Low invasive implantable cardiac prosthesis and method for helping improve operation of a heart valve

• US 6,869,444 B2
• Filed: 08/09/2002
• Issued: 03/22/2005
• Est. Priority Date: 05/22/2000
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): BARRETT, THOMAS C
• Application Number:
  US10/215,800
• Publication Number:
  US 20030199975A1
• Time in Patent Office: 956 Days
• Field of Search: 623 211- 239
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An apparatus for helping improve operation of a heart valve includes a generally arcuate base and a buttress extending generally from at least a portion of the base. The apparatus can be deformable to facilitate its implantation. When the apparatus is when implanted at an annulus of a heart valve, the buttress thereof cooperates with one or more leaflets of the heart valve to help control blood flow relative to the apparatus and heart valve.

Claims

1. An apparatus for helping improve operation of a heart valve, comprising:

a generally arcuate base portion; and

a buttress extending from the base portion generally axially and inwardly relative to the base portion so as to permit substantially bi-directional flow of fluid relative to the apparatus, a surface of the buttress being dimensioned and configured to simulate a leaflet at systole that is to be engaged by at least one leaflet of the heart valve when the apparatus is implanted at the heart valve,

the base portion and the buttress being configured to provide a cross-sectional dimension that is variable between a reduced cross-sectional dimension to facilitate implantation thereof and an expanded cross-sectional dimension that helps maintain a desired position of the apparatus when implanted at the heart valve, whereby substantially unidirectional flow of blood is provided when the apparatus is implanted at the heart valve.

2. The apparatus of claim 1, the base portion further comprising a generally C-shaped base portion having a curved length between opposed ends of the C-shaped base portion, the buttress extending from an arc portion of the C-shaped base portion intermediate the opposed ends thereof.

3. The apparatus of claim 2, the buttress extending a first length in a direction radially inwardly and axially from the base portion and then curving outwardly for a second length to terminate in a distal end thereof.

4. The apparatus of claim 1, the arcuate base portion further comprising an annular ring and an aperture extends through the apparatus between the buttress and an opposed side of the annular base portion so as to permit substantially bi-directional flow of fluid axially relative to the apparatus.

5. The apparatus of claim 1, further comprising an outer sheath of a substantially flexible material covering at least the surface of the buttress.

6. The apparatus of claim 5, the outer sheath completely covering the buttress and the base portion.

7. The apparatus of claim 6, wherein the flexible material comprises a substantially biocompatible animal tissue material.

8. The apparatus of claim 7, the biocompatible animal tissue material comprises animal pericardium.

9. The apparatus of claim 6, further comprising a plurality of features extending through the outer sheath generally radially from the base portion to help maintain the apparatus at a desired position relative to the heart valve when implanted.

10. The apparatus of claim 1, the base portion being formed of a shape memory alloy material operative to urge the prosthesis to the expanded cross-sectional dimension.

11. The apparatus of claim 10, the buttress further being formed of the shape memory alloy material.

12. The apparatus of claim 1, further comprising features that extend outwardly from the base portion to help maintain the apparatus at a desired position and orientation relative to the heart valve when implanted.

13. The apparatus of claim 12, the base portion being formed of a mesh material with triangular projections at the inflow and outflow ends of the base portion, the triangular projections extending outwardly from the base portion to define the features.

14. The apparatus of claim 12, the features extending different lengths from the base portion according to their relative position along the base portion.

15. The prosthesis of claim 1, in combination with a retaining member to retain the apparatus in the reduced cross-sectional condition.

16. The apparatus of claim 15, wherein the retaining member includes a barrel in which at least a substantial portion of the apparatus is disposed to maintain the apparatus in the reduced cross-sectional condition.

17. The apparatus of claim 16, wherein the barrel comprises part of a catheter system adapted to position an opening of the barrel at a desired position and to discharge the prosthesis from the enclosure, such that the apparatus expands toward the expanded cross-sectional condition.

18. The apparatus of claim 1 in combination with an implanter, the combination comprising:

the implanter comprising an elongated generally cylindrical barrel dimensioned and configured to receive the apparatus when in the reduced cross-sectional condition; and

the apparatus being disposed within the cylindrical barrel, such that an inner sidewall of the cylindrical barrel maintains the prosthesis in the second condition.

19. The appartus of claim 18, wherein the implanter further comprises a plunger operative to move within the cylindrical barrel and urge the apparatus out of the cylindrical barrel, the apparatus being configured to expand from the reduced cross-sectional condition to the first condition when discharged from the cylindrical barrel.

20. An apparatus for helping improve operation of a heart valve, comprising:

a frame comprising a generally arcuate base portion and a support portion extending from the base portion generally axially and inwardly so as to permit substantially bi-directional flow of fluid relative to the apparatus, the support portion terminating at a distal end spaced from the base portion, the frame being formed of a material that enables a cross-sectional dimension of the apparatus to be variable between a reduced cross-sectional dimension, which facilitates implantation of the apparatus, and an expanded cross-sectional dimension that helps maintain the apparatus at a desired position when the apparatus is implanted at the heart valve; and

a web of a substantially flexible material extending from an arc of the base portion and supported by the support portion of the frame to define a buttress dimensioned and configured to simulate a leaflet at systole that is to be engaged by at least one leaflet of the heart valve, whereby, when the apparatus is implanted at the heart valve, at least one leaflet of the heart valve is moveable relative to a surface of the web so as to provide for substantially unidirectional blood flow relative to the apparatus.

21. The apparatus of claim 20, the base portion further comprises a generally C-shaped base portion having a curved length between opposed ends of the C-shaped base portion, the buttress extending from an arc portion of the C-shaped base portion intermediate the opposed ends thereof.

22. The apparatus of claim 20, the base portion further comprises ring and an aperture extends through the apparatus between the buttress and an opposed side of the annular base portion.

23. The apparatus of claim 20, the web of flexible material further comprising a substantially biocompatible animal tissue.

24. The apparatus of claim 23, wherein the biocompatible animal tissue is animal pericardium.

25. The apparatus of claim 20, the frame further comprising a mesh material that is deformable to the reduced cross-sectional condition and expandable to the expanded cross-sectional condition.

26. The apparatus of claim 25, the mesh material further comprising material having shape memory properties.

27. An apparatus for helping improve operation of a defective heart valve having at least one viable leaflet, comprising:

means for supporting an annulus of the heart valve so as to permit bi-directional blood flow through the support means, the support means being deformable to a reduced cross-sectional condition and expandable from the reduced cross-sectional condition to an expanded cross-sectional condition; and

means for simulating a leaflet at systole and for substantially coapting with the at least one leaflet of the heart valve when the apparatus is attached at the annulus of the heart valve, such that the at least one leaflet is moveable into and out of engagement with the means for substantially coapting to provide for substantially unidirectional blood flow relative to the apparatus, the means for simulating extending from the means for supporting.

28. The apparatus of claim 27, further comprising means for helping maintain the position of the apparatus relative to the heart valve, the means for helping extending from the support means.

29. A method for helping improve operation of a patient'"'"'s heart valve, comprising:

positioning an apparatus within a barrel so as to have a reduced cross-sectional condition, the apparatus comprising a base portion and a support extending from at least a portion of the base;

urging the apparatus from the barrel to implant the apparatus at the patient'"'"'s heart valve;

expanding the apparatus to an expanded condition at the patient'"'"'s heart valve, such that the apparatus simulates a leaflet at systole, such that at least one leaflet of the patient'"'"'s heart valve is moveable into and out of engagement with the apparatus to provide for substantially unidirectional flow of blood.

30. The method of claim 29, wherein prior to urging the apparatus from the barrel, the method further comprises navigating the barrel to a location near an annulus of the patient'"'"'s heart valve.

31. The method of claim 29, the expansion of the apparatus occurring in response to a stimulus or automatically upon urging the apparatus from the barrel.