Vial manipulator for use in robotic drug preparation system

Abstract

A vial manipulator for use in a robotic drug preparation system, the vial manipulator comprising: a manipulator body defining a main axis; a first vial holder pivotally coupled to the manipulator body and configured to receive and hold a vial assembly; a first pivoting mechanism for pivoting the first vial holder about a first axis, the first axis extending outwardly from the body in a first direction; a second vial holder pivotally coupled to the manipulator body and configured to receive and hold a vial assembly; and a second pivoting mechanism for pivoting the second vial holder about a second axis, the second axis extending outwardly from the body in a second direction different from the first direction. The vial manipulator may also include a rotation mechanism configured to rotate the manipulator body about the main axis.

Description

Technical Field

[0001] The present application relates to robotic medication preparation systems, and more particularly to the manipulation of containers (eg, vials) within robotic medication preparation systems. Background Art

[0002] US9804586 discloses "a robot control method is disclosed, the method comprising the following steps: providing a user interface for introducing data representing a drug to be subjected to a reconstitution process; accessing an internal database to output a list of basic movements P1, P2...Pi...Pn to be used in the reconstitution process for the selected drug; operating the robot to sequentially perform the basic movements and move the container according to the instructions of the basic movements; measuring the physical position of the container in space and its dynamic parameters during the movement of the container by the robot to generate a list of recorded data; comparing the measured position in space and the dynamic parameters with corresponding basic movements of the basic movements to select a list of appropriate basic movements when a sufficient level of proximity is achieved; combining the selected appropriate basic movements to generate instructions for the robot to allow complex movements, the complex movements including simple movements; and shaking the container using the robot according to the complex movements."

[0003] US11246803 discloses that "a vial press wheel is provided, which is configured to be attached to a vial containing a medication. The vial press wheel includes various features to facilitate uniform control of vials of various sizes in an automatic compounder system. The vial press wheel features may include a vial groove for receiving a vial of a specific size and securing the vial in the vial groove. The features may also include a cylindrical center portion, a vertical extension extending from the top of the cylindrical center portion, a gear extending from the cylindrical center portion, and a sealing member disposed in the cylindrical center portion. The vial press wheel may include a cylindrical protrusion configured to press against the septum of the vial to form a seal between the vial press wheel and the vial. The sealing member may be configured to receive a needle of the compounder system, the needle passing through the sealing member to allow access to the vial." Summary of the Invention

[0004] A robotic drug preparation system may include an automated or partially automated system including at least one manipulator controlled at least in part by a controller, and may also include one or more drive assemblies for generating movement of the manipulator, as further described below.

[0005] The robotic medication preparation system is operable to perform any activity related to the preparation of a medication, such as a medication prescribed for administration to a patient, including compounding, diluting, reconstituting, transferring, filling, pumping, agitating, and / or other processes associated with medication preparation.

[0006] In some examples, the robotic medication preparation system can be configured to receive a medication vial; dilute or reconstitute the medication in the vial as needed; and then obtain a defined amount of medication by aspirating from the vial. Optionally, the medication is then prepared for administration to a patient, for example, by transferring the medication into a syringe and / or an intravenous (IV) bag.

[0007] The robotic medication preparation system can include one or more fluid transfer modules, such as a fluid aspiration module, a dilution module, and / or other fluid transfer modules. The components of the medication preparation system can be arranged on a platform (e.g., a table, an optionally recessed table, the inner surface of a cover), wherein at least some of the components are capable of moving relative to each other and / or relative to the platform. Movement of the components can typically occur along the length and / or width dimension of the platform and optionally relative to the platform, such as above the platform, below the platform, or across the thickness of the platform, for example, via a recess formed in the platform or vertically across an edge of the platform.

[0008] This medicine preparation system can be deployed for preparing any type of medicine, be included in the dangerous medicine and non-dangerous medicine prepared in closed system.In the closed fluid transfer system that is deployed for preparing dangerous medicine, measures are taken to prevent fluid and / or smoke from leaking dangerously from container (such as syringe, bottle, IV bag etc.).In order to ensure alignment and provide firm connection during fluid transfer, connector or adapter can be used together with container and / or be used conventionally at the fluid transfer interface of system.It should be understood in this article that, for the purpose of this specification, if connector or adapter are used together with container, then this combination is referred to as container assembly in this article.For example, as described herein, bottle assembly should be understood as bottle and the bottle adapter / connector attached thereto in this article.According to some examples, manipulator can be constructed to receive, hold and manipulate container (for example, bottle) and container assembly (for example, the bottle with the bottle adapter attached thereto) separately.

[0009] The focus of the present application is a vial manipulator for use in a robotic drug preparation system. The manipulator is capable of receiving and holding a plurality of containers, such as vials. The manipulator can be configured to selectively manipulate each of the vials so as to pivot the vial to a selected orientation; and / or agitate (e.g., swing) the vial to mix its contents; and / or optionally stabilize the vial in a selected orientation, for example, so as to enable a fluid to be inserted into or extracted from the vial. According to some embodiments, the vial manipulator is further configured to rotate relative to a platform on which the vial manipulator is mounted (e.g., a workbench of a drug preparation system) so that the positions of the plurality of vials held by the manipulator are changed by the rotation.

[0010] According to a first aspect, there is provided a vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising:

[0011] a manipulator body defining a primary axis;

[0012] a first vial holder pivotably coupled to the manipulator body and configured to receive and hold a vial assembly;

[0013] a first pivot mechanism for pivoting the first vial holder about a first axis extending outwardly from the body in a first direction; and

[0014] a second vial holder pivotably coupled to the manipulator body and configured to receive and hold a vial assembly;

[0015] A second pivot mechanism for pivoting the second vial holder about a second axis extending outwardly from the body in a second direction different from the first direction.

[0016] For the purposes of this specification, the direction in which the pivot axis of a vial holder extends should be understood as along a vector extending from the manipulator body toward the corresponding vial holder. For example, a first direction in which a first pivot axis of a first vial holder extends outward from the body should be understood as along a vector extending from the body toward the first vial holder. Similarly, a second direction in which a second pivot axis of a second vial holder extends outward from the body should be understood as along a vector extending from the body toward the second vial holder. Similarly, any direction in which the pivot axis of a particular vial holder extends outward from the body should be understood as along a vector extending from the body toward the particular vial holder.

[0017] The vial manipulator can provide for selective manipulation of each of the vial assemblies held by the vial holders, wherein each of the holders is operable via its associated pivot mechanism. That is, each pivot mechanism can be configured to pivot or stabilize another vial holder associated with the pivot mechanism, independent of the vial holder's current state. Examples of operational states that can be provided by the described device include repeatedly pivoting (agitating) one vial assembly while stabilizing another vial assembly in any orientation; agitating two vial assemblies independently of each other in the same or different manners; stabilizing two vial assemblies independently of each other in any orientation; and pivoting each of the vials to a selected orientation defined by each vial, such as holding one vial upright while another vial is flipped over.

[0018] It should be noted that the vial manipulator can include more than two vial holders, such as 3, 4, 5, 6, 8, 10, or intermediate, larger, or smaller numbers of vial holders. The vial holders can be symmetrically arranged relative to the manipulator body, for example, defining equal angles between them (e.g., 180 degrees between the vial holders when two vial holders are used, 90 degrees between the vial holders when four vial holders are used, etc.). Alternatively, the vial holders can be arranged in other ways relative to the manipulator body, for example, asymmetrically. The vial holders can be independently operated via their associated respective pivot mechanisms, as described above for the two vial holders.

[0019] Returning to the example of two vial holders, in some embodiments, the first direction and the second direction define an angle of at least 90 degrees between them. Alternatively, the first direction and the second direction define an angle of 180 degrees between them and are directly opposite to each other, so that the first axis and the second axis are directly aligned. In this arrangement, the vial holders may face away from each other. In the example of a manipulator body with a rounded cross-sectional profile, the vial holders may be diametrically opposed to each other. In some embodiments, where the manipulator body is shaped to define multiple outer surfaces, each vial holder may extend from a different surface or face of the manipulator body (i.e., the housing of the manipulator body). Alternatively, the surface may be a flat surface.

[0020] In some embodiments, the first axis and the second axis about which the first and second vial holders can pivot can be perpendicular to the main axis. Each of the first and second pivot mechanisms can include a pivot attachment of the respective vial holder to the manipulator body, wherein each of the first and second axes passes through the respective pivot attachments.

[0021] In some embodiments, the vial manipulator may further include a rotation / rotation mechanism configured to rotate the manipulator body about the main axis. The manipulator body may be mounted on a platform and may be rotated relative to the platform by the rotation mechanism. Rotation of the manipulator body displaces the vial holders, potentially interchanging their positions or otherwise displacing each of the vial holders. It should be understood herein that the terms "rotation" and "rotation" with respect to movement of the manipulator body about the main axis have been used interchangeably. In other words, it should be understood herein that rotating the manipulator body about the main axis by the rotation mechanism includes rotating the manipulator body about the main axis, and therefore a rotation mechanism is also referred to as a rotation mechanism.

[0022] For example, a vial manipulator as described herein, configured to selectively pivot each of the vial assemblies held by the manipulator and to rotate about the primary axis of the manipulator body, can reduce or prevent the need to move the vial between different stations or manipulators, which are optionally remote from one another, because multiple processes can be performed with the vial held by the same vial holder, the position of which can be changed simply by rotating the manipulator body. This arrangement can reduce or prevent the need to pick up the vial and, for example, transfer the vial to another remote manipulator or station for further processing.

[0023] When a vial (or vial assembly) is held at a vial manipulator, such as that described herein, one or more of the following processes can be performed without the need to lift and transfer the vial: holding the vial holder steady to hold the vial in a selected orientation to dilute / reconstitute the contents of the vial, pivoting the vial holder to agitate the vial (e.g., by repeatedly pivoting the vial holder), holding the vial holder steady to hold the vial in a selected orientation to aspirate fluid from the vial, etc. Reducing the need for multiple stations or manipulators can contribute to a simpler, more compact system design, potentially with a smaller footprint. Furthermore, performing multiple processes while the vial is still held by the same vial holder can speed up preparation time and provide a higher preparation rate.

[0024] Referring now to the vial holder structure, in some embodiments, each of the first vial holder and the second vial holder may include:

[0025] a pivot plate pivotably connected to a wall of the manipulator body at the pivot attachment;

[0026] a frame connected to and extending from the pivot plate, the frame being configured to receive and retain the vial assembly;

[0027] The pivoting of the pivot plate is configured to drive the frame, thereby changing the orientation of the vial assembly held by the frame.

[0028] Optionally, the frame may be fixedly connected to the pivot plate. Optionally, the frame may be at least partially open and include a set of gripping arms extending within the frame for gripping onto at least a portion of the vial assembly.

[0029] In some examples, the frame can be directly connected to the body of the manipulator without the pivot plate, thereby forming the 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.

[0030] The at least one portion of the vial assembly gripped by the gripping arms may comprise a top portion of a vial, or an adapter mounted / attached to a top portion of a vial, wherein the gripping arms are configured to snap fit onto the at least one portion of the vial assembly. The gripping arms may be resilient and thus configured to retain vials and / or vial adapters of varying shapes and / or sizes (e.g., having varying diameters).

[0031] In some embodiments, the pivoting of the vial holder changes the orientation of the vial assembly from an initial orientation in which the vial assembly is upright. In one example, the vial assembly can be pivoted to an overturned orientation, and / or any non-vertical orientation.

[0032] In some embodiments, the vial assembly held by any or each of the vial holders is pivotally movable in respective first and second planes, each of the first and second planes intersecting and perpendicular to the first and second axes, respectively, and with respective third and fourth axes, each parallel to the primary axis, extending through the first and second planes; whereby in the initial orientation of the vial assembly held by the vial holder, the longitudinal axis of the respective vial assembly is aligned with the third and fourth axes, respectively.

[0033] In some configurations, the pivot mechanism can 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 relative to the third axis. Alternatively, the pivot mechanism can be configured to pivot the vial holder to orient the vial assembly only to 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 an intermediate, greater, or lesser number of angles and / or an intermediate, greater, or lesser range of angles.

[0034] In some embodiments, each of the first pivot mechanism and the second pivot mechanism includes an actuator for pivoting the vial holder. Alternatively, in some embodiments, a single actuator can be configured to drive both pivot mechanisms. In examples with more than two vial holders and corresponding pivot mechanisms, each pivot mechanism can include a respective actuator for pivoting the corresponding vial holder. In examples with more than two vial holders and corresponding pivot mechanisms, all or some of the pivot mechanisms can include a single, shared actuator for pivoting the corresponding vial holder.

[0035] The actuator of the pivot mechanism may be completely contained within the housing of the manipulator body. Alternatively, the actuator may be only partially contained within the housing. Alternatively, the actuator may be external to the housing. Note that more than one actuator may be used to drive each of the pivot mechanisms.

[0036] In some embodiments, the two actuators of the first vial holder and the second vial holder are symmetrically arranged side by side within the manipulator body housing.

[0037] The actuator may include a motor, and the corresponding vial holder driven by the actuator may be connected to the motor via a shaft bearing. Alternatively, the motor may be a servo motor. For example, by presetting an encoder of the servo motor, the vial holder may be pivoted to a selected angle.

[0038] In some embodiments, the actuator may be controlled by a controller. The controller may be 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 operating modes:

[0039] a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial held by the vial holder;

[0040] b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; and

[0041] c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

[0042] When the controller controls the actuator according to the agitation pattern, the controller may repeatedly pivot the vial holder so that the long axis of the vial assembly held by the vial holder defines a varying angle of less than 90 degrees relative to opposite sides of the third axis or the fourth axis, respectively, for causing the vial assembly to oscillate, for example, in a pendulum-like motion or a rotational movement.

[0043] When the controller controls the actuator according to the orientation setting mode, the controller may 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 between 0 and 180 degrees relative to the third axis. In one example, at an angle of 180 degrees, the vial assembly held by the vial holder is flipped over.

[0044] In some embodiments, the controller can also be configured to control the rotation mechanism to set the rotational position of the first vial holder and the second vial holder. In an example where the first vial holder and the second vial holder are opposite each other, rotating the manipulator body 180 degrees can interchange the positions of the first and second holders. Generally, the manipulator body can rotate around the main axis by any selected angle, such as 30 degrees, 60 degrees, 90 degrees, 270 degrees, 320 degrees, or intermediate, greater, or

[0045] Optionally, the rotation of the manipulator body is according to preset intervals, such as 90 degree intervals, 60 degree intervals, 30 degree intervals, or intermediate, larger, or smaller intervals. Optionally, the preset intervals are defined by the number and / or arrangement of the vial holders on the manipulator body.

[0046] The vial manipulator may form part of a robotic medication preparation system that also includes a handling module configured to interface with a vial assembly held by the vial manipulator.

[0047] In some cases, the operating module can be a reconstitution / dilution module, and the vial manipulator can be spatially arranged relative to a fluid insertion component of the reconstitution / dilution module such that a vial assembly held by one of the first vial holder and the second vial holder is aligned below the fluid insertion component. In this arrangement, the controller can be configured to operate the vial holder according to the fluid communication mode during insertion of fluid into the vial assembly via the fluid insertion component.

[0048] Similarly, the operating module can be a fluid aspiration module, and the vial manipulator can be spatially arranged relative to the fluid aspiration component of the module such that a vial assembly held by one of the first vial holder and the second vial holder is aligned above the fluid aspiration component. In this arrangement, the controller can be configured to operate the vial holder according to the fluid communication mode during aspiration of fluid through the fluid aspiration component.

[0049] In another example, the manipulation module can be an articulated arm, and the vial manipulator can be spatially positioned so that only one of the first vial holder and the second vial holder is positioned within the reach of the arm, while the other vial holder is outside the reach. In this arrangement, rotating the vial manipulator can interchange the vial holder positions, placing the vial holder that is outside the reach within the reach of the arm and moving the vial holder that is originally within the reach out of the reach.

[0050] In some cases, multiple manipulation modules (such as a reconstitution / dilution module, a fluid aspiration module, an articulatable arm, etc.) may be configured along with the vial manipulator as part of the same robotic drug preparation system.

[0051] According to a second aspect, there is provided a method of controlling a vial manipulator of a robotic drug preparation system, the vial manipulator comprising a manipulator body and first and second vial holders pivotably connected to the manipulator body, the method comprising:

[0052] selectively pivoting the first vial holder about a first axis extending outwardly from the manipulator body in a first direction; and

[0053] The second vial holder is selectively pivoted about a second axis extending outwardly from the manipulator body in a second direction different from the first direction.

[0054] According to a third aspect, there is provided a vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising:

[0055] a manipulator body defining a primary axis;

[0056] a first vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly;

[0057] a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; and

[0058] A rotation mechanism is configured to rotate the manipulator body about the main axis.

[0059] According to a fourth aspect, there is provided a method of controlling a vial manipulator of a robotic drug preparation system, the vial manipulator comprising a manipulator body having a main axis and first and second vial holders pivotably connected to the manipulator body, the method comprising:

[0060] receiving corresponding first and second vial assemblies at the first and second vial holders;

[0061] selectively pivoting at least one of the first vial holder and the second vial holder; and

[0062] The manipulator body is rotated about its primary axis to change the position of the first vial holder and the second vial holder.

[0063] The selective pivoting of the vial holders may include repeatedly pivoting the first vial holder to agitate the vial assembly held by the first vial holder while holding the second vial holder stationary. Optionally, prior to rotating the manipulator body, fluid is inserted into the second vial assembly held by the second vial holder.

[0064] The selective pivoting of these vial holders may comprise pivoting the first vial holder 180 degrees from an initial orientation to maintain the first vial assembly in an inverted orientation. Optionally, before rotating the manipulator body, fluid is extracted from the first vial assembly maintained by the first vial holder.

[0065] According to a fifth aspect, a robotic drug preparation system is provided, the robotic drug preparation system comprising:

[0066] A vial manipulator, the vial manipulator comprising:

[0067] a manipulator body defining a primary axis;

[0068] a first vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly;

[0069] a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; and

[0070] a rotation mechanism configured to rotate the manipulator body about the main axis; and

[0071] an operating module having an operating area and configured to dock with a vial assembly at the operating area; and a rotation mechanism configured to rotate the manipulator body to move 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.

[0072] In some cases, the operation module includes a fluid insertion component and / or a fluid aspiration component. Optionally, the fluid insertion component and / or the fluid aspiration component includes a syringe.

[0073] In some cases, the operation module includes an articulated arm having a distal end configured to engage a vial assembly. In this case, the operation area may include an area within the reach of the distal end of the arm. Optionally, the arm may only engage (optionally, lift and / or transfer) the vial assembly currently within its reach (within the operation area), and may not access another vial assembly outside the operation area. This arrangement can improve system safety, for example, by reducing or preventing undesired contact (or other engagement) between the arm and a vial assembly that is not currently intended to be transferred by the arm (e.g., a vial assembly currently being agitated, or a vial assembly being filled with fluid or having fluid withdrawn from it).

[0074] According to a sixth aspect, a robotic drug preparation system is provided, the robotic drug preparation system comprising:

[0075] A vial manipulator, the vial manipulator comprising:

[0076] Manipulator body;

[0077] a first vial holder configured to receive and maintain retention of a vial assembly, the first vial holder being pivotably coupled to the manipulator body; and

[0078] a first pivot mechanism configured to pivot the first vial holder;

[0079] an operating module spatially arranged relative to the first vial holder and configured to hold a fluid communication component for interfacing with the vial assembly;

[0080] wherein the first pivot mechanism is configured to pivot the first vial holder to assume the following state:

[0081] a first state in which the vial assembly held by the first vial holder is in an upright orientation in which fluid communication is established with the fluid communication component for inserting a fluid therethrough;

[0082] a second state in which the vial assembly held by the first vial holder is in an inverted orientation in which fluid communication is established with the fluid communication component,

[0083] For drawing fluid through the fluid communication component.

[0084] The fluid communication component may include a syringe. The syringe may be used to inject fluid into the vial assembly (e.g., by pushing a plunger of a prefilled syringe) or to withdraw fluid from the vial assembly (e.g., by pulling a plunger of the syringe).

[0085] The medication preparation system may include a controller configured to select and operate the vial holder according to one or more of the following operating modes:

[0086] (a) an agitation mode in which the vial holder is repeatedly pivoted to mix the contents of the vial assembly;

[0087] (b) an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of a vial assembly held by the vial holder; and

[0088] (c) a fluid communication mode in which the vial holder remains stable in the first state or the second state.

[0089] The vial manipulator may further include a second vial holder configured to receive and maintain retention of a vial assembly, the second vial holder being pivotally coupled to the manipulator body; and a second pivot mechanism configured to pivot the second vial holder.

[0090] The vial manipulator may further include a rotation mechanism configured to rotate the manipulator body about a main axis of the manipulator body, thereby interchanging the positions of the first vial holder and the second vial holder. In some embodiments, the controller is further configured to instruct the fluid communication component to transfer fluid to the vial assembly when operating the first vial holder according to fluid communication mode (c).

[0091] According to a seventh aspect, there is provided a vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising:

[0092] a manipulator body defining a primary axis;

[0093] a first vial holder pivotably coupled to the first face of the manipulator body and configured to receive and maintain retention of a vial assembly;

[0094] a second vial holder pivotably coupled to the second face of the manipulator body and configured to receive and maintain retention of a vial assembly; and

[0095] A controller 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 operating modes:

[0096] a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial held by the vial holder;

[0097] b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; and

[0098] c. A fluid communication mode in which the vial holder remains stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

[0099] In some embodiments, two or more of the operating modes can be performed sequentially without removing the vial assembly from the vial holder.

[0100] In some embodiments, the system further includes a rotation mechanism configured to rotate the manipulator body about the main axis, and the controller is further configured to control the rotation mechanism and synchronize the rotation with the operating mode.

[0101] It should be noted that all features described herein with respect to a certain aspect may be applicable to any other aspect.

[0102] As referred to herein, a "vial" may include a closable container, formed, for example, of glass or plastic, containing a drug in liquid or powder form. The vial may be a disposable vial. The vial may be tubular or bottle-shaped, having a neck proximate to the vial opening. The vial may be capped with a lid.

[0103] As referred to herein, a "vial assembly" may include a vial by itself, or a vial with a vial adapter mounted thereon. A septum 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 septum may include a membrane, such as a pierceable membrane or a membrane having a closable passageway defined therethrough.

[0104] A vial adapter can be used as part of a vial assembly as described herein. A vial adapter can include a device that can be mounted on a vial to facilitate transfer of the vial itself (by grasping the adapter rather than the vial) and / or to facilitate transfer of fluid into or out of a vial. The vial adapter can provide closed access to the contents of the vial. The vial adapter can be a single-use, sterile device. Note that the terms "vial" and "vial assembly" are used interchangeably in this application.

[0105] As referred to herein, fluids generally include medications, diluents, saline solutions or water, or any other fluids used in the preparation of medications.

[0106] As referred to herein, a "syringe assembly" may include a separate syringe (such as a standard syringe) or a syringe with a connector attached. A syringe connector may be coupled to a needle hub of a syringe. The syringe connector may provide a closed pathway and may facilitate fluid transfer. A septum may be constructed as part of or mounted to the syringe connector so that when the syringe assembly is engaged with a vial assembly, the two septa may dock with each other. Note that the terms "syringe" and "syringe assembly" may be used interchangeably in this application.

[0107] The above-described aspects and features, as well as additional aspects and features, of the presently disclosed subject matter are further specified in the embodiments of the presently disclosed subject matter presented below.

[0108] 1. A vial manipulator for use in a robotic drug preparation system, the vial manipulator comprising:

[0109] a manipulator body defining a primary axis;

[0110] a first vial holder pivotably coupled to the manipulator body and configured to receive and hold a vial assembly;

[0111] a first pivot mechanism for pivoting the first vial holder about a first axis extending outwardly from the body in a first direction;

[0112] a second vial holder pivotably coupled to the manipulator body and configured to receive and hold a vial assembly; and a second pivot mechanism for pivoting the second vial holder about a second axis extending outwardly from the body in a second direction different from the first direction.

[0113] 2. The vial manipulator of embodiment 1, wherein the first direction and the second direction define an angle of at least 90 degrees therebetween.

[0114] 3. The vial manipulator of embodiment 1 or embodiment 2, wherein the first direction and the second direction define an angle of 180 degrees therebetween and are directly opposite to each other such that the first axis and the second axis are directly aligned.

[0115] 4. The vial manipulator according to any one of the preceding embodiments, wherein the first axis and the second axis are perpendicular to the main axis.

[0116] 5. The vial manipulator according to any one of the preceding embodiments, wherein each of the first pivot mechanism and the second pivot mechanism comprises a pivotal attachment of the respective vial holder to the manipulator body, wherein the respective first and second axes pass through the pivotal attachments.

[0117] 6. The vial manipulator of embodiment 5, wherein each of the first vial holder and the second vial holder comprises:

[0118] a pivot plate pivotably connected to a wall of the manipulator body at the pivot attachment;

[0119] a frame connected to and extending from the pivot plate, the frame being configured to receive and retain the vial assembly;

[0120] The pivoting of the pivot plate is configured to drive the frame, thereby changing the orientation of the vial assembly held by the frame.

[0121] 7. The vial manipulator of embodiment 6, wherein the frame is fixedly connected to the pivot plate.

[0122] 8. A vial manipulator according to embodiment 6 or embodiment 7, wherein the frame is at least partially open and includes a set of gripping arms extending within the interior of the frame for gripping onto at least a portion of the vial assembly.

[0123] 9. The vial manipulator of embodiment 8, wherein the at least a portion of the vial assembly comprises a top portion of a vial or an adapter mounted to a top portion of a vial,

[0124] The clamp arm is configured to snap fit onto the at least a portion of the vial assembly.

[0125] 10. The vial manipulator of any preceding embodiment, further comprising a rotation mechanism configured to rotate the manipulator body about the primary axis.

[0126] 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 the rotation mechanism.

[0127] 12. The vial manipulator according to any one of the preceding embodiments, 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.

[0128] 13. The vial manipulator of embodiment 12, wherein the vial assembly held by each of the vial holders is pivotally movable in respective first and second planes, each of the first and second planes intersecting and perpendicular to the first and second axes, respectively, and wherein respective third and fourth axes, both parallel to the primary axis, extend through the first and second planes; whereby in the initial orientation of the vial assembly held by the vial holder, the longitudinal axis of the respective vial assembly is aligned with the third and fourth axes, respectively.

[0129] 14. The vial manipulator according to any one of the preceding embodiments, wherein each of the first pivot mechanism and the second pivot mechanism comprises a respective actuator for enabling pivotal movement of the vial holder.

[0130] 15. The vial manipulator of embodiment 14, wherein the actuator is entirely contained within the housing of the manipulator body.

[0131] 16. The vial manipulator of embodiment 15, wherein the actuators of the first and second vial holders are symmetrically arranged side by side within the housing.

[0132] 17. The vial manipulator of any one of embodiments 14 to 16, wherein the actuator is controlled by a controller.

[0133] 18. The vial manipulator according to any one of embodiments 14 to 17, wherein each actuation

[0134] The device comprises a motor, and the respective vial holder is connected to the motor via a shaft bearing.

[0135] 19. The vial manipulator of embodiment 17, wherein the controller is 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 operating modes:

[0136] a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial assembly held by the vial holder;

[0137] b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; and

[0138] c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

[0139] 20. The vial manipulator of embodiment 19, wherein the controller is configured to operate each of the first vial holder and the second vial holder according to all of the operating modes (a)-(c).

[0140] 21. The vial manipulator of embodiment 19 when dependent on embodiment 13, and when the controller operates the vial holder according to the agitation mode (a), by repeatedly pivoting the vial holder so that the longitudinal axis of the vial assembly held by the vial holder defines a varying angle of less than 90 degrees relative to the opposite side of the third axis or the fourth axis, respectively, for causing the vial assembly to swing in a pendulum-like motion.

[0141] 22. The vial manipulator of embodiment 19 when dependent on embodiment 13, and when the controller operates the vial holder according to the orientation setting mode (b), the vial holder is pivoted so that the longitudinal axis of the vial assembly held by the vial holder defines a fixed angle between 0 degrees and 180 degrees relative to the third axis or relative to the fourth axis, respectively.

[0142] 23. The vial manipulator of embodiment 22, wherein the pivotal movement of the vial assembly in the orientation setting mode (b) is configured to flip the vial assembly through an angle of 180 degrees.

[0143] 24. The vial manipulator of embodiment 17 when dependent on embodiment 10, wherein the controller is further configured to control the rotation mechanism to set the rotational position of the first vial holder and the second vial holder.

[0144] 25. A vial manipulator according to embodiment 17, wherein the vial manipulator constitutes part of a robotic drug preparation system, the robotic drug preparation system further comprising an operating module configured to dock with a vial assembly held by the vial manipulator, and the controller further configured to control the operating module.

[0145] 26. A vial manipulator according to embodiment 25, wherein the operating module is a reconstitution / dilution module including a fluid insertion component, and the vial manipulator is spatially arranged relative to the fluid insertion component so that the corresponding vial assembly held by one of the first vial holder and the second vial holder is positioned below the fluid insertion component.

[0146] 27. The vial manipulator of embodiment 26 when dependent upon embodiment 19, wherein the controller is configured to operate the vial holder according to the fluid communication mode (c) to introduce fluid into the vial assembly via the fluid insertion component.

[0147] 28. A vial manipulator according to embodiment 25, wherein the operating module includes a fluid suction module, the fluid suction module includes a fluid suction component, and the vial manipulator is spatially arranged relative to the fluid suction component so that the vial assembly held by one of the first vial holder and the second vial holder is positioned above the fluid suction component.

[0148] 29. The vial manipulator of embodiment 28 when dependent upon embodiment 19, wherein the controller is configured to operate the vial holder according to the fluid communication mode (c) to withdraw fluid via the fluid withdrawal component.

[0149] 30. The vial manipulator of embodiment 25, wherein the operating module comprises an articulated arm, the vial manipulator being spatially positioned such that only one of the first vial holder and the second vial holder is positioned within a reach of the arm, while the other vial holder is outside the reach.

[0150] 31. A method of controlling a vial manipulator of a robotic medication preparation system, the vial manipulator comprising a manipulator body and first and second vial holders pivotably connected to the manipulator body, the method comprising:

[0151] selectively pivoting the first vial holder about a first axis extending outwardly from the manipulator body in a first direction; and

[0152] The second vial holder is selectively pivoted about a second axis extending outwardly from the manipulator body in a second direction different from the first direction.

[0153] 32. A method according to embodiment 31, wherein the first direction and the second direction define an angle of at least 90 degrees between them.

[0154] 33. A method according to embodiment 31 or embodiment 32, wherein the first direction and the second direction define an angle of 180 degrees between them and are directly opposite to each other so that the first axis and the second axis are directly aligned.

[0155] 34. A method according to any one of embodiments 31 to 33, wherein the first axis and the second axis are perpendicular to the main axis.

[0156] 35. A method according to any one of embodiments 31 to 34, wherein each of the first vial holder and the second vial holder comprises: a pivot plate that is pivotally connected to a wall of the manipulator body; and a frame that is connected to and extends from the pivot plate, the frame being configured to receive and hold the vial assembly; wherein the selective pivoting comprises pivoting the pivot plate while simultaneously driving the frame, thereby changing the orientation of the vial assembly held by the frame.

[0157] 36. A vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising:

[0158] a manipulator body defining a primary axis;

[0159] a first vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly;

[0160] a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; and

[0161] A rotation mechanism is configured to rotate the manipulator body about the main axis.

[0162] 37. The vial manipulator of embodiment 36 further comprising a first pivot mechanism for pivoting the first vial holder about a first axis extending outward from the body in a first direction; and a second pivot mechanism for pivoting the second vial holder about a second axis extending outward from the body in a second direction.

[0163] 38. The vial manipulator of embodiment 37, wherein the first axis and the second axis are perpendicular to the main axis.

[0164] 39. The vial manipulator of any one of embodiments 36 to 38, wherein each of the first vial holder and the second vial holder comprises:

[0165] a pivot plate pivotably connected to a side wall of the manipulator body;

[0166] a frame connected to and extending from the pivot plate, the frame being configured to receive and retain the vial assembly;

[0167] wherein pivoting of the pivot plate moves the frame to at least partially change the orientation of the vial assembly held by the frame.

[0168] 40. The vial manipulator of any one of embodiments 36 to 39, wherein the vial assembly held by each of the vial holders is movable in a first plane and a second plane, the first plane and the second plane intersecting the first axis or the second axis, respectively, and a third axis and a fourth axis, both parallel to the major axis, extending through the first plane and the second plane; each of the third axis and the fourth axis being perpendicular to the first axis and the second axis, respectively; whereby in the initial orientation of the vial assembly held by each of the vial holders, the long axis of the vial assembly is aligned with the third axis and the fourth axis, respectively.

[0169] 41. The vial manipulator of any one of embodiments 36 to 40, wherein each of the first pivot mechanism and the second pivot mechanism comprises an actuator for pivoting the vial holder.

[0170] 42. The vial manipulator of embodiment 41, wherein the actuator is controlled by a controller.

[0171] 43. The vial manipulator of embodiment 42, wherein the controller is configured to independently select and operate the vial according to one or more of the following operating modes:

[0172] Each of the first vial holder and the second vial holder:

[0173] a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial assembly held by the vial holder;

[0174] b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; and

[0175] c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

[0176] 44. The vial manipulator of embodiment 42, wherein the controller is further configured to control the rotation mechanism to set the rotational position of the first vial holder and the second vial holder.

[0177] 45. A method of controlling a vial manipulator of a robotic medication preparation system, the vial manipulator comprising a manipulator body having a main axis and first and second vial holders pivotably connected to the manipulator body, the method comprising:

[0178] receiving corresponding first and second vial assemblies at the first and second vial holders;

[0179] selectively pivoting at least one of the first vial holder and the second vial holder; and

[0180] The manipulator body is rotated about its primary axis to change the position of the first and second vial holders.

[0181] 46. ​​The method of embodiment 45, wherein selectively pivoting comprises repeatedly pivoting the first vial holder to agitate the vial assembly held by the first vial holder while holding the second vial holder stationary.

[0182] 47. The method of embodiment 46, further comprising inserting fluid into the second vial assembly held by the second vial holder before rotating the manipulator body.

[0183] 48. The method of embodiment 45, wherein selectively pivoting comprises pivoting the first vial holder 180 degrees from an initial orientation to hold the first vial assembly in an inverted orientation.

[0184] 49. The method of embodiment 48, further comprising aspirating fluid from the first vial assembly held by the first vial holder before rotating the manipulator body.

[0185] 50. A robotic drug preparation system, comprising:

[0186] A vial manipulator, the vial manipulator comprising:

[0187] a manipulator body defining a primary axis;

[0188] a first vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly;

[0189] a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; and

[0190] a rotation mechanism configured to rotate the manipulator body about the main axis; and

[0191] an operating module having an operating area and configured to dock with a vial assembly at the operating area; and a rotation mechanism configured to rotate the manipulator body to move 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.

[0192] 51. A system according to embodiment 50, wherein the operation module includes a fluid insertion component and / or a fluid aspiration component.

[0193] 52. A system according to embodiment 51, wherein the fluid insertion component and / or fluid aspiration component comprises a syringe.

[0194] 53. The system of embodiment 50, wherein the operation module comprises an articulatable arm having a distal end configured to engage a vial assembly.

[0195] 54. A system according to embodiment 53, wherein the operating area includes an area within the reach of the distal end of the arm.

[0196] 55. A robotic drug preparation system, comprising:

[0197] A vial manipulator, the vial manipulator comprising:

[0198] Manipulator body;

[0199] a first vial holder configured to receive and maintain retention of a vial assembly, the first vial holder being pivotably coupled to the manipulator body; and

[0200] a first pivot mechanism configured to pivot the first vial holder;

[0201] an operating module spatially arranged relative to the first vial holder and configured to hold a fluid communication component for docking with the vial assembly;

[0202] wherein the first pivot mechanism is configured to pivot the first vial holder

[0203] To present the following status:

[0204] a first state in which the vial assembly held by the first vial holder is in an upright orientation in which fluid communication is established with the fluid communication component for inserting a fluid therethrough;

[0205] A second state in which the vial assembly held by the first vial holder is in an inverted orientation in which fluid communication is established with the fluid communication component for withdrawing fluid therethrough.

[0206] 56. A system according to embodiment 55, wherein the fluid communication component includes a syringe.

[0207] 57. The system of embodiment 55 or embodiment 56, comprising a controller configured to select and operate the first vial holder according to one or more of the following operating modes:

[0208] (a) an agitation mode in which the vial holder is repeatedly pivoted,

[0209] for mixing the contents of the vial assembly;

[0210] (b) an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of a vial assembly held by the vial holder; and

[0211] (c) a fluid communication mode in which the vial holder remains stable in the first state or the second state.

[0212] 58. The system of any one of embodiments 55 to 57, further comprising:

[0213] a second vial holder configured to receive and maintain retention of a vial assembly, the second vial holder being pivotably coupled to the manipulator body; and

[0214] A second pivot mechanism is configured to pivot the second vial holder.

[0215] 59. The system of embodiment 58 further comprising a rotation mechanism configured to rotate the manipulator body about a main axis of the manipulator body, thereby interchanging positions of the first vial holder and the second vial holder.

[0216] 60. A vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising:

[0217] a manipulator body defining a primary axis;

[0218] a first vial holder pivotably coupled to the first face of the manipulator body and configured to receive and maintain retention of a vial assembly;

[0219] a second vial holder pivotably coupled to the second face of the manipulator body and configured to receive and maintain retention of a vial assembly; and

[0220] a controller 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 operating modes:

[0221] a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial held by the vial holder;

[0222] b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; and

[0223] c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

[0224] 61. The vial manipulator of embodiment 60, wherein two or more of the operating modes are capable of being performed sequentially without removing the vial assembly from the vial holder.

[0225] 62. The vial manipulator of embodiment 60 or 61, further comprising a rotation mechanism configured to rotate the manipulator body about the main axis, wherein the controller is further configured to control the rotation mechanism and synchronize the rotation with the operating mode. BRIEF DESCRIPTION OF THE DRAWINGS

[0226] In order to better understand the subject matter disclosed herein and to illustrate how it may be implemented in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0227] Figure 1 is a schematic diagram of a vial manipulator according to one embodiment of the disclosed subject matter;

[0228] Figures 2A to 2C is a schematic diagram of the pivotal movement of a vial assembly held by a vial holder according to an embodiment of the presently disclosed subject matter;

[0229] Figures 3A to 3D is a schematic diagram of an arrangement of a vial holder coupled to a body of a vial manipulator according to an embodiment of the presently disclosed subject matter;

[0230] Figure 4 is a schematic diagram of a spatial arrangement of an operation module and a vial manipulator in a drug preparation system according to an embodiment of the presently disclosed subject matter;

[0231] Figures 5A to 5B is a schematic diagram of an interface between a vial manipulator and an operating module constituting a fluid communication module according to an embodiment of the presently disclosed subject matter;

[0232] Figures 6A to 6B is an isometric view of a vial holder pivotably connected to a vial manipulator according to one embodiment of the presently disclosed subject matter;

[0233] 7A to 7B shows a vial manipulator holding a vial assembly in various orientations according to an embodiment of the disclosed subject matter;

[0234] Figure 8is an isometric view of a vial manipulator according to one embodiment of the disclosed subject matter;

[0235] Figures 9A to 9B According to an embodiment of the presently disclosed subject matter, for example 7A to 7B a cross-sectional view of the vial manipulator shown;

[0236] FIG. 10A to FIG. 10B is a schematic diagram of an arrangement comprising a vial manipulator and an operating module constituting a reconstitution / dilution module according to one embodiment of the presently disclosed subject matter ( Figure 10A ) and diagram ( Figure 10B );

[0237] Figures 11A to 11B is a schematic diagram of an arrangement including a vial manipulator and an operating module constituting a fluid aspiration module according to one embodiment of the presently disclosed subject matter ( Figure 11A ) and diagram ( Figure 11B );

[0238] Figure 12 is a side view of another vial manipulator structure according to one embodiment of the presently disclosed subject matter;

[0239] Figure 13 is a schematic diagram of syringe assembly and vial assembly components that can be used in a medication preparation system and interfaced with one another according to an embodiment of the presently disclosed subject matter; and

[0240] Figure 14A is an isometric view of a vial manipulator according to one embodiment of the disclosed subject matter;

[0241] Figure 14B According to one embodiment of the presently disclosed subject matter Figure 14A an enlarged top view of the vial holder of the vial manipulator shown; and

[0242] Figure 15 A vial manipulator is shown holding a vial assembly in various orientations according to one embodiment of the disclosed subject matter. DETAILED DESCRIPTION

[0243] refer to Figure 1 , which is a schematic diagram of a vial manipulator according to one embodiment of the disclosed subject matter.

[0244] In the example shown, the vial manipulator 101 includes a manipulator body 103 having a major axis MA. In some embodiments, the body 103 is elongated, and its length can correspond to the height of the vial assembly (e.g., as measured from the bottom of the vial to the uppermost surface of the vial assembly). In one example, the body 103 can be at least as long as the vial assembly. In some examples, the dimensions of the body 103 can be independent of the vial assembly. The manipulator body can be cylindrical or have a generally rounded profile, or alternatively, be rectangular, square, triangular, or have a generally polygonal profile defining multiple faces.

[0245] As further shown, manipulator body 103 is rotatably mounted on platform 105. A rotation mechanism 107, for example comprising at least one actuator (eg, motor, not shown), is configured to rotate the manipulator body relative to the platform about a manipulator body main axis.

[0246] A plurality of vial holders are connected to the manipulator body, wherein each vial holder is configured to receive and hold a vial assembly. In the example shown, two vial holders 109, 111 are connected to the manipulator body. Note that the number of vial holders connected to and extending from the manipulator body can range from 1-4 vial holders, 1-10 vial holders, 2-4 vial holders, 2-6 vial holders, or intermediate, greater, or lesser numbers.

[0247] Each of the vial holders can be pivoted about its own pivot axis via a pivot mechanism 113, which includes one or more actuators, such as motors. As shown, the vial holder 109 can pivot about a first axis 1A extending outward from the manipulator body in a first direction, and the vial holder 111 can pivot about a second axis 2A extending outward from the manipulator body in a second direction different from axis 1A. In some embodiments, axes 1A and 2A are perpendicular to the main axis MA. It should be understood herein that, for the purposes of this specification, the first axis 1A should be understood to extend along a vector originating from the body 103 and extending toward the first vial holder 109, and the second axis 2A should be understood to extend along a vector originating from the body 103 and extending toward the second vial holder 111. Generally, the pivot axis of a vial holder should be understood herein to extend along a vector originating from the body and extending toward the vial holder.

[0248] In some embodiments, each of the vial holders extends from a different face of the housing of the manipulator body. In the specific embodiment shown in the figure, the vial holders are directly opposite each other relative to the manipulator body, facing in opposite directions so that their pivot axes 1A and 2A are directly aligned.

[0249] In other embodiments, two or more vial holders may extend from the same face of the manipulator body housing.

[0250] In the illustrated example, each of the vial holders includes a pivot plate 115 that is coupled to the manipulator body via a pivot attachment 117. The respective pivot axes (axes 1A, 2A) of each of the vial holders pass through the pivot attachment. Note that the structure of the pivot attachment is not limited to a pivot plate, and other elements that allow the vial holder to pivot and are shaped so as not to interfere with the vial assembly during its pivoting motion may be used.

[0251] In the illustrated example, each of the vial holders includes a frame 119 connected to and extending from a pivot plate, the frame being configured to hold a vial assembly 121. In some embodiments, the frame can be fixedly connected to the pivot plate such that pivoting of the plate moves the frame together, thereby moving the vial assembly held by the frame. In some embodiments, the frame can be rotatably connected to the pivot plate. The frame can generally be configured to hold the vial assembly at any portion of the assembly, whether on the vial itself (e.g., at the neck portion, at the opening portion), or on a vial adapter mounted to the vial.

[0252] It should be understood herein that although the vial holders have been illustrated herein as being comprised of a pivot plate and a frame, in some examples, any, some, or all of the vial holders may be comprised solely of a frame that is pivotally mounted directly to the body. In some examples, the pivot plate may be located within the body, and the frame may extend outwardly from the pivot plate. Generally speaking, the vial holders may have any structure suitable for pivoting a vial assembly held therein.

[0253] In an initial orientation (defined herein for purposes of explanation), the vial assembly 121 held by the holder extends in an upright orientation along the third axis 3A (for the vial holder 109) or the fourth axis 4A (for the vial holder 111), with the top of the vial (or an adapter mounted thereon) vertically above the bottom of the vial.

[0254] Each of the vial holders is configured to hold and move a vial assembly along a respective plane that intersects the pivot axis (axis 1A or 2A) of the respective holder, with axes 3A and 4A, respectively, extending within the respective planes.

[0255] Control of the movement of each of the vial holders and the rotation of the manipulator body is provided by at least one controller 123. The controller 123 may be programmed to control the pivoting mechanism 113 as well as the rotating mechanism 107 and synchronize their operation.

[0256] 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:

[0257] a. Agitation mode, in which the vial holder is repeatedly pivoted to agitate the vial assembly so that its contents (e.g., powder and fluid (such as saline), two or more types of fluids, etc.) will be mixed. Optionally, agitation is performed with an oscillating or pendulum-like or rotational or arcuate movement of the vial holder.

[0258] Agitation parameters, such as agitation duration, extent of oscillatory movement, speed of movement, and / or other parameters, may be selected based on the specific type of drug being mixed (such as based on prescription instructions). In some embodiments, the vial holder is pivoted such that the vial assembly held therein is agitated until no or only a few particles of drug powder remain visible.

[0259] b. An orientation setting mode, in which the vial holder is pivoted about 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 an initial orientation to flip the vial assembly. The vial assembly's orientation can be set relative to axis 3A such that the long axis of the vial assembly, aligned along axis 3A in both the initial position (0-degree pivot angle) and the flipped position (180-degree pivot angle), defines an angle α relative to axis 3A. (Similarly, the second vial assembly is oriented relative to axis 4A.)

[0260] c. A fluid communication mode in which the vial holder remains stable, thereby maintaining the corresponding vial assembly in a selected orientation to enable fluid transfer to or from the vial. In the fluid communication mode, the vial holder can be brought into alignment (e.g., vertically, horizontally, or diagonally) with the vial assembly and the fluid insertion component or fluid withdrawal component of the drug preparation system, optionally by rotation of the manipulator body about a primary axis, to enable fluid transfer therebetween.

[0261] It is noted that at least one controller can be configured to control each of the vial holders independently of the other vial holders, thereby selecting an operating mode for each specific vial holder. The controller can be configured to consider the current operating mode of one of the vial holders and set the operating mode of the other vial holder accordingly. The controller can also be configured to define the timing and / or extent and / or speed of rotation of the manipulator body about the primary axis, optionally in relation to the operating mode of the vial holder.

[0262] An example of an operating scheme for a vial manipulator comprising, for example, two vial holders is provided below:

[0263] agitating the first vial holder and holding the second vial holder steady in any orientation;

[0264] Agitate both vial holders;

[0265] holding two vial holders stable relative to each other in the same or different orientations;

[0266] agitating the first vial holder, holding the second vial holder steady, and then rotating the manipulator body to interchange the positions of the two vial holders;

[0267] Whether one or more of the vial holders is stable in any orientation or being agitated, the manipulator body is rotated.

[0268] Figures 2A to 2C is a schematic diagram of the pivotal motion of a vial assembly held by a vial holder according to an embodiment of the presently disclosed subject matter. It should be understood herein that Figures 2A to 2C The schematic diagrams of the vial assembly in may include just the vial or the vial with an adapter mounted thereon.

[0269] exist Figure 2A In the embodiment of the present invention, a vial holder (not shown) is pivoted, causing the corresponding vial assembly 201 to pivot relative to axis 3A, optionally repeatedly and along an arc 203, for example, the long axis or vial assembly axis VA is pivoted along arc 203, for agitating the vial. The angle α formed between the long axis of the vial assembly 201 (vial assembly axis VA) and the axis 3A can be in the range of, for example, 1 degree to 90 degrees on each side of the axis 3A.

[0270] exist Figure 2B , a vial holder (not shown) is pivoted such that the corresponding vial assembly pivots from its initial upright orientation to an inverted, upside-down orientation with the vial assembly axis VA aligned with axis 3 A. Optionally, the vial assembly remains in the inverted orientation over time, e.g., to allow fluid communication to occur.

[0271] exist Figure 2C , the vial assembly pivots from its initial upright orientation to a pivoted orientation in which the vial assembly optionally remains stable (over time), wherein the vial assembly axis VA defines an angle β relative to axis 3 A. Angle β may be, for example, in the range of 1 degree to 179 degrees.

[0272] Figures 3A to 3D is a schematic diagram of an arrangement of a vial holder coupled to the body of a vial manipulator according to an embodiment of the disclosed subject matter.

[0273] 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 of the vial holders may pivot about an axis 305 that extends from the manipulator body in a different direction than the pivot axes of the other vial holders.

[0274] exist Figure 3A and Figure 3D In the example of FIG, four vial holders are connected to the manipulator body and extend in different directions (e.g., the frame of each vial holder extends radially outward in a different direction than the frames of the other vial holders). Alternatively, the four vial holders may be arranged symmetrically, with the angle between adjacent vial holders being 90 degrees.

[0275] exist Figure 3B In the example of , two vial holders are connected to the manipulator body and extend in different directions.

[0276] exist Figure 3C In the example of , two vial holders are connected to the manipulator body and extend directly through the manipulator body in opposite directions. In the case of a cylindrical (or other circular profile) manipulator body, the two vial holders may be diametrically opposed to each other.

[0277] Note that the manipulator body shown herein has Figures 3A to 3C , but other manipulator body contours are also conceivable, including polygonal contours or even arbitrary contours, such as Figure 3D shown.

[0278] Figure 4 is a schematic diagram of the spatial arrangement of an operation module and a vial manipulator in a drug preparation system according to an embodiment of the presently disclosed subject matter.

[0279] In this figure, a vial manipulator 401, such as described elsewhere in this application, is shown as part of a medication preparation system 403 that includes at least one operating module 405 configured to interface directly or indirectly with a vial assembly 407 held by the vial manipulator.

[0280] Some examples of operation modules 405 include:

[0281] The fluid communication module, for example, is configured to insert a module into a vial of fluid, or is configured to draw fluid from a vial. In some embodiments, the fluid communication module includes a syringe with a needle that can be at least partially advanced into the vial assembly for injecting fluid into the vial and / or for drawing fluid from a vial. Optionally, the syringe is in fluid communication with a fluid container (e.g., an IV bag). The syringe can be connected to the IV bag via a selective connector such as a valve (e.g., a one-way valve, a two-way valve, a three-way valve), a stopcock, a selector, or other connectors.

[0282] An arm (e.g., an articulated robotic arm) or other movable element configured to engage the vial assembly and optionally lift the vial assembly. The arm can be capable of transferring the vial assembly, e.g., removing the vial assembly from the vial manipulator and / or bringing the vial assembly to the vial manipulator. An imager, e.g., a camera, can image the vial assembly, e.g., for purposes of determining / verifying the type of drug, verifying the amount of fluid in the vial, inspecting the vial for the presence of particles, verifying drug information such as from a prescription label or sticker, etc.

[0283] An attachment / removal unit, which can, for example, attach or remove a connector or an adapter to or from a vial.

[0284] A marking unit can mark or otherwise identify a vial, for example, according to the vial's contents.

[0285] In some embodiments, the operating module 405 operates within a defined area of ​​the system, schematically designated as an operating area 409. The operating area can define a limited surface area and / or a limited volume within which interface between the operating module and a vial assembly held by a vial manipulator occurs. In examples where the operating module comprises a robotic arm, the arm can have a defined operating radius such that system components within the operating radius fall within the arm's reach, while components outside the operating radius cannot be reached by the arm.

[0286] In the exemplary system configuration shown, the vial manipulator 401 is positioned relative to the operating module such that only some 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 this configuration, rotation of the manipulator body 415 about the main axis MA (optionally the long axis of the manipulator body) can interchangeably position one of the vial holders within the operating area and another vial holder outside the operating area.

[0287] The arrangement in which the rotation of the manipulator body interchanges the spatial position of the vial holder (and thus the vial assembly held therein) can be advantageous because the operating module can function within a limited area without having to "extend" to a greater extent to interface with the vial assembly. In the example of a robotic arm, this arrangement can enable the use of a shorter, more compact arm and can potentially reduce the need to move the arm to a greater extent, thereby "freeing" the arm to perform additional actions simultaneously.

[0288] In an example of use, in which the operating module constitutes a fluid insertion component, for example: a vial assembly 407 held by a vial holder 411 can be injected with fluid via the fluid insertion component; then, the manipulator body can be rotated 180 degrees to place the vial holder 411 together with the vial assembly 407 outside the operating area, and the vial holder 413 together with its vial assembly 417 is placed in the operating area; then, the vial assembly 407 can be agitated to mix its contents, and the vial assembly 417 can now also be docked with the fluid insertion component to be injected with fluid.

[0289] Figures 5A to 5B is a schematic diagram of an interface between a vial manipulator and an operating module constituting a fluid communication module, according to an embodiment of the disclosed subject matter.

[0290] exist Figure 5A In FIG. 5 , a vial manipulator 501 is positioned relative to a dilution / reconstitution module 519 of a medication preparation system, which is configured for injecting fluid into a vial (eg, for reconstituting a medication contained within the vial).

[0291] The vial manipulator includes one or more vial holders 503 (one vial holder is shown in the illustrated embodiment) connected to a body 505 of the vial manipulator, each holder including a pivot plate 517 pivotably connected to the body, and a frame 511 extending from the pivot plate and away from the body to hold a vial assembly 507. Pivoting the pivot plate about a pivot axis 509 moves the frame to change the orientation of the vial assembly. To interface with the dilution / reconstitution module, the vial assembly is pivoted to an orientation in which the vial assembly is aligned with the fluid insert 515 of the dilution / reconstitution module. In one example, the orientation is an upright orientation in which the vial assembly is aligned vertically below the fluid insert.

[0292] In a similar way, in Figure 5B, the vial manipulator is positioned relative to a fluid aspiration module 521, which is configured to aspirate fluid from a vial (e.g., for transferring the 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 pivoted to an orientation in which it is aligned with the fluid aspiration component 525 of the fluid aspiration module. In one example, the orientation is an inverted orientation in which the vial assembly is aligned vertically above the fluid aspiration component.

[0293] It should be noted that fluid transfer between the vial assembly and the fluid communication component can generally be performed when direct alignment is achieved between the vial assembly and the fluid communication component. Generally, to insert a fluid into the vial assembly, the vial assembly needs to be oriented such that the opening 527 of the vial is positioned upward, e.g., so that the contents of the vial do not flow out of the vial and the fluid entering the vial will flow in the direction of gravity; to withdraw a fluid from the vial assembly, the vial assembly needs to be oriented such that the opening 527 is positioned downward, e.g., to ensure that fluid rather than gas is withdrawn from the vial and the flow out of the vial will be in the direction of gravity.

[0294] It should be noted that the fluid insertion component 515 and the fluid aspiration component 525 may each generally comprise a container capable of holding a fluid, which is used in conjunction with a force applied thereto to cause the fluid to be injected into or withdrawn from the container. Examples of containers include syringes, fluid bags, catheters or other tubes, and vials; the force that can be used to inject or withdraw the fluid may include pressure (e.g., applied by a pump), centrifugal force, gravity, and / or other suitable forces.

[0295] Figures 6A to 6B is an isometric view of a vial holder pivotably connected to the body of a vial manipulator according to one embodiment of the disclosed subject matter.

[0296] exist Figure 6A In the embodiment, the vial holder 601 includes a pivot plate 603 that is pivotally mounted to a wall of a manipulator body 605. A frame 609 is fixedly connected to the pivot plate and extends outwardly from the plate, away from the manipulator body. The frame 609 is partially open, such as a U-shape, for allowing the vial assembly 611 ( Figure 6B A set of clamping arms 613 extend inside the frame (for explanation purposes, see FIG. Figure 6B ( ) The gripping arms are shown without a frame. The gripping arms can be resilient (spring-like) so as to tightly grip a vial assembly received within the frame. Optionally, during insertion, the vial assembly is pressed or pushed onto the frame and gripped by the gripping arms. The vial assembly can be brought into and inserted into the frame automatically (such as via a robotic arm or other automated transfer device) and / or manually (such as by an operator of the medication preparation system).

[0297] As shown, the pivot plate is connected to the manipulator body so that the pivot axis 607 of the vial holder passes through the upper portion of the manipulator body. The axial position of the pivot axis (along the length of the manipulator body) can be defined so that sufficient space is maintained above and below the pivot axis to allow the vial assembly to extend along the pivot axis in both the upright and inverted orientations of the vial assembly.

[0298] Note that while a frame with gripping arms is shown herein, any suitable gripping device (eg, clamps, grippers, snaps, fasteners, or other shaped frame) may be used to perform reversible attachment of the vial assembly to the frame.

[0299] It should also be noted that while the frame is fixedly attached to the pivot plate such that the frame pivots with the plate, other embodiments may include an attachment that enables the frame to move to at least some extent, for example, a pivotal attachment of the frame to the pivot plate that enables the frame to at least partially pivot. In some examples, the frame may be directly connected to the manipulator body via any suitable connection arrangement, thereby allowing the frame to pivot to agitate the vial assembly held thereby. In some examples, the pivot plate may be located internal to the manipulator body.

[0300] 7A to 7B A vial manipulator is shown that holds a vial assembly in various orientations according to an embodiment of the presently disclosed subject matter. Figure 7A In the example of FIG, two vial holders 701, 705 are connected to the manipulator body 703 facing in opposite directions. The vial assembly 711 held at the holder 701 is shown in an initial upright orientation; the vial assembly 713 held at the holder 705 is slightly pivoted (e.g., during agitation of the vial assembly, or when the vial assembly is held stable in a pivoted orientation, such as for fluid transfer purposes). Figure 7B In the example of FIG, both vial holders are pivoted 180 degrees, thereby holding the vial assembly in an inverted (upside-down) orientation.

[0301] Figure 8 is an isometric view of a vial manipulator according to one embodiment of the disclosed subject matter.

[0302] Typically, the pivot mechanism of the vial holder includes or is operatively connected to one or more actuators, such as one or more motors, for driving movement of the pivot plate of the vial holder relative to the manipulator body.

[0303] In some embodiments, the actuator is housed within the manipulator body. Additionally or alternatively, the actuator may be external to the manipulator body and operably connected to the pivot plate.

[0304] In some embodiments, each actuator can be configured to drive movement of the pivot plate of a single vial holder. Alternatively, the actuator can be configured to drive movement of the pivot plates of two or more vial holders.

[0305] The actuator may include a motor, such as a servomotor, a hydraulic motor, a pneumatic motor, an electric motor, a magnetic motor, a mechanical actuator (such as a spring), a piston, and combinations thereof.

[0306] In this example, for purposes of explanation, the vial manipulator is shown with a portion of the outer housing of the manipulator body 803 removed. Two motors 805 (such as servomotors) are positioned side by side, each configured to drive movement of the respective vial holder to which it is attached. Power is supplied to the motors via cables 807, which extend, for example, as shown, through designated openings 809 defined in a rotatable platform 810 on which the manipulator body is mounted.

[0307] In some embodiments, as shown in this example, multiple motors (optionally, each motor driving the movement of a different vial holder) are arranged symmetrically relative to each other, such as within the housing of the manipulator body. In the example shown, two motors are aligned back to back. In another example, where there are four vial holders, they are arranged symmetrically, such as at 90-degree angles relative to each other. Other examples may include alternating configurations of motors arranged along the length of the manipulator body, such as where multiple motors are intermeshed with each other.

[0308] By arranging the actuators (e.g., motors) of the pivot mechanism in a compact arrangement, such as a back-to-back arrangement, an intermeshing arrangement, or other compact arrangement, the width 811 of the manipulator body (e.g., as measured between opposing walls of the housing 803) can be kept to a minimum. This allows for a compact configuration in which the vial holders are as close to each other as possible, yet still independently operable and without interfering with each other's movement. The compact arrangement of the pivot mechanism can further provide for the placement of multiple vial holders on the same manipulator body, thereby potentially reducing the overall footprint of the medication preparation system, as the vial manipulator can hold and move multiple vials within a relatively small, confined space.

[0309] In some embodiments, the distance measured across the manipulator body between the pivot plates of opposing vial holders is no longer than 15 cm, 10 cm, 5 cm, 4 cm, 3 cm, 2 cm, or intermediate or shorter distances.

[0310] Figures 9A to 9B According to an embodiment of the presently disclosed subject matter, for example 7A to 7B A cross-sectional view of the vial manipulator is shown.

[0311] As shown, each motor 901 can be connected to its associated vial holder, and more specifically to the vial holder's pivot plate 905, via a shaft bearing 903 that transfers the motor's rotation to the pivoting motion of the pivot plate. The shaft bearing 903 extends from the motor on the inside of the manipulator body's housing to the outside of the housing, where the pivot plate is located.

[0312] As further shown, the rotation mechanism of the manipulator body 907 is actuated by one or more actuators, such as motor 909. Motor 909 is connected to gear 911, such that rotation of the gear by the motor rotates the manipulator body relative to a platform 913 (e.g., a workbench) of the drug preparation system.

[0313] FIG. 10A to FIG. 10B is a schematic diagram of an arrangement comprising a vial manipulator and an operating module constituting a reconstitution / dilution module according to one embodiment of the presently disclosed subject matter ( Figure 10A ) and diagram ( Figure 10B ).

[0314] In some embodiments, a vial manipulator, for example as described herein, is used in conjunction with a reconstitution and / or dilution module that can obtain or receive a fluid from a fluid source (e.g., from an IV bag, a syringe, a container) and introduce the fluid into a vial in a selected volume in order to dilute a concentrated liquid drug or to reconstitute a dry powder drug by dissolving the powder in the fluid.

[0315] The fluid introduced by the module may include a diluent, such as saline, water, or other suitable fluid.

[0316] The volume of fluid introduced into the vial can be controlled based on the specific contents of the vial, for example, according to the prescription label and / or other instructions for the drug, so as to achieve a selected concentration or a selected total volume.

[0317] For example, the reconstitution and / or dilution modules described herein are configured for use with a plurality of disposable (optionally, single-use) components, such as IV bags, syringes, and connectors and / or adapters for use with these components. Optionally, the components are used with the module more than once, for example, a syringe can be used multiple times when used as a piston for, for example, aspirating and / or injecting fluids.

[0318] As shown in this example, the dilution and / or reconstitution module 1003

[0319] include:

[0320] -IV bag holder 1007, which is configured to hold an IV bag 1009 (bag in Figure 10B), for example by having a support member, such as a clamp, a hook and / or other suitable support member for maintaining retention of the IV bag;

[0321] - a syringe assembly manipulator 1011 configured to hold and manipulate a syringe assembly 1013. In some embodiments, the syringe assembly manipulator is operable to move the syringe assembly as a whole, such as axially moving the syringe toward or away from the vial manipulator. In some embodiments, the syringe assembly manipulator is configured to independently move components of the syringe assembly, such as axially moving the plunger of the syringe to aspirate or inject fluid;

[0322] - A selector 1015, such as a T-cock, positioned and configured to provide the syringe assembly to an IV bag (such as via Figure 10B 1016) or a switchable fluid connection to a vial assembly 1017 held at a vial manipulator 1019. In some embodiments, one or more one-way valves (not shown) may be used, wherein the one-way valves 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.

[0323] like Figure 10B As shown, the dilution and / or reconstitution module is positioned vertically above the vial manipulator so that a vial assembly held by holder 1020 of the vial manipulator can be aligned with a syringe assembly for transferring fluid, such as for injecting fluid into a vial.

[0324] The operation of the arrangement can be controlled by at least one controller 1021, which is configured to control the vial manipulator and the plurality of actuators 1023 of the dilution and / or reconstitution module. In some embodiments, the controller communicates with one or more imagers 1025 for verifying, identifying, and / or measuring data. Non-limiting examples of data collected via the imagers may include: the type and / or amount of fluid; the presence of powder particles in the vial after agitation of the vial; the presence of bubbles in the fluid; the volume of the fluid; and / or other data.

[0325] During an exemplary use, the controller instructs the actuator of the vial holder to hold the vial assembly in a stable, upright, non-pivoted orientation. The controller instructs the selector to place the syringe assembly in fluid communication with the IV bag and, by controlled pulling of the syringe plunger (via the syringe assembly manipulator), withdraw a defined volume of diluent from the IV bag. The controller then instructs the selector to place the syringe assembly in fluid communication with the vial assembly and inject the defined volume of diluent into the vial. The controller can then instruct the actuator of the vial holder to repeatedly pivot the vial assembly to agitate the filled vial and mix its contents. Optionally, the controller instructs the rotation mechanism of the vial manipulator to rotate the manipulator body about its axis, thereby changing the position of the vial assembly. For example, the rotation of the manipulator body can be performed before or after agitating the vial assembly.

[0326] In some embodiments, the filled vial remains held by the vial manipulator for use in the process of withdrawing the prepared drug product from the vial, e.g., as described below in Figures 11A to 11B As described in.

[0327] Figures 11A to 11B is a schematic diagram of an arrangement including a vial manipulator and an operating module constituting a fluid aspiration module according to one embodiment of the presently disclosed subject matter ( Figure 11A ) and diagram ( Figure 11B ).

[0328] In some embodiments, for example, a vial manipulator as described herein is used in conjunction with a fluid aspiration module that can aspirate fluid from a vial, such as a prepared medication from a vial, and optionally transfer the medication to an IV bag or other container for storage and / or administration of the medication to a patient.

[0329] The volume of medication withdrawn from the vial can be controlled based on need, such as according to a patient's prescription or other instructions.

[0330] For example, a fluid aspiration module as described herein is configured to be used with a plurality of disposable (optionally, single-use) components, such as IV bags, syringes, and connectors and / or adapters for use with these components. Optionally, a component is used with the module more than once, for example, a syringe can be used multiple times when used as a piston for aspirating and / or injecting fluids, for example.

[0331] As shown in this example, the fluid aspiration module 1103 includes:

[0332] - an IV bag holder 1107 configured to hold one or more IV bags 1109, such as by having a support upon which the bags can be positioned. Note that containers other than IV bags can be used to receive prepared medication drawn from vials;

[0333] - A syringe assembly manipulator 1111 configured to hold and manipulate a syringe assembly 1113. In some embodiments, the syringe assembly manipulator is operable to move the syringe assembly as a whole, such as axially moving the syringe toward or away from the vial manipulator. In some embodiments, the syringe assembly manipulator is configured to independently move components of the syringe assembly, such as axially moving the plunger of the syringe to aspirate or inject fluid.

[0334] like Figure 11B As shown, the fluid aspiration module can be moved, for example, slid to a position vertically below the vial manipulator 1122 so that the vial assembly 1124 held by the holder of the vial manipulator can be aligned with the syringe assembly of the fluid aspiration module for transferring fluid, for example, for aspirating fluid from a vial. In some embodiments, as shown, the syringe assembly can be moved horizontally on the frame 1126, for example, along the horizontal axis of the platform (workbench) 1129 or an axis parallel thereto.

[0335] The operation of the arrangement can be controlled by at least one controller 1121, which is configured to control the vial manipulator and the plurality of actuators 1123 of the fluid aspiration module. In some embodiments, the controller communicates with one or more imagers 1125, which are used to verify, identify, and / or measure data, such as verifying or identifying the type and / or amount of drug in the vial; verifying and / or measuring the amount of drug aspirated into the syringe by the module; verifying the position of the syringe assembly and / or vial assembly, and / or other data.

[0336] During an exemplary use, the controller instructs the vial holder actuator to hold the vial assembly in a stable, inverted orientation. The controller instructs the syringe assembly manipulator to place the syringe assembly in fluid communication with the vial assembly. The controller then instructs the syringe assembly manipulator to withdraw a defined volume of medication from the vial by controlled pulling of the syringe plunger.

[0337] Optionally, the controller instructs the rotation mechanism of the vial manipulator to rotate the manipulator body about its axis to change the position of the vial assembly. For example, after aspirating fluid from a vial assembly, the manipulator body can be rotated to position a new vial assembly so that the drug can be aspirated therefrom.

[0338] Optionally, the controller instructs the syringe assembly manipulator to position the syringe assembly in fluid communication with the IV bag for injecting the prepared medication into the bag. Optionally, placing the syringe assembly in fluid communication with the IV bag is performed by moving (e.g., sliding) the syringe manipulator along the frame into a position where it is aligned with the IV bag.

[0339] Figure 12 is a side view of another vial manipulator structure according to one embodiment of the disclosed subject matter.

[0340] In the illustrated example, two vial holders are connected to a pivotable rod 1207, with the vial holders facing in opposite directions. The frame 1209 of each holder is connected to opposite ends of the rod so that the vial assemblies held by the holders are in opposite orientations relative to each other (one vial assembly is upright and the other is inverted). In use, pivoting the rod about a pivot axis passing through the pivot point 1211 causes the vial assembly to invert so that the inverted vial assembly is now upright, and vice versa.

[0341] The rod 1207 itself may constitute or be connected to a manipulator body that is configured for rotation relative to a platform (not shown) by, for example, a rotation mechanism as described herein. Rotation of the vial manipulator may interchange the position of the vial holder.

[0342] Figure 13 is a schematic illustration of syringe assembly and vial assembly components that can be used in a medication preparation system and interfaced with one another, according to an embodiment of the disclosed subject matter.

[0343] Vial assembly 1301 includes a vial 1303, such as a standard medicine vial. Optionally, a vial adapter 1302 is attached to the top portion of the vial and can be gripped for transferring the vial. Optionally, a vial septum 1305 is configured as part of the vial adapter or is separately mounted to the vial adapter to at least partially seal access to the vial.

[0344] Syringe assembly 1307 includes a syringe 1309, such as a standard syringe. The syringe may include a needle 1311 or cannula suitable for transferring fluids and optionally suitable for penetrating a septum or other seal or structure to enter a container, such as a vial. The needle may include a bevel at its distal portion.

[0345] Optionally, the syringe connector 1313 is connected to the needle hub of the syringe.

[0346] Optionally, the syringe septum 1315 is constructed as part of the connector or is separately mounted to the connector.

[0347] In use, fluid communication can be established between the syringe assembly and the vial assembly, wherein the syringe needle can optionally be advanced into and / or through the vial septum and / or into the vial itself. In some embodiments, fluid communication can be established only when the vial septum and the syringe septum contact each other, and optionally a reaction force above a selected force threshold is applied to each other.

[0348] Figure 14A is an isometric view of a vial manipulator according to one embodiment of the disclosed subject matter.

[0349] The vial manipulator 1401 of this example includes a manipulator body 1403 mounted on a disc-shaped platform 1405, which is used to rotate the manipulator body about its long axis. Two vial holders 1407 are connected to opposite outer surfaces of the housing of the manipulator body. Each vial holder includes: a pivot plate 1409 that is pivotally connected to the body; a rectangular frame 1411 that is formed as a continuous extension of the top portion of the pivot plate; and a set of gripping arms 1413 that extend outwardly from the frame, away from the manipulator body, for receiving a vial assembly. Figure 14B As shown in FIG. 1 , which is an enlarged top view of the vial holder, the gripping arms are configured to snap fit onto the vial assembly when the vial assembly is pushed inwardly toward the pivot plate. (In this example, the gripping arms press to obtain a hold on the vial adapter 1415 mounted to the vial top).

[0350] The clamping arms are configured to move away from each other to allow insertion of a vial assembly, and then resiliently rebound toward each other to clamp onto the vial assembly. In this example, this is achieved 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 clamping arms between the ends of the clamping arms connected to the frame. The spring is configured to extend longitudinally when the clamping arms are pushed away from each other (during insertion of the vial assembly), and return to its compressed state to pull the clamping arms toward each other so that the vial assembly is gripped between the clamping arms.

[0351] Note that other resilient members (eg, elastic bands) may be used in addition to or instead of springs for pulling the clamping arms toward each other.

[0352] Figure 15 A vial manipulator is shown that holds a vial assembly in various orientations according to one embodiment of the presently disclosed subject matter. Figure 15In the example shown, four vial holders 1501, 1502, 1503, and 1504 are connected to a manipulator body 1505, facing directions offset 90 degrees from one another. In the illustrated example, the manipulator body 1505 has a polygonal horizontal cross-sectional shape having four walls, with each of the vial holders extending outwardly from a respective wall of the manipulator body 1505.

[0353] Two vial assemblies 1511 and 1513, held at holders 1501 and 1503, respectively, are shown in an initial upright orientation; and vial assemblies 1512 and 1514, held at holders 1502 and 1504, respectively, are shown in an inverted orientation (e.g., during agitation of the vial assemblies, or when one or more of the vial assemblies is held stable in a pivoted orientation, such as for fluid transfer purposes). It should be understood that although vial assembly 1512 has been shown connected to a syringe, the vial assembly does not necessarily need to be connected to a syringe. In fact, in some examples, a vial manipulator may also hold and pivot the vial assembly together with the syringe.

[0354] A corresponding pivot plate (not shown) for each of the vial holders is located within the manipulator body 1505, and a corresponding frame extends outwardly from the pivot plate. It should be understood herein that the descriptions provided above with respect to the pivoting of the vial holders and the rotation of the manipulator body for the various examples also apply mutatis mutandis to the vial holders 1501, 1502, 1503, and 1504 and the manipulator body 1505.

Claims

1. A vial manipulator for use in a robotic drug preparation system, the vial manipulator comprising: a manipulator body defining a primary 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 about a first axis extending outwardly from the body in a first direction; a second vial holder pivotably coupled to the manipulator body and configured to receive and hold a vial assembly; as well as A second pivot mechanism is provided for pivoting the second vial holder about a second axis extending outwardly from the body in a second direction different from the first direction.

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

3. The vial manipulator of claim 1 or claim 2, wherein the first direction and the second direction define an angle of 180 degrees therebetween and are directly opposite one another such that the first axis and the second axis are directly aligned.

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

5. The vial manipulator of any one of the preceding claims, wherein each of the first and second pivot mechanisms comprises a pivotal attachment of the respective vial holder to the manipulator body, wherein the respective first and second axes pass through the pivotal attachments.

6. The vial manipulator of claim 5, wherein each of the first vial holder and the second vial holder comprises: a pivot plate pivotably connected to a wall of the manipulator body at the pivot attachment; a frame connected to and extending from the pivot plate, the frame being configured to receive and retain the vial assembly; The pivoting of the pivot plate is configured to drive the frame, thereby changing the orientation of the vial assembly held by the frame.

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

8. A vial manipulator according to claim 6 or claim 7, wherein the frame is at least partially open and includes a set of gripping arms extending inside the frame for gripping onto at least a portion of the vial assembly.

9. The vial manipulator of claim 8, wherein the at least portion of the vial assembly comprises a top portion of a vial or an adapter mounted to a top portion of a vial, the gripping arm being shaped to snap fit onto the at least portion of the vial assembly.

10. The vial manipulator of any preceding claim, further comprising a rotation mechanism configured to rotate the manipulator body about the primary axis.

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 of any one of the preceding claims, wherein 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 of claim 12 , wherein the vial assembly held by each of the vial holders is pivotally movable in respective first and second planes, each of the first and second planes intersecting and perpendicular to the first and second axes, respectively, and wherein respective third and fourth axes, each parallel to the primary axis, extend through the first and second planes; whereby in the initial orientation of the vial assembly held by the vial holder, the longitudinal axis of the respective vial assembly is aligned with the third and fourth axes, respectively.

14. The vial manipulator of any preceding claim, wherein each of the first and second pivot mechanisms comprises a respective actuator for enabling pivotal movement of the vial holder.

15. The vial manipulator of claim 14, wherein the actuator is entirely contained within the housing of the manipulator body.

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

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

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

19. The vial manipulator of claim 17, wherein the controller is 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 operating modes: a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial assembly held by the vial holder; b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; as well as c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

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

21. The vial manipulator of claim 19 when dependent on claim 13, and wherein when the controller operates the vial holder according to the agitation mode (a), the vial holder is repeatedly pivoted such that a longitudinal axis of a vial assembly held by the vial holder defines a varying angle of less than 90 degrees relative to opposite sides of the third axis or the fourth axis, respectively, for causing the vial assembly to swing in a pendulum-like motion.

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

23. The vial manipulator of claim 22, wherein the pivotal movement of the vial assembly in the orientation setting mode (b) is configured to flip the vial assembly through an angle of 180 degrees.

24. The vial manipulator of claim 17 when dependent on claim 10, wherein the controller is further configured to control the rotation mechanism to set the rotational position of the first and second vial holders.

25. The vial manipulator of claim 17, wherein the vial manipulator forms part of a robotic drug preparation system, the robotic drug preparation system further comprising 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 of claim 25 , wherein the operating module is a reconstitution / dilution module comprising a fluid insertion component, the vial manipulator being spatially arranged relative to the fluid insertion component such that a respective vial assembly held by one of the first and second vial holders is positioned below the fluid insertion component.

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

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

29. A vial manipulator according to claim 28 when dependent on claim 19, wherein the controller is configured to operate the vial holder according to the fluid communication mode (c) to withdraw fluid via the fluid withdrawal component.

30. The vial manipulator of claim 25, wherein the handling module comprises an articulatable arm, the vial manipulator being spatially positioned such that only one of the first vial holder and the second vial holder is positioned within a reach of the arm, while the other vial holder is outside of the reach.

31. A method of controlling a vial manipulator of a robotic medication preparation system, the vial manipulator comprising a manipulator body and first and second vial holders pivotably connected to the manipulator body, the method comprising: selectively pivoting the first vial holder about a first axis extending outwardly from the manipulator body in a first direction; as well as The second vial holder is selectively pivoted about a second axis extending outwardly from the manipulator body in a second direction different from the first direction.

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

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

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

35. The method of 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 a wall of the manipulator body; and a frame connected to and extending from the pivot plate, the frame being configured to receive and retain the vial assembly; wherein the selective pivoting comprises pivoting the pivot plate while simultaneously moving the frame to change the orientation of the vial assembly retained by the frame.

36. A vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising: a manipulator body defining a primary axis; a first vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; as well as A rotation mechanism is configured to rotate the manipulator body about the main axis.

37. The vial manipulator of claim 36, further comprising: a first pivot mechanism for pivoting the first vial holder about a first axis extending outwardly from the body in a first direction; and a second pivot mechanism for pivoting the second vial holder about a second axis extending outwardly from the body in a second direction.

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

39. The vial manipulator of any one of claims 36 to 38, wherein each of the first vial holder and the second vial holder comprises: a pivot plate pivotably connected to a side wall of the manipulator body; a frame connected to and extending from the pivot plate, the frame being configured to receive and retain the vial assembly; wherein pivoting of the pivot plate moves the frame to at least partially change the orientation of the vial assembly held by the frame.

40. The vial manipulator of claim 36 , wherein the vial assembly held by each of the vial holders is movable in a first plane and a second plane, the first plane and the second plane intersecting the first axis or the second axis, respectively, and a third axis and a fourth axis, both parallel to the major axis, extending through the first plane and the second plane; each of the third axis and the fourth axis being perpendicular to the first axis and the second axis, respectively; whereby in the initial orientation of the vial assembly held by each of the vial holders, the long axis of the vial assembly is aligned with the third axis and the fourth axis, respectively.

41. The vial manipulator of 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 of claim 41 , wherein the actuator is controlled by a controller.

43. The vial manipulator of claim 42, wherein the controller is 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 operating modes: a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial assembly held by the vial holder; b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; as well as c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

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

45. A method of controlling a vial manipulator of a robotic medication preparation system, the vial manipulator comprising a manipulator body having a main axis and first and second vial holders pivotably connected to the manipulator body, the method comprising: receiving corresponding first and second vial assemblies at the first and second vial holders; selectively pivoting at least one of the first vial holder and the second vial holder; as well as The manipulator body is rotated about its primary axis to change the position of the first and second vial holders.

46. ​​The method of claim 45, wherein selectively pivoting comprises repeatedly pivoting the first vial holder to agitate the vial assembly held by the first vial holder while holding the second vial holder stationary.

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

48. The method of claim 45, wherein selectively pivoting comprises pivoting the first vial holder 180 degrees from an initial orientation to hold the first vial assembly in an inverted orientation.

49. The method of claim 48, further comprising aspirating fluid from the first vial assembly held by the first vial holder prior to rotating the manipulator body.

50. A robotic drug preparation system, comprising: A vial manipulator, the vial manipulator comprising: a manipulator body defining a primary axis; a first vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; a second vial holder pivotably coupled to the manipulator body and configured to receive and maintain retention of a vial assembly; and a rotation mechanism configured to rotate the manipulator body about the main axis; and an operating module having an operating area and configured to dock with a vial assembly at the operating area; and a rotation mechanism configured to rotate the manipulator body to move 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 of claim 50, wherein the operation module comprises a fluid insertion component and / or a fluid aspiration component.

52. The system of claim 51, wherein the fluid insertion component and / or fluid aspiration component comprises a syringe.

53. The system of claim 50, wherein the operation module comprises an articulatable arm having a distal end configured to engage a vial assembly.

54. The system of claim 53, wherein the operative region comprises an area within reach of a distal end of the arm.

55. A robotic drug preparation system, comprising: A vial manipulator, the vial manipulator comprising: Manipulator body; a first vial holder configured to receive and maintain retention of a vial assembly, the first vial holder being pivotably coupled to the manipulator body; and a first pivot mechanism configured to pivot the first vial holder; an operating module spatially arranged relative to the first vial holder and configured to hold a fluid communication component for docking with the vial assembly; wherein the first pivot mechanism is configured to pivot the first vial holder to assume the following state: a first state in which the vial assembly held by the first vial holder is in an upright orientation in which fluid communication is established with the fluid communication component for inserting a fluid therethrough; A second state in which the vial assembly held by the first vial holder is in an inverted orientation in which fluid communication is established with the fluid communication component for withdrawing fluid therethrough.

56. The system of claim 55, wherein the fluid communication component comprises a syringe.

57. The system of claim 55 or claim 56, comprising a controller configured to select and operate the first vial holder according to one or more of the following operating modes: (a) an agitation mode in which the vial holder is repeatedly pivoted to mix the contents of the vial assembly; (b) an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of a vial assembly held by the vial holder; as well as (c) a fluid communication mode in which the vial holder remains stable in the first state or the second state.

58. The system of any one of claims 55 to 57, further comprising: a second vial holder configured to receive and maintain retention of a vial assembly, the second vial holder being pivotably coupled to the manipulator body; as well as A second pivot mechanism is configured to pivot the second vial holder.

59. The system of claim 58, further comprising a rotation mechanism configured to rotate the manipulator body about a main axis of the manipulator body to interchange positions of the first and second vial holders.

60. A vial manipulator for use in a robotic medication preparation system, the vial manipulator comprising: a manipulator body defining a primary axis; a first vial holder pivotably coupled to the first face of the manipulator body and configured to receive and maintain retention of a vial assembly; a second vial holder pivotably coupled to the second face of the manipulator body and configured to receive and maintain retention of a vial assembly; as well as a controller 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 operating modes: a. a stirring mode in which the vial holder is repeatedly pivoted for mixing the contents of the vial held by the vial holder; b. an orientation setting mode in which the vial holder is pivoted to set a temporarily fixed orientation of the vial assembly held by the vial holder; as well as c. A fluid communication mode in which the vial holder is held stable in a selected orientation to allow fluid to be inserted into or withdrawn from a vial assembly held by the vial holder.

61. The vial manipulator of claim 60, wherein two or more of the operating modes can be performed sequentially without removing the vial assembly from the vial holder.

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

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