Method for stabilizing a cardiac valve annulus

• US 9,421,099 B2
• Filed: 10/07/2013
• Issued: 08/23/2016
• Est. Priority Date: 04/25/2006
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Dolan, Mark
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US14/047,345
• Publication Number:
  US 20140039612A1
• Time in Patent Office: 1,051 Days
• Field of Search: 623 236- 241
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

A method for stabilizing a cardiac valve annulus is provided. The method includes intravascularly delivering a prosthesis to a region of a cardiac valve, expanding the prosthesis to secure the prosthesis to the region of the cardiac valve, and reducing the inner diameter of the prosthesis to form the region of the cardiac valve into a predefined shape.

Claims

1. A method for stabilizing a cardiac valve annulus comprising:

intravascularly delivering a prosthesis in a compressed configuration to a region of a cardiac valve, wherein the prosthesis does not include a valve and comprises a serpentine ring including a plurality of struts joined together by apexes, the prosthesis including anchoring barbs extending only from apexes at a distal end of the prosthesis, with no anchoring barbs extending from apexes at a proximal end of the prosthesis, wherein the distal end of the prosthesis is a downstream end of the prosthesis when the prosthesis is deployed in the region of the cardiac valve, wherein in the compressed configuration, the anchoring barbs extend parallel to a central axis of the prosthesis in the compressed configuration;

moving the anchoring barbs from parallel to the central axis in the compressed configuration to extending radially outward;

expanding an inner diameter of the serpentine ring to a deployment configuration to drive the anchoring barbs into the cardiac valve annulus and secure the prosthesis to the region of the cardiac valve;

after deployment, reducing the inner diameter of the serpentine ring to a resting configuration to form the region of the cardiac valve into a predefined shape.

2. The method of claim 1, wherein forming the region of the cardiac valve into the predefined shape reduces a diameter of the cardiac valve annulus.

3. The method of claim 1, wherein the serpentine ring is self-expandable.

4. The method of claim 1, wherein the serpentine ring is balloon expandable.

5. The method of claim 1, further comprising:

expanding a balloon to expand the inner diameter of the serpentine ring to the deployment configuration to secure the prosthesis to the region of the cardiac valve.

6. The method of claim 1, wherein the anchoring barbs secure the prosthesis to a posterior portion of the cardiac valve annulus.

7. The method of claim 1, wherein the prosthesis is intravascularly delivered through the femoral artery.

8. The method of claim 1, wherein the prosthesis is intravascularly delivered through the subclavian vein.

9. The method of claim 1, further comprising:

retracting a delivery sheath to expand the inner diameter of the serpentine ring.

10. A method for anchoring a prosthesis comprising:

intravascularly delivering the prosthesis to a cardiac valve annulus;

expanding an inner diameter of the prosthesis to a deployment configuration to drive prosthesis anchoring barbs into the cardiac valve annulus to secure the prosthesis to the cardiac valve annulus;

forming the cardiac valve annulus into a predefined shape by reducing the inner diameter of the prosthesis to a resting configuration,

wherein the prosthesis anchoring barbs extend only from a distal end of the prosthesis with no prosthesis anchoring barbs extending from a proximal end of the prosthesis, wherein the distal end of the prosthesis is a downstream end of the prosthesis when the prosthesis is deployed into the cardiac valve annulus, and

wherein the prosthesis anchoring barbs are only present on a posterior side of the prosthesis, wherein the posterior side of the prosthesis is aligned with a posterior side of the cardiac valve annulus in the deployment configuration.

11. The method of claim 10, wherein reducing the inner diameter of the prosthesis to the resting configuration reduces a diameter of the cardiac valve annulus.

12. The method of claim 10, wherein the prosthesis is a serpentine ring, and

wherein the prosthesis anchoring barbs extend from apexes on the distal end of the prosthesis.

13. The method of claim 10, wherein the prosthesis is self-expandable.

14. The method of claim 13, further comprising:

retracting a delivery sheath to expand the inner diameter of the prosthesis.

15. The method of claim 10, wherein the prosthesis is balloon expandable.

16. The method of claim 10, further comprising:

expanding a balloon to expand the inner diameter of the prosthesis to the deployment configuration.

17. A method for stabilizing a cardiac valve annulus comprising:

intravascularly delivering a prosthesis in a compressed configuration to a region of a cardiac valve, wherein the prosthesis comprises a self-expanding serpentine ring including a plurality of struts joined together by apexes, the prosthesis including anchoring barbs extending only from apexes at a distal end of the prosthesis, with no anchoring barbs extending from apexes at a proximal end of the prosthesis, wherein the distal end of the prosthesis is a downstream end of the prosthesis when the prosthesis is deployed in the region of the cardiac valve, wherein in the compressed configuration, the anchoring barbs extend parallel to a central axis of the prosthesis in the compressed configuration, wherein in the compressed configuration a sheath constrains the serpentine ring to a compressed diameter;

moving the anchoring barbs from parallel to the central axis in the compressed configuration to extending radially outward;

removing the sheath to allow the serpentine ring to self-expand from the compressed configuration to a resting configuration having a resting diameter larger than the compressed diameter, wherein the resting diameter is equal to a desired diameter of the cardiac valve annulus after treatment;

with the serpentine ring in the resting configuration and the anchoring barbs extending radially outward, using an expansion force to further expand an inner diameter of the serpentine ring to a deployment configuration having a deployment diameter larger than the resting diameter to drive the anchoring barbs into the cardiac valve annulus and secure the prosthesis to the region of the cardiac valve;

after using the expansion force to further expand the serpentine ring to the deployment configuration, removing the expansion force to allow the serpentine ring to return to the resting configuration to form the region of the cardiac valve into a predefined shape.