CA2426591A1 - Sterile polymerizable systems and kits and methods of their manufacture and use - Google Patents

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

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Publication number
CA2426591A1
CA2426591A1 CA002426591A CA2426591A CA2426591A1 CA 2426591 A1 CA2426591 A1 CA 2426591A1 CA 002426591 A CA002426591 A CA 002426591A CA 2426591 A CA2426591 A CA 2426591A CA 2426591 A1 CA2426591 A1 CA 2426591A1
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CA
Canada
Prior art keywords
sterile
filler
monomers
sterilized
delivery vessel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002426591A
Other languages
French (fr)
Other versions
CA2426591C (en
Inventor
Jeffrey J. Wicklund
Erik M. Erbe
Anthony M. Wilkes
Vasanth Prabhu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Orthovita Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2426591A1 publication Critical patent/CA2426591A1/en
Application granted granted Critical
Publication of CA2426591C publication Critical patent/CA2426591C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0017—Filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/022—Filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/206—Ethylene oxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—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, polimerizable 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 (24)

1. 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 sterile filler wherein said filler has been exposed to conditions sufficient to render said filler sterile;
said sterile monomers and said sterile filler being blended together to form at least one substantially homogeneous blend contained within a sterile delivery vessel.
2. The system of claim 1 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.
3. The system of claim 1 wherein the filler is treated or coated.
4. The system of claim 1 wherein said conditions are gamma irradiation, ethylene oxide, dry heat, bright light or E-beam sterilization.
5. The system of claim 4 wherein the filler is sterilized by dry heat at a temperature of about 121 °C for at least 8 hours.
6. The system of claim 4 wherein the filler is sterilized by dry heat at a temperature of about 140°C for at least 6 hours.
7. The system of claim 1 wherein an activator is added to the monomers prior to filtration.
8. The system of claim 1 wherein the delivery vessel comprises sterile one or more sterile cartridges, one or more sterile pistons, and one or more sterile caps.
9. The system of claim 1 wherein the delivery vessel is sterilized by gamma radiation.
10. The system of claim 1 wherein the delivery vessel is sterilized by auto clave.
11. The system of claim 1 wherein the delivery vessel is sterilized in an autoclave at about 121 °C for at least 30 minutes.
12. A method of preparing a sterile, polymerizable blend, the method comprising the steps of:
applying conditions sufficient to sterilize at least one filler;
passing a plurality of polymerizable monomers through a filter; and combining said monomers and filler together to form at least one homogeneous blend contained within a sterile delivery vessel wherein the combined monomers and fillers are dischargable from the sterile delivery vessel.
13. The method of claim 12 wherein the filler is treated or coated.
14. The method of claim 12 wherein said conditions are gamma irradiation, ethylene oxide, dry heat, bright light or E-beam sterilization.
15. The method of claim 14 wherein the filler is sterilized by dry heat at a temperature of about 121 °C for at least 8 hours.
16. The method of claim 14 wherein the filler is sterilized by dry heat at a temperature of about 140°C for at least 6 hours.
17. The method of claim 12 wherein the delivery vessel comprises one or more sterile cartridges, one or more sterile pistons, and one or more sterile caps.
18. The method of claim 12 wherein the delivery vessel is sterilized by gamma radiation.
19. The method of claim 12 wherein the delivery vessel is sterilized in an autoclave.
20. The method of claim 19 wherein the delivery vessel is sterilized in an autoclave at about 121 °C for at least 30 minutes.
21. 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 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 dischargable from the sterile delivery vessel.
22. A method of preparing a sterile, biologically compatible restorative composition, the method comprising the steps of:
applying dry heat under time and temperature conditions sufficient to sterilize at least one filler;
passing a plurality of polymerizable monomers through a filter; and combining said monomers and filler together to form at least one homogeneous composition contained within a sterile delivery vessel.
23. A shaped body made of a sterile polymerizable blend, said blend comprising:
a plurality of polymerizable monomers, said monomers having been sterilized by passing them through a filter;
at least one filler 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 blend contained within a sterile delivery vessel.
24. A method of restoring tissue in an animal, the method comprising the steps of:
applying dry heat under time and temperature conditions sufficient to sterilize at least one filler;
passing a plurality of polymerizable monomers through a filter combining said monomers and filler together 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.
CA002426591A 2000-11-28 2001-11-27 Sterile polymerizable systems and kits and methods of their manufacture and use Expired - Fee Related CA2426591C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/723,445 2000-11-28
US09/723,445 US6800245B1 (en) 2000-11-28 2000-11-28 Sterile polymerizable systems and kits and methods of their manufacture and use
PCT/US2001/044328 WO2002072156A2 (en) 2000-11-28 2001-11-27 Sterile polymerizable systems and kits and methods of their manufacture and use

Publications (2)

Publication Number Publication Date
CA2426591A1 true CA2426591A1 (en) 2002-09-19
CA2426591C CA2426591C (en) 2009-11-17

Family

ID=24906297

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002426591A Expired - Fee Related CA2426591C (en) 2000-11-28 2001-11-27 Sterile polymerizable systems and kits and methods of their manufacture and use

Country Status (6)

Country Link
US (4) US6800245B1 (en)
EP (1) EP1359944A4 (en)
JP (1) JP2004519290A (en)
CA (1) CA2426591C (en)
MX (1) MXPA03004526A (en)
WO (1) WO2002072156A2 (en)

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Also Published As

Publication number Publication date
EP1359944A4 (en) 2005-09-07
US6800245B1 (en) 2004-10-05
US20080319380A1 (en) 2008-12-25
WO2002072156A3 (en) 2002-12-05
US20100226820A1 (en) 2010-09-09
US20050008528A1 (en) 2005-01-13
MXPA03004526A (en) 2005-06-20
WO2002072156A2 (en) 2002-09-19
JP2004519290A (en) 2004-07-02
CA2426591C (en) 2009-11-17
EP1359944A2 (en) 2003-11-12

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