Injectable alloplastic implants and methods of use thereof
View Patent ↗Described herein are injectable alloplastic implant compositions that are particularly useful for soft tissue defect augmentation. The compositions include microparticles, such as polymethylmethacrylate particles, and collagen as a suspending agent, wherein the collagen contains a reduced amount of low molecular weight gelatine compared to high molecular weight collagen. By controlling the molecular weight of the collagen in the compositions, the injectability, stability, and antigenicity of the alloplastic implant compositions can be improved.
1. An alloplastic implant composition comprising
microparticles having a diameter of about 5 to about 400 μm suspended in
an aqueous suspending agent, wherein the aqueous suspending agent comprises denatured type I collagen or atelocollagen, wherein the denatured type I collagen or atelocollagen has less than 10 wt % of the total weight as components of weight average molecular weight (Mw) 100,000 Daltons or lower, and greater than 70 wt % components of weight average molecular weight 100 kDa to 258 kDa,
wherein the polydispersity of the denatured type I collagen or atelocollagen expressed as Mw/Mn is 1.0 to 1.6, wherein Mw is weight average molecular weight and Mn is number average molecular weight.
2. The alloplastic implant composition of claim 1 , wherein the denatured type I collagen or atelocollagen is prepared from bovine or porcine collagen.
3. The alloplastic implant composition of claim 1 , wherein the pH of the aqueous suspending agent is 6.0 to 8.0 and the concentration of denatured type I collagen or atelocollagen in the aqueous suspending agent is 0.5 to 15 wt %.
4. The alloplastic implant composition of claim 1 , wherein the microparticles have a diameter of about 10 to about 200 μm.
5. The alloplastic implant composition of claim 1 , wherein the microparticles comprise a polymer or copolymer comprising a methacrylate monomer.
6. The alloplastic implant composition of claim 5 , wherein the polymer or copolymer is polymethylmethacrylate.
7. The alloplastic implant composition of claim 1 , wherein the composition is injectable through a 20 to 30 gauge needle.
8. The alloplastic implant composition of claim 1 , further comprising an anesthetic.
9. The alloplastic implant composition of claim 1 , wherein the alloplastic implant composition is stable for at least 30 days at a temperature of 20-25° C.
10. The alloplastic implant composition of claim 1 , wherein the alloplastic implant composition is stable for 72 hours at room temperature.
11. A method of augmenting a soft tissue defect, comprising injecting an alloplastic implant composition near the soft tissue defect, wherein the alloplastic implant composition comprises denatured type I collagen or atelocollagen that has less than 10 wt % of the total weight as components of weight average molecular weight (Mw) 100,000 Daltons or lower, and greater than 70 wt % components of weight average molecular weight 100 kDa to 258 kDa, wherein the polydispersity of the denatured type I collagen or atelocollagen expressed as Mw/Mn is 1.0 to 1.6, wherein Mw is weight average molecular weight and Mn is number average molecular weight.
12. The method of claim 11 , wherein the denatured type I collagen or atelocollagen is in the form of a suspending agent having suspended therein microparticles having a diameter of about 5 to about 400 μm.
13. The method of claim 11 , wherein the alloplastic implant composition is injected below the soft tissue defect at a junction of the dermis and subcutaneous fat.
14. The method of claim 11 , wherein the soft tissue defect is a result of aging, a wrinkle, a scar, a deformity related to trauma, or the result of plastic surgery.
15. The method of claim 11 , further comprising repeating injection of the alloplastic implant composition of claim 1 at one or more 2 week intervals.
16. The method of claim 12 , wherein the microparticles of the alloplastic implant composition have a diameter of about 10 to about 200 μm.
17. The method of claim 12 , wherein the microparticles of the alloplastic implant composition comprise a polymer or copolymer comprising a methacrylate monomer.
18. The method of claim 17 , wherein the polymer or copolymer is polymethylmethacrylate.
19. The method of claim 11 , wherein the alloplastic implant composition is injectable through a 20 to 30 gauge needle.
20. The method of claim 11 , wherein the alloplastic implant composition further comprises a topical anesthetic.
21. The method of claim 12 , wherein the denatured type I collagen or atelocollagen is prepared from bovine or porcine collagen.
22. The method of claim 11 , wherein the alloplastic implant composition is stable for at least 30 days at a temperature of 20-25° C.
23. The method of claim 11 , wherein the alloplastic implant composition is stable for 72 hours at room temperature.