SI8410280A8 - Bag for storaging liquides - Google Patents

Description

FIELD OF THE INVENTION

The invention is in the field of packaging, in particular the packaging of cd plastic fluid storage. The MPK mark is A 61M 5/14.

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Defined technical problem

It is necessary to create a liquid storage bag that will be lightweight, inexpensive, so that after use, it will be thrown away, which will be flexible, foldable and carefully treated so that any changes to the fluid stored therein can be immediately compared. The state of the art

The invention relates to a fluid storage bag, especially for use in medicine for the storage of fluid or infusion solutions, made of thermoplastic polymeric material and with at least one emptying sleeve in which there is a tube.

Keaice of this kind are used in medicine in millions of quantities. They are used to receive blood, such as blood bags, or to store sterile medicines that are not given orally and for infusion solutions to be given to patients. For this purpose, they must be completely sterile, which is usually achieved by heating O o to at least 100 C, and in particular to about 120 C. It also results in a condition imposed by thermoplastic polymeric materials, namely that they remain stable at least up to the heating temperature.

Because of this, this kind of bag has to be lightweight, cheap, and has to be manufactured by an automatic manufacturing process, and because of the low cost, it cuts out after use to throw it away. Furthermore, it should be flexible, agreeable and so transparent in the processed state that changes in the fluid stored in the bag can be immediately noticed.

The only polymer that met these prerequisites so far was the use of soft polyvinyl chloride (soft PVC), which 3β, to improve its elastic properties, contained softeners. These softening materials, such as diisooctiftalate, cause adverse and dangerous occurrences. Thus, these materials are not completely enclosed in the cavities between the polymer chains, so they can dissolve with the water filled with the bag, or aqueous solution, and be separated from the polymer so that the fluid contained in the bag is contaminated.

Estimates. have indicated that over a long period of use of such polyvinyl chloride bags, the patient may introduce several grams of emollient into the body, which is physiologically very dangerous and may cause permanent damage to the patient.

A soft PVC bag can be easily attacked by micro-organisms, which especially soften the softener and thus, as a rule, destroy the bags. Therefore, such polyvinyl chloride bags after filling must be protected by a special sheath against harmful microorganisms .;

This situation has led to the fact that polyvinyl chloride bags have failed to significantly squeeze glass bottles as liquids such as medical solutions, p3, in some industrial countries, from their use in the medical field.

Therefore, tests were performed to replace soft PVC with other materials. These tests have shown that these materials are either too expensive or have mechanical and physiological defects. Thus, for example, all have too high a permeability for water vapor, which leads to an unwanted increase in the concentration of the material in solution. As a result, loose components are released, or easily damaged by heavy mechanical loads.

The Swiss patent describes one plastic bag that can be used to hold therapeutic fluids that are not given through the stomach. With this plastic bag, the wall consists of a plastic laminate, which has a layer of polyvinyl chloride on the outside, which is not in contact with the liquid, and a polyhalogen-hydrocarbon resin layer on the inner side. The last layer has no pharmacologically permissible ingredients which, due to the dissolution, can pass into the solution held in the bag. roller hal oger.sks and hydrocarbons used in this bag have the disadvantage that their production is very expensive as well as cool down, and the seams at the seams are not sufficiently melted by heat insulation, so there is still a touch with polyvinyl chloride. This touch usually exists at the outlet, which is usually made entirely of PVC, and which can be connected to another PVC connecting hose. In addition, such a discarded Resica is a source of environmental pollution, because the combustion of such a Resica develops a very aggressive halogen-hydrogen compound.

Another bag is described in U.S. Pat. 41 40 162. This bag consists of a plastic compound with three components. These components are one polyolefin, essentially consisting of a polypropylene unit, one block copolymer and, possibly, a plasticizer, which may also be a polymer. In addition, this bag can have antioxidants, which are certainly not harmless from a hygienic point of view.

The previous description of the components shows that the components themselves, as well as their processing, are expensive, and the bags made in this way cannot replace the usual PVC bags, both because of the difficulty of production and the stepping price.

Therefore, the applicant has filed a new plastic compound for the production of connecting elements between PVC casings and polyolefin bags (German patent application DE-03 30 26 974). This plastic compound consists of several polymer components for the product of which . and the price is all that is said above. Among other things, this bonding element has to be welded to both the polyolefin bag and the PVC gut, which certainly creates difficulties to accomplish such a process and therefore entails great costs.

Care should be taken to ensure that all previous solutions use PVC-t bonding hoses, which at the same time contain softening agents and are therefore considered dangerous.

These connecting or connecting casings are welded to the PVC sacks in the form of discharge sleeves, and they have the desired properties of high elasticity that are necessary for holding various attachments. The fluid accumulating in the bag when sterilized by heating at about 120 ° C must not leak between the outlet of the sleeve and the attachment.

Therefore, it must tighten the gut so that it can only be separated by very high strain.

The German patent application attempted to address these problems by making a polyolefin bag with a single gut insert, or a special mesh copolymer insert consisting of olefins and vinyl acetate. For example, a bag with a hose or insert made of a copolymer that is not yet mesh is welded, after which the entire bag is subjected to processing to form a polymer network.

It should be noted that in the grocery industry for a long time, food packaged in plastic bags has been encountered, in which the bag has a welded discharge tube made from the same material as the bag. This discharge hole has no known high elasticity properties, and can sterilize only if the sam3 bag can be sterilized.

Description of a solution to a technical problem with examples of execution and a list and brief description of plan pictures ~, ______

On the basis of all of the foregoing, it is an object of the present invention to provide a single bag of the type described, which will have at least one syringe tube of material to be provided. different from the material of the bag, and which is stable at temperatures of at least 1 ° C and can be sterilized by heating.

According to the invention, this is solved by the properties specified in the characteristic part of claim 1.

According to the invention, a bag can be manufactured that can be made from plastics, such as polyethylene, which are very

- 5 suitable for their price. For the production of foil or gut foil, standard 'lis print iv ati' methods can be used, which does not present a serious problem for the expert.

And tubes, or inserts, which are generally rigid and best completely rigid, are made at the cost of very suitable plastics and by a simple standard procedure.

The use of polycarbobates and other hard plastic materials for the manufacture of casings, pillows, plugs and other relatively rigid objects is known in medicine. It is also known that tubes of such materials cannot be attached to Ke3ice for storing liquids made of polyolefin, since polyolefin cannot be welded to hard plastic materials and therefore a seal between the bag and the tube cannot be maintained.

According to the invention it is found that tubes and inserts of hard plastic can be attached to polyolefin bags using a single bond layer.

This bonding layer, which is placed between the tube or the insert and the bag, is made of the cost of very suitable olefin-based materials, which are copolymerized with one specific vinyl acetate (VAC) content. As is known, by this. Olefin and vinyl acetate copolymers with increasing vinyl acetate content have an abrupt increase in rebound elasticity, which is one measure of material elasticity. Thus, for example, for ethylene-vinyl acetate copolymers with increasing vinyl acetate content, the bounce elasticity increases, but, on the other hand, the melting temperature decreases in the interest region of the vinyl acetate content so that it falls below 1OC ° * C, so that sterilization of the bag with such a bonding layer it is no longer possible.

Polyolefin-based casings containing vinyl acetate can be thermally stabilized by forming a polymer network, thereby improving their elastic properties, but this is no longer possible

V * Weld the intestines directly with the starting clefin, which serves as the bag material. A bond can be formed between the polyolefin and the mesh copolymer of olefin and vinyl acetate. Therefore, according to German patent DE-PA 3 200 264, it is suggested that 3e bags of polyolefin and netting of olefin copolymer, in particular ethylene, and vinyl acetate, be welded to one another and then subjected to mesh processing.

According to the invention, it is found that the bonding layer of one copolymer of olefins, especially ethylene, and vinyl acetate, or polyurethane, can also melt with a polyolefin bag and with a hard plastic mass, in particular polycarbonate, which is a tube or insert, and that under pressure can be sterilized without prior formation of a polymeric mesh. As the sterilization of the copolymer of olefin and vinyl acetate, or polyurethane, becomes very soft, a bag which is completely hermetically sealed and possesses extraordinary mechanical properties and excellent holding properties on the tube alone, so that the attached attachments or hubs are no longer attached can separate. The tube or insert is tightly, completely hermetically sealed and connected to the polyolefin bag via a bonding layer. A tube or insert can no longer be separated from the bag without destroying it. Such sterilizers, 'which can be sterilized in their properties, at least in terms of their mechanical properties, are at least equal to the properties of the known P7C bags.

_ ._ As a polyolefin material, which is used as a bag material, and which is used in the form of foils, does not contain any softening material. practically eliminated the risk of attack by microorganisms. Therefore, the bag according to the invention can in any respect be considered as a hygienic self in comparison to the multiple PVC bags used today.

Kade polyolefins, which are used as polymers for the production of bags according to the invention include olefin polymers such as ethylene, propylene, butylene and the like. Ethylene is particularly suitable as the starting olefin, which can be optionally substituted by one or more groups.

This substitution can be carried out, for example, by methyl or ethyl group, vinyl group and halogen atom, especially fluorine atoms.

- 7 e til en ..

Particularly suitable examples of polyolefins are polyethylene, pclipropylene, poly-n-butylene, polyisobutylene, poly-4-methylpentene-1, chlorosulfouiraGi polyethylene, polystyrene, halogenated polyethylenylidene, polystyrene, halogenated polyethylenylidinylidene , polymethylmethacrylate and the like. The olefins for the production of said polyolefins may be replaced as copolymers and mesanipolymers by other vinyl bonds or compounds, such as ethylene / propyl plastic, poly (ethylene / vinyl acetate), arylitrile / hutadi yen / styrene polymer, ethylene propylene -block copolymer, styrene copolymer, vinylenfluoride in various copolymers, as well as styrene-containing copolymers.

Polyolefins are a product of the present invention, which are produced by vinylpolymerization of optionally substituted ethylene. These products may have small additives from other polymers, which do not essentially interfere with or alter the structure of these polyolefins. Thus, for example, small amounts of ethylene compounds substituted with styrene or polyacrylonitrile can be added. The polyolefin products thus obtained can be considered to belong to the above mentioned polyolefins.

According to the invention it is advantageous to use the bags as a polyolefin polyethylene material, which may have small admixtures of vinyl, acetate in the form of copolymers of ethylene and vinyl acetate. In one such case, for example, the vinyl acetate content may be up to 10 Jfc by weight.

In particular, medium or high density polyethylene, which is normally obtained by low-pressure polymerisation, will be used. In this case the density ranges from 0.91 to C, '§4, and in particular about 0.935 g / cm \

The polyethylene best used in the present invention has a high molecular weight and a narrow molecular weight distribution.

In any case, care should be taken to ensure that the melting point below the sterilization temperature is from 110 to 120 ° C. The melting range is preferably above 116 ° C and preferably between 120 and 124 ° C, with the vinyl acetate softening temperature according to DIN 53460 above 115 ° C.

The permeability of the mesa oxygen in said polyolefins to be a problem for the r astvor. which are stored for a longer period of time, as the dissolved components may oxidize. This is especially critical for amino acid solutions and must be eliminated.

To solve this problem, the bag of foil of the aforementioned polyolefin may be coated on the outside with a single layer, or with multiple layers that reduce the permeability of oxygen, for example a metal foil or other polymer. Such wrapping will also be introduced for safety reasons, because even with the most careful production of the bag for the bag, small openings (needle punctures) occur in the bag, which can adversely affect the sterility of the bag solution.

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Such sheathing can also greatly improve the mechanical resistance of the bag, so _: such a bag even when used. throw from a height of several meters will not burst.

It is also advantageous that such a film or layer has a higher melting point than a polymer that is in contact with the solution, so that at the melting temperature of the inner film it does not melt, so that it does not cling to the welding tool.

In addition, such an outer film serves as a separating agent for welding with the heat of the inner film.

Any of the polyolefins previously shown may be used as a polymer for making such laminates. Most suitable are those polymers which have low water vapor permeability and low oxygen permeability. This group includes polyamide, polyvinyl chloride, polyvinylidene chloride, polyvinylfluoride, polytrifluorochloroethylene, polyethylene terephthalate, polyester and the like. Particularly suitable are polyamide, polyvinylidene chloride, polyethylene terephthalate and polyester.

As polyamide, it is advantageous to use one polycaprolactam, which can be treated and sterilized with a superheated steam temperature of 120 to 140 ° C without damage. This polyamide contains no stabilizing additives and is generally suitable for use in the food industry.

The outer and inner film polymers will be bonded with a suitable adhesive, such as polyvinylidene chloride or some polyurethane. Such a polyurethane adhesive may be two-component, the first being a foil adhesive, while the second component consists of an additional adhesive.

As for the manufacturing technique, the polyolefin used as the inner foil can be produced by extruding in the form of a gut film and then using the aforementioned adhesive, the poly urethane being very suitable, adhering to the laminating film. If PVC is used as the outer film, the polyethylene film according to the invention provides that the 'softener .. which is present in PVC cannot diffuse through the adhesive and polyolefin film into the solution contained in the bag.

Suitable laminates have a temperature of about 23 ° C and relative humidity. from $ 85, as a rule, permeability for water vapor according to DIN 57122 which is less than 1. This value is valid for standard laminates having a thickness up to 0.2 mm, with a thickness of ppliolefin from 50 to 100, most preferably 75 / Um, and 20 to 100, most preferably 30 to 70 / um for a laminating film, such as polyamide.

With such laminates, the permeability of the oxygen 2 is also reduced, with this value lying below 15 cm / m xday x bar pressure difference.

These foils have been approved by the Federal Ministry of Health in the Federal Republic of Germany, the Berlin Office, and by the Federal Drug Administration in the United States, for their physiological safety, for use in the field of food production and medicine.

As mentioned above, the liquid-filled polyolefin film contained in the bag does not contain any softeners or additives that would be physiologically hazardous and, above all, could diffuse in aqueous solution. In addition, the polyolefin film, which is coated with an organic laminating film, is clear and transparent and retains these properties after sterilization.

As a material for tubes or inserts, which are used according to the invention, and which are to be rigid and transparent, java is used hard plastics, ie hard polymers, ie. plastics, which, at pressures of at least 1 bar, can be deflected at a specified nominal value, and which 3U with. the point of view of medicine is harmless; have no adverse effect on the patient. Hard plastic PVC, polypropylene, polyamide, polycarbonates, polyester, polyacrylate and the like are used from these hard plastic materials. and / or copolymers the same as those containing styrene, especially polycarbonates.

Suitable polycarbonates, for example, are those composed of 4,4'-dioxy-diphenyl-alkane, for example, 4,4'-dioxydiphenyl-methane, 4,4-dioxy-diphenyl-1,1-ethane, 4 , 4'-dioxy-diphenyl-1,1-butane, 4,4'-dioxy-diphenyl-1,1-isobutane, 4,4'-dioxifenyl-1,1-cyclopentane, 4,4'-dioxy- diphenyl-1,1-cyclohexane-N,, 4 '-dioxy-diphenyl-f-enyl-methane, 4, 4'-dioxy-diphenyl-2,2-propane, 4, 4' -dioxy-diphenyl- 2-, 2-butar, 4,4 ' -dioxy-diphenyl-2,2-pen tare,

4,4 '-dioxy-diphenyl-methyl-isobutyl-methane, 4,4' -dioxy-diphenyl2,2-hexane ^ 4,4 '-dioxy-diphenyl-2,2-nonane ^ 4,4'-dioxy -diphenylmethyl-phenyl-methane-4,4'-dioxy-diphenyl-4,4-heptane or 4,4'-dioxy-diphenyl-1,2-ethane. One suitable polycarbonate, for example, is the polycarbonate debut of 4,4'-dioxy-diphenyl-2,2-propane (bisphenol A) and carbonic acid.

Suitable polyesters include saturated linear polyesters as well as unsaturated and aromatic polyesters, such as polyethylene glycol terephthalate, polybutylene terephthalate or polyether.

The use of jive polyamide includes those for which; kai>; po11

Even materials use straight chain carbon-carbon acids, chain lengths C ^ -C ^^, * ⁿ ih lactams, adipic acids, sebacic. acids, dodecandiic carboxylic acids and heptadecacdiacarboxylic acids hexamethylenediamine, isophthalic acids, bis (4-aminocyclohexyl) -methane, 2,2-bis- (4'-aminocirtlohexyl) -propane, 3 f 3 ^z -dimethyl-4, 4 '-diaminodi cyclo -methane, terephthalic acids or their dimethyl ester, 1,6-diam: no-2,2,4-trimethylhexane,

1,6-diamino-2,4,4-trimethylhexane, 1-amino-3-aminomethyl-3,5,5-trimethyl-cyclohexane, polyethylene, mixed polymers of ethylene, propylene, butylene, vinyl ester and unsaturated aliphatic acids as well as their salts and esters.

Post-polyacryates include, according to the invention, polyacrylic acid esters obtained either from acrylic acid or from methacrylic acid, such as, for example, polymethylmethacrylate.

A copolymer of one olefin with vinyl acetate or some polyurethane will be used as the binder material. Examples of the polyolefins obtained * from these olefins are polyethylene, polypropylene, poly-n-butylene, polyisobutylene, halogenated polyethylene, chlorosulfocated polyethylene, etc., as discussed above. It is convenient to use polyethylene. Gvi copolymers have a vinyl acetate content of 5 to 70, preferably 10 to 50, and preferably $ 15 to $ 40, by weight. The vinyl acetate content, for example, can be 2δ $ by weight. As stated earlier with increasing vinyl acetate content, the melting point of polyethylene drops from about 125 ° C to about 70 ° C, when the vinyl acetate content of 3θ% by weight is reached. Such a copolymer will naturally melt completely at a sterilization temperature above 1 ° C. On the other hand, the rebound elasticity, more precisely the hardness measured by the rebound method, increases these copolymers from $ 35 to $ 55 at $ 30 of vinyl acetate content.

These materials can be easily used with the bag material, if they are similar or the same polyolefin materials, and can also be welded with the tube or insert material. It is therefore advantageous to use the same polyolefin materials for the bonding layer and for the bags. It is advantageous to use a copolymer of ethylene and vinyl acetate with the aforementioned density band as the bonding layer, preferably using polymerized ethylene and propylene compounds as the bag material. Particularly suitable is a combination of ethylene-vinyl acetate as a binder material and polyethylene as a bag material in the above-mentioned density range.

Suitable polyurethanes include, for example, those for the production of carbonic acid, adipic acid, phthalic acid, tricellic acid, sebacic acid, sebacic acid, maleic acid, or ethanediol, vinyl chloride and vinyl acetate mixed polyester poliol. or • vinylpropionate, in which free hydroxyl groups can be retained, epoxy compounds made from (4,4 ^z- dioxy-2,2-diphenyl) propane and epichlorohydrin, as well as vinylidene chloride copolymers.

The thickness of the bonding layer is not critical. It should be at least 0.1 mm and should not exceed 7 mm for practical reasons. Suitably, the bonding layer has a thickness of 0.1 to 4 ce.

The tube is referred to as the insert. the invention, a tubular body, or a larger insert that contains one or more tubular bodies, - or has multiple tubular openings, which provide a connection for the passage of fluid between the interior of the bag. with hoses, infusion accessories, catheters, syringes, etc., to which the outer end of said insert is connected. This also includes one insert that is welded into the bag through the bonding layer and contains at least one i3pass opening without passing through the edges of the bag in the form of tubes or casings. Such an insert will, like one of the tubes, be wrapped in a single bond layer, then inserted into the border or edge area of the bag that has not yet been welded, and will finally be thermally welded to the bag.

As stated above, tubes and / or inserts can be attached directly to the edge of the bag without any of the tubular portions extending beyond the edge of the bag. This embodiment is intended for inserting elastic plugs or sleeves into tubular openings.

According to another embodiment, the tubes and / or parts of the inserts can be provided in the form of tubes extending over the edge of'Resica, and can be pulled on the hose or the hose of a highly elastic, physiologically dangerous material such as gum3, mesh ethylene vinyl acetate and the like. The tubes and or tubular parts of the inserts themselves may be funnel-shaped or thickened and funnel-shaped extensions may extend beyond the edge of the ke3, whereby these extensions may save one memory material used for that purpose and one cover made of resilient material or a puncture insert, for example latex, which can be cured as an infusion stopper or for injection.

The fabrication and preservation of the bag material is performed by 3e according to the usual plastic techniques. For example, it is easy, for example, to say that the bags are made of foil in the form of a gut made by extrusion, with a fork, of a suitable section of foil and then welded along the edges. This bag, in which the edge of the outlet pipe predictor remains unsecured, is supplemented by a single tube or insert having a discharge outlet or openings. which are coated with a bonding layer and then welded. The bonding layer is attached to the tube, the attachment layer by a conventional technique, for example by simply pulling it in or collapsing elastic material in the form of a bowel onto the tube or insert, and then inserting it into the bag. Subsequently, heat welding of the still-welded edge by the tube or insert wrapped in the bonding layer is performed. If more than one tube is provided, these machining operations are performed simultaneously, using the appropriate tools. for heat welded. Welded with heat, which is carried out in the usual way, it will be a bag welded with a binder layer, and this one with a tube or insert.

The bag made in this way has essentially the same properties as the PVC bag, with the exception of the ethylene-vinyl acetate bonding layer, when sterilized at temperatures above about 80 ° C, softens sharply, but with tubing and foil keeps the heat resistant in place. The weld seam, which is made between the bag, the bonding layer and the tube or insert, is so tight that only the forced separation of these elements is possible

- 14 The sterilization of the bag made in this way is done by the usual procedures in autoclaves whereby, in order to avoid splashing of the bags, the autoclaves must be pressurized to equalize the internal pressure in the tubes. For safety reasons, and to secure that veil layer, a higher care overpressure is used, which is required to equalize the pressure exerted inside the bag. The magnitude of this pressure above the pressure exerted in the bags is not critical, and may, for example, be at least about 5 bar above the pressure exerted in the bag. It can be 2 to 3 bars, for example 2.2 bars.

The bag thus constructed, which has a single tube and a bonding layer, and is closed by welding with heat, is filled with water or a suitable sterilizing solution (eg electrolyte solution) and then pressed into an autoclave with a pressure in which it is sterilized at a temperature of about 120 °. C and at a pressure of about 2.2 bar.

As mentioned above, this treatment uses an olefin and vinyl acetate co-climmer, which is used as a bonding layer, to melt, "

the bag is completely sealed and does not leak, and its mass remains constant, ie. there is neither loss nor gain of mass.

The bag according to the invention will be through the attached drawings and illustrated examples in more detail, whereby:

- .figure 1 shows the infusion bag according to the invention as intended for infusion schematically in a horizontal projection,

- Figure 2 shows a cross-section along line II-II of Figure 1,

- Figure 3 shows the edges of another embodiment of the bag with closures for injection and infusion,

- Figure 4 shows a cross-section of the edge of the bag according to the invention with an ethylene-vinyl acetate cap,

- Figure 5 shows one detail of a horizontal projection of a single insert with tubes extending over the edge of the bag, but without a tear-off cover,

- Figure 6 shows a section along the line V-V in Figure 5,

- Figure 7 shows a second embodiment in horizontal j projection similar to that of Figure 5,

- Fig. 8 is a cross-sectional detail of one embodiment, showing the engagement of the tube with one head,

- Figure 9 is a detail of another cross section of another embodiment showing a welded latex bead with an ethylene-vicacetate binder layer with a sheath.

The bag 10 consists of a chamber 12 closed on all sides by a welded edge 14, wherein the bag 10 has two discharge openings 16 and 18, which are connected to one tube 20 and 22 each, which serve as the discharge Saure. Through these tubes 20 and 22 can the fluid being stored, such as infusion solution or blood, to be introduced into the bag 10, wherein one or both tubes can be used as filling ports.

The bag 10 is usually made so that the foils needed to make the bags are stacked one over the other, to eventually extract the welded edge 14, the outlet openings 16 and 18 being skipped. The tubes 20 and 22, to which the bonding layer is applied, are then placed in the discharge openings 16 and 18, after which the foil bags are welded along their outer surface. As stated above, it is advantageous to use polyethylene as a bag material, and a binder layer 19 of ethylene and polymer. vinyl acetate, and that _; welds for polycarbonate which. used for 20/22 tubes, which results in sterilization of the bags at about 120 ° 0 and about 2 bar of pressure in autoclaves under pressure.

When administered for infusions, the tube 20 of Fig. 3 is made in the form of a funnel, wherein the enlarged end end is closed by a sterile, 24-pierced, puncture-shaped membrane, which is made in a conventional manner. of used hhlhtobutir. rubber. Membrane 24 is connected by a common technique to a tube made of polyarchones and covered with a lid from hygienic racks 25 ·

For injection (injected) of the solution or the like, according to Figure 3, a second funnel tube 22 may be fitted, to which a puncture insert 27 will be mounted, the yen mode.

- 16 for example, latex. Both tube 20 and tube 22, wrapped with an $ 1 bond.

As the bag 10 is dislodged so that the tubes 20, 22 are facing downwards, whereby the solution from the bag can easily flow out, it may be possible to draw on the edge opposite to the one on which tubes 20,22 the opening of the bag 10 is arranged. hook holder of a tripod or the like.

According to the embodiment shown in large scale in Figure 2, the laminate bag material 30 is made of multiple foils. Laminate 30, as recommended. on the side of the solution polyethylene film 32, which is 30 to 100 thick, preferably 75 / Um. This polyethylene was found to have a density of 0.935 g / cm &lt; 2 &gt; m of melting point from 121 to 124 [deg.] C. and a softening temperature of vinyl acetate of about 18 [deg.] C.

The polyethylene foil 32 is glued with a polyurethane adhesive to the polyamide foil 34, which typically has a thickness of about 30 to 70 / um.

Figure 2 shows that the polyethylene foil 32 in the transition region u to the tubes 20 and ~ 22 has a bonding layer 19, which creates an internal connection between ~ foil and tubes 20, 22, so that the withdrawal of tubes 20, 22 from the bag 10 is only possible at the cost of destroying the whole bag.

Figure 4 shows a detail of the edge portion of one embodiment of the bag according to the invention, in which the tubes 20 and 22 are mounted on tops 38.

Toward the ends of the tubes 20, 22, there is a nozzle 38, which is adjacent to the inlet opening 40 covered by a membrane 42 extending transversely through the inlet opening 40, which seals the interior of the bag tightly with respect to the outside environment. The membrane 42 will penetrate the top of the infusion device, which is not shown, so that the fluid contained in the bag 10 may flow through it.

As the bag 10, as already mentioned, is suspended downwards, therefore, as the fluid contained in the bag can flow through the tubes 20, 22 facing down, there is no effective sealing provided

-1 between the top of the infusion device and the wall of the head. Therefore, a ring reinforcement 44 was formed on the wall of the head in the region of the inlet opening 40, which tightly and sealed the said tip when it penetrated the membrane 42.

When welding a tube with a tie layer, the tube and the latex ball are one spindle. No other internal dosing aids are needed.

In order to keep the self3 membrane sterile after autoclaving, the inlet 40 is covered by a closure tape 46, which can be removed when the bag is used.

The embodiment shown in FIG. 4 may have a special inlet port 48 at the edge of the bag 10, as shown in FIG. 1, which, like the discharge openings 16 and 18, is skipped during welding when making the bag. The opening 48 allows the bag to be filled and welded or melted as usual after filling.

Another embodiment is shown in Figures 5 and 6.

An insert 50 which has, as shown in Fig. 5, a lenticular cross-section *, is enclosed therein, and is coated with a bonding layer 5 3. Such. shape facilitates _; and at the edges welding with the inner foilF32, so that a nearly continuous transition is ensured between the welding edge 14, the connecting layer 53 and the insert 52.

—Inlet 52, according to the embodiment shown in FIGS. 5 and 6, are the inlet and outlet ports 54 and 56. An i-hole 58 for filling is also provided.

Intake and outlet openings 54 and 56 are fitted with casings 60 and 62, whereby these casings or heads can be made according to the embodiment shown in Figure 4. They can be made with membranes 64 and annular reinforcements 66, which is why is a required filler hole 58, which can be securely closed with a properly fitted plug after filling. The insert 52 may, however, have one or more funnel tubes 20, 22 extending outwards, as shown in Figure 3, wherein these tubes may have membranes 24 and lids 25.

- IS or puncture inserts 27, as shown in Figure 3, respectively, which are designed as plugs for infusion or for injection.

According to the embodiment shown in FIG. 6, the heads 60 and 62 are seated, weakened, lines 68 connected to the snap. cover 70, which keeps the membrane 64 sterile at the moment of use, and is easily detached before use.

Certainly, the embodiment shown in FIGS. 5 and 6 may be without membrane 64 and reinforcement 66, as well as without a tear-off cover 70, thereby avoiding the corrosion of the filling opening 58. One or more heads of 60 or 62 shapes can also be fitted ·. the gut.

Figure 7 shows another embodiment of such an insert 72, which consists of a body 74 cross-sectional in shape of the lens, which substantially corresponds to the shape of the insert 52, but has no tubular portions extending therefrom. The thickness of these inserts 52 and 74 is so measured that it coincides with the width of the weld edge 14, so that part * of body 52 and 54 does not protrude beyond that edge. Code. : body 74 of the insert shown in Fig. 7 has no gut-shaped tips; 60 and 62 which are shown in Fig. 6, so that only the inlet and outlet 76 and 78 are made on the body 74. Plugs 77 or 7S can be inserted into the inlet or outlet, 76 or 78, shown in J-on. 7a and 7b, the method is made of an elastic material having a membrane 8l and a lid 83, or a puncture insert 85, and reinforced from the inner side, which is not shown.

On the other hand, the inlet and outlet openings 76 and 78 can be closed as in the embodiment shown in Fig. 4, which means that a membrane 80 is placed which would be placed on the lower surface of the body 74 of the insert. In such a case, a filler opening 82 is shown, which is shown in Fig. 7 in a screwdriver. The fill opening 82 can be sealed with a suitably adjusted plug. The inlets and outlets 76 and 78 may, if a membrane 80 is fitted, be covered to remain sterile with a single, easily peeled, non-depicted foil covering the surface of the insert body 74

Figure 8 shows a cross-section of another embodiment, substantially corresponding to the embodiment of Figure 1, in which a gutter 84 is mounted on a tube 20, 22 which is attached to the bag 10 in the region of the edge 14.

The detail of the embodiment shown in Figure 8 corresponds essentially to the detail of the bag shown in Figure 1, with the difference that in the area of tubes 20, 22, the connecting layer 19 and the head 84 have an area 86 in which the films forming the bag are overlapped. by welding their edges 88, 90 and 92, they completely and seal the tubes 20, 22, the connecting layer 19 and the gut nozzle 84. In this way, the tubes 20, 22 with the connecting layer 19 and the gut nozzle 84 are again closed by the membrane 94, and have annular reinforcement. 96, which has already been explained in the previous embodiments so that after welding they are sterile with respect to the external environment.

The edge 14 of the bag is welded only to the area 58 when making the bag, so that the area 86 which forms the two parts of the foil 03 is open. A tube 20, 22 with a connecting layer 19 and a head 84 is inserted into the open area 86, after which this tube is welded with a connecting layer and a head 84 in the area of the welded edge 14, so that the welded edge 14 is closed all over. the extent of the bag. The area 'defined by edges 88, 90 and 92 is welded along its edges 88, 90 and.92, as shown in Figure 8, leaving the inner space 1Ό0 of area 86 unprotected.

It is advantageous to provide at the crossing between the inner space 100 and the edge 92 a seated, weakened line 102 which

if it is able, at the corresponding load, of the edge 92, which is designed as a gripping element, to break so that the edge 92 can be completely removed.

Of course, several tubes 20, 22 and nozzles 84 can be folded into one area 86, but also multiple areas 86 can be made with one tube 20, 22 each with nozzle 84. Thus. the embodiment shown in Fig. 1 may have two regions 86, separated by two tubes with upside-down points, and (one filling opening 48 not covered by either of these regions.

On the other hand, all three openings can be fully enclosed in one such area, whereby the welding method does not depend on the hinges being closed by a diaphragm or hollow plugs.

As tubular material 20, 22 and for inserts 50, 72, hard PVC, polypropyl, polyamide, polycarbonates, polyester, polyacrylates, especially polycarbonates are used, while a copolymer of ethylene and vinyl acetate with a vinyl acetate content of 5 to 5 is used as the binder material. 50% by weight, most preferably 15' to 40% by weight, and as cushioning materials 36, 60 and 62 and 84, as well as these plugs 77 and 79, a copolymer of ethylene and vinyl acetate with a vinyl acetate content of 25 to 35% by weight is selected.

Figure 9 is a cross-sectional view of another embodiment of a fluid storage bag according to the invention, in which, instead of a tube or insert, a latex ball is attached to a binding or interlayer.

The detail of the embodiment shown in Fig. 9 corresponds essentially to the bag 10 shown in Fig. 1, with the difference that, in the area of the output bushing, as shown in Fig. 8, and clear, the foils are formed by a single bag. 86 in which they fold, which after welding its edges 88, 90, and 92 completely sit tightly include a latex ball 104 and a binding or intermediate

4 ... ^. 106, The binding or intermediate 106 and the ball 104 of la: ~~ ;; tex on & on welding of this area are sterile sealed relative to the external environment.

The workmanship is the same as shown in the embodiment shown in Figure 8, except that the connecting or intermediate 106 (in the form of a single pipe section), instead of the tubes or inserts described above, is at least partially connected to its upper inner surface by a single stable-shaped insert 104. (for example, with one latex ball, as shown, or a latex cylinder), whereby this connection may be by welding or joining. Instead of latex, insert 104 may be made of another suitable and medically safe material that can be

Claims (11)

PATENT APPLICATION CLAIMS 1. Liquid storage bag, especially for medical use, for storing blood or infusion solution, made of thermoplastic polymeric material with at least one outlet tube in the form of one substantially hard plastic material. termed a tube (20, 22, 50, 72, 106) coupled to a bag (12) by means of a bonding layer (19, 53) of an olefin and vinyl acetate copier or one polyurethane. A bag according to claim 1, characterized in that the tube (20, 22, 50, 72, 106) consists of hard polyvinyl chloride, polypropylene, polyamide, polycarbonate, polyester, polyacrylate. latex, copolymers thereof, or styrene containing copolymers thereof. 3. The bag of claim 1 wherein the olefin is ethylene or propylene. A bag according to claim 1 or 3, characterized in that the copolymer has a vinyl acetate content, by weight, from 5 to 707 .. 5. The bag according to claim 4, characterized in that the copolymer has a vinyl acetate content, in weight percent, of 10 to 50%. 6. The bag according to claim 4, characterized in that the copolymer has a vinyl acetate content, in weight percent, of 15 to 40%. 7. Bag according to one of claims 1 to 6, characterized in that the material of the bag material comprises polyethylene, polypropylene, poly-n-butylene, polyisobutylene, poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated polyethylene or polymethacrylate or their copolymers or mixed polymers. ιι 8. A bag according to claim 7, wherein the polyethylene has a density of 0.9 to 0.94 and a melting range above 116 ° C. 9. Bag according to claim 7 or 8, characterized in that the film is polyethylene bonded with a single sheet of polyamide, polyethylene terephthalate or polyester. 10. Bag according to claim 9, characterized in that the laminate, consisting of polyethylene film and adhesive film, is up to 0.2 mm thick, wherein the polyethylene film has a thickness of 50 to 100 μιη and the adhesive film is a thickness of 20 to 100 μπι. Bag according to one of claims 1 to 10 *, characterized in that the bonding layer (19, 53) is applied over the tube (20, 22, 50, 72), i hundred se copolymer midfielder layer (19, 53) connects with polyolefin bags (12) i tubes (20, 22, 50, 72) connects by merging. lx. Bag towards once of the request from 1 to 11, characterized in that the binder layer is tubular in shape and is at least partially connected to the outer surface of the bag material, and as regards its inner surface, is at least partly connected to the insert of a substantially stable shape.