MEDICAMENT DELIVERY DEVICE DESIGN EVALUATION APPARATUS

Abstract

A medicament delivery device design evaluation apparatus is presented having a plurality of electronic demonstration units, wherein each electronic demonstration unit comprises a set of electronics, the set of electronics comprising a data receiver and at least one of an indication unit and a data transmitter; wherein the plurality of electronic demonstration units are configured to provide an indication when at least one of the plurality of electronic demonstration units receives a control signal.

Claims

1-15. (canceled)

16. A medicament delivery device design evaluation apparatus comprising: a plurality of electronic demonstration units, where each electronic demonstration unit comprises a set of electronics that comprises a data receiver and at least one of an indication unit and a data transmitter, wherein the plurality of electronic demonstration units are configured to provide an indication when at least one of the plurality of electronic demonstration units receives a control signal (3).

17. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein the indication is one of a visual indication provided by the indication unit when the set of electronics comprises an indication unit, an audible indication provided by the indication unit when the set of electronics comprises an indication unit, a tactile indication provided by the indication unit when the set of electronics comprises an indication unit, and a message sent by the data transmitter when the set of electronics comprises a data transmitter; or any combination thereof.

18. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein the medicament delivery device design evaluation apparatus comprises a control device configured to send the control signal to at least one of the plurality of electronic demonstration units.

19. The medicament delivery device design evaluation apparatus of claim 18, wherein the control device comprises a user interface, a communication unit, a memory that stores a set of instructions for evaluating a design of a medicament delivery device, and one or more processors; wherein the one or more processors are configured to use the set of instructions to: receive a user input from the user interface; send the control signal based on the user input; and wherein the control signal is sent from the communication unit to the data receiver of at least one of the plurality of electronic demonstration units.

20. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein the set of electronics of at least one of the plurality of electronic demonstration units comprises a sensor.

21. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein each electronic demonstration unit comprises a housing; wherein the set of electronics of each electronic demonstration unit is arranged in or on the housing.

22. The medicament delivery device design evaluation apparatus as claimed in claim 21, wherein each electronic demonstration unit comprises a battery arranged in or on the housing.

23. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein the plurality of electronic demonstration units comprises a housing; and wherein all of the plurality of electronic demonstration units are arranged in or on the housing.

24. The medicament delivery device design evaluation apparatus as claimed in claim 21, wherein the plurality of electronic demonstration units are detachable from the housing.

25. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein each electronic demonstration unit comprises a processor.

26. The medicament delivery device design evaluation apparatus as claimed in claim 23 wherein some of the plurality of electronic demonstration units are arranged to connect with a processor.

27. The medicament delivery device design evaluation apparatus as claimed in claim 19, wherein the set of electronics of at least one of the plurality of electronic demonstration units comprises a sensor and where the user input comprises an event for being detected by the sensor; and wherein the at least one of an indication unit and a data transmitter in the electronic demonstration unit is configured to provide the indication in accordance with the user input when at least one of the plurality of electronic demonstration units receives the control signal (3) and the event has been detected.

28. The medicament delivery device design evaluation apparatus as claimed in claim 27; wherein the sensor is at least one of a vibration sensor, microphone, gyroscope, accelerometer, inertia sensor, proximity sensor, light sensor, temperature sensor, image sensor, capacitance sensor, impedance sensor and gesture sensor.

29. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein one of the plurality of electronic demonstration units comprises a data transmitter configured to send a secondary control signal after receiving the control signal (3), and the data receiver of each of the other electronic demonstration units is configured to receive the secondary control signal.

30. The medicament delivery device design evaluation apparatus as claimed in claim 16, wherein each indication unit is at least one of a display, a light generator, a speaker, a buzzer, a temperature conditioner, and a vibration generator.

31. A medicament delivery device design evaluation apparatus comprising: a plurality of electronic demonstration units, where each electronic demonstration unit comprises a set of electronics that comprises a data receiver and at least one of an indication unit and a data transmitter; and a control device comprising a processor and is configured to send a control signal to at least one of the plurality of electronic demonstration units, wherein each electronic demonstration unit comprises a housing and a battery arranged in or on the housing, wherein the plurality of electronic demonstration units are configured to provide an indication when at least one of the plurality of electronic demonstration units receives the control signal, and wherein the set of electronics of at least one of the plurality of electronic demonstration units comprises a sensor.

32. The medicament delivery device design evaluation apparatus of claim 31, wherein the control device further comprises a user interface, a communication unit, and a memory that stores a set of instructions for evaluating a design of a medicament delivery device, where the processor is configured to use the set of instructions to: receive a user input from the user interface; send the control signal based on the user input; and wherein the control signal s sent from the communication unit to the data receiver of at least one of the plurality of electronic demonstration units.

33. The medicament delivery device design evaluation apparatus as claimed in claim 31, wherein the sensor is at least one of a vibration sensor, microphone, gyroscope, accelerometer, inertia sensor, proximity sensor, light sensor, temperature sensor, image sensor, capacitance sensor, impedance sensor and gesture sensor.

34. The medicament delivery device design evaluation apparatus as claimed in claim 32, wherein one of the plurality of electronic demonstration units comprises a data transmitter configured to send a secondary control signal after receiving the control signal, and the data receiver of each of the other electronic demonstration units is configured to receive the secondary control signal.

35. The medicament delivery device design evaluation apparatus as claimed in claim 34, wherein each indication unit is at least one of a display, a light generator, a speaker, a buzzer, a temperature conditioner, and a vibration generator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Embodiments of the present concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0037] FIG. 1 schematically shows an example of a medicament delivery device design evaluation apparatus comprising a plurality of electronic demonstration units.

[0038] FIG. 2A schematically shows a perspective view of an electronic demonstration unit of the medicament delivery device design evaluation apparatus of FIG. 1.

[0039] FIG. 2B schematically shows a perspective view of an electronic demonstration unit of a medicament delivery device design evaluation apparatus in another embodiment.

[0040] FIG. 3A schematically shows a perspective view of the medicament delivery device design evaluation apparatus of FIG. 1.

[0041] FIG. 3B schematically shows a perspective view of a medicament delivery device design evaluation apparatus comprising a plurality of electronic demonstration units in another embodiment.

[0042] FIG. 4 schematically shows a computer-implemented application for controlling the medicament delivery device design evaluation apparatus in a control device.

[0043] FIGS. 5A-5B shows a flow chart illustrating an embodiment of the present disclosure.

[0044] FIGS. 6A-6B schematically shows the medicament delivery device design evaluation apparatus of FIG. 1, comprising a plurality of electronic demonstration units.

[0045] FIG. 7 schematically shows a medicament delivery device design evaluation apparatus comprising a plurality of electronic demonstration units in another embodiment.

[0046] FIG. 8 schematically shows a scenario of the medicament delivery device design evaluation apparatus of FIG. 7.

DETAILED DESCRIPTION

[0047] A medicament delivery device design evaluation apparatus comprises a plurality of electronic demonstration units. Each electronic demonstration unit comprises a set of electronics, the set of electronics comprising a data receiver and at least one of an indication unit and a data transmitter. The plurality of electronic demonstration units, as illustrated as cubes in FIG. 1, is configured to provide an indication to a user when a control signal 3 has been received by the data receiver of at least one of the plurality of electronic demonstration units. The medicament delivery device design evaluation apparatus comprises a control device 2 for sending the control signal 3 to the medicament delivery device design evaluation apparatus 1. The control device 2 can be for example a smart phone, a computer or a pad computer. The control device 2 comprises a communication unit, a memory configured to store a set of instructions for evaluating a design of a medicament delivery device, and one or more processors. The communication unit of the control device 2 and the data receiver and transmitter of the plurality of electronic demonstration units may be based on a wireless communication technology, e.g. GPRS, 3G, 4G, 5G, WiFi, Low Power Wide Area (LPWA), Bluetooth, Zigbee, RFID, or NFC, but it can also be based on a wired communication technology for data transmission.

[0048] Also, the set of electronics of at least one of the plurality of electronic demonstration units can comprise a sensor. The sensor can be at least one of a vibration sensor, microphone, gyroscope, accelerometer, inertia sensor, proximity sensor, ultrasonic sensor, light sensor, temperature sensor, image sensor, capacitance sensor, impedance sensor and gesture sensor. The sensor is configured to detect an event related to handling of medicament delivery devices, such as a start or end of a medicament delivery sequence, a skin contact, an ambient temperature (if the medicament should be stored in certain temperature, the user may want to arrange a high temperature alarm), a shaking of the medicament delivery device and a illumination of environment (if the medicament is sensitive to the light, the user may want to arrange an exposure alarm).

[0049] The control device 2 is configured to send the control signal 3 to at least one of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus, so that the medicament delivery device design evaluation apparatus 1 will provide an indication via at least one of the plurality of electronic demonstration units. Such an indication can be one of a visual indication, an audible indication and a tactile indication demonstrated by the indication unit or a signal sent by the data transmitter or any combination thereof presented together or sequentially.

[0050] Each one of the electronic demonstration units typically has a printed circuit board (PCB), with the set of electronics including the data receiver and the at least one of an indication unit and a data transmitter, and also the sensor (if any) arranged on the PCB. The medicament delivery device design evaluation apparatus may comprise one or more housings. The plurality of electronic demonstration units may be arranged within the one or more housings.

[0051] In a preferred embodiment, each one of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1 has its own housing 10; 10′; 10″; 10‴, as shown in FIGS. 2A, 2B and 3A. The housings for each one of the electronic demonstration units are independent units relative to each other, as shown in FIG. 3A. The electronic demonstration units can be respectively arranged within each of the housings, each of the housings may comprise a sealable opening, e.g. sealed by a lid.

[0052] FIGS. 2A-2B illustrate example demonstration units of the plurality of electronic demonstration units, with each demonstration unit having one or more indication units; as an example, a demonstration unit comprises a housing 10, 10′, 10″, 10‴; one or more indication units 11a, 11b; 11a′, 11b′; 11″; 11‴; a data transmitter 12; a processor 13 and a battery 14. The indication units on one electronic demonstration unit can be different types of indication unit, for example, LED array and E-Ink display; or LED array and buzzer.

[0053] Alternatively, some of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1′ can be arranged within one housing, and some others of the plurality of electronic demonstration units can be arranged within another housing. For example, as shown in FIG. 3B, the plurality of electronic demonstration units comprises a first housing 10a′ and a second housing 10b′. A first group of the electronic demonstration units comprises some electronic demonstration units 1′a, 1′b, 1′c, arranged within the first housing 10a′. Two of the electronic demonstration units 1′a, 1b′ in the first group respectively comprise an indication unit, e.g. a LED; another electronic demonstration unit 1′c comprises an indication unit, e.g. a buzzer, and a sensor, e.g. a fingerprint sensor.

[0054] A second group of the electronic demonstration units comprises the electronic demonstration units 1′d and 1′e, arranged within the second housing 10b′. One of the electronic demonstration units 1′d comprises an indication unit; the other one of the electronic demonstration units 1′e comprises a data transmitter, e.g. a Bluetooth unit, and a sensor, e.g. a microphone.

[0055] In this case, two different sequences and the combination of indications can be provided at the same time, so a parallel comparison can be therefore provided to the user.

[0056] In another example, the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1″ can only have one housing 10″, as shown in FIG. 7, so that all electronic demonstration units are arranged within the housing 10″.

[0057] The housings may be non-detachable or detachable in relation to the plurality of electronic demonstration units. The former may be easy to use for the user; the latter may be more flexible for the user, since the user is able to change the housing based on his/ her needs.

[0058] The housing may have a shape and color depending on different type of medicament delivery devices in the market. As shown in FIG. 2B, the housing 10′, 10″, 10‴ can be made with shapes of different types of medicament delivery device, such as on-body device 10′, handhold injector 10″ and inhalation device 10‴. For example, if the user wants to see a green, blinking LED light on an on-body device/ infusion pump device, the user may have a housing 10′ with a shape of an on-body device/ infusion pump device, and arrange an electronic demonstration unit with such indication unit into that housing 10′ .

[0059] The housings 10 can also be a cube, as shown in FIGS. 2A, 3A, which also allows up to six different indications, especially visual indications, to be independently presented on the six surfaces of the cube.

[0060] The housing can also be just simply printed, e.g. by a 3D printer, by the user based on his/her own demand about the shape of the housing.

[0061] Each indication unit can be at least one of a display, (e.g. LCD or E-Ink); a light generator, (e.g. LED; a speaker; a buzzer); a temperature conditioner, (e.g. Peltier conditioner); or a vibration generator.

[0062] In a preferred embodiment, each one of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1; 1′; 1″ is configured to present a different indication, such as a visual, audible, tactile indication; sending a SMS/ app message (e.g. to a remote server or a personal mobile phone) by the data transmitter as an indication to the user.

[0063] In a preferred example, each one of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1; 1′; 1″ is configured to present one type of indication or one combination of indication types. In this embodiment, it can prevent any confusion for the user, because each of the indications can be individually observed or have a parallel comparison with another indication.

[0064] Each one of the plurality of electronic demonstration units may have a processor, as shown in FIGS. 2A, 2B and 3A, especially if each one of the plurality of electronic demonstration units 1 is respectively arranged within a respective housing, or if some of the plurality of electronic demonstration units are detachably arranged within one or several housings. Alternatively, some of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1′ can share one processor, as shown in FIG. 3B; or all of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1″ can share one processor, as shown in FIG. 7, especially where those electronic demonstration units are non-detachable and arranged within one housing 10a′, 10b′; 10″.

[0065] As shown in FIGS. 2A, 2B and 3A, each one of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1 may have a battery, e.g. a single use battery or a rechargeable battery that can be charged wirelessly or by wire, especially if each one of the plurality of electronic demonstration units is respectively arranged within a respective housing. Alternatively, some or all of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1′; 1″ can share one battery, as shown in FIG. 3B or FIG. 7, especially electronic demonstration units that are non-detachable or detachably arranged in one or several housings.

[0066] The plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1; 1′; 1″ is configured to demonstrate the demonstrated indication when at least one of the plurality of electronic demonstration units receives the control signal 3.

[0067] For generating the control signal 3, the control device 2 should be installed with a computer-implemented application, the computer-implemented application is formed by a set of instructions. As shown in FIG. 4. the application 400 is designed with an input module 401; a data store 402; a determination module 403 and a communication module 404. The computer-implemented application may optionally have other functional modules, for example, at least one of a register module, image recognition module, voice recognition module, QR code interpretation module, bar code interpretation module, Optical Character Recognition (OCR) module and Augmented Reality (AR) module.

[0068] The input module 401 is configured to receive a user input via a user interface 202 of the control device 2. In a preferred embodiment, the input module 401 displays selections or use guidance on the user interface 202 based on the data in the data store 402. The data store 402 is configured to store data related to the design evaluation of a medicament delivery device. For example, connection data, (e.g. communication addresses of each single electronic demonstration unit of the plurality of electronic demonstration units); identification data, (e.g. identifiers of each single electronic demonstration unit of the plurality of electronic demonstration units); data about type or amount of indication units, type or amount of sensors of each single electronic demonstration unit of the plurality of electronic demonstration units; data about events can be detected by the plurality of electronic demonstration units; data about one or several different medicament delivery devices; and data about one or several different time periods. These time periods may depend on the features of different medicament delivery devices, such as data on injection time, data on priming time, data on inhalation time, data on waiting time (the short time period between two intakes of medicament by the same medicament delivery device). Those different time periods may be used to simulate some specific events of different medicament delivery devices together with the indication selection, for example, to simulate a medicament delivery progress indication and/ or an end of a medicament delivery indication. The data in the data store can be manually or automatically updated from a cloud server or manually input through the user interface of the control device 2.

[0069] The determination module 403 is configured to retrieve data from the data according to the user input from the input module 401, and the determination module 403 is configured to determine the control signal 3 based on the the user input from the input module 401 and the retrieved data. The communication module 404 is configured to receive connection data, e.g. a communication address of the at least one of the plurality of electronic demonstration units, and the control signal 3 from the determination module 403; the communication module 404 is then configured to send the control signal 3 to the at least one of the plurailty of electronic demonstration units.

[0070] In use, the computer-implemented application, as shown in FIGS. 5A-5B, will first detect whether at least one of the plurality of electronic demonstration units has appeared, e.g. showing up within a communication range. If there is an appearance of the electronic demonstration unit, then the next step is identifying whether the electronic demonstration unit has been registered, e.g. whether the identifier of the electronic demonstration unit has been stored. If yes, the input module may retrieve the data from the data store, according to the identifier, and display information, e.g. icons, selections, user guidance, on the user interface of the control device 2. If not, a registration process will be started. These steps can be done in the determination module or the optional register module.

[0071] The registration can be done by pairing or by using the control device 2 to scan the QR codes or bar codes on one or several housings that seal the plurality of electronic demonstration units, dependent on the communication technology used between the plurality of electronic demonstration units and the control device 2, so that the identifiers of each one of the plurality of electronic demonstration unit can be downloaded to or interpreted by the control device 2 and then sent to the data store.

[0072] When the user makes an input on the user interface of the control device 2, the determination module will retrieve data from the data store based on the user input and the identifier(s), the determination module determines the control signal 3 based on the user input and the retrieved data, the determination module then sends the connection data and the control signal 3 to the communication module for sending the control signal 3 to at least one of the plurality of electronic demonstration units according to the connection data.

[0073] The input module may generate a graphical user interface (GUI) when the control device 2 is arranged with a screen. The GUI may show several icons in accordance with the data about plurality of electronic demonstration units from the register module and the data from the data store. The user may be able to provide an input by, for example, clicking on one or some of those icons. The input may include a selection of the type of medicament delivery device; the type of the indication(s), e.g. visual indication, audible indication, tactile indication and/or sending a message as an indication; the appearance of the selected indication(s), e.g. the color of the light, volume of the sound, what kind of sound, magnitude of vibration; the event(s) to be indicated, e.g. medicament delivery progress indication, end of a medicament delivery indication; the type of sensor, e.g. gesture sensor or proximity sensor; and/or the event for being detected by the selected sensor, e.g. contact with user’s skin.

[0074] Alternatively, the input module may have a voice recognition sub-module. In this case, the user may provide input by verbally instructing the control device 2.

[0075] Further, in another example, the input module may also connect with an AR module, so that when the user provides input, a virtual medicament delivery device with the components selected by the user, e.g. the types of indication or the appearance of the selected indication, can be displayed by the AR module; the user is therefore able to have an idea about how his/her choice may look like in the environment.

[0076] FIGS. 6A-6B illustrate one example of using the medicament delivery device design evaluation apparatus 1. Each one of the plurality of electronic demonstration units in this example comprises a housing, a processor and a battery. A first electronic demonstration unit 1a comprises a temperature sensor and a data transmitter; a second electronic demonstration unit 1b comprises a buzzer; and a third electronic demonstration unit 1c comprises a LED light array.

[0077] The user may have an input on the user interface of the control device 2; such user input may be: a) detecting skin contact; b) using a temperature sensor to detect skin contact; c) providing a beep sound and a green light. The control signal 3 is sent to the first electronic demonstration unit 1a, so that when the first electronic demonstration unit 1a detects a predetermined temperature, e.g. determining by programming on the first electronic demonstration unit 1a; or data from the data store which is sent together with the control signal 3, the first electronic demonstration unit 1a sends a secondary control signal 100 to the second and third electronic demonstration units 1b, 1c to generate an audible and a visual indication, as shown in FIG. 6A. Also, the user may then want to remove the green light when the contact of skin has been detected but use that green light to indicate the end of medicament delivery sequence. The user may make a second input on the user interface of the control device 2, such second user input may be: a) detecting skin contact; b) using a temperature sensor to detect the skin contact; c) providing a beep sound; d) a medicament delivery time period (e.g. 10 second or depends on the different targeted medicaments); e) providing a green light.

[0078] As shown in FIG. 6B, a fourth electronic demonstration unit 1d comprises a data transmitter and a clock, e.g. an LCD display digitally showing a clock or a countdown, so that when the first electronic demonstration unit 1a detects a predetermined temperature, the first electronic demonstration unit 1a sends a secondary control signal 100 to the second and fourth electronic demonstration units 1b, 1d to generate an audible indication (the beep sound) and to start to count the medicament delivery time period. Once the time period has passed, the fourth electronic demonstration unit 1d sends a further control signal 101 to the third electronic demonstration unit 1c to generate a visual indication (the green light).

[0079] Another example of using the medicament delivery device design evaluation apparatus 1″ is shown in FIGS. 7-8. In this example, the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1″ are all arranged in or on a housing 10″. The housing 10″ in this example has the shape of a handhold injector. The plurality of electronic demonstration units may comprise first, second, third and fourth electronic demonstration units 1″a, 1″b, 1″c, 1″d.

[0080] The user may have an input on the user interface of the control device 2; such a use input may be a) providing a start visual indication; b) using a temperature sensor to detect skin contact; c) continuing to monitor skin contact; d) providing an end visual indication; e) providing an interrupt alarm (if the medicament delivery is interrupted); and f) sending a message to a remote start device 4 if the medicament delivery is interrupted.

[0081] As illustrated by FIG. 8, the second electronic demonstration unit 1″b receives the control signal 3 from the control device 2, then the second electronic demonstration unit 1″b provides a light indication as the start indication. The second electronic demonstration unit 1″b also sends a secondary control signal 100″ to the first and the fourth electronic demonstration units 1″a, 1″d.

[0082] The first electronic demonstration units 1″a start to count a medicament delivery time period and display a visual indication when the time period passes. The fourth electronic demonstration unit 1d″ starts to count a medicament delivery time period and detects a predetermined temperature (used to indicate skin contact); if the detection changes rapidly before the time period passes, the fourth electronic demonstration unit 1d″ sends a further control signal 101″ to the third electronic demonstration unit to generate a visual indication as the interrupt alarm; and the fourth electronic demonstration unit 1d″ also sends a message 102″ to the remote smart device 4.

[0083] It should be noted that, alternatively, the control signal 3 can be sent to multiple or even all electronic demonstration units of the plurality of electronic demonstration units of the medicament delivery device design evaluation apparatus 1; 1′; 1″.

[0084] The medicament delivery device design evaluation apparatus can be used to facilitate a discussion between different users, for example before making a prototype that is closer to the final product. Especially, the medicament delivery device design evaluation apparatus can be used to demonstrate the electronic function that is planned to be used in a medicament delivery device or an add-on device/ accessory device that is usually used with or attached to a medicament delivery device, e.g. a monitoring device, so that the user is able to observe the performance of the planned-to-be-used indication, not only shown on the medicament delivery device itself, but around the medicament delivery device (as an add-on).

[0085] The recently disclosed concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the recently disclosed concept, as defined by the appended claims.