Method of replacing heart valves using flexible tubes

• US 5,713,950 A
• Filed: 06/02/1995
• Issued: 02/03/1998
• Est. Priority Date: 11/01/1993
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: Respicardia, Inc. (Asahi Kasei Corporation)
• Inventors: Cox, James L.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/459,979
• Time in Patent Office: 977 Days
• Field of Search: 623/1, 623/2, 623/66, 623/900, 623/901, 435/238
• 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

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. One preferred tubular material comprises submucosal tissue from a small intestine, from the same patient who is undergoing the cardiac operation; this eliminates the risk of immune rejection and the need to treat the tissue to reduce antigenicity. Intestinal tissue from human cadavers or animals such as genetically engineered hypoallergenic pigs can also be used, if properly treated, or a biocompatible synthetic tubular material can be used.

Claims

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

a. extracting a tubular segment of intestinal tissue from a mammalian abdomen;

b. trimming the tubular segment of intestinal tissue to a size which provides a surgically-implantable segment of intestinal tissue; and

,

c. surgically securing the surgically-implantable segment of intestinal tissue in the patient, in a position originally occupied by a native heart valve which has been removed, in a manner which causes the intestinal tissue to form a replacement heart valve.

2. The method of claim 1 wherein the surgically-implantable segment of intestinal tissue is used to replace an atrioventricular heart valve having at least two leaflets, wherein a first end of the segment of intestinal tissue is secured to an atrioventricular valve annulus, and wherein a second opposing end of the segment of intestinal tissue is trimmed to provide leaflets which are secured to papillary muscles in a manner which generates a valve outlet end.

3. The method of claim 2 wherein the intestinal tissue is used to replace a mitral valve in a ventricular chamber having an anterior papillary muscle and a posterior papillary muscle, and wherein the intestinal tissue is secured to the anterior papillary muscle and the posterior papillary muscle in a manner that generates an anterior leaflet and a posterior leaflet which, during valve closure, form a line of commissure which closely approximates a natural line of commissure formed by native atrioventricular leaflets during valve closure.

4. The method of claim 2 wherein the first end of the segment of intestinal tissue is secured to the atrioventricular valve annulus using an annuloplasty ring.

5. The method of claim 1 wherein the intestinal tissue is extracted from the patient who receives the replacement heart valve.

6. The method of claim 1 wherein the intestinal tissue is kept in tubular form throughout all steps of extraction, trimming, and surgical implantation.

7. The method of claim 6 wherein the surgically-implantable segment of intestinal tissue is used to replace an atrioventricular heart valve having at least two leaflets, wherein the first end of the segment of intestinal tissue is secured to an atrioventricular valve annulus, and wherein the second opposing end of the segment of intestinal tissue is trimmed to provide leaflets which are secured to papillary muscles in a manner which generates a valve outlet end.

8. The method of claim 1 wherein the surgically-implantable segment of intestinal tissue is secured inside a stent in a manner which generates a cusp in a semilunar replacement valve.

9. The method of claim 1 wherein the surgically-implantable segment of intestinal tissue is used to replace a semilunar valve inside an arterial wall adjacent to a heart, by steps comprising:

a. securing a first end of the surgically-implantable segment of intestinal tissue to a valve annulus from which native semilunar cusps have been removed;

b. securing a second opposing end of the surgically-implantable segment of intestinal tissue to the arterial wall at three constraint locations positioned approximately equidistantly around the second end of the intestinal tissue, in a manner which creates three intestinal tissue flaps positioned between the three constraint locations, in a manner which allows the three intestinal tissue flaps to flex inwardly, inside the arterial wall adjacent to the heart, and thereby function as semilunar cusps during opening and closure of the semilunar replacement valve.

10. The method of claim 9 wherein the intestinal tissue is extracted from the patient who receives the replacement heart valve.