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

• US 10,722,351 B2
• Filed: 08/24/2017
• Issued: 07/28/2020
• Est. Priority Date: 08/24/2017
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Griffin, Patrick, Keogh, James R.
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US15/685,212
• Publication Number:
  US 20190060062A1
• Time in Patent Office: 1,069 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2250/0014 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 Class Codes: A61F 2250/0069 Sealing means

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.

Claims

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;

a fixation member extending outwardly from an outer surface of the frame; and

a resilient elongate member slidably disposed within the fixation member, the resilient elongate member having a cross-section with a contracted outer diameter in a radially contracted state when in tension and an expanded outer diameter in a radially expanded state when relaxed, 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 resilient elongate member in the radially contracted state is configured to hold the prosthesis in the radially compressed configuration, and

wherein at least the resilient 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 cross-section of the resilient elongate member in its expanded outer diameter in the radially expanded state fills the fixation member to extend the fixation member outwardly, whereby the resilient 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.

3. The transcatheter prosthesis of claim 1, wherein the fixation member is attached to the frame to encircle at least a portion of the outer surface of the frame.

4. The transcatheter prosthesis of claim 3, wherein a fold in the outer layer of material is configured to extend outwardly from the frame to form a channel, and the resilient elongate member is slidably disposed within the channel.

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

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

7. The transcatheter prosthesis of claim 1, wherein the fixation member comprises a plurality of fixation members spaced apart about a circumference of the frame, and the resilient elongate member is disposed within the plurality of fixation members.

8. The transcatheter prosthesis of claim 1, wherein the fixation member comprises a plurality of fixation members and the resilient elongate member comprises a plurality of resilient elongate members with each resilient elongate member disposed within a corresponding fixation member of the plurality of fixation members.

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

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

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

12. 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.

13. A method of deploying and sealing a prosthesis within a native anatomy comprising:

loading a prosthesis with a fixation member and a resilient elongate member onto a delivery catheter, wherein the resilient elongate member is slidably disposed within the fixation member, has a cross-section with a contracted outer diameter in a radially contracted state when in tension and the cross-section has an expanded outer diameter in a radially expanded state when relaxed, 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 the resilient elongate member is configured to hold the prosthesis in a radially compressed configuration when in the radially contracted state;

positioning the prosthesis in the radially compressed configuration at the native anatomy; and

releasing the resilient elongate member to permit the prosthesis to return to a radially expanded configuration and to permit the resilient elongate member to return to the radially expanded state such that at least the resilient elongate member seals between the prosthesis and the native anatomy to prevent blood flow therebetween.

14. The method of claim 13, wherein the resilient elongate member includes a plurality of resilient elongate members and the step of releasing the resilient elongate member includes releasing the plurality of resilient elongate members.

15. The method of claim 13, wherein the delivery catheter comprises an elongate cinching member configured to aid in holding the prosthesis in the radially compressed configuration, and wherein the method further includes

releasing and removing the elongate cinching member of the delivery catheter in conjunction with releasing the resilient elongate member, to permit the prosthesis to return to the radially expanded configuration.

16. The method of claim 15, wherein the delivery catheter includes a plurality of elongate cinching members, and the step of releasing and removing the elongate cinching member of the delivery catheter includes releasing and removing the plurality of elongate cinching members of the delivery catheter.

17. The method of claim 13, wherein the resilient elongate member is configured to hold a first portion of the prosthesis in the radially compressed configuration and the delivery catheter includes an elongate cinching member configured to hold a second portion of the prosthesis in the radially compressed configuration, and

wherein the step of releasing the resilient elongate member permits the first portion of the prosthesis to return to the radially expanded configuration, and

wherein the method further includes releasing and removing the elongate cinching member of the delivery catheter to permit the second portion of the prosthesis to return to the radially expanded configuration.

18. The method of claim 17, wherein the delivery catheter further includes a second elongate cinching member configured to hold a third portion of the prosthesis in the radially compressed configuration.

19. The method of claim 18, wherein the method further includes releasing and removing the second elongate cinching member of the delivery catheter to permit the third portion of the prosthesis to return to the radially expanded configuration.

20. The method of claim 13, wherein the prosthesis is a valve prosthesis and the native anatomy is a native heart valve.