MXPA00004412A - Tank for administering flowable substances - Google Patents

Abstract

The invention relates to a tank (100) used to administer flowable substances, characterised in that (a) the tank (100) has flexible walls (2&3);(b) the walls of the tank are single-pieced or joined to each other;(c) the walls (2&3) of the tank form a closed container having at least one opening;(d) the walls of the tank (2&3) are partially joined to at least two flat vertical elements (6) which are separated from the walls of the of the tank in the fixed area of said walls (2&3);and (e) the opening (12) has one closure (13). At least parts of the walls of the tank (2&3) and/or vertical elements (6) are made of composite material and consist of (i) plastic laminate or (ii) at least one plastic laminate and an aluminium laminate whereby said laminates are joined to each other. Preferably, the tank is designed to receive contrast agents.

Description

DEPOSIT FOR ADMINISTERING FLUID SUBSTANCES Description of the invention The invention relates to a reservoir for administering fluid substances. In particular, it is in this case bags that are filled with pharmaceutical substances, preferably contrast agents. This application claims the priority of the filing of 14.11.1997 in the German Patent Office with the registration number DE 197 51 406. For the .E.U.A. also the USA presentation of 2.12.1997 with the registration number USA 60 / 067.342. State of the art In the US patent document US ,295,967, which was published on March 22, 1994, describes an adequate deposit for the administration of infusion liquids. A reservoir of this kind comprises flexible walls of the reservoir which are welded to one another in the edge areas. By this the walls of the tank form a closed tank having two openings in the lower zone. One of these openings is communicated with the infusion instruments. The opening that is attached to the infusion set is located at the bottom of the tank. The tank can be hung, since in the upper area of the tank the front and rear walls of the tank are welded together and, in the area of the weld, it has a perforation that allows the entire tank to hang. In addition, the deposit comprises a scale that extends from top to bottom and is printed on the deposit. Deposits within which liquid detergent is found are also known from the detergent industry. Such bags have an opening which, contrary to the previous one, are in the upper area of the tank. Such bags have a front and a rear wall of the tank, a front wall and a back wall, all of which are flexible. They are welded together in the edge areas. The walls of the tank are surrounded by support elements, which in the area of sustentation are separated from the walls of the tank. The supporting elements are also welded to one another in the lateral and upper areas, so as to form a bag. Only in the bottom area, that is, in the lower area, the support elements are not in contact when the bag is in a full state. In this area the two support elements are joined to one another through the walls of the tank, which in this case form sections of the bottom of the tanks. Commonly these types of bags are printed with colors and symbols. The disadvantage of these bags is that the corresponding materials are not acceptable for pharmaceutical and diagnostic substances. Also the printing process is problematic. Task and solution It is therefore the task to provide a tank with flexible walls of the tank in which the tank has a sufficient stability of support to be able to maintain the verticality safely on a relatively small surface in a full or half-empty state. In addition, the deposit must be acceptable for pharmaceutical and diagnostic substances and be able to empty without problem. The task is solved by a deposit to administer fluid substances in which the deposit comprises the following characteristics: (a) the deposit has flexible deposit walls; (b) the walls of the tank are in one piece or joined with one another; (c) the walls of the reservoir conform at least parts of a closed reservoir, reservoir having at least one opening; (d) the walls of the tank are joined with at least two two-dimensional supporting elements, which in the area of sustentation are separated from the walls of the tank; and which are eventually parts of the closed tank; (e) the opening comprises a closure and a connection, preferably a double closure, wherein (i) parts of the walls of the tank and / or of the support elements are made of a material comprising at least one laminate of synthetic material, optionally a composite material, and that (ii) the other parts of the walls of the tank and / or of the support elements are made of a composite material comprising at least one laminate of synthetic material and an aluminum laminate, the Laminates are firmly attached to one another. Advantages The invention has several advantages. Flexible tanks are very desirable, they are easy to handle, their storage capacity and their handling do not cause problems. If the walls of the tank are sufficiently stable, an opening by tearing the tank is impossible. It is also convenient to be able to resort to materials that are already widely spread in the pharmaceutical industry. The infusion bags have been used for a long time also in blood transfusions. However, they are made of PVC material, which is very controversial due to the ecological aspects. It is convenient that the bags and tanks according to the invention be placed vertically without problems. Since placed vertically they occupy little place. It is possible to deposit significantly more deposits safely on one and the same surface than would be possible with flat bags. If at least parts of the walls of the tank or of the support elements consist of composite material with aluminum, then it is possible to print the respective tanks without problems. With this, the advantage is obtained that no deposits can be introduced into the interior of the deposit or adhesives, which must be used in the case of labels, or dye residues. Contaminations of this nature become justly problematic and occur precisely when the fluid substance, for example the contrast agent, must be stored for prolonged periods. An aluminum laminate successfully prevents the filtration of the dyes. In addition, this ensures that the deposits can be printed irreparably. It is convenient that in addition to two-dimensional printing, letters or symbols can also be printed in relief. By means of this, an unambiguous association between the contents of the tank and the external surface of the tank is possible. By this it is impossible to confuse the deposits. Consequently, a markedly greater safety in the application of these deposits in the area of medicines and the field of diagnosis is obtained. The aluminum laminate also protects the contents of the environment tank. The release of drug components and the entry of foreign substances into medicines are largely prevented. It is also possible to dispense with a protective packaging for the bag with a support floor during the storage of the medication. In the case of repeated use (partial extraction) the contents of the bag are sufficiently protected by the aluminum compound. By virtue of the transparency of the front walls of the tanks, optical control is possible immediately after filling with the pharmaceutical manufacturer and by the doctor before use. It should also be noted that the opening of the deposit is protected in multiple ways. The complete opening with screw and valve closure is surrounded by a protective film that forms part of the walls of the tank or is attached to them. Definition A reservoir is a container in which fluid substances can be accommodated. The essence of the deposit is that it can permanently shield the fluid substances from the outside environment. It is also important that the deposit prevents an alteration of the enclosed fluid substances. Thus, for example, pharmaceutical substances and also diagnostic substances must not undergo chemical changes. It must also be prevented that substances enter the tank and either dissolve in the fluid substance or mix with it. In principle, the deposit form is not established, but here the practical reasons, such as storage and outflow, intervene. Thus, for example, during emptying, it must be ensured that all fluid substance can leave the tank. The formation of cavities and folds of which the fluid substance can not escape must be avoided. It is also necessary to observe in the tank that it can be easily manufactured and easily filled with the fluid substance. The walls of the tank fulfill the task of separating the fluid substance from the environment, and preventing the fluid substance from escaping. Conversely, it must also be avoided in the same way that substances from the environment can penetrate into the fluid substance. The walls of the tank are flexible to the force application of the operating personnel. Only when the tank is stopped on the supporting elements should the supporting elements be rigid with respect to the static forces of the tank. It is desirable that the walls of the tank be impermeable to both liquids and gases. In this we must also take into account that the diffusion of gases happens almost through any material. It is essential that the diffusion of gases be so reduced that the fluid substance does not undermine the interior of the tank. This also should not happen in the event that the fluid substance in the tank is stored for a longer period, such as one to two years. It is essential that the walls of the tank are constituted by substances that, while increasing flexibility, can not penetrate the fluid substance. Thus, for example, synthetic substances also contain softeners. These softeners must be able to penetrate in an insubstantial form and quantity in the fluid substance. The concept of fluid substances covers all pharmaceutical and diagnostic substances. This comprises drugs including their pharmaceutically acceptable vehicles and auxiliaries. Frequently it happens that in addition to a liquid gases are also found in the form of a gas bubble in the tanks. In addition to liquids, the term fluid substances consequently also includes solid and gaseous substances. Mixtures of this kind are illustrated in W. Schroter et al .: Chemie, Fakten und Gesetze, Leipzig 1987, 14. edition, page 24. Suspensions, emulsions and colloidal solutions such as liposomes are also of interest. Through the opening it is possible to fill as well as empty the tank. In this case it is possible to fix a filling opening and a drain opening independent of the tank to the tank. Preferably the openings are welded with the entire tank, in particular with the walls of the tank. The openings should allow the infusion set including a pumping device to be connected without problems to the tank. The openings should be sized to allow flow rates of 2-10 ml / sec through the openings. Preferably these openings are sterilized or are protected against contamination by closure caps. Only after removing these closure caps it is possible to connect the infusion instruments or the connection of the pump to the opening. It is imperative to take care of extreme sterility, since it is necessary to bear in mind that the deposits once opened must remain free of contamination for several hours and even for several days. The support elements fulfill the task of providing the tank, which is preferably constituted by two tank walls welded together, such a stability that this tank can remain supported safely even standing vertically. The vertical stop shape is defined in that the bag comes to rest on a ridge, preferably the edge having the shortest length and opposite to the opening being chosen. In this the support elements conveniently comprise a piercing that does not compromise the hermeticity of the tank, but that nevertheless allows to hang the whole deposit. By this it is possible to allow the tank to empty through the opening. With this it can be seen that the opening should be as far as possible opposite the suspension device. The support elements are preferably less flexible than the walls of the tank. They must be attached to the walls of the tank at least in small areas to incorporate a corresponding stiffness. In this, a durable and safe transition between the tank wall and the support element must also be ensured. It is not necessary for the support element to be in contact with the floor throughout its entire length, but nevertheless it must be guaranteed that even with few points of contact with the floor, a sufficient stability of the deposit is ensured. The support elements can also be manufactured in such a way that they replace the walls of the tank practically in their entirety. Then, only in the area of the support, that is to say in the lower area of the tank, there are walls of the tank attached to the support element not directly, but through a welding seam or a glue seam. Rather, the walls of the reservoir between the support elements are constructed in the support area so that sealing elements extend between the support elements. In this it is convenient if the surface formed by the walls of the tank in the lower area of the tank behaves like a fold which in the folded state is oriented upwards towards the opening. If the tank is filled, then this fold constituted by the walls of the tank unfolds downwards and forms the bottom of the tank. In other words, it is fundamentally possible to interchange the support elements and the walls of the tank in many areas in many areas. The essential thing in this is that 'however, the functions are guaranteed. The walls of the tank serve to prevent the penetration of liquids and gases. The support elements fulfill the function of providing the tank with sufficient stability, so that it can stand vertically with safety on the support elements. The extent to which the support elements and the walls of the tank extend can be randomly varied in shape. However, it is essential that the support elements can be separated from each other spatially in the lower area facing the floor. In the area of contact with the floor they must delimit and surround a support surface. Plastic laminates are two-dimensional synthetic substances that are described in detail in the Ropp-Chemie-Lexikon, authors Jürgen Falbe and Manfred Regitz, 9. edition, Stuttgart 1990, page 2398 et seq. The softeners and additives are automatically counted among the synthetic substances. Synthetic substances must have the property of being flexible to the forces that arise with the operating personnel. In the case of static forces that exist with a single reservoir standing vertically, the supporting elements must be substantially rigid in relation to the sustenance surface. Simultaneously, the synthetic substances should in any case have a sealing function, so that liquids and gases can only seep through these laminates of synthetic material in an insignificant way. Laminates made of synthetic material can have a variety of transparency, totally transparent laminates are preferred. The plastic laminates of preference should be able to be welded or bonded, so that it is possible to seamlessly join the wall portions in the edge areas of the deposits with one another. At least part of the walls of the tank should be covered by an aluminum laminate. In this case it is an additional laminate that is on the laminate of synthetic material. This represents the advantage that the gas permeability in this part of the tank is thereby reduced. further, the aluminum laminate allows the aluminum laminate to be printed on the non-oriented side to the fluid substance. Printing inks and solvents can not be filtered through the aluminum laminate, so that it is impossible to endanger the fluid substance. This also ensures that the registration is firmly attached to the deposit. It is no longer possible to remove the registration of the deposit without destroying the deposit itself when trying. Through this, the impossibility of confusing deposits and registrations is guaranteed. Accordingly, the aluminum laminates show impressions which, in the case of inclement weather or wetting, would have made the otherwise usual labels unreadable or detached. Since aluminum is relatively rigid and can be stamped, the letters and symbols can also be printed with the print, so that even after the color is lost, the print remains readable. Aluminum additionally has the advantage that a specular effect occurs in the area oriented towards the fluid substance. Due to this, the observer can immediately observe the content of the tank critically when the wall opposite the aluminum laminate is made of totally transparent material. It is therefore possible to immediately detect the consistency, possible impurities or problems in the tank. Other embodiments A reservoir according to the invention is convenient in which the walls of the reservoir comprise a front wall and a back wall. This is a very simple method especially with regard to manufacturing. Two walls, specifically the front wall and the back wall are placed one above the other and welded together with one another in the external areas, whereby a notch for the opening is provided. In addition to welding, it is also possible to glue the walls. Such folded bags hardly and occupy space when they are empty. But by virtue of the supporting elements a reservoir of this kind however is well trained to stand vertically on a flat surface when full. Therefore, the functions of stability and minimization of the space requirement in the empty state are combined. By virtue of the flexibility, convenient storage of the filled tanks is also possible. It is possible to stack without problems one on top of another different deposits. A tank is preferred in which an aluminum laminate is provided in the back wall, the front wall being transparent. The combination of the possibility of printing and the transparency of the opposite wall of the deposit is the most convenient. Ensures that the deposit can provide an unambiguous identification. It is no longer possible to confuse substances and deposits if the otherwise usual precautionary measures are taken. In this case, the aluminum laminate can be large enough to carry a corresponding label and other coding systems. On the inner side of the aluminum laminate oriented towards the fluid substance, a scale can be found in which it can be read that volumes are still inside the tank. Another very convenient embodiment consists of a tank whose front wall is made of polyester-propylene and the dorsal side of polyester-aluminum-propylene. In this case it is a question of several layers that are joined to one another by welding. They are formed with this what is known as composite films. Preference is given to tanks according to the invention in which a laminate of synthetic material is provided on the aluminum on the non-oriented side towards the inside of the tank. By this a protection against a tear is obtained. The deposit acquires a noticeably greater tear resistance on the surface. Thin aluminum laminates having the above advantages can easily be torn by mechanical effects. To prevent this and not dispense with the advantages mentioned above, the additional protective layer of synthetic material is provided in the tanks. In addition, this deposit presents a considerable advantage during manufacture. Such external surfaces can be welded or glued easily without having to resort to high temperatures. In this, it is convenient if the laminate of external synthetic material is provided in the tanks at least in the areas of the sealing seams. More preferred are those tanks in which the internal laminate (oriented towards the inner space of the tank) is at least propylene, the intermediate aluminum laminate and the external laminate of transparent synthetic material. The three layers are functional. They correspond to synthetic material, aluminum and again synthetic material. Above all, the tanks in which the external laminate is made of polyester and polyamide are preferred. In this case, they are particularly suitable materials. The tanks according to the invention are convenient in which the walls of the tank are more flexible than the support elements. This ensures that the tanks can be stopped vertically regardless of the filling volume. However, two filling conditions are preferred; on the one hand the completely empty state and on the other hand the tank completely full. It is in these two conditions that the deposits are usually handled by the operating personnel. Partial partial filling states only occur when the deposits are extracted a corresponding amount of fluid substance, which happens when the tanks are commonly emptied in hanging form. When doing this the opening always comes to be in the lowest place of the deposit. Deposits in which the walls of the tank are resistant to expansion are convenient. By doing so, it is successfully avoided (guaranteed) that even in the case of higher pressures, such as those that may occur in stacks or with momentary loads, the deposits with respect to the walls of the tank can not be torn. This is a desirable form of security that ensures that the tearing of the walls of the tank is avoided in a controlled manner. In addition, the resistance to expansion ensures that the deposits can also be stored stacked in certain storage locations. This also avoids problems during filling. More preferred are those tanks according to the invention in which at least one suspension opposite the opening is provided in the tanks. Mediane this ensures that the content of a deposit can be extracted completely. A suspension of this kind can have different designs, it can only be an eye or a hole that is in the wide weld seam of the walls of the tank. However, it can also be an additional material joined two-dimensionally to at least one of the walls of the tank. But the suspension can also consist of a bayonet or coupling closure that can be connected to a corresponding complementary suspension of a frame. In practice it is convenient to arrange the suspension and opening diagonally opposite. A reservoir according to the invention is convenient in which the closure is a threaded cap with an original closure and / or a closure that can be opened by means of an adapter. By means of this it is assured on the one hand that the extraction can be carried out only once and on the other hand the guarantee of sterility. The problem of sterility is a serious matter and the corresponding solutions are convenient. Above all, the tanks according to the invention are preferred, in which the opening including the closure is surrounded by a protective film that is part of the walls of the tank or is attached to them. This ensures that after a sterilization process that is carried out after filling a sterilized closure is also preserved in this condition. In this way it is ensured in the best way that a contamination of the connecting element that is connected with the pump or the infusion instruments is prevented. It is convenient a tank in which the tank can be sterilized thermally. In this, it should be a sterilization that is carried out both before filling and after filling. After the deposit is partially welded it is possible to purify the deposit of exotic bodies. As sterilization processes are particularly suitable: sterilization by radiation or chemical sterilization processes. As chemical sterilization processes, the treatment with ethylene oxide, propan-3-olide and diethyl carbonate, as well as hydrogen peroxide and a mixture of ozone / steam are known. Likewise, sterilization with high energy radiation is possible. In this, gamma rays and X-rays are known. An alternative is the production in aseptic enclosures. Thus, the first sterilization steps can be dispensed with. Eventually the tanks are packaged sterilized in bacteria-tight but gas-permeable film, or aluminum. The sterilization is carried out with the aid of thermal and / or chemical sterilization, with gamma rays or X-rays, neutron radiation or beta rays or a mixture of the previously mentioned radiations. The treatment with hydrogen peroxide or ozone / steam is preferred. In the next stage the tank is sterilized in the autoclave or the sterilizer with hot air or by microwaves. Eventually it is possible to form a support pressure in the sterilization chamber of the autoclave or in the sterile chamber by means of a gas, whereby the pressure on the external surface of the reservoir is greater, equal to or less than the pressure on the internal surface of the reservoir . The support pressure is defined as the pressure that corresponds to the sum of the partial pressures in the sterile chamber minus the partial pressure of the vapor. It is particularly important to pack sterile containers in a rack, and sterilize the full container. This process can be done in a sterile chamber. This stage is particularly convenient since * it allows the security of offering the doctor in charge of the treatment a deposit that is also sterile on the outside. By this, the danger of contamination can be reduced. Frequently the deposits that are emptied mechanically are used in sterile operating rooms. Only sterile or disinfected materials are allowed in these rooms. Therefore also a deposit that is emptied in mechanical form must be absolutely sterile on the outside. Those deposits in which the fluid substance is a drug or diagnostic agent are very preferred, with a reservoir being preferred above all in which the diagnostic agent is a diagnostic agent that produces an image. In this it is the following contrast agents with the generic names: amidotrizoic acid, gadopentético acid, gadobutrol, gadolinium EOB-DTPA, the ami ol, lopromide, lotrolan and lotroxinic acid. EXAMPLE The invention is reproduced in an exemplary manner in the drawing. In this figure figure 1 represents a deposit illustrated in the way it stands vertically. Figure 2 shows a reservoir in the suspended form, in which the reservoir is suitable for emptying the fluid substance. In figure 1 a tank 100 can be seen.

The observer looks over the front wall 2, which is transparent. Here the front wall could also have only one transparent strip, being that the rest of the surface could be coated with aluminum. By both variants it is possible to see the back wall 3, which is attached to an aluminum sheet through the entire width and through the length A. The aluminum sheet lies on the outside on the synthetic film of the wall 3 dorsal. The front wall 2 and the back wall 3 are connected to one another through the welding seam 4. This welding seam 4 has different thicknesses. In the area of the longitudinal side A the welding seam is relatively large compared to the welding seam in the area 5 of the bottom. Here they face directly against each other the front wall and the back wall, here there is no aluminum. In a variant that is not shown in the figure, the bottom can also be aluminum, whereby the aluminum coated surface is maximized and simultaneously optical control is guaranteed through the front wall. In the area C through the entire width of the tank 100 is the support element 6. In this, the support element 6 comprises a front support element 8 and a rear support element 9, both joined to one another through the welding seam 7. In the area of the line 10 the front wall 2 and the back wall 3 are joined to the front support element 8 and the rear support element 9. In this, the front support element 8 and the front wall 2 come into direct contact, and also the rear support element 9 and the rear wall 3. The front support element 8 and the rear support element 9 have a half-moon-shaped recess 10. In this zone, the part of the idealized rectangular support element is replaced either by the front wall 3 or by the back wall 3. The reservoir has a suspension 11 which is opposite the opening 12. The opening 12 is surrounded both by a valve 16 and also by a closure 13 that must be removed before extraction. The closure 13 is a screw cap. The opening 12 and the closure 13 are surrounded by a protective film 14 having a front side and a back side. The protective film also comprises a theoretical break point 15 with which the protective film 14 can be removed without problem. In this we must take extreme care that there is no contamination of the opening. It is true that it is possible to remove the closure with fingers that have not been sterilized, but nevertheless the internal area of the closure 13 and of the opening 12 should not be contaminated by this. Figure 2 shows a reservoir 100 in hanging form, the reservoir 100 hanging from the suspension 11 so that the opening 12 forms the lowest point. For drawing reasons, the lowest point of the deposit is not available on the bottom side, but in the lower right corner. It can also be seen that the protection film 14 has already been removed. However, the closure 13 is still on the opening 12. List of reference symbols 100 Tank 2 Front wall 3 Back wall 4 Seam welding of the tank walls Depot bottom 6 Support element 7 Welding seam of the support element 8 Front support member 9 Rear support member 10 Line 11 Suspension 12 Opening 13 Closing 14 Protective film 15 Theoretical breaking point 16 Valve

Claims (15)

1. CLAIMS Deposit to administer fluid substances comprising the following characteristics: (a) the deposit has flexible deposit walls; (b) the walls of the tank are in one piece or joined with one another; (c) the walls of the reservoir conform at least parts of a closed reservoir, reservoir having at least one opening; (d) the walls of the tank are joined with at least two two-dimensional supporting elements, which in the area of sustentation are separated from the walls of the tank; and which are eventually parts of the closed tank; (e) the opening comprises a closure and a connection, wherein (i) parts of the walls of the tank and / or of the support elements are made of a composite material comprising at least one laminate of synthetic material, and (ii) ) the other parts of the walls of the tank and / or of the supporting elements are made of a composite material comprising at least one laminate of synthetic material and an aluminum laminate, the laminates being firmly joined to one another.
2. Tank according to claim 1, in which the walls of the tank comprise a front wall and a back wall.
3. Tank according to claim 2, in which an aluminum laminate is provided in the back wall, the front wall being transparent.
4. Tank according to claim 3, in which the aluminum foil can be printed.
5. Tank according to claim 3 or 4, in which the front wall is made of polyester-polypropylene and the back wall of polyester-aluminum-polypropylene.
6. The tank according to one of the preceding claims, wherein a laminate of synthetic material is provided in the aluminum laminate on the side remote from the interior of the container.
7. Tank according to claim 6, in which the inner laminate facing the inside of the tank is made of polypropylene, the intermediate laminate is made of aluminum and the external laminate is made of transparent synthetic material.
8. 8. Tank according to claim 7, wherein the external laminate is of polyester or polyamide.
9. Tank according to one of the preceding claims, in which the walls of the tank are more flexible than the support elements.
10. 10. Tank according to one of the preceding claims, wherein the walls of the tank. They are resistant to dilation. Tank according to one of the preceding claims, in which the tank has at least one suspension opposite the opening. Tank according to one of the preceding claims, in which the closure is a screw cap with an original closure and / or a closure that can be opened by means of an adapter. Tank according to one of the preceding claims, in which the opening and the closing are surrounded by a protective film that is part of the walls of the tank or is attached to them. Tank according to one of the preceding claims, in which the tank can be thermally sterilized. The reservoir according to one of the preceding claims, wherein the fluid substance is a medicament or a diagnostic agent. The reservoir according to claim 16, wherein the diagnostic agent is a diagnostic agent that produces an image.