WO2011118680A1 - Procédé pour la production d'un instrument médical antimicrobien, et instrument médical antimicrobien - Google Patents

Procédé pour la production d'un instrument médical antimicrobien, et instrument médical antimicrobien Download PDF

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Publication number
WO2011118680A1
WO2011118680A1 PCT/JP2011/057096 JP2011057096W WO2011118680A1 WO 2011118680 A1 WO2011118680 A1 WO 2011118680A1 JP 2011057096 W JP2011057096 W JP 2011057096W WO 2011118680 A1 WO2011118680 A1 WO 2011118680A1
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Prior art keywords
antibacterial
solvent
medical device
tube
antibacterial agent
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PCT/JP2011/057096
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English (en)
Japanese (ja)
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直人 竹村
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テルモ株式会社
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Priority to JP2012507051A priority Critical patent/JP5820804B2/ja
Priority to CN201180004706.XA priority patent/CN102639162B/zh
Publication of WO2011118680A1 publication Critical patent/WO2011118680A1/fr

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    • 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
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L29/08—Materials for coatings
    • A61L29/10—Inorganic materials
    • A61L29/106—Inorganic materials other than carbon
    • 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
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • 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
    • 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
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/62—Encapsulated active agents, e.g. emulsified droplets
    • A61L2300/622—Microcapsules
    • 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 relates to a method for manufacturing an antibacterial medical device and an antibacterial medical device manufactured by the manufacturing method, and in particular, an antibacterial agent is fixed to the surface of the medical device.
  • a central venous catheter As one of antibacterial medical devices provided with antibacterial properties, a central venous catheter can be mentioned.
  • This central venous catheter is an instrument that is used by inserting the skin piercing portion of the central venous catheter into the subclavian vein or the jugular vein and placing the distal end portion of the central venous catheter in the superior vena cava for a long period of time.
  • the central venous catheter is given antibacterial properties in order to avoid the possibility of bacteria entering the body via the skin puncture site or lumen of the central venous catheter and causing bacterial infection.
  • the central venous catheter since the central venous catheter may be used after being placed in the body for a long period of time, it is desired that antibacterial properties be maintained for a long period of time.
  • Patent Document 1 as a method for manufacturing an antibacterial medical device, there is a manufacturing method in which an antibacterial agent is kneaded into a polymer compound or the like which is a raw material of the medical device.
  • Patent Document 2 there is a manufacturing method in which a medical device is immersed in a solvent in which an antibacterial agent is dissolved, the solvent is dried, and the surface of the medical device is coated with a layer of the antibacterial agent.
  • the antibacterial agent when the same amount of antibacterial agent is used, the antibacterial agent is applied to the surface of the medical device as compared to the case where the antibacterial agent is kneaded into a polymer compound or the like. More antibacterial agents are distributed on the surface of the medical device when this layer is coated. Therefore, the antibacterial property is more advantageous when the surface of the medical device is coated with the antibacterial agent layer.
  • JP-A-5-220216 Japanese Patent Laid-Open No. 11-290449
  • an antibacterial agent that is insoluble in a solvent such as silver zeolite when used to coat the surface of the central venous catheter, silver zeolite does not dissolve in the solvent, so that the central vein Fixed to the surface of the catheter. Therefore, during use, when the central venous catheter is inserted into the body, the antibacterial agent layer on the surface of the central venous catheter rubs, and the antibacterial agent easily falls off from the surface of the central venous catheter. There was a problem that it could not be maintained. Therefore, conventionally, an antibacterial medical device that can maintain antibacterial properties over a long period of time cannot be produced using an antibacterial agent that is not soluble in a solvent such as silver zeolite.
  • the present invention is able to fix an antibacterial agent on the surface of a medical device even if it is an antibacterial agent that is not soluble in a solvent, and can maintain antibacterial properties over a long period of time. It is an object to provide a method for manufacturing a medical device.
  • the method for manufacturing an antibacterial medical device is an antibacterial solution in which a mixed solvent is prepared by mixing a first solvent and a second solvent having different boiling points on the surface of at least a body insertion site of a medical device.
  • the antibacterial agent-containing solvent that adheres to the surface of the medical device in the attaching step includes the second solvent that can dissolve the medical device, but the first solvent Since the concentration of the second solvent is low, the surface of the medical device does not dissolve.
  • the drying step when the first solvent in the antibacterial agent-containing solvent starts to evaporate, the concentration of the second solvent increases, and the surface of the medical instrument is dissolved. And when the 2nd solvent evaporates, the melt
  • the method for producing an antibacterial medical device according to the present invention is characterized in that the boiling point of the first solvent is 30 ° C. or more lower than the boiling point of the second solvent. According to such a production method, since the first solvent has a boiling point of 30 ° C. or more lower than that of the second solvent, there is less risk of evaporating the second solvent during the evaporation of the first solvent. It is possible to reliably increase the concentration of the second solvent.
  • the first solvent does not dissolve the surface of the medical device, and the second solvent can dissolve the surface of the medical device. It is a characteristic.
  • the antibacterial-containing solvent contains the first solvent that does not dissolve the surface of the medical device in addition to the second solvent that dissolves the surface of the medical device. The concentration of the second solvent in the solvent is lowered. Therefore, even if the antibacterial-containing solvent is attached to the medical device, there is no possibility of dissolving the surface of the medical device unless the first solvent is evaporated. On the other hand, by evaporating the first solvent, it is possible to increase the concentration of the second solvent in the antibacterial agent-containing solvent and dissolve the surface of the medical device.
  • the drying step according to the present invention includes a first treatment step for evaporating the first solvent at room temperature, and a second treatment step for evaporating the second solvent by heating.
  • a manufacturing method it is possible to increase the concentration of the second solvent in the antibacterial agent-containing solvent and to dissolve the surface of the medical device by the first treatment step in which the first solvent evaporates at room temperature. Is possible.
  • the first treatment step evaporates the first solvent at room temperature, there is no possibility that the medical instrument is deformed by heat.
  • the second solvent evaporates in the second treatment step, the surface of the medical device is not dissolved, so that the dissolution surface of the medical device can be cured and the antibacterial agent can be deposited on the surface of the medical device. It becomes.
  • the antibacterial agent particles preferably include at least one of silver-supported silica particles, zeolite silver particles, and silver particles. According to such a manufacturing method, since silver excellent in antibacterial action is used as an antibacterial agent, an antibacterial medical instrument having a better antibacterial action can be manufactured.
  • a dispersant is added to the antibacterial agent-containing solvent. This is because according to such a production method, it is possible to stabilize the dispersibility of the antibacterial agent dispersed in the mixed solvent.
  • the antibacterial medical device according to the present invention is manufactured by the above-described method for manufacturing an antibacterial medical device. According to such an antibacterial medical device, since the antibacterial agent is welded to the surface of the medical device, the antibacterial agent does not easily fall off during use, and thus it is possible to maintain the antibacterial property for a long period of time. .
  • the antibacterial agent can be fixed on the surface of the medical device, and the antibacterial medical device can be maintained for a long time. Can be provided.
  • FIG. 1 is an overall view showing an overall configuration of a central venous catheter used in an embodiment of the present invention. It is the figure which observed the surface of the antibacterial tube in Example 1 from the perpendicular direction with the scanning electron microscope. It is the figure which observed the surface of the antimicrobial tube in the comparative example 2 from the perpendicular direction with the scanning electron microscope. It is the figure which observed the surface after rubbing the antibacterial tube in Example 1 from the perpendicular direction with the scanning electron microscope. It is the figure which observed the surface after rubbing the antimicrobial tube in the comparative example 2 from the perpendicular direction with the scanning electron microscope.
  • FIG. It is the figure which graphed the time-dependent change of the elution amount of the silver ion in the antibacterial tube in Example 1, and the antibacterial tube in the comparative example 3.
  • FIG. It is the figure which graphed the time-dependent change of the antibacterial activity value in the antibacterial tube in Example 1, and the antibacterial tube in the comparative example 3.
  • the surface of the antimicrobial tube in the comparative example 4 from the diagonal direction with the scanning electron microscope.
  • the method of manufacturing an antibacterial medical device according to the embodiment includes an attachment step of attaching an antibacterial agent-containing solvent to the surface of the medical device, and a drying step of drying the antibacterial agent-containing solvent attached to the surface of the medical device.
  • the central venous catheter 1 which is a medical instrument used in the embodiment will be described.
  • the central venous catheter 1 includes a tubular main body 2 having a lumen (not shown) through which a drug solution and the like flow, and a tubular distal end joined to the distal end side of the main body 2. 3, a hub 4 joined to the base end side of the main body 2, a connection tube 5 for injecting a chemical solution joined to the hub 4, and a connector 6 joined to the base end side of the connection tube 5.
  • a tubular main body 2 having a lumen (not shown) through which a drug solution and the like flow
  • a hub 4 joined to the base end side of the main body 2
  • a connection tube 5 for injecting a chemical solution joined to the hub 4
  • a connector 6 joined to the base end side of the connection tube 5.
  • This central venous catheter 1 inserts the main body 2 from the subclavian vein or the jugular vein, and places the tip 3 in the superior vena cava, etc., and performs high-calorie infusion, drug administration, blood collection, etc. from the connection tube 5.
  • It is a medical instrument made of polyurethane.
  • the body insertion portion of the medical instrument is the main body 2 and the distal end portion 3, and the surface of the body insertion portion of the central venous catheter 1 is the cylindrical main body 2 and the distal end. The inner surface and the outer surface with the part 3 are pointed out.
  • the central venous catheter 1 is used as a medical device.
  • a Foley catheter in addition to the human body such as a Foley catheter, a gastric tube catheter, an infusion tube, a ventilator, a dressing material, and a feeding tube. It can be placed for a long period of time, and can be applied to those formed of a polymer compound such as a thermoplastic resin excluding metals or a thermoplastic resin.
  • the antibacterial agent-containing solvent is a solvent in which an antibacterial agent is dispersed in a mixed solvent.
  • the mixed solvent refers to a solvent produced by mixing the first solvent and the second solvent.
  • This second solvent is a solution capable of dissolving the surface of the medical device to be adhered, and is a high-boiling solvent having a higher evaporation temperature than the first solvent described later. Therefore, whether or not the second solvent can dissolve the medical device is relatively determined by the raw materials constituting the medical device.
  • the central venous catheter 1 is made of polyurethane, N-methyl-pyrrolidone (NMP), N, N-dimethylformamide (DMF), Examples include di-methylacetamide (DMA) and cyclohexanone.
  • NMP N-methyl-pyrrolidone
  • DMF N-dimethylformamide
  • DMA di-methylacetamide
  • cyclohexanone The boiling point of the second solvent, which is such a high boiling point solvent, is 100 ° C. to 250 ° C., and the evaporation temperature is higher than that of the first solvent described later.
  • the first solvent is a solvent for lowering the concentration of the second solvent in the mixed solvent by mixing with the second solvent, and does not dissolve the medical device and evaporates at a temperature lower than the second solvent. It is. Examples include methanol and ethanol.
  • the boiling point of the first solvent which is such a low-boiling solvent is 50 to 100 ° C., and is preferably 30 ° C. or more lower than the boiling point of the second solvent which is a high-boiling solvent.
  • the mixing ratio of the second solvent and the first solvent is a mixing ratio at which the medical device does not dissolve, and the volume ratio of mixing the second solvent and the first solvent is in the range of 1: 3 to 3: 1. It is desirable.
  • Antibacterial agents include inorganic antibacterial agents having antibacterial properties, or organic antibacterial agents that do not lose antibacterial properties even when mixed in a mixed solvent.
  • silver-supported silica particles, zeolite silver particles, silver particles examples include copper particles, platinum fine particles, titanium oxide particles, zinc oxide particles, tungsten oxide particles, silver sulfadiazine, carbon nanotubes, silver-supporting carbon nanotubes, and silver-coated carbon nanotubes. Then, an antibacterial agent is added to the mixed solvent and stirred, and the antibacterial agent-containing solvent is produced by dispersing the antibacterial agent in the mixed solvent.
  • a dispersant may be added to the mixed solvent.
  • the dispersing agent is adsorbed on the particle surface and functions to suppress aggregation and sedimentation between the particles due to electrical repulsion and steric hindrance.
  • the types of dispersants are classified into chemical structures having molecular skeletons of polyether-based, polyester-based, acrylic-based, urethane-based and amine-based, carboxylic acid-based, and phosphoric acid-based adsorbing groups. Select the optimal dispersant according to the type of antibacterial agent and solvent used.
  • Attachment of the antibacterial agent-containing solvent to the surface of the central venous catheter is performed by immersing the central venous catheter in the antibacterial agent-containing solvent.
  • the drying process of the embodiment includes three processes, a first treatment process for evaporating the first solvent in the antibacterial agent-containing solvent, a second treatment process for evaporating the second solvent in the antibacterial agent-containing solvent, and a third treatment process. It consists of a process.
  • the first treatment step is a step for evaporating the first solvent in the antibacterial agent-containing solvent and leaving the concentration of the second solvent in the antibacterial agent-containing solvent high, for example, by leaving it at room temperature for about 1 hour. Therefore, the temperature of the first treatment step is not particularly limited, but when it is room temperature, most of the first solvent such as methanol can be evaporated. And according to a 1st process process, the density
  • the time of the first treatment step is such that the polymer material of the dissolved central venous catheter does not cover the entire surface of the antibacterial agent, that is, the central vein is exposed to the extent that a part of the antibacterial agent is exposed from the dissolved polymer material. It is necessary to dissolve the surface of the catheter.
  • the second treatment step is a step of evaporating the second solvent by heat treatment.
  • the temperature and time of the heat treatment for evaporating the second solvent are not particularly limited, but it should be noted that if the temperature is too high, the central venous catheter may be deformed.
  • the third treatment step is a step of performing heat treatment to evaporate the remaining antibacterial agent-containing solvent. Therefore, the heat treatment in the third treatment step is only required to evaporate the second solvent, and it is not necessary to heat the antibacterial agent-containing solvent to the boiling point temperature of the second solvent. Moreover, it is necessary that the central venous catheter is not deformed by high temperature. According to this, the polymer material constituting the dissolved central venous catheter is cured and a part of the antibacterial agent is welded, and a part of the antibacterial agent is exposed and fixed to the surface of the central venous catheter. Become.
  • the manufacturing method of the antibacterial medical device in embodiment was demonstrated, according to the manufacturing method of embodiment, the surface of the central venous catheter which is a medical device was welded in the form where a part of antibacterial agent was exposed. It becomes possible to manufacture a central venous catheter having an antibacterial agent fixed on its surface.
  • Example 1 the antibacterial tube A was manufactured by the manufacturing method described in the above-described embodiment, and a peel test was performed to determine whether or not the antibacterial agent welded to the surface of the antibacterial tube A easily falls off.
  • the second solvent that dissolves the medical device is used, the shape of whether or not the antibacterial tube A is deformed was also confirmed.
  • a mixed solvent of the present invention is prepared with a different solvent, and Comparative Examples 1 and 2 manufactured with the mixed solvent are prepared, whether the medical device is deformed, and antibacterial agent peeling The test was also performed.
  • Example 1 In Example 1, a polyurethane tube was used as a medical instrument. This polyurethane tube is made of polyurethane (product name “E990”, manufactured by Nippon Miractran Co., Ltd.) as a raw material, and is formed with an outer diameter of 2.1 mm and an inner diameter of 1.3 mm.
  • As the second solvent 5 mL of N-methyl-pyrrolidone was prepared.
  • 5 mL of methanol was prepared as the first solvent, and both were mixed to produce a mixed solution.
  • the mixing ratio between the second solvent and the first solvent is 1: 1.
  • zeolite silver particles manufactured by Sinanen Zeomic Co., Ltd., trade name “Zeolite Silver AJ-10D”
  • the antibacterial agent-containing solvent A contained in The zeolite silver particles have a silver content of 5%.
  • 30 cm in length of the polyurethane tube was immersed in the antibacterial agent-containing solvent A and attached.
  • the first treatment step is allowed to stand at room temperature (20 ° C.) for 1 hour
  • the second treatment step is heat-treated in an oven at 50 ° C. for one hour
  • the third treatment step is performed at an oven temperature of 80 ° C.
  • the antibacterial tube A in which the antibacterial material was welded to the surface was manufactured by raising the temperature to 0 ° C. and drying for 2 hours.
  • the weight after coating the tube A with the antibacterial agent-containing solvent A increased by 0.0342 g.
  • Comparative Examples 1 and 2 The antibacterial medical devices of Comparative Example 1 and Comparative Example 2 were produced with the antibacterial agent-containing solvent B or the antibacterial agent-containing solvent C, which is a solvent different from the mixed solvent of Example 1.
  • the mixed solvent B of Comparative Example 1 consisted of only the second solvent, and 10 mL of N-methyl-pyrrolidone was prepared.
  • 0.3 g of the same zeolite silver particles product name “Zeolite Silver AJ-10D”, manufactured by Sinanen Zeomic Co., Ltd.
  • An antibacterial agent-containing solvent B containing particles at a rate of 3 wt / v% was produced.
  • the antimicrobial tube B was manufactured through the same drying process as Example 1.
  • the mixed solution C of Comparative Example 2 was composed of only the first solvent, and 10 mL of methanol was prepared. Then, 0.3 g of the same zeolite silver particles (product name “Zeolite Silver AJ-10D” manufactured by Sinanen Zeomic Co., Ltd.) as in Example 1 is prepared in the mixed solvent C, separated into the mixed solvent C, and the zeolite silver An antibacterial agent-containing solvent C containing particles at a rate of 3 wt / v% was produced. And the antimicrobial tube C was manufactured through the same drying process as Example 1.
  • zeolite silver particles product name “Zeolite Silver AJ-10D” manufactured by Sinanen Zeomic Co., Ltd.
  • the antibacterial tube A and the antibacterial tube C did not change in the shape of the tube.
  • the antibacterial tube B has a deformed shape. That is, in the mixed solvent B composed only of the second solvent, the surface of the medical instrument is excessively dissolved, so that the shape of the medical instrument itself has changed.
  • the manufactured antibacterial tube A was confirmed to be welded to the surface of the antibacterial tube A with a part of the antibacterial agent exposed.
  • the antibacterial tube C also has an antibacterial agent on the surface of the antibacterial tube C as shown in FIG.
  • the surface of the antibacterial tube A and the antibacterial tube C was rubbed with a cotton swab with a cotton swab. According to this, as shown in FIG. 4, the antibacterial agent is still fixed on the surface of the antibacterial tube A after rubbing, and the antibacterial agent does not easily fall off from the surface of the antibacterial tube A. It could be confirmed. On the other hand, as shown in FIG. 5, the surface of the antibacterial tube C after rubbing did not have the antibacterial agent, and the antibacterial agent easily dropped off.
  • the antibacterial tube B was welded in a state where the amount of dissolution on the tube surface was large and the antibacterial agent was buried. Therefore, although the antibacterial agent does not peel off, the antibacterial agent is not exposed, so that silver ions do not elute, and the antibacterial tube B cannot exhibit the antibacterial property.
  • Comparative Example 3 an antibacterial tube D produced by a kneading method was prepared, and the elution amount and antibacterial activity value of the silver ions were measured.
  • the antibacterial tube D of Comparative Example 3 was made from the same polyurethane as that of Example 1 (product name “E990” manufactured by Nippon Milactolan Co., Ltd.).
  • the antibacterial agent a powder of zeolite silver particles was prepared in the same manner as in Example 1.
  • the silver zeolite particles were mixed at a rate of 5 wt / v% with respect to the polyurethane to produce an antibacterial tube D having an outer diameter of 2.1 mm and an inner diameter of 1.3 mm.
  • the zeolite silver particle contained in the antibacterial tube D is 0.0348 g, and has the same amount of antibacterial agent as 0.0342 g of the antibacterial tube A.
  • the antibacterial tube A and the antibacterial tube D were cut to a length of 30 cm (total surface area is about 32 ⁇ 5 cm 2 ) and immersed in 10 ml of a staphylococcus aureus suspension medium solution.
  • the elution amount (ppm) of silver ion was measured using the solution after immersion using the ICP emission spectrometer.
  • the measurement of the elution amount of silver ions was carried out by measuring the elution amount of silver ions over time by separately measuring after 1 day, 7 days, 14 days, 21 days, and 28 days after immersion in the solution. . The measurement results are shown in FIG.
  • the antibacterial activity value was measured using a solution in which the antibacterial tube A and the antibacterial tube D were immersed, according to the shake method defined in the Antibacterial Test Technology Council Standard.
  • the antibacterial activity value was measured by measuring the change over time of the antibacterial activity value by separately measuring after 0 days, 7 days, 14 days, 21 days, and 28 days after immersion in the solution. The measurement results are shown in FIG.
  • the antibacterial tube A of Example 1 and the antibacterial tube D of Comparative Example 3 are reduced, the elution amount of silver ions is reduced as time passes.
  • the antibacterial tube A of 1 had a greater silver ion elution amount than the antibacterial tube D of Comparative Example 3.
  • the antibacterial activity value of the antibacterial tube A of Example 1 maintained a high value without decreasing. That is, from the above, the antibacterial tube A of Example 1 was able to exhibit antibacterial properties over a long period of time.
  • the antibacterial tube D of Comparative Example 3 showed an antibacterial activity value equivalent to that of Example 1 until 14 days later, but the antibacterial activity value decreased every 21 days and 28 days later. did. Therefore, it was proved that the antibacterial tube A of Example 1 exhibited a high antibacterial activity value in the long term as compared with the antibacterial tube D of Comparative Example 3.
  • Example 2 Comparative Example 4
  • Example 2 the antibacterial tube E was produced in the same manner as in Example 1.
  • an antibacterial tube F was produced in the same manner as Comparative Example 2.
  • the surface state of the antibacterial agent welded to the surface of the scanning electron microscope manufactured by Hitachi High-Technologies Corporation, model: S-3400N
  • shooting direction: tube surface In comparison with the oblique direction, magnification: 3000 times
  • cross-sectional photograph magnification: 3000 times
  • the antibacterial agent is photographed in a granular form.
  • the antibacterial tube E of Example 2 was welded to the surface of the antibacterial tube E in a state where a part of the antibacterial agent was exposed. Therefore, in the antibacterial tube E, it turned out that an antibacterial agent does not fall out easily in the said peeling test.
  • the antibacterial tube F of the comparative example 4 has confirmed that there was an antibacterial agent on the surface of the antibacterial tube F, as shown in FIG. 10, FIG. Therefore, in the antibacterial tube F, it turned out that an antibacterial agent falls out easily in the said peeling test.

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Abstract

La présente invention concerne un procédé pour produire un instrument médical antimicrobien, caractérisé en ce qu'il comprend : une étape d'adhésion d'un solvant contenant un agent antimicrobien, qui est produit par dispersion de particules de l'agent antimicrobien dans une solution mixte comprenant un premier solvant et un deuxième solvant ayant des points d'ébullition différents l'un de l'autre, sur la surface d'au moins une partie d'un instrument médical qui doit être insérée dans le corps ; et une étape de séchage du solvant contenant l'agent antimicrobien adhéré sur la surface de l'instrument médical.
PCT/JP2011/057096 2010-03-26 2011-03-24 Procédé pour la production d'un instrument médical antimicrobien, et instrument médical antimicrobien WO2011118680A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2012507051A JP5820804B2 (ja) 2010-03-26 2011-03-24 抗菌性医療器具の製造方法
CN201180004706.XA CN102639162B (zh) 2010-03-26 2011-03-24 抗菌性医疗器具的制造方法和抗菌性医疗器具

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JP2010073742 2010-03-26
JP2010-073742 2010-03-26

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PCT/JP2011/057096 WO2011118680A1 (fr) 2010-03-26 2011-03-24 Procédé pour la production d'un instrument médical antimicrobien, et instrument médical antimicrobien

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016007440A1 (fr) * 2014-07-08 2016-01-14 Becton, Dickinson And Company Actionneur antimicrobien pour ouvrir l'orifice latéral d'un cathéter à orifices
US9675793B2 (en) 2014-04-23 2017-06-13 Becton, Dickinson And Company Catheter tubing with extraluminal antimicrobial coating
US9695323B2 (en) 2013-02-13 2017-07-04 Becton, Dickinson And Company UV curable solventless antimicrobial compositions
US9750928B2 (en) 2013-02-13 2017-09-05 Becton, Dickinson And Company Blood control IV catheter with stationary septum activator
US9789279B2 (en) 2014-04-23 2017-10-17 Becton, Dickinson And Company Antimicrobial obturator for use with vascular access devices
US10232088B2 (en) 2014-07-08 2019-03-19 Becton, Dickinson And Company Antimicrobial coating forming kink resistant feature on a vascular access device
US10376686B2 (en) 2014-04-23 2019-08-13 Becton, Dickinson And Company Antimicrobial caps for medical connectors
US10493244B2 (en) 2015-10-28 2019-12-03 Becton, Dickinson And Company Extension tubing strain relief

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WO2017138716A1 (fr) * 2016-02-11 2017-08-17 주식회사 아폴론 Composition destinée à un cathéter et son procédé de fabrication
CN108577908B (zh) * 2018-05-15 2020-11-17 温州医科大学附属第一医院 一种肛门拉勾及其制备方法

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6211457A (ja) * 1985-05-30 1987-01-20 ザ・トラスティ−ス・オブ・コロンビア・ユニバ−シティ・イン・ザ・シティ−・オブ・ニュ−ヨ−ク 耐感染性高分子材料の製造方法
JPH0217071A (ja) * 1988-02-11 1990-01-22 Univ Columbia 感染抵抗性組成物の製造方法
JPH03503375A (ja) * 1987-11-23 1991-08-01 コロラド　バイオメディカル　インコーポレイテッド 抗菌活性作用を行う医用装置、それに抗菌剤を注入する方法及び抗菌性組成物
JPH09308676A (ja) * 1996-05-23 1997-12-02 Unitika Ltd 医療用具及びその製造方法
JPH11504241A (ja) * 1995-04-24 1999-04-20 ベイラー・カレッジ・オブ・メディスン 抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法
JP2004523267A (ja) * 2000-12-22 2004-08-05 ザ トラスティース オブ コロンビア ユニバーシティ イン ザ シティ オブ ニューヨーク 抗菌性医用装置
JP2008508321A (ja) * 2004-07-30 2008-03-21 アクリメッド インコーポレイテッド 抗菌銀組成物
WO2008150867A2 (fr) * 2007-05-29 2008-12-11 Innova Materials, Llc Surfaces ayant des particules et procédés associés
WO2010090097A1 (fr) * 2009-02-09 2010-08-12 テルモ株式会社 Cathéter antibactérien et son procédé de fabrication

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005334216A (ja) * 2004-05-26 2005-12-08 Terumo Corp 抗菌性カテーテル
AU2009292197B8 (en) * 2008-09-11 2014-04-24 Bacterin International, Inc. Elastomeric article having a broad spectrum antimicrobial agent and method of making

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6211457A (ja) * 1985-05-30 1987-01-20 ザ・トラスティ−ス・オブ・コロンビア・ユニバ−シティ・イン・ザ・シティ−・オブ・ニュ−ヨ−ク 耐感染性高分子材料の製造方法
JPH03503375A (ja) * 1987-11-23 1991-08-01 コロラド　バイオメディカル　インコーポレイテッド 抗菌活性作用を行う医用装置、それに抗菌剤を注入する方法及び抗菌性組成物
JPH0217071A (ja) * 1988-02-11 1990-01-22 Univ Columbia 感染抵抗性組成物の製造方法
JPH11504241A (ja) * 1995-04-24 1999-04-20 ベイラー・カレッジ・オブ・メディスン 抗菌剤を注入されたカテーテルおよび医学移植物並びにその注入方法
JPH09308676A (ja) * 1996-05-23 1997-12-02 Unitika Ltd 医療用具及びその製造方法
JP2004523267A (ja) * 2000-12-22 2004-08-05 ザ トラスティース オブ コロンビア ユニバーシティ イン ザ シティ オブ ニューヨーク 抗菌性医用装置
JP2008508321A (ja) * 2004-07-30 2008-03-21 アクリメッド インコーポレイテッド 抗菌銀組成物
WO2008150867A2 (fr) * 2007-05-29 2008-12-11 Innova Materials, Llc Surfaces ayant des particules et procédés associés
WO2010090097A1 (fr) * 2009-02-09 2010-08-12 テルモ株式会社 Cathéter antibactérien et son procédé de fabrication

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9750928B2 (en) 2013-02-13 2017-09-05 Becton, Dickinson And Company Blood control IV catheter with stationary septum activator
US11357962B2 (en) 2013-02-13 2022-06-14 Becton, Dickinson And Company Blood control IV catheter with stationary septum activator
US9695323B2 (en) 2013-02-13 2017-07-04 Becton, Dickinson And Company UV curable solventless antimicrobial compositions
US10589063B2 (en) 2014-04-23 2020-03-17 Becton, Dickinson And Company Antimicrobial obturator for use with vascular access devices
US9789279B2 (en) 2014-04-23 2017-10-17 Becton, Dickinson And Company Antimicrobial obturator for use with vascular access devices
US9956379B2 (en) 2014-04-23 2018-05-01 Becton, Dickinson And Company Catheter tubing with extraluminal antimicrobial coating
US10376686B2 (en) 2014-04-23 2019-08-13 Becton, Dickinson And Company Antimicrobial caps for medical connectors
US11357965B2 (en) 2014-04-23 2022-06-14 Becton, Dickinson And Company Antimicrobial caps for medical connectors
US9675793B2 (en) 2014-04-23 2017-06-13 Becton, Dickinson And Company Catheter tubing with extraluminal antimicrobial coating
US10232088B2 (en) 2014-07-08 2019-03-19 Becton, Dickinson And Company Antimicrobial coating forming kink resistant feature on a vascular access device
WO2016007440A1 (fr) * 2014-07-08 2016-01-14 Becton, Dickinson And Company Actionneur antimicrobien pour ouvrir l'orifice latéral d'un cathéter à orifices
US11219705B2 (en) 2014-07-08 2022-01-11 Becton, Dickinson And Company Antimicrobial coating forming kink resistant feature on a vascular access device
US10493244B2 (en) 2015-10-28 2019-12-03 Becton, Dickinson And Company Extension tubing strain relief
US11904114B2 (en) 2015-10-28 2024-02-20 Becton, Dickinson And Company Extension tubing strain relief

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