Tissue injectable composition and method of use

• US 5,451,406 A
• Filed: 07/14/1994
• Issued: 09/19/1995
• Est. Priority Date: 07/14/1994
• Status: Expired due to Term

• Current Assignee: Carbon Medical Technologies, Inc.
• Original Assignee: Advanced UroScience, Inc. (Carbon Medical Technologies, Inc.)
• Inventors: Williams, Jeffrey M., Lawin, Timothy P.
• Primary Examiner(s): Kishore, Gollamudi S.
• Assistant Examiner(s): Webber, Pamela S.
• Application Number:
  US08/274,777
• Time in Patent Office: 432 Days
• Field of Search: 424/423, 424/400, 424/484, 514/492, 514/495, 600/30, 604/274
• US Class Current: 424/423
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61F 2310/00574 Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/303 Carbon
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• 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 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 5/02 Dextran; Derivatives thereof
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

An improved biocompatible composition consisting of physiologically stable microparticles carried in a lubricative suspension, solution, other fluid or gel is presented. The composition is intended to be delivered into the body through a small-bore needle, cannula, or catheter and to a tissue site for the purpose of augmenting the tissue site and surrounding area, thereby correcting a defect, filling a void, or strengthening the support structures of the tissue. The particles are a hard, metallic substance and are carbon-coated.

Claims

1. An injectable, biocompatible composition for tissue augmentation comprising:

a plurality of discrete particles in a carrier, wherein the particles are substrate particles with a carbon coating and have an average, transverse cross-sectional dimension of between 100 and 1,000 microns and the carrier is a biocompatible medium having sufficient fluidity to carry and deliver the particles, and has lubricative qualities.

2. The composition of claim 1 wherein:

said substrate particles are a metallic substance.

3. The composition of claim 1 wherein:

the substrate particles are selected from the group comprising stainless steel, titanium and titanium alloys, and their oxides.

4. The composition of claim 1 wherein:

said carbon coating is isotropic carbon.

5. The composition of claim 1 wherein:

said substrate particles are zirconium oxide.

6. The composition of claim 4 wherein:

said isotropic carbon coating is low temperature isotropic (LTI), pyrolyric carbon.

7. The composition of claim 6 wherein:

said substrate particles are zirconium oxide.

8. The composition of claim 4 wherein:

said isotropic carbon coating is ultra low temperature isotropic carbon which is vapor deposited.

9. The composition of claim 1 wherein:

said carbon coating is pyrolyric, isotropic carbon.

10. The composition of claim 8 wherein:

said substrate particles are gold or silver.

11. The composition of claim 1 wherein:

said carbon coating is a smooth, surface film.

12. The composition of claim 4 wherein:

said coating is a smooth, surface film.

13. The composition of claim 4 wherein:

said carbon coating is vitreous carbon.

14. The composition of claim 11 wherein:

said substrate particles are zirconium oxide.

15. The composition of claim 4 wherein:

said substrate particles are of rounded shape and said dimension is between 200 microns and 500 microns.

16. The composition of claim 1 wherein:

the substrate particles are radiopaque.

17. The composition of claim 1 wherein:

the carrier is a solution, suspension or gel of polysaccharides.

18. The composition of claim 17 wherein:

the polysaccharide is beta-glucan.

19. The composition of claim 1 wherein:

the carrier is a solution or suspension selected from the group comprised of hyaluronic acid, polyvinyl pyrrolidone or a hydrogel derivative thereof, dextran or a hydrogel derivative thereof, glycerol, polyethylene glycol, succinylated collagen, liquid collagen, or other polysaccharides or biocompatible organic polymers, either singly or in combination.

20. A method for augmenting tissue in a human patient comprising injecting into a tissue site in the patient a composition comprising a plurality of discrete, carbon coated substrate particles having an average, transverse, cross-sectional dimension of between 100 and 1,000 microns in a biocompatible carrier having sufficient fluidity to carry and deliver the particles and lubricative qualities.

21. The method of claim 20 wherein the tissue site is in the urinary tract.

22. The method of claim 21 wherein the tissue site is the urinary sphincter muscle.

23. The method of claim 21 wherein the tissue site is the urethra.