TITLE
A METHOD FOR ASSESSING A DESIGN OF A MEDICAMENT DELIVERY DEVICE
TECHNICAL FIELD
The present disclosure generally relates to a method for assessing a design of a medicament delivery device and a method for testing the operation of a medicament delivery device.
BACKGROUND
Medicament delivery devices such as auto-injectors, inhalers, or on-body devices are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes or people who are undergoing an artificial fertilization procedure may require repeated injections of insulin or 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.
The functional performance of medicament delivery devices, in particular, autoinjectors is primarily advised by ISO 11608-1, where activation of autoinjectors is required to be tested against a rigid plate. However, the stiffness of a hard plate is not representative of the viscoelastic human body, especially for softer tissue areas. The mechanical properties of the injection site can play a major role in the design and development of autoinjectors, as part of the force is used and lost in the deformation of the human skin, which acts as a flexible interface.
To overcome this gap, a silicone-based test model of differing stiffness and surface properties was developed, which may represent the range and behavior of human tissues and can be used to evaluate the activation performance of injection systems. This work focuses on the assessment of the broad mechanical performance of silicone and the influence of boundary constraints.
SUMMARY
The invention is defined by the appended claims, to which reference should now be made.
In the present disclosure, when the term "distal direction" is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term "distal part/end" is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term "proximal direction" is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term "proximal part/end" is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
Further, the term "longitudinal", "longitudinally", "axially" or "axial" refers to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
Similarly, the terms "transverse", "transversal" and "transversally" refer to a direction generally perpendicular to the longitudinal direction.
Further, the terms "circumference", "circumferential", or "circumferentially" refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component. Similarly, "radial" or "radially" refer to a direction extending radially relative to the axis, and "rotation", "rotational" and "rotationally" refer to rotation relative to the axis.
There is hence provided a method for testing an operation of a medicament delivery device having a delivery mechanism that is configured to be activated by pressing the medicament delivery device on a flexible surface, the method comprising: providing a testing component having a resilient part to simulate skin stiffness of a targeted user group of the medicament delivery device; pressing the medicament delivery device against the resilient part; and measuring the reaction force on the medicament delivery device received from the resilient part until the delivery mechanism is activated.
The resilient part can be made of silicone or gel. In a preferred embodiment, the resilient part is made of silicone. Thus, the embodiments below are explained with the resilient part being a silicone part.
Preferably, according to another embodiment, the medicament delivery device is an autoinjector comprising a housing, a delivery member guard telescopically arranged within the housing.
Preferably, according to another embodiment, the delivery mechanism is accommodated within the housing and is configured to be activated when the delivery member guard is moved further into the housing.
Silicone is a proved material that has viscoelastic mechanical behavior being closer to human/mammal’s skin tissue. Thus, using a testing component having a silicone part can properly simulate the skin behavior when the medicament delivery device presses onto the silicone part. As the vary skin stiffness might bring significant impact to activation the medicament delivery device is configured to be activated by pressing the medicament delivery device on a surface, by choosing the silicone parts with different shore hardness can also mimic the skin stiffness of different user group, e.g., obesity patient group or military-used emergency user group; or different body parts of human/mammal’s skin tissue, e.g., thigh, arm, or belly.
Preferably, according to another embodiment, the step of providing a testing component having a silicone part to simulate skin stiffness of a targeted user group of the medicament delivery device comprises steps of making the silicone part with a selectable shorn hardness. Preferably, according to another embodiment, the step of making the silicone part with a selectable shorn hardness comprises the step of adjusting the percentage of ingredients of the silicone part.
Preferably, according to another embodiment, the step of providing a testing component having a silicone part to simulate skin stiffness of a targeted user group of the medicament delivery device comprises steps of selecting the testing component from a group of testing components having silicone parts with different shorn hardness respectively.
Preferably, according to another embodiment, the step of pressing the medicament delivery device against the silicone part is performed by a static test machine.
Preferably, according to another embodiment, the static test machine comprises the load cell.
Another aspect of the invention provides a method for assessing a design of a medicament delivery device, the method comprising the steps of: providing a probe; providing a load cell connected to the probe; providing a testing component comprising a part made of silicone; wherein the testing component comprises an axis; pushing the probe onto a surface of the silicone part of the testing component; and moving the probe relative to the testing component with a predetermined speed in the direction of the axis such that a displacement of the probe causes the silicone part to deform; and measuring a relation between the deformation of the silicone part of the testing component in the direction of the axis upon being pushed by the probe and the force measured by the probe.
The method is therefore suitable for assessing a design of a medicament delivery device, such as an activation force (the force that an end user needs to apply on the medicament delivery device to initiate the medicament delivery). In particular, the method is suitable to assess the activation of a medicament delivery device that is activated by the user pushing a proximal end of the medicament delivery device against a medicament delivery site, e.g., the skin. As mentioned above, the stiffness of the skin in different user groups can be a crucial issue of designing a medicament delivery device that has a delivery mechanism that is configured to be activated by pressing the medicament delivery device on a surface, using the probe to collect the force and/or displacement data when the probe is pressing on a testing component with the silicone part. The silicone part can be made to mimic the skin tissue stiffness of the targeted user group.
Preferably, according to another embodiment, the testing component comprises a contact surface configured to be in contact with the probe or the medicament delivery device.
Preferably, according to another embodiment, the contact surface can be made of silicone with the shore hardness different from the shore hardness of the silicone part.
Preferably, according to another embodiment, the sheet component has the shore hardness different from the shore hardness of the silicone part.
Preferably, according to another embodiment, the contact surface is a sheet component being placed on the silicone part.
Preferably, according to another embodiment, the step of providing a testing component made of silicone further comprises steps of: selecting a testing component comprising a part made of silicone from at least two testing components comprising a part made of silicone respectively; wherein the parts of the at least two testing components are made of silicone with different shore hardness.
Preferably, according to another embodiment, the testing component comprises an enclosure configured to enclose the silicone part of the testing component.
Preferably, according to another embodiment, the hardness of the enclosure is harder than the hardness of the silicone part of the testing component. Preferably, according to another embodiment, the enclosure is rigid.
Preferably, according to another embodiment, the step of pushing the probe onto a surface of the silicone part of the testing component is performed by a static test machine.
Preferably, according to another embodiment, the probe comprises the load cell.
Preferably, according to another embodiment, the load cell is comprised in the static test machine.
Preferably, according to another embodiment, wherein the probe is a part of a dummy medicament delivery device.
Preferably, according to another embodiment, the medicament delivery device is an autoinjector. Thus, the probe is a part of a dummy medicament delivery device.
Preferably, according to another embodiment, the medicament delivery device is a hand-held, pen-type auto- injector.
Preferably, according to another embodiment, wherein the autoinjector is configured to be activated by pressing against a skin of a user.
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-1 a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis)) , ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example, pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.
Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD- 1/PD-L1 inhibitors/modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TOR therapies.
Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21 , Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini- BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.
Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
Furthermore, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a/an/the element, apparatus, component, means, etc." are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:
Fig. 1 shows a schematic view of a probe and a testing component of the invention;
Fig. 2 shows a result of a method of the invention with the probe of Fig. 1 and two the testing component of Fig. 1 having different hardness.
Figs 3-10 show perspective views of a medicament delivery device and a testing component of the invention in different embodiments.
DETAILED DESCRIPTION
Figs 1-9 illustrate a method for evaluating an operation of a medicament delivery device 4 having a delivery mechanism that is configured to be activated by pressing the medicament delivery device 4 on a flexible surface. As shown in Figs 2-9, the method comprises the steps of: providing a testing component 2; 2’; 2” having a resilient part to simulate skin stiffness of a targeted patient group of the medicament delivery device 4; pressing the medicament delivery device 4 against the resilient part 21 ; and measuring the reaction force on the medicament delivery device 4 received from the resilient part 21 until the delivery mechanism is activated.
The resilient part 21 can be made of silicone or gel. In a preferred embodiment, the resilient part is made of silicone. Thus, the embodiments below are explained with the resilient part being a silicone part.
In one example, the method further comprises steps of measuring a deformation of the silicone part caused by a movement of the medicament delivery device between a point where the medicament delivery device presses against the silicone part and a point where the delivery mechanism is activated. Furthermore, in one example, the deformation is measured via a displacement of the medicament delivery device, as shown in Fig. 2. In this example, the testing component extends axially along a longitudinal axis L and extends transversely in a direction transverse to the longitudinal axis L. A reference axis H extends along a surface configured to be in contact with the medicament delivery device before the surface is pressed by the medicament delivery device, as shown in Fig. 1 and Fig. 3. The measured displacement of the medicament delivery device is the displacement of the medicament delivery device towards the silicone part, along the longitudinal axis L, relative to the reference axis H.
In one example, the medicament delivery device is a pen-type autoinjector comprising a needle cover; in this example, the displacement of the medicament delivery device is referring to the displacement of the needle cover relative to the reference axis H.
In one example, the medicament delivery device is connected to a force sensor, e.g. load cell. For example, as shown in Figs 3-10, the medicament delivery device attached to a testing machine having the force sensor. Alternatively, or additionally, a force sensor, e.g., load cell is attached to the medicament delivery device.
Furthermore, the presented disclosure provides a method of assessing a design of a medicament delivery device 4 is also illustrated by Figs 1-10. This method comprises the steps of: providing a probe 1 ; a force sensor connected to the probe 1 ; providing a testing component 2; 2’; 2” comprising a part 21 made of silicone; wherein the testing component 2; 2’; 2” comprises an axis L; pushing the probe 1 onto a surface of the silicone part 21 of the testing component 2; 2’; 2”; moving the probe 1 relative to the testing component 2; 2’; 2” with a predetermined speed in the direction of the axis L such that a displacement of the probe 1 causes the silicone part 21 to deform; and measuring a relation between the deformation of the silicone part 21 of the testing component 2 in the direction of the axis upon being pushed by the probe 1 and the force measured by the probe 1 , as shown in Fig. 1. Similarly, the displacement of the probe is referring to the displacement of the probe 1 towards the silicone part 21, along the longitudinal axis L, relative to the reference axis H.
It should be noted the testing component described below can be used in both above-mentioned methods.
Silicone is selected due to the distinct advantages offered, compared to other polymeric materials, such as environmental resistance, high versatility for rapid prototyping, durability, and range of hardness. In one example, the shore hardness of the at least two testing components are from Durometer scales 000 (with the configuration of 6.35 mm spherical radius, 10.7-11.6 mm diameter, 2.54 mm extension and 1.111 N of the spring force) to 00 (with the configuration of 1.2 mm spherical radius, 2.4 mm diameter, 2.54 mm extension and 1.111 N of the spring force). For example, Ecoflex™ and Dragon Skin™ series from Smooth On Inc. can be used. In one example, 3D-printed molds can be produced for fabricating cylindric silicone models. In one example, the silicone part of the testing component 2 comprises a diameter of 120 mm and a height of 120 mm, as shown in Fig. 1. It should be noted that the selection of the dimensions of the silicone part can be dependent on the testing objects, e.g., depending on the size of the medicament delivery device; and/or the dimensions of the silicone part can be used to adjust the stiffness of the silicone part; and/or the dimensions of the silicone part is dependent on the characteristic targeted medicament delivery site.
In one example, the testing component 2’ comprises a rigid enclosure 22 surrounds the silicone part 21 as shown in Figs 4-5, and 8-9.
In another example, the testing component 2” comprises a contact surface 23’ configured to be in contact with the probe 1 or the medicament delivery device 4. In a preferred example, the contact surface 23’ has the shore hardness different from the shore hardness of the silicone part 21, as shown in Figs 6-9. In this example, the contact surface is configured to mimic the surface skin and/or the epidermis layer of the skin, and/or the upper part of the dermis layer of the skin; and the silicone part 21 is configured to mimic the majority part of the dermis layer of the skin and/or the subcutaneous tissue. The contact surface can be made of silicone with the shore hardness different from the shore hardness of the silicone part 21 , and/or the contact surface can be made of material different from the silicone part. The contact surface may have a thickness measured along the axis L. As shown in Figs 6-9, the contact surface 23’ can be used with or without the rigid enclosure 22.
In a one example, to evaluate the mechanical behavior of the silicone model, both above-mentioned methods can be carried with a static test machine, e.g., MTS Insight ®, with a load cell as the force sensor. In the example wherein the probe is used in the method, the probe 1 can be an indenting probe 1 having a diameter of 14.5mm. It should be noted that the dimension of the probe is dependent on the testing needs, e.g., the dimension of the medicament delivery device. In one example, the probe 1 can push onto the surface of the silicone part 21 of the testing component 2 and move along the axis L with a speed of 2mm/s or 5mm/s. In addition, in another preferred example, the step of pushing the probe 1 onto a surface of the silicone part 21 of the testing component 2 comprises a step of pushing the probe 1 onto the surface of the silicone part 21 of the testing component 2 with force up to 35N. It should be noted that, the testing force and the moving speed is dependent on the testing needs, e.g., depending on the targeted user group of the medicament delivery device.
Figs 2-3 show an example of evaluating an operation of a medicament delivery device 4. In this example, the medicament delivery device comprises a housing 40 and a delivery member guard 41 configured to be pointed towards a medicament delivery site during use. The delivery member guard 41 is axially movable relative to the housing 40 from a proximal position to a distal position. The medicament delivery device 4 comprises a delivery mechanism positioned within the housing 40 and is configured to be activated when the delivery member guard is moved to the distal position. When the delivery mechanism is activated, the delivery mechanism is configured to output force to expel medicament contained within the medicament delivery device out from the housing 40. In the example as shown in Figs 2-3, the medicament delivery device is held by static test machine 5.
In another preferred example, the probe 1 is a part of a dummy medicament delivery device, e.g., a device doesn’t have a needle and/or a medicament and looks like an medicament delivery device. As can be seen from Fig. 2, the mechanical response of two representative testing components A, B is shown. The displacement of the silicone part of the testing component is method by the moving distance of the probe 1. These two models, which comprised two distinctive base hardness for the silicone parts, shore hardness 000-20 for testing component A and shore hardness 00-10 testing component B, are selected to show the broad stiffness levels of the silicon- based test cylinder between softer testing component (A, 65-85 mm displacement range) and harder testing component (B, 25-35 mm displacement range). Both testing components presented stiffer behavior at a higher speed rate (5 mm/s) and full enclosure. Thus, the silicone-based test model demonstrated the capability to significantly vary the stiffness between soft and hard conditions, suggesting the importance of considering human skin tissue mechanics in autoinjector functional assessment. The mechanical properties of silicone together with its long-term reliability represent key aspects in considering these testing components as an important test model for the medicament delivery device industry, particularly when assessing and developing new autoinjectors. For example, a group of the testing components with silicone parts having different stiffness respectively can be provided. The range of the stiffness within this group of testing components are dependent on the targeted user group and/or usage scenario of the medicament delivery device. For example, when developing an autoinjector aiming to obesity treatment, the skin tissue characteristics of the obesity patience group can be precollected, e.g., by historical data or clinical studies. The testing components can be made according to the skin tissue characteristics of the obesity patience group. Thus, the medicament delivery device can be designed based on the testing data obtained from the method of assessing a design of a medicament delivery device as disclosed above. Furthermore, the medicament delivery device produced based on those testing data can be further tested by the method for evaluating an operation of a medicament delivery device having a delivery mechanism that is configured to be activated by pressing the medicament delivery device on a surface as mentioned above to assure the design is fitted for the needs of the user group.
It should be noted that the method can be used on end users to investigate real-time skin/tissue behavior during autoinjector activation, which would allow the correlation of the test model with the target population. Furthermore, the method as disclosed above can be used to test the operation of the medicament delivery device is an autoinjector comprising a housing, a delivery member guard telescopically arranged within the housing. The delivery mechanism is accommodated within the housing and is configured to be activated when the delivery member guard is moved further into the housing. For example, the delivery mechanism comprises a power source, e.g., a spring, a gas canister, or a motor, the power source is configured to output power upon the delivery mechanism is activated. The output power is configured to expel medicament from a medicament container configured to be accommodated within the medicament delivery device.
In one example, the step of providing a testing component having a silicone part to simulate skin stiffness of a targeted patient group of the medicament delivery device comprises steps of making the silicone part with a selectable shorn hardness.
In another example, the step of making the silicone part with a selectable shorn hardness comprises the step of adjusting the percentage of ingredients of the silicone part. Alternatively, or additionally, the step of providing a testing component having a silicone part to simulate skin stiffness of a targeted patient group of the medicament delivery device comprises steps of selecting the testing component from a group of testing components having silicone parts with different shorn hardness respectively.
Similarly as above-mentioned examples, the step of pressing the medicament delivery device against the silicone part is performed by a static test machine. In another example, the static test machine comprises the load cell.
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.
Other aspects of the invention are defined by the following clauses.
1. A method for assessing a design of a medicament delivery device, the method comprising the steps of: providing a probe; providing a force sensor connected to the probe; providing a testing component comprising a resilient part; wherein the testing component comprises an axis; pushing the probe onto a surface of the silicone part of the testing component; moving the probe relative to the testing component with a predetermined speed in the direction of the axis such that a displacement of the probe causes the resilient part to deform; and measuring a relation between the deformation of the resilient part of the testing component in the direction of the axis upon being pushed by the probe and the force measured by the probe. The method according to clause 1, wherein the resilient part is made of silicone. The method according to clause 1 or 2, wherein the step of providing a testing component further comprises steps of: selecting a testing component comprising a resilient part from at least two testing components comprising a resilient part respectively; wherein the resilient parts of the at least two testing components having different shore hardness. The method according to clause 1 or 2, wherein the step of providing a testing component further comprises steps of: making a testing component comprising a resilient part with a selectable material hardness. The method according to any one of the preceding clauses, wherein the step of pushing the probe onto a surface of the resilient part of the testing component is performed by a static test machine. The method according to clause 4, wherein the static test machine comprises the load cell as the force sensor. The method according to any one of the preceding clauses, wherein the probe is a part of a dummy autoinjector. A method for evaluating an operation of a medicament delivery device having a delivery mechanism that is configured to be activated by pressing the medicament delivery device on a surface, the method comprising: providing a testing component having a resilient part to simulate skin stiffness of a targeted user group of the medicament delivery device; pressing the medicament delivery device against the resilient part; and measuring the reaction force on the medicament delivery device received from the resilient part until the delivery mechanism is activated. The method according to clause 8, wherein the resilient part is made of silicone. The method according to clause 8 or 9, the step of providing a testing component having a resilient part to simulate skin stiffness of a targeted user group of the medicament delivery device comprises steps of making the silicone part with a selectable shorn hardness. The method according to clause 8 or 9, the step of making the resilient part with a selectable shorn hardness comprises the step of adjusting the percentage of ingredients of the resilient part. The method according to clause 8 or 9, the step of providing a testing component having a resilient part to simulate skin stiffness of a targeted user group of the medicament delivery device comprises steps of selecting the testing component from a group of testing components having resilient parts with different shorn hardness respectively. The method according to any one of clauses 8-12, wherein the step of pressing the medicament delivery device against the resilient part is performed by a static test machine. The method according to any one of clauses 8-13, the method further comprises steps of: measuring a deformation of the resilient part caused by a movement of the medicament delivery device between a point where the medicament delivery device presses against the resilient part and a point where the delivery mechanism is activated.
15. The method according to clause 14, wherein the deformation is measured via a displacement of the medicament delivery device.
16. The method according to any one of clauses 8-15, wherein the medicament delivery device is an autoinjector comprising a housing, a delivery member guard telescopically arranged within the housing; and wherein the delivery mechanism is accommodated within the housing and is configured to be activated when the delivery member guard is moved further into the housing.
17. The method according to any one of clauses 8-16, wherein the testing component comprises a contact surface being made of material with the shore hardness different from the shore hardness of the resilient part.
18. A testing component configured to be used in the method according to any one of the preceding clauses, wherein the testing component comprises a part made of silicone.
19. The testing component according to clause 18 comprises a contact surface can be made of silicone with the shore hardness different from the shore hardness of the silicone part; wherein the contact surface is configured to be in contact with an object for applying force on to the silicone part of the testing component and deforming the silicone.