Native valve repair devices and procedures

Patent metadata

Field	Value
Publication number	US-12090052-B2
Application number	US-202017078208-A
Country	US
Kind code	B2
Filing date	Oct 23, 2020
Priority date	Jan 9, 2018
Publication date	Sep 17, 2024
Grant date	Sep 17, 2024

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.

First claim

The invention claimed is:

1. A valve repair system for repairing a native valve of a patient, the valve repair system comprising:
a catheter; and
a valve repair device coupled to the catheter, 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 that are configured to attach to the native valve of the patient;
at least one spacer element that is disposed between the pair of gripping members, wherein the spacer element is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve; and
wherein, seen in a plan view from an atrial side of the native valve, the spacer element extends past one or more side edges of the gripping members when the paddles and the gripping members are closed.

2. 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; and
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 the patient.

4. 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 pair of paddles.

5. The valve repair system according to claim 1 , wherein each paddle includes a main portion and first and second side portions that are integrally formed with the main portion and extend from the main portion and are configured to contour to a shape of the native valve, wherein the pair of paddles are configured such that the first and second side portions flex away from the main portion upon being attached to the native valve of the patient.

6. A valve repair system for repairing a native valve of a patient, the valve repair system comprising:
a catheter; and
a valve repair device coupled to the catheter, 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 that are configured to attach to the native valve of the patient;
at least one spacer element that is disposed between the pair of gripping members, wherein the spacer element is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve;
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.

7. The valve repair system according to claim 6 , wherein the gripping members comprise a barbed portion for attaching the gripping members to the native valve of the patient, and wherein the barbed portion for each of the gripping members has only a single row of barbs.

8. The valve repair system according to claim 6 , 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.

9. A method for repairing a native valve of a patient, the method comprising:
attaching a shaft to a coupler such that the coupler can be moved along the shaft;
pivotally attaching the pair of paddles to the coupler;
moving a pair of paddles between an open position and a closed position, wherein the pair of paddles are moved to the closed position when the coupler is moved in a first direction along the shaft, and wherein the pair of paddles are moved to the open position when the coupler is moved in a second direction along the shaft; and
attaching the paddles and a pair of gripping members to the native valve of the patient; and
flexing and peeling back the gripping members away from tissue of the native valve.

10. The method according to claim 9 , further comprising moving a lock between a locked condition and an unlocked condition, and locking the coupler in a stationary position on the shaft when the lock is in the locked condition.

11. The method according to claim 9 , further comprising attaching the gripping members to the native valve of the patient with a barbed portion of the gripping members.

12. A valve repair system for repairing a native valve of a patient, the valve repair system comprising:
a catheter; and
a valve repair device coupled to the catheter, 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 that are configured to attach to the native valve of the patient;
at least one spacer element that is disposed between the pair of gripping members, wherein the spacer element is configured to fill at least a portion of a gap in the native valve of the patient when the valve repair device is attached to the native valve;
wherein the gripping members each comprise only a single row of barbs.

13. The valve repair system according to claim 12 , wherein the gripping members comprise a barbed portion for attaching the gripping members to the native valve of the patient, and wherein the barbed portion for each of the gripping members has only the single row of barbs.

Assignees

• Edwards Lifesciences Corp

Inventors

• Metchik Asher L
• Tyler Ii Gregory Scott
• Winston Matthew T
• Delgado Sergio
• Freschauf Lauren R
• Dixon Eric Robert
• Siegel Alexander J

Classifications

• A61F2/2463

  Implants forming part of the valve leaflets · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2220/0025

  Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements · CPC title

• A61F2230/0013

  Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title