Method of soft tissue augmentation

• US 20050226936A1
• Filed: 03/28/2005
• Published: 10/13/2005
• Est. Priority Date: 04/08/2004
• Status: Abandoned Application

• Current Assignee: Q-Med Aktiebolag (Nestle SA)
• Original Assignee: Q-Med Aktiebolag (Nestle SA)
• Inventors: Agerup, Bengt
• Application Number:
  US11/090,141
• Publication Number:
  US 20050226936A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61L 15/20 containing organic materials
• CPC Class Codes: A61L 15/52 Water-repellants
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 27/20 Polysaccharides
• 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: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Particles according to the invention are made of a viscoelastic medium, are injectable gel particles, and have a size, when subjected to a physiological salt solution, in the range of from 1 to 5 mm. The particles are useful in a soft tissue augmentation implant. The implant comprises particles of a viscoelastic medium, wherein a major volume of the particles are injectable gel particles according to the invention. The implant is useful in a method of soft tissue augmentation in a mammal, including man, comprising subepidermal administration at a site in said mammal where soft tissue augmentation is desirable, of an implant according to the invention.

Claims

1. Particles of a viscoelastic medium, which are injectable gel particles having a size, when subjected to a physiological salt solution, in the range of from 1 to 5 mm.

2. Particles according to claim 1, wherein said size is in the range of from 1 to 2.5 mm.

3. Particles according to claim 1, wherein said size is in the range of from 2.5 to 5 mm.

4. Particles according to claim 1, wherein said viscoelastic medium is selected from the group consisting of polysaccharides and derivatives thereof.

5. Particles according to claim 1, wherein said viscoelastic medium is selected from stabilized glycosaminoglycans and derivatives thereof.

6. Particles according to claim 1, wherein said viscoelastic medium is selected from the group consisting of stabilized hyaluronic acid, stabilized chondroitin sulfate, stabilized heparin, and derivatives thereof.

7. Particles according to claim 1, wherein said viscoelastic medium is selected from the group consisting of cross-linked hyaluronic acid and derivatives thereof.

8. Particles according to claim 7, wherein the concentration of said viscoelastic medium in said gel particles, when subjected to a physiological salt solution, is in the range of from 5 to 100 mg/ml.

9. Particles according to claim 1, which are injectable through a 20 gauge or larger needle by application of a pressure of 15-50 N.

23. A medicament comprising the injectable gel particles according to claim 1.

24. An injectable soft tissue augmentation implant comprising injectable gel particles according to claim 1 suitable for use as a medicament.

25. A medicament comprising a major volume of particles of a viscoelastic medium according to claim 1 for therapeutic soft tissue augmentation in a mammal, including man, wherein said medicament is suitable for subepidermal administration at a site in said mammal where therapeutic soft tissue augmentation is desirable.

10. A method of producing injectable gel particles of a viscoelastic medium, comprising the steps of:

(i) manufacturing a gel with a desired concentration of said viscoelastic medium; and

(ii) mechanically disrupting said gel into gel particles having a size, when subjected to a physiological salt solution, in the range of from 1 to 5 mm.

11. A soft tissue augmentation implant comprising particles of a viscoelastic medium, wherein a major volume of said particles are injectable gel particles having a size, when subjected to a physiological salt solution, in the range of from 1 to 5 mm.

12. A soft tissue augmentation implant according to claim 11, wherein said size is in the range of from 1 to 2.5 mm.

13. A soft tissue augmentation implant according to claim 11, wherein said size is in the range of from 2.5 to 5 mm.

14. A method of soft tissue augmentation in a mammal, including man, comprising subepidermal administration at a site in said mammal where soft tissue augmentation is desirable, of an implant comprising injectable gel particles of a viscoelastic medium, a major volume of said particles having a size, when subjected to a physiological salt solution, in the range of from 1 to 5 mm.

15. A method according to claim 14, wherein said administration is subcutaneous administration.

16. A method according to claim 14, wherein said administration is submuscular administration.

17. A method according to claim 14, wherein said administration is supraperiostal administration.

18. A method according to claim 14, wherein said size is in the range of from 1 to 2.5 mm.

19. A method according to claim 14, wherein said size is in the range of from 2.5 to 5 mm.

20. A method according to claim 18, wherein said site of soft tissue augmentation is selected from facial tissue and other tissues covered by exposed skin.

21. A method according to claim 14, wherein said administration is a single administration.

22. A method according to claim 14, wherein said administration is a multiple-layer administration.