Native valve repair devices and procedures

• US 10,130,475 B1
• Filed: 01/09/2018
• Issued: 11/20/2018
• 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): Dang, Son
• Application Number:
  US15/865,944
• Time in Patent Office: 315 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0056 W-shaped, e.g. M-shaped, sigma-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 surgical delivery instrument, a valve repair device, and a paddle 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 attach to a native valve of a patient. The valve repair device includes a first paddle, a second paddle, and a pair of gripping members. The first and second paddles are movable between an open position and a closed position. The paddles and the gripping members are configured to attach to the native valve of the patient. The paddle control mechanism is configured to move the first and second paddles independently of each other.

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;

a first paddle and a second paddle, wherein the first and second paddles are movable between an open position and a closed position; and

a pair of gripping members, wherein the paddles and the gripping members are configured to attach to the native valve of the patient;

a paddle control mechanism for moving the first and second paddles, wherein the paddle control mechanism is configured to move the first and second paddles independently of each other;

a base that comprises;

a first shaft;

a second shaft;

a first coupler movable along the first shaft; and

a second coupler movable along the second shaft;

wherein the first paddle is pivotally attached to the first coupler, and second paddle is pivotally attached to the second coupler;

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

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

2. The valve repair system according to claim 1, wherein the valve repair device further comprises a first lock and a second lock, wherein the first and second locks are movable between a locked condition and an unlocked condition, wherein the first lock is configured to lock the first coupler in a stationary position on the first shaft when the first lock is in the locked condition, and wherein the second lock is configured to lock the second coupler in a stationary position on the second shaft when the second lock is in the locked condition.

3. The valve repair system according to claim 1, wherein the valve repair device is configured to move to a bailout position for removal of the valve repair device from the patient'"'"'s body, wherein, when the valve repair device is in the bailout position, an angle between each paddle and a shaft of the base assembly is greater than or equal to 120 degrees.

4. The valve repair system according to claim 1, wherein the first and second paddles of the valve repair device are configured to flex upon being attached to the native valve of the patient.

5. The valve repair system according to claim 1, further comprising a gripper control mechanism configured to move the gripping members.

6. 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.

7. The valve repair system according to claim 1, wherein each gripping member of the pair of gripping members is directly attached to a corresponding paddle of the first and second paddles.

8. The valve repair system according to 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.

9. The valve repair system according to claim 1, 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.

10. The valve repair system according to claim 1, wherein the gripping members are connected to each other by a biasing member that is configured to maintain the gripping members in a desired position.

11. 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 first paddle and a second paddle, wherein the first and second paddles are movable between an open position and a closed position; and

a pair of gripping members, wherein the paddles and the gripping members are configured to attach to the native valve of the patient;

a paddle control mechanism for moving the first and second paddles, wherein the paddle control mechanism is configured to move the first and second paddles independently of each other; and

a base assembly that comprises;

a first shaft having a first threaded portion, and a second shaft having a second threaded portion; and

a first coupler movably attached to the first shaft such that the first coupler can be moved along the first threaded portion of the shaft;

a second coupler movably attached to the second shaft such that the second coupler can be moved along the second threaded portion of the shaft;

wherein the first paddle is pivotally attached to the first coupler;

wherein the second paddle is pivotally attached to the second coupler;

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

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