WO2024094439A1

WO2024094439A1 - A sub-assembly of a medicament delivery device

Info

Publication number: WO2024094439A1
Application number: PCT/EP2023/079217
Authority: WO
Inventors: Munib BABER; Johan Zander
Original assignee: Shl Medical Ag
Priority date: 2022-11-04
Filing date: 2023-10-20
Publication date: 2024-05-10

Abstract

A sub-assembly of a medicament delivery device, the sub-assembly comprising: a tubular housing, a delivery member guard arranged coaxially with the tubular housing, a biasing member configured to bias the delivery member guard relative to the housing from a distal position to a proximal position, a cap removably attached to the proximal end of the housing, a connector, and an adapter operably connected to the delivery member guard such that the adapter is axially immovable relative to the delivery member guard when the delivery member guard is in the distal position; wherein the adapter comprises a proximally directed surface. The connector is rotatable around the longitudinal axis relative to the adapter between a first position where the distally directed surface of the connector is adjacent to the proximally directed surface of the adapter such that the proximal portion of the delivery member guard is blocked from being biased to the proximal position and a second position where the distally directed surface of the connector is offset relative to the proximally directed surface of the adapter such that the proximal portion of the delivery member guard can be biased to the proximal position by the biasing member.

Description

TITLE

A sub-assembly of a medicament delivery device.

TECHNICAL FIELD

The present disclosure generally relates to a sub-assembly of a medicament delivery device, and particularly to a sub-assembly of a medicament delivery device comprising a connector and an adapter.

BACKGROUND

Medicament delivery devices such as pen-type manual injectors or auto-injectors are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes may require repeated injections of insulin, or patients may require regular injections of other types of medicaments, such as growth hormones.

It is an advantage when the medicament delivery devices for self-administration comprise automatic functions so that even if users are without professional training or are in an emergency situation, the users can easily and properly use the medicament delivery devices.

Even though many of the devices on the market, as well as the ones described above, have their respective advantages, there is still room for improvement.

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” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component. 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 sub-assembly of a medicament delivery device. The subassembly comprises a tubular housing extending along a longitudinal axis between a proximal end and a distal end. A delivery member guard comprises a proximal portion arranged coaxially with the tubular housing. The proximal portion is configured to surround a medicament delivery member of the medicament delivery device. The biasing member is operably attached to the housing at one end and to the delivery member guard at the other end. The biasing member is configured to bias the delivery member guard relative to the housing from a distal position to a proximal position. A cap is removably attached to the proximal end of the housing. The cap comprises a distally directed surface. A connector comprises a proximally directed surface operably engaged with the distally directed surface of the cap and comprises a distally directed surface. An adapter is operably connected to the delivery member guard such that the adapter is axially immovable relative to the delivery member guard when the delivery member guard is in the distal position. The adapter comprises a proximally directed surface. The connector is rotatable around the longitudinal axis relative to the adapter between a first position where the distally directed surface of the connector is engaged with the proximally directed surface of the adapter such that the proximal portion of the delivery member guard is blocked from being biased to the proximal position and a second position where the distally directed surface of the connector is disengaged with the proximally directed surface of the adapter such that the proximal portion of the delivery member guard can be biased to the proximal position by the biasing member.

Preferably, according to another embodiment, the adapter comprises a ledge extending from a wall of the proximal portion of the delivery member guard.

Preferably, according to another embodiment, the ledge comprises the proximally directed surface of the adapter.

Alternatively, according to another embodiment, the adapter comprises a ring-shaped body.

Preferably, according to another embodiment, the adapter comprises a ledge extending from an inner surface of the ring-shaped body. Preferably, according to another embodiment, the ring-shaped body comprises a distally directed surface.

Preferably, according to another embodiment, the proximal portion of the delivery member guard comprises a proximally directed surface engaged with the distally directed surface of the ring-shaped body.

Preferably, according to another embodiment, the adapter comprises an engaging member and the housing comprises a counter engaging member engaged with the engaging member such that the adapter is rotationally immovable relative to the housing when the delivery member guard is in the distal position.

Preferably, according to another embodiment, the engaging member and the counter engaging member form at least one of a rib-and-rib engagement, a rib-and-recess engagement, and a rib-and-cut-out engagement.

Alternatively, according to another embodiment, the adapter comprises an engaging member and the cap comprises a counter engaging member engaged with the engaging member such that the adapter is rotationally immovable relative to the cap when the delivery member guard is in the distal position.

Preferably, according to another embodiment, the engaging member comprises a noncircular cross-section perpendicular to the longitudinal axis, and the counter engaging member comprises a counter non-circular cross-section perpendicular to the longitudinal axis.

Preferably, according to another embodiment, the engaging member of the adapter is an inner circumferential surface of the ring-shaped body of the adapter.

Preferably, according to another embodiment, the connector comprises a body. The connector comprises a ledge extending from an inner surface of the body of the connector towards the longitudinal axis.

Preferably, according to another embodiment, the ledge comprises the distally directed surface of the connector.

Preferably, according to another embodiment, the body of the connector is the ring-shaped body.

Preferably, according to another embodiment, the sub-assembly comprises a delivery member cover assembly. Preferably, according to another embodiment, the delivery member cover assembly comprises a tubular outer cap and a clutch member.

Preferably, according to another embodiment, the cap is at least partially surrounded by the tubular outer cap.

Preferably, according to another embodiment, the clutch member is rotationally fixed to the cap and positioned longitudinally between the tubular outer cap and the delivery member guard.

Preferably, according to another embodiment, the clutch member comprises a clutch biasing member, the clutch member being axially movable relative to the outer cap from a relaxed position to a tensioned position when the delivery member guard is moved from the distal position to the proximal position.

Preferably, according to another embodiment, the tubular outer cap is axially fixed with and rotatable relative to the cap.

Preferably, according to another embodiment, the tubular outer cap comprises an engaging member and the clutch member comprises a counter engaging member. Preferably, according to another embodiment, the engaging member is adjacent to the counter engaging member when the clutch biasing member is in the relaxed position.

Preferably, according to another embodiment, the connector is the tubular outer cap.

Preferably, according to another embodiment, the connector is positioned longitudinally between the tubular outer cap and the delivery member guard and is positioned at least partially between the tubular outer cap and the clutch member.

Preferably, according to another embodiment, the connector is rotatable relative to the clutch member.

Preferably, according to another embodiment, the connector comprises a rotational engaging member. The outer cap comprises a counter rotational engaging member adjacent to the rotational engaging member such that the connector is manually rotated from the first position to the second position via a rotation of the tubular outer cap relative to the cap.

Preferably, according to another embodiment, the engaging member of the tubular outer cap is the counter rotational engaging member.

Preferably, according to another embodiment, the rotational engaging member of the connector is a counter protrusion. The rotational engaging member and the counter rotational engaging member form a ratchet engagement such that the connector is only rotationally fixed to the tubular outer cap in one rotational direction.

Preferably, according to another embodiment, the clutch member comprises a proximal portion and a distal portion. The clutch biasing member is longitudinally positioned between the proximal portion and the distal portion. The proximal portion is releasably engaged with a distally directed surface on the inner surface of the tubular outer cap.

Preferably, according to another embodiment, the adapter is the distal portion of the clutch member.

Preferably, according to another embodiment, the counter engaging members of the clutch member is a counter protrusion. The counter protrusion extends radially outwardly relative to the longitudinal axis from an outer surface of the cap.

Preferably, according to another embodiment, the counter engaging member of the clutch member is arranged on an outer surface of the distal portion.

Preferably, according to another embodiment, the counter engaging member comprises a flexible arm extending partially around the longitudinal axis.

Preferably, according to another embodiment, the delivery member guard is partially arranged within the housing.

Preferably, according to another embodiment, the tubular proximal portion of the delivery member guard is arranged telescopically relative to the proximal end of the housing.

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

Preferably, according to another embodiment, the housing comprises a proximally directed surface. The delivery member guard comprises a distally directed surface.

Preferably, according to another embodiment, the spring extends between a first end engaged with the proximally directed surface of the housing and a second end engaged with the distally directed surface of the delivery member guard.

Preferably, according to another embodiment, the sub-assembly is used in a medicament delivery device comprising a multiple-chamber medicament container arranged within the carrier.

Preferably, according to another embodiment, the medicament container of the medicament delivery device is a syringe, a cartridge or a collapsible bag. Preferably, according to another embodiment, the medicament container of the medicament delivery device is made of glass material or plastic material.

Preferably, according to another embodiment, the medicament delivery device is an injection device, an inhalation device, or a medical sprayer.

Preferably, according to another embodiment, the medicament delivery device is an autoinjector.

Preferably, according to another embodiment, the medicament delivery member is an injection needle or a spray nozzle.

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-1 a (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, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90- Yttrium- ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. 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 bio-oncology 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 TCR 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 schematically shows a perspective view of a sub-assembly of the invention in an initial state;

Fig. 2 schematically shows a perspective view of the sub-assembly of Fig. 1 in a ready-to- be-used state;

Fig. 3 schematically shows a perspective view of another example of the sub-assembly of the invention in an initial state;

Fig. 4 schematically shows a perspective view of the sub-assembly of Fig. 3 in an initial state;

Fig. 5 schematically shows a perspective view of components of the sub-assembly of Fig. 1 . Fig. 6 schematically shows a perspective view of components of the sub-assembly of Fig. 3.

Figs 7A-E schematically show perspective views of an operation sequence of the subassembly of Fig. 1 ;

Figs 8A-B schematically show perspective views of an operation sequence of the subassembly of Fig. 3;

Fig. 9 schematically shows a perspective view of a delivery member guard of the subassembly of the invention and a cap assembly of the sub-assembly of the invention;

Figs 10-11 schematically show perspective views of the cap assembly of Fig. 9;

Fig. 12 schematically shows a perspective view of a cap of the cap assembly of Fig. 9;

Fig. 13 schematically shows a perspective view of a clutch member of the sub-assembly of the invention;

Figs 14-15 schematically show a perspective view of the cap assembly of Fig. 9 with the clutch member of Fig. 13.

DETAILED DESCRIPTION

Figs 1-15 illustrate many examples of a sub-assembly of a medicament delivery device. The sub-assembly comprises a tubular housing 1 ; 1 a delivery member guard 2; 2’, a biasing member, a cap 31 , a connector 5; 5’ and an adapter 6; 6’.

As shown in Figs 1-4, the tubular housing 1 ; 1 ’ extends along a longitudinal axis L between a proximal end and a distal end. The tubular housing 1 ; 1 ' is configured to receive a medicament container of the medicament delivery device. Preferably, the tubular housing 1 ; 1 ' comprises an observation window so that a user of the medicament delivery device can check the condition of the medicament within the medicament container before use. The window can be a transparent portion or an aperture in a wall of the tubular housing 1 ; 1'. Alternatively, the housing can be made of transparent material so that the window is no longer necessary for the user to observe the medicament. In a preferred example, as shown in Figs 2-3, the tubular housing 1 ; 1 ' has a rectangular cross-section perpendicular to the longitudinal axis L, so that the medicament delivery device can be prevented from rolling on a flat surface. It should be noted that such functionality can be obtained by forming the tubular housing 1 ; 1 ' in any shape that has a non-circular cross-section perpendicular to the longitudinal axis L. The tubular housing can be formed by multiple components, or the tubular housing can be formed by a single component, dependent on the design. The delivery member guard 2; 2’ comprises a proximal portion 20; 20’ arranged coaxially with the tubular housing 1 ; 1 ’. The proximal portion 20; 20’ is configured to surround a medicament delivery member of the medicament delivery device. The proximal portion 20; 20’ can be tubular, or it can be formed by multiple proximally extending arms. In a preferred example, the delivery member guard 2; 2’ is partially arranged within the housing. In this example, the tubular proximal portion 20; 20’ of the delivery member guard 2; 2’ is arranged telescopically relative to the proximal end of the housing 1 ; 1 ’, as shown in Figs 1-4. Alternatively, the delivery member guard at least partially surrounds a proximal portion of the tubular housing.

The biasing member is operably attached to the tubular housing 1 ; 1 ’ at one end and to the delivery member guard 2; 2’ at the other end. The biasing member is configured to bias the delivery member guard 2; 2’ relative to the housing from a distal position to a proximal position. The biasing member can be a spring, e.g., a compression spring, a tension spring, a band spring; or a flexible arm. In one example where the biasing member is a spring, the tubular housing 1 comprises a proximally directed surface and the delivery member guard comprises a distally directed surface. In this example, the biasing member extends between a first end that is engaged with the proximally directed surface of the housing, and a second end that is engaged with the distally directed surface of the delivery member guard.

The cap 31 is removably attached to the proximal end of the housing 1 ; 1 '. The cap 31 comprises a distally directed surface 311 . The cap 31 is configured to seal a medicament delivery member, e.g., an injection needle or a spray nozzle, of the medicament delivery device. In a preferred example, the cap 31 is configured to be removed from the housing via a rotation of the cap 31 around the longitudinal axis L of the tubular housing 1 and relative to the tubular housing. In this example, the cap 31 is engaged with the tubular housing 1 via a threaded engagement or a bayonet engagement. Alternatively, the cap is configured to be removed from the tubular housing via a linear movement relative to the housing. For example, the cap is configured to be pulled by a user of the medicament delivery device.

The connector 5; 5’ comprises a proximally directed surface 501 ; 501 ’ operably engaged with the distally directed surface 311 of the cap 31 and comprises a distally directed surface 51 a; 51 a’. Therefore, the connector 5; 5’ is axially immovable relative to the cap 31 in the proximal direction of the tubular housing 1 ; 1 ’.

In a preferred example, the connector 5; 5’ comprises a body. The connector 5’ comprises a ledge 51 ’ extending from an inner surface of the body of the connector 5’ towards the longitudinal axis L, as shown in Fig. 6. The ledge 51 ’ comprises the distally directed surface 51 a’ of the connector 5’. Alternatively, the ledge 51 extends from an outer surface of the body of the connector 5 away from the longitudinal axis, as shown in Fig. 5. The ledge 51 comprises the distally directed surface 51 a of the connector 5.

In one example, the body of the connector 5; 5’ is generally cylindrical. In a preferred example, the body of the connector 5’ is a ring-shaped body.

The adapter 6; 6’ is operably connected to the delivery member guard 2; 2’ such that the adapter s; 6’ is axially immovable relative to the delivery member guard 2; 2’ when the delivery member guard 2; 2 is in the distal position. In one example, the adapter 6; 6’ comprises a distally directed surface engaged with a proximally directed surface of the delivery member guard 2; 2’ directly, as shown in Figs 7A-7D and Fig. 8A. Alternatively, the adapter is an integral part of the proximal portion of the delivery member guard. The adapter 6; 6’ comprises a proximally directed surface 60a; 60a’ engaged with the distally directed surface 51 a; 51 a’ of the connector 5; 5’ when the connector 5; 5’ is in a first position.

Therefore, the delivery member guard 2; 2’ is blocked from moving in the proximal direction relative to the tubular housing 1 . The proximally directed surface 60a; 60a’ of the adapter 6; 6’ is disengaged from the distally directed surface 51 a; 51 a’ of the connector 5; 5’ when the connector 5; 5’ is in a second position such that the proximal portion 20; 20’ of the delivery member guard 2; 2’ can be biased to the proximal position by the biasing member. In one example where the adapter is an integral part of the proximal portion of the delivery member guard, the adapter comprises a ledge extending from a wall of the proximal portion of the delivery member guard. The ledge comprises the proximally directed surface of the adapter.

Alternatively, the adapter 6; 6’ is an independent component separate from the delivery member guard, as shown in Figs 5-6. In a preferred example, the adapter 6; 6’ comprises a ring-shaped body, as shown in Figs 5-6.

It should be noted that the term ‘ring-shaped body’ used in this description means that the body comprises a wall enclosing the longitudinal axis L.

In this example, the ring-shaped body comprises the distally directed surface engaged with the proximally directed surface of the delivery member guard when the delivery member guard is in the distal position. In a preferred example, the distally directed surface of the adapter 6; 6’ is defined by the distal end edge of the ring-shaped body, and the proximal directed surface of the delivery member guard 2; 2’ is defined by the proximal end edge of the proximal portion 20; 20’.

The connector 5; 5' is configured to be rotated relative to the adapter 6; 6 around the longitudinal axis L between the first position and the second position. In one example, the connector 5 is configured to be rotated relative to the tubular housing 1 around the longitudinal axis L between the first position and the second position. Alternatively, the adapter 6' is configured to rotate relative to the tubular housing 1 around the longitudinal axis L between the first position of the connector s' and the second position of the connector 5'.

In one example, the adapter s; 6’ comprises a ledge 60; 60 extending from an inner surface of the ring-shaped body. The ledge comprises the proximally directed surface 60a; 60a’ of the adapter 6; 6’. As shown in Figs 7A and 8A, the proximally directed surface 60a; 60a’ of the adapter s; 6’ is engaged with the distally directed surface 51 a; 51 a’ of the connector 5; 5’ when the connector 5; 5’ is in the first position. When the connector 5; 5’ is rotated around the longitudinal axis L relative to the adapter 6; 6’ into the second position (as shown with the arrow R1), the proximally directed surface 60a; 60a’ of the adapter 6; 6’ is disengaged from the distally directed surface 51 a; 51 a’ of the connector 5; 5’, as shown in Fig 7D and Fig. 8B.

In one example, the proximally directed surface 501 of the connector 5 is directly engaged with the distally directed surface 311 of the cap 31 , as shown in Fig. 8A. Alternatively, the proximally directed surface 501 ' of the connector 5' is indirectly engaged with a tubular outer cap 30 which is engaged with the distally directed surface 311 of the cap 31 , as shown in Fig. 7A. With the mentioned engagement between the cap 31 and the connector 5; 5’, when the connector 5; 5’ is in the first position, the delivery member guard 2; 2’ is prevented from moving in the proximal direction relative to the tubular housing 1 .

In one example, the connector 5 is accessible to the user of the medicament delivery device, as shown in Figs 1-2. In this example, the connector 5 is the tubular outer cap 30 of the medicament delivery device. In this example, the connector 5 is configured to be manually rotated by the user from the first position to the second position when the user plans to use the medicament delivery device.

As shown in Fig. 2, when the user rotates the connector 5 to the second position, as the proximally directed surface 60a of the adapter 6 is disengaged from the distally directed surface 51 a of the connector 5 (as shown in Fig. 8B), the delivery member guard 2 is biased to its proximal position by the biasing member. Therefore, an indication can be provided to the user that the device is ready to be used. In a preferred example, the proximal portion of the delivery member guard comprises a color different to the tubular housing and the cap, and/or a mark for indication purposes. For example, the tubular housing may be white, and the cap may be red, in this example, the proximal portion of the delivery member guard can be yellow or green.

Optionally, in this example, the adapter 6 comprises an engaging member 61 and the housing comprises a counter engaging member 11 engaged with the engaging member 61 , as shown in Figs 1-2, such that the adapter 6 is rotationally immovable relative to the housing 1 when the delivery member guard 2 is in the distal position. Therefore, the user can only disengage the proximally directed surface 60a of the adapter 6 from the distally directed surface 51 a of the connector 5 by rotating the connector 5. In one example where the connector 5 is the tubular outer cap 30 of the medicament delivery device, the rotation of the connector from the first position to the second position is a part of the action causing the cap to be removed from the tubular housing 1 .

In a preferred example, the engaging member 61 of the adapter 6 and the counter engaging member 11 of the tubular housing 1 form at least one of a rib-and-rib engagement, a rib-and- recess engagement, and a rib-and-cut-out engagement.

In another example, instead of the connector, the adapter is configured to be manually rotated by the user relative to the connector around the longitudinal axis L of the tubular housing. Preferably, in this example, the connector 5' is covered by the tubular outer cap 30 of the medicament delivery device, as shown in Fig. 3 and Fig. 7 A, such that the user cannot access to the connector 5’ and therefore, the connector 5’ cannot be manually rotated by the user. In this example, the adapter 6’ comprises an engaging member 61 ’ and the cap 31 comprises a counter engaging member 312 engaged with the engaging member 61 ’ (as shown in Fig. 7B) such that the adapter 6’ is rotationally immovable relative to the cap 31 when the delivery member guard 2’ is in the distal position. Therefore, when the user rotates the cap 31 , the user rotates the adapter 6’ relative to the connector 5’ from the first position of the connector 5’ to the second position of the connector 5’. In one example, the engaging member 61 ’ of the adapter and the counter engaging member of the cap forme a rib-and-rib engagement, a rib-and-recess engagement, or a rib-and-cut-out engagement. Alternatively, the engaging member 61 ’ of the adapter 6’ comprises a non-circular cross-section perpendicular to the longitudinal axis L, and the counter engaging member 312 of the cap 31 comprises a counter non-circular cross-section perpendicular to the longitudinal axis L, as shown in Fig. 7B. In one example where the adapter 6’ comprises the ring-shaped body, the engaging member 61 ’ of the adapter 6’ is the inner circumferential surface 61 ’ of the ringshaped body of the adapter 6’.

Figs 7A-7E will also be used to explain another example where the connector 5’ is configured to be manually rotated by the user via the outer cap 30. This example will be explained later.

Furthermore, in one example, the sub-assembly comprises a delivery member cover assembly 3. The delivery member cover assembly 3 comprises the tubular outer cap 30 and a clutch member 32. The cap 31 is at least partially surrounded by the tubular outer cap 30. The clutch member 32 is rotationally fixed to the cap 31 and positioned longitudinally between the tubular outer cap 30 and the delivery member guard 2; 2’. The clutch member 32 comprises a clutch biasing member 320. The clutch member 32 is axially movable relative to the outer cap 30 from a relaxed position to a tensioned position when the delivery member guard 2; 2’ is moved from the distal position to the proximal position. The tubular outer cap 30 is axially fixed with and rotatable relative to the cap 31 . The tubular outer cap 30 comprises an engaging member 301 and the clutch member 32 comprises a counter engaging member 33. The engaging member 301 is adjacent to the counter engaging member 33 when the clutch biasing member 320 is in the related position.

In one example where the connector 5 is the tubular outer cap 30, the connector 5 is rotatable relative to the cap 31 when the clutch biasing member is in the tensioned position. As mentioned above, the connector 5 is axially immovable relative to the cap 31 by the distally directed surface 311 of the cap 31 and the proximally directed surface 501 of the connector 5. As there is no rotationally limiting structure between the connector 5 and the cap 31 , the connect 5 can freely rotate relative to the cap 31 . In one example, the connector 5 comprises a hook 302 positioned within an annular groove of the cap 31 . The hook 302 comprises the proximally directed surface 501 of the connector 5. The edge of the annular groove of the cap 31 comprises the distally directed surface 311 , as shown in Fig. 8A. When the user turns the tubular outer cap 30, meaning that the user is turning the connector 5 from the first position to the second position relative to the adapter 6, the delivery member guard 2 is released and is biased to the proximal position by the biasing member. When the delivery member guard 2 is in the proximal position, the clutch biasing member 320 is compressed from its relaxed position to the tensioned position. Therefore, the engaging member 301 of the tubular outer cap 30 is adjacent to the counter engaging member 33 of the clutch member 32. Thus, when the user further turns the tubular outer cap 30 relative to the tubular housing 1 around the longitudinal axis, the engaging member 301 and the counter engaging member 33 are engaged, and thus, the clutch member 32 and the tubular outer cap 30 are both rotated. As the clutch member 32 is rotationally fixed to the cap 31 , the rotation of the clutch member 32 causes the cap 31 to be rotated, and therefore, the cap 31 can be detached from the tubular housing 1 .

The engagement between cap 31 and the clutch member 32 can be a rib-and-rib engagement, a rib-and-recess engagement, or a rib-and-cut-out engagement. Alternatively, an engaging member 322a of the clutch member comprises a non-circular cross-section perpendicular to the longitudinal axis L. The counter engaging member 312 of the cap 31 is a counter non-circular cross-section perpendicular to the longitudinal axis L, as shown in Figs 12-13.

In one example, the engaging member 301 of the tubular outer cap 30 is a protrusion extending from an inner wall of the tubular outer cap 30 towards the longitudinal axis L. In a preferred example, as shown in Fig. 10, the engaging member 301 is a rack. In a preferred example, the engaging member 301 is a set of ratchet teeth.

In one example, the counter engaging member 33 of the clutch member 32 is a counter protrusion 33 extending radially outwardly relative to the longitudinal axis L from an outer surface of the cap 31 . In a preferred example, the counter engaging member 33 comprises a flexible arm 331 extending partially around the longitudinal axis L, as shown in Fig. 13. In this example, the user can get an audible and/or a tactile indication if the user turns the tubular outer cap 30 in the direction that cannot result in removal of the cap 31 .

Furthermore, in one example, the clutch member 32 comprises a proximal portion 321 and a distal portion 322. The clutch biasing member 320 is longitudinally positioned between the proximal portion 321 and the distal portion 322, as shown in Fig. 9. The proximal portion 321 is releasably engaged with a distally directed surface on the inner surface of the tubular outer cap 30. In this example, the counter engaging member 33 of the clutch member 32 is arranged on an outer surface of the distal portion 322.

In one example, the adapter 6’ is the distal portion 322 of the clutch member 32, as shown in Fig. 7A and Fig. 7D. In one example where the connector 5’ is an independent component from the tubular outer cap 30, the connector 5’ is positioned longitudinally between the tubular outer cap 30 and the delivery member guard 2’ and is positioned at least partially between the tubular outer cap 30 and the clutch member 32, as shown in Fig. 7A. In this example, the connector 5’ is rotatable relative to the clutch member 32. The connector 5’ comprises a rotational engaging member 52’ configured to engage with a counter rotational engaging member 301 of the tubular outer cap 30. Therefore, the connector 5’ is manually rotated from the first position to the second position via a rotation of the tubular outer cap 30 relative to the cap 31 .

In one example, the counter rotational engaging member 301 of the tubular outer cap 30 is the engaging member 301 of the tubular outer cap 30. In this example, when the clutch biasing member 320 is in the tensioned position, the counter engaging member 33 of the clutch member 32 is spaced apart from the engaging member 301 of the tubular outer cap 30, and the rotational engaging member 52’ of the connector 5’ is adjacent to the engaging member 301 of the tubular outer cap 30. Therefore, when the user rotates the tubular outer cap 30 relative to the tubular housing 1 around the longitudinal axis L, the connector 5’ is also rotated from its first position to the second position (as shown in Fig. 7D with the arrow R1). When the connector 5’ is in the second position, the adapter 6’, namely, the distal portion 322 of the clutch member 32 in this example, is moved in the proximal position relative to the tubular outer cap 30 by the biased delivery member guard 2’. Therefore, when the delivery member guard is in the proximal position, the counter engaging member 33 of the clutch member 32 is adjacent to the engaging member 301 of the tubular outer cap 30, as mentioned above. The user can remove the cap 31 by further rotating the tubular outer cap 30 (as shown in Fig. 7E with the arrow R2).

In one preferred example, the rotational engaging member 52’ of the connector 5’ is a protrusion. In a preferred example, the rotational engaging member 52’ and the counter rotational engaging member 301 form a ratchet engagement such that the connector is only rotationally fixed to the tubular outer cap in one rotational direction. Similar to the clutch member 32 mentioned above, the rotational engaging member 52’ of the connector 5' may comprise a flexible arm extending in the radial direction such that an audible and/or tactile indication is generated when the user rotates the tubular outer cap 30 in the direction that will not result in the removal of the cap 31 .

It should be noted that the clutch member 32 is configured to control the cap removal in a specific order, namely, the cap 31 should not be removed before the delivery member guard moves to the proximal position. This example is useful if the proximal movement of the delivery member guard and the cap removal are all linked to at least one specific function. For example, the proximal movement of the delivery member guard may be configured to trigger a mixing operation between multiple chambers of the medicament container, and the cap removal may be configured to cause a medicament delivery member to be mounted to the medicament container. In this example, if the medicament delivery member is mounted to the medicament container, the mixing operation may not work properly, as the increased pressure within the medicament container will cause the medicament to be expelled rather than enter into another chamber. However, if the cap removal and the proximal movement of the delivery member guard do not need to be carried out in a specific order, for example, the proximal movement of the delivery member guard is configured to be a tamper-evident that indicates the user that the sterilization of the medicament delivery member is changed (as the cap has been turned). In this example, there is not necessary to have the clutch member. The connector can be moved from the first position to the second position relative to the adapter during the cap removal.

Furthermore, the housing of the medicament delivery device, as mentioned in any example, may be provided with (i.e., molded in, molded with) a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties. Alternatively, a compound featuring persistently antimicrobial, antifungal, and/or antiviral properties may be applied to the molded (i.e., finished) components through secondary processes (e.g., chemical vapor deposition), spraying, or dipping processes. The inventive concept has mainly been described above with reference to 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.

Some aspects of the invention are defined by the following clauses.

1 . A sub-assembly of a medicament delivery device, the sub-assembly comprising: a tubular housing (1 ; 1 ’) extending along a longitudinal axis (L) between a proximal end and a distal end; a delivery member guard (2; 2’) comprising a proximal portion (20; 20’) arranged coaxially with the tubular housing (1); wherein the proximal portion (20; 20’) is configured to surround a medicament delivery member of the medicament delivery device; a biasing member operably attached to the housing (1 ; 1 ’) at one end and to the delivery member guard (2; 2’) at the other end; wherein the biasing member is configured to bias the delivery member guard (2; 2’) relative to the housing from a distal position to a proximal position; a cap (31) removably attached to the proximal end of the housing (1 ; 1 ’); wherein the cap (31) comprises a distally directed surface (311); a connector (5; 5’) comprising a proximally directed surface (501 ; 501 ’) operably engaged with the distally directed surface (311) of the cap (31) and comprising a distally directed surface (51 a; 51 a’); an adapter (6; 6’) operably connected to the delivery member guard (2; 2’) such that the adapter (6; 6’) is axially immovable relative to the delivery member guard (2; 2’) when the delivery member guard (2; 2) is in the distal position; wherein the adapter (6; 6’) comprises a proximally directed surface (60a; 60a’); and wherein the connector (5; 5’) is rotatable around the longitudinal axis (L) relative to the adapter (6; 6’) between a first position where the distally directed surface (51 a; 51 a’) of the connector (5; 5’) is engaged with the proximally directed surface (60a; 60a’) of the adapter (6; 6’) such that the proximal portion (20; 20’) of the delivery member guard (2; 2’) is blocked from being biased to the proximal position and a second position where the distally directed surface (51 a; 51 a’) of the connector (5; 5’) is offset relative to the proximally directed surface (60a; 60a’) of the adapter (6; 6’) such that the proximal portion (20; 20’) of the delivery member guard (2; 2’) can be biased to the proximal position by the biasing member. 2. The sub-assembly according to clause 1 , wherein the adapter comprises a ledge extending from a wall of the proximal portion of the delivery member guard; and wherein the ledge comprises the proximally directed surface of the adapter.

3. The sub-assembly according to clause 1 , wherein the adapter comprises a ringshaped body; wherein the adapter comprises a ledge extending from an inner surface of the ring-shaped body; wherein the ring-shaped body comprises a distally directed surface; and wherein the proximal portion of the delivery member guard comprises a proximally directed surface engaged with the distally directed surface of the ring-shaped body.

4. The sub-assembly according to clause 3, wherein the adapter comprises an engaging member (61) and the housing comprises a counter engaging member (11) engaged with the engaging member such that the adapter is rotationally immovable relative to the housing when the delivery member guard is in the distal position.

5. The sub-assembly according to clause 4, wherein the engaging member and the counter engaging member form at least one of a rib-and-rib engagement, a rib-and- recess engagement, and a rib-and-cut-out engagement.

6. The sub-assembly according to clause 3, wherein the adapter comprises an engaging member and the cap comprises a counter engaging member engaged with the engaging member such that the adapter is rotationally immovable relative to the cap when the delivery member guard is in the distal position.

7. The sub-assembly according to clause 6, wherein the engaging member comprises a non-circular cross-section perpendicular to the longitudinal axis, and the counter engaging member comprises a counter non-circular cross-section perpendicular to the longitudinal axis.

8. The sub-assembly according to clause 7, wherein the engaging member of the adapter is an inner circumferential surface of the ring-shaped body of the adapter.

9. The sub-assembly according to any of the preceding clauses, wherein the connector comprises a body; wherein the connector comprises a ledge extending from an inner surface of the body of the connector towards the longitudinal axis; and wherein the ledge comprises the distally directed surface of the connector.

10. The sub-assembly according clause 9 when dependent on clause 3, wherein the body of the connector is the ring-shaped body. 11 . The sub-assembly according to any of the preceding clauses, comprising a delivery member cover assembly; wherein the delivery member cover assembly comprises: a tubular outer cap and a clutch member; wherein the cap is at least partially surrounded by the tubular outer cap; wherein the clutch member is rotationally fixed to the cap and positioned longitudinally between the tubular outer cap and the delivery member guard; wherein the clutch member comprises a clutch biasing member, the clutch member being axially movable relative to the outer cap from a relaxed position to a tensioned position when the delivery member guard is moved from the distal position to the proximal position; wherein the tubular outer cap is axially fixed with and rotatable relative to the cap; wherein the tubular outer cap comprises an engaging member and the clutch member comprises a counter engaging member; and wherein the plurality of engaging members is adjacent to the plurality of counter engaging members when the clutch biasing member is in the tensioned position.

12. The sub-assembly according to clause 11 , wherein the connector is the tubular outer cap.

13. The sub-assembly according to clause 11 , wherein the connector is positioned longitudinally between the tubular outer cap and the delivery member guard and is positioned at least partially between the tubular outer cap and the clutch member; wherein the connector is rotatable relative to the clutch member; wherein the connector comprises a rotational engaging member; wherein the outer cap comprises a counter rotational engaging member engaged with the rotational engaging member such that the connector is manually rotated from the first position to the second position via a rotation of the tubular outer cap relative to the cap.

14. The sub-assembly according to clauses 11-13, wherein the engaging member of the tubular outer cap is the counter rotational engaging member.

15. The sub-assembly according to clauses 14, wherein the rotational engaging member of the connector is a counter protrusion; and wherein the rotational engaging member and the counter rotational engaging member form a ratchet engagement such that the connector is only rotationally fixed to the tubular outer cap in one rotational direction. 16. The sub-assembly according to any of clauses 11-15, wherein the clutch member comprises a proximal portion and a distal portion; wherein the clutch biasing member is longitudinally positioned between the proximal portion and the distal portion; wherein the proximal portion is releasably engaged with a distally directed surface on the inner surface of the tubular outer cap; and wherein the adapter is the distal portion of the clutch member.

17. The sub-assembly according to any of clauses 11-16, wherein the counter engaging member of the clutch member is a plurality of counter protrusions; wherein the counter protrusion extends radially outwardly relative to the longitudinal axis from an outer surface of the cap.

18. The sub-assembly according to clause 17, wherein the counter engaging member of the clutch member is arranged on an outer surface of the distal portion.

19. The sub-assembly according to clause 11-18, wherein the plurality of counter engaging members comprises a flexible arm extending partially around the longitudinal axis.

20. The sub-assembly according to any of the preceding clauses, wherein the delivery member guard is partially arranged within the housing; wherein the tubular proximal portion of the delivery member guard is arranged telescopically relative to the proximal end of the housing.

21. The sub-assembly according to any of the preceding clauses, wherein the housing comprises a proximally directed surface; wherein the delivery member guard comprises a distally directed surface; and wherein the biasing member is a spring extending between a first end engaged with the proximally directed surface of the housing and a second end engaged with the distally directed surface of the delivery member guard.

Claims

CLAIM

1 . A sub-assembly of a medicament delivery device, the sub-assembly comprising: a tubular housing (1 ; 1 ’) extending along a longitudinal axis (L) between a proximal end and a distal end; a delivery member guard (2; 2’) comprising a proximal portion (20; 20’) arranged coaxially with the tubular housing (1); wherein the proximal portion (20; 20’) is configured to surround a medicament delivery member of the medicament delivery device; a biasing member operably attached to the housing (1 ; 1 ’) at one end and to the delivery member guard (2; 2’) at the other end; wherein the biasing member is configured to bias the delivery member guard (2; 2’) relative to the housing from a distal position to a proximal position; a cap (31) removably attached to the proximal end of the housing (1 ; 1 ’); wherein the cap (31) comprises a distally directed surface (311); a connector (5; 5’) comprising a proximally directed surface (501 ; 501 ’) operably engaged with the distally directed surface (311) of the cap (31) and comprising a distally directed surface (51 a; 51 a’); an adapter (6; 6’) operably connected to the delivery member guard (2; 2’) such that the adapter (6; 6’) is axially immovable relative to the delivery member guard (2; 2’) when the delivery member guard (2; 2) is in the distal position; wherein the adapter (6; 6’) comprises a proximally directed surface (60a; 60a’); and wherein the connector (5; 5’) is rotatable around the longitudinal axis (L) relative to the adapter (6; 6’) between a first position where the distally directed surface (51 a; 51 a’) of the connector (5; 5’) is engaged with the proximally directed surface (60a; 60a’) of the adapter (6; 6’) such that the proximal portion (20; 20’) of the delivery member guard (2; 2’) is blocked from being biased to the proximal position and a second position where the distally directed surface (51a; 51 a’) of the connector (5; 5’) is offset relative to the proximally directed surface (60a; 60a’) of the adapter (6;

6’) such that the proximal portion (20; 20’) of the delivery member guard (2; 2’) can be biased to the proximal position by the biasing member.

2. The sub-assembly according to claim 1 , wherein the adapter comprises a ledge extending from a wall of the proximal portion of the delivery member guard; and wherein the ledge comprises the proximally directed surface of the adapter.

3. The sub-assembly according to claim 1 , wherein the adapter comprises a ringshaped body; wherein the adapter comprises a ledge extending from an inner surface of the ring-shaped body; wherein the ring-shaped body comprises a distally directed surface; and wherein the proximal portion of the delivery member guard comprises a proximally directed surface engaged with the distally directed surface of the ring-shaped body.

4. The sub-assembly according to claim 3, wherein the adapter comprises an engaging member (61) and the housing comprises a counter engaging member (11) engaged with the engaging member such that the adapter is rotationally immovable relative to the housing when the delivery member guard is in the distal position.

5. The sub-assembly according to claim 4, wherein the engaging member and the counter engaging member form at least one of a rib-and- rib engagement, a rib-and- recess engagement, and a rib-and-cut-out engagement.

6. The sub-assembly according to claim 3, wherein the adapter comprises an engaging member and the cap comprises a counter engaging member engaged with the engaging member such that the adapter is rotationally immovable relative to the cap when the delivery member guard is in the distal position.

7. The sub-assembly according to claim 6, wherein the engaging member comprises a non-circular cross-section perpendicular to the longitudinal axis, and the counter engaging member comprises a counter non-circular cross-section perpendicular to the longitudinal axis.

8. The sub-assembly according to claim 7, wherein the engaging member of the adapter is an inner circumferential surface of the ring-shaped body of the adapter.

9. The sub-assembly according to any of the preceding claims, wherein the connector comprises a body; wherein the connector comprises a ledge extending from an inner surface of the body of the connector towards the longitudinal axis; and wherein the ledge comprises the distally directed surface of the connector.

10. The sub-assembly according claim 9 when dependent on claim 3, wherein the body of the connector is the ring-shaped body.

11 . The sub-assembly according to any of the preceding claims, comprising a delivery member cover assembly; wherein the delivery member cover assembly comprises: a tubular outer cap and a clutch member; wherein the cap is at least partially surrounded by the tubular outer cap; wherein the clutch member is rotationally fixed to the cap and positioned longitudinally between the tubular outer cap and the delivery member guard; wherein the clutch member comprises a clutch biasing member, the clutch member being axially movable relative to the outer cap from a relaxed position to a tensioned position when the delivery member guard is moved from the distal position to the proximal position; wherein the tubular outer cap is axially fixed with and rotatable relative to the cap; wherein the tubular outer cap comprises an engaging member and the clutch member comprises a counter engaging member; and wherein the plurality of engaging members is adjacent to the plurality of counter engaging members when the clutch biasing member is in the tensioned position. The sub-assembly according to claim 11 , wherein the connector is the tubular outer cap. The sub-assembly according to claims 11 or 12, wherein the engaging member of the tubular outer cap is the counter rotational engaging member. The sub-assembly according to any of the preceding claims, wherein the delivery member guard is partially arranged within the housing; wherein the tubular proximal portion of the delivery member guard is arranged telescopically relative to the proximal end of the housing. The sub-assembly according to any of the preceding claims, wherein the housing comprises a proximally directed surface; wherein the delivery member guard comprises a distally directed surface; and wherein the biasing member is a spring extending between a first end engaged with the proximally directed surface of the housing and a second end engaged with the distally directed surface of the delivery member guard.