Patent Description:
A variety of diseases exists that require regular treatment by injection of a medicament. Typically a medical practitioner formulates a dosage regime that manages the timing and dosage of the injections a patient should follow. Thus the timing and / or the dosage of the injections can vary between patients and between injections. Often, as part of the dosage management regime, users are required to record parameters of the injections, for example to monitor effectiveness of the treatment or as feedback during the calculation of parameters for subsequent injections. This could be achieved through the keeping of a manual data logbook.

The injections can be performed either by medical personnel or by patients themselves by using injection devices. Injection devices (i.e. devices capable of delivering medicaments from a medication container) typically have a syringe connected to a medicament container and a dose dispensing mechanism for driving the medicament through the needle. The medicament chamber may be re-useable wherein the dose dispensing mechanism is designed to be reset, allowing an empty medicament cartridge to be replaced by a new one. Alternatively, the injection device may be disposable wherein, upon the contents of a pre-filled medicament container being emptied, the injection device is disposed of. Suitably, the injection device includes a dose setting mechanism that allows a user to set or 'dial in' an amount of medicament to be administered.

As an example, type-<NUM> and type-<NUM> diabetes can be treated by patients themselves by injection of insulin doses according to a dosage regime, for example injections once or several times per day. <CIT> discloses a suitable injection device typically referred to as a pen and references to pen herein are interchangeable with injection device. It is known for a disposable pen to be provided with a set of one-way needles that are attached to the pen before each use. The insulin dose to be injected and prescribed by the dosage regime can then, for instance, be manually selected through the dose setting mechanism by turning a dose knob to the required volume. The dose is then injected by inserting the needle into a suited skin portion and pressing an injection button of the dose dispensing mechanism. As part of the management of the dosage regime, the user records parameters of the injection. Such parameters, for instance, may be one or more of; the date and time of injection, blood sugar results, medication and dose, and / or diet and exercise information.

<CIT> describes an apparatus which includes a pen body of a drug injection pen including a dosage injection mechanism that produces a rotational motion when the drug injection pen dispenses a fluid. The apparatus also includes a button housing with at least part of a dosage measurement system disposed within the button housing. At least part of the dosage measurement system is coupled to receive the rotational motion from the dosage injection mechanism. The dosage measurement system includes one or more sensors positioned to output a signal in response to the rotational motion when the drug injection pen dispenses a fluid, and a controller coupled to the one or more sensors to receive the signal. A drug delivery control wheel of the drug injection pen is disposed between the body of the drug injection pen and the at least part of the dosage measurement system disposed in the button housing.

<CIT> describes a medication delivery devices having a dose delivery sensing capability. A sensed element is attached to a dose setting member of the device. The sensed element includes surface features radially-spaced from one another. A rotational sensor is attached to an actuator of the device. The rotational sensor includes a movable element that is contactable against the surface features. The rotational sensor is configured to generate a signal in response to the movement of the movable element over the surface features during their rotation. A controller is operatively coupled to the rotational sensor, and in response to receiving the generated signal, the controller is configured to determine a number of the surface features passing the movable element of the rotational sensor during dose delivery. The number can be associated with an amount of dose delivered. Sensing can be provided in a module or integrated in device.

<CIT> describes a dose setting mechanism comprising a drug delivery device housing and a dual state track provided within the housing that is axially and rotationally fixed with respect to the housing. A dose dial component is positioned in the housing and rotatable during dose setting and dose delivery. A clutch is rotatable during dose setting and non-rotatable during dose delivery. A clutch plate is rotationally fixed relative to the housing; and a clutch blocker is in threaded engagement with the clutch plate and has a radial key engaged with the dual state track. The mechanism may comprise a biasing member positioned between the clutch blocker and clutch plate.

<CIT> describes a dose tracking mechanism for a drug delivery device, including an RFID device with an electric circuit and a switch operable to open and close the electric circuit to transmit a wireless signal to a receiving device when the electric circuit is closed by the switch. The switch is configured to open and close in response to operation of a dose setting and/or a dose dispensing mechanism of the drug delivery device, and the closing and opening of the electric circuit generates a pulse of the wireless RFID signal. In one embodiment, each pulse corresponds to a unit of a dose of medicament set by the dose setting mechanism or dispensed by the dose dispensing mechanism from a drug container of the drug delivery device, depending on if the dose setting or dose dispensing mechanism is arranged to toggle the switch.

According to various aspects of the present specification there is provided an apparatus configured to be arranged within a housing of an injection device and for detecting a manipulation of the injection device, the apparatus comprising:.

By providing a contact sensor between the cam part and the follower part, the contact sensor can provide a signal in response to the reciprocating motion of the follower part. The signal can be used to determine a dose delivered by the injection device, or a dose dialled into the injection device, from the detected reciprocating motion of the follower part.

According to the exemplary embodiments, there is therefore provided an improved injection device as set forth in the appended claims. Other features of the present disclosure will become apparent from the description and elsewhere in the application. By using a sensor to monitor the movement of a part of the injection device, a dose measurement can be electronically recorded, thus providing improved dose management ability.

Exemplary embodiments are described with reference to the accompanying drawings, in which:.

Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout.

<FIG> is an exploded view of an injection device <NUM> suitable for use with exemplary embodiments. The injection device shown is often referred to as an injection pen or pen. Various designs of pen are known and whilst a brief description is given herein, it will be appreciated that the specific construction of the pen may alter and vary from the following description.

The injection device <NUM> has a distal end and a proximal end. The term "distal" refers to a location that is relatively closer to a site of injection, and the term "proximal" refers to a location that is relatively further away from the injection site.

The injection device <NUM> comprises a grip assembly <NUM>, a cap <NUM> and a needle assembly <NUM>. The grip assembly is formed from a housing <NUM> and a cartridge assembly <NUM>. The cartridge assembly <NUM> includes a cartridge holder <NUM> for containing a cartridge <NUM> containing medicament. As shown, housing <NUM> is substantially cylindrical and has a substantially constant diameter along its longitudinal axis from a proximal end to a distal end. The longitudinal axis has a proximal-distal direction that extends from the proximal end to the distal end and the reverse distal-proximal direction.

The cartridge assembly <NUM> is assembled to the housing <NUM> to form the grip assembly <NUM>. Suitably, the proximal end of the cartridge assembly <NUM> includes a connection part (not shown) and the distal end of the housing <NUM> includes a corresponding connection part (not shown) that cooperatively engage with each other to connect the two parts. As shown, the cartridge holder <NUM> is substantially cylindrical with a hollow receiving for the cartridge <NUM>. The cartridge includes a stopper <NUM> that can be advanced within the cartridge <NUM> during use to expel medicament from the cartridge <NUM>. Here, it will be appreciated that the needle assembly <NUM> cooperates with the grip assembly to serve as a conduit for the medicament during injection.

The cartridge holder <NUM> has a porthole <NUM> in a side thereof. The porthole <NUM> allows the user to view the cartridge <NUM> through the porthole <NUM> when the cartridge <NUM> is contained in the cartridge holder <NUM>. <FIG> shows a stopper <NUM> of the cartridge <NUM> visible through the porthole <NUM>. <FIG> shows the cartridge holder <NUM> having one porthole <NUM>, however, the cartridge holder <NUM> may instead have more than one porthole <NUM>. For example, the cartridge holder <NUM> may have a first porthole <NUM> located on one side of the cartridge holder <NUM> and a second porthole located on a second, in some cases opposing, side of the cartridge holder <NUM>. Thus a first side of the cartridge <NUM> within the cartridge holder <NUM> may be visible through the first porthole <NUM> while a second, different side of the cartridge <NUM> may be visible through the second porthole. Other porthole configurations may be used.

The needle assembly is shown comprising a needle <NUM>, an inner needle cap <NUM> and an outer needle cap <NUM>. A needle <NUM> of the needle assembly <NUM> can be affixed to the cartridge holder <NUM> such that the needle <NUM> is in fluid communication with the medicament in the cartridge <NUM>. The needle <NUM> is protected by the inner needle cap <NUM> and the outer needle cap <NUM>,.

The removable cap <NUM> attaches to the cartridge assembly. The cap <NUM> at least partially covers the cartridge holder <NUM>, and hence cartridge <NUM>, when attached to the grip assembly. The cap <NUM> may also be attached to the grip assembly such that it at least partially covers the cartridge holder <NUM> with or without one or more of the needle <NUM>, inner needle cap <NUM> or outer needle cap <NUM> being present.

The cartridge holder <NUM> may have a cap retaining feature <NUM> on an outer surface, for example adjacent a proximal end of the cartridge holder <NUM>, and adjacent the attachment to the housing <NUM>. Thus, the cap <NUM> may substantially cover the cartridge assembly when fitted. The cap retaining feature <NUM> engages with a corresponding coupling feature on an inner surface of the cap <NUM> to hold the cap <NUM> in place when attached to the grip assembly. The cap retaining feature <NUM> may comprise one or more of a ridge, groove, bump, lock and/or pip. In some examples, the cap retaining feature is located on the housing <NUM> of the injection device <NUM>.

As shown in <FIG>, the housing <NUM> houses a dose dispensing mechanism and a dose selection mechanism. The dose setting mechanism is used to select a dose to be injected and the dose dispensing mechanism is activated to inject the dose. In this instance, the dose dispensing mechanism is activated to drive the stopper <NUM> towards the distal end of the cartridge <NUM>. The injection device <NUM> may be used for several injection processes until either the cartridge is empty or the expiration date of the injection device <NUM> (e.g. <NUM> days after the first use) is reached. Injection device <NUM> may be single-use or reusable.

To drive the stopper <NUM> into the cartridge <NUM>, the dose dispensing mechanism includes a piston rod <NUM>, a drive sleeve <NUM>, and a trigger button <NUM>, which act together to drive a pressure plate <NUM> against the stopper <NUM> and into the cartridge <NUM>. A medicament or drug dose to be ejected from the drug delivery device <NUM> is selected by turning a dosage knob <NUM>, which is connected by a threaded insert <NUM> to a dose dial sleeve <NUM>, where rotation of the dose dial sleeve <NUM> by the dosage knob <NUM> causes the selected dose to be displayed in a dosage window <NUM> in the housing <NUM> and causes a clicker <NUM> to interact with the drive sleeve <NUM> via a spring clutch <NUM>. Together, the dosage knob <NUM>, dose dial sleeve <NUM>, and clicker <NUM> are a dose setting mechanism. The dose dial sleeve <NUM> is arranged around the clicker <NUM>, which includes a feedback mechanism <NUM> that generates a tactile or audible feedback with rotation of the dose dial sleeve <NUM>. The clicker <NUM> is coupled to the drive sleeve <NUM> with a metal clutch spring <NUM>.

A last dose nut <NUM> (LDN) is provided on the drive sleeve <NUM>. The last dose nut <NUM> advances with each dose dispensing operation to track the total medicament remaining in the cartridge <NUM>. The trigger button <NUM> is depressed to activate a dose dispensing operation of the drug delivery device <NUM>. The drive sleeve <NUM> includes flanges <NUM> and <NUM> that project from the drive sleeve. For instance, the flanges may be radial flanges. The LDN <NUM> is a threaded part, and suitably a half nut. The drive sleeve includes a threaded bolt section that typically extends between the two flanges. As the drive sleeve is rotated by corresponding rotation of the dose setting mechanism, the LDN <NUM> is caused to move along the drive sleeve by cooperation of the respective threads. The LDN is suitably arranged to move from flange <NUM>, which is a minimum flange indicating the starting position of the LDN when the LDN abuts the flange and the cartridge is full. The LDN iteratively moves along the drive sleeve as each dose is injected. The LDN advances in response to rotation of the dose setting mechanism but does not translate relative to the drive sleeve as the drive sleeve is driven during the dose dispensing operation. The LDN abuts the other flange, which is a maximum flange that prevents the LDN from moving and consequently prevents the dose dialed mechanism from dialing in a dose that would exceed the dose remaining in the cartridge.

While the dose setting mechanism is illustrated as the dosage knob <NUM>, dose dial sleeve <NUM>, and the clicker <NUM>, as described above, one skilled in the art will appreciate that any number of different dose setting mechanisms that are routine in the art for the purposes of setting a dose of a drug delivery device and aspects of the present disclosure are compatible with other such dose setting mechanisms. Similarly, while the dose dispensing mechanism is illustrated as including the piston rod <NUM>, drive sleeve <NUM>, trigger button <NUM>, one skilled in the art will appreciate that a number of different dose dispensing mechanisms (e.g., drive mechanisms) are known in the art for the purposes of delivering or dispensing a dose of a drug delivery device and aspects of the present disclosure are compatible with other such dose dispensing mechanisms.

Continuing with the operation of the drug delivery device <NUM>, turning the dosage knob <NUM> causes a mechanical click sound to provide acoustic feedback to a user by rotating the dose dial sleeve <NUM> with respect to the clicker <NUM>. The numbers displayed in the dosage display <NUM> are printed on the dose dial sleeve <NUM> that is contained in the housing <NUM> and mechanically interacts with the drive sleeve <NUM> via the metal spring clutch <NUM>. When the injection button <NUM> is pushed, the drug dose displayed in the display <NUM> will be ejected from the drug delivery device <NUM>. During a dose setting operation, the drive sleeve <NUM> is helically rotated with the dose dial sleeve <NUM> spiraling outwardly in the distal-proximal direction. When the injection button <NUM> is pushed, the drive sleeve <NUM> is released and advanced distally, which causes rotation of the piston rod <NUM>. The rotation of the piston rod <NUM> drives the pressure plate <NUM> against the stopper <NUM> of the cartridge <NUM>, which drives the stopper <NUM> into the cartridge <NUM> to expel the medicament from the cartridge <NUM>. A more detailed description of a representative drug delivery device is described in <CIT>.

<FIG> shows the drug delivery device <NUM> at the end of a dose setting operation and prior to a dose dispensing operation, where the dose dial sleeve <NUM> and the drive sleeve <NUM> have been helically rotated with respect to the housing <NUM> and a threaded end <NUM> of the piston rod <NUM> to set the dose. The last dose nut <NUM> is shown advanced along the drive sleeve <NUM> from an initial position to a position indicative of the dose remaining in the drug delivery device <NUM>. Upon dose dispensing of the injection button <NUM>, the drive sleeve <NUM> advances into the housing <NUM> and a bearing nut <NUM> induces rotation of the piston rod <NUM>. The bearing nut <NUM> sits fixed inside the housing <NUM> and has a threaded engagement with the piston rod <NUM>. As the piston rod <NUM> rotates, the piston rod <NUM> is screwed forward (relative to the housing <NUM>) because the bearing nut <NUM> cannot move. The rotation of the piston rod <NUM> drives the piston rod <NUM> and the pressure plate <NUM> proximally in the proximal-distal direction to drive the stopper <NUM> into the cartridge <NUM>. Once dispensed, the drive sleeve is in a non-dose dialed position.

A medicament dose to be ejected from injection device <NUM> can be selected by turning the dosage knob <NUM>, and the selected dose is then displayed via dosage window <NUM>, for instance in multiples of International Units (IU). An example of a selected dose displayed in dosage window <NUM> may be '<NUM>' IUs, as shown in <FIG>. It should be noted that the selected dose may equally well be displayed differently, for instance by means of an electronic display.

Turning the dosage knob <NUM> causes a mechanical click sound to provide acoustic feedback to a user. The numbers displayed in dosage window <NUM> are printed on the sleeve <NUM> that is contained in housing <NUM>. When needle <NUM> is stuck into a skin portion of a patient, and then injection button <NUM> is pushed, the medicament dose displayed in display window <NUM> is ejected from injection device <NUM>. When the needle <NUM> of injection device <NUM> remains for a certain time in the skin portion after the injection button <NUM> is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of the medicament dose also causes a dispensing clicker to provide a mechanical click sound, which is however different from the sounds produced by the clicker <NUM> when using dosage knob.

Whilst a pen injection device is briefly described, other injection devices are envisaged, as is known in the art.

<FIG> shows a dispensing clicker <NUM> comprising a cam part <NUM>, a follower part <NUM> and a spring <NUM>. The spring <NUM> is arranged to urge the follower part <NUM> against the cam part <NUM>. The cam part <NUM> is attached to the housing <NUM>.

In some examples, the follower part <NUM> may be coupled to the dose dispensing mechanism. For instance, the follower part <NUM> may be attached to the piston rod <NUM>. In such examples, the dispensing clicker <NUM> may be configured to detect a dispensed dose.

In some other examples, the follower part <NUM> may be coupled to the dose setting mechanism. In such examples, the dispensing clicker <NUM> may be configured to detect the set dose.

The cam part <NUM> is configured to be fixed relative to the follower part <NUM>. The cam part <NUM> is constrained from moving axially. The follower part <NUM> is moveable axially by compression and extension of the spring <NUM>. The follower part <NUM> is configured to rotate as the dose is being delivered during the delivery phase.

The cam part <NUM> comprises a profiled section, shown as a sawtooth profile in the Figure. The follower part <NUM> has a corresponding profile, configured to engage with the profiled part of the cam part <NUM>. The profiled sections of the cam part <NUM> and the follower part <NUM> are fully engaged in the Figure. The spring <NUM> is arranged to urge the follower part <NUM> against the cam part <NUM>. The spring <NUM> maintains the engagement between the profiled sections of the cam part <NUM> and the follower part <NUM>.

Rotation of the follower part <NUM> disengages the profiled section of the cam part <NUM> from the profiled section of the follower part <NUM>. The cam part <NUM> is fixed relative to the follower part <NUM> and is unable to rotate such that the follower part <NUM> is pushed axially away from the cam part <NUM> as it is rotated, as shown in <FIG>. An 'upslope' section of the sawtooth profile pushes the two parts apart. The spring <NUM> is compressed as the follower part <NUM> moves away from the cam part <NUM>. As the follower part <NUM> rotates further, the cam part <NUM> and the follower part <NUM> can move back together. On the 'downslope' section of the sawtooth profile, the two parts can move together. The spring <NUM> expands and urges the follower part <NUM> axially towards the cam part <NUM>.

As the follower part <NUM> continues to rotate relative to the cam part <NUM>, it is caused to move reciprocally in an axial direction. The sawtooth profile of the cam part <NUM> results in reciprocal motion of the follower part <NUM>. Each 'tooth' on the sawtooth profile may correspond to a minimum value for the dose delivery operation. That is, each tooth may correspond to a click of the dispensing clicker <NUM> associated with the ejection of the medicament dose. The follower part <NUM> may reciprocate once for each step decrease in the dosing amount as the dose is delivered during the delivery phase.

The dose detection mechanism <NUM> further comprises a piezo-electric sensor <NUM>. The piezo-electric sensor is an example of a contact sensor. As shown in <FIG>, the dose detection mechanism <NUM> may comprise an outer section, arranged radially outside the inner section shown in <FIG>. The piezo-electric sensor <NUM> may be arranged in the outer section of the dose detection mechanism <NUM>. The piezo-electric sensor <NUM> may be formed as a piezo ring which extends the outer circumference of the inner section.

In some other examples, the piezo-electric sensor <NUM> may be formed such that it does not form a complete ring. For instance, the piezo-electric sensor <NUM> may be formed in a different shape (e.g. square or rectangular) which extends around only a portion of the outer circumference of the inner section of the cam part <NUM>, as for instance, shown in <FIG>. In such examples, at least one dome may also be formed on the outer section of the dose detection mechanism <NUM>, arranged to extend around at least a portion of the outer circumference of the inner section of the cam part <NUM>. In this way, the dome(s) may ensure that the follower part <NUM> makes proper contact with the piezo-electric sensor <NUM> and/or that the follower part <NUM> is prevented from tilting when the follower part <NUM> comes together with the cam part <NUM>.

In an embodiment, the piezo-electric sensor <NUM> is attached to the cam part <NUM>. The piezo-electric sensor <NUM> is arranged to make contact with the follower part <NUM>. The follower part <NUM> may be pushed against the piezo-electric sensor <NUM> by the spring <NUM>. Alternatively, the piezo-electric sensor <NUM> may be attached to the follower part <NUM>. The piezo-electric sensor <NUM> may be arranged to make contact with the cam part <NUM>. The piezo-electric sensor <NUM> may be pushed against the cam part <NUM> by the spring <NUM>.

The piezo-electric sensor <NUM> is arranged such that the follower part <NUM> is in contact with the piezo-electric sensor <NUM> when the profiled sections of the cam part <NUM> and the follower part <NUM> are fully engaged. As the profiled section of the cam part <NUM> disengages from the profiled section of the follower part <NUM>, the follower part <NUM> is separated from the piezo-electric sensor <NUM>. In this way, the reciprocal motion of the follower part <NUM> causes the follower part <NUM> to repeatedly separate and then make contact with the piezo-electric sensor <NUM>.

The piezo-electric sensor <NUM> is configured to generate an electric voltage in response to an applied pressure. The piezo-electric sensor <NUM> generates the electric voltage in response to physical contact with another element. For example, piezo-electric sensor <NUM> in response to physical contact with the follower part <NUM>. The piezo-electric sensor <NUM> provides a sensor signal having a voltage level which is indicative of physical contact between the piezo-electric sensor <NUM> and the follower part <NUM>. The sensor signal has a high voltage level when the piezo-electric sensor <NUM> is in contact with the follower part <NUM>. In this way, the piezo-electric sensor <NUM> may produce the sensor signal with a voltage signal corresponding to the reciprocal motion of the follower part <NUM>.

Each rotation of the follower part <NUM> as the dose is delivered corresponds to one tooth on the sawtooth profile and results in a corresponding voltage peak in the sensor signal. Thus each step decrease in the dosage amount as the dose is delivered during the delivery phase results in a corresponding voltage peak in the sensor signal.

The sensor signal output by the piezo-electric sensor <NUM> is provided to an electronics system. The electronics system comprises a signal filter, an analogue-to-digital converter (ADC), a processor, a battery, and a display. The signal filter is configured to filter the sensor signal for improved processing by the ADC and the processor. The signal filter may comprise a low pass filter configured to reduce high frequency noise in the sensor signal. The signal filter may comprise a threshold filter configured to reduce low-level noise in the sensor signal.

The ADC is configured to convert the analogue sensor signal into a digital signal for processing. The ADC may convert each voltage peak generated by contact between the piezo-electric sensor <NUM> and the follower part <NUM> to a logic high, or digital "<NUM>". Otherwise, sections of the sensor signal not comprising a voltage peak may be converted to a logic low, or digital "<NUM>".

In some examples, the battery may be co-located with the processor of the electronics system. In other examples, the battery may be co-located with the piezo-electric sensor <NUM>.

The electronics system may further comprise an amplifier circuit. The amplifier circuit may amplify the voltage pulses generated by the piezo-electric sensor <NUM> as required for further processing.

In some examples, the processor may comprise a microcontroller. The processor may include an input pin which receives sensor signal from the piezo-electric sensor <NUM>. The processor input pin may be configured to trigger an interrupt in the processor in response to receiving the sensor signal such that the processor can count voltage pulses associated with a dosage delivery provided in the sensor signal. The processor may receive sensor signals directly from the piezo-electric sensor <NUM>, or may receive the sensor signals via the signal filter, the ADC and/or the amplifier circuit.

In some examples, the processor may distinguish voltage pulses in the received sensor signal associated with a dosage delivery and voltage pulses in the received sensor signal associated with external stimulus, for example, dropping of the injection device. For instance, the processor may implement signal analysis algorithms to determine differences in signal characteristics.

In some other examples, the received sensor signal may be used to "wake up" the processor. The processor may be configured to be in a sleep mode in order to preserve energy expenditure and thus battery power until it is caused to transition into an active mode. For example, in response to a first "click" associated with a dosage delivery being detected in the sensor signal, the processor may be configured to transition from the sleep mode into the active mode.

The processor is configured to count the number of voltage peaks in the sensor signal. Based on the number of voltage peaks, the processor may determine a corresponding value for the dosage amount delivered. The processor may output the determined dosage amount delivered for display on the display. Each voltage peak in the sensor signal may result in a corresponding increase in the determined dosage amount delivered. The determined dosage amount delivered may be increased by a predetermined amount, based on a minimum dosage delivery increment of the injection device. Each 'click' of the dispensing clicker <NUM> associated with the medicament dose may result in a corresponding increase in the determined dosage amount delivered.

The processor may be configured to store the currently display dosage amount in the memory. The processor may store the dosage amount along with a current time and/or date.

The injection device may further comprise a communications module in order to transmit the stored data to an external device. For instance, the communications module may provide wireless communications capabilities (e.g. Bluetooth, Wi-Fi, NFC) or wired communications capabilities. The external device may be any external device suitably for receiving the transmitted data, for instance, a smartphone, a personal computer, a server, or another smart device.

<FIG> shows an arrangement for connecting the piezo-electric sensor <NUM> with the electronics system. The electronics system, and the connections thereof as shown in <FIG>, may be arranged in the housing <NUM> of the injection device <NUM>. The electronics system and the connections thereof are therefore arranged to be fixed, relative to the piezo-electric sensor <NUM>. The piezo-electric sensor <NUM> may be electrically connected with the electronic system through contacts, for instance tracks or wires. In some other examples, the electronics system may be arranged between the housing <NUM> and the cartridge holder <NUM>.

The contacts are provided by an inner sleeve <NUM> and an outer sleeve <NUM>. For example, a first contact is provided by the inner sleeve <NUM> and a second contact is provided by the outer sleeve <NUM>. The inner sleeve <NUM> is separated from the outer sleeve <NUM> by an insulation sleeve <NUM>. The piezo-electric sensor <NUM> comprises a first conductive surface <NUM> and a second conductive surface <NUM>. The inner sleeve <NUM> is configured to make electrical contact with the first conductive surface <NUM> of the piezo-electric sensor <NUM>, and the outer sleeve <NUM> is configured to make electrical contact with the second conductive surface <NUM>. In this way, transmission of electronic signals between the electronics system and the piezo-electric sensor <NUM> can be performed via the electrical connections. Additionally or alternatively, the electronics system can provide power to the piezo-electric sensor <NUM> via the electrical connections.

As described above, reciprocal motion of the follower part <NUM> for each step decrease in the dosing amount as the dose is delivered causes the follower part <NUM> to repeatedly separate and then make contact with the piezo-electric sensor <NUM>. Thus according to the above described arrangement, electrical contact between the electronics system and the piezo-electric sensor <NUM> can be maintained during dosage delivery.

<FIG> shows a view of an alternative dosage counting mechanism. In this example, the piezo-electric sensor <NUM> is formed in a rectangular shape which extends around only a portion of the outer circumference of the inner part of the cam part <NUM>. In addition to the piezo-electric sensor <NUM>, the cam part <NUM>, as shown in <FIG>, may include at least one dome which extends around a portion of the outer circumference of the inner part of the cam part <NUM>, wherein the portion which the domes extend around may be different, and/or set apart from the portion which the piezo-electric sensor <NUM> extends around.

Although claims have been formulated in this application to particular combinations of features, it should be understood that the scope of the disclosure also includes any novel features or any novel combinations of features disclosed herein either explicitly or implicitly or any generalisation thereof, whether or not it relates to the same features as presently claimed in any claim and whether or not it mitigates any or all of the same technical problems as does the present disclosure. The applicant hereby gives notice that new claims may be formulated to such features and/or combinations of features during the prosecution of the present application or of any further application derived therefrom.

Although several embodiments have been shown and described, it would be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles of the present disclosure, the scope of which is defined in the claims.

The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body.

The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as <NPL>, for example, without limitation, main groups <NUM> (antidiabetic drugs) or <NUM> (oncology drugs), and<NPL>on.

Examples of APIs for the treatment and/or prophylaxis of type <NUM> or type <NUM> diabetes mellitus or complications associated with type <NUM> or type <NUM> diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-<NUM>), GLP-<NUM> analogues or GLP-<NUM> receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-<NUM> (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analogue" and "derivative" refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue. The added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

Examples of GLP-<NUM>, GLP-<NUM> analogues and GLP-<NUM> receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-<NUM>, Byetta®, Bydureon®, a <NUM> amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-<NUM>, CJC-<NUM>-PC, PB-<NUM>, TTP-<NUM>, Langlenatide / HM-11260C (Efpeglenatide), HM-<NUM>, CM-<NUM>, GLP-<NUM> Eligen, ORMD-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, NN-<NUM>, Nodexen, Viador-GLP-<NUM>, CVX-<NUM>, ZYOG-<NUM>, ZYD-<NUM>, GSK-<NUM>, DA-<NUM>, MAR-<NUM>, MAR709, ZP-<NUM>, ZP-<NUM>, ZP-DI-<NUM>, TT-<NUM> (Pegapamodtide), BHM-<NUM>. MOD-<NUM>, CAM-<NUM>, DA-<NUM>, ARI-<NUM>, ARI-<NUM>, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

An example drug delivery device may involve a needle-based injection system as described in Table <NUM> of section <NUM> of ISO <NUM>-<NUM>:<NUM>(E). As described in ISO <NUM>-<NUM>:<NUM>(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

As further described in ISO <NUM>-<NUM>:<NUM>(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

Claim 1:
An apparatus (<NUM>) configured to be arranged within a housing of an injection device (<NUM>) and for detecting a manipulation of the injection device, the apparatus comprising:
a cam part (<NUM>) that is configured to be rotatable relative to a follower part (<NUM>);
a resilient member (<NUM>) arranged to urge the parts towards abutment with each other wherein rotation of the cam part relative to the follower part causes reciprocating motion of the follower part, wherein the follower part is configured to move reciprocally in an axial direction of the injection device; and
a contact sensor (<NUM>) provided between the cam part and the follower part and configured to detect the reciprocating motion of the follower part,
wherein the cam part comprises a profiled section comprising an axially varying profile arranged to be in abutment with the follower part and configured to cause reciprocating motion of the follower part, and
wherein the contact sensor is arranged on the cam part and is configured to separate from the follower part upon reciprocal movement of the follower part.