Process for making porous membranes

• US 5,229,045 A
• Filed: 09/18/1991
• Issued: 07/20/1993
• Est. Priority Date: 09/18/1991
• Status: Expired due to Term

• Current Assignee: Kontron Instruments Holding, N.V.
• Original Assignee: Kontron Instruments, Inc.
• Inventors: Soldani, Giorgio
• Primary Examiner(s): Tentoni, Leo B.
• Application Number:
  US07/761,508
• Time in Patent Office: 671 Days
• Field of Search: 264/41, 264/45.7, 264/310, 264/330, 264/331.11, 264/331.19, 427/2, 427/245, 427/246
• US Class Current: 264/41
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08J 2201/0542 from an organic solvent-based polymer composition
• CPC Class Codes: C08J 9/28 by elimination of a liquid phase from a macromolecular composition or article, e.g. drying of coagulum
• CPC Class Codes: Y10S 623/921 Blood vessel

Abstract

Porous, distensible, gel-like membranes which in tubular form are suitable as implants, e.g., vascular prostheses and a process for the preparation thereof. The membranes are formed by a spraying, phase-inversion technique which employs thermodynamically unstable polymer solutions and is accomplished by separately spraying the unstable solution and a nonsolvent onto a rotating surface. Prostheses from the highly porous tubular membranes have shown a high degree of patency and completeness of the healing process and are useful for direct implantation in the body or for extracorporeal vascular accesses.

Claims

1. A process for the preparation of porous polymeric membranes comprising,

a) forming a solution of a polymer in a solvent for the polymer;

b) adding a nonsolvent to the polymer solution until a thermodynamically unstable polymer solution is obtained;

c) separately spraying the unstable polymer solution and nonsolvent from separate spray means onto a sliding and rotating mandrel means to form a precipitated material; and

d) placing the precipitated material into a bath of nonsolvent to cure the precipitated material.

2. Process according to claim 1, wherein the polymer is a polyamino-acid, a polysaccharide, a cellulose derivative, an alginate, a silicone, a polyurethane or mixtures thereof.

3. Process according to claim 1, wherein the polymer is elastomeric, biocompatible and blood compatible.

4. Process according to claim 1, wherein the solvent is water-miscible and has a low boiling point.

5. Process according to claim 4, wherein the solvent is tetrahydrofuran, an amide solvent, a sulfoxide solvent, a dioxane or mixtures thereof.

6. Process according to claim 1, wherein the nonsolvent is miscible with the solvent and has a solubility parameter different from the polymer.

7. Process according to claim 1, wherein the nonsolvent is water, an alcohol, or water containing a substance which enhances the inducement of solution instability and/or precipitation of polymer from the solution.

8. Process according to claim 7, wherein the solvent is water, a lower alkanol or mixtures thereof.

9. Process according to claim 1, wherein the polymer is polyurethane.

10. Process according to claim 1, wherein the polymer is a polyether urethane-poly(dialkylsiloxane).

11. Process according to claim 10, wherein the solvent is a mixture of tetrahydrofuran and 1, 4-dioxane.

12. Process according to claim 11, wherein the nonsolvent is water.

13. Process according to claim 12, wherein the polymer solution concentration (% w/v) is from about 0.1 to 5.0, the amount of nonsolvent added to the polymer is about 1 to 50 (%v/v), the spray means is driven under gas driving pressure of from about 1 to 45 psi, the polymer solution flow rate from the spray means is about 0.5 to 5.0 ml/min, the nonsolvent flow rate from the spray means is about 0.5 to 5.0 ml/min the angle between the separate spray means for the nonsolvent and polymer solution and the mandrel means is about 70°

to 80°

, the distance between nozzles of the separate spray means and the mandrel means of about 15 to 100 mm, the mandrel means diameter is from about 0.5 to 1000 mm, the speed of rotation of the mandrel means is about 100 to 2000 rpm and the sliding movement speed of the mandrel means is about 10 to 500 m/min.