Sterile polymerizable systems and kits and methods of their manufacture and use

• US 20050008528A1
• Filed: 08/09/2004
• Published: 01/13/2005
• Est. Priority Date: 11/28/2000
• Status: Abandoned Application

• Current Assignee: Orthovita Inc. (Stryker Corporation)
• Original Assignee: Orthovita Inc. (Stryker Corporation)
• Inventors: Erbe, Erik M., Wicklund, Jeffrey J., Prabhu, Vasanth, Wilkes, Anthony M.
• Application Number:
  US10/914,254
• Publication Number:
  US 20050008528A1
• Time in Patent Office: Days
• US Class Current: 422/1
• CPC Class Codes: A61L 2/0017 Filtration
• CPC Class Codes: A61L 2/0023 Heat
• CPC Class Codes: A61L 2/022 Filtration
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

The present invention overcomes the difficulties in the sterilization and delivery of viscous, multi-component compositions that require pre-mixing prior to usage by disclosing a sterile, multi-component, ready-to-use product wherein each component is sterilized independently and then assembled into a sterilized delivery kit. In certain preferred embodiments of the present invention, a sterile, polymerizable system is provided that comprises a plurality of sterile polymerizable monomers, said monomers having been sterilized by passing them through a filter; at least one sterile filler which has been exposed to conditions effective to render said filler sterile, and the sterile monomers and the sterile filler being blended together to form at least one substantially homogeneous blend contained within a sterile delivery vessel. Still other embodiments include a single-use kit that comprises a delivery gun, mix tips, and cartridges that comprise one or more pastes of the present invention that are housed within one or more pouches to ensure sterility of the internal contents.

Claims

1-24. -24. (Cancelled)

25. A sterile, polymerizable system comprising:

a plurality of sterile polymerizable monomers, said monomers having been sterilized by passing them through a filter;

at least one filler with a coupling agent having been sterilized under conditions sufficient to maintain the integrity of said coupling agent;

said sterile monomers and said sterile filler being blended together to form at least one substantially homogeneous blend contained within a sterile delivery vessel.

26. The system of claim 25 wherein at least two sterile substantially homogeneous blends are formed, each in a respective chamber of said delivery vessel, said chambers and vessel being formed such that the blends can be essentially simultaneously mixed together and delivered from said vessel.

27. The system of claim 25 wherein said coupling agent is silane.

28. The system of claim 25 wherein said conditions are gamma irradiation, ethylene oxide, dry heat, bright light or E-beam sterilization.

29. The system of claim 28 wherein the filler is sterilized by dry heat at a temperature of about 121°

C. for at least 8 hours.

30. The system of claim 28 wherein the filler is sterilized by dry heat at a temperature of about 140°

C. for at least 6 hours.

31. The system of claim 25 wherein an activator is added to the monomers prior to filtration.

32. The system of claim 25 wherein the delivery vessel comprises sterile one or more sterile cartridges, one or more sterile pistons, and one or more sterile caps.

33. The system of claim 25 wherein the delivery vessel is sterilized by gamma radiation.

34. The system of claim 25 wherein the delivery vessel is sterilized by auto clave.

35. The system of claim 25 wherein the delivery vessel is sterilized in an autoclave at about 121°

C. for at least 30 minutes.

36. A sterile, biologically compatible restorative composition, comprising:

a plurality of polymerizable monomers, said monomers having been sterilized by passing them through a filter;

at least one filler coated with silane, which has been exposed to conditions of time and temperature effective to render said filler sterile;

said monomers and filler being blended together to form at least one homogeneous composition contained within a sterile delivery vessel wherein the combined monomers and fillers are dischargeable from the sterile delivery vessel.

37. The composition of claim 36 wherein at least two sterile substantially homogeneous blends are formed, each in a respective chamber of said delivery vessel, said chambers and vessel being formed such that the blends can be essentially simultaneously mixed together and delivered from said vessel.

38. The composition of claim 36 wherein said conditions are gamma irradiation, ethylene oxide, dry heat, bright light or E-beam sterilization.

39. The composition of claim 38 wherein the filler is sterilized by dry heat at a temperature of about 121°

C. for at least 8 hours.

40. The composition of claim 38 wherein the filler is sterilized by dry heat at a temperature of about 140°

C. for at least 6 hours.

41. The composition of claim 36 wherein an activator is added to the monomers prior to filtration.

42. The composition of claim 36 wherein the delivery vessel comprises sterile one or more sterile cartridges, one or more sterile pistons, and one or more sterile caps.

43. The composition of claim 36 wherein the delivery vessel is sterilized by gamma radiation.

44. The composition of claim 36 wherein the delivery vessel is sterilized by auto clave.

45. The composition of claim 36 wherein the delivery vessel is sterilized in an autoclave at about 121°

C. for at least 30 minutes.