Tubular polytetrafluoroethylene implantable prostheses

• US 5,716,660 A
• Filed: 05/31/1995
• Issued: 02/10/1998
• Est. Priority Date: 08/12/1994
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Meadox Medicals, Inc. (Boston Scientific Corporation)
• Inventors: Weadock, Kevin, Lentz, David J., Zdrahala, Richard J.
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/455,714
• Time in Patent Office: 986 Days
• Field of Search: 427/2.24, 427/2.25, 427/2.3, 427/2.31, 427/246, 427/338, 427/342, 427/389.9, 427/394, 427/414
• US Class Current: 427/2.25
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/22 Polypeptides or derivatives thereof , e.g. degradation products
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

An implantable prosthesis comprising an expanded polytetraethylene member having pores present in its wall structure wherein said pores contain a solid insoluble biocompatible, biodegradable material of natural origin. A process of preparing said prostheses is also disclosed.

Claims

1. A process of preparing an expanded polytetrafluoroethylene (e-PTFE) tubular prosthesis having a microporous wall structure including nodes, internodal spaces and fibrils interconnecting said nodes wherein said internodal spaces have been impregnated with a solid, insoluble biocompatible material, comprising the steps of:

preparing a dispersion or solution of a soluble biocompatible, biodegradable material including extracellular matrix proteins selected from the group consisting of collagen, gelatin, vitronectin, fibronectin, laminin, reconstituted basement membrane matrices and mixtures thereof at an acidic pH;

contacting said prosthesis with said dispersion or solution to impregnate said internodal spaces with said soluble biocompatible material;

increasing the pH of said dispersion or solution to precipitate out said soluble biocompatible, biodegradable material to render it into an insoluble state, whereby said internodal spaces are substantially filled with said insoluble biocompatible, biodegradable material.

2. A process of claim 1 whereby said precipitating out is achieved by treatment with a buffered phosphate solution to form said solid insoluble biocompatible, biodegradable material.

3. A process of claim 2 wherein said solid insoluble biocompatible, biodegradable material is cross-linked by exposure to an aldehyde vapor.

4. A process of claim 1 whereby said e-PTFE structure is rendered hydrophilic by immersion in a solution of water-soluble polymers.

5. The process of claim 4 wherein said water-soluble polymer is an oxygen-containing hydrocarbon selected from the group consisting of polyvinylalcohol, polyethylene oxide, polyethylene glycol, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose.

6. A process of claim 4 wherein said water-soluble polymer is a nitrogen-containing polymer selected from the group consisting of polyacrylamide, polyvinyl pyrrolidone, polyvinylamine and polyethyleneimine.

7. A processes of claim 1 further comprising a step of rinsing said prosthesis in a sterilizing solution.

8. A process of claim 7 wherein said step of rinsing includes treating with an ethylene oxide solution.