EP4661938A1

EP4661938A1 - A sub-assembly of a medicament delivery device

Info

Publication number: EP4661938A1
Application number: EP24702141.3A
Authority: EP
Inventors: Alexander STIEGLER; Chun-Hsien Huang; Lucas CARPENTER
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2023-02-08
Filing date: 2024-01-25
Publication date: 2025-12-17
Also published as: WO2024165329A1

Abstract

A sub-assembly of a medicament delivery device, the sub-assembly comprising: a housing extending between a proximal end and a distal end along a longitudinal axis; wherein the housing is configured to accommodate a medicament container of the medicament delivery device; wherein the housing comprises an activator extending from the housing in a direction transverse to the longitudinal axis; a sensor assembly comprises a shell and a set of electronics at least partially placed within the shell; wherein the set of electronics comprises a processor and a switch electrically connected to the processor; wherein the switch is movable between a non-activated state and an activated state; wherein the sensor assembly is removably attached to the housing; wherein the sensor assembly is movable relative to the housing in the direction of the longitudinal axis between a first position where the switch of the sensor assembly is spaced away from the activator of the housing and a second position where the switch of the sensor assembly is adjacent to the activator of the housing such that the switch is moved from the non-activated state to the activated state by the activator when the shell is in the second position; and wherein the shell comprises a proximal contact surface extending beyond the proximal end of the housing.

Description

TITLE

A sub-assembly of a medicament delivery device.

TECHNICAL FIELD

The present disclosure generally relates to a sub-assembly of a medicament delivery device, and particularly to a sub-assembly of a medicament delivery device comprising a sensor assembly.

BACKGROUND

Medicament delivery devices such as auto-injectors, inhalers, or on-body devices are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes or people who are undergoing an artificial fertilization procedure may require repeated injections of insulin or hormone. Other patients may require regular injections of other types of medicaments, such as a growth hormone.

As those medicament delivery devices are designed for patients without formal medical training and operation of those medicament delivery devices might be taking place in a patient's own house, which is usually not in a place of professional health/ medical care, e.g. hospital, clinic or health centres, there is a demand for automatically recording every single delivery operation that has been taken by the user. The record can help the user to track his/ her medicament intake or as the basis of an alarm as the next operation reminder; the record can also help a medical doctor or a health care provider to track the compliance of the user regarding the therapeutic regimen. Furthermore, to ensure users' safety in accessing/ using a medicament delivery device, there is also a demand for stopping users from accessing or using a medicament delivery device which has been used.

Electronic medicament delivery devices have been developed for allowing patients themselves to safely administer medicament, without the need for help from health professionals, and for allowing transmission of data to the health professionals. Data is generally transmitted by an electronic component that is powered by a battery integrated within the device or through a wired connection by an external power source. Nowadays, the material cost of electronics that can provide the above-mentioned functions is reducing. However, the cost of manufacture is increasing, by either the increasing cost of manpower or the increasing cost of making a more complicated automatic assembling machine, so there is still room for simplifying the assembling process for medicament delivery devices.

SUMMARY

The invention is defined by the appended claims, to which reference should now be made.

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 members 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.

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.

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

Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central 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. There is hence provided a sub-assembly of a medicament delivery device, the subassembly comprising a housing extending between a proximal end and a distal end along a longitudinal axis; wherein the housing is configured to accommodate a medicament container of the medicament delivery device; wherein the housing comprises an activator extending from the housing in a direction transverse to the longitudinal axis; a sensor assembly comprising a shell and a set of electronics at least partially placed within the shell; wherein the set of electronics comprises a processor and a switch electrically connected to the processor; wherein the switch is configured to be altered by the activator between a non-activated state and an activated state; wherein the shell of the sensor assembly is removably attached to the housing; wherein the shell comprises a proximal contact surface extending beyond the proximal end of the housing; wherein the proximal contact surface is configured to be operably in contact with a user of the medicament delivery device such that the shell of the sensor assembly is movable relative to the housing in the direction of the longitudinal axis between a first position where the switch of the sensor assembly is spaced apart from the activator of the housing and a second position where the switch of the sensor assembly is adjacent to the activator of the housing by the user of the medicament delivery device via the proximal contact surface of the shell such that the switch is altered from the non-activated state to the activated state by the activator when the shell is moved from the first position to the second position.

Preferably, according to another embodiment, the activator comprises a proximally directed surface.

Preferably, according to another embodiment, the switch comprises a distally directed surface engaged with the proximally directed surface of the activator when the sensor assembly is in the second position.

Preferably, according to another embodiment, the switch is a mechanical switch, the mechanical switch comprising the distally directed surface.

Preferably, according to another embodiment, the shell comprises a distally directed opening.

Preferably, according to another embodiment, the distally directed surface of the switch, the opening of the shell and the activator are lined up in the direction of the longitudinal axis such that the activator is at least partially positioned within the shell when the sensor assembly is in the second position.

Preferably, according to another embodiment, the activator comprises a base, a pin, and a biasing member, the biasing member extending between a proximal end and a distal end in the direction of the longitudinal axis.

Preferably, according to another embodiment, the pin comprises a distally directed surface engaged with the proximal end of the biasing member.

Preferably, according to another embodiment, the base comprises a proximally directed surface engaged with the distal end of the biasing member.

Preferably, according to another embodiment, the pin comprises the proximally directed surface of the activator.

Preferably, according to another embodiment, the pin is positioned extending into the shell through the opening when the shell is in the second position.

Alternatively, according to another embodiment, the switch is a non-contact switch.

Preferably, according to another embodiment, the switch is a reed switch; and wherein the activator comprises a magnet.

Preferably, according to another embodiment, the sub-assembly comprises a cap removably attached to the proximal end of the housing.

Preferably, according to another embodiment, the sensor assembly comprises a cap switch movable between a non-activated state when the cap is attached to the proximal end of the housing and an activated state when the cap is removed from the housing.

Preferably, according to another embodiment, the cap switch comprises a surface engaged with a counter surface of the cap such that the switch is in a non-activated state when the surface of the cap switch is engaged with the counter surface of the cap; wherein the shell comprises an opening lined up with the surface of the cap switch and the counter surface of the cap. Preferably, according to another embodiment, the surface of the cap switch is a proximally directed surface.

Preferably, according to another embodiment, the counter surface of the cap is a distally directed surface.

Preferably, according to another embodiment, the opening of the shell is a proximally directed opening.

Preferably, according to another embodiment, the proximal contact surface of the shell comprises a rim configured to be in contact with a medicament delivery site.

Preferably, according to another embodiment, the housing comprises a distally directed surface and a proximally directed surface.

Preferably, according to another embodiment, the shell of the sensor assembly comprises a distally directed surface engaged with the proximally directed surface of the housing when the sensor assembly is in the second position and a proximally directed surface engaged with the distally directed surface of the housing when the sensor assembly is in the first position.

Preferably, according to another embodiment, the shell comprises a fixture configured to be removably attached to the housing such that the sensor assembly is removably attached to the housing.

Preferably, according to another embodiment, the set of electronics comprises a biasing member configured to bias the switch from the non-activated state to the activated state.

Preferably, according to another embodiment, the biasing member is a spring or a flexible arm or a rubber.

Preferably, according to another embodiment, the spring is a leaf spring, a compression spring, a tension spring or a torsion spring.

Preferably, according to another embodiment, the switch is pivotal between the nonactivated state and the activated state. Preferably, according to another embodiment, the switch is pivotal on a plane parallel to the longitudinal axis.

Preferably, according to another embodiment, the cap switch comprises a surface engaged with a counter surface of the cap such that the switch is in a non-activated state when the surface of the cap switch is engaged with the counter surface of the cap.

Preferably, according to another embodiment, the set of electronics comprises a second biasing member configured to bias the cap switch from the non-activated state to the activated state.

Preferably, according to another embodiment, the second biasing member is a spring or a flexible arm or a rubber.

Preferably, according to another embodiment, the cap switch is pivotal between the non-activated state and the activated state.

Preferably, according to another embodiment, the cap switch is pivotal on a plane parallel to the longitudinal axis.

Preferably, according to another embodiment, the counter surface of the cap is configured to press the cap switch against the biasing force from the second biasing member when the cap is attached to the housing.

Preferably, according to another embodiment, the surface of the cap switch is a proximally directed surface, and the counter surface of the cap is a distally directed surface.

Preferably, according to another embodiment, the surface of the cap switch is facing in the direction transverse to the longitudinal axis, and the counter surface of the cap is facing towards the surface of the cap switch.

Preferably, according to another embodiment, the shell comprises an opening lined up with the surface of the cap switch and the counter surface of the cap. Preferably, according to another embodiment, the surface of the cap switch is a proximally directed surface

Preferably, according to another embodiment, the counter surface of the cap is a distally directed surface

Preferably, according to another embodiment, the cap comprises a protrusion extending in a direction transverse to the longitudinal axis. The counter surface is defined by the protrusion.

Preferably, according to another embodiment, the set of electronics comprises a battery.

Preferably, according to another embodiment, the set of electronics comprises an energy harvester circuit configured to wirelessly harvest electrical energy.

Preferably, according to another embodiment, the energy harvester circuit is an RF energy harvesting circuit.

Preferably, according to another embodiment, the cap switch is electrically connected between the battery and the processor when the switch is in the activated state and is disconnected between the battery and the processor when the switch is in the non-activated state.

Preferably, according to another embodiment, the cap switch is electrically connected between the energy harvester circuit and the processor when the switch is in the activated state and is disconnected between the battery and the processor when the switch is in the non-activated state.

Preferably, according to another embodiment, the switch is electrically connected between the battery and the processor when the switch is in the activated state and is disconnected between the battery and the processor when the switch is in the non-activated state.

Preferably, according to another embodiment, the switch is electrically connected between the energy harvester circuit and the processor when the switch is in the activated state and is disconnected between the battery and the processor when the switch is in the non-activated state.

Preferably, according to another embodiment, the set of electronics comprises a communication unit connected to the processor.

Preferably, according to another embodiment, the communication unit is configured to wirelessly send out and/or receive a signal.

Preferably, according to another embodiment, the sub-assembly comprises a delivery member guard telescopically arranged relative to the proximal end of the housing. The delivery member guard is configured to surround the medicament delivery member once the cap body is removed from the housing.

Preferably, according to another embodiment, the sub-assembly is used in a medicament delivery device. The medicament delivery device comprises a medicament container containing medicament, and a medicament delivery member operably connected to the medicament container for delivering the contained medicament.

Preferably, according to another embodiment, the medicament delivery member of the medicament delivery device is a needle or a spray nozzle.

Preferably, according to another embodiment, the medicament container of the medicament delivery device is a syringe, a cartridge or a collapsible bag.

Preferably, according to another embodiment, the medicament container of the medicament delivery device is made of glass material or plastic material.

Preferably, according to another embodiment, the medicament delivery device is an injection device, an inhalation device, or a medical sprayer.

Preferably, according to another embodiment, the medicament delivery device is an auto-injector.

Preferably, according to another embodiment, the medicament delivery device is a hand-held, pen-type auto-injector. 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, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies 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)) , ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. 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 activated ingredients, or may be the only activated ingredient present.

Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD- 1/PD-L1 inhibitors/modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TCR therapies.

Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21 , Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811 , HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini- BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

Furthermore, 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 element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

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

Fig. 1 schematically shows a perspective view of a medicament delivery device with a sub-assembly of the invention;

Fig. 2 schematically shows a cross-section view of a proximal portion of Fig. 1 ; Fig. 3 schematically shows a perspective view of a switch of a set of electronics of the sub-assembly of the invention and a protrusion of a housing of the sub-assembly of the invention; and

Fig. 4 schematically shows a perspective view of the switch of Fig. 3.

Figs 5-10 schematically show an operation sequence of the invention.

DETAILED DESCRIPTION

Figs 1-4 illustrate a medicament delivery device with a sensor assembly. The sensor assembly is detachably connected to the medicament delivery device. The medicament delivery device comprises a medicament container M containing a medicament and a medicament delivery member operably connected to the medicament container for delivering the contained medicament. In one example, the medicament container is a syringe, and the medicament delivery member is a needle. In this example, the needle is integral at a proximal end of the syringe. Alternatively, the medicament container can be a cartridge, and the medicament delivery member is a needle that is preassembled to the medicament delivery device and is configured to fluidly communicate with the cartridge during use. Alternatively, the medicament container is a collapsible bag. For example, the medicament delivery device comprises a container carrier. In one example, the medicament container is made of plastic.

The sub-assembly comprises a housing 1 and a sensor assembly 2. The housing 1 extends along a longitudinal axis L between a proximal end and a distal end, as shown in Fig. 2. The housing 1 is configured to accommodate the medicament container M, as shown in Fig. 2. In a preferred example, the housing 1 is shaped to match the shape of the medicament container M. For example, most of the medicament containers have a cylindrical body. Therefore, the housing 1 is shaped to be cylindrical. Additionally, the housing might comprise an anti-rolling feature that is configured to prevent the housing body from rolling on a flat surface. In one example, the anti-rolling feature can be one or more protrusions extending from an outer surface of the housing body. Alternatively, the anti-rolling feature can be provided by the housing body being shaped with a portion that has a non-circular cross-section when observed along the longitudinal axis L. For example, the housing body might have a triangle-shaped cross-section. The sub-assembly optionally comprises a delivery member guard 5. As shown in Figs 1-2, the delivery member guard 5 is telescopically arranged relative to the housing, e.g., being based in the proximal direction relative to the housing by a delivery member guard spring. In a preferred example, the delivery member guard 5 is arranged within the housing 1 , as shown in Fig. 1 . In a preferred example, the delivery member guard 5 is shaped to match the shape of the housing body. In a preferred example, the delivery member guard 5 is tubular and is arranged between an inner wall of the housing body and the medicament container in a direction transverse to the longitudinal axis L.

The housing 1 comprises an activator 3 extending from the housing 1 in a direction transverse to the longitudinal axis 1 . The activator can be an integral part of the housing, e.g., a protrusion extending from the housing. Alternatively, the activator can be immovably attached to the housing, e.g., by being glued, welded, or a snap- fit.

The sensor assembly 2 comprises a shell 20 a set of electronics at least partially placed within the shell 20. The set of electronics comprises a processor and a switch 22 electrically connected to the processor. The switch 22 is configured to be altered between a non-activated state and an activated state by the activator 3. In one example, the processor is configured to get an electric signal when the switch is movable between a non-activated state and an activated state. In one example, the processor is not powered by a power source, e.g., a battery or an energy harvest circuit, when the switch is in the non-activated state; and the processor is powered by the power source when the switch is in the activated state. Alternatively, the processor is configured to consume relatively less energy when the switch is in the non-activated state comparing a cap switch (it should be noted that, the cap switch and the switch are two different, and electrically independent components) is in the activated state. In one example, the processor is configured to detect that the switch remains in the activated state.

The shell 20 of the sensor assembly 2 is removably attached to the housing 1 such that the sensor assembly 2 is removably attached to the housing 1 via the shell 20. In one preferred example, the shell comprises a fixture configured to be removably attached to the housing such that the sensor assembly is removably attached to the housing. In one example, the sensor assembly is configured to be attached to and detached from the housing by an end user. In this example, the fixture can be a circlip or a sleeve with a hinged door. Alternatively, the sensor assembly is configured to be attached to and detached from the housing by medical care practitioners or medical device recycling professionals. In this example, the sensor assembly can be attached to and detached from the housing via a magnetic buckle that can only be removed by a specific remover or a sleeve with a hinged door that is locked via a lock.

The shell 20 comprises a proximal contact surface 21a extending beyond the proximal end of the housing 1. The proximal contact surface 21a is configured to be operably in contact with a user of the medicament delivery device such that the shell 20 of the sensor assembly 2 is movable relative to the housing 1 in the direction of the longitudinal axis L between a first position where the switch 22 of the sensor assembly 2 is spaced away from the activator 3 of the housing 1 , as shown in Fig. 2, and a second position where the switch 22 of the sensor assembly 2 is adjacent to the activator 3 of the housing 1 , as shown in Fig. 1 , such that the switch 22 is altered from the non-activated state to the activated state by the activator 3 when the shell 20 is moved from the first position to the second position.

Therefore, when the end user starts to use the medicament delivery device by pressing the housing 1 towards a medicament delivery site, the shell 20 can be moved in the distal direction relative to the housing 1. In one example, the proximal contact surface 21a is configured to be directly in contact the end user. For example, the contact surface 21a is lined up in the direction transverse to the longitudinal axis L with a proximal-most surface of the delivery member guard that is configured to be contact with the skin of the user or the contact surface 21a further protrudes beyond the proximal end of the delivery member guard or in the example where the medicament delivery device doesn’t comprises a delivery member guard, the contact surface 21a is configured to be the proximal end of the medicament delivery device comprises the sub-assembly. Alternatively, in one example where the sub-assembly comprises the delivery member guard 5, the proximal contact surface can be configured to contact a part of the delivery member guard 5; in other words, the proximal contact surface is configured to be indirectly in contact the end user. In this example, the shell is configured to be moved either together with the delivery member guard or can only be moved once the delivery member guard is retracted a curtained distance within the housing. In one example, the housing comprises a distally directed surface and a proximally directed surface; and the shell of the sensor assembly comprises a distally directed surface engaged with the proximally directed surface when the sensor assembly is in the second position and a proximally directed surface engaged with the distally directed surface of the housing when the sensor assembly is in the proximally directed surface. For example, a groove is arranged in a wall of the housing. The groove extends in the direction of the longitudinal axis L. In this example, the shell of the sensor assembly comprises a rib positioned within the groove of the housing.

Alternatively, the shell is attached to the housing via a flexible stripe, e.g., a rubber stripe, in this example, the sensor assembly 2 is movable relative to the housing 1 in the direction of the longitudinal axis L by expanding the flexible stripe. In other words, the movable distance of the sensor assembly relative to the housing can be determined by the resilience of the flexible stripe.

The senor assembly 2 is configured to be moved relative to the housing by the end user when the end user starts to use the medicament delivery device.

In a preferred example, the activator 3 comprises a proximally directed surface 31 . The switch comprises a distally directed surface 22a engaged with the proximally directed surface of the activator when the sensor assembly 2 is in the second position, as shown in Fig. 1 .

In another example, the switch is a mechanical switch comprising the distally directed surface. In a preferred example, the shell 20 comprises a distally directed opening 20a. The distally directed surface 22a of the switch 22, the opening 20a of the shell 20 and the activator 3 are lined up in the direction of the longitudinal axis L such that the activator 3 is at least partially positioned within the sensor assembly 20 when the shell 20 is in the second position, as shown in Fig. 1.

In another example, as shown in Figs 1-2, the activator 3 comprises a base 30, a pin 31 , and a biasing member 32 extending between a proximal end and a distal end in the direction of the longitudinal axis L. The pin 31 comprises a distally directed surface engaged with the proximal end of the biasing member 32. The base 30 comprises a proximally directed surface engaged with the distal end of the biasing member 32. The pin 31 comprises the proximally directed surface 31a of the activator 3.

In a preferred example, the pin is positioned within the shell through the opening when the shell is in the second position.

Furthermore, in another example, the sensor assembly can be designed to be movable relative to the housing only in a certain direction by the pin. In this example, the pin comprises a distally directed surface configured to be engaged with an inner proximally directed surface of the shell; therefore, the maximum moving distance of the shell relative to the housing in the proximal direction of the housing can be limited by the pin. On the other hand, the maximum moving distance of the shell relative to the housing in the distal direction of the housing can be limited by a distal edge of the shell and a proximally directed surface of the base.

In one example where the switch is a mechanical switch, the set of electronics comprises a biasing member configured to bias the switch from the non-activated state to the activated state. In another example, the biasing member is a spring or a flexible arm or a rubber. In a preferred example, the spring is a leaf spring, a compression spring, a tension spring or a torsion spring.

In one example, the switch 22 is pivotal between the non-activated state and the activated state. In a preferred example, the switch 22 is pivotal on a plane parallel to the longitudinal axis L, as shown in Figs 1-2.

Alternatively, the switch is a non-contact switch. For example, the switch is a reed switch; and the activator comprises a magnet. In this example, the switch does not need to be in contact with the activator to be switched to the activated state. When the switch is adjacent to the activator, the magnet switch on the reed switch, thus the switch is moved from the non-activated state to the activated state. In another example, the switch is an induction sensor. For example, the switch comprises an induction coil and the activator can be arranged as a previously mentioned example, the activator comprises the base and the pin. In this example, the pin can be a magnet configured to be moved into the induction coil of the switch.

Furthermore, in a preferred example, wherein the proximal contact surface of the shell comprises a rim 21 configured to be in contact with a medicament delivery site. In a preferred example, the rim 21 can be arranged to provide sensation to the end user to disturb the end user from the uncomfortable feeling caused by the medicament delivery operation, e.g., pain or soreness. The rim 21 can also be used to increased the contact surface between the medicament delivery device and the medicament delivery site. Furthermore, the rim 21 can flat the medicament delivery site; therefore, a certain medicament delivery angle can be secured, e.g., a vertical injection angle relative to the skin. In one example, the shell comprises a ring providing the rim.

Furthermore, in another example, the sub-assembly comprises a cap removably 4 attached to the proximal end of the housing 1 , as shown in Figs 3-4. In a preferred example, the sensor assembly comprises the cap switch movable between a nonactivated state when the cap is attached to the proximal end of the housing and an activated state when the cap is removed from the housing.

Similarly, the processor is configured to get an electric signal when the cap switch is movable between a non-activated state and an activated state. In one example, the processor is not powered by a power source, e.g., a battery or an energy harvest circuit, when the cap switch is in the non-activated state; and the processor is powered by the power source when the cap switch is in the activated state. Alternatively, the processor is configured to consume relatively less energy when the cap switch is in the non-activated state comparing the cap switch is in the activated state. In one example, the processor is configured to detect that the cap switch remains in the activated state.

In a preferred example, the cap switch comprises a surface engaged with a counter surface of the cap such that the switch is in a non-activated state when the surface of the cap switch is engaged with the counter surface of the cap. In a preferred example, the shell comprises an opening lined up with the surface of the cap switch and the counter surface of the cap.

In another example, the surface of the cap switch is a proximally directed surface and the counter surface of the cap is a distally directed surface. The opening of the shell is a proximally directed opening.

Similarly, as the switch, the cap switch can be non-contact switch, e.g., a reed switch or an induction sensor; or a mechanical switch that is being biased by a second biasing member from the non-activated state to the activated state. The second biasing member can be a spring, e.g., a leaf spring, a compression spring, a tension spring or a torsion spring, or a flexible arm or a rubber.

In one example, the cap switch is pivotal between the non-activated state and the activated state. In another example, the cap switch is pivotal on a plane parallel to the longitudinal axis L. In one example, the counter surface of the cap is configured to press the cap switch against the biasing force from the second biasing member when the cap is attached to the housing.

Furthermore, in another example, the set of electronics comprises a battery and/or an energy harvester circuit, e.g., an RF energy harvesting circuit configured to wirelessly harvest electrical energy.

In one example, the switch and/or cap switch is electrically connected between the battery and the processor when the switch is in the activated state and is disconnected between the battery and the processor when the switch is in the nonactivated state. Alternatively, the switch and/or cap switch is electrically connected between the energy harvester circuit and the processor when the switch is in the activated state and is disconnected between the battery and the processor when the switch is in the non-activated state.

In another example, the set of electronics comprises a communication unit connected to the processor. The communication unit is configured to wirelessly send out and/or receive a signal.

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.

In one example, the processor can be a micro control unit (MCU). In one example, the set of electronics comprises at least one of a memory, a clock, a communication unit, an indicator and/ or a sensor,

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. 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 a LED light emitter and/or the indicator can be a haptic indicator, such as a vibrator.

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, vibration sensor or contact sensor.

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.

As all electronics are arranged at least partially within the shell of the sensor assembly, and the sensor assembly can be removed from the housing, the sensor assembly and the housing with the medicament container can be easily recycled independently. The sensor assembly can be treated as electronics waste or can be simply reset and reused. The housing with the medicament container can be treated as medical waste. Furthermore, in the example where the sensor assembly comprises the cap switch, as the cap is attached to the proximal end of the housing and the medicament delivery site will be close to the proximal end of the housing, the sensor assembly can be small, e.g., positioned to the proximal end of the housing. Furthermore, in this example, the user's behavior of cap removal and carrying out medicament delivery operation can be detected, a period between these two events can be calculated, and a period that the uses hold the medicament delivery device against the medicament delivery site can also be calculated.

The medicament delivery device with the sub-assembly as disclosed above can be used with the following steps with the following order (as shown in Figs 5-10):

• the user is provided with the medicament delivery device with the subassembly as disclosed above, as shown in Fig. 5;

• when the user plans to use the medicament delivery device, the user will remove the cap 4 from the housing 1 , as shown in Fig. 6;

• the user presses the delivery member guard 5 of the medicament delivery device against the medicament delivery site, as shown in Fig. 7;

• once the delivery member guard 5 is moved to a predetermined position, e.g., a position that the medicament delivery operation is start, the proximal contact surface 21a of the shell 20 of the sensor assembly 2 is in contact with the medicament delivery site; as a result, the shell 20 is moved from the first position to the second position, as shown with arrow X in Fig. 8;

• once the medicament delivery operation is completed, the user removes the medicament delivery device from the medicament delivery site; in one example, where the shell 20 is biased in the proximal direction relative to the housing 1 , the shell 20 is moved back to the first position when the user removes the medicament delivery device from the medicament delivery site, as shown with arrow Y in Fig. 9;

• the user disposes a used medicament delivery device, e.g., brings back to a pharmacy, the sensor assembly 2 is removed for recycling, as shown in Fig. 10.

• The recipient of the used medicament delivery device separates the electronics part and the part without electronics.

In one example where all functions or the major functions of the set of electronics can be provided only when the cap switch and the switch are both in activated state; in other words, the set of electronics are activated only when the cap switch and the switch are both in activated state, preferably, when the cap is attached to the housing, the cap is configured to retain the shell of the sensor assembly in the second position so that the user cannot accidentally move the shell relative to the housing when the cap is attached to the housing.

Furthermore, the housing, as mentioned in any example, may be provided with (i.e., molded in, molded with) a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties. Alternatively, a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties may be applied to the molded (i.e., finished) components through secondary processes (e.g., chemical vapor deposition), spraying, or dipping processes.

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

1 . A sub-assembly of a medicament delivery device, the sub-assembly comprising: a housing (1) extending between a proximal end and a distal end along a longitudinal axis (L); wherein the housing (1) is configured to accommodate a medicament container of the medicament delivery device; wherein the housing (1) comprises an activator (3) extending from the housing (1) in a direction transverse to the longitudinal axis (L); a sensor assembly (2) comprising a shell (20) and a set of electronics at least partially placed within the shell (20); wherein the set of electronics comprises a processor and a switch (22) electrically connected to the processor; wherein the switch (22) is configured to be altered by the activator between a non-activated state and an activated state; wherein the shell (20) of the sensor assembly (2) is removably attached to the housing (1); wherein the shell (20) comprises a proximal contact surface (21a) extending beyond the proximal end of the housing (1); wherein the proximal contact surface (21a) is configured to be operably in contact with a user of the medicament delivery device such that the shell (20) of the sensor assembly (2) is movable relative to the housing (1) in the direction of the longitudinal axis (L) between a first position where the switch (22) of the sensor assembly (2) is spaced apart from the activator (3) of the housing (1) and a second position where the switch (22) of the sensor assembly (2) is adjacent to the activator (3) of the housing (1) by the user of the medicament delivery device via the proximal contact surface (21a) of the shell (20) such that the switch (22) is altered from the non-activated state to the activated state by the activator (3) when the shell (20) is moved from the first position to the second position.

2. The sub-assembly according to claim 1 , wherein the activator comprises a proximally directed surface (31); and wherein the switch comprises a distally directed surface (22a) engaged with the proximally directed surface of the activator when the sensor assembly (2) is in the second position.

3. The sub-assembly according to claim 2, wherein the switch is a mechanical switch, the mechanical switch comprising the distally directed surface; wherein the shell comprises a distally directed opening; and wherein the distally directed surface of the switch, the opening of the shell and the activator are lined up in the direction of the longitudinal axis such that the activator is at least partially positioned within the shell when the sensor assembly is in the second position.

4. The sub-assembly according to claim 2 or 3, wherein the activator comprises a base, a pin, and a biasing member, the biasing member extending between a proximal end and a distal end in the direction of the longitudinal axis; wherein the pin comprises a distally directed surface engaged with the proximal end of the biasing member; wherein the base comprises a proximally directed surface engaged with the distal end of the biasing member; wherein the pin comprises the proximally directed surface of the activator.

5. The sub-assembly according to claim 4, wherein the pin is positioned extending into the shell through the opening when the shell is in the second position.

6. The sub-assembly according to claim 1 or 2, wherein the switch is a noncontact switch.

7. The sub-assembly according to claim 6, wherein the switch is a reed switch; and wherein the activator comprises a magnet.

8. The sub-assembly according to any of the preceding claims, wherein the sub-assembly comprises a cap removably attached to the proximal end of the housing; wherein the sensor assembly comprises a cap switch movable between a non-activated state when the cap is attached to the proximal end of the housing and an activated state when the cap is removed from the housing.

9. The sub-assembly according to claim 8, wherein the cap switch comprises a surface engaged with a counter surface of the cap such that the switch is in a non-activated state when the surface of the cap switch is engaged with the counter surface of the cap; wherein the shell comprises an opening lined up with the surface of the cap switch and the counter surface of the cap.

10. The sub-assembly according to claim 9, wherein the surface of the cap switch is a proximally directed surface; wherein the counter surface of the cap is a distally directed surface; and wherein the opening of the shell is a proximally directed opening.

11 . The sub-assembly according to any of the preceding claims, wherein the proximal contact surface of the shell comprises a rim configured to be in contact with a medicament delivery site.

12. The sub-assembly according to any of the preceding claims, wherein the housing comprises a distally directed surface and a proximally directed surface; wherein the shell of the sensor assembly comprises a distally directed surface engaged with the proximally directed surface of the housing when the sensor assembly is in the second position and a proximally directed surface engaged with the distally directed surface of the housing when the sensor assembly is in the first position.

13. The sub-assembly according to any of the preceding claims, wherein the shell comprises a fixture configured to be removably attached to the housing such that the sensor assembly is removably attached to the housing.