Patent Description:
There is a constant development of medicament delivery devices that are intended and designed to be used and handled by users that are not qualified nursing staff or physicians, i.e. handled by the patients themselves. Because the patients themselves handle the treatment, based on a specific treatment scheme, the physicians treating the patient have no direct information that the treatment schemes are followed as prescribed.

In order to obtain more information regarding the treatment, a number of devices have been developed that are capable of monitoring the dose delivery operations and to store this information. Some devices are also capable of transmitting the information to external storage locations that are accessible to a trained healthcare staff. This enables access to relevant dose delivery information to e.g. a physician of a patient.

Document <CIT> discloses a similar medicament delivery device as defined in the preamble of claim <NUM>.

Document <CIT> discloses a medicament delivery device that is arrangec with a number of intelligent functions that may monitor the operation of the device. Among the functions are monitoring of appliance and/or adherence of the patient and uploading of the information to a suitable storage means of a remote device, where the latter could be a remote communication network, a computer, a smart phone, personal digital assistant, etc. Information could also be downloaded to the medicament delivery device to be accessible to the user, such as if the drug of a medicament in the device has been recalled by the manufacturer of the drug, that the drug has expired or updated user information. In this regard, the device is arranged with a number of switches that are activated during different functional stages.

In order for the device to function it is energized before use by pressing a start button, thus requiring a specific handling step in order to be able to use the device. Further, when the device is energized, its different electronics components and many functions will consume energy. This may be a pronounced drawback if the device is energized but not used directly for some reason. There is further a risk that the start button is operated unintentionally, thereby energizing the device by accident. If the device then is to be used at a later state, the power source of the device may be depleted of power.

The aim of the present invention is to remedy the drawbacks of the state of the art medicament delivery devices. This aim is obtained by a medicament delivery device comprising the features of the independent patent claim. Preferable embodiments of the invention form the subject of the dependent patent claims.

According to one aspect of the invention the medicament delivery device may comprise a housing, which housing is arranged to accommodate a medicament container. Further a drive mechanism is arranged, capable of, upon activation, acting on the medicament container for expelling a dose of medicament.

A communication unit is associated with the housing. This means that the communication unit may be integrated in the medicament delivery device or arranged as a separate unit connectable to the medicament delivery device. The communication unit may have a number of features and functions that enable communication between the medicament delivery device and the surroundings; from direct communication with the user to wireless communication with remotely located receivers and transmitters of information, such as e.g. via the internet.

The medicament delivery device comprises a switch, which is operably connected to the drive mechanism and connected to the communication unit for activating the communication unit when operated. In this respect it is an advantage that the switch is operated by the drive mechanism at the end of a dose delivery sequence. This feature provides the advantage that the medicament delivery device does not have to be activated beforehand by a specific activation operation. This reduces the number of handling steps required by the user in that the switch is operated at the end of dose delivery. Further, the energy consumption is reduced in that the medicament delivery device is non-activated or "dead" until a dose of medicament has been delivered.

The drive mechanism comprises a force element, which force element enables said drive mechanism to operate said switch. The force element enables an automatic operation of the drive mechanism such that the user does not have to perform the dose delivery manually. In that respect, the force element may be a drive spring arranged to act on and move a plunger rod of the drive mechanism in a proximal direction. In order to utilize the built-in force of the drive spring, it is arranged to act in a distal direction at the end of the dose delivery sequence. Thereby the residual force of the drive spring is used for activating the switch so that the communication unit is activated. Thus, no additional force elements are needed for operating the switch.

The spring may be arranged to act on a switching element, where the switching element is arranged to be released at the end of the dose delivery sequence and to act on the switch. This solution entails a holding or locking of the switching element until the dose of medicament has been delivered. In this respect, the distal end of the drive spring may be in contact with, and act on the switching element, and when the dose has been delivered, the switching element is released and is forced in the distal direction by the drive spring, wherein the switching element is moved in contact with the switch.

As a variant, a plunger rod driver is used, wherein the drive spring is arranged to act on the plunger rod driver of the drive mechanism, such that the plunger rod driver is moved in a proximal direction acting on the switching element at the end of the dose delivery sequence. Here the contact between the plunger rod driver and the switching element causes the switch to close.

The communication unit may be arranged to communicate in a number of different ways. According to one simple and robust solution, the communication unit is arranged to communicate directly with a user. Thus, at the end of the dose delivery operation, the device may provide the user with specific information that is stored in the communication unit. The information may be audibly and/or visually presented to the user.

As an alternative, the communication unit may be arranged to communicate via a smart device. With this solution, the functionality of the smart device is used for informing the user. Thus, the end of dose operation may trigger the smart device to provide information audibly and/or visually to the user. With this solution the medicament delivery device may require fewer components and functions than if the device was to communicate directly. Regarding communication with external receivers, the medicament delivery device may be arranged with communication elements that are capable of communicating with wireless networks, comprising transmitting and receiving data. If designed such, then the medicament delivery device may transmit information regarding functions and events to for example a physician or a medical centre so monitoring the user's medicament handling and e.g. compare it with prescribed treatment schemes.

In that respect, and in order to increase the information obtainable, the communication unit may be operably connected to a number of sensors of the medicament delivery device. For example, the sensors may comprise functions that can derive information from the medicament container. The information may then be stored in many ways, such as EAN-codes, QR-codes or RFID-chips. The information from the medicament container may then be compared with information stored in databases, such as date of manufacture, batch number, date of expiry, etc. The comparison could then be used to alert the user that the date of expiry has passed and that the medicament container should be replaced with a new, that the batch has been re-called, whereby the medicament container should be discarded or sent back to the manufacturer, just to mention a few functions.

Other types of sensors may be set dose size sensors that are capable of sensing the dose that the user has set if the device is provided with such functions. Again, the set, and used, dose sizes may then be transmitted and compared with required dose sizes according to the treatment scheme. The collection of data from the medicament delivery device by the communication unit may thus be used to monitor patient adherence. In that respect, the communication unit may be arranged to obtain information regarding patient adherence, which may be communicated to the user.

In order to effectively handle the information obtained from the sensors of the device as well as the information obtained from outside and transmitted to the communication unit, it may preferably comprise data storage means. With this solution, data obtained when the medicament delivery device is used can be stored and does not have to be transmitted directly. That may be an advantage if for instance the medicament delivery device is used in a location where no communication connection can be established. The data is then firstly stored and then later transmitted to external receivers when a communication connection can be established.

According to a specific solution of the medicament delivery device, the communication unit may comprise a function for automatic connection with an emergency call centre. This may be advantageous if the medicament delivery device is designed as an emergency device that only is to be used when there is a crisis for a user, such as an allergic attack where there is a risk for anaphylaxis. The medicament delivery device may then alert an emergency call centre, wherein a connection is obtained automatically. In that respect, the communication unit may comprise a loudspeaker and a microphone for enabling speech information between user and emergency call centre.

Further, the communication unit may also comprise a positioning function, capable of obtaining the geographical position when the switch is activated, and being capable of transmitting said geographical position to the emergency call centre. This enables the emergency call centre to send appropriate paramedic help to the location of the user in need.

These and other aspects of, and advantages with, the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings.

In the present application, the term "distal part/end" refers to the part/end of the device, or the parts/ends of the members thereof, which under use of the device, is located the furthest away from a delivery site of a patient. Correspondingly, the term "proximal part/end" refers to the part/end of the device, or the parts/ends of the members thereof, which under use of the device is located closest to the delivery site of the patient.

In the following description, the wording smart devices will be used. In this context, smart devices may include electronic devices that are provided with processors that are capable of running computer programs as well as storage space to store programs as well as data retrieved from different external sources. It is further to be understood that the smart devices are provided with communication systems that are capable of communicating with data networks in order to access different databases. It is to be understood that databases may be accessed via the internet, so called cloud services, and/or databases that are connected directly to and accessed via local area networks. It is further to be understood that the smart devices in this context comprise some sort of human-machine interface for two-way communication. The human-machine interface may comprise displays, keyboards, microphones, loudspeakers, I/O-ports for connection of peripherals. Further the smart devices may be provided with antennas for wireless communication with the networks. Also, the smart devices may be arranged with receiving and transmitting mechanisms capable of communicating with NFC tags as well as programs capable of establishing and handling the communication with the NFC tags.

Further, in the following description, the wording medicament delivery device will be used. In this context, medicament delivery devices may include a number of devices capable of delivering certain doses of medicament to a user, such as e.g. injection devices with or without injection needles, inhalers of all kinds, such as powder, aerosol driven, gas, nebulizers having mouth or nasal pieces, dispensers for medicament in tablet form, eye dispensers, etc. The medicament delivery devices may be of either disposable type or re-usable type and may be provided with medicament containers suitably arranged for specific drugs in specific forms.

As seen in <FIG>, a medicament delivery device comprising the present invention may comprise a tubular housing <NUM> having a proximal end <NUM> and an opposite distal end <NUM>. The housing <NUM> may further comprise a container holder <NUM> which is coaxially arranged within the housing for holding a medicament container <NUM>, <FIG>. The medicament delivery device further comprises an end cap <NUM> fixedly attached to the distal end <NUM> of the housing.

As seen in <FIG>, the medicament delivery device may further be arranged with a tubular activation member <NUM> in the form of a medicament delivery member guard. The activation member <NUM> may be arranged with first co-acting elements <NUM>, which in an exemplary embodiment are two protrusions, which are used for activating the medicament delivery device as will be described in detail below. According to an embodiment of the invention, a tension spring <NUM> is arranged at the proximal end of the activation member <NUM> for moving it in a proximal direction.

<FIG> illustrates the interior of the medicament delivery device. The medicament container <NUM> is arranged within the container holder <NUM> and has a predetermined volume of medicament, a slidable stopper <NUM> and a medicament delivery member <NUM>. The medicament container <NUM> may be a syringe provided with a needle <NUM> as the delivery member; however the invention should not be limited to this. The medicament delivery device may also comprise a tubular rotator <NUM>, <FIG>, comprising grooves <NUM> on its outer surface interactively connected to the protrusions <NUM> of the medicament delivery member guard <NUM>, <FIG>.

Further the medicament delivery device comprises a drive mechanism <NUM>, <FIG>. The drive mechanism comprises a plunger rod <NUM> and a compression spring <NUM> arranged within the plunger rod <NUM>. The plunger rod <NUM> comprises a cut-out/recess <NUM>, <FIG>, interactively connected to inwardly directed protrusions <NUM> on proximally directed flexible arms <NUM> of an actuator <NUM>, <FIG>. The proximal end of the plunger rod <NUM> is in contact with the slidable stopper <NUM>. The rotator <NUM>, <FIG>, is rotatably and coaxially arranged around the actuator <NUM>, acting on the flexible arms <NUM>.

The drive mechanism <NUM> further comprises a switching element <NUM>, the purpose of which will be described below. In the illustrated embodiment, the switching element <NUM> comprises an elongated u-shaped bracket, provided with at least two elongated arms <NUM>, directed in the proximal direction, and a lower part <NUM>, a distal transversal end wall, directed in the distal direction of the medicament delivery device. The switching element <NUM> may be made from metal, plastic, or any combination of these materials.

The proximal ends of the arms <NUM> of the switching element <NUM> are provided with angled support protrusions <NUM> extending in generally radially outward directions with regard to a longitudinal axis of the switching element <NUM>. The arms <NUM> of the switching element <NUM> are arranged to extend along the length of the plunger rod <NUM>, <FIG>, and the support protrusions <NUM> are adapted to rest on a proximally directed end surface <NUM> of the actuator <NUM> when the plunger rod <NUM> and the compression spring <NUM> are in a tensioned state, i.e. the inwardly directed protrusions <NUM> of the flexible tongues <NUM> of the actuator <NUM> are positioned in the recesses <NUM> of the plunger rod <NUM>. When the plunger rod <NUM> and the compression spring <NUM> are in the pre-tensioned state, the distal end of the switching element <NUM> is arranged at a predetermined distance "D", <FIG>, from an inner distal surface of a switch <NUM>, the function of which will be described in detail below.

The device is intended to function as follows. The user presses the proximal end of the device with the medicament delivery member guard <NUM> against a dose delivery site and when an injection needle is used as medicament delivery member <NUM>, a penetration is performed on the user's skin. The penetration causes the housing <NUM> to be moved in the proximal direction in relation to the medicament delivery member guard <NUM>. This in turn causes the protrusions <NUM> of the medicament delivery member guard <NUM> to move in the grooves <NUM> of the rotator <NUM> such that the protrusions <NUM> will come in contact with inclined groove sections <NUM>i, which will cause the rotator <NUM> to turn around the longitudinal axis of the medicament delivery device.

The turning of the rotator <NUM> will activate the drive mechanism <NUM> in that the arms <NUM> of the actuator <NUM> are freed. The arms <NUM> may then flex outwardly, whereby the inwardly directed protrusions <NUM> of the arms <NUM> are moved out of contact with the recesses <NUM> of the plunger rod <NUM>. The drive spring <NUM> of the plunger rod <NUM> now urges the plunger rod <NUM> in the proximal direction for expelling a dose of medicament through the medicament delivery member <NUM> until the stopper <NUM> of the medicament container <NUM> reaches its most proximal position.

When the stopper <NUM> has been moved by the plunger rod <NUM> to almost the proximal end inside the medicament container <NUM>, the plunger rod <NUM> is moved out of contact with the arms <NUM> of the switching element <NUM> as seen in <FIG>. The arms <NUM> of the switching element <NUM> are thus free to flex inwards such that the support protrusions <NUM> are moved out of contact with the surfaces <NUM> of the actuator <NUM>, and due to the force of the compression spring <NUM> in contact with and acting on the lower part <NUM> of the switching element <NUM>, the switching element <NUM> will be moved suddenly in the distal direction the distance D until the distal end of the switching element <NUM> hits the switch <NUM>, thereby activating the switch <NUM>, <FIG>. The activation of the switch will in turn activate a communication unit <NUM>, i.e. powering the communication unit. The function of the communication unit will be described in detail below.

It is to be understood that the switch may have a number of different designs depending on the type of device and its operating components as well as the kind of signal that is to be obtained. <FIG> and <FIG> show one type of switch that can be used with the switching element described in connection with the above embodiment.

Here a distal end of the actuator <NUM> is arranged with an end wall <NUM>, provided with a generally rectangular cut-out <NUM>. On opposite sides of the cut-out, two proximally directed, somewhat inclined, contact surfaces <NUM> are arranged, which surfaces the switching element <NUM> will hit when released. The inclined contact surfaces are provided with conductive material. The conductive material extends through the cut-out <NUM> as leads <NUM>, wherein suitable conduits <NUM>, <FIG>, are connected to these leads <NUM> and then extend to the communication unit <NUM>. Further, the switching element <NUM> may be made of metal, such that when the switching element <NUM> is moved in contact with the contact surfaces <NUM>, the switch is closed. As an alternative the distal end surface <NUM> of the switching element may also be covered with conductive material. The contact surfaces <NUM> may further be arranged with protrusions <NUM>, <FIG>, in order to enhance the contact reliability between the switching element <NUM> and the contact surfaces <NUM>. <FIG> show when the switching element is moved in contact with the contact surfaces.

<FIG> and <FIG> display another embodiment of a switch to be used with the medicament delivery device described above. Also here, the actuator is arranged with an end wall <NUM> at its distal end. The end wall <NUM> is arranged with a generally rectangular cut-out <NUM>. One proximally directed, somewhat inclined, contact surface <NUM> is arranged adjacent one edge of the cut-out. The contact surface is arranged with conductive material, which extends through the cut-out as a lead <NUM>, wherein a suitable conduit is connected to this lead, which conduit is connected to the communication unit <NUM>. Further, a contact element <NUM> is arranged. It comprises a tongue <NUM> of a flexible material extending into the interior of the actuator with an inclination α in relation to a normal of the longitudinal axis L of the medicament delivery device when in unaffected, initial, position. Further, in the unaffected, initial, position there is a certain gap between the free end of the tongue <NUM> and the contact surface <NUM>. Even though the tongue <NUM> is arranged to be flexible it is understood that it should be so rigid that the tongue <NUM> cannot be moved in contact with the contact surface if the medicament delivery device is dropped on the floor for instance.

The tongue <NUM> is attached to, or made integral with, a generally tubular seat <NUM> surrounding a distal part of the actuator <NUM>. The seat <NUM> is further arranged with conductive material and is connected to the communication unit <NUM> via a suitable conduit <NUM>. When the switching element <NUM> pushes on the tongue <NUM> in the distal direction with its lower part <NUM>, whereby the tongue <NUM> is moved in contact with the contact surface <NUM> and the switch is closed, as seen in <FIG>. In this embodiment, the switching element may be of any suitable material; it does not have to be made of metal.

Regarding the contact surfaces and the leads of the embodiments described above, they can be created in many ways. They can be made by thin conductive sheet material that is bonded to components in suitable ways, such as gluing. As an alternative, the Laser Direct Structuring (LDS) technology may be utilized in creating conductive surfaces on different components. In this regard, the switching element of the first switch embodiment may be of a non-conductive material, where the distally directed end surface is treated with a conductive material, for instance with LDS.

<FIG> disclose a second embodiment of a medicament delivery device not forming parts of the present invention. The embodiment shown in the drawings comprises a generally elongated main housing <NUM> having a distal end <NUM> and a proximal end <NUM>, <FIG>.

The housing <NUM> is designed to accommodate a medicament container <NUM>, <FIG>. An appropriate medicament delivery member <NUM>, <FIG>, is attached to, or made integral with, the medicament container <NUM>. A movable stopper <NUM> is further arranged inside the medicament container, <FIG>.

Surrounding the medicament container <NUM> and coaxial therewith is a medicament delivery member shield <NUM>, <FIG>. The medicament delivery member shield <NUM> can move in the longitudinal direction in relation to the housing <NUM>.

The device further comprises a drive mechanism <NUM>, <FIG>. The drive mechanism <NUM> comprises a plunger rod driver <NUM> arranged axially moveable within the housing <NUM>. The proximal end of the plunger rod driver <NUM> is operably connected to a distal end of an elongated plunger rod <NUM>, <FIG>.

The drive mechanism <NUM> further comprises a drive spring <NUM>, here in the form of a helical coil spring, <FIG>, which biases the plunger rod driver <NUM> towards its proximal end position. A manually operated release button <NUM>, for releasing the plunger rod driver <NUM> of the drive mechanism <NUM> from the distal, or cocked, position to the proximal, or extended, position is arranged extending through the housing <NUM>, <FIG>. The release button <NUM> is operably connected to a drive mechanism locking element <NUM> which locks and interworks with the plunger rod driver <NUM> via a proximally directed ledge <NUM> positioned in a groove <NUM> to hold the plunger rod driver <NUM> with the drive spring <NUM> in the tensioned state.

According to the second embodiment, the drive mechanism <NUM> is arranged with a switching mechanism. It comprises a switching element <NUM>, <FIG>, comprising an elongated tubular body <NUM>, provided with a circular end plate <NUM> with a proximally directed end surface, which is intended to be in contact with a distally directed end surface of the plunger rod <NUM>. Further, the side surface of the body <NUM> of the switching element <NUM> is arranged with a circumferential groove <NUM>, <FIG>. The body <NUM> is arranged to fit into a central passage <NUM> of a tubular element <NUM> attached to a proximal area of the plunger rod driver <NUM>, <FIG>.

The tubular element <NUM> is arranged with a proximally directed annular switch <NUM> at the proximal end of the plunger rod driver <NUM>, <FIG>. The switch <NUM> can be of many different configurations and designs. For example, the switch <NUM> may be a piezo-electric element capable of providing an electric signal when mechanically affected. Further, the switch can also be a mechanical contact having electric contact points that are brought in contact when the switch is mechanically affected as will be explained below. The switch <NUM> is further connected to a microcontroller <NUM> of a communication unit <NUM> of the medicament delivery device, <FIG>, arranged to perform a number of functions as will be described.

The area of the plunger rod driver <NUM> proximal of the switching element <NUM> has a diameter somewhat larger than the diameter of the end plate <NUM>, such that the latter may fit into the proximal end of the plunger rod driver <NUM>, as seen in <FIG>.

Preferably the device is arranged with a switching delay mechanism. It comprises a friction enhancing element <NUM> intended to fit into the circumferential groove <NUM> of the switching element <NUM>. In the embodiment shown the friction enhancing element is an O-ring made of a resilient material such as rubber. The central passage <NUM> of the tubular element <NUM> is arranged with a first section <NUM>, <FIG>, having a diameter somewhat smaller than the diameter of the O-ring when fitted into the circumferential groove such that the O-ring is compressed when placed in the first section <NUM>. The central passage is further arranged with a second section <NUM>, <FIG>, which has a diameter that is slightly larger than the diameter of the O-ring, the function of which will be described below.

Further, a switching mechanism for the release mechanism is provided on the plunger rod driver <NUM>. It comprises two arms <NUM>, <FIG>, attached to the plunger rod driver <NUM> and extending in the proximal direction, where the arms <NUM> are positioned on opposite sides of the central passage <NUM>. Each arm <NUM> is arranged with a generally radially inwardly directed ledge <NUM>. The inwardly directed ledges <NUM> are arranged to extend into the central passage <NUM>. Further the arms <NUM> are arranged with generally radially outwardly extending ledges <NUM>, the function of which will be described below.

This second embodiment is intended to function as follows. When to be used, the proximal end of the medicament delivery device is pressed against a dose delivery site. The user depresses the trigger button <NUM>, whereby the drive spring <NUM> is released. The plunger rod driver <NUM> and the drive spring <NUM> then acts to force the plunger rod <NUM> in the proximal direction acting on the stopper <NUM> inside the medicament container <NUM>. Since the medicament is incompressible and the passage through the medicament delivery member <NUM> is narrow, the medicament container <NUM> will be moved in the proximal direction. The movement of the medicament container <NUM> will now cause a penetration of the medicament delivery member <NUM> into the skin of the user.

The force of the drive spring <NUM> now forces the plunger rod <NUM> in the proximal direction in relation to the medicament container <NUM>, moving the stopper <NUM> in the proximal direction, whereby a dose of medicament is delivered into the body of the user. When the plunger rod <NUM> is moving in the proximal direction, so is the switching element <NUM>. This is due to the arms <NUM> being forced radially inwards due to the outwardly directed ledges <NUM> being in contact with an inner surface of the medicament delivery member guard <NUM> as seen in <FIG>. The inwardly directed ledges <NUM> of the arms <NUM> are then abutting a distally directed surface of the end plate <NUM> of the switching element <NUM>.

When the plunger rod driver <NUM>, the switching element <NUM>, the plunger rod <NUM> and the stopper <NUM> have reached a position close to the proximal end position of the stopper <NUM>, the outwardly directed ledges <NUM> of the arms <NUM> will enter cut-outs <NUM> of the medicament delivery member shield <NUM>, <FIG>. The arms <NUM> are then free to move radially outwardly when the outwardly directed ledges <NUM> enter the cut-outs <NUM>. Thereby, the inwardly directed ledges <NUM> will be moved out of contact with the end plate <NUM> of the switching element <NUM>.

The force of the drive spring <NUM> will continue to urge the plunger rod driver <NUM> in the proximal direction in relation to the switching element <NUM>. However, the relative movement between the plunger rod driver <NUM> and the switching element <NUM> is slowed due to the friction enhancing element <NUM> frictionally acting on the inner surface of the tubular element <NUM> of the plunger rod driver <NUM>. The friction also aids in transferring some force to the plunger rod <NUM>, ending the injection sequence.

The relative movement continues between the plunger rod driver <NUM> and the switching element <NUM>. When the friction enhancing element <NUM> has been moved along the first section <NUM> it reaches the second section <NUM>, as seen in <FIG>. Now the friction enhancing element <NUM> is moved out of contact with the inner surface of the tubular element <NUM>. As seen, the distally directed surface of the end plate <NUM>, is positioned a distance d from the switch <NUM> as seen in <FIG>. The force from the spring <NUM> still acts on the plunger rod driver <NUM> and since it now can move freely, it will accelerate in the proximal direction the distance d until the distally directed surface of the end plate <NUM> comes in contact with the switch <NUM>, as seen in <FIG>. The switch then activates the communication unit <NUM> of the medicament delivery device.

According to the invention, the activation of the device may cause a number of functions to be performed, all depending on the intended and desired use of the device.

According to one aspect of the invention the switch, when activated, will for example trigger the microcontroller <NUM> of the communication unit by connecting it to a suitable power source <NUM> arranged in the device, <FIG>. A power source may e.g. be a battery such as a button cell or the like. Other types of power sources may be piezo elements, solar cell panels or the like. The microcontroller <NUM> is arranged to control at least one electronics module <NUM> of the communication unit <NUM>, <NUM> that may be arranged with different types of sensors. The electronics module may also be energized by the power source.

The electronics module may now perform a number of different functions either alone or in combination with other functions. One basic function that the electronics module may perform is to communicate directly with the user of the device. This communication may be done visually, e.g. by text stored in the electronics module that is displayed on a suitable display <NUM> on the device. In addition to, or instead, the communication may be performed audibly, e.g. by a recorded message stored in the electronics module that is played in an appropriate loudspeaker <NUM> of the electronics module or of the device as such.

In this regard, the electronics module may be arranged with a communication module that is capable of communicating with other devices, preferably wireless. Feasible communication systems are Bluetooth, ANT, mobile communication systems such as GSM, <NUM>, <NUM>, wlan etc, such that the device may communicate its status to a suitable receiver.

A suitable receiver may be databases set up for handling information from medicament delivery devices. The databases may be set up to communicate back to the user via the communication unit of the medicament delivery device, providing the user with specific information. In this respect, the information may be transmitted from the databases via the wireless networks, or may be stored beforehand in the communication unit and activated by a transmitted signal from the databases.

Regarding the information that the user may receive, either stored or received on activation, may be of different nature depending on the type of device, user prescription, type of drug, etc..

For example, if the device is a disposable injection device, the user may then be prompted to discard the device in a safe way, e.g. placing it in a safe container. In addition, the information may ask the user to attach a protective cap on the medicament delivery member in order to avoid damages. On the other hand, if the device is a reusable, the information may be to replace the used medicament container with a new container in order to make the device ready for a subsequent dose delivery. Also, the user may be prompted to remove the used medicament delivery member and to replace it with a new, sterile medicament delivery member.

The user information may further comprise an indication when the next dose should be taken, based on pre-determined prescription scheme. This scheme may be stored in the electronics module, or in the smart device or in the cloud and down-loaded to the medicament delivery device or the smart device upon activation. Other types of information may be how to store the medicament delivery device regarding temperature and/or light exposure.

The information from the electronics module may include features that are important to for example a physician of the patient/user. The information may then include event data such as time and date when the medicament was delivered to the user. In this respect, the activation of the electronics module may trigger the recording/logging of the date and time of the activation. This storage may be done in the electronics module if it has the means of obtaining such information from outside the medicament delivery device. Further, the information may be stored on the internet in that a signal from the electronics module, either direct or via a smart device, will trigger a time and date registration on a computer or in a database connected to the internet.

Event data may further include replacement of a used medicament container with a new medicament container. In that respect, when the medicament delivery device has been activated by the switch, a number of sensors can be used and activated in the medicament delivery device. For example, a sensor may be arranged that is capable of sensing the presence of a medicament container. In its simplest design, the sensor may be a proximity sensor or even a contact switch that is affected by the presence and/or removal of a medicament container.

The sensor may further be more intelligent in that it may be capable of deriving certain information. In that respect, the medicament container may be arranged with information that is specifically connected to the drug inside the medicament container. The information may comprise the type of drug, the concentration or strength of the drug, the expiry date of the drug, if there are any temperature requirements, etc. This information may be stored in appropriate ways on the medicament container, preferably such that it cannot be tampered with or compromised. The information may for example be arranged on a label that is firmly attached to the outer surface of the medicament container. The information may then be presented in different forms such as EAN-code, QR-code or the like readable code.

The medicament delivery device may in that respect be arranged with appropriate sensors or readers that are capable of deriving information from those types of code. The labels may instead be arranged with radio-frequency chips or RFID-chip, and suitably NFC-chips. The sensors are then arranged to read the chips and to derive information stored thereon. This information may then be communicated to either a smart device and/or to wireless networks. Further, the use of NFC-chips enables the reading of the chip by a smart device, if the latter is arranged with a function enabling reading of NFC-chips. Further, instead of using labels, the NFC-chips may be embedded in the material of the medicament container in order to further minimize the risk of manipulating the information.

Regarding temperature, there is a possibility of obtaining information regarding if the medicament container has been exposed to temperatures outside certain approved ranges in that the NFC-chip is provided with temperature sensors. Should the medicament container have been exposed to temperatures outside the approved, this may be read from the NFC-chip.

The triggering of the medicament delivery device by the end of dose switch may provide further information. For instance, the electronics module may be arranged with a positioning function whereby the geographical position of the user may be obtained and used for different purposes. In this respect, the positioning may be obtained by different functions. Either the electronics module is provided with a GPS-function, whereby the actual position of the user when the dose is delivered is recorded by GPS coordinates. Another possibility is to use the GSM-function for locating the position. The GPS-function and the GSM-function may further be combined with a WIFI location function for improved indoors location.

The accuracy of the positioning function is dependent on the purpose of the location information. For instance if it is important to know if the drug is used in the right country, for instance to be able to track that the drug is not imported or sold to others if the user has received the drug for free or with large subsidies, then it is only necessary to obtain country-based positioning information. In that case the GSM-function may be used to obtain information in which country the medicament delivery device is used.

On the other hand, if the medicament delivery device is a so called emergency device, which is to be used only when an emergency occurs like for instance if a patient suffers an allergic attack that results in an anaphylaxis, then the positioning accuracy may be important. The anaphylaxis may be treated by epinephrine and several patients have been provided with auto-injectors filled with epinephrine. However, if such a medicament delivery device was used, there is still a risk that the patient needs further care if for instance the injection of epinephrine was not completely successful. In that case it might be very important that the positioning of the patient is precise and accurate so that paramedics can find the patient. Therefore a GPS-function should preferably be used, maybe also together with a WIFI or network positioning function in order to derive positioning information from both. The GPS-function should preferably be transmitting continuously until the medicament delivery device is switched off or the battery is depleted. This is because the emergency use of the medicament delivery device may take place on a moving vehicle, whereby the position of the patient is changing. In order for the paramedics to then find the patient, they need to receive the position continuously.

The signalling from the emergency device may further result in an automatic emergency call to a health care call centre. The patient may then talk directly to a physician or a nurse via a microphone <NUM>, wherein they can acquire the state of the patient. The call may be performed by the medicament delivery device, if provided with such functionality and with loudspeaker and microphone.

The positioning functionality may either be arranged in the medicament delivery device directly or may be incorporated in a smart device that can communicate with the medicament delivery device. However, when the positioning functionality is used for an emergency device, then it might be more advantageous that the positioning function is comprised directly in the device, because otherwise the signalling is dependent on two devices. This is a disadvantage because the patient might not have the smart device with him, or the smart device is dead due to depleted batteries.

As an alternative, the medicament delivery device may in addition be used together with a smart device. The communication unit of the medicament delivery device may then be arranged with circuits that are capable of connecting with the smart device. Such a smart device may be any smart device capable of receiving and transmitting information. If such a device receives certain information from a medicament delivery device, it may communicate directly to the user. Again, the communication may be done visually, e.g. by text stored in the smart device. Also, the communication may be done audibly, e.g. by a recorded message stored in the smart device and played through loudspeakers of the smart device. In this respect, the smart device may be arranged with a computer program or application that is started when the smart device receives the information from the electronics module of the medicament delivery device.

In this respect, the smart device may be arranged with communication modules that are capable of communicating with wireless networks, such as Wifi-networks, mobile communication networks, etc. such that it may transmit and/or receive information after being activated by the electronics module of the medicament delivery device. For instance, instead of having a program or an application stored in the smart device, the smart device may connect to suitable sites on the internet, where the appropriate information may be presented to the user.

Even though the medicament delivery devices have been described in connection with a medicament container filled with a treatment drug, it is to be understood that the medicament container could be a so called dummy that does not contain any medicament and that can be used for tutorial purposes. It is further to be understood that the communication unit may be integrated in the medicament delivery device, but it may also be arranged as a separate unit that could be connectable to the medicament delivery device; an add-on.

Claim 1:
Medicament delivery device comprising a housing (<NUM>; <NUM>), which housing (<NUM>; <NUM>) is arranged to accommodate a medicament container (<NUM>; <NUM>),
- a drive mechanism (<NUM>; <NUM>) capable of, upon activation, act on said medicament container (<NUM>; <NUM>);
- a communication unit (<NUM>; <NUM>) associated with said housing (<NUM>; <NUM>);
- a switch (<NUM>; <NUM>) operably connectable to said drive mechanism (<NUM>; <NUM>) and connected to said communication unit (<NUM>; <NUM>) for activating said communication unit (<NUM>; <NUM>) when said switch (<NUM>; <NUM>) is operated;
- said switch (<NUM>; <NUM>) is operated by said drive mechanism (<NUM>; <NUM>) at the end of a dose delivery sequence;
- said drive mechanism comprising a switching element (<NUM>; <NUM>) arranged to be released at the end of the dose delivery sequence and to act on said switch;
- said drive mechanism (<NUM>, <NUM>; <NUM>) further comprising a force element (<NUM>; <NUM>), which force element (<NUM>; <NUM>) enables said switching element to act on said switch, wherein said force element (<NUM>; <NUM>) is a drive spring arranged to act on and move a plunger rod of said drive mechanism in a proximal direction, characterised in that said drive spring (<NUM>) is arranged to act on said switching element (<NUM>) such that the switching element is moved in a distal direction at the end of the dose delivery sequence.