Drug delivery device subassembly

Abstract

A subassembly for a medication delivery device, the subassembly including: a housing extending along a longitudinal axis between a proximal end and a distal end, the housing configured to accommodate a medication container, the medication container coupled to a medication delivery member including an outer portion for delivering the medication, the outer portion of the medication delivery member configured to extend beyond the proximal end of the housing in the direction of the longitudinal axis; and a delivery member guard partially disposed within the housing, the delivery member guard being telescopic relative to the proximal end of the housing, the delivery member guard being movable along the longitudinal axis between an extended position configured to completely surround the outer portion of the medication delivery member of the medication container, and a retracted position configured to partially surround the outer portion of the medication delivery member of the medication container.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to a subassembly of a medication delivery device, and more particularly to a subassembly of a medication delivery device that includes a medication delivery guard. [Background technology]

[0002] It is known that drug delivery devices, such as autoinjectors, inhalers, or on-body devices, are generally intended for self-administration of medication by patients without formal medical training. For example, patients suffering from diabetes or those undergoing artificial insemination procedures may require repeated injections of insulin or hormones. Other patients may require regular injections of other types of medication, such as growth hormones. Therefore, drug delivery devices for self-administration typically include multiple automatic functions and protective features. For example, drug delivery member guards are commonly used. The drug delivery member guard is configured to cover the drug delivery member, e.g., the injection needle, to prevent a user from accidentally coming into contact with the drug delivery member.

[0003] The medication delivery member guard is typically arranged to be telescopically movable relative to the housing of the medication delivery device. The medication delivery member guard is configured to come into contact with a medication delivery site. A medication delivery device configured to be triggered by movement of the medication delivery member guard, for example, to insert an injection needle into the medication delivery site and / or to release a contained medication into the medication delivery site, for example, when the medication delivery member guard is fully pressed against the medication delivery site, or when the medication delivery member guard is fully pressed against the medication delivery site and a button is manually pressed by a user, is a preferred solution on the market. However, there is still room for improvement in such designs. Summary of the Invention

[0004] The invention is defined by the appended claims, to which reference should be made below.

[0005] In the present disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the drug delivery device. When the term "distal portion / distal end" is used, it refers to the portion / end of the delivery device, or a portion / end of a member thereof, that is located furthest from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal portion / proximal end" is used, it refers to the portion / end of the delivery device, or a portion / end of a member thereof, that is located closest to the dose delivery site during use of the drug delivery device.

[0006] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction extending from the proximal end to the distal end, typically along the device or its components, in the direction of the longest extension of the device and / or components.

[0007] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0008] Additionally, the terms "circumference," "circumferential," or "circumferentially" refer to the circumference or direction of circumference relative to an axis, typically a central axis extending in the direction of greatest extension of the device and / or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to an axis, and "rotation," "rotational," and "rotationally" refer to rotation relative to an axis.

[0009] Thus, there is provided a subassembly for a medication delivery device, the subassembly including: a housing extending along a longitudinal axis between a proximal end and a distal end, the housing configured to accommodate a medication container, the medication container coupled to a medication delivery member including an outer portion for delivering the medication, the outer portion of the medication delivery member configured to extend beyond the proximal end of the housing in the direction of the longitudinal axis; and a delivery member guard partially disposed within the housing, the delivery member guard being telescopic relative to the proximal end of the housing, the delivery member guard being movable along the longitudinal axis between an extended position in which the delivery member guard is configured to completely surround the outer portion of the medication delivery member of the medication container and a retracted position in which the delivery member guard is configured to partially surround the outer portion of the medication delivery member of the medication container, the proximal end of the delivery member guard being configured to extend beyond the proximal end of the housing when the delivery member guard is in the retracted position.

[0010] Preferably, according to another embodiment, when the delivery member guard is in the retracted position, the length measured along the longitudinal axis from the proximal end of the delivery member guard to the proximal end of the housing is at least 2 mm.

[0011] Preferably, according to another embodiment, when the delivery member guard is in the retracted position, the length measured along the longitudinal axis from the proximal end of the delivery member guard to the proximal end of the housing is between 3 mm and 6 mm.

[0012] Preferably, according to another embodiment, when the delivery member guard is in the retracted position, the length measured along the longitudinal axis from the proximal end of the delivery member guard to the proximal end of the housing is 3 mm, 3.3 mm, or 3.9 mm.

[0013] Preferably, according to another embodiment, the contact section includes a contact surface perpendicular to the longitudinal axis and an adjacent sleeve extending from the contact surface in the direction of the longitudinal axis towards the distal end of the housing.

[0014] Preferably, according to another embodiment, the delivery member guard includes a contact section configured to contact the agent delivery site.

[0015] Preferably, according to another embodiment, the contact section includes a contact surface perpendicular to the longitudinal axis and an adjacent sleeve extending from the contact surface in the direction of the longitudinal axis towards the distal end of the housing.

[0016] Preferably, according to another embodiment, the contact surface extends beyond the adjacent sleeve in a direction transverse to the longitudinal axis.

[0017] Preferably, according to another embodiment, the delivery member guard includes a proximal tubular section that extends beyond the proximal end of the housing when the delivery member guard is in the extended position.

[0018] Preferably, according to another embodiment, the length of the proximal tubular section measured along the longitudinal axis is between 14 mm and 18 mm from the proximal end of the delivery member guard 2 to the proximal end of the housing.

[0019] Preferably, according to another embodiment, the subassembly of the medication delivery device includes a drive mechanism including a power source.

[0020] Preferably, according to another embodiment, when the power source is released, the power source is configured to act on the medicament container to cause the contained medicament to be released via the medicament delivery member.

[0021] Preferably, according to another embodiment, the drive mechanism is arranged within the housing.

[0022] Preferably, according to another embodiment, the power source can only be released when the delivery member guard is in the retracted position.

[0023] Preferably, according to another embodiment, the power source is configured to be released by the delivery member guard when the delivery member guard is moved to the retracted position.

[0024] Preferably, according to another embodiment, the medication delivery device subassembly includes a button extending outwardly from the housing.

[0025] Preferably, according to another embodiment, the power source is configured to be released when the button is moved towards the housing and the delivery member guard is in the retracted position.

[0026] Preferably, according to another embodiment, the drive mechanism includes a plunger rod configured to be moved into the medication container.

[0027] Preferably, according to another embodiment, the power source is a spring engaged with the plunger rod.

[0028] Preferably, according to another embodiment, the spring is configured to move the plunger rod into the medication container when the spring is released.

[0029] Preferably, according to another embodiment, the drive mechanism includes a rotor rotatable about the longitudinal axis between a first position in which the rotor is coupled to the plunger rod such that the plunger rod is immovable axially relative to the rotor, and a second position in which the rotor is decoupled from the plunger rod such that the plunger rod is moved axially by the power source.

[0030] Preferably, according to another embodiment, the rotor includes a chamfered surface.

[0031] Preferably, according to another embodiment, the delivery member guard includes an interaction surface configured to be moved along a chamfered surface of the rotor when the delivery member guard is moved from an extended position to a retracted position such that the rotor is moved from a first position to a second position.

[0032] Preferably, according to another embodiment, the drive mechanism includes an actuator sleeve that is axially movable relative to the housing between a proximal position in which the actuator sleeve is coupled to the plunger rod so that the plunger rod is immovable axially relative to the actuator sleeve, and a second position in which the actuator sleeve is decoupled from the plunger rod so that the plunger rod can be moved axially by a power source.

[0033] Preferably, according to another embodiment, the actuator sleeve includes a proximally facing surface that engages with a distally facing surface of the delivery member guard, and when the delivery member guard is moved from the extended position to the retracted position, the actuator sleeve is moved from the first position to the second position by the delivery member guard.

[0034] Preferably, according to another embodiment, the delivery member guard is biased against the proximal end of the housing by a biasing member.

[0035] Preferably, according to another embodiment, the biasing member is a spring.

[0036] The subassembly can be used in a drug delivery device that is an injection device, an inhalation device, or a medical nebulizer.

[0037] Preferably, according to another embodiment, the medication delivery device is an auto-injector.

[0038] Preferably, according to another embodiment, the medication delivery device is a handheld pen-type autoinjector.

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

[0040] Preferably, according to another embodiment, the drug delivery comprises a drug delivery member, the drug delivery member being a syringe needle.

[0041] Preferably, according to another embodiment, the length measured along the longitudinal axis L from the proximal tip of the injection needle to the proximal end of the delivery member guard when the delivery member guard is in the retracted position is between 4 mm and 12 mm, preferably 6 mm, 8 mm, or 10 mm.

[0042] Preferably, according to another embodiment, the drug container of the drug delivery device is a syringe, a cartridge or a collapsible bag.

[0043] Preferably, according to another embodiment, the drug container of the drug delivery device is made of glass or plastic material.

[0044] Preferably, according to another embodiment, the drug container of the drug delivery device includes a single chamber containing a single type of drug substance.

[0045] Alternatively, according to another embodiment, the drug container of the drug delivery device includes multiple chambers that respectively house multiple substances.

[0046] The drug delivery devices described herein can be used to treat and / or prevent one or more of many different types of disorders. Exemplary disorders include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraines, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary drug types that can be included in the drug 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 analogs, protein variants, protein precursors, chimeric antigen receptor T-cell therapy, cell or gene therapy, oncolytic viruses, or immunotherapies and / or protein derivatives.Exemplary drugs that may be included in the drug delivery devices described herein include etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), and steroids. inflammatory bowel disease), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel disease) Diseases (e.g., Crohn's disease and ulcerative colitis), ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab-mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin , cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab (non-limiting examples of associated disorders are in parentheses). Pharmaceutical formulations comprising any of the drugs described herein, for example, a pharmaceutical formulation comprising a drug listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier, are also contemplated for use in the drug delivery devices described herein.Pharmaceutical formulations containing the drugs listed herein (or pharmaceutically acceptable salts of the drugs) may contain one or more other active ingredients, or may be the only active ingredient present.

[0047] Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology agents such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.

[0048] Exemplary drugs that may be included in the drug delivery devices described herein include 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 OX40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapy or TCR therapy.

[0049] Exemplary drugs that may be included in the drug delivery devices described herein include AC, high-dose 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, high-dose 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 These include, but are not limited to, multidrug treatment regimens such as 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.

[0050] Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to, those used in chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapy drugs include, by way of example only, 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.

[0051] Furthermore, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless expressly defined otherwise herein. All references to "a / an / the element, device, component, means, etc." should be interpreted broadly as referring to at least one instance of the element, device, component, means, etc., unless expressly stated otherwise. [Brief explanation of the drawings]

[0052] [Figure 1] 1A-1C show subassemblies of a drug delivery device. [Figure 2] 1A-1D illustrate subassemblies of a prior art drug delivery device. [Figure 3A] 1A-1D illustrate subassemblies of a prior art drug delivery device. [Figure 3B] 1A-1D illustrate subassemblies of a prior art drug delivery device. [Figure 4A]1A-1C show subassemblies of a drug delivery device. [Figure 4B] 1A-1C show subassemblies of a drug delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0053] Medication delivery devices typically include a housing for containing a medication container containing a pre-filled medication. The housing is generally tubular. A delivery member guard is typically used in medication delivery devices. The delivery member guard is configured to cover the medication delivery member, e.g., a syringe needle, to prevent a user from accidentally coming into contact with the medication delivery member.

[0054] The delivery member guard is typically arranged to be telescopically movable relative to the housing of the medication delivery device. The delivery member guard is configured to come into contact with the medication delivery site. A medication delivery device configured to be triggered by the movement of the delivery member guard, for example, to automatically insert an injection needle into the medication delivery site and / or release a contained medication into the medication delivery site, is preferably a solution on the market, for example, when the medication delivery member guard is fully pressed against the medication delivery site or when it is pressed and moved a certain distance (the expression "the medication delivery member guard is fully pressed" means that the medication delivery member guard cannot move further toward the distal end of the housing of the medication delivery device), or when the delivery member guard is fully pressed against the medication delivery site or when it is pressed a certain distance and a button is manually pressed by a user. However, in some cases, a user may think that they have followed instructions for correctly operating the medication delivery device, but the device is not triggered on the first try, or a perceived large force is required to trigger the medication delivery device. One reason may be an obstacle to the movement of the delivery member guard. For example, excessive skin contacts the housing of the drug delivery device, making it difficult or impossible for the delivery member guard to move to the trigger position (the position where the drug delivery device is triggered or the button is pressed). As a result, the user may be unable to complete the triggering operation or the triggering force may be high. One reason for this problem may be that the delivery member guard is designed to be close to the housing. For example, when the delivery member guard is pressed to trigger the drug delivery operation, the length X2 measured along the longitudinal axis L from the proximal end of the delivery member guard to the proximal end of the housing is generally about 1 mm or less. Therefore, there is a risk that the skin around the drug delivery site may be trapped between the proximal end of the delivery member guard and the proximal end of the housing. In one preferred example, the delivery member guard is configured to move 10 mm to 15 mm distally relative to the housing to the trigger position.Preferably, for subcutaneous injections, the delivery member guard is configured to move distally relative to the housing to the trigger position 12.05 mm + / - 10%, depending on engineering tolerances. Note that the distance may be modified for different needle lengths or predetermined injection depths.

[0055] It should be noted that most medication delivery devices are designed with a range of trigger travel. That is, instead of designing a medication delivery device to be triggered when the medication delivery member guard is fully pressed against the medication delivery site, the medication delivery device is typically designed to be triggered when the medication delivery member guard is moved a range of distances. For example, if the medication delivery member guard is designed to reach the "fully pressed" position by moving 13 mm toward the medication delivery device housing, the medication delivery device is typically designed to be triggered when the medication delivery member guard is moved 12 mm to 13 mm toward the medication delivery device housing to resolve any potential engineering tolerance issues.

[0056] A preferred solution is to keep the housing away from the drug delivery site during triggering (the term "triggering" means that the user manually moves the delivery member guard toward the distal end of the housing to the trigger position of the delivery member guard) to reduce frictional forces between the delivery member guard, the skin, and the housing. A more preferred solution is to keep the housing more than 2 mm away from the drug delivery site during triggering.

[0057] 1 and 4A-4B show a subassembly of a drug delivery device of the present invention. The drug delivery device subassembly includes a housing 1, 1' extending along a longitudinal axis L between a proximal end and a distal end. The housing 1 is configured to accommodate a drug container. In a preferred embodiment, the housing 1 is tubular. The drug container is coupled to a drug delivery member N including an outer portion for delivering a drug. The outer portion of the drug delivery member is configured to extend beyond the proximal end of the housing in the direction of the longitudinal axis to contact a drug delivery site, and a drug contained in the drug container can be delivered through the outer portion of the drug delivery member. In a preferred embodiment, the drug delivery member is an injection needle N, as shown in FIGS. 4A-4B. In this example, the outer portion of the drug delivery member is the portion of the injection needle exposed to the user and configured to be at least partially inserted into an injection site. The length of the proximal portion of the injection needle, measured along the longitudinal axis from the proximal end of the drug container, e.g., a syringe, depends on the intended injection. For example, the length of the proximal portion of the needle is typically 12.7 mm to 15.875 mm for subcutaneous injections and 25 mm to 38 mm for intramuscular injections. The effective injection depth is provided by the outer portion of the needle, as it extends beyond the proximal end of the housing 1. The length of the outer portion of the needle is measured along the longitudinal axis L from the proximal tip of the needle to the proximal end of the housing. The length of the proximal portion of the needle defines the maximum length of the outer portion of the needle.

[0058] The medication delivery device subassembly includes a delivery member guard 2, 2' partially disposed within the housing 1, 1'. The delivery member guard 2, 2' is telescopic relative to the proximal end of the housing 1, 1'. The delivery member guard 2, 2' is movable along a longitudinal axis L between an extended position (shown in FIG. 4A ) in which the delivery member guard 2, 2' is configured to completely surround an outer portion of the medication delivery member N of the medication container, and a retracted position (shown in FIGS. 1 and 4B ) in which the delivery member guard 2, 2' is configured to partially surround the outer portion of the medication delivery member N of the medication container. The delivery member guard 2' includes a proximal tubular section 20 configured to completely surround the outer portion of the medication delivery member N of the medication container when the delivery member guard 2' is in the extended position and to partially surround the outer portion of the medication delivery member N of the medication container when the delivery member guard 2' is in the retracted position. In a preferred example, the proximal tubular section 20 of the delivery member guard 2' is coaxial with the housing 1'.

[0059] The proximal end of the delivery member guard 2, 2' is configured to extend beyond the proximal end of the housing 1, 1' when the delivery member guard 2, 2' is in the retracted position. In a preferred example, the proximal tubular section 20 of the delivery member guard 2 extends from the proximal end of the delivery member guard 2 to the proximal end of the housing 1 when the delivery member guard 2 is in the extended position.

[0060] In one example where the drug delivery member N is an injection needle N, the delivery member guard 2, 2' is configured to completely surround an outer portion of the injection needle N of the drug container when the delivery member guard 2, 2' is in the extended position, and is configured to partially surround an outer portion of the drug delivery member N of the drug container when the delivery member guard 2, 2' is in the retracted position.

[0061] The effective injection depth is defined by the length X3 measured along the longitudinal axis L from the proximal tip of the injection needle N to the proximal end of the delivery member guard 2' when the delivery member guard 2' is in the retracted position. In preferred examples, the effective injection depth is between 4 mm and 12 mm, preferably 6 mm, 8 mm, or 10 mm.

[0062] In one example, the housing 1, 1' is shortened so that a greater portion of the delivery member guard 2, 2' is exposed from the proximal end of the housing 1, 1'. Alternatively, in another example, the delivery member guard is elongated so that a greater portion of the delivery member guard is exposed from the proximal end of the housing. Thus, the distance between the proximal end of the delivery member guard and the proximal end of the housing can be extended when the delivery member guard is in the retracted position, and the skin contact area of ​​the housing can be reduced, as shown in Figures 1-2 and 3B and 4B. As a result, this design can reduce the force required to trigger the drug delivery device subassembly by moving the delivery member guard from the extended position to the retracted position. In one preferred example, the housing 1, 1' is configured to be spaced more than 2 mm from the drug delivery site during triggering, i.e., when the delivery member guard 2, 2' is in the retracted position, the length X1 measured along the longitudinal axis L from the proximal end of the delivery member guard 2, 2' to the proximal end of the housing 1, 1' is at least 2 mm.

[0063] Because the proximal tubular section 20 of the delivery member guard 2' is configured to surround the outer portion of the needle N of the medication container to prevent the user from accidentally touching the needle, if the length X1 measured along the longitudinal axis L from the proximal end of the delivery member guard 2, 2' to the proximal end of the housing 1, 1' when the delivery member guard 2, 2' is in the retracted position is long, the proximal tubular section 20 must also be long, which may increase the material cost of the medication delivery device. Therefore, in a preferred example, the length X1 measured along the longitudinal axis L from the proximal end of the delivery member guard 2 to the proximal end of the housing 1 is 3 mm to 6 mm when the delivery member guard is in the retracted position. In a preferred example, the length X1 measured along the longitudinal axis L from the proximal end of the delivery member guard 2 to the proximal end of the housing 1 is 3 mm, 3.3 mm, or 3.9 mm when the delivery member guard 2, 2' is in the retracted position.

[0064] Because the proximal end of the delivery member guard 2, 2' is configured to contact the drug delivery site, the subassembly disclosed above provides a length X1 measured along the longitudinal axis L from the proximal end of the delivery member guard 2, 2' to the proximal end of the housing 1, 1' that is greater than 2 mm, which can keep the housing 1, 1' away from the drug delivery site during triggering and reduce frictional forces between the delivery member guard 2, 2', the skin and the housing 1, 1'.

[0065] In one example, the delivery member guard 2' includes contact sections 20a, 20b configured to contact the drug delivery site. In another example, the contact sections 20a, 20b are spaced from the proximal end of the housing 1'. In one example, the contact sections 20a, 20b include a contact surface 20a perpendicular to the longitudinal axis L and an adjacent sleeve 20b extending from the contact surface 20a in the direction of the longitudinal axis L toward the distal end of the housing 1'. In one example, the contact surface 20a is at the proximal end of the delivery member guard 2'. In a preferred example, the contact surface 20a extends beyond the adjacent sleeve 20b in a direction transverse to the longitudinal axis L, as shown in Figures 4A-4B. The contact surface 20a is configured to prevent skin tissue from becoming trapped between the housing 1' and the delivery member guard 2'.

[0066] Furthermore, as described above, the effective injection depth is defined by the length X3 measured along the longitudinal axis L from the proximal tip of the injection needle N to the proximal end of the delivery member guard 2' when the delivery member guard 2' is in the retracted position. Thus, in a preferred example, the length of the proximal tubular section 20 of the delivery member guard 2' is greater than the effective injection depth plus the length X1 measured along the longitudinal axis L from the proximal end of the delivery member guard 2 to the proximal end of the housing 1. In one preferred example, the length of the proximal tubular section 20 of the delivery member guard 2' measured along the longitudinal axis L is between 14 mm and 18 mm when the delivery member guard 2' is in the extended position.

[0067] In a preferred example, the effective injection depth is between 4 mm and 12 mm, preferably 6 mm, 8 mm, or 10 mm.

[0068] In one example, the delivery member guard 2' is biased towards the proximal end of the housing 1 by a biasing member 4. In a preferred example, the biasing member is a spring, for example a compression spring, an extension spring, a torsion spring, or a flexible arm.

[0069] In one example, the medication delivery device subassembly includes a drive mechanism including a power source. When the power source is released, the power source is configured to act on the medication container and release the stored medication through the medication delivery member. The drive mechanism is disposed within the housing. The power source can be released only when the delivery member guard is in the retracted position. In one example, the power source is configured to be released by the delivery member guard when the delivery member guard is in the retracted position. In another example, the medication delivery device subassembly includes a button 3 extending outward from the housing 1. In one preferred example, the button 3 extends from the distal end of the housing 1, as shown in FIG. 1 . The power source is configured to be released when the button is moved toward the housing and the delivery member guard is in the retracted position.

[0070] In one example, the drive mechanism includes a plunger rod connected to a power source, the plunger rod configured to be moved by the power source into the medication container when the power source is released.

[0071] In one example, the power source is a spring, compression spring, torsion spring, or constant force band spring engaged with the plunger rod. The spring is configured to move the plunger rod into the medication container when the spring is released. Alternatively, the power source can be a gas canister containing pressurized gas or a motor.

[0072] In one example, the drive mechanism includes a rotor rotatable about a longitudinal axis between a first position in which the rotor is coupled to the plunger rod such that the plunger rod is immovable axially relative to the rotor, and a second position in which the rotor is decoupled from the plunger rod such that the plunger rod is moved axially by a spring. In this example, the rotor is immovable relative to the housing in the direction of the longitudinal axis L. In a preferred example, the rotor includes a chamfered surface. The delivery member guard includes an interaction surface configured to move along the chamfered surface of the rotor when the delivery member guard is moved from the extended position to the retracted position so that the rotor is moved from the first position to the second position.

[0073] In one example, the rotor includes a tubular body extending along the longitudinal axis L. In one example, the rotor includes a ledge extending from the tubular body of the rotor toward the longitudinal axis L. The ledge of the rotor is engaged with a proximally facing surface of the plunger rod when the rotor is in a first position, and the ledge of the rotor is disengaged from the proximally facing surface of the plunger rod when the rotor is in a second position. In another example, the housing includes an inner housing positioned between the plunger rod and the rotor in a direction transverse to the longitudinal axis L. In this example, the inner housing includes a flexible arm including a distally facing surface that is engaged with the proximally facing surface of the plunger rod. In this example, the tubular body of the rotor includes a support wall configured to align with the flexible arm of the inner housing when the rotor is in the first position, preventing the flexible arm from deflecting radially outward. As a result, when the rotor is in the first position, the distally facing surfaces of the flexible arms engage the proximally facing surfaces of the plunger rod. When the rotor is in the second position, the support walls of the rotor are circumferentially offset from the flexible arms, allowing the flexible arms to flex radially outward. As a result, when the rotor is in the second position, the distally facing surfaces of the flexible arms are moved radially away from and disengaged from the proximally facing surfaces of the plunger rod.

[0074] Alternatively, the drive mechanism includes an actuator sleeve axially movable relative to the housing between a proximal position in which the actuator sleeve is coupled to the plunger rod such that the plunger rod is immovable axially relative to the actuator sleeve and a second position in which the actuator sleeve is decoupled from the plunger rod such that the plunger rod is moved axially by the power source. The actuator sleeve includes a proximally facing surface that engages a distally facing surface of the delivery member guard, and the actuator sleeve is moved from the first position to the second position by the delivery member guard when the delivery member guard is moved from the extended position to the retracted position.

[0075] In one example, the subassembly includes an actuator positioned between the plunger rod and the actuator sleeve transverse to the longitudinal axis L. In this example, the actuator includes a flexible arm including a distally facing surface that engages with a proximally facing surface of the plunger rod. In this example, the actuator sleeve includes a support wall configured to align with the flexible arm of the actuator when the actuator sleeve is in a first position, preventing the flexible arm from deflecting radially outward. As a result, when the actuator sleeve is in the first position, the distally facing surface of the flexible arm engages the proximally facing surface of the plunger rod. The support wall of the actuator sleeve is axially offset from the flexible arm when the actuator sleeve is in a second position, allowing the flexible arm to deflect radially outward. As a result, when the actuator sleeve is in the second position, the distally facing surface of the flexible arm is moved radially away from the proximally facing surface of the plunger rod and disengaged.

[0076] Further, in one example, the subassembly of the medication delivery device includes a button. In one example, the button is connected to the plunger rod. In this example, the plunger rod can be pushed to separate from the actuator sleeve by being moved by the button toward the proximal end of the housing only when the actuator sleeve is in the second position. Alternatively, in one example where the subassembly includes an actuator, the button is connected to the actuator. In this example, the actuator can be pushed to separate from the actuator sleeve by being moved by the button toward the proximal end of the housing only when the actuator is in the second position.

[0077] In one example where the power source is a compression spring, the spring extends along a longitudinal axis L between the plunger rod and the actuator.

[0078] Additionally, several other mechanisms by which subassemblies of a medication delivery device are triggered by moving a delivery member guard from an extended position to a retracted position and / or by moving a delivery member guard from an extended position to a retracted position and pressing a button toward the housing are described in commonly assigned U.S. Patent Nos. 7,442,185, 7,597,685, 20120123350, 8,414,533 and 9,199,038 (the disclosures of which are incorporated herein by reference).

[0079] The present disclosure further provides a medication delivery device comprising a medication delivery device subassembly as disclosed in any one of the above examples. In one example, the medication delivery device is an auto-injector.

[0080] Additionally, the housing may be provided with (i.e., molded within or with) a compound characterized by persistent antibacterial, antifungal, and / or antiviral properties, as described in any of the examples. Alternatively, the compound characterized by persistent antibacterial, antifungal, and / or antiviral properties may be applied to the molded (i.e., finished) component by a secondary process (e.g., chemical vapor deposition), spraying, or dipping process.

[0081] The inventive concept has been described primarily with reference to a few examples. However, as those skilled in the art will readily appreciate, other embodiments than those disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims.

Claims

1. 1. A subassembly of a medication delivery device, comprising: a housing (1, 1') extending along a longitudinal axis (L) between a proximal end and a distal end, the housing (1, 1') configured to accommodate a medicament container, the medicament container being coupled to a medicament delivery member (N) including an outer portion for delivering a medicament, the outer portion of the medicament delivery member (N) configured to extend beyond the proximal end of the housing in the direction of the longitudinal axis (L); a delivery member guard (2, 2') partially disposed within the housing (1, 1'), the delivery member guard being telescopic relative to the proximal end of the housing, the delivery member guard being movable along the longitudinal axis between an extended position in which the delivery member guard is configured to completely surround the outer portion of the drug delivery member of the drug container and a retracted position in which the delivery member guard is configured to partially surround the outer portion of the drug delivery member of the drug container, the proximal end of the delivery member guard being configured to extend beyond the proximal end of the housing (1, 1') when the delivery member guard is in the retracted position.

2. 2. The subassembly of claim 1, wherein when the delivery member guard is in the retracted position, a length measured along the longitudinal axis from the proximal end of the delivery member guard to the proximal end of the housing is at least 2 mm.

3. 3. The subassembly of claim 2, wherein when the delivery member guard is in the retracted position, the length measured along the longitudinal axis from the proximal end of the delivery member guard to the proximal end of the housing is between 3 mm and 6 mm.

4. 4. The subassembly of claim 3, wherein when the delivery member guard is in the retracted position, the length measured along the longitudinal axis from the proximal end of the delivery member guard to the proximal end of the housing is 3 mm, 3.3 mm, or 3.9 mm.

5. 5. The subassembly of claim 1, wherein the delivery member guard includes a contact section configured to contact a drug delivery site, the contact section including a contact surface perpendicular to the longitudinal axis and an adjacent sleeve extending from the contact surface in the direction of the longitudinal axis toward the distal end of the housing, the contact surface extending beyond the adjacent sleeve in a direction transverse to the longitudinal axis.

6. A subassembly according to any one of claims 1 to 5, wherein the delivery member guard includes a proximal tubular section that extends beyond the proximal end of the housing when the delivery member guard is in the extended position, and the length of the proximal tubular section measured along the longitudinal axis from the proximal end of the delivery member guard 2 to the proximal end of the housing 1 is between 14 mm and 18 mm.

7. the subassembly of the medication delivery device includes a drive mechanism including a power source configured to act on the medication container to expel the contained medication through the medication delivery member when the power source is released, the drive mechanism being disposed within the housing; A subassembly according to any preceding claim, wherein the power source can be released only when the delivery member guard is in the retracted position.

8. The subassembly of claim 7 , wherein the power source is configured to be released by the delivery member guard when the delivery member guard is moved to the retracted position.

9. 8. The subassembly of claim 7, wherein the subassembly of the medication delivery device includes a button (3) extending from the housing, and the power source is configured to be released when the button is moved toward the housing and the delivery member guard is in the retracted position.

10. 10. The subassembly of claim 7, wherein the drive mechanism includes a plunger rod configured to move into the drug container, and the power source is a spring engaged with the plunger rod, the spring configured to move the plunger rod into the drug container when the spring is released.

11. 11. The subassembly of claim 10, wherein the drive mechanism includes an actuator sleeve axially movable relative to the housing between a proximal position in which the actuator sleeve is coupled to the plunger rod such that the plunger rod is immovable axially relative to the actuator sleeve, and a second position in which the actuator sleeve is decoupled from the plunger rod such that the plunger rod is moved axially by the spring, the actuator sleeve including a proximally facing surface that engages a distally facing surface of the delivery member guard such that the actuator sleeve is moved from the first position to the second position by the delivery member guard when the delivery member guard is moved from the extended position to the retracted position.

12. A drug delivery device comprising a subassembly according to any one of claims 1 to 11.

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