SPACER FOR SECURING A TRANSCATHETER VALVE TO A BIOPROSTHETIC CARDIAC STRUCTURE

Abstract

A spacer for creating a docking station for a transcatheter heart valve is provided. The spacer changes an effective diameter and/or a shape of an implanted bioprosthetic structure such as a bioprosthetic heart valve or annuloplasty ring, providing a supporting structure into which the transcatheter valve expands without over expanding. The spacer may be deployed through an interventional technique either through transseptal access, transfemoral access, or transapical access and is typically deployed at least in part on an inflow portion of the implanted bioprosthetic structure.

Claims

1. A spacer for implantation into a bioprosthetic cardiac structure such as a bioprosthetic heart valve or annuloplasty ring about a native valve, comprising: a central flow axis having an upstream direction and a downstream direction, the downstream direction corresponding to the direction of blood flow from an upstream portion of the bioprosthetic cardiac structure through leaflets in a downstream portion of the valve when the spacer is implanted; the spacer configured for percutaneous delivery and engageable with the bioprosthetic structure, the spacer having a transcatheter valve mounting surface; the spacer further comprising a spacer shaft adapted to receive a transcatheter valve and providing a surface onto which the transcatheter valve may secure, the spacer having a first flange for mounting on an upstream portion of the bioprosthetic structure and a second flange for mounting on the bioprosthetic cardiac structure in the downstream direction relative to the first flange, the spacer shaft interconnecting the first flange and the second flange, the first flange having a dimension greater than the second flange and greater than an inner diameter of the bioprosthetic cardiac structure, the first and second flanges being rings; wherein the bioprosthetic cardiac structure is one of a prosthetic heart valve and an annuloplasty ring.

2. A spacer for implantation into a bioprosthetic cardiac structure such as a bioprosthetic heart valve or annuloplasty ring about a native valve, comprising: a central flow axis having an upstream direction and a downstream direction, the downstream direction corresponding to the direction of blood flow from an upstream portion of the bioprosthetic cardiac structure through leaflets in a downstream portion of the valve when the spacer is implanted; the spacer configured for percutaneous delivery and engageable with the bioprosthetic structure, the spacer having a transcatheter valve mounting surface.

3. The spacer of claim 2, further comprising a spacer shaft adapted to receive a transcatheter valve and providing a surface onto which the transcatheter valve may secure.

4. The spacer of claim 2, wherein the spacer further comprises a first flange for mounting on an upstream portion of the bioprosthetic structure.

5. The spacer of claim 3, wherein the spacer further comprises a second flange for mounting on the bioprosthetic cardiac structure in the downstream direction relative to the first ring flange, the spacer shaft interconnecting the first flange and the second flange.

6. The spacer of claim 5, wherein the first flange has a dimension greater than the second flange and greater than an inner diameter of the bioprosthetic cardiac structure.

7. The spacer of claim 2, wherein the spacer comprises anchors for securing the spacer to the bioprosthetic heart valve.

8. The spacer of claim 7, wherein the second flange comprises the anchors.

9. The spacer of claim 2, wherein the spacer comprises a shape memory material and is self-expanding.

10. The spacer of claim 5, wherein the second flange is adapted to be secured to an inner diameter of a cylindrical space in an upstream portion of a bioprosthetic cardiac structure relative to valve leaflets that are in a downstream direction relative to the cylindrical space.

11. The spacer of claim 2, wherein at least a portion of the spacer is balloon-expandable.

12. The spacer ring of claim 2, wherein the spacer includes snares connected thereto to control expansion of the spacer.

13. The spacer of claim 2, wherein at least a portion of the spacer is covered with fabric.

14. The spacer of claim 2, wherein the spacer comprises a cobalt-chromium alloy.

15. The spacer of claim 2, wherein a portion of the spacer is adapted to secure to a stiffening band in a cylindrical space in the bioprosthetic cardiac structure.

16. The spacer of claim 3, wherein the spacer shaft is substantially cylindrical.

17. The spacer of claim 5, wherein the second flange is a ring.

18. The spacer of claim 4, wherein the first flange is a ring.

19. The spacer of claim 18 wherein the first flange is a ring having a non-circular configuration to adapt to a non-circular portion of the bioprosthetic cardiac structure.

20. The spacer of claim 2 wherein the spacer comprises sensors that communicate sensor data.

21. The spacer of claim 3 wherein a shaft into which a THV may dock is spring loaded.

22. The spacer of claim 3 wherein a shaft into which a THV may dock comprises a compressible surface.

23. The spacer of claim 2, wherein the bioprosthetic cardiac structure is a prosthetic heart valve.

24. The spacer of claim 2, wherein the bioprosthetic cardiac structure is an annuloplasty ring.

25-45. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1 illustrates an embodiment of a spacer mounted onto a bioprosthetic mitral, tricuspid or aortic valve;

[0020] FIG. 2 is a top view of the spacer of FIG. 1;

[0021] FIG. 3 is a perspective view of the spacer of FIGS. 1 and 2;

[0022] FIG. 4 is a cross-section of the spacer ring of FIG. 3;

[0023] FIG. 5 is a cross-section of one embodiment of a surgical bioprosthetic valve illustrating a stiffening ring and a covering;

[0024] FIG. 6 is a cross-sectional view of a catheter delivery system with one non-limiting example of a self-expanding spacer ring inside, ready for deployment onto the bioprosthetic valve;

[0025] FIG. 7 illustrates a catheter delivery system of FIG. 6, with a pusher pushing a self-expanding upper ring flange portion of the spacer out of the delivery system;

[0026] FIG. 8 illustrates the expanded upper ring flange portion pulled into place on an upstream portion of the bioprosthetic valve;

[0027] FIG. 9 is the system of FIG. 8, with the spacer wall and the lower ring flange expanded into position and the spikes on the lower ring flange securing the spacer into fabric within the bioprosthetic valve;

[0028] FIG. 10 illustrates the delivery system being pulled away after the spacer ring has been implanted;

[0029] FIG. 11 illustrates an alternative embodiment in which snares control expansion of the spacer;

[0030] FIG. 12 illustrates an alternative embodiment in which the spacer has an upper flange and a spacer, but no downstream flange, with the struts not shown for simplicity;

[0031] FIG. 13 illustrates the spacer ring of FIG. 12 in cross-section;

[0032] FIG. 14 is a perspective view of a spacer interconnected with an annuloplasty ring;

[0033] FIG. 15 is a top view of the annuloplasty ring of FIG. 14;

[0034] FIG. 16 is a perspective view of the spacer of FIGS. 14 and 15;

[0035] FIG. 17 is a cross-section of the spacer of FIG. 16 taken at line 17-17;

[0036] FIG. 18 is a perspective view of the spacer of FIG. 14 with a cover disposed thereover; and

[0037] FIG. 19 illustrated the spacer of FIG. 18 with a transcatheter heart valve expanded therein.

DETAILED DESCRIPTION

[0038] FIG. 1 illustrates one embodiment of a spacer ring 5 deployed in a surgical mitral or tricuspid prosthetic valve 10, for example, a Carpentier-Edwards PERIMOUNT Magna Mitral Ease® mitral heart valve (Model 7300TFX, Edwards Lifesciences, Irvine, Calif.). The spacer ring 5 is provided to narrow or reduce the space an implanted bioprosthetic mitral, tricuspid, pulmonic, or aortic valve 10 into which the transcatheter valve is to be implanted, for example, a surgically implantable bioprosthetic valve. As discussed above, the spacer ring 5 is useful in situations in which an interior space or lumen of a previously implanted prosthetic valve is too large for direct implantation of a largest available transcatheter valve therein. FIG. 2 is a top view of the same spacer ring 5 in place on the surgical mitral or tricuspid valve 10. FIG. 3 is a perspective view of the spacer ring itself, and FIG. 4 is a cross-section of the spacer ring of FIG. 3.

[0039] Considering FIG. 4, the spacer has a first ring flange 20 on the upstream side, a spacer shaft 30 with an interior surface to which a transcatheter heart valve may secure, and a downstream lower ring flange 40 having anchors, barbs, or spikes 50. The spikes 50 are provided to secure the spacer ring to fabric on the interior of the surgical bioprosthetic valve. It is noted that the terms “upstream” and “downstream” are used in conjunction with an embodiment in which a bioprosthetic valve is the bioprosthetic structure to which the spacer is to attach, for example, and that the terms as used with other bioprosthetic structures to which the spacer attaches may simply refer to relative positions rather than strictly to directions in which blood flows.

[0040] FIGS. 1 and 2 illustrate a spacer 10 secured in place on bioprosthetic surgical heart valve 10. Once the spacer is in place, a transcatheter valve can be placed in the bioprosthetic valve in the same fashion as would be done in a smaller surgical valve, in which a spacer ring is not needed, with the transcatheter valve engaging the interior surface on the spacer that has been placed in the bioprosthetic valve. The spacer provides axial support for the transcatheter valve, so that the transcatheter valve will not move in either the upstream or the downstream direction, as well as radial support for an outer wall or stent of the transcatheter valve, thereby reducing a risk of over-expanding the transcatheter valve.

[0041] FIG. 5 is a cross-sectional view of a representative surgical bioprosthetic aortic valve 100, such as the Carpentier-Edwards PERIMOUNT® aortic heart valve (Model 2700TFX, Edwards Lifesciences) as just one example. The spacer and method are also adaptable to other prosthetic valves, for example, prosthetic valves with other structural details, as well as prosthetic valves designed for other native valve locations including pulmonic, mitral, and tricuspid prosthetic valves, as discussed above. As seen, the valve 100 has an inflow direction corresponding to the direction blood flows into the valve. The valve also has an outflow direction corresponding to the direction the blood flows as it exits the valve through the flaps (leaflets). The valve includes a fabric-covered stent portion supporting valve leaflets 80. On the inflow side of the valve is an annular cuff. On the interior of the valve is a generally cylindrical space 120, illustrated in the cross-sectional view of FIG. 5, backed by a stiffening ring 125 in the illustrated embodiment. Other embodiments of the valve do not include a stiffening ring. The interior is covered with fabric or other covering known in the art 130. This provides a space 120 onto which the spacer 10 (FIGS. 1-4) may mount on the inflow portion of the valve without substantially interfering with the operation of the leaflets 80, which could make the tissue valve incompetent. The spacer may be deployed through an interventional technique, for example, either through transseptal access, transfemoral access, or transapical access, and is typically deployed on or near the inflow end of the implanted bioprosthetic valve. Alternatively, the spacer may be deployed surgically, for example, in a minimally-invasive surgical (MIS) procedure.

[0042] Positioning a device within a beating heart can be difficult, for example, including one or more challenging steps. FIG. 6 is a cross-sectional view of a catheter 210 inserted within an artery 220 for delivery of the spacer 5′. The spacer 5′ includes upstream flange portion 20′, spacer surface portion 30′, and downstream flange portion 40′ having spikes 50′. A pusher 200 pushes the spacer 5′ upstream for delivery onto existing bioprosthetic valve 10′. In one embodiment the spacer is partially expanded such that the outside diameter of the upstream flange of the spacer is larger than the inside diameter of the surgical valve, as seen in FIG. 7. The spacer can then be pulled from the atrial position illustrated in FIG. 7 into contact with the implanted bioprosthetic valve (FIG. 8), where the expansion would be completed (FIG. 9), for example, by retracting the catheter 210 and/or adjusting a position of the pusher 200. In FIG. 10, the delivery system including the catheter 210 and the pusher 200′ pulled away from the spacer 5′ and bioprosthetic valve 10′. This approach permits aligning the spacer on the inflow aspect of the implanted valve without causing the surgical valve to become incompetent. With this approach, the spacer may be either a balloon-expandable device or a controlled self-expanding device. As seen in FIGS. 1 and 2, the structure of the spacer ring includes a series of struts, most commonly defining diamond-shaped cells, but in the alternative includes chevron-shaped cells, rectangular cells, and/or other cell shapes known in the art, and combinations thereof. The spacer may be expanded by other balloon and/or mechanical expansion methods known in the art. The spacer may also be partially self-expanding and partially balloon-expanded. As just one example, the upstream and/or downstream flanges may self-expanding, for example, while the central portion of the spacer is balloon-expanded. Entirely self-expanding embodiments can also be balloon expanded post-initial deployment, for example, to ensure that the spacer is fully expanded and/or to seat any anchors.

[0043] Considering this process in more detail, FIG. 6 illustrates a self-expanding spacer assembly 5′ inside a transcatheter delivery system in cross-section. In the illustrated embodiment, the spacer 5′ is in a delivery configuration in the catheter 210, with the upstream flange 20′, spacer shaft 30′, and downstream flange 40′ each extending generally longitudinally, and with the upstream flange 20′ and downstream flange 40′ radially compressed. In some embodiments, the spacer shaft 30′ is also radially compressed. The illustrated embodiment also includes a plurality of optional engagement means, engagement elements, or anchors 50′, which in other embodiments have a different configuration. As a pusher 200 pushes the spacer assembly 5′ out of the catheter 210, the upstream flange 20′ first extends longitudinally out of the opening at the distal end of the catheter 210, then flips or rotates down into a generally horizontal or radial position, as seen in FIGS. 6 and 7. The spacer and catheter are then pulled or retracted proximally so that the spacer contacts the valve, and expansion of the spacer, including spacer shaft 30′ and downstream ring 40′, continues as the spacer 5′ is urged out of the catheter 201, for example, by retracting the catheter while preventing proximal movement of the spacer 5′ using the pusher 200, as shown in FIG. 8. A series of spikes 50′ on the downstream ring 40′ then flip from a longitudinal delivery configuration to a radial deployed configuration as the downstream ring 40′ does the same. In the embodiment illustrated in FIG. 9, the pusher 200 is urged distally, for example, urging the downstream ring 40′ into the final deployed configuration and/or urging the anchors or spikes 50′ into the fabric disposed around the inner diameter of the implanted bioprosthetic valve 10′ to maintain and to secure the spacer in position. As the spacer is pushed out of the delivery system, the spikes 50′ extend across the inner diameter and into fabric of the surgical valve. As an alternative, the flanges 20′ and 40′ may be deployed to sandwich the structure 10′ to hold the spacer in place.

[0044] In a preferred embodiment, the upstream and downstream flanges and the spacer shaft are, in plan view, ring-shaped. However, it is noted that the flanges and the spacer shaft may take forms other than rings. Further, the upstream and downstream flanges and the spacer shaft may have different plan, cross-sectional geometries from one another, so long as they serve their respective purposes in the spacer assembly.

[0045] FIG. 11 illustrates that in an alternative embodiment, expansion of the spacer after leaving the delivery system may be controlled by snares 240. The snares 240 may be loops of suture material or wire, for example, or another suitable design. In one approach, the snares 240 extend up through a passageway in a pusher 200′. Expansion of the spacer 5′ is then controlled when the snares 240 are held relatively tightly in tension, then the tension released in a controlled manner, for example, gradually, until the spacer 5′ is in position, or in any manner appropriate in a given situation.

[0046] In some bioprosthetic valves, for example, certain bioprosthetic valves manufactured and provided by Edwards Lifesciences, the valve has a stiffening ring 125, as illustrated in FIG. 5. The stiffening ring 125 is typically a fabric-covered or otherwise covered ring preferably made of cobalt-chromium alloy (e.g., ELGILOY® alloy, Elgiloy Specialty Metals, Elgin, Ill.) that extends around the inflow aspect of the prosthetic valve, although the stiffening ring may include other materials, for example, any combination of stainless steel, nitinol, cobalt-chromium, and polymer. The stiffening ring 125 stabilizes and strengthens the prosthetic valve. As seen in FIG. 10, for example, length of the spacer portion and the lower ring is sufficiently short so as to ensure that the spiked portion of the spacer rings does not extend into or contact the leaflets of the valve, but will rather engage with the fabric covering 120 over the stiffening element on the inflow aspect.

[0047] In an alternative embodiment of a spacer, a cover made of fabric or suitable material may be placed over the spacer itself or over a portion thereof. In a preferred embodiment, the spacer does not have a cover, since a cover can add expense to the spacer and/or increase a delivery profile thereof. Moreover, many transcatheter valves do not have a fabric cover, so a cover disposed over the spacer would have no benefit. On the other hand, as an alternative, a cover on the spacer device may encourage fibrous tissue overgrowth and incorporation of the spacer into the transcatheter valve and the surgical valve, and/or reduce perivalvular leakage around an implanted transcatheter valve.

[0048] FIG. 12 illustrates an alternative embodiment in which the spacer has an upstream flange 320 and a spacer shaft 330, but no downstream ring below the spacer 330. FIG. 13 is a cross-sectional view of the spacer of FIG. 12, both of which are shown without struts for simplicity of illustration, although the ring would normally have struts as in FIGS. 1 and 2. The spacer of FIG. 12 may be secured with anchors or spikes 350, for example, disposed on the lower or outflow surface of the upstream flange 320, and/or disposed on an outer wall of spacer shaft 330 as shown.

[0049] In an embodiment of the spacer ring that is balloon-expandable, the spacer is preferably made from a material that is fairly close in the galvanic series to the transcatheter valve and/or to the prosthetic surgical valve. In this way, there is not a stress corrosion problem between metal portions of the transcatheter valve, metal portions of the spacer, and/or metal portions of the prosthetic surgical valve, for example, the stent of the transcatheter valve contacting the spacer shaft, or the band of the prosthetic surgical valve contacting the anchors of the spacer. For example, the spacer ring may be made of one or more of a stainless steel alloy, titanium alloy, nitinol, or a cobalt-chromium alloy, depending on the material of the transcatheter valve. Cobalt-chromium has a similar oxidation potential to nitinol, and consequently cobalt-chromium is a preferred material for use with transcatheter valves that include nitinol frames. A cobalt-chromium spacer ring could then be used with a transcatheter valve including nitinol and/or cobalt-chromium, for example, in a stent or frame, to avoid a corrosion problem.

[0050] Spacer rings according to the present invention may be used to provide a dock that secures to an annuloplasty ring, such as the Carpentier-Edwards® Classic Annuloplasty Ring (Edwards Lifesciences, Irvine, Calif.) with a titanium core and fabric cover, or any of a wide variety of other annuloplasty rings. The annuloplasty ring reshapes the valve annulus, so that the native valve leaflets may properly coapt. Still, the native valve may ultimately need replacement with, for example, a transcatheter heart valve. A spacer structure that is secured to the annuloplasty ring may provide a docking region suitable for a THV to expand into and anchor. The drawings illustrate an exemplary D-shaped annuloplasty ring, although the spacer is applicable to rings of other shapes, including open rings or bands, as well as with rigid or flexible rings. Embodiments of the spacer are applicable to both mitral and tricuspid annuloplasty rings. In some embodiments, the spacer provides a structure at the open portion of an open ring that constrains THV expansion, for example, against the left ventricular tract (LVOT), thereby reducing the likelihood of LVOT obstruction in such cases. As with the embodiments of the spacer described and illustrated above, embodiments of annuloplasty-ring spacers have a longitudinal or vertical profile that permits the native leaflets to remain competent when the spacer is engaged to the annuloplasty ring, before a THV is deployed therein.

[0051] FIGS. 14 and 15 illustrate a spacer 405 that is secured to a generally D-shaped annuloplasty ring 410. The annuloplasty ring 410 includes a central open cylindrical shaft 415, an upper flange 420, a surface 430 within the cylindrical shaft onto which a THV can expand and anchor, and a lower flange 440. The curved armatures of the upper and lower flanges have lengths chosen to adapt to the shape of the annuloplasty ring 410. The annuloplasty ring 410 is typically covered with a fabric covering, and spikes 450 extend from the lower flange 440 into the fabric to help secure the spacer 405 to the annuloplasty ring 410. The upper flange 420 of the spacer is typically against an upper surface of the annuloplasty ring and may optionally secure to a fabric covering of the annuloplasty ring with spikes or other attaching means. FIGS. 16 and 17 illustrate the expanded spacer 405 in isolation.

[0052] The spacer may be secured to the annuloplasty ring in the manner illustrated in FIGS. 6-9. As with some other embodiments, snares may be used to control expansion of the spacer ring during deployment. Alternatively, the second flange may be deployed such that the annuloplasty ring is sandwiched in between the first and second flanges.

[0053] From another perspective, one embodiment of a docking station is designed to seal at the proximal inflow section to create a conduit for blood flow and to prevent pericardial leakage. The distal outflow section, however, is generally left open. In one specific embodiment, cloth, such as a polyethylene terephthalate (PET) cloth for example, or other material covers the proximal inflow section, but the covering does not cover at least a portion of the distal outflow section. The openings in the cloth are small enough to significantly impede blood passage therethrough. Again, a variety of other biocompatible covering materials may be used such as, for example, a fabric that is treated with a coating that is impermeable to blood, polyester, polytetrafluoroethylene fabric (PTFE, for example, ePTFE), a processed biological material, such as pericardium, or other coverings known in the art. The spacer ring may alternatively be fully covered, or covered only in selected areas. When the surface to which the THV secures is covered, the covering may assist in creating a tight seal and/or improving engagement with the THV.

[0054] In another aspect, the inner diameter of the spacer ring remains within the operating range of the THV. Consequently, the THV can operate within a space that otherwise would be too wide for the THV to operate properly, and/or in a space that otherwise would not permit a THV to reliably secure, for example, the D-shaped opening illustrated in the drawings.

[0055] As noted previously, the spacers may be self-expanding or balloon expanded. In a balloon expanded embodiment, one or more balloons inflates to expand the spacer. The balloons are removed, and a THV is delivered and expanded into the central shaft of the spacer. Other methods of expansion known in the art may be employed. For example, the spacer ring may be bundled with the THV prior to delivery, with both the spacer ring and the THV being delivered and expanded in a single delivery.

[0056] In another embodiment, the spacer may include a sensor, such as a pressure sensor. As one use for a sensor, the pressure of the docking station against the vessel wall may be detected during deployment. The sensor may communicate sensor data via a delivery catheter, for example. The data is used during balloon expansion, for instance, to determine when sufficient pressure against the vessel wall, the surgical valve and/or the annuloplasty ring as the case may be has been achieved, such that further expansion is not necessary. This approach may be useful when the dimensions, elasticity of the vessel walls, and/or other variables are uncertain prior to expansion of the docking station.

[0057] In another aspect, the outer surface of the spacer may be secured by positive pressure. A THV is expanded into the inner surface of the ring. The inner ring may be “spring loaded” to maintain force against the THV, thereby holding the THV in place. A stent structure in between the inner and outer ring surfaces may provide the spring loading. Alternatively, spring-like mechanisms may be built into the space in between the inner and outer ring surfaces.

[0058] In other alternative, an inner ring acts as a landing zone into which the THV docks. The inner ring may have a soft or compressible inner surface, such as foam, a resilient polymer, a hydrogel, or other suitable biocompatible material. The inner surface may give way under the force of the expanded THV. The area between the inner surface and outer surface of the ring may be sealed, such as with a fabric covering or a skirt that is on an interior surface of the ring, or otherwise have s surface that prevents the bypass of blood around the THV. It is noted that “ring” as used herein includes shapes that are not circular in cross-section, such as for example the outer ring that conforms to a D-shape or other shape in order to secure the outer ring to the supporting structure.

[0059] In view of the many possible embodiments to which the disclosed principles may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.