EP1761291A1

EP1761291A1 - Container for storing a product to be injected, and injection device

Info

Publication number: EP1761291A1
Application number: EP05766113A
Authority: EP
Inventors: Simone Gafner-Geiser; Rudolf Zihlmann; Hanspeter Heiniger
Original assignee: Disetronic Licensing AG
Current assignee: F Hoffmann La Roche AG; Roche Diabetes Care GmbH
Priority date: 2004-06-02
Filing date: 2005-05-27
Publication date: 2007-03-14
Also published as: WO2005118029A1; US20070123820A1; DE102004026805A1; JP2008501384A; CN1984691A; US7914500B2; CA2566826A1

Abstract

The invention relates to a container for storing a product to be injected, especially a therapeutic or diagnostic liquid. Said container comprises a container body (2) and a piston body (3) which is arranged in the container body in a sliding manner and can be displaced between a rear end position that determines a maximum filling of the container, and a front end position, in order to dispense the product. The inventive container is characterised in that the maximum opening ratio H/L of the container body is approximately 1.25 and preferably approximately 1.0, H corresponding to the maximum height of the container body and L corresponding to the maximum distance between the lateral walls of the container body.

Description

Container for storing a product to be injected and injection device

The present invention relates to a container for storing a product to be injected, in particular a therapeutic or diagnostic liquid, and an injection device with such a container.

More specifically, the present invention relates to a container comprising a container body and a piston body which is slidably disposed in the container body and is slidable for dispensing the product between a rear end position which defines a maximum filling of the container and a front end position. Containers of the aforementioned type are used in medical injection devices for storing a therapeutic or diagnostic liquid to be injected. By pushing the piston body towards a discharge opening of the container, the liquid is released into a hollow needle. The distribution can be metered by moving the piston body in a controlled manner.

Containers of the aforementioned type are always designed with a round, slender basic shape. A small footprint of the piston body has the disadvantage that comparatively high pressures have to be applied in order to advance the piston body to pour out the liquid. In containers of the aforementioned type, the metering of the liquid to be injected is accomplished with the aid of a metering mechanism which acts directly on the piston body, so that the dose to be injected is quasi provided in the container body itself. This requires a comparatively complex metering and shifting mechanism in order to provide the dose and to bring about a controlled advance of the piston body.

Injection devices for self-medication by the patient require comparatively small external dimensions for optimal transportability

Injection device. A metering and Sliding mechanism for the metered pouring of the liquid, which has a comparatively low energy requirement.

DE 196 52 708 AI discloses a plastic syringe body for medical purposes of the aforementioned type with a round and slim basic shape. An opening ratio, which is predetermined by the ratio of a maximum height of the container body to a maximum distance between side walls of the container body, is significantly greater than one. In order to be able to apply the comparatively high pressure required for advancing the piston body with little application of force, the base area of the piston is comparatively small, which limits the capacity of the container body and requires a large structural height of an injection device which receives the container body.

WO 00/02605 discloses a medical injection device for the administration of insulin with a container of the aforementioned type. A sufficient capacity of the container body requires a comparatively large overall height of the injection device, which is disadvantageous in particular for self-treatment by patients with the help of portable injection devices.

The object of the present invention is to develop a container for storing a product of the aforementioned type to be injected in such a way that it is suitable for use for a wide variety of types of metering and displacement mechanisms. Furthermore, a container is to be created in which a product can be distributed when a comparatively low pressure is applied to the piston body. Furthermore, according to the present invention, a container is to be created which can be exchanged even more safely and reliably, in particular for self-medication. Finally, according to the present invention, an injection device with a container according to the invention is also to be provided. This object is achieved by a container with the features according to claim 1 or 3 and by an injection device with the features according to claim 15. Further advantageous embodiments are the subject of the dependent subclaims.

A container for storing a product to be injected according to the present invention is characterized in that the container body has a comparatively small opening ratio, the opening ratio being defined by a quotient H / L, where H corresponds to a maximum height of the container body and L to a maximum Distance between side walls of the container body corresponds. Thus, the container body according to the present invention is characterized by a comparatively large base area. It is advantageous that, due to the large base area, only comparatively small differential pressures between the piston body and the discharge opening of the container body are required in order to cause the piston body to be displaced in relation to the product distribution.

The aforementioned opening ratio H / L of the container body is preferably at most about 1.25 and more preferably at most about 1.0. The opening ratio can also be significantly less than 1.0. It is advantageous that as long as the piston body is not yet inserted into the container body, a comparatively large opening is available, so that the entire inner surface or at least the inner peripheral surface of side walls of the container body can be coated practically unhindered, for example by vapor deposition, sputtering, plasma - Coating processes, sol-gel coating, immersion bath coating or the like.

Thus, according to the present invention, a coating can be applied to the surfaces relevant to the static and / or sliding friction between the container body and the piston body in order to reduce the static and / or sliding friction between these elements in a suitable manner. In this way, the minimum differential pressures required to move the piston body can be reduced even further. According to a further aspect of the present invention, which can also be addressed separately independently, a container according to the present invention is characterized in that with a sliding friction of 20N between the container body and the piston body, a maximum of the negative pressure which is necessary for displacing the piston body is about 0.2 bar. It is advantageous that the piston body can be moved with a comparatively low pressure to dispense the product. The container according to the invention is therefore also suitable for use in combination with micromembrane pumps which are distinguished by relatively low pressures but by small external dimensions and low energy consumption.

According to a further embodiment, a container according to the present invention is characterized in that with a static friction of 40N between the container body and the piston body, a negative pressure, which is necessary for displacing the piston body, is at most about 0.4 bar. It is advantageous that the piston body can be moved with a comparatively low pressure to dispense the product. The container according to the invention is therefore also suitable for use in combination with micromembrane pumps which are distinguished by relatively low pressures but by small external dimensions and low energy consumption.

According to a further embodiment of the present invention, the aforementioned coating can also be designed to reduce permeation and / or adsorption of gases and / or to reduce a frictional force between the container body and the piston body. As is well known, gases such as oxygen or water vapor diffusing through the walls of a container can affect the quality, durability and usability of a product stored in the container. By applying the aforementioned coating on the surfaces of the container responsible for the diffusion of gases, the quality, durability and usability of the stored product can also be guaranteed. Although the container body and / or the piston body can in principle be made from any suitable materials, at least the two aforementioned elements are preferably made from a plastic material, in particular from COC. It is advantageous that COC in particular has a relatively low gas permeability and at the same time has good biocompatibility. COC is also one of the few plastics that can be used for insulin. It is also advantageous that the elements mentioned can be manufactured by means of precise and at the same time inexpensive manufacturing processes, such as injection molding. The elements can be manufactured with such precision and under such hygienic manufacturing conditions that approvals for medical devices, as required in some countries, can be obtained without any problems.

The surfaces relevant for static and / or sliding friction or for the diffusion of gases are very particularly preferably coated using a low-temperature plasma process.

Because the piston body can be moved according to the invention by means of comparatively small differential pressures, the metering of the product to be dispensed can also be accomplished outside the container body, for example by means of an external pump, in particular a micromembrane pump. In this way, an energy-saving microdosing can be accomplished, which is particularly suitable for portable injection devices and / or for the continuous medication of patients. The low adhesive and / or sliding friction forces that can be achieved according to the invention are suitable, in particular for long-term medication, because of the resulting low energy requirement that is required for displacing the piston body.

Although the base area of the container body can in principle be of any design, in particular also circular or elliptical, the base area of a container body according to the invention is very particularly preferably polyhedral. A space provided in an injection device for receiving the container can thus be used even more efficiently, so that containers with a larger capacity can be provided with the same external dimensions of the injection device. The base area of the container body is very particularly preferably essentially rectangular.

In the case of such a rectangular base area, a bevel can be provided which shortens two side walls of the container body adjoining the bevel. The chamfer can be detected in a suitable manner, for example by optoelectronic or mechanical scanning, so that the shape and position of the container body can always be determined in a simple manner in all phases, in particular in the manufacture, storage, insertion into an injection device or in the disposal thereof can. Instead of such a bevel, another suitable marking range can of course also be provided on the container body, for example a notch, an optically readable marking, an optical reflector, a microwave reflector or the like.

According to a further preferred embodiment of the invention, the container is essentially of two parts and, in addition to the container body with the piston body accommodated therein, comprises a lid for covering the container body. It is advantageous that the cover prevents the plug from being moved unintentionally and damage to the container body or the piston body or the liquid stored in the container body can be reliably excluded. This construction also enables the container to be handled easily by patients, for example to replace the container in an injection device for self-medication. This is because the container can be treated in the manner of a cassette or a film without elements essential for the functionality of the container being accessible from the outside or the product stored in the container being contaminated or adulterated. The above-mentioned bevel or marking can be used to install the container in an injection device in a suitable orientation and orientation. Preferably, the lid and the container body can be connected to one another by means of latching means that interact with one another in each case. Suitable locking means are, for example, suitable locking means, hooking means or snap means. The latching means are very particularly preferably designed as projections on the container body or on the lid and as openings or cutouts correspondingly designed for this purpose at corresponding positions on the lid or the container body. The mechanical connection between the container body and the lid which is achieved in this way can in principle be detachable, but an essentially undetachable connection is preferred, so that patients cannot inadvertently damage important elements for the functionality of the container or falsify or impair the product stored in the container.

The aforementioned latching means are preferably each arranged substantially centrally on the side walls of the container body or of the lid, so that the force flows are even more symmetrical. The latching means are particularly preferably each formed essentially in the middle of a corresponding side wall of the container body or of the lid, very particularly preferably in an essentially point-symmetrical arrangement on the corresponding side wall. Of course, a plurality of latching means can also be formed on a side wall of the container body or the lid, with a symmetrical arrangement of the same being expediently preferred.

According to a further embodiment, the lid has a plurality of cutouts, the cutouts being formed at predetermined positions, preferably in a point-symmetrical arrangement, in order to code a concentration of the product stored in the container. The cutouts are expediently formed on the outer surface of the lid, so that they can be scanned optoelectronically or mechanically from the outside of the container. Of course, the recesses can also be designed as openings, for example as through bores. Of course, the shape of the recesses themselves can also be used for coding, for example at least one recess can be rectangular and / or at least one recess can be circular. The aforementioned point pattern and / or the configuration of the cutouts can also be used in a suitable manner for coding further important parameters of the container, container elements and / or the stored product, for example for coding the type of injection device for which the container can be used, the The type of product stored, the intended use of the product stored, the expiry date of the container and / or the product stored, etc.

Through the aforementioned through holes provided in the lid, a force can also be exerted by a mechanical displacement mechanism, for example a spring drive, by means of pins penetrating the through holes on the piston body for dispensing the product without the lid having to be removed from the container body.

For pouring out the product, the container preferably comprises a tubular outlet, which is preferably formed near the bottom of the container body, so that the product is essentially completely poured out in the front end position of the piston body. The tubular outlet is preferably closed off by a piercing membrane, so that the stored product can be kept hygienically and can be passed in a simple manner after piercing with a hollow needle or the like to a downstream injection needle or a downstream product dispensing and product dosing mechanism.

Latching means are preferably provided on an outer circumference of the tubular outlet in order to receive a closure for closing an outlet opening of the tubular outlet under the action of force. After filling the container body, the closure can be put on and locked more easily, for example, snapped. The aforementioned piercing membrane can be provided in the closure.

For filling with the product to be stored, the container body is preferably oriented such that the piercing membrane is at the top and the upright container body can be filled in the manner of conventional ampoules without bubbles.

So that the product can be substantially completely poured out, a trough-shaped recess can be provided in a bottom of the container body, which merges into an inlet of the tubular outlet. In the front end position of the piston body, in which the front end face of the piston body preferably abuts the bottom of the container body over a large area, even the smallest residues still remaining in the container body can be passed on to the discharge opening of the outlet.

According to a further aspect of the present invention, an injection device for the metered administration of a product to be injected, in particular a therapeutic or diagnostic liquid, is provided. The injection device according to the present invention is characterized by a container, which is designed in the manner described above, and by a displacement mechanism, which is designed to effect a distribution of the product by displacing the piston body in the container body.

While in ampoules, such as are usually used for the injection of therapeutic or diagnostic liquids, a negative pressure of, for example, about 1 bar is not sufficient to move the ampoule stopper only due to the prevailing negative pressure for the dispensing of liquid Piston body for moving the same can be greatly reduced. This enables energy-saving distribution of the product stored in the container body. Because the piston body can be moved according to the invention at low differential pressures, microdosing devices that can only generate relatively low differential pressures can also be used. According to the invention, a micromembrane pump is very particularly preferably used for displacing the piston body.

As a result of the low depression in the container body which is necessary for the displacement of the piston body, the drain on the outlet side of the container body will always be large enough to compensate for pressure losses in downstream sections of the injection device, in particular in hoses and hollow needles.

According to a further embodiment, the injection device is designed in such a way that a force is permanently applied to the piston body in its direction of advance, for example by a spring or tension spring or by a compressed air cushion that is under overpressure and acts on the piston body with force. This ensures even more energy-saving operation.

In the following, the invention will be described by way of example and with reference to the accompanying drawings, from which further features, advantages and objects to be achieved according to the present invention will result. Show it:

1 is a perspective view of a container body according to a first embodiment of the present invention;

FIG. 2 shows a side view of the container body according to FIG. 1;

3 shows a schematic plan view in partial section of the container body according to FIG. 2 along the line πi-DI;

FIG. 4 shows a perspective view of a piston body for receiving in the container body according to FIG. 1; FIG. 5 shows a perspective view of the container body according to FIG. 1 with the piston body according to FIG. 4 accommodated therein; FIG. 6 is a perspective view of a lid of the container body according to FIG. 1; FIG. 7 shows a perspective view of a container according to the present invention with the container body according to FIG. 1 and the lid according to FIG. 5; FIG. 8 shows a cross section through the container according to FIG. 7;

FIG. 9 is a perspective view of a modified container body according to FIG. 1;

10 is a perspective view of a container body according to a second embodiment of the present invention; and FIG. 11 shows a schematic illustration of the pressures to be applied in the container according to the present invention for displacing the piston body.

In the figures, identical reference symbols designate identical or essentially identically functioning elements or functional groups.

1 shows a perspective view of a container body according to a first embodiment of the present invention. The container body 2 has a substantially rectangular base area, the inner height of the container body 2 being substantially smaller than a maximum distance between the side walls of the container body 2. Thus, the opening ratio of the container body 2 is defined by the ratio of the maximum inner height of the container body 2 to a maximum distance between the side walls of the container body 2, significantly smaller than one.

The side walls are of stepped construction and each comprise a thick-walled section 6 and a thin-walled section 7. The difference in wall thickness between the thick-walled section 6 and the thin-walled section 7 is due to that Wall thickness of a lid to be placed on the container body 2 (FIG. 6) is coordinated such that the outer surfaces of the container formed in this way (FIG. 7) are essentially flush.

The side walls of the container body 2 have rounded corner sections 8, so that the inside of the container body 2 can be sealed in a simple manner with the aid of a plug-like piston body (FIG. 4). As shown in FIG. 1, the edges of the side walls are chamfered at the bottom of the container body 2, the helix angle being between approximately 5 to approximately 25 degrees.

A side wall 10 of the container body 2 is bevelled, so that the adjacent side walls of the container body 2 are shortened. As shown in FIG. 1, at least one essentially rectangular locking lug 11, which is chamfered on the upper side, is formed on each of the side walls, point-symmetrically to the thin-walled sections 7. The locking lug 11 interacts with openings 28 of the cover 4 (FIG. 6) which are designed accordingly and serve as locking means, so that the cover 4 can be snapped on in a simple manner. The lid snapped on in this way cannot be removed. According to a modified embodiment (not shown), the locking lugs 11 can also be designed to be flexible, for example resilient, so that the snap-on lid 4 can also be removed again by pushing the locking lugs 11 towards the side walls of the container body 2.

On the underside of the side wall of the container body 2 adjoining the chamfer 10, a tubular outlet 12 is formed, which has a discharge opening at its front end for pouring out the product stored in the container body 2. The tubular outlet 12 protrudes slightly beyond the associated side wall of the container body 2, so that a connection coupling or a hose for connection to a hollow needle or a downstream suction pump can be pushed on. For a secure connection to the hose or the connecting coupling, essentially rectangular locking lugs 13, which serve as latching means and are provided on the outer circumference of the tubular outlet 12. The locking lugs 13 are chamfered on one or both sides, so that the connecting coupling, not shown, or the hose can be pushed over in a simple manner and held captively.

FIG. 2 shows a side view of the container body according to FIG. 1. As shown in FIG. 2, the tubular outlet 12 is essentially flush with the underside of the container body 2 or an upper edge of the thick-walled section 6. As can be seen from FIG. 2, the heights of the thick-walled section 6 and the thin-walled section 7 are essentially identical. The bevel at the lower edge of the thick-walled section 6 corresponds approximately to half the height of the thick-walled section 6.

FIG. 3 shows a schematic plan view in partial section of the container body 2 according to FIG. 2 along the line m-HI. On the right edge of the container body 2, the tubular outlet 12 is formed with a central pouring opening 14, which is designed as a through-bore and which leads into the interior of the container body 2 via a recess 15, which is formed in the bottom of the container body 2. As shown in FIG. 3, the bottom of the container body 2 is surrounded on all sides by bevels 9, so that the interior of the container body can be sealed with a plug-like piston body (FIG. 4) in a simple manner.

FIG. 4 shows a perspective view of a piston body 3 for receiving in the container body 2 according to FIG. 1. The outer contour of the plug-like piston body 3 is adapted to the inner contour of the container body 2 and is essentially rectangular in shape, with a bevel 18 that two adjacent long sides of the piston body 3 shortened. The piston body 3 has chamfered corner sections 19. The wall thickness of the side walls of the piston body 3 is chosen in order to ensure sufficient inherent rigidity and sealing effect of the piston body 3.

As shown in FIG. 4, two circumferential sealing lips 20, which act as sealants, are formed on the outer circumferential surface of the piston body 3 and are formed from a comparatively soft plastic or rubber material in order to achieve a seal of the interior of the container body 2. The sealing lips 20 can be injection molded onto the outer peripheral surface of the piston body 3. The sealing lips 20 can also be designed as a rectangular plastic or rubber body with a circular, elliptical or rectangular profile, which is received in a peripheral recess formed on the outer peripheral surface of the piston body 3. Alternatively, the sealing means 20 can also be injection-molded onto the inner circumferential surface of the container body 2 or formed in the aforementioned manner, and the outer circumferential surface of the piston body 3 can be designed to be essentially smooth-walled. 4, the piston body 3 is essentially trough-shaped. Of course, the piston body 3 can also be designed as a flat plate body. 4, two sealing lips 20 lying vertically one above the other are formed. Any liquid passing through the sealing gap between the lower sealing lip 20 and the inner peripheral surface of the container body 2 can thus be retained in the gap between the lower and the upper sealing lip 20. Of course, one, three or more sealing lips 20 can alternatively be provided.

FIG. 5 shows a perspective view of the container body 2 according to FIG. 1 with the piston body according to FIG. 4 accommodated therein. A closure 5 is snapped onto the front end of the tubular outlet 12 and has a piercing membrane 33 for closing the discharge opening of the tubular one Has outlet 12. After piercing the piercing membrane 33 by means of a hollow needle or the like, product can be poured out of the container body 2 by advancing the piston body 3 towards the bottom of the container body 2. To fill the container body 2, the piston body 3 is brought into the rear end position shown in FIG. 5, which defines a maximum filling of the container body 2. The container body 2 is expediently oriented upright for filling, so that the tubular outlet 12 protrudes upward from the side walls of the container body 2 and the container body 2 rests on the side wall opposite the tubular outlet 12. For the orientation of the container body 2, the bevel 10 can be scanned by an optoelectronic or mechanical sensor device.

In this orientation, liquid can be poured into the space between the underside of the piston body 3 and the bottom of the container body 2 via the pouring opening 14 of the tubular outlet 12. For this purpose, the liquid can be filled in via a hollow needle, the outside diameter of which is smaller than the inside diameter of the pouring opening 14 of the tubular outlet 12. The discharge opening 14 is then closed by snapping the closure 5 with the piercing membrane 33.

FIG. 6 shows a perspective view of a cover 4 for the container body 2 according to FIG. 1. The basic shape of the cover 4 is essentially rectangular and is identical to that of the container body 2 according to FIG. 1. The cover 4 comprises one

Top 24 and projecting substantially perpendicularly from the top 24

Side walls 25. The transition area between the side walls 25 and

Top 24 is bevelled. One of the side walls 25 forms a bevel 26, so that the adjacent side walls 25 are shortened. As shown in FIG. 6, at least one recess 28 serving as a latching means is formed on the side walls 25 and the bevel 26, which with the correspondingly designed latching lugs 11 (FIG. 1) on the side walls of the

Container body 2 cooperate so that the lid 4 can be snapped onto the container body 2 and held there captively. As in FIG. 6 As can be seen, the cutouts 28 are formed essentially point-symmetrically on the rectilinearly projecting side walls 25 and the bevel 26.

On the upper side 24 of the cover 4, a plurality of cutouts 30, 31a-c and 32 designed as through bores are formed. The through hole 30 is formed centrally on the top 24. The through bores 31a-c are formed in a point-symmetrical arrangement in the respective corners of the cover 4. The through bore 32 closest to the bevel 26 is arranged closer to the central through bore 30 than the through bore 31b diametrically opposite thereto. Overall, the cutouts formed as through bores form a dot pattern which can be scanned optoelectronically or mechanically and can be used for coding. According to the present invention, the dot pattern is used to code the concentration of the liquid stored in the container. Of course, other parameters and properties of the stored liquid, the container, the container body and / or the piston body can also be encoded by the dot pattern, for example the type of the stored liquid, the manufacturer, the type of injection device to be used, the content of the container and the like ,

FIG. 7 shows a perspective view of a container 1 according to the present invention with the container body 2 according to FIG. 1 and the cover 4 according to FIG. 5. According to FIG. 7, the cover 4 is in the position shown in FIG. 5 shown rear end position of the piston body 3 snapped onto the container body 2, so that the locking lugs 11 engage in the correspondingly formed locking openings in the side walls and in the bevel 26 of the lid 4. In this configuration, the container 1 is stored and delivered. In this configuration, the piston body 3 is practically inaccessible from the outside of the container 1, so that unintentional product release can be avoided. Furthermore, important properties of the stored product, the container and the like are determined by the coding given by the dot pattern on the upper side 24 of the lid 4, which are scanned from the outside of the container 1 can be displayed in a clear manner. Furthermore, an installation position of the container 1 can be clearly indicated by the bevel 10. This means that the container can be replaced reliably and safely.

FIG. 8 shows a cross section through the container according to FIG. 7. As shown in FIG. 8, in the rear end position of the piston body 3 the top of the container body 2 protrudes slightly beyond the side walls of the piston body 3, so that when Filling the container body 2, a constant constant maximum amount can be specified. The maximum distance between the inner peripheral surfaces of the side walls of the container body 2 is L. The maximum internal height of the container body 2 is H, the chamfered edges at the bottom of the container body 2 having a height h. As can be seen directly from FIG. 8, an opening behavior of the container 1, which is defined by the ratio H / L, is very much less than one. Extensive investigations by the inventors have shown that from an opening ratio of approximately 1.25 a coating on the inner peripheral surfaces of the container body 2 is readily possible. According to the present invention, opening ratios of less than or equal to 1.0 are preferably used, more preferably the opening ratio is very much less than one.

The base area of the container body 2 and the properties of the inner circumferential surfaces of the container body 2 are selected in accordance with the present invention in such a way that with a sliding friction of 20N (ISO standard) between the container body 2 and the piston body 3, an under-pressure necessary for the displacement of the piston body 3 is a maximum of about 0.2 bar.

Furthermore, the base area of the container body 2 and the properties of the inner circumferential surfaces of the container body 2 are selected in accordance with the present invention such that with a static friction of 40N (ISO standard) between the container body 2 and the piston body 3, a negative pressure, which leads to the displacement of the piston body 3 is necessary, is a maximum of about 0.4 bar. FIG. 9 shows a perspective view of a modified container body according to FIG. 1. According to FIG. 9, the bevel 10 is not formed adjacent to the side wall of the container body 2 having the tubular outlet 12. The bevel 10 can be scanned optoelectronically or mechanically in order to indicate the orientation of the container body 2.

10 shows a perspective view of a container body according to a second embodiment of the present invention. According to FIG. 10, a trough-shaped recess or longitudinal groove 35 is formed in the bottom of the container body 2, which merges into the discharge opening of the tubular outlet 12, which is designed as a through-hole. If the piston body (not shown) lies practically completely against the bottom of the container body 2 in its front end position, even the smallest remaining amounts of the product stored in the container body 2 are reliably passed on to the discharge opening.

11 shows a schematic, semi-logarithmic representation of the pressures to be applied in the container according to the present invention for displacing the piston body, as well as other relevant properties of the container. According to the order given in the legend of FIG. 11 from top to bottom, the data values denoted by rhombuses denote the total base area of the container according to the invention on the basis of a square cross section of the container; - The data values marked with dark squares indicate the maximum stroke of the piston body required to dispense a total of 1.5 ml; - The data values marked with bright triangles indicate the maximum stroke of the piston body required to dispense a total of 3.0 ml; the data values denoted by x represent the under-pressure required to displace the piston body on the basis of a sliding friction of 20N between the piston body and the container body; - The data values marked with an asterisk indicate the vacuum required to displace the piston body on the basis of a static friction of 40N between the piston body and the container body; - The data values denoted by dark circles are the total height H of the container body required to achieve a constant capacity of the container body; and the data values denoted by the plus sign represent the respective opening ratio a = H / L, wherein according to the schematic view at the bottom right in FIG. 11 H corresponds to a maximum height of the container body and L corresponds to a maximum distance between side walls of the container body.

The aforementioned container body and its most important elements, in particular the piston body and the sealant, are preferably made from a plastic material by injection molding. COC has proven to be particularly useful as a material that is one of the few plastics that is suitable for storing insulin.

The container can be inserted into an injection device in a predetermined orientation without the lid having to be removed. The bevel of the container or an optical or mechanical marking provided on the housing of the container can be used to specify the orientation.

A micromembrane pump is preferably used for advancing the piston body, as is disclosed, for example, in DE 4402 119 AI or DE 197 37 173 AI, the contents of which are hereby expressly included by reference in this application, in particular as regards the structure and functioning of the Concerning micro diaphragm pump.

As is known, relatively low differential pressures in the range up to about 1.5 bar can be used in a particularly energy-saving manner with micro-membrane pumps of the aforementioned type be generated. Micromembrane pumps of the aforementioned type are further characterized by a comparatively small space requirement, so that in combination with the container according to the invention, which also requires a comparatively small footprint, relatively small injection devices can be implemented, which can be transported in a simple manner or carried by the patient and that have low energy requirements. Such an injection device is preferably used for the long-term administration of microdoses of insulin for self-medication of diabetes patients.

reference numeral

Container, container body, piston body, lid, closure, thick-walled section, thin-walled section, corner section, lower edge of the container body, bevel, locking means, tubular outlet, locking device, outlet opening, recess, bottom of the container body, long side of the piston body, beveling of the piston body, corner section, sealant, bottom of the piston body, upper bevel, of the locking device, gap between the container body and piston body, top of the cover, side wall of the cover Bevel of the cover corner section of the cover locking means edge of the cover 30 central recess bar

31a-c further recesses

32 recess

33 piercing membrane

34 locking means of the closure 5

35 trough-shaped depression

H Inside height of the container body

L maximum distance between side walls of the container body

Claims

Expectations

1. A container for storing a product to be injected, in particular a therapeutic or diagnostic liquid, comprising a container body (2) and a piston body (3) which is slidably arranged in the container body (2) and for dispensing the product between a rear end position, the defines a maximum filling of the container (1), and a front end position is displaceable, characterized in that an opening ratio H / L of the container body (2) is at most about 1.25 and more preferably at most about 1.0, where H is a maximum height corresponds to the container body (2) and L corresponds to a maximum distance between the side walls of the container body.

2. Container according to claim 1, in which the container body (2) is designed so that with a sliding friction of 20N between the container body (2) and the piston body (3), a negative pressure, which is necessary for displacing the piston body, at most about 0, Is 2 bar, and / or in which the container body (2) is designed so that with a static friction of 40N between the container body (2) and the piston body (3), a negative pressure, which is necessary for displacing the piston body (3), is maximal is about 0.4 bar.

3. Container for storing a product to be injected, in particular a therapeutic or diagnostic liquid, comprising a container body (2) and a piston body (3) which is slidably arranged in the container body (2) and for dispensing the product between a rear end position, the defines a maximum filling of the container (1), and a front end position is displaceable, characterized in that the container body (2) is designed so that at a sliding friction of 20 N between the container body (2) and the piston body (3), a negative pressure which is necessary for displacing the piston body is a maximum of about 0.2 bar.

4. Container according to the preceding speech, characterized in that with a static friction of 40 N between the container body (2) and the piston body (3), a negative pressure which is necessary for displacing the piston body (3), a maximum of about 0.4 bar is.

5. Container according to one of the preceding claims, wherein at least the container body (2) is made of a plastic, in particular COC, wherein an inner surface of the container body or the container body and the piston body is provided with a coating in order to permit permeation and or adsorption to reduce gases and / or to reduce a frictional force between the container body (2) and the piston body (3).

6. Container according to one of the preceding claims, wherein a base of the container body is rectangular.

7. A container according to the preceding claim, wherein a bevel (10) is provided which shortens the two side walls of the container body (2).

8. Container according to one of the preceding claims, further comprising a cover (4) for covering the container body, the cover being connectable to the container body by means of latching means (11, 28) which interact with one another in each case.

9. Container according to the preceding claim, wherein the latching means (11, 28) are each arranged substantially centrally on the side walls of the container body (2) or the lid (4).

A container according to one of the two preceding claims, wherein the lid (4) has a number of recesses (30, 31), the recesses being formed at predetermined positions, preferably in a point-symmetrical arrangement, in order to increase a concentration of the product stored in the container encode.

11. A container according to any preceding claim, further comprising a tubular outlet (12) for spilling the product.

12. A container according to the preceding claim, wherein the tubular outlet is closed by a piercing membrane (33).

13. Container according to one of the two preceding claims, wherein locking means (13) are provided on an outer circumference of the tubular outlet (12) in order to receive a closure (5) for closing an outlet opening (14) of the tubular outlet.

14. Container according to one of claims 11 to 13, in which in a bottom of the container body (2) a trough-shaped recess (35) is provided which merges into an inlet of the tubular outlet (12).

15. Injection device for the metered administration of a product to be injected, in particular a therapeutic or diagnostic liquid, characterized by a container according to one of the preceding claims and a displacement mechanism, which is designed to by a displacement of the piston body (3) in the container body (2) Distribution of the product.

16. Injection device according to the preceding speech, wherein the displacement mechanism comprises a micromembrane pump.

7. Injection device according to one of the two preceding claims, wherein the piston body (3) is permanently subjected to a force in its feed direction.