An electronic assembly of a medicament delivery device

Abstract

An electronic assembly of a medicament delivery device, wherein the medicament delivery device comprises a housing extending along a longitudinal axis between a proximal end and a distal end and a cap attached to the proximal end of the housing, the electronic assembly comprising: an electronic unit; and an activator; wherein one of the electronic unit and the activator is attached to the cap of a medicament delivery device and the other one of the electronic unit and the activator is attached to the housing of a medicament delivery device; wherein the electronic unit is inactive when the activator is engaged with the electronic unit, and is configured to be activated when the activator is spaced apart from the electronic unit; wherein the activator is axially movable in a direction of the longitudinal axis relative to the electronic unit from a first position where the activator is engaged the electronic unit to the second position where the activator is spaced apart from the electronic unit; and wherein the activator is rotatable along with the electronic unit around the longitudinal axis when the activator is in the first position.

Description

[0001] AN ELECTRONIC ASSEMBLY OF A MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to an electronic assembly of a medicament delivery device and particularly concerns the electronic assembly comprising an electronic unit and an activator.

[0004] BACKGROUND

[0005] A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on- body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations still exist in the current technology. Not least among these are the difficulties faced by patients who require frequent injections and by patients who need to inject particularly viscous drugs. In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, for example concerning manual operation of the outer cap of the medicament delivery devices, which are set out in more detail below.

[0006] SUMMARY

[0007] An object of the present disclosure is to provide a subassembly of a medicament delivery device, and a medicament delivery device which solves, or at least mitigates problems of the prior art.

[0008] There is provided an electronic assembly of a medicament delivery device, wherein the medicament delivery device comprises a housing extending along a longitudinal axis between a proximal end and a distal end and a cap releasably attached to the proximal end of the housing, the electronic assembly comprising: an electronic unit; and an activator. One of the electronic unit and the activator is attached to the cap of a medicament delivery device and the other one of the electronic unit and the activator is attached to the housing of a medicament delivery device. The electronic unit is inactive when the activator is engaged with the electronic unit and is configured to be activated when the activator is spaced apart from the electronic unit. The activator is axially movable in a direction of the longitudinal axis relative to the electronic unit from a first position where the activator is engaged with the electronic unit to the second position where the activator is spaced apart from the electronic unit. The activator is rotatable along with the electronic unit around the longitudinal axis when the activator is in the first position.

[0009] Embodiments of the present disclosure advantageously provide for activation of the activation member when the outer cap is moved relative to the proximal housing part. In this way, the communication module may transmit device status data to an external device informing the latter of that a patient is using the medicament delivery device.

[0010] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the components thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site.

[0011] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0012] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0013] Further, the terms “circumference”, “circumferential”, “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a longitudinal axis extending in the direction of the longest extension of the device and / or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis. According to one embodiment, the electronic assembly comprises an activator holder configured to be operably attached to either the housing or the cap.

[0014] According to one embodiment, the activator holder is configured to be rotated around the longitudinal axis.

[0015] According to one embodiment, the activator is rotatably fixed to the activator holder such that the activator is immovable relative to the activator holder in a circumferential direction around the longitudinal axis.

[0016] According to one embodiment, the activator holder comprises a ball bearing configured to be directly attached to either the housing or the cap.

[0017] According to one embodiment, the electronic assembly comprises a track engaged with the activator holder such that the activator holder is configured to be indirectly attached to either the housing or the cap via the track.

[0018] According to one embodiment, the activator holder is movable relative to the track in the circumferential direction around the longitudinal axis and is immovable relative to the track in the direction of the longitudinal axis.

[0019] According to one embodiment, the track is configured to be attached to either the housing or the cap.

[0020] According to one embodiment, the track comprises a ring and the activator holder is attached to the ring and movable along the ring.

[0021] According to one embodiment, the track comprises an annular groove in which the activator holder is received.

[0022] According to one embodiment, the activator holder is configured to be operably attached to the housing.

[0023] According to one embodiment, the track is configured to be attached to the housing.

[0024] According to one embodiment, the electronic unit is configured to be attached to the cap. According to one embodiment, the activator comprises an insulator positioned between two conductive surfaces of the electronic unit when the activator is in the first position.

[0025] According to one embodiment, the insulator is an insulating strip.

[0026] According to one embodiment, the insulator is positioned between a circuit of the electronic unit and a battery of the electronic unit.

[0027] According to one embodiment, the activator comprises a protruding pin configured to press on a switch of the electronic unit when the activator is in the first position.

[0028] According to one embodiment, the electronic unit comprises a communication unit.

[0029] According to one embodiment, the communication unit is configured to wirelessly send out, e.g., broadcast, and / or receive a signal when the circuit is connected to the battery.

[0030] According to one embodiment, the communication unit can be a short-range communication unit, such as RFID, NFC, infra-red, ZigBee, Bluetooth, and / or a long- range communication unit, such as 3G, 4G, CAT-M1 , NB-loT, LoRa, Sigfox, 5G, or GPRS.

[0031] According to one embodiment, the electronic unit comprises a processor, e.g., and / or a micro control unit (MCU), and / or a memory, and / or a clock, and / or an indicator and / or a sensor.

[0032] According to one embodiment, the memory can be a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM) or a Flash memory, such as a compact Flash memory.

[0033] According to one embodiment, the indicator can be an acoustic indicator, such as a speaker or a buzzer. For example, the indicator can be a visual indicator, such as an e-ink display, an LCD display or an LED light emitter and / or the indicator can be a haptic indicator, such as a vibrator.

[0034] According to one embodiment, the sensor can be an orientation sensor, such as an accelerometer or a gyroscope, and / or the sensor can be an environmental condition sensor, such as a temperature sensor, light sensor, vibration sensor or contact sensor.

[0035] According to one embodiment, the battery is a coin-sized battery, a thin film battery, and / or a fuel cell battery, e.g., an enzymatic paper-based fuel cell.

[0036] According to one embodiment, when the electronic unit is activated, the communication unit is configured to send out a signal.

[0037] According to one embodiment, when the electronic unit is activated, the indicator is configured to provide an indication to a user of the medicament delivery device.

[0038] According to one embodiment, when the electronic unit is activated, the sensor is configured to sense an event.

[0039] Another aspect of the invention provides a sub-assembly of a medicament delivery device. The sub-assembly comprises the electronic assembly as mentioned in embodiments above; a housing extending along a longitudinal axis between a proximal end and a distal end; and a cap releasably attached to the proximal end of the housing.

[0040] According to one embodiment, the cap is configured to be removed from the housing by being rotated around the longitudinal axis followed by being axially moved in the proximal direction relative to the housing along the longitudinal axis.

[0041] According to one embodiment, the cap is operably attached to the housing via a thread or bayonet connection.

[0042] According to one embodiment, the activator is in the first position when the cap is rotated around the longitudinal axis and is in the second position when the cap is axially moved in the proximal direction relative to the housing along the longitudinal axis.

[0043] According to one embodiment, the medicament delivery device is a pen-type, handhold, portable device.

[0044] According to one embodiment, the medicament delivery device is an autoinjector, a pen injector, an inhalation device, or a medical sprayer. According to one embodiment, the medicament delivery device comprises a medicament container containing a medicament.

[0045] According to one embodiment, the medicament container is a syringe, a cartridge or a collapsible bag.

[0046] According to one embodiment, the medicament delivery device comprises a medicament delivery member configured to be fluidly connected to the medicament container during the use of the medicament delivery device.

[0047] According to one embodiment, the medicament delivery member is an injection needle, a soft cannula, or a spray nozzle.

[0048] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a / an / the member, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the member, apparatus, component, means, etc., unless explicitly stated otherwise.

[0049] BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0051] Fig. 1 is a perspective view of an electronic assembly attached to a cap of a medicament delivery device and a housing of the medicament delivery device;

[0052] Fig. 2 is a perspective view of the electronic assembly of Fig. 1 when the cap is rotated relative to the housing;

[0053] Fig. 3 is a perspective view of the electronic assembly of Fig. 1 when the cap is axially moved away from the housing; and

[0054] Fig. 4 is a perspective view of the medicament delivery device comprising the cap and the housing.

[0055] DETAILED DESCRIPTION

[0056] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.

[0057] Figs 1-3 illustrate an electronic assembly of a medicament delivery device as shown in Fig. 4. The medicament delivery device comprises a housing 6 extending along a longitudinal axis L between a proximal end and a distal end and a cap 5 attached to the proximal end of the housing 6. The electronic assembly comprises an electronic unit 1 and an activator 2. One of the electronic unit 1 and the activator 2 is attached to the cap 5 of a medicament delivery device and the other one of the electronic unit 1 and the activator 2 is attached to the housing 6 of a medicament delivery device. The electronic unit 1 is inactive when the activator 2 is engaged with the electronic unit 1 and is configured to be activated when the activator 2 is spaced apart from the electronic unit 1. When the electronic unit is inactive, the electronic unit is configured to consume minimum energy or no energy consumption. As a result, no designed functions of the electronic unit can be performed. When the electronic unit is active, the electronic unit is configured to consume enough energy to perform the designed functions. The activator 2 is axially movable in a direction of the longitudinal axis L relative to the electronic unit 1 from a first position where the activator 2 is engaged with the electronic unit 1 to the second position where the activator 2 is spaced apart from the electronic unit 1. The activator 2 is rotatable along with the electronic unit 1 around the longitudinal axis L when the activator 2 is in the first position.

[0058] Additionally, in one example, the electronic unit comprises a communication unit connected to the circuit. The communication unit is configured to wirelessly send out, e.g. broadcast, and / or receive a signal.

[0059] The communication unit can be a short-range communication unit, such as RFID, NFC, infra-red, ZigBee, Bluetooth, and / or a long-range communication unit, such as 3G, 4G, CAT-M1 , NB-loT, LoRa, Sigfox, 5G, or GPRS. Additionally, in one example, the electronic unit comprises a processor, e.g., a micro control unit (MCU), and / or a memory, and / or a clock, and / or an indicator and / or a sensor.

[0060] Additionally, in one example, the memory can be a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM) or a Flash memory, such as a compact Flash memory.

[0061] Additionally, in one example, the indicator can be an acoustic indicator, such as a speaker or a buzzer. For example, the indicator can be a visual indicator, such as an e-ink display, an LCD display or an LED light emitter and / or the indicator can be a haptic indicator, such as a vibrator.

[0062] Additionally, in one example, the sensor can be an orientation sensor, such as an accelerometer or a gyroscope, and / or the sensor can be an environmental condition sensor, such as a temperature sensor, light sensor, vibration sensor or contact sensor.

[0063] Additionally, in one example, the battery is a coin-sized battery, a thin film battery, and / or a fuel cell battery, e.g., an enzymatic paper-based fuel cell.

[0064] Additionally, in one example, when the electronic unit is activated, the communication unit is configured to send out a signal.

[0065] Additionally, in one example, when the electronic unit is activated, the indicator is configured to provide an indication to a user of the medicament delivery device.

[0066] Additionally, in one example, when the electronic unit is activated, the sensor is configured to sense an event.

[0067] As one of the electronic unit 1 and the activator 2 is attached to the housing 6 of the medicament delivery device and the other one of the electronic unit 1 and the activator 2 is attached to the cap 5 of the medicament delivery device, when the user of the medicament delivery device plans to use the medicament delivery device, the user removes the cap 5 from the housing 6. As a result, the activator 2 is moved into the second position relative to the electronic unit 1 , and the electronic unit 1 is thereby activated. As the cap 5 of a medicament delivery device is configured to keep a medicament container of the medicament delivery device and / or a medicament delivery member of the medicament delivery device sterilized, thus, the activation of the electronic unit 1 indicates the sterilization of the medicament delivery device is broken. The electronic unit 1 can now send out a signal and / or provide an indication to record and / or indicate the status change of the medicament delivery device.

[0068] In one example, the activator comprises a protruding pin configured to press on a switch of the electronic unit when the activator is in the first position. Alternatively, or additionally, the activator 2 comprises an insulator positioned between two conductive surfaces of the electronic unit 1 when the activator 2 is in the first position. Preferably, the insulator is positioned between the battery of the electronic unit 1 and a circuit of the electronic unit 1. In a preferred example, the insulator is an insulating strip. In this example, the battery of the electronic unit 1 can last longer.

[0069] In one example, the electronic assembly comprises an activator holder 4 configured to be operably attached to either the housing 6 or the cap 5. The activator holder 4 is configured to be rotated around the longitudinal axis L. The activator 2 is rotatably fixed to the activator holder 4 such that the activator 2 is immovable relative to the activator holder 4 in a circumferential direction R around the longitudinal axis L.

[0070] As a result, the activator 2 is can be rotated together with the electronic unit 1 around the longitudinal axis L (as shown with arrow R in Fig. 2).

[0071] In one example, the activator holder 4 comprises a ball bearing configured to be directly attached to either the housing 6 or the cap 5. Alternatively, or additionally, the electronic assembly comprises a track 3 engaged with activator holder 4 such that the activator holder 4 is configured to be indirectly attached to either the housing 6 or the cap 5 via the track 3. The activator holder 4 is movable relative to the track 3 in the circumferential direction R around the longitudinal axis L and is immovable relative to the track 3 in the direction of the longitudinal axis L. The track 3 is configured to be attached to either the housing 6 or the cap 5.

[0072] In one example, the track 3 comprises a ring. In this example, the activator holder 4 is attached to the ring and movable along the ring. Alternatively, the track 3 comprises an annular groove 30 received the activator holder 4. In one example as shown in Figs 1-3, the activator holder 4 is configured to be operably attached to the housing 6. In one example, the track 3 is configured to be attached to the housing 6. In this example, the electronic unit 1 is configured to be attached to the cap 5. As the housing 6 of the medicament delivery device is configured to receive a medicament container containing medicament, after the medicament delivery operation, the housing 6 of the medicament delivery device is usually considered to be medical waste and thus required to be disposed of in a specific way. On the other hand, the electronic unit 1 is required to be recycled or disposed of in a way of handling electronic waste, thus, in the example where the electronic unit 1 is configured to be attached to the cap 5, the process of disposing of a used medicament delivery device can be simplified and the cost of disposing of a used medicament delivery device can be reduced.

[0073] It should be noted that, alternatively, the electronic unit can be attached to the housing of the medicament delivery device and the activator, the activator holder and the track (in the example where the electronic assembly comprises the track) can be attached to the cap. In this example, the electronic unit can be used to detect multiple events during the medicament delivery operation, such as the start of the medicament delivery operation or the end of the medicament delivery operation. Furthermore, the electronic unit can provide indications to the user of the medicament delivery device regarding multiple events respectively.

[0074] Another aspect of the invention provides a sub-assembly of a medicament delivery device. The sub-assembly comprises the electronic assembly as mentioned in any above-mentioned example, a housing 6 extending along a longitudinal axis L between a proximal end and a distal end; and a cap 5 attached to the proximal end of the housing 6. In one example, the cap 5 is configured to be removed from the housing 6 by being rotated around the longitudinal axis L (as shown with the arrow R in Fig. 2) followed by being axially moved in the proximal direction relative to the housing 6 along the longitudinal axis L (as shown by arrow A in Fig. 3). For example, the cap 5 is operably attached to the housing 6 via a thread or bayonet connection. In this example, the activator 2 is in the first position when the cap 5 is rotated around the longitudinal axis L and is in the second position when the cap 5 is axially moved in the proximal direction relative to the housing 6 along the longitudinal axis 6. As the movement that causes the cap 5 to be spaced apart from the housing 6 is the axial movement of the cap 5 relative to the housing 6 rather than the rotation movement of the cap 5 relative to the housing 6, the electronic assembly as disclosed herein makes the detection of cap removal more precise. Furthermore, the electronic assembly can be more compatible with more medicament delivery devices. For example, the medicament delivery device might be designed to have the cap to be freely rotated relative to the housing for a certain angle before the cap starts travelling along a thread or bayonet connection to avoid any unintended cap removal, in this example, the electronic unit will stay inactive when the cap is unintentionally rotated (but not yet moved axially away from the housing).

[0075] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1 a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1 a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)). Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present. The inventive 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 inventive concept, as defined by the appended claims.

Claims

CLAIMS1. An electronic assembly of a medicament delivery device, wherein the medicament delivery device comprises a housing extending along a longitudinal axis between a proximal end pointing towards a dose delivery site during use of the medicament delivery device and a distal end being oppose to the proximal end, and a cap releasably attached to the proximal end of the housing; the electronic assembly comprising: an electronic unit; and an activator; wherein one of the electronic unit and the activator is attached to the cap of a medicament delivery device and the other one of the electronic unit and the activator is attached to the housing of a medicament delivery device; wherein the electronic unit is inactive when the activator is engaged with the electronic unit, and is configured to be activated when the activator is spaced apart from the electronic unit; wherein when the electronic unit is inactive, the electronic unit is configured to consume minimum energy or no energy consumption, therefore, no designed functions of the electronic unit can be performed; wherein when the electronic unit is active, the electronic unit is configured to consume enough energy to perform the designed functions; wherein the activator is axially movable in a direction of the longitudinal axis relative to the electronic unit from a first position where the activator is engaged with the electronic unit to a second position where the activator is spaced apart from the electronic unit; and wherein the activator is rotatable along with the electronic unit around the longitudinal axis when the activator is in the first position.

2. The electronic assembly according to claim 1 , wherein the electronic assembly comprises an activator holder configured to be operably attached to either the housing or the cap; wherein the activator holder is configured to be rotated around the longitudinal axis; and wherein the activator is rotatably fixed to the activator holder such that the activator is immovable relative the activator holder in a circumferential direction around the longitudinal axis.

3. The electronic assembly according to claim 2, wherein the activator holder comprises a ball bearing configured to be directly attached to either the housing or the cap.

4. The electronic assembly according to claim 2, wherein the electronic assembly comprises a track engaged with the activator holder such that the activator holder is configured to be indirectly attached to either the housing or the cap via the track; wherein the activator holder is movable relative to the track in the circumferential direction around the longitudinal axis and is immovable relative to the track in the direction of the longitudinal axis; and wherein the track is configured to be attached to either the housing or the cap.

5. The electronic assembly according to claim 4, wherein the track comprises a ring; wherein the activator holder is attached to the ring and movable along the ring; or the track comprises an annular groove in which the activator holder is received.

6. The electronic assembly according to any one of claims 2-5, wherein the activator holder is configured to be operably attached to the housing.

7. The electronic assembly according to claim 4 or 5, wherein the track is configured to be attached to the housing.

8. The electronic assembly according to claim 6 or 7, wherein the electronic unit is configured to be attached to the cap.

9. The electronic assembly according to any one of the preceding claims, wherein the activator comprises an insulator positioned between two conductive surfaces of the electronic unit when the activator is in the first position.

10. The electronic assembly according to claim 9, wherein the insulator is an insulating strip.

11. The electronic assembly according to any one of the preceding claims, wherein the activator comprises a protruding pin configured to press on a switch of the electronic unit when the activator is in the first position.

12. A sub-assembly of a medicament delivery device, the sub-assembly comprising: the electronic assembly according to any one of the preceding claims; a housing extending along a longitudinal axis between a proximal end and a distal end; and a cap releasably attached to the proximal end of the housing.

13. The sub-assembly according to any one of the preceding claims, wherein the cap is configured to be removed from the housing by being rotated around the longitudinal axis followed by being axially moved in the proximal direction relative to the housing along the longitudinal axis.

14. The sub-assembly according to claim 13, wherein the cap is operably attached to the housing via a thread or bayonet connection.

15. The sub-assembly according to claims 13 or 14, wherein the activator is in the first position when the cap is rotated around the longitudinal axis and is in the second position when the cap is axially moved in the proximal direction relative to the housing along the longitudinal axis.

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