WO2025017555A1

WO2025017555A1 - Container adaptor in a fluid transfer system

Info

Publication number: WO2025017555A1
Application number: PCT/IL2024/050701
Authority: WO
Inventors: Raanan TAVOR; Eric SHEM-TOV
Original assignee: Equashield Medical Ltd
Current assignee: Equashield Medical Ltd
Priority date: 2023-07-17
Filing date: 2024-07-17
Publication date: 2025-01-23
Anticipated expiration: 2026-01-17

Abstract

A container adaptor connectable to a first container of a fluid transfer system for transfer of fluid between the first container and a second container of the fluid transfer system. The container adaptor includes a fluid flow path configured to facilitate the transfer of fluid between the first container and the second container. The container adaptor includes a first barrier positioned at least partially within the fluid flow path, a second barrier positioned at least partially within the fluid flow path, and an isolated volume defined at least partially between the first barrier and at least a portion of the second barrier and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during the transfer of fluid.

Description

CONTAINER ADAPTOR IN A FLUID TRANSFER SYSTEM

TECHNICAL FIELD

The presently disclosed subject matter relates to the field of fluid transfer devices, and more particularly to an adaptor for connecting to a container of a fluid transfer system and facilitating fluid transfer.

BACKGROUND

Adaptors are generally connected to a container to facilitate transfer of fluid between a first container and a second container. For instance, in a fluid transfer system such as of a pharmaceutical preparation system, a first container contains a volume of fluid that is to be received from the second container, and an adaptor is connected to the first container for facilitating the transfer of fluid. Precautions must be taken to reduce or avoid altogether the occurrence of cross-contamination and microbial ingress caused by solid, liquid, droplets or gas residues from a substance contained in the first container and accumulating on a portion of the second container.

For example, during dilution of a solid or liquid substance in a vial, a needle of a syringe is inserted into the vial for discharging a dilutant into the vial. Exposure of the needle to the vial contents can cause accumulation of the substance residues on its tip. Cautionary measures are taken to prevent cross-contamination and microbial ingress caused by introducing the accumulated residues on the tip into a subsequent vial. Such measures can include discarding the syringe after a single use and provision of a new syringe for diluting the subsequent vial.

GENERAL DESCRIPTION

There is provided a device, system and method for transfer of fluid between a first container and a second container while facilitating repeated use of the second container when transferring the fluid in between the second container and multiple first containers in a pharmaceutical preparation system.

More particularly, in the field of medical drug transfers, drugs and/or dilutants are contained in vials and/or IV bags and need to be transferred into different containers, for example by containers such as syringes and/or other IV bags, for mixing with other drugs in liquid, or solid form, with diluting liquids and/or delivery to a patient. It is generally practiced in some cases, for example in environments dealing with hazardous drugs or with non- hazardous drugs, to connect the syringe and/or the IV bag to the vial and/or the other IV bag via an adaptor.

In some embodiments, the fluid transfer system comprises a robotic system which is configured to handle and operate the containers to perform the transfer of fluid. For instance, the robotic system is described as having a manipulator configured to manipulate the containers. Also, although in all of the examples described herein, the manipulator is described as a robotic arm, it is to be understood that the manipulator can be a platform, a robotic station, or the like having holders to hold the fluid transfer apparatus components and move them relatively to each other and facilitate the performance of the transfer of fluid.

The following terms and their derivatives used throughout the application may be better understood in view of the explanations below:

The pharmaceutical preparation system may comprise any one or more of a dilution station, namely a reconstitution station where any type of a dilutant is added to a drug which is in solid and/or liquid form. The pharmaceutical preparation system may comprise any one or more of a filling station, namely a compounding station where an at least partially or fully prepared drug is transferred into a container by aspiration of the drug from a first container and injecting it into a further container.

The terms “pharmaceutical” and “drug” are used interchangeably.

A fluid transfer conduit may comprise any means for transferring a fluid, or example a needle or tube. A needle may comprise a cannula or any other device configured for penetrating a container and transferring fluid therethrough. The needle may include a bevel at a distal tip thereof or an opening at a side surface or any other configuration.

A septum may generally refer to a membrane configured to close access to a part of a device to which it belongs. Generally, a septum on a container or container connector may seal the container. A septum on a container may prevent or resist access to a fluid transfer conduit. Typically, a septum is made of a resilient pierceable material. Such material may be a polymer with elastic properties like rubber or any other suitable material. A robotic system may comprise an automatic or partially automatic system comprising a manipulator controlled, at least partially by a controller unit (also referred to as controller or control unit).

A manipulator may comprise a robotic arm, a platform, a robotic station, or a combination thereof configured for manipulating the container and/or the fluid transfer assembly.

A controller or a controller unit may comprise a computer controller configured to perform operations in accordance with a set of instructions stored on a 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 includes one or more control circuits. In some examples, the control unit can include one or more mechanism controllers. The controller unit may comprise any means to control elements in a robotic pharmaceutical preparation system and may comprise at least any one of a controller, a synchronizing unit and a processer.

The robotic pharmaceutical preparation system comprises the robotic system operable for performing any activity related to preparation of drugs designated for administration to patients. It is noted that the term “robotic systems” used herein may include robotic pharmaceutical preparation systems.

The terms proximal and distal are to be understood herein as being used with respect to a user. In the examples described herein the first container is positioned more distally from the user than the second container, though it is appreciated that the order is interchangeable.

A longitudinal axis LI extends centrally along a length of the container adaptor.

A lateral axis L2 is orthogonal to longitudinal axis LI and extends to the breadth of the container adaptor towards it sides.

A central plane P includes the lateral axis L2 and transverses the longitudinal axis LI

A lateral orientation in a body (e.g. the first barrier body 142 in Fig. 3) refers to an orientation extending from the middle of the body outwards to the sides of the body.

A medial orientation in a body refers to an orientation extending from the sides of the body toward its middle. The container adaptor may be configured to be deployed for preparation of any type of drug, including a hazardous drug which is prepared in closed systems, as well as non-hazardous drugs. Additionally, the pharmaceutical preparation system may be deployed for preparation of any type of drug, including a hazardous drug which is prepared in closed systems, as well as non-hazardous drugs.

There is thus provided in accordance with an embodiment of the present application a container adaptor connectable to a first container of a fluid transfer system for transfer of fluid between the first container and a second container of the fluid transfer system.

The first and second containers described herein may comprise any container being a component of a fluid transfer apparatus with or without an adaptor or connector for establishing fluid communication of the first container with the second container. It is to be understood that the first container and second container can comprise any container configured for receiving a fluid (gas or liquid or a combination thereof) therein. For example, the first or second containers are described herein with reference to a vial and/or a syringe yet may comprise an intravenous bag (IV bag) a fluid transfer pipe, conduit, etc.. Furthermore, the first or second containers may comprise a fluid transfer assembly, such as the syringe, or a syringe assembly which includes syringe and a syringe connector. In some embodiments, the fluid transfer assembly can include a pumping mechanism and a fluid transfer pipe configured to be connected to the first or second container for the transfer of drug. In some examples, the fluid transfer assembly can include a fluid transfer connector (or adaptor) for establishing fluid communication between a fluid transfer unit (a fluid transfer pipe, conduit, pump, syringe, etc.) and the the first or second container.

Further, in the examples described herein, the transfer of fluid is described being performed by the fluid transfer conduit. The fluid transfer conduit may comprise a needle penetrating the container septum while ingressing the first or second container. It is to be understood herein that in some examples the transfer of fluid can be performed without the needle penetrating through the container septum, or optionally not penetrating even through a septum of the fluid transfer connector (associated with the fluid transfer assembly). In some examples, the fluid transfer can be performed even without a needle and via the fluid transfer conduit by controlled pressure of the fluid. The container adaptor comprises a fluid flow path configured to facilitate the transfer of fluid between the first container and the second container. The container adaptor comprises a first barrier positioned at least partially within the fluid flow path, a second barrier positioned at least partially within the fluid flow path, and an isolated volume defined at least partially between the first barrier and at least a portion of the second barrier and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during the transfer of fluid.

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

The isolated volume is configured to fluidically isolate its volume and prevent any fluid exchange via the first barrier during the closed state, such as for example when the container adaptor is connected to the first or second container.

The isolated volume may be dimensioned to any size. For example, the isolated volume may comprise a portion of the interior portion 140 of the container adaptor 120, such as shown in Figs. 5 A and 6, or may be defined within a septum 152, such as shown in Figs. 7 and 9. In some embodiments, the isolated volume may be defined by a relatively small volume such as a volume which contains the fluid discharged by the fluid transfer conduit.

The first barrier may be configured to separate between the isolated volume and an exposed volume which is fluidically exposed to the fluid contained within the first or second container.

In some embodiments, the isolated volume may be dimensioned to any suitable size for receiving the fluid therein.

There is thus provided in accordance with an embodiment of the present application, a container adaptor connectable to a first container of a fluid transfer system for transfer of fluid between the first container and a second container of the fluid transfer system, the adaptor including a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path, a second barrier positioned at least partially within the fluid flow path, and an isolated volume defined at least partially between the first barrier and at least a portion of the second barrier and being configured to be in fluid communication with the second container and being isolated from the first container during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container during the transfer of fluid.

In some embodiments, the container adaptor includes a proximal end portion, a distal end portion extending, at least partially along a longitudinal axis of the adaptor, distally from the proximal end portion towards the first container, when connected to the container adaptor, and an interior 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 at least partially within the interior portion.

In some embodiments, the first barrier has a first barrier body comprising a first container-facing surface configured to face, at least partially, towards the first container when connected to the container adaptor, 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 second container-facing surface.

In some embodiments, the first barrier is positioned in the fluid flow path intermediate the proximal end portion and the distal end portion. In some embodiments, the first barrier is positioned in the fluid flow path at a greater proximity to the proximal end portion than the distal end portion.

In some embodiments, the first barrier is positioned in the fluid flow path at a greater proximity to the distal end portion than the proximal end portion. In some embodiments, the first barrier is configured with a first barrier mounting element, mountable to a corresponding adaptor mounting element of the interior portion. In some embodiments, the first barrier mounting element includes a flange mountable on the corresponding adaptor mounting element, which is formed with a recess configured to receive the flange. In some embodiments, the first barrier peripheral wall is configured to be mountable to a corresponding adaptor wall of the container adaptor. In some embodiments, the corresponding adaptor wall of the container adaptor constitutes a wall of the interior portion.

In some embodiments, the second barrier constitutes at least a portion of a septum, the septum having a septum body comprising a septum proximal surface, a septum distal surface extending distally from the septum proximal surface along a longitudinal axis of the adaptor, and a septum peripheral wall extending between the septum proximal surface and the septum distal surface.

In some embodiments, the septum is disposed at least partially within the proximal end portion. In some embodiments, the first barrier is disposed distally along the longitudinal axis from the septum proximal surface. In some embodiments, the septum distal surface constitutes at least partially the second barrier. In some embodiments, the septum proximal surface constitutes at least partially the second barrier. In some embodiments, the septum distal surface constitutes at least partially the first barrier and the isolated volume extends at least partially between the septum proximal surface and the septum distal surface. In some embodiments, the first barrier is disposed at least partially within the septum body.

In some embodiments, the septum is configured to be at least partially pierceable by a fluid transfer conduit associated with the second container. In some embodiments, the septum is configured to be repeatedly pierceable by the fluid transfer conduit at least upon insertion of the fluid transfer conduit into the second barrier and removal therefrom.

In some embodiments, the isolated volume is configured to receive therein at least a portion of a fluid transfer conduit associated with the second container. In some embodiments, the isolated volume is configured to receive a fluid discharged by a fluid transfer conduit associated with the second container and retain the fluid therein during the closed state of the first barrier. In some embodiments, the first barrier is configured to allow needleless flow of the fluid therethrough into the first container during the opened state of the first barrier. In some embodiments, the first barrier includes a pierceable material for allowing a fluid transfer conduit associated with the second container to at least partially pierce the first barrier so as to facilitate aspiration of fluid from the first container towards the second container.

In some embodiments, the first barrier is configured to divide the fluid flow path into the isolated volume and an exposed volume, which extends distally from the first barrier and is configured to be exposed to the first container and be in fluid communication therewith when the first container is connected to the container adaptor.

In some embodiments, at least a portion of the exposed volume extends within the container adaptor distally from the first barrier. In some embodiments, at the opened state, the first barrier allows fluid to flow at least from the isolated volume to the exposed volume. In some embodiments, at the closed state, the first barrier prevents fluid flow between the isolated volume to the exposed volume. In some embodiments, the first barrier is configured to displace from the closed state to the opened state in response to a pressure differential applied across the first barrier.

In some embodiments, the pressure differential is applied across the first barrier in the direction of the fluid flow during transfer thereof. In some embodiments, the first barrier is configured to displace from the closed state to the opened state upon an increase of pressure in the isolated volume beyond a predetermined opening pressure threshold. In some embodiments, the first barrier is configured to displace from the opened state to the closed state upon a decrease of pressure in the isolated volume to below a predetermined closing threshold. In some embodiments, the predetermined opening threshold and the predetermined closing threshold are the same. In some embodiments, the predetermined opening threshold and the predetermined closing threshold are different. In some embodiments, the predetermined opening threshold is greater than the predetermined closing threshold. In some embodiments, the predetermined opening and closing thresholds correspond to a pressure within the isolated volume exerted on the first barrier. In some embodiments, the predetermined opening and closing thresholds correspond to a pressure within the isolated volume exerted on the second container-facing surface of the first barrier.

In some embodiments, the predetermined opening threshold is determined based on at least a degree of openability of the first barrier. Additionally or alternatively, the predetermined closing threshold is determined based on at least a degree of a propensity of the first barrier to close.

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

Additionally or alternatively, the predetermined closing threshold is determined based on at least one or more of the dimensions and/or shape of the isolating volume, the properties of the first barrier body including at least one of the body material resilience, a distribution of the body material at least along a surface lying on a plane transversing 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, and a contact area formed between the first barrier peripheral wall and a corresponding wall of the adaptor.

In some embodiments, a contact formed at said contact area is at least partially a sealed contact. In some embodiments, the first barrier includes an opening configured to open upon said displacement from the closed state to the opened state and to reclose upon transitioning from the closed state to the opened state. In some embodiments, the opening is formed at least partially along a central portion of the first barrier body.

In some embodiments, the first barrier body is arranged to increase in its dimension lying on an axis parallel to the direction of the fluid flow, whereupon the material increase commences from the opening and gradually increases laterally towards the peripheral wall.

In some embodiments, the first barrier includes a valve including: a chamber at least partially defining the isolated volume, and the opening. In some embodiments, the valve includes any one of a duckbill-like shaped valve, a dome-like shaped valve, and a disk-like shaped valve. In some embodiments, the valve is formed with at least one projection extending laterally from the peripheral wall towards a corresponding adaptor wall. In some embodiments, the chamber extends from the second containerfacing surface and terminates at the second barrier or in proximity thereto. In some embodiments, the chamber extends from the second container-facing surface and terminates at the septum distal surface or in proximity thereto. Additionally or alternatively, the chamber extends from the second container-facing surface and terminates at the septum proximal surface or in proximity thereto.

In some embodiments, the septum at least partially constitutes the first barrier and the isolated volume is defined at least partially within a slit formed in the septum at least at the septum distal surface. In some embodiments, the slit terminates within the septum body in between the septum proximal surface and the septum distal surface and the septum body is formed of a pierceable material configured for receiving a portion of the second container. In some embodiments, the slit extends from the septum distal surface through to the septum proximal surface. Additionally or alternatively, the first barrier includes a bidirectional valve selectively displaceable between said closed state and said opened state operable to allow fluid flow therethrough in said direction extending from the first container to the second container and in the opposite direction, during said transfer of fluid.

In some embodiments, the second container-facing surface and the first containerfacing surface are parallel thereto and further to a plane transversing an axis parallel to the direction of the fluid flow.

In some embodiments, a distance along said parallel axis between the second container-facing surface and the first container-facing surface recedes in the vicinity of the opening. In some embodiments, at least a portion of the isolated volume is predefined in the container adaptor at least prior to engagement of the second container with the container adaptor. In some embodiments, the container adaptor is a vial adaptor configure to be connected to a vial.

There is thus provided in accordance with an embodiment of the present application, a method for transfer of a fluid in 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 adaptor connectable to the first container, said container adaptor comprising: a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path and an isolated volume extending from the first barrier towards the second container and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container, positioning the fluid port within the isolated volume, an discharging of the fluid from the fluid port into the isolated volume, thereby causing the first barrier to displace into its opened state.

In some embodiments, the container adaptor constitutes an initial container adaptor connectable to an initial first container, and further comprising removal of the fluid port from the isolated volume of the initial container adaptor, positioning the fluid port within an isolated volume of a subsequent container adaptor connectable to a subsequent first container, and discharging the fluid from the fluid port into the subsequent isolated volume. In some embodiments, the method further comprises maintaining the fluid port positioned within the isolated volume all during the fluid discharge therefrom into the isolated volume. In some embodiments, the method further comprises aspirating the fluid from the first container into the second container via the first barrier. In some embodiments, aspirating includes piercing the fluid transfer conduit at least through the first barrier. In some embodiments, the method is performed with the container adaptor according to any one of the embodiments described herein.

There is thus provided in accordance with an embodiment of the present application, a robotic system operable for transfer of a fluid in between a first container and a second container comprising a fluid transfer conduit formed with a fluid port, the first container connectable to a container adaptor comprising a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path and an isolated volume extending from the first barrier towards the second container and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container, the system comprising a controller, and a manipulator controllable by the controller and configured to manipulate at least the second container, the controller being configured to operate the manipulator to position the fluid port within the isolated volume at a predetermined distance from at least the first barrier and maintain the fluid transfer conduit isolated from the first container at least during fluid transfer from the second container to the first container.

In some embodiments, the container adaptor constitutes an initial container adaptor connectable to an initial first container, and further comprising the controller being configured to operate the manipulator to remove the fluid port from the isolated volume of the initial container adaptor, position the fluid port within an isolated volume of a subsequent container adaptor connectable to a subsequent first container, and cause the discharge the fluid from the fluid port into the subsequent isolated volume.

In some embodiments, the robotic system further comprises the controller being configured to operate the manipulator to maintain the fluid port positioned within the isolated volume all during the fluid discharge therefrom into the isolated volume. In some embodiments, the controller is configured to operate the manipulator to cause the aspiration of the fluid from the first container into the second container via the first barrier. In some embodiments, aspirating includes piercing the fluid transfer conduit at least through the first barrier.

EMBODIMENTS

A more specific description is provided in the Detailed Description whilst the following are non-limiting examples of different embodiments of the presently disclosed subject matter.

1. A container adaptor connectable to a first container of a fluid transfer system for transfer of fluid between the first container and a second container of the fluid transfer system, the adaptor comprising: a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container; a first barrier positioned at least partially within the fluid flow path; a second barrier positioned at least partially within the fluid flow path; and an isolated volume defined at least partially between the first barrier and at least a portion of the second barrier and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during said transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container during said transfer of fluid.

2. The container adaptor according to embodiment 1, wherein the container adaptor comprises: a proximal end portion; a distal end portion extending, at least partially along a longitudinal axis of the adaptor, distally from the proximal end portion towards the first container, when connected to the container adaptor; and an interior 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 at least partially within the interior portion.

3. The container adaptor according to embodiment 1 or 2, wherein the first barrier has a first barrier body comprising: a first container-facing surface configured to face, at least partially, towards the first container when connected to the container adaptor; 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 second container-facing surface.

4. The container adaptor according to embodiment 2 or embodiment 3, when dependent on embodiment 2, wherein the first barrier is positioned in the fluid flow path intermediate the proximal end portion and the distal end portion.

5. The container adaptor according to embodiment 4, wherein the first barrier is positioned in the fluid flow path at a greater proximity to the proximal end portion than the distal end portion.

6. The container adaptor according to embodiment 4, wherein the first barrier is positioned in the fluid flow path at a greater proximity to the distal end portion than the proximal end portion.

7. The container adaptor according to embodiment 2 or any one of embodiments 3-6, when dependent on embodiment 2, wherein the first barrier is configured with a first barrier mounting element, mountable to a corresponding adaptor mounting element of the interior portion.

8. The container adaptor according to embodiment 7, wherein the first barrier mounting element comprises a flange mountable on the corresponding adaptor mounting element, which is formed with a recess configured to receive the flange. 9. The container adaptor according to embodiment 3 or any one of embodiments 4-8 when dependent on embodiment 3, wherein the first barrier peripheral wall is configured to be mountable to a corresponding adaptor wall of the container adaptor.

10. The container adaptor according to embodiment 9, when dependent on embodiment 2, wherein the corresponding adaptor wall of the container adaptor constitutes a wall of the interior portion.

11. The container adaptor according to any one of embodiments 1-10, wherein the second barrier constitutes at least a portion of a septum, the septum having a septum body comprising: a septum proximal surface; a septum distal surface extending distally from the septum proximal surface along a longitudinal axis of the adaptor; and a septum peripheral wall extending between the septum proximal surface and the septum distal surface.

12. The container adaptor according to embodiment 11, when dependent on embodiment 2, wherein the septum is disposed at least partially within the proximal end portion.

13. The container adaptor according to embodiment 11 or 12, wherein the first barrier is disposed distally along the longitudinal axis from the septum proximal surface.

14. The container adaptor according to any one of embodiments 11-13, wherein the septum distal surface constitutes at least partially the second barrier.

15. The container adaptor according to any one of embodiments 11- 13, wherein the septum proximal surface constitutes at least partially the second barrier. The container according to embodiment 15, wherein the septum distal surface constitutes at least partially the first barrier and the isolated volume extends at least partially between the septum proximal surface and the septum distal surface. The container adaptor according to any one of embodiments 11-16, wherein the first barrier is disposed at least partially within the septum body. The container adaptor according to any one of embodiments 11-17, wherein the septum is configured to be at least partially pierceable by a fluid transfer conduit associated with the second container. The container adaptor according to embodiment 18, wherein the septum is configured to be repeatedly pierceable by the fluid transfer conduit at least upon insertion of the fluid transfer conduit into the second barrier and removal therefrom. The container adaptor according to any one of embodiments 1-19, wherein the isolated volume is configured to receive therein at least a portion of a fluid transfer conduit associated with the second container. The container adaptor according to any one of embodiments 1-20, wherein the isolated volume is configured to receive a fluid discharged by a fluid transfer conduit associated with the second container and retain the fluid therein during the closed state of the first barrier. The container adaptor according to any one of embodiments 1-21, wherein the first barrier is configured to allow needleless flow of the fluid therethrough into the first container during the opened state of the first barrier. The container adaptor according to any one of embodiments 1-22, wherein the first barrier comprises a pierceable material for allowing a fluid transfer conduit associated with the second container to at least partially pierce the first barrier so as to facilitate aspiration of fluid from the first container towards the second container. The container adaptor according to any one of embodiments 1-23, wherein the first barrier is configured to divide the fluid flow path into the isolated volume and an exposed volume, which extends distally from the first barrier and is configured to be exposed to the first container and be in fluid communication therewith when the first container is connected to the container adaptor. The container adaptor according to embodiment 24, wherein at least a portion of the exposed volume extends within the container adaptor distally from the first barrier. The container adaptor according to embodiment 24 or 25, wherein at the opened state, the first barrier allows fluid to flow at least from the isolated volume to the exposed volume. The container adaptor according to any one of embodiments 24-26, wherein at the closed state, the first barrier prevents fluid flow between the isolated volume to the exposed volume. The container adaptor according to any one of embodiments 1-27, wherein the first barrier is configured to displace from the closed state to the opened state in response to a pressure differential applied across the first barrier. The container adaptor according to embodiment 28, wherein the pressure differential is applied across the first barrier in the direction of the fluid flow during transfer thereof. The container adaptor according to claim 24 or any one of claims 25-29 when dependent on claim 24, wherein the first barrier is configured to displace from the closed state to the opened state upon an increase of differential pressure between the isolated volume and exposed volume beyond a predetermined opening pressure threshold. The container adaptor according to claim 24 or any one of claims 25-30, wherein the first barrier is configured to displace from the opened state to the closed state upon a decrease of differential pressure between the isolated volume and exposed volume to below a predetermined closing threshold. The container adaptor according to embodiment 31, when dependent on embodiment 30, wherein the predetermined opening threshold and the predetermined closing threshold are the same. The container adaptor according to embodiment 31, when dependent on embodiment 30, wherein the predetermined opening threshold and the predetermined closing threshold are different. The container adaptor according to embodiment 33, wherein the predetermined opening threshold is greater than the predetermined closing threshold. The container adaptor according to any one of embodiments 31-34, when dependent on embodiment 30, wherein the predetermined opening and closing thresholds correspond to a pressure within the isolated volume exerted on the first barrier. The container adaptor according to embodiment 35, when dependent on embodiment 3, wherein the predetermined opening and closing thresholds correspond to a pressure within the isolated volume exerted on the second container-facing surface of the first barrier. The container adaptor according to embodiment 30 or any one of embodiments

31-36 when dependent on embodiment 30, wherein the predetermined opening threshold is determined based on at least a degree of openability of the first barrier. The container adaptor according to embodiment 31 or any one of embodiments

32-37 when dependent on embodiment 31, wherein the predetermined closing threshold is determined based on at least a degree of a propensity of the first barrier to close.

39. The container adaptor according to embodiment 37, when dependent on embodiment 3, wherein the predetermined opening threshold is determined based on one or more of: the dimensions and/or shape of the isolating volume; the properties of the first barrier body including at least one of: a body material toughness, a distribution of the body material at least along a surface lying on a plane transversing an axis parallel to the direction of the fluid flow and an orientation of the body with respect to the direction of the fluid flow; and a contact area formed between the first barrier peripheral wall and a corresponding wall of the adaptor.

40. The container adaptor according to embodiment 38, when dependent on embodiment 3, wherein the predetermined closing threshold is determined based on at least one or more of: the dimensions and/or shape of the isolating volume; the properties of the first barrier body including at least one of: the body material resilience, a distribution of the body material at least along a surface lying on a plane transversing 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; and a contact area formed between the first barrier peripheral wall and a corresponding wall of the adaptor.

41. The container adaptor according to embodiment 39 or 40, wherein a contact formed at said contact area is at least partially a sealed contact.

42. The container adaptor according to any one of embodiments 1-41, wherein the first barrier comprises an opening configured to open upon said displacement from the closed state to the opened state and to reclose upon transitioning from the closed state to the opened state. 43. The container adaptor according to embodiment 42, when dependent on embodiment 3, wherein the opening is formed at least partially along a central portion of the first barrier body.

44. The container adaptor according to embodiment 42 or 43, when dependent on embodiment 3, wherein the first barrier body is arranged to increase in its dimension lying on an axis parallel to the direction of the fluid flow, whereupon the material increase commences from the opening and gradually increases laterally towards the peripheral wall.

45. The container adaptor according to any one of embodiments 42-44, wherein the first barrier comprises a valve including: a chamber at least partially defining the isolated volume; and the opening.

46. The container adaptor according to embodiment 45, wherein the valve comprises any one of a duckbill-like shaped valve, a dome-like shaped valve, and a disk-like shaped valve.

47. The container adaptor according to embodiment 45 or 46, when dependent on embodiment 3, wherein the valve is formed with at least one projection extending laterally from the peripheral wall towards a corresponding adaptor wall.

48. The container adaptor according any one of embodiments 45-47, when dependent on embodiment 3, wherein the chamber extends from the second container-facing surface and terminates at the second barrier or in proximity thereto.

49. The container adaptor according to embodiment 48, when dependent on embodiment 11, wherein the chamber extends from the second container-facing surface and terminates at the septum distal surface or in proximity thereto. The container adaptor according to embodiment 48, when dependent on embodiment 11, wherein the chamber extends from the second container-facing surface and terminates at the septum proximal surface or in proximity thereto. The container adaptor according to embodiment 11 or any one of embodiments 12-44 when dependent on embodiment 11, wherein the septum at least partially constitutes the first barrier and the isolated volume is defined at least partially within a slit formed in the septum at least at the septum distal surface. The container adaptor according to embodiment 51, wherein the slit terminates within the septum body in between the septum proximal surface and the septum distal surface and the septum body is formed of a pierceable material configured for receiving a portion of the second container. The container adaptor according to embodiment 51, wherein the slit extends from the septum distal surface through to the septum proximal surface. The container adaptor according to any one of embodiments 1-44, wherein the first barrier comprises a bidirectional valve selectively displaceable between said closed state and said opened state operable to allow fluid flow therethrough in said direction extending from the first container to the second container and in the opposite direction, during said transfer of fluid. The container adaptor according to embodiment 3 or any one of embodiments 4-54 when dependent on embodiment 3, wherein the second container-facing surface and the first container-facing surface are parallel thereto and further to a plane transversing an axis parallel to the direction of the fluid flow. The container adaptor according to embodiment 55 when dependent on embodiment 42, wherein a distance along said parallel axis between the second container-facing surface and the first container-facing surface recedes in the vicinity of the opening. 57. The container adaptor according to any one of embodiments 1-56, wherein at least a portion of the isolated volume is predefined in the container adaptor at least prior to engagement of the second container with the container adaptor.

58. The container adaptor according to any one of embodiments 1-57, wherein the container adaptor is a vial adaptor configure to be connected to a vial.

59. A method for transfer of a fluid in 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 adaptor connectable to the first container, said container adaptor comprising: a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path and an isolated volume extending from the first barrier towards the second container and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container; positioning the fluid port within the isolated volume; and discharging of the fluid from the fluid port into the isolated volume, thereby causing the first barrier to displace into its opened state.

60. The method according to embodiment 59, wherein the container adaptor constitutes an initial container adaptor connectable to an initial first container, and further comprising: removal of the fluid port from the isolated volume of the initial container adaptor; positioning the fluid port within an isolated volume of a subsequent container adaptor connectable to a subsequent first container; and discharging the fluid from the fluid port into the subsequent isolated volume. 61. The method according to embodiment 59 or 60, further comprising maintaining the fluid port positioned within the isolated volume all during the fluid discharge therefrom into the isolated volume.

62. The method according to any one of embodiments 59-61, further comprising aspirating the fluid from the first container into the second container via the first barrier.

63. The method according to embodiment 62, wherein the aspirating comprises piercing the fluid transfer conduit at least through the first barrier.

64. The method according to any one of embodiments 59-63, wherein providing the container adaptor includes providing the container adaptor according to any one of embodiments 1 to 58.

65. A robotic system operable for transfer of a fluid in between a first container and a second container comprising a fluid transfer conduit formed with a fluid port, the first container connectable to a container adaptor comprising a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path and an isolated volume extending from the first barrier towards the second container and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during the transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container, the system comprising: a controller; and a manipulator controllable by the controller and configured to manipulate at least the second container, the controller being configured to operate the manipulator to position the fluid port within the isolated volume at a predetermined distance from at least the first barrier and maintain the fluid transfer conduit isolated from the first container at least during fluid transfer from the second container to the first container.

66. The robotic system according to embodiment 65, wherein the container adaptor constitutes an initial container adaptor connectable to an initial first container, and further comprising the controller being configured to operate the manipulator to: remove the fluid port from the isolated volume of the initial container adaptor; position the fluid port within an isolated volume of a subsequent container adaptor connectable to a subsequent first container; and cause the discharge the fluid from the fluid port into the subsequent isolated volume.

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 positioned within the isolated volume all during the fluid discharge therefrom into the isolated volume.

68. The robotic system according to any one of embodiments 65-67, further comprising the controller being configured to operate the manipulator to cause the aspiration of the fluid from the first container into the second container via the first barrier.

69. The robotic system according to embodiment 68, wherein the aspirating comprises piercing the fluid transfer conduit at least through the first barrier.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it can be carried out in practice, embodiments will be described, by way of non-limiting examples, with reference to the accompanying drawings, in which:

Figs. 1A and IB are a block diagram illustration of a fluid transfer system within a pharmaceutical preparation system according to an embodiment of the presently disclosed application, shown in a closed state (1A) and in an opened state (IB); Fig. 2 is a schematic illustration of a fluid transfer system including a container adaptor, according to an embodiment of the presently disclosed application, shown in a closed state;

Fig. 3 is a schematic illustration of an exemplary container adaptor operatively coupled to a container, according to an embodiment of the presently disclosed application, shown in a closed state;

Fig. 4A is a block diagram illustration of a fluid transfer system of a pharmaceutical preparation system according to an embodiment of the presently disclosed application, shown in a closed state;

Fig. 4B is a block diagram illustration of a robotic fluid transfer system of a robotic pharmaceutical preparation system according to an embodiment of the presently disclosed application, shown in a closed state;

Figs. 5A and 5B are a sectional illustration of a container adaptor, shown in a closed state (5A) and a sectional illustration of a valve element of the container adaptor of Fig. 5A (5B), according to an embodiment of the presently disclosed application;

Fig. 6 is a sectional illustration of a container adaptor according to an embodiment of the presently disclosed application, shown in a closed state;

Fig. 7 is a sectional illustration of a container adaptor according to an embodiment of the presently disclosed application, shown in an opened state;

Figs. 8A-C are a sectional illustration of a container adaptor, shown in a closed state (8A), a perspective view of a valve element of the container adaptor of Fig. 8A (8B) and a sectional illustration of Fig. 8B (8C), according to an embodiment of the presently disclosed application; and

Fig. 9 is a sectional illustration of a container adaptor according to an embodiment of the presently disclosed application, shown in a closed state.

DETAILED DESCRIPTION

The following detailed description sets forth general and specific details about features of the adaptors according to various aspects and examples of the presently disclosed subject matter.

Reference is made to Figs. 1A and IB, which are block diagrams of a fluid transfer system 10. The fluid transfer system 10 comprises a first container 12 and a second container 14 mutually arranged for facilitating flow of a fluid 16 within a fluid flow path 18 in 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 ingress between the first and second containers 12 and 14, respectfully, the fluid transfer system 10 is provided with an isolated volume 20 configured to be in fluid communication with one of the first and second containers 12 and 14, respectfully, and being fluidly isolated from the other container.

The isolated volume 20 may be contained in any suitable portion, such as an isolated volume-containing portion 22 of the system 10, for example which may be disposed for example within the first container 12, the second container 14 and/ or with a container adaptor 120 (Fig. 3).

The isolated volume 20 extends from a first barrier 24, which is positioned at least partially within the fluid flow path 18. The first barrier 24 is configured to be selectively displaceable between a closed state (Fig. 1A), operable to prevent fluid flow therethrough, and an opened state (Fig. IB), operable to allow fluid flow therethrough.

In some embodiments, the fluid flows at least from the second container 14 to the first container 12 and the isolated volume 20 extends from the first barrier 24 towards the second container 14 and is isolated from the first container 12.

The first barrier 24 is configured to divide the fluid flow path into the isolated volume 20 and an exposed volume 28. The exposed volume 28 extends from the first barrier 24 and is configured to be fluidically exposed to and in fluid communication with one of the first and second containers, which is isolated from the isolated volume 20. In some embodiments, for example as illustrated herein, the exposed volume 28 extends from the first barrier 24 towards the first container 12 and is exposed to and in fluid communication with the first container 12.

As shown in Fig. 1 A, at the closed state, the first barrier 24 prevents fluid flow at least from the isolated volume 20 to the exposed volume 28, , and at the opened state, as shown in Fig. IB, the first barrier 24 allows fluid to flow from the isolated volume 20 at least to the exposed volume 28, which may comprise the first container 12 or be in fluid communication with the first container 12.

As seen in Fig. 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 release of the fluid therefrom. The fluid transfer conduit 30 is in fluid communication with the second container 14 and, in some embodiments, is materially connected to the second container 14. The first barrier 24 is selectively displaceable between the closed state, operable to prevent fluid flow therethrough, and the opened state, operable to allow fluid flow therethrough at least in a direction extending from the second container 14 to the first container 12, shown by arrow XI in Fig. IB.

Turning to Fig. 3 it is seen that in some embodiments, the first barrier 24 is positioned in a container adaptor 120 connectable to the first container 12. The container adaptor 120 comprises at least a portion of the fluid flow path 18 and the first barrier 24 is disposed in the fluid flow path 18. The container adaptor 120 may comprise at least a portion of the isolated volume 20 therein.

It is noted that in some embodiments the container adaptor 120 may be connectable to the second container 14.

It is further noted that in some embodiments the isolated volume 20 may be positioned out of the container adaptor 120, such as within the first container 12 or the second container 14.

In some embodiments, the container adaptor 120 may comprise at least a portion of the exposed volume 28 therein and at least a portion of the exposed volume 28 extends within the container adaptor 120 distally from the first barrier 24 along a longitudinal axis LI of the container adaptor 120.

It is noted that in some embodiments, the exposed volume 28 may be positioned out of the container adaptor 120, such as within the first container 12 or the second container 14.

The container adaptor 120 comprises a proximal end portion 132 and a distal end portion 134, extending distally from the proximal end portion 132 towards the first container 12 at least partially along the longitudinal axis LI.

In some embodiments, the proximal end portion 132 is closer to the user than the distal end portion 134 when the container adaptor 120 is held by the user for connection to the first container 12. In other words, the distal end portion 134 is closer to the first container 12 than the proximal end portion 132. Thus, the distal end portion 134 extending distally from the proximal end portion 132 is to be understood as extending towards the first container 12.

The container adaptor 120 is configured in any suitable shape, such as shown for example in Figs. 5A-9, in which the proximal end portion 132 comprises an elongated shaft 135 extending distally to a disk-shaped portion. In some embodiments the container adaptor 120 comprises a septum 152 which is positioned at proximal end portion 132 or at any other suitable location. The container adaptor 120 may be provided with a spike 136 extending distally from the disk-shaped portion and configured to pierce into a septum (not shown) of the first container 12 during connection of the container adaptor 120 and the first container 12. The spike 136 may comprise a liquid channel for transfer of liquid. In some embodiments, the spike 136 may further comprise an air channel for transfer of air.

The container adaptor 120 is formed with attachment means 138 for connecting to the first container 12. The attachment means 138 may be formed at the distal end portion 134 or at any other suitable location for connecting to the first container 12.

The container adaptor 120 comprises an interior portion 140 extending between the proximal end portion 132 and the distal end portion 134. The fluid flow path 18 at least partially extends within the interior portion 140 along the longitudinal axis LI.

The first barrier 24 is positioned within the fluid flow path 18 at any suitable location. In some embodiments, the first barrier 24 is positioned in the fluid flow path 18 intermediate the proximal end portion 132 and the distal end portion 134. In some embodiments, the first barrier 24 is positioned in the fluid flow path 18 at a greater proximity to the proximal end portion 132 than the distal end portion 134. In some embodiments, the first barrier 24 is positioned in the fluid flow path 18 at a greater proximity to the distal end portion 134 than the proximal end portion 132.

In some embodiments, the first barrier 24 is positioned at a distal end surface 141 of the distal end portion 134 of the container adaptor 120.

As shown in Fig. 3, the first barrier 24 may be formed in any suitable manner having a body 142 comprising a first container-facing surface 144 and a second container-facing surface 146. In some embodiments, the first container-facing surface 144 extends distally from the second container-facing surface 146 along the longitudinal axis LI. The body 142 further comprises a peripheral wall 148 extending from the first container-facing surface 144 to the second container-facing surface 146.

In some embodiments, the fluid transfer system 10 comprises a second barrier 150 positioned at least partially within the fluid flow path 18. The second barrier 150 defines the isolated volume 20, which extends at least partially between the first barrier 24 and at least a portion of the second barrier 150. As seen in the example shown in Figs. 3-9, the second barrier 150 is disposed in the container adaptor 120, though it is appreciated that in some embodiments, the second barrier 150 may be disposed within the first container 12 or the second container 14.

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

The septum 152 is positioned at any suitable location within the fluid transfer system 10. In some embodiments, the septum 152 is positioned within the container adaptor 120 at least partially within the adaptor proximal end portion 132, as shown for example in Fig. 3.

In some embodiments, the first barrier 24 is disposed distally along the longitudinal axis LI from the septum proximal surface 154. As mentioned herein, a portion of the septum 152 or the entire septum 152 may constitute the second barrier 150. In some embodiments, the septum distal surface 158 constitutes at least partially the second barrier 150, as seen in Fig. 5 A. In some embodiments, the septum proximal surface 156 constitutes at least partially the second barrier 150.

Providing the fluid transfer system 10 with the second barrier 150 allows for improved sealing of the isolated volume 20 as it extends in between the first barrier 24 and the second barrier 150.

Furthermore, forming the container adaptor 120 with the second barrier 150 facilitates forming the isolated volume 20 in between the first barrier 24 and the second barrier 150.

In some embodiments, the septum 152 may be formed of a resilient, pierceable material configured to be pierceable, once or repeatedly, by the fluid transfer conduit 30, e.g. a needle. The pierceable material of the septum 152 can further reduce the cross contamination and/or microbial ingress by cleaning the fluid transfer conduit 30 as it penetrates the septum material, prior to introduction of fluid transfer conduit 30 into the isolated volume 20 and in some embodiments during removal of the fluid transfer conduit 30 from the isolated volume 20. Furthermore, structuring the first barrier 24 with an opening 170 (Figs. 5A-9) operable to selectively and repeatedly transition from the closed to opened state and resume back to the closed state, allows the repeated use of the same fluid transfer conduit 30 to transfer fluid into a plurality of subsequent first containers.

In some embodiments, it is a particular feature of the present application that at least a portion of the isolated volume 20 is predefined in the container adaptor already prior to engagement of the second container 14 with the first container 12. Namely it is not the engagement of the first container 12 with the second container 14 that creates the isolated volume 20, rather the isolated volume 20 is already defined in the container adaptor 120 prior to engagement of the first container 12 with the second container 14. Accordingly, the isolated volume 20 is formed in the container adaptor 120 irrespective of the degree of the sealing connection between the first container 12 and the second container 14 and/or the container adaptor 120 and the second container 14.

In accordance with an embodiment of the present application, the operation of the fluid transfer system 10 may be performed in any suitable sequence or manner. In some embodiments, the fluid port 32 (Fig. 2) of the fluid transfer conduit 30 associated with the second container 14 is introduced into the isolated volume 20. Thereafter, the fluid 16 is discharged from the fluid port 32 into the isolated volume 20 and retained in the isolated volume 20 during the closed state. In some embodiments, the fluid transfer conduit 30 is positioned within the isolated volume 20 all during the fluid discharge therefrom thereby isolating the second container 14 from the first container 12 at least during transfer of the fluid 16.

The isolated volume 20 is filled by the discharged fluid until a predetermined opening threshold is reached prompting the first barrier 24 to transition from the closed state, in which the fluid flow from the isolated volume 20 is prevented, to the opened state. In the opened state the fluid flow from the isolated volume 20 is allowed at least in the direction XI extending from the isolated volume 20 to the first container 12.

In a non-limiting example, the fluid transfer system 10 comprises a dilution system for diluting a substance, solid and/or liquid, in a vial. The vial may constitute the first container 12 and a syringe may constitute the second container 14. The fluid transfer conduit 30 comprises a needle formed with a port 32 for release of the fluid therefrom into the isolated volume 20. The fluid comprises a dilutant which is inserted into the syringe in any suitable manner, such as from an IV bag or any other container containing the dilutant. As shown in Fig. 4A, the fluid transfer system 10 and its operation facilitates uncontaminated, repeated transfer of fluid from the fluid port 32 into a plurality of first containers 12, e.g. into an initial first container 12A connected to an initial container adaptor 120 A and thereafter into the subsequent first container 12B connected to a subsequent container adaptor 120B, while isolating the fluid transfer conduit 30 from both the initial and subsequent first containers, 12A and 12B respectively.

At first, the initial first container 12A is filled with the fluid from the second container 14 via the fluid transfer conduit 30 as described herein, namely by discharging the fluid into the isolated volume 20A of the initial container adaptor 120A and selectively allowing the fluid to flow from the isolated volume 20A through the first barrier 24 A into the exposed volume 28 A to the initial first container 12 A.

Thereafter, the fluid transfer conduit 30 is removed from the isolated volume 20 A of the initial container adaptor 120 A. Either immediately thereafter or after a prolonged timed period, the same fluid transfer conduit 30 is subsequently introduced within an isolated volume 20B of the subsequent container adaptor 120B. The fluid from the second container 14 is discharged from the fluid port 32 into the subsequent isolated volume 20B. Similar to that described with reference to the initial first container 12A, the subsequent first container 12B then receives the fluid from the second container 14 via the fluid transfer conduit 30, namely by discharging the fluid into the isolated volume 20B of the subsequent container adaptor 120B and selectively allowing the fluid to flow from the isolated volume 20B through the first barrier 24B the into the exposed volume 28B to the subsequent first container 12B.

Accordingly, the same fluid transfer conduit 30 associated with the same second container 14 can be used repeatedly to transfer fluid into a plurality of subsequent first containers while preventing or minimizing cross-contamination and/or microbial ingress, in virtue of the first barrier’s act of isolation of the fluid transfer conduit 30 from the first container 12.

The repeated fluid transfer can be employed in a system for cross-contaminant reduced dilution of a substance in at least an initial vial and a subsequent vial, diluted by discharging a dilutant fluid from a fluid port 32 of a fluid transfer conduit 30 comprising a needle associated with a syringe. At first the initial vial is filled with the fluid from the syringe via the needle as described herein, namely by discharging the fluid into the isolated volume 20A of the initial vial adaptor and selectively allowing the fluid to flow from the isolated volume 20A into the exposed volume 28A to the initial vial.

Thereafter the needle is removed from the isolated volume 20A of the initial vial adaptor. Either immediately thereafter or after a prolonged timed period, the same needle is subsequently positioned within an isolated volume 20B of a subsequent vial adaptor connected to the subsequent vial. The fluid from the syringe is discharged from the fluid port 32 into the subsequent isolated volume 20B. As described with reference to the initial vial, the subsequent vial is filled with the fluid from the syringe via the fluid transfer conduit 30, namely by discharging the fluid into the isolated volume 20B of the subsequent vial adaptor and selectively allowing the fluid to flow from the isolated volume 20B into the exposed volume 28B of the subsequent vial.

As shown in Figs. 1A-4B, in accordance with an embodiment of the present application, the fluid transfer system and its operation facilitates needleless flow into the first container 12 from the isolated volume 20. For example, when the fluid transfer system comprises a dilution system, as described, and the fluid transfer conduit comprises a needle associated with a syringe, the fluid is initially discharged from the needle port into the isolated volume and thereafter flows from the isolated volume 20 into the vial needelessly by flowing through the opening 170 (Fig. 5 A) of the first barrier.

In some embodiments the fluid transfer may be performed manually.

As described in reference to Fig. 4B, in some embodiments, at least portions of the fluid transfer may be performed automatedly, e.g. by a robotic system 162 operable for transfer of the fluid in between the first container 12 and the second container 14. The robotic system 162 comprises a controller 164 and a manipulator 166 controllable by the controller 162 and configured to manipulate at least the second container 14. The controller 162 is configured to operate the manipulator 166 to position the fluid port 32 within the isolated volume 20 at a predetermined distance Y1 from at least the first barrier 24 and maintain the fluid transfer conduit 30 isolated from the first container 12 at least during fluid transfer from the second container 14 to the first container 12.

Employing the manipulator 166, which is partially or entirely automatically controlled by the controller 162, provides increased precision when positioning an end portion 168 of the fluid transfer conduit 30, including the fluid port 32, within the isolated volume 20 at the predetermined distance Yl. Precise positioning of the end portion 168 may be significant particularly when the isolated volume 20 is relevantly small with respect to the entire fluid transfer conduit 30 and the end portion 168 must be confined within the isolated volume 20. In a non-limiting example, the isolated volume 20 is formed with a height of about 4 millimeters and the end portion 168 is inserted into the isolated volume 20 to an extent in the range of about 2-2.5 millimeters, at a distance Y1 of about 1.5-2 millimeters from the first barrier 24.

Furthermore, the manipulator 166 is configured to direct the fluid transfer conduit 30 to penetrate at least a portion or even the entire extent of the second barrier 150 so as to allow the end portion 168 to reach the isolated volume 20.

In some embodiments, the robotic system 162 comprises a driving actuator configured for actuating the movement of the manipulator 166. The driving actuator may comprise in a non-limiting example any one of a motor, a direct linear motor, a servo motor, a hydraulic motor, a pneumatic motor, an electric motor, a magnetic motor, a mechanical actuator such as a spring, a piston and/or a combination thereof.

In some embodiments, the robotic system 162 may further comprise a sensor 180, such as an optical sensor, e.g. a camera and/or an encoder (such as an encoder of any one of the motors) or any other type of magnetic sensor, vibrational sensor, accelerometer, audio sensor, electrical sensor or any sensor configured for guiding the driving assemblies for executing the movement of the manipulator 166 so as to position the fluid transfer conduit 30 within the isolated volume 20 or a sensor configured for detecting information related to any one or more of the container adaptor 120, first container 12 and the second container 14.

In some embodiments, the manipulator 166 is configured to aspirate the fluid from the first container 12 into the second container 14 via the first barrier 24. The manipulator 166 moves the fluid transfer conduit 30 to pierce the first barrier 24 to penetrate therethrough and thereafter position the fluid port 32 within the exposed volume 28 for aspirating the fluid from the first container 12. Alternatively or additionally, aspiration may be performed by use of a bidirectional first barrier as will be described in reference to Figs. 8A-C.

In some embodiments, the robotic system 162 comprises a robotic pharmaceutical preparation system configured for transferring pharmaceuticals for preparation thereof.

In reference to any one of the embodiments of Figs. 1A-9, it is appreciated that the container adaptor 120 may be configured to be connected to the second container 14, and may be formed as a syringe connector or any other type of connector. The syringe connector comprises the features described with reference to the container adaptor 120 and attachment means configured for attachment to the syringe 102.

It is further appreciated that in some embodiments, the container adaptor is configured to facilitate flow of the fluid at least from the first container 12 to the second container 14 and the isolated volume 20 extends from the first barrier 24 towards the first container 12 and is isolated from the second container 14. The exposed volume 28 extends from the first barrier 24 towards the second container 14 and is exposed to and in fluid communication with the second container 14. The first barrier 24 is configured to be selectively displaceable between the closed state operable to prevent fluid flow therethrough and the opened state operable to allow fluid flow therethrough at least in a direction extending from the first container 12 to the second container 14.

In a non-limiting example, the fluid transfer system 10 comprises an aspiration system for aspirating a liquid from a vial, which may constitute the first container 12, into a syringe, which may constitute the second container 14, via the fluid transfer conduit 30 comprising the needle formed with the port 32. The liquid is typically a diluted substance. The aspiration may be performed by piercing first barrier 24 with the needle to access the fluid within the vial. Alternatively or additionally, aspiration may be performed by use of the bidirectional first barrier, as will be described in reference to Figs. 8A-C.

Reference is made to Figs. 5A-9, which are embodiments of exemplary container adaptors 120 described in reference to Figs. 1A-4B. The first barrier 24 is configured as a valve 200 or a portion of a valve 200, comprising a chamber 210 at least partially defining the isolated volume 20 and configured for receiving the fluid transfer conduit 30 (Fig. 2) therein. The first barrier 24 is formed with the opening 170 configured to open upon transitioning from the closed state to the opened state and to reclose upon transitioning from the closed state to the opened state. In some embodiments at least a portion of the isolated volume 20 and/or the first barrier 24 constitute the valve 200.

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

In reference to all embodiments described herein, the opening 170 is configured to transition in between the closed and opened state in response to any suitable prompt e.g., a mechanical force.

In some embodiments, such as when the first barrier 24 comprises the valve 200, the first barrier 24 is configured to displace from the closed state to the opened state in response to a pressure differential applied thereacross. The pressure differential, shown as arrow 222 in Fig. 5A, can be applied across the first barrier 24 in the direction XI (Fig. IB) of the fluid flow during the fluid transfer, which is generally parallel to longitudinal axis LI. Alternatively, the pressure differential may be applied angularly with respect to longitudinal axis LI.

The first barrier 24 may be configured to displace from the closed state to the opened state upon an increase of pressure in the isolated volume 20 beyond a predetermined opening pressure threshold. Likewise, the first barrier 24 may be configured to displace from the opened state to the closed state upon a decrease of pressure in the isolated volume 20 to below a closing predetermined threshold.

It is noted that the predetermined opening pressure threshold may be referred to as a cracking pressure, namely the pressure causing the opening 170 to “crack open”, and the predetermined closing pressure threshold may be referred to as a resealing pressure, namely the pressure causing the opening 170 to reseal.

The increase and/or decrease in pressure may be due to the fluid discharged into the isolated volume 20 by the second container. In some embodiments, as the liquid fills the isolated volume 20, pressure is exerted on the second container-facing surface 146 (Fig. 3) until reaching the predetermined opening threshold, in a nonlimiting example, when the isolated volume 20 is filled with fluid to its majority, such that over 50% of the isolated volume 20 is filled by the fluid. Thus, the opening 170 is urged to open, typically towards the first container 12 and allow the fluid to flow from the isolated volume 20 to the exposed volume 28.

Upon reaching the predetermined closing threshold, the opening 170 recloses and transitions back to the closed state. In a non-limiting example, the predetermined closing threshold is reached when the fluid is at least mostly drained from the isolated volume 20, e.g. to contain 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.

Additionally, or alternatively, the fluid transfer conduit 30 applies an impelling force on the first barrier 24 as it discharges the fluid therefrom, causing the pressure to increase until reaching the predetermined opening threshold. Thus, the opening 170 is urged to open, typically towards the first container 12 and allow the fluid to flow from the isolated volume 20 to the exposed volume 28. Once the discharge of fluid from the fluid transfer conduit 30 is ceased, the isolated volume pressure decreases. Upon reaching the predetermined closing threshold, the opening 170 recloses and transitions back to the closed state.

The predetermined opening threshold and the predetermined closing threshold may be the same or different. In some embodiments, the predetermined opening threshold and the predetermined closing threshold are the same. In some embodiments, the predetermined closing threshold is slightly lower than the predetermined opening threshold, such as in a non-limiting example, by less than 0.1 bar.

In some embodiments, the predetermined closing threshold is significantly smaller than the predetermined opening threshold. Accordingly, the first barrier 24 is configured to transition from the closed to the opened state at the predetermined opening threshold pressure, and upon dropping to the predetermined closing threshold pressure, the first barrier 24 is configured to resume from the open to the closed state.

In a non-limiting example, when the fluid transfer system 10 comprises a dilution system, the fluid discharged into the isolated volume 20 of a vial adaptor may be a dilutant. The dilutant may be discharged from a port of the needle of the syringe. As the dilutant fills the isolated volume 20 in its closed state, the pressure on the first barrier 24 increases. Once the pressure in the isolated volume 20 reaches the predetermined opening threshold, the opening 170 transitions to its opened state and the dilutant flows into the exposed volume 28, typically defined within the vial.

In accordance with some embodiments, the predetermined opening threshold is a measure of pressure and is determined in any suitable manner. In some embodiments, the predetermined opening threshold is determined based on at least the degree of openability of the first barrier 24, namely the propensity of the first barrier 24 to transition from the closed state to the opened state upon application of pressure thereon. The degree of openability of the first barrier 24 may be dependent on one or more properties of the isolated volume 20 and/or the first barrier 24.

In some embodiments, the properties may include the dimensions and/or shape of the isolated volume 20. For example, the pressure in a smaller isolated volume 20 increases more rapidly than in a larger isolated volume 20, causing the first barrier 24 to transition faster from the closed state to the opened state when in communication with the smaller isolated volume 20.

In some embodiments, the properties may include the degree of the first barrier body material toughness, which may be defined as the ability of the material to withstand loading thereon or pressure applied thereon. For example, a tougher material, namely a material with a greater ability to withstand the pressure applied thereon and typically with a higher degree of hardness and/or higher degree of ductility, will lead to lesser openability. This will cause the first barrier 24 to transition from the closed state to the opened state at a slower rate than a material with a lesser degree of toughness.

In some embodiments, the properties may include the distribution of the first barrier body material at least along the lateral axis L2. For example, for a first barrier 24 with the opening 170 centrally positioned therein, a lesser amount of material towards the central portion 172 of the first barrier 24 along the lateral axis L2, will increase its openability in comparison with a first barrier 24 with a larger amount of material in the central portion 172.

In some embodiments, the properties may include the orientation of the first barrier body 142 with respect to the direction of the fluid flow XI (Fig. IB). For example, as shown in Fig. 5A, when the first barrier body 142 at the central portion 172 is structured generally convexly thereby bulging in the direction of the fluid flow XI, the opening 170 will more readily open in the same direction allowing the fluid to flow therethrough. This is in comparison with a first barrier body, which is structured generally concavely thereby bulging at the central portion 172 oppositely to the direction of the fluid flow XI or structured to be generally flat, and thus the opening 170 will less readily open in flow direction XI.

In some embodiments, the properties may include the size of a contact area 230 formed between the first barrier peripheral wall 148 and a corresponding wall 232 of the interior portion 140 of the container adaptor 120. In some embodiments, the corresponding wall 232 presses upon the first barrier peripheral wall 148 at the contact area 230, thereby applying a medial force Fl in the orientation of lateral axis L2, namely the force Fl is applied inwardly towards the central portion 176. Force Fl urges the opening 170 to remain in a closed state. Accordingly, a larger contact area 230 and a greater degree of sealing between the first barrier peripheral wall 148 and corresponding wall 232, yields a larger medial force Fl. A larger medial force Fl increases the resistance of the opening 170 to transition from the closed state to the opened state.

In some embodiments, the predetermined closing threshold is a measure of pressure and is determined in any suitable manner. In some embodiments, the predetermined closing threshold is determined based on at least the propensity of the first barrier 24 to transition from the opened state to the closed state.

The propensity of the first barrier 24 to close may be dependent on one or more properties of the isolated volume 20 and/or the first barrier 24.

In some embodiments, the properties may include the dimensions and/or shape of the isolated volume 20. For example, the pressure in a smaller isolated volume 20 increases more rapidly than in a larger isolated volume 20, causing the first barrier 24 to transition at a slower rate from the opened state to the closed state when in communication with the smaller isolated volume 20.

In some embodiments, the properties may include the degree of the body material resilience, which may be defined as the ability of the material to resume to its original state prior to application of pressure thereon. For example, a more resilient material, will lead to a greater propensity to close. This will cause the first barrier 24 to transition from the opened state to the closed at a faster rate than a material with a lesser degree of resilience.

In some embodiments, the properties may include the distribution of the first barrier body material at least along the lateral axis L2. For example, for a first barrier 24 with the opening 170 centrally positioned therein, a greater amount of material towards the central portion 172 of the first barrier 24 along the lateral axis L2, will increase its propensity to close in comparison with a first barrier 24 with a smaller amount of material in the central portion 172.

In some embodiments, the properties may include the orientation of the first barrier body 142 with respect to the direction of the fluid flow XI. For example, when the first barrier body at the central portion 172 is structured to bulge concavely opposite the direction of the fluid flow XI or away from the flow direction XI or without a bulging portion, the opening 170 will more readily remain closed at least in the fluid flow direction XI, thereby preventing the fluid flow therethrough.

In some embodiments, the properties 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 corresponding wall 232, yields a larger medial force Fl. A larger medial force Fl increases the propensity of the first barrier 24 to remain in a closed state and/or to transition from the opened state to the closed state.

As described herein the first barrier 24 and/or the valve 200 may assume any suitable structure configured for transitioning between the open and closed state. Figs. 5 A-9 illustrate a number of exemplary embodiments of different types of first barriers 24, also referred to here as valves.

As seen in Figs. 5A-6, the first barrier body 24 is arranged to increase along lateral axis L2, starting from the opening 170, where the body thickness is relatively thin and thickening as the body extends laterally towards the peripheral wall 148. As described herein, this structure enhances the degree of openability of the valve 200.

The opening 170 is shown to be formed as the slit 218 formed at the central portion 172 of the valve 200.

In some embodiments, the chamber 210 is configured to extend from the second container-facing surface 144 (Fig. 3) and terminate at the septum distal surface 158 and/or in proximity thereto, as seen in Fig. 5A and 6.

It is noted that in some embodiments, the chamber 210 is configured to extend from the second container-facing surface 144 and terminate at the septum proximal surface 156 and/or in proximity thereto.

In the embodiments of Figs. 5A-6 the first barrier 24 is at least partially defined by the valve 200 or at least by a portion of the valve comprising the central portion 172. The second barrier 150 is at least partially defined by the septum 152 or at least by the septum distal surface 158. In the embodiment of Figs. 5 A and 5B the valve 200 is configured similar to a dome-shaped valve and in the embodiment of Fig. 6 the valve 200 is configured similar to a duck billed-shaped valve.

The valve 200 may be disposed in the container adaptor 120 at any suitable location and may be connected thereto in any suitable manner. In some embodiments, the valve 200 may be formed with a flange 240 (Fig. 5B) formed with an overhanging lip 242 configured to be mounted upon a corresponding structure 250 (Fig. 6) formed to receive the flange 240. The valve 200 may be formed with at least one or more projections 252 protruding laterally from the peripheral wall 148. The projection 252 may be configured to extend towards the corresponding wall 232 of the container adaptor 120 and may serve as the aforementioned contact area 230. The projection 252 may protrude from any location along the peripheral wall 148, such as at a location aligned with the opening 170 along lateral axis L2. The projection 252 may be configured to be pressable by the corresponding wall 232 medially, towards the opening 170, in the orientation of force Fl, so as to maintain the opening 170 in the closed state until the predetermined opening threshold is reached. Upon reaching the predetermined opening threshold the projection 252 is pressed laterally against adaptor corresponding wall 232 allowing the opening 170 to transition from the closed state to the opened state.

As seen in Fig. 7, the valve 200 may be formed integrally within the septum 152. In such an embodiment, the chamber 210 is positioned within the septum 152, the isolated volume 20 includes the chamber 210 and extends towards the septum proximal surface 156. The opening 170, shaped as orifice 220, extends from the chamber 210 through to the septum distal surface 158. The exposed volume 28 extends from the septum distal surface 158 within the interior portion 140 of the container adaptor 120 towards the first container 12.

In some embodiments, the septum 152 is configured with a pierceable material allowing a fluid transfer conduit associated with the second container 14, e.g. the needle associated with the syringe, to penetrate the septum 152 to position the fluid port 32 (Fig. 2) within the chamber 210 or in proximity thereto to discharge fluid into the chamber 210.

In the embodiment of Fig. 7 the first barrier 24 is at least partially defined by a bottom surface 254 of chamber 210. The second barrier 150 is at least partially defined by an upper surface 256 of chamber 210.

In some embodiments, the septum 152 is formed with a single or plurality of projections 252 which serve as the aforementioned contact area 230, as described in reference to the projections 252 shown in Figs. 5 A - 6.

As described, the first barriers 24 shown in Figs. 5A-7 can be deployed for dilution in a dilution system. During dilution, the fluid transfer conduit 30, e.g. the needle associated with a syringe, is inserted into the isolated volume 20 while transferring the dilutant from the fluid port 32 into the vial via the opening 170. The dilutant is transferred through the first barrier 24, needlelessly, namely without the needle passing through the opening 170. As described, the isolation of the needle from the vial facilitates repeated use of the needle for dilution of substances in multiple vials, with minimal or no risk of cross contamination and/or microbial ingress. The valves 200 shown in Figs. 5A-7 are structured convexly, namely with a bias to open towards the vial. The convex structure allows fluid to flow from the syringe into the vial during the opened state and to resist opening in the opposite direction, thereby preventing fluid from inadvertently transferring from the vial into the isolated volume 20.

Aspiration may be performed for removal of the diluted substance from the vial by piercing the needle through the valve 200 at the opening 170 or at any other suitable location through the container-facing surface 144 and the second containerfacing surface 144 to ingress the exposed volume 28. Since during aspiration the needle may be a disposable needle after a single use, there may be in some embodiments, though not in all, less required vigilance in preventing crosscontamination.

The valves 200 shown in Figs. 5A-7 are configured substantially as a unidirectional valve. In some embodiments, as shown in Figs. 8A-C, the valve 200 may be structured as a bidirectional valve 280. The bidirectional valve 280 is selectively displaceable between the closed state and the opened state, which is operable to allow fluid flow therethrough in the direction extending from the first container to the second container and in the opposite direction. In 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 the syringe to the vial, and to further open when transferring fluid in the opposite direction from the first container 12 to the second container 14, such as during aspiration of a diluted pharmaceutical from the vial into the syringe.

As seen in Figs. 8B and 8C, the bidirectional valve 280 may assume any suitable structure such as a structure substantially symmetrical, at least at a portion thereof, with respect to the central plane P including lateral axis L2 and transversing the longitudinal axis LI. The first barrier 24 may be formed with the second container-facing surface 146 and the first container-facing surface 144 parallel thereto and further to central plane P. The central portion 172, surrounding the opening 170, is structured to be substantially symmetrical with respect to central plane P, resulting in the bidirectional valve 280 which is bidirectionally biased towards the first container 12 and the second container 14 substantially to the same degree. In some embodiments, the first barrier 24 is formed such that a distance along the longitudinal axis LI between the second container-facing surface 146 and the first container-facing surface 144 recedes at the central portion 172. Accordingly, the opening 170, which is defined at the thinnest portion of the first barrier 24, readily transitions from the close state to the opened state and vice versa.

In the bidirectional valve 280 the first barrier 24 is at least partially defined by the bidirectional valve 280 or at least by a portion thereof. The second barrier 150 is at least partially defined by the septum 152 or at least by the septum distal surface 158.

The bidirectional valve 280 may be disposed at any suitable location along the fluid flow path 18, such as at the disk-shaped bottom of the container adaptor 120, as seen in Fig. 8A. In some embodiments, the bidirectional valve may be disposed at the container adaptor the distal end portion 134.

An additional example for a bidirectional valve is shown in Fig. 9. In some embodiments, the septum distal surface 158 constitutes the first barrier 24 and the isolated volume 20 is defined at least partially within a slit 260 formed in the septum 152. The isolated volume 20 extends to the second barrier 150 which is defined at least partially the septum proximal surface 156. It is noted that in such an embodiment the isolated volume is relatively small as it is formed within the slit 260 within the septum 152.

As seen in Fig. 9, the slit 260 extends entirely through the septum body 154 from the septum proximal surface 156 to the septum distal surface 158. The fluid transfer conduit 30 (Fig. 2), e.g. a needle, can be inserted into the slit 260 and positioned in between the septum proximal surface 156 and the septum distal surface 158. A portion of the slit 260 proximal to the septum distal surface 158 serves as the opening 170. In such an embodiment, the portion of the septum 152 including an uppermost end of the slit 260 constitutes the second barrier 150.

Alternatively, the slit 260 extends from the septum distal surface 158 and terminates within the septum body 154 in between the septum proximal surface 156 and the septum distal surface 158. In such an embodiment, the septum body 154 may be formed of a pierceable material configured for receiving the fluid port 32, which can pierce into the septum body 154 to form the fluid flow path 18 for discharging the fluid from the fluid port 32 into the opening 170.

In the embodiment of Fig. 9, the septum peripheral wall 160, which in this embodiment comprises the first barrier peripheral wall 148, forms the contact area 230 with the corresponding wall 232 of the container adaptor 120. As described herein, the corresponding wall 232 presses upon at least a portion of the septum peripheral wall 160 at the contact area 230, thereby applying the medial force Fl (Fig. 5 A) in the orientation of lateral axis L2, urging the opening 170 to remain in a closed state. Upon reaching the predetermined opening threshold the septum peripheral wall 160 is pressed laterally against corresponding wall 230 allowing the opening 170 to transition from the closed state to the opened state.

In some embodiments, the septum body 154 may be formed with projections, such as projections 252 shown in Fig. 7.

It is noted that in Figs. 5A-9 though the first barrier 24 and/or the valve 200 are described as being positioned within a vial adaptor, it is appreciated that the first barrier 24 and/or the valve 200 may be positioned within any one or more of the following: an adaptor associated with the second container 14, such as within a syringe adaptor connectable with a syringe, within the syringe or any other container configured for transfer of fluid and/or element engaged therewith. In some embodiments, the first barrier 24 and/or the valve 200 may be disposed within an IV bag or within an adaptor associated with the IV bag, such as in a spike adaptor or within tubing associated with the IV bag.

While various inventive examples have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means, materials, or structure for performing the function, obtaining the results, or one or more of the advantages described herein, and each of such variations or modifications is deemed to be within the scope of the inventive examples described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be for example only and that the actual parameters, dimensions, materials, and configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive examples described herein. It is, therefore, to be understood that the foregoing examples are presented by way of example only and that, within the scope of the appended claims, equivalents thereto, and any claims supported by the present disclosure, inventive examples may be practiced otherwise than as specifically described and claimed. Inventive examples of the present disclosure are directed to 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, if such features, systems, articles, materials, compositions, kits, methods, and steps, are not mutually inconsistent, is included within the inventive scope of the present disclosure.

Examples disclosed herein may also be combined with one or more features, functionality, or materials, as well as complete systems, devices or methods, to yield yet other examples and inventions. Moreover, some examples, may be distinguishable from the prior art by specifically lacking one and/or another feature disclosed in the particular prior art reference(s); i.e., claims to some examples may be distinguishable from the prior art by including one or more negative limitations.

Also, as noted, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, examples may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative examples.

Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented anywhere in the present application, are herein incorporated by reference in their entirety. Moreover, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and ordinary meanings of the defined terms.

The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one example, to A only (optionally including elements other than B); in another example, to B only (optionally including elements other than A); in yet another example, to both A and B (optionally including other elements); etc.

As used herein in the specification 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” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.

As used herein in the specification and in the claims, the phrase “at least one,” in reference 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 each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “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”) can refer, in one example, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another example, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another example, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively.

Although various example embodiments have been described in detail herein, however, in view of the present disclosure many modifications are possible in the example embodiments without materially departing from the concepts of present disclosure. Accordingly, any such modifications are intended to be included in the scope of this disclosure. Likewise, while the disclosure herein contains many specific combinations, these specific combinations should not be construed as limiting the scope of the disclosure or of any of the appended claims, but are provided as a description pertinent to one or more specific embodiments that may fall within the scope of the disclosure and the appended claims. Any described features from the various embodiments disclosed may be employed in combination with other disclosed embodiments. In addition, other embodiments of the present disclosure may also be devised which lie within the scopes of the disclosure and the appended claims.

This disclosure provides various examples, embodiments, and features which, unless expressly stated or which would be mutually exclusive, should be understood to be combinable with other examples, embodiments, or features described herein.

Claims

2. The container adaptor according to claim 1, wherein the container adaptor comprises: a proximal end portion; a distal end portion extending, at least partially along a longitudinal axis of the adaptor, distally from the proximal end portion towards the first container, when connected to the container adaptor; and an interior 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 at least partially within the interior portion.

3. The container adaptor according to claim 1 or 2, wherein the first barrier has a first barrier body comprising: a first container-facing surface configured to face, at least partially, towards the first container when connected to the container adaptor; 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 second container-facing surface.

4. The container adaptor according to claim 2 or claim 3, when dependent on claim 2, wherein the first barrier is positioned in the fluid flow path intermediate the proximal end portion and the distal end portion.

5. The container adaptor according to claim 4, wherein the first barrier is positioned in the fluid flow path at a greater proximity to the proximal end portion than the distal end portion.

6. The container adaptor according to claim 4, wherein the first barrier is positioned in the fluid flow path at a greater proximity to the distal end portion than the proximal end portion.

7. The container adaptor according to claim 2 or any one of claims 3-6, when dependent on claim 2, wherein the first barrier is configured with a first barrier mounting element, mountable to a corresponding adaptor mounting element of the interior portion.

8. The container adaptor according to claim 7, wherein the first barrier mounting element comprises a flange mountable on the corresponding adaptor mounting element, which is formed with a recess configured to receive the flange.

9. The container adaptor according to claim 3 or any one of claims 4-8 when dependent on claim 3, wherein the first barrier peripheral wall is configured to be mountable to a corresponding adaptor wall of the container adaptor.

10. The container adaptor according to claim 9, when dependent on claim 2, wherein the corresponding adaptor wall of the container adaptor constitutes a wall of the interior portion.

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

12. The container adaptor according to claim 11, when dependent on claim 2, wherein the septum is disposed at least partially within the proximal end portion.

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

14. The container adaptor according to any one of claims 11-13, wherein the septum distal surface constitutes at least partially the second barrier.

15. The container adaptor according to any one of claims 11- 13, wherein the septum proximal surface constitutes at least partially the second barrier.

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

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

18. The container adaptor according to any one of claims 11-17, wherein the septum is configured to be at least partially pierceable by a fluid transfer conduit associated with the second container.

19. The container adaptor according to claim 18, wherein the septum is configured to be repeatedly pierceable by the fluid transfer conduit at least upon insertion of the fluid transfer conduit into the second barrier and removal therefrom.

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

21. The container adaptor according to any one of claims 1-20, wherein the isolated volume is configured to receive a fluid discharged by a fluid transfer conduit associated with the second container and retain the fluid therein during the closed state of the first barrier.

22. The container adaptor according to any one of claims 1-21, wherein the first barrier is configured to allow needleless flow of the fluid therethrough into the first container during the opened state of the first barrier.

23. The container adaptor according to any one of claims 1-22, wherein the first barrier comprises a pierceable material for allowing a fluid transfer conduit associated with the second container to at least partially pierce the first barrier so as to facilitate aspiration of fluid from the first container towards the second container.

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

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

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

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

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

29. The container adaptor according to claim 28, wherein the pressure differential is applied across the first barrier in the direction of the fluid flow during transfer thereof.

30. The container adaptor according to claim 24 or any one of claims 25-29 when dependent on claim 24, wherein the first barrier is configured to displace from the closed state to the opened state upon an increase of differential pressure between the isolated volume and the exposed volume beyond a predetermined opening pressure threshold.

31. The container adaptor according to claim 24 or any one of claims 25-30 when dependent on claim 24, wherein the first barrier is configured to displace from the opened state to the closed state upon a decrease of differential pressure between the isolated volume and the exposed volume to below a predetermined closing threshold.

32. The container adaptor according to claim 31, when dependent on claim 30, wherein the predetermined opening threshold and the predetermined closing threshold are the same.

33. The container adaptor according to claim 31, when dependent on claim 30, wherein the predetermined opening threshold and the predetermined closing threshold are different.

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

35. The container adaptor according to any one of claims 31-34, when dependent on claim 30, wherein the predetermined opening and closing thresholds correspond to a pressure within the isolated volume exerted on the first barrier.

36. The container adaptor according to claim 35, when dependent on claim 3, wherein the predetermined opening and closing thresholds correspond to a pressure within the isolated volume exerted on the second container-facing surface of the first barrier.

37. The container adaptor according to claim 30 or any one of claims 31-36 when dependent on claim 30, wherein the predetermined opening threshold is determined based on at least a degree of openability of the first barrier.

38. The container adaptor according to claim 31 or any one of claims 32-37 when dependent on claim 31, wherein the predetermined closing threshold is determined based on at least a degree of a propensity of the first barrier to close.

39. The container adaptor according to claim 37, when dependent on claim 3, wherein the predetermined opening threshold is determined based on one or more of: the dimensions and/or shape of the isolating volume; the properties of the first barrier body including at least one of: a body material toughness, a distribution of the body material at least along a surface lying on a plane transversing an axis parallel to the direction of the fluid flow and an orientation of the body with respect to the direction of the fluid flow; and a contact area formed between the first barrier peripheral wall and a corresponding wall of the adaptor.

40. The container adaptor according to claim 38, when dependent on claim 3, wherein the predetermined closing threshold is determined based on at least one or more of: the dimensions and/or shape of the isolating volume; the properties of the first barrier body including at least one of: the body material resilience, a distribution of the body material at least along a surface lying on a plane transversing 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; and a contact area formed between the first barrier peripheral wall and a corresponding wall of the adaptor.

41. The container adaptor according to claim 39 or 40, wherein a contact formed at said contact area is at least partially a sealed contact.

42. The container adaptor according to any one of claims 1-41, wherein the first barrier comprises an opening configured to open upon said displacement from the closed state to the opened state and to reclose upon transitioning from the closed state to the opened state.

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

44. The container adaptor according to claim 42 or 43, when dependent on claim 3, wherein the first barrier body is arranged to increase in its dimension lying on an axis parallel to the direction of the fluid flow, whereupon the material increase commences from the opening and gradually increases laterally towards the peripheral wall.

45. The container adaptor according to any one of claims 42-44, wherein the first barrier comprises a valve including: a chamber at least partially defining the isolated volume; and the opening.

46. The container adaptor according to claim 45, wherein the valve comprises any one of a duckbill-like shaped valve, a dome-like shaped valve, and a disk-like shaped valve.

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

48. The container adaptor according any one of claims 45-47, when dependent on claim 3, wherein the chamber extends from the second container-facing surface and terminates at the second barrier or in proximity thereto.

49. The container adaptor according to claim 48, when dependent on claim 11, wherein the chamber extends from the second container-facing surface and terminates at the septum distal surface or in proximity thereto.

50. The container adaptor according to claim 48, when dependent on claim 11, wherein the chamber extends from the second container-facing surface and terminates at the septum proximal surface or in proximity thereto.

51. The container adaptor according to claim 11 or any one of claims 12-44 when dependent on claim 11, wherein the septum at least partially constitutes the first barrier and the isolated volume is defined at least partially within a slit formed in the septum at least at the septum distal surface.

52. The container adaptor according to claim 51, wherein the slit terminates within the septum body in between the septum proximal surface and the septum distal surface and the septum body is formed of a pierceable material configured for receiving a portion of the second container.

53. The container adaptor according to claim 51, wherein the slit extends from the septum distal surface through to the septum proximal surface.

54. The container adaptor according to any one of claims 1-44, wherein the first barrier comprises a bidirectional valve selectively displaceable between said closed state and said opened state operable to allow fluid flow therethrough in said direction extending from the first container to the second container and in the opposite direction, during said transfer of fluid.

55. The container adaptor according to claim 3 or any one of claims 4-54 when dependent on claim 3, wherein the second container-facing surface and the first container-facing surface are parallel thereto and further to a plane transversing an axis parallel to the direction of the fluid flow.

56. The container adaptor according to claim 55 when dependent on claim 42, wherein a distance along said parallel axis between the second container-facing surface and the first container-facing surface recedes in the vicinity of the opening.

57. The container adaptor according to any one of claims 1-56, wherein at least a portion of the isolated volume is predefined in the container adaptor at least prior to engagement of the second container with the container adaptor.

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

59. A method for transfer of a fluid in 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 adaptor connectable to the first container, said container adaptor comprising: a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path and an isolated volume extending from the first barrier towards the second container and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during said transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container; positioning the fluid port within the isolated volume; and discharging of the fluid from the fluid port into the isolated volume, thereby causing the first barrier to displace into its opened state.

60. The method according to claim 59, wherein the container adaptor constitutes an initial container adaptor connectable to an initial first container, and further comprising: removal of the fluid port from the isolated volume of the initial container adaptor; positioning the fluid port within an isolated volume of a subsequent container adaptor connectable to a subsequent first container; and discharging the fluid from the fluid port into the subsequent isolated volume.

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

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

63. The method according to claim 62, wherein the aspirating comprises piercing the fluid transfer conduit at least through the first barrier.

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

65. A robotic system operable for transfer of a fluid in between a first container and a second container comprising a fluid transfer conduit formed with a fluid port, the first container connectable to a container adaptor comprising a fluid flow path configured to facilitate said transfer of fluid between the first container and the second container, a first barrier positioned at least partially within the fluid flow path and an isolated volume extending from the first barrier towards the second container and being configured to be in fluid communication with the second container and being isolated from the first container at least partially during said transfer of fluid, wherein the first barrier is selectively displaceable between a closed state operable to prevent fluid flow therethrough and an opened state operable to allow fluid flow therethrough at least in a direction extending from the second container to the first container, the system comprising: a controller; and a manipulator controllable by the controller and configured to manipulate at least the second container, the controller being configured to operate the manipulator to position the fluid port within the isolated volume at a predetermined distance from at least the first barrier and maintain the fluid transfer conduit isolated from the first container at least during fluid transfer from the second container to the first container.

66. The robotic system according to claim 65, wherein the container adaptor constitutes an initial container adaptor connectable to an initial first container, and further comprising the controller being configured to operate the manipulator to: remove the fluid port from the isolated volume of the initial container adaptor; position the fluid port within an isolated volume of a subsequent container adaptor connectable to a subsequent first container; and cause the discharge the fluid from the fluid port into the subsequent isolated volume.

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 positioned within the isolated volume all during the fluid discharge therefrom into the isolated volume.

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

69. The robotic system according to claim 68, wherein the aspirating comprises piercing the fluid transfer conduit at least through the first barrier.