Medicament delivery device and method for operating a medicament delivery device

Abstract

The invention provides a medicament delivery device comprising a lead screw for driving a plunger for expelling a medicament, a motor for driving the lead screw, a control circuit for controlling the motor, and an image sensor for sensing movement of the lead screw when being driven by the motor The invention also provides a for controlling operation of a medicament delivery device.

Description

[0001] Medicament delivery device and method for operating a medicament delivery device

[0002] Technical area

[0003] The present invention relates to sensing operation of a medicament delivery device.

[0004] Background of Invention

[0005] There is an ever-increasing demand for obtaining information from different devices and apparatuses that we use daily, and medicament delivery devices are no exception to that demand. Because of this, a number of medicament delivery devices have been developed that contain "smart" features such as sensor and monitoring systems, communication circuits, manmachine interfaces that can present information regarding the status of the medicament delivery device, for instance.

[0006] One feature of particular interest in medicament delivery devices is to monitor the movement of components or elements of a drive unit, such as for example a plunger rod that is acting on a medicament container during delivery of a dose of medicament. However, since these components are arranged inside a housing of a medicament delivery device, access to them may be difficult without major modifications. WO 2017 / 071983 Al discloses a medicament delivery device comprising a housing, a power unit comprising an actuation element, which actuation element is operably arranged to move inside said housing for expelling a dose of medicament. The medicament delivery device further comprises a monitoring unit being detachably attached to said housing, and at least one sensor arranged in said monitoring unit. The at least one sensor is operably arranged to monitor the power unit for obtaining information regarding status of the medicament delivery device.

[0007] Brief Description of the Invention

[0008] The aim of the present invention is to remedy the drawbacks of the state of the art devices. This aim is obtained with a medicament delivery device according to the features of the independent claims. Preferable embodiments of the invention form the subject of the dependent claims. According to a first aspect, the invention provides a medicament delivery device comprising a lead screw for driving a plunger for expelling a medicament, a motor for driving the lead screw, a control circuit for controlling the motor, and an image sensor for sensing movement of the lead screw when being driven by the motor. The image sensor is preferably comprised in the control circuit.

[0009] According to a preferred aspect, the image sensor is configured to sense the thread pattern of the lead screw of the medicament delivery device. Preferably, the image sensor is configured to sense axial position shifts of at least one of the threads of the lead screw. The image sensor may preferably be configured to compare the sensed axial position shifts with a reference value or threshold value. The image sensor may further be configured to detect an abnormal behaviour of the lead screw if the sensed movement of the lead screw is at or below the reference value or threshold value.

[0010] In a preferred embodiment, the lead screw has a longitudinal axis. Preferably, the lead screw is axially moveable along its longitudinal axis. Further preferred is that the lead screw is non- rotatable, i.e., non-rotatably arranged in the medicament delivery device.

[0011] According to an alternative concept, the lead screw is rotatably arranged in the medicament delivery device. In this embodiment, the image sensor is configured to sense the rotation of the lead screw of the medicament delivery device.

[0012] The control circuit may be configured to control the motor depending on the result of the sensing of movement of the lead screw by the image sensor. Preferably, the control circuit is configured to control the power supply to the motor depending on the result of the sensing of movement of the lead screw by the image sensor. More preferably, the control circuit is configured to control the driving voltage of the motor.

[0013] According to another aspect, the invention provides a method for controlling operation of a medicament delivery device. Preferably, the invention provides a method for controlling operation of a medicament delivery device as defined in the above aspect. The method comprises driving, by a motor, a lead screw for driving a plunger for expelling a medicament; sensing, by an image sensor, movement of the lead screw when being driven by the motor; and controlling, by a control circuit, the motor depending on the result of the sensing of the image sensor.

[0014] The image sensor may sense the thread pattern of the lead screw. Preferably, the image sensor may sense axial position shifts of at least one of the threads of the lead screw.

[0015] According to a preferred method, the control circuit controls the power supply to the motor depending on the result of the sensing of movement of the lead screw by the image sensor. The control circuit may control the driving voltage of the motor.

[0016] Preferably, the image sensor compares the sensed axial position shifts with a reference value or threshold value. More preferably, the image sensor detects an abnormal behaviour of the lead screw if the sensed movement of the lead screw is at or below the reference value or threshold value. The control circuit may increase the driving voltage of the motor to increase the speed of the motor as soon as an abnormal behaviour is detected. Also preferably, the control circuit may reduce the driving voltage of the motor to reduce the speed and increase the applied force of the motor as soon as an abnormal behaviour is detected. The control circuit may subsequently increase the driving voltage of the motor as soon as the image sensor detects that the abnormal behaviour is terminated. Also preferably, the control circuit may calculate an updated medicament delivery time based on the reduced speed of the motor.

[0017] According to a further preferred aspect, the control circuit may stop the motor and medicament delivery if it is determined by the sensor that the abnormal behaviour cannot be resolved.

[0018] According to a further preferred aspect, the control circuit may calculate the difference between actual stroke due to abnormal behaviour and the expected stroke. Preferably, the control circuit increases the injection time for compensating the calculated stroke difference.

[0019] 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.

[0020] 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.

[0021] Similarly, the terms "transverse", "transversal" and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0022] 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.

[0023] Further, in the following description, the wording medicament delivery device will be used. In this context, medicament delivery devices may include a number of devices capable of delivering certain doses of medicament to a user, such as e.g. injection devices with or without injection needles, etc. The medicament delivery devices may be of either disposable type or reusable type and may be provided with medicament containers suitably arranged for specific drugs in specific forms.

[0024] These and other aspects of, and advantages with, the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings.

[0025] BRIEF DESCRIPTION OF DRAWINGS

[0026] In the following detailed description of the invention, reference will be made to the accompanying drawings, of which Fig. 1 is a figure of a medicament delivery device according to one embodiment, with some components of the device omitted for illustration purposes,

[0027] Fig. 2 shows a magnified perspective view of a part of the medicament delivery device of Fig. 1, Fig. 3 shows different graphs of lead screw movement over time, illustrating stall detection, Fig. 4 shows different graphs of lead screw movement over time,

[0028] Fig. 5 illustrates a further embodiment of the present invention where the sensor data of the image sensor are used for injection speed control, and

[0029] Fig. 6 illustrates a further embodiment of the present invention where the sensor data of the image sensor are used for injection stroke monitoring.

[0030] DETAILED DESCRIPTION OF THE INVENTION

[0031] An exemplary medicament delivery device embodying the present invention is shown in the figures.

[0032] Fig. 1 shows a medicament delivery device 1 with the housing parts omitted for illustration purposes. The left hand side is the proximal end that is supposed to be contacted to the skin of the user. The medicament delivery device 1 comprises a lead screw 10 for driving a plunger for expelling a medicament from a medicament container. The medicament delivery device 1 also comprises a drive unit, and other components required to expel a medicament, as known to the skilled person. The drive unit comprises a motor, in particular an electric motor, for driving the lead screw 10. Furthermore, the medicament delivery device 1 comprises a control circuit 11 with a processor for controlling the motor, and an image sensor 12 for sensing movement of the lead screw 10 when being driven by the motor for expelling medicament. The control circuit 11 and the image sensor 12 are mounted on a printed circuit board, PCB. The image sensor can be implemented, for example, by the senso Pixart PAT9125EL.

[0033] The lead screw 10 is accommodated in an inner housing component that can be called a chassis. The chassis has a through hole 13, preferably in radial direction, as can be seen in Fig. 2. The image sensor 12 is arranged on the PCB such that it "sees", i.e. senses, through the through hole 13. Thus, the image sensor 12 can "see" the thread pattern of lead screw 11. According to a preferred embodiment, during expelling the medicament, the lead screw 10 moves axially only, i.e., it does not rotate during operation. Thus, the thread pattern of the lead screw 10 moves in proximal direction relative to the image sensor 12 when it acts on the plunger rod to deliver the medicament, and is then retracted in distal direction when drug delivery is completed. The image sensor 10 recognizes a position shift of the threads of the thread pattern, which sensed position shift is the processed to identify the motion and speed of the lead screw 10.

[0034] According to an aspect of the present invention, utilization of this sensor data includes detecting plunger rod stall.

[0035] Fig. 3 illustrates different graphs of lead screw movement (in number of counts) over time. Graph (1) represents a normal operation of the medicament delivery device, i.e., normal movement of the lead screw 10 at a driving speed of the lead screw of 1 mm / s. Fig. 3 also shows five graphs of abnormal movement where the speed of the lead screw 10 and thus of the plunger rod is significantly slowed down after a while. These graphs reflect the situation that the medicament delivery process is slowed down or even blocked by high resistance caused by the medicament delivery device or the user's tissue, or malfunction of motor control system. The lowermost graph actually shows a backward movement of the lead screw, for example a detection error due to dramatic vibration or the lead screw was really retreating because of the abnormal situation.

[0036] According to a preferred embodiment, the sensed behavior of the lead screw thread pattern is used by the drive unit to optimize the motor performance and power consumption. If the image sensor detects abnormal injection behaviors such as the motor is entirely stalled, or the motor speed is reduced to a speed lower than expected, the drive unit or the control circuit of the medicament delivery device is configured to increase the motor power voltage to overcome the high resistance. For example, the drive unit is operated at voltages of 6V, 9V or 12V power for motor.

[0037] Fig. 4 shows different graphs of lead screw movement over time at a driving speed of the lead screw of 2mm / s. In all the graphs shown, the lead screw movement is performed under normal conditions, i.e., at a constant speed. The initial part of the graphs is linear increase of distance over time. Fig. 4 illustrates another preferred advantage of the invention, that is to identify malfunction of the medicament delivery device. In the illustrated examples, abnormal vibration occurs. In the examples, the medicament delivery device is vibrating with noise at certain injection speeds. The data sensed by the image sensor 12 and processed by the control circuit 11 show a disturbance larger than usual or larger that during normal operation at the beginning of the medicament delivery. The medicament delivery device, i.e., its control circuit is configured to react to such abnormal behavior, e.g. by automatically shutting down the medicament delivery device to prevent further hazard.

[0038] If increasing the driving voltage and decreasing the lead screw speed does not overcome a motor stall issue, the injection process is stopped, and retraction of the lead screw is started. Preferably, error messages are recorded in a memory of the medicament delivery device together with information about the compensation measures the control circuit tried and their corresponding results.

[0039] Fig. 5 illustrates a further embodiment of the present invention. In this embodiment, the sensor data of the image sensor are used for injection speed control. The drive unit is configured to have its own default settings about injection speed to optimize force and injection time. Thus, the drive unit can provide a higher force with lower speed for high viscosity drugs, for example. Fig. 5 shows a graph representing the expected path of movement of the lead screw 10. When it is sensed by means of the image sensor 12 that the speed of the lead screw and thus of the drive unit does not match the expected value, for example due to high resistance, the drive unit is controlled to reduce the motor speed, and to provide a higher driving force to the led screw and thus to the plunger, and to overcome the resistance. This is illustrated in Fig. 5 by the part of the graph being flatter than the expected path, i.e. having a lower increase.

[0040] Preferably, this phase of higher driving force is followed by a phase of increased speed to pull the speed up after it passes the highest resistance area. If the image sensor and / or control circuit detect that the motor speed can be increased, the drive unit moves the motor faster to compensate the short stroke occurring at the preceding phase of low speed and high force. Alternatively, for the case the high resistance phase does not end, the control circuit is configured to calculate or estimate an updated injection time, being longer that the initial expected injection time. The new injection time is preferably indicated to the user, for example in a user interface such as a LED injection progress bar.

[0041] Fig. 6 illustrates a further embodiment of the present invention. In this embodiment, the sensor data of the image sensor are used for injection stroke monitoring.

[0042] The typical close-loop speed or position control of the drive unit and lead screw might not be feasible because resistance from drug container is speed-dependent and may have high deviation. Therefore, the compensation applied in open-loop control might be more suitable, making compensation based on feedback signals.

[0043] Fig. 6 shows a graph representing the expected path of movement of the lead screw 10. When it is sensed by means of the image sensor 12 that the speed of the lead screw and thus of the drive unit does not match the expected value, for example due to high resistance, the drive unit is controlled to add extra stroke and injection time. Fig. 6 shows a phase of lower speed which requires stroke compensation. The short stroke due to losing steps during the phase of reduced speed is calculated and added back in this embodiment in terms of extra stroke and injection time. Once injection passes the most resistant part and returns to proper speed, the lost part of stroke is be known and can be added to the delivery sequence. The lower graph in Fig. 6 illustrates this third phase of normal speed after the phase of reduced speed.

[0044] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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 (H ER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent 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 (TIG IT) 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] The invention is further defined by the following clauses:

[0056] 1. Medicament delivery device comprising a lead screw for driving a plunger for expelling a medicament, a motor for driving the lead screw, a control circuit for controlling the motor, and an image sensor for sensing movement of the lead screw when being driven by the motor.

[0057] 2. Medicament delivery device of clause 1, wherein the image sensor is comprised in the control circuit.

[0058] 3. Medicament delivery device of clause 1 or 2, wherein the image sensor is configured to sense the thread pattern of the lead screw.

[0059] 4. Medicament delivery device of clause 3, wherein the image sensor is configured to sense axial position shifts of at least one of the threads of the lead screw.

[0060] 5. Medicament delivery device of clause 4, wherein the image sensor is configured to compare the sensed axial position shifts with a reference value or threshold value.

[0061] 6. Medicament delivery device of clause 5, wherein the image sensor is configured to detect an abnormal behaviour of the lead screw if the sensed movement of the lead screw is at or below the reference value or threshold value.

[0062] 7. Medicament delivery device of any one of the preceding clauses, wherein the lead screw has a longitudinal axis, is axially moveable along its longitudinal axis, and is non-rotatable. Medicament delivery device of any one of the preceding clauses, wherein the control circuit is configured to control the motor depending on the result of the sensing of movement of the lead screw by the image sensor. Medicament delivery device of clause 8, wherein the control circuit is configured to control the power supply to the motor depending on the result of the sensing of movement of the lead screw by the image sensor. Medicament delivery device of clause 9, wherein the control circuit is configured to control at least one of the driving voltage of the motor and the driving speed of the motor. Method for controlling operation of a medicament delivery device, preferably as defined in any one of the preceding clauses, the method comprising: driving, by a motor, a lead screw for driving a plunger for expelling a medicament; sensing, by an image sensor, movement of the lead screw when being driven by the motor; and controlling, by a control circuit, the motor depending on the result of the sensing of the image sensor. Method of clause 11, wherein the image sensor senses the thread pattern of the lead screw. Method of clause 12, wherein the image sensor senses axial position shifts of at least one of the threads of the lead screw. Method of clause 11, 12, or 13, wherein the control circuit controls the power supply to the motor depending on the result of the sensing of movement of the lead screw by the image sensor. Method of clause 14, wherein the control circuit controls the driving voltage of the motor. 16. Method of any one of clauses 13 to 15, wherein the image sensor compares the sensed axial position shifts with a reference value or threshold value.

[0063] 17. Method of clause 16, wherein the image sensor detects an abnormal behaviour of the lead screw if the sensed movement of the lead screw is at or below the reference value or threshold value.

[0064] 18. Method of clause 17, wherein the control circuit increases the driving voltage of the motor to increase the speed of the motor as soon as an abnormal behaviour is detected.

[0065] 19. Method of clause 17, wherein the control circuit reduces the driving voltage of the motor to reduce the speed and increase the applied force of the motor as soon as an abnormal behaviour is detected, and / or wherein the control circuit reduces the driving signal frequency of the motor to reduce the speed and increase the applied force of the motor as soon as an abnormal behaviour is detected.

[0066] 20. Method of clause 19, wherein the control circuit subsequently increases the driving voltage of the motor as soon as the image sensor detects that the abnormal behaviour is terminated.

[0067] 21. Method of clause 19, wherein the control circuit calculates an updated medicament delivery time based on the reduced speed of the motor.

[0068] 22. Method of clause 17, wherein the control circuit stops the motor and medicament delivery if it is determined by the sensor that the abnormal behaviour cannot be resolved.

[0069] 23. Method of clause 17, wherein the control circuit calculates the difference between actual stroke due to abnormal behaviour and the expected stroke.

[0070] 24. Method of clause 23, wherein the control circuit increases the injection time for compensating the calculated stroke difference.

Claims

Claims1. Medicament delivery device comprising a lead screw for driving a plunger for expelling a medicament, a motor for driving the lead screw, a control circuit for controlling the motor, and an image sensor for sensing movement of the lead screw when being driven by the motor.

2. Medicament delivery device of claim 1, wherein the image sensor is comprised in the control circuit.

3. Medicament delivery device of claim 1 or 2, wherein the image sensor is configured to sense the thread pattern of the lead screw.

4. Medicament delivery device of claim 3, wherein the image sensor is configured to sense axial position shifts of at least one of the threads of the lead screw.

5. Medicament delivery device of claim 4, wherein the image sensor is configured to compare the sensed axial position shifts with a reference value or threshold value.

6. Medicament delivery device of claim 5, wherein the image sensor is configured to detect an abnormal behaviour of the lead screw if the sensed movement of the lead screw is at or below the reference value or threshold value.

7. Medicament delivery device of any one of the preceding claims, wherein the lead screw has a longitudinal axis, is axially moveable along its longitudinal axis, and is non-rotatable.

8. Medicament delivery device of any one of the preceding claims, wherein the control circuit is configured to control the motor depending on the result of the sensing of movement of the lead screw by the image sensor.

9. Medicament delivery device of claim 8, wherein the control circuit is configured to control the power supply to the motor depending on the result of the sensing of movement of the lead screw by the image sensor.

10. Medicament delivery device of claim 9, wherein the control circuit is configured to control at least one of the driving voltage of the motor and the driving speed of the motor.

11. Method for controlling operation of a medicament delivery device, preferably as defined in any one of the preceding claims, the method comprising: driving, by a motor, a lead screw for driving a plunger for expelling a medicament; sensing, by an image sensor, movement of the lead screw when being driven by the motor; and controlling, by a control circuit, the motor depending on the result of the sensing of the image sensor.

12. Method of claim 11, wherein the image sensor senses the thread pattern of the lead screw.

13. Method of claim 12, wherein the image sensor senses axial position shifts of at least one of the threads of the lead screw.

14. Method of claim 11, 12, or 13, wherein the control circuit controls the power supply to the motor depending on the result of the sensing of movement of the lead screw by the image sensor.

15. Method of claim 13 or 14, wherein the image sensor compares the sensed axial position shifts with a reference value or threshold value.

16. Method of claim 15, wherein the image sensor detects an abnormal behaviour of the lead screw if the sensed movement of the lead screw is at or below the reference value or threshold value.

17. Method of claim 16, wherein the control circuit (i) increases the driving voltage of the motor to increase the speed of the motor as soon as an abnormal behaviour is detected, or (ii) reduces the driving voltage of the motor to reduce the speed and increase the applied force of the motor as soon as an abnormal behaviour is detected, and / or wherein the control circuit reduces the driving signal frequency of the motor to reduce the speedand increase the applied force of the motor as soon as an abnormal behaviour is detected, or (iii) wherein the control circuit stops the motor and medicament delivery if it is determined by the sensor that the abnormal behaviour cannot be resolved.

Images