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WO2024126064A1 - Dispositif d'administration de médicament - Google Patents

Dispositif d'administration de médicament Download PDF

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Publication number
WO2024126064A1
WO2024126064A1 PCT/EP2023/083698 EP2023083698W WO2024126064A1 WO 2024126064 A1 WO2024126064 A1 WO 2024126064A1 EP 2023083698 W EP2023083698 W EP 2023083698W WO 2024126064 A1 WO2024126064 A1 WO 2024126064A1
Authority
WO
WIPO (PCT)
Prior art keywords
reservoir
fuel cell
delivery device
cap
medicament delivery
Prior art date
Application number
PCT/EP2023/083698
Other languages
English (en)
Inventor
Daniel SÄLL
Rasmus RENSTAD
Marcus Söderlund
Original Assignee
Shl Medical Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shl Medical Ag filed Critical Shl Medical Ag
Publication of WO2024126064A1 publication Critical patent/WO2024126064A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8268—Fuel storage cells

Definitions

  • the invention refers to a medicament delivery device.
  • Medicament delivery devices in short delivery devices, include pen type manual injectors and auto-injectors. These delivery devices are generally known for the selfadministration of a medicament by patients without formal medical training. For example, patients suffering from diabetes may require repeated injections of insulin, or patients may require regular injections of other types of medicaments, such as a growth hormone.
  • delivery devices are disposable devices to be disposed after one-time usage. Such devices and their usage cannot contribute to research or clinical studies in view of their disposable nature and the associate lack of connectivity functions to doctors, hospitals, etc.
  • distal direction refers to the direction pointing away from the dose delivery site during use of the medicament delivery device.
  • distal part/end refers to the part/end of the delivery device, or the parts/ ends of the members thereof, which during use of the medicament delivery device is/are located furthest away from the dose delivery site.
  • proximal direction refers to the direction pointing towards the dose delivery site during use of the medicament delivery device.
  • proximal part/ end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located closest to the dose delivery site.
  • longitudinal refers to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/ or component.
  • transverse refers to a direction generally perpendicular to the longitudinal direction.
  • circumference refers to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component.
  • radial refers to a direction extending radially relative to the axis
  • rotation refers to rotation relative to the axis.
  • a medicament delivery device comprising a fuel cell configured to generate electricity in response to a chemical reaction between a supplied fuel and an oxidizing agent, a reservoir filled by the fuel and arranged to supply the fuel to the fuel cell in response to an application of the medicament delivery device, a wireless communication interface, and an electric circuitry configured to transmit application data via the wireless communication interface in response to being powered by the fuel cell.
  • the delivery device preferably is embodied as one of a syringe, a manual injector and an auto-injector.
  • the delivery device is a disposable device intended for a one-time usage.
  • Providing a fuel cell in or at the delivery device has advantages over a battery driven electric circuitry for environmental reasons. Batteries may be difficult to recycle as the disposed devices are considered as hazardous waste. Accordingly, the usage of a fuel cell is an environmentally friendly alternative to batteries which does not create any hazardous substances after use.
  • the present delivery device ensures a high reliability of recorded timestamps from disposable devices.
  • the application data preferably are recorded at a destination such as a backend server, in combination with a timestamp indicating the effective application of the delivery device by the user.
  • the transmission of the relevant application data preferably is initiated without the user having to perform any additional step. Instead, the fuel cell is activated as soon as the patient performs an action to apply the delivery device, wherein applying the delivery device may include one of preparing the delivery device, injecting the drug, or accomplishing the injection.
  • the fuel cell can be any kind of a fuel cell that is sufficiently small to be integrated into delivery devices.
  • the fuel may be a fluid, preferably a liquid, and may comprise any of glycose, methanol or starch.
  • the oxidizing agent preferably is oxygen and may, in combination with an enzyme convert the fuel into electrical power.
  • the fuel cell is an enzymatic paper-based fuel cell that creates energy using glycose and oxygen as biofuel.
  • WO2O21/ 170826A1, W02021/094593A1, and WO2O19/234573A1 the content of all of which documents are incorporated by reference.
  • a storage for the preferably liquid fuel, the storage being referred to as reservoir in the following.
  • the reservoir preferably comprises a sealed compartment, and a sealed channel connecting the compartment to an inlet of the fuel cell.
  • the reservoir is a blister, in which the liquid fuel is stored in a blister bubble.
  • the blister is formed by two layers, e.g. laminated foils, storing the fuel in between. At least one of the two layers is a flexible layer bulging out in response to filling the reservoir with the fuel.
  • the layers In response to a compression, of the reservoir, the layers (which may be attached to each other only in their circumferences), separate which enables the liquid to be transported by capillary forces via an inlet into the active layers of the fuel cell.
  • the channel In case of a sealed channel being arranged between the reservoir and the fuel cell, the channel is opened in response to the compression acting on the reservoir.
  • pressure acting on the reservoir may trigger e.g. a needle structure to penetrate a layer and / or open a channel for the fuel to enter the fuel cell.
  • the fuel cell may then by capillary forces be able to suck fuel with capillary force from the reservoir.
  • Other mechanisms may be applied to trigger an inlet of the fuel cell to be opened or created in response to a compression of the reservoir. Accordingly, when the reservoir is compressed, the liquid is transported, preferably by way of capillary forces, into the active layers of the fuel cell. This triggers the reaction to generate electricity in the fuel cell.
  • the delivery device comprises the electrical circuitry which may include one or more of an energy storage for storing the electrical energy generated by the fuel cell, such as a capacitor, a processor or hardwired logic to perform control functions, preferably configured to control at least the wireless communication interface, a memory for storing data, such as the application data.
  • the wireless communication interface is configured to transmit the application data to a backend.
  • the wireless communication interface preferably is a wireless radio interface, preferably is one of a Bluetooth interface, an NFC interface, etc.
  • the recipient of the application data at the backend preferably is a computing entity with a corresponding interface for receiving the application data.
  • the computing entity such as a server may reside at a doctor’s, a hospital, a university.
  • the application data preferably includes an identifier of the delivery device.
  • each device Upon delivery of the devices from a manufacturer, each device preferably is assigned a unique identifier for identifying the device through its way of life.
  • the identifiers are registered with the manufacturer and/or a filling station.
  • the identifier is electronically stored in a memory of the electronic circuitry.
  • the identifier may be printed on the delivery device, e.g. on its enclosure.
  • the application data may additionally include one or more of data from sensors installed in the delivery device, e.g. from a temperature and/or a humidity sensor. Such data can serve for monitoring environmental conditions of the delivery device during application.
  • the received application data are time stamped, and are stored in a storage, preferably in which storage the identifier of the delivery device is mapped to a user of the delivery device.
  • Such mapping preferably is performed by the doctor, pharmacy or other entity supplying the delivery device to the user.
  • a system comprising a delivery device according to any of the preceding and subsequent embodiments, and a computing entity comprising a corresponding wireless communication interface, and a storage for storing the received application data, and preferably an engine for assigning the received application data to user data of a user of the delivery device.
  • the reservoir and the fuel cell are arranged on a common fuel cell carrier, as well as the wireless communication interface and the electrical circuitry.
  • a common fuel cell carrier including the various components may also be referred to as smart label, in particular in case it is of thin, flexible shape and as such easily attachable to the desired component of the delivery device, preferably by gluing.
  • the reservoir is arranged on top of the fuel cell which fuel cell is arranged on the fuel cell carrier.
  • the fuel cell and the reservoir are both arranged, e.g. next to each other, on the fuel cell carrier.
  • the fuel cell and/or the reservoir maybe integrated into a layered structure of the fuel cell carrier, wherein the fuel cell carrier, the reservoir and the fuel cell carrier may in combination be formed by a layered set-up.
  • the fuel cell carrier may be a component distinct from the fuel cell and the reservoir, such as a printed circuit board (PCB), preferably a flexible PCB. This facilitates attaching the fuel cell carrier to a component of the delivery device.
  • PCB printed circuit board
  • the fuel cell carrier is a rigid carrier, such as a cap.
  • the fuel cell and the reservoir preferably are stacked inside the cap.
  • the electrical circuitry, and also the wireless communication interface may be embodied in one or more distinct components separate from the fuel cell.
  • the electrical circuitry and/or the wireless communication interface may be integrated into the fuel cell, e.g. by integration into a layered structure of the fuel cell.
  • a mechanical component is provided that is axially or rotationally movable relative to the reservoir. Accordingly, the component is axially or radially moved or dislocated with respect to the reservoir in response to the application of the medicament delivery device.
  • the component in a pre-application state of the delivery device, the component preferably is decoupled from the reservoir, i.e. not applying pressure on the reservoir.
  • the component In response to the application, the component is actuated to get in touch with and exert a pressure onto the reservoir. This pressure effects a compression of the reservoir and subsequently a supply of the fuel from the reservoir into the fuel cell.
  • Such component preferably is a mechanical component that anyway contributes to the delivery device, and that becomes actuated at the beginning or during or at the end of the drug delivery.
  • the application of the medicament delivery device includes one or more of a preparation of the medicament delivery device for a delivery of the medicament out of the container, a delivery of the medicament out of the container, and an accomplished delivery of the medicament out of the container.
  • the component acting on the reservoir preferably is one of a push button, a cap, a sleeve, a lock bracket, a plunger rod.
  • the delivery device extends along a longitudinal axis between a proximal end and a distal end, and comprises a container configured to store the medicament and an enclosure for the container.
  • the enclosure preferably is of tubular shape including an opening at its proximal and its distal end.
  • a rear cap covers the distal end opening of the container, and a cap covers the proximal end opening of the container.
  • This cap preferably is a releasable cap and needs to be removed from the delivery device prior to usage.
  • the cap is the component to act on the reservoir upon application of the delivery device.
  • the cap preferably comprises a transversal cover and a circumferential cap shell extending from the cover in distal direction.
  • the cover is configured to cover the proximal opening of the enclosure and/or a proximal opening of a needle cover sleeve arranged slidable inside the enclosure.
  • the cap shell extends in axial direction and may enclose the needle cover sleeve in its extended position relative to the enclosure, and/or may comprise mounting means to releasable mount the cap to the enclosure and/or the needle cover sleeve.
  • the reservoir preferably is attached to one of a radial outer surface of the enclosure and a radial inner surface of the cap shell.
  • the cap is the component to be actuated for applying the delivery device, i.e. presently for preparing the delivery device into a state ready to use
  • a movement of the cap, and preferably a removal of the cap from the delivery device effects pressure on the reservoir and initiates the fuel supply to the fuel cell.
  • the movement or dislocation of the cap relative to the enclosure preferably is performed manually, e.g. by a user stripping the cap from the delivery device, e.g. in an axial movement, or in a rotational movement relative to the enclosure.
  • actuation effects the supply of the fuel out of the reservoir.
  • the cap comprises an opening in the cap shell.
  • a bulge of the reservoir reaches into the opening of the cap shell in a pre-application state of the medicament delivery device.
  • a rim of the opening in the cap shell presses against the bulge with the fuel and increases the pressure in the reservoir which effects an opening of the channel and/or the inlet, and a pouring of the fuel into the fuel cell, the pouring being e.g. supported by capillary forces.
  • a sleeve is provided in addition to the cap.
  • the sleeve preferably is a circumferential component and surrounds at least a portion of one or more of the enclosure and the cap shell.
  • the sleeve can also be regarded as floating cap.
  • the reservoir is attached to one of a radial outer surface of the enclosure, a radial outer surface of the cap shell, and a radial inner surface of the sleeve.
  • the component effecting the pressure on the reservoir now is the sleeve, such that one or more of an axial and a rotational actuation of the sleeve relative to the enclosure or relative to the cap represents the application of the medicament delivery device and effects the supply of the fuel out of the reservoir.
  • the sleeve preferably comprises an opening in its circumference.
  • a bulge of the reservoir reaches into the opening of the sleeve in a pre-application state of the medicament delivery device.
  • a rim of the opening in the sleeve presses against the bulge and increases the pressure in the reservoir.
  • the sleeve comprises a cam to engage with the cap shell.
  • the cam is preferably arranged relative to the cap shell such that, in response to the sleeve reaching a defined axial or rotational position relative to the cap shell, the cam engages with the cap shell and effects the translational or rotational movement of the combination of the two, relative to the enclosure.
  • the cam may also be arranged at the cap shell, or, more generally at the cap.
  • the application of the sleeve is beneficial in that a force required to pull off the regular cap is sometimes very high.
  • the compression of the reservoir and the subsequent activation of the fuel call can be triggered by applying a lower force which allows for a better controlled compression of the reservoir.
  • a maximum force for finally removing the cap is not increased by adding the fuel activation function to the cap.
  • a lock bracket of the delivery device is the component responsible for pressing onto the reservoir and thus actuating the generation of electricity.
  • Such lock bracket is preferably arranged in and axially slidable or rotatable relative to the enclosure.
  • the delivery device additionally comprises a plunger rod configured to act on a stopper of the container of the delivery device containing the medicament.
  • a plunger rod spring arranged between the plunger rod and the lock bracket drives the plunger rod relative to the container and the lock bracket relative to the rear cap.
  • the reservoir is arranged, in axial direction, between the lock bracket and the rear cap.
  • a fuel cell carrier supports the reservoir and the fuel cell. Accordingly, it is preferred that the fuel cell carrier, the fuel cell and the reservoir are arranged, in axial direction, between the lock bracket and the rear cap. Preferably, the fuel cell is arranged on top the fuel cell carrier, and the reservoir is arranged on top of the fuel cell in distal direction, such that the reservoir faces the rear cap.
  • the fuel cell carrier may comprise a transversal platform with an engaging surface facing a distal end of the lock bracket.
  • the fuel cell carrier In a pre-application state, the fuel cell carrier is preferably arranged distant from the lock bracket.
  • the fuel cell carrier may be supported by the enclosure, the rear cap or other component in this position.
  • the reservoir In this pre-application state, the reservoir may already be in touch with the rear cap, absent any pressure acting on the reservoir.
  • the lock bracket overcomes the distance to the reservoir and/or fuel cell carrier, and hits on the reservoir and/or fuel cell carrier.
  • This engagement preferably results in an audible sound indicating the application of the delivery device to the user.
  • the application represents a state of accomplished drug delivery.
  • the audible sound may be promoted by mechanical means such as an end click structure mounted to the fuel cell carrier or the lock bracket.
  • the audible sound is generated by providing a rigid fuel cell platform. Instead, in case the lock bracket directly hits the reservoir such action may rather be silent as the impact may be dampened by the blister bubble.
  • the present embodiment also facilitates the generation of an audible sound with a delay functionality. This may sometimes be desired for the patient to hold the device in place for seconds after the drug has been injected to allow for a pressure equalization and/or a backflow/leakage of drug. An electrical signal may indicate for the patient when to lift the device.
  • one or more of a visual and tactile indicator maybe provided indicating an extended state of the plunger rod and/or a retracted, i.e. locked state of the lock bracket.
  • the lock bracket preferably prevents the plunger rod and/or needle cover sleeve to be retracted again from their proximal position into a distal position, relative to the enclosure.
  • the planar fuel cell carrier driven by the plunger rod spring, effects a constant pressure on the pressure that may cause an internal leakage.
  • the fuel cell carrier comprises a protrusion in distal direction.
  • the protrusion is meant to rupture the layers defining the reservoir in response to the impact of the lock bracket on the fuel cell carrier. This rupture initiates emptying the reservoir. After such rupture, the protrusion prevents that a constant pressure acts on the reservoir, given that the protrusion blocks the fuel cell carrier from further travelling into the distal direction and exerting a constant pressure on the reservoir.
  • the present feature of the fuel cell induced wireless application data transmission in response to an application or actuation of the delivery device may be attractive to some delivery devices and/or markets but not to others. It maybe desired to provide a solution absent the data transmission feature, however, including an audible sound feature effected at the same time if the fuel cell carrier arrangement were present.
  • the lock bracket hits the fuel cell carrier at a defined longitudinal position. Absent the fuel cell module, the audible click preferably is achieved at the same position, in case a stopper is arranged at the rear cap facing the lock bracket and having an axial length that corresponds to the axial length of the fuel cell module including the fuel cell carrier, the fuel cell and the reservoir. Therefore, according to another aspect of the present invention, a kit of parts is provided including a delivery device according claim 12 including the protrusion at the fuel cell carrier, and the kit of parts including a rear cap with a stopper extending in proximal direction.
  • the medicament delivery device is a syringe or a manual auto-injector.
  • a manual actuator is provided, typically arranged at the distal end of the device.
  • the reservoir now is arranged on or at the manual actuator, preferably on top of the distal end of the manual actuator.
  • the user presses on the reservoir and/or on the fuel cell carrier which is attached to the usual push button.
  • the fuel cell carrier supports both the fuel cell and the reservoir.
  • the fuel cell carrier is cap-shaped and has a closed distal front and an open proximal end
  • the reservoir is preferably exposed at the proximal end
  • the fuel cell carrier is attached to the manual actuator with the reservoir facing a distal surface of the manual actuator.
  • the attachment is a non-releasable attachment such as by one or more of gluing, a snap fit, a press fit, or other suitable mounting means.
  • the fuel cell carrier and the push button show little tolerance in longitudinal direction which enables the reservoir to be compressed in response to pushing the push button. It is expected that while a user presses the distal end of the fuel cell carrier in proximal direction, the fuel cell carrier conveys the pushing force onto the push button which in turn triggers the release of the medicament. At the same time, it is expected that the reservoir is sufficiently compressed to release the fuel into the fuel cell.
  • the cylindrical fuel cell carrier may have an elastic front at its distal end which allows the fuel cell and the reservoir inside the fuel cell carrier to be pushed relative to and towards the push button, thereby effecting the reservoir being compressed and releasing the stored fuel.
  • side walls of the fuel cell carrier may be stiff and be used for attaching the fuel cell carrier to the push button.
  • the entire fuel cell carrier is preferably made from elastic material allowing the manual force applied to the distal front be conveyed to the reservoir and pressing the reservoir against the push button.
  • such medicament delivery device is a syringe, wherein the container holds the medicament, wherein a needle is arranged at the proximal end of the container, wherein a plunger rod is arranged at the distal end and reaches into the container, and wherein the plunger rod represents the manual actuator for expelling the medicament from the container.
  • the medicament delivery device is a manual injector, wherein a push button of the manual type injector represents the manual actuator.
  • the injector still comprises a push button, however, the reservoir and/or the fuel cell carrier no longer are arranged on or at the push button. Instead, they are arranged at or in the enclosure. Accordingly, the reservoir is arranged relative to the enclosure such that an axial or rotational actuation of the push button relative to the enclosure presses on the reservoir and, hence, represents the application of the medicament delivery device that effects the supply of the fuel out of the reservoir.
  • the push button may have, in one embodiment, an arm protruding in proximal direction for acting on the reservoir.
  • a method is provided for operating a medicament delivery device. In this method, the medicament delivery device is applied, preferably by a user. In response to this application, a fuel stored in the medicament delivery device is automatically supplied to a fuel cell of the medicament delivery device. This causes the fuel cell to generate electricity. In response to the fuel cell generating the electricity, application data is wireless transmitted.
  • the transmission of the application data in response to the fuel cell generating electricity is to be understood in a non-limiting manner: In one embodiment, the transmission is automatically initiated as soon as sufficient electricity is generated to power the wireless communication interface and the electric circuitry that may control the wireless communication interface and the process of transmitting data. However, the transmission of the application data in response to generating the electricity shall also encompass the powering of the wireless communication interface and the electric circuitry first, and only in response to additional criteria met actually transmit the application data.
  • Figure i illustrates a cut view of a reservoir and a fuel cell as used in a medicament delivery device according to an embodiment of the present invention
  • Figure 2 illustrates a schematic diagram of components as used in a medicament delivery device, according to an embodiment of the present invention
  • Figure 3 illustrates different views of a medicament delivery device, according to an embodiment of the present invention
  • Figure 4 illustrates different views of another medicament delivery, according to an embodiment of the present invention
  • Figure 5 illustrates different vies of a further medicament delivery device, according to an embodiment of the present invention
  • Figure 6 illustrates perspective views of components of a medicament delivery, according to an embodiment of the present invention
  • Figure 7 illustrates cut views of a sub-assembly of a medicament delivery device, according to an embodiment of the present invention
  • Figure 8 illustrates a cut view of the upper half of a distal portion of a medicament delivery device in different states, according to an embodiment of the present invention
  • Figure 9 illustrates a cut view of the upper half of a distal portion of a medicament delivery device, according to another embodiment of the present invention.
  • Figure 10 illustrates a cut view the upper half of a distal portion of a medicament delivery device
  • Figure 11 illustrates a perspective view of a fuel cell module, according to an embodiment of the present invention.
  • Figure 12 illustrates a side view of a medicament delivery device, according to an embodiment of the present invention
  • Figure 13 illustrates a side view of another medicament delivery device, according to an embodiment of the present invention.
  • Figure 14 illustrates a transparent side view of medicament delivery device, according to an embodiment of the present invention.
  • Figure 15 illustrates a flowchart representing a method for operating a medicament delivery device, according to an embodiment of the present invention.
  • Figure 1 illustrates a cut view of a reservoir 9 and a fuel cell 11 as used in a medicament delivery device according to an embodiment of the present invention.
  • the fuel cell 11 and the reservoir 9 are stacked on each other in vertical direction z.
  • the reservoir 9 preferably comprises two layers 91 and 92, wherein at least the second, upper layer 92 is a flexible layer.
  • the first, bottom layer 91 preferably is attached to a top layer of the fuel cell 11, and, in one embodiment may also contribute to the fuel cell 11 as a top layer.
  • the first and second layer 91 and 92 are attached to each other solely along their circumferences. This enables a filling of the space between the two layers 91, 92 with a fuel 93 intended to be supplied to the fuel cell 11 for generating electricity.
  • the reservoir 9 is assumed to be filled by a liquid fuel 93, which filling causes the second layer 92 to bulge in vertical -z-direction.
  • the first layer 91 preferably comprises a through hole serving as an inlet 10 to the fuel cell 11.
  • the inlet 10 is arranged radially in an area in which, absent a pressure acting on the reservoir 9, the first and second layer 91, 92 are attached to each other, as is shown in Figure 1, which represents a state of the reservoir 9 - fuel cell 11 - combination prior to an application of the corresponding delivery device.
  • the reservoir 9 and hence the fuel 93 inside the reservoir 9 becomes compressed and effects a partial detachment of the layers 91 and 92 from each other, the detachment radially propagating from inner positions to the outside. While in the state shown in Figure 1 the pressure is not sufficient enough to detach the layers 91 and 92 an increased pressure may initiate the detaching process such that the inlet 10 uncovers from the second layer 92 and the fuel 93 can pour through the inlet 10 into the fuel cell 11.
  • a permanent pressure acting on the reservoir 9 may lead to a complete emptying of the reservoir 9 from the fuel 93 thereby enabling the fuel cell 11 to generate electricity over some time.
  • the fuel cell 11 preferably comprises the following layers, stacked on each other, from top to bottom: A collector layer 111 for collecting the fuel 93 received via the inlet 10; an anode layer 112; a microfluidic layer 113; a cathode layer 114; a diffusion and collector layer 115; and a bottom layer 116. Additional layers or replacement layers may be provided as long as the fuel cell functionality is maintained.
  • FIG. 2 illustrates a schematic diagram of components as used in a medicament delivery device, according to an embodiment of the present invention.
  • a fuel cell carrier 12 is embodied as printed circuit board, preferably as a flexible printed circuit board.
  • Various electrical components are electrically connected to each other via the fuel cell carrier 12: 1.e. a component including the reservoir 9 and the fuel cell 11, such as illustrated in Figure 1; a wireless communication interface 18 for at least sending information to the outside world; electric circuitry 17 preferably including one or more of an energy storage for storing the electrical energy generated by the fuel cell n, a processor or hardwired logic to perform control functions, preferably configured to control at least the wireless communication interface 18, a memory for storing data, such as application data, preferably for storing at least an identifier of the present delivery device.
  • Figure 3 illustrates a perspective view of a medicament delivery device 100 in three different states, i.e. a) in a pre-application state, b) in an application state, c) in a cap removed state, according to an embodiment of the present invention.
  • the delivery device 100 preferably is an injector, preferably an auto-injector.
  • the delivery device 100 comprises a tubular shaped enclosure 8 enclosing a non- visible container for storing the medicament.
  • the delivery device 100 further comprises a cap 4 arranged at the proximal end P of the delivery device 100.
  • a fuel cell carrier 12 is attached to an outer surface of the enclosure 8 at the proximal end.
  • the fuel cell carrier 12 supports a fuel cell 11 and a reservoir 9-
  • the cap 4 serves for protecting a needle concealed in the enclosure 8 and covers proximal openings of the enclosure 8 and/or a needle cover sleeve (not visible) arranged in and slidable relative to the enclosure 8.
  • the cap 4 comprises a transversal cover 41 and a circumferential cap shell 42 for engaging with the enclosure 8 and/or the needle cover sleeve.
  • the cap shell 42 has an opening 43 in its circumference and is arranged at a longitudinal position such that the opening 43 can interact with the reservoir 9.
  • the reservoir 9 is illustrated in form of a blister with a bulge protruding radially from the enclosure 8 and fully reaches into the opening 43.
  • the reservoir 9 is connected to an inlet 10 of the fuel cell 11 by way of a channel 94 presently sealed.
  • the state of the delivery device 100 shown in Figure 3a) is an initial state, i.e. a preapplication state. In this state, the reservoir 9, and specifically its bulge, completely reaches into the opening 43 of the cap shell 42 absent any compression acting on the reservoir 9.
  • the inlet 10 of the fuel cell 11 is connected with the reservoir 9 by means of a sealed channel 94.
  • the sealed channel 94 may also be built from the layers forming the reservoir 9.
  • the cap 4 is slidable arranged and is to be removed prior to a drug delivery.
  • the removal of the cap 4 is effected by pulling the cap 4 in proximal direction from the enclosure 8.
  • the pulling of the cap 4 represents the application of the delivery device 100 in that the delivery device will be prepared for drug delivery.
  • Figure 3b) illustrates such state, in which the cap 4 is pulled from the delivery device 100 in proximal direction and relative to the enclosure 8, preferably by a user, for preparing an injection of the medicament.
  • a rim defining the opening 43 in the cap shell 42 compresses the bulge of the reservoir 9 reaching into the opening 51.
  • the previously sealed channel 94 opens and allows the fuel to enter the inlet 10.
  • Figure 4 illustrates a perspective view of a medicament delivery device 100 in five different states, i.e. a) in pre-assembled state, b) in a state while assembling a sleeve 5, c) in an assembled, pre-application state, d) in an application state, and e) in a cap removed state, according to an embodiment of the present invention.
  • the delivery device 100 which preferably is an injector, and more preferably is an auto-injector, maybe similar to the one illustrated in Fig. 3.
  • a fuel cell carrier 12 again is attached to the outer surface of the enclosure 8 at the proximal end. And again, the fuel cell carrier 12 supports a fuel cell 11, an inlet 10, a reservoir 9, and a sealed channel 94 between the reservoir 9 and the inlet 10.
  • the cap 4 in particular the cap shell 42 of the delivery device 100 of Figure 4 no longer comprises an opening. Instead, the cap shell 42 includes striae on its outer surface.
  • a sleeve 5 is assembled to the proximal end of the delivery device of Fig. 4a).
  • the sleeve 5 may have a hinge allowing the sleeve 5 to switch along a longitudinal axis between an open position as shown in Fig. 4b) and a closed position shown in Fig. 4c), which latter Figure illustrates the fully assembled, pre-application state of the delivery device 100.
  • the sleeve 5 is tubular shaped and acts as a cover for the proximal portion of the enclosure 8 and for the cap shell 42.
  • the sleeve 5 preferably has an opening 51 in its circumference and is arranged at a longitudinal position such that the opening 51 interacts with the reservoir 9 illustrated in form of a blister with a bulge protruding radially from the enclosure 8 in the assembled and pre-application state of Fig. 4c).
  • the sleeve 5 slides between the assembled, pre-application state as shown in Fig 4c) and an applied state as shown in Figure 4d). Accordingly, the sleeve 5 can manually be actuated by a user and shifted in proximal direction relative to the enclosure 8 and relative to the cap 4. In doing so a rim defining the opening 51 of the sleeve 5 compresses the bulge of the reservoir 9 reaching into the opening 51. This shift of the sleeve 5 in proximal direction causes, in view of the increased pressure in the fluid, the previously sealed channel 94 to open and allows the fuel to enter the inlet 10. This latter state is shown in Figure 4d).
  • the striae 44 on the outer surface of the cap shell 42 prevent the sleeve 5 from being pushed back in distal direction relative to the cap 4.
  • the striae 44 preferably interact with an inner surface of the sleeve 5 and contribute to a snap fit.
  • the sleeve 5 is moved in proximal direction relative to the enclosure 8 and relative to the cap 4. In the state of Fig. 4d), however, the drug delivery is not yet initiated. Nevertheless, the delivery device 100 is considered to be applied in that it is prepared for usage.
  • the slide of the sleeve 5 relative to the cap 4 is a pre-condition for removing the cap 4 together with the sleeve 5 from the rest of delivery device 100.
  • the user continues pushing the shell 5 in proximal direction.
  • the sleeve 5 comprises a cam 52 protruding radially inwards, see Fig.
  • the cam 52 acts as a stop in combination with a distal rim of the cap shell 42. Now, any further movement of the sleeve 5 in proximal direction relative to the cap 4 is prevented by the sleeve’s cam 52 engaging with the cap shell’s rim. In this state, it is assumed that a major portion of the fuel is expelled through the inlet 10 into the fuel cell 11. In view of the cam’s 52 engagement with the cap 4 and the increasing radius of the outer surface of the cap shell 42 in proximal direction, the sleeve 5 no longer can move relative to the cap 4. From here on, the sleeve 5 - cap 4 - combination is removed together from the delivery device 100.
  • a NIT cap 3 - visible in Fig. 4e) and provided for protecting the needle 2 - is also is removed in view of its coupling to the cap 4.
  • the delivery device 100 absent the sleeve 5 and the cap 4 is in a state ready for drug delivery.
  • a needle cover sleeve 6 previously concealed in the enclosure 8 now protrudes from the enclosure 8 at the proximal end and protects the needle 2 indicated by a dashed line.
  • Figure 5 illustrates a perspective view of a medicament delivery device 100 in five different states, i.e. a) in pre-assembled state, b) in a state while assembling a sleeve 5, c) in an assembled, pre-application state, d) in an application state, and e) in a cap removed state, according to an embodiment of the present invention.
  • the delivery device 100 which preferably is an injector, and more preferably is an auto-injector, may be similar to the one illustrated in Fig. 4.
  • the fuel cell carrier 12 now is attached to an outer surface of the cap shell 42, instead of to an outer surface of the enclosure 8.
  • the sleeve 5 now only surrounds the cap shell 42 in the assembled state shown in Fig. 5c).
  • the sleeve 5 is pushed relative to the cap 4 in proximal direction.
  • the sleeve 5 is pushed in combination with the cap 4 relative to the enclosure 8 in proximal direction, e.g. because of an engagement of the sleeve’s cam 52 with the cap 4.
  • the cam 52 now is provided at the distal end of the sleeve 5, see Fig. 5b).
  • Figure 6 illustrates perspective views of components of a medicament delivery, preferably of an auto-injector, according to an embodiment of the present invention.
  • the illustrated components represent a drive sub-assembly of the medicament delivery device and include a plunger rod 13, a plunger rod spring 14 and a lock bracket 15.
  • these components are shown in an assembled state, with a transparent view of the tubular plunger rod 13.
  • the lock bracket 15 is shown in a perspective view.
  • the lock bracket 15 - plunger rod spring 14 combination is shown in a view exploded from the plunger rod 13.
  • the plunger rod 13 is of tubular shape with a closed front at its proximal end P.
  • the plunger rod spring 14 is arranged in the plunger rod 13 and is biased between the closed front of the plunger rod 13 and the lock bracket 15. Accordingly, in case of the plunger rod spring 14 is biased the plunger rod 13 is driven into proximal direction wherein the plunger rod 13 preferably meets a stopper of a container holding the medicament.
  • the stopper typically is arranged slidable within the container, and the plunger rod 13 pushes the stopper further into the container for expelling the medicament from the container, e.g. through a needle.
  • the lock bracket 15 comprises a platform 151, legs 152 protruding from the platform 151 in proximal direction, and snap fits 153 arranged at the proximal end of the legs 152.
  • the legs 152 are radially resilient legs. It can be derived from the assembled state of Figure 6a) that the legs 152 of the lock bracket 15 reside outside and are biased radially outwards by the plunger rod 13. Accordingly, starting from the biased state of the plunger rod spring 14 such as shown in Figure 6a), the plunger rod spring 14 drives to separate the plunger rod 13 from the lock bracket 15. While doing so, at one point in time the proximal ends of the legs 152 of the lock bracket 15 move radially inwards due to lack of a counterforce previously exerted by the plunger rod 13. This situation is shown in Figure 6c).
  • FIG 7 illustrates cut views of a sub-assembly of a medicament delivery device, according to an embodiment of the present invention.
  • a housing such as a rear cap 16 is shown, which rear cap 16 at least partly supports the components.
  • the lock bracket 15 is arranged at a distance D from a cover 161 of the rear cap 16.
  • the legs of the lock bracket 15 are biased outwards by means of the plunger rod 13, and the snap fits 153 of the lock bracket 15 are engaged with a shell 162 or legs of the rear cap 16 extending in proximal direction.
  • any movement of the lock bracket 15 in distal direction is prevented by the locked snap fits 153.
  • the plunger rod 13 travels in proximal direction to finally hit and push the stopper of the drug containing container (not shown).
  • Figure 7b) illustrates a state in which the plunger rod spring 14 already caused the plunger rod 13 to extend from the lock bracket 15 substantially. In this state, it is assumed that the medicament is delivered out of the container.
  • Figure 7c) illustrates a state in which the plunger rod spring 14 caused the plunger rod 13 to extend from the lock bracket 15 even further compared to the state shown in Figure 6b). This state preferably represents a state of an accomplished delivery of the medicament.
  • the plunger rod 13 has disengaged from the lock bracket 15, and preferably from its legs 152. Accordingly, the legs 152 no longer have a counter bearing in the plunger rod 13. As a result, they relax, i.e. move radially inwards.
  • FIG 8 illustrates a cut view the upper half of a rear portion of a medicament delivery device 100 in different states, according to an embodiment of the present invention.
  • This delivery device 100 includes the components and their interaction as illustrated in Figures 6 and 7.
  • Figure 8a) illustrates an initial state representing the state shown in Figure 7a):
  • the lock bracket 15 is arranged at a distance from the rear cap 16, and a distance D from a module illustrated in more detail below.
  • the plunger rod 13 still is visible in this view indicating that the plunger rod spring 14 is arranged in a biased state between the plunger rod 13 and the lock bracket 15.
  • the plunger rod spring 14 is supported by a guide rod 7 e.g. being part of the lock bracket 15 or of the rear cap 16 or being a separate part.
  • the rear cap 16 and an enclosure 8 in combination form a housing of the delivery device 100.
  • the enclosure 8 preferably is of tubular shape and has multiple parts attached to each other.
  • the rear cap 16 comprises legs 162 engaged with the enclosure 8 in a snap fit.
  • a rotator 81 is provided in between parts of the enclosure 8, a rotator 81 is provided.
  • a module referred to as fuel cell module is arranged between the lock bracket 15 and the rear cap 16, more specifically between the platform 151 of the lock bracket 15 and the cover 161 of the rear cap 16.
  • the fuel cell module preferably comprises a fuel cell carrier 12, comprising a platform 121 and legs 122 or a shell protruding from the platform 121 in proximal direction.
  • the legs 122 are of a length that in the initial state shown in Figure 8a), the distal end of the lock bracket 15 yet is arranged within the legs 122.
  • the legs 122 act as a guide for a later transition of the lock bracket 15 in distal direction.
  • Figure 8b illustrates a state of the delivery device 100 that represents the state shown in Figure 7c), i.e. a state of accomplished drug delivery:
  • the plunger rod 13 no longer is visible and has further moved in proximal direction under the impact of the biased plunger rod spring 14.
  • the plunger rod spring 14 pushes the released lock bracket 15 in distal direction which finally hits a surface of the fuel cell carrier 12 facing the lock bracket 15. No longer is there a gap between the fuel cell module and the lock bracket 15.
  • the fuel cell carrier 12 supports a fuel cell 11 and a reservoir 9 including fuel which reservoir 9 comprises an inlet 10 connecting the reservoir 9 with the fuel cell 11.
  • the fuel cell 11, the reservoir 9 and the inlet 10 may e.g. be embodied as shown in Figure 1. Accordingly, the reservoir 9 is provided in from of a blister made by a flexible layer and another layer attached to the fuel cell 11. The flexible layer is bulged in distal direction in view of the filling of the reservoir 9 by the fuel.
  • the reservoir 9, i.e. the blister is arranged between the fuel cell 11 and the cover 161 of the rear cap 16.
  • the plunger rod spring 14 continuously pressing on the fuel call carrier 12 in distal direction, the reservoir 9 is compressed. The compression effects that the inlet 10 is reached by the fuel. This state is shown in Figure 8c): The reservoir 9 is compressed and the fuel pours through the inlet 10 into the fuel cell 11.
  • Figure 9 illustrates a cut view of a rear portion of a medicament delivery device 100, according to another embodiment of the present invention. In the following, only the differences are described with respect to the embodiment of Figure 8.
  • the state of the delivery device 100 shown in Figure 9 corresponds to the state shown in Figure 8c), i.e. during activation of the fuel cell 11.
  • the fuel cell carrier 12 of Figure 9 has a different shape: While the fuel cell carrier 12 still comprises a platform 121, a protrusion 123 extends from the platform 121 in distal direction, preferably from a centre of the platform 121. Hence, while the lock bracket 15 pushing the fuel cell module in distal direction in response to the force of the plunger rod spring 14, the protrusion 123 of the fuel cell carrier 12 squeezes the reservoir 9 until the layers defining the reservoir 9 separate and open the inlet 10 for the fuel. While the protrusion 123 of the fuel cell carrier 12 continues pressing on the bottom layer of the reservoir 9, at some point in time the bottom layer ruptures. This provides another relief for the fuel in the reservoir.
  • Figure 10 illustrates a cut view of the upper half of a rear portion of a medicament delivery device 100.
  • the rear cap 16 comprises a stopper 163 protruding from the cover 161 in proximal direction.
  • a length of the stopper 163 corresponds to a length of the fuel cell module of Figure 8a in longitudinal direction in the uncompressed state.
  • a manufacturer of delivery devices maybe interested in manufacturing delivery device including a fuel cell module, as well as absent the fuel cell module.
  • only a different rear cap 16 such as the one shown in Figure 10 may be used. This allows a delivery device absent a fuel cell to still provide the same basic functionality including an audible end click at the same longitudinal position x2 of the lock bracket 15.
  • FIG 11 illustrates a perspective view of a fuel cell module according to an embodiment of the present invention.
  • the fuel cell module comprises a fuel cell carrier 12, presently of cylindrical shape, with a closed front at the distal end D, and an open front at the proximal end P.
  • a fuel cell 11 is arranged in the cylindrical body of the fuel cell carrier 12.
  • a reservoir 9, such as a blister, is arranged the proximal end P of the fuel cell carrier 12, preferably on top of the fuel cell 11, and is coupled to the fuel cell 11, preferably to an inlet of the fuel cell 11.
  • This fuel cell module can be attached with its proximal end to a push button of a medicament delivery device as will be shown in more detail in Figures 12 and 13.
  • FIG 12 illustrates a side view of a medicament delivery device 100 according to an embodiment of the present invention.
  • the present delivery device 100 preferably is a manual injector. It comprises a tubular shaped enclosure 8 and a needle cover sleeve 6 protruding from the enclosure 8 at the proximal end P.
  • the needle cover sleeve 6 protects the needle (not visible).
  • the delivery device 100 comprises a push button 19 to be manually actuated by being pushed in proximal direction relative to the enclosure 8.
  • the push button 19 preferably releases a delivery of the medicament stored in a container inside the enclosure 8 through the needle.
  • a fuel cell module such as the one illustrated in Figure n, and represented by the visible fuel cell carrier 12 is attached to the push button 19.
  • the attachment is a non-releasable attachment such as by one or more of gluing, a snap fit, a press fit, or other suitable mounting means.
  • fuel cell carrier 12 and the push button 19 show a little tolerance in longitudinal direction which enables the reservoir to be compressed in response to pushing the push button 19. While a user presses the distal end D of the fuel cell carrier 12 in proximal direction, it is expected that the fuel cell carrier conveys the pushing force onto the push button 19 which in turn triggers the release of the medicament. At the same time, it is expected that the reservoir is sufficiently compressed to release the fuel into the fuel cell.
  • the cylindrical fuel cell carrier 12 may have an elastic front at its distal end allowing the fuel cell and the reservoir 9 inside the fuel cell carrier 12 to be pushed relative to and towards the push button 19, thereby effecting the reservoir being compressed and releasing the stored fuel.
  • side walls of the fuel cell carrier 12 may be stiff and be used for attaching the fuel cell carrier 12 to the push button 19.
  • the entire fuel cell carrier 12 is be made from elastic material allowing the manual force applied to the distal front be conveyed to the reservoir and pressing the reservoir against the push button.
  • Figure 13 illustrates a side view of a medicament delivery device 100 according to an embodiment of the present invention.
  • the present delivery device 100 preferably is a syringe, e.g. made from plastics except for the needle 2.
  • the syringe comprises a tubular shaped container 1.
  • the needle 2 is attached to the container 1 at its proximal end P.
  • the syringe comprises a well-known handle 82.
  • a plunger rod 13 is provided for manually pushing a medicament inside the container 1 through the needle 2.
  • the plunger rod 13 has a grip 131 that can be activated by a user’s thumb. Accordingly, in the present embodiment, the push button is represented by the plunger rod 13.
  • a fuel cell module such as the one illustrated in Figure 11 and represented by the visible fuel cell carrier 12 is attached to plunger rod 13, preferably to the grip 131 of the plunger rod 13.
  • the attachment and material variants are identical to the ones explained with reference to Figure 12.
  • Figure 14 illustrates a side view of another medicament delivery device 100, according to an embodiment of the present invention.
  • the delivery device 100 may be any of a manual injector or a syringe, in which a push button 19 is movable in proximal direction relative to an enclosure 8.
  • the reservoir 9 and the fuel cell 11 are preferably arranged in or at the enclosure 8, such as on a fuel cell carrier 12 schematically illustrated in Figure 14.
  • the push button 19 comprises a trigger member 191, e.g.
  • Step Si represents an application of the delivery device.
  • the application step Si may be represented by one of the following steps: The user preparing the delivery device for delivery of the medicament stored in the delivery device, step S11; the user initiating delivery of the medicament stored in the delivery device, step S12; the delivery of the medicament being accomplished, step S13.
  • Such application step Si automatically triggers the supply of a fuel stored in the delivery device to a fuel cell of the delivery device, in step S2. This step implies activating the fuel cell and the fuel cell generating electricity.
  • actuation data is transmitted to the outside world, via a wireless communication interface.
  • This data transmission may in one embodiment automatically be triggered in response to a sufficient generation of electricity by the fuel cell.
  • the generation of electricity may empower a processor or hardwired logic - referred to as electoral circuitry - configured to control transmission of data (and possibly other functions in the delivery device).
  • the transmission of the actuation data may also be dependent on further criteria expressed by the second arrow leading into step S3 in Figure 15.
  • the electronic functions of the delivery device may generally be shut down in response to the fuel cell no longer generating electricity at some point time.
  • the delivery device is disposed of, however, its usage was confirmed by the temporary enablement of transmitting status data such as actuation data to the outside world.
  • the drug delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.
  • Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g.
  • psoriasis psoriatic arthritis
  • spondyloarthritis spondyloarthritis
  • hidradenitis suppurativa Sjogren's syndrome
  • migraine cluster headache
  • multiple sclerosis neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age- related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti- apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti- apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin generelated peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B)
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizuma
  • Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan- nxki, pertuzumab, transtuzumabpertuzumab, alemtuzumab, belantamab mafodotin- blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90- Yttrium-ibrit
  • Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.
  • Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • adjuvant or neoadjuvant chemotherapy such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid.
  • Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
  • Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g.
  • analgesics e.g., acetaminophen
  • antipyretics e.g., antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g.
  • antiemetics e.g., ondansetron
  • antibiotics e.g., antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.
  • SWFI sterile water for injection
  • 0.9% Normal Saline 0.45% normal saline
  • 5% dextrose in water 5% dextrose in 0.45% normal saline
  • Lactated Ringer Lactated Ringer’s solution
  • Heparin Lock Flush solution 100 U/mL Heparin Lock Fl
  • compositions including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier.
  • Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, humanderived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.
  • Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, MiniCHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, REPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CAL

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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un dispositif d'administration de médicament (100) comprend une pile à combustible (11) configurée pour générer de l'électricité en réponse à une réaction chimique entre un combustible (93) fourni et un agent oxydant, un réservoir (9) rempli par le combustible (93) et agencé pour fournir le combustible (93) à la pile à combustible (11) en réponse à une application du dispositif d'administration de médicament (100), une interface de communication sans fil (18), et un ensemble de circuits électrique (17) configuré pour transmettre des données d'application par l'intermédiaire de l'interface de communication sans fil (18) en réponse à l'alimentation par la pile à combustible (11).
PCT/EP2023/083698 2022-12-13 2023-11-30 Dispositif d'administration de médicament WO2024126064A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263432173P 2022-12-13 2022-12-13
US63/432,173 2022-12-13
EP23164064.0 2023-03-24
EP23164064 2023-03-24

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030130624A1 (en) * 2002-01-07 2003-07-10 Kowalik Francis C. Medical infusion system with integrated power supply and pump therefor
EP0983101B1 (fr) * 1997-09-05 2004-10-27 Baxter International Inc. Pompe electrochimique de seringue
WO2019234573A1 (fr) 2018-06-08 2019-12-12 Centre National De La Recherche Scientifique Biopile a reservoir de combustible
WO2021094593A1 (fr) 2019-11-15 2021-05-20 Centre National De La Recherche Scientifique Dispositif de production et/ou stockage d'energie comprenant un reservoir
WO2021170826A1 (fr) 2020-02-27 2021-09-02 Centre National De La Recherche Scientifique Biopile bi-cathodique à combustible

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0983101B1 (fr) * 1997-09-05 2004-10-27 Baxter International Inc. Pompe electrochimique de seringue
US20030130624A1 (en) * 2002-01-07 2003-07-10 Kowalik Francis C. Medical infusion system with integrated power supply and pump therefor
WO2019234573A1 (fr) 2018-06-08 2019-12-12 Centre National De La Recherche Scientifique Biopile a reservoir de combustible
WO2021094593A1 (fr) 2019-11-15 2021-05-20 Centre National De La Recherche Scientifique Dispositif de production et/ou stockage d'energie comprenant un reservoir
WO2021170826A1 (fr) 2020-02-27 2021-09-02 Centre National De La Recherche Scientifique Biopile bi-cathodique à combustible

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