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

• US 5,423,887 A
• Filed: 08/03/1992
• Issued: 06/13/1995
• 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, DAVID H
• Application Number:
  US07/925,380
• Time in Patent Office: 1,044 Days
• Field of Search: 623/2, 623/900, 623/66, 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 2/2418 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 concentric mating stent tissue heart valve, comprising:

an inner stent comprising an inner stent frame covered with a fabric, the inner stent frame having an annular base and three posts extending from the base along an axis of the valve, said posts being approximately equally spaced around the base, and connected by a scalloped edge, and each of said posts having a plurality of outward extending tissue alignment members which are not registered with holes in an outer stent, wherein the tissue alignment members extend through the fabric covering the inner stent frame;

at least one piece of tissue wrapped around the inner stent, and having a plurality of holes registered with the tissue alignment members of the inner stent, wherein the holes are configured to form three approximately uniformly sized valve leaflets from said piece of tissue, said piece of tissue having a first portion situated behind the posts of the inner stent and along the scalloped edge, and having a second portion situated along the annular base of the inner stent;

said outer stent configured to be concentric with the inner stent, with said piece of tissue secured between the stents primarily by clamping, comprising an outer stent frame, a garter spring, an elastomeric collar, and a fabric cover;

wherein the outer stent frame has an annular base and three posts extending from the base along the axis of the valve, said posts being approximately equally spaced around the base and connected by a scalloped edge, each of said posts configured for alignment with a corresponding one of said inner stent posts, and each of said outer stent posts having a window adapted for nesting with the inner stent post corresponding to said outer stent post, each outer stent post also having a window extension which extends through the annular base below each window, which window extensions are configured so that the outer stent frame is capable of being spread open at the annular base, wherein the annular base has a circular groove around its periphery, adapted for placement of the garter spring thereon;

wherein the garter spring is placed in the circular groove, and the elastomeric collar is placed around the garter spring to form an integrated assembly which is covered by the fabric to form the outer stent;

wherein the outer stent posts, adapted for nesting with corresponding inner stent posts, exert a first substantially self-adjusting clamping force on the first portion of the tissue situated between said stent posts, and the annular base of the outer stent, configured with said window extensions and said circular groove into which is placed said garter spring, in conjunction with the annular base of the inner stent, exerts a second substantially self-adjusting clamping force on the second portion of the tissue secured between said annular base.

2. A concentric mating stent tissue heart valve, comprising:

an inner stent comprising an inner stent frame covered with a fabric, the inner stent frame having an annular base and three posts extending from the base along an axis of the valve, said posts being approximately equally spaced around the base, and connected by a scalloped edge, and each of said posts having a plurality of outward extending tissue alignment members which are not registered with holes in an outer stent;

at least one piece of tissue wrapped around the inner stent, and having a plurality of holes registered with the tissue alignment members of the inner stent, wherein the holes are configured to form three approximately uniformly sized valve leaflets from said piece of tissue;

said outer stent configured to be concentric with the inner stent, with said piece of tissue secured between the stents primarily by clamping, comprising an outer stent frame, a garter spring, an elastomeric collar, and a fabric cover;

wherein the outer stent frame has an extendible annular base and three posts extending from the base along the axis of the valve, said posts being approximately equally spaced around the base and connected by a scalloped edge, each of said posts configured for alignment with a corresponding one of said inner stent posts, and each of said outer stent posts having a window adapted for nesting with the inner stent post corresponding to said outer stent post, each outer stent post also having a window extension which extends through the annular base below each window, which window extensions are configured so that the outer stent frame is capable of being spread open at the annular base, wherein the annular base has a circular groove around its periphery, adapted for placement of the garter spring thereon;

wherein said garter spring is placed in the circular groove, and the elastomeric collar is placed around the garter spring to form an integrated assembly which is covered by the fabric to form the outer stent;

wherein the outer stent exerts a self-adjusting clamping force on the tissue situated between said inner and outer stents.

3. A concentric mating stent tissue heart valve, comprising:

an inner stent comprising a frame with a fabric covering and tissue alignment members, wherein said tissue alignment members are not mechanically fixed with holes in an outer stent;

said outer stent comprising a frame and a fabric covering wherein said frame is superposable upon said inner stent;

a piece of tissue congruent in shape to said inner stent and configured with a plurality of holes which register with said inner stent'"'"'s tissue alignment members;

wherein said outer stent mates with said inner stent thereby clamping said piece of tissue securely between said stents, wherein said outer stent frame is configured with an annular base and three posts extending from and orthogonal to the plane containing said annular base, said posts being equally spaced from one another and having scalloped edges connecting said posts, wherein each of said outer stent posts has a window adapted for nesting with each of corresponding inner stent posts, said window having an extension which extends through the annular base and configured so that the outer stent frame is capable of being spread open at the annular base, and

wherein said outer stent further comprises a garter spring and an elastomeric collar, wherein said garter spring is placed in a groove of said annular base of said outer stent and said elastomeric collar is placed over said garter spring, thereby forming an integrated assembly which is covered by said fabric to form the outer stent.