JP5962457B2 - Medical extruded double-layer tube and infusion bag products - Google Patents

Description

  TECHNICAL FIELD The present invention relates to a medical extruded double-layer tube and an infusion bag product using the same, and in particular, a medical extruded double-layer tube that does not cause blocking between tubes or between the tube and other members during heat sterilization and handleability. It is related with the infusion bag product excellent in.

  The performance required for the medical tube includes safety against chemicals and the like, flexibility, bondability with a member to be joined, and the like.

  For example, an infusion bag such as an abdominal dialysis bag used by a patient at home is individually packaged with an infusion bag product with a resin film for packaging in order to maintain hygiene, and is distributed after being heated to a predetermined degree. At this time, the medical tube and the infusion bag and other members to be joined are tightly joined by blocking using a thermal load.

  As a result, in the manufacture of a product incorporating a tube, it was possible to reduce the number of processes, reduce the use of materials such as adhesives, and suppress excessive packaging. In other words, it was possible to increase product manufacturing efficiency.

However, the conventional technique has the following problems.
Adhesive bonding by blocking is suitable at the desired joint location with the member to be joined, etc., but blocking between tubes and blocking between the tube and the packaging resin film also occur, making it difficult for the patient to peel off the packaging resin film, There was a problem that the handleability of the product was inferior.

  On the other hand, the material of the medical tube has a problem that it is difficult to change the material from the viewpoint of required performance, usage record, and ease of manufacture. In particular, the tube is required to have an appropriate flexibility. Generally, at a temperature at the time of heat sterilization, in the case of a relatively flexible material, it is preferably tightly bonded to the member to be bonded (but also unnecessary blocking occurs). In the case of a relatively hard material, unnecessary blocking does not occur. However, since the material is not tightly bonded to a desired member to be bonded, the current situation is that a flexible material is used.

  Conventionally, as disclosed in Japanese Patent Publication No. 1-331389, a method of reducing the contact area between the tube surface and the member to be joined has been proposed, but the blocking is only alleviated and has not been solved.

  In addition, in order to prevent blocking between the tube and the packaging resin film, etc., a method of inserting other sheets such as non-woven fabrics can be considered, but from the viewpoint of increase in the number of product manufacturing steps, increase in waste, and price Not necessarily preferred.

Japanese Patent Publication No. 1-331389 JP 2012-130439 A

  The present invention has been made in view of the above, and an object of the present invention is to provide a medically extruded double-layer tube having suitable flexibility, excellent product handleability, and capable of maintaining product manufacturing efficiency. .

  Moreover, it aims at providing the infusion bag product excellent in a handleability.

  The medically extruded double-layer tube according to claim 1 is a medically extruded double-layer tube that is inserted from the outside into a resin medical member to be bonded and tightly bonded by blocking by heating. Polyethylene, polypropylene, styrene-based elastomer, olefin-based elastomer, or a mixture thereof, or a material having these as a main component, a material having a melting point equal to or lower than the heating temperature, and for the outer layer, polypropylene, styrene-based elastomer, Olefin-based elastomer, or a mixture thereof, or a material containing these as a main component and having a melting point exceeding the heating temperature, and the thickness of the outer layer is 2% to 5% with respect to the thickness of the entire tube It is characterized by being.

  That is, the invention according to claim 1 can provide a medical extruded double-layer tube having suitable flexibility, excellent product handling, and maintaining product manufacturing efficiency. Specifically, the two-layer structure with a specified thickness ratio increases the number of material options to ensure flexibility, while maintaining close contact bonding by blocking with the connected member and providing anti-blocking properties other than the joint. A medical extruded double-layer tube can be provided.

  Note that the thickness of the outer layer is preferably 3% or more and 4% or less from the viewpoint of making the flexibility equivalent to the conventional one because the melting point tends to be relatively higher than the inner layer. The heating temperature is not particularly limited, but can include about 110 ° C to 130 ° C. For example, when heating at 120 ° C, the inner layer material has a melting point of 120 ° C or less, and the outer layer material has a melting point of more than 120 ° C. To do. In addition, for example, styrene-based elastomer is a soft material that is also used in conventional medical tubes, and has a melting point of about 120 ° C. or less, alone or with other higher melting point materials. Even if it is a mixed material, the styrene-based elastomer portion is softened or melted in an atmosphere of 120 ° C. and is suitable for use as an inner layer material. On the other hand, for example, polypropylene has a melting point of more than 160 ° C. and is inferior in flexibility, but does not melt at 120 ° C. and does not block, so it is suitable for use as an outer layer material.

  The infusion bag product according to claim 2 is heated after the infusion bag incorporating the medical extruded two-layer tube according to claim 1 is contained in a packaging resin film, and the medical extruded two-layer tube is closely attached. It is characterized by being joined.

  That is, the invention according to claim 2 can provide an infusion bag product excellent in handleability. Specifically, it is possible to provide an infusion bag product that is easy to peel off the packaging resin film and does not cause an increase in waste.

  According to the present invention, it is possible to provide a medical extruded double-layer tube having suitable flexibility, excellent product handleability, and capable of maintaining product manufacturing efficiency (claim 1). Moreover, the infusion bag product excellent in handleability can be provided (Claim 2).

Hereinafter, embodiments of the present invention will be described in detail.
The medical extruded two-layer tube of the present invention has a two-layer structure having an inner layer and an outer layer. A flexible material is used for the inner layer, and a material having a high melting point is used for the outer layer.

  First, a preliminary test was performed. For the inner layer, two types of styrene elastomer composite materials having a melting point of 120 ° C. or lower, both of which are used in conventional medical tubes, are prepared, and the outer layer is made of polypropylene from each company, and the thickness is 4 of the total thickness. The tube was extruded as ~ 14%.

  As an evaluation, the presence or absence of blocking with the packaging resin film was examined. Specifically, the tube is placed on the polypropylene side (inner packaging material) of a packaging resin film composed of a polyamide-based synthetic fiber and a polypropylene two-layer sheet, heated at 120 ° C. for a predetermined time, and then checked for blocking. It was.

  The flexibility of the tube was also evaluated. The flexibility of the tube is difficult to evaluate with one-sided test values, and the sensory evaluation was based on the fact that it was actually bent by hand and compared with a conventional product.

Table 1 shows the evaluation results. The table also shows the flexural modulus of the outer layer material.

  From Table 1, it was confirmed that the thickness of the outer layer was approximately 6% or less, and it did not have suitable flexibility unless it was small to some extent.

  Next, based on the results of the preliminary test, the ratio of the outer layer and the mixing ratio of the inner layer materials were examined. The inner layer is composed of a hydrogenated styrene-butadiene rubber (melting point: about 120 ° C.) as a main component and the addition amount of polypropylene (melting point: about 160 ° C.) is changed, and the outer layer is made of polypropylene (melting point: about 160 ° C.). The thickness was 8% to 2%.

  In addition to evaluation of blocking and flexibility as in the preliminary test, the evaluation items were sensory evaluation of ease of insertion into the member to be joined and operability using a clamp that stops liquid with a tube interposed therebetween. . Table 2 shows the evaluation results.

  When test 2 and test 7 are compared, even if the outer layer thickness is the same, if the addition ratio of PP is small, the tube becomes soft as a whole and the insertability is impaired. Moreover, when the test 2 and the test 4 are compared with each other, it can be seen that the tube becomes hard as a whole when the outer layer thickness is increased to 1%.

  On the other hand, when Test 2, Test 3, and Test 4 are compared, these are all thin in outer layer thickness, but when tested as extremely thin as Test 4, the blocking resistance is inferior. Moreover, when the test 1 and the test 5 are compared, the outer layer is considerably thick, but the flexibility is inferior or blocking occurs.

  Therefore, it was confirmed that the wall thickness of the outer layer had a greater influence on the flexibility, insertability, and blocking of the tube than the material configuration of the inner layer. That is, the thickness of the outer layer is preferably 3% or more and 4% or less of the whole, and the range of 2% to 5% when the inner layer material, its blending ratio, tube thickness, length, application, etc. are comprehensively considered It was possible to determine that it can be set within. If it is less than 2%, blocking tends to occur due to unevenness during extrusion molding, and if it exceeds 5%, the tube becomes hard.

  In addition, this invention is not limited to said aspect, It is a raw material which has polyethylene, a polypropylene, a styrene-type elastomer, an olefin-type elastomer, or these mixtures as a main component, or these, and has melting | fusing point below the said heating temperature In the outer layer, polypropylene, styrene elastomer, olefin elastomer, or a mixture thereof, or a material having these as a main component and having a melting point exceeding the heating temperature can be used. A material having properties or physical properties required for a medical tube may be selected as appropriate according to the application.

  The tube of this invention is suitable for the use which adheres and adheres to a to-be-joined member by blocking.

Claims (2)

A medical extruded two-layer tube that is inserted into a resin medical member to be joined from outside and tightly bonded by blocking by heating,
For the inner layer, polyethylene, polypropylene, styrene-based elastomer, olefin-based elastomer, or a mixture thereof or a material having these as a main component and having a melting point equal to or lower than the heating temperature,
For the outer layer, polypropylene, styrene-based elastomer, olefin-based elastomer, or a mixture thereof, or a material mainly composed of these, using a material having a melting point exceeding the heating temperature,
A medical extruded two-layer tube, wherein the outer layer has a thickness of 2% to 5% with respect to the thickness of the entire tube. An infusion bag product, wherein the infusion bag incorporating the medical extruded two-layer tube according to claim 1 is accommodated in a packaging resin film and then heated to closely bond the medical extruded two-layer tube. .