Method of manufacturing antimicrobial implants of polyetheretherketone

• US 8,821,912 B2
• Filed: 12/10/2010
• Issued: 09/02/2014
• Est. Priority Date: 12/11/2009
• Status: Active Grant

• Current Assignee: Difusion, Inc.
• Original Assignee: Difusion Technologies Incorporated
• Inventors: Crudden, Joseph J., Hafiz, Jami, Deaton, James E., Pepper, John R., Johns, Derrick
• Primary Examiner(s): Krass, Frederick
• Assistant Examiner(s): Shomer, Isaac
• Application Number:
  US13/512,702
• Publication Number:
  US 20130004585A1
• Time in Patent Office: 1,362 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: B29B 13/022 Melting the material to be shaped
• CPC Class Codes: B29B 13/06 by drying B29B13/08 takes precedence ; drying moulded articles or half products B29C37/0092
• CPC Class Codes: B29C 43/003 characterised by the choice of material
• CPC Class Codes: B29C 43/26 in several steps B29C43/30 takes precedence not applied
• CPC Class Codes: B29C 43/32 Component parts, details or accessories; Auxiliary operations
• CPC Class Codes: B29C 43/52 Heating or cooling
• CPC Class Codes: B29C 45/0001 characterised by the choice of material
• CPC Class Codes: B29C 45/0005 using fibre reinforcements
• CPC Class Codes: B29C 45/0013 using fillers dispersed in the moulding material, e.g. metal particles
• CPC Class Codes: B29C 45/0053 combined with a final operation, e.g. shaping injection-compression moulding B29C45/561
• CPC Class Codes: B29K 2071/00 Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2105/0011 Biocides
• CPC Class Codes: B29K 2105/04 cellular or porous
• CPC Class Codes: B29K 2105/12 of short lengths, e.g. chopped filaments, staple fibres or bristles
• CPC Class Codes: B29K 2105/16 Fillers
• CPC Class Codes: B29K 2307/04 : Carbon
• CPC Class Codes: B29K 2505/14 : Noble metals, e.g. silver, gold or platinum
• CPC Class Codes: B29K 2709/02 : Ceramics
• CPC Class Codes: B29K 2995/0056 : Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29K 2995/0072 : Roughness, e.g. anti-slip
• CPC Class Codes: B29L 2031/7532 : Artificial members, protheses
• CPC Class Codes: C08L 71/00 : Compositions of polyethers obtained by reactions forming an ether link in the main chain of polyacetals C08L59/00; of epoxy resins C08L63/00; of polythioether-ethers C08L81/02; of polyether-sulfones C08L81/06; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 71/12 : Polyphenylene oxides
• CPC Class Codes: Y10T 29/4998 : Combined manufacture including applying or shaping of fluent material

Abstract

Methods of fabricating implantable medical devices, preferably with PEEK, having antimicrobial properties, are disclosed. The antimicrobial effect is produced by incorporating ceramic particles containing antimicrobial metal cations into molten PEEK resin, which is subsequently allowed to cool and set in its final shape achieved by injection molding, cutting and machining or other techniques.

Claims

1. A method of making a load-bearing spinal antimicrobial implant, comprising drying polyetheretherketone resin to a residual moisture content of less than 0.1% moisture by weight, heating said dried polyetheretherketone resin to a temperature effective to melt said resin, blending into said molten resin a metal zeolite, that has been dried to a residual moisture content of less than 0.1% moisture by weight, cooling said blend, and forming said blend into said spinal implant.

2. The method of claim 1, wherein said temperature effective to melt said resin is from about 360 to about 400°

C.

3. The method of claim 1, wherein said metal zeolite comprises silver zeolite.

4. The method of claim 1, wherein said resin is dried by heating it to a temperature between about 120°

and 130°

C.

5. The method of claim 1, wherein said zeolite is dried at a temperature of about 400°

C.

6. The method of claim 1, wherein said blending step is carried out in a twin screw extruder.

7. The method of claim 1, wherein the amount of zeolite blended into said resin is from about 0.01 to about 20.0 wt %.

8. The method of claim 1, wherein said polyetheretherketone is porous.

9. The method of claim 8, wherein said polyetheretherketone has a porosity between 50% and 85% by volume.

10. The method of claim 1, wherein said polyetheretherketone is reinforced.

11. The method of claim 10, wherein said polyetheretherketone is reinforced with carbon fiber.

12. The method of claim 1, wherein the metal in said metal zeolite is selected from the group consisting of silver, copper, zinc, mercury, tin, lead, gold, bismuth, cadmium, chromium and thallium.