Catheter having a long-lasting antimicrobial surface treatment

• US 5,520,664 A
• Filed: 01/11/1994
• Issued: 05/28/1996
• Est. Priority Date: 03/01/1991
• Status: Expired due to Term

• Current Assignee: Spire Corporation
• Original Assignee: Spire Corporation
• Inventors: Barry, John E., Sioshansi, Piran, Bricault, Raymond J. Jr.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/180,148
• Time in Patent Office: 868 Days
• Field of Search: 604/265, 604/280, 604/174, 623/1, 623/11, 623/901, 428/457, 428/35.7
• US Class Current: 604/265
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61F 2/20 Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• 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 2300/606 Coatings
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/10 Inorganic materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: C23C 14/20 : on organic substrates
• CPC Class Codes: C23C 14/505 : for rotation of the substrates
• CPC Class Codes: C23C 14/566 : using a load-lock chamber

Abstract

Catheters including at least one component having a tissue interfacing surface characterized by a substantially nonleaching surface treatment of antimicrobial metal. The component can be a subcutaneous cuff, and the antimicrobial metal can be silver. The process for implanting the silver atoms can include dry coating the tissue interfacing surface of the catheter by way of ion beam assisted deposition. Alternatively, the silver can be introduced into the tissue interfacing surface by ion implantation.

Claims

1. A catheter formed from a polymeric material and having an outer surface, the surface having embedded by ion beam assisted deposition therein atoms of an antimicrobial metal, the atoms extending in a subsurface stratum to a predetermined depth from the outer surface to form a substantially nonleaching surface treatment.

2. The catheter of claim 1 wherein the antimicrobial metal comprises at least one of silver, chromium, aluminum, nickel, tungsten, molybdenum, platinum, iridium, gold, silver, mercury, copper zinc and cadmium.

3. The catheter of claim 1 wherein the atoms of the antimicrobial metal are embedded to a depth of less than about 5 microns to ensure that the atoms of the antimicrobial metal are substantially nonleaching.

4. The catheter of claim 1 further comprising a uniform coating of the antimicrobial metal formed on the outer surface of the material.

5. The catheter of claim 1 wherein the outer surface has disposed between it and the atoms of the antimicrobial metal, atoms of an adhesion-promoting material which enhance the binding of the antimicrobial metal to the outer surface.

6. The catheter of claim 5 wherein the adhesion-promoting material comprises titanium.

7. The catheter of claim 5 wherein the adhesion-promoting material has disposed between it and the atoms of the antimicrobial metal, atoms of a barrier-forming material which form at least one of a barrier to degradation or diffusion of the adhesion-promoting atoms and an impediment to galvanic interaction between the antimicrobial metal and the adhesion-promoting material.

8. The catheter of claim 7 wherein the barrier-forming material comprises palladium.

9. The catheter of claim 1 wherein the outer surface has disposed between it and the atoms of the antimicrobial metal, atoms of titanium and palladium wherein the titanium atoms are predominantly located adjacent to the surface and interposed between the surface and the antimicrobial metal, and palladium atoms are predominantly interposed between the titanium atoms and the antimicrobial metal.

10. The catheter of claim 1 wherein the outer surface is a subcutaneous catheter cuff surface.

11. The catheter of claim 10 wherein the subcutaneous catheter cuff is formed from a porous polymeric material.

12. The catheter of claim 10 wherein the cuff is formed from a polymeric material.

13. The catheter of claim 11 wherein the surface has tissue interfacing fibers that form a fabric geometry having interstitial spaces between the fibers, and wherein the embedded atoms of the antimicrobial metal are embedded in the fibers, without filling the interstitial spaces in the fabric geometry, thus preserving the porosity of the subcutaneous cuff.

14. The catheter of claim 10 wherein the material comprises at least one of polyesters, fluropolymers, polyurethanes and silicones.

24. The subcutaneous cuff of claim 14 wherein the polymeric material comprises at least one of polyesters, fluropolymers, polyurethanes, and silicones.

25. The subcutaneous cuff of claim 14 wherein the atoms of the antimicrobial metal are embedded in the surfaces of fibers, which extend into the fabric geometry to a depth of greater than about 5 microns.

26. The subcutaneous cuff of claim 14 wherein the outer surfaces have disposed between them and the atoms of the antimicrobial metal, atoms of an adhesion-promoting material which enhance the binding of the antimicrobial metal to the outer surfaces, without filling in the interstitial spaces.

27. The subcutaneous cuff of claim 26 wherein the coating of the adhesion-promoting material has disposed between it and the atoms of the antimicrobial metal, atoms of a barrier-forming material which form at least one of a barrier to degradation or diffusion of the adhesion promoting atoms and an impediment to galvanic interaction between the antimicrobial metal and the adhesion-promoting atoms without filling the interstitial spaces.

15. A subcutaneous cuff formed from a porous polymeric material and having fibers that form a fabric geometry having interstitial spaces between the fibers, each of the fibers having an outer surface the outer surfaces having embedded by ion beam assisted deposition therein atoms of an antimicrobial metal, the atoms extending in a subsurface stratum to a predetermined depth from the outer surface of each fiber to form a substantially nonleaching surface treatment, and the interstitial spaces between the fibers being unchanged by the embedded atoms of the antimicrobial metal.

16. The subcutaneous cuff of claim 15 wherein the antimicrobial metal comprises at least one of silver, chromium, aluminum, nickel, tungsten, molybdenum, platinum, iridium, gold, silver, mercury, copper, zinc and cadmium.

17. The subcutaneous cuff of claim 15 wherein the atoms of the antimicrobial metal are embedded into the outer surfaces of the tissue interfacing fibers to a depth of between about 0.01 microns and 5 microns to ensure that the antimicrobial metal is substantially nonleaching.

18. The subcutaneous cuff of claim 15 further comprising coating of the antimicrobial metal formed on the outer surfaces of the tissue interfacing fibers.

19. The subcutaneous cuff of claim 15 wherein the outer surfaces have disposed between them and the atoms of the antimicrobial metal, atoms of an adhesion-promoting material which enhance the binding of the antimicrobial metal to the outer surfaces.

20. The subcutaneous cuff of claim 19 wherein the adhesion-promoting atoms comprise titanium.

21. The subcutaneous cuff of claim 19 wherein the adhesion-promoting material has disposed between it and the atoms of the antimicrobial metal, atoms of a barrier-forming material which form at least one of a barrier to degradation or diffusion of the adhesion-promoting atoms and an impediment to galvanic interaction between the antimicrobial metal and the adhesion-promoting atoms.

22. The subcutaneous cuff of claim 21 wherein the barrier-forming atoms comprise palladium.

23. The subcutaneous cuff of claim 15 wherein the outer surfaces have disposed between them and the atoms of the antimicrobial metal, atoms of titanium and palladium wherein the titanium atoms are predominantly located adjacent to the surface and interposed between the surface and the antimicrobial metal, and the palladium atoms are predominantly interposed between the titanium atoms and the antimicrobial metal.

28. A subcutaneous cuff formed from a porous polymeric material and having tissue interfacing fibers that form a fabric geometry having interstitial spaces between the fibers, each of the fibers having an outer surface, the outer surfaces having embedded therein atoms of an adhesion-promoting material and formed thereon a coating of the adhesion-promoting material, the coating of the adhesion-promoting material having embedded therein atoms of a barrier-promoting material and formed thereon a coating of the barrier-promoting material, the barrier-promoting material having atoms of silver metal embedded therein, wherein the adhesion-promoting material enhances the bonding of the silver to the outer surfaces, and the barrier material reduces galvanic interaction between the silver and the adhesion-promoting material.

29. A subcutaneous cuff for interfacing with subcutaneous tissue formed from a porous polymeric material and having an outer surface, having embedded by ion beam assisted deposition therein atoms of an antimicrobial metal, the atoms extending in a subsurface stratum to a predetermined depth from the outer surface to form a substantially nonleaching surface treatment.

30. The cuff of claim 29 wherein the outer surface has disposed between it and the atoms of the antimicrobial metal, atoms of an adhesion-promoting material, wherein the atoms of the adhesion-promoting material enhance the binding of the antimicrobial metal to the outer surface.

31. The cuff of claim 30 wherein the atoms of the adhesion-promoting material has disposed between it and the atoms of the antimicrobial metal, atoms of a barrier-forming material, wherein the atoms of the barrier-forming material form at least one of a barrier to degradation or diffusion of the adhesion-promoting atoms and an impediment to galvanic interaction between the antimicrobial metal atoms and the adhesion-promoting atoms.

32. The cuff of claim 31 wherein the barrier-forming material comprises palladium.

33. The cuff of claim 29 wherein the antimicrobial metal comprises at least one of silver, chromium, zirconium, aluminum, nickel, tungsten, molybdenum, tantalum, platinum, iridium, gold, silver, mercury, copper, zinc and cadmium.

34. The cuff of claim 30 wherein the adhesion-promoting material comprises titanium.

35. The cuff of claim 29 wherein the polymeric material comprises at least one of polyesters, fluropolymers, silicones, and polyurethanes.