Method for stabilizing a cardiac valve annulus

• US 9,999,505 B2
• Filed: 07/18/2016
• Issued: 06/19/2018
• 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
• Application Number:
  US15/212,323
• Publication Number:
  US 20160324638A1
• Time in Patent Office: 701 Days
• 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 reshaping a mitral valve annulus comprising:

advancing the distal tip of a delivery catheter comprising a delivery sheath containing a prosthesis through a pulmonary vein, through a left atrium to the mitral valve annulus, the prosthesis including a ring and a plurality of anchor members extending from one end of the ring, the delivery sheath containing the ring in a compressed configuration during the advancing step;

retracting the delivery sheath from the prosthesis, wherein when the delivery sheath is retracted, the ring self-expands from the compressed configuration to a pre-deployment configuration;

expanding an inner diameter of the ring to a deployment configuration to drive the anchor members into the mitral valve annulus to secure the prosthesis to the mitral valve annulus; and

reducing the inner diameter of the ring to a resting configuration to reshape the mitral valve annulus, wherein the ring is formed of a shape memory material, wherein the step of reducing the inner diameter of the ring to the resting configuration is achieved by the ring self-contracting to the resting configuration due to the shape-memory material,

wherein the ring in the pre-deployment configuration has a smaller diameter than the ring in the deployment configuration and a larger diameter than the ring in the compressed configuration.

2. The method of claim 1, further comprising using fluoroscopic guidance or echocardiographic guidance for the step of advancing the distal tip of the catheter to the mitral valve annulus.

3. The method of claim 1, wherein when the delivery sheath is retracted the anchor members assume a radially extended insertion configuration.

4. The method of claim 1, wherein the step of expanding the inner diameter of the ring to the deployment configuration to drive the anchor members into the mitral valve annulus comprises inflating a balloon to expand the ring.

5. The method of claim 1, wherein the ring is a serpentine ring.

6. The method of claim 1, wherein the anchor members comprise barbs.

7. The method of claim 1, wherein the anchor members are disposed on only a posterior portion of the ring, and wherein the step of expanding the inner diameter of the ring to the deployment configuration comprises expanding the inner diameter of the ring to the deployment configuration to drive the anchor members into only a posterior portion of the mitral valve annulus.

8. A method for reshaping a mitral valve annulus comprising:

advancing the distal tip of a delivery catheter comprising a delivery sheath containing a prosthesis in a compressed configuration through a pulmonary vein, through a left atrium to the mitral valve annulus, wherein the prosthesis is a closed ring;

retracting the delivery sheath from the prosthesis, wherein the prosthesis comprises a plurality of anchor members extending from one end of the prosthesis, wherein when the delivery sheath is retracted the anchor members assume a radially extended insertion configuration;

expanding an inner diameter of the prosthesis to a deployment configuration to drive the anchor members in the radially extended insertion configuration into the mitral valve annulus to secure the prosthesis to the mitral valve annulus; and

reducing the inner diameter of the prosthesis to a resting configuration to reshape the mitral valve annulus.

9. The method of claim 8, further comprising using fluoroscopic guidance or echocardiographic guidance for the step of advancing the distal tip of the catheter to the mitral valve annulus.

10. The method of claim 8, wherein when the delivery sheath is retracted, the prosthesis self-expands from the compressed configuration to a pre-deployment configuration having a smaller diameter than the prosthesis in the deployment configuration.

11. The method of claim 8, wherein the prosthesis is balloon expandable.

12. The method of claim 8, wherein the step of expanding the inner diameter of the prosthesis to the deployment configuration to drive the anchor members into the mitral valve annulus comprises inflating a balloon to expand the prosthesis.

13. The method of claim 8, wherein the prosthesis is a serpentine ring.

14. The method of claim 8, wherein the anchor members comprise barbs.

15. The method of claim 8, wherein the anchor members are disposed on only a posterior portion of the prosthesis, and wherein the step of expanding the inner diameter of the prosthesis to the deployment configuration comprises expanding the inner diameter of the prosthesis to the deployment configuration to drive the anchor members into only a posterior portion of the mitral valve annulus.