Body implants of extracellular matrix and means and methods of making and using such implants

• US 4,801,299 A
• Filed: 02/22/1984
• Issued: 01/31/1989
• Est. Priority Date: 06/10/1983
• Status: Expired due to Term

• Current Assignee: University Patents, Inc.
• Original Assignee: University Patents, Inc.
• Inventors: Duhamel, Raymond C., Brendel, Klaus
• Primary Examiner(s): Morgan, Kriellion
• Application Number:
  US06/582,504
• Time in Patent Office: 1,805 Days
• Field of Search: 3/1, 3/1.4, 3/1.9, 8/94.11, 8/94.15, 8/94.17, 8/94.18, 128/DIG. 8, 424/DIG. 13, 435/1, 623/1, 623/7, 623/16, 623/66
• US Class Current: 623/1.47
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/10 Hair or skin implants
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: Y10S 128/08 Collagen
• CPC Class Codes: Y10S 623/917 Collagen
• CPC Class Codes: Y10S 623/919 Bone
• CPC Class Codes: Y10S 623/923 Bone

Abstract

A sterile body implant is derived from a body structure having as its major protein component collagens in the form of extracellular matrix. The body structure is treated to remove cellular membranes, nucleic acids, lipids and cytoplasmic components. Such structures are implanted internally in the body or externally on the body in a variety of medical uses.

Claims

1. A sterile body implant comprising a body derived structure having as its major component collagens and elastin in the form of extracellular matrix from which has been removed cellular membranes, nucleic acids, lipids and cytoplasmic components.

2. A body implant in accordance with claim 1 wherein said implant is sized and dimensioned to be compatible with the histoarchitecture of a body portion to which the implant is to be attached.

3. A sterile body implant in accordance with claim 1 wherein said implant is treated shortly after said body structure is removed from the body and prior to substantial chemical cross-linking or change thereof with detergents.

4. A method of treating body tissue to remove cellular membranes, nucleic acids, lipids and cytoplasmic components and form extracellular matrix having as one major component collagens and making said body tissue suitable for use as a body implant, said method comprising extracting said tissue with a first and second detergent while maintaining said tissue in a suitable size and form for implantation in the body,

said second detergent being a strong anionic detergent and removing said detergents while maintaining said tissue in sterile form for use as a body implant,

said anionic detergent being selected from the group consisting of a water soluble salt of a sulfated higher aliphatic alcohol, sulfonated alkane and sulfonated alkylarene containing from 7 to 22 carbon atoms in a branched or unbranched chain.

6. A method of treating body tissue to remove cellular membranes, nucleic acids, lipids and cytoplasmic components and form extracellular matrix having as one major component collagens and making said body tissue suitable for use as a body implant, said method comprising extracting said tissue with a first an second detergent while maintaining said tissue in a suitable size and form for implantation in the body,

said second detergent being a strong anionic detergent and removing said detergents while maintaining said tissue in sterile form for use as a body implant,

said first detergent being admixed with a protease inhibitor.

7. A method of treating body tissue to remove cellular membranes, nucleic acids, lipids and cytoplasmic components and form extracellular matrix having as one major component collagens and making said body tissue suitable for use as a body implant, said method comprising extracting said tissue with a first and second detergent while maintaining said tissue in a suitable size and form for implantation in the body,

said second detergent being a strong anionic detergent and removing said detergents while maintaining said tissue in sterile form for use as a body implant,

said first detergent being admixed with a DNase.

8. A method of treating body tissue to remove cellular membranes, nucleic acids, lipids and cytoplasmic components and form extracellular matrix having as one major component collagens and making said body tissue suitable for use as a body implant, said method comprising extracting said tissue with a first and second detergent while maintaining said tissue in a suitable size and form for implantation in the body,

said second detergent being a strong anionic detergent and removing said detergents while maintaining said tissue in sterile form for use as body implant,

said body implant being a bone implant.

9. A method of treating body tissue to remove cellular membranes, nucleic acids, lipids and cytoplasmic components and form extracellular matrix having as one major component collagens and making said body tissue suitable for use as a body implant, said method comprising extracting said tissue with a first and second detergent while maintaining said tissue in a suitable size and form for implantation in the body,

said second detergent being a storing anionic detergent and removing said detergents while maintaining said tissue in sterile form for use as a body implant,

said body implant being a tooth implant.

5. A method in accordance with the method of claim 9 wherein said anionic detergent is sodium dodecylsulfate.

10. A method of treating body tissue to remove cellular membranes, nucleic acids, lipids and cytoplasmic components and form extracellular matrix having as one major component collagens and making said body tissue suitable for use as a body implant, said method comprising extracting said tissue with a first and second detergent while maintaining said tissue in a suitable size and form for implantation in the body,

said second detergent being a strong anionic detergent and removing said detergents while maintaining said tissue in sterile form for use as a body implant,

said body implant being a skin implant.

11. A method of implanting in a living body a whole structure for repairing the body, said structure being in the form of extracellular matrix high in collagen from which has been removed nucleic acids, lipids and cytoplasmic components leaving as its major component collagens with said removal being carried out by the use of at least one detergent, said method comprising implanting said structure in a living body,

said whole structure being a tooth.

12. A method of implanting in a living body a whole structure for repairing the body, said structure being in the form of extracellular matrix high in collagen from which has been removed nucleic acids, lipids and cytoplasmic components leaving as its major components collagens with said removal being carried out by the use of at least one detergent, said method comprising implanting said structure in a living body,

said whole structure being an area of the skin.

13. In a method of forming a body implant from a body tissue the improvement comprising treating said body tissue prior to cross-linking or unwanted deterioration of said tissue with a first non-denaturing detergent and a second denaturing detergent and forming said body implant therefrom suitable for use in implanting in a living body,

said detergents being used in sequence and a protease inhibitor being used along with said first detergent.

14. A method in accordance with the method of claim 13 wherein a DNase is admixed with said first detergent.

15. In a method of forming a body implant from a body tissue the improvement comprising treating said body tissue prior to cross-linking or unwanted deterioration of said tissue with a first non-denaturing detergent and a second denaturing detergent and forming said body implant therefrom suitable for use in implanting in a living body,

said second detergent being a strongly anionic detergent which is selected from the group consisting of a water soluble salt of a sulfated higher aliphatic alcohol, sulfonated alkane and sulfonated alkylarene containing from 7 to 22 carbon atoms in a branched or unbranched chain.