PROSTHETIC MITRAL VALVE WITH TISSUE ANCHORS

• US 20110224785A1
• Filed: 03/10/2011
• Published: 09/15/2011
• Est. Priority Date: 03/10/2010
• Status: Abandoned Application

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hacohen, Gil
• Application Number:
  US13/044,694
• Publication Number:
  US 20110224785A1
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Apparatus and methods are described including a prosthetic atrioventricular valve (10) for coupling to a native atrioventricular valve (12). The prosthetic valve includes a support frame (20) and a covering (22), which at least partially covers the support frame. The support frame and the covering are shaped so as to define a downstream skirt (24). A plurality of prosthetic leaflets (40) are coupled to at least one element selected from the group consisting of the support frame and the covering. An elongated anchoring member (152) is positioned around the downstream skirt in a subvalvular space (150), such that the anchoring member presses native leaflets (30) of the native valve against the downstream skirt, thereby anchoring the prosthetic valve to the native valve. Other applications are also described.

Claims

1. Apparatus comprising a prosthetic atrioventricular valve for coupling to a native atrioventricular valve, the prosthetic valve comprising:

a support frame;

a covering, which at least partially covers the support frame, wherein the support frame and the covering are shaped so as to define a downstream skirt;

a plurality of prosthetic leaflets, coupled to at least one element selected from the group consisting of;

the support frame and the covering; and

an elongated anchoring member, configured to be positioned around the downstream skirt in a subvalvular space, such that the anchoring member presses native leaflets of the native valve against the downstream skirt, thereby anchoring the prosthetic valve to the native valve.

2. The apparatus according to claim 1, wherein the elongated anchoring member is configured to be positioned completely around the downstream skirt.

3. The apparatus according to claim 1, wherein the prosthetic valve further comprises a contracting housing shaped so as to define a channel therethrough, wherein a first end of the anchoring member is fixed to the contracting housing, and wherein a second end of the anchoring member passes through the channel.

4. The apparatus according to claim 1, wherein the prosthetic valve is configured to assume collapsed and expanded states.

5. Apparatus comprising a prosthetic atrioventricular valve for coupling to a native atrioventricular valve, the prosthetic valve comprising:

a support frame;

a covering, which at least partially covers the support frame, wherein the support frame and the covering are shaped so as to define a downstream skirt;

a plurality of prosthetic leaflets, coupled to at least one element selected from the group consisting of;

the support frame and the covering; and

a plurality of subvalvular anchoring elements, coupled to the downstream skirt, and configured to anchor the prosthetic valve to the native valve by piercing native leaflets of the native valve, passing through to a subvalvular space, and applying a force against the ventricular surface of the native leaflets.

6. The apparatus according to claim 5, wherein the prosthetic valve is configured to assume collapsed and expanded states.

7. The apparatus according to claim 5, wherein each of the tissue coupling elements is shaped as an element selected from the group consisting of:

a hollow needle, a solid needle, a rod, and a rectangular plate.

8. The apparatus according to claim 5, wherein the tissue coupling elements are configured to assume a curved shape when in resting states.

9. The apparatus according to claim 5, wherein the tissue coupling elements are shaped so as to define respective barbs.

10. The apparatus according to claim 5, wherein the tissue coupling elements comprise needles.

11. The apparatus according to claim 10, wherein the needles are configured to assume curved shapes when in resting states.

12. The apparatus according to claim 11, wherein the needles are shaped so as to define respective lumens, and wherein the apparatus further comprises an implantation tool, which comprises a plurality of rigid rods initially positioned in the lumens, respectively, so as to at least partially straighten the needles.

13. The apparatus according to claim 11, wherein the needles comprise a shape memory alloy.

14-21. -21. (canceled)

22. A method comprising:

providing a prosthetic atrioventricular valve, which includes (a) a support frame, (b) a covering, which at least partially covers the support frame, wherein the support frame and the covering are shaped so as to define a downstream skirt, (c) a plurality of prosthetic leaflets, coupled to at least one element selected from the group consisting of;

the support frame and the covering, and (d) an elongated anchoring member;

placing the prosthetic valve at a native valve of a subject, such that the downstream skirt passes through an orifice of the native valve toward a ventricle of the subject; and

anchoring the prosthetic valve to the native valve by positioning the elongated anchoring member around the downstream skirt in a subvalvular space, such that the anchoring member presses native leaflets of the native valve against the downstream skirt.

23. The method according to claim 22, wherein positioning the elongated anchoring member comprises positioning the elongated anchoring member completely around the downstream skirt.

24. The method according to claim 22, wherein the prosthetic valve further includes a contracting housing shaped so as to define a channel therethrough, wherein a first end of the anchoring member is fixed to the contracting housing, and wherein a second end of the anchoring member passes through the channel, and wherein anchoring further comprises pulling on the second end of the anchoring member to tighten the anchoring member around the native leaflets.

25. The method according to claim 22, wherein placing the prosthetic valve comprises delivering the prosthetic valve to the native valve while the prosthetic valve is in a collapsed state in a catheter, and deploying the prosthetic valve from the catheter such that prosthetic valve assumes an expanded state.

26. A method comprising:

providing a prosthetic atrioventricular valve, which includes (a) a support frame, (b) a covering, which at least partially covers the support frame, wherein the support frame and the covering are shaped so as to define a downstream skirt, (c) a plurality of prosthetic leaflets, coupled to at least one element selected from the group consisting of;

the support frame and the covering, and (d) a plurality of subvalvular anchoring elements, coupled to the downstream skirt;

placing the prosthetic valve at a native valve of a subject, such that the downstream skirt passes through an orifice of the native valve toward a ventricle of the subject; and

anchoring the prosthetic valve to the native valve by causing the subvalvular anchoring elements to pierce native leaflets of the native valve, pass through to a subvalvular space, and apply a force against the ventricular surface of the native leaflets.

27. The method according to claim 26, wherein placing the prosthetic valve comprises delivering the prosthetic valve to the native valve while the prosthetic valve is in a collapsed state in a catheter, and deploying the prosthetic valve from the catheter such that the prosthetic valve assumes an expanded state.

28. The method according to claim 26, wherein each of the tissue coupling elements is shaped as an element selected from the group consisting of:

a hollow needle, a solid needle, a rod, and a rectangular plate.

29. The method according to claim 26, wherein the tissue coupling elements are configured to assume a curved shape when in resting states.

30. The method according to claim 26, wherein the tissue coupling elements are shaped so as to define respective barbs.

31. The method according to claim 26, wherein placing comprises placing the prosthetic valve such that the downstream skirt pushes aside and presses against the native leaflets.

32. The method according to claim 26, wherein the tissue coupling elements include needles.

33. The method according to claim 32, wherein the needles are configured to assume curved shapes when in resting states.

34. The method according to claim 33, wherein the needles are shaped so as to define respective lumens, and wherein anchoring comprises causing the subvalvular anchoring elements to pierce the native leaflets while a rigid rods are initially positioned in the lumens, respectively, so as to at least partially straighten the needles, and subsequently withdrawing the rods from the lumens.

35. The method according to claim 33, wherein the needles comprise a shape memory alloy.

36-45. -45. (canceled)