METHOD AND APPARATUS FOR REPAIRING OR REPLACING CHORDAE TENDINAE

• US 20100042147A1
• Filed: 08/14/2008
• Published: 02/18/2010
• Est. Priority Date: 08/14/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Swindle, Carl, Glines, Erin, Olson, Christopher, Janovsky, Chris, Hsu, Hsingching Crystal, Shakil, Ian, Sharma, Pooja, Rowe, Stanton
• Granted Patent: US 8,778,016 B2
• Time in Patent Office: Days
• US Class Current: 606/228
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A method and apparatus for performing mitral valve chordal repair on a patient include attaching at least one filament to a mitral valve leaflet and to a papillary muscle. A first end of a filament can be attached to the mitral valve leaflet and the length of the filament can be adjusted by adjusting the tension of the filament in a catheter. The second end of the filament can be attached to an attachment site.

Claims

1. A method of performing mitral valve chordal repair on a patient while the patient'"'"'s heart is beating, the method comprising:

making an incision in a ventricular wall of the patient at or near a papillary muscle;

inserting a catheter through the incision into a left ventricle of the patient, the catheter containing at least one filament;

attaching a first end of the filament to a mitral valve leaflet;

at least partially withdrawing the catheter from the left ventricle and navigating a distal end of the catheter to a position at or near the incision, the position being at or near an attachment site where a second end of the filament is to be attached to the papillary muscle or ventricular wall;

adjusting the length of the filament by adjusting the tension of the filament in the catheter while substantially holding the catheter at the position; and

attaching the second end of the filament to the attachment site.

2. The method of claim 1, wherein the attachment site is the papillary muscle and the attaching of the second end of the filament is achieved by using a multi-barbed anchor.

3. The method of claim 1, wherein the attachment site is the papillary muscle and the attaching of the second end of the filament is achieved by using a screw mechanism.

4. The method of claim 1, wherein the attachment site is the outside of the ventricular wall and the attaching of the second end of the filament is achieved by using a self-expanding disk.

5. A method of performing mitral valve chordal repair on a patient while the patient'"'"'s heart is beating, the method comprising:

making an incision in a ventricular wall of the patient;

inserting a catheter through the incision into a left ventricle of the patient, the catheter containing at least one filament;

attaching a first end of the filament to a mitral valve leaflet;

navigating a distal end of the catheter to a position at or near a papillary muscle, the position being at or near an attachment site where a second end of the filament is to be attached to the papillary muscle;

holding the catheter at the position;

adjusting the length of the filament by adjusting the tension of the filament in the catheter while holding the catheter at the position; and

attaching the second end of the filament to the attachment site.

6. The method of claim 5, wherein the incision is made at an apex of the heart.

7. The method of claim 5, wherein the attaching of the second end of the filament is achieved by using a multi-barbed anchor.

8. The method of claim 5, wherein the attaching of the second end of the filament is achieved by using a screw mechanism.

9. The method of claim 5, wherein the catheter is held at the position by a suction device.

10. The method of claim 5, wherein the catheter is held at the position by a clamping device.

11. A method of performing mitral valve chordal repair on a patient while the patient'"'"'s heart is beating, the method comprising:

navigating a catheter percutaneously via the patient'"'"'s vasculature into a left atrium of the patient the catheter containing at least one filament;

navigating the catheter through the left atrium and into a left ventricle of the patient;

attaching a first end of the filament to a mitral valve leaflet;

navigating a distal end of the catheter to a position at or near a papillary muscle, the position being at or near an attachment site where a second end of the filament is to be attached to the papillary muscle;

temporarily attaching the second end of the filament to the attachment site;

retracting the catheter from the left ventricle into the left atrium;

observing the effect of the filament on the beating heart;

adjusting the length of the filament in view of the act of observing the effect of the filament on the beating heart; and

permanently attaching the second end of the filament to the attachment site.

12. The method of claim 11, wherein the filament is temporarily attached to the attachment site by using a clip.

13. The method of claim 11, wherein the filament is temporarily attached to the attachment site by a temporary suturing technique.

14. The method of claim 11, wherein the length of the filament is adjusted by adjusting the tension of the filament in the catheter.

15. The method of claim 11, wherein the act of temporarily attaching the second end of the filament to the attachment site and the act of permanently attaching the second end of the filament to the attachment site are achieved by the different attachment mechanisms.

16. A method of performing mitral valve chordal repair on a patient while the patient'"'"'s heart is beating, the method comprising:

navigating a catheter percutaneously via the patient'"'"'s vasculature into the left atrium of the patient, the catheter containing at least one filament;

inserting the catheter into the left ventricle of the patient through the mitral valve;

attaching a first end of the filament to a first mitral valve leaflet;

passing a second end of the filament through a first papillary muscle of the patient at an attachment site;

withdrawing the catheter and the second end of the filament from the left ventricle into the left atrium;

adjusting the length of the filament by adjusting the tension of the filament in the catheter; and

attaching the filament to the attachment site.

17. The method of claim 16, wherein the act of attaching the filament to the attachment site comprises:

advancing a clip along the filament to the attachment site; and

securing the clip to the filament at the attachment site.

18. The method of claim 16, further comprising:

passing the second end of the filament through a second papillary muscle at a second attachment site prior to withdrawing the catheter and the second end of the filament from the left ventricle.

19. The method of claim 18, further comprising:

attaching the second end of the filament to a second mitral valve leaflet after adjusting the length of the filament.

20. A method of improving the function of native mitral valve leaflets, the method comprising:

inserting the catheter into the left ventricle of the patient, the catheter containing at least one triangular shaped member, the triangular shaped member having a short side and at least one point opposite the short side;

attaching the short side of the triangular shaped member to the valve annulus of the mitral valve; and

attaching the at least one point opposite the short side of the triangular shaped member to a papillary muscle of the patient.

21. The method of claim 20, further comprising shortening the effective length of the triangular shaped member by applying tension to a length adjustment member that extends along at least a portion of the triangular shaped member.

22. The method of claim 20, further comprising shortening the effective length of the triangular shaped member by sewing up slack in the triangular shaped member at the ring annulus.

23. The method of claim 20, wherein the triangular shaped member comprises two points opposite the short side, with each of the two points being attached to the papillary muscle of the patient.

24. The method of claim 20, wherein the triangular shaped member further comprises at least a portion of a ring attached to the short side of the triangular shaped member, and the method further comprises attaching the at least a portion of the ring to the valve annulus.

25. A triangular shaped member for attachment to a valve annulus of a mitral valve and a papillary muscle of a patient the triangular shaped member comprising:

a short side and at least one point opposite the short side; and

a length adjustment member extending along at least a portion of the triangular shaped member;

wherein the short side of the triangular shaped member is configured for attachment to the valve annulus and the at least one point opposite the short side of the triangular shaped member is configured for attachment to the papillary muscle of the patient, and

wherein the length adjustment member is configured to adjust the effective length of the triangular shaped member when tension is applied to the length adjustment member.

26. The triangular shaped member of claim 25, further comprising at least a portion of a ring attached to the short side of the triangular shaped member.

27. A method of performing mitral valve chordal repair on a patient while the patient'"'"'s heart is beating, the method comprising:

navigating a distal end of a catheter to a mitral valve leaflet of the patient, the catheter containing at least one filament, the filament having a first end and a second end;

passing the first end of the filament through a first attachment point at the mitral valve leaflet;

navigating the distal end of the catheter to a position at or near a papillary muscle, the position being at or near a second attachment point on the papillary muscle;

passing the first end of the filament through the second attachment point;

adjusting the length of the filament by adjusting tension of the filament in the catheter;

passing the first end of the filament through a securing device; and

securing the first end of the filament to another portion of the filament using the securing device.

28. The method of claim 27, wherein the step of adjusting the length of the filament further comprises passing the first end of the filament into the catheter to facilitate manual adjustment of tension of the filament in the catheter.

29. The method of claim 27, wherein the first attachment point comprises an anchor with an eyelet.

30. The method of claim 27, wherein the second attachment point comprises a moveable stitch.

31. The method of claim 27, wherein the securing device comprises a zip-tie device.

32. A method of performing mitral valve chordal repair on a patient while the patient'"'"'s heart is beating, the method comprising:

attaching a first anchor device to a papillary muscle of the patient, the first anchor device comprising an eyelet for receiving a filament;

attaching a second anchor device to a mitral valve leaflet of the patient, the second anchor device comprising an eyelet for receiving a filament;

forming a filament loop by passing a first end of the filament through the eyelet of the first anchor device and the eyelet of the second anchor device; and

fixing the length of the filament between the first and second anchor devices using a securing device.

33. The method of claim 32, farther comprising:

passing the first end of the filament back into the catheter after forming the filament loop; and

adjusting the length of the filament between the first and second anchor devices by adjusting the tension of the filament in the catheter.

34. The method of claim 32, wherein the securing device comprises a clip secured to the filament at the first anchor device.

35. The method of claim 32, wherein the securing device comprises a weld, the weld securing the filament to itself at a point along the filament loop.