Mitral prosthesis and methods for implantation

• US 9,072,603 B2
• Filed: 10/28/2010
• Issued: 07/07/2015
• Est. Priority Date: 02/24/2010
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Hariton, Ilia, Kovalsky, Igor, Ben-Hamou, Eli
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/914,678
• Publication Number:
  US 20110208298A1
• Time in Patent Office: 1,713 Days
• Field of Search: 623/1.24, 623/1.31, 623/2.17, 623/1.26
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

Apparatus and methods are provided, including a mitral valve prosthesis for implantation at a native mitral valve complex of a subject. The prosthesis includes an inner support structure having a downstream section, and an upstream section, the upstream section having a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to apply an axial force directed toward a left ventricle. The prosthesis further includes an outer support structure having two or more engagement arms, the engagement arms being coupled to the inner support structure. The prosthesis is configured, upon implantation thereof, to clamp portions of leaflets of the native valve between the inner support structure and the engagement arms. Other embodiments are also described.

Claims

1. Apparatus comprising a mitral valve prosthesis for implantation at a native mitral valve complex of a subject, the prosthesis comprising:

an inner support structure having a downstream section, and an upstream section, wherein the upstream section has a cross-sectional area greater than the downstream section, the inner support structure being configured to be positioned at least partially on an atrial side of the native valve complex, and to apply an axial force directed toward a left ventricle; and

an outer support structure having two or more engagement arms, a first engagement arm having a first length and a second engagement arm directly opposite the first engagement arm having a second length longer than the first length, wherein the engagement arms are coupled to the inner support structure, and

wherein the first and second engagement arms are configured to clamp portions of leaflets of the native valve between the inner support structure and the engagement arms.

2. The apparatus according to claim 1, wherein the engagement arms are integrally formed with the inner support structure.

3. The apparatus according to claim 1, wherein the engagement arms comprise posterior and anterior engagement arms configured to clamp, respectively, posterior and anterior leaflets of the native mitral valve complex, and wherein a ratio of the length of the anterior engagement arm to the length of the posterior arm is between 1.1:

1 and 15;

1.

4. The apparatus according to claim 3, wherein the ratio is between 1.3:

1 and 2;

1.

5. The apparatus according to claim 3, wherein the length of the anterior engagement arm is between 2 mm and 35 mm.

6. The apparatus according to claim 5, wherein the length of the anterior engagement arm is between 15 mm and 25 mm.

7. The apparatus according to claim 3, wherein the length of the posterior engagement arm is between 2 mm and 35 mm.

8. The apparatus according to claim 7, wherein the length of the posterior engagement arm is between 7 mm and 23 mm.

9. The apparatus according to claim 1, wherein the outer support structure further comprises a connecting frame, the connecting frame of the outer support structure being configured to be coupled to the inner support structure.

10. The apparatus according to claim 9, wherein the inner support structure is shaped to define a plurality of cells, and wherein the connecting frame of the outer support structure is shaped to define a plurality of cells having shapes and sizes that match cells of the inner support structure.

11. The apparatus according to claim 1, wherein clamping of the leaflets reduces motion of the leaflets, by clamping portions of the leaflets between the inner support structure and the engagement arms.

12. The apparatus according to claim 11, wherein the prosthesis is configured to immobilize the native valve leaflets, by clamping the leaflets inside the engagement arms.

13. The apparatus according to claim 11, wherein the prosthesis is configured to prevent systolic anterior motion of the native valve leaflets, by clamping the leaflets inside the engagement arms.

14. The apparatus according to claim 11, wherein the prosthesis is configured to prevent the native leaflets from interfering with LVOT, by clamping the leaflets inside the engagement arms.

15. The apparatus according to claim 11, wherein the outer support structure further comprises covers for covering the engagement arms, the covers being configured to reduce the motion of the native leaflets.

16. The apparatus according to claim 1, further comprising a prosthetic valve that comprises prosthetic valve leaflets and that is coupled to the inner support structure, wherein the prosthesis is configured such that, upon implantation thereof:

downstream ends of native valve leaflets of the native mitral valve complex,

downstream ends of the engagement arms, and

downstream ends of the prosthetic leaflets,

are disposed at a longitudinal distance from one another of less than 3 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis.

17. The apparatus according to claim 16, wherein the downstream ends of the engagement arms are coupled to the inner support structure within 3 mm of a downstream end of the inner support structure.

18. The apparatus according to claim 16, wherein the prosthesis is configured such that, upon implantation thereof, no portion of the prosthesis protrudes into a left ventricle of the subject by more than 3 mm.

19. The apparatus according to claim 16, wherein the prosthesis is configured such that, upon implantation thereof:

the downstream ends of native valve leaflets of the native mitral valve complex,

the downstream ends of the engagement arms, and

the downstream ends of the prosthetic leaflets,

are disposed at a longitudinal distance from one another of less than 1 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis.

20. The apparatus according to claim 19, wherein the prosthesis is configured such that, upon implantation thereof, no portion of the prosthesis protrudes into a left ventricle of the subject by more than 1 mm.

21. The apparatus according to claim 19, wherein the downstream ends of the engagement arms are coupled to the inner support structure within 1 mm of a downstream end of the inner support structure.

22. The apparatus according to claim 1, wherein the engagement arms are configured to define first configurations thereof during implantation of the prosthesis, and to change shape so as to define second configurations thereof, subsequent to being placed over the native leaflets of the native mitral valve complex,

each of the engagement arms spanning a width of less than 12 mm in the first configuration thereof, and spanning a width of more than 15 mm when in the second configuration thereof.

23. The apparatus according to claim 22, wherein, in the first configuration thereof, the engagement arms are configured to facilitate functioning of the native valve complex during implantation of the prosthesis.

24. The apparatus according to claim 22, wherein, in the first configuration thereof, the engagement arms are configured to fit between papillary muscles of the native valve complex.

25. The apparatus according to claim 22, wherein, in the first configuration thereof, the engagement arms are configured to span a width of less than 8 mm.

26. The apparatus according to claim 22, wherein, in the second configuration thereof, the engagement arms are configured to span a width of more than 35 mm.

27. The apparatus according to claim 1,

further comprising a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure such that downstream ends of the prosthetic valve leaflets are within 3 mm of the downstream ends of the engagement arms,

wherein the engagement arms are coupled to the inner support structure at downstream ends of the engagement arms, and

wherein a longitudinal distance from a downstream end to an upstream end of each of the engagement arms is less than 18 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis.

28. The apparatus according to claim 27, wherein the prosthetic valve leaflets are coupled to the inner support structure such that downstream ends of the prosthetic valve leaflets are within 1 mm of the downstream ends of the engagement arms.

29. The apparatus according to claim 27, wherein the downstream ends of the engagement arms are coupled to the inner support structure within 3 mm of a downstream end of the inner support structure.

30. The apparatus according to claim 29, wherein the downstream ends of the engagement arms are coupled to the inner support structure within 1 mm of a downstream end of the inner support structure.

31. The apparatus according to claim 27, wherein the longitudinal distance from the downstream end to the upstream end of each of the engagement arms is less than 12 mm.

32. The apparatus according to claim 31, wherein the longitudinal distance from the downstream end to the upstream end of each of the engagement arms is less than 10 mm.

33. The apparatus according to claim 1, further comprising a prosthetic valve having prosthetic valve leaflets coupled to the inner support structure, the prosthesis being configured such that, upon implantation thereof:

downstream ends of native valve leaflets of the native mitral valve complex, and downstream ends of the engagement arms are disposed at a longitudinal distance from one another of less than 3 mm, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis, and

a downstream end of the inner support structure and downstream ends of the prosthetic valve leaflets are at a longitudinal distance of at least 4 mm upstream of the downstream ends of the native valve leaflets, the longitudinal distance being measured in a direction of a longitudinal axis of the prosthesis.

34. The apparatus according to claim 33, wherein the prosthesis is configured such that, upon implantation thereof, the downstream end of the inner support structure and the downstream ends of the prosthetic valve leaflets are at a longitudinal distance of at least 10 mm upstream of the downstream ends of the native valve leaflets.

35. The apparatus according to claim 1, further comprising a prosthetic valve having prosthetic valve leaflets, the prosthetic valve leaflets being coupled to the inner support structure such that downstream ends of the prosthetic valve leaflets are at least 4 mm upstream of the downstream ends of the engagement arms.

36. The apparatus according to claim 35, wherein the prosthetic valve leaflets are coupled to the inner support structure such that the downstream ends of the prosthetic valve leaflets are at least 10 mm upstream of the downstream ends of the engagement arms.