Method of making an artificial heart valve stent

• US 5,469,868 A
• Filed: 08/04/1994
• Issued: 11/28/1995
• Est. Priority Date: 02/12/1992
• Status: Expired due to Fees

• Current Assignee: Reger Medical Incorporated
• Original Assignee: Reger Medical Incorporated
• Inventors: Reger, Vincent A.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/286,162
• Time in Patent Office: 481 Days
• Field of Search: 623/2, 623/11, 623/66, 623/901, 623/12, 128/898, 112/262.1, 29/890.12, 29/890.124, 29/890.126, 29/890, 29/128, 29/890.132
• US Class Current: 128/898
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A novel, long lasting prosthetic heart valve compatible with implantation in a human natural heart valve annulus. The prosthetic heart valve comprises a trileaflet heart valve apparatus which in form, dimension, and function resembles a human trileaflet heart valve, but which is formed of synthetic resinous material. A seamless supporting frame capable of annular deformation and limited perimetric expansion during each heartbeat is totally enveloped in an essentially biologically inert cylindrical cover to form a cusp supporting stent for the valve leaflet apparatus. The free top and bottom edges of the cylindrical cover are disposed on the exterior of the stent and everted outward to provide at least one sewing ring. Valve embodiments comprise aortic and mitral implantable valves. For the aortic implant, the outwardly everting free sewing ring forming edges are separated by circumferentially disposed compressible and expandable material which provides a pliable, compliant interface between the valve and the natural valve annulus at the implanting site. In one embodiment, the synthetic trileaflet heart valve apparatus is formed by a unicast mold. In another embodiment, the heart valve apparatus is formed from a cylinder of synthetic resinous material. Valve sewing ring covers can be selectively impregnated with antibiotic medicants to substantially eliminate early post implant infection. Use of non-thrombogenic biochemically inert materials in a valve apparatus which mimics operation of a natural heart valve essentially eliminates the need for long term administration of anticoagulants.

Claims

1. A method for making a stent for a prosthetic heart valve comprising the steps of:

forming a hollow cylindrical frame comprising raised stanchions and a base for support of a leaflet heart valve;

inserting cylindrically shaped covering into the interior of the hollow cylindrical frame such that each end of the covering extends beyond the stanchions and base of the cylindrical frame;

folding the covering about the cylindrical frame, thereby substantially enveloping the cylindrical frame;

outwardly everting each end of the covering to form at least two sewing rings;

trimming the covering which is disposed between the stanchions such that a pocket is formed about each stanchion;

sewing the trimmed covering to totally enclose each stanchion;

sewing each sewing ring along the line of outward eversion to the cylindrical framed and inserted portion of the covering.

2. The method according to claim 1 wherein the outwardly everting step comprises:

disposing and affixing between said at least two sewing rings a perimetrically variable compliant interfacing portion of soft material.

3. The method according to claim 1 comprising the further step of covering at least one sewing ring with material having tissue ingrowth capability.