Cannula assembly for drug delivery system

Abstract

A cannula assembly for a drug delivery system, wherein the cannula assembly is for fluid connection between an infusion container and an infusion tube, the cannula assembly comprising: a housing extending between a container end configured to be operably attached to an infusion container and a tube end configured to be operably attached along a longitudinal axis to an infusion tube; a cannula hub at least partially movably disposed within the housing; and a cannula comprising a cannula body, the cannula body comprising a tube section configured to be operably attached to an infusion tube and a container section configured to be operably attached to an infusion container, the container section of the cannula body being attached to the cannula hub, and the cannula hub being movable in the longitudinal direction relative to the housing between an initial position in which the container section of the cannula body of the cannula is fully received within the housing and a connected position in which the cannula body of the cannula is positioned at least partially outside the container end of the housing.

Description

Technical Field

[0001] The present disclosure generally relates to a cannula assembly for fluidly connecting an infusion container and an infusion tube, and more particularly to a cannula assembly comprising a housing and a cannula hub movable relative to the housing.

Background Art

[0002] Typically, the administration of high-volume and / or high-viscosity drugs is performed in a medical facility, such as a hospital, and the patient is assisted by a medical professional. For example, the administration of a high-volume drug can be performed by intravenous injection. In this case, the medical professional takes the infusion bag to the patient, hangs the infusion bag, connects a cannula between the infusion bag and the infusion tube to create a fluid connection between the drug and the infusion tube, places an infusion needle on the patient's body, and then connects the infusion tube to the injection needle.

[0003] Today, many drug delivery devices, such as automatic syringes or infusion pumps, can be designed for patients without formal medical training to self-administer drugs, so patients do not need to visit medical facilities frequently. Therefore, multiple automatic functions are desirable to avoid any potential handling errors.

[0004] To administer high-volume and / or high-viscosity drugs, or multiple different drugs, the user may need to perform more steps to execute the self-administration of the drug. For example, high-volume and / or high-viscosity drugs are generally stored separately from the drug delivery member to avoid any potential contamination and leakage. Therefore, there is another step of creating a fluid connection between the drug and the drug delivery member.

[0005] Therefore, it is desirable to simplify the steps of the user, for example, both the patient and the caregiver, in order to simplify the step of establishing a fluid connection between the drug container and the drug delivery member.

Summary of the Invention

[0006] The present invention is defined by the appended claims, which should be referred to below.

[0007] Therefore, a cannula assembly for a drug delivery system, the cannula assembly is for fluid connection between an infusion container and an infusion tube, and the cannula assembly is - A housing extending between a container end configured to be operably attached to an infusion container and a tube end configured to be operably attached to an infusion tube along its longitudinal axis, - A cannula hub that is movable at least partially within the housing, - A cannula comprising a cannula body, wherein the cannula body has a tube section configured to be operably attached to an infusion tube, and a container section configured to be operably attached to an infusion container, The container section of the cannula body is attached to the cannula hub. A cannula assembly is provided, comprising a cannula whose cannula hub is movable in the longitudinal direction relative to the housing between an initial position in which the container section of the cannula body of the cannula is fully received within the housing and a connected position in which the cannula body of the cannula is positioned at least partially outside the container end of the housing.

[0008] Cannula assemblies are suitable for use in drug delivery systems configured to deliver high volume, and / or high viscosity, and / or multiple drugs. Cannula assemblies are configured to create a fluid connection between the infusion container and the infusion tube only when it is necessary to cause movement of the cannula hub, for example, when the patient is expected to receive the drug.

[0009] Preferably, according to one embodiment, the container section of the cannula body has a sharp end for opening the seal of the infusion container. On the other hand, the tube section does not need to be sharp, as it is configured only to connect to the infusion tube and not to puncture the patient's skin or seal.

[0010] Preferably, according to another embodiment, the cannula hub comprises a fluid channel coaxial with the cannula body, and the tubular section of the cannula body is fully received within the cannula hub.

[0011] Preferably, according to another embodiment, the cannula hub comprises a protruding section that extends from the housing, thereby configuring the cannula hub to be manually moved from an initial position to a connection position by the user moving the protruding section relative to the housing.

[0012] Since there are no components necessary to generate the movement of the cannula hub, the cost of the cannula assembly can be reduced.

[0013] Preferably, according to another embodiment, the protruding section of the cannula hub is positioned through a slot that extends longitudinally through the wall of the housing.

[0014] Alternatively, according to another embodiment, the cannula assembly is - A biasing member extending in the longitudinal direction between the surface of the housing and the surface of the cannula hub, thereby biasing the cannula hub toward the connection position by the biasing member, - A cannula block including a surface facing the opposite end of the housing, The cannula hub includes opposing surfaces directed toward the end of the housing, and the cannula hub block is immovable in the longitudinal direction relative to the housing. In the locked position, the surface of the cannula block engages with the opposing surface of the cannula hub, thereby preventing the cannula hub from being biased to the connection position. In the released position, it disengages from the opposing surface of the cannula hub, thereby biasing the cannula hub to the connection position by the biasing member.

[0015] In this embodiment, the movement of the cannula hub is generated by a biasing member, thereby allowing the cannula to be connected more precisely to the infusion container.

[0016] Preferably, according to another embodiment, the cannula assembly includes a lock holder having a body that is movable relative to the housing between a first position and a second position.

[0017] Preferably, according to another embodiment, the cannula block is operably connected to the lock holder when the lock holder is in a first position, and is not connected to the lock holder when the lock holder is in a second position.

[0018] Preferably, according to another embodiment, the body of the lock holder comprises an inner section positioned within the housing and an outer section positioned outside the housing.

[0019] Preferably, according to another embodiment, the body of the lock holder is movable laterally with respect to the housing with respect to the longitudinal axis between a first position and a second position.

[0020] Alternatively, according to another embodiment, the body of the lock holder is movable in the longitudinal direction relative to the housing between a first position and a second position.

[0021] Preferably, according to another embodiment, the biasing member is a spring.

[0022] Alternatively, according to another embodiment, the biasing member is an elastic arm.

[0023] Preferably, according to another embodiment, the surface of the cannula hub block is movable laterally with respect to the longitudinal axis from a locked position to an unlocked position.

[0024] Preferably, according to another embodiment, the surface of the cannula hub block is radially flexible from a locked position to an unlocked position with respect to the longitudinal axis.

[0025] Preferably, according to another embodiment, the cannula hub block includes a flexible arm extending from the housing, and the flexible arm includes a ledge having the surface of the cannula hub block.

[0026] Preferably, according to another embodiment, the lock holder is an outer sleeve movable axially with respect to the housing between a first position where the outer sleeve is circumferentially adjacent to the flexible arm and a second position where the outer sleeve is circumferentially offset from the flexible arm.

[0027] Preferably, according to another embodiment, the outer section of the lock holder extends in the direction of the container end of the housing and axially beyond the container end of the housing, such that when the container end of the housing is attached to the infusion container, the outer sleeve is moved from the first position to the second position by the infusion container.

[0028] Alternatively, according to another embodiment, the cannula hub block includes a clip having a clip body surrounding the cannula hub.

[0029] Preferably, according to another embodiment, the clip body includes a ledge having the surface of the cannula hub block.

[0030] Preferably, according to another embodiment, the clip body is circumferentially expandable with respect to the longitudinal axis, such that when the clip body expands circumferentially outward from the longitudinal axis, the surface of the cannula hub block is moved from a locked position to an unlocked position.

[0031] Preferably, according to another embodiment, the lock holder is movable relative to the clip from a first position in which the inner section of the body of the lock holder is coupled to the clip, thereby preventing the expansion of the clip body, to a second position in which the inner section of the body of the lock holder is detached from the clip, thereby allowing the expansion of the clip body.

[0032] Preferably, according to another embodiment, when the inner section of the body of the lock holder is coupled to the clip, the inner section of the body engages with the clip body, and when the inner section of the body is disengaged from the clip, the inner section of the body of the lock holder disengages from the clip body.

[0033] Preferably, according to another embodiment, when the inner section of the body of the lock holder is coupled to the clip, the inner section of the body engages with the clip body, and when the inner section of the body is disengaged from the clip, the inner section of the body of the lock holder disengages from the clip body.

[0034] Alternatively, according to another embodiment, the cannula block comprises two expansions extending laterally with respect to a longitudinal axis, the two expansions being configured to be separated from each other, and the clip body extending circumferentially around the longitudinal axis from one of the two expansions to the other of the two expansions, the inner section of the body engaging with the two expansions when the inner section of the body is coupled to the clip, and disengaging from the expansions when the inner section of the body is disengaged from the clip.

[0035] Alternatively, according to another embodiment, the lock holder is an integral part of the cannula block.

[0036] Preferably, according to another embodiment, the outer section of the body of the lock holder is a user-accessible button, which allows the user of the cannula assembly to manually move the lock holder from the locked position to the released position.

[0037] Preferably, according to another embodiment, the cannula block is configured to be manually moved by the user from a locked position to a released position.

[0038] Alternatively, according to another embodiment, the outer section of the body of the lock holder is operably connected to the power supply of the drug delivery device.

[0039] Preferably, according to another embodiment, the cannula block is configured to move from a locked position to an released position by the power supply of the drug delivery device.

[0040] Preferably, according to another embodiment, the outer section of the body of the lock holder is configured to be positioned within an airtight chamber, so that the lock holder moves due to changes in air pressure within the airtight chamber, moving the cannula block from the locked position to the released position.

[0041] Preferably, according to another embodiment, the housing includes a container fastener configured to be operably attached to an infusion container.

[0042] Preferably, according to another embodiment, the container fastener is located near the container end of the housing.

[0043] Preferably, according to another embodiment, the container fastener is at least one of a thread, a bayonet connector, and a snap-fit ​​connector.

[0044] Preferably, according to another embodiment, the container section of the cannula is sealed by a sheath.

[0045] Alternatively or additionally, according to another embodiment, the container end of the housing is sealed with a membrane.

[0046] Preferably, according to another embodiment, the housing includes a hub fastener.

[0047] Preferably, according to another embodiment, the cannula hub includes a counter fastener that is attached to a hub fastener of the housing when the cannula hub is in the connection position.

[0048] Preferably, according to another embodiment, the housing hub fastener and the cannula hub counter fastener are configured to form a snap-fit ​​attachment when the cannula hub is in the connection position.

[0049] Preferably, according to another embodiment, the cannula assembly is configured for use in a drug delivery system comprising an infusion container, an infusion tube, a drug delivery member, and a cannula assembly.

[0050] Preferably, according to another embodiment, the drug delivery system comprises a drug delivery device having a power source for automatically releasing a drug contained in an infusion container, an infusion tube, and a drug delivery member.

[0051] Preferably, the power source for the drug delivery device may be a motor-driven gear set, a peristaltic pump, a magnet-based pressure pump, a spring, or a fluid pressure power source.

[0052] Preferably, according to another embodiment, the drug delivery device comprises a reusable body equipped with a fluid pressure power source, a container carrier, and an infusion container having a body equipped with a fluid outlet. The body includes a flexible portion. The infusion container is at least partially placed within the container carrier. The container carrier comprises a fluid-sealed chamber. The fluid-sealed chamber includes an inlet. The inlet is configured to be fluidly connected to the outlet of the fluid pressure power source of the reusable body of the drug delivery device. The fluid-sealed chamber is coupled to the flexible portion of the body of the infusion container, so that when the inlet receives output fluid from the fluid pressure power source, the output fluid flows into the fluid-sealed chamber, and the drug contained in the infusion container is pushed out under the pressure of the output fluid. The fluid outlet is configured to be connected to a cannula assembly, as disclosed above, so that the drug can be delivered to a drug delivery site through the fluid outlet of the drug delivery device, the cannula assembly, the infusion tube, and the drug delivery member.

[0053] Preferably, according to another embodiment, the drug delivery device comprises a cassette detachably attached to a reusable body.

[0054] Preferably, according to another embodiment, the cassette includes a container carrier.

[0055] Preferably, according to another embodiment, the cassette comprises a cassette housing.

[0056] Preferably, according to another embodiment, the cassette housing is configured to be attached to a reusable body of the drug delivery device.

[0057] Preferably, according to another embodiment, the container carrier is located inside the cassette housing.

[0058] Preferably, according to another embodiment, the body of the infusion container comprises a flexible bag.

[0059] 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 infusion container, thereby increasing the gas pressure around the fluid-sealed chamber and releasing the drug contained in the infusion container. The hydraulic power source is configured to output liquid to the infusion container, thereby increasing the liquid pressure around the fluid-sealed chamber and releasing the drug contained in the infusion container. When the fluid pressure power source is a pneumatic power source, the fluid-sealed chamber is airtight. When the fluid pressure power source is a hydraulic power source, the fluid-sealed chamber may be either airtight or liquid-tight.

[0060] Accordingly, a drug delivery device comprising an infusion container as disclosed herein can provide a drive system for a pneumatic or hydraulic drug delivery device that can deliver one or more drugs in a desired order and at a desired drug delivery flow rate, respectively. The system does not require prior knowledge of the volume and / or viscosity of each drug. Thus, the reusable body of the drug delivery device can be used for different drugs contained in different disposable cassettes. The infusion container can be filled with drugs by a pharmacy ("filled at use") or by a pharmaceutical company ("pre-filled"). For example, in a hospital or in the compounding room of an infusion center, or by a pharmaceutical company ("pre-filled"). During use, air can be added to the inside of the cassette at a known mass flow rate to crush the flexible container inside the cassette and deliver its contents to the patient at a known, controllable volume flow rate.

[0061] Preferably, according to another embodiment, the fluid-sealed chamber is a second flexible bag that completely encloses the infusion container. This can be achieved by a multilayer bag assembly in which one port is the fluid outlet of the fluid-sealed chamber and the other port is the inlet of the fluid-sealed chamber.

[0062] Preferably, according to another embodiment, the infusion tube is equipped with a tube valve.

[0063] Preferably, according to another embodiment, the tube valve is an in-line valve included in the infusion tube.

[0064] Preferably, according to another embodiment, the tube valve of the infusion tube is a one-way valve so as not to allow fluid to flow through the infusion tube toward the infusion container.

[0065] Preferably, according to another embodiment, the tube valve of the infusion tube is an umbrella valve, a Belleville valve, a ball valve, or a pinch valve.

[0066] Preferably, according to another embodiment, the body of the infusion container is housed in at least partially within a fluid-sealed chamber.

[0067] Preferably, according to another embodiment, the inlet of the fluid-sealed chamber is the outlet of the fluid-sealed chamber.

[0068] Preferably, according to another embodiment, the container carrier comprises a container chamber configured to accommodate at least partially an infusion container.

[0069] Preferably, according to another embodiment, the fluid-seal chamber is inflatable. The fluid-seal chamber is adjacent to the main body and is configured such that output fluid from a fluid pressure power source flows into the fluid-seal chamber, inflating the fluid-seal chamber and pressing against the infusion container.

[0070] Preferably, according to another embodiment, the inlet of the fluid-sealing chamber is equipped with a valve.

[0071] Preferably, according to another embodiment, the valve at the inlet of the fluid-sealed chamber is a one-way valve, and the fluid is allowed to pass through the one-way valve only in order to enter the fluid-sealed chamber.

[0072] Preferably, according to another embodiment, the drug delivery device comprises at least two infusion containers.

[0073] Preferably, according to another embodiment, the drug delivery device comprises at least two container carriers.

[0074] Preferably, according to another embodiment, at least two container carriers each contain at least two infusion containers.

[0075] Preferably, according to another embodiment, the cassette comprises at least two infusion containers.

[0076] Preferably, according to another embodiment, the cassette comprises at least two container carriers.

[0077] Preferably, according to another embodiment, the drug delivery device comprises one container carrier, the container carrier comprises at least two fluid-sealed chambers.

[0078] Preferably, according to another embodiment, at least two fluid-sealed chamber container carriers each house at least two infusion containers.

[0079] Preferably, according to another embodiment, the cassette comprises one container carrier, and the container carrier comprises at least two fluid-sealed chambers.

[0080] Preferably, according to another embodiment, each infusion container is provided with a fluid-separated connection to the patient so that separate medications do not mix during administration unless desired by the patient.

[0081] Preferably, according to another embodiment, a one-way valve is positioned between at least two fluid-sealing chambers.

[0082] Preferably, according to another embodiment, the one-way valve positioned between at least two fluid-sealing chambers is a disposable valve, such as a fragile valve.

[0083] Preferably, according to another embodiment, only one fluid-sealed chamber of at least two container carriers is provided with an inlet configured to be fluidly connected to a fluid pressure power source.

[0084] Preferably, according to another embodiment, a one-way valve between two fluid-sealed chambers is configured to open when a first fluid pressure threshold is reached. A valve at the inlet of a fluid-sealed chamber, configured to be fluidly connected to a fluid pressure power source, is configured to open when a second fluid pressure threshold is reached. The first fluid pressure threshold is greater than or equal to the second fluid pressure threshold.

[0085] Preferably, according to another embodiment, the fluid-sealed chamber includes a discharge valve configured to discharge the fluid flowing inside the fluid-sealed chamber from the fluid-sealed chamber to the outside.

[0086] Preferably, according to another embodiment, the release valve is configured to release the fluid flowing from the fluid pressure power source and accumulating in the fluid sealing chamber from the fluid sealing chamber to the environment surrounding the drug delivery device or to a receiving container contained in the drug delivery device when the fluid pressure reaches a predetermined threshold.

[0087] Preferably, according to another embodiment, the release valve is connected to an emergency button. The release valve is configured to release the fluid flowing in the fluid-sealed chamber from the fluid-sealed chamber into the environment around the drug delivery device or the receiving container contained in the drug delivery device when the emergency button is activated, and thus to stop the force that would cause the drug contained in the container to move.

[0088] Preferably, according to another embodiment, the emergency button can be pushed, pulled, slid, or twisted against the container carrier or reusable body of the drug delivery device in order to activate the emergency button.

[0089] Preferably, according to another embodiment, a valve at the inlet of a fluid-sealed chamber, configured to be fluidly connected to a fluid pressure power source, is configured to open when a second fluid pressure threshold is reached. A predetermined threshold is greater than the second fluid pressure threshold.

[0090] Preferably, according to another embodiment, a predetermined threshold is greater than a first fluid pressure threshold.

[0091] Preferably, according to another embodiment, the fluid-sealing chamber of the container carrier is made of a material that is at least partially rigid.

[0092] Preferably, according to another embodiment, the fluid-sealed chamber includes a pressure sensor.

[0093] Preferably, according to another embodiment, the container carrier includes a position sensor configured to detect the position of the infusion container.

[0094] Preferably, according to another embodiment, the infusion container position sensor is configured to monitor the pressure level in the fluid-sealed chamber by monitoring the position of the infusion container.

[0095] Preferably, according to another embodiment, the drug delivery device is portable.

[0096] Preferably, according to another embodiment, the drug delivery device is attached to the body over or under clothing.

[0097] Preferably, according to another embodiment, the drug delivery device is an injection device, such as an infusion device or an on-body syringe.

[0098] Preferably, according to another embodiment, the drug delivery device is configured to administer intravenous, subcutaneous, or intramuscular injections.

[0099] Preferably, according to another embodiment, the drug delivery member is an injection needle or insertion needle having a flexible cannula.

[0100] Preferably, according to another embodiment, the drug delivery device comprises a reusable body, a replaceable cannula assembly, and a replaceable drug delivery member.

[0101] Preferably, according to another embodiment, the reusable body of the drug delivery device comprises a fluid pressure power source connected to the inlet of a fluid-sealed chamber of a container carrier. The fluid outlet is operably connected to a drug delivery member.

[0102] Preferably, according to another embodiment, the drug delivery device comprises a processor electrically connected to a fluid pressure power source and a power supply connected to the processor. The processor and power supply are housed in a reusable body.

[0103] Preferably, according to another embodiment, the fluid-sealed chamber is adjacent to a fluid pressure power source. The fluid pressure power source is directly fluid-connected to the inlet of the fluid-sealed chamber.

[0104] Preferably, according to another embodiment, the transmission tube is located between the fluid pressure power source and the inlet of the fluid-sealed chamber. The fluid pressure power source is fluidly connected to the inlet of the fluid-sealed chamber via the transmission tube.

[0105] Preferably, according to another embodiment, the drug delivery device includes a user interface attached to a reusable body.

[0106] Preferably, according to another embodiment, the user interface is electrically connected to the processor.

[0107] Preferably, according to another embodiment, the user interface is a button protruding from the outer surface of a reusable body.

[0108] Preferably, according to another embodiment, the user interface is a screen or touch panel located on the outer surface of a reusable body.

[0109] Preferably, according to another embodiment, the drug delivery device comprises a wireless communication receiver connected to a processor.

[0110] Preferably, according to another embodiment, the drug delivery device comprises a wireless communication transmitter connected to a processor.

[0111] Preferably, according to another embodiment, the wireless communication receiver is configured to receive wireless signals from a remote device or information tag.

[0112] Preferably, according to another embodiment, the wireless communication transmitter is configured to transmit a wireless signal to a remote device or information tag.

[0113] Preferably, according to another embodiment, the pressure sensor and / or position sensor of the piston of the fluid-sealed measuring chamber, and / or the position sensor of the container carrier, are electrically connected to the processor.

[0114] Preferably, according to another embodiment, the processor is configured to control a fluid pressure power source to output fluid into the fluid sealing chamber in accordance with signals from a pressure sensor and / or position sensor of the piston of the fluid sealing measuring chamber and / or a position sensor of the container carrier.

[0115] Furthermore, if the drug delivery component is an injection needle or an insertion needle with a soft cannula, the system can also detect needle withdrawal when a pressure drop is detected within the fluid-sealed chamber.

[0116] Preferably, according to another embodiment, the intentional break point can be located near the end of the needle. For example, if the infusion tube is pulled in a manner that would normally remove the needle from the patient's skin, the tube may instead break at this joint, separating the infusion tube from the end of the needle.

[0117] This rupture has the effect of eliminating the pressure drop associated with back pressure between the needle and subcutaneous tissue. Therefore, for drugs delivered at a controlled flow rate, the upstream driving pressure is reduced.

[0118] A drive system capable of continuously monitoring the pressure and / or flow rate of the drug exiting the power source container can detect such sudden changes in flow, indicating that the infusion tube has separated from the needle at the end and presenting an error condition to stop the injection.

[0119] Preferably, according to another embodiment, a fluid pressure power source is connected to the fluid-sealed chambers of two container carriers, and a processor is configured to control the fluid pressure power source to selectively output fluid to at least one of the fluid-sealed chambers.

[0120] Preferably, according to another embodiment, the processor is configured to control a fluid pressure power source in accordance with signals from a pressure sensor and / or position sensor of the piston of a fluid-sealed measuring chamber, and / or a position sensor of the container carrier, to selectively output fluid into at least one of the fluid-sealed chambers.

[0121] Preferably, according to another embodiment, the processor is configured to control a fluid pressure power source to output a specific amount of fluid. This specific amount is predetermined or depends on signals from pressure and / or position sensors of the piston of the fluid-seal measuring chamber, and / or position sensors of the container carrier. This ensures that only that specific amount of drug contained in the infusion container is pushed out from the fluid outlet.

[0122] Preferably, according to another embodiment, the fluid pressure power source comprises a piezoelectric pump configured to output fluid from the fluid pressure power source. It is also preferable to use a piezoelectric pump as the pressure power source. Using a piezoelectric pump may be advantageous because it can provide quiet or silent operation and lower power operation compared to motor-driven solutions.

[0123] Preferably, according to another embodiment, the fluid pressure power source comprises a motor-based fluid pump configured to output fluid from the fluid pressure power source.

[0124] Preferably, according to another embodiment, the fluid pressure power source comprises a pressurized fluid canister configured to output fluid from the fluid pressure power source.

[0125] Preferably, according to another embodiment, if the fluid pressure power source is a barometric pressure power source, the barometric pressure power source includes a pressurized gas canister.

[0126] Preferably, according to another embodiment, when the fluid pressure power source is a pneumatic power source, the pneumatic power source is a well-controlled diaphragm pump when lower cost or complexity is desired.

[0127] Preferably, according to another embodiment, when the fluid pressure power source is a barometric power source, the barometric power source includes an electronic engine, such as a MEMS engine, and a liquid substance. In this example, the engine is configured to produce a propulsion gas by causing an electrochemical reaction of the liquid substance.

[0128] Preferably, according to another embodiment, the fluid pressure power source is a pressure power source. In this embodiment, the fluid output from the fluid pressure power source is a gas, such as air or nitrogen.

[0129] Preferably, according to another embodiment, the fluid pressure power source is a hydraulic power source. In this embodiment, the fluid output from the fluid pressure power source is a liquid, such as water or oil.

[0130] Preferably, according to another embodiment, the cannula assembly includes a perforated cap membrane that is tightly connected to the tip of the cannula before the soft membrane sealing the container end of the housing is punctured, and which forms a cap around the tip of the cannula.

[0131] Preferably, according to another embodiment, the cannula has a rounded tip and a side opening.

[0132] Preferably, according to another embodiment, the perforable cap membrane is a compressible membrane that covers the cannula before the soft membrane sealing the container end of the housing is punctured, creating a sterile barrier around the cannula.

[0133] Preferably, according to another embodiment, the bag port is provided with a cap, which is punctured axially, but some residual material needs to be punctured by a cannula in order to access the inside of the drug bag.

[0134] Preferably, according to another embodiment, the cannula assembly includes a cap which is punctured axially, but some residual material must be punctured by the cannula in order to access the inside of the drug bag, and the cap is initially tightly attached to the cannula.

[0135] The drug delivery devices described herein can be used to treat and / or prevent one or more of many different types of disorders. Exemplary disorders include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary drug types that may be included in the drug 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, peptide bodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, chimeric antigen receptor T-cell therapy, cell or gene therapy, oncolytic viruses, or immunotherapies and / or protein derivatives.Examples of drugs that may be included in the drug delivery devices described herein include etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine), alirocumab (rheumatoid arthritis), methotrexate (ametopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), and interferon β-1a (multiple cystitis). (Chemorrhagic disease), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), pegylated interferon β-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel disease) Diseases (e.g., Crohn's disease and ulcerative colitis), ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, semiprimab, rituximab, trastuzumab, ad-trastuzumab emtansine, fam-trastuzumab deruxtecan-NXKI, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, verantamab mahodotin-BLMF, bevacizumab, blinatumomab, brentuximab vedotin Examples of drugs include, but are not limited to, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafacitamab, or margetuximab (examples in parentheses are non-limiting examples of associated disorders). Pharmaceutical formulations containing, but not limited to, any of the drugs described herein, for example, pharmaceutical formulations containing the drugs listed herein (or pharmaceutically acceptable salts thereof) and pharmaceutically acceptable carriers are also intended for use in drug delivery devices described herein.A pharmaceutical preparation containing any of the drugs listed herein (or a pharmaceutically acceptable salt thereof) may contain one or more other active ingredients, or it may contain only one active ingredient.

[0136] Examples of drugs that may be included in the drug delivery devices described herein include, but are not limited to, immuno-oncological or bio-oncological agents such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.

[0137] Exemplary drugs that may be included in the drug delivery devices described herein include 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, and TIM-3 modulators. Examples of proposed mechanisms of action include, but are not limited to, 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 adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 OX40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapy, or TCR therapy.

[0138] Exemplary drugs that may be included in the drug delivery devices described herein include AC, high-dose 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, high-dose 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, and CALGB. Examples of multidrug therapy regimens include, but are not limited to, 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.

[0139] Examples of drugs that may be included in the drug delivery devices described herein include, but are not limited to, alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids used in chemotherapy. Examples of exemplary chemotherapy drugs include, but are not limited to, 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, barrubicin, vincristine, vinblastine, or vinorelbine.

[0140] Furthermore, all terms used in the claims should be interpreted according to their ordinary meanings in the art unless otherwise explicitly defined herein. All references to “a / an / the element, apparatus, component, means, etc.” should be interpreted broadly as referring to at least one example of an element, apparatus, component, means, etc. unless otherwise explicitly stated. [Brief explanation of the drawing]

[0141] Here, an embodiment of the concept of the present invention will be described as merely an example with reference to the accompanying drawings. [Figure 1] A schematic diagram of a drug delivery device comprising the cannula assembly of the present invention is shown. [Figure 2] A schematic diagram of an infusion container configured for use with the cannula assembly of the present invention is shown. [Figure 3] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 4] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 5] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 6] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 7] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 8] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 9] Schematic perspective and cross-sectional views of the cannula assembly of the present invention in different examples are shown. [Figure 10] Figure 1 schematically shows a reusable body of the drug delivery device having multiple cannula assemblies according to the present invention. [Modes for carrying out the invention]

[0142] Drug delivery systems for delivering high-volume / high-viscosity drugs typically comprise an infusion container and an infusion tube. The infusion tube is configured to be attached to the drug delivery component, for example, to an injection needle or soft cannula that is implanted in the patient's body.

[0143] Furthermore, the drug delivery system preferably includes a drug delivery device having a power source for automatically releasing the drug contained in the infusion container, an infusion tube, and a drug delivery member. Since most high-volume / high-viscosity drug deliveries take a long time to complete the drug delivery operation, most drug delivery devices are designed with wearable features so that the patient does not need to hold the drug delivery device for extended periods.

[0144] Figures 1 to 10 illustrate several examples of the cannula assembly of the present invention and drug delivery devices that can be used with these examples of the cannula assembly of the present invention. In particular, Figure 1 shows one example of a drug delivery device 2 that can be used with the cannula assembly of the present invention. The drug delivery device 2 comprises a reusable body 21 configured to fit into an infusion container 22, an infusion tube 3 operably connected to the infusion container 22 and a drug delivery member assembly 23 having a drug delivery member 4, and a wearable feature 25, such as a stripe, belt, or garment, extending from the reusable body and configured to be worn by the patient. Furthermore, the drug delivery device also comprises a power source 24 configured to output force to the infusion container to release the drug contained in the infusion container 22 from the drug delivery member 4. The power source 24 is configured to deliver force over a long period of time, for example, several hours or several days. For example, the power source 24 may be a motor, a fluid pressure power source, such as a gas pump or a hydraulic pump, or a peristaltic pump.

[0145] The cannula assembly of the present invention is configured to be fluidly connected between an infusion container and an infusion tube, thereby enabling the delivery of a drug contained in the infusion container 22 to the infusion tube 3 for delivery to the patient. The fluid connection between the cannula assembly, the infusion container 22, and the infusion tube 3 is configured to be established when the patient is scheduled to begin the drug delivery operation, thereby allowing the infusion container 22 to remain sterile until the patient wishes to receive the contained drug.

[0146] Figure 2 shows an example of an infusion container 22. The infusion container 22 comprises a body 220 with a fluid outlet 221. The body 220 is configured to contain a drug. The drug contained within the body 220 is configured to move out of the body 220 through the fluid outlet 221. The body 220 includes a flexible portion. In a preferred example, the body 220 comprises a flexible bag 220. The infusion container 22 comprises connectors 222, 223 attached to the body 220 and adjacent to the fluid outlet 221. The connectors 222, 223 extend from the connectors away from the body 220 of the infusion container 22 and include fasteners 222 configured to operably connect to the infusion tube 3. A fluid channel 221a is provided in the body of the connectors 222, 223 and is aligned with the fluid outlet 221. The port 223 of the fluid channel 221a and / or connectors 222, 223 may be sealed with a membrane and / or arranged with a one-way valve depending on the storage requirements of the contained drug.

[0147] As shown in Figures 3 to 9, the cannula assembly of the present invention comprises a housing 1 extending between a container end X configured to be operably attached to an infusion container 22 and a tube end Y configured to be operably attached to an infusion tube 3 along a longitudinal axis L; a cannula hub 6 at least partially movably disposed within the housing 1; and a cannula 5 comprising a cannula body 50, the cannula 5 having a tube section configured to be operably attached to an infusion tube 3 and a container section configured to be operably attached to an infusion container 22. In one example, the cannula hub is fully positioned within the housing and movable relative to the housing 1. In this example, the risk of the user accidentally moving the cannula hub can be reduced. Alternatively, the cannula hub is partially positioned within the housing and movable relative to the housing.

[0148] The container section of the cannula body 50 is attached to the cannula hub 6. In one example, both the tube section and the container section of the cannula body 50 are attached to the cannula hub 6, as shown in Figure 3. Alternatively, only the container section of the cannula body is attached to the cannula hub. The cannula hub 6 is movable in the longitudinal axis L direction relative to the housing 1 between an initial position in which the container section of the cannula body 50 of the cannula 5 is fully received within the housing 1, as shown in Figures 3 and 8, and a connected position in which the cannula body 50 of the cannula 5 is positioned at least partially outside the container end X of the housing 1, as shown in Figures 5, 7, and 9.

[0149] The container section of the cannula body 50 has a sharp end for opening the seal of the infusion container 22. On the other hand, the tube section does not need to be sharp, as it is configured only to connect to the infusion tube 3 and not to puncture the patient's skin or seal.

[0150] As shown in Figure 3, the cannula hub 6 has a fluid channel coaxial with the cannula body 50, and the tubular section of the cannula body 50 is fully received within the cannula hub 6.

[0151] As shown in Figure 3, when the cannula assembly is attached to the infusion container, the container end X of the housing 1 is adjacent to the infusion container, and as a result, the cannula 5 is positioned outside the container end X of the housing 1, at which point a fluid connection is established between the infusion container 22 and the cannula 5. Preferably, when the cannula assembly is attached to the infusion container 22 and the cannula hub 6 is in the connection position, the cannula 5 fits snugly into the fluid channel 221a.

[0152] In a preferred example, the cannula 5 has a sharp end on the container section. The sharp end of the cannula 5 is configured to face the fluid channel 221a of the infusion container, so that the cannula 5 can puncture the membrane before a fluid connection is established between the cannula body 50 and the infusion container 22, if the fluid channel 221a is sealed by a membrane. Furthermore, in a preferred example, the container section of the cannula is sealed by a sheath. Alternatively, as shown in Figure 3, the container end of the housing is sealed by a membrane 9.

[0153] The container end of the cannula assembly housing is configured to be attached to the infusion container, for example, by being glued or taped. In one example where the connectors 222, 223 of the infusion container 22 have fasteners 222, the housing 1 includes a container fastener 13 configured to be operably attached to the infusion container 22. The container fastener 13 is located near the container end X of the housing 1. The container fastener 13 is configured to be attached to the fasteners 222 of the connectors 222, 223 of the infusion container 22. In a preferred example, the container fastener 13 is at least one of a thread, a bayonet connector, and a snap-fit ​​connector. For example, as shown in Figure 4, the container fastener 13 is a snap-fit ​​arm extending in the longitudinal direction L from the container end X of the housing 1, so that the patient and / or caregiver, such as a nurse or pharmacist, can easily attach the cannula assembly to the infusion container 22.

[0154] In a preferred example, the housing 1 includes a hub fastener 1a, and the cannula hub 6 includes a counter fastener 61 configured to attach to the hub fastener 1a of the housing 1 when the cannula hub 6 is in the connection position, thereby immobilizing the cannula 5 relative to the infusion container 22 during drug delivery. In a preferred example, the hub fastener 1a of the housing 1 and the counter fastener 61 of the cannula hub 6 are configured to form a snap-fit ​​attachment when the cannula hub 6 is in the connection position. For example, the counter fastener 61 of the cannula hub 6 includes a snap-fit ​​arm 61 with a hook at its free end, the snap-fit ​​arm extending laterally from the wall 60 of the cannula hub 6 with respect to the longitudinal axis L. In this example, the hub fastener 1a of the housing 1 is a recess / notch in the wall of the housing 1.

[0155] Furthermore, in one example, the housing 1 includes an outer shell 10 configured to surround the cannula hub 6. In one example, the outer shell 10 includes a tube connector 101 extending from a portion of the cannula hub 6 in which the tube section of the cannula 5 is located.

[0156] The tube connector 101 is configured to be attached to the infusion tube 3. In one example, the infusion tube can be attached to the outer shell 10 of the housing 1 of the cannula assembly before being delivered to the patient and / or caregiver. Alternatively, the infusion tube 3 and the infusion container 22 can be delivered separately. The patient and / or caregiver will receive the infusion tube 3, the cannula assembly, and the infusion container 22 as three separate components and will need to connect the infusion tube 3 to the cannula assembly. Alternatively, the infusion tube 3 and the cannula assembly can be pre-assembled together before being delivered to the patient and / or caregiver.

[0157] Since the cannula hub 6 and the cannula 5 are attached to each other, when the cannula hub 6 is in the connection position, the cannula hub 6 can move the cannula 5 into the fluid channel 221a. In one example, the patient and / or caregiver can manually move the cannula hub from the initial position to the connection position. In a preferred example, the cannula hub has a protruding section that extends from the housing, so that the cannula hub is configured to be manually moved from the initial position to the connection position by the user moving the protruding section relative to the housing. For example, the protruding section of the cannula hub is positioned through a slot that extends longitudinally in the wall of the housing. In a preferred example, the protruding section of the cannula hub extends laterally with respect to the longitudinal axis L so as to move away from the housing.

[0158] Alternatively, the cannula hub can be automatically moved from its initial position to the connection position when the patient and / or caregiver initiates the drug delivery operation or intentionally causes a connection between the cannula and the infusion container. This example avoids manual connection errors. In this example, the cannula assembly includes a biasing member 8 extending in the longitudinal direction L between the surface of the housing and the surface of the cannula hub 6, thereby biasing the cannula hub toward the connection position by the biasing member 8. In one example where the housing 1 includes an outer shell 10, as shown in Figures 3, 5, and 7-9, the biasing member 8 extends between the surface of the outer shell 10 facing the container end X of the housing 1 and the surface of the cannula hub facing the opposite side of the container end X of the housing 1. In a preferred example, the biasing member 8 is a spring, such as a compression spring, tension spring, or torsion spring.

[0159] The cannula assembly further comprises a cannula hub 110;110' including surfaces 110a;110a' facing opposite the container end X of the housing 1. The cannula hub 6 has a facing surface 60a directed toward the container end X of the housing 1. The cannula hub 110;110' is immovable relative to the housing 1 in the longitudinal axis L direction. In one example, the cannula hub is an integral part of the housing. Alternatively, the cannula hub is attached to the housing via a threaded connection, a bayonet connection, or a snap-fit ​​connection. Alternatively, a ledge extends longitudinally from the wall of the housing, and the cannula hub is located on the ledge. Alternatively, a recess / notch is located in the wall of the housing, and the cannula hub is located within the recess / notch of the housing.

[0160] The surfaces 110a;110a' of the cannula hub block 110;110' engage with the opposing surface 60a of the cannula hub 6 in the locked position, as shown in Figures 3 and 8, thereby preventing the cannula hub 6 from being biased to the connection position. In the released position, as shown in Figures 5, 7, and 9, the surfaces 110a;110a' engage with the opposing surface of the cannula hub, thereby biasing the cannula hub 6 to the connection position by the biasing member 8.

[0161] In a preferred example, the surfaces 110a;110a' of the cannula block 110;110' are movable laterally with respect to the longitudinal axis L from a locked position to a released position.

[0162] Preferably, the cannula assembly includes a lock holder 7;7';7'' having a body movable relative to the housing 1. The body of the lock holder 7;7';7'' comprises an inner section 70;70' positioned within the housing 1 and an outer section 71;71';71'' positioned outside the housing 1. The cannula block 110;110' is operably connected to the lock holder 7;7';7''.

[0163] In another preferred example, the surface 110a;110a' of the cannula block 110;110' is radially flexible with respect to the longitudinal axis L from a locked position to a released position. In one example, the cannula block 110 includes a flexible arm 11 extending from the housing 1. The flexible arm 11 includes a ledge having the surface 110a of the cannula block 110. In one example, the lock holder 7 is configured to move in the longitudinal axis L direction relative to the housing 1. In one example, the lock holder 7 is an outer sleeve 7 which is movable in the longitudinal axis L direction relative to the housing 1 between a first position in which the outer sleeve 7 is circumferentially adjacent to the flexible arm 11 and a second position in which the outer sleeve 7 is circumferentially offset from the flexible arm 11, as shown in Figures 3 and 4. In a preferred example, the outer component 71 of the body of the lock holder 7 is a projection 71 extending beyond the container end X of the housing 1. As shown in Figure 4, in one example where the housing 1 is equipped with a container fastener 13, the projection 71 extends beyond the container fastener 13. As a result, when the container end X of the housing 1 is attached to the infusion container 22, the infusion container 22 pushes the outer sleeve 7 aside via the projection 71. Thus, the outer sleeve 7 moves from a first position to a second position relative to the housing 1 along the longitudinal axis L, thereby allowing the flexible arm 11 to flex radially outward. In one example where the projection 71 extends beyond the container fastener 13 of the housing 1, when the container fastener 13 of the housing 1 is attached to the fastener 222 of the infusion container 22, the projection 71 moves relative to the housing 1, pushed by a portion of the fastener 222 of the infusion container 22, as shown in Figure 4. In one example, the interface formed between the surface 110a of the cannula hub block 110 and the opposing surface 60a of the cannula hub 6 is a chamfered surface, so that when the outer sleeve 7 is in the second position, the flexible arm 11 bends radially outward through the opposing surface 60a of the cannula hub 6 by the biasing member 8. Alternatively or additionally, when the outer sleeve is in the first position, the flexible arm is pre-tensioned inward with respect to the longitudinal axis L.

[0164] When the flexible arm 11 bends radially outward, the surface 110a of the cannula hub block 110 is disengaged from the opposing surface 60a of the cannula hub 6 (the cannula hub block 110 moves to the release position), and therefore, as shown in Figure 5, the cannula hub 6 is biased to the connection position by the biasing member 8. In a preferred example, when the cannula hub 6 moves to the connection position, the counter fastener 61 of the cannula hub 6 snaps into the hub fastener 1a of the housing 1.

[0165] In this example, a fluid connection between the cannula assembly and the infusion container 22 is established when the patient and / or caregiver attaches the cannula assembly to the infusion container 22. For example, the cannula assembly can be delivered to the patient as a separate component, or it can be housed within a reusable body 21' of the drug delivery device, as shown in Figure 10. In a preferred example, the cannula assembly is detachably housed within the reusable body 21'. For example, the cannula assembly can be immovably attached to connectors 222, 223 of the infusion container 22, or alternatively, the container fasteners of the housing are configured to immovably attach to the container. As a result, the cannula assembly can be removed together with the infusion container 22 to separate from the reusable body 21' after use.

[0166] Alternatively, the surface of the cannula block can move linearly laterally with respect to the longitudinal axis L between the locked and released positions. Alternatively, the surface of the cannula block can pivot with respect to the longitudinal axis L from the locked position to the released position.

[0167] Alternatively, in another example, the cannula hub block 110' comprises a clip having a clip body 110b' surrounding the cannula hub 5. The clip body 110b' comprises a ledge having a surface 110a' of the cannula hub block 110'. The clip body 110b' is expandable circumferentially with respect to the longitudinal axis L, so that when the clip body 110b' expands circumferentially outward from the longitudinal axis L, the surface 110a' of the cannula hub block 110' moves from a locked position to a released position. Similar to the above example, the clip body can be configured to engage with / disengage from an outer sleeve, so that axial movement of the outer sleeve allows the cannula hub block to move to a released position. Similar to the example described above, the interface formed between the surface 110a' of the clip body 110b' and the opposing surface of the cannula hub 6 is a chamfered surface, so that when the outer sleeve is disengaged from the clip body, the clip body is expanded outward by the biasing member 8 via the opposing surface of the cannula hub 6. Alternatively or additionally, when the outer sleeve is in the first position, the clip body is pre-tensioned inward with respect to the longitudinal axis L.

[0168] Alternatively, in another example, the lock holder 7';7'' of the cannula assembly is configured to move laterally with respect to the longitudinal axis L. In one example where the cannula block 110 has a flexible arm 11 as described above, the inner section of the lock holder is configured to surround the flexible arm 11, so that the cannula block cannot move to the released position until the inner section of the lock holder moves laterally with respect to the longitudinal axis L via the outer section 71' of the body, thereby separating it from the flexible arm of the cannula block.

[0169] In one example where the cannula block 110' includes a clip, the lock holder 7';7'' is movable relative to the clip from a first position where the inner section 70' of the body of the lock holder 7' is coupled to the clip, thereby preventing expansion of the clip body 110b', to a second position where the inner section 70' of the body of the lock holder is discoupled from the clip, thereby allowing expansion of the clip body 110b'. For example, when the inner section of the body of the lock holder is coupled to the clip, the inner section of the body engages with the clip body. When the inner section of the body is discoupled from the clip, the inner section of the body lock holder is discoupled from the clip body. Alternatively or additionally, the cannula block 110;110' includes two expansions extending laterally with respect to a longitudinal axis L. These two expansions are configured to be spaced apart from each other. The clip body 110b' extends circumferentially around the longitudinal axis from one of the two expansions to the other of the two expansions. When the inner section of the body is coupled to the clip, the inner section 70' of the body of the lock holder 7';7'' engages with the two expansions, thereby pushing the two expansions toward each other. When the inner section 70' of the body of the lock holder 7' is released from the clip, the inner section 70' of the body of the lock holder 7' is released from the expansions. For example, as shown in Figures 6-7, the notch 70a' is located in the wall of the inner section 70' of the body of the lock holder 7';7''. As a result, the wall of the inner section 70' is engaged with the expansions of the clip until the lock holder 7' moves laterally relative to the clip with respect to the longitudinal axis L, so that the notch aligns with the expansions, and thus the clip body 110b' can expand circumferentially, allowing the expansions to move into the notch. Therefore, the clip body 110b' cannot expand to the release position, and thus the cannula block moves to the release position.

[0170] In one example, as shown in Figures 6-7, the outer section 71' of the body of the lock holder 7' is a user-accessible button, which allows the user of the cannula assembly to manually move the lock holder 7' from the locked position to the released position. For example, when the infusion tube 3 is connected and the patient is ready to receive medication, the patient and / or caregiver can press the button to establish a fluid connection between the infusion container 22 and the cannula 5.

[0171] Alternatively, the outer section 71'' of the body of the lock holder 7'' is operably connected to a drug delivery device, so that the movement of the lock holder 7'' is initiated by the mechanism of the drug delivery device. In a preferred example, the outer section 71'' of the body of the lock holder is operably connected to a power source 24 of the drug delivery device. In one example, the outer section 71'' of the body of the lock holder 7'' is configured to be positioned within an airtight chamber 241, so that, as shown in Figures 9-10, changes in atmospheric pressure within the airtight chamber 241 move the lock holder 7'', moving the cannula block 110' from the locked position to the released position. In this shown example, the inner section of the body of the lock holder 7'' and the clip of the cannula block 110' are the same as in the previous example. Preferably, the outer section 71'' of the body of the lock holder 7'' is a pin that is airtightly positioned within a channel that is fluidly connected to the airtight chamber 241. In this example, the drug delivery device comprises a pneumatic operating mechanism connected to an airtight chamber 241. In a preferred example, the drug delivery device comprises a pneumatic power source 24, such as a gas pump, with a gas outlet 242 connected to the airtight chamber 241. In one example, the gas pump is configured to create a vacuum inside the airtight chamber 241, which pulls the outer section 71' of the body of the lock holder 7'', moving the lock holder 7'' to a second position. Alternatively, the gas pump can deliver gas to the airtight chamber, resulting in the lock holder 7'' being pushed to the second position. In this example, as shown in Figure 10, the cannula assembly is not visible primarily to the user, e.g., the patient and / or caregiver. For example, the reusable body 21' of the drug delivery device 2 is configured to receive multiple infusion containers. In this example, the reusable body 21' of the drug delivery device 2 comprises a functional section for receiving the power source and cannula assembly, and a drug section 210' for receiving the infusion containers.For example, the drug section 210' can be covered by a lid 211', the user can open the lid 211', and the infusion containers can be attached to the cannula assembly via fasteners 222 on each infusion container 22 and container fasteners 13 on each cannula assembly.

[0172] In this example, the drug delivery device includes a control interface 26, such as a touch panel or buttons, to control the establishment of a fluid connection between each infusion container and each cannula.

[0173] For example, a patient may need to take different medications in a specific order. In this example, the infusion tubing comprises branches, each connected to a housing of a cannula assembly. The power source 24 is configured to initiate a fluid connection between a particular cannula and a particular infusion container when ready to deliver the medication contained in that particular infusion container. In one example where the infusion container is a flexible bag and the power source of the drug delivery device is a pneumatic power source, the drug delivery device can be operated to control the sequence of drug delivery by controlling the sequence of establishing a fluid connection between the cannula assembly and the infusion container. For example, the drug delivery device may comprise three infusion containers, each containing three different medications A, B, and C, and the patient is prescribed to be treated in the following steps in the following order: 1. Take medication A. 2. Take medication B. 3. Stop taking any medication for 15 minutes. 4. Finally, take medication C.

[0174] In this example, the pneumatic power source 24 of the drug delivery device can be operated in the following steps in the following order. 1. The outer section 71'' of the body of the lock holder 7' located within the cannula assembly connected to the infusion container containing drug A is moved, thereby moving the cannula lock 110' to the release position and the cannula hub 6 to the connection position, thus establishing a fluid connection between the cannula assembly connected to the infusion container containing drug A. 2. Deliver gas into the drug section of the reusable device to release drug A to the patient until drug A has been completely delivered. 3. Establish a fluid connection between the cannula assembly connected to the infusion container containing drug B, using the method defined in Step 1. 4. Dispense drug B to the patient using the method defined in Step 2. 5. Count down for 15 minutes. 6. Establish a fluid connection between the cannula assembly connected to the infusion container containing drug C, using the method defined in step 1. 7. Dispense drug C to the patient using the method defined in Step 2.

[0175] Alternatively, the infusion containers are positioned within multiple airtight chambers, allowing for independent control of the drug delivery rate for each medication.

[0176] Alternatively, the drug delivery device comprises only one infusion container, and in this example, the power source of the drug delivery device is configured to initiate the fluid connection between one cannula assembly and one infusion container.

[0177] To maintain the sterile barrier of the cannula 5 after sterilization, the cannula 5 can be sealed within a chamber. In Figure 3, such a chamber is separated on one side by a soft membrane 9. The membrane 9 is a flexible, rubbery membrane that can be punctured by the cannula 5. The chamber is separated on the other side by a housing 1 and a needle hub 6. This requires an airtight connection, i.e., a sealed interface, between the needle hub 6 and the housing 1.

[0178] The design can be simplified by reducing the sealed interface, as shown in Figures 11B and 11C. Figure 11A shows the cannula 5 not enclosed within a sterile chamber. One end of the cannula 5 is connected to the infusion tube 3. At the opposite end, the tip 51 of the cannula 5 faces a soft membrane 9 attached to the bag port 223. Figure B shows a modified embodiment in which a pierceable cap membrane 90 is tightly connected to the tip 51 of the cannula 5, forming a cap around the tip 51 of the cannula 5, before the soft membrane 9 is punctured. The pierceable cap membrane 90 is a soft, flexible, rubbery membrane that can be punctured. During the puncture motion, the pierceable cap membrane 90 comes into contact with the soft membrane 9, then the tip 51 of the cannula 5 punctures the soft membrane 9 following the pierceable cap membrane 90, and the pierceable cap membrane 90 is pushed toward the infusion tube 3. Figure 11C shows the configuration at the end of the puncture movement.

[0179] The embodiments in Figures 11B and 11C can be modified by using a cannula 5 with a rounded tip 51 and a side opening 52, as shown in Figures 12A to 12D. This design adds a resealable function similar to a valve to the cannula 5. Figure 12A shows the configuration before puncture occurs. Figure 12B shows the configuration when the perforated cap membrane 90 is in contact with the soft membrane 9. Figure 12C shows the configuration after the tip 51 of the cannula 5 has punctured the perforated cap membrane 90 and then the soft membrane 9. Figure 12D shows the configuration when the cannula 5 is retracted, i.e., returned from the drug bag. In this embodiment, the cannula can be retracted and sealed within the soft membrane 9.

[0180] The embodiment shown in Figure 11A can be modified by using a compressible membrane 91, as shown in Figure 13A. The compressible membrane 91 is a soft, flexible, rubbery membrane that can be punctured and compressed. The compressible membrane 91 covers the cannula 5 before use to create a sterile barrier around it. As shown in Figure 13B, during the puncture motion, the tip 51 of the cannula 5 punctures the soft membrane 9, which compresses the compressible membrane 91.

[0181] Embodiments in Figures 11A to 13B show a design having a soft, rubbery membrane 9 for re-penetrating and / or sealing the cannula 5. The membrane 9 can be assembled to the bag port 223 during injection molding by press-fit, welding, bonding, or overmolding.

[0182] However, as shown in Figure 14A, the bag port 223 may be equipped with a cap 92 instead of a membrane 9. The cap 92 is punctured axially, but this puncture does not penetrate to the inside of the drug bag, and some residual material 93 must be punctured by the cannula 5 to access the inside of the drug bag. Figure 14A shows the initial configuration, Figure 14B shows the configuration just before the cannula punctures the residual material 93, and Figure 14C shows the configuration at the end of the puncture movement.

[0183] In an alternative embodiment, the cap 92 is a separate element, not part of the bag port 223. As shown in Figure 15A, the cap 92 is first fitted onto the cannula 5. During the puncture movement, the cap 92 comes into contact with the bag port 223 (as shown in Figure 15B), the cannula 5 then punctures the residual material 93, and the cap 92 is pushed toward the infusion tube 3. Figure 15C shows the configuration at the end of the puncture movement. In this embodiment, the bag port 223 includes a guide portion 94 configured to guide the cannula 5 once it has punctured the residual material 93 and penetrated into the bag.

[0184] The concept of the present invention has been explained primarily by reference to several examples. However, as will be readily apparent to those skilled in the art, other embodiments not disclosed above are equally possible within the scope of the concept of the present invention as defined by the appended claims.

[0185] Several other embodiments of the present invention are defined in the following clauses. 1. A cannula assembly for a drug delivery system, wherein the cannula assembly is for fluid connection between an infusion container and an infusion tube, and the cannula assembly is - A housing extending between a container end configured to be operably attached to an infusion container and a tube end configured to be operably attached to an infusion tube along its longitudinal axis, - A cannula hub that is movable at least partially within the housing, - A cannula comprising a cannula body, wherein the cannula body has a tube section configured to be operably attached to an infusion tube, and a container section configured to be operably attached to an infusion container, The container section of the cannula body is attached to the cannula hub. A cannula assembly comprising a cannula, the cannula hub being movable in the longitudinal direction relative to the housing between an initial position in which the container section of the cannula body of the cannula is fully received within the housing and a connected position in which the cannula body of the cannula is positioned at least partially outside the container end of the housing. 2. The cannula assembly described in Clause 1, wherein the cannula hub comprises a protruding section that protrudes from the housing, thereby configuring the cannula hub to be manually moved from an initial position to a connection position by the user moving the protruding section relative to the housing. 3. The cannula assembly described in Clause 2, wherein the protruding section of the cannula hub is positioned through a slot that extends longitudinally through the wall of the housing. 4. - A biasing member extending in the longitudinal direction between the surface of the housing and the surface of the cannula hub, thereby biasing the cannula hub toward the connection position by the biasing member, - A cannula block including a surface facing the opposite end of the housing, The cannula hub includes opposing surfaces directed toward the end of the housing, and the cannula hub block is immovable in the longitudinal direction relative to the housing. The cannula assembly according to Clause 1, wherein the surface of the cannula block engages with the opposing surface of the cannula hub in the locked position, thereby preventing the cannula hub from being biased to the connection position, and disengages from the opposing surface of the cannula hub in the released position, thereby biasing the cannula hub to the connection position by the biasing member. 5. The cannula assembly according to Clause 4, comprising a lock holder having a body movable relative to a housing between a first position and a second position, wherein the body of the lock holder comprises an inner section positioned within the housing and an outer section positioned outside the housing, and the cannula block is operably connected to the lock holder when the lock holder is in the first position and not connected to the lock holder when the lock holder is in the second position. 6. A cannula assembly according to clause 4 or 5, wherein the biasing member is a spring. 7. The cannula assembly according to clauses 4-6, wherein the surface of the cannula block is movable laterally with respect to the longitudinal axis from the locked position to the released position. 8. The cannula assembly according to Clause 7, wherein the surface of the cannula block is radially flexible with respect to the longitudinal axis from the locked position to the released position. 9. The cannula assembly according to Clause 8, as subject to Clause 5, wherein the cannula block comprises a flexible arm extending from the housing, the flexible arm comprising a ledge having the surface of the cannula block, and the lock holder comprising an outer sleeve, the outer sleeve being movable in the longitudinal direction relative to the housing between a first position in which the outer sleeve is circumferentially adjacent to the flexible arm and a second position in which the outer sleeve is circumferentially offset from the flexible arm. 10. The cannula assembly according to Clause 9, wherein the outer section of the lock holder extends toward the container end of the housing and extends longitudinally beyond the container end of the housing, so that when the container end of the housing is attached to the infusion container, the outer sleeve is moved by the infusion container from a first position to a second position. 11. The cannula assembly according to any one of clauses 4 to 8, wherein the cannula hub block comprises a clip having a clip body surrounding a cannula hub, the clip body having a ledge having the surface of the cannula hub block, and the clip body is expandable circumferentially with respect to a longitudinal axis L, so that when the clip body expands circumferentially outward from the longitudinal axis, the surface of the cannula hub block moves from a locked position to a released position. 12. The cannula assembly described in Clause 11, as subject to Clause 5, wherein the lock holder is movable relative to the clip from a first position in which the inner section of the body of the lock holder is coupled to the clip, thereby preventing the expansion of the clip body, to a second position in which the inner section of the body of the lock holder is released from the clip, thereby allowing the expansion of the clip body. 13. The cannula assembly described in Clause 12, wherein when the inner section of the body of the lock holder is coupled to the clip, the inner section of the body engages with the clip body, and when the inner section of the body is disengaged from the clip, the inner section of the body of the lock holder disengages from the clip body. 14. The cannula assembly according to Clause 12, comprising a cannula block having two expansions extending laterally with respect to a longitudinal axis, the two expansions being configured to be separated from each other, and a clip body extending circumferentially around the longitudinal axis from one of the two expansions to the other of the two expansions, the inner section of the body engaging with the two expansions when the inner section of the body is coupled to the clip, and disengaging from the expansions when the inner section of the body is disengaged from the clip. 15. The cannula assembly described in any one of Clauses 5 to 14, wherein the outer section of the body of the lock holder is a user-accessible button, thereby allowing the user of the cannula assembly to manually move the lock holder from the locked position to the released position. 16. The cannula assembly according to any one of Clauses 5 to 14, wherein the outer section of the body of the lock holder is configured to be positioned within an airtight chamber, so that a change in the air pressure within the airtight chamber moves the lock holder, thereby moving the cannula block from a locked position to a released position. 17. A cannula assembly according to any one of Clauses 1 to 16, wherein the housing comprises a container fastener configured to be operably attached to an infusion container, the container fastener being located near the container end of the housing, and the container fastener being at least one of a thread, a bayonet connector, and a snap-fit ​​connector. 18. A cannula assembly as described in any one of Clauses 1 to 17, wherein the container section of the cannula is sealed by a sheath. 19. A cannula assembly according to any one of clauses 1 to 18, wherein the container end of the housing is sealed by a membrane. 20. A cannula assembly according to any one of Clauses 1 to 19, wherein the housing comprises a hub fastener, and the cannula hub comprises a counter fastener that is attached to the hub fastener of the housing when the cannula hub is in the connection position. 21. The cannula assembly according to Clause 20, wherein the housing hub fastener and the cannula hub counter fastener are configured to form a snap-fit ​​attachment when the cannula hub is in the connection position. 22. A cannula assembly according to any one of Clauses 1 to 21, comprising a permeable cap membrane that is tightly connected to the tip of the cannula before a soft membrane sealing the container end of the housing is punctured, and which forms a cap around the tip of the cannula. 23. A cannula assembly according to any one of clauses 1 to 22, wherein the cannula has a rounded tip and a lateral opening. 24. The cannula assembly according to Clause 22 or 23, wherein the perforable cap membrane is a compressible membrane that covers the cannula before the soft membrane sealing the container end of the housing is punctured, creating a sterile barrier around the cannula. 25. A cannula assembly according to any one of Clauses 1 to 21, wherein the bag port is provided with a cap, which is punctured axially, but some residual material must be punctured by a cannula (5) to access the inside of the drug bag. 26. A cannula assembly according to any one of Clauses 1 to 21, wherein the cannula assembly comprises a cap, which is punctured axially, but some residual material must be punctured by the cannula in order to access the inside of the drug bag, and the cap is initially tightly attached to the cannula.

Claims

1. A cannula assembly for a drug delivery system, wherein the cannula assembly is for fluid connection between an infusion container (22) and an infusion tube (3), and the cannula assembly is - A housing (1) extending between a container end (X) configured to be operably attached to the infusion container (22) and a tube end (Y) configured to be operably attached to the infusion tube (3) along the vertical axis (L), - A cannula hub (6) is movably disposed at least partially within the housing (1), - A cannula (5) comprising a cannula body (50), wherein the cannula body (50) comprises a tube section configured to be operably attached to an infusion tube (3) and a container section configured to be operably attached to an infusion container (22), wherein the container section of the cannula body (50) is attached to a cannula hub (6), and the cannula hub (6) is movable in the longitudinal axis (L) direction relative to the housing (1) between an initial position in which the container section of the cannula body (50) of the cannula (5) is fully received within the housing (1) and a connected position in which the cannula body (50) of the cannula (5) is positioned at least partially outside the container end (X) of the housing (1), - A biasing member (8) extending in the longitudinal axis (L) direction between the surface of the housing (1) and the surface of the cannula hub (6), wherein the cannula hub (6) is biased toward the connection position by the biasing member (8), - A cannula block (110; 110') including a surface (110a; 110a') facing the opposite side of the container end (X) of the housing (1), The cannula hub (6) includes an opposing surface (60a) directed toward the container end (X) of the housing (1), and the cannula hub block (110; 110') is immovable relative to the housing (1) in the longitudinal axis (L) direction. A cannula assembly in which the surface (110a; 110a') of the cannula hub block (110; 110') engages with the opposing surface (60a) of the cannula hub (6) in the locked position, thereby preventing the cannula hub (6) from being biased to the connection position, and disengages from the opposing surface (60a) of the cannula hub (6) in the released position, thereby biasing the cannula hub (6) to the connection position by the biasing member (8).

2. The cannula assembly according to claim 1, comprising a lock holder (7;7';7'') having a body movable relative to the housing (1) between a first position and a second position, wherein the body of the lock holder (7;7';7'') comprises an inner section (70;70') positioned within the housing (1) and an outer section (71;71';71'') positioned outside the housing (1), and the cannula hub block (110;110') being operably connected to the lock holder (7;7';7'') when the lock holder is in the first position, and not connected to the lock holder (7;7';7'') when the lock holder is in the second position.

3. The cannula assembly according to claim 1 or 2, wherein the biasing member (8) is a spring.

4. The cannula assembly according to any one of claims 1 to 3, wherein the surface (110a; 110a') of the cannula block (110; 110') is movable laterally with respect to the longitudinal axis (L) from the locked position to the released position.

5. The cannula assembly according to claim 4, wherein the surface (110a; 110a') of the cannula block (110; 110') is radially flexible with respect to the longitudinal axis (L) from the locked position to the released position.

6. The cannula assembly according to claim 5, as dependent on claim 2, wherein the cannula block (110; 110') comprises a flexible arm (11) extending from the housing (1), the flexible arm (11) comprises a ledge having the surface (110a; 110a') of the cannula block (110; 110'), and the lock holder (7; 7'; 7'') is an outer sleeve (7) which is movable in the longitudinal axis (L) direction relative to the housing (1) between a first position where the outer sleeve (7) is circumferentially adjacent to the flexible arm (11) and a second position where the outer sleeve (7) is circumferentially offset from the flexible arm (11).

7. The cannula assembly according to claim 6, wherein the outer section (71; 71') of the lock holder (7; 7'; 7'') extends in the direction of the container end (X) of the housing (1) and extends beyond the container end (X) of the housing (1) in the longitudinal axis (L) direction, thereby causing the outer sleeve (7) to move from the first position to the second position by the infusion container (22) when the container end (X) of the housing (1) is attached to the infusion container (22).

8. The cannula assembly according to any one of claims 1 to 7, wherein the cannula hub block (110; 110') comprises a clip having a clip body (110b') surrounding the cannula hub (6), the clip body (110b') comprises a ledge having the surface (110a; 110a') of the cannula hub block (110; 110'), the clip body (110b') is expandable circumferentially with respect to the longitudinal axis (L), so that when the clip body (110b') expands circumferentially outward from the longitudinal axis (L), the surface (110a; 110a') of the cannula hub block (110; 110') moves from the locked position to the released position.

9. The cannula assembly according to claim 8, as dependent on claim 2, wherein the lock holder (7;7';7'') is movable relative to the clip from a first position in which the inner section of the body of the lock holder (7;7';7'') is coupled to the clip, thereby preventing the expansion of the clip body (110b'), to a second position in which the inner section of the body of the lock holder (7;7';7'') is released from the clip, thereby allowing the expansion of the clip body (110b').

10. The cannula assembly according to claim 9, wherein when the inner section of the body of the lock holder (7;7';7'') is coupled to the clip, the inner section of the body engages with the clip body (110b'), and when the inner section of the body is disengaged from the clip, the inner section of the body of the lock holder (7;7';7'') disengages from the clip body (110b').

11. The cannula assembly according to claim 9, wherein the cannula block (110; 110') comprises two extensions extending laterally with respect to the longitudinal axis (L), the two extensions being configured to be separated from each other, the clip body (110b') extending circumferentially around the longitudinal axis (L) from one of the two extensions to the other of the two extensions, the inner section of the body engaging with the two extensions when the inner section of the body is coupled to the clip, and the inner section of the body disengaging from the extensions when the inner section of the body is disengaged from the clip.

12. The cannula assembly according to any one of claims 2 to 11, wherein the outer section (71; 71'; 71'') of the body of the lock holder (7; 7'; 7'') is a user-accessible button, thereby allowing the user of the cannula assembly to manually move the lock holder to move the cannula hub block (110; 110') from the locked position to the released position.

13. The cannula assembly according to any one of claims 2 to 11, wherein the outer sections (71; 71'; 71'') of the body of the lock holder (7; 7'; 7'') are configured to be positioned within an airtight chamber (241), so that the lock holder is moved by a change in air pressure within the airtight chamber (241) to move the cannula block (110; 110') from the locked position to the released position.

14. The cannula assembly according to any one of claims 1 to 13, wherein the housing (1) comprises a container fastener (13) configured to be operably attached to the infusion container (22), the container fastener (13) is located near the container end (X) of the housing (1), and the container fastener (13) is at least one of a thread, a bayonet connector, and a snap-fit ​​connector.

15. The cannula assembly according to any one of claims 1 to 14, comprising a perforable cap membrane (90) that is tightly connected to the tip (51) of the cannula (5) before the soft membrane (9) sealing the container end (X) of the housing (1) is punctured, and which forms a cap around the tip (51) of the cannula (5).

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