Drug Delivery Devices

Abstract

A drug delivery device (1) comprising a housing (2), a delivery unit (3) including a drug reservoir (6), and a control unit (4) mounted inside the housing (2), the control unit including 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, the skin-contacting wall (81) of the housing (2) having 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 against the skin of a patient. The electrode (56) comprises a layer of metal mounted directly against the inner side of the skin-contacting wall.

Description

[Technical Field]

[0001] The present invention relates to a drug delivery device for the subcutaneous administration of a liquid drug, and in particular to 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 a patient's skin for subcutaneous delivery of liquid medication are known. Some devices typically have an internal reservoir that receives a cartridge or is filled by the patient / healthcare professional. In this case, the medication is drawn from a vial and transferred into the internal reservoir using a syringe. Because cartridges are widespread and very easy to handle, it would be advantageous to provide a device that can be used with standard cartridges. The liquid medication can be, for example, a biological pharmaceutical product or other medication that is simply administered for a one-shot administration within a somewhat short period of 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 consequently the cost of the disposable device, are also important considerations.

[0004] To meet safety and reliability requirements, many conventional patch pump drug delivery devices have complex pump mechanisms and are quite bulky, and long shelf life and proper sterilization are often difficult to achieve, increasing manufacturing costs.

[0005] For the safety of use of drug delivery devices, it is also important to ensure that the device can only be activated when attached to the patient's skin and that the device remains sterile until the administration of the drug. Summary of the Invention [Problem to be solved by the invention]

[0006] In view of the above, it is an object of the present invention to provide a drug delivery device, in particular in the form of a patch device, with a disposable unit or as a completely disposable device, for the administration of liquid drugs, which is safe, reliable and compact.

[0007] It would be advantageous to provide a medication delivery device that can be used to administer a liquid medication provided in a medication container with a plunger.

[0008] It would be advantageous to provide a drug delivery device that is easy to use.

[0009] It would be advantageous to provide a drug delivery device that is economical to manufacture.

[0010] It would be advantageous to provide a drug delivery device that has a long shelf life. [Means for solving the problem]

[0011] The object of the present invention has been achieved by providing a drug delivery device as claimed in claim 1.

[0012] Disclosed herein, according to a first aspect of the present invention, is a medication delivery device comprising a housing, a delivery unit including a medication container, and a control unit mounted within 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 medication delivery device is positioned against a patient's skin. The skin-contacting wall of the housing has an inner side facing the inside of the housing to 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 patient's skin. The electrode includes a metal layer mounted directly against the inner side of the skin-contacting wall.

[0013] 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.

[0014] In an advantageous embodiment, the directly deposited metal layer is a galvanic plated layer.

[0015] In an advantageous embodiment, the on-body sensing system further includes a shield in the form of a conductor surrounding the electrode.

[0016] In an advantageous embodiment, the on-body sensing system is configured to measure a capacitance value between said electrode and a ground value.

[0017] In an advantageous embodiment, the on-body sensing system includes a second electrode insulatingly 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.

[0018] In an advantageous embodiment, the second electrode is formed as a metal layer directly on the inner side of the mounting wall.

[0019] In an advantageous embodiment, the second electrode is formed as a metal layer, just like the first electrode.

[0020] In an advantageous embodiment, the second electrode and the first electrode have interleaved portions.

[0021] In an advantageous embodiment, the metal electrode layer consists of a sheet metal plate stamped out of sheet metal, and the electrodes are assembled on the inner side of the skin-contacting wall.

[0022] In an advantageous embodiment, the electrodes are integrally formed with the sheet metal plate and include interconnection terminals rising therefrom to the circuit board connection ends.

[0023] In an advantageous embodiment, the adhesive layer contains silver ions or silver nanoparticles (AgNPs) as antimicrobial agents.

[0024] Disclosed herein, according to a second aspect of the present invention, is a medication delivery device including a delivery unit including a medication container, a liquid flow system, a pump system, and a casing enclosing at least a portion of the medication container, the pump system, and the liquid flow system. The medication container includes a barrel portion and a plunger slidably mounted within the barrel portion and sealing the medication within the container at one end of the barrel portion, and the liquid flow system is fluidly connected to the medication container during delivery of the liquid medication. The medication container is accommodated within a container-receiving cavity in the 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 is configured to pump ambient air taken in through the fluid inlet into the container-receiving cavity, thereby applying pressure to a rear end of the plunger for delivery of the liquid medication.

[0025] 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 greater than the first diameter; and a first valve formed by a first valve seal mounted on the stator about the first axial extension, the first valve 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, the second valve 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.

[0026] In an advantageous embodiment, the medication container is a medication cartridge.

[0027] Disclosed herein, according to a third aspect of the present invention, is a method for producing a medicament for use in a medicament for the treatment of a malaria parathyroidectomy (MSA) 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, wherein the transmitter is configured to transmit an optical signal to a rear end of the plunger, and the receiver is configured to receive the optical signal reflected from the rear end of the plunger, and the plunger sensing system connected to the electronic control system is configured to measure a time of flight of the optical signal from the transmitter to the receiver and determine a position of the plunger within the cylindrical portion of the medication container therefrom; A drug delivery device comprising:

[0028] 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 being positioned on or adjacent to the sensor window, the transmitter being configured to transmit the optical signal through the sensor window to the rear end of the plunger, and the receiver being configured to receive the optical signal reflected from the rear end of the plunger and returning through the sensor window.

[0029] 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 its initial position.

[0030] In one embodiment, the distance from the rear end of the plunger is in the range of 5 mm to 20 mm.

[0031] In one embodiment, the delivery unit includes a casing including a container casing portion including a plunger end portion that covers 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 being positioned on or adjacent to the face of the sensor prism, the transmitter being configured to transmit the optical signal through the sensor prism to the rear end of the plunger, and the receiver being configured to receive the optical signal reflected from the rear end of the plunger and returning through the sensor prism.

[0032] 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.

[0033] Disclosed herein, according to a fourth aspect of the present invention, is a medication delivery device including a delivery unit including a medication container, a liquid flow system, a pressurized gas source, and a casing enclosing at least a portion of the medication container, the pressurized gas source, and the liquid flow system. The medication container includes a barrel portion and a plunger slidably mounted within the barrel portion and sealing the medication within the container at one end of the barrel portion. The medication container is accommodated within a container-receiving cavity in the container-casing portion of the casing, and the container-receiving cavity is 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 applying pressure to a rear end of the plunger for delivery of the liquid medication. 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 the position of the plunger over time from the pressure measurements 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.

[0034] In an advantageous embodiment, the pressurized gas source includes a pump system configured to pump gas into the container receiving cavity, thereby applying pressure to the rear end of the plunger.

[0035] In an advantageous embodiment, the pump system is configured to pump ambient air into the container receiving cavity, thereby exerting pressure on the rear end of the plunger.

[0036] Disclosed herein, according to a fifth aspect of the present invention, 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 toward the septum of the medication container, and a blocking organ movable from a blocked 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 toward the septum of the medication container under the force of the spring so that the septum needle penetrates the septum.

[0037] 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 and 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 penetrates the septum.

[0038] In an advantageous embodiment, the septum needle support includes flange sections and gaps between the flange sections, and the blocking fingers engage the flange sections during a blocking position in which the septum needle support is retracted.

[0039] In an advantageous embodiment, the septum needle support includes guides on opposing portions that engage complementary guide portions in the casing to slidably guide the septum needle support from the retracted position to the septum-piercing position.

[0040] In an advantageous embodiment, the injection delivery system includes a needle actuation mechanism configured to move the injection needle from a retracted position within the 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.

[0041] In an advantageous embodiment, the actuation disc is directly connected to or is formed integrally with the rotor of the pump engine of the pump system.

[0042] 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.

[0043] In an advantageous embodiment, the actuation lever comprises a support ring mounted around a shroud portion of the casing that surrounds a cavity that receives the septum end of the medicament container therein.

[0044] 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.

[0045] Disclosed herein, according to a sixth aspect of the present invention, is a method of manufacturing a drug delivery device, the drug delivery device comprising: a pre-filled 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 that provides 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; 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; e) assembling the fluid pack to the prefilled medication container to form a container-pack system; f) assembling the container pack system to the control unit and the housing (2) to form a medication delivery device; Steps c) and e) are characterized in that they are carried out under sterile conditions.

[0046] In an advantageous embodiment of this method, step f) is not carried out under sterile conditions.

[0047] In an advantageous embodiment of the method, the cartridge pack system includes a container casing that encloses the pre-filled medication container.

[0048] In an advantageous embodiment of the method, the container pack system comprises a pump system.

[0049] In an advantageous embodiment of this method, the pump system comprises a connection interface of the pump system of the delivery unit, the pump drive providing torque to the rotor of the pump system, and the connection interface being sealed by a sealing membrane to maintain sterility after step b).

[0050] In an advantageous embodiment of the method, the housing includes a user interface.

[0051] In an advantageous embodiment of this method, the sterilization method in b) is one of gamma irradiation, ETO sterilization, NO2 sterilization, steam sterilization, VHP sterilization, X-ray sterilization or electron beam sterilization.

[0052] In an advantageous embodiment of the method, the assembly step of step e) comprises a form-fit connection.

[0053] In an advantageous embodiment of the method, the form-fit connection provides a hermetic closure of the pre-filled medication container within the container-pack system.

[0054] In an embodiment of this method, a delivery unit as described herein 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 unit including electronic components.

[0055] In this method embodiment, the drug delivery device can have any one or more additional features of any of the device embodiments described herein.

[0056] In various embodiments, the drug container can include a septum at one end of the drug container, the septum being pierced by a septum needle fluidly connected to the injection needle during actuation of the drug delivery device.

[0057] In various embodiments, the medication 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 within the housing, to an activated position in which the needle tip protrudes from the skin-contacting wall of the housing for injection delivery of a liquid medication.

[0058] In various embodiments, the liquid flow system may include an injection delivery system including an injection needle mounted on a movable needle support connected via a conduit to a container fluid connection system including a septum needle.

[0059] In various embodiments, the medication 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.

[0060] 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 worn against the patient's skin, the skin-contacting wall including an adhesive patch with a protective film. The adhesive may contain silver ions or silver nanoparticles (AgNPs) as an antimicrobial agent.

[0061] In various embodiments, for certain medical applications, the medication delivery device may be configured as a single-use, disposable device, and may be configured specifically for a single administration of a liquid medication contained within a container.

[0062] Further objects and advantageous features of the present invention will become apparent from the appended claims, detailed description and accompanying drawings. [Brief explanation of the drawings]

[0063] [Figure 1a] 1 is a perspective view of a medication delivery device according to an embodiment of the present invention; [Figure 1b] 1b is a perspective view of the device of FIG. 1a with the cover and adhesive with protective film disassembled. [Figure 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] 1 is a perspective cross-sectional view of a dispensing unit according to an embodiment of the present invention. [Figure 3c] 1 is a perspective cross-sectional view of a dispensing unit according to an embodiment of the present invention. [Figure 4a] 1 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] 4b is a perspective exploded view of the liquid flow pump system of FIG. 4a. [Figure 4c]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] 1A-1C are cross-sectional views 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 the needles of the transdermal delivery system and the needles of the reservoir fluid connection system when the drug delivery device is actuated. [Figure 5c] 1A-1C are cross-sectional views 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 the needles of the transdermal delivery system and the needles of the reservoir fluid connection system when the drug delivery device is actuated. [Figure 5d] 1A-1C are cross-sectional views 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 the needles of the transdermal delivery system and the needles of the reservoir fluid connection system when the drug delivery device is actuated. [Figure 5e] 1A-1C are cross-sectional views 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 the needles of the transdermal delivery system and the needles of the reservoir fluid connection system when the drug delivery device is actuated. [Figure 6a] 5b is a perspective view of the device of FIG. 5a in an initial position corresponding to FIG. 5a (with outer housing parts removed for better visibility inside); FIG. [Figure 6b] FIG. 6b is a view similar to FIG. 6a, showing an intermediate actuation position corresponding to FIG. 5c; [Figure 6c] 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. 6d is a view similar to FIG. 6d, showing the 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, showing the end position with both needles fully inserted. [Figure 7a] 7a is a perspective cross-sectional view taken along line 7a-7a of FIG. 5a. [Figure 7b] FIG. 7b is a cross-sectional view taken along line 7b-7b of FIG. 5e. [Figure 8a] 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] 9a is a cross-sectional view taken along line 9a-9a of FIG. 5a. [Figure 9b] FIG. 9 is a cross-sectional view taken along line 9b-9b of FIG. 5e. [Figure 10a] 1 is a perspective exploded view of a drive unit of a medication delivery device according to an embodiment of the present invention; [Figure 10b] 1 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 disengaged state with 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] A perspective view of a medication delivery device according to an embodiment of the present invention with the housing removed, showing the delivery unit and drive unit assembled, and also showing a schematic representation 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. 11a. [Figure 12b] 12b is a cross-sectional view taken along line 12b-12b of FIG. 12a. [Figure 13] FIG. 1 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. 10 is a perspective view of a second embodiment of a sealing interface. [Figure 15a] 1 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. 10 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] FIG. 10 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] 10 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] 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. FIG. [Figure 16c] 16b 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] 10 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. 1 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, showing 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 18e] FIG. 18c is a perspective view of a drive unit of a medication delivery device according to a variation of the embodiment of FIG. 18b. [Figure 18f] FIG. 18e is a perspective view of the housing cover of the embodiment of FIG. [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] 10A-10C are schematic diagrams of another embodiment of the assembly and sterilization steps of a medication delivery device according to another embodiment of the present invention. [Figure 19c] 10A-10C are schematic diagrams of another embodiment of the assembly and sterilization steps of a medication delivery device according to another embodiment of the present invention. [Figure 19d] 10A-10C are schematic diagrams of another embodiment of the assembly and sterilization steps of a medication delivery device according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0064] 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.

[0065] In the illustrated embodiment, the drug delivery device 1 is a single-use, disposable unit for subcutaneous administration of a liquid medication (drug). Administration can 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 can also be used for subcutaneous injection of a liquid medication over an extended period of time, from several hours to several days, or even up to one to three weeks. Depending on the amount of medication to be injected, the drug delivery device can also be configured to inject the liquid medication within minutes.

[0066] There are various applications in which it would be advantageous to provide a patient in need of medication with a drug delivery device that the patient can wear on their body or that the patient can apply directly to their skin before use to inject the medication outside of a hospital or medical facility, for example, at home. In certain medical applications, there may also be a need to deliver a liquid medication within a range of time after an event such as a surgical intervention or other form of treatment at a hospital or clinic, for example, once the patient returns home. In other applications, it would be advantageous to provide the patient with a drug delivery device for injecting a medication at a specific time, for example, once a week or once a month, or at various other intervals depending on the medication and treatment, so that the patient can perform the treatment at home, for example, without having to have the medication administered by a medical professional in a clinical setting.

[0067] Although the illustrated embodiment relates to a single-use disposable medication delivery device, it is within the scope of the present invention in various aspects described herein to use a medication delivery device having a disposable part that can be assembled to a reusable part that includes a drive unit, electronics, and power source. The delivery unit 3 can be mounted in a housing of the medication delivery device, and the drive unit 4 can be mounted in a separable housing part, and the drive unit 4 can be reused in subsequent delivery units. Examples of medication delivery devices with single-use disposable and reusable parts are described, for example, in WO2020109409.

[0068] The medication delivery device includes a user interface 55 which may include one or more buttons for activating 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.

[0069] A drug delivery device according to an embodiment of the present invention may advantageously be configured as a patch device for attachment to a patient's skin. 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 that can be peeled off from the adhesive layer before applying it to the patient's skin at the injection site. The adhesive may contain silver ions or silver nanoparticles (AgNPs) as an antibacterial agent. A needle orifice 10 through the skin-contacting wall 81 is covered with a protective film 11 before use, allowing a transdermal injection needle 15 to extend through the needle orifice and pierce the patient's skin upon activation of the drug delivery device 1.

[0070] 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.

[0071] In embodiments, 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.

[0072] 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 a liquid drug 78 to be administered to a patient being sealed within the barrel portion 6a between the plunger and the septum. Such drug containers 6 are well known in the pharmaceutical industry and can be used to sterilely contain many different types of liquid drugs. It is understood that such drugs may also be provided in different sizes (volumes), and drug delivery devices according to embodiments of the present invention may be sized to accommodate different types of drug containers depending on the medical application. Embodiments of the present invention may also be used with non-standard drug containers.

[0073] It should be noted that while certain embodiments of the invention disclosed herein require a drug container including a sliding plunger, certain other embodiments of the invention disclosed herein are not limited to use with drug containers having plungers and may be used with other forms of drug containers lacking plungers. For example, the on-body sensing system, as described below, is independent of the type of drug container used in the drug delivery device. Also, for example, the container fluid connection system 17, as described below, requires a drug container having a pierceable sterility barrier, but does not necessarily require a drug container having a plunger. Furthermore, the method of manufacturing the drug delivery device, as described below, is independent of the type of drug container used in the drug delivery device.

[0074] The delivery unit 3 incorporates a pump system 8 that, when the drug delivery device is activated, drives liquid from the reservoir into the injection needle 15. The pump system includes a drive coupling interface 33 that couples to a coupling interface 54 of a pump drive 52 of the drive unit 4. The drive unit therefore provides mechanical power via couplings 54, 33 to drive the pump system 8.

[0075] The pump engine 28 may advantageously comprise a design and configuration similar to that of the pump engines described in WO2007074363 or WO2015015379, in which a rotor 32 is mounted within a stator 29 and is rotatably and axially removable therein for pumping 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 the fluid channel between the inlet and outlet as the rotor rotates and is displaced axially by a cam mechanism between the stator and the rotor, thereby providing pumping action during opening and closing of valves between the fluid inlet and pump chamber or between the pump chamber and outlet.

[0076] 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 axially extending portion having a first diameter and a second axially extending portion having a second diameter greater than the first diameter; a first valve formed by a first valve seal mounted on the stator about the first axial extension, the first valve 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 around the second axial extension, the second valve 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.

[0077] 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 advantageously be used to pump air, which creates pressure against the container plunger to displace the plunger and force the liquid out of the container when the septum is pierced.

[0078] In advantageous embodiments of the present invention, particularly for single use and single injections of the contents of the medication container over a period of time ranging from a few minutes to 60 minutes, for example, the pump engine may be used to pump air, which creates pressure on the plunger 12 to advance the plunger toward the septum and force the 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 that generates air pressure within at least a portion of the casing 9 behind the plunger 12, as best shown in FIG.

[0079] An important advantage of using such a pump engine in embodiments of the drug delivery device of the present invention is that there is no direct fluid connection between the inlet and outlet at any position of the rotor, and no valve actuation is required, thus ensuring particularly reliable gas delivery without leakage and in an easily operable 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 operate optimally with a given type of electric motor rotating at a constant speed. Furthermore, the pump engine components can be made entirely of polymeric materials, and the rotor can be easily coupled to the pump drive, ensuring a sterile barrier between the fluid parts of the pump engine and the coupling interface.

[0080] It should be noted that certain aspects of the embodiments of the invention described herein do not necessarily rely 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 may 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 a container. Also, the container fluid connection system 17, described in more detail below, may be implemented with a different pump system, for example, a pneumatic drive, or a drive that mechanically pushes a plunger as known per se, or by aspirating liquid using the engine described in WO2015015379.

[0081] 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 and receiving data to and from external devices via a wireless communication link, for example using Bluetooth.

[0082] 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.

[0083] 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 that urges the motor drive coupling interface 54 against the coupling interface 33 of the pump engine rotor 32, as best shown in Figures 10a-10c.

[0084] 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 medication delivery device and to identify, for example, an occlusion in the fluid flow system or the end of plunger movement when the medication reservoir is emptied at the end of the medication administration process. Embodiments of the plunger sensing system 70 are described in more detail below.

[0085] 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 medication delivery systems having a medication 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 medication.

[0086] The drive unit may further include an on-body sensing system 5 for detecting whether the medication delivery device is positioned against the patient's skin. The on-body sensing system prevents operation of the medication delivery device if it is not positioned against the patient's skin and can also detect if the medication delivery device is removed before complete delivery of the medication. Embodiments of the on-body sensing system 5 are described in more detail below.

[0087] The fluid flow system 7 includes a subcutaneous delivery system 13 including an injection needle 15 for penetrating the patient's skin, and a reservoir fluid connection system 17 including a septum needle 18 for penetrating the 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.

[0088] 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 that allows sliding movement of the needle support from a retracted position to an extended position, the other end of which is connected to a container fluid connection system 17.

[0089] The container fluid connection system 17 includes a septum needle support 19 to which a septum needle 18 is attached, 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 within 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 within the container.

[0090] In an advantageous embodiment, the reservoir fluid connection system 17 may be activated simultaneously with the subcutaneous delivery system 13. However, it should be noted that within the scope of the present invention, the reservoir fluid connection system 17 may be activated prior to, for example sequentially, activation of the subcutaneous delivery system 13. The step of first connecting the septum needle 18 with the medication liquid before penetrating the patient's skin with the injection needle 15 may allow the fluid connection, including the conduit 14, to be filled with medication prior to injection in order to remove air from the fluid channel prior to injection.

[0091] In an advantageous embodiment, the container fluid connection system 17 includes a slidable needle support 19 having a flange section 20 with a guide 22 at its outer end that slidably engages a complementary guide within 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, in which the septum needle support 19 is in the retracted position as shown in FIGS. 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 toward the drug container and through the closure member 27 (sterility barrier) and the septum 6c. Other forms of springs may also be provided within the scope of the present invention. Blocking finger 26 can be disengaged from engagement with the septum needle support, for example by being moved into the gap between flange sections 20, causing spring 23 to urge the septum needle support toward sealing member 27 and septum 6c, with septum needle 18 penetrating the sealing member and septum.

[0092] The blocking device 24 may, in an advantageous embodiment, include a rotatable support ring 25 from which projecting blocking fingers 26. The rotatable support ring 25 is fitted around a shroud that forms a cavity into which a container cap with, for example, a septum 6c is inserted.

[0093] 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.

[0094] In an advantageous embodiment, movement of the blocking finger 26 and its release from the septum needle support 19 can be accomplished by actuation of the pump engine 28 of the pump system 8. The subcutaneous delivery system 13 can also be simultaneously actuated by initial rotation of the rotor 32 of the pump engine 28.

[0095] 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 distal end of a lever arm 65 connected to a support ring 66 of an actuation lever 64. As best seen in FIGS. 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 distal end configured to engage the recess 35 of the actuation disk 34 when the rotor 32 is rotated by the pump drive 52 of the drive unit 4.

[0096] As can be seen in Figures 5a and 6a, the initial position of the medication delivery device prior to first use is shown, in which the tip of the lever arm 65 rests against the outer circumferential surface of the actuation disc 34. Upon actuation of the medication delivery device, when pumping action is initiated, the actuation disc 34 rotates (counterclockwise 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 (clockwise 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 (clockwise as shown in Figures 5b-5d) so that its block finger 26 disengages the septum needle support 19.

[0097] Thus, in the advantageous embodiment described above, actuation of the pump drive automatically and simultaneously activates both the subcutaneous delivery system 13 and the container full connection system 17 for administration of the medication. This simultaneous activation upon start-up of the pump system has the advantage of ensuring hermetic containment of the medication within the container until administration to the patient, thereby improving sterility and shelf life.

[0098] 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 18 before the septum needle penetrates the container septum.

[0099] The 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.

[0100] 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, returning the needle support 16 upward and thus retracting the injection needle 15 inside the casing 9. The patient can then safely remove the medication delivery device without risk of anyone being pricked by the injection needle 15.

[0101] In a variant (not shown), activation of the reservoir fluid connection system may be performed by a different mechanism, such as a manually actuated button on the housing, that pushes the blocking finger 26 out of engagement with the septum needle support 19. In such a configuration, a sensor may be provided to prevent activation of the subcutaneous delivery system 13 and pump system 8 until the reservoir fluid connection system 17 is activated.

[0102] In embodiments including a pneumatic drive, the casing 9 includes a container casing 38 having a container-receiving cavity 75 therein, which surrounds the drug container 6 and is sealingly connected to a portion of the pump and needle system casing 37 surrounding 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 isolated from the volume within the pump and needle system casing 37 surrounding the pump engine 8, within which an inlet 30 on the stator 29 of the pump engine 28 is positioned to draw air into the pump engine. Accordingly, the casing 9 may include a valved or filtered inlet (not shown) for drawing air into the volume surrounding the pump engine.

[0103] Advantageously, in the pneumatic drive configuration of the present embodiment, the pump system 8 is operated to generate gas pressure inside the container casing 38, which in turn applies pressure to the rear end 73 of the plunger 12. This configuration allows for a very compact delivery unit, and therefore the drug delivery device 1, since there is no mechanical drive directly pushing the plunger, and therefore little space is required behind the plunger. Furthermore, the use of the pump engine 28, while known per se for pumping liquids, is particularly advantageous in pneumatic drive applications in terms of its very compact size and 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 perform as a substantially closed unit by gamma irradiation prior to assembly with the drug container 6.

[0104] 15a-15d, a medication delivery device with a pneumatic flow system and pneumatic drive may include a pressure sensor 80 to measure the pressure within the pneumatic flow system 71. As shown in FIG. 15b, the pressure within the pneumatic flow system measured over time indicates the displacement of the plunger 12. Blockage of the plunger due to an occlusion within the liquid flow system may be detected by an increase in the rate of pressure increase over time. The end of plunger travel, or in other words, emptying of the medication container, may also be readily detected by the increase in the rate of pressure increase, for example, as identified in section E of FIG. 15b.

[0105] As shown in Figure 15b, when a pneumatic pump system such as that described above is used, the air pumping action is preferably delivered in a pulsed manner, whereby a pump phase is followed by an inactive phase during which the pump is stopped, such that there is a fluctuation in air pressure that gives the sawtooth characteristics shown in Figures 15b and 15d. Each active pump phase can be achieved by a single rotation cycle (360° rotation) of the pump engine rotor 32, or by a predefined number of rotation cycles. The inactive phase during which the pump is stopped can be of a predefined duration depending on the desired drug delivery rate.

[0106] Pressure sensors are very economical and easy to integrate. Thus, an 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 the end position of the plunger within the container needs to be determined, such as shown in FIG. 15c. In such situations, precise confirmation of the plunger position is not required.

[0107] Plunger position can also be determined by other sensing means, and in another embodiment, plunger sensing system 70 includes an optical sensor 71 mounted on the rear end of the container facing end 73 of plunger 12. Container casing portion 38 of casing 9 includes a sensor window 43 or sensor prism 43' mounted in end portion 42 of container casing 38 facing plunger 12.

[0108] The optical sensor 71 may be positioned on the outer surface of the sensor window 43 or 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 time-of-flight (TOF) measurements. Advantageously, such time-of-flight optical sensors are particularly economical and easy to implement. To obtain practical measurements, the window 43 may be positioned on the raised plunger end portion 42 such that it has a certain minimum distance of 3 mm to 30 mm, e.g., 5 mm to 20 mm, at the initial position of the plunger 12 when the container is filled, so that the initial plunger position can be more easily detected by optical time-of-flight measurements.

[0109] The optical sensor 71 may be mounted on a circuit board 72 that projects laterally from the drive unit 4, as shown schematically in Figures 11a, 11b and 12a, 12b. In the variant shown in Figures 12a, 12b, the optical sensor may be positioned so that light is directed orthogonally to the direction of plunger movement, 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 of the initial position of the plunger when the container is filled can be made.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 16a-16e, another embodiment of the medication delivery device 1 is shown, in which the housing 2 is arranged differently. In this embodiment, instead of providing a reservoir casing 38 extending the entire length of the reservoir 6, a cap 44 is provided that forms the plunger end portion 42 of the reservoir casing and is configured to close a reservoir-receiving cavity 75 within the housing 2. A sealing ring 41 can be provided between the cap end cavity walls to hermetically close the reservoir 6 within the housing 2. An optical sensor 71 of the plunger sensing system 70 can be integrated within the cap 44 or positioned on a transparent sensor window 43. The optical sensor 71 can be mounted on a circuit board 72 that is electrically interconnected with contacts 45 protruding from the exterior of the cap for electrical connection with complementary contacts 45 on the housing 2. Thus, in this embodiment, the reservoir 6 can be mounted within the housing after assembly of the drive unit 4 and the delivery unit 3, allowing for insertion of the reservoir 6 by a patient or healthcare professional, as opposed to, for example, factory installation.

[0114] 17a and 17b, yet another embodiment of a medication delivery device is disclosed, which, like the embodiment of FIGS. 16a-16d, also allows a healthcare professional or user to insert a medication container 6 after the housing, drive unit, and delivery unit are assembled at a 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 that is inserted into and hermetically seals the rear open end of the container casing portion 38 when the container is inserted into the container casing portion. Note that portions of the drive unit are not shown in FIGS. 17a and 17b to enhance clarity of the illustration of the remaining portions.

[0115] 18a-18f, a medication delivery device according to an embodiment of the present invention advantageously includes 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 capacitance measurements that detect the presence of body tissue in proximity to a capacitive sensor. While capacitance sensors for measuring the proximity of a medical device on the sensor's skin are known per se, conventional sensors are not particularly reliable or costly to incorporate into medication delivery devices. In the present invention, the on-body sensing system 5 includes an electrode 56 that includes a metal layer formed directly on the inner surface of the housing's contact wall 81, and an outer surface of the housing's skin-contact wall 81 that is configured to be applied to the patient's skin.

[0116] The electrodes 56 can include or consist of a metal plate or PCB positioned on the inner side of the body-mounted wall 81 of the housing cover 2b. They can also be advantageously formed by vapor deposition of a metal layer on the inner surface of the housing cover 56, for example, by a plating process. The plating process can be a galvanic plating process, but other metal deposition techniques for directly forming a metallized layer on the inner surface of the skin-contacting wall 81 can also be used within the scope of the present invention. A method known per se for enabling galvanic plating on plastic parts is laser direct structuring (LDS) followed by a galvanic metallization process. To avoid the need for special LDS plastics, the electrodes can also be produced by in-mold labeling, screen printing in thick-film technology, inkjet printing in thin-film technology, or aerosol jet printing (AJP). The housing can be made of a thermoplastic or thermosetting polymer and is therefore an insulating material. The electrodes 56 can be connected to the electronic control system 47 of the drive unit 4 via interconnection terminals 61.

[0117] A method known per se to enable galvanic plating on plastic parts is laser direct structuring (LDS). To avoid the need for special LDS plastics, the electrodes can also be produced by in-mold labeling, screen printing in thick film technology, inkjet printing in thin film technology, or aerosol jet printing (AJP).

[0118] 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 spring beams configured to bear against the metal layer of the electrodes 56 when the drive unit 4 is assembled within the housing 2.

[0119] 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 the patient's skin.

[0120] 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 positioning of the drug delivery device on the patient's skin.

[0121] In a first embodiment, the 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.

[0122] In a second embodiment, the sensor electrodes can 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 that affect the capacitance measurement, such as moisture (sweat) at the contact interface, which may be rejected by the measurement system.

[0123] 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 varying capacitance values, taking into account the large capacitive coupling with the patient's skin.

[0124] 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 interference from external fields. This shielding 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 affixed 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.

[0125] In an advantageous embodiment, shown in FIGS. 18e and 18f, the electrode 56 is in the form of an integrally formed sheet metal part that is stamped from sheet metal and assembled onto the inner side of the skin-contacting wall 81. The electrode includes an integrally formed contact arm 61 with a contact terminal 62 at its end for biasing against a complementary electrical contact pad on the circuit board 48 when assembled within the housing. The contact arm 61 may have a certain elasticity to ensure good contact between the terminal end 62 and the circuit board. Alternatively, the contact terminal 62, which is integrally formed with and upstanding from the electrode base on the skin-contacting wall, may have a pin terminal end for insertion into a plated-through hole on the circuit board, or may have a contact terminal end configured for soldering or welding to the circuit board. The above-described embodiment is cost-effective and also provides a robust electrode with a large surface area for sensitive measurements.

[0126] 19a-19d, an advantageous method of assembling a medication delivery device according to an embodiment of the present invention will be described. First, referring to FIG. 19a, the manufacture of medication delivery device components that must be reliably sterilized is disclosed. As shown, a single component for a fluid pack is manufactured and assembled, which corresponds to the liquid flow system 7 and pump system 8 within the casing 9 of the previously described embodiment. The container cap shown in FIG. 19a corresponds to the container casing 38, which is assembled to the other casing components once the medication container 6 is inserted therein. The components of the medication container are manufactured separately, and the medication container is assembled to the fluid pack within the container cap under aseptic conditions (in this example, according to ISO Standard 5). Both the container cap and the fluid pack—i.e., the liquid flow system 7, pump system 8, and casing 9—can be sterilized with gamma radiation, which is highly reliable in destroying all pathogens. Other sterilization methods, including chemical and thermal sterilization methods including NO2 (nitrogen dioxide), VHP (vaporized hydrogen peroxide), ETO (ethylene oxide), and steam sterilization, can also be employed within the scope of the present invention. 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.

[0127] As noted in connection with the previously described embodiment, all outlets of the delivery unit 3 are provided with seals, particularly 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 so that the seal ruptures or breaks, for example, when the drive unit is assembled to the delivery unit and activated 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.

[0128] 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 Figure 19a.

[0129] Alternatively, as depicted in Figure 19b, the fluid cap and container cap may be manufactured at a first manufacturing facility, sterilized, preferably using gamma sterilization similar to the method according to Figure 19a, and then supplied to a second facility, e.g., within a pharmaceutical manufacturing company, where the drug containers are manufactured and filled. As noted above, other sterilization methods, including chemical and thermal sterilization methods (e.g., NO2, VHP, ETO, and steam sterilization), 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 within the second manufacturing site that produces the container packs.

[0130] As shown in Figures 19c and 19d, the sterile container pack representing the delivery unit 3 in an embodiment of the present specification can 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.

[0131] As shown in Figure 19d, various configurations of manufacturing and assembly at different locations can be implemented. For example, the drug container components can be supplied to a drug manufacturer that performs the filling process, and the fluid pack and container cap can be supplied to a pharmaceutical company at a second location for assembly of the container to the fluid pack and container cap to form a cartridge pack (i.e., corresponding to delivery unit 3 in embodiments described herein). The cartridge pack can then be assembled to the electronic components (i.e., corresponding to drive unit 4 in embodiments described herein), and other components can be assembled to the cartridge pack to form the drug delivery device, also at the pharmaceutical company's premises.

[0132] Advantageously, the delivery unit arrangement, including the casing 9 housing the liquid flow system 7 and pump system 8, can be sterilized by gamma sterilization 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.

[0133] [List of features] Drug 78 Drug delivery device 1 Housing 2 base 2a Cover 2b Skin (on the body) contact wall 81 Needle Orifice 10 adhesive layer Protective film 11 lid 2c Container Sealing Ring 77 Hinge coupler 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 Container 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 unit connection interface 33 Actuation disc 34 Recess 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 Interconnection terminal 61 Circuit board connection end 62 Electrode connection end 63 Spring beam

[0134] [Embodiment] (1) A drug delivery device (1), a housing (2); a delivery unit (3) including a drug container (6); a control unit (4) mounted inside the housing (2); Including, the control unit includes an on-body sensing system (5) including electrodes (56) connected to an electronic control system (47) of the control unit for measuring capacitance values ​​configured to detect whether the medication delivery device is positioned against the patient's skin, the on-body sensing system (5) including electrodes (56) connected to an electronic control system (47) of the control unit for measuring capacitance values ​​configured to detect whether the medication delivery device is positioned against the patient's skin, the skin-contacting wall (81) of the housing (2) having 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 patient's skin, A drug delivery device, characterized in that the electrode (56) comprises a layer of metal mounted directly against the inner side of the skin-contacting wall. (2) The drug delivery device of embodiment 1, wherein the metal layer of the electrode is a metal layer deposited directly onto the inner surface of the skin-contacting wall. (3) The drug delivery device of embodiment 2, wherein the directly deposited metal layer is a galvanic plating layer. (4) The drug delivery device of embodiment 1, wherein the on-body sensing system further comprises a shield (57) in the form of a conductor surrounding the electrode (56). (5) The drug delivery device of embodiment 1, wherein the on-body sensing system (5) includes a second electrode electrically isolated from the electrode constituting the first electrode, and the potential between the first electrode and the second electrode is measured to determine a capacitance value.

[0135] (6) A drug delivery device as described in embodiment 5, wherein the second electrode is formed as a metal layer directly on the inner side surface of the mounting wall. (7) A drug delivery device as described in embodiment 6, wherein the second electrode is formed as a metal layer, similar to the first electrode. (8) A drug delivery device as described in embodiment 5, wherein the second electrode and the first electrode have interleaved portions. (9) A drug delivery device as described in embodiment 1, wherein the metal electrode layer is made of a sheet metal plate punched out of sheet metal, and the electrode is assembled on the inner side of the skin-contacting wall. (10) A drug delivery device as described in embodiment 9, wherein the electrodes are integrally formed with the sheet metal plate and include interconnection terminals (61) rising therefrom to circuit board connection ends (62).

[0136] (11) A drug delivery device as described in embodiment 1, wherein the on-body sensing system (5) is configured to measure a capacitance value between the electrode and a ground value. (12) The delivery unit further includes a liquid flow system (7), a pump system (8), and a casing (9) enclosing the drug container, the pump system, and at least a portion of the liquid flow system; 2. The drug delivery device of claim 1, wherein the control unit includes a power source (50) and a pump driver (52) coupled to the pump system. (13) The drug delivery device of embodiment 12, wherein the pump drive (52) includes a rotary electric motor (53) and a connection interface (54) connected to the output shaft of the rotary electric motor, the connection interface (54) connects to a drive connection interface (33) of the pump system of the delivery unit, and the pump drive (52) provides torque to the rotor (32) of the pump system. (14) The medication delivery device of claim 12, comprising an injection delivery system including an injection needle and an injection needle actuation mechanism configured to move the injection needle from a retracted position within the housing (2) of the medication delivery device to an extended delivery position in which the injection needle protrudes through the skin-contacting wall of the housing. (15) The drug delivery device of embodiment 14, wherein the needle actuation mechanism includes a rotary actuation wheel (34) and an actuation lever (64), the actuation lever being coupled to a slidable needle support (16) on which the needle (15) is mounted, and the actuation wheel (34) being directly coupled to or integrally formed with a rotor (32) of a pump engine (28) of the pump system (8).

[0137] (16) The drug delivery device of embodiment 1, wherein the skin-contacting wall comprises an adhesive layer and a protective film covering the adhesive layer before use. (17) The drug delivery device of embodiment 16, wherein the adhesive layer contains silver ions or silver nanoparticles (AgNPs) as an antibacterial agent.

Claims

1. A drug delivery device (1), comprising: a housing (2); a delivery unit (3) containing a drug container (6); a control unit (4) mounted inside the housing (2); Including, the control unit includes an on-body sensing system (5) including electrodes (56) connected to an electronic control system (47) of the control unit for measuring capacitance values ​​configured to detect whether the medication delivery device is positioned against the patient's skin, the on-body sensing system (5) including electrodes (56) connected to an electronic control system (47) of the control unit for measuring capacitance values ​​configured to detect whether the medication 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 control 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 electrode (56) comprises a layer of metal mounted directly against the inner side of the skin-contacting wall; the on-body sensing system (5) includes a second electrode electrically isolated from the first electrode, and the potential between the first electrode and the second electrode is measured to determine a capacitance value; A drug delivery device, wherein the second electrode and the first electrode have interleaved portions.

2. The drug delivery device of claim 1 , wherein the metal layer of the first electrode comprises a metal layer deposited directly on the inner side of the skin-contacting wall.

3. The drug delivery device of claim 2 , wherein the directly deposited metal layer is a galvanic plating layer.

4. 2. The medication delivery device of claim 1, wherein the on-body sensing system further comprises a shield (57) in the form of a conductor surrounding the first and second electrodes (56a, 56b).

5. The drug delivery device of claim 1 , wherein the second electrode is formed as a metal layer directly on the inner side of the skin-contacting wall.

6. The drug delivery device of claim 5 , wherein the second electrode comprises a metal layer deposited directly on the inner side of the skin-contacting wall, the directly deposited metal layer being a galvanic plating layer.

7. 2. The medication delivery device of claim 1, wherein the on-body sensing system (5) is configured to measure a capacitance value between the first electrode and ground.

8. the delivery unit further comprises a liquid flow system (7), a pump system (8), and a casing (9) enclosing the drug container, the pump system, and at least a portion of the liquid flow system; 2. The medication delivery device of claim 1, wherein the control unit includes a power source (50) and a pump driver (52) coupled to the pump system.

9. 9. The drug delivery device of claim 8, wherein the pump drive (52) includes a rotary electric motor (53) and a connection interface (54) connected to an output shaft of the rotary electric motor, the connection interface (54) connecting to a drive connection interface (33) of the pump system of the delivery unit, and the pump drive (52) providing torque to a rotor (32) of the pump system.

10. 9. The medication delivery device of claim 8, comprising an injection delivery system including an injection needle and a needle actuation mechanism configured to move the injection needle from a retracted position within a housing (2) of the medication delivery device to an extended delivery position in which the injection needle protrudes through the skin-contacting wall of the housing.

11. 11. The medication delivery device of claim 10, wherein the needle actuation mechanism comprises a rotary actuation wheel (34) and an actuation lever (64), the actuation lever being coupled to a slidable needle support (16) on which the needle (15) is mounted, the actuation wheel (34) being directly coupled to or integrally formed with a rotor (32) of a pump engine (28) of the pump system (8).

12. 10. The medication delivery device of claim 1, wherein the skin-contacting wall comprises an adhesive layer and a protective film covering the adhesive layer prior to use.

13. The drug delivery device of claim 12 , wherein the adhesive layer contains silver ions or silver nanoparticles (AgNPs) as an antibacterial agent.

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