Flow communication unit with unconnected configuration and connected configuration

Abstract

A flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) for establishing flow communication from a multi-use drug delivery device adapted for long-term use to a flow directing device, wherein the drug delivery device comprises a reservoir comprising a plurality of doses of a liquid drug formulation, wherein the reservoir is adapted for pressurizing the liquid drug formulation, wherein the flow directing device (230) is adapted for directing the drug to a subject's subcutaneous tissue, wherein the flow communication unit is adapted for being in an unconnected configuration and a connected configuration, whereby the flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) is adapted for enabling long-term use of the multi-use drug delivery device.

Description

Technical Field

[0001] This invention relates to a flow communication unit for establishing flow communication from a reusable drug delivery device suitable for long-term use to a flow guiding device, wherein the drug delivery device includes a pressurized reservoir comprising multiple doses of a drug formulation, and wherein the drug formulation allows for microbial growth after introduction into the reservoir during long-term use, and wherein the flow guiding device is adapted to guide the drug to the subcutaneous tissue of a subject. In another aspect, this invention relates to a flow communication unit for closing a container comprising multiple doses and allowing removal of the contents without removing or damaging the flow communication unit. In yet another aspect, this invention relates to a flow communication unit comprising unconnected and connected configurations. Background Technology

[0002] The disclosure of this invention mainly mentions the treatment of diabetes by delivering liquid insulin preparations; however, this is merely an exemplary use of the invention.

[0003] Drug delivery devices in the form of injection devices have greatly improved the lives of patients who must self-administer liquid medications and biologics. Drug delivery devices can take many forms, ranging from simple, single-use devices consisting merely of ampoules with an injection route, to highly complex electronically controlled instruments with numerous functions. Some devices are designed for single use and can be supplied with an integrated needle, such as a so-called pre-filled syringe. However, in cases where the drug delivery device is intended for multiple injections, it will typically be designed for use with a replaceable needle or cannula unit, ideally used to replace each injection of a given dose of medication. Regardless of their form, they have proven to be of great help in assisting patients with self-administration of injectable medications and biologics. They also greatly assist caregivers in administering injectable medications to those who are unable to self-inject.

[0004] In particular, pen-type injection devices have been shown to provide a precise, convenient, and often discrete way to administer drugs and biologics, such as insulin. While pen-type injection devices are typically cylindrical in shape with the needle protruding from the distal end of one end of the device, some devices have other shapes and the needle no longer protrudes from the distal end of one end of the device, such as the Innova® and InnoLet® from Novo Nordisk A / S (Bagsværd, Denmark).

[0005] Typically, injection devices use pre-filled cartridges containing the liquid medication of interest, such as 1.5 or 3.0 ml of insulin or growth hormone preparations. The cartridge is typically in the form of a generally cylindrical, transparent glass cylinder with a distal bottleneck portion having a distal opening closed by a needle-pierceable septum and an opposing proximal opening therein receiving an elastomeric piston arranged to be moved by the drug delivery mechanism of the injection device. Injection devices are generally of two types: "durable" devices and "disposable" devices. Durable devices are designed to allow the user to replace one cartridge with another, typically replacing an empty cartridge with a new one. In contrast, disposable devices feature a single, non-replaceable cartridge; once the cartridge is empty, the entire device is discarded.

[0006] As described above, drug delivery devices intended for multiple injections are typically designed for use in conjunction with a replaceable needle unit comprising a proximal needle portion adapted for insertion into a cartridge filled with medication through a needle-permeable diaphragm seal and a distal needle portion adapted for subcutaneous administration. This allows a given dose of liquid drug formulation to be subcutaneously injected through a hollow needle. Because the proximal needle portion penetrates the cannula's seal and provides a flow path from the inside to the outside of the cannula, it introduces a risk of contaminating the cartridge contents.

[0007] The drug delivery device may also be in the form of an infusion system, including: a pump having the aforementioned cartridge; and an infusion set that directs liquid medication from the cartridge's reservoir to the subject's infusion site.

[0008] The risk of contamination is primarily related to the removal of the needle unit or infusion set after use. Once the cannula penetrates the cartridge seal, it provides a pathway from the surrounding environment to the drug formulation and should therefore be removed immediately after injection. However, after injection but before needle removal, when the cannula is withdrawn from the subject's skin, a small amount of drug formulation within the needle itself may be contaminated by bodily fluids or bacteria from the surrounding environment. When the cannula is removed from the cartridge, some residual fluid from the cannula may be aspirated into the cartridge, thus contaminating the drug formulation within.

[0009] Therefore, pharmaceutical formulations used in multi-dose injection devices must contain sufficient levels of preservatives to ensure resistance to biostatic conditions of contamination during the intended use of the cartridge, i.e., conditions that inhibit microbial growth. This requirement is included in the current edition of the International Pharmacopoeia in the chapter on injectable pharmaceutical formulations.

[0010] Different national and international pharmacopoeias are published by officially recognized bodies and provide universal quality standards throughout the pharmaceutical industry. Product quality testing standards for parenteral drug products (including injectables) are part of the pharmacopoeias, and some of the requirements are described below. Parenteral drug products are administered via skin or other external boundary tissues to allow the direct application of the active pharmaceutical substance to blood vessels, organs, tissues, or lesions. Injectables can be available in dosage forms that provide immediate or prolonged release. Routes of administration for parenteral drug products include intravenous, intracardiac, intra-articular, intra-articular, intramuscular, intrathecal, intracisional, intraocular, and subcutaneous administration. Parenteral dosage forms include solutions, suspensions, emulsions, sterile powders of solutions and suspensions (including liposomes), and products consisting of a drug and a device (such as a drug-eluting stent).

[0011] Regulatory requirements for drug delivery devices stipulate that the packaging system must not physically or chemically interact with the formulation in a way that alters its strength, quality, or purity beyond official or established requirements. The packaging system should be closed or sealed in a manner that prevents contamination or loss of contents. Validation of container integrity must demonstrate the absence of microbial contamination or the gain or loss of any chemical or physical parameters necessary to protect the product.

[0012] The aforementioned drug delivery device is not merely a packaging system, as it also possesses the additional function of facilitating drug administration. Such a drug delivery device can be referred to as a dual-function container closure system.

[0013] According to pharmacopoeias, a dual-function container closure system is characterized by the addition of one or more intended functions to the container's functionality, requiring special consideration for integrity assessment. Typically, one compartment of a dual-container closure system, the container compartment, is designed to contain the drug or solution before use or activation. The other compartment, the delivery compartment, with a different function and design, can deliver the product directly from the system's product-containing compartment into a fluid pathway for direct injection into the patient, or communicate with another sterile pathway into the device. For example, a pre-filled syringe contains a solution (container compartment) and a device component (delivery compartment), which is physically separate from the container compartment and used to administer the drug directly to the patient.

[0014] Therefore, dual-container closure systems typically have at least two compartments requiring microbial barrier performance, and for both compartments, packaging integrity after sterilization and / or aseptic filling should be demonstrated. In many cases, different parts of a dual system require different integrity testing methods. The choice of integrity testing method depends primarily on the intended target or performance requirements of the specific compartment. For example, the solution or drug-containing container compartment of a dual-container closure system must be closed or sealed in a manner that prevents product leakage or microbial ingress during and after the manufacturing process. On the other hand, the delivery portion of a dual-container closure system (including the delivery compartment portion) typically includes a fluid path that is empty during sterilization or aseptic filling and is designed to remain dry until the product container portion is activated prior to use. Covers, sheaths, or possibly lids designed to ventilate during sterilization and storage protect the delivery compartment from airborne microbial ingress throughout the item's lifespan. However, this portion of the device is often not designed to prevent liquid ingress. Secondary packaging or the physical design of the system itself can prevent liquid ingress.

[0015] The closure for multi-dose containers allows for the removal of contents without removing or breaking the closure. The closure allows needle penetration and closes immediately after needle removal to prevent contamination of the container. Validation of the integrity of multi-dose containers must include verifying that such packaging prevents microbial contamination or loss of product contents under anticipated multiple entry and use conditions.

[0016] For example, for testing pre-filled syringes without an attached sterile needle, the test involves draining the contents and transferring them to a culture medium. Macroscopic evidence of microbial growth in the culture medium should be checked periodically during and at the end of the incubation period. If no signs of microbial growth are found, the product to be tested meets sterility requirements.

[0017] In multi-dose containers, liquid drugs are preserved with preservatives to prevent microbial growth during prolonged use (i.e., small doses administered over a long period in continuous delivery, or large doses administered over a long period). The use of preservatives may reduce drug efficacy in some cases and may be incompatible with drugs in others, meaning that this type of drug formulation cannot be used with multi-dose injection devices. For example, necessary preservatives may destroy the drug substance by precipitating it in the cartridge or by reacting chemically with it.

[0018] WO 2015 / 1770821 discloses a medical cartridge for multi-dose medical drugs that minimizes waste of the medical drug without the need for preservatives. The cartridge includes a one-way valve disposed within the interior 5 of the cartridge near the outlet end. The one-way valve is arranged to allow fluid to flow from the interior of the medical cartridge to the outlet end and to prevent fluid from flowing from the outlet end back into the interior of the medical cartridge. An injection needle can be mounted at the outlet end of the cartridge via a needle adapter and extends through a diaphragm at the outlet end of the cartridge. Distributing the one-way valve within the cartridge is advantageous because it allows for a design that minimizes the dead volume within the cartridge. By distributing the one-way valve within the cartridge, no additional or external interface is required between the outlet end of the cartridge and the one-way valve, thus eliminating or at least significantly reducing the risk of leakage at such an interface. Descriptions of different embodiments indicate that the one-way valve can replace the passive diaphragm of the medical cartridge. In this implementation scheme, the one-way valve is positioned inside the cartridge, immediately adjacent to the outlet, and in direct contact with the injection needle connected to the cartridge outlet. This design can further reduce the dead volume inside the cartridge, thereby further reducing the waste of medical supplies.

[0019] For such systems, it is important to prevent leakage during use and to limit impurities from entering the drug delivery device (e.g., through the direct contact interface between the valve and the injection needle). Summary of the Invention

[0020] In the disclosure of this invention, a number of embodiments and aspects will be described that will solve one or more of the above-described objectives, or objectives that will be apparent from the following disclosure and from the description of exemplary embodiments.

[0021] Therefore, in general aspects of the invention, a flow communication unit is provided for establishing flow communication from a reusable drug delivery device suitable for long-term use to a flow guiding device, wherein the drug delivery device includes a reservoir comprising multiple doses of a liquid drug formulation, wherein the reservoir is adapted to pressurize the liquid drug formulation, and wherein the flow guiding device is adapted to guide the drug to the subcutaneous tissue of a subject, wherein the flow communication unit includes: - An inlet surface for interfacing with a drug delivery device. - An outlet surface, the outlet surface being configured in: (i) a connected configuration, wherein the outlet surface allows the flow communication unit and the flow guiding device to be connected, and wherein the outlet surface is adapted to interface with the flow guiding device; (ii) a disconnected configuration, wherein the outlet surface allows the flow communication unit and the flow guiding device to be disconnected, and wherein the outlet surface is adapted to reduce the entry of contaminants into the interior space of the flow communication unit. - An intermediate surface extending between the inlet surface and the outlet surface, wherein the outlet surface is in either the connected configuration or the unconnected configuration, the inlet surface, the outlet surface, and the intermediate surface define an outer surface and limit the internal space of the flow communication unit. - An outlet sealing member, with respect to the outlet surface in the connection configuration, the outlet sealing member providing a portion of the outlet surface, wherein the outlet sealing member is adapted to contact the flow guiding device to establish a tight fluid channel seal; - A first flow channel, comprising: a channel inlet adapted to provide flow communication with the drug delivery device; and a channel outlet adapted to provide flow communication with the flow guiding device. - First outlet valve component - An outlet barrier, the outlet barrier including a second outlet valve member adapted to cooperate with a first outlet valve member, wherein the outlet barrier provides a portion of the outlet surface, and wherein the outlet barrier is configured to: (i) a closed configuration, wherein the outlet surface is in an unconnected configuration, wherein the second outlet valve member is adapted to cooperate with the first outlet valve member to provide an outlet barrier seal, and wherein the outlet barrier seal is adapted to reduce contaminants entering the first channel through the channel outlet, and (ii) A flow configuration, wherein the outlet surface is in the connection configuration, wherein the second outlet valve member is adapted to cooperate with the first outlet valve member to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a first threshold. The flow communication unit is also adapted to be in the following position: (i) an unconnected configuration that responds to disconnecting the flow communication unit from the flow guiding device, wherein the outlet surface is in the unconnected configuration and wherein the outlet barrier is in the closed configuration, and (ii) a connection configuration responsive to connecting the flow communication unit to the flow guiding device, wherein the outlet surface is in the connection configuration, wherein the outlet barrier is in the flow configuration, wherein the outlet sealing member is arranged to contact the flow guiding device to provide the channel seal downstream of the channel outlet of the first flow channel, thereby adapting to allow flow communication between the channel outlet and the flow guiding device, wherein the channel outlet is arranged at the outlet surface of the flow communication unit; and In response to the channel inlet being arranged in flow communication with the drug delivery device and the flow communication unit being connected to the flow guiding device, a combined flow channel can be provided between the drug delivery device, the first flow channel and the flow guiding device, wherein the channel seal is arranged downstream of the channel outlet; Therefore, the flow communication unit is adapted to enable long-term use of the reusable drug delivery device, and thus, the flow communication unit is adapted to inhibit the entry of microorganisms into the reusable drug delivery device during long-term use.

[0022] Therefore, a flow communication unit is provided that allows for the long-term use of preservative-free pharmaceutical formulations to the extent that microbial growth is inhibited; that is, the pharmaceutical formulation allows microbial growth after the introduction of microorganisms into the reservoir during long-term use. A multi-dose drug delivery device combined with the flow communication unit according to this disclosure will be able to be used long-term without damaging or removing the closure of the multi-dose drug delivery device.

[0023] On the other hand, the outlet barrier provides the channel outlet, thereby enabling the barrier to regulate the outflow from the drug delivery device and restrict contaminants from entering the first flow channel in both connected and unconnected configurations of the first channel.

[0024] On the other hand, the flow communication unit also includes a one-way valve arranged along the first channel and adapted to guide downstream flow and inhibit upstream flow toward the drug delivery device. Forced one-way flow helps reduce contaminants entering the first channel through the channel outlet and enables the one-way valve, as part of the flow communication unit, to provide a self-sufficient flow communication unit where one-way flow is ensured. The valve may be, for example, part of an outlet barrier, but it can be arranged in all locations along the first flow channel.

[0025] On the other hand, the flow communication unit also includes a proximal puncture needle that extends from the inlet surface in an extended configuration, wherein the proximal needle includes a proximal opening end that provides an inlet to the channel. Thus, the flow communication unit is adapted to puncture the septum and thereby establish flow communication with the multi-dose drug reservoir.

[0026] On the other hand, the flow communication unit also includes a proximal puncture needle actuator adapted to change the proximal puncture needle from a retracted configuration to an extended configuration in response to connecting the flow communication unit to the flow guiding device. This reduces the risk of needle injury and eliminates the need for the protective skirt of the flow communication unit.

[0027] On the other hand, the flow communication unit also includes a proximal valve member adapted to allow flow from the inlet toward the outlet and to prevent backflow.

[0028] On the other hand, the proximal valve member provides a portion of the inlet surface for interfacing with the drug delivery device.

[0029] On the other hand, the proximal valve member provides a portion of the intermediate surface extending between the inlet surface and the outlet surface.

[0030] On the other hand, the portion of the intermediate surface is flexible and provides a device sealing surface to seal the drug delivery device.

[0031] On the other hand, the proximal valve component provides the channel inlets 548, 648, 748, and 848.

[0032] On the other hand, the distal support member includes a distal end and a distal portion, the distal portion being adapted to support the outlet barrier, and wherein... - The distal support member further includes a barrier operating member adapted to cooperate with the outlet barrier to adjust the tightness of the outlet barrier seal. - The outlet barrier includes an actuator portion that provides the outlet sealing member and is movably disposed between a first position and a second position relative to the barrier operating member, and is adapted to be configured to be in: (i) An unconnected configuration, wherein the outlet barrier is in the closed configuration, wherein the closed configuration of the outlet barrier further includes the actuator portion in the first position relative to the barrier operating member, whereby the second outlet valve member is adapted to cooperate with the first outlet valve member to provide the outlet barrier seal, the outlet barrier seal being adapted to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a second threshold, wherein the second threshold defines the tightness of the outlet barrier seal in the unconnected configuration and is greater than the first threshold. (ii) A connection configuration wherein the outlet barrier is in the flow configuration, wherein the flow configuration of the outlet barrier further includes the actuator portion in a second position relative to the barrier operating member, whereby the second outlet valve member is adapted to cooperate with the first outlet valve member to provide the outlet barrier seal, the outlet barrier seal being adapted to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a first threshold, wherein the first threshold defines the tightness of the outlet barrier seal in the connection configuration.

[0033] On the other hand, the actuator portion is adapted to be manipulated from the first position to the second position by the flow guiding device when connected.

[0034] On the other hand, the flow communication unit is also adapted to be in the following position: (i) the unconnected structure, wherein the tightness of the barrier seal is defined by a second threshold, and (ii) the connection configuration, wherein the tightness of the barrier seal is defined by the first threshold.

[0035] In some embodiments and in another, the flow communication unit further includes a proximal support member, the proximal support member including a proximal end and a proximal portion, the proximal portion being adapted to support the proximal valve member.

[0036] On the other hand, the proximal support member is rigid, and the proximal portion of the proximal support member includes a surface portion defining a proximal valve seat adapted to provide a proximal seat sealing surface, wherein the proximal valve member includes a surface portion adapted to provide a proximal valve sealing surface, and wherein a proximal fluid tight seal can be provided between the proximal valve sealing surface and the proximal seat sealing surface.

[0037] On the other hand, the proximal support member is rigid and provides the proximal portion of the first channel.

[0038] On the other hand, the proximal portion of the first channel provided by the proximal support member extends from the proximal end of the proximal support member.

[0039] On the other hand, the proximal valve member includes a surface portion that provides a portion of the inlet surface for interfacing with the drug delivery device, and wherein the proximal valve member is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface.

[0040] On the other hand, the flow communication unit includes a normally closed configuration, wherein the proximal valve member is in the normal configuration, thereby providing a tight seal for the proximal fluid.

[0041] On the other hand, the proximal support member includes an enlarged channel portion adapted to receive a receiving portion of the proximal valve member, wherein the receiving portion of the proximal valve member includes the proximal valve sealing surface, wherein the flow communication unit includes an open configuration, wherein the enlarged channel portion receives the receiving portion of the proximal valve member in the forced configuration, and wherein no proximal fluid tight seal is provided.

[0042] On the other hand, the proximal support member also includes a support portion adapted to be supported by the drug delivery device, thereby providing support for the flow communication unit relative to the drug delivery device.

[0043] In some embodiments and in another, the flow communication unit includes an intermediate valve component.

[0044] On the other hand, the proximal support member includes a distal end and a distal portion, the distal portion being adapted to support the intermediate valve member.

[0045] On the other hand, the proximal support member is rigid, and the distal portion of the proximal support member includes a surface portion defining an intermediate valve seat adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal (597.8) is possible between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0046] On the other hand, the proximal portion of the first channel provided by the proximal support member extends from the proximal end to the distal end.

[0047] On the other hand, the intermediate valve member includes a proximal surface portion for interfacing with the proximal support member, and wherein the intermediate valve member is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0048] On the other hand, the normally closed configuration of the flow communication unit also includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid.

[0049] In some embodiments and in another, the flow communication unit includes a distal support member.

[0050] On the other hand, the distal support member is rigid and provides the distal portion of the first channel.

[0051] On the other hand, the distal support member includes an enlarged channel portion adapted to receive a portion of a flexible portion of the intermediate valve member, wherein the flexible portion of the intermediate valve member includes the intermediate valve sealing surface, and wherein the opening configuration of the flow communication unit further includes the enlarged channel portion receiving a portion of the flexible portion of the intermediate valve member in the forced configuration, wherein the intermediate fluid tight seal is not provided.

[0052] On the other hand, the distal support member also includes a support portion adapted to be supported by the proximal support member, thereby providing stability to the flow communication unit.

[0053] On the other hand, the distal support member and the proximal support member are adapted to clamp a portion of the intermediate valve member, and the clamped portion is thus fixed, while the unclamped portion is adapted to move between the normal configuration and the forced configuration.

[0054] On the other hand, the distal support member also includes a support portion adapted to be supported by the drug delivery device, thereby providing support for the flow communication unit relative to the drug delivery device.

[0055] In some embodiments and in another, the distal support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier.

[0056] On the other hand, the distal support member is rigid, and the distal portion of the distal support member includes a surface portion defining the first outlet valve member, the first outlet valve member being adapted to provide a seat sealing surface, and the outlet barrier includes a surface portion defining the second outlet valve member, which is adapted to provide a valve sealing surface, and wherein the outlet barrier seal is capable of being provided between the valve sealing surface and the valve seat sealing surface.

[0057] On the other hand, the outlet barrier includes a proximal surface portion for interfacing with the distal support member, and wherein the outlet barrier is flexible and can change from a normal configuration to a forced configuration in response to pressure in the first channel and on the proximal surface portion exceeding the first threshold.

[0058] On the other hand, the normally closed configuration of the flow communication unit also includes the outlet barrier being in the normal configuration and providing the outlet barrier seal.

[0059] On the other hand, the flow guiding device includes an enlarged channel inlet adapted to receive a portion of a flexible portion of the outlet barrier, wherein the flexible portion of the outlet barrier includes the valve sealing surface, and wherein the opening configuration of the flow communication unit further includes the enlarged channel inlet receiving a portion of the flexible portion of the outlet barrier in the forced configuration, wherein the outlet barrier seal is not provided.

[0060] On the other hand, the outlet barrier provides the outlet sealing member, thereby reducing the number of components.

[0061] In some embodiments and another aspect, the distal support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier, and wherein... - The distal support member further includes a spacer member adapted to separate the supported outlet barrier from the distal support member, thereby providing space between the distal support member and the outlet barrier. - The outlet barrier includes an actuator portion that provides the outlet sealing member and is movably disposed between a first position and a second position relative to the spacer member, and is adapted to be configured to be in: (i) An unconnected configuration, wherein the outlet barrier is in the closed configuration, wherein the closed configuration of the outlet barrier further includes the actuator portion in the first position relative to the spacer member, whereby the second outlet valve member is adapted to cooperate with the first outlet valve member to provide an outlet barrier seal, the outlet barrier seal being adapted to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a second threshold, wherein the second threshold defines the tightness of the outlet barrier seal and is greater than the first threshold. (ii) A connection configuration wherein the outlet barrier is in the flow configuration, wherein the flow configuration of the outlet barrier further includes the actuator portion in a second position relative to the spacer member, whereby the second outlet valve member is adapted to cooperate with the first outlet valve member to provide the outlet barrier seal, the outlet barrier seal being adapted to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a first threshold, wherein the first threshold defines the tightness of the outlet barrier seal.

[0062] On the other hand, the actuator portion is adapted to be manipulated from the first position to the second position by the flow guiding device when connected.

[0063] On the other hand, the flow communication unit is also adapted to be in the following position: (i) the unconnected structure, wherein the tightness of the barrier seal is defined by a second threshold, and (ii) the connection configuration, wherein the tightness of the barrier seal is defined by the first threshold.

[0064] On the other hand, the flow guiding device includes a sealing member adapted to cooperate with the outlet sealing member of the flow guiding device.

[0065] In some embodiments and in another, the flow communication unit further includes a support member comprising a proximal end and a proximal portion, the proximal portion being adapted to support the proximal valve member.

[0066] On the other hand, the support member is rigid, wherein the proximal valve member is a self-sufficient valve, the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a tight proximal fluid seal is provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0067] On the other hand, the support member is rigid, and the proximal portion of the support member includes a proximal valve housing adapted to accommodate a receiving portion of the self-sustaining valve.

[0068] On the other hand, the support member provides a portion of the first channel.

[0069] On the other hand, a portion of the first channel extends from the proximal end of the support member.

[0070] On the other hand, the self-sufficient valve includes a surface portion that provides a portion of the inlet surface for interfacing with the drug delivery device, and wherein the self-sufficient valve is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface.

[0071] On the other hand, the flow communication unit includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing a tight seal for the proximal fluid.

[0072] On the other hand, the flow communication unit includes an open configuration in which the self-sufficient valve is in the forced configuration, and in which the proximal fluid tight seal is not provided.

[0073] On the other hand, the proximal valve housing includes an enlarged channel portion adapted to receive the receiving portion, wherein the receiving portion of the self-sustaining valve includes a first proximal valve sealing surface and a second proximal valve sealing surface, wherein the receiving portion expands radially as the self-sustaining valve changes from the normal configuration to the forced configuration, and wherein the proximal valve housing is adapted to provide a stop for the radial expansion, thereby limiting the maximum expansion.

[0074] On the other hand, the support member also includes a support portion adapted to be supported by the drug delivery device, thereby providing support for the flow communication unit relative to the drug delivery device.

[0075] In some embodiments and in another, the support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier.

[0076] In another aspect, the distal portion includes a surface portion defining the first outlet valve member, the first outlet valve member being adapted to provide a seat sealing surface, wherein the outlet barrier includes a surface portion defining the second outlet valve member, which is adapted to provide a valve sealing surface, and wherein the outlet barrier seal is capable of being provided between the valve sealing surface and the seat sealing surface.

[0077] On the other hand, the outlet barrier includes a proximal surface portion for interfacing with the distal portion, and wherein the outlet barrier is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0078] On the other hand, the normally closed configuration of the flow communication unit also includes the outlet barrier being in the normal configuration and providing the outlet barrier seal.

[0079] On the other hand, the flow guiding device includes an enlarged channel inlet adapted to receive a portion of a flexible portion of the outlet barrier, wherein the flexible portion of the outlet barrier includes the valve sealing surface, and wherein the opening configuration of the flow communication unit further includes the enlarged channel inlet receiving a portion of the flexible portion of the outlet barrier in the forced configuration, wherein the outlet barrier seal is not provided.

[0080] In some embodiments and in another, the flow communication unit further includes a proximal support member, the proximal support member including a proximal end and a proximal portion, the proximal portion being adapted to support the proximal valve member.

[0081] On the other hand, the proximal valve component is a self-sufficient valve, the self-sufficient valve comprising: a first valve component including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve component including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal is provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0082] On the other hand, the proximal support member is rigid, and the proximal valve member includes a skirt adapted to surround and securely engage the proximal portion of the proximal support member.

[0083] On the other hand, the self-sufficient valve includes a surface portion that provides a portion of the inlet surface for interfacing with the drug delivery device, and wherein the self-sufficient valve is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface.

[0084] On the other hand, the flow communication unit includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing a tight seal for the proximal fluid.

[0085] On the other hand, the flow communication unit includes an open configuration in which the self-sufficient valve is in the forced configuration, and in which the proximal fluid tight seal is not provided.

[0086] On the other hand, the proximal portion of the proximal support member includes an enlarged channel portion adapted to receive a portion of a flexible portion of the self-sustaining valve, wherein the flexible portion includes a portion of the first proximal valve sealing surface and a portion of the second proximal valve sealing surface, wherein the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from the normal configuration to the forced configuration, and wherein the proximal portion is adapted to provide a stop for the axial deflection, thereby limiting a maximum deflection.

[0087] On the other hand, the proximal support member also includes a support portion adapted to be supported by the drug delivery device, thereby providing support for the flow communication unit relative to the drug delivery device.

[0088] In some embodiments and in another, the proximal support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier.

[0089] On the other hand, the proximal support member is rigid, and the distal portion of the proximal support member includes a surface portion defining the first outlet valve member, the first outlet valve member being adapted to provide a seat sealing surface, wherein the outlet barrier includes a surface portion defining the second outlet valve member, which is adapted to provide a valve sealing surface, and wherein the outlet barrier seal is capable of being provided between the valve sealing surface and the seat sealing surface.

[0090] On the other hand, the outlet barrier includes an inner surface portion for interfacing with the distal portion of the proximal support member, and wherein the outlet barrier is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0091] On the other hand, the normally closed configuration of the flow communication unit also includes the outlet barrier being in the normal configuration and providing the outlet barrier seal.

[0092] On the other hand, the proximal support member provides a proximal portion of the first channel.

[0093] On the other hand, the proximal portion of the first channel extends from the proximal end to the middle position.

[0094] On the other hand, a distal portion of the first channel is disposed between the distal portion and the outlet barrier, wherein the distal portion of the first channel extends from the intermediate position to the outlet.

[0095] In some implementations and in another, the outlet barrier provides an intermediate valve component.

[0096] On the other hand, the distal portion of the proximal support member is adapted to support the intermediate valve member.

[0097] On the other hand, the distal portion of the proximal support member includes a surface portion defining an intermediate valve seat adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal is capable of being provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0098] On the other hand, the intermediate valve member includes an inner surface portion for interfacing with the proximal support member, and wherein the intermediate valve member is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0099] On the other hand, the normally closed configuration of the flow communication unit also includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid.

[0100] On the other hand, the intermediate valve component is located in the distal portion of the first channel.

[0101] In some implementations and in another, the flow communication unit also includes a distal support member.

[0102] On the other hand, the distal support member includes a tubular portion adapted to receive a receiving portion of the outlet barrier, wherein the receiving portion expands radially as the outlet barrier changes from the normal configuration to the forced configuration, and wherein the tubular portion is adapted to provide a stop for the radial expansion, thereby limiting the maximum expansion.

[0103] On the other hand, the receiving portion of the outlet barrier includes the second outlet valve component, wherein the opening configuration of the flow communication unit further includes the outlet barrier in the forced configuration, and wherein the outlet barrier seal is not provided.

[0104] On the other hand, the receiving portion of the outlet barrier includes the intermediate valve member, wherein the opening configuration of the flow communication unit further includes the outlet barrier in the forced configuration, and wherein the intermediate fluid tight seal is not provided.

[0105] On the other hand, the distal support member also includes a support portion adapted to be supported by the proximal support member, thereby providing stability to the flow communication unit.

[0106] In some embodiments and in another, the flow communication unit further includes a distal sealing member that provides the outlet sealing member.

[0107] In some embodiments and in another, the distal support member is adapted to support the distal sealing member.

[0108] In some embodiments and in another, the proximal valve member further includes a support portion adapted to be supported by the drug delivery device (210), thereby providing support for the flow communication unit relative to the drug delivery device (210).

[0109] On the other hand, the proximal valve member is adapted to be fitted into the top of the adapter, the top of the adapter having a retaining member on its inner surface, wherein the proximal valve member includes a flat distal surface and a recess adapted to receive the retaining member when the proximal valve member is inserted into the top of the adapter, and thereby the distal surface remains flat to allow close contact with another flat surface.

[0110] In some embodiments and in another, the flow communication unit further includes a proximal support member, the proximal support member including a proximal end and a proximal portion, the proximal portion being adapted to support the proximal valve member.

[0111] On the other hand, the proximal support member is rigid, wherein the proximal valve member is a self-sufficient valve, the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a tight proximal fluid seal is provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0112] On the other hand, the proximal support member is rigid and has a flat proximal surface, and the self-sustaining valve includes a substantially flat distal surface, and the proximal support member is adapted to transmit compressive force to the self-sustaining valve, and the self-sustaining valve is adapted to transmit compressive force to the drug delivery device.

[0113] On the other hand, the proximal support member is rigid, and wherein the proximal support member is adapted to be fitted into the top of the adapter, the top of the adapter having a retaining member on its inner surface, and wherein the proximal support member includes a flat proximal surface adapted to be supported by the retaining member, and thereby the proximal surface can be held in close contact with the flat distal surface of the self-sustaining valve (898) when the proximal support member and the self-sustaining valve are inserted into the top of the adapter.

[0114] On the other hand, the proximal support member is rigid and provides the proximal portion of the first channel.

[0115] On the other hand, the proximal portion of the first channel provided by the proximal support member extends from the proximal end of the proximal support member.

[0116] On the other hand, the self-sufficient valve includes a surface portion that provides a portion of the inlet surface for interfacing with the drug delivery device, and wherein the self-sufficient valve is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface.

[0117] On the other hand, the flow communication unit includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing a tight seal for the proximal fluid.

[0118] On the other hand, the flow communication unit includes an open configuration in which the self-sufficient valve is in the forced configuration, and in which the proximal fluid tight seal is not provided.

[0119] On the other hand, the proximal portion of the proximal support member includes an enlarged channel portion adapted to receive a portion of a flexible portion of the self-sustaining valve, wherein the flexible portion includes a portion of the first proximal valve sealing surface and a portion of the second proximal valve sealing surface, wherein a portion of the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from the normal configuration to the forced configuration, and wherein the proximal portion is adapted to provide a stop for the axial deflection, thereby limiting a maximum deflection.

[0120] In some embodiments and in another, the flow communication unit further includes an intermediate valve component.

[0121] On the other hand, the proximal support member includes a distal end and a distal portion, the distal portion being adapted to support the intermediate valve member.

[0122] On the other hand, the proximal support member is rigid, and the distal portion of the proximal support member includes a surface portion defining an intermediate valve seat adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal is possible between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0123] On the other hand, the proximal portion of the first channel extends from the proximal end to the distal end.

[0124] In another aspect, the intermediate valve member includes a proximal surface portion for interfacing with the distal portion of the proximal support member, and wherein the intermediate valve member is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0125] On the other hand, the normally closed configuration of the flow communication unit also includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid.

[0126] In some implementations and in another, the flow communication unit also includes a distal support member.

[0127] On the other hand, the distal support member is rigid and provides the distal portion of the first channel.

[0128] On the other hand, the distal support member includes an enlarged channel portion adapted to receive a portion of a flexible portion of the intermediate valve member, wherein the flexible portion of the intermediate valve member includes the intermediate valve sealing surface, and wherein the opening configuration of the flow communication unit further includes the enlarged channel portion receiving a portion of the flexible portion of the intermediate valve member in the forced configuration, wherein the intermediate fluid tight seal is not provided.

[0129] On the other hand, the proximal support member, the intermediate valve member, and the distal support member are provided with units, wherein a portion of the intermediate valve member is clamped between the support members, and wherein the support members are welded together by ultrasonic welding.

[0130] On the other hand, the clamped portion is fixed, while the unclamped portion is flexible and adapted to move between the normal configuration and the forced configuration.

[0131] In some embodiments and in another, the distal support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier.

[0132] On the other hand, the distal support member is rigid, wherein the outlet barrier is a self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal is provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0133] On the other hand, the self-sufficient valve includes a proximal surface portion for covering the first channel, and wherein the self-sufficient valve is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure in the first channel and thus in response to fluid pressure on the proximal surface portion of the self-sufficient valve.

[0134] On the other hand, the normally closed configuration of the flow communication unit includes the self-sufficient valve in the normal configuration, thereby providing a tight seal for the proximal fluid.

[0135] On the other hand, the opening configuration of the flow communication unit includes the self-sufficient valve in the forced configuration, wherein the proximal fluid tight seal is not provided.

[0136] On the other hand, the proximal portion of the proximal support member includes an enlarged channel portion adapted to receive a portion of a flexible portion of the self-sustaining valve, wherein the flexible portion includes a portion of the first proximal valve sealing surface and a portion of the second proximal valve sealing surface, wherein a portion of the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from the normal configuration to the forced configuration, and wherein the proximal portion is adapted to provide a stop for the axial deflection, thereby limiting a maximum deflection.

[0137] On the other hand, the distal support member is rigid and has a flat distal surface, and the self-sufficient valve includes a substantially flat proximal surface, and the distal support member is adapted to transmit compressive force to the outlet barrier, and the outlet barrier is adapted to transmit compressive force to the top of the adapter.

[0138] On the other hand, the proximal support member is rigid, and wherein the proximal support member, the intermediate valve member, the distal support member, and the outlet barrier are adapted to be fitted into the top of the adapter, the top of the adapter having a retaining member on its inner surface, and wherein the proximal support member includes a flat proximal surface adapted to be supported by the retaining member, and thereby the proximal surface is able to maintain close contact with the flat distal plane of the proximal valve member when all members are inserted into the top of the adapter.

[0139] On the other hand, the proximal support member, the intermediate valve member, and the distal support member provide a unit, wherein a portion of the intermediate valve member is clamped between the support members, and wherein the unit is adapted to be assembled into an adapter top having a unit retaining member adapted to hold the unit in a compressed state.

[0140] On the other hand, the outlet barrier and the unit are adapted to be held in the top of the adapter in a compressed state, wherein the holding member is capable of transmitting the compressive force to the unit, and the unit is capable of transmitting the compressive force to the holding surface on the top of the adapter.

[0141] On the other hand, the outlet barrier and the unit are adapted to be held in the top of the adapter in a compressed state, wherein the proximal valve member is adapted to be fitted into the top of the adapter in a compressed state, and wherein the top of the adapter includes a device retaining member on its inner surface, wherein the device retaining member is adapted to connect the top of the adapter to the drug retaining device, wherein the proximal valve member is supported by the drug delivery device in a compressed state.

[0142] On the other hand, the flow guiding device includes an enlarged channel inlet adapted to receive a portion of a flexible portion of the self-sustaining valve, wherein the flexible portion of the self-sustaining valve includes a portion of the outlet barrier seal, and wherein the opening configuration of the flow communication unit further includes the enlarged channel inlet receiving a portion of the flexible portion of the outlet barrier in the forced configuration, wherein the outlet barrier seal is not provided.

[0143] On the other hand, the outlet barrier provides the outlet sealing member.

[0144] On the other hand, the distal support member includes a distal end and a distal portion, the distal portion being adapted to support the outlet barrier, wherein... - The distal support member further includes a spacer member adapted to separate the supported outlet barrier from the distal support member, thereby providing space between the distal support member and the outlet barrier, and - The outlet barrier includes an actuator portion that provides the outlet sealing member and is movably disposed between a first position and a second position relative to the spacer member, and is adapted to be configured to be in: (i) An unconnected configuration, wherein the outlet barrier is in the closed configuration, wherein the closed configuration of the outlet barrier further includes the actuator portion in the first position relative to the spacer member, whereby the second outlet valve member is adapted to cooperate with the first outlet valve member 854 to provide an outlet barrier seal, the outlet barrier seal being adapted to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a second threshold, wherein the second threshold defines the tightness of the outlet barrier seal and is greater than the first threshold. (ii) A connection configuration, wherein the outlet barrier is in the flow configuration, wherein the flow configuration of the outlet barrier further includes the actuator portion in a second position relative to the spacer member, whereby the second outlet valve member is adapted to cooperate with the first outlet valve member to provide an outlet barrier seal, the outlet barrier seal being adapted to allow a drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to a pressure in the first channel exceeding a first threshold, wherein the first threshold defines the tightness of the outlet barrier seal, whereby the actuator portion is adapted to be manipulated by the flow guiding device from the first position to the second position upon connection.

[0145] On the other hand, the flow communication unit is also adapted to be in the following position: (i) the unconnected structure, wherein the tightness of the barrier seal is defined by a second threshold, and (ii) the connection configuration, wherein the tightness of the barrier seal is defined by the first threshold.

[0146] On the other hand, the flow guiding device includes a sealing member adapted to cooperate with an outlet sealing member disposed on the outlet barrier.

[0147] On the other hand, the outlet barrier is stretched by the sealing member of the flow guiding device, wherein the first outlet sealing member and the second outlet sealing member are pulled apart from each other, thereby reducing the strength of the fluid tight outlet seal.

[0148] In some embodiments and in another, the proximal valve member provides the channel inlet in its normal configuration, wherein the valve is closed.

[0149] On the other hand, the proximal valve member provides a channel passage in a forced configuration, wherein the valve is open.

[0150] On the other hand, the proximal valve member includes a distal surface portion for interfacing with a movable channel member, and wherein the proximal valve member is flexible and capable of changing from a normal configuration to a forced configuration in response to pressure from the movable channel member on the distal surface portion.

[0151] In some embodiments and in another, the flow communication unit further includes a proximal support member, the proximal support member including a proximal end and a proximal portion, the proximal portion being adapted to support the proximal valve member.

[0152] On the other hand, the proximal support member is rigid, and the proximal valve member is a self-sufficient valve, the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a tight proximal fluid seal is provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0153] On the other hand, the proximal support member is rigid, and the self-sustaining valve includes a skirt adapted to surround and / or be surrounded by the proximal portion of the proximal support member, thereby fixing the self-sustaining valve and the proximal support member together.

[0154] On the other hand, the self-sustaining valve includes: a proximal surface portion that provides a portion of the inlet surface for interfacing with the drug delivery device; and a distal surface portion for interfacing with a movable channel member, wherein the self-sustaining valve is flexible, and (i) wherein the self-sustaining valve is capable of changing from a normal configuration to a forced configuration in response to pressure from the movable channel member on the distal surface portion, and (ii) wherein the movable channel member supports the self-sustaining valve in the normal configuration in response to fluid pressure on the inlet surface, thereby maintaining a tight fluid seal.

[0155] On the other hand, the flow communication unit includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing a tight seal for the proximal fluid.

[0156] On the other hand, the flow communication unit includes an open configuration, wherein the self-sufficient valve is in the forced configuration, and the channel inlet is provided by the movable channel member, wherein the proximal fluid tight seal is not provided.

[0157] On the other hand, the proximal portion of the proximal support member is adapted to receive a portion of the defined channel seat portion of the self-sustaining valve, wherein the channel seat portion is adapted to provide a seat for the proximal portion of the movable channel member in a distal position, and wherein the self-sustaining valve is in the forced configuration.

[0158] On the other hand, the proximal portion of the proximal support member is adapted to receive a portion of the defined channel seat portion of the self-sustaining valve, wherein the channel seat portion is adapted to provide a seat for the distal portion of the movable channel member in a proximal position, wherein the movable channel member extends across the self-sustaining valve, wherein the self-sustaining valve provides a seal around the movable channel member, and wherein the self-sustaining valve is in the forced configuration.

[0159] On the other hand, the proximal support member also includes a support portion adapted to be supported by the drug delivery device, thereby providing support for the flow communication unit relative to the drug delivery device.

[0160] In some embodiments and in another, the proximal support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier.

[0161] In some embodiments, and in another aspect, the flow communication unit further includes a distal support member.

[0162] On the other hand, the proximal support member includes a tubular portion adapted to receive the distal support member, wherein the distal support member is movably disposed within the tubular portion, and wherein the distal support member is adapted to move between a distal position and a proximal position.

[0163] On the other hand, the distal support member includes a proximal end and a proximal portion, the proximal portion including a movable channel member.

[0164] On the other hand, the distal support member includes a distal end and a distal portion, the distal portion being adapted to support the exit barrier.

[0165] On the other hand, the distal support member is rigid, and the distal portion of the distal support member includes a surface portion defining the first outlet valve member, the first outlet valve member being adapted to provide a seat sealing surface, wherein the outlet barrier includes a surface portion defining the second outlet valve member, which is adapted to provide a valve sealing surface, and wherein the outlet barrier seal is capable of being provided between the valve sealing surface and the seat sealing surface.

[0166] On the other hand, the outlet barrier includes an inner surface portion for interfacing with the distal portion of the distal support member, and wherein the outlet barrier is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0167] On the other hand, the normally closed configuration of the flow communication unit also includes the outlet barrier being in the normal configuration and providing the outlet barrier seal.

[0168] On the other hand, the proximal portion of the distal support member provides the proximal portion of the first channel.

[0169] On the other hand, the proximal portion of the first channel extends from the proximal end to the middle position.

[0170] On the other hand, the distal portion of the first channel is disposed between the distal portion and the outlet barrier, and wherein the distal portion of the first channel extends from the intermediate position to the outlet.

[0171] On the other hand, the flow communication unit also includes a biasing member adapted to bias the distal support member toward the distal position.

[0172] On the other hand, the biasing member is located between the distal surface of the proximal support member and the proximal surface of the distal support member (993).

[0173] On the other hand, the biasing member is a compression spring.

[0174] In some implementations and in another, the outlet barrier provides an intermediate valve component.

[0175] On the other hand, the distal portion of the distal support member is adapted to support the intermediate valve member.

[0176] On the other hand, the distal portion of the distal support member includes a surface portion defining an intermediate valve seat adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal is capable of being provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0177] On the other hand, the intermediate valve member includes an inner surface portion for interfacing with the distal support member, and wherein the intermediate valve member is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0178] On the other hand, the normally closed configuration of the flow communication unit also includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid.

[0179] On the other hand, the intermediate valve component is located in the distal portion of the first channel and provides additional security.

[0180] In some implementations and in another, the outlet sealing member is provided by the outlet barrier.

[0181] In some embodiments, and in another aspect, the flow connectivity unit further includes: - A central portion extending from the inlet surface to the outlet surface, wherein the central portion provides a portion of the inlet surface and the outlet surface, and wherein the central portion includes the first flow channel, the central portion also including a side surface extending in one direction between the inlet surface and the outlet surface, wherein the channel outlet and the first outlet valve member are disposed in the side surface, and wherein the first outlet valve member surrounds the channel outlet. - wherein the outlet barrier surrounds the central portion and provides the second outlet valve component, wherein the outlet barrier is movably arranged and capable of moving between a distal position and a proximal position. - Wherein, when the outlet barrier is located in the proximal position, the outlet surface can be arranged as the connection configuration. - Wherein, when the outlet barrier is located at the distal position, the outlet surface can be arranged in the unconnected configuration. - A circumferential portion connected to the central portion provides the intermediate surface, the intermediate surface extending between the inlet surface and the outlet surface, wherein the circumferential portion includes a portion of the inlet surface and the outlet surface. - Wherein, for any of the connected and unconnected configurations, the inlet surface, the outlet surface, and the intermediate surface define the outer surface and restrict the internal space of the flow communication unit, wherein the outlet barrier is located proximal or distal. - wherein the outlet sealing member is disposed on the side surface of the central portion, wherein the outlet sealing member surrounds the channel outlet, thereby providing a portion of the outlet surface in the connection configuration. - Wherein the outlet barrier provides a portion of the outlet surface, - Wherein, when the outlet surface is in the unconnected configuration, the outlet surface provided by the outlet barrier is flush with the outlet portion provided by the central portion and the circumferential portion, thereby making it easier to keep the outlet surface clean, and - Wherein, when the outlet surface is in the connection configuration, the outlet surface provided by the outlet barrier is partially recessed relative to the outlet surface provided by the central portion and the circumferential portion. - wherein the second outlet valve component is adapted to cooperate with the first outlet valve component to provide an outlet barrier seal, wherein the outlet barrier is adapted to be in: (i) A closed configuration, wherein the outlet surface is in the unconnected configuration, whereby the outlet barrier is in the distal position, and whereby the outlet barrier seal is adapted to reduce the entry of contaminants, and (ii) A flow configuration wherein the outlet surface is in the connection configuration, thereby the outlet barrier is in the proximal position, thereby the outlet barrier is adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to the pressure in the first channel being higher than the first threshold. - The flow communication unit is further adapted to be in: (i) the unconnected configuration, which responds to disconnecting the flow communication unit from the flow guiding device—and wherein the outlet barrier is permitted to be in the closed configuration, and (ii) the connection configuration, responsive to connecting the flow communication unit to the flow guiding device, wherein the outlet barrier is permitted to be in the flow state, wherein the outlet sealing member is arranged to contact the flow guiding device to provide the channel seal downstream of the channel outlet, thereby allowing flow communication between the channel outlet and the flow guiding device, wherein the channel outlet for the first channel is arranged at the outlet surface of the flow communication unit; and - Wherein, when the channel inlet is arranged in flow communication with the drug delivery device and the flow communication unit is in the connection configuration, a combined flow channel can be provided between the drug delivery device, the first channel and the flow guiding device, wherein the channel seal is arranged downstream of the channel outlet; - Thus, the flow communication unit is adapted to enable long-term use of the reusable drug delivery device, and thus, the flow communication unit is adapted to inhibit the entry of microorganisms into the reusable drug delivery device during long-term use.

[0182] On the other hand, the flow communication unit further includes an outlet barrier locking member adapted to be released by the flow guiding device during connection, wherein the outlet barrier is further adapted to be in the following position: (i) the closed configuration, wherein the outlet surface is in the unconnected configuration, wherein the outlet barrier is locked in the distal position by the outlet barrier locking member, and (ii) A flow configuration in which the outlet surface is in the connection configuration, wherein the outlet barrier is released and allowed to move to the proximal position.

[0183] On the other hand, the flow communication unit includes a closure for the reusable drug delivery device, the closure being adapted to allow the drug formulation to be removed without removing or destroying the closure.

[0184] On the other hand, the barrier locking member is also adapted to be released by the connecting member of the flow guiding device.

[0185] In some embodiments and in another, the drug delivery system includes a flow communication unit, a drug delivery device, and a flow guiding device as described in this disclosure.

[0186] On the other hand, the drug delivery system also includes a cover for integrating the flow communication unit with the drug delivery device.

[0187] On the other hand, the distal support member and the cover are adapted to clamp a portion of the outlet barrier, and thus the clamped portion is fixed while the unclamped portion is adapted to move between the normal configuration and the forced configuration. Attached Figure Description

[0188] The following embodiments of the invention will be described with reference to the accompanying drawings, wherein: Figure 1A , 1B An example of a drug delivery device in the form of an injection device is shown. The injection device is shown with and without a protective cap.

[0189] Figure 1C A pressurized drug reservoir in cartridge form is shown, which can be inserted. Figure 1A and 1B In the drug delivery device shown.

[0190] Figure 1D An example of a drug delivery device in the form of an infusion pump is shown. The drug delivery device is shown as having a pump barrel to be inserted into the drug delivery device.

[0191] Figure 1E An infusion set that can be used in combination with embodiments of this disclosure is shown.

[0192] Figures 2A to 2C The cross-sectional view illustrates an embodiment of a drug delivery system in different assembly states according to the present disclosure, wherein the system includes a flow guiding device, a flow communication unit having a needleless interface for interfacing with a drug delivery device, and a drug delivery device.

[0193] Figures 3A to 3C A cross-sectional view illustrates another embodiment of a drug delivery system according to the present disclosure in different assembly states, wherein the system includes a flow guiding device, a flow communication unit having a puncture needle to establish flow communication with a drug delivery device, and a drug delivery device.

[0194] Figures 4A to 4C A cross-sectional view illustrates another embodiment of a drug delivery system in different assembly states according to the present disclosure, wherein the system includes a flow guiding device, a flow communication unit having an actuable puncture needle to establish flow communication with a drug delivery device, and a drug delivery device.

[0195] Figure 5A A cross-sectional view is shown of an embodiment of a drug delivery system according to the present disclosure, wherein a flow communication unit is connected to the drug delivery system.

[0196] Figure 5B A cross-sectional view is shown. Figure 5AA drug delivery system in which a flow communication unit is connected to a drug delivery device and a flow guidance device.

[0197] Figure 5C It shows Figure 5A An exploded diagram of a drug delivery system.

[0198] Figure 5D The left panel shows Figure 5A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0199] Figure 5E The left panel shows Figure 5B A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0200] Figure 6A A cross-sectional view illustrates an embodiment of a drug delivery system according to the present disclosure, wherein a flow communication unit is connected to a drug delivery device and a flow guiding device.

[0201] Figure 6B It shows the absence of a flow guide device. Figure 6A An exploded diagram of a drug delivery system.

[0202] Figure 6C The left panel shows the absence of a flow guide device. Figure 6A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0203] Figure 6D The left panel shows Figure 6A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0204] Figure 6E It shows Figure 6A A three-dimensional diagram of a drug delivery system.

[0205] Figure 6F It shows Figure 6A A three-dimensional diagram of the drug delivery system, further showing details of the off-center position of the channel outlet.

[0206] Figure 7A A cross-sectional view illustrates an embodiment of a drug delivery system according to the present disclosure, wherein a flow communication unit is connected to a drug delivery device and a flow guiding device.

[0207] Figure 7B It shows Figure 7A An exploded diagram of a drug delivery system.

[0208] Figure 7C The left panel shows the absence of a flow guide device. Figure 7AA close-up of the drug delivery system, while the right panel shows details of the left panel.

[0209] Figure 7D The left panel shows Figure 7A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0210] Figure 8A A cross-sectional view illustrates an embodiment of a drug delivery system according to the present disclosure, wherein a flow communication unit is connected to a drug delivery device and a flow guiding device.

[0211] Figure 8B It shows Figure 8A An exploded diagram of a drug delivery system.

[0212] Figure 8C The left panel shows the absence of a flow guide device. Figure 8A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0213] Figure 8D The left panel shows Figure 8A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0214] Figure 8E An embodiment of a drug delivery system according to this disclosure is shown.

[0215] Figure 8F A cross-sectional view is shown of an embodiment of the drug delivery system according to this disclosure.

[0216] Figure 9A A cross-sectional view of an embodiment of a drug delivery system according to the present disclosure is shown, wherein a flow communication unit is connected to a drug delivery device. The figure also shows a flow guiding device.

[0217] Figure 9B It shows Figure 9A An exploded diagram of a drug delivery system.

[0218] Figure 9C The left panel shows the absence of a flow guide device. Figure 9A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0219] Figure 9D The left panel shows Figure 9A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0220] Figure 10A A cross-sectional view is shown of an embodiment of the drug delivery system according to the present disclosure, wherein the exit barrier is locked in a distal position.

[0221] Figure 10B A cross-sectional view is shown. Figure 10A The drug delivery system in which the outlet barrier is released and moved to a proximal position.

[0222] Figure 10C The upper part is shown in cross-section. Figure 10A The diagram shows a drug delivery system in which the outlet barrier is locked in a distal position. The figure also illustrates the accompanying flow guidance device. Details are shown at the bottom.

[0223] Figure 10D The left panel is shown in cross-section. Figure 10A The drug delivery system includes an outlet barrier that is released and moved to a proximal position. Details are shown on the right panel.

[0224] Figure 10E It shows Figure 10A The delivery system is in a disconnected configuration.

[0225] Figure 10F It shows Figure 10A The delivery system is in a connected structure.

[0226] Figure 10G The delivery system shown in Figure 10 is in an assembled state, comprising a drug delivery device and a flow guiding device. All components, flow communication units, drug delivery devices, and flow guiding devices may be equipped with check valves.

[0227] Figure 11A A cross-sectional view of an embodiment of the drug delivery system according to the present disclosure is shown, wherein a flow communication unit is connected to a drug delivery device. The cross-section is parallel to the longitudinal axis between the two channel outlets. The figure also shows a flow guiding device.

[0228] Figure 11B A cross-sectional view of an embodiment of the drug delivery system according to this disclosure is shown, wherein a flow communication unit is connected to a drug delivery device. The cross-section is parallel to the radial axis of the channel outlet. The figure also shows a flow guiding device.

[0229] Figure 11C It shows Figure 11A An exploded diagram of a drug delivery system.

[0230] Figure 11D The left panel shows the absence of a flow guide device. Figure 11A A close-up of the drug delivery system, while the right panel shows details of the left panel.

[0231] Figure 11E It shows Figure 11A A close-up of a drug delivery system.

[0232] Figure 12A A cross-sectional view of an embodiment of the drug delivery system according to this disclosure is shown, wherein a flow communication unit is connected to a drug delivery device. The cross-section is parallel to the radial axis of the channel outlet. The figure also shows a flow guiding device.

[0233] Figure 12B It shows Figure 12A Details of the drug delivery system are marked with circles.

[0234] Figure 12C It shows Figure 12A An exploded diagram of a drug delivery system.

[0235] Figure 12D It shows Figure 12A A close-up of a drug delivery system.

[0236] Figure 12E It shows Figure 12A A close-up of the drug delivery system, connected to a flow guide device.

[0237] Figure 12F The left panel shows the connection before the flow guide device. Figure 12A A three-dimensional diagram of the drug delivery system, with the right panel showing the process during connection with the flow guiding device and before the release outlet barrier locks. Figure 12A A three-dimensional diagram of a drug delivery system.

[0238] In the accompanying drawings, similar structures are identified primarily by similar reference numerals. Detailed Implementation

[0239] When using terms such as “up” and “down,” “right” and “left,” “horizontal” and “vertical,” or similar relative expressions, these terms are for reference only with respect to the accompanying drawings and do not necessarily represent the actual usage context. The accompanying drawings are schematic representations, and therefore the construction of different structures and their relative dimensions are for illustrative purposes only. When the term “component” is used with respect to a given part, it can be used to define a single part or a portion of a part that has one or more functions.

[0240] In reversing the implementation of the present invention itself Previously, examples of automated drug delivery devices in the form of automated injection devices for multi-dose injections and drug delivery devices in the form of continuous infusion devices were described. The described drug delivery devices provide the basis for exemplary embodiments of the present invention.

[0241] The described automated drug delivery device is a prior art repositionable up / down flick automated drug delivery device. The pen device 100 includes a cap portion 107 and a main portion having a proximal body or drive assembly portion with a housing 101, in which a drug dispensing mechanism is arranged or integrated, and the main portion having a distal cartridge holder portion 110, in which a transparent cartridge 120 filled with drug and having a distal needle-permeable diaphragm is arranged and held in place by a cartridge holder attached to the proximal portion, the cartridge holder having a pair of opposing openings 111 allowing inspection of a portion of the cartridge. A distal coupling device 115 allows the needle assembly to be releasably mounted in flow communication with the interior of the cartridge. The cartridge is provided with a piston driven by a piston rod forming part of the dispensing mechanism and can, for example, contain insulin, GLP-1, or growth hormone preparations. The rotatable dose setting member 140 on the nearest side is used to manually set the desired drug dose shown in the display window 102, which can then be dispensed when the button 190 is actuated. Depending on the type of dispensing mechanism implemented in the drug delivery device, the dispensing mechanism may include a torsion spring, as in the illustrated embodiment, which is tensioned during dose setting and then released when the release button is actuated to drive the piston rod. More specifically, during dose setting, the drive member to which the spring is connected rotates to a rotational position corresponding to the set dose, thereby energizing the drive member. A graduated cylinder with dose size numbers is coupled to the drive member such that the size of the currently set dose is shown in the display window, for example, by means of a threaded connection to the housing. To prevent rotation of the drive member, the dose setting mechanism is provided with a holding mechanism, which in this exemplary embodiment is in the form of a ratchet mechanism (not shown in the figures). When the user wishes to dispense the set dose, the button is actuated, thereby engaging the drive member with the piston rod drive mechanism, and the holding mechanism is subsequently released.

[0242] although Figure 1A , 1B 1C illustrates a pre-filled type of drug delivery device, i.e., the device is provided with a pre-installed cartridge and is discarded when the cartridge has been emptied. However, in alternative embodiments, the drug delivery device can be a durable device designed to allow the cartridge assembly to be replaced, for example, in the form of a cartridge assembly including a cartridge mounted in a cartridge holder. Such an assembly may further be provided with a pre-installed piston rod.

[0243] Figure 1D A drug delivery device 150 in the form of a continuous infusion pump is shown, as disclosed in Medtronic Minimed in US6248093. The figure shows a pump housing 160, a pump barrel 170, and a needle holder 180 for the infusion set. Figure 1EAn infusion set with a needle hub 180 is shown.

[0244] Preservatives are typically required to prevent the long-term or repeated growth of microorganisms or bacteria in pharmaceutical formulations. In products from NovoNordisk A / S, one or both of the preservatives phenol and m-cresol are used to ensure that minor microbial contamination does not grow during the intended lifespan of the multi-dose injectable. However, phenol and m-cresol are toxic (which is necessary for them to function as intended) and can therefore cause injection site reactions as side effects, or allergic reactions in some cases. This also means additional limitations when selecting new protein / peptide drugs, as they require stability against preservatives, especially when the drug product is intended for daily or weekly use. Therefore, in some cases, it is preferable to reduce or omit the addition of preservatives to a given drug. It should be noted that substances considered preservatives can be added in lower amounts to act as stabilizers for pharmaceutical substances (such as insulin substances).

[0245] To ensure that antimicrobial requirements can be met without adding preservatives to the drug itself, two main issues must be addressed. First, it must be ensured that a contaminated needle or cannula cannot be inserted into the cartridge and introduce microbial contamination into the cartridge. Second, it must be ensured that backflow through the cannula is impossible, as this would introduce the risk of microbial contamination through the backflow of bodily fluids from the user. This concept should not be confused with known arrangements that provide a reservoir filled with preservatives to allow the hypodermic needle to be safely used more than once, for example, as disclosed in US 3,354,881 and WO 2014 / 064100.

[0246] Flow Connectivity Unit Referring to Figures 2 to 4, exemplary embodiments of a drug delivery system are illustrated to describe different assembly states of the system according to this disclosure and to describe common features. Drug delivery systems 200, 300, and 400 are adapted for subcutaneous drug delivery during long-term use. The drug delivery system includes the following components: (i) a reusable drug delivery device 210 including a reservoir 211 containing a drug formulation that allows for microbial growth after introduction into the reservoir during long-term use; (ii) a flow guiding device 230; and (iii) a flow communication unit 240 adapted to connect to the reusable drug delivery device and the flow guiding device and adapted to allow fluid to flow from the drug delivery device to the flow guiding device and to restrict contaminants from entering the drug reservoir. In other words, the flow communication unit is adapted to promote antimicrobial conditions for the drug formulation, wherein if the drug formulation is contaminated with microorganisms, the drug formulation itself can allow microbial growth and may contain a low concentration of preservatives to preserve the drug formulation. More specifically, the flow communication unit is adapted to promote antimicrobial conditions by preventing the introduction of microorganisms, which can be achieved by the features described in this disclosure.

[0247] The illustrated drug delivery device 210 includes a reservoir 211 containing a volume of preservative-free liquid drug or a low concentration of preservative, and this volume of liquid drug can be delivered during long-term use. Delivery during long-term use can be used to describe a drug treatment regimen or delivery method in which a drug delivery device suitable for the purpose will be used to deliver the drug via infusion or multiple injections. For example, and more specifically, a medical regimen specifying delivery during long-term use may include (i) delivery of multiple smaller volumes (one smaller volume) in the form of near-continuous delivery via infusion, (ii) delivery of multiple larger volumes (one larger volume) via high-dose delivery via infusion, or (iii) delivery of multiple larger volumes (one larger volume) via high-dose delivery via multiple injections.

[0248] In this context, a smaller volume can be understood as a volume smaller than a larger volume, where the drug, for example, could be U100 insulin, and the reservoir comprises 300 units of 3 ml each. In this case, the volume of each unit is 0.01 ml. Depending on the increment step of the dosing mechanism or the travel volume of the drug delivery device, the smaller volume could be, for example, 0.001 ml or 0.01 ml, or the volume within the interval between two examples. Similarly, the larger volume could be 0.01 ml or 0.10 ml, or the volume within the interval between two examples.

[0249] In the same context, near-continuous drug delivery can be the delivery of multiple smaller volumes within a series of short delivery intervals (a single short delivery interval), such as 5 seconds, 60 seconds, or 300 seconds, and the duration of use may be longer (longer periods), such as multiple calendar days, for example, 3 calendar days. In this case, the flow guidance device may include an infusion device or catheter capable of subcutaneous delivery to the subject.

[0250] In the same context, high-dose drug delivery can be the delivery of a large volume over multiple large delivery intervals (one large delivery interval), such as one hour or one calendar day, with longer durations of use, such as multiple calendar days, for example, three calendar days. In this case, the flow guidance device may include an infusion needle or infusion catheter capable of subcutaneous delivery to the subject.

[0251] In the same context, multiple injections of a drug can be the delivery of multiple larger volumes over multiple larger delivery intervals (one larger delivery interval), such as 1 hour, one calendar day, or one week. Long-term use may be longer, such as over multiple calendar days, such as 3 or more weeks, such as 5 weeks, and the flow guiding device may include an injection needle for subcutaneous delivery to the subject.

[0252] The drug delivery device also includes pressure mechanisms 214 and 215, adapted to apply pressure to the liquid drug in the reservoir. Because... Figure 2A , 3A The main purpose of section 4A is to illustrate the assembly state and common features before assembly; therefore, the pressure mechanism is only represented by dashed rectangles 214 and 215 in the figure. However, as an example, the pressure mechanism can be represented as a compressible reservoir including cylinder 214 and piston 215, such as... Figure 5A As shown. By controlling the pressure mechanism, the reservoir can be (i) in a pressurized state, where the pressure mechanism pressurizes the liquid drug, and (ii) in a depressurized state. The depressurized state is defined as a state where the pressure mechanism does not pressurize the liquid drug, and the drug pressure is the same as the pressure outside the reservoir, i.e., atmospheric pressure or the pressure of the surrounding environment. In both states, the pressure mechanism can prevent backflow into the reservoir because the pressure in the reservoir is equal to or higher than the pressure of the surrounding environment. Therefore, to prevent backflow, as described above, the injection device can operate in both pressurized and depressurized states. Alternatively, backflow can be prevented by arranging a check valve in the injection device, flow communication unit, or flow guiding device.

[0253] The drug delivery device also includes a storage outlet 212 for the drug to flow out of the storage tank. The outlet is located at... Figure 2A , 2CIn 3C and 4C, they are indicated by solid dots 212 and 312. Dashed arrow 213 indicates the direction of flow out of the storage tank. The actual location or arrangement of outlets 212 and 312 depends on the interface with the flow communication unit and how the flow communication is established. Figure 2A and 2C One embodiment is shown in which the flow communication unit serves as a closure, and the reservoir of the drug delivery device is open before assembly. Figure 2A ), and after assembly it is closed ( Figure 2C During assembly, the flow communication unit is connected to the drug delivery device and the reservoir via a cap 280 (e.g., a metal cap), establishing flow communication in the interface. Therefore, the reservoir outlet is also located on the interface. This is consistent with... Figure 3A and 4A The embodiments shown differ in that the reservoir of the flow guiding device can be covered and sealed by a membrane (diaphragm), and the flow communication unit does not serve as the main closure. In these embodiments, the flow communication unit includes puncture needles 391 and 491 for puncturing the membrane sealing the reservoir, thereby establishing flow communication. For these embodiments, the outlet is arranged internally in the reservoir rather than at the interface. The puncture needle 391 shown in Figure 3 is fixedly mounted, while the puncture needle 491 shown in Figure 4 can be configured in a retracted position (…). Figure 4A and 4B ) and extended structures ( Figure 4C Between the two configurations, and where the needle actuator 437 can change the puncture needle between the two configurations.

[0254] The flow communication unit includes an inlet surface 241 for interfacing with the drug delivery device 210, and the inlet surface is in Figure 2A , 3A As shown on 4A. Figure 2A and 2B Embodiments of the assembly state before and after assembly are schematically shown, wherein the flow communication unit is assembled with the drug delivery device via a cap 280. Thus, the flow communication unit is connected to the drug delivery device. Alternatively, the cap can be replaced by an adapter top or code top, which also connects the flow communication unit to the drug delivery device, but also includes a connector for connection to a flow guiding device. Figure 3A , 4A The diagram schematically illustrates the assembly state before assembly. Figure 3B and 4B The diagram schematically illustrates the assembled state, where the flow communication unit is connected to the drug delivery device using connector 345. Connector 345 of the flow communication unit is adapted to mate with a corresponding connector on the drug delivery device. The connector on the drug delivery device is not shown in the figure. Connector 345 can be a threaded or bayonet connector.

[0255] In this implementation, the drug delivery system is modified by connecting a flow communication unit between the needle unit and the drug delivery device. This makes it possible to produce the same device for both cases where the drug contains preservatives and cases where it does not. In products where preservatives can be added without defects, the flow communication unit can be simply omitted.

[0256] The outlet surface can vary between connected and unconnected configurations. Figure 2C , 3C The connection structure is shown in 4C. Figure 2A , 2B Unconnected configurations are shown in 3A, 3B, 4A, and 4B. When connected to a flow guiding device, the connected configuration is defined as the assumed configuration of the outlet surface. In the connected configuration, the outlet surface allows connection between the flow communication unit and the flow guiding device, and the outlet surface is adapted to interface with the flow guiding device 230. Figure 2CA flow communication unit connected to the flow guiding device via connector 236 on the flow guiding device is schematically shown, as well as a corresponding connector on the flow communication unit or drug delivery device, not shown in the figures. Connector 236 can be a threaded or bayonet connector. Thus, the outlet surface allows connection by adapting it to interface with the inlet surface of the flow guiding device without obstructing or hindering contact between the connectors. Therefore, the shape or form of the outlet surface in the connected configuration can be observed in the assembled state, where the flow guiding device is connected to the flow guiding device. The flow communication unit in the connected configuration can also be observed by manipulating the outer surface in a manner similar to manipulating the connected flow guiding device. For some embodiments, the shape of the outlet surface in the connected configuration is close to that in the unconnected configuration, and for other embodiments, the difference in shape is clearly visible, i.e., the shape is significantly modified during connection. This aspect will be discussed later. In the unconnected configuration, the outlet surface is adapted to reduce contaminant entry into the internal space 245 of the flow communication unit. This particular modification is not shown in Figures 2 to 4, but can be embodied as a barrier covering the channel outlet, as will be explained in detail later. The unconnected structure of the outlet surface is defined as the actual structure when the flow communication unit and the flow guiding device are not connected, and it also includes the actual structure obtained in response to disconnecting the flow communication unit from the flow guiding device. Therefore, the shape of the outlet surface in the unconnected structure can be observed when the flow communication unit and the flow guiding device are not connected. The shape of the outlet surface in the unconnected structure can be easily examined, while the shape in the connected structure can be estimated or imagined by comparing the shape of the inlet surface of the flow guiding device and considering how the inlet surface interacts with the outlet surface when connected. A direct method to observe the shape of the outlet surface in the connected structure is to connect the flow communication unit to the transparent flow guiding device. The outlet surface can then be examined through the flow guiding device.

[0257] The flow communication unit also includes intermediate surfaces 243 and 244 extending between the inlet surface and the outlet surface. When the outlet surface is in a connected configuration and when it is in a non-connected configuration, the inlet surface, outlet surface, and intermediate surfaces define the outer surface and limit the internal space 245 of the flow communication unit.

[0258] The flow communication unit also includes an outlet sealing member 246, which in Figure 2C , 3C The dashed rectangles in 4C represent only approximate locations of the features. For outlet surfaces in a connected configuration, the outlet seal provides a portion of the outlet surface, and because the outlet surface can be modified, this allows for some variation in the position of the outlet seal, which is better illustrated in Figures 5 through 12 and will be explained later.

[0259] When the outlet surface is in a connected configuration, the outlet sealing member provides a portion of the outlet surface 242. That is, the outlet sealing member can be identified on the outlet surface when the flow communication unit is connected to the flow guiding unit, or when the outlet surface has been otherwise manipulated into a connected configuration.

[0260] The outlet sealing member 246 is adapted to contact the flow guiding device to establish a tight fluid channel seal 260, thereby providing tight fluid contact with the flow guiding device, which allows for leak-free communication between the flow communication unit and the fluid guiding device. The channel seal 260 is also indicated by a dashed rectangle, as its location can vary depending on the specific implementation. This aspect will be described in more detail with reference to Figures 5 through 12.

[0261] The flow communication unit also includes a first flow channel 247, which includes channel inlets 248, 348, and 448 adapted to provide flow communication with a drug delivery device, and a channel outlet 249 adapted to provide flow communication with a flow guiding device. The channel outlet 249 is located in... Figure 2C , 3C In 4C, the dashed rectangle indicates that this is only the approximate location of the feature.

[0262] The flow communication unit also includes a first outlet valve component, which is not shown in Figures 2 to 4, but will be described in further detail with reference to Figures 5 to 12.

[0263] The flow communication unit also includes an outlet barrier 250, which includes a second outlet valve member adapted to mate with the first outlet valve member. The outlet barrier 250 provides a portion of the outlet surface 242, and the barrier 250 is shown as a dashed rectangle in Figures 2 to 4 because its position can vary. The outlet barrier is configured in: (i) a closed configuration, and (ii) a flow configuration.

[0264] When the outlet barrier is in a closed configuration, this means that the outlet surface is in an unconnected configuration, and the second outlet valve component is adapted to mate with the first outlet valve component to provide an outlet barrier seal 253 (as shown by the dashed rectangle in Figures 2 to 4). Furthermore, the outlet barrier seal is adapted to reduce contaminants entering the first channel through the channel outlet.

[0265] When the outlet barrier is in the flow configuration, this means that the outlet surface is in the connection configuration, and the second outlet valve member is adapted to cooperate with the first outlet valve member to allow the drug contained in the first channel 247 to flow downstream from the channel inlet and out of the channel outlet 249 in response to the pressure in the first channel 247 being higher than a first threshold.

[0266] In addition to adapting to the outlet surface, the flow communication unit is also suitable for: (i) unconnected configuration and (ii) connected configuration.

[0267] In response to disconnecting the flow communication unit from the flow guiding device, the flow communication unit can be provided in an unconnected configuration, whereby the outlet surface will be in an unconnected configuration and the outlet barrier will be in a closed configuration. When the communication unit is in an unconnected configuration, the outlet surface reduces the volume of contaminants entering the internal volume, and the sealed outlet barrier particularly reduces the entry of contaminants into the channel outlet and further into the first channel and the reservoir.

[0268] A connection configuration of the flow communication unit can be provided in response to connecting the flow communication unit to the flow guiding device 230, whereby the outlet surface is in the connection configuration and the outlet barrier is in the flow configuration. In this configuration, the outlet sealing member 246 is arranged to contact the flow guiding device to provide a channel seal 260 downstream of the channel outlet 249 of the first flow channel. The flow communication unit is thus adapted to allow flow communication between the channel outlet 249 and the flow guiding device, and the channel outlet 249 is disposed at the outlet surface 242 of the flow communication unit. Since the outlet sealing member provides a portion of the outlet surface, and since this portion is disposed downstream of the channel outlet disposed on the outlet surface, the flow communication unit is adapted to connect to the flow guiding device without entering the internal volume of the flow communication unit. An example of a flow guiding device that enters the internal volume of a drug delivery device is a conventional pen needle with a proximal puncture needle adapted to penetrate a membrane covering a drug reservoir outlet.

[0269] By transforming flow connectivity into a connection configuration, a combined flow channel 267 can be provided between the drug delivery device 210, the first flow channel 247, and the flow guide device 230, in response to the channel inlet being arranged in flow connectivity with the drug delivery device and in response to the flow connectivity unit 240 being connected to the flow guide device and a channel seal being arranged downstream of the channel outlet.

[0270] Thus, the flow communication unit 240 is adapted to enable the long-term use of the reusable drug delivery device without damaging or removing the closure of the multi-dose drug delivery device, and thus, the flow communication unit is adapted to inhibit the entry of microorganisms into the reusable drug delivery device during long-term use.

[0271] Flow guiding device A flow guiding device 230 for guiding a drug from a flow communication unit includes: a first connector 236 adapted to connect the flow guiding device 230 to a flow communication unit 240; and an inlet surface 231 for interfacing with and contacting an outlet surface 242 of the flow communication unit 240. The inlet surface 231 provides an outer surface for the flow guiding device 230.

[0272] The flow guiding device also includes an inlet seal 232 that provides a portion of an inlet surface 231 and is adapted to contact an outlet seal 246 of the flow communication unit 240. The inlet seal is adapted to provide a tight fluid seal at the interface between the flow guiding device and the flow communication unit.

[0273] The flow guiding device also includes a second channel 237 for guiding fluid, the second channel having a channel inlet 238 and a channel outlet 239 located at an inlet surface 231.

[0274] The flow guiding device can be in the form of a pen needle including a needle hub and a needle cannula, or in the form of an infusion set including a needle hub and a catheter.

[0275] Drug delivery system The drug delivery system is adapted to be assembled into a connection configuration in which a flow communication unit is located and connected to a flow guiding device 230. This brings the outlet seal portion 246 and the inlet seal portion 232 into contact to provide a tight fluid passage seal 260 in the interface between the flow communication unit and the flow guiding device.

[0276] The inlet 248 of the first channel 247 is arranged to flow in communication with the outlet 212 of the storage tank, and the outlet 249 of the first channel 247 is arranged to flow in communication with the inlet 238 of the second channel 237, thereby providing a combined flow channel 267 between the storage tank, the first channel and the second channel.

[0277] The channel seal 260 surrounds and provides a portion of the combined flow channel, wherein the combined flow channel defines a defined volume through which a defined amount of drug can be delivered to a subject. The combined flow channel includes an inner surface adapted to directly contact the drug flowing in the combined flow channel, and the channel seal is also adapted to directly contact the drug flowing in the combined flow channel.

[0278] To limit backflow from the flow guiding device to the reservoir, when the flow communication unit is in the connected configuration and in response to a pressure in the second channel being greater than the pressure in the first channel, the system may further include a one-way valve 270 positioned along the combined flow channels. The one-way valve is adapted to allow flow from the reservoir to the flow guiding device in response to the reservoir 213 being pressurized, thereby propagating pressure from the reservoir to the first and second channels. Alternatively, backflow or reverse flow can be prevented by controlling a pressure mechanism. The reservoir may be (i) in a pressurized state, where the pressure mechanism pressurizes the liquid drug, and (ii) in a depressurized state. A depressurized state is defined as a state in which the pressure mechanism does not pressurize the liquid drug, and the pressure of the drug is the same as the pressure outside the reservoir, i.e., atmospheric pressure or the pressure of the surrounding environment. In both states, the pressure mechanism can prevent backflow into the reservoir because the pressure in the reservoir is equal to or higher than the pressure of the surrounding environment. Therefore, to prevent backflow, as described above, the injection device can operate in both pressurized and depressurized states.

[0279] The system may also include a housing adapted to: (i) cover a portion of the outer surface of the flow communication module, and (ii) maintain contact between the flow communication module and the drug delivery device. The housing may be in the form of a cover, an adapter top, or a code top.

[0280] Implementation plans in Figures 5 to 12 The embodiments shown in Figures 5 to 12 illustrate flow communication units 540, 640, 740, 840, 940, 1040, 1140, and 1240 for establishing flow communication from a reusable drug delivery device 210 suitable for long-term use to a flow guiding device 230. The drug delivery device 210 includes a reservoir containing multiple doses of a liquid drug formulation. In the event of accidental introduction of microorganisms into the reservoir during long-term use, or when microorganisms are introduced for testing purposes, the drug formulation will allow microbial growth. The reservoir is adapted to pressurize the liquid drug formulation, and the flow guiding device 230 is adapted to guide the drug to the subcutaneous tissue of a subject.

[0281] The flow communication unit includes an inlet surface 241 and an outlet surface 242 for interfacing with the drug delivery device 210. The outlet surface is configured in both a connected configuration and a disconnected configuration. In the connected configuration, the outlet surface allows the flow communication unit and the flow guiding device to be connected. The outlet surface is adapted to interface with the flow guiding device 230, thereby ensuring no physical obstruction when the two surfaces mate. In the disconnected configuration, the outlet surface allows the flow communication unit and the flow guiding device to be disconnected. The outlet surface is adapted to reduce contaminant ingress into the internal space 245 of the flow communication unit, thereby ensuring that the flow communication unit can be safely stored—separately from or connected / integrated with the drug delivery device—without allowing contaminants to enter through the outlet surface.

[0282] The flow communication unit also includes intermediate surfaces 243 and 244 extending between the inlet surface and the outlet surface. The inlet surface, outlet surface, and intermediate surfaces define an outer surface and limit the internal space 245 of the flow communication unit. The shape of the outer surface can be different depending on which of the two different configurations the outlet surface is constructed in, in which the outlet surface provides a portion of the outer surface.

[0283] The flow communication unit also includes outlet sealing members 546, 646, 746, 846, 946, 1046, 1146, and 1246, which, when the outlet surface is a connecting configuration, provide a portion of the outlet surface 242. The outlet sealing members 546, 646, 746, 846, 946, 1046, 1146, and 1246 are adapted to contact the flow guiding device to establish a tight fluid passage seal 560, 660, 760, 860, 960, 1060, 1160, and 1260. Therefore, the sealing member must be located on an outer surface. Otherwise, contact with another surface would be impossible. The outlet sealing member is adapted to provide tight fluid contact with the flow guiding device.

[0284] The flow communication unit further includes a first flow channel 247, which includes: channel inlets 348, 448, 548, 648, 748, 948, 1048, 1148, and 1248, the channel inlets being adapted to provide flow communication with a drug delivery device; and channel outlets 549, 649, 749, 849, 949, 1049, 1149, and 1249, the channel outlets being adapted to provide flow communication with a flow guiding device.

[0285] The flow communication unit also includes first outlet valve components 554, 654, 754, 854, 954, 1054, 1154, and 1254, and outlet barriers 550, 650, 750, 850, 950, 1050, 1150, and 1250. The outlet barriers include second outlet valve components 555, 655, 755, 855, 955, 1055, 1155, and 1255, adapted to mate with the first outlet valve components 554, 654, 754, 854, 954, 1054, 1154, and 1254. The outlet barriers 550, 650, 750, 850, 950, 1050, 1150, and 1250 also provide a portion of an outlet surface 242. Whether the outlet surface is in a connected or unconnected configuration, the outlet barriers provide a portion of the outer surface of the flow communication unit.

[0286] The outlet barrier is constructed in both a closed structure and a flow structure. The closed structure is... Figure 5D , 6C The flow structure is shown in 7C, 8C, 9C, 10C, 11D and 12E, and the flow structure is... Figure 5E, 6D As shown in 7D, 8D, 9D, 10D, 11E and 12F.

[0287] In the closed configuration, when the flow communication unit is not manipulated, for example, when the flow communication unit is not manipulated into a flow configuration during connection by a flow guiding device, the outlet barrier is closed and is in its normal configuration. When the outlet barrier is in the closed configuration, the outlet surface is in an unconnected configuration, and the second outlet valve components 555, 655, 755, 855, 955, 1055, 1155, 1255 are adapted to cooperate with the first outlet valve components 554, 654, 754, 854, 954, 1054, 1154, 1254 to provide outlet barrier seals 253, 553, 653, 753, 853, 953, 1053, 1153, 1253. In the closed configuration, the outlet barrier seal is adapted to reduce the entry of contaminants into the first channel through the channel outlet.

[0288] In the flow configuration, the outlet surface is in a connected configuration. Second outlet valve components 555, 655, 755, 855, 955, 1055, 1155, 1255 are adapted to cooperate with first outlet valve components 554, 654, 754, 854, 954, 1054, 1154, 1254 to allow the drug contained in the first channel 247 to flow downstream from the channel inlet and out of the second channels 249, 549, 749, 849, 949, 1049, 1149, 1249 in response to a pressure in the first channel 247 exceeding a first threshold.

[0289] Flow-connected units are also suitable for both unconnected and connected structures. Closed structures are... Figure 5D , 6C The flow structure is shown in 7C, 8C, 9C, 10C, 11D and 12E, and the flow structure is... Figure 5E , 6D As shown in 7D, 8D, 9D, 10D, 11E and 12F.

[0290] An unconnected configuration can be obtained by disconnecting the flow communication unit from the flow guiding device. The flow communication unit is also configured to be in an unconnected configuration before the flow guiding device is connected to it. For a flow communication unit in an unconnected configuration, the outlet surface is unconnected and the outlet barrier is closed.

[0291] The connection configuration can be obtained in response to connecting the flow communication unit to the flow guide device 230, or only when the unit is connected to the flow guide device. In this configuration, the outlet surface is in the connection configuration and the outlet barrier is in the flow configuration, wherein the outlet sealing member is arranged to contact the flow guide device to provide a channel seal downstream of the channel outlets 549, 649, 749, 849, 949, 1049, 1149 in the first flow channel. Therefore, the flow communication unit in the connection configuration is adapted to allow flow communication between the channel outlets 549, 649, 749, 849, 949, 1049, 1149, 1249 and the flow guide device, wherein the channel outlets 549, 649, 749, 849, 949, 1049, 1149, 1249 are arranged at the outlet surface 242 of the flow communication unit.

[0292] The flow communication unit is adapted to provide a combined flow channel 267 between the drug delivery device 210, the first flow channel 247 and the flow guidance device 230 in response to the channel inlet being arranged in flow communication with the drug delivery device and the flow communication units 540, 640, 740, 840, 940, 1040, 1140, 1240 being connected to the flow guidance device, wherein a channel seal is arranged downstream of the channel outlet.

[0293] Thus, the flow communication units (540, 640, 740, 840, 940, 1040, 1140, 1240) are adapted to enable long-term use of the reusable drug delivery device without damaging or removing the flow communication unit or the closure of the multi-dose drug delivery device. In this way, the flow communication unit is adapted to inhibit the entry of microorganisms into the reusable drug delivery device during long-term use.

[0294] Channel Exit In some embodiments of the flow connectivity unit according to this disclosure, exit barriers 550, 650, 750, 850, and 950 provide channel exits 549, 649, 749, 849, and 949.

[0295] Outlet sealing components In some embodiments of the flow communication unit according to this disclosure, the outlet barriers 550, 650, 850, 950 provide outlet sealing members 546, 646, 846, 946.

[0296] one-way valve In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a one-way valve 270 arranged along the first channel 247. This valve is adapted to guide downstream flow and inhibit upstream flow toward the drug delivery device. Therefore, the forced one-way flow helps reduce contaminants entering the first channel through the channel outlet.

[0297] Refer to the implementation scheme in Figures 3, 4, 11, and 12—proximal puncture needle In some embodiments of the flow communication unit according to the present disclosure, the flow communication unit further includes proximal puncture needles 391, 491, 1191, 1291 extending from the inlet surface in an extension configuration, wherein the proximal needles include a proximal opening end providing a channel inlet 249.

[0298] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a proximal puncture needle actuator 492 adapted to change the proximal puncture needle from a retracted configuration to an extended configuration in response to connecting the flow communication unit to the flow guiding device.

[0299] Refer to the implementation schemes in Figures 5, 6, 7, 8, and 9—proximal valve components In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes proximal valve members 598, 698, 798, 898, and 998, which are adapted to allow flow from the inlet toward the outlet and to prevent backflow.

[0300] In some embodiments of the flow communication unit according to this disclosure, proximal valve members 598, 698, 798, 898, 998 provide a portion of inlet surface 241 for interfacing with a drug delivery device.

[0301] In some embodiments of the flow communication unit according to this disclosure, the proximal valve members 598, 698, 798, 898, 998 provide a portion of an intermediate surface 243, 244 extending between the inlet surface 241 and the outlet surface 242.

[0302] In some embodiments of the flow communication unit according to this disclosure, the portions of the intermediate surfaces 243, 244 are flexible and provide device sealing surfaces 598.1, 698.1, 798.1, 898.1, 998.1 to seal the drug delivery device 210.

[0303] Refer to the implementation scheme in Figures 5, 6, 7, and 8—proximal valve component In some embodiments of the flow communication unit according to this disclosure, the proximal valve component provides channel inlets 548, 648, 748, 848.

[0304] Refer to the implementation scheme in Figure 5—proximal support member In some embodiments of the flow communication unit according to the present disclosure, the flow communication unit further includes a proximal support member 597, which includes a proximal end 597.9 and a proximal portion 597.10 adapted to support a proximal valve member 598.

[0305] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 597 is rigid, and the proximal portion of the proximal support member 597 includes a surface portion defining a proximal valve seat 597.1 adapted to provide a proximal seat sealing surface 597.2. The proximal valve member 598 includes a surface portion adapted to provide a proximal valve sealing surface 598.2, and provides a proximal fluid tight seal 597.3 between the proximal valve sealing surface 598.2 and the proximal seat sealing surface 597.2.

[0306] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 597 is rigid and provides the proximal portion of the first channel 247.

[0307] In some embodiments of the flow communication unit according to this disclosure, a proximal portion of the first channel 247 provided by the proximal support member extends from the proximal end 597.9 of the proximal support member 597.

[0308] In some embodiments of the flow communication unit according to this disclosure, the proximal valve member 598 includes a surface portion that provides a portion of the inlet surface 241 for interfacing with the drug delivery device 210. The proximal valve member 598 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface 241.

[0309] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 540 includes a normally closed configuration, wherein the proximal valve member is in a normal configuration, thereby providing a tight proximal fluid seal 597.3.

[0310] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 597 includes an enlarged channel portion 597.4 adapted to receive a receiving portion 598.3 of the proximal valve member, which includes a proximal valve sealing surface 598.2. The flow communication unit 540 includes an open configuration, wherein, in a forced configuration for the proximal valve member, the enlarged channel portion 597.4 receives the receiving portion of the proximal valve member. In this configuration, a tight proximal fluid seal 597.3 is not provided, and flow can be directed through the valve.

[0311] In some embodiments of the flow communication unit according to this disclosure, the proximal support members 597, 697 further include support portions 597.5, 697.5, which are adapted to be supported by the drug delivery device 210, thereby providing support for the flow communication unit relative to the drug delivery device 210.

[0312] Refer to the implementation schemes in Figures 5 and 8. In some embodiments of the flow communication unit according to this disclosure, the distal support members 593, 893 include a distal end and a distal portion adapted to support the outlet barriers 550, 850, and wherein the distal support members further include barrier operating members 593.2, 893.2 adapted to cooperate with the outlet barriers to adjust the tightness of the outlet barrier seals 553, 853.

[0313] This can be achieved via outlet barriers 550, 850, which include actuator portions 550.2, 850.2 providing outlet sealing members 546, 846. The actuator portions are movably arranged between a first position and a second position relative to barrier operating members 593.2, 893.2, and are adapted to be configured in an unconnected configuration and a connected configuration.

[0314] In the unconnected configuration, the outlet barrier is in a closed configuration, wherein the closed configuration of the outlet barrier also includes actuator portions 550.2, 850.2 in a first position relative to barrier operating members 593.2, 893.2, whereby the second outlet valve members 555, 855 are adapted to cooperate with the first outlet valve members 554, 854 to provide outlet barrier seals 553, 853, which are adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlets 549, 849 in response to a pressure in the first channel 247 exceeding a second threshold. The second threshold defines the tightness of the outlet barrier seals 553, 853 in the unconnected configuration and is greater than the first threshold.

[0315] In the connection configuration, the outlet barrier is in a flow configuration, wherein the flow configuration of the outlet barrier also includes actuator portions 550.2, 850.2 in a second position relative to barrier operating members 593.2, 893.2, whereby the second outlet valve members 555, 855 are adapted to cooperate with the first outlet valve members 554, 854 to provide outlet barrier seals 553, 853, which are adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlets 549, 849 in response to a pressure in the first channel 247 exceeding a first threshold, wherein the first threshold defines the tightness of the outlet barrier seal in the connection configuration.

[0316] In some embodiments of the flow communication unit according to this disclosure, the actuator portion is adapted to be manipulated from a first position to a second position by a flow guiding device during connection.

[0317] In some embodiments of the flow connectivity unit according to this disclosure, the flow connectivity unit is also adapted to be in: (i) an unconnected configuration, wherein barrier seals 553, 853 are defined by a second threshold, and (ii) Connection construction, wherein barrier seals 553, 853 are defined by a first threshold.

[0318] Refer to the implementation scheme in Figure 5—intermediate valve component In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes an intermediate valve member 594.

[0319] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 597 includes a distal end 597.11 and a distal portion 597.12 adapted to support the intermediate valve member 594.

[0320] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 597 is rigid, and the distal portion 597.12 of the proximal support member 597 includes a surface portion that defines an intermediate valve seat 597.6 adapted to provide an intermediate seat sealing surface 597.7. The intermediate valve member 594 includes a surface portion adapted to provide an intermediate valve sealing surface 594.1. Therefore, an intermediate fluid tight seal 597.8 can be provided between the intermediate valve sealing surface 594.1 and the intermediate seat sealing surface 597.7.

[0321] In some embodiments of the flow communication unit according to this disclosure, the proximal portion of the first channel 247 provided by the proximal support member extends from the proximal end 597.9 to the distal end 597.11.

[0322] In some embodiments of the flow communication unit according to this disclosure, the intermediate valve member 594 includes a proximal surface portion for interfacing with the proximal support member 597, and wherein the intermediate valve member 594 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0323] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 540 further includes an intermediate valve member in a normal configuration and providing a tight seal 597.8 for the intermediate fluid.

[0324] Refer to the implementation scheme in Figure 5—far-side support member In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a distal support member 593.

[0325] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 is rigid and provides the distal portion of the first channel 247.

[0326] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 includes an enlarged channel portion 593.1 adapted to receive a portion of the flexible portion 594.2 of the intermediate valve member 594, wherein the flexible portion 594.2 of the intermediate valve member 594 includes an intermediate valve sealing surface 594.1. An open configuration of the flow communication unit 540 also includes the enlarged channel portion 593.1, which, in a forced configuration, receives a portion of the flexible portion of the intermediate valve member, wherein no intermediate fluid tight seal 597.3 is provided.

[0327] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 further includes a support portion adapted to be supported by the proximal support member, thereby providing stability to the flow communication unit.

[0328] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 and the proximal support member 597 are adapted to clamp a portion of the intermediate valve member 594. Thus, the clamped portion is fixed, while the unclamped portion is adapted to move between a normal configuration and a forced configuration.

[0329] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 further includes a support portion adapted to be supported by the drug delivery device 210, thereby providing support for the flow communication unit relative to the drug delivery device 210.

[0330] Refer to the implementation plan in Figure 5—export barrier In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 includes a distal end and a distal portion adapted to support the outlet barrier 550.

[0331] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 is rigid, and the distal portion of the distal support member 593 includes a surface portion defining a first outlet valve member 554 adapted to provide a seat sealing surface, wherein the outlet barrier 550 includes a surface portion defining a second outlet valve member 555 adapted to provide a valve sealing surface, and wherein an outlet barrier seal 553 can be provided between the valve sealing surface and the seat sealing surface.

[0332] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 550 includes a proximal surface portion for interface with the distal support member 593, and wherein the outlet barrier 550 is flexible and can change from a normal configuration to a forced configuration in response to pressure in the first channel 247 and on the proximal surface portion exceeding a first threshold.

[0333] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 540 further includes an outlet barrier in a normal configuration and providing an outlet barrier seal 553.

[0334] In some embodiments of the flow communication unit according to this disclosure, the flow guiding device 230 includes an enlarged channel inlet 238 adapted to receive a portion of a flexible portion 550.1 of an outlet barrier 550, wherein the flexible portion 550.1 of the outlet barrier 550 includes a valve sealing surface. An open configuration of the flow communication unit also includes the enlarged channel inlet 238 receiving a portion of the flexible portion 550.1 of the outlet barrier in a forced configuration, wherein an outlet barrier seal 553 is not provided.

[0335] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 550 provides an outlet sealing member 546.

[0336] In some embodiments of the flow communication unit according to this disclosure, the distal support member 593 includes a distal end and a distal portion adapted to support the outlet barrier 550, wherein - The distal support member also includes a spacer member 593.2, which is adapted to separate the supported outlet barrier from the distal support member, thereby providing space between the distal support member and the outlet barrier, and - Wherein the outlet barrier 550 includes an actuator portion 550.2 that provides an outlet sealing member 546 and is movably arranged between a first position and a second position relative to the spacer member 593.2, and is adapted to be configured to be in: (i) Unconnected configuration, wherein the outlet barrier is in a closed configuration, wherein the closed configuration of the outlet barrier further includes an actuator portion 550.2 in a first position relative to the spacer member 593.2, whereby the second outlet valve member 555 is adapted to cooperate with the first outlet valve member 554 to provide an outlet barrier seal 553, which is adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet 549 in response to a pressure in the first channel 247 exceeding a second threshold, wherein the second threshold defines the tightness of the outlet barrier seal 553 and is greater than the first threshold. (ii) A connection configuration in which the outlet barrier is in a flow configuration, wherein the flow configuration of the outlet barrier further includes an actuator portion 550.2 in a second position relative to the spacer member 593.2, whereby the second outlet valve member 555 is adapted to cooperate with the first outlet valve member 554 to provide an outlet barrier seal 553, the outlet barrier seal being adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet 549 in response to a pressure in the first channel 247 exceeding a first threshold, wherein the first threshold defines a first threshold for the outlet barrier seal.

[0337] Therefore, the actuator portion of the outlet sealing member 546 is also provided to be manipulated from a first position to a second position by a flow guiding device during connection.

[0338] Therefore, a flow connectivity unit is provided, wherein the flow connectivity unit is further adapted to be in the following position: (i) Unconnected construction, wherein the tightness of the barrier seal 553 is defined by a second threshold, and (ii) A connection structure in which the tightness of the barrier seal 553 is defined by a first threshold.

[0339] Thus, a flow communication unit is obtained that enables the long-term use of a multi-dose injection device containing a drug that itself does not prevent microbial growth, and this long-term use is achieved because the channel seal is arranged downstream of the outlet and because the outlet is located on the outer surface of such an outlet. In other words, the flow communication unit eliminates the problem that arises when a potentially contaminated part of the flow guiding device (e.g., a pen needle) penetrates the outer surface of the drug delivery device. If this occurs, there is a risk of contamination of the internal parts of the drug delivery device. Furthermore, when a part of the flow guiding device penetrates the outer surface, where a channel seal is formed between the penetrating guide device and the outer surface (e.g., a diaphragm), a vacuum is created in the drug delivery device when the flow guiding device is removed from it, and bodily fluids can subsequently be drawn into the drug delivery device. This effect is also eliminated or minimized when a channel seal is formed on the outer surface of the drug delivery device, i.e., when no part of the flow guiding device penetrates the outer surface.

[0340] Refer to the implementation plan in Figure 6—supporting components In some embodiments of the flow communication unit according to the present disclosure, the flow communication unit further includes a support member 697, which includes a proximal end 697.9 and a proximal portion 697.10 adapted to support a proximal valve member 698.

[0341] In some embodiments of the flow communication unit according to this disclosure, the support member 697 is rigid, and the proximal valve member 698 is a self-sufficient valve 698, which includes a first valve member having a surface portion adapted to provide a first proximal valve sealing surface. The proximal valve member also includes a second valve member having a surface portion adapted to provide a second proximal valve sealing surface. These two valve members are adapted to provide a tight proximal fluid seal 698.2 between the first and second proximal valve sealing surfaces.

[0342] In some embodiments of the flow communication unit according to this disclosure, the support member 697 is rigid, and the proximal portion of the support member 697 includes a proximal valve housing 697.1 adapted to receive a receiving portion 698.3 of a self-propelled valve 698.

[0343] In some embodiments of the flow communication unit according to this disclosure, support member 697 provides a portion of the first channel 247.

[0344] In some embodiments of the flow communication unit according to this disclosure, a portion of the first channel 247 provided by the support member 697 extends from the proximal end 697.9 of the support member 697.

[0345] In some embodiments of the flow communication unit according to this disclosure, the self-sufficient valve 698 includes a surface portion that provides a portion of an inlet surface 241 for interfacing with the drug delivery device 210, and the self-sufficient valve 698 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface 241.

[0346] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 640 includes a normally closed configuration, wherein the self-contained valve is in normal configuration, thereby providing a tight seal 698.2 for the proximal fluid.

[0347] In some embodiments of the flow communication unit according to this disclosure, the self-contained valve is in a forced configuration and does not provide a close seal for the proximal fluid 698.2.

[0348] In some embodiments of the flow communication unit according to this disclosure, the proximal valve housing 697.1 includes an enlarged channel portion adapted to receive a receiving portion 698.3, wherein the receiving portion of the self-sustaining valve includes a first proximal valve sealing surface and a second proximal valve sealing surface, wherein the receiving portion expands radially as the self-sustaining valve changes from a normal configuration to a forced configuration, and wherein the proximal valve housing is adapted to provide a stop for the radial expansion, thereby limiting the maximum expansion.

[0349] In some embodiments of the flow communication unit according to this disclosure, the support member 697 further includes a support portion 697.5 adapted to be supported by the drug delivery device 210, thereby providing support for the flow communication unit relative to the drug delivery device 210.

[0350] Refer to the implementation plan in Figure 6—export barrier In some embodiments of the flow communication unit according to this disclosure, the support member 697 includes a distal end 697.11 and a distal portion 697.12 adapted to support the outlet barrier 650.

[0351] In some embodiments of the flow communication unit according to this disclosure, the distal portion 697.12 includes a surface portion defining a first outlet valve member 654 adapted to provide a seat sealing surface, wherein the outlet barrier 650 includes a surface portion defining a second outlet valve member 655 adapted to provide a valve sealing surface, and wherein an outlet barrier seal 653 is capable of being provided between the valve sealing surface and the seat sealing surface.

[0352] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 650 includes a proximal surface portion for interface with the distal portion 697.12, and wherein the outlet barrier 650 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0353] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 640 further includes an outlet barrier in a normal configuration and providing an outlet barrier seal 653.

[0354] In some embodiments of the flow communication unit according to this disclosure, the flow guiding device 230 includes an enlarged channel inlet 238 adapted to receive a portion of the flexible portion 650.1 of the outlet barrier 650, wherein the flexible portion 650.1 of the outlet barrier 650 includes a valve sealing surface, wherein the opening configuration of the flow communication unit also includes the enlarged channel inlet 238 receiving a portion of the flexible portion 650.1 of the outlet barrier in a forced configuration, wherein an outlet barrier seal 653 is not provided.

[0355] Refer to the implementation scheme in Figure 7—proximal support member In some embodiments of the flow communication unit according to the present disclosure, the flow communication unit further includes a proximal support member 797, which includes a proximal end 797.9 and a proximal portion 797.10 adapted to support a proximal valve member 798.

[0356] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 797 is rigid, and the proximal valve member 798 is a self-sufficient valve 798, which includes a first valve member having a surface portion adapted to provide a first proximal valve sealing surface. The proximal valve member 798 also includes a second valve member having a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal 798.2 can be provided between the first and second proximal valve sealing surfaces.

[0357] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 797 is rigid, and the proximal valve member includes a skirt adapted to surround and securely engage the proximal portion 797.1 of the proximal support member 797.

[0358] In some embodiments of the flow communication unit according to this disclosure, the self-sufficient valve 798 includes a surface portion that provides a portion for interfacing with the inlet surface 241 of the drug delivery device 210, and wherein the self-sufficient valve 798 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface 241.

[0359] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 740 includes a normally closed configuration, wherein the self-contained valve is in normal configuration, thereby providing a tight seal 798.2 for the proximal fluid.

[0360] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 740 includes an open configuration in which the self-sufficient valve is in a forced configuration, and in which a proximal fluid tight seal 798.2 is not provided.

[0361] In some embodiments of the flow communication unit according to this disclosure, the proximal portion 797.1 of the proximal support member 797 includes an enlarged channel portion adapted to receive a portion of the flexible portion 798.3 of the self-sustaining valve 798, wherein the flexible portion includes a first proximal valve sealing surface and a portion of a second proximal valve sealing surface, wherein the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from a normal configuration to a forced configuration, and wherein the proximal portion 797.1 is adapted to provide a stop for the axial deflection, thereby limiting the maximum deflection.

[0362] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 797 further includes a support portion 797.5 adapted to be supported by the drug delivery device 210, thereby providing support for the flow communication unit relative to the drug delivery device 210.

[0363] Refer to the implementation scheme in Figure 7—proximal support member—distal section / exit barrier In some embodiments of the flow communication unit according to this disclosure, the proximal support member 797 includes a distal end 797.11 and a distal portion 797.12 adapted to support the outlet barrier 750.

[0364] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 797 is rigid, and the distal portion 797.12 of the proximal support member 797 includes a surface portion defining a first outlet valve member 754 adapted to provide a seat sealing surface, wherein the outlet barrier 750 includes a surface portion defining a second outlet valve member 755 adapted to provide a valve sealing surface, and wherein an outlet barrier seal 753 is capable of being provided between the valve sealing surface and the seat sealing surface.

[0365] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 750 includes an inner surface portion for interface with the distal portion 797.12 of the proximal support member 797, and wherein the outlet barrier 750 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0366] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 740 further includes an outlet barrier in a normal configuration and providing an outlet barrier seal 753.

[0367] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 797 provides the proximal portion of the first channel 247.

[0368] In some embodiments of the flow communication unit according to this disclosure, the proximal portion of the first channel 247 provided by the proximal support member 797 extends from the proximal end 797.9 to the intermediate position 797.13.

[0369] In some embodiments of the flow communication unit according to this disclosure, a distal portion of a first channel 247 is disposed in the space between a distal portion 797.12 and an outlet barrier 750, wherein the distal portion of the first channel extends from a central position 797.13 to an outlet 749.

[0370] Refer to the implementation scheme in Figure 7—intermediate valve component In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 750 provides an intermediate valve component 750.2.

[0371] In some embodiments of the flow communication unit according to this disclosure, the distal portion 797.12 of the proximal support member 797 is adapted to support the intermediate valve member 750.2.

[0372] In some embodiments of the flow communication unit according to this disclosure, the distal portion 797.12 of the proximal support member 797 includes a surface portion defining an intermediate valve seat 750.3 adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member 750.2 includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal can be provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0373] In some embodiments of the flow communication unit according to this disclosure, the intermediate valve member 750.2 includes an inner surface portion for interfacing with the proximal support member 797, and wherein the intermediate valve member 750.2 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0374] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 740 further includes an intermediate valve member in a normal configuration and providing a tight seal for the intermediate fluid.

[0375] In some embodiments of the flow communication unit according to this disclosure, an intermediate valve component is arranged in the distal portion of the first channel 247.

[0376] Refer to the implementation scheme in Figure 7—far-side support member In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a distal support member 793.

[0377] In some embodiments of the flow communication unit according to this disclosure, the distal support member 793 includes a tubular portion 793.1 adapted to receive a receiving portion of the outlet barrier 750, wherein the receiving portion expands radially as the outlet barrier 750 changes from a normal configuration to a forced configuration, and wherein the tubular portion 793.1 is adapted to provide a stop for the radial expansion, thereby limiting the maximum expansion.

[0378] In some embodiments of the flow communication unit according to this disclosure, the receiving portion of the outlet barrier 750 includes a second outlet valve member 755, wherein the opening configuration of the flow communication unit 740 also includes an outlet barrier in a forced configuration, and wherein an outlet barrier seal 753 is not provided.

[0379] In some embodiments of the flow communication unit according to this disclosure, the receiving portion of the outlet barrier 750 includes an intermediate valve member 750.2, wherein the opening configuration of the flow communication unit 740 also includes the outlet barrier in a forced configuration, and wherein no tight seal of the intermediate fluid is provided.

[0380] In some embodiments of the flow communication unit according to this disclosure, the distal support member 793 further includes a support portion adapted to be supported by the proximal support member, thereby providing stability to the flow communication unit.

[0381] Refer to the implementation scheme in Figure 7—distal sealing component In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a distal sealing member 794 that provides an outlet sealing member 746.

[0382] In some embodiments of the flow communication unit according to this disclosure, the distal support member 793 is adapted to support the distal sealing member 794.

[0383] Refer to the implementation scheme in Figure 8—proximal valve component In some embodiments of the flow communication unit according to this disclosure, the proximal valve member further includes a support portion adapted to be supported by the drug delivery device 210, thereby providing support for the flow communication unit relative to the drug delivery device 210.

[0384] In some embodiments of the flow communication unit according to this disclosure, a proximal valve member is adapted to be fitted into an adapter top 290 having a retaining member on its inner surface, wherein the proximal valve member includes a flat distal surface and a recess that is adapted to receive the retaining member when the proximal valve member is inserted into the adapter top 290, thereby keeping the distal surface flat to allow close contact with another flat surface.

[0385] Refer to the implementation scheme in Figure 8—proximal support component In some embodiments of the flow communication unit according to the present disclosure, the flow communication unit further includes a proximal support member 897, which includes a proximal end 897.9 and a proximal portion 897.10 adapted to support a proximal valve member 898.

[0386] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 is rigid, and the proximal valve member 898 is a self-contained valve 898 comprising a first valve member including a surface portion adapted to provide a first proximal valve sealing surface, and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal 898.2 can be provided between the first and second proximal valve sealing surfaces.

[0387] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 is rigid and has a flat proximal surface, and the self-sustaining valve includes a substantially flat distal surface, and the proximal support member is adapted to transmit compressive force to the self-sustaining valve 898, and the self-sustaining valve is adapted to transmit compressive force to the drug delivery device.

[0388] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 is rigid, and wherein the proximal support member is adapted to be fitted into an adapter top 290 having a retaining member on its inner surface, and wherein the proximal support member includes a proximal surface adapted to be flattened, the flat proximal surface being supported by the retaining member, and thereby, when the proximal support member 897 and the self-sustaining valve 898 are inserted into the adapter top 290, the proximal surface can be held in close contact with the flat distal surface of the self-sustaining valve 898.

[0389] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 is rigid and provides the proximal portion of the first channel 247.

[0390] In some embodiments of the flow communication unit according to this disclosure, a proximal portion of the first channel 247 provided by the proximal support member 897 extends from the proximal end 897.9 of the proximal support member 897.

[0391] In some embodiments of the flow communication unit according to this disclosure, the self-sustaining valve 898 includes a surface portion that provides a portion for interfacing with the inlet surface 241 of the drug delivery device 210, and wherein the self-sustaining valve 898 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface 241.

[0392] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 840 includes a normally closed configuration, wherein the self-contained valve is in normal configuration, thereby providing a tight seal 898.2 for the proximal fluid.

[0393] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 840 includes an open configuration in which the self-sufficient valve is in a forced configuration, and in which a proximal fluid tight seal 898.2 is not provided.

[0394] In some embodiments of the flow communication unit according to this disclosure, the proximal portion 897.1 of the proximal support member 897 includes an enlarged channel portion adapted to receive a portion of the flexible portion 898.3 of the self-sustaining valve 898, wherein the flexible portion includes a portion of a first proximal valve sealing surface and a portion of a second proximal valve sealing surface, wherein in response to the self-sustaining valve changing from a normal configuration to a forced configuration, a portion of the flexible portion is axially deflected into the enlarged channel portion, and wherein the proximal portion 797.1 is adapted to provide a stop for the axial deflection, thereby limiting the maximum deflection.

[0395] Refer to the implementation scheme in Figure 8—intermediate valve component In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes an intermediate valve member 894.

[0396] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 includes a distal end 897.11 and a distal portion 897.12 adapted to support the intermediate valve member 894.

[0397] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 is rigid, and the distal portion 897.12 of the proximal support member 897 includes a surface portion defining an intermediate valve seat 897.6 adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member 894 includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal 897.8 can be provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0398] In some embodiments of the flow communication unit according to this disclosure, the proximal portion of the first channel 247 extends from the proximal end 897.9 to the distal end 897.11.

[0399] In some embodiments of the flow communication unit according to this disclosure, the intermediate valve member 894 includes a proximal surface portion for interfacing with the distal portion of the proximal support member 897, and wherein the intermediate valve member 894 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0400] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 840 further includes an intermediate valve member in a normal configuration and providing a tight seal 897.8 for the intermediate fluid.

[0401] Refer to the implementation scheme in Figure 8—far-side support member In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a distal support member 893.

[0402] In some embodiments of the flow communication unit according to this disclosure, the distal support member 893 is rigid and provides the distal portion of the first channel 247.

[0403] In some embodiments of the flow communication unit according to this disclosure, the distal support member 893 includes an enlarged channel portion 893.1 adapted to receive a portion of the flexible portion 894.2 of the intermediate valve member 894, wherein the flexible portion 894.2 of the intermediate valve member 894 includes an intermediate valve sealing surface 894.1, wherein the open configuration of the flow communication unit 840 also includes the enlarged channel portion 893.1, which receives a portion of the flexible portion of the intermediate valve member in a forced configuration, wherein no intermediate fluid tight seal 897.3 is provided.

[0404] In some embodiments of the flow communication unit according to this disclosure, a proximal support member 897, an intermediate valve member 894, and a distal support member 893 are provided as a unit, wherein a portion of the intermediate valve member is clamped between the support members, and wherein the support members are ultrasonically welded together.

[0405] In some embodiments of the flow communication unit according to this disclosure, the clamped portion is fixed, while the unclamped portion is flexible and adapted to move between a normal configuration and a forced configuration.

[0406] Refer to the implementation plan in Figure 8—export barrier In some embodiments of the flow communication unit according to this disclosure, the distal support member 893 includes a distal end and a distal portion adapted to support the outlet barrier 850.

[0407] In some embodiments of the flow communication unit according to this disclosure, the distal support member 893 is rigid, and the outlet barrier 850 is a self-sufficient valve 850, the self-sufficient valve comprising: a first valve member 854 including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member 855 including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal 853 can be provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0408] In some embodiments of the flow communication unit according to this disclosure, the self-sustaining valve 850 includes a proximal surface portion for covering the first channel 247, and wherein the self-sustaining valve 850 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure in the first channel and on the proximal surface portion of the self-sustaining valve.

[0409] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 840 includes a self-contained valve in normal configuration, thereby providing a tight seal 853 for the proximal fluid.

[0410] In some embodiments of the flow communication unit according to this disclosure, the opening configuration of the flow communication unit 840 includes a self-contained valve in a forced configuration, and wherein a proximal fluid tight seal 853 is not provided.

[0411] In some embodiments of the flow communication unit according to this disclosure, the proximal portion 897.1 of the proximal support member 897 includes an enlarged channel portion adapted to receive a portion of the flexible portion 898.3 of the self-sustaining valve 898, wherein the flexible portion includes a portion of a first proximal valve sealing surface and a portion of a second proximal valve sealing surface, wherein in response to the self-sustaining valve changing from a normal configuration to a forced configuration, a portion of the flexible portion is axially deflected into the enlarged channel portion, and wherein the proximal portion 897.1 is adapted to provide a stop for the axial deflection, thereby limiting the maximum deflection.

[0412] In some embodiments of the flow communication unit according to this disclosure, the distal support member 893 is rigid and has a flat distal surface, and the self-sufficient valve includes a substantially flat proximal surface, and the distal support member is adapted to transmit compressive force to the outlet barrier 850, and the outlet barrier is adapted to transmit compressive force to the adapter top 290.

[0413] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 897 is rigid, and wherein the proximal support member, intermediate valve member, distal support member, and outlet barrier are adapted to be fitted into an adapter top 290 having a retaining member on its inner surface, and wherein the proximal support member includes a flat proximal surface adapted to be supported by the retaining member, such that when all members are inserted into the adapter top 290, the proximal surface can be held in close contact with the flat distal surface of the proximal valve member 898.

[0414] In some embodiments of the flow communication unit according to this disclosure, a unit is provided by a proximal support member 897, an intermediate valve member 894, and a distal support member 893, wherein a portion of the intermediate valve member is clamped between the support members, and wherein the unit is adapted to be fitted into an adapter top 290 having a unit holding member adapted to hold the unit in a compressed state.

[0415] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier and the unit are adapted to be held in the top of the adapter in a compressed state, wherein the holding member can transmit the compressive force to the unit, and the unit can transmit the compressive force to the holding surface of the top 290 of the adapter.

[0416] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier and the unit are adapted to be held in an adapter top in a compressed state, wherein the proximal valve member is adapted to be fitted into the adapter top in a compressed state, and wherein the adapter top includes a device retaining member on its inner surface, wherein the device retaining member is adapted to connect the adapter top to a drug retaining device, wherein the proximal valve member is supported by a drug delivery device in a compressed state.

[0417] In some embodiments of the flow communication unit according to this disclosure, the flow guiding device 230 includes an enlarged channel inlet 238 adapted to receive a portion of the flexible portion 850.1 of the self-sustaining valve 850, wherein the flexible portion 850.1 of the self-sustaining valve 850 includes a portion of the outlet barrier seal 853, wherein the opening configuration of the flow communication unit also includes the enlarged channel inlet 238 receiving a portion of the flexible portion 850.1 of the outlet barrier in a forced configuration, wherein the outlet barrier seal 853 is not provided.

[0418] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 850 provides an outlet sealing member 846.

[0419] On the other hand, the flow guiding device includes a sealing member adapted to cooperate with an outlet sealing member disposed on the outlet barrier.

[0420] On the other hand, the outlet barrier is stretched by the sealing members of the flow guiding device, wherein the first outlet sealing member and the second outlet sealing member are pulled apart from each other (by... Figure 8D Arrow 896 in the figure indicates that this reduces the strength of the fluid tight outlet seal.

[0421] On the other hand, the outlet barrier in the closed configuration also includes, as the outlet barrier is stretched in the closed configuration, the outlet barrier is adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet in response to the pressure in the first channel being higher than a second threshold, wherein the second threshold is greater than the first threshold.

[0422] In some embodiments of the flow communication unit according to this disclosure, the distal support member 893 includes a distal end and a distal portion adapted to support the outlet barrier 850, wherein - The distal support member also includes a spacer member 893.2, which is adapted to separate the supported outlet barrier from the distal support member, thereby providing space between the distal support member and the outlet barrier, and - Wherein the outlet barrier 850 includes an actuator portion 850.2 that provides an outlet sealing member 846 and is movably arranged between a first position and a second position relative to the spacer member 893.2, and is adapted to be configured to be in: (i) An unconnected configuration in which the outlet barrier is in a closed configuration, wherein the closed configuration of the outlet barrier further includes an actuator portion 850.2 in a first position relative to the spacer member 893.2, whereby the second outlet valve member 855 is adapted to cooperate with the first outlet valve member 854 to provide an outlet barrier seal 853, which is adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet 849 in response to a pressure in the first channel 247 exceeding a second threshold, wherein the second threshold defines the tightness of the outlet barrier seal 853 and is greater than the first threshold. (ii) A connection configuration in which the outlet barrier is in a flow configuration, wherein the flow configuration of the outlet barrier further includes an actuator portion 850.2 in a second position relative to the spacer member 893.2, whereby the second outlet valve member 855 is adapted to cooperate with the first outlet valve member 854 to provide an outlet barrier seal 853, the outlet barrier seal being adapted to allow the drug contained in the first channel to flow downstream from the channel inlet and out of the channel outlet 849 in response to a pressure in the first channel 247 exceeding a first threshold, wherein the first threshold defines a first threshold for the outlet barrier seal.

[0423] Therefore, the actuator portion of the outlet sealing member 846 is also provided to be manipulated from a first position to a second position by a flow guiding device during connection.

[0424] Therefore, a flow connectivity unit is provided, wherein the flow connectivity unit is further adapted to be in the following position: (i) Unconnected construction, wherein the tightness of the barrier seal 853 is defined by a second threshold, and (ii) A connection structure in which the tightness of the barrier seal 853 is limited by a first threshold.

[0425] Refer to the implementation scheme in Figure 9—proximal valve component In some embodiments of the flow communication unit according to this disclosure, the proximal valve member 998 provides a channel inlet 948 in a normal configuration, wherein the valve is closed.

[0426] In some embodiments of the flow communication unit according to this disclosure, the proximal valve member provides a passageway in a forced configuration, wherein the valve is open.

[0427] In some embodiments of the flow communication unit according to this disclosure, the proximal valve member includes a distal surface portion for interfacing with the movable channel member, and wherein the proximal valve member 998 is flexible and can change from a normal configuration to a forced configuration in response to pressure exerted by the movable channel member on the distal surface portion.

[0428] Refer to the implementation scheme in Figure 9—proximal support member In some embodiments of the flow communication unit according to the present disclosure, the flow communication unit further includes a proximal support member 997, which includes a proximal end 997.9 and a proximal portion 997.10 adapted to support a proximal valve member 998.

[0429] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 997 is rigid, wherein the proximal valve member 998 is a self-sufficient valve 998, the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal 998.2 can be provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0430] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 997 is rigid, and the self-sustaining valve 998 includes a skirt adapted to surround and / or be surrounded by the proximal portion 997.1 of the proximal support member 997, thereby fixing the self-sustaining valve and the proximal support member together.

[0431] In some embodiments of the flow communication unit according to this disclosure, the self-sustaining valve 998 includes: a proximal surface portion that provides a portion of an inlet surface 241 for interfacing with a drug delivery device 210; and a distal surface portion for interfacing with a movable channel member. The self-sustaining valve 998 is flexible, and (i) the self-sustaining valve can change from a normal configuration to a forced configuration in response to pressure exerted on the distal surface portion by the movable channel member, and (ii) the movable channel member supports the self-sustaining valve 998 in the normal configuration in response to fluid pressure on the inlet surface 241, thereby maintaining a tight fluid seal 998.2.

[0432] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 940 includes a normally closed configuration, wherein the self-contained valve is in normal configuration, thereby providing a tight seal 998.2 for the proximal fluid.

[0433] In some embodiments of the flow communication unit according to this disclosure, the flow communication unit 940 includes an open configuration in which the self-sufficient valve is in a forced configuration, and a channel inlet 948 is provided by a movable channel member, and wherein a proximal fluid tight seal 998.2 is not provided.

[0434] In some embodiments of the flow communication unit according to this disclosure, the proximal portion 997.1 of the proximal support member 997 is adapted to receive a portion of the self-sustaining valve 998, wherein the received portion of the self-sustaining valve defines a channel seat portion, wherein the channel seat portion is adapted to provide a seat for the proximal portion of the movable channel member in a distal position, and wherein the self-sustaining valve is in a forced configuration.

[0435] In some embodiments of the flow communication unit according to this disclosure, the proximal portion 997.1 of the proximal support member 997 is adapted to receive a portion of the defined channel seat portion of the self-sustaining valve 998, wherein the channel seat portion is adapted to provide a seat for the distal portion of the movable channel member in a proximal position, wherein the movable channel member extends across the self-sustaining valve 998, wherein the self-sustaining valve 998 provides a seal around the movable channel member, and wherein the self-sustaining valve is in a forced configuration.

[0436] In some embodiments of the flow communication unit according to this disclosure, the proximal support member 997 further includes a support portion 997.5 adapted to be supported by the drug delivery device 210, thereby providing support for the flow communication unit relative to the drug delivery device 210.

[0437] Referring to the implementation scheme in Figure 9—proximal support member—distal portion In some embodiments of the flow communication unit according to this disclosure, the proximal support member 997 includes a distal end 997.11 and a distal portion 997.12 adapted to support the outlet barrier 750.

[0438] Refer to the implementation scheme in Figure 9—far-side support member In some embodiments of the flow communication unit according to this disclosure, the flow communication unit further includes a distal support member 993.

[0439] In some embodiments of the flow communication unit according to the present disclosure, the proximal support member 997 includes a tubular portion adapted to receive the distal support member 993, wherein the distal support member 993 is movably arranged within the tubular portion, and wherein the distal support member is adapted to move between a distal position and a proximal position.

[0440] In some embodiments of the flow communication unit according to this disclosure, the distal support member 993 includes a proximal end portion 993.9 and a proximal portion 993.10, the proximal portion including a movable channel member.

[0441] In some embodiments of the flow communication unit according to this disclosure, the distal support member 993 includes a distal end 993.11 and a distal portion 993.12 adapted to support the outlet barrier 950.

[0442] In some embodiments of the flow communication unit according to this disclosure, the distal support member 993 is rigid, and wherein the distal portion 993.12 of the distal support member 993 includes a surface portion defining a first outlet valve member 954 adapted to provide a seat sealing surface, wherein the outlet barrier 950 includes a surface portion defining a second outlet valve member 955 adapted to provide a valve sealing surface, and wherein an outlet barrier seal 953 is capable of being provided between the valve sealing surface and the seat sealing surface.

[0443] In some embodiments of the flow communication unit according to this disclosure, the outlet barrier (950) includes an inner surface portion for interface with the distal portion (993.12) of the distal support member (993), and wherein the outlet barrier (950) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0444] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 940 further includes an outlet barrier in a normal configuration and providing an outlet barrier seal 953.

[0445] In some embodiments of the flow communication unit according to this disclosure, the proximal portion 993.10 of the distal support member 993 provides the proximal portion of the first channel 247.

[0446] In some embodiments of the flow communication unit according to this disclosure, the proximal portion of the first channel 247 provided by the distal support member 993 extends from the proximal end 993.9 to the intermediate position 993.13.

[0447] In some embodiments of the flow communication unit according to this disclosure, a distal portion of the first channel 247 is disposed between a distal portion 993.12 and an outlet barrier 950, and wherein the distal portion of the first channel extends from an intermediate position 997.13 to an outlet 949.

[0448] In some embodiments of the flow communication unit according to this disclosure, the flow communication includes a biasing member 994 adapted to bias the distal support member 993 toward a distal position.

[0449] In some embodiments of the flow communication unit according to this disclosure, the biasing member 994 is located between the distal surface of the proximal support member 998 and the proximal surface of the distal support member 993.

[0450] In some embodiments of the flow communication unit according to this disclosure, the biasing member 994 is a compression spring.

[0451] Refer to the implementation scheme in Figure 9—intermediate valve component In some embodiments of the flow communication unit according to this disclosure, the outlet barrier 950 provides an intermediate valve component 950.2.

[0452] In some embodiments of the flow communication unit according to this disclosure, the distal portion 993.12 of the distal support member 993 is adapted to support the intermediate valve member 950.2.

[0453] In some embodiments of the flow communication unit according to this disclosure, the distal portion 993.12 of the distal support member 993 includes a surface portion defining an intermediate valve seat 993.14 adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member 950.2 includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal can be provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0454] In some embodiments of the flow communication unit according to this disclosure, the intermediate valve member 950.2 includes an inner surface portion for engaging with the distal support member 993, and wherein the intermediate valve member 950.2 is flexible and can change from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0455] In some embodiments of the flow communication unit according to this disclosure, the normally closed configuration of the flow communication unit 940 further includes an intermediate valve member in a normal configuration and providing a tight seal for the intermediate fluid.

[0456] In some embodiments of the flow communication unit according to this disclosure, the intermediate valve component is located in the distal portion of the first channel (247) and provides additional security.

[0457] Refer to the implementation plan in Figure 9—export barrier In some embodiments of the flow communication unit according to this disclosure, the outlet sealing member 946 is provided by the outlet barrier 950.

[0458] Refer to the implementation schemes in Figures 10, 11, and 12. In some embodiments of the flow communication unit 1040, 1140, 1240 according to the present disclosure, the flow communication unit further includes a central portion 1198, 1298 extending from the inlet surface 241 to the outlet surface 242, wherein the central portion provides a portion of the inlet surface and the outlet surface, and wherein the central portion includes a first flow channel 247, and the central portion also includes a side surface extending in one direction between the inlet surface and the outlet surface 242, wherein the channel outlet 1049, 1149 and the first outlet valve member 1054, 1154, 1254 are disposed in the side surface, and wherein the first outlet valve member surrounds the channel outlet 1049, 1149, 1249.

[0459] The outlet barriers 1050, 1150, and 1250 surround the central portion and provide a second outlet valve component 1055, 1155, and 1255, and the outlet barriers 1050, 1150, and 1250 are movably arranged and can move between a distal position and a proximal position.

[0460] When the outlet barriers 1050, 1150, and 12050 are located in the proximal position, the outlet surface 242 can be arranged in a connected configuration, while when the outlet barriers 1050, 1150, and 1250 are located in the distal position, the outlet surface 242 can be arranged in a non-connected configuration.

[0461] The circumferential portions 1197, 1297 connected to the central portion provide intermediate surfaces 243, 244 extending between the inlet surface and the outlet surface, and wherein the circumferential portions include a portion of the inlet surface and the outlet surface.

[0462] For the outlet surface 242 in either a connected or unconnected configuration, the inlet surface, outlet surface, and intermediate surface define an outer surface and restrict the internal space 245 of the flow communication unit, wherein the outlet barrier is located on the proximal or distal side.

[0463] The outlet sealing members 1046, 1146, and 1246 are disposed in the side surface of the central portion, and the outlet sealing members surround the channel outlets 1049, 1149, and 1249, thereby providing a portion of the outlet surface 242 in the connection structure.

[0464] The outlet barriers 1050, 1150, and 1250 provide a portion of the outlet surface 242, wherein when the outlet surface is in an unconnected configuration, the outlet surface provided by the outlet barrier is flush with the outlet portion provided by the central portion and the circumferential portion, thereby making it easier to keep the outlet surface clean.

[0465] In addition, the outlet barriers 1050, 1150, and 1250 provide a portion of the outlet surface 242, wherein when the outlet surface is in the connection configuration, the outlet surface provided by the outlet barrier is partially recessed relative to the outlet surface provided by the central portion and the circumferential portion.

[0466] The second outlet valve components 1055, 1155, 1255 are adapted to mate with the first outlet valve components 1054, 1154 to provide outlet barrier seals 1053, 1153, 1253, wherein the outlet barrier is adapted to be in the following position: (i) A closed configuration, wherein the outlet surface is in the unconnected configuration, whereby the outlet barrier is in the distal position, and whereby the outlet barrier seal is adapted to reduce the entry of contaminants, and (ii) A flow configuration wherein the outlet surface is located in the connection configuration, thereby the outlet barrier is located in the proximal position, thereby the outlet barriers 1050, 1150, 1250 are adapted to allow the drug contained in the first channel 247 to flow downstream from the channel inlet and out from the channel outlet 1049, 1149, 1249 in response to a pressure in the first channel 247 exceeding the first threshold.

[0467] The fluid communication unit is also adapted to be in: (i) An unconnected configuration that responds to disconnecting the flow communication unit from the flow guiding device—and wherein outlet barriers 1050, 1150, 1250 are allowed to be in the closed configuration, and (ii) A connection configuration that responds to connecting the flow communication unit to the flow guiding device 230, wherein the outlet barrier is permitted in the flow configuration, wherein outlet sealing members 1046, 1146, 1246 are arranged to contact the flow guiding device to provide channel seals 1060, 1160, 1260 downstream of channel outlet 1049, thereby allowing flow communication between channel outlets 1049, 1149, 1249 and the flow guiding device, wherein channel outlets 1049, 1149, 1249 for the first channel are arranged at the outlet surface (242) of the flow communication unit.

[0468] Thus, when the channel inlet is arranged to communicate with the drug delivery flow and the flow communication units 1040, 1140, 1240 are in a connected configuration, a combined flow channel 267 can be provided between the drug delivery device 210, the first channel 247 and the flow guiding device 230, wherein the channel seal is arranged downstream of the channel outlet.

[0469] In this way, the flow communication units 1040, 1140, and 1240 are adapted to enable long-term use of the reusable drug delivery device, and thereby the flow communication units are adapted to inhibit the entry of microorganisms into the reusable drug delivery device during long-term use.

[0470] Refer to the implementation scheme in Figures 10 and 12—locking components In some embodiments, the flow communication units 1040, 1240 according to this disclosure further include outlet barrier locking members 1050.10, 1250.10, which are adapted to be released by the flow guiding device 230 upon connection. The outlet barrier is also adapted to be in (i) a closed configuration, wherein the outlet surface is in an unconnected configuration, wherein the outlet barrier is locked in a distal position by the outlet barrier locking members 1050.10, 1250.10, and (ii) a flow configuration, wherein the outlet surface is in a connected configuration, wherein the outlet barrier is released and allowed to move to a proximal position.

[0471] In some embodiments, the barrier locking members 1050.10, 1250.10 of the flow communication units 1040, 1240 according to the present disclosure are also adapted to be released by the connecting member 230.10 of the flow guiding device 230.

[0472] List of Implementation Plans 1. A flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) for establishing flow communication from a reusable drug delivery device (210) suitable for long-term use to a flow guiding device (230), wherein the drug delivery device (210) includes a reservoir comprising multiple doses of a liquid drug formulation, wherein the reservoir is adapted to pressurize the liquid drug formulation, wherein the flow guiding device (230) is adapted to guide the drug to the subcutaneous tissue of a subject, wherein the flow communication unit comprises: - An inlet surface (241) for interfacing with a drug delivery device (210), - An outlet surface (242) configured to: (i) a connected configuration, wherein the outlet surface allows the flow communication unit and the flow guiding device to be connected, and wherein the outlet surface is adapted to interface with the flow guiding device (230); and (ii) a disconnected configuration, wherein the outlet surface allows the flow communication unit and the flow guiding device to be disconnected, and wherein the outlet surface is adapted to reduce the entry of contaminants into the internal space (245) of the flow communication unit. - Intermediate surfaces (243, 244) extending between the inlet surface and the outlet surface, wherein the outlet surface is in any of the connected and unconnected configurations, the inlet surface, the outlet surface and the intermediate surfaces define an outer surface and limit the internal space (245) of the flow communication unit. - Outlet sealing members (246, 546, 646, 746, 846, 946, 1046, 1146, 1246), with respect to the outlet surface in the connection configuration, the outlet sealing member provides a portion of the outlet surface (242), wherein the outlet sealing member (246, 546, 646, 746, 846, 946, 1046, 1146, 1246) is adapted to contact the flow guiding device to establish a tight fluid passage seal (260, 560, 660, 760, 860, 960, 1060, 1160, 1260), wherein the outlet sealing member is adapted to provide tight fluid contact with the flow guiding device, wherein the function of the second valve member is maintained or improved upon contact with the flow guiding device. - A first flow channel (247), comprising: a channel inlet (248, 348, 448, 548, 648, 748, 948, 1048, 1148, 1248), the channel inlet being adapted to provide flow communication with the drug delivery device; and a channel outlet (249, 549, 649, 749, 849, 949, 1049, 1149, 1249), the channel outlet being adapted to provide flow communication with the flow guiding device. - First outlet valve components (554, 654, 754, 854, 954, 1054, 1154, 1254). - An outlet barrier (250, 550, 650, 750, 850, 950, 1050, 1150, 1250), the outlet barrier including a second outlet valve member (555, 655, 755, 855, 955, 1055, 1155, 1255), the second outlet valve member being adapted to cooperate with a first outlet valve member (554, 654, 754, 854, 954, 1054, 1154, 1254), wherein the outlet barrier (250, 550, 650, 750, 850, 950, 1050, 1150, 1250) provides a portion of the outlet surface (242), and wherein the outlet barrier is configured to be in: (i) a closed configuration, wherein the outlet surface is in an unconnected configuration, wherein the second outlet valve member (555, 655, 755, 855, 955, 1055, 1155, 1255) is adapted to cooperate with the first outlet valve member (554, 654, 754, 854, 954, 1054, 1154, 1254) to provide an outlet barrier seal (253, 553, 653, 753, 853, 953, 1053, 1153, 1253), and wherein the outlet barrier seal is adapted to reduce contaminants entering the first flow channel through the channel outlet, and (ii) A flow configuration wherein the outlet surface is in the connection configuration, wherein the second outlet valve member (555, 655, 755, 855, 955, 1055, 1155, 1255) is adapted to cooperate with the first outlet valve member (554, 654, 754, 854, 954, 1054, 1154, 1254) to allow a drug contained in the first flow channel (247) to flow downstream from the channel inlet and out from the channel outlet (249, 549, 749, 849, 949, 1049, 1149, 1249) in response to a pressure in the first flow channel (247) exceeding a first threshold. The flow communication unit is further adapted to be in: (i) an unconnected configuration that responds to disconnecting the flow communication unit from the flow guiding device, wherein the outlet surface is in the unconnected configuration and wherein the outlet barrier is in the closed configuration, and (ii) A connection configuration responsive to connecting the flow communication unit to the flow guiding device (230), wherein the outlet surface is in the connection configuration, wherein the outlet barrier is in the flow configuration, wherein the outlet sealing members (246, 546, 646, 746, 946, 1046, 1146, 1246) are arranged to contact the flow guiding device to provide downstream of the channel outlet (249, 549, 649, 749, 849, 949, 1049, 1149) of the first flow channel. The channel seals (260, 560, 660, 760, 860, 960, 1060, 1160, 1260) are adapted to allow flow communication between the channel outlets (249, 549, 649, 749, 849, 949, 1049, 1149, 1249) and the flow guiding device, wherein the channel outlets (249, 549, 649, 749, 849, 949, 1049, 1149, 1249) are arranged at the outlet surface (242) of the flow communication unit; and In response to the channel inlet being arranged in flow communication with the drug delivery device and the flow communication units (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) being connected to the flow guiding device, a combined flow channel (267) can be provided between the drug delivery device (210), the first flow channel (247) and the flow guiding device (230), wherein the channel seal is arranged downstream of the channel outlet; Thus, the flow communication units (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) are adapted to enable long-term use of the reusable drug delivery device, and thus, the flow communication units are adapted to inhibit the entry of microorganisms into the reusable drug delivery device during the long-term use.

[0473] Channel Exit 2. The flow communication unit according to embodiment 1, wherein the exit barriers (550, 650, 750, 850, 950) provide the channel exits (549, 649, 749, 849, 949).

[0474] one-way valve 3. The flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) according to any one of embodiments 1, wherein the flow communication unit further comprises a one-way valve (270) arranged along the first flow channel (247) and adapted to guide downstream flow and inhibit upstream flow toward the drug delivery device.

[0475] Proximal puncture needle 4. The flow communication unit (1140, 1240) according to any one of embodiments 1 and 3, wherein the flow communication unit further includes a proximal puncture needle (391, 491, 1191, 1291) extending from the inlet surface in an extension configuration, wherein the proximal needle includes a proximal opening end providing the channel inlet (249).

[0476] 5. The flow communication unit according to embodiment 4, wherein the flow communication unit further includes a proximal puncture needle actuator (492) adapted to change the proximal puncture needle from the retracted configuration to the extended configuration in response to connecting the flow communication unit to the flow guiding device.

[0477] Implementation plan: Figures 5, 6, 7, 8, and 9 6. The flow communication unit according to any one of embodiments 1 and 3, wherein the flow communication unit further comprises a proximal valve member (598, 698, 798, 898, 998) adapted to allow flow from the inlet toward the outlet and to prevent backflow.

[0478] 7. The flow communication unit according to embodiment 6, wherein the proximal valve member (598, 698, 798, 898, 998) provides a portion of the inlet surface (241) for interfacing with the drug delivery device (210).

[0479] 8. The flow communication unit according to any one of embodiments 6 to 7, wherein the proximal valve member (598, 698, 798, 898, 998) is provided as a portion of the intermediate surface (243, 244) extending between the inlet surface (241) and the outlet surface (242).

[0480] 9. The flow communication unit according to any one of embodiments 6 to 8, wherein the portion of the intermediate surface (243, 244) is flexible and provides a device sealing surface (598.1, 698.1, 798.1, 898.1, 998.1) to seal the drug delivery device (210).

[0481] Implementation plan: Figures 5, 6, 7, and 8 10. The flow communication unit according to any one of embodiments 6 to 9, wherein the proximal valve member provides the channel inlet (548, 648, 748, 848).

[0482] Implementation plan: Figure 5 Proximal support member 11. The flow communication unit according to any one of embodiments 1, 3 and 6 to 10, wherein the flow communication unit further comprises a proximal support member (597, 797), the proximal support member comprising a proximal end (597.9, 797.9) and a proximal portion (597.10, 797.10), the proximal portion being adapted to support the proximal valve member (598, 798).

[0483] 12. The flow communication unit according to embodiment 11, wherein the proximal support member (597) is rigid, and wherein the proximal portion of the proximal support member (597) includes a surface portion defining a proximal valve seat (597.1) adapted to provide a proximal seat sealing surface (597.2), wherein the proximal valve member (598) includes a surface portion adapted to provide a proximal valve sealing surface (598.2), and wherein a proximal fluid tight seal (597.3) is capable of being provided between the proximal valve sealing surface (598.2) and the proximal valve seat sealing surface (597.2).

[0484] 13. The flow communication unit according to any one of embodiments 11 to 12, wherein the proximal support member (597) is rigid and provides a proximal portion of the first flow channel (247).

[0485] 14. The flow communication unit according to embodiment 13, wherein the proximal portion of the first flow channel (247) provided by the proximal support member (597) extends from the proximal end (597.9) of the proximal support member (597).

[0486] 15. The flow communication unit according to any one of embodiments 13 to 14, wherein the proximal valve member (598) includes a surface portion providing a portion of the inlet surface (241) to interface with the drug delivery device (210), and wherein the proximal valve member (598) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface (241).

[0487] 16. The flow communication unit according to embodiment 15, wherein the flow communication unit (540) includes a normally closed configuration, wherein the proximal valve member is in the normal configuration, thereby providing a tight seal (597.3) for the proximal fluid.

[0488] 17. The flow communication unit according to embodiment 16, wherein the proximal support member (597) includes an enlarged channel portion (597.4) adapted to receive a receiving portion (598.3) of the proximal valve member, wherein the receiving portion of the proximal valve member includes the proximal valve sealing surface (598.2), wherein the flow communication unit (540) includes an open configuration, wherein the enlarged channel portion (597.4) receives the receiving portion of the proximal valve member in the forced configuration, and wherein the proximal fluid tight seal (597.3) is not provided.

[0489] 18. The flow communication unit according to any one of embodiments 11 to 17, wherein the proximal support member (597, 697) further includes a support portion (597.5, 697.5) adapted to be supported by the drug delivery device (210) to provide the flow communication unit with support relative to the drug delivery device (210).

[0490] Intermediate valve components 19. The flow communication unit according to any one of embodiments 1, 6 to 18, includes an intermediate valve component (594).

[0491] 20. The flow communication unit according to embodiment 19, wherein the proximal support member (597) includes a distal end (597.11) and a distal portion (597.12), the distal portion being adapted to support the intermediate valve member (594).

[0492] 21. The flow communication unit according to embodiment 20, wherein the proximal support member (597) is rigid, and wherein the distal portion (597.12) of the proximal support member (597) includes a surface portion defining an intermediate valve seat (597.6) adapted to provide an intermediate seat sealing surface (597.7), wherein the intermediate valve member (594) includes a surface portion adapted to provide an intermediate valve sealing surface (594.1), and wherein an intermediate fluid tight seal (597.8) is capable of being provided between the intermediate valve sealing surface (594.1) and the intermediate seat sealing surface (597.7).

[0493] 22. The flow communication unit according to any one of embodiments 20 to 21, wherein the proximal portion of the first flow channel (247) provided by the proximal support member (597) extends from the proximal end (597.9) to the distal end (597.11).

[0494] 23. The flow communication unit according to any one of embodiments 19 to 22, wherein the intermediate valve member (594) includes a proximal surface portion for interfacing with the proximal support member (597), and wherein the intermediate valve member (594) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0495] 24. The flow communication unit according to embodiment 23, wherein the normally closed configuration of the flow communication unit (540) further includes the intermediate valve member being in the normal configuration and providing a tight seal (597.8) for the intermediate fluid.

[0496] Distal support member 25. The flow communication unit according to any one of embodiments 1, 6 to 24, includes a distal support member (593).

[0497] 26. The flow communication unit according to embodiment 25, wherein the distal support member (593) is rigid and provides the distal portion of the first flow channel (247).

[0498] 27. The flow communication unit according to embodiment 26, wherein the distal support member (593) includes an enlarged channel portion (593.1) adapted to receive a portion of a flexible portion (594.2) of the intermediate valve member (594), wherein the flexible portion (594.2) of the intermediate valve member (594) includes the intermediate valve sealing surface (594.1), wherein the opening configuration of the flow communication unit (540) further includes the enlarged channel portion (593.1) receiving a portion of the flexible portion of the intermediate valve member in the forced configuration, wherein the intermediate fluid tight seal (597.3) is not provided.

[0499] 28. The flow communication unit according to any one of embodiments 25 to 27, wherein the distal support member (593) further includes a support portion adapted to be supported by the proximal support member and thereby providing stability to the flow communication unit.

[0500] 29. The flow communication unit according to any one of embodiments 25 to 28, wherein the distal support member (593) and the proximal support member (597) are adapted to clamp a portion of the intermediate valve member (594), and the clamped portion is thus fixed, while the unclamped portion is adapted to move between the normal configuration and the forced configuration.

[0501] 30. The flow communication unit according to any one of embodiments 25 to 29, wherein the distal support member (593) further includes a support portion adapted to be supported by the drug delivery device (210) to provide support for the flow communication unit relative to the drug delivery device (210).

[0502] Export barriers 31. The flow communication unit according to any one of embodiments 1, 25 to 30, wherein the distal support member (593) includes a distal end and a distal portion, the distal portion being adapted to support the outlet barrier (550).

[0503] 32. The flow communication unit according to embodiment 31, wherein the distal support member (593) is rigid, and wherein the distal portion of the distal support member (593) includes a surface portion defining a first outlet valve member (554) adapted to provide a seat sealing surface, wherein the outlet barrier (550) includes a surface portion defining a second outlet valve member (555) adapted to provide a valve sealing surface, and wherein the outlet barrier seal (553) is capable of being provided between the valve sealing surface and the valve seat sealing surface.

[0504] 33. The flow communication unit according to any one of embodiments 31 to 32, wherein the outlet barrier (550) includes a proximal surface portion for interfacing with the distal support member (593), and wherein the outlet barrier (550) is flexible and capable of changing from a normal configuration to a forced configuration in response to pressure in the first flow channel (247) and on the proximal surface portion exceeding the first threshold.

[0505] 34. The flow communication unit according to embodiment 33, wherein the normally closed configuration of the flow communication unit (540) further includes the outlet barrier in the normal configuration and providing the outlet barrier seal (553).

[0506] 35. The flow communication unit according to embodiment 34, wherein the flow guiding device (230) includes an enlarged channel inlet (238) adapted to receive a portion of a flexible portion (550.1) of the outlet barrier (550), wherein the flexible portion (550.1) of the outlet barrier (550) includes the valve sealing surface, wherein the opening configuration of the flow communication unit further includes the enlarged channel inlet (238) receiving a portion of the flexible portion (550.1) of the outlet barrier in the forced configuration, wherein the outlet barrier seal (553) is not provided.

[0507] 36. The flow communication unit according to any one of the foregoing embodiments, wherein the outlet barrier (550) provides the outlet sealing member (546).

[0508] Implementation plan: Figure 6 37. The flow communication unit according to any one of embodiments 1, 3 and 6 to 10, wherein the flow communication unit further includes a support member (697) comprising a proximal end (697.9) and a proximal portion (697.10), the proximal portion being adapted to support the proximal valve member (698).

[0509] 38. The flow communication unit according to embodiment 37, wherein the support member (697) is rigid, wherein the proximal valve member (698) is a self-sufficient valve (698), the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal (698.2) is capable of being provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0510] 39. The flow communication unit according to any one of embodiments 37 to 38, wherein the support member (697) is rigid, and wherein the proximal portion of the support member (697) includes a proximal valve housing (697.1) adapted to receive a receiving portion (698.3) of the self-propelled valve (698).

[0511] 40. The flow communication unit according to any one of embodiments 37 to 39, wherein the support member (697) provides a portion of the first flow channel (247).

[0512] 41. The flow communication unit according to embodiment 40, wherein a portion of the first flow channel (247) extends from the proximal end (697.9) of the support member (697).

[0513] 42. The flow communication unit according to any one of embodiments 38 to 41, wherein the self-sufficient valve (698) includes a surface portion that provides a portion of the inlet surface (241) for interfacing with the drug delivery device (210), and wherein the self-sufficient valve (698) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface (241).

[0514] 43. The flow communication unit according to embodiment 42, wherein the flow communication unit (640) includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing the proximal fluid tight seal (698.2).

[0515] 44. The flow communication unit according to embodiment 43, wherein the flow communication unit (540) includes an open configuration, wherein the self-sufficient valve is in the forced configuration, and wherein the proximal fluid tight seal (698.2) is not provided.

[0516] 45. The flow communication unit according to embodiment 44, wherein the proximal valve housing (697.1) includes an enlarged channel portion adapted to receive the receiving portion (698.3), wherein the receiving portion of the self-sustaining valve includes a first proximal valve sealing surface and a second proximal valve sealing surface, wherein the receiving portion expands radially as the self-sustaining valve changes from the normal configuration to the forced configuration, and wherein the proximal valve housing is adapted to provide a stop for the radial expansion, thereby limiting the maximum expansion.

[0517] 46. ​​The flow communication unit according to any one of embodiments 37 to 45, wherein the support member (697) further includes a support portion (697.5) adapted to be supported by the drug delivery device (210) to provide support for the flow communication unit relative to the drug delivery device (210).

[0518] Export barriers 47. The flow communication unit according to any one of embodiments 37 to 46, wherein the support member (697) includes a distal end (697.11) and a distal portion (697.12), the distal portion being adapted to support the outlet barrier (650).

[0519] 48. The flow communication unit according to embodiment 47, wherein the distal portion (697.12) includes a surface portion defining a first outlet valve member (654) adapted to provide a seat sealing surface, wherein the outlet barrier (650) includes a surface portion defining a second outlet valve member (655) adapted to provide a valve sealing surface, and wherein the outlet barrier seal (653) is capable of being provided between the valve sealing surface and the seat sealing surface.

[0520] 49. The flow communication unit according to any one of embodiments 47 to 48, wherein the outlet barrier (650) includes a proximal surface portion for interfacing with the distal portion (697.12), and wherein the outlet barrier (650) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0521] 50. The flow communication unit according to embodiment 49, wherein the normally closed configuration of the flow communication unit (640) further includes the outlet barrier in the normal configuration and providing the outlet barrier seal (653).

[0522] 51. The flow communication unit according to embodiment 50, wherein the flow guiding device (230) includes an enlarged channel inlet (238) adapted to receive a portion of a flexible portion (650.1) of the outlet barrier (650), wherein the flexible portion (650.1) of the outlet barrier (650) includes the valve sealing surface, wherein the opening configuration of the flow communication unit further includes the enlarged channel inlet (238) receiving a portion of the flexible portion (650.1) of the outlet barrier in the forced configuration, wherein the outlet barrier seal (653) is not provided.

[0523] Implementation plan: Figure 7 Proximal support member 52. The flow communication unit according to any one of embodiments 1, 3 and 6 to 10, wherein the flow communication unit further comprises a proximal support member (797), the proximal support member comprising a proximal end (797.9) and a proximal portion (797.10), the proximal portion being adapted to support the proximal valve member (798).

[0524] 53. The flow communication unit according to embodiment 52, wherein the proximal support member (797) is rigid, wherein the proximal valve member (798) is a self-sufficient valve (798), the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal (798.2) is capable of being provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0525] 54. The flow communication unit according to any one of embodiments 52 to 53, wherein the proximal support member (797) is rigid, and wherein the proximal valve member includes a skirt adapted to surround and securely engage the proximal portion (797.1) of the proximal support member (797).

[0526] 55. The flow communication unit according to any one of embodiments 53 to 54, wherein the self-sufficient valve (798) includes a surface portion that provides a portion of the inlet surface (241) for interfacing with the drug delivery device (210), and wherein the self-sufficient valve (798) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface (241).

[0527] 56. The flow communication unit according to embodiment 55, wherein the flow communication unit (740) includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing the proximal fluid tight seal (798.2).

[0528] 57. The flow communication unit according to embodiment 56, wherein the flow communication unit (740) includes an open configuration, wherein the self-sufficient valve is in the forced configuration, and wherein the proximal fluid tight seal (798.2) is not provided.

[0529] 58. The flow communication unit according to embodiment 57, wherein the proximal portion (797.1) of the proximal support member (797) includes an enlarged channel portion adapted to receive a portion of a flexible portion (798.3) of the self-sustaining valve (798), wherein the flexible portion includes a portion of a first proximal valve sealing surface and a portion of a second proximal valve sealing surface, wherein the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from the normal configuration to the forced configuration, and wherein the proximal portion (797.1) is adapted to provide a stop for the axial deflection, thereby limiting a maximum deflection.

[0530] 59. The flow communication unit according to any one of embodiments 52 to 58, wherein the proximal support member (797) further includes a support portion (797.5) adapted to be supported by the drug delivery device (210) and thereby providing support for the flow communication unit relative to the drug delivery device (210).

[0531] Proximal support member – distal section / exit barrier 60. The flow communication unit according to any one of embodiments 52 to 59, wherein the proximal support member (797) includes a distal end (797.11) and a distal portion (797.12), the distal portion being adapted to support the outlet barrier (750).

[0532] 61. The flow communication unit according to embodiment 60, wherein the proximal support member (797) is rigid, and wherein the distal portion (797.12) of the proximal support member (797) includes a surface portion defining a first outlet valve member (754) adapted to provide a seat sealing surface, wherein the outlet barrier (750) includes a surface portion defining a second outlet valve member (755) adapted to provide a valve sealing surface, and wherein the outlet barrier seal (753) is capable of being provided between the valve sealing surface and the seat sealing surface.

[0533] 62. The flow communication unit according to any one of embodiments 60 to 61, wherein the outlet barrier (750) includes an inner surface portion for interface with the distal portion (797.12) of the proximal support member (797), and wherein the outlet barrier (750) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0534] 63. The flow communication unit according to embodiment 62, wherein the normally closed configuration of the flow communication unit (740) further includes the outlet barrier in the normal configuration and providing the outlet barrier seal (753).

[0535] 64. The flow communication unit according to any one of embodiments 52 to 63, wherein the proximal support member (797) provides a proximal portion of the first flow channel (247).

[0536] 65. The flow communication unit according to embodiment 64, wherein the proximal portion of the first flow channel (247) extends from the proximal end (797.9) to the intermediate position (797.13).

[0537] 66. The flow communication unit according to embodiment 65, wherein a distal portion of the first flow channel (247) is disposed between the distal portion (797.12) and the outlet barrier (750), and wherein the distal portion of the first flow channel extends from the intermediate position (797.13) to the outlet (749).

[0538] Intermediate valve components 67. The flow communication unit according to any one of embodiments 1, 6 to 10, 52 to 66, wherein the outlet barrier (750) provides an intermediate valve component (750.2).

[0539] 68. The flow communication unit according to embodiment 67, wherein the distal portion (797.12) of the proximal support member (797) is adapted to support the intermediate valve member (750.2).

[0540] 69. The flow communication unit according to embodiment 68, wherein the distal portion (797.12) of the proximal support member (797) includes a surface portion defining an intermediate valve seat (750.3) adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member (750.2) includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal is capable of being provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0541] 70. The flow communication unit according to any one of embodiments 67 to 69, wherein the intermediate valve member (750.2) includes an inner surface portion for interfacing with the proximal support member (797), and wherein the intermediate valve member (750.2) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0542] 71. The flow communication unit according to embodiment 70, wherein the normally closed configuration of the flow communication unit (740) further includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid.

[0543] 72. The flow communication unit according to any one of embodiments 67 to 71, wherein the intermediate valve member is located in the distal portion of the first flow channel (247).

[0544] Distal support member 73. The flow communication unit according to any one of embodiments 1, 6 to 10, 52 to 72, includes a distal support member (793).

[0545] 74. The flow communication unit according to embodiment 73, wherein the distal support member (793) includes a tubular portion (793.1) adapted to receive a receiving portion of the outlet barrier (750), wherein the receiving portion expands radially as the outlet barrier (750) changes from the normal configuration to the forced configuration, and wherein the tubular portion (793.1) is adapted to provide a stop for the radial expansion, thereby limiting the maximum expansion.

[0546] 75. The flow communication unit according to embodiment 74, wherein the receiving portion of the outlet barrier (750) includes the second outlet valve member (755), wherein the opening configuration of the flow communication unit (740) further includes the outlet barrier in the forced configuration, and wherein the outlet barrier seal (753) is not provided.

[0547] 76. The flow communication unit according to embodiment 74, wherein the receiving portion of the outlet barrier (750) includes the intermediate valve member (750.2), wherein the opening configuration of the flow communication unit (740) further includes the outlet barrier in the forced configuration, and wherein the intermediate fluid tight seal is not provided.

[0548] 77. The flow communication unit according to any one of embodiments 73 to 76, wherein the distal support member (793) further includes a support portion adapted to be supported by the proximal support member, thereby providing stability to the flow communication unit.

[0549] Distal sealing member 78. A flow communication unit according to any one of embodiments 1, 6 to 10, 52 to 77, including a distal sealing member (794) that provides the outlet sealing member (746).

[0550] 79. The flow communication unit according to embodiment 78, wherein the distal support member (793) is adapted to support the distal sealing member (794).

[0551] Implementation plan: Figure 8 Proximal valve components 80. The flow communication unit according to any one of embodiments 1, 3 and 6 to 10, wherein the proximal valve member further includes a support portion adapted to be supported by the drug delivery device (210), thereby providing support for the flow communication unit relative to the drug delivery device (210).

[0552] 81. A flow communication unit according to any one of embodiments 6 to 10, 80, wherein the proximal valve member is adapted to be fitted into an adapter top (290) having a retaining member on an inner surface, wherein the proximal valve member includes a flat distal surface and a recess adapted to receive the retaining member when the proximal valve member is inserted into the adapter top (290), and thereby the distal surface remains flat to allow close contact with another flat surface.

[0553] Proximal support member 82. The flow communication unit according to any one of embodiments 1 and 6 to 10, 80 to 81, wherein the flow communication unit further comprises a proximal support member (897), the proximal support member comprising a proximal end (897.9) and a proximal portion (897.10), the proximal portion being adapted to support the proximal valve member (898).

[0554] 83. The flow communication unit according to embodiment 82, wherein the proximal support member (897) is rigid, wherein the proximal valve member (898) is a self-sufficient valve (898), the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal (898.2) is capable of being provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0555] 84. The flow communication unit according to any one of embodiments 82 to 83, wherein the proximal support member (897) is rigid and has a flat proximal surface, and wherein the self-sustaining valve includes a substantially flat distal surface, and wherein the proximal support member is adapted to transmit compressive force to the self-sustaining valve (898), and wherein the self-sustaining valve is adapted to transmit compressive force to the drug delivery device.

[0556] 85. The flow communication unit according to any one of embodiments 82 to 84, wherein the proximal support member (897) is rigid, and wherein the proximal support member is adapted to be fitted into an adapter top (290) having a retaining member on an inner surface, and wherein the proximal support member includes a flat proximal surface adapted to be supported by the retaining member, and thereby the proximal surface can be held in close contact with the flat distal surface of the self-sustaining valve (898) when the proximal support member (897) and the self-sustaining valve (898) are inserted into the adapter top (290).

[0557] 86. The flow communication unit according to any one of embodiments 80 to 85, wherein the proximal support member (897) is rigid and provides a proximal portion of the first flow channel (247).

[0558] 87. The flow communication unit according to embodiment 86, wherein the proximal portion of the first flow channel (247) provided by the proximal support member extends from the proximal end (897.9) of the proximal support member (897).

[0559] 88. A flow communication unit according to any one of embodiments 82 to 87, wherein the self-sufficient valve (898) includes a surface portion that provides a portion of the inlet surface (241) for interfacing with the drug delivery device (210), and wherein the self-sufficient valve (898) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface (241).

[0560] 89. The flow communication unit according to embodiment 88, wherein the flow communication unit (840) includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing a tight seal (898.2) for the proximal fluid.

[0561] 90. The flow communication unit according to embodiment 89, wherein the flow communication unit (840) includes an open configuration, wherein the self-sufficient valve is in the forced configuration, and wherein the proximal fluid tight seal (898.2) is not provided.

[0562] 91. The flow communication unit according to embodiment 90, wherein the proximal portion (897.1) of the proximal support member (897) includes an enlarged channel portion adapted to receive a portion of a flexible portion (898.3) of the self-sustaining valve (898), wherein the flexible portion includes a portion of a first proximal valve sealing surface and a portion of a second proximal valve sealing surface, wherein a portion of the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from the normal configuration to the forced configuration, and wherein the proximal portion (897.1) is adapted to provide a stop for the axial deflection, thereby limiting a maximum deflection.

[0563] Intermediate valve components 92. A flow communication unit according to any one of implementation schemes 1, 6 to 10, 80 to 91, including an intermediate valve component (894).

[0564] 93. The flow communication unit according to embodiment 92, wherein the proximal support member (897) includes a distal end (897.11) and a distal portion (897.12), the distal portion being adapted to support the intermediate valve member (894).

[0565] 94. The flow communication unit according to embodiment 93, wherein the proximal support member (897) is rigid, and wherein the distal portion (897.12) of the proximal support member (897) includes a surface portion defining an intermediate valve seat (897.6) adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member (894) includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal (897.8) is capable of being provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0566] 95. The flow communication unit according to any one of embodiments 86 to 94, wherein the proximal portion of the first flow channel (247) extends from the proximal end (897.9) to the distal end (897.11).

[0567] 96. The flow communication unit according to any one of embodiments 92 to 95, wherein the intermediate valve member (894) includes a proximal surface portion for interfacing with the distal portion of the proximal support member (897), and wherein the intermediate valve member (894) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the proximal surface.

[0568] 97. The flow communication unit according to embodiment 96, wherein the normally closed configuration of the flow communication unit (840) further includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid (897.8).

[0569] Distal support member 98. The flow communication unit according to any one of embodiments 1, 6 to 10, 80 to 97, includes a distal support member (893).

[0570] 99. The flow communication unit according to embodiment 98, wherein the distal support member (893) is rigid and provides the distal portion of the first flow channel (247).

[0571] 100. The flow communication unit according to embodiment 99, wherein the distal support member (893) includes an enlarged channel portion (893.1) adapted to receive a portion of a flexible portion (894.2) of the intermediate valve member (894), wherein the flexible portion (894.2) of the intermediate valve member (894) includes the intermediate valve sealing surface (894.1), wherein the opening configuration of the flow communication unit (840) further includes the enlarged channel portion (893.1) receiving a portion of the flexible portion of the intermediate valve member in the forced configuration, wherein the intermediate fluid tight seal (897.3) is not provided.

[0572] 101. A flow communication unit according to any one of embodiments 98 to 100, wherein the proximal support member (897), the intermediate valve member (894), and the distal support member (893) are provided by a unit, wherein a portion of the intermediate valve member is clamped between the support members, and wherein the support members are ultrasonically welded together.

[0573] 102. The flow communication unit according to embodiment 101, wherein the clamped portion is fixed, and the unclamped portion is flexible and adapted to move between the normal configuration and the forced configuration.

[0574] Export barriers 103. The flow communication unit according to any one of embodiments 1, 6 to 10, 80 to 102, wherein the distal support member (893) includes a distal end and a distal portion, the distal portion being adapted to support the outlet barrier (850).

[0575] 104. The flow communication unit according to embodiment 103, wherein the distal support member (893) is rigid, and wherein the outlet barrier (850) is a self-sufficient valve (850), the self-sufficient valve comprising: a first valve member (854) including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member (855) including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal (853) is provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0576] 105. A flow communication unit according to any one of embodiments 103 to 104, wherein the self-sustaining valve (850) includes a proximal surface portion for covering the first flow channel (247), and wherein the self-sustaining valve (850) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure in the first flow channel and thus in response to fluid pressure on the proximal surface portion of the self-sustaining valve.

[0577] 106. The flow communication unit according to embodiment 105, wherein the normally closed configuration of the flow communication unit (840) includes the self-sufficient valve in the normal configuration, thereby providing the proximal fluid tight seal (853).

[0578] 107. The flow communication unit according to embodiment 106, wherein the opening configuration of the flow communication unit (840) includes the self-sufficient valve in the forced configuration, and wherein the proximal fluid tight seal (853) is not provided.

[0579] 108. The flow communication unit according to embodiment 107, wherein the proximal portion (897.1) of the proximal support member (897) includes an enlarged channel portion adapted to receive a portion of a flexible portion (898.3) of the self-sustaining valve (898), wherein the flexible portion includes a portion of a first proximal valve sealing surface and a portion of a second proximal valve sealing surface, wherein a portion of the flexible portion axially deflects into the enlarged channel portion in response to the self-sustaining valve changing from the normal configuration to the forced configuration, and wherein the proximal portion (897.1) is adapted to provide a stop for the axial deflection, thereby limiting a maximum deflection.

[0580] 109. The flow communication unit according to any one of embodiments 103 to 108, wherein the distal support member (893) is rigid and has a flat distal surface, and wherein the self-sufficient valve includes a substantially flat proximal surface, and wherein the distal support member is adapted to transmit compressive force to the outlet barrier (850), and wherein the outlet barrier is adapted to transmit compressive force to the top of the adapter (290).

[0581] 110. The flow communication unit according to any one of embodiments 103 to 109, wherein the proximal support member (897) is rigid, and wherein the proximal support member, the intermediate valve member, the distal support member and the outlet barrier are adapted to be fitted into an adapter top (290) having a retaining member on an inner surface, and wherein the proximal support member includes a flat proximal surface adapted to be supported by the retaining member, and thereby the proximal surface is able to maintain close contact with the flat distal plane of the proximal valve member (898) when all members are inserted into the adapter top (290).

[0582] 111. A flow communication unit according to any one of embodiments 103 to 110, wherein the proximal support member (897), the intermediate valve member (894) and the distal support member (893) provide a unit, wherein a portion of the intermediate valve member is clamped between the support members, and wherein the unit is adapted to be fitted into an adapter top (290) having a unit holding member adapted to hold the unit in a compressed state.

[0583] 112. The flow communication unit according to embodiment 111, wherein the outlet barrier and the unit are adapted to be held in the top of the adapter in a compressed state, wherein the holding member is capable of transmitting the compressive force to the unit, and the unit is capable of transmitting the compressive force to the holding surface of the top (290) of the adapter.

[0584] 113. The flow communication unit according to embodiment 111, wherein the outlet barrier and the unit are adapted to be held in the top of the adapter in a compressed state, wherein the proximal valve member is adapted to be fitted into the top of the adapter in a compressed state, and wherein the top of the adapter includes a device retaining member on its inner surface, wherein the device retaining member is adapted to connect the top of the adapter to the drug retaining device, wherein the proximal valve member is supported by the drug delivery device in a compressed state.

[0585] 114. A flow communication unit according to any one of embodiments 103 to 113, wherein the flow guiding device (230) includes an enlarged channel inlet (238) adapted to receive a portion of a flexible portion (850.1) of the self-sustaining valve (850), wherein the flexible portion (850.1) of the self-sustaining valve (850) includes a portion of the outlet barrier seal (853), wherein the opening configuration of the flow communication unit further includes the enlarged channel inlet (238) receiving a portion of the flexible portion (850.1) of the outlet barrier in the forced configuration, wherein the outlet barrier seal (853) is not provided.

[0586] 115. The flow communication unit according to any one of the foregoing embodiments 104 to 113, wherein the outlet barrier (850) provides the outlet sealing member (846).

[0587] Implementation plan: Figure 9 Proximal valve components 116. The flow communication unit according to any one of embodiments 1, 3 and 6 to 9, wherein the proximal valve member provides the channel inlet (948) in normal configuration, wherein the valve is closed.

[0588] 117. The flow communication unit according to any one of embodiments 6 to 9, 116, wherein the proximal valve member provides a passageway under a forced configuration, wherein the valve is open.

[0589] 118. The flow communication unit according to any one of embodiments 6 to 9, 116 to 117, wherein the proximal valve member includes a distal surface portion for interfacing with a movable channel member, and wherein the proximal valve member (998) is flexible and capable of changing from a normal configuration to a forced configuration in response to pressure from the movable channel member on the distal surface portion.

[0590] Proximal support member 119. A flow communication unit according to any one of embodiments 1, 6 to 9 and 116 to 118, wherein the flow communication unit further comprises a proximal support member (997), the proximal support member comprising a proximal end (997.9) and a proximal portion (997.10), the proximal portion being adapted to support the proximal valve member (998).

[0591] 120. The flow communication unit according to embodiment 119, wherein the proximal support member (997) is rigid, wherein the proximal valve member (998) is a self-sufficient valve (998), the self-sufficient valve comprising: a first valve member including a surface portion adapted to provide a first proximal valve sealing surface; and a second valve member including a surface portion adapted to provide a second proximal valve sealing surface, wherein a proximal fluid tight seal (998.2) is capable of being provided between the first proximal valve sealing surface and the second proximal valve sealing surface.

[0592] 121. The flow communication unit according to any one of embodiments 119 to 120, wherein the proximal support member (997) is rigid, and wherein the self-sustaining valve (998) includes a skirt adapted to surround the proximal portion (997.1) of the proximal support member (997) and / or be surrounded by the proximal portion of the proximal support member, thereby fixing the self-sustaining valve and the proximal support member to each other.

[0593] 122. A flow communication unit according to any one of embodiments 119 to 121, wherein the self-sustaining valve (998) comprises: a proximal surface portion providing a portion of the inlet surface (241) for interfacing with the drug delivery device (210); and a distal surface portion for interfacing with a movable channel member, wherein the self-sustaining valve (998) is flexible, and (i) wherein the self-sustaining valve is capable of changing from a normal configuration to a forced configuration in response to pressure from the movable channel member on the distal surface portion, and (ii) wherein the movable channel member supports the self-sustaining valve (998) in the normal configuration in response to fluid pressure on the inlet surface (241), thereby maintaining a tight fluid seal (998.2).

[0594] 123. A flow communication unit according to any one of embodiments 119 to 122, wherein the flow communication unit (940) includes a normally closed configuration, wherein the self-sufficient valve is in the normal configuration, thereby providing a tight seal (998.2) for the proximal fluid.

[0595] 124. A flow communication unit according to any one of embodiments 119 to 123, wherein the flow communication unit (940) includes an open configuration, wherein the self-sustaining valve is in the forced configuration, and the channel inlet (948) is provided by the movable channel member, and wherein the proximal fluid tight seal (998.2) is not provided.

[0596] 125. A flow communication unit according to any one of embodiments 119 to 124, wherein the proximal portion (997.1) of the proximal support member (997) is adapted to receive a portion of a defined channel seat portion of the self-sustaining valve (998), wherein the channel seat portion is adapted to provide a seat for the proximal portion of the movable channel member in a distal position, and wherein the self-sustaining valve is in the forced configuration.

[0597] 126. A flow communication unit according to any one of embodiments 119 to 125, wherein the proximal portion (997.1) of the proximal support member (997) is adapted to receive a portion of a defined channel seat portion of the self-sustaining valve (998), wherein the channel seat portion is adapted to provide a seat for a distal portion of the movable channel member in a proximal position, wherein the movable channel member extends across the self-sustaining valve (998), wherein the self-sustaining valve (998) provides a seal around the movable channel member, and wherein the self-sustaining valve is in the forced configuration.

[0598] 127. The flow communication unit according to any one of embodiments 119 to 126, wherein the proximal support member (997) further includes a support portion (997.5) adapted to be supported by the drug delivery device (210) to provide support for the flow communication unit relative to the drug delivery device (210).

[0599] Proximal support member - distal part 128. The flow communication unit according to any one of embodiments 119 to 127, wherein the proximal support member (997) includes a distal end (997.11) and a distal portion (997.12), the distal portion being adapted to support the outlet barrier (750).

[0600] Distal support member 129. The flow communication unit according to any one of embodiments 1, 6 to 9, 116 to 128 further includes a distal support member (993).

[0601] 130. The flow communication unit according to embodiment 129, wherein the proximal support member (997) includes a tubular portion adapted to receive the distal support member (993), wherein the distal support member (993) is movably disposed within the tubular portion, and wherein the distal support member is adapted to move between a distal position and a proximal position.

[0602] 131. The flow communication unit according to any one of embodiments 129 to 130, wherein the distal support member (993) includes a proximal end (993.9) and a proximal portion (993.10), the proximal portion including a movable channel member.

[0603] 132. The flow communication unit according to any one of embodiments 129 to 131, wherein the distal support member (993) includes a distal end (993.11) and a distal portion (993.12), the distal portion being adapted to support the outlet barrier (950).

[0604] 133. The flow communication unit according to embodiment 129, wherein the distal support member (993) is rigid, and wherein the distal portion (993.12) of the distal support member (993) includes a surface portion defining a first outlet valve member (954) adapted to provide a seat sealing surface, wherein the outlet barrier (950) includes a surface portion defining a second outlet valve member (955) adapted to provide a valve sealing surface, and wherein the outlet barrier seal (953) is capable of being provided between the valve sealing surface and the seat sealing surface.

[0605] 134. The flow communication unit according to any one of embodiments 129 to 133, wherein the outlet barrier (950) includes an inner surface portion for interface with the distal portion (993.12) of the distal support member (993), and wherein the outlet barrier (950) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0606] 135. The flow communication unit according to embodiment 134, wherein the normally closed configuration of the flow communication unit (940) further includes the outlet barrier in the normal configuration and providing the outlet barrier seal (953).

[0607] 136. The flow communication unit according to any one of embodiments 131 to 135, wherein the proximal portion (993.10) of the distal support member (993) provides the proximal portion of the first flow channel (247).

[0608] 137. The flow communication unit according to embodiment 136, wherein the proximal portion of the first flow channel (247) extends from the proximal end (993.9) to the intermediate position (993.13).

[0609] 138. The flow communication unit according to embodiment 137, wherein a distal portion of the first flow channel (247) is disposed between the distal portion (993.12) and the outlet barrier (950), and wherein the distal portion of the first flow channel extends from the intermediate position (997.13) to the outlet (949).

[0610] 139. The flow communication unit according to any one of embodiments 129 to 138 further includes a biasing member (994) adapted to bias the distal support member (993) toward the distal position.

[0611] 140. The flow communication unit according to embodiment 139, wherein the biasing member (994) is located between the distal surface of the proximal support member (998) and the proximal surface of the distal support member (993).

[0612] 141. The flow communication unit according to embodiment 140, wherein the biasing member (994) is a compression spring.

[0613] Intermediate valve components 142. The flow communication unit according to any one of embodiments 1, 6 to 9, 116 to 141, wherein the outlet barrier (950) provides an intermediate valve member (950.2).

[0614] 143. The flow communication unit according to embodiment 142, wherein the distal portion (993.12) of the distal support member (993) is adapted to support the intermediate valve member (950.2).

[0615] 144. The flow communication unit according to embodiment 143, wherein the distal portion (993.12) of the distal support member (993) includes a surface portion defining an intermediate valve seat (993.14) adapted to provide an intermediate seat sealing surface, wherein the intermediate valve member (950.2) includes a surface portion adapted to provide an intermediate valve sealing surface, and wherein an intermediate fluid tight seal is capable of being provided between the intermediate valve sealing surface and the intermediate seat sealing surface.

[0616] 145. The flow communication unit according to any one of embodiments 142 to 144, wherein the intermediate valve member (950.2) includes an inner surface portion for interfacing with the distal support member (993), and wherein the intermediate valve member (950.2) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inner surface portion.

[0617] 146. The flow communication unit according to embodiment 145, wherein the normally closed configuration of the flow communication unit (940) further includes the intermediate valve member being in the normal configuration and providing a tight seal for the intermediate fluid.

[0618] 147. The flow communication unit according to any one of embodiments 142 to 146, wherein the intermediate valve member is located in the distal portion of the first flow channel (247) and provides additional security.

[0619] Export barriers 148. The flow communication unit according to any one of embodiments 1, 6 to 9, 116 to 147, wherein the outlet sealing member (946) is provided by the outlet barrier (950).

[0620] Implementation plan: Figure 10 149. The flow communication unit (1040, 1140, 1240) according to any one of embodiments 1, 3 and 4, wherein the flow communication unit further comprises: A central portion (1198, 1298) extending from the inlet surface (241) to the outlet surface (242), wherein the central portion provides a portion of the inlet surface and the outlet surface, and wherein the central portion includes the first flow channel (247), the central portion also including a side surface extending in one direction between the inlet surface and the outlet surface (242), wherein the channel outlet (1049, 1149) and the first outlet valve member (1054, 1154, 1254) are disposed in the side surface, and wherein the first outlet valve member surrounds the channel outlet (1049, 1149, 1249). The outlet barriers (1050, 1150, 1250) surround the central portion and provide the second outlet valve component (1055, 1155, 1255), wherein the outlet barriers (1050, 1150, 1250) are movably arranged and capable of moving between a distal position and a proximal position. When the outlet barriers (1050, 1150, 12050) are located in the proximal position, the outlet surface (242) can be arranged in the connection configuration. When the outlet barriers (1050, 1150, 1250) are located at the distal position, the outlet surface (242) can be arranged in the unconnected configuration. The circumferential portions (1197, 1297) connected to the central portion provide the intermediate surfaces (243, 244), which extend between the inlet surface and the outlet surface, wherein the circumferential portions include a portion of the inlet surface and the outlet surface. Wherein, for the outlet surface (242) in either the connected configuration or the unconnected configuration, the inlet surface, the outlet surface, and the intermediate surface define the outer surface and limit the internal space (245) of the flow communication unit, wherein the outlet barrier is located on the proximal or distal side. The outlet sealing members (1046, 1146, 1246) are disposed on the side surface of the central portion, and the outlet sealing members surround the channel outlet (1049, 1149, 1249), thereby providing a portion of the outlet surface (242) of the connection configuration. The outlet barriers (1050, 1150, 1250) provide a portion of the outlet surface (242). When the outlet surface is in the unconnected configuration, the outlet surface provided by the outlet barrier is flush with the outlet portion provided by the central portion and the circumferential portion, thereby making it easier to keep the outlet surface clean. Furthermore, when the outlet surface is in the connection configuration, the outlet surface provided by the outlet barrier is partially recessed relative to the outlet surface provided by the central portion and the circumferential portion. The second outlet valve component (1055, 1155, 1255) is adapted to cooperate with the first outlet valve component (1054, 1154) to provide an outlet barrier seal (1053, 1153, 1253), wherein the outlet barrier is adapted to be in the following position: (i) A closed configuration, wherein the outlet surface is in the unconnected configuration, whereby the outlet barrier is in the distal position, and whereby the outlet barrier seal is adapted to reduce the entry of contaminants, and (ii) A flow configuration wherein the outlet surface is located in the connection configuration, thereby the outlet barrier is located in the proximal position, thereby the outlet barrier (1050, 1150, 1250) is adapted to allow a drug contained in the first flow channel (247) to flow downstream from the channel inlet and out from the channel outlet (1049, 1149, 1249) in response to a pressure in the first flow channel (247) exceeding the first threshold. The flow communication unit is further adapted to be in: (i) the unconnected configuration, which responds to disconnecting the flow communication unit from the flow guiding device—and wherein the outlet barriers (1050, 1150, 1250) are allowed in the closed configuration, and (ii) The connection configuration, in response to connecting the flow communication unit to the flow guiding device (230), wherein the outlet barrier is permitted to be in the flow state, wherein the outlet sealing members (1046, 1146, 1246) are arranged to contact the flow guiding device to provide the channel seal (1060, 1160, 1260) downstream of the channel outlet (1049), thereby allowing flow communication between the channel outlet (1049, 1149, 1249) and the flow guiding device, wherein the channel outlet (1049, 1149, 1249) for the first flow channel is arranged at the outlet surface (242) of the flow communication unit; and When the channel inlet is arranged to be in flow communication with the drug delivery device and the flow communication units (1040, 1140, 1240) are in the connection configuration, a combined flow channel (267) can be provided between the drug delivery device (210), the first flow channel (247) and the flow guiding device (230), wherein the channel seal is arranged downstream of the channel outlet; Therefore, the flow communication units (1040, 1140, 1240) are adapted to enable long-term use of the reusable drug delivery device, and thus, the flow communication units are adapted to inhibit the entry of microorganisms into the reusable drug delivery device during long-term use.

[0621] 150. The flow communication unit (1040, 1240) according to embodiment 149 further includes an outlet barrier locking member (1050.10, 1250.10), the outlet barrier locking member being adapted to be released by the flow guiding device (230) upon connection, wherein the outlet barrier is further adapted to be in the following position: (i) the closed configuration, wherein the outlet surface is in the unconnected configuration, wherein the outlet barrier is locked in the distal position by the outlet barrier locking members (1050.10, 1250.10), and (ii) A flow configuration in which the outlet surface is in the connection configuration, wherein the outlet barrier is released and allowed to move to the proximal position.

[0622] 151. The flow communication unit (1040, 1240) according to embodiment 150, wherein the barrier locking member (1050.10, 1250.10) is further adapted to be released by the connecting member (230.10) of the flow guiding device (230).

Claims

1. A flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) for establishing flow communication from a reusable drug delivery device (210) suitable for long-term use to a flow guiding device (230), wherein the drug delivery device (210) includes a reservoir containing multiple doses of a liquid drug formulation, wherein the reservoir is adapted to pressurize the liquid drug formulation, wherein the flow guiding device (230) is adapted to guide the liquid drug formulation to the subcutaneous tissue of a subject, wherein the flow communication unit comprises: - An inlet surface (241) for interfacing with a drug delivery device (210), - An outlet surface (242) configured to: (i) a connected configuration, wherein the outlet surface allows the flow communication unit and the flow guiding device (230) to be connected, and wherein the outlet surface is adapted to interface with the flow guiding device (230); and (ii) a disconnected configuration, wherein the outlet surface allows the flow communication unit and the flow guiding device to be disconnected, and wherein the outlet surface is adapted to reduce the entry of contaminants into the internal space (245) of the flow communication unit. - Intermediate surfaces (243, 244) extending between the inlet surface and the outlet surface, wherein the outlet surface is in any of the connected and unconnected configurations, the inlet surface, the outlet surface and the intermediate surfaces define an outer surface and limit the internal space (245) of the flow communication unit. - Outlet sealing members (246, 546, 646, 746, 846, 946, 1046, 1146, 1246), with respect to the outlet surface in the connection configuration, the outlet sealing members provide a portion of the outlet surface (242), wherein the outlet sealing members (246, 546, 646, 746, 846, 946, 1046, 1146, 1246) are adapted to contact the flow guiding device to establish a tight fluid channel seal (260, 560, 660, 760, 860, 960, 1060, 1160, 1260). - A first flow channel (247), comprising: a channel inlet (248, 348, 448, 548, 648, 748, 948, 1048, 1148, 1248), the channel inlet being adapted to provide flow communication with the drug delivery device; and a channel outlet (249, 549, 649, 749, 849, 949, 1049, 1149, 1249), the channel outlet being adapted to provide flow communication with the flow guiding device. - First outlet valve components (554, 654, 754, 854, 954, 1054, 1154, 1254). - An outlet barrier (250, 550, 650, 750, 850, 950, 1050, 1150, 1250), the outlet barrier including a second outlet valve member (555, 655, 755, 855, 955, 1055, 1155, 1255), the second outlet valve member being adapted to cooperate with a first outlet valve member (554, 654, 754, 854, 954, 1054, 1154, 1254), wherein the outlet barrier (250, 550, 650, 750, 850, 950, 1050, 1150, 1250) provides a portion of the outlet surface (242), and wherein the outlet barrier is configured to be in: (i) a closed configuration, wherein the outlet surface is in an unconnected configuration, wherein the second outlet valve member (555, 655, 755, 855, 955, 1055, 1155, 1255) is adapted to cooperate with the first outlet valve member (554, 654, 754, 854, 954, 1054, 1154, 1254) to provide an outlet barrier seal (253, 553, 653, 753, 853, 953, 1053, 1153, 1253), and wherein the outlet barrier seal is adapted to reduce contaminants entering the first flow channel through the channel outlet, and (ii) A flow configuration wherein the outlet surface is in the connection configuration, wherein the second outlet valve member (555, 655, 755, 855, 955, 1055, 1155, 1255) is adapted to cooperate with the first outlet valve member (554, 654, 754, 854, 954, 1054, 1154, 1254) to allow a liquid pharmaceutical preparation contained in the first flow channel (247) to flow downstream from the channel inlet and out from the channel outlet (249, 549, 749, 849, 949, 1049, 1149, 1249) in response to a pressure in the first flow channel (247) exceeding a first threshold. The flow communication unit is also adapted to be in the following position: (i) an unconnected configuration that responds to disconnecting the flow communication unit from the flow guiding device, wherein the outlet surface is in the unconnected configuration and wherein the outlet barrier is in the closed configuration, and (ii) A connection configuration responsive to connecting the flow communication unit to the flow guiding device (230), wherein the outlet surface is in the connection configuration, wherein the outlet barrier is in the flow configuration, wherein the outlet sealing members (246, 546, 646, 746, 946, 1046, 1146, 1246) are arranged to contact the flow guiding device to provide downstream of the channel outlet (249, 549, 649, 749, 849, 949, 1049, 1149) of the first flow channel. The channel seals (260, 560, 660, 760, 860, 960, 1060, 1160, 1260) are adapted to allow flow communication between the channel outlets (249, 549, 649, 749, 849, 949, 1049, 1149, 1249) and the flow guiding device, wherein the channel outlets (249, 549, 649, 749, 849, 949, 1049, 1149, 1249) are arranged at the outlet surface (242) of the flow communication unit; and In response to the channel inlet being arranged in flow communication with the drug delivery device and the flow communication units (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) being connected to the flow guiding device, a combined flow channel (267) can be provided between the drug delivery device (210), the first flow channel (247) and the flow guiding device (230), wherein the channel seal is arranged downstream of the channel outlet; Thus, the flow communication units (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) are adapted to enable long-term use of the reusable drug delivery device, and thus, the flow communication units are adapted to inhibit the entry of microorganisms into the reusable drug delivery device during the long-term use.

2. The flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) according to claim 1, wherein the flow communication unit further comprises a one-way valve (270) arranged along the first flow channel (247) and adapted to guide downstream flow and inhibit upstream flow toward the drug delivery device.

3. The flow communication unit (240, 540, 640, 740, 840, 940) according to claim 1 or 2, wherein the outlet barrier (550, 650, 750, 850, 950) provides the channel outlet (549, 649, 749, 849, 949).

4. The flow communication unit (240, 540, 640, 740, 840, 940) according to claim 1 or 2, wherein the flow communication unit further comprises a proximal valve member (598, 698, 798, 898, 998) adapted to allow flow from the channel inlet toward the channel outlet and to prevent backflow.

5. The flow communication unit according to claim 4, wherein the proximal valve member (598, 698, 798, 898, 998) provides a portion of the inlet surface (241) for interfacing with the drug delivery device (210).

6. The flow communication unit according to claim 4, wherein the proximal valve member (598, 698, 798, 898, 998) is provided as a portion of the intermediate surface (243, 244) extending between the inlet surface (241) and the outlet surface (242).

7. The flow communication unit according to claim 6, wherein the portion of the intermediate surface (243, 244) is flexible and provides device sealing surfaces (598.1, 698.1, 798.1, 898.1, 998.1) to seal the drug delivery device (210).

8. The flow communication unit (240, 540, 640, 740, 840) according to claim 4, wherein the proximal valve member provides the channel inlet (548, 648, 748, 848).

9. The flow communication unit (540, 840) according to claim 1 or 2, wherein the flow communication unit further comprises a distal support member (593, 893), the distal support member comprising a distal end and a distal portion, the distal portion being adapted to support the outlet barrier (550, 850), and wherein - The distal support member further includes barrier operating members (593.2, 893.2), which are adapted to cooperate with the outlet barrier to adjust the tightness of the outlet barrier seal (553, 853). - The outlet barrier (550, 850) includes an actuator portion (550.2, 850.2) that provides the outlet sealing member (546, 846) and is movably disposed between a first position and a second position relative to the barrier operating member (593.2), and is adapted to be configured to be in: (i) An unconnected configuration, wherein the outlet barrier is in the closed configuration, wherein the closed configuration of the outlet barrier further includes the actuator portion (550.2) in the first position relative to the barrier operating member (593.2, 893.2), whereby the second outlet valve member (555, 855) is adapted to cooperate with the first outlet valve member (554, 854) to provide the outlet barrier seal (553, 853), the outlet barrier seal being adapted to allow liquid pharmaceutical preparations contained in the first flow channel to flow downstream from the channel inlet and out from the channel outlet (549, 849) in response to a pressure in the first flow channel (247) exceeding a second threshold, wherein the second threshold defines the tightness of the outlet barrier seal (553, 853) in the unconnected configuration and is greater than the first threshold. (ii) A connection configuration wherein the outlet barrier is located in the flow configuration, wherein the flow configuration of the outlet barrier further includes the actuator portion (550.2) in a second position relative to the barrier operating member (593.2, 893.2), whereby the second outlet valve member (555, 855) is adapted to cooperate with the first outlet valve member (554, 854) to provide the outlet barrier seal (553, 853), the outlet barrier seal being adapted to allow a liquid pharmaceutical preparation contained in the first flow channel to flow downstream from the channel inlet and out from the channel outlet (549, 849) in response to a pressure in the first flow channel (247) exceeding a first threshold, wherein the first threshold defines the tightness of the outlet barrier seal in the connection configuration.

10. The flow communication unit of claim 9, wherein the actuator portion is adapted to be manipulated from the first position to the second position by the flow guiding device during connection.

11. The flow communication unit according to claim 4, wherein the flow communication unit further comprises a proximal support member (597, 797), the proximal support member comprising a proximal end (597.9, 797.9) and a proximal portion (597.10, 797.10), the proximal portion being adapted to support the proximal valve member (598, 798).

12. The flow communication unit of claim 11, wherein the proximal support member (597) is rigid, and wherein the proximal portion of the proximal support member (597) includes a surface portion defining a proximal valve seat (597.1) adapted to provide a proximal seat sealing surface (597.2), wherein the proximal valve member (598) includes a surface portion adapted to provide a proximal valve sealing surface (598.2), and wherein a proximal fluid tight seal (597.3) is capable of being provided between the proximal valve sealing surface (598.2) and the proximal seat sealing surface (597.2).

13. The flow communication unit according to claim 11, wherein the proximal support member (597) is rigid and provides a proximal portion of the first flow channel (247).

14. The flow communication unit according to claim 13, wherein the proximal portion of the first flow channel (247) provided by the proximal support member (597) extends from the proximal end (597.9) of the proximal support member (597).

15. The flow communication unit according to claim 13 or 14, wherein the proximal valve member (598) includes a surface portion that provides a portion of the inlet surface (241) for interfacing with the drug delivery device (210), and wherein the proximal valve member (598) is flexible and capable of changing from a normal configuration to a forced configuration in response to fluid pressure on the inlet surface (241).

Images