AU2015224527B2 - Stentless support structure - Google Patents

Abstract

A stentless support structure capable of being at least partly assembled in situ, and method for assembly in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Description

STENTLESS SUPPORT STRUCTURE 2015224527 11 Sep 2015 [0001] The entire disclosure in the complete specification of our Australian Patent Application No, 2013213684 is by this cross-reference incorporated into the present specification.

BAOKSRQUNB ©F THE INVENTION

[0001a] The discussion of documents; acts, materials, devices, articles and the like is included in this specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters formed pad Of the prior aft base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

[0002] There has been a significant movement toward developing and performing cardiovascular surgeries using a percutaneous approach. Through the use of one or more catheters that are introduced through; for example, the femora! artery, tools and devices can be delivered to a desired area in the cardiovascular system to perform many number of complicated procedures that normally otherwise require an invasive surgical procedure. Such approaches greatly reduce the trauma endured by the patient and can significantly reduce recovery periods. The percutaneous approach is particularly attractive as an alternative to performing open-heart surgery.

[0003] Valve replacement surgery provides one example of an area where percutaneous solutions are being developed. A number of diseases result in a thickening, and subsequent immobility or reduced mobility, of heart valve leaflets. Such immobility also may lead to a narrowing, or stenosis; of the passageway through the valve. The increased resistance to blood flow that a stenosed valve presents can eventually lead to heart failure and ultimately death. . 1 .

ο <N 2015224527 11 Sep

Treating valve stenosis or regurgitation has heretofore involved complete removal of the existing; native valve through an open-heart procedure followed by the implantation of a prosthetic valve Naturally, this is a heavily invasive procedure and inflicts great trauma on the body leading usually to great discomfort and considerable recovery time. It is also a sophisticated procedure that requires great expertise and talent to perform.

[9005] Historically, such valve replacement surgery has been performed using traditional open-heart surgery where the chest is opened, the heart stopped, the patient platted on cardiopulmonary bypass, tie native valve excised and the replacement valve attached. A proposed percutaneous valve replacement alternative method on the other hand, is disclosed in U.S. Pat. No. 6,168,614 (the entire contents of which are hereby incorporated by reference) issued to Andersen et al. in this patenti the prosthetic valve is mounted on a stent that is collapsed to a size that fits Within a catheter. The catheter is then inserted ihtO the patient’s vasculature and moved so as to position the collapsed stent at the location of the native valve. A deployment mechanism is activated that expands the stent containing the replacement valve against the valve cusps. The expanded structure includes a stent configured to have a valve shape with vaive leaflet supports begins to take on the function of the native vaive. As a result, a full valve replacement has been achieved but at a significantly reduced physical Impact to the patient.

[0006] However, this approach has decided shortcomings. One particular drawback with the percutaneous approach disclosed in the Andersen '614 patent is the difficulty in preventing leakage around the perimeter of the new valve after implantation. Since the tissue of the native valve remains within the lumen, there is a strong likelihood that the commissural junctions and fusion points of the valve tissue (as pushed apart and fixed by the stent) wliS make sealing around the prosthetic vaive difficult. In practice, this has often led to severe leakage of blood around the stent apparatus. -2- 2015224527 11 Sep 2015 |0007] Other drawoacks of the Andersen '614 approach pertain to its reliance on stents as support scaffolding for the prosthetic valve. First, stents can create emboli when they expand. Second, stents are typically not effective at trapping the emboli they dislodge, either during or after deployment, third, stents do not typically conform to the features of the native lumen in which they are placed, making a prosthetic valve housed within a stent subject to paravalvular leakage. Fourth, stents are subject to a tradeoff between strength and compressibility. Fifth, stents cannot be retrieved once deployed. Sixth, the inclusion of the valve Within the stent necessarily increases the collapsed diameter of the stent-valve complex and increases the cdlier of the materia! that must be delivered into the vasculature. £0008] As to the first drawback, stents usually fell into ope of two categories: selfexpanding stents and expandable stents. Self-expanding stents are compressed When loaded into a catheter and expand to their original, non-compressed size when released from the catheter; These are typically made of Nitinol. Balloon expandable stents are loaded info a catheter in a compressed but relaxed state. These are typically made from stainless steel or other malleable metals. A balloon is placed within the stent. Upon deployment, the catheter is retracted and the balloon inflated, thereby expanding the stent to a desired size. Both of these stent types exhibit significant force upon expansion. The force is usually strong enough to crack or pop thrombosis, thereby causing pieces of atherosclerotic plaque to dislodge and become emboli, if the stent is being implanted to treat a stenosed vessel, a certain degree of such expansion is desirable. However, if the stent is merely being implanted to displace native valves, less force may be desirable to reduce the chance of creating emboli. £0009] As to the second drawback, if emboli are created, expanded stents usually lave members that are too spaced apart to be effective to trap any dislodged material. Often, secondary precautions must be taken including the use of nets and irrigation ports. 3- [0010] the third drawback is due to the relative inflexibility of stents. Stents typically rely on the elastic nature of the native vessel to conform around the stent. Stents used to open a restricted vessel do not require a seal between the vessel and the stent. However, when using a stent to displace native valves and house a prosthetic valve, a seal between the stent and the vessel is necessary to prevent para valvular leakage. Due to the non-conforming nature of stents, this seal is hard to achieve, especially when displacing stenosed valve leaflets. 2015224527 11 Sep 2015 (00111 The fourth drawback is the tradeoff between compressibility and strength. Stents are made stronger or larger by manufacturing them with thicker members. Stronger stents are thus not as compressible as weaker stents. Most stents suitable for use in a valve are not compressible enough to be placed in a small diameter catheter, such as a 20Fr, 16Fr or even 14Fr catheter. Larger delivery catheters are more difficult to manoeuvre to a target area and also result in more trauma to the patient.

[0012] The fifth drawback of stents is that they are not easily retrievable. Once deployed, a stent may not be recompressed and drawn back into the catheter for repositioning due to the non-elastic deformation (stainless steel) or the radial force required to maintain the stent in place (Nitinol). Thus, if a physician is unsatisfied with the deployed location or orientation of a stent, there is little he or she can do to correct the problem.

[0013] The sixth drawback listed above is that the combination of the Valve within the stent greatly increases the size of the system required to deliver the prosthetic device. As a result, the size of the entry hole into the vasculature is large and often precludes therapy, particularly in children, smaller adults or patients with pre-existing vascular disease.

[0014] The present invention provides a support structure that expands gently* with gradual force, thereby minimizing the generation of emboli.

[0015] The present invention also provides a support structure that traps any emboli generated, thereby preventing the emboli from causing damage downstream. - 4 - [0016] Furthermore, the present invention provides a support structure that conforms to the features of the lumen in which it is being deployed, thereby preventing paravalvular leakage. 2015224527 04 Aug 2016 [0017] Additionally, the present invention provides a strong support structure capable of being deployed from a very small diameter catheter.

[0018] The present invention further provides a support structure that is capable of being retracted back into a delivery catheter and redeployed therefrom.

[0019] The present invention also provides a device that is delivered with the valve distinctly separated from the inside diameter of the final configuration of the support structure in order to reduce the amount of space required to deliver the device within the vasculature of the patient.

BRIEF SUMMARY OF THE INVENTION

[0019a] Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises”, is not intended to exclude other additives, components, integers or steps.

[0020] The present invention relates to a tubular mesh support structure for a native lumen that is capable of being delivered via a very small diameter delivery catheter. The tubular mesh is formed one or more fine strands braided together into an elongate tube. The strands may be fibrous, non-fibrous, multifilament, or monofilament. The strands exhibit shape memory such that the elongate tube may be formed into a desired folded shape, then stretched out into a very small diameter, elongated configuration. The small diameter, elongated configuration makes a very small diameter delivery catheter possible.

[0021] In various embodiments, upon deployment, the elongated tube is slowly pushed out of the delivery catheter, where it gradually regains its folded, constructed configuration. The tube conforms to the internal geometries of the target vessel. In addition, the braid effectively traps all emboli that may be released from the vessel walls. -5- [0022] As the tube continues to be pushed from the delivery catheter, it begins to fold in upon itself as it regains its constructed configuration. As it folds in upon itself, the forces exerted by each layer add together, making the structure incrementally stronger. Thus, varying levels of strength may be achieved without changing the elongated diameter of the device. 2015224527 22 Dec 2016 [0023] Using this folded tube, the valve can be attached such that the valve or other structure (such as a filter) in its elongated configuration within the delivery catheter does not reside within the elongated tube, but on deployment can be positioned in, above or below the tube.

[0023a] In one aspect, the present invention provides a valve assembly comprising: a tubular structure having a first configuration and biased toward a second configuration; a valve attached to said tubular structure; whereby in the first configuration, the tubular structure includes: a first end and a second end; an elongate body between the first end and the second end; whereby in the second configuration, the tubular structure includes at least one fold creating a section of the body having twice as many ply as the elongate body in said first configuration.

[0023b] In a further aspect, the present invention provides a valve assembly comprising: a mesh support structure having an unfolded extended state and a delivered, folded state; a valve including: a wireform connected to a first end of said mesh support structure; and, material attached to said wireform to form said valve; wherein said mesh support structure is biased toward said folded state.

[0023c] In a further aspect, the present invention provides a method of replacing a native valve comprising: introducing a length of material between valve leaflets of a native valve, said length of material having a prosthetic valve sutured to an end thereof; displacing said valve leaflets by folding a portion of said material within itself; releasing said material and said prosthetic valve.

[0023d] In a further aspect, the present invention provides a method when used for supporting native tissue of a target site, the method comprising: introducing unfolded material having been preformed to a folded configuration into the target -6- site, said material lacking sufficient structural integrity to support the native tissue in an unfolded configuration; building a supporting structure using said material in situ by folding said material along preformed folds. 2015224527 04 Aug 2016 [0023e] In a further aspect, the present invention provides a method when used for supporting native tissue or a target site comprising: introducing material into the target site lacking sufficient structural integrity to support the native tissue; building a supporting structure using said material in situ by folding said material upon itself until sufficient structural integrity to support the native tissue is attained.

[0023f| In a further aspect, the present invention provides a stentless support structure comprising: a tubular structure having a first configuration and a second configuration; whereby in the first configuration, the tubular structure includes: a first end and a second end; an elongate body between the first end and the second end; whereby in the second configuration, the tubular structure includes at least one fold creating a section of the body having more than one ply.

[0023g] In a further aspect, the present invention provides a method of implanting a support structure comprising: (a) percutaneously delivering a support structure in an elongated state inside a catheter to a target site; (b) retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site; (c) folding a second portion into said first portion, thereby creating a multi-layered support structure; (d) releasing the support structure and removing said catheter from the target site.

[0023h] In a further aspect, the present invention provides a stentless support structure comprising: a tubular structure having a first configuration and a second configuration; whereby in the first configuration, the tubular structure includes: a first end and a second end; an elongate tubular body between the first end and the second end; whereby in the second configuration, the tubular structure includes: at least one fold shortening the body and creating a section of the body having at least twice as many ply as the elongate body in the extended configuration. -6a- [0023Ϊ] In a further aspect, the present invention provides a method of implanting a support structure comprising: (a) percutaneously delivering a support structure in an elongated state inside a catheter to a target site; (b) retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter; (c) folding a second portion into said first portion, thereby creating a multi-layered support structure; (d) releasing the support structure and removing said catheter from the target site. 2015224527 04 Aug 2016

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a perspective view of a preferred embodiment of the present invention in an elongate configuration; [0025] Figure 2 is a side view of a preferred embodiment of the present invention; [0026] Figures 3-12 are a sequence of perspective views of a preferred embodiment of the present invention being deployed from a delivery catheter; [0027] Figure 13 is a perspective view of a preferred embodiment of the present invention; [0028] Figure 14 is a first end view of the preferred embodiment of Figure 13; [0029] Figure 15 is a second end view of the preferred embodiment of Figure 13; [0030] Figure 16 is a side view of a preferred embodiment of the present invention; [0031] Figure 17 is a second end view of the preferred embodiment of Figure 16; -6b- 2015224527 11 Sep 2015 [0032] Figure 18 Is a first end view of the preferred embodiment of Figure 16; [0033] Figure IS is a side view of a pretested embodiment of lie present invention; [8034] Figure 20 is a first ©rid view of the preferred embodiment of Figure 1|; [0035] Figure 21 is a second end view of the preferred embodiment of Figure 19; [0030] Figure 22 is a partial perspective view of a preferred embodiment of the present invention; [0037] Figure 23 is a partial perspective view of a preferred embodiment of the present invention; [0838] Figure 24 is a perspective view of a preferred embodiment of the present invention; [803$] Figure 25 is a side eievation of the embodiment of Figure 24; [0040] Figure 26 is a second end view of the embodiment of Figure 24; [0041] Figures 27-36 are a sequence of perspective views of a preferred embodiment of the present invention Being deployed from a delivery catheter against a clear plastic tube representing a native vaive; [0042] Figure 3? is a side eievation of a preferred embodiment of the present invention; [0043] Figure 38 Is an end view cf | downstream side of the embodiment of Figure 37; [0044] Figure II is an end view of an upstream side of the embodiment of Figure 37. -7- 2015224527 11 Sep 2015

DETAILED DESCRIPTION OF THE INVENTION

[0045] Referring now to the Figures and first to Figure 1, there is shewn a stentless support structure 10 of the present invention in an extended configuration. The vaive support 10 inciudes a first end 12, a second end 14 and an elongate tubular body 16 extending between the first end 12 and the second end 14.

[0046] Til© elongate tubular body 1# is preferably formed from one or a plurality of braided strands 18. The braided strands 18 are strands of a super-elastic or shape memory materia! such as Niihol. The strands are braided to term a tube having a centra! lumen 2G passing therethrough.

[0047] in one embodiment, the tubular body 16 Is folded in half upon itself such that the second end 14 becomes a folded end and the first end 12 includes a plurality of unbraided strands. The tubular body 16 is thus two-p!|, The unbraided strands of the first end 12 are gathered and joined together to form a plurality of gathered ends 22. The gathered ends 22 may be used as commissural points for attaching a prosthetic valve to the support structure 10. (See, e,g. Figure 2). Alternatively, as Shown in Figure 1, the gathered ends 22 may be used as attachment points for a wireform 24 defining a plurality of commissural points 26.

[0048] Notably, the commissural points 26 are positioned such that, when a valve is attached to the support structure ig the extended configuration, lie valve is longitudinally juxtaposed with the support structure rather than being located within the support structure. This juxtaposition aiiows the support structure 10 and valve to be packed into a very small catheter without damaging the delicate vaive. This longitudinal juxtaposition may be maintained when the support structure assumes a folded or constructed configuration (see Fig. 1i tor example), Of toe valve may become folded within the support structure^ [0049] Figures 3-6 show the second end 1| emerging from the catheter 28 to expose a first layer 30. In Figure 7, the first iapr 3D is completely exposed and has assumed its constructed configuration. NotSiy, the first layer 30 contracts .8-

ο <N 2015224527 11 Sep longitudinally when My deployed. Also shown in Figure 7 Is a second layer 3p beginning to emerge from the catheter 28. As the second layer exits the catheter, the pre-set supenelastie fold inverts the mesh, such that a second, inner layer is formed within the first outer layer. Alternatively, the first layer can be deployed against the wail of the vascular structure (such as an artery, vein, valve or heart muscle), As the second layer exits the catheter, the physician can aid inversion of the mesh my advancing the deployment system, in another embodiment, the mesh support structure can be advanced in the Vasculature such that it is deployed in a reverse direction (such as deployment through the apex Of the heart ventricle or from the venous system), where the mesh inversion occurs as a result Of pulling or retracting the deployment system.

[0050] In Figure 10, the second layer 32i| frilly deployed and the third layer 34 is fully exposed, but has not yet been inverted. Retracting the catheter 28, relative to the device 10, while advancing the catheter 28 slightly, relative to the target site, causes the third layer 34 to “pop” inwardly, thereby inverting itself against an inside surface of the second layer 32, as seen in Figure 11.

[0051] In Figure 12, additional material has been ejected from the catheter 28 such teat the third layer 34 is fully expanded against the second layer. One skilled in tee art will realize that numerous additional layers can be achieved in this manner, and that each layer adds additional radial strength to the resulting support structure ID.

[0052] Throughout the deployment process, the stentless support structure 10 emerges from the delivery catheter 28 gradually. This characteristic also allows the structure 10 to be pulled back into the delivery catheter: 28, in th® event that it is desired to relocate the support structure 10. Doing sc causes tee support structure 1 p to reacquire its extended configuration.

[0053] Having described the mechanics of building a support structure In situ, attention can now be turned to various embodiments made possible by the present -9- 2015224527 11 Sep 2015 invention. Figures 13-11 show a support structure 10 having many layers 38 and a first end 12 with numerous gathered ends 22 formed from unbraided strands. Some of the gathered ends 22 are attached to a wireform 24 having three commissural points 26. A prosthetic vaive 36, either harvested or manufactured, is attached to the wireform 24* Figure 15 shows the internal iumen 20 of the support structure 10.

[0054] Figures 16-18 show a support structure 10 having fewer iayers 38 and a wireform 24 with a prosthetic vaive 36 attached thereto. The first end 12 (hidden), to Which the wireform 24 is attached, has been preformed to fold inwardly upon deployment Thus, the wireform 24 and prosthetic valve 36, is located in the inner iumen 20 of the support structure 10 when the support structure 10 is in a constructed configuration.

[00SS] Figures 19-21 show a support structure 10 with severs! layers 38 and a first end 12 preformed to have a smaller diameter than the rest of the layers and the second end 14, which is Hided. The terminal ends of the braided Strands at the first end 12 have not been formed into gathered ends. Rather, the wireform 24 is attached to; the braids. The prosthetic valve 36 is attached to the wireform 24 and has skirting tissue 40, which is placed around the outside of the end 12. The skirting tissue 40 may be adhered to the first end 12.

[0056] Figure 22 shows a stentless support structure 10 with a Hided end 14, which has been foided back on itself, and a material 42 trapped between the two layers Of the fold. The materiai 42 is provided to further improve the paravaivuiar leak prevention and embolic trapping characteristics of the stentless support structure 10. The material 42 could consist of a non-woven material, woven Of braided fabric, a polymer or other material! 0)8571 Figure 23 shows a stentiess support structure 10 that includes a fiber 44 that is larger than the rest of the strands comprising the support structure 10. Thus, Figure 23 demonstrates that strands of different sizes may be used in the braided support structure 10 without significantly affecting the minimum delivery size of the , 1©: 2015224527 11 Sep 2015 device. Different sized strands may be used in order to improve strength, provide stiffness, create valve attachment points, provide radiopaque markers, and the like.

[0058] Figures 24-26 show a stentlpss support structure 10 that has a first end 12 that has had the unbraided strands trimmed such that they do not extend past the first end 12 of the folded structure to. This embodiment may be used to create, preserve or enlarge a lumen. A prosthetic valve may or may not be attached to this embodiment |0059] Turning now to Figures 27-36, a deployment sequence of a preferred embodiment of the stentless support structure 10 rs shown whereby a clear piece of tubing 46 is used to demonstrate a targeted location of a native vessel; such as a native valve. In Figure 27, the delivery catheter 28 is advanced beyond the targeted vaive 46 and the stentiess support 10 is starting to be ejected from the catheter 28.

[0060] In Figure 28, enough of the stentless support 10 has been ejected that the second, folded end 14 has begun to cur! back on itself slightly, forming a cuff 48; In Figure 29, the cuff 48 is more visible and has assumed its full, deployed shape. The cuff 48 acts as a catch that a physician can use to visually or tactilely locate the targeted valve 46 and seat the stentless support 10 thereagainst. The cuff also acts to ensure the entire native lumen through the targeted valve 46 is now being filtered by the Support 10. Untike balloon expandable stents, blood flew is not significantly inhibited by the deployment of the stentless support structure 10. Also shown in Figure 29 is that the first layer 30 has been fully ejected from the catheter 28, as has much of the second layer 32. The first layer 30, being very flexible prior to reinforcement by subsequent layers, is able to conform to any shape of the targeted vessel. The second layer 32 has not yet inverted itself into the first layer 30, [0061] In Figure 30, the first layer 30 is deployed, the cuff 48 is acting against the valve 46, and the second layer 32 has been inverted In Figure 31, materia! forming the third layer 34 is ejected from the catheter 28 but the third layer 34 has not yet inverted, -11 - 2015224527 11 Sep 2015 [0062] In Figures 32-33, the catheter 28 is being advanced to anew the tmra layer 34 to invert into the second layer 32. The angle of Figure 32 shows the relatively lew profile created ly the first and second layers 30 and 32, and how litt.e resistance to blood flow is presented By the support structure 10.

[0063] In Figure 3% the first end 12 has emerged from the catheter 12, and the gathered ends 22 are showing. A wireform 24 Is attached to some of the gathered ends 22 and is nearly completely deployed from the delivery catheter 28. in Figures 35-36, the support structure 10 has been Completely released from the catheter 28. Figure 36 shows the size of the lumen 20 of the support structure 10;:

Figures 37-39 show a preferred embodiment 100 of the present Invention including a mesh support structure 102, a wireform 104 and a valve 106. The support structure 102 differs slightly from support structure 10, described previously, as it is constructed from a two individual wires 108. Upon completion of the braiding process, the two free ends of ire wire ana spliced together. As such, there are no free wire ends and the structure can be loaded into a delivery catheter ih a single-ply state (not shown}. In the deployed state shown in the figures, the support structure 102 is folded once to form a two-ply device.

[0065] The support structure 102 is preferably formed of a memory alloy such as htitihdl. The singie-wire construction allows the device to be compressed into an extremely small catheter, sue! as one sized 16Fr or smaller. Though the support structure gains rigidity by the two-ply deployed configuration, radial strength is a function of a several factors and can thus be varied widely.

First, as with the other embodiments, radial strength may be increased By incorporating more folds or layers into the deployed configuration of the support Rupture 102. The three-ply configuration shown in Figures 37-39 is the most preferred configuration because it only has tp be folded in on itself twice, mding deployment less complicated. :- 12- 2015224527 11 Sep 2015 |066?3 Second^ strength may he increased by using a heavier wire. Because the support structure 102 is made from a single-wire, and can thus be loaded into a catheter in a sing!e-piy configuration, a larger diameter wire may he used while maintaining a smalt diameter elongated profite. Support structures 102 have been constructed according to the present invention using single wires having diameters between 0.005 and 0.010 inches in diameter. Preferably, tee diameter of the wire is between 0.007 and 0.008 inches.

[0008] Third, strength may be increased by increasing the braid density. A lighter braid will result in a stronger support.

[008¾] Fourth, the strength may be increased by altering the heat setting parameters. Super-elastic and shape memory alloys, such as Nifinol, attain their deployed shape within He vasculature by being heat set. The wires are held in a desired configuration and heated to a predetermined temperature ter a predetermined period of time. After the wires cool, they become set to the new configuration. If the wires are later disfigured, they will return to tee set configuration upon heating or simply releasing tee wires. The force with which a super-elastic or shape memory alloy returns to a set configuration can be increased by modifying the temperature at which the configuration is set, dr by modifying the period of time the alloy is maintained at the elevated setting temperature. For example, good results have been attained setting a Unci support structure of the present invention it 530°C for 7 minutes. Stiffer support Structures can be made using the same Nitinol wire by setting the structure at a temperature Other than 530°C or by setting the structure at 530°C for a time other than 7 minutes, dr both.

[0Θ7Ο] The device 100 includes a wireform 104, to which a valve 106 is attached. The wireform 104 term eommissuraJ points 109 separated by arcuate portions 110. The arcuate portions 110 are attached to an inside surface of the support structure 102. The commissural points 109 facilitate natural and efficient opening arid closjlg of the valve 106. Alternatively......the valve commissural points can be attached to an outer surface of the support structure {not shown). -13- 2015224527 11 Sep 2015 [OffM] The valve 106 may be any form of prosthetic or harvested biological valve. Preferably, as shown in the Figures, the valve 106 is a valve having three leaflets. The valve 106 is sutured or otherwise attached to the wireform 104. Preferably, the valve 106 is cut or constructed to include a skirt portion 112 which continues along the length of foe support structure 102 in its deployed configuration.

[0072] Although the invention has been described in terms of particular embodiments and appiicationsi one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications Without departing from the spirit of cr exceeding foe scope Of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims (48)

1. The Claims Defining the Invention are as Follows:

   1. A valve assembly comprising: a tubular structure having a first configuration and biased toward a second configuration; a valve attached to said tubular structure; whereby in the first configuration, the tubular structure includes: a first end and a second end; an elongate body between the first end and the second end; whereby in the second configuration, the tubular structure includes at least one fold creating a section of the body having twice as many ply as the elongate body in said first configuration.
2. 2. The valve assembly of claim 1, wherein said valve comprises: non-native tissue attached to an inside of said tubular structure to form said valve.
3. 3. The valve assembly of claim 2, further comprising a wireform connecting said non-native tissue and said tubular structure.
4. 4. The valve assembly of any one of claims 1 to 3, wherein said elongate body, in said first configuration, comprises a two-ply body having material trapped between the plies.
5. 5. The valve assembly of any one of claims 1 to 4, wherein said tubular structure comprises a braided tube.
6. 6. The valve assembly of any one of claims 1 to 5, wherein said at least one fold comprises a heat-set fold.
7. 7. The valve assembly of claim 6, wherein said heat-set fold biases said tubular structure toward said second configuration.
8. 8. A valve assembly comprising: a mesh support structure having an unfolded extended state and a delivered, folded state; a valve including: a wireform connected to a first end of said mesh support structure; and, material attached to said wireform to form said valve; wherein said mesh support structure is biased toward said folded state.
9. 9. The valve assembly of claim 8, wherein said support structure is preformed such that said first end folds inwardly when released from a delivery catheter, said folding causing said wireform and said valve to be located at least partially inside the support structure when said support structure is in said folded state.
10. 10. The valve assembly of claim 8 or claim 9, wherein said wireform is connected to braids of said support structure.
11. 11. The valve assembly of any one of claims 8 to 10, wherein said support structure comprises two plies in said folded configuration.
12. 12. The valve assembly of claim 11, wherein said support structure further comprises material trapped between said plies in said folded configuration.
13. 13. The valve assembly of any one of claims 8 to 12, wherein in said mesh support structure comprises a second end opposite said first end and wherein said second end comprises a folded end that curls back on itself to form a cuff when deployed from a catheter.
14. 14. The valve assembly of claim 13, wherein said cuff comprises a funnel shape that funnels blood through said support structure.
15. 15. A method of replacing a native valve comprising: introducing a length of material between valve leaflets of a native valve, said length of material having a prosthetic valve sutured to an end thereof; displacing said valve leaflets by folding a portion of said material within itself; releasing said material and said prosthetic valve.
16. 16. The method of claim 15, wherein folding said length of material in on itself results in said prosthetic valve being located within said material.
17. 17. The method of claim 15 or claim 16, wherein introducing a length of material between valve leaflets of a native valve comprises introducing a length of braided tubular structure.
18. 18. The method of claim 17, wherein introducing a length of braided tubular structure having a non-woven liner attached to an inside surface of said braided tubular structure.
19. 19. The method of claim 15, wherein introducing a length of material between valve leaflets of a native valve comprises: releasing a distal end of said length from a delivery catheter and allowing said distal end to curl back on itself to form a cuff; using said cuff to funnel blood through said length of material.
20. 20. The method of any one of claims 15 to 19, further comprising the step of observing proper function of said prosthetic valve prior to the step of releasing said length of material and said prosthetic valve.
21. 21. A method when used for supporting native tissue of a target site, the method comprising: introducing unfolded material having been preformed to a folded configuration into the target site, said material lacking sufficient structural integrity to support the native tissue in an unfolded configuration; building a supporting structure using said material in situ by folding said material along preformed folds.
22. 22. The method of claim 21 wherein introducing material into the target site lacking sufficient structural integrity to support the native tissue comprises introducing a braided, elongate mesh tube.
23. 23. The method of claim 22 wherein introducing a braided, elongate mesh tube of at least one strand of a material selected from the group consisting of super-elastic and shape memory.
24. 24. The method of claim 23 wherein introducing a braided, elongate mesh tube of at least one strand of a material selected from the group consisting of super-elastic and shape memory comprises introducing a braided, elongate mesh tube of a single Nitinol strand.
25. 25. The method of any one of claims 21 to 24 wherein building a supporting structure using said material in situ comprises folding said material upon itself one or more times until sufficient structural integrity to support the native tissue is attained.
26. 26. The method of claim 25 wherein folding said material upon itself until sufficient structural integrity to support the native tissue is attained comprises: introducing a delivery catheter to the target site containing said material in an elongated form; exposing a first length of said material, thereby allowing said first length of material to expand; advancing a second length of said material inside said first length; exposing said second length of said material, thereby allowing said second length to expand against an inside surface of said first length.
27. 27. A method when used for supporting native tissue of a target site comprising: introducing material into the target site lacking sufficient structural integrity to support the native tissue; building a supporting structure using said material in situ by folding said material upon itself until sufficient structural integrity to support the native tissue is attained.
28. 28. The method of claim 27 wherein introducing material into the target site lacking sufficient structural integrity to support the native tissue comprises introducing a braided, elongate mesh tube.
29. 29. The method of claim 28 wherein introducing a braided, elongate mesh tube of at least one strand of a material selected from the group consisting of super-elastic and shape memory.
30. 30. The method of claim 29 wherein introducing a braided, elongate mesh tube of at least one strand of a material selected from the group consisting of super-elastic and shape memory comprises introducing a braided, elongate mesh tube of a single Nitinol strand having been preformed to a folded configuration.
31. 31. The method of claim 27 wherein folding said material upon itself until sufficient structural integrity to support the native tissue is attained comprises: introducing a delivery catheter to the target site containing said material in an elongated form; exposing a first length of said material, thereby allowing said first length of material to expand; advancing a second length of said materia! inside said first length; exposing said second length of said material, thereby allowing said second length to expand against an inside surface of said first length.
32. 32. A stentless support structure comprising: a tubular structure having a first configuration and a second configuration; whereby in the first configuration, the tubular structure includes: a first end and a second end; an elongate body between the first end and the second end; whereby in the second configuration, the tubular structure includes at least one fold creating a section of the body having more than one ply.
33. 33. The stentless support structure of claim 32 wherein said at least one fold shortens the body longitudinally in the second configuration.
34. 34. The stentless support structure of claim 32 wherein said tubular structure comprises a single ply in the first configuration.
35. 35. The stentiess support structure of claim 32 wherein said tubular structure comprises a multi-ply section in the second configuration.
36. 36. The stentless support structure of claim 32 wherein said plurality of strands braided together to form a tubular structure comprises a plurality of strands of a first diameter and at least one fiber of a second diameter larger than the first diameter.
37. 37. The stentless support structure of claim 32 wherein said first end comprises a wire form having a plurality of commissural attachment points.
38. 38. The stentless support structure of claim 32 further comprising a lining in an inner wall of the tubular structure.
39. 39. The stentless support structure of claim 35 further comprising a lining sandwiched between a first and second ply.
40. 40. A method of implanting a support structure comprising: (a) percutaneously delivering a support structure in an elongated state inside a catheter to a target site; (b) retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site; (c) folding a second portion into said first portion, thereby creating a multilayered support structure; (d) releasing the support structure and removing said catheter from the target site.
41. 41. The method of claim 40 wherein step (b) comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site, said first portion including a distal end and a proximal end, the distal end including a cuff.
42. 42. The method of claim 41 wherein step (b) comprises: retracting said catheter relative to said support structure until said cuff expands and contacts the native tissue of the target site; pulling said cuff in a proximal direction until the cuff contacts a distal side of a native valve; retracting said catheter relative to said support structure until said proximal side of said first portion expands and contacts the native tissue of the target site.
43. 43. A stentless support structure comprising: a tubular structure having a first configuration and a second configuration; whereby in the first configuration, the tubular structure includes: a first end and a second end; an elongate tubular body between the first end and the second end; whereby in the second configuration, the tubular structure includes: at least one fold shortening the body and creating a section of the body having at least twice as many ply as the elongate body in the extended configuration.
44. 44. A method of implanting a support structure comprising: (a) percutaneously delivering a support structure in an elongated state inside a catheter to a target site; (b) retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter; (c) folding a second portion into said first portion, thereby creating a multilayered support structure; (d) releasing the support structure and removing said catheter from the target site.
45. 45. The method of claim 44 wherein step (b) comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue of the target site, said first portion including a distal end and a proximal end, the distal end including a cuff.
46. 46. The method of claim 45 wherein step (b) comprises: retracting said catheter relative to said support structure until said cuff expands and contacts the native tissue of the target site; pulling said cuff in a proximal direction until the cuff contacts a distal side of a native orifice; retracting said catheter relative to said support structure until said proximal side of said first portion expands and contacts the native tissue of the target site.
47. 47. The method of claim 44 wherein retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands outside of said catheter against native tissue of the target site.
48. 48. The method of claim 44 wherein step (b) comprises retracting said catheter relative to said support structure such that a first portion of said support structure expands against native tissue belonging to the group consisting of valve tissue, blood vessel tissue, and heart tissue.