HK1162913B - Flexible container with insert part - Google Patents

Description

Flexible container with insert portion

Technical Field

The present invention relates to a flexible container for storing a liquid medicament to be administered to a patient by an infusion pump device, an insertion part for use with such a flexible container, and a device for automated release of a liquid medicament comprising, incorporating and/or being able to use such a flexible container, according to the preambles of the independent claims.

Background

Devices for the automatic release of liquid medicaments are generally used for patients with a continuous and during the day varying need of a drug that can be administered by subcutaneous injection. Particular applications are, for example, certain pain treatments and the treatment of diabetes, where computer-controlled infusion pump devices, such as insulin pumps, are used. Such devices may be carried on the body by a patient and contain a quantity of liquid medicament in a medicament reservoir in the form of a container. The drug reservoir often includes enough drug for one or more days. The liquid medicament is supplied to the body of the patient from the medicament reservoir through a syringe or injection needle.

Especially in the case of automatic administration of medicaments, such as insulin, the patients using the medicament in question and administering them themselves by means of an infusion pump are increasingly emphasised by convenience and caution. As a result, the size of such injection devices is limited and in particular the overall length, width and thickness should be as small as possible in order to be less visible through clothing and to be carried as comfortably as possible.

While there are fully or partially disposable infusion pump devices, such devices are typically not disposable and are loaded with disposable cartridges. Disposable cartridges are preferred for sterility and contamination protection reasons. It may be delivered pre-filled with a certain liquid medicament, or empty, ready to be filled by the user. Such automatic filling of the container has the advantage that also medicaments which are not readily available in the pre-filled container can be used in such infusion pump devices, thereby providing the patient with a greater choice of sources for their medicaments. Furthermore, the stability of many medicaments in liquid form (especially in plastic containers) can only be guaranteed for certain days by the manufacturer.

Standard infusion pump devices carried on or near the body have a drug reservoir with a cylindrical ampoule and a positive displacement piston which is pushed into the ampoule by a piston rod or threaded spindle in order to deliver the liquid medicament. These known designs have the disadvantage of being longer and/or thicker than desired, with the resulting size being detrimental to the provision of a compact infusion pump.

Manufacturers have attempted to meet the needs of small infusion pump devices by various means. For example, an infusion pump may be divided into structural components, each disposed in its own smaller housing, and capable of being engaged with each other by a wireless or wired connection. An example of such a modular infusion pump device is disclosed in US 2006/0184119 a 1.

Another possibility is the use of containers of particularly flat construction. For example, instead of a cylindrical cylinder, a container with a rectangular or another suitable cross-section may be used, which interacts with a correspondingly shaped positive displacement piston. Different embodiments of such compact drug reservoir devices are shown in WO 2008/122135 a 1.

Another method of reducing the overall volume of an infusion pump device is to replace the syringe-type dose metering mechanism with a downstream pump system, wherein a piston is displaced along a long container axis by an actuator, thereby delivering the appropriate amount of liquid drug. In such devices, a miniaturized pump is arranged downstream of the reservoir and induces a suction pressure from the delivery of the product from the reservoir to its destination. An example for such a pump is WO 2004/009162 a 1.

For some of these infusion pump devices, the suction pressure achievable with such pump systems is not very high. A suitable container for such a device is disclosed in US 2007/0123820 a1, which comprises a flat container and a flat piston body arranged in a sliding manner in a main body. Such a container, when fully filled, has a ratio between its maximum height and its total width of less than 1.25. The cross-sectional area of the reservoir relative to the axis of displacement is much larger than for conventional cylindrical piston arrangements and the rather small pressure gradient created by the miniaturised pump is able to overcome the friction of the piston seal sliding on the inner reservoir wall.

In a particularly advantageous method, the rigid container and the movable piston are replaced by a flexible container. Such a flexible container may, for example, be in the form of two flexible wall sheets sealed together. Flexible containers have the advantage of a smaller volume surplus of the container with respect to its contents, which reduces the manufacturing costs and the achievable dimensions of an infusion pump device using such flexible containers. The solvent of the flexible container for use in the infusion pump device may be up to e.g. 10 ml. A typical range for diabetes treatment is 1.5 to 3.5 ml. For other treatments requiring other delivery regimes, such as pain treatment, other volume ranges may be more preferred.

For use in an infusion pump device, the flexible container must be connected to the catheter system of the device. To this end, a port may be provided for the flexible container. Such ports may be mounted on the container with a flange sealed to the container wall sheet. US 2007/0049865 a1 discloses such containers. The port is provided with a septum to be pierced by a hollow needle of the catheter system of the infusion pump device. Another possibility for a flexible container is a port in the form of a flexible tube or a rigid connection welded between two sheets of containers at the periphery of the flexible container. Fastening of the port to the container, for example by gluing or welding, requires precise production control to avoid high scrap rates and, in addition, limits the choice of suitable materials.

A common problem with flexible containers having ports used (e.g., in IV bags) is the dead volume caused between the collapsed container and the port. The dead volume cannot be used, meaning that it cannot be emptied. Thus, complete draining of the contents of the flexible container is not possible. The resulting loss of usable container volume due to dead volume is particularly high for smaller containers, as it is suitable for infusion pumps having a total volume of only 5ml or less. In a standard liquid medicament container for an infusion pump device, the dead volume may be in the range of at least 5% of the total volume. For flexible containers according to the invention, the remaining dead volume is in the range of 1 to 2% or less. For single-use containers filled with a medicament, the dead volume considerably increases the effective cost per dose and therefore the total treatment cost, since a certain percentage of the medicament will inevitably remain in the container and have to be disposed of. This cost effect is particularly important for expensive pharmaceutical agents. In addition to increased costs, the dead volume also leads to an increase in the total volume of the flexible container and thus of the infusion pump device with such a flexible container.

Another problem, in particular with flexible containers as known, is the air left in the container. If, for example, an empty flexible container is provided, intended to be filled with the appropriate medicament by the user himself, the dead volume is initially filled with air. However, removing air from a flexible container as known from the prior art would require some skill of the user. If the air is left in the container or in the fluid system of the pump system, air bubbles may be administered instead of the liquid medicament, which results in potentially dangerous dosage errors. Furthermore, for medical reasons, the administration of air into the body of a patient should generally be avoided.

Another problem with air in fluid systems is the reduced stiffness of the fluid system. Due to the high compressibility of gases such as air relative to liquids such as water, it becomes difficult to measure accurate pressures in fluid systems. This prevents detection of blockages or occlusions in the fluid system of the infusion pump device by measuring the fluid pressure.

Object of the Invention

It is an object of the present invention to provide a flexible container for storing a liquid medicament to be patient-based, which does not comprise the drawbacks of the known containers. In particular, the flexible container according to the present invention should be easily connected to a device for automated release of a liquid medicament. Furthermore, the flexible container according to the present invention should have a reduced dead volume and should be easily connected to a device for automated release of a liquid medicament. It should also be of a size suitable for carrying on or near the body.

In addition, the flexible container according to the invention should be producible at low cost with high quality and should comprise a minimum number of components.

It is a further object of the present invention to provide an advantageous insert part for use in such a flexible container, which allows to fluidly connect the flexible container with a connecting means for connecting the flexible container with a means for automated release of a liquid medicament.

It is a further object of the present invention to provide a device for automated release of a liquid medicament comprising, incorporating and/or enabling the use of such a flexible container.

These and other objects are achieved by a flexible container, an insertion part and an infusion pump device according to the independent claims. Advantageous embodiments are given in the dependent claims.

Disclosure of Invention

The flexible container for storing a liquid medicament according to the invention comprises a container wall consisting of two wall sheets of flexible material sealed together. The container comprises a storage chamber for the liquid medicament and an access opening (access opening) in one of the wall sheets. The storage chamber and the patch jack are fluidly connected, and the access opening is designed to be fluidly connected to an external conduit system. The insertion portion is arranged between the two wall sheets with positive locking and fluidly connects the reservoir and the access opening.

The access opening of the flexible container is intended to be fluidly connected to the outer catheter system of the infusion pump device, either directly or using a suitable connection means.

This form-fitting locking is achieved by the interaction of the elements of the insert part with the elements of the wall sheet. For example, the periphery of the insertion section can be positively locked between the adjacent wall sheet and the sealing edge of the wall sheet. In this case the direction of the locking force is substantially parallel to the wall sheet. The insertion portion may have some play parallel to the wall sheet as long as a fluid connection between the storage chamber and the access opening is created via the insertion portion.

In an advantageous embodiment of the flexible container according to the invention, the insertion section is arranged and positively locked in different access areas of the container. Preferably, the access region is separated from the reservoir by a neck or constriction.

In a further advantageous embodiment of the flexible container according to the invention, an element for positioning and/or fixing the flexible container in a connection device, in particular in a connection device of an infusion pump device, is provided.

Preferably, said elements for positioning and/or fixing are two or more holes and/or grooves and/or protrusions arranged in the sealing area of the container and/or in the area of the wall sheet outside the sealing area not belonging to the storage chamber.

In a further advantageous embodiment of the flexible container according to the invention, the access opening comprises a hole arranged in the wall sheet adjacent to the insertion portion, preferably above the opening of the duct system of the insertion portion. The access opening may, for example, have a diameter of about 1.5mm or less. In the described embodiments of the flexible container, the insertion portion may comprise a sealing lip arranged on an upper surface of the insertion portion, wherein the sealing lip protrudes through the aperture of the access opening.

In a preferred variant of the described embodiment of the flexible container, the form-fitting locking of the insertion section in the flexible container is at least partially achieved by a sealing lip protruding through the aperture of the access opening.

The flexible container according to the invention may preferably comprise a connection device for use in an infusion pump device, the connection device comprising two clamping portions adapted to positively and/or non-positively lock the flexible container and to fluidly connect the access opening of the flexible container to the tubing system of the connection device. Typically, in a variant of the flexible container, the access opening is not directly accessible. Preferably, the flexible container and the connecting means are provided as a compact pre-assembled unit.

In a preferred embodiment of such a flexible container, the clamping portion facing the access opening comprises a sealing element adapted to fluidly connect the duct system with the access opening of the flexible container.

In another preferred embodiment of such a flexible container, the surface of the holding portion of the connecting device is adapted to the outer shape of the flexible container, in particular the outer shape of the access area of the container.

Additionally or alternatively, one or both clamp parts may also comprise a resilient element directed towards the opposite clamp part in order to increase the frictional locking of the container or to improve the sealing.

The connection device may comprise other functional elements such as, for example, a bubble trap, a pressure sensor or a pressure transfer membrane for coupling the conduit system of the connection device to the pressure sensor. It may also comprise a pumping/dosing mechanism or a part of a pumping mechanism, such as a micro membrane pump or a micro piston pump.

In a particularly preferred embodiment of the container according to the invention, the container comprises a bubble trap. Such bubble traps may be wholly or partially integral parts of the container. More preferably, it may comprise a Bubble trap as disclosed in european patent application No. 09155216.6 entitled "Bubble trap system for an infusion pump device" filed by the applicant on the same day as the present application.

The connecting means may also comprise other functional elements, such as, completely or partly, diaphragms, degassing membranes, pressure sensors, pressure transfer membranes, pump chambers and/or pumping mechanisms. The connection means may also be implemented as an integral part of the flexible container, permanently mounted thereon, or as an integral part of the infusion pump device.

In an advantageous embodiment of the flexible container comprising the connecting means, the connecting means comprise elements for positioning and/or fixing the flexible container, such as positioning bolts, which preferably interact with the elements for positioning and/or fixing of the flexible container.

A preferred embodiment of the flexible container according to the invention is an insert part according to the invention as will be described further below.

In addition, flexible containers according to the present invention may be provided with one or more additional ports mounted to the container wall in addition to the access region. These additional ports may be used to transfer liquid to and from the reservoir of the container or may be used to remove air from the container if desired. In particular, the container according to the present invention may comprise one or more ports as disclosed in the applicant's european patent application No. 08167548, which is incorporated herein by reference in its entirety as part of the present disclosure. The flexible container according to the invention may also have structural elements of the flexible container as disclosed in said application.

Furthermore, the flexible container according to the invention may comprise an additional pre-formed discharge channel formed by two wall sheets. The applicant's european patent application No. 08170627 discloses many possible variants of such discharge channels. The access area of the container and the storage chamber may for example be connected by one or more such additional discharge channels. The contents of said application are incorporated by reference herein in their entirety as part of the present disclosure.

Since essentially all elements required for fluidly connecting the flexible container to the infusion pump device are arranged inside the container and no large external ports are required, the total volume of the container according to the invention and thus the infusion pump device with such a device is considerably reduced. At the same time, the dead volume is kept at a minimum.

Typically, the flexible container according to the present invention will be provided hermetically closed and sealed to maintain the sterility of the interior of the container. The container will be completely or partially filled with the liquid medicament or will be empty.

An insert part according to the invention for use in a flexible container according to the invention comprises a substantially flat body having a first, upper surface and a second, lower surface and an inner conduit opening towards the upper surface. The internal conduit is fluidly connected to one or more vent channels and/or a network of vent channels that lead to the outer edge of the insertion portion body.

In an advantageous embodiment of the insertion part according to the invention, the one or more drainage channels are embodied as dimples arranged on the lower surface and/or as tubular conduits arranged inside the body of the insertion part.

In a further advantageous embodiment of the plug-in part according to the invention, one or more positioning elements are provided which are adapted to positively lock the plug-in part in the flexible container.

In a further advantageous embodiment of the insertion part according to the invention, a sealing lip is arranged on the upper surface in order to sealingly connect the interior with the external duct system. The sealing lip is preferably composed of a material having a higher elasticity than the material of the body of the insertion portion. Alternatively, the sealing lip may be composed of the same material as the body of the insert portion. In any case, the elasticity of the sealing lip should be higher than the elasticity of the counterpart of the connecting device interacting with the sealing lip.

In another advantageous embodiment of the insert part according to the invention, the insert part comprises a secondary sealing lip arranged on the upper surface for sealingly connecting the upper surface with an adjacent wall sheet of the flexible container.

The insertion part according to the present invention may further comprise a septum arranged in the inner catheter.

When mounted in a flexible container, the substantially flat upper surface of the insert part according to the invention is located adjacent to the wall sheet. An internal conduit leading to the flat upper surface of the insertion portion opens to the access opening in the wall sheet.

The insert part is arranged with form-fit locking within the flexible container according to the invention and therefore does not have to be mechanically attached to the wall sheet. Such containers may therefore consist of only three parts, of which only two, i.e. the wall sheets, have to be sealingly connected along the peripheral sealing edge. When one single folded sheet is used instead of two separate wall sheets, even only two parts are sufficient for the container according to the invention. This uncomplicated design of the flexible container according to the invention simplifies the assembly of the container and thus reduces the manufacturing costs. Furthermore, since the insert portion does not have to be attached directly to the wall sheet of the container, there is no need to select materials for the insert portion and adjacent layers of the wall that are compatible to be sealed together, which provides more flexibility for the manufacturer in selecting the most appropriate material for a certain purpose.

The flexible container according to the invention must be connected to the infusion pump device by means of a suitable connection device. The connecting means interact with a specific access area of the container in which the insert part is arranged. The sealing element of the connecting device and/or the insert part provides a fluid-tight connection between the conduit system of the connecting device and the access opening of the container.

After the liquid-tight seal has been established, the storage chamber of the container is finally fluidly connected to the tubing of the connecting device via the network of discharge channels and the inner tubing of the insert portion. The infusion pump device is now able to aspirate the liquid medicament from the container. When the pump device of the infusion pump arranged downstream of the tubing system of the connection device draws liquid, the liquid medicament in the container flows from the reservoir to the access opening through the network of discharge channels and the inner tubing of the insertion portion and then to the pump device via the tubing system. The container, which is completely or partially filled at the beginning, will continuously collapse until the last two wall segments abut each other. The flexible container may also be filled or refilled via the connecting means.

An advantageous device for the automated release of liquid medicament, in particular an infusion pump device, comprises, incorporates or is able to use a flexible container according to the invention.

The terms "medicament" and "liquid medicament" as used herein are intended to encompass any flowable drug containing drug, or therapeutic or diagnostic liquid, capable of being delivered in a controlled manner through a delivery element such as a hollow needle, such as a liquid, solution, gel or fine suspension. Typical drugs include pharmaceuticals such as peptides, proteins and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form. In particular, the term medicament encompasses insulin preparations intended for administration.

The terms "subcutaneous injection" and "subcutaneous infusion" are intended to encompass any method of inserting a needle device at any selected site within the body of a patient to deliver a liquid medicament to the subcutaneous, intravenous, intramuscular, or intradermal space of a subject. Furthermore, the term needle defines a piercing member (including a microneedle array) adapted to be introduced into or through the skin of a subject.

The terms "vent channel" and "vent channel network" are intended to encompass any arrangement of dimples and protrusions on a surface that provides sufficient interconnected space between the surface and a flexible sheet that is firmly abutted to the surface through which fluid can flow.

Drawings

In order to facilitate a further understanding of the invention, reference is now made to the accompanying drawings. These references should be understood as limiting the invention, but are intended to be exemplary only.

Fig. 1 schematically shows an embodiment of a flexible container according to the present invention (a) in a perspective view and (b) in an exploded view.

Fig. 2 (a) shows a view onto the lower and upper surface and in a side view and (b) shows schematically in a perspective view onto the lower and upper surface an insert part according to the invention as shown in fig. 1.

Fig. 3 schematically shows a flexible container according to the invention in a cross-section through the connecting means perpendicular to the longitudinal axis of the container, which interacts with a possible embodiment of the connecting means.

Fig. 4 (a) shows a view onto the upper and lower surfaces and in a side view and (b) shows schematically in a perspective view onto the lower and upper surfaces another embodiment of an insert part according to the invention.

Fig. 5 (a) in side view, (b) in cross-section through plane a-a, and (c) in top view schematically shows another embodiment of an insert part according to the invention, while fig. 5 (d) shows an access area of a container according to the invention with such an insert part.

Fig. 6 (a) (b) in perspective view onto the lower surface, and (c) (d) view onto the lower surface schematically show four different variants of the discharge channel arrangement for the insertion section according to the invention.

Fig. 7 shows schematically another variant of the flexible container according to the invention (a) in a cross-section perpendicular to the axis of the tubular element, (b) in a cross-section along the axis of the tubular element, and (c) in a top view.

Fig. 8 (a) shows an embodiment of the insert part according to the invention in side view, (B) in cross-section through plane a-a, (c) in top view, and (d) schematically in cross-section through plane B-B.

Fig. 9 schematically shows a flexible container according to the invention in a cross-section through the connecting means perpendicular to the longitudinal axis of the container, interacting with a possible embodiment of the connecting means, with an insertion portion comprising a needle stop.

Fig. 10 schematically shows two embodiments of a flexible container according to the invention in top view, wherein the container comprises one compartment.

Fig. 11 (a) shows an embodiment of an insertion portion according to the present invention in a top view, (b) in a side view, (c) in a bottom view, and (d) in a perspective view.

Fig. 12 (a) shows the flexible container according to the invention in a fully depleted condition, (b) in a filled condition, and (c), (d) in a cross-section through the connecting means perpendicular to the longitudinal axis of the container.

Fig. 13 (a) shows in side view, (b) in cross-section through plane D-D, (c) in top view, and (D) in perspective view schematically an embodiment of an insert part according to the invention, comprising primary and secondary sealing lips.

Fig. 14 schematically shows, in a cross-section through the connecting means perpendicular to the longitudinal axis of the container, a flexible container according to the invention as disclosed in fig. 13, with its interaction with a possible embodiment of the connecting means.

Fig. 15 (a) shows a further embodiment of an insert part according to the invention in side view, (B) in cross-section through plane B-B, (c) in top view, and (d) in perspective view onto the lower surface.

Fig. 16 schematically shows, in a cross-section through the connecting means perpendicular to the longitudinal axis of the container, a flexible container according to the invention as disclosed in fig. 15, with its interaction with a possible embodiment of the connecting means.

Fig. 17 schematically shows, in a cross-section through the connecting means perpendicular to the longitudinal axis of the container, another flexible container according to the invention as disclosed in fig. 15, which is permanently sealed to the adjacent wall sheet.

Detailed Description

One possible embodiment of a flexible container 1 according to the invention is shown in fig. 1 (a) in a perspective view and fig. 1 (b) in an exploded view. The flexible container essentially consists of two wall sheets 101, 102 of flexible, liquid-tight material which are sealed along the circumferential sealing edge 13 and an insert part 2 arranged between the two wall sheets. This insertion portion is shown in more detail in fig. 2.

In fig. 1, the container 1 is shown in an empty, fully depleted state. The container shown essentially comprises two distinct compartments separated by a neck 16, namely a storage chamber 11 in which the liquid content is stored and an access area 12 substantially filled by the insert portion 2. The shape of the access region 12 and the neck 16 is adapted to the shape of the insertion section 2 in order to positively lock the insertion section 2 within the container 2 and to minimize the dead volume in the access region. The periphery of the insertion portion is positively locked between two adjacent wall sheets 101, 102 and the sealing edge 13 of the wall sheet. The direction of the locking force is substantially parallel to the wall sheet. By properly adjusting the manufacturing process, a perfect fit of the insert part within the container can be obtained. However, the insertion part 2 may also have some play parallel to the wall sheet, as long as a fluid connection between the storage chamber and the access opening 121 is created via the insertion part 2.

The embodiment of the insertion part 2 according to the invention has a flat, drop-like shape with a central circular body part and a tongue part. The edges of the insertion portion are beveled in order to minimize the dead volume between the sealing edge 13 and the insertion portion 2 and to avoid mechanical stress on the preferably thin wall sheet. The insert portion has a substantially flat upper surface 211 and a lower surface 212. The single discharge channel 22 is arranged on the lower surface 212 of the insertion portion, connected to the upper surface 211 by the internal conduit 23, realized as an internal bore (bore) arranged in the centre of the insertion portion. The discharge passage 22 is realized as an oblong recess in the lower surface 212, leading from the central inner conduit 23 to the end of the tongue portion, opening out into the reservoir. The volume of the discharge channel 22 and the internal conduit 23 is much smaller than the total volume of the vessel, so its contribution to the dead volume of the vessel is negligible.

The sealing of the two wall sheets 101, 102 may be achieved by heat sealing, ultrasonic welding, high frequency induction welding, gluing or any other suitable method for producing a flexible container from sheet material known to the skilled person. The sheet material may be a single foil or a composite foil of a suitable polymer. The base region of the flexible container according to the invention may have any suitable shape, in particular square, rectangular, circular, oval, hexagonal. The shape may also be specifically adapted to a specific infusion pump device. As an alternative to sealing the two separate sheets together, it is also possible to create the walls of the container by folding a single sheet along the axis and sealing along the remaining edges. Another possibility known from the prior art is to use a continuous film tube for producing the container.

The material of the wall sheet may be a single layer film or a multi-layer structure. Preferably, the wall sheet consists of one or more polymers of the following families: polypropylene (PP), Polyethylene (PE) and copolymers; ethylene Vinyl Acetate (EVA), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), Polystyrene (PS), ethylene vinyl alcohol (EVOH), polyethylene terephthalate (PET), Polyamide (PA), Polychlorotrifluoroethylene (PCTFE), Cyclic Olefin Copolymer (COC), thermoplastic elastomer (TPE), or any other polymeric material known to the skilled person to be suitable for this purpose. The wall sheet can be manufactured, for example, by extrusion, blown film extrusion, co-extrusion or lamination. When creating a multilayer structure, it may be desirable to include one or more tie layers, or to apply one or more adhesive layers between the functional layers. To improve the barrier properties, metallized films may also be used, or a silicon oxide or aluminum oxide coating may be applied.

The insert portion may be composed of any suitable rigid or semi-rigid material, including glass, ceramic, metal, or a suitable polymer. Preferably, the insertion part may consist of a polymer of the family: polypropylene (PP), Polyethylene (PE) and copolymers; ethylene Vinyl Acetate (EVA), polyvinyl chloride (PVC), silicone, or any other polymeric material known to the skilled person to be suitable for this purpose. If the insert part comprises a protruding sealing lip, preferred materials for the insert part are thermoplastic elastomers, elastomers and silicones, or any other suitable material that is relatively soft and resilient. The same applies to the sealing lip if it is made of another material than the body of the insert part. The insert portion may be manufactured by any suitable method, depending on the material used. If a polymer is used, injection molding is the most preferred method of manufacture.

Since there is no material bond between the insert portion and the wall sheets of the container, there is no need to select compatible materials for the adjacent layers of the insert portion and the wall, which provides flexibility to the manufacturer in selecting the most appropriate material.

The shape of the insertion portion as shown in fig. 1 and 2 has the advantage that the insertion portion can be easily produced by injection moulding, since no undercuts (undercuts) are present. The discharge channel in the form of a rectangular pit ensures a continuous fluid connection between the access opening and the reservoir even when the container is completely depleted. The tubular connection formed by the discharge channel 22 and the adjacent wall piece 102 does not collapse even under the external force of the clamping element of the connecting device or due to the pressure difference between the interior and the exterior of the container.

Alternatively, the discharge channel may be arranged on the upper surface of the insertion portion, in which case no internal conduit is required. However, such an embodiment would be detrimental to the sealing effect between the insertion portion and the wall sheet in the annular area around the access opening, since the relevant area would not be completely flat.

In the embodiment of the flexible container depicted in fig. 1, the wall sheet is substantially flat. Therefore, the insertion portion must also be as flat as possible to avoid folding of the wall sheet. In an alternative embodiment, one or both wall sheets may be provided with a hollow, in which the insertion portion may be arranged. Such embodiments have the advantage of being able to use a more bulky insert, which may for example contain additional features such as a membrane or bubble trap.

Instead of a completely flat surface of the insertion portion, the upper surface facing the connecting device may also be convex, if the shape of the sealing and pressure elements of the connecting device is adapted to this particular shape.

In another advantageous embodiment of the invention, the drainage channel network of the surface of the insertion portion extends to the wall sheet of the flexible container. This may be achieved, for example, by hot embossing grid lines on at least a portion of the inner surface of one or both wall sheets. In such embodiments, the network of drainage channels of the insert portion is connected to the network of embossed grid lines. When the container collapses in a suboptimal manner during emptying, no portion of the contents of the container can be blocked and separated from the insertion portion, even for very large containers or very flexible container wall sheets, since liquid can always flow through the grid line network to the insertion portion.

Possible geometries of the flexible container according to the invention are not limited to the substantially rectangular shape as shown in fig. 1, although a rectangular shape is efficient and therefore advantageous. The shape of the flexible container may be adapted to any particular need, in particular the size of certain pump devices. The same is true for the shape, location and size of the reservoir.

The technical interaction between the flexible container according to the invention and the infusion pump device is depicted in more detail in fig. 3, fig. 3 showing the flexible container 1 according to the invention in a cross section perpendicular to the longitudinal axis 15 of the container through the connection means 3 and the inner conduit of the insertion part, which interacts with the connection means 3 of the infusion pump device (not shown).

The illustrated attachment device 3 includes a lower clamp portion 31 and an upper clamp portion 32 made of a stable, rigid material such as metal or a suitable polymer. The access area of the flexible container according to the invention with the insert part 2 is sandwiched between the two holding parts 31, 32, the upper surface 211 of the insert part facing upwards towards the holding part 32. The upper clamp portion 32 comprises a catheter system 33 connected to an infusion pump device (not shown) in which a membrane 331 is arranged. The duct system 33 is aligned with the inner duct 23 and the access opening 121 of the insertion part 2.

A sealing element 34 in the form of an O-ring is arranged on the upper clamping portion 32, facing the insertion portion 2 and pressed against the wall sheet 101. The O-ring 34 thus provides a circumferential seal between the duct system 33 of the connection device 3 and the access opening 121 of the flexible container.

After the desired seal has been established, the storage chamber 11 of the container is now fluidly connected to the conduit system 33 of the connecting means via the discharge channel 22, the internal conduit 23 and the access opening 121. The catheter system 33 may be connected to an infusion pump device (not shown) via a separate catheter opening into the catheter system 33 or via a hollow needle arranged in the membrane 331.

The diaphragm 331 provided in the illustrated embodiment of the connection means, for example made of a silicon polymer, is only an optional feature. Through the septum 331, a user may access the catheter system 33 and/or the container 1 with a syringe by piercing the septum with a hollow needle. He may, for example, fill or refill the container with a liquid medicament originating from a larger container, or he may clean the conduit system or remove air from the system.

After having inserted the appropriate end 12 of the flexible container 1 between the two clamping portions 31, 32 of the connecting device, the two clamping portions 31, 32 are locked together. The skilled person will know many different methods for frictionally or form locking the two parts. For example, one clamping part may be fitted with a latch which is inserted into a corresponding hole in the other clamping part. The catch may at the same time be used for positioning and/or fixing the container, for example if the container comprises a corresponding hole in the sealing area of the wall sheet (see for example the embodiment of the container according to the invention disclosed in fig. 7 (c)). In an advantageous embodiment, the catch is inserted into a hole of the receptacle, thereby fixing its position in a defined manner relative to the holding portion. European patent application 08170627 of the present applicant discloses such a clip-locking system, which may also be applied to flexible containers according to the present invention.

The connection device 3 may comprise other functional elements such as, for example, a bubble trap, a pressure sensor or a pressure transfer membrane for coupling the conduit system 33 of the connection device to the pressure sensor. Furthermore, it may comprise a pumping/dosing mechanism or a part of a pumping mechanism, such as a micro membrane pump or a micro piston pump.

The connection device according to the invention may be embodied as a separate unit, as shown in fig. 2, or may be permanently attached to the flexible container, or may be directly attached to the infusion pump device. For example, the lower clip portion 51 may be an integral part of the ground plate of the infusion pump device. The flexible container itself may be easily removable from the infusion pump device, or it may be an integral part of the device. In the former case, the user, in particular the patient using the device, may replace the empty container with a new pre-filled single-use container, or he may remove the container for refilling. For quality assurance reasons, replaceable single-use containers are highly preferred. In the latter case, the container is refilled directly in the device, for example by connecting a septum in the device or by an additional port mounted on the container. This can be done by the user himself or by a maintenance service if the container has to be replaced for maintenance reasons.

The insertion portion 2 of the flexible container disclosed in fig. 1 and 2 is designed to be positioned in a single, clearly defined orientation within the container 1. However, the insertion portion may alternatively be implemented in a manner that allows for multiple orientations. Such an embodiment of the insertion portion 2 is depicted in fig. 4. The insertion part 2 has a substantially disc-shaped form, with an inner conduit 23 arranged in the centre of the disc. On one surface of the disc, six discharge channels 22 are symmetrically arranged, radiating from the inner conduit 23 towards the peripheral edge and forming a discharge channel network 221.

A rotationally symmetrical insert part as shown in fig. 4 has the advantage that only the orientation of the two surfaces 211, 212 has to be correct. However, it does not matter how the insertion portion is rotationally oriented along its central axis. If the neck 16 of the flexible container is chosen to be sufficiently wide, in each orientation angle at least one discharge channel 22 will open to the reservoir, providing a fluid connection 22, 23 between the access opening 121 and the reservoir 11. This independence of orientation angles significantly simplifies the assembly process of the flexible container with the insert portion.

In fig. 5 a further embodiment of an insert part 2 for use in a flexible container 1 according to the invention is shown, wherein eight tubular discharge channels 22 are arranged radially inside the body 21 of the insert part 2. The assembly of the flexible container with such an insert part 2 is even simpler than with the insert part of fig. 4, since the two surfaces 211, 212 are identical. Fig. 5 (d) depicts an access area of a flexible container 1 according to the invention, in which the insert part is arranged in a form-fitting locking.

A further advantage of the insert part 2 as shown in fig. 5 is that possible dead volume in the peripheral region between the sealing edge 13 and the edge of the insert part can also be accessed by the discharge channel 22 facing towards the sealing edge 13. Furthermore, due to the certain stiffness of the wall sheets close to the sealing edge, there may be a circumferential channel around the flexible container between the two wall sheets close to the sealing edge 13. It is thus also possible to evacuate the peripheral zone and the circumferential channel, thereby further reducing the dead volume.

Other examples of possible arrangements of the discharge channels 22 of the embodiment of the insertion section 2 are given in fig. 6. Fig. 6 (a) shows another embodiment of the insertion part 2, three discharge channels 22 being arranged in a star-like manner on the lower surface 212 of the insertion part 2. In the variant of fig. 6 (b), a number of protrusions 222 are arranged on the lower surface 212 of the insertion portion 2, the gaps between said protrusions forming a network 221 of discharge channels 22. In the embodiment of fig. 6 (c), three straight and two circular discharge channels 22 are arranged on the surface 212, whereas in fig. 6 (d) the discharge channels 22 form a grid-like network 221.

Typically, the vent channels should be as shallow as possible in order to reduce dead volume. The achievable minimum depth of the discharge channels 22 of a given channel network 221, in order to avoid channel clogging, among other factors, depends on the flexibility of the material of the wall sheet 102 and the width of the channels 22. Furthermore, a given minimum flow rate must be ensured, which depends, for example, on the requirements of the dispensing pump and on the viscosity of the liquid medicament.

In fig. 7 a further advantageous variant of a flexible container 1 according to the invention is shown. In this particular embodiment, the insertion portion 2 is realized as a tubular element arranged in the access area 12 of the flexible container 1, parallel to the longitudinal axis 15. The access opening 121 is arranged on top of the tubular insertion part 2. One open end of the tubular insertion portion 2 is open to the storage chamber 11, and the other end is blocked by the sealing edge 13. Both the discharge channel 22 and the inner conduit 23 of the tubular insertion portion are provided by the inner space of the tubular element. The sealing element and the pressure element of the connection device must be adapted to the particular form of the non-flat form of the wall sheet surface around the access opening 121.

An advantage of such an embodiment of the flexible container is that a very simple insert part can be used, which can even be provided continuously during manufacture, e.g. supplied from a spool. In an alternative version, the tubular insertion portion may even protrude into the storage volume chamber of the container. In another variant, the tubular insertion portion may be curved in a semi-circle with both ends facing the storage chamber. The access opening may then be located in the middle of the tubular element 2.

In the embodiment of the flexible container 1 disclosed in fig. 7 (c), the sealing edge 13 is widened in the access area 12 and forms a sealing area 14. In said area 14 four holes are arranged, which act as positioning elements 17 for accurately positioning the flexible container 1 in the connecting device. For example, the attachment means may comprise a positioning peg which interacts with the positioning hole 17. In another possible variant, the positioning element is a groove or a protrusion in the sealing area 14, which interacts with a protrusion and/or a groove arranged on the clamping portion. The use of positioning elements is also advantageous in the context of all other embodiments of flexible containers according to the invention having other types of insertion portions. In an increasingly advantageous variant, as is realized in fig. 7 (c), the positioning elements 17 are arranged asymmetrically. This will allow to connect the container 1 to the connection means in only one possible way, which deduces the risk of the user performing an erroneous operation.

When piercing the access opening of the flexible container according to the invention, care must be taken not to accidentally penetrate both wall sheets, which would compromise the sealing of the connection between the container and the connecting means. As shown in fig. 8 and 9, this may be achieved by an optional needle stop 24 arranged in the insertion portion 2.

In the insertion section 2 shown in fig. 8 and 9, the inner conduit 23 is realized as a blind hole, the remaining rigid wall of the surface 212 opposite the connecting means 3 acting as a needle stop 24. When the needle 332 is pushed through the septum 331 and the upper wall sheet 101, the needle stopper 24 prevents the tip of the needle 332 from reaching the other wall sheet 102. The needle stop 24 as shown in fig. 8 and 9 can be used not only in an insertion section with a tubular discharge channel 22, but also in an insertion section with a discharge channel realized as a rectangular recess, such as the one given in fig. 1 to 4.

In the embodiments of the flexible containers discussed so far, the insert part is fixed within the container by form-fittingly locking the insert part within a compartment separated from the storage chamber by a neck or constriction. However, the flexible container according to the invention may also comprise only one compartment, serving both as storage compartment and access area. Two possible examples of such flexible containers according to the present invention are shown in fig. 10.

In the embodiment shown in fig. 10 (a), the internal compartment comprises at its periphery a protrusion 12 in which the body 21 of the insertion portion 2 is arranged. Since the projection 12 is not undercut, the previously discussed insertion part 2 will not be positively locked within the access area 12 formed by the projection 12. To this end, the insert part 2 in fig. 10 (a) comprises a hoop-like positioning element 25 which is located inside the storage chamber 11 along the sealing edge 13, thereby positively locking the insert part 2 within the container 1. In addition, the disclosed insertion part 2 comprises optionally two distance elements 26, which protrude into the storage chamber 11. When the flexible container 1 is almost completely depleted, the distance element 26 will prevent a contraction of a portion of the reservoir 11. On the other hand, if the initially provided container is empty, the distance element 26 will prevent the wall pieces 101, 102 from sticking together.

Fig. 10 (b) depicts a flexible container according to the present invention, wherein the insertion portion 2 is arranged in the center of the rectangular-shaped storage chamber 11. Again, the insertion portion 2 is held in place by a hoop-like positioning element 25, the hoop-like positioning element 25 being attached to the insertion portion 2 by four radial distance elements 26. In this variant, the access area 12 is located in the center of the storage compartment 11.

In fig. 11 and 12 a further advantageous variant of an insert part 2 for use with a flexible container 1 according to the invention is shown. In the depicted insert part 2, which insert part 2 has four oblong recesses as discharge channels 22, a circular sealing lip 27 is arranged around the access opening 121. The sealing lip 27 protrudes from the substantially flat surface 211 of the insertion part 2. In a flexible container having such an insertion portion, the access opening 121 on the upper wall sheet 101 includes a large circular hole 103, and the seal lip 27 protrudes through the circular hole 103. The sealing lip 27 is designed to interact with a sealing element 34 of the connecting device 3, providing a liquid-tight seal between the duct system 33 of the connecting device and the inner duct 23 of the insertion portion. The liquid-tight sealing between the wall sheet 101 and the insertion section 2 is a result of the external pressure of the pressure element 35 of the connecting device 3, which acts on the sealing lip 24 and the annular region around the access opening 121.

To ensure sterility, the access opening or even the entire access area may initially be covered with a removable cap or cover. In a preferred embodiment of the flexible container, with easily attached connection means, such a removable cap or cover will typically be provided on the fluid connector of the connection means.

An advantage of such embodiments of the insert and the flexible container is the fact that the liquid medicament inside the container will only be in contact with the inner surface of the wall sheet. This may be particularly advantageous if the wall sheet has a multilayer structure, and contact between the liquid medicament and one of the outer layers should be avoided.

The use of a flexible container 1 according to the invention with an insert part 2 as shown in fig. 11 is explained in more detail in fig. 12. The initially empty container 1 is secured in the connecting device 3 (fig. 12 (a)). The connecting means comprises a lower clamp portion 31 and an upper clamp portion 32, the lower clamp portion 31 having a recess in which the access area 12 of the container is located. The upper clamping portion 32 comprises a pressure element 35 in the form of a circular lip, pressing together the surface 211 of the insertion portion 2 and the upper wall sheet 101. The sealing lip 27 comes into close contact with the surface of the upper clamping portion 32 providing a fluid connection between the internal conduit 23 and the conduit system 33. In the embodiment shown, the upper clamping portion 32 does not comprise a special sealing element, but rather a flat contact area 34. This is for example possible if the polymeric material of the insertion part 2 and/or the holding part itself shows a certain elasticity. If the elasticity of the combination of the sealing lip 27 and the sealing element 34 is insufficient, a sealing ring can be arranged on the clamping portion 32.

After the container 1 has been fluidly connected to the connecting means 3, the container 1 is filled with its liquid content through the septum 331 using a syringe with a hollow needle. When the container 1 is safely filled, the hollow needle is retracted, so that the system comprising the container 1 and the connecting means 3 is ready for use (fig. 12 (b)). A pump device (not shown) can now suck up liquid from the container 1 via the duct system 33, 33'. The diaphragm 331 may also be used to remove air from the catheter system.

In fig. 13 and 14 another variant of the insert part 2 is shown, which is similar to fig. 11. In the embodiment described, the upper surface 211 of the male part 2 comprises a secondary, outer sealing lip 28 arranged in the periphery of the first, central sealing lip 27. When interacting with the flat surface pressure element 35 of the connecting device 3 (fig. 14), the secondary sealing lip 28 increases the local pressure between the upper surface 211 of the insertion portion 2 and the adjacent wall piece 101, improving the seal between the insertion portion 2 and the wall piece 101.

Fig. 15 discloses an embodiment of the male part 2 with a seal 27 manufactured by two-component injection moulding. Although the main body 21 of the insertion part 2 consists of a rigid material, the sealing lip 27 is made of a comparatively soft elastomeric material. When locked in the connecting device 3 (fig. 16), the elastic, elastomer sealing lip 27 establishes a fluid-tight connection of the access opening 121 with the duct system 33 of the upper clamping portion 32.

In all the embodiments of the flexible container according to the invention discussed so far, the insert part 2 and the adjacent wall sheet 101 are not bonded to each other. When a liquid-tight seal between the insertion part 2 and the wall sheet 101 is necessary, such as in the embodiments shown in fig. 11, 12, 13 and 14, this seal is provided merely as a temporary applied external pressure 35 on the two elements 211, 101. Alternatively, in all disclosed embodiments, the insertion part may be permanently connected to the wall sheet by heat sealing, ultrasonic welding, high frequency induction welding, gluing or any other suitable method. On the one hand, this variant of the invention requires additional steps during manufacture, but on the other hand, no pressure elements are required on the clamping portion of the connecting element 3.

In fig. 17 an example of a flexible container 1 according to the invention with a permanently sealed wall sheet 101 and an insertion part 2 is shown. The disclosed insert part 2 is similar to the one shown in fig. 14. However, since the surface 211 of the insertion part 2 is sealed to the wall sheet 101, no additional pressure element of the connection element is required.

The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and accompanying drawings. Accordingly, such modifications are intended to fall within the scope of the appended claims. In addition, throughout this specification, various references are cited, the disclosures of which are each incorporated by reference herein in their entirety.

List of reference numerals

1 Flexible Container

101. 102 wall sheet

103 round hole

11 storage volume

12 access area

121 Access opening

13 sealing lip

14 sealing area

15 longitudinal axis

16 neck, constriction

17 positioning element

2 insertion part

21 main body of the insertion part

211 upper surface

212 lower surface

22 discharge channel

221 exhaust channel network

222 projection

23 inner conduit

24-needle stopper

25 positioning element

26 distance element

27 sealing lip

28 Secondary sealing lip

3 connecting device

31 lower clamping part

32 upper clamping part

33. 33' catheter system

331 diaphragm

332 hollow needle

34 sealing element

35 a pressure element.

Claims (21)

1. A flexible container (1) for storing a liquid medicament, the flexible container consisting of two wall sheets (101, 102) of a flexible, liquid-tight material sealed along a circumferential sealing edge (13) and an insert part (2) arranged between the two wall sheets, the container (1) comprising a storage chamber (11) for the liquid medicament and an access opening (121) on one of the wall sheets (101), wherein the storage chamber (11) and the access opening (121) are in fluid connection, and the access opening (121) is designed to be fluidly connected to an external conduit system (33), and wherein the insertion part is locked between the two wall sheets with a form fit and fluidly connects (22, 23, 221) the storage chamber (11) and the access opening (121), characterized in that the periphery of the insertion portion is positively locked between two adjacent wall sheets (101, 102) and the sealing edge (13) of the wall sheet.

2. The flexible container according to claim 1, characterized in that the insert part (2) is arranged and positively locked in an access region (12) of the container (1), the access region (12) being separated from the storage chamber (11) by a neck (15) or constriction.

3. The flexible container according to claim 1 or 2, characterized by elements for positioning and/or fixing (17) the flexible container (1) in the connecting device (3).

4. The flexible container according to claim 3, characterized in that the element for positioning and/or fixing is two or more holes (17) and/or grooves arranged in the sealing area (14) of the container and/or in the area of the wall sheet (101, 102) outside the sealing area not belonging to the storage chamber (11).

5. The flexible container according to claim 1, characterized in that the access opening (121) comprises a hole (103) arranged in the wall sheet (101) adjacent to the insertion portion (2) and the insertion portion (2) comprises a sealing lip (27) arranged on an upper surface (211) of the insertion portion, wherein the sealing lip (27) protrudes through the hole (103) of the access opening (121).

6. Flexible container according to claim 5, characterized in that the positive locking of the insertion section (2) in the flexible container (1) is at least partly achieved by a sealing lip (27) of the hole (103) through the access opening (121).

7. The flexible container according to claim 3, characterized by a connection device (3) for use in an infusion pump device, the connection device (3) comprising two clamping portions (31, 32), the two clamping portions (31, 32) being adapted to positively and/or non-positively lock the flexible container (1) and to fluidly connect the access opening (121) of the flexible container (1) to a conduit system (33) of the connection device (3).

8. The flexible container according to claim 7, characterized in that the clamping portion (32) facing the access opening (121) comprises a sealing element (34), the sealing element (34) being adapted to fluidly connect the duct system (33) with the access opening (121) of the flexible container (1).

9. Flexible container according to claim 8, characterized in that the surface of the holding portion (31, 32) of the connecting device (3) is adapted to the outer shape of the flexible container (1).

10. The flexible container according to claim 9, characterized in that the connecting means (3) comprise elements for positioning and/or fixing the flexible container (1).

11. The flexible container according to claim 1, characterized in that the insert portion (2) comprises a substantially flat body (21) having a first, upper surface (211) and a second, lower surface (212), and an internal duct (23), the internal duct (23) being open towards the upper surface (211) and being fluidly connected to one or more discharge channels (22, 221) opening to the outer edge of the body (21).

12. The flexible container according to claim 11, characterized in that the one or more discharge channels (22, 221) are embodied as dimples arranged on the lower surface (212) and/or as tubular conduits arranged inside the body (21) of the insert portion (2).

13. The flexible container according to claim 12, characterized in that the insert part comprises one or more positioning elements (25) adapted to positively lock the insert part (2) in the flexible container (1).

14. The flexible container according to claim 13, characterized in that the insert part comprises a sealing lip (27) arranged on the upper surface (211) for sealingly connecting the inner conduit (23) with the outer conduit system (33).

15. The flexible container according to claim 14, characterized in that the insert part comprises a secondary sealing lip (28) arranged on the upper surface (211) for sealingly connecting the upper surface (211) with an adjacent wall sheet (101) of the flexible container (1).

16. The flexible container according to claim 3, characterized by elements for positioning and/or fixing (17) the flexible container (1) in the connection device (5) of the infusion pump device (2).

17. The flexible container according to claim 9, characterized in that the surface of the holding portion (31, 32) of the connecting device (3) is adapted to the outer shape of the access area (12) of the container (1).

18. Flexible container according to claim 10, characterized in that the connecting means (3) interact with elements for positioning and/or fixing (17) of the flexible container (1).

19. The flexible container according to claim 14, characterized in that the sealing lip (27) consists of a material having a higher elasticity than the material of the body (21) of the insert part.

20. A device for automated release of a liquid medicament comprising or incorporating at least one flexible container according to any one of claims 1 to 19.

21. An apparatus for the automated release of a liquid medicament according to claim 20, characterized in that it is an infusion pump apparatus.