Syringe-optimized robotic pharmaceutical preparation

Abstract

Image-guided syringe-manipulation subsystem of a pharmaceutical preparation system (PPS). Syringes are engaged by a gripper and a plunger arm, allowing movement of the syringe plunger by relative movement of the gripper and plunger arm. Processing circuitry accesses one or more images of the syringe to determine one or more of its characteristics (e.g., its type and / or geometric measurements). The value of least one operating parameter which controls how the syringe is manipulated is then determined according to the determined one or more characteristics.

Description

[0001] SYRINGE-OPTIMIZED ROBOTIC PHARMACEUTICAL PREPARATION

[0002] RELATED APPLICATIONS

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 445,370 filed on February 14, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The presently disclosed subject matter relates to the field of robotic preparation of pharmaceuticals, and in more particularly, but not exclusively, to operations involving manipulation of fluid transfer units such as syringes.

[0006] Problems of implementation of automation of pharmaceutical preparation have been recognized in the conventional art, and various techniques have been developed to provide solutions.

[0007] SUMMARY OF THE INVENTION

[0008] According to an aspect of some examples of the present disclosure, there is provided a fluid transfer assembly-manipulation subsystem of a pharmaceutical preparation system (PPS), the subsystem including: a gripper, configured to grip a fluid transfer assembly; a fluid pump, which operates to urge transfer of fluid into or out of the fluid transfer assembly according to a pressure exerted by the fluid pump, while the fluid transfer assembly is gripped by the gripper; and processing circuitry including a processor and memory, the memory storing instructions which instruct the processor to: access at least one image of the fluid transfer assembly; process the image to determine at least one characteristic of the fluid transfer assembly, and command at least one of the gripper and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one respective operating parameter; wherein the at least one value of the at least one respective operating parameter is selected according to the determined at least one characteristic.

[0009] According to some examples of the present disclosure, the fluid transfer assemblymanipulation subsystem includes at least one imager positioned to image the fluid transfer assembly while the gripper is engaged with the fluid transfer assembly; and the at least one image of the fluid transfer assembly is imaged by the at least one imager. According to some examples of the present disclosure, the fluid transfer assemblymanipulation subsystem includes an illumination source which lights the fluid transfer assembly from an angle adjustable among images while the at least one imager images the at least one image of the fluid transfer assembly.

[0010] According to some examples of the present disclosure, the fluid transfer assemblymanipulation subsystem includes an illumination source which illuminates the fluid transfer assembly with structured light while the at least one imager images the at least one image of the fluid transfer assembly.

[0011] According to some examples of the present disclosure, the at least one imager images the fluid transfer assembly in at least two different positions to produce the at least one image.

[0012] According to some examples of the present disclosure, the at least one imager images the fluid transfer assembly from at least two different positions to produce the at least one image.

[0013] According to some examples of the present disclosure, at least one image includes a plurality of images, and the processing circuitry uses a differential image produced using the plurality of images to determine the at least one characteristic of the fluid transfer assembly.

[0014] According to some examples of the present disclosure, the fluid transfer assemblymanipulation subsystem includes an illumination source which back-lights the fluid transfer assembly from the perspective of the at least one imager while the at least one imager images the at least one image of the fluid transfer assembly.

[0015] According to some examples of the present disclosure, when processing the image, the processing circuitry: uses the at least one image to determine a type of the fluid transfer assembly; selects fluid transfer assembly model data, using the type; and uses the selected fluid transfer assembly model data to determine the at least one characteristic.

[0016] According to some examples of the present disclosure, when processing the image, the processing circuitry determines the type using machine learning-based classification of the image.

[0017] According to some examples of the present disclosure, when processing the image, the processing circuitry determines the type using at least one of a fluid transfer assembly diameter and a fluid transfer assembly length determined using the at least one image.

[0018] According to some examples of the present disclosure, when processing the image, the processing circuitry determines the type using an appearance in the at least one image of at least one of: scale markings on the fluid transfer assembly, logo markings on the fluid transfer assembly, and a pattern marked on the fluid transfer assembly encoding a digital value. According to some examples of the present disclosure, when processing the image, the processing circuitry determines the type using a geometrical shape appearing in the at least one image including at least one of: a shape of a piston of the fluid transfer assembly, a shape of a shaft of the fluid transfer assembly, a shape of an apex of a body of a fluid transfer unit of the fluid transfer assembly, and a shape of a flange of the body.

[0019] According to some examples of the present disclosure, when processing the image, the processing circuitry: uses the at least one image to measure a geometry of the fluid transfer assembly; generates fluid transfer assembly model data, using the measured geometry; and uses the generated fluid transfer assembly model data to determine the at least one characteristic.

[0020] According to some examples of the present disclosure, when processing the image, the processing circuitry determines the at least one value according to a table indexed by the fluid transfer assembly model data.

[0021] According to some examples of the present disclosure, when processing the image, the processing circuitry determines the at least one value according to machine learning classification of the fluid transfer assembly model data.

[0022] According to some examples of the present disclosure, the at least one characteristic includes a diameter of the fluid transfer assembly, and the at least one operating parameter includes a corresponding gripping diameter of the gripper.

[0023] According to some examples of the present disclosure, the at least one characteristic includes a shape of the fluid transfer assembly; and the at least one operating parameter includes a respective targeted gripping position for the gripper along the fluid transfer assembly.

[0024] According to some examples of the present disclosure, the at least one characteristic includes a designated gripping location of the fluid transfer assembly; and the at least one operating parameter includes a gripping position of the fluid transfer assembly targeting the designated gripping location.

[0025] According to some examples of the present disclosure, the fluid pump includes a plunger arm, configured to move a plunger of the fluid transfer assembly while gripped.

[0026] According to some examples of the present disclosure, the at least one characteristic includes a relative position of a body of a fluid transfer unit of the fluid transfer assembly and the plunger; and the processor is instructed to use the relative position in at least one of: controlling transfer of a fluid using the fluid transfer assembly, and verifying the transfer.

[0027] According to some examples of the present disclosure, the at least one operating parameter includes a targeted connecting position of the plunger arm to the plunger. According to some examples of the present disclosure, the at least one operating parameter includes a targeted linear distance moved by the plunger while connected to the plunger arm, the targeted linear distance being determined in accordance with a targeted volume of the fluid to be transferred.

[0028] According to some examples of the present disclosure, the at least one characteristic includes a constraining range of allowed relative positions of a body of a fluid transfer unit of the fluid transfer assembly and the plunger, selected to be consistent with an available range of motion of the plunger relative to the body; and the instructions instruct the processor to: access a targeted linear distance of movement of the plunger relative to the body; and determine a status indicating whether the targeted linear distance of movement is consistent with both: the relative position of the body and the plunger, and the constraining range of allowed relative positions of the body and the plunger.

[0029] According to some examples of the present disclosure, when the status indicates inconsistency, the processor is instructed to perform at least one of: abort manipulation of the fluid transfer assembly, reduce the targeted linear distance, and adjust a plan for pharmaceutical preparation with respect to manipulation of an additional fluid transfer assembly.

[0030] According to some examples of the present disclosure, the at least one characteristic determined from the at least one image of the fluid transfer assembly includes a resistance to flow associated with the fluid transfer assembly; and the instructions instruct the processor to: access a value indicative of a viscosity of a fluid being transferred using the fluid transfer assembly; and determine a targeted velocity of linear movement of the plunger relative to a body of a fluid transfer unit of the fluid transfer assembly; wherein the targeted velocity is determined in accordance with the value indicative of the viscosity of the fluid and the resistance to flow of the fluid transfer assembly, and in accordance with an upper limit on pressures generated within the fluid transfer assembly during the linear movement of the plunger.

[0031] According to some examples of the present disclosure, the at least one characteristic includes an upper pressure rating of the fluid transfer assembly, and the upper limit on pressures is determined according to the upper pressure rating.

[0032] According to some examples of the present disclosure, the at least one characteristic includes a targeted operating pressure of the fluid transfer assembly, and the targeted velocity of linear movement of the fluid transfer assembly is determined according to the targeted operating pressure. According to some examples of the present disclosure, the instructions instruct the processor to access a vapor pressure of the fluid being transferred using the fluid transfer assembly; and the targeted velocity is further determined in accordance with the vapor pressure of the fluid, in accordance with lower limit on pressures generated within the fluid transfer assembly during the linear movement of the plunger.

[0033] According to some examples of the present disclosure, the fluid transfer assemblymanipulation subsystem includes a fluid transfer assembly transporter configured to engage fluid transfer assemblies with the fluid transfer assembly-manipulation subsystem.

[0034] According to some examples of the present disclosure, the fluid transfer assemblymanipulation subsystem includes a vial holder configured to position vials at one or more locations accessible to interconnection of held vials with fluid transfer assemblies manipulated by the fluid transfer assembly-manipulation subsystem.

[0035] According to some examples of the present disclosure, the at least one image includes at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly by the fluid transfer assembly-manipulation subsystem; and the processor adjusts the at least one operating parameter from an initial value to an adjusted value based on the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly.

[0036] According to some examples of the present disclosure, the processing circuitry scans the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly for detection of one or more adverse conditions; and upon detection, produces a signal indicative of the one or more adverse conditions.

[0037] According to some examples of the present disclosure, the one or more adverse conditions scanned for comprise at least one of: rotation of a body of a fluid transfer unit of the fluid transfer assembly; movement of the body along a longitudinal axis of the body, a change in shape of the body, and a change in shape of a plunger of the fluid transfer unit.

[0038] According to some examples of the present disclosure, the one or more adverse conditions scanned for comprise at least one of the changes in shape, determined using comparison of the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly with a baseline image.

[0039] According to some examples of the present disclosure, the fluid transfer assembly includes a fluid transfer connector attached to a fluid transfer unit during movement of a plunger of the fluid transfer unit, and the one or more adverse conditions scanned for comprise at least one of: an incorrect amount of visible length of a portion of a body of the fluid transfer unit; an incorrect distance of a portion of the body from a portion of the fluid transfer connector, a relative movement of the body and the fluid transfer connector, and fluid leakage in associated with a junction between the body and the fluid transfer connector.

[0040] According to some examples of the present disclosure, the PPS produces an alert upon receiving the signal.

[0041] According to some examples of the present disclosure, the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly by the fluid transfer assembly-manipulation subsystem indicates a linear velocity of a plunger different than a targeted velocity of the plunger.

[0042] According to an aspect of some examples of the present disclosure, there is provided a method of configuring a fluid transfer assembly-manipulation subsystem of a pharmaceutical preparation system (PPS), the fluid transfer assembly-manipulation subsystem including a gripper, configured to grip the fluid transfer assembly, and a fluid pump which operates to urge transfer of fluid into or out of the fluid transfer assembly according to a pressure exerted by the pump, while the fluid transfer assembly is gripped; and wherein the method includes: determining, by processing circuitry, at least one characteristic of the fluid transfer assembly, using at least one image of the fluid transfer assembly; and commanding at least one of the gripper and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one respective operating parameter; wherein the at least one value of the at least one respective operating parameter is selected according to the determined at least one characteristic.

[0043] According to some examples of the present disclosure, the method includes acquiring the image using an imager.

[0044] According to some examples of the present disclosure, the method includes: determining a type of the fluid transfer assembly, using the at least one image; selecting fluid transfer assembly model data, using the type; and using the selected fluid transfer assembly model data to determine the at least one characteristic.

[0045] According to some examples of the present disclosure, the determining the type includes measuring at least one of a fluid transfer assembly diameter and a fluid transfer assembly length using the least one image.

[0046] According to some examples of the present disclosure, the determining uses an appearance in the at least one image of at least one of: scale markings on the fluid transfer assembly, logo markings on the fluid transfer assembly, and a pattern marked on the fluid transfer assembly encoding a digital value. According to some examples of the present disclosure, the determining uses a geometrical shape appearing in the at least one image including at least one of: a shape of a piston of the fluid transfer assembly, a shape of a shaft of the fluid transfer assembly, a shape of an apex of a body of a fluid transfer unit of the fluid transfer assembly, and a shape of a flange of the body.

[0047] According to some examples of the present disclosure, the determining at least one characteristic includes: measuring a geometry of the fluid transfer assembly using the at least one image; generating fluid transfer assembly model data, using the measured geometry; and using the generated fluid transfer assembly model data to determine the at least one characteristic.

[0048] According to some examples of the present disclosure, the fluid pump includes a plunger arm, and the commanding commands movement of a plunger of the fluid transfer assembly while gripped.

[0049] According to some examples of the present disclosure, the at least one characteristic includes a relative position of a body of a fluid transfer unit of the fluid transfer assembly and the plunger; and including using the relative position in at least one of: controlling transfer of a fluid using the fluid transfer assembly, and verifying the transfer.

[0050] According to some examples of the present disclosure, the at least one characteristic includes a constraining range of allowed relative positions of a body of a fluid transfer unit of the fluid transfer assembly and the plunger, selected to be consistent with an available range of motion of the plunger relative to the body; and the method includes: accessing a targeted linear distance of movement of the plunger relative to the body; and determining a status indicating whether the targeted linear distance of movement is consistent with both: the relative position of the body and the plunger, and the constraining range of allowed relative positions of the body and the plunger.

[0051] According to some examples of the present disclosure, the at least one characteristic determined from the at least one image of the fluid transfer assembly includes a resistance to flow associated with the fluid transfer assembly; and the method includes: accessing a value indicative of a viscosity of a fluid being transferred using the fluid transfer assembly; and determining a targeted velocity of linear movement of the plunger relative to a body of a fluid transfer unit of the fluid transfer assembly, the determining being: in accordance with the value indicative of the viscosity of the fluid and the resistance to flow of the fluid transfer assembly, and in accordance with an upper limit on pressures generated within the fluid transfer assembly during the linear movement of the plunger. According to an aspect of some examples of the present disclosure, there is provided a computer program product including a computer-readable non-transitory storage medium containing program instructions, which the program instructions, when read by a processor, cause the processing circuitry to perform a method of configuring fluid transfer assembly manipulation in a pharmaceutical preparation system (PPS), the fluid transfer assemblymanipulation subsystem including a gripper configured to grip the fluid transfer assembly, and a fluid pump which operates to urge transfer of fluid into or out of the fluid transfer assembly according to a pressure exerted by the fluid pump, while the fluid transfer assembly is gripped; and wherein the method includes: determining, by processing circuitry, at least one characteristic of the fluid transfer assembly, using an image of the fluid transfer assembly; and commanding at least one of the gripper and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one respective operating parameter; wherein the at least one value of the at least one respective operating parameter is selected according to the determined at least one characteristic.

[0052] According to an aspect of some examples of the present disclosure, there is provided a system of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the system including a processing circuitry operably connected to a camera and a gripper, and configured to: i) receive a digital image of a syringe; ii) determine syringe model data, from the digital image, using image processing techniques; and iii) control the gripper to grip the syringe with a determined gripping diameter, the determined gripping diameter being in accordance with the syringe model data.

[0053] According to some examples of the present disclosure, the determining syringe model data includes machine-leaming-based classification of the received image.

[0054] According to some examples of the present disclosure, the processing circuitry is further configured to determine the gripping diameter from a table indexed by the syringe model data.

[0055] According to some examples of the present disclosure, the processing circuitry is further configured to determine the gripping diameter by machine learning classification of the syringe model data.

[0056] According to an aspect of some examples of the present disclosure, there is provided a system of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the system including a processing circuitry operably connected to a camera and a gripper, the processing circuitry being configured to: i) receive a digital image of a syringe; ii) determine syringe model data, from the digital image, using image processing techniques; and iii) control the gripper to grip the syringe barrel at a determined gripping location, the determined gripping location being in accordance with the syringe model data.

[0057] According to some examples of the present disclosure, the determining syringe model data includes machine-leaming-based classification of the received image.

[0058] According to some examples of the present disclosure, the processing circuitry is further configured to determine the gripping location from a table indexed by the syringe model data.

[0059] According to some examples of the present disclosure, the processing circuitry is further configured to determine the gripping location by machine learning classification of the syringe model data.

[0060] According to an aspect of some examples of the present disclosure, there is provided a system of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the system including a processing circuitry operably connected to a camera and a syringe plunger arm, the processing circuitry including a processor and memory, the processing circuitry being configured to: i) receive a digital image of a syringe; ii) determine syringe model data, from the digital image, using image processing techniques; and iii) control the syringe plunger arm to move the syringe plunger a determined linear distance, the determined linear distance being in accordance with, at least: i. a volume of a fluid for transfer, and ii. the syringe model data.

[0061] According to some examples of the present disclosure, the determining syringe model data includes machine-leaming-based classification of the received image.

[0062] According to an aspect of some examples of the present disclosure, there is provided a system of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the system including a processing circuitry operably connected to a camera and a syringe plunger arm, the processing circuitry being configured to: i) receive a digital image of a syringe; ii) determine syringe model data, from the digital image, using image processing techniques; and iii) control the syringe plunger arm to move a syringe plunger with a determined velocity, the determined velocity being associated with the syringe model.

[0063] According to some examples of the present disclosure, the determined velocity is in further accordance with a viscosity of the fluid for transfer.

[0064] According to some examples of the present disclosure, the determining syringe model data includes machine-leaming-based classification of the received image.

[0065] According to some examples of the present disclosure, the processing circuitry is further configured to determine the gripping location from a table indexed by the syringe model data. According to some examples of the present disclosure, the processing circuitry is further configured to determine the gripping location by machine learning classification of the syringe model data.

[0066] According to an aspect of some examples of the present disclosure, there is provided a system of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the system including a processing circuitry operably connected to a camera, the processing circuitry being configured to: i) receive a digital image of a syringe; ii) determine syringe model data, from the digital image, using image processing techniques; iii) determine, from the digital image, a length of an exposed portion of a cannula of the syringe, wherein the exposed portion is beneath a syringe connector; iv) compare the determined length of the exposed portion to a threshold length, wherein the threshold length is in accordance with the syringe model data, thereby giving rise to data indicative of whether the syringe connector is correctly attached to the syringe; and v) responsive to the syringe connector not being correctly attached to the syringe, raise an alert.

[0067] According to an aspect of some examples of the present disclosure, there is provided a processing circuitry-based method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the processing circuitry being operably connected to a camera and a gripper, and the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling the gripper to grip the syringe with a determined gripping diameter, the determined gripping diameter being in accordance with the syringe model data.

[0068] According to an aspect of some examples of the present disclosure, there is provided a processing circuitry-based method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the processing circuitry being operably connected to a camera and a gripper, and the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling the gripper to grip the syringe barrel at a determined gripping location, the determined gripping location being in accordance with the syringe model data.

[0069] According to an aspect of some examples of the present disclosure, there is provided a processing circuitry-based method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the processing circuitry being operably connected to a camera and a syringe plunger arm, and the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling the syringe plunger arm to move the syringe plunger a determined linear distance, the determined linear distance being in accordance with, at least: i. a volume of a fluid for transfer, and ii. the syringe model data.

[0070] According to an aspect of some examples of the present disclosure, there is provided a processing circuitry-based method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the processing circuitry being operably connected to a camera and a syringe plunger arm, and the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling the syringe plunger arm to move a syringe plunger with a determined velocity, the determined velocity being associated with the syringe model.

[0071] According to an aspect of some examples of the present disclosure, there is provided a processing circuitry-based method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the processing circuitry being operably connected to a camera, the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; iii) determining, from the digital image, a length of an exposed portion of a cannula of the syringe, wherein the exposed portion is beneath a syringe connector; iv) comparing the determined length of the exposed portion to a threshold length, wherein the threshold length is in accordance with the syringe model data, thereby giving rise to data indicative of whether the syringe connector is correctly attached to the syringe; and v) responsive to the syringe connector not being correctly attached to the syringe, raising an alert.

[0072] According to an aspect of some examples of the present disclosure, there is provided a computer program product including a computer readable non-transitory storage medium containing program instructions, which program instructions when read by a processor, cause the processing circuitry to perform a method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling a gripper to grip the syringe with a determined gripping diameter, the determined gripping diameter being in accordance with the syringe model data.

[0073] According to an aspect of some examples of the present disclosure, there is provided a computer program product including a computer readable non-transitory storage medium containing program instructions, which program instructions when read by a processor, cause the processing circuitry to perform a method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling a gripper to grip the syringe at a determined gripping location, the determined gripping location being in accordance with the syringe model data.

[0074] According to an aspect of some examples of the present disclosure, there is provided a computer program product including a computer readable non-transitory storage medium containing program instructions, which program instructions when read by a processor, cause the processing circuitry to perform a method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling the syringe plunger arm to move a plunger of the syringe by a determined linear distance, the determined linear distance being in accordance with, at least: i. a volume of a fluid for transfer, and ii. the syringe model data.

[0075] According to an aspect of some examples of the present disclosure, there is provided a computer program product including a computer readable non-transitory storage medium containing program instructions, which program instructions when read by a processor, cause the processing circuitry to perform a method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; and iii) controlling the syringe plunger arm to move a syringe plunger with a determined velocity, the determined velocity being associated with the syringe model.

[0076] According to an aspect of some examples of the present disclosure, there is provided a computer program product including a computer readable non-transitory storage medium containing program instructions, which program instructions when read by a processor, cause the processing circuitry to perform a method of optimizing handling of a syringe in a pharmaceutical preparation system (PPS), the method including: i) receiving a digital image of a syringe; ii) determining syringe model data, from the digital image, using image processing techniques; iii) determining, from the digital image, a length of an exposed portion of a cannula of the syringe, wherein the exposed portion is beneath a syringe connector; iv) comparing the determined length of the exposed portion to a threshold length, wherein the threshold length is in accordance with the syringe model data, thereby giving rise to data indicative of whether the syringe connector is correctly attached to the syringe; and v) responsive to the syringe connector not being correctly attached to the syringe, raising an alert.

[0077] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, controls. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0078] As will be appreciated by one skilled in the art, aspects of the present disclosure may be embodied as a system, method, or computer program product. Accordingly, aspects of the present disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system” (e.g., a method may be implemented using “computer circuitry”). Furthermore, some embodiments of the present disclosure may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and / or system of some embodiments of the present disclosure can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and / or system of the present disclosure, several selected tasks could be implemented by hardware, by software or by firmware and / or by a combination thereof, e.g., using an operating system.

[0079] For example, hardware for performing selected tasks according to some embodiments of the present disclosure could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the present disclosure could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In some embodiments of the present disclosure, one or more tasks performed in method and / or by system are performed by a data processor (also referred to herein as a “digital processor”, in reference to data processors which operate using groups of digital bits), such as a computing platform for executing a plurality of instructions. Instruction executing elements of the processor may comprise, for example, one or more microprocessor chips, ASICs, and / or FPGAs. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is provided as well. A display and / or a user input device such as a keyboard or mouse are optionally provided as well. Any of these implementations are referred to herein more generally as instances of computer circuitry. Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the present disclosure. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device. A computer readable storage medium may also contain or store information for use by such a program, for example, data structured in the way it is recorded by the computer readable storage medium so that a computer program can access it as, for example, one or more tables, lists, arrays, data trees, and / or another data structure. Herein a computer readable storage medium which records data in a form retrievable as groups of digital bits is also referred to as a digital memory. It should be understood that a computer readable storage medium, in some embodiments, is optionally also used as a computer writable storage medium, in the case of a computer readable storage medium which is not read-only in nature, and / or in a read-only state.

[0080] Herein, a data processor is said to be “configured” to perform data processing actions insofar as it is coupled to a computer readable medium to receive instructions and / or data therefrom, process them, and / or store processing results in the same or another computer readable medium. The processing performed (optionally on the data) is specified by the instructions, with the effect that the processor operates according to the instructions. The act of processing may be referred to additionally or alternatively by one or more other terms; for example: comparing, estimating, determining, calculating, identifying, associating, storing, analyzing, selecting, and / or transforming. For example, in some embodiments, a digital processor receives instructions and data from a digital memory, processes the data according to the instructions, and / or stores processing results in the digital memory. In some embodiments, “providing” processing results comprises one or more of transmitting, storing and / or presenting processing results. Presenting optionally comprises showing on a display, indicating by sound, printing on a printout, or otherwise giving results in a form accessible to human sensory capabilities.

[0081] A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0082] Program code embodied on a computer readable medium and / or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0083] Computer program code for carrying out operations for some embodiments of the present disclosure may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the “C” programming language or similar programming languages. Additionally or alternatively, sequences of logical operations (optionally logical operations corresponding to computer instructions) may be embedded in the design of an ASIC and / or in the configuration of an FPGA device. The program code may execute entirely on the user’s computer, partly on the user’s computer (e.g., as a stand-alone software package), partly on the user’s computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user’s computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0084] Some embodiments of the present disclosure may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the present disclosure. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0085] These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function / act specified in the flowchart and / or block diagram block or blocks.

[0086] The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0087] Some of the methods described herein are generally designed only for use by a computer; and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such inspecting obj ects, might be expected to use completely different methods, e.g., making use of expert knowledge and / or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

[0088] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0089] Some embodiments of the present disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example, and for purposes of illustrative discussion of embodiments of the present disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

[0090] In the drawings:

[0091] Fig. 1A illustrates elements of an example pharmaceutical preparation system (PPS) with image-guided syringe type- and / or geometry-based process control, according to some embodiments of the present disclosure;

[0092] Fig. IB is a schematic flow diagram of a method of image-guided control of a syringe manipulation process, according to some embodiments of the present disclosure; Figs. 2A-2C illustrate elements of an example pharmaceutical preparation system (PPS), according to some embodiments of the present disclosure;

[0093] Fig. 2D schematically illustrates a syringe assembly, according to some embodiments of the present disclosure;

[0094] Figs. 2E-2F schematically illustrate an example of a syringe transport unit, according to some embodiments of the present disclosure;

[0095] Figs. 2G-2H illustrate (using top views) an example of a gripper, according to some embodiments of the present disclosure;

[0096] Figs. 2I-2J illustrate (in top views) imaging of syringe transport unit, according to some embodiments of the present disclosure;

[0097] Fig. 3A illustrates a detailed block diagram of an example syringe manipulation subsystem, with example interfaces to a gripper and to a plunger arm, according to some embodiments of the present disclosure;

[0098] Fig. 3B schematically illustrates imaging and image processing elements of a PPS, according to some embodiments of the present disclosure;

[0099] Fig. 4A illustrates a flow diagram of an example method of gripping a syringe by a gripper, the gripping being optimized for determined syringe type data, according to some embodiments of the present disclosure;

[0100] Fig. 4B illustrates a flow diagram of an example method of drawing fluid into a syringe or injecting fluid from a syringe, the drawing or injecting being selected according to one or more determined syringe characteristics, according to some embodiments of the present disclosure; and

[0101] Fig. 4C illustrates a flow diagram of an example method of determining whether a syringe connector is correctly attached to a syringe, utilizing one or more determined syringe characteristics, according to some embodiments of the present disclosure.

[0102] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0103] The presently disclosed subject matter relates to the field of robotic preparation of pharmaceuticals, and in more particularly, but not exclusively, to operations involving manipulation of fluid transfer units such as syringes.

[0104] Overview

[0105] An aspect of some examples of the present disclosure relates to pharmaceutical preparation systems (PPS) which use fluid transfer assemblies to transfer fluids (including pharmaceutical-containing fluids and / or other fluids) among containers in order to create a compounded pharmaceutical suitable to a particular treatment requirement. In some examples, the containers include vials (e.g., vials in which pharmaceutical material is stored), from which fluid is to be withdrawn, and intravenous bags (IV bags), in which pharmaceutical material is to be mixed prior to administration to a patient.

[0106] Given the medical setting in which such systems operate, there are potentially strict performance requirements imposed upon their acceptance for use; e.g., performance requirements for accuracy, speed, and reliability. Pharmaceuticals may comprise radioactive compounds, for example, such that great care should be taken to avoid leakage and consequent contamination of the preparation environment. The pharmaceutical preparations themselves should be prepared reliably, e.g., with neither more nor less active compound than has been prescribed for a patient.

[0107] However, there are potentially dynamic and / or uncertain aspects to the functioning of such systems and / or their operating environment. For example, there may be a variety of fluid transfer assembly types useable with a given system, and / or the fluid transfer assemblies available, even if of the same type (e.g., same manufacturer and model) may be subject to a certain degree of manufacturing variability (e.g., batch variability). Pharmaceuticals themselves may be provided in formulations having different properties; in particular, viscosity may be different among different preparations. Furthermore, human error may be a factor in system configuration.

[0108] In some examples of the present disclosure, images of fluid transfer assemblies are obtained at one or more stages of fluid transfer assembly use during pharmaceutical preparation, and subjected to image processing. Results of the image processing are used to determine characteristics of the fluid transfer assemblies. In particular, certain fluid transfer assembly characteristics may be relevant to the selection of values governing parameters of the manipulation of a fluid transfer assembly.

[0109] In particular, a fluid transfer assembly’s geometry (e.g., its length and / or diameter) influences how it should be engaged with by the robotic device which will manipulate it. In some examples, these characteristics are optionally determined and / or verified by direct measurements made from images of a fluid transfer assembly. This potentially mitigates a risk condition wherein an incorrectly sized and / or configured fluid transfer assembly is inadvertently and / or unexpectedly placed in a fluid transfer assembly depot. Additionally or alternatively, in some examples, fluid transfer assembly characteristics are stored by type (e.g., as fluid transfer assembly type data), and image processing used to detect identifying features of a fluid transfer assembly which are not necessarily directly related to its geometry. These features may comprise identifiers explicitly provided for the purpose of automated identification such as bar codes, QR codes, or another imaged pattern. Additionally or alternatively, identifying features may comprise elements placed on the fluid transfer unit and / or fluid transfer connector for another primary purpose, e.g., scale marking, manufacturer’s logo, or another purpose. Additionally or alternatively, aspects of the shape of a fluid transfer assembly may be identifying which are not themselves direct indications of a fluid transfer assembly’s characteristics which are functionally relevant to selection of parameter values for fluid transfer assembly manipulation.

[0110] Scenarios for use of images in fluid transfer assembly manipulation include determining how a fluid transfer assembly transporter should be moved to engage with it — e.g., where and / or with what diameter to grip its body and / or fluid transfer connector; and / or where and / or with what manipulator (or portion thereof) to engage with its plunger. For example, and even for a set of fluid transfer assemblies all of a given type, there may be differences in the relative placement of the fluid transfer unit plunger. In some examples of the present disclosure, fluid transfer assemblies are imaged during the process of fluid transfer assembly engagement, to select and / or verify values of motion and / or positioning parameters which should be used by the fluid transfer assembly transporter and its various actuators.

[0111] Another scenario for use of images in fluid transfer assembly manipulation is in selecting how a fluid transfer assembly should be manipulated for the withdrawal of fluids (e.g., from a vial) and / or the injection of fluids (e.g., to an IV bag). There is potentially a premium placed on performing these manipulations quickly, e.g., to make efficient use of the PPS and / or personnel and / or resources which support its use. However, overly fast operation may lead to failure conditions of various sorts, e.g., leakage and / or damage due to overpressurization of a fluid in a fluid transfer unit. During withdrawal of fluid, overly-rapid application of suction could potentially lead to a low enough vapor pressure to produce undesirable bubbles. In some examples of the present disclosure, fluid transfer assembly characteristics determined from images are used to help select a targeted velocity at which a fluid transfer unit plunger is operated. In some examples of the present disclosure, system behavior during fluid transfer assembly manipulation is itself imaged to determine one or more characteristics of the currently manipulated fluid transfer assembly (e.g., characteristics which exist jointly according to a fluid with which the fluid transfer assembly is interacting). These characteristics may be used to adjust how a fluid transfer unit plunger is operated. Another scenario for use of images in fluid transfer assembly manipulation is in verifying that the fluid transfer unit and / or a fluid transfer assembly of which the fluid transfer unit is a component is correctly configured. For example, the fluid transfer assembly may also comprise a fluid transfer connector to which the fluid transfer unit is connected. An incorrect attachment carries with it the potential for a fault such as fluid leakage. In some examples, a geometric feature of the fluid transfer unit and / or fluid transfer assembly is imaged and measured to verify that it is in a correct condition for use. For example, relative positions of assembly components may be measured, such as protruding length of a certain section of cannula which is attached to the fluid transfer unit, but protrudes past a fluid transfer connector which is potentially not fully attached. In the case that the fluid transfer connector is not fully attached, the protruding length may not match a certain criterion such as a threshold value for its length. In another example of this scenario type, a fluid transfer unit plunger is potentially not in a correct position to allow a full range of movement which would be required in order to inject / withdraw a targeted volume of fluid. In some examples, images of the fluid transfer unit are evaluated to ensure that the plunger’s present position is consistent with the requirements for its manipulation about to be performed.

[0112] Another scenario for use of images in fluid transfer assembly manipulation is in verifying that the fluid transfer assembly remains within acceptable parameters for use with respect to any distortions of its shape which may arise during operation. Extreme distortions may be indicative of failure; however, there may be normal (albeit small) levels of distortion which are acceptable and / or expected. In some examples of the present disclosure, fluid transfer assemblies are imaged during manipulation, and the images used to assess a level of geometrical distortion which the fluid transfer assembly is undergoing.

[0113] In cases (e.g., of any of the above scenarios) where a type of fault or mismatch in actual vs. expected is discovered and / or determined to be incipient, a PPS optionally responds by any one or more of: adjustment to fluid transfer assembly manipulation, abandonment of use of the current fluid transfer assembly, adjustment of preparation which incorporates use of another fluid transfer assembly, and / or raising of an alert. The alert may be of any suitable form — e.g., auditory, visual, local, and / or remote (e.g., an alert transmitted to a remote station).

[0114] Term Definitions

[0115] Subject matter of the present disclosure generally relates to robotic pharmaceutical preparation systems, and more particularly to fluid transfer stations within a robotic pharmaceutical preparation system. It is to be understood that, for brevity and clarity, examples described herein (with reference to the drawings and otherwise) are described with reference to component subsets of pharmaceutical preparation systems; e.g., particular aspects of the overall fluid transfer apparatus assembly. Furthermore, embodiments straightforwardly analogous to examples described herein should be understood as being encompassed within the scope of the present disclosure. This includes, for example, particular implementations and / or combinations of elements and / or subsystems different in detail than explicitly described, but alike in function and / or functional role.

[0116] Pharmaceutical preparation systems: Embodiments of robotic pharmaceutical preparation systems and the fluid transfer stations thereof described herein are configured for performing operations related to transfer of pharmaceuticals between different fluid transfer apparatuses.

[0117] Robotic pharmaceutical preparation systems (which may alternatively be referred to as “robotic systems”) according with the subject matter of the present disclosure include elements and / or subsystems such as robotic stations, robotic arms, motors, control units, and / or other mechanisms which operate to perform, control, and / or verify fluid transfer. These elements are optionally designed and / or described as making up and / or made up of units and / or subsystems operable for performing activities related to preparation of pharmaceuticals designated for administration to patients. For example, a robotic system may comprise one or more automatic or partially automatic subsystems comprising at least one manipulator controlled at least partially by a controller unit (equivalently referred to as controller or control unit). Controller units may themselves be arranged in communication with each other, e.g., hierarchically, and / or in a network, in order to coordinate overall functioning of the pharmaceutical preparation system.

[0118] Pharmaceutical preparation system described herein perform fluid transfer between fluid transfer apparatuses designated containers and fluid transfer units, with the latter often acting as the intermediate element (typically but not necessarily also the “active” element, e.g., the element through which pressure is generated which results in fluid movement), and the former being considered as the fluid source or fluid receiving element (typically but not necessarily a “passive” element). The fluid transfer may be assisted by a fluid transfer connector. However, an ordinarily intermediate fluid transfer unit may nevertheless optionally operate as an initial source of a fluid (e.g, in the form of a pre-filled syringe provided at the beginning of pharmaceutical preparation), and / or as a final receptacle for fluid (e.g, in the form of a filled unit which passes onward to another process such as delivery to a patient, storage, or another purpose). Nor is it excluded that a container takes on an intermediate role as both a fluid source and as a fluid receiver.

[0119] Embodiments of transfer apparatuses may comprise, for example, one or more conduits, pumps, syringes, vials, intravenous bags, adaptors, and / or needles. Optionally, these elements are consumables and / or accessories of the pharmaceutical preparation systems. Optionally, such elements are nevertheless considered as pharmaceutical preparation system components.

[0120] Fluid: As referred to herein, “fluid” typically comprises a pharmaceutical, a diluent, saline solution, water, or any other fluid used in pharmaceutical preparation.

[0121] Fluid transfer: “Fluid transfer” is performed in between a container assembly and a fluid transfer assembly via openings formed in a port of the container assembly or fluid transfer assembly and / or via openings formed in a septum of the container assembly or fluid transfer assembly.

[0122] Fluid transfer unit: Herein a “fluid transfer unit” comprises a fluid-accepting device which operates and / or can be operated to take in fluid (e.g, from a first container), and to expel fluid (e.g, into a second container). It may be implemented, for example, using a syringe other fluid reservoir, optionally incorporating appropriate connecting tubing, and may further comprise elements such as a fluid transfer conduit, and a body (which holds fluid contents). For the sake of avoiding waste of fluid being transferred, a syringe interconnecting to other containers through a narrow cannula (e.g., a needle or other metal tube with a diameter of, e.g., 1 mm or less) has a potential advantage of a relatively low dead volume, e.g., compared to implementations in which transfer from a primary reservoir of fluid using a length of relatively wide inner-diameter flexible tubing In the case of a syringe, for example, the body may be understood as comprising the barrel of the syringe. A fluid transfer unit may comprise a plunger or other element which moves to urge the movement of fluid into or out of the body of the fluid transfer unit. A fluid transfer unit may itself constitute a fluid transfer assembly, or it may be joined to another element such as a fluid transfer connector to form one. A fluid transfer unit is typically involved in the originating of pressure gradients which induce fluid transfer; i.e., its contents and / or its content-receiving compartment undergoes a change in pressure which induces a corresponding change in pressure in a container to which it is coupled, and corresponding transfer of fluid.

[0123] Fluid transfer connector: In some examples, a fluid transfer assembly includes a “fluid transfer connector” for establishing fluid communication between a fluid transfer unit and a container from which / into which fluid is to be transferred. The fluid transfer connector is optionally associated the fluid transfer unit itself. Optionally it is associated with another element to which a connection is made, e.g., connected to a container (in which case it may be more particularly referred to, e.g., as a “container connector”), and / or introduced into a process of fluid transfer by another part of the robotic system such as one of its manipulators. Connectors of various types are equivalently referred to as “adaptors”.

[0124] Fluid transfer conduit: In some examples, fluid transfer is described as being performed using a “fluid transfer conduit” penetrating the septum of a container to reach into container. A fluid transfer conduit may comprise a cannula or any other device configured for penetrating a container and transferring fluid therethrough. The fluid transfer conduit may include a bevel (e.g., it may be sharpened to form a needle) at a distal tip thereof or an opening at a side surface or any other configuration. It is to be understood herein that in some examples the transfer of fluid can be performed without the fluid transfer conduit penetrating through the container septum, or optionally not penetrating even though a septum of a fluid transfer connector (e.g., if one is associated with the fluid transfer assembly). In some examples, the fluid transfer is performed via a fluid transfer conduit by controlled pressure of the fluid. If the fluid transfer conduit comprises a needle or needle-like (sharpened) tip, the needle may penetrate any number of septa present. A fluid transfer conduit may penetrate all septa separating interiors of a container and a fluid transfer unit, one septum fully and another partially, one septum partially and another not at all, or no septum at all.

[0125] Fluid transfer assembly: “Fluid transfer assemblies” are described herein, e.g., with reference to assemblies including a syringe (as a fluid transfer unit) and optionally a syringe connector (as a fluid transfer connector). It is to be understood that that the fluid transfer assembly can include components for transfer of pharmaceuticals with function analogous to that of a syringe. For example, the fluid transfer assembly can include a pumping mechanism and a fluid transfer pipe configured to be connected to the container for the transfer of pharmaceuticals. Optionally, the fluid transfer assembly does not include the fluid transfer connector. For example, the fluid transfer connector can constitute a part of the robotic system operating the fluid transfer assembly. In some examples, the fluid transfer assembly can include a vial or an intravenous bag for exchange of fluid with other containers.

[0126] Septum: Herein, a “septum” generally refers to a membrane configured to close access to a part of a device to which it belongs. A septum on a container or container connector (also referred to as container-septum) may seal the container. A septum on a fluid transfer assembly (also referred to as fluid transfer connector septum) may prevent or resist access to and / or by a fluid transfer conduit. Typically, a septum is made of a resilient pierceable material. Such material may be a polymer with elastic properties like rubber. Container: In performing fluid transfers, robotic systems operating in accordance with the present disclosure optionally manipulate, and / or inspect variously embodied containers. A “container” as described herein optionally refers to any one or more of syringes, IV bags, elastomeric pumps, vials, bottles, ampules, syringes, conduits, pipes, or generally any vessel or receptacle suitable for holding fluids or liquids. It is further to be understood that the container can be any other element functioning as a component of a fluid transfer apparatus, with or without a connector (or “adaptor”) for establishing fluid communication of the container with other fluid transfer components. For example, the container can be a vial along with a vial adaptor, or an intravenous bag along with a spike adaptor. The container can be accessible via a container septum which can be a septum of the container lid or can be a part of the connector. In a process of fluid transfer performed using fluid pressure changes and / or differentials, a container characteristically experiences transfer of fluid due to a pressure change generated in and / or via a fluid transfer assembly with which it is connected.

[0127] Vial: As referred to herein, a “vial” (e.g., referring to a certain container) may include a closable vessel, formed for example of glass or plastic, such as an ampule or bottle, and containing a pharmaceutical in liquid or powder form. The vial can be a single or multiple use vial. The vial can be tubular or bottle shaped, having a neck portion in proximity to the vial opening. The vial can be topped with a cap.

[0128] Container assembly: As referred to herein, a “container assembly” may include: a container alone, or a container onto which a container connector is mounted. The term “vial assembly” is used equivalently, although examples embodying aspects of the present disclosure do not necessarily include a vial in a strict sense (e.g., an ampule may be present instead). A septum for at least partially sealing access to the vial can be located as part of the vial itself and / or as part of a container connector (equivalently referred to as a “vial adaptor” or “container adaptor”). The container connector may include a device mountable onto a vial, for facilitating transfer of the vial itself (by grasping onto the adaptor instead of grasping the vial) and / or for facilitating fluid transfer into or from the vial. The container connector may provide protected (e.g., “closed” and / or maintaining sterility) access to the contents of the vial. The container connector may be a single use or multiple use, sterilized device.

[0129] Manipulator: As referred to herein, a “manipulator” may include a structure and / or a mechanism configured to controllably interact with at least one container (c.g, a container loaded onto the system) and / or with other components or structures of the pharmaceutical preparation system. The manipulator can be configured to move the at least one container. The manipulator can be configured to cause or urge fluid transfer processes; for example, transfer fluid from one container to another, involving for example withdrawal of fluid and / or insertion (e.g., injection) of fluid. The manipulator may comprise a robotic arm, a platform, a robotic station, or a combination thereof configured for manipulating the container and / or the fluid transfer assembly. The manipulator can include an actuator, e.g., a motor for facilitating its operation.

[0130] Manipulators are not necessarily implemented as “arms” as such, even when described in relation to such terminology. For example, several examples herein are described in relation to a syringe equipped with a plunger, with the plunger and its piston being manipulated by a plunger arm. It should be understood that the plunger and piston are a non-limiting example of a mechanism which induces fluid pressure changes when appropriately manipulated by any suitable device; e.g., a screw, weight, spring, wedge, lever, or another pressure generating and / or transmitting device.

[0131] It should also be understood that pressure changes may be induced in the fluid contents of a fluid transfer unit to urge them out of the fluid transfer unit or into it using an arrangement that omits and / or does not make use of an element (e.g., a plunger shaft) which protrudes from a piston to allow its manipulation. It should be understood that, in some examples, an arrangement is optionally provided which omits and / or augments a piston while providing another pressure-transmitting arrangement of elements; for example, rollers operating on tubing as in a peristaltic pump, hydrostatic pressure, and / or another method operable to alternately shrink or expand a fluid-containing reservoir of the fluid transfer unit, and / or simply exert a pressure on fluid contents of the fluid transfer unit which results in the transfer of fluid. The class of such devices overall is also referred to herein as “fluid pump” devices, which operate to urge transfer of fluid into or out of the fluid transfer unit (and / or a fluid transfer assembly of which it is a part) according to a pressure exerted by the pump. In particular, a syringe engaged by its plunger with a plunger arm of a pump that moves the plunger provides elements which are used by a fluid pump in some examples.

[0132] The fluid transfer may occur while the fluid transfer assembly is engaged (e.g., gripped) by a manipulator. Engagement (e.g., by a gripper) optionally serves to stabilize the fluid transfer assembly while a pump of whatever sort operates to change pressure on its fluid contents such that they are transferred to another container. In some examples, a first manipulator engages the fluid transfer assembly (e.g. , a fluid transfer unit and / or a fluid transfer connector), assisting in stabilizing a portion of the fluid transfer assembly, while a second manipulator operates to exert pressure changes upon fluid contents of the fluid transfer unit. In an example, a manipulator (e.g., a “gripper” or “plunger arm”) can include one or more actuators used in engaging a syringe, and / or pulling or pushing a plunger of a syringe. Manipulators are optionally configured to manipulate other types of fluid containers such as vials, IV bags, tubing and / or another suitable container.

[0133] Controller: Herein, the equivalent terms “controller” and “controller unit” generally refer to circuitry configured to command some aspect of the behavior of a controlled element, e.g., operation of an actuator (which in turn may be an actuator of a maniuplator), operation of a sensor, and / or operation of an imager. The controller, in some examples, comprises computerized circuitry configured to perform operations in accordance with a set of instructions stored on a memory readable by the controller, which may be executed, e.g., by a central processing unit (CPU), one or more processors, processor units, and / or microprocessors. Additionally or alternatively, in some examples, the controller uses a digital signal processor (DSP), field-programmable gate array (FPGA), specialized application specific integrated circuit (ASIC), or another device. Additionally or alternatively, in some examples, a controller or controller unit includes one or more analog (e.g., amplifier feedbackbased) and / or low-level logic gate-based control circuits. In some examples, the control unit can include one or more mechanism controllers. The controller unit may comprise any means to control elements in the robotic pharmaceutical preparation system and may comprise at least one of analog control circuitry, a synchronizing unit, and a processor.

[0134] Imager: Herein, the term “imager” refers to any device which operates to produce an image of some target. An example of an imager is an optical camera; e.g., a camera equipped with one or more transparent lenses and a light sensor which can be read out to produce a digital image. Optionally, a scanning imaging method is used, e.g., imaging of reflectance returned to a sensor from a laser illumination scanned over the target. Optionally, interferometric imaging is used, e.g., to track small deformations and / or movements. Imaging using radiant energy other than visible light is not excluded; e.g., acoustic energy, electromagnetic wavelengths outside of the visible spectrum, and / or particle (with mass) radiation imaging. Optionally, contact imaging is performed, e.g., a contact probe is moved along an imaged target to confirm accuracy of its positioning and or measure one or more contours of its shape.

[0135] Before explaining at least one embodiment of the present disclosure in detail, it is to be understood that the present disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or given in the Examples. drawings. Features described in the current disclosure, including features of the invention, are capable of other embodiments or of being practiced or carried out in various ways.

[0136] Block Diagram of Components Supporting Image-Guided Fluid Transfer Unit Transport

[0137] Reference is now made to Fig. 1A, which illustrates elements of an example pharmaceutical preparation system (PPS) 99 with image-guided fluid transfer assembly type- and / or geometry-based process control, according to some examples of the present disclosure.

[0138] Fluid transfer assembly-manipulation subsystem 220, in some examples, manipulates a fluid transfer assembly 119 as part of one or more operations of PPS 99. Supported operations include, for example: gripping / releasing a fluid transfer unit 120 (e.g., at its body 121 and or connecting end 122) and / or fluid transfer connector 126 using a gripper 130; engaging with a plunger 137 of the fluid transfer unit 120 using plunger arm 125; drawing a fluid from a fluid container 275 (e.g., a vial 115) into fluid transfer unit 120; and / or injecting a fluid from fluid transfer unit body 121 into a fluid container 275 (e.g., an IV bag 116 or other container). It should be understood that injecting fluid into a vial 115 and withdrawing fluid from a bag 116 are not excluded.

[0139] In some examples, gripper 130 and plunger arm 125 are components of a fluid transfer assembly transporter 105 (e.g., as described in relation to Figs. 2 A- -2C and / or Figs. 2E-2J). Optionally, gripper controller 260 and / or plunger arm controller 270 are also part of fluid transfer assembly transporter 105; or they may be in communication with fluid transfer assembly transporter 105, e.g., via cabling, wireless communication, and / or another interconnection.

[0140] Fluid transfer unit connecting end 122 can be mated with fluid transfer connector 126 to form a fluid transfer assembly 119, which in turn is attachable to fluid container 275. Fluid transfer unit 120 comprises fluid transfer unit plunger 137, inserted into fluid transfer unit body 121

[0141] Fluid transfer unit-manipulation subsystem 220, in some examples, includes plunger arm controller 270; operable to control movements of a mechanical plunger arm 125 (described, e.g., in relation to Figs. 2A-2C and Figs. 2E-2F). While plunger arm 125 is engaged with fluid transfer unit plunger 137 (e.g., via fluid transfer unit body flange 135), controlled movements to withdraw fluid transfer unit plunger 137 from fluid transfer unit body 121 draw fluid from fluid container 275 into fluid transfer unit body 121. Conversely, controlled movements to push fluid transfer unit plunger 137 into fluid transfer unit body 121 inject fluid from fluid transfer unit body 121 into fluid container 275. According to the construction of fluid transfer unit 120, there is an available range of motion of plunger 137 relative to fluid transfer unit body 121; z.e., a range limited by a position with piston 123 of plunger 137 at the limits of its movement near the connecting end of fluid transfer unit body 121, and position with piston 123 of plunger 137 withdrawn from fluid transfer unit connecting end 122 to its maximum extent.

[0142] Fluid transfer unit-manipulation subsystem 220, in some examples, includes gripper controller 260; operable to control movements of gripper 130 to grip or release fluid transfer assembly 119, e.g. , at fluid transfer unit connecting end 122, fluid transfer unit body 121, and / or fluid transfer connector 126. Optionally, gripper controller 260 is operable to place gripping elements of gripper 130 (e.g., jaws 130A, 130B) in an appropriate gripping position relative to a gripped location along fluid transfer assembly 119. Fluid transfer unit-manipulation subsystem 220 is also described in relation to Fig. 3A, herein.

[0143] System controller 210 includes processing circuitry 217 comprising processor 215 and memory 225. Memory 225 stores instructions for processor 215, as well as data generated as processor 215 carries out the instructions. Memory 225 optionally stores image and / or measurement data produced by PPS 99 and / or accessed by processor 215 while carrying out the instructions; e.g, images obtained from imager controller 230 and one or more imagers 240 of imager subsystem 350.

[0144] Operable connection of system controller 210 to fluid transfer unit-manipulation subsystem 220 can be, for example, via a bus or network connection. Optionally, gripper controller 260 and / or plunger arm controller 270 are implemented using (at least in part) circuitry of system controller 210. Optionally, gripper controller 260 and / or plunger arm controller 270 are implemented as separate components.

[0145] System controller 210 preferably operates at a level at least partially abstracted from hardware manipulation details handled by gripper controller 260 and / or plunger arm controller 270. System controller 210 is operable, for example, to command fluid transfer unitmanipulation subsystem 220 to move fluid transfer unit plunger 137 by a certain distance to draw a targeted quantity (e.g., volume) of a fluid (such as a component of a pharmaceutical to be injected into a patient) into fluid transfer unit body 121. In response, plunger arm controller 270 handles conversion of the requested distance into signals appropriate to move plunger arm 125 accordingly. Optionally, plunger arm 125 is responsible for detection and reporting of exception conditions such as reaching limits of motion, and / or inconsistency between command movements and movements actually resulting. Upon receiving such a report, system controller 210 handles effects on overall device operation.

[0146] Additionally or alternatively, system controller 210 may receive exception reports and / or indications of exception conditions from other sources (e.g., images obtained by imager controller 230, described next). Accordingly, system controller 210 may convert these exception conditions and / or indications into appropriate additional commands provided to command fluid transfer unit-manipulation subsystem 220.

[0147] Imager 240, in some examples, comprises one or more digital imagers configured to image components of the PPS 99 and / or operations conducted by fluid transfer unitmanipulation system 220. In some examples, imager 240 is located in a fixed position relative to fluid transfer assembly 119, e.g., mounted on and moving along with fluid transfer assembly transporter 105.

[0148] In some examples, imager 240 can be positioned so that it captures a digital image of fluid transfer assembly 119 from a particular (e.g., selected) imager distance 295. Movements of imager 240 are optionally performed manually and / or automatically.

[0149] Additionally or alternatively, imager distance 295 is selected by movement of fluid transfer assembly 119 while attached to fluid transfer assembly transporter 105. Additionally or alternatively, a field of view of imager 240 (e.g., corresponding to one of the fields of view 102A, 102B of Figures 2I-2J) is selected by operation of the optics of imager 240, and / or by selecting a particular imager 240 according to its available fixed and / or adjustable field of view characteristics.

[0150] Imager controller 230, operably connected to the at least one imager 240, implements imager control (e.g., in response to commands from system controller 210, with which it is also operably connected). Moreover, it provides digital image access to system controller 210, e.g., as described in relation to Fig. 3B.

[0151] Flow Diagram of Image-Guided Fluid Transfer Unit Transport

[0152] Reference is now made to Fig. IB, which is a schematic flow diagram of a method of image-guided control of a fluid transfer unit manipulation process, according to some examples of the present disclosure.

[0153] At block 50, in some examples, one or more images of the fluid transfer assembly 119 to be manipulated is accessed (e.g., by processing circuitry 217, e.g., processing circuitry of a system controller 210). In some examples, the one or more images are obtained (e.g, obtained under the control of system controller 210) using imaging subsystem 350, e.g., as described in relation to Fig. 3B.

[0154] The fluid transfer assembly 119 is optionally a fluid transfer assembly 119 in a fluid transfer assembly depot 100 (e.g., as described in relation to Figures 2 A -2C and / or Fig. 21) selected for engagement with fluid transfer assembly transporter 105. Alternatively, the image is of a fluid transfer assembly 119 already engaged with fluid transfer assembly transporter 105

[0155] At block 52, in some examples, the image accessed at block 50 is processed to determine one or more characteristics of the fluid transfer unit. Image processing is also discussed, for example, in relation to Fig. 3B.

[0156] In some examples, a characteristic of a fluid transfer assembly 119 is determined by a direct measurement of the characteristic itself, made using the image. For example, an image region corresponding to the fluid transfer assembly 119 is identified, and a diameter of a portion of the fluid transfer unit is determined according to a size of the fluid transfer unit as represented in the image. This may comprise determining a scaling of elements visible in the image, or the scaling may be treated as fixed, e.g., as always applying in a given set of circumstances.

[0157] In some examples, the characteristic of the fluid transfer unit is a static characteristic; e.g., a geometrical property such as a fluid transfer unit body diameter or length, a diameter of a connecting end locking region, a shape of a connecting end of the fluid transfer unit (e.g., an angle characterizing a substantially conical taper of the connecting end), or a shape of a fluid transfer unit piston. Such a characteristic may be typical of a fluid transfer unit type, and potentially useful for type identification, as described below.

[0158] Additionally or alternatively, the characteristic of the fluid transfer unit is dynamic or potentially dynamic. For example, the image may be used to determine deformation of the fluid transfer unit as it is operated — e.g., a bowing and / or twisting deformation of a shaft of a plunger, or a bulging deformation of a body of the fluid transfer unit. Such deformations may occur, for example, due to an unexpected blockage of fluid in response to manipulation. As another example, movement of the fluid transfer unit may be detected as the characteristic of the fluid transfer unit. Such movement may be indicative of incorrect clamping, and / or incorrect and / or disrupted attachment of a fluid transfer connector to the fluid transfer unit (e.g. , a fluid transfer connector used to adapt a fluid transfer unit to allow fluid communication with a container such as a vial and / or IV bag). In some examples, the movement is of an element other than the fluid transfer unit relative to the fluid transfer unit, e.g. , a translation or or rotation of the fluid transfer connector.

[0159] Additionally or alternatively, manipulation of the fluid transfer unit may be monitored using images. For example, imaged states of the fluid transfer unit as commands are executed to advance or withdraw its plunger may be compared to expected states. Mismatches may be indicative of a fault condition and / or indicative of a need to adjust and / or recalibrate manipulation commands. In some examples, contents of the fluid transfer unit are monitored by image, e.g., monitored to detect bubble generation (by ingress and / or changes in vapor pressure).

[0160] Additionally or alternatively to direct characteristic measurement: in some examples, a fluid transfer unit characteristic is determined by first identifying a type of the fluid transfer unit. The type identification is used to determine fluid transfer unit data appropriate to the type. For example, a data structure defining characteristics of the fluid transfer unit may be selected from among a plurality of available fluid transfer unit-characterizing data structures, according to the type identification. The type identification itself may be performed using any suitable aspect of fluid transfer unit appearance identifiable in the image. The aspect may comprise a digitally encoded value; for example, a value encoded in a bar code, QR code, or by another type of pattern marked on the fluid transfer unit. In some examples, the aspect comprises a marking provided for another purpose which is incidentally useful for fluid transfer unit type identification. Examples include: a logo (e.g., a manufacturer’s trademark), spacings of scale markings, and / or characteristic appearances and / or relative positions of glyphs used in scale labeling.

[0161] As noted above, in some examples, one or more directly measured characteristics of the fluid transfer assembly 119 (e.g., its diameter and / or length) are used as a type-identifying aspect of the fluid transfer unit.

[0162] In some examples, fluid transfer unit characteristic identification comprises joint use of data from a plurality of sensor modalities (e.g., including non-image sensing).

[0163] For example, in some examples, an RFID code read from an RFID device attached to a fluid transfer assembly 119 may be used to identify its type and / or its characteristics directly, in whole or in part. Fluid transfer unit characteristics may be derived (e.g., by selection of a data structure and / or by mapping a value directly to a characteristic) using the RFID code. Optionally, imaging is used to verify that the fluid transfer assembly 119 conforms to the type indication provided by the RFID tag, e.g., it verifies that the RFID tag’s information is consistent with the fluid transfer unit which is actually visually present. Imaging is optionally used thereafter to monitor manipulation of the fluid transfer unit, e.g., to verify performance as the fluid transfer assembly 119 is manipulated, according to its characteristics.

[0164] At block 54, in some examples, the fluid transfer unit is manipulated according to a value of an operating parameter which is determined in turn according to the one or more fluid transfer unit characteristics determined at block 52.

[0165] Examples of operating parameters include those which govern positioning of elements of a fluid transfer assembly transporter 105 which engage with the fluid transfer assembly 119; for example: an appropriate gripping diameter used with a gripper 130, an appropriate size of a plunger flange 136 to be engaged with by a plunger arm 125, and / or an appropriate positioning of any of gripper 130, plunger arm 125, and / or fluid transfer assembly transporter 105 overall so that fluid transfer assembly 119 is in the right relative position to be engaged with.

[0166] Apart from guiding engagement of fluid transfer assembly 119 with fluid transfer assembly transporter 105, values of operating parameters may be selected so that fluid transfer assembly 119 is appropriately manipulated. For example, there is a potential benefit to performing manipulations of fluid transfer assembly 119 as quickly as is practical, consistent with constraining factors. The constraining factors may include, for example: targeted and / or maximum internal fluid transfer unit pressure, fluid transfer unit and / or contents-appropriate safety margins, viscosity of contents, actuator capabilities, sensitivity of contents to rough handling, fluid transfer unit-associate flow resistance, and / or strength of a container into which and / or from which fluid is being transported.

[0167] In some examples, the one or more characteristics of the fluid transfer unit are available as indirect indications of manipulation parameter values, e.g., a targeted maximum pressure of the fluid transfer unit is provided as a characteristic, and the system controller 210 takes this into account, potentially along with other system, contents, and / or container characteristics, in order to select a value of a parameter such as speed of advance of a fluid transfer unit plunger 137 which is targeted by actuation of plunger arm 125. Additionally or alternatively, the one or more characteristics of the fluid transfer unit are specified as parameter values directly; e.g., specified as a maximum plunger velocity.

[0168] Furthermore, and however operating parameter values are first selected: in some examples, verification of the manipulation of fluid transfer assembly 119 is performed using images obtained during the process of fluid transfer unit manipulation. For example, images may be obtained which show that actual changes in the position of a fluid transfer unit plunger 137 are consistent with what was commanded; and / or consistent with monitoring measurements made using another sensor type, such as an actuator encoder, a pressure sensor, a limit sensor, or another sensor. In some examples, images and image processing are used to ensure that fluid transfer unit 120 and / or elements to which fluid transfer unit 120 is connected such as a fluid transfer connector 126 remain in a stable configuration as manipulation is applied to fluid transfer assembly 119. In some examples, images and image processing are used to verify that contents of the fluid transfer unit are contained as expected (e.g. , that there are no leaks characterized by dripping, spraying, and / or mismatching of expected positions with actual positions). Optionally, radiation imaging is used to verify that there are no radioactivity leaks. In some examples, images and image processing are used to verify that contents of the fluid transfer unit are not subject to bubble formation, e.g., as a result of vaporization due to lowered pressures during withdrawal of fluid transfer unit plunger 137.

[0169] Optionally, when verification results indicate an exception from what is expected, operations of PPS 99 are paused, and / or an alert is generated. Optionally, e.g., when expected performance is subject to normal variation and / or undetermined in advance, verification results are used to adjust values of operating parameters to bring actual operation into conformity with target metrics such as speed of pharmaceutical preparation.

[0170] Pharmaceutical Preparation Systems

[0171] Reference is now made to Figs. 2A- -2C, which illustrate elements of an example pharmaceutical preparation system (PPS) 99, according to some examples of the present disclosure.

[0172] Figs. 2A and 2B show different examples of a PPS 99 in overview. Fig. 2C shows the example of Fig. 2B with some elements partially suppressed (dimmed) in order to emphasize elements of particular relevance to descriptions herein.

[0173] In some examples, PPS 99 includes vial holding unit 110, which holds fluid vial 115. Fluid vial 115 in turn contains fluid to be drawn into and / or received from a fluid transfer unit 120; during, for example, a process of robotic preparation of a pharmaceutical for injection and / or infusion.

[0174] The illustrated examples of PPS 99 include fluid transfer assembly depot 100 including fluid transfer units available for use by the PPS. In the example of Fig. 2A, fluid transfer assembly depot 100 is implemented as a linear queue of fluid transfer units. In the example of Figure 2B, fluid transfer assembly depot 100 is implemented as a fluid transfer assembly carousel. In some examples, imaging capability is provided using one or more digital imagers. In some examples (e.g., Fig. 2B).jimager tower 101 is positioned where one or more of its imagers can be used to observe fluid transfer assembly transporter 105 and / or fluid transfer units of fluid transfer assembly depot 100. Optionally, one or more imagers are placed in another location; for example, integrally with one or both of fluid transfer assembly transporter 105 and the elements of fluid transfer assembly depot 100 (e.g., within the housing of a fluid transfer assembly carousel). Optionally, an imager provided with another element of PPS 99 is used to observe at least some operations of fluid transfer assembly transporter 105; e.g., an imager placed on stand observation arm 102, an imager placed on vial observation unit 103, or an imager placed in another location. Optionally, images may be provided from one or more imager sources outside of PPS 99 itself; for example, a roving monitor device which can be manually or automatically controlled to obtain images from dynamically selected points of view, e.g., to supplement on-device imaging capabilities when image inputs are otherwise determined to be insufficient (e.g., ambiguous, and / or in need of more detailed diagnostic attention).

[0175] The illustrated examples of PPS 99 include fluid transfer assembly transporter 105 that transports fluid transfer units. In some examples, the fluid transfer assembly transporter 105 can move to remove a fluid transfer assembly 119 from fluid transfer assembly depot 100, and then move among different locations (e.g., along motion axis 105A, as illustrated in Fig. 2B to prepare an injection according to a particular preparation sequence. In some examples, there may be motion along another axis which brings transfer assembly transporter 105 into a proper alignment with transfer assembly depot 100, and / or into a proper alignment with a fluid container with which fluid transfer assembly 119 is to exchange fluid contents. Motions should be understood as relative motions; e.g., they optionally involve movement of transfer assembly transporter 105 itself, and / or movement of another component of PPS 99; for example, an elevating platform.

[0176] Moreover, operating in its capacity as a pump and / or operating portions thereof, fluid transfer assembly transporter 105 manipulates the fluid transfer assembly 119 which it carries to extract liquid into the fluid transfer unit 120 (e.g., from a vial 115), and / or to inject liquid from the fluid transfer unit 120, e.g., into a pharmaceutical receptacle such as bag 116 (e.g., an intravenous bag, also referred to herein as an IV bag) which has been positioned on a transfer stand 117 (Fig. 2B).

[0177] In some examples, fluid transfer assembly transporter 105 includes gripper 130, which engages with fluid transfer assembly 119 to hold it during a compounding process. More particularly, gripper 130 optionally engages with fluid transfer unit body 121, fluid transfer unit connecting end 122, and / or fluid transfer connector 126 of fluid transfer assembly 119. Furthermore, fluid transfer assembly transporter 105 includes plunger arm 125, operable to grasp a plunger 137 of fluid transfer unit 120; e.g., at plunger flange 136, and / or along a shaft of fluid transfer unit plunger 137.

[0178] During a compounding process: once plunger arm 125 engages fluid transfer unit plunger 137, and while body 121 of fluid transfer unit 120 is restrained (e.g., by gripper 130), movement of plunger arm 125 in the direction of fluid transfer unit connecting end 122 pushes piston 123 of fluid transfer unit plunger 137 further into fluid transfer unit body 121. Movement of plunger arm 125 in the opposite (proximal) direction pulls piston 123 of fluid transfer unit plunger 137 toward the base of the fluid transfer unit body 121, z.e., towards fluid transfer unit body flange 135.

[0179] Fluid Transfer Unit Assemblies and Fluid Transfer Unit Transporters

[0180] Reference is now made to Fig. 2D, which schematically illustrates a fluid transfer assembly 119, according to some examples of the present disclosure. Further reference is made to Figs. 2E- -2F, which schematically illustrate an example of a fluid transfer assembly transporter 105, according to some examples of the present disclosure.

[0181] More particularly, Fig. 2D illustrates features of a fluid transfer assembly 119, while Figs. 2E-2F show fluid transfer assembly 119 held by fluid transfer assembly transporter 105 in front view (Fig. 2E) and from an isometric perspective view (Fig. 2F). In the front view of Fig. 2E, piston 123 of fluid transfer unit plunger 137 is seen beyond a cutaway view 121A into body 121 (cutaway view 121A is for purposes of illustration only, and is not a structural element of body 121).

[0182] Fig 2D illustrates a fluid transfer assembly 119, including, in addition to fluid transfer unit 120, fluid transfer connector 126 (engaged distally with fluid transfer unit connecting end 122, e.g., via a Luer taper connector) and connector septum 131 (engaged distally with fluid transfer connector 126).

[0183] In some examples, fluid transfer connector 126 is a device which provides safe attachment of fluid transfer assembly 119 to e.g, a vial or intravenous (IV) bag. For example, it may include features which prevent and / or mitigate risks of accidental disconnection and / or partial connection, and / or features which prevent and / or help control pressure differentials generated due during fluid injection from and / or withdrawal into fluid transfer unit 120. In some examples, connector septum 131 comprises a surface which acts to maintain isolation from contamination, and which a cannula (e.g., a needle) pierces to allow drawing and / or injection of fluid.

[0184] Optionally (e.g., as shown in Figs. 2E-2F), plunger arm 125 comprises one or more recesses 125A, 125B which are differently sized to receive differently-sized portions of fluid transfer unit plunger 137 such as different sizes of plunger flange 136. During operations to engage with a fluid transfer assembly 119, the fluid transfer unit manipulation sub-system 220 optionally selects which of recesses 125A, 125B to engage according to a detected fluid transfer unit geometry and / or type, e.g., a fluid transfer unit geometry and / or type detected by digital image processing, for example as described herein. Selection may be performed by movement of plunger arm 125 to a suitable position along movement axis 125C (Fig. 2E).

[0185] Gripper Operation

[0186] Reference is now made to Figs. 2G- -2H, which illustrate (using top views) an example of a gripper 130, according to some examples of the present disclosure. In some examples, gripper 130 comprises two jaws 130A, 130B, which separate to create an entry way suitable in size to accept a range of diameters of fluid transfer unit body 121, fluid transfer unit connecting end 122, and / or fluid transfer connector 126. For example, an accepted range of diameters may comprise diameters of 5-10 mm, 6-8 mm, 5-25 mm, or another range. The range may include larger values (e.g., up to 20-30 mm) in particular for a gripper 130 which attaches along body 121. The range may be confined to relatively narrow diameters (e.g, diameters < 10 mm) for a gripper 130 which is designed to attach to a protruding cylindrical portion of fluid transfer unit connecting end 122, e.g, a portion which receives and locks on to fluid transfer connector 126, and / or fluid transfer connector 126 itself.

[0187] In some examples, jaws 130A, 130B are themselves configured to accommodate a range of diameters (that is, more than one diameter). For example, jaws 130A, 130B may comprise a flexible inner lining which adjusts (e.g., compresses) to conform to various diameters of the grasped fluid transfer unit portion. In some examples, each of jaws 130A, 130B comprises a plurality of elastically interconnected portions (e.g., spring-interconnected) which separate from each other to an extent appropriate to accommodate the grasped portion of a fluid transfer assembly 119.

[0188] Adjustments of gripper 130 to accommodate different diameters are optionally active and / or passive. In some examples, rather than ensuring that a fluid transfer unit is gripped with continuous contact all around its circumference, a gripper 130 is configured to ensure contact at at least 3 or more (at least sometimes discrete) locations distributed around the circumference. For example, gripper 130 may comprise at least three separate jaws. In some examples, jaws 130A, 130B can be extended from a housing 105B of fluid transfer assembly transporter 105 to a variable extent. They may use housing 105B itself and / or an extension from housing 105B as a “third jaw”, such that fluid transfer assembly 119 is clamped laterally between jaws 130A, 130B, and also between one or both of jaws 130A, 130B and housing 105B and / or the extension from housing 105B. The extension from housing 105B may itself be actively actuated, or it may be a static element against which jaws 130A, 130B compress fluid transfer assembly 119.

[0189] Positioning of jaws 130A, 130B relative to fluid transfer assembly 119 is optionally controllable by any one or more of: adjusting where jaws 130A, 130B are positioned along a distal / proximal axis of fluid transfer assembly 119; adjusting a depth of entry of fluid transfer assembly 119 to within a grasping region defined by gripper 130 (e.g., defined by jaws 130A, 130B); and / or adjusting lateral centering of fluid transfer assembly 119 within gripper 130 (e.g., within jaws 130A, 130B). Actuators which adjust positioning may act, for example: upon the fluid transfer assembly 119 (e.g., by advancing or otherwise moving fluid transfer assembly depot 100 itself); upon the jaws 130A, 130B (and / or another element of gripper 130 itself); and / or upon the fluid transfer assembly transporter 105 as a whole. Selection of target positioning is optionally based on positions known from actuator encoder measurements. In some examples, image processing (of images of the fluid transfer unit and / or fluid transfer assembly transporter 105) is used to confirm actuator encoder measurements, e.g., to ensure that a fluid transfer assembly 119 is properly seated in its holder so that the actuator encoder measurements can be relied on. Optionally, image processing is used as a primary source of input data which guides movement of components fluid transfer unit manipulation subsystem.

[0190] In some examples, more than one gripping device (e.g., more than one pair of jaws 130A, 130B) is provided for use by gripper 130, and the fluid transfer assembly transporter 105 is operated to select an appropriately sized gripping element, according to the type, geometry, and / or gripping location of fluid transfer assembly 119.

[0191] In some examples, one or more gripping devices of gripper 130 are implemented otherwise than as a pair of jaws. For example, gripper 130 may be implemented as a noose which is slipped over a distal or proximal end of fluid transfer assembly 119 (optionally a distal or proximal end of fluid transfer unit 120 as assembled with its fluid transfer connector 126). The noose may be tightened, once generally in position, to secure fluid transfer assembly 119 in place. In some examples, a gripping device of gripper 130 is implemented as a single “jaw” which moves from an acceptor position that allows entry of the fluid transfer unit to a gripping position that closes off the entry. For example, such a single jaw may extend from fluid transfer assembly transporter 105 along a first side of fluid transfer assembly 119, curve around fluid transfer assembly 119 (e.g., curve as it extends), then re-engage with fluid transfer assembly transporter 105 on a second side of the fluid transfer unit. At this stage, the gripping device may be locked into place (e.g., locked at the second side of the fluid transfer unit), and optionally tightened or otherwise adjusted to fit the diameter of the fluid transfer unit at the location of the fluid transfer unit which it engages.

[0192] Fluid Transfer Unit Transporter Imaging

[0193] Reference is now made to Figs. 21 2.J, which illustrate (in top views) imaging of fluid transfer assembly transporter 105, according to some examples of the present disclosure. For clarity of illustration, elements ofPPS 99 other than imager tower 101, carousel-implemented fluid transfer assembly depot 100, and fluid transfer assembly transporter 105 itself are suppressed in Figs. 21 2.J, but should be understood to be present as appropriate for various overall examples of a PPS 99.

[0194] As described, for example, in relation to Fig. 2B, imagers may be placed in any one or more of several locations to observe fluid transfer assembly transporter 105. In the example shown, imager tower 101 comprises one or more imagers 240, which are oriented and operable to allow imaging of fluid transfer assembly transporter 105 at any of its locations along axis 105A. Optionally, imager tower 101 is provided with a variable field of view; e.g., adjustable between a first field of view 102A (Fig. 21) appropriate to imaging fluid transfer assembly transporter 105 when it is engaged with fluid transfer assembly depot 100, and a second field of view 102B (Fig. 2 J) when it is at the opposite end of its available length of travel, e.g., engaged with vial holding unit 110. Field of view changing may be performed, e.g., by operating zoom optics, and / or by switching among a plurality of imagers. In some examples, a resolution of imager 240 is high enough that sufficiently imaging resolution is achieved at all available positions of fluid transfer assembly transporter 105, optionally without adjustment of field of view. Image processing is optionally limited to a region of imager images selected based on a known position of fluid transfer assembly transporter 105 relative to a suitably positioned imager 240; e.g., a relative position known based on actuator encoder measurements, and / or known based on a previous stage of imagine processing. In some examples, illumination is provided using an illuminator 106 positioned on fluid transfer assembly transporter 105 itself. Additionally or alternatively, illumination is provided from one or more illuminators positioned elsewhere upon PPS 99, and / or provided by illuminators with the operating environment of PPS 99.

[0195] Fluid Transfer Unit Manipulator Subsystem — Gripper Control

[0196] Reference is now made to Fig. 3A, which illustrates a detailed block diagram of an example fluid transfer unit manipulation subsystem 220, with example interfaces to a gripper 130 and to a plunger arm 125, according to some examples of the present disclosure.

[0197] Gripper 130 can be a physical device for gripping a portion of fluid transfer assembly 119 such as a fluid transfer unit body 121, fluid transfer unit connecting end 122, and / or fluid transfer connector 126; e.g., as described in relation to Figs. 2 A -2C and / or Figs. 2E- -2H. In some examples, constriction and release of gripper 130 is controlled via gripper controller 260, comprising both actuator and control functions in the example shown. Physical movements leading to motions of gripper 130 are implemented by gripper actuator 320. In an example of how a gripper actuator 320 may be implemented, gripper actuator 320 can include registers 320A, which in turn can provide a logical control interface to gripping control unit 335. Additionally or alternatively, gripping control unit 335 provides control signals directly to gripper actuator 320. Additionally or alternatively, processing circuitry 217 (e.g., processing circuitry 217 of system controller 210) commands gripper actuator 320 directly.

[0198] The following examples are described from the point of view of a register-based implementation approach. It should be understood that other implementation approaches are equivalently available to allow control of the functionalities mentioned, e.g., using analog control lines, signaling via a non-register protocol such as serial interface command protocol, or by another method.

[0199] In some examples, registers 320 A include a control register which, when written to by gripping control unit 335, cause gripper 130 to grip a suitably sized object located within the gripping proximity of gripper 130 (e.g., between its open jaws). In some examples, gripper controller 260 provides some other suitable mechanism to enable processing circuitry 217 and / or gripping control unit 335 to initiate gripping of an object.

[0200] In some examples, registers 320 A include a control register which, when written to by gripping control unit 335, cause gripper 130 to open ( / .< ., release any suitably sized object located within the gripping proximity of gripper 130). In some examples, gripper controller 260 provides some other suitable mechanism to enable processing circuitry 217 and / or gripping control unit 335 to initiate releasing of a gripped object.

[0201] In some examples, registers 320A include a control register which receives data indicative of a targeted gripping force (e.g., in units convertible to Newtons) to be utilized by gripper 130 when gripping. Processing circuitry 217 and / or gripping control unit 335 can then write the data indicative of the gripping force to be utilized when gripping. It should be understood that gripping force can be otherwise indicated; e.g., using a voltage which is treated as an analog indication proportional to targeted gripping strength, and / or which is itself used to drive gripper 130.

[0202] In some examples, registers 320A include a control register which receives data indicative of a distance (e.g., a diameter) between gripping jaws of gripper 130 (e.g., in millimeters) to be targeted by gripper 130 when gripping. Processing circuitry 217 and / or gripping control unit 335 can then write the data indicative of the gripping diameter to be utilized when gripping. It should be understood that gripping force can be otherwise indicated; e.g., using a voltage which is treated as an analog indication proportional to targeted size of a gripped object.

[0203] Additionally or alternatively, gripper controller 260 provides another suitable mechanism to enable processing circuitry 217 and / or gripping control unit 335 to specify gripping force and / or targeted jaw distance during gripping.

[0204] In some examples, registers 320 A include a control register which, when written to by processing circuitry 217 and / or gripping control unit 335, cause gripper 130 to move a specified distance in a specified direction along fluid transfer assembly 119 (e.g., to move upwards by 5 millimeters). In this manner, processing circuitry 217 and / or gripping control unit 335 can control the position along fluid transfer assembly 119 where gripper 130 will grip. Additionally or alternatively, registers 320A provide a control register which, when written to by processing circuitry 217 and / or gripping control unit 335, cause gripper 130 to move in a specified direction until halted; e.g., by a subsequent write to a different control register.

[0205] Additionally or alternatively, gripper controller 260 provides some other mechanism to enable processing circuitry 217 and / or gripping control unit 335, to control position of gripper 130 along fluid transfer assembly 119.

[0206] In some examples, registers 320A include a read register which provides data indicative of a measure of friction between gripper 130 and a gripped object. Processing circuitry 217 and / or gripping control unit 335, can then read from this register to determine the current measure of friction (for example: in units convertible to a friction coefficient). Additionally or alternatively, gripper controller 260 optionally provides some other suitable mechanism to enable processing circuitry 217 (e.g. gripping control unit 335) to access the measure of friction between gripper 130 and the gripped object.

[0207] In some embodiments, elements of PPS 99 itself are used to measure the measure of friction. For example, the grip of gripper 130 is gradually loosened until a known force (e.g., a force exerted upon body 121 or another portion of gripped fluid transfer assembly 119) is sufficient to slide fluid transfer assembly 119 a detectable amount. One or more images of fluid transfer assembly 119 may be obtained in order to determine whether or not slippage has yet taken place. Knowing the restraining force of gripper 130 and the exerted force at the moment of slippage allows calculation of a coefficient which is and / or is indicative of the measure of friction.

[0208] Fluid Transfer Unit Manipulator Subsystem — Plunger Arm Control

[0209] Plunger arm 125 can be a physical device for moving a plunger 137 into and / or out of a fluid transfer unit body; for example, as described in relation to Figs. 2A- -2C and / or Figs. 2E- 2G. Motion of plunger arm 125 can be controlled by plunger arm controller 270, e.g., as outlined in relation to Figure 1A. Optionally, plunger arm controller 270 includes registers 320B, which in turn can provide a logical interface to plunger arm actuator 321 from plunger arm control unit 345, and / or from processing circuitry 217 directly.

[0210] The following examples are described from the point of view of a register-based implementation approach. It should be understood that other implementation approaches are equivalently available to allow control of the functionalities mentioned, e.g., using analog control lines, signaling via a non-register protocol such as serial interface command protocol, or by another method.

[0211] In some examples, registers 320B provide one or more control registers which, when written to by processing circuitry 217 and / or plunger arm control unit 345, cause plunger arm 125 to move fluid transfer unit plunger 137 a particular distance in a particular direction, at a particular target velocity. In some examples, registers 320B include registers containing data indicative of distance, direction, and target velocity for movement of fluid transfer unit plunger 137. Processing circuitry 217 and / or plunger arm control unit 345 write to these registers to specify distance, direction, and target velocity for movement of fluid transfer unit plunger 137. In some examples, plunger arm controller 270 provides a different (e.g., non-register based) mechanism to enable plunger arm control unit 345 to control motion of fluid transfer unit plunger 137. Optionally, registers 320B include a read register which provides data indicative of an actual average velocity of a completed fluid transfer unit movement. For example, a register can contain an actual velocity of the most recent fluid transfer unit movement, or an actual movement time of the most recent fluid transfer unit movement (which, in conjunction with the movement distance, indicates the average movement velocity). In some examples, plunger arm controller 270 provides some other (e.g., non-register-based) suitable mechanism to enable plunger arm control unit 345 to monitor motion of fluid transfer unit plunger 137 and / or determine actual average velocity of a completed fluid transfer unit movement. Optionally, actual velocity readout is verified by or provided instead by image-based processing, for example as described in relation to Fig. 4B.

[0212] In some examples, portions of fluid transfer unit-manipulation subsystem 220 are implemented by processing circuitry 217, which in turn can include processor 215 and memory 225.

[0213] Processor 215 can include any suitable hardware-based electronic device with data processing capabilities, such as, for example, a general-purpose processor, digital signal processor (DSP), field-programmable gate array (FPGA), specialized Application Specific Integrated Circuit (ASIC), one or more cores in a multicore processor, or another device. Processor 215 optionally includes any suitable number of processors, ASICs, virtual processors, FPGAs, and combinations thereof.

[0214] Memory 225 comprises, for example, any suitable type of volatile and / or non-volatile storage. It can include one or more physical memory components. Memory 225 can be configured to, for example, store instructions for computation, as well as data used in and / or generated during computation.

[0215] Processing circuitry 217 can be configured for execution of any suitable number of functional modules in accordance with computer-readable instructions implemented on a non- transitory computer-readable storage medium. Such functional modules should be understood as being comprised in the processing circuitry 217. The functional modules can include, for example, gripping control unit 335, plunger arm control unit 345, and other units as appropriate for purposes of generating movement, as well as functional modules provided for other purposes, e.g., as described in relation to any of the figures herein.

[0216] In some examples, gripping control unit 335 implements logic to control gripper 130 to grip and release fluid transfer assembly 119, e.g. , by gripping fluid transfer unit body 121, fluid transfer unit connecting end 122, and / or fluid transfer connector 126 during pharmaceutical compounding operations. Gripping control unit 335 can induce gripper actuator 320 to perform the gripping / releasing, for example, in response to commands from system controller 210, of which processing circuitry 217 may be a part. In some examples, gripping control unit 335 performs gripping / releasing by writing to registers 320A. Again, the register-based control regime should be understood as an optional and non-limiting example; other optional control methods include, for example, serial communication, and / or analog signaling.

[0217] In some examples, gripping control unit 335 performs gripping of gripper 130 in accordance with identification information identifying fluid transfer assembly 119 by type, e.g. , as determined from images obtained by imager controller 230 and accessed and processed by system controller 210. Additionally or alternatively, relevant characteristics of fluid transfer assembly 119 are identified by measurement of fluid transfer assembly 119 geometry; e.g., measurements of fluid transfer unit size based on image processing.

[0218] By way of non-limiting example: optionally, gripping control unit 335 can, during a gripping procedure, control gripper 130 so as to constrict the gripping jaws to a particular diameter appropriate to the diameter of the particular fluid transfer assembly 119 at some location along its axial length (e.g., along the fluid transfer unit body 121, at fluid transfer unit connecting end 122, and or upon fluid transfer connector 126). In some examples, gripping control unit 335 determines an appropriate gripping diameter using a table of data that associates fluid transfer unit types and / or fluid transfer unit geometries with appropriate values of gripping diameter. Additionally or alternatively, the gripping control unit 335 selects an appropriate gripping diameter via another mechanism; for example, machine learning classification of fluid transfer unit type which may not explicitly rely on a specific aspect of how fluid transfer assembly 119 appears in images. In some examples, for example, image examples depicting a plurality of fluid transfer unit types are presented during a learning phase of production of a machine learning classifier, with each fluid transfer unit type itself being depicted under a variety of suitable conditions; e.g., at different scales and / or orientations, in different image contexts (backgrounds), and / or with different image qualities (e.g., quality of illumination, image resolution, depth of field, and / or quality of image focus). Using machine learning training techniques, e.g., for reinforcement of correct classifications by nodeassociation weight modification, arrival of a classifier to a capability for distinguishing fluid transfer units by type may not necessarily rely on a single clearly identified visual characteristic of the fluid transfer unit.

[0219] By way of further non-limiting example: if gripper 130 grips fluid transfer assembly 119 at a point that is relatively closer to a fluid transfer unit connecting end, the lever moment at the plunger 137 will be correspondingly relatively greater, so it may be comparatively easier to twist fluid transfer assembly 119 out of position in the case of non-aligned forces being applied; e.g., in case of buckling of a plunger 137.

[0220] In some examples, gripping control unit 335 utilizes a gripping location on fluid transfer unit body 121 that is suitable to e.g., the width, wall thickness, and / or manufacturer of the particular fluid transfer unit currently being utilized. For example, it may be preferable to grip a fluid transfer assembly 119 having a relatively more fragile plunger 137 at a location relatively closer to the proximal (basal) flange 135 of fluid transfer unit 120, to reduce risk of a loss of well-aligned engagement of fluid transfer assembly transporter 105 and fluid transfer assembly 119. In some examples, gripping control unit 335 determines the gripping height from a table that associates fluid transfer unit types with appropriate gripping height values. Additionally or alternatively, the gripping control unit 335 determines the gripping height via another mechanism (such as machine learning classification).

[0221] Plunger arm control unit 345 can control plunger arm 125 to insert or withdraw plunger 137 from fluid transfer unit body 121 (thereby either injecting fluid from fluid transfer unit body 121 into fluid container 175, or drawing fluid from fluid container 175 into fluid transfer unit body 121) during pharmaceutical compounding operations. Plunger arm control unit 345 can perform the insertion or withdrawal; operating, for example, in response to commands from system controller 210. In some examples, plunger arm control unit 345 controls insertion / withdrawal by writing to registers 320B.

[0222] In some examples, plunger arm control unit 345 controls plunger arm 125 for insertion / withdrawal using a movement distance / direction and / or target velocity that is in accordance with determined fluid transfer unit characteristics, e.g. , as may be determined using images obtained by imager controller 230 and accessed by system controller 210. In some examples, plunger arm control unit 345 controls plunger arm 125 for insertion / withdrawal at a target velocity that is selected in accordance with one or more determined characteristics of the fluid transfer assembly 119 (e.g., its resistance to flow), together with an accessed value for a viscosity of the fluid being drawn or injected. The fluid viscosity value may be expressed, for example, in units of centipoise, and may be used by system controller 210 to calculate a target velocity, and / or provided to control plunger arm control unit 345. In some examples, a value of a relevant parameter indicative of the viscosity of a fluid is determined empirically by the PPS 99; e.g., by a series of operations which withdraw / expel fluid into / from a fluid transfer unit 120, while measuring forces generated and / or velocities of movement generated during the operations. By way of non-limiting example: if target velocity utilized in movement is too low, the injection or withdrawal will take longer than necessary, thereby reducing throughput of the PPS 99. Conversely, if target velocity utilized in movement is too high, fluid insertion or withdrawal could fail, leakage could occur, bubbles could be generated due to excessively low vapor pressures created, and / or fluid transfer unit components could be damaged. Accordingly, in some examples, plunger arm control unit 345 sets a parameter of target velocity of plunger 137 to a value (for example: in units of mm / s) that is suitable to the particular fluid transfer assembly 119 being used. For example: suitable according to fluid transfer unit 120 width (diameter), fluid transfer unit 120 length, plunger 137 construction, fluid transfer unit body 121 wall thickness, fluid transfer unit 120 manufacturer, fluid transfer unit 120 rated peak operating pressure value, or another characteristic. In some examples, plunger arm control unit 345 sets the target velocity to a value (for example: in units or mm / s) that is suitable to fluid transfer unit contents; e.g., the viscosity of the fluid. Optionally, velocity values lower than a maximum otherwise permissible may be used, e.g., in cases where pharmaceutical preparation time is limited by a factor other than fluid transfer velocity, and / or waiting demand for use of PPS 99 is sufficiently low.

[0223] In some examples, plunger arm control unit 345 determines the target velocity from a table associating fluid transfer unit characteristics with appropriate values of target velocity. Optionally, this includes characteristics of a filled fluid transfer unit affected by its contents; for example, affected according to contents viscosity. Additionally or alternatively, plunger arm control unit 345 determines the target velocity via another mechanism such as machine learning classification, and / or empirical testing.

[0224] In some such examples, plunger arm control unit 345 makes dynamic adjustments to targeted plunger movements which reduce or increase a target velocity. This adjustment is performed, in some examples, using information indicative of the actual plunger movement average velocity as read from measurements made by using actuator sensors and / or registers (e.g., registers 320B), and / or as determined by image processing of images obtained via imager controller 230 and accessed by system controller 210. In some examples, image processingbased determinations of actual velocity are used to verify velocity measurements made using other sensors, e.g., to ensure that movements are not associated with performance problems such as leakage, damage, and / or loss of proper fluid transfer unit engagement. Imager Subsystem

[0225] Reference is now made to Fig. 3B, which schematically illustrates imaging and image processing elements of a PPS 99, according to some examples of the present disclosure.

[0226] In some examples, imager subsystem 350 comprises imager(s) 240 and imager controller 230. Functions of imager controller 230 comprise interfacing with imager(s) 240 to control image acquisition in accordance with high-level instructions from processing circuitry 217, and receiving captured images from imager(s) 240 to be accessed by processing circuitry 217.

[0227] Other functions related to image processing are optionally performed in whole or in part by imager controller 230; e.g., features such as those of fluid transfer unit identification unit 365 and / or fluid transfer unit geometry measurement unit 375 next described in relation to processing circuitry 217. However, for the sake of description, processing circuitry 217 and imager controller 230 are described as functionally distinct units.

[0228] In some examples, imager controller 230 is in functional communication with processing circuitry 217. Implementations of processor 215 of processing circuitry 217 optionally include any suitable hardware-based electronic device with data processing capabilities; for example, a general -purpose processor, digital signal processor (DSP), a field- programmable gate array (FPGA), a specialized Application Specific Integrated Circuit (ASIC), one or more cores in a multicore processor, etc. Processor 215B can also comprise, for example, a plurality of general -purpose processors, ASICs, virtual processors, and / or combinations thereof.

[0229] In some examples, memory 225 comprises, for example, a suitable kind of volatile and / or non-volatile storage; for example, one or more physical memory components. Memory 225 stores instructions for processor 215, as well as data generated as processor 215 carries out the instructions.

[0230] Processing circuitry 217 is configured to execute one or more functional modules related to image access and / or processing in accordance with computer-readable instructions implemented on a non-transitory computer-readable storage medium, e.g., stored by memory 225. Such functional modules are referred to hereinafter as being implemented by processing circuitry 217 (which may itself be part of system controller 210, and / or separately provided). Examples of these functional modules include imager interface unit 355, fluid transfer unit identification unit 365, and fluid transfer unit geometry measurement unit 375. Imager interface unit 355 communicates with imager controller 230 to control imager(s) 240; in particular as to acquire digital images including components of PPS 99 and / or fluid transfer assembly 119; e.g., fluid transfer connector 126, fluid transfer unit plunger 137, fluid transfer unit body 121, fluid transfer unit piston 123, fluid transfer unit connecting end 122, gripper 130, and / or plunger arm 125. Operations of interface unit 355 may in turn be subject to control, e.g., via commands from other functional units of system controller 210.

[0231] In some examples, fluid transfer unit identification unit 365 determines fluid transfer unit characteristics according to a fluid transfer unit type identified by image processing of a digital image provided by imager subsystem 350. Examples of fluid transfer unit characteristics include, for example, fluid transfer unit height, width, manufacturer, capacity, and / or model name. Fluid transfer unit characteristics optionally include whether and / or to what extent a fluid transfer unit plunger is partially withdrawn from the fluid transfer unit body.

[0232] Optionally, fluid transfer unit identification unit 365 determines fluid transfer unit characteristics according to identifying information visible in an image of a particular fluid transfer assembly 119. For example, the identifying information (suitably extracted by image processing) identifies the fluid transfer assembly 119 by type, and' the type is used to select fluid transfer unit type data which provides the associated fluid transfer unit characteristics. Image processing techniques used to extract the identifying information include, for example, line detection, thresholding, convolution and / or FFT based spatial frequency filtering, pattern matching, and / or image metrology. Optionally, illumination is controlled to selectively highlight fluid transfer assembly 119 and / or components thereof, e.g., backlighting, front lighting and / or patterned lighting may be used. Additionally or alternatively, fluid transfer unit identification unit fluid transfer unit identification unit 365 determines fluid transfer unit type via methods such as machine learning classification (e.g., using a library such as YOLO5). In some examples, fluid transfer unit identification unit 365 makes use of capabilities for fluid transfer unit geometry measurement provided by fluid transfer unit geometry measurement unit 375, and or implements such capabilities itself.

[0233] Fluid transfer unit geometry measurement unit 375, in some examples, implements one or both of (1) capabilities for measuring parameters of the gross (e.g., “normal”) geometry of a fluid transfer assembly 119, and / or (2) detecting changes and / or abnormalities in the geometry of fluid transfer assembly 119. Fluid transfer unit geometry measurement may be used to directly determine characteristics of a fluid transfer assembly 119, and / or used to assist in identifying a fluid transfer assembly 119; the identification being itself used, e.g., as described in relation to fluid transfer unit identification unit 365. Examples of gross geometry parameters include fluid transfer unit diameter (e.g., of fluid transfer unit body 121 and / or any suitable portion of fluid transfer unit connecting end 122 and / or fluid transfer connector 126), fluid transfer unit length (e.g., of fluid transfer unit body 121), shapes of fluid transfer unit components (e.g., shapes such as conic surface angles of piston 123 and / or fluid transfer unit connecting end 122, and shapes such as a wall thickness of fluid transfer unit body 121), and / or relative position of plunger 137 and fluid transfer unit body 121. Finding the relative position of plunger 137 and fluid transfer unit body 121 may alternatively be understood, e.g., as characterizing (as a part of measuring) a volume of the contents of fluid transfer unit body 121, and / or as finding the position of piston 123 within fluid transfer unit body 121.

[0234] Gross geometry parameters are optionally useful in themselves as fluid transfer unit characteristics which are accounted for in selecting values of one or more parameters by which fluid transfer assembly 119 is manipulated. For example, the relative position of plunger 137 and fluid transfer unit body 121 is informative as to how much further plunger 137 may be advanced relative to fluid transfer unit body 121, and / or how much more plunger 137 may be withdrawn from fluid transfer unit body 121. One or both of these distances may be used to define a constraining range of motion, and targeted movements (e.g., to inject a certain volume or withdraw a certain volume) are optionally compared to the constraining range of motion to ensure that they are consistent with it. This status is optionally used to determine whether a corrective measure is needed, for example, one or more of: aborting manipulation of the fluid transfer unit, reducing the targeted distance of movement, and adjusting a plan for pharmaceutical preparation with respect to manipulation of an additional fluid transfer unit (e.g., a fluid transfer unit which makes up a deficit in volume which use of the current fluid transfer unit will result in).

[0235] In another example, a wall thickness of a fluid transfer unit 120 may be used as a characteristic which associated with a reliability limit on maximum pressure which may be applied to fluid transfer unit 120 during its operation. In another example, an inner diameter of fluid transfer unit 120 (e.g., outer diameter minus twice the wall thickness) is optionally indicative of volume transferred per length unit of movement of plunger 137, which may be used to determine how much plunger 137 should be moved.

[0236] Images of fluid transfer assembly 119 obtained before, during, or after manipulation of fluid transfer assembly 119 are optionally subjected to image processing to help detect adverse and / or abnormal conditions, and / or to verify that such conditions are absent. In one group of examples, positioning of fluid transfer assembly 119 with respect to some (e.g., either targeted or incorrect) position state is checked. More particular examples of this include states of engagement, e.g., with gripper 130, plunger arm 125, and / or fluid transfer connector 126. Other more particular examples include detection of the positioning and / or configuration of fluid transfer assembly 119 (e.g., within a fluid transfer assembly depot 100 such as a fluid transfer assembly carousel), used to plan movements of gripper 130 and / or plunger arm 125 to engage fluid transfer assembly 119, and / or verify the correctness of planned movements. Another example of this type is verification that an expected position of plunger 137 relative to fluid transfer unit body 121 (e.g., expected based on previously given motion commands and / or encoder measurements) conforms with what is actually visible in the image.

[0237] In another group of examples, deformation of fluid transfer assembly 119 is checked. Causes of deformation include, for example, deformation due to pressure from gripper 130, and deformation due to a mismatch between pressure applied to plunger 137 and the rate at which fluid is able to flow out of fluid transfer unit body 121. Types of deformation include, for example, a bowing and / or twisting deformation of a shaft of a plunger, or a bulging deformation of a body of the fluid transfer unit.

[0238] Deformation (at least to some extent) may be routinely expected and / or indicative of correct functioning. Additionally or alternatively, deformation (e.g., excessive deformation) may be indicative of a fault or a potential for a fault occurring; for example, a blockage in flow, an incorrectly executed gripping diameter, and / or an incipient loss of containment integrity due to leakage and / or bursting.

[0239] Deformation is optionally detected and / or measured directly from single images, e.g., through the application of suitable image processing techniques, for example as listed in relation to fluid transfer unit identification. Additionally or alternatively, fluid transfer unit geometry measurement unit 375 determines fluid transfer unit deformation via methods such as machine learning classification. Optionally, special lighting (e.g., polarized light) is used to assist in deformation detection, e.g., by making use of stress induced birefringence.

[0240] In some examples, differential image processing is used to detect differences between, e.g., pressurized and un-pressurized states of fluid transfer unit 120, and / or states of fluid transfer assembly 119 before and during manipulation (and / or after a manipulation is performed). A potential advantage of differential and / or stress induced birefringence imaging methods is that they can be sensitive to potentially very small (e.g., sub-pixel level) deformations, especially at high-contrast boundary regions, such as at the wall of a fluid transfer unit 120 viewed against a contrasting background. Using methods sufficiently sensitive to deformation to detect deformation at levels associated with intended function of PPS 99 and fluid transfer assembly transporter 105 provides a potential advantage by generating data which can guide manipulations as they are performed. For example, rates of fluid transfer are optionally adjusted dynamically to maintain a level of distortion within an appropriate (e.g., validated for the fluid transfer unit type) range, without necessarily requiring de-rating (or with relatively reduced de-rating) of a maximum velocity of plunger 137 to account for unknown variabilities in fluid contents viscosity, fluid transfer unit 120 manufacture, or another source of variability.

[0241] In another group of examples, movements of fluid transfer unit 120 and / or of elements connected to fluid transfer unit 120 (such as fluid transfer connector 126) are detected using images obtained by imager(s) 240. Detection of these movements may be performed through the application of illumination and / or image analysis techniques, for example as described in relation to deformation detection. During manipulation of fluid transfer assembly 119, rotational and / or translation movements of certain elements (e.g., fluid transfer unit body 121 and / or fluid transfer connector 126) are potentially indicative of incorrect engagement with fluid transfer assembly transporter 105, and / or incorrectly configured attachment, e.g., of fluid transfer connector 126 to fluid transfer unit connecting end 122. It is a potential advantage to detect such movements, as they may be preliminary to fault conditions such as fluid leakage, and / or associated with leakage actually occurring.

[0242] In another group of examples, characteristics of a fluid transfer unit 120 associated with its fluid contents are detected and / or measured using images obtained by imager(s) 240. Detection of these movements may be performed through the application of illumination and / or image analysis techniques, for example as described in relation to deformation detection. More particular examples of this group include fluid leakage as such, which may manifest in the images in different forms, depending on the nature of the fault. For example, image analysis may reveal the presence of a fluid droplet, or a change in reflectance of a fluid transfer assembly 119 as a result of wetting. Optionally, one or more jet capture surfaces is placed in the vicinity of regions of particular concern (e.g., near connectors, the capture surface being configured to change contrast when wetted to allow ready detection of potentially more energetic leaks occurring when fluid transfer assembly 119 is under pressure. Methods of Operating Pharmaceutical Preparation Systems

[0243] Fluid Transfer Unit-Characteristic Dependent Modification of Fluid Transfer Unit Engagement

[0244] Reference is now made to Fig. 4A, which illustrates a flow diagram of an example method of gripping a fluid transfer unit by a gripper, the gripping being optimized for determined fluid transfer unit type data, according to some examples of the present disclosure. The method of Fig. 4A may be considered as an example of the method of Fig. 1A. In general, it should be understood that the operations of any of the methods of Figs. 4A- 4C are optionally performed together within a same PPS 99, and optionally performed together in any suitable combination during manipulation of a same fluid transfer assembly 119, optionally using at least some of the same images.

[0245] At block 410A, in some examples, processing circuitry 217 (for example: imager interface unit 355) accesses (e.g., receives) one or more images (e.g., digital images) of the fluid transfer assembly 119; for example: as captured by imager(s) 240 at imager distance 295. The specification of imager distance 295 (e.g., as a “particular distance”) relates to operations which are sensitive to focus and / or scale. Specific use of imager distance 295 is not necessarily made in all examples of the present disclosure; e.g., focus may be determined based on image spatial frequency content, and / or scale may be determined based on the size of a reference element depicted in the one or more images. For example, a scale marking may be placed alongside a fluid transfer assembly 119, and / or a scale marking on fluid transfer unit 120 itself of known size and / or spacing may be used in calculations.

[0246] At block 420A, in some examples, processing circuitry 217 (for example: fluid transfer unit identification unit 365) processes the one or more images to determine fluid transfer unit characteristics. By way of non-limiting example: processing circuitry 217 (for example: fluid transfer unit identification unit 365) can utilize an image processing method such as line detection or machine learning (and / or another image processing method, for example as described in relation to Fig. 1A and / or Fig. 3B) to determine fluid transfer unit characteristics. In some examples, the fluid transfer unit characteristics are generated and / or accessed in the form of a data structure comprising fluid transfer unit model data (e.g., fluid transfer unit body length, thickness, circumference, manufacturer, and / or model number).

[0247] At block 430A, in some examples, processing circuitry 217 and / or gripping control unit 335, control gripper 130 to grip the fluid transfer unit using a gripper jaw diameter and / or at a body location that is selected in accordance with the determined fluid transfer unit characteristics (e.g., fluid transfer unit model data, or another data form representing the fluid transfer unit characteristics).

[0248] By way of non-limiting example: as described above, a preferred placement of gripper along the fluid transfer unit body optionally depends on one or more fluid transfer unit characteristics; for example, fluid transfer unit length, circumference, manufacturer, and / or another consideration. Accordingly, in some examples, processing circuitry 217 and / or gripping control unit 335 controls gripper 130 to position it at a particular location along the fluid transfer unit body 121 that is in accordance with the fluid transfer unit characteristics (e.g., fluid transfer unit model data).

[0249] By way of further non-limiting example: as described above, a preferred gripper jaw diameter to be used by gripper 130 along the fluid transfer unit body 121 optionally depends on one or more fluid transfer unit characteristics; for example, fluid transfer unit length, circumference, manufacturer, and / or another consideration. Accordingly, in some examples, processing circuitry 217 (for example, by giving commands to gripping control unit 335) controls gripper 130 to grip using a particular gripper jaw diameter value that is in accordance with the fluid transfer unit characteristics (e.g., fluid transfer unit model data). For example, the gripper jaw diameter value may be selected as a value which is equal to or slightly adjusted relative to a diameter of the fluid transfer assembly 119 at the location being gripped. Smaller values may be used, e.g., to help ensure a tight grip, allowing for a certain amount of compression. Equal or larger values may be more suitable for a fluid transfer assembly 119 comprised of a relatively incompressible material, and / or where fluid transfer assembly 119 is restrained primarily by its shape (e.g., a widening of fluid transfer unit connecting end 122 below the gripping location used by gripper 130), rather than by friction.

[0250] It should be understood that the method of Fig. 4A is representative of a class of methods relating to engagement of a fluid transfer assembly 119 by fluid transfer assembly transporter 105. For example, the example of Fig. 4A relates to values for parameters related to operation of gripper 130. It should be understood that the same group of operations, changed as appropriate, is optionally performed for values for parameters related to operation of plunger arm 125 as it engages a plunger 137 of a fluid transfer unit 120, and / or operation of fluid transfer assembly transporter 105 itself, e.g., related to its positioning relative to a fluid transfer assembly 119 held in a fluid transfer assembly depot 100, for example a linear- or carouseltype fluid transfer assembly depot 100. Fluid Transfer Unit-Characteristic Dependent Modification of Plunger Operations

[0251] Reference is now made to Fig. 4B, which illustrates a flow diagram of an example method of drawing fluid into a fluid transfer unit or injecting fluid from a fluid transfer unit, the drawing or injecting being selected according to one or more determined fluid transfer unit characteristics, according to some examples of the present disclosure. In some examples, the determined fluid transfer unit characteristics are determined using fluid transfer unit type data. In some examples, the determined fluid transfer unit characteristics are determined using fluid transfer unit measurements (e.g., measurements of a specific fluid transfer assembly 119, not necessarily making reference to a particular type of the fluid transfer assembly 119. The method of Fig. 4B may be considered as an example of the method of Fig. 1A, with the operations of block 430B being one example of operations corresponding to block 54, and the operations of block 440B being another example of operations corresponding to block 54.

[0252] At block 410B, in some examples, processing circuitry 217 (for example: imager interface unit 355) accesses one or more images of the fluid transfer unit; for example, one or more images captured by imager(s) 240 at imager distance 295. Descriptions of imager distance 295 in relation to block 410A of Fig. 4A should be understood as applying to block 410B as well.

[0253] At block 420B, in some examples, processing circuitry 217 (for example: fluid transfer unit identification unit 365) processes the image(s) of block 410B to determine fluid transfer unit characteristics, e.g., in the form of fluid transfer unit model data or in another form. By way of non-limiting example: Processing circuitry 217 (for example: fluid transfer unit identification unit 365) optionally utilizes any suitable image processing method (e.g., as described in relation to Fig. 1A and / or Fig. 3B), and / or machine learning to determine fluid transfer unit characteristics. Fluid transfer unit characteristics may be determined, for example, using measurements based on the image(s), and / or using fluid transfer unit model data describing one or more fluid transfer unit characteristics such as fluid transfer unit body length, thickness, circumference, manufacturer, and / or model number.

[0254] At block 430B, in some examples, processing circuitry 217 and / or plunger arm control unit 345 controls plunger arm 125 to move fluid transfer unit plunger 137 a particular distance into or out of fluid transfer unit body 121, with the velocity of the plunger being optimized in accordance with the determined fluid transfer unit model data.

[0255] By way of non-limiting example: as described above, a preferred velocity of plunger movement optionally depends on any one or more fluid transfer unit characteristics; for example, fluid transfer unit length, circumference (diameter), manufacturer, or another consideration. In some examples, processing circuitry 217 and / or plunger arm control unit 345 determines a target velocity from a table or other data structure associating fluid transfer unit types and / or fluid transfer unit geometry with appropriate values of target velocity. Additionally or alternatively, processing circuitry 217 and / or plunger arm control unit 345 determines a target velocity via another mechanism (such as machine learning classification). In some examples, processing circuitry 217 and / or plunger arm control unit 345 further utilize viscosity of the fluid being drawn in order to determine the target velocity, e.g., as provided as a further data input, and / or as determined empirically, e.g., by test manipulation of the fluid transfer assembly 119 being manipulated, and / or an example fluid transfer assembly 119, e.g., a fluid transfer assembly 119 filled with a fluid considered representative, in its viscosity, of the contents of a plurality of other fluid transfer units 120.

[0256] At block 440B, in some examples, processing circuitry 217 and / or plunger arm control unit 345 optionally measure an actual effective push / pull velocity of fluid transfer unit plunger 137. For example, this velocity may be measured by obtaining a plurality of images, at times separated by a movement of plunger 137, and measuring from the images the distance of the movement. For example, an average velocity can be by performing image processing on successive images of the fluid transfer unit during a push / pull operation.

[0257] Additionally or alternatively, in some examples, processing circuitry 217 and / or plunger arm control unit 345 determine the actual average push / pull velocity by reading from registers 320B, e.g., as described in relation to Fig. 3A. In some examples, processing circuitry 217 and / or plunger arm control unit 345 receive image data indicative of the actual average push / pull velocity from imager controller 230.

[0258] Potentially, any one or more of several factors potentially result in an actual average velocity of plunger motion lower that a targeted (and commanded) velocity. These factors include, for example, viscosity of the fluid being drawn / injected, thickness of a connector septum 131, or another factor. Potentially, a value characterizing one or more of these factors is available as a fluid transfer unit characteristic, e.g., a fluid transfer unit characteristic associated with a particular fluid transfer unit type.

[0259] Optionally, if it is determined at block 440B that the actual average push / pull velocity of fluid transfer unit plunger 137 does not match the target velocity (e.g., it is lower than the target velocity by a certain threshold), then processing circuitry 217 and / or plunger arm control unit 345 can, for example, optionally reduce the target velocity to match the effective velocity, halt operations manipulating the fluid transfer assembly 119, and / or produce a message signal such as a warning or alert (as text, graphical indication, and / or sound, for example).

[0260] Fluid Transfer Unit Attachment Monitoring

[0261] Reference is now made to Fig. 4C, which illustrates a flow diagram of an example method of determining whether a fluid transfer connector is correctly attached to a fluid transfer unit, utilizing one or more determined fluid transfer unit characteristics, according to some examples of the present disclosure. In some examples, the determined fluid transfer unit characteristics are determined using fluid transfer unit type data. In some examples, the determined fluid transfer unit characteristics are determined using fluid transfer unit measurements (e.g., measurements of a specific fluid transfer assembly 119, not necessarily making reference to a particular type of the fluid transfer assembly 119. The method of Fig. 4C may be considered as an example of the method of Fig. 1A, with the operations of blocks 430C and 440C together providing an example of operations corresponding to block 54.

[0262] At block 410C, in some examples, processing circuitry 217 (for example: imager interface unit 355) accesses one or more images of the fluid transfer unit; for example, one or more images captured by imager(s) 240 at imager distance 295. Descriptions of imager distance 295 in relation to block 410A of Fig. 4A should be understood as applying to block 410B as well.

[0263] At block 420C, in some examples, processing circuitry 217 (for example: fluid transfer unit identification unit 365) processes the image(s) of block 410C to determine fluid transfer unit characteristics, e.g., in the form of fluid transfer unit model data or in another form. By way of non-limiting example: Processing circuitry 217 (for example: fluid transfer unit identification unit 365) optionally utilizes any suitable image processing method (e.g., as described in relation to Fig. 1A and / or Fig. 3B), and / or machine learning to determine fluid transfer unit characteristics. Fluid transfer unit characteristics may be determined, for example, using measurements based on the image(s), and / or using fluid transfer unit model data describing one or more fluid transfer unit characteristics such as fluid transfer unit body length, thickness, circumference, manufacturer, and / or model number.

[0264] At block 430C, in some examples, processing circuitry 217 and / or fluid transfer unit identification unit 365 determines, from the digital image, a length of a portion of a cannula of the fluid transfer assembly 119 (e.g., a needle of fluid transfer assembly 119), a position of a plunger 137, and / or a position of a piston 123. The length and / or position determined is indicative of an available range of motion of plunger 137; e.g., an amount of fluid which is available to be injected from fluid transfer unit 120, and / or an amount of volume which available to be filled in fluid transfer unit 120 from a fluid container 175 such as a vial 115 or IV bag 116.

[0265] In some examples, for example, the length of exposed cannula is a length of exposed metal extending beyond the fluid transfer unit connecting end 122 through a fluid transfer connector 126, or optionally the portion of this length of exposed cannula extending beyond the fluid transfer connector 126 itself.

[0266] Processing circuitry 217 (for example: fluid transfer unit identification unit 365) compares the determined length and / or position with a threshold value for position. For example, in the case of the cannula, the threshold value is indicative of how much metal should be exposed if the fluid transfer connector is correctly attached to the fluid transfer unit. This threshold value can be derivative of, or otherwise in accordance with the determined fluid transfer unit characteristics; e.g., an appropriate length of exposed cannula optionally varies according to fluid transfer unit type.

[0267] At block 440C, in some examples, if the determined length is outside of a limit set by the threshold, it is an indication that the fluid transfer connector 126 is improperly attached to the fluid transfer unit 120. Optionally, processing circuitry 217 (for example: syringe identification unit 365) provides a signal leading to appropriate handling of this condition, e.g., raising an alert.

[0268] General

[0269] As used herein with reference to quantity or value, the term “about” means “within ±10% of’.

[0270] The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean: “including but not limited to”.

[0271] The term “consisting of’ means: “including and limited to”.

[0272] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0273] As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof. The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “example” or “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0274] The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the present disclosure may include a plurality of “optional” features except insofar as such features conflict.

[0275] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0276] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0277] Throughout this application, embodiments may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of descriptions of the present disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc. as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0278] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween. Although descriptions of the present disclosure are provided in conjunction with specific embodiments, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0279] It is appreciated that certain features which are, for clarity, described in the present disclosure in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the present disclosure. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0280] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS :

1. A fluid transfer assembly-manipulation subsystem of a pharmaceutical preparation system (PPS), the subsystem comprising: a gripper, configured to grip a fluid transfer assembly; a fluid pump, which operates to urge transfer of fluid into or out of the fluid transfer assembly according to a pressure exerted by the fluid pump, while the fluid transfer assembly is gripped by the gripper; and processing circuitry including a processor and memory, the memory storing instructions which instruct the processor to: access at least one image of the fluid transfer assembly; process the image to determine at least one characteristic of the fluid transfer assembly, and command at least one of the gripper and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one respective operating parameter; wherein the at least one value of the at least one respective operating parameter is selected according to the determined at least one characteristic.

2. The fluid transfer assembly-manipulation subsystem of claim 1, comprising at least one imager positioned to image the fluid transfer assembly while the gripper is engaged with the fluid transfer assembly; and wherein the at least one image of the fluid transfer assembly is imaged by the at least one imager.

3. The fluid transfer assembly-manipulation subsystem of claim 2, comprising an illumination source which lights the fluid transfer assembly from an angle adjustable among images while the at least one imager images the at least one image of the fluid transfer assembly.

4. The fluid transfer assembly-manipulation subsystem of any one of claims 2-3, comprising an illumination source which illuminates the fluid transfer assembly with structured light while the at least one imager images the at least one image of the fluid transfer assembly.

5. The fluid transfer assembly-manipulation subsystem of any one of claims 2-4, wherein the at least one imager images the fluid transfer assembly in at least two different positions to produce the at least one image.

6. The fluid transfer assembly-manipulation subsystem of any one of claims 2-4, wherein the at least one imager images the fluid transfer assembly from at least two different positions to produce the at least one image.

7. The fluid transfer assembly-manipulation subsystem of any one of claims 2-6, wherein at least one image comprises a plurality of images, and the processing circuitry uses a differential image produced using the plurality of images to determine the at least one characteristic of the fluid transfer assembly.

8. The fluid transfer assembly-manipulation subsystem of any one of claims 2-7, comprising an illumination source which back-lights the fluid transfer assembly from the perspective of the at least one imager while the at least one imager images the at least one image of the fluid transfer assembly.

9. The fluid transfer assembly-manipulation subsystem of any one of claims 1-4, wherein, when processing the image, the processing circuitry: uses the at least one image to determine a type of the fluid transfer assembly; selects fluid transfer assembly model data, using the type; and uses the selected fluid transfer assembly model data to determine the at least one characteristic.

10. The fluid transfer assembly-manipulation subsystem of claim 9, wherein, when processing the image, the processing circuitry determines the type using machine learning-based classification of the image.

11. The fluid transfer assembly-manipulation subsystem of any one of claims 9- 10, wherein, when processing the image, the processing circuitry determines the type using at least one of a fluid transfer assembly diameter and a fluid transfer assembly length determined using the at least one image.

12. The fluid transfer assembly-manipulation subsystem of any one of claims 9-11, wherein, when processing the image, the processing circuitry determines the type using an appearance in the at least one image of at least one of: scale markings on the fluid transfer assembly, logo markings on the fluid transfer assembly, and a pattern marked on the fluid transfer assembly encoding a digital value.

13. The fluid transfer assembly-manipulation subsystem of any one of claims 9-12, wherein, when processing the image, the processing circuitry determines the type using a geometrical shape appearing in the at least one image comprising at least one of: a shape of a piston of the fluid transfer assembly, a shape of a shaft of the fluid transfer assembly, a shape of an apex of a body of a fluid transfer unit of the fluid transfer assembly, and a shape of a flange of the body.

14. The fluid transfer assembly-manipulation subsystem of any one of claims 1- 10, wherein, when processing the image, the processing circuitry: uses the at least one image to measure a geometry of the fluid transfer assembly; generates fluid transfer assembly model data, using the measured geometry; and uses the generated fluid transfer assembly model data to determine the at least one characteristic.

15. The fluid transfer assembly-manipulation subsystem of any one of claims 9- 14, wherein, when processing the image, the processing circuitry determines the at least one value according to a table indexed by the fluid transfer assembly model data.

16. The fluid transfer assembly-manipulation subsystem of any one of claims 9- 14, wherein, when processing the image, the processing circuitry determines the at least one value according to machine learning classification of the fluid transfer assembly model data.

17. The fluid transfer assembly-manipulation subsystem of any one of claims 1- 16, wherein the at least one characteristic comprises a diameter of the fluid transfer assembly,and the at least one operating parameter comprises a corresponding gripping diameter of the gripper.

18. The fluid transfer assembly-manipulation subsystem of any one of claims 1- 17, wherein: the at least one characteristic comprises a shape of the fluid transfer assembly; and the at least one operating parameter comprises a respective targeted gripping position for the gripper along the fluid transfer assembly.

19. The fluid transfer assembly-manipulation subsystem of any one of claims 1-18 wherein: the at least one characteristic comprises a designated gripping location of the fluid transfer assembly; and the at least one operating parameter comprises a gripping position of the fluid transfer assembly targeting the designated gripping location.

20. The fluid transfer assembly-manipulation subsystem of any one of claims 1- 19, wherein the fluid pump comprises a plunger arm, configured to move a plunger of the fluid transfer assembly while gripped.

21. The fluid transfer assembly-manipulation subsystem of claim 20, wherein: the at least one characteristic comprises a relative position of a body of a fluid transfer unit of the fluid transfer assembly and the plunger; and the processor is instructed to use the relative position in at least one of: controlling transfer of a fluid using the fluid transfer assembly, and verifying said transfer.

22. The fluid transfer assembly-manipulation subsystem of claim 21, wherein the at least one operating parameter comprises a targeted connecting position of the plunger arm to the plunger.

23. The fluid transfer assembly-manipulation subsystem of any one of claims 21- 22, wherein the at least one operating parameter comprises a targeted linear distance movedby the plunger while connected to the plunger arm, the targeted linear distance being determined in accordance with a targeted volume of the fluid to be transferred.

24. The fluid transfer assembly-manipulation subsystem of any one of claims 21- 23, wherein the at least one characteristic comprises a constraining range of allowed relative positions of a body of a fluid transfer unit of the fluid transfer assembly and the plunger, selected to be consistent with an available range of motion of the plunger relative to the body; and the instructions instruct the processor to: access a targeted linear distance of movement of the plunger relative to the body; and determine a status indicating whether the targeted linear distance of movement is consistent with both: the relative position of the body and the plunger, and the constraining range of allowed relative positions of the body and the plunger.

25. The fluid transfer assembly-manipulation subsystem of claim 24, wherein, when the status indicates inconsistency, the processor is instructed to perform at least one of: abort manipulation of the fluid transfer assembly, reduce the targeted linear distance, and adjust a plan for pharmaceutical preparation with respect to manipulation of an additional fluid transfer assembly.

26. The fluid transfer assembly-manipulation subsystem of any one of claims 20- 25, wherein the at least one characteristic determined from the at least one image of the fluid transfer assembly comprises a resistance to flow associated with the fluid transfer assembly; and the instructions instruct the processor to: access a value indicative of a viscosity of a fluid being transferred using the fluid transfer assembly; and determine a targeted velocity of linear movement of the plunger relative to a body of a fluid transfer unit of the fluid transfer assembly; wherein the targeted velocity is determined in accordance with the value indicative of the viscosity of the fluid and the resistance to flow of the fluid transferassembly, and in accordance with an upper limit on pressures generated within the fluid transfer assembly during the linear movement of the plunger.

27. The fluid transfer assembly-manipulation subsystem of claim 26, wherein the at least one characteristic comprises an upper pressure rating of the fluid transfer assembly, and the upper limit on pressures is determined according to the upper pressure rating.

28. The fluid transfer assembly-manipulation subsystem of claim 26, wherein the at least one characteristic comprises a targeted operating pressure of the fluid transfer assembly, and the targeted velocity of linear movement of the fluid transfer assembly is determined according to the targeted operating pressure.

29. The fluid transfer assembly-manipulation subsystem of any one of claims 26- 27, wherein: the instructions instruct the processor to access a vapor pressure of the fluid being transferred using the fluid transfer assembly; and the targeted velocity is further determined in accordance with the vapor pressure of the fluid, in accordance with lower limit on pressures generated within the fluid transfer assembly during the linear movement of the plunger.

30. The fluid transfer assembly-manipulation subsystem of any one of claims 1-29, including a fluid transfer assembly transporter configured to engage fluid transfer assemblies with the fluid transfer assembly -manipulation subsystem.

31. The fluid transfer assembly-manipulation subsystem of any one of claims 1-30, including a vial holder configured to position vials at one or more locations accessible to interconnection of held vials with fluid transfer assemblies manipulated by the fluid transfer assembly-manipulation subsystem.

32. The fluid transfer assembly-manipulation subsystem of any one of claims 1-31, wherein: the at least one image comprises at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly by the fluid transfer assembly-manipulation subsystem; andthe processor adjusts the at least one operating parameter from an initial value to an adjusted value based on the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly.

33. The fluid transfer assembly-manipulation subsystem of claim 32, wherein: the processing circuitry scans the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly for detection of one or more adverse conditions; and upon detection, produces a signal indicative of the one or more adverse conditions.

34. The fluid transfer assembly-manipulation subsystem of claim 33, wherein the one or more adverse conditions scanned for comprise at least one of: rotation of a body of a fluid transfer unit of the fluid transfer assembly; movement of the body along a longitudinal axis of the body, a change in shape of the body, and a change in shape of a plunger of the fluid transfer unit.

35. The fluid transfer assembly-manipulation subsystem of claim 34, wherein the one or more adverse conditions scanned for comprise at least one of the changes in shape, determined using comparison of the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly with a baseline image.

36. The fluid transfer assembly-manipulation subsystem of claim 33, wherein the fluid transfer assembly comprises a fluid transfer connector attached to a fluid transfer unit during movement of a plunger of the fluid transfer unit, and the one or more adverse conditions scanned for comprise at least one of: an incorrect amount of visible length of a portion of a body of the fluid transfer unit; an incorrect distance of a portion of the body from a portion of the fluid transfer connector, a relative movement of the body and the fluid transfer connector, and fluid leakage in associated with a junction between the body and the fluid transfer connector.

37. The fluid transfer assembly-manipulation subsystem of any one of claims 33-36, including the PPS, wherein the PPS produces an alert upon receiving the signal.

38. The fluid transfer assembly-manipulation subsystem of any one of claims 32-37, wherein the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly by the fluid transfer assembly -manipulation subsystem indicates a linear velocity of a plunger different than a targeted velocity of the plunger.

39. A method of configuring a fluid transfer assembly-manipulation subsystem of a pharmaceutical preparation system (PPS), the fluid transfer assembly -manipulation subsystem including a gripper, configured to grip the fluid transfer assembly, and a fluid pump which operates to urge transfer of fluid into or out of the fluid transfer assembly according to a pressure exerted by the pump, while the fluid transfer assembly is gripped; and wherein the method comprises: determining, by processing circuitry, at least one characteristic of the fluid transfer assembly, using at least one image of the fluid transfer assembly; and commanding at least one of the gripper and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one respective operating parameter; wherein the at least one value of the at least one respective operating parameter is selected according to the determined at least one characteristic.

40. The method of claim 39, comprising acquiring the image using an imager.

41. The method of any one of claims 39-40, comprising: determining a type of the fluid transfer assembly, using the at least one image; selecting fluid transfer assembly model data, using the type; and using the selected fluid transfer assembly model data to determine the at least one characteristic.

42. The method of claim 41, wherein the determining the type comprises measuring at least one of a fluid transfer assembly diameter and a fluid transfer assembly length using the least one image.

43. The method of any one of claims 41-42, wherein the determining uses an appearance in the at least one image of at least one of: scale markings on the fluid transfer assembly, logo markings on the fluid transfer assembly, and a pattern marked on the fluid transfer assembly encoding a digital value.

44. The method of any one of claims 41-43, wherein the determining uses a geometrical shape appearing in the at least one image comprising at least one of: a shape of a piston of the fluid transfer assembly, a shape of a shaft of the fluid transfer assembly, a shape of an apex of a body of a fluid transfer unit of the fluid transfer assembly, and a shape of a flange of the body.

45. The method of any one of claims 39-41, wherein the determining at least one characteristic comprises: measuring a geometry of the fluid transfer assembly using the at least one image; generating fluid transfer assembly model data, using the measured geometry; and using the generated fluid transfer assembly model data to determine the at least one characteristic.

46. The method of any one of claims 39-45, wherein the fluid pump comprises a plunger arm, and the commanding commands movement of a plunger of the fluid transfer assembly while gripped.

47. The method of claim 46, wherein: the at least one characteristic comprises a relative position of a body of a fluid transfer unit of the fluid transfer assembly and the plunger; and comprising using the relative position in at least one of: controlling transfer of a fluid using the fluid transfer assembly, and verifying said transfer.

48. The method of claim 47, wherein the at least one characteristic comprises a constraining range of allowed relative positions of a body of a fluid transfer unit of the fluidtransfer assembly and the plunger, selected to be consistent with an available range of motion of the plunger relative to the body; and the method comprises: accessing a targeted linear distance of movement of the plunger relative to the body; and determining a status indicating whether the targeted linear distance of movement is consistent with both: the relative position of the body and the plunger, and the constraining range of allowed relative positions of the body and the plunger.

49. The method of any one of claims 46-48, wherein the at least one characteristic determined from the at least one image of the fluid transfer assembly comprises a resistance to flow associated with the fluid transfer assembly; and the method comprises: accessing a value indicative of a viscosity of a fluid being transferred using the fluid transfer assembly; and determining a targeted velocity of linear movement of the plunger relative to a body of a fluid transfer unit of the fluid transfer assembly, said determining being: in accordance with the value indicative of the viscosity of the fluid and the resistance to flow of the fluid transfer assembly, and in accordance with an upper limit on pressures generated within the fluid transfer assembly during the linear movement of the plunger.

50. A computer program product comprising a computer-readable non-transitory storage medium containing program instructions, which said program instructions, when read by a processor, cause the processing circuitry to perform a method of configuring fluid transfer assembly manipulation in a pharmaceutical preparation system (PPS), the fluid transfer assembly-manipulation subsystem including a gripper configured to grip the fluid transfer assembly, and a fluid pump which operates to urge transfer of fluid into or out of the fluid transfer assembly according to a pressure exerted by the fluid pump, while the fluid transfer assembly is gripped; and wherein the method comprises: determining, by processing circuitry, at least one characteristic of the fluid transfer assembly, using an image of the fluid transfer assembly; andcommanding at least one of the gripper and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one respective operating parameter; wherein the at least one value of the at least one respective operating parameter is selected according to the determined at least one characteristic.

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