Thermally-Activated Biocompatible Foam Occlusion Device for Self-Expanding Heart Valves

• US 20140277428A1
• Filed: 01/29/2014
• Published: 09/18/2014
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Skemp, Benedict, Parsonage, Edward E., Eidenschink, Tracee, Kurane, Aditee
• Granted Patent: US 10,314,698 B2
• Time in Patent Office: Days
• US Class Current: 623/2.42
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A structure for sealing a gap between a medical device and adjacent body tissue includes a ring-shaped body formed at least in part of a material that expands from a compressed condition to an expanded condition when heated to a transition temperature and that is adapted to conform to the body tissue in the expanded condition.

Claims

1. A structure for sealing a gap between a medical device and adjacent body tissue, the structure comprising:

a ring-shaped body formed at least in part of a material that expands from a compressed condition to an expanded condition when heated to a transition temperature and that is adapted to conform to the body tissue in the expanded condition.

2. The structure of claim 1, wherein the transition temperature is a crystalline melting point of the material.

3. The structure of claim 1, wherein the transition temperature is a temperature at which the material undergoes a glass transition.

4. The structure of claim 1, wherein the transition temperature is a denaturation temperature of the material.

5. The structure of claim 1, wherein the material is a shape-memory material.

6. The structure of claim 5, wherein the shape-memory material comprises a hydrogel polymer.

7. The structure of claim 5, wherein the shape-memory material comprises a porous polymer foam.

8. The structure of claim 5, wherein the shape-memory material comprises a naturally-derived polymer.

9. The structure of claim 1, wherein the medical device is a prosthetic heart valve having a collapsible and expandable stent, a valve assembly disposed in the stent for controlling the flow of blood through the stent, and a cuff disposed about the valve assembly, and wherein the ring-shaped body overlaps with a portion of the cuff.

10. The structure of claim 1, wherein, in a use condition, the material in only a localized portion of the ring-shaped body is placed in the expanded condition.

11. The structure of claim 1, wherein, in a use condition, the entire ring-shaped body is substantially uniformly placed in the expanded condition.

12. A prosthetic heart valve, comprising:

a collapsible and expandable stent;

a valve assembly disposed in the stent for controlling the flow of blood through the stent; and

a cuff disposed about the valve assembly, the cuff including a material that expands from a compressed condition to an expanded condition when heated to a transition temperature.

13. The prosthetic heart valve of claim 12, wherein the material comprises a hydrogel.

14. The prosthetic heart valve of claim 14, wherein the material comprises a biocompatible foam.

15. A method of sealing a space between a medical device and adjacent tissue, the method comprising:

delivering the medical device and a ring-shaped body to a target site using a delivery system;

delivering thermal energy to the ring-shaped body to heat at least a portion of the ring-shaped body to at least a transition temperature;

expanding the ring-shaped body from a compressed condition to an expanded condition; and

sealing the space between the medical device and the adjacent tissue with the expanded ring-shaped body disposed therebetween.

16. The method of claim 15, wherein the thermal energy is supplied by an ablation catheter having at least one ablation electrode.

17. The method of claim 16, wherein the at least one ablation electrode is configured to deliver high-frequency alternative current to the ring-shaped body.

18. The method of claim 15, wherein the thermal energy is supplied by a plurality of ablation catheters.

19. The method of claim 15, wherein the thermal energy is supplied by a guidewire having at least one localization feature and at least one electrode for delivering the thermal energy.

20. The method of claim 19, wherein the at least one localization feature includes a radiopaque electrode.

21. The method of claim 15, wherein the thermal energy is supplied by forceps configured to grasp the medical device and transmit heat to the ring-shaped body.

22. The method of claim 15, wherein the thermal energy is supplied by a balloon catheter comprising a balloon fillable with a warm medium.