DEVICE AND SYSTEM FOR TRANSCATHETER MITRAL VALVE REPLACEMENT

• US 20160262881A1
• Filed: 05/24/2016
• Published: 09/15/2016
• Est. Priority Date: 12/08/2009
• Status: Active Grant

• Current Assignee: Avalon Medical, Ltd., Colorado State University Research Foundation (Colorado State University System)
• Original Assignee: Avalon Medical, Ltd., Colorado State University Research Foundation (Colorado State University System)
• Inventors: SCHANKERELI, Kemal, ORTON, E. Christopher
• Granted Patent: US 11,179,236 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

This invention relates to the design and function of a compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Claims

1. An apparatus, comprising:

a self-expanding prosthetic heart valve having a tubular body, a leaflet structure disposed within a lumen of the tubular body, a cuff extending from the tubular body, and a cuff covering disposed on the cuff,

the cuff including a plurality of radially extending loops collectively defining a collar shape and defining circumferential spaces between adjacent loops, the collar having a distal-facing side and a proximal-facing side,

the cuff covering at least one of the distal-facing side and the proximal facing side of the collar and extending between the radially outer ends of the loops across all of the circumferential spaces.

2. The apparatus of claim 1, wherein the cuff covering is configured to permit the loops to articulate independently to conform to contours of an annulus of a native mitral or tricuspid valve.

3. The apparatus of claim 1, wherein the loops have different lengths, defining an elongated collar.

4. The apparatus of claim 1, wherein the cuff covering covers both the distal-facing side and the proximal-facing side of the collar and the radially outer ends of the loops.

5. The apparatus of claim 1, wherein the cuff covering covers both the distal-facing side and the proximal-facing side of the collar and defines a peripheral edge of the cuff that is spaced radially outwardly from the radially outer ends of the loops.

6. The apparatus of claim 1, wherein the cuff covering is formed at least in part of a biocompatible synthetic material.

7. The apparatus of claim 1, wherein the loops are formed of a superelastic metal.

8. The apparatus of claim 7, wherein the superelastic material is a nickel-titanium alloy.

9. The apparatus of claim 1, wherein each of the loops has a length that is different from an adjacent loop.

10. The apparatus of claim 1, wherein the cuff covering is formed of cross-linked stabilized tissue.

11. The apparatus of claim 10, wherein the stabilized tissue is treated with anticoagulant.

12. The apparatus of claim 10, wherein the stabilized tissue is heparinized.

13. The apparatus of claim 10, wherein the stabilized tissue has a thickness ranging from about 0.0762 mm and 0.254 mm.

14. The apparatus of claim 10, wherein said stabilized tissue is derived from bovine, ovine, equine, or porcine pericardium, or from animal small intestinal submucosa.

15. The apparatus of claim 1, wherein the collar forms an angle with respect to the tubular body in a range of between about 60 degrees and about 150 degrees when deployed.

16. The apparatus of claim 1, wherein the cuff is configured to form an atrially-located anchor for the valve without the need for any additional atrial anchoring.

17. The apparatus of claim 1, wherein the loops are formed of a superelastic metal.

18. The apparatus of claim 1, wherein the tubular body and the cuff are integrally formed.

19. The apparatus of claim 1, further comprising at least one tether coupled to the tubular body for anchoring the prosthetic valve to tissue.

20. An apparatus, comprising:

a self-expanding prosthetic heart valve having a tubular body, a leaflet structure disposed within a lumen of the tubular body, a single cuff extending from the tubular body, and a cuff covering disposed on the cuff,

the cuff including a plurality of radially extending loops and defining circumferential spaces between adjacent loops, the collar having a distal-facing side and a proximal-facing side,

the cuff covering the entirely of the distal-facing side and the proximal facing side of the collar and extending between the radially outer ends of the loops across all of the circumferential spaces.

21. The apparatus of claim 20, wherein the cuff covering covers both the distal-facing side and the proximal-facing side of the collar and defines a peripheral edge of the cuff that is spaced radially outwardly from the radially outer ends of the loops.

22. The apparatus of claim 20, wherein the cuff is configured to form an atrially-located anchor for the valve without the need for any additional atrial anchoring.

23. The apparatus of claim 20, wherein the tubular body and the cuff are integrally formed.

24. The apparatus of claim 20, further comprising at least one tether coupled to the tubular body for anchoring the prosthetic valve to tissue.

25. The apparatus of claim 20, further comprising at least one tether having a first end coupled to the tubular body and a second end, the second end configured to extend through a wall of a ventricle of a heart and to be anchored to the epicardium of the heart, and to withstand ventricular force on the prosthetic heart valve during systole when the tubular body is disposed in the annulus of a native heart valve associated with the ventricle and the cuff is seated in the atrium associated with the ventricle.