Transcatheter prosthesis with sealing component, and systems and methods for delivering and deployment thereof

Patent metadata

Field	Value
Publication number	US-11666435-B2
Application number	US-202016906121-A
Country	US
Kind code	B2
Filing date	Jun 19, 2020
Priority date	Aug 24, 2017
Publication date	Jun 6, 2023
Grant date	Jun 6, 2023

Abstract

A transcatheter prosthesis with radially compressed and expanded configurations. An elongate member encircling at least a portion of the prosthesis, and configured to provide a seal between the prosthesis and a native anatomy when the prosthesis is deployed in the radially expanded configuration. The elongate member may be a resilient elongate member having a radially contracted state, when in tension, to hold at least the portion of the prosthesis in the radially compressed configuration, and having a radially expanded state, when relaxed, to provide the seal between at least the portion of the prosthesis and a native anatomy when the prosthesis is deployed. A system for delivering the transcatheter prosthesis may include a delivery catheter having an elongate cinching member encircling at least a second portion of the prosthesis, wherein the elongate cinching member is configured to hold the second portion of the prosthesis in the radially compressed configuration.

First claim

What is claimed is:

1. A transcatheter prosthesis having a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within a native anatomy comprising:
a frame; and
a sealing component coupled to an outer surface of the frame, the sealing component including an elongate member, wherein a cross-section of the elongate member has an expanded outer diameter when the elongate member is in a radially expanded state and a contracted outer diameter when the elongate member is in a radially contracted state, the contracted outer diameter of the cross-section of the elongate member being less than the expanded outer diameter of the cross-section of the elongate member, and
wherein the elongate member is configured to axially elongate under tension to transition the elongate member from the radially expanded state to the radially contracted state, and
wherein the elongate member in the radially expanded state provides a seal between the prosthesis and the native anatomy when the prosthesis is in the radially expanded configuration.

2. The transcatheter prosthesis of claim 1 , wherein the sealing component further comprises a fixation member that extends outwardly from the outer surface of the frame, wherein the elongate member is slidably disposed within the fixation member.

3. The transcatheter prosthesis of claim 2 , wherein the cross-section of the elongate member in its expanded outer diameter in the radially expanded state fills the fixation member to extend the fixation member outwardly, whereby the elongate member and the fixation member provide the seal between the prosthesis and the native anatomy when the prosthesis is in the radially expanded configuration.

4. The transcatheter prosthesis of claim 2 , wherein the fixation member is attached to the frame to encircle at least a portion of the outer surface of the frame.

5. The transcatheter prosthesis of claim 2 , wherein the fixation member is formed by a fold in an outer layer of material of the prosthesis that is configured to extend outwardly from the frame to form a channel, and the elongate member is slidably disposed within the channel.

6. The transcatheter prosthesis of claim 2 , wherein the fixation member comprises a plurality of fixation members, and the elongate member is disposed within the plurality of fixation members.

7. The transcatheter prosthesis of claim 2 , wherein the fixation member comprises a plurality of fixation members and the elongate member comprises a plurality of elongate members with each elongate member disposed within a corresponding fixation member of the plurality of fixation members.

8. The transcatheter prosthesis of claim 1 , wherein the elongate member has a generally helical path about the outer surface of the frame.

9. The transcatheter prosthesis of claim 1 , wherein the elongate member has a generally circular path about the outer surface of the frame.

10. The transcatheter prosthesis of claim 1 , wherein the elongate member is a loose spinning of individual fibers.

11. The transcatheter prosthesis of claim 1 , wherein the elongate member is a spiral wrapping of one or more fibers around a central core.

12. The transcatheter prosthesis of claim 1 , wherein the elongate member is a tubular structure of woven or braided mesh.

13. The transcatheter prosthesis of claim 1 , wherein the prosthesis is a valve prosthesis, and the frame of the prosthesis includes a prosthetic valve component disposed within and secured to the frame.

14. A method of deploying and sealing a prosthesis within a native anatomy comprising:
loading a prosthesis with a sealing component onto a delivery catheter, the sealing component being coupled to an outer surface of a frame of the prosthesis and including an elongate member, wherein a cross-section of the elongate member has a contracted outer diameter when the elongate member is in tension in a radially contracted state and an expanded outer diameter when the elongate member is relaxed in a radially expanded state, the contracted outer diameter of the cross-section of the elongate member being less than the expanded outer diameter of the cross-section of the elongate member, wherein the elongate member is configured to axially elongate under tension to transition the elongate member from the radially expanded state to the radially contracted state;
positioning the prosthesis in a radially compressed configuration at the native anatomy, wherein the elongate member is in the radially contracted state during positioning of the prosthesis;
deploying the prosthesis to a radially expanded configuration within the native anatomy; and
releasing the elongate member to permit the elongate member to return to the radially expanded state, wherein the elongate member in the radially expanded state provides a seal between the prosthesis and the native anatomy when the prosthesis is in the radially expanded configuration.

15. The method of claim 14 , wherein the elongate member includes a plurality of elongate members and the step of releasing the elongate member includes releasing the plurality of elongate members.

16. The method of claim 14 , wherein the prosthesis is a valve prosthesis and the native anatomy is a native heart valve.

17. The method of claim 14 , wherein the delivery catheter comprises at least one cinching member to hold the prosthesis in the radially compressed configuration, and wherein deploying the prosthesis includes releasing and removing the at least one cinching member.

18. The method of claim 14 , wherein the delivery catheter comprises an outer sheath to hold the prosthesis in the radially compressed configuration, and wherein deploying the prosthesis includes retracting the outer sheath.

19. The method of claim 14 , wherein the elongate member in the radially contracted state holds at least a portion of the prosthesis in the radially compressed configuration, and wherein deploying the prosthesis includes releasing the elongate member.

20. The method of claim 14 , wherein the sealing component also includes a fixation member that extends outwardly from the outer surface of the frame, wherein the elongate member is slidably disposed within the fixation member.

Assignees

• Medtronic Vascular Inc

Inventors

• Griffin Patrick
• Keogh James R

Classifications

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2250/0069

  Sealing means · CPC title

• A61F2002/9511

  the retaining means being filaments or wires · CPC title

• A61F2250/0014

  having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title