Intravascular Cuff

• US 20160051363A1
• Filed: 10/30/2015
• Published: 02/25/2016
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: HLT, Inc. (Bracco SPA)
• Inventors: Wilson, Robert Foster, Gainor, John P.
• Granted Patent: US 9,877,829 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

An intravascular cuff acts as a lining between a native vessel and an intravascular prosthetic device. During deployment, the ends of the cuff curl back upon themselves and are capable of trapping native tissue, such as valve leaflet tissue, between the ends. The cuff creates a seal between the vessel and the prosthetic, thereby preventing leakage around the prosthetic. The cuff also traps any embolic material dislodged from the vessel during expansion of the prosthetic.

Claims

5. An intravascular cuff for receiving a prosthetic, comprising:

at least one strand braided to form a tubular structure having an extended configuration and a deployed configuration;

whereby in the extended configuration, the tubular structure includes;

a first end and a second end;

a tubular body between the first end and the second end;

a lumen extending through the body;

whereby in the deployed configuration, the first and second ends assume an expanded shape relative to the tubular body; and

whereby upon deployment, an outer ply expands to conform against native tissue while the inner ply expands to open said lumen through said body, said lumen sized to receive a delivery catheter and having funnel-shaped ends for guiding said delivery catheter.

1. A method of preventing leakage between a prosthetic valve and a vessel wall comprising:

deploying a self-expanding mesh cuff having at least two-ply in the vessel prior to implanting the prosthetic valve, said mesh cuff including a center body portion and two end portions on either side of the center body portion;

allowing the end portions to expand and form a seal against the vessel wall while the center body portion of said cuff forms an open lumen;

implanting the prosthetic valve within said open lumen after the step of allowing the end portions to expand;

wherein at least one of said end portions mushrooms when expanded such that a gap is created between the plies of the end portions, thereby creating a funnel for guiding a delivery catheter into said open lumen in said cuff, and allowing an outer ply to conform against native tissue while an inner ply creates said funnel;

and wherein allowing the end portions to expand causes at least one of said end portions to fold.

2. The method of claim 1 further comprising expanding the prosthetic valve within the open lumen.

3. The method of claim 2 wherein expanding the prosthetic valve within the open lumen causes the body portion of the cuff to expand.

4. The method of claim 3 wherein causing the body portion to expand causes the body portion to shorten longitudinally.

6. The intravascular cuff for receiving a prosthetic of claim 5 wherein said lumen through said body has a uniform diameter in the deployed configuration.

7. The intravascular cuff for receiving a prosthetic of claim 5 wherein said at least one strand comprises a super-elastic material.

8. The intravascular cuff for receiving a prosthetic of claim 6 wherein said at least one strand comprises Nitinol.

9. The intravascular cuff for receiving a prosthetic of claim 5 whereby upon deployment, said first and second ends curl back on themselves.

10. The intravascular cuff for receiving a prosthetic of claim 5 wherein said tubular body between the first end and the second end comprises a two-ply body, formed by inverting said tubular body within itself to create a folded end and an unbraided end.

11. The intravascular cuff for receiving a prosthetic of claim 10 further comprising a material sandwiched between said first and second ply.

12. The material of claim 11 wherein said material is selected from the group consisting of non-woven material, woven material, braided fabric and polymer.

13. The intravascular cuff for receiving a prosthetic of claim 5 wherein the expanded shape of the ends comprises a mushroom shape defined by an outer ply and an inner ply separated by a gap.

14. The intravascular cuff for receiving a prosthetic of claim 5 wherein the tubular body between the first end and the second end retains a relatively unexpanded state in the deployed configuration.

15. The intravascular cuff for receiving a prosthetic of claim 5 wherein the tubular body shortens when expanded from the deployed state.

10-1. The intravascular cuff for receiving a prosthetic of claim 13 wherein the inner ply forms a funnel in the deployed configuration.

16. A method of preventing paravalvular leakage comprising:

placing a device having at least two ply within a target valve such that end portions of said device are located on either side of the target valve;

expanding an outer ply of at least end portion against the native tissue while an inner ply of the at least one end portion remains less expanded, thereby preventing the inner ply from interfering with the conformation of the outer ply of the at least one end portion;

whereby material joining the inner and outer plies of the at least one end portion form a funnel leading into a lumen of the device.

17. The method of claim 16 further comprising providing a material trapped between in the inner and outer plies.

18. The method of claim 16 wherein expanding the outer ply of the at least one end portion causes the outer ply to fold back on itself.

19. The method of claim 16 further comprising inserting a prosthetic within lumen of the device.

20. The method of claim 19 further comprising expanding the prosthetic within the lumen of the device.