Patent Application
20250065048
The present disclosure generally relates to a sub-assembly of a medicament delivery device, and particularly to sub-assembly comprises a carrier retracting assembly.
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 a growth hormone.
There are types of medicaments that can be stored for a long time and that are filled in containers, such as cartridges, syringes, ampoules, canisters or the like, containing a ready-to-use medicament in a liquid state. However, other types of medicaments are a mixture of two substances, i.e. a medicament agent (e.g. lyophilized, powdered or concentrated liquid) and a diluent (e.g. water, dextrose solution or saline solution). These types of medicaments cannot be pre-mixed and stored for a long time because the medicament agent is unstable and can be degraded and lose its effect quickly. Hence, a user, e.g. a patient himself/herself, a physician, a nurse, hospital personnel or trained persons, must perform the mixing within a limited period prior to delivery of a dose of medicament to a patient. Further, some medicament agents are subject to chemical changes during mixing. Such sensitive medicament agents require a particular treatment when mixing with a diluent since excessive mixing force will degrade said medicament agents.
To facilitate the mixing, several containers for mixing have been developed to comprise at least two chambers, known as multi-chamber containers. These multi-chambered containers comprise at least a first chamber containing the medicament agent and a second chamber containing the diluent. These chambers are sealed off with stoppers so that the medicament agent is separated from the diluent and does not become degraded. When the medicament agent is to be mixed, shortly before administering, redirecting passages are opened between the chambers, usually by depressing a distal stopper and in turn a divider stopper of the container somewhat. The passages allow the mixing of the medicament agent and the diluent to prepare the medicament for delivery.
To facilitate for the patient to self-administer the medicament with a predetermined dose in an easy, safe and reliable way and also to facilitate the administration of medicaments for hospital personnel in the same facilitated way, several automatic and semi-automatic devices have been developed, incorporating these multiple-chamber solutions, to mix the medicament before delivery.
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 improvements, especially improvements regarding safely mixing the medicament and automatically using components and functions that are dedicated to a mixing sequence.
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 sub-assembly comprising: a tubular housing, a carrier, a cap, and a carrier retracting assembly; the tubular housing extends along a longitudinal axis between a distal end and a proximal end; the cap is removably attached to the tubular housing and at least partially enclosing the carrier; the carrier is configured to receive a medicament container of the medicament delivery device; and the carrier retracting assembly is configured to move the carrier relative to the tubular housing in the direction of the longitudinal axis from a proximal position where the carrier is at least partially arranged within the tubular housing to a distal position where the carrier is further into the tubular housing.
Preferably, according to another embodiment, the carrier retracting assembly comprises a pre-stressed resilient member; the pre-stressed resilient member is arranged between the carrier and the tubular housing and is configured to extend in the direction of the longitudinal axis; the carrier comprises a distally directed stop surface; the sub-assembly comprises a proximally directed stop surface adjacent to the distally directed stop surface of the carrier when the cap is attached to the tubular housing and is offset relative to the distally directed stop surface during the removal of the cap from the tubular housing, so that the carrier is moved from the proximal position to the distal position by the pre-stressed resilient member during the removal of the cap from the tubular housing.
Preferably, according to another embodiment, the tubular housing comprises a fastener; the cap comprises a counter fastener releasably attached to the fastener; and the cap is movable relative to the tubular housing between an attached position where the fastener is fixed to the counter fastener and a detached position where the fastener is not fixed to the counter fastener.
Preferably, according to another embodiment, the fastener and the counter fastener form a bayonet engagement or a screw engagement.
Preferably, according to another embodiment, the proximally directed stop surface is arranged on the cap.
Preferably, according to another embodiment, the sub-assembly comprises an adapter attached to a part of the cap; the proximally directed stop surface is arranged on the adapter; and the adapter is rotatable relative to the carrier around the longitudinal axis.
Alternatively, according to another embodiment, the proximally directed stop surface is arranged on the tubular housing; the cap is rotationally fixed to the carrier by a rotational engagement; and the cap is rotatable around the longitudinal axis relative to the tubular housing during the removal of the cap from the tubular housing.
Preferably, according to another embodiment, the carrier is rotationally fixed to the tubular housing by a rotational engagement.
Preferably, according to another embodiment, the rotational engagement is formed by at least one of a rib-and-rib engagement, a rib-and-recess engagement, and a rib-and-cut-out engagement.
Preferably, according to another embodiment, the tubular housing comprises a distally directed surface; the carrier comprises a proximally directed surface; and the pre-stressed resilient member engages with the distally directed surface of the tubular housing at a proximal end of the pre-stressed member and engages with the proximally directed surface of the carrier at a distal end of the pre-stressed member.
Preferably, according to another embodiment, the tubular housing comprises a proximally directed surface; wherein the carrier comprises a distally directed surface; and the pre-stressed resilient member engages with the distally directed surface of the carrier at a proximal end of the pre-stressed member and engages with the proximally directed surface of the tubular housing at a distal end of the pre-stressed member.
Preferably, according to another embodiment, the pre-stressed resilient member is a compression spring.
Preferably, according to another embodiment, the sub-assembly comprises a rod arranged within the tubular housing; the rod extends along the longitudinal axis between a proximal end and a distal end; the rod is fixed relative to the tubular housing in the direction of the longitudinal axis during the removal of the cap from the tubular housing; and the proximal end of the rod is configured to move a stopper of the medicament container when the carrier is in the distal position.
Preferably, according to another embodiment, the rod is configured to expel the medicament contained within the medicament container.
Preferably, according to another embodiment, the rod is configured to be at least partially surrounded by a spring that is configured to expel the medicament contained within the medicament container.
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 delivery device is an injection device, an inhalation device, or a medical sprayer.
Preferably, according to another embodiment, the medicament delivery device is an auto-injector.
Preferably, according to another embodiment, the medicament delivery device is a pen-shaped injector.
Preferably, according to another embodiment, the medicament delivery device comprises a reusable part and a disposable part.
Preferably, according to another embodiment, the disposable part of the medicament delivery device is a cassette where the tubular housing, the cap, the carrier and the carrier retracting assembly are parts of the cassette.
Preferably, according to another embodiment, the auto-injector is configured to provide a subcutaneous injection, an intramuscular injection, or an intravenous injection.
Another aspect of the invention provides a method of operating a medicament delivery device, the method comprising the steps of: providing a medicament delivery device comprising a tubular housing, a carrier receiving a medicament container, a cap, and a carrier retracting assembly; wherein the tubular housing extends along a longitudinal axis between a distal end and a proximal end; and wherein the cap is removably attached to the tubular housing and at least partially encloses the carrier; and removing the cap from the tubular housing, thereby triggering the carrier retracting assembly to retract the carrier further into the tubular housing.
Generally, 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 and/or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjögren'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, Behçet'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.
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.
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.
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, C1 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 OX40) 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.
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-1a, interferon beta-1b, peginterferon beta-1a, 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.
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.
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.
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.
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, 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, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.
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.
Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:
The sub-assembly can be used with a medicament delivery device comprising a prefilled syringe or can be used with a medicament delivery device comprising a cartridge that a user needs to attach a separate medicament delivery member to before use of the medicament delivery device.
The carrier retracting assembly is configured to retract the carrier 3 further into the tubular housing 1 during the removal of the cap 2 from the tubular housing 1. For example, the carrier is partially arranged within the tubular housing when the carrier is in the proximal position and is fully arranged within the tubular housing when the carrier is in the distal position. In this example, the cap can be transparent or be arranged with an observation aperture. In this example, if the disclosed sub-assembly is used with a prefilled syringe, the user can observe the medicament delivery member before use when the carrier is in the proximal position, so that the user can check whether the spray nozzle or the injection needle is damaged before use. Once the user removes the cap, the carrier will be retracted further into the tubular housing, namely, the carrier is moved to the distal position, so that the medicament delivery member can be shielded by the tubular housing to avoid any damage to the medicament delivery member and also avoid any injury to the user.
Furthermore, the disclosed sub-assembly can be used with a medicament delivery device that needs to expel any contained air within the medicament container, namely, needs a priming shot. Furthermore, the disclosed sub-assembly can also be used with a medicament container comprising more than one isolated chamber, namely, a multi-chamber medicament container. These chambers are usually isolated from one another by rubber stoppers. The sub-assembly can be used for performing an auto-mixing function of the substances in the different chambers. If the sub-assembly is used with a medicament delivery device that needs a priming shot and/or has an auto-mixing function, the sub-assembly further comprises a rod 6 arranged within the tubular housing 1. The rod is axially immovable relative to the tubular housing 1 when the auto-mixing and/or priming shot takes place. The rod can be configured to move into the medicament container and expel the medicament into the user's body. In this example, the rod will normally be called a plunger rod. Alternatively, the rod 6 can be configured to support the plunger rod or to support a spring that is configured to expel the medicament contained within the medicament container. In other words, the rod itself will not move in the proximal direction relative to the tubular housing to expel the contained medicament. In this example, the rod 6 will normally be called a guide rod 6. The plunger rod and the guide rod will be explained in detail later.
In an example where the disclosed sub-assembly is used for performing an auto-mixing function in a multi-chamber medicament container. The carrier retracting assembly is configured to move the carrier from the proximal position to the distal position during the removal of the cap from the tubular housing. Thereby, the rod of the sub-assembly can act on a stopper of the medicament container, the stopper is arranged at a distal end of the medicament container, when the carrier is in the distal position. Therefore, the substances contained within different chambers can be mixed. Similarly, if the disclosed sub-assembly is used for performing a priming shot, the rod of the sub-assembly acts on the stopper of the medicament container when the carrier is in the distal position, thus the contained air within the medicament container will be expelled.
Therefore, after the user removes the cap, the medicament of the medicament delivery device with the sub-assembly is ready to be used, e.g. fully mixed and/or primed, and no extra operation steps for mixing multiple substances and/or performing a priming shot are needed.
Furthermore, most multi-chamber medicament containers are cartridges, meaning that the user needs to attach a medicament delivery member before use. If the user attaches the medicament delivery member onto the medicament container before completing a mixing operation, then the medicament might leak via the medicament delivery member during the mixing operation, due to increased pressure within the medicament container. The disclosed sub-assembly uses the cap to enclose the carrier so that the user cannot access and attach a medicament delivery member onto the medicament container before mixing is carried out. Once the cap is removed, the mixing operation is also completed, since the carrier is retracted during the cap removal, meaning that the risk of medicament leakage can be mitigated.
In the example as shown in
Alternatively, the carrier retracting assembly can be formed in any suitable way to retract the carrier further into the housing during cap removal. For example, the carrier retracting assembly can be a gear wheel and racks. The gear wheel and the racks can both be arranged between the cap and the carrier, so that when the cap moves in the proximal direction, the gear wheel moves the carrier, via the rack, in the distal direction to the distal position. Alternatively, the carrier retracting assembly can be a motor gear with a switch configured to be switched on by the cap removal so that the motor gear can move the carrier to the distal position once the switch has been switched on.
In one example where the retracting assembly comprises a pre-stressed resilient member, the cost of the sub-assembly can be reduced in comparison with the example where the retracting assembly comprises a gear wheel and racks or comprises a motor gear and switch.
It should be noted that how far the carrier should be retracted further into the housing (i.e. the distance between the proximal position and the distal position measured in the direction of the longitudinal axis L) is dependent on the design. For example, if the sub-assembly is used in a medicament delivery device that is configured to retract a prefilled syringe further into the housing during cap removal, then the retraction distance of the carrier should be equal or greater than the length of the medicament delivery member. For example, the medicament delivery member is an injection needle with a length 13 mm. The retraction distance of the carrier can then be set as 15 mm for the injection needle with the length 13 mm. Alternatively, if the sub-assembly is used in a medicament delivery device to perform a priming shot, the retraction distance of the carrier is dependent on the volume of a priming shot, which is usually dependent on the contained medicament and the process of medicament filling, e.g. how much gas will be generated or how much air will be sealed within the medicament container. Alternatively, if the sub-assembly is used in a medicament delivery device, the sub-assembly is configured to perform an auto-mixing operation, and the retraction distance of the carrier is dependent on the length needed for squeezing the substance in one or two chambers fully into another chamber. The length is dependent on the types of substances, e.g. liquid or powder, viscosity, volume, along with how many chambers are provided. The retraction distance of the carrier can be fixed by any suitable arrangement. For example, the retraction distance of the carrier can be fixed by arranging a rib and groove between an outer surface of the carrier and an inner surface of the tubular housing. Alternatively, the retraction distance of the carrier can be fixed by the carrier retracting assembly. For example, if the carrier retracting assembly comprises a gear wheel and a rack, the retraction distance of the carrier can be fixed by the length of the rack or the number of teeth on the gear wheel. In another example, the retraction distance of the carrier can be varied by varying the accumulated force of the pre-stressed resilient member.
A detailed description of a preferred embodiment of the disclosed sub-assembly is set forth below.
As shown in
The carrier 3 is configured to receive a medicament container of the medicament delivery device and is partially arranged within the tubular housing 1 from the proximal end of the tubular housing 1, as shown in
The cap 2 is removably attached to the tubular housing 1 and partially encloses the carrier 3, as shown in
The carrier retracting assembly is configured to move the carrier 3 from the proximal position to the distal position during the removal of the cap from the tubular housing 1. In the preferred embodiment, the carrier retracting assembly comprises the pre-stressed resilient member 4 arranged between the carrier 3 and the tubular housing 1, as shown in
The distally directed stop surface 32 of the carrier 3 can be defined by a distal edge of the carrier, a protrusion 33 on an outer surface of the carrier 3, as shown in
In one example, the proximally directed stop surface 12 is arranged on the tubular housing 1, as shown in
In another example the proximally directed stop surface 51 is arranged on the adapter 5, as shown in
Furthermore, in the example where the proximally directed stop surface 51 is arranged on the adapter 5, the sub-assembly doesn't need to arrange with the fastener on the tubular housing and the counter fastener on the cap as mentioned above, because the engagement between the distally directed stop surface on the carrier and the proximally directed stop surface on the cap or the adapter can keep the cap attached to the tubular housing.
It should be noted that the proximally directed stop surface as described above is also suitable for being arranged on the cap.
It should be noted that, the proximally directed surface can be arranged on any suitable component that is axially immovable relative to the housing at least before the removal of the cap from the housing. As mentioned above, the proximally directed stop surface can be arranged on the cap, on the tubular housing or on an adapter that attaches to the cap. The proximally directed stop surface can be defined by a ledge extending from an inner surface of a sidewall of the cap, the tubular housing or the adapter; or a recess/cut-out that is arranged in the wall of the cap, the tubular housing or the adapter 5.
The proximally directed stop surface is configured to block the distal movement of the carrier 3 in the direction of the longitudinal axis relative to the tubular housing 1, against a force from the pre-stressed resilient member 4 that moves the carrier 3 in the distal direction relative to the tubular housing 1. A relative rotation around the longitudinal axis L between the proximally directed stop surface and the distally directed stop surface 32 of the carrier 3 is triggered during the removal of the cap 2 from the tubular housing 1.
In an example where the cap 2 is configured to be removed from the tubular housing 1 by a rotation around the longitudinal axis and an axial movement in the proximal direction relative to the tubular housing 1, the proximally directed stop surface can be arranged on the cap, the housing or the adapter 5. In a preferred example, the proximally directed stop surface is offset relative to the distally directed stop surface 32 when the cap 2 is rotated relative to the tubular housing 1 around the longitudinal axis L. In an example where the proximally directed stop surface 51 is arranged on the cap or the adapter, the cap 2 is rotatable relative to the carrier, so that when the cap 2 is rotated relative to the tubular housing 1 around the longitudinal axis L for initiating the cap removal, the rotation of the cap 2 places the proximally directed stop surface 51 offset relative to the distally directed stop surface 32 of the carrier 3 in the direction of the longitudinal axis L.
Furthermore, as shown in
Furthermore, in one example where the proximally directed stop surface 51 is arranged on the adapter 5, which is the component that attaches to the cap 2, the cap can be arranged to be removed from the housing by either a rotational movement and an axial movement or only an axial movement. For example, the adapter (e.g. a ring, a circlip, or a cylinder), is arranged within the cap. In one example, the adapter comprises a helical track or a helical cam surface; and the cap comprises a protrusion extending from an inner surface of a sidewall of the cap. The protrusion of the cap is configured to engage with the helical track or the helical cam surface. Therefore, during the cap removal from the tubular housing, the protrusion of the cap will move along the helical track or helical cam surface, thereby the axial movement of the cap rotates the adapter. The rotation of the adapter positions the proximally directed stop surface at an offset relative to the distally directed stop surface of the carrier. Alternatively, the cap can be arranged with the helical track or the helical cam surface, and the adapter can be arranged with the protrusion, dependent on the design choice.
In another example, the adapter 5 is rotated by the rotation of the cap 2 relative to the tubular housing. In this example, the adapter can be simply fixed to the cap or can be arranged to rotate with a different rate or rotational angle relative to the cap than relative to the tubular housing. In one example where the adapter is fixed to the cap, this example can provide manufacturing efficiency since the cap can be standardized for most medicament delivery devices. In one example where the adapter is arranged to rotate with a different rate or rotational angle relative to the cap than relative to the tubular housing, this example can provide greater design flexibility. For example, the adapter is arranged with a circumferential groove and the cap comprises a protrusion positioned within the groove so that the cap rotates relative to the adapter first, then contacts an edge of the groove, then the cap and the adapter can rotate together. In this example, if the user starts to twist the cap but then immediately decides not to carry out a medicament delivery operation, the retraction of the carrier will not be triggered. Alternatively, a similar effect can be provided by the design of the length of the proximally directed stop surface in a circumferential direction.
In one example, the carrier retracting assembly comprises the pre-stressed resilient member 4 arranged between the carrier and the tubular housing. In one example, the pre-stressed resilient member is a compression spring 4, as shown in
Alternatively, the pre-stressed resilient member is a flexible arm arranged between the tubular housing and the carrier in the direction of the longitudinal axis L. Alternatively, the pre-stressed resilient member 4 is a tension spring.
In one example where the pre-stressed resilient member is a tension spring, the tension spring extends along the longitudinal axis L between a proximal end and a distal end. The tubular housing comprises a proximally directed surface and the carrier comprises a distally directed surface. The pre-stressed resilient member engages with the distally directed surface of the carrier at its proximal end and engages with the proximally directed surface of the tubular housing at its distal end. Therefore, when the distally directed stop surface of the carrier is offset relative to the proximally directed stop surface (e.g. on the housing, on the cap or on the adapter), the tension spring can pull the carrier further into the tubular housing. The tension spring can be a coil tension spring or a stressed band spring, for example.
Another example of the sub-assembly of the invention as shown in
Thus, flexible wall 20′ is at partially adjacent to the inner wall 10′ of the tubular housing 1′ when the cap 2′ is attached to the tubular housing 1′. The cap 2′ comprises a protrusion extending from the flexible wall towards the longitudinal axis L. The protrusion 31′ defines a proximally directed surface. The carrier 3′ comprises a distally directed surface. In one example, the carrier 3′ comprises a protrusion 30′ extending towards the flexible wall of the cap 2′ and the distally directed surface is defined by the protrusion of the carrier 3′. Alternatively, a recess/cut-out is arranged in the carrier and open towards the flexible wall of the cap. In this example, the distally directed surface is defined by an edge of the recess/cut-out.
As shown in
In this example, the carrier retracting assembly comprises a resilient member 4′, e.g., a compression spring 4′. The compression spring 4′ is extending from a proximally directed surface of the carrier 3′ to a distally directed surface of the tubular housing 1′, and the compression spring 4′ is compressible between the proximally directed surface of the carrier 3′ to the distally directed surface of the tubular housing 1′. In this example, the cap 2′ is configured to be removed from the tubular housing 1′ by being moved in the proximal direction relative to the tubular housing 1′. In a preferred example, the cap 2′ is configured to be manually pulled by a user in the proximal direction relative to the tubular housing 1′. When the flexible wall 20′ of the cap 2′ is adjacent to the inner wall 10′ of the tubular housing 1′, the inner wall 10′ of the tubular housing 1′ blocks the flexible wall of the cap 2′ from flexing radially outwards relative to the longitudinal axis L, as shown in
It should be noted that instead of arranging the compression spring 4′ between the carrier 3′ and the housing 1′, the compression spring 4′ can be arranged between the carrier 3′ and other component. For example, the sub-assembly comprises a medicament delivery member guard 8. The medicament delivery member guard 8 is telescopic relative to the proximal end of the tubular housing 1′. The medicament delivery member guard 8 is configured to surround a medicament delivery member of the medicament delivery device, e.g., an injection needle, before and after a medicament delivery operation, so that the medicament delivery member can be prevented from being contaminated and the user can be prevented from any injury by the medicament delivery member. In this example, instead of the housing 1′, the carrier retracting assembly comprises a compression spring 4′. The compression spring 4′ is extending from a proximally directed surface of the carrier 3′ to a distally directed surface 80 of the medicament delivery member guard 8, and the compression spring 4′ is compressible between the proximally directed surface of the carrier 3′ to the distally directed surface 80 of the medicament delivery member guard 8. In this example, the compression spring 4′ can provide two functions, both for retracting the carrier 3′ further into the tubular housing 1′ and moves the medicament delivery member guard 8 out of the tubular housing 1′, so that the medicament delivery member guard 8 can surround the medicament delivery member.
In a preferred example, the flexible wall 20′ of the cap 2′ is a flexible arm.
Furthermore, instead of pulling the cap relative to the tubular housing, the cap can be rotated around the longitudinal axis relative to the tubular housing and moved in the proximal direction of the tubular housing. For example, the cap is attached to the tubular housing with a thread engagement, or a helical cam interface formed between the cap and the tubular housing.
In another example, when the medicament container is a cartridge, the sub-assembly comprises a medicament delivery member assembly 9. As shown in
In a preferred example, the medicament delivery member 91 is an injection needle.
It should be noted that the first predetermined distance can be the same or different to the second predetermined distance dependent on the design.
Furthermore, in a preferred example, the carrier 3′ comprises a proximally directed support surface 32′ configured to be adjacent to the distal end of the medicament container. Additionally, the carrier 3′ optionally comprises a distally directed support surface 33′ configured to be adjacent to a proximal shoulder of the medicament container.
In one example where the sub-assembly is capable of performing an auto-mixing or priming, the sub-assembly comprises the rod 6. The rod 6 is arranged within the tubular housing 1. The rod 6 extends along the longitudinal axis L between a proximal end and a distal end. The rod 6 is fixed relative to the tubular housing 1 in the direction of the longitudinal axis during the removal of the cap from the housing 1. The proximal end of the rod 6 is configured to move a stopper of the medicament container when the carrier 3 is in the distal position, as shown in
In the example as shown in
In one example where the rod is the guide rod, this example is suitable for being used with a medicament delivery device where the plunger rod is always subjected to a force for expelling the contained medicament, such as a linear spring force. This is because when the plunger rod is pushed by the stopper of the medicament container during the retraction of the carrier, the pushing force might cause the plunger rod to disengage with a holding member (this will be explained in detail later) so that an unintentional trigger of the medicament delivery operation might occur if the plunger rod is always subjected to a force for expelling the contained medicament. In one example where the rod is the plunge rod, this example is suitable for being used with a medicament delivery device that the plunger rod is not always subjected to a force for expelling the contained medicament, such as a motor-driven power source or a gas propellant power source. Because those power sources usually will not output a force to the plunger rod unless the medicament delivery device is triggered.
In the example as shown in
The disclosed sub-assembly can be used with a medicament delivery device comprising a drive mechanism. The drive mechanism of the medicament delivery device comprises a power source, a force transferring member and a trigger assembly. The power source is configured to provide a force for expelling the contained medicament of the medicament delivery device. The force transferring member is configured to transfer the force from the power source to the medicament container. The trigger assembly is configured to either releasably hold the force transferring member or control the output force from the power source.
In the preferred example as shown in
The button 75 is configured to move the flexible arm 732a of the actuator 73 axially offset relative to the sleeve body of the actuator sleeve 74 when the button 75 is moved from the initial position to the triggered position. In one example, the button 75 is configured to engage and move the body 731, 732 of the actuator 73 out from the body sleeve of the actuator sleeve 74. Optionally, in this example, the body 731, 732 is formed by a proximal body 732 and a distal body 731. The flexible arm 732a extends from the proximal body 731. The distal body 731 comprises a resilient arm 731a extending from the distal body 731. The resilient arm 731a comprises a protrusion 731b extending in the direction transverse to the longitudinal axis and a hook 731c comprising a proximally directed hook surface, as shown in
Alternatively, in another example, the button is configured to engage and move the plunger rod in the proximal direction of the tubular housing so that the plunger rod moves the body of the actuator out from the body sleeve of the actuator sleeve through the engagement between the plunger rod and the actuator. In a preferred example, the actuator is configured to surround the plunger rod. The plunger rod comprises an elongated body configured to releasably block the flexible arm of the actuator from flexing radially inward relative to the body of the actuator so that the actuator is engaged with the actuator sleeve and prevented from being moved in the distal direction of the tubular housing until the elongated body of the plunger rod moves out from the body of the actuator.
In another example, the medicament delivery device with the drive mechanism as mentioned above comprises an indication mechanism. In this example, the plunger rod spring 72 is arranged between the plunger rod 71 and the actuator 73, as shown in
It should be noted that instead of the above-mentioned example, the drive mechanism of the medicament delivery device can be formed in any other suitable way. For example, instead of the plunger rod spring, the power source can be other types of springs, e.g. a torsion spring or a band spring. Alternatively, the power source can be a motor or a gas canister. Similarly, instead of being arranged within the tubular housing 1 as in the above-mentioned examples, the drive mechanism can be packed in an independent power pack housing that connects to the tubular housing. In the example as shown in
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 other aspects of the invention are defined by the following clauses.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21211825.1 | Jan 2022 | EP | regional |
The present application is a U.S. National Phase Application pursuant to 35 U.S.C. § 371 of International Application No. PCT/EP2022/087673 filed Dec. 23, 2022, which claims priority to (i) European Patent Application No. 21211825.1 filed Jan. 7, 2022, and (ii) U.S. Provisional Patent Application No. 63/406,408 filed Sep. 14, 2022. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/087673 | 12/23/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63406408 | Sep 2022 | US |
