Inflatable Annular Sealing Device for Prosthetic Mitral Valve

• US 20140296975A1
• Filed: 01/14/2014
• Published: 10/02/2014
• Est. Priority Date: 04/02/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: TEGELS, Zachary J., EKVALL, Craig A., VIDLUND, Robert M.
• Granted Patent: US 9,486,306 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

This invention relates to a pre-configured compressible transcatheter prosthetic cardiovascular valve having an improved anterior leaflet sealing component comprising an inflatable annular sealing device made of a shell of elastomeric material, stabilized tissue or synthetic material, attached to the stent, and wherein during deployment of the valve the shell is filled to form a subvalvular seal. The invention also relates to methods for deploying such a valve for treatment of a patient in need thereof.

Claims

1. A pre-configured compressible transcatheter prosthetic cardiovascular valve having an improved anterior leaflet sealing component, which comprises an expandable leaflet assembly comprised of stabilized tissue or synthetic material, said leaflet assembly disposed within an expandable stent having at a distal end a plurality of articulating collar support structures having a tissue covering to form an atrial collar, said expandable stent having a proximal end comprised of an integral tether connection apparatus, said anterior leaflet sealing component comprising an inflatable annular sealing device made of a shell of elastomeric material, stabilized tissue or synthetic material, said an inflatable annular sealing device attached to the stent, wherein during deployment of the valve the shell is filled to form a subvalvular seal.

2. The prosthetic heart valve of claim 1, further comprising wherein the shell is comprised of an elastomer silicone, stabilized tissue, or synthetic material, and may be filled with surgical cement, a two-part epoxy, silicone gel or other biocompatible gel, saline, or a coiled material, spring-like material, or elastic material.

3. The prosthetic heart valve of claim 1, further comprising wherein the expandable stent has a low height to width profile.

4. The prosthetic heart valve of claim 1, further comprising wherein the expandable stent is a half-round D-shape in cross-section.

5. The prosthetic heart valve of claim 1, wherein the expandable stent is made from superelastic metal.

6. The prosthetic heart valve of claim 5, further comprising wherein the superelastic metal is a nickel-titanium alloy.

7. The prosthetic heart valve of claim 5, wherein the stent and cuff are formed from the same piece of superelastic metal.

8. The prosthetic heart valve of claim 1, further comprising wherein the expandable stent and collar are covered with stabilized tissue is derived from adult, 90-day old, or 30-day old, bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa.

9. The prosthetic heart valve of claim 1, further comprising wherein the expandable stent and collar are covered with synthetic material is selected from the group consisting of polyester, polyurethane, and polytetrafluoroethylene.

10. The prosthetic heart valve of claim 1, wherein the elastomeric material, stabilized tissue or synthetic material is treated with anticoagulant.

11. The prosthetic heart valve of claim 1, wherein the elastomeric material, the stabilized tissue or synthetic material is heparinized.

12. The prosthetic heart valve of claim 1, wherein the integral tether connection apparatus has a plurality of tether attachment structures with anchoring tethers attached for anchoring the prosthetic heart valve to tissue.

13. The prosthetic heart valve of claim 12, wherein at least one of the plurality of tethers is a positioning tether and at least one of the plurality of tethers is an anchoring tether.

14. The prosthetic heart valve of claim 12, further comprising wherein one of the plurality of tethers is attached to an epicardial tether securing device.

15. The prosthetic heart valve of claim 1, wherein the valve does not use an anchoring tether or a positioning tether, and is held in the mitral annulus by the wrapping forces of the native leaflets, and optionally one or more standard anchoring elements, including but not limited to barbs, pins and hooks, or combinations thereof.

16. The prosthetic heart valve of claim 1, wherein the anterior leaflet sealing device comprises a partial seal or a full circumferential ring seal attached to and hanging below the collar.

17. A method of treating mitral regurgitation in a patient, which comprises the step of surgically deploying the prosthetic heart valve of claim 1 into the mitral annulus of the patient.

18. The method of claim 17, wherein the prosthetic heart valve is deployed by directly accessing the heart through the intercostal space, using an apical approach to enter the left ventricle, and deploying the prosthetic heart valve into the mitral annulus using a catheter delivery system.

19. The method of claim 17, wherein the prosthetic heart valve is deployed by directly accessing the heart through a thoracotomy, sternotomy, or minimally-invasive thoracic, thorascopic, or trans-diaphragmatic approach to enter the left ventricle.

20. The method of claim 17, wherein the prosthetic heart valve is deployed by directly accessing the heart through the intercostal space, using an approach through the lateral ventricular wall to enter the left ventricle.

21-31. -31. (canceled)