DE102008057822B4 - Device for storage and dermal administration of a substance - Google Patents

Abstract

Device for storing and dermal administration of a substance, having at least one dermal interface (8) and a flexible bag (1, 1 ', 1' '), the at least one dermal interface (8) being attached to the bag (1, 1', 1 '') or in the bag (1, 1 ', 1' ') is inserted or molded, the bag (1, 1', 1 '') comprises at least a first chamber (10) to the substance or a Solvent, and the bag (1, 1 ', 1' ') comprises at least one second chamber (11) for fluidically connecting the first chamber (10) to the dermal interface (8), characterized in that the bag ( 1, 1 ', 1 ") comprises at least one releasable clamp and / or at least one seam (9) which can be separated at least in one seam section, wherein the clamp and / or the separable seam seal the at least one first (10) of the at least one second seam Chamber (11) separates.

Description

Background of the invention

The invention relates to a device for the storage and dermal administration of a substance, wherein the device comprises at least one dermal interface. In addition, the invention relates to a method for producing a device for storage and dermal administration of a substance.

From the European patent EP 1 301 236 B1 (German translation published as DE 601 06 261 T2 A delivery device for dermal delivery of a substance to a patient is known which comprises a housing, a flat element with a plurality of microneedles which can be inserted into the housing and a prefilled bubble-shaped reservoir which can also be inserted into the housing and which is separate therefrom. The delivery device should be gently pressed against the skin until the microneedles have penetrated into the outermost skin layer. Furthermore, pressure should be applied to the bladder-shaped reservoir so strongly that it is punctured by a cannula provided in the delivery device, so that the contents of the reservoir can reach the microneedles in order to be able to be supplied to the skin. It may be disadvantageous in the feed device that particles which can at least partially block the microneedles form during the piercing of the reservoir. In addition, the feeder can be cumbersome to handle.

The European patent EP 1 490 146 B1 (German translation published as DE 603 05 901 T2 ) discloses an apparatus for intradermally administering a substance to a patient comprising a housing and a cartridge insertable into the housing. The cartridge has an upper and a lower wall and a rigid side wall extending perpendicular thereto. The upper wall, together with a rigid bottom wall and parts of the side wall, form a reservoir for the substance to be administered. The top wall of the cartridge is formed of a flexible material so that it can be pushed inwardly to dispense the contents of the reservoir via a fluid channel. The fluid channel has an outlet opening which is closed by a sealing element. To open this sealing element is located in the side wall of the device, a piercing device. Once the sealing element has been pierced, the contents of the reservoir can reach the bottom wall via the fluid channel and leave the device via skin penetration elements arranged in this wall. On the device may be disadvantageous that the piercing device requires space in the device. Furthermore, the cartridge may be expensive to produce because of its complicated structure.

From the international publication WO 2004/032990 A1 For example, a plaster-like, portable and standalone infusion device for administering a drug to a patient is known. In this case, the drug reservoir is formed by one or two flexible films and a rigid wall. A septum is provided in the rigid wall which must be punctured to allow the contents of the reservoir to be forwarded to one or more microneedles for administration. A similar infusion device is also known from the international publication WO 2005/018705 A1 known. Here, a valve is arranged in the rigid wall, which is to ensure a tight closure of the reservoir for storage of the drug. It may be disadvantageous in the known infusion devices that the piercing device or the valve requires space and the complicated construction of the devices leads to a high production outlay.

The international publication WO 99/24086 A1 discloses a multichamber bag for intravenous administration of a substance mixture to a patient. For this purpose, the chambers are separated by seams, which can be separated by exerting pressure on the outside of the bag. In this way, the chamber contents can be sterile mixed together before leaving the bag via a port for intravenous administration. A similar multi-chamber bag is also from the European patent application EP 1 621 178 A1 and from the German patent DE 100 41 295 B4 known. The known multi-chamber bag can be used for infusion therapy, what they are attached to the bedside on a stand above the position of the patient. An infusion line can be used to connect to an intravenous access. In this case, pressure can be built up on the principle of the gravimetric pump due to the difference in height between bag and patient. On the known multi-chamber infusion bags can be disadvantageous that they are unsuitable for wearing on the body.

From the US Pat. No. 4,693,711 For example, there is known a device for transcutaneous administration of a medicament having two chambers separated by a rupturable membrane for keeping two substances separate from one another. For use, the membrane may be ruptured by deforming the housing.

The US patent publication US 2003/0208167 A1 discloses a device for transporting a substance into or through the skin, the two separated by a rupturable barrier Reservoirs has. By an external force to the barrier, the z. As a thin film, a polymer or a laminate film can be torn.

The problem underlying the invention

The invention has for its object to provide an improved device for storage and dermal administration of a substance. It is also an object of the invention to provide an improved method of manufacturing a device for storage and dermal administration of a substance.

Inventive solution

The object is achieved by a device for storage and dermal administration of a substance comprising at least one dermal interface and a flexible bag, wherein the at least one dermal interface attached to the bag or inserted or molded into the bag. The bag thereby comprises at least a first chamber for holding the substance or a solvent and at least one second chamber for fluidically connecting the first chamber to the dermal interface. Finally, the bag comprises at least one releasable clip or at least one seam which can be split into at least one seam section, wherein the clip and / or the separable seam separates the at least first from the at least one second chamber.

A flexible bag according to the present invention is a hollow and easily deformable body. The flexibility of the bag can be created by the material properties of the bag material. The flexibility of the bag can also be realized by a structure of the bag or by the combination of structure and material properties.

A dermal interface in the sense of the present invention is an agent that can deliver the substance to the skin of a patient. In principle, both a supply to the skin, d. H. topically, z. B. via a membrane, a supply to the skin, z. B. intradermally or subcutaneously, and a supply through the skin, z. As intravenous, intraarterial or intramuscular, in question.

By having the dermal interface attached directly to the bag or inserted or molded into the bag, fluidic contact can be made between the bag interior and the dermal interface. In particular, it is advantageously possible to dispense with a connection line between the bag and the injection needle acting there as the dermal interface in the case of the infusion bags according to the prior art. The expulsion of the substance from the device is possible by pressure on the bag from the outside. This can advantageously be dispensed with a gravimetric pump.

It is an achievable advantage of the invention that the device according to the invention can be manufactured using a packaging machine according to the prior art. In particular, it is achievable to use the apparatus using a bag making machine, e.g. B. a tubular bag machine to produce.

The device according to the invention is particularly suitable for administering different substances to a patient, in particular a human, both for therapeutic and for cosmetic purposes. A substance in the sense of the present invention may be both a single substance and a mixture of substances or a solution and / or suspension of one or more substances in a solvent and / or suspending agent. The substance is preferably liquid, particularly preferably aqueous.

The invention can be advantageously used for pharmaceutical substances, ie. H. Use substances with biological activity, which are transmitted via a body membrane, eg. As mucous membranes, especially the skin, the patient can be supplied. Suitable substances with biological activity are z. Medicines, nutrients, nutritional supplements and adjuvants. Examples include: antibiotics, antiviral agents, analgesics, anesthetics, anorexics, antiarthritics, antidepressants, antihistamines, anti-inflammatory agents, antineoplastic agents, vaccines, vitamins and biologics. Other substances which can be dermally administered to a patient with the invention include natural, synthetic or recombinant proteins, peptides, DNA, RNA and fragments of the foregoing.

It is also possible to use the device for tattooing, for example for cosmetic purposes or for marking animals. For this purpose, the agent may be a dye, which is introduced by the dermal interface on the skin or in the appropriate skin layer. With the invention, in particular, a long-lasting or permanent make-up can be generated, inter alia, to cover skin defects, impurities and the like. It is also possible with the invention to supply the skin with cosmetic substances such as skin brighteners, skin tanning agents and moisturizing agents.

Preferred embodiments of the invention

Advantageous embodiments or developments, used individually or in combination with each other are the subject of the dependent claims. In this case, the reference signs in the claims are not intended to be limiting, but are merely intended to facilitate reading of the claims by reference to certain embodiments.

In a preferred embodiment of the device according to the invention, the dermal interface is attached to the outside of the bag. In a preferred method of the invention, the dermal interface is attached to an exterior of the bag.

The at least one dermal interface is preferably permanently connected to the bag, e.g. B. by gluing or by welding. With this embodiment of the invention can be achieved that the device can be produced easier and cheaper. The handling can be simplified. In one embodiment of the invention, the bag and the dermal interface are integrally formed, such as by injection molding, deep drawing or by perforating the bag surface. In this case, the bag or at least the part of the bag on which the dermal interface is integrally formed, and the dermal interface of the same material. However, it may also be advantageous in certain applications that the bag and integrally formed dermal interface are at least partially formed of different materials, such as by 2-component injection molding or by coextrusion, another thermoforming process, or other suitable manufacturing process.

In a preferred embodiment of the invention, at least one dermales interface is attached to a bag surface, inserted into a bag surface of the bag or molded, z. B. by being welded to the bag surface, welded into the bag surface, glued or glued or formed integrally therewith. In a device with several dermal interfaces, these can be inserted or molded in the same or in different bag surfaces. The purpose of the dermal interface is to bring a liquid solution into contact with the skin. The bag may be smaller, equal to or larger than the dermal interface.

In one embodiment of the invention, the bag has at least one bag seam. The bag seam can be formed by welding, gluing, or another suitable method by which the bag surfaces can be joined together to close the bag. Preferably, at least one dermales interface is inserted into the bag seam, preferably welded or glued. In a device with multiple dermal interfaces, these may be inserted into the same or different bag seams. One or more dermal interfaces may also be attached to or inserted into one or more bag surfaces, or inserted or molded in, and one or more further interfaces may be inserted or formed in one or more bag seams.

The dermal interface preferably has a connection port, preferably a hollow connection port, for establishing a fluidic contact with the interior of the bag, with which it is inserted into the bag or molded onto the bag. The port is not a long flexible hose, z. As an infusion line, thought. Preferably, the connection port is not longer than 30 cm. Particularly preferably, the connection port is not longer than 10 cm. Most preferably, the port is as short as possible, d. H. shorter than 3 cm, more preferably shorter than 1 cm. In particular, the connection port is not a detachable connection as in the case of an infusion line, but rather a fixed connection. In a preferred embodiment of the invention, the connection port is a short tube section. For example, the dermal interface with this tube section may be inserted into a bag suture to fluidly connect it to the bag interior. In another preferred embodiment of the invention, the connection port is a flange surface surrounding an opening in a surface of the dermal interface. The opening may be disposed opposite a corresponding opening in a bag surface to fluidly connect the dermal interface with the bag interior. It is also conceivable that needles of the dermal interface pierce a bag surface so as to provide fluid communication between the dermal interface and bag interior.

A preferred bag is a foil bag which is formed from one or more flexible films as packaging material. As a packaging material in particular flexible films in question. These may be films which consist of one or more composite films, ie of several layers. Preference is given to PVC-free films of transparent polymers, which can have very good barrier properties, which can form permanent welds and peel seams and which can be sterilized. Slides of this type are z. B. described in DE 195 15 254 A1 and EP 0 228 819 B1 the entire content of which is incorporated herein by reference. Also conceivable are films which consist of a composite of one or more inorganic layers (preferably aluminum) with one or more polymeric layers. Elastic or stretchable films or flexible films with elastic and / or elastic properties suitable for the application are also conceivable. The packaging material layers from which the bag surfaces are formed need not necessarily be flat, but can, z. B. be bulged by means of a thermoforming process. This can be achieved particularly advantageous that the bag volume is increased. The volume of the bag is preferably not greater than 200 ml (milliliters). It is more preferably less than 10 ml, most preferably less than 1 ml.

The preferred bag may be formed from two substantially superposed bag surfaces. The bag may be provided with a seam or seams running around its entire edge, for example in the case of a 4-side bag. Alternatively, only a part of the bag edge may be provided with a seam, such as when two or more bag surfaces are formed of integrally continuous packaging material layers, such as a 3-side bag or a tubular bag.

The bag according to the invention comprises at least one first chamber in order to hold the substance or a solvent, preferably a liquid, particularly preferably an aqueous solvent. In one embodiment of the invention, only one solvent for the substance is present in the first chamber and the substance itself is present in a further chamber of the bag or in or on the dermal interface. In this way, it can advantageously be achieved that the solvent, when it flows through the further chamber or the dermal interface, can dissolve the substance present there, in order then to administer it in dissolved form through the dermal interface.

The bag according to the invention comprises at least one second chamber which fluidly connects the first chamber to the dermal interface. The substance or solvent may then advantageously pass from the first chamber through the second chamber to the dermal interface. The second chamber is preferably kept as small as possible, more preferably smaller than the first chamber, to facilitate emptying the bag as completely as possible.

Preferably, the bag includes at least one seam to separate the first from the second chamber. The seam is preferably separable at least in a seam section. The separable portion of the suture is preferably a so-called peel suture, also referred to as a "peelable seal". Although the separable seam can basically have any shape, it is preferably straight. With this embodiment of the invention is advantageously achieved that can be separated by exerting a pressure from the outside of the first chamber of the separable portion of the seam, so that the contents of the first chamber can pass through the split seam portion in the second chamber. The second chamber is preferably fluidly connected to the dermal interface. This advantageously achieves that by separating the separable seam section, the first chamber can be fluid-connected to the dermal interface by means of the second chamber. In particular, it can be achieved that the bag is leakproof prior to severing in order to store the contents of the first chamber securely and sterile in the device, and only when necessary is the connection to the dermal interface made so that the contents of the bag are released from the device through the dermal interface can be.

In an alternative embodiment of the invention, instead of the seam, the first and second chambers are separated by an externally mounted releasable clip, the clip pressing the opposite bag surfaces together so that the first chamber is completely closed. It may also be advantageous, in addition to the separable seam, and preferably in the region of this seam, to attach the releasable clamp in order to protect the separable seam from accidental separation, in particular during transport and storage. It can also be provided several first chambers, each with a separable seam or z. B. another aforementioned or described below closure are completed. One or more channels, preferably formed by welds, may lead to the dermal interface behind the closures. There, the channels can either lead separately or together to Hautdurchdringungselementen.

In a preferred embodiment of the invention, a detachable cover of the dermal interface is provided instead of and / or in addition to the at least one separable seam and / or the at least one clip. In this way, it is advantageously achievable to close the device tightly, in particular in order to prevent the substance from prematurely leaving the device. In addition, it can be achieved that the dermal interface and the bag contents are kept sterile. The cover is preferably formed by a piece of film, for. From any of the materials listed above as preferred materials for the bag. You can z. B. with a detachable seam, particularly preferably with a peel seam, be attached to the dermal interface or a part of the bag surface in the region of the interface releasably. Preferably, a pull tab is provided on the cover to which a user can engage the cover to peel it off.

The cover may also be cup-shaped and slipped over the dermal interface. In this case, preferably an inner surface of the Cover, z. As made of rubber, on an outer surface of the dermal interface close to and is frictionally held on it. It is also conceivable that the cover is attached to a housing part in which the bag is built with dermalem interface, z. Example, a part of the housing of a dosing system, or that it is part of a package in which the bag, particularly preferably together with a dosing system, is present. The dermal interface may additionally or alternatively also include a septum with a puncture device or a valve to tightly close the device prior to use.

Between the cover and the dermal interface may be a chamber which is particularly preferably filled, z. B. with a gas, one or more solids, eg. As a powder, a liquid or a combination thereof. The filling can particularly advantageously protect the dermal interface from damage, eg. When the dermal interface has needles as skin penetrating elements which could easily break off. The filling may also serve the purpose of keeping the space between the chamber closure and the dermal interface as free as possible of unwanted gas, gases, one or more solids, eg. As a powder, a liquid or a combination thereof.

In a preferred embodiment of the invention, the dermal interface has at least one skin-facing opening. Preferably, the at least one opening of the dermal interface extends into the skin or through the skin.

The dermal interface preferably delivers the substance to a defined target area of the skin. The target surface can be located in or under the skin, in particular. By a corresponding pressure, the substance, which is preferably in the form of a solution, can pass through this surface in order to be administered particularly preferably intradermally, subcutaneously or intramuscularly. The preferred transdermal interface is equipped for this purpose with one or more, preferably hollow, skin penetrating elements. The skin penetration elements may, for. B. made of stainless steel, plastic or silicon. In a preferred embodiment of the invention, the dermal interface comprises at least one injection needle, preferably a plurality of injection needles. The injection needle or hypodermic needles are preferably microneedles. The preferred needles have a length between 40 μm (microns) and 2 mm (millimeters), more preferably between 160 μm and 1.5 mm. The strength of the preferred needles is between 80 μm and 480 μm, particularly preferably between 160 μm and 320 μm. Several skin penetrating elements, preferably up to a hundred skin penetrating elements, more preferably up to ten skin penetrating elements, are preferably in the form of an array, e.g. B. in the form of a microneedle array arranged. These are z. B. arranged parallel to each other in a flat support member of the transdermal interface. Preferably, the support member and the skin permeation members, more preferably the entire transdermal interface, most preferably the pouch and transdermal interface, are of the same material, e.g. As plastic, formed, particularly preferably in one piece, z. B. by injection molding or deep drawing.

In a preferred embodiment of the invention, the dermal interface is at least one means for delivering the substance to a defined area of the skin. This can be realized via the at least one body-facing opening. Preferably, these are at least one means for supplying the substance to the skin surface and the bag made of the same material, particularly preferably in one piece, for. B. by perforating, in particular micro perforating, at least part of a bag surface. In addition, these openings can with z. B. a permeable at least for the substance membrane and / or a / m Compress, cotton compress, gauze compress, gel matrix, nonwoven fabric, other textile material, or a sponge.

In order to facilitate the permeation or penetration of the substance into or through the skin, the substance or the solvent may contain a penetration-enhancing additive, also referred to as a "penetration enhancer". The device may also include physical means to facilitate permeation or penetration, in particular electrical, thermal or mechanical means known to those skilled in the art.

In order to be able to fill the first chamber with the substance or the solvent, the device is preferably equipped with at least one filling port which can connect the chamber or the chambers to the environment. With the filling port is advantageously accessible to be able to fill the bag with a sterile filling machine. Particularly preferably, the bag is made unfilled and sterile or manufactured and then sterilized. Then it is filled with a sterile filling machine. In a particularly preferred embodiment of the invention, the reservoir or the chambers is closed after filling with a further weld and then cut off the Befüllport.

When filling a bag without peel, the dermal interface may have a cover be provided to prevent during the filling process, a flow of the substance or the solvent. Alternatively, emptying via the dermal interface can also be prevented, for example, by a low filling pressure or additional counterpressure, which is large enough to prevent the liquid from escaping through the dermal interface. The dermal interface can also be used to vent the bag during the filling process.

Alternatively, the device can also without Befüllport, z. B. before the complete welding of the bag in a tubular bag packaging machine, are filled, as long as the sterility is guaranteed. For example, the longitudinal seam and the first transverse seam can first be formed for this purpose and then the filling material can be introduced through a filling device which runs through a forming shoulder which is needed to define the shape of the bag. Subsequently, the bag can be closed with the second transverse seam.

The device of the invention is preferably insertable into a metering system to be controlled by the metering system or to administer the substance from the bag via the dermal interface in a controlled manner. The preferred metering system may apply pressure to the bag, preferably to the first chamber of the bag, to deliver the substance to the dermal interface and subsequently to the patient. In particular, the separable seam can be separated by the pressure exerted by the metering system before the substance is dispensed. The dermal interface and / or the bag of the device according to the invention may be equipped with connecting elements to connect the device to parts of the housing of the metering system.

In a preferred embodiment, the device comprises at least one holding device in order to fix the bag and / or the dermal interface on the skin. With this embodiment of the invention is advantageously achieved that the bag with dermal interface, preferably inserted into the dosing system, over several minutes to hours or even days can be worn on the body, z. For about 6 to 8 hours during the night. Suitable holding device are z. B. Langzugbinden, short-stretch bandages, gauze bandages, linen bandages, textile hoses or elastic bandages. Thus, the bag with dermalem interface, if necessary with dosing z. B. attached to an arm. Alternatively, adhesive layers, in particular comprising self-adhesive or adhesive materials (tape, plaster, spray adhesive) can be used to realize sufficient adhesion to the body. A third alternative is microneedles, which extend into the skin and possibly provide additional barbs for fixation. The at least one skin-facing opening of the dermal interface is preferably partially or completely enclosed by an adhesive layer. The adhesive layer of the at least one skin-facing opening of the dermal interface is preferably located on the dermal interface or bag or on the housing in which the dermal interface is incorporated.

Of course, it is also conceivable to use the invention entirely or at least in part without the metering system. Thus, for example, the patient or the medical staff by manually pressing z. B. with your finger on the bag, preferably the first chamber, the severable severable severing seam and / or expel the substance.

Brief description of the figures

The invention will be explained in more detail below with reference to schematic drawings of exemplary embodiments with further details.

They show schematically:

1 an embodiment of the device according to the invention in the form of a 4-side bag with welded to a bag surface dermal interface, namely a) from below, b) in a longitudinal sectional view through the plane of the peel seam and c) from above;

2 an embodiment of the device according to the invention in the form of a 3-side bag with welded to a bag surface dermal interface, namely a) from below, b) in a longitudinal sectional view through the plane of the peel seam and c) from above;

3 the device of 1 inserted into a metering system in cross-sectional view perpendicular to the plane of the device;

4 an embodiment of the device according to the invention in the form of a 4-side bag with welded in a weld dermal interface from above;

5 an embodiment of the dermal interface in the form of a microneedle array with a cover and a cover chamber formed between the cover and interface;

6 the execution of the dermal interface of 5 a cap-like cover placed on the interface and a cover chamber formed between the cover and the interface; and

7 a method for filling the device according to the invention with the dissolved substance or the solvent.

Detailed description of the invention based on embodiments

In 1 is a flat 4-side bag 1 shown, whose two bag surfaces 2 . 3 be formed by two superimposed same or different layers of packaging material on the four sides of the rectangular bag by welds 4 . 5 . 6 . 7 welded together. At the bottom, ie in the use of the skin facing bag surface 5 is a dermal interface 8th attached as a microneedle array by welding or gluing. Through a peel seam 9 the bag is in two chambers 10 . 11 separated. The first chamber 10 forms a reservoir in which the substance or a solvent for the substance is kept. The second chamber 11 provides a channel for fluidic connection of the first chamber 10 with the dermal interface 8th This channel may also contain the substance. To reduce the volume of the channel is the second chamber 11 narrowed, by a widening of the welds 5 . 7 in the area of the second chamber 11 , The first chamber 10 runs in the area of the peel seam 9 funnel-shaped, resulting in an increasing width of the weld 5 . 7 achieved in this area.

So that the bag contents to the dermal interface 8th can be dispensed, is the bag bottom 2 at the point where the dermal interface 8th is attached, with an opening 12 Mistake. The opening 12 can z. B. by punching or cutting, z. As laser cutting, are formed. The dermal interface 8th has in its bag-facing surface as a connection port on a corresponding opening (not shown), through which the bag contents in the interface 8th can occur.

In the 2 shown device differs from the in 1 shown by the fact that it is here at the bag to a 3-side bag 1' in which the short sides of the rectangular bag with welds 4 . 6 are welded and a third longitudinal seam 13 on one of the sides of the bag, here the top of the bag 3 are attached to the bag 1' to close. This seam 13 may also be performed on one side of the bag (not shown). In a production of a film tube (not shown), this longitudinal seam would also 13 absence.

3 shows a cross section through the device of 1 inserted in a dosing system 14 for the controlled or controlled delivery of the bag contents. The dosing system 14 includes a pressure-exerting top 15 and a rigid counter-plate 16 , between which the first chamber 10 of the two-chambered bag 1 is inserted. Because of that, the top part 15 of the dosing system 14 to the first chamber 10 Pressure exerts and the chamber 10 due to the counter plate 16 can not escape, becomes the first chamber 10 pressed together. The pressure increase causes the peel seam 9 opens. About the second chamber 11 , which acts as a fluidic channel, the substance can with solvent from chamber 10 or the solvent (in chamber 10 ) dissolved substance (in chamber 11 ), to the dermal interface 8th reach. The dermal interface 8th is designed as a microneedle array, with a flat carrier 17 and several needles (an example with 18 designated), whose channels the carrier 17 penetrate. Here is the carrier 17 in the area of at least one opening 12 with the bag surface 2 connected so that the liquid bag contents through the opening 12 and the channels of the needles can be transported into the skin.

An embodiment of the invention wherein the dermal interface is in a suture of the bag 1'' is welded in, is in 4 shown. Again, this is the dermal interface 8th a microneedle array that has a short hollow neck 19 equipped by a seam 6 into the bag. The neck 19 is in the dermal interface 8th facing bag seam 6 liquid-tight and sterile welded.

5 shows an embodiment of one with a foil cover 20 sterile closed dermal interface 8th in the form of a microneedle array. The cover is peeled by a seam 21 with the part of the interface surrounding the microneedles 8th connected. The cover 20 can by the user with the help of an unillustrated tab from the dermal interface 8th be solved to expose it. An alternative form of cover is in picture 6 shown. Here is a cup-shaped cover 22 frictionally over an edge 23 pushed the dermal interface and is held there strong. Between cover 22 and dermal interface 8th is a sealing surface 24 educated. The cover chamber 24a passing through a space between the cover 22 and the dermal interface 8th is formed, is filled with a foam plastic, around the delicate microneedles 18 to protect.

Finally shows 7 a method for filling the device according to the invention with the dissolved substance or the solvent. This is a filling port 25 provided, the one the bag 1 outward closing seam 26 in the area of the first chamber 10 penetrates. Through the port 25 can the chamber 10 from a sterile filling machine (not shown). The bag 1 will be like in 7a ), made sterile or manufactured and then sterilized. It is then filled in a sterile filling machine. After filling, the first chamber 10 with another weld 4 , as in 7b ), near the filling port 25 be closed. The filling port 25 can, as in 7c ) to be cut off after the filling process.

The features disclosed in the foregoing description, the claims and the drawings may be of importance both individually and in any combination for the realization of the invention in its various forms.

Claims (16)

Device for storing and dermal administration of a substance, having at least one dermal interface ( 8th ) and a flexible bag ( 1 . 1' . 1'' ), wherein the at least one dermal interface ( 8th ) to the bag ( 1 . 1' . 1'' ) or in the bag ( 1 . 1' . 1'' ) is inserted or molded, the bag ( 1 . 1' . 1'' ) at least one first chamber ( 10 ) to hold the substance or a solvent, and the bag ( 1 . 1' . 1'' ) at least one second chamber ( 11 ) to the first chamber ( 10 ) with the dermal interface ( 8th ) fluidically, characterized in that the bag ( 1 . 1' . 1'' ) at least one releasable clamp and / or at least one seam which can be separated at least in one seam section ( 9 ), wherein the clamp and / or the separable seam, the at least a first ( 10 ) from the at least one second chamber ( 11 ) separates. Device according to one of the preceding claims, characterized in that the dermal interface ( 8th ) insoluble with the bag ( 1 . 1' . 1'' ) connected is. Device according to one of the preceding claims, characterized in that the dermal interface ( 8th ) to a bag surface ( 2 ) of the bag ( 1 . 1' . 1'' ) or in a bag surface ( 2 ) of the bag ( 1 . 1' . 1'' ) is inserted or molded. Device according to one of the preceding claims, characterized in that the bag ( 1 . 1' . 1'' ) at least one bag seam ( 6 ) and the dermal interface ( 8th ) in a bag seam ( 6 ) is used. Device according to one of the preceding claims, characterized in that the dermal interface ( 8th ) a connection port ( 19 ), with which it is inserted into the bag ( 1 . 1' . 1'' ) or attached to the bag ( 1 . 1' . 1'' ) is formed. Device according to one of the preceding claims, characterized in that the bag ( 1 . 1' . 1'' ) is formed of one or more flexible films. Device according to one of the preceding claims, characterized in that the bag ( 1 . 1' . 1'' ) two substantially superposed bag surfaces 2 . 3 having. Device according to one of the preceding claims, characterized in that it comprises at least one filling port ( 25 ) to at least the first chamber ( 10 ) with the substance or the solvent to fill. Device according to one of the preceding claims, characterized in that it comprises a detachable cover ( 22 ) for the dermal interface ( 8th ). Device according to one of the preceding claims, characterized in that the device comprises at least one holding device to the bag ( 1 . 1' . 1'' ) and / or the dermal interface ( 8th ) on the skin. Device according to one of the preceding claims, characterized in that the dermal interface ( 8th ) has at least one opening facing the skin Device according to claim 11, characterized in that the at least one skin-facing opening of the dermal interface ( 8th ) is partially or completely enclosed by an adhesive layer. Device according to claim 12, characterized in that the adhesive layer of the at least one skin-facing opening of the dermal interface ( 8th ) on the dermal interface ( 8th ) or on the bag or on the housing into which the dermal interface ( 8th ) is installed. Device according to claim 11, characterized in that the at least one skin-facing opening of the dermal interface ( 8th ) into the skin or through the skin. Device according to one of claims 11 to 14, characterized in that the dermal interface ( 8th ) at least one skin penetrating element ( 18 ). Device according to one of claims 11 to 15, characterized in that the dermal interface ( 8th ) comprises a substance permeable membrane or nonwoven fabric.

Images