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

• US 5,489,298 A
• Filed: 03/07/1995
• Issued: 02/06/1996
• 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.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/400,466
• Time in Patent Office: 336 Days
• Field of Search: 623/2, 623/66, 623/900, 623/901, 137/515.7, 251/365
• US Class Current: 623/2.14
• 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 2/2472 Devices for testing
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. The valve comprises at least one piece of tissue clamped between an inner and an outer stent. The outer stent is configured with a plurality of spaced posts extending from a base, wherein the posts are configured with open windows so that at least a portion of the tissue in the assembled valve is exposed through the windows. Several embodiments of the outer stent are disclosed, including where the outer stent comprises a crimped metal wire frame covered with a Dacron tube.

Claims

1. A heart valve comprising:

a first stent and a second stent, said second stent having a continuous periphery and a tangent plane associated with every point along said periphery, wherein said second stent comprises a cloth-covered metal wire frame crimped at a plurality of locations along said periphery of said second stent, thereby providing said second stent with a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stents, said pressure inducing fixation points of said one stent being oriented to induce pressure on said tissue; 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.

2. The valve of claim 1 wherein said second stent crimped metal wire frame is crimped at said plurality of locations in a direction perpendicular to said tangent plane at said points on said periphery of said second stent.

3. A method of assembling a heart valve comprising:

providing a first stent and a second stent, said second stent having a periphery and a tangent plane associated with every point along said periphery;

configuring said second stent to be a cloth-covered metal wire frame crimped at a plurality of locations along said periphery of said second stent, thereby configuring said second stent with a plurality of pressure-inducing fixation points;

situating at least one piece of tissue between said first and second stents;

orienting said pressure inducing points of said one stent to induce pressure on said tissue; and

inducing the first and second stents to clamp said piece of tissue between said stents.

4. A heart valve comprising:

a first stent and a second stent;

at least one piece of tissue situated between said first and second stents;

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 of said stents 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

a metal clip emplaced in said second stent, said metal clip having flanges on one end and an ear portion on the other end, said flanges bent upward to lock said ear portion into place when said valve is assembled, said clip thereby providing a permanent, reliable and controllable clamping force on said second stent to thereby induce the first and second stents to further clamp said piece of tissue between said stents and securely hold it in place between said stents.

5. A heart valve comprising:

a first stent and a second stent, wherein one of said stents comprises a cloth-covered beaded metal wire frame, said beaded frame providing a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stents, said pressure inducing points of said one stent being oriented to induce pressure on said tissue; 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.

6. A heart valve comprising:

a first stent and a second stent, wherein one of said stents comprises a cloth-covered coiled metal wire frame, said metal wire frame having a plurality of coils, said coils providing a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stents, said pressure inducing points of said one stent being oriented to induce pressure on said tissue; 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.

7. A heart valve comprising:

a first stent and a second stent, said second stent having a continuous periphery and a tangent plane associated with every point along said periphery, wherein said second stent comprises a cloth-covered metal wire frame crimped at a plurality of locations in a direction perpendicular to said tangent plane at said points on said periphery of said second stent, thereby providing said second stent with a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stents, said pressure-inducing fixation points of said one stent being oriented to induce pressure on said tissue; and

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

8. A heart valve comprising:

a first stent having a continuous periphery and a second stent having a continuous periphery, said second stent having a tangent plane associated with every point along said periphery of said second stent, wherein said second stent comprises a cloth-covered metal wire frame crimped at a plurality of locations along said periphery of said second stent, thereby providing said second stent with a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stent, said pressure-inducing fixation points of said one stent being oriented to induce pressure on said tissue; and

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

9. A heart valve comprising:

a first stent and a second stent, said second stent having a continuous periphery and a tangent plane associated with every point along said periphery, wherein said second stent comprises a cloth-covered metal wire frame crimped at a plurality of locations along said periphery of said second stent, thereby providing said second stent with a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stents, said pressure inducing fixation points of said one stent being oriented to induce pressure on said tissue; 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 tensioning means lies substantially in a common plane.

10. A heart valve comprising:

a first stent and a second stent, said second stent having a continuous periphery and a tangent plane associated with every point along said periphery, wherein said second stent comprises a cloth-covered metal wire frame crimped radially inwardly at a plurality of locations along said periphery of said second stent, thereby providing said second stent with a plurality of pressure-inducing fixation points;

at least one piece of tissue situated between said first and second stents, said pressure-inducing fixation points of said one stent being oriented to induce pressure on said tissue; and

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