Reed valve for implantation into mammalian blood vessels and heart with optional temporary or permanent support

• US 20050055079A1
• Filed: 04/11/2003
• Published: 03/10/2005
• Est. Priority Date: 04/16/2002
• Status: Active Grant

• Current Assignee: The International Heart Institute of Montana Foundation
• Original Assignee: The International Heart Institute of Montana Foundation
• Inventors: Duran, Carlos
• Granted Patent: US 7,160,320 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A multi-leaflet valve adapted to serve as a prosthesis for diseased native valve of a mammal is constructed of biologic membrane or of biocompatible synthetic membrane. The valve has the shape of a truncated cone that has an inflow and an outflow orifice with leaflets forming the outflow orifice and forming a plurality of commissures. A first flexible stent is removably affixed in a substantially circular fashion around the truncated cone in proximity of the inflow orifice, and a second flexible stent is removably affixed at the location of the commissures to form a circle around the truncated cone in proximity of the outflow orifice. The stents maintain the shape of the valve during the surgical implantation procedure. Each stent independently can be left in the valve or can be removed during the implantation procedure based upon the judgement of the cardiac surgeon performing the implantation procedure. A holder designed to maintain the geometry of the valve during implantation to a mammal is also disclosed.

Claims

1. An intravascular multi-leaflet, one-way valve to serve as a prosthesis for diseased native valve of a mammal, the valve comprising:

a tubular member formed of one of a naturally occurring tubular body channel and of a membrane, the membrane being selected from a group of materials consisting of biocompatible polymer and biologic flat membrane, said membrane configured as a truncated cone, the tubular body having an inflow orifice and an outflow orifice, the leaflets forming the outflow orifice and forming a plurality of comissures;

a first flexible stent consisting essentially of material selected from the group consisting of thin metal wire, thin plastic ring, or suture filament, said first stent being removably affixed in a substantially circular fashion around the tubular body in proximity of the inflow orifice, and

a second flexible stent consisting essentially of material selected from the group consisting of thin metal wire, thin plastic ring, or suture filament, said second stent being removably affixed at the location of the comissures to form a circle around the tubular body in proximity of the outflow orifice.

2. The valve in accordance with claim 1 which is a tri-leaflet valve.

3. The valve in accordance with claim 1 which is a bi-leaflet valve.

4. The valve in accordance with claim 1 wherein the tubular body is formed of a membrane.

5. The valve in accordance with claim 4 where the membrane is selected from the group of materials consisting of pericardium, pleura, peritoneum and dura mater.

6. The valve in accordance with claim 1 wherein the tubular body is formed of a naturally occurring tubular body channel.

7. The valve in accordance with claim 6 wherein the tubular body channel is of autologous, homologous or heterologous origin and is selected from the group consisting of arteries, veins and gut.

8. The valve in accordance with claim 1 wherein the first and second stents each essentially consist of suture filament.

9. The valve in accordance with claim 8 wherein the suture filament is polypropylene filament.

10. The valve in accordance with claim 1 additionally comprising a plurality of members interconnecting the first and second stents and being removably affixed to said stents, the length of the interconnecting members determining the maximum height of the valve.

11. The valve in accordance with claim 10 where the interconnecting members are affixed to the second stent at the locations of the commissures.

12. The valve in accordance with claim 11 where the interconnecting members comprise material selected from the group consisting of thin biocompatible wire and thin biocompatible plastic.

13. A holder designed to maintain the geometry of the valve of claim 1 during implantation to a mammal, the holder comprising:

a handle;

a rod affixed to the handle;

a first and a second substantially circular member, the first circular member being fixedly positioned on the rod and the second circular member being affixed to the rod and movable thereon for a predetermined length, the first circular member being capable of receiving removable attachment of the first stent of the valve and the second circular member being capable of receiving removable attachment of the second stent of the valve.

14. A holder in accordance with claim 13 wherein the diameter of each circular member is variable.

15. A holder in accordance with claim 13 wherein the first circular member is smaller in diameter than the first stent of the valve with which the holder is to be used, and wherein the second circular member is smaller in diameter than the second stent of the valve with which the holder is to be used, whereby the holder is adapted to be placed into the valve.

16. A holder in accordance with claim 15 wherein the first and second circular members each comprise a spiral ring of variable diameter.

17. A holder in accordance with claim 13 wherein the first and second circular members each comprise a spiral ring of variable diameter.

18. A holder in accordance with claim 13 wherein the first and second circular members each comprise a disk.

19. A holder in accordance with claim 13 wherein the first and second circular members each comprise a ring of diameters larger than the diameters of the respective stents of the valve with which the holder is to be used, whereby the holder is adapted to receive the valve placed thereinto.

20. A process of surgically implanting a valve defined in claim 1 into the blood vessel of a mammal in need of such implantation, the process comprising the steps of:

suturing the inflow orifice of the valve into a base in a blood vessel of the mammal, and

suturing the outflow orifice to the mammal'"'"'s blood vessel only at the comissures.

21. A process in accordance with claim 20 additionally comprising the step of severing the first stent and removing it from the valve being implanted.

22. A process in accordance with claim 20 additionally comprising the step of severing the second stent and removing it from the valve being implanted.

23. A process in accordance with claim 20 additionally comprising the steps of severing the first and second stents and removing them from the valve being implanted.