TRANSLUMENALLY IMPLANTABLE HEART VALVE WITH FORMED IN PLACE SUPPORT

• US 20090088836A1
• Filed: 08/22/2008
• Published: 04/02/2009
• Est. Priority Date: 08/23/2007
• Status: Abandoned Application

• Current Assignee: Direct Flow Medical, Inc.
• Original Assignee: Direct Flow Medical, Inc.
• Inventors: Uong, Do, Lashinski, Randall T., Bishop, Gordon B.
• Application Number:
  US12/197,172
• Publication Number:
  US 20090088836A1
• Time in Patent Office: Days
• US Class Current: 623/2.100
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A cardiovascular prosthetic valve, the valve comprising an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure, and a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

Claims

1. A cardiovascular prosthetic valve, the valve comprising:

an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure; and

a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

2. The cardiovascular prosthetic valve of claim 1, further comprising a downstream support ring at the distal end of the inflatable cuff and an upstream support ring at the proximal end of the inflatable cuff.

3. The cardiovascular prosthetic valve of claim 2, wherein the plurality of tissue supports is coupled to the downstream support ring.

4. The cardiovascular prosthetic valve of claim 3, wherein the plurality of tissue supports are connected to the downstream support ring using a bioabsorbable suture or adhesive.

5. The cardiovascular prosthetic valve of claim 2, wherein the plurality of tissue supports is coupled to the upstream support ring.

6. The cardiovascular prosthetic valve of claim 5, further comprising a sleeve that extends between the distal to proximal support rings.

7. The cardiovascular prosthetic valve of claim 1, wherein the inflatable channel houses two end valves at each ends.

8. The cardiovascular prosthetic valve of claim 7, wherein the end valve comprises a sealing mechanism.

9. The cardiovascular prosthetic valve of claim 7, further comprising a directional valve between the ends of the inflation channel.

10. The cardiovascular prosthetic valve of claim 1, wherein each of the tissue supports comprises a first strut and a second strut joined to form an apex at the distal end of the inflatable cuff.

11. The cardiovascular prosthetic valve of claim 10, wherein the apex resides in contact with or adjacent a luminal side of a downstream support ring at the distal end of the inflatable cuff.

12. The cardiovascular prosthetic valve of claim 1, wherein the plurality of tissue supports is inflatable.

13. The cardiovascular prosthetic valve of claim 1, wherein the plurality of tissue supports is formed from a single strand solid element.

14. A method of implanting a prosthetic heart valve, the method comprising the steps of:

translumenally advancing a catheter carrying a prosthetic valve that comprises an inflatable support structure to a position proximate a native valve of a patient;

inflating a first chamber of the inflatable support structure with a contrast media;

visualizing the prosthetic valve under fluoroscopy;

displacing the contrast media in the first chamber of the inflatable support structure with a new inflation media; and

removing the catheter from the patient, leaving the prosthetic valve and the inflated first chamber of the inflatable support structure within the patient.

15. The method of claim 14, further comprising allowing the new inflation media to solidify within the first chamber of the inflatable support structure.

16. The method of claim 14, further comprising proximally retracting the valve after the first chamber is at least partially inflated.

17. The method of implanting a prosthetic valve as in claim 14, additionally comprising the step of removing the native valve prior to the removing the catheter step.

18. A cardiovascular prosthetic valve, the valve comprising:

an inflatable cuff comprising at least one inflatable channel that forms, at least in part, an inflatable structure, the inflatable channel including at least two valves positioned at ends of the inflatable channel; and

a valve coupled to the inflatable cuff, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction.

19. The cardiovascular prosthetic valve of claim 18, further comprising a directional valve positioned between the ends of the inflation channel.

20. The cardiovascular prosthetic valve of claim 18, further comprising a connector positioned adjacent each of the at least two valves for releasably coupling to an inflation tube.

21. A cardiovascular prosthetic valve, the valve comprising:

a support structure; and

a valve coupled to the support structure, the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction, the valve comprising a plurality of tissue supports that extend generally in the axial direction and that are flexible and/or movable throughout a range in a radial direction.

22. The cardiovascular prosthetic valve as in claim 21, wherein the tissue supports comprise a metallic material.

23. The cardiovascular prosthetic valve as in claim 21, wherein the tissue supports comprise at least one inflatable channel that forms, at least in part, an inflatable structure.

24. The cardiovascular prosthetic valve as in claim 21, wherein the support structure comprises a metallic material.

25. The cardiovascular prosthetic valve as in claim 21, wherein the support structure comprises at least one inflatable channel that forms, at least in part, an inflatable structure.