Vial manipulator for use in robotic pharmaceutical preparation systems

Abstract

A vial manipulator for use in a robotic pharmaceutical preparation system, comprising: a manipulator body defining a main axis; a first vial holder pivotably coupled to the manipulator body and configured to receive and hold a vial assembly; a first pivot mechanism for pivoting the first vial holder around a first axis extending outward from the body in a first direction; a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain the retention of a vial assembly; and a second pivot mechanism for pivoting the second vial holder around a second axis extending outward from the body in a second direction different from the first direction. The vial manipulator may further include a rotation mechanism configured to rotate the manipulator body around the main axis.

Description

Technical Field

[0001] This application relates to a robotic pharmaceutical preparation system, and more particularly, to the operation of containers (such as vials) within a robotic pharmaceutical preparation system.

Background Art

[0002] U.S. Patent No. 9,804,586 discloses "a method of robot control, comprising the steps of providing a user interface for introducing data indicating a drug to be subjected to a reconstitution process; accessing an internal database to output a list of basic operations P1, P2, ..., Pi, ..., Pn used in the reconstitution process for the selected drug; sequentially executing the basic operations and operating a robot to move a container according to the instructions of the basic operations; measuring physical positions in space and dynamic parameters of the container during the movement of the container under the operation of the robot to create a list of registered data; comparing the measured positions and dynamic parameters in space with corresponding ones of the basic operation movements to select a list of eligible primitives when a sufficient approximation level is reached; creating the selected eligible basic operations together to generate instructions for a robot that enables complex movements including simple movements; and using the robot to shake the container according to the complex movement."

[0003] U.S. Patent No. 11246803 discloses "a vial pack configured to be attached to a vial containing a drug. The vial pack includes various mechanisms to facilitate uniform control of vials of various sizes in an automated dispensing system. The vial pack mechanism may include a vial recess for receiving a vial of a specific size and securing the vial within the vial recess. The mechanism may also include a cylindrical central portion, a vertical extension extending from the top of the cylindrical central portion, a gear extending from the cylindrical central portion, and a sealing member disposed within the cylindrical central portion. It may include a cylindrical projection configured to press against the partition wall of the vial to form a seal between the vial pack and the vial. The sealing member may be configured to receive a needle of a dispensing system that allows access to the vial." [Overview of the project]

[0004] A robotic pharmaceutical preparation system may comprise an automated or partially automated system comprising at least one manipulator at least partially controlled by a controller, and may further comprise one or more drive assemblies for generating the movement of the manipulator, as further described below.

[0005] A robotic pharmaceutical preparation system may be capable of performing any activity related to the preparation of a drug, such as a drug designated for administration to a patient, including, for example, compounding, dilution, reconstitution, transfer, filling, drawing, stirring, and / or other processes associated with drug preparation.

[0006] In some examples, a robotic drug preparation system may be configured to receive a drug vial, dilute or reconstitute the drug in the vial as needed, and then draw it out to obtain a specified amount of the drug. Optionally, the drug is then prepared for administration to a patient, for example, by transferring the drug to a syringe and / or intravenous (IV) bag.

[0007] A robotic pharmaceutical preparation system may include one or more fluid transfer modules, such as a fluid extraction module, a dilution module, and / or other fluid transfer modules. The components of the pharmaceutical preparation system may be arranged on a platform (e.g., a table, optionally a concave table, the inner surface of a hood), and at least some of the components may be movable relative to each other and / or relative to the platform. Movement of components may generally occur perpendicular to the platform, such as along the length and / or width dimensions of the platform, optionally above the platform, below the platform, or across the thickness of the platform, for example, through recesses formed within the platform, or across its edges.

[0008] A pharmaceutical preparation system may be deployed for the preparation of any type of pharmaceutical, including hazardous and non-hazardous pharmaceuticals prepared within a closed system. In a closed fluid transfer system deployed for the preparation of hazardous pharmaceuticals, measures are taken to prevent hazardous leakage of fluid and / or fumes from containers such as syringes, vials, and IV bags. Connectors or adapters may be used with the containers and / or generally at the fluid transfer interface of the system to ensure proper alignment and provide a secure connection during fluid transfer. For the purposes of this specification, when a connector or adapter is used with a container, the combination will be referred to herein as a container assembly. For example, a vial assembly described herein should be understood herein as a vial and a vial adapter / connector attached thereto. A manipulator may be configured to receive, hold, and manipulate not only a container (e.g., a vial) but also a container assembly (e.g., a vial with a vial adapter attached), according to some examples.

[0009] This application focuses on a vial manipulator for use in a robotic pharmaceutical preparation system. The manipulator can receive and hold multiple containers, such as vials. The manipulator may be configured to selectively manipulate each vial to pivot the vial to a selected orientation and / or to agitate (e.g., oscillate) the vial to mix its contents and / or to stably hold the vial in an optionally selected orientation to allow, for example, the insertion of fluid into the vial or the withdrawal of fluid from the vial. According to some embodiments, the vial manipulator is further configured to rotate relative to a platform (e.g., a table in a pharmaceutical preparation system) on which the vial manipulator is mounted, such that the position of the multiple vials held by the manipulator is corrected by rotation.

[0010] According to the first aspect, a vial manipulator for use in a robotic pharmaceutical preparation system is provided, the vial manipulator is, The manipulator body that defines the main axis, A first vial holder, pivotably coupled to the manipulator body and configured to receive and hold the vial assembly, A first pivot mechanism for pivoting the first vial holder around a first axis extending outward from the main body in a first direction, A second vial holder is pivotably coupled to the manipulator body and configured to receive and hold the vial assembly, The device includes a second pivot mechanism for pivoting a second vial holder around a second axis that extends outward from the main body in a second direction different from the first direction.

[0011] For the purposes of this explanation, the direction of extension of the pivot axis of a vial holder should be understood as following a vector that originates from the manipulator body and extends toward each respective vial holder. For example, the first direction in which the first pivot axis of a first vial holder extends outward from the body should be understood as following a vector that originates from the body and extends toward the first vial holder. Similarly, the second direction in which the second pivot axis of a second vial holder extends outward from the body should be understood as following a vector that originates from the body and extends toward the second vial holder. Likewise, any direction in which the pivot axis of a particular vial holder extends outward from the body should be understood as following a vector that originates from the body and extends toward that particular vial holder.

[0012] A vial manipulator, in which each vial holder is operable via its associated pivot mechanism, may provide the ability to selectively manipulate each vial assembly held by the holders. That is, each pivot mechanism may be configured to pivot the vial holder associated with it, or to stably hold a vial assembly, independently of the current state of the other vial holders. Examples of operating states that may be provided by such arrangements include repeatedly pivoting (stirring) one vial assembly while stably holding the other in any orientation; stirring both vial assemblies independently of each other in the same or different ways; stably holding both vial assemblies independently of each other in any orientation; and pivoting each vial to a selected orientation defined for each vial, for example, holding one vial upright and the other inverted.

[0013] It should be noted that a vial manipulator may contain more than two vial holders, such as 3, 4, 5, 6, 8, 10, or an intermediate number, larger or smaller. The vial holders may be arranged symmetrically with respect to the manipulator body, for example, defining equal angles between them (e.g., 180 degrees between vial holders when two vial holders are used, 90 degrees between vial holders when four vial holders are used). Alternatively, the vial holders may be arranged differently with respect to the manipulator body, for example, asymmetrically. The vial holders may be able to operate independently via their respective associated pivoting mechanisms, as described above for two vial holders.

[0014] Returning to the example of the two vial holders, in some embodiments, the first and second directions define an angle of at least 90 degrees between them. Optionally, the first and second directions define an angle of 180 degrees between them and are diametrically opposed to each other so that the first and second axes are directly aligned. In this arrangement, the vial holders can face in opposite directions to each other. In an example of a manipulator body having a rounded cross-sectional profile, the vial holders may be diametrically opposed to each other. In some embodiments where the manipulator body is molded to define multiple outer surfaces, each vial holder can extend from a different surface or plane of the manipulator body (i.e., the housing of the manipulator body). Optionally, the surface may be a flat surface.

[0015] In some embodiments, the first and second axes, around which the first and second vial holders can pivot, may be perpendicular to the main axis. Each of the first and second pivoting mechanisms may include a pivoting mounting portion for each vial holder to the manipulator body, and each of the first and second axes passes through its respective pivoting mounting portion.

[0016] In some embodiments, the vial manipulator may further comprise a pivoting / rotating mechanism configured to pivot / rotate the manipulator body around a spindle. The manipulator body may be mounted on a platform and rotatable relative to the platform by the rotation mechanism. Rotation of the manipulator body displaces the vial holders, potentially swapping their positions, or otherwise displacing each of the vial holders. It should be understood that, in this specification, the terms “turning” and “rotating” are used interchangeably for the movement of the manipulator body around the spindle. In other words, it should be understood that, in this specification, pivoting the manipulator body around the spindle by a pivoting mechanism includes rotating the manipulator body around the spindle, and therefore, a pivoting mechanism is also referred to as a rotation mechanism.

[0017] A vial manipulator, such as one described herein, configured to selectively pivot each vial assembly held by the manipulator and to rotate around the main axis of the manipulator body, can reduce or prevent the need to move vials between different stations or manipulators positioned at a distance from each other, since multiple processes can be performed on vials held by the same vial holder, and their position can be easily changed by the rotation of the manipulator body. Such an arrangement can reduce or prevent the need to pick up vials and transfer them, for example, to another manipulator or station at a different distance for further processing.

[0018] When a vial (or vial assembly) is held by a vial manipulator, as described herein, for example, one or more of the following processes can be performed without the need to lift and transfer the vial: keeping the vial holder stable to hold the vial in a selected orientation for diluting / reconstituting the contents of the vial; pivoting the vial holder to agitate the vial (e.g., by repeatedly pivoting the vial holder); keeping the vial holder stable to hold the vial in a selected orientation for drawing fluid from the vial; and so on. Reducing the need for multiple stations or manipulators contributes to a simpler and more compact system design, potentially resulting in a smaller footprint. Furthermore, performing multiple processes while the vial is held by the same vial holder can accelerate preparation time and provide a higher preparation rate.

[0019] Referring to the vial holder structure here, in some embodiments, each of the first and second vial holders is: A pivot plate is pivotably connected to the wall of the manipulator body in the pivot mounting section, A frame connected to and extending from a pivot plate, the frame being configured to receive and hold a vial assembly, may comprise: The pivot of the pivot plate is configured to carry the frame together, thereby changing the orientation of the vial assembly held by the frame.

[0020] Optionally, the frame may be fixedly connected to a pivot plate. Optionally, the frame may be at least partially open and may include a set of clamping arms extending into the frame to clamp at least a portion of a vial assembly.

[0021] In some examples, the frame can be directly connected to the body of the manipulator without a pivot plate, thereby forming a vial holder. In such examples, the connection between the frame and the body can be any suitable connection that allows the frame to pivot relative to the body. In some examples, the pivot plate can be located inside the body, with only the frame protruding outward. In some examples, the pivot plate can be located outside the body.

[0022] At least a portion of the vial assembly clamped by the clamp arm may include the top of the vial, or an adapter attached to the top of the vial, and the clamp arm is molded to snap into at least a portion of the vial assembly. The clamp arm is elastic and therefore may be configured to hold vials and / or vial adapters of different shapes and / or sizes (e.g., having different diameters).

[0023] In some embodiments, pivoting of the vial holder changes the orientation of the vial assembly from its initial upright orientation. In one example, the vial assembly can be pivoted to an inverted orientation and / or to any non-vertical orientation.

[0024] In some embodiments, a vial assembly held by any or each of the vial holders may be pivotably movable on a first plane and a second plane, each of which intersects and is perpendicular to a first axis and a second axis, respectively, and a third axis and a fourth axis extend through the first plane and the second plane, both of which are parallel to the principal axis, and in the initial orientation of the vial assembly held by the vial holder, the longitudinal axis of each vial assembly is aligned with the third axis and the fourth axis, respectively.

[0025] In some configurations, the pivoting mechanism may be configured to pivot the vial holder to orient the vial assembly such that the long axis of the vial assembly is at any selected angle with respect to the third axis. Alternatively, the pivoting mechanism may be configured to pivot the vial holder to orient the vial assembly at a plurality of predetermined angles between the long axis of the vial assembly and the third axis, such as 30 degrees, 90 degrees, 180 degrees, or intermediate, larger or smaller numbers of angles, and / or intermediate, larger or smaller degrees of angles.

[0026] In some embodiments, each of the first and second pivoting mechanisms includes an actuator for pivoting the vial holder. Alternatively, in some embodiments, a single actuator may be configured to drive both pivoting mechanisms. In examples having more than two vial holders and corresponding pivoting mechanisms, each pivoting mechanism can include a respective actuator for pivoting the corresponding vial holder. In examples having more than two vial holders and corresponding pivoting mechanisms, all or some of the pivoting mechanisms can include a single common actuator for pivoting the corresponding vial holders.

[0027] The actuator of the pivoting mechanism can be fully housed within the housing of the manipulator body. Alternatively, the actuator can be only partially housed within the housing. Alternatively, the actuator is external to the housing. Note that a plurality of actuators can be used to drive each pivoting mechanism.

[0028] In some embodiments, the two actuators of the first and second vial holders are arranged symmetrically side by side within the manipulator body housing.

[0029] The actuator may be equipped with a motor, and each vial holder driven by the actuator may be connected to the motor via a shaft bearing. Optionally, the motor may be a servo motor. Pivoting the vial holder by a selected angle can be achieved, for example, by pre-setting the encoder of the servo motor.

[0030] In some embodiments, the actuator may be controlled by a controller. The controller operates in the following modes, namely: a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial held by the vial holder, b. Orientation setting mode, which pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in a selected orientation to allow the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, The system may be configured to allow independent selection and operation of the first vial holder and the second vial holder according to one or more of the following.

[0031] When the controller controls the actuator according to the stirring mode, the controller can repeatedly pivot the vial holder such that the long axis of the vial assembly held by the vial holder defines a variable angle less than 90 degrees with respect to the opposite side of the third or fourth axis, for example, to cause the vial assembly to swing in a pendulum-like motion or rotational motion.

[0032] When the controller controls the actuator according to the orientation setting mode, the controller can control the actuator to pivot the vial holder so that the long axis of the vial assembly held by the vial holder defines a fixed angle of 0 to 180 degrees with respect to a third axis. In one example, the vial assembly held by the vial holder is inverted at an angle of 180 degrees.

[0033] In some embodiments, the controller may be further configured to control a rotation mechanism to set the rotational positions of the first and second vial holders. In one example where the first and second vial holders face each other, the positions of the first and second holders can be swapped by rotating the manipulator body by 180 degrees. Generally, the manipulator body can be rotated around the spindle by any selected angle, such as 30 degrees, 60 degrees, 90 degrees, 270 degrees, 320 degrees, or intermediate, greater, or smaller angles. Optionally, the rotation of the manipulator body follows a preset interval, such as 90-degree intervals, 60-degree intervals, 30-degree intervals, or intermediate, greater, or smaller intervals. Optionally, the preset interval is defined according to the number and / or arrangement of vial holders on the manipulator body.

[0034] The vial manipulator may constitute part of a robotic pharmaceutical preparation system, which further comprises a motion module configured to interface with a vial assembly held by the vial manipulator.

[0035] In some cases, the operating module may be a reconfiguration / dilution module, and the vial manipulator may be spatially positioned relative to the fluid insertion component of the reconfiguration / dilution module such that the vial assembly, held by one of the first and second vial holders, is aligned beneath the fluid insertion component. In such a configuration, the controller may be configured to operate the vial holder according to a fluid communication mode during the insertion of fluid into the vial assembly via the fluid insertion component.

[0036] Similarly, the operating module may be a fluid extraction module, and the vial manipulator may be spatially positioned relative to the fluid extraction component of the module such that the vial assembly held by one of the first and second vial holders is aligned above the fluid extraction component. In such a configuration, the controller may be configured to operate the vial holder according to the fluid communication mode while fluid is being extracted through the fluid extraction component.

[0037] In another example, the motion module may be an articulated arm, and the vial manipulator may be spatially positioned such that only one of the first or second vial holders is within the reach of the arm, while the other vial holder is outside the reach. In such a configuration, the rotation of the vial manipulator can swap the positions of the vial holders, moving the vial holder that was outside the reach into the reach of the arm, and moving the vial holder that was within the reach out of the reach.

[0038] In some cases, multiple motion modules, such as reconstitution / dilution modules, fluid extraction modules, and articulated arms, can be configured together with a vial manipulator as part of the same robotic pharmaceutical preparation system.

[0039] According to a second aspect, a method is provided for controlling a vial manipulator in a robotic pharmaceutical preparation system, wherein the vial manipulator comprises a manipulator body and a first vial holder and a second vial holder pivotably connected to the manipulator body, and the method is as follows: The first vial holder is selectively pivoted around a first axis that extends outward from the manipulator body in a first direction, The second vial holder is selectively pivoted in a second direction different from the first direction around a second axis extending outward from the manipulator body, Includes.

[0040] According to a third aspect, a vial manipulator for use in a robotic pharmaceutical preparation system is provided, the vial manipulator is, The manipulator body that defines the main axis, A first vial holder, pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, It comprises a rotation mechanism configured to rotate the manipulator body around a main shaft.

[0041] According to a fourth aspect, a method is provided for controlling a vial manipulator in a robotic pharmaceutical preparation system, the vial manipulator comprising a manipulator body having a main shaft, and a first vial holder and a second vial holder pivotably connected to the manipulator body, the method being, The first vial holder and the second vial holder accept the corresponding first vial assembly and the second vial assembly, Selectively pivoting at least one of the first vial holder and the second vial holder, This includes rotating the manipulator body around its main axis to change the positions of the first vial holder and the second vial holder.

[0042] Selectively pivoting the vial holder may involve repeatedly pivoting the first vial holder while keeping the second vial holder stationary to agitate the vial assembly held by the first vial holder. Optionally, fluid may be introduced into the second vial assembly held by the second vial holder before rotating the manipulator body.

[0043] Selectively pivoting the vial holder may include pivoting the first vial holder 180 degrees from its initial orientation to hold the first vial assembly in an inverted orientation. Optionally, fluid is drawn from the first vial assembly held by the first vial holder before rotating the manipulator body.

[0044] According to the fifth aspect, a robotic pharmaceutical preparation system is provided. vial manipulator, The manipulator body that defines the main axis, A first vial holder, pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A vial manipulator comprising a rotation mechanism configured to rotate the manipulator body around a main shaft, The rotating mechanism comprises an operating module having an operating area and configured to interface with a vial assembly in the operating area, wherein the rotating mechanism is configured to rotate the manipulator body to bring one of the first vial holder and the second vial holder into the operating area and to move the other of the first vial holder and the second vial holder out of the operating area.

[0045] In some cases, the operating module includes a fluid insertion component and / or a fluid extraction component. Optionally, the fluid insertion component and / or the fluid extraction component includes a syringe.

[0046] In some cases, the motion module comprises an articulated arm having a distal end configured to engage with a vial assembly. In this case, the operating area may include the area within the reach of the distal end of the arm. Optionally, the arm may engage (optionally lift and / or transfer) only vial assemblies currently within its reach (within the operating area), without being able to access other vial assemblies outside the operating area. Such an arrangement can improve system safety by reducing or preventing undesirable contact (or other engagement) of the arm with vial assemblies that are not currently intended to be transferred by the arm, such as a vial assembly currently being agitated, or a vial assembly that is filled with fluid or from which fluid is being drawn.

[0047] According to the sixth aspect, a robotic pharmaceutical preparation system is provided, vial manipulator, The manipulator body and A first vial holder configured to accept and maintain a vial assembly, wherein the first vial holder is pivotably coupled to the manipulator body, A vial manipulator comprising: a first pivot mechanism configured to pivot a first vial holder; The system comprises a motion module spatially positioned relative to a first vial holder and configured to hold fluid communication components for interfacing with the vial assembly, The first pivot mechanism pivots the first vial holder to the following state, namely, A vial assembly held by a first vial holder is in a first state in which it is oriented upright so that fluid communication with the fluid communication component is established for the insertion of fluid by the fluid communication component, A vial assembly held by a first vial holder is in a second state in which it is in an inverted orientation in which fluid communication with a fluid communication component is established in order to draw fluid through the fluid communication component, It is configured to take.

[0048] The fluid communication component may include a syringe. The syringe can be used to inject fluid into the vial assembly (for example, by pushing the plunger of a filled syringe) or to withdraw fluid from the vial assembly (for example, by pulling the plunger of the syringe).

[0049] A pharmaceutical preparation system may include a controller, the controller having the following operating modes, namely, (a) A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly, (b) An orientation setting mode that pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, (c) A fluid communication mode in which the vial holder is stably held in either the first or second state, It is configured to select and operate the vial holder according to one or more of the following.

[0050] The vial manipulator is a second vial holder configured to receive and maintain a vial assembly, the second vial holder further comprising a second vial holder pivotably coupled to the manipulator body, and a second pivot mechanism configured to pivot the second vial holder.

[0051] The vial manipulator may further include a rotation mechanism configured to rotate the manipulator body around the main axis of the manipulator body, thereby exchanging the positions of the first vial holder and the second vial holder. In some embodiments, the controller is further configured to command the fluid communication component to transfer fluid to the vial assembly while the first vial holder is operating according to fluid communication mode (c).

[0052] According to the seventh aspect, a vial manipulator for use in a robotic pharmaceutical preparation system is provided, the vial manipulator is, The manipulator body that defines the main axis, A first vial holder is pivotably coupled to a first surface of the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to a second surface of the manipulator body and configured to receive and maintain the vial assembly, It is a controller, and the controller has the following operating modes, namely, a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial held by the vial holder, b. Orientation setting mode, which pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in a selected orientation to allow the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, The system comprises a controller configured to independently select and operate the first vial holder and the second vial holder according to one or more of the following:

[0053] In some embodiments, two or more operating modes can be executed sequentially without removing the vial assembly from the vial holder.

[0054] In some embodiments, the system further comprises a rotation mechanism configured to rotate the manipulator body around a main shaft, and a controller further configured to control the rotation mechanism and synchronize the rotation with the operating mode.

[0055] It should be noted that all features described herein in relation to one embodiment may also apply to any of the other embodiments.

[0056] As used herein, “vial” may include a resealable container, for example, made of glass or plastic, containing a drug in liquid or powder form. A vial may be a single-use vial. A vial may be tubular or bottle-shaped, having a neck portion adjacent to the vial opening. A vial may be covered with a cap.

[0057] As used herein, “vial assembly” may include vials alone or vials to which vial adapters are attached. A partition for at least partially sealing access to the vial may be positioned as part of the vial itself and / or as part of the vial adapter. The partition may include a membrane, such as a pierceable membrane or a membrane having a closable passage defined through it.

[0058] Vial adapters may be used as part of a vial assembly as referred to herein. Vial adapters may include a device that can be attached to a vial to facilitate the transfer of the vial itself (by gripping the adapter instead of gripping the vial) and / or to facilitate the transfer of fluid into or from the vial. Vial adapters may provide closed access to the contents of the vial. Vial adapters may be single-use, sterile devices. Note that the terms “vial” and “vial assembly” may be used interchangeably throughout this application.

[0059] The fluid typically includes drugs, diluents, saline or water, or any other fluid used in drug preparation.

[0060] As used herein, “syringe assembly” may include only a syringe (such as a standard syringe) or a syringe with a connector attached. The syringe connector may be coupled to the hub of the syringe. The syringe connector may provide closed access and facilitate fluid transfer. Partitions may be configured as part of the syringe connector or mounted on the syringe connector so that the two partitions interface with each other when the syringe assembly and the vial assembly are engaged. Note that the terms “syringe” and “syringe assembly” may be used interchangeably throughout this application.

[0061] The above-described aspects and features of the subject matter of this disclosure, as well as additional aspects and features, are further specified in the embodiments of the subject matter of this disclosure presented below.

[0062] 1. A vial manipulator for use in a robotic pharmaceutical preparation system, wherein the vial manipulator is: The manipulator body that defines the main axis, A first vial holder, pivotably coupled to the manipulator body and configured to receive and hold the vial assembly, A first pivot mechanism for pivoting the first vial holder around a first axis extending outward from the main body in a first direction, A second vial holder is pivotably coupled to the manipulator body and configured to receive and hold the vial assembly, A second pivot mechanism for pivoting the second vial holder around a second axis that extends outward from the main body in a second direction different from the first direction, A vial manipulator equipped with the following features. 2. The vial manipulator according to Embodiment 1, wherein the first direction and the second direction define an angle of at least 90 degrees between them. 3. The vial manipulator according to Embodiment 1 or 2, wherein the first and second directions define an angle of 180 degrees between them and are diametrically opposed to each other so that the first axis and the second axis are directly aligned. 4. A vial manipulator according to any one of embodiments 1 to 3, wherein the first axis and the second axis are perpendicular to the principal axis. 5. A vial manipulator according to any one of embodiments 1 to 4, wherein each of the first and second pivot mechanisms is provided with a pivot mounting portion for each vial holder to the manipulator body, and the respective first and second shafts pass through the pivot mounting portion. 6. Each of the first vial holder and the second vial holder is: A pivot plate is pivotably connected to the wall of the manipulator body in the pivot mounting section, A frame connected to and extending from a pivot plate, the frame being configured to receive and hold a vial assembly, comprises: The pivot of the pivot plate is configured to carry the frame together, thereby changing the orientation of the vial assembly held by the frame, according to Embodiment 5 of the vial manipulator. 7. The vial manipulator according to Embodiment 6, wherein the frame is fixedly connected to the pivot plate. 8. The vial manipulator according to embodiment 6 or 7, wherein the frame is at least partially open and comprises a pair of clamping arms extending into the frame to clamp at least a portion of a vial assembly. 9. The vial manipulator according to Embodiment 8, wherein at least a portion of the vial assembly comprises the top of the vial or an adapter attached to the top of the vial, and the clamp arm is molded to snap into at least a portion of the vial assembly. 10. The vial manipulator according to any one of embodiments 1 to 9, further comprising a rotation mechanism configured to rotate the manipulator body around a main shaft. 11. The vial manipulator according to Embodiment 10, wherein the manipulator body is mounted on a platform and is rotatable relative to the platform by a rotation mechanism. 12. A vial manipulator according to any one of embodiments 1 to 11, wherein the pivot of the vial holder is configured to change the orientation of the vial assembly from an initial orientation in which the vial assembly is upright. 13. The vial manipulator according to Embodiment 12, wherein the vial assemblies held by each vial holder are pivotably movable on the respective first and second planes, each of which intersects and is perpendicular to the first and second axes, respectively, and the respective third and fourth axes extend through the first and second planes, both of which are parallel to the principal axes, and in the initial orientation of the vial assemblies held by the vial holders, the longitudinal axis of each vial assembly is aligned with the third and fourth axes, respectively. 14. A vial manipulator according to any one of embodiments 1 to 13, wherein each of the first and second pivot mechanisms comprises an actuator for pivotably moving the vial holder. 15. The vial manipulator according to embodiment 14, wherein the actuator is completely housed within the housing of the manipulator body. 16. The vial manipulator according to embodiment 15, wherein the actuators of the first vial holder and the second vial holder are arranged side by side symmetrically within the housing. 17. The actuator is controlled by a controller, as described in any one of embodiments 14 to 16 of the vial manipulator. 18. A vial manipulator according to any one of embodiments 14 to 17, wherein each actuator comprises a motor, and each vial holder is connected to the motor via a shaft bearing. 19. The controller operates in the following modes, namely: a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly held by the vial holder, b. Orientation setting mode, which pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in a selected orientation to allow the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, The vial manipulator according to Embodiment 17, configured to independently select and operate each of the first vial holder and the second vial holder according to one or more of the following. 20. The vial manipulator according to Embodiment 19, wherein the controller is configured to operate each of the first vial holder and the second vial holder according to all operating modes (a) to (c). 21. A vial manipulator according to Embodiment 19, dependent on Embodiment 13, wherein the controller operates the vial holder in accordance with stirring mode (a) by repeatedly pivoting the vial holder such that the longitudinal axis of the vial assembly held by the vial holder defines a variable angle less than 90 degrees with respect to the opposite side of the third or fourth axis, respectively, in order to cause the vial assembly to swing in a pendulum-like motion. 22. A vial manipulator according to Embodiment 19, dependent on Embodiment 13, wherein the controller operates the vial holder by pivoting the vial holder such that the longitudinal axis of the vial assembly held by the vial holder defines a fixed angle of 0 to 180 degrees with respect to a third axis or a fourth axis, respectively, according to orientation setting mode (b). 23. The vial manipulator according to Embodiment 22, wherein the pivoting of the vial assembly in orientation setting mode (b) is configured to invert the vial assembly at an angle of 180 degrees. 24. The vial manipulator according to Embodiment 17, dependent on Embodiment 10, wherein the controller is further configured to control a rotation mechanism to set the rotational positions of the first vial holder and the second vial holder. 25. The vial manipulator according to Embodiment 17, wherein the vial manipulator constitutes part of a robotic pharmaceutical preparation system, the robotic pharmaceutical preparation system further comprises a motion module configured to interface with a vial assembly held by the vial manipulator, and a controller further configured to control the motion module. 26. The vial manipulator according to Embodiment 25, wherein the operating module is a reconfiguration / dilution module comprising a fluid insertion component, and the vial manipulator is spatially positioned relative to the fluid insertion component such that each vial assembly held by one of the first vial holder and the second vial holder is positioned beneath the fluid insertion component. 27. A vial manipulator according to Embodiment 26, as dependent on Embodiment 19, wherein the controller is configured to operate the vial holder according to a fluid communication mode (c) in order to introduce fluid into the vial assembly via a fluid insertion component. 28. The vial manipulator according to Embodiment 25, wherein the operating module comprises a fluid extraction module having a fluid extraction component, and the vial manipulator is spatially positioned relative to the fluid extraction component such that a vial assembly held by one of a first vial holder and a second vial holder is positioned above the fluid extraction component. 29. A vial manipulator according to Embodiment 28, as dependent on Embodiment 19, wherein the controller is configured to operate the vial holder according to a fluid communication mode (c) in order to draw fluid through a fluid extraction component. 30. The vial manipulator according to Embodiment 25, wherein the operating module comprises an articulated arm, and the vial manipulator is spatially positioned such that only one of the first vial holder and the second vial holder is within the reach of the arm, and the other vial holder is outside the reach of the arm. 31. A method for controlling a vial manipulator in a robotic pharmaceutical preparation system, wherein the vial manipulator comprises a manipulator body and a first vial holder and a second vial holder pivotably connected to the manipulator body, and the method is: The first vial holder is selectively pivoted around a first axis that extends outward from the manipulator body in a first direction, The second vial holder is selectively pivoted in a second direction different from the first direction around a second axis extending outward from the manipulator body, Methods that include... 32. The method according to Embodiment 31, wherein the first direction and the second direction define an angle of at least 90 degrees between them. 33. The method according to Embodiment 31 or 32, wherein the first direction and the second direction define an angle of 180 degrees between them and are opposite to each other so that the first axis and the second axis are directly aligned. 34. The method according to any one of embodiments 31 to 33, wherein the first axis and the second axis are perpendicular to the principal axis. 35. The method according to any one of embodiments 31 to 34, wherein each of the first and second vial holders comprises a pivot plate pivotably connected to the wall of the manipulator body and a frame connected to and extending from the pivot plate, the frame being configured to receive and hold a vial assembly, and selective pivoting includes pivoting the pivot plate while carrying the frame, thereby changing the orientation of the vial assembly held by the frame. 36. A vial manipulator for use in a robotic pharmaceutical preparation system, wherein the vial manipulator is: The manipulator body that defines the main axis, A first vial holder, pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A rotation mechanism configured to rotate the manipulator body around the main shaft, A vial manipulator equipped with the following features. 37. The vial manipulator according to embodiment 36, further comprising: a first pivot mechanism for pivoting a first vial holder around a first axis extending outward from the main body in a first direction; and a second pivot mechanism for pivoting a second vial holder around a second axis extending outward from the main body in a second direction. 38. The vial manipulator according to embodiment 37, wherein the first and second axes are perpendicular to the principal axis. 39. Each of the first vial holder and the second vial holder is: A pivot plate is pivotably connected to the side wall of the manipulator body, A frame connected to and extending from a pivot plate, the frame being configured to receive and hold a vial assembly, comprises: The pivot of the pivot plate moves the frame to change at least partially the orientation of the vial assembly held by the frame, as described in any one of embodiments 36 to 38 of the vial manipulator. 40. A vial manipulator according to any one of embodiments 36 to 39, wherein the vial assemblies held by each vial holder are movable on a first plane and a second plane, the first plane and the second plane intersect with a first axis or a second axis, respectively, and both a third axis and a fourth axis, which are parallel to the principal axis, pass through and extend therefrom, the third axis and the fourth axis, respectively, and in the initial orientation of the vial assemblies held by each vial holder, the long axis of each vial assembly is aligned with the third axis and the fourth axis, respectively. 41. A vial manipulator according to any one of embodiments 36 to 40, wherein each of the first and second pivoting mechanisms comprises an actuator for pivoting a vial holder. 42. The actuator is controlled by a controller, as described in Embodiment 41 of the vial manipulator. 43. The controller operates in the following modes, namely: a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly held by the vial holder, b. Orientation setting mode, which pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in a selected orientation to allow the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, The vial manipulator according to embodiment 42, configured to independently select and operate each of the first vial holder and the second vial holder according to one or more of the following. 44. The vial manipulator according to embodiment 42, wherein the controller is further configured to control a rotation mechanism to set the rotational positions of the first vial holder and the second vial holder. 45. A method for controlling a vial manipulator in a robotic pharmaceutical preparation system, wherein the vial manipulator comprises a manipulator body having a main shaft, and a first vial holder and a second vial holder pivotably connected to the manipulator body, and the method is: The first vial holder and the second vial holder accept the corresponding first vial assembly and the second vial assembly, Selectively pivoting at least one of the first vial holder and the second vial holder, The manipulator body is rotated around its main axis to change the positions of the first vial holder and the second vial holder, Methods that include... 46. ​​The method according to Embodiment 45, wherein selective pivoting includes repeatedly pivoting the first vial holder while keeping the second vial holder stationary to agitate the vial assembly held by the first vial holder. 47. The method according to embodiment 46, further comprising inserting fluid into a second vial assembly held by a second vial holder before rotating the manipulator body. 48. The method according to Embodiment 45, wherein selective pivoting includes pivoting the first vial holder 180 degrees from its initial orientation to hold the first vial assembly in an inverted orientation. 49. The method according to embodiment 48, further comprising drawing fluid from a first vial assembly held by a first vial holder before rotating the manipulator body. 50. A robotic pharmaceutical preparation system, vial manipulator, The manipulator body that defines the main axis, A first vial holder, pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A vial manipulator comprising a rotation mechanism configured to rotate the manipulator body around a main shaft, A robotic pharmaceutical preparation system comprising: an operating module having an operating area and configured to interface with a vial assembly in the operating area, wherein the rotation mechanism is configured to rotate the manipulator body to bring one of the first vial holder and the second vial holder into the operating area and to move the other of the first vial holder and the second vial holder out of the operating area. 51. The system according to embodiment 50, wherein the operating module comprises a fluid insertion component and / or a fluid extraction component. 52. The system according to embodiment 51, wherein the fluid insertion component and / or fluid extraction component comprises a syringe. 53. The system according to embodiment 50, wherein the operating module comprises an articulated arm having a distal end configured to engage with a vial assembly. 54. The system according to embodiment 53, wherein the operating area includes the area within the reach of the distal end of the arm. 55. A robotic pharmaceutical preparation system, vial manipulator, The manipulator body and A first vial holder configured to accept and maintain a vial assembly, wherein the first vial holder is pivotably coupled to the manipulator body, A vial manipulator comprising: a first pivot mechanism configured to pivot a first vial holder; The system comprises a motion module spatially positioned relative to a first vial holder and configured to hold fluid communication components for interfacing with the vial assembly, The first pivot mechanism pivots the first vial holder to the following state, namely, A vial assembly held by a first vial holder is in a first state in which it is oriented upright so that fluid communication with the fluid communication component is established for the insertion of fluid by the fluid communication component, A vial assembly held by a first vial holder is in a second state in which it is in an inverted orientation in which fluid communication with a fluid communication component is established in order to draw fluid through the fluid communication component, A robotic pharmaceutical preparation system configured to take 56. The system according to embodiment 55, wherein the fluid communication component includes a syringe. 57. Equipped with a controller, the controller has the following operating modes, namely: (a) A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly, (b) An orientation setting mode that pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, (c) A fluid communication mode in which the vial holder is stably held in either the first or second state, The system according to embodiment 55 or 56, configured to select and operate the first vial holder according to one or more of the following. 58. A second vial holder configured to receive and maintain a vial assembly, wherein the second vial holder is pivotably coupled to the manipulator body, The system according to any one embodiment 55 to 57, further comprising a second pivoting mechanism configured to pivot a second vial holder. 59. The system according to embodiment 58, further comprising a rotation mechanism configured to rotate the manipulator body around the main shaft of the manipulator body, thereby exchanging the positions of the first vial holder and the second vial holder. 60. A vial manipulator for use in a robotic pharmaceutical preparation system, wherein the vial manipulator is The manipulator body that defines the main axis, A first vial holder is pivotably coupled to a first surface of the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to a second surface of the manipulator body and configured to receive and maintain the vial assembly, It is a controller, and the controller has the following operating modes, namely, a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial held by the vial holder, b. Orientation setting mode, which pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, A controller configured to independently select and operate each of the first and second vial holders according to one or more of the following: c. a fluid communication mode in which the vial holder is stably held in a selected orientation so as to enable the insertion of fluid into or withdrawal of fluid from a vial assembly held by the vial holder; A vial manipulator equipped with the following features. 61. The vial manipulator according to embodiment 60, which can sequentially execute two or more of the operating modes without removing the vial assembly from the vial holder. 62. The vial manipulator according to embodiment 60 or 61, further comprising a rotation mechanism configured to rotate the manipulator body around a main shaft, wherein the controller is further configured to control the rotation mechanism and synchronize the rotation with the operating mode. [Brief explanation of the drawing]

[0063] Embodiments are described herein, only as non-limiting examples, with reference to the accompanying drawings, in order to better understand the subject matter disclosed herein and to illustrate how it may actually be carried out. [Figure 1] This is a schematic diagram of a vial manipulator according to one embodiment of the subject matter of this disclosure. [Figure 2A] This is a schematic diagram of the pivoting motion of a vial assembly held by a vial holder according to an embodiment of the subject matter of this disclosure. [Figure 2B] This is a schematic diagram of the pivoting motion of a vial assembly held by a vial holder according to an embodiment of the subject matter of this disclosure. [Figure 2C] This is a schematic diagram of the pivoting motion of a vial assembly held by a vial holder according to an embodiment of the subject matter of this disclosure. [Figure 3A] This is a schematic diagram showing the arrangement of a vial holder coupled to the body of a vial manipulator according to an embodiment of the subject matter of this disclosure. [Figure 3B] This is a schematic diagram of the arrangement of a vial holder coupled to the body of a vial manipulator according to an embodiment of the subject matter of this disclosure. [Figure 3C] This is a schematic diagram showing the arrangement of a vial holder coupled to the body of a vial manipulator according to an embodiment of the subject matter of this disclosure. [Figure 3D] This is a schematic diagram showing the arrangement of a vial holder coupled to the body of a vial manipulator according to an embodiment of the subject matter of this disclosure. [Figure 4] This is a schematic diagram of the spatial arrangement of the operating module and vial manipulator in a pharmaceutical preparation system according to an embodiment of the subject matter of this disclosure. [Figure 5A] This is a schematic diagram of the interface between a vial manipulator and an operating module constituting a fluid communication module, according to an embodiment of the subject matter of this disclosure. [Figure 5B] This is a schematic diagram of the interface between a vial manipulator and an operating module constituting a fluid communication module, according to an embodiment of the subject matter of this disclosure. [Figure 6A] This is an isometric view of a vial holder pivotably connected to a vial manipulator according to one embodiment of the subject matter of the present disclosure. [Figure 6B] This is an isometric view of a vial holder pivotably connected to a vial manipulator according to one embodiment of the subject matter of the present disclosure. [Figure 7A] This disclosure shows a vial manipulator for holding a vial assembly in various orientations, according to embodiments of the subject matter of this disclosure. [Figure 7B] This disclosure shows a vial manipulator for holding a vial assembly in various orientations, according to embodiments of the subject matter of this disclosure. [Figure 8] This is an isometric view of a vial manipulator according to one embodiment of the subject matter of this disclosure. [Figure 9A] These are cross-sectional views of a vial manipulator according to an embodiment of the subject matter of this disclosure, such as those shown in Figures 7A and 7B. [Figure 9B] These are cross-sectional views of a vial manipulator according to an embodiment of the subject matter of this disclosure, such as those shown in Figures 7A and 7B. [Figure 10A] This is a schematic diagram of an arrangement according to one embodiment of the subject matter of the present disclosure, comprising a vial manipulator and an operating module constituting a reconstitution / dilution module. [Figure 10B] This is a diagram of an arrangement according to one embodiment of the subject matter of the present disclosure, comprising a vial manipulator and an operating module constituting a reconstitution / dilution module. [Figure 11A] This is a schematic diagram of an arrangement comprising a vial manipulator and an operating module constituting a fluid extraction module, according to one embodiment of the subject matter of this disclosure. [Figure 11B]This is a diagram showing an arrangement comprising a vial manipulator and an operating module constituting a fluid extraction module, according to one embodiment of the subject matter of this disclosure. [Figure 12] This is a side view of another vial manipulator structure according to one embodiment of the subject matter of this disclosure. [Figure 13] This is a schematic diagram of syringe assembly and vial assembly components used in a pharmaceutical preparation system and interfaced with each other, according to embodiments of the subject matter of this disclosure. [Figure 14A] This is an isometric view of a vial manipulator according to one embodiment of the subject matter of this disclosure. [Figure 14B] Figure 14A is an enlarged top view of the vial holder of a vial manipulator according to one embodiment of the subject matter of this disclosure. [Figure 15] An embodiment of the subject matter of this disclosure shows a vial manipulator for holding a vial assembly in various orientations. [Modes for carrying out the invention]

[0064] Refer to Figure 1, which is a schematic diagram of a vial manipulator according to one embodiment of the subject matter of this disclosure.

[0065] In one illustrated example, the vial manipulator 101 comprises a manipulator body 103 having a spindle MA. In some embodiments, the body 103 is elongated, and its length may correspond to the height of the vial assembly (for example, measured from the bottom of the vial to the top surface of the vial assembly). In one example, the body 103 may be at least the same length as the vial assembly. In some examples, the dimensions of the body 103 may be independent of the vial assembly. The manipulator body may be cylindrical, or may have a generally rounded profile, or instead may be rectangular, square, triangular, or generally have a polygonal profile defining multiple faces.

[0066] As further shown, the manipulator body 103 is rotatably mounted on the platform 105. For example, a rotating mechanism 107 comprising at least one actuator (e.g., a motor, not shown) is configured to rotate the manipulator body relative to the platform about the main axis of the manipulator body.

[0067] Multiple vial holders are connected to the manipulator body, and each vial holder is configured to receive and hold a vial assembly. In the illustrated example, two vial holders 109 and 111 are connected to the manipulator body. Note that the number of vial holders connected to and extending from the manipulator body may range from 1 to 4 vial holders, 1 to 10 vial holders, 2 to 4 vial holders, 2 to 6 vial holders, or an intermediate number, a larger number, or a smaller number.

[0068] Each vial holder is pivotable around its own pivot axis by a pivot mechanism 113 including one or more actuators, such as motors. As shown in the figure, vial holder 109 is pivotable around a first axis 1A extending outward in a first direction from the manipulator body, and vial holder 111 is pivotable around a second axis 2A extending outward in a second direction different from the direction of axis 1A from the manipulator body. In some embodiments, axes 1A and 2A are perpendicular to the main axis MA. For the purposes of this description, the first axis 1A should be understood as extending along a vector originating from the body 103 and extending toward the first vial holder 109, and the second axis 2A should be understood as extending along a vector originating from the body 103 and extending toward the second vial holder 111. In general, the pivot axis of a vial holder should be understood herein as extending along a vector that originates from the body and extends toward the vial holder.

[0069] In some embodiments, each of the vial holders extends from a different face of the housing of the manipulator body. In the particular embodiment shown in this figure, the vial holders are oriented opposite each other with respect to the manipulator body, and are oriented in opposite directions so that their pivot axes 1A and 2A are directly aligned.

[0070] In other embodiments, two or more vial holders may extend from the same plane of the manipulator body housing.

[0071] In the illustrated example, each vial holder includes a pivot plate 115 connected to the manipulator body by a pivot mounting section 117. Each pivot axis (axis 1A, 2A) of each vial holder passes through the pivot mounting section. Note that the structure of the pivot mounting section is not limited to a pivot plate, and other elements can be used that enable the pivoting of the vial holder and are molded so as not to interfere with the vial assembly during pivoting motion.

[0072] In the illustrated example, each vial holder includes a frame 119 connected to a pivot plate and extending therefrom, the frame being configured to hold a vial assembly 121. In some embodiments, the frame may be fixedly connected to the pivot plate such that the pivot of the plate moves the frame, and thereby moves the vial assembly held by the frame. In some embodiments, the frame may be rotatably connected to the pivot plate. The frame is generally configured to hold the vial assembly at any part of the assembly, and may hold either the vial itself (e.g., the neck portion, the opening portion) or a vial adapter attached to the vial.

[0073] Although vial holders are shown herein as comprising a pivot plate and a frame, it should be understood herein that in some examples, any, some, or all of the vial holder may consist solely of a frame pivotably attached directly to the body. In some examples, the pivot plate may be located within the body, and the frame may extend outward from there. In general, a vial holder may have any structure suitable for pivoting the vial assembly held therein.

[0074] In the initial orientation as defined herein for illustrative purposes, the vial assembly 121 held by the holder is in an upright orientation in which the top of the vial (or adapter mounted thereon) is perpendicular to the top of the bottom of the vial and extends along a third axis 3A (in the case of vial holder 109) or a fourth axis 4A (in the case of vial holder 111).

[0075] Each vial holder is configured to hold and move the vial assembly along its respective plane intersecting its pivot axis (axis 1A or 2A), with axes 3A and 4A extending within their respective planes.

[0076] The movement of each vial holder and the rotation of the manipulator body are controlled by at least one controller 123. The controller 123 can control the pivot mechanism 113 and the rotation mechanism 107 and can be programmed to synchronize their movements.

[0077] In an exemplary use of the vial manipulator, the controller is configured to operate the pivot mechanism to cause the corresponding vial holder to assume one of the following operating modes. a. A stirring mode in which the vial holder is repeatedly pivoted to agitate the vial assembly and mix its contents (e.g., powder and fluid (such as saline solution), two or more types of fluids, etc.). Optionally, the agitation is performed by the oscillating, pendulum-like, rotational, or arc-like motion of the vial holder. The stirring parameters, such as the duration of stirring, the degree of oscillating motion, the speed of motion, and / or other factors, may be selected according to the specific type of drug being mixed, such as in accordance with the formulation instructions. In some embodiments, the vial holder is pivoted so that the vial assembly held therein is stirred until the drug powder particles are no longer visible or only a small amount is visible. b. An orientation setting mode in which the vial holder is pivoted around its pivot axis to set the orientation of the vial holder, and thereby the orientation of the corresponding vial assembly. In one example, the vial holder is pivoted 180 degrees from its initial orientation to invert the vial assembly. The orientation of the vial assembly can be set with respect to axis 3A such that the major axis of the vial assembly, which is aligned along axis 3A in the initial position (0-degree pivot angle) and the inverted position (180-degree pivot angle), defines an angle α with respect to axis 3A. (Similarly, a second vial assembly is oriented with respect to axis 4A). c. A fluid communication mode in which the vial holder is stably held and the corresponding vial assembly is maintained in a selected orientation in order to enable the transfer of fluid into or from the vial. In the fluid communication mode, by optionally rotating the manipulator body around the main axis, the vial holder can be positioned so that the vial assembly is aligned with (e.g., vertically, horizontally, or obliquely) a fluid inlet or fluid outlet component of a pharmaceutical preparation system, thereby enabling the transfer of fluid between the two.

[0078] It should be noted that at least one controller may be configured to control each vial holder independently of the others and to select an operating mode for each specific vial holder. The controller may be configured to take into account the current operating mode of one of the vial holders and set the operating modes of the other vial holders accordingly. The controller may be further configured to optionally correlate with the operating mode of the vial holders to define the timing and / or degree and / or speed of the rotation of the manipulator body around the spindle.

[0079] For example, an example of the operation scheme for a vial manipulator including two vial holders is provided below. • Stir the first vial holder and stably hold the second vial holder in any orientation. • Stir both vial holders. • Stably hold both vial holders in the same or different orientations relative to each other. The first vial holder is agitated, the second vial holder is held stably, and then the manipulator body is rotated to swap the positions of the two vial holders. The manipulator body is rotated regardless of whether one or more vial holders are stable in any orientation or are being agitated.

[0080] Figures 2A to 2C are schematic diagrams of the pivoting motion of a vial assembly held by a vial holder according to embodiments of the subject matter of this disclosure. It should be understood herein that the schematic diagrams of the vial assembly in Figures 2A to 2C may include only the vial or the vial with an adapter attached.

[0081] In Figure 2A, the vial holder (not shown) is pivoted so that the corresponding vial assembly 201 pivots along the arc 203, optionally and repeatedly, relative to axis 3A, for example, so that the long axis or vial assembly axis VA pivots along the arc 203, in order to agitate the vial. The angle α formed between the long axis of the vial assembly 201 (vial assembly axis VA) and axis 3A may be in the range of 1 to 90 degrees on each side of axis 3A, for example.

[0082] In Figure 2B, a vial holder (not shown) is pivoted so that the corresponding vial assembly pivots from its initial upright orientation to an inverted orientation, and the vial assembly axis VA is aligned with axis 3A. Optionally, the vial assembly is maintained in the inverted orientation over time, for example, to enable fluid communication.

[0083] In Figure 2C, the vial assembly is pivoted from its initial upright orientation to a pivotal orientation that is optionally (over time) stably maintained, and the vial assembly axis VA defines an angle β with respect to axis 3A. The angle β may be in the range of, for example, 1 to 179 degrees.

[0084] Figures 3A to 3D are schematic diagrams showing the arrangement of a vial holder coupled to the body of a vial manipulator according to an embodiment of the subject matter of this disclosure.

[0085] For example, a vial manipulator as described herein may include a plurality of vial holders 301 connected to and extending from a manipulator body 303. Each vial holder is pivotable around an axis 305 that extends from the manipulator body in a direction different from the pivot axis of the other vial holders.

[0086] In the examples shown in Figures 3A and 3D, four vial holders are connected to the manipulator body and extend in different directions (for example, the frame of each vial holder extends radially outward in a different direction from the frames of the other vial holders). Optionally, the four vial holders can be arranged symmetrically at a 90-degree angle between adjacent vial holders.

[0087] In the example shown in Figure 3B, two vial holders are connected to the manipulator body and extend in different directions.

[0088] In the example in Figure 3C, two vial holders are connected to the manipulator body and extend directly across the manipulator body in opposite directions. For a cylindrical (or other circular contour) manipulator body, the two vial holders may be directly opposite each other.

[0089] While the manipulator body is shown in this specification as having a rounded contour (e.g., a circular or elliptical contour) in Figures 3A to 3C, it should be noted that other manipulator body contours, including polygonal contours or even arbitrary contours, are also intended, as shown in Figure 3D, for example.

[0090] Figure 4 is a schematic diagram of the spatial arrangement of the operating module and vial manipulator in a pharmaceutical preparation system according to an embodiment of the subject matter of this disclosure.

[0091] In this figure, a vial manipulator 401, as described elsewhere in this application, is shown as part of a pharmaceutical preparation system 403, comprising at least one operating module 405 configured to interface directly or indirectly with a vial assembly 407 held by the vial manipulator.

[0092] Some examples of the operation module 405 include the following: • Fluid communication modules, for example, modules configured for injecting fluid into a vial, or modules configured for withdrawing fluid from a vial. In some embodiments, the fluid communication module includes a syringe having a needle that is at least partially advanceable within a vial assembly for injecting fluid into a vial and / or withdrawing fluid from a vial. Optionally, the syringe is in fluid communication with a fluid container such as an IV bag. The syringe may be connected to the IV bag via selective connectors such as valves (e.g., one-way valves, two-way valves, three-way valves), stopcocks, selectors, or other connectors. An arm (e.g., an articulated robotic arm) or other moving element configured to engage with the vial assembly and optionally lift the vial assembly. The arm may be capable of transporting the vial assembly, for example, removing the vial assembly from a vial manipulator and / or carrying the vial assembly to the vial manipulator. For example, an imaging device, such as a camera, that can image a vial assembly for purposes such as determining / verifying the type of drug, verifying the amount of fluid in the vial, confirming the presence of particles in the vial, or verifying drug information from prescription tags or stickers. For example, a mounting / removal unit that allows connectors or adapters to be attached to or removed from vials. A labeling unit that can label or otherwise mark vials according to their contents.

[0093] In some embodiments, the motion module 405 operates within a defined zone of the system, schematically shown as an operating region 409. The operating region may define a limited surface area and / or limited volume where an interface is created between the motion module and the vial assembly held by the vial manipulator. In an example where the motion module comprises a robotic arm, the arm may have a defined operating radius such that system components within the operating radius are within the arm's reach, while components outside the operating radius are not reachable by the arm.

[0094] In the exemplary system configuration shown, the vial manipulator 401 is positioned relative to the operating module such that only some of the vial holders, such as vial holder 411, are positioned within the operating area, while other vial holders, such as vial holder 413, are positioned outside the operating area. In such a configuration, the manipulator body 415 is rotated around the main axis MA (optionally the long axis of the manipulator body) to reposition one vial holder within the operating area and the other vial holder outside the operating area.

[0095] A configuration in which the rotation of the manipulator body exchanges the spatial position of the vial holder (and the vial assembly held in the holder by it) can be advantageous in that the motion module can operate within a limited area without having to "reach" to a wider range to interface with the vial assembly. In the case of a robotic arm, such a configuration can enable the use of a shorter, more compact arm, potentially reducing the need to move the arm over a wider range, thereby "freeing" the arm to perform additional movements simultaneously.

[0096] In one example of use, using the operating modules that constitute the fluid injection component, for example, a vial assembly 407 held by a vial holder 411 can be injected with fluid through the fluid injection component. The manipulator body can then be rotated 180 degrees to position the vial holder 411 with the vial assembly 407 outside the operating area, and the vial holder 413 with its vial assembly 417 within the operating area. The vial assembly 407 can then be agitated to mix its contents, while the vial assembly 417 can be interfaced in the same way as the fluid injection component into which the fluid is injected.

[0097] Figures 5A and 5B are schematic diagrams of the interface between a vial manipulator and an operating module constituting a fluid communication module, according to an embodiment of the subject matter of this disclosure.

[0098] In Figure 5A, the vial manipulator 501 is positioned relative to the dilution / reconstitution module 519 of the pharmaceutical preparation system, which is configured for injecting fluid into the vial (for example, to reconstitute the drug to be contained in the vial).

[0099] The vial manipulator comprises one or more vial holders 503 (one is shown in the illustrated embodiment) connected to the body 505 of the vial manipulator, each holder comprising a pivot plate 517 pivotably connected to the body and a frame 511 extending away from the body from the pivot plate to hold the vial assembly 507. Pivoting of the pivot plate around a pivot axis 509 moves the frame and changes the orientation of the vial assembly. To interface with a dilution / reconfiguration module, the vial assembly is pivoted to an orientation in which the vial assembly is aligned with the fluid insertion component 515 of the dilution / reconfiguration module. In one example, the orientation is an upright orientation, in which the vial assembly is aligned vertically below the fluid insertion component.

[0100] Similarly, in Figure 5B, the vial manipulator is positioned relative to a fluid extraction module 521 configured to extract fluid from a vial (for example, to transfer fluid from the vial to an IV bag for administration to a patient). The vial holder is pivoted so that the vial assembly 507 is aligned with the fluid extraction component 525 of the fluid extraction module. In one example, the orientation is inverted, and the vial assembly is positioned perpendicularly above the fluid extraction component.

[0101] It should be noted that fluid transfer between the vial assembly and the fluid communication component can generally be performed when a direct alignment is obtained between them. Generally, for the insertion of fluid into the vial assembly, the vial assembly needs to be oriented such that the opening 527 of the vial is located upward, for example, so that the contents of the vial do not flow outward from the vial and the fluid flow into the vial is in the direction of gravity. For the withdrawal of fluid from the vial assembly, the vial assembly needs to be oriented such that the opening 527 is located downward, for example, so that the fluid is withdrawn from the vial and not gas, and the flow from the vial is in the direction of gravity.

[0102] It should be noted that the fluid insertion component 515 and the fluid withdrawal component 525 each generally comprise a container capable of holding fluid, and a force capable of injecting fluid from the container or drawing fluid into the container may be used in addition to this. Examples of containers include syringes, fluid bags, conduits or other tubes, and vials, and the force capable of injecting or drawing fluid may include pressure (e.g., applied by a pump), centrifugal force, gravity, and / or other suitable forces.

[0103] Figures 6A and 6B are isometric views of a vial holder pivotably connected to the body of a vial manipulator, according to one embodiment of the subject matter of this disclosure.

[0104] In Figure 6A, the vial holder 601 includes a pivot plate 603 pivotably mounted to the wall of the manipulator body 605. A frame 609 is fixedly connected to the pivot plate, extending outward from the plate and facing away from the manipulator body. The frame 609 is partially open, for example, U-shaped, to allow insertion of a vial assembly 611 (shown in Figure 6B). A pair of clamp arms 613 extend into the frame (the clamp arms are shown without the frame in Figure 6B for illustrative purposes). The clamp arms may be elastic (flexible) to tightly clamp the vial assembly received within the frame. Optionally, during insertion, the vial assembly is pressed or pushed onto the frame and clamped by the clamp arms. The vial assembly may be brought into the frame and inserted automatically, such as via a robotic arm or other automated transfer means, and / or manually, such as by an operator of a pharmaceutical preparation system.

[0105] As shown in the figure, the pivot plate is connected to the manipulator body such that the pivot axis 607 of the vial holder passes over the top of the manipulator body. The axial position of the pivot axis (along the length of the manipulator body) can be defined such that sufficient space remains above and below the pivot axis for the vial assembly to extend along it in both upright and inverted orientations of the vial assembly.

[0106] While frames having clamping arms are shown herein, it should be noted that reversible mounting of vial assemblies to frames can be performed using any suitable gripping means, such as clamps, grippers, snaps, fasteners, or frames of other shapes.

[0107] The frame is fixedly attached to a pivot plate, and as a result the frame pivots with the plate; however, it should be further noted that other embodiments may include mounting parts that allow at least some movement of the frame, for example, pivot mounting parts for the frame to a pivot plate that allow at least partial pivoting of the frame. In some examples, the frame may be directly connected to the manipulator body by any suitable connection arrangement that allows the frame to pivot and stir the vial assembly held by it. In some examples, the pivot plate may be located inside the manipulator body.

[0108] Figures 7A and 7B show vial manipulators for holding vial assemblies in various orientations according to embodiments of the subject matter of this disclosure. In the example of Figure 7A, two vial holders 701 and 705 are connected to the manipulator body 703, facing in opposite directions. The vial assembly 711 held in holder 701 is shown in its initial upright orientation. The vial assembly 713 held in holder 705 is slightly pivoted (for example, during agitation of the vial assembly, or when the vial assembly is held stably in a pivoted orientation for purposes such as fluid transfer). In the example of Figure 7B, both vial holders are pivoted 180 degrees to hold the vial assembly in an inverted (upside down) orientation.

[0109] Figure 8 is an isometric view of a vial manipulator according to one embodiment of the subject matter of this disclosure.

[0110] Generally, the pivot mechanism of a vial holder includes or is operably connected to one or more actuators, such as one or more motors, for driving the movement of the pivot plate of the vial holder relative to the manipulator body.

[0111] In some embodiments, the actuator is housed within the manipulator body. Additionally or alternatively, the actuator may be located outside the manipulator body and operably connected to a pivot plate.

[0112] In some embodiments, each actuator may be configured to drive the movement of the pivot plate of a single vial holder. Alternatively, the actuator may be configured to drive the movement of the pivot plates of two or more vial holders.

[0113] Actuators may include motors such as servo motors, hydraulic motors, pneumatic motors, electric motors, and magnetic motors, mechanical actuators such as springs and pistons, and combinations thereof.

[0114] In this example, the vial manipulator is shown with a portion of the external housing of the manipulator body 803 removed for illustrative purposes. Two motors 805, such as servo motors, are arranged side by side, each motor configured to drive the movement of the respective vial holder to which it is connected. Power is supplied to the motors via electrical cables 807 extending through a designated opening 809 defined in a rotatable platform 810 to which the manipulator body is mounted, as shown in the figure.

[0115] In some embodiments, as shown in this example, multiple motors (optionally each driving the movement of a different vial holder) are arranged symmetrically with respect to one another, for example, within the housing of the manipulator body. In one illustrated example, two motors are positioned back-to-back. In another example with four vial holders, the four motors are arranged symmetrically, for example, at 90-degree angles to each other. Other examples may include, for example, an alternating configuration of motors arranged along the length of the manipulator body, with multiple motors meshing with each other.

[0116] By arranging the pivot mechanism's actuators (e.g., motors) in a compact configuration, such as back-to-back, meshing, or other compact arrangements, the width 811 of the manipulator body (e.g., measured between opposing walls of the housing 803) can be kept to a minimum. This allows for a compact configuration in which vial holders are as close to each other as possible, yet still operate independently and without interfering with each other's movement. The compact arrangement of the pivot mechanism can further provide the ability to arrange multiple vial holders on the same manipulator body, thereby potentially reducing the total footprint of the pharmaceutical preparation system, as the vial manipulator can hold and move multiple vials in a relatively small and confined space.

[0117] In some embodiments, the distance between the pivot plates of opposing vial holders, measured across the manipulator body, is 15 cm, 10 cm, 5 cm, 4 cm, 3 cm, 2 cm, or an intermediate or shorter distance or less.

[0118] Figures 9A to 9B are cross-sectional views of a vial manipulator according to an embodiment of the subject matter of this disclosure, such as the one shown in Figures 7A to 7B.

[0119] As shown in the figure, each motor 901 can be connected to its associated vial holder, more specifically, to the pivot plate 905 of the vial holder by a shaft bearing 903 that transmits the rotation of the motor to the pivot motion of the pivot plate. The shaft bearing 903 extends from the motor inside the housing of the manipulator body to the outside of the housing where the pivot plate is located.

[0120] As further shown, the rotation mechanism of the manipulator body 907 is actuated by one or more actuators, such as a motor 909. The motor 909 is connected to a gear 911 such that the rotation of the gear by the motor rotates the manipulator body relative to the platform 913 (e.g., a table) of the pharmaceutical preparation system.

[0121] Figures 10A and 10B are schematic diagrams (Figure 10A) and (Figure 10B) of an arrangement comprising a vial manipulator and an operating module constituting a reconstitution / dilution module, according to one embodiment of the subject matter of this disclosure.

[0122] In some embodiments, a vial manipulator, such as one described herein, is used in conjunction with a reconstitution and / or dilution module that can acquire or receive a fluid from a fluid source (e.g., from an IV bag, syringe, or container) and introduce the fluid into a drug vial in a selected volume to dilute a concentrated liquid drug or reconstitute a dry powder drug by dissolving the powder in the fluid.

[0123] The fluid introduced by the module may include a diluent such as saline solution, water, or other suitable fluid.

[0124] The volume of fluid introduced into the vial can be controlled, based on the specific contents of the vial, for example, according to the drug's prescription label and / or other instructions, so as to reach a selected concentration or a selected total volume.

[0125] For example, a reconfiguration and / or dilution module as described herein is configured for use with a number of disposable (optionally, single-use) components such as IV bags, syringes, and connectors and / or adapters used with these components. Optionally, components may be used multiple times with the module; for example, a syringe may be used multiple times, for example, when acting as a piston to draw out and / or inject fluid.

[0126] As shown in this embodiment, the dilution and / or reconstitution module 1003 comprises the following: - For example, an IV bag holder 1007 configured to hold an IV bag 1009 (a bag not shown in Figure 10B) by having a support such as tongs, a hook, and / or other suitable support for maintaining the retention of the IV bag, - A syringe assembly manipulator 1011 is configured to hold and operate the syringe assembly 1013. In some embodiments, the syringe assembly manipulator is operable to move the syringe assembly as a whole, for example, to move the syringe axially toward or away from the vial manipulator. In some embodiments, the syringe assembly manipulator is configured to move the components of the syringe assembly independently, for example, to move the plunger of the syringe axially to draw out or inject fluid. - A selector 1015, such as a T-shaped stopcock, is positioned and configured to provide a switchable fluid connection to the IV bag of the syringe assembly (e.g., via tubing 1016, as shown in Figure 10B) or to the vial assembly 1017 held in the vial manipulator 1019. In some embodiments, one or more one-way valves (not shown) may be used, which are positioned to allow fluid to flow only from the IV bag into the syringe assembly and / or only from the syringe assembly to the vial assembly.

[0127] As shown in Figure 10B, the dilution and / or reconstitution module is positioned vertically above the vial manipulator so that the vial assembly, held by the vial manipulator holder 1020, can be aligned with the syringe assembly for fluid transfer, for example, for fluid injection into the vial.

[0128] The operation of the arrangement can be controlled by at least one controller 1021 configured to control multiple actuators 1023 of the vial manipulator and multiple actuators of the dilution and / or reconstitution module. In some embodiments, the controller communicates with one or more imaging devices 1025 used to verify, identify, and / or measure data. Non-limiting examples of data collected via the imaging devices may include the type and / or amount of fluid, the presence of powder particles in the vial after agitation, the presence of bubbles in the fluid, the volume of the fluid, and / or other data.

[0129] In an exemplary usage process, the controller commands the actuator of the vial holder to hold the vial assembly in a stable, upright, non-pivoting orientation. The controller commands the selector to fluidly communicate the syringe assembly with the IV bag and to draw a specified volume of diluent from the IV bag by controlled pulling of the syringe plunger (via the syringe assembly manipulator). The controller then commands the selector to position the syringe assembly fluidly communicating with the vial assembly and to inject a specified volume of diluent into the vial. The controller may then command the actuator of the vial holder to repeatedly pivot the vial assembly to agitate the filled vial and mix its contents. Optionally, the controller commands the rotation mechanism of the vial manipulator to change the position of the vial assembly by rotating the manipulator body around its axis. The rotation of the manipulator body may be performed, for example, before or after agitating the vial assembly.

[0130] In some embodiments, the filled vial remains held by a vial manipulator for the process of drawing the prepared drug from the vial, for example, as described below in Figures 11A and 11B.

[0131] Figures 11A and 11B are schematic diagrams (Figure 11A) and (Figure 11B) of an arrangement comprising a vial manipulator and an operating module constituting a fluid extraction module, according to one embodiment of the subject matter of this disclosure.

[0132] In some embodiments, a vial manipulator, such as the one described herein, is used with a fluid extraction module that can extract fluid from a vial, for example, extract a prepared drug from a vial, and optionally transfer the drug to an IV bag or other container for storage and / or administration to a patient.

[0133] The amount of medication drawn from the vial can be controlled as needed, for example, according to the patient's prescription or other instructions.

[0134] For example, a fluid extraction module as described herein is configured for use with a number of disposable (optionally, single-use) components such as IV bags, syringes, and connectors and / or adapters used with these components. Optionally, components may be used multiple times with the module; for example, a syringe may be used multiple times, for example, when acting as a piston to extract and / or inject fluid.

[0135] As shown in this embodiment, the fluid extraction module 1103 includes the following: - For example, an IV bag holder 1107 configured to hold one or more IV bags 1109 by having a support on which the bags can be placed. Note that, in addition to IV bags, containers may be used to receive prepared medications removed from vials. - A syringe assembly manipulator 1111 is configured to hold and operate the syringe assembly 1113. In some embodiments, the syringe assembly manipulator is operable to move the syringe assembly as a whole, for example, to move the syringe axially toward or away from the vial manipulator. In some embodiments, the syringe assembly manipulator is configured to move the components of the syringe assembly independently, for example, to move the plunger of the syringe axially to draw out or inject fluid.

[0136] As shown in Figure 11B, the fluid extraction module can be moved, for example, by sliding, to a position vertically below the vial manipulator 1122, thereby allowing the vial assembly 1124, held by the vial manipulator's holder, to be aligned with the syringe assembly of the fluid extraction module for fluid transfer, for example, for fluid extraction from the vial. In some embodiments, as shown, the syringe assembly is movable horizontally on the frame 1126, such as along the horizontal axis of the platform (table) 1129 or an axis parallel thereto.

[0137] The operation of the arrangement can be controlled by at least one controller 1121 configured to control multiple actuators 1123 of the vial manipulator and fluid extraction module. In some embodiments, the controller communicates with one or more imaging devices 1125 used to verify, identify, and / or measure data, for example, verifying or identifying the type and / or amount of drug in the vial, verifying and / or measuring the amount of drug drawn into the syringe by the module, verifying the position of the syringe assembly and / or vial assembly, and / or other data.

[0138] In an exemplary usage process, the controller instructs the vial holder actuator to hold the vial assembly stably and in an inverted, upside-down orientation. The controller then commands the syringe assembly manipulator to position the syringe assembly in fluid communication with the vial assembly. The controller then commands the syringe assembly manipulator to draw a specified volume of drug from the vial by controlled pulling of the syringe plunger.

[0139] Optionally, the controller instructs the vial manipulator's rotation mechanism to rotate the manipulator body around its axis to change the position of the vial assembly. The rotation of the manipulator body may be performed, for example, to position a new vial assembly in a location from which a drug can be drawn after fluid has been drawn from the previous vial assembly.

[0140] Optionally, the controller commands the syringe assembly manipulator to position the syringe assembly so that it is in fluid communication with the IV bag in order to inject the prepared drug into the bag. Optionally, positioning the syringe assembly to be in fluid communication with the IV bag is performed by moving (e.g., sliding) the syringe manipulator along the frame to a position aligned with the IV bag.

[0141] Figure 12 is a side view of another vial manipulator structure according to one embodiment of the subject matter of this disclosure.

[0142] In the illustrated example, two vial holders are connected to a pivotable bar 1207, with the vial holders facing in opposite directions. The frames 1209 of each holder are connected to the opposite end of the bar, so that the vial assemblies held by the holders are oriented in opposite directions relative to each other (one vial assembly is upright and the other is inverted). During use, the pivot of the bar around a pivot axis passing through pivot point 1211 inverts the vial assembly, causing the inverted vial assembly to become upright, and vice versa.

[0143] The bar 1207 can constitute the manipulator body itself, or it can be connected to a manipulator body configured to rotate relative to a platform (not shown) by a rotation mechanism, for example, as described herein. Rotation of the vial manipulator can change the position of the vial holder.

[0144] Figure 13 is a schematic diagram of syringe assembly and vial assembly components used in a pharmaceutical preparation system and interfaced with each other, according to embodiments of the subject matter of this disclosure.

[0145] The vial assembly 1301 includes a vial 1303, for example, a standard drug vial. Optionally, a vial adapter 1302 is connected to the top of the vial and can be gripped for transferring the vial. Optionally, a vial partition 1305 is configured as part of the vial adapter or mounted separately on the vial adapter to at least partially seal access to the vial.

[0146] Syringe assembly 1307 includes a syringe 1309, for example, a standard syringe. The syringe may be equipped with a needle 1311 or cannula suitable for transferring fluids and optionally suitable for penetrating partitions or other seals or structures to access containers such as vials. The needle may include a bevel on its distal portion.

[0147] Optionally, the syringe connector 1313 is connected to the syringe hub.

[0148] Optionally, the syringe septum 1315 may be configured as part of the connector or mounted separately on the connector.

[0149] During use, a fluid connection can be established between the syringe assembly and the vial assembly, and the syringe needle can optionally advance into and / or through the vial partition and / or into the vial itself. In some embodiments, the fluid connection may be established only after the vial partition and the syringe partition have come into contact with each other, and optionally, a reaction force exceeding a selected force threshold is applied to each other.

[0150] Figure 14A is an isometric view of a vial manipulator according to one embodiment of the subject matter of this disclosure.

[0151] The vial manipulator 1401 in this example comprises a manipulator body 1403 mounted on a disk-shaped platform 1405, the platform functioning to rotate the manipulator body around its long axis. Two vial holders 1407 are connected to opposing outer surfaces of the housing of the manipulator body. Each vial holder includes a pivot plate 1409 pivotably connected to the body, a rectangular frame 1411 formed as a continuous extension of the top of the pivot plate, and a pair of clamp arms 1413 extending outward from the frame, facing away from the manipulator body, for receiving a vial assembly. As shown in Figure 14B, an enlarged top view of the vial holder, the clamp arms are configured to snap onto the vial assembly when the vial assembly is pushed inward toward the pivot plate. (In this example, the clamp arms press and hold a vial adapter 1415 mounted on top of the vial).

[0152] The clamp arms are positioned apart from each other to allow insertion of the vial assembly, and are then configured to elastically spring back toward each other to clamp onto the vial assembly. This is made possible in this example by a spring-based mechanism 1417 housed within the frame 1411. A spring 1419 (such as a coil spring) extends at least partially across the two clamp arms, between the ends of the clamp arms connected to the frame. The spring is configured to extend longitudinally when the clamp arms are pushed apart from each other (during insertion of the vial assembly) and to return to its compressed state to pull the clamp arms toward each other so that the vial assembly is gripped between the clamp arms.

[0153] It should be noted that, in addition to or instead of the spring, other elastic members (e.g., elastic bands) can be used to pull the clamp arms toward each other.

[0154] Figure 15 shows a vial manipulator for holding a vial assembly in various orientations according to one embodiment of the subject matter of the present disclosure. In the example of Figure 15, four vial holders 1501, 1502, 1503, and 1504 are connected to a manipulator body 1505, oriented 90 degrees apart from each other. In the illustrated example, the manipulator body 1505 has a polygonal horizontal cross-sectional shape with four walls, and each of the vial holders extends outward from the respective wall of the manipulator body 1505.

[0155] The two vial assemblies 1511 and 1513, held in holders 1501 and 1503 respectively, are shown in their initial upright orientation, while the vial assemblies 1512 and 1514, held in holders 1502 and 1504 respectively, are shown in their inverted orientation (for example, when one or more of the vial assemblies are held stably in a pivoted orientation, such as during agitation of the vial assemblies or for the purpose of fluid transfer). Although vial assembly 1512 is shown connected to a syringe, it should be understood herein that the vial assembly does not need to be connected to a syringe. In fact, in some examples, the vial manipulator can also hold and pivot the vial assembly together with the syringe.

[0156] Each corresponding pivot plate (not shown) of the vial holder is located within the manipulator body 1505, and the corresponding frame extends outward from there. It should be understood that the descriptions of vial holder pivoting and manipulator body rotation provided above in this specification for various examples also apply to vial holders 1501, 1502, 1503, and 1504, as well as manipulator body 1505, with necessary modifications.

Claims

1. A vial manipulator for use in a robotic pharmaceutical preparation system, wherein the vial manipulator is The manipulator body defines the main axis, A first vial holder is pivotably coupled to the manipulator body and configured to receive and hold the vial assembly, A first pivot mechanism for pivoting the first vial holder around a first axis extending outward from the main body in a first direction, A second vial holder is pivotably coupled to the manipulator body and configured to receive and hold the vial assembly, A second pivot mechanism for pivoting the second vial holder around a second axis extending outward from the main body in a second direction different from the first direction, A vial manipulator equipped with the following features.

2. The vial manipulator according to claim 1, wherein the first direction and the second direction define an angle of at least 90 degrees between them.

3. The vial manipulator according to claim 1 or 2, wherein the first direction and the second direction define an angle of 180 degrees between them and are opposite to each other such that the first axis and the second axis are directly aligned.

4. The vial manipulator according to any one of claims 1 to 3, wherein the first axis and the second axis are perpendicular to the main axis.

5. The vial manipulator according to any one of claims 1 to 4, wherein each of the first pivot mechanism and the second pivot mechanism is provided with a pivot mounting portion for the respective vial holder to the manipulator body, and the respective first shaft and second shaft pass through the pivot mounting portion.

6. Each of the first vial holder and the second vial holder is, In the pivot mounting section, a pivot plate is pivotably connected to the wall of the manipulator body, A frame connected to and extending from the pivot plate, wherein the frame is configured to receive and hold the vial assembly, The vial manipulator according to claim 5, wherein the pivot of the pivot plate is configured to carry the frame together, thereby changing the orientation of the vial assembly held by the frame.

7. The vial manipulator according to claim 6, wherein the frame is fixedly connected to the pivot plate.

8. The vial manipulator according to claim 6 or 7, wherein the frame is at least partially open and comprises a set of clamping arms extending into the frame to clamp at least the portion of the vial assembly.

9. The vial manipulator according to claim 8, wherein at least a portion of the vial assembly comprises the top of the vial or an adapter attached to the top of the vial, and the clamp arm is molded to snap into the at least portion of the vial assembly.

10. The vial manipulator according to any one of claims 1 to 9, further comprising a rotation mechanism configured to rotate the manipulator body around the main shaft.

11. The vial manipulator according to claim 10, wherein the manipulator body is mounted on a platform and is rotatable relative to the platform by the rotation mechanism.

12. The vial manipulator according to any one of claims 1 to 11, wherein the pivoting of the vial holder is configured to change the orientation of the vial assembly from an initial orientation in which the vial assembly is upright.

13. The vial manipulator according to claim 12, wherein the vial assemblies held by each of the vial holders are pivotably movable on the respective first and second planes, each of which intersects the first and second axes and is perpendicular to the first and second axes, each of which intersects the first and second axes and is perpendicular to the first and second axes, each of which extends through the first and second planes, each of which is parallel to the principal axis, and in the initial orientation of the vial assemblies held by the vial holders, the longitudinal axis of each vial assembly is aligned with the third and fourth axes, respectively.

14. The vial manipulator according to any one of claims 1 to 13, wherein each of the first pivot mechanism and the second pivot mechanism comprises an actuator for pivotably moving the vial holder.

15. The vial manipulator according to claim 14, wherein the actuator is completely housed within the housing of the manipulator body.

16. The vial manipulator according to claim 15, wherein the actuators of the first vial holder and the second vial holder are arranged side by side symmetrically within the housing.

17. The vial manipulator according to any one of claims 14 to 16, wherein the actuator is controlled by a controller.

18. The vial manipulator according to any one of claims 14 to 17, wherein each actuator is equipped with a motor, and each vial holder is connected to the motor via a shaft bearing.

19. The aforementioned controller operates in the following modes, namely: a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly held by the vial holder, b. An orientation setting mode that pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in the selected orientation so as to enable the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, The vial manipulator according to claim 17, configured to independently select and operate the first vial holder and the second vial holder according to one or more of the following:

20. The vial manipulator according to claim 19, wherein the controller is configured to operate the first vial holder and the second vial holder according to all operating modes (a) to (c).

21. The vial manipulator according to claim 19, as dependent on claim 13, wherein the controller operates the vial holder in accordance with the stirring mode (a) by repeatedly pivoting the vial holder such that the longitudinal axis of the vial assembly held by the vial holder defines a variable angle less than 90 degrees with respect to the opposite side of the third axis or the fourth axis, respectively, in order to cause the vial assembly to swing in a pendulum-like motion.

22. The vial manipulator according to claim 19, as dependent on claim 13, wherein the controller operates the vial holder by pivoting the vial holder such that the longitudinal axis of the vial assembly held by the vial holder defines a fixed angle of 0 to 180 degrees with respect to the third axis or the fourth axis, respectively, according to the orientation setting mode (b).

23. The vial manipulator according to claim 22, wherein the pivoting of the vial assembly in the orientation setting mode (b) is configured to invert the vial assembly at an angle of 180 degrees.

24. The vial manipulator according to claim 17, as dependent on claim 10, wherein the controller is further configured to control the rotation mechanism to set the rotational positions of the first vial holder and the second vial holder.

25. The vial manipulator according to claim 17, wherein the vial manipulator constitutes part of a robotic pharmaceutical preparation system, the robotic pharmaceutical preparation system further comprises an operating module configured to interface with a vial assembly held by the vial manipulator, and the controller further configured to control the operating module.

26. The vial manipulator according to claim 25, wherein the operating module is a reconfiguration / dilution module comprising a fluid insertion component, and the vial manipulator is spatially positioned relative to the fluid insertion component such that each vial assembly held by one of the first vial holder and the second vial holder is positioned below the fluid insertion component.

27. The vial manipulator according to claim 26, as dependent on claim 19, wherein the controller is configured to operate the vial holder according to the fluid communication mode (c) in order to introduce fluid into the vial assembly via the fluid insertion component.

28. The vial manipulator according to claim 25, wherein the operating module comprises a fluid extraction module having a fluid extraction component, and the vial manipulator is spatially positioned relative to the fluid extraction component such that a vial assembly held by one of the first vial holder and the second vial holder is positioned above the fluid extraction component.

29. The vial manipulator according to claim 28, as dependent on claim 19, wherein the controller is configured to operate the vial holder according to the fluid communication mode (c) in order to draw fluid through the fluid extraction component.

30. The vial manipulator according to claim 25, wherein the operating module comprises an articulated arm, and the vial manipulator is spatially positioned such that only one of the first vial holder and the second vial holder is within the reach of the arm, and the other vial holder is outside the reach of the arm.

31. A method for controlling a vial manipulator in a robotic pharmaceutical preparation system, wherein the vial manipulator comprises a manipulator body and a first vial holder and a second vial holder pivotably connected to the manipulator body, and the method is as follows: The first vial holder is selectively pivoted around a first axis that extends outward in a first direction from the manipulator body, The second vial holder is selectively pivoted in a second direction different from the first direction, around a second axis extending outward from the manipulator body, Methods that include...

32. The method according to claim 31, wherein the first direction and the second direction define an angle of at least 90 degrees between them.

33. The method according to claim 31 or 32, wherein the first direction and the second direction define an angle of 180 degrees between them and are opposite to each other such that the first axis and the second axis are directly aligned.

34. The method according to any one of claims 31 to 33, wherein the first axis and the second axis are perpendicular to the principal axis.

35. The method according to any one of claims 31 to 34, wherein each of the first vial holder and the second vial holder comprises a pivot plate pivotably connected to the wall of the manipulator body and a frame connected to and extending from the pivot plate, the frame being configured to receive and hold the vial assembly, and the selective pivoting includes pivoting the pivot plate while carrying the frame, thereby changing the orientation of the vial assembly held by the frame.

36. A vial manipulator for use in a robotic pharmaceutical preparation system, wherein the vial manipulator is The manipulator body defines the main axis, A first vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A rotation mechanism configured to rotate the manipulator body around the main shaft, A vial manipulator equipped with the following features.

37. The vial manipulator according to claim 36, further comprising: a first pivot mechanism for pivoting the first vial holder around a first axis extending outward from the main body in a first direction; and a second pivot mechanism for pivoting the second vial holder around a second axis extending outward from the main body in a second direction.

38. The vial manipulator according to claim 37, wherein the first axis and the second axis are perpendicular to the main axis.

39. Each of the first vial holder and the second vial holder is, A pivot plate is pivotably connected to the side wall of the manipulator body, A frame connected to and extending from the pivot plate, wherein the frame is configured to receive and hold the vial assembly, The vial manipulator according to any one of claims 36 to 38, wherein the pivot of the pivot plate moves the frame to at least partially change the orientation of the vial assembly held by the frame.

40. A vial manipulator according to any one of claims 36 to 39, wherein the vial assemblies held by each of the vial holders are movable on a first plane and a second plane, the first plane and the second plane intersect with the first axis or the second axis, respectively, and both a third axis and a fourth axis parallel to the principal axis pass through and extend therethrough, the third axis and the fourth axis each being perpendicular to the first axis and the second axis, respectively, and in the initial orientation of the vial assemblies held by each of the vial holders, the long axis of each vial assembly is aligned with the third axis and the fourth axis, respectively.

41. The vial manipulator according to any one of claims 36 to 40, wherein each of the first pivot mechanism and the second pivot mechanism comprises an actuator for pivoting the vial holder.

42. The vial manipulator according to claim 41, wherein the actuator is controlled by a controller.

43. The aforementioned controller operates in the following modes, namely: a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly held by the vial holder, b. An orientation setting mode that pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in the selected orientation so as to enable the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, The vial manipulator according to claim 42, configured to independently select and operate the first vial holder and the second vial holder according to one or more of the following:

44. The vial manipulator according to claim 42, wherein the controller is further configured to control the rotation mechanism to set the rotational positions of the first vial holder and the second vial holder.

45. A method for controlling a vial manipulator in a robotic pharmaceutical preparation system, wherein the vial manipulator comprises a manipulator body having a main shaft, and a first vial holder and a second vial holder pivotably connected to the manipulator body, and the method is as follows: The first vial holder and the second vial holder are designed to accept the corresponding first vial assembly and the second vial assembly, Selectively pivoting at least one of the first vial holder and the second vial holder, The manipulator body is rotated around its main axis to change the positions of the first vial holder and the second vial holder, Methods that include...

46. The method according to claim 45, wherein selective pivoting includes repeatedly pivoting the first vial holder while keeping the second vial holder stationary, thereby agitating the vial assembly held by the first vial holder.

47. The method according to claim 46, further comprising inserting fluid into the second vial assembly held by the second vial holder before rotating the manipulator body.

48. The method according to claim 45, wherein selective pivoting includes pivoting the first vial holder 180 degrees from its initial orientation to hold the first vial assembly in an inverted orientation.

49. The method according to claim 48, further comprising drawing fluid from the first vial assembly held by the first vial holder before rotating the manipulator body.

50. A robotic pharmaceutical preparation system, A vial manipulator, The manipulator body defines the main axis, A first vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the manipulator body and configured to receive and maintain the vial assembly, A vial manipulator comprising a rotation mechanism configured to rotate the manipulator body around the main shaft, A robotic pharmaceutical preparation system comprising: an operating module having an operating region and configured to interface with a vial assembly in the operating region, wherein the rotation mechanism is configured to rotate the manipulator body to bring one of the first vial holder and the second vial holder into the operating region and to move the other of the first vial holder and the second vial holder out of the operating region.

51. The system according to claim 50, wherein the operating module comprises a fluid insertion component and / or a fluid extraction component.

52. The system according to claim 51, wherein the fluid insertion component and / or the fluid extraction component comprises a syringe.

53. The system according to claim 50, wherein the operating module comprises an articulated arm having a distal end configured to engage with a vial assembly.

54. The system according to claim 53, wherein the operating region includes a region within the reach of the distal end of the arm.

55. A robotic pharmaceutical preparation system, A vial manipulator, The manipulator body and A first vial holder configured to receive and maintain a vial assembly, wherein the first vial holder is pivotably coupled to the manipulator body, A vial manipulator comprising: a first pivot mechanism configured to pivot the first vial holder; The system comprises an operating module spatially positioned relative to the first vial holder and configured to hold a fluid communication component for interfacing with the vial assembly, The first pivot mechanism pivots the first vial holder to the following state, namely, The vial assembly held by the first vial holder is in a first state in which it is oriented upright so that fluid communication with the fluid communication component is established for the insertion of fluid by the fluid communication component, The vial assembly held by the first vial holder is in a second state in which it is in an inverted orientation in which fluid communication with the fluid communication component is established in order to draw fluid through the fluid communication component, A robotic pharmaceutical preparation system configured to take

56. The system according to claim 55, wherein the fluid communication component includes a syringe.

57. The system includes a controller, and the controller has the following operating modes, namely, (a) A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial assembly, (b) An orientation setting mode that pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, (c) A fluid communication mode in which the vial holder is stably held in either the first state or the second state, The system according to claim 55 or 56, configured to select and operate the first vial holder according to one or more of the following.

58. A second vial holder configured to receive and maintain a vial assembly, wherein the second vial holder is pivotably coupled to the manipulator body, The system according to any one of claims 55 to 57, further comprising a second pivoting mechanism configured to pivot the second vial holder.

59. The system according to claim 58, further comprising a rotation mechanism configured to rotate the manipulator body around the main shaft of the manipulator body, thereby exchanging the positions of the first vial holder and the second vial holder.

60. A vial manipulator for use in a robotic pharmaceutical preparation system, wherein the vial manipulator is The manipulator body defines the main axis, A first vial holder is pivotably coupled to a first surface of the manipulator body and configured to receive and maintain the vial assembly, A second vial holder is pivotably coupled to the second surface of the manipulator body and configured to receive and maintain the vial assembly, A controller, wherein the controller has the following operating modes, namely, a. A stirring mode in which the vial holder is repeatedly pivoted in order to mix the contents of the vial held by the vial holder, b. An orientation setting mode that pivots the vial holder to set a temporarily fixed orientation of the vial assembly held by the vial holder, c. A fluid communication mode in which the vial holder is stably held in the selected orientation so as to enable the insertion of fluid into or withdrawal of fluid from the vial assembly held by the vial holder, A controller configured to independently select and operate the first vial holder and the second vial holder according to one or more of the following: A vial manipulator equipped with the following features.

61. The vial manipulator according to claim 60, which can sequentially execute two or more of the operating modes without removing the vial assembly from the vial holder.

62. The vial manipulator according to claim 60 or 61, further comprising a rotation mechanism configured to rotate the manipulator body around the main shaft, wherein the controller is further configured to control the rotation mechanism and synchronize the rotation with the operating mode.

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