Replacement semilunar heart valves using flexible tubes

• US 6,092,529 A
• Filed: 02/03/1999
• Issued: 07/25/2000
• Est. Priority Date: 11/01/1993
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Cox, James L.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/288,998
• Time in Patent Office: 538 Days
• Field of Search: 623/2.11, 623/2.12, 623/900, 623/901, 128/898
• US Class Current: 128/898
• 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 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/3843 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: G06Q 40/04 Trading; Exchange, e.g. stocks, commodities, derivatives or currency exchange
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either "tacked" at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, including a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape. The synthetic tube is packaged within a sealed watertight enclosure that maintains sterility of the tube.

Claims

1. A method of surgically creating a replacement semilunar heart valve in a patient in need thereof, comprising the following steps:

a. providing a tubular segment of thin and flexible tissue or synthetic material having an inlet end and an outlet end;

b. surgically removing the cusps from a native semilunar heart valve, thereby generating an unoccupied valve annulus between the ventricular outflow artery and a ventricular chamber;

c. inserting into said artery the tubular segment having the inlet end, a thin and flexible wall portion having diametrically opposing sides, and the outlet end;

d. circumferentially securing the inlet end of the tubular segment to the unoccupied valve annulus; and

e. securing the tubular segment to the ventricular outflow artery at three spaced locations around the outlet end of the tubular segment, in a manner which creates three unconstrained regions between the three spaced locations at which the outflow end is secured, wherein the unconstrained regions are capable of flexing inwardly to function as semilunar cusps in the replacement semilunar heart valve.

2. The method of claim 1 wherein the tubular segment is inherently tubular, and is characterized by an absence of any longitudinal seams.

3. The method of claim 1 wherein the tubular segment consists essentially of synthetic material.

4. The method of claim 1 wherein the replacement semilunar heart valve is created without utilizing a stent or annuloplasty ring, wherein the tubular segment is sutured directly to the valve annulus.

5. The method of claim 1 wherein the replacement semilunar heart valve is created by utilizing an annuloplasty ring to provide a bridge between the valve annulus and the inlet end of the tubular segment.

6. The method of claim 1, additionally composing the step of surgically opening a ventricular outflow artery at a location adjacent to the native semilunar heart valve.