WO2010090098A1 - Procédé de fabrication d'un instrument médical antimicrobien et instrument médical antimicrobien - Google Patents

Procédé de fabrication d'un instrument médical antimicrobien et instrument médical antimicrobien Download PDF

Info

Publication number
WO2010090098A1
WO2010090098A1 PCT/JP2010/050958 JP2010050958W WO2010090098A1 WO 2010090098 A1 WO2010090098 A1 WO 2010090098A1 JP 2010050958 W JP2010050958 W JP 2010050958W WO 2010090098 A1 WO2010090098 A1 WO 2010090098A1
Authority
WO
WIPO (PCT)
Prior art keywords
silver
medical device
antibacterial
based particles
particles
Prior art date
Application number
PCT/JP2010/050958
Other languages
English (en)
Japanese (ja)
Inventor
直人 竹村
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2010549438A priority Critical patent/JP5639481B2/ja
Publication of WO2010090098A1 publication Critical patent/WO2010090098A1/fr

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/005Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104Silver, e.g. silver sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404Biocides, antimicrobial agents, antiseptic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/62Encapsulated active agents, e.g. emulsified droplets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0056Catheters; 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 relates to a method for producing an antibacterial medical device and an antibacterial medical device produced thereby.
  • the present invention relates to a central venous catheter that is placed in a blood vessel when performing central venous nutrition.
  • a central venous catheter which is one of medical devices
  • bacteria may enter the body through the skin puncture site or lumen of the catheter and cause bacterial infection. Severe infection can result in sepsis.
  • catheter-related bacteremia CR-BSI
  • the patient may die due to CR-BSI.
  • Patent Document 1 discloses an in-vivo insertion tube (catheter) having antibacterial properties by mixing a predetermined amount of an antibacterial agent such as a silver-substituted inorganic ion exchanger with a base material. ) Is described. Also in Patent Document 2, a silver compound is introduced (coating) on the surface of a base material, specifically, an amino acid derivative, an anionic surfactant, a compound having a carboxyl group or a sulfone group on the base material, etc. It is described that a urinary catheter having antibacterial properties is produced by absorbing a compound capable of binding to silver ions and then immersing it in an aqueous silver compound solution such as silver acetate.
  • an antibacterial agent such as a silver-substituted inorganic ion exchanger
  • JP-A-5-220216 (Claims 1 to 4)
  • JP-A-11-290449 (Claims 1 to 5)
  • the present invention was created to solve such problems, and its purpose is to provide a method for manufacturing an antibacterial medical device that can maintain antibacterial properties at a high level over a long period of time, and an antibacterial medical device manufactured thereby. Is to provide.
  • a method for manufacturing an antibacterial medical device includes a first step of manufacturing a medical device with a material containing an element capable of forming a complex with silver, A second step of introducing silver-based particles on the surface; and a third step of fixing the silver-based particles on the surface of the medical device by heat-treating the medical device into which the silver-based particles have been introduced. To do.
  • a medical device having an element capable of forming a complex with silver is produced.
  • the silver-based particles introduced into the surface of the medical device in the second step can form a complex with the element on the surface of the medical device or can form a complex with silver by the heat treatment in the third step. Due to the reducing action, pure silver particles are obtained, and the silver-based particles are firmly fixed to the surface of the medical device. As a result, the elution amount of silver-based particles eluted from the surface of the medical device during use, particularly the elution amount in the initial stage, can be reduced, so that the elution amount is maintained at a high level over a long period of time.
  • the method for manufacturing an antibacterial medical device produces a medical device using a material that does not contain an element capable of forming a complex with silver, and then introduces the element onto the surface of the medical device.
  • a first step a second step of introducing silver-based particles on the surface of the medical device into which the element has been introduced, and a heat treatment of the medical device into which the silver-based particles have been introduced to form a silver-based material on the surface of the medical device
  • a third step of fixing the particles is a third step of fixing the particles.
  • a medical device having an element capable of forming a complex with silver is produced.
  • the silver-based particles introduced into the surface of the medical device in the second step can form a complex with the element on the surface of the medical device or can form a complex with silver by the heat treatment in the third step. Due to the reducing action, pure silver particles are obtained, and the silver-based particles are firmly fixed to the surface of the medical device. As a result, the elution amount of silver-based particles eluted from the surface of the medical device during use, particularly the elution amount in the initial stage, can be reduced, so that the elution amount is maintained at a high level over a long period of time.
  • the method for manufacturing an antibacterial medical device according to the present invention further includes a fourth step of coating the surface of the medical device with an antithrombotic material after the third step.
  • antithrombogenicity is provided to the surface of a medical device by performing the 4th step which coat
  • the method for manufacturing an antibacterial medical device according to the present invention is characterized in that the element is one or more elements selected from S, N, O and P.
  • the silver introduced into the surface of the medical device in the heat treatment of the third step by producing a medical device having one or more elements selected from S, N, O and P in the first step.
  • the system particles easily form a complex, and the silver particles are more firmly fixed on the surface of the medical device.
  • the amount of silver-based particles eluted from the surface of the medical device during use is maintained at a higher level over a long period of time.
  • the method for manufacturing an antibacterial medical device according to the present invention is characterized in that, in the third step, the medical device into which the silver-based particles are introduced is heat-treated at 80 to 300 ° C.
  • the silver-based particles introduced to the surface of the medical device can easily form a complex, and the silver-based particles are more firmly fixed to the surface of the medical device.
  • the amount of silver-based particles eluted from the surface of the medical device during use is maintained at a higher level over a long period of time.
  • the amount of elution in the initial stage can be reduced, the amount of elution is maintained at a higher level over a long period of time.
  • the silver-based particles are pure silver particles or silver salt particles of any one or more of silver nitrate, silver acetate, silver azide and silver perchlorate. It is characterized by being.
  • the silver-based particles are pure silver particles, a complex containing pure silver particles is formed on the surface of the medical device, and the silver-based particles are firmly fixed on the surface of the medical device.
  • the silver-based particles are silver salt particles, the silver salt particles become pure silver particles due to the reducing action of elements capable of forming a complex with silver, and some of them form a complex containing pure silver particles.
  • the silver particles are firmly fixed on the surface of the medical device.
  • the amount of silver-based particles eluted from the surface of the medical device during use is maintained at a higher level over a long period of time.
  • the amount of elution in the initial stage can be reduced, the amount of elution is maintained at a higher level over a long period of time.
  • the antibacterial medical device according to the present invention is manufactured by the above manufacturing method.
  • grains (nanosilver particle) are firmly fixed to the surface of a medical device by manufacturing with the said manufacturing method.
  • the amount of silver-based particles (nanosilver particles) eluted from the surface of the medical device during use is maintained at a high level over a long period of time.
  • antithrombogenicity is imparted.
  • an antibacterial medical device in which the growth or infection of attached bacteria is suppressed for a long time and the antibacterial property can be maintained at a high level for a long time is produced.
  • an antibacterial medical device with antithrombogenic properties is produced.
  • the growth or infection of attached bacteria can be suppressed over a long period of time, and the antibacterial property can be maintained at a high level over a long period of time.
  • antithrombogenicity is imparted to the antibacterial medical device.
  • the antibacterial medical device is a medical device imparted with antibacterial properties, such as a central venous catheter, a Foley catheter, a gastric tube catheter, an infusion tube, a ventilator, a dressing material, a feeding tube, Sutures and the like.
  • the parts constituting the antibacterial medical instrument for example, the main body part 2, the tip part 3, the hub 4, the connecting tube 5 and the connector 6 constituting the central venous catheter 1 shown in FIG. Shall be included.
  • FIG. 1 is an external view showing the configuration of the central venous catheter.
  • the first method of the present invention includes a first step of producing a medical device with a material containing an element capable of forming a complex with silver, and a second step of introducing silver-based particles on the surface of the medical device. And a third step of fixing the silver-based particles on the surface of the medical device by heat-treating the medical device into which the silver-based particles have been introduced.
  • the contrast agent inorganic compounds such as barium sulfate, barium carbonate, bismuth oxide, bismuth subcarbonate and tungsten are used.
  • each step will be described.
  • the element capable of forming a complex with silver is an element having a lone electron pair, and preferably one or more elements selected from S, N, O and P.
  • a material containing these elements specifically, a material having a functional group containing an element (for example, thiol group, amino group, carboxyl group, phosphino group, etc.) is preferably a polymer material, such as polyurethane, Nylon, polycarbonate, polyester, silicone resin, or a resin composition obtained by combining two or more of these resins can be used.
  • a method for producing a medical device a conventional method for producing a medical device can be used, for example, extrusion molding, injection molding, or the like.
  • silver-based particles are introduced on the surface of the medical device.
  • the silver-based particles are preferably pure silver particles or silver salt particles, and more preferably nano silver particles or silver salt nanoparticles.
  • the nano silver particles or silver salt nanoparticles are silver particles having a particle size of 10 ⁇ 9 m to 10 ⁇ 8 m.
  • the silver-based particles only need to change into pure silver particles by heat treatment after the introduction, for example, not only pure silver particles but also silver nitrate other than pure silver, silver acetate, silver azide, excess Even silver salt particles of silver chlorate or a mixture thereof may be used as long as they can be converted into pure silver particles by heat treatment after introduction.
  • the solvent is preferably an organic solvent or a mixed solvent of water and an organic solvent.
  • the organic solvent tetrahydrofuran, dimethylformamide, dimethylacetamide, cyclohexanone, methyl ethyl ketone, dimethyl sulfoxide, acetone, methanol, ethanol, isopropanol, diethyl ether, hexane and the like can be used.
  • the organic solvent is preferably a hydrophobic organic solvent (for example, cyclohexanone, methyl ethyl ketone).
  • the concentration of the silver-based particle solution is preferably 10 to 10,000 ppm when the silver-based particles are nano silver particles.
  • the medical device into which the silver-based particles are introduced is heat-treated to fix the silver-based particles on the surface of the medical device. That is, a complex is formed by the element (for example, S, N, O, P) present on the surface of the medical device and silver-based particles. Thereby, silver-type particle
  • the silver-based particles are pure silver particles
  • the pure silver particles introduced onto the surface of the medical device by heat treatment or the like and an element capable of forming a complex with silver form a complex
  • the silver-based particles are medical. It is firmly fixed to the surface of the instrument.
  • the silver-based particles are silver salt particles
  • the silver salt particles introduced to the surface of the medical device by heat treatment or the like become pure silver particles due to the reducing action of an element capable of forming a complex with silver. .
  • a part of the pure silver particles and the element form a complex, and the silver-based particles are firmly fixed to the surface of the medical device.
  • the heat treatment temperature is preferably 80 to 300 ° C, more preferably 100 to 200 ° C.
  • the heat treatment temperature is less than 80 ° C.
  • silver-based particles are likely to be insufficiently fixed, and the amount of silver-based particles eluted at the initial stage is likely to increase when a medical instrument is used.
  • the elution amount of silver-based particles eluted from the medical device cannot be maintained at a high level over a long period of time, and it becomes difficult to maintain the antibacterial properties of the medical device over a long period of time.
  • the heat treatment temperature exceeds 300 ° C., changes in physical properties of the polymer material constituting the medical device and deterioration of the silver-based particles are likely to occur.
  • the heat treatment time is preferably 1 to 72 hours at 80 ° C. and 10 seconds to 1 hour at 300 ° C. If the heat treatment time is short, the fixation of the silver particles tends to be insufficient, and if the heat treatment time is long, the physical properties of the polymer material change and the silver particles are likely to deteriorate.
  • the second method of the present invention includes a first step of producing a medical device with a material that does not contain an element capable of forming a complex with silver, and then introducing the element onto the surface of the medical device; A second step of introducing silver-based particles onto the surface of the medical device into which the element has been introduced; and a third step of heat-treating the medical device into which the silver-based particles have been introduced to fix the silver-based particles on the surface of the medical device. And a step.
  • each step will be described.
  • the element capable of forming a complex with silver is an element having a lone pair of electrons, as in the first method, and is selected from S, N, O and P More than element is preferable.
  • a polymeric material or a metal material is preferable.
  • the polymer material polyethylene, polypropylene, polyvinyl chloride, or a resin composition obtained by combining two or more of these resins can be used.
  • the method for producing a medical device a conventional method for producing a medical device can be used as in the first method, and extrusion molding, injection molding, or the like can be used.
  • the first step as a method for introducing the element into the surface of the medical device, plasma treatment using a compound containing the element (for example, N 2 O gas) as a target, functional group containing the element (for example, (Graft polymerization of thiol group, amino group, carboxyl group) or coating of a compound containing the element can be used.
  • a compound containing the element for example, N 2 O gas
  • functional group containing the element for example, (Graft polymerization of thiol group, amino group, carboxyl group) or coating of a compound containing the element
  • the second step and the third step are the same as the first method described above, description thereof is omitted.
  • the second method for the purpose of ensuring the contrast of the medical device, multilayer forming of the contrast agent and uniform dispersion of the contrast agent material may be performed.
  • the method for manufacturing an antibacterial medical device according to the present invention includes the fourth step of coating the surface of the medical device with an antithrombogenic material after the third step in the first method or the second manufacturing method. Further, it may be included.
  • a method of coating a solution in which the antithrombotic material is dissolved by a dipping method, a spray method, or the like is used.
  • the solvent that dissolves the antithrombotic material include organic solvents such as acetone, methanol, ethanol, isopropanol, tetrahydrofuran, N, N-dimethylformamide, N, N-dimethylacetamide, and cyclohexanone.
  • the antithrombotic material is made of a biological material such as a mucopolysaccharide such as heparin or a protein such as urokinase, or a non-biological material such as a water-insoluble nonionic polymer.
  • the water-insoluble nonionic polymer is preferably at least one selected from the group consisting of polyalkoxyalkyl (meth) acrylates, polyalkylene glycols, insolubilized polyalkyl (meth) acrylamides and polyvinylpyrrolidone.
  • the antibacterial medical device is manufactured by the first or second method. And an antibacterial medical device is manufactured by the said 1st or 2nd method, A silver particle is firmly fixed to the surface of a medical device, and antibacterial property is maintained at a high level over a long period of time.
  • the antibacterial medical device to be manufactured is a central venous catheter, a Foley catheter, a gastric tube catheter, an infusion tube, a ventilator, a dressing material, a feeding tube, a suture, and the like. .
  • the central venous catheter 1 placed in the blood vessel shown in FIG. 1 is preferable.
  • the central venous catheter 1 includes a tube-shaped main body 2 having a lumen (not shown) through which a drug solution or the like flows.
  • the central venous catheter 1 includes a tube-shaped distal end portion 3 joined to the distal end side of the main body portion 2, a hub 4 joined to the proximal end side of the main body portion 2, and a drug solution joined to the hub 4.
  • a connection tube 5 for injection and a connector 6 joined to the proximal end side of the connection tube 5 may be provided.
  • the distal side refers to the side inserted into the body
  • the proximal side refers to the side operated by the operator.
  • the antibacterial medical device is provided as an antibacterial medical device by imparting antibacterial properties to each of a plurality of components constituting the antibacterial medical device by the first or second method, and then joining the components. Also good.
  • antibacterial properties are imparted by manufacturing the main body 2, the tip 3, the hub 4, the connection tube 5 and the connector 6 by the first or second method.
  • a joining method a joining method such as adhesion using an adhesive, fusion by heat or ultrasonic waves, fitting by thermal contraction, or the like is used.
  • Each component is made of the same or different material among the materials described above.
  • the heat treatment (third step) in the first or second method may be performed after joining the components.
  • an antithrombotic material may be coated (fourth step).
  • a method for using the antibacterial medical device according to the present invention will be described using a central venous catheter used for central venous nutrition as an example.
  • a central venous catheter used for central venous nutrition
  • the first method is to introduce a central venous catheter into the blood vessel through the outer lumen while the outer needle is removed after introducing a puncture needle having a separable outer tube into the blood vessel and leaving the outer mantle. Through the cannula method).
  • the inner needle is removed, the guide wire is introduced into the blood vessel with the mantle remaining, and the guide wire is removed after the mantle is removed.
  • a central venous catheter is inserted and the guide wire is removed (Seldinger method).
  • any method can be preferably used.
  • Example 1 Comparative Example 1
  • a polyurethane tube having an outer diameter of 2.5 mm and an inner diameter of 1.75 mm was prepared using polyurethane (manufactured by Nippon Milactone Co., Ltd., trade name: E990), and a nano silver colloid solution (nanopoly) was formed on the surface of the polyurethane tube.
  • an antibacterial tube was produced by heat treatment at 150 ° C. for 30 minutes.
  • the comparative example 1 produced the antibacterial tube like Example 1 except not giving the heat processing for 150 degreeC x 30 minutes.
  • Example 1 Samples having a total surface area of 32 ⁇ 5 cm 2 were cut from the antibacterial tubes of Example 1 and Comparative Example 1. Next, this sample was immersed in a suspension of Staphylococcus aureus (10 mL), and after immersion for a predetermined period, using this bacterial suspension and the sample, the silver elution amount (ppm / day) and the antibacterial activity, respectively. The change in value over time was measured. The silver elution amount was measured using an ICP emission analyzer (Seiko Instruments), and the antibacterial activity value was measured using the shake method defined in the Antibacterial Test Technology Council Standard. The results are shown in FIG. 2 and FIG. FIG. 2 is a graph showing the change over time in the silver elution amount, and FIG. 3 is a graph showing the change over time in the antibacterial activity value.
  • Example 1 compared with Comparative Example 1, the amount of elution of silver is at a high level even after an immersion time of 10 days. It was confirmed that the sex was maintained.
  • Example 2 comparative example 2
  • a polypropylene sheet having a thickness of 0.4 mm was produced using polypropylene, and this polypropylene sheet was subjected to plasma treatment in an atmosphere of N 2 O gas.
  • a nanosilver colloidal solution (trade name Nanomix, manufactured by Nanopoly Co., Ltd., 3000 ppm ethanol solution) was applied and dried on the surface of the plasma-treated sheet, and then heat-treated at 150 ° C. for 30 minutes to prepare an antibacterial sheet.
  • an antibacterial sheet was produced in the same manner as in Example 2 except that the plasma treatment was not performed on the polypropylene sheet.
  • FIG. 4 is a graph showing changes in the elution amount of silver.
  • Example 2 the amount of silver elution was lower than that in Comparative Example 2. Therefore, it was confirmed that by performing the plasma treatment, the silver elution amount in the initial stage of use can be lowered, so that the silver elution amount can be maintained at a high level for a long period of time and antibacterial properties can be maintained for a long period of time.
  • Example 3 to 6, Comparative Example 3 a polyurethane tube having an outer diameter of 2.5 mm and an inner diameter of 1.75 mm was prepared using polyurethane (manufactured by Nippon Milactone Co., Ltd., trade name: E990), and a nano silver colloid solution was formed on the surface of the polyurethane tube. (Nanopoly Co., Ltd., trade name Nanomix, 3000 ppm ethanol solution) is applied and dried, and then subjected to heat treatment under predetermined conditions (heat treatment temperature: 80, 100, 150, 190 ° C., heat treatment time: 0 to 25 hours) to be antibacterial A tube was prepared.
  • predetermined conditions heat treatment temperature: 80, 100, 150, 190 ° C., heat treatment time: 0 to 25 hours
  • the comparative example 3 produced the antibacterial tube like Example 3 except not heat-processing (room temperature: untreated). Then, samples were cut out from the antibacterial tubes of Examples 3 to 6 and Comparative Example 3 in the same manner as in Example 2, and the silver elution amount was measured. The measurement result of the silver elution amount is as shown in FIG. FIG. 5 is a graph showing changes in the elution amount of silver.
  • the amount of silver elution was lower than that in Comparative Example 3. Therefore, by performing heat treatment, it was confirmed that the silver elution amount in the initial stage of use can be lowered, so that the silver elution amount can be maintained at a high level over a long period of time and the antibacterial property can be maintained over a long period of time. Further, when the heat treatment temperature was 100 ° C. or higher, it was confirmed that the amount of elution of silver can be lowered by a short heat treatment, and thus the economy is excellent.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medicinal Chemistry (AREA)
  • Materials Engineering (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un procédé de fabrication d'un instrument médical antimicrobien, qui est caractérisé en ce qu'il comprend une première étape lors de laquelle un instrument médical est formé à partir d'un matériau qui contient un élément capable de former un complexe avec l'argent, une deuxième étape lors de laquelle des particules à base d'argent sont introduites sur la surface de l'instrument médical, et une troisième étape lors de laquelle les particules à base d'argent sont immobilisées sur la surface de l'instrument médical en soumettant l'instrument médical, sur lequel les particules à base d'argent ont été introduites, à un traitement thermique. L'invention concerne également un instrument médical antimicrobien qui est caractérisé en ce qu'il est fabriqué par le procédé de fabrication susmentionné.
PCT/JP2010/050958 2009-02-09 2010-01-26 Procédé de fabrication d'un instrument médical antimicrobien et instrument médical antimicrobien WO2010090098A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2010549438A JP5639481B2 (ja) 2009-02-09 2010-01-26 抗菌性医療器具の製造方法および抗菌性医療器具

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2009027151 2009-02-09
JP2009-027151 2009-02-09

Publications (1)

Publication Number Publication Date
WO2010090098A1 true WO2010090098A1 (fr) 2010-08-12

Family

ID=42542001

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2010/050958 WO2010090098A1 (fr) 2009-02-09 2010-01-26 Procédé de fabrication d'un instrument médical antimicrobien et instrument médical antimicrobien

Country Status (2)

Country Link
JP (1) JP5639481B2 (fr)
WO (1) WO2010090098A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0428375A (ja) * 1990-05-24 1992-01-30 Nippon Zeon Co Ltd 医療用チューブ
JPH04197363A (ja) * 1990-11-29 1992-07-16 Furukawa Electric Co Ltd:The カテーテルの製造方法
JP2005511144A (ja) * 2001-12-03 2005-04-28 シー・アール・バード・インク 微生物耐性医療用具、微生物耐性ポリマーコーティング及びその製造方法
JP2007029736A (ja) * 2005-07-27 2007-02-08 Cordis Corp カテーテルシャフトチューブおよびその作製方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0428375A (ja) * 1990-05-24 1992-01-30 Nippon Zeon Co Ltd 医療用チューブ
JPH04197363A (ja) * 1990-11-29 1992-07-16 Furukawa Electric Co Ltd:The カテーテルの製造方法
JP2005511144A (ja) * 2001-12-03 2005-04-28 シー・アール・バード・インク 微生物耐性医療用具、微生物耐性ポリマーコーティング及びその製造方法
JP2007029736A (ja) * 2005-07-27 2007-02-08 Cordis Corp カテーテルシャフトチューブおよびその作製方法

Also Published As

Publication number Publication date
JPWO2010090098A1 (ja) 2012-08-09
JP5639481B2 (ja) 2014-12-10

Similar Documents

Publication Publication Date Title
AU2009305471B2 (en) Medical device with controllably releasable antibacterial agent
JP7009574B2 (ja) 医療用装置への抗菌剤塗布
EP2968677B1 (fr) Dispositif avec traitement antithrombogénique et antimicrobien
US7820284B2 (en) Microbe-resistant medical device, microbe-resistant polymeric coating and methods for producing same
JP5799023B2 (ja) 迅速放出可能な抗菌剤を有する短時間使用のための医療デバイス
JP5820804B2 (ja) 抗菌性医療器具の製造方法
JPH0757236B2 (ja) 基材表面を凝塊形成防止性及び/或いは抗感染性にする方法
JPH02234767A (ja) 抗感染性および抗血栓形成性医療用品ならびにそれらの製法
JP2010029688A (ja) 医療器具表面コーティング用の結合層
US20040106912A1 (en) Method and composition for producing catheters with antibacterial property
JP2012520126A (ja) ニトロプルシド及び抗菌剤を含有する医療機器
US20140356901A1 (en) Method and Device for Detecting Device Colonization
JP5639481B2 (ja) 抗菌性医療器具の製造方法および抗菌性医療器具
JP2010179031A (ja) 抗菌性医療器具の製造方法および抗菌性医療器具
CN109758620B (zh) 一种长效抗菌可降解的输尿管支架管及其制备方法
WO2010090097A1 (fr) Cathéter antibactérien et son procédé de fabrication
CN108815583B (zh) 一种基于氨基纳米银分子刷的超亲水抗菌输尿管及其制备方法
JPH10248918A (ja) 医療用具及びその製造方法
CN110141782A (zh) 氧化石墨烯人工耳蜗电极及其制作方法
JP2005334216A (ja) 抗菌性カテーテル
CN108837185B (zh) 一种超亲水抗菌输尿管及其制备方法
JPH09276392A (ja) 医療用ガイドワイヤーおよびその製造方法
CN116212123A (zh) 一种抗菌水凝胶的制备方法和应用
CN112807492A (zh) 释放一氧化氮和氯己定的导管用于抗血小板和抗微生物的双重功能性

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 10738436

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2010549438

Country of ref document: JP

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 10738436

Country of ref document: EP

Kind code of ref document: A1