Native valve repair devices and procedures

• US 10,238,493 B1
• Filed: 01/09/2018
• Issued: 03/26/2019
• 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): Lynch, Robert
• Application Number:
  US15/865,934
• Time in Patent Office: 441 Days
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/2902 characterized by features of the actuating rod
• CPC Class Codes: A61B 2017/2908 Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/2939 Details of linkages or pivot points
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/2484 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 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 surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device includes a pair of paddles, and at least four gripping members. The paddles are movable between an open position and a closed position, and the paddles and the at least four gripping members are configured to attach to the native valve of a patient. The gripper control mechanism is configured to independently move each of the at least four gripping members.

Claims

1. A valve repair system for repairing a native valve of a patient during a non-open heart procedure, the valve repair system comprising:

a delivery device having at least one lumen;

a valve repair device configured to be delivered through the lumen of the delivery device, and configured to attach to a native valve of a patient, the valve repair device comprising;

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

at least four gripping members, wherein the paddles and the at least four gripping members are configured to attach to the native valve of the patient;

wherein the four gripping members are disposed between the pair of paddles,

a gripper control mechanism configured to independently move each of the at least four gripping members.

2. The valve repair system according to claim 1, wherein the at least four gripping members comprise a first gripping member, a second gripping member, a third gripping member, and a fourth gripping member, wherein the first and second gripping members are configured to interact with a first paddle of the pair of paddles to attach to the native valve of the patient, and wherein the third gripping member and the fourth gripping member are configured to interact with a second paddle of the pair of paddles to attach to the native valve of the patient.

3. The valve repair system according to claim 2, wherein the gripper control mechanism comprises a first gripper control configured to move the first gripping member, a second gripper control configured to move the second gripping member, a third gripper control configured to move the third gripping member, and a fourth gripper control configured to move the fourth gripping member.

4. The valve repair system according to claim 3, wherein the first gripper control member comprises a first wire that is removably attached to the first gripping member, wherein the second gripper control member comprises a second wire removably attached to the second gripping member, wherein the third gripper control member comprises a third wire removably attached to the third gripping member, and wherein the fourth gripper control member comprises a fourth wire removably attached to the fourth gripping member.

5. The valve repair system 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.

6. The valve repair system according to claim 5, further comprising a placement shaft that is removably attached to the shaft of the base assembly of the valve repair device.

7. The valve repair system according to claim 5, wherein the valve repair device further comprises a lock movable between a locked condition and an unlocked condition, wherein the lock is configured to lock the coupler in a stationary position on the shaft when the lock is in the locked condition.

8. The valve repair system according to claim 1, wherein each of the at least four gripping members comprise a barbed portion for attaching the at least four gripping members to the native valve of a patient.

9. The valve repair system according to claim 1, further comprising a paddle control mechanism configured to move the paddles between the open position and the closed position.

10. The valve repair system according to claim 1, wherein the valve repair device further comprises 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.

11. The valve repair system according to claim 1, wherein the paddles comprise a latch member for attaching the paddles to at least one corresponding gripping member of the at least four gripping members when the paddles are in the closed position.

12. The valve repair system according to claim 1, wherein the valve repair device further comprises a biasing member for maintaining the paddles in a closed position when the valve repair device is removed from the valve repair system.

13. The valve repair system according to claim 1, wherein each of the at least four gripping members comprise a barbed portion for attaching the at least four gripping members to the native valve of a patient, and wherein the barbed portion for each of the at least four gripping members has only a single row of barbs.

14. The valve repair system according to claim 1, wherein each of the at least four gripping members are extendable in length to prevent tearing of the native valve of the patient when the first and second gripping members are removed from the native valve.

15. The valve repair device according to claim 1, wherein the gripper control mechanism comprises a plurality of catheters.

16. The valve repair device according to claim 1, wherein the gripper control mechanism comprises a plurality of wires, in which each of the plurality of wires comprises a hoop configured to engage at least one of the at least four gripping members.

17. The valve repair system according to claim 1, wherein each of the at least four gripping members comprise a flexible material such that each of the at least four gripping members can peel back from tissue of the native valve when the at least four gripping members are detached from the tissue of the native valve.

18. The valve repair system according to claim 1 wherein each of the at least four gripping members have a barbed portion.

19. The valve repair system according to claim 1 wherein each gripping member can be moved by the gripper control mechanism without moving the remaining three gripping members.

20. A valve repair system for repairing a native valve of a patient during a non-open heart procedure, the valve repair system comprising:

a delivery device having at least one lumen;

a valve repair device configured to be delivered through the lumen of the delivery device, and configured to attach to a native valve of a patient, the valve repair device comprising;

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

at least four gripping members each having a barbed portion, wherein the paddles and the at least four gripping members are configured to attach to the native valve of the patient;

wherein the four gripping members are disposed between the pair of paddles,

a gripper control mechanism configured to independently move each of the at least four gripping members, such that each gripping member can be moved by the gripper control mechanism without moving the remaining three gripping members.