Native valve repair devices and procedures

• US 10,076,415 B1
• Filed: 01/09/2018
• Issued: 09/18/2018
• 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): Miles, Jonathan
• Application Number:
  US15/865,904
• Time in Patent Office: 252 Days
• 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 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
• CPC Class Codes: A61F 2230/0045 Omega-shaped

Abstract

A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

Claims

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

a base assembly comprising a plurality of pivoting links and a shaft, wherein the pivoting links are moved by the shaft;

a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position;

a pair of gripping members attached to the base assembly, wherein the paddles and the gripping members are configured to attach to valve leaflets of the patient;

at least one spacer element that surrounds the shaft and is disposed between the pair of gripping members;

wherein the spacer element is made from at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue;

wherein the spacer element fills a space between the gripping members when the paddles are in the closed position.

2. The valve repair device according to claim 1, wherein the base assembly of the valve repair device further comprises:

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 device according to claim 1, wherein the spacer element includes a first spacer member attached to a first gripping member of the pair of gripping members and a second spacer member attached to a second gripping member of the pair of gripping members.

4. The valve repair device according to claim 1, wherein the spacer element extends past one or more side edges of the gripping members.

5. The valve repair device according to claim 1, wherein the spacer element comprises a main portion extending between the gripping members and extending portions that extend past the side edges of the gripping members.

6. The valve repair device according to claim 5, wherein the extending portions have a semicircular shape.

7. The valve repair device of claim 1, wherein the spacer element is configured to fill at least a portion of a gap between mitral valve leaflets of the patient.

8. 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;

a base assembly comprising a plurality of pivoting links and a shaft, wherein the pivoting links are moved by the shaft;

a pair of paddles attached to the base assembly, wherein the movement of the pivoting links moves the paddles between an open position and a closed position;

a pair of gripping members attached to the base assembly, wherein the paddles and the gripping members are configured to attach to valve leaflets of the patient;

at least one spacer element that surrounds the shaft and is disposed between the pair of gripping members;

wherein the spacer element is made from at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue;

wherein the spacer element fills a space between the gripping members when the paddles are in the closed position.

9. The valve repair system according to claim 8, wherein the base assembly of the valve repair device further comprises:

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.

10. The valve repair system according to claim 9, wherein the spacer element includes a first spacer member attached to a first gripping member of the pair of gripping members and a second spacer member attached to a second gripping member of the pair of gripping members.

11. The valve repair system according to claim 8, wherein the spacer element extends past one or more side edges of the gripping members.

12. The valve repair system according to claim 8, wherein the spacer element comprises a main portion extending between the gripping members and extending portions that extend past the side edges of the gripping members.

13. The valve repair system according to claim 12, wherein the extending portions have a semicircular shape.

14. The valve repair device of claim 8, wherein the spacer element is configured to fill at least a portion of a gap between mitral valve leaflets of the patient.