JP2000510080A - Dispenser unit, method of manufacturing the same, and method of using the same - Google Patents

Abstract

(57) [Summary] The dispenser unit has a flexible bag, a connecting portion (10, 11), and a non-flexible hard portion (20). The joint has an inner layer (11) weldable to the rigid part and a polymeric outer layer (10) weldable to the inner material of the flexible bag. The inner material (30) of the flexible bag and the outer material of the joint (10) are the same, and they are heat sterilizable joined. The method for manufacturing the dispenser unit includes a step of co-extruding a multilayer bag material and a step of sealing the bag material, sealing the multilayer joint, and sealing the hard portion. Also disclosed is a method of use as a dispenser unit for dispensing liquids, in particular for human or animal medical purposes or in the food industry, especially solutions containing water.

Description

The present invention relates to a flexible polymer bag, a non-flexible rigid portion, an inner layer welded to the rigid portion and the inner material of the flexible bag. A dispenser unit having a joint having a polymeric outer layer welded to the dispenser unit, a method of producing the same, and a method of using the same. Such dispenser units are used for containing and dispensing liquids, in particular made of a transparent polymer, such as a polyolefin material, heat-sterilizable and physiologically safe bags, and at least one rigid body. And the hard portion is sterilely connected to the bag material via a connecting piece, and the welded joint between the bag and the hard portion easily withstands a (steam) sterilization temperature of at least 121 ° C. is there. The bag should be transparent so that any changes, such as liquid settling, cloudiness, etc., are directly visible. Such bags are used, for example, in the medical field, such as dialysate bags, plasma bags, blood bags, but are also optionally suitable for other water-containing solutions, such as drinks. Thousands of similar flexible containers of the prior art that are used are made primarily from flexible PVC. PVC is preferred because it can be easily and firmly adhered to polycarbonate, a common material for rigid parts, and also forms a transparent and flexible film. However, PVC has become undesirable for a variety of reasons. In order to provide the required physical properties of flexibility, PVC must include a plasticizer. These plasticizers, such as diisooctyl phthalate, have a tendency to move out of the PVC and into the liquid contained in the bag. Thus, if such PVC bags are used for an extended period of time, patients who rely on dialysis for an extended period of time may absorb several grams of plasticizer. This is a serious physiological drawback and can cause permanent damage to the patient. Beyond this, PVC has many problems for disposal to generate chlorine compounds when burned, and therefore attempts have been made to replace halogen-free compounds. However, to date, other materials at commercially viable cost have just the benefit of having the favorable properties of PVC: excellent waterproof vapor properties and high waterproofness, being transparent and weldable without problems. Was very difficult to achieve. For example, after a bag of a polyolefin such as polyethylene is welded to a rigid portion made of, for example, polycarbonate, by a tubular bonding piece that is a copolymer of polyethylene and vinyl acetate, the composite is cross-linked by radiation, It can be seen from the detailed description of the invention of German patent DE 32 47 294 A1 that a joint between the PE of the joint and the PE of the bag is produced which resists sterilization. In the uncrosslinked state, the copolymer of polyethylene and vinyl acetate begins to flow at the sterilization temperature. Therefore, all parts need to contain the cross-linking material. Because the weld seam between the joint and the polycarbonate part is created first, then the vinyl acetate and polyethylene copolymer are crosslinked so that the joint withstands high sterilization temperatures and the bag withstands sterilization. is there. However, the radiation crosslinking is considerably more difficult and costly as all of the finished dispenser unit must be transported to the appropriate radiation source and handled there. Also in this prior art, the choice of bag material is very limited, since a polyolefin weldable to EVA containing polyolefin must always be used as the material inside the bag. Otherwise, joining with the PC part and joining with the inside of the bag cannot be guaranteed. A similar method can be found in the detailed description of the invention in German patent DE 3305365. The details of that invention disclose a PVC-free sterilizable bag having an outer layer of adhesive polyamide, usually PA66, and a medium density polyethylene as the inner layer. These bags are, except that the manufacturing process is very complicated, since the polyethylene does not contain plasticizer and is at least equal to a good quality PVC bag, and that the medium density polyethylene used is expensive. There are no physiological difficulties. The detailed description of the invention of European Patent EP 380 270 includes a tubular material for attaching to a patient or introducing additional material into a flexible bag, which can be optionally welded to the rigid part of the polycarbonate, Its outer surface is disclosed in the form of a three-layer tubular material that can be sealed to the polycarbonate by ultrasonic, microwave or heat. This sterilizable tube consists of an outer layer of polypropylene, ethylene propylene copolymer or ethylene propylene copolymer modified to thermoplastic elastomer, which can be sealed to polycarbonate, and ultra low density propylene, ethyl vinyl acetate copolymer. Coated, modified or unmodified ethylene methyl acrylate copolymer, polyvinylidene chloride, copolymer of ethyl vinyl acetate and modified ethyl vinyl acetate, mixture of ethyl vinyl acetate and ultra low density propylene, modified ethyl vinyl acetate And an intermediate layer that creates a flexible connection such as The inner layer should have a very heat resistant polymeric material, such as copolyester, polypropylene, ethylene propylene copolymer, polyurethane, PVC, or a mixture of copolyester and ethyl vinyl acetate. Preferably, the material of the hose is used which is cross-linked by a chemical cross-linking agent during co-extrusion or is radiation cross-linked to improve the temperature resistance (sterilizability) of the weld joint. You. Otherwise, the material will flow under sterile conditions without maintaining its properties. This known joint is designed such that the polycarbonate is joined to its outer surface and has a complex joining structure with a flexible bag. Thus, this is a liquid tube connectable to the polycarbonate part, rather than the joint, and it must of course be autoclavable. The detailed description of the invention of EP-A-564 231 proposes a co-extrusion joint for joining a flexible bag to a rigid part of polycarbonate, having a polyolefin polymer material with a melt flow index of about 12 as outer layer. Have been. The inner layer is joined here to an intermediate layer, for example made of SBS, which gives the joint flexibility. The inner layer is embodied as a tie layer containing ethyl vinyl acetate to ensure bonding to the polycarbonate. This device requires another re-crosslinking of the bag, for example by radiation, after the joints have been welded to it to make it a sterilizable device. From the detailed description of the invention of German patent DE 4472175 (Coster), it is clear that a multilayer foil having a polyamide or polyester layer as an outer layer in order to improve the mechanical strength, wherein polyethylene and polypropylene are attached to each other or to each other Flexible bags having an inner layer of polyethylene or polypropylene are known which are welded to a connecting tube having an outer layer of polyethylene, polypropylene, or the like, because they are easily weldable. The hard portion to be welded to the inner layer of the joint portion includes polyacetal. However, this device has the disadvantage that it is not heat sterilizable. The detailed description of the invention of International Patent WO 93/23108 (Baxter) addresses the problem of joints for flexible bags containing PVC, which bags are co-extruded into three layers. And an outer layer of a polypropylene copolymer / styrene / ethylene-butylene-styrene copolymer mixture and an inner layer of PVC. However, the use of PVC is often undesirable for the reasons mentioned above. From such a viewpoint, an object of the present invention is to join a multilayer bag having an inner layer of polyolefin to a hard part. The bags should be sterilizable and their manufacture should be very simple. This object is achieved by the features of claim 1. The present invention provides a dispenser unit according to the preceding claim, characterized by the following: co-extrusion of a multilayer bag material, co-extrusion of a multilayer joint, sealing of the bag material, sealing of the multilayer joint, and sealing of the hard portion. How to do it. The present invention relates to the use of any one of the above-mentioned dispenser units for liquids, especially water-containing liquids, or for medical or veterinary purposes, or for nutritional purposes, as claimed above. Related to It is advantageous for the coextrusion joint to have EVA-rich polyethylene as its inner layer and to be radiation crosslinked by itself before being sealed. Useful ideas are listed in the subclaims. For the rigid part, a polymer such as polycarbonate polyacetal or polyethylene is suitable. Polycarbonates that bond correspondingly to olefins that must be cross-linked, especially radiation cross-linked, are often used because only the inner layer of the bond needs to be suitable to ensure that they are bonded to the hard part, which is inexpensive and relatively inexpensive. During the production of the bag itself from a thermally stable polyolefin, only the joints can be subjected to complicated and expensive crosslinking operations. Therefore, it is no longer necessary for the bag to be provided with a joint beforehand, to contain EVA-rich polyethylene as an inner material of the bag and also as an outer layer of the joint, and to be transported to the irradiation facility by road or rail. Not necessary. Thus, only the joints have to be transported, which reduces production costs and environmental pollution. According to the present invention, the use of a multi-layer tube as the joint makes it possible to use polypropylene having a suitable and essentially high melting temperature (140-160 ° C.) as bag material. As a result, much higher sterilization temperatures can be used. This means that the bags in particular have no problem for steam sterilization, which can at the same time shorten the sterilization time. In particular, polypropylene multi-layer bags of the kind disclosed in the detailed description of the invention in German patent DE-A 1 904 4008.4 are particularly advantageous. This disclosure is fully embodied by the description therein and avoids duplication here. Steam sterilization does not cause the inner surfaces to stick together. That is, only by them enables safe heat sterilization. In the past, when polyethylene or PVC was used, if the inner layer of the bag was PVC or polyethylene, it was roughened to prevent the inner surfaces from sticking together. The embodiment according to the present invention uses a higher melting point plastic that does not need to be bonded to the polycarbonate, so that a roughening process can be avoided, and the upper bag is more transparent. It may be necessary to integrate an additional barrier layer into the bag foil. As a barrier layer, for example, ethylene vinyl alcohol (EVOH) can be used, which seals oxygen, nitrogen, CO ₂ and other gases very well. In addition, additional layers (such as polyethylene) can be coated with SiOx or aluminum oxide by thin-film technology. As disclosed in the prior art, it is of course also possible to use a polyamide / polyethylene blend film laminated as a bag, as before, but as before, but with a connection according to the invention in combination with other materials. For selection, the finished bag can also be subjected to radiation crosslinking. PVC, polyethylene, polypropylene, polyamides and their compounds, especially those containing thermoplastic elastomers such as SEBS compounds, or their multi-layer mixed films such as polyethylene / ethyl vinyl acetate, PA / polyethylene, polypropylene / SEBS etc. Is preferred for the flexible bag. It is advantageous if the bags are manufactured by coextrusion. However, it may require skilled personnel who are familiar with all production processes. The bond preferably has an inner layer that forms a heat-sterilizable bond with the polycarbonate, such as cross-linked polyethylene or PVC high in ethyl vinyl acetate, the inner layer being the liquid in the bag or the material thereof. And there is no actual contact, and as a result it is in this position and is therefore only used as a bonding material, so there is relatively no problem. The dispenser unit according to the present invention is capable of independently producing, by co-extrusion, a multilayer polymer joint in the form of a tube, for example, in which the outer material is weldable to the inner material of the bag and the inner layer is weldable to the outer material of the rigid part. At the same time, the sterilized polymer bag can be manufactured in a manner known per se, for example, if it is a multilayer bag or the like, by means of coextrusion. Here, the joint is optionally radiation crosslinked to make it sterilizable. Further, the rigid part is made of a material that can be welded to the inner material of the joint, and the rigid part is then welded to the joint welded to the inside of the bag, such as at normal sterilization temperatures. Creates a welded joint that can withstand high temperatures. Such a dispenser unit is particularly suitable for containing medical fluids such as artificial replenishing solutions, blood, plasma, dialysis fluids, and the like. With the use of the combination according to the invention of the bag, the joint and the rigid part, which is now required so that the polyolefin serves as the joint to the rigid part and can withstand the sterilization temperature, the complexities of the entire bag by radiation are increased. A special case of a dispenser unit having a hard part to avoid expensive and expensive cross-linking becomes possible. On the contrary, it is sufficient to crosslink the joint. This is because only that part has a cross-linked polyethylene layer high in ethyl vinyl acetate, which is required for secure attachment to the polycarbonate. It also makes it possible to avoid using special polyamide / polyethylene-containing films for multilayer film bags, including expensive medium-density polyethylene, which barely withstands a sterilization temperature of 121 ° C. Instead, the present invention allows the use of inexpensive, more heat-resistant and easy-to-handle olefins as the outer layer of the bond and as the inner layer of the bag. The flexible bag preferably has a multilayer laminate film of PVC, polyethylene, polyamide, and mixtures thereof or such as polyethylene / ethyl vinyl acetate and polyamide / polyethylene. The multilayer polymer tube of the joint may have an outer layer comprising, for example, polyethylene or PVC. Thereby, the multilayer polymer tube and the flexible bag are welded to each other. The present invention will now be described in further detail with reference to the drawings, but the invention is in no way limited by this description. FIG. 1 is a vertical cross-sectional view passing through a bonding portion, a hard portion, and an adhesive portion of the bag. FIG. 2 is a cross-sectional view passing through the bonding portion of FIG. FIG. 3 is an illustration of a completed bag manufactured according to the present invention. As shown in FIG. 1, a preferred embodiment of a dispenser unit according to the invention is a sealable polyolefin, such as polypropylene or polyethylene, a polypropylene compound or the like, which forms a tight seam even at sterilization temperatures. Is a multi-layer film bag having as an inner layer. The joints, here embodied as two layers of polymer tubing, have as their outer layer a polyolefin weldable to the inner layer material 30 of the bag, such as polypropylene or polyethylene, a polypropylene compound, or the like. And welded to the inner layer 30 of the bag foil. The bonding portion has, as the inner layer 11, a polyethylene copolymer high in ethyl vinyl acetate. The polyethylene copolymer is capable of being welded to the polycarbonate part 20 after radiation crosslinking, forming a liquid-proof weld seam that resists sterilization and maintaining its flexibility and elasticity even after sterilization. Are now welded into the already radiated joint. Example 1 A two-layer tube of 8 mm diameter having an outer layer of 0.45 mm thick polyethylene containing CARATON and an inner layer of 0.5 mm thick polyethylene high in ethyl vinyl acetate was used as a joint in a known manner. Extruded co. The tubing is then cross-linked by radiation, leading to an inner layer material that is resistant to temperatures above about 160 degrees. An extruded two-layer bag having an outer layer of polypropylene and an inner layer of a thermoplastic elastomer similar to the outer layer of the bond is then bonded to the cross-linked tubing by high frequency welding. The tube mounting part of the rigid polycarbonate part is then inserted in a known manner inside the joint and welded. Crosslinked polyethylene high in ethyl vinyl acetate thus forms a durable, tightly sealed seam under the temperature conditions of steam sterilization. Experimental Example 2 A 6 mm outer diameter two-layer tube having a polyethylene outer layer of about 0.5 mm thick and a polyethylene inner layer of about 0.5 mm thick containing ethylvinyl acetate was co-extruded by a known method. You. The tubing is then radiation cross-linked, such that the inner layer is an inner layer material that is resistant to temperatures above about 160 ° C. A co-extruded two-layer bag having an outer layer of polyethylene and an inner layer of a polyethylene compound including an elastomer is formed into a crosslinked tubing having a polyethylene compound on the outer surface and a crosslinked polypropylene high in ethyl vinyl acetate on the inner surface. , And then joined by high frequency welding. The polycarbonate part is then inserted and sealed by known methods. Example 3 Two-layer tube with an outer diameter of about 8 mm and an inner diameter of about 6 mm, having an outer layer of ethyl vinyl acetate polypropylene having a thickness of about 0.45 mm and a polyethylene inner layer having a thickness of 0.5 mm high in ethyl vinyl acetate. Are co-extruded in a known manner. This tubing is then radiation cross-linked, thereby leading to an inner layer material that is heat resistant to temperatures above about 160 degrees Celsius. Includes 200 μm thick outer layer of polypropylene and a thermoplastic elastomer (CAWITON, available from Wittenburg, Bissam, The Netherlands) and 200 μm thick middle layer of polypropylene and a relatively high thermoplastic elastomer (CAWITON N) A co-extruded three-layer bag, extruded into a water bath, consisting of an outer layer of polypropylene having a thickness of 250μ, is then crosslinked with an outer surface of polypropylene containing a thermoplastic elastomer (CAWITON N) and a high content of ethyl vinyl acetate. To a cross-linked tubing having a polyethylene interior surface by high frequency welding. The polycarbonate part is then inserted and sealed in a known manner. For example, dialysate for continuous ambulatory peritoneal dialysis or CPAD can be contained in the bag, steam sterilized, and stored in the bag. Although the present invention has been described with reference to preferred exemplary embodiments, it is not intended to be limited by these or the specific illustrative examples shown. Any further embodiments to be protected by the claims will occur within the ability of those skilled in the art.

[Procedure for Amendment] Article 184-8, Paragraph 1 of the Patent Act [Date of Submission] July 31, 1998 (1998.7.31) [Contents of Amendment] Claims 1. A flexible polymer bag, a joint (10, 11) and an inflexible rigid part (20), wherein the joint is an inner layer (11) welded to the rigid part, and A polymer outer layer (10) welded to the inner material, wherein the inner material (30) of the flexible bag and the outer material (10) of the joint are the same material and are heat sterilizable The flexible bag is bonded with a foil of polyethylene, polypropylene, polyamide and their compounds including thermoplastic elastomers, especially as SEBS compounds or their PE / EVA, PA / PE, PP / SEBS etc. A dispenser unit comprising: a multi-layer composite foil (30, 31); and at least one of PVC. 2. The rigid part (20) is a polymer such as polycarbonate or polyethylene, and the inner material of the joint is weldable to the rigid part by creating a sterilizable weld seam. The dispenser unit as described. 3. The said joint has an inner layer such as crosslinked polyethylene or PVC high in EVA and forms a heat sterilizable bond with the rigid part such as polycarbonate or polyethylene. A dispenser unit according to at least one of the preceding claims. 4. The bag material has an outer layer of polypropylene and an inner layer of a polypropylene compound, and the bonding portion has an outer layer of a polypropylene compound welded to a hard portion of polycarbonate, and an inner layer of radiation-crosslinked polyethylene or PVC high in EVA. A dispenser unit according to at least one of the preceding claims, comprising: 5. Co-extruding the multi-layer bag material, co-extruding the multi-layer joint, sealing the decoction bag material, sealing the inside of the multi-layer joint, and sealing the inside of the hard part. A method for manufacturing a dispenser unit according to at least one of the preceding claims. 6. 7. The method of claim 6, wherein the co-extruded joint has an EVA-rich polyethylene as its inner layer and is independently radiation cross-linked before being sealed. 7. Use of a dispenser unit according to at least one of the preceding claims, which is a dispenser for liquids, in particular water-containing liquids for medical or veterinary or nutritional purposes. [Procedure for Amendment] Article 184-8, Paragraph 1 of the Patent Act [Date of Submission] November 11, 1998 (1998.11.11) [Details of Amendment] Claims 1. A flexible polymer bag, a joint (10, 11) and an inflexible rigid part (20), wherein the joint is an inner layer (11) welded to the rigid part, and A polymer outer layer (10) welded to the inner material, wherein the inner material (30) of the flexible bag and the outer material (10) of the joint are the same material and are heat sterilizable Wherein said flexible bag is a foil comprising at least one of PVC, polyethylene, polypropylene, polyamide and a compound thereof with a thermoplastic elastomer , especially a foil comprising their SEBS compound, or PE / EVA; PA / PE, dispenser unit, characterized in that with their multi-layered multi focus foil (30, 31), such as PP / SEBS. 2. The rigid part (20) is a polymer such as polycarbonate or polyethylene, and the inner material of the joint is weldable to the rigid part by creating a sterilizable weld seam. The dispenser unit as described. 3. The said joint has an inner layer such as crosslinked polyethylene or PVC high in EVA and forms a heat sterilizable bond with the rigid part such as polycarbonate or polyethylene. A dispenser unit according to at least one of the preceding claims. 4. The bag material has an outer layer of polypropylene and an inner layer of a polypropylene compound, and the bonding portion has an outer layer of a polypropylene compound welded to a hard portion of polycarbonate, and an inner layer of radiation-crosslinked polyethylene or PVC high in EVA. A dispenser unit according to at least one of the preceding claims, comprising: 5. Co-extruding the multilayer bag material, co-extruding the multilayer joint, sealing the bag material, sealing the inside of the multilayer joint, and sealing the inside of the rigid portion, A method for manufacturing a dispenser unit according to at least one of the claims. 6. 7. The method of claim 6, wherein the co-extruded joint has an EVA-rich polyethylene as its inner layer and is independently radiation cross-linked before being sealed. 7. Use of a dispenser unit according to at least one of the preceding claims, which is a dispenser for liquids, in particular water-containing liquids for medical or veterinary or nutritional purposes.

────────────────────────────────────────────────── ─── Continuation of front page    (81) Designated countries EP (AT, BE, CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, L U, MC, NL, PT, SE), OA (BF, BJ, CF) , CG, CI, CM, GA, GN, ML, MR, NE, SN, TD, TG), AP (GH, KE, LS, MW, S D, SZ, UG), EA (AM, AZ, BY, KG, KZ , MD, RU, TJ, TM), AL, AM, AT, AU , AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, G B, GE, HU, IL, IS, JP, KE, KG, KP , KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, N Z, PL, PT, RO, RU, SD, SE, SG, SI , SK, TJ, TM, TR, TT, UA, UG, US, UZ, VN

Claims (1)

[Claims]   1. Flexible polymer bag, joints (10, 11) and inflexible rigid part (20) Has,   The coupling part is formed by an inner layer (11) welded to the hard part and the flexible bag. An outer polymer layer (10) welded to the inner material;   The inner material (30) of the flexible bag and the outer material (10) of the joint are the same material And dispensed in a heat-sterilizable manner knit.   2. The rigid portion (20) is made of a material such as polycarbonate or polyethylene. A rim, and the inner material of the joint is made by creating a sterilizable weld seam. The dispenser unit according to claim 1, wherein the dispenser unit is weldable to the dispenser. To   3. Polyethylene, polypropylene, polyamide and thermoplastic elastomer Foils of those compounds comprising, in particular as SEBS compounds or Multi-layer composite films (PE / EVA, PA / PE, PP / SEBS, etc.) 30, 31), and at least one of PVC is included in the flexible bag. A dispenser unit according to at least one of the preceding claims.   4. The connection is made of an inner layer such as EVA-rich cross-linked polyethylene or PVC. Has heat sterilizable with the hard part such as polycarbonate or polyethylene Forming a secure bond. Dispenser unit.   5. The material of the bag is an outer layer of polypropylene and an inner layer of a polypropylene compound. Has,   The bonding part is a polypropylene compound welded to a hard part of polycarbonate. Outer layer, and inner layer of radiation-crosslinked polyethylene or PVC high in EVA A dispenser according to at least one of the preceding claims, comprising: Sir unit.   6. Co-extrusion of the multilayer bag material, co-extrusion of the multilayer joint, Seal the material, seal inside the multilayer joint, seal inside the hard part A dispenser as claimed in at least one of the preceding claims. Knit manufacturing method.   7. The co-extruded joint is made of EVA-rich polyethylene as its inner layer 7. The method according to claim 6, wherein the radiation crosslinking is performed independently before being sealed. Production method.   8. Liquids, especially water-containing liquids for medical or veterinary or nutritional purposes. A dispenser unit according to at least one of the preceding claims, which is a dispenser. How to use the kit.