Rapid assembly, concentric mating stent, tissue heart valve with enhanced clamping and tissue alignment

• US 5,163,955 A
• Filed: 01/24/1991
• Issued: 11/17/1992
• Est. Priority Date: 01/24/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics Co.
• Inventors: Love, Jack W., Love, Charles S., Calvin, John H.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Willse, D.
• Application Number:
  US07/646,001
• Time in Patent Office: 663 Days
• Field of Search: 623/2, 623/900, 623/66, 623/901, 137/515.7, 251/365
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10S 623/913 Heart
• CPC Class Codes: Y10S 623/918 Heart
• CPC Class Codes: Y10T 137/7857 Valve seat clamped between coupling elements
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Claims

1. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon and not engaging the other of said first and second stents;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding of said tissue alignment members, the holes and alignment numbers being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size; and

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents.

2. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon, all the tissue alignment members configured on said stent having a body portion and a securing portion, with the securing portion permanently affixed to and extending radially outward from the body portion on each;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size; and

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents.

3. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size; and

tensioning means adapted to induce the first and second stents to clamp said piece of tissue between said stents and securely hold it in place between said stents;

wherein said stents and said tensioning means are configured to avoid creation of a significant number of mechanical fixation points where stress can concentrate in the assembled valve.

4. A heart valve, comprising:

a first stent, and a second stent, when one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that such tissue, when registered with said members, forms valve leaflets of approximately uniform size; and

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents;

wherein said stents and said tensioning means are configured such that all portions of said tissue situated between said stents are securely held in place between said stents by clamping without significant reliance on said tissue alignment members, such that said tissue alignment members do not play a significant role in securely holding any portion of the tissue in place between said stents in the assembled valve.

5. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents has a base and a plurality of posts extending therefrom and spaced around the base, with said one stent being configured with a plurality of tissue alignment members, and with all the tissue alignment members configured on said stent extending from a surface of said posts;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size, said tissue having a thickness; and

self-adjusting tensioning means adapted to induce the first and second stents to clamp said tissue between said stents, while adjusting for variations in the thickness of said tissue, and securely hold it in place between said stents.

6. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending along a first path from a surface thereon, at least one of said members comprising a body portion and a head portion, said head portion extending at least partly outward along a second path different from said first path from a surface of said body portion;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, wherein said head portion of said at least one tissue alignment member prevents substantial slippage of said tissue during valve assembly, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size; and

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents.

7. The heart valve of claim 6 wherein said head portion of said at least one tissue alignment member is mushroom-shaped.

8. The heart valve of claim 6 wherein said head portion of said at least one tissue alignment member is hook-shaped.

9. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size;

wherein each of said first and second stents has a base with a plurality of spaced posts extending therefrom along an axis of the valve, with the posts of one stent adapted to be capable of extending at least partly into corresponding indentations in the posts of the other stent but which are prevented from doing so completely by said tissue situated between said stents, such that at least a portion of said tissue is clamped by and between said posts; and

tensioning means adapted to induce the first and second stents to further clamp said tissue between said stents and securely hold it in place between said stents.

10. The valve of claim 9 wherein said indentations are formed with cloth-covered windows in the posts of said other stents.

11. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size;

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents; and

wherein each of said first and second stents has a base with a plurality of spaced posts extending therefrom along an axis of the valve, with the posts of one stent adapted to normally extend at least partly towards the posts of the other stent independently of said tensioning means but which are prevented from doing so completely by said tissue situated between said stents, such that at least a portion of said tissue is clamped by and between said posts.

12. A heart valve, comprising:

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon;

at least one piece of autogenous tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size; and

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents.

13. The valve of claim 12 wherein said at least one piece of autogenous tissue is freshly harvested.

14. The valve of claim 12 wherein said at least one piece of tissue is chemically treated.

15. A heart valve, comprising;

a first stent, and a second stent, wherein one of said first and second stents is configured with a plurality of tissue alignment members extending from a surface thereon;

at least one piece of tissue situated between said first and second stents and having a plurality of holes registered with corresponding ones of said tissue alignment members, the holes and alignment members being configured such that said tissue, when registered with said members, forms valve leaflets of approximately uniform size;

tensioning means adapted to induce the first and second stents to clamp said tissue between said stents and securely hold it in place between said stents;

a sewing ring; and

a covering for integrating the sewing ring with one of said first and second stents by covering and forming a closed surface over both.

16. The valve of claim 15 wherein said tensioning means is integrated with said sewing ring and said one of said first and second stents by covering and forming a closed surface over the same with said covering.

17. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of said one stent, and not engaging the other of said first and second stents after formation of the members;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

18. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of said one stent;

configuring all the tissue alignment members configured on said one stent to have a body portion and a corresponding securing portion;

permanently affixing the securing portion of all of said tissue alignment members configured on said one stent to the corresponding body portion;

extending the securing portions of said tissue alignment members radially outward from the corresponding body portions;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

19. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of said one stent;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members;

inducing the first and second stents to securely hold said tissue between said stents by clamping while avoiding creating a significant number of mechanical fixation points where stress can concentrate in the assembled valve.

20. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of said one stent;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to securely hold all portions of said tissue in place between said stents by clamping without significant reliance on said tissue alignment members to securely hold any portion of said tissue in place between said stents.

21. A method of assembling a heart valve comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a base and a plurality of posts extending thereform and spaced around the base;

configuring said one stent with a plurality of tissue alignment members;

extending all of the tissue alignment members configured on said one stent from a surface of said posts of said one stent;

configuring at least one piece of tissue with a plurality of holes, the tissue having a thickness;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and generating a clamping force sufficient to securely hold it in place while adjusting the clamping force for variations in the thickness of the tissue.

22. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members along a first path from a surface of said one stent;

configuring at least one of said tissue alignment members to have a body portion nd a corresponding head portion integral with and affixed to the body portion;

extending the head portion of said at least one member at least partly outward along a second path different from said first path from a surface of said corresponding body portion;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

23. The method of claim 22 further comprising configuring said head portion of said at least one tissue alignment member to be hook-shaped.

24. A method of assembling a heart valve, comprising;

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members along a first path from a surface of said one stent;

configuring at least one of said tissue alignment members to have a body portion and a corresponding head portion;

extending the head portion of said at least one member at least partly outward along a second path different from said first path from a surface of said corresponding body portion including configuring said head portion of said at least one tissue alignment member to be mushroom-shaped;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

25. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of one of said first and second stents;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members;

configuring each of said first and second stents with a base and a plurality of spaced posts extending therefrom along an axis of the valve;

adapting the posts of one of said stents to be capable of extending at least partly into corresponding indentations in the posts of the other stent; and

situating said tissue between said stents, thereby preventing said posts of said one stent from fully extending at least partly into said corresponding indentations in the posts of the other stent and clamping at least a portion of said tissue by and between said posts.

26. The method of claim 25 further comprising forming said indentations with cloth-covered windows in the posts of said other stent.

27. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending said tissue alignment members from a surface of one of said first and second stents;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members;

configuring each of said first and second stents with a base and a plurality of spaced posts extending therefrom along an axis of the valve;

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place;

adapting the posts of one of said stents to normally extend at least partly towards corresponding posts of the other stent independently of said inducing step; and

situating said tissue between said stents, thereby preventing said posts of said one stent from fully extending at least partly towards said corresponding posts of the other stent and clamping at least a portion of said tissue by and between said posts.

28. A method of assembling a heart valve, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of one of said first and second stents;

configuring at least one piece of autogenous tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

29. The method of claim 28 further comprising freshly harvesting said at least one piece of autogenous tissue.

30. The method of claim 28 further comprising chemically treating said at least one piece of autogenous tissue.

31. A method of assembling a heart valve for use in a valve replacement operation, comprising:

providing a first stent and a second stent;

configuring one of said first and second stents with a plurality of tissue alignment members;

extending the tissue alignment members from a surface of one of said first and second stents;

integrating a sewing ring with one of said first and second stents prior to when the same is needed in the valve replacement operation;

configuring at least one piece of tissue with a plurality of holes;

registering said holes with corresponding ones of said tissue alignment members; and

inducing the first and second stents to clamp said tissue between said stents and securely hold it in place.

32. The method of claim 31 further comprising integrating a tensioning means with one of said first and second stents prior to when the same is needed in said valve replacement operation.