CN102791317B - Medical instrument and process for production thereof - Google Patents

Medical instrument and process for production thereof Download PDF

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Publication number
CN102791317B
CN102791317B CN201180013269.8A CN201180013269A CN102791317B CN 102791317 B CN102791317 B CN 102791317B CN 201180013269 A CN201180013269 A CN 201180013269A CN 102791317 B CN102791317 B CN 102791317B
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China
Prior art keywords
lubrication portion
lubricant
lubricity
base material
moistening
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CN201180013269.8A
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CN102791317A (en
Inventor
尾川智一
日野贤树
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Goodman Co Ltd
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Goodman Co Ltd
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    • 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
    • A61L29/085Macromolecular materials
    • 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/10Materials for lubricating medical devices
    • 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
    • A61L2420/00Materials or methods for coatings medical devices
    • A61L2420/08Coatings comprising two or more layers
    • 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
    • A61M2025/0046Coatings for improving slidability

Abstract

Disclosed is a medical instrument which can have excellent wettability by the effect of a coated part that is formed therein and can be constructed by a simple process. Thus, disclosed is a medical instrument (10), in which a coated part (12) is formed on the surface of a base material (11). The coated part (12) comprises: a first lubricant part that can have higher lubricity compared with the lubricity of the base material (11) when the first lubricant part is wetted; and a second lubricant part that is different from the first lubricant part, is arranged on at least a part of the outer surface of the coated part (12), and can have higher initial lubricity compared with the lubricity of the first lubricant part when the second lubricant part is wetted. The first lubricant part comprises a first lubricant material as a lubricant material having higher lubricity compared with the lubricity of the base material when the first lubricant material is wetted, and the second lubricant part comprises a second lubricant material that is different from the first lubricant material.

Description

Medical device and manufacture method thereof
Technical field
The present invention relates to medical device and manufacture method thereof.
Background technology
In the past, conduit etc. such in the medical device that imports to organism, in order to suppress when importing in organism the damage of organism or make the operability of operator improve, the material that when being coated on moistening to the substrate surface of medical device, lubricity is high.As such coating material, such as, use the low frictional properties resins etc. such as various oils, fluororesin, silicone resin such as silicone oil.
In addition, in recent years, from viewpoints such as practicality, organism adaptabilities, the scheme of the lubricity by the substrate surface when substrate surface coating hydrophilic polymer improves moistening is studied (for example, referring to patent documentation 1).Patent Document 1 discloses following scheme: at the solution containing hydrophilic polymer such as the surface of plastic basic unit coating poly(ethylene oxide) (PEO), polyvinylpyrrolidone (PVP), carry out irradiation with radiation afterwards, make hydrophilic polymer be bonded in the surface of plastic basic unit thus.In addition, this Patent Document 1 discloses and PVP can be used as the scheme of preferred hydrophilic polymer from the viewpoint of the associativity with substrate surface.
Prior art document
Patent documentation
Patent documentation 1: Japanese Unexamined Patent Publication 2002-233568 publication
The problem that invention will solve
But when moistening, the quality of lubricity when it starts moistening at first, can greatly affect the operability such as started when importing in organism, even easily be related to the evaluation of the operability of this utensil etc.Therefore, lubricity when starting moistening is at first the key element of particular importance seeking to improve in the operability etc. of medical device, needs to make its optimization.
So, the present inventor etc. obtain such as following opinion: when utilizing PVP to be coated with at the substrate surface of medical device, good to the cementability of base material, but then, the rising of lubricity when starting moistening at first may not be good, also may not deserve to be called and have excellent lubricity when starting moistening at first.In addition, when wanting to realize the multiple performance as the coating of excellence using a kind of material, considering the technology, process etc. of the establishment equal altitudes needing such as new material, is not be easy to.
Summary of the invention
The present invention makes to solve above-mentioned problem, its main purpose is, provide the medical device and manufacture method thereof by having the coating portion that easy method can be utilized to set up with excellent wettability.
For the means of dealing with problems
The present inventor etc. are conceived to: have in the material of lubricity when hydrophilic polymer etc. is moistening, the lubricity started at first when lubricating is different according to each material, specifically, start moistening after be different to lubricity by the time needed for being given full play to.And, find: by adopting following means based on this opinion, thus above-mentioned problem can be solved.
Namely, the present invention is the medical device that a kind of surface at base material is formed with coating portion, it is characterized in that, above-mentioned coating portion has the first lubrication portion and the second lubrication portion, described first lubrication portion is formed by the material different from above-mentioned base material, and lubricity when it is moistening is higher than this base material, described second lubrication portion is formed by the material different from above-mentioned base material, it is arranged on the part different from above-mentioned first lubrication portion and the going up at least partially of the outer surface in this coating portion, and initial lubricity time moistening is higher than described first lubrication portion.
According to above-mentioned formation, the outside in coating portion is exposed in the second lubrication portion that initial lubricity time moistening is higher.Thus, when making this medical device with such as the water system such as blood, body fluid contacts, excellent lubricity is given in the moistening second lubrication portion that initially can utilize to substrate surface.Therefore, this medical device can embody initial lubricity by the second lubrication portion at outer surface, can give play to excellent lubricant effect when starting moistening at first.Therefore, can successfully insert when importing this utensil in organism.
In addition, the present invention is a kind of manufacture method of medical device, it is characterized in that, possesses: the first operation, uses the first solution containing the material different from base material, the first lubrication portion that the lubricity when the surface of above-mentioned base material is formed moistening is higher than this base material; Second operation, after above-mentioned first operation, use the second solution containing the material different from above-mentioned base material, in the part different from above-mentioned first lubrication portion and the going up at least partially of the outer surface of this medical device, the second lubrication portion that initial lubricity when being formed moistening is higher than above-mentioned first lubrication portion.
According to said method, the medical device of the outside in coating portion is exposed in the second lubrication portion that initial lubricity when can make moistening is higher.Therefore, at the medical device making to be made by method of the present invention with such as the water system such as blood, body fluid contacts, give excellent lubricity in the moistening second lubrication portion that initially can utilize to substrate surface.That is, the medical device made by said method can give play to excellent lubricant effect when starting moistening at first, can successfully insert when importing this utensil in organism.
Accompanying drawing explanation
Fig. 1 is the figure of an example in the coating portion representing this medical device.
Fig. 2 is the figure for illustration of the device used in slickness test.
Fig. 3 is the figure of the result of the slickness test represented 2 layers of coating.
Fig. 4 is the figure of the comparative result representing this coating portion and single coating.
Detailed description of the invention
Below, suitably with reference to accompanying drawing, the present invention is described in detail.
This coating portion is configured in the surface of medical device, there is the first lubrication portion and the second lubrication portion, lubricity during described first lubrication portion moistening is higher than base material, and described second lubrication portion is arranged on the part different from this first lubrication portion and wound at least partially on the outer surface in coating portion.And initial lubricity during this second lubrication portion moistening is higher than the first lubrication portion.
(configuration in the first lubrication portion and the second lubrication portion)
About the first lubrication portion in coating portion and the configuration in the second lubrication portion, first, one, for being formed the form at least partially of the outer surface in coating portion by the first lubrication portion and the second lubrication portion.Now, by arranging the first lubrication portion and the second lubrication portion at substrate surface, thus form the coating portion of the monolayer formed by the first lubrication portion and the second lubrication portion.
Preferred form is that the first lubrication portion is configured in than the position of the second lubrication portion closer to substrate side, preferred form is: coating portion adopts the formation of the outermost layer with the outer surface forming this coating portion and the intermediate layer existed between this outermost layer and surface of base material, outermost layer is formed by the second lubrication portion, and intermediate layer is formed by the first lubrication portion.
Fig. 1 represents an example in the coating portion of this medical device.As illustrated in Figure 1 like that, this medical device 10 has coating portion 12 on the surface of base material 11.Coating portion 12 has the outermost layer 12a forming its outer surface and the intermediate layer 12b existed between outermost layer 12a and the surface of base material 11.And in this utensil 10, this outermost layer 12a is formed as the second lubrication portion at least partially, and intermediate layer 12b is formed as the first lubrication portion.Now, can be the form that the second lubrication portion covers the part in the first lubrication portion, the second lubrication portion as shown in Figure 1 that is preferably covers the form in whole first lubrication portion.Thus, when making this utensil 10 contact with blood, body fluid etc., by the lubricant material contained by the second lubrication portion, excellent initial lubricity can be given to the whole outer surface in coating portion 12.
When intermediate layer 12b is formed by the first lubrication portion and outermost layer 12a is formed by the second lubrication portion, other layers such as containing medicament etc. can be there are between layer 12b and outermost layer 12a, preferred form is: as illustrated in Figure 1, outermost layer 12a is stacked with the state connected with intermediate layer 12b, or outermost layer 12a is layered on the 12b of intermediate layer across the transition zone (diagram slightly) containing the material contained by outermost layer 12a and the material contained by the 12b of intermediate layer.Now, outermost layer 12a is fixed on intermediate layer 12b or transition zone by chemical bonding, and that is, preferably, outermost layer 12a can not be fixed on by chemical bonding on the surface of base material 11.Thus, the process (importing etc. of such as functional group) for making outermost layer 12a be fixed on intermediate layer 12b or transition zone can being omitted, the making in coating portion 12 can be made to simplify.Especially in the formation shown in Fig. 1, the first lubrication portion as intermediate layer 12b is configured in than the second lubrication portion as outermost layer 12a closer to the position of base material 11 side, therefore, when not forming outermost layer 12a by the second lubrication portion, lubricant effect when can maintain moistening by this first lubrication portion.Therefore, guarantee coating portion 12 lubricant effect persistence and can make its make simplification in be useful.
(cementability)
About the first lubrication portion and the second lubrication portion are to the cementability of base material, preferably make the first lubrication portion higher than the second lubrication portion to the cementability of base material.More specifically, when lubricity during lubricity during substrate surface when surface configuration first lubrication portion to base material moistening and substrate surface when surface configuration second lubrication portion to base material moistening is compared, high in the lubricity of moistening initial configuration second lubrication this side of portion, the lubricity configuring first this side of lubrication portion is afterwards high, adopts such formation to be preferably.That is, in this coating portion, initial lubricity when embodying moistening by the second lubrication portion, embodies the persistence (durability) of lubricant effect by the first lubrication portion.Thereby, it is possible to give as the multiple greasy properties required by excellent coating relatively easily, i.e. the persistence of initial lubricity and lubricant effect, and then, by this utensil insertion organism time, can smoothly and be reliably inserted into target site.Especially under outermost layer 12a is as shown in Figure 1 the second lubrication portion and intermediate layer 12b is the formation in the first lubrication portion, high adhesiveness can have been given play to the whole bonding plane of coating portion 12 and base material 11, lubricant effect can be given to the continuous surface of base material 11, therefore preferably.
Intermediate layer 12b as the first lubrication portion can carry out bonding across the layer different from intermediate layer 12b at substrate surface, preferably as shown in Figure 1 as the form that the intermediate layer 12b in the first lubrication portion configures in the mode of the surface contact with base material 11.In this situation, the numerous and diverse process for the formation of other layers can be omitted, the simplification of the making of this utensil 10 can be realized.
Now, about the thickness in the first lubrication portion as intermediate layer 12b and the second lubrication portion as outermost layer 12a, preferably make the thickness in the Thickness Ratio second lubrication portion in the first lubrication portion large.Thus, even if when the second lubrication portion does not form outermost layer 12a, also can by fully continuing the lubricant effect on substrate surface as the first lubrication portion of intermediate layer 12b.
As the form making the moistening initial greasy property in the second lubrication portion higher than the first lubrication portion for: make the lubricant material contained by the first lubrication portion (the first lubricant material) become the material that can carry out being cross-linked, make the second lubrication portion contain this first lubricant material.And, make the crosslinked density that formed by the first lubricant material lower than the first lubrication portion in the second lubrication portion, or in the first lubrication portion, make the first lubricant material be cross-linked structure and in the second lubrication portion, do not make the first lubricant material be cross-linked structure.Specifically, make except the first lubricant material, also to contain cross-linking agent or radical initiator as required in the first lubrication portion.On the other hand, make not containing cross-linking agent in the second lubrication portion, or make the content of the cross-linking agent in the second lubrication portion fewer than the content in the first lubrication portion.
Preferred form is, the first lubricant material is contained in the first lubrication portion, and second lubricant material different from the first lubricant material is contained in the second lubrication portion.And, higher than the first lubricant material by initial lubricity when making the second lubricant material moistening, thus embody the moistening initial greasy property in the second lubrication portion.In this situation, make the first lubricant material to the cementability of base material than better during the second lubricant material height.Thus, given play to the duration performance of the lubricant effect in the first lubrication portion by the first lubricant material, its result is: for the first lubrication portion and the second lubrication portion, can embody good cementability or initial lubricity relatively easily respectively than the opposing party.
Such as, as lubricant material, have the material with following characteristic: high to the cementability of substrate surface, can embody greasy property constantly, on the other hand, initial lubricity time moistening is low.Or, on the contrary, the material that initial lubricity when having moistening is high but low to the cementability of substrate surface.In this, in this formation, mutually supplement greasy property (persistence of initial lubricity, lubricant effect) not enough in 1 lubricant material by multiple lubricant material, thus can form by better simply process the coating portion having the persistence of initial lubricity and lubricant effect concurrently.
In order to improve the first lubrication portion to the cementability of base material, the first lubrication portion is preferably made to contain the first lubricant material as main component, further preferably not containing the second lubricant material or the second lubricant material containing trace.Its reason is, by there is the second lubricant material in the first lubrication portion, thus the first lubrication portion (intermediate layer 12b) may be made to reduce the cementability of base material 11, and the persistence of lubricant effect reduces.
First lubricant material is fixed on substrate surface to embody preferably by chemical bonds such as utilizing covalent bond to the cementability of base material.In this situation, as the first lubricant material, it is preferably that use is at least rich in reactive material than the second lubricant material.
There is no particular limitation for the process for fixation of the first lubricant material now.Such as have functional group's bonding of functional group and the lubricant material making substrate surface method or when lubricant material is macromolecular material, to the method etc. of substrate surface glycerol polymerization monomer whose.Now, to the position (substrate surface) of the first lubricant material, bonding first lubricant material, import novel can with the functional group of other functional group's bondings, these functional group's bondings can be made by various chemical reaction, preferred method is: at the solution of the coatings such as substrate surface containing the first lubricant material, afterwards, by the irradiation etc. of radiation, plasma, ultraviolet etc., the functional group of substrate surface and functional group's bonding of lubricant material is made.According to this process for fixation, the chemical bonding of the first lubricant material and substrate surface can be carried out relatively easily.
On the other hand, the second lubricant material, can be fixed on substrate surface or the first lubricant material, also can not be fixed on substrate surface or the first lubricant material.Its reason is, even if the second lubricant material is not fixed on substrate surface or the first lubricant material, also can be continued the lubricant effect of substrate surface by the first lubricant material.In addition, without the need to using to the high material of the cementability of base material as the second lubricant material, the range of choice of material is wide.
Contain the second lubricant material in the second lubrication portion and play in the formation of initial lubricity by the second lubricant material, the first lubricant material, other lubricant material can be contained in the second lubrication portion.Preferred form is: the second lubrication portion is not containing the lubricant material beyond the second lubricant material, or in the formation containing the first lubricant material, the weight rate of the second lubricant material and the first lubricant material is more than 1.Thereby, it is possible to initial lubricity when maintaining moistening higher.But, in order to suppress the sticky feeling when operator contacts as much as possible, adopting and containing the second lubricant material in the second lubrication portion forming outermost layer 12a and formation containing the first lubricant material is preferably.
In addition, when use can form crosslinked material as the first lubricant material and the second lubricant material, preferably make the crosslinked density ratio second lubrication portion in the first lubrication portion high.More preferably the first lubricant material is crosslinked and the form that the second lubricant material is crosslinked hardly.Thereby, it is possible to the moistening initial hydrophilic in the second lubrication portion of raising.
(the first lubricant material and the second lubricant material)
As the first lubricant material and the second lubricant material, can use different from base material and moistening time the lubricity material higher than base material, wherein, preferably can use hydrophilic polymer.In hydrophilic polymer, to be penetrated etc. by heat or illumination and form intermolecular cross-linking.Hydrophilic polymer after this is crosslinked absorbs water and swelling (moistening) by contacting with the water system such as body fluid, normal saline solution, becomes the hydrogel with lubricity.In such hydrogel, the capture velocity (absorption speed) of water when contacting with water system is different in different materials, and according to the difference of this absorption speed, initial lubricity time moistening can be easy to produce quality.Namely, when contacting with water system, the hydrophilic polymer Fast-swelling that the capture velocity of water is fast, embody lubricity immediately, on the contrary, the hydrophilic polymer that the capture velocity of water is slow reaches swelling for needing to expend the longer time when can embody sufficient lubricity, reaches when embodying good lubricity and needs the longer time.Given this situation is planted, in this coating portion, the capture velocity hydrophilic polymer (the second lubricant material) faster of the outer surface configuration water in coating portion.Thus, when the contact with water system, the outer surface Fast-swelling in coating portion, its result is embody lubricity rapidly at the outer surface of this utensil.
Relevant first lubricant material and the second lubricant material, specifically, first lubricant material is preferably the poly-N-vinyl lactams such as polyvinylpyrrolidone (PVP), ethylene ethyl ether copolymer-maleic anhydride based polymer, with one or more in acrylamide, its derivant polyacrylamide based polymer that is main composition composition etc., is more preferably PVP.PVP has ketopyrrolidine ring, and therefore, when substrate surface exists reactive higher functional group, the activation undertaken by utilizing irradiation ultraviolet radiation etc., can easily carry out the bonding with the functional group of substrate surface.
In addition, as the second lubricant material, be preferably one or more in poly(ethylene oxide) (PEO), hydroxyethyl-cellulose, carboxymethyl cellulose, starch, glucosan, gelatin etc., be more preferably PEO.
Particularly preferably the first lubricant material is PVP and the second lubricant material is the combination of PEO.When lubricity during moistening when substrate surface forms thin film by PVP, PEO respectively being compared, initially moistening, a side of configuration PEO is good in the lubricity of substrate surface, and afterwards, a side of configuration PVP is good in the lubricity of substrate surface.Particularly when the lubricity of slide initial (moistening initial) and later stage (moistening later stage) of sliding being compared with regard to PVP, slip later stage one side has the high such characteristic of lubricity.Therefore, as shown in Figure 1, when being bonded in substrate surface when making PVP and the PEO of initial lubricity excellence is configured in the outer surface in coating portion, apply flexibly the cementability of the excellence that PVP has, and carry out the not enough initial lubricity of supplementary PVP by PEO.
In addition, the persistence of the lubricant effect in PEO is more inferior than PVP, and its reason is thought: compared with PVP, and the reactivity of PEO is low, and its result for not utilize chemical bonding to be fixed between substrate surface and PEO.Consider this point, think that PEO can not be fixed on PVP or namely to allow to fix its crystallized ability also low.On this aspect, in the formation of Fig. 1, maintain the state that PVP is adhered to substrate surface, therefore, As time goes on, even if the persistence of the lubricant effect in the second lubrication portion containing PEO reduces, also lubricant effect can be embodied by PVP constantly at substrate surface.
And then PEO and PVP is general material, easily obtains.In addition, although PEO and PVP is not the material from biology, used as medical application, organism safety, organism adaptability are also excellent.By using the versatile material of multiple such organism safety/organism adaptability excellence, technology without the need to the height like this such as establishment of new material can utilize more easy method to make this coating portion, and excellent lubricating properties time moistening is preferred in this.In addition, compared with PVP, the sticky feeling of PEO when operator contacts is little, and sense of touch is good.Therefore, by the outer surface configuration PEO in coating portion, thus the process of this utensil can be carried out well.
In addition, when using hydrophilic polymer as the first lubricant material, in order to improve the cementability of the first lubricant material and substrate surface, the first lubrication portion is preferably made to contain cross-linking agent.On the other hand, cross-linking agent can be contained in the second lubrication portion, also can not contain cross-linking agent.In addition, as long as the content of the cross-linking agent in the first lubrication portion and the second lubrication portion is suitably determined, when containing excessive cross-linking agent, wettability time moistening reduces, therefore not preferred.
As cross-linking agent, there is no particular limitation, use that such as (1) a part has the monomer of multiple vinyl, (2) have the material, (3) isocyanate compound such as vulcabond, triisocyanate, (4) radical initiator etc. of more than 2 glycidyls at least any one.In addition, as (1), include, for example out neopentylglycol diacrylate (NPGDA), poly alkylene glycol diacrylate (methacrylate) [(gathering) glycol diacrylate (methacrylate), (gathering) propylene glycol diacrylate (methacrylate)], alkanediol diacrylate (methacrylate) etc.As (2), include, for example out poly alkylene glycol diglycidyl ether, neopentyl glycol diglycidyl ether, epoxidised soybean oil etc.As (3), include, for example out the modification body of the vulcabond such as methyl diphenylene diisocyanate, toluene di-isocyanate(TDI), hexamethylene diisocyanate or its adduct, furan first thiophanate (furophanate), biuret, isocyanuric acid ester etc.As (4), azo series initiators, the peroxide series initiators etc. such as azobis isobutyronitrile (AIBN) can be listed, be preferably the initiator producing multiple free radical with a part.Wherein, when using PVP, PEO as lubricant material, the combination of neopentylglycol diacrylate (NPGDA) and radical initiator (such as AIBN) can more preferably be used.
(medical device and base material)
As medical device, as long as the utensil of bio-tissue contact, include, for example out the pipe in the organisms such as blood vessel, digestive tube, urinary catheter, trachea, insert the various conduits, seal wire, support, endoscope, contact lens, artificial blood vessel, artificial joint etc. of body cavity, but not by the restriction of these utensils.
Base material, such as, by polyolefin such as polyether block polyamides copolymer, polyethylene, polypropylene such as Pebax (registered trade mark), the resins such as polyether-ether-ketone, nylon, polyester, polyester elastomer, polyimides, polyurethane, the formations such as metal.Be preferably the resin that polyether block polyamides copolymer, nylon, polyester, polyester elastomer, polyimides, polyurethane, vinyl chloride etc. have polar group.In addition, when carrying out suitable surface treatment in the immobilization in order to carry out the first lubricant material, the polyolefin such as polyethylene, polypropylene, polyether-ether-ketone, metal etc. can be used.
(manufacture method of medical device)
The manufacture method of medical device of the present invention has: the first operation, uses the first solution containing the material different from base material, the first lubrication portion that the lubricity when the surface of above-mentioned base material is formed moistening is higher than this base material; Second operation, after the first operation, use the second solution containing the material different from base material, in the part different from the first lubrication portion and the going up at least partially of the outer surface of this medical device, the second lubrication portion that initial lubricity when being formed moistening is higher than the first lubrication portion.Below, the making step of Fig. 1 to the coating portion 12 shown in Fig. 1 is suitably used to be described.Described coating portion 12, specifically, forms the first lubrication portion as intermediate layer 12b at substrate surface, and the outer surface in coating portion 12 forms the second lubrication portion as outermost layer 12a.
(the first operation)
In the first operation, first, prepare the first solution, described first solution contains the first lubricant material as the material different from base material.As long as the first lubricant material can be dissolved for the preparation of the solvent of the first solution, such as, use alcohol system, distilled water, their mixed solutions etc. such as isopropyl alcohol.Then, the surface contact of the first solution and base material 11 is made.There is no particular limitation for the form of contact, such as, can use the various methods such as coating, dipping, spraying.In addition, before the surface contact of the first solution and base material 11, the surface treatment of the cementability for improving substrate surface and the first lubricant material can be implemented, specifically, the process that such as Corona discharge Treatment, Cement Composite Treated by Plasma, ultraviolet radiation process etc. are this kind of.
Afterwards, under the existence of the first solution, such as, by ultraviolet radiation, the first lubricant material is bonded on the surface of base material 11.Now, when needing cross-linking agent and radical initiator when formation first lubricant material crosslinked, make in the first solution in advance containing cross-linking agent and radical initiator.In addition, such as can form crosslinked lubricant material when there is not cross-linking agent and radical initiator by irradiation ultraviolet radiation etc. for as PVP, also by making in advance containing cross-linking agent and radical initiator in the first solution, thus the cementability of the first lubricant material and substrate surface can be improved.According to upper type, form the first lubrication portion as intermediate layer 12b on the surface of base material 11.
(the second operation)
After first operation terminates, next implement the second operation.In the second operation, first, prepare the second solution, described second solution contains the first lubricant material or the second lubricant material, the second preferably above-mentioned lubricant material as the material different from base material.The solvent of the second solution can be different from the solvent used in the preparation of the first solution, also can be identical solvents.Then, make the outer surface of the second solution and this utensil 10 and the exterior surface of intermediate layer 12b (the first lubrication portion), afterwards, carried out the immobilization of the lubricant material in the second solution by ultraviolet radiation etc.Now, by the irradiation of ultraviolet etc., be cross-linked with making the first lubricant material equal extent in the generation of the lubricant material in the second solution and the first lubrication portion, the state that the first lubricant material in preferably crosslinked density ratio first lubrication portion is low or the state be not crosslinked.In addition, can cross-linking agent and radical initiator be contained in the second solution, also can not contain cross-linking agent and radical initiator.According to upper type, the outer surface in the first lubrication portion forms the second lubrication portion as outermost layer 12a.
As the first lubricant material and the second lubricant material, the combination of preferably polyethylene ketopyrrolidine (PVP) and poly(ethylene oxide) (PEO).In addition, in the second solution containing the second lubricant material, the PEO concentration in the second solution under the combination of the concentration of this second lubricant material, particularly PVP and PEO, preferably more than 0.1 % by weight and less than 1.0 % by weight.By making this concentration be more than 0.1 % by weight, thus the amount of the second lubricant material contained by outermost layer 12a can be made to become be enough in the moistening initial amount playing excellent lubricant effect.In addition, by making this concentration be less than 1.0 % by weight, the amount of the second lubricant material contained by outermost layer 12a can not become too excessive, the second lubricant material when moistening by moderately swelling.Be more preferably more than 0.1 % by weight and less than 0.82 % by weight, more preferably more than 0.2 % by weight and less than 0.55 % by weight.Especially, when this concentration be more than 0.25 % by weight and less than 0.5 % by weight, excellent lubricity can be given to substrate surface.
The thickness in the first lubrication portion and the second lubrication portion can adjust according to the concentration of the lubricant material in the application frequency of the first solution and the second solution, solution.Therefore, in order to make the first lubrication portion thicker than the second lubrication portion, make the concentration of the second lubricant material in concentration ratio second solution of the first lubricant material in the first solution high or mostly the application frequency of the first solution is preferably than the application frequency of the second solution.
Embodiment
Below, the present invention will be described to enumerate concrete example, but the present invention is not defined as following embodiment.
(1) preparation of coating solution
The coating solution be coated with is carried out for the preparation of the substrate surface at medical device.At this, prepare PVP coating solution and PEO coating solution two kinds.PVP coating solution uses mixed solvent isopropyl alcohol and distilled water mixed with 4: 1 (weight ratios), add polyvinylpyrrolidone (PVP wherein, grade K-90, molecular weight is 360,000, medicine manufacture pure with light), neopentylglycol diacrylate (manufacture of NPGDA, ALDRICH company), azobis isobutyronitrile (AIBN, KISHIDA chemistry), stir, prepare this coating solution thus.About the concentration in PVP coating solution, PVP is 0.82 % by weight, NPGDA is 15 % by weight relative to PVP amount.In addition, a small amount of AIBN is added.
PEO coating solution uses the mixed solvent identical with PVP coating solution, adds poly(ethylene oxide) (manufacture of PEO, SIGMA-ALDRICH company) wherein, stirs, prepares this coating solution thus.The concentration of the PEO in PEO coating solution is 0.25 % by weight.
(2) coating of base material
As medical device, use the conduit being formed base material by Pebax (registered trade mark), to the surface of this base material, use above-mentioned 2 kinds of coating solutions (PVP coating solution, PEO coating solution) to be coated with.As application step, first, by carrying out to substrate surface the surface treatment that corona discharge carries out base material.Then, be coated with the PVP coating solution prepared by above-mentioned (1) at substrate surface by dip coating, afterwards, carry out 90 seconds UV and irradiate.At this, this series of process is irradiated in the dip-coating and subsequent UV that utilize PVP coating solution and carries out 2 times.Afterwards, be coated with at the outer surface of conduit the PEO coating solution prepared by above-mentioned (1) further by dip coating, carry out 30 seconds UV and irradiate.Thus, obtain forming PVP layer at substrate surface, forming the conduit of PEO layer (with reference to Fig. 1) in the more lateral of this PVP layer.In addition, during the conduit of the tactile gained that catches surperficial, not sticky feeling, hands sense of touch is good.
(3) evaluation of lubricity time moistening
(3-1) slickness test
As the slickness test of lubricity during for evaluating moistening to the conduit after coating, the device 20 shown in Fig. 2 is used to determine frictional resistance value.As device 20, as shown in Figure 2, the hollow bulb being used in tank 21 is configured with the device of rubber slab 22.In addition, rubber slab 22 can utilize back shaft (diagram slightly) to support with the state being fixed on assigned position.The plate that rubber slab 22 uses natural rubber system, thickness to be 3mm.By making pin vertically puncture (18G) this rubber slab 22, thus arrange thereon and run through the surface of rubber slab 22 and the grooving 23 at the back side.About the mensuration of frictional resistance value, first, insert core (metal) in the inside of a prepared corpse or other object for laboratory examination and chemical testing 24 (conduit), make this corpse or other object for laboratory examination and chemical testing 24 by the grooving 23 of rubber slab 22, and be fixed in and be filled with in the tank 21 of water.Now, by back shaft rubber slab 22 is fixed on the assigned position in tank 21.Afterwards, under the state of the position of fixing rubber slab 22, make a corpse or other object for laboratory examination and chemical testing 24 move back and forth at above-below direction, utilize the frictional resistance of frictional resistance determinator (digital ergometer) 25 to rubber slab 22 now and a corpse or other object for laboratory examination and chemical testing 24 to carry out side.Using this measured value as frictional resistance value [gf].Now, haul distance is set to 10cm, travel speed is set to 13 reciprocating/min, measures thus.
(3-2) preparation of a corpse or other object for laboratory examination and chemical testing
As a corpse or other object for laboratory examination and chemical testing for slickness test, 4 corpse or other object for laboratory examination and chemical testing (PEO concentration: 0.1 % by weight, 0.25 % by weight, 0.5 % by weight, 0.82 % by weight) (corpse or other object for laboratory examination and chemical testing is numbered and is respectively 1 ~ 4) that the PEO concentration prepared in PEO coating solution according to the coating process same from above-mentioned (2) is different.In addition, relative to PEO concentration, preparation contains the PEO coating solution of above-mentioned (1) of the NPGDA of 37.5 % by weight, prepares to use this to prepare liquid and utilizes the method same with above-mentioned (2) to carry out being coated with the corpse or other object for laboratory examination and chemical testing (corpse or other object for laboratory examination and chemical testing numbering 5) processed.In addition, corpse or other object for laboratory examination and chemical testing numbering 1 ~ 5 is form PVP layer at substrate surface and outside it, form 2 layers of coating of PEO layer further.
In addition, as comparative example, prepare to utilize dip coating to be coated with a kind of coating solution at substrate surface, and form a corpse or other object for laboratory examination and chemical testing for single coating by irradiating UV.At this, prepare the corpse or other object for laboratory examination and chemical testing (corpse or other object for laboratory examination and chemical testing numbering 6) using 1.0 % by weight PEO coating solutions, used a corpse or other object for laboratory examination and chemical testing (corpse or other object for laboratory examination and chemical testing numbering 7) for 0.82 % by weight PVP coating solution, used these 3 corpse or other object for laboratory examination and chemical testing of a corpse or other object for laboratory examination and chemical testing (corpse or other object for laboratory examination and chemical testing numbering 8) of the coating solution containing 0.50 % by weight PEO and 0.50 % by weight PVP.In addition, NPGDA is added in the coating fluid used in the making of a corpse or other object for laboratory examination and chemical testing for corpse or other object for laboratory examination and chemical testing numbering 6 ~ 8.Now, in corpse or other object for laboratory examination and chemical testing numbering 6, relative to PEO concentration, NPGDA concentration is made to become 37.5 % by weight, in corpse or other object for laboratory examination and chemical testing numbering 7, relative to PVP concentration, NPGDA concentration is made to become 15 % by weight, in corpse or other object for laboratory examination and chemical testing numbering 8, relative to the total concentration of PEO and PVP, NPGDA concentration is made to become 37.5 % by weight.In addition, a small amount of AIBN is little by little added to each solution.The composition of 8 corpse or other object for laboratory examination and chemical testing etc. is concluded and is shown in following table 1.
[table 1]
(3-3) lubricity evaluation time moistening
Each corpse or other object for laboratory examination and chemical testing is carried out to the slickness test of above-mentioned (3-1).Slickness test is carried out after enforcement eo sterilization (EOG sterilizing).In addition, when slickness is tested, make the haul distance of a corpse or other object for laboratory examination and chemical testing when moving back and forth and travel speed identical between each corpse or other object for laboratory examination and chemical testing.
(3-4) the lubricity evaluation of 2 layers of coating
The result of slickness test is carried out as shown in Figure 3 to the corpse or other object for laboratory examination and chemical testing numbering 1 ~ 4 utilizing PEO and PVP to carry out 2 layers of coating.
As shown in Figure 3, first, as initial lubricity time moistening, with regard to 1 back and forth ~ 5 back and forth after each Resistance Value [gf], being 11 ~ 16 in corpse or other object for laboratory examination and chemical testing numbering 1, is 7.5 ~ 9.5 in corpse or other object for laboratory examination and chemical testing numbering 2, being 9.0 ~ 12 in corpse or other object for laboratory examination and chemical testing numbering 3, is 15 ~ 19 in corpse or other object for laboratory examination and chemical testing numbering 4.In addition, in an arbitrary corpse or other object for laboratory examination and chemical testing, along with the increase of reciprocal time, Resistance Value diminishes to increasing the change of side, 50 back and forth after Resistance Value be 1 back and forth after about 1.3 ~ 2.3 times of Resistance Value.As can be seen here, corpse or other object for laboratory examination and chemical testing numbering 1 ~ 4 can continue initial lubricity when maintaining moistening, and the persistence (durability) of lubricant effect is good.
Especially the PEO concentration in PEO coating solution is in the corpse or other object for laboratory examination and chemical testing numbering 3 of corpse or other object for laboratory examination and chemical testing numbering 2 and 0.5 % by weight of 0.25 % by weight, compared with other a corpse or other object for laboratory examination and chemical testing, visible: whole Resistance Values all diminishes, and along with the increase of reciprocal time, the change of Resistance Value diminishes, and sliding is very good.Wherein, especially in corpse or other object for laboratory examination and chemical testing numbering 2, what move back and forth starts (starting moistening at first) most to terminating, and in 4 corpse or other object for laboratory examination and chemical testing, Resistance Value is minimum, and when repeating to move back and forth, Resistance Value is constant also.By initial lubricity when can say that PEO concentration is the corpse or other object for laboratory examination and chemical testing numbering 2 of 0.25 % by weight moistening above and durability the most excellent.
In addition, to make in PEO coating solution, containing in the corpse or other object for laboratory examination and chemical testing numbering 5 of NPGDA, to demonstrate the passing of the Resistance Value roughly the same with corpse or other object for laboratory examination and chemical testing numbering 2,1 back and forth ~ 50 reciprocal after each Resistance Value constant in the scope of 8 ~ 11.As can be seen here, PEO layer can contain NPGDA, also can not contain NPGDA.
And then, to each corpse or other object for laboratory examination and chemical testing, after EOG sterilizing, and then after implementing the activated deterioration test (60 DEG C, 1 month) utilizing heating to carry out, carry out above-mentioned slickness test.Its result is: in an arbitrary corpse or other object for laboratory examination and chemical testing, 1 back and forth after Resistance Value all roughly the same with before activated deterioration test, in addition, 50 back and forth after Resistance Value be 1 reciprocal after less than 1.5 times of Resistance Value.It can be said that the product life of a corpse or other object for laboratory examination and chemical testing 1 ~ 4 is good.
(3-5) with the comparing of single coating
In the corpse or other object for laboratory examination and chemical testing numbering 1 ~ 4 of 2 layers of coating, the corpse or other object for laboratory examination and chemical testing numbering 2 especially good to surface lubrication time moistening, compares with the corpse or other object for laboratory examination and chemical testing numbering 6 (PEO is independent) of single coating, corpse or other object for laboratory examination and chemical testing numbering 7 (PVP is independent), corpse or other object for laboratory examination and chemical testing numbering 8 (mixed stocker of PEO and PVP).Its result as shown in Figure 4.In addition, in Fig. 4, solid line represents the passing of the Resistance Value of corpse or other object for laboratory examination and chemical testing numbering 2, and dotted line represents the passing of the Resistance Value of corpse or other object for laboratory examination and chemical testing numbering 6, and single dotted broken line represents the passing of the Resistance Value of corpse or other object for laboratory examination and chemical testing numbering 7, and double dot dash line represents the passing of the Resistance Value of corpse or other object for laboratory examination and chemical testing numbering 8.In addition, Fig. 4 is the result of the test after heat sterilization and before the enforcement of activated deterioration test.
As shown in Figure 4, in the corpse or other object for laboratory examination and chemical testing numbering 8 of the independent corpse or other object for laboratory examination and chemical testing numbering 6 of PEO and mixed stocker, with regard to 1 back and forth ~ 3 back and forth after Resistance Value with regard to, so large difference with corpse or other object for laboratory examination and chemical testing numbering 2.But in corpse or other object for laboratory examination and chemical testing numbering 6,8, along with the increase of reciprocal time, Resistance Value becomes large, 50 back and forth after, in corpse or other object for laboratory examination and chemical testing numbering 21 back and forth after about 1.3 times of Resistance Value, on the other hand, in corpse or other object for laboratory examination and chemical testing numbering 6,81 reciprocal after about 4 times of Resistance Value.It can be said that, in the single coating (corpse or other object for laboratory examination and chemical testing numbering 6,8) of PEO or mixed stocker, although initial lubricity can be given to medical device, but and the initial lubricity being not so good as corpse or other object for laboratory examination and chemical testing numbering 2 is good like that, in addition, with regard to durability, also inferior than corpse or other object for laboratory examination and chemical testing numbering 2.
With regard to the single coating (corpse or other object for laboratory examination and chemical testing numbering 7) of PVP, from moistening initial Resistance Value [gf], be 18 after reciprocal at 1, all larger than any one of corpse or other object for laboratory examination and chemical testing numbering 2,6,8.If this value and corpse or other object for laboratory examination and chemical testing numbering 2 are compared, be then more than 2 times of corpse or other object for laboratory examination and chemical testing numbering 2.In addition, in corpse or other object for laboratory examination and chemical testing numbering 7, from 1 back and forth ~ 10 back and forth after each Resistance Value, along with reciprocal time increases, Resistance Value diminishes, and afterwards, roughly becomes constant 12 ~ 13.As can be seen here, moistening initial lubricity time moistening in the single coating of PVP is so not good, needs the longer time to when embodying lubricity.In addition, the initial lubricity of PVP is low, and its reason is presumed to: in PVP, and when contacting with water system, the capture velocity (absorption speed) of water when drawing water between strand is slower than PEO, to abundant swelling time need the longer time.
In addition, with regard to corpse or other object for laboratory examination and chemical testing numbering 7, Resistance Value become constant after, Resistance Value is than corpse or other object for laboratory examination and chemical testing numbering 6,8 little, and larger than corpse or other object for laboratory examination and chemical testing numbering 2.From above situation, corpse or other object for laboratory examination and chemical testing numbering 7 and the outer surface of the single coating of PVP are formed compared with the corpse or other object for laboratory examination and chemical testing numbering 6,8 containing the layer of PEO, and initial lubricity time moistening is inferior, on the contrary, can embody good lubricity afterwards.On the other hand, visible, in corpse or other object for laboratory examination and chemical testing numbering 7 and corpse or other object for laboratory examination and chemical testing numbering 2, both is all good for the initial lubricity of corpse or other object for laboratory examination and chemical testing numbering 2 and the persistence (durability) of lubricant effect.To sum up, compared with at least any one single coating of carrying out utilizing PVP and PEO, the initial lubricity of 2 layers of coating one side of PVP layer and PEO layer and excellent in te pins of durability.In addition, about the hands sense of touch on the surface of the conduit of gained, as compared to the single coating of the single coating of PVP, the mixed stocker of PVP with PEO, sticky feeling is also little, and hands sense of touch is also good.
Symbol description
10... medical device, 11... base material, 12... coating portion, 12a... outermost layer, 12b... intermediate layer, 20... device, 21... tank, 22... rubber slab, 23... grooving, a 24... corpse or other object for laboratory examination and chemical testing, 25... frictional resistance determinator.

Claims (13)

1. a medical device, it is the medical device being formed with coating portion on the surface of base material, it is characterized in that,
Described coating portion has the first lubrication portion and the second lubrication portion,
Described first lubrication portion is formed by the material different from described base material, and lubricity time moistening is higher than this base material,
Described second lubrication portion is formed by the material different from described base material, is arranged on the part different from described first lubrication portion and the going up at least partially of the outer surface in this coating portion, and initial lubricity time moistening is higher than described first lubrication portion.
2. medical device according to claim 1, wherein,
The first lubricant material is contained as the lubricant material higher than described base material of lubricity time moistening in described first lubrication portion,
Second lubricant material different from described first lubricant material is contained in described second lubrication portion.
3. medical device according to claim 2, wherein,
Described first lubricant material and described second lubricant material are hydrophilic polymer.
4. medical device according to claim 3, wherein,
Described first lubricant material is polyvinylpyrrolidone, and described second lubricant material is poly(ethylene oxide).
5. the medical device according to any one of claim 2 ~ 4, wherein,
Described first lubricant material is fixed on the substrate by chemical bonding, and described second lubricant material is not fixed on the substrate by chemical bonding.
6. the medical device according to any one of Claims 1 to 4, wherein,
Described first lubrication portion is higher than described second lubrication portion to the cementability of described base material.
7. the medical device according to any one of Claims 1 to 4, wherein,
When lubricity during moistening described in the surface configuration to described base material when the first lubrication portion is compared with lubricity during moistening described in the surface configuration to described base material when the second lubrication portion, high in the lubricity of described second this side of lubrication portion of moistening initial lower configuration, the lubricity configuring described first this side of lubrication portion is afterwards high.
8. the medical device according to any one of Claims 1 to 4, wherein,
The outermost layer that described coating portion has the outer surface forming this coating portion, the intermediate layer existed between this outermost layer and the surface of described base material,
Described outermost layer is formed by described second lubrication portion, and described intermediate layer is formed by described first lubrication portion.
9. medical device according to claim 8, wherein,
Described outermost layer to be stacked on this intermediate layer with the state layer connected with described intermediate layer or across the material contained by the material comprised contained by described outermost layer and described intermediate layer transition zone and be layered on described intermediate layer.
10. a manufacture method for medical device, is characterized in that, comprising:
First operation, uses the first solution containing the material different from base material, the first lubrication portion that the lubricity when the surface of described base material is formed moistening is higher than this base material;
Second operation, after described first operation, use the second solution containing the material different from described base material, in the part different from described first lubrication portion and the outer surface of this medical device at least partially on initial lubricity when the being formed moistening second lubrication portion higher than described first lubrication portion.
The manufacture method of 11. medical devices according to claim 10, wherein,
In described first solution containing the first lubricant material as the lubricant material higher than described base material of lubricity time moistening,
Containing second lubricant material different from described first lubricant material in described second solution.
The manufacture method of 12. medical devices according to claim 11, wherein,
Described first lubricant material is polyvinylpyrrolidone, and described second lubricant material is poly(ethylene oxide).
The manufacture method of 13. medical devices according to claim 11 or 12, wherein,
The concentration of described second lubricant material in described second solution is more than 0.2 % by weight and less than 0.55 % by weight.
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