Autoinjector needle-housing assembly

Abstract

AUTOINJECTOR NEEDLE-HOUSING ASSEMBLY The present disclosure concerns an autoinjector needle-housing assembly (110) extending along an axis in a longitudinal direction from a proximal end to a distal end. The autoinjector needle-housing assembly (110) includes a housing (120) and a needle (140) positioned at least partially within the housing (120). The autoinjector needle-housing assembly (110) further includes a sterility barrier (150) attached to the housing (120), the housing (120) and the sterility barrier (150) forming a first sealed cavity (155) and a distal end of the needle (140) being in the first sealed cavity (155) when in a first position. The autoinjector needle-housing assembly (110) further includes a recess (182) provided by the distal end of the autoinjector needle-housing assembly (110), the recess (182) being shaped to receive a cartridge (170) such that when the cartridge (170) is positioned in the recess (182) the recess (182) and the cartridge (170) form a second sealed cavity (180) between the autoinjector needle-housing assembly (110) and the cartridge (170), the distal end of the needle (140) traversing the second sealed cavity (180) when moving from the first position to a second position at which the distal end of the needle (140) is inside the cartridge (170). The autoinjector needle-housing assembly (110) further includes a seal (157) positioned on a distal end surface of the housing (120) such that the seal (157) is configured to be compressed in an axial direction relative to the axis (112) when the cartridge (170) is positioned in the recess (182) to seal the second sealed cavity (180). Corresponding methods are also described. [Fig. 2]

Description

AUTOINJECTOR NEEDLE-HOUSING ASSEMBLYTECHNICAL FIELD

[0001] The present disclosure concerns needle-housing assemblies, and particularly autoinjector needle-housing assemblies comprising a sterile cavity.BACKGROUND

[0002] Different types of injection needle assemblies have been developed during a number of years, where the aim is to have a more or less complete assembly that is attached to a medicament container. Regarding the aspect of attachment of injection needles to medicament containers, there is often a requirement that the rear end of the injection needle should protrude into the interior of the container. This could be a drawback if the medicament reacts with the material of the needle when exposed for a period of time. In that respect it would be desirable to have the rear part of the needle outside the container until the injection is to be performed. On the other hand, this then requires that the rear end of the needle could be moved fairly easily into the container and also that the rear end of the needle is kept in a sterile environment until it is moved into the container. Whilst the injection needle assembly described in WO2014 / 076225 can provide a sterile environment around the needle, the applicant has appreciated that further improvements can be made to this design to improve the sterile environment.SUMMARY

[0003] The present disclosure is defined by the appended claims, to which reference should now be made.

[0004] 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.

[0005] Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component.

[0006] Similarly, the terms “radial”, “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction, and “circumferential” is the direction around a longitudinal axis of the device and / or component.

[0007] 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. The terms “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.

[0008] A first aspect of the present disclosure concerns an autoinjector needle-housing assembly extending along an axis in a longitudinal direction from a proximal end to a distal end, the autoinjector needle-housing assembly comprising a housing, a needle positioned at least partially within the housing, a sterility barrier attached to the housing, the housing and the sterility barrier forming a first sealed cavity and a distal end of the needle being in the first sealed cavity when in a first position, a recess provided by the distal end of the autoinjector needle-housing assembly, the recess being shaped to receive a cartridge such that when the cartridge is positioned in the recess the recess and the cartridge form a second sealed cavity between the autoinjector needle-housing assembly and the cartridge, the distal end of the needle traversing the second sealed cavity when moving from the first position to a second position at which the distal end of the needle is inside the cartridge, and a seal positioned on a distal end surface of the housing such that the seal is configured to be compressed in an axial direction relative to the axis when the cartridge is positioned in the recess to seal the second sealed cavity. The sterility barrier can be a separate component from the housing or an integral part of the housing. Preferably, the distal end of the needle is spaced apart from the sterility barrier.

[0009] This autoinjector needle-housing assembly can provide a complete sterile environment, not just for the needle but also for the part of the cartridge that the needle pierces. This can reduce the chance of contaminants.

[0010] Preferably, the recess is formed between the sterility barrier of the autoinjector needle-housing assembly and the cartridge.

[0011] Preferably, the sterility barrier comprises a wall positioned between the proximal part of the housing and the distal part of the housing, and the wall extends in a radial direction relative to the axis.

[0012] Preferably, the seal comprises a deformable material. In one particular example, the deformable material comprises a thermoplastic elastomer (TPE).

[0013] Preferably, the seal is permanently coupled to the distal end surface of the housing.

[0014] Preferably, the seal comprises a first material and the distal part of the housing comprises a second material that is different than the first material, and wherein the first material is more compressible than the second material.

[0015] Preferably, the seal is configured to contact a shoulder of the cartridge when the cartridge is positioned in the recess. Preferably, the seal is a ring.

[0016] Preferably, the distal part of the housing comprises a tubular section and the proximal part of the housing comprises a wall extending in a radial direction relative to the axis, the wall extending across the proximal end of the tubular section. In one particular example, the first sealed cavity is tubular, and is formed by the tubular section of the housing, the wall of the housing and the wall of the sterility barrier.

[0017] Preferably, the distal part of the housing includes a pair of arms extending in the distal direction from the distal end surface the housing.

[0018] Preferably, each of the pair of arms include a protrusion extending radially outwards at a distal end of each of the pair of arms.

[0019] Preferably, each of the pair of arms include a protrusion extending radially inwards.

[0020] A second aspect of the present disclosure concerns an autoinjector sub-assembly comprising the autoinjector needle-housing assembly of any previous claim and a needle cap (preferably a rigid needle shield) attached to the autoinjector needle-housing assembly. Preferably, the needle cap and the autoinjector needle-housing assembly (preferably the wall of the housing of the autoinjector needle-housing assembly) define a third sealed cavity. Preferably, a proximal end of the needle is in the third sealed cavity.

[0021] A third aspect of the present disclosure concerns a method of assembly of an autoinjector or an autoinjector sub-assembly, the method comprising the steps of: providing an autoinjector needle-housing assembly extending along an axis in a longitudinal direction from a proximal end to a distal end, the autoinjector needle-housing assembly comprising a housing, a needle positioned at least partially within the housing, a sterility barrier attached to thehousing, the housing and the sterility barrier forming a first sealed cavity and a distal end of the needle being in the first sealed cavity when in a first position, a recess provided by the distal end of the autoinjector needle-housing assembly, the recess being shaped to receive a cartridge such that when the cartridge is positioned in the recess the recess and the cartridge form a second sealed cavity between the autoinjector needle-housing assembly and the cartridge, the distal end of the needle traversing the second sealed cavity when moving from the first position to a second position at which the distal end of the needle is inside the cartridge, and a seal positioned on a distal end surface of the housing such that the seal is configured to be compressed in an axial direction relative to the axis when the cartridge is positioned in the recess to seal the second sealed cavity; and inserting the cartridge into the recess to create a second sealed cavity formed between the cartridge and the sterility barrier. Preferably, the step of inserting a cartridge into the recess is carried out in a sterile environment. This method can provide a complete sterile environment, not just for the needle but also for the part of the cartridge that the needle pierces. This can reduce the chance of contaminants.

[0022] Generally, 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, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Embodiments of the present disclosure will now be described by way of example only and with reference to the accompanying drawings, in which:

[0024] Figure 1 shows exploded perspective view of a medicament delivery device.

[0025] Figure 2 shows a cross-sectional view of an autoinjector sub-assembly of the medicament delivery device shown in Figure 1.

[0026] Figure 3 shows an exploded perspective view of the cartridge of the autoinjector sub-assembly of Figure 2.

[0027] Figure 4 shows a perspective view of the needle housing assembly shown in Figure 2.

[0028] Figure 5 shows a cross-sectional view of an autoinjector sub-assembly including a needle housing assembly as shown in Figure 4 prior to final assembly.

[0029] Figure 6 shows a cross-sectional view of an autoinjector sub-assembly including a needle housing assembly as shown in Figure 4 at final assembly.

[0030] Figure 7 shows a cross-sectional view of an autoinjector sub-assembly including a needle housing assembly as shown in Figure 4.

[0031] Figure 8 shows a cross-sectional view of an autoinjector sub-assembly including a needle housing assembly as shown in Figure 4 during needle septum penetration.DETAILED DESCRIPTION

[0032] Figure 1 illustrates an exploded view of a medicament delivery device 100. As shown in Figure 1, the medicament delivery device 100 includes a generally tubular outer housing 102, a cartridge 170, a needle housing assembly 110, a front collar 105, and a cap 104. Upon final assembly, cartridge 170, needle housing assembly 110, and front collar 105 are positioned at least partially within the generally tubular outer housing 102, and the cap 104 is removably positioned over the needle 140 of the needle housing assembly 110. With reference to Figures 2-8, the needle housing assembly 110 will now be described in additional detail.

[0033] As shown in Figure 2, the needle housing assembly 110 includes a housing 120. In one example, as shown in Figure 4, the housing 120 includes a proximal part 125 and a distal part 130. The needle housing assembly 110 further includes a needle 140 positioned at least partially within the housing 120. In one example, the needle 140 is attached to a needle carrier 141 configured to move within a threaded channel 111 of the needle housing assembly 110. The needle housing assembly 110 further includes a sterility barrier 150 attached to the housing 120. As shown in the cross-sectional views in Figures 9-12, the housing 120 and the sterility barrier 150 form a first sealed cavity 155. A distal end of the needle 140 is in the first sealed cavity 155 when in a first position.

[0034] The autoinjector needle-housing assembly 110 further comprises a recess 182 provided by the distal end of the autoinjector needle-housing assembly 110. The recess 182 is shaped to receive a cartridge 170 such that when the cartridge 170 is positioned in the recess 182 the recess 182 and the cartridge 170 form a second sealed cavity 180 between the autoinjector needle-housing assembly 110 and the cartridge 170, the distal end of the needle 140 traversing the second sealed cavity 180 when moving from the first position to a second position at which the distal end of the needle 140 is inside the cartridge 170. The autoinjector needle-housing assembly 110 further comprises a seal 157 positioned on a distal end surface of the housing 120 such that the seal 157 is configured to be compressed in an axial direction relative to the axis 112 when the cartridge 170 is positioned in the recess 182 to seal the second sealed cavity 180. In one particular example, as shown in Figures 5-8, the seal 157 is configured to contact a shoulder 174 of the cartridge 170 when the cartridge 170 is positioned in the recess182. The seal 157 can be part of the sterility barrier 150, part of the cartridge 170, part of the housing 120, or an independent component, e.g. a ring such as a ring of a solid material.

[0035] In use, the seal 157 thereby forms the second sealed cavity 180 to thereby provide a closed volume in which the needle 140 can penetrate the septum 178 with a reduced risk of contamination. In addition, the contact of the seal 157 with the cartridge 170 prevents rattling of components during transport of the autoinjector needle-housing assembly 110. Further, the deformable nature of the seal 157 allows for broader manufacturing tolerances for the components of the autoinjector needle-housing assembly 110.

[0036] In one example, the recess 182 is formed between the sterility barrier 150 of the autoinjector needle-housing assembly 110 and the distal end of the autoinjector needle-housing assembly 110. The sterility barrier 150 may include a wall 154 positioned between the proximal part 125 of the housing 120 and the distal part 130 of the housing 120. Such a wall 154 may extend in a radial direction relative to the axis 112.

[0037] In one example, the seal 157 comprises a deformable material. In one particular example, the deformable material comprises a thermoplastic elastomer (TPE).

[0038] In one example, the sterility barrier 150 and the housing 120 are separate components. In an alternative embodiment, the sterility barrier 150 and the housing 120 are a single integral part, with the sterility barrier 150 therefore fixed relative to the housing 120 and the needle 140 being moveable relative to the housing 120 instead.

[0039] The proximal end of the needle 140 and the distal end of the needle 140 may both have angled ends for ease of penetration of the injection site and the cartridge septum respectively; these features are optional. Typically, the distal end of the needle 140 is spaced apart from the sterility barrier 150 (specifically from the wall 154 of the sterility barrier 150). As a result, the needle 140 is also spaced apart from the cartridge 170 when the needle housing assembly 110 is provided in an autoinjector. Typically, the proximal end of the needle 140 is spaced apart from a needle shield (not shown) when the needle housing assembly 110 is provided in an autoinjector.

[0040] In one example, the seal 157 is permanently coupled to the distal end surface of the housing 120. In one such example, the seal 157 is formed as an integral component of the housing 120. In another example, the seal 157 is removably coupled to the distal end surface of the housing 120.

[0041] In one example, the seal 157 comprises a first material and the distal part 130 of the housing 120 comprises a second material that is different than the first material, where the first material is more compressible than the second material.

[0042] As shown in Figure 3, the cartridge 170 may include a cartridge head 172, a cartridge neck 173, a cartridge shoulder 174 and a cartridge body 175, along with a cartridge crimp 177 and a cartridge septum 178. The cartridge 170 would typically also include a stopper in a distal portion of the cartridge (not shown). The cartridge septum 178 is held in place across a hole in the cartridge by the cartridge crimp 177. The cartridge is filled with a fluid such as a liquid medicament. As described further below, the proximal end of the cartridge 170 forms the second sealed cavity 180 along with the sterility barrier 150. As discussed above, the seal 157 can help create an airtight seal between the sterility barrier 150 and the cartridge 170. In particular, the cartridge 170 is configured to contact the seal 157 when the cartridge 170 is positioned in the recess 182 to thereby form the second sealed cavity 180 between the autoinjector needle-housing assembly 110 and the cartridge 170. Typically, only a proximal end of the cartridge 170, in this example the head 172 of the cartridge 170, is inside the recess 182.

[0043] The cartridge 170 shown in the Figures has a cartridge exit hole at the proximal end of the cartridge 170, along with a particular cartridge shape and a particular septum and crimp design to seal the cartridge exit hole, with an optional hole in the crimp to allow the needle direct access to the septum. The shape and design of the cartridge 170 (including the shape and design of the head, neck, shoulder and body of the cartridge) can be varied, as can the method of closure of the cartridge (a crimp and septum design in this case), and a particular cartridge style, closure, shape or design is not essential to the present disclosure described herein. Typically, the specific design of a needle housing assembly (particularly the distal part 130 of the housing 120, the sterility barrier 150 and / or the needle 140) would be adjusted according to the particular properties of the proposed cartridge.

[0044] In one example, the distal part 130 of the housing 120 comprises a tubular section 132 and the proximal part 125 of the housing comprises a wall 126 extending in a radial direction relative to the axis 112, the wall 126 extending across the proximal end of the tubular section 132. In one such example, the first sealed cavity 155 is tubular, and is formed by the tubular section of the housing 120, the wall 126 of the housing 120, and the wall 154 of the sterility barrier 150.

[0045] In one example, as shown in Figure 4, the distal part 130 of the housing 120 includes a pair of arms 134 extending in the distal direction from the distal end surface of the housing 120. In one such example, each of the pair of arms 134 include a protrusion 135 extending radially outwards at a distal end of each of the pair of arms 134 to engage with a corresponding optional cut-outs 184 in the cartridge holder. Additionally or alternatively, eachof the pair of arms 134 may include a protrusion 136 extending radially inwards to engage with a corresponding optional cut-outs 179 in the cartridge 170.

[0046] Figure 5 shows a cross-sectional view of the autoinjector sub-assembly including the needle housing assembly 110 prior to final assembly. In particular, a gap 176 is shown between the cartridge holder 190 and the housing 120, and the seal 157 is shown in a non-compressed state. Figure 6 shows a cross-sectional view of the autoinjector sub-assembly including the needle housing assembly 110 at final assembly. In particular, the cartridge holder 190 is shown snap fit to the housing 120 such that the gap 176 is eliminated, and the seal 157 is shown in a compressed state.

[0047] Figure 7 shows a cross-sectional view of an autoinjector sub-assembly including the needle housing assembly 110, illustrating the second sealed cavity 180 between the autoinjector needle-housing assembly 110 and the cartridge 170. As shown in Figure 7, the seal 157 contacting the shoulder 174 of the cartridge 170 creates a complete sterile environment in the second sealed cavity 180, not just for the needle 140 but also for the septum 178 that the needle 140 pierces. Such a sterile environment can reduce the chance of contaminants accidentally entering the liquid medicament in the cartridge 170 during penetration of the septum 178 by the needle 140. Figure 8 shows a cross-sectional view of an autoinjector subassembly including the needle housing assembly 110 during penetration of the septum 178 by the needle 140.

[0048] The structure described above results in three sealed cavities, namely a first sealed cavity 155, a second sealed cavity 180, and a third sealed cavity 146. The third sealed cavity 146 is formed by the needle cap 103 and the needle carrier 141, as shown in Figure 2. A proximal end of the needle 140 is positioned the third sealed cavity 146. The first sealed cavity 155 is formed by the housing 120 (specifically by the tubular section 132 and the wall 126 in this example) and the sterility barrier 150 (specifically by the wall 154 in this example). The second sealed cavity 180 is formed by the sterility barrier 150 (specifically the tubular body 152 and the wall 154 in this example), the seal 157, and the cartridge 170 (specifically the cartridge crimp 177 and the cartridge septum 178 in this example).

[0049] During assembly, the needle housing assembly 110 would typically be assembled (preferably in a sterile environment to provide a sterile environment in the first sealed cavity 155), followed by the addition of the needle cap 103 (again preferably in a sterile environment to provide a sterile environment in the third sealed cavity 146). This would then be followed by the insertion of the cartridge 170 into the needle housing assembly 110 (again preferably in a sterile environment to provide a sterile environment in the second sealed cavity180). Before or after insertion of the cartridge 170 into the needle housing assembly 110, the cartridge 170 is inserted into the generally tubular outer housing 102. The entire assembly process can take place in the same location, but sub-assemblies could also be assembled in one location and then transported to another location for further assembly. During insertion of the cartridge 170 into the needle housing assembly 110, the sterility barrier 150 remains in place relative to the housing 120 (i.e. it does not move relative to the housing 120).

[0050] To use an autoinjector comprising the assemblies described herein, the needle cap 103 is first removed (typically at the same time as a corresponding cap 104). The cartridge 170 is then pushed in the proximal direction by a mechanism within the autoinjector (or directly by the action of a user). The needle carrier 141, which is fixedly attached to the needle 140, moves in a distal direction along axis 112 within the threaded channel 111 of the needle housing assembly 110 until the septum 178 of the cartridge 170 are pierced by the distal end of the needle 140 (as shown in Figure 8). This allows injection of the substance in the cartridge 170 to commence (typically driven by a powerpack within the autoinjector).

[0051] The examples given herein primarily relate to autoinjectors. However, other medicament delivery devices such as pen injectors could also include the designs described herein.

[0052] The examples given herein include a needle. Whilst this design is primarily for needle-based injection devices, other medicament delivery members, such as a jet injector, could alternatively be used in the designs described herein, for example by replacing the needle or the front portion of the needle (the part in the needle shield cavity) with a jet injector.

[0053] The examples described herein would typically be implemented in autoinjectors. In addition to the parts described herein, for example those in the autoinjector sub-assembly, an autoinjector would generally comprise an outer housing, a cap, a needle guard, and a powerpack for pushing a stopper of the cartridge towards the proximal end of the autoinjector to expel the medicament from the cartridge. Typically, an autoinjector is tubular in shape.

[0054] An autoinjector comprising assemblies as described herein typically comprises an outer housing, a cap, a needle guard, the cartridge holder (which may be part of the outer housing), the needle shield (for example a rigid needle shield and / or a flexible needle shield), the needle, the cartridge, a medicament in the cartridge, and a powerpack.

[0055] Another aspect of the present disclosure concerns a method of assembly of an autoinjector or an autoinjector sub-assembly, the method comprising the steps of: providing an autoinjector needle-housing assembly extending along an axis in a longitudinal direction froma proximal end to a distal end, the autoinjector needle-housing assembly comprising a housing, a needle positioned at least partially within the housing, a sterility barrier attached to the housing, the housing and the sterility barrier forming a first sealed cavity and a distal end of the needle being in the first sealed cavity when in a first position, a recess provided by the distal end of the autoinjector needle-housing assembly, the recess being shaped to receive a cartridge such that when the cartridge is positioned in the recess the recess and the cartridge form a second sealed cavity between the autoinjector needle-housing assembly and the cartridge, the distal end of the needle traversing the second sealed cavity when moving from the first position to a second position at which the distal end of the needle is inside the cartridge, and a seal positioned on a distal end surface of the housing such that the seal is configured to be compressed in an axial direction relative to the axis when the cartridge is positioned in the recess to seal the second sealed cavity; and inserting the cartridge into the recess to create a second sealed cavity formed between the cartridge and the sterility barrier. Preferably, the step of inserting a cartridge into the recess is carried out in a sterile environment. This method can provide a complete sterile environment, not just for the needle but also for the part of the cartridge that the needle pierces. This can reduce the chance of contaminants.

[0056] Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the present disclosure which is defined by the following claims.

[0057] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0058] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hi dradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivityreactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

[0059] Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

[0060] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0061] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide- 1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene- related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1)inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD 19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation wl37 (CDwl37) agonists, cluster of differentiation 158 (CD 158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD 159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation wl23 (CDwl23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CT A) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0062] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta- la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol,satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0063] Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

[0064] Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0065] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5 -fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine. Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r- TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline,Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0066] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal -derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0067] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IV AC, HyperCVAD, R- HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HID AC, 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, OF AR, 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.

Claims

CLAIMS1. An autoinjector needle-housing assembly (110) extending along an axis (112) in a longitudinal direction from a proximal end to a distal end, the autoinjector needle-housing assembly (110) comprising: a housing (120); a needle (140) positioned at least partially within the housing (120); a sterility barrier (150) attached to the housing (120), the housing (120) and the sterility barrier (150) forming a first sealed cavity (155) and a distal end of the needle (140) being in the first sealed cavity (155) when in a first position; a recess (182) provided by the distal end of the autoinjector needle-housing assembly (110), the recess (182) being shaped to receive a cartridge (170) such that when the cartridge (170) is positioned in the recess (182) the recess (182) and the cartridge (170) form a second sealed cavity (180) between the autoinjector needle-housing assembly (110) and the cartridge (170), the distal end of the needle (140) traversing the second sealed cavity (180) when moving from the first position to a second position at which the distal end of the needle (140) is inside the cartridge (170); and a seal (157) positioned on a distal end surface of the housing (120) such that the seal (157) is configured to be compressed in an axial direction relative to the axis (112) when the cartridge (170) is positioned in the recess (182) to seal the second sealed cavity (180).

2. The autoinjector needle-housing assembly (110) of claim 1, wherein the recess (182) is formed between the sterility barrier (150) of the autoinjector needle-housing assembly (110) and the cartridge (170).

3. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the sterility barrier (150) comprises a wall (154) positioned between the proximal part (125) of the housing (120) and the distal part (130) of the housing (120), and wherein the wall (154) extends in a radial direction relative to the axis (112).

4. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the seal (157) comprises a deformable material, preferably wherein the deformable material comprises a thermoplastic elastomer (TPE).

5. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the seal (157) is permanently coupled to the distal end surface of the housing (120).

6. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the seal (157) comprises a first material and the distal part (130) of the housing (120) comprises a second material that is different than the first material, and wherein the first material is more compressible than the second material.

7. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the seal (157) is configured to contact a shoulder (174) of the cartridge (170) when the cartridge (170) is positioned in the recess (182).

8. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the seal (157) is a ring.

9. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the distal part (130) of the housing (120) comprises a tubular section (132) and the proximal part (125) of the housing (120) comprises a wall (126) extending in a radial direction relative to the axis (112), the wall (126) extending across a proximal end of the tubular section (132), preferably wherein the first sealed cavity (155) is tubular and is formed by the tubular section (132) of the housing (120), the wall (126) of the housing (120), and the wall (154) of the sterility barrier (150).

10. The autoinjector needle-housing assembly (110) of any of the preceding claims, wherein the distal part (130) of the housing (120) includes a pair of arms (134) extending in a distal direction from the distal end surface of the housing (120), preferably wherein each of the pair of arms (134) include a protrusion (135) extending radially outwards at a distal end of each of the pair of arms (134).

11. The autoinjector needle-housing assembly (110) claim 10, wherein each of the pair of arms (134) includes a protrusion (136) extending radially inwards.

12. An autoinjector sub-assembly comprising the autoinjector needle-housing assembly (110) of any of the preceding claims and a needle shield attached to the autoinjector needle-housing assembly (110).

13. The autoinjector sub-assembly of claim 1, comprising a needle cap (103) and the needle carrier (141) defining a third sealed cavity (146), wherein a proximal end of the needle (140) is in the third sealed cavity (146).

14. A method of assembling an autoinjector sub-assembly (110), the method comprising the steps of: providing an autoinjector needle-housing assembly (110) extending along an axis (112) in a longitudinal direction from a proximal end to a distal end, the autoinjector needlehousing assembly (110) comprising a housing (120), a needle (140) positioned at least partially within the housing (120), a sterility barrier (150) attached to the housing (120), the housing (120) and the sterility barrier (150) forming a first sealed cavity (155) and a distal end of the needle (140) being in the first sealed cavity (155) when in a first position, a recess (182) provided by the distal end of the autoinjector needle-housing assembly (110), the recess (182) being shaped to receive a cartridge (170) such that when the cartridge (170) is positioned in the recess (182) the recess (182) and the cartridge (170) form a second sealed cavity (180) between the autoinjector needle-housing assembly (110) and the cartridge (170), the distal end of the needle (140) traversing the second sealed cavity (180) when moving from the first position to a second position at which the distal end of the needle (140) is inside the cartridge (170), and a seal (157) positioned on a distal end surface of the housing (120) such that the seal (157) is configured to be compressed in an axial direction relative to the axis (112) when the cartridge (170) is positioned in the recess (182) to seal the second sealed cavity (180); and inserting the cartridge (170) into the recess (182) to create a second sealed cavity (180) formed between the cartridge (170) and the sterility barrier (150).

15. The method of claim 14, wherein the step of inserting a cartridge (170) into the recess (182) is carried out in a sterile environment.

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