Patent Description:
Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.

Drug delivery devices, such as pen-type injectors have to meet a number of user-specific requirements. For instance, with patient's suffering chronic diseases, such like diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

Typically, such devices comprise a housing or a particular cartridge holder, adapted to receive a cartridge at least partially filled with the medicament to be dispensed. The device further comprises a drive mechanism, usually having a displaceable piston rod to operably engage with a bung or piston of the cartridge. By means of the drive mechanism and its piston rod, the bung or piston of the cartridge is displaceable in a distal or dispensing direction and may therefore expel a predefined amount of the medicament via a piercing assembly, e.g. in form of an injection needle, which is to be releasably coupled with a distal end section of the housing of the drug delivery device.

The medicament to be dispensed by the drug delivery device is provided and contained in a multi-dose cartridge. Such cartridges typically comprise a vitreous barrel sealed in distal direction by means of a pierceable seal and being further sealed in proximal direction by the piston. With reusable drug delivery devices an empty cartridge is replaceable by a new one. In contrast to that, drug delivery devices of disposable type are to be entirely discarded when the medicament in the cartridge has been dispensed or used-up.

With some drug delivery devices, such as pen-type injection devices a user has to set a dose of variable size by rotating a dose dial and a dose dial sleeve in a clockwise or dose-incrementing direction relative to a body or housing of the injection device. For injecting and expelling of a dose of a liquid medicament the user will have to depress a trigger or dose button in a distal direction and hence towards the body or housing of the injection device. Typically, the user uses his thumb for exerting a distally directed pressure onto the dose button, which is located at a proximal end of the dose dial and the dose dial sleeve, while holding the housing of the injection device with the remaining fingers of the same hand.

For mechanically implemented injection devices it is desirable to enable a precise, reliable and quasi automated supervising and/or collection of injection-related data during use of the injection device. Mechanically operated injection devices may be equipped with an electronically implemented add-on device or data collection device configured to monitor user-induced operation of the injection device. A data collection device for attachment to an injection device should be rather compact with regards to its geometric size. The mechanical attachment of add-on devices or data collecting device to injection devices is rather challenging. In order to provide a precise and reliable monitoring of e.g. a mechanically implemented injection device the add-on device must be precisely positioned, e.g. on an outside surface of the injection device.

Document <CIT> discloses a drug delivery device and a monitoring device adapted to detect an action taking place in the drug delivery device. The monitoring device comprises a mounting portion with an opening for receiving a monitoring portion.

It is therefore an object to provide improve mechanical connection of an add-on device to an injection device. The mechanical connection should be universally applicable to a large variety of injection devices without the necessity to modify the geometry or structure of the injection device. The mechanical connection should provide a reliable, stable and long-lasting fastening of the add-on device to the injection device to enable a precise measuring and monitoring of injection-related parameters. Moreover, the mechanical connection should be easy to manufacture in a mass production process. It should be rather space saving and should support an energy-efficient monitoring or tracking of the operation of the injection device.

In one aspect there is provided a mounting adapter configured for mounting an add-on device to an injection device. The mounting adapter, which is defined in claim <NUM>, comprises a carrier and a first mount connected to the carrier. The first mount is configured to connect to a housing of the injection device. The mounting adapter further comprises a second mount that is connected to the carrier as well. By means of the first mount the mounting adapter itself is connectable or attachable to the housing of the injection device. By means of the second mount the add-on device is attachable and connectable to the mounting adapter. Since the first mount and the second mount are both connected to the carrier the add-on device is attachable and connectable to the injection device through and by way of the mounting adapter.

The mounting adapter further comprises an electrical conductor arranged in or on the carrier. The electrical conductor is configured to exchange at least one type of electric signals with the add-on device. Implementation of the electric conductor into a mounting adapter is beneficial in many aspects. A rather spacious electrical conductor, e.g. in form of an antenna or in form of a capacitive electrode can be arranged outside and remote from the add-on device and may be electrically connectable to the add-on device or to electrical components thereof through the mounting adapter. In this way, rather spacious and comparatively large-scaled electrical conductors can be arranged outside the add-on device. This enables to reduce the geometric size of the add-on device thus increasing a degree of user acceptance and increasing an ease of use of such add-on devices.

The mounting adapter is further beneficial in order to enable mounting of one and the same add-on device to different injection devices. For this, different types of mounting adapters each of which comprising a specifically implemented first mount complementary-shaped to differently-shaped or differently sized housings of different injection devices can be provided. In this way, one and the same type of add-on device can be used with a large variety of injection devices. For attaching the add-on device to an injection device add-on device-specific modifications to the injection device become superfluous; and vice versa.

The mounting adapter further comprises at least a first electrical contact connected to the electrical conductor. The at least first electrical contact is arranged on at least one of the second mount, an upper side of the carrier, an upper side of an electric layer and an upper side of a cover layer. Here, the optional electric layer is arranged on the upper side of the carrier. The optional cover layer extends over a major portion of the upper side of the carrier.

According to a further example the carrier of the mounting adapter comprises a sheet of an elastic foil. The sheet of elastic foil is at least one of pliable, elastically deformable or stretchable. In this way, the carrier is configured to adapt or to conform to the geometric shape of the housing of the injection device. The first mount can be integrally formed with the carrier. Hence, a portion of the carrier may constitute the first mount. In further examples the first mount may extend across or over a major portion of the carrier. The first mount may also extend over the entire carrier, typically over an underside of the carrier. In further examples the carrier may comprise a rather stiff and rigid fastening element, such as a clamp or clip configured to enclose at least a portion of the housing of the injection device.

According to another example the first mount comprises an adhesive layer arranged on or extending across an underside of the carrier. The underside of the carrier is opposite to the upper side of the carrier. The adhesive layer may comprise or may be constituted by an adhesive agent applied to the underside of the carrier. The adhesive layer may also extend across the entirety of the underside of the carrier. This enables an adhesive attachment of the carrier to the housing of the injection device, typically to an outside surface of the housing of the injection device. An adhesive layer and hence an adhesive attachment of the carrier to the housing of the injection device is universally applicable to differently sized or differently configured housings of a variety of different injection devices. An adhesive attachment does not require any modification to the geometry or construction of the injection device.

According to another example the electrical conductor is directly arranged in or on the layer. The electrical conductor can be a printed electrically conductive structure. It may be printed or directly adhered on an upper side of the carrier. In further examples the electrical conductor is implemented inside the carrier. Here, an electrical conductor may be embedded in the carrier. The carrier may comprise a laminated foil enclosing the electrical conductor. With other examples the carrier may comprise an injection molded plastic material with the electrical conductor embedded therein.

According to another example the mounting adapter further comprises the electric layer. The electric layer comprises a sheet on an electrically insulating foil arranged on an upper side of the carrier. Here, the electrical conductor is arranged on the electrically insulating foil. The electrical conductor is arranged on at least one of an underside of the insulating foil and an upper side of the insulating foil. Typically, the underside of the insulating foil faces towards an upper side of the carrier. An upper side of the insulating foil faces away from the carrier. The electrical conductor can be provided on at least one of the upper side and underside of the insulating foil. When the electrical conductor is arranged on the underside of the electrically insulating foil the electrical conductor may get in direct electrical contact with an upper side of the carrier.

With such examples the carrier itself is made of an electrically insulating material, such as plastic. It may comprise a plastic foil. Also, the electrically insulating foil may comprise a pliable, bendable or stretchable plastic foil on which the electrical conductor is printed. With other examples the electrical conductor is exclusively provided on an upper side of the electrically insulating foil. With such examples the first mount does not have to be of electrically insulating type. With this example, the carrier may comprise or may be formed of a sheet of metal.

With further examples it is conceivable, that the electrical conductor or that several electrical conductors are arranged on both opposite sides of the electrically insulating foil. One or a first electrical conductor may be arranged on an upper side of the electrically insulating foil. A second electrical conductor can be arranged on the underside of the electrically insulating foil. The first and the second electrical conductors may be electrically isolated from each other. They may be electrically disconnected from each other. The separate first and second electrical conductors may serve different purposes. A first conductor may comprise or form an electrode for measuring at least one physical parameter of the injection device. The second electrical conductor may comprise or constitute an antenna configured for a wireless transmission of data and/or wireless capturing or harvesting of electromagnetic energy. In this way, the mounting adapter may serve different electric purposes.

In further examples a first electrical conductor on an upper side of the carrier and a second electrical conductor on a lower side or underside of the electrically insulating foil are electrically interconnected. In this way a ratio of an effective length of the electrical conductor versus the geometric dimension or size of the electrically insulating foil can be increased, e.g. by a factor <NUM>.

According to another example the mounting adapter further comprises the cover layer. The cover layer extends over at least a major portion of an upper side of the carrier and covering the electrical conductor. The cover layer may be combined with different configurations of the mounting adapter. In examples where the mounting adapter is void of the electric layer and hence void of a sheet of an electrically insulating foil, the cover layer may be directly attached or arranged on the upper side of the carrier, thereby also covering the electrical conductor provided on the upper side of the carrier.

Here, the electrical conductor is located between the cover layer and the upper side of the carrier. The cover layer is typically of electrically insulating type. The cover layer may comprise or may be constituted by a pliable, elastic or stretchable plastic foil. In any example the cover layer may comprise an outer surface facing away from the carrier located underneath. The upper or outer surface of the cover layer may serve as an information surface. The outer surface of the cover layer may be provided with visual indications or visual information, e.g. regarding the type of medicament contained in the mounting adapter or regarding instructions of use regarding the medicament, the injection device and/or the add-on device.

Insofar, the cover layer provides a twofold function. It may provide information to the user and may therefore comprise an information label. The cover layer may comprise a printed label. According to another aspect the cover layer serves to protect the electrical conductor underneath and may seal and protect the upper side of the carrier against environmental influences or hazards. In particular, the information label may contain or comprise regulatory information about the drug device combination product which is formed by the injection device with a medicament container located therein.

In a further example the mounting adapter further comprises at least a second electrical contact connected to the electrical conductor or connected to a second electrical conductor. The second electrical conductor may arranged in or on the carrier and the second electrical conductor may be also configured to exchange at least one type of electric signals with the add-on device. The at least second electrical contact is arranged on at least one of the second mount, an upper side of the carrier, an upper side of the electric layer and an upper side of the cover layer.

When there are provided several electrical conductors, such as a first electrical conductor and a second electrical conductor there is also provided a respective number of electrical contacts. For instance, with a first and with a second electrical conductor there are provided first and second electrical contacts. The first electrical contact is connected to the first electrical conductor and the second electrical contact is connected to the second electrical conductor.

Both, the first and the second electrical contacts are arranged on the same or on different sides of at least one of the second mount, the upper side of the carrier, the upper side of the electric layer and the upper side of the cover layer. In this way, the at least first or several electrical contacts are accessible from outside the mounting adapter. They are in particular accessible to and for the add-on device when the add-on device is appropriately mounted on the mounting adapter. By means of the at least first electrical contact or by means of several electrical contacts, an electrical connection between the electrical conductor and the add-on device can be established. Typically, the add-on device comprises at least a first correspondingly- or complementary-shaped electrical device contact that gets in direct mechanical and electrical contact with the at least first electrical contact of the mounting adapter when the add-on device is correctly mounted on the mounting adapter.

In examples, wherein the mounting adapter is void of a cover layer and wherein the electric layer it is intended that the at least first electrical contact is arranged on at least one of the second mount and an upper side of the carrier. When the mounting adapter comprises the adhesive layer the at least first electrical contact is arranged on at least one of the second mount, the upper side of the carrier and the upper side of the electric layer. When the mounting adapter comprises a cover layer but is void of the electric layer the at least first electrical contact is arranged on at least one of the second mount, an upper side of the carrier and an upper side of the cover layer.

The at least first electrical contact may be of rather flat shape and may be entirely located in a plane in which the respective electrical conductor extends. In other examples the at least first electrical contact may protrude from at least one of a surface of the carrier, the electric layer and the cover layer. The first electrical contact may comprise a mechanical contact structure, such as a plug or socket. In other examples the at least first electrical contact may comprise an enlarged surface portion having lateral dimensions that exceed at least one dimension or cross-section of a portion of the electrical conductor. Spatially enlarged electrical contacts are beneficial to establish and electrical connection to the add-on device when the mechanical connection between the mounting adapter and the add-on device should be subject to manufacturing or mounting tolerances. At least a cross-section or a dimension of the electrical contacts is larger than manufacturing or mounting tolerances of at least one of the mounting adapter and the add-on device.

When the mounting adapter comprises a multilayer structure, e.g. when there is provided at least one of an electric layer and a cover layer on the carrier, the cover layer and/or the electric layer may comprise a through opening, through which the electrical conductor or through which the at least first electrical contact extends. It is even conceivable, that the second mount comprises a recessed portion or a through opening, through which at least one of the electrical conductor and the at least first electrical contact extends. In this way the electrical conductor buried inside or embedded in a multilayer structure of the mounting adapter can become accessible from outside the mounting adapter.

According to another example the second mount comprises a rigid mounting base. The second mount may comprise an injection molded plastic material connected to the carrier. The carrier may comprise a pliable or elastic plastic foil welded to the second mount. In some examples the carrier and the second mount may be integrally formed. They may be both made of a single injection molded plastic component.

In a further example the rigid mounting base comprises a foot and a neck. Here, the foot is connected to the carrier and the neck extends through at least one of the electric layer and the cover layer. In embodiments wherein the mounting adapter is void of the electric layer and the cover layer the neck simply protrudes from an outside surface of the carrier. The foot may be integrally formed with the carrier. When the carrier and the rigid mounting base are provided as separate components, the foot may be rigidly attached to the carrier, e.g. by an adhesive or welded connection.

Typically, the protruding neck comprises a cross-section that is smaller than a cross-section of the foot. The foot may comprise an extension along the surface of the carrier that exceeds a respective dimension of the neck with regard to the same direction. Typically, the neck is narrowed compared to the foot. The neck may comprise a longitudinal protrusion or a protruding stud or pin configured to mechanically engage with a correspondingly-shaped mount of the add-on device.

With some examples the rigid mounting base comprises a foot, a narrowed neck and a widened head. A cross-section of the head is typically larger than a cross-section of the neck. The head is arranged on an end of the neck facing away from the foot. The neck is located between the widened head and the foot.

A widened foot is of particular benefit to provide a durable, mechanically resistant and long lasting mechanical connection to the carrier, e.g. by way of an adhesive or welded connection. A head featuring a cross-section extending a cross-section of the neck is beneficial to enable a form fitting fastening of the add-on device to the second mount of the mounting adapter. The rigid mounting base, e.g. formed of an injection molded plastic material, such as a thermoplastic material, e.g. polypropylene, polyethylene or polyamide. The injection moldable plastic material might be of biodegradable type. It may may comprise or consist of a plastic material from a bioilogical source. The injection moldable plastic material provides a well-defined, e.g. a slack-free detachable fastening of the add-on device to the mounting adapter.

In some examples it is of particular benefit, when the rigid mounting base is provided on the upper side of the carrier and below at least one of the underside of the electric layer and the underside of the cover layer. For instance, at least one of the cover layer and the electric layer may comprise a recess configured to receive the neck of the rigid mounting base there through. Here, an inner diameter or cross-section of the recess in at least one of the electric layer and the cover layer is substantially identical to an outer diameter or outer cross-section of the neck.

The recess, in particular its inner dimensions may be smaller than the outer dimensions of the foot of the rigid mounting base. In this way the electric layer or cover layer may cover at least a portion of the foot when attached to the carrier. A fastening of the rigid mounting base to the carrier can be further improved by at least one of the electric layer and cover layer when at least one of the electric layer and cover layer is sufficiently fastened to the carrier.

At least one of the cover layer and electric layer or both may comprise a longitudinal slit forming a recess to receive the neck of the rigid mounting base. For this, the slit may comprise a longitudinal slit extending into a side edge of at least one of the electric layer and cover layer. The longitudinal slit may comprise a constant slit width along its longitudinal extension. Such a slit shape is beneficial for a neck having a constant cross-section along the longitudinal extension of the slit or recess of at least one of the electric layer and the cover layer.

According to another example the electrical conductor comprises or constitutes at least one of a capacitive electrode and an antenna. The electrical conductor may comprise both, a capacitive electrode and an antenna. The electrical conductor may comprise a first electrically conductive structure and a second electrically conductive structure. The first and the second electrically conductive structures may be provided on the same side of the electric layer or on opposite sides of the electric layer. The first and the second electrically conductive structures may be both connected to at least one or two electrical contacts. The at least one electrical conductor may comprise opposite ends, each end being connected to a respective electrical contact. In this way, the electrical conductor may form a conductor loop that extends along a surface of at least one of the carrier and the electric layer.

When implemented as an antenna the electrical conductor may be configured to transfer electrical signals between the add-on device and an external electronic device. The antenna may be implemented as a radio-frequency antenna. It may enable a wireless data communication between the add-on device and an external electronic device. The external electronic device may comprise a portable electronic device, such as a smartphone, a smartwatch or a tablet computer. The antenna may be configured as a near field communication (NFC) antenna that is based on the Radio-Frequency Identification Standard (RFID). In other examples, the antenna may be configured for wireless communication according to other wireless communication standards. Only as an example the antenna may be implemented as a WLAN antenna or Wi-Fi antenna in accordance to the IEEE-<NUM> standard.

When the add-on device is connected to the mounting adapter the antenna of the mounting adapter may exchange electrical signals with a communication unit of the add-on device. The antenna may be implemented as an antenna for transceiving electrical data signals. In other embodiments or examples the antenna may be configured to harvest or to capture electromagnetic energy from a surrounding electromagnetic field. It is even conceivable, that the electrical conductor comprises a first and a second antenna. A first antenna may be configured as an electric energy harvesting antenna whereas the second antenna may be exclusively configured to transceive or to exchange data with an external electronic device.

In further examples the electrical conductor comprises a capacitive electrode. In some examples the electrical conductor may comprise at least two or even more capacitive electrodes arranged at a predefined distance, e.g. on the electric layer. The capacitive electrode or the capacitive electrodes may be arranged in such a way, that different portions of the capacitive electrodes or that electrically insulated capacitive electrodes are located at diametrically opposite portions of a medicament reservoir contained inside the injection device. Such capacitive electrodes enable a quantitative measuring of the content of a medicament container.

By means of at least one or several capacitive electrodes an amount of a liquid medicament contained in a medicament container can be determined. The regular arrangement, the liquid medicament is located between two or more capacitive electrodes. In this way, the electrical conductor may be connected to a sensor arrangement of the add-on device via the respective electrical contacts when the add-on device is appropriately connected to the mounting adapter and when the mounting adapter is appropriately connected to the housing of the injection device. The amount of medicament located between capacitive electrodes is directly correlated to a measurable electrical capacity between the electrodes. In this way, a rather effective and space saving solution is provided to enable a fill level measuring of a medicament container located inside the housing of the injection device.

Simply by attaching the mounting adapter to the injection device the respective measuring electrodes are in a required position in order to conduct the respective measurement. The measuring electrodes or capacitive electrodes are thus in close proximity to the medicament container. The medicament container may for instance comprise a vitreous cartridge filled with the liquid medicament. Such a cartridge may comprise a rather elongated shape and may extend all along a cartridge holder section of the housing of the injection device. By attaching the mounting adapter all along the cartridge holder or at least at a dedicated circumferential section thereof the respective measuring electrodes may extend along the longitudinal extension of the medicament cartridge. Such a rather spacious arrangement could not be implemented into the add-on device. By arranging such measuring or capacitive electrodes in the mounting adapter no modifications are necessary to the injection device to enable such a capacity-based fill level determination of fill level measuring of the cartridge. The implementation of a measuring electrode or a capacitive electrode in the mounting adapter therefore enables to reduce the size of the add-on device.

According to another aspect the disclosure also relates to an add-on device configured for monitoring the operation of an injection device. Said add-on device is defined in claim <NUM>. The monitoring device comprises a housing with a third mount. The third mount is configured to mechanically engage with the second mount of a mounting adapter as described above.

The second mount and the third mount are configured to form or to constitute a mechanical connection. The second mount and the third mount may be correspondingly- or complementary-shaped. They may be mechanically encoded. Hence, the second mount may comprise a second mechanical code and the third mount may comprise a third mechanical code that match mutually. Another add-on device with a non-matching code cannot be attached or connected to the mounting adapter. At least one of the second mount and the third mount may comprise a plug and the other one of the second mount and the third mount may comprise a correspondingly- or complementary-shaped socket. In other examples at least one of the first mount and the second mount comprises a protrusion and the other one of the second mount and the third mount comprises a correspondingly-shaped recess.

According to another example the add-on device comprises a memory and a processor connected to the at least first electrical device contact. The memory and the processor may be arranged on a printed circuit board (PCB). The memory may be integrated into the processor. The memory may comprise both a program memory and a main memory. The processor may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. The processor is configured to execute program code (e.g. software or firmware) stored in the program memory, and uses a main memory, for instance to store intermediate results. The main memory may also be used to store a logbook on performed ejections/injections. The program memory may for instance be a Read-Only Memory (ROM), and the main memory may for instance be a Random Access Memory (RAM).

By means of the at least first electrical device contact the processor and/or the memory is electrically connectable to the electrical conductor or to various electrical conductors of the mounting adapter. In this way, an electric connection between the processor and at least one of a measuring electrode and an antenna can be established by mounting the add-on device onto the mounting adapter.

According to another example the add-on device comprises a sensor arrangement. The sensor arrangement comprises at least one of an acceleration sensor, a position sensor, a capacity sensor, an optical sensor and a magnetic sensor. The sensor arrangement may be entirely enclosed in a body or in a housing of the add-on device. In some examples the sensor arrangement or at least a particular sensor thereof may be located outside the add-on device and may be interconnected with the add-on device via the mutually corresponding electric contacts. For instance, a capacity sensor, e.g. comprising one or numerous capacitive electrodes may be formed or constituted by at least one electrical conductor arranged in or on the carrier of the mounting adapter.

In another example the add-on device further comprises a communication unit connected to the at least first electrical device contact. The communication unit is configured to transceive at least one of electromagnetic signals and electromagnetic energy via the at least first electrical conductor of the mounting adapter when the at least first electrical contact is connected to the at least first electrical device contact. The mounting adapter and the add-on device may comprise numerous, hence first, second and third electrical contacts and respective electrical device contacts that mutually correspond to each other.

The communication unit is electrically connectable through the at least first electrical device contact with the electrical conductor of the mounting adapter. Here, the electrical conductor of the mounting adapter comprises an antenna or an antenna loop. The antenna or antenna loop typically comprises a first electrical contact and a second electrical contact configured to establish an electrical connection with respective first and second electrical device contacts. The communication unit is typically configured to transceive, i.e. to receive and to transmit electrical signals via the antenna. In this way, data captured and measured by the add-on device can be transmitted to at least one or several external electronic devices by way of a wireless transmission.

In another example the add-on device is void of an own battery or electric power supply. Here, the antenna may be configured to harvest electromagnetic energy from an external electromagnetic field, e.g. from an RF-electromagnetic field. Then, the antenna and hence the electrical conductor may be connected to an electric power unit of the add-on device that is configured to derive a driving current from the electromagnetic radiation, which drive current is operable to power up and to drive the processor of the add-on device. With this example the add-on device can be implemented as a passive add-on device that is void of an own power supply. Alternatively, the add-on device may be provided with a rechargeable battery of limited capacity supporting and allowing an emergency operation of the add-on device in cases where an external electromagnetic field should not be available. If an external electromagnetic is available the battery could be recharged.

According to another aspect the disclosure further relates to an injection system. The injection system comprises a mounting adapter as described above and an add-on device as described above. The injection system further comprises an injection device featuring and comprising a housing. Here, the first mount of the mounting adapter is connected to the housing of the injection device and the third mount of the add-on device is connected to the second mount of the mounting adapter. In this way, the add-on device is connectable and mountable to the injection device exclusively via the mounting adapter. With the injection system there may be provided a number of differently-shaped injection devices.

With each injection device there may be provided a correspondingly-shaped mounting adapter. Each of these mounting adapters is configured to conform to an outside surface of the respective injection device. Each of a set of differently configured or differently-shaped mounting adapters comprises a second mount that is identical with all mounting adapters of the set of mounting adapters. In this way, the add-on device is universally attachable to any of the injection devices which is equipped with a correspondingly shaped mounting adapter. In effect, one and the same add-on device can be used with a series of different mounting adapters provided that each mounting adapter comprises a respective mount specifically-shaped to connect to the third mount of the add-on device.

In another example the injection device comprises a medicament container that is filled with an injectable medicament. The medicament container may comprise a longitudinally-shaped cartridge, e.g. a tubular-shaped cartridge that is filled with an injectable medicament. The cartridge may be pre-filled with the medicament and the cartridge may be pre-assembled inside the injection device when the injection device becomes commercially available to the customers or patients.

In the present context the term 'distal' or distal end' relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term 'proximal' or 'proximal end' relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

Exendin-<NUM> for example means Exendin-<NUM>(<NUM>-<NUM>), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-GIn-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-lle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in <NPL>, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

Antibodies are globular plasma proteins (~150kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

It will be further apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope of the claims.

Further, it is to be noted, that any reference numerals used in the appended claims are not to be construed as limiting the scope of the invention.

In the following, numerous examples of the container and of an injection device will be described in greater detail by making reference to the drawings, in which:.

The injection device <NUM> as shown in <FIG> is a pre-filled disposable injection device that comprises a housing <NUM> to which a needle assembly <NUM> can be affixed. The injection needle <NUM> is protected by an inner needle cap <NUM> and either an outer needle cap <NUM> or a protective cap <NUM> that is configured to enclose and to protect a distal section of the housing <NUM> of the injection device <NUM>. The housing <NUM> may comprise and form a main housing part configured to accommodate a drive mechanism <NUM>. The injection device <NUM> may further comprise a distal housing component denoted as cartridge holder <NUM>. The cartridge holder <NUM> may be permanently or releasably connected to the main housing <NUM>. The cartridge holder <NUM> is typically configured to accommodate a cartridge <NUM> that is filled with a liquid medicament.

As indicated in <FIG> the injection device <NUM> comprises a housing <NUM> and a container <NUM> filled with a liquid medicament. The container <NUM> provides a medicament reservoir. It may comprise a substantially tubular-shaped barrel or bottle filled with the liquid medicament. The container <NUM> may comprise a cartridge. Towards a proximal direction <NUM> the medicament reservoir <NUM> may be closed by a displaceable bung <NUM> or stopper. The bung <NUM> may be in mechanical contact with a piston rod <NUM> configured for a stepwise distally directed displacement in order to urge the bung <NUM> further in distal direction <NUM> and hence towards a distal outlet of the medicament reservoir <NUM>. At or near the outlet the medicament reservoir <NUM> may comprise a pierceable membrane. The needle assembly <NUM> comprises a threaded needle hub <NUM> configured for a screwed connection with the threaded socket <NUM> provided on a distal end of the cartridge holder <NUM>. In this way, the injection needle gains access to the interior of the medicament container <NUM>.

In <FIG> the injection device <NUM> is provided with a mounting adapter <NUM>. The mounting adapter <NUM> is shown in more detail in <FIG>. The mounting adapter <NUM> comprises a carrier <NUM>, a first mount <NUM>, a second mount <NUM> and an electrical conductor <NUM>. As shown in <FIG> the carrier <NUM> comprises a substantially planar sheet of a pliable or flexible material. The carrier <NUM> may comprise a pliable plastic foil. The carrier <NUM> comprises an upper side 102a and an underside 102b. The electrical conductor <NUM> may comprise a conductor loop and may be printed as an electrically conductive structure on the upper side 102a of the carrier <NUM>. In an alternative example the electrical conductor <NUM> may be encapsulated or embedded inside the carrier <NUM>. The first mount <NUM> is located on the underside 102b of the carrier <NUM>. The first mount <NUM> may comprise an adhesive layer extending all across our at least over a dedicated portion of the underside 102b of the carrier <NUM>. The adhesive layer may comprise or may be constituted by an adhesive agent applied on at least a portion of the underside 102b.

On the upper side 102a there is provided the second mount <NUM>. The second mount <NUM> is connected to the carrier <NUM> or is integrally formed with the carrier <NUM>. The second mount <NUM> may comprise a rigid mounting base <NUM> which is separately illustrated in <FIG>. The mounting base <NUM> comprises a foot <NUM> and a neck <NUM>. The neck extends on an upper side 114a of the foot <NUM>. The rigid mounting base <NUM> further comprises a head <NUM> connected to an end of the neck <NUM> facing away from the foot <NUM>. As illustrated in <FIG> the head <NUM> comprises a diameter or cross-section at least in one direction or dimension that is larger than a corresponding diameter or cross-section of the adjacently-located neck <NUM> in that direction or dimension.

The foot <NUM> comprises a plane-shaped underside 114b that is attached or fixed to the carrier <NUM>. The underside 114b may be adhesively attached to the carrier <NUM> or may be welded to the carrier <NUM>. For instance, the foot may be connected to the carrier by at least one of ultrasonic welding, mirror welding or warm stacking. The rigid mounting base <NUM> may comprise an injection molded plastic material whereas the carrier <NUM> may comprise a pliable plastic foil.

In the configuration of the mounting adapter <NUM> as illustrated in <FIG> the carrier <NUM> is covered by a cover layer <NUM>. The cover layer <NUM> comprises a geometry that is substantially identical to the geometry of the carrier <NUM>. The cover layer <NUM> may also comprise a pliable plastic foil or a paper-based label. The cover layer <NUM> may be adhesively attached to the upper side 102a of the carrier <NUM>. The cover layer <NUM> may be of an electrically insulating sheet material. The cover layer <NUM> covers and electrically insulates the electrical conductor <NUM> when attached to the carrier <NUM>. Here, at least one of the upper side 102a and an underside 106b of the carrier <NUM> and the cover layer <NUM> may be provided with an adhesive thus enabling an adhesive attachment of the cover layer <NUM> to the carrier <NUM>.

In the region of the second mount <NUM> the cover layer <NUM> comprises a recess 106c extending into a side edge of the cover layer <NUM>. The recess 106c comprises a longitudinal slit <NUM> having a width <NUM> perpendicular to its elongation that matches with a respective thickness or cross-sectional dimension of the neck <NUM> of the rigid mounting base <NUM> perpendicular to the elongation of the longitudinal slit <NUM> or perpendicular to the elongation of the elongated neck <NUM>. In this way, the slit <NUM> is configured to slidably receive the neck <NUM>. The neck <NUM> can be introduced from the side edge of the cover layer <NUM> and into the recess <NUM> C along a mounting direction M. The width <NUM> is narrower or smaller than the outer dimensions of the foot <NUM>. In this way and when adhesively attached or bonded to the carrier <NUM> the cover layer <NUM> helps to fasten the rigid mounting base <NUM> to the carrier <NUM>.

The cover layer <NUM> may comprise a printed label configured for an adhesive attachment to the housing <NUM> of the injection device <NUM>. The printed label is typically provided on an upper side 106a of the cover layer <NUM>. Such a label may contain or provide visual instructions, e.g. in form of pictures, symbols or text that relate to the medicament located inside the injection device and its way of use.

As further illustrated in <FIG> the mounting adapter <NUM> may be manufactured in a mass production process. The various layers of the multilayered structure of the mounting adapter may be provided on coils or rolls and may be subject to a roll-based printing process. It is particularly conceivable, that the carrier <NUM> and optionally at least one of the electric layer <NUM> and the cover layer <NUM> are initially provided on a reel, drum or coil. The production of the mounting adapter may only require minor modifications in an existing mass production process for printing labels for injection devices, such as injection pens. The cover layer <NUM> may comprise a label section <NUM> in which medicament related or device related information may be provided or printed. The label section <NUM> may be enclosed by an arc -shaped, rectangular shaped, circular shaped or oval-shaped enclosure, thus visually emphasizing the information content of the label section <NUM>.

The underside of the carrier <NUM> may be provided with an adhesive or with an adhesive layer. Here, the adhesive layer may form or constitute the first mount <NUM>. This adhesive layer may be covered with a detachable foil in order to enable a non-stick handling of the mounting adapter <NUM> before attaching the same to the housing <NUM> of the injection device <NUM>. Prior to an adhesive attachment of the mounting adapter <NUM> to the housing <NUM> it is required that the foil covering the adhesive layer is detached from the housing adapter <NUM>, thus exposing the adhesive layer and/or the first mount <NUM>.

In another example of the mounting adapter <NUM> the mounting adapter is additionally provided with an electric layer <NUM>. The electric layer <NUM> comprises a sheet of an electrically insulating foil that is arranged on the upper side 102a of the carrier <NUM>. It is arranged between the cover layer <NUM> and the carrier <NUM>. The electric layer <NUM> may comprise a pliable plastic and hence electrically insulating foil that is provided with a printed electrical conductor. In particular, a least one or several conductor loops may be printed on the electric layer.

The electrical conductor <NUM>, e.g. a first electrical conductor <NUM> may be located or printed on the upper side 104a of the electric layer <NUM>. A second electrical conductor may be arranged and/or printed on an opposite, hence on an underside 104b of the electric layer <NUM>. The electric conductors <NUM> provided on opposite sides of the electric layer <NUM> may be electrically insulated or electrically connected depending on the type of implementation of the respective electrical conductors <NUM>. The electric layer <NUM> may equally comprise a recess 104c as described in connection with <FIG>. The recess 104c may overlap with the recess 106c.

In <FIG> another example of a rigid mounting base <NUM> is illustrated. This mounting base also has a widened elongated foot <NUM>, a narrowing or narrowed neck <NUM> and a widened head <NUM>. The cross-sectional profile of the rigid mounting base <NUM> as illustrated in <FIG> is of double T-shape.

With the examples of <FIG> it is illustrated, that the mounting adapter <NUM> comprises at least a first electrical contact <NUM>. The mounting adapter <NUM> comprises at least a first electrical contact <NUM> and a second electrical contact <NUM>. The electrical contacts <NUM>, <NUM> are electrically or conductively connected to respective electric conductors <NUM> as illustrated in <FIG>.

In examples, wherein the second mount <NUM> is arranged on top of the carrier <NUM> and/or on top of an optional electric layer <NUM> the second mount <NUM>, in particular its rigid mounting base <NUM> comprises at least one recess or a through opening 114c extending through the structure of the rigid mounting base <NUM>. Here, the electrical conductor <NUM> extends through the through opening 114c of the foot <NUM> so that respective electrical contacts <NUM>, <NUM> can be provided on an upper side 114a of the foot <NUM> of the rigid mounting base <NUM>. As illustrated in <FIG> the electrical contacts <NUM>, <NUM> that are located at terminal ends of respective electrical conductors or at opposite ends of a conductor loop are provided at a sidewall section of the neck <NUM> of the rigid mounting base <NUM>.

In longitudinal direction, hence along a mounting direction M as illustrated in <FIG> the electrical contacts <NUM>, <NUM> are located at dedicated or predetermined positions. The add-on device <NUM> as illustrated in <FIG> comprises correspondingly-shaped electrical device contacts <NUM>, <NUM> that get in mechanical and electrically conducting contact with respective electrical contacts <NUM>, <NUM> of the mounting adapter <NUM> when the add-on device <NUM> is appropriately mounted to the mounting adapter <NUM>.

As illustrated in <FIG>, the electrical device contacts <NUM>, <NUM> are located on the third mount. The third mount is complementary-shaped to the second mount as illustrated in <FIG>. It comprises a head portion <NUM> and an adjacently-located neck portion <NUM>. The neck portion <NUM> and the head portion <NUM> as well as the neck <NUM> and the head <NUM> comprise a constant cross-section or profile along the mounting direction M. In this way the third mount <NUM> can be assembled and attached to the second mount <NUM> by way of a longitudinal sliding motion of the add-on device <NUM> relative to mounting adapter <NUM> along the mounting direction M. The neck portion <NUM> may form a longitudinal groove in the undersides <NUM> of the housing <NUM> of the add-on device <NUM>.

The neck portion <NUM> may be open ended towards a front face 201a of the housing <NUM> pointing in distal direction <NUM> when correctly attached to the injection device <NUM>. At the opposite end and hence in proximal direction <NUM> the neck portion <NUM> terminates at a stop 215a. The stop 215a is located at a predefined distance from an opposite end face 201b of the housing. When appropriately assembled to the mounting adapter <NUM> and when a proximal edge or proximal end face of the mounting base <NUM> gets in axial abutment with the stop 215a the mutually corresponding electrical contacts <NUM>, <NUM> and <NUM>, <NUM> are electrically connected. in other examples the neck portion <NUM> maybe open towards the proximal end, hence towards the end face 201b while it is closed or blocked by a corresponding stop towards the distal end face 201a.

When reaching a final assembly configuration as for instance illustrated in <FIG> the electrical contact <NUM> is electrically connected to the electrical device contact <NUM> and the electrical contact <NUM> is electrically connected to the electrical device contact <NUM>.

The add-on device <NUM> as illustrated in <FIG> comprises a rigid housing <NUM> to enclose various electronic components of the add-on device <NUM>. The housing <NUM> comprises an upper side <NUM> facing away from the housing <NUM> of the injection device when assembled to the injection device <NUM> via the mounting adapter <NUM>. The housing <NUM> further comprises an underside <NUM> opposite to the upper side <NUM>. As illustrated, the third mount <NUM> is located on the underside <NUM>. When the add-on device <NUM> is connected to the mounting adapter <NUM> it entirely covers the second mount <NUM>. The underside <NUM> may comprise an arc -shaped semi-tubular structure <NUM> configured to receive a portion of an outside surface of the housing <NUM> of the injection device <NUM>.

On the underside <NUM> there may be optionally provided a planar-shaped sensor, such as a capacitive sensor <NUM>. Additionally or alternatively there may be provided an optical sensor <NUM>, such as a photodiode or a camera. Additionally or alternatively there may be provided a mechanical switch protruding from the underside <NUM>. Upon mounting the add-on device <NUM> to the mounting adapter and hence to the injection device <NUM> the switch may be depressed thus turning on the add-on device or setting the add-on device <NUM> at least in a standby mode.

In <FIG> a block diagram of an injection system <NUM> is illustrated. The injection system <NUM> comprises a mounting adapter <NUM> connectable or connected to an injection device <NUM> and an add-on device <NUM> connected to the mounting adapter <NUM>. The mounting adapter <NUM> is connectable to the housing <NUM> of the injection device <NUM> by means of the first mount <NUM> located on the underside 102b of the carrier <NUM>. From the opposite side, hence from the upper side 102a of the carrier <NUM> there protrudes the second mount <NUM>. The second mount <NUM> is correspondingly-shaped to the third mount <NUM> of the add-on device <NUM>. In the region of the mounts <NUM>, <NUM> there are provided mutually corresponding electrical contacts <NUM>, <NUM>, <NUM>, <NUM>.

As further indicated in <FIG> the add-on device <NUM> comprises at least a processor <NUM> and a memory <NUM>. The processor <NUM> and the memory <NUM> may be located or arranged on a common printed circuit board <NUM>. There may be further provided a sensor arrangement <NUM>. The sensor arrangement may comprise at least one of an acceleration sensor <NUM>, a position sensor <NUM>, a capacitive sensor <NUM>, an optical sensor <NUM> and a magnetic sensor <NUM>. The sensor arrangement <NUM> may further comprise a flexible foil serving as a carrier or support for at least one of the acceleration sensor <NUM>, the position sensor <NUM>, the capacitive sensor <NUM>, the optical sensor <NUM> and the magnetic sensor <NUM>. The flexible foil may be configured for coiling around the housing <NUM>.

The add-on device <NUM> may further comprise a user interface <NUM>. The user interface <NUM> may comprise at least a visual indicator, such as a single color or multicolor light emitting diode (LED). Alternatively, the user interface may comprise a display, such as a liquid crystal display or a two-dimensional display or screen, e.g. a touch sensitive display. In addition, the add-on device <NUM> may comprise an actuation element <NUM>, e.g. in form of a push button or a rotatable wheel or element. The actuation element <NUM> may be configured to induce a wireless communication to an external electronic device <NUM> configured to communicate with the add-on device <NUM> wirelessly.

The add-on device may comprise a communication unit <NUM> configured to establish a wireless communication link to the external electronic device <NUM>. Typically, the add-on device <NUM> further comprises an electric power source <NUM>, e.g. in form of a battery. The electric power source <NUM> may be only optional. It is conceivable, that the electrical conductor <NUM> comprises or forms an antenna that is configured to harvest or to capture electric power and hence electric energy from a surrounding electromagnetic field, that may be supplied or provided by the external electronic device <NUM>. In this way, the add-on device <NUM> may be implemented as a passive electronic device that requires interaction with an external electromagnetic field in order to exchange data. It is conceivable, that the electric power source <NUM> is a rechargeable battery that can be regularly charged when the add-on device establishes an energy transferring or data transferring wireless link to the external electronic device <NUM>.

In this way, lifetime and/or storage capacity of the electric power source <NUM> can be effectively prolonged.

The processor <NUM> and its interaction with at least one or several of the sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the sensor arrangement <NUM> may be configured to enable a gesture recognition, i.e. to identify various handling steps that are conducted by a user in the course of preparing, setting and dispensing a dose of the medicament. For instance with the help of the acceleration sensor and/or a position sensor each handling step of the injection device <NUM>, e.g. removing of one of the caps <NUM>, <NUM>, <NUM> can be detected. Typical acceleration patterns recorded over time can be identified and can be combined with further information, such as points of time at which the respective accelerations or forces applied to the injection device <NUM> have been measured.

In this way, safety conclusions about a performed user step can be drawn from the data delivered by the various sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. By means of at least one of an acceleration sensor and a position sensor the gripping of the injection device, the removing of a cap, turning over the injection device, the piercing of the skin prior to an injection procedure, the injection of a dose, the removal of the injection device from the skin and the attachment of a cap to the device can be identified. By means of a suitable position sensor the attachment of a needle assembly <NUM> to the injection device as well as setting and injecting of a dose can be determined.

The processor <NUM> and its interaction with at least one or several of the sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the sensor arrangement <NUM> may be also configured to detect a start of an injection procedure, e.g. when a piston rod <NUM> of the drive mechanism <NUM> of the injection device <NUM> gets in abutment with the bung <NUM> of the cartridge <NUM>.

The position sensor may be based on a capacitive, optical, electrical or magnetic sensor principle. All of the above mentioned handling steps of the injection device can be assigned with a timestamp. If the processor <NUM> of the add-on device <NUM> should detect, that a consecutive timestamps between at least two selected identified actions or handling steps are below or above a predefined threshold the processor <NUM> may be configured to generate at least one of an audible, haptic or visual alert signal via the user interface <NUM>.

Identification of various steps of device handling may be based on a series of predefined signal patterns of the various sensors <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. Moreover, since every user or patient may be characterized by slightly different handling steps the processor <NUM> and the memory <NUM> may be switchable into a learn or teaching mode. Here, the user or patient may train an automatic handling step recognition.

The acceleration sensor <NUM> may comprise or form a non-contact sensor. The acceleration sensor <NUM> may be disposed inside or the surface of the add-on device <NUM>. Depending on the sensor technology used, a transparent window may cover the acceleration sensor <NUM> to prevent contamination and damage.

The acceleration sensor <NUM> may be configured to output signals indicative of the change in velocity of a user's hand relative to the sensor <NUM> as the user conduct a handling step of the injection device <NUM>. For instance, the output of the sensor <NUM> may be indicative of detaching or removing <NUM> of the caps <NUM>, <NUM> or <NUM>. The acceleration sensor <NUM> may be referred to as a non-contact sensor, since it is able to sense the change in velocity of a user's hand without contact between the sensor <NUM> and the user's hand.

In some examples the memory <NUM> is a separate component, while in other embodiments this memory <NUM> is integral with the processor <NUM> or integral with the acceleration sensor <NUM>. The processor <NUM> may comprise a low power processor <NUM>. It may be preprogramed with at least one acceleration profile or may have access to at least one acceleration profile indicative of a typical handling step of the injection device, such as a typical cap removal movement.

The processor <NUM> may be configured to determine the change in velocity of the user's hand relative to the acceleration sensor <NUM>. In order to identify a certain handling step of the injection device the processor <NUM> may the configured to check signals received from the sensor arrangement <NUM> against one or more acceleration profiles stored in the memory <NUM>. For instance, when the low power processor <NUM> determines that the received signals are indicative of a typical cap removal movement of the user's hand, it may automatically switch into an activation mode.

Numerous variants of the acceleration profiles described above may also be stored in the memory to account for variations in static friction force or a required pull-off force e.g. between a device component, such as <NUM>, <NUM>, <NUM> and the injection device <NUM>, and variations in the way a user performs each individual cap removal process.

The optional position sensor <NUM> may be connected to and at least partially controlled by the processor <NUM>. The position sensor <NUM> may be on or within the add-on device <NUM>. It may be directed towards a proximal end of the drug delivery device. The position sensor <NUM> is configured to output signals indicative of the position and/or orientation of the user's hand. For example, it may be possible to determine from the signals output by the position sensor <NUM>, whether the user is using his left hand or right hand to grasp the injection device <NUM> or a cap <NUM>. The memory <NUM> may store separate acceleration profiles for left and right hand removal of caps <NUM>, <NUM>, <NUM> and general device handling. The position sensor <NUM> may for example be a passive infrared sensor or a capacitive displacement sensor.

The acceleration sensor <NUM> may take a number of different forms. For example, an electromagnetic sensor which operates based on electromagnetic reflection. The sensor <NUM> may use optical or infra-red light and rely on the Doppler shift of the light reflected form the moving hand of the user to detect the acceleration. Alternatively, microwaves or radio waves may be used. These have the advantage of being intrinsically lower in energy than visible light, and may pass through an opaque section of the housing <NUM> of the add-on device <NUM>. Alternatively, the non-contact acceleration sensor <NUM> may be embodied as a capacitive displacement sensor. The proximity of the user's hand changes the capacitance detected by the sensor. In some other embodiments a capacitive displacement sensor may be used as a combined non-contact acceleration sensor <NUM> and absolute position sensor <NUM>.

Claim 1:
A mounting adapter configured for mounting an add-on device (<NUM>) to an injection device (<NUM>), the mounting adapter (<NUM>) comprises:
- a carrier (<NUM>),
- a first mount (<NUM>) connected to the carrier (<NUM>) and configured to connect to a housing (<NUM>) of the injection device (<NUM>),
- a second mount (<NUM>) connected to the carrier (<NUM>) and configured to connect to the add-on device (<NUM>), characterized by
- an electrical conductor (<NUM>) arranged in or on the carrier (<NUM>), wherein the electrical conductor (<NUM>) is configured to exchange at least one type of electrical signals with the add-on device (<NUM>), and
- at least a first electrical contact (<NUM>, <NUM>) connected to the electrical conductor (<NUM>), wherein the at least first electrical contact (<NUM>, <NUM>) is arranged on at least one of:
- the second mount (<NUM>),
- an upper side of the carrier (<NUM>),
- an upper side of an electric layer (<NUM>) arranged on the upper side of the carrier (<NUM>) and
- an upper side of a cover layer (<NUM>) extending over a major portion of the upper side of the carrier (<NUM>).