WO2025073511A1 - A monitoring unit for a medicament delivery device - Google Patents

Abstract

A monitoring unit (200) is releasably attachable to a medicament delivery device (100). The medicament delivery device (100) includes at least one electrically conductive component (102). The monitoring unit comprises: an inductive sensor (201) configured to sense a position status of the electrically conductive component (102) during an injection process based on magnetic flux, MF, changes caused by displacement of the electrically conductive component (102). The electrically conductive component (102) may be, for example, (i) a metallic injection spring of the medicament delivery device (100), or (ii) comprised in a needle cap of the medicament delivery device (100), or (iii) a needle shield spring (102b) of the medicament delivery device (100).

Description

A MONITORING UNIT FOR A MEDICAMENT DELIVERY DEVICE

TECHNICAL FIELD

The present invention relates to a monitoring unit releasably attachable to a medicament delivery device, a medicament delivery device and a kit comprising a medicament delivery device.

BACKGROUND OF THE INVENTION

There are a number of medicament delivery devices that have been developed for selfadministration of a medicament by a patient who is usually a non-medically trained person.

For many treatments, like asthma, diabetes, hormone growth, the patient has to receive doses on a regular basis and the advantage with such devices is that the patient can administer the delivery anywhere and is not bound to visit care facilities in order to receive medication.

However, there are also many patients or elderly with motor skills difficulties and who could have problems with the correct and safe handling of the medicament delivery devices. In addition, accidental needle injuries and transferring an incorrect amount of medication are always a concern. Therefore, it is beneficial if the risks of wrong handling of the device are minimized so that the patient does not receive a wrong dosage amount.

There is therefore an increasing demand for the tracking and monitoring activation of medicament delivery device in a reliable and consistent manner.

SUMMARY

An aim of the present invention is to provide a monitoring unit releasably attachable to a medicament delivery device for tracking and monitoring activation of medicament delivery device in a reliable and consistent manner to increase patient safety.

This aim is achieved by the features of the claims. Preferred embodiments of the invention are defined in the dependent claims. According to the present invention, a monitoring unit is releasably attachable to a medicament delivery device, wherein the medicament delivery device includes at least one resilient and electrically conductive component, the monitoring unit comprising: an inductive sensor configured to sense a position status of the electrically conductive component during an injection process based on magnetic flux, MF, changes caused by displacement of the resilient and electrically conductive component, wherein the resilient and electrically conductive component is a metallic injection spring of the medicament delivery device that is in a tensioned state at a guarding position and in a relaxed state at an actuating position.

According to the present invention, a monitoring unit is releasably attachable to a medicament delivery device, wherein the medicament delivery device includes at least one electrically conductive component, the monitoring unit comprising: an inductive sensor configured to sense a position status of the electrically conductive component during an injection process based on magnetic flux, MF, changes caused by displacement of the electrically conductive component, wherein the electrically conductive component is comprised in a needle cap of the medicament delivery device.

According to the present invention, a monitoring unit is releasably attachable to a medicament delivery device, wherein the medicament delivery device includes at least one resilient and electrically conductive component, the monitoring unit comprising: an inductive sensor configured to sense a position status of the electrically conductive component during an injection process based on magnetic flux, MF, changes caused by displacement of the resilient and electrically conductive component, wherein the resilient and electrically conductive component is a needle shield spring of the medicament delivery device that is configured to bias movement of a needle shield.

The inductive sensor may comprise: at least one inductor coil configured to generate a magnetic field on the electrically conductive component; a sensor circuit configured to detect density of magnetic flux, MF, flowing in the electrically conductive component; a computing component configured to correlate the detected magnetic flux density flowing in the electrically conductive component to the density of the electrically conductive component to determine the position status of the electrically conductive component. Based on the MF changes caused by the displacement of the needle shield spring, the computing component may be configured to determine (i) how far the needle shield spring is pressed down, and/or (ii) if the needle shield spring was kept down for the whole injection process, and/or (iii) if the needle shield spring extends back out fully after the injection process.

Based on the MF changes caused by the displacement of the metallic injection spring, the computing component may be configured to (i) calculate a speed of expansion of the metallic injection spring to determine an injection speed of the medicament delivery device, and/or (ii) determine a start and an end motion of the metallic injection spring, and/or (iii) determine if the injection spring is expanded to an expected maximum range.

The inductor coil may be a plurality of inductor coils configured to generate different strength of magnetic field on the electrically conductive component in the medicament delivery device.

The monitoring unit further comprises at least one of a transceiver, an accelerometer, a vibration sensor, an acoustic sensor, ultrasonic sensor, temperature sensor and an optical sensor. The monitoring device may be configured to respectively detect at least one of an electronic signal, a mechanical vibration, acoustical sound pressure, acoustic wave, ultrasonic wave, light wave, optical signal, orientation, temperature measurement and acceleration signals of an injection process event.

The inductive sensor may be configured to further sense a position status of a secondary electrically conductive component disposed around a needle of the medicament delivery device.

The temperature sensor may be configured to measure a temperature of the injection device and/or drug comprised in the medicament delivery device. The computing component may be configured to track the measured temperature and provide an acoustic signal when the measured temperature exceeds a predetermined temperature range.

The monitoring unit may further comprise a magnetic shield element configured to shield the inductive sensor against external magnetic sources. The monitoring unit may be releasably attachable to a distal end of the medicament delivery device.

The monitoring unit may be releasably attachable to a proximal end of the medicament delivery device.

The monitoring unit may be in plurality and one or more monitoring units is releasably attachable to the distal end or the proximal end of the medicament delivery device.

The one or more monitoring units may be releasably attachable to a housing of the medicament delivery device.

A kit comprising a medicament delivery device and a monitoring unit.

A medicament delivery device comprising: a housing; a power pack arranged within the housing and comprising a drive spring; a needle shield and a needle shield spring; a needle cap; and at least one monitoring unit.

The medicament delivery device may further comprise: one or more sensing coils embedded in a proximal end and/or a distal end of the housing.

BRIEF DESCRIPTION OF DRAWINGS

In the following detailed description of the invention, reference will be made to the accompanying drawings.

Fig. 1A is a graph recording data of an injection process.

Fig. IB shows a nominal workflow process.

Fig. 2 shows a monitoring unit and some of its components.

Fig. 3 shows a monitoring unit releasably attached to a distal end of the medicament delivery device. Fig. 4 shows a monitoring unit releasably attached to a proximal end of the medicament delivery device.

Figs. 5 and 6 show a monitoring unit releasably attached to a distal end of another medicament delivery device, at the beginning and end of the medicament delivery process respectively.

Fig. 7 shows a graph of inductance against extension of a metallic drive spring of a medicament delivery device.

Fig. 8 shows a monitoring unit releasably attached to a proximal end of yet another medicament delivery device.

DETAILED DESCRIPTION OF THE INVENTION

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.

An example of tracking and monitoring activation of autoinjectors involves leveraging a tool such as DOSE™, e.g. as described in WO2018/158270, to monitor the commencement and conclusion of an injection procedure. This is achieved by detecting the vibrational disturbances produced by the actuation of the click mechanism inherent to the medicament delivery device (autoinjector).

Method such as this have proven to be effective. As demonstrated in the graph provided in Fig. 1, the recorded data can render a distinct, easily interpreted visualization of the injection process. The primary limitation of this method lies in its capacity to distinguish between vibrations instigated by the internal triggering of the medicament delivery device and those due to external factors such as accidental taps and knocks that the device may encounter during regular storage and transportation. Although there exists the potential to incorporate advance Machine Learning Techniques to train the system in differentiating and categorizing distinct types of signals, this approach can be further refined and improved.

With application of standard machine learning techniques, it is possible to further train the system in differentiating and categorizing distinct types of signals, this approach could be further refined to identify secondary events of interest such as cap removal and post injection dwell times.

A nominal workflow processing is shown in Fig. IB.

Filtering nominally consists transforming X, Y & Z sensor data (captured at ~3000Hz) into simple magnitude vector signals that are then passed through low pass filters, for example using the following equations:

Events of interest are separated by areas of low or zero activity after filtering.

Final event classification can range from simple threshold cutoff to more elaborate frequency or time domain analysis to generate various secondary signals that can be used as inputs for more advanced Machine learning based pattern matching.

Another solution is to amalgamate the vibration data with alternative signal sources, which is the primary objective of the present invention.

While DOSE integrates data derived from accelerometer and optical sensors, the proposed alteration involves combining accelerometer data with readings from inductive sensing coils. These coils may be effortlessly integrated into the mounting sleeve or clip, ensuring the device remains fully removable and does not cause any mechanical changes or alterations to the autoinjector itself. Through the use of a standard Inductance to Digital Converter (IDC) chip and bespoke sensing coils designed on a flexible printed circuit board (PCB), it is feasible to detect changes in the expansion of the internal metal springs housed within the autoinjector.

WO 2018/069150 Al by Keller et al. describes a related process related to the measurement of changes in induction of the spring, however, it necessitates physical modifications to the autoinjector as they outline a method that requires electrical contact with the internal spring. The method proposed here is distinctively different as it is based on completely external sensing, requiring no alterations to the autoinjector itself. This concept is universally applicable to any autoinjector that contains an extending spring or any other internal movable metallic component.

The proposed design is configured in such a way that the sensing coils are wholly incorporated within the mounting sleeve, which leads to a more compact electronic design.

While one could argue that the use of multiple sensing coils tracking induction changes alone may be sufficient to monitor activation of the medicament delivery device, ultimate reliability is achieved by the fusion of multiple independent sensor inputs - both inductive and vibrational. This dual-sensor arrangement introduces redundancy into the system, bolstering confidence in the detection accuracy. The cross-verification of data from these separate sensors provides an additional layer of assurance, validating that the activation events registered are indeed authentic.

Fig. 2 shows a monitoring unit 200 of the present invention for tracking and monitoring the injection process event of a medicament delivery device. The monitoring unit 200 comprises an inductive sensor 201 and a transceiver 202. The inductive sensor 201 includes at least one inductor coil 201a, sensor circuit 201b and a computing component 201c. The transceiver 202 includes a receiver 202a and a transmitter 202b.

The monitoring unit 200 may be used to monitor a position status of an electrically conductive component 102 during an injection process based on magnetic flux (MF) changes caused by movement or displacement of the electrically conductive component 102, e.g. expansion of a metallic injection spring 102a. The electrically conductive component 102 is at least partially made of electrically conductive material permitting the flow of alternating current that produce an alternating magnetic field of sufficient intensity that can be detected by the inductive sensor 201 (or the sensor circuit 201b). The alternating current in the inductor coil 201a generates an alternating magnetic field (or electromagnetic field) on the electrically conductive component 102 to induce eddy current on the electrically conductive component 102. The inductive sensor 201 (or sensor circuit 201b) senses an initial, intermediate, and final values and/or density differences in the alternating magnetic field or magnetic flux in the electrically conductive component 102. Magnetic flux density is a measurement of the magnetic field lines. The magnetic field or magnetic flux differences are caused by movement or displacement of the electrically conductive component 102.

Referring to Fig. 3, in one embodiment the electrically conductive component 102 is a metallic injection spring 102a of the medicament delivery device 100 that is in a tensioned state at an initial position and in a relaxed state after delivery of the medicament from the medicament delivery device 100. When the inductive sensor 201 senses a high magnetic flux density, the metallic injection spring 102a is at the initial position (as shown in Fig. 4), in which it is fully compressed. When the inductive sensor 201 senses a low magnetic flux density, the metallic injection spring 102a is at a final position (as shown in Fig. 3), in which it is in a relaxed state. Fig. 7 shows variation in inductance in the sensor circuit 201b (line A) against extension of the metallic injection spring 102a. Line B in Figure 7 is an output, which is inversely proportional to the inductance and hence increases with extension of the metallic injection spring 102a, even if not directly proportionally

The computing component 201c may correlate the detected magnetic flux density flowing in the electrically conductive component 102 to the density of the electrically conductive component 102 to determine the position status of the electrically conductive component 102. The computing component 201c may correlate the detected magnetic flux density to a certain position status of the electrically conductive component 102 via application of machine learning techniques or via a preconfigured parameters list or from a database. The information data derived from the detected magnetic flux density and the determined position status may be stored in a memory of the computing component 201c. Based on the initial, any intermediate, and final values and/or density differences in the alternating magnetic field or magnetic flux flowing in the electrically conductive component 102, the position status of the electrically conductive component 102 can be derived and/or motion of the electrically conductive component 102 can be inferred. For example, the speed of expansion of the metallic injection spring 102a can be calculated which gives an indication of the drug injection speed, and/or the start and end motion of the injection spring can be detected, which gives an indication of the actual volume of the medicament dosage that was delivered. The monitoring unit 200 is also able to determine if metallic injection spring 102a is expanded to its expected maximum state. If it is determined that the metallic injection spring 102a is not expanded to its expected maximum range, this gives an indication that the full medicament dosage was not properly delivered. Such scenarios may occur when the patient lifts the medicament delivery device 100 earlier than intended, or there was a jam in the medicament delivery device 100 during the injection process.

The monitoring unit 200 may also be used for detecting the absence or presence of the needle cap 102c of the medicament delivery device 100 (see, e.g., Fig. 8). The electrically conductive component 102 in this case is comprised in a needle cap 102c of the medicament delivery device 100. This might be a dedicated component added to the needle cap 102c to facilitate detection. Alternatively, it may be the Rigid Needle Sheild (RNS) mounted within the needle cap 102c. Based on the detection of the magnetic flux density (or changes) of the needle cap 102c, it is possible to detect the removal of the needle cap 102c.

The monitoring unit 200 may also be used for monitoring the needle shield spring 102b. In the embodiments shown in Figs. 3 and 4, the needle shield spring 102b is at the proximal end of the medicament delivery device 100. In the embodiment shown in Figs. 5 and 6, the needle shield spring 102b is at the distal end of the medicament delivery device 100. The inductor coil or coils 201a are positioned on the medicament delivery device 100 at the same end, or in a similar location, to the need shield spring 102b in the respective embodiments, so at the proximal end in the embodiment shown in Fig. 3 and at the distal end in the embodiment shown in Figs. 5 and 6. Notably, in the embodiment shown in Figs. 5 and 6, the monitoring unit 200 has two inductor coils, one for monitoring the position status of the metallic drive spring 102a and one for monitoring the position status of the needle shield spring. Based on the detection of the magnetic flux changes of the needle shield spring 102b, it is possible to detect the position status of the needle shield spring 102b, for example, (i) how far the needle shield spring 102b was pressed down, (ii) if it was kept down for the whole injection process and (iii) if it extends back out fully after an injection.

The inductor coil 201a may be a plurality of inductors coils that generate different strength of magnetic field on the electrically conductive component 102 in the medicament delivery device 100.

The use of multiple sensor inputs may increase the accuracy of the tracking and monitoring of the medicament delivery device 100. For example, variation in temperature of the medicament could cause problem associated with viscosity of the medicament. Since certain medicament may exhibit higher viscosity at a lower temperature, this can make it difficult for a patient to selfadminister the medicament and the medicament delivery device 100 may also fail to deliver a full dose due to the higher viscosity of the medicament. Furthermore, since the changes in the viscosity of the medicament resulting from temperature variation may not be visible to the patient, the patient may not be aware of the ineffectiveness or harmful nature caused by such changes in medicament, for example decomposition. Any administration of such medicament could lead to serious detrimental consequence to the health of the patient. The monitoring device 200 may therefore also include a temperature sensor to track the temperature measurement of the medicament in the medicament delivery device 100.

In a preferred embodiment, the temperature sensor may be configured to measure a temperature of the container 104 and/or drug comprised in the medicament delivery device 100. The computing component 201c may be configured to track the measured temperature and provide an acoustic signal when the measured temperature exceeds a predetermined temperature range.

The monitoring device 200 may further include one or more of an accelerometer, a vibration sensor, an acoustic sensor, ultrasonic sensor, temperature sensor and an optical sensor. For example, an accelerometer for detecting acceleration signal of an injection process event may be used as a secondary confirmation. For example, such a component may be provided as part of the computing component 201c. The monitoring device 200 may be configured to further detect the respective signal of the sensor used, i.e., an electronic signal, a mechanical vibration, acoustical sound pressure, acoustic wave, ultrasonic wave, light wave, optical signal, orientation, temperature measurement and acceleration signals of an injection process event. Further, if there are secondary metal element around the needle of the medicament delivery device 100 that is configured to be retracted prior to an injection, it is also possible to use the inductive sensor or an appropriate sensor to track motion of said metal element as a secondary confirmation of a start of an injection event.

The monitoring device 200 may include one or more communication modules 202. In the illustrated embodiment a communication module 202 includes a short range, e.g. Bluetooth® or BLE®, communication module 202a and a mobile, e.g. 5G, communication module 202b. The transceiver 202 may transmit the collected/stored information data in the memory of the computing component 201c to a local mobile device and/or to a remote server that can be accessed by the patient or the doctor. This allows the doctor to determine the patient's compliance with the medicament regimen or for a patient to monitor his medicament intake on his mobile device.

The monitoring unit 200 may comprise a magnetic shield element to shield the inductive sensor 201 against external magnetic sources.

The monitoring unit 200 may be releasably attached to different parts of the medicament delivery device 100, for example a distal end or a proximal end. As illustrated in Figs. 3 and 4 and 6, the monitoring unit 200 may be releasably attached to the distal end of the medicament delivery device 100. As illustrated in Figs. 5, the monitoring unit 200 may be releasably attached to the distal end of the medicament delivery device 100. The present invention is not limited to a single monitoring unit 200 and more than one monitoring unit 200 may be releasably attached to a medicament delivery device 100. The one or more monitoring unit 200 may also be releasably attached to a housing of the medicament delivery device 100.

A medicament delivery device 100 according to the present invention includes a housing 101, a power pack arranged within the housing and comprising a drive spring, a needle shield 103 and a needle shield spring 102b, a needle cap, and at least one monitoring unit 200. The medicament delivery device may comprise one or more sensing coil 201a embedded in a proximal end and/or a distal end of the housing 101.

A kit according to the present invention includes a medicament delivery device 100 and a monitoring unit 200.

The medicament delivery devices 100 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 and/or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, 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 delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucosedependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet- derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD- 1/PD-L1) inhibitors/modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation wl37 (CDwl37) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6)/AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation wl23 (CDwl23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as 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.

Exemplary drugs that could be included in the delivery devices described herein include "generic" or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the "innovator" or "branded" version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant 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.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.

Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the 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. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

Exemplary drugs that could be included in the 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.

Claims

Claims

1. A monitoring unit (200) releasably attachable to a medicament delivery device (100), wherein the medicament delivery device (100) includes at least one electrically conductive component (102), the monitoring unit (200) comprising: an inductive sensor (201) configured to sense a position status of the electrically conductive component (102) based on magnetic flux, MF, changes resulting from movement of the electrically conductive component (102), wherein the electrically conductive component (102) is one of:

- a resilient component comprising a metallic injection spring (102a) of the medicament delivery device (100) that is in a tensioned state at a guarding position and in a relaxed state at an actuating position,

- a resilient component (102) comprising a needle shield spring (102b) of the medicament delivery device (100) that is configured to bias movement of a needle shield (103) of the medicament delivery device (100), or

- comprised in a needle cap of the medicament delivery device (100).

2. The monitoring unit (200) according to claim 1, wherein the inductive sensor (201) comprises: at least one inductor coil (201a) configured to generate a magnetic field in the vicinity of the electrically conductive component (102); a sensor circuit (201b) configured to detect changes in inductance resulting from the MF changes; a computing component (201c) configured to correlate the detected changes in inductance to the movement of the electrically conductive component (102) to determine the position status of the electrically conductive component (102).

3. The monitoring unit (200) according to claim 2, wherein the changes in inductance that the sensor circuit (201a) is configured to detect are changes in inductance of the inductor coil (201a).

4. The monitoring unit (200) according to claim 2 or claim 3, comprising one or more additional inductor coils at different positions and/or of different dimensions to the inductor coil (201a), wherein the sensor circuit (201b) is configured to detect changes in inductance in the additional inductor coil(s) resulting from the MF changes and the computing component (201c) is configured to correlate the detected changes in inductance in the inductor coil (201a) and the additional inductor coils to the movement of the electrically conductive component (102) to determine the position status of the electrically conductive component (102).

5. The monitoring unit (200) according to any one of the preceding claims, wherein the electrically conductive component (102) is the resilient component (102) comprising the needle shield spring (102b) and based on the MF changes caused by the displacement of the needle shield spring (102b), the inductive sensor (201) is configured to determine

(i) how far the needle shield spring (102b) is pressed down, and/or

(ii) if the needle shield spring (102b) was kept down for the whole injection process, and/or

(iii) if the needle shield spring (102b) extends back out fully after the injection process.

6. The monitoring unit (200) according to any one of claims 1 to 4, wherein the electrically conductive component (102) is the resilient component comprising the metallic injection spring (102a) and based on the MF changes caused by the displacement of the metallic injection spring (102a), the inductive sensor (201) is configured to

(i) calculate a speed of expansion of the metallic injection spring (102a) to determine an injection speed of the medicament delivery device (100), and/or

(ii) determine a start and an end motion of the metallic injection spring (102a), and/or

(iii) determine if the injection spring (102a) is expanded to an expected maximum range.

7. The monitoring unit (200) according to any one of the preceding claims, further comprising at least one of an accelerometer, a vibration sensor, an acoustic sensor, ultrasonic sensor, temperature sensor and an optical sensor, and wherein the monitoring unit (200) is configured to respectively detect at least one of an electronic signal, a mechanical vibration, acoustical sound pressure, acoustic wave, ultrasonic wave, light wave, optical signal, orientation, temperature measurement and acceleration signals of an injection process event.

8. The monitoring unit (200) according to any one of the preceding claims, wherein the inductive sensor (201) is configured to further sense a position status of a secondary electrically conductive component (102) disposed around a needle of the medicament delivery device (100).

9. The monitoring unit (200) according to any one of the preceding claims, further comprising a/the temperature sensor, the temperature sensor being configured to measure a temperature of an injection device and/or drug disposed in the medicament delivery device (100), wherein the computing component (201c) is configured to track the measured temperature and provide an acoustic signal when the measured temperature exceeds a predetermined temperature range.

10. The monitoring unit (200) according to any one of the preceding claims, further comprising a transceiver (202) that includes a wireless communication module configured to transmit the information to a server and/or a mobile device, preferably wherein the information is includes or is derived from the position status of the electrically conductive component (102).

11. The monitoring unit (200) according to any one of the preceding claims, further comprising a magnetic shield element configured to shield the inductive sensor (201) against external magnetic sources.

12. The monitoring unit (200) according to any one of claims 1 to 5, wherein the monitoring unit (200) is releasably attachable to a distal end of the medicament delivery device (100).

13. The monitoring unit (200) according to any one of claims 1 to 4 or 6, wherein the monitoring unit (200) is releasably attachable to a proximal end of the medicament delivery device (100).

14. A kit comprising a medicament delivery device (100) and a monitoring unit (200) according to any one of the preceding claims.

15. A medicament delivery device (100) comprising: at least one monitoring unit (200) according to any one of claims 1 to 16; a housing (101); a power pack arranged within the housing (101) and comprising the metallic injection spring (102a) ; the needle shield (103), the needle shield spring (102b); and the needle cap.