Devices and methods for heart valve treatment

• US 7,247,134 B2
• Filed: 11/10/2003
• Issued: 07/24/2007
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Schweich, Cyril J. Jr., Ekvall, Craig, Kusz, David
• Primary Examiner(s): Gherbi; Suzette
• Application Number:
  US10/704,145
• Publication Number:
  US 20040148020A1
• Time in Patent Office: 1,352 Days
• Field of Search: 623 236- 238, 623/3.1, 623/94, 606/108, 600/16, 600/13
• US Class Current: 600/16
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands

Abstract

Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning an implantable device outside and adjacent the heart wall such that the device alters the shape of the heart wall acting on the valve. The implantable device may alter the shape of the heart wall acting on the valve by applying an inward force and/or by circumferential shortening (cinching). The shape change of the heart wall acting on the valve is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example, to reduce regurgitation.

Claims

1. A method for improving heart valve function, the method comprising:

providing a device comprising a first anchor configured to be secured to heart tissue, a second anchor configured to be secured to heart tissue, and an interconnecting member connecting the first anchor and the second anchor;

delivering the device to a heart via a transthoracic subxiphoid approach;

positioning at least a portion of the interconnecting member in contact with an external surface of a heart wall proximate a valve such that the device exerts an inward force on the heart wall sufficient to alter the valve function; and

securing the first anchor and the second anchor to an epicardial layer of the heart,

wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor.

2. The method of claim 1, wherein the inward force is sufficient to draw leaflets of the valve together.

3. The method of claim 2, wherein the valve leaflets define a line of coaptation and positioning the portion of the interconnecting member includes positioning the portion such that the inward force is exerted substantially orthogonal to the line of coaptation.

4. The method of claim 1, wherein the valve is a mitral valve.

5. The method of claim 1, wherein the inward force is exerted on an annulus of the valve.

6. The method of claim 1, wherein the inward force is sufficient to reposition papillary muscles of the valve.

7. The method of claim 1, further comprising positioning the device outside the epicardium of the heart.

8. The method of claim 1, further comprising selectively adjusting the tension of the interconnecting member.

9. The method of claim 1, further comprising adjusting a relative position of the first and second anchors so as to adjust the tension in the interconnecting member.

10. The method of claim 9, further comprising selectively locking the interconnecting member to at least one of the first anchor and the second anchor after adjusting the relative position.

11. The method of claim 10, wherein the selectively locking includes penetrating the interconnecting member with a pin.

12. The method of claim 1, wherein the securing includes securing the first anchor and the second anchor to the epicardial layer while the anchors remain free from a pericardial layer of the heart.

13. The method of claim 1, further comprising securing at least one of the first anchor and the second anchor to a pericardial layer of the heart.

14. The method of claim 1, further comprising delivering the device to the heart via a delivery catheter.

15. The method of claim 1, further comprising securing the first and second anchors to the heart tissue via tissue penetrating members.

16. The method of claim 15, further comprising remotely actuating the tissue penetrating members.

17. The method of claim 1, further comprising exerting the inward force on the heart wall throughout a cardiac cycle.

18. The method of claim 1, wherein providing the device includes providing a device comprising at least one protrusion connected to the interconnecting member and disposed between the first anchor and the second anchor.

19. The method of claim 1, wherein the securing includes securing the first and second anchors directly to the epicardial layer of the heart.

20. A method for improving heart valve function, the method comprising:

providing a device comprising a first anchor configured to be secured to heart tissue, a second anchor configured to be secured to heart tissue, and an interconnecting member connecting the first anchor and the second anchor;

delivering the device via a transthoracic subxiphoid approach;

positioning the device outside the epicardium of the heart; and

positioning at least a portion of the interconnecting member in contact with an external surface of a heart wall proximate a valve such that the device exerts an inward force on the heart wall sufficient to alter the valve function,

wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor.

21. A method for improving heart valve function, the method comprising:

providing a device comprising a first anchor configured to be secured to heart tissue, a second anchor configured to be secured to heart tissue, and an interconnecting member connecting the first anchor and the second anchor, wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor;

delivering the device via a transthoracic subxiphoid approach;

positioning at least a portion of the interconnecting member in contact with an external surface of a heart wall proximate a valve such that the device exerts an inward force on the heart wall sufficient to alter the valve function;

adjusting a relative position of the first and second anchors so as to adjust the tension in the interconnecting member; and

selectively locking the interconnecting member to at least one of the first anchor and the second anchor after adjusting the relative position,

wherein selectively locking the interconnecting member includes penetrating the interconnecting member with a pin.

22. A method for improving heart valve function, the method comprising:

providing a device comprising a first anchor configured to be secured to heart tissue, a second anchor configured to be secured to heart tissue, and an interconnecting member connecting the first anchor and the second anchor, wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor;

delivering the device via a transthoracic subxiphoid approach; and

positioning at least a portion of the interconnecting member in contact with an external surface of a heart wall proximate a valve such that the device exerts an inward force on the heart wall sufficient to alter the valve function.