Coiled implant for mitral valve repair

• US 7,637,946 B2
• Filed: 02/01/2007
• Issued: 12/29/2009
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Kalam, Faisal, Zhang, Xiangyang, Solem, Jan Otto, Popp, Michael
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/670,386
• Publication Number:
  US 20070185572A1
• Time in Patent Office: 1,062 Days
• Field of Search: 623 236- 238
• US Class Current: 623/2.37
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

An apparatus for treating a mitral valve, comprising an elongate member having a spiral shape, the elongate member having a proximal end portion and a distal end portion, an expandable proximal anchor joined to the proximal end portion of the elongate body, and an expandable distal anchor joined to the distal end portion of the elongate body. The elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus.

Claims

1. An apparatus for treating a mitral valve, comprising:

an elongate member formed with a substantially spiral shape, the elongate member having a proximal end portion and a distal end portion;

an expandable proximal anchor joined to the proximal end portion of the elongate member; and

an expandable distal anchor joined to the distal end portion of the elongate member;

wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus;

wherein the elongate member comprises a plurality of coils and wherein one or more coils includes at least one window through which a resorbable material is threadable.

2. The apparatus of claim 1, wherein the plurality of coils have one or more spaces therebetween, and wherein a resorbable material is disposed within the spaces between adjacent coils for maintaining the elongate member in the elongated state.

3. An apparatus for treating a mitral valve, comprising:

an elongate member formed with a substantially spiral shape, the elongate member having a proximal end portion and a distal end portion;

an expandable proximal anchor joined to the proximal end portion of the elongate member; and

an expandable distal anchor joined to the distal end portion of the elongate member;

wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus;

wherein the elongate member comprises two substantially parallel spiral members.

4. The apparatus of claim 3, wherein the two substantially parallel spiral members have one or more spaces therebetween, and wherein a resorbable material is disposed within the spaces between for maintaining the elongate member in the elongated state.

5. An apparatus for treating a mitral valve, comprising:

an elongate member formed with a substantially spiral shape, the elongate member having a proximal end portion and a distal end portion;

an expandable proximal anchor joined to the proximal end portion of the elongate member; and

an expandable distal anchor joined to the distal end portion of the elongate member;

wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus;

wherein the elongate member has an undulating configuration, and wherein a resorbable material is disposed within spaces in the undulating configuration for maintaining the elongate member in the elongated state;

wherein the elongate member has a substantially C-shaped cross section.

6. An apparatus for treating a mitral valve, comprising:

an elongate member formed with a substantially spiral shape, the elongate member having a proximal end portion and a distal end portion;

an expandable proximal anchor joined to the proximal end portion of the elongate member; and

an expandable distal anchor joined to the distal end portion of the elongate member;

wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus;

wherein the proximal anchor and the distal anchor have a spiral shape.

7. An apparatus for treating a mitral valve, comprising:

an elongate member having a spiral shape, the elongate member having a proximal end portion and a distal end portion, wherein the elongate member comprises a plurality of coils;

an expandable proximal anchor joined to the proximal end portion of the elongate body; and

an expandable distal anchor joined to the distal end portion of the elongate body;

wherein the expandable proximal anchor and the expandable distal anchor are joined to the elongate body by sutures.

8. The apparatus of claim 7, wherein the elongate member comprises a memory material.

9. The apparatus of claim 7, wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral annulus.

10. A method for treating a mitral valve using an implant, the implant including an elongate member having a spiral shape with coils, the elongate member having a proximal end portion and a distal end portion, an expandable proximal anchor joined to the proximal end portion of the elongate member, and an expandable distal anchor joined to the distal end portion of the elongate member, the method comprising:

inserting the implant at least partially into the coronary sinus;

expanding and anchoring the expandable distal anchor in the coronary sinus;

expanding and anchoring the expandable proximal anchor in or outside of the coronary sinus; and

after expanding and anchoring the expandable proximal and distal anchors, allowing resorption of resorbable material extending through openings in the coils, thereby causing the elongate member to change in length.

11. The method of claim 10, wherein the implant has resorbable material disposed within spaces between the coils to maintain the elongate member in an expanded state, and the method further comprises:

after expanding and anchoring the expandable distal anchor, and after expanding and anchoring the expandable proximal anchor, allowing the resorbable material to be resorbed, causing the elongate member to shorten and thereby reshape a mitral annulus.

12. The method of claim 10, further comprising:

after expanding and anchoring the expandable distal anchor, but before expanding and anchoring the expandable proximal anchor, retracting the expandable proximal anchor proximally with respect to the expandable distal anchor.

13. An apparatus for treating a patient, comprising:

an elongate member formed with a substantially spiral shape, the elongate member having a proximal end portion and a distal end portion;

an expandable proximal anchor joined to the proximal end portion of the elongate member; and

an expandable distal anchor joined to the distal end portion of the elongate member;

wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into the patient;

wherein the elongate member comprises a plurality of coils and at least one opening in the plurality of coils through which a resorbable material is threadable.

14. The apparatus of claim 13, wherein the plurality of coils have one or more spaces therebetween, and wherein a resorbable material is disposed within the spaces between adjacent coils for maintaining the elongate member in the elongated state.

15. The apparatus of claim 14, further comprising a sheath covering the elongate member, the sheath maintaining the resorbable material in the spaces of the elongate member.

16. The apparatus of claim 13, wherein the apparatus is formed from a single piece of material.

17. The apparatus of claim 13, wherein the elongate member is made from shape memory material.

18. The apparatus of claim 17, wherein the shape memory material is nitinol.

19. The apparatus of claim 13, wherein the apparatus is sized to be inserted at least partially into the coronary sinus.

20. An apparatus for treating a patient, comprising:

an elongate member formed with a substantially spiral shape, the elongate member having a proximal end portion and a distal end portion;

an expandable proximal anchor joined to the proximal end portion of the elongate member and having a substantially spiral shape; and

an expandable distal anchor joined to the distal end portion of the elongate member and having a substantially spiral shape;

wherein the elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into the patient.

21. The apparatus of claim 20, wherein the elongate member comprises a plurality of coils and wherein one or more coils.

22. The apparatus of claim 20, wherein the plurality of coils has one or more spaces therebetween, and wherein a resorbable material is disposed within the spaces between adjacent coils for maintaining the elongate member in the elongated state.