Injection device with release liner and reinforcing sheet

Abstract

The present application relates to an injection device comprising a housing having an adhesive layer on at least one lateral surface of the housing, and a release liner (20) at least partially covering the adhesive layer. The release liner comprises a sheet of material having a first surface contacting the adhesive layer, and at least one aperture (32) defining a passage through the sheet of material. The release liner is covered by a reinforcing sheet (40) adhesively connected to a second surface of the sheet of material and covering the at least one aperture. The reinforcing sheet comprises at least one region forming an elongated recess (43) oriented towards the at least one aperture with respect to the release liner.

Description

Technical Field

[0001] This invention relates to an injection device having a release liner covering an adhesive layer disposed on a housing of the injection device. The release liner includes a reinforcing sheet that at least partially reinforces the release liner. The reinforcing sheet is configured to reduce the occurrence of wrinkles and creases when applied to the release liner. Background Technology

[0002] Injection devices are used to deliver liquid medications subcutaneously to a patient. Such devices are typically pen-shaped with a long axis and are referred to as injection pens. An injection pen includes a housing that holds the dose setting and delivery mechanism. The medication is preferably contained in a cartridge or pre-filled syringe. A cartridge holder is typically used to attach the cartridge to the pen's housing. The user sets the dose of the medication to be administered, which is then delivered from the cartridge. Such injection pens are intended for delivering individual injections and are not designed for continuous medication delivery. Before each use, a needle is attached to the injection pen and penetrates a septum attached to the cartridge.

[0003] Another type of injection device is an infusion device, which uses a drive mechanism and control mechanism to deliver medication from a cartridge. The control mechanism controls the advancement of a piston rod that abuts against a movable plunger present in the cartridge containing the medication. The medication is delivered to the patient via a fluid path and an external infusion kit including a needle for subcutaneous delivery. With such infusion devices, continuous and intermittent medication delivery profiles can be programmed.

[0004] Patch devices are examples of infusion devices that can be attached to a patient's skin. Such patch devices do not require an external infusion kit for delivery because the needle is contained directly within the patch device and can be inserted into the patient from there.

[0005] Injection equipment includes a dosage setting mechanism, a delivery mechanism, a needle insertion and retraction mechanism, or a needle shield protection system, which is connected to or can be connected to the delivery mechanism. The delivery mechanism may be driven by springs (compression springs, torsion springs, or leaf springs), electric motors, pressurized gas, or hydraulic systems.

[0006] Typically, injection devices include a power source such as a battery that supplies energy to the injection or infusion device to perform tasks such as drug delivery, establishing a connection between the fluid path and the cartridge, needle insertion, needle retraction, advancing and / or retracting the piston rod, signaling to the patient that drug administration is in progress and / or complete, signaling to the patient that the device can be removed, powering the processor unit within the device, or establishing a wireless connection for transmitting data to a remote device (e.g., a mobile phone). Typically, several operations need to be performed by the injection device in a certain sequence for proper operation. This sequence of operations can be performed manually by the patient or automatically by an electronic control unit.

[0007] For patch devices, a needle must first be inserted into the patient using a steel needle (also called a cannula) or a combination of a steel needle and a soft cannula. In the latter case, after insertion, the steel needle must be retracted to leave the soft cannula in the patient's subcutaneous tissue. Medication delivery follows the insertion of the steel needle or soft cannula into the patient's subcutaneous tissue. After medication delivery, and before the patch device can be removed from the body, the needle (soft or steel) is preferably retracted into the device, for example, inside its housing. Alternatively, the needle is not retracted, but a needle guard extends from the device housing to protect the needle tip and prevent accidental needlestick injuries.

[0008] The medication is preferably a liquid, produced under aseptic conditions, and enclosed in a container to maintain its sterility. Such a container can be a cartridge or ampoule as mentioned above, both preferably made of glass. Alternatively, a plastic container can be used. The container comprises a cylindrical body with two openings, one at the end of a neck portion and a second opening opposite the neck portion. The opening at the neck portion is typically closed by a permeable diaphragm attached to the neck portion using a crimping fitting. The opposite opening is closed by a plunger, and the medication is enclosed by the container between the diaphragm and the plunger. During medication delivery, the plunger is advanced within the container by a drive mechanism. The container is filled with the liquid medication on a fill-finish line, either by first inserting the plunger into the container and filling the medication via the neck portion, followed by closure using the diaphragm crimped to the neck portion, or by first attaching the diaphragm to the neck of the container and filling the medication from the opposite opening, and finally closing with the plunger. Fill-finishing is performed in an aseptic environment. The filled containers are typically visually inspected to ensure that there are no particles in the liquid medication.

[0009] The filled cartridge is assembled with an injection or infusion device, preferably a patch device, having a fluid path unit for establishing a connection between the needle and the container.

[0010] The fluid pathway unit includes a housing for internally containing the fluid pathway. The fluid pathway may include a needle capable of piercing a septum of the container, and a conduit for fluid delivery for connecting the needle to a hollow needle (which is a soft needle and / or a steel needle) intended to penetrate a patient's skin. Preferably, there is no connection between the container and the fluid pathway prior to drug delivery. The connection between them is preferably established prior to drug delivery by piercing the septum with the needle. The interior of the housing for the fluid pathway unit is sterilized during manufacturing and remains sterile prior to drug delivery. The fluid pathway and container may be assembled in a sterile environment, which can be cumbersome (e.g., considering visual inspection) and expensive, or it may be assembled in a non-sterile environment such as a cleanroom. The device comprising the fluid pathway and container may be contained in a sterile package prior to drug delivery, and the sterile package is removed prior to drug delivery.

[0011] Patch devices are typically attached to a patient's skin by means of an adhesive layer disposed on the patch device before use. The adhesive layer is thus protected by a release liner, which is removed only before the patch device is attached to the patient's skin. Typically, the release liner is attached to at least one sterile barrier membrane inside the patch device, such that the at least one sterile barrier membrane is removed simultaneously with the release liner. Removal of the release liner is performed by the patient by tearing the release liner off the patch device. To reinforce the release liner in certain areas, particularly in areas where it is attached to the sterile barrier membrane, the release liner may be provided with a reinforcing strip, which is adhesively attached to both the release liner and the sterile barrier membrane. The provision of such a reinforcing strip significantly reduces the occurrence of tearing of the release liner and detachment of the sterile barrier membrane from the release liner.

[0012] US2020 / 0086044 A1 discloses a patch pump that includes disposable and reusable parts, wherein the disposable parts include an adhesive surface for releasable attachment to a patient's skin. The adhesive surface is covered by a protective film that must be removed before attachment to the skin.

[0013] WO2019 / 175689 A1 discloses a patch pump capable of releasably attaching to a patient's skin, comprising an adhesive surface initially covered by a release liner. The release liner is reinforced by a reinforcing sheet or bonding patch adhesively attached to the outer surface of the release liner.

[0014] However, in certain areas of the patch assembly, the surface to which the reinforcing sheet is applied may not be completely flat, but may include raised areas, for example, due to the presence of components (such as the aforementioned sterile barrier membrane) protruding outward from the surface of the patch assembly or disposed on the release liner. The reinforcing sheet, adhesively applied to the release liner, may wrinkle or form creases in those areas. However, wrinkles or creases negatively affect the visual appearance of the patch assembly and may create the impression of an inferior or defective component. Summary of the Invention

[0015] Therefore, the object of the present invention is to create an injection device having a release liner reinforced by a reinforcing sheet that is adhesively attached to the release liner in a wrinkle-free and crease-free manner.

[0016] The solution of the present invention is specified by the features of claim 1. According to the invention, a pharmaceutical delivery device includes a housing having an adhesive layer on a bottom surface of the housing and a release liner at least partially covering the adhesive layer. The release liner includes a sheet of material having a first surface in contact with the adhesive layer and at least one orifice defining a passage through the sheet of material. The release liner is covered by a reinforcing sheet or bonding patch adhesively attached to a second surface of the sheet of material and optionally covering the at least one orifice. The reinforcing sheet includes at least one region forming a concave recess relative to the circumference of the release liner, such that the edge of the reinforcing sheet bends away from the circumference of the release liner in at least two segments, resulting in a region of sheet having a greater distance from the circumference of the release liner compared to adjacent regions. The at least one region is adapted such that the concave recess is oriented toward or at least partially disposed above the orifice of the release liner. “Above” should be understood as the reinforcing sheet covering at least a portion of the orifice when viewed from a direction perpendicular to the adhesive surface. In a preferred embodiment, the release liner is covered by only a single reinforcing sheet. The reinforcing sheet is a continuous, single-connected or 1-connected sheet of material without any holes.

[0017] By providing a concave recess near the orifice, the slight elevation of the reinforcing sheet caused by the element slightly protruding through the orifice is mitigated in the recessed area, and the reinforcing sheet remains free of any wrinkles or folds. The element may include a strip fed through the orifice and attached to the release liner near the orifice. The smooth surface of the reinforcing sheet enhances the visual appearance of the injection device as perceived by the user.

[0018] The term "pharmaceutical preparation" includes any flowable medical formulation suitable for controlled administration via a device such as, for example, a cannula or a hollow needle. A pharmaceutical preparation can be a liquid, solution, gel, or fine suspension containing one or more medically active compounds. A pharmaceutical preparation can be a composition containing a single active compound, or a premixed or co-formulated composition containing more than one active compound in a single container. Pharmaceutical preparations can include drugs, such as peptides (e.g., insulin, insulin-containing drugs, GLP-1-containing drugs, or derivatives or similar preparations), proteins and hormones, active compounds derived from or obtained from biological sources, hormone- or gene-based active compounds, nutritional formulations, enzymes, and other substances in solid (suspension) or liquid form, and may also include polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or portions of antibodies, as well as base substances, auxiliary substances, and carrier substances.

[0019] The distal end of an injection device is the end that faces the patient during drug injection. Conversely, the proximal end of the injection device is the end that faces away from the patient during drug injection. This also applies to the term "distal orientation." 1 "Proximal direction" refers to the direction towards the patient during drug injection and the direction away from the patient during drug injection, respectively.

[0020] Since the injection device includes an adhesive layer on at least one side surface of the housing, the injection device according to the invention is primarily constructed as a patch device, which can be adhered to the patient's skin by means of the adhesive layer.

[0021] The housing can have any suitable shape, but is preferably generally cuboid, and most preferably has rounded corners and / or rounded edges. The housing is preferably made of a polymer material. The housing is preferably made of at least two assembled parts. The housing surrounds an open space.

[0022] The adhesive layer is preferably located on the main bottom surface of the housing. Preferably, the adhesive layer covers at least 50% of the surface area of ​​at least one side surface, more preferably at least 70%. The adhesive layer may include a skin adhesive material for adhesion to the skin. Thus, the injection device can be releasably attached to the patient's skin by means of the adhesive layer. This allows the injection device to be temporarily attached to the injection site on the patient, i.e., for several minutes to several hours or even several days. The adhesive layer is preferably applied directly to at least one surface of the housing. Alternatively, a circuit layer including a conductive sensor may be located between at least one surface of the housing and the adhesive layer. The conductive sensor is preferably a capacitive sensor. In this case, the circuit layer is preferably attached to at least one surface of the housing by means of a second adhesive layer, and the adhesive layer is subsequently applied to the circuit layer.

[0023] A release liner is disposed on the adhesive layer and contacts the first surface. Thus, the adhesive layer is at least partially covered by the release liner. Preferably, the release liner is configured to completely cover the adhesive layer. This protects the adhesive layer from premature adhesion to the surface before the use of the injection device (i.e., before attaching the injection device to the injection site on the patient's skin). Furthermore, the release liner protects the adhesive layer from dust, which can adhere to the adhesive layer and thus reduce its adhesive strength. The release liner is preferably made of at least one sheet of material, preferably of at least one sheet of polymer material. The release liner may include a conductive layer, such as a silver ink layer or a carbon black layer, which covers and is part of the signal sensor (e.g., a conductive sensor with a circuit layer as described above).

[0024] At least one opening in the material sheet passing through the release liner can have any suitable shape and size. Preferably, the at least one opening is circular, oval, rectangular polygonal, or stadium-shaped. The release liner may include only one opening, but preferably includes more than one opening, such as two, three, four, five, or more openings. At least one opening may be located within the surface of the release liner, thus forming a hole through the material sheet that is completely surrounded by the material sheet, or it may be located on the edge of the material sheet, thereby forming a notch along the edge of the material sheet of the release liner.

[0025] The reinforcing sheet is preferably adhesively attached to a second surface of the material sheet of the release liner, the second surface being positioned opposite the first surface. To adhesively attach the reinforcing sheet to the release liner, the reinforcing sheet preferably includes an adhesive on its inner side oriented toward the release liner (i.e., the side intended to be disposed on the release liner). Alternatively, the reinforcing sheet may be attached to the release liner by any other suitable means, such as welding, riveting, etc.

[0026] The reinforcing sheet may only partially cover the release liner, specifically, only in the area including at least one orifice. However, preferably, the reinforcing sheet substantially covers the entire release liner, i.e., covers at least 70% or more of it. In a preferred embodiment, the reinforcing sheet completely covers the release liner.

[0027] The reinforcing sheet is preferably made of a polymer material, paper, or woven or nonwoven textile material. If the reinforcing sheet is made of a polymer material, the polymer material is preferably or includes polyethylene terephthalate, polybutylene terephthalate, polyester, or polyolefin, such as high-density polyethylene or polypropylene.

[0028] The reinforcing sheet serves as a reinforcement for the release liner to prevent any tearing of the release liner when it is removed from the adhesive layer. Furthermore, the reinforcing sheet can be used to securely attach other components, such as a sterile barrier foil, to the release liner, as any additional components can be connected between the release liner and the reinforcing sheet, thereby ensuring reliable removal of any additional components from the injection device when the release liner is removed. Finally, the reinforcing sheet is provided to close at least one orifice, thereby providing a sterile barrier that prevents contamination of the at least one orifice and any components inserted through it.

[0029] Preferably, the cartridge holder is disposed within an open space of the housing. The cartridge holder is preferably configured to hold the cartridge. The cartridge preferably includes a container containing the medication. The container is preferably made of glass (such as borosilicate glass) or a polymer material. The container includes a cylindrical body with two openings, one at the end of a neck portion and a second opening opposite the neck portion. The opening at the neck portion is preferably closed by a permeable diaphragm, which is preferably attached to the neck portion by a crimp. A sterile barrier foil may be disposed on the diaphragm to prevent any contamination of the diaphragm. The opposing openings of the cylindrical body are preferably closed by a plunger movable in the dispensing direction within the cylindrical body. The medication is surrounded by a container between the diaphragm and the plunger. The cartridge preferably also includes a protective outer shell for the container and is provided with means for releasably connecting the cartridge to the cartridge holder.

[0030] Within the open space, the housing of the injection device preferably includes a fluid path. The fluid path preferably includes a needle for penetrating a diaphragm of a cartridge held in a cartridge holder, and a tube connected to the needle at its first end. The second end of the tube may be connected to a hollow needle or to a connector for connecting the tube to a cannula. Thus, the fluid path allows a fluid connection to be established between the container and the hollow needle or cannula before injection of the drug via penetration of the diaphragm by the needle. Therefore, the needle is preferably positioned close to the cartridge holder within the open space of the housing. Preferably, the fluid path is within a receiving portion of the housing. The receiving portion may be defined by wall elements or by the inner housing and the remainder of the open space. The inner housing is preferably a separate unit comprising the fluid path inserted into the open space of the housing during the manufacture of the injection device.

[0031] The receiving portion preferably includes a first opening positioned toward a cartridge holder configured such that when the cartridge is held within the cartridge holder, the diaphragm faces or abuts the first opening. The first opening is preferably covered by a sterile barrier foil to prevent any contamination of the fluid path prior to use of the injection device (i.e., prior to injection of the drug). The fluid path is preferably sterilized when the sterile barrier foil is attached to the first opening. For example, the sterile barrier foil is made of a porous membrane such as Tyvek, and the receiving portion is sterilized using gas plasma or ethylene oxide gas sterilization. Alternatively, radiation sterilization techniques such as gamma radiation, electron beams, or X-rays can be used.

[0032] The needle is preferably linearly movable toward the diaphragm of the cartridge container held in the cartridge holder to pierce the diaphragm and establish a fluid connection between the container and the fluid path. The needle may be manually moved by a patient, for example by means of a slider or rotary knob kinetically coupled to the needle. However, preferably, the needle is movable toward the diaphragm by means of a needle actuator. The needle actuator may include a pre-tensioned spring, such as a torsion spring, a coil spring, or at least one pre-tensioned elastic element. Alternatively, the needle actuator may include an electromechanical actuator, a pneumatic or hydraulic actuator, etc.

[0033] The housing preferably also includes a drive mechanism for moving the piston of the cartridge container and an electronic control unit for controlling the device. The drive mechanism preferably includes at least one electric motor that preferably linearly drives the drive element by means of a transmission. The drive element is thus configured to abut against the piston to move the piston in the dispensing direction within the cartridge body to expel the medication from a first opening in the cartridge body.

[0034] The electronic control unit preferably includes at least one microcontroller or processor, a printed circuit board, and an electrical power source such as a battery. The electronic control unit is configured to control the drive element to inject the correct amount of medication according to a pre-programmed or programmable dosing regimen.

[0035] The recess preferably has an elongated shape that tapers in the direction from the boundary of the sheet toward at least one orifice in the release liner. The width of the recess continuously decreases near the orifice.

[0036] The recess allows for the reduction of any wrinkles or creases when attaching the reinforcing sheet to the release liner, as any misalignment of the reinforcing sheet can be compensated for by stretching the reinforcing sheet by moving the edges of the elongated recess closer together.

[0037] Preferably, at least one elongated recess has a trapezoidal shape. Alternatively, at least one elongated recess may have any other suitable shape, such as a triangle, rectangle, rhombus, oval, or polygon.

[0038] Preferably, the injection device includes at least one membrane or strip connected to a sterile barrier foil located within the housing, the at least one membrane passing through the at least one orifice and connected to the inside of a reinforcing sheet oriented toward the release liner.

[0039] With this configuration, at least one membrane is securely attached to the reinforcing sheet such that once the release liner is removed from the housing, at least one membrane is carried away and thus removed by the removal movement. This configuration allows for the removal of at least one barrier foil simultaneously with the removal of the release liner when at least one membrane is attached to the sterile barrier foil. Preferably, at least one membrane is attached to the reinforcing sheet by means of an adhesive (preferably the same adhesive used to attach the reinforcing sheet to the release liner).

[0040] Preferably, at least one membrane or strip is attached to the second side of the release liner with a first membrane surface and to the inside of the reinforcing sheet with a second membrane surface, so as to be sandwiched between the release liner and the reinforcing sheet. Providing the reinforcing sheet on the release liner thereby ensures that at least one membrane does not break off from or tear from the release liner when the release liner is removed.

[0041] At least one orifice is preferably configured as a notch or cut on the side edge of the release liner. This allows the membrane or strip attached to the sterile barrier foil to be introduced into the orifice by laterally inserting or displacing the membrane into the notch. In this configuration, the recess in the reinforcing sheet preferably at least partially coincides with the notch.

[0042] Preferably, a first membrane connected to the first sterile barrier foil is inserted through the orifice, the first membrane is at least connected to the second side of the release liner, the first membrane is further inserted through the passage of the housing, and the first sterile barrier foil closes at least one opening of the fluid path located within the housing.

[0043] The passage provides an opening through the sidewall of the housing, through which the first membrane or any other element (such as, for example, a second membrane) can be inserted. In this way, the first membrane can thus be guided from the open space surrounded by the housing to the outside of the housing.

[0044] The fluid path is preferably constructed as described above, including a needle and an opening, whereby the first sterile barrier foil is attached to the opening to seal it. A connection is made possible by passing the membrane through a passage in the housing and through at least one orifice of the release liner, allowing the first sterile barrier foil to be removed from the opening simultaneously with the removal of the release liner. The passage is preferably located on the housing to substantially coincide with at least one orifice. Preferably, the first membrane is further connected to the inside of a reinforcing sheet.

[0045] The first membrane is preferably made of the same material as the first sterile barrier foil. More preferably, the first membrane and the first sterile barrier foil are an integral material, with the first sterile barrier foil forming part of an integral material that has been sterilized and seals the sterilized fluid path. In this case, the first membrane is the remaining portion of the integral material that does not seal the sterilized fluid path. Preferably, the first sterile barrier foil and preferably the first membrane are made of several nonwoven porous polyethylene, polypropylene, or paper (cellulose) films laminated together. More preferably, the first sterile barrier foil and preferably the first membrane are made of polyethylene fleece such as Tyvek® (e.g., manufactured by DuPont de Nemours). Preferably, the first sterile barrier foil and preferably the first membrane are coated to enhance or control their adhesive properties.

[0046] Alternatively, the first membrane and the first sterile barrier foil may be made of different materials, i.e., the first membrane and the first sterile barrier foil are components of different materials, which are joined together, for example, by means of adhesives, by means of welding, etc.

[0047] To protect the fluid path from contamination, the first sterile barrier foil is preferably attached circumferentially around the opening in a releasable manner, for example by means of an adhesive.

[0048] Preferably, the injection device includes a container held within a housing containing a drug and including at least one opening closed by a diaphragm, a second sterile barrier foil disposed on the diaphragm, and the injection device further includes a second membrane connected to the second sterile barrier foil, the second membrane being inserted through at least one orifice of a release liner and through a passage in the housing, the second membrane being connected to at least a second side of the release liner.

[0049] With this configuration, the second sterile barrier foil protecting the septum from contamination can be removed simultaneously with the removal of the release liner. The container is preferably arranged within the cartridge as described above.

[0050] The second membrane is preferably made of the same material as the second sterile barrier foil. More preferably, the second membrane and the second sterile barrier foil are an integral material, with the second sterile barrier foil forming part of the integral material, which has been sterilized and connected to the sterilized diaphragm. In this case, the second membrane is the remaining portion of the integral material not connected to the diaphragm. Preferably, the second sterile barrier foil and preferably the second membrane are made of polyethylene fleece such as Tyvek® (e.g., manufactured by DuPont deNemours). Alternatively, the second membrane and the second sterile barrier foil may be made of different materials, i.e., the second membrane and the second sterile barrier foil are components of different materials, which are joined, for example, by means of adhesives, by means of welding, etc.

[0051] Preferably, if the injection device includes a first membrane and a second membrane, the two membranes are inserted through the same orifice of the release liner and through the same passage of the housing. Alternatively, however, the first membrane is inserted through the first orifice of the release liner and the first passage of the housing, while the second membrane is inserted through the second orifice of the release liner and the second passage of the housing.

[0052] Preferably, the housing is configured to guide the first membrane and / or the second membrane within its open space. For example, the housing may include passageways for the first membrane and / or the second membrane, defined by wall elements, which preferably have smooth or rounded edges, protrusions, or pins present in the open space of the housing, etc. This allows for the smooth removal of the first membrane and / or the second membrane, as well as the first sterile barrier foil and / or the second sterile barrier foil respectively connected to them.

[0053] Preferably, the injection device includes a passage for a hollow needle configured to move from a first position to a second position, in the first position the tip of the hollow needle is located inside the housing and in the second position the tip of the hollow needle is located outside the housing, the passage being covered by a third sterile barrier foil, wherein at least one orifice of a release liner is located on the opening, and the third sterile barrier foil is adhesively attached to the inside of a reinforcing sheet.

[0054] When the third sterile barrier foil is attached to the reinforcing sheet, the third sterile barrier foil is removed at the same time as the release liner and the reinforcing sheet are removed, thus opening the passage.

[0055] Therefore, once the injection device is attached to the patient by means of an adhesive layer, the hollow needle can move linearly through the opening to pierce the patient before the medication is injected. For linear movement of the hollow needle, the injection device preferably includes a needle insertion and retraction mechanism kinetically coupled to the hollow needle. The needle insertion and retraction mechanism may include at least one pre-tensioned spring, such as a torsion spring, a coil spring, or at least one pre-tensioned elastic element. Alternatively, the needle insertion and retraction mechanism may include an electromechanical actuator, a pneumatic or hydraulic actuator, etc.

[0056] Preferably, the injection device includes a reusable drive module that is releasably coupled to the housing at a connection interface of the housing, the connection interface including at least one first mechanical connection device that is releasably connected to at least one second mechanical connection device of the reusable drive module.

[0057] In this embodiment, the drive mechanism for moving the piston of the cartridge container and the electronic control unit for controlling the injection device are located in a reusable drive module. Therefore, the reusable drive module can be reused by detaching from the housing and attaching it to a new housing. Thus, the housing itself, with any components located therein or on it, is constructed as a disposable module. Since the drive mechanism and electronic control unit do not need to be discarded after all medication has been dispensed from the container, and the reusable drive module can be simply attached to a new housing (i.e., a new disposable module), the amount of waste and the cost to patients are significantly reduced. Furthermore, the environmental impact is also greatly reduced because electronic and mechanical parts are not discarded each time the container is emptied.

[0058] The connection interface is preferably located on the side surface of the housing (i.e., not its main surface). The reusable drive module preferably includes a second housing. The second housing is preferably sized and shaped to match the size and shape of the housing, so that the injection device has an attractive shape when the reusable drive module is connected to the housing.

[0059] Preferably, the reusable drive module is equipped with a component that is combined with the disposable module and can be coupled or connected to the reusable module to enable the metering and dispensing of the medication contained in the container. Preferably, the reusable drive module includes a drive element, such as a piston rod, coupled to the drive mechanism and movable outside the second housing or protruding from the second housing to achieve plunger contact with the container. Furthermore, the reusable drive module preferably includes at least one electrical contact, such as a pin, spring plate, etc., which engages with an electrical contact element arranged on a connection interface of the housing, allowing electrical energy (e.g., from a battery in the reusable drive module) to be transferred to components within the open space of the housing, such as, for example, a needle extension and retraction mechanism.

[0060] Reusable drive modules should preferably be designed so that they can be sequentially connected to multiple disposable modules.

[0061] Preferably, the reusable drive module includes volatile or non-volatile memory elements and / or data transmission devices for exchanging data with external control elements, such as mobile phones, computers, or pump control applications running on mobile devices.

[0062] The first and second mechanical connecting devices are preferably configured as bayonet couplings. Alternatively, the first and second mechanical connecting devices may be in the form of a releasable snap-fit ​​connection, a force-fit connection (e.g., threaded hole and wing screw), or any other suitable type.

[0063] Preferably, the first and second mechanical connection devices are configured such that the patient must properly align the two components (disposable module and reusable module) relative to each other to establish a connection between them. In the case of a bayonet connection, the patient must thus rotate or engage the two modules with each other and subsequently twist them relative to each other by a predetermined angle until the two modules lock into each other. The first and second mechanical connection devices may, for example, be configured to automatically lock or engage with each other after relative rotation has been performed. Preferably, this also establishes an electrical connection between the modules. Preferably, the first and second mechanical connection devices are configured such that the two modules are pulled together when a connection is established between them. More preferably, the first and second mechanical connection devices are designed such that a backlash-free connection can be established by the patient with as little force as possible.

[0064] Preferably, the electrical connection between the disposable module and the reusable drive module is established only when the two modules are correctly connected to each other. For example, the electrical contacts on the reusable drive module and the disposable module may be sized such that they do not yet provide an electrical connection, that is, for example, such that a gap remains between them before the disposable module and the reusable drive module are sufficiently pulled together or, for example, threaded together to establish a secure connection.

[0065] For example, the injection device according to this embodiment can be constructed as disclosed in US 2020 / 0086044 A1.

[0066] Preferably, the connection interface includes at least one interface opening closed by a fourth sterile barrier foil connected to a fourth membrane inserted through a third orifice of the release liner.

[0067] Therefore, at least one interface opening can be aseptically closed by means of a fourth sterile barrier foil prior to drug injection. The fourth sterile barrier foil can be removed together with the release liner, as the fourth sterile barrier foil is attached to the release liner by means of a fourth membrane.

[0068] Other advantageous embodiments and combinations of features can be obtained from the following detailed description and the entire claim. Attached Figure Description

[0069] The accompanying drawings are for illustrative purposes, in which: Figure 1 A first exemplary embodiment of the injection device is shown; Figure 2 Show Figure 1 An exploded view of the injection device shown; Figure 3 An embodiment of a reinforcing sheet for use with an injection device according to the invention is shown; Figure 4 A schematic representation of another embodiment of the injection device according to the invention, with a reusable drive module, is shown; Figure 5 An embodiment of a cartridge that can be used with an injection device according to the invention is shown; Figure 6 Showing according to Figure 1 The longitudinal section of the injection equipment; Figures 7 to 10 As shown Figure 1 The final components of the injection device shown.

[0070] In the diagram, the same parts are given the same reference labels. Detailed Implementation

[0071] Figure 1 A first exemplary embodiment of the injection device 1 is shown. The injection device 1 includes a housing 2 surrounding an open space. It includes a cylindrical body 6 (see [link to previous embodiment]). Figure 5 and Figure 6 The cartridge 9 of the container is inserted into the housing 2, and the cartridge 6 contains the medicine. An adhesive layer 21 is arranged on the main bottom side of the housing 2 (see...). Figure 2 The injection device 1 can be removably attached to the skin of a patient (not shown) by means of an adhesive layer 21. The adhesive layer 21 is protected by a release liner 20 disposed thereon. In the illustrated embodiment, the release liner 20 covers the entire surface of the adhesive layer 21. In the illustrated embodiment, the release liner 20 protrudes from the housing 2 on one side to facilitate removal of the release liner 20 from the adhesive layer 21. Furthermore, in the area protruding from the housing 2, the release liner 20 includes a cutout 29 that allows the patient to more easily grasp the release liner 20. The release liner 20 includes a first membrane 11 and a second membrane 5 (see...). Figure 10 The first orifice 28 (see) Figure 2 The first membrane 5 and the second membrane 11 are bent and attached to the release liner 20. A first orifice 28 is configured as a notch at the edge of the release liner 20. Furthermore, the release liner 20 includes a second orifice 32, which is circular in the illustrated embodiment. A third sterile barrier foil 33 is disposed within the second orifice 32.

[0072] The reinforcing sheet 40 is attached to the release liner 20 to at least partially cover the release liner 20. Preferably, the reinforcing sheet 40 is adhesively attached to the release liner 20.

[0073] In addition, the injection device 1 includes a hollow needle (not shown) arranged within an open space of the housing 2 and movable from a first position to a second position. In the first position, the tip of the hollow needle is located inside the open space, and in the second position, the tip of the hollow needle protrudes from the housing 2. The hollow needle is arranged within the open space of the housing such that the tip of the needle is movable through a second passage 16 of the housing 2 (see...). Figure 2 The second passage 16 is arranged below the second orifice 32 of the release liner 20. For movement of the hollow needle, the injection device 1 includes a needle insertion and retraction mechanism (not shown). Thus, when the injection device 1 is attached to the patient's skin by means of the adhesive layer 21, the hollow needle can be moved from a first position to a second position for insertion into the patient. Furthermore, the injection device 1 includes a drive mechanism (not shown) to move the plunger 26 within the barrel 6 for movement via a fluid path (see...). Figure 6 The agent contained in the cylinder 6 is discharged into the hollow needle. Finally, the injection device 1 also includes an electronic control unit (not shown) arranged in the open space of the housing 2, which allows control of the drive mechanism and the needle insertion and retraction device.

[0074] Figure 2 Show Figure 1 The figure shows an exploded view of the injection device 1. In this figure, it can be seen that the release liner 20 is arranged on the adhesive layer 21 of the housing 2 such that the first orifice 28 coincides with the first passage 24 of the housing 2, and the second orifice 32 coincides with the second passage 16 of the housing 2.

[0075] Figure 3 An embodiment of a reinforcing sheet 40 for use with the injection device 1 according to the invention is shown. In this embodiment, the reinforcing sheet 40 includes a longitudinal recess 43 extending from the circumference of the sheet toward the orifice 32. The longitudinal recess 43 shown has a generally trapezoidal shape. The provision of the longitudinal recess 43 allows for further reduction of wrinkles or creases in the reinforcing sheet 40 when it is attached to the release liner 20.

[0076] Figure 5 An embodiment of a cartridge 9 for use with an injection device 1 according to the invention is shown. The cartridge 9 includes a body 6, which is preferably made of glass or optionally of a polymeric material such as polypropylene or a cyclic olefin polymer (or copolymer). The body 6 is preferably cylindrical and has a diaphragm (see [link to diaphragm description]). Figure 6The diaphragm has a closed, narrow neck 7, and is connected to the cartridge 9 using a crimping member 8. The crimping member 8 has an opening surrounding the diaphragm. A second sterile barrier membrane 4 is connected to the crimping member 8 in front of the diaphragm to protect the diaphragm from any contamination. The second sterile barrier membrane 4 is connected to a flexible second membrane 5. In the illustrated embodiment, the second sterile barrier membrane 4 and the second membrane 5 are made of a single piece of material, with the second sterile barrier membrane 4 constituting the sterile portion of the single piece of material. The second membrane 5 extends outward from the crimping member 8 and can be used to attach to the release liner 20 of the injection device 1, for example, to... Figure 1 An embodiment of the injection device 1. The cylinder 6 is filled with a drug to be administered to a patient by means of the injection device 1.

[0077] Preferably, the second sterile barrier membrane 4 is a porous membrane that allows gas sterilization, such as gas plasma (hydrogen peroxide) or ethylene oxide sterilization (ETO), to sterilize the diaphragm of the cartridge.

[0078] Figure 6 Showing according to Figure 1 The longitudinal section of injection device 1. For example, according to Figure 5 The cartridge 9 is inserted into the housing 2 of the injection device 1. The injection device 1 can be attached to the patient's skin using an adhesive layer 21 covered by a release liner 20. In the illustrated embodiment, a plunger 26 is movably arranged within the cartridge body 6. The plunger 26 is movable toward a diaphragm 27 to expel medication filled into the cartridge body 6 and held between the plunger 26 and the diaphragm 27. The housing 2 surrounds both the cartridge 9 and the outer shell 13 for a fluid path. The fluid path includes a needle 14 aligned parallel to the longitudinal axis of the cartridge 9, and an opening 25 disposed between the needle 14 and the cartridge 9. The opening 25 is closed by means of a first sterile barrier membrane 12. The first sterile barrier membrane protects the needle 14 from any contamination before the medication is administered by means of the injection device 1. Once the cartridge is inserted into the housing 2 of the injection device, the second sterile barrier membrane 4 and the first sterile barrier membrane 12 are arranged close to each other when the second sterile barrier membrane 4 is attached to the crimping member 8 and disposed on the diaphragm 27.

[0079] The cartridge 9 is positioned within a cartridge holder 15, which is arranged within a housing 2, i.e., within an open space surrounded by the housing 2. The cartridge 9 is axially fixed within the housing 2 and biased toward the outer casing 13 of the fluid path using a ratchet system. The ratchet system includes a ratchet member 18 guided on the inner wall of the housing 2. The ratchet member 18 is slidable along the longitudinal axis of the housing 2 after the cartridge 9 has been inserted. The teeth of the ratchet member 18 thereby engage the teeth of a mating ratchet member 19, which is axially fixed relative to the housing 2. The ratchet member 18 engages the proximal edge of the cartridge body 6 of the cartridge 9, thereby enabling axial fixation of the cartridge 9 within the housing 2 and biasing of the cartridge 9 toward the outer casing 13 of the fluid path. Alternatively, and instead of the ratchet member 18, the cartridge 9 may also be secured to a cover of the closed housing 2 using a ridge or fins. During the process of sealing the housing 2 with the help of the cap, the slit or fin plastically deforms on the proximal edge of the cartridge, thereby securing the cartridge 9 inside the housing 2.

[0080] The second sterile barrier membrane 4 is attached to the crimping member 8 using a first component 22. The first component 22 may be, for example, an adhesive or double-sided adhesive tape. Optionally, the first component 22 may be a resilient member such as an O-ring, which is compressed once the cartridge 9 is secured using a ratchet system. The second sterile barrier membrane 4 may also be directly heat-welded to the distal end surface of the crimping member 8. The second sterile barrier membrane 4 is attached to the crimping member in such a way that this connection can be released by applying force to the end of the second membrane 5 to peel the second sterile barrier membrane 4 from the crimping member 8.

[0081] An opening 25 in the fluid path allows the needle 14 to be at least partially removed from the housing 13 to penetrate the diaphragm 27. The movement of the needle 14 is achieved by a needle actuator (not shown) arranged in an open space within the housing. The opening 25 is covered by a first sterile barrier membrane 12, which is itself attached to a first membrane 11. The first sterile barrier membrane 12 is attached to the wall of the housing 13 and covers the opening 25, thereby preventing contamination of the fluid path, particularly the needle 14. Preferably, the first barrier membrane 12 is a porous membrane, which allows gaseous sterilization, such as gas plasma (hydrogen peroxide) or ethylene oxide sterilization (ETO), to sterilize the fluid path. The first sterile barrier membrane 12 is attached to the housing 13 using a second member 23. The second member 23 may be, for example, an adhesive or double-sided adhesive tape. Optionally, the second member 23 may be a resilient member, such as an O-ring, which can be compressed once the cartridge 9 is secured within the housing 2 using a ratchet system. Alternatively, the first sterile barrier membrane 12 can be directly heat-welded to the wall of the housing 13 in the area of ​​the opening 25. The first sterile barrier membrane 12 is attached to the housing 13 such that the connection can be released by applying force to the end of the first membrane 11 to peel the first sterile barrier membrane 12 from the housing 13, thereby opening the opening 25 for the needle 14 to move through.

[0082] The first membrane 11 and the second membrane 5 are guided through the passage 24 of the housing 2, such that the ends of the first membrane 11 and the second membrane 5 can be guided through the orifice 28 in the release liner 20. The ends of the first membrane 11 and the second membrane 5 are connected to the second surface of the release liner 20. A reinforcing sheet 40 is attached to the second side of the release liner 20 and covers the first membrane 11 and the second membrane 5.

[0083] By attaching the first membrane 11 and the second membrane 5 to the release liner 20, both membranes 5 and 11 are removed from the housing 2 when the release liner 20 is ripped off from the adhesive layer 21. When the first sterile barrier membrane 12 and the second sterile barrier membrane 4 are respectively attached to the first membrane 11 and the second membrane 5, the first sterile barrier membrane 12 and the second sterile barrier membrane 4 are removed from the opening 25 and the crimping member 3 respectively when the release liner 20 is removed from the adhesive layer 21. Optionally, after removing the first sterile barrier membrane 12 and the second sterile barrier membrane 4, any gaps that may exist between the diaphragm 27 and the housing 13 may be closed due to the resilience of the connecting members 22 and 23 and / or by means of a ratchet system.

[0084] Figures 7 to 10 As shown Figure 1 The final component of the injection device 1 shown is shown. The injection device 1 is shown inverted, with a release liner 20 covering the adhesive layer 21. The release liner 20 has a cutout 29 that functions as a handle to facilitate removal of the release liner 20. The release liner 20 has a first orifice 28 in the form of a recess located at the edge of the release liner 20 to facilitate insertion of the first membrane 11 from the side of the housing 2. A second side of the release liner 20, i.e., the side that does not contact the adhesive layer 21, includes a first adhesive point 30 and a second adhesive point 31. The adhesive points 30 and 31 may be a piece of adhesive tape.

[0085] like Figure 8 As shown, the end of the first membrane 11 is attached to the second side of the release liner 20 using a second adhesive point 31. This causes the first membrane 11 to bend around the edge of the first passage 26. Alternatively, the second adhesive point 31 may be present at the end of the first membrane 11. Other attachment methods for the end of the first membrane 11 include thermal welding or ultrasonic welding. The surfaces of the release liner 20 and the first membrane 11 that need to be connected to each other may be roughened, etched, sandblasted, heat-treated, or plasma-treated to enhance the adhesive bond between them.

[0086] Once the end of the first membrane 11 has been connected to the release liner 20, the cartridge 9 is laterally inserted into the housing 2 and connected to the cartridge holder 15, as shown. Figure 9 As shown in the diagram. During insertion of the cartridge 9, the end of the second membrane 5 is guided into the concave first orifice 28, and the first membrane 11 and the second membrane 5 can be arranged parallel to each other and in contact with each other.

[0087] The end of the second membrane 5 is attached to the second side of the release liner 20 using the first adhesive point 30, such as Figure 10 As shown in the diagram. The other options disclosed above for attaching the first film 11 to the second adhesive point 31 are also applicable to the attachment of the second film 5 to the first adhesive point 30. Figures 7 to 10 The order disclosed in the paper can also be reversed, i.e., the cartridge 9 can be inserted and the second membrane 5 can be attached to the release liner 20, and then the first membrane 11 can be attached to the release liner.

[0088] The release liner 20 includes a second orifice 32 surrounding a third sterile barrier membrane 33. The third sterile barrier membrane 33 is removably connected to the housing 2 of the injection device 1. The third sterile barrier membrane 33 covers a second passage 16 of the housing 2, which is designed to allow a hollow needle to move from a first position to a second position, in which the tip of the hollow needle is within an open space of the housing 2, and in the second position, the tip of the hollow needle protrudes from the second passage 16 for insertion into the patient. The hollow needle preferably moves perpendicular to the plane of the release liner 20. The third sterile barrier membrane 33 is preferably made of the same material as the first sterile barrier membrane 4 and the second sterile barrier membrane 12, and allows for gas sterilization. The release liner 20 is preferably not directly connected to the third sterile barrier membrane 33, but rather surrounds the third sterile barrier membrane 33.

[0089] The reinforcing sheet 40 is attached to the release liner 20, thereby covering at least the end of the first membrane 1, the end of the second membrane 5, the third sterile barrier membrane 33, and the orifices 28, 32 of the release liner 20. The reinforcing sheet 40 is preferably adhesively attached to the second side of the release liner 20, the first membrane 11, the second membrane 5, and the third sterile barrier membrane 33. When the first membrane 11 and the second membrane 5 are pulled out of the housing 2 (thus releasing the connection between the second sterile barrier membrane 4 and the septum 27, and the connection between the first sterile barrier membrane 12 and the opening 25) and the third sterile barrier membrane 33 is removed from the housing 2, the reinforcing sheet 40 reinforces the release liner 20, thereby preventing mechanical damage to the release liner 20 due to stress. The final assembly of the injection device 1 and the reinforcing sheet is... Figure 1 As shown in the image.

[0090] Figure 4An alternative embodiment of an injection device 1 according to the invention is schematically shown. In this embodiment, the injection device 1 includes a housing 2 and a reusable drive module 50, which can be releasably coupled to the housing 2. The housing 2 may also be referred to as a disposable module because after the medication has been fully dispensed from the container, the housing 2 can be detached from the reusable drive module 50, and the reusable drive module 50 can then be coupled to a new housing 2 (i.e., a new disposable module). The housing 2 includes a coupling interface 49 that allows for releasable coupling of the housing 2 to the reusable drive module 50. To enable this coupling, the coupling interface 49 includes two first mechanical coupling elements 51.1, 51.2, which are configured as slots in the illustrated embodiment. The reusable drive module includes a mating second mechanical coupling element, which is configured as such... Figure 4 The perspective view shown is not visible. Furthermore, the connection interface 49 includes an interface opening 48 through which components of the reusable drive module 50, such as, for example, the piston rod of a drive mechanism, can be inserted into the open space of the housing 2. The interface opening 48 is closed by means of a fourth sterile barrier membrane 45 to protect the open space of the housing 2 from contamination. The fourth sterile barrier membrane 45 is connected to a fourth membrane 46, which is inserted through the third passage of the housing and the third orifice 44 of the release liner 20, the third orifice 44 being arranged in the third passage of the housing 2. A third region 47 of the reinforcing sheet is arranged to cover the third orifice 44. The fourth membrane 46 is at least connected to the release liner 20 such that the fourth sterile barrier membrane 45 can be removed along with the removal of the release liner 20 to open the interface opening 48.

[0091] Preferably, the reinforcing sheet is applied to the release liner by means of an applicator (preferably an applicator that maintains the reinforcing sheet under vacuum). The applicator is preferably configured to make the reinforcing sheet contact the release liner at an acute angle (preferably between 5° and 45°), whereby the applicator subsequently slides on the release liner at said angle. This can be achieved by providing suitable equipment that allows the applicator to slide across or along the release liner at the correct angle. Preferably, the reinforcing sheet includes an adhesive applied to the inner side of the reinforcing sheet, which is intended to contact a second side of the release liner. This allows for a reduction in the formation of air bubbles between the reinforcing sheet and the release liner, which could degrade the visual appearance of the injection device.

[0092] Therefore, a method for adhesively applying a reinforcing sheet (40) to a release liner (20) covering an adhesive surface (21) of a drug delivery device (1) may include the following steps: The reinforcing sheet is non-adhesively attached to the surface of the applicator using negative pressure, wherein the surface of the applicator has the same shape as the reinforcing sheet, and the adhesive surface of the reinforcing sheet faces away from the applicator; The surface with the reinforcing sheet is moved above the second surface of the release liner at an angle between 0° and 90°, preferably between 5° and 45°; The applicator is moved toward the release liner, wherein the first edge of the applicator contacts the side region of the release liner, such that the edge of the reinforcing sheet is attached to the release liner; The applicator is moved toward the opposite side of the release liner, wherein the reinforcing sheet is pressed against the liner by the edge of the applicator and attached to the release liner in a bubble-free manner.

Claims

1. A pharmaceutical delivery device (1) for injecting or infusing a substance, comprising a housing (2) having an adhesive layer (21) on a surface of the housing and a release liner (20) at least partially covering the adhesive layer, the release liner comprising a sheet of material having a first surface in contact with the adhesive layer and orifices (28, 32) defining a passage through the sheet of material, wherein, The release liner is covered by a reinforcing sheet (40) attached to a second surface of the material sheet, characterized in that the reinforcing sheet includes a region forming a recess (43) oriented toward or at least partially disposed above the orifice of the release liner.

2. The drug delivery device according to claim 1, characterized in that, The recess has an elongated shape that tapers toward the orifice.

3. The drug delivery device according to claim 1, characterized in that, The recess has at least a partial trapezoidal shape with rounded corners, and the shorter part of its bottom is positioned toward or above the opening.

4. The pharmaceutical delivery device according to any one of claims 1 to 3, characterized in that, The drug delivery device includes a membrane connected to a sterile barrier foil located within the housing, the membrane passing through the orifice and being attached to the inside of the reinforcing sheet by means of an adhesive.

5. The drug delivery device according to claim 4, characterized in that, The membrane is connected to the second surface of the material sheet of the release liner via a first membrane surface, and to the inner side of the reinforcing sheet via a second membrane surface.

6. The pharmaceutical delivery device according to any one of claims 4 or 5, characterized in that, The at least one orifice is configured as a notch on the side edge of the release liner.

7. The pharmaceutical delivery device according to any one of claims 4 to 6, characterized in that, A first membrane connected to a first sterile barrier foil is inserted through a passage through the orifice and through the housing, wherein the first sterile barrier foil closes at least one opening in a fluid path located within the housing.

8. The pharmaceutical delivery device according to any one of claims 4 to 7, characterized in that, The injection device includes a container held within the housing, the container containing a drug and including at least one opening, the at least one opening being closed by a diaphragm, a second sterile barrier foil disposed on the diaphragm, and the injection device further includes a second membrane connected to the second sterile barrier foil, the second membrane being inserted into a passage through the at least one opening and through the housing.

9. The injection device according to any one of claims 1 to 8, characterized in that, The injection device includes a passage for a hollow needle configured to move from a first position to a second position, in the first position the tip of the hollow needle is located inside the housing, and in the second position the tip of the hollow needle is located outside the housing, the passage being covered by a third sterile barrier foil, wherein the orifice of the release liner is located on the passage.

10. The pharmaceutical delivery device according to any one of claims 1 to 9, characterized in that, The injection device includes a reusable drive module that is releasably connected to the housing at a connection interface of the housing. The connection interface includes at least one first mechanical connection device that is releasably connected to at least one second mechanical connection device of the reusable drive module.

11. The pharmaceutical delivery device according to claim 10, characterized in that, The connection interface includes at least one interface opening, which is closed by a fourth sterile barrier foil connected to a fourth membrane, which is inserted through a third orifice of the release liner.

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