Valve prosthesis fixation techniques using sandwiching

• US 10,004,601 B2
• Filed: 10/31/2011
• Issued: 06/26/2018
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Kilemnik, Ido, Benary, Raphael
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/285,218
• Publication Number:
  US 20120046741A1
• Time in Patent Office: 2,430 Days
• Field of Search: 623 124- 126, 623 222- 226, 623 21, 623 217
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A prosthetic apparatus includes a main body having a lumen and configured for placement within a native annulus of a native valve complex. The main body is radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state. The apparatus also includes at least one arm coupled to and disposed outside of the main body. The arm being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the arm and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the arm, the space decreases to capture the leaflet between the outer surface of the main body and the arm.

Claims

1. A prosthetic apparatus for implanting at the native valve of a heart, the native valve having a native annulus and native valve leaflets, the prosthetic apparatus comprising:

a main body comprising a lumen and configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state;

at least one arm coupled to and disposed outside of the main body, the arm being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the arm and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the arm, the space decreases to capture the leaflet between the outer surface of the main body and the arm; and

a proximal portion extending radially outward from a proximal end of the main body, the proximal portion being configured to reduce leakage around the prosthetic apparatus.

2. The prosthetic apparatus of claim 1, wherein the arm comprises an elongate member having a first end portion attached to a first attachment portion of the main body and a second end portion, opposite the first end portion, attached to a second attachment portion of the main body, and wherein the first and second attachment portions are adjacent to a downstream end of the main body, and the elongate member further comprises an intermediate portion that extends from the first end portion to the second end portion and in a direction lengthwise of the main body, and wherein the leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

3. The prosthetic apparatus of claim 2, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

4. The prosthetic apparatus of claim 1, wherein the at least one arm comprises a plurality of arms that are spaced around the outside of the main body, and wherein the plurality of arms comprises a first arm and a second arm coupled to the main body, the first arm defining a first leaflet-receiving space for capturing a first native leaflet of the native valve between the first arm and the outer surface of the main body and the second arm defining a second leaflet-receiving space for capturing a second native leaflet of the native valve between the second arm and the outer surface of the main body.

5. The prosthetic apparatus of claim 1, further comprising a valve portion coupled to the inner surface of the main body, the valve portion comprising valve leaflets that form a one-way valve in the lumen.

6. The prosthetic apparatus of claim 1, wherein the arm is coupled to the main body such that in the absence of any radial inward forces on the arm, the arm can remain substantially stationary as the main body is radially expanded.

7. The prosthetic apparatus of claim 1, wherein the prosthetic apparatus is configured for implantation at the native mitral valve of the heart.

8. The prosthetic apparatus of claim 1, wherein the prosthetic apparatus is configured for implantation at the native aortic valve of the heart.

9. The prosthetic apparatus of claim 1, wherein the at least one arm comprises a distal portion that is secured to the main body adjacent a distal end of the main body, the at least one arm further comprising a free portion opposite the distal portion of the at least one arm that extends toward the proximal portion, the free portion of the at least one arm being spaced from the proximal portion such that the native valve leaflet extends between the free portion and the proximal portion when the native valve leaflet is in the leaflet-receiving space.

10. The prosthetic apparatus of claim 1, wherein the at least one arm is coupled to an arm attachment portion of the main body, and wherein the at least one arm is configured to self-expand to a radially extended state when released from a delivery sheath while the arm attachment portion of the main body is retained in the radially compressed state by the delivery sheath.

11. The prosthetic apparatus of claim 10, wherein the at least one arm is configured to self-expand to the radially extended state when released from a delivery sheath while the entire main body is retained in the radially compressed state by the delivery sheath.

12. The prosthetic apparatus of claim 1, wherein the at least one arm comprises an elongate member having a first end portion attached to a first attachment portion of the main body and a second end portion, opposite the first end portion, attached to a second attachment portion of the main body, wherein the first and second attachment portions are at a distal end of the main body, wherein the first and second end portions of the elongate member extend from the respective attachment portions in a proximal direction, wherein the elongate member further comprises an intermediate portion that extends from the first end portion and the second end portion and in a distal direction lengthwise of the main body, and wherein the leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

13. The prosthetic apparatus of claim 12, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

14. The prosthetic apparatus of claim 1, wherein the proximal portion is substantially frustoconical and extends from the proximal end of the main body radially outward and toward the distal end of the main body.

15. The prosthetic apparatus of claim 1, wherein the proximal portion comprises a graft covering that blocks blood from flowing beyond the proximal end of the main body outside the main body.

16. A prosthetic apparatus for implantation within a native cardiac valve of a heart, the native valve having a native annulus and native valve leaflets, the prosthetic apparatus comprising:

a tubular main body comprising a lumen and configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state, the main body comprising an inflow end and an outflow end;

a plurality of arms coupled to and disposed outside of the main body, the arms positioned to define a plurality of leaflet-receiving spaces between the arms and an outer surface of the main body for receiving native valve leaflets therebetween,

wherein each arm comprises a first portion that extends in a distal direction beyond the outflow end of the main body and a second portion that extends back toward the inflow end of the main body along a length of the main body; and

a proximal portion extending radially outward from a proximal end of the main body, the proximal portion being configured to reduce leakage around the prosthetic apparatus.

17. The prosthetic apparatus of claim 16, wherein the first portion of each arm is secured to the main body adjacent the outflow end of the main body, and the second portion of each arm comprises a free end portion opposite the first portion that extends toward the proximal portion, the free end portion of the arm being spaced from the proximal portion such that a corresponding native valve leaflet extends between the free end portion and the proximal portion when the native valve leaflet is captured in the leaflet-receiving space.

18. The prosthetic apparatus of claim 16, wherein each arm comprises an elongate member, wherein said first portion of the arm comprises first and second end portions of the elongate member, the first end portion being attached to a first attachment portion of the main body and the second end portion being attached to a second attachment portion of the main body, wherein the first and second attachment portions are at the outflow end of the main body, wherein the first and second end portions of the elongate member extend from the respective attachment portions in a distal direction beyond the outflow end of the main body, wherein said second portion of the arm comprises an intermediate portion of the elongate member that extends from the first end portion and the second end portion and in a proximal direction lengthwise of the main body, and wherein a respective leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

19. The prosthetic apparatus of claim 16, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

20. The prosthetic apparatus of claim 16, further comprising a valve portion coupled to the inner surface of the main body, the valve portion comprising valve leaflets that form a one-way valve in the lumen.

21. The prosthetic valve of claim 16, wherein the arms are configured to compress portions of the native leaflets between the arms and the main body.

22. The prosthetic valve of claim 16, wherein the proximal portion comprises a graft covering adapted to impede blood from flowing between the native valve and the main body when the prosthetic valve is implanted.

23. A prosthetic apparatus for implanting at the native valve of a heart, the native valve having a native annulus and native valve leaflets, the prosthetic apparatus comprising:

a main body comprising a lumen, a proximal portion, a distal portion, and a middle portion extending between the proximal portion and the distal portion, the middle portion configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state; and

at least one arm coupled to the distal portion and disposed outside of the main body, the arm being coupled to the main body such that when the main body is compressed to the compressed state, a leaflet-receiving space between the arm and an outer surface of the main body increases to receive a native valve leaflet therebetween, and when the main body expands to the expanded state in the absence of any radial inward forces on the main body or the arm, the space decreases to capture the leaflet between the outer surface of the main body and the arm;

wherein the proximal portion extends radially outward from the middle portion of the main body, the proximal portion being configured to reduce leakage around the prosthetic apparatus.

24. The prosthetic apparatus of claim 23, wherein the at least one arm comprises a plurality of arms that are spaced around the outside of the main body, and wherein the plurality of arms comprises a first arm and a second arm coupled to the main body, the first arm defining a first leaflet-receiving space for capturing a first native leaflet of the native valve between the first arm and the outer surface of the main body and the second arm defining a second leaflet-receiving space for capturing a second native leaflet of the native valve between the second arm and the outer surface of the main body.

25. The prosthetic apparatus of claim 23, further comprising a valve portion coupled to the inner surface of the main body, the valve portion comprising valve leaflets that form a one-way valve in the lumen.

26. The prosthetic apparatus of claim 23, wherein the arm is coupled to the main body such that in the absence of any radial inward forces on the arm, the arm can remain substantially stationary as the main body is radially expanded.

27. The prosthetic apparatus of claim 23, wherein the at least one arm comprises a distal portion that is secured to the main body adjacent a distal end of the main body, the at least one arm further comprising a free portion opposite the distal portion of the at least one arm that extends toward the proximal portion, the free portion of the at least one arm being spaced from the proximal portion such that the native valve leaflet extends between the free portion and the proximal portion when the native valve leaflet is in the leaflet-receiving space.

28. The prosthetic apparatus of claim 23, wherein the at least one arm is coupled to an arm attachment portion of the main body, and wherein the at least one arm is configured to self-expand to a radially extended state when released from a delivery sheath while the arm attachment portion of the main body is retained in the radially compressed state by the delivery sheath.

29. The prosthetic apparatus of claim 28, wherein the at least one arm is configured to self-expand to the radially extended state when released from a delivery sheath while the entire main body is retained in the radially compressed state by the delivery sheath.

30. The prosthetic apparatus of claim 23, wherein the at least one arm comprises an elongate member having a first end portion attached to a first attachment portion of the main body and a second end portion, opposite the first end portion, attached to a second attachment portion of the main body, wherein the first and second attachment portions are at a distal end of the main body, wherein the first and second end portions of the elongate member extend from the respective attachment portions in a proximal direction, wherein the elongate member further comprises an intermediate portion that extends from the first end portion and the second end portion and in a distal direction lengthwise of the main body, and wherein the leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

31. The prosthetic apparatus of claim 30, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

32. The prosthetic apparatus of claim 23, wherein the proximal portion is substantially frustoconical and extends from the proximal end of the main body radially outward and toward the distal end of the main body.

33. The prosthetic apparatus of claim 23, wherein the proximal portion comprises a graft covering that blocks blood from flowing beyond the proximal end of the main body outside the main body.

34. A prosthetic apparatus for implantation within a native cardiac valve of a heart, the native valve having a native annulus and native valve leaflets, the prosthetic apparatus comprising:

a tubular main body comprising a lumen, a proximal portion, a distal portion, and a middle portion extending between the proximal portion and the distal portion, the middle portion configured for placement within the native annulus, the main body being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state, the main body comprising an inflow end and an outflow end; and

a plurality of arms coupled to the distal portion and disposed outside of the main body, the arms positioned to define a plurality of leaflet-receiving spaces between the arms and an outer surface of the main body for receiving native valve leaflets therebetween,

wherein each arm comprises a first portion that extends in a distal direction beyond the outflow end of the main body and a second portion that extends back toward the inflow end of the main body along a length of the main body,

wherein the proximal portion extends radially outward from the middle portion of the main body, the proximal portion being configured to reduce leakage around the prosthetic apparatus.

35. The prosthetic apparatus of claim 34, wherein the first portion of each arm is secured to the main body adjacent the outflow end of the main body, and the second portion of each arm comprises a free end portion opposite the first portion that extends toward the proximal portion, the free end portion of the arm being spaced from the proximal portion such that a corresponding native valve leaflet extends between the free end portion and the proximal portion when the native valve leaflet is captured in the leaflet-receiving space.

36. The prosthetic apparatus of claim 34, wherein each arm comprises an elongate member, wherein said first portion of the arm comprises first and second end portions of the elongate member, the first end portion being attached to a first attachment portion of the main body and the second end portion being attached to a second attachment portion of the main body, wherein the first and second attachment portions are at the outflow end of the main body, wherein the first and second end portions of the elongate member extend from the respective attachment portions in a distal direction beyond the outflow end of the main body, wherein said second portion of the arm comprises an intermediate portion of the elongate member that extends from the first end portion and the second end portion and in a proximal direction lengthwise of the main body, and wherein a respective leaflet-receiving space is between the intermediate portion and the outer surface of the main body.

37. The prosthetic apparatus of claim 34, wherein the elongate member comprises a polygonal cross-sectional profile perpendicular to a length of the elongate member.

38. The prosthetic apparatus of claim 34, further comprising a valve portion coupled to the inner surface of the main body, the valve portion comprising valve leaflets that form a one-way valve in the lumen.

39. The prosthetic valve of claim 34, wherein the arms are configured to compress portions of the native leaflets between the arms and the main body.

40. The prosthetic valve of claim 34, wherein the proximal portion comprises a graft covering adapted to impede blood from flowing between the native valve and the main body when the prosthetic valve is implanted.