Heart valve replacement using flexible tubes

• US 5,480,424 A
• Filed: 11/01/1993
• Issued: 01/02/1996
• Est. Priority Date: 11/01/1993
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: James L. Cox
• Inventors: Cox, James L.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/146,938
• Time in Patent Office: 792 Days
• Field of Search: 206/438, 623/2, 623/900
• US Class Current: 623/2.15
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3629 Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

This invention comprises a method of using tubular material to replace a heart valve during cardiac surgery. To create a replacement atrioventricular (mitral or tricuspid) valve, the tube inlet is sutured to a valve annulus from which the native leaflets have been removed, and the tube outlet is sutured to papillary muscles in the ventricle. To create a semilunar (aortic or pulmonary) valve, the tube inlet is sutured to an annulus from which the native cusps have been removed, and the tube is either "tacked" at three points distally inside the artery, or sutured longitudinally along three lines; this allows the flaps of tissue between the three fixation points at the valve outlet to function as movable cusps. These approaches generate flow patterns that closely duplicate the flow patterns of native valves. A preferred tubular material comprises submucosal tissue from the small intestine of the same patient who is undergoing the cardiac operation. By using tissue from the same patient, the risk of immune rejection and the need to treat the tissue to reduce antigenicity are eliminated. Animal or human cadaver intestinal tissue can also be used if properly treated, or a biocompatible synthetic tubular material can be used. This invention also discloses a properly treated intestinal tissue segment or synthetic tubular segment suitable for implantation as a replacement heart valve, enclosed in a sealed sterile package.

Claims

1. An article of manufacture comprising a sealed container and an enclosed intestinal tissue segment suitable for surgical implantation as a replacement valve in a mammalian heart, wherein:

(a) the intestinal tissue segment has been harvested from a small intestine of a mammalian species selected from the group consisting of humans, and genetically-engineered hypoallergenic pigs;

(b) the intestinal tissue segment remains in a tubular form which facilitates surgical implantation of the segment as a replacement valve in a heart without requiring a longitudinal suture to convert the segment into tubular form for implantation;

(c) the intestinal tissue segment is sufficiently long to allow it to be surgically implanted as a replacement valve in a heart in a human patient; and

,

(d) the sealed container encloses and maintains sterility of the intestinal tissue segment.

2. The article of manufacture of claim 1, wherein the tissue segment has been chemically treated to reduce its antigenicity.

3. The article of manufacture of claim 1, wherein the intestinal tissue segment has been treated to remove serosal, muscularis, and mucosal layers of intestinal tissue.

4. The article of manufacture of claim 1, wherein the sealed container also contains a suitable liquid which keeps the intestinal tissue segment in hydrated form.

5. The article of manufacture of claim 1, wherein the sealed container allows visual inspection of the tissue segment through at least one side of the container which comprises transparent plastic.

6. The article of manufacture of claim 1, wherein the sealed container comprises a label which indicates an average diameter of the intestinal tissue segment.

7. The article of manufacture of claim 1, wherein the tissue segment is attached at one end to an annuloplasty ring.