Granted Patent B2

US 12,251,309 · App. 17/227,201 · Granted Mar 18, 2025

Inventors: Lauren R. Freschauf (Mission Viejo, CA); Ralph Schneider (Trabuco Canyon, CA)

Assignee: EDWARDS LIFESCIENCES CORPORATION

A61F2/246A61B17/083A61B17/122A61B17/1227A61B2017/00243A61B2017/00862A61B2017/00867A61F2210/0014A61F2230/0045

Abstract

Claims (32)

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

a delivery apparatus having at least one delivery lumen;

a leaflet clip device coupleable to the delivery apparatus and configured to be implanted on the native valve of the patient to reduce regurgitation through the native valve, the leaflet clip device comprising:

a clipping member comprising a body having two leg portions, wherein the clipping member can be transformed between a first configuration in which the leg portions are spaced apart from each other and a second configuration in which the leg portions contact each other, wherein the clipping member is configured to attach to one or more leaflets of the native valve when in the second configuration;

wherein the clipping member is shape set in the second configuration such that the clipping member automatically reverts back to the second configuration when released from the first configuration;

wherein the at least one delivery lumen of the delivery apparatus is sized to receive the leaflet clip device and retain the clipping member of the leaflet clip device for delivery through the patient's body;

wherein the delivery apparatus comprises a first shaft and a second shaft that extend through the at least one delivery lumen;

a tensioning mechanism configured to transform the clipping member between a delivery configuration and the second configuration;

wherein the first shaft is coupled to the leaflet clip device such that a user can move the first shaft to move the leaflet clip device within the at least one delivery lumen of the delivery apparatus; and

wherein the second shaft is coupled to the tensioning mechanism of the leaflet clip device such that a user can rotate the second shaft to move the clipping member between the delivery configuration and the second configuration.

2. The valve repair system according to claim 1 , wherein rotation of at least a portion of the tensioning mechanism causes tensioning of one or more cords of the tensioning mechanism.

3. The valve repair system according to claim 1 , further comprising one or more cords extending to the two leg portions, wherein the one or more cords are operatively connected to the tensioning mechanism to transform the clipping member between the delivery configuration and the second configuration, wherein the one or more cords comprise a first cord and a second cord, wherein the first cord has a proximal end portion that is operatively connected to the tensioning mechanism and a distal end portion that is connected to a first leg portion of the two leg portions of the clipping member, and wherein the second cord has a proximal end portion that is operatively connected to the tensioning mechanism and a distal end portion that is connected to a second leg portion of the two leg portions of the clipping member.

4. A method of reducing regurgitation through a native heart valve, comprising:

delivering a leaflet clip device to the native heart valve with a delivery apparatus, wherein the leaflet clip device comprises a clipping member, a first tensioning member, and a second tensioning member, the first tensioning member fixed to a distal end portion of a first end portion of a first leg portion of the clipping member and the second tensioning member fixed to a distal end portion of a second end portion of a second leg portion of the clipping member;

extending the leaflet clip device outside a delivery lumen of the delivery apparatus such that the clipping member automatically reverts from a delivery configuration to an implantation configuration;

positioning the leaflet clip device adjacent the native heart valve; and

applying tension to the first and second tensioning members of the leaflet clip device to capture the native valve with the clipping member, wherein coaptation edges of adjacent leaflets of the native valve are captured between the first and second leg portions of the clipping member such that the coaptation edges contact one another.

5. The method according to claim 4 , wherein the clipping member has a substantially linear shape in the delivery configuration.

6. The method according to claim 5 , wherein the extending of the leaflet clip device outside the delivery lumen of the delivery apparatus comprises moving a first shaft distally relative to the delivery apparatus, and wherein the applying tension to the first and second tensioning members of the leaflet clip device comprises rotating a second shaft.

7. A valve repair system for repairing a native valve of a patient, the valve repair system comprising:

a delivery apparatus having at least one delivery lumen;

a leaflet clip device coupleable to the delivery apparatus and configured to be implanted on the native valve of the patient to reduce regurgitation through the native valve, the leaflet clip device comprising:

a clipping member comprising a body having two leg portions, wherein the clipping member can be transformed between a first configuration in which the leg portions are spaced apart from each other and a second configuration in which the leg portions contact each other, wherein the clipping member is configured to attach to one or more leaflets of the native valve when in the second configuration;

wherein the clipping member is shape set in the second configuration such that the clipping member automatically reverts back to the second configuration when released from the first configuration; and

wherein the leaflet clip device further comprises a retaining mechanism disposed within a lumen of the clipping member, wherein the retaining mechanism retains the shape of the clipping member in the second configuration.

8. The valve repair system according to claim 7 , wherein the retaining mechanism comprises a first locking member and a second locking member for retaining the shape of the clipping member in the second configuration, and wherein transformation of the clipping member to the second configuration allows movement of the first locking member and the second locking member relative to each other.

9. A valve repair system for repairing a native valve of a patient, the valve repair system comprising:

a delivery apparatus having at least one delivery lumen;

a leaflet clip device coupleable to the delivery apparatus and configured to be implanted on the native valve of the patient to reduce regurgitation through the native valve, the leaflet clip device comprising:

a clipping member comprising a body having two leg portions, wherein the clipping member can be transformed between a first configuration in which the leg portions are spaced apart from each other and a second configuration in which the leg portions contact each other, wherein the clipping member is configured to attach to one or more leaflets of the native valve when in the second configuration;

wherein the clipping member is shape set in the second configuration such that the clipping member automatically reverts back to the second configuration when released from the first configuration; and

wherein the second configuration of the clipping member comprises a primary clipping region defined between the two leg portions of the clipping member, and wherein the primary clipping region is configured to capture a pair of leaflets such that adjacent surfaces of the leaflets contact one another.

Assignments (1)

Continuity (3)

References Cited (400)

Cited By (2)

US 12,702,797 US 12,740,863