Prosthetic Mitral Valve and Delivery Method

• US 20140121763A1
• Filed: 10/31/2012
• Published: 05/01/2014
• Est. Priority Date: 10/31/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Duffy, Niall, Gavin, Kenny, Bartolozzi, Fabio
• Granted Patent: US 9,023,099 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Claims

1. A mitral valve prosthesis comprising:

a) an expandable inflow region formed of a plurality of cells and configured to expand within and support against the walls of the left atrium, wherein the expandable inflow region has a cross-sectional diameter larger than the annulus of the native mitral valve;

b) an expandable outflow region formed of a plurality of cells and configured to expand within and support against the native mitral valve annulus, wherein the expandable outflow region comprises;

i) two or more engagement arms; and

ii) at least two anchor attachment points; and

c) a prosthetic valve.

2. The mitral valve prosthesis of claim 1, wherein each anchor attachment point is attached to a proximal end of one or more anchor.

3. The mitral valve prosthesis of claim 2, wherein the anchor comprises a biocompatible material.

4. The mitral valve prosthesis of claim 2, wherein a distal end of each anchor is further attached to an anchoring element.

5. The mitral valve prosthesis of claim 4, wherein the anchoring element is a hook.

6. The mitral valve prosthesis of claim 4, wherein the anchoring element is a clip.

7. The mitral valve prosthesis of claim 4, wherein the anchoring element can be adjusted to adjust tension on the anchor.

8. The mitral valve prosthesis of claim 4, wherein the anchoring element is configured to attach to the wall of the left ventricle.

9. The mitral valve prosthesis of claim 4, wherein the anchoring element is configured to attach to a papillary muscle of the heart.

10. The mitral valve prosthesis of claim 2, wherein the anchor is configured to function as an artificial chordae.

11. The mitral valve prosthesis of claim 10, wherein a distal end of the anchor is sutured to a papillary muscle of the heart.

12. The mitral valve prosthesis of claim 3, wherein the biocompatible material is linearly elastic.

13. The mitral valve prosthesis of claim 3, wherein the biocompatible material is viscoelastic.

14. The mitral valve prosthesis of claim 1, wherein the expandable outflow region further comprises at least two commissural sealing members.

15. The mitral valve prosthesis of claim 14, wherein the commissural sealing members extend at an angle of about 90 degrees to the engagement arms.

16. The mitral valve prosthesis of claim 14, wherein the commissural sealing members are configured to seal native commissures of the heart and prevent peri-valvular leakage (PVL).

17. The mitral valve prosthesis of claim 1, wherein the prosthetic valve is sutured to the expandable inflow region.

18. The mitral valve prosthesis of claim 1, wherein the anchor attachment points comprise two or more eyelets.

19. The mitral valve prosthesis of claim 1, wherein the expandable outflow region further comprises two or more commissure posts, wherein ends of the engagement arms are each coupled to one of the commissure posts.

20. A method of treating a mitral valve disorder in a patient'"'"'s heart, comprising:

a) inserting a delivery device into the left ventricle of the heart;

b) advancing a mitral valve prosthesis via the delivery device into the left ventricle of the heart, wherein the mitral valve prosthesis comprises;

1) an expandable inflow region formed of a plurality of cells and configured to expand within and support against the walls of the left atrium, wherein the expandable inflow region has a cross-sectional diameter larger than the annulus of the native mitral valve;

2) an expandable outflow region formed of a plurality of cells and configured to expand within and support against the native mitral valve annulus, wherein the expandable outflow region comprises;

i) two or more engagement arms; and

ii) at least two anchor attachment points; and

3) a prosthetic valve;

c) advancing the delivery device into the native mitral valve such that the engagement arms seat on the outer surface of the native mitral valve leaflets;

d) attaching the mitral valve prosthesis to the heart via at least one anchor; and

e) adjusting tension on the anchor to prevent PVL.

21. The method of claim 20, wherein at least one anchor attachment point is attached to a proximal end of at least one anchor prior to (b).

22. The method of claim 21, wherein a distal end of the anchor is attached to the heart.

23. The method of claim 22, wherein the anchor is attached to the heart via an anchoring element.

24. The method of claim 21, wherein the anchor is sutured to the heart.

25. The method of claim 23, wherein the anchoring element is a hook.

26. The method of claim 23, wherein the anchoring element is a clip.

27. The method of claim 23, wherein the anchoring element is configured to attach to the wall of the left ventricle.

28. The method of claim 23, wherein the anchoring element is configured to attach to a papillary muscle of the heart.

29. The method of claim 20, wherein a distal end of at least one anchor is attached to the heart prior to (b).

30. The method of claim 29, wherein a proximal end of the anchor is attached to the anchor attachment point on the mitral valve prosthesis.

31. The method of claim 29, wherein the anchor is sutured to the heart.

32. The method of claim 29, wherein the anchor is attached to the heart via an anchoring element.

33. The method of claim 32, wherein the anchoring element is a hook.

34. The method of claim 32, wherein the anchoring element is a clip.

35. The method of claim 32, wherein the anchoring element is configured to attach to the wall of the left ventricle.

36. The method of claim 32, wherein the anchoring element is configured to attach to a papillary muscle of the heart.

37. The method of claim 20, wherein the anchor comprises a biocompatible material.

38. The method of claim 20, wherein the anchor is configured to function as an artificial chordae.

39. The method of claim 20, wherein the expandable outflow region further comprises at least two commissural sealing members.

40. The method of claim 20, wherein the expandable outflow region further comprises two or more commissure posts, wherein ends of the engagement arms are each coupled to one of the commissure posts.

41. The method of claim 20, wherein the delivery device is inserted transfemorally into the left ventricle of the heart.

42. The method of claim 20, wherein the delivery device is inserted transseptally into the left ventricle of the heart.

43. The method of claim 20, wherein the delivery device is inserted transapically into the left ventricle of the heart.