Resorbable and biocompatible fibre glass compositions and their uses

Abstract

Biocompatible and resorbable melt derived glass compositions which include: SiO 2 60-70 weight-%, Na 2 O 5-20 weight-%, CaO 5-25 weight-%, MgO 0-10 weight-%, P 2 O 5 0.5-3.0 weight-%, B 2 O 3 0-15 weight-%, Al 2 O 3 0-5 weight-%, and which contain less than 0.05 weight-% potassium. Biocompatible and resorbable glass fibres manufactured from these glass compositions, medical devices containing fibres of the invention, the use of these compositions for the manufacture of glass fibre and the use of the fibres for the manufacture of medical devices are also disclosed.

1 . A biocompatible and resorbable melt derived glass composition comprising: 
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                   SiO 2   
                   60-70 
                   weight-%, 
                 
                     
                   Na 2 O 
                   5-20 
                   weight-%, 
                 
                     
                   CaO 
                   5-25 
                   weight-%, 
                 
                     
                   MgO 
                   0-10 
                   weight-%, 
                 
                     
                   P 2 O 5   
                   0.5-3.0 
                   weight-%, 
                 
                     
                   B 2 O 3   
                   0-15 
                   weight-%, 
                 
                     
                   Al 2 O 3   
                   0-5 
                   weight-% and 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
         comprising less than 0.05 weight-% potassium. 
       
     
     
         2 . The composition according to  claim 1  comprising less than 0.03 weight-% and preferably less than 0.01 weight-%, and most preferably less than 0.005 weight-% potassium. 
     
     
         3 . The bioactive composition according to  claim 1  or  2  characterized in that the composition comprises 
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                   SiO 2   
                   62-68 
                   weight-%, 
                 
                     
                   Na 2 O 
                   10-15 
                   weight-%, 
                 
                     
                   CaO 
                   8-20 
                   weight-%, 
                 
                     
                   MgO 
                   0-10 
                   weight-%, 
                 
                     
                   P 2 O 5   
                   0.5-3 
                   weight-%, 
                 
                     
                   B 2 O 3   
                   0-4 
                   weight-% and 
                 
                     
                   Al 2 O 3   
                   0-2.5 
                   weight-%. 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         4 . The composition according to  claim 1  or  2  characterized in that the composition comprises 
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                   SiO 2   
                   64-66 
                   weight-%, 
                 
                     
                   Na 2 O 
                   5-10 
                   weight-%, 
                 
                     
                   CaO 
                   10-15 
                   weight-%, 
                 
                     
                   MgO 
                   2-6 
                   weight-%, 
                 
                     
                   P 2 O 5   
                   0.5-3 
                   weight-%, 
                 
                     
                   B 2 O 3   
                   0-3 
                   weight-%, and 
                 
                     
                   Al 2 O 3   
                   0-1.0 
                   weight-%. 
                 
                     
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         5 . Biocompatible and resorbable glass fibre manufactured from a biocompatible and resorbable melt derived glass composition according to any of  claims 1  to  4 . 
     
     
         6 . Fibre according to  claim 5  characterized in that the time for the fibre to be fully resorbed in vitro in simulated body fluid (SBF), calculated using a resorption rate determined by dissolution in sink at +37° C. using the linear portion of the resorption curve, is 1-100, preferably 2-45, more preferably 3-15, even more preferably 4-70, still more preferably 5-30 and most preferably 6-15 months. 
     
     
         7 . Fibre according to  claim 5  or  6 , characterized in that the thickness of the fibre is <300 μm, preferably 1-75 μm, more preferably 5-30 μm, even more preferably 10-25 μm, still more preferably 10-20 μm and most preferably about 15 μm. 
     
     
         8 . Fibre according to  claim 5 ,  6  or  7  characterized in that the tensile strength of the fibre is 0.7-3 GPa, preferably 0.9-2.5 GPa, more preferably 1.0-2.0 GPa and most preferably 1.5-2.0 GPa. 
     
     
         9 . A medical device comprising fibre of any of  claims 5  to  8 . 
     
     
         10 . The medical device according to  claim 9 , characterized in that the device is fully based on or comprises chopped and/or continuous fibre according to any of  claims 5  to  8 ; and/or any kind of textile, woven or non-woven comprising fibre according to any of  claims 5  to  8 . 
     
     
         11 . The medical device according to  claim 9  or  10  characterized in that device is any kind of implant used within the body, preferably selected from the group consisting of a joint implant, an internal/external fixation device, a stent a, pin, a nail, a screw, a spike, a stud, a plate, and a device for supporting tissue or bone healing and/or regeneration. 
     
     
         12 . The medical device according to  claim 9 ,  10  or  11  characterized in that the amount of fibre according to any of  claims 4  to  7  is >10 volume-%, preferably >40 volume-%, more preferably >60 volume-%, most preferably >90 volume-% of the total volume of the fibres of said medical device. 
     
     
         13 . The medical device according to any of  claims 9  to  12  characterized in that the fibres are embedded in a continuous polymer matrix. 
     
     
         14 . The medical device according to  claim 13  characterized in that the polymer matrix comprises at least one polymer selected from the group consisting of polyglycolide (PGA); copolymers of glycolide, such as glycolide/L-lactide copolymers (PGA/PLLA), glycolide/trimethylene carbonate copolymers (PGA/TMC); polylactides (PLA); stereocopolymers of PLA, such as poly-L-lactide (PLLA), poly-DL-lactide (PDLLA), L-lactide/DL-lactide copolymers; other copolymers of PLA, such as lactide/tetramethylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d-valerolactone copolymers, lactide/ε-caprolactone copolymers; terpolymers of PLA, such as lactide/glycolide/trimethylene carbonate terpolymers, lactide/glycolidek-caprolactone terpolymers, PLA/polyethylene oxide copolymers; polydepsipeptides; unsymmetrically 3,6-substituted poly-1,4-dioxane-2,5-diones; polyhydroxy-alkanoates, such as polyhydroxybutyrates (PHB); PHB/b-hydroxyvalerate copolymers (PHB/PHV); poly-b-hydroxypropionate (PHPA); poly-p-dioxanone (PDS); poly-d-valerolactone; poly-ε-caprolactone; methylmethacrylate-N-vinyl pyrrolidone copolymers; polyesteramides; polyesters of oxalic acid; polydihydropyrans; polyalkyl-2-cyanoacrylates; polyurethanes (PU); polyvinyl-alcohol (PVA); polypeptides; poly-b-malic acid (PMLA); poly-b-alkanoic acids; polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides) and mixtures or thermosets thereof; and preferably selected from the group consisting of poly(ε-caprolactone), poly(ε-caprolactone-l-lactide) copolymers, polylactide-co-glycolide and polylactide. 
     
     
         15 . Use of the biocompatible and resorbable melt derived glass composition according to any of  claims 1  to  4  for the manufacture of glass fibre. 
     
     
         16 . Use of the fibres according to any of  claims 5  to  8  for the manufacture of a medical device.