ACTIVATION SYSTEM FOR A SUPPLEMENTAL DEVICE ATTACHED TO A MEDICAMENT DELIVERY DEVICE

Abstract

The present disclosure relates to an activation system for a supplemental device that is attached to an existing design of a medicament delivery device, where the removal of a protective cap or other covering from the medicament delivery device pulls a blocking element from between electrical contacts to close a circuit between a battery module and a power source, thus activating the battery module. The supplemental device can further have a transmitter for communicating information about the use of the medicament delivery device to an external device, such as a smart device. Memory storage elements can also be included having unique identification data. The present disclosure also relates to a medicament delivery device having attached the supplemental device.

Claims

1-15. (canceled)

16. A system for activating a supplemental device attached to a medicament delivery device comprising: a medicament delivery device comprising: a housing; a medicament container positioned within the housing; and a dose delivery outlet accessible through a terminal end of the housing, a removable cap attached to the housing such that the dose delivery outlet is prevented from being accessible unless the cap is fully removed from the medicament delivery device; the supplemental device comprising: a battery module attached to the housing or to the cap, where the battery module comprises: a battery; a contact pad; a switch operatively connected to the battery and the contact pad, where a part of the switch is directly connected to the cap when the battery module is attached to the housing or where a part of the switch is directly connected to the housing when the battery module is attached to the cap; and a communication module connectable to the battery module or included as part of the battery module, and configured to transmit data to an external device, where the data comprises the information directly related to the status of the switch, wherein the switch is initially in a first state where the communication module is prevented to receive power from the battery and where movement of the cap relative to the housing changes the switch to a second state where the battery provides power to the communication module.

17. The system of claim 16, wherein the switch is configured to be in the first state only once.

18. The system of claim 16, wherein the switch is prevented to transform from the second state back to the first state.

19. The system of claim 16, wherein the switch further comprises a strip of material operatively connected with the battery or contact pad and wherein removal of the strip of material from the battery module starts the data transmission by the communication module.

20. The system of claim 19, wherein the strip of material comprises insulating material such that the strip prevents electricity conduction.

21. The system of claim 20, wherein the part of the switch comprises the strip material and is connected to an outside or inside surface of the cap or of the housing.

22. The system of claim 16, wherein the switch further comprises a biasing component that exerts a force that biases the contact pad towards a contact surface operatively associated with the battery.

23. The system of claim 16, wherein the attachment of the battery module and of the communication module are permanent such that the housing and the battery module are disposable and are prevented to be separated from each other without destroying the housing or the modules.

24. The system of claim 16, wherein the battery module or the communication module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device.

25. The system of claim 16, wherein the system further comprises a sensor module connectable to any other module and wherein said sensor module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device.

26. The system of claim 25, wherein any of the modules is removable from the housing and is reusable.

27. The system according to claim 16, wherein the battery module or the communication module comprises a recorder configured to obtain and store data information about the medicament delivery device.

28. The system of claim 27, wherein the data transmission by the communication module starts when the recorder receives power from the battery.

29. The system of claim 16, wherein the system further comprises a logging module connectable to any other module or included as part of any other module, and wherein the logging module is configured to start tracking motion of the medicament delivery device when the cap is removed.

30. The system of claim 16, wherein the system further comprises a memory module connectable to any other module or included as part of any other module, and wherein the memory module is configured to store the data and the communication module is configured to transmit the data wirelessly to the external device.

31. A system comprising a supplemental device attached to a medicament delivery device, where the medicament delivery device comprises: a housing having a proximal end and a distal end; and a removable cap attached to the proximal end of the housing that prevents user access to an outlet of a medicament container when positioned within the housing unless the cap is fully removed from the medicament delivery device, and the supplemental device comprises: a battery module attached to the housing or to the cap, where the battery module comprises: a battery; a contact pad; a switch operatively connected to the battery and the contact pad, where a part of the switch is directly connected to the cap when the battery module is attached to the housing or where a part of the switch is directly connected to the housing when the battery module is attached to the cap; and a communication module connectable to the battery module or included as part of the battery module, and configured to transmit data to an external device, where the data comprises the information directly related to the status of the switch, wherein the switch is initially in a first state where the communication module is prevented to receive power from the battery and where movement of the cap relative to the housing changes the switch to a second state where the battery provides power to the communication module, and wherein the switch is prevented from transforming from the second state back to the first state.

32. The system of claim 31, wherein the switch further comprises a strip of material operatively connected with the switch such that removal of the cap from the housing causes movement of the strip of material which electrically connects the battery to the communication module.

33. The system of claim 32, wherein the strip of material comprises an insulating material that prevents electricity conduction between the contact pad and the battery.

34. The system of claim 32, wherein the part of the switch comprises the strip material and is connected to an outside or inside surface of the cap or of the housing.

35. The system of claim 32, wherein the switch further comprises a biasing component that exerts a force that biases the contact pad towards a contact surface operatively associated with the battery.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0049] In the following detailed description of the invention, reference will be made to the accompanying drawings, of which

[0050] FIG. 1 schematically illustrates a general circuit diagram according to the present disclosure, where the medicament delivery device is not shown for clarity;

[0051] FIG. 2 schematically illustrates another general circuit diagram that uses a normally closed switch according to the present disclosure, where the medicament delivery device again is not shown for clarity

[0052] FIG. 3 is a schematic representation of one possible embodiment of the present disclosure where the supplemental device is a single disposable unit that is attached to an injection device;

[0053] FIG. 4 illustrates the embodiment of FIG. 3, where the individual components of the supplemental device are visible;

[0054] FIG. 5 is a partial cross-section view of the embodiment of FIG. 3 where the blocking element has a tether that is in a folded or accordion configuration within the battery module;

[0055] FIG. 6 is a partial cross-section view of another embodiment where the blocking element has a tether that is in a wrapped configuration within the battery module;

[0056] FIG. 7 is a partial cross-section view of the embodiment of either FIG. 3 or FIG. 5 where the tether has been extended and the protective cap/needle cover is removed, but the blocking element is still connected to the battery module;

[0057] FIG. 8 is a schematic representation of another possible embodiment of the present disclosure where a portion of the supplemental device removable from a battery portion and is reusable;

[0058] FIG. 9 shows the supplemental device of the present disclosure incorporated into a label for attachment to a medicament delivery device; and

[0059] FIG. 10 displays a functional scenario according to the present disclosure where the supplemental device integrates with the user and external devices.

DETAILED DESCRIPTION

[0060] 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.

[0061] 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. 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 medicaments in specific forms.

[0062] Turning first to FIG. 1, there is schematically shown the basic circuit diagram of the supplemental device that can be used in the present activation system. An energy source 2, shown as a coin battery, is electrically connected to a battery module. This battery module may contain, one or more sensors/sensor module as described above, a communication module for transmitting data to an external device, a recorder or memory module, and a controller (control unit). The sensors may include, a magnetometer, a gyroscope, and/or an accelerometer. A magnetometer may be used to detect the position of an auto injector needle of the medicament delivery device having attached the supplemental device. A gyroscope may be used to detect the position of the medicament delivery device and the accelerometer may be used to detect movement in a particular direction. By use of a combination of a gyroscope and three accelerometers, a high precision tracking may be provided. The supplemental device of FIG. 1 also contains an energy isolation feature comprising a switch mechanism that includes a biasing element 3, a contact pad 7 and a blocking element 4, for example, an insulating sheet. FIG. 2 illustrates another possible switch mechanism that uses a normally closed mechanical switch 3a that is mechanically held open until the cap is removed which then causes the switch to close and completes the circuit. A proximal end of blocking element 4 may contain an attachment feature 5 for direct connection to the cap or covering of a medicament delivery device, for example the injection device illustrated in FIGS. 3 and 4. Although the supplemental device 10 is shown attached to a proximal end of the outer housing 24 of the medicament delivery device, the supplemental device can be attached anywhere along the length of the outer housing 24.

[0063] The memory module, when present, can be a non-volatile memory to store data from the sensor(s)/sensor module and/or from a logging module. The non-volatile memory may e.g. be a read-only memory, flash memory, ferroelectric RAM (F-RAM), most types of magnetic computer storage devices (e.g. hard disks, floppy disks, and magnetic tape), optical discs. The non-volatile memory may be removable, to be inserted into a reader of an external device. The supplemental device may further be provided with a contact interface, allowing stored data to be uploaded to an external device through a cable connection. The communication module when present allows real data and/or stored data to be uploaded to the external device. The communication module is configured to wirelessly and/or wired transmit real time data from the logging module or to transmit stored data from the memory module. The communication module may be provided with e.g. wi-fi, Bluetooth or BLE.

[0064] As illustrated in FIG. 1, the blocking element, herein after referred to as just one example, that being an insulating sheet 4, is positioned between contact pads 7 such that no electricity flows from one contact to the other, i.e., an open circuit exists and the energy source is prevented to/cannot activate or energize the battery module. The biasing elements 3 act to keep the insulating sheet 4 in place between the contacts by exerting a compression force that biases the contacts towards each other. Removal of the insulating sheet 4 will result in the contact coming to tighter and closing the circuit, thus allowing the energy source to provide power to the battery module. In some instances, such as shown in FIG. 4, one of the contacts is a portion of the battery itself and depending on the design only a single biasing element is needed.

[0065] Referring to FIGS. 3-6 represents a possible configuration 30 where the battery module is attached to the outer housing 24 of a medicament delivery device 20 having a protective cap 21 and containing a medicament container 65 having a dose delivery outlet 60 i.e. a fixed needle that is covered by needle shield 62. Attached to protective cap 21 is needle shield remover 61, where the removal of the cap 21 from housing 24 necessarily causes removal of the needle shield 62 from needle. Attached to the cap 21 is part of the blocking element made up of tether 4 which can be comprised of an insulating material such that a portion of the tether is located between the biasing element 3 and battery 2.

[0066] In some instances, it is desirable that the protective cap be removed first from the device housing before the tether 4 is removed from the electrical circuit. This allows the user removing the cap to first overcome the securing forces holding the protective cap in place before having to also overcome the holding forces that hold the tether in place. As such, the length of the tether can be designed and configured so that the protective cap is fully removed from the device, i.e., reducing the cap holding force to zero, before the user applies a counter force to the tether that will eventual overcome the holding force on the tether that is a result of the electronic switch component of the battery module. Accordingly, the length of the tether can be predetermined and configured to 1) achieve a desired timing of battery activation and/or 2) to control the removal forces experienced by a user as the cap and tether are both removed from the medicament delivery device and battery module, respectively.

[0067] As shown in FIGS. 4 and 5, when it is desired to have a predetermined length of the tether 4 so that the protective cap can be removed first, the excess length of the tether needed represents a portion of the tether that can be stored inside the battery module in a folded or accordion configuration 4a. Alternative, as illustrated in FIG. 6 the tether could be stored in a wrapped configuration 4b. FIG. 7 shows the situation where the tether is designed with a length such that when in an extended configuration 4c the protective cap 21, needle shield remover 61, and needle shield 62 have been completely removed from needle hub 63, yet the blocking element 4d is still in place isolating the battery from the circuit. Further movement of cap 21 away from housing 24 will cause the blocking element to be removed from the battery module, thus closing the electrical circuit and allowing the battery to energize the battery module.

[0068] FIG. 4 also shows an embodiment where the battery module includes a number of electrical components such as a communication module 1b, a recorder 1d having data storage, and a processor or control unit 1c. All of these components/modules are in electrical communication through circuit board 1e and enclosed by cover 1a.

[0069] The communication module 1b of the battery module contained in the supplemental device of the present invention may also make use of radio frequency identification technology, RFID. In particular, high frequency RFID provides a number of advantages regarding communication. The possibilities of using HF RFID are numerous and in particular provides the use of Near Field Communication, NFC. NFC is particularly suitable because it is a set of standards for smartphones and the like smart devices to establish radio communication. NFC is a set of short-range wireless technologies, typically requiring a distance of 10 cm or less. NFC operates at 13.56 MHz on ISO/IEC 18000-3 air interface and at rates ranging from 106 kbit/s to 424 kbit/s. NFC always involves an initiator and a target; the initiator actively generates an RF field that can power a passive target. This enables NFC targets to take very simple form factors such as tags, stickers, key fobs, or cards that do not require batteries.

[0070] In the following description of the technology used the word NFC-tag may be used. In this context it is to be understood that NFC-tag will comprise an NFC-chip connected to a circuit as well as an antenna. NFC-tag is not limited to be integrated in a patch or label, but may be a stand-alone unit, or integrated in the material used for manufacturing medicament delivery devices. Further, the NFC-tag may include further features and components that are needed for the required or desired purposes and applications as will be apparent below.

[0071] NFC tags contain data and are typically read-only but may be rewriteable. They can be custom-encoded by their manufacturers or use the specifications provided by the NFC Forum, an industry association charged with promoting the technology and setting key standards. The tags can securely store personal data such as debit and credit card information, loyalty program data, PINs and networking contacts, among other information.

[0072] Regarding medicament delivery devices, they can be arranged with NFC tags in order to perform a number of tasks. The NFC tags may be arranged as part of the above-mentioned supplemental devices of the present invention and conveniently incorporated in labels which are attached to an outer surface of a housing of a medicament delivery device.

[0073] The types of short-range wireless technology (SRWT) that may be utilized in the supplemental devices include ANT+, RFID, Zigbee and Bluetooth. One favourable technology is then the Bluetooth-technology. Bluetooth technology operates in the unlicensed industrial, scientific and medical (ISM) band at 2.4 to 2.485 GHz, using a spread spectrum, frequency hopping, full-duplex signal at a nominal rate of 1600 hops/sec. The 2.4 GHz ISM band is available and unlicensed in most countries. Especially the Bluetooth low energy or Bluetooth Smart may be utilized in connection with medicament delivery devices and the functions that are requested. The Bluetooth circuit is provided with a transmitter that is capable of transmitting for instance a unique identification number or data as well as recording a time stamp. The Bluetooth circuit is preferably driven by the power source described above, e.g. the coin battery, wherein removal of the insulating strip acts a switch that is arranged between the battery and the Bluetooth circuit for activating the Bluetooth circuit only when there is an occurrence or change of status of the medicament delivery device.

[0074] FIG. 8 illustrates schematically one possible system 30 of the present disclosure where a medicament delivery device 20 has attached a supplemental device 10. The supplemental device 10 is attached via an adhesive to the outer surface of the proximal portion 23 of the medicament delivery device housing 24. The supplemental device 10 comprises a battery module, a battery compartment 6, an optional biasing member 3, a contact pad 7 that is insulated from battery 2 by a distal or free end of insulating sheet 4. Insulting sheet 4 is secured, for example, through an adhesive at the proximal end 5 to the protective cap 21 of the medicament delivery device 20. Importantly, insulating sheet 4 spans the connection point 22 where the cap 21 attaches to the proximal end 23 of device 20. The protective cap 21 covers the dose delivery outlet 60, e.g., an injection needle accessible only through the terminal proximal end of housing 24.

[0075] Removal of cap 21 from housing 24 will carry insulating strip 4 with the cap and thus remove it from between the battery 2 and contact pad 7. This will then close the circuit allowing the battery to activate and energize the battery module.

[0076] In another possible embodiment of the presently disclosed activation system (see FIG. 3), the design of the supplemental device is such that the battery module can be removed from the battery housing 6′ and reused. The battery module maybe releasable attached to the battery housing 6′ through connector 8, which might be a threaded connection, a snap fit connection, a weak adhesive connection or other releasable attachment feature.

[0077] FIG. 9 presents yet another embodiment of the activation system of the present disclosure where the activation system is part of or incorporated into a label 50 designed to be affixed to the outer housing of a medicament delivery device, such as housing 24 of medicament delivery device 20. The label 50 can include a separate RFID tag and antenna combination 9 in addition to the battery module. An insulting sheet in the form a strip or tether 4 is imbedded in in a proximal end portion of the label 50 whereby battery 2 is electrically isolated from the circuit connecting battery module with the RFID tag and antenna combination 9. This electrical circuit element is designed in the label and a portion of the proximal end is positioned on the medicament delivery device such that it extends over a tear line 51 that generally follows the interface between a cap or other covering of the medicament delivery device that completely covers the dose delivery outlet of the medicament delivery device, e.g., the protective cap 21 and the housing 23. When the medicament delivery device is to be used, the protective cap is removed, which will cause the label 50 to be torn along the tear line 51, which in turn will cause the insulating tether 4 to also be removed and thus pulling the tether away from the label that remains affixed to the housing. This pulling away of the tether closes the circuit such that the battery can now provide power to the circuit.

[0078] FIG. 10 illustrates one possible logical flow diagram representative of activation system of the present disclosure. Circuits may be connected to a number of modules or components within the supplemental device for providing status information. Such status information may comprise end of dose delivery. It may for example be important for a user to know when an injection sequence has ended and that it is safe to remove the device from the injection site. In this case a circuit may be affected by moving components at the end of dose delivery, wherein the circuit acts as a switch. The switch information detected by the SRWT is transmitted to the smart device, wherein the smart device is arranged to indicate to the user that the device may safely be removed. Also, this information confirms that the device is used.

[0079] The circuits and switches may further be used as interactive, step by step, instructions. For example, the smart device may be provided with an instruction application showing a user in a step-wise manner how a device should be handled. When one step has been performed, whereby a certain circuit has been affected and detected by the SRWT and transmitted to the smart device, an OK or positive response is provided by the smart device and displayed to the user. The instruction application then shows the subsequent handling step to be taken. In this manner, all steps affect different circuits that in turn provide the SRWT-chip with status information. This status information is successively transmitted to the smart device and appropriate information is displayed to the user by the instruction application.

[0080] In connection with the increased integration of the medicament delivery device and the smart device through the use of the supplemental device (see FIG. 6), further information could be collected in order to increase the understanding of the effects of a certain treatment scheme, e.g. disease monitoring. The programs or applications that are used in the smart device in connection with the medicament delivery devices may further include questionnaires that are filled in by the user in connection with a dose delivery operation. The questionnaire may include a number of questions regarding the current status of the patient and may preferably be configurable depending on therapy, disease and user needs. The areas that might be handled may include quality of life, cognitive function, pain, fatigue, nausea, mental health, etc. The answers of the questionnaire may then be transmitted from the smart device to external databases together with information collected via the SWRT-tags for processing and evaluation to find positive or negative correlations between the treatment scheme and type of medicament in relation to the perceived condition of the patient.

[0081] Further, if the smart device is not equipped with an NFC-reader, the attachment could be provided with such an NFC-reader, thereby adding functionality to the smart device. The integration of the medicament delivery device and the smart device further provides real time interactive user instructions as well as correct injection times, dates and dose quantities because of the close connection between the medicament delivery device and the smart device because of real time reading of the NFC-tag. The injection times, dates and dose quantities can be recorded directly in the smart device for further processing or transmittal.

[0082] Many smart devices are arranged with motion sensors in three dimensions, which functionality could be used in connection with handling of the medicament delivery device. For instance, the smart device could detect how it, and thus the medicament delivery device, is being held. This may be important for some types of medicaments and for some types of medicament delivery devices in that the medicament delivery device has to be held in a certain way during some steps when used. This could for example be a medicament delivery device using a so-called dual chamber medicament container, where it can be important how the medicament container is held during mixing and priming. The motion sensors of the smart device could then be used to detect how the medicament delivery device is held and could inform a user on how to hold the device and alert the user if the device is not held according to instructions.

[0083] Further features of the smart device that could be used with the integrated medicament delivery device include the use of a camera that is often an integrated part of the smart device. The camera could then be used to take photographs of the content of the medicament container, which often is transparent, in order to obtain information regarding the status of the medicament. For example, colouring or opacity of a medicament may indicate that something adverse has happened to the medicament, such as exposure to temperatures outside the prescribed range, such that the medicament should not be used. The comparison of colour or opacity may be performed directly by the user in an application in the smart device, or the picture may be sent by the smart device to an external site where skilled personnel perform the comparison and alert the patient of any deficiencies of the medicament and advice as to how proceed.

[0084] Regarding adherence and patient responsibility, there are features and functions of the smart device that may be utilized. Some medicaments and treatment schemes are very expensive to the national healthcare authorities and a lot of responsibility is put on the users to really adhere to the treatment schemes. There has been discussions in several countries in the world that if patients do not adhere to an expensive treatment, they should be forced to pay for the continued treatment, fully or partly, the arguments being that those persons that are not interested enough in a treatment should have to pay for it. The information and medicament delivery history obtained from the NFC-tags could be used to monitor the adherence.

[0085] In that respect, biometrical sensors such as fingerprint sensors, eye and/or face recognition via cameras on the smart devices mat provide proof of a user of a certain medicament delivery device, providing proof that it is the legitimate user that has activated the medicament delivery device for delivering a dose. Biometrical sensors may further be used in order to ascertain that the device is prevented to/cannot be accidentally, or wilfully, used by a third person.

[0086] For example, if a larger battery is used, the NFC-tag could use the temperature sensor that is built into the NFC-chip. This may be an advantage because then the temperature of a medicament delivery device and/or a medicament container may be monitored and logged for instance during transport. This might be important for a number of medicaments that are temperature sensitive, whereby it can be ensured that the quality of the medicament has not been affected by temperature variations outside approved ranges. Also, the temperature sensor could be used to provide information when a medicament has reached a target temperature for delivery. The information is then communicated to the smart device, where the latter provides handling and temperature information to the user.

[0087] 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 invention and that it may be modified in many ways within the scope of the patent protection.