Methods and systems for delivery device insertion during medical device crimp processes

Patent metadata

Field	Value
Publication number	US-12370045-B2
Application number	US-202117475519-A
Country	US
Kind code	B2
Filing date	Sep 15, 2021
Priority date	Sep 18, 2020
Publication date	Jul 29, 2025
Grant date	Jul 29, 2025

Abstract

A system for assisting in loading an implantable medical device onto a delivery system includes a body having a first end, a second end, and a conduit extending from the first end to the second end. The body has an inner diameter that allows a distal portion of the delivery system to slidably move through the conduit. The body has an outer diameter that allows the body to be inserted into a central lumen of the implantable medical device.

First claim

What is claimed is:

1. A system comprising:
a delivery system including a proximal end and a distal end, the delivery system including an inner shaft and a balloon disposed over the inner shaft and a distal portion of the inner shaft;
a prosthetic heart valve including a frame and a valve structure coupled to the frame, the prosthetic heart valve including an inflow end and an outflow end; and
a guide system including a body comprising a first end, a second end, and a conduit extending from a first opening at the first end to a second opening at the second end, wherein:
in a loading configuration, the body is disposed within the valve structure of the prosthetic heart valve and the balloon of the delivery system is disposed within the conduit of the body such that delivery system extends through the first opening and the second opening proximal and distal of the body, and
in a delivery configuration, the guide system is removed from within the valve structure and the prosthetic heart valve is in a crimped state over the balloon.

2. The system of claim 1 , wherein at least one of an outer diameter at the first end or an outer diameter at the second end is smaller than the outer diameter of the body.

3. The system of claim 1 , wherein at least one of an inner diameter at the first end or an inner diameter at the second end is smaller than the inner diameter of the body.

4. The system of claim 1 , wherein the inner diameter of the body varies along a long axis of the body.

5. The system of claim 4 , wherein the variation of the inner diameter of the body comprises one or more steps in the inner diameter of the body.

6. The system of claim 4 , wherein the variation of the inner diameter of the body comprises a continuous increase in the inner diameter of the body from the first end of the body to the second end of the body.

7. The system of claim 1 , wherein the body further comprises:
a plurality of perforations that enable the body to be divided into multiple portions such that in the delivery configuration the guide system is removed from the delivery system.

8. The system of claim 1 , wherein the delivery system further includes a distal retention member disposed within the balloon, wherein in the delivery configuration, the distal retention member is distal of the prosthetic heart valve.

9. The system of claim 8 , wherein the delivery system further includes a proximal retention member disposed within the balloon, wherein in the delivery configuration, the proximal retention member is proximal of the prosthetic valve.

10. The system of claim 9 , wherein in the delivery configuration, the inflow end of the prosthetic heart valve is disposed adjacent the distal retention member and the outflow end of the prosthetic heart valve is disposed adjacent the proximal retention member.

11. The system of claim 1 , wherein in the delivery configuration, the outflow end of the prosthetic heart valve is closer to the proximal end of the delivery system than the inflow end of the prosthetic heart valve is to the proximal end of the delivery system.

12. A method for loading a prosthetic heart valve onto a delivery system, the method comprising:
inserting a guide system into a central lumen of the prosthetic heart valve, the guide system comprising a body that defines a conduit within an interior of the body;
inserting a distal portion of the delivery system into the conduit of the guide system such that the delivery system extends proximal and distal of the guide system;
aligning a distal retention member disposed within a balloon of the distal portion of the delivery system with the prosthetic heart valve such that the distal retention member is distal of the prosthetic heart valve;
removing the guide system from the central lumen of the prosthetic heart valve; and
compressing the prosthetic heart valve onto the distal portion of the delivery device.

13. The method of claim 12 , wherein inserting the guide system comprises:
inserting the guide system into an inflow end of the prosthetic heart valve and advancing the guide system towards the outflow end of the prosthetic heart valve.

14. The method of claim 12 , wherein inserting a distal portion of the delivery system into the conduit of the guide system comprises inserting the distal portion into the conduit in a direction from the outflow end towards the inflow end of the prosthetic heart valve.

15. The method of claim 12 , wherein the delivery system includes a proximal retention member, further comprising aligning the proximal retention member such that the proximal retention member is proximal of the prosthetic heart valve.

16. A method for loading a prosthetic heart valve onto a delivery system, the method comprising:
inserting a guide system into a central lumen of the prosthetic heart valve, the guide system comprising a body that defines a conduit within an interior of the body;
inserting a distal portion of the delivery system into the conduit of the guide system;
aligning a distal retention member disposed within a balloon of the distal portion of the delivery system with the prosthetic heart valve such that the distal retention member is distal of the prosthetic heart valve;
removing the guide system from the central lumen of the prosthetic heart valve by advancing the guide system proximally through the central lumen of the prosthetic heart valve over a catheter portion of the delivery system towards a handle of the delivery system; and
compressing the prosthetic heart valve onto the distal portion of the delivery device.

17. The method of claim 16 , the method further comprising:
advancing the guide system over the prosthetic heart valve after compression of the prosthetic heart valve onto the distal portion of the delivery system to remove the guide system.

Assignees

• Medtronic Inc

Inventors

• Ung Victoria
• Mitchell James E
• Glucklich Nathanael J

Classifications

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2/2412

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

• A61F2/0095

  Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02) · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title

• A61F2/9525

  using a funnel · CPC title