PROSTHETIC HEART VALVE WITH SUTURE LOOP PREVENTING MEMBER

Abstract

A prosthetic heart valve system includes a prosthetic heart valve having an inflow side, and an outflow side. The heart valve further includes a base at the inflow side, a plurality of commissure posts and valve leaflets secured to the commissure posts to permit flow through the heart valve. An anti-loop member has a first portion on the inflow side of the heart valve and a second portion on the outflow side of the heart valve. The second portion of the anti-loop member is arranged along each commissure post at the tip of each commissure post, and arranged along at least one commissure post twice to form a loop around all of the commissure posts. The anti-loop member is made of a material sufficiently flexible to be removed from the commissure posts without damaging the heart valve yet rigid enough to retain its shape when coming in contact with sutures.

Claims

1. A prosthetic heart valve system, comprising: a prosthetic heart valve having an inflow side and an outflow side, and a flow axis therethrough, the heart valve further comprising a base at the inflow side, a plurality of commissure posts extending from the base away from the inflow side and circumferentially spaced around the flow axis, and valve leaflets secured to the commissure posts to permit flow through the heart valve, each commissure post having a tip on the outflow side; and an anti-loop member having a first portion and a second portion, the first portion of the anti-loop member on the inflow side of the heart valve and the second portion of the anti-loop member on the outflow side of the heart valve; the second portion of the anti-loop member arranged along each commissure post at the tip of each commissure post, and arranged along at least one commissure post twice to form a loop around all of the plurality of commissure posts; wherein the anti-loop member comprises a material sufficiently flexible to be removed from the commissure posts without damaging the heart valve by pulling on the first end portion of the anti-loop member yet rigid enough to retain its shape when coming in contact with sutures used to secure the heart valve to a heart valve annulus.

2. The prosthetic heart valve system of claim 1, wherein the second portion of the anti-loop member is attached to each commissure post at the tip of each commissure post and to the at least one commissure post twice, to form the loop around all of the plurality of commissure posts.

3. The prosthetic heart valve system of claim 2, wherein the plurality of commissure posts is three or more commissure posts.

4. The prosthetic heart valve system of claim 2, wherein the anti-loop member is attached to a side of each commissure post facing away from the flow axis.

5. The prosthetic heart valve system of claim 2, wherein the anti-loop member loops around the plurality of commissure posts twice.

6. The prosthetic heart valve system of claim 5, wherein an outer loop of the anti-loop member is attached to a side of each commissure post facing away from the flow axis and an inner loop of the anti-loop member is inside the outer loop.

7. The prosthetic heart valve system of claim 2, wherein the anti-loop member is a superelastic nitinol.

8. The prosthetic heart valve system of claim 2, wherein the anti-loop member is shape set in a coiled form.

9. The prosthetic heart valve system of claim 2, wherein a free end of the second portion of the anti-loop member is located radially inside the periphery of the plurality of commissure posts.

10. The prosthetic heart valve system of claim 2, wherein a free end of the second portion of the anti-loop member is an enlarged portion shaped to prevent damage to surrounding tissue.

11. The prosthetic heart valve system of claim 10, wherein the enlarged portion is in the shape of a ball.

12. The prosthetic heart valve system of claim 2, wherein the base of the prosthetic heart valve comprises a sewing ring to engage a native valve annulus and the anti-loop member passes through the sewing ring.

13. The prosthetic heart valve system of claim 12, wherein the anti-loop member passes through the sewing ring adjacent an inner diameter of the sewing ring.

14. The prosthetic heart valve system of claim 13, wherein the anti-loop member extends from a tip of one commissure post and through the sewing ring at a location closer to an adjacent commissure post than the one commissure post.

15. A prosthetic heart valve system, comprising: a prosthetic heart valve having an inflow side and an outflow side, and a flow axis therethrough, the heart valve further comprising a base at the inflow side, a plurality of commissure posts extending from the base away from the inflow side and circumferentially spaced around the flow axis, and valve leaflets secured to the commissure posts to permit flow through the heart valve, each commissure post having a tip on the outflow side; an anti-loop member having a first portion and a second portion, the first portion of the anti-loop member on the inflow side of the heart valve and the second portion of the anti-loop member on the outflow side of the heart valve; the second portion of the anti-loop member arranged along each commissure post at the tip of each commissure post, and arranged along at least one commissure post twice to form a loop around all of the plurality of commissure posts; and a valve holder removably secured to the prosthetic heart valve; wherein the anti-loop member comprises a material sufficiently flexible to be removed from the commissure posts without damaging the heart valve by pulling on the first end portion of the anti-loop member yet rigid enough to retain its shape when coming in contact with sutures used to secure the heart valve to a heart valve annulus.

16. The prosthetic heart valve system of claim 15, wherein the first portion of the anti-loop member is secured to the valve holder such that removal of the valve holder from the heart valve also results in removal of the anti-loop member from the heart valve.

17. The prosthetic heart valve system of claim 15, wherein the valve holder is secured to the prosthetic heart valve by sutures.

18. The prosthetic heart valve system of claim 15, further comprising a handle removably attachable to the valve holder.

19. The prosthetic heart valve system of claim 15, wherein the first portion of the anti-loop member comprises an indicator to alert a member of the surgical team to remove the anti-loop coil.

20. The prosthetic heart valve system of claim 19, wherein the indicator is a contrasting color to the environment.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Further features and advantages will become apparent from the description of embodiments using the accompanying drawings. In the drawings:

[0024] FIG. 1 shows a schematic cross-sectional view of a human heart;

[0025] FIG. 2 shows a schematic perspective view of an example of a prosthetic valve that can be used with some embodiments;

[0026] FIG. 3A is a schematic view of a prosthetic heart valve as it is parachuted to a mitral valve opening;

[0027] FIG. 3B is a schematic view of the prosthetic heart valve of FIG. 3A just before entering the mitral valve opening;

[0028] FIG. 3C is a schematic view of the prosthetic heart valve of FIG. 3A after entering the mitral valve opening, as shown from the opposite side of the mitral valve opening;

[0029] FIG. 4 is a prosthetic heart valve with an anti-loop member according to an embodiment;

[0030] FIGS. 5A-5C are a sequence of views showing the prosthetic heart valve and anti-loop member of FIG. 4 as it is parachuted to a valve opening;

[0031] FIG. 5D is a view of the prosthetic heart valve and anti-loop member of FIG. 4 after entering the valve opening, as shown from the opposite side of the valve opening;

[0032] FIGS. 6A-6E are a sequence of views showing removal of the anti-loop member from the prosthetic heart valve of FIG. 4 as shown from the opposite side of the valve opening;

[0033] FIG. 7 is a perspective view of the heart valve and anti-loop member of FIG. 4 attached to a holder.

DETAILED DESCRIPTION

[0034] Disclosed herein are various embodiments of a prosthetic heart valve with anti-loop member for assisting in the delivery and implantation of a prosthetic heart valve at an implant site, and methods for preparing the prosthetic heart valve for such procedures. Embodiments of the prosthetic heart valve with anti-loop member herein are easy to use and simple in design.

[0035] The valve systems disclosed herein are particularly useful for avoiding suture looping during advancement of the prosthetic valve to the implant site as well as during final suturing of the valve at the native valve annulus. In procedures where commissure posts of the prosthetic valve point distally, for example in many mitral valve replacement procedures, the commissure posts point in the direction of valve advancement and may be more prone to suture looping or other entangling. In these cases, an anti-loop member according to embodiments disclosed herein deflects the pre-installed sutures away from the prosthetic valve. In some embodiments, the anti-loop member is pre-deployed without requiring any action by the surgeon or operating room staff and is ready for delivery to the native valve annulus upon removal of the packaging. Upon securement of the prosthetic heart valve to the native valve annulus, the anti-loop member can be easily removed from the heart valve without causing any damage to the valve or valve leaflets. In this fashion, ease of use can be maintained, while user error can be minimized. In addition, in some embodiments, the surgical team has improved visibility of the surgical site during the procedure.

[0036] With reference to FIG. 4, a prosthetic heart valve system 100 includes a prosthetic heart valve 102 and an anti-loop member 104. The heart valve 102 has a base including an annular sewing ring 106 on an inflow side, and a plurality of commissure posts 108a, 108b, 108c projecting generally axially in the outflow direction. The inflow side of the valve 102 is the proximal (e.g., accessible) side during implantation and the commissure posts 108 project distally toward the outflow side of the valve 102, defining the leading end of the valve during implantation.

[0037] The heart valve 102 further includes a plurality of flexible leaflets 110 that are supported by and extend between the commissure posts 108. The leaflets 110 provide the occluding surfaces of the valve 102, and may be made of individual pieces of bovine pericardium, for example. Alternatively, the leaflets 110 may be part of an entire xenograft, or homograft. In the former instance, natural porcine (pig) valves are particularly useful. Therefore it should be understood that the leaflets 110 may be formed of a variety of materials, none of which is limiting with respect to the present disclosure. In addition, there are preferably three such leaflets 110 corresponding to the three commissure posts 108.

[0038] Various constructions for the heart valve 102 are known, which may include metallic or plastic stent elements, a silicone or urethane insert for the sewing ring 106, biocompatible fabric or cloth (e.g., polyester) covering around one or more of the elements. In a preferred embodiment, the heart valve 102 includes an internal metallic wireform (not shown) having an undulating shape with a plurality of arcuate cusps connected by the upstanding commissures. The wireform commissures provide internal structure for the commissure posts 108 of the valve, and are somewhat flexible so as to be able to flex or cantilever inward.

[0039] The anti-loop member 104 is preferably a fine guide wire made of a flexible material such as a superelastic nitinol or other suitable material. Preferably, the guide wire is in the form of a coil and the material is such that the coil is not permanently bent or deformed after coiling. This permits the coil to be passed through the commissure tips during assembly without permanently deforming and permits easy removal from the commissure posts without pulling on the cloth and damaging the heart valve. In addition, the coil material is preferably rigid enough to retain its shape when coming in contact with sutures used to secure the heart valve to the heart valve annulus to prevent suture looping. In a preferred embodiment, the coil is shape set in a circular or otherwise coiled form before attaching it to the commissure tips so that the free end does not stick out of the coil at the outflow side.

[0040] The anti-loop member 104 has a first end portion 116 and a second end portion 118. The anti-loop member 104 is assembled to the prosthetic heart valve 102 by taking the free end 120 of the first end portion 116 and passing it through the covering or an attached loop (such as by a suture) at the tip of the first commissure post 108a, then through the covering or loop at the tip of the second commissure post 108b and through the covering or loop at the tip of the third commissure post 108c. Preferably, the free end 120 continues to be fed to the first commissure post 108a such that the anti-loop member 104 extends from the first commissure post 108 around the periphery of the heart valve to the second and third commissure posts 108b, 108c and back to the first commissure 108a. If desired, the free end 120 of the first end portion 116 can continue to be passed through the commissures posts 108b, 108c consecutively. In the embodiment of FIG. 4, the anti-loop member passed through each commissure post twice before being passed through the sewing ring 106 to be engaged by a forceps (or other means) for removal after the heart valve has been placed or secured on the valve annulus. Preferably, the anti-loop member 104 passes through the sewing ring 106 at an inner diameter portion 107 of the sewing ring. This will permit easier removal of the anti-loop member after the heart valve is seated on the valve annulus.

[0041] If the anti-loop member is coiled around the commissures twice, the inner coil may be attached on an inner side of the commissure posts while the outer coil may be on an outer side of the commissure posts. Alternatively, the coils may be adjacent each other, both on the outside, both on the inside, or other variations. It will be appreciated that the anti-loop member 104 can be assembled to the heart valve in the opposite direction also (e.g., through the sewing ring 6 first, then through the commissure posts.

[0042] To prevent the free end of the second end portion 118 of the coil from scratching or damaging surrounding tissue, a small ball 130, or other shape of protector, can be attached to it. The ball is small enough so that it does not impede pulling the coil through the commissures. A plastic ball can be molded onto the free end of the coil. Alternatively, a metal ball may be formed by melting the free end of the coil so that nothing may fall off the free end. Other shapes may be used as long as the shape not only prevents the coil's free end from poking into the surrounding heart tissue but also does not impede pulling the coil through its attachment points on the commissures.

[0043] With reference to FIGS. 5A-5D, the prosthetic heart valve 102 is shown in a sequence of views as it is parachuting to a valve opening 140 of the human heart. As is well known in the art, several sutures are passed through a valve annulus 142 and through the sewing ring 106. Only one suture 144 is shown for clarity.

[0044] As the heart valve 102 is parachuted to the valve annulus 142 (FIG. 5A), it is seen that the anti-loop member 104 is in position to deflect the suture 144 to a location outside the commissure posts 108 to prevent suture looping (FIG. 5B). Tilting of the heart valve 102 for easier entry into the valve opening can also be safely achieved without suture looping due to the location of the anti-loop member 104 (FIG. 5C). The suture 144 is deflected by the anti-loop member 104 to prevent it from looping inside the commissure post 108. Once the heart valve 102 is fully seated against the valve annulus 142 (FIG. 5D, viewed from the opposite side of the valve opening), the surgeon is able to view the valve seating through the valve leaflets before and during tying of the suture knots. The presence of the anti-loop member 104 also prevents suture looping as the suture knots are being tied.

[0045] Once the heart valve 102 is sufficiently secured to the valve annulus 142, the anti-loop member 104 can be removed. In one embodiment (see FIG. 5C), the first end portion 116 of the anti-loop member 104 passes through the sewing ring 106 at a location next to a low point 148 of a cusp of one of the commissures 108. Having the first end portion exit through the sewing ring at a distance away from the last commissure will reduce stress on the commissure during removal of the anti-loop member.

[0046] With reference to FIGS. 6A-6E, a surgeon may grasp the first end portion 116 of the anti-loop member 104 with a forceps 150 at the inflow side of the valve annulus. Pulling on the anti-loop member will cause the second end portion 118 to unwind through the commissure posts 108 on the outflow side of the heart valve, and finally through the sewing ring 106, releasing the anti-loop member from the heart valve. The first end portion of the anti-loop member can be provided with an indicator to alert the surgeon to grab the end of the coil. The indicator can be in vivid colors or other eye-catching device to contrast it from the environment to prevent it from being left behind after completion of valve implantation.

[0047] In a further embodiment, the prosthetic heart valve system includes a valve holder and a handle. With reference to FIG. 7, the prosthetic heart valve 102 and anti-loop member 104 are secured to a valve holder 150 and a handle 152. The holder includes a central disk portion 154 and three arms 156 equally spaced around and extending away from the disk portion 154. Each arm 156 has a free end portion and a recess 160 provided in a top side of the free end portion. In the recess 160 is a pair of holes 162 through the arm to permit attachment of the holder to the heart valve 102 by a suture 164 passing through the holes. The recess also extends axially and has a deeper portion 166 to permit access for a cutting tool for cutting the suture.

[0048] The holder also includes a central post 170 that protrudes axially in a proximal direction. The central post 170 has a threaded opening (not shown) to receive the handle 152, which also has cooperative threading for attaching the handle to the valve holder. The first end portion 116 of the anti-loop member 104 is optionally connected to the holder, e.g., by tying down to an arm 156 of the holder 150. Alternatively, the arm can be molded onto the free end of the coil, or other suitable means to secure the coil 104 to the holder 150.

[0049] As will be appreciated, the holder 150 can be removed from the heart valve by cutting the sutures 164. The sutures are tied to the holder and will be removed with the holder. Similarly, in this embodiment, the anti-loop member 104 is connected to the holder and will be removed with the holder. Alternatively, the anti-loop member is not connected to the holder and can be removed separately. After the heart valve is placed on the native valve annulus, the holder can be removed and the surgeon is provided a clear view to check on valve seating before and during tying of the suture knots, even when the anti-loop member is still present. The presence of the coil will prevent suture looping during the knot tying procedure. After all the suture knots are tied, the surgeon can easily pull the anti-loop member out by grabbing on the first end of the member.

[0050] In other alternative embodiments, various different features from the different embodiments discussed above can also be combined in a single modified ring holder.

[0051] For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.

[0052] Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0053] In view of the many possible embodiments to which the principles of the disclosure can 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 of the disclosure is defined by the following claims.