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CN102639162B - Process for production of antimicrobial medical instrument, and antimicrobial medical instrument - Google Patents

Process for production of antimicrobial medical instrument, and antimicrobial medical instrument Download PDF

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Publication number
CN102639162B
CN102639162B CN201180004706.XA CN201180004706A CN102639162B CN 102639162 B CN102639162 B CN 102639162B CN 201180004706 A CN201180004706 A CN 201180004706A CN 102639162 B CN102639162 B CN 102639162B
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China
Prior art keywords
solvent
antibacterial
antibiotic property
medical instrument
antimicrobial
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CN201180004706.XA
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Chinese (zh)
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CN102639162A (en
Inventor
竹村直人
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Terumo Corp
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Terumo Corp
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    • 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
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04Macromolecular materials
    • A61L29/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L29/08Materials for coatings
    • A61L29/10Inorganic materials
    • A61L29/106Inorganic materials other than carbon
    • 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
    • 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
    • A61L2300/622Microcapsules
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Inorganic Chemistry (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

A process for producing an antimicrobial medical instrument, characterized by comprising: an adhesion step of adhering an solvent containing an antimicrobial agent, which is produced by dispersing particles of the antimicrobial agent in a mixed solution comprising a first solvent and a second solvent having different boiling points from each other, onto the surface of at least a part of a medical instrument which is to be inserted into the body; and a drying step of drying the antimicrobial-agent-containing solvent adhered onto the surface of the medical instrument.

Description

The manufacture method of antimicrobial medical instrument and antimicrobial medical instrument
Technical field
The present invention relates to antimicrobial medical instrument manufacture method and according to the antimicrobial medical instrument manufactured by this manufacture method, especially, it is characterized in that, fix antibacterial on the surface of medical apparatus.
Background technology
As one of antimicrobial medical instrument being endowed antibiotic property, central venous catheter can be enumerated.This central venous catheter thrusts portion, by the point Preserving time of central venous catheter in superior vena caval utensil at the skin of subclavian vein or jugular vein insertion central venous catheter.
Further, central venous catheter thrusts portion in order to avoid antibacterial by the skin of central venous catheter or tube chamber enters in body, causes the danger of bacteriological infection, and therefore central venous catheter has been endowed antibiotic property.In addition, due to sometimes by central venous catheter Preserving time in body, therefore wish can maintain antibiotic property for a long time.
, as the manufacture method of antimicrobial medical instrument, such as, have: as disclosed in patent documentation 1 herein, antibacterial is rubbed as the manufacture method in the raw-material macromolecular compound etc. of medical apparatus.
In addition, also have as disclosed in patent document 2, for example, medical apparatus is soaked in and is dissolved with in the solvent of antibacterial, make solvent seasoning simultaneously, by the manufacture method on the surface of antibacterial oxidant layer coated medical utensil.
In addition, according to the manufacture method of above-mentioned antimicrobial medical instrument, when using mutually commensurability antibacterial, compared with when antibacterial to be rubbed in macromolecular compound etc. and manufacture, when the surperficial coated antibacterial oxidant layer of medical apparatus, the surface distributed of medical apparatus has more antibacterial.Therefore, when the surperficial coated antibacterial oxidant layer of medical apparatus, there is the high advantage of antibiotic property.
Prior art document
Patent documentation
Patent documentation 1: Japanese Patent Laid-Open 5-220216 publication
Patent documentation 2: Japanese Patent Laid-Open 11-290449 publication
Summary of the invention
The problem that invention will solve
But, such as use silver zeolite etc. to be insoluble to the antibacterial of solvent, during by the coating of central venous catheter surface, because silver zeolite is insoluble to solvent, so be fixed in the surface of central venous catheter with the state that particle diameter is larger.
Therefore, there is such problem in the middle of using: by central venous catheter insertosome time, the antibacterial oxidant layer friction on central venous catheter surface, antibacterial easily comes off from central vein catheter surface, can not long term maintenance antibiotic property.
Therefore, silver zeolite etc. cannot be used to be insoluble to the antibacterial manufacture of solvent can the antimicrobial medical instrument of long term maintenance antibiotic property in the past.
So in view of the above problems, problem of the present invention is, even provide the antibacterial being insoluble to solvent, also antibacterial can be fixed on the surface of medical apparatus, and the manufacture method of the antimicrobial medical instrument of energy long term maintenance antibiotic property.
Solve the means of problem
In order to solve above-mentioned problem, the feature of the manufacture method of the antimicrobial medical instrument that the present invention relates to is, comprise in the mixed solvent that the 1st solvent that makes boiling point different and the 2nd solvent mix be dispersed with antimicrobial particles at least body being attached to medical apparatus containing antibacterial solvent in insertion portion surface on attachment operation, and order is attached to the above-mentioned drying process containing antibacterial solvent seasoning on above-mentioned medical apparatus surface.
According to the manufacture method of such antimicrobial medical instrument, by attachment operation be attached to medical apparatus surface containing in antibacterial solvent, although containing the 2nd solvent that can dissolve medical apparatus, but owing to being doped with the 1st solvent, the concentration of the 2nd solvent reduces, so the surface of medical apparatus can not be dissolved.
Then, in drying process, start evaporation along with containing the 1st solvent in antibacterial solvent, the concentration of the 2nd solvent raises, and the surface of medical apparatus starts to dissolve.
Then, when the 2nd solvent evaporated away, the solidification of the solution plane of medical apparatus, antibacterial molten (weld, make it bond by the mode of dissolving, fixing) in medical apparatus on the surface.
Therefore, the surface that just can manufacture medical apparatus is coated with the antimicrobial medical instrument of antibacterial oxidant layer.
Further, the antimicrobial medical instrument manufactured according to above-mentioned operation, antibacterial is difficult to come off from medical tool face, can long term maintenance antibiotic property.
In addition, the feature of the manufacture method of the antimicrobial medical instrument that the present invention relates to is, the boiling point of above-mentioned 1st solvent is lower more than 30 DEG C than the boiling point of above-mentioned 2nd solvent.
According to such manufacture method, because the boiling point of the 1st solvent is lower than the 2nd solvent more than 30 DEG C, therefore during the 1st solvent evaporation, the probability of the 2nd solvent evaporation reduces, and reliably can improve the concentration containing the 2nd solvent in antibacterial solvent.
In addition, the feature of the antimicrobial medical instrument manufacture method that the present invention relates to is, above-mentioned 1st solvent can not dissolve the surface of above-mentioned medical apparatus, and above-mentioned 2nd solvent can dissolve the surface of above-mentioned medical apparatus.
Such manufacture method, owing to containing in antibiotic property solvent except the 2nd solvent making the surface dissolution of medical apparatus, also containing the 1st solvent not dissolving medical apparatus surface, therefore reduces containing the concentration of the 2nd solvent in antibiotic property solvent.Therefore, namely order is attached to medical apparatus containing antibiotic property solvent, only otherwise make the 1st solvent evaporation, does not just worry the surface dissolution of medical apparatus.
On the other hand, by making the 1st solvent evaporation, the concentration containing the 2nd solvent in antibacterial solvent can be improved, make the surface dissolution of medical apparatus.
In addition, the feature of the above-mentioned drying process that the present invention relates to is, comprises the 1st treatment process of above-mentioned 1st solvent of room temprature evaporation and the 2nd treatment process of above-mentioned 2nd solvent of heating evaporation.
According to such manufacture method, by the 1st treatment process of room temprature evaporation the 1st solvent, the concentration containing the 2nd solvent in antibacterial solvent can be improved, the surface dissolution of medical apparatus can be made.In addition, the 1st treatment process makes the 1st solvent evaporation under room temperature, therefore do not worry medical apparatus temperature distortion.
In addition, by the 2nd treatment process, the 2nd solvent can evaporate, and therefore by the surface dissolution of medical apparatus, therefore the solution plane of medical apparatus can not can be solidified, make antibacterial molten in the surface of medical apparatus.
In addition, in the manufacture method of the antimicrobial medical instrument that the present invention relates to, above-mentioned antimicrobial particles preferably containing silver-colored nonloaded silica particles, zeolite Argent grain, in Argent grain at least any one.
According to such manufacture method, due to the silver of antibacterial action excellence is used as antibacterial, the more excellent antimicrobial medical instrument of antibacterial action therefore can be manufactured.
In addition, the antimicrobial medical instrument manufacture method that the present invention relates to is preferably above-mentioned is added with dispersant containing in antibacterial solvent.This is due to according to such manufacture method, can seek the dispersibility stabilisation being scattered in the antibacterial in mixed solvent.
In addition, the feature of the antimicrobial medical instrument that the present invention relates to is, is to manufacture according to the tool manufacture method of above-mentioned antibiotic property Medical treatment device.Based on such antimicrobial medical instrument, the surface due to medical apparatus molten have antibacterial, antibacterial difficult drop-off during use, so can long term maintenance antibiotic property.
Invention effect
According to the present invention, even the antibacterial being insoluble to solvent can be provided, also antibacterial can be fixed on the surface of medical apparatus, and the manufacture method of the antimicrobial medical instrument of energy long term maintenance antibiotic property.
Accompanying drawing explanation
The general view that the entirety that [Fig. 1] shows the central venous catheter used in embodiments of the present invention is formed.
[Fig. 2] observes the figure on the surface of the antibiotic property pipe embodiment 1 from vertical direction by scanning electron microscope.
[Fig. 3] is by the figure of scanning electron microscope from the surface of the antibiotic property pipe vertical direction observation and comparison example 2.
[Fig. 4] observes the figure on the surface of antibiotic property pipe after friction embodiment 1 from vertical direction by scanning electron microscope.
[Fig. 5] by scanning electron microscope from the figure on surface of the antibiotic property pipe vertical direction observation and comparison example 2 after friction.
[Fig. 6] reflects the chart of the rheological parameters' change with time of the stripping quantity of the silver ion in the antibiotic property pipe in embodiment 1 and the antibiotic property pipe in comparative example 3.
[Fig. 7] reflects the chart of the rheological parameters' change with time of the antibacterial activity value of the antibiotic property pipe in embodiment 1 and the antibiotic property pipe in comparative example 3.
[Fig. 8] is by the figure of scanning electron microscope from the surface of the antibiotic property pipe oblique observation embodiment 2.
[Fig. 9] is by the figure in the cross section of the antibiotic property pipe in sem observation embodiment 2.
[Figure 10] is by the figure of scanning electron microscope from the surface of the antibiotic property pipe oblique observation and comparison example 4.
[Figure 11] is by the figure in the cross section of the antibiotic property pipe in sem observation comparative example 4.
The explanation of symbol
Detailed description of the invention
Then, be described by the manufacture method of accompanying drawing to the antimicrobial medical instrument in embodiments of the present invention.The manufacture method of the antimicrobial medical instrument of embodiment comprises: order is attached to the attachment operation on medical apparatus surface containing antibacterial solvent, and the drying process containing antibacterial solvent seasoning making medical apparatus adhere on the surface.
(attachment operation)
First illustrate that order is attached to the attachment operation on medical apparatus surface containing antibacterial solvent.
(central venous catheter)
Medical apparatus-the central venous catheter 1 used in embodiment is described.As shown in Figure 1, this central venous catheter 1 possesses: the tubular body portion 2 with the tube chamber (not shown) of the flowing such as medicinal liquid, the point 3 being engaged in the tubulose of the most advanced and sophisticated side of main part 2, be engaged in the catheter interface (hub) 4 of the base end side of main part 2, be engaged in the connection tube 5 injected for medicinal liquid of catheter interface 4, and is engaged in the adapter 6 of base end side of connection tube 5.
This central venous catheter 1 is for being inserted from subclavian vein or jugular vein by main part 2, by point 3 indwelling in superior vena cava etc., carries out the medical apparatus of high calorie transfusion, dispensing, blood sampling etc., formed by polyurethane from connection tube 5.
Moreover in central venous catheter 1, inserting position in the body of medical apparatus is main part 2 and point 3, the surface of inserting position in the body of so-called central venous catheter 1 refers to the main part 2 of tubular and the inner surface of point 3 and outer surface.
In addition, in embodiment, use central venous catheter 1 to be described as medical apparatus, but be also applicable in addition indwelling as long-time in foley catheter (Foley catheter), gastric canal, tube for transfusion, artificial ventilator, wrapping (dressing) material, feeding tube (feeding tube) etc. in human body, the equipment that formed by the macromolecular compound of the thermoplastic resin except metal or thermoplastic resin etc.
(containing antibacterial solvent)
It is the solvent being dispersed with antibacterial in mixed solvent containing antibacterial solvent.In addition, so-called mixed solvent refers to mixing the 1st solvent and the 2nd solvent and the solvent manufactured.
2nd solvent is the solution on the medical apparatus surface of solubilized attachment, is the high boiling solvent that evaporating temperature is higher than aftermentioned 1st solvent.Therefore, can the 2nd solvent dissolve medical apparatus, is relatively to determine according to the raw material forming medical apparatus.
In addition, due in embodiment, central venous catheter 1 is formed by polyurethane, therefore as the 2nd solvent that can dissolve this polyurethane, N-Methyl pyrrolidone (NMP), DMF (DMF), dimethyl acetylamide (DMA), Ketohexamethylene etc. can be enumerated.Boiling point as the 2nd solvent of such high boiling solvent is 100 DEG C ~ 250 DEG C, and evaporating temperature is higher than aftermentioned 1st solvent.
1st solvent is the solvent of the concentration for mixing, reduce the 2nd solvent in mixed solvent with the 2nd solvent, while not dissolving medical apparatus, is at the low boiling point solvent than the 2nd solvent lower temperature evaporation.Such as methanol or ethanol can be enumerated.
In addition, as the boiling point preferably 50 DEG C ~ 100 DEG C of the 1st solvent of such low boiling point solvent, lower more than 30 DEG C than the boiling point of the 2nd solvent as high boiling solvent.
In addition, the mixing ratio of the 2nd solvent and the 1st solvent is the blending ratio not dissolving medical apparatus, and the mixed volume of the 2nd solvent and the 1st solvent is desirable than in the scope of 1: 3 ~ 3: 1.
(antibacterial)
Antibacterial can enumerate the inorganic series antibacterial agent with antibiotic property, even if or dope the organic system antibacterial also not losing antibiotic property in mixed solvent, can enumerate such as, silver-colored nonloaded silica particles, zeolite Argent grain, Argent grain, copper granule, Pt microparticles, titan oxide particles, Zinc oxide particles, tungsten oxide particles, silver sulfadiazine, CNT, silver-colored load CNT, silver bag are by CNT etc.Then, antibacterial is dropped in mixed solvent and stirs, make antibacterial disperse in mixed solvent, manufacture containing antibacterial solvent.
(dispersant)
In addition, in order to seek the stabilisation of the dispersibility of antibacterial in mixed solvent, also dispersant can be added in mixed solvent.Dispersant have be adsorbed in particle surface, suppress electrodynamic repulsion force or sterically hindered cause intergranular coagulation, precipitation effect.The kind of dispersant is the material of molecular skeleton with polyethers system, Polyester, acrylic acid series, urethanes system by classification of chemical structure, is categorized as the material with amine system, carboxylic serials, phosphoric acid system absorption base by adsorption group.Kind according to the antibacterial used or solvent selectes most suitable dispersant.
(attachment)
By central venous catheter being soaked containing in antibacterial solvent, make the surface being attached to central venous catheter containing antibacterial solvent.Except soaking, also have spraying etc., be not particularly limited.In addition, the not only outer surface of central venous catheter, inner surface also must adhere to mixed solvent.
(drying process)
The following describes and will be attached to the drying process carrying out drying containing antibacterial solvent on central venous catheter 1 surface.
The drying process of embodiment is by making the 1st treatment process of the 1st solvent evaporation contained in antibacterial solvent, making the 2nd treatment process of the 2nd solvent evaporation contained in antibacterial solvent and these 3 operations of the 3rd treatment process form.
(the 1st treatment process)
1st treatment process is by room temperature placing 1 hours etc., makes containing the 1st solvent evaporation in antibacterial solvent, for improving the operation of the concentration containing the 2nd solvent in antibacterial solvent.
Therefore, the temperature of the 1st treatment process is not particularly limited, but when for room temperature, the major part of the 1st solvent methanol can be evaporated.
Then, by the 1st treatment process, the concentration containing the 2nd solvent in antibacterial solvent raises, and can make the surface dissolution containing the central venous catheter accompanying by antibacterial solvent, antibacterial is buried.
In addition, the time of the 1st treatment process must be make the surface dissolution of central venous catheter to such degree: the macromolecular material of the central venous catheter of dissolving does not cover whole antibacterial, and namely a part of antibacterial exposes from the macromolecular material dissolved.
(the 2nd treatment process)
2nd treatment process is the operation by heat treatment evaporation the 2nd solvent.In addition, be not particularly limited for the heat treated temperature and time evaporating the 2nd solvent, but should be noted that, if temperature is too high, central venous catheter may be out of shape.
(the 3rd treatment process)
3rd treatment process is to evaporate remaining operation of heat-treating containing antibacterial solvent.Therefore, as long as heat treatment the 2nd solvent evaporated away of the 3rd treatment process, will containing the boiling temperature of antibacterial solvothermal to the 2nd solvent.In addition must be central venous catheter not Yin Gaowen and the degree of being out of shape.
Like this, the macromolecular material of the formation central venous catheter of dissolving solidification, a part of antibacterial is molten, and a part of antibacterial is fixed in the surface of central venous catheter with the state exposed.
Above the manufacture method of the antimicrobial medical instrument in embodiment is illustrated, according to the manufacture method of embodiment, a part antibacterial using the form exposed molten in the surface of the central venous catheter as medical apparatus, the central venous catheter that surface is fixed with antibacterial can be manufactured.
Although be illustrated the manufacture method of the antimicrobial medical instrument in embodiment above, the present invention is not limited to the manufacture method illustrated in embodiment.
Embodiment
Below, embodiments of the invention etc. are described.
In embodiment 1, manufacture antibiotic property pipe A according to the manufacture method that illustrates in above-mentioned embodiment, whether molten the antibacterial in the surface of antibiotic property pipe A is easily come off and carries out disbonded test.In addition, owing to employing the 2nd solvent dissolving medical apparatus, the confirmation of the shape whether antibiotic property pipe A is out of shape therefore also is carried out in the lump.
In addition, as comparative example, prepare the solvent different from mixed solvent of the present invention, prepare the comparative example 1,2 manufactured by this mixed solvent simultaneously, carry out the disbonded test of test that whether medical apparatus be out of shape and antibacterial in the lump.
(embodiment 1)
Embodiment 1 uses polyurethane tube as medical apparatus.This polyurethane tube for raw material, is formed as external diameter 2.1mm, the thing of internal diameter 1.3mm with polyurethane (manufacture of Japanese ミ ラ クトラン society, trade name " E990 ").
2nd solvent prepares N-Methyl pyrrolidone 5mL, and on the other hand, the 1st solvent prepares methanol 5mL, and both are mixed obtained mixed solution.Moreover the mixing ratio of the 2nd solvent and the 1st solvent is 1: 1.
In addition, antibacterial prepares zeolite Argent grain, and (シ Na ネ Application ゼ オ ミ ツク society manufactures, trade name " zeolite silver AJ-10D ") powder 0.3g, be scattered in mixed solvent, obtained add the zeolite Argent grain having 3wt/v% ratio containing antibacterial solvent orange 2 A.In addition, the silver content of this zeolite Argent grain is 5%.
Then, adherence method is, is soaked in by the polyurethane tube of long 30cm containing making it attachment in antibacterial solvent orange 2 A.
Drying process is, as the 1st treatment process, place 1 hour under room temperature (20 DEG C), as the 2nd treatment process, heat treatment 1 hour in the baking oven of 50 DEG C, as the 3rd treatment process, the temperature of baking oven is brought up to 80 DEG C of dryings 2 hours, thus manufacture molten the antibiotic property pipe A having anti-biotic material in surface.In addition, by containing antibacterial solvent orange 2 A coat pipe A after weight add 0.0342g.
(comparative example 1,2)
Comparative example 1 and the antimicrobial medical instrument of comparative example 2 are by the solvent different from the mixed solvent of embodiment 1-containing antibacterial solvent B or obtained containing antibacterial solvent C.
Particularly, the mixed solvent B of comparative example 1 is only made up of the 2nd solvent, prepares N-Methyl pyrrolidone 10mL.
Then, in this mixed solvent B, prepare zeolite Argent grain (シ Na ネ Application ゼ オ ミ ツク society manufacture similarly to Example 1, trade name " zeolite silver AJ-10D ") powder 0.3g, disperse in mixed solvent B, obtained add the zeolite Argent grain having 3wt/v% ratio containing antibacterial solvent B.Then, via the drying process identical with embodiment 1, manufacture antibiotic property pipe B.
In addition, the mixed solvent C of comparative example 2 is only made up of the 1st solvent, prepares methanol 10mL.Then, in this mixed solvent C, prepare zeolite Argent grain (シ Na ネ Application ゼ オ ミ ツク society manufacture similarly to Example 1, trade name " zeolite silver AJ-10D ") powder 0.3g, be separated in mixed solvent C, obtained add the zeolite Argent grain having 3wt/v% ratio containing antibacterial solvent C.Then, via the drying process identical with embodiment 1, manufacture antibiotic property pipe C.
(shape after manufacture confirms)
The antibiotic property pipe C shape separately of the antibiotic property pipe A of the embodiment 1 manufactured according to above manufacture method by visual confirmation, the antibiotic property pipe B of comparative example 1 and comparative example 2.In addition, the result of shape confirmation as described in Table 1.
[table 1]
Antibiotic property pipe The change of pipe base material Coating stripping
Embodiment 1 Constant Unstripped
Comparative example 1 Distortion Unstripped
Comparative example 2 Constant Peel off
It is that shape confirms as a result, the shape of pipe of antibiotic property pipe A and antibiotic property pipe C does not change.But, the shape distortion of the pipe self of antibiotic property pipe B.That is, the mixed solvent B be only made up of the 2nd solvent, due to the surface of excessive dissolution medical apparatus, therefore the shape of medical apparatus itself there occurs change.
(disbonded test)
The disbonded test of antibacterial is, by scanning electron microscope, (Co., Ltd. Hitachi Ha イ テ Network ノ ロ ジ mono-ズ manufactures, style: S-3400N) surface picture (photography direction: be vertical direction relative to tube-surface, multiplying power: 3000 times), visual confirm the surface of the antibiotic property pipe A after manufacturing, antibiotic property pipe C molten antibacterial whether also molten in the surface of antibiotic property pipe A, antibiotic property pipe C after rubbing through swab stick.Moreover, the power of swab stick friction be with by central venous catheter insertosome time the pipe power that is subject to equal power.In addition, in surface picture (Fig. 2 ~ Fig. 5), antibacterial is taken as granular.
First, can confirm manufacture after antibiotic property pipe A as shown in Figure 2, a part of antibacterial with the state exposed molten in the surface of antibiotic property pipe A.
On the other hand, antibiotic property pipe C also as shown in Figure 3, can confirm that there is antibacterial on the surface of antibiotic property pipe C.
Then, with the surface of swab stick friction antibiotic property pipe A and antibiotic property pipe C.
Based on this, the surface of the antibiotic property pipe A after friction as shown in Figure 4, is still fixed wtih antibacterial, can confirm that antibacterial not easily comes off from the surface of antibiotic property pipe A.On the other hand, as shown in Figure 5, the surface of the antibiotic property pipe C after friction does not have antibacterial, and antibacterial easily comes off.
Moreover antibiotic property pipe B does not carry out disbonded test, but the meltage of tube-surface is many, antibacterial is molten with the state buried.
Therefore, although antibacterial is not peeled off, because antibacterial does not expose, so silver ion can not stripping, known antibiotic property pipe B can not play antibiotic property.
By the result of the test of the antibiotic property pipe A of above embodiment 1, the antibiotic property pipe C of comparative example 2, can prove that the antibacterial of the antibiotic property pipe A of embodiment 1 is not easily peeled off.
Then, stripping quantity and the antibacterial activity value of the silver ion of the antibiotic property pipe A of embodiment 1 is measured.In addition, as comparative example 3, prepare, by rubbing the antibiotic property pipe D manufactured into mode, to measure stripping quantity and the antibacterial activity value of its silver ion.
(comparative example 3)
The raw material of the antibiotic property pipe D of comparative example 3 is the polyurethane (Japanese ミ ラ クトラン society manufacture, trade name " E990 ") identical with embodiment 1.
In addition, antibacterial also prepares the powder of zeolite Argent grain similarly to Example 1.Then, in the ratio mixed zeolite Argent grain relative to polyurethane 5wt/v%, manufacture the antibiotic property pipe D of external diameter 2.1mm, internal diameter 1.3mm.And zeolite Argent grain contained in antibiotic property pipe D is 0.0348g, and the amount of its antibacterial had is roughly the same with the 0.0342g of antibiotic property pipe A.
(test method)
Test method is, antibiotic property pipe A and antibiotic property pipe D is cut into length 30cm, and (total surface area is 32 ± 5cm 2left and right), be soaked in staphylococcus aureus suspension culture based sols 10mL.Then, use the solution after soaking, measure the stripping quantity (ppm) of silver ion with ICP emission spectrographic analysis device.In addition, by measuring the stripping quantity of the silver ion of immersion after 1 day, after 7 days, after 14 days, after 21 days, after 28 days in the solution respectively, the rheological parameters' change with time of silver ion stripping quantity is measured.Measurement result is as shown in table 6.
On the other hand, to antibacterial activity value, use the solution soaking antibiotic property pipe A, antibiotic property pipe D, measure according to vibration (shake) method specified in antibacterial tests technical protocol meeting specification.In addition, by measuring the antibacterial activity value of immersion after 0 day, after 7 days, after 14 days, after 21 days, after 28 days in the solution respectively, the rheological parameters' change with time of antibacterial activity value is measured.Measurement result is as shown in table 7.
About the mensuration of silver ion stripping quantity, although the antibiotic property pipe D of the antibiotic property pipe A of embodiment 1 and comparative example 3 as time goes by, the stripping quantity of silver ion all reduces, and the antibiotic property pipe A of embodiment 1 is more than the silver ion stripping quantity of the antibiotic property pipe D of comparative example 3.
In addition, about antibacterial activity value, the antibacterial activity value of the antibiotic property pipe A of embodiment 1 does not decline, and maintains higher value.That is, based on more than, the antibiotic property pipe A of embodiment 1 can play antibiotic property for a long time.
On the other hand, the antibiotic property pipe D of comparative example 3 is until show the antibacterial activity value equal with embodiment 1 after 14 days, but after 21 days, after 28 days, antibacterial activity value reduces.
Therefore, can prove that the antibiotic property pipe A of embodiment 1 is compared with the antibiotic property pipe D of comparative example 3, the antibacterial activity value that long-term performance is higher.
Then, reaffirm antibiotic property tube-surface the state of molten antibacterial.
(embodiment 2, comparative example 4)
Embodiment 2 manufactures antibiotic property pipe E similarly to Example 1.In addition, comparative example 4 manufactures antibiotic property pipe F in the same manner as comparative example 2.
To the antibiotic property pipe E, the antibiotic property pipe F that manufacture, by the surface picture of scanning electron microscope (Co., Ltd. Hitachi Ha イ テ Network ノ ロ ジ mono-ズ manufacture, style: S-3400N) (photography direction: be oblique relative to tube-surface, multiplying power: 3000 times), cross-section photograph (multiplying power: 3000 times), its surface of visual confirmation the state of molten antibacterial.Moreover in surface picture (Fig. 8, Figure 10), cross-section photograph (Fig. 9, Figure 11), antibacterial is taken as granular.
The antibiotic property pipe E of embodiment 2 can be confirmed as shown in Figure 8, Figure 9, a part of antibacterial with the state exposed molten in the surface of antibiotic property pipe E.It can thus be appreciated that, antibiotic property pipe E in above-mentioned disbonded test, antibacterial difficult drop-off.
In addition, the antibiotic property pipe F of comparative example 4 as shown in Figure 10, Figure 11, can confirm that there is antibacterial on the surface of antibiotic property pipe F.It can thus be appreciated that antibiotic property pipe F is in above-mentioned disbonded test, and antibacterial easily comes off.

Claims (5)

1. a manufacture method for antimicrobial medical instrument, is characterized in that, comprises
Insert the attachment operation on the surface at position at least body that order is attached to medical apparatus containing antibacterial solvent, should containing antibacterial solvent be disperse antimicrobial particles to form in the mixed solvent mixed at the 1st different solvent of boiling point and the 2nd solvent and
Order is attached to the described drying process containing antibacterial solvent seasoning on described medical apparatus surface,
The boiling point of described 1st solvent is lower more than 30 DEG C than the boiling point of described 2nd solvent,
Described 1st solvent is the solvent on the surface can not dissolving described medical apparatus,
Described 2nd solvent can dissolve the surface of described medical apparatus.
2. the manufacture method of antimicrobial medical instrument as claimed in claim 1, is characterized in that, described drying process comprises the 2nd treatment process of the 2nd solvent described in the 1st treatment process of the 1st solvent described in room temprature evaporation and heating evaporation.
3. the manufacture method of antimicrobial medical instrument as claimed in claim 1, is characterized in that, described antimicrobial particles contain in silver-colored nonloaded silica particles, zeolite Argent grain, Argent grain at least any one.
4. the manufacture method of antimicrobial medical instrument as claimed in claim 1, is characterized in that, the described antibacterial solvent that contains is added with dispersant.
5. an antimicrobial medical instrument, is characterized in that, according to claim 1 to claim 4 any one described in the manufacture method manufacture of antimicrobial medical instrument.
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