A container assembly of a medicament delivery device

Abstract

A container assembly of a medicament delivery device, the container assembly comprising: a container carrier accommodating a first medicament container and a second medicament container; wherein the first medicament container comprises a first body configured to accommodate a first fluid and a first exit where the first fluid can be expelled from the first exit; wherein the first medicament container comprises a first valve assembly positioned between the first body and the first exit; wherein the first valve assembly is configured to establish a fluid communication between the first body and the first exit when fluid pressure within the first body meets a first pressure threshold; wherein the second medicament container comprises a second body configured to accommodate a second fluid and a second exit where the second fluid can be expelled from the second exit; wherein the second medicament container comprises a second valve assembly positioned between the second body and the second exit; wherein the second valve assembly is configured to establish a fluid communication between the second body and the second exit when fluid pressure within the second body meets second pressure threshold; and wherein the first pressure threshold is lower than the second pressure threshold.

Description

[0001] TITLE

[0002] A container assembly of a medicament delivery device

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to a container assembly of a medicament delivery device, and particularly to a container assembly with first medicament container containing a first fluid and a second medicament container containing a second fluid.

[0005] BACKGROUND

[0006] 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 administrating high volume and / or viscosity medicament, or multiple different medicaments, a motor-driven medicament delivery device is desirable.

[0007] Many motor-driven systems exist to deliver medicaments, as in the case of parenteral delivery. For instance, peristaltic drives or piston pumps are common in the art. However, motor-driven medicament delivery systems have disadvantages in some applications. These disadvantages can become pronounced when considering a device that can deliver multiple medicaments, as in the case of a device that is configured to administer sequential medicament regimens without the in-process intervention of a healthcare professional (HCP). Additionally, in-line pumping elements often include silicone oil as means of lubrication, which while largely inert, can introduce potential drug stability considerations when particularly sensitive medicaments are delivered through them.

[0008] In some cases, multiple medicaments must remain fluidically separate to prevent mixing of medicaments and potential compatibility issues between medicaments and / or medicament formulation components (i.e. , excipients) that may cause unintended or undesirable effects (e.g., loss of potency, efficacy, or aggregation). While a single medicament device need not be concerned with this, this no longer holds true when the drug delivery device is intended to deliver two or more drug products. Alternatively, in some case, multiple medicaments intended for the subcutaneous space may need to be administered to a single injection site, particularly in the case of a drug product paired with a tissue dispersion enhancer. Dispersion enhancers, such as hyaluronidase, may be delivered to an injection site prior to administration of a therapeutic medicine.

[0009] This is advantageous when a dispersion enhancer is separate from the formulation and is administered to an injection site prior to administration of a high-volume biologic, as in the example of hyaluronidase followed by immune globulin. The hyaluronidase is administered, a 15 minute delay is provided for in the instructions, then the IG is administered. In this example, two separate devices (a syringe and a pump) are used to deliver each drug, respectively.

[0010] In some cases, separate dispersion enhancer and therapeutic medication may be provided when co-formulation is not possible, it is advantageous to use a single power source of the medicament delivery device to administer both drugs, since they are each provided separately out of necessity. Both medications can be accommodated without increasing the size and cost of the power source of the medicament delivery device; if a device requires a separate motor or pump for each additional medication, the power requirement, size, complexity, and cost of the device in each application becomes potentially infeasible to manage, especially during final configuration and assembly of the device (i.e. , dispensing) by a pharmacist.

[0011] It is further advantageous to provision the shared power source of the medicament delivery device with access to both medicaments at the beginning of the treatment instance to reduce administration workflow complexity. The user, who may be the patient in a home setting rather than a trained health care provider, would otherwise be responsible for swapping the drug container that is paired with the power source of the medicament delivery device in order to switch between administration of each drug. In this use case, errors such as omitted injection of the dispersion enhancer, incorrect administration timing, or swapped administration order are more likely to occur.

[0012] Having both medicaments attached to the power source of the medicament delivery device at the beginning of treatment and the device configured for the full treatment also facilitates more seamless use of a single tube set that enforces use of a single injection site for both drugs. This ensures that patient anatomy (e.g., subcutaneous space) prepared by the dispersion enhancer is subsequently used for delivery of the succeeding medication. This could be accomplished with pre-bundling of two discrete tubes, a double lumen tube, or even a single tube set and needle, where the second drug is allowed to contact residue of the first drug in the flow path.

[0013] While a power source of the medicament delivery device could be provisioned with electronic valves to switch between administration of each attached drug, this burdens the device with additional connections and electronic components and limits its suitability as a platform that is still attractive for single drug regimens. Thus, there is a need for solutions to facilitate sequential administration of multiple medicaments from a single container carrier without complex fluidic (i.e., valving) components that add cost and complexity, while still being intuitive for untrained users, as may be present during home or self-administration of medication.

[0014] SUMMARY

[0015] The invention is defined by the appended claims, to which reference should now be made.

[0016] There is hence provided a container assembly of a medicament delivery device, the container assembly comprising: a container carrier accommodating a first medicament container and a second medicament container. The first medicament container comprises a first body configured to accommodate a first fluid and a first exit where the first fluid can be expelled from the first exit; wherein the first medicament container comprises a first valve assembly positioned between the first body and the first exit; wherein the first valve assembly is configured to establish a fluid communication between the first body and the first exit when fluid pressure within the first body meets a first pressure threshold. The second medicament container comprises a second body configured to accommodate a second fluid and a second exit where the second fluid can be expelled from the second exit; wherein the second medicament container comprises a second valve assembly positioned between the second body and the second exit; wherein the second valve assembly is configured to establish a fluid communication between the second body and the second exit when fluid pressure within the second body meets second pressure threshold. The first pressure threshold is lower than the second pressure threshold. Thus, the delivery sequence, e.g., delivering the first fluid, then waiting for 15 minutes, then delivering the second fluid... etc., between the first fluid and the second fluid can be controlled simply by force applied to both the first medicament container and the second medicament container.

[0017] Preferably, according to another embodiment, the container assembly is configured to be used with a portable medicament delivery device.

[0018] Preferably, according to another embodiment, the first valve assembly comprises a first one-way valve; and the second valve assembly comprises a second one-way valve.

[0019] Preferably, according to another embodiment, the first and the second one-way valve is a single-use valve, e.g., a frangible valve.

[0020] Preferably, according to another embodiment, the first and the second one-way valve is an umbrella or duckbill-style elastomeric valve.

[0021] Preferably, according to another embodiment, the first one-way valve has a first cracking pressure value; and the second one-way valve has a second cracking pressure valve. The first cracking pressure value is lower than the second cracking pressure value.

[0022] Preferably, according to another embodiment, viscosity of the first fluid is lower than the second fluid. In this embodiment, the first one-way valve and the second oneway valve have the same cracking pressure.

[0023] Preferably, according to another embodiment, at least one of the first valve assembly and the second valve assembly comprises a flow conditioner. The flow conditioner is configured to increase or decrease the fluidic resistance between the first and / or second body and the first and / or second exit.

[0024] Preferably, according to another embodiment, the flow conditioner can be an extra orifice, a pinch valve, or a bypass fluid pass.

[0025] Preferably, according to another embodiment, the first body of the first medicament container is a flexible bag. Preferably, according to another embodiment, the second body of the second medicament container is a flexible bag.

[0026] Preferably, according to another embodiment, the container carrier comprises a fluid inlet configured to be connected to a fluid pressure power source such that fluid from the fluid pressure power source can flow into the container carrier and increase pressure within the first body and the second body respectively until the first pressure threshold and the second pressure threshold are met.

[0027] Preferably, according to another embodiment, the container carrier is fluid-tight.

[0028] Preferably, according to another embodiment, the fluid pressure power source is a pneumatic power source or a hydraulic power source. The pneumatic power source is configured to output gas to the container carrier and expel the medicament contained within the first and the second medicament container by pressing the first and the second container with the outputted gas such that the fluid pressure within the first and the second container is increased. The hydraulic power source is configured to output liquid to the container carrier and expel the medicament contained within the first and the second medicament container by pressing the first and the second container with the outputted liquid such that the fluid pressure within the first and the second container is increased. When the fluid pressure power source is the pneumatic power source, the container carrier is gas-tight. When the fluid pressure power source is hydraulic power source, the container carrier can be either gas-tight or liquid-tight.

[0029] Preferably, according to another embodiment, the first body of the first medicament container comprises an inlet. The second exit of the second medicament container is connected to the inlet of the first body. The first exit is configured to be connected to a medicament delivery member.

[0030] Preferably, according to another embodiment, the first exit is configured to be connected to a first conveying member, and the second exit is configured to be connected to a second conveying member.

[0031] Preferably, according to another embodiment, the first conveying member and the second conveying member are connected to a medicament delivery member. Preferably, according to another embodiment, the first conveying member is a first delivery tube; and wherein the second conveying member is a second delivery tube.

[0032] Preferably, according to another embodiment, the medicament delivery member is an injection needle or a soft cannula.

[0033] Preferably, according to another embodiment, the first conveying member and the second conveying member are both connected to one medicament delivery member.

[0034] Preferably, according to another embodiment, the container carrier comprises a release valve configured to be manually opened or open when a third pressure threshold is met; and wherein the third pressure threshold is higher than the first and the second pressure thresholds.

[0035] Preferably, according to another embodiment, the release valve is connected to an emergency button. The release valve is configured to release the fluid flowing within the container carrier to the ambient or a receiving container included in the container carrier or the medicament delivery device when the emergency button is activated, thus, to cease the motivation of the first and the second fluid contained within the first and the second container respectively.

[0036] Preferably, according to another embodiment, the emergency button can be pressed, or pulled, or slid, or twisted relative to the container carrier or the reusable body of the medicament delivery device for activating the emergency button.

[0037] Alternatively, according to another embodiment, the release valve is configured to slow down the medicament delivery rate.

[0038] Alternatively, according to another embodiment, the release valve is connected to a tuned orifice.

[0039] Preferably, according to another embodiment, the container carrier comprises a flexible bag adjacent to both the first medicament container and the second medicament container; wherein the flexible bag comprises a fluid inlet configured to be connected to a fluid pressure power source such that fluid from the fluid pressure power source can flow into the flexible bag and increase pressure within the first body and the second body respectively until the first pressure threshold and the second pressure threshold are met.

[0040] Preferably, according to another embodiment, the container assembly is a cassette of the medicament delivery device.

[0041] Preferably, according to another embodiment, the container assembly of the cassette is disposable.

[0042] Preferably, according to another embodiment, the cassette is configured to be attached to the reusable body of the medicament delivery device.

[0043] Preferably, according to another embodiment, the cassette is configured to be releasably attached to the reusable body of the medicament delivery device.

[0044] Preferably, according to another embodiment, the container carrier comprises a pressure sensor.

[0045] Another aspect of the invention provides a medicament delivery device comprising the container carrier.

[0046] Preferably, according to another embodiment, the medicament delivery device is portable.

[0047] Preferably, according to another embodiment, the medicament delivery device is body worn, underneath or over clothing.

[0048] Preferably, according to another embodiment, the container carrier comprises a wearable feature.

[0049] Preferably, according to another embodiment, the reusable body of the medicament delivery device comprises a wearable feature.

[0050] Preferably, according to another embodiment, the wearable feature is a strap, a belt, a clip, a garment, or a band.

[0051] Preferably, according to another embodiment, the medicament delivery device is an injection device, e.g., an infusion device or an on-body injector. Preferably, according to another embodiment, the medicament delivery device comprises the reusable body and a changeable medicament delivery member.

[0052] Preferably, according to another embodiment, the medicament delivery device comprises a processor electrically connected to the fluid pressure power source, an electrical power source connected to the processor. The processor and the electrical power source are accommodated within the reusable body.

[0053] Preferably, according to another embodiment, the medicament delivery device comprises a user interface attached to the reusable body.

[0054] Preferably, according to another embodiment, the user interface is electrically connected to the processor.

[0055] Preferably, according to another embodiment, the user interface is a button protruding from an outer surface of the reusable body.

[0056] Preferably, according to another embodiment, the user interface is a screen or touch panel arranged on an outer surface of the reusable body.

[0057] Preferably, according to another embodiment, the medicament delivery device comprises a display.

[0058] Preferably, according to another embodiment, the medicament delivery device comprises an orientation sensor such that the display, the screen, or the touch panel can always be presented in the right-reading graphic indicia to a user.

[0059] Preferably, according to another embodiment, the medicament delivery device comprises a wireless communication receiver connected to the processor. The wireless communication receiver can be based on the technology of radio frequency identification (RFID), near-field communication (NFC), Bluetooth, Bluetooth low energy (BLE), Ultra wide band (UWB), wireless fidelity (Wi-Fi), cellular communication, and infrared (IR), as non-limiting examples.

[0060] Preferably, according to another embodiment, the wireless communication receiver is configured to receive a wireless signal from a remote device or an information tag. Preferably, according to another embodiment, the wireless communication transmitter is configured to transmit a wireless signal to a remote device or an information tag.

[0061] Preferably, according to another embodiment, the container carrier comprises the information tag containing information about the medicament delivery sequence between multiple medicaments contained within the container carrier.

[0062] Preferably, according to another embodiment, the processor is configured to control the fluid pressure power source to output fluid to the container carrier in different flow rates dependent on the information about the medicament delivery sequence between multiple medicaments contained within the container carrier.

[0063] Preferably, according to another embodiment, the fluid pressure power source comprises a piezo pump configured to cause fluid to output from the fluid pressure power source. Furthermore, the piezo pump is preferably used as the pneumatic power source. Using a piezo pump can be advantageous as it can provide quiet or silent operation and can provide lower power operation when compared to motor- driven solutions.

[0064] Preferably, according to another embodiment, the fluid pressure power source comprises a motor-based fluid pump configured to cause fluid to output from the fluid pressure power source.

[0065] Preferably, according to another embodiment, the fluid pressure power source comprises a piston pump when lower cost or complexity is desired.

[0066] Preferably, according to another embodiment, when the fluid pressure power source is the pneumatic power source, the pneumatic power source is a well-controlled diaphragm pump when lower cost or complexity is desired.

[0067] Preferably, according to another embodiment, when the fluid pressure power source is the pneumatic power source, the pneumatic power source comprises an electronic engine, e.g., a MEMS engine, and a liquid substance. In this example, the engine is configured to trigger an electro-chemical reaction of the liquid substance to generate propellant gas. Preferably, according to another embodiment, the fluid pressure power source a fluid pump having an inlet fluidly connected to the environment and an inlet filter connected to the inlet of the fluid pump comprises an inlet filter connected to the fluid pump such that contamination from the environment, e.g., dust, can be prevented from entering to the fluid pump.

[0068] Preferably, according to another embodiment, the fluid pressure power source comprises a pump-outlet check valve, followed by a downstream controllable release valve (venting to atmosphere), a flow sensor, a pressure sensor, an outlet filter connected to the fluid-tight chamber.

[0069] Preferably, according to another embodiment, the fluid pressure power source comprises a pressurized fluid canister configured to cause fluid to output from the fluid pressure power source.

[0070] Preferably, according to another embodiment, when the fluid pressure power source is the pneumatic power source, the pneumatic power source comprises a pressurized gas canister.

[0071] Preferably, according to another embodiment, the fluid pressure source is a pneumatic power source. In this embodiment, the fluid outputted from the fluid pressure power source is gas, e.g., air or nitrogen.

[0072] Preferably, according to another embodiment, the fluid pressure source is a hydraulic power source. In this embodiment, the fluid outputted from the fluid pressure power source is liquid, e.g., water or oil.

[0073] Preferably, according to another embodiment, the container carrier is operably connected to the pressure sensor and the flow rate sensor.

[0074] Preferably, according to another embodiment, the processor electrically connected to the pressure sensor and the flow rate sensor when the container carrier is attached to the reusable body of the medicament delivery device.

[0075] Preferably, according to another embodiment, the reusable body of the medicament delivery device comprises the communication unit configured to read an information tag on the container carrier when the container carrier is attached to the reusable body of the medicament delivery device. Preferably, according to another embodiment, the communication unit is electrically connected to the processor.

[0076] Preferably, according to another embodiment, the communication unit is an RFID / NFC reader and / or RFID / NFC writer.

[0077] In another embodiment, the first fluid and the second fluid contain a different medicament.

[0078] In one embodiment, the first fluid and the second fluid contain the same medicament, In that case, the first body may be pre-filled and sealed, and the second body is initially empty at the time of prefilling of the first body and user-filed (e.g. by a pharmacist or the patient themselves) at a later time with a smaller dose to customize the delivered dose, then sealed.

[0079] This configuration is advantageous in the context of dose escalation studies used in early clinical trials to establish the recommended dose of new drugs or drug combinations, where the goal is to avoid overexposures of patients to the drug. These so-called “up-and-down” trial designs are common in oncology, aimed at escalating or de-escalating the dose with diminishing fractions of the preceding dose depending on the absence or presence of severe toxicity in the previous cohort of treated patients. These designs may also be guided by measurements of pharmacokinetic parameters, known as the pharmacologically guided dose escalation (PGDE) method.

[0080] This configuration is also advantageous in the context of weight-based drugs. It is for instance the case of Subcutaneous immunoglobulin (SCIg), used to treat primary immunodeficiency disease (PID) and Common Variable Immunodeficiency (CIVD). SCIg is often given in a weight-based dose, either for initiation of new patients, or as part of a dose adjustment. Because of the dosing of SCIg, it is often possible to standardize large-volume prefilled reservoirs. This allows large doses (e.g., 70mL or 100mL) to be readily assembled, but patients may need dose adjustments in between these volumes. For this reason, manufacturers provide vials and prefilled syringes in smaller sizes (e.g., 5, 10mL) that may be used to create “in between” doses in combination with the larger reservoirs (e.g., 20+50+5 = 75mL). This reflects common clinical practice, which is to round up or down weight based doses to the nearest 5mL. The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies and / or protein derivatives. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1 a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)) , ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.

[0081] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medicaments such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0082] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD- 1 / PD-L1 inhibitors / modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TOR therapies.

[0083] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medicament treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21 , Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811 , HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini- BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0084] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0085] 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.

[0086] BRIEF DESCRIPTION OF THE DRAWINGS

[0087] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0088] Figs 1-3 schematically show container assembly of the invention in three different embodiments; and Figs4A-4B show perspective views of the container assembly of the invention connected to a power source.

[0089] DETAILED DESCRIPTION

[0090] Figs 1-4B illustrate a container assembly 1 ; T of a medicament delivery device. The container assembly 1 ; T comprises a container carrier 10 accommodating a first medicament container 11; 1 T containing a first fluid and a second medicament container 12; 12’ containing a second fluid. The first fluid and the second fluid are configured to be sequentially delivered in a predetermined order. The first fluid and the second fluid can be delivered to the same medicament delivery site by the same medicament delivery member, e.g., an injection needle or a soft cannula; alternatively, the first fluid and the second fluid can be delivered to different medicament delivery sites by different medicament delivery members respectively. In a preferred example, the first fluid and the second fluid are different medicaments; alternatively, the first fluid and the second fluid can be the same.

[0091] The first medicament container 11 ; 1 T comprises a first body 11a; 11a’ configured to accommodate the first fluid and a first exit 11b; 11b’ where the first fluid can be expelled from the first exit 11b; 11b’. The first medicament container 11 ; 1 T comprises a first valve assembly 11c; 11c’ positioned between the first body 11a; 11a’ and the first exit 11b; 11b’. The first valve assembly 11c; 11c’ is configured to establish a fluid communication between the first body 11a; 11a’ and the first exit 11b; 11b’ when fluid pressure within the first body 11a; 11a’ meets a first pressure threshold. The second medicament container 12; 12’ comprises a second body 12a; 12a’ configured to accommodate the second fluid and a second exit 12b; 12b’ where the second fluid can be expelled from the second exit 12b; 12’. The second medicament container 12; 12’ comprises a second valve assembly 12c; 12c’; 12c” positioned between the second body 12a ;12a’ and the second exit 12b; 12b’. The second valve assembly 12c; 12c’; 12c” is configured to establish a fluid communication between the second body 12a; 12a’ and the second exit 12b; 12b’ when fluid pressure within the second body 12a; 12a’ meets second pressure threshold. The first pressure threshold is lower than the second pressure threshold.

[0092] In one example, the first valve assembly 11c; 11c’ comprises a first one-way valve 11c; 11c’; and the second valve assembly 12c; 12c’; 12c” comprises a second one- way valve 12c; 12c’; 12d”. In a preferred example, the first one-way valve 11c; 11c’ has a first cracking pressure value; and the second one-way valve 12c; 12c’ has a second cracking pressure valve. In this example, the first cracking pressure value is lower than the second cracking pressure value. Thus, the sequence of the medicament delivery can be controlled by the pressure built within the first and the second medicament containers 10. For example, there is no medicament will be delivered if the built pressure is lower than the first cracking pressure valve; the first fluid is expelled once the built pressure reaches the first cracking pressure value; and the both the first and the second fluid are expelled once the built pressure reaches the second cracking pressure valve. Thus, in the case that the first fluid has to be delivered to a user before the delivery of the second fluid, the sequence can be controlled by the built pressure value.

[0093] In another example, the first one-way valve and the second one-way valve have the same cracking pressure. When the viscosity of the first fluid being lower than the second fluid, the first fluid will be preferentially emptied from the first medicament container at lower built pressure without imposing a difference in valve crack pressures.

[0094] In another example, at least one of the first valve assembly 11c and the second valve assembly 12c” comprises a flow conditioner 12e”. The flow conditioner 12e” is configured to increase or decrease the fluidic resistance between the first and / or second body 11a, 12a and the first and / or second exit 11b, 12b. For example, the flow conditioner 12e” can be a pinch valve. In this example, the first one-way valve and the second one-way valve can have the same cracking pressure. In one example where the second valve assembly 12c” comprises the second one-way valve 12d” and the flow conditioner 12e”, the second pressure threshold is determined by the cracking pressure of the one-way valve and the flow conditioner.

[0095] In a preferred example, the first body 11a; 11a’ of the first medicament container 11; 1 T is a flexible bag, and the second body 12a’; 12a’ of the second medicament container 12; 12’ is a flexible bag. In this example, the container carrier 10 comprises a fluid inlet 13 configured to be connected to a fluid pressure power source 2 such that fluid from the fluid pressure power source can flow into the container carrier 10 and increase pressure within the first body 11a; 11a’ and the second body 12a; 12a’ respectively until the first pressure threshold and the second pressure threshold are met. In this example, the container carrier is fluid-tight. In one example where the container carrier 10 is configured to be connected to a pneumatic power source 2, the container carrier 10 is gas-tight. Alternatively, in one example where the container carrier is configured to be connected to a hydraulic power source, the container carrier is liquid-tight.

[0096] In one example, the first body 11a’ of the first medicament container 1 T comprises an inlet. The second exit 12b’ of the second medicament container 12’ is connected to the inlet of the first body 11a’, as shown in Fig. 3. The first exit 11b’ is configured to be connected to a medicament delivery member. In another example, as shown in Figs 1-2, the first exit 11b; 11b’ is configured to be connected to a first conveying member and the second exit 12b; 12b’ is configured to be connected to a second conveying member. In one example, the first conveying member is a first delivery tube, and the second conveying member is a second delivery tube. In one example, the medicament delivery member is an injection needle or a soft cannula.

[0097] In another example, the container carrier 10 comprises a release valve configured to be manually opened or open when a third pressure threshold is met. In this example, the third pressure threshold is higher than the first and the second pressure thresholds. Thus, the system overshooting can be prevented. Alternatively, the release valve can be used as an emergency stop to rapidly expel the fluid within the container carrier to the ambient, thus, the medicament delivery operation can be stopped.

[0098] In another example, instead of connecting the fluid pressure power source to the container carrier directly, the container carrier may comprise a flexible bag adjacent to both the first medicament container and the second medicament container. In this example, the flexible bag comprises a fluid inlet configured to be connected to a fluid pressure power source such that fluid from the fluid pressure power source can flow into the flexible bag and increase pressure within the first body and the second body respectively until the first pressure threshold and the second pressure threshold are met. In this example, the container carrier doesn’t need to be fluid-tight, instead, the flexible bag is fluid-tight. In a preferred example, a sub-assembly of the medicament delivery device can be provided. The sub-assembly comprises the container assembly according to any one of the above-mentioned examples, and a pneumatic pump operably connected to the container carrier 10. The pneumatic pump is configured to increase the pressure within the first and the second body of the medicament container to expel the first and the second fluid. Thus, the medicament delivery sequence between the first fluid and the second fluid can be determined by the output gas of the pneumatic pump.

[0099] In a preferred example, the container assembly is configured to be connected to a reusable fluid pressure power source of the medicament delivery device. As shown in Figs 4A-4B, the fluid pressure power source 2 is attached to the container assembly. In this example, the container carrier 10 an interior space to receive the first and the second medicament containers 11 , 12. Preferably the container carrier 10 comprises a frame 14 where the first and the second medicament container 12, 12 can be attached to. In a preferred example, the first and the second conveying members and / or the medicament delivery member are connected to the first and the second medicament container respectively via the frame 14. Furthermore, the container carrier 10 comprises a cover 15 configured to seal the interior space of the container carrier 10. Alternatively, the container carrier can be a cassette configured to be received at least partially by a reusable body of the medicament delivery device comprising the fluid pressure power source. In a preferred example, the medicament delivery device is portable. In one example, the container carrier 10 comprises a wearable feature 16, e.g., a strap or a belt, configured to be worn by the user. Alternatively, the reusable body of the medicament delivery device comprises the wearable feature configured to be worn by the user.

Claims

CLAIMS1. A container assembly of a medicament delivery device, the container assembly comprising: a container carrier accommodating a first medicament container and a second medicament container; wherein the first medicament container comprises a first body configured to accommodate a first fluid and a first exit where the first fluid can be expelled from the first exit; wherein the first medicament container comprises a first valve assembly positioned between the first body and the first exit; wherein the first valve assembly is configured to establish a fluid communication between the first body and the first exit when fluid pressure within the first body meets a first pressure threshold; wherein the second medicament container comprises a second body configured to accommodate a second fluid and a second exit where the second fluid can be expelled from the second exit; wherein the second medicament container comprises a second valve assembly positioned between the second body and the second exit; wherein the second valve assembly is configured to establish a fluid communication between the second body and the second exit when fluid pressure within the second body meets second pressure threshold; and wherein the first pressure threshold is lower than the second pressure threshold.

2. The container assembly according to claim 1 , wherein the first valve assembly comprises a first one-way valve; and wherein the second valve assembly comprises a second one-way valve.

3. The container assembly according to claim 2, wherein the first one-way valve has a first cracking pressure value; wherein the second one-way valve has a second cracking pressure valve; and wherein the first cracking pressure value is lower than the second cracking pressure value.

4. The container assembly according to claim 2, wherein viscosity of the first fluid is lower than the second fluid; and wherein the first one-way valve and the second one-way valve have the same cracking pressure.

5. The container assembly according to claim 1 or 2, wherein at least one of the first valve assembly and the second valve assembly comprises a flow conditioner; wherein the flow conditioner is configured to increase or decrease the fluidic resistance between the first and / or second body and the first and / or second exit.

6. The container assembly according to any one of the preceding claims, wherein the first body of the first medicament container is a flexible bag; and wherein the second body of the second medicament container is a flexible bag.

7. The container assembly according to claim 6, wherein the container carrier comprises a fluid inlet configured to be connected to a fluid pressure power source such that fluid from the fluid pressure power source can flow into the container carrier and increase pressure within the first body and the second body respectively until the first pressure threshold and the second pressure threshold are met.

8. The container assembly according to claim 7, wherein the first body of the first medicament container comprises an inlet; wherein the second exit of the second medicament container is connected to the inlet of the first body; and wherein the first exit is configured to be connected to a medicament delivery member.

9. The container assembly according to claim 7, wherein the first exit is configured to be connected to a first conveying member; and wherein the second exit is configured to be connected to a second conveying member.

10. The container assembly according to claim 9, wherein the first conveying member and the second conveying member are connected to a medicament delivery member.

11. The container assembly according to claim 9 or 10, wherein the first conveying member is a first delivery tube; and wherein the second conveying member is a second delivery tube.

12. The container assembly according to claim 8 or 10, wherein the medicament delivery member is an injection needle or a soft cannula.

13. The container assembly according to any one of the preceding claims, wherein the container carrier comprises a release valve configured to be manually opened or open when a third pressure threshold is met; and wherein the third pressure threshold is higher than the first and the second pressure thresholds.

14. The container assembly according to any one of the preceding claims, wherein the container carrier comprises a flexible bag adjacent to both the first medicament container and the second medicament container; wherein the flexible bag comprises a fluid inlet configured to be connected to a fluid pressure power source such that fluid from the fluid pressure power source can flow into the flexible bag and increase pressure within the first body and the second body respectively until the first pressure threshold and the second pressure threshold are met.

15. A sub-assembly of the medicament delivery device, the sub-assembly comprising: the container assembly according to any one of claims 6-13; and a pneumatic pump operably connected to the container carrier; wherein the pneumatic pump is configured to increase pressure within the first body and the second body respectively until the first pressure threshold and the second pressure threshold are met.

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