CN110743061A - Infusion bag and portable infusion bag - Google Patents
Infusion bag and portable infusion bag Download PDFInfo
- Publication number
- CN110743061A CN110743061A CN201910957326.6A CN201910957326A CN110743061A CN 110743061 A CN110743061 A CN 110743061A CN 201910957326 A CN201910957326 A CN 201910957326A CN 110743061 A CN110743061 A CN 110743061A
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- Prior art keywords
- layer
- infusion bag
- infusion
- bag
- oxygen
- Prior art date
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- -1 polypropylene Polymers 0.000 claims description 35
- 239000000806 elastomer Substances 0.000 claims description 31
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- QYMGIIIPAFAFRX-UHFFFAOYSA-N butyl prop-2-enoate;ethene Chemical compound C=C.CCCCOC(=O)C=C QYMGIIIPAFAFRX-UHFFFAOYSA-N 0.000 claims description 2
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- SXOCZLWARDHWFQ-UHFFFAOYSA-N dioxathiirane 3,3-dioxide Chemical compound O=S1(=O)OO1 SXOCZLWARDHWFQ-UHFFFAOYSA-N 0.000 claims description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 2
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Images
Classifications
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
-
- 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
- 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
- A61J1/14—Details; Accessories therefor
- A61J1/1468—Containers characterised by specific material properties
-
- 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
- B32B27/18—Layered products comprising a layer of synthetic resin characterised by the use of special additives
-
- 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
-
- 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
- B32B2250/24—All layers being polymeric
- B32B2250/242—All polymers belonging to those covered by group B32B27/32
-
- 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
- B32B2307/00—Properties of the layers or laminate
- B32B2307/20—Properties of the layers or laminate having particular electrical or magnetic properties, e.g. piezoelectric
- B32B2307/212—Electromagnetic interference shielding
-
- 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
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/724—Permeability to gases, adsorption
- B32B2307/7242—Non-permeable
- B32B2307/7244—Oxygen barrier
-
- 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
- B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention discloses an infusion bag and a portable infusion bag. The primary package or the secondary package of the infusion bag is made of a co-extruded shrinkable film; the coextruded shrinkable film includes four film layers from the inside out. The infusion bag can be spontaneously contracted in the air, the extruded medicine is infused at a constant speed, an external power source is not needed, and the infusion bag integrates the advantages of environmental protection, energy conservation and convenience. The portable infusion bag matched with the infusion bag is simple in structure and convenient to use, meets the requirements of patients on activities, toileting and the like in infusion, and ensures that the patients or nurses can observe the infusion process at any time; and the portable infusion bag can be reused without generating any additional medical waste.
Description
Technical Field
The invention relates to the field of medical infusion, in particular to an infusion bag and a portable infusion bag.
Background
The traditional infusion mainly adopts a 'gravity infusion' mode, and infusion is carried out by a fixed or movable infusion support. When a patient needs to move, an attendant needs to lift the infusion bottle or push the movable support, the height of the infusion bottle is continuously maintained, labor intensity is increased for the attendant, and blood backflow easily occurs slightly carelessly. For children with poor compliance, the traditional infusion needs the children to fix the posture and cannot walk freely, so that the probability of crying, struggling and uncombination of the children is increased, and the incidence rate of adverse events such as catheter slippage, accidental needle withdrawal and the like is increased.
In recent years, portable transfusion tools or equipment using a manual air bag, a manual pressurized transfusion bag, an elastic deformation mechanism, a power pump and the like as a power source appear, and the positive pressure difference required by transfusion is not obtained by means of the height difference of the tools or equipment any more in a transfusion mode, and the tools and the equipment are small in size, light in weight and convenient to carry, so that the labor intensity of nursing personnel is reduced, a patient can freely move in the transfusion process, and the trouble of going to the toilet and the like of the patient in the transfusion process is solved.
For example, CN106823043A discloses a portable transfusion waistcoat, which comprises a waistcoat body and a telescopic transfusion rod, wherein the waistcoat body is provided with a transfusion bag, and a rear part of the waistcoat is provided with a fixing belt for installing the transfusion rod. CN109663167A discloses a portable infusion knapsack, contains bag bottle portion, infusion branch pipe, infusion switch etc. and this structure not only is convenient for nurse's nursing, changes dressings, can also satisfy multiple medicament and carry simultaneously.
The portable infusion device has remarkable progress compared with the traditional gravity infusion mode, but has the following defects: manual air bag or manual pressurization requires the other hand of the patient or an attendant to perform cooperative infusion, but increases the nursing difficulty; the power pump or the elastic deformation portable transfusion equipment has a complex structure and cannot really achieve convenience due to the fact that the equipment comprises a power supply, a circuit board, a driving motor and the like, is not suitable for transfusion treatment in hospitals or families, and is more suitable for transfusion treatment in war or disaster environments.
Disclosure of Invention
In order to solve at least one technical problem, the invention provides an infusion bag and a portable infusion bag. The infusion bag adopts a co-extruded shrinkable film as a primary package or a secondary package for infusing the liquid medicine, wherein the primary package is directly contacted with the liquid medicine, and the secondary package is not directly contacted with the liquid medicine and can be used as an outer package. The infusion bag can be spontaneously contracted in the air, the extruded medicine is infused at a constant speed, an external power source is not needed, and the infusion bag integrates the functions of environmental protection, energy conservation and convenience. The invention further designs a portable infusion bag in cooperation with the infusion bag, and on the basis of the existing infusion device, no additional structure is added, and normal infusion can be realized only by hanging the infusion bag in a transparent bag; the infusion support is simple in structure and convenient to use, meets the requirements of patients on movement, toileting and the like during infusion, and ensures that the patients or nurses can observe the infusion process at any time; and the portable infusion bag can be reused without generating any additional medical waste.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the invention provides an infusion bag, the primary or secondary packaging of which is made of a co-extruded shrinkable film;
the coextruded shrinkable film comprises, from inside to outside, four film layers:
the first layer comprises 50 wt.% to 95 wt.% of a co-polypropylene and 5 wt.% to 50 wt.% of a SEBS elastomer;
the second layer comprises 30 wt.% to 65 wt.% of a co-polypropylene, 15 wt.% to 50 wt.% of a polypropylene elastomer, and 10 wt.% to 40 wt.% of SEBS;
the third layer comprises 40 wt.% to 70 wt.% of homopolypropylene, 10 wt.% to 30 wt.% of branched polyethylene, 20 wt.% to 50 wt.% of an oxygen crosslinkable unsaturated elastomer, and 0.5 wt.% to 2 wt.% of an organic peroxide;
the fourth layer comprises 20 wt.% to 60 wt.% of maleic anhydride grafted homopolypolypropylene and 40 wt.% to 80 wt.% of an oxygen barrier or oxygen absorbing component; the oxygen-blocking or oxygen-absorbing component is a polymer with oxygen-blocking property or a blend of the polymer with oxygen-absorbing property and an additive.
Specifically, the raw materials of the four film layers of the co-extruded shrinkable film are respectively melted by an extruder and then are co-extruded to prepare a film; wherein the fourth, outermost layer is peelable from the third layer.
Preferably, the peel strength is not more than 10N/15 mm; the shrinkage rate of the peeled main body film is more than 70 percent.
Preferably, the copolymerized polypropylene in the first layer and the second layer and the homopolymerized polypropylene in the third layer are both medical grade, have radiation resistance, and do not change color under the irradiation condition of 15-25 KGy dose, namely, the change of the yellowness index before and after irradiation is less than or equal to 1.
The first, inner layer is in direct contact with the package contents; the content of the copolymerized polypropylene in the first layer is 50 wt.% to 95 wt.%, and the content of the SEBS elastomer is 5 wt.% to 50 wt.%.
For example, the medical grade, radiation resistant co-polypropylene is present in the first layer in an amount of 75 wt.%, and the SEBS elastomer in an amount of 25 wt.%; or the content of the copolymerized polypropylene is 55 wt.%, and the content of the SEBS elastomer is 45 wt.%.
Preferably, the melting point of the co-polypropylene in the first layer is from 120 ℃ to 135 ℃.
Preferably, the thickness of the first layer is 10 microns to 40 microns; such as 30 microns or 10 microns.
The second layer is an elastic support layer, the content of the copolymerized polypropylene in the second layer is 30-65 wt.%, the content of the polypropylene elastomer is 15-50 wt.%, and the content of the SEBS elastomer is 10-40 wt.%.
For example, the medical grade, radiation resistant co-polypropylene is present in the second layer in an amount of 45 wt.%, the polypropylene elastomer in an amount of 20 wt.%, and the SEBS elastomer in an amount of 5 wt.%; or the content of the copolymerized polypropylene is 65 wt.%, the content of the polypropylene elastomer is 15 wt.%, and the content of the SEBS elastomer is 20 wt.%.
Preferably, the thickness of the second layer is 100-200 microns; such as 130 microns or 140 microns.
The third layer is a shrink body layer, preferably the third layer has a homopolypropylene content of 40 wt.% to 70 wt.%, a branched polyethylene content of 10 wt.% to 30 wt.%, an oxygen crosslinkable unsaturated elastomer content of 20 wt.% to 50 wt.%, and an organic peroxide content of 0.5 wt.% to 2 wt.%.
For example, the third layer has 60 wt.% of medical grade, radiation resistant homopolypropylene, 15 wt.% of branched polyethylene, 24 wt.% of oxygen crosslinkable unsaturated elastomer, and 1 wt.% of organic peroxide; or the third layer comprises the following formula: the medical grade, radiation resistant homopolypropylene is present in an amount of 45 wt.%, the branched polyethylene is present in an amount of 30 wt.%, the oxygen crosslinkable unsaturated elastomer is present in an amount of 23 wt.%, and the organic peroxide is present in an amount of 2 wt.%.
Preferably, the thickness of the third layer is 15 microns to 70 microns; such as 40 microns or 50 microns.
Preferably, the branched polyethylene is one or a combination of two of ethylene-vinyl acetate copolymer (EVA), ethylene-methyl methacrylate copolymer (EMMA), ethylene-ethyl acrylate copolymer (EEA) and ethylene-butyl acrylate copolymer (EBA).
Preferably, the oxygen cross-linkable unsaturated elastomer is one or a combination of two of nitrite rubber, acrylonitrile-butadiene-styrene copolymer (ABS), Styrene Butadiene Rubber (SBR), styrene-butadiene-styrene block copolymer (SBS), polybutadiene rubber (BR), styrene-isoprene-styrene block copolymer (SIS), halogenated acrylonitrile butadiene, Natural Rubber (NR), synthetic polyisoprene rubber (IR), neoprene rubber (CR), polychloroprene, bromobutyl rubber and chlorobutyl rubber.
Preferably, the organic peroxide is a dialkyl peroxide, a diperoxyketal, a monoperoxycarbonate, a cyclic ketone peroxide, a diacyl peroxide, an organic sulfonyl peroxide, a peroxyester, or a peroxydicarbonate. Specific peroxide names and physical properties included in the Organic peroxide can be referred to in Jose Sanchez and Terry N.Myers, "Organic Peroxides", Kock-Oerson encyclopedia of Chemical Technology, fourth edition, volume 18 (1996). Exemplary dialkyl peroxides include, but are not limited to, dicumyl peroxide and the like; peroxydicarbonates include, but are not limited to: di (2-phenoxyethyl) peroxydicarbonate; bis (4-tert-butyl-cyclohexyl) peroxydicarbonate; dimyristyl peroxydicarbonates; dibenzyl peroxydicarbonate; and di (isobornyl) peroxydicarbonates, and the like. Cyclic ketone peroxides include, but are not limited to: cyclohexanone peroxide, and the like.
The fourth layer is a peelable layer, and the main body packaging material needs to be peeled off before the terminal use, so that the third layer of the rest main body packaging material is completely exposed in the air, namely, begins to shrink; the shrinkage rate under the condition of contacting air is more than 70 percent.
The content of the maleic anhydride grafted homo-polypropylene in the fourth layer is 20 wt.% to 60 wt.%, and the content of the oxygen-blocking or absorbing component is 40 wt.% to 80 wt.%.
For example, the maleic anhydride grafted homo-polypropylene in the fourth layer is present in an amount of 40 wt.%, and the oxygen barrier or absorbing component is present in an amount of 60 wt.%; or the content of the maleic anhydride grafted homopolymerized polypropylene is 60 wt.%, and the content of the oxygen-blocking or oxygen-absorbing component is 40 wt.%.
Preferably, the thickness of the fourth layer is 10 microns to 50 microns; such as 20 microns or 30 microns.
Preferably, the polymer with oxygen barrier property is one or a combination of several of ethylene-vinyl alcohol copolymer (EVOH), Polyamide (PA), polyvinyl alcohol copolymer (PVOH), polyvinylidene chloride (PVDC) and polyvinyl alcohol (PVA).
Preferably, the blend of the polymer with oxygen absorption property and the additive is one or a combination of more of natural rubber/ferrous catalyst ferrite, high-density polyethylene/mica or talcum powder, high-density polyethylene/nano zinc dioxide and EVA/dopamine modified rosin resin.
Preferably, the ferrous salt of the iron-based catalyst is ferrous sulfate or ferrous chloride.
Preferably, the mass ratio of the polymer with oxygen absorption property to the additive is (98-100) to (2-1). Such as 100:1 in the examples.
In a second aspect, the present invention provides a process for preparing the above coextruded shrinkable film, comprising the steps of:
respectively blending the raw materials of each layer;
and carrying out extrusion blow molding on the blended raw materials on a four-layer co-extrusion blow molding machine to obtain the co-extrusion shrinkable film.
Preferably, the extrusion temperature is 180-200 ℃, the film blowing temperature is 200-220 ℃, the cooling mode is water cooling, and the cold water temperature is 5-15 ℃;
the extrusion speeds of the first layer, the second layer, the third layer and the fourth layer are respectively as follows: 20-30rpm/min, 80-85rpm/min, 40-45rpm/min and 30-35 rpm/min. As will be readily appreciated by those skilled in the art, the base rate can be adjusted accordingly for a particular production run.
A third aspect of the present invention provides a portable infusion bag comprising:
the transparent bag body is used for placing a set of infusion device; the infusion device comprises an infusion bag provided by the first aspect of the invention;
the hook is arranged on the inner side of the top of the transparent bag main body and used for hanging the infusion bag;
and the through hole is arranged at the bottom of the transparent bag main body and is used for extending out a hose of an infusion apparatus.
When the infusion bag is used, the infusion device is placed in the transparent bag main body, the infusion bag is hung on the hook, the hose of the infusion device extends out through the through hole, the outermost layer of the co-extruded shrinkable film in the infusion bag is peeled off, the rest main body packaging material is fully exposed in the air, namely, the shrinkage is started, the liquid medicine is output, and the medical staff connects the infusion device to the body of a patient to start infusion; in the process, the patient can carry the portable transfusion bag to walk, go to the toilet and the like; and the condition of the liquid in the infusion bag can be observed at any time; the shrinkage rate of the subject packaging material of the infusion bag is more than 70% under the condition of contacting with air, so that the internal packaging preparation is ensured to be infused into the body under the external force of extrusion.
Preferably, the portable infusion bag further comprises a lifting handle arranged on the outer side of the top of the transparent bag main body, and the lifting is convenient. The lifting handle can be hung on the original movable hook at the hospital end and also can be lifted in the hand, so that the patient can move freely.
Preferably, the portable infusion bag further comprises braces arranged on the outer side face of the transparent bag main body, so that double shoulders or single shoulders can be conveniently carried. The portable transfusion bag can be carried on the back of a patient or an attendant through the braces, so that the patient can conveniently move, go to the toilet and the like.
Preferably, the transparent bag body is rigid or semi-rigid.
Preferably, the transparent bag main body is made of materials such as rigid polyvinyl chloride (PVC), Polyurethane (PU), polypropylene (PP), Polyethylene (PE) and the like.
Preferably, the light transmittance of the transparent bag body is more than or equal to 75%.
Preferably, the transparent bag body is in a rectangular parallelepiped shape, and as is readily understood by those skilled in the art, the shape thereof may be any shape suitable for carrying or carrying.
The infusion bag can be spontaneously contracted in the air, the extruded medicine is infused at a constant speed, an external power source is not needed, and the infusion bag integrates the advantages of environmental protection, energy conservation and convenience. The portable infusion bag matched with the infusion bag is simple in structure and convenient to use, meets the requirements of patients on activities, toileting and the like in infusion, and ensures that the patients or nurses can observe the infusion process at any time; and the portable infusion bag can be reused without generating any additional medical waste.
Drawings
FIG. 1 is a schematic view of a preferred portable infusion bag of the present invention.
Description of reference numerals:
1-a transparent bag body; 2-hooking; 3-a handle; 4-a through hole; 5-carrying the belt.
Detailed Description
In order to more clearly illustrate the invention, the invention is further described below in connection with preferred embodiments. It is to be understood by persons skilled in the art that the following detailed description is illustrative and not restrictive, and is not to be taken as limiting the scope of the invention.
Example 1
This example provides a coextruded shrinkable film prepared by the process comprising the steps of:
1) the components used in the four-layer formula are physically blended according to the proportion, wherein:
the first layer formula is as follows: medical grade, radiation resistant co-polypropylene (PPR): 75 wt.%, SEBS elastomer: 25 wt.%, melting point of the co-polypropylene: at 126 ℃.
The formula of the second layer is as follows: medical grade, radiation resistant co-polypropylene (PPR): 45 wt.%, polypropylene elastomer: 20 wt.%, content of SEBS elastomer: 35 wt.%.
The third layer comprises the following components: medical grade, radiation resistant homopolypropylene (PPH): 60 wt.%, branched polyethylene EVA: 15 wt.%, oxygen crosslinkable unsaturated elastomer SBR: 24 wt.%, dicumyl peroxide 1 wt.%.
The fourth layer comprises the following components: maleic anhydride-grafted homo-polypropylene: 40 wt.%, EVOH with oxygen barrier properties: 60 wt.%.
2) Carrying out extrusion blow molding on the blended material on a four-layer co-extrusion blow molding machine, wherein the extrusion temperature is as follows: 195 ℃, the film blowing temperature is 210 ℃, the cooling mode is water cooling, and the cold water temperature is 7-10 ℃; the extrusion speed of each extruder of the first layer, the second layer, the third layer and the fourth layer is respectively as follows: 30rpm/min, 80rpm/min, 40rpm/min, 35 rpm/min.
3) The final thickness of the blown film is 230 μm, wherein the thicknesses of two, three and four layers are respectively: 30 microns, 130 microns, 40 microns, and 30 microns.
The peel strength of the fourth, third layer was measured to be 7.8N/mm according to standard ASTM D3330 using 25mm standard width bars; after sterilization by gamma ray of 20KGy, the yellow index change is 0.2; and (3) preparing a 100mL bag, filling the glucose injection, connecting an infusion apparatus, peeling off the fourth layer, opening an instillation passage, and enabling the membrane to start self-shrink, wherein the overall shrinkage rate of the membrane is 75%.
Example 2
This example provides a coextruded shrinkable film prepared by the process comprising the steps of:
1) the components used in the four-layer formula are physically blended according to the proportion, wherein:
the first layer formula is as follows: medical grade, radiation resistant co-polypropylene (PPR): 55 wt.%, SEBS elastomer: 45 wt.%, melting point of the co-polypropylene: 131 ℃.
The formula of the second layer is as follows: medical grade, radiation resistant co-polypropylene (PPR): 65 wt.%, polypropylene elastomer: 15 wt.%, content of SEBS elastomer: 20 wt.%.
The third layer comprises the following components: medical grade, radiation resistant homopolypropylene (PPH): 45 wt.%, branched polyethylene EMMA: 30 wt.%, oxygen crosslinkable unsaturated elastomer ABS: 23 wt.% cyclohexanone peroxide 2 wt.%.
The fourth layer comprises the following components: maleic anhydride-grafted homo-polypropylene: 60 wt.%, natural rubber/ferrous chloride blend with oxygen-absorbing properties (mass ratio 100: 1): 40 wt.%.
2) Carrying out extrusion blow molding on the blended material on a four-layer co-extrusion blow molding machine, wherein the extrusion temperature is as follows: the film blowing temperature is 205 ℃, the cooling mode is water cooling, and the cold water temperature is 7-10 ℃; the extrusion speed of each extruder of the first layer, the second layer, the third layer and the fourth layer is respectively as follows: 20rpm/min, 85rpm/min, 45rpm/min, 30 rpm/min.
3) The final thickness of the blown film is 220 μm, wherein the thicknesses of two, three and four layers are respectively: 10 microns, 140 microns, 50 microns, and 20 microns.
The peel strength of the fourth, third layer was 6.5N/mm as measured by standard ASTM D3330 using 25mm standard width bars; after sterilization by gamma ray of 15KGy, the yellow index change is 0; and (3) preparing a 100mL bag, filling the glucose injection, connecting an infusion apparatus, peeling off the fourth layer, opening an instillation passage, and starting self-contraction of the membrane, wherein the integral contraction rate of the membrane is 78%.
Example 3
This example provides a coextruded shrinkable film prepared by the process comprising the steps of:
1) the components used in the four-layer formula are physically blended according to the proportion, wherein:
the first layer formula is as follows: medical grade, radiation resistant co-polypropylene (PPR): 95 wt.%, SEBS elastomer: 5 wt.%, melting point of the co-polypropylene: 122 ℃.
The formula of the second layer is as follows: medical grade, radiation resistant co-polypropylene (PPR): 30 wt.%, polypropylene elastomer: 30 wt.%, content of SEBS elastomer: 40 wt.%.
The third layer comprises the following components: medical grade, radiation resistant homopolypropylene (PPH): 55 wt.%, branched polyethylene EBA: 20 wt.%, oxygen crosslinkable unsaturated elastomeric polybutadiene rubber: 25 wt.%, 2, 5-bis (cumylperoxy) -2, 5-dimethylhexane 0.5 wt.%.
The fourth layer comprises the following components: maleic anhydride-grafted homo-polypropylene: 40 wt.%, natural rubber/ferrous sulfate blend with oxygen-absorbing properties (mass ratio 98: 2): 60 wt.%.
2) Carrying out extrusion blow molding on the blended material on a four-layer co-extrusion blow molding machine, wherein the extrusion temperature is as follows: the temperature of 180 ℃, the film blowing temperature is 210 ℃, the cooling mode is water cooling, and the temperature of cold water is 10 ℃; the extrusion speed of each extruder of the first layer, the second layer, the third layer and the fourth layer is respectively as follows: 20rpm/min, 85rpm/min, 45rpm/min, 30 rpm/min.
3) The final thickness of the blown film is 230 μm, wherein the thicknesses of two, three and four layers are respectively: 15 microns, 140 microns, 55 microns, and 20 microns.
The peel strength of the fourth, third layer was 4.5N/mm as measured by standard ASTM D3330 using 25mm standard width bars; after sterilization by gamma ray of 25KGy, the yellow index change is 0.2; and (3) preparing a 100mL bag, filling the glucose injection, connecting an infusion set, peeling off the fourth layer, opening an instillation passage, and enabling the membrane to start to shrink by itself, wherein the integral shrinkage rate of the membrane is 82%.
Example 4
The present embodiment provides a portable infusion bag as shown in fig. 1.
A rectangular transparent bag main body 1 is made of hard PVC, the thickness of the bag wall is 4mm, and the light transmittance reaches 88%; the outer side of the top of the transparent bag main body 1 is provided with a handle 3, the back part is provided with a back strap 5, and the inner side of the top is provided with two hooks 2 for hanging and containing infusion bags. An infusion preparation packaged by a liquid medicine bag made of the four-layer co-extrusion shrinkable film in the embodiment 1 is hung on the hook 2, one end of an infusion apparatus is pricked on a sealing cover of the liquid medicine bag, and the other end of the infusion apparatus penetrates out of a through hole 4 in the bottom of the transparent bag main body 1. Tearing off the stripping layer on the outermost layer of the bag, enabling the bag to shrink so that the drip cup and the infusion tube of the infusion apparatus are filled with the liquid medicine, then closing the flow rate regulator, and pricking the injection needle on the patient. Opening the flow rate regulator, adjusting the proper infusion speed in coordination with the contraction of the bag, and starting infusion; the self-shrinkage rate of the bag reaches 75%, and the liquid medicine can be completely extruded out of the bag and can be completely dripped. The portable infusion bag can be hung on an original movable hook at a hospital end, can be carried on the back of a patient or an attendant, and can also be lifted in the hand, so that the patient can move freely.
Example 5
The present embodiment provides a portable infusion bag as shown in fig. 1.
A rectangular transparent bag main body 1 is made of polyurethane, the thickness of the bag wall is 3.5mm, and the light transmittance reaches 93%; the outer side of the top of the transparent bag main body 1 is provided with a handle 3, the back part is provided with a back strap 5, and the inner side of the top is provided with two hooks 2 for hanging and containing infusion bags. An infusion preparation packaged by an outer bag made of the four-layer co-extrusion shrinkable film in the embodiment 3 is hung on the hook 2, one end of an infusion apparatus is tied on a sealing cover of the liquid medicine bag, and the other end of the infusion apparatus penetrates out of a through hole 4 in the bottom of the transparent bag main body 1. Tearing off the stripping layer at the outermost layer of the outer wrapping bag, enabling the bag to shrink so that the drip cup and the infusion tube of the infusion apparatus are filled with the liquid medicine, then closing the flow rate regulator, and pricking the injection needle on the patient. Opening the flow rate regulator, adjusting the proper infusion speed in coordination with the contraction of the bag, and starting infusion; the self-shrinkage rate of the bag reaches 82%, and the liquid medicine can be completely extruded out of the bag and can be completely dripped. The portable infusion bag can be hung on an original movable hook at a hospital end, can be carried on the back of a patient or an attendant, and can also be lifted in the hand, so that the patient can move freely.
It should be understood that the above-mentioned embodiments of the present invention are only examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention, and it will be obvious to those skilled in the art that other variations or modifications may be made on the basis of the above description, and all embodiments may not be exhaustive, and all obvious variations or modifications may be included within the scope of the present invention.
Claims (10)
1. An infusion bag, characterized in that the primary or secondary packaging of the infusion bag is made of a co-extruded shrinkable film;
the coextruded shrinkable film comprises, from inside to outside, four film layers:
the first layer comprises 50 wt.% to 95 wt.% of a co-polypropylene and 5 wt.% to 50 wt.% of a SEBS elastomer;
the second layer comprises 30 wt.% to 65 wt.% of a co-polypropylene, 15 wt.% to 50 wt.% of a polypropylene elastomer, and 10 wt.% to 40 wt.% of SEBS;
the third layer comprises 40 wt.% to 70 wt.% of homopolypropylene, 10 wt.% to 30 wt.% of branched polyethylene, 20 wt.% to 50 wt.% of an oxygen crosslinkable unsaturated elastomer, and 0.5 wt.% to 2 wt.% of an organic peroxide;
the fourth layer comprises 20 wt.% to 60 wt.% of maleic anhydride grafted homopolypolypropylene and 40 wt.% to 80 wt.% of an oxygen barrier or oxygen absorbing component; the oxygen-blocking or oxygen-absorbing component is a polymer with oxygen-blocking property or a blend of the polymer with oxygen-absorbing property and an additive.
2. The infusion bag according to claim 1, wherein the raw materials of the four film layers of the co-extruded shrinkable film are melted by an extruder and then co-extruded to prepare a film; wherein the fourth layer, the outermost layer, is peelable from the third layer;
preferably, the peel strength is not more than 10N/15 mm; the shrinkage rate of the peeled main body film is more than 70 percent.
3. The infusion bag according to claim 1, wherein the co-polypropylene in the first and second layers and the homo-polypropylene in the third layer are both medical grade and have radiation resistance, and the change of the yellowness index before and after radiation is less than or equal to 1 under the radiation condition of 15-25 KGy dose;
preferably, the melting point of the co-polypropylene in the first layer is from 120 ℃ to 135 ℃.
4. The infusion bag of claim 1, wherein the first layer has a thickness of 10-40 microns;
preferably, the thickness of the second layer is from 100 microns to 200 microns;
preferably, the thickness of the third layer is 15 microns to 70 microns;
preferably, the thickness of the fourth layer is 10 microns to 50 microns.
5. The infusion bag according to claim 1, wherein the branched polyethylene is one or a combination of two of ethylene-vinyl acetate copolymer, ethylene-methyl methacrylate copolymer, ethylene-ethyl acrylate copolymer and ethylene-butyl acrylate copolymer;
preferably, the oxygen crosslinkable unsaturated elastomer is one or a combination of two of nitrite rubber, acrylonitrile-butadiene-styrene copolymer, styrene butadiene rubber, styrene-butadiene-styrene block copolymer, polybutadiene rubber, styrene-isoprene-styrene block copolymer, halogenated acrylonitrile butadiene, natural rubber, synthetic polyisoprene rubber, chloroprene rubber, polychloroprene, bromobutyl rubber and chlorobutyl rubber;
preferably, the organic peroxide is a dialkyl peroxide, diperoxyketal, monoperoxycarbonate, cyclic ketone peroxide, diacyl peroxide, organic sulfonyl peroxide, peroxyester, or peroxydicarbonate;
preferably, the polymer with oxygen barrier property is one or a combination of several of ethylene-vinyl alcohol copolymer, polyamide, polyvinyl alcohol copolymer, polyvinylidene chloride and polyvinyl alcohol.
6. The infusion bag according to claim 1, wherein the blend of the polymer with oxygen absorption property and the additive is one or a combination of more of natural rubber/ferrous catalyst ferrite, high density polyethylene/mica or talcum powder, high density polyethylene/nano zinc dioxide and EVA/dopamine modified rosin resin;
preferably, the ferrous salt of the iron-based catalyst is ferrous sulfate or ferrous chloride;
preferably, the mass ratio of the polymer with oxygen absorption property to the additive is (98-100) to (2-1).
7. A portable infusion bag, comprising:
the transparent bag body is used for placing a set of infusion device; the infusion device comprising an infusion bag according to any of claims 1-6;
the hook is arranged on the inner side of the top of the transparent bag main body and used for hanging the infusion bag;
and the through hole is arranged at the bottom of the transparent bag main body and is used for extending out a hose of an infusion apparatus.
8. The portable infusion bag of claim 7, further comprising a handle disposed outside the top of the transparent bag body;
preferably, the portable infusion bag further comprises a strap arranged on the outer side surface of the transparent bag main body.
9. The portable infusion bag of claim 7, wherein the transparent bag body is rigid or semi-rigid;
preferably, the transparent bag main body is made of rigid polyvinyl chloride, polyurethane, polypropylene and polyethylene.
10. The portable infusion bag of claim 7, wherein the light transmittance of the transparent bag body is greater than or equal to 75%;
preferably, the transparent bag body has a rectangular parallelepiped shape.
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