JPH0738879B2 - Medical tape and method of manufacturing the same - Google Patents

Description

The present invention relates to a medical tape and a method for manufacturing the same.

<Prior Art> When inserting a medical device such as a gastric fiberscope, a rectal fiberscope, or a cystoscope into a living body, the patient feels pain or damages the mucous membrane due to friction between the surface of the device and the living mucous membrane. .

In order to prevent this, conventionally, a local anesthetic such as xylokajelly has been applied, but the sufficient effect cannot be obtained, and the damage to the mucous membrane is not eliminated.

On the other hand, it is known that a coating of a lubricating resin is formed by covalently bonding a water-soluble polymer such as a maleic anhydride-based polymer substance to the surface of a base material of a medical device to be inserted into the body (Japanese Patent Laid-Open No. 2004-242242). Sho 59-81341, JP-A-1-195863, JP-B-1
-33181).

However, since medical instruments such as fiberscopes are not disposable, they must be sterilized after each use to avoid bacterial contamination, but the above resin coating deteriorates in lubricity after repeated sterilization.

In addition, it is impossible to remove and re-coat the resin coating before each use at the medical site prior to use.

<Problems to be Solved by the Invention> A main object of the present invention is to be able to remove and re-form a lubricous resin coating each time a medical device is used, and to prevent pain of a patient and damage to a mucous membrane when inserted into the body. Another object of the present invention is to provide a medical tape for a medical device capable of preventing bacterial contamination and a method for manufacturing the medical tape.

<Means for Solving the Problems> Such an object is achieved by the present invention of the following (1) to (8).

(1) A resin coating containing a hydrophilic polymer is applied to one surface of a film substrate, and the hydrophilic polymer is bound to the film substrate by a covalent bond, and the hydrophilic polymer is coated on the other side of the film substrate. A medical tape having an adhesive layer on its surface.

(2) The medical tape according to (1) above, wherein the hydrophilic polymer is a maleic anhydride-based polymer.

(3) The medical adhesive according to (1) or (2) above, wherein the pressure-sensitive adhesive layer contains at least one kind of rubber-based, acrylic-based, polyvinyl-based, silicone-based, polyester-based, and polyurethane-based pressure-sensitive adhesives. tape.

(4) The medical tape according to any one of (1) to (3) above, which is sterilized and packaged in a packaging material capable of maintaining a sterile condition.

(5) The medical tape according to any one of (1) to (4), which is attached to the surface of a medical device that is inserted into the body.

(6) In producing the medical tape according to any one of (1) to (4) above, for forming a resin coating in which only one surface of a base material is exposed and the other surface is encapsulated. A base material body is obtained, the resin coating is applied to the one surface of the base material body, then the other surface of the base material body is exposed, and the adhesive layer is formed on the other surface. A method for producing a medical tape, which comprises forming the medical tape.

(7) The base material is a sheet body, and a pair of sheet bodies are sealed as the base body body so that one surface of the sheet body is exposed and the other surface is internally sealed, The method for producing a medical tape according to (6) above, wherein the seal portion of the base body is cut when the pressure-sensitive adhesive layer is formed.

(8) The method for producing a medical tape according to (6), wherein the base material is a tube body of the base material, and the tube body is axially cut when the pressure-sensitive adhesive layer is formed.

<Specific Configuration> The specific configuration of the present invention will be described in detail below.

The medical tape 1 of the present invention, as shown in FIG.
The resin coating 2 is provided on one surface of the film substrate 3, and the adhesive layer 4 is provided on the other surface.

In principle, the hydrophilic polymer constituting the lubricous resin coating 3 of the present invention is a chain-like, non-crosslinked polymeric substance of -OH, -C.
_{ONH 2, -COOH, -NH 2,} -COO -, -SO 3 -, those having a hydrophilic group such as -NR ₃ ^+, natural polymer 1) starch-based carboxymethyl starch, dialdehyde starch 2) cellulosic CMC, MC, HEC, HPC 3) Tannins, nignin tannins, nignin 4) Polysaccharides alginic acid, gum arabic, guar gum, tragacanth, tamarind species 5) Protein gelatin, casein, glue, collagen synthetic polymer 1) PVA polyvinyl Alcohol 2) Polyethylene oxide type polyethylene oxide, polyethylene glycol 3) Acrylic acid type sodium polyacrylate 4) Maleic anhydride type methyl vinyl ether maleic anhydride copolymer 5) Phthalic acid type polyhydroxyethyl phthalate ester 6) Water-soluble polyester Polydimethyl roll propionate Tel 7) ketone aldehyde resins methyl isopropyl ketone formaldehyde resin 8) acrylamide polyacrylamide 9) Polyvinyl pyrrolidone PVP 10) polyamine polyethyleneimine 11) polyelectrolyte polystyrene sulfonate 12), etc. Other water-soluble nylon.

Among these, maleic anhydride-based polymers, cellulose-based polymers, polyethylene oxide-based polymers,
It is preferable that the water-soluble nylon has high lubricity when wet and its durability.

And, such an effect becomes extremely high particularly when a maleic anhydride-based polymer substance is used.

In this case, the maleic anhydride-based polymer substance may be a homopolymer or a copolymer of maleic anhydride.

Of these, a methyl vinyl ether maleic anhydride copolymer or a partial ester thereof is particularly preferable. Such include the approximately 1: 1 copolymer commercially available as GANTREZ AN from GAF Corporation.

Further, the derivative is not limited to water-soluble, and is not particularly limited as long as it has the above-mentioned hydrophilic polymer as a basic constitution, and the insolubilized one has a degree of freedom in the molecular chain as described below and also contains water. If

For example, an esterified product, salt, amidated product, anhydride, halide, etherified product, hydrolyzed product, acetalized product, formalized product, alkyne obtained by condensation, addition, substitution, oxidation, reduction reaction or the like of the above hydrophilic polymer. Roll compound, quaternary compound, diazo compound, hydrazide compound, sulfonate compound, nitrate compound, ion complex; diazonium group, azido group, isocyanate group, acid chloride group, acid anhydride group, iminocarbonic acid ester group, amino group, carboxyl group , Cross-linked products with substances having two or more reactive functional groups such as epoxy groups, hydroxyl groups, aldehyde groups, etc .; copolymers with vinyl compounds, acrylic acid, methacrylic acid, diene compounds, maleic anhydride, etc. is there.

Such a hydrophilic polymer dissolves well in water, and if the solution is allowed to exist between certain objects, the frictional resistance between the two can be significantly reduced and it can be used as a lubricant. Derivatives obtained by condensation or addition reaction or substitution reaction of these water-soluble polymer substances, and those partially crosslinked are also effective as the lubricant.

By covalently bonding these to the reactive functional group existing in or introduced into the base material of the film base material 3 or on the surface of the base material, it becomes possible to obtain a lubricating layer supported on the base material, and the lubricating layer is supported on water. A continuous lubricious surface can be obtained without melting.

The average molecular weight of these hydrophilic polymers is not particularly limited, but those having a molecular weight of about 15 to 5 million have high lubricity, are excessively thick, and can obtain a lubricating layer having a notably large swelling degree when hydrated. Is.

The reactive functional group that is present or introduced in or on the surface of the base material is not particularly limited as long as it reacts with the hydrophilic polymer and bonds or crosslinks and fixes it.
Diazonium groups, azido groups, isocyanate moieties, acid chloride groups, acid anhydride groups, iminocarbonic acid ester groups, amino groups, carboxyl groups, epoxy resins, hydroxyl groups, aldehyde groups, etc. are considered, especially isocyanate groups, amino groups,
Aldehyde groups and epoxy groups are preferred.

Therefore, as the base material 3 containing a reactive functional group, polyurethane, polyamide, etc. are suitable. Also, the base material 3
As those, those not containing these reactive functional groups can also be used. In such a case, it is treated with a substance having a reactive functional group as described above, the reactive functional group is allowed to exist on the substrate, and the hydrophilic polymer is covalently bonded thereto.

Examples of the substance having such a reactive functional group include ethylene diisocyanate, hexamethylene diisocyanate, xylene diisocyanate, toluene diisocyanate, diphenylmethane diisocyanate, naphthalene diisocyanate, diphenylmethane diisocyanate, phenylene diisocyanate, cyclohexylene diisocyanate, triphenylmethane triisocyanate. Polyisocyanates such as isocyanates, tolustoisocyanates, and adducts or prepolymers of these polyisocyanates and polyols. Furthermore, for example, as low molecular weight polyamines ethylenediamine, trimethylenediamine, 1,2-diaminopropane, tetramethylenediamine, 1,3-diaminobutane, 2,3-diaminobutane, pentamethylenediamine, 2,4-diaminopentane, hexa Methylenediamine, octamethylenediamine, nonamethylenediamine, decamethylenediamine, undecamethylenediamine, dodecamethylenediamine, tridecamethylenediamine, octadecamethylenediamine, N, N-dimethylethylenediamine, N, N-diethyltrimethylenediamine, N, N-dimethyltrimethylenediamine, N, N-dibutyltrimethylenediamine, N, N, N'-
Triethylethylenediamine, N-methyltrimethylenediamine, N, N-dimethyl-p-phenylenediamine,
N, N-dimethylhexamethylenediamine, diethylenetriamine, triethylenetetramine, tetraethylenepentamine, heptaethyleneoctamine, nonaethylenedecamine, 1,3-bis (2'-aminoethylamino) propane, bis (3-amino Propal) amine, 1,3-bis (3'-aminopropylamino) propane, 1,2,3, -triaminopropane, tris (2-aminoethyl) amine, tetra (aminomethyl) methane, methyliminobis Propylamine, methyliminobisethylamine, ethyliminobisethylamine, N-aminopropyl-2morpholine, N-aminopripyl-2-pipericone, N-
(2-hydroxyethyl) trimethylenediamine, xylylenediamine, phenylenediamine, piperazine, N
-Methylpiperazine, N- (2-aminoethyl) ethanolamine, N-aminoethylpiperazine, N, N, N ',
N'-tetramethylethylenediamine, N, N, N ', N'-tetramethyltetramethylenediamine and the like are mentioned, and poly (alkylene polyamine) synthesized from [I] amine and alkylene dihalide or epichlorohydrin as a high molecular polyamine. [Encyclopedia of Polymer Science and Technology (En
cyclopedia of Polymer Science and Techn-ology) 10
Vol., P. 616], [II] alkyleneimine polymers obtained by ring-opening polymerization of alkyleneimines such as ethyleneimine and propyleneimine [Ensauclopidia.
Of Polymer Science and Technology,
Volume 1, p. 734], [III] and other polyamines such as polyvinylamine and polylysine.

In addition, glutaraldehyde, terephthalaldehyde,
Isophthalaldehyde, dialdehyde, starch, galloxal, malonaldehyde, succinic acid aldolhydr,
Adipaldehyde, pimelindialdehyde, suberindialdehyde, malealdehyde, 2-pentene-1,5
-Polyaldehydes such as dialdehydes, and polyepoxides such as ethylene glycol diglycidyl ether, polyethylene glycol diglycidyl ether, propylene glycol diglycidyl ether, polypropylene diglycidyl ether, hexanediol diglycidyl ether, and trimethylolpropane triglycidyl ether. .

Among these, 4,4'-diphenylmethane diisocyanate, an adduct (adduct) of tolylene diisocyanate and trimethylolpropane, an adduct of hexamethylene diisocyanate and trimethylolpropane, or its trimer, diethylenetriamine is most preferable.

The base material 3 is made of a substance having such a reactive functional group.
The thickness of the resin coating covalently bonded to is about 1 to 20 μm.

In the present invention, there are very few restrictions on the material of the film substrate 3 used.

Therefore, as the base material 3 used, for example, polyamide,
Polyester, polyvinyl chloride, polystyrene, polyacrylic acid ester, polymethacrylic acid ester, polyacrylonitrile, polyacrylamide, polyacrylic acid, polymethacrylic acid, polyethylene, polypropylene, polyvinyl alcohol, polymaleic anhydride, polyethyleneimine. It may be any of various organic polymer film substrates such as polyurethane, polyvinyl acetate, silicone resin, various latexes, and various copolymers and blends thereof.

And various additives may be contained in these base materials as needed.

The material of the base material 3 is particularly a polyvinyl chloride-based, polyurethane-based, polyamide-based, latex-based, or polyester-based material because of its high lubricity sustaining effect.
Polyvinyl chloride type and polyurethane type have solvent solubility such as tetrahydrofuran (THF), improving the adhesive strength,
Sustainability is improved.

Therefore, the base material 3 is preferably a laminated film formed of these suitable polymer materials or laminated with another material.

In this case, the material to be combined should be determined in consideration of safety, easiness of forming the pressure-sensitive adhesive layer, required mechanical properties such as rigidity or flexibility, moldability, laminating suitability, and sealing property. Good.

For example, various thermoplastic or thermosetting resin films of polyester, polyamide, polyethylene, polypropylene, etc., papers, non-woven fabrics, etc. can be used.

The thickness of the film substrate 3 is about 0.01 to 0.2 mm.

On the surface of the base material 3, various organic polymer resin layers are formed on the surface of the base material to introduce a reactive functional group or to blend a resin and a substance having a reactive functional group. It is also possible to provide an adhesive layer.

The resin coating of the present invention may be formed on such a substrate as follows.

When using an ordinary base material that does not contain a reactive functional group, first, an underlayer is formed.

To form the underlayer, the substrate may be dipped in a solution containing the compound having a reactive functional group and then dried.

In such a case, as the solvent to be used, for example, methyl ethyl ketone, methyl isobutyl ketone, ketone-based such as cyclohexanone, butyl acetate, ethyl acetate, carbitol acetate, ester-based such as butyl carbitol acetate, methyl cellosolve, ethyl cellosolve, tetrahydrofuran Etc. ether type, toluene, xylene etc. aromatic, dichloroethane etc. halogenated alkyl type,
Any alcohol type may be used.

However, it is particularly preferable that the solvent is one that causes the resin-made base material 3 to swell without being dissolved. This is because the coating strength of the coating layer is improved and the sustaining effect is further increased.

Examples of such a solvent include tetrahydrofuran,
Methyl ethyl ketone, cyclofuxanone, xylene, methyl alcohol and the like are preferable.

In addition to dipping treatment, brush painting, spinner coating, etc. are also possible.

The subsequent drying step is to evaporate the solvent, and usually it may be performed at room temperature to about 80 ° C. for about 5 minutes to 48 hours.

Such a substrate is then treated with a solution containing the hydrophilic polymer.

The solvent used in this case is one that does not react with the reactive functional groups present in the base material or the underlayer, that is, one that does not react with the isocyanate group or amino group, and methyl ethyl ketone, THF, acetone, etc. are particularly preferable. Particularly, those having solubility or swelling property with respect to the substrate are suitable.

The concentration is preferably 0.1 to 15%, particularly 0.5 to 10%.

The treatment is usually a dipping treatment as described above, but various coating methods can also be used.

The processing temperature is room temperature to 80 ° C., and the processing time is 1 second to 48 hours.

Then, the subsequent drying process is performed at room temperature to 80 ° C. for 5
It only takes about 48 minutes to 48 hours.

In this way, the hydrophilic polymer of the present invention is covalently bonded to the reactive functional group to form the resin coating 2.

In the present invention, the resin coating thus formed may be further subjected to water treatment as described in JP-B-1-33181.

In such a case, in consideration of mass productivity, it is preferable that the resin coating 2 is formed by dipping treatment.

On the other hand, the resin coating 2 is formed only on one surface of the base material 3,
Only the pressure-sensitive adhesive layer 4 is formed on the other surface. At this time, it is preferable to form the pressure-sensitive adhesive layer after the resin coating 2 is formed, because if the pressure-sensitive adhesive layer is coated first, the subsequent handling becomes difficult.

Therefore, in the present invention, it is preferable to obtain the tape 1 by the following procedure.

First, since the resin coating 2 is formed only on one surface of the base material 3, only one surface of the base material is exposed and the other surface is encapsulated or encapsulated, and the base material is not exposed. Prepare your body.

As such a base body, there is a seal body in which both side ends or 3 to 4 side ends of a pair of sheet bodies are sealed.

Further, it may be a tube body such as an inflation tube or a thin-walled extruded tube.

These base materials are subjected to a batch-type immersion treatment using a dipping tank for forming a base layer or a resin coating, or a long base material is used for dipping in these tanks. You may supply continuously and may perform immersion treatment.

In this way, the resin coating is formed on one surface exposed on the surface of the base body.

Next, the surface of the base material having the resin coating, which is encapsulated or encapsulated, is exposed.

More specifically, in the case of the seal body, the seal portion is cut to obtain two sheet bodies.

Alternatively, the tube body is axially cut into a sheet or film.

In this way, the seal body or the tube body is cut to obtain the base material 3 having the resin coating formed on only one surface.

Then, the pressure-sensitive adhesive layer 4 is formed on the other surface.

The pressure-sensitive adhesive used in the pressure-sensitive adhesive layer of the present invention is not particularly limited, but rubber-based, acrylic-based, silicone-based, polyvinyl-based, polyester-based, polyurethane-based are particularly preferred for safety and elimination of inconvenience during wetting. Is.

The rubber-based pressure-sensitive adhesive is usually composed of raw rubber, tackifying resin, softening agent and the like.

Then, the rubber-based pressure-sensitive adhesive is usually prepared by dissolving the above-mentioned various raw materials in an organic solvent and applying it by a coating method such as gravure coating, reverse loin coating or knife over roll coating, and then scattering the solvent to form a pressure-sensitive adhesive layer. Solvent type to be formed, after blending the raw materials in a solid state, it is used in a usage mode such as a solid paste type which is applied by a calendar coat to form an adhesive layer, a hot melt type which is applied by a hot melt coater, In addition to this, various usage forms are possible.

In this case, as the raw material rubber, any of the raw material rubbers used for the adhesive can act, for example, neoprene rubber, polyisoprene, styrene-butadiene rubber, chloroprene rubber, butadiene-acrylonitrile rubber, natural rubber, etc. You can use it.

The acrylic pressure-sensitive adhesive is usually composed of a base polymer, a comonomer, a functional group-containing monomer, etc., and the silicone-based, polyvinyl-based, polyester-based, polyurethane-based pressure-sensitive adhesive is usually composed of a base polymer, a softening agent, etc. .

These adhesives are water-based or solvent-based solution type or suspension type, hot melt type, solid type paste,
It is used in various usage forms such as a reaction type.

In this case, as the base polymer of the raw material, any of the base polymers used in the adhesive can be used. In the case of the acrylic adhesive, for example, various acrylic esters, methacrylic esters, vinyl acetate, acrylic acid, methacrylic acid can be used. , Itaconic acid, maleic anhydride, acrylamide, etc. In the case of silicone-based adhesives, there are, for example, two types, silicone rubber-based and silicone resin-based.

Further, in the case of a polyvinyl adhesive, for example, a vinyl chloride / vinyl acetate copolymer, a vinyl acetate polymer, a polymer such as polyvinyl butyral to which a plasticizer is added may be used.

The pressure-sensitive adhesive layer 4 thus formed has a thickness of 0.5 to 5
It is about 00 μm.

Thereafter, if necessary, the medical tape of the present invention is produced by cutting with a slitter or cutting into a predetermined shape.

The shape, dimensions, etc. of the medical tape 1 are appropriately determined depending on the application, and may be a long film shape, a sheet shape, or the like.

Then, if necessary, a release paper is attached to the pressure-sensitive adhesive layer 4, and the long film is wound around the core.

Such a medical tape is preferably sterilized because of its use.

The sterilization method may be any of known ethylene oxide method, γ-ray method and the like.

And the sterilized tape keeps aseptic condition,
It is packaged in a packaging material having a known structure.

<Operation> The medical tape 1 of the present invention is useful by being attached to the outer periphery of an endoscope such as a stomach or rectal fiberscope, a cystoscope, or a small intestine fiberscope to be inserted into the body.

FIG. 2 shows an example in which the long film-shaped medical tape 1 is wound around the outer periphery of the fiberscope 5 to reduce the frictional resistance on the surface.

In addition, the frictional resistance can be prevented by sticking tape as much as necessary to various catheters, inspection instruments to be introduced into the body, some surgical instruments and the like.

<Examples> Examples of the present invention will be shown below to describe the present invention in more detail.

Example 1 As a base material, a polyvinyl chloride sheet of 0.2 mn was used, and two sheets of the polyvinyl chloride sheet were stacked and the side surfaces were sealed to obtain an elongated bag-shaped seal body.

After this, add 0.1% NaCl and 0.05% NaHCO ₃ to warm water at about 60 ℃.
Dissolve, dip the catheter tube in it, then
It was washed with warm water of 60 ° C. and dried at room temperature.

In this way, a seal body having a lubricous resin coating formed on one surface was obtained.

Next, immerse this catheter tube in THF for a few seconds,
It was dried at room temperature.

Then, dissolve polyvinyl chloride (hereinafter PVC) in THF and
% PVC / THF solution was prepared.

2 to 6% of 4,4'-diphenylmethane diisocyanate (hereinafter referred to as MDI) was dissolved in this solution, and the seal body was immersed in this solution and dried at room temperature.

Further, the seal body is immersed in a 1% THF solution of a half ethyl ester (product name: GANTREZ AN-169 GAF Co., Ltd.) of methyl vinyl ether maleic anhydride copolymer (product name: GANTREZ AN-169 GAF Co., Ltd.), and then the amount of about 60 is obtained. It was dried at ° C.

Next, the sealing portion of the sealing body was cut to obtain two films each having a resin coating on one surface.

After that, the other surface was coated with a pressure-sensitive adhesive layer by using a knife and an overroll method.

As an adhesive, natural rubber is used as a base polymer, and polyterpene, hydrogenated rosin glycerin ester, SB
R (styrene-butadiene copolymer) was added to obtain an adhesive.

This was taped by a slitter and wound around the outer circumference of the fiberscope.

In this way, the fiberscope wound with tape is
It was inserted into a bent tube made of PVC while being filled with tap water, and the maximum resistance value at that time was measured by a tensile tester.

As a result, the insertion resistance was reduced to less than 1/5 of that when the tape was not wound.

<Effects of the Invention> According to the present invention, the tape is adhered to the necessary parts of the medical device as much as necessary, so that the frictional resistance of the part to be inserted into the body is reduced and the burden on the patient or the like is reduced.

What's more, the tape should be replaced after each use,
It is easy to operate and can prevent bacterial contamination and infection.

[Brief description of drawings]

FIG. 1 is a perspective view showing a medical tape of the present invention. FIG. 2 is a perspective view showing an example of use of the medical tape of the present invention. Explanation of code 1 …… Medical tape 2 …… Resin coating 3 …… Film base material 4 …… Adhesive layer 5 …… Fiberscope

Claims (2)

[Claims] 1. A resin coating containing a hydrophilic polymer is applied to one surface of a film substrate, and the hydrophilic polymer is bound to the film substrate by a covalent bond.
A medical tape comprising an adhesive layer on the other surface of the film substrate. 2. In producing the medical tape according to claim 1, a base material for resin coating formation is obtained in which only one surface of the base material is exposed and the other surface is covered. The resin coating is applied to the one surface of the base material, and then the other surface of the base material is exposed to form the pressure-sensitive adhesive layer on the other surface. Manufacturing method for medical tape.