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

• US 6,800,245 B1
• Filed: 11/28/2000
• Issued: 10/05/2004
• Est. Priority Date: 11/28/2000
• Status: Expired due to Term

• Current Assignee: Orthovita Inc. (Stryker Corporation)
• Original Assignee: Vita Special Purpose Corporation
• Inventors: Prabhu, Vasanth, Wilkes, Anthony M., Wicklund, Jeffrey J, Erbe, Erik M.
• Primary Examiner(s): McKane, Elizabeth
• Application Number:
  US09/723,445
• Time in Patent Office: 1,407 Days
• Field of Search: 422/1, 422/22, 422/34, 424/423, 606/94, 401/176, 604/218
• 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. A method of preparing a sterile, polymerizable blend, the method comprising the steps of:

sterilizing at least one filler with a coupling agent, via dry heat sterilization under conditions sufficient to maintain the integrity of said coupling agent;

sterilizing a plurality of polymerizable monomers via high pressure filtration; and

combining said monomers and filler together aseptically to form at least one homogeneous blend contained within a sterile delivery vessel from which the combined monomers and filler can be discharged.

2. The method of claim 1 wherein said coupling agent is silane.

3. The method of claim 1 wherein the filler is sterilized at a temperature of about 121°

C. for at least 8 hours.

4. The method of claim 1 wherein the filler is sterilized at a temperature of about 140°

C. for at least 6 hours.

5. The method of claim 1 wherein the delivery vessel comprises one or more sterile cartridges, one or more sterile pistons, and one or more sterile caps.

6. The method of claim 1 wherein the delivery vessel is sterilized by gamma radiation.

7. The method of claim 1 wherein the delivery vessel is sterilized in an autoclave.

8. The method of claim 7 wherein the delivery vessel is sterilized in an autoclave at about 121°

C. for at least 30 minutes.

9. A method of preparing a sterile, biologically compatible restorative composition, the method comprising the steps of:

applying to at least one filler with a coupling agent, dry heat under time and temperature conditions sufficient to sterilize said at least one filler with a coupling agent while maintaining the integrity of said coupling agent;

applying high pressure filtration sufficient to sterilize a plurality of polymerizable monomers; and

combining said monomers and filler together aseptically to form at least one homogeneous composition contained within a sterile delivery vessel.

10. A method of restoring tissue in an animal, the method comprising:

applying to the animal a sterile restorative compositions from a sterile delivery vessel;

the composition being formed by applying dry heat under time and temperature conditions sufficient to sterilize at least one filler with a coupling agent and applying dry heat under conditions sufficient to maintain the integrity of said coupling agent;

applying high pressure filtration sufficient to sterilize a plurality of polymerizable monomers;

combining said monomers and filler together aseptically to form at least one homogeneous composition contained within a sterile delivery vessel; and

applying said composition to said animal whereby the tissue may be restored.