Stentless bioprosthetic heart valve with patent coronary protuberances and method of surgical use thereof

• US 6,342,070 B1
• Filed: 12/14/1999
• Issued: 01/29/2002
• Est. Priority Date: 12/24/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nguyen-Thien-Nhon, Diana
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/461,304
• Time in Patent Office: 777 Days
• Field of Search: 623/2.1, 623/2-2-, 623/1.24, 623/1.26
• US Class Current: 623/2.15
• 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 2250/0097 Visible markings, e.g. indicia

Abstract

A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient'"'"'s native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a “button” or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

Claims

1. A stentless heart valve bioprosthesis comprising:

a fully implantable segment of mammalian aorta having an aortic lumen extending longitudinally therethrough, an inflow end, an outflow end, a plurality of aortic valve leaflets disposed within the aortic lumen, right and left coronary sinuses, a non-coronary sinus which is situated adjacent to and between the coronary sinuses, and right and left coronary artery segments having coronary artery segment lumens extending therethrough, the coronary artery segments extending outwardly from the coronary sinuses, the segment of mammalian aorta having been chemically fixed in such a way that the right and left coronary artery segments have a length of at least 2 mm and define patent lumens therethrough, wherein the coronary artery segments may be anastomosed to the native coronary arteries such that some of the blood which enters the lumen of the aortic segment may flow outwardly through the coronary lumens.

2. The bioprosthesis of claim 1 wherein the bioprosthesis has been formed in a fixing process using support members to maintain patency of the coronary lumens during the fixing process.

3. The bioprosthesis of claim 2 wherein the support members comprise mandrel members which are inserted into the coronary lumens to maintain patency of the coronary lumens during the fixing process.

4. The bioprosthesis of claim 3 wherein the mandrel members are formed of material selected from the group of materials consisting of:

(a) silicone;

(b) polyurethane;

(c) polyester;

(d) polytetrafluoroethylene;

(e) polyethylene;

(f) stainless steel;

(g) titanium; and

,

(h) a metal alloy.

5. The bioprosthesis of claim 3 wherein the mandrel members have bores extending longitudinally therethrough.

6. The bioprosthesis of claim 3 further comprising;

mandrel retaining apparatus placed upon the coronary artery segments to hold the mandrel members within the coronary lumens, the mandrel retaining apparatus being removable following fixing of the bioprosthesis.

7. The bioprosthesis of claim 6 wherein the mandrel retaining apparatus are selected from the group of mandrel retaining apparatus consisting of:

ligatures placed about the coronary artery segments; and

,

clamps placed upon the coronary artery segments.

8. The bioprosthesis of claim 6 wherein any portion of the coronary artery segments which may have been deformed by the mandrel retaining apparatus is cut away after fixing of the bioprosthesis.

9. The bioprosthesis of claim 8 wherein after any portion of the coronary artery segments which have been deformed by the mandrel retaining apparatus have been cut away, the remaining coronary artery segments are 2-6 mm in length.

10. The bioprosthesis of claim 1 wherein the segment of mammalian aorta is of porcine origin.

11. The bioprosthesis of claim 1 wherein the segment of mammalian aorta has been formed in a chemical fixing process using at least one fixative agent selected from the group of fixative agents consisting of:

an aldehyde;

glutaraldehyde;

formaldehyde;

a polyepoxy compound;

dialdehyde starch;

hexamethylene diisocyanate; and

combinations thereof.

12. The bioprosthesis of claim 1 further comprising:

a fabric reinforcement formed on at least a portion of the bioprosthesis to enhance its strength.

13. The bioprosthesis of claim 12 wherein the reinforcement fabric is formed about the inflow end of the bioprosthesis.

14. The bioprosthesis of claim 1 further comprising:

marker thread visible on the exterior of the segment of mammalian aorta to act as a guide in separating a portion of the bioprosthesis having the leaflets disposed therein from the remainder of the aorta and coronary artery segments.

15. A method of surgical replacement of a heart valve with a bioprosthesis as claimed in claim 1, comprising:

surgically transecting the patient'"'"'s right and left coronary arteries at locations which are spaced distances away from the wall of the patient'"'"'s ascending aorta;

surgically removing a segment of the patient'"'"'s ascending aorta, along with at least the leaflets of the endogenous aortic valve;

anastomosing the bioprosthesis to the patient'"'"'s native tissues such that the segment of mammalian aorta replaces the removed segment of the ascending aorta; and

,

anastomosing at least one of the patient'"'"'s coronary arteries to the corresponding coronary artery segment of the bioprosthesis at a spaced distance from the segment of mammalian aorta.

16. The method of claim 15 wherein the anastomosis of the patient'"'"'s coronary artery to the coronary artery segment of the bioprosthesis is located between about 2-6 mm from the segment of mammalian aorta.

17. The method of claim 15 including anastomosing both of the patient'"'"'s coronary arteries to the coronary artery segments of the bioprosthesis at spaced distances from the segment of mammalian aorta.

18. A method of surgical replacement of a heart valve with a bioprosthesis comprising:

providing a stentless heart valve bioprosthesis comprising a segment of mammalian aorta having an aortic lumen extending longitudinally therethrough, an inflow end, an outflow end, a plurality of aortic valve leaflets disposed within the aortic lumen, right and left coronary sinuses, a non-coronary sinus which is situated adjacent to and between the coronary sinuses, and right and left coronary artery segments having coronary artery segment lumens extending therethrough, the coronary artery segments extending outwardly from the coronary sinuses, the segment of mammalian aorta having been fixed with the right and left coronary artery segments defining patent lumens such that some of the blood which enters the lumen of the aortic segment may flow outwardly through the coronary lumens;

surgically removing the patient'"'"'s heart valve and a quantity of vascular tissue adjacent to the heart valve;

closing at least one of the patent lumens of the coronary artery segments of the bioprosthesis such that blood which flows through the lumen of the bioprosthesis will not flow out of the closed coronary artery segment; and

anastomosing the bioprosthesis to the patient'"'"'s native tissues such that the aortic bioprosthesis replaces the removed heart valve and adjacent vascular tissue.

19. The method of claim 18 closing both of the patent lumens of the coronary artery segments of the bioprosthesis such that blood which flows through the lumen of the bioprosthesis will not flow out of the closed coronary artery segments.

20. The method of claim 18 wherein the step of closing the patent lumen of the coronary artery segment of the bioprosthesis includes ligating the coronary artery segment.