Method of soft tissue augmentation

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.

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.  
   
   
       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.  
   
   
       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.