Drive assembly for a medicament delivery device

Abstract

A drive assembly for a medicament delivery device, comprising: a nut (17) having a central through-opening (17b), a plunger rod (19) received in the through-opening (17b), a torsion member configured to cause rotation of one of the nut (17) and the plunger rod (19) relative to the other one of the nut (17) and the plunger rod (19) when the torsion member releases its stored energy, wherein one of the nut (17) and the plunger rod (19) has a cam surface (17c) and the other one of the nut (17) and the plunger rod (19) has a follower (19b) configured to cooperate with the cam surface (17c), wherein the plunger rod (19) has a first thread (19a) and the nut (17) has a second thread (17d) configured to cooperate with the first thread (19a), wherein the cam surface (17c) and the follower (19b) are configured to cooperate to cause an initial rotation between the nut (17) and the plunger rod (19) as a result of the torsion member releasing its energy, wherein the first thread (19a) and the second thread (17d) are configured to engage after the initial rotation between the nut (17) and the plunger rod (19), to cause a further rotation between the nut (17) and the plunger rod (19) as a result of the torsion member releasing its energy, wherein the cam surface (17c) has a first helix angle (α), and the first thread (19b) and second thread (17d) have a second helix angle (β) which is larger than the first helix angle (α), the first helix angle (α) being the smallest angle between a first helix structure defined by the cam surface (17c) and a longitudinal axis (31) of the plunger rod (19), and the second helix angle (β) being defined as the smallest angle between a second helix structure formed by the first thread (19a) or the second thread (17d), and the longitudinal axis (31).

Description

[0001] DRIVE ASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to medicament delivery devices.

[0004] BACKGROUND

[0005] Medicament delivery devices such as autoinjectors may have a plunger rod which is moved forward by a power source inside the medicament container during drug delivery. The medicament container may contain a stopper, arranged axially between the plunger rod and the drug. The stopper is pushed forward, towards the needle, by the plunger rod during medicament administration.

[0006] Before drug delivery has been triggered, there is typically an axial gap between the plunger rod and the stopper. When triggered, the plunger rod is moved towards the stopper by the power source. As a result of the initial gap between the plunger rod and the stopper, the plunger rod gathers momentum before impacting the stopper. The impact can be very high for powerful devices configured to dispense a high viscous drug and / or configured to have low injection times.

[0007] Powerful medicament delivery devices often use a rotational power source to power the plunger rod to generate an even more powerful plunger rod force. The impact does not only create high stresses in components, but also the high free flight and low pitch, necessary for creating the required force, corresponds to many rotations of the torsion spring during the free flight. The torsion spring will thus reach a high rotational speed before it comes to an immediate halt upon impact. This abrupt stop of a high rotational speed creates a ripple effect in the torsion spring which can result in tangling of the torsion spring. SUMMARY

[0008] A general object of the present disclosure is to provide a drive assembly for a medicament delivery device which solves or at least mitigates the problems of the prior art.

[0009] There is hence according to a first aspect of the present disclosure provided a drive assembly for a medicament delivery device, comprising: a nut having a central through-opening, a plunger rod received in the through-opening, a torsion member configured to cause rotation of one of the nut and the plunger rod relative to the other one of the nut and the plunger rod when the torsion member releases its stored energy, wherein one of the nut and the plunger rod has a cam surface and the other one of the nut and the plunger rod has a follower configured to cooperate with the cam surface, wherein the plunger rod has a first thread and the nut has a second thread configured to cooperate with the first thread, wherein the cam surface and the follower are configured to cooperate to cause an initial rotation between the nut and the plunger rod as a result of the torsion member releasing its energy, wherein the first thread and the second thread are configured to engage after the initial rotation between the nut and the plunger rod, to cause a further rotation between the nut and the plunger rod as a result of the torsion member releasing its energy, wherein the cam surface has a first helix angle, and the first thread and second thread have a second helix angle which is larger than the first helix angle, the first helix angle being the smallest angle between a first helix structure defined by the cam surface and a longitudinal axis of the plunger rod, and the second helix angle being defined as the smallest angle between a second helix structure formed by the first thread or the second thread, and the longitudinal axis.

[0010] Due to the smaller first helix angle of the cam surface, the speed of rotation is reduced during the initial rotation compared to the further rotation, which is caused by the cooperation between the first thread and the second thread, with the larger second helix angle. The axial propagation speed of the plunger rod will thus be lower during the initial rotation than during the further rotation. This results in a lower impact speed with a stopper, and furthermore ensures that the rotational speed during the first axial displacement, or free flight, will be lower. Thus, the risk of damaging the torsion member may be reduced.

[0011] Furthermore, due to separate means of interaction provided by the cam surface and the follower, and the first and the second thread, to obtain different amounts of axial displacement of the plunger rod per revolution, the drive assembly will be more mechanically robust compared to a solution having a thread with varying pitch length interacting with a protrusion.

[0012] The first thread comprises a ridge which forms the thread structure. The ridge extends helically one or more turns. The second thread comprises a ridge which forms the thread structure. This ridge may extend helically one or more turns. At least one of the first thread and the second thread has a ridge that extends helically more than one turn. The ridge of the first thread and / or the second thread forms the aforementioned second helix structure.

[0013] According to one embodiment the cam surface and the follower engage at a first radius which is larger than a second radius at which the first thread and the second thread engage. Neither the first thread nor the second thread will thus be able to engage with the cam surface / follower as the plunger rod moves forward, i.e., in the proximal direction, relative to the nut.

[0014] According to one embodiment the drive assembly has a proximal end and a distal end, wherein the cam surface and the follower are located closer to the proximal end than the first thread and the second thread are located to the proximal end before the initial rotation has taken place.

[0015] According to one embodiment the cam surface and the follower are configured to be in engagement when the first thread and second thread engage. Thus, according to this example, the cam surface and the follower will for a certain amount of rotation be in engagement at the same time as the first thread and the second thread are in engagement with each other. This simultaneous engagement is only attained after the initial rotation has taken place. During the initial rotation, the first thread is not in engagement with the second thread.

[0016] In examples in which the first thread and the second thread are in engagement for a short while when the cam surface and follower are still in engagement, both the impact load and the static load shortly after impact are significantly reduced.

[0017] According to one embodiment the cam surface and the follower are configured to be in a disengaged state when the first thread and the second thread engage. According to this example, the cam surface and the follower disengage before the first thread and the second thread engage. As a result, the injection time will be shorter compared to if the first thread and the second thread engage for a short while at the same time as the cam surface and follower are engaged.

[0018] According to one embodiment the torsion member is a torsion spring.

[0019] According to one embodiment the first helix angle defines a pitch of the cam surface which is at least 5 times a pitch of the first thread and the second thread.

[0020] One embodiment comprises a medicament container and a stopper arranged in the medicament container, wherein the plunger rod is configured to push the stopper forward, in the proximal direction, in the medicament container.

[0021] According to one embodiment the plunger rod is arranged at a first axial distance from the stopper before the initial rotation of the nut or the plunger rod, wherein a second axial distance travelled by the plunger rod as a result of the initial rotation is about the same as the first axial distance.

[0022] According to one embodiment the second axial distance is the first axial distance plus / minus 5 mm, such as plus / minus 4 mm, such as plus / minus 3 mm, such as plus / minus 2 mm.

[0023] According to one embodiment the follower is a protrusion. There is according to a second aspect of the present disclosure provided a medicament delivery device comprising a drive assembly according to the first aspect.

[0024] The medicament delivery device may for example be an autoinjector.

[0025] One embodiment comprises a housing, wherein the nut is rotationally fixed relative to the housing.

[0026] 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, 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.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0029] Fig. 1 is a perspective view of a medicament delivery device;

[0030] Fig. 2 shows an exploded view of the medicament delivery device in Fig. 1

[0031] Fig. 3 shows a perspective view of components of a drive assembly;

[0032] Fig. 4 depicts a side view of a plunger rod and a longitudinal section of a nut;

[0033] Fig. 5 is a perspective view of the medicament delivery device in Fig. 1 in an initial state, with the rear part of the housing removed;

[0034] Fig. 6 shows a perspective view of components of a drive assembly in the initial state of the medicament delivery device;

[0035] Fig. 7 is a perspective view of the medicament delivery device in Fig. 5 in an activated state; and Fig. 8 shows a perspective view of components of drive assembly in the activated state of the medicament delivery device.

[0036] DETAILED DESCRIPTION

[0037] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like elements throughout the description.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] Fig. 1 is a perspective view of a medicament delivery device 1. The medicament delivery device 1 is an example of a device comprising an embodiment of a drive assembly according to the present disclosure.

[0042] The medicament delivery device 1 comprises a housing 3. The housing 3 may comprise a front part 3a and a rear part 3b.

[0043] The medicament delivery device 1 may have a removable cap. In Fig. 1, the cap has been removed.

[0044] The medicament delivery device 1 comprises a delivery member cover 5. The delivery member cover 5 is at least partly received by the housing 3. The delivery member cover 5 is configured to move along the longitudinal axis of the medicament delivery device 1. The delivery member cover 5 is configured to move between an extended position, shown in Fig. 1, and a retracted position relative to the housing 3. The delivery member cover 5 protrudes from the housing 3 in the extended position and is pushed further into the housing 3 in the retracted position.

[0045] The medicament delivery device 1 has a proximal end 7a and a distal end 7b. According to the example, a front end of the delivery member cover 5 defines the proximal end 7a when the cap has been removed and the delivery member cover 5 is in the extended position. The distal end 7b is the rear end of the medicament delivery device 1.

[0046] Fig. 2 is an exploded view of the exemplified medicament delivery device 1. The medicament delivery device 1 comprises a resilient member 9, configured to bias the delivery member cover 5 towards the extended position. The resilient member 9 may be a spring, such as a compression spring.

[0047] The medicament delivery device 1 comprises a container holder 11 configured to be axially and rotationally fixed relative to the housing 3.

[0048] The container holder 11 is configured to hold a medicament container 13, such as a syringe provided with a needle. The medicament container 13 contains the drug to be administered. A stopper 15 is slidably arranged in the medicament container 13. The stopper 15 keeps the distal end of the medicament container 13 sealed.

[0049] The medicament delivery device 1 comprises a drive assembly. The drive assembly comprises a nut 17, a plunger rod 19, and a torsion member 21. The torsion member 21 may for example be a torsion spring.

[0050] The plunger rod 19 has a first thread 19 a. The first thread 19 a is arranged on the outer surface of the plunger rod 19.

[0051] The medicament delivery device 1 comprises a release member 23, and a rotator 25. The medicament delivery device 1 may also comprise a rear cap assembly 27. The rotator 25 may form part of the drive assembly.

[0052] According to the example, one end of the torsion member 21 is connected to the rotator 25. The other end of the torsion member 21 is connected to one of the components of the rear cap assembly 27. The rear cap assembly 27 may be rotationally fixedly arranged relative to the housing 3. The torsion member 21 is configured to provide torsional bias of the rotator 25. The torsion member 21 is thus configured to cause rotation of the rotator 25.

[0053] The release member 23 is configured to maintain the rotator 25 rotationally fixed relative to the housing 3 when the delivery member cover 5 is in the extended position. The nut 17 may be provided with arms 17a, around which the release member 23 is arranged when the delivery member cover 5 is in the extended position. The arms 17a may have teeth configured to engage with corresponding teeth 25a on the outer surface of the rotator 25. The teeth of the arms and the teeth of the rotator may form a ratchet structure.

[0054] The release member 23 pushes the arms 17a radially inwards such that the ratchet structure locks and prevents rotation of the rotator 25. When the delivery member cover 5 is moved from the extended position to the retracted position, distally directed legs 5a, 5b of the deliver member cover 5 push the release member 23 in the distal direction, causing the release member 23 to move in the distal direction, away from the arms 17a, which as a result are flexed radially outwards. The rotator 25 is thus released from being rotationally locked, and the torsion member 21 will thus cause rotation of the rotator 25 as the torsion member 21 releases its stored energy.

[0055] The rotator 25 has an axial channel in which the plunger rod 19 is arranged to be at least partly received. The rotator 25 may have a keyed slot or keyway and the plunger rod 19 may have a corresponding keyseat engaging with the keyed slot or keyway. By rotation of the rotator 25, the plunger rod 19 is rotated concurrently with the rotator 25.

[0056] Fig. 3 shows a perspective view of the plunger rod 19, the nut 19, the medicament container 13, and the stopper 15 with the rest of the components of the medicament delivery device 1 hidden.

[0057] The plunger rod 19 extends through the nut 17 into the medicament container 13. The proximal end of the plunger rod 19 is arranged at a first axial distance d from the stopper 15 before the medicament delivery device 1 is triggered by the delivery member cover 5. The plunger rod 19 will thus have to travel the first axial distance d before impacting with the stopper 15. The first axial distance d is the distance of free flight of the plunger rod 19.

[0058] The plunger rod 19 is configured to move axially through the nut 17 into the medicament container 13 when the rotator 25 is being rotated by the torsion member 21. According to the present example, the nut 17 is configured to be arranged rotationally fixed relative to the housing 3. The nut 17 is configured to cooperate with the plunger rod 19 such that the plunger rod 19 is moved in the proximal direction further into the medicament container 13 by the rotation of the rotator 25, as will be explained in more detail in the following.

[0059] Fig. 4 shows a sideview of the plunger rod 19 and a longitudinal sectional view of the nut 17.

[0060] The nut 17 has a central through-opening 17b. The nut 17 is configured to receive the plunger rod 19 in the central through-opening 17b. The central through-opening 17b extends along the axis 29, which coincides with the longitudinal axis 31 of the plunger rod 19 when the plunger rod 19 is arranged in the central through-opening 17b.

[0061] According to the example in Fig. 4, the nut 17 has a cam surface 17c. The cam surface 17c is formed by a wall that defines the central through-opening 17b. The cam surface 17c extends helically around the axis 29. The cam surface 17c defines a first helix structure that has a first helix angle a. The first helix angle a is the smallest angle between the first helix structure and the axis 29.

[0062] The nut 17 has a second thread iyd. The second thread iyd is configured to cooperate with the first thread 19a of the plunger rod 19. The second thread iyd is arranged on the inner surface of the central through-opening 17b axially offset from the cam surface 17c. The second thread iyd defines a second helix structure that has a second helix angle p. The second helix angle P is the smallest angle between the second helix structure and the axis 29.

[0063] The first helix angle a is smaller than the second helix angle p.

[0064] The cam surface 17c and the second thread iyd are laid in the same direction. Thus, both the cam surface 17c and the second thread ijd are either right- handed threads or left-handed threads.

[0065] According to the example shown in Fig. 4, the cam surface 17c is arranged closer to a proximal end of the nut 17 than the second thread iyd is to the proximal end of the nut 17. The cam surface could alternatively be arranged more distally than the second thread. In this latter case, the cam surface may be arranged on a different component. The first thread 19a of the plunger rod 19 also defines a second helix structure that has the second helix angle p. The first thread 19a and the second thread iyd thus have the same helix angle. The second helix angle P of the first thread 19a is the smallest angle between the second helix structure of the first thread 19 a and the longitudinal axis 31 of the plunger rod 19.

[0066] According to the example, the plunger rod 19 has a follower 19b configured to cooperate with the cam surface 17c. The follower 19b may be a protrusion extending radially outwards.

[0067] The follower 19b is arranged axially spaced apart from the first thread 19a. The follower 19b may be arranged proximally relative to the first thread 19a.

[0068] It is to be noted that the cam surface and the follower could according to a variation change place, i.e., the cam surface maybe provided on the plunger rod and the follower may be provided on the nut. In this case, the follower would extend radially inwards.

[0069] Further, according to some examples, there may be two cam surfaces, arranged at a respective side of a central plane extending along the longitudinal axis 31 / axis 29, and two followers, each being configured to cooperate with a respective cam surface.

[0070] According to the example shown in Fig. 4, the follower 19b has a radial dimension which is larger than the largest cross-sectional dimension of the plunger rod 19 at one of the ridges of the first thread 19 a. The cam surface 17c and the follower 19b are thus in engagement and cooperate at a first radius, which is larger than a second radius at which the first thread 19 a and the second thread 17b engage.

[0071] The operation of the medicament delivery device 1 will now be described in more detail with reference to Figs 5-8.

[0072] Fig. 5 shows the medicament delivery device 1 without the rear part 3b of the housing 3 in an initial state of the medicament delivery device 1, i.e., before the medicament delivery device i has been triggered and the delivery member cover 5 is in the extended position relative to the housing 3.

[0073] In Fig. 6, the position of the cam follower 19b relative to the cam surface 17c is shown when the medicament delivery device 1 is in the initial state shown in Fig. 5. The follower 19b is located at the beginning of the cam surface 17c The follower 19b is thus located at a distal end of the cam surface 17c. The follower 19b is in contact with the cam surface 17c. The first thread 19 a is however not yet in engagement with the second thread 17b as they are axially spaced apart at this point.

[0074] In Fig. 7, the medicament delivery device 1 has been triggered and has thus reached an activated state. The delivery member cover 5 has been moved in the distal direction to the retracted position. Typically, this is done by holding the medicament delivery device 1 and pushing the delivery member cover 5 against the site of injection. As previously described, the movement of the delivery member cover 5 towards the retracted position causes it to move the release member 23 in the distal direction, towards the distal end of the medicament delivery device 1. As a result, the arms 17a of the nut 17 are released and allowed to flex radially outwards. The rotator 25, which has been rotationally locked by the arms 17a, is thus set free and the torsion member 21 causes the rotator 25 to rotate. The rotation of the rotator 25 in turn causes the plunger rod 19 to rotate. Due to the cooperation between the cam surface 17c and the follower 19b, the plunger rod 19 is moved in the proximal direction. The plunger rod 19 is thus moved forward relative to the rotator 25 and relative to the nut 17. The cam surface 17c with its first helix angle a in cooperation with the follower 19b at this stage controls the rotation and the linear displacement per revolution of the plunger rod 19. Thus, an initial rotation between the nut 17 and the plunger rod 19 is obtained. At this stage, the first thread 19 a and the second thread i d are not yet engaged.

[0075] As an alternative to the nut 17 being rotationally fixed relative to the housing 3, the plunger rod 19 may in one variation be rotationally fixed, and the nut may be configured to rotate relative to the housing. The cam surface 17c may for example have an axial length that is essentially equal to or is longer than the first axial distance d between the stopper 15 and the plunger rod 19 before the medicament delivery device 1 has been triggered. The free flight of the plunger rod 19 may in some examples not be equal to the distance d, as it may also include compression of air bubbles in the medicament container 13, and compression of the stopper 15. The plunger rod 19 may travel a second axial distance during the initial rotation, which is the entire rotation of the plunger rod 19 caused solely by the cooperation between the cam surface 17c and the follower 19b. The second axial distance maybe the first axial distance d, and for example plus / minus 5 mm, such as plus / minus 4 mm, such as plus / minus 3 mm, such as plus / minus 2 mm, such as plus / minus 1 mm.

[0076] After the initial rotation has been carried out, the first thread 19a and the second thread 17b engage. The torsion member 21 is still emptying its stored energy, causing a further rotation between the nut 17 and the plunger rod 19. Fig. 8 shows when the follower 19b is no longer in contact with the cam surface 17c after its travel along the cam surface 17c. The first thread 19a and the second thread i d, with their second helix angle P, have at this stage engaged, and control the rotation and the axial displacement per revolution of the plunger rod 19. The further rotation includes more revolutions of the plunger rod 19 than the number of revolutions during the initial rotation. According to one example the number of revolutions of the plunger rod 19 during the initial rotation may at most be a single revolution. The plunger rod 19, which after engagement of the first thread 19a and the second thread 17b is in contact with the stopper 15, moves towards the proximal end of the medicament delivery device 1 inside the medicament container 13, pushing the stopper 15 in the proximal direction. This results in that medicament is pushed out through the needle of the medicament container 13. Due to the larger second helix angle P, the axial force with which the plunger rod 19 acts on the stopper 15 will be larger than the axial force generated by the plunger rod 19 during the initial rotation. The engagement between the first thread 19 a and the second thread iyd may occur before the disengagement of the follower 19b from the cam surface 17c, as they disengage, or after they have disengaged.

[0077] 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.

[0078] 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, hidradenitis 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, Behqet'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 hypersensitivity reactions, 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.

[0079] 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.

[0080] 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.

[0081] 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-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci 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 (CD19) 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 W137 (CDW137) agonists, cluster of differentiation 158 (CD158) 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 (CD159 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 W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) 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, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies. 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-ia, interferon beta-ib, peginterferon beta-ia, 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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. 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, mF0LF0X6, mFOLFOXy, 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,

[0087] 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.

[0088] 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.

Claims

CLAIMS1. Drive assembly for a medicament delivery device (1), comprising: a nut (17) having a central through-opening (17b), a plunger rod (19) received in the through-opening (17b), a torsion member (21) configured to cause rotation of one of the nut (17) and the plunger rod (19) relative to the other one of the nut (17) and the plunger rod (19) when the torsion member (21) releases its stored energy, wherein one of the nut (17) and the plunger rod (19) has a cam surface (17c) and the other one of the nut (17) and the plunger rod (19) has a follower (19b) configured to cooperate with the cam surface (17c), wherein the plunger rod (19) has a first thread (19a) and the nut (17) has a second thread (i7d) configured to cooperate with the first thread (19a), wherein the cam surface (17c) and the follower (19b) are configured to cooperate to cause an initial rotation between the nut (17) and the plunger rod (19) as a result of the torsion member (21) releasing its energy, wherein the first thread (19a) and the second thread (iyd) are configured to engage after the initial rotation between the nut (17) and the plunger rod (19), to cause a further rotation between the nut (17) and the plunger rod (19) as a result of the torsion member (21) releasing its energy, wherein the cam surface (17c) has a first helix angle (a), and the first thread (19b) and second thread (ijd) have a second helix angle (P) which is larger than the first helix angle (a), the first helix angle (a) being the smallest angle between a first helix structure defined by the cam surface (17c) and a longitudinal axis (31) of the plunger rod (19),and the second helix angle (P) being defined as the smallest angle between a second helix structure formed by the first thread (19a) or the second thread (17b), and the longitudinal axis (31).

2. Drive assembly as claimed in claim 1, wherein the cam surface (17c) and the follower (19b) engage at a first radius which is larger than a second radius at which the first thread (19a) and the second thread (17b) engage.

3. Drive assembly as claimed in claim 1 or 2, wherein the drive assembly has a proximal end and a distal end, wherein the cam surface (17c) and the follower (19b) are located closer to the proximal end than the first thread (19a) and the second thread (17b) are located to the proximal end before the initial rotation has taken place.

4. Drive assembly as claimed in any of the preceding claims, wherein the cam surface (17c) and the follower (19b) are configured to be in engagement when the first thread (19a) and second thread (17b) engage.

5. Drive assembly as claimed in any of claims 1-3, wherein the cam surface (17c) and the follower (19b) are configured to be in a disengaged state when the first thread (19a) and the second thread (17b) engage.

6. Drive assembly as claimed in any of the preceding claims, wherein the torsion member (21) is a torsion spring.

7. Drive assembly as claimed in any of the preceding claims, wherein the first helix angle defines a pitch of the cam surface (17c) which is at least 5 times a pitch of the first thread (19a) and the second thread (17b).

8. Drive assembly as claimed in any of the preceding claims, comprising a medicament container (13) and a stopper (15) arranged in the medicament container (13), wherein the plunger rod (19) is configured to push the stopper (15) forward, in the proximal direction, in the medicament container (13).

9. Drive assembly as claimed in claim 8, wherein the plunger rod (19) is arranged at a first axial distance (d) from the stopper (15) before the initialrotation of the nut (17) or the plunger rod (19), wherein a second axial distance travelled by the plunger rod (19) as a result of the initial rotation is about the same as the first axial distance (d).

10. Drive assembly as claimed in claim 9, wherein the second axial distance is the first axial distance plus / minus 5 mm, such as plus / minus 4 mm, such as plus / minus 3 mm, such as plus / minus 2 mm.

11. Drive assembly as claimed in any of the preceding claims, wherein the follower (19b) is a protrusion.

12. Medicament delivery device (1) comprising a drive assembly as claimed in any of the preceding claims.

13. Medicament delivery device (1) as claimed in claim 12, comprising a housing (3), wherein the nut (17) is rotationally fixed relative to the housing

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