Native valve repair devices and procedures

• US 10,123,873 B1
• Filed: 01/09/2018
• Issued: 11/13/2018
• Est. Priority Date: 01/09/2018
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Metchik, Asher L., Tyler, II, Gregory Scott, Winston, Matthew T., Delgado, Sergio, Freschauf, Lauren R., Dixon, Eric R., Siegel, Alexander J.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/865,929
• Time in Patent Office: 308 Days
• Field of Search: 623 21- 219
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a pair of paddles and a pair of gripping members. The paddles are moveable between an open position and a closed position. The gripping members can have different configurations for effective attachment and release from the native valve of the patient.

Claims

1. A valve repair device for repairing a native valve of a patient, the valve repair device comprising:

a pair of paddles, wherein the paddles are movable between an open position and a closed position;

a pair of gripping members, wherein each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and the gripping members are configured to attach to the native valve of the patient;

a spacer element configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

2. The valve repair device according to claim 1, further comprising a base assembly that comprises:

a shaft; and

a coupler movably attached to the shaft such that the coupler can be moved along the shaft;

wherein the pair of paddles are pivotally attached to the coupler;

wherein movement of the coupler in a first direction along the shaft causes the pair of paddles to move to the closed position, and movement of the coupler in a second direction causes the pair of paddles to move to the open position.

3. The valve repair system according to claim 1, wherein the gripping members comprise a barbed portion for attaching the gripping members to the native valve of a patient.

4. The valve repair device according to claim 1, wherein the gripping portions comprise a barbed portion for attaching the gripping members to the native valve of a patient, and wherein the barbed portion for each of the gripping members has only a single row of barbs.

5. The valve repair device according to claim 1, wherein the gripping members each comprise only a single row of barbs.

6. The valve repair device according to claim 5, further comprising a spacer element configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

7. The valve repair device of claim 1 wherein each gripping member of the pair of gripping members is extendable in length to prevent tearing of the native valve of the patient when the gripping members are removed from the native valve.

8. The valve repair device according to claim 7, further comprising a spacer element configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

9. The valve repair device according to claim 7, wherein the gripping members comprise a barbed portion for attaching the gripping members to the native valve of a patient, and wherein the barbed portion of each of the gripping members has only a single row of barbs.

10. The valve repair device according to claim 7, wherein the pair of gripping members comprises a flexible material such that the gripping members can peel back from tissue of the native valve when the gripping members are detached from the tissue of the native valve.

11. A valve repair device for repairing a native valve of a patient, the valve repair device comprising:

a pair of paddles, wherein the paddles are movable between an open position and a closed position;

a pair of gripping members, wherein each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and the gripping members are configured to attach to the native valve of the patient;

wherein the gripping members each comprise only a single row of barbs.

12. The valve repair device according to claim 11, further comprising a base assembly that comprises:

a shaft; and

a coupler movably attached to the shaft such that the coupler can be moved along the shaft;

wherein the pair of paddles are pivotally attached to the coupler;

wherein movement of the coupler in a first direction along the shaft causes the pair of paddles to move to the closed position, and movement of the coupler in a second direction causes the pair of paddles to move to the open position.

13. The valve repair device of claim 11 wherein each gripping member of the pair of gripping members is extendable in length to prevent tearing of the native valve of the patient when the gripping members are removed from the native valve.

14. The valve repair device according to claim 13, wherein the pair of gripping members comprises a flexible material such that the gripping members can peel back from tissue of the native valve when the gripping members are detached from the tissue of the native valve.

15. A valve repair device for repairing a native valve of a patient, the valve repair device comprising:

a pair of paddles, wherein the paddles are movable between an open position and a closed position;

a pair of gripping members, wherein each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and the gripping members are configured to attach to the native valve of the patient;

wherein each gripping member of the pair of gripping members is extendable in length to prevent tearing of the native valve of the patient when the gripping members are removed from the native valve.

16. The valve repair device according to claim 15, further comprising a base assembly that comprises:

a shaft; and

a coupler movably attached to the shaft such that the coupler can be moved along the shaft;

wherein the pair of paddles are pivotally attached to the coupler;

wherein movement of the coupler in a first direction along the shaft causes the pair of paddles to move to the closed position, and movement of the coupler in a second direction causes the pair of paddles to move to the open position.

17. The valve repair system according to claim 15, wherein the gripping members comprise a barbed portion for attaching the gripping members to the native valve of a patient.

18. The valve repair device according to claim 15, wherein the gripping members each comprise only a single row of barbs.

19. The valve repair device according to claim 15, further comprising a spacer element configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

20. The valve repair device according to claim 15, wherein the pair of gripping members comprises a flexible material such that the gripping members can peel back from tissue of the native valve when the gripping members are detached from the tissue of the native valve.

21. A valve repair device for repairing a native valve of a patient, the valve repair device comprising:

a pair of paddles, wherein the paddles are movable between an open position and a closed position;

a pair of gripping members each having an attachment portion and a gripping portion, wherein the attachment portion of each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the pair of paddles, and wherein the paddles and the gripping portions of the gripping members are configured to attach to the native valve of the patient.

22. The valve repair device according to claim 21, further comprising a base assembly that comprises:

a shaft; and

a coupler movably attached to the shaft such that the coupler can be moved along the shaft;

wherein the pair of paddles are pivotally attached to the coupler;

wherein movement of the coupler in a first direction along the shaft causes the pair of paddles to move to the closed position, and movement of the coupler in a second direction causes the pair of paddles to move to the open position.

23. The valve repair device according to claim 21, wherein the gripping portions each have only a single row of barbs.

24. The valve repair device according to claim 21, further comprising a spacer element configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

25. The valve repair device of claim 21 wherein each gripping member of the pair of gripping members is extendable in length to prevent tearing of the native valve of the patient when the gripping members are removed from the native valve.

26. The valve repair device according to claim 25, further comprising a spacer element configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

27. The valve repair device according to claim 25, wherein the pair of gripping members comprises a flexible material such that the gripping members can peel back from tissue of the native valve when the gripping members are detached from the tissue of the native valve.