Leaflet valve

• US 8,163,008 B2
• Filed: 02/25/2008
• Issued: 04/24/2012
• Est. Priority Date: 08/28/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Heart Leaflet Technologies, Inc. (Bracco SPA)
• Inventors: Wilson, Robert Foster, Wilson, Scott Robert, Pokorney, James L.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US12/037,025
• Publication Number:
  US 20080147105A1
• Time in Patent Office: 1,520 Days
• Field of Search: 606/184, 606/185, 606/170, 606/174, 606/180, 606/167, 600/562, 600 16- 18, 600/37, 623/2.11, 623/904
• US Class Current: 623/2.11
• 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 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A device and method for improving flow through a native blood vessel valve, such as the aortic valve, are provided. The present invention allows a miniature valve to be implanted into affected leaflets percutaneously, obviating the need for coronary bypass surgery. The method includes the cutting of small holes, on the order of 4 mm, in the leaflets of a targeted valve, thereby allowing blood to flow through the newly formed holes. The holes are used as attachment sites for the miniature valves of the present invention.

Claims

1. A heart valve, transluminally deliverable via a catheter, comprising:

a mesh housing; and

,

a flow control mechanism of biologic tissue coupled to said housing, said flow control mechanism including passive leaflets, free from biasing mechanisms;

said housing including an anchoring mechanism having at least one end free to extend radially to affix the heart valve to tissue of a leaflet of a native heart valve;

wherein said mesh housing is adapted to be compressed into the catheter for transluminal delivery, and to expand to a desired diameter upon deployment from said catheter.

2. A heart valve according to claim 1, wherein said at least one end comprises an expandable cuff for engaging a leaflet of a native human heart valve.

3. A heart valve according to claim 2, wherein said cuff includes a plurality of radial extensions extending from said cuff and engageable with said leaflet of a native heart valve so as to secure said cuff in said leaflet of a native heart valve.

4. A heart valve according to claim 1, wherein said flow control mechanism comprises a sleeve containing a plurality of valve members.

5. A heart valve according to claim 4, wherein said plurality of valve members includes leaflets disposed on a stent form.

6. The heart valve of claim 1, wherein said mesh housing is comprised of Nitinol.

7. The heart valve of claim 1, wherein said anchoring mechanism includes an upstream and downstream component for further fixating said housing.

8. The heart valve of claim 7, wherein said upstream and downstream components fold outwardly when released.

9. A device, transluminally deliverable via a catheter, to increase fluid flow through a mammalian valve comprising:

a valve mechanism, of biologic tissue, containing a lumen therein;

said valve mechanism actuatable so as to place said lumen in one of an open and closed state;

said valve mechanism including leaflets that are passive, influenced to one of said open and closed states only by fluid flow; and

,

a housing connected to said valve mechanism;

said housing including an anchoring structure with an end free to extend radially against tissue of a leaflet of said mammalian valve;

wherein said housing is constructed of mesh, allowing the housing to be compressed into a catheter for delivery and expands to a desired diameter upon deployment from said catheter.

10. The heart valve of claim 9, wherein said housing is comprised of Nitinol.

11. The heart valve of claim 9, wherein said anchoring structure includes an upstream and downstream component for further fixating said housing structure.

12. The heart valve of claim 11, wherein said upstream and downstream components fold outwardly when released.

13. A valve device, transluminally deliverable via a catheter, for treating a diseased valve comprising:

a fluid flow control element comprised of biologic tissue, said fluid flow control element including passive leaflets, free from biasing mechanisms;

a housing structure constructed of a stiff fabric and having an outwardly radiating free end for anchoring said fluid flow control element adjacent to tissue of a native valve leaflet;

said fluid flow control element and said stiff fabric structure being connected to each other.

14. The heart valve of claim 13, wherein said mesh housing structure is comprised of Nitinol.

15. A valve device according to claim 13, wherein said housing structure includes a cuff.

16. A valve device according to claim 13, wherein said housing structure is expandable and includes a constraining device for constraining the expansion of said stiff fabric structure.

17. A heart valve, transluminally deliverable via a catheter, comprising:

a compressible and expandable housing with a free end extending radially from at least one of two opposite ends of said stiff fabric body; and

a prosthetic valve comprised of biologic material attached to an inside surface of said housing, said prosthetic valve including passive leaflets, free from biasing mechanisms, said housing constructed of a stiff fabric.

18. A heart valve, transluminally deliverable via a catheter, comprising:

a housing structure;

a flow control mechanism coupled to said position securement structure, said flow control mechanism including passive leaflets, free from biasing mechanisms;

said mesh housing having a position securement structure including an end that is free to radiate outwardly to engage a surface of a leaflet of a native heart valve;

wherein said housing structure comprises a mesh tube, allowing said entire housing structure to be expandable and collapsible.