Devices, systems, and methods to optimize annular orientation of transcatheter valves

• US 10,869,756 B2
• Filed: 03/10/2016
• Issued: 12/22/2020
• Est. Priority Date: 03/12/2015
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Al-Jilaihawi, Hasanian
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/554,691
• Publication Number:
  US 20180078363A1
• Time in Patent Office: 1,748 Days
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/007 O-rings

Abstract

In various embodiments, provided herein are methods, devices and systems to optimize annular orientation of transcatheter valves and thereby facilitate transcatheter aortic valve replacement in the setting of challenging cardiovascular anatomy. These methods, devices and systems are used to treat patients with valvular diseases. To solve these problems, described herein is a Device to Optimize aNnUlar orientation of Transcathether valves (DONUT). DONUT can correct large differences between a native valve'"'"'s anatomical dimensions and the external dimensions of a transcatheter valve stent frame.

Claims

1. A device for transcatheter valve replacement, comprising:

a ring-shaped article comprising a stent frame, wherein the stent frame comprises an inflatable hollow plastic external layer,

wherein the ring-shaped article comprises an outside surface,

wherein the outside surface comprises an inward surface area that faces toward the center of the ring-shaped article and forms a center hole,

wherein the outside surface comprises an outward surface area that faces away from the center hole of the ring-shaped article and forms a periphery,

wherein the ring-shaped article has a compressed status and an expanded status;

wherein when the ring-shaped article is expanded, the center hole is configured to fit and receive a replacement heart valve, and the periphery is configured to act as a mould to a native anatomy of a heart valve peri-annular region, cardiovascular structure or chamber.

2. The device of claim 1, wherein the heart valve is a mitral, aortic, tricuspid or pulmonary valve.

3. The device of claim 1, wherein the periphery is configured to anchor to the heart valve peri-annular region or the periphery is configured to anchor to the ventricular, atrial, aortic, or arterial wall.

4. The device of claim 1, wherein the replacement heart valve is configured to anchor to the center hole of the ring-shaped article.

5. The device of claim 1, wherein the ring-shaped article and the replacement heart valve are not connected to each other.

6. The device of claim 1, wherein,

the replacement heart valve is about 10-55 mm in height;

the ring-shaped article is about 5-55 mm in height;

the replacement heart valve is about 10-55 mm in diameter;

the center hole of the ring-shaped article is about 10-55 mm in diameter; and

the periphery of the ring-shaped article is about 15-80 mm in diameter.

7. The device of claim 1, wherein the center hole of the ring-shaped article is shaped as circular, elliptical, oval, or a D ring and the periphery of the ring-shaped article is shaped to conform to the region in which the device is deployed.

8. The device of claim 1, wherein the cross section of the replacement valve is a circle, ellipse, oval, or D-shape.

9. The device of claim 1, wherein the ring-shaped article is self-expandable or balloon expandable.

10. The device of claim 1, wherein the ring-shaped article comprises a frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material.

11. The device of claim 1, wherein the replacement heart valve is self-expandable or balloon expandable.

12. The device of claim 1, wherein the replacement valve comprises a stent frame made of iron, platinum, titanium, nickel, chromium, cobalt, magnesium, stainless steel, nitinol (nickel-titanium), nickel-chromium, cobalt-chromium, or platinum-iridium, or a combination thereof, or of a solid or hollow plastic material.

13. The device of claim 1, wherein the replacement heart valve is a prosthetic valve or a bioprosthetic valve.

14. The device of claim 1, wherein the replacement valve comprises one, two, three, or more leaflets.

15. The device of claim 1, further comprising the replacement heart valve.

16. The device of claim 1, further comprising a first delivery catheter, wherein the first delivery catheter is configured to deploy the ring-shaped article into the heart valve peri-annular region.

17. The device of claim 16, wherein the first delivery catheter comprises an inflatable balloon near or at its distal end, wherein the ring-shaped article is configured to be mounted on the inflatable balloon when compressed, and wherein the inflatable balloon is configured to be inflated so as to expand the ring-shaped article when compressed.

18. The device of claim 17, further comprising a second delivery catheter, wherein the second delivery catheter is configured to deploy the replacement heart valve into the center hole of the ring-shaped article.

19. The device of claim 18, further comprising a guide wire, wherein the second delivery catheter is configured to be inserted over the guide wire.

20. The device of claim 16, wherein the first delivery catheter comprises an enclosing sheath near or at its distal end, wherein the ring-shaped article is configured to be enclosed in the enclosing sheath when compressed, and wherein the enclosing sheath is configured to be retracted so as to expand the ring-shaped article.

21. The device of claim 16, further comprising a guide wire, wherein the first delivery catheter is configured to be inserted over the guide wire.