Sigmoid valve and method for its percutaneous implantation

• US 20040215333A1
• Filed: 04/11/2003
• Published: 10/28/2004
• 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, Sanz, Mark
• Granted Patent: US 7,125,418 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 incorporated in self-expandable or inflatable endovascular stents or stents to form a combination which is introduced on a catheter with a guide wire into the circulatory system of the mammal to replace the diseased native valve. Once the combination is at the desired location the stent is caused to expand and affix itself to the patient'"'"'s vessel wall. The prosthetic 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 circular support is affixed in a substantially circular fashion around the truncated cone in proximity of the inflow orifice, and a second flexible circular support is affixed at the location of the commissures to form a circle around the truncated cone in proximity of the outflow orifice. The circular supports maintain the shape of the valve during the surgical implantation procedure and thereafter.

Claims

1. A combination of an endovascular stent with an intravascular multi-leaflet, one-way valve to serve as a prosthesis for diseased native valve of a mammal, the combination being adapted for percutaneous delivery, and comprising:

(1) a valve including 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 encircling support consisting essentially of material selected from the group consisting of thin metal wire, thin plastic ring, or suture filament, said first encircling support being affixed in a substantially circular fashion around the tubular body in proximity of the inflow orifice, and

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

(2) an endovascular stent larger in diameter than the valve, the valve being contained in the endovascular stent and attached to the endovascular stent by affixing the inflow orifice of the valve to the endovasular stent and by affixing the second encircling support to the endovascular stent.

2. A combination in accordance with claim 1 where the endovascular stent includes an outwardly extended bulge in the area where the valve is attached within the endovacular stent.

3. A combination in accordance with claim 2 wherein the bulge of the endovascular stent comprises material of the endovascular stent that is longer than the length of the valve and that is held as the bulge by sutures placed at the inflow and outflow orifices of the valve.

4. A combination in accordance with claim 1 where the endovascular stent is collapsible and self-expandable.

5. A combination in accordance with claim 1 where the endovascular stent is collapsible and balloon inflatable.

6. A combination in accordance with claim 1 wherein the valve is a tri-leaflet valve.

7. A combination in accordance with claim 1 wherein the valve is a bi-leaflet valve.

8. A combination in accordance with claim 1 where the valve is attached to the endovascular stent by sutures.

9. A combination in accordance with claim 1 where the valve further comprises a plurality of members interconnecting the first and second circular supports, the length of the interconnecting members determining the maximum height of the valve.

22. A method of percutaneously implanting a prosthetic valve into the circulatory system of a mammal to replace a diseased native valve, the method comprising the steps of:

collapsing a combination of an endovascular stent with an intravascular multi-leaflet, one way valve as described in claim 1 on a catheter led by a guide wire;

introducing the combination to a desired place of destination in the circulatory system by pushing said collapsed combination with the catheter on the guide wire;

causing the combination to expand and lodge itself in the desired place of destination in the circulatory system, and

withdrawing the catheter and the guide wire.

23. A method in accordance with claim 22 wherein the collapsed combination further includes an inflatable ballon, and wherein the step of causing the combination to expand comprises inflating the balloon.

24. A method in accordance with claim 22 wherein the endovascular stent of the combination is self-expandable.

10. A combination of two endovascular stents with an intravascular multi-leaflet, one-way valve to serve as a prosthesis for diseased native valve of a mammal, the combination being adapted for percutaneous delivery, and comprising:

(1) a valve including 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 encircling support consisting essentially of material selected from the group consisting of thin metal wire, thin plastic ring, or suture filament, said first encircling support being affixed in a substantially circular fashion around the tubular body in proximity of the inflow orifice, and

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

(2) a first endovascular stent larger in diameter than the valve, the valve being attached to the first endovascular stent by affixing the inflow orifice of the valve to the first endovascular stent;

(3) a second endovascular stent larger in diameter than the valve, the valve being attached to the second endovascular stent by affixing the second encircling support to the second endovascular stent.

11. A combination in accordance with claim 10 where the first and second endovascular stents are collapsible and self-expandable.

12. A combination in accordance with claim 10 where the first and second endovasular stents are collapsible and balloon inflatable.

13. A combination in accordance with claim 10 wherein the valve is a tri-leaflet valve.

14. A combination in accordance with claim 10 wherein the valve is a bi-leaflet valve.

15. A combination in accordance with claim 10 where the valve is attached to the first and second endovascular stents by sutures.

16. A combination in accordance with claim 10 where the valve further comprises a plurality of members interconnecting the first and second circular supports, the length of the interconnecting members determining the maximum height of the valve.

18. A combination in accordance with claim 16 where each of the sleeves is formed of DACRON™

material.

25. A method of percutaneously implanting a prosthetic valve into the circulatory system of a mammal to replace a diseased native valve, the method comprising the steps of:

collapsing a combination of two endovascular stents with an intravascular multi-leaflet, one way valve as described in claim 10 on a catheter led by a guide wire;

introducing the combination to a desired place of destination in the circulatory system by pushing said collapsed combination with the catheter on the guide wire;

causing the combination to expand and lodge itself in the desired place of destination in the circulatory system, and

withdrawing the catheter and the guide wire.

17. A combination of two sleeves with an intravascular multi-leaflet, one-way valve to serve as a prosthesis for diseased native valve of a mammal, the combination being adapted for percutaneous delivery, and comprising:

(1) a valve including 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 encircling support consisting essentially of material selected from the group consisting of thin metal wire, thin plastic ring, or suture filament, said first encircling support being affixed in a substantially circular fashion around the tubular body in proximity of the inflow orifice, and

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

(2) a first sleeve larger in diameter than the valve, the valve being attached to the first sleeve by affixing the inflow orifice of the valve to the first sleeve;

(3) a second sleeve larger in diameter than the valve, the valve being attached to the second sleeve by affixing the second encircling support to the second sleeve, each of the sleeves having an exterior surface and a plurality of hooks attached to the exterior surfaces, the hooks being adapted for anchoring the combination to the vessel wall of a patient.

19. A combination in accordance with claim 17 wherein the valve is a bi-leaflet valve.

20. A combination in accordance with claim 17 where the valve is attached to the endovasular stent by sutures.

21. A combination in accordance with claim 17 where the valve further comprises a plurality of members interconnecting the first and second circular supports, the length of the interconnecting members determining the maximum height of the valve.

26. A method of percutaneously implanting a prosthetic valve into the circulatory system of a mammal to replace a diseased native valve, the method comprising the steps of:

collapsing a combination of two sleeves with an intravascular multi-leaflet, one way valve as described in claim 17 on a catheter led by a guide wire;

introducing the combination to a desired place of destination in the circulatory system by pushing said collapsed combination with the catheter on the guide wire;

causing the combination to expand and lodge itself in the desired place of destination in the circulatory system, and

withdrawing the catheter and the guide wire.