Container adapters in fluid transfer systems

Abstract

A container adapter connectable to a first container of a fluid transfer system for transferring fluid between a first container and a second container of a fluid transfer system. The container adapter includes a fluid channel configured to facilitate the transfer of fluid between the first container and the second container. The container adapter includes a first barrier at least partially located within the fluid channel, a second barrier at least partially located within the fluid channel, and an isolation volume at least partially defined between the first barrier and at least a portion of the second barrier, configured to communicate with the second container and at least partially isolated from the first container during fluid transfer.

Description

Technical Field

[0001] The subject matter of the present disclosure relates to the field of fluid transfer devices, and more particularly, to an adapter for connecting to a container of a fluid transfer system and facilitating fluid transfer.

Background Art

[0002] An adapter is generally connected to a container to facilitate the transfer of fluid between a first container and a second container. For example, in a fluid transfer system such as a pharmaceutical preparation system, the first container contains a large amount of fluid received from the second container, and the adapter is connected to the first container to facilitate fluid transfer. Preventive measures need to be taken to reduce or completely avoid the occurrence of cross-contamination and microbial invasion caused by solids, liquids, droplets or gas residues from substances contained in the first container and accumulating in a part of the second container.

[0003] For example, during dilution of a solid or liquid substance in a vial, a syringe needle is inserted into the vial to discharge a diluent into the vial. Exposure of the needle to the vial contents can cause accumulation of substance residues at its tip. Careful measures are taken to prevent cross-contamination and microbial invasion caused by introducing the residues accumulated at the tip into subsequent vials. Such measures can include discarding the syringe after one use and providing a new syringe for diluting subsequent vials.

Summary of the Invention

[0004] In a pharmaceutical preparation system, when transferring fluid between a second container and a plurality of first containers, a device, system, and method are provided for transferring fluid between the first container and the second container while facilitating repeated use of the second container.

[0005] More specifically, in the field of drug transport, drugs and / or diluents are contained in vials and / or IV bags and need to be transported to different containers for mixing with other drugs in liquid or solid form, and for delivery to the patient, for example, by syringes and / or other IV bags. Generally, in some cases, for example, in environments handling hazardous drugs or non-hazardous drugs, it is practiced to connect syringes and / or IV bags to vials and / or other IV bags via adapters.

[0006] In some embodiments, the fluid transfer system comprises a robotic system configured to handle and manipulate containers in order to carry out the transfer of fluid. For example, the robotic system is described as having a manipulator configured to manipulate containers. Also, while in all embodiments described herein the manipulator is described as a robotic arm, it will be understood that the manipulator may be a platform, robotic station, etc., having a holding section for holding components of the fluid transfer device and moving them relative to one another to facilitate the performance of fluid transfer.

[0007] The following terms and their derivatives used throughout this application may be better understood in consideration of the following explanations.

[0008] A pharmaceutical preparation system may include one or more dilution stations, i.e., reconstitution stations, to which any type of diluent is added to a drug in solid and / or liquid form. A pharmaceutical preparation system may include one or more filling stations, i.e., compounding stations to which a drug that is at least partially or completely prepared is transferred into a container by aspiration of the drug from a first container and injected into a further container.

[0009] The terms "pharmaceuticals" and "drugs" are used interchangeably.

[0010] The fluid transfer conduit may comprise any means for transferring fluid, or, for example, a needle or tube. The needle may comprise a cannula or any other device configured to penetrate a container and transfer fluid through it. The needle may include a slope at its distal tip, or an opening on its side, or any other configuration.

[0011] A partition can generally refer to a membrane configured to block access to a part of the device to which it belongs. Generally, a partition on a container or container connector can seal the container. A partition on a container can prevent or resist access to a fluid transfer conduit. Typically, partitions are made from an elastic, perforated material. Such a material may be a polymer with elastic properties such as rubber or any other suitable material.

[0012] A robotic system may include an automated or partially automated system comprising a manipulator that is at least partially controlled by a controller unit (also referred to as a controller or control unit).

[0013] The manipulator may include a robotic arm, platform, robotic station, or a combination thereof configured to operate a container and / or fluid transfer assembly.

[0014] A controller or controller unit may comprise a computer controller configured to perform operations according to a set of instructions stored in memory readable by the controller, which may be executed by a central processing unit (CPU) and / or separate processing units, one or more processors, processor units, microprocessors, etc. In another embodiment, the controller or controller unit comprises one or more control circuits. In some embodiments, the control unit may include one or more mechanical controllers. The controller unit may comprise any means for controlling elements in a robotic pharmaceutical preparation system and may comprise at least one of a controller, a synchronization unit, and a processor.

[0015] A robotic pharmaceutical preparation system comprises a robotic system capable of performing any activity related to the preparation of a drug designated for administration to a patient. It should be noted that the term “robotic system” as used herein may include a robotic pharmaceutical preparation system.

[0016] The terms proximal and distal should be understood herein in relation to the user. In the embodiments described herein, the first container is positioned more distal to the user than the second container, but the order is interchangeable.

[0017] The longitudinal axis L1 extends centrally along the length of the container adapter.

[0018] The lateral axis L2 is perpendicular to the longitudinal axis L1 and extends toward its side, corresponding to the width of the container adapter.

[0019] The central plane P includes the transverse axis L2 and traverses the longitudinal axis L1.

[0020] The lateral orientation within the main body (for example, the first barrier body 142 in Figure 3) refers to the orientation that extends outward from the center of the main body to the side of the main body.

[0021] Inward orientation within the main body refers to the orientation that extends from the side of the main body toward its center.

[0022] The container adapter may be configured to be deployed for the preparation of any type of drug, including hazardous and non-hazardous drugs, prepared within a closed system. Additionally, the drug preparation system may be deployed for the preparation of any type of drug, including hazardous and non-hazardous drugs, prepared within a closed system.

[0023] Accordingly, according to one embodiment of the present application, a container adapter is provided that can be connected to a first container of a fluid transfer system for transferring fluid between a first container and a second container of the fluid transfer system.

[0024] The first and second containers described herein may include any containers that are components of a fluid transfer device, with or without adapters or connectors for establishing fluid communication between the first and second containers. It should be understood that the first and second containers may include any containers configured to receive a fluid (gas or liquid or a combination thereof) therein. For example, the first or second container may include intravenous bags (IV bags), fluid transfer pipes, conduits, etc., although the first or second container is described herein with reference to vials and / or syringes. Furthermore, the first or second container may include a fluid transfer assembly such as a syringe, or a syringe assembly including a syringe and a syringe connector. In some embodiments, the fluid transfer assembly may include a pump mechanism and a fluid transfer pipe configured to connect to the first or second container for drug transfer. In some embodiments, the fluid transfer assembly may include a fluid transfer connector (or adapter) for establishing fluid communication between the fluid transfer unit (fluid transfer pipe, conduit, pump, syringe, etc.) and the first or second container.

[0025] Furthermore, in the embodiments described herein, fluid transfer is carried out by a fluid transfer conduit. The fluid transfer conduit may include a needle that penetrates the container slab while entering the first or second container. In some embodiments, it is understood herein that fluid transfer can be carried out without the needle penetrating the container slab, or optionally without penetrating the slab of a fluid transfer connector (associated with a fluid transfer assembly). In some embodiments, fluid transfer can be carried out via a fluid transfer conduit by controlling the fluid pressure, even without a needle.

[0026] The container adapter includes a fluid flow path configured to facilitate the transfer of fluid between a first container and a second container. The container adapter includes a first barrier at least partially positioned within the fluid flow path, a second barrier at least partially positioned within the fluid flow path, and an isolation volume at least partially defined between at least a portion of the first barrier and the second barrier, the isolation volume being configured to be in fluid communication with the second container and at least partially isolated from the first container during fluid transfer.

[0027] The first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an open state operable to permit fluid flow therethrough in at least a direction extending from the second container to the first container.

[0028] The isolation volume fluidically isolates its volume portion and is configured to prevent fluid exchange through the first barrier during the closed state, such as when the container adapter is connected to the first or second container.

[0029] The isolation volume can be sized to any size. For example, the isolation volume can comprise a portion of the interior portion 140 of the container adapter 120 as shown in FIGS. 5A and 6, or can be defined within a partition wall 152 as shown in FIGS. 7 and 9. In some embodiments, the isolation volume can be defined by a relatively small volume, such as a volume containing fluid discharged by a fluid transfer conduit.

[0030] The first barrier can be configured to separate between the isolation volume and an exposed volume fluidically exposed to the fluid contained within the first or second container.

[0031] In some embodiments, the isolation volume can be sized to any suitable size for receiving fluid therein.

[0032] Accordingly, according to one embodiment of the present application, a container adapter is provided which can be connected to a first container of a fluid transfer system for the transfer of fluid between a first container and a second container of a fluid transfer system, the adapter comprising a fluid channel configured to facilitate the transfer of fluid between the first container and the second container; a first barrier at least partially located within the fluid channel; a second barrier at least partially located within the fluid channel; and an isolation volume at least partially defined between the first barrier and at least a portion of the second barrier, configured to communicate with the second container and isolated from the first container during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state which can be operated to prevent the flow of fluid through it and an open state which can be operated to allow the flow of fluid through it at least in a direction extending from the second container to the first container during the transfer of fluid.

[0033] In some embodiments, the container adapter includes a proximal end portion, a distal end portion that extends distally from the proximal end portion toward a first container toward a first container when connected to the container adapter, at least partially along the longitudinal axis of the adapter, and an internal portion that extends between the proximal end portion and the distal end portion, wherein the fluid flow path extends at least partially within the internal portion, at least partially along the longitudinal axis.

[0034] In some embodiments, the first barrier comprises a first barrier body, the first barrier body comprising a surface facing the first container (first container-facing surface) configured to face at least partially toward the first container when connected to a container adapter, a second container-facing surface configured to face at least partially opposite to the first container-facing surface, and a first barrier peripheral wall extending from the first container-facing surface to the surface facing the second container (second container-facing surface).

[0035] In some embodiments, the first barrier is located in the fluid channel intermediate between the proximal and distal ends. In some embodiments, the first barrier is located in the fluid channel closer to the proximal end than to the distal end.

[0036] In some embodiments, the first barrier is positioned in the fluid flow path closer to the distal end than to the proximal end. In some embodiments, the first barrier comprises a first barrier mounting element that can be mounted on a corresponding adapter mounting element of the internal portion. In some embodiments, the first barrier mounting element includes a flange that can be mounted on the corresponding adapter mounting element, and the adapter mounting element is formed with a recess configured to receive the flange. In some embodiments, the peripheral wall of the first barrier is configured to be mountable on a corresponding adapter wall of the container adapter. In some embodiments, the corresponding adapter wall of the container adapter constitutes the wall of the internal portion.

[0037] In some embodiments, the second barrier constitutes at least a portion of the partition wall, the partition wall having a partition wall body, the partition wall body comprising a proximal partition wall surface, a distal partition wall surface extending distally from the proximal partition wall surface along the longitudinal axis of the adapter, and a peripheral partition wall extending between the proximal and distal partition wall surfaces.

[0038] In some embodiments, the partition wall is at least partially located within the proximal end portion. In some embodiments, the first barrier is located distally along the longitudinal axis from the proximal surface of the partition wall. In some embodiments, the distal surface of the partition wall at least partially constitutes the second barrier. In some embodiments, the proximal surface of the partition wall at least partially constitutes the second barrier. In some embodiments, the distal surface of the partition wall at least partially constitutes the first barrier, and the isolation volume extends at least partially between the proximal and distal surfaces of the partition wall. In some embodiments, the first barrier is at least partially located within the partition wall body.

[0039] In some embodiments, the partition wall is configured to be at least partially permeable by a fluid transfer conduit associated with the second vessel. In some embodiments, the partition wall is configured to be repeatedly permeable by the fluid transfer conduit, at least when inserting the fluid transfer conduit into and removing it from the second barrier.

[0040] In some embodiments, the isolation volume is configured to receive at least a portion of a fluid transfer conduit associated with the second container. In some embodiments, the isolation volume is configured to receive fluid discharged by the fluid transfer conduit associated with the second container and to retain the fluid therein while the first barrier is closed. In some embodiments, the first barrier is configured to allow needleless fluid inflow into the first container through it while the first barrier is open. In some embodiments, the first barrier includes a permeable material to allow the fluid transfer conduit associated with the second container to permeate the first barrier at least partially to facilitate the suction of fluid from the first container to the second container.

[0041] In some embodiments, the first barrier is configured to divide the fluid flow path into an isolated volume section and an exposed volume section, the exposed volume section extending distally from the first barrier and being exposed to the first container and in fluid communication with the first container when the first container is connected to the container adapter.

[0042] In some embodiments, at least a portion of the exposed volume extends distally from the first barrier within the container adapter. In some embodiments, in the open state, the first barrier allows fluid to flow at least from the isolated volume to the exposed volume. In some embodiments, in the closed state, the first barrier prevents fluid flow between the isolated volume and the exposed volume. In some embodiments, the first barrier is configured to displace from a closed state to an open state in response to a pressure difference applied across the first barrier.

[0043] In some embodiments, a pressure difference is applied in the direction of the fluid flow, across the first barrier during its transfer. In some embodiments, the first barrier is configured to displace from a closed state to an open state when the pressure in the isolation volume increases above a predetermined open pressure threshold. In some embodiments, the first barrier is configured to displace from an open state to a closed state when the pressure in the isolation volume decreases to below a predetermined closed threshold. In some embodiments, the predetermined open threshold and the predetermined closed threshold are the same. In some embodiments, the predetermined open threshold and the predetermined closed threshold are different. In some embodiments, the predetermined open threshold is greater than the predetermined closed threshold. In some embodiments, the open threshold and the closed threshold correspond to the pressure in the isolation volume acting on the first barrier. In some embodiments, the predetermined open threshold and the closed threshold correspond to the pressure in the isolation volume acting on the second container-facing surface of the first barrier.

[0044] In some embodiments, a predetermined open threshold is determined based on the degree of openness of at least the first barrier. Additionally or alternatively, a predetermined closed threshold is determined based on the degree of the tendency of at least the first barrier to close.

[0045] Additionally, or alternatively, a predetermined opening threshold is determined based on one or more of the dimensions and / or shape of the isolation volume, the properties of the first barrier body including at least one of the toughness of the body material, the distribution of the body material along at least the surface located on a plane transverse to an axis parallel to the direction of fluid flow, and the orientation of the body with respect to the direction of fluid flow, and the contact area formed between the peripheral wall of the first barrier and the corresponding wall of the adapter.

[0046] Additionally, or alternatively, a predetermined closure threshold is determined based on at least one of the dimensions and / or shape of the isolation volume, the properties of the first barrier body including at least one of the body material elasticity, the distribution of the body material along at least one of the surfaces located on a plane transverse to an axis parallel to the direction of fluid flow, and the orientation of the body with respect to the direction of fluid flow, and the contact area formed between the peripheral wall of the first barrier and the corresponding wall of the adapter.

[0047] In some embodiments, the contact formed in the contact area is at least partially sealed. In some embodiments, the first barrier includes an opening configured to open during the displacement from a closed state to an open state and to reclose during the transition from a closed state to an open state. In some embodiments, the opening is formed at least partially along the central portion of the first barrier body.

[0048] In some embodiments, the first barrier body is positioned such that its dimensions increase along an axis parallel to the direction of fluid flow, resulting in an increase in material that begins at the opening and gradually increases laterally toward the surrounding wall.

[0049] In some embodiments, the first barrier includes a valve comprising a chamber that at least partially defines the isolation volume and an opening. In some embodiments, the valve includes one of a duckbill-shaped valve, a dome-shaped valve, and a disc-shaped valve. In some embodiments, the valve is formed with at least one projection extending laterally from the peripheral wall toward the corresponding adapter wall. In some embodiments, the chamber extends from the second vessel-facing surface and terminates at or near the second barrier. In some embodiments, the chamber extends from the second vessel-facing surface and terminates at or near the distal surface of the partition. Additionally or alternatively, the chamber extends from the second vessel-facing surface and terminates at or near the proximal surface of the partition.

[0050] In some embodiments, a partition wall at least partially constitutes a first barrier, and the isolated volume is at least partially defined within a slit formed within the partition wall at least at the distal surface of the partition wall. In some embodiments, the slit terminates within the partition wall body between the proximal and distal surfaces of the partition wall, and the partition wall body is formed of a penetrable material configured to receive a portion of the second container. In some embodiments, the slit extends from the distal surface of the partition wall to the proximal surface of the partition wall. Additionally or alternatively, the first barrier includes a bidirectional valve that is selectively displaceable between a closed state and an open state, which is operable to allow fluid flow through it in that direction and in the opposite direction, extending from the first container to the second container.

[0051] In some embodiments, the second container-facing surface and the first container-facing surface are parallel to each other and further parallel to a plane that intersects an axis parallel to the direction of fluid flow.

[0052] In some embodiments, the distance along the parallel axis between the second container-facing surface and the first container-facing surface recedes near the opening. In some embodiments, at least a portion of the isolation volume is predefined within the container adapter before at least the second container engages with the container adapter. In some embodiments, the container adapter is a vial adapter configured to connect to a vial.

[0053] Accordingly, according to one embodiment of the present application, a method is provided for transferring fluid between a first container and a second container associated with a fluid transfer conduit formed with a fluid port, the method comprising providing a container adapter connectable to the first container, the container adapter comprising: a fluid passage configured to facilitate the transfer of fluid between the first container and the second container; a first barrier at least partially located within the fluid passage; and an isolation volume extending from the first barrier toward the second container and configured to communicate fluidly with the second container, and at least partially isolated from the first container during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent the flow of fluid through it and an open state operable to allow the flow of fluid through it at least in a direction extending from the second container toward the first container, the method comprising providing, positioning a fluid port within the isolation volume, and discharging fluid from the fluid port into the isolation volume, thereby displacing the first barrier toward its open state.

[0054] In some embodiments, the container adapter comprises configuring a first container adapter connectable to a first container, removing the fluid port from the isolated volume section of the first container adapter, positioning the fluid port within the isolated volume section of a subsequent container adapter connectable to a subsequent first container, and discharging fluid from the fluid port into the subsequent isolated volume section.

[0055] In some embodiments, the method further includes maintaining the fluid port entirely within the isolated volume during fluid discharge from the fluid port to the isolated volume. In some embodiments, the method further includes drawing fluid from the first vessel to the second vessel through the first barrier. In some embodiments, the drawing includes passing the fluid transfer conduit through at least the first barrier. In some embodiments, the method is carried out using a vessel adapter described in any one of the embodiments described herein.

[0056] Accordingly, according to one embodiment of the present application, a robotic system is provided that can operate to transfer fluid between a first container and a second container having a fluid transfer conduit formed with a fluid port, the first container being connectable to a container adapter comprising: a fluid passage configured to facilitate the transfer of the fluid between the first container and the second container; a first barrier at least partially located within the fluid passage; and an isolation volume extending from the first barrier toward the second container, configured to communicate with the second container and at least partially isolated from the first container during the transfer of the fluid, the first barrier being connected to the fluid passing through it The system is selectively displaceable between a closed state that can be operated to prevent the flow of fluid and an open state that can be operated to allow the flow of fluid through it in a direction extending at least from the second vessel to the first vessel, and the system comprises a controller and a manipulator that is controllable by the controller and configured to operate at least the second vessel, the controller being configured to operate the manipulator to position the fluid port in the isolation volume section at a predetermined distance from at least the first barrier and to maintain the fluid transfer conduit isolated from the first vessel during the transfer of fluid from at least the second vessel to the first vessel.

[0057] In some embodiments, the container adapter comprises a first container adapter connectable to a first container, and further includes a controller configured to operate a manipulator to remove the fluid port from the isolated volume of the first container adapter, position the fluid port within the isolated volume of a subsequent container adapter connectable to a subsequent first container, and discharge the fluid from the fluid port into the subsequent isolated volume.

[0058] In some embodiments, the robotic system further includes a controller configured to operate a manipulator to maintain the fluid port entirely within the isolated volume during fluid discharge from the fluid port into the isolated volume. In some embodiments, the controller is configured to operate a manipulator to cause suction of fluid from the first vessel into the second vessel through the first barrier. In some embodiments, suction includes penetrating the fluid transfer conduit at least through the first barrier.

[0059] [Embodiment] More specific details will be provided in the detailed description, but the following are non-limiting examples of different embodiments of the subject matter of this disclosure. 1. A container adapter connectable to the first container of a fluid transfer system for transferring fluid between the first and second containers of the fluid transfer system, wherein the adapter is A fluid channel configured to facilitate the transfer of the fluid between the first container and the second container, A first barrier positioned at least partially within the fluid channel, A second barrier positioned at least partially within the fluid channel, The invention comprises an isolated volume section at least partially defined between the first barrier and at least a portion of the second barrier, configured to be in fluid communication with the second container, and at least partially isolated from the first container during the transfer of the fluid, A container adapter wherein the first barrier is selectively displaceable between a closed state that is operable to prevent the flow of fluid through it and an open state that is operable to allow the flow of fluid through it at least in a direction extending from the second container to the first container during the transfer of the fluid. 2. The container adapter is, The proximal end portion, When connected to the container adapter, the distal end portion extends distally from the proximal end portion toward the first container, at least partially along the longitudinal axis of the adapter, The container adapter according to Embodiment 1, comprising an internal portion extending between the proximal end portion and the distal end portion, wherein the fluid flow path extends at least partially along the longitudinal axis within the internal portion. 3. The first barrier has a first barrier body, and the first barrier body is A first container-facing surface, configured to face at least partially toward the first container when connected to the container adapter, A second container-facing surface configured to face at least partially opposite to the first container-facing surface, A container adapter according to embodiment 1 or 2, comprising: a first barrier peripheral wall extending from the first container-facing surface to the second container-facing surface. 4. The container adapter according to Embodiment 2 or Embodiment 3, if dependent on Embodiment 2, wherein the first barrier is located in the fluid flow path midway between the proximal end portion and the distal end portion. 5. The container adapter according to Embodiment 4, wherein the first barrier is positioned in the fluid flow path closer to the proximal end portion than to the distal end portion. 6. The container adapter according to Embodiment 4, wherein the first barrier is positioned in the fluid flow path closer to the distal end portion than to the proximal end portion. 7. The container adapter according to Embodiment 2 or any one of Embodiments 3 to 6 dependent on Embodiment 2, wherein the first barrier comprises a first barrier mounting element that can be attached to a corresponding adapter mounting element of the internal portion. 8. The container adapter according to Embodiment 7, wherein the first barrier mounting element comprises a flange that can be mounted on the corresponding adapter mounting element, and the corresponding adapter mounting element is formed with a recess configured to receive the flange. 9. The container adapter according to Embodiment 3 or any one of Embodiments 4 to 8 dependent on Embodiment 3, wherein the first barrier peripheral wall is configured to be attachable to the corresponding adapter wall of the container adapter. 10. The container adapter according to Embodiment 9, which is dependent on Embodiment 2, wherein the corresponding adapter wall of the container adapter constitutes the wall of the internal portion. 11. The second barrier constitutes at least a portion of the partition, the partition having a partition body, the partition body is The proximal surface of the septum, A distal surface of the partition wall extending distally from the proximal surface of the partition wall along the longitudinal axis of the adapter, A container adapter according to any one of embodiments 1 to 10, comprising a peripheral wall of the partition wall extending between the proximal surface of the partition wall and the distal surface of the partition wall. 12. The container adapter according to Embodiment 11, if dependent on Embodiment 2, wherein the partition wall is at least partially located within the proximal end portion. 13. The container adapter according to embodiment 11 or 12, wherein the first barrier is positioned distally along the longitudinal axis from the proximal surface of the partition wall. 14. The container adapter according to any one of embodiments 11 to 13, wherein the distal surface of the partition wall constitutes at least a portion of the second barrier. 15. The container adapter according to any one of embodiments 11 to 13, wherein the proximal surface of the partition wall constitutes at least a portion of the second barrier. 16. The container according to Embodiment 15, wherein the distal surface of the partition wall at least partially constitutes the first barrier, and the isolation volume extends at least partially between the proximal surface of the partition wall and the distal surface of the partition wall. 17. The container adapter according to any one of embodiments 11 to 16, wherein the first barrier is at least partially located within the partition body. 18. The container adapter according to any one of embodiments 11 to 17, wherein the partition wall is configured to be at least partially permeable by a fluid transfer conduit associated with the second container. 19. The container adapter according to Embodiment 18, wherein the partition wall is configured to be repeatedly passable by the fluid transfer conduit, at least when inserting the fluid transfer conduit into and removing it from the second barrier. 20. The container adapter according to any one of embodiments 1 to 19, wherein the isolation volume is configured to receive therein at least a portion of a fluid transfer conduit associated with the second container. 21. The container adapter according to any one of embodiments 1 to 20, wherein the isolation volume is configured to receive fluid discharged by a fluid transfer conduit associated with the second container and to hold the fluid therein while the first barrier is closed. 22. The container adapter according to any one of embodiments 1 to 21, wherein the first barrier is configured to allow needleless inflow of the fluid into the first container through thereto while the first barrier is open. 23. The container adapter according to any one of embodiments 1 to 22, wherein the first barrier includes a penetrable material to allow a fluid transfer conduit associated with the second container to at least partially penetrate the first barrier to facilitate the suction of fluid from the first container to the second container. 24. The container adapter according to any one of embodiments 1 to 23, wherein the first barrier is configured to divide the fluid flow path into an isolated volume section and an exposed volume section, and the exposed volume section extends distally from the first barrier and is exposed to the first container and in fluid communication with the first container when the first container is connected to the container adapter. 25. The container adapter according to Embodiment 24, wherein at least a portion of the exposed volume extends distally from the first barrier within the container adapter. 26. The container adapter according to embodiment 24 or 25, wherein, in the open state, the first barrier allows fluid to flow at least from the isolated volume portion to the exposed volume portion. 27. A container adapter according to any one of embodiments 24 to 26, wherein, in the closed state, the first barrier prevents the flow of fluid between the isolated volume and the exposed volume. 28. The container adapter according to any one of embodiments 1 to 27, wherein the first barrier is configured to displace from the closed state to the open state in response to a pressure difference applied across the first barrier. 29. The container adapter according to Embodiment 28, wherein the pressure difference is applied in the direction of the fluid flow, with the first barrier in between during its transfer. 30. The container adapter according to Embodiment 24 or any one of Embodiments 25 to 29 dependent on Embodiment 24, wherein the first barrier is configured to displace from the closed state to the open state when the differential pressure between the isolated volume portion and the exposed volume portion increases beyond a predetermined open pressure threshold. 31. The container adapter according to Embodiment 24 or any one of Embodiments 25 to 30, wherein the first barrier is configured to displace from the open state to the closed state when the differential pressure between the isolated volume and the exposed volume decreases to a predetermined closing threshold. 32. A container adapter according to Embodiment 31, which is dependent on Embodiment 30, wherein the predetermined opening threshold and the predetermined closing threshold are the same. 33. A container adapter according to Embodiment 31, which is dependent on Embodiment 30, wherein the predetermined opening threshold and the predetermined closing threshold are different. 34. The container adapter according to embodiment 33, wherein the predetermined opening threshold is greater than the predetermined closing threshold. 35. The container adapter according to any one of embodiments 31 to 34, which is dependent on embodiment 30, wherein the predetermined open threshold and closed threshold correspond to the pressure in the isolation volume acting on the first barrier. 36. The container adapter according to Embodiment 35, which is dependent on Embodiment 3, wherein the predetermined open threshold and closed threshold correspond to the pressure in the isolation volume acting on the second container-facing surface of the first barrier. 37. The container adapter according to Embodiment 30 or any one of Embodiments 31 to 36 dependent on Embodiment 30, wherein the predetermined opening threshold is determined based on the degree of openness of at least the first barrier. 38. The container adapter according to Embodiment 31 or any one of Embodiments 32 to 37, if dependent on Embodiment 31, wherein the predetermined closure threshold is determined based on the degree of the tendency of at least the first barrier to close. 39. The predetermined release threshold is: The dimensions and / or shape of the aforementioned isolated volume section, The characteristics of the first barrier body include at least one of the following: the toughness of the main body material, the distribution of the main body material along at least the surface located on a plane transverse to an axis parallel to the direction of the fluid flow, and the orientation of the body with respect to the direction of the fluid flow. A container adapter according to Embodiment 37, which is dependent on Embodiment 3, determined based on one or more of the following: the contact area formed between the first barrier peripheral wall and the corresponding wall of the adapter. 40. The predetermined closing threshold is, The dimensions and / or shape of the aforementioned isolated volume section, The characteristics of the first barrier body include at least one of the elasticity of the body material, the distribution of the body material along at least a surface located on a plane transverse to an axis parallel to the direction of the fluid flow, and the orientation of the body with respect to the direction of the fluid flow. A container adapter according to Embodiment 38, which is dependent on Embodiment 3, determined based on at least one of the following: the first barrier peripheral wall and the contact area formed between the corresponding wall of the adapter. 41. The container adapter according to embodiment 39 or 40, wherein the contact formed in the contact area is at least a partially sealed contact. 42. The container adapter according to any one of embodiments 1 to 41, wherein the first barrier has an opening configured to open when the displacement is from the closed state to the open state and to re-close when the transition is from the closed state to the open state. 43. The container adapter according to Embodiment 42, which is dependent on Embodiment 3, wherein the opening is formed at least partially along the central portion of the first barrier body. 44. The container adapter according to Embodiment 42 or 43, dependent on Embodiment 3, wherein the first barrier body is arranged such that its dimensions increase along an axis parallel to the direction of the fluid flow, and as a result the increase in material begins at the opening and gradually increases laterally toward the peripheral wall. 45. The first barrier described above is A container adapter according to any one of embodiments 42 to 44, comprising a valve including a chamber that at least partially defines the isolated volume portion and the opening. 46. ​​The container adapter according to embodiment 45, wherein the valve includes one of the following: a duckbill-shaped valve, a dome-shaped valve, and a disc-shaped valve. 47. The container adapter according to Embodiment 45 or 46, as dependent on Embodiment 3, wherein the valve is formed with at least one projection extending laterally from the peripheral wall toward the corresponding adapter wall. 48. The container adapter according to any one of embodiments 45 to 47, which is dependent on Embodiment 3, wherein the chamber extends from the second container-facing surface and terminates in close proximity to the second barrier. 49. The container adapter according to Embodiment 48, which is dependent on Embodiment 11, wherein the chamber extends from the second container-facing surface and terminates near or adjacent to the distal surface of the partition wall. 50. The container adapter according to Embodiment 48, when dependent on Embodiment 11, wherein the chamber extends from the second container-facing surface and terminates near or adjacent to the proximal surface of the partition wall. 51. The container adapter according to Embodiment 11 or any one of Embodiments 12 to 44 if dependent on Embodiment 11, wherein the partition wall at least partially constitutes the first barrier, and the isolation volume portion is at least partially defined within a slit formed within the partition wall at least on the distal surface of the partition wall. 52. The container adapter according to Embodiment 51, wherein the slit terminates within the partition body between the proximal and distal surfaces of the partition, and the partition body is formed of a permeable material configured to receive a portion of the second container. 53. The container adapter according to Embodiment 51, wherein the slit extends from the distal surface of the partition wall to the proximal surface of the partition wall. 54. The container adapter according to any one of embodiments 1 to 44, wherein the first barrier comprises a bidirectional valve that is selectively displaceable between a closed state and an open state, which is operable to allow the flow of fluid through thereto from the first container to the second container in the said and opposite directions. 55. The container adapter according to Embodiment 3 or any one of Embodiments 4 to 54 dependent on Embodiment 3, wherein the second container-facing surface and the first container-facing surface are parallel to each other and further parallel to a plane that crosses an axis parallel to the direction of the fluid flow. 56. The container adapter according to Embodiment 55, which is dependent on Embodiment 42, wherein the distance along the parallel axis between the second container-facing surface and the first container-facing surface recedes near the opening. 57. A container adapter according to any one of embodiments 1 to 56, wherein at least a portion of the isolation volume is predetermined within the container adapter before at least the second container engages with the container adapter. 58. The container adapter according to any one of embodiments 1 to 57, wherein the container adapter is a vial adapter configured to be connected to a vial. 59. A method for transferring fluid between a first vessel and a second vessel associated with a fluid transfer conduit formed with a fluid port, the method being: To provide a container adapter connectable to the first container, the container adapter comprising: a fluid passage configured to facilitate the transfer of the fluid between the first container and the second container; a first barrier at least partially positioned within the fluid passage; and an isolation volume extending from the first barrier toward the second container, configured to communicate with the second container, and at least partially isolated from the first container during the transfer of the fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent the flow of fluid through it and an open state operable to allow the flow of fluid through it at least in a direction extending from the second container toward the first container, Positioning the fluid port within the isolated volume section, A method comprising discharging the fluid from the fluid port into the isolated volume section, thereby displacing the first barrier to its open state. 60. The container adapter constitutes a first container adapter that can be connected to the first container. The fluid port is removed from the isolated volume section of the first container adapter, The fluid port is positioned within the isolated volume section of a subsequent container adapter that can be connected to a subsequent first container, The method according to embodiment 59, further comprising discharging the fluid from the fluid port into the subsequent isolated volume section. 61. The method according to Embodiment 59 or 60, further comprising maintaining the fluid port entirely within the isolated volume during the fluid discharge from the fluid port into the isolated volume. 62. The method according to any one of embodiments 59 to 61, further comprising drawing the fluid from the first container into the second container through the first barrier. 63. The method according to embodiment 62, wherein the suction includes penetrating the fluid transfer conduit at least through the first barrier. 64. The method according to any one of embodiments 59 to 63, wherein providing the container adapter is provided, the method according to any one of claims 1 to 58. 65. A robotic system operable for transferring fluid between a first vessel and a second vessel having a fluid transfer conduit formed with a fluid port, wherein the first vessel is connectable to a vessel adapter, the vessel adapter comprising: a fluid passage configured to facilitate the transfer of the fluid between the first vessel and the second vessel; a first barrier at least partially positioned within the fluid passage; and an isolation volume extending from the first barrier toward the second vessel, configured to be in fluid communication with the second vessel, and at least partially isolated from the first vessel during the transfer of the fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent the flow of fluid through it and an open state operable to allow the flow of fluid through it at least in a direction extending from the second vessel toward the first vessel. The aforementioned system, Controller and The system comprises a manipulator that is controllable by the controller and configured to operate at least the second container, A robotic system in which the controller is configured to operate the manipulator to position the fluid port in the isolated volume section at a predetermined distance from at least the first barrier, and to maintain the fluid transfer conduit isolated from the first container during fluid transfer from at least the second container to the first container. 66. The container adapter constitutes a first container adapter that can be connected to the first container. The aforementioned manipulator, Remove the fluid port from the isolated volume section of the first container adapter, The fluid port is positioned within the isolated volume section of a subsequent container adapter that can be connected to a subsequent first container. The robot system according to embodiment 65, further comprising the controller configured to operate to discharge the fluid from the fluid port into the subsequent isolated volume section. 67. The robotic system according to embodiment 65 or 66, further comprising the controller being configured to operate the manipulator to maintain the fluid port entirely within the isolated volume during the fluid discharge from the fluid port into the isolated volume. 68. The robotic system according to any one of embodiments 65 to 67, further comprising the controller being configured to operate the manipulator to cause the suction of the fluid from the first container to the second container through the first barrier. 69. The robotic system according to embodiment 68, wherein the suction includes penetrating the fluid transfer conduit at least through the first barrier. [Brief explanation of the drawing]

[0060] To understand the present invention and how it can actually be implemented, embodiments will be described as non-limiting examples with reference to the accompanying drawings.

[0061] [Figure 1A] This is an illustrative block diagram of a fluid transfer system in a pharmaceutical preparation system according to one embodiment of the present disclosure, shown in a closed state. [Figure 1B] This is an illustrative block diagram of a fluid transfer system in a pharmaceutical preparation system according to one embodiment of the present disclosure, shown in an open state. [Figure 2] This is a schematic diagram of a fluid transfer system including a container adapter, according to one embodiment of the application of this disclosure, shown in a closed state. [Figure 3] This is a schematic diagram of an exemplary container adapter operably coupled to a container, according to one embodiment of the application of the present disclosure, shown in a closed state. [Figure 4A]This is a block diagram illustrating a fluid transfer system for a pharmaceutical preparation system according to one embodiment of the present disclosure, shown in a closed state. [Figure 4B] This is an illustrative block diagram of a robotic fluid transfer system for a robotic pharmaceutical preparation system according to one embodiment of the present disclosure, shown in a closed state. [Figure 5A] This is a cross-sectional view of a container adapter shown in a closed state according to one embodiment of the application of the present disclosure. [Figure 5B] This is a cross-sectional view of the valve element of the container adapter shown in Figure 5A, according to one embodiment of the application of the present disclosure. [Figure 6] This is a cross-sectional view of a container adapter according to one embodiment of the present disclosure, shown in a closed state. [Figure 7] This is a cross-sectional view of a container adapter according to one embodiment of the present disclosure, shown in an open state. [Figure 8A] This is a cross-sectional view of a container adapter shown in a closed state according to one embodiment of the application of the present disclosure. [Figure 8B] This is a perspective view of the valve element of the container adapter shown in Figure 8A, according to one embodiment of the application of the present disclosure. [Figure 8C] Figure 8B is a cross-sectional view according to one embodiment of the application of this disclosure. [Figure 9] This is a cross-sectional view of a container adapter according to one embodiment of the present disclosure, shown in a closed state. [Modes for carrying out the invention]

[0062] The following detailed description provides general and specific details regarding the features of the adapter according to various aspects and embodiments of the subject matter of this disclosure.

[0063] Refer to Figures 1A and 1B, which are block diagrams of the fluid transfer system 10. The fluid transfer system 10 comprises a first container 12 and a second container 14 arranged toward each other to facilitate the flow of fluid 16 in a fluid channel 18 between the first container 12 and the second container 14. In some embodiments, in order to prevent, or at least minimize, cross-contamination and / or microbial intrusion between the first container 12 and the second container 14, the fluid transfer system 10 includes an isolation volume section 20 configured to be in fluid communication with one of the first container 12 and the second container 14 and to be fluidly isolated from the other container.

[0064] The isolated volume section 20 may be housed in any preferred part of the system 10, such as the isolated volume section containing section 22, which may be located within the first container 12, the second container 14, and / or together with the container adapter 120 (Figure 3).

[0065] The isolation volume 20 extends from a first barrier 24 that is at least partially located within the fluid channel 18. The first barrier 24 is configured to be selectively displaceable between a closed state (Figure 1A) that can operate to prevent fluid flow through it and an open state (Figure 1B) that can operate to allow fluid flow through it.

[0066] In some embodiments, the fluid flows from at least the second container 14 to the first container 12, and the isolation volume section 20 extends from the first barrier 24 toward the second container 14 and is isolated from the first container 12.

[0067] The first barrier 24 is configured to divide the fluid flow path into an isolated volume section 20 and an exposed volume section 28. The exposed volume section 28 extends from the first barrier 24 and is configured to be fluidly exposed to and in fluidic communication with one of the first and second containers, which is isolated from the isolated volume section 20. In some embodiments, for example as shown herein, the exposed volume section 28 extends from the first barrier 24 toward the first container 12, is exposed to and in fluidic communication with the first container 12.

[0068] As shown in Figure 1A, in the closed state, the first barrier 24 prevents the flow of fluid from at least the isolated volume section 20 to the exposed volume section 28, and in the open state, as shown in Figure 1B, the first barrier 24 allows the fluid to flow from the isolated volume section 20 to at least the exposed volume section 28, and the exposed volume section 28 may comprise the first container 12 or be in fluid communication with the first container 12.

[0069] As shown in Figure 2, in some embodiments, the fluid 16 is introduced into the isolated volume 20 by a fluid transfer conduit 30 formed with a fluid port 32 for releasing the fluid therefrom. The fluid transfer conduit 30 is in fluid communication with the second vessel 14 and, in some embodiments, is physically connected to the second vessel 14. The first barrier 24 is selectively displaceable between a closed state, which is operable to prevent the flow of fluid through it, and an open state, which is operable to allow at least fluid to flow in the direction extending from the second vessel 14 to the first vessel 12, as indicated by arrow X1 in Figure 1B.

[0070] Referring to Figure 3, it can be seen that in some embodiments, the first barrier 24 is located in a container adapter 120 that can be connected to the first container 12. The container adapter 120 comprises at least a portion of the fluid channel 18, and the first barrier 24 is located within the fluid channel 18. The container adapter 120 may comprise at least a portion of the isolation volume 20.

[0071] It should be noted that in some embodiments, the container adapter 120 may be connectable to the second container 14.

[0072] It should be further noted that in some embodiments, the isolation volume section 20 may be located outside the container adapter 120, such as inside the first container 12 or the second container 14.

[0073] In some embodiments, the container adapter 120 may include at least a portion of the exposed volume 28, the portion of which extends within the container adapter 120 distal to the first barrier 24 along the longitudinal axis L1 of the container adapter 120.

[0074] It should be noted that in some embodiments, the exposed volume portion 28 may be located outside the container adapter 120, such as inside the first container 12 or the second container 14.

[0075] The container adapter 120 comprises a proximal end portion 132 and a distal end portion 134, extending distally from the proximal end portion 132 toward the first container 12 at least partially along the longitudinal axis L1.

[0076] In some embodiments, when the container adapter 120 is held by the user to connect to the first container 12, the proximal end portion 132 is closer to the user than the distal end portion 134. In other words, the distal end portion 134 is closer to the first container 12 than the proximal end portion 132. Therefore, the distal end portion 134, which extends distally from the proximal end portion 132, is understood to extend toward the first container 12.

[0077] The container adapter 120 is configured in any preferred shape, for example, as shown in Figures 5A to 9, where the proximal end portion 132 comprises an elongated shaft 135 extending distally to the disk-shaped portion. In some embodiments, the container adapter 120 comprises a partition wall 152 located at the proximal end portion 132 or at any other preferred location. The container adapter 120 may comprise a spike 136 extending distally from the disk-shaped portion and configured to penetrate a partition wall (not shown) of the first container 12 during connection between the container adapter 120 and the first container 12. The spike 136 may comprise a liquid channel for transferring liquid. In some embodiments, the spike 136 may further comprise an air channel for transferring air.

[0078] The container adapter 120 is formed with mounting means 138 for connecting to the first container 12. The mounting means 138 may be formed on the distal end portion 134 or at any other preferred location for connecting to the first container 12.

[0079] The container adapter 120 includes an internal portion 140 extending between a proximal end portion 132 and a distal end portion 134. The fluid channel 18 extends at least partially within the internal portion 140 along the longitudinal axis L1.

[0080] The first barrier 24 is positioned at any suitable location within the fluid channel 18. In some embodiments, the first barrier 24 is positioned in the fluid channel 18 midway between the proximal end portion 132 and the distal end portion 134. In some embodiments, the first barrier 24 is positioned in the fluid channel 18 closer to the proximal end portion 132 than to the distal end portion 134. In some embodiments, the first barrier 24 is positioned in the fluid channel 18 closer to the distal end portion 134 than to the proximal end portion 132.

[0081] In some embodiments, the first barrier 24 is located on the distal end surface 141 of the distal end portion 134 of the container adapter 120.

[0082] As shown in Figure 3, the first barrier 24 can be formed in any preferred manner having a body 142 having a surface 144 (first container-facing surface) facing the first container and a surface (second container-facing surface) 146 facing the second container. In some embodiments, the first container-facing surface 144 extends distally from the second container-facing surface 146 along the longitudinal axis L1. The body 142 further comprises a peripheral wall 148 extending from the first container-facing surface 144 to the second container-facing surface 146.

[0083] In some embodiments, the fluid transfer system 10 includes a second barrier 150 positioned at least partially within the fluid flow path 18. The second barrier 150 defines an isolation volume 20 that at least partially extends between the first barrier 24 and at least a portion of the second barrier 150. As seen in the embodiments shown in Figures 3 to 9, the second barrier 150 is located within the container adapter 120, but in some embodiments, it is understood that the second barrier 150 may be located within the first container 12 or the second container 14.

[0084] The second barrier 150 may comprise a partition wall 152 or at least a portion of the partition wall 152. The partition wall 152 is formed with a partition wall body 154. The body 154 comprises a proximal partition wall surface 156 and a distal partition wall surface 158 extending distally from the proximal partition wall surface 156 along the longitudinal axis L1. The partition wall body 154 is formed with a peripheral partition wall 160 extending from the proximal partition wall surface 156 to the distal partition wall surface 158.

[0085] The partition wall 152 is located at any suitable location within the fluid transfer system 10. In some embodiments, the partition wall 152 is located at least partially within the container adapter 120 in the adapter proximal end portion 132, for example, as shown in Figure 3.

[0086] In some embodiments, the first barrier 24 is located distal to the proximal partition surface 154 along the longitudinal axis L1. As described herein, a portion or the entirety of the partition 152 may constitute the second barrier 150. In some embodiments, as shown in Figure 5A, the distal partition surface 158 constitutes at least a portion of the second barrier 150. In some embodiments, the proximal partition surface 156 constitutes at least a portion of the second barrier 150.

[0087] Providing a second barrier 150 to the fluid transfer system 10 allows for improved sealing of the isolated volume section 20 when the isolated volume section 20 extends between the first barrier 24 and the second barrier 150.

[0088] Furthermore, forming a container adapter 120 having a second barrier 150 facilitates the formation of an isolated volume section 20 between the first barrier 24 and the second barrier 150.

[0089] In some embodiments, the partition wall 152 may be formed of an elastic, pierceable material configured to allow a fluid transfer conduit 30 to be penetrated once or repeatedly by a needle. The pierceable material of the partition wall 152 can further reduce cross-contamination and / or microbial intrusion by cleaning the fluid transfer conduit 30 when penetrating the partition wall material, before introducing the fluid transfer conduit 30 into the isolation volume section 20, and in some embodiments, while removing the fluid transfer conduit 30 from the isolation volume section 20. Furthermore, structuring the first barrier 24 having an opening 170 (Figures 5A to 9) that is operable to selectively and repeatedly transition from a closed state to an open state and return to a closed state allows the same fluid transfer conduit 30 to be used repeatedly to transfer fluid to multiple subsequent first containers.

[0090] A particular feature of this application is that, in some embodiments, at least a portion of the isolation volume 20 is already defined within the container adapter before the engagement of the second container 14 with the first container 12. That is, the isolation volume 20 is not created by the engagement of the first container 12 with the second container 14, but rather the isolation volume 20 is already defined within the container adapter 120 before the engagement of the first container 12 with the second container 14. Thus, the isolation volume 20 is formed within the container adapter 120 regardless of the degree of the sealed connection between the first container 12 with the second container 14 and / or the degree of the sealed connection between the container adapter 120 and the second container 14.

[0091] According to one embodiment of the present application, the operation of the fluid transfer system 10 can be carried out in any preferred sequence or method. In some embodiments, the fluid port 32 (Figure 2) of the fluid transfer conduit 30 associated with the second vessel 14 is introduced into the isolation volume section 20. The fluid 16 is then discharged from the fluid port 32 into the isolation volume section 20 and held in the isolation volume section 20 while closed. In some embodiments, the fluid transfer conduit 30 is positioned entirely within the isolation volume section 20 during the discharge of fluid therefrom, thereby isolating the second vessel 14 from the first vessel 12, at least during the transfer of the fluid 16.

[0092] The isolation volume section 20 is filled with discharged fluid until a predetermined opening threshold is reached, and the first barrier 24 is prompted to transition from a closed state, which prevents the flow of fluid from the isolation volume section 20, to an open state. In the open state, the flow of fluid from the isolation volume section 20 is permitted at least in the direction X1 extending from the isolation volume section 20 to the first container 12.

[0093] In non-limiting embodiments, the fluid transfer system 10 includes a dilution system for diluting substances, solids, and / or liquids in a vial. The vial may constitute a first container 12, and a syringe may constitute a second container 14. The fluid transfer conduit 30 includes a needle formed therefrom with a port 32 for releasing fluid into an isolated volume section 20. The fluid includes a diluent that is inserted into the syringe in any preferred manner, such as from an IV bag or any other container containing a diluent.

[0094] As shown in Figure 4A, the fluid transfer system 10 and its operation facilitate the uncontaminated and repetitive transfer of fluid from the fluid port 32 into a plurality of first vessels 12, for example, into the first first vessel 12A connected to the first vessel adapter 120A, and then to a subsequent first vessel 12B connected to the subsequent vessel adapter 120B, while isolating the fluid transfer conduit 30 from both the first and subsequent first vessels 12A and 12B, respectively.

[0095] First, the initial container 12A is filled with fluid from the second container 14 via the fluid transfer conduit 30, as described herein. That is, the fluid is discharged into the isolated volume section 20A of the initial container adapter 120A, selectively allowing the fluid to flow from the isolated volume section 20A to the initial container 12A through the first barrier 24A into the exposed volume section 28A.

[0096] Subsequently, the fluid transfer conduit 30 is removed from the isolated volume section 20A of the first container adapter 120A. Either immediately afterward or after a long period of time, the same fluid transfer conduit 30 is then introduced into the isolated volume section 20B of the subsequent container adapter 120B. Fluid from the second container 14 is discharged from the fluid port 32 into the subsequent isolated volume section 20B. As described with reference to the first container 12A, the subsequent first container 12B then receives fluid from the second container 14 via the fluid transfer conduit 30, i.e., discharges the fluid into the isolated volume section 20B of the subsequent container adapter 120B, selectively allowing the fluid to flow from the isolated volume section 20B to the subsequent first container 12B through the first barrier 24B into the exposed volume section 28B.

[0097] Therefore, the same fluid transfer conduit 30 associated with the same second container 14 can be repeatedly used to transfer fluid to multiple subsequent first containers, while preventing or minimizing cross-contamination and / or microbial intrusion, thanks to the isolation of the fluid transfer conduit 30 from the first container 12 by the first barrier.

[0098] Repetitive fluid transfer can be employed in a system for reducing cross-contamination of substances in at least a first vial and subsequent vials, by discharging a diluent fluid from a fluid port 32 of a fluid transfer conduit 30 including a needle associated with a syringe. First, the first vial is filled with fluid from the syringe via the needle, as described herein. That is, the fluid is discharged into the isolated volume section 20A of the first vial adapter, selectively allowing the fluid to flow from the isolated volume section 20A into the exposed volume section 28A relative to the first vial.

[0099] Subsequently, the needle is removed from the isolation volume section 20A of the first vial adapter. Either immediately afterward or after a long period of time, the same needle is then positioned in the isolation volume section 20B of a subsequent vial adapter, which is subsequently connected to a subsequent vial. Fluid from the syringe is discharged from the fluid port 32 into the subsequent isolation volume section 20B. As described with reference to the first vial, the subsequent vial is filled with fluid from the syringe via the fluid transfer conduit 30, i.e., the fluid is discharged into the isolation volume section 20B of the subsequent vial adapter, selectively allowing the fluid to flow from the isolation volume section 20B into the exposed volume section 28B of the subsequent vial.

[0100] As shown in Figures 1A to 4B, according to one embodiment of the present application, the fluid transfer system and its operation facilitate needle-free inflow from the isolation volume section 20 to the first container 12. For example, when the fluid transfer system includes a dilution system, as described, and the fluid transfer conduit includes a needle associated with a syringe, the fluid is first discharged into the isolation volume section from the needle port and then unnecessarily flows from the isolation volume section 20 into the vial by flowing through the opening 170 (Figure 5A) of the first barrier.

[0101] In some embodiments, fluid transfer may be performed manually.

[0102] As illustrated with reference to Figure 4B, in some embodiments, at least a portion of the fluid transfer may be performed automatically by a robotic system 162 that can operate to transfer fluid between, for example, a first vessel 12 and a second vessel 14. The robotic system 162 comprises a controller 164 and a manipulator 166 that is controllable by the controller 162 and configured to operate at least the second vessel 14. The controller 162 is configured to operate the manipulator 166 to position the fluid port 32 in the isolated volume section 20 at a predetermined distance Y1 from at least the first barrier 24 and to maintain the fluid transfer conduit 30 isolated from the first vessel 12 during the fluid transfer from at least the second vessel 14 to the first vessel 12.

[0103] The use of a manipulator 166, partially or fully automatically controlled by a controller 162, provides increased precision when positioning the end portion 168 of the fluid transfer conduit 30, including the fluid port 32, within the isolation volume 20 at a predetermined distance Y1. Precise positioning of the end portion 168 may be particularly important when the isolation volume 20 is relatively small relative to the entire fluid transfer conduit 30, and the end portion 168 must be confined within the isolation volume 20. In a non-limiting embodiment, the isolation volume 20 is formed with a height of about 4 millimeters, and the end portion 168 is inserted into the isolation volume 20 within a range of about 2 to 2.5 millimeters at a distance Y1 of about 1.5 to 2 millimeters from the first barrier 24.

[0104] Furthermore, the manipulator 166 is configured to instruct the fluid transfer conduit 30 to penetrate at least a portion, or even the entire, of the second barrier 150, so that the end portion 168 can reach the isolation volume 20.

[0105] In some embodiments, the robot system 162 includes a drive actuator configured to actuate the movement of the manipulator 166. In non-limiting embodiments, the drive actuator may include any one of the following mechanical actuators: a motor, a direct linear motor, a servo motor, a hydraulic motor, a pneumatic motor, an electric motor, a magnetic motor, a spring, a piston, and / or a combination thereof.

[0106] In some embodiments, the robot system 162 may further include sensors 180 such as optical sensors, for example, a camera and / or encoders (such as an encoder on any one of the motors), or any other type of magnetic sensor, vibration sensor, acceleration sensor, audio sensor, electrical sensor, or any sensor configured to guide a drive assembly for performing the movement of the manipulator 166 in order to position the fluid transfer conduit 30 within the isolated volume section 20, or sensors configured to detect information relating to the container adapter 120, one or more of the first container 12 and the second container 14.

[0107] In some embodiments, the manipulator 166 is configured to draw fluid from the first container 12 into the second container 14 through the first barrier 24. The manipulator 166 moves the fluid transfer conduit 30 to puncture and penetrate the first barrier 24, and then positions the fluid port 32 in the exposed volume section 28 to draw fluid from the first container 12. Alternatively, or additionally, the suction may be carried out by the use of a bidirectional first barrier, as described with reference to Figures 8A-8C.

[0108] In some embodiments, the robotic system 162 includes a robotic pharmaceutical preparation system configured to transport pharmaceuticals for preparation.

[0109] Referring to any one of the embodiments in Figures 1A to 9, it will be understood that the container adapter 120 may be configured to connect to the second container 14 and may be formed as a syringe connector or any other type of connector. The syringe connector has features described with reference to mounting means configured to attach to the container adapter 120 and the syringe 102.

[0110] In some embodiments, the container adapter is configured to facilitate fluid flow from at least the first container 12 to the second container 14, and it is further understood that the isolation volume 20 extends from the first barrier 24 toward the first container 12 and is isolated from the second container 14. The exposed volume 28 extends from the first barrier 24 toward the second container 14, is exposed to the second container 14, and is in fluid communication with the second container 14. The first barrier 24 is configured to be selectively displaceable between a closed state that can be operated to prevent fluid flow through it and an open state that can be operated to allow fluid flow through it in a direction extending at least from the first container 12 to the second container 14.

[0111] In a non-limiting embodiment, the fluid transfer system 10 includes a suction system for drawing liquid from a vial that may constitute a first container 12 to a syringe that may constitute a second container 14, via a fluid transfer conduit 30 including a needle formed with a port 32. The liquid is typically a diluted substance. Suction may be performed by puncturing a first barrier 24 with the needle to access the fluid in the vial. Alternatively, or additionally, suction may be performed by using a bidirectional first barrier, as described with reference to Figures 8A–8C.

[0112] Refer to Figures 5A to 9, which are embodiments of the exemplary container adapter 120 described with reference to Figures 1A to 4B. The first barrier 24 is configured as a valve 200 or a part of a valve 200 and comprises a chamber 210 that at least partially defines the isolation volume 20 and is configured to receive a fluid transfer conduit 30 (Figure 2) therein. The first barrier 24 is formed with an opening 170 configured to open when transitioning from a closed state to an open state and to reclose when transitioning from a closed state to an open state. In some embodiments, the isolation volume 20 and / or at least a part of the first barrier 24 constitute the valve 200.

[0113] In some embodiments, the opening 170 extends at least partially or completely through the first barrier body 142 from the first container-facing surface 144 (Figure 3) to the second container-facing surface 146. The opening 170 may be located in the central portion 172 of the first barrier 24 (i.e., the opening 170 and the portion surrounding the opening 170) or at any other location therein. In the embodiments of Figures 5A-6, 8, and 9, the opening is configured as a slit 218 (Figure 5B), while the opening 170 is configured as an orifice 220 in the embodiment of Figure 7.

[0114] Referring to all embodiments described herein, the opening 170 is configured to transition between a closed state and an open state in response to any preferred prompt, for example, a mechanical force.

[0115] In some embodiments, such as when the first barrier 24 includes a valve 200, the first barrier 24 is configured to displace from a closed state to an open state in response to a pressure difference applied across it. The pressure difference, indicated by arrow 222 in Figure 5A, can be applied across the first barrier 24 in the direction of fluid flow X1 (Figure 1B) during fluid transfer, and is generally parallel to the longitudinal axis L1. Alternatively, the pressure difference can be applied at an angle to the longitudinal axis L1.

[0116] The first barrier 24 is configured to displace from a closed state to an open state when the pressure inside the isolation volume 20 increases above a predetermined open pressure threshold. Similarly, the first barrier 24 may be configured to displace from an open state to a closed state when the pressure inside the isolation volume 20 decreases below a predetermined closing threshold.

[0117] It should be noted that a predetermined opening pressure threshold may be referred to as the cracking pressure, i.e., the pressure that causes the opening 170 to "crack open," and a predetermined closing pressure threshold may be referred to as the resealing pressure, i.e., the pressure that causes the opening 170 to reseal.

[0118] An increase and / or decrease in pressure may be due to the fluid being discharged into the isolated volume section 20 by the second vessel. In some embodiments, as the liquid fills the isolated volume section 20, pressure is applied to the second vessel-facing surface 146 (Figure 3) until, in a non-limiting embodiment, a predetermined opening threshold is reached when the isolated volume section 20 is filled to a large extent with fluid, and when more than 50% of the isolated volume section 20 is filled with fluid. Thus, the opening 170 is typically opened toward the first vessel 12, encouraging the fluid to flow from the isolated volume section 20 to the exposed volume section 28.

[0119] When a predetermined closing threshold is reached, the opening 170 re-closes and returns to the closed state. In a non-limiting embodiment, the predetermined closing threshold is reached when at least almost all of the fluid has been discharged from the isolation volume section 20, for example, when less than 50% of its volume, or less than 25% of its volume, or less than 10% of its volume, or less than 5% of its volume, or less than 1% of its volume, or less than 0.1% of its volume, or less than 0.01% of its volume.

[0120] Additionally, or alternatively, the fluid transfer conduit 30 applies a thrust to the first barrier 24 when discharging fluid from the first barrier 24, increasing the pressure until a predetermined opening threshold is reached. Thus, the opening 170 is typically encouraged to open toward the first vessel 12, allowing fluid to flow from the isolated volume section 20 to the exposed volume section 28. When the discharge of fluid from the fluid transfer conduit 30 stops, the pressure in the isolated volume section decreases. Upon reaching a predetermined closing threshold, the opening 170 re-closes, returning to a closed state.

[0121] The predetermined opening threshold and predetermined closing threshold may be the same or different. In some embodiments, the predetermined opening threshold and predetermined closing threshold are the same. In some embodiments, the predetermined closing threshold is less than 0.1 bar, slightly lower than the predetermined opening threshold, in non-limiting embodiments.

[0122] In some embodiments, a predetermined closing threshold is significantly smaller than a predetermined opening threshold. Therefore, the first barrier 24 is configured to transition from a closed state to an open state at a predetermined opening threshold pressure, and when the pressure drops to the predetermined closing threshold pressure, the first barrier 24 is configured to return from the open state to a closed state.

[0123] In a non-limiting embodiment, when the fluid transfer system 10 includes a dilution system, the fluid discharged into the isolated volume section 20 of the vial adapter may be a diluent. The diluent may be discharged from the needle port of a syringe. When the diluent fills the isolated volume section 20 in its closed state, the pressure on the first barrier 24 increases. When the pressure in the isolated volume section 20 reaches a predetermined opening threshold, the opening 170 transitions to its open state, and the diluent flows into an exposed volume section 28, typically defined within the vial.

[0124] According to some embodiments, a predetermined opening threshold is a measure of pressure and is determined in any preferred manner. In some embodiments, the predetermined opening threshold is determined based on the degree of openness of at least the first barrier 24, i.e., the tendency of the first barrier 24 to transition from a closed state to an open state when pressure is applied thereto.

[0125] The degree of openness of the first barrier 24 may depend on one or more properties of the isolation volume section 20 and / or the first barrier 24.

[0126] In some embodiments, the characteristics may include the dimensions and / or shape of the isolation volume 20. For example, the pressure in a smaller isolation volume 20 increases more rapidly than the pressure in a larger isolation volume 20, causing the first barrier 24 to transition more quickly from a closed state to an open state when communicating with the smaller isolation volume 20.

[0127] In some embodiments, the properties may include the degree of toughness of the first barrier body material, which can be defined as the material's ability to withstand a load or pressure applied thereon. For example, a harder material, i.e., a material with a higher ability to withstand the pressure applied thereon, and typically having higher hardness and / or higher ductility, will result in lower openness. As a result, the first barrier 24 will transition from a closed state to an open state at a slower rate than a material with a lower degree of toughness.

[0128] In some embodiments, the characteristics may include the distribution of the first barrier body material along at least the transverse axis L2. For example, in the case of a first barrier 24 with an opening 170 located in the center, a smaller amount of material toward the central portion 172 of the first barrier 24 along the transverse axis L2 increases its openness compared to a first barrier 24 having a larger amount of material in the central portion 172.

[0129] In some embodiments, the characteristics may include the orientation of the first barrier body 142 with respect to the direction of the fluid flow X1 (Figure 1B). For example, as shown in Figure 5A, if the first barrier body 142 in the central portion 172 is generally convex, and thereby expands in the direction of the fluid flow X1, the opening 170 opens more readily in the same direction, allowing the fluid to flow through it. This is in comparison to the first barrier body, where the first barrier body is generally concave, and thereby expands in the central portion 172 opposite to the direction of the fluid flow X1, or is generally flat, and therefore the opening 170 does not open as readily in the direction of the flow X1.

[0130] In some embodiments, the characteristics may include the size of the contact area 230 formed between the first barrier peripheral wall 148 and the corresponding wall 232 of the internal portion 140 of the container adapter 120. In some embodiments, the corresponding wall 232 presses the first barrier peripheral wall 148 in the contact area 230, thereby applying an inward force F1 in orientation along the lateral axis L2, i.e., the force F1 is applied inward toward the central portion 176. The force F1 encourages the opening 170 to remain closed. Thus, a larger contact area 230 and a greater degree of sealing between the first barrier peripheral wall 148 and the corresponding wall 232 result in a larger inward force F1. A larger inward force F1 increases the resistance to the transition of the opening 170 from closed to open.

[0131] In some embodiments, a predetermined closing threshold is a measure of pressure and is determined by any preferred method. In some embodiments, the predetermined closing threshold is determined based on the tendency of the first barrier 24 to transition from an open state to a closed state.

[0132] The tendency of the first barrier 24 to close may depend on one or more properties of the isolation volume section 20 and / or the first barrier 24.

[0133] In some embodiments, the characteristics may include the dimensions and / or shape of the isolation volume 20. For example, the pressure in a smaller isolation volume 20 increases more rapidly than the pressure in a larger isolation volume 20, causing the first barrier 24 to transition from an open state to a closed state more slowly when communicating with the smaller isolation volume 20.

[0134] In some embodiments, the properties may include the degree of elasticity of the main material, which can be defined as the ability of the material to return to its original state before pressure is applied to it. For example, a more elastic material will have a greater tendency to close. As a result, the first barrier 24 will transition from an open state to a closed state at a faster rate than a less elastic material.

[0135] In some embodiments, the characteristics may include the distribution of the first barrier body material along at least the transverse axis L2. For example, in the case of a first barrier 24 with the opening 170 located in the center, a larger amount of material toward the central portion 172 of the first barrier 24 along the transverse axis L2 increases the tendency to close compared to a first barrier 24 having less material toward the central portion 172.

[0136] In some embodiments, the characteristics may include the orientation of the first barrier body 142 with respect to the direction of the fluid flow X1. For example, when the first barrier body in the central portion 172 is configured to expand concavely opposite to or away from the direction of the fluid flow X1, or without an expanding portion, the opening 170 remains more easily closed, at least in the direction of the fluid flow X1, thereby preventing fluid flow through it.

[0137] In some embodiments, the characteristics may include the size of the contact area 230. For example, a larger contact area 230 and a greater degree of sealing between the first barrier peripheral wall 148 and the corresponding wall 232 result in a greater internal force F1. A greater internal force F1 increases the tendency of the first barrier 24 to remain closed and / or to transition from an open state to a closed state.

[0138] As described herein, the first barrier 24 and / or valve 200 may be any preferred structure configured to transition between an open state and a closed state. Figures 5A to 9 show some exemplary embodiments of different types of the first barrier 24, also referred to herein as valves.

[0139] As shown in Figures 5A to 6, the first barrier body 24 is arranged to start from the opening 170 and increase along the lateral axis L2, where the thickness of the body is relatively thin and increases as the body extends laterally toward the peripheral wall 148. As described herein, this structure enhances the degree of openness of the valve 200.

[0140] The opening 170 is shown to be formed as a slit 218 formed in the central portion 172 of the valve 200.

[0141] In some embodiments, the chamber 210 is configured to extend from the second container-facing surface 144 (Figure 3), as shown in Figures 5A and 6, and to terminate at and / or near the distal partition surface 158.

[0142] It should be noted that in some embodiments, the chamber 210 is configured to extend from the second container-facing surface 144 and terminate at and / or in close proximity to the partition proximal surface 156.

[0143] In the embodiments shown in Figures 5A to 6, the first barrier 24 is at least partially defined by the valve 200, or by a portion of the valve including at least the central portion 172. The second barrier 150 is at least partially defined by the partition 152, or by at least the distal surface 158 of the partition. In the embodiments shown in Figures 5A and 5B, the valve 200 is configured similarly to a dome-shaped valve, and in the embodiment shown in Figure 6, the valve 200 is configured similarly to a duckbill-shaped valve.

[0144] The valve 200 may be positioned within the container adapter 120 at any preferred location and may be connected to the container adapter 120 in any preferred manner. In some embodiments, the valve 200 may be formed with a flange 240 (Figure 5B) with an overhang grip 242 configured to be fitted into a corresponding structure 250 (Figure 6) formed to receive the flange 240.

[0145] The valve 200 may be formed with at least one projection 252 projecting laterally from the peripheral wall 148. The projection 252 may be configured to extend toward the corresponding wall 232 of the container adapter 120 and may function as the aforementioned contact area 230. The projection 252 may project from any location along the peripheral wall 148, such as a location aligned with the opening 170 along the lateral axis L2. The projection 252 may be configured to be pressable inward by the corresponding wall 232 toward the opening 170 in the orientation of a force F1 in order to maintain the opening 170 in a closed state until a predetermined opening threshold is reached. When the predetermined opening threshold is reached, the projection 252 is pushed laterally toward the wall 232 corresponding to the adapter, allowing the opening 170 to transition from a closed state to an open state.

[0146] As shown in Figure 7, the valve 200 may be integrally formed within the partition wall 152. In one such embodiment, the chamber 210 is located within the partition wall 152, and the isolation volume 20 includes the chamber 210 and extends toward the proximal surface 156 of the partition wall. The opening 170, formed as an orifice 220, extends from the chamber 210 to the distal surface 158 of the partition wall. The exposed volume 28 extends from the distal surface 158 of the partition wall within the interior 140 of the container adapter 120 toward the first container 12.

[0147] In some embodiments, the partition wall 152 is configured with a punctureable material that allows a fluid transfer conduit associated with the second container 14, such as a needle associated with a syringe, to penetrate the partition wall 152 and position a fluid port 32 (Figure 2) in or near the chamber 210 to discharge fluid into the chamber 210.

[0148] In the embodiment shown in Figure 7, the first barrier 24 is at least partially defined by the bottom surface 254 of the chamber 210. The second barrier 150 is at least partially defined by the top surface 256 of the chamber 210.

[0149] In some embodiments, the partition wall 152 is formed with one or more projections 252 that function as the aforementioned contact area 230, as described with reference to the projections 252 shown in Figures 5A to 6.

[0150] As described, the first barrier 24 shown in Figures 5A–7 can be deployed for dilution within the dilution system. During dilution, a fluid transfer conduit 30, for example, a needle associated with a syringe, is inserted into the isolation volume section 20 while transferring the diluent from the fluid port 32 into the vial via the opening 170. The diluent is transferred needleless, i.e., through the first barrier 24 without the needle passing through the opening 170. As described, the separation of the needle from the vial facilitates the repeated use of the needle for diluting substances in multiple vials, minimizing or eliminating the risk of cross-contamination and / or microbial entry. The valve 200 shown in Figures 5A–7 is configured convex, i.e., biased to open toward the vial. The convex structure allows the fluid to flow from the syringe into the vial while open and resist the opening in the opposite direction, thereby preventing the fluid from being inadvertently transferred from the vial into the isolation volume section 20.

[0151] Aspiration may be performed to remove the diluted substance from the vial by puncturing the needle through the valve 200 at the opening 170, or by puncturing the needle at any other suitable location through the surface 144 facing the container and the second surface 144 facing the container, and entering the exposed volume section 28. During aspiration, since the needle may be a single-use disposable needle, in some embodiments, though not all, fewer precautions may be required to prevent cross-contamination.

[0152] The valve 200 shown in Figures 5A to 7 is configured substantially as a unidirectional valve. In some embodiments, as shown in Figures 8A to 8C, the valve 200 may be configured as a bidirectional valve 280. The bidirectional valve 280 is selectively displaceable between a closed state and an open state, and is operable to allow fluid to flow through it in a direction extending from the first container to the second container and in the opposite direction. During operation, the bidirectional valve 280 is configured to open when transferring fluid from the second container 14 to the first container 12, such as during dilution from a syringe to a vial, and to open further when transferring fluid from the first container 12 to the second container 14, such as during aspirating the diluted pharmaceutical from the vial into a syringe.

[0153] As shown in Figures 8B and 8C, the bidirectional valve 280 may be of any preferred structure, such as a structure that is substantially symmetrical with respect to a central plane P that includes a lateral axis L2 and traverses a longitudinal axis L1, at least in part. The first barrier 24 may be formed with a second container-facing surface 146 and a first container-facing surface 144 that is further parallel to the central plane P with respect to the second container-facing surface. The central portion 172 surrounding the opening 170 is configured to be substantially symmetrical with respect to the central plane P, resulting in a bidirectional valve 280 that is biased substantially equally bidirectionally toward the first container 12 and the second container 14. In some embodiments, the first barrier 24 is formed such that the distance along the longitudinal axis L1 between the second container-facing surface 146 and the first container-facing surface 144 recedes in the central portion 172. Thus, the opening 170 defined by the thinnest part of the first barrier 24 transitions easily from a closed state to an open state, and vice versa.

[0154] In the bidirectional valve 280, the first barrier 24 is defined at least partially, or at least partially, by the bidirectional valve 280. The second barrier 150 is defined at least partially by the partition wall 152, or at least by the distal surface 158 of the partition wall.

[0155] The bidirectional valve 280 can be positioned at any suitable location along the fluid flow path 18, such as the bottom of the disc-shaped container adapter 120, as shown in Figure 8A. In some embodiments, the bidirectional valve may be positioned in the container adapter at the distal end portion 134.

[0156] An additional embodiment of the bidirectional valve is shown in Figure 9. In some embodiments, the distal surface 158 of the partition wall constitutes a first barrier 24, and the isolation volume 20 is at least partially defined within a slit 260 formed in the partition wall 152. The isolation volume 20 extends to a second barrier 150 that at least partially defines the proximal surface 156 of the partition wall. Note that in such an embodiment, the isolation volume is relatively small because it is formed within a slit 260 in the partition wall 152.

[0157] As shown in Figure 9, the slit 260 extends entirely through the partition body 154 from the proximal partition surface 156 to the distal partition surface 158. A fluid transfer conduit 30 (Figure 2), for example, a needle, can be inserted into the slit 260 and positioned between the proximal partition surface 156 and the distal partition surface 158. A portion of the slit 260 proximal to the distal partition surface 158 functions as an opening 170. In one such embodiment, the portion of the partition 152 including the uppermost end of the slit 260 constitutes a second barrier 150.

[0158] Alternatively, the slit 260 extends from the distal surface 158 of the partition wall and terminates within the partition wall body 154 between the proximal surface 156 and the distal surface 158 of the partition wall. In one such embodiment, the partition wall body 154 may be formed of a punctureable material configured to receive a fluid port 32, which can be punctured into the partition wall body 154 to form a fluid channel 18 for draining fluid from the fluid port 32 into the opening 170.

[0159] In the embodiment shown in Figure 9, the partition wall 160, which includes the first barrier wall 148, forms a contact area 230 with the corresponding wall 232 of the container adapter 120. As described herein, the corresponding wall 232 presses against at least a portion of the partition wall 160 in the contact area 230, thereby applying an internal force F1 (Figure 5A) in orientation along the lateral axis L2, causing the opening 170 to remain closed. When a predetermined opening threshold is reached, the partition wall 160 is pushed laterally against the corresponding wall 230, allowing the opening 170 to transition from a closed state to an open state.

[0160] In some embodiments, the partition body 154 may be formed with protrusions such as the projection 252 shown in Figure 7.

[0161] In Figures 5A to 9, the first barrier 24 and / or valve 200 are described as being located within a vial adapter, but it is understood that the first barrier 24 and / or valve 200 may be located within one or more adapters associated with the second container 14, such as a syringe adapter connectable to a syringe, within a syringe, or within any other container configured to transport fluid and / or elements that engage with it. In some embodiments, the first barrier 24 and / or valve 200 may be located within an IV bag or an adapter associated with an IV bag, such as a spike adapter or a tube associated with an IV bag.

[0162] While various embodiments of the present invention are described and illustrated herein, those skilled in the art will readily conceive of various other means, materials, or structures for performing the function, obtaining the result, or for one or more of the advantages described herein, and each such variation or modification will be considered within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are intended for illustrative purposes only, and that actual parameters, dimensions, materials, and configurations will depend on the specific application in which the teachings of the present invention are used. Those skilled in the art will be able to recognize or confirm many equivalents to specific embodiments of the present invention described herein by means of routine experimentation alone. Accordingly, it should be understood that the embodiments described herein are presented only as examples, and that embodiments of the present invention may be practiced separately from those specifically described and claimed within the appended claims, their equivalents, and any claims supported by this disclosure. The embodiments of the present invention in this disclosure cover each individual feature, system, article, material, composition, kit, method, and step described herein. In addition, any combination of two or more such features, systems, articles, materials, compositions, kits, methods, and steps is included within the scope of the present invention as long as such features, systems, articles, materials, compositions, kits, methods, and steps are not inconsistent with each other.

[0163] The embodiments disclosed herein may also be combined with one or more features, functionalities, or materials, as well as complete systems, devices, or methods, to bring about further embodiments and inventions. Furthermore, some embodiments may be distinguishable from the prior art by specifically lacking one and / or another feature disclosed in a particular prior art reference, i.e., the claims for some embodiments may be distinguishable from the prior art by including one or more negative limitations.

[0164] Furthermore, as described above, various inventive concepts can be embodied in one or more methods, and embodiments thereof are provided. The actions performed as part of a method can be ordered in any preferred manner. Therefore, although they are shown as a series of actions in the illustrative examples, embodiments can be constructed in which the actions are performed in a different order than those illustrated, which may include performing several actions simultaneously.

[0165] Any references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., presented anywhere in this application are incorporated herein by reference in their entirety. Furthermore, all definitions defined and used herein should be understood to govern dictionary definitions, definitions in documents incorporated by reference, and the ordinary meanings of the defined terms.

[0166] In this specification and in the claims, the indefinite terms "a" and "an" should be understood to mean "at least one" unless explicitly stated otherwise.

[0167] As used herein and in the claims, the phrase “and / or” should be understood to mean “either or both” of the elements thus combined, i.e., elements that are sometimes conjunctive and other times disjunctive. Any elements listed in “and / or” should be interpreted similarly, i.e., “one or more” of the elements thus combined. Other elements may exist at their discretion, whether related to those specifically identified elements or not, in addition to the elements specifically identified by the “and / or” clause. Thus, in non-restrictive embodiments, when used in combination with open-ended language such as “comprising,” in one embodiment, a reference to “A and / or B” may refer in only A (including elements other than B at their discretion), in another embodiment, a reference to only B (including elements other than A at their discretion), and in yet another embodiment, a reference to both A and B (including other elements at their discretion).

[0168] As used herein and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” should be interpreted as inclusive, that is, including at least one of multiple elements or lists of elements, but also including two or more, and optionally including additional unlisted items. Only terms that are explicitly indicated, such as “one of” or “exactly one of” or, when used in the claims, “consisting of,” refer to including exactly one element of multiple elements or lists of elements. In general, as used herein, the term “or” should be interpreted only as indicating an exclusive choice (i.e., “one or the other, but not both”) when preceded by terms of exclusivity such as “either,” “one of,” “one of,” or “exactly one of.” “Essentially consisting of” should have its usual meaning as used in the field of patent law when used in the claims.

[0169] As used herein and in the claims, the phrase “at least one” with respect to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of every element specifically enumerated in the list of elements, nor excluding any combination of elements in the list of elements. This definition also allows for the presence of elements other than those specifically identified in the list of elements referred to by the phrase “at least one,” whether or not they are related to those specifically identified elements, at the discretion of the user. Therefore, in non-limiting embodiments, "at least one of A and B" (or equivalently, "at least one of A or B," or equivalently, "at least one of A and / or B") may refer to, in one embodiment, at least one optionally comprising two or more A's and no B (optionally comprising elements other than B); in another embodiment, at least one optionally comprising two or more B's and no A (optionally comprising elements other than A); and in yet another embodiment, at least one optionally comprising two or more A's and at least one optionally comprising two or more B's (and optionally comprising other elements).

[0170] In the claims and in the above specification, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” and “composed of” should be understood to be open-ended, meaning that they include but are not limited to these. Only the transitional phrases “consist of” and “essentially become from” should be closed or semi-closed transitional phrases, respectively.

[0171] While various exemplary embodiments have been described in detail herein, many modifications are possible in the exemplary embodiments without substantially departing from the concepts of the Disclosure. Therefore, any such modifications are intended to be within the scope of the Disclosure. Similarly, while the Disclosure herein includes many specific combinations, these specific combinations should not be construed as limiting the scope of either the Disclosure or the Appendix Claims, but are provided as descriptions relating to one or more specific embodiments that may fall within the scope of the Disclosure and the Appendix Claims. Any described features from the various embodiments disclosed may be used in combination with other disclosed embodiments. In addition, other embodiments of the Disclosure may be conceived that fall within the scope of the Disclosure and the Appendix Claims.

[0172] This disclosure provides various examples, embodiments, and features that should be understood to be combinable with other examples, embodiments, or features described herein, unless expressly stated otherwise or mutually exclusive.

Claims

1. A container adapter connectable to the first container of a fluid transfer system for transferring fluid between the first and second containers of the fluid transfer system, wherein the adapter is A fluid channel configured to facilitate the transfer of the fluid between the first container and the second container, A first barrier positioned at least partially within the fluid channel, A second barrier positioned at least partially within the fluid flow path, The invention comprises an isolated volume section at least partially defined between the first barrier and at least a portion of the second barrier, configured to be in fluid communication with the second container, and at least partially isolated from the first container during the transfer of the fluid, A container adapter wherein the first barrier is selectively displaceable between a closed state that is operable to prevent the flow of fluid through it and an open state that is operable to allow the flow of fluid through it at least in a direction extending from the second container to the first container during the transfer of the fluid.

2. The aforementioned container adapter is The proximal end portion, When connected to the container adapter, the distal end portion extends distally from the proximal end portion toward the first container, at least partially along the longitudinal axis of the adapter, The container adapter according to claim 1, comprising an internal portion extending between the proximal end portion and the distal end portion, wherein the fluid flow path extends at least partially along the longitudinal axis within the internal portion.

3. The first barrier has a first barrier body, and the first barrier body is A first container-facing surface, configured to face at least partially toward the first container when connected to the container adapter, A second container-facing surface configured to face at least partially opposite to the first container-facing surface, The container adapter according to claim 1 or 2, further comprising: a first barrier peripheral wall extending from the first container-facing surface to the second container-facing surface.

4. The container adapter according to claim 2 or claim 3, as a result of claim 2, wherein the first barrier is located in the fluid flow path midway between the proximal end portion and the distal end portion.

5. The container adapter according to claim 4, wherein the first barrier is positioned in the fluid flow path closer to the proximal end portion than to the distal end portion.

6. The container adapter according to claim 4, wherein the first barrier is positioned in the fluid flow path closer to the distal end portion than to the proximal end portion.

7. The container adapter according to claim 2 or any one of claims 3 to 6 as dependent on claim 2, wherein the first barrier is configured to include a first barrier mounting element that can be attached to a corresponding adapter mounting element of the internal portion.

8. The container adapter according to claim 7, wherein the first barrier mounting element comprises a flange that can be attached to the corresponding adapter mounting element, and the corresponding adapter mounting element is formed with a recess configured to receive the flange.

9. The container adapter according to claim 3 or any one of claims 4 to 8, if dependent on claim 3, wherein the first barrier peripheral wall is configured to be attachable to the corresponding adapter wall of the container adapter.

10. The container adapter according to claim 9, as dependent on claim 2, wherein the corresponding adapter wall of the container adapter constitutes the wall of the internal portion.

11. The second barrier constitutes at least a portion of the partition wall, the partition wall having a partition wall body, the partition wall body is The proximal surface of the septum, A distal surface of the partition wall extending distally from the proximal surface of the partition wall along the longitudinal axis of the adapter, A container adapter according to any one of claims 1 to 10, comprising a peripheral wall of the partition wall extending between the proximal surface of the partition wall and the distal surface of the partition wall.

12. The container adapter according to claim 11, as dependent on claim 2, wherein the partition wall is at least partially located within the proximal end portion.

13. The container adapter according to claim 11 or 12, wherein the first barrier is disposed distally along the longitudinal axis from the proximal surface of the partition wall.

14. The container adapter according to any one of claims 11 to 13, wherein the distal surface of the partition wall at least partially constitutes the second barrier.

15. The container adapter according to any one of claims 11 to 13, wherein the proximal surface of the partition wall at least partially constitutes the second barrier.

16. The container according to claim 15, wherein the distal surface of the partition wall at least partially constitutes the first barrier, and the isolation volume extends at least partially between the proximal surface of the partition wall and the distal surface of the partition wall.

17. The container adapter according to any one of claims 11 to 16, wherein the first barrier is at least partially disposed within the partition body.

18. The container adapter according to any one of claims 11 to 17, wherein the partition wall is configured to be at least partially permeable by a fluid transfer conduit associated with the second container.

19. The container adapter according to claim 18, wherein the partition wall is configured to be repeatedly passable by the fluid transfer conduit at least when inserting the fluid transfer conduit into and removing it from the second barrier.

20. The container adapter according to any one of claims 1 to 19, wherein the isolation volume is configured to receive therein at least a portion of a fluid transfer conduit associated with the second container.

21. The container adapter according to any one of claims 1 to 20, wherein the isolation volume is configured to receive fluid discharged by a fluid transfer conduit associated with the second container and to hold the fluid therein while the first barrier is closed.

22. The container adapter according to any one of claims 1 to 21, wherein the first barrier is configured to allow needleless inflow of the fluid into the first container through thereto while the first barrier is open.

23. The container adapter according to any one of claims 1 to 22, wherein the first barrier includes a permeable material to allow a fluid transfer conduit associated with the second container to at least partially penetrate the first barrier to facilitate the suction of fluid from the first container to the second container.

24. The container adapter according to any one of claims 1 to 23, wherein the first barrier is configured to divide the fluid flow path into an isolated volume section and an exposed volume section, the exposed volume section extends distally from the first barrier and is exposed to the first container and in fluid communication with the first container when the first container is connected to the container adapter.

25. The container adapter according to claim 24, wherein at least a portion of the exposed volume extends distally from the first barrier within the container adapter.

26. The container adapter according to claim 24 or 25, wherein, in the open state, the first barrier allows fluid to flow at least from the isolated volume portion to the exposed volume portion.

27. The container adapter according to any one of claims 24 to 26, wherein in the closed state, the first barrier prevents the flow of fluid between the isolated volume and the exposed volume.

28. The container adapter according to any one of claims 1 to 27, wherein the first barrier is configured to displace from the closed state to the open state in response to a pressure difference applied across the first barrier.

29. The container adapter according to claim 28, wherein the pressure difference is applied in the direction of the fluid flow, with the first barrier in between during its transfer.

30. The container adapter according to claim 24 or any one of claims 25 to 29 as dependent on claim 24, wherein the first barrier is configured to displace from the closed state to the open state when the differential pressure between the isolated volume portion and the exposed volume portion increases beyond a predetermined open pressure threshold.

31. The container adapter according to claim 24 or any one of claims 25 to 30 as dependent on claim 24, wherein the first barrier is configured to displace from the open state to the closed state when the differential pressure between the isolated volume portion and the exposed volume portion decreases to a predetermined closing threshold.

32. The container adapter according to claim 31, in the case of claim 30, wherein the predetermined opening threshold and the predetermined closing threshold are the same.

33. The container adapter according to claim 31, in which the predetermined opening threshold and the predetermined closing threshold are different, as described in claim 30.

34. The container adapter according to claim 33, wherein the predetermined opening threshold is greater than the predetermined closing threshold.

35. The container adapter according to any one of claims 31 to 34, as dependent on claim 30, wherein the predetermined open threshold and closed threshold correspond to the pressure in the isolated volume acting on the first barrier.

36. The container adapter according to claim 35, as dependent on claim 3, wherein the predetermined open threshold and closed threshold correspond to the pressure in the isolation volume acting on the second container-facing surface of the first barrier.

37. The container adapter according to claim 30 or any one of claims 31 to 36, if dependent on claim 30, wherein the predetermined opening threshold is determined based on at least the degree of openness of the first barrier.

38. The container adapter according to claim 31 or any one of claims 32 to 37, if dependent on claim 31, wherein the predetermined closure threshold is determined based on at least the degree of the tendency of the first barrier to close.

39. The predetermined release threshold is, The dimensions and / or shape of the aforementioned isolated volume section, The characteristics of the first barrier body include at least one of the following: the toughness of the main body material, the distribution of the main body material along at least the surface located on a plane transverse to an axis parallel to the direction of the fluid flow, and the orientation of the body with respect to the direction of the fluid flow. A container adapter according to claim 37, as dependent on claim 3, determined based on one or more of the following: the peripheral wall surrounding the first barrier and the contact area formed between the corresponding wall of the adapter.

40. The predetermined closing threshold is, The dimensions and / or shape of the aforementioned isolated volume section, The characteristics of the first barrier body include at least one of the following: the elasticity of the main body material, the distribution of the main body material along at least a surface located on a plane transverse to an axis parallel to the direction of the fluid flow, and the orientation of the body with respect to the direction of the fluid flow. A container adapter according to claim 38, as dependent on claim 3, determined based on at least one of the following: the peripheral wall surrounding the first barrier and the contact area formed between the corresponding wall of the adapter.

41. The container adapter according to claim 39 or 40, wherein the contact formed in the contact area is at least partially sealed.

42. The container adapter according to any one of claims 1 to 41, wherein the first barrier has an opening configured to open when the displacement is from the closed state to the open state and to re-close when the transition is from the closed state to the open state.

43. The container adapter according to claim 42, as dependent on claim 3, wherein the opening is formed at least partially along the central portion of the first barrier body.

44. The container adapter according to claim 42 or 43, as dependent on claim 3, wherein the first barrier body is arranged such that its dimensions increase along an axis parallel to the direction of the fluid flow, and as a result the increase in material begins at the opening and gradually increases laterally toward the surrounding wall.

45. The first barrier is, A container adapter according to any one of claims 42 to 44, comprising a valve including a chamber that at least partially defines the isolated volume portion and the opening.

46. The container adapter according to claim 45, wherein the valve includes one of the following: a duckbill-shaped valve, a dome-shaped valve, and a disc-shaped valve.

47. The container adapter according to claim 45 or 46, as dependent on claim 3, wherein the valve is formed with at least one projection extending laterally from the peripheral wall toward the corresponding adapter wall.

48. The container adapter according to any one of claims 45 to 47, as dependent on claim 3, wherein the chamber extends from the second container-facing surface and terminates in close proximity to the second barrier.

49. The container adapter according to claim 48, as dependent on claim 11, wherein the chamber extends from the second container-facing surface and terminates near the distal surface of the partition wall.

50. The container adapter according to claim 48, as dependent on claim 11, wherein the chamber extends from the second container-facing surface and terminates near or adjacent to the proximal surface of the partition wall.

51. The container adapter according to claim 11 or any one of claims 12 to 44 as a result of claim 11, wherein the partition wall at least partially constitutes the first barrier, and the isolation volume portion is at least partially defined within a slit formed within the partition wall at least on the distal surface of the partition wall.

52. The container adapter according to claim 51, wherein the slit terminates within the partition body between the proximal and distal surfaces of the partition, and the partition body is formed of a permeable material configured to receive a portion of the second container.

53. The container adapter according to claim 51, wherein the slit extends from the distal surface of the partition wall to the proximal surface of the partition wall.

54. The container adapter according to any one of claims 1 to 44, wherein the first barrier comprises a bidirectional valve that is selectively displaceable between a closed state and an open state, which is operable to allow the flow of fluid through thereto from the first container to the second container in the said and opposite directions.

55. The container adapter according to claim 3 or any one of claims 4 to 54 as a dependency of claim 3, wherein the second container-facing surface and the first container-facing surface are parallel to each other and further parallel to a plane that crosses an axis parallel to the direction of the fluid flow.

56. The container adapter according to claim 55, as dependent on claim 42, wherein the distance along the parallel axis between the second container-facing surface and the first container-facing surface recedes near the opening.

57. The container adapter according to any one of claims 1 to 56, wherein at least a portion of the isolation volume is predetermined within the container adapter before the second container engages with the container adapter.

58. The container adapter according to any one of claims 1 to 57, wherein the container adapter is a vial adapter configured to be connected to a vial.

59. A method for transferring fluid between a first container and a second container associated with a fluid transfer conduit formed with a fluid port, wherein the method is: To provide a container adapter connectable to the first container, the container adapter comprising: a fluid passage configured to facilitate the transfer of the fluid between the first container and the second container; a first barrier at least partially positioned within the fluid passage; and an isolation volume extending from the first barrier toward the second container, configured to communicate with the second container, and at least partially isolated from the first container during the transfer of the fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent the flow of fluid through it and an open state operable to allow the flow of fluid through it at least in a direction extending from the second container toward the first container, Positioning the fluid port within the isolated volume section, A method comprising discharging the fluid from the fluid port into the isolated volume section, thereby displacing the first barrier to its open state.

60. The container adapter constitutes a first container adapter that can be connected to the first container, The fluid port is removed from the isolated volume section of the first container adapter, The fluid port is positioned within the isolated volume section of a subsequent container adapter that can be connected to a subsequent first container, The method according to claim 59, further comprising discharging the fluid from the fluid port into the subsequent isolated volume section.

61. The method according to claim 59 or 60, further comprising maintaining the fluid port entirely within the isolated volume during the fluid discharge from the fluid port into the isolated volume.

62. The method according to any one of claims 59 to 61, further comprising drawing the fluid from the first container into the second container through the first barrier.

63. The method according to claim 62, wherein the suction includes penetrating the fluid transfer conduit at least through the first barrier.

64. The method according to any one of claims 59 to 63, wherein providing the container adapter includes providing the container adapter according to any one of claims 1 to 58.

65. A robotic system operable for transferring fluid between a first container and a second container having a fluid transfer conduit formed with a fluid port, wherein the first container is connectable to a container adapter, the container adapter comprising: a fluid passage configured to facilitate the transfer of the fluid between the first container and the second container; a first barrier at least partially positioned within the fluid passage; and an isolation volume extending from the first barrier toward the second container, configured to be in fluid communication with the second container, and at least partially isolated from the first container during the transfer of the fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent the flow of fluid through it and an open state operable to allow the flow of fluid through it at least in a direction extending from the second container toward the first container. The aforementioned system, Controller and The system includes a manipulator that is controllable by the controller and configured to operate at least the second container, A robotic system in which the controller is configured to operate the manipulator to position the fluid port in the isolated volume section at a predetermined distance from at least the first barrier, and to maintain the fluid transfer conduit isolated from the first container during fluid transfer from at least the second container to the first container.

66. The container adapter constitutes a first container adapter that can be connected to the first container, The aforementioned manipulator, Remove the fluid port from the isolated volume section of the first container adapter, The fluid port is positioned within the isolated volume section of a subsequent container adapter that can be connected to a subsequent first container. The robot system according to claim 65, further comprising the controller configured to operate to discharge the fluid from the fluid port into the subsequent isolated volume section.

67. The robotic system according to claim 65 or 66, further comprising the controller being configured to operate the manipulator to maintain the fluid port entirely within the isolated volume during the fluid discharge from the fluid port into the isolated volume.

68. The robotic system according to any one of claims 65 to 67, further comprising the controller being configured to operate the manipulator to cause the fluid to be drawn from the first container into the second container through the first barrier.

69. The robotic system according to claim 68, wherein the suction includes penetrating the fluid transfer conduit at least through the first barrier.

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