ARTIFICIAL CHORDAE REPLACEMENT

• US 20030105519A1
• Filed: 09/04/1998
• Published: 06/05/2003
• Est. Priority Date: 09/04/1997
• Status: Abandoned Application

• Current Assignee: Endocore Incorporated
• Original Assignee: Endocore Incorporated
• Inventors: SLEPIAN, MARVIN J., FASOL, ROLAND
• Application Number:
  US09/148,819
• Publication Number:
  US 20030105519A1
• Time in Patent Office: Days
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

Artificial chordae having a strand member and a first and second pair of sutures at either longitudinal end of the strand member. The artificial chordae is preferably a unitary unit, formed from inelastic flexible material. In one embodiment, the artificial chordae comprises multiple strand members joined together at a joined end. Different sized artificial chordae are provided sized to fit the patient'"'"'s heart. The appropriately sized artificial chordae is chosen by using a chordae sizing gauge having a shaft and a transverse member, to measure the space within the patient'"'"'s heart where the artificial chordae is attached. The artificial chordae

Claims

1. Artificial chordae for a heart valve, comprising:

a) at least one strand member having a first end and a second end, and being configured to extend from a papillary muscle to a location on the heart valve; and

b) a first pair of sutures extending from the first end of the strand member and a second pair of sutures extending from the second end of the strand member.

2. The artificial chordae of claim 1 wherein the location on the heart valve is a valve leaflet edge.

3. The artificial chordae of claim 1 wherein the strand member is from about 75 cm to about 90 cm in length.

4. The artificial chordae of claim 1 wherein the sutures are from about 1 cm to about 6 cm in length.

5. The artificial chordae of claim 1 wherein the strand member and the sutures are formed from one unitary piece of material.

6. The artificial chordae of claim 1 wherein the strand member and the sutures are formed from expanded polytetrafluoroethylene.

7. The artificial chordae of claim 6 wherein the expanded polytetrafluoroethylene is selected from the group consisting of polytetrafluoroethylene suture material and polytetrafluoroethylene fabric.

8. The artificial chordae of claim 1 having at least two strand members, with the first ends of the strand members fixed together to form a joined end, wherein the strand members are longitudinally juxtaposed, and having one pair of sutures extending from the joined end, and a pair of sutures extending from the second end of each strand member.

9. The artificial chordae of claim 8 wherein the strand members are of equal lengths.

10. The artificial chordae of claim 1 wherein at least one pair of sutures includes a pledget at an interface between the sutures and the stand member.

11. The artificial chordae of claim 1 wherein at least one pair of sutures includes a stopping member configured to secure to the sutures.

12. The artificial chordae of claim 11 wherein the stopping member comprises a clip configured to grippingly secure to the pair of sutures.

13. The artificial chordae of claim 1 wherein the stopping member comprises a tube having a bore configured to slidably receive one or more of the sutures of the pair of sutures, and having a fastening member to secure the suture to the tube.

14. The artificial chordae of claim 1 wherein the strand member has a length that is adjustable.

19. The sizing gauge of claim 10 wherein the distance between the transverse member and the second end of the shaft is substantially equal to the distance between the papillary muscle and a valve leaflet edge of the heart valve.

20. The sizing gauge of claim 10 wherein the transverse member is mounted so as to slide along the shaft, and further including a means for releasably locking the transverse member onto the rod.

21. The sizing gauge of claim 10 having a handle on the first end of the shaft.

15. The artificial chordae of claim 15 wherein the strand member is formed of a material that is heat shrinkable or chemically shrinkable.

16. The artificial chordae of claim 15 wherein the strand member is foldable and including a connecting member for connecting one or more folds of the strand member together.

17. The artificial chordae of claim 16 wherein the connecting member is selected from the group consisting of pins, sutures, and clamps, rings.

18. A heart valve chordae sizing gauge for measuring the distance between a papillary muscle and a location on a heart valve, comprising a shaft having a first end and a second end, and a transverse member spaced a distance between the first and second ends of the shaft.

22. A method of attaching an artificial chordae in a heart, comprising:

a) providing an artificial chordae, comprising;

at least one strand member having a first end and a second end, and configured to extend from a papillary muscle to a location on the heart valve; and

a first pair of sutures extending from the first end of the strand member and a second pair of sutures extending from the second end of the strand member; and

b) attaching the sutures to the papillary muscle and to the heart valve, to attach the artificial chordae in the heart.

23. The method of claim 22 wherein the step of attaching the sutures further comprises:

a) stitching the first pair of sutures through a valve leaflet edge and tying the two sutures into a knot so that the first end of the strand member is secured to the valve leaflet edge; and

b) stitching the second pair of sutures through the papillary muscle and tying the two sutures into a knot so that the second end of the strand member is secured to the papillary muscle.

24. The method of claim 23 wherein the artificial chordae is attached by first attaching the first pair of sutures to a valve annulus of a heart valve prosthesis before the heart valve prosthesis is implanted, and then attaching the second pair of sutures to the papillary muscle after the heart valve prosthesis is implanted.

25. The method of claim 22 including, before step a, the step of measuring the distance between the papillary muscle and the location on the heart valve with a heart valve chordae sizing gauge, the gauge comprising a shaft having a first end and a second end, and a transverse member spaced a distance between the first and second ends of the shaft.

26. The method of claim 25 wherein the measuring step comprises holding the sizing gauge between the papillary muscle and a valve leaflet edge so that the second end of the sizing gauge contacts the papillary muscle and sliding the transverse member along the shaft until the member contacts the valve leaflet edge.

27. The method of claim 22 wherein at least one pair of sutures includes a stopping member configured to secure to the sutures, and wherein the step of attaching the sutures to the papillary muscle includes the step of stitching the pair of sutures through the papillary muscle from a first side to a second side of the papillary muscle, and securing the stopping member to the suture at a location on the suture adjacent the second side of the papillary muscle, to thereby prevent the displacement of the suture from the second side to the first side of the papillary muscle.

28. The method of claim 22 wherein at least one pair of sutures includes a stopping member configured to secure to the sutures, and wherein the step of attaching the sutures to the heart valve includes the step of stitching the pair of sutures through a valve leaflet edge from a first side to a second side of the valve leaflet edge, and securing the stopping member to the suture at a location on the suture adjacent the second side of the valve leaflet edge, to thereby prevent the displacement of the suture from the second side to the first side of the valve leaflet edge.

29. The method of claim 22 wherein the strand member has a length that is adjustable, and including the step of adjusting the length of the strand member to conform to a length between the papillary muscle and a location of the heart valve.

30. The method of claim 29 wherein the step of adjusting the length of the strand member includes the step of folding a length of the strand member, and connecting the folds together to decrease the length of the strand member.

31. The method of claim 29 wherein the step of adjusting the length of the strand member includes heat shrinking or chemically shrinking the strand member to decrease the length of the strand member.

32. An artificial chordae for a heart valve of a patient'"'"'s heart, comprising:

a) a suture having a first end and a second end; and

b) a first stopping member on the first end, and a second stopping member on the second end, each securing member being configured to secure to the suture, to thereby secure the suture within the patient'"'"'s heart.

33. The artificial chordae of claim 32 wherein the stopping member comprises a clip configured to grippingly secure to the suture.

34. The artificial chordae of claim 32 wherein the stopping member comprises a tube having a bore configured to slidably receive the suture, and having a fastening member to secure the suture to the tube.

35. A method of attaching an artificial chordae in a patient'"'"'s heart, comprising:

a) providing an artificial chordae comprising

a suture having a first end and a second end; and

a first stopping member on the first end and a second stopping member on the second end, each stopping member being configured to secure to the suture for securing the suture within the patient'"'"'s heart;

b) attaching the first end of the suture to a papillary muscle of the patient'"'"'s heart by stitching the first end of the suture through the papillary muscle from a first side of the muscle to a second side of the muscle, and positioning the stopping member at a location on the suture adjacent the second side of the papillary muscle, and securing the stopping member to the suture to thereby prevent the displacement of the suture from the second side to the first side of the papillary muscle; and

d) attaching the second end of the suture to a valve leaflet edge of the patient'"'"'s heart by stitching the second end of the suture through the valve leaflet edge at a location on the valve leaflet edge from a first side of the valve leaflet edge to a second side of the valve leaflet edge so that a length of suture conforms to a length between the papillary muscle and the location on the valve leaflet edge, and positioning the stopping member at a location on the suture adjacent the second side of the valve leaflet edge, and securing the stopping member to the suture to thereby prevent the displacement of the suture from the second side to the first side of the valve leaflet edge.