KR100561583B1 - Tank for Administering Flowable Substances - Google Patents

Abstract

The present invention comprises (a) flexible reservoir walls 2 and 3, (b) reservoir walls 2 and 3 are monolithic or interconnected, and (c) reservoir walls 2 and 3). Two or more horizontal standing elements 6, which form a sealed container with one or more openings 12, and (d) the reservoir walls 2 and 3 are separated from the standing portions of the reservoir walls 2 and 3. (E) the opening 12 has a stopper 13 and at least a portion of the reservoir walls 2 and 3 and / or the standing element 6 is (i) a plastic laminate. Or (ii) a composite material consisting of one or more plastic laminates and an aluminum laminate, wherein the laminates are connected to each other. The reservoir 100 is preferably provided for accumulating the contrast medium.

Reservoir, free-flowing material

Description

Tank for Administering Flowable Substances

The present invention relates to a reservoir for administering a free-flowing substance. In this case it is in particular a container from which the pharmaceutical substance, preferably the contrast medium, is removed. These are used as reservoirs for injection. This application claims priority in German patent application number DE 197 51 406, filed November 14,1997. In addition, in the United States, priority is claimed in US Application No. 60 / 067,342, filed December 2, 1997.

US Pat. No. 5,295,967, filed March 22, 1994, describes a reservoir suitable for administering infusion. Such reservoirs have flexible reservoir walls that engage each other at the edges. As a result, the reservoir wall forms a sealed container having two openings in the lower portion. One of these openings is connected to the injection device. An opening extending into the injection device is at the bottom of the reservoir. The reservoir can be suspended, whereby the front and rear walls of the reservoir couple to each other at the upper portion of the reservoir, and the reservoir has an opening at the joining site for suspending the entire reservoir. The reservoir also increases from top to bottom and has a scale attached to the reservoir.

In addition, reservoirs containing cleaning liquids are known from the cleaning industry. Such containers, unlike the above, have an opening at the top of the reservoir. Such containers have front and rear reservoir walls, front walls, and rear walls that are all flexible. They bind at edges with each other. The reservoir wall is surrounded by a standing element separated from the reservoir wall at the standing site. In addition, the standing elements combine with each other at the side and the upper portion to form a container. Only the bottom part, ie the bottom part, is in contact with the standing element with the container filled. At this site, the two standing elements are joined to each other through the reservoir wall, which in this case forms part of the bottom of the reservoir. Such containers are usually printed with colors and symbols. The disadvantage of this container is that the corresponding material is not compatible with pharmaceutical and diagnostic materials. It has also been found that there are problems with the printing process.

It is therefore an object of the present invention to provide a reservoir having a flexible reservoir wall and stable enough to withstand filled or partially empty conditions on relatively small surfaces. In addition, the reservoir is compatible with pharmaceutical and diagnostic agents and can be released without problems.

The object of the invention is achieved by a reservoir for administering a free flowing substance comprising the following features.

(a) has a flexible reservoir wall,

(b) the reservoir walls are single or connected together;

(c) the reservoir wall forms at least a portion of a sealed container having one or more openings,

(d) the reservoir wall is separated at a standing portion of the reservoir wall and is partially connected to at least two horizontal standing elements, optionally part of a sealed container,

(e) the opening has a stopper and a connection, preferably a double stopper,

(i) a portion of the standing element and / or reservoir wall consists of a material comprising at least one plastic laminate, optionally a composite material,

(ii) the standing elements and / or other portions of the reservoir walls are made of a composite material comprising at least one plastic laminate and an aluminum laminate, wherein the laminates are tightly connected to one another.

<Advantages>

The present invention has various advantages. Flexible reservoirs are highly desirable because they are easy to handle and the storage period and handling do not involve any problems. As long as the reservoir wall is sufficiently stable, no rupture of the vessel occurs. It is also advantageous to be able to use materials already widely supplied in the pharmaceutical industry. Infusion containers have been used for a long time, especially for blood transfusions. However, they are made of PVC material which is very controversial from an ecological point of view. The container and the reservoir according to the present invention are advantageous because they can be easily installed because they occupy a relatively small space at the installation site. On one and the same surface, significantly more reservoirs can be safely installed than can be installed in horizontal containers.

If at least part of the reservoir wall or standing element is made of a composite material with aluminum, printing of the corresponding reservoir can be carried out without problems. This is advantageous because the adhesive or coloring residue used for the label cannot penetrate into the interior of the reservoir. Such contamination is particularly problematic and occurs in particular when free-flowing materials, for example contrast media, are stored for long periods of time. The aluminum laminate successfully prevents the passage of the dye.

This also allows the reservoir to be printed permanently. Characters or symbols can be printed in addition to the printing by the plane pressure is advantageous. As a result, accurate matching of the outer surface of the reservoir with the reservoir contents is possible. This prevents the reservoirs from becoming indistinguishable from each other. Thus, the use of such reservoirs in the pharmaceutical and diagnostic field ensures a markedly increased reliability.

The aluminum laminate also protects the contents of the container from the surrounding environment. Release of the pharmaceutical formulation components and introduction of substances other than pharmaceutical formulations is largely impossible. In addition, there is no need to use additional protective packaging for the standing container for storing the pharmaceutical formulation. In case of repeated use (partial removal), the container contents are suitably protected by an aluminum composite.

Due to the transparency of the front wall of the reservoir, they can be visually inspected immediately after being filled by the pharmaceutical manufacturer and just before being used by a physician. It should also be emphasized that the opening of the reservoir is protected in multiple ways. The opening containing the screw-valve stopper is surrounded by a protective film which can be part of the reservoir wall or connected to the reservoir wall.

<Definition>

The reservoir is a container capable of containing free-flowing material. It is essential for the reservoir to be able to permanently seal such free-flowing material from the external environment. It is also important that the reservoir does not change the free-flowing material stored therein. Pharmaceutical formulations or diagnostic agents should not change chemically. In addition, the material must not penetrate the reservoir and must not be dissolved or mixed in the free-flowing material. In essence, the shape of the reservoir is not specific, but there are practical considerations such as storage and spillage. Thus, when the reservoir is emptied, it should be ensured that the free-flowing material can be completely discharged therefrom. The formation of cavities and angles at which free-flowing material cannot be discharged should be strictly excluded. In the case of a reservoir, it is important to be able to easily manufacture and to easily fill the free-flowing material.

The reservoir wall aims to separate the free-flowing material from the surrounding environment and to prevent the free-flowing material from being discharged. Conversely, it is also important to prevent material from the environment from penetrating into the free-flowing material. The reservoir wall is flexible when the operator exerts force. Only when the reservoir is installed on the standing element the standing element should be rigid in proportion to the static force of the reservoir. It is preferred that the reservoir wall is impermeable to both liquids and gases. It can also be observed that diffusion of gases occurs in almost all materials. It is essential to make the diffusion of gas small so that no damage occurs to the free-flowing material stored in the reservoir. In addition, the diffusion of the gas should not occur even if the free-flowing material in the reservoir is stored for an extended period of time, for example between one and two years. It is essential to have a reservoir wall that increases flexibility but cannot penetrate into free-flowing materials. Thus, for example, plastics contain softeners. These softeners should only allow negligible penetration into the free-flowing material.

Free-flowing substances are defined as all pharmaceutical and diagnostic substances. In this case it is a medicament comprising a pharmaceutically compatible adjuvant and vehicle. In addition, in addition to liquids, it is common for gases to still be found in the reservoir in the form of gas bubbles. In addition, free-flowing materials include liquid, solid and gaseous materials. Such mixtures are described in W. Schroeter et al., Chemie, Fakten und Gesetze (Chemistry, Facts and Laws), Leipzig 1987, 14th Edition, p. 24]. Also of interest are colloidal particle solutions such as suspensions, emulsions and liposomes.

The reservoir can be filled and discharged through the opening. In this case, separate filling and discharging openings can be fixed to the reservoir. The opening is preferably combined with the entire reservoir, the reservoir wall. The opening allows the injection device comprising the pump device to be easily connected to the reservoir. The opening should be large enough to allow a flow rate of 2 to 10 ml / sec through the opening. Such openings are preferably sterilized and protected from contamination by a cap lid. Only after this closure cap is removed can the injection device or pump be connected to the opening. Once the reservoir is open, extreme sterilization must be ensured since it must not be contaminated by hours to days.

The standing element aims to make the reservoir, preferably consisting of two reservoir walls coupled to each other, sufficiently stable so that the reservoir can be erectly erect when installed. The installation form is defined as the container standing up to one edge, so that the selected edge has the shortest length and lies in the opposite direction to the opening. In this case, the standing element does not impair the robustness of the reservoir but must have a hole that allows the entire reservoir to be suspended. This allows the reservoir to exit through the opening. This indicates that the opening is in the opposite direction as possible to the suspension. The standing element is preferably less flexible than the reservoir wall. They must be connected to the reservoir wall at least in small areas to have a suitable strength. Also in this case a durable and reliable transition between the reservoir wall and the standing element must be ensured. The standing element does not need to contact the entire length of the floor, but the proper stability of the reservoir should be ensured even with several contact points with the floor. The standing element may also be formed in a manner that replaces the reservoir wall as a whole. Only at the standing portion, ie at the bottom of the reservoir, there is no longer a direct connection to the standing element, but rather a reservoir wall which is connected via a bonding seam or an adhesive seam. Rather, the reservoir walls between the standing elements at the standing site are formed in a way that extends in a sealed manner between the standing elements. In this case, it is advantageous if the position where the surfaces formed by the reservoir walls are folded together behaves like wrinkles in the bottom portion of the reservoir which is upward towards the opening. When the reservoir is filled, these folds, which consist of the reservoir walls, are folded down to form the bottom of the reservoir. In essence, the standing element and the reservoir wall can be replaced in many places. In this case, however, it is essential that the function is still guaranteed. The reservoir wall has a function of preventing gas and liquid from penetrating. The standing element has the function of providing stability suitable for the reservoir and allows it to remain firmly in an upright position on the standing element. The extent to which the standing elements and the reservoir walls extend depends on the shape desired. However, it is essential that the standing elements are physically separable from each other in the lower part and face down. They border at the site of contact with the floor and surround the standing site.

Plastic laminates are described in Roempp-Chemie-Lexikon, publisher Juergen Falbe and Manfred Regitz, 9th Edition, Stuttgart 1990, p. 2398 ff] is a horizontal plastic described in detail. In addition, softeners and mixtures are necessarily plastics. The plastic should have flexible properties in the presence of the force exerted by the operator. In the case of static forces present in individually installed reservoirs, the standing element must be essentially rigid in proportion to the standing portion. At the same time, the plastic is completely sealed so that liquids and gases can penetrate the plastic stack only to a negligible extent. The plastic laminate can be transparent to varying degrees, and is preferably a completely transparent laminate. Preferably the plastic laminates are joined or glued so that the wall parts can be easily connected to one another at the edge of the reservoir.

At least one portion of the reservoir wall should be covered with an aluminum stack. This is an additional laminate contained in a plastic laminate. This has the advantage that as a result gas permeability is suppressed in the aluminum laminate part of the reservoir. The aluminum laminate also enables printing on the outward facing side from the free-flowing material. Since printing inks and solvents cannot penetrate the aluminum stack, there is no threat to the free-flowing material. In addition, the aluminum laminate allows the written material to be firmly coupled to the reservoir. In this case, what is written is no longer separated from the reservoir unless the reservoir itself is destroyed. This prevents the reservoir and the printout from mixing. Thus, aluminum laminates generally represent a print even when the bonded labels become unreadable or separated by climatic effects or wet conditions. Because aluminum is relatively hard, embossable, and letters and symbols are imprinted using pressure, the printout can be read even after losing color. In addition, aluminum has the advantage of generating a mirror effect at the site towards the free-flowing material. As a result, the observer can immediately and precisely inspect the contents of the reservoir if the opposite wall of the aluminum stack is made of a completely transparent material. Thus, any possible contaminant concentration or problem in the reservoir can be detected immediately.

<Other Embodiments>

The reservoir according to the invention is advantageous, wherein the reservoir wall comprises a front wall and a back wall. Such a reservoir is particularly simple in its manufacturing method. The two walls, namely the front wall and the back wall, are located next to each other and join together at the external site, thereby providing a recess in the opening. In addition to the bond, the walls can be glued. In the empty state, the folding container does not actually take up any space. However, the standing element allows the reservoir to be easily and firmly mounted on a flat surface in the charged state. Thus, the stability function and minimization of space requirements in the empty state are interrelated. Due to their flexibility, it is also possible to store filled reservoirs in a suitable way. In this specification, it is easy to stack various reservoirs on top of other reservoirs.

An aluminum laminate is provided on the back wall, in which case the front wall is preferably a transparent reservoir. The combination of printability and transparency of the opposite reservoir wall is most advantageous. This allows the reservoir to be clearly identified. When taking other commonly used precautionary criteria, there is no longer confusion concerning materials and reservoirs. In this case, the aluminum laminate is large enough to have suitable labels and other coding devices. Inside the aluminum stack towards the free-flowing material, a scale can be found indicating the volume also present 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. In this case they are the various layers connected to each other via bonding. In this case, they form a so-called composite film.

The reservoir according to the invention is preferred in which the aluminum is provided in a plastic laminate on the side from the inside of the reservoir to the outside. This protects the reservoir from rupture. Significantly greater tensile strength is imparted to the surface of the reservoir. Thin aluminum laminates having the above-mentioned advantages can be easily ruptured by the operation of the machine. In order to prevent this and to ensure the advantages mentioned above, an additional protective layer is provided on the reservoir. This reservoir also has a significant advantage during manufacture. Such outer surfaces can simply be bonded or glued without the use of high temperatures. In this case it is advantageous if the reservoir is provided with an outer plastic laminate at least at the sealing seam site.
More preferred is a reservoir in which the inner laminate (facing the interior of the container) consists of at least polypropylene, the intermediate laminate consists of aluminum and the outer laminate consists of transparent plastic. This three-layer structure exhibits a function. These correspond to plastics, aluminum and again plastics.

In most cases, the reservoir preferably comprises the outer laminate of polyester or polyamide. These are particularly suitable materials.

The reservoir according to the invention is advantageous in that the reservoir wall is more flexible than the standing element. This allows the reservoir to stand up regardless of how charged it is. However, two filling stages are preferred, on the one hand fully discharged and on the other hand fully charged. The reservoir is usually handled by the operator in these two steps. The partially charged state only occurs when a corresponding amount of material is removed from the reservoir, which occurs when the reservoir is generally emptied in the suspended form. In this case, the opening is invariably located at the lowest point of the reservoir.

A reservoir is advantageous in which the reservoir wall is resistant to expansion. This allows the reservoir not to be buckled against the reservoir wall even under high pressures, such as when the reservoir is stacked or when a strong short-term stress is applied. The latter is the desired shape with stability which ensures in a controlled manner that the reservoir wall is ruptured. In addition, the expansion resistance allows the reservoirs to be stacked and stored in specific reservoirs. This also avoids problems during charging.

More preferred is a reservoir according to the invention having at least one suspension facing the opening. This allows the contents of the reservoir to be completely emptied. Such suspensions can be arranged in a variety of ways and can only be holes or pitting located in the wide junction seam of the reservoir wall. However, it may also be an additional material connected in a flat manner to one or more reservoir walls. The suspension may also consist of a bayonet or adapter plug which is connected to a corresponding auxiliary suspension on the structure. In practice, it is useful to arrange the suspension and the opening diagonally to each other.

The reservoir according to the invention is advantageous in that the plug is an external tamper resistant plug and / or can be opened by an adapter. This allows on the one hand the removal to be carried out only once and on the other hand a sterile state can be ensured. The problem of sterile conditions is very important and solutions corresponding to this purpose are very advantageous.

In most cases a reservoir of the type according to the invention is preferred, wherein the opening comprising the closure is part of the reservoir wall or surrounded by a protective film connected to the reservoir wall. This allows the sterilized stopper to remain in sterilized form after the sterilization process performed after the reservoir is filled. This ensures optimally to avoid contamination of the connecting parts connected to the pump or the injection device.

It is advantageous for the reservoir to be heat-sterilized. This is a sterilization process performed both before and after the reservoir is charged.

After the reservoir has been partially bound, the impurities in the vessel can optionally be removed.

As the sterilization method, radiation sterilization or chemical sterilization is particularly suitable.

As the chemical sterilization method, in addition to hydrogen peroxide and ozone / vapor mixture, a treatment method using ethylene oxide, propane-3-oxide and diethyl dicarbonate is known.

In addition, sterilization using high energy radiation is possible. Such are known as gamma rays and X-rays.

Alternatively there is clean room preparation. As a result, it can omit the initial sterilization step.

The reservoir is optionally packaged in a manner that prevents microorganisms but sterilizes the gas in infiltrating films or aluminum. Sterilization is performed by chemical sterilization using heat and / or gamma rays or X-rays, neutron beams, or beta beams or mixed forms of the beams. Preference is given to treatment with hydrogen peroxide or an ozone / vapor mixture.

Subsequently, the reservoir is charged. Next, the filling opening is closed using a stopper.

In the next step, the reservoir is heat-sterilized using hot air or microwaves in an autoclave or sterilizer.

The gas may optionally create a support pressure in the sterilization chamber of the autoclave or sterilization chamber, such that the pressure on the outer surface of the reservoir is greater than, equal to or less than the pressure on the inner surface of the reservoir. The support pressure may be defined as the pressure corresponding to the limiting sum of the partial pressure of steam at the partial pressure of the sterilization chamber.

Packaging of sterile reservoirs in containers and sterilization of filled containers is particularly essential. This process can be carried out in the sterilization chamber. This step is particularly advantageous because it gives the attending physician a precautionary measure to provide an externally sterilized reservoir. This reduces the risk of contamination. Mechanically emptied reservoirs are often used in sterile operating rooms. Only sterile or uninfected materials are introduced into this room. Thus, the mechanically emptied reservoir must be completely externally sterilized.

Repositories in which the free-flowing substance is a medicament or a diagnostic agent are very preferred, and the diagnostic agent is most preferably an imaging agent. These are contrast mediums with the common names amidotrizoic acid, gadopentetic acid, gadobutrol, gadolinium EOB-DTPA, iopamidol, iopromide, iotrollan and itroxane.

The invention is illustrated in the drawings by way of examples.

1 shows an upright, reservoir in standing form.

2 shows a suspended form of reservoir suitable for discharging free-flowing material.

The reservoir 100 is shown in FIG. 1. In this case, the observer sees the transparent front wall 2. The front wall 2 only had transparent vertical lines, the rest of which could be coated with aluminum. By both releases it is possible to see the back wall 3 which is connected to the aluminum foil over the entire width and the entire length. The aluminum foil is located outside on the plastic film of the rear wall 3. The front wall 2 and the rear wall 3 are connected to each other via a joint seam 4. Bonding seams 4 vary in thickness. The bond seam at the longitudinal site is relatively large compared to the bond seam at the bottom site (5). Here, the rear and front walls are directly bonded to each other, where no aluminum is present. In releases not shown in the figure, the bottom may also be made of aluminum, thereby maximizing the surface coated with aluminum and at the same time allowing visual inspection through the front wall.

Standing element 6 is present in the region over the entire width of reservoir 100. In this case, the standing element 6 comprises a front standing element 8 and a rear standing element 9 all connected to each other via a joint seam 7. The front standing element 8 and the rear standing element 9 are connected at the site of the line 10 with the front wall 2 and the rear wall 3. In this case, the front standing element 8 and the front wall 2 are in direct contact, as is the rear standing element 9 and the rear wall 3. The front standing element 8 and the rear standing element 9 have a concave shaped line 10 in the form of a crescent moon. At this site, a part of the completely rectangular standing element is replaced by the front wall 2 or the rear wall 3.

The reservoir has a suspension 11 facing the opening 12. The opening 12 includes a valve 13 and a closure 13 to be removed before emptying the container. The stopper 13 is a screw-type stopper. The opening 12 and the closure 13 are surrounded by a protective film 14 having a front side and a rear side. In addition, the protective film has a predetermined breaking point 15 which can easily remove the protective film 14. In this case, special care should be taken not to contaminate the openings. It is possible to remove the stopper with an unsterilized hand, but the inner parts of the stopper 13 and the opening 12 should not be contaminated as such.

2 shows a reservoir 100 in a suspended form, in which the reservoir 100 is suspended on the suspension 11 and the opening 12 forms the lowest point. For the sake of illustration, the lowest point of the reservoir may be arranged in the lower corner, to the right rather than below the face.

It can also be seen that the protective film 14 has already been removed. However, the stopper 13 is still in the opening 12.

<Reference symbol list>

100 storage

2 front wall

3 rear wall

4 Bonding seam of the reservoir wall

5 bottom of reservoir

6 Standing Elements

7 Joint seam of standing elements

8 Front Standing Elements

9 Rear Standing Element

10 lines

11 suspension

12 opening

13 plug

14 protective film

15 predetermined burst point

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Claims (16)

(a) has flexible reservoir walls 2 and 3, (b) the reservoir walls 2 and 3 are monolithic or connected to each other, (c) reservoir walls 2 and 3 form at least a portion of a sealed container having one or more openings 12, (d) reservoir walls 2 and 3 are separated at standing portions of reservoir walls 2 and 3 and are at least partially connected to at least two horizontal standing elements 6 which are optionally part of a sealed container; , (e) the opening 12 has a stopper 13 and a connecting portion, (i) a portion of the standing element and / or reservoir wall is made of a composite material comprising one or more plastic laminates, (ii) the standing element and / or the other part of the reservoir wall consist of a composite material comprising at least one plastic laminate and an aluminum laminate, wherein the laminates are tightly connected to one another. Characterized by a reservoir (100) for free-flowing substance administration. 2. The reservoir according to claim 1, wherein the reservoir wall comprises a front wall (2) and a back wall (3). The reservoir according to claim 2, wherein the back wall (3) is provided in an aluminum laminate and the front wall (2) is transparent. The reservoir of claim 3, wherein the lettering can be printed on an aluminum laminate. The reservoir according to claim 3 or 4, wherein the front wall (2) consists of polyester-polypropylene and the rear wall (3) consists of polyester-aluminum-polypropylene. 5. The reservoir according to claim 1, wherein the aluminum is provided in a plastic laminate on the outward facing surface of the container. 7. A reservoir according to claim 6, wherein the inner laminate (facing the interior of the vessel) is made of polypropylene, the intermediate laminate is made of aluminum, and the outer laminate is made of transparent plastic. 8. The reservoir of claim 7, wherein the outer laminate consists of polyester or polyamide. 5. The reservoir according to claim 1, wherein the reservoir walls (2 and 3) are more flexible than the standing elements (6). 6. 5. The reservoir according to claim 1, wherein the reservoir walls (2 and 3) are intumescent resistant. 6. 5. The reservoir according to claim 1, wherein the reservoir has at least one suspension (11) facing the opening (12). 6. The stopper reservoir according to any one of the preceding claims, wherein the stopper (13) is a screwed stopper with an external tamper resistant stopper and / or which can be opened using an adapter. 5. The opening 12 comprising the closure 13 is part of the reservoir walls 2 and 3 or by means of a protective film 14 connected to the reservoir wall. Enclosed reservoir. 5. The reservoir according to claim 1, wherein the reservoir (100) can be heat-sterilized. 6. The reservoir according to any one of claims 1 to 4, wherein the free-flowing substance is a medicament or a diagnostic agent. The reservoir of claim 15, wherein the diagnostic agent is an imaging agent.

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