Method of soft tissue augmentation
Particles 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 includes particles of a viscoelastic medium, wherein a major volume of the particles are injectable gel particles 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.
1. A composition comprising particles of a viscoelastic medium comprising stabilized hyaluronic acid,
wherein said particles are injectable gel particles suitable for implantation having a size,
when subjected to a physiological salt solution, in the range of from 1.5 to 5 mm, wherein said physiological salt solution has the same osmolarity as a 0.154 M NaCl solution;
wherein said viscoelastic medium comprises cross-linked hyaluronic acid.
2. The composition of claim 1 , wherein said size is in the range of from 1.5 to 2.5 mm.
3. The composition of claim 1 , wherein said size is in the range of from 2.5 to 5 mm.
4. The composition of claim 1 , wherein the concentration of said viscoelastic medium in said particles, when subjected to said physiological salt solution, is in the range of from 5 to 100 mg/ml.
5. The composition of claim 1 , wherein the particles are injectable through a 20 gauge or larger needle by application of a pressure of 15-50 N.
6. The composition of claim 1 wherein the hyaluronic acid is cross-linked with 1, 4 -butanediol diglycidyl ether.
7. A soft tissue augmentation implant comprising particles of a viscoelastic medium comprising stabilized hyaluronic acid,
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 1.5 to 5 mm;
wherein said viscoelastic medium is selected from the group consisting of cross-linked hyaluronic acid;
wherein said physiological salt solution has the same osmolarity as a 0.154 M NaCl solution.
8. The soft tissue augmentation implant of claim 7 , wherein said size is in the range of from 1.5 to 2.5 mm.
9. The soft tissue augmentation implant of claim 7 , wherein said size is in the range of from 2.5 to 5 mm.
10. The composition of claim 1 , wherein the composition is formulated for use as a medicament.
11. An injectable soft tissue augmentation implant comprising injectable gel particles of claim 1 for use as a medicament.
12. A method of soft tissue augmentation in a mammal, comprising sub-epidermally administering the composition of claim 1 at a site in said mammal.
13. The method of claim 12 , wherein said administering is subcutaneous administration.
14. The method of claim 12 , wherein said administering is submuscular administration.
15. The method of claim 12 , wherein said administering is supraperiostal administration.
16. The method of claim 12 , wherein said size is in the range of from 1.5 to 2.5 mm.
17. The method of claim 12 , wherein said size is in the range of from 2.5 to 5 mm.
18. The method of claim 12 , wherein said site of soft tissue augmentation is selected from facial tissue and other tissues covered by exposed skin.
19. The method of claim 12 , wherein said administering is a single administration.
20. A method of diminishing migration or displacement of an implant, comprising administering subepidermal by injection a volume of 1 to 10 ml of a viscoelastic medium through a 18 to 20 gauge needle by application of a pressure of about 15 N to about 40 N at a site of said human subject, wherein the viscoelastic medium comprises gel particles comprising cross-linked hyaluronic acid and derivatives thereof, wherein the concentration of said cross-linked hyaluronic acid and derivatives thereof in said gel particles, when subjected to a physiological salt solution, is in the range of from 12 to 23 mg/ml, and wherein at least 50% (v/v) of said gel particles has a size range, when subjected to the physiological salt solution, in the range of from 3 to 4 mm, wherein the hyaluronic acid is cross-linked with 1,4-butanediol diglycidyl ether, whereby migration or displacement of the gel particles from the administration site is prevented or decreased.