Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers

Definitions

• the invention relates to a reservoir for the administration of flowable substances.
• these are bags in which pharmaceutical substances, preferably contrast agents, are filled. They serve as a reservoir for infusions.
• US Pat. No. 5,295,967 which was issued on March 22, 1994, describes a reservoir which is suitable for administering infusion liquids.
• a reservoir has flexible reservoir walls which are welded to one another in the edge regions.
• the reservoir walls form a closed container which has two openings in the lower region.
• One of these openings is connected to the infusion set.
• the opening that merges into the infusion set is at the bottom of the reservoir.
• the reservoir can be suspended, the front and rear walls of the reservoir being welded to one another in the upper region of the reservoir and having a perforation in the welding region, which enables the entire reservoir to be suspended.
• the reservoir has a scale that extends from top to bottom and that is printed on the reservoir.
• Reservoirs containing liquid detergent are also known from the detergent industry. Bags of this type have an opening which, in contrast to before, is located in the upper region of the reservoir. Such bags have front and rear reservoir walls, a front wall and a rear wall, all of which are flexible. They are welded together in the edge areas. The reservoir walls are surrounded by stand elements which are separated from the reservoir walls in the stand area. The stand elements are also welded to one another in the lateral and upper regions, so that they form a bag. Only in the bottom area, that is to say in the lower area, do the stand elements have no contact when the bag is filled. In this In the area, the two stand elements are connected to one another via the reservoir walls, which in this case form base parts of the reservoir. Such bags are usually printed with colors and symbols. The disadvantage of these bags is that the corresponding materials are not compatible with pharmaceutical and diagnostic substances. Printing processes also prove to be problematic.
• the reservoir having sufficient stability to be able to stand securely in a relatively small area when filled or partially de-filled. Furthermore, the reservoir for pharmaceuticals and diagnostics should be compatible and should be easy to empty.
• a reservoir for the administration of flowable substances comprising the following features:
• the reservoir has flexible reservoir walls, (b) the reservoir walls are in one piece or connected to one another;
• the reservoir walls form at least parts of a closed container, which container has at least one opening;
• the reservoir walls are partially connected to at least two flat stand elements which are separated from the reservoir walls in the stand area; and which may be part of the closed container,
• the opening has a closure and a connector, preferably a double closure, wherein
• parts of the reservoir walls and / or stand elements are made of a material that comprises at least one plastic laminate, optionally a composite material, and (ii) the other parts of the reservoir walls and / or stand elements are made of a composite material that at least one plastic laminate and an aluminum laminate includes, the laminates are firmly connected.
• the invention has several advantages. Flexible reservoirs are very desirable, they are easy to handle, their storage and handling are easy. If the reservoir walls are sufficiently stable, the reservoirs cannot be torn open. It is also advantageous to be able to use materials that are already widely used in the pharmaceutical industry. Infusion bags have long been used in blood transfusions. However, they consist of the material PVC, which is very controversial from an ecological point of view. It is advantageous that the bags and reservoirs according to the invention can be set up without any problems. Because they take up little space when set up. Significantly more reservoirs can be safely stored on one and the same surface than would be possible with flat bags. If at least parts of the reservoir walls or stand elements consist of composite material with aluminum, printing on the corresponding reservoirs is possible without problems.
• An aluminum laminate successfully prevents the dyes from penetrating. This also ensures that the reservoirs can be printed in an irreparable manner. It is advantageous that in addition to the planar printing, the letters or characters can also be pressed in. This enables a clear assignment of the reservoir content and the reservoir outer surface. This prevents the reservoirs from being mixed up. This results in a significantly higher level of security in using such reservoirs in the field of medicines and in the diagnostic field.
• the aluminum laminate also protects the contents of the bag from the environment.
• a reservoir is a vessel in which flowable substances can be received. It is essential for the reservoir that it can permanently shield the flowable substances from the outside world. It is also important that the reservoir avoid a change in the enclosed flowable substances. For example, pharmaceuticals or diagnostic substances must not change chemically. It should also be avoided that substances penetrate into the reservoir and either dissolve in the flowable substance or mix with it. In principle, the shape of the reservoir is not fixed, but there are practical reasons such as storage and discharge. This ensures during emptying that the entire flowable substance can escape from the reservoir. Avoid the formation of cavities and angles from which the flowable substance cannot escape. It should also be noted with the reservoir that the same can be easily produced and can easily be filled with the flowable substance.
• the function of the reservoir walls is to separate the flowable substance from the environment and to prevent the flowable substance from escaping. Conversely, it must also be avoided that substances from the environment can penetrate into the flowable substance.
• the reservoir walls are flexible in the effort of the operating personnel. Only when the reservoir is placed on the stand elements, the stand elements have to be rigid with respect to the static forces of the reservoir.
• the reservoir walls are desirably impermeable to both liquids and gases. It can also be seen that the diffusion of gases takes place through almost every material. It is essential that the diffusion of gases is so low that there is no impairment of the flowable substance inside the reservoir. This should not occur even if the flowable substance in the reservoir over a longer period, such as Example one or two years. It is essential that the reservoir walls have substances which increase flexibility, but which cannot penetrate into the flowable substance. For example, plastics also contain plasticizers. These plasticizers are said to be able to penetrate the flowable substance in an insignificant manner and amount.
• Flowable substances are understood to mean all pharmaceutical and diagnostic substances. These are drugs, including their pharmaceutically acceptable excipients and carriers. It is often the case that in addition to a liquid there are also gases in the form of a gas bubble in the reservoirs. In addition to liquids, flowable substances also include solid and gaseous substances. Such mixtures are shown in W. Schröter et al .: Chemistry, Facts and Laws, Leipzig 1987, 14th edition, p. 24. Suspensions, emulsions and micelle solutions such as liposomes are also of interest.
• the reservoir can be filled and emptied.
• a filling opening and a separate discharge opening can be attached to the reservoir.
• the openings are preferably welded to the entire reservoir, in particular to the reservoir walls.
• the openings are intended to enable the infusion set, including a pump device, to be connected to the reservoir without problems.
• the openings must be large enough to allow flow rates of 2 - 10 ml / sec through the openings.
• Such openings are preferably sterilized and are protected from contamination by sealing caps. Only after removing these caps is it possible to connect the infusion set or the pump connection to the opening. Extreme sterility must be observed, since it must be expected that once opened reservoirs must remain free of contamination for several hours, even up to several days.
• the stand elements have the task of giving the reservoir, which preferably consists of two reservoir walls welded together, such stability that this reservoir can also stand securely in the erected form.
• the shape set up is defined by the fact that the bag comes to rest on an edge, preferably the edge which has the smallest length and which is opposite the opening is selected.
• the base elements expediently have a perforation which does not endanger the tightness of the reservoir, but which nevertheless make it possible to suspend the entire reservoir. This makes it possible to allow the reservoir to flow out through the opening. This shows that as far as possible the opening of the suspension device is opposite.
• the stand elements are preferably less flexible than the reservoir walls. They have to be connected to the reservoir walls at least in small areas in order to have a corresponding strength.
• the stand element does not need to touch the floor over the entire length, but it should be ensured that the reservoir is sufficiently stable even with a few contact points with the floor.
• the stand elements can also be constructed such that they practically replace the reservoir walls as a whole. Only in the stand area, that is to say in the lower area of the reservoir, do reservoir walls then appear, which are no longer connected directly to the stand element, but rather via a weld seam or an adhesive seam. Rather, the reservoir walls between the stand elements in the stand area are constructed in such a way that they extend sealingly between the stand elements.
• the surface formed by the reservoir walls in the lower region of the reservoir behaves like a fold which, when folded, points upwards towards the opening.
• this fold which consists of the reservoir walls, folds down and then forms the bottom of the reservoir.
• the stand elements and reservoir walls can be exchanged in many areas. It is essential that the functions are guaranteed.
• the function of the reservoir walls is to prevent gases and liquids from penetrating.
• the stand elements have the function of giving the reservoir sufficient stability so that it can stand securely on the stand elements in the upright state.
• the extent to which stand elements and reservoir walls extend can be varied from shape to shape. However, it is essential that the stand elements in the lower area, pointing towards the floor, are spatially separable. They should limit and include a footprint in the area of contact with the floor.
• Plastic laminates are flat plastics, which are described in detail in Römpp-Chemie-Lexikon, edited by Jürgen Falbe and Manfred Regitz, 9th edition, Stuttgart 1990, p. 2398 ff.
• the plastics include inevitably also plasticizers and additives.
• the plastics must have the property of being flexible in the forces that occur with the operating personnel.
• the stand element In the case of static forces which are present in the case of an individually installed reservoir, the stand element should be essentially rigid in relation to the stand area.
• the plastics should absolutely have a sealing function, so that liquid and gases can only penetrate this plastic laminate in a non-noteworthy manner.
• the plastic laminates can be transparent in different ways, completely transparent laminates are preferred.
• the plastic laminates should preferably be weldable or glueable, so that wall parts can be connected to one another without problems in the edge regions of the reservoirs.
• At least part of the reservoir walls should be covered with an aluminum laminate.
• This is an additional laminate located on the plastic laminate. This has the advantage that the gas permeability in this part of the reservoir is prevented.
• the aluminum laminate enables the aluminum laminate to be printed on the side facing away from the flowable substance. Printer ink and solvents cannot penetrate the aluminum laminate, so that there is no risk to the flowable substance. This also guarantees that the lettering is firmly connected to the reservoir afterwards. The label can no longer be detached from the reservoir without destroying the reservoir itself. This ensures that the reservoirs and the imprints cannot be mixed up.
• the aluminum laminates show imprints that would otherwise have made the pasted labels illegible or would have caused them to become detached in the event of weather or drenching.
• Aluminum Since aluminum is relatively rigid and embossable, the letters and characters can also be stamped during printing so that the print can still be read even after the color has been lost. Aluminum also has the advantage that a mirror effect occurs in the region which faces the flowable substance. As a result, the viewer can immediately critically examine the contents of the reservoir if the wall opposite the aluminum laminate is made of completely transparent material. The consistency, any contamination or problems in the reservoir can thus be discovered immediately.
• Other embodiments are relatively rigid and embossable, the letters and characters can also be stamped during printing so that the print can still be read even after the color has been lost.
• Aluminum also has the advantage that a mirror effect occurs in the region which faces the flowable substance. As a result, the viewer can immediately critically examine the contents of the reservoir if the wall opposite the aluminum laminate is made of completely transparent material. The consistency, any contamination or problems in the reservoir can thus be discovered immediately.
• a reservoir according to the invention is advantageous in which the reservoir walls comprise a front wall and a rear wall.
• This is a very simple method, particularly in terms of manufacture.
• Two walls, namely the front and the rear wall, are placed on top of one another and welded to one another in the outer regions, a recess being provided for the opening.
• the walls can also be glued.
• Such folded bags hardly take up any space when empty. Because of the standing elements, however, such a reservoir is well able to stand securely on a flat surface when filled. Stability functions and a minimization of the space requirement in the emptied state are thus linked to one another. Due to the flexibility, a sensible storage of the filled reservoirs is still possible. Different reservoirs can easily be stacked on top of each other.
• a reservoir in which the rear wall is provided with an aluminum laminate is preferred, the front wall being transparent.
• the combination of the printability and the transparency of the opposite reservoir wall is the most advantageous. It ensures that the reservoir is clearly labeled. It is no longer possible to mix up the substances and the reservoirs if the usual precautionary measures are taken.
• the aluminum laminate can be large enough to carry a corresponding label and also other coding systems. On the inside of the aluminum laminate, pointing towards the flowable substance, there may be a scale on which it can be seen which volumes are still in the reservoir.
• Another very advantageous embodiment consists of a reservoir in which the front wall is made of polyester propylene and the back is made of polyester aluminum polypropylene. These are different layers that are connected to each other by welding. So-called composite foils are formed.
• Reservoirs according to the invention are preferred in which the aluminum is provided with a plastic laminate on the side which points away from the interior of the container. This provides protection against tearing.
• the reservoir gets a significantly higher tear resistance on the surface.
• Thin aluminum laminates which have the advantages mentioned above, can easily be torn by mechanical action.
• the reservoirs are provided with the additional protective layer made of plastic. Furthermore, this reservoir has a significant advantage during manufacture. Such external surfaces can be easily welded or glued without the need for high temperatures. It is advantageous if the reservoirs are provided with the outer plastic laminate at least in the areas of the sealed seams.
• the inner laminate facing the container interior
• the middle laminate made of aluminum and the outer laminate made of transparent plastic are more preferred.
• This three-layer structure is functional. It corresponds to plastic, aluminum and plastic again.
• reservoirs in which the outer laminate is made of polyester or polyamide. These are particularly suitable materials.
• Reservoirs according to the invention are advantageous in which the reservoir walls are more flexible than the stand elements. This ensures that the reservoirs can be in an upright form regardless of the state of filling.
• two filling stages are preferred; on the one hand the completely empty state and on the other hand the completely filled reservoir. In these two states, the reservoirs are usually handled by the operator.
• the partially present filling states only occur when the corresponding amount of flowable substance is removed from the reservoirs, which occurs when the reservoirs are usually emptied in a hanging form. The opening always lies at the bottom of the reservoir.
• Reservoirs in which the reservoir walls are resistant to expansion are advantageous. In this way, it is successfully avoided that even at higher pressures, such as can occur during stacking or short-term loads, it is ensured that the reservoirs cannot tear with respect to the reservoir walls. This is a desired form of security that guarantees that the reservoir walls are prevented from tearing open in a controlled manner. Furthermore, the resistance to stretching ensures that the reservoirs can also be stacked in certain deposits. This also avoids problems during filling.
• Reservoirs according to the invention are more preferred in which the reservoirs have at least one suspension which lies opposite the opening. This ensures that the contents of a reservoir can be completely removed.
• a suspension can be designed differently, it can only be an eye or a perforation which is located in the wide weld seam of the reservoir walls. However, it can also be an additional material which is connected to at least one of the reservoir walls.
• the suspension can also consist of a bayonet or adapter lock, which can be connected to a corresponding complementary suspension on a frame. In practice it makes sense to arrange the suspension and the opening diagonally opposite each other.
• a reservoir according to the invention is advantageous in which the closure is a screw closure with tamper-evident closure and / or a closure that can be opened by an adapter. This ensures that, on the one hand, the removal can only take place once and, on the other hand, sterility can be guaranteed. The problem of sterility is to be taken very seriously and appropriate solutions for this are very advantageous.
• a reservoir of the type according to the invention the opening including the closure being surrounded by a protective film which is part of the reservoir walls or is connected to them. This ensures that after a sterilization process, which takes place after filling, a sterile closure also remains in this sterile form. This ensures in the best possible way that contamination of the connection piece, which is connected to the pump or to the infusion set, is avoided.
• a reservoir in which the reservoir can be thermally sterilized is advantageous. This should be a sterilization that takes place both before filling and after filling. After the reservoir has been partially welded together, it may be possible to clean the reservoir of foreign objects.
• sterilization processes radiation sterilization or chemical sterilization processes. Treatment with ethylene oxide, propan-3-olide and diethyl dicarbonate, hydrogen peroxide and an ozone / steam mixture are known as chemical sterilization processes.
• Sterilization with high-energy radiation is also possible.
• Gamma rays and X-rays are known here. Manufacturing in a clean room is an alternative. This means that these first sterilization steps can be dispensed with.
• the reservoirs are sterile packed in bacteria-proof 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 rays or beta rays or a mixture of the aforementioned rays. Treatment with hydrogen peroxide or ozone / steam mixture is preferred.
• the reservoir is then filled.
• the filling opening is then closed by the closure.
• the reservoir is placed in the autoclave or sterilizer
• Hot air or thermally sterilized using a microwave Hot air or thermally sterilized using a microwave.
• the support pressure is to be defined as the pressure which corresponds to the sum of the partial pressures in the sterilization room minus the partial pressure of the steam.
• the packaging of the sterilized reservoirs in a container and the sterilization of the filled container are particularly important. This can be done in a sterile room. This step is particularly advantageous because it provides security to offer the treating physician a reservoir that is also sterile on the outside. This can reduce the risk of contamination.
• the mechanically emptied reservoirs are often used in sterile operating rooms. Only sterile rooms are allowed in these rooms or disinfected materials. Thus, a mechanically emptied reservoir must also be absolutely sterile on the outside.
• Reservoirs in which the flowable substance is a medicament or diagnostic agent are very preferred; a reservoir in which the diagnostic agent is an imaging diagnostic agent is most preferred.
• These are the following contrast agents with the generic names: amidotrizoic acid, gadopentetic acid, gadobutrol, gadolinium EOB-DTPA, lopamidol, lopromid, lotrolan and lotroxinic acid.
• the invention is shown by way of example in the drawing. 1 represents a reservoir, which is shown in an upright, standing form.
• FIG. 2 shows a reservoir in a hanging form, the reservoir being suitable for emptying the pourable substance.
• a reservoir 100 can be seen in FIG. 1.
• the viewer looks at the front wall 2, which is transparent.
• the front wall 2 could also only have a transparent longitudinal strip, the remaining surface being coated with aluminum.
• Both variants allow a view of the rear wall 3, which is connected with an aluminum foil over the entire width and over the length A.
• the aluminum foil is located on the outside of the plastic film of the rear wall 3.
• the front wall 2 and the rear wall 3 are connected to one another via a weld 4.
• This weld 4 has different thicknesses.
• the weld seam is relatively large compared to the weld seam in the bottom area 5.
• the rear wall and front wall meet directly, there is no aluminum here.
• the base can also be made of aluminum, whereby the surface coated with aluminum is maximized and at the same time the visual control through the front wall is ensured.
• the standing element 6 is located in the area C over the entire width of the reservoir 100.
• the stand element 6 comprises a front stand element 8 and a rear stand element 9, both of which are connected to one another via a weld seam 7.
• the front stand element 8 and the rear stand element 9 are connected to the front wall 2 and the rear wall 3 in the area of the line 10. In this case, the front stand element 8 and the front wall 2 come into direct contact and also the rear stand element 9 and the rear wall 3.
• the front stand element 8 and the rear stand element 9 have a crescent-shaped recess 10. In this area, the part of the idealized rectangular stand element is replaced by either the front wall 2 or the rear wall 3.
• the reservoir has a suspension 11, which is opposite the opening 12.
• the opening 12 is both with a valve 16 and with a Closure 13 surrounded, which must be removed before removal.
• the closure 13 is a screw closure.
• the opening 12 and the closure 13 is surrounded by a protective film 14 which has a front and a back.
• the protective film also has a predetermined breaking point 15 with which the protective film 14 can be removed without problems. Care must be taken to ensure that the opening is not contaminated. Although it is possible to remove the closure with non-sterile fingers, the inside of the closure 13 and the opening 12 must not be contaminated.
• FIG. 2 shows a reservoir 100 in a hanging form, the reservoir 100 being suspended from the suspension 11, so that the opening 12 forms the lowest point.
• the deepest point of the reservoir should not be located at the bottom of the page, but in the lower right corner.

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• Health & Medical Sciences (AREA)
• Hematology (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Packages (AREA)
• Hydroponics (AREA)
• Table Devices Or Equipment (AREA)
• Bag Frames (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• External Artificial Organs (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
• Tubes (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Manufacturing Of Micro-Capsules (AREA)
• Bidet-Like Cleaning Device And Other Flush Toilet Accessories (AREA)
• Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
• Water Treatment By Sorption (AREA)
• Devices For Use In Laboratory Experiments (AREA)

Priority Applications (16)

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Cited By (3)

Citations (4)

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• 1998
  • 1998-11-16 HU HU0100081A patent/HUP0100081A3/hu unknown
  • 1998-11-16 CA CA002309840A patent/CA2309840C/en not_active Expired - Fee Related
  • 1998-11-16 ES ES98956915T patent/ES2193584T3/es not_active Expired - Lifetime
  • 1998-11-16 CZ CZ20001762A patent/CZ296418B6/cs not_active IP Right Cessation
  • 1998-11-16 PT PT98956915T patent/PT1028689E/pt unknown
  • 1998-11-16 TR TR2000/01292T patent/TR200001292T2/xx unknown
  • 1998-11-16 AT AT98956915T patent/ATE239439T1/de not_active IP Right Cessation
  • 1998-11-16 JP JP2000520743A patent/JP2001522708A/ja active Pending
  • 1998-11-16 AU AU13381/99A patent/AU741541B2/en not_active Ceased
  • 1998-11-16 IL IL13609798A patent/IL136097A0/xx not_active IP Right Cessation
  • 1998-11-16 EP EP98956915A patent/EP1028689B1/de not_active Expired - Lifetime
  • 1998-11-16 SK SK669-2000A patent/SK285462B6/sk not_active IP Right Cessation
  • 1998-11-16 DK DK98956915T patent/DK1028689T3/da active
  • 1998-11-16 KR KR1020007005210A patent/KR100561583B1/ko not_active IP Right Cessation
  • 1998-11-16 WO PCT/EP1998/007292 patent/WO1999025308A1/de active IP Right Grant
  • 1998-11-16 BR BR9814193-7A patent/BR9814193A/pt not_active IP Right Cessation
  • 1998-11-16 PL PL98340377A patent/PL189428B1/pl not_active IP Right Cessation
• 2000
  • 2000-04-26 IS IS5472A patent/IS2249B/is unknown
  • 2000-05-12 NO NO20002485A patent/NO320698B1/no not_active IP Right Cessation

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