Replacement heart valve, valve holder and methods of making same

• US 8,790,397 B2
• Filed: 07/13/2011
• Issued: 07/29/2014
• Est. Priority Date: 04/23/2007
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Megumi Mathison
• Inventors: Mathison, Megumi
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US13/182,170
• Publication Number:
  US 20110265329A1
• Time in Patent Office: 1,112 Days
• Field of Search: 623/1.24, 623/2.1, 623/1.26
• US Class Current: 623/2.13
• 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 2240/001 Designing or manufacturing processes
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

A replacement heart valve device usable in a medical procedure in relation in heart valve replacement of a patient. In one embodiment, the replacement heart valve device includes a heart valve holder or conduit holder formed in the form of a cylindrical tube having a longitudinal cut substantially extending from one end to the other end of the cylindrical tube, and a conduit formed with a tubular segment of an elastic material. The conduit is mountable onto the heart valve holder or conduit holder or self-expanding stent. In one embodiment, at least a portion of the conduit is formed with a single layer of the elastic material. In another embodiment, at least a portion of the conduit is formed with two layers of the elastic material.

Claims

1. A method of forming a replacement heart valve that is implantable to a patient, comprising the steps of:

providing a continuous tubular segment of mammalian elastic material having a first end portion and an opposite, second end portion, a first interior surface, a first exterior surface, a longitudinal axis, and a diameter d₁;

forming a first valve conduit with said tubular segment by folding said first end portion inside-out towards said second end portion, wherein said first end of said tubular segment extends to a first position on said first exterior surface and forms a folded first end portion, said folded first end portion comprising top and bottom layers of said mammalian elastic material, said first folded end portion further having an axial distance d₂ that is substantially equals to d₁;

forming a plurality of cusps on said folded first end portion, wherein a second valve conduit is formed, said second valve conduit having a second interior surface and a second exterior surface, said plurality of cusps extending axially on said folded first end portion, said plurality of cusps being formed solely by stitching said top and bottom folded first end portion layers along substantially parallel lines that correspond to said longitudinal axis; and

inverting said second valve conduit inside-out, wherein said second exterior surface and said second interior surface of said second valve conduit exchange geometric positions.

2. The method of claim 1, wherein said mammalian elastic material comprises intestinal tissue obtained from a mammalian abdomen.

3. The method of claim 1, wherein said plurality of cusps comprises three cusps.

4. The method of claim 1, wherein said cusps are formed substantially parallel to each other and spaced 120°

apart from each other on said first formed end portion.