Methods and kits for aseptic filing of products

• US 8,187,556 B2
• Filed: 06/29/2011
• Issued: 05/29/2012
• Est. Priority Date: 10/29/2004
• Status: Active Grant

• Current Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Kadiyala, Sudhakar
• Primary Examiner(s): Conley, Sean E
• Assistant Examiner(s): Yoo, Regina M.
• Application Number:
  US13/172,808
• Publication Number:
  US 20110253583A1
• Time in Patent Office: 335 Days
• Field of Search: 422/291, 422/255, 422/261
• US Class Current: 422/261
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2/0017 Filtration
• CPC Class Codes: A61L 2/0088 Liquid substances
• CPC Class Codes: A61L 2/0094 Gaseous substances
• CPC Class Codes: A61L 2/022 Filtration
• 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

This invention relates to new methods & kits that minimize the risks and challenges associated with sterilization of multi-component medical devices.

Claims

1. A kit comprising:

a) a sterilized carrier enclosed in a sterilized housing comprising an inlet port; and

b) a source of biologic agent capable of being filter sterilized for addition to the carrier through the port,

wherein the inlet port comprises a microporous filter comprising pores no larger than 0.22 microns.

2. The kit of claim 1 wherein the housing is made from a material selected from the group consisting of polymeric and metallic materials.

3. The kit of claim 1, wherein the carrier is a biocompatible carrier.

4. The kit of claim 1, wherein the carrier comprises a bioabsorbable material.

5. The kit of claim 4, wherein the bioabsorbable material is a synthetic material.

6. The kit of claim 5, wherein the synthetic material is selected from the group consisting of polymers and copolymers of polyesters of [alpha]-hydroxycarboxylic acids, poly(L-lactide) (PLLA), polyglycolide (PGA), self-reinforced PLLA, self-reinforced PGA, poly-p-dioxanone, polyhydroxy acids, poly(ortho esters), poly(beta-hydroxybutyrate) (PHB), poly (PHB-hydroxyvaleric acid), pseudo-poly(aminoacids), polyiminocarbonates, poly(glycolide-co-trimethylene carbonate), polycaprolactone (PCL), polyvinyl alcohol (PVA), polyethylene oxide (PEO), and mixtures thereof.

7. The kit of claim 4, wherein the bioabsorbable material is a natural material.

8. The kit of claim 7, wherein the natural material is selected from the group consisting of collagen, recombinant collagen, laminin, elastin, fibronectin, fibrinogen, thrombospondin, gelatin, polysaccharides, poly-1-amino acids, hyaluronic acid, cellulose, alginates, chondroitin sulfate, chitosan, chitin, keratin, silk, small intestine submucosa (“

SIS”

), and combinations thereof.

9. The kit of claim 1, wherein the housing is selected from the group consisting of polymeric and metallic materials.

10. The kit of claim 9, wherein the housing is a polymeric material selected from the group consisting of polycarbonates, polyolefins, polyesters, polyethylenes, and combinations thereof.

11. The kit of claim 10, wherein the biologic agent is from the TGF-β

superfamily.

12. The kit of claim 11, wherein the agent is a bone morphogenic protein.

13. The kit of claim 12, wherein the agent is rhGDF-5.

14. The kit of claim 12, wherein the agent is BMP-2.

15. The kit of claim 12, wherein the agent is BMP-7.

16. The kit of claim 12, wherein the agent is CDMP-1.

17. The kit of claim 12, wherein the agent is GDF-5.

18. The kit of claims 12, wherein the carrier is collagen based.

19. The kit of claim 12, wherein the carrier is SIS.

20. The kit of claim 12 wherein the agent is GDF-5 and the carrier is SIS.

21. The kit of claim 1, wherein the biologic agent is selected from the group consisting of chemotactic agents;

therapeutic agents proteins, short chain peptides, active or inactive peptides, glycoproteins lipoproteins, cell attachment mediators, biologically active ligands, integrin binding sequence, ligands, growth and/or differentiation agents, epidermal growth factor, IGF-I, IGF-II, TGF-β

I-III, vascular endothelial growth factors, fibroblast growth factors, platelet derived growth factors, insulin-like growth factor, transforming growth factors, parathyroid hormone, parathyroid hormone related peptides, bFGF, TGF-β

superfamily factors, bone morphogenetic proteins, BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, sonic hedgehog, GDF5, BMP-14, MP-52, rhGDF-5, CDMP-1, GDF-6, GDF-8, CDMP-2, CDMP-3, PDGF, tenascin-C, hyaluronic acid, chondroitin sulfate, fibronectin, decorin, thromboelastin, thrombin-derived peptides, heparin-binding domains, heparin, heparin sulfate, DNA fragments and DNA plasmids, (as sole constituents or when incorporated into appropriate vectors,) and mixtures thereof.

22. A kit comprising:

a) a sterilizable carrier enclosed in a sterilizable housing comprising an inlet port;

b) a source of biologic agent capable of being filter sterilized for addition to the carrier through the port,

wherein the port contains a microporous filter comprising pores no larger than 0.22 microns.

23. The kit of claim 22, wherein the biologic agent is sterile.

24. The kit of claim 22, wherein the housing is selected from the group consisting of polymeric and metallic materials.