WO2024110209A1

WO2024110209A1 - A distal lid of a medicament delivery device

Info

Publication number: WO2024110209A1
Application number: PCT/EP2023/081383
Authority: WO
Inventors: Daniel SÄLL; Mattias Myrman; Plamen BALKANDJIEV
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2022-11-25
Filing date: 2023-11-10
Publication date: 2024-05-30
Anticipated expiration: 2025-05-25
Also published as: EP4622690A1; JP2025537914A

Abstract

A distal lid of a medicament delivery device, wherein the distal lid is configured to cover a distal end of a housing of the medicament delivery device, the distal lid comprising: a sleeve body extending along a longitudinal axis between a proximal end and a distal end; wherein the sleeve body comprises a central cavity configured to receive a movable indicator of the medicament delivery device; a lid cover extending from the distal end of the sleeve body in a direction transverse to the longitudinal axis; a set of electronics comprising a battery, a circuit and a switch electrically connected to the battery and the circuit; wherein the set of electronics is at least partially positioned between the lid cover and the sleeve body in the direction of the longitudinal axis; wherein the switch is altered between an second state where the circuit is in a working mode and an first state where the circuit is in a low-power mode; and wherein the switch is aligned with the central cavity of the sleeve body in the direction of the longitudinal axis such that the switch is configured to be altered from the first state to the second state when the movable indicator of the medicament delivery device moves towards the lid cover.

Description

TITLE

A distal lid of a medicament delivery device.

TECHNICAL FIELD

The present disclosure generally relates to a distal lid of a medicament delivery device, and particularly to a distal lid of a medicament delivery device comprising a set of electronics.

BACKGROUND

Medicament delivery devices such as pen-type manual injectors or auto-injectors are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes may require repeated injections of insulin, or patients may require regular injections of other types of medicaments, such as growth hormones.

It is an advantage when the medicament delivery devices for self-administration comprise automatic functions so that even if users are without professional training or are in an emergency situation, the users can easily and properly use the medicament delivery devices. However, those users who are without professional training might need more instructions/indications to understand how to use the medicament delivery devices properly. Therefore, there is a demand to incorporate a set of electronics providing sensors, indicators and/or data receiving/transmitting functions to the medicament delivery devices for providing more instructions/indications to those users who are without professional training.

Nowadays, the material cost of electronics that can provide the above-mentioned functions is reducing. However, the cost of assembling is increasing, by either the increasing cost of manpower or the increasing cost of making a more complicated automatic assembling machine, therefore, there is still room for simplifying the assembling process of 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 distal lid of a medicament delivery device, wherein the distal lid is configured to cover a distal end of a housing of the medicament delivery device, the distal lid comprising: a sleeve body extending along a longitudinal axis between a proximal end and a distal end; wherein the sleeve body comprises a central cavity configured to receive a movable indicator of the medicament delivery device; a lid cover extending from the distal end of the sleeve body in a direction transverse to the longitudinal axis; a set of electronics comprising a battery, a circuit and a switch electrically connected to the battery and the circuit; wherein the set of electronics is at least partially positioned between the lid cover and the sleeve body in the direction of the longitudinal axis; wherein the switch is configured to be altered between a first state where the circuit is in a low-power mode and a second state where the circuit is in a working mode; and wherein the switch is aligned with the central cavity of the sleeve body in the direction of the longitudinal axis such that the switch is configured to be altered, by the movable indicator, from the first state to the second state when the movable indicator of the medicament delivery device moves towards the lid cover.

Preferably, according to another embodiment, the sleeve body is configured to be at least partially inserted into the distal end of the housing of the medicament delivery device.

Preferably, according to another embodiment, the lid cover is integral to the sleeve body.

Alternatively, according to another embodiment, the lid cover is attached to the sleeve body via at least one of a snap-fit, a press-fit, a screw or a bayonet fixture. Preferably, according to another embodiment, an opening is formed between the lid cover and the sleeve body; wherein the opening is open in the direction transverse to the longitudinal axis.

Preferably, according to another embodiment, the sleeve body comprises a flexible arm defined by two cut-outs in a wall of the sleeve body.

Preferably, according to another embodiment, a protrusion extends from the flexible arm in the direction transverse to the longitudinal axis.

Preferably, according to another embodiment, the protrusion is configured to releasably engage with a plunger rod of the medicament delivery device.

Preferably, according to another embodiment, the protrusion is configured to interact with a plunger rod of the medicament delivery device to generate an audible/tactile indication to a user.

Preferably, according to another embodiment, the sleeve body comprises a flexible portion extending from the proximal end of the sleeve body.

Preferably, according to another embodiment, the flexible portion is compressible in the direction of the longitudinal axis.

Preferably, according to another embodiment, the flexible portion is configured to be in contact with a medicament container of the medicament delivery device.

Preferably, according to another embodiment, the flexible portion is a plastic spring.

Alternatively, according to another embodiment, the flexible portion is a proximally extending flexible arm.

Preferably, according to another embodiment, the circuit is electrically connected to the battery via the switch when the switch is in the second state.

Preferably, according to another embodiment, the electrical connection between the circuit and the battery is interrupted when the switch is in the first state.

Preferably, according to another embodiment, the switch is a mechanical switch configured to be in contact with the movable indicator of the medicament delivery device such that the switch is altered to the second state when the switch is in contact with the movable indicator of the medicament delivery device. Preferably, according to another embodiment, the switch is configured to be pushed by the movable indicator of the medicament delivery device in the distal direction relative to the sleeve body.

Preferably, according to another embodiment, the switch is configured to be in contact with the movable indicator of the medicament delivery device to close a loop that comprises the circuit and the battery.

Preferably, according to another embodiment, the switch is configured to be pushed by the movable indicator of the medicament delivery device in the distal direction relative to the sleeve body to close a loop that comprises the circuit and the battery.

Preferably, according to another embodiment, the switch is a non-contact switch such that the switch is configured to be altered to the second state when the movable indicator of the medicament delivery device moves towards the switch by a predetermined distance.

Preferably, according to another embodiment, the circuit is connected to at least one of a microprocessor, a data transmitter, a data receiver, a buzzer, a light emitter, a vibration motor, a memory and a sensor.

Preferably, according to another embodiment, the distal lid is used in a sub-assembly of the medicament delivery device.

Preferably, according to another embodiment, the sub-assembly comprising: an indicator movable within the central cavity of the sleeve body; wherein the indicator comprises a proximally directed surface; a compression spring extending between a proximal end and a distal end that is engaged with the proximally directed surface of the indicator; and a retaining mechanism configured to releasably hold the indicator against the force from the compression spring.

Preferably, according to another embodiment, the sub-assembly comprises a plunger rod comprising a distally directed surface engaged with the proximal end of the compression spring.

Alternatively, according to another embodiment, the sub-assembly comprises a delivery member guard comprising a distally directed surface engaged with the proximal end of the compression spring.

Preferably, according to another embodiment, the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring until an end of a medicament delivery operation of the medicament delivery device. Preferably, according to another embodiment, the retaining mechanism comprises the plunger rod.

Preferably, according to another embodiment, the plunger rod is at least partially arranged within the central cavity of the sleeve body before the end of the medicament delivery operation.

Preferably, according to another embodiment, the indicator comprises a flexible arm extending between the sleeve body and the plunger rod.

Preferably, according to another embodiment, the flexible arm comprises a proximally extending protrusion bevelled relative to the longitudinal axis.

Preferably, according to another embodiment, the flexible arm is blocked by the plunger rod from flexing towards the longitudinal axis such that the proximal extending protrusion is engaged with a proximal end edge of the sleeve body when the plunger rod is received within the central cavity of the sleeve body.

Preferably, according to another embodiment, the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring before the plunger rod is released to carry out a medicament delivery operation.

Preferably, according to another embodiment, the distal lid is used in a medicament delivery device comprising a multiple-chamber medicament container arranged within a carrier of the medicament delivery device.

Preferably, according to another embodiment, the sub-assembly is used in a medicament delivery device comprising a multiple-chamber medicament container arranged within the carrier of the medicament delivery device.

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 autoinjector. Preferably, according to another embodiment, the medicament delivery member is an injection needle or a spray nozzle.

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, fam-trastuzumab 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 active ingredients, or may be the only active 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 bio-oncology 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, EB-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 TOR 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, TAG, 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 distal lid of the invention;

Fig. 2 schematically shows a cross-section view of the distal lid of Fig. 1 ;

Fig. 3 schematically shows a cross-section view of the distal lid of Fig. 1 with a movable indicator of a medicament delivery device that comprises the distal lid;

Fig. 4 schematically shows a cross-section view of another example of the distal lid of Fig. 1 with a movable indicator of a medicament delivery device that comprises the distal lid;

Fig. 5 schematically shows a perspective view of the step of assembling the distal lid of Fig. 1 ;

Fig. 6 schematically shows a perspective view of another example of the step of assembling the distal lid of Fig. 1;

Figs 7A-7B schematically show perspective views of the step of assembling the distal lid of Fig. 1 to a housing of the medicament delivery device;

Fig. 8 schematically shows a perspective view of the distal lid of Fig. 1 arranged with a medicament container of the medicament delivery device that comprises the distal lid; and Figs 9A-9B schematically show cross-section views of a sub-assembly comprising the distal lid of Fig. 1.

Figs 10A-10B schematically shows a perspective view of the distal lid of the invention in another example.

DETAILED DESCRIPTION

Figs 1-10B illustrate some examples of distal lids of a medicament delivery device. The distal lid 1 is configured to cover a distal end of a housing 2 of the medicament delivery device such that a medicament container within the medicament delivery device will not fall out and/or the components within the housing 2 of the medicament delivery device can be prevented from environmental contamination, as shown in Figs 7A-7B.

In one example, the distal lid 1 forms a part of a fully assembled medicament delivery device or, rather than an add-on device that is configured to be releasably attached to a fully assembled medicament delivery device. In one example, the medicament delivery device cannot perform the designed functions, e.g. deliver the contained medicament, without the distal lid. Furthermore, from the medicament regulation aspect, the medicament delivery device with the distal lid as disclosed in this description will be submitted together as one product for a review that can grant the medicament delivery device a marketing approval.

The distal lid 1 comprises a sleeve body 10; 10’, a lid cover 11 ; 11’, and a set of electronics 12; 12’. The sleeve body 10; 10’ extends along a longitudinal axis L between a proximal end and a distal end, as shown in Fig. 1. The sleeve body 10; 10’ comprises a central cavity 101 configured to receive a movable indicator 3 of the medicament delivery device, as shown in Fig. 2. In one example, the sleeve body 10; 10' is configured to be at least partially inserted into the distal end of the housing 2 of the medicament delivery device. As most of the medicament containers, e.g., syringes or cartridges are cylindrical, most of the housings of the medicament delivery devices are also cylindrical so that the housing can match the shape of the medicament container and avoid the medicament container from rattling within the housing, thus, in a preferred example, the sleeve body 10; 10' is cylindrical. Alternatively, the sleeve body can be other shapes that match the shape of the distal end of the housing of the medicament delivery device. In another example, the sleeve body 10; 10’ comprises two sections having two diameters respectively. In this example, one section of the sleeve body is configured to be inserted fully into the distal end of the housing of the medicament delivery device; the other section of the sleeve body is configured to receive the set of electronics 12; 12’. In this example, the set of electronics can be sized greater than the diameter of the housing of the medicament delivery device. Furthermore, the sleeve body 10; 10’ can be configured to provide some automatic functions of the medicament delivery device. For example, the sleeve body 10 comprises a flexible arm 103 defined by two cut-outs in a wall of the sleeve body, as shown in Fig.1 . A protrusion 103a extending from the flexible arm 103 in the direction transverse to the longitudinal axis, as shown in Fig. 2. The protrusion 103a is configured to releasably engage with a plunger rod 6 of the medicament delivery device. For example, the medicament delivery device may comprise another component to releasably block the flexible arm 103 of the sleeve body 10, therefore, the plunger rod 6 can be held to the housing 2 of the medicament delivery device before a medicament delivery operation is carried out and can be released to carry out the medicament delivery operation. In another example, the protrusion 103a is configured to releasably engage with multiple clicking elements of the plunger rod of the medicament delivery device, a continuous click sound can be generated during the medicament delivery operation. The multiple clicking elements can be protrusions, recesses, and/or cut-outs extending from an outer wall of the plunger rod of the medicament delivery device.

Furthermore, the sleeve body 10 comprises a flexible portion 102 extending from the proximal end of the sleeve body 10, as shown in Fig. 8. The flexible portion 102 is compressible in the direction of the longitudinal axis L. The flexible portion 102 is configured to be in contact with a medicament container S of the medicament delivery device, as shown in Fig. 8. Therefore, medicament containers with different lengths can be compensated by compressing the flexible portion 102 of the sleeve body 10. In one example, the flexible portion is a plastic spring. Alternatively, the flexible portion 102 is a proximally extending flexible arm, as shown in Fig. 8.

The lid cover 11 ; 1 T extends from the distal end of the sleeve body 10; 10’ in a direction transverse to the longitudinal axis L, as shown in Fig. 2. In one example, the lid cover 11 is integral to the sleeve body 10, as shown in Fig. 5. Alternatively, the lid cover 1 T is attached to the sleeve body 10’ via at least one of a snap-fit, a press-fit, a screw or a bayonet fixture, as shown in Fig. 6. In other words, the lid cover 1 T and the sleeve body 10’ can be two independent components and be configured to be attached to one another to form the distal lid. In this example, the set of electronics in the distal lid is easier to be recycled once the medicament delivery device is used. In one example, the distal cover 11 ; 1 T is shaped to match to the shape of the distal end of the sleeve body 10; 10’. In another example, the distal cover is transparent so that the set of electronics may comprises a visual indicator, e.g., LED lights, that is configured to be observed through the distal cover 11 ; 1 T.

In one example, an opening 13; 13’ is formed between the lid cover 11 and the sleeve body 10. The opening 13; 13’ is open in the direction transverse to the longitudinal axis L, as shown in Fig. 5 and Fig. 10B. In the example where the lid cover 1 T and the sleeve body 10’ are two independent components and are configured to be attached to one another, the sleeve body 10’ can be inserted into the distal end of the housing of the medicament delivery device, followed by the set of electronics 12; 12’ being placed on the sleeve body 10’, after which the lid cover 11 ’ is attached to the sleeve body 10’. Alternatively, the sleeve body 10’ and the lid cover 11 ’ can be attached to one another and has the set of electronics in between, followed by the distal lid being inserted into the distal end of the housing of the medicament delivery device.

The set of electronics 12; 12’; 12” comprises a battery 121, a circuit 120 and a switch 122 electrically connected to the battery 121 ; 12T and the circuit 120. The set of electronics 12; 12’; 12” is at least partially positioned between the lid cover 11 ; 1 T and the sleeve body 10; 10’ in the direction of the longitudinal axis L. In the example as shown in Fig. 4, the set of electronics 12; 12’ is fully positioned between the lid cover 11 ; 1 T. Alternatively, in another example as shown in Figs 10A-10B, the set of electronics 12” is partially positioned between the lid cover 11 and the sleeve body 10. In a preferred example as shown in Fig. 10A, the circuit 120 and the switch 122 are positioned between the lid cover 11 and the sleeve body

10, and the battery 12T is positioned adjacent to both the lid cover 11 and the sleeve body

11.

In one example where the opening 13; 13’ is formed between the lid cover 11 and the sleeve body 10, the set of electronics 12 can be inserted in the direction transverse to the longitudinal axis L (as shown with arrow A1 ) into the opening 13 and thus be at least partially positioned between the lid cover and the sleeve body, as shown in Fig. 5 and Fig. 10B. Alternatively, in one example where the lid cover 1 T and the sleeve body 10’ are two independent components and be configured to be attached to one another to form the distal lid, the set of electronics 12’ can be axially placed between the lid cover and the sleeve body, as shown in Fig. 6 with arrow A2.

In one example where the opening 13’ is formed between the lid cover 11 and the sleeve body 10, the opening 13’ defines a channel. In one example, the channel comprises at least two chambers. One chamber is configured to receive the battery 12T and the other chamber is configured to receive the circuit and the switch.

The switch 122 is configured to be altered between a second state where the circuit 120 is in a working mode and a first state where the circuit 120 is in a low-power mode. In one example, the circuit 120 is electrically connected to the battery in the working mode and disconnected from the battery in the low-power mode. In this example, the cost of the medicament delivery device comprises the distal lid as disclosed in this description can be reduced. As the battery will only be used when the switch is triggered by the indicator 3 of the medicament delivery device so that the cost of the battery can be reduced. Furthermore, the battery can be small in this case, thus, the medicament delivery device can be compact. Alternatively, the circuit 120 is electrically connected to the battery in the working mode and in the low-power mode; in this example, the circuit is configured to consume less electrical energy in the low-power mode compared to the working mode. Therefore, none of, or major functions of, the circuit cannot be provided when the circuit is in the low-power mode. In this example, the circuit is ‘standby’ or ‘idle’ in the low-power mode. In this example, the circuit can provide different functions in low-power mode and the working mode. For example, the circuit is arranged with a timer and/or a temperature sensor for continuously recording time and temperature even if the circuit is in the low-power mode. The circuit further provides a visual and/or audible indication to the user and sends out signal to a remote device, e.g., personal devices and/or cloud, once the circuit is in the working mode. In this example, not only the use of the medicament delivery device can be recorded, the condition of this medicament delivery device, e.g., the storage temperature and/or the storage period, can also be recorded. The switch 122 is aligned with the central cavity 101 of the sleeve body in the direction of the longitudinal axis L, as shown in Fig. 2, such that the switch 122 is configured to be altered from the first state to the second state by the movable indicator 3 when the movable indicator 3 of the medicament delivery device moves towards the lid cover 11 ; 1 T.

The distal lid 1 as disclosed is configured to be used with a medicament delivery device comprising the movable indicator 3 that is axially movable in the distal end of the sleeve body 10; 10’; in other words, the movable indicator 3 is axially movable towards the lid cover. The movable indicator 3 can move linearly towards the lid cover 11; 1 T, or can move helically towards the lid cover; or can moves diagonally towards the lid cover.

In one example, the circuit 120 is electrically connected to the battery via the switch when the switch is in the second state. The electrical connection between the circuit 120 and the battery 121 is interrupted when the switch is in the first state. For example, the switch comprises a part that is made of a conductive material; in this example, the conductive part of the switch is configured to bridge the connection between the battery 121 the circuit 120 when the switch is in the second state and is configured to move away from the circuit when the switch is in the first state so that the connection between the battery and the circuit is interrupted.

In another example, the switch 122; 122’ is a mechanical switch configured to be in contact with the movable indicator 3 of the medicament delivery device such that the switch 122; 122’ is altered to the second state when the switch is in contact with the movable indicator 3 of the medicament delivery device. For example, the switch 122’ is configured to be pushed by the movable indicator 3 of the medicament delivery device in the distal direction of the sleeve body 10. In this example, the set of electronics comprises a biasing member to bias the switch towards the proximal end of the housing of the medicament delivery device so that the switch is in the first state. In one example, the switch is a switch pin. In one example, the movable indicator 3 is configured to move towards the distal end of the housing, when the medicament delivery operation is completed, for example. When the movable indicator 3 is contact the switch and followed by moves the switch against the force of the biasing member, the switch thus is moved to the second state by the movable indicator. In one example, the circuit is now in working mode, as a result, a unique ID and elapsed time (starts counting when the circuit is in the working mode) can be transmit to a remote device, e.g., a personal device that is close to the medicament delivery device or a cloud server. Furthermore, at least one of the visual, audible and tactile indication can be provided to user. For example, the medicament delivery device might need to be held against the medicament delivery site for 5-10 seconds after the medicament delivery operation is completed, in this example, the at least one of the visual, audible and tactile indication can be provided the indication to guide the user for receiving the sufficient dose from the medicament delivery device.

In another example, the switch is configured to be in contact with the movable indicator of the medicament delivery device to close a loop that comprises the circuit and the battery. Alternatively, the switch is configured to be pushed by the movable indicator of the medicament delivery device in the distal direction of the sleeve body to close a loop that comprises the circuit and the battery.

Alternatively, the switch a non-contact switch such that the switch is configured to be altered to the second state when the movable indicator 3 of the medicament delivery device moves towards the switch with a predetermined distance. For example, the switch is a reed switch and the movable indicator 3 comprises a magnet. Alternatively, the switch comprises a proximity sensor, e.g., an optical mouse sensor or an infra-red sensor, and a processor. The processor is configured to turn the circuit from the low-power mode to the working mode when the proximity of the movable indicator 3 is detected.

In one example, the circuit 120 is connected to at least one of a microprocessor, a data transmitter, a data receiver, a buzzer, a light emitter, a vibration motor, a memory, and a sensor. In a preferred example, the circuit is connected to a data transmitter and a light emitter. In this example, when the switch is in the second state, a signal can be sent by the circuit, e.g., preferably, a wireless signal to a smart device and/or a cloud database, and a light indication can be provided to the user.

In one example where the sleeve body 10 comprises the flexible arm 103 and/or the flexible portion 102, and the circuit comprises a sensor, the sensor can be used to detect a change in the status of the flexible arm 103 and/or the flexible portion 102, e.g., by detecting vibration and/or mechanical click sounds. As the flexible arm 103 is configured to be engaged with the plunger rod 6 of the medicament delivery device, the status of the plunger rod 6 can be detected, e.g., that the plunger rod is released and/or information about the progress of the medicament delivery operation. Similarly, as the flexible portion 102 is in contact with the medicament container, a status that is mechanically related to the medicament container can be detected. For example, when the medicament container is a syringe, when a needle of the syringe is penetrated an injection site, the reaction force from the injection site can be transferred to the syringe and the flexible portion, and thus the sensor can be used to detect a needle insertion.

In one example, the distal lid is assembled with that following steps in the following order:

• providing a sleeve body and a lid cover, wherein the sleeve body is integral to the lid cover; an opening is formed between the sleeve body and the lid cover, the opening is open in the direction transverse to the longitudinal axis;

• providing a set of electronics; and

• inserting the set of electronics from the opening.

In another example, the distal lid is assembled with following steps in the following order:

• providing a sleeve body;

• providing a lid cover;

• providing a set of electronics;

• placing the set of electronics on the sleeve body; and

• attaching the lid cover to the sleeve body to sandwich the set of electronics between the lid cover and the sleeve body.

It should be noted that the set of electronics can be glued to the sleeve body and/or the lid cover; or the set of electronics can be clamped between the sleeve body and the lid cover. Furthermore, the electronics can be placed on a PCB or can be received with an outer case, e.g., a plastic case.

Furthermore, in a preferred example, the medicament delivery device is assembled with following steps in the following order:

• providing a front assembly comprising a housing, a cap and optionally a delivery member guard;

• providing a power pack comprising a plunger rod, a plunger rod spring and a set of components that releasably hold the plunger rod;

• providing a medicament container;

• providing the distal lid;

• inserting a medicament container into the housing from the distal end of the housing;

• inserting the powerpack from the distal end of the housing; and attaching the distal lid to the distal end of the housing to cover the distal end of the housing.

Another aspect of the disclosure provides a sub-assembly of the medicament delivery device. The sub-assembly comprises the distal lid as mentioned above. The sub-assembly further comprises an indicator 3 movable within the central cavity 101 of the sleeve body 10. The indicator 3 comprises a proximally directed surface 32. A compression spring 4 is compressible between a proximal end and a distal end that is engaged with the proximally directed surface 32 of the indicator 3. A retaining mechanism is configured to releasably hold the indicator 3 against the force from the compression spring 4, as shown in Fig. 9A.

In one example, the sub-assembly comprises the plunger rod 6 of the medicament delivery device. The plunger rod 6 comprises a distally directed surface 61 engaged with the proximal end of the compression spring 4, as shown in Fig. 9A. In one example, the plunger rod 6 comprises a hollow body 60 so that the compression spring 4 is positioned within the hollow body 60 of the plunger rod 6. Furthermore, the sub-assembly optionally comprises a guide rod 5 positioned within the compression spring 4. The guide rod is configured to support the compression spring 4 to prevent the compression spring 4 from buckling. In one example, the distal end of the spring is directly engaged with the guide rod, and the guide rod is directly engaged with the proximally directed surface 32 of the indicator 3, as shown in Fig.

9. Alternatively, the guide rod is fully positioned within the compression spring. In another example, the indicator is at least partially positioned within the compression spring; therefore, the function of the guide rod can be provided by the indicator.

Alternatively, the sub-assembly comprises a delivery member guard comprising a distally directed surface engaged with the proximal end of the compression spring. The delivery member guard is configured to cover the medicament delivery member of the medicament delivery device. The delivery member guard is telescopically arranged within the housing of the medicament delivery device. The delivery member guard is configured to be biased in the proximal direction relative to the sleeve body by the compression spring.

In one example, the retaining mechanism is configured to releasably hold the indicator 3 against the force from the compression spring until an end of a medicament delivery operation of the medicament delivery device. In one example, the retaining mechanism comprises the plunger rod 6 of the medicament delivery device. In this example, the plunger rod 6 is at least partially arranged within the central cavity 101 of the sleeve body 10 before the end of the medicament delivery operation. The indicator 3 comprises a flexible arm 30 extending between the sleeve body 10 and the plunger rod 6, as shown in Fig. 9A. The flexible arm 30 comprises a proximally extending protrusion 31 bevelled to the longitudinal axis L. The protrusion 31 is supported by the plunger rod 6 to engage with a proximal end edge 104 of the sleeve body 10 when the plunger rod 6 is received within the central cavity 101 of the sleeve body 10. In this example, when the plunger rod 6 is positioned within the central cavity 101 of the sleeve body 10, the plunger rod blocks the flexible arm 30 of the indicator 3 from flexing radially towards the longitudinal axis L; therefore, the protrusion 31 engages with the proximal end edge 104 of the sleeve body 10, thus, the indicator 3 is prevented from moving in the distal direction relative to the sleeve body 10. In this example, the compression spring 4 is engaged with the proximally directed surface 32 of the indicator 3 at the distal end of the compression spring 4, and is engaged with the distally directed surface 61 of the plunger rod 6 at the proximal end of the compression spring 4. When the medicament delivery operation is carried out, the plunger rod 6 moves in the proximal direction relative to the sleeve body 10 under the force of the compression spring 4. The end of the medicament delivery operation is designed to be the position that the plunger rod 6 moves out of the central cavity 101 of the sleeve body 10. Once the plunger rod 6 moves out of the central cavity 101 of the sleeve body 10, the plunger rod 6 cannot block the flexible arm 30 of the indicator 3 from flexing radially towards the longitudinal axis L. Therefore, as the proximally extending protrusion 31 is bevelled to the longitudinal axis L and engaged with the proximal end edge 104 of the sleeve body 10, the spring force applied on the indicator 3 causes the flexible arm 30 of the indicator 3 to flex radially towards the longitudinal axis L, and the proximally extending protrusion 31 , therefore, disengages from the proximal end edge 104 of the sleeve body 10. Thus, the compression spring 4 moves the indicator s towards the lid cover 11 ; 1 T to alter the switch from the first state to the second state.

It should be noted that in one example where the sleeve body 10 comprises the flexible portion 102, the flexible portion 102 extends from the proximal end edge 104 of the sleeve body 10 in the proximal direction relative to the sleeve body 10.

Alternatively, the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring before the plunger rod is released to carry out a medicament delivery operation. For example, a safety pin can be inserted into the sleeve body to block the distal movement of the indicator. When the user plans to use the device, the user can remove the safety pin, thus, the indicator can be pushed towards the lid cover to alter the switch from the first state to the second state. In one example, the indicator is pushed towards the lid cover by the compression spring, e.g., the compression spring is connected to the plunger rod or the compression spring is connected to the delivery member guard, as mentioned above.

Furthermore, the housing of the medicament delivery device, and/or the carrier, 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.

Some aspects of the invention are defined by the following clauses.

1. A distal lid (1 ) of a medicament delivery device, wherein the distal lid (1 ) is configured to cover a distal end of a housing (2) of the medicament delivery device, the distal lid (1 ) comprising: a sleeve body (10; 10’) extending along a longitudinal axis (L) between a proximal end and a distal end; wherein the sleeve body (10; 10’) comprises a central cavity (101) configured to receive a movable indicator (3) of the medicament delivery device; a lid cover (11 ; 11’) extending from the distal end of the sleeve body (10; 10’) in a direction transverse to the longitudinal axis (L); a set of electronics (12; 12’) comprising a battery (121 ), a circuit (120) and a switch (122; 122’) electrically connected to the battery (121 ) and the circuit (120); wherein the set of electronics (12; 12’) is at least partially positioned between the lid cover (11 ; 11’) and the sleeve body (10) in the direction of the longitudinal axis (L); wherein the switch (122; 122’) is configured to be altered between a first state where the circuit (120) is in a low-power mode and a second state where the circuit (120) is in a working mode; and wherein the switch (122; 122’) is aligned with the central cavity (101 ) of the sleeve body in the direction of the longitudinal axis (L) such that the switch (122; 122’) is configured to be altered, by the movable indicator (3), from the first state to the second state when the movable indicator (3) of the medicament delivery device moves towards the lid cover (11 ; 1 T).

2. The distal lid according to clause 1 , wherein the sleeve body is configured to be at least partially inserted into the distal end of the housing of the medicament delivery device.

3. The distal lid according to clause 1 or 2, wherein the lid cover is integral to the sleeve body. 4. The distal lid according to clause 1 or 2, wherein the lid cover is attached to the sleeve body via at least one of a snap-fit, a press-fit, a screw or a bayonet fixture.

5. The distal lid according to any of the preceding clauses, wherein an opening is formed between the lid cover and the sleeve body; and wherein the opening is open in the direction transverse to the longitudinal axis.

6. The distal lid according to any of the preceding clauses, wherein the sleeve body comprises a flexible arm defined by two cut-outs in a wall of the sleeve body; wherein a protrusion extends from the flexible arm in the direction transverse to the longitudinal axis; and wherein the protrusion is configured to releasably engage with a plunger rod of the medicament delivery device.

7. The distal lid according to any of the preceding clauses, wherein the sleeve body comprises a flexible portion extending from the proximal end of the sleeve body; wherein the flexible portion is compressible in the direction of the longitudinal axis; and wherein the flexible portion is configured to be in contact with a medicament container of the medicament delivery device.

8. The distal lid according to clause 7, wherein the flexible portion is a plastic spring.

9. The distal lid according to clause 7, wherein the flexible portion is a proximally extending flexible arm.

10. The distal lid according to any of the preceding clauses, wherein the circuit is electrically connected to the battery via the switch when the switch is in the second state; and wherein the electrical connection between the circuit and the battery is interrupted when the switch is in the first state.

11. The distal lid according to any of the preceding clauses, wherein the switch is a mechanical switch configured to be in contact with the movable indicator of the medicament delivery device such that the switch is altered to the second state when the switch is in contact with the movable indicator of the medicament delivery device.

12. The distal lid according to clause 11 , wherein the switch is configured to be pushed by the movable indicator of the medicament delivery device in the distal direction relative to the sleeve body. 13. The distal lid according to a combination of clauses 10 and 11 , wherein the switch is configured to be in contact with the movable indicator of the medicament delivery device to close a loop that comprises the circuit and the battery.

14. The distal lid according to a combination of clauses 10 and 12, wherein the switch is configured to be pushed by the movable indicator of the medicament delivery device in the distal direction relative to the sleeve body to close a loop that comprises the circuit and the battery.

15. The distal lid according to any of the preceding clauses, wherein the switch is a noncontact switch such that the switch is configured to be altered to the second state when the movable indicator of the medicament delivery device moves towards the switch by a predetermined distance.

16. The distal lid according to any of the preceding clauses, wherein the circuit is connected to at least one of a microprocessor, a data transmitter, a data receiver, a buzzer, a light emitter, a vibration motor, a memory and a sensor.

17. A sub-assembly of the medicament delivery device, the sub-assembly comprising: the distal lid according to any of the preceding clauses; an indicator movable within the central cavity of the sleeve body; wherein the indicator comprises a proximally directed surface; a compression spring extending between a proximal end and a distal end that is engaged with the proximally directed surface of the indicator; and a retaining mechanism configured to releasably hold the indicator against the force from the compression spring.

18. The sub-assembly according to clause 17, wherein the sub-assembly comprises a plunger rod comprising a distally directed surface engaged with the proximal end of the compression spring.

19. The sub-assembly according to clause 17, wherein the sub-assembly comprises a delivery member guard comprising a distally directed surface engaged with the proximal end of the compression spring.

20. The sub-assembly according to any of clauses 17-19, wherein the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring until an end of a medicament delivery operation of the medicament delivery device. The sub-assembly according to clause 20 when dependent on clause 18, wherein the retaining mechanism comprises the plunger rod; wherein the plunger rod is at least partially arranged within the central cavity of the sleeve body before the end of the medicament delivery operation; wherein the indicator comprises a flexible arm extending between the sleeve body and the plunger rod; and wherein the flexible arm comprises a proximally extending protrusion bevelled relative to the longitudinal axis; and wherein the flexible arm is blocked by the plunger rod from flexing towards the longitudinal axis such that the proximal extending protrusion is engaged with a proximal end edge of the sleeve body when the plunger rod is received within the central cavity of the sleeve body. The sub-assembly according to any of clauses 17-19, wherein the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring before the plunger rod is released to carry out a medicament delivery operation.

Claims

1. A distal lid (1 ) of a medicament delivery device, wherein the distal lid (1 ) is configured to cover a distal end of a housing (2) of the medicament delivery device, the distal lid (1 ) comprising: a sleeve body (10; 10’) extending along a longitudinal axis (L) between a proximal end and a distal end; wherein the sleeve body (10; 10’) comprises a central cavity (101) configured to receive a movable indicator (3) of the medicament delivery device; a lid cover (11 ; 11’) extending from the distal end of the sleeve body (10; 10’) in a direction transverse to the longitudinal axis (L); a set of electronics (12; 12’) comprising a battery (121 ), a circuit (120) and a switch (122; 122’) electrically connected to the battery (121 ) and the circuit (120); wherein the set of electronics (12; 12’) is at least partially positioned between the lid cover (11 ; 11’) and the sleeve body (10) in the direction of the longitudinal axis (L); wherein the switch (122; 122’) is configured to be altered between a first state where the circuit (120) is in a low-power mode and a second state where the circuit (120) is in a working mode; and wherein the switch (122; 122’) is aligned with the central cavity (101 ) of the sleeve body in the direction of the longitudinal axis (L) such that the switch (122; 122’) is configured to be altered, by the movable indicator (3), from the first state to the second state when the movable indicator (3) of the medicament delivery device moves towards the lid cover (11 ; 11’).

2. The distal lid according to claim 1, wherein the sleeve body is configured to be at least partially inserted into the distal end of the housing of the medicament delivery device.

3. The distal lid according to claim 1 or 2, wherein the lid cover is integral to the sleeve body.

4. The distal lid according to claim 1 or 2, wherein the lid cover is attached to the sleeve body via at least one of a snap-fit, a press-fit, a screw or a bayonet fixture.

5. The distal lid according to any of the preceding claims, wherein an opening is formed between the lid cover and the sleeve body; and wherein the opening is open in the direction transverse to the longitudinal axis.

6. The distal lid according to any of the preceding claims, wherein the sleeve body comprises a flexible portion extending from the proximal end of the sleeve body; wherein the flexible portion is compressible in the direction of the longitudinal axis; and wherein the flexible portion is configured to be in contact with a medicament container of the medicament delivery device.

7. The distal lid according to any of the preceding claims, wherein the circuit is electrically connected to the battery via the switch when the switch is in the second state; and wherein the electrical connection between the circuit and the battery is interrupted when the switch is in the first state.

8. The distal lid according to any of the preceding claims, wherein the switch is a mechanical switch configured to be in contact with the movable indicator of the medicament delivery device such that the switch is altered to the second state when the switch is in contact with the movable indicator of the medicament delivery device.

9. The distal lid according to claim 8, wherein the switch is configured to be pushed by the movable indicator of the medicament delivery device in the distal direction relative to the sleeve body.

10. The distal lid according to a combination of claims 7 and 8, wherein the switch is configured to be in contact with the movable indicator of the medicament delivery device to close a loop that comprises the circuit and the battery.

11. A sub-assembly of the medicament delivery device, the sub-assembly comprising: the distal lid according to any of the preceding claims; an indicator movable within the central cavity of the sleeve body; wherein the indicator comprises a proximally directed surface; a compression spring extending between a proximal end and a distal end that is engaged with the proximally directed surface of the indicator; and a retaining mechanism configured to releasably hold the indicator against the force from the compression spring.

12. The sub-assembly according to claim 11, wherein the sub-assembly comprises a plunger rod comprising a distally directed surface engaged with the proximal end of the compression spring.

13. The sub-assembly according to any of claims 11 or 12, wherein the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring until an end of a medicament delivery operation of the medicament delivery device. The sub-assembly according to a combination of claim 12 and 13, wherein the retaining mechanism comprises the plunger rod; wherein the plunger rod is at least partially arranged within the central cavity of the sleeve body before the end of the medicament delivery operation; wherein the indicator comprises a flexible arm extending between the sleeve body and the plunger rod; and wherein the flexible arm comprises a proximally extending protrusion bevelled relative to the longitudinal axis; and wherein the flexible arm is blocked by the plunger rod from flexing towards the longitudinal axis such that the proximal extending protrusion is engaged with a proximal end edge of the sleeve body when the plunger rod is received within the central cavity of the sleeve body. The sub-assembly according to any of claims 11-14, wherein the retaining mechanism is configured to releasably hold the indicator against the force from the compression spring before the plunger rod is released to carry out a medicament delivery operation.