System and method for crimping and loading a prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-12533233-B2
Application number	US-202519077896-A
Country	US
Kind code	B2
Filing date	Mar 12, 2025
Priority date	Oct 27, 2021
Publication date	Jan 27, 2026
Grant date	Jan 27, 2026

Abstract

A loading assembly, can include a support tube configured to be disposed over a shaft of a delivery apparatus, a funnel member disposed over a first end portion of the support tube and configured to be disposed over at least a portion of a medical device, a first clamp member disposed over a portion of the funnel member, and a second clamp member disposed over a second end portion of the support tube. The funnel member can be axially advanced over a medical device, or the medical device can be retracted inside the funnel member to radially compresses the medical device.

First claim

We claim:

1 . A system for loading a delivery apparatus, the system comprising:
a housing sized to receive a radially expanded prosthetic heart valve, the housing comprising a funnel segment extending at least partially along an axial length of the housing, an outlet in communication with the funnel segment, an actuator configured to help move the prosthetic heart valve at least partially through the funnel segment and at least partially out of the outlet; and a loading assembly, comprising:
a support tube disposable over a capsule of a delivery apparatus,
a funnel member disposable over a portion of the support tube and disposable over at least a portion of the prosthetic valve,
wherein the loading assembly is configured such that axial advancement of the funnel member over the prosthetic valve or retraction of the prosthetic valve through the funnel member radially compresses the prosthetic valve by engagement with the funnel member.

2 . The system of claim 1 , wherein the housing comprises an extender portion having a first threaded surface, and wherein the actuator comprises a second threaded surface configured to engage the first threaded surface of the extender portion.

3 . The system of claim 1 , further comprising a pusher member coupled to the actuator, wherein the actuator is configured to cause axial advancement of the pusher member such that the pusher member advances the prosthetic heart valve at least partially through the funnel segment and at least partially out of the outlet.

4 . The system of claim 1 , further comprising a first clamp member disposable over a portion of the funnel member, and a second clamp member disposable over a second end portion of the support tube.

5 . The system of claim 4 , wherein the support tube comprises first and second portions and wherein the first and second portions are retained together by the first clamp member and the second clamp member.

6 . The system of claim 4 , wherein the first and second clamp members each comprise a first and second ribs extending from an inner surface, the first and second ribs defining a channel between them.

7 . The system of claim 6 , wherein a portion of the support tube comprises a third rib extending axially along at least a portion of a length of the support tube, and wherein when the loading assembly is assembled, the third rib is configured to be disposed within the channel of the second clamp member.

8 . The system of claim 7 , wherein the funnel member comprises a fourth rib extending axially along an outer surface of the funnel member, and wherein when the loading assembly is assembled, the fourth rib is configured to be disposed within the channel of the funnel member.

9 . The system of claim 1 , wherein the first and second clamp members each comprise a main body, wherein the first clamp member comprises one or more first tab members extending laterally away from the main body, and wherein the first tab members have a sinusoidal shape, and wherein the second clamp member comprises one or more second tab members extending laterally away from the main body, and wherein the second tab member have a length greater than a length of the first tab members.

10 . The system of claim 1 , wherein the loading assembly further comprises a ring configured to retain a portion of the capsule of the delivery apparatus between an inner surface of the ring and an outer surface of the support tube.

11 . A system usable for coupling a medical device and a delivery apparatus, wherein the medical device is radially expandable and compressible, the system comprising:
a crimping device, comprising
a housing having an inlet sized to receive the medical device in a radially expanded state, the housing comprising a funnel segment extending at least partially along an axial length of the housing, and an outlet in communication with the funnel segment, and
an actuator configured to engage a pusher member such that rotation of the actuator axially advances the pusher member to move the medical device along the funnel segment of the housing to at least partially crimp the medical device and to advance at least a portion of the medical device out of the outlet, such that the medical device can be coupled to the delivery apparatus;
a support tube having first and second portions positionable around a capsule of the delivery apparatus, the support tube comprising a proximal end portion and a distal end portion; and a funnel member releasably couplable to the distal end portion of the support tube and configured to radially compress and guide the medical device into the capsule as the funnel member is advanced over the medical device or as the medical device is retracted through the funnel member.

12 . The system of claim 11 , wherein the crimping device is configured such that after the medical device is moved along the funnel segment of the housing to at least partially crimp the medical device and to advance at least a portion of the medical device out of the outlet, and the medical device is coupled to the delivery apparatus, the crimping device can be removed from around the medical device before the funnel member is separately used to radially compress and guide the medical device into the capsule.

13 . The system of claim 11 , further comprising a first clamp member and a second clamp member, wherein the first clamp member includes a first alignment feature configured to engage a corresponding alignment feature on a proximal end portion of the support tube, and wherein the first clamp member further includes two opposed first tabs extending from an outer surface of the first clamp member, the first tabs each comprising a laterally extending portion.

14 . The system of claim 13 , wherein the second clamp member includes a second alignment feature configured to engage a corresponding alignment feature of the funnel member, the second clamp member further including two opposed second tab members, each comprising a sinusoidal shape.

15 . The system of claim 14 , wherein the funnel member further comprises first and second flanges extending from an outer surface of the funnel member, wherein the second clamp member comprises a stopping surface configured to engage the first and second flanges of the funnel member to prevent the second clamp member from advancing past a selected location.

16 . A system usable for loading a medical device into a capsule of a delivery apparatus, comprising:
a loading assembly, comprising:
a support tube configured to be disposed over the capsule of the delivery apparatus;
a funnel member disposable over a portion of the support tube and disposable over at least a portion of the medical device;
wherein the loading assembly is configured such that axial advancement of the funnel member over the medical device or retraction of the medical device through the funnel member radially compresses the medical device as the medical device is moved into the capsule.

17 . The system of claim 16 , further comprising a first clamp member disposable over a portion of the funnel member, and a second clamp member disposable over a second end portion of the support tube.

18 . The system of claim 16 , wherein an outer surface of a first end portion of the support tube comprises one or more recesses extending inwardly toward a central axis of the support tube, and wherein the funnel member comprises an annular shoulder disposed within the one or more recesses when the loading assembly is in an assembled configuration.

19 . T

Assignees

• Edwards Lifesciences Corp

Inventors

• Srinimukesh Harish Manickam
• Stewart Kevin M
• Becerra Matthew Michael
• White Richard D
• Landon David Robert
• Yeh Jonathan
• Luong Hieu Minh
• Malaeb Deena Jamal
• Parikh Parth Himanshu
• Aguayo Christopher

Classifications

• A61F2/243 Primary

  Deployment by mechanical expansion · CPC title

• A61F2/9524

  Iris-type crimpers · CPC title

• A61F2/9525

  using a funnel · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title