Method of forming prosthetic devices

• US 4,670,286 A
• Filed: 12/26/1985
• Issued: 06/02/1987
• Est. Priority Date: 09/20/1983
• Status: Expired due to Term

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: Allied Corp. (Honeywell International Inc.)
• Inventors: Nyilas, Emery, Chiu, Tin-Ho
• Primary Examiner(s): Silverberg, Sam
• Application Number:
  US06/813,336
• Time in Patent Office: 523 Days
• Field of Search: 427/2, 427/430.1, 623/1
• US Class Current: 427/2.24
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A sterile shaped prosthetic device, suitable for insertion into a mammalian body, is at least partly composed of a bioresorbable material that is digestible by macrophages, its surface properties favor the attachment and adhesion of fibroblast cells capable of producing collagen for organized connective tissues, and the material itself or its degradation products can induce in vivo the formation of new capillary vessels (termed a "vasotropic" effect herein). Preferred prosthetic devices have through passages, the interspatial dimensions which are sufficient to permit several layers of mammalian cells to form within each passage. The invading fibroblast cells commence formation of collagen leading to connective tissue while macrophages and extracellular enzymes degrade the material, and newly formed capillary vessels penetrate the prosthesis and provide blood containing oxygen and nutrients which further the formation of organized tissue around as well as within the prosthetic device.

Claims

1. A method of forming a prosthetic fabric device at least a portion of which is of a bioresorbable material whose surface properties favor fibroblast cell attachment and adhesion, and also encourage the infiltration of macrophages comprising the steps of dipping said device at a controlled rate into a solution of a bioresorbable, vasotropic effect inducing material, partial drying and inverting said device and redipping said device in said solution to form a bioresorbable coating on said device.

2. The method of claim 1 wherein said device is a fabric of bioresorbable and nonbioresorbable yarns.

3. The method of claim 2 and including after said redipping the further steps of stretching said coated fabric and dipping said stretched fabric in a solution of bioresorbable, vasotropic effect inducing material to form a prosthetic fabric article that has a leak rate of less than about 100 cm^-2 min^-1.

4. The method of claim 1 wherein said bioresorbable, vasotropic effect inducing material is a polyester derived from a Krebs-Cycle dicarboxylic acid and a metabolizable diol.

5. The method of claim 4 wherein said polyester is selected from the class consisting of poly(D,L-lactic acid) and poly(2,3-butylene succinate).

6. The method of claim 2 wherein the bioresorbable yarns are present in an amount of at least about 15%.

7. The method of claim 2 wherein the bioresorbable yarns are present in an amount of about 65% to 80%.

8. The method of claim 5 wherein the bioresorbable, vasotropic effect inducing material is a synthetic polymer.

9. The method of claim 5 wherein the bioresorbable, vasotropic effect inducing material is poly (D,L-lactic acid).

10. A method of forming a tubular vascular fabric prothesis at least a portion of which is of a bioresorbable material whose surface properties favor fibroblast cell attachment and adhesion, and also encourage the infiltration of macrophages comprising the steps of dipping said device at a controlled rate into a solution of synthetic bioresorbable, vasotropic effect inducing material partial drying inverting said device and redipping said device in said solution to form a bioresorbable coating on said device.