Devices and methods for heart valve treatment

• US 8,070,805 B2
• Filed: 01/25/2010
• Issued: 12/06/2011
• Est. Priority Date: 01/09/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Kalgreen, Jason E., Mortier, Todd J., Schroeder, Richard, Kusz, David, Schweich, Cyril J. Jr.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/693,002
• Publication Number:
  US 20100185276A1
• Time in Patent Office: 680 Days
• Field of Search: 623 21- 237
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Claims

1. A method for treating a heart valve of a patient, comprising:

advancing a catheter having a lumen into a heart chamber, wherein a heart valve treatment device is disposed within the lumen of the catheter, the heart valve treatment device including;

an elongate member having a first end;

an anchoring mechanism secured to the first end of the elongate member; and

a plug member;

disposing the heart valve treatment device proximate the heart valve;

securing the anchoring mechanism to heart tissue; and

positioning the plug member within an orifice of the heart valve so that leaflets of the heart valve contact the plug member during a portion of the cardiac cycle.

2. The method of claim 1, wherein the plug member is expandable.

3. The method of claim 1, wherein the elongate member has a second end, and the plug member is secured to the second end.

4. The method of claim 1, wherein the step of advancing a catheter having a lumen into a heart chamber includes advancing the catheter through a blood vessel, a right atrium, and a left atrium.

5. The method of claim 4, wherein the blood vessel is a vena cava, and the heart valve is a mitral valve.

6. The method of claim 1, wherein the heart tissue is a wall of a ventricle.

7. The method of claim 1, wherein the method does not include placing the patient on cardiopulmonary bypass.

8. A method for reducing regurgitation of a mitral valve of a patient, comprising:

endovascularly advancing a catheter having a lumen to an orifice of the mitral valve, wherein a plug device is disposed within the lumen of the catheter, the plug device including an expandable mitral valve plug and an elongate member;

disposing a portion of the elongate member within a left ventricle of the heart;

securing an end of the elongate member to heart tissue; and

positioning the expandable mitral valve plug within the orifice of the mitral valve so that leaflets of the mitral valve engage the mitral valve plug during a portion of the cardiac cycle, the expandable mitral valve plug being secured to the elongate member.

9. The method of claim 8, wherein endovascularly advancing a catheter having a lumen to an orifice of the mitral valve includes advancing the catheter through a blood vessel, a right atrium, and a left atrium.

10. The method of claim 9, wherein the blood vessel is a vena cava.

11. The method of claim 8, wherein the heart tissue includes a wall of the left ventricle.

12. The method of claim 8, wherein the portion of the cardiac cycle is systole.

13. The method of claim 8, wherein method does not include placing the patient on cardiopulmonary bypass.

14. The method of claim 8, wherein the step of securing an end of the elongate member to heart tissue includes attaching the end of the elongate member to an anchor.

15. A method for reducing regurgitation of a mitral valve of a patient'"'"'s heart, comprising:

advancing a catheter including a mitral valve plug device through a patient'"'"'s vena cava, a right atrium, and into a left atrium, the mitral valve plug device including an elongate member having a first end portion and a second end portion, the second end portion including a plug secured thereto;

securing the first end portion of the elongate member to a septal wall with an anchor pad;

disposing the second end portion of the elongate member proximate the mitral valve; and

positioning the plug within an orifice of the mitral valve, such that leaflets of the mitral valve engage the plug during a portion of a cardiac cycle.

16. The method of claim 15, wherein the plug is expandable.

17. The method of claim 15, wherein the plug includes a coating.

18. The method of claim 17, wherein the coating includes an agent configured to promote endothelial growth.

19. The method of claim 16, wherein the plug is inflatable.

20. The method of claim 15, wherein the plug includes a first configuration when disposed within the catheter.

21. The method of claim 20, wherein the plug changes to a second configuration different from the first configuration when removed from the catheter.

22. The method of claim 15, wherein the plug includes an elongate configuration when positioned within the orifice of the mitral valve.

23. The method of claim 15, wherein the plug engages leaflets of the mitral valve only during the portion of the cardiac cycle.

24. The method of claim 23, wherein the portion of the cardiac cycle is systole.