JP2592416C - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION TECHNICAL FIELD The present invention relates to a medical container, and more particularly, to a medical container suitable for dissolving or diluting a contained drug and supplying (administering) it to a living body. B. Prior art To supply (administer) high-calorie infusions to living organisms (Total Perenteral Natrition) or to administer enteral infusions to living organisms (Enteral Nutrition) to provide nutrition before and after surgery and to ensure nutrition of the entire digestive system. Is made. In particular, the administration of enteral infusion is a necessary treatment for promoting the recovery of health and speeding rehabilitation of patients with gastrointestinal dysfunction and patients who have undergone major surgery. However, since various components are contained in the infusion, the reaction between the components, deterioration, and activity decrease with the lapse of time, and the value thereof decreases. Therefore, a solid, especially a powdered nutrient or a concentrated infusion is prepared, and is dissolved in water immediately before use to obtain an infusion. Taking an enteral infusion as an example, conventionally, an enteral nutrient is first taken out of a package, supplied with tap water in a bottle or a bowl, stirred, dissolved, and used as an infusion. Next, the infusion was placed in an infusion bottle or an infusion bag, and the infusion was administered to the living body in a usual manner close to infusion. In such a method, the above-described dissolution and transfer of the infusion to an infusion bottle or infusion bag and other steps are performed in the air, and various bacteria originally contained in tap water often mix into the infusion, and the infusion is performed at room temperature. It is known that when used, the propagation of various bacteria becomes remarkable from about 8 hours after the dissolution. Therefore, in normal facilities,
In many cases, the working life of the infusion solution after dissolution is limited to 8 hours or less. In addition, since enteral infusion is used for patients whose physical strength has not been sufficiently restored, the propagation of various bacteria not only shortens the pot life of the infusion but also causes complications such as diarrhea. This can cause problems. In order to solve the above-mentioned problems, various bags have been proposed in which a medical drug or a concentrated infusion is stored, and sterile water is supplied into the bag to dissolve or dilute the solution to make an infusion. For example, JP-A-59-46971, JP-A-46972, and JP-A-778862 each have a means for injecting a liquid (for example, a cap) into a graduated container, and inject water from the outside via this. Disclosed is a container that is dissolved or diluted to form an infusion solution and administered to a living body. These are very natural ideas, but the containers themselves must be transparent, and in the case of long-term preservation of drugs, etc., it is inevitable that the contents will be deteriorated by light, etc. Considering time, it can only be used in very limited cases and is not satisfactory. Further, Japanese Patent Laid-Open No. 58-16946
No. 5 discloses a container using a laminate film with an aluminum foil and using an elastic plug at an outlet. This container has light-shielding properties and is considered to be excellent in storage stability as compared with the above-mentioned example, but it is presumed that the contents are not sufficiently visible from the outside and the infusion is consumed during administration. It is difficult to detect and is not practical as an infusion administration bag. JP-A-56-101345 discloses a container provided with a light-shielding cover as a container that allows the contents to be seen from the outside and has a light-shielding property. If it is easy to see, the shading will be incomplete. Further, as disclosed in Japanese Patent Application Laid-Open No. 61-268257, there is an example in which a transparent portion is provided in a part of a light-shielding bag to check the level of the contents. Therefore, it is not possible to sufficiently check the state of dissolution or dilution of the drug or the like and the level of the infusion solution, and it is extremely inconvenient in practical use as a container that also serves as packaging, dissolving and administration of a medical drug. C. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and shields a stored medical drug from light to reliably prevent its deterioration. It is intended to provide a medical container that can be sufficiently observed. D. Configuration of the Invention The present invention provides a bag-shaped medical container for containing a medical agent, which has a transparent or translucent inner layer forming a container body, and has a light shielding property fixedly integrated with the inner layer. A laminated structure having an intermediate layer and a gas shielding outer layer fixedly integrated with the intermediate layer is integrally formed on substantially at least one surface of the container, and the intermediate layer Is attached to the inner layer so as to be peelable and re-adherable together with the outer layer while covering the entire surface of the inner layer. E. Examples Hereinafter, examples of the present invention will be described. FIG. 1 is a cross-sectional view of a 1-liter infusion bag, and FIG. 1A shows a state in which a nutrient, which is a solute of enteral infusion, is contained in the bag. The bag 2A has a transparent layer 31 formed by laminating a transparent polyethylene (PE) film and a transparent polyethylene terephthalate (PET) film, a light shielding layer 32 made of aluminum foil, and a PET having gas shielding properties from the inside to the outside. The outer layer 33 of the film has a laminated structure in which the nutrient powder ENM is accommodated. An enteral infusion inducing section 35 is provided at the lower end of the bag 2A. This infusion deriving unit will be described later in detail. On one side of the bag 2A, the transparent layer 31 and the light shielding layer 32 are peelably and re-adherably adhered to each other, and pass through the state shown in FIG. 1 (b) and the shielding layer 32 and the outer layer as shown in FIG. 33 is peeled off from the transparent layer 31 to leave the transparent layer 31 on only one side, so that the enteral infusion ENL in which the nutrient is dissolved in water can be observed from outside in a wide range. FIG. 2 is a cross-sectional view showing a procedure for supplying sterile water in the bag 2A to dissolve nutrients contained therein, forming an enteral infusion, and supplying the solution to the outside. As shown in FIG. 2 (a), a state is shown in which sterile water W, which is a solute, is supplied into the bag 2A by piercing the injection needle 37 into the infusion outlet 35, and the nutrient ENM is being dissolved. FIG. 2 (b) shows a state in which all the nutrients are dissolved in sterile water to form an enteral infusion ENL. FIG. 2C shows the light shielding layer 32 and the outer layer 3 on one side as shown in FIG.
3 shows a state in which 3 is peeled off from the bag 2A and the enteral infusion ENL inside is supplied to the living body (not shown) from the injection needle 37. At the time of enteral infusion, the entire surface or almost the entire surface of one side of the bag is only the transparent layer 31, so that the state in which the enteral infusion ENL is consumed and reduced can be easily and accurately observed from the outside. The structure is simple and easy to manufacture. In the states shown in FIGS. 1 (a), 2 (a) and 2 (b), the light shielding layer 32 made of aluminum foil and the outer layer 33 having a gas shielding property prevent air and light from entering the inside, The nutrient ENM and the enteral infusion ENL are not deteriorated by air or light, and particularly the nutrient ENM can be stored for a long time. In the state of FIGS. 1 (b), (c) and 2 (c), since only one side is the transparent layer 31, air or light enters the enteral infusion ENL. Since the administration time of the enteral infusion by the bag is not long, there is substantially no alteration of the enteral infusion by air or light during this time. FIG. 3 shows an infusion bag according to another example, wherein FIG. 3 (a) is a front view, and FIG. 3 (b) is a sectional view taken along line III-III of FIG. 3 (a). The layer configuration of the infusion bag 2B of FIG. 3 is not different from that of the infusion bag 2A of FIGS. 1 and 2, and the common parts are denoted by the same reference numerals. The bag 2B has an envelope shape, and the infusion lead-out portion 35 is provided near the lower edge. In the bag 2B, a hanging hole 2Ba is provided on the upper end side so that the bag 2B can be hung when used. In FIG. 3 (b), a state where the light-shielding layer 32 and the outer layer 33 are peeled off is shown by a virtual line. A region 34 indicated by a broken line in FIG. 3 (a) is a region where the laminates on both sides are adhered to each other, and the nutrient ENM is stored inside the region 34. In order to adhere the light-shielding layer 32 on one side together with the outer layer 33 so as to be releasable from the transparent layer 31, the light-shielding layer 32 may be adhered on the entire surface of one side, or may be adhered on the entire area or a part of the area 34. In addition, a scale 31a can be provided on the transparent layer 31 on the side where it can be peeled off. This scale may be provided with a number or the like, but it is only necessary to insert a mark as a guide for knowing the amount of the contents. The scale 31 can be provided by an appropriate method such as applying a concave or convex to printing, molding, or the like on the transparent layer 31 or attaching a printed film. As a material of the transparent layer 31, polyethylene, polypropylene, polyester,
Any of polyvinyl alcohol, ethylene propylene copolymer, ethylene vinyl acetate copolymer, polyvinylidene chloride film, etc. may be used, but a gas permeable material, a heat sealable material is selected according to the purpose, and a single film In addition, a laminate film of a different polymer is used. As a material of the light shielding layer 32,
A film made of a substance that does not substantially transmit light, such as a metal foil of aluminum or the like, a laminated film of a metal foil and a polymer, or a polymer film in which a pigment is kneaded can be used. In addition, a film made of a material that does not allow only light having a wavelength harmful to an object to be accommodated can be substantially treated as a light-shielding film. As a material of the outer layer 33, for example, polyvinylidene chloride, polyvinyl alcohol, or the like may be used in addition to the PET. FIG. 4 is an enlarged sectional view (FIGS. 1 and 2) showing the structure of the enteral infusion inducing section 35 of FIG.
The enteral infusion inducing section 35 in the figure has the same structure). A tapered rigid tubular body 35a having a stepped portion on the outer peripheral surface protrudes from the inside of the outer layer 33 to the outside.
A rubber plug 35c fits into the inside a, and a cap 35b having a through hole is fitted over the tubular body 35a so as to cover the plug 35c to seal the inside. Then, a syringe needle 37 shown by a virtual line is pierced into the rubber plug 35c, penetrated to the inside to supply sterile water to the inside, and to allow the enteral infusion in the inside to be drawn out to the outside. FIG. 5 shows an enteral infusion inducing section according to another example, in which a tubular enteral infusion inducing section 36 extends at the bottom of the bag, and its distal end 36a is closed. At the position, for example, scissors are used to cut and remove the vicinity of the distal end of the infusion inducing portion 36a using scissors, so that sterile water can be supplied and the infusion can be derived. In addition to the above, for example, the infusion inducing section can be provided with a button, a cap or the like, and can have an appropriate structure that can supply and deliver a fluid in an aseptic state and have a secure seal. Then use it. Next, specific examples will be described. The infusion bag 2B of FIG. 3 was prepared as follows. As the light shielding layer 32, a laminated film of a 10 μm-thick polyester film and a 10 μm-thick aluminum foil was used. The outer layer 33 has a thickness of 60
It is a polyethylene film of μm, and the layers 32 and 33 are adhered to each other to form an integrated laminate. The transparent layer 31 has a polyester film having a thickness of 10 μm and a thickness of 50 μm.
m, a laminated film with a polyethylene film was used. The transparent layer 31 on one side and the light-shielding layer 32 are bonded by heat fusion so that they can be peeled off (peel off), and the other layers are bonded by a usual method. The scale 31a was provided on the transparent layer 31 by printing. Near the lower end of the bag 2B, an infusion outlet 35 shown in FIG. 4 is provided. FIG. 6 shows an infusion supply device 1 and an infusion conducting device 2 each having the infusion bag 2B of FIG.
FIG. 2 is a schematic diagram showing a state in which No. 1 is combined. A nutrient (a solute component of enteral infusion) is sealed in the infusion bag 2B, and the injection needle 37 is pierced into a rubber stopper 35c (see FIG. 4) of the infusion inducing section 35, and the injection needle 37
Is connected to the first infusion conduit 10. Nutrient ENM in powder (Fig. 3 (
b)) is composed of amino acid sources such as amino acids and polypeptides, sugars, vitamins and the like. The first infusion conduit 10 is connected to a syringe (syringe) 16 via a check valve 11, a sterilization filter 13, a conduit 14, and a connector 15. A connector 12 indicated by a virtual line may be provided between the check valve 11 and the sterilization filter 13 so as to facilitate the connection. A filter having a pore size of 0.22 μm to 0.8 μm (trade name: Ibex-II) can be preferably used as the sterilization filter 13. The first infusion conduit 10 is provided with a branch pipe 10a branching therefrom. The above components constitute the infusion supply device 1. The enteral infusion ENM supplied from the infusion supply device 1 is administered to the small intestine (not shown) via the infusion conducting device 21 and the catheter 27. The infusion conducting device 21 has a drip tube 22, a flow controller (Klemme) 24, and a second infusion conduit 25 connected in order, and a luer lock connector 23 is attached to a tip of the second infusion conduit 25. is there. The infusion supply device 1 is set as follows. The syringe 16, the connector 15, the conduit 14, the sterilization filter 13, (preferably the connector 12), the check valve 11 and the first infusion conduit 10 are sequentially connected, and the first infusion conduit 10 and the bag 2 </ b> B are connected with an injection needle. A connection 37 is made via the infusion outlet 35. As described above, the infusion supply device 1 is easily set. Next, the branch tube 10 a of the first infusion conduit 10 is connected to the drip tube 22 using the connector 26. Next, the second infusion conduit 25 is connected to the nasal catheter 27, which has been inserted so that the distal end portion reaches the small intestine of the patient in advance, by a normal luer lock connector 23. Thus, the infusion supply device 1, the infusion conducting device 21, and the nasal catheter 27 are connected. The procedure of infusion administration is as follows. Water (tap water may be used) W as a solvent is supplied from the syringe 16 into the bag 2B. The germs are removed from the water W by the germicidal filter 13, cleaned, and supplied to the bag 2B via the first infusion conduit 10. When the water W is supplied into the bag 2B, as shown in FIG. 3 (b), the water W supplied into the bag 2B dissolves the nutrient ENM, and FIG. 2 (a), (b) The nutrient ENM in the bag 2B becomes the enteral infusion ENL in the same manner as described above. This enteral infusion ENL is in a digested or semi-digested state, and is in a state where it can be absorbed into the body from the small intestine as it is. The dissolved infusion solution becomes the enteral infusion ENL, is supplied into the drip tube 22 via the first infusion conduit 10 and its branch tube 10a, and when a predetermined amount is stored in the drip tube 22, the flow rate is adjusted. It is introduced into the small intestine (not shown) via the device 24, the second infusion conduit 25, and the nasal catheter 27. The enteral infusion ENL is filtered by the check valve 11 into the sterilization filter 1.
Backflow to 3 is prevented. At the time of administration of the enteral infusion ENL, the light-shielding layer 32 and the outer layer 33 on one side are peeled off the bag 2B as shown by a virtual line, and the surface is made only the transparent layer 31. This state is similar to the state shown by the imaginary line in FIG. 3 (b) or the state shown in FIG. 2 (c), and the state in which the enteral infusion ENL is consumed and decreased is observed in a wide area from the outside. Thus, the next infusion bag can be prepared before the enteral infusion ENL is consumed. Moreover, since the exposed transparent layer 31 is provided with the scale 31a, it is possible to accurately predict the time of replacement with the next bag in terms of time. Further, it is possible to prevent the administration in a state where the insoluble matter remains in the infusion. Enteral infusion ENL is administered to a patient as described above.
Since M is stored in a sealed state in the bag 2B and shielded from air and light, it can be stored for a long time without deterioration. Further, since the nutrient ENM is dissolved in water sterilized by the sterilization filter 13 immediately before use and provided as an enteral infusion ENL for administration, it does not substantially come into contact with the atmosphere and is administered. Enteral infusion ENL is maintained in a substantially sterile state without causing troubles caused by bacteria,
The pot life also increases. In the above example, the light-shielding layer and the outer layer are peeled off from the transparent layer on one side of the infusion bag, but the transparent layer may be exposed on both sides as described above. Further, since the transparent layer is a layer for allowing the inside to be observed, it may be translucent. Further, the shape of the infusion bag and the like may be an appropriate shape. In addition to administration of enteral infusion to the small intestine, it can be similarly used for administration of high-calorie infusion to the central vein directly connected to the heart. It can also be applied to infusion administration to living organisms other than. F. Effect of the Invention As described above, in the medical container according to the present invention, the invasion of air is reliably prevented by the gas-shielding outer layer, and the deterioration of the contained object (for example, an infusion solution) due to air is reliably prevented. . Furthermore, since at least one surface of the container has a structure in which the light shielding layer can be peeled off from the transparent or translucent layer, the container (eg, infusion solution) can be passed through the transparent or translucent layer by the peeling. It can be observed in a wide area from outside. As a result, it is possible to easily and surely know the amount of the object to be stored and other conditions, and to take appropriate processing according to the conditions. Further, the structure is simple and the manufacture is easy. In addition, since the light shielding layer is integrally formed on substantially the entirety of the at least one surface of the container, the object (medical drug) is reliably shielded from light on this surface, and Deterioration of the object can be reliably prevented, and the object can be stored for a long time.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows an embodiment of the present invention. FIG. 1 shows an infusion bag, and FIG. 1 (a) is a cross-sectional view of an infusion bag containing nutrients. FIG. 2 (b) is a cross-sectional view showing a state where the light-shielding layer is being peeled off from the infusion bag containing the enteral infusion, FIG. 2 (c) is a cross-sectional view showing a state where the light-shielding layer is peeled off from the infusion bag, and FIG. FIG. 1A shows another state of the infusion bag of FIG. 1, wherein FIG. 1A is a cross-sectional view of a state in which the nutrient is being dissolved in water, and FIG. FIG. 3C is a cross-sectional view showing a state in which enteral infusion is supplied, FIG. 3 is a cross-sectional view showing another example of an infusion bag, FIG. ) Is a cross-sectional view taken along line IIIb-IIIb of FIG. 3A, FIGS. 4 and 5 are cross-sectional views of the transfusion lead-out section, respectively, and FIG. It is a schematic diagram of a state of connecting the location. In addition, in the code | symbol shown in drawing, 1 ... Infusion supply apparatus 2A, 2B ... Infusion bag 10, 25 ... Infusion conduit 21 ... Infusion conduction apparatus 27・ ・ ・ ・ ・ ・ Catheter 31 ・ ・ ・ ・ ・ ・ Transparent layer 31a ・ ・ ・ ・ ・ ・ Scale 32 ・ ・ ・ ・ ・ ・ Light shielding layer 33 ・ ・ ・ ・ ・ ・ Outer layers 35, 36 ・ ・ ・ ・ ・ ・Infusion deriving section 37 Injection needle ENM Nutrient W Water ENL Enteral infusion.

Claims (1)

[Claims] 1. In a bag-shaped medical container for storing a medical agent, a transparent or translucent inner layer forming a container body, a light-shielding intermediate layer fixed to and integrated with the inner layer, and the intermediate layer A laminated structure having a gas shielding outer layer fixedly integrated with the container is integrally formed on substantially at least one surface of the container, and the intermediate layer covers the entire surface of the inner layer. Peelable with the outer layer in a covered state; and
A medical container, which is re- adherably attached to the inner layer.