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
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
  • A61L29/16—Biologically active materials, e.g. therapeutic substances
• • 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
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
  • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
  • A61L2300/208—Quaternary ammonium compounds
• • 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
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
  • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir

Definitions

• the present invention generally relates to catheters and peripherally inserted central catheter (PICC) lines.
• PICC central catheter
• Vascular access products such as IV administration tubing, catheters and the associated caps, luers, Y sites, connectors, drip chambers, PICC lines, stopcocks and similar IV components such as needleless IV connectors having valve mechanisms are known in the art. Examples of such vascular access products are available from Health Line Medical Products of Centerville, Utah, and are visible on their website at www.hlic.net.
• valve mechanism for a needleless IV connector is the medical valve described in U.S. Patent No. 5,685,866 assigned to ICU Medical, Inc. who also makes such needleless IV connectors under the trademark MicroClave ® .
• One of the MicroClave ® needleless IV connectors is available with an antimicrobial treatment, where the antimicrobial treatment consists of ionic silver. Such ionic silver, however, is subject to leaching over time.
• a catheter comprising a component having a plurality of external surfaces, wherein at least one of said surfaces is coated with an antimicrobial treatment, wherein said antimicrobial material comprises a silane quaternary ammonium salt.
• a peripherally inserted central catheter line comprising a component having a plurality of external surfaces, wherein at least one of said surfaces is coated with an antimicrobial treatment, wherein said antimicrobial material comprises a silane quaternary ammonium salt.
• the silane quaternary ammonium salt may comprise 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride.
• Figs. 1A and IB show acute hemo-dialysis catheters according to one embodiment
• FIG. 1C shows a PICC line according to another em bodiment
• Fig. ID shows a peritonea l dialysis catheter according to another embodiment
• Figs. IE and IF show chronic hemo-dia lysis catheters according to another embodiment
• Fig. 2 is a schematic representation of a monomer that may be used in the embodiments described herein as an antimicrobia l treatment substance
• Fig. 3 is a schematic representation of a plura lity of the monomers shown in Fig. 2 as applied to a treated surface;
• FIG. 4A is a schematic representation of the monomer shown in Figs. 2 and 3 illustrating a first step in the manner by which the monomer destroys a microbe;
• Fig. 4B is a schematic representation of the monomer shown in Figs. 2 and 3 illustrating a second step in the manner by which the monomer destroys a microbe;
• Fig. 4C is a schematic representation of the monomer shown in Figs. 2 and 3 illustrating a third step in the ma nner by which the monomer destroys a microbe.
• catheters and PICC lines may provide a path into the patient's bloodstream, it is im portant that they do not harbor bacteria or other microbes.
• Novel catheters a nd PI CC lines are disclosed herein that not only provide the requisite properties for such vascular access products, but also eliminate bacteria on contact.
• the components of the catheters and PICC lines are either treated with or formed with an antimicrobial substance comprising a silane quaternary ammonium salt. Examples of catheters and PICC lines that may be so treated are shown in Figs. 1A-1F.
• FIGs. 1A and IB show an example of a first embodiment wherein acute hemodialysis catheters 10a and 10b have one or more of their external surfaces 50 coated with an antimicrobial treatment.
• Fig. 1C shows an example of a second embodiment wherein a PICC line 20 has one or more of its external surfaces 50 coated with an antimicrobial treatment.
• Fig. ID shows an example of a third embodiment wherein a peritoneal dialysis catheter 30 has one or more of its external surfaces 50 coated with an antimicrobial treatment.
• Figs. IE and IF show an example of a fourth embodiment wherein chronic hemodialysis catheters 40a and 40b have one or more of their external surfaces 50 coated with an antimicrobial treatment.
• the antimicrobial treatment may be applied to all surfaces 50 of the above catheters and PICC lines (10a, 10b, 20, 30, 40a, 40b). However, it is possible to obtain benefits by treating at least one of the surfaces treated with the antimicrobial treatment, and particularly the surfaces contacting the patient.
• the surfaces 50 of the catheters and PICC lines are coated with a n antimicrobial treatment that may be sprayed onto the surfaces using a solution and/or may be applied using wipes soaked in such a solution.
• a n antimicrobial treatment that may be sprayed onto the surfaces using a solution and/or may be applied using wipes soaked in such a solution.
• Suitable wipes and solutions are disclosed in commonly assigned U.S. Patent No. 8,491,922, the entire disclosure of which is incorporated herein by reference.
• the antimicrobial material is again one of the silane quaternary ammonium salts described above.
• the antimicrobial treatment solution contains 30-50 percent by volume isopropyl alcohol and 50-70 percent by volume antimicrobial treatment substance, which is preferably a silane quaternary ammonium salt having an unreacted organofunctional silane. If the antimicrobial treatment solution is applied by spraying or dipping, the solution most preferably includes 50 percent by volume isopropyl alcohol and 50 percent by volume of the unreacted antimicrobial treatment substance. If the solution is applied using the wipes, the solution is preferably 30 percent by volume isopropyl alcohol and 70 percent by volume of the unreacted antimicrobial treatment substance.
• the isopropyl alcohol may have a concentration of 70-90 percent by volume.
• the organofunctional silane does not react with the wipe substrates or the inside of the wipe container such that it is free to later react and permanently covalently bond with the inner and outer surfaces 50 of the vascular access products.
• Isopropyl alcohol is preferred as it evaporates quickly once the solution is wiped onto the treated surface to allow the unreacted organofunctional silane to more quickly react with the treated surface.
• the preferred organofunctional silane quaternary ammonium salt also prevents odor, staining and product deterioration that may be associated with microbe contamination.
• the preferred organofunctional silane quaternary ammonium salt is also beneficial because it permanently bonds to a treated surface, covers a broad spectrum of activity with no negative effects or drawbacks, and is easily incorporated a nd easily verifiable.
• the preferred organofunctional silane quaternary ammonium salt is designed to react and create a covalent bond with the surfaces of the plastic components. The reacted substance is held onto those surfaces until the covalent bond is broken. Tests have shown that most industrial cleaners or disinfectants will not remove the preferred antimicrobial treatment substance. The method of removal is by abrasion.
• the preferred silane quaternary ammonium salt includes an active ingredient of
• the silane quaternary ammonium salt preferably includes about 0.1 to 50 percent by weight of the 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride and most preferably includes about 5 percent by weight of the 3- (trimethoxysilyl) propyldimethyloctadecyl ammonium chloride.
• silane quaternary ammonium salts are available from Aegis Environments of Midland, Michigan, which is identified as "AEM 5772-5 Antimicrobial,” and from Piedmont Chemical Industries I, LLC of High Point, North Carolina, which is identified as “PROMOFRESH X 105.”
• the antimicrobial treatment solution with the isopropyl alcohol is available from MicrobeCare, LLC of Allenda le, Michigan, under the trademark MICROBECARETM.
• the above described silane quaternary ammonium salt is preferred because it is an organofunctional silane antimicrobial treatment substance that is substantially free from arsenic, silver, tin, heavy metals and polychlorinated phenols; copper; or a silver-ion emitter. In addition, it not only eliminates bacteria on contact, but it remains on the treated surfaces 50 and kills any bacteria subsequently contacting these surfaces. Such treatment preferably lasts at least one week, more preferably several months, and most preferably indefinitely.
• Fig. 2 shows a schematic representation of a monomer form 130 of a preferred organofunctional silane serving as the antimicrobial treatment substance.
• monomer 130 includes a silane base 131 for bonding to a surface 50, a positively charged nitrogen molecule 134, and a long molecular chain 132.
• the silane bases of these monomers covalently and permanently bond to each other and to the surface 50 to be treated in such a way that the long molecular chains are aligned and pointing outward from the surface 50.
• This tight bonding provides a micropolymer network that serves as a protective coating on the outside of the surface 50 that destroys any microbes that come into contact.
• Figs. 4A-4C The manner by which the preferred organofunctional silane destroys microbes is illustrated in Figs. 4A-4C.
• Such microbes may include bacteria, mold, mildew, algae, etc.
• the cell membrane 120 of the microbe is attracted to the treated surface 50 of the vascular access product and then is punctured by the long molecular chain 132 of the monomer 130.
• the monomer 130 penetrates further into the cell membrane 120 as shown in Fig. 4B.
• the cell membrane 120 Once the cell membrane 120 is penetrated deeply, it is physically ruptured by a sword-like action and then electrocuted by a positively charged nitrogen molecule 134 of the monomer 130, thus destroying the microbe as illustrated in Fig. 4C.
• the microbes are eliminated without "using up” any of the antimicrobial active ingredients, which remain on the surfaces 50 ready to continue protecting the treated item against further microbial contamination.
• the preferred organofunctional silane is designed to react and create a covalent bond with the surfaces 50 of the catheters and PICC lines. The reacted substance is held onto those surfaces 50 until the covalent bond is broken. Tests have shown that most industrial cleaners or disinfectants will not remove the preferred antimicrobial treatment substance. The method of removal is by abrasion.
• the antimicrobial material may be integrally formed within the silicone.
• silicones are formed of slurries processed at relatively low temperatures. These low temperatures allow the antimicrobial material to be mixed in with the slurry and therefore integrated within the resulting foam or silicone part. The percentage of a ntimicrobial material in the slurry may vary from 0.001% to 20% by weight.

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• 2015
  • 2015-08-20 WO PCT/US2015/046100 patent/WO2016029010A1/en active Application Filing
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