Method for promoting tissue adhesion to soft tissue implants

• US 4,846,834 A
• Filed: 03/16/1988
• Issued: 07/11/1989
• Est. Priority Date: 05/27/1986
• Status: Expired due to Term

• Current Assignee: Clemson University
• Original Assignee: Clemson University
• Inventors: Cooke, Francis W., von Recum, Andreas F.
• Primary Examiner(s): Cannon, Alan W.
• Application Number:
  US07/168,894
• Time in Patent Office: 482 Days
• Field of Search: 623/11, 623/12, 623/16, 623/66, 623/1, 623/2, 623/13-15, 427/2, 427/37, 427/40, 427/50, 427/13, 430/128, 430/131, 128/335.5
• US Class Current: 128/898
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2310/00407 Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32

Abstract

A soft tissue implant comprises a flexible main body portion, having tissue-facing surfaces and a thin layer of pure titanium covering the tissue-facing surfaces. A method of promoting tissue adhesion of a soft tissue host to the tissue-facing surfaces of a soft tissue implant comprising a strip of polyethylene terephthalate velour comprises the steps of cleaning the strip with a low-residue detergent and rinsing same with fresh distilled water; refluxing the strip in distilled water for one hour at a temperature of less than 30° C.; drying the strip in a room-temperature desicator for several days; sterilizing the strip and packaging same; degasing the strip and storing same in a dust-free environment; removing the strip from the packaging and mounting the strip in a vacuum evaporator at an approximate angle of incidence of 90° from a pure titanium metal evaporant; evacuating the vacuum evaporator to a vacuum of about 2×10^-5 Torr; evaporating the titanium by direct resistence heating same; coating the strip with a layer of pure titanium on the order of one micron thick; and resterilizing and implanting the titanium-coated strip into the tissue host.

Claims

1. A method of promoting tissue adhesion of a host'"'"'s soft tissue bed to a soft tissue implant having a main body portion with tissue-facing surfaces, the method comprising the steps of:

coating the tissue-facing surfaces of the main body portion with a layer of pure titanium;

sterilizing the titanium coated implant;

forming a thin layer of titanium oxide over the pure titanium layer as the free surface of the implant; and

implanting the titanium coated implant into the host'"'"'s soft tissue bed.

2. A method as in claim 1, wherein:

said coating step comprises vapor deposition of pure titanium on the tissue-facing surfaces of the main body portion.

3. A method as in claim 2, wherein:

said vapor deposition includes direct resistance heating of a pure titanium structure.

4. A method of promoting tissue adhesion of a soft tissue bed to the tissue-facing surfaces of a soft tissue implant wherein the tissue-facing surfaces are formed of a flexible polymeric material, the method comprising the steps of:

coating the tissue-facing surfaces with a layer of pure titanium;

sterilizing the titanium coated implant;

forming a thin layer of titanium oxide over the pure titanium layer as the free surface of the implant; and

implanting the titanium coated implant into the host'"'"'s soft tissue bed.

5. A method as in claim 4, wherein:

said coating step comprises vapor deposition of pure titanium on the tissue-facing surfaces.

6. A method of promoting tissue adhesion of a host'"'"'s soft tissue bed to the tissue-facing surfaces of a soft tissue implant, wherein the tissue-facing surfaces are formed of a porous polymeric material, the method comprising the steps of:

coating the tissue-facing surfaces with a layer of pure titanium;

sterilizing the titanium coated implant;

forming a thin layer of titanium oxide over the pure titanium layer as the free surface of the implant; and

implanting the titanium coated implant into the host'"'"'s soft tissue bed.

7. A method as in claim 6, wherein:

said coating step comprises vapor deposition of pure titanium on the porous polymeric tissue-facing surfaces of the soft tissue implant.

8. A method of promoting tissue adhesion of a host'"'"'s soft tissue bed to the tissue-facing surfaces of a soft tissue implant wherein the tissue-facing surfaces are formed of a polymeric material having a roughened surface texture, the roughness being hills and valleys in a range of 1 to 100 micron depths and widths, the method comprising the steps of:

coating the tissue-facing surfaces with a layer of pure titanium;

sterilizing the titanium coated implant;

forming a thin layer of titanium oxide over the pure titanium layer as the free surface of the implant; and

implanting the titanium coated implant into the host'"'"'s soft tissue bed.

9. A method as in claim 8, wherein:

said coating step comprises vapor deposition of pure titanium on the roughened tissue-facing surfaces of the soft tissue implant.

10. A method of promoting tissue adhesion of a host'"'"'s soft tissue bed to a soft tissue implant having tissue-facing surfaces formed of a polymeric fabric, the method comprising the steps of:

coating the tissue-facing surfaces of the polymeric fabric with a layer of pure titanium;

sterilizing the titanium coated implant;

forming a thin layer of titanium oxide over the pure titanium layer as the free surface of the implant; and

implanting the titanium coated implant into the host'"'"'s soft tissue bed.

11. A method as in claim 10, wherein:

said coating step comprises vapor deposition of pure titanium on the polymeric fabric.

12. A method of promoting tissue adhesion of a host'"'"'s soft tissue bed to the tissue-facing surfaces of a strip of polyethylene terephthalate velour, the method comprising the steps of:

cleaning the strip with a low-residue detergent and rinsing same with fresh distilled water;

refluxing the strip in distilled water at a temperature of less than 30°

C. for more than one hour;

drying the strip in a room-temperature desiccator for more than one day;

degassing, sterilizing, packaging and storing the strip in a dust-free environment;

removing the strip from the packaging and mounting the strip in a vacuum evaporator at an approximate angle of incidence of 90°

from the source of the vacuum evaporator, said source comprising a pure titanium metal evaporant;

evacuating the vacuum evaporator to a vacuum of about 2 ×

10^-5 Torr;

resistance heating the titanium evaporant until the strip is coated with a layer of pure titanium on the order of 1 micron thick;

resterilizing the titanium coated strip;

forming a thin layer of titanium oxide over the pure titanium layer as the free surface of the implant; and

implanting the titanium coated strip into the host'"'"'s soft tissue bed.