A liquid delivery device operation measurement system

Abstract

A liquid delivery device operation measurement system comprising: a testing plate configured to be contact with a liquid delivery device; wherein an opening is arranged in the testing plate such that liquid contained within the liquid delivery device can be expelled through the opening of the testing plate; wherein the liquid delivery device is configured to generate a sound and / or vibration related to the expelling of the liquid; an optical sensor configured to detect the liquid which passes through the opening of the test plate; a sound and / or vibration sensor configured to detect the sound and / or vibration of the liquid delivery device; a processor configured to perform the following steps in the following orders: recording a start of the liquid delivery when the liquid is detected by the optical sensor; recording an end of the liquid delivery when the optical sensor no longer detects the liquid further passes through the opening of the test plate; and calculating a time between a detection of the sound and / or vibration sensor and the recorded start and / or the end.

Description

[0001] TITLE

[0002] A LIQUID DELIVERY DEVICE OPERATION MEASUREMENT SYSTEM

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to a liquid delivery device operation measurement system, in particular, the measurement system comprises an optical sensor.

[0005] BACKGROUND

[0006] Medicament delivery devices such as auto- injectors, insulin pens, or on-body devices are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes or people who are undergoing an artificial fertilization procedure may require repeated injections of insulin or hormones. Other patients may require regular injections of other types of medicaments, such as a growth hormone. Therefore, medicament delivery devices for self-administration usually are arranged with multiple automatic functions and protection features. For example, a medicament delivery member guard is commonly used. The medicament delivery member guard is configured to cover a medicament delivery member, e.g., an injection needle so that a user will not accidentally be in contact with the medicament delivery member.

[0007] Testing an operation of a medicament delivery device is crucial for medicament delivery device development and / or quality control of the manufacture of medicament delivery devices. Thus, there is a need to further improve the testing assembly and the testing method for testing the operation of a medicament delivery device.

[0008] SUMMARY

[0009] The invention is defined by the appended claims, to which reference should now be made.

[0010] There is hence provided a liquid delivery device operation measurement system comprising: a testing plate configured to be in contact with a liquid delivery device. An opening is arranged in the testing plate such that liquid contained within the liquid delivery device can be expelled through the opening of the testing plate. The liquid delivery device is configured to generate a sound and / or vibration related to the expelling of the liquid; an optical sensor configured to detect the liquid which passes through the opening of the test plate; a sound and / or vibration sensor configured to detect the sound and / or vibration of the liquid delivery device; a processor configured to perform the following steps in the following orders: recording a start of the liquid delivery when the liquid is detected by the optical sensor; recording an end of the liquid delivery when the optical sensor no longer detects the liquid further passes through the opening of the test plate; and calculating a time between a detection of the sound and / or vibration sensor and the recorded start and / or the recorded end.

[0011] Preferably, according to another embodiment, before the step of recording a start of the liquid delivery when the liquid is detected by the optical sensor, the processor is configured to perform the following steps in the following orders: defining an effective detection area; and recording the start of the liquid delivery when the liquid is detected by the optical sensor in the effective detection area.

[0012] Preferably, according to another embodiment, the processor is configured to perform the following steps in the following orders: defining a threshold value; and recording the detection of the sound and / or vibration sensor when the detected magnitude of the sound and / or vibration is above the threshold value.

[0013] Preferably, according to another embodiment, the system comprises a weight measurement device and a container placed on the weight measurement device and lined up with the opening of the testing plate.

[0014] Preferably, according to another embodiment, the container is configured to receive the expelled liquid. Preferably, according to another embodiment, the processor is configured to perform the following steps in the following orders: calculating a time between a weight change of detection of the weight measurement device and

[0015] • the detection of detection of the sound and / or vibration sensor; and / or

[0016] • the recorded start and / or the end.

[0017] Preferably, according to another embodiment, the processor is configured to perform the following steps in the following orders: defining a threshold value; and recording the detection of the weight measurement device when the measured weight is above the threshold value.

[0018] Preferably, according to another embodiment, the optical sensor comprises an image capturing sensor.

[0019] Preferably, according to another embodiment, the optical sensor comprises a camera.

[0020] Preferably, according to another embodiment, the optical sensor comprises a CCD camera.

[0021] Preferably, according to another embodiment, the optical sensor comprises a laser emitter and a laser receiver.

[0022] Preferably, according to another embodiment, the optical sensor comprises an infrared emitter and an infrared receiver.

[0023] Preferably, according to another embodiment, the sound and / or vibration is a piezoelectric sensor.

[0024] Preferably, according to another embodiment, the sound and / or vibration is a microphone. Preferably, according to another embodiment, the system comprises a shield extending in a direction transverse to the testing plate.

[0025] Preferably, according to another embodiment, the shield is configured to surround the opening of the testing plate.

[0026] Preferably, according to another embodiment, the system comprises a holder assembly.

[0027] Preferably, according to another embodiment, the holder assembly comprises a grabber configured to be engaged with a liquid delivery device, a mover configured to move linearly towards the testing plate and away from the testing plate.

[0028] Preferably, according to another embodiment, the mover is attached to the grabber and a force sensor.

[0029] Preferably, according to another embodiment, the holder assembly comprises a secondary grabber configured to be engaged with a cap of the liquid delivery device.

[0030] Preferably, according to another embodiment, the system comprises a second grabber pivotally relative to the testing plate.

[0031] Preferably, according to another embodiment, the force sensor is electrically connected to the processor.

[0032] Preferably, according to another embodiment, the force sensor is a load cell.

[0033] Preferably, according to another embodiment, the processor is configured to receive a testing receipt containing information related to the liquid delivery device.

[0034] Preferably, according to another embodiment, the processor is configured to control at least one of the sensors based on the received information.

[0035] Preferably, according to another embodiment, the liquid delivery device can be used in the liquid delivery device operation measurement system is a medicament delivery device.

[0036] Preferably, according to another embodiment, the medicament delivery device is an autoinjector. Preferably, according to another embodiment, the medicament delivery device is a hand-held, pen-type autoinjector, an insulin pen, a safety syringe, an infusion pump, an on-body device.

[0037] Preferably, according to another embodiment, the optical sensor is configured to detect a position of a tip of a delivery member of the liquid delivery device.

[0038] Preferably, according to another embodiment, the optical sensor is configured to detect a position of a portion of the delivery member adjacent to the testing plate.

[0039] Preferably, according to another embodiment, the delivery member is a needle or a spray nozzle.

[0040] 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-1a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis)) , ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example, pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.

[0041] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0042] 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.

[0043] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, I VAC, 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.

[0044] 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.

[0045] 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.

[0046] BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0048] Fig. 1 shows a perspective view of a liquid delivery device operation measurement system of the disclosure;

[0049] Fig. 2 shows a perspective view of a holder assembly and a second grabber;

[0050] Figs 3-5 show perspective views of an operation sequence of the holder assembly of Fig. 2 and the second grabber of Fig. 2;

[0051] Figs 6A-6B show images captured from an optical sensor of the system of Fig. 1 ;

[0052] Fig. 7 shows a relation between the detection of the optical sensor and time;

[0053] Figs 8-9 show relation between a detection of a sound and / or vibration sensor of the system of Fig. 1 and time;

[0054] Fig. 10 shows relation between a detection of a sound and / or vibration sensor of the system of Fig. 1 and time;

[0055] Fig. 11 shows the detection of Fig. 10 after waveform shaping;

[0056] Fig. 12 shows relation between a detection of a weight measurement device of the system of Fig. 1 and time;

[0057] Fig. 13 shows relation between a detection of a force sensor of the system of Fig. 1 and time; and

[0058] Figs 14-17 show perspective views and cross-section view of a liquid delivery device that can be used in the system of Fig. 1 ;

[0059] Figs 18-23 show perspective views of another example of the liquid delivery device operation measurement system of Fig. 1. DETAILED DESCRIPTION

[0060] Figs 1-15 illustrate a liquid delivery device operation measurement system. The liquid delivery device operation measurement system is configured to test an operation of a liquid delivery device, in particular, a medicament delivery device such as an autoinjector. The system can be used to test a medicament delivery device in the market, e.g., the medicament delivery device contains medicament. Additionally, the system can be used to test a medicament delivery device in an early developing stage, e.g., instead of containing medicament, the medicament delivery device may contain water. The system is configured to test if the liquid delivery device is able to expel the contained liquid, and / or is able to expel a predetermined amount of the contained liquid, and / or is able to expel the contained liquid within a predetermined time period. Furthermore, the system is configured to test if an indication provided by the liquid delivery device is reflecting a progress of the liquid delivery operation. For example, many of the medicament delivery devices are required to have an indication indicating a progress of the medicament delivery operation, e.g., a start of the delivery, the medicament is delivering, and / or an end of the delivery. Thus, there is a need to test if the indication reflects the medicament delivery operation, e.g., to test if the medicament is stopped from being expelled, when a click is provided to indicate the end of the medicament delivery.

[0061] As shown in Fig. 1, the liquid delivery device operation measurement system comprises a testing plate 10 configured to be in contact with a liquid delivery device 90. An opening 11 is arranged in the testing plate 10 such that liquid contained within the liquid delivery device can be expelled through the opening 11 of the testing plate 10. The liquid delivery device 90 is configured to generate a sound and / or vibration related to the expelling of the liquid.

[0062] The system comprises an optical sensor 20 configured to detect the liquid which passes through the opening 11 of the test plate 10. In one example, the optical sensor 20 is attached to a rack 21 around the testing plate 10. A sound and / or vibration sensor 30 configured to detect the sound and / or vibration of the liquid delivery device 90. In one example, the sound and / or vibration sensor 30 is attached to a rack 31 around the testing plate 10. In one example, the sound and / or vibration sensor 30 is a microphone, preferably, a piezoelectric microphone. A processor configured to perform the following steps in the following orders: recording a start of the liquid delivery when the liquid is detected by the optical sensor 20; recording an end of the liquid delivery when the optical sensor 20 no longer detects the liquid further passes through the opening 11 of the test plate 10; and calculating a time between a detection of the sound and / or vibration sensor 30 and the recorded start and / or the recorded end.

[0063] In one example, the liquid delivery device is configured to provide a sound and / or vibration to indicate an ended of the liquid delivery. In this example, the processor is configured to calculate a time between a detection of the sound and / or vibration sensor 30 and the recorded end. In another example, the liquid delivery device is configured to provide a sound and / or vibration to indicate an ended of the liquid delivery of a start of the liquid delivery device and a sound and / or vibration to indicate an ended of the liquid delivery. In this example, the processor is configured to calculate a time between a detection S1 of the sound and / or vibration sensor 30 and the recorded start 01 and to calculate a time T 1 between a detection S2 of the sound and / or vibration sensor 30 and the recorded end 02, as shown in Figs 7-8. In the example as shown in Figs 7-8, the time between a detection S1 of the sound and / or vibration sensor 30 and the recorded start 01 is about zero. In another example, the liquid delivery device is configured to provide multiple sound and / or vibration to indicate the liquid delivery from the start to the end, as shown in Fig. 9. In this example, the processor can operate similarly as above-mentioned examples, e.g., calculating a time between the first detected sound and / or vibration and the recorded start and / or calculating a time between the last detected sound and / or vibration and the recorded ended; the processor can calculate multiple time periods between the recorded start and / or the recorded end and each detected sound and / or vibration respectively.

[0064] In one example, the optical sensor comprises an image capturing sensor, e.g., a camera. Alternatively, or additionally, the optical sensor comprises a laser emitter and receiver; and / or an infrared emitter and receiver.

[0065] In one example, before the step of recording a start of the liquid delivery when the liquid is detected by the optical sensor, the processor is configured to perform the following steps in the following orders: defining an effective detection area 8; and recording the start of the liquid delivery when the liquid 99 is detected by the optical sensor in the effective detection area 8.

[0066] In one example, as shown in Fig. 6A, the effective detection area 8 is configured to mimic an area where the expelled liquid is designed to reach. For example, when the liquid delivery device is a medicament delivery device, the effective detection area 8 is configured to mimic an area where a user of the medicament delivery device can absorb the expelled medicament. The effective detection area 8 is defined as an area beyond a tip 92a of a delivery member 92. For example, when the liquid delivery device is an autoinjector, the effective detection area 8 is defined as an area beyond a tip 92a of a needle 92. In this example, a predetermined injection depth 81 can be defined. Alternatively, or additionally, the effective detection area 8 is defined as an area between two axes 80. For example, when the liquid delivery device is an inhalation device, only droplets within a certain droplets path can pass through a user’s throat, other droplets fall within the user’s mouth and cannot be absorbed by the user.

[0067] In one example where the liquid delivery device operation measurement system is an autoinjector, the optical sensor is configured to detect a position of a tip 92a of a needle 92 of the autoinjector. The tip detection can be used to define the effective detection area as mentioned above. Alternatively, or additionally, the tip detection can be used to test the injection depth of the medicament delivery device. Preferably, in this example, the optical sensor is configured to detect a position of a portion of the needle adjacent to the testing plate.

[0068] In one example as shown in Figs 6A-6B, the optical sensor is a camera configured to continuously take photos of a predetermined testing area. In one example, the optical sensor is configured to take photos of a predetermined testing area as shown in Fig. 6B. In this example, the effective detection area 8 can be defined by software, e.g., only shows on the photos in an image process stage.

[0069] In another example, the processor is configured to perform the following steps in the following orders: defining a threshold value; and recording the detection of the sound and / or vibration sensor when the detected magnitude of the sound and / or vibration is above the threshold value.

[0070] In this example, as shown in Fig. 10, the environment noise of the sound / vibration detection can be filtered out.

[0071] In one example, the system comprises a weight measurement device 5 and a container placed on the weight measurement device 5 and lined up with the opening 11 of the testing plate 10. The container is configured to receive the expelled liquid. In this example, an amount of the liquid can be measured. Thus, when a medicament delivery device is tested by the disclosure system, a dose accuracy can be tested. Furthermore, the weight measurement can be used to facilitate the recorded start and / or the recorded ended detection by the optical sensor. For example, as shown in Fig. 12, the processor is configured to record a first signal W1 when receive a detection of the first change of the weight measurement device 5 and record a second signal W2 when receive a detection of the last change of the weight measurement device 5. The first signal W1 and the second signal W2 can be used to calibrate the recorded start and / or the recorded end. For example, a droplet 99a might attach to the tip 92a of the delivery member 92, as shown in Fig. 6B. In this example, the second signal W2 can be used to calibrate the recorded end from the detection of the optical sensor. Similarly, the weight measurement can be used to calibrate the detection of the sound / vibration sensor. In this example, the processor is configured to perform the following steps in the following orders: calculating a time between a weight change of detection of the weight measurement device and

[0072] • the detection of detection of the sound and / or vibration sensor; and / or

[0073] • the recorded start and / or the end.

[0074] In a preferred example, the processor is configured to perform the following steps in the following orders: defining a threshold value; and recording the detection of the weight measurement device 5 when the measured weight is above the threshold value. Thus, an initial setup value of the weight measurement device 5 can be filtered out.

[0075] In one example, the system comprises a shield 4 extending in a direction transverse to the testing plate 10, e.g., the shield 4 is perpendicular to the testing plate. The shield 4 is configured to surround the opening 11 of the testing plate 10. Thus, the environment noise can be minimized.

[0076] In another example, as shown in Fig. 2, the system comprises a holder assembly 7. The holder assembly 7 comprises a grabber 70 configured to be engaged with a liquid delivery device 90, a mover 72 configured to move linearly towards the testing plate 10 and away from the testing plate 10. The mover 72 is attached to the grabber 70 and a force sensor. The grabber is configured to be engaged with the liquid delivery device. In one example, the force sensor is electrically connected to the processor. In one example, the holder assembly 7 comprises a rack 71 attaching to the grabber 70. In another example, the holder assembly 7 comprises a secondary grabber 73. A medicament delivery device may comprise a delivery member guard 91 movable to a housing 90 of the medicament delivery device. The delivery member guard 91 is configured to surround the delivery member 92 to avoid injury or contamination. Thus, the delivery member guard 91 is designed to be axially immovable relative to the housing 90 of the medicament delivery device, e.g., being locked to the housing 90. Thus, the holder assembly 7 can be used to test if the delivery member guard 91 is properly locked to the housing 90 of the medicament delivery device after the delivery operation is completed. For example, as shown in Fig. 5, the grabber 70 is engaged with the medicament delivery device 90, the mover 72 is moved in a direction D towards the testing plate 10; thus, the delivery member guard 91 is pressed against the testing plate 10. Furthermore, a medicament delivery device 90 can be designed to be activated, e.g., the medicament delivery device starts the medicament delivery operation after being activated, by pressing the delivery member guard 91 against the medicament delivery site. In this example, the holder assembly 7 is configured to measure the force magnitude to activate the device. For example, as shown in Fig. 4, the holder assembly is configured to hold and move the medicament delivery device in the direction D towards the testing plate 10; thus, the delivery member guard 91 is moved into the housing 90 of the medicament delivery device by the reaction force from the testing plate 10. For example, Fig. 13 shows a measurement between the axially force applied onto the delivery member guard 91 and the compressive extension of the delivery member guard 91. The compressive extension of the delivery member guard 91 can be measured by the relative movement between the delivery member guard 91 and the housing 90. The measurement of the force sensor can be divided as a contact point F1 where the holder assembly moves the medicament delivery device to be in contact with the testing plate 10; afterward the holder assembly is configured to further move the medicament delivery device towards the testing plate 10 such that the delivery member guard is pressed against the testing plate 10 to an activation point F2 where the medicament delivery device is activated. After the medicament delivery operation, the holder assembly is configured to move the medicament delivery device away from the testing plate 10 at a release point F3 to enable the delivery member guard 91 to extend from the housing 90 of the medicament delivery device. Then the holder assembly is configured to move the medicament delivery device towards the testing plate 10 again to press the locked delivery member guard against the testing plate 10 such that an override force F4 can be tested.

[0077] In another example, the system comprises a second grabber 6 pivotally relative to the testing plate 10. In this example, the second grabber 6 is configured to engage with the liquid delivery device 90, as shown in Fig. 2. In one example where the system comprises the holder assembly 7, a cap removal force of the liquid delivery device can be tested. For example, as shown in Fig. 3, the second grabber 6 is engaged with the liquid delivery device 90, the secondary grabber 73 of the holder assembly 7 is configured to be engaged with a cap 98 of the liquid delivery device. Thus, when the holder assembly 7 is moved in a direction II away from the testing plate 10, the cap 98 can be removed. As a result, the magnitude of the cap removal force of the medicament delivery device can be measured.

[0078] In another example, the system comprises a frame 12, a rack 13 attached to the frame. In this example, the testing plate 10 is attached to the rack 13, as shown in Fig. 1. In one example, the position of the testing plate 10 relative to the rack 13 is adjustable, e.g., via an adjusting screw 13a. In another example, the system comprises a ledge 14 attached to the rack 13. The ledge 14 is engaged with the second grabber 6. In one example, as shown in Fig. 3, the second grabber comprises a body 60, a latch 61 configured to be releasably attached to the ledge 14, and a pivot arm 62 configured to be hingely engaged with the ledge 14. As a result, once the latch 61 is released from the ledge 14, the second grabber 6 can pivot (as shown in arrow P in Fig. 4) relative to the testing plate 10.

[0079] In another example, the processor is configured to receive a testing receipt containing information related to the liquid delivery device. The processor is configured to control at least one of the sensors based on the received information. For example, the processor can connect to all sensors via wires, and receive the testing receipt wirelessly and / or via a wire. For example, the processor can receive the testing receipt from a cloud server.

[0080] In another example, the system comprises a container holder assembly 7’, as shown in Figs 18-23. In this example, the liquid delivery device can be a container, e.g., a syringe or a cartridge. The holder assembly 7’ comprises a holder body 70’ configured to accommodate the container. In one example, the container holder assembly 7’ is positioned above the testing plate 10 aiming towards the opening 11. In one example, the system comprises a rod 7T configured to be moved into the container to expel the contained liquid. In one example, as shown in Fig. 21 , the rod 7T can be one or more rods with different length respectively. In one example, the container holder 7’ is attached relative to the testing plate 10 via a magnetic lock 72’. In one example, the magnetic lock 72’ comprises a rotatable knob 73’, as shown in Fig. 23, so that the user can release the lock by rotating the rotatable knob 73’. In one example, a flow sensor 6’ can be positioned above the testing plate 10, as shown in Fig. 22. In this example, the liquid delivery device is configured to expel the liquid through the flow sensor 6’. In another example, an observation plate 8’ can be attached below the opening 11 , as shown in Fig. 19. In this example, the liquid is configured to be expelled on the observation plate 8’ such that some liquid characteristics, e.g., surface tension force, can be tested.

[0081] Figs 14-17 illustrate a liquid delivery device that can be tested by the disclosed system in any of the above-mentioned examples. In this example, the liquid delivery device is an autoinjector. The delivery device 9 comprises a housing 90; a cap 98 attached to the housing 90; a delivery member guard 91 telescopically positioned within the housing 90. The housing 90 accommodates a medicament container 93 having an integral needle 92 as a delivery member. The housing 90 also accommodates a powerpack comprising a plunger rod 94, a compression spring 95 engaged with the plunger rod 94, a pair of flexible arms 96 releasably engaged with the plunger rod 94, and a rotator 97 surrounding the pair of flexible arms 96. In this example, when the delivery member guard 91 is moved to a retracted position as shown in Fig. 17, the delivery member guard 91 rotates the rotator 97 relative to the pair of flexible arms 96. In this example, the rotator 97 comprises a support wall configured to block a radial movement of the pair of the flexible arm 96. The rotation of the rotator 97 caused by the delivery member guard 91 is configured to move the support wall of the rotator 97 away from the pair of flexible arms 96 such that once the rotator 97 is rotated, the flexible arms 96 can flex radially away from the plunger rod 94. As a result, the plunger rod 94 is moved into the medicament container 93 by the compression spring 95 to expel the medicament via the needle 92.

[0082] In another example, the liquid delivery device operation measurement system can be used to test characterization of the liquid stream from the liquid delivery device. For example, the behavior of the liquid once a needle of the liquid delivery device is inserted into a targeted delivery site.

[0083] The inventive concept has mainly been described above concerning a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

CLAIMS1. A liquid delivery device operation measurement system comprising: a testing plate configured to be in contact with a liquid delivery device; wherein an opening is arranged in the testing plate such that liquid contained within the liquid delivery device can be expelled through the opening of the testing plate; wherein the liquid delivery device is configured to generate a sound and / or vibration related to the expelling of the liquid; an optical sensor configured to detect the liquid which passes through the opening of the test plate; a sound and / or vibration sensor configured to detect the sound and / or vibration of the liquid delivery device; a processor configured to perform the following steps in the following orders: recording a start of the liquid delivery when the liquid is detected by the optical sensor; recording an end of the liquid delivery when the optical sensor no longer detects the liquid further passes through the opening of the test plate; and calculating a time between a detection of the sound and / or vibration sensor and the recorded start and / or the recorded end.

2. The liquid delivery device operation measurement system according to claim 1, wherein before the step of recording a start of the liquid delivery when the liquid is detected by the optical sensor, the processor is configured to perform the following steps in the following orders: defining an effective detection area; and recording the start of the liquid delivery when the liquid is detected by the optical sensor in the effective detection area.

3. The liquid delivery device operation measurement system according to claim 1 or 2, the processor is configured to perform the following steps in the following orders: defining a threshold value; and recording the detection of the sound and / or vibration sensor when the detected magnitude of the sound and / or vibration is above the threshold value.

4. The liquid delivery device operation measurement system according to any one of the preceding claims, wherein the system comprises a weight measurement device and a container placed on the weight measurement device and lined up with the opening of the testing plate; wherein the container is configured to receive the expelled liquid.

5. The liquid delivery device operation measurement system according to claim4, wherein the processor is configured to perform the following steps in the following orders: calculating a time between a weight change of detection of the weight measurement device and• the detection of detection of the sound and / or vibration sensor; and / or• the recorded start and / or the end.

6. The liquid delivery device operation measurement system according to claim5, the processor is configured to perform the following steps in the following orders: defining a threshold value; and recording the detection of the weight measurement device when the measured weight is above the threshold value.

7. The liquid delivery device operation measurement system according to any one of the preceding claims, wherein the optical sensor comprises an image capturing sensor.

8. The liquid delivery device operation measurement system according to any one of the preceding claims, wherein the system comprises a shield extending in a direction transverse to the testing plate; and wherein the shield is configured to surround the opening of the testing plate.

9. The liquid delivery device operation measurement system according to any one of the preceding claims, wherein the system comprises a holder assembly; wherein the holder assembly comprises a grabber configured to be engaged with a liquid delivery device, a mover configured to move linearly towards the testing plate and away from the testing plate; wherein the mover is attached to the grabber and a force sensor.

10. The liquid delivery device operation measurement system according to claim 9, wherein the system comprises a second grabber pivotally relative to the testing plate.

11. The liquid delivery device operation measurement system according to claim 9 or 10, wherein the force sensor is electrically connected to the processor.

12. The liquid delivery device operation measurement system according to any one of the preceding claims, wherein the processor is configured to receive a testing receipt containing information related to the liquid delivery device; and wherein the processor is configured to control at least one of the sensors based on the received information.

13. The liquid delivery device operation measurement system according to any one of the preceding claims, wherein the liquid delivery device can be used in the liquid delivery device operation measurement system is an autoinjector.

14. The liquid delivery device operation measurement system according to claim13, wherein the optical sensor is configured to detect a position of a tip of a needle of the autoinjector.

15. The liquid delivery device operation measurement system according to claim14, wherein the optical sensor is configured to detect a position of a portion of the needle adjacent to the testing plate.

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