CN102639162A - 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 PDFInfo
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- CN102639162A CN102639162A CN201180004706XA CN201180004706A CN102639162A CN 102639162 A CN102639162 A CN 102639162A CN 201180004706X A CN201180004706X A CN 201180004706XA CN 201180004706 A CN201180004706 A CN 201180004706A CN 102639162 A CN102639162 A CN 102639162A
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- solvent
- antibiotic property
- antibacterial
- medical apparatus
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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
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- 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
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- 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
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
Technical field
The present invention relates to the manufacturing approach of antibiotic property medical apparatus and, especially, it is characterized in that, fixing antibacterial on the surface of medical apparatus according to the antibiotic property medical apparatus of this manufacturing approach manufacturing.
Background technology
As being endowed one of antibiotic property medical apparatus of antibiotic property, can enumerate central venous catheter.This central venous catheter is to thrust portion at the skin that subclavian vein or jugular vein insert central venous catheter, and the point of central venous catheter is kept somewhere in superior vena caval utensil for a long time.
And central venous catheter is thrust in portion or the tube chamber entering body, is caused risk of bacterial infections for fear of the skin of antibacterial through central venous catheter, so central venous catheter has been endowed antibiotic property.In addition, owing to sometimes central venous catheter is kept somewhere for a long time in body, therefore hope to keep antibiotic property for a long time.
Here, the manufacturing approach as the antibiotic property medical apparatus for example has: as disclosed in the patent documentation 1, antibacterial is rubbed the manufacturing approach in raw-material macromolecular compound as medical apparatus etc.
In addition,, medical apparatus is soaked in the solvent that is dissolved with antibacterial, makes solvent seasoning simultaneously, be coated with the manufacturing approach on the surface of medical apparatus with the antibacterial layer also just like disclosed in the patent documentation 2.
In addition; According to the manufacturing approach of above-mentioned antibiotic property medical apparatus, when using the antibacterial of same amount, with antibacterial is rubbed macromolecular compound etc. in and compare when making; In the surface coated antibacterial layer of medical apparatus, the surface distributed of medical apparatus has more antibacterial.Therefore, in the surface coated antibacterial layer of medical apparatus, has the high advantage of antibiotic property.
The prior art document
Patent documentation
Patent documentation 1: japanese patent laid-open 5-220216 communique
Patent documentation 2: japanese patent laid-open 11-290449 communique
Summary of the invention
The problem that invention will solve
Yet, for example use silver zeolite etc. to be insoluble to the antibacterial of solvent, during with the central venous catheter surface coated, because silver zeolite is insoluble to solvent, so be fixed in the surface of central venous catheter with the bigger state of size ratio.
Therefore, there is such problem in the middle of the use: when inserting central venous catheter in the body, the antibacterial layer friction on central venous catheter surface, antibacterial comes off from the central vein catheter surface easily, can not the long term maintenance antibiotic property.
Therefore, can't use silver zeolite etc. to be insoluble to the antibiotic property medical apparatus that the antibacterial manufacturing of solvent can the long term maintenance antibiotic property in the past.
So in view of the above problems, problem of the present invention is, even the antibacterial that is insoluble to solvent is provided, also can antibacterial be fixed in the surface of medical apparatus, and the manufacturing approach of antibiotic property medical apparatus that can the long term maintenance antibiotic property.
Solve the means of problem
In order to solve above-mentioned problem; The manufacturing approach of the antibiotic property medical apparatus that the present invention relates to is characterised in that; Comprise be dispersed with in the mixed solvent that makes the 1st different solvent of boiling point and the 2nd solvent form antimicrobial particles contain that the antibacterial solvent is attached to insertion portion in the body at least of medical apparatus lip-deeply adhere to the above-mentioned drying process that contains the antibacterial solvent seasoning that operation and order are attached to above-mentioned medical apparatus surface.
Manufacturing approach according to such antibiotic property medical apparatus; Be attached to containing in the antibacterial solvent of medical apparatus surface through adhering to operation; Though contain the 2nd solvent that can dissolve medical apparatus; But the 1st solvent owing to mixed, the concentration of the 2nd solvent reduces, so the surface of medical apparatus can not dissolved.
Then, in the drying process, along with the 1st solvent start vaporizer that contains in the antibacterial solvent, the concentration of the 2nd solvent raises, and the surface of medical apparatus begins dissolving.
Then, when the 2nd solvent evaporation was fallen, the solution plane of medical apparatus solidified, and antibacterial is dissolving (weld, make through dissolved mode it is bonding, fixing) on the medical apparatus surface.
Therefore, just can make the antibiotic property medical apparatus that is coated with the antibacterial layer on the surface of medical apparatus.
And according to the antibiotic property medical apparatus that above-mentioned operation is made, antibacterial is difficult to come off from the medical apparatus surface, can the long term maintenance antibiotic property.
In addition, the manufacturing approach of the antibiotic property medical apparatus that the present invention relates to is characterised in that the boiling point of above-mentioned the 1st solvent is lower more than 30 ℃ than the boiling point of above-mentioned the 2nd solvent.
According to such manufacturing approach, because the boiling point of the 1st solvent is low more than 30 ℃ than the 2nd solvent, so during the 1st solvent evaporation, the probability minimizing of the 2nd solvent evaporation can improve the concentration that contains the 2nd solvent in the antibacterial solvent reliably.
In addition, the antibiotic property medical apparatus manufacturing approach that the present invention relates to is characterised in that above-mentioned the 1st solvent can not dissolve the surface of above-mentioned medical apparatus, and above-mentioned the 2nd solvent can dissolve the surface of above-mentioned medical apparatus.
Such manufacturing approach owing to contain in the antibiotic property solvent except the 2nd solvent of the surface dissolution that makes medical apparatus, also contains the 1st solvent that does not dissolve the medical apparatus surface, so contain the concentration reduction of the 2nd solvent in the antibiotic property solvent.Therefore, promptly order contains the antibiotic property solvent and is attached to medical apparatus, only otherwise make the 1st solvent evaporation, does not just worry the surface dissolution of medical apparatus.
On the other hand,, can improve the concentration that contains the 2nd solvent in the antibacterial solvent, make the surface dissolution of medical apparatus through making the 1st solvent evaporation.
In addition, the above-mentioned drying process that the present invention relates to is characterised in that, comprises that room temperature evaporates the 1st treatment process of above-mentioned the 1st solvent and the 2nd treatment process of above-mentioned the 2nd solvent of heating evaporation.
According to such manufacturing approach, through the 1st treatment process that room temperature is evaporated the 1st solvent, can improve the concentration that contains the 2nd solvent in the antibacterial solvent, can make the surface dissolution of medical apparatus.In addition, the 1st treatment process is to make the 1st solvent evaporation under the room temperature, does not therefore worry the medical apparatus temperature distortion.
In addition, through the 2nd treatment process, the 2nd solvent can evaporate, and therefore can therefore the surface dissolution of medical apparatus can not solidified the solution plane of medical apparatus, makes antibacterial dissolve the surface in medical apparatus.
In addition, in the manufacturing approach of the antibiotic property medical apparatus that the present invention relates to, above-mentioned antimicrobial particles preferably contain in silver-colored load silica dioxide granule, zeolite silver granule, the silver-colored granule at least any.
According to such manufacturing approach, because the silver that antibacterial action is excellent, therefore can be made the excellent more antibiotic property medical apparatus of antibacterial action as antibacterial.
In addition, the antibiotic property medical apparatus manufacturing approach that the present invention relates to is added with dispersant preferred above-mentioned containing in the antibacterial solvent.This is owing to according to such manufacturing approach, can seek to be scattered in the dispersibility stabilisation of the antibacterial in the mixed solvent.
In addition, the antibiotic property medical apparatus that the present invention relates to is characterised in that, is to make according to the tool manufacturing approach of above-mentioned antibiotic property medical treatment device.Based on such antibiotic property medical apparatus, because is dissolving on the surface of medical apparatus antibacterial is arranged, so antibacterial difficult drop-off during use is can the long term maintenance antibiotic property.
The invention effect
According to the present invention, even the antibacterial that is insoluble to solvent can be provided, also can antibacterial be fixed in the surface of medical apparatus, and the manufacturing approach of the antibiotic property medical apparatus of ability long term maintenance antibiotic property.
Description of drawings
[Fig. 1] shows the general view that the integral body of the central venous catheter of using in the embodiment of the present invention constitutes.
[Fig. 2] is through the figure on the surface of the antibiotic property pipe of scanning electron microscope from vertical direction observation embodiment 1.
[Fig. 3] is through the figure on the surface of the antibiotic property pipe of scanning electron microscope from vertical direction observation comparative example 2.
[Fig. 4] is through the figure on antibiotic property pipe the surface through friction after of scanning electron microscope from vertical direction observation embodiment 1.
[Fig. 5] is through the figure on antibiotic property pipe the surface through friction after of scanning electron microscope from vertical direction observation comparative example 2.
The stripping quantity of the antibiotic property pipe of [Fig. 6] reflection among the embodiment 1 and the silver ion in the antibiotic property pipe in the comparative example 3 through the time variation chart.
The antibacterial activity value of the antibiotic property pipe of [Fig. 7] reflection among the embodiment 1 and the antibiotic property pipe in the comparative example 3 through the time variation chart.
[Fig. 8] is through the figure on the surface of the antibiotic property pipe of scanning electron microscope from oblique observation embodiment 2.
[Fig. 9] is through the figure in the cross section of the antibiotic property pipe among the sem observation embodiment 2.
[Figure 10] is through the figure on the surface of the antibiotic property pipe of scanning electron microscope from oblique observation comparative example 4.
[Figure 11] is through the figure in the cross section of the antibiotic property pipe in the sem observation comparative example 4.
The explanation of symbol
The specific embodiment
Then, describe with the manufacturing approach of accompanying drawing the antibiotic property medical apparatus in the embodiment of the present invention.The manufacturing approach of the antibiotic property medical apparatus of embodiment comprises: order contains the antibacterial solvent and is attached to adhering to operation and making the drying process that contains the antibacterial solvent seasoning that adheres on the medical apparatus surface of medical apparatus surface.
(adhering to operation)
At first the explanation order contains the operation of adhering to that the antibacterial solvent is attached to the medical apparatus surface.
(central venous catheter)
Medical apparatus-central venous catheter 1 to using in the embodiment describes.As shown in Figure 1; This central venous catheter 1 possesses: have mobile tube chambers (not shown) such as medicinal liquid tubular body portion 2, be engaged in the most advanced and sophisticated side of main part 2 piped point 3, be engaged in the base end side of main part 2 catheter interface (hub) 4, be engaged in the connection tube 5 that medicinal liquid injects that is used for of catheter interface 4 and the adapter 6 that is engaged in the base end side of connection tube 5.
This central venous catheter 1 is to be used for main part 2 is inserted from subclavian vein or jugular vein, and point 3 is kept somewhere in superior vena cava etc., and the medical apparatus from connection tube 5 carries out high calorie transfusion, dispensing, blood sampling etc. is formed by polyurethane.
Moreover in central venous catheter 1, inserting the position in the body of medical apparatus is main part 2 and point 3, and the surface of inserting the position in the body of so-called central venous catheter 1 is meant the inner surface and the outer surface of cylindrical main body portion 2 and point 3.
In addition; In the embodiment; Use central venous catheter 1 to describe as medical apparatus, but in addition also applicable to keeping somewhere for a long time like foley catheter (Foley catheter), gastric canal, tube for transfusion, artificial ventilator, wrapping (dressing) material, feeding tube (feeding tube) etc. in equipment human body, that form by the macromolecular compound of thermoplastic resin except that metal or thermoplastic resin etc.
(containing the antibacterial solvent)
Containing the antibacterial solvent is the solvent that is dispersed with antibacterial in the mixed solvent.In addition, so-called mixed solvent is meant the solvent that mixes the 1st solvent and the 2nd solvent and make.
The 2nd solvent is the surperficial solution of medical apparatus that solubilized is adhered to, and is that evaporating temperature than then is stated the high high boiling solvent of the 1st solvent.Therefore, can the 2nd solvent dissolve medical apparatus, is to determine relatively according to the raw material that constitutes medical apparatus.
In addition; Because in the embodiment, central venous catheter 1 is formed by polyurethane, and therefore conduct can be dissolved the 2nd solvent of this polyurethane; Can enumerate N-Methyl pyrrolidone (NMP), N, dinethylformamide (DMF), dimethyl acetylamide (DMA), Ketohexamethylene etc.Boiling point as the 2nd solvent of such high boiling solvent is 100 ℃～250 ℃, evaporating temperature than after to state the 1st solvent high.
The 1st solvent is to be used for the 2nd solvent, to reduce the solvent of concentration of the 2nd solvent of mixed solvent, when not dissolving medical apparatus, is than the 2nd solvent low boiling point solvent of low temperature evaporation more.Can enumerate for example methanol or ethanol.
In addition, as preferred 50 ℃～100 ℃ of the boiling point of the 1st solvent of such low boiling point solvent, liken to into the boiling point of the 2nd solvent of high boiling solvent low more than 30 ℃.
In addition, the mixing ratio of the 2nd solvent and the 1st solvent is the blending ratio that does not dissolve medical apparatus, and the mixed volume of the 2nd solvent and the 1st solvent is ideal than in 1: 3～3: 1 scope.
(antibacterial)
Antibacterial can be enumerated the inorganic series antibacterial agent with antibiotic property; Even or dope the organic system antibacterial that does not also lose antibiotic property in the mixed solvent; For example can enumerate, silver-colored load silica dioxide granule, zeolite silver granule, silver-colored granule, copper granule, platinum microgranule, titan oxide particles, Zinc oxide particles, tungsten oxide granule, silver sulfadiazine, CNT, silver-colored load CNT, silver encapsulate CNT etc.Then, antibacterial dropped in the mixed solvent stir, make antibacterial in mixed solvent, disperse, make and contain the antibacterial solvent.
(dispersant)
In addition, in order to seek the stabilisation of the dispersibility of antibacterial in the mixed solvent, also can in mixed solvent, add dispersant.Dispersant has particle surface, inhibition electrodynamic repulsion force or the sterically hindered intergranular coagulation that causes, the sedimentary effect of being adsorbed in.The kind of dispersant be categorized as by chemical constitution have polyethers system, the material of the molecular skeleton of polyester system, acrylic acid series, urethanes system, be categorized as by adsorption group have amine system, the material of carboxylic acid system, phosphoric acid system absorption base.According to antibacterial that uses or the selected only dispersant of solvent types.
(adhering to)
Contain the surface that the antibacterial solvent is attached to central venous catheter through central venous catheter being soaked, making in containing the antibacterial solvent.Except soaking, also has spraying etc., not special the qualification.In addition, the outer surface of central venous catheter not only, inner surface also must adhere to mixed solvent.
(drying process)
Explain that below the antibacterial solvent that contains that will be attached to central venous catheter 1 surface carries out exsiccant drying process.
The drying process of embodiment is by making the 1st treatment process that contains the 1st solvent evaporation in the antibacterial solvent, the 2nd treatment process and these 3 operations of the 3rd treatment process of containing the 2nd solvent evaporation in the antibacterial solvent being formed.
(the 1st treatment process)
The 1st treatment process is through at room temperature placing about 1 hour etc., make the 1st solvent evaporation that contains in the antibacterial solvent, being used for improving the operation of the concentration of the 2nd solvent that contains the antibacterial solvent.
Therefore, the temperature of the 1st treatment process is not special to be limited, but when for room temperature, can be with the major part evaporation of the 1st solvent methanol.
Then, through the 1st treatment process, the concentration that contains the 2nd solvent in the antibacterial solvent raises, and can make the surface dissolution that contains the central venous catheter that the antibacterial solvent adhered to, and antibacterial is buried.
In addition, the time of the 1st treatment process must be the surface dissolution that makes central venous catheter to such degree: the macromolecular material of dissolved central venous catheter does not cover whole antibacterial, and promptly a part of antibacterial exposes from dissolved macromolecular material.
(the 2nd treatment process)
The 2nd treatment process is the operation of evaporating the 2nd solvent through heat treatment.In addition, be used to evaporate not special qualification of heat treated temperature and time of the 2nd solvent, but note that if temperature is too high, central venous catheter may be out of shape.
(the 3rd treatment process)
The 3rd treatment process is in order to evaporate the remaining operation that contains the antibacterial solvent and heat-treat.Therefore, the heat treatment of the 3rd treatment process will not contain the boiling temperature that the antibacterial solvent is heated to the 2nd solvent as long as the 2nd solvent evaporation is fallen.Must be not Yin Gaowen and the degree of being out of shape of central venous catheter in addition.
Like this, the macromolecular material of dissolved formation central venous catheter solidifies, and a part of antibacterial is dissolving, and a part of antibacterial is fixed in the surface of central venous catheter with the state that exposes.
More than the manufacturing approach of the antibiotic property medical apparatus in the embodiment is illustrated; Manufacturing approach according to embodiment; Part antibacterial is dissolving in the surface as the central venous catheter of medical apparatus with the form of exposing, and can make the central venous catheter that the surface is fixed with antibacterial.
Though more than the manufacturing approach of the antibiotic property medical apparatus in the embodiment is illustrated the manufacturing approach that the present invention is not limited to explain in the embodiment.
Embodiment
Below, embodiments of the invention etc. are described.
Among the embodiment 1, make antibiotic property pipe A, carry out disbonded test dissolving whether to come off easily in the antibacterial on the surface of antibiotic property pipe A according to the manufacturing approach explained in the above-mentioned embodiment.In addition, owing to used the 2nd solvent of dissolving medical apparatus, therefore also carry out the affirmation of the shape whether antibiotic property pipe A be out of shape in the lump.
In addition,, prepare the solvent different, prepare the comparative example 1,2 made by this mixed solvent simultaneously, carry out the test that whether medical apparatus be out of shape and the disbonded test of antibacterial in the lump with mixed solvent of the present invention as comparative example.
(embodiment 1)
Embodiment 1 uses polyurethane tube as medical apparatus.This polyurethane tube is to be raw material, to form external diameter 2.1mm, the thing of internal diameter 1.3mm with polyurethane (Japanese ミ ラ Network ト ラ Application society makes, trade name " E990 ").
The 2nd solvent is prepared N-Methyl pyrrolidone 5mL, and on the other hand, the 1st solvent is prepared methanol 5mL, with both mixed mixed solutions that gets.Moreover the mixing ratio of the 2nd solvent and the 1st solvent is 1: 1.
In addition, antibacterial is prepared the powder 0.3g of zeolite silver granule (シ Na ネ Application ゼ オ ミ Star Network society makes, trade name " zeolite silver AJ-10D "), is scattered in the mixed solvent, makes to add the particulate antibacterial solvent orange 2 A that contains of zeolite silver that the 3wt/v% ratio is arranged.In addition, the particulate silver content of this zeolite silver is 5%.
Then, adherence method is, the polyurethane tube of long 30cm is soaked in to contain in the antibacterial solvent orange 2 A make it to adhere to.
Drying process is; As the 1st treatment process, room temperature (20 ℃) held 1 hour, as the 2nd treatment process; Heat treatment is 1 hour in 50 ℃ baking oven; As the 3rd treatment process, temperature of oven is brought up to 80 ℃ of dryings 2 hours, thereby make surperficial dissolving the antibiotic property of anti-biotic material pipe A is arranged.In addition, will contain the antibacterial solvent orange 2 A coats the weight of pipe behind the A and has increased 0.0342g.
(comparative example 1,2)
The antibiotic property medical apparatus of comparative example 1 and comparative example 2 is to be made by the solvent different with the mixed solvent of embodiment 1-contain antibacterial solvent B or contain the antibacterial solvent C.
Particularly, the mixed solvent B of comparative example 1 only is made up of the 2nd solvent, prepares N-Methyl pyrrolidone 10mL.
Then; Among this mixed solvent B, prepare powder 0.3g with the same zeolite silver granule (シ Na ネ Application ゼ オ ミ Star Network society makes, trade name " zeolite silver AJ-10D ") of embodiment 1; In mixed solvent B, disperse, make the particulate antibacterial solvent B that contains of zeolite silver that adding has the 3wt/v% ratio.Then, via the drying process identical, make antibiotic property pipe B with embodiment 1.
In addition, the mixed solvent C of comparative example 2 only is made up of the 1st solvent, prepares methanol 10mL.Then; In this mixed solvent C, prepare powder 0.3g with the same zeolite silver granule (シ Na ネ Application ゼ オ ミ Star Network society makes, trade name " zeolite silver AJ-10D ") of embodiment 1; In mixed solvent C, separate, make the particulate antibacterial solvent C that contains of zeolite silver that adding has the 3wt/v% ratio.Then, via the drying process identical, make antibiotic property pipe C with embodiment 1.
(shape after the manufacturing is confirmed)
Through antibiotic property pipe A, the antibiotic property pipe B of comparative example 1 and antibiotic property pipe C separately the shape of comparative example 2 of Visual Confirmation according to the embodiment 1 of above manufacturing approach manufacturing.In addition, the result of shape affirmation is shown in below table 1.
[table 1]
| The antibiotic property pipe | The variation of pipe base material | Coating stripping |
| Embodiment 1 | Constant | Unstripped |
| Comparative example 1 | Distortion | Unstripped |
| Comparative example 2 | Constant | Peel off |
The result that shape is confirmed is that the shape of the pipe of antibiotic property pipe A and antibiotic property pipe C does not change.Yet, the warpage of the pipe self of antibiotic property pipe B.That is, the mixed solvent B that only constitutes by the 2nd solvent, because the surface of excessive dissolution medical apparatus, so variation has taken place in the shape of medical apparatus itself.
(disbonded test)
The disbonded test of antibacterial is; (the Ha イ テ of Co., Ltd. Hitachi Network ノ ロ ジ one ズ makes through scanning electron microscope; Style: (photography direction: with respect to tube-surface is vertical direction to surface picture S-3400N); Multiplying power: 3000 times), whether the antibacterial that dissolving of the surface of the antibiotic property pipe A after the Visual Confirmation manufacturing, antibiotic property pipe C is also dissolving in the surface of antibiotic property pipe A, antibiotic property pipe C after cotton rod friction.Moreover the power of cotton rod friction is the equal power of power that pipe receives when inserting central venous catheter in the body.In addition, (among Fig. 2～Fig. 5), antibacterial is taken to granular surface picture.
At first, the antibiotic property pipe A after can confirming to make is as shown in Figure 2, and a part of antibacterial is dissolving in the surface of antibiotic property pipe A with the state that exposes.
On the other hand, antibiotic property pipe C is also as shown in Figure 3, can confirm that there is antibacterial on the surface of antibiotic property pipe C.
Then, use the surface of cotton rod friction antibiotic property pipe A and antibiotic property pipe C.
Based on this, the antibiotic property pipe A's after the friction is surperficial as shown in Figure 4, is still fixing antibacterial, can confirm that antibacterial is difficult for coming 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 the friction does not have antibacterial, and antibacterial comes off easily.
Moreover antibiotic property pipe B does not carry out disbonded test, but the meltage of tube-surface is many, and antibacterial is dissolving with the state that buries.
Therefore, although antibacterial is not peeled off,,, can know that antibiotic property pipe B can not bring into play antibiotic property so silver ion can not stripping because antibacterial do not expose.
The result of the test of antibiotic property pipe A through 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 difficult for peeling off.
Then, the stripping quantity and the antibacterial activity value of the silver ion of the antibiotic property pipe A of mensuration embodiment 1.In addition, as comparative example 3, prepare to measure the stripping quantity and the antibacterial activity value of its silver ion through rubbing the antibiotic property pipe D that makes into mode.
(comparative example 3)
The raw material of the antibiotic property pipe D of comparative example 3 is the polyurethane identical with embodiment 1 (Japanese ミ ラ Network ト ラ Application society make trade name " E990 ").
In addition, antibacterial is also likewise prepared the particulate powder of zeolite silver with embodiment 1.Then, by mixed zeolite silver granule, make the antibiotic property pipe D of external diameter 2.1mm, internal diameter 1.3mm with respect to polyurethane 5wt/v%.And zeolite silver granule contained among the antibiotic property pipe D is 0.0348g, and the 0.0342g of the amount of the antibacterial that it had and antibiotic property pipe A is roughly the same.
(test method)
Test method is, antibiotic property pipe A and antibiotic property pipe D are cut into length 30cm, and (total surface area is 32 ± 5cm
2About), be soaked among the 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, soak after 1 day through being determined at respectively in the solution, the stripping quantity of the silver ion after 7 days, after 14 days, after 21 days, after 28 days, measure the silver ion stripping quantity through the time change.Mensuration result is as shown in table 6.
On the other hand,, use the solution that soaks antibiotic property pipe A, antibiotic property pipe D, measure according to vibration (shake) method of stipulating in the antibacterial tests technical protocol meeting specification to antibiotic activity value.In addition, soak after 0 day through being determined at respectively in the solution, the antibacterial activity value after 7 days, after 14 days, after 21 days, after 28 days, measure the antibacterial activity value through the time change.Mensuration result is as shown in table 7.
About the mensuration of silver ion stripping quantity, though 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 the antibacterial activity value, the antibacterial activity value of the antibiotic property pipe A of embodiment 1 does not descend, and is keeping higher value.That is, based on more than, the antibiotic property pipe A of embodiment 1 can bring into play antibiotic property for a long time.
On the other hand, the antibiotic property pipe D of comparative example 3 showed the antibacterial activity value equal with embodiment 1 after 14 days, but through after 21 days, after 28 days, the antibacterial activity value reduces.
Therefore, can prove that the antibiotic property pipe A of embodiment 1 compares with the antibiotic property pipe D of comparative example 3, brings into play higher antibacterial activity value for a long time.
Then, reaffirm the state of the antibacterial that the antibiotic property tube-surface is being dissolved.
(embodiment 2, comparative example 4)
To antibiotic property pipe E, the antibiotic property pipe F that makes; (the Ha イ テ of Co., Ltd. Hitachi Network ノ ロ ジ one ズ makes, style: (photography direction: with respect to tube-surface is oblique to surface picture S-3400N) through scanning electron microscope; Multiplying power: 3000 times), cross-section photograph (multiplying power: 3000 times), the state of its antibacterial of being dissolved of surface of Visual Confirmation.Moreover in surface picture (Fig. 8, Figure 10), the cross-section photograph (Fig. 9, Figure 11), antibacterial is taken to granular.
Can confirm antibiotic property pipe E such as Fig. 8, shown in Figure 9 of embodiment 2, a part of antibacterial is dissolving in the surface of antibiotic property pipe E with the state that exposes.Hence one can see that, antibiotic property pipe E in above-mentioned disbonded test, the antibacterial difficult drop-off.
In addition, the antibiotic property pipe F of comparative example 4 such as Figure 10, shown in Figure 11 can confirm that there is antibacterial on the surface of antibiotic property pipe F.Hence one can see that, and antibiotic property pipe F is in above-mentioned disbonded test, and antibacterial comes off easily.
Claims (7)
1. the manufacturing approach of an antibiotic property medical apparatus is characterized in that, comprises
Order contains the antibacterial solvent and is attached to the lip-deep operation of adhering to of inserting the position in the body at least of medical apparatus, this contain the antibacterial solvent be in the mixed solvent that different the 1st solvent of boiling point and the 2nd solvent form, disperse antimicrobial particles to form and
Order is attached to the said drying process that contains the antibacterial solvent seasoning on said medical apparatus surface.
2. the manufacturing approach of antibiotic property medical apparatus as claimed in claim 1 is characterized in that, the boiling point of said the 1st solvent is lower more than 30 ℃ than the boiling point of said the 2nd solvent.
3. the manufacturing approach of antibiotic property medical apparatus as claimed in claim 1 is characterized in that, said the 1st solvent is the solvent that can not dissolve the surface of said medical apparatus, and said the 2nd solvent can dissolve the surface of said medical apparatus.
4. the manufacturing approach of antibiotic property medical apparatus as claimed in claim 1 is characterized in that, said drying process comprises that room temperature evaporates the 1st treatment process of said the 1st solvent and the 2nd treatment process of said the 2nd solvent of heating evaporation.
5. the manufacturing approach of antibiotic property medical apparatus as claimed in claim 1 is characterized in that, said antimicrobial particles contain in silver-colored load silica dioxide granule, zeolite silver granule, the silver-colored granule at least any.
6. the manufacturing approach of antibiotic property medical apparatus as claimed in claim 1 is characterized in that, the said antibacterial solvent that contains is added with dispersant.
7. an antibiotic property medical apparatus is characterized in that, according to the manufacturing approach manufacturing of each described antibiotic property medical apparatus of claim 1 to claim 6.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2010-073742 | 2010-03-26 | ||
| JP2010073742 | 2010-03-26 | ||
| PCT/JP2011/057096 WO2011118680A1 (en) | 2010-03-26 | 2011-03-24 | Process for production of antimicrobial medical instrument, and antimicrobial medical instrument |
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| Publication Number | Publication Date |
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| CN102639162A true CN102639162A (en) | 2012-08-15 |
| CN102639162B CN102639162B (en) | 2015-03-25 |
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| CN201180004706.XA Active CN102639162B (en) | 2010-03-26 | 2011-03-24 | Process for production of antimicrobial medical instrument, and antimicrobial medical instrument |
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| JP (1) | JP5820804B2 (en) |
| CN (1) | CN102639162B (en) |
| WO (1) | WO2011118680A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108463489A (en) * | 2016-02-11 | 2018-08-28 | 阿波罗恩有限公司 | Effective composition of urethral catheterization and preparation method thereof |
| CN108577908A (en) * | 2018-05-15 | 2018-09-28 | 温州医科大学附属第医院 | A kind of anus drag-hook and preparation method thereof |
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| 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 |
| US10376686B2 (en) | 2014-04-23 | 2019-08-13 | 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 |
| US9789279B2 (en) | 2014-04-23 | 2017-10-17 | Becton, Dickinson And Company | Antimicrobial obturator for use with vascular access devices |
| US20160008569A1 (en) * | 2014-07-08 | 2016-01-14 | Becton, Dickinson And Company | Antimicrobial actuator for opening the side port of a ported catheter |
| US10232088B2 (en) | 2014-07-08 | 2019-03-19 | 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 |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN102639162B (en) | 2015-03-25 |
| JPWO2011118680A1 (en) | 2013-07-04 |
| WO2011118680A1 (en) | 2011-09-29 |
| JP5820804B2 (en) | 2015-11-24 |
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