A medicament delivery device is presented having a housing that is arranged to accommodate a medicament container, a drive mechanism capable of, upon activation, act on said medicament container, a communication unit arranged in the housing, a switch operably connectable to the drive mechanism and connected to the communication unit for activating the communication unit when the switch is operated, wherein the switch is operated by the drive mechanism at the end of a dose delivery sequence.
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1. A medicament delivery device comprising:
a housing, which housing is arranged to accommodate a medicament container,
a drive mechanism that engages the medicament container when the drive mechanism is activated, where the drive mechanism comprises an actuator having a cut-out located in a distal end wall, a switching element and a force element, where the force element directly engages an inside surface of a distal end of the switching element and where a conductive lead extends through the cut-out,
a communication unit operatively connected to the housing and electrically connected to the conductive lead, and
a switch comprising a contact surface on the lead that is located inside of the actuator and a conductive surface of the distal end of the switching element, where the switch is in an open position before and partially during activation of the drive mechanism and is in a closed position when the conductive surface of the distal end of the switching element moves axially and distally relative to the actuator coming into contact with the contact surface of the lead, where the communication unit is activated when the switch is closed.
15. A medicament delivery device comprising:
a housing;
a drive mechanism positioned with the housing, where the drive mechanism comprises a plunger rod driver, an actuator and an elongated plunger rod having a distally directed end surface, where the plunger rod driver moves axially in a proximal direction relative to the housing;
a switch having a closed position and an open position;
a communication unit operably connected to the housing and in electrical communication with the switch, where the switch activates the communication unit when the switch is in the closed position;
a switching element directly in contact with the distally directed end surface of the elongated plunger rod and having an electrically conductive surface, where the switching element is axially fixed to the plunger rod driver, moves in a proximal direction, and is released from the plunger rod driver when an end of dose delivery sequence is reached causing the switch to move axially in a proximal direction relative to both the housing and the switching element such that the switch moves from the open position to the closed position and the electrically conductive surface of the switching element contacts a corresponding conductive surface on the switch.
0. 18. A medicament delivery device comprising:
a housing comprising an open distal end, which housing is arranged to accommodate a medicament container,
a drive mechanism that engages the medicament container when the drive mechanism is activated, where the drive mechanism comprises an actuator having a tubular portion located in a distal end of the actuator, a U-shaped switching element slidably positioned within the tubular portion and a force element positioned between proximally extending elongated arms of the switching element, where the force element directly engages an inside surface of a distal end of the switching element,
a communication unit operatively positioned within the housing and electrically connected to a switch comprising:
a contact surface on one end of a conductive lead that extends through a cut-out in a distal end wall of the tubular portion; and
a contact element positioned on a flexible tongue that is electrically connected to the communication unit;
wherein the switch is in an open position before and partially during activation of the drive mechanism and the switch is in a closed position when the force element moves the distal end of the switching element axially and distally relative to the actuator such that the distal end of the switching element engages with and pushes the flexible tongue causing the contact surface to come into contact with the contact element, where the communication unit is activated when the switch is closed.
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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 154 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 256 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, 4G, 5G, 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 enable 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 expose 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 158, 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.
It is to be understood that the embodiments described above and shown in the drawings are to be regarded only as non-limiting examples of the disclosure and that it may be modified in many ways within the scope of the patent claims.
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