Textured micro implants

• US 5,571,182 A
• Filed: 10/10/1994
• Issued: 11/05/1996
• Est. Priority Date: 12/12/1988
• Status: Expired due to Term

• Current Assignee: Arthur A. Beisang, Arthur A. Beisang III, Robert A. Ersek
• Original Assignee: Arthur A. Beisang, Arthur A. Beisang III, Robert A. Ersek
• Inventors: Beisang, Arthur A. III, Beisang, Arthur A., Ersek, Robert A.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/321,571
• Time in Patent Office: 757 Days
• Field of Search: 623/11, 623/16, 623/66, 606/77, 606/92
• US Class Current: 623/23.73
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2002/30303 polypod-shaped
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61L 27/04 Metals or alloys
• CPC Class Codes: A61L 27/10 Ceramics or glasses
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: Y10S 623/924 Material characteristic

Abstract

An improved micro-implantation method and composition for filling depressed scars, unsymmetrical orbital floors, muscle, lip, and other soft tissue defects is provided for use in reconstructive surgery procedures. Textured micro particles having an outside diameter between about 30 microns and 3000 microns are used with an appropriate physiologic vehicle cannula and syringe and/or pressure delivery system into a predetermined locus. The particles provide long-term filling of defects without migration loss.

Claims

1. An injectable particulate implantation system for long-term augmentation of soft tissue, comprising in combination:

(a) an amount of generally soft, malleable, elastic, biologically compatible non-resorbin prosthetic particles dispersed in a non-retentive compatible physiological vehicle, said particles being further characterized by a rough surface texture having a plurality of surface irregularities generally randomly formed therein;

(b) said implantation system incorporating a combination of average particle size and average particle texture sufficient to cooperate in an autogenous manner to substantially prevent loss of said particles from an augmentation site, said particles remaining in situ to form part of a permanent implant.

2. The injectable implantation system of claim 1 being particularly characterized in that the range of average particle size is between 100 microns to 600 microns.

3. An injectable particulate implantation system for long-term augmentation of soft tissue, comprising in combination:

(a) biologically compatible particles of a relatively soft, resilient, non-resorbing material dispersed in a non-retentive compatible physiological vehicle, the particles being further characterized by a rough surface having a plurality of surfaces irregularities randomly formed therein and further comprising openings or pores;

(b) the particles having an average particle size generally between 30 and 3000 microns with a dimension of the openings formed by the pores within the particles being generally in a range between 10 angstroms and 500 microns;

(c) wherein the implantation system average particle size and average roughness of texture are sufficient in combination to, in an autogenous manner, substantially preclude migration of the particles from an augmentation site, such that the particles remain in situ to form part of a permanent implant.

4. The injectable implantation system of claim 3 wherein the particles further comprise an amount of at least one surface modifier to accomplish at least one of assisting in detoxification and promoting tissue ingrowth.

5. The injectable implantation system of claim 4 wherein the at least one surface modifier is incorporated into the micro particle prior to particle formation.

6. The injectable implantation system of claim 4 wherein the at least one surface modifier is selected from the group consisting of polyvinyl pyrrolidone, collagen and an hyaluronate.

7. The injectable implantation system of claim 6 wherein the surface modifier is dispersed in the physiological vehicle.

8. The injectable implantation system of claim 7 wherein the surface modifier is biologically active.

9. The injectable implantation system of claim 4 wherein the surface modifier is biologically active.

10. The injectable implantation system of claim 4 wherein the modifier is selected from the group consisting of fibronectin and cytokines.

11. The injectable implantation system of claim 3 being particularly characterized in that the compatible physiological vehicle is a bodily compatible fluid selected from the group consisting of hydrogels, glucose, starch, silicone fluid, lipid and a hyaluronate.

12. The injectable implantation system of claim 3 being particularly characterized in that the biologically inert particles are formed of bodily compatible solids selected from the group consisting of silicone rubbers, polytetrafluoroethylene, polyethylene, and other biologically inert polymer materials.

13. The injectable implantation system of claim 12 being particularly characterized in that the average particle size is at least 60 microns.

14. The injectable implantation system of claim 13 further characterized by micro particles having a textured surface of pores of an average size between about 10 microns and about 200 microns.

15. The injectable implantation system of claim 12 being particularly characterized in that the range of average particle size is between 100 microns to 600 microns.

16. The injectable implantation system of claim 3 being particularly characterized in that the average particle size is at least 60 microns.

17. The injectable implantation system of claim 16 being particularly characterized in that the biologically inert micro particles are of a generally uniform configuration.

18. The injectable implantation system of claim 3 being particularly characterized in that the range of average particle size is between 100 microns to 600 microns.

19. A non-migratory injectable particulate implantation system for long-term augmentation of soft tissue, comprising in combination:

(a) generally soft, resilient biologically inert, micro particles of a material of a material not resorbed by the body dispersed in a non-retentive compatible physiological vehicle, the micro particles being further characterized by a surface texture having a plurality of surface irregularities generally randomly formed therein;

(b) said implantation system having, in combination, an average particle size range and average particle texture such that migration from an injection site is substantially precluded in an autogenous manner and individual particle non-chronic inflammatory scar tissue encapsulation occurs, said particles thereby remaining in situ to form part of said implantation system.

20. An injectable particulate implantation system for long-term augmentation of soft tissue, comprising in combination:

(a) generally soft, resilient biologically inert nonresorbing implant particles having a generally rough surface dispersed in a non-retentive compatible physiological vehicle, the micro particles being of a generally uniform configuration and being further characterized by a surface texture having a plurality of surface irregularities separated by connective members generally randomly formed therein;

(b) the textured particles being formed of materials selected from the group consisting of silicone rubbers, polytetrafluoroethylene, polyethylene, and other biologically inert polymer materials, and having an average particle size generally between 60 and 3000 microns with dimensions of surface irregularities within the particles being generally in a range between 10 angstroms and 500 microns; and

(c) said implantation system incorporating an average particle size and average texture roughness to, in combination in an autogenous manner, substantially preclude migration of said particles from an injection site and achieve adequate guidance of fibroblasts such that a scar tissue pattern is developed that assumes a configuration that is generally in accordance with adjacent particle surfaces, said particles thereby remaining in situ to form a permanent part of said implantation system.