Method for manufacturing a drug delivery device

Abstract

1. A method for manufacturing a drug delivery device, the drug delivery device comprising: a prefilled drug container (6); a fluid pack comprising a liquid flow system (7) providing a fluid connection from the drug container to a patient during a drug delivery action of the drug delivery device; a control unit comprising electronic components; and a housing (2), the method comprising the following steps: a) assembling components of the fluid pack to form said fluid pack; b) sterilizing the fluid pack; c) providing a prefilled drug container; d) assembling the fluid pack to the prefilled drug container to form a reservoir pack system; and e) assembling the reservoir pack system to the control unit and the housing (2) to form the drug delivery device, wherein steps c) and d) are performed under sterile conditions.

Description

[Technical field]

[0001] The present invention relates to a method for manufacturing a drug delivery device for the subcutaneous administration of a liquid drug, and in particular to a method for manufacturing a drug delivery device in the form of a patch device. [Background technology]

[0002] Drug delivery devices in the form of patch devices worn on the skin of a patient for subcutaneous delivery of liquid drugs are known. Some devices typically have an internal reservoir that receives a cartridge or is filled by the patient / medical professional. In this case, the drug is taken from a vial and transferred into the internal reservoir using a syringe. Cartridges are widespread and their handling is very simple, so it is advantageous to provide a device that can be used with standard cartridges. The liquid drug can be, for example, a biological pharmaceutical product or other drug that is simply administered for one-shot administration within a rather short time depending on the intended use. It is known to provide drug delivery devices in the form of patch devices with a single-use disposable component assembled to a reusable component that houses the drive and control electronics, or as a single disposable component.

[0003] Reliability, safety, compactness and ease of use of a patient-worn drug delivery device are important. For disposable components, the quantity of parts and, therefore, the cost of the disposable device are also important considerations.

[0004] To meet the requirements of safety and reliability, many conventional patch pump drug delivery devices have complex pump mechanisms and are rather bulky, and long shelf life and proper sterilization are often difficult to achieve, which increases the manufacturing cost.

[0005] Various methods of manufacturing a drug delivery device are conceivable. A first method comprises the following steps: a) Manufacturing of fluid packs, housings and control units b) Sterilization of the fluid pack, housing and control unit c) Supply to the sterile area for assembly with prefilled containers Includes.

[0006] However, an important issue to consider is that the sterilization process can destroy electronic components, batteries, and medications in prefilled containers.

[0007] Drug delivery devices are typically manufactured by manufacturing their single components in a first step. After manufacturing the single components, they are sterilized in a known type of sterilization process. After sterilization, the components are transferred to an area having aseptic conditions. In this area the components are usually assembled. The problem with using traditional assembly processes is that these processes are not suitable for components, including electronic components, batteries, or sensitive drugs in prefilled containers. The risk of destroying electronic components, batteries, or sensitive drugs in prefilled containers by sterilizing them is not acceptable. Therefore, traditional manufacturing processes cannot provide a functional assembly and ultimately cannot guarantee the safety of the patient.

[0008] The second method involves the following steps: a) Manufacturing / fitting of fluid packs, housings and control units under sterile conditions b) Assembly with prefilled containers may include. An important issue to consider is that this process limits the manufacturing methods that can be used, as processes such as welding, gluing, subtractive processes, and other processes that generate particles are not suitable under sterile conditions. It also means introducing many parts into the clean room, which increases the risk of contaminating the clean room conditions.

[0009] Such methods are not suitable, so current methods typically employ: - the medication delivery device is not delivered with an integrated prefilled medication container and the patient must install the prefilled medication container themselves. The disadvantages are that this requires more user steps and there is a risk that the medication container will not be inserted properly or the lid will not be closed properly; or, -The drug container is assembled under normal cleanroom conditions and a UV light source is added to the area requiring sterilization. Before the cartridge needle is inserted, the UV light source sterilizes the critical areas of the container needle and its bulkhead. The drawback of this method is that it may be difficult to show evidence of UV sterilization, since normal cleanroom conditions may tolerate many types of bacteria that have not yet been demonstrated to react to UV light. Summary of the Invention [Problem to be solved by the invention]

[0010] In view of the above, it is an object of the present invention to provide a method for manufacturing a drug delivery device, in particular in the form of a patch device, with a disposable unit or as a completely disposable device, for administration of liquid drugs, which is safe, reliable and compact.

[0011] It would be advantageous to provide a method of manufacturing a medication delivery device that can be used to administer a liquid medication provided in a medication container with a plunger.

[0012] It would be advantageous to provide a method for manufacturing a drug delivery device that is easy to use, particularly where some steps are performed by the patient.

[0013] It would be advantageous to provide a method of manufacturing a drug delivery device that is economical to manufacture.

[0014] It is therefore important to avoid the need to build expensive manufacturing lines in a sterile environment (according to class 5 or below of ISO standard 14644-1).

[0015] It would be advantageous to provide a method for producing a drug delivery device that has an extended shelf life. [Means for solving the problem]

[0016] The object of the present invention has been achieved by providing a method for manufacturing a drug delivery device according to claim 1. Various advantageous embodiments are set out in the dependent claims.

[0017] Disclosed herein, according to a first aspect of the present invention, is a method of manufacturing a drug delivery device, the drug delivery device comprising: - a prefilled medication container, the medication container including a barrel portion and a plunger slidably mounted within the barrel portion to seal the medication within the container; a fluid pack including a fluid flow system providing a fluid connection from a medication container to a patient during a medication delivery action of the medication delivery device; a control or drive unit including electronic components; a housing; The method is as follows: a) assembling fluid pack components to form said fluid pack; b) sterilizing the fluid pack; c) providing said prefilled medication container; d) assembling the post-sterilization fluid pack to the prefilled medication container to form a container-pack system; e) assembling the container pack system to the control unit and the housing (2) to form a medication delivery device; Steps c) and d) are carried out under sterile conditions.

[0018] In an advantageous embodiment, the medicament container includes a barrel portion and a plunger slidably mounted within the barrel portion to seal the medicament within the container.

[0019] Step a) concerns the assembly of a fluid pack of the drug delivery device. The fluid pack includes at least a liquid flow system that can provide a fluid connection from the prefilled drug container to the patient's body during the drug delivery action of the drug delivery device. The liquid flow system usually includes different components of different materials. For example, the cannula on the patient side may include metal, while the fluid pathway is usually made of channels or flexible tubes made from or formed by plastic parts.

[0020] Step b) concerns sterilization of the fluid pack. Since the assembled fluid pack is not usually manufactured under sterile conditions, the fluid pack must be sterilized to ensure that the patient cannula, cartridge needle and the entire fluid pathway are not contaminated. The usual sterilization method to achieve sterility of the assembly depends on the combination of various materials as well as the design of the product (e.g. recesses). Common sterilization methods for fluid packs are gamma irradiation, ethylene oxide (ETO) sterilization, nitrogen dioxide (NO2) sterilization, steam sterilization, vaporized hydrogen peroxide (VHP) sterilization, X-ray sterilization or electron beam sterilization.

[0021] Step c) concerns the provision of a prefilled drug container. The container may be made of glass, polymer, or other materials that are inert with respect to the stability of the drug and preferably biocompatible. Glass is commonly used in commercially available and FDA approved drug containers from many different manufacturers. As a result, there are established and approved procedures for filling and storing drugs aseptically in glass containers, which can accelerate the approval process of drug pump devices that protect the drug in the glass container. Polymer containers, for example made of COP (cycloolefin polymer) or COC (cycloolefin copolymer), may be suitable for certain drugs that degrade more quickly when in contact with glass, such as protein drugs. After filling, the container is closed with a plunger, usually made of a rubber material. The container is filled and closed under aseptic conditions (Class 5 or less of ISO 14644-1).

[0022] Step d) involves assembling the fluid pack with the prefilled medication container to form a reservoir pack system, which may have a fluid connection between the fluid pack and the prefilled medication container, or the connection may be established separately, for example after manufacture or immediately prior to medication delivery to a patient.

[0023] Step e) involves assembling the reservoir pack system to a control or drive unit and a housing to form a drug delivery device. The assembly of the control or drive unit to the user interface of the reservoir pack system and the attachment of the housing can be achieved by standard form-fit connections or any other conventional manufacturing method. To achieve a water-tight or even gas-tight housing, this can also include welding or gluing processes.

[0024] Definition of aseptic conditions: Aseptic conditions ensure that the filling and assembly environment is free of pathogens such as bacteria, viruses, and other microorganisms that can cause disease, in addition to having a low particle count. Aseptic conditions can be achieved, for example, in a Class 5 cleanroom according to ISO 14644-1, or in a lower class number cleanroom (i.e., with higher standards).

[0025] In an advantageous embodiment of the method, step e) is not performed under sterile conditions. Electronic components are very sensitive to common sterilization methods such as gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization or electron beam sterilization. By performing step e) under non-sterile conditions, destruction of the electronic components is avoided. Thus, the assembly of the drug delivery device is performed without risk of destruction of the components, ensuring safety for the patient. Therefore, further, the manufacturing method of step e) is not limited to particle free or low particle emission joining technologies.

[0026] The container pack system includes a container casing that encloses the prefilled drug container. The container casing can be connected to a fluid pack so that the prefilled drug container can be kept sterile in a simple manner. The container can be in direct fluid communication with the liquid flow system, or the fluid pack includes a means for separately connecting the prefilled drug container to the liquid flow system, for example after manufacture or immediately prior to drug delivery to the patient.

[0027] The container pack system includes a pump system configured to cause the plunger to be further depressed within the prefilled container to administer the medication, and in an advantageous embodiment, the pump system effects medication delivery by drawing in ambient air and injecting it into the container casing.

[0028] The pump system includes a coupling interface of the pump system of the delivery unit, where the pump drive provides torque to the rotor of the pump system, and the coupling interface is sealed by a sealing membrane to maintain sterility after step b). The seal can be made of a thermoplastic elastomer (TPE) in a two component molding, or a separate TPE or elastomer that seals against the moving coupling interface. The seal can also be made to completely cover the coupling interface and break within the first rotation of the coupler. In this case, the seal can be made of polyethylene foil (e.g., Tyvek™ foil) rather than an elastomeric material.

[0029] In an advantageous embodiment of the method, the housing includes a user interface, which may include electronic components that are highly sensitive to common sterilization procedures.

[0030] In an advantageous embodiment of this method, the sterilization method in b) is either gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization or electron beam sterilization.

[0031] In an advantageous embodiment of the method, the assembly step of step e) comprises a form-fit connection. By carrying out step e) with a form-fit connection, this operation is simplified and may be possible to carry out in the same room (production line) as the filling and closing of the drug containers. The particle generation and the size of the equipment for carrying out and checking this step are small and therefore suitable for sterile conditions.

[0032] In an advantageous embodiment of this method, the form-fit connection provides a hermetic closure of the pre-filled medication container within the container pack system, such that the pre-filled medication container is not only gas- or liquid-tight, but is constructed to easily maintain sterility over the shelf life of the device.

[0033] In an embodiment of this method, a delivery unit as described below without a drug container assembled therein forms the fluid pack, a delivery unit with a drug container assembled therein forms the container pack, and a drive unit as described herein forms the control or drive unit including electronic components.

[0034] In embodiments of this method, the drug delivery device may have any one or more additional features of any of the device embodiments described below.

[0035] Also disclosed herein is a drug delivery device including a delivery unit including a drug container, a liquid flow system, a pump system, and a casing enclosing at least a portion of the drug container, the pump system, and the liquid flow system. The drug container includes a barrel portion and a plunger slidably mounted within the barrel portion and sealing the drug within the container at one end of the barrel portion, and the liquid flow system is fluidly connected to the drug container during delivery of the liquid drug. The drug container is contained within a container receiving cavity of a container casing portion of the casing, and the container receiving cavity is fluidly interconnected to a fluid outlet of the pump system in a gas-tight manner. The pump system includes a fluid inlet connected to ambient air, and the pump system is configured to pump ambient air drawn through the fluid inlet into the container receiving cavity, thereby applying pressure to a rear end of the plunger for delivery of the liquid drug.

[0036] In an advantageous embodiment, the pump system includes a pump engine, the pump engine comprising: a stator; - a rotor rotatably and axially slidably mounted at least partially within the stator, the rotor including a first axially extending portion having a first diameter and a second axially extending portion having a second diameter larger than the first diameter; and a first valve formed by a first valve seal mounted on the stator about the first axial extension and cooperating with a first channel in the rotor configured to allow fluid communication across the first valve seal when the first valve is in an open position; a second valve formed by a second valve seal mounted on the stator around the second axial extension and cooperating with a second channel in the rotor configured to allow fluid communication across the second valve seal when the second valve is in an open position; Includes.

[0037] In an advantageous embodiment, the drug container is a drug cartridge.

[0038] Also disclosed herein is a method for producing a medicament for use in a method for treating a vascular endothelial disorder comprising: - a delivery unit including a medicament container, the medicament container including a barrel portion and a plunger slidably mounted within the barrel portion and hermetically sealing against an inner surface of the barrel portion to contain a liquid medicament within the medicament container; an electronic control system and a plunger sensing system including an optical sensor including a transmitter and a receiver, the transmitter configured to transmit an optical signal to a rear end of the plunger, the receiver configured to receive an optical signal reflected from the rear end of the plunger, and the plunger sensing system connected to the electronic control system configured to measure a time of flight of the optical signal from the transmitter to the receiver and determine therefrom a position of the plunger within a cylindrical portion of the medicament container; A drug delivery device comprising:

[0039] In one embodiment, the delivery unit includes a casing including a container casing portion including a plunger end portion covering the end of the drug container facing the plunger, the plunger end portion including a transparent sensor window that allows an optical signal to pass through the plunger end portion of the container casing, the optical sensor is positioned on or adjacent to the sensor window, the transmitter is configured to transmit an optical signal through the sensor window to the rear end of the plunger, and the receiver is configured to receive the optical signal reflected from the rear end of the plunger and back through the sensor window.

[0040] In one embodiment, the plunger end portion of the container casing portion includes a raised portion that positions the sensor window a distance away from the rear end of the plunger end to enable optical time-of-flight measurement of the plunger in an initial position.

[0041] In one embodiment, the distance away from the rear end of the plunger is in the range of 5mm to 20mm.

[0042] In one embodiment, the delivery unit includes a casing including a container casing portion including a plunger end portion covering the end of the drug container facing the plunger, the plunger end portion including a transparent sensor prism that allows an optical signal to pass through the plunger end portion of the container casing, the optical sensor is positioned on or adjacent to a face of the sensor prism, the transmitter is configured to transmit an optical signal through the sensor prism to the rear end of the plunger, and the receiver is configured to receive the optical signal reflected from the rear end of the plunger and back through the sensor prism.

[0043] In one embodiment, the face of the sensor prism on which the optical sensor is mounted is substantially perpendicular to the direction of movement of the plunger.

[0044] Also disclosed herein is a drug delivery device including a delivery unit including a drug container, a liquid flow system, a pressurized gas source, and a casing enclosing at least a portion of the drug container, the pressurized gas source, and the liquid flow system therein. The drug container includes a barrel portion and a plunger slidably mounted within the barrel portion and sealing the drug within the container at one end of the barrel portion. The drug container is contained within a container receiving cavity of a container casing portion of the casing, the container receiving cavity being fluidly interconnected in a gas-tight manner to a fluid outlet of the pressurized gas source. The pressurized gas source is configured to provide pressurized gas within the container receiving cavity, thereby exerting pressure on a rear end of the plunger for delivery of the liquid drug. The drug delivery device further includes a pressure sensor fluidly connected to the container casing for measuring the pressure inside the container casing, the pressure sensor being connected to an electronic control system configured to measure the pressure detected by the pressure sensor over time and to determine from the pressure measurements over time the position of the plunger over time, including cessation of plunger movement due to either a blockage in the drug delivery flow system or an end of plunger movement within the container corresponding to an empty position of the container.

[0045] In an advantageous embodiment, the pressurized gas source includes a pump system configured to pump gas into the container receiving cavity, thereby exerting pressure on the rear end of the plunger.

[0046] In an advantageous embodiment, the pump system is configured to pump ambient air into the container receiving cavity, thus exerting pressure on the rear end of the plunger.

[0047] Also disclosed herein is a medication delivery device including a delivery unit including a medication container in the form of a medication cartridge containing a liquid medication therein, a liquid flow system, a pump system, and a casing in which at least a portion of the medication container, pump system, and liquid flow system are mounted. The medication container includes a septum sealing an end of the medication container. The liquid flow system includes an injection delivery system including an injection needle configured to inject a medication in an activated state of the medication delivery device, the liquid flow system further including a container fluid connection system including a septum needle mounted on a movable septum needle support, a spring urging the septum needle support towards the septum of the medication container, and a blocking organ movable from a blocking position in which the septum needle support is held in a retracted position in which the septum needle is not in contact with the septum to an activated position in which the septum needle support is released and allowed to move towards the septum of the medication container such that the septum needle penetrates the septum under the force of the spring.

[0048] In an advantageous embodiment, the blocking device includes a rotatable support ring and blocking fingers extending from the support ring, the blocking fingers being rotatably movable with the support ring from a position in which the blocking fingers engage the septum needle support to maintain it in a retracted position to an actuated position in which the blocking fingers disengage the septum needle support and move it to an actuator position in which the septum needle passes through the septum.

[0049] In an advantageous embodiment, the septum needle support includes a flange section and a gap between the flange sections, and the blocking finger engages the flange section during a blocking position in which the septum needle support is retracted.

[0050] In an advantageous embodiment, the septum needle support includes guides on opposing portions which engage complementary guide portions in the casing to slidably guide the septum needle support from a retracted position to a septum-piercing position.

[0051] In an advantageous embodiment, the injection delivery system includes a needle actuation mechanism configured to move the injection needle from a retracted position within a housing of the medication delivery device to an extended delivery position in which the injection needle protrudes through a base wall of the housing, the needle actuation mechanism including a rotating actuation disk configured to engage an actuation lever coupled to a slidable septum needle support for movement between the retracted position and the extended delivery position.

[0052] In an advantageous embodiment, the actuation disk is directly connected to or formed integrally with the rotor of a pump engine of the pump system.

[0053] In an advantageous embodiment, an actuation lever is connected to the blocking device for moving the blocking device from the locked position to the unlocked position.

[0054] In an advantageous embodiment, the actuation lever includes a support ring mounted about a shroud portion of the casing which surrounds a cavity for receiving the septum end of the medicament container therein.

[0055] In an advantageous embodiment, the actuation lever comprises a lever arm extending from a rotatable support ring configured to engage a recess in the actuation disc upon initial actuation of the medication delivery device.

[0056] Also disclosed herein is a drug delivery device including a housing, a delivery unit including a drug container, and a control unit mounted inside the housing, the control unit including an on-body sensing system including an electrode connected to the electronic control system of the control unit for measuring capacitance values ​​configured to detect whether the drug delivery device is positioned against the skin of a patient. The skin-contacting wall of the housing has an inner side facing the inside of the housing on which the delivery unit and the control unit are mounted, and an outer mounting side facing the outside of the housing and intended to be applied to the skin of a patient. The electrode includes a layer of metal mounted directly against the inner side of the skin-contacting wall.

[0057] In an advantageous embodiment, the metal layer of the electrode consists of a metal layer deposited directly on said inner surface of the skin-contacting wall.

[0058] In an advantageous embodiment, the directly deposited metal layer is a galvanic plated layer.

[0059] In an advantageous embodiment, the on-body sensing system further includes a shield in the form of a conductor surrounding the electrode.

[0060] In an advantageous embodiment, the on-body sensing system is configured to measure a capacitance value between said electrode and a ground value.

[0061] In an advantageous embodiment, the on-body sensing system includes a second electrode insulatingally separated from said electrode constituting the first electrode, and the potential between the first electrode and the second electrode is measured to determine the capacitance value.

[0062] In an advantageous embodiment, the second electrode is formed as a metal layer directly on the inner side of the mounting wall.

[0063] In an advantageous embodiment, the second electrode is formed as a metal layer, just like the first electrode.

[0064] In an advantageous embodiment, the second electrode and the first electrode have interleaved portions.

[0065] In various embodiments, the drug container can include a septum at one end of the drug container, which is pierced by a septum needle fluidly connected to the injection needle during actuation of the drug delivery device.

[0066] In various embodiments, the drug delivery device may include an injection needle mounted on a movable needle support configured to move the needle from a retracted position in which the needle is completely inside the housing, to an actuated position in which the needle tip protrudes from the skin-contacting wall of the housing for injection delivery of a liquid drug.

[0067] In various embodiments, the liquid flow system may include an injection delivery system including an injection needle mounted on a moveable needle support connected via a conduit to a container fluid connection system including a septum needle.

[0068] In various embodiments, the drug delivery device may further include a drive unit including a pump drive having a connection interface that connects to a drive connection interface of a pump system of the delivery unit, the pump drive providing torque to a rotor of the pump system.

[0069] In various embodiments, the drug delivery device may include a housing in which the delivery unit and the drive unit are assembled, the housing including a skin-contacting wall that is placed against the patient's skin, the skin-contacting wall including an adhesive patch having a protective film.

[0070] In various embodiments, for certain medical applications, the medication delivery device may be configured as a single-use, disposable device, and in particular may be configured for a single administration of a liquid medication contained within the container.

[0071] Further objects and advantageous features of the present invention will become apparent from the appended claims, detailed description and accompanying drawings. [Brief description of the drawings]

[0072] [Figure 1a] 1 is a perspective view of a medication delivery device according to an embodiment of the present invention; [Figure 1b] FIG. 1b is a perspective view of the device of FIG. 1a with the cover and adhesive with protective film disassembled. [Diagram 2] FIG. 1c is an exploded view of the embodiment of FIG. 1b with the cover and adhesive with protective film removed to show the housing base, delivery unit and drive unit. [Figure 3a]3 is an exploded view of the drive unit of FIG. 2 showing a drug container inside the drive delivery unit according to an embodiment of the present invention. [Figure 3b] FIG. 2 is a perspective cross-sectional view of a dispensing unit according to an embodiment of the present invention. [Figure 3c] FIG. 2 is a perspective cross-sectional view of a dispensing unit according to an embodiment of the present invention. [Figure 4a] FIG. 2 is a perspective view of a pump and fluid flow system of a delivery unit of a medication delivery device according to an embodiment of the present invention. [Figure 4b] FIG. 4b is a perspective exploded view of the liquid flow pump system of FIG. 4a. [Figure 4c] FIG. 4b is a perspective exploded view of the liquid flow pump system of FIG. 4a. [Figure 5a] 1 is a cross-sectional view of a fluid flow and pump system of a drug delivery device according to an embodiment of the present invention, illustrating steps in the actuation of a needle of a transdermal delivery system and a needle of a reservoir fluid connection system when the drug delivery device is actuated. [Figure 5b] 1 is a cross-sectional view of a fluid flow and pump system of a drug delivery device according to an embodiment of the present invention, illustrating different steps in the actuation of a needle of a transdermal delivery system and a needle of a reservoir fluid connection system when the drug delivery device is actuated. [Figure 5c] 1 is a cross-sectional view of a fluid flow and pump system of a drug delivery device according to an embodiment of the present invention, illustrating different steps in the actuation of a needle of a transdermal delivery system and a needle of a reservoir fluid connection system when the drug delivery device is actuated. [Figure 5d] 1 is a cross-sectional view of a fluid flow and pump system of a drug delivery device according to an embodiment of the present invention, illustrating different steps in the actuation of a needle of a transdermal delivery system and a needle of a reservoir fluid connection system when the drug delivery device is actuated. [Figure 5e] 1 is a cross-sectional view of a fluid flow and pump system of a drug delivery device according to an embodiment of the present invention, illustrating different steps in the actuation of a needle of a transdermal delivery system and a needle of a reservoir fluid connection system when the drug delivery device is actuated. [Figure 6a]FIG. 5b is a perspective view of the device of FIG. 5a (with outer housing parts removed for better internal visibility) in an initial position corresponding to FIG. 5a. [Figure 6b] FIG. 6b is a view similar to FIG. 6a, showing an intermediate actuation position corresponding to FIG. 5c; [Figure 6c] FIG. 6b is a view similar to FIG. 6b with part of the housing added in cross section, showing a position corresponding to FIG. 5e, which is the end position with both needles fully inserted. [Figure 6d] FIG. 6b is a perspective view of the device of FIG. 6a from the opposite side. [Figure 6e] FIG. 6c is a view similar to FIG. 6d, showing an intermediate actuation position just as the septum needle is about to be released. [Figure 6f] FIG. 6f is a view similar to FIGS. 6d and 6e, but showing the end position with both needles fully inserted. [Figure 7a] FIG. 7a is a perspective cross-sectional view taken along line 7a-7a in FIG. 5a. [Figure 7b] FIG. 7B is a cross-sectional view taken along line 7b-7b of FIG. 5e. [Figure 8a] FIG. 8a is a cross-sectional view taken along line 8a-8a of FIG. 7a. [Figure 8b] FIG. 8b is a cross-sectional view taken along line 8b-8b of FIG. 7a. [Figure 9a] FIG. 5b is a cross-sectional view taken along line 9a-9a of FIG. 5a. [Figure 9b] FIG. 5b is a cross-sectional view taken along line 9b-9b of FIG. 5e. [Figure 10a] FIG. 2 is a perspective exploded view of a drive unit of a medication delivery device according to an embodiment of the present invention. [Figure 10b] FIG. 2 is a cross-sectional view of a portion of a medication delivery device according to an embodiment of the present invention, showing a drive unit in a disconnected state from a delivery unit of the medication delivery device according to an embodiment of the present invention; [Figure 10c] FIG. 10b is a view similar to FIG. 10b, showing the connected state. [Figure 11a]FIG. 2 is a perspective view of a drug delivery device according to an embodiment of the present invention with the housing removed, showing the delivery unit and drive unit assembled, together with a schematic diagram of a plunger sensing system according to a first variant; [Figure 11b] 11b is a cross-sectional view taken along line 11b-11b in FIG. 11a. [Figure 12a] FIG. 11b is a perspective view of a variation of the device of FIG. [Figure 12b] 12b is a cross-sectional view taken along line 12b-12b in FIG. 12a. [Figure 13] FIG. 2 is a cross-sectional view of a liquid flow and pump system of a medication delivery device according to an embodiment of the present invention, showing the air flow system of the pneumatic drive. [Figure 14a] FIG. 14 is a partial cross-sectional view showing a sealing membrane covering the pump-engine connection interface of the device of FIG. 13. [Figure 14b] FIG. 1 is a perspective view of a first embodiment of a sealing interface. [Figure 14c] FIG. 13 is a perspective view of a second embodiment of a sealing interface. [Figure 15a] FIG. 2 is a schematic diagram of a drug container in a liquid flow pump system of a drug delivery device according to an embodiment of the present invention, showing a pneumatic drive and pneumatic plunger sensing system. [Figure 15b] FIG. 2 is a schematic diagram of a plot of pressure as a function of time for a pneumatic plunger system in accordance with an embodiment of the present invention. [Figure 15c] 1 is a schematic diagram of a plot of drug flow rate over time as measured by a pneumatic plunger sensing system in accordance with an embodiment of the present invention. [Figure 15d] 11 is a corresponding plot of air pressure over time within a reservoir holder of a medication delivery device. [Figure 16a] 1 is a perspective view of a medication delivery device according to an embodiment of the present invention; [Figure 16b] FIG. 16b is a perspective view of the drug delivery device of FIG. 16a before the drug container has been removed or inserted into the drug delivery device. [Figure 16c]FIG. 16c is a perspective view of a drug container and a closure cap fitted onto the plunger of the drug container, which are inserted into the drug delivery device of FIG. 16b. [Figure 16d] FIG. 16c is a cross-sectional view of the drug container cap of FIG. [Figure 16e] FIG. 16b is a cross-sectional view of the embodiment of FIG. 16a. [Figure 17a] 13 is a perspective, partially cross-sectional view of a medication delivery device according to yet another embodiment of the present invention, with certain components removed. FIG. [Figure 17b] FIG. 17b is a view similar to FIG. 17a, showing the components in cross-sectional plan view. [Figure 18a] 1 is a schematic diagram of an on-body sensing system of a medication delivery device according to an embodiment of the present invention. [Figure 18b] FIG. 2 is a perspective view of a delivery unit coupled to a drive unit of a medication delivery device according to an embodiment of the present invention, illustrating components of an on-body sensing system. [Figure 18c] 1 is a perspective view of a housing cover of a medication delivery device showing components of an on-body sensing system according to an embodiment of the present invention. [Figure 18d] 1 is a schematic diagram of an on-body sensing system of a medication delivery device according to an embodiment of the present invention, comprising two electrodes. [Figure 19a] 1 is a schematic diagram of an embodiment of the assembly and sterilization steps of a drug delivery device according to an embodiment of the present invention. [Figure 19b] 11 is a schematic diagram of another embodiment of the assembly and sterilization steps of a drug delivery device according to another embodiment of the present invention. [Figure 19c] 11 is a schematic diagram of another embodiment of the assembly and sterilization steps of a drug delivery device according to another embodiment of the present invention. [Figure 19d] 11 is a schematic diagram of another embodiment of the assembly and sterilization steps of a drug delivery device according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0073] Referring to the figure, a medication delivery device 1 according to an embodiment of the present invention includes a housing 2, a delivery unit 3, and a control or drive unit 4, where the delivery unit 3 and the control or drive unit 4 are assembled inside the housing 2. The housing 2 may be made of two or more parts, and the delivery unit, drive unit, and any other components may be assembled inside the housing.

[0074] In the illustrated embodiment, the drug delivery device 1 is a single-use disposable unit for subcutaneous administration of a liquid medicament (drug). Administration may be in a single dose over a short period of time, typically less than an hour, for example about 30 minutes or less. The single-use disposable drug delivery device may also be used for subcutaneous injection of liquid medicaments over extended periods of time, from a few hours to a few days, or even up to 1-3 weeks. Depending on the amount of drug to be injected, the drug delivery device may also be configured to inject the liquid drug within a few minutes.

[0075] There are various applications in which it is advantageous to provide a patient in need of a drug with a drug delivery device that the patient can wear on the patient's body or directly on the patient's skin before use to inject the drug outside of a hospital or medical institution, for example at home. In some medical applications, there may also be a need to deliver liquid drugs within a range of times, for example once the patient returns home after an event such as a surgical intervention or other form of treatment in a hospital or clinic. There are also applications in which it is advantageous to provide the patient with a drug delivery device for injecting a drug at a specific time, for example once a week or once a month, or at various other intervals depending on the drug and treatment, so that the patient does not need to have the drug administered by a medical professional in a clinical environment, for example so that the patient can perform the treatment at home.

[0076] Although the illustrated embodiment relates to a single-use disposable drug delivery device, within the scope of the invention with respect to the various aspects described herein, a drug delivery device having a disposable part that can be assembled to a reusable part including the drive unit, electronics and power source can also be used. The delivery unit 3 can be mounted in a housing of the drug delivery device, and the drive unit 4 can be mounted in a separable housing part, and the drive unit 4 can be reused in a subsequent delivery unit. Examples of drug delivery devices with single-use disposable and reusable parts are described, for example, in WO2020109409.

[0077] The medication delivery device includes a user interface 55 which may include one or more buttons for operating the medication delivery device, light and / or sound status indicators, and optionally a screen or other display for presenting information to an operator of the device.

[0078] The drug delivery device according to an embodiment of the present invention may advantageously be configured as a patch device for attachment to the skin of a patient. An adhesive layer (not shown) may be provided on the outer surface of the skin-contacting wall 81 of the housing 2, for example on the surface of the cover 2b, covered by a protective film which may be peeled off from the adhesive layer before applying it on the patient's skin at the injection site. The needle orifice 10 through the skin-contacting wall 81 is covered with a protective film 11 before use, allowing the transdermal injection needle 15 to extend through the needle orifice and pierce the patient's skin upon activation of the drug delivery device 1.

[0079] The delivery unit 3 includes a drug container 6, e.g. a drug cartridge, containing a liquid drug 78, a liquid flow system 7 for delivering the liquid drug subcutaneously to the patient, a pump system 8, and a casing 9 for housing the drug container, the liquid flow system 7 and the pump system 8.

[0080] In an embodiment, the casing 9 may be configured to sealingly surround the drug container, and gas pressure within the casing portion around the drug container may be generated to provide pumping action of the drug, as described in further detail herein.

[0081] The drug container 6 may be a conventional type drug cartridge including a container having a barrel portion 6a, a neck portion 6b having an open end closed by a septum 6c, and a plunger 12 closing the open end of the barrel portion 6a, with the liquid drug 78 to be administered to the patient being sealably contained within the barrel portion 6a between the plunger and the septum. Such drug containers 6 are well known in the pharmaceutical industry and may be used to sterilely contain many different types of liquid drugs. It will be appreciated that such drugs may also be provided in different sizes (volumes), and drug delivery devices according to embodiments of the present invention may be dimensioned to take into account different types of drug containers depending on the medical application. Embodiments of the present invention may also be used with non-standard drug containers.

[0082] It should be noted that, although certain aspects of the invention disclosed herein require a drug container that includes a sliding plunger, certain other aspects of the invention disclosed herein are not limited to use with drug containers having plungers, but may be used with other forms of drug containers that lack plungers. For example, the on-body sensing system is independent of the type of drug container used in the drug delivery device, as described below. Also, for example, the container fluid connection system 17 requires a drug container that has a pierceable sterility barrier, as described below, but does not necessarily require a drug container that has a plunger. Furthermore, the method of manufacturing the drug delivery device is independent of the type of drug container used in the drug delivery device, as described below.

[0083] The delivery unit 3 incorporates a pump system 8 which drives liquid from a container into the injection needle 15 when the drug delivery device is activated. The pump system includes a drive coupling interface 33 which couples to a coupling interface 54 of a pump drive 52 of the drive unit 4. The drive unit thus provides mechanical power via couplings 54, 33 to drive the pump system 8.

[0084] The pump engine 28 may advantageously comprise a similar design and configuration to the pump engines described in WO2007074363 or WO2015015379, in which a rotor 32 is mounted inside a stator 29 and is rotatably and axially removable therein to pump fluid from a fluid inlet 30 to a fluid outlet 31. As is known from the above publications, the rotor 32 has a pump shaft 36 having first and second diameters surrounded by seals that open and close a fluid channel between the inlet and the outlet as the rotor rotates and is displaced axially by a cam mechanism between the stator and the rotor, thereby providing a pumping action during opening and closing of valves between the fluid inlet and the pump chamber or between the pump chamber and the outlet.

[0085] In summary, the pump engine 28 according to the preferred embodiment: a stator 29; a rotor 32 slidably and rotatably mounted at least partially within the stator, the rotor 32 including a first axial extension having a first diameter and a second axial extension having a second diameter larger than the first diameter; a first valve formed by a first valve seal mounted on the stator about the first axial extension and cooperating with a first channel in the rotor configured to allow liquid communication across the first valve seal when the first valve is in an open position; a second valve formed by a second valve seal mounted on the stator about the second axial extension and cooperating with a second channel in the rotor configured to allow liquid communication across the second valve seal when the second valve is in an open position; Includes.

[0086] The general design of the pump engine and pumping principles can be understood by reference to the above-mentioned publications, however, in embodiments of the present invention, the pump system is not fluidly connected to the liquid to be dispensed. Rather, in embodiments of the present invention, the pump engine may be advantageously used to pump air, which creates pressure against the container plunger to displace it and force the liquid out of the container when the septum is pierced.

[0087] In advantageous embodiments of the invention, particularly for single use and single injections of the contents of the medication container over periods ranging from a few minutes to 60 minutes, for example, the pump engine may be used to pump air which creates pressure against the plunger 12 to advance the plunger against the septum and force liquid 78 inside the container through the injection needle 15 of the subcutaneous delivery system 13, via the liquid flow system 7. Thus, in these embodiments, the pump system 8 acts as a pneumatic drive which generates air pressure in at least a portion of the casing 9 behind the plunger 12, as best shown in FIG.

[0088] An important advantage of using such a pump engine in an embodiment of the drug delivery device of the present invention is that there is no direct fluid connection between the inlet and the outlet at any position of the rotor and no actuation of any valves is required, so that a particularly reliable pumping of gas is guaranteed without leakage and in an easy to operate arrangement. The pump engine 28 is very compact and can be driven directly, without gearing, by the rotary electric motor 53 of the pump drive 52 of the drive unit 4. Indeed, due to the differential pumping volume displacement defined by the axial displacement of the rotor and the difference between the first and second diameters of the pump shaft, the pumping volume displacement rotation can be easily configured to work optimally with a given type of electric motor rotating at a constant speed. Furthermore, the parts of the pump engine can be made entirely of polymeric materials and the rotor can be easily connected to the pump drive, ensuring a sterile barrier between the fluid parts of the pump engine and the connection interface.

[0089] It should be noted that certain aspects of the embodiments of the invention described herein do not necessarily depend on a pneumatic drive to function. For example, the on-body sensing system 5 and the plunger sensing system 70 using the optical sensor 71 do not necessarily require a pneumatic drive and can also be implemented in a drug delivery device in which the pump engine acts directly on the liquid drug in a conventional manner, for example as described in WO2015015379, or using other pump systems known per se in the art that act directly to draw liquid from the container. Also, the container fluid connection system 17 described in more detail below can be implemented with a different pump system, for example with a pneumatic drive, or with a drive that mechanically pushes the plunger as known per se, or by aspirating liquid using the engine described in WO2015015379.

[0090] The drive unit 4 is primarily configured to drive the pump system 8 of the delivery unit 3, but may also have additional functions such as processing sensed signals and transmitting data to and from external devices via a wireless communication link, e.g. using Bluetooth.

[0091] The drive unit 4 includes an electronic control system 47, which may include a circuit board 48 on which electronic components are mounted, including at least one microprocessor 49 and optionally a wireless connectivity module. The electronic control system further includes a power source 50, for example in the form of a battery, and a pump drive 52 including an electric motor 53.

[0092] The shaft of the motor 53 may be coupled to a coupling interface 54 configured to engage a complementary coupling interface 33 of the pump engine rotor 32 on the delivery unit 3. Where the pump engine 28 is configured with a rotatable and axially movable rotor as described above, in a preferred embodiment the drive coupling interface 54 may be axially slidable relative to the motor output shaft and biased by a spring 69 which urges the motor drive coupling interface 54 against the coupling interface 33 of the pump engine rotor 32, as best shown in Figures 10a-c.

[0093] The drive unit may further include a plunger sensing system 70 for sensing the position of the reservoir plunger to determine correct operation of the drug delivery device and to identify, for example, a blockage in the liquid flow system or the end of plunger movement when the drug reservoir is emptied at the end of the drug administration process. An embodiment of the plunger sensing system 70 is described in more detail below.

[0094] It should be noted that the plunger sensing system 70 for sensing the position of a plunger according to an embodiment of the present invention may be implemented in a variety of drug delivery systems having a drug container including a plunger, such as a syringe device, an autoinjector, a pen injection system (such as an insulin pen), or any other plunger movement in the primary packaging of a fluid drug.

[0095] The drive unit may further include an on-body sensing system 5 for detecting whether the drug delivery device is positioned against the patient's skin. The on-body sensing system prevents operation of the drug delivery device if it is not positioned against the patient's skin and can also detect if the drug delivery device is removed prior to complete delivery of the drug. An embodiment of the on-body sensing system 5 is described in more detail below.

[0096] The fluid flow system 7 includes a subcutaneous delivery system 13 including an injection needle 15 for penetrating the skin of a patient, and a reservoir fluid connection system 17 including a septum needle 18 for penetrating a septum 6c of the reservoir 6 upon actuation of the drug delivery device. The subcutaneous delivery system includes a needle support 16 slidably mounted within the housing 2 along a housing slide 67, the needle being mounted on the needle support and movable with the needle support 16 from a fully retracted position within the casing 9 of the delivery unit 3 as shown in Figures 6a, 6d and 9a, to a fully extended position during drug administration as shown in Figures 6c, 6f and 9b.

[0097] The needle and the fluid channel within the needle support are connected to a conduit 14 which may advantageously be in the form of a flexible tube allowing sliding movement of the needle support from a retracted position to an extended position, the tube having its other end connected to a container fluid connection system 17.

[0098] The container fluid connection system 17 includes a septum needle support 19 on which a septum needle 18 is mounted, the septum needle support 19 being slidably mounted within the housing and configured to move from a retracted position as shown in Figures 6a, 6d, 7a, and 8a to an extended position as shown in Figures 6c, 6f, 7b, and 8b. In the retracted position, the septum needle 18 is not in contact with the medicament 78 in the medicament container, and in the extended position, the septum needle 18 penetrates the seal member 27 (sterility barrier) and the septum 6c of the medicament container and is in contact with the liquid 78 in the container.

[0099] In an advantageous embodiment, the reservoir fluid connection system 17 may be actuated simultaneously with the subcutaneous delivery system 13. However, it should be noted that within the scope of the present invention, it is possible for the reservoir fluid connection system 17 to be actuated prior to, e.g., sequentially, actuating the subcutaneous delivery system 13. The step of first connecting the septum needle 18 with the drug liquid prior to penetrating the patient's skin with the injection needle 15 may allow the fluid connection, including the conduit 14, to be filled with drug prior to injection in order to remove air from the fluid channel prior to injection.

[0100] The container fluid system 17 in the preferred embodiment includes a slidable needle support 19 having a flange section 20 with a guide 22 at an outer end that slidably engages a complementary guide in the housing portion of the casing 9. The container fluid connection system 17 further includes a blocking device 24 having a blocking finger 26. In a locked position where the septum needle support 19 is in a retracted position as shown in Figures 6a, 6d, 7a, and 8a, the blocking finger 26 blocks the septum needle support in the retracted position by compressing at least one of the flange sections 20. A spring 23, which may be in the form of a conical coil spring, for example, compresses the rear side of the septum needle support with a spring force configured to move the septum needle support towards the drug container and through the sealing member 27 (sterility barrier) and the septum 6c. Other forms of springs may be provided within the scope of the invention. The blocking finger 26 can be disengaged from engagement with the septum needle support, for example by being moved into the gap between the flange sections 20, causing the spring 23 to urge the septum needle support towards the sealing member 27 and the septum 6c, with the septum needle 18 penetrating the sealing member and the septum.

[0101] The blocking fixture 24 may, in an advantageous embodiment, include a rotatable support ring 25 from which projecting blocking fingers 26. The rotatable support ring 25 is mounted around a shroud that defines a cavity into which a container cap, for example with a septum 6c, is inserted.

[0102] The block can be actuated by rotation of block 24 to release the septum needle support and allow the septum needle support to move from the retracted position to the extended position.

[0103] In an advantageous embodiment, movement of blocking finger 26 and its release from septum needle support 19 can be effected by actuation of pump engine 28 of pump system 8. Subcutaneous delivery system 13 can also be simultaneously actuated by initial rotation of rotor 32 of pump engine 28.

[0104] In the present invention, the subcutaneous delivery system may include a configuration similar to the delivery system described in WO2015015379, which is incorporated herein by reference. In such a configuration, the rotor 32 of the pump engine 28 includes an actuation disk 34 coupled to a pump shaft 36, the actuation disk including a recess 35 that engages a tip of a lever arm 65 connected to a support ring 66 of an actuation lever 64. As best seen with reference to Figures 5a-6c, 4b and 4c, the support ring 66 of the actuation lever 64 is rotatably mounted around a shroud that forms a cavity for receiving a container cap, while the lever arm 65 extends to a tip configured to hook into the recess 35 of the actuation disk 34 when the rotor 32 is rotated by the pump drive 52 of the drive unit 4.

[0105] As can be seen in Figures 5a and 6a, the initial position of the drug delivery device before first use is shown, in which the tip of the lever arm 65 rests against the outer circumferential surface of the actuation disk 34. When pump action is initiated upon actuation of the drug delivery device, the actuation disk 34 rotates (in a counterclockwise direction as shown) so that the tip of the lever arm 65 engages within the recess 35, as best seen in Figure 5b. Continued rotation of the rotor then causes the actuation lever 64 to pivot (in a clockwise manner as shown in Figures 5c, 5d and 6b) to the fully actuated position shown in Figure 5e, with the injection needle 15 fully extended. The actuation lever 64 is also connected by a pin, protrusion or other device (not visible) to the support ring 25 of the block 24, causing it to rotate (in a clockwise manner as shown in Figures 5b-5d) so that its block finger 26 disengages the septum needle support 19.

[0106] Thus, in the advantageous embodiment described above, actuation of the pump drive automatically and simultaneously actuates both the subcutaneous delivery system 13 and the container integral connection system 17 for administration of the medication. This simultaneous actuation upon start-up of the pump system has the advantage that hermetic containment of the medication within the container is ensured until administration of the medication to the patient, resulting in improved sterility and shelf life.

[0107] As best seen in Figures 7a and 3c, a sealing member 27 may be provided to cover the central orifice in front of the retracted septum needle before the septum needle 18 penetrates the container septum.

[0108] An orifice 68 in the casing 9 (see Figures 9a, 9b) through which the needle 15 extends may also include a sealing member which is pierced during actuation of the needle.

[0109] At the end of the injection cycle, the rotor 32 of the pump engine 28 is reversed, causing the actuation lever 64 and lever arm 65 to pivot in the opposite direction, causing the needle support 16 to return upwards, thus retracting the injection needle 15 inside the casing 9. The patient can then safely remove the drug delivery device without risk of anyone being pricked by the injection needle 15.

[0110] In an alternative embodiment (not shown), actuation of the container fluid connection system may be performed by a different mechanism, such as a manually actuated button on the housing, which pushes the blocking finger 26 out of engagement with the septum needle support 19. In such an arrangement, a sensor may be provided to prevent actuation of the subcutaneous delivery system 13 and pump system 8 until the container fluid connection system 17 is actuated.

[0111] In an embodiment including a pneumatic drive, the casing 9 includes a container casing 38 having a container receiving cavity 75 therein that surrounds the drug container 6 and is sealingly connected to a portion of the pump and needle system casing 37 that surrounds the septum needle exit orifice. The interior of the container casing 38 is fluidly connected to the outlet 31 of the pump engine 28 via a fluid channel 74, as best shown in FIG. 13. The pneumatic flow system 74 is sealed off from the volume inside the pump and needle system casing 37 that is located around the pump engine 8, in which an inlet 30 on the stator 29 of the pump engine 28 is positioned to draw air into the pump engine. Thus, the casing 9 may include a valved or filtered inlet (not shown) for drawing air into the volume surrounding the pump engine.

[0112] Advantageously, in the pneumatic drive configuration of an embodiment of the present invention, the pump system 8 is operated to generate gas pressure inside the container casing 38, which in turn exerts pressure on the rear end 73 of the plunger 12. This configuration allows for a very compact delivery unit, and thus the drug delivery device 1, since very little space is required behind the plunger, as there is no mechanical drive directly pushing the plunger. Also, the use of the pump engine 28 as described above, although known per se for pumping liquids, is particularly advantageous in pneumatic drive applications in terms of its very compact size and its ability to pump gases without the need for additional valves. Furthermore, the pump can be driven by an electric motor without the need for gearing. Sterilization of the delivery unit 3 is also easy to carry out as a substantially closed unit by gamma irradiation before assembly with the drug container 6.

[0113] 15a-d, a drug delivery device with a pneumatic flow system and pneumatic drive may include a pressure sensor 80 to measure the pressure in the pneumatic flow system 71. As shown in FIG. 15b, the pressure in the pneumatic flow system measured over time indicates the displacement of the plunger 12. Blockage of the plunger due to a blockage in the liquid flow system may be detected by an increase in the rate of increase of the pressure over time. Also, the end of the plunger travel, in other words the emptying of the drug container, may be easily detected by an increase in the rate of increase of the pressure, for example as identified in section E of FIG. 15b.

[0114] As shown in Fig. 15b, when a pneumatic pump system as described above is used, the pneumatic pumping action is preferably delivered in a pulsed manner, whereby a pump phase is followed by an inactive phase where the pump is stopped, such that there is a fluctuation in air pressure giving a sawtooth characteristic as shown in Fig. 15b and Fig. 15d. Each active pump phase can be obtained by a single rotation cycle (360° rotation) of the pump engine rotor 32, or by a predefined number of rotation cycles. The inactive phase where the pump is stopped can be of predefined duration depending on the desired drug delivery rate.

[0115] Pressure sensors are very economical and easy to integrate. Thus, the advantage of this pneumatic plunger position sensing system is that it is very low cost and easy to integrate, and is particularly well suited for single injection cycles where control of the average flow rate is required and where the end position of the plunger within the container needs to be determined, for example as shown in FIG. 15c. In such situations, there is no need to ascertain the plunger position precisely.

[0116] The plunger position may be determined by other sensing means, and in another embodiment, the plunger sensing system 70 includes an optical sensor 71 mounted on the rear end of the container facing the end 73 of the plunger 12. The container casing portion 38 of the casing 9 includes a sensor window 43 or sensor prism 43' mounted in the end portion 42 of the container casing 38 facing the plunger 12.

[0117] The optical sensor 71 may be positioned on the outer surface of a sensor window 43 or a sensor prism 43' made of a transparent material for the optical signal of the optical sensor 71. The optical sensor system may advantageously include a transmitter 71a and a receiver 71b that measure the distance of the sensor window to the rear end 73 of the plunger via a time-of-flight (TOF) measurement. Advantageously, such a time-of-flight optical sensor is particularly economical and easy to implement. To obtain a practical measurement, the window 43 may be positioned on the raised plunger end portion 42 such that at the initial position of the plunger 12 when the container is filled, it has a certain minimum distance of 3 mm to 30 mm, for example 5 mm to 20 mm, and the plunger initial position can be more easily detected by the optical time-of-flight measurement.

[0118] The optical sensor 71 may be mounted on a circuit board 72 projecting laterally from the drive unit 4, as shown diagrammatically in Figures 11a, 11b and 12a, 12b. In the variant shown in Figures 12a, 12b, the optical sensor may be positioned such that light is directed orthogonally to the direction of movement of the plunger, the light being reflected via a prism 43' having an internal reflective surface for total internal reflection, as known per se in the optical field. The prism also has the effect of increasing the initial movement of the transmitted and reflected light so that a meaningful measurement can be made of the initial position of the plunger when the container is filled.

[0119] As the plunger moves towards the empty position of the container, the accuracy of the time-of-flight measurement increases, resulting in greater accuracy as the container reaches the empty position.

[0120] The optical sensor may be used with a pneumatic drive as described above, but may also be used in drug delivery systems using other pump technologies, for example using a pump engine that draws fluid directly from a drug container and causes displacement of the plunger 12 by suction (vacuum) inside the container.

[0121] Thus, the plunger sensing system 70 with an optical sensor 71 based on a transparent window at the rear end of the container casing 38 is particularly cost effective and easy to deploy in a very compact arrangement.

[0122] 16a-16e, another embodiment of the drug delivery device 1 is shown in which the housing 2 is arranged differently. In this embodiment, instead of providing a container casing 38 that extends the entire length of the container 6, a cap 44 is provided that forms a plunger end portion 42 of the container casing and is configured to close a container receiving cavity 75 inside the housing 2. A sealing ring 41 can be provided between the cap end cavity walls to hermetically close the container 6 inside the housing 2. An optical sensor 71 of the plunger sensing system 70 may be incorporated inside the cap 44 and may be positioned on a transparent sensor window 43. The optical sensor 71 may be mounted on a circuit board 72 that is electrically interconnected with contacts 45 that protrude on the outer surface of the cap for electrically connecting with complementary contacts 45 on the housing 2. Thus, in this embodiment, the container 6 may be mounted inside the housing after assembly of the drive unit 4 and the delivery unit 3, allowing insertion of the container 6 by a patient or a medical professional, as opposed to, for example, being installed at a factory.

[0123] 17a and 17b, yet another embodiment of a drug delivery device is disclosed, which, like the embodiment of Figs. 16a-16d, allows a medical professional or user to insert a drug container 6 after the housing, drive unit and delivery unit are assembled at the factory. In this embodiment, the rear open end of the container casing 38 is closed by a lid 2c, which is hingeably connected to the base 2a of the housing 2 via a hinge connector 46 and includes a container sealing ring 77, which is inserted into and hermetically seals the rear open end of the container casing part 38 when the container is inserted into the container casing part. It is noted that in Figs. 17a and 17b, a portion of the drive unit is not shown to enhance clarity of illustration of the other parts.

[0124] 18a-18d, a drug delivery device according to an embodiment of the present invention advantageously comprises an on-body sensing system 5 electrically connected to the electronic control system 47 of the drive unit 4. The on-body sensing system 5 is based on a capacitive measurement that detects the presence of body tissue in proximity to a capacitive sensor. Capacitive sensors for measuring the proximity of a medical device on the sensor skin are known per se, but conventional sensors are not particularly reliable or costly to incorporate in a drug delivery device. In the present invention, the on-body sensing system 5 comprises an electrode 56 comprising a metal layer formed directly on the inner surface of the contact wall 81 of the housing, and an outer surface of the skin contact wall 81 of the housing configured to be applied to the skin of a patient.

[0125] The electrodes 56 may advantageously be formed by deposition of a metal layer on the inner surface of the housing cover 56, for example by a plating process. The plating process may be a galvanic plating process, but other metal deposition techniques for forming a metallized layer directly on the inner surface of the skin-contacting wall 81 may be utilized within the scope of the present invention. The housing may be made of a thermoplastic or thermosetting polymer and is therefore an insulating material. The electrodes 56 may be connected to the electronic control system 47 of the drive unit 4 via interconnection terminals 61.

[0126] The interconnect terminals 61 may be connected at circuit board connection ends 62 to the circuit board 48 of the electronic control system 47, for example by soldering to circuit traces on the circuit board, and extend to electrode connection ends 63 that contact the metal electrode layer 56. The electrode connection ends 63 may be resiliently supported, for example by being provided at the ends of a spring beam configured to bear against the metal layer of the electrodes 56 when the drive unit 4 is assembled within the housing 2.

[0127] An electronic component such as a microprocessor 49 of the electronic control system 47 may be connected to the electrodes to measure capacitance values, and variations in capacitance values, to detect when the drug delivery device is placed against a patient's skin.

[0128] Activation of the drug delivery device may be configured in the electronic control system 47 such that activation is only possible when the on-body sensing system detects correct position of the drug delivery device on the patient's skin.

[0129] In a first embodiment, an on-body sensing system includes a sensor electrode implemented as a single electrode, and the capacitance between the electrode and a reference potential is measured.

[0130] In a second embodiment, the sensor electrodes can also be implemented as a pair of electrodes 56a, 56b, and the capacitance between them is measured. This has the advantage of reducing false positives due to external factors affecting the capacitance measurement, such as moisture (sweat) at the contact interface, which may be rejected by the measurement system.

[0131] An advantage of the metal layer on the inner surface of the housing 2 is also that it allows for a large surface area to be covered by the electrodes to reliably read the varying capacitance values, allowing for a large capacitive coupling with the patient's skin.

[0132] In a variant, the on-body sensing system can further include a conductive shielding frame 57 surrounding the electrodes to provide some degree of shielding against disturbances from external fields. This shield can also be connected to the electronic control system circuit board 48 using contacts similar to those described above for connecting to the electrode layer. Instead of a metal layer deposited directly on the inner surface of the housing wall that is worn against the patient's skin, the electrodes can also include stamped sheet metal or thin foils of conductive material that are bonded or secured directly to the inner surface of the housing instead of a deposited metal layer. The conductive foil can be bonded, for example by adhesive or welding, to the inner surface of the housing wall 81 to form a stable electrode.

[0133] With reference to Figures 19a-19d, an advantageous method of assembly of a drug delivery device according to an embodiment of the present invention is described. First, with reference to Figure 19a, the manufacture of the components of the drug delivery device that must be sterilized in a reliable manner is disclosed. As shown, a single part for the fluid pack is manufactured and assembled, which corresponds to the liquid flow system 7 and pump system 8 in the casing 9 of the embodiment described above. The container casing shown in Figure 19a corresponds to the container casing 38, which is assembled to the other casing parts once the drug container 6 is inserted therein. The components of the drug container are manufactured separately, and the drug container is assembled to the fluid pack in the container casing under aseptic conditions (in this embodiment according to ISO standard 5). Both the container casing and the fluid pack, in other words the liquid flow system 7, the pump system 8 and the casing 9, can be sterilized with gamma sterilization, which is very reliable in killing all pathogens. Other sterilization methods can also be employed within the scope of the present invention, including chemical and heat sterilization methods, including NO2 (nitrogen dioxide), VHP (vaporized hydrogen peroxide), ETO (ethylene oxide) and steam sterilization methods. The container pack formed from the assembly of these components therefore corresponds to a delivery unit 3 containing all components requiring a very high degree of sterility.

[0134] As mentioned in relation to the previously described embodiment, all outlets of the delivery unit 3 are provided with seals, in particular the sealing membrane 27 covering the reservoir fluid connection system 17, the sealing ring 41 between the reservoir casing 38 and the pump and needle casing 37, and the seal 79 covering the interface between the pump system rotor and the drive coupling interface 33. The sealing membrane 79 may completely cover the drive coupling interface 33, as shown in FIG. 14c, or it may only cover the gap between the rotor and the stator. The sealing membrane 79 may be glued or welded across the interface to form a hermetic seal, or it may be frangible such that the seal ruptures or breaks, for example, when the drive unit is assembled to the delivery unit and actuated during use of the device. In this way, the delivery unit is maintained sterile and has a long shelf life until use of the drug delivery device.

[0135] The manufacture of the fluid pack, container cap and drug container may occur in a single manufacturing facility and be assembled in the same manufacturing facility, as shown in FIG. 19a.

[0136] In a variant, as depicted in Fig. 19b, the fluid cap and container cap may be manufactured in a first manufacturing facility, sterilized, preferably using gamma sterilization similar to the method according to Fig. 19a, and then supplied to a second facility, for example within a pharmaceutical manufacturing company, where the drug containers are manufactured and filled. As mentioned above, other sterilization methods, including chemical and thermal sterilization methods (e.g., NO2, VHP, ETO and steam sterilization methods), may be employed within the scope of the present invention. Thus, the assembly of the drug container, fluid pack and container cap to form the delivery unit 3 may be formed in the second manufacturing site that produces the container pack.

[0137] As shown in Figures 19c and 19d, the sterile container pack representing the delivery unit 3 in an embodiment of the present specification may then be assembled to the electronics representing the drive unit 4 in an embodiment of the present specification, and optionally other non-sterile components, for final assembly of the drug delivery device under controlled conditions, such as ISO9 standards.

[0138] As shown in Fig. 19d, various configurations of manufacturing and assembly at different locations can be implemented. For example, drug container components can be supplied to a drug manufacturer that performs a filling process, and the fluid pack and container cap can be supplied to a pharmaceutical company at a second location for assembling the container to the fluid pack and container cap to form a cartridge pack (i.e., corresponding to the delivery unit 3 of the embodiments described herein). The cartridge pack can then be assembled to the electronic components (i.e., corresponding to the drive unit 4 of the embodiments described herein) and other components can be assembled to the cartridge pack to form a drug delivery device, also at the pharmaceutical company's premises.

[0139] Advantageously, the delivery unit arrangement having a casing 9 housing the liquid flow system 7 and pump system 8 can be sterilised by gamma sterilisation and then assembled to the drug container 6 to form a sealed sterile delivery unit which can then be assembled to non-sterile components such as the electronics and housing components 2 of the drive unit 4. This assembly process provides an efficient manufacturing process and also ensures sterility and safety of the drug delivery device where required.

[0140] in short, - a prefilled medication container, the medication container including a barrel portion and a plunger slidably mounted within the barrel portion to seal the medication within the container; a fluid pack including a fluid flow system providing a fluid connection from a medication container to a patient during a medication delivery action of the medication delivery device; a control unit including electronic components; -Housing; A method for manufacturing a drug delivery device, according to an embodiment of the present invention, comprises the steps of: a) assembling fluid pack components to form said fluid pack; b) sterilizing the fluid pack; c) providing said prefilled medication container; e) assembling the fluid pack to the prefilled medication container to form a container-pack system; f) assembling the reservoir pack system to the control unit and the housing (2) to form a medication delivery device; Steps c) and e) are carried out under sterile conditions.

[0141] In an advantageous embodiment, the medicament container includes a barrel portion and a plunger slidably mounted within the barrel portion to seal the medicament within the container.

[0142] Step a) concerns the assembly of a fluid pack of the drug delivery device. The fluid pack includes at least a liquid flow system that can provide a fluid connection from the prefilled drug container to the patient's body during a drug delivery action of the drug delivery device. The liquid flow system usually consists of different components of different materials. For example, the cannula on the patient side is made of metal, while the fluid pathways are usually made of channels or flexible tubes made of or formed by plastic parts.

[0143] Step b) concerns sterilization of the fluid pack. Since the assembled fluid pack is not usually manufactured under sterile conditions, the fluid pack must be sterilized to ensure that the patient cannula, cartridge needle and the entire fluid pathway are not contaminated. The usual sterilization method to achieve sterility of the assembly depends on the combination of various materials as well as the design of the product (e.g. recesses). Common sterilization methods for fluid packs are gamma irradiation, ethylene oxide (ETO) sterilization, nitrogen dioxide (NO2) sterilization, steam sterilization, vaporized hydrogen peroxide (VHP) sterilization, X-ray sterilization or electron beam sterilization.

[0144] Step c) concerns the provision of a prefilled drug container. The container may be made of glass, polymer, or other materials that are inert with respect to the stability of the drug and preferably biocompatible. Glass is commonly used in commercially available and FDA approved drug containers from many different manufacturers. As a result, there are established and approved procedures for filling and storing drugs aseptically in glass containers, which can accelerate the approval process of drug pump devices that protect the drug in the glass container. Polymer containers, for example made of COP (cycloolefin polymer) or COC (cycloolefin copolymer), may be suitable for certain drugs that degrade more quickly when in contact with glass, such as protein drugs. After filling, the container is closed with a plunger, usually made of a rubber material. The container is filled and closed under aseptic conditions (Class 5 or less of ISO 14644-1).

[0145] Step d) involves assembling the fluid pack with the prefilled medication container to form a reservoir pack system, which may have a fluid connection between the fluid pack and the prefilled medication container, or the connection may be established separately, for example after manufacture or immediately prior to medication delivery to a patient.

[0146] Step e) involves assembling the container pack system to the control unit and the housing (2) to form the drug delivery device. The assembly of the control unit to the user interface of the container pack system as well as the attachment of the housing can be achieved by standard form-fit connections or any other conventional manufacturing method. To achieve a water-tight or even gas-tight housing, this can also include welding or gluing processes.

[0147] Definition of aseptic conditions: Aseptic conditions ensure that the filling and assembly environment is free of pathogens such as bacteria, viruses, and other microorganisms that can cause disease, in addition to having a low particle count.

[0148] Sterile conditions can be achieved, for example, in a class 5 cleanroom according to ISO 14644-1, or in a lower class number cleanroom (ie, with higher standards).

[0149] An alternative definition of aseptic conditions can be found in the United States Pharmacopoeia (USP) Chapter 1116, Microbiological Control and Monitoring of Aseptic Processing Environments.

[0150] Further definitions of sterile conditions can be found in DIN EN ISO 13408-1 Aseptic processing of healthcare products - Part 1: General requirements.

[0151] In an advantageous embodiment of the method, step e) is not performed under sterile conditions. Electronic components are very sensitive to common sterilization methods such as gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization or electron beam sterilization. By performing step e) under non-sterile conditions, destruction of the electronic components is avoided. Thus, the assembly of the drug delivery device is performed without risk of destruction of the components, and safety for the patient is guaranteed. Therefore, further, the manufacturing method of step e) is not limited to particle-free or low particle emission joining techniques.

[0152] In an advantageous embodiment of the method, the container pack system includes a container casing that encloses the prefilled drug container. The container casing can be connected to a fluid pack so that the prefilled drug container can be kept sterile in a simple manner. The container can be in direct fluid communication with the liquid flow system, or the fluid pack includes a means for separately connecting the prefilled drug container to the liquid flow system, for example after manufacture or immediately before delivery of the drug to the patient.

[0153] In an advantageous embodiment of the method, the container pack system includes a pump system configured to cause the plunger to be further depressed within the prefilled container to administer the medication, in an advantageous embodiment, the pump system effects the medication delivery by drawing in ambient air and injecting it into the container casing.

[0154] In an advantageous embodiment of this method, the pump system includes a coupling interface of the pump system of the delivery unit, the pump drive providing torque to the rotor of the pump system, and the coupling interface being sealed by a sealing membrane to maintain sterility after step b). The seal can be made of a thermoplastic elastomer (TPE) in a two-component mold or of a separate TPE or elastomer that seals against the moving coupling interface. The seal can also be made to completely cover the coupling interface and break within the first rotation of the coupler. In this case, the seal can consist of a polyethylene foil (e.g. Tyvek™ foil) rather than an elastomeric material.

[0155] In an advantageous embodiment of the method, the housing includes a user interface, which may include electronic components that are highly sensitive to common sterilization procedures.

[0156] In an advantageous embodiment of this method, the sterilization method in b) is either gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization or electron beam sterilization.

[0157] [List of features] Drugs 78 Drug delivery device 1 Housing 2 base 2a Cover 2b Skin contact wall 81 Needle Orifice 10 adhesive layer Protective film 11 Lid 2c Container sealing ring 77 Hinge connector 46 Delivery Unit 3 Medicine container 6 Barrel part 6a Neck part 6b bulkhead 6c Plunger 12 Plunger rear end 73 Liquid Flow System 7 Subcutaneous Delivery System13 conduit 14 syringe needle 15 Needle support (slidable) 16 Housing Slide 67 Receptacle fluid connection system 17 septum needle 18 Septum needle support 19 Flange Section 20 Gap / Cavity (for block finger release) 21 Guide 22 Spring 23 Conical Spring Blocks 24 Support ring (rotatable) 25 Block Finger 26 Sealing membrane 27 Operating lever 64 Support ring 66 Lever Arm 65 Pump System 8 Pump engine 28 Stator 29 Fluid inlet 30 Fluid outlet 31 Rotor 32 Drive connection interface 33 Working disk 34 Hollow 35 Pump shaft 36 seal Pneumatic Flow System 74 Casing 9 Pump and needle system casing 37 Needle Exit Orifice 68 Container casing 38 Container receiving cavity 75 tubular part 39 Bulkhead end 40 Sealing ring 41 Plunger end portion 42 Sensor window 43 Sensor prism 43' Cap 44 Electrical Contact Interface 45 Control unit or drive unit 4 Electronic Control System 47 Circuit Board 48 Microprocessor 49 Wireless Connection Module Power supply (battery) 50 Pump drive unit 52 Motor 53 Connection interface 54 Spring 69 User Interface 55 Plunger Sensing System 70 Circuit Board 72 Optical Sensor 71 Transmitter 71 Receiver 71b Prism 43', Window 43 Electrical Contact Interface 45 On-body sensing system 5 electrode 56 metallization layer Shield 57 Processing circuit 58 Circuit Board 59 Microprocessor 60 Interconnect terminal 61 Circuit board connection end 62 Electrode connection end 63 Spring beam

[0158] [Embodiment] (1) A method of manufacturing a drug delivery device, the drug delivery device comprising: A prefilled medication container (6); a fluid pack including a fluid flow system (7) providing a fluid connection from the drug container to a patient during a drug delivery action of the drug delivery device; a drive unit including electronic components and a pump drive (52); A housing (2), The method includes the steps of: a) assembling components of the fluid pack to form the fluid pack; b) sterilizing the fluid pack; c) providing said prefilled medication container; d) assembling the sterilized fluid pack to the prefilled medication container to form a container pack system; e) assembling the container pack system to the drive unit and the housing (2) to form the medication delivery device, the fluid pack includes a container casing (9) for receiving the prefilled medication container (6) therein, a pump engine (28) having a rotor (32) including a connection interface (33) configured to connect to the pump drive (52) for providing torque to the rotor, the connection interface being sealed by a sealing membrane (79) to maintain sterility after step b); and The method, wherein steps c) and d) are carried out under sterile conditions. (2) The method of embodiment 1, wherein step e) is not performed under sterile conditions. (3) The method of embodiment 1, wherein the medicament container comprises a barrel portion (6a) and a plunger (12) slidably mounted within the barrel portion to seal the medicament (78) within the container. (4) The method of embodiment 1, wherein the sealing membrane is made of a thermoplastic elastomer (TPE), either in a two-component molding with the housing or as a separately assembled component. (5) The method of embodiment 1, wherein the sealing membrane is made of a polyethylene foil covering the connection interface.

[0159] (6) The method of claim 1, wherein the sealing membrane is configured to be ruptured upon activation of the pump drive. (7) The method of claim 1, wherein the housing includes a user interface (55). (8) The method according to embodiment 1, wherein the sterilization method in (b) is any one of gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization, and electron beam sterilization. (9) The method of embodiment 1, wherein the assembly step of step d) includes a form-fit connection. (10) The method of embodiment 9, wherein the form-fit connection provides a hermetic seal of the prefilled medication container within the container pack system.

[0160] (11) The drug delivery device comprises: a delivery unit (3) including the drug container (6), the liquid flow system (7), the pump system (8) including the pump engine (28), and the casing (9) enclosing the drug container, the pump system, and the liquid flow system therein; The drive unit (4), a housing (2) in which the delivery unit and the drive unit are mounted; Including, the delivery unit without the medicament container assembled therein forms the fluid pack, and the delivery unit with the medicament container assembled therein forms the reservoir pack; 2. The method of claim 1, wherein the drive unit includes an electronic control system (47) and a power source (50). (12) The method according to embodiment 11, wherein the drug container is accommodated within a container receiving cavity (75) of the container casing portion (38) of the casing (9), the container receiving cavity being fluidly interconnected in a gas-tight manner to a fluid outlet (31) of the pump system (8), the pump system including a fluid inlet (30) connected to ambient air, the pump system being configured to pump ambient air taken in through the fluid inlet (30) into the container receiving cavity (75), thereby exerting pressure on the rear end (73) of the plunger for delivery of the liquid drug. (13) The method of claim 11, wherein the fluid flow system (7) of the delivery system (3) comprises a container fluid connection system (17) including a septum needle (18) mounted on a movable septum needle support (19), a spring (23) urging the septum needle support towards the septum of the drug container, and a blocking device (24) movable from a blocked position, in which the septum needle (18) is not in contact with the septum (6c) and the septum needle support (19) is held in a retracted position behind a sterile barrier seal (27) of the casing (9), to an actuated position, in which the septum needle support is released and allowed to move towards the septum of the drug container such that the septum needle (18) pierces the sterile barrier seal (27) and the septum (6c), under the force of the spring (23). (14) The method of embodiment 11, related to embodiment 3, wherein the control unit includes an electronic control system (47) and a plunger sensing system (70) including an optical sensor (71) including a transmitter (71a) and a receiver (71b), the transmitter configured to transmit an optical signal to a rear end (73) of the plunger (12), the receiver configured to receive the optical signal reflected from the rear end (73) of the plunger, and the plunger sensing system connected to the electronic control system (47) is configured to measure a time of flight of the optical signal from the transmitter to the receiver and determine therefrom a position of the plunger within the cylindrical portion of the drug container. (15) The control unit includes an on-body sensing system (5) including an electrode (56) connected to an electronic control system (47) of the control unit for measuring capacitance values ​​configured to detect whether the drug delivery device is positioned against the skin of a patient, and the skin contact wall (81) of the housing (2) has an inner side facing the inside of the housing to which the delivery unit and the control unit are attached, and an outer attachment side facing the outside of the housing and intended to be applied to the skin of a patient, 12. The method of claim 11, wherein the electrode (56) comprises a layer of metal attached directly to the inner side of the skin-contacting wall.

Claims

1. 1. A method of manufacturing a drug delivery device, the drug delivery device comprising: A prefilled medication container (6); a fluid pack including a liquid flow system (7) providing a fluid connection from the prefilled medication container to a patient during a medication delivery action of the medication delivery device; a drive unit including electronic components and a pump drive (52); A housing (2), The method includes the steps of: a) assembling components of the fluid pack to form the fluid pack; b) sterilizing the fluid pack; c) providing said prefilled medication container; d) assembling the sterilized fluid pack to the prefilled medication container to form a container pack system; e) assembling the container pack system to the drive unit and the housing (2) to form the medication delivery device, the fluid pack includes a casing (9) for receiving the prefilled drug container (6) therein, a pump engine (28) having a rotor (32) including a connection interface (33) configured to connect to the pump drive (52) for providing torque to the rotor, the connection interface being sealed by a sealing membrane (79) to maintain sterility after step b); Steps c) and d) are carried out under sterile conditions.

2. 10. The method of claim 1, wherein step e) is not performed under sterile conditions.

3. 2. The method of claim 1, wherein the prefilled medication container includes a barrel portion (6a) and a plunger (12) slidably mounted within the barrel portion to seal a medication (78) within the prefilled medication container.

4. The method of claim 1 , wherein the sealing membrane is made of a thermoplastic elastomer (TPE), either in a two-component mold with the housing or as a separately assembled component.

5. The method of claim 1 , wherein the sealing membrane is made of polyethylene foil covering the connection interface.

6. The method of claim 1 , wherein the sealing membrane is configured to be ruptured upon activation of the pump drive.

7. The method of claim 1 , wherein the housing includes a user interface (55).

8. 2. The method of claim 1, wherein the sterilization method in b) is any one of gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization, and electron beam sterilization.

9. The method of claim 1 , wherein the assembly step of step d) comprises a form-fit connection.

10. 10. The method of claim 9, wherein the form-fit connection provides a hermetic closure of the prefilled medication container within the container pack system.

11. The drug delivery device comprises: a delivery unit (3) including the prefilled drug container (6), the liquid flow system (7), a pump system (8) including the pump engine (28), and the casing (9) enclosing the prefilled drug container, the pump system, and the liquid flow system therein; The drive unit (4), the housing (2) in which the delivery unit and the drive unit are mounted; Including, The delivery unit without the prefilled medication container assembled therein forms the fluid pack, and the delivery unit with the prefilled medication container assembled therein forms the container pack system; The method of claim 1 , wherein the drive unit includes an electronic control system (47) and a power source (50).

12. The prefilled drug container includes a barrel portion (6a) and a plunger (12) slidably mounted within the barrel portion to seal a drug (78) within the prefilled drug container; 12. The method according to claim 11, wherein the prefilled medicament container is accommodated inside a container receiving cavity (75) of a container casing portion (38) of the casing (9), the container receiving cavity being fluidly interconnected in a gas-tight manner to a fluid outlet (31) of the pump system (8), the pump system including a fluid inlet (30) connected to ambient air, the pump system being configured to pump ambient air taken in through the fluid inlet (30) into the container receiving cavity (75) and thus apply pressure to the rear end (73) of the plunger for delivery of the medicament (78).

13. 12. The method of claim 11, wherein the liquid flow system (7) of the delivery system (3) comprises a container fluid connection system (17) including a septum needle (18) mounted on a movable septum needle support (19), a spring (23) that urges the septum needle support towards the septum of the prefilled medication container, and a blocking device (24) that is movable from a blocked position, in which the septum needle (18) is not in contact with the septum (6c) and the septum needle support (19) is held in a retracted position behind a sterile barrier seal (27) of the casing (9), to an actuated position, in which the septum needle support is released and allowed to move towards the septum of the prefilled medication container such that the septum needle (18) pierces the sterile barrier seal (27) and the septum (6c) under the force of the spring (23).

14. The prefilled drug container includes a barrel portion (6a) and a plunger (12) slidably mounted within the barrel portion to seal a drug (78) within the prefilled drug container; 12. The method of claim 11, wherein the drive unit comprises the electronic control system (47) and a plunger sensing system (70) including an optical sensor (71) including a transmitter (71a) and a receiver (71b), the transmitter configured to transmit an optical signal to a rear end (73) of the plunger (12) and the receiver configured to receive the optical signal reflected from the rear end (73) of the plunger, and the plunger sensing system connected to the electronic control system (47) is configured to measure a time of flight of the optical signal from the transmitter to the receiver and determine therefrom a position of the plunger within the barrel portion (6a) of the prefilled medication container.

15. The drive unit includes an on-body sensing system (5) including an electrode (56) connected to the electronic control system (47) of the drive unit for measuring a capacitance value configured to detect whether the drug delivery device is positioned against the patient's skin, and the skin-contacting wall (81) of the housing (2) has an inner side facing the inside of the housing to which the delivery unit and the drive unit are attached, and an outer attachment side facing the outside of the housing and intended to be applied to the patient's skin, The method of claim 11 , wherein the electrode (56) comprises a layer of metal mounted directly against the inner side of the skin-contacting wall.

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