Methods and kits for aseptic filling of products

• US 20060093513A1
• Filed: 10/29/2004
• Published: 05/04/2006
• 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
• Granted Patent: US 7,993,578 B2
• Time in Patent Office: Days
• US Class Current: 422/1
• 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 or resorptive
• 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 method of sterilization of a multi-component medical device comprising:

a) providing a carrier in a housing, the housing having a port;

b) sterilizing the carrier within the housing; and

c) introducing a biologic agent capable of being filter sterilized through the port for combination with the carrier.

2. The method of claim 1, wherein the carrier is a biocompatible carrier.

3. The method of claim 2, wherein the carrier comprises a bioabsorbable material.

4. The method of claim 3, wherein the bioabsorbable material is a synthetic material.

5. The method of claim 4, 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.

6. The method of claim 3, wherein the bioabsorbable material is a natural material.

7. The method of claim 6, 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.

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

9. The method of claim 8, wherein the housing is a polymeric material selected from the group consisting of polycarbonates, polyolefins, polyesters, polyethylenes, and combinations thereof.

10. The method 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.

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

superfamily.

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

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

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

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

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

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

18. The method of claims 12-17, wherein the carrier is collagen based.

19. The method of claims 12-17, wherein the carrier is SIS.

20. 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.

21. The kit of claim 20, wherein the housing is made from a material selected from the group consisting of polymeric and metallic materials.

22. The kit of claim 20, wherein the inlet port comprises a microporous filter comprising pores no larger than 0.22 microns.

23. 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.

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

25. The kit of claim 23, wherein the port contains a microporous filter comprising pores no larger than 0.22 microns.

26. The kit of claim 23, wherein the housing is selected from the group consisting of polymeric and metallic materials.