Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/08—Tubes; Storage means specially adapted therefor
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B1/00—Layered products having a non-planar shape
  • B32B1/08—Tubular products
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B27/00—Layered products comprising a layer of synthetic resin
  • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
  • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B27/00—Layered products comprising a layer of synthetic resin
  • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
  • B32B27/302—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising aromatic vinyl (co)polymers, e.g. styrenic (co)polymers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B27/00—Layered products comprising a layer of synthetic resin
  • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
  • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B2250/00—Layers arrangement
  • B32B2250/02—2 layers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B2274/00—Thermoplastic elastomer material
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B2323/00—Polyalkenes
  • B32B2323/10—Polypropylene
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B32—LAYERED PRODUCTS
  • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
  • B32B2439/00—Containers; Receptacles
  • B32B2439/80—Medical packaging

Definitions

• 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 medical tubes includes safety against chemicals, flexibility, and bondability with members to be joined.
• infusion bags such as peritoneal dialysis bags used by patients at home are individually packaged with a packaging resin film and heated after being heated at a predetermined temperature in order to maintain hygiene.
• the medical tube and the infusion bag and other members to be joined are tightly joined by blocking using a thermal load.
• the conventional technique has the following problems. Although close contact bonding by blocking is suitable at a desired bonding location with a member to be bonded or the like, blocking between the tubes or blocking between the tube and the resin film for packaging also occurs. Therefore, there is a problem that it is difficult for the patient to peel off the packaging resin film, and the handling property of the product is poor.
• the medical tube has a problem that it is difficult to change the material from the viewpoint of required performance, actual use, and ease of manufacture.
• a relatively flexible material is preferably tightly bonded to a member to be joined at a temperature during heat sterilization (but unnecessary blocking occurs), whereas a relatively hard material does not cause unnecessary blocking. (However, the desired member to be joined is not tightly joined in the first place). Therefore, at present, regarding medical tubes that require appropriate flexibility, it is a fact that a flexible material is used even if unnecessary blocking occurs.
• 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. .
• the purpose is to provide an infusion bag product with excellent handling properties.
• 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.
• 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.
• the two-layer structure with a specified thickness ratio increases the number of material options to ensure flexibility, while maintaining tight adhesion by blocking with the member to be joined while providing anti-blocking properties except for the joint.
• a medical extruded double-layer tube can be provided.
• the wall thickness of the outer layer is preferably 3% or more and 4% with respect to the wall thickness of the entire tube from the viewpoint of making the flexibility equivalent to the conventional one. It is as follows.
• the heating temperature is not particularly limited, but can be about 110 ° C. to 130 ° C.
• a material having a melting point of the inner layer material of 120 ° C. or lower and a melting point of the outer layer material exceeding 120 ° C. is selected.
• styrene-based elastomers are soft materials that are also used in conventional medical tubes, and have a melting point of about 120 ° C. or less.
• the styrene elastomer portion softens or melts in an atmosphere at 120 ° C., which is suitable for the inner layer.
• polypropylene has a melting point exceeding 160 ° C. and is inferior in flexibility, but does not melt at 120 ° C. and does not cause blocking, and therefore 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.
• 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, does not block the tubes, and does not cause an increase in waste.
• the present invention it is possible to provide a medical extruded double-layer tube having suitable flexibility, excellent product handling, and maintaining product manufacturing efficiency (Claim 1). Moreover, the infusion bag product excellent in handleability can be provided (Claim 2).
• 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.
• the tube is placed on the polypropylene side (inner packaging material) of a packaging resin film composed of a polyamide-based synthetic fiber and polypropylene, and heated at 120 ° C. for a predetermined time to check for blocking. It was.
• the flexibility of the tube was evaluated.
• the flexibility of the tube is difficult to evaluate with one-sided test values. Therefore, the sensory evaluation compared with the conventional product was made by actually bending variously by hand.
• Table 1 shows the evaluation results.
• the table also shows the flexural modulus of the outer layer material.
• the thickness of the outer layer was approximately 6% or less, and it did not have suitable flexibility unless it was somewhat small.
• the outer layer ratio and the inner layer material were examined. That is, the inner layer uses a composite material containing hydrogenated styrene-butadiene rubber (melting point: about 120 ° C.) as a main component and the addition amount of polypropylene (melting point: about 160 ° C.), and the outer layer uses polypropylene (melting point: about 160 ° C.). ) And the thickness was varied from 8% to 2%.
• Evaluation items include sensory evaluation of the ease of insertion into the member to be joined and operability using a clamp that stops liquid with a tube sandwiched, in addition to the presence and flexibility of blocking similar to the preliminary test. I did it. Table 2 shows the results.
• Test 2 when Test 3, Test 3, and Test 4 are compared, these are all thin outer layers, but when they are extremely thin as in 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.
• the wall thickness of the outer layer had a greater effect on the flexibility, insertability, and blocking resistance of the tube than the material composition 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 in the range of 2% to 5%, considering the inner layer material, its blending ratio, tube thickness, length, application, etc. 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%, it can be said that the tube becomes hard.
• the present invention is not limited to the above embodiment, and the inner layer is made of polyethylene, 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 equal to or lower than the heating temperature for performing close contact bonding by blocking, the outer layer is polypropylene, styrene-based elastomer, olefin-based elastomer, or a mixture thereof or a material mainly composed of these, A material 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 the present invention is suitable for applications in which it is tightly bonded to a member to be bonded by blocking.

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• Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Hematology (AREA)
• Public Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Anesthesiology (AREA)
• Mechanical Engineering (AREA)
• Biomedical Technology (AREA)
• Pharmacology & Pharmacy (AREA)
• Pulmonology (AREA)
• Laminated Bodies (AREA)
• Materials For Medical Uses (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Vascular Medicine (AREA)

Priority Applications (2)

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Citations (5)

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• 2012
  • 2012-11-22 JP JP2012256219A patent/JP5962457B2/ja active Active
• 2013
  • 2013-11-22 KR KR1020157013159A patent/KR101704627B1/ko active IP Right Grant
  • 2013-11-22 WO PCT/JP2013/081520 patent/WO2014081014A1/ja active Application Filing
  • 2013-11-22 CN CN201380060791.0A patent/CN104797413B/zh active Active

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