JPS6137247A - Instrument made of plasticizer migration material and its production - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION 1. Background of the Invention Field of the Invention The present invention relates to a medical device having a bonded portion bonded without using a solvent, a method for manufacturing the same, and an adhesive used for bonding the device.

BACKGROUND ART Conventionally, in the manufacturing process of medical devices made of vinyl chloride resin, structural parts have been bonded together using an adhesive containing a volatile solvent such as THF or shifted hexanone as a main component.

However, there is a risk that the residual solvent may contaminate medical fluids or body fluids when the medical device is used.

In addition, during the manufacturing stage, the manufacturing environment was contaminated by solvents, and sufficient measures needed to be taken to prevent this.In addition, adhesive methods that do not use solvents include epoxy resins, UV adhesives, and hot melt adhesives. However, when used for medical devices made of vinyl chloride resin, sufficient adhesive strength could not be obtained, and there were also problems in terms of safety and workability.

II. OBJECTS OF THE INVENTION The object of the present invention is to solve the problems of the prior art described above, and to provide an adhesive for bonding connection parts using an adhesive that does not contain volatile solvents, and an adhesive that uses this adhesive. The present invention provides a method for manufacturing a medical device in which the connection part is bonded using the above-mentioned adhesive, and a medical device having the connection part bonded using the above-mentioned adhesive, which has excellent adhesive strength and good workability. The aim is to eliminate the risk of contamination of chemicals and body fluids, or any negative impact on product performance.

■Specific structure of the invention The above object is achieved by the present invention described below.

That is, according to a first aspect of the invention, there is provided a plasticizer-migrating material device having at least one adhesive portion, wherein the plasticizer concentration in the plasticizer-migrating material device exhibits a gradient, and the concentration of plasticizer in the plasticizer-migrating material device exhibits a gradient. Provided is a plasticizer-migration material tool characterized in that the distance from the adhesive portion is lower, the lower the value is.

According to a second aspect of the present invention, the plasticizer concentration in the plasticizer-migratable material device having at least one connection portion exhibits a gradient, and the concentration is lower as the distance from the adhesive portion increases. When manufacturing a plasticizer migration material tool, an adhesive made by dissolving 0.5 to 10 parts by weight of vinyl chloride resin in 100 parts by weight of a plasticizer is interposed between the parts to be bonded. , there is provided a method for manufacturing a plasticizer-migration material article, which is characterized in that the adhesive is cured and bonded.

The present invention will be explained in more detail below.

The adhesive used in the present invention is a polyvinyl chloride resin dissolved in a plasticizer, and must contain 0.5 to 10 wt% of solid content before dissolution. If the amount of vinyl chloride resin is less than 0.5 wt%, sufficient adhesive strength and adhesion stability cannot be obtained, and if it exceeds 10 wt%, the viscosity becomes high and becomes gel-like even under heating, significantly impairing workability. result.

As a plasticizer, dioctyl phthalate (DOP),
Anything that can be used as a plasticizer for vinyl chloride resin may be used, such as butyl benzyl phthalate (BBP), epoxidized soybean oil, dioctyl sebacate (DOS), dicyclohexyl (DCHP), diheptyl (DHP), etc.

In manufacturing and working with this adhesive, a base resin (a dispersion of vinyl chloride resin in a plasticizer) with a small particle size is used, a dispersion of this paste resin is prepared, and it is heated and dissolved immediately before bonding. It is good to use it. The dispersion is about 13
When heated to 5°C, the vinyl chloride resin particles melt to form a solution. When this adhesive is cooled after being melted, the vinyl chloride resin does not precipitate again, and when it is heated and then cooled, it becomes agar-like and can be stored, and only needs to be reheated before use.

The adhesive obtained in this way may contain a gelation accelerator such as dibenzylidene-D-sorbitol, if necessary. By adding this gelation accelerator, gelation of the adhesive part is promoted, and the temporary curing time of this adhesive (the time required to obtain low adhesive strength before heat treatment) can be shortened.

When using this adhesive, heating the gel-like or high-viscosity adhesive at room temperature increases the fluidity of the adhesive, increases its applicability to the adhesive points, improves adhesive workability and adhesive stability. improve.

The materials to be adhered to which this adhesive can be used are limited to plasticizer migration materials, that is, materials to which the plasticizer in the above-mentioned adhesive can be diffused or dispersed and migrated into the material. Examples of such plasticizer migration materials include polyvinyl chloride, polycarbonate, acrylate, and methacrylate. Therefore, the connecting portion of the medical device of the present invention must be made of such a material. Moreover, the type of material is not limited as long as it is made of such a material.

Next, the connecting portion is bonded using the adhesive of the present invention,
A method for manufacturing medical devices will be explained.

The adhesive used in the present invention can be used effectively regardless of the shape of the bonded part, but it is particularly effective for bonding tubular members together because it is easy to perform J° post-treatment (heat treatment). Therefore, the following description will be made representatively of adhesion between inner tubular members of a medical device.

FIG. 1 shows the process of bonding tubular members together.

At the end of the tube l to be glued, as shown in FIG. 1a,
The adhesive 2 of the present invention described above is heated and made into a liquid state (see Fig. 1b), and before the adhesive gels, it is applied to the other tube to be connected as shown in Fig. 1C. 3
The adhesive 2 is inserted between the connecting portion 4 of the tubes 1 and 3 by pressing the adhesive 2 into the end of the tube (see FIG. 1d).

At this time, the temperature of the adhesive decreases, causing it to rapidly gel, providing a certain degree of adhesive force between the tubes 1 and 3. This phenomenon also prevents the adhesive from transferring to non-adhesive portions of the tube.

In order to provide the required strength to the bonded portion using the adhesive of the present invention, it is necessary to perform a heat treatment as a post-treatment depending on the required strength. This heat treatment allows rapid curing before bonding.

As shown in FIG. 1d, the tubes are inserted and joined together at room temperature of 20°C. Therefore, the heating performed thereafter is at a temperature higher than room temperature and lower than a temperature that does not adversely affect the adhesive member, and at least one heat treatment can be performed depending on the required adhesive strength. As the first heat treatment, heating in an oven (approximately 60° C.) is preferred as the temperature is such that the plastic is less deformed.

In the case of further heat treatment, heat treatment in an autoclave (approximately 120° C.) is preferred.

Although this exemplary temperature is not a critical temperature for the heat treatment in the present invention, the heat treatment process will be described with reference to an example in which the above two-stage heat treatment is typically performed.

For example, if the required strength of the adhesive part is low, leave it at room temperature for a long time (generally about 24 hours is sufficient, although it varies depending on the adhesive part material, shape, and adhesive composition) without heat treatment. This will cause the adhesive to harden. In order to further increase the strength, the heating conditions may be changed depending on the required strength.

As mentioned above, when the adhesive is applied to the adhesive portion and gelled, an adhesive force of 1 to 2 kg can be obtained.

As shown in the later examples, this was subjected to oven treatment (60
℃ for 3 hours), the adhesive strength is approximately 4 kg, and when autoclave treatment (120° C. Cl2O min) is performed, the adhesive strength is stronger than that obtained with a solvent, and reaches approximately 8 kg. This is plastic (adhesive material)
This is because it is not subject to deterioration due to solvents.

The differences between the adhesive used in the present invention and the adhesive generally referred to as plastisol or paste resin are as follows.

The adhesive used in the present invention is a solution in which vinyl chloride resin is dissolved in a plasticizer, at least during bonding.
Plastisol or paste resins are dispersions. For this reason, after the plasticizer is dispersed and absorbed into the adhesive part of the medical device, the adhesive layer in the former becomes a strong one consisting of entangled vinyl chloride resin molecules, while the latter becomes a strong adhesive layer at high temperatures (over 140 degrees Celsius). ) unless it is melted, it will be a lump of particles infiltrated with plasticizer and will have weak cohesive force. In general, parts made of plastic are sensitive to high temperatures, and it is preferable to bond them at as low a temperature as possible, so the adhesive according to the present invention is superior to the above-mentioned paste resin and the like.

The reason why the strength of the bonded portion increases due to heating is thought to be that the plasticizer further migrates into the members to be bonded due to heating, and the gradient of plasticizer in the bonded portion gradually becomes smaller and becomes homogenized.

■Example In the blood bag shown in FIG. The above parts are made of vinyl chloride 10
It has a composition of 0 parts by weight, 70 parts by weight of DOP, and appropriate amounts of stabilizers, lubricants, etc. The structure after bonding is shown in partial cross section in FIG.

Joint dimensions: Blood collection and connection tube (inner diameter x outer diameter)
3, OX4, 4 (mm) Y-shaped tube (inner diameter x outer diameter) 4, IX6, 5 (mm) Cover tube (inner diameter x outer diameter) 4, IX6.5 (mm) Joining length 6 (m+w) (adhesion Preparation and Application of Agent) Place the formulation shown in the formulation example in a mortar and knead thoroughly with a pestle until there are no lumps.

Formulation example Base Torezin 5 (Product name:
Viniki P440, manufactured by Mitsubishi Monsanto) DOP
100 gelling agent
3 (Product name Nigel Master 0P-0'
5, manufactured by Shin Nippon Rika Co., Ltd.) The adhesive can be adjusted as described above.The appropriate application temperature was investigated depending on the plasticizer used, and the result was as shown in FIG. That is, a temperature range of 0-0 is a suitable temperature range, and at lower temperatures, the solubility of the vinyl chloride resin is low, and at higher temperatures, evaporation of the plasticizer increases, which is not preferred. As can be seen from FIG. 4, the adhesive of the embodiment of the present invention may be used at about 120-130°C.

Various adhesives with different types of plasticizers and amounts of vinyl chloride resin were prepared, and the adhesives were applied at about 130'C as explained in Figure 1, as shown in Figure 3. A bonded part was obtained.

In the various adhesives mentioned above, the adhesive strength of the bonded portion immediately after bonding was 1.2 kg on average, and when left for 24 hours, it was 1.9 kg on average. Since the adhesive strength was too low, the following two steps of heat treatment were performed.

1st stage Temporary adhesion at room temperature 20'C 2nd stage Oven 60°C, 3 hours 3rd stage Autoclave 120°C, 20 minutes Regarding the change in adhesive strength of the bonded part after such a heat treatment process, typical examples are as follows: The adhesion of the cover tube is shown in FIGS. 5 and 6, and the adhesion of the Y-tube is shown in FIGS. 7 and 8, respectively. In these drawings, "before sterilization" means after oven treatment;
"After sterilization" means something that has undergone autoclave sterilization.

As can be seen from the graphs showing these test results, it is clear that the adhesive strength of the bonded portion is dramatically increased by heat treatment compared to that of the bonded portion as it is, and the effect of the present invention is remarkable.

(Test of Adhesive Strength) The above adhesive strength was measured as follows.

Place the part slightly away from the joint between the strograph chucks and measure the strength when pulling in the direction of the central axis of the tube (
Pulling speed 200 m+i/m1n).

(2) Effects of the Invention In the present invention, an adhesive whose main component is a volatile solvent such as THF or cyclohexane is not used. Therefore, a portion of this solvent will not penetrate into the constituent materials of the medical device such as vinyl chloride resin and cannot be completely removed, thereby preventing contamination of medical fluids or body fluids with the solvent during use.

Even if you use epoxy resin, UV adhesive, hot melt, etc. as a bonding method that does not use solvents as described in 2.
In particular, soft vinyl chloride resin has weak adhesive strength and has problems in terms of safety and workability. According to the present invention, sufficient adhesive strength can be obtained, and there is no stickiness at the bonded portion after bonding, so there is no problem in terms of safety and workability.

In the present invention, the plasticizer concentration decreases as the distance from the bonded area increases, so the physical properties between the bonded area and other parts change gradually and do not change abruptly. It has the effect that it is dispersed and peeling at the adhesive part is less likely to occur.

The adhesive used in the present invention can be prepared by simply heating and dissolving a small amount (0.5 to 10 parts by weight) of vinyl chloride resin in a nonvolatile plasticizer, and can also be stored by cooling. Conventional base resins have a high content of vinyl chloride resin and are problematic in handling, but the adhesive of the present invention is easy to handle.

In the adhesive used in the present invention, the necessary adhesive strength can be selected by the heat treatment conditions (heating time), and the heat treatment does not cause the bonded portion to change in quality.

In the bonded part obtained by heat treatment using the adhesive of the present invention, the plasticizer in the adhesive diffuses into the material of the member to be bonded, and the bonded part itself is made of the same material as the member to be bonded. remains, and becomes homogeneous with the parts to be bonded, with no boundaries. Therefore, the adhesive strength is also increased, and after autoclave sterilization, the adhesive strength is greater than that of other parts.

In other words, when the adhesive parts are pulled in opposite directions,
The bonded portion does not peel off, and the adhesive strength is strong enough to cause the other portions other than the bonded portion to break.

[Brief explanation of the drawing]

Figure 1 shows the manufacturing process of the medical device of the present invention - Figure 14;
FIG. 2 is a plan view showing an example of the bonded portion of a blood bag manufactured by the method of the present invention, FIG. 3 is a partial sectional view of the bonded portion of FIG. 2, and FIG. 4 is a preferred application of the adhesive of the present invention. Graphs showing the temperature, FIGS. 5 and 6 are graphs showing the adhesion of the cover tube, and FIGS. 7 and 8 are graphs showing the adhesion of the 7-shaped tube. [Explanation of symbols] 1.3...Tube, 2...Adhesive, 4...Connection part. 10...Blood collection tube, 11 Stomach cover tube. 12... Connecting tube, 13... Y-shaped tube FIG, 2 FIG, 3 (a) i. FIG, 4 FIG, 5 FIG, 6 FIG, 7 FIG, 8

Claims (3)

[Claims] (1) A plasticizer-migration material tool having at least one bonded portion, wherein the plasticizer concentration in the plasticizer-migration material tool exhibits a gradient, and the concentration is lower as the distance from the bonded portion increases. A plasticizer migration material tool characterized by: (2) Made of a plasticizer-migrating material having at least one connection part, in which the plasticizer concentration in the plasticizer-migrating material device exhibits a gradient, and the concentration decreases as the distance from the bonding part increases. When manufacturing the tool, add 100% plasticizer between the parts to be bonded.
A plasticizer migration material product characterized by interposing an adhesive formed by dissolving 0.5 to 10 parts by weight of vinyl chloride resin in parts by weight, and curing the adhesive to bond the product. Production method. (3) The method for manufacturing a plasticizer transferable material tool according to claim 2, wherein the adhesive is cured by heat treatment.