Native valve repair devices and procedures

• US 10,595,997 B2
• Filed: 09/25/2018
• Issued: 03/24/2020
• 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 Robert, Siegel, Alexander J.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US16/141,549
• Publication Number:
  US 20190209295A1
• Time in Patent Office: 546 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 movable between an open position and a closed position. Each of the gripping members has a barbed portion for securing the gripping members to the native valve of a patient. Each gripping member is slidably attached to a corresponding paddle. Each gripping member can be moved in a first direction along the paddle before the barbed portion of the gripping member pierces the native valve of the patient. Each gripping member can be moved in a direction substantially opposite the first direction after the barbed portion pierces the native valve of the patient such that the gripping members create a tensioning force on 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 that are movable between an open position and a closed position; and

a pair of gripping members that each have a barbed portion for securing the gripping member to the native valve of the patient;

wherein each gripping member of the pair of gripping members is slidably attached to a corresponding paddle of the pair of paddles;

wherein each gripping member is moved in a first direction along the paddle before the barbed portion of the gripping member pierces the native valve of the patient; and

wherein each gripping member is moved in a direction along the paddle substantially opposite the first direction after the barbed portion pierces the native valve of the patient such that the gripping members create a tensioning force on the native valve of the patient.

2. The valve repair device according to claim 1, further comprising at least one biasing member configured to bias the gripping members in the direction substantially opposite the first direction.

3. The valve repair device according to claim 1, wherein barbed portion of each gripping member comprises barbs disposed at a proximal end of the gripping member.

4. The valve repair device according to claim 1, wherein the barbed portion comprises a single row of barbs disposed at a proximal end of the gripping member.

8. The valve repair device according to claim 1, wherein each gripping member of the pair of gripping members includes a flexing portion that is more flexible than another portion of the gripping member.

9. The valve repair device according to claim 1, further comprising a gripper control mechanism usable to control movement of a gripping member of the pair of gripping members.

5. A method for repairing a native valve of a patient, the method comprising:

moving a gripping member from a first position to a second position along a paddle;

positioning the paddle such that valve tissue of a native valve of a patient is disposed between the gripping member and the paddle;

closing the gripping member such that a barbed portion of the gripping member pierces the valve tissue; and

moving the gripping member back along the paddle from the second position to the first position after the barbed portion of the at least one gripping member pierces the valve tissue.

6. The method according to claim 5, further comprising moving the pair of paddles from an open position to a closed position to secure the valve repair device to the valve tissue of the native valve of the patient.

7. The method according to according to claim 5, wherein the valve repair device further comprises a biasing member configured to bias the gripping member toward the first position.

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

a pair of paddles that are movable between an open position and a closed position; and

a pair of gripping members that each have a barbed portion for securing the gripping member to the native valve of the patient;

wherein each gripping member of the pair of gripping members is movably attached to a corresponding paddle of the pair of paddles;

wherein each gripping member is configured to move in a first direction relative to the paddle before the barbed portion of the gripping member pierces tissue of the native valve of the patient; and

wherein each gripping member is configured to move in a different second direction relative to the paddle after the barbed portion pierces the tissue of the native valve of the patient such that the gripping members impart a tensioning force on the tissue of the native valve of the patient.

11. The valve repair device according to claim 10, further comprising at least one biasing member configured to bias the gripping members in the second direction.

12. The valve repair device according to claim 10, wherein the barbed portion comprises a single row of barbs disposed at an end of the gripping member.

13. The valve repair device according to claim 10, wherein each gripping member of the pair of gripping members includes a flexing portion that is more flexible than an adjacent portion of the gripping member.

14. The valve repair device according to claim 13, wherein the flexing portion includes at least one of a cutout or different material.

15. The valve repair device according to claim 10, further comprising a gripper control mechanism usable to control movement of the pair of gripping members.

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

a first paddle and a second paddle that are each movable between an open position and a closed position; and

a first gripping member having a first barbed portion and a second gripping member having a second barbed portion;

wherein the first gripping member is movably attached to the first paddle and the second gripping member is movably attached to the second paddle;

wherein the first gripping member is configured to move in a first direction relative to the paddle before the first barbed portion of the first gripping member pierces tissue of the native valve of the patient and move in a different second direction relative to the paddle after the barbed portion pierces the tissue of the native valve of the patient such that the first gripping member imparts a tensioning force on the tissue of the native valve of the patient.

17. The valve repair device according to claim 16, further comprising at least one biasing member configured to bias the first gripping member in the second direction.

18. The valve repair device according to claim 17, wherein the biasing member is configured to slide the first gripping member in the second direction along the paddle to impart the tensioning force on the tissue.

19. The valve repair device according to claim 16, wherein the first gripping member includes a flexing portion that is more flexible than an adjacent portion of the first gripping member.

20. The valve repair device according to claim 16, further comprising a gripper control mechanism usable to control movement of the first gripping member.