CN101536961A - Safe blood or blood component storage container and preparation method thereof - Google Patents
Safe blood or blood component storage container and preparation method thereof Download PDFInfo
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- CN101536961A CN101536961A CN200910066856A CN200910066856A CN101536961A CN 101536961 A CN101536961 A CN 101536961A CN 200910066856 A CN200910066856 A CN 200910066856A CN 200910066856 A CN200910066856 A CN 200910066856A CN 101536961 A CN101536961 A CN 101536961A
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- polyurethane
- polyvinyl chloride
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- 210000004369 blood Anatomy 0.000 title claims abstract description 128
- 239000008280 blood Substances 0.000 title claims abstract description 128
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 238000003860 storage Methods 0.000 title claims abstract description 15
- 239000012503 blood component Substances 0.000 title abstract 2
- 239000004800 polyvinyl chloride Substances 0.000 claims abstract description 84
- 229920000915 polyvinyl chloride Polymers 0.000 claims abstract description 84
- 229920002635 polyurethane Polymers 0.000 claims abstract description 76
- 239000004814 polyurethane Substances 0.000 claims abstract description 76
- 239000002131 composite material Substances 0.000 claims abstract description 38
- 150000001875 compounds Chemical class 0.000 claims description 59
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 52
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 claims description 47
- 239000000470 constituent Substances 0.000 claims description 41
- 238000007664 blowing Methods 0.000 claims description 24
- 230000006835 compression Effects 0.000 claims description 24
- 238000007906 compression Methods 0.000 claims description 24
- 238000000071 blow moulding Methods 0.000 claims description 16
- 229910000831 Steel Inorganic materials 0.000 claims description 12
- 239000010959 steel Substances 0.000 claims description 12
- 238000003466 welding Methods 0.000 claims description 12
- 230000008859 change Effects 0.000 claims description 9
- 210000003743 erythrocyte Anatomy 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 6
- 238000005520 cutting process Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 230000001105 regulatory effect Effects 0.000 claims description 5
- 238000010276 construction Methods 0.000 claims description 2
- 238000000034 method Methods 0.000 claims description 2
- 229920002725 thermoplastic elastomer Polymers 0.000 claims description 2
- -1 2- ethylhexyl Chemical group 0.000 abstract description 5
- 239000004014 plasticizer Substances 0.000 abstract description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 230000008901 benefit Effects 0.000 abstract description 2
- 230000001954 sterilising effect Effects 0.000 abstract description 2
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 2
- 238000001125 extrusion Methods 0.000 abstract 1
- 238000010101 extrusion blow moulding Methods 0.000 abstract 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 abstract 1
- 238000005476 soldering Methods 0.000 abstract 1
- 239000010410 layer Substances 0.000 description 117
- 239000000463 material Substances 0.000 description 52
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 10
- 238000001514 detection method Methods 0.000 description 8
- 238000005303 weighing Methods 0.000 description 8
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 7
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 7
- 239000000203 mixture Substances 0.000 description 7
- 230000001070 adhesive effect Effects 0.000 description 6
- 238000012545 processing Methods 0.000 description 6
- 229920001935 styrene-ethylene-butadiene-styrene Polymers 0.000 description 6
- 239000000853 adhesive Substances 0.000 description 4
- 230000036541 health Effects 0.000 description 4
- 239000003595 mist Substances 0.000 description 4
- 239000002991 molded plastic Substances 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000002834 transmittance Methods 0.000 description 4
- 206010018910 Haemolysis Diseases 0.000 description 3
- 239000005038 ethylene vinyl acetate Substances 0.000 description 3
- 239000012760 heat stabilizer Substances 0.000 description 3
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000004677 Nylon Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 230000001627 detrimental effect Effects 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 239000000806 elastomer Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 229910000041 hydrogen chloride Inorganic materials 0.000 description 2
- IXCSERBJSXMMFS-UHFFFAOYSA-N hydrogen chloride Substances Cl.Cl IXCSERBJSXMMFS-UHFFFAOYSA-N 0.000 description 2
- 230000000968 intestinal effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 239000000178 monomer Substances 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 238000005457 optimization Methods 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- XNGIFLGASWRNHJ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920000098 polyolefin Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 229920001862 ultra low molecular weight polyethylene Polymers 0.000 description 2
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- MTAZNLWOLGHBHU-UHFFFAOYSA-N butadiene-styrene rubber Chemical class C=CC=C.C=CC1=CC=CC=C1 MTAZNLWOLGHBHU-UHFFFAOYSA-N 0.000 description 1
- 230000000711 cancerogenic effect Effects 0.000 description 1
- 231100000357 carcinogen Toxicity 0.000 description 1
- 239000003183 carcinogenic agent Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000011229 interlayer Substances 0.000 description 1
- 229920000092 linear low density polyethylene Polymers 0.000 description 1
- 239000004707 linear low-density polyethylene Substances 0.000 description 1
- WQDGUYZIAJKLAB-UHFFFAOYSA-N octan-2-yl nitrite Chemical compound CCCCCCC(C)ON=O WQDGUYZIAJKLAB-UHFFFAOYSA-N 0.000 description 1
- 230000036961 partial effect Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920003225 polyurethane elastomer Polymers 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 229920003048 styrene butadiene rubber Polymers 0.000 description 1
- 239000002341 toxic gas Substances 0.000 description 1
- DCTZJRUXIXPDJP-UHFFFAOYSA-N trihexyl 2-hydroxy-4-oxoheptane-1,2,3-tricarboxylate Chemical compound CCCCCCOC(=O)CC(O)(C(=O)OCCCCCC)C(C(=O)CCC)C(=O)OCCCCCC DCTZJRUXIXPDJP-UHFFFAOYSA-N 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
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- Materials For Medical Uses (AREA)
- Laminated Bodies (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention provides a safe blood or blood component storage container and a preparation method thereof. The storage container comprises a storage bag and a tube; wherein, the storage bag is made of a polyurethane/ polyvinyl chloride double-layer composite cylinder film; the tube is made of a polyurethane/ polyvinyl chloride double-layer composite tube; the inner layer of the polyurethane/ polyvinyl chloride double-layer composite cylinder film is made of polyurethane, and the corresponding outer layer thereof is polyvinyl chloride; the inner surface of the polyurethane/ polyvinyl chloride double-layer composite tube is a polyurethane layer, and the outer surface thereof is a polyvinyl chloride layer. The polyurethane/ polyvinyl chloride double-layer composite cylinder film is prepared by a co-extrusion blow molding method, and the polyurethane/ polyvinyl chloride double-layer composite tube is prepared by a co-extrusion method. The storage container has excellent blood compatibility, can avoid micromolecules such as phthalate di (2- ethylhexyl), plasticizer and the like to pollute the blood, meets the requirements of humid hot sterilization on heat resistance, has the advantages of high mechanical strength, easy bonding and low manufacturing cost, and is suitable for high frequency soldering.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, be specifically related to a kind of safety blood or blood constituent hold-up vessel and preparation method thereof.
Background technology
The polrvinyl chloride low price, high comprehensive performance generally is used as infusion sets for single use, blood transfusion appliance material.Along with clinical practice extensively and profoundly with the relevant medical science and technology development, it is found that there is potential safety hazard in pvc material itself, processing and serviceability on also have many defectives.Corvic can produce a spot of Vinyl Chloride Monomer in producing or processing, this chemical compound has been proved to be carcinogen.In order to obtain the soft PVC goods, must use plasticizer in the processing, wherein, (DEHP) use of plasticizer is maximum for phthalic acid two (2-Octyl Nitrite), and this class plasticizer can enter medicinal liquid and blood, and enters human body thereupon, is detrimental to health.For preventing that polrvinyl chloride from degrading in the course of processing, the chemical compound that adds elements such as leaded, zinc and barium is usually made heat stabilizer, and in use, the heavy metal in these heat stabilizers may enter human body.The waste treatment difficulty of polrvinyl chloride medical disposable material is buried for a long time and is not degraded, and burns then to produce hydrogen chloride with toxic gas such as bioxin, contaminated environment.Polrvinyl chloride adds can decompose the generation hydrogen chloride gas man-hour, not only corrosion processing equipment, and threat operator ' s health.
When blood was preserved 20 days at DEHP polrvinyl chloride hold-up vessel, the content of DEHP reached 83.2 μ g/mL in the whole blood.To body weight is the patient of 60kg, blood transfusion 500mL then takes in 41.6mg DEHP, promptly taking in DEHP is 693 μ g/kg, be more than 5 times of tolerance intake (non-intestinal tolerance every day intake is 40-140 μ g/kg) of the DEHP of Japanese health ministry regulation, surpass the tolerance intake (non-intestinal tolerance every day intake is 600 μ g/kg) of the DEHP of U.S. food Drug Administration regulation.
In view of the problem that pvc material and blood thereof, blood constituent hold-up vessel exist, the new material that all on the research and development price, can contend with both at home and abroad, performance satisfies instructions for use with polrvinyl chloride.Shen Qing non-PVC blood bag material patent has in recent years: United States Patent (USP) 5,026, and 347 disclose SIS/SEBS/butyryl citric acid tri-n-hexyl ester/polyacrylic blend non-PVC blood bag material; Chinese patent 95191306.9 discloses the blend non-PVC blood bag material of ethylene-vinyl acetate copolymer/SIS/SEBS/ultra-low density polyethylene; United States Patent (USP) 5,952,423 disclose the blend non-PVC blood bag material of polypropylene/SIS/SEBS/nylon/citrate/vitamin e; United States Patent (USP) 5,683,768 disclose the blend non-PVC blood bag material of polypropylene/SIS/SEBS/nylon; United States Patent (USP) 6,579,583 disclose the blend non-PVC blood bag material of ethylene-vinyl acetate copolymer/SIS/SEBS/ultra-low density polyethylene; United States Patent (USP) 4,479,989 disclose the blend non-PVC blood bag material of linear low density polyethylene/SIS/SEBS; United States Patent (USP) 4,561,110 disclose the blend non-PVC blood bag material of polyolefin/ethylene-vinyl acetate copolymer etc.
So far, developed the multiple non-PVC material that is suitable for stored blood, blood constituent,, also had many deficiencies, can reduce though these material partial properties can both satisfy instructions for use:
(1) material thermal resistance is relatively poor, and deformation can appear in the blood of preparation, the sterilization of blood constituent storage bag bag high-temperature steam.
(2) material mechanical performance is relatively poor.Non-PVC blood, the blood constituent storage bag bag intensity of preparation are not high, are prone to phenomenons such as breakage, leakage in the application.
(3) the anti-hemolysis poor-performing of material, for improving the small molecular ester compound that the anti-hemolysis performance is added, as: butyryl citric acid tri-n-hexyl ester, citrate, can infiltrate in blood or the medicinal liquid, human body is caused potential hazard.
(4) material cost causes hold-up vessel cost of manufacture height far above pvc material.
(5) dielectric constant of material is generally less, can not adopt simple to operate, high-frequency welding cheaply, and blood bag manufacturing process difficulty strengthens, and cost improves.Above-mentioned non-PVC material is main base material with polyolefin, and its adhesive property is bad, is unfavorable for the connection between bag and the assembling of accessory.
Adopt non-PVC blood bag material, the preparation single layer plastics films can not satisfy the requirement of blood constituent hold-up vessel.By the composite membrane that certain processing method is bonded together, have different monofilms the advantage of monofilm concurrently, can remedy the deficiency of monofilm.United States Patent (USP) 5,529,821 have introduced a kind of composite membrane that can be used for blood storage, and its structure is a two-layer film configuration.The internal layer that contacts with blood made by microphase-separated section bar material, as polyamide elastomer, polyester elastomer, polyurethane elastomer and methacrylate-styrol copolymer, outerly processed by hydrogenated styrene-butadiene block copolymer etc.
Summary of the invention
Problem at polrvinyl chloride blood or the existence of blood constituent hold-up vessel the invention provides a kind of safety blood or blood constituent hold-up vessel and preparation method thereof.
A kind of safety blood provided by the invention or blood constituent hold-up vessel comprise safety blood or blood constituent storage bag and the pipe that contacts with blood or blood constituent;
Described safety blood or blood constituent storage bag are made by urethane/polyvinyl chloride two-layer compound tube film; The effective urethane/polyvinyl chloride double-layer composite pipe that contacts with blood or blood constituent is made;
Described urethane/polyvinyl chloride two-layer compound tube film is made by polyurethane with the internal layer that blood or blood constituent contact, and corresponding outer layer is a polrvinyl chloride; Layer of polyurethane is 1 with the thickness ratio of polyvinyl chloride layer: 2-5, optimization polyurethane layer thickness are 0.05-0.2mm, and the polrvinyl chloride layer thickness is 0.20-0.40mm;
Described urethane/polyvinyl chloride two-layer compound tube film profile as shown in Figure 1.Among Fig. 1,1. polyurethane internal layer; 2. polrvinyl chloride skin
The inner surface of described urethane/polyvinyl chloride double-layer composite pipe is a layer of polyurethane, outer surface is a polyvinyl chloride layer, layer of polyurethane is 1 with the thickness ratio of polyvinyl chloride layer: 2-8, optimization polyurethane layer thickness are 0.05-0.35mm, and the polrvinyl chloride layer thickness is 0.35-0.80mm;
Described urethane/polyvinyl chloride double-layer composite pipe profile as shown in Figure 2.Among Fig. 2,3. layer of polyurethane; 4. polyvinyl chloride layer
Described polyurethane is: Polyurethane Thermoplastic Elastomer, its melt flow rate (MFR) 1-10 shore hardness≤80, hot strength 〉=13MPa, elongation at break 〉=250%;
Described polrvinyl chloride is: plastifying flexible PVC, its shore hardness≤80, hot strength 〉=13MPa, elongation at break 〉=250%.
Described safety blood or blood constituent hold-up vessel hold-up vessel bag are: single bag in whole blood bag, single bag in erythrocyte bag, single bag of platelet, single bag of plasma bags or connect whole blood bag, erythrocyte bag, platelet, plasma bags or transfering bag in the bag more;
Described safety blood or blood constituent hold-up vessel hold-up vessel pipeline are: blood taking tube, pouring pipe or connect connection tube between bag more.
Below introduce the preparation method of a kind of safety blood provided by the invention or blood constituent hold-up vessel.
Preparation urethane/polyvinyl chloride two-layer compound tube film, adopt the coextrusion blow moulding, step and condition are as follows: adopt double-layer coextrusion blowing unit, this unit is made up of two extruders and a co-extruding blow moulding machine head, and described co-extruding blow moulding machine head is the outer side-fed co-extruding blow moulding machine of internal layer central feeding head, ectonexine all the core rod type co-extruding blow moulding machine head or the outer all central feeding co-extruding blow moulding machine heads of internal layer of charging from the side; The polyurethane extruder temperature is: feed zone 140-160 ℃, and compression section 150-180 ℃, metering section 160-190 ℃; The polyvinyl-chloride use extruder temperature is: feed zone 130-150 ℃, and compression section 150-170 ℃, metering section 160-180 ℃; Co-extruding blow moulding machine head temperature is 160-180 ℃;
To dry back polyurethane and polrvinyl chloride, be 1 by weight: 1-8 adds respectively in the polyurethane extruder hopper and polrvinyl chloride extruder hopper of double-layer coextrusion blowing unit, regulate the die orifice of co-extruding blow moulding machine head and the thickness of air blowing parameter change urethane/polyvinyl chloride two-layer compound tube film, change polyurethane extruder and polrvinyl chloride extruder feed rate layer of polyurethane and polrvinyl chloride layer thickness ratio than the urethane/polyvinyl chloride two-layer compound tube film of regulating, urethane/polyvinyl chloride two-layer compound tube film water cooling with blowing, draw by carry-over pinch rolls, collect with the rustless steel pallet.
Preparation urethane/polyvinyl chloride double-layer composite pipe, employing is by coetrusion, step and condition are as follows: adopt coextrusion bimetallic tube unit, this unit is made up of two extruders and a coextrusion bimetallic tube head, and described coextrusion bimetallic tube head is all outer all central feeding coextrusion bimetallic tube heads of charging core rod type coextrusion bimetallic tube head or internal layer from the side of the outer side-fed coextrusion of internal layer central feeding bimetallic tube head, ectonexine; The polyurethane extruder temperature is: feed zone 140-170 ℃, and compression section 160-190 ℃, metering section 170-200 ℃; The polyvinyl-chloride use extruder temperature is: feed zone 140-160 ℃, and compression section 160-180 ℃, metering section 170-190 ℃; Coextrusion bimetallic tube head temperature is 170-190 ℃;
After polyurethane and polrvinyl chloride oven dry, be 1 by weight: 1-8 adds respectively in the polyurethane extruder hopper and polrvinyl chloride extruder hopper of coextrusion bimetallic tube unit, regulate coextrusion bimetallic tube head die orifice and change urethane/polyvinyl chloride two-layer compound tube thickness, change polyurethane extruder and polrvinyl chloride extruder feed rate than layer of polyurethane and the polrvinyl chloride layer thickness ratio of regulating the urethane/polyvinyl chloride double-layer composite pipe, the urethane/polyvinyl chloride double-layer composite pipe of extruding is cooled off by bosh, draw by carry-over pinch rolls, collect with the rustless steel pallet.
With the urethane/polyvinyl chloride two-layer compound tube film and the cutting of urethane/polyvinyl chloride double-layer composite pipe of preparation, make safety blood or blood constituent hold-up vessel with the method and the relevant unit construction of high-frequency welding.
Beneficial effect: a kind of safety blood provided by the invention or blood constituent hold-up vessel, comprise bag and pipeline, the bag that safety blood or blood constituent hold-up vessel contact with blood or blood constituent and the internal layer of tubing are made by polyurethane; Because polyurethane has good blood compatibility, can reduce whole blood and erythrocyte hemolysis rate, alleviates the absorption and the blood coagulation of plasma protein, improve whole blood and blood constituent and preserve quality, prolong storage life.Urethane/polyvinyl chloride two-layer compound tube film and urethane/polyvinyl chloride double-layer composite pipe can prevent that plasticizer, heat stabilizer and the Vinyl Chloride Monomer in the pvc material from entering blood, is detrimental to health.
By regulating urethane/polyvinyl chloride two-layer compound tube film, the thickness of urethane/polyvinyl chloride double-layer composite pipe or the thickness ratio of layer of polyurethane and polrvinyl chloride interlayer, can change urethane/polyvinyl chloride two-layer compound tube film, urethane/polyvinyl chloride double-layer composite pipe breathability, make it be fit to the hematoblastic preservation that the lower erythrocyte of oxygen permeability requirement and oxygen permeability are had relatively high expectations respectively.Polyurethane and polrvinyl chloride have the compatibility preferably, the adhesive property of urethane/polyvinyl chloride two-layer compound tube film, urethane/polyvinyl chloride double-layer composite pipe better is fit to high-frequency welding, and processing and fabricating is easy, good mechanical performance, cost suits to apply far below non-PVC material.
Description of drawings
Fig. 1 is a urethane/polyvinyl chloride two-layer compound tube film profile.
Fig. 2 is a urethane/polyvinyl chloride double-layer composite pipe profile.
The specific embodiment
The numbering and the physical index of embodiment material therefor see table 1 for details.Urethane/polyvinyl chloride composite bobbin film physical property sees Table 2.
Table 1
| The component code name | Trade name | Model | Manufacturer | Hardness (Shao Shi A) |
| A1 | Polyurethane | S-6558 | Hensel steps (China) company limited | 77 |
| A2 | Polyurethane | E-4675 | Hensel steps (China) company limited | 70 |
| B1 | Polrvinyl chloride | S-1000 | Qilu Petrochemical limited company | 78 |
| B2 | Polrvinyl chloride | DS01 | Big electric plastics (Shanghai) Co., Ltd. | 77 |
Embodiment 1
Take by weighing A1, B1 material, add respectively in the double-layer coextrusion blowing unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is the outer side-fed coextrusion of an internal layer central feeding blow-molded plastic.Set 150-160 ℃ of extruder feed zone temperature of A1 material, compression section temperature 160-170 ℃, 170-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B1 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 170-180 ℃ of double-layer coextrusion blowing head temperature.Be after 1: 4 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of double-layer coextrusion blowing unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 3.5,,, draw by carry-over pinch rolls with the urethane/polyvinyl chloride composite bobbin film water cooling of blowing, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.Film thickness, light transmittance, mist degree and the breathability of two-layer compound tube film, test result sees Table 2.
Take by weighing A2, B1 material, add respectively in the coextrusion bimetallic tube unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is all charging core rod type coextrusion two-layer pipes from the side of ectonexine.Set 150-165 ℃ of extruder feed zone temperature of A2 material, compression section temperature 165-175 ℃, 175-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B1 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 175-185 ℃ of coextrusion bimetallic tube head temperature.Be after 1: 6 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of coextrusion bimetallic tube unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 4.5, the double-layer composite pipe of extruding is cooled off by bosh, draw by carry-over pinch rolls, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.
Two-layer compound tube film, double-layer composite pipe cutting with preparation, with high-frequency welding two-layer compound tube film and two-layer compound pouring pipe, two-layer compound blood taking tube and blood transfusion socket are welded together, high-frequency welding two-layer compound tube film bottom, two-layer compound pouring pipe top, with solvent adhesive blood taking needle is assembled on the two-layer compound blood taking tube, preparation safety blood or blood constituent are stored single bag.
Embodiment 2
Take by weighing A1, B2 material, add respectively in the double-layer coextrusion blowing unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is the outer all central feeding coextrusion blow-molded plastics of internal layer.Set 150-160 ℃ of extruder feed zone temperature of A1 material, compression section temperature 160-170 ℃, 170-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B2 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 170-180 ℃ of double-layer coextrusion blowing head temperature.Be after 1: 7 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of double-layer coextrusion blowing unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 5.5, urethane/polyvinyl chloride composite bobbin film water cooling with blowing, draw by carry-over pinch rolls, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.Film thickness, light transmittance, mist degree and the breathability of two-layer compound tube film, test result sees Table 2.
Take by weighing A2, B1 material, add respectively in the coextrusion bimetallic tube unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is all charging core rod type coextrusion two-layer pipes from the side of ectonexine.Set 150-165 ℃ of extruder feed zone temperature of A2 material, compression section temperature 165-175 ℃, 175-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B1 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 175-185 ℃ of coextrusion bimetallic tube head temperature.Be after 1: 6 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of coextrusion bimetallic tube unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 4.5, the double-layer composite pipe of extruding is cooled off by bosh, draw by carry-over pinch rolls, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.
Two-layer compound tube film, double-layer composite pipe cutting with preparation, with high-frequency welding two-layer compound tube film and two-layer compound pouring pipe, two-layer compound blood taking tube and blood transfusion socket are welded together, high-frequency welding two-layer compound tube film bottom, two-layer compound pouring pipe top, with solvent adhesive blood taking needle is assembled on the two-layer compound blood taking tube, preparation safety blood or blood constituent are stored single bag.
Take by weighing A2, B1 material, add respectively in the double-layer coextrusion blowing unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is the outer side-fed coextrusion of an internal layer central feeding blow-molded plastic.Set 150-160 ℃ of extruder feed zone temperature of A2 material, compression section temperature 160-170 ℃, 170-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B1 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 170-180 ℃ of double-layer coextrusion blowing head temperature.Be after 1: 7 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of double-layer coextrusion blowing unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 5.5, urethane/polyvinyl chloride two-layer compound tube film water cooling with blowing, draw by carry-over pinch rolls, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.。Film thickness, light transmittance, mist degree and the breathability of two-layer compound tube film, test result sees Table 2.
Take by weighing A2, B2 material, add respectively in the coextrusion bimetallic tube unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is all charging core rod type coextrusion two-layer pipes from the side of ectonexine.Set 155-160 ℃ of extruder feed zone temperature of A2 material, compression section temperature 165-175 ℃, 175-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B2 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 175-185 ℃ of coextrusion bimetallic tube head temperature.Be after 1: 4 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of coextrusion bimetallic tube unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 2.5, the double-layer composite pipe of extruding is cooled off by bosh, draw by carry-over pinch rolls, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.
Two-layer compound tube film, double-layer composite pipe cutting with preparation, with high-frequency welding two-layer compound tube film and two-layer compound pouring pipe, two-layer compound blood taking tube and blood transfusion socket are welded together, high-frequency welding two-layer compound tube film bottom, two-layer compound pouring pipe top, with solvent adhesive blood taking needle is assembled on the two-layer compound blood taking tube, preparation safety blood or blood constituent are stored single bag.
Embodiment 4
Take by weighing A2, B2 material, add respectively in the double-layer coextrusion blowing unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is the outer all central feeding coextrusion blow-molded plastics of internal layer.Set 150-160 ℃ of extruder feed zone temperature of A2 material, compression section temperature 160-170 ℃, 170-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B2 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 170-180 ℃ of double-layer coextrusion blowing head temperature.Be after 1: 3 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of double-layer coextrusion blowing unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 2.3,,, draw by carry-over pinch rolls with the urethane/polyvinyl chloride two-layer compound tube film water cooling of blowing, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.Film thickness, light transmittance, mist degree and the breathability of two-layer compound tube film, test result sees Table 2.
Take by weighing A2, B2 material, add respectively in the coextrusion bimetallic tube unit, the screw diameter of extruding unit is 40mm, and draw ratio is 36, and head is all charging core rod type coextrusion two-layer pipes from the side of ectonexine.Set 155-160 ℃ of extruder feed zone temperature of A2 material, compression section temperature 165-175 ℃, 175-185 ℃ of metering section temperature; Set 140-155 ℃ of extruder feed zone temperature of B2 material, compression section temperature 150-165 ℃, 160-175 ℃ of metering section temperature; Set 175-185 ℃ of coextrusion bimetallic tube head temperature.Be after 1: 4 polyurethane, the polrvinyl chloride oven dry with weight ratio, add respectively in the polyurethane extruder hopper, polrvinyl chloride extruder hopper of coextrusion bimetallic tube unit, start, setting polyurethane extruder, vinyl chloride extruder feed rate ratio are 1: 2.8, the double-layer composite pipe of extruding is cooled off by bosh, draw by carry-over pinch rolls, after the detection of size outward appearance is qualified, collect with the rustless steel pallet.
Two-layer compound tube film, double-layer composite pipe cutting with preparation, with high-frequency welding two-layer compound tube film and two-layer compound pouring pipe, two-layer compound blood taking tube and blood transfusion socket are welded together, high-frequency welding two-layer compound tube film bottom, two-layer compound pouring pipe top, with solvent adhesive blood taking needle is assembled on the two-layer compound blood taking tube, preparation safety blood or blood constituent are stored single bag.
Table 2
Annotate 1: contrast sample 1 is the hundred special PVC of company erythrocyte bag bags
Annotate 2: contrast sample 2 is the hundred special PVC of company platelet bag bags
Claims (6)
1. safety blood or blood constituent hold-up vessel is characterized in that, comprise safety blood or blood constituent storage bag and the pipe that contacts with blood or blood constituent;
Described safety blood or blood constituent storage bag are made by urethane/polyvinyl chloride two-layer compound tube film; The effective urethane/polyvinyl chloride double-layer composite pipe that contacts with blood or blood constituent is made;
Described urethane/polyvinyl chloride two-layer compound tube film is made by polyurethane with the internal layer that blood or blood constituent contact, and corresponding outer layer is a polrvinyl chloride; Layer of polyurethane is 1 with the thickness ratio of polyvinyl chloride layer: 2-5;
The inner surface of described urethane/polyvinyl chloride double-layer composite pipe is a layer of polyurethane, and outer surface is a polyvinyl chloride layer, and layer of polyurethane is 1 with the thickness ratio of polyvinyl chloride layer: 2-8;
Described polyurethane is: Polyurethane Thermoplastic Elastomer, its melt flow rate (MFR) 1-10 shore hardness≤80, hot strength 〉=13MPa, elongation at break 〉=250%;
Described polrvinyl chloride is: plastifying flexible PVC, its shore hardness≤80, hot strength 〉=13MPa, elongation at break 〉=250%.
2, a kind of safety blood as claimed in claim 1 or blood constituent hold-up vessel is characterized in that, described urethane/polyvinyl chloride two-layer compound tube film, and layer of polyurethane thickness is 0.05-0.2mm, the polrvinyl chloride layer thickness is 0.20-0.40mm.
3, a kind of safety blood as claimed in claim 1 or blood constituent hold-up vessel is characterized in that, described urethane/polyvinyl chloride double-layer composite pipe, layer of polyurethane thickness are 0.05-0.35mm, and the polrvinyl chloride layer thickness is 0.35-0.80mm.
4, a kind of safety blood as claimed in claim 1 or blood constituent hold-up vessel, it is characterized in that described safety blood or blood constituent storage bag are: single bag in whole blood bag, single bag in erythrocyte bag, single bag of platelet, single bag of plasma bags or connect whole blood bag, erythrocyte bag, platelet, plasma bags or transfering bag in the bag more.
5, a kind of safety blood as claimed in claim 1 or blood constituent hold-up vessel is characterized in that, the described pipe that contacts with blood or blood constituent is: blood taking tube, pouring pipe or connect connection tube between bag more.
6, the preparation method of a kind of safety blood as claimed in claim 1 or blood constituent hold-up vessel, it is characterized in that, described preparation urethane/polyvinyl chloride two-layer compound tube film adopts the coextrusion blow moulding, step and condition are as follows: adopt double-layer coextrusion blowing unit, this unit is made up of two extruders and a co-extruding blow moulding machine head, and described co-extruding blow moulding machine head is the outer side-fed co-extruding blow moulding machine of an internal layer central feeding head, ectonexine is the core rod type co-extruding blow moulding machine head or the outer all central feeding co-extruding blow moulding machine heads of internal layer of charging from the side all; The polyurethane extruder temperature is: feed zone 140-160 ℃, and compression section 150-180 ℃, metering section 160-190 ℃; The polyvinyl-chloride use extruder temperature is: feed zone 130-150 ℃, and compression section 150-170 ℃, metering section 160-180 ℃; Co-extruding blow moulding machine head temperature is 160-180 ℃;
To dry back polyurethane and polrvinyl chloride, be 1 by weight: 1-8 adds respectively in the polyurethane extruder hopper and polrvinyl chloride extruder hopper of double-layer coextrusion blowing unit, regulate the die orifice of co-extruding blow moulding machine head and the thickness of air blowing parameter change urethane/polyvinyl chloride two-layer compound tube film, change polyurethane extruder and polrvinyl chloride extruder feed rate layer of polyurethane and polrvinyl chloride layer thickness ratio than the urethane/polyvinyl chloride two-layer compound tube film of regulating, urethane/polyvinyl chloride two-layer compound tube film water cooling with blowing, draw by carry-over pinch rolls, collect with the rustless steel pallet.
Described preparation urethane/polyvinyl chloride double-layer composite pipe adopts by coetrusion, step and condition are as follows: adopt coextrusion bimetallic tube unit, this unit is made up of two extruders and a coextrusion bimetallic tube head, and described coextrusion bimetallic tube head is all outer all central feeding coextrusion bimetallic tube heads of charging core rod type coextrusion bimetallic tube head or internal layer from the side of the outer side-fed coextrusion of internal layer central feeding bimetallic tube head, ectonexine; The polyurethane extruder temperature is: feed zone 140-170 ℃, and compression section 160-190 ℃, metering section 170-200 ℃; The polyvinyl-chloride use extruder temperature is: feed zone 140-160 ℃, and compression section 160-180 ℃, metering section 170-190 ℃; Coextrusion bimetallic tube head temperature is 170-190 ℃;
After polyurethane and polrvinyl chloride oven dry, be 1 by weight: 1-8 adds respectively in the polyurethane extruder hopper and polrvinyl chloride extruder hopper of coextrusion bimetallic tube unit, regulate coextrusion bimetallic tube head die orifice and change urethane/polyvinyl chloride two-layer compound tube thickness, change polyurethane extruder and polrvinyl chloride extruder feed rate than layer of polyurethane and the polrvinyl chloride layer thickness ratio of regulating the urethane/polyvinyl chloride double-layer composite pipe, the urethane/polyvinyl chloride double-layer composite pipe of extruding is cooled off by bosh, draw by carry-over pinch rolls, collect with the rustless steel pallet.
With the urethane/polyvinyl chloride two-layer compound tube film and the cutting of urethane/polyvinyl chloride double-layer composite pipe of preparation, make safety blood or blood constituent hold-up vessel with the method and the relevant unit construction of high-frequency welding.
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| CN102423508A (en) * | 2011-10-19 | 2012-04-25 | 山东威高集团医用高分子制品股份有限公司 | Transfusion conduit of blood transfusion apparatus and preparation method thereof |
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| CA2299691C (en) * | 1999-03-01 | 2011-07-12 | Johnson & Johnson Vision Care, Inc. | Package for medical device |
| JP2001269403A (en) * | 2000-03-27 | 2001-10-02 | Kawasumi Lab Inc | Medical tube |
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