SI8310019A8 - Sack for storing, especially for blood or infusion solutions - Google Patents

Description

LAGING BAGS, SPECIALLY FOR STORAGE OF BLOOD OR INFUSION SOLUTIONS

FIELD OF THE INVENTION

The invention relates to bags for the storage of moles or infusion solutions and falls within the field of medical device manufacturing. According to the international pateuat classification, the invention is classified and designated by B 65 D 30/02.

Technical problem

The technical problem to be solved by the invention is the following: how to make a plastic material bag for medical purposes whose attachment will be very elastic and a retractable power coupler will only be pulled out with a large pullout, whereby the bag can be sterilized at about 110 ° C.

The state of the art

The bags of this kind were introduced into medicine in millions of quantities. They serve e.g. for the uptake of blood, such as blood bags or sterile storage of infusion solutions administered parenterally. They must be completely sterile for this purpose, which is achieved by heating them at 100 to 120 ° C. Therefore, the requirement is made for the thermoplastic material to be stable up to the heating temperature.

These types of bags need to be lightweight, cheap to manufacture and, because of their low value, can be thrown away after use. Furthermore, these bags need to be flexible, stackable and transparent in order to detect changes in the fluid contained in the bag.

The only polymer that has met these requirements so far is soft polyvinyl chloride (soft PVC), which, however, contains softeners to improve its elastic properties. These softeners are e.g. diisooctylphthalate, and can be dangerous. These substances are not completely trapped in the interstices of the polymer chains and can therefore be dissolved with water or an aqueous solution that is filled with the bag so that the fluid contained in the bag is contaminated.

Studies have shown that a patient who has been treated for a long time with such a PVC bag has several grams of emollients, which is physiologically dangerous and can cause permanent damage to patients.

The disadvantage of such bags is that they are easily attacked by the micro-organisms that dissolve the bag, and all this has caused that the use of glass bottles as storage vessels for medical solutions could not be significantly suppressed, and in many countries they were not introduced into medical bags. area.

Swiss patent file CH-PS 444 362 discloses a plastic bag which can be used for therapeutic fluids administered parenterally. In this plastic bag, the wall consists of a plastic laminate having a PVC layer on the outer side of the bag and a polyhalogen hydrocarbon plastic layer on the inside of the wall. This last layer does not contain any pharmacologically undesirable constituents that could be dissolved into the liquid contained in the bag. These polyhalogen hydrocarbon materials, however, have the disadvantage that they are very expensive to produce and process and do not fit sufficiently at the seam during welding so that direct contact with PVC is observed. and which can be connected to further PVC hoses for connection. Nedostatak ovakvih irrevocable is S _r this purpose are a waist and čovekovu Whe, Jer Prilika spaljivanja razvijaju high agresivan hlorovodik.

US-PS 41 40 162 also discloses three-component plastic bags. These components are a polyolefin consisting of propylene units, then a copolymer and optionally a plasticizer that may also be a polymer. Such a bag can also have antioxidants that are certainly not harmless on the hygiene side. The disadvantage of such bags is that their processing as well as the components of the material are expensive, and the usual bags cannot be replaced with these bags due to their rebirth and price.

From German patent application DE-OS 30 26 974, plastics are known to obtain connecting elements between PVC casings on one side and polyolefin bags on the other. This plastic is made up of multiple polymer components, the production and price of which is the same as previously stated. This coupling element must be welded with both a polyolefin bag and a PVC hose, which creates weight during the production process and, in addition, increases the cost price. It should be noted, in particular, that some of the proposed solutions work with PVC connection hoses that normally have fabric softeners and have so far been considered unacceptable.

Description of solution to a technical problem

The technical problem is solved by the invention thus, which is of polyolefins such as, polyethylene, propylene, poly-n-butylene, polyisobutylene, poly-4-methylpentene-1, chlorosulfonated polyethylene, polystyrene, halogenated polyethylene or polymethylacrylate and their copolymers. or mixed polymers, a fabricated bag on its edge welded with an insert of a dying copolymer of olefins and vinyl acetate.

It has been found that if ethylene-vinyl acetate (EVA) copolymer is used, as the VAC content increases, the elasticity of the bounce increases on the one hand and the melting temperature drops below 100 ° C on the other, so that sterilization of one such bag with such a coupling part gut, no longer possible.

It is known, however, that polyolefin-based intestines containing VAC by crosslinking can be thermally stabilized and their elasticity can be improved. On the other hand, it is known that these cross-linked intestines can no longer be welded to bag materials.

According to the invention, it is found that the polyolefin bag can be welded with a non-crosslinked olefin copolymer, in particular ethylene and VAC. After copolymer crosslinking, this compound can no longer be separated. The mechanical properties of the starting product are still retained in this end product.

It should be noted, in particular, that such pieces of intestines, which are welded into the polyethylene bag as outlet tubes, have significantly good elasticity and temperature behavior, so sterilization up to 120 ° C is possible.

The bags according to the invention do not contain a softener, so the effect of microorganisms is significantly reduced.

As mentioned, olefin polymers such as ethylene, propylene, butylene and the like are used to prepare the bags according to the invention. It is preferably olefin, ethylene which can be substituted by one or more groups as e.g. methyl or ethyl group, vinyl group and halogen atoms and in particular fluomic atoms. Styrene or polyacrylonitrile may be added to the substituted ethylene compounds.

According to the present invention, polyethylene is primarily used as a polyephole bag material which may have limited vinyl acetate additives in the form of copolymers of ethylene and vinyl acetate, e.g. up to 10 wt. % of vinyl acetate.

In particular, medium to high density (SG and VG) polyethylene is obtained which is obtained in the usual way by low pressure polymerization. For density, the density lies in the range of 0.9 to 0.94, optimally 0.935 g / cm.

The polyethylene used has high molecular weight and narrow molecular weight distribution. In any case, care should be taken to ensure that such polyolefins do not have a melting point below the sterilization temperature of 110-120 ° C. Primarily, the melting range should be below 116 ° C, especially at 120-124 ° C, while the Vocat softening temperature according to OIN 53460 should be above 115 ° C.

Permeability to water vapor and even oxygen to these olefins can be a problem with the solution, so either the concentration in the solution or the oxidation of the solutes may occur. The latter is particularly critical in amino acid solutions and must therefore be completely excluded.

To solve this problem, the polyolefin bag is coated on the outside with one or more layers, laminates that reduce the permeability to water vapor or oxygen. The coating is done with a metal foil or other polymer. Such a lining can significantly increase the mechanical resistance of such a bag, “which does not fire when falling from a height of several meters.

Any of the above polyolefin can serve as a polymerisate for the production of such a laminate. Preferably such polymers are used which have low permeability to water vapor and oxygen. These include polyamides, PVC, polyvinylidene chloride, polyvinyl fluorine, polytrifluorochloroethylene, polyethylene terephthalate, polyester and the like. Polyamide, polyvinylidene chloride, polyethylene terephthalate and polyester are particularly recommended.

The outer and inner foils are suitably glued with a paste adhesive such as polyvinylidene chloride or single polyurethane. The polyurethane adhesive can be a two-component adhesive, the first component being a kashimi adhesive and the second component an additional adhesive.

The polyolefin inner film may be extruded, gut-shaped, and lined using a pre-selected laminating adhesive, preferably using polyurethane adhesive. If PVC is used as the outer film, the safety of the polyolefin film is that the softeners contained in the PVC cannot pass through the glue and polyolefin film into the solution contained in the bag.

Laminates exhibit a temperature of about 23 ° C and a relative air humidity of 85%, generally permeable to water vapor less than 1, per BIN 53 122.

These values apply to standard films of 50-100 µm thickness, especially 75 µm, to a 20-100 wn polyolefin film, especially 30-70 µm and to a polymorphic foil such as polyamide.

In addition, the permeability for oxygen is reduced for such laminates, where 3 2 this value lies below 15 cm / m x day x bar of the pressure difference.

As previously determined, the liquid-facing polyolefin film contained in the bag does not have softeners or additives that can be physiologically hazardous and, above all, diffuse into aqueous solution. In this case, the polyolefin film is glued with an organic porridge film and is clear and shows these properties after sterilization.

An olefin copolymer with vinyl acetate was used as the exit material. The polyolefins derived from this olefin are already considered olefins for the production of bags. These olefins have vinyl acetate content in a copolymer of 5-40 weight. %, preferably 8-35 wt. %, especially 20-32% by weight. As previously clarified, the melting point of polyethylene decreases with increasing vinyl acetate content from about 125 ° C to about 70 ° C, when about 30 weight is present. % VAC. This gut naturally melts when sterilized above 100 ° C and is therefore unusable. On the other hand, the required elasticity to bounce these bowels, with an increase in VAC content from 35% to 55% at 30% VAC content.

In addition, such a gut material with VAC content can be easily welded with the bag material as long as generally similar or even the same polyolefin materials are used. The use of substantially the same polyolefin materials for the bag attachment is therefore paramount. Preferably, the ethylene-vinyl acetate (EVA) copolymer with the weight ratios indicated above is used as the outlet material, with suitable polymers of ethylene or propylene compounds being considered as the bag material. Particularly suitable is a combination of EVA as an outlet material and polyethylene as a bag material in the above relationships.

EVA is manufactured e.g. by Hoechst AG under the name Hostalen LD / EVA and ICI under the name Evatane and Alkathene EVA.

The production and processing of bags is carried out according to the usual procedures in the plastics industry. Thus, e.g. bags can be obtained, as mentioned, by extrusion of the foil in the form of intestines, by appropriate seating of the foil, and finally by welding the edges. The bag where the edge is left unsecured due to the outlet opening is eventually welded with one piece of gut or outlet insert. This insert is inserted into the bag using a punch. This is then followed by a warming on the edge with the worm insert.

The bags thus obtained exhibit generally the same properties as PVC bags, with the exception that the intestinal extension consisting of EVA when sterilized above 80 ° C melts and therefore sterilization of such a bag is impossible. On the other hand, the welding spot between the bag and the gut insert that has been created is so strong that only a violent removal of this gut is possible.

In order to allow sterilization of the gut insert, this piece of gut from EVA must be immersed, thereby significantly increasing the melting point of the gut and its elasticity. It is thus possible to sterilize the bag thus obtained at temperatures up to about 120 ° C. In addition, a wrinkled bowel has significantly better elastic properties than PVC bowels, which must be heated in order to get used to certain connections.

According to the invention, it is found that this crosslinking does not reinforce the aforementioned welding site, what could be assumed is that the crosslinked EVA gut with the polyolefin material itself e.g. with polyethylene I cannot weld.

Networking can be done by known treatment for EVA networking. It can be e.g. be done by irradiation with energy-rich rays, e.g. with accelerated electrons & C and (ίο rays with energies above 2.5 Mrad. Primarily, depending on the material used and its thickness, with values from 5 to 10 Mrad,

This treatment has the advantage of sterilizing a row of a warmed bag that is largely free of pyrogenic bacteria, thus allowing the filling of an already sterile solution, which means that one heat treatment in the autoclave is wasted. Further, this radiation treatment 'has the advantage that one polyethylene incompletely polymerized or low EVA foil obtained is crosslinked and their mechanical resistance is increased so that a sterilization temperature of up to 130 ° C is achieved.

A further networking process is peroxide treatment, e.g. with cumolperoxide and the like, which, upon heat treatment, decompose and initiate radical crosslinking. In this case, the production of EVAs, which are usually obtained in heat, must be combined with the production of bags, since EVA material would cross-link and would not be welded with polyethylene as a bag material.

Another networking process that is also based on the addition and decomposition of chemical compounds consists in the addition of silicon organic compounds which, when decomposed in a humid and warm atmosphere, are crosslinked with EVA, wherein Si crosslinking is so-called. The sioplas process is ICI, and the silica organic compound is mixed into the EVA granulate and the resulting product is extruded into foils or casings. This is where networking occurs during the hours to days depending on the degree of humidity and temperature chosen. Thus, the crosslinking can be performed in one hour, when done at a temperature above 80 ° C and a relative humidity of 100%.

Of all the networking procedures described, procedures for irradiation with energy-rich radiation and treatment with organo-silicon compounds which are networkers are particularly suitable. It should be noted that any crosslinking process, not yet crosslinked and for the bag material of a welded polyolefin gut, with a specific VAC content which crosslinks after welding may be used.

The bag according to the invention will be shown more closely on the sketches and in the following description, wherein:

FIG. 1 shows a bag for infusion purposes in a horizontal projection of FIG. 2 shows a cross-section of II-II in FIG. 1, FIG. 3 shows a jefan shaped opening of an EVA gut insert, FIG. 4 shows a fragment of a horizontal projection of another embodiment of an insert with an intestinal insert without a safety cover.

FIG. 5 is a cross-sectional view taken along line V-V of FIG. 4, FIG. 6 shows a further embodiment similar to the embodiment of FIG. 4 and the like. 7 shows in cross section the wrapper of the gut insert.

The bag 10 consists of a chamber 12 which is circumferentially closed by the edge 14 which is welded, and on one side has outlet openings 16 and 18 connected to the insert 20 and 22 in the form of a bowel. Through these inserts 20, 22 the liquid stored e.g. insert infusion solution or blood into chamber 12 of bag 10.

This type of bag 10 is obtained when the foil needed to make the bag 10 is placed on top of one another and then welded to the edge 14, leaving openings 16 and 18. Inserts 20, 22 are inserted into these openings by means of a gut with the aid of a puncture , which is not shown and then welded along its outer edge. As mentioned, ethylene is primarily used as the bag 10 material, welded with additional EVA as gut material, and finally crosslinked with EVA by primarily ionized rays.

For infusion purposes, the insert 20 is coupled to a stopper 23, the end of which is provided with a sterile, penetrating membrane 24 made of chlorbutyl rubber. This membrane 24, which is normally attached to the polycarbonate stopper 23, is covered for hygienic reasons by a pit 25.

The second insert 22 may be connected to an injection stopper 26 which is also made of polycarbonate and consists of a single puncture insert made of latex. The plugs 23, 26 inserted into the EVA insert inserts 20, 22 can be very difficult to remove with a large screw, indicating that this is a secure seat.

As the bag 10 is normally hung downwards with inserts 20, 22, so that the solution which filled the bag 10 can easily flow out, on one edge 14 there is an opening 28 about which the bag 10 hangs.

Bag 10 as shown in FIG. 2, consists of SO laminates and laminates which are in contact with the solution, i.e., on the inside of the bag 10 are polyethylene film 32 SO - 100 pm thick, preferably 75 pn. Polyethylene has a density of 0.935 g / cm, preferably a melting range of about 121 - 124 ° C and a softening temperature of about 118 ° C. This polyethylene film 32 was bonded with a polyamide film 34 by means of a polyurethane adhesive, the film 34 being typically 30-70 yuan thick.

As can be seen in FIG. 2, the polyethylene film 32 has a welded seam 36 in the transition region towards the inserts 20, 22, which provided an internal connection between the foil and the inserts 20, 22, such a connection that, when tearing the inserts 20, 22, the bag 10 is destroyed.

In FIG. 3 shows one embodiment of the inserts 20 and 22, in FIG. 3 shows only the end of them, without the area of the suture of the mother bag. The edge 38 of these inserts 20, 22 has a diaphragm 42 extending near the introductory end 40, which extends over this introductory end 40 and serves to seal the interior of the bag tightly against environmental influences. This diaphragm 42 is punctured with the tip of the infusion device not shown, so that the contents of the bag 10 are swollen through it. The introductory end 40 of the inserts 20, 22, for better sealing, is further made with a thickening 44 which is of annular shape. Since the membrane 42 must remain sterile after sterilization in the autoclave, the inlet end 40 is covered by a closing strip 46 that is removed during use.

In the case of insert 20, 22 according to FIG. 3, the edge 14 of the bag 10 must, of course, be made with a special filling opening 48, as shown in the illustration in FIG. j and which, as well as openings 16 and 18, must be provided before welding in the manufacture of the bag 10. Through this opening 48, the bag is filled and can be welded or sealed in the usual manner.

Another embodiment is shown in FIG. 4 and 5. Provided here is an insert 50 consisting of a body 52 which is as in FIG. 4 shows a lenticular shape. This shape facilitates welding with the inner foil 32 at the edges so as to obtain a continuous transition between the edge 14 and the body 52.

The body 52 according to the embodiment shown in FIGS. 4 and 5 is provided with inlet and outlet openings 54 and 56. In addition, it is provided thereon. filling opening 58 according to the following criteria. The outlet and outlet openings 54 and 56 are each connected to one tubular connection 60 and 62, each of which can be shaped according to FIG. 1 or 3. These may again be provided with diaphragms 64 and annular thickeners 66, requiring a filling opening 58 that can be securely closed by a suitable buckle.

The embodiment shown in FIG. 5 has connectors 60 and 62 whose edges are connected through a cut line 68, each with its cover 70, which on one side keeps the membrane 64 sterile until use, and on the other can be easily removed before use.

Of course, it is possible to perform according to FIG. 4 and 5 also be performed without membranes 64 and thickening 66, as well as without lids 70, wherein the filling opening 58 is redundant. Of course, it is also possible to provide terminal 60 or 62 ie. just one or more of them.

In FIG. 6 shows a further embodiment of such an insert 72 which is also a lenticular body 74, similar to that in FIG. 4. The thickness of these bodies 52, 74 should be chosen to suit the thickness of the edge 14.

In the body 74 shown in FIG. 6, the tubular connections 60, 62 seen in FIG. 5, so that this body 74 is provided with only the inlet and outlet openings 76 or 78, into which inserts 23 or 26 according to FIG. 1. The openings 76 and 78 may also be closed as in FIG. 3, therefore, a membrane 80 may be provided which will be primarily mounted on the lower surface of the body 74.

In this case, a filling opening 82 is again provided, which in FIG. 6 shown by dashed lines, which may be closed by a suitable buckle. The inlets and outlets 76 and 78 may be covered with a sterile removable foil.

FIG. 7 shows a cross-section of another embodiment corresponding to FIG. 1 and showing only one tubular connection 84 which is welded to the bag 10 in the region of the edge 14.

The embodiment of the bag 10 in FIG. 7 corresponds essentially to the one in FIG. 1, the face being on both foils constituting the bag 10, the area 86 in the form of a tongue which, when properly welded at their edges 88, 90 and 92, will comprise a fully sealed tubular connection 84. This is tubular. terminal 84 constructed and closed with diaphragm 94 and corresponding thickening 96, sealed sterile to the outside after welding.

The edge 14 is first welded to the area 98 when making the bag 10, so that the area 86 formed from the two tabs remains open. Further, the & open area 86 introduces port 84 in the edge area 14 so that the edge 14 closes completely. The still open area at the edges 88, 90, 92 is subsequently welded, as shown in FIG. 7 wherein the inner space 100 of this area 86 remains unprotected.

At the junction between the inner space 100 and the edge 92, a cut line 102 is provided, which at the appropriate stress of the edge 92, which is conveniently shaped like a gripper, is cleaved, whereby the edge 92 can be completely removed.

Of course, multiple ports may be covered by area 86, or multiple areas 86 may include each of their ports 84. For example, the embodiment of FIG. 1 may be provided with two separate ports in two areas 86 and one filling port 48 not covered by these areas. On the other hand, all three openings to the bag 10 can be completely enclosed in one area, this type of welding being independent of whether the connections are closed, driven by a diaphragm or hollow stoppers.

As the material for inserts 20, 22 and inserts 50, 72 as well as attachment 84, EVA with a VAC content of 25-35 weights is used. %, with the products listed as '' Hostalen, Evatane or Alcathene.

After crosslinking, for example, irradiation (3 rays or the Sioplas process, a crosslinked tubular insert or attachment is obtained, which can be sterilized and at a temperature of at least 120 ° C. At friction, the weld seam 36 is not removed before welding. .

Dos. 3488 / * Mrli.9 £ F-19′S6S

Claims (11)

Patent claims 1. Luggage bag, in particular for storing blood or infusion solutions, made of organic polymer material with at least one extrusion insert 50,72, consisting of polyolefins such as polyethylene, polypropylene, poly-n-butylene, polyisobutylene , poly-4methylpentene-1, chlorosulfonated polyethylene, polystyrene. halogenated polyethylene or polymethylacrylate as well as their copolymers or mixed polymers, fabricated sack (10) on its edge (14) welded with an insert (50, 72) of a dying copolymer of olefin and vinylaoetate. 2. A bag according to claim 1, characterized in that the polyethylene is dense 3 3 not 0.9 - 0.94 g / cm, optionally 0.935 g / cm with the addition of vinylaoetate up to 10 wt. % Bag according to claim 2, characterized in that the polyethylene is in the form of a foil and which is coated with foils of polyamide, polyvinyl chloride, polyethylene terephthalate and polyester. Bag according to claim Ido 3, characterized in that the laminate is made of polyethylene foil and pulp foil with a thickness of 200 jim, wherein the polyethylene foil has a thickness of 50-100 jim and a foil film with a thickness of 20-100 jan Bag according to claim Ido 4, characterized in that the insert (20,22, 50, 72) consists of copolymers of olefins and vinylaoetate having a vinylaoetate content of 5 - 40 wt. %, preferably 8-35 wt. %, especially 20 - 32 wt. %. 6. The bag according to claim 1, characterized in that the inserts (20, 22, 60, 62, 84) or openings (76, 78) of insert (50) retracted stopper (23, 26). Bag according to claim 1, characterized in that the inserts (20, 22, 60, 62, 84) or openings (76, 78) closed by membrane (42, 64, 80, 94). Bag according to claim 7, characterized in that a welded filling opening (48) is provided at the edge (14) of the bag (10) and a stuffed opening (58, 82) is provided on the insert (50,72). . 9. Bag according to claim 7, characterized in that a ring thickening (44, 66 96) is performed against the diaphragm (42, 64, 80, 92) at the insertion end (40) of the insert (20, 22, 60, 62, 84). ). Bag according to claim 1, characterized in that the inserts (20, 22, 50, 72) are closed by a detachable lid (46, 70). Bag according to claim 1, characterized in that the inserts (20, 22, 50, 72, 84) are closed by an area (86). FKESENIUS AG, Bad Honiburg, Germany Summary of the essence of the invention The invention relates to luggage bags, in particular for storing blood or infusion solutions, in which bags 10 are made of polyolefin as polymer, and with inserts 50, 72 a bag 10 of a dying copolymer of olefin and vinyl acetate. Polyephalein has a density of 0.9 - 0.94 g / cm, with the melting point of polyethylene above 116 ° C. Inserts 20, 22, 60, 62, 84 or 76, 78 inserts <. towards 50, a stopper 25, 26. is retracted, the latter being sealed by membrane 42, 64, 80, 94.