Processing

Please wait...

Settings

Settings

Goto Application

1. WO1997024082 - HEART VALVE REPLACEMENT USING FLEXIBLE TUBES

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

[ EN ]

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, non-human primates, 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.

8. A method of surgically replacing an atrioventricular heart valve in a human patient in need thereof, comprising the
following steps:
a. extracting a segment of intestinal tissue from a mammalian abdomen; and,
b. using the intestinal tissue to form at least one component of the replacement valve for the patient's heart.

9. The method of Claim 8, wherein the intestinal tissue is secured at one end to an atrioventricular valve annulus, and at the other end to papillary muscles, in a manner which generates an outlet end that replicates both form and function of native atrioventricular leaflets.

10. The method of Claim 9 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 sutured to both papillary muscles in a manner which generates an anterior replacement leaflet and a posterior replacement leaflet, both of which span the distance between the anterior papillary muscle and the posterior papillary muscle, thereby causing the anterior
replacement leaflet and the posterior replacement leaflet to form a line of commissure during valve closure which closely
approaches the anterior papillary muscle tip and the posterior papillary muscle tip.

11. The method of Claim 8 wherein the intestinal tissue is secured to the valve annulus using an annuloplasty ring.

12. The method of Claim 8 wherein the intestinal tissue is extracted from the abdomen of the patient who receives the replacement heart valve.

13. The method of Claim 12 wherein the intestinal tissue is chemically treated to reduce thrombogenicity and calcification potential .

14. The method of Claim 8 wherein the intestinal tissue is extracted from a mammalian animal other than the patient, wherein the animal is selected from the group consisting of humans, non-human primates, and genetically-engineered hypoallergenic pigs.

15. A method of surgically creating an atrioventricular
replacement valve in a patient's heart, comprising the following steps:
a. creating a tubular segment of material having an inlet end, a thin and flexible wall portion having diametrically opposing sides, and an outlet end, and characterized by an absence of an artificially-created longitudinal seam;
b. surgically removing from the patient's heart an
atrioventricular valve which does not function properly, thereby generating an unoccupied valve annulus between an atrial chamber and a ventricular chamber, wherein removal of the
atrioventricular valve includes removal of native valve leaflets and at least some chordae tendinea while leaving at least some papillary muscles intact in the ventricular chamber;
c. circumferentially securing the inlet end of the tubular segment to the unoccupied valve annulus;
d. coupling selected portions of the outlet end of the tubular segment to papillary muscles in the ventricular chamber, in a manner which allows the collapsible wall portion of the tubular segment to be manipulated by fluid pressure so that the opposing sides of the tubular segment will open during diastole and approximate during systole, in a manner similar to leaflets in a natural atrioventricular valve wherein approximation of the tubular tissue segments creates a line of commissure which resembles native leaflet commissure, thereby preventing backflow of blood into the atrial chamber during systole without impeding flow through the replacement valve during diastole.

16. The method of Claim 15 wherein the tubular segment consists essentially of intestinal tissue.

17. The method of Claim 16 wherein the intestinal tissue has been extracted from the patient who is to receive the replacement valve.

18. The method of Claim 16 wherein the intestinal tissue has been extracted from a human or other species of animal and has been treated to reduce its antigenicity.

19. The method of Claim 15 wherein the tubular segment consists essentially of synthetic material.

20. The method of Claim 15 wherein the atrioventricular
replacement valve is created without utilizing a stent or annuloplasty ring, and wherein the tubular segment is sutured directly to the valve annulus.

21. The method of Claim 15 wherein the atrioventricular
replacement valve is created by utilizing an annuloplasty ring to provide a bridge between the valve annulus and the inlet end of the tubular tissue segment.

22. A method of surgically replacing a semilunar heart valve in a human patient in need thereof, comprising the following steps: a. extracting a segment of intestinal tissue from a mammalian abdomen; and,
b. using the intestinal tissue to form at least one component of the semilunar replacement valve for the patient's heart.

23. The method of Claim 22 wherein the intestinal tissue is used to replace a semilunar valve inside an arterial wall by the following steps:
a. securing a first inlet end of the intestinal tissue to a valve annulus from which native semilunar cusps have been
removed;
b. securing a second outlet end of the intestinal tissue to the artery at three spaced locations around the outlet end of the intestinal tissue in a manner which creates three unconstrained tissue regions between the three spaced locations at which the outlet end is secured, wherein the unconstrained tissue regions are capable of flexing inwardly to function as semilunar cusps;

c. closing the artery and restarting the heart.

24. The method of Claim 22 wherein the intestinal tissue is extracted from the abdomen of the patient who receives the replacement heart valve.

25. The method of Claim 22 wherein the intestinal tissue has been extracted from a human or other species of animal and has been treated to reduce its antigenicity.

26. A method of surgically creating a semilunar replacement valve in a heart of a patient in need thereof, comprising the following steps:
a. surgically opening a ventricular outflow artery at a location adjacent to a native semilunar valve having cusps which do not function properly;
b. removing the cusps from the native semilunar valve, thereby generating an unoccupied valve annulus between the artery and a ventricular chamber;
c. inserting into said artery a tubular segment having an inlet end, a thin and flexible wall portion having diametrically opposing sides, and an outlet end;
d. circumferentially securing the inlet end of the tubular tissue segment to the unoccupied valve annulus;
e. securing the tubular segment to the ventricular outflow artery at three spaced locations around the outlet end of the tubular tissue segment, in a manner which creates three
unconstrained regions between the three spaced locations at which the outlet end is secured, wherein the unconstrained regions are capable of flexing inwardly to function as semilunar cusps in the replacement valve;
f. closing the artery and restarting the heart.

27. The method of Claim 26 wherein the tubular segment consists essentially of intestinal tissue.

28. The method of Claim 27 wherein the intestinal tissue has been extracted from the patient who is to receive the replacement valve.

29. The method of Claim 27 wherein the intestinal tissue has been extracted from a human or other species of animal and has been treated to reduce its antigenicity.

30. The method of Claim 26 wherein the tubular segment consists essentially of synthetic material.

31. The method of Claim 26 wherein the semilunar replacement valve is created without utilizing a stent or annuloplasty ring, wherein the tubular segment is sutured directly to the valve annulus.

32. The method of Claim 26 wherein the atrioventricular
replacement valve is created by utilizing an annuloplasty ring to provide a bridge between the valve annulus and the inlet end of the tubular tissue segment.