Method of implanting a self-molding annuloplasty ring

• US 7,063,722 B2
• Filed: 02/12/2004
• Issued: 06/20/2006
• Est. Priority Date: 08/24/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Marquez, Salvador
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US10/777,343
• Publication Number:
  US 20040162611A1
• Time in Patent Office: 859 Days
• Field of Search: 623/2.36, 623/2.37, 623/2.11, 623/902
• 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 2/2448 D-shaped rings
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

A method of implanting a resilient self-molding annuloplasty ring including stretching it to an expanded diameter and attaching it to a heart valve annulus, then permitting the ring to contract to reduce the diameter of the annulus. The ring may be positioned on an insertion device that maintains the ring in its expanded diameter while attaching to the annulus. The resilient self molding annuloplasty ring which may be enlarged prior to implantation to facilitate implantation within a dilated or otherwise incompetent valve annulus having sufficient contractive force to render a valve competent. The self molding annuloplasty ring of the invention may further comprise integral attachment devices to aid in the implantation process.

Claims

1. A method of implanting an annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

maintaining the annuloplasty ring at its expanded diameter while attaching the annuloplasty ring to the dilated heart valve annulus by using an attachment device to physically connect the annuloplasty ring to the annulus; and

permitting the annuloplasty ring in contract inward from its expanded diameter so as to decrease the size of the attached heart valve annulus.

2. The method of claim 1, wherein the resilient annuloplasty ring comprises a resilient inner sizing member and an outer attachment sheath enclosing the sizing member.

3. The method of claim 2, wherein the attachment device comprises a plurality of members positioned on the annuloplasty ring.

4. The method of claim 3, wherein the plurality of members is selected from the group consisting of:

needles,

barbs, and

hooks.

5. The method of claim 3, wherein the material of the plurality of members is selected from the group consisting of:

stainless steel,

titanium, and

a nickel-titanium alloy.

6. The method of claim 2, wherein the attachment device comprises at least one suture, and wherein the step of attaching the annuloplasty ring to the dilated heart valve annulus comprises passing the suture through the attachment sheath and through the heart valve annulus.

7. The method of claim 2, wherein said outer attachment sheath is selected from the group consisting of:

biologically compatible fabric mesh,

polyethylene terephthalate,

polyester knit,

PTFE knit, and

ePTFE knit.

8. The method of claim 2, wherein said outer attachment sheath comprises a medicament to induce tissue growth.

9. The method of claim 1, wherein the annuloplasty ring further includes a resilient sizing member having a relaxed diameter, and wherein the method further comprises limiting contraction of the annuloplasty ring to a contracted diameter that is larger than the relaxed diameter of the resilient sizing member.

10. The method of claim 9, wherein the annuloplasty ring includes a series of support members positioned on the sizing member, and wherein the step of limiting contraction is accomplished by engagement of the support members with one another.

11. The method of claim 10, wherein each support member comprises a body member having a lumen formed therein, said lumen being capable of receiving the sizing member therein.

12. The method of claim 2, wherein said resilient sizing member comprises a biologically compatible elastomer.

13. The method of claim 1, wherein the step of maintaining the annuloplasty ring at its expanded diameter comprises positioning the annuloplasty ring on an insertion device.

14. The method of claim 13, wherein the annuloplasty ring is positioned on the insertion device at the time of manufacture.

15. The method of claim 13, wherein the annuloplasty ring is positioned on the insertion device immediately prior to implantation.

16. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member having a relaxed diameter and an outer attachment sheath;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus by using an attachment device to physically connect the attachment sheath to the annulus; and

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus.

17. The method of claim 16, wherein the attachment device comprises a plurality of members positioned on the annuloplasty ring.

18. The method of claim 17, wherein the plurality of members is selected from the group consisting of:

needles

barbs, and

hooks.

19. The method of claim 17, wherein the material of the plurality of members is selected from the group consisting of:

stainless steel,

titanium, and

a nickel-titanium alloy.

20. The method of claim 16, wherein the attachment device comprises at least one suture, and wherein the step of attaching the annuloplasty ring to the dilated heart valve annulus comprises passing the suture through the attachment sheath and through the heart valve annulus.

21. The method of claim 16, wherein said outer attachment sheath is selected from the group consisting of:

biologically compatible fabric mesh,

polyethylene terephthalate,

polyester knit,

PTFE knit, and

ePTFE knit.

22. The method of claim 16, wherein said outer attachment sheath comprises a medicament to induce tissue growth.

23. The method of claim 16, wherein the method further comprises limiting contraction of the annuloplasty ring to a contracted diameter that is larger than the relaxed diameter of the inner sizing member.

24. The method of claim 23, wherein the annuloplasty ring further includes a series of support members positioned on the inner sizing member, and wherein the step of limiting contraction is accomplished by engagement of the support members with one another.

25. The method of claim 24, wherein each support member comprises a body member having a lumen formed therein, said lumen being capable of receiving the sizing member therein.

26. The method of claim 16, wherein said resilient inner sizing member comprises a biologically compatible elastomer.

27. The method of claim 16, wherein the annuloplasty ring is positioned on the insertion device at the time of manufacture.

28. The method of claim 16, wherein the annuloplasty ring is positioned on the insertion device immediately prior to implantation.

29. A method of implanting an annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter and a resilient sizing member having a relaxed diameter;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

maintaining the annuloplasty ring at its expanded diameter while attaching the annuloplasty ring to the dilated heart valve annulus;

permitting the annuloplasty ring to contract inward from its expanded diameter so as to decrease the size of the attached heart valve annulus; and

limiting contraction of the annuloplasty ring to a contracted diameter that is larger than the relaxed diameter of the sizing member.

30. The method of claim 29, wherein the annuloplasty ring includes a series of support members positioned on the sizing member, and wherein the step of limiting contraction is accomplished by engagement of the support members with one another.

31. The method of claim 30, wherein each support member comprises a body member having a lumen formed therein, said lumen being capable of receiving the sizing member therein.

32. A method of implanting an annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

maintaining the annuloplasty ring at its expanded diameter while attaching the annuloplasty ring to the dilated heart valve annulus, wherein the annuloplasty ring is maintained at its expanded diameter by positioning the annuloplasty ring on an insertion device at the time of manufacture; and

permitting the annuloplasty ring to contract inward from its expanded diameter so as to decrease the size of the attached heart valve annulus.

33. A method of implanting an annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

maintaining the annuloplasty ring at its expanded diameter while attaching the annuloplasty ring to the dilated heart valve annulus, wherein the annuloplasty ring is maintained at its expanded diameter by positioning the annuloplasty ring on an insertion device immediately prior to implantation; and

permitting the annuloplasty ring to contract inward from its expanded diameter so as to decrease the size of the attached heart valve annulus.

34. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member and an outer attachment sheath, wherein said outer attachment sheath is selected from the group consisting of;

biologically compatible fabric mesh,

polyethylene terephthalate,

polyester knit,

PTFE knit, and

ePTFE knit;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus; and

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus.

35. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member and an outer attachment sheath, wherein said outer attachment sheath comprises a medicament to induce tissue growth;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus; and

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus.

36. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member having a relaxed diameter and an outer attachment sheath;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus;

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus; and

limiting contraction of the annuloplasty ring to a contracted diameter that is larger than the relaxed diameter of the inner sizing member.

37. The method of claim 36, wherein the annuloplasty ring further includes a series of support members positioned on the inner sizing member, and wherein the step of limiting contraction is accomplished by engagement of the support members with one another.

38. The method of claim 37, wherein each support member comprises a body member having a lumen formed therein, said lumen being capable of receiving the sizing member therein.

39. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member comprising a biologically compatible elastomer and an outer attachment sheath;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus; and

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus.

40. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member and an outer attachment sheath;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device at the time of manufacture;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus; and

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus.

41. A method of implanting a self-molding annuloplasty ring in a heart valve annulus, comprising:

providing a resilient annuloplasty ring having a contracted diameter, the annuloplasty ring including a resilient inner sizing member and an outer attachment sheath;

stretching the annuloplasty ring to an expanded diameter commensurate with the diameter of a dilated heart valve annulus;

positioning the expanded annuloplasty ring on an insertion device immediately prior to implantation;

delivering the insertion device and expanded annuloplasty ring to the dilated heart valve annulus;

positioning the annuloplasty ring within the heart valve annulus;

attaching the annuloplasty ring to the dilated heart valve annulus; and

removing the insertion device so as to permit the annuloplasty ring to contract inward from its expanded diameter and decrease the size of the attached heart valve annulus.