Granted Patent B2

US 12,605,248 · App. 18/359,833 · Granted Apr 21, 2026

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

Assignee: Edwards Lifesciences Corporation

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

Abstract

Claims (44)

1 . A system comprising:

a delivery apparatus;

a leaflet clip device coupled to the delivery apparatus, the leaflet clip device comprising:

a clipping member comprising an intermediate portion, a first leg portion and a second leg portion;

a first tensioning member attached to the first leg portion;

wherein the first tensioning member is configured to apply tension to the first leg to move the first leg portion;

a second tensioning member attached to the second leg portion;

wherein the second tensioning member is configured to apply tension to the second leg portion to move the second leg portion;

wherein the clipping member can be transformed from a delivery configuration to an implantation configuration;

wherein when the clipping member is in the implantation configuration, first sections of each of the leg portions extend toward each other from respective ends of the intermediate portion of the clipping member to define a clipping region for capturing a pair of leaflets and second sections of each of the leg portions then extend away from each other moving in a direction away from the clipping region;

wherein the first tensioning member and the second tensioning member are configured to move the first leg portion and the second leg portion of the clipping member to capture one or more native valve leaflets in the implantation configuration;

wherein the delivery apparatus includes a strain gauge; and

wherein the strain gauge is configured to measure a force that can be withstood by the leaflet clip device without disengaging from the one or more native valve leaflets when the clipping member is in the implantation configuration.

2 . The system of claim 1 wherein the clipping member is in a substantially longitudinally extended configuration in the delivery configuration and the first portion and the second portion are drawn toward one another as the clipping member is transformed from the delivery configuration to the implantation configuration.

3 . The system of claim 1 wherein the first portion and the second portion are configured to engage a pair of the one or more native valve leaflets at a center of the native valve along coaptation edges of the pair of the one or more native valve leaflets.

4 . The system of claim 1 wherein the clipping member is shape set in the implantation configuration and a resiliency of shape memory material of the clipping member provides sufficient force against a pair of the one or more native valve leaflets to anchor the clipping member onto the pair of the one or more native valve leaflets.

5 . The system of claim 1 wherein the strain gauge is configured to determine a force applied by the first and second tensioning members.

6 . The system of claim 5 wherein the first tensioning member comprises a first cord and the second tensioning member comprises a second cord.

7 . The system of claim 1 wherein the first tensioning member comprises a first cord and the second tensioning member comprises a second cord.

8 . A system comprising:

a delivery apparatus;

a leaflet clip device coupled to the delivery apparatus, the leaflet clip device comprising:

a clipping member comprising an intermediate portion, a first leg portion and a second leg portion;

wherein the clipping member can be transformed from a delivery configuration to an implantation configuration;

wherein when the clipping member is in the implantation configuration, first sections of each of the leg portions extend toward each other from respective ends of the intermediate portion of the clipping member to define a clipping region for capturing a pair of leaflets and second sections of each of the leg portions then extend away from each other moving in a direction away from the clipping region;

wherein the delivery apparatus includes a strain gauge; and

wherein the strain gauge is configured to measure a force that can be withstood by the leaflet clip device without disengaging from one or more native valve leaflets when the clipping member is in the implantation configuration.

9 . The system of claim 8 wherein the clipping member is in a substantially longitudinally extended configuration in the delivery configuration and the first portion and the second portion are drawn toward one another as the clipping member is transformed from the delivery configuration to the implantation configuration.

10 . The system of claim 8 wherein the first portion and the second portion are configured to engage a pair of the one or more native valve leaflets at a center of the native valve along coaptation edges of the pair of the one or more native valve leaflets.

11 . The system of claim 8 wherein the clipping member is shape set in the implantation configuration and a resiliency of shape memory material of the clipping member provides sufficient force against a pair of the one or more native valve leaflets to anchor the clipping member onto the pair of the one or more native valve leaflets.

12 . The system of claim 8 wherein a first tensioning member comprises a first cord and a second tensioning member comprises a second cord.

13 . A system comprising:

a delivery apparatus;

a leaflet clip device coupled to the delivery apparatus, the leaflet clip device comprising:

a clipping member comprising an intermediate portion, a first leg portion and a second leg portion;

wherein the clipping member can be transformed from a delivery configuration to an implantation configuration;

wherein when the clipping member is in the implantation configuration, first sections of each of the leg portions extend toward each other from respective ends of the intermediate portion of the clipping member to define a clipping region for capturing a pair of leaflets and second sections of each of the leg portions then extend away from each other moving in a direction away from the clipping region;

wherein the delivery apparatus includes a strain gauge; and

wherein the strain gauge is configured to measure a force applied to the leaflet clip device when the clipping member is in the implantation configuration.

14 . The system of claim 13 wherein the clipping member is in a substantially longitudinally extended configuration in the delivery configuration and the first portion and the second portion are drawn toward one another as the clipping member is transformed from the delivery configuration to the implantation configuration.

15 . The system of claim 13 wherein the first portion and the second portion are configured to engage a pair of one or more native valve leaflets at a center of the native valve along coaptation edges of the pair of one or more native valve leaflets.

16 . The system of claim 13 wherein the clipping member is shape set in the implantation configuration and a resiliency of shape memory material of the clipping member provides sufficient force against a pair of one or more native valve leaflets to anchor the clipping member onto the pair of one or more native valve leaflets.

17 . The system of claim 13 wherein the strain gauge is configured to determine a force applied by first and second tensioning members.

18 . The system of claim 13 wherein a first tensioning member comprises a first cord and a second tensioning member comprises a second cord.

Assignments (1)

Continuity (4)

References Cited (400)