Apparatus and method for supporting a heart valve

• US 6,264,691 B1
• Filed: 04/23/1999
• Issued: 07/24/2001
• Est. Priority Date: 04/23/1999
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/298,493
• Time in Patent Office: 823 Days
• Field of Search: 623/2.38, 623/2.39, 623/2.4, 623/2-2-, 623/900, 623/904, 600/37
• US Class Current: 623/2.14
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/904 Heart

Abstract

An apparatus and method are disclosed for supporting a heart valve with a flexible girdle. The girdle has an elongated cylindrical sidewall having an axial length at least commensurate with the heart valve. The girdle is disposed around a tubular valve wall of the heart valve being implanted so that the inflow end of the girdle is adjacent the inflow end of the tubular valve wall. The inflow ends of the girdle and heart valve may then be sutured together to implant the valve. The girdle provides support to stabilize the heart valve and inhibit deformation thereof.

Claims

1. A external support apparatus for supporting a heart valve disposed within an elongated tubular valve wall, the apparatus comprising:

a girdle having an elongated sidewall with inflow and outflow ends spaced apart an axial length at least subtantially commensurate with axial length of the valve leaflets of the heart valve;

a stent disposed about the sidewall of the girdle intermediate the inflow and outflow ends of the sidewall of the girdle; and

a sheath of biocompatible material covering the stent and at least a portion of the girdle, the sheath having an inflow edge adjacent the inflow end of the sidewall of the girdle, the sheath having an outflow edge spaced axially beyond an outflow end of the stent.

2. An apparatus as set forth in claim 1 wherein a sinus is defined by each valve leaflet at an outflow end of the heart valve, said girdle further including at least two apertures extending through said sidewall of said girdle spaced axially from the inflow end of said girdle, each of said apertures being spaced circumferentially apart for generally radial alignment with a corresponding one of the sinuses of the heart valve.

3. An apparatus as set forth in claim 1 wherein a portion of said sidewall of said girdle adjacent said inflow end is folded toward the outflow end of said girdle and connected to said sidewall of said girdle, whereby the folded portion may be connected at an inflow end of the heart valve to inhibit dilation of the heart valve.

4. An apparatus as set forth in claim 3 wherein a sinus is defined by each valve leaflet at an outflow end of the heart valve, said girdle further including at least two apertures extending through said sidewall of said girdle spaced axially from the inflow end of said girdle, each of said apertures being spaced circumferentially apart for generally radial alignment with a corresponding one of the sinuses of the heart valve.

5. An apparatus as set forth in claim 1 wherein the outflow edge of said sheath is connected to said sidewall of said girdle intermediate the outflow end of said stent and the outflow end of said girdle.

6. An apparatus as set forth in claim 1 wherein said sheath is formed of an animal tissue material.

7. An apparatus as set forth in claim 1 wherein said sheath is formed of a textile material.

8. An apparatus as set forth in claim 1 wherein the outflow end of said girdle has a plurality of lobes which extend axially beyond said outflow end of said stent so as to extend beyond an outflow end of the heart valve.

9. An apparatus as set forth in claim 1 wherein said girdle is formed of an animal tissue material.

10. An apparatus as set forth in claim 1 wherein said girdle is formed of a textile material.

11. An apparatus as set forth in claim 1 wherein said girdle is formed of a plastic-like material.

12. An apparatus as set forth in claim 1 wherein said girdle is formed of an absorbable material so as to permit growth of the heart valve after being implanted.

13. An external support apparatus for a heart valve disposed within a tubular valve wall, the heart valve extending an axial length within the tubular valve wall, the apparatus comprising:

an elongated cylindrical inner sheath of a biocompatible material having spaced apart inflow and outflow edges; and

a flexible stent disposed externally about the inner sheath, the stent having inflow and outflow ends spaced respectively from and intermediate the inflow and outflow edges of the inner sheath, the inner sheath having an outflow portion that extends beyond the outflow end of the stent a length sufficient to extend beyond an outflow end of the heart valve.

14. An apparatus as set forth in claim 13 further including an outer sheath of natural tissue covering said stent and at least a portion of said inner sheath, said outer sheath having an inflow end adjacent the inflow edge of said inner sheath, said outer sheath having an outflow end spaced axially from the outflow end of said stent.

15. An apparatus as set forth in claim 14 wherein the outflow end of said outer sheath is connected to said inner sheath intermediate the outflow end of said stent and the outflow edge of said inner sheath.

16. An apparatus as set forth in claim 14 wherein said outer sheath is formed of a textile material.

17. An apparatus as set forth in claim 14 wherein said outer sheath is formed of a biological material.

18. An apparatus as set forth in claim 13 wherein said stent has a sinusoidal outflow end with alternating peaks and sinuses corresponding to the contour of the outflow end of the heart valve.

19. An apparatus as set forth in claim 18 wherein each peak of said stent is defined by a stent post, each of said stent posts being circumferentially spaced apart so as to align with commissures of adjacent leaflets of the heart valve.

20. An apparatus as set forth in claim 13 wherein said inner sheath is formed of a biological material.

21. An apparatus as set forth in claim 13 wherein said inner sheath is formed of a textile material.

22. An apparatus as set forth in claim 13 wherein said inner sheath is formed of a plastic-like material.

23. An apparatus as set forth in claim 13 wherein the outflow portion of said inner sheath has a plurality of lobes which extend axially beyond the outflow end of said stent.

24. An apparatus as set forth in claim 13 wherein the outflow portion further comprises a substantially tubular portion which extends beyond the outflow end of the stent an axial length sufficient to extend beyond the outflow end of the heart valve.

25. An apparatus as set forth in claim 24 wherein at least two apertures are formed though the tubular portion of said inner sheath, each of said apertures being spaced circumferentially apart for generally radial alignment with a corresponding sinus of the heart valve.

26. An apparatus as set forth in claim 13 wherein said inner sheath and stent are each formed of an absorbable material, whereby the growth of the heart valve is permitted after being implanted.

27. An external support apparatus for a heart valve disposed within a tubular valve wall, the heart valve extending an axial length within the tubular valve wall, the apparatus comprising:

an elongated cylindrical inner sheath of a flexible material aving spaced apart inflow and outflow ends; and

a flexible stent disposed externally about the inner sheath, the stent having inflow and outflow ends spaced respectively from the inflow and outflow ends of the inner sheath so that at least a substantial length of the outflow end of the inner sheath extends beyond the outflow end of the stent;

wherein the outflow end of the inner sheath has a generally tubular portion that extends beyond the outflow end of the stent, the tubular portion of the inner sheath having an axial length sufficient to extend beyond an outflow end of the heart valve, at least two apertures being formed through the tubular portion of the inner sheath, each of the apertures being spaced circumferentially apart for generally radial alignment with a corresponding sinus of the heart valve.

28. A method for implanting an autogenous or homogenous heart valve disposed within a length of a tubular valve wall having first and second ends, the heart valve having inflow and outflow ends spaced axially from the respective first and second ends of the tubular valve wall, said method comprising the steps of:

providing the heart valve disposed within the tubular valve wall;

disposing an elongated girdle externally about the tubular valve wall at least substantially coextensive with the heart valve to support the heart valve and inhibit deformation thereof, the girdle having a cylindrical sidewall with inflow and outflow ends spaced apart an axial length at least substantially commensurate with the axial length of the heart valve disposed within the tubular valve wall, the inflow end of the girdle being adjacent the first end of the tubular valve wall, the girdle having a generally tubular portion at the outflow end thereof having an axial length sufficient to extend beyond the outflow end of the heart valve.

29. A method as set forth in claim 28 wherein, prior to said step of disposing, at least two apertures are formed through the sidewall of the girdle at a location spaced axially from the inflow end of the girdle, each of the apertures being spaced apart circumferentially for substantially radial alignment with a corresponding sinus of the heart valve.

30. A method as set forth in claim 28 further including the step of forming at least two circumferentially spaced apart apertures through the sidewall of the girdle, each aperture being radially aligned with a sinus of the heart valve.

31. A method as set forth in claim 28 wherein said step of providing further includes removing the heart valve from a patient to define an autogeneous heart valve.

32. A method as set forth in claim 31 wherein after said step of disposing, the method further includes the step of implanting the supported heart valve in the patient from which it had been removed.

33. A method as set forth in claim 32 wherein said step of implanting includes connecting both the inflow end of the girdle and the first end of the tubular valve wall portion to an annulus of the patient'"'"'s heart, whereby the implanted heart valve is supported by the girdle.

34. A method as set forth in claim 28 wherein the girdle is formed of a textile material.

35. A method as set forth in claim 28 wherein the girdle is formed of an animal tissue material.

36. A method as set forth in claim 28 wherein the girdle is formed of a plastic-like material.

37. A method as set forth in claim 28 wherein the inflow end of the girdle is folded toward the outflow end of the girdle and connected to the sidewall of the girdle so as to provide at least two overlapping layers of the girdle sidewall at the inflow end of the girdle.

38. A method as set forth in claim 28 wherein the girdle further includes a stent disposed about the sidewall of the girdle intermediate the inflow and outflow ends of the girdle.

39. A method as set forth in claim 38 wherein the stent and at least a portion of the sidewall of the girdle are covered with a sheath of flexible biocompatible material, the sheath having an inflow end adjacent the inflow end of the girdle, the sheath having an outflow end connected with the sidewall of the girdle intermediate an outflow end of the stent and the outflow end of the sidewall of the girdle.

40. A method as set forth in claim 39 wherein the tubular outflow portion of the girdle has a plurality of circumferentially spaced apart lobes extending beyond the outflow end of the heart valve proximal the second end of the tubular valve wall.

41. A method as set forth in claim 28 wherein the girdle is formed of an absorbable material so as to permit growth of the heart valve and tubular valve wall after being implanted.

42. An external support apparatus for supporting a heart valve disposed within an elongated tubular valve wall, the apparatus comprising:

a girdle having an elongated sidewall with inflow and outflow ends space apart an axial length at least substantially commensurate with the axial length of valve leaflets of the heart valve, wherein the outflow end of the girdle has a plurality of circumferentially spaced apart lobes that extend axially therefrom a length sufficient to extend beyond an outflow end of the heart valve.

43. The apparatus of claim 42 further comprising a stent disposed about the sidewall of the girdle intermediate the inflow and outflow ends of the sidewall of the girdle.

44. The apparatus of claim 43 further comprising a sheath of biocompatible material covering the stent and at least a portion of the girdle, the sheath having an inflow end adjacent the inflow end of the sidewall of the girdle, the sheath having an outflow end spaced axially from an outflow end of the stent, the plurality of lobes extending axially beyond the outflow end of the sheath.