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

• US 7,160,320 B2
• Filed: 04/11/2003
• Issued: 01/09/2007
• Est. Priority Date: 04/16/2002
• Status: Expired due to Fees

• Current Assignee: The International Heart Institute of Montana Foundation
• Original Assignee: The International Heart Institute of Montana Foundation
• Inventors: Duran, Carlos
• Primary Examiner(s): Isabella; David J.
• Application Number:
  US10/412,377
• Publication Number:
  US 20050055079A1
• Time in Patent Office: 1,369 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.13, 623 123- 126, 623 132- 136, 623902-903, 623/909, 623/916, 623/921, 623/925, 623/2.1, 623 212- 219, 623 233- 242, 128/898, 600/36
• 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 2/2427 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. A process of surgically implanting an intravascular one-way valve having a plurality of leaflets, to serve as a prosthesis for a diseased native valve of a mammal, 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, 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 member having an inflow orifice and an outflow orifice, the leaflets forming the outflow orifice and forming a plurality of commissures;

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 member 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 commissures to form a circle around the tubular member in proximity of the outflow orifice the valve.

2. A process in accordance with claim 1 additionally comprising the step of severing the first stent and removing it from the valve being implanted.

3. A process in accordance with claim 1 additionally comprising the step of severing the second stent and removing it from the valve being implanted.

4. A process in accordance with claim 1 additionally comprising the steps of severing the first and second stents and removing them from the valve being implanted.