Method of manufacture of enhanced surface implant

• US 5,525,275 A
• Filed: 07/27/1993
• Issued: 06/11/1996
• Est. Priority Date: 07/27/1993
• Status: Expired due to Term

• Current Assignee: PMT Corporation
• Original Assignee: PMT Corporation
• Inventors: Costello, David M., Keeter, Timothy A., Broome, Thomas E., Iversen, Alfred A.
• Primary Examiner(s): Vargot, Mathieu D.
• Application Number:
  US08/097,564
• Time in Patent Office: 1,050 Days
• Field of Search: 128/DIG. 21, 623/7, 623/8, 623/11, 623/901, 264/131, 264/308, 264/28
• US Class Current: 264/28
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

An implantable body including an outer membrane forming an enclosure for receiving a filler material. The surface of the outer membrane is characterized by a random distribution of peaks separated by valleys. The peaks and valleys are separated by gradual contoured slopes with a smooth transition between the peaks and valleys which are substantially free from indentation. The enhanced surface provides improved anchoring of the implant, yet reduces host reaction. The enhanced surface is formed by depositing a distribution of cured polymeric particles on an uncured tacky surface. This intermediate surface is then cured, followed by application of a layer of uncured elastomeric material. The entire surface is then cured to form the enhanced surface.

Claims

1. A method for manufacturing an enhanced, random sculptured, irregular, substantially smooth surface of smoothly transitioned peaks, valleys, slopes and terraces without interstices on an elastomeric material suitable for use in an implant, comprising the steps of:

(a) providing an elastomeric material suitable for use as an implant, having a tacky surface;

(b) depositing a random distribution of cured polymeric particles on said tacky surface to form an intermediate textured surface;

(c) removing excess of said polymeric particles from said tacky surface;

(d) curing said intermediate textured surface;

(e) applying a layer of uncured elastomeric material over said intermediate textured surface; and

(f) curing said applied layer of uncured elastomeric material on said intermediate textured surface to form said enhanced, random sculptured surface.

2. The method of claim 1, wherein said elastomeric material having a tacky surface is uncured silicone rubber dispersed in a solvent.

3. The method of claim 2, wherein said polymeric particles are cryogenically ground silicone rubber particles.

4. The method of claim 3, wherein said polymeric particles have an average diameter that is less than 0.100".

5. The method of claim 1, wherein the uncured elastomeric material of step (e) is silicone rubber dispersed in a solvent.

6. The method of claim 1, wherein said step of curing said intermediate textured surface includes heating to a temperature between 130°

F. and 270°

F. for one hour.

7. The method of claim 6, wherein said step of curing said applied layer of uncured elastomeric material includes heating to a temperature between 130°

F. and 270°

F. for one hour.

8. A method for manufacturing an enhanced, random sculptured, irregular, substantially smooth surface of smoothly transitioned peaks, valleys, slopes and terraces without interstices on an elastomeric material suitable for use in an implant, comprising the steps of:

(a) providing an elastomeric material suitable for use as an implant, having a tacky surface;

(b) cryogenically grinding a cured polymeric material to produce cured polymeric particles;

(c) filtering said cured polymeric particles to a specific sieve size;

(d) depositing a random distribution of said cured polymeric particles on said tacky surface to form an intermediate textured surface;

(e) curing said intermediate textured surface;

(f) applying a layer of uncured elastomeric material over said intermediate textured surface; and

(g) curing said applied layer of uncured elastomeric material on said intermediate textured surface to form said enhanced, random sculptured surface.

9. The method of claim 8, wherein said polymeric particles have an average diameter that is less than 0.100".