P12| FIG. 1 Is a top view of a medical system having a medical device for engaging tissue, constructed in accordance with the teachings ef the present invention; |0b13J FIG, 2 Is a: top view slmliar to FIG. 1, but shovcng the ouief siruclufes in dotted lines and me intorlpr sections in solid lines and partial cross seotion; 100141 FIG. 3 is a side view of the medicai system and device depicted in FIG, 1; |0O1f| FIG. 4 is a side view smiilar to FiG. 3, but showing the outer siruciures In dotted ilnes and me interior structures in solid lines and partial cross section ο (Ν α ω m σ^ (Ν οο ο m (Ν Η Ο (Ν ΙΟ 3. 5 ΐΙ a side view of a medical devid© that is part of the medical system depicted in FIGS. 1-4; |δδΐ ?| FIG. 6 is a front view of a housing forming a gortion of the medlcai syMem and deyloe deploted Id FIGS. 1--S; pcilSJ FIG; 7 ls a pemisective view of the housln#depicied in Fi<3. 6; poiS] FiGS. 8~12 are side views showiiig operation of the medical system and device depicted In FIGS. 1-5; |0δ20| FIGS, 13 and 14 are top views, partiaily in cross-section, depleting operation of the medical system and device depicted In FIGS. 1-4; |0O21| FIGS. 15 and 16 are eross-seoiiona! views showing operation of the medioal system and device depicted In FIGS, 1-4, 100121 FiGS. 17 and 18 are a perspective view of an aiterhaie embodiment of a grasping jaw forming a portion of the medical system and device of FIG, 1; p023J FIG. 19 Is a plan view of an ailernate embodiment of a driver terming a portion of the medicai system and deyice of FIG. 1; P024| FIG. 20 is a pefspective view of the driver of F!G. 19 shown attached to a drive wire; |002S| FIG. 21 is a side view of FIG; 20; |002S| FIG. 22a is a plar? view of an alternate embodiment of the medicai de^sce of FIG. 1, and FIG. 22b is a plan view of the dhver of F!G> 19 shown attached to a strip and forming a portion of the rnedfoal devioe of FIG. 22a: |0O27| FIG. 23 is a plane view of anotier alternate embodiment of the medicai device depicted in FIG, 1; ίδδ28| FIGS. 24 and 25 are a perspective views showing operation of the medicai device depicted In FIG; 23; |0P29| FIGS. 26 and 27 are perspective and end views, respectively, of ahother embodiment of a driver fontsing a portion of the medicai system and device depicted isl FIG. 1; |0036| FIG, 28 Is a perspective view of the dnvef of FIGS. 26-^26 shown altached ίο the 1¾ 5 ο (Ν Ρη ιη σ^ <Ν οο ο rn rs( Τ—I ο (Ν to 190313 FiGS. 29 and 30 am p!an views showing oderaiion of the driver and jaws dopieled in FIG, 2S; 1903¾ FIGS. 31 add 32 aia croes-sectional views of ahothar omOddimeht of the rriedioal sySiem add deviee depicted id FiG, 1; and |9033J FiG> 33 Is a perspective view of the fnedicai system arid device depicted in FiGS. 31 and 32.

DE-miLED DESCRiPTIQN |9034| The terms "proximal® and “distar’ as used herein are intended to have a reference point relative to the user. Specifically,: throughout: the specificatioh, the: terms "distaf and “distaily” shall denote a position, direction, or orientation that is generaliy away from the user, and the terms “pmximar and “proximaiiy’’ shall dehofe a position, direction, or orientation that Is geheraily towards the user I903II An exemplary medicai isysiem 20 dayihg d medicaf deyiee 40 for engaging tissue T (FIG, 11) is shoWh in FIGS:. 1 through 4, The medicai system 2:0 and device 40 are geheraily si2ed and structijred for Oiperatioh through the working channei of an ehdoseoipe (not showh) or other scope, although the system 2Θ and device 40 may also he used alone or in conjunction with other elongate devices such as oatheters, fiher-optic visualization systems, needles and the like, Genera!iy. the medical system 20 inciudss a drive wire 22 sildahiy housed within the distai end 23 of an eiongated catheter 24 for selective connection to, and operation of, the medicai device 40, As wili he described in fofther detail herein, the medioa! device 40 generally includes a housing 42 having a flrsi Jaw 44 and a second jaw 46 pivotally connected thereto for engaging the tissue T Generaliy, the Jaws 44, 40 have been shown as forming grasping forceps, aithough the Jaws are intended to be used to cilp tissue, e.g, to oiGse an opehing or for hemostasis. Accordingly, it will be recognized that the shape and structure of the jaws may take many forms and serve many purposes and fohrXions^ ail in accordance with the teachings of the present invention. |993S| Ih the medical system 20, the drive wire 22 siidabiy extends through the ;oafoeter 24. Aithough the term “yllre” is used to refer to the drive wifo 22, it wl he

ο (N Qh Ό m σ^ (N

r-- oo o m (N in O (N that ainy elongate control member capafeie^ of transmitting jongilMdinal force over a distance (such as Is required in typical endoseopld, laparoscopie and similar prdeeduraa) rnay be used, and tnis Includes plastic rods on lubes, slngla: filament or muiti-^lament wires, metal rods and the like. Tbe drive wire 22 sbculd also be capable of properly transmitting a rotatlonal/toraional force from tbe proximal end to the distal er^d fo rotate the medicaj device 40 and Jaws 44, 4S, and thus It Is currently prefemed tbat the drive wire 22 is formed from nitinol (e.g, a nftinol wire) or other superelastic alloy, A connection block 26 is slidably fitted within the distal end 23 of the catheter 24 and defines a bore 28 therethrough whioh slidably receives the dfive wire 22. The exterior of the r^nnectlon block 26 Includes a recessed portion 27, and two pins 30 (e.g., formed from stainless steel wire) are connecied to the catheter 24 and positioned within the recessed portion 27 to limit the longitudinal movement of the cohneeiion block 26.

[0037] A distal end of the drive wife 22 defines a distal head 32 fiat is sized larger ihan the dhve wire 22, and likewise jarger than the bore 28 In the conneciion block 28, As will be descnbed later herajn, the distal head 32 Is used to slide the connection block 28 within the catheter 24 to disconnecl: the medical device 40 from the medical system 20. As also seen in FIGS. 1-4, the housing 42; of the medical device 40 is a tubular member defining an intehor space 43. A proximal end of the housing 42 frictlonaliy receives a distal end of the cdnheetion block 28 within the Interior space 43 for selective connecticn ihei'ewiih. |0O38| The internal passageway 43 of the housing 42 also receives the first and second Jaws 44, 48 and a driver 48 which is used to Interaonnect the drive wire 22 to the Jaws 44, 46. As best seen In FIGS. 1, 2 and 5, the driver 48 has a iproximai portion which defines a socket SO sized to receive enlarged distal head 32 of the drive wire 22, At the proximal entrance of the socket 60, two deHectable locking tabs 52 are formed which rotate re;iative to the remainder of the driver 48 to increase or decfease the size of the socket 50. The locking tabs §2 may be separately formed and pivotally attached to the driver 48, or may be integrally formed with the driver 48 and fonned of a resilient maiertal which flexes to permt rataifon of the locking tabs 52 radially iriwardiy and radially outwardly, A distal portion of the driver 48 defines a

Ο (N α (D GO σ^ (N

(X) o m (N in O (N rack 54 for engaf ing and dpersling the Jaws 44, 46. in the depicteil embodiment, the rack 54 includes a oehtrat Spine 56 haying teeth 56 pi^^scting away 5Om the ceidrai spine 56 and on opposite sides of the spine 56, One set of teeth 58 on one side of the spine 56 generaiiy operate the fitst Jaw 44 while the other set of teeth 58 on the other side of the spine 56 operate the second Jaw 46, It wi!t be recognised that the rack 54 may Inciude a singie set of tesith or other geared stryotures that interface with the Jaws 44, 46, |603S| As best seen in FIG. 5, the first and second jaws 44, 46 include dista! ends 60, 62 that are structured to grasp and engage tissue, generaiiy they have a talon shape as disciosed in 61/141,934 fifed Deoember 31, 2906, the disoiosufo of which is incorporafod herein by reference In its entifoty. The proximal ends 64, 66 of the first and second Jaw's 44, 48 each inciude a pinion gear 68, 70 having a senes of teeth. The teeth of the pinion 66, 70 mesh with the teeth of the rack 54 of the dri ver 48 sueh that fongitudinai transiation of the driver 48 induces iPtatioh in the first and second Jaws 44, 46 feiative to one another, Generaiiy, distai transiation of the dhver 48 Gauses the first and second jaws 44, 46 to rotate outwardiy away from each ether, while proximal retraction of the driver 48 causes the first and second jaws 44, 46 tO: rotate Inwardly toward one another. Pins 60 are fiped thorough each the; piroximai ends of the Jaws 44, 46, to pivotally connect the jaws to the housihg 42, Other structures for forming a pivotal conheclion may be used,, arid preferably the pivotai connection is centrally arranged miaiive to the plnlonS: 66, 70. |δδ46| In addition to the jaws 44, 46 being pivotally atlaohed to the housing 42, the first and second jaws 44, 48 are also slidably attached to the housing 42. As best seen In FiGS; 6 and 7 (and in cotijunction wih F!GS 1-4) the housing 42 defines a first guide surface 82 for foe limt Jaw 44, and a second guide sufface 84 for the second jaw 46, As seen In FIG. 3, the first and second guide surfaces 82, 84 are formed by elongated slots 82a, 82b, 84a, 84b formed in opposing sides of the hbiising 42 which leaves a thickness of the housing 42 exposed to serve as the gdide surface. The slots 82a, 82b are aligned to receive the conrtcctingipjn 80 pf the: first jaw 44, bnd likewise the sibtS 84a, 84b are aligned to receive the connecing pin 80 of the second jaw 46. The ends of the siofo, for example distal ends 92, 94

ο (N 5¾ (ϋ GO σ^ (N Ό Γ ΟΟ ο m (Ν in Ο (Ν ^hown in FlO. 7, serve to restrict tlie iongitydinii rnovenient of the jaws 44, 48 mtative to the housing 42, Tha proximai ends 84, 68 Of the jaws 44, 46 include apartures:: 72, 74 which receive:: the pins 80 (F|C»B. 1,: ,2" and 3) that are used to sildabi^f: ahd pivotally connect the first and second jaws 44. 46 to the hdusihg 42. |8P41] it can also be seen In FiOS, 6 and 7 that the housing 42 defines a third guide suffac© 88 which guides the longiludlnal move:ment of the driver 48 within the housing 42, The guide surface: 86 in the depicted: embodiment inciudes a left guide surface 66a and a right guide surface 86b formed as C~shaped channels. As shown in FiG. 7, th:e third guide surface 86 fransitions from a smalier proxifnal width to a larger distal width to define a shoulder 88 at the transition, vdiich Wifi be further described hereiribelow with reference to FIGS. 13 and 14, 100421 As aiso shown In FIG:. 6, the interna! passageway 43 of the housing 42 extends tirough the distal end of the housing, and through whioh the first and second Jaws 44, 46 can extend, AdditiOnaliy. as shown in FIGS: 1 and 2, the housing 42 defines opposing slots 45 which are sized to permit the first add second jaws 44, 46 to pass therethrough when they rotate radiaiiy putwardiy. Accordingly, it is also dearfiom FIGS, 1 and 2 that the housing 42 serves to block roiation of the first and second jaws 44, 46 when toey are ahtlfely or partially contained within the Ihtorhal passageway 4$ of the housing 42. Suitable plastics for torrhlhg the housing ihclpde, but are not iimited to, poiytetfaffuorethylene {PTFE), expanded polytetfafluoretoyiene (EPTFE), polyethylene ether keytone (PEEK), polyvinylchloride (PV€), poiycatoonate (PC), polyamide, polyimide, polyureihane, polyethylene (high, medium or low density), and suliable metals indude stainless steel, nltlnol and similar medical grade metals and alloys, |9043| Operation of the medical device 48 will now be described with reference to FIGS. S~12, As shown in FIB. 8, the first and second jaws 44, 46 are shown in a retracted: position where they are supstantially contaihed within the housing 42, Depending on the applicatipni the distal ends 60, 62 of the jaws 44, 46 may slightiy p:rpiect 1fom the distal end of the housing 42 in their redacted positions, or they may be entirely positioned within· the housing 42. When the: drive wire 22 is trahslated distally (to the right on the page in FiG, 8) the distal bead 32 engages the driver 46, ο (N α ω m σ^ (Ν 00 ο m (Ν Ο (Ν the driver 48 arid jaws 44, 46; sisde disially through iha housing 42. The driver 48 and 44. 48 slide longifedinaliy befcre they rotate (even though the rack 54 of drivan 48 is meshed with the pinions 68, 70 at me proxirnahends 64, 60 of the I, 46) since the resistence to iongitudinai friovement is less than the ferce Id rotaie the jaws 44, 46 (alternatively, the hoysifig 42 can bteck rotation of the jaws 44, 46 when they are within the housing 42). As previously mentioned, this iongitydinai movement is guided by the first and second guide surfaces 82, 84 which receive the pins 80 that sildably and pivotaiiy oonnect the jaws 44, 46 to the

As Shown in FIG, i, the first and seccnd jaws 44, 46 have an extended position where me jaws substantiaiiy project from a distal end of the housing 42, and their proximai ends 64, 66 are positioned adj;acent the distal end of the housing 42. Acoordingiy, it wifi be seen that further distal advancement of drive wire 22, and hence the driver 48, causes the pinion 68 to rotate over the teeth S8 of the rack 54. As best seen in FiG. 10, the first and second jaws 44, 46 rotate radially outwardly from each other into a tissue receiving position, Notahly, due to the presence of slots 45 at the dista! end of the housing 42, me Jaws 44.46 are permitted to rotate a lull Θ0®, thus forming at least a 180® between them, it wili be recognized that through me sizing of the siots 45 and the constructioh of the rack 54 and pioidris 68, 70, the first and second jaws 44,46 may rotate even furthw away from each other, ρό45] in the tissue receiving configuration shown In FiG, 10, the medical device 40 and its jaws 44, 46 may be positioned adjacertt tissue T. As shown In FIG, 11, the tissue T may be placed between the frst and second jaws 44, 48 and the jaws 44. 46 rotated back iowards their position showm in FIG 9. The tbssue T has been shown as a single layer, although multiple layers may be Gllpped between the Jaws 44, 46. Generally, proximal retraction of the drive wire 22 and the driver 48 again causes rotation of the first and second Jaws 44, 46 to grasp the tissue T therebetween. As shown in FIG, 12, mrther proxirnal mlraotion of the drive wire 22 and dnvef 48 will cause the jaws 44,46 to move iongitudiilally in a proximal direction (to tha left on the page in BG, 12). 10

Ο (N Λ (D GO σ^ (N

00 o m (N in o (N in |;0δ4β] !n order for t^e oiedicai devioe 40 Ιό sedie as a clip and maintaio its grasp on the iisstid T, or to maintain tPe clipping of &amp;ν© laprs of tissyo against each otPep the jaws 44, 46 may be locked in position arid the dtive wire 22 of die medical systarn 20 disconnected from the medical device 40, As shown in Fie, 13, the third guide suflace 86 (which guides the driver 48) includes a proxlma! portion 86p and a distal portion 86d, The proximal portion 86p of the diird guide surface 86 has: a width (rneas:ured up and dowrt on the page in FIG, 13) that Is greater than a width of the distal portion 86d of the third guide 86, As previousiy discussed, the third guide: surface 86 is formed Py opposing surfaces or C-shaped channels 86a, 86:b of the housing 4:2. The transition Oetween the proxima! portion 86p and distal portion 8Sd defines a shouider 88, and hamely two shouidefs 88a, 88b on opposingisides of the housing 42> The shoulders 88a, 8813 are sized and positioned to engage the locking tabs 52 located on the driver 48. |O047J As shown in FIG. 13, when the driver 48 is iodated within the disfaTportion 86d of the third guide surface 86, the ldcking tabs 52 are forced radleiiy inwardly into fimiifictionai engagement with the drive wire 22, Stated anoth^ way, the socket SO formed by the driver 48 to reoaive the disiai head 32 has an eMrance vWsich is harrowed by the inward defiection Of the iocNing tabs 52. Proforably, tie locking tabs 52 plastically defOfUi faiher than eiastlcaiiy defohil, and the tabs 52 rnay be bent inwardly around the distal head 32 during initial assembly of the device, and thus sized for the disiai portion S6d of the ίΟΐιχΙ guide surface 86: In this state depicted in FIG. 13, the drive wire 22 is firmly engaged with the driver 48 and hence the first and second jaws 44,46, |0648] When the drive wire 22 and driver 48 ate reh'acted proximally, for example upon grasping tissue as shewn In FIG, 12, the proximal end of the driver 48 Is received Within the proximal portion 86p of the third guide surface 86 which has a larger width that permits radially outward movement of the locking tabs 52, .Accordingly, In the state depicted in FIG, 14. the looking tabs S2 may be loosely arid detacHably connected: to the distal head 32 of the drive wire: 22, That iSj the: proximal retraction cl the jaws 44, 46 will be limited by either ihe· tissue T eiigegjhg the disiai: end of the h:0usi:ng 42, or the pins 80 will: abut The iproxlmal ends of the 11

ο (N <D OO σ^ (N

00 o m (N O (N slots jB2a, 82b, B4a, 84b dofinlng a first^d seoond guide Suilbces 82, 84, As such, wbeb pfOxImal movement of the jaws 44, 46 and the driver 48 are thus jimited, further prcxKimal movement of the drive wim 22 and Its distal head 32 may be used to withdraw the distal head 32 from the socket 50 of the driver 48. This operatidn may aiso be used to further defiect the locking tabs 52 radially outwardly: An appropriate amount of disfaliy directed force on die drive wire 22 causes the distal head 32 to move proximaity through the locking tabs 52 and plasticafiy deform them radially outwardly. In the event the naturai elasticity of: the tissue T tends to pull the jaws 44, 48 out from the housing towards their exteihded poslilo:rl, the looking tabs 52, 54 will abut the shodlders S8a, 88b of the third guide surface of the housing 42 to pmvent further distal movement of the jaws 44,46. pe4S| Turning now to FIGS. 15 and 16; upon stili furthef proximal netraotibn of the drive wire 22 and distal head 32, the enlarged distai head 32 will aput the connection block 26 which is slidabiy fitted within the distal end 23 of the catheier 24: Soffidient proximal force on the dnve wire 22 wiii overoome the fridtional fit between the ophnection block 26 and t:he proximal end of the housing 42, thus movingthe conn ectibri block :26 pro:xim:aiiy Cto the right on the page of FIGS. 15 and 16) to retract the conhectioh blook 26 iwithih tha tubular oonnecidf 24, aS: shown in FIG, 18. The catheter 24 dan be used IP provide a couhterfOica:0h the housing 42 while proximaiiy retracting the dhve wire: 22 and cohhectibn block 26: Accordingly, the drive wire 22, catheter 24 end connection block 28 may be fully disconnected from the medical device 40, thereby leaving the first and second Jaws 44, 46 and the housing 42 In a state having the tissue T :ciipped between the jaws 44, 46 and retained in vivo. The: connection block 26 is retained at the disla! end 24 of the catheter 24 via the pins 30, which are positioned within the recessed area 27 to engage the proxlma! and distai ends of the oonnectlon block 26 and limit Its iengitudine! movement.

[δδδΟ] The elongated cathafer 24 for other elongate tubuisf member such as: a sheath, tube,: scope or the like), which slidably enoases the dnya wire 22, extends pfoximaily thereaiong to a pfoximai end pf the system 20, and has a length suitable fdr piacihg the device 40 at ahy desired loeatioh within the body, while the proximal 12

ο (N Ph <D GO σ^ (N

O 00 o m (N in o (N in ends of drive wire 22 and caiheter 24 are positioned ouiside of the body for use by the medieai professional, Coniro! handles (not shown) for controliing relative transiedoh of the drive wire 22 and catheter 24 are weli ^ndwh In the ait, an d may be empoyed at the proximat end of the system 20. PS61J Another embodiment and method of forming the grasping Jaws 44, 46 are shown In FIGS. 17-18. The Jaws of the prior emfeodiment were ganeraiy machined^ however the jaws 44, 46 may also be formed by stamping, A flat piece of metai preferabiy of medical grade stainiess sieei, is stamped into the shape 144 shown In FK5,17> The shape inciudes a siightiy narrow distai end 16D wtiich then can be bent into the shape shovm in FiG. 18 fcr grasping and engaging iissue. The distai end 16Q may aiso be stamped to inciude a serrated edge, or other shapes or edge features depending upon the application. The prbxima! end 164 generaiiy Inciudes two arms 166 which Jead to gears 168. As shown in FIG. 16, tie gears 168 are grasped and then rotated about 90 degrees such that the gears IBS extend in a plane that is perpohdicuiar to the plane of the sheet 144, The gears 168 also inciude a inrougn-hole 172 for receiving a guiding pin. it wilt also be recognized thai the jaws 44, 46 in this embodiment may aiso be lorrned of a single arm 166 and singia gear 168. |0862| Another embodiment of a driver 148 and drive wire 122 are shown in FIGS. 19-22. The driver 148 generally includes a socket I SO termed by two jocking tabs 152. In this embodiment, a proximal portion of the iooking tabs define slanted shoulders 164 which slope laterally outwardly for engagement with the third guide sufface 86 in the housing 42 as previousiy discussed. The iocking tabs iS2 also inciude inner projections 153 whioh project iateraHy inwardly and separate the sooket 150 into a distal portion 150d end a proximal portion 1S6p. The dnvar 146 again includes a central spine 156 and opposing teeth 15S. In this embodiment, the gistal end 166 of the ddver 148 includes a pocket 168 definad by two inwardly pro|ecting flanges 17Q, as will be discussed further herein, The tWc flanges 170 extend along a distal side of tha:pocket 168, and leave a gap therabeiweah for access to the pocketl 168. 13:

Ο (N α (D GO σ^ (N

Ό Γ ΟΟ ο m (N O (N

1 K.O nsre^ are |Ιϊβδ3| As seen in FIGS. 20 and 21, tnls embodiment of tOe dnve wire 122 includes a idlsial head: 132 which is fohried by faendinglih of fha drive wire 122 inlO: a: serni-cifGolar shape as shov«i, pnelarably epannlhb an arc of degrees to 300 degrees, According!y, it can be se:en that the: d:isi:al head defines an dpenifig 133 that Is sized to;: receive the Inner projections 153 of the locking tabs 152, As shown , the dlstaj portion tSOd of the socket I SO receives the distai-most pari of the curved distal head 132, while the proximai portion of the distal 132 prefects throygh the proximal po:r1lon 150p of the socket 150 and away therefrom, As noted above, the locking tabs structured to fee plasticaiiy ddformod, and thus after formation and connection to fee drive wire 122 as shown in FIG, 19,: the tabs 152 are feent radiaily: inwardly to secure the prqleciiohs 153 vvlthin the opening 133 of the socket 132. in this state, the extenor shoulders 154 of the locking tabs 152 are sized to fit vvlthin the third guide surface 86, and more ipadidalarty the disfal portion 86d of the third guide surface 86 without birth er defo:rmati:dh, |O064| AS Shown in FIGS, 22a and 22b, another embodiment of the medical device 140 may incjude the bousing 142, grasping arms 144,146 just as in the prior emfeodimeni, but in this embodiment include the alternate driver 148 and an additiprial biasing eiement, namely a biasing strip 190. As best seen In FIG. 22b, the dlstai end 166 of the driver 148 receives the biasing strip 190 within the pocket 168, The Ganges 170 are beni inwardly and pFOKimally as shown to firmly engage the metal strip 190 and fix itto the driver 148, The biasing strip 190 is preferably a thin sblp formed from a sheet of resiiient material, and more preferabjy a metal strip, e.g, formed of sfainiess steel, hitinol or other super elastic alloy that is bidcompaibie. Accordingly, It will be recognized that as the driver 148 Is moved proximaily to cause the Jaws 144, 146 to close, the feiasihg strip 190: will be forced !:nto a \Ashape or U-shape, as shown fey the dotted lines i:ri F:iG, 22a, That Is, the biasing strip 190 has a straight shape in Its natural, uribiasad, configuration, and when bent into the V-shape it exerts a radially feuiward force on the Jaws 144,146. This biasing force provides the jaws 144, 146 with smooth rotation and transition between the open and ciosed positions. It will also be recognized that the biasir^ 14 ο (Ν a (D ιπ σ^ (Ν Ό Γ ΟΟ ο m (Ν ιη Ο (Ν

Mrip 1§δ could also have its origiilal unbiased position toFnied as a V-shape or a U-shape, and be aitixsd lo the Jaws 144, 146 such diat i exerts a radially Inward biasing force. The free ends 192 of the metal strip 190 simpiy press agalest the Jaws 44, 46, but are not fixed or ngidly attached Iheretoj |00S§| Turning to FIG: 23, another embodiment of the medical device 240 is shown^ again including a housing 242 and oppostn| Jaws 244, 246 that are slidably attached thereto. The housing 242 again includes first and second guides 262, 284 for guiding movement of the jaws 244, 246, in this embodiment however, each Jaw 244i 240 Includes a biasing strip 290a, 290b, respectively. The distal ends 291 of strips 290a, :290b are fixedly attached to the exterior Of the Jaws 244, 246. ly at their distal ends, and preferably by way of an adhesive, soldering, welding, or other known bonding techniques. As best seen in FiGS. 24 and 25, the hdusing 240 inoludes two extedor chan neis 294 on opposite sides of the housing 240 (dna being Shown in FIGS, 24 and 25) which are sized to raceive ttie resilient strips 290a, 290b sudh that they are flush with the extedpr surface of the housing In the dosed/retracted bonfiguration. The proximai ends 293 of the strips 2S0a, 290b include a T-shaped forrned by a base 295 and cross bar 296. The base 295 extends throygh a smaiter slot 296 formed through the housing 24Θ. The slots 296 are Pbe>ddhsive AVith the channels 294. The cross bar 2¾ rides along the Ihtenor of the housing 240 and maintains the slidable connectfon between the strips 290 and the housing 240. Aceordlngly, It can be seen that the proximal ends 293 of the sbips 290a, 29Pb are slidably and pivotably attached to the housing 24Q via the channel 294 and Its slot 296, allowing the strips 290a, 290b to travel with the grasping Jaws 44, 46 as shown between their open and closed positions as shown in FIGS , 24 an |90SS| Turning now to FIGS. 26-30, another embodiment of a driver 348 is shown, As best seen in FiGS. 26 and 27, the dnver 348 again Includes a socket 350 fonned by two locking tabs 352 which have inner objections 353 and outer shoulders 354, and which divide the socket 350 into a dlstai porfion 353 and a proximal portion 350p. Unlike the prior ernbodlments of the driver, in this embodiment the distal portion defines a geared rack that has a Z-shape. Generally, 15 ο (Ν Ρη <υ ιη σ^ (Ν 'sD Γ ΟΟ ο m (Ν ιη Ο (Ν a central plate 356 irepfeces the cePtra! spine 56. 156 of'tPe prior ernpodiitients. and the piate 356 extends in a plane that is parailel to the longitudinal plane Of die hoy slog 342: (F|Q. 20). The piane of theiCOnd'ai plate 3S6 Is aiso ρβφοπΟϊοϋΙΐΓ to a plaiie Of the pfoxiitiej heif of the driver :348 (re. that which inciudes the socket 350 and tafes 352). A first set Of teeth 358a project iateraliy away from the eentral plate 356 in a first direction, white a second set of teeth 358b projeci lataraily away from the central plate 356 In a second direction. The first and second sets of teach 3S8a, 3580 extend from opposite ends of the central plate 356. and the first and second directions are generaliy opposite each other. The sets of teeth 358a, 358b are^ each securely held to the central piaie 356 by two outer frames 360 which extend around the periphery of the teeth 358a. 358b. |00S7| Accordingiy, and as best seen in Fii3:. 28, the medloai device 340 includes first and second grasping jaws 344, 346 each haying a proximal end 366 and gear teeth 388 which have been bent to projeOt orthogdhaily away from a main body of the law 344, Accordingly, the hrst set of teeth :358a receive the gear 368 ¢4 the eeccnd law 346, while the second set of teeth 358b receive the gear 368 of the first Jaw 344. Notably, having the proximal ends 366 of die Jaws 344, 346 bent lateraily/orthogohalty as shown allows a single pin 380 to be passed through tie gears 368: and thus shared by both jaws 344. 346. Still further, and as shown In FIG, 29, the housing 342 may thus Inciude only a single guide surface 382 formed by a singie slot on each laterai side of the housing 342 for receiving the ends of the single pin 380. it can be seen th:at the first and second jaws 344, 346 thereby share a singie guide surface 382 (a Jaw guide surface) and guide slot, thus ensuring their coordinated operaiion and Smooth opening and closing. |068S| As aisc shown in FIG. 29, a siot 357 Is formed in the central plate 356; and Is aligned with the pin 380 and Jaw guide surfaee 382 to receive the pin 380 as the driver 348 moves forwardly relative to the Jaws 344, 346, As discussed above and shown in FIG. 30, When the pin 386 (shared by proximal ends 368 and gOars 368 of the Jaws 344:, 346) has hit the distai end of the single jaw guide surface 382, the driver 348 will gontlPMe moving dlstaliy to cause the gears 368 to rotate via the 16 ο (Ν ω C0 σ^ (Ν οο ο m <Ν ΙΟ Ο (Ν ΙΟ rack/teeth 358a, 358b of the driver 348, tbemby inducing miation qf the 344, 346, |O0S0| Turning to FIGS- 31-33, another ernbodiineht of fee medicai system 420 and medioal device 440 are depicted, in this embodiment, rhedicai : system 420 again includes a drive wire 422 having a distal head 432 which is formed by bending the dista! end of the drive wire 422 into the shape shown. The medical system 420 also includes a catheter attachment 43Q which is :genera!iy a tubuiar member that is connected to the distai end of the catheter 24 and is used to siidabiy receive die connection biock; 426> The catheter attachment 430 includes a pair cT openings 434 to provide access to the contro! wire 422 and the connection biook 426, wbereby a toot may be used to hold the connection bioc^ 426 in either a retracted or e>itended position, as further described in cqpending U.S. AppI, No. 61/391,873 filed concurrently herewith, and Appl. No. 61/391,875 filed ccncuirentiy herewith, the dlsolosures of which are hereby Inedrpofaled by reference in dieir entirety. |806i| The medlcai device 44Q includes a housing 442 which is detachably oonneoted to the catheter 24 and Its catheter attachment 430 via the connection blocSi 426, The housing 442 siidabiy mceives the pair of Jaws 444 wbisti are connected to the drive wire 422 via die driver 448. As with the previous ernbodirrients, the driver 446 includes a socket 450 defined by locking tabs 452 which releasably engage ihe distal head 432 of the drive wire 422. The distai portion of the driver 448 includes a pfurailty of teeth 468 which dedne a gear or rack which serves to drive rotation of the: jaws 444 as previousiy descnbed. The: distal end 466 of the driver 448 includes a pocket defined by flanges which are used to fixabiy engage the biasing strip 490, The housing 442 further defines a pair of gyiding surfaces or siois 482 which guide the iongitodinal and rotationa! movement of the jaws 444. p081J In this embodiment, the jaws 444 and housing 442 are structured such that in the fuily retracted position (shewbT the jaws 44 project (at ieast partiaily) out distaly frorn the end of the hoysihg442. As bestaeeri In FIG. 32, as the-clistal head: is pushed through the locking tabs 452 trey are piasticaliy deforrhe outwardly toe shoufdem 446 In the housing, and the jaws 444; are fully retracted. Ih

ο CN pH (ϋ CO ON (N

NO 00 o rn (N T—( O <N iss way, the length of the housing 442 can he shortened, as can the guiding slots 482 therein for guiding the jaws 444^ It can also be seen in Fi9. 32 that the distal ends of the Jaws 444 include serrations 445 or other ssnctores which may aid in Qhgijing tissue, |δδΐ2| it is also noted that in this enibddihient, as with ali phoF embediments, the drive were 422 is capable of iransmitting rotational force and torgue |e,g. from the proxiniai opereting end of the system 20/420) through the distaihead 432 and tte driver 448 to the jaws 444, As such the medical device 440 may be abated via rotation of the drive wire 422, i.e. the jaws 444, jaw pins (e.g, 80), housing 442, and driver 448 al! rotate as a unit reiative to the catheter 24. Inasmuch as the housing 442 may also be non-rotatably connecied to the conhectlen block 426 (e,g, depehdirig on the friction therebetween), the conhecion block 426 may also rotate within the catheter attaohmeht 430 (or the catheter, e.g, 24) when the catheter attachment 480 is hot used. Accordingly, the orientation of the Jaws 444 may be rotated through rotation of the proximal end of the drive wire 422 to ohent the jaws relative to the tissue or material beirig grasped or dipped, it has been fr)und that: tdiming the drive wire 422 out of a Solid hitiriol wire has previded good torgue transmission for rotation of: the· rbedicai device |00S3| It has also been tburid ihat havihg the Jaws 444 project at least partially out cl the housing 442 in their fully retracted position aliows the orientaiion of the jaws 444 to be visuailzed so that it Is easier to rotate Jie Jaws 444 prior to opening and dosing them around tissue. Still further, additional issue may be ehcapsuiated in the jaws 444 before the tissue abuts the distal end of the housing 442, The disiance which the Jaws 444 prcject bem the housing 442 may be varied depending upon a particuiar application, i,e. sided to correspond to the thickness of the tissue or the type of procedure being formed to irisure good spacing betwieen the distai ends of the jaws 444 and the distai end of the housing 442. |0084] The foregcing description of various embcdiments of the invention has been preserited for purposes of illustration and description, it is not ihfended to be exhaustive Of to jimit the invention to the precise ernbodimehts disclosed. Numerous modifioatiohs or variations are possible ih light of the above teachings. 18

ο (N α CD m σ^ (N oc o m (N in in

O (N

The erabodsmenis discussed «®re chosen and described to provide tde best illusliiation of the pdneipies of the inveo^on and its praciloal application to ihemby anaOie one of drdihafy skill in; the ail to utilize the invention in various embodlnients and with various modificatlGns as are suited tb the particular use Gontenlplated;, All such modificatlohs and variations are within the scope of the Invention as determined tee appended oiaims vsteen interpreted in accordance with the breadth to which they are fairiy, legally, and equitably eniitled.

Claims (20)

1. A medical device for engaging tissue, the medical system comprising: a housing defining an internal passageway and a longitudinal axis extending between proximal and distal ends of the housing, the internal passageway defined by an inner surface; a first jaw rotatable relative to the housing, the first jaw having proximal and distal ends; a second jaw rotatable relative to the housing, the second jaw having proximal and distal ends; a driver engaged with the proximal ends of the first and second jaws, longitudinal movement of the driver rotating the first and second jaws relative to the housing, the driver including two locking tabs forming a socket facing proximally; an elongated drive wire selectively connected to the driver for longitudinal movement therewith, the socket of the driver receiving the distal end of the drive wire; and the inner surface of the internal passageway guiding longitudinal movement of the driver, the inner surface including a proximal portion and a distal portion, the distal portion having a width smaller than the proximal portion, the distal portion sized to press the locking tabs into engagement with the drive wire.

2. The medical device of claim 1, wherein the locking tabs are firmly pressed into frictional engagement with the drive wire.

3. The medical device of claim 1, wherein the driver is constructed of a material that plastically deforms to adjust the size of the socket, and wherein proximal withdrawal of the enlarged portion from the socket causes the driver to plastically deform and the locking tabs to move laterally outwardly.

4. The medical device of claim 1, wherein the inner surface includes two surfaces on opposing sides of the housing corresponding to the two locking tabs.

5. The medical device of claim 1, wherein the distal end of the drive wire defines an enlarged distal head.

6. The medical device of claim 6, wherein the guide surface includes a shoulder at the transition between of the proximal and distal portions, the shoulder facing proximally, and wherein the locking tabs are positioned to engage the shoulder to limit longitudinal movement of the driver after they have been moved laterally outwardly by the enlarged portion of the drive wire.

7. The medical device of claim 1, wherein the drive wire, driver, housing and first and second jaws are connected together such that rotation of the drive wire induces rotation of the driver, housing and first and second jaws together as a unit.

8. The medical device of claim 1, wherein the proximal ends of the first and second jaws include gears having teeth, and wherein the driver includes corresponding teeth that mesh with the teeth of the jaws.

9. The medical device of claim 8, wherein the proximal ends of the first and second jaws are formed as pinions, and wherein the driver is formed as a rack, wherein longitudinal movement of the driver and rack rotates the pinions and first and second jaws in their extended positions.

10. The medical device of claim 1, wherein the driver includes a central spine extending longitudinally and teeth extending in laterally opposite directions from the spine to form two sets of teeth, one of the two sets of teeth engaged with the pinion of the first jaw, the other of the two sets of teeth engaged with the pinion of the second jaw.

11. The medical device of claim 10, wherein the first and second sets of teeth each include a frame extending around the teeth.

12. A medical device for engaging tissue, the medical system comprising: a housing defining an internal passageway and a longitudinal axis extending between proximal and distal ends of the housing; a first jaw rotatable relative to the housing, the first jaw having proximal and distal ends; a second jaw rotatable relative to the housing, the second jaw having proximal and distal ends; a driver engaged with the proximal ends of the first and second jaws, longitudinal movement of the driver rotating the first and second jaws relative to the housing; a biasing strip operatively connected to at least one of the first and second jaws to bias the jaws radially, the biasing strip directly attached to the driver for movement therewith; and an elongated drive wire selectively connected to the driver for longitudinal movement therewith.

13. The medical device of claim 12, wherein the distal end of the driver includes at least one flange defining a pocket, the pocket receiving the biasing strip, the flange firmly engaging the biasing strip.

14. The medical device of claim 12, wherein the biasing strip is fixed to the driver.

15. The medical device of claim 12, wherein a first end of the biasing strip engages the first jaw and a second end of the biasing strip engages the second jaw.

16. The medical device of claim 12, wherein the biasing strip is a first biasing strip and further comprising a second biasing strip, the first biasing strip having one end fixed to the first jaw and the other end slidably attached to the housing, the second biasing strip having one end fixed to the second jaw and the other end slidably attached to the housing.

17. The medical device of claim 16, wherein an exterior of the housing includes first and second channels sized to receive the first and second biasing strips.

18. The medical device of claim 16, wherein the first and second biasing strips are fixed to the distal ends of the first and second jaws, respectively.

19. The medical device of claim 12, wherein the proximal ends of the first and second jaws include gears having teeth, and wherein the driver includes corresponding teeth that mesh with the teeth of the jaws.

20. The medical device of claim 19, wherein the proximal ends of the first and second jaws are formed as pinions, and wherein the driver is formed as a rack, wherein longitudinal movement of the driver and rack rotates the pinions and first and second jaws in their extended positions.