Stentless bioprosthetic heart valve with coronary protuberances and related methods for surgical repair of defective heart valves

• US 6,001,126 A
• Filed: 12/24/1997
• Issued: 12/14/1999
• Est. Priority Date: 12/24/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Nguyen-Thien-Nhon, Diana
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/998,318
• Time in Patent Office: 720 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.11
• 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:

tissue harvested from a mammalian donor animal, said tissue including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough and right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens; and

,

a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and

ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment,

wherein the bioprosthesis has been subjected to a chemical fixation process comprising placing support members into the coronary lumens during the chemical fixation process.

2. The bioprosthesis of claim 1 wherein said support members comprise mandrel members which ire inserted into the coronary lumens to maintain patency of said coronary lumens during said chemical fixation process.

3. The bioprosthesis of claim 2 wherein the mandrel members are formed of material selected from the group of materials consisting of:

silicone;

polyurethane;

polyester;

polytetrafluoroethylene;

polyethylene;

stainless steel;

titanium; and

,

a metal alloy.

4. The bioprosthesis of claim 2 wherein said mandrel members have bores extending longitudinally therethrough.

5. The bioprosthesis of claim 2 further comprising;

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

6. The bioprosthesis of claim 5 wherein said mandrel retaining apparatus are selected from the group of mandrel retaining apparatus consisting of:

a. ligatures placed about said coronary artery segments; and

,

b. clamps placed upon said coronary artery segments.

7. The bioprosthesis of claim 5 wherein any portion of said coronary artery segments which has been deformed by said mandrel retaining apparatus is cut away after chemical fixation of the bioprosthesis.

8. The bioprosthesis of claim 7 wherein after any portion of said coronary artery segments which have been deformed by said mandrel retaining apparatus have been cut away, the remaining coronary artery segments are at least 2 mm in length.

9. The bioprosthesis of claim 7 wherein after any portion of said coronary artery segments which have been deformed by said 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 said coronary artery segments are at least 2 mm in length at the time of surgical implantation of the bioprosthesis.

11. The bioprosthesis of claim 1 wherein said tissue is of porcine origin.

12. The bioprosthesis of claim 1 wherein said tissue comprises connective tissue proteins which have been crosslinked by 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.

13. The bioprosthesis of claim 1 further comprising:

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

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

15. A system for implanting a bioprosthetic heart valve, comprising:

a valve retainer fixture attached to the bioprosthcsis of claim 1, said valve retainer fixture being configured to facilitate the attachment of an elongate handle thereto to facilitate holding of the bioprosthesis during surgical implantation.

16. The bioprosthesis of claim 1 wherein the valve leaflets disposed within the aortic segment lumen are attached at points to the interior of the aortic segment wall generally at the inflow end, the bioprosthesis further including a marker thread provided on the interior of the aortic segment wall between the points of attachment of the valve leaflets and coronary segments to facilitate trimming of said bioprosthesis to separate the aortic segment with the valve leaflets from the aortic segment with the coronary segments.

17. A method for total root replacement of an endogenous aortic heart valve in a mammalian patient, said method comprising the steps of:

A. providing an aortic bioprosthcsis which comprises;

i) an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough;

ii) right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary segment lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary segment lumens; and

,

iii) a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between a) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and

b) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment;

B. 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;

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

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

,

E. anastomosing the patient'"'"'s coronary arteries to the coronary segments of the bioprosthesis, at spaced distances from the wall of the aortic segment of the bioprosthesis.

18. The method of claim 17 wherein the coronary segments of the bioprosthesis provided in Step A are at least 2 mm in length, and wherein the anastomoses of the patient'"'"'s coronary arteries to the coronary segments of the bioprosthesis performed in step E are located at least 2 mm from the wall of the aortic segment of the bioprosthesis.

19. A tanning kit for manufacturing an implantable stentless heart valve bioprosthesis comprising:

a heart valve harvested from a mammalian donor animal, said heart valve including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough, right and left coronary artery segments extending outwardly from said aortic segment, and a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and

ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment; and

support members configured to closely fit within the coronary lumens during tanning so that after tanning said coronary artery segments have open coronary lumens which extend longitudinally therethrough, and blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens.

20. The kit of claim 19 wherein said coronary artery segments are at least 2 mm in length.

21. The kit of claim 19 wherein said support members comprise mandrel members formed of material selected from the group of materials consisting of:

silicone;

polyurethane;

polyester;

polytetrafluoroethylene;

polyethylene;

stainless steel;

titanium; and

,

a metal alloy.

22. The kit of claim 21 wherein said mandrel members have bores extending longitudinally therethrough.

23. The kit of claim 21 further comprising;

mandrel retaining apparatus placed upon said coronary artery segments to hold said mandrel members within said coronary lumens, each of said mandrel retaining apparatus being removable following tanning.

24. The kit of claim 23 wherein said mandrel retaining apparatus are selected from the group of mandrel retaining apparatus consisting of:

ligatures placed about said coronary artery segments; and

,

clamps placed upon said coronary artery segments.

25. A stentless heart valve bioprosthesis comprising:

tissue harvested from a mammalian donor animal, said tissue including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough and right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens, wherein said tissue comprises connective tissue proteins which have been crosslinked by 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; and

,

a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and

ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment.

26. The bioprosthesis of claim 25 wherein said coronary artery segments are at least 2 mm in length at the time of surgical implantation of the bioprosthesis.

27. The bioprosthesis of claim 26 wherein said coronary artery segments are 2-6 mm in length.