Syringe optimized robotic drug preparation

Abstract

An image-guided syringe manipulation subsystem for a drug preparation system (PPS) is provided. A syringe is engaged by a gripper and a plunger arm, allowing syringe plunger movement by relative movement of the gripper and the plunger arm. Processing circuitry acquires one or more images of the syringe to determine one or more of its characteristics (e.g., its type and / or geometric measurements). A value of at least one operating parameter controlling how to manipulate the syringe is then determined as a function of the determined one or more characteristics.

Description

[0001] Related applications

[0002] This application claims the benefit of priority to 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.

[0003] Technical Field and Background

[0004] The presently disclosed subject matter relates to the field of robotic preparation of medications, and more particularly, but not exclusively, to operations involving the manipulation of fluid transfer units such as syringes.

[0005] The implementation problems of drug preparation automation have been recognized in the conventional art, and various techniques have been developed to provide solutions. Summary of the Invention

[0006] According to one aspect of some examples of the present disclosure, a fluid transfer assembly manipulation subsystem of a drug preparation system (PPS) is provided, the subsystem comprising: a clamp configured to clamp a fluid transfer assembly; a fluid pump that operates according to pressure applied by the fluid pump to cause fluid to be transferred into or out of the fluid transfer assembly when the fluid transfer assembly is clamped by the clamp; and a processing circuit system comprising a processor and a memory, the memory storing instructions that instruct the processor to: acquire 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 clamp and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one corresponding operating parameter; wherein the at least one value of the at least one corresponding operating parameter is selected based on at least one characteristic determined.

[0007] According to some examples of the present disclosure, the fluid transfer assembly manipulation subsystem includes at least one imager positioned to image the fluid transfer assembly when the clamp 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.

[0008] According to some examples of the present disclosure, the fluid transfer assembly manipulation subsystem includes an illumination source that illuminates the fluid transfer assembly from an angle that can be adjusted between images as the at least one imager images the at least one image of the fluid transfer assembly.

[0009] According to some examples of the present disclosure, the fluid transfer assembly manipulation subsystem includes an illumination source that 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.

[0010] 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 generate the at least one image.

[0011] 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 generate the at least one image.

[0012] According to some examples of the present disclosure, at least one image includes a plurality of images, and the processing circuitry determines the at least one characteristic of the fluid transfer assembly using a difference image generated using the plurality of images.

[0013] According to some examples of the present disclosure, the fluid transfer assembly manipulation subsystem includes an illumination source that backlights the fluid transfer assembly from an angle of the at least one imager as the at least one imager images the at least one image of the fluid transfer assembly.

[0014] According to some examples of the present disclosure, when processing the images, the processing circuit system: uses the at least one image to determine the type of the fluid transfer assembly; uses the type to select fluid transfer assembly model data; and uses the selected fluid transfer assembly model data to determine the at least one characteristic.

[0015] According to some examples of the present disclosure, when processing the image, the processing circuit system uses a machine learning-based classification of the image to determine the type.

[0016] According to some examples of the present disclosure, when processing the images, 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.

[0017] According to some examples of the present disclosure, when processing the image, the processing circuit system uses the appearance of at least one of the following in the at least one image to determine the type: a scale marking on the fluid transfer assembly; a logo marking on the fluid transfer assembly; and a pattern marked on the fluid transfer assembly that encodes a digital value.

[0018] According to some examples of the present disclosure, when processing the images, the processing circuit system uses geometric shapes appearing in the at least one image to determine the type, the geometric shapes including at least one of: the shape of the piston of the fluid transfer assembly; the shape of the shaft of the fluid transfer assembly; the shape of the vertex of the body of the fluid transfer unit of the fluid transfer assembly; and the shape of the flange of the body.

[0019] According to some examples of the present disclosure, when processing the images, the processing circuit system: 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 determines the at least one characteristic using the generated fluid transfer assembly model data.

[0020] According to some examples of the present disclosure, when processing the image, the processing circuitry determines the at least one value from 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 based on a 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 clamping diameter of the clamp.

[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 corresponding target gripping position of the gripper along the fluid transfer assembly.

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

[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 when clamped.

[0026] According to some examples of the present disclosure, the at least one characteristic includes the relative positioning of the body of the fluid transfer unit of the fluid transfer assembly and the plunger; and the processor is instructed to use the relative positioning when at least one of: controlling the transfer of 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 target connection position of the plunger arm relative to the plunger.

[0028] According to some examples of the present disclosure, the at least one operating parameter includes a target linear distance moved by the plunger when connected to the plunger arm, the target linear distance being determined based on a target volume of the fluid to be delivered.

[0029] According to some examples of the present disclosure, the at least one characteristic includes a constrained range of allowable relative positioning of the body of the fluid transfer unit of the fluid transfer assembly and the plunger, and the constrained range of allowable relative positioning is selected to be consistent with the available range of motion of the plunger relative to the body; and the instructions instruct the processor to: obtain a target linear movement distance of the plunger relative to the body; and determine a state indicating whether the target linear movement distance is consistent with the following two: the relative positioning of the body and the plunger; and the constrained range of allowable relative positioning of the body and the plunger.

[0030] According to some examples of the present disclosure, when the status indications are inconsistent, the processor is instructed to perform at least one of: suspending manipulation of the fluid transfer assembly; reducing the target linear distance; and adjusting a plan for drug preparation relative to manipulation of another fluid transfer assembly.

[0031] According to some examples of the present disclosure, the at least one characteristic determined based on the at least one image of the fluid transfer assembly includes a flow resistance associated with the fluid transfer assembly; and the instructions instruct the processor to: obtain a value indicating the viscosity of the fluid transferred using the fluid transfer assembly; and determine a target speed for the linear movement of the plunger relative to the body of the fluid transfer unit of the fluid transfer assembly; wherein the target speed is determined based on the value indicating the viscosity of the fluid and the flow resistance of the fluid transfer assembly, and based on an upper limit of the pressure generated within the fluid transfer assembly during the linear movement of the plunger.

[0032] 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 pressure limit is determined according to the upper pressure rating.

[0033] According to some examples of the present disclosure, the at least one characteristic includes a target operating pressure of the fluid transfer assembly, and the target speed of the linear movement of the fluid transfer assembly is determined according to the target operating pressure.

[0034] According to some examples of the present disclosure, the instructions instruct the processor to obtain the vapor pressure of the fluid transferred using the fluid transfer assembly; and the target speed is further determined based on the vapor pressure of the fluid and based on a lower limit of the pressure generated within the fluid transfer assembly during the linear movement of the piston.

[0035] According to some examples of the present disclosure, the fluid transfer assembly handling subsystem includes a fluid transfer assembly transporter configured to engage a fluid transfer assembly with the fluid transfer assembly handling subsystem.

[0036] According to some examples of the present disclosure, the fluid transfer assembly handling subsystem includes a vial holder configured to position a vial at one or more positions that enable the held vial to be interconnected with a fluid transfer assembly handled by the fluid transfer assembly handling subsystem.

[0037] 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.

[0038] According to some examples of the present disclosure, the processing circuit system scans the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly to detect one or more adverse conditions; and upon detection, generates a signal indicative of the one or more adverse conditions.

[0039] According to some examples of the present disclosure, the one or more adverse conditions scanned include at least one of the following: rotation of the body of the fluid transfer unit of the fluid transfer assembly; movement of the body along the longitudinal axis of the body; shape change of the body; and shape change of the plunger of the fluid transfer unit.

[0040] According to some examples of the present disclosure, the one or more adverse conditions scanned include at least one of the shape changes, which is determined using a comparison of the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly with a baseline image.

[0041] According to some examples of the present disclosure, the fluid transfer assembly includes a fluid transfer connector that is attached to the fluid transfer unit during movement of a plunger of the fluid transfer unit, and the one or more adverse conditions scanned include at least one of the following: an incorrect amount of visible length of a portion of the body of the fluid transfer unit; an incorrect distance between a portion of the body and a portion of the fluid transfer connector; relative movement of the body and the fluid transfer connector; and fluid leakage associated with a junction between the body and the fluid transfer connector.

[0042] According to some examples of the present disclosure, the PPS generates an alarm upon receiving the signal.

[0043] 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 the plunger that is different than a target velocity of the plunger.

[0044] According to one aspect of some examples of the present disclosure, a method is provided for configuring a fluid transfer assembly manipulation subsystem of a drug preparation system (PPS), the fluid transfer assembly manipulation subsystem comprising a clamp and a fluid pump, the clamp being configured to clamp a fluid transfer assembly, the fluid pump operating according to a pressure applied by the pump when the fluid transfer assembly is clamped to cause fluid to be transferred into or out of the fluid transfer assembly; and wherein the method comprises: determining, by a processing circuit system, at least one characteristic of the fluid transfer assembly using an image of the fluid transfer assembly; and commanding at least one of the clamp and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one corresponding operating parameter; wherein the at least one value of the at least one corresponding operating parameter is selected according to the determined at least one characteristic.

[0045] According to some examples of the present disclosure, the method includes acquiring the image using an imager.

[0046] 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 determining the at least one characteristic using the selected fluid transfer assembly model data.

[0047] According to some examples of the present disclosure, determining the type includes measuring at least one of a fluid transfer assembly diameter and a fluid transfer assembly length using the at least one image.

[0048] According to some examples of the present disclosure, the determining uses the appearance in the at least one image of at least one of: a scale marking on the fluid transfer assembly; a logo marking on the fluid transfer assembly; and a pattern marked on the fluid transfer assembly that encodes a digital value.

[0049] According to some examples of the present disclosure, the determination uses geometric shapes appearing in the at least one image, the geometric shapes including at least one of: a shape of a piston of the fluid transfer assembly; a shape of an axis of the fluid transfer assembly; a shape of a vertex of a body of a fluid transfer unit of the fluid transfer assembly; and a shape of a flange of the body.

[0050] According to some examples of the present disclosure, determining at least one characteristic includes: using the at least one image to measure a geometry of the fluid transfer assembly; generating fluid transfer assembly model data using the measured geometry; and determining the at least one characteristic using the generated fluid transfer assembly model data.

[0051] According to some examples of the present disclosure, the fluid pump includes a plunger arm, and the command commands movement of the plunger of the fluid transfer assembly when clamped.

[0052] According to some examples of the present disclosure, the at least one characteristic includes relative positioning of a body of a fluid transfer unit of the fluid transfer assembly and the plunger; and includes using the relative positioning in at least one of: controlling the transfer of fluid using the fluid transfer assembly; and verifying the transfer.

[0053] According to some examples of the present disclosure, the at least one characteristic includes a constraint range of allowable relative positioning of the body of the fluid transfer unit of the fluid transfer assembly and the plunger, and the constraint range of allowable relative positioning is selected to be consistent with the available range of motion of the plunger relative to the body; and the method includes: obtaining a target linear movement distance of the plunger relative to the body; and determining a state indicating whether the target linear movement distance is consistent with the following two: the relative positioning of the body and the plunger; and the constraint range of allowable relative positioning of the body and the plunger.

[0054] According to some examples of the present disclosure, the at least one characteristic determined based on the at least one image of the fluid transfer assembly includes a flow resistance associated with the fluid transfer assembly; and the method includes: obtaining a value indicating the viscosity of the fluid transferred using the fluid transfer assembly; and determining a target speed of linear movement of the plunger relative to the body of the fluid transfer unit of the fluid transfer assembly, the determination being based on the value indicating the viscosity of the fluid and the flow resistance of the fluid transfer assembly, and based on an upper limit of pressure generated within the fluid transfer assembly during the linear movement of the plunger.

[0055] According to one aspect of some examples of the present disclosure, a computer program product is provided, which includes a computer-readable non-transitory storage medium containing program instructions, which, when read by a processor, cause a processing circuit system to execute a method for configuring fluid transfer assembly manipulation in a drug preparation system (PPS), wherein the fluid transfer assembly manipulation subsystem includes a clamp and a fluid pump, wherein the clamp is configured to clamp the fluid transfer assembly, and the fluid pump operates according to the pressure applied by the fluid pump when the fluid transfer assembly is clamped to cause fluid to be transferred into or out of the fluid transfer assembly; and wherein the method includes: using an image of the fluid transfer assembly by the processing circuit system to determine at least one characteristic of the fluid transfer assembly; and commanding at least one of the clamp and the fluid pump to manipulate the fluid transfer assembly according to at least one value of at least one corresponding operating parameter; wherein the at least one value of the at least one corresponding operating parameter is selected based on the determined at least one characteristic.

[0056] According to one aspect of some examples of the present disclosure, a system for optimizing the handling of syringes in a drug preparation system (PPS) is provided, the system comprising a processing circuit system operably connected to a camera and a clamp, and the processing circuit system being configured to: i) receive a digital image of the syringe; ii) determine syringe model data based on the digital image using image processing technology; and iii) control the clamp to clamp the syringe at a determined clamping diameter, the determined clamping diameter being consistent with the syringe model data.

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

[0058] According to some examples of the present disclosure, the processing circuitry is further configured to determine the clamping diameter based on a table indexed by syringe model data.

[0059] According to some examples of the present disclosure, the processing circuit system is further configured to determine the clamping diameter through machine learning classification of syringe model data.

[0060] According to one aspect of some examples of the present disclosure, a system for optimizing the handling of syringes in a drug preparation system (PPS) is provided, the system comprising a processing circuit system operably connected to a camera and a clamp, the processing circuit system being configured to: i) receive a digital image of the syringe; ii) determine syringe model data based on the digital image using image processing technology; and iii) control the clamp to clamp the syringe barrel at a determined clamping position, the determined clamping position being consistent with the syringe model data.

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

[0062] According to some examples of the present disclosure, the processing circuitry is further configured to determine the clamping position based on a table indexed by syringe model data.

[0063] According to some examples of the present disclosure, the processing circuit system is further configured to determine the clamping position through machine learning classification of the syringe model data.

[0064] According to one aspect of some examples of the present disclosure, a system for optimizing the handling of syringes in a drug preparation system (PPS) is provided, the system comprising a processing circuit system operably connected to a camera and a syringe plunger arm, the processing circuit system comprising a processor and a memory, the processing circuit system being configured to: i) receive a digital image of the syringe; ii) determine syringe model data based on 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 consistent with at least: i. a volume of fluid to be transferred, and ii. the syringe model data.

[0065] According to some examples of the present disclosure, determining the syringe model data includes machine learning-based classification of the received image.

[0066] According to one aspect of some examples of the present disclosure, a system for optimizing the handling of syringes in a drug preparation system (PPS) is provided, the system comprising a processing circuit system operably connected to a camera and a syringe plunger arm, the processing circuit system being configured to: i) receive a digital image of the syringe; ii) determine syringe model data based on the digital image using image processing techniques; and iii) control the syringe plunger arm to move the syringe plunger at a determined speed, the determined speed being associated with the syringe model.

[0067] According to some examples of the present disclosure, the determined speed is further consistent with the viscosity of the fluid used for delivery.

[0068] According to some examples of the present disclosure, determining the syringe model data includes machine learning-based classification of the received image.

[0069] According to some examples of the present disclosure, the processing circuitry is further configured to determine the clamping position based on a table indexed by syringe model data.

[0070] According to some examples of the present disclosure, the processing circuit system is further configured to determine the clamping position through machine learning classification of the syringe model data.

[0071] According to one aspect of some examples of the present disclosure, a system for optimizing the handling of syringes in a drug preparation system (PPS) is provided, the system comprising a processing circuit system operably connected to a camera, the processing circuit system being configured to: i) receive a digital image of the syringe; ii) determine syringe model data based on the digital image using image processing techniques; iii) determine a length of an exposed portion of the sleeve of the syringe based on the digital image, wherein the exposed portion is located below a syringe connector; iv) compare the determined length of the exposed portion with a threshold length, wherein the threshold length is consistent with the syringe model data, thereby generating data indicating whether the syringe connector is correctly attached to the syringe; and v) issue an alarm in response to the syringe connector being incorrectly attached to the syringe.

[0072] According to one aspect of some examples of the present disclosure, a method based on a processing circuit system for optimizing the processing of a syringe in a drug preparation system (PPS) is provided, wherein the processing circuit system is operably connected to a camera and a clamp, and the method includes: i) receiving a digital image of the syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling the clamp to clamp the syringe at a determined clamping diameter, wherein the determined clamping diameter is consistent with the syringe model data.

[0073] According to one aspect of some examples of the present disclosure, a method based on a processing circuit system for optimizing the processing of a syringe in a drug preparation system (PPS) is provided, wherein the processing circuit system is operably connected to a camera and a clamp, and the method includes: i) receiving a digital image of the syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling the clamp to clamp the syringe barrel at a determined clamping position, wherein the determined clamping position is consistent with the syringe model data.

[0074] According to one aspect of some examples of the present disclosure, a method based on a processing circuit system for optimizing the processing of a syringe in a drug preparation system (PPS) is provided, wherein the processing circuit system is operably connected to a camera and a syringe plunger arm, and the method includes: i) receiving a digital image of the syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling the syringe plunger arm to move the syringe plunger a determined linear distance, wherein the determined linear distance is consistent with at least: i. the volume of fluid for transfer, and ii. the syringe model data.

[0075] According to one aspect of some examples of the present disclosure, a method based on a processing circuit system for optimizing the processing of a syringe in a drug preparation system (PPS) is provided, wherein the processing circuit system is operably connected to a camera and a syringe plunger arm, and the method includes: i) receiving a digital image of the syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling the syringe plunger arm to move the syringe plunger at a determined speed, wherein the determined speed is associated with the syringe model.

[0076] According to one aspect of some examples of the present disclosure, there is provided a method for optimizing the processing of a syringe in a drug preparation system (PPS) based on a processing circuit system, the processing circuit system being operably connected to a camera, the method comprising: i) receiving a digital image of a syringe; ii) determining syringe model data based on the digital image using image processing techniques; iii) determining a length of an exposed portion of a cannula of the syringe based on the digital image, wherein the exposed portion is located below a syringe connector; iv) comparing the determined length of the exposed portion with a threshold length, wherein the threshold length is consistent with the syringe model data, thereby generating data indicating whether the syringe connector is correctly attached to the syringe; and v) issuing an alarm in response to the syringe connector not being correctly attached to the syringe.

[0077] According to one aspect of some examples of the present disclosure, a computer program product is provided, which includes a computer-readable non-transitory storage medium containing program instructions, which, when read by a processor, causes a processing circuit system to execute a method for optimizing the processing of a syringe in a drug preparation system (PPS), the method comprising: i) receiving a digital image of a syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling a clamp to clamp the syringe at a determined clamping diameter, the determined clamping diameter being consistent with the syringe model data.

[0078] According to one aspect of some examples of the present disclosure, a computer program product is provided, comprising a computer-readable non-transitory storage medium containing program instructions, wherein the program instructions, when read by a processor, cause a processing circuit system to execute a method for optimizing the processing of a syringe in a drug preparation system (PPS), the method comprising: i) receiving a digital image of a syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling a clamp to clamp the syringe at a determined clamping position, wherein the determined clamping position is consistent with the syringe model data.

[0079] According to one aspect of some examples of the present disclosure, a computer program product is provided, comprising a computer-readable, non-transitory storage medium containing program instructions, which, when read by a processor, causes a processing circuit system to execute a method for optimizing the processing of a syringe in a drug preparation system (PPS), the method comprising: i) receiving a digital image of a syringe; ii) determining syringe model data based on the digital image using image processing techniques; and iii) controlling the syringe plunger arm to move the plunger of the syringe a determined linear distance, the determined linear distance being consistent with at least: i. a volume of fluid to be transferred, and ii. the syringe model data.

[0080] According to one aspect of some examples of the present disclosure, a computer program product is provided, comprising a computer-readable non-transitory storage medium containing program instructions, which, when read by a processor, causes a processing circuit system to execute a method for optimizing the processing of a syringe in a drug preparation system (PPS), the method comprising: i) receiving a digital image of a syringe; ii) determining syringe model data based on the digital image using image processing technology; and iii) controlling the syringe plunger arm to move the syringe plunger at a determined speed, the determined speed being associated with the syringe model.

[0081] According to one aspect of some examples of the present disclosure, a computer program product is provided, comprising a computer-readable, non-transitory storage medium containing program instructions, which, when read by a processor, causes a processing circuit system to execute a method for optimizing the processing of a syringe in a drug preparation system (PPS), the method comprising: i) receiving a digital image of a syringe; ii) determining syringe model data based on the digital image using image processing technology; iii) determining a length of an exposed portion of the sleeve of the syringe based on the digital image, wherein the exposed portion is located below a syringe connector; iv) comparing the determined length of the exposed portion with a threshold length, wherein the threshold length is consistent with the syringe model data, thereby generating data indicating whether the syringe connector is correctly attached to the syringe; and v) issuing an alarm in response to the syringe connector not being correctly attached to the syringe.

[0082] Unless otherwise specified, all technical and / or scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present disclosure pertains. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present disclosure, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification including definitions shall prevail. In addition, materials, methods, and examples are merely illustrative and are not intended to be necessarily restrictive.

[0083] As will be appreciated by those skilled in the art, aspects of the present disclosure may be embodied as a system, method or computer program product. Thus, aspects of the present disclosure may take the form of a complete hardware embodiment, a complete software embodiment (including firmware, resident software, microcode, etc.) or an embodiment that combines software and hardware aspects that may all be generally referred to herein as "circuits," "modules," or "systems" (e.g., methods may be implemented using "computer circuitry"). In addition, some embodiments of the present disclosure may take the form of a computer program product embodied in one or more computer-readable media having computer-readable program code embodied thereon. The implementation scheme of the method and / or system of some embodiments of the present disclosure may involve performing and / or completing selected tasks manually, automatically, or in combination thereof. In addition, according to the actual instruments and equipment of some embodiments of the method and / or system of the present disclosure, several selected tasks may be implemented, for example, using an operating system, by hardware, by software, or by firmware and / or by a combination thereof.

[0084] For example, the hardware for performing the selected tasks according to some embodiments of the present disclosure can be implemented as a chip or circuit. As software, the selected tasks according to some embodiments of the present disclosure can be implemented as multiple software instructions performed by a computer using any appropriate operating system. In some embodiments of the present disclosure, one or more tasks performed in the method and / or by the system are performed by a data processor (also referred to herein as a "digital processor", referring to a data processor using digital bit group operations), such as a computing platform for performing multiple instructions. The instruction execution element of the processor can include, for example, one or more microprocessor chips, ASICs and / or FPGAs. Optionally, the data processor includes volatile memory and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media for storing instructions and / or data. Optionally, a network connection is also provided. Optionally, a display and / or user input devices such as a keyboard or mouse are also provided. Any of these embodiments is more generally referred to as an example of a computer circuit system in this article.

[0085] Any combination of one or more computer-readable media may be used in some embodiments of the present disclosure. A 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, device, or apparatus, or any suitable combination of the foregoing. More specific examples (non-exhaustive list) of computer-readable storage media would include the following: an electrical connection having one or more wires, a portable computer disk, 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 conjunction with an instruction execution system, device, or apparatus. A computer-readable storage medium may also contain or store information for use by such a program, for example, data structured in a manner recorded on 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. In this article, computer-readable storage media that record data in a form that can be retrieved as digital byte groups are also referred to as digital memories. It should be understood that in some embodiments, where the computer-readable storage medium is not read-only in nature and / or is in a read-only state, the computer-readable storage medium is optionally also used as a computer-writable storage medium.

[0086] Herein, a data processor is referred to as being "configured" to perform data processing actions as long 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 for data) is specified by an instruction, the effect of which is that the processor operates according to the instruction. The action of processing can be referred to additionally or alternatively by one or more other terms; for example: compare, estimate, determine, calculate, identify, associate, store, analyze, select, and / or convert. 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 includes one or more of transmitting, storing, and / or presenting processing results. Presentation optionally includes showing on a display, indicating by sound, printing on a printout, or giving the result in a form acceptable to human sensory capabilities.

[0087] 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 electromagnetic, 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 conjunction with an instruction execution system, apparatus, or device.

[0088] 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.

[0089] The computer program code for performing the operation of some embodiments of the present disclosure can be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java, Smalltalk, C++ and conventional process programming languages ​​such as C programming language or similar programming languages. Additionally or alternatively, a sequence of logical operations (optionally logical operations corresponding to computer instructions) can be embodied in the design of ASIC and / or the configuration of FPGA devices. The program code can be executed entirely on the user's computer, partially on the user's computer (e.g., as an independent software package), partially on the user's computer and partially on a remote computer, or completely on a remote computer or server. In the latter case, the remote computer can be connected to the user's computer by any type of network including a local area network (LAN) or a wide area network (WAN), or an external computer can be connected (e.g., using an Internet service provider to connect via the Internet).

[0090] Some embodiments of the present disclosure may be described below with reference to the flowcharts and / or block diagrams of the methods, devices (systems) and computer program products according to the embodiments of the present disclosure. It should be understood that each box of the flowchart and / or block diagram and the combination of boxes in the flowchart and / or block diagram can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device create a device for implementing the function / action specified in one or more boxes of the flowchart and / or block diagram.

[0091] These computer program instructions may also be stored in a computer-readable medium, which may direct a computer, other programmable data processing device, or other apparatus to operate in a specific manner so that the instructions stored in the computer-readable medium produce an article of manufacture including instructions for implementing the functions / actions specified in one or more blocks of the flowchart and / or block diagram.

[0092] The computer program instructions may also be loaded onto a computer, other programmable data processing device, or other apparatus, so that a series of operational steps are executed on the computer, other programmable device, or other apparatus to produce a computer-implemented process, so that the instructions executed on the computer or other programmable device provide a process for implementing the functions / actions specified in one or more boxes of the flowchart and / or block diagram.

[0093] Some of the methods described herein are generally designed to be used only by computers and may not be feasible or practical for a human expert to perform completely manually. A human expert who wants to perform a similar task manually (such as inspecting an object) may wish to use a completely different approach, for example, one that leverages expert knowledge and / or the pattern recognition capabilities of the human brain, which would be much more efficient than manually performing the steps of the methods described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0094] Some embodiments of the present disclosure are described herein by way of example only with reference to the accompanying drawings. With specific and detailed reference to the drawings, it should be emphasized that the details shown are by way of example and for purposes of illustrative discussion of the embodiments of the present disclosure. In this regard, the description using the drawings will make apparent to those skilled in the art how the embodiments of the present disclosure may be practiced.

[0095] In the attached figure:

[0096] Figure 1A Elements of an example medication preparation system (PPS) with image-guided syringe type and / or geometry-based process control are shown, according to some embodiments of the present disclosure;

[0097] Figure 1B is a schematic flow chart of an image-guided control method for a syringe manipulation process according to some embodiments of the present disclosure;

[0098] Figures 2A-2C Elements of an example pharmaceutical preparation system (PPS) according to some embodiments of the present disclosure are shown;

[0099] Figure 2D schematically illustrates a syringe assembly according to some embodiments of the present disclosure;

[0100] Figures 2E-2F schematically illustrates an example of a syringe delivery unit according to some embodiments of the present disclosure;

[0101] Figures 2G-2H An example of a holder according to some embodiments of the present disclosure is shown (using a top view);

[0102] Figures 2I-2J An image of a syringe delivery unit according to some embodiments of the present disclosure is shown (in top view);

[0103] Figure 3A shows a detailed block diagram of an example syringe handling subsystem having example interfaces to a holder and to a plunger arm according to some embodiments of the present disclosure;

[0104] Figure 3BSchematically illustrates imaging and image processing elements of a PPS according to some embodiments of the present disclosure;

[0105] Figure 4A A flowchart illustrating an example method for gripping a syringe with a gripper, wherein the gripping is optimized for determined syringe type data, according to some embodiments of the present disclosure;

[0106] Figure 4B A flowchart illustrating an example method of drawing a fluid into a syringe or injecting a fluid from a syringe, wherein the drawing or injecting is selected based on one or more determined syringe characteristics, according to some embodiments of the present disclosure; and

[0107] Figure 4C A flow chart is presented of an example method for determining whether a syringe connector is properly attached to a syringe using one or more determined syringe characteristics according to some embodiments of the present disclosure. DETAILED DESCRIPTION

[0108] The presently disclosed subject matter relates to the field of robotic preparation of medications, and more particularly, but not exclusively, to operations involving the manipulation of fluid transfer units such as syringes.

[0109] Overview

[0110] One aspect of some examples of the present disclosure relates to a pharmaceutical preparation system (PPS) that uses a fluid transfer assembly to transfer fluids (including fluids containing drugs and / or other fluids) between containers to produce a compounded medication suitable for a specific treatment requirement. In some examples, the containers include vials from which fluids are drawn (e.g., vials containing pharmaceutical materials), and intravenous bags (IV bags) in which pharmaceutical materials are mixed before being administered to a patient.

[0111] Given the medical environments in which such systems operate, their acceptance for use carries potentially stringent performance requirements; for example, those for accuracy, speed, and reliability. For example, medications may contain radioactive compounds, so extreme care should be taken to avoid leakage and subsequent contamination of the preparation environment. The pharmaceutical preparations themselves should be reliably prepared, for example, with neither more nor less active ingredient than prescribed to the patient.

[0112] However, there are potentially dynamic and / or uncertain aspects to the operation of such systems and / or their operating environments. For example, there may be a variety of fluid transfer assembly types available for a given system, and / or available fluid transfer assemblies, even of the same type (e.g., same manufacturer and model), may be subject to a degree of manufacturing variability (e.g., batch variability). The drug itself may be provided in formulations with varying properties; specifically, the viscosity of different formulations may vary. Furthermore, human error may be a factor in system configuration.

[0113] In some examples of the present disclosure, during drug preparation, images of a fluid transfer assembly are obtained at one or more stages of its use and subjected to image processing. The results of the image processing are used to determine characteristics of the fluid transfer assembly. Specifically, certain fluid transfer assembly characteristics may be relevant to the selection of values ​​for parameters controlling the manipulation of the fluid transfer assembly.

[0114] Specifically, the geometry of the fluid transfer assembly (e.g., its length and / or diameter) affects how a robotic device that will manipulate it should engage with it. In some instances, these characteristics are optionally determined and / or verified by direct measurements taken from an image of the fluid transfer assembly. This potentially mitigates dangerous situations in which an incorrectly sized and / or configured fluid transfer assembly is inadvertently and / or accidentally placed in a fluid transfer assembly reservoir. Additionally or alternatively, in some instances, fluid transfer assembly characteristics are stored by type (e.g., as fluid transfer assembly type data), and image processing is used to detect identification features of the fluid transfer assembly that are not necessarily directly related to its geometry. These features may include identifiers explicitly provided for the purpose of automatic identification, such as a barcode, QR code, or another imaging pattern. Additionally or alternatively, the identification features may include elements placed on the fluid transfer unit and / or fluid transfer connector for another primary purpose (e.g., a scale mark, a manufacturer's logo) or another purpose. Additionally or alternatively, aspects of the shape of a fluid transfer assembly may identify aspects that are not themselves direct indicators of properties of the fluid transfer assembly that are functionally relevant to the selection of parameter values ​​for manipulation of the fluid transfer assembly.

[0115] Scenarios for using images in fluid transfer assembly manipulation include determining how a fluid transfer assembly carrier should be moved to engage it—for example, where and / or with what diameter to clamp its body and / or fluid transfer connector; and / or where and / or with what manipulator (or portion thereof) to engage its plunger. For example, and even for a group of fluid transfer assemblies that are all of a given type, there may be differences in the relative placement of the fluid transfer unit plungers. In some examples of the present disclosure, a fluid transfer assembly is imaged during the process of fluid transfer assembly engagement to select and / or verify the values ​​of motion and / or positioning parameters that should be used for the fluid transfer assembly carrier and its various actuators.

[0116] Another scenario in which images are used in the manipulation of a fluid transfer assembly is to select how the fluid transfer assembly should be manipulated in order to extract fluid (e.g., from a vial) and / or inject fluid (e.g., into an IV bag). Performing these manipulations quickly may have additional benefits, such as efficient use of the PPS and / or the personnel and / or resources that support its use. However, operating too quickly may result in various types of failure conditions, such as leaks and / or damage due to overpressure of the fluid in the fluid transfer unit. During fluid extraction, applying suction too quickly may result in a sufficiently low vapor pressure to produce undesirable bubbles. In some examples of the present disclosure, fluid transfer assembly characteristics determined based on images are used to help select a target speed for the operation of the fluid transfer unit plunger. In some examples of the present disclosure, the system behavior during the manipulation of the fluid transfer assembly itself is imaged to determine one or more characteristics of the fluid transfer assembly currently being manipulated (e.g., characteristics that are common to the fluid interacting with the fluid transfer assembly). These characteristics can be used to adjust the operating mode of the fluid transfer unit plunger.

[0117] Another scenario where images are used in fluid transfer assembly manipulation is to verify that the fluid transfer unit and / or the fluid transfer assembly of which the fluid transfer unit is a component is correctly configured. For example, the fluid transfer assembly may also include a fluid transfer connector to which the fluid transfer unit is connected. Improper attachment can lead to potential failures, such as fluid leakage. In some instances, geometric features of the fluid transfer unit and / or fluid transfer assembly are imaged and measured to verify that they are in the correct state for use. For example, the relative positioning of assembly components can be measured, such as the protrusion length of a specific portion of a cannula attached to the fluid transfer unit, but the protrusion exceeds the fluid transfer connector, which may not be fully attached. If the fluid transfer connector is not fully attached, the protrusion length may not meet a specific standard, such as a threshold value for its length. In another example of this type of scenario, the fluid transfer unit plunger may not be correctly positioned to allow the full range of movement required to inject / withdraw the target volume of fluid. In some instances, images of the fluid transfer unit are evaluated to ensure that the current positioning of the plunger is consistent with the requirements of the manipulation to be performed.

[0118] Another scenario for using images during fluid transfer assembly manipulation is to verify that the fluid transfer assembly remains within acceptable parameters with respect to any distortion of its shape that may occur during operation. Extreme distortion may indicate a malfunction; however, there may be a normal (even if small) degree of distortion that is acceptable and / or expected. In some examples of the present disclosure, the fluid transfer assembly is imaged during manipulation, and the images are used to assess the level of geometric distortion the fluid transfer assembly is experiencing.

[0119] In the event that a type of actual versus expected failure or mismatch is detected and / or determined to be incipient (e.g., any of the scenarios described above), the PPS optionally responds by any one or more of: adjusting fluid transfer assembly handling, abandoning use of the current fluid transfer assembly, adjusting preparations for incorporating use of another fluid transfer assembly, and / or issuing an alarm. The alarm can be in any suitable form—e.g., audible, visual, local, and / or remote (e.g., an alarm transmitted to a remote station).

[0120] Definition of terms

[0121] The subject matter of the present disclosure relates generally to robotic drug preparation systems, and more specifically, to fluid transfer stations within robotic drug preparation systems. It should be understood that, for the sake of brevity and clarity, the examples described herein (with reference to the accompanying drawings and elsewhere) are described with reference to a subset of components of the drug preparation system; for example, specific aspects of the entire fluid transfer device assembly. In addition, embodiments directly similar to the examples described herein should be understood to be encompassed within the scope of the present disclosure. This includes, for example, specific embodiments and / or combinations of elements and / or subsystems that differ in detail from those explicitly described but are similar in function and / or functional role.

[0122] Medication Preparation System: Embodiments of the robotic medication preparation system and fluid transfer station thereof described herein are configured to perform operations related to transferring medication between different fluid transfer devices.

[0123] The robotic drug preparation system according to the subject matter of the present disclosure (which may alternatively be referred to as a "robotic system") includes elements and / or subsystems, such as a robotic station, a robotic arm, a motor, a control unit and / or other mechanisms that operate to perform, control and / or verify fluid transfer. These elements are optionally designed and / or described as constituting units and / or subsystems and / or consisting of units and / or subsystems that are operable to perform activities associated with the preparation of a drug specified for administration to a patient. For example, a robotic system can include one or more automatic or partially automatic subsystems that include at least one manipulator that is at least partially controlled by a controller unit (equivalently referred to as a controller or control unit). The controller units themselves can be arranged, for example, hierarchically and / or in a network in communication with each other to coordinate the overall operation of the drug preparation system.

[0124] The drug preparation system described herein performs fluid transfer between a container and a fluid transfer unit specified by a fluid transfer device, wherein the latter generally acts as an intermediate element (generally but not necessarily an "active" element, for example, an element that generates pressure and causes fluid movement), and the former is considered to be a fluid source or fluid receiving element (generally but not necessarily a "passive" element). Fluid transfer can be assisted by a fluid transfer connector. However, a common intermediate fluid transfer unit can still optionally operate as an initial source of fluid (for example, in the form of a pre-filled syringe provided at the beginning of drug preparation), and / or operate as a final container of fluid (for example, in the form of a filling unit that is passed on to another process, such as delivery to a patient, storage, or another purpose). The role of a container as both a fluid source and a fluid receiver is not excluded.

[0125] Embodiments of delivery devices can include, for example, one or more catheters, pumps, syringes, bottles, intravenous bags, adapters, and / or needles. Optionally, these components are consumables and / or accessories of a drug preparation system. However, optionally, such components are considered to be drug preparation system components.

[0126] Fluid: As used herein, "fluid" generally includes medication, diluent, saline solution, water, or any other fluid used in medication preparation.

[0127] Fluid Transfer: “Fluid transfer” between a container assembly and a fluid transfer assembly through an opening formed in a port of the container assembly or the fluid transfer assembly and / or through an opening formed in a septum of the container assembly or the fluid transfer assembly.

[0128] Fluid transfer unit: As used herein, a "fluid transfer unit" comprises a fluid receiving device that operates and / or can be operated to draw fluid (e.g., from a first container) and discharge fluid (e.g., into a second container). For example, it can be implemented using a syringe or other fluid container, optionally incorporating appropriate connecting tubing, and can further include components such as a fluid transfer conduit and a body (which holds the fluid contents). To avoid waste of the transferred fluid, a syringe interconnected to another container via a narrow cannula (e.g., a needle or other metal tube having a diameter of, for example, 1 mm or less) has the potential advantage of relatively low dead volume, compared to embodiments in which transfer is performed from a main reservoir of fluid using a relatively wide inner diameter flexible tubing. For example, in the case of a syringe, the body can be understood to include the barrel of the syringe. The fluid transfer unit can include a plunger or other component that moves to cause fluid to move into or out of the body of the fluid transfer unit. The fluid transfer unit itself can constitute a fluid transfer assembly, or it can be coupled to another component, such as a fluid transfer connector, to form a fluid transfer assembly. A fluid transfer unit typically involves the creation of a pressure gradient that causes fluid transfer; that is, its contents and / or its content-receiving compartment experience a pressure change that causes a corresponding change in pressure in a container coupled thereto, and a corresponding fluid transfer.

[0129] Fluid transfer connector: In some examples, the fluid transfer assembly includes a "fluid transfer connector" that is used to establish fluid communication between the fluid transfer unit and the container from which the fluid is transferred / to the container. The fluid transfer connector is optionally associated with the fluid transfer unit itself. Optionally, it is associated with another element that makes a connection, for example, to the container (in which case it may be more specifically referred to as, for example, a "container connector"), and / or is introduced into the fluid transfer process by another part of the robotic system, such as one of its manipulators. The various types of connectors are equivalently referred to as "adapters."

[0130] Fluid Transfer Conduit: In some instances, fluid transfer is described as being performed using a "fluid transfer conduit" to penetrate a container's septum to reach the container. The fluid transfer conduit may comprise a cannula or any other device configured to penetrate a container and transfer fluid therethrough. The fluid transfer conduit may include a bevel at its distal tip (e.g., it may be sharpened to form a needle), an opening on a side surface, or any other configuration. It should be understood herein that, in some instances, fluid transfer may be performed without the fluid transfer conduit penetrating the container's septum, or optionally, without penetrating the septum of a fluid transfer connector (e.g., if it is associated with a fluid transfer assembly). In some instances, fluid transfer is performed via the fluid transfer conduit by controlled pressure of the fluid. If the fluid transfer conduit comprises a needle or needle-like (sharp) tip, the needle may penetrate any number of existing septa. The fluid transfer conduit may penetrate all septa separating the container and the interior of the fluid transfer unit, one septum may be fully penetrated and another partially penetrated, one septum may be partially penetrated and another may not be fully penetrated, or there may be no septum at all.

[0131] Fluid transfer assembly: A "fluid transfer assembly" is described herein, for example, with reference to an assembly comprising a syringe (as a fluid transfer unit) and, optionally, a syringe connector (as a fluid transfer connector). It should be understood that a fluid transfer assembly may include components for delivering medication that function similarly to that of a syringe. For example, a fluid transfer assembly may include a pumping mechanism and a fluid transfer conduit configured to connect to a container for delivering medication. Optionally, the fluid transfer assembly does not include a fluid transfer connector. For example, the fluid transfer connector may form part of a robotic system that operates the fluid transfer assembly. In some instances, a fluid transfer assembly may include a vial or intravenous bag for exchanging fluids with other containers.

[0132] Septum: As used herein, "septum" generally refers to a membrane configured to seal access to a portion of a device to which it belongs. A septum on a container or container connector (also referred to as a container septum) can seal the container. A septum on a fluid transfer assembly (also referred to as a fluid transfer connector septum) can prevent or block access to and / or through a fluid transfer conduit. Typically, a septum is made of a resilient, puncturable material. Such a material can be a polymer with elastic properties, such as rubber.

[0133] Container: When performing fluid transfer, a robotic system operating in accordance with the present disclosure optionally manipulates and / or inspects variously embodied containers. As described herein, a "container" optionally refers to any one or more of the following: a syringe, an IV bag, an elastomeric pump, a vial, a bottle, an ampoule, a syringe, a catheter, a tubing, or generally any vessel or container suitable for holding a fluid or liquid. It should also be understood that a container can be any other element that functions as a component of a fluid transfer device, with or without a connector (or "adapter") for establishing fluid communication between the container and other fluid transfer components. For example, a container can be a vial with a vial adapter, or an IV bag with a spike adapter. Access to the container can be through a container septum, which can be a septum of the container cap or can be part of a connector. During fluid transfer using fluid pressure changes and / or pressure differentials, the container characteristically undergoes fluid transfer due to pressure changes generated within and / or through the fluid transfer assembly to which the container is connected.

[0134] Vial: As used herein, a "vial" (e.g., referring to a container) may include a closable container, such as an ampoule or bottle, formed, for example, of glass or plastic and containing a medication in liquid or powdered form. A vial may be a single-use or multi-use vial. A vial may be tubular or bottle-shaped, having a neck near the vial opening. A vial may be covered with a cap.

[0135] Container assembly: As used herein, a "container assembly" may include: a separate container, or a container with a container connector mounted thereon. The term "vial assembly" is used equivalently, although examples embodying aspects of the present disclosure do not necessarily include a vial in the strict sense (e.g., an ampoule may be present instead). The septum used to at least partially seal the vial access port may be positioned as part of the vial itself and / or as part of the container connector (equivalently referred to as a "vial adapter" or "container adapter"). The container connector may include a device that can be mounted to the vial to facilitate transfer of the vial itself (by grasping the adapter rather than the vial) and / or facilitate transfer of fluid into or out of the vial. The container connector may provide protected (e.g., "closed" and / or maintain sterility) access to the contents of the vial. The container connector may be a sterile device that is disposable or reusable.

[0136] Manipulator: As used herein, a "manipulator" may include structures and / or mechanisms configured to controllably interact with at least one container (e.g., a container loaded onto the system) and / or other components or structures of a drug preparation system. The manipulator may be configured to move at least one container. The manipulator may be configured to cause or facilitate a fluid transfer process; for example, transferring a fluid from one container to another, involving, for example, extracting a fluid and / or inserting (e.g., injecting) a fluid. The manipulator may comprise a robotic arm, a platform, a robotic station, or a combination thereof configured to manipulate a container and / or a fluid transfer assembly. The manipulator may include an actuator, for example, a motor, for facilitating its operation.

[0137] A manipulator is not necessarily embodied as an "arm" per se, even when such terminology is used in connection therewith. For example, several examples are described herein relating to syringes equipped with plungers, wherein the plunger and its piston are manipulated by a plunger arm. It should be understood that the plunger and piston are non-limiting examples of mechanisms that cause a change in fluid pressure when properly manipulated by any suitable means; for example, a screw, weight, spring, wedge, lever, or other pressure generating and / or transmitting device.

[0138] It should also be understood that arrangements that omit and / or do not use an element that protrudes from the piston to allow it to be manipulated (e.g., a plunger shaft) can be used to induce pressure changes in the fluid contents of the fluid transfer unit to cause it to leave or enter the fluid transfer unit. It should be understood that in some instances, arrangements that omit and / or add pistons are optionally provided, while another pressure transmission arrangement of elements is provided; for example, a roller operating on a tube (as in a peristaltic pump), hydrostatic pressure, and / or another operable method to alternately contract or expand the fluid-containing reservoir of the fluid transfer unit, and / or simply apply pressure to the fluid contents in the fluid transfer unit, thereby causing the transfer of the fluid. Such devices are also collectively referred to herein as "fluid pump" devices, which cause the transfer of fluid into or out of the fluid transfer unit (and / or the fluid transfer assembly of which it is a part) based on the pressure applied by the pump. Specifically, in some instances, a syringe whose plunger is engaged with the plunger arm of the pump that moves the plunger provides an element used by the fluid pump.

[0139] Fluid transfer can occur when a fluid transfer assembly is engaged (e.g., clamped) by a manipulator. Engagement (e.g., by a clamp) is optionally used to stabilize the fluid transfer assembly, while any type of pump operates to change the pressure on its fluid contents to transfer it to another container. In some instances, a first manipulator engages a fluid transfer assembly (e.g., a fluid transfer unit and / or a fluid transfer connector) to help stabilize a portion of the fluid transfer assembly, while a second manipulator operates to apply pressure changes to the fluid contents of the fluid transfer unit. In one instance, a manipulator (e.g., a "clamp" or "plunger arm") can include one or more actuators for engaging a syringe and / or pulling or pushing the plunger of a syringe. The manipulator is optionally configured to manipulate other types of fluid containers, such as vials, IV bags, tubes, and / or another suitable container.

[0140] Controller: As used herein, the equivalent terms "controller" and "controller unit" generally refer to circuitry configured to command certain aspects of the behavior of a controlled element, such as the operation of an actuator (which in turn may be an actuator of a manipulator), the operation of a sensor, and / or the operation of an imager. In some instances, the controller comprises computerized circuitry configured to perform operations according to a set of instructions stored on a memory readable by the controller, which may be executed, for example, by a central processing unit (CPU), one or more processors, a processor unit, and / or a microprocessor. Additionally or alternatively, in some instances, the controller utilizes a digital signal processor (DSP), a field programmable gate array (FPGA), a specialized application-specific integrated circuit (ASIC), or other device. Additionally or alternatively, in some instances, the controller or controller unit comprises one or more analog circuits (e.g., based on amplifier feedback) and / or control circuits based on low-level logic gates. In some instances, the control unit may comprise one or more mechanism controllers. The controller unit may comprise any device for controlling an element in a robotic drug preparation system and may comprise at least one of analog control circuitry, a synchronization unit, and a processor.

[0141] Imager: As used herein, the term "imager" refers to any device that operates to produce an image of an object. An example of an imager is an optical camera; for example, a camera equipped with one or more transparent lenses and a light sensor that can be read out to produce a digital image. Optionally, scanning imaging methods are used, for example, imaging the reflectivity of laser illumination scanned from the object back to the sensor. Optionally, interferometric imaging is used, for example, for tracking small deformations and / or movements. Imaging using radiant energy other than visible light is not excluded; for example, acoustic energy, electromagnetic wavelengths outside the visible spectrum, and / or particle (having mass) radiation imaging. Optionally, contact imaging is performed, for example, moving a contact probe along the imaged object to confirm the accuracy of its positioning and or measure one or more contours of its shape.

[0142] Before explaining at least one embodiment of the present disclosure in detail, it should be understood that the present disclosure is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the accompanying drawings and / or presented in the examples. The features described in this disclosure, including the features of the present invention, are capable of other embodiments or of being practiced or carried out in various ways.

[0143] Block diagram of components supporting image-guided fluid delivery unit delivery

[0144] Now refer to Figure 1A , which illustrates elements of an example medication preparation system (PPS) 99 with image-guided process control based on fluid transfer assembly type and / or geometry, according to some examples of the present disclosure.

[0145] In some examples, the fluid transfer assembly manipulation subsystem 220 manipulates the fluid transfer assembly 119 as part of one or more operations of the PPS 99. Supported operations include, for example: using the gripper 130 to grip / release the fluid transfer unit 120 (e.g., at its body 121 and / or connection end 122) and / or the fluid transfer connector 126; using the plunger arm 125 to engage the plunger 137 of the fluid transfer unit 120; drawing fluid from a fluid container 275 (e.g., a vial 115) into the fluid transfer unit 120; and / or injecting fluid from the 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 the bag 116 are not excluded.

[0146] In some examples, the gripper 130 and the plunger arm 125 are components of the fluid transfer assembly carrier 105 (e.g., as described with respect to Figures 2A-2C and / or Figures 2E-2JOptionally, the gripper controller 260 and / or the plunger arm controller 270 are also part of the fluid transfer assembly transporter 105; or they may be in communication with the fluid transfer assembly transporter 105, for example, via a cable, wireless communication, and / or another interconnection.

[0147] The fluid transfer unit connection end 122 can mate with the fluid transfer connector 126 to form the fluid transfer assembly 119, which in turn can be attached to the fluid container 275. The fluid transfer unit 120 includes a fluid transfer unit plunger 137 inserted into the fluid transfer unit body 121 .

[0148] In some examples, the fluid transfer unit manipulation subsystem 220 includes a plunger arm controller 270 operable to control the movement of the mechanical plunger arm 125 (e.g., with respect to Figures 2A-2C and Figures 2E-2F 122 ). When the plunger arm 125 is engaged with the fluid transfer unit plunger 137 (e.g., via the fluid transfer unit body flange 135), controlled movement of the fluid transfer unit plunger 137 withdrawing from the fluid transfer unit body 121 draws fluid from the fluid container 275 into the fluid transfer unit body 121. Conversely, controlled movement of the fluid transfer unit plunger 137 advancing into the fluid transfer unit body 121 injects fluid from the fluid transfer unit body 121 into the fluid container 275. Depending on the configuration of the fluid transfer unit 120, there is a range of available motion of the plunger 137 relative to the fluid transfer unit body 121; i.e., a range limited by the positioning of the piston 123 of the plunger 137 at the limit of its motion near the connection end of the fluid transfer unit body 121 and the positioning of the piston 123 of the plunger 137 maximally withdrawn from the fluid transfer unit connection end 122.

[0149] In some examples, the fluid transfer unit manipulation subsystem 220 includes a gripper controller 260 operable to control movement of the gripper 130 to grip or release the fluid transfer assembly 119, for example, at the fluid transfer unit connection end 122, the fluid transfer unit body 121, and / or the fluid transfer connector 126. Optionally, the gripper controller 260 is operable to place the gripping elements (e.g., jaws 130A, 130B) of the gripper 130 in an appropriate gripping position relative to a gripped location along the fluid transfer assembly 119. Figure 3A A fluid transfer unit manipulation subsystem 220 is depicted.

[0150] The system controller 210 includes processing circuitry 217, which includes a processor 215 and memory 225. The memory 225 stores instructions for the processor 215, as well as data generated when the processor 215 executes the instructions. The memory 225 optionally stores images and / or measurement data generated by the PPS 99 and / or acquired by the processor 215 when executing instructions; for example, images obtained from the imager controller 230 and one or more imagers 240 of the imager subsystem 350.

[0151] The system controller 210 can be operatively connected to the fluid transfer unit manipulation subsystem 220, for example, via a bus or network connection. Optionally, the gripper controller 260 and / or the plunger arm controller 270 are implemented (at least in part) using the circuitry of the system controller 210. Optionally, the gripper controller 260 and / or the plunger arm controller 270 are implemented as separate components.

[0152] The system controller 210 preferably operates at a level that is at least partially abstracted from the hardware manipulation details handled by the gripper controller 260 and / or the plunger arm controller 270. The system controller 210 can be operated, for example, to command the fluid delivery unit manipulation subsystem 220 to move the fluid delivery unit plunger 137 a certain distance to draw a target amount (e.g., volume) of fluid (e.g., a component of a drug to be injected into a patient) into the fluid delivery unit body 121. In response, the plunger arm controller 270 converts the requested distance into an appropriate signal to move the plunger arm 125 accordingly. Optionally, the plunger arm 125 is responsible for detecting and reporting abnormal conditions, such as reaching a limit of motion and / or a discrepancy between the commanded movement and the actual movement produced. Upon receiving such a report, the system controller 210 processes the impact on the overall operation of the device.

[0153] Additionally or alternatively, the system controller 210 may receive abnormality reports and / or indications of abnormal conditions from other sources (e.g., images obtained by the imager controller 230, described below). Accordingly, the system controller 210 may convert these abnormal conditions and / or indications into appropriate additional commands and provide these commands to instruct the fluid delivery unit to operate the subsystem 220.

[0154] In some examples, imager 240 comprises one or more digital imagers configured to image components of PPS 99 and / or operations performed by fluid transfer unit handling system 220. In some examples, imager 240 is positioned in a fixed position relative to fluid transfer assembly 119, e.g., mounted on and moving with fluid transfer assembly carrier 105.

[0155] In some examples, imager 240 can be positioned so that it captures digital images of fluid transfer assembly 119 from a particular (eg, selected) imager distance 295. Movement of imager 240 is optionally performed manually and / or automatically.

[0156] Additionally or alternatively, the imager distance 295 is selected by movement of the fluid transfer assembly 119 when attached to the fluid transfer assembly carrier 105. Additionally or alternatively, the field of view of the imager 240 is selected by operation of the optics of the imager 240 and / or by selecting a particular imager 240 according to its available fixed and / or adjustable field of view characteristics (e.g., with Figures 2I-2J corresponding to one of the fields of view 102A, 102B).

[0157] An imager controller 230 operatively connected to at least one imager 240 implements imager control (e.g., in response to commands from a system controller 210 to which the imager controller is also operatively connected). In addition, it provides digital image acquisition to the system controller 210, e.g., as described with respect to Figure 3B described.

[0158] Flowchart of image-guided fluid delivery unit delivery

[0159] Now refer to Figure 1B , which is a schematic flow chart of an image-guided control method for a fluid transfer unit manipulation process according to some examples of the present disclosure.

[0160] In some examples, at block 50, one or more images of the fluid transfer assembly 119 to be manipulated are acquired (e.g., by processing circuitry 217, e.g., processing circuitry of system controller 210). In some examples, one or more images are acquired using imaging subsystem 350 (e.g., acquired under the control of system controller 210), e.g., as described with respect to Figure 3B described.

[0161] The fluid transfer assembly 119 is optionally a fluid transfer assembly 119 in the fluid transfer assembly reservoir 100 (e.g., as described with respect to Figures 2A-2C and / or Figure 2I ), which is selected for engagement with the fluid transfer assembly transporter 105. Alternatively, this image shows the fluid transfer assembly 119 already engaged with the fluid transfer assembly transporter 105.

[0162] In some examples, at block 52, the image acquired at block 50 is processed to determine one or more characteristics of the fluid transfer unit. Figure 3B Image processing is discussed.

[0163] In some examples, a characteristic of fluid transfer assembly 119 is determined by directly measuring the characteristic itself using the image. For example, an area of ​​the image corresponding to fluid transfer assembly 119 is identified, and the diameter of a portion of the fluid transfer unit is determined based on the size of the fluid transfer unit represented in the image. This can include determining the scale of visible elements in the image, or the scale can be considered fixed, for example, because it always applies to a given set of circumstances.

[0164] In some examples, the characteristics of the fluid transfer unit are static characteristics; for example, geometric properties such as the diameter or length of the fluid transfer unit body, the diameter of the locking area of ​​the connection end, the shape of the connection end of the fluid transfer unit (e.g., the angle of the generally conical taper that characterizes the connection end), or the shape of the fluid transfer unit piston. Such characteristics may be typical of the type of fluid transfer unit and may be useful for type identification, as described below.

[0165] Additionally or alternatively, the characteristics of the fluid transfer unit are dynamic or potentially dynamic. For example, an image can be used to determine deformation of the fluid transfer unit when it is operated—for example, bending and / or torsional deformation of the shaft of the plunger, or expansion deformation of the body of the fluid transfer unit. Such deformation may occur, for example, due to an unexpected blockage of the fluid in response to manipulation. As another example, movement of the fluid transfer unit can be detected as a characteristic of the fluid transfer unit. Such movement can indicate incorrect clamping, and / or incorrect and / or interrupted attachment of a fluid transfer connector to the fluid transfer unit (for example, a fluid transfer connector for adapting the fluid transfer unit to allow fluid communication with a container such as a vial and / or IV bag). In some instances, the movement is movement of an element other than the fluid transfer unit relative to the fluid transfer unit, for example, translation or rotation of the fluid transfer connector.

[0166] Additionally or alternatively, images can be used to monitor the manipulation of the fluid transfer unit. For example, when a command is executed to advance or retract its plunger, the imaged state of the fluid transfer unit can be compared to the expected state. A mismatch can indicate a fault condition and / or indicate a need to adjust and / or recalibrate the manipulation command. In some examples, the contents of the fluid transfer unit are monitored via images, for example, to detect bubble formation (via inlet and / or vapor pressure changes).

[0167] Additionally or alternatively to direct property measurement: In some instances, fluid transfer unit properties are determined by first identifying the type of fluid transfer unit. Type identification is used to determine fluid transfer unit data appropriate for the type. For example, based on the type identification, a data structure defining the properties of the fluid transfer unit can be selected from a plurality of available fluid transfer unit characterization data structures. The type identification itself can be performed using any suitable aspect of the appearance of the fluid transfer unit that is identifiable in the image. The aspect can include a digitally encoded value; for example, a value encoded in a barcode, QR code, or another type of pattern marked on the fluid transfer unit. In some instances, the aspect includes a marking provided for another purpose that is incidentally used for fluid transfer unit type identification. Examples include: a logo (e.g., a manufacturer's trademark), the spacing of scale markings, and / or the characteristic appearance and / or relative positioning of the fonts used in the scale label.

[0168] As described above, in some examples, one or more directly measured characteristics of the fluid transfer assembly 119 (eg, its diameter and / or length) are used as type-identifying aspects of the fluid transfer unit.

[0169] In some examples, fluid delivery unit characteristic identification involves the combined use of data from multiple sensor modalities (eg, including non-image sensing).

[0170] For example, in some instances, an RFID code read from an RFID device attached to a fluid transfer assembly 119 can be used to directly, fully or partially identify its type and / or characteristics. The RFID code can be used to derive fluid transfer unit characteristics (e.g., by selecting a data structure and / or by mapping values ​​directly to characteristics). 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 information of the RFID tag is consistent with the actual visible fluid transfer unit. Thereafter, imaging is optionally used to monitor the manipulation of the fluid transfer unit, e.g., to verify the performance of the fluid transfer assembly 119 when manipulated based on its characteristics.

[0171] In some examples, at block 54 , the fluid transfer unit is manipulated according to a value of an operating parameter, which in turn is determined according to one or more fluid transfer unit characteristics determined at block 52 .

[0172] Examples of operating parameters include those that control the positioning of elements of the fluid transfer assembly carrier 105 that engage with the fluid transfer assembly 119; for example: an appropriate clamping diameter for use with the clamp 130, an appropriate size of the plunger flange 136 to be engaged by the plunger arm 125, and / or appropriate positioning of any of the clamp 130, the plunger arm 125, and / or the fluid transfer assembly carrier 105 so that the fluid transfer assembly 119 is in the correct relative positioning to be engaged.

[0173] In addition to directing the engagement of fluid transfer assembly 119 with fluid transfer assembly transporter 105, values ​​of operating parameters may also be selected to appropriately manipulate fluid transfer assembly 119. For example, there may be potential benefits to performing manipulation of fluid transfer assembly 119 as quickly as possible and consistent with constraints. Constraints may include, for example, target and / or maximum internal fluid transfer unit pressures, appropriate safety margins for the fluid transfer unit and / or contents, viscosity of the contents, actuator capabilities, susceptibility of the contents to rough handling, flow resistance associated with the fluid transfer unit, and / or strength of the container into and / or from which the fluid is being transferred.

[0174] In some examples, one or more characteristics of the fluid transfer unit may be used as an indirect indication of a manipulated parameter value, e.g., a target maximum pressure for 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 for a parameter, such as the forward speed of the fluid transfer unit plunger 137 as a target for actuation of the plunger arm 125. Additionally or alternatively, one or more characteristics of the fluid transfer unit are directly specified as parameter values; e.g., as a maximum plunger speed.

[0175] In addition, and however the operational parameter values ​​are first selected: in some instances, verification of the manipulation of the fluid transfer assembly 119 is performed using images obtained during the fluid transfer unit manipulation process. For example, images can be obtained showing that the actual change in positioning of the fluid transfer unit plunger 137 is consistent with the commanded change and / or consistent with monitoring measurements taken using another sensor type (such as an actuator encoder, a pressure sensor, a limit sensor, or another sensor). In some instances, images and image processing are used to ensure that the fluid transfer unit 120 and / or an element to which the fluid transfer unit 120 is connected (such as the fluid transfer connector 126) maintains a stable configuration when manipulation is applied to the fluid transfer assembly 119. In some instances, images and image processing are used to verify that the contents of the fluid transfer unit are contained as expected (e.g., there is no leakage characterized by dripping, spraying, and / or a mismatch between expected and actual positioning). Optionally, radiographic imaging is used to verify that there is no radioactive leakage. In some examples, images and image processing are used to verify that the contents of the fluid transfer unit are not subject to bubble formation, such as due to vaporization due to a decrease in pressure during withdrawal of the fluid transfer unit plunger 137 .

[0176] Optionally, when the validation results indicate a discrepancy with expectations, the operation of the PPS 99 is suspended and / or an alarm is generated. Optionally, the validation results are used to adjust the values ​​of operating parameters to bring actual operations into compliance with a target metric, such as the speed of drug preparation, for example, when expected performance is subject to normal variation and / or is not predetermined.

[0177] Drug preparation system

[0178] Now refer to Figures 2A-2C , which illustrates elements of an example medication preparation system (PPS) 99 according to some examples of the present disclosure.

[0179] Figure 2A and 2B Different examples of PPS 99 are shown in overview. Figure 2C Shown Figure 2B Examples of some elements are partially suppressed (dimmed) in order to emphasize elements that are particularly relevant to the description herein.

[0180] In some examples, PPS 99 includes a vial holding unit 110 that holds fluid vials 115. Fluid vials 115, in turn, contain fluid to be drawn into and / or received from a fluid transfer unit 120 during a robotic preparation process of, for example, medication for injection and / or infusion.

[0181] The illustrated example of a PPS 99 includes a fluid transfer assembly reservoir 100 that includes fluid transfer units that can be used with the PPS. Figure 2AIn the example of , the fluid transfer assembly reservoir 100 is implemented as a linear array of fluid transfer units. Figure 2B In the example of FIG. 1 , the fluid transfer assembly reservoir 100 is implemented as a fluid transfer assembly carousel.

[0182] In some instances, one or more digital imagers are used to provide imaging capabilities. Figure 2B ), an imager tower 101 is positioned so that one or more imagers thereof can be used to view the fluid transfer assembly transporter 105 and / or the fluid transfer units of the fluid transfer assembly reservoir 100. Optionally, one or more imagers are placed in another location; for example, integral to one or both of the elements of the fluid transfer assembly transporter 105 and the fluid transfer assembly reservoir 100 (e.g., within the housing of the fluid transfer assembly carousel). Optionally, an imager of another element of the PPS 99 is provided for viewing at least some operations of the fluid transfer assembly transporter 105; for example, an imager placed on the rack viewing arm 102, an imager placed on the vial viewing unit 103, or an imager placed elsewhere. Optionally, images can be provided by one or more imager sources external to the PPS 99 itself (e.g., a roving monitor device that can be controlled manually or automatically) to obtain images from dynamically selected viewpoints, for example, to supplement the imaging capabilities on the device when the image input is otherwise determined to be insufficient (e.g., ambiguous and / or requiring more detailed diagnostic attention).

[0183] The illustrated example of the PPS 99 includes a fluid transfer assembly transporter 105 that transports fluid transfer units. In some examples, the fluid transfer assembly transporter 105 can be moved to remove a fluid transfer assembly 119 from the fluid transfer assembly reservoir 100 and then moved between different positions (e.g., along an axis of motion 105A, such as Figure 2B ) to prepare for injection according to a specific preparation sequence. In some examples, there may be movement along another axis that properly aligns transfer assembly transporter 105 with transfer assembly reservoir 100 and / or with a fluid container with which fluid transfer assembly 119 is to exchange fluid contents. Movement should be understood as relative movement; for example, it may optionally involve movement of transfer assembly transporter 105 itself and / or movement of another component of PPS 99 (e.g., a lift platform).

[0184] Furthermore, operating in its capacity as a pump and / or as an operational portion thereof, fluid transfer assembly transporter 105 manipulates the fluid transfer assembly 119 it carries to extract liquid (e.g., from vial 115) into fluid transfer unit 120 and / or to inject liquid from fluid transfer unit 120, for example, into a medication container such as bag 116 (e.g., an intravenous bag, also referred to herein as an IV bag), which has been positioned in transfer rack 117 ( Figure 2B )superior.

[0185] In some examples, the fluid transfer assembly transporter 105 includes a gripper 130 that engages the fluid transfer assembly 119 to hold it during the compounding process. More specifically, the gripper 130 optionally engages the fluid transfer unit body 121, the fluid transfer unit connection end 122, and / or the fluid transfer connector 126 of the fluid transfer assembly 119. Furthermore, the fluid transfer assembly transporter 105 includes a plunger arm 125 that is operable to grasp a plunger 137 of the fluid transfer unit 120, for example, at a plunger flange 136 and / or along the axis of the fluid transfer unit plunger 137.

[0186] During the reassembly process: Once the plunger arm 125 is engaged with the fluid transfer unit plunger 137, and when the body 121 of the fluid transfer unit 120 is restrained (e.g., by the holder 130), movement of the plunger arm 125 in the direction of the fluid transfer unit connection end 122 pushes the piston 123 of the fluid transfer unit plunger 137 further into the fluid transfer unit body 121. Movement of the plunger arm 125 in the opposite (proximal) direction pulls the piston 123 of the fluid transfer unit plunger 137 toward the base of the fluid transfer unit body 121, i.e., toward the fluid transfer unit body flange 135.

[0187] Fluid transfer unit assembly and fluid transfer unit transporter

[0188] Now refer to Figure 2D , which schematically illustrates a fluid transfer assembly 119 according to some examples of the present disclosure. Figures 2E-2F , which schematically illustrates an example of a fluid transfer assembly carrier 105 according to some examples of the present disclosure.

[0189] More specifically, Figure 2D Features of the fluid transfer assembly 119 are shown, and Figures 2E-2F A front view of the fluid transfer assembly 119 held by the fluid transfer assembly carrier 105 is shown ( Figure 2E ) and isometric perspective ( Figure 2F ).exist Figure 2EIn the front view of FIG, the piston 123 of the fluid transfer unit plunger 137 is seen entering the body 121 outside the cross-sectional view 121A (the cross-sectional view 121A is for illustration purposes only and is not a structural element of the body 121).

[0190] Figure 2D A fluid transfer assembly 119 is shown that includes, in addition to a fluid transfer unit 120, a fluid transfer connector 126 (distally engaged with the fluid transfer unit connection end 122, e.g., via a Luer taper connector) and a connector septum 131 (distally engaged with the fluid transfer connector 126).

[0191] In some examples, the fluid transfer connector 126 is a device that securely attaches the fluid transfer assembly 119 to, for example, a vial or intravenous (IV) bag. For example, it can include features that prevent and / or mitigate the risk of accidental disconnection and / or partial connection, and / or features that prevent and / or help control pressure differentials generated during injection and / or withdrawal of fluid from and / or into the fluid transfer unit 120.

[0192] In some examples, connector septum 131 comprises a surface for maintaining isolation from contamination, and a cannula (eg, a needle) pierces the surface to allow aspiration and / or injection of fluid.

[0193] Optionally (e.g., as Figures 2E-2F ), the plunger arm 125 includes one or more recesses 125A, 125B that are sized differently to accommodate differently sized portions of the fluid transfer unit plunger 137, such as differently sized plunger flanges 136. During operation of engaging the fluid transfer assembly 119, the fluid transfer unit manipulation subsystem 220 optionally selects which of the recesses 125A, 125B to engage based on a detected fluid transfer unit geometry and / or type, such as that detected by digital image processing. The selection can be made by moving the plunger arm 125 along the movement axis 125C to the appropriate position ( Figure 2E ).

[0194] Gripper operation

[0195] Now refer to Figures 2G-2H, which illustrates (using a top view) an example of a holder 130 according to some examples of the present disclosure. In some examples, the holder 130 includes two jaws 130A, 130B that separate to form an inlet of appropriate size to accept a range of diameters of the fluid transfer unit body 121, the fluid transfer unit connection end 122, and / or the fluid transfer connector 126. For example, the acceptable range of diameters can include diameters of 5-10 mm, 6-8 mm, 5-25 mm, or other ranges. The range can include larger values ​​(e.g., up to 20-30 mm), especially for holders 130 that are attached along the body 121. For holders 130 designed to attach to the fluid transfer unit connection end 122, for example, to receive and lock onto a portion of the fluid transfer connector 126 and / or a protruding cylindrical portion of the fluid transfer connector 126 itself, the range can be limited to relatively narrow diameters (e.g., diameters <10 mm).

[0196] In some examples, the jaws 130A, 130B themselves are configured to accommodate a range of diameters (i.e., more than one diameter). For example, the jaws 130A, 130B can include a flexible lining that can be adjusted (e.g., compressed) to conform to the various diameters of the gripped portion of the fluid transfer unit. In some examples, each of the jaws 130A, 130B includes a plurality of resilient interconnections (e.g., spring interconnections) that are spaced apart to accommodate the gripped portion of the fluid transfer assembly 119.

[0197] The clamp 130 is optionally actively and / or passively adjusted to accommodate different diameters. In some instances, the clamp 130 is configured to ensure contact at at least three or more (at least sometimes discrete) locations distributed around the circumference, rather than ensuring continuous contact of the fluid transfer unit over its entire circumference. For example, the clamp 130 may include at least three separate jaws. In some instances, the jaws 130A, 130B may extend to a variable extent from the housing 105B of the fluid transfer assembly transporter 105. They may use the housing 105B itself and / or an extension of the housing 105B as a "third jaw" such that the fluid transfer assembly 119 is clamped laterally between the jaws 130A, 130B, and between one or both of the jaws 130A, 130B and the housing 105B and / or an extension of the housing 105B. The extension of the housing 105B itself may be actively actuated, or it may be a static element against which the jaws 130A, 130B compress the fluid transfer assembly 119 .

[0198] The positioning of the jaws 130A, 130B relative to the fluid transfer assembly 119 is optionally controlled by any one or more of: adjusting the position of the jaws 130A, 130B along the distal / proximal axis of the fluid transfer assembly 119; adjusting the depth of the fluid transfer assembly 119 within the gripping area defined by the holder 130 (e.g., defined by the jaws 130A, 130B); and / or adjusting the lateral centering of the fluid transfer assembly 119 within the holder 130 (e.g., within the jaws 130A, 130B). The actuators that adjust the positioning may act on, for example: the fluid transfer assembly 119 (e.g., by advancing or otherwise moving the fluid transfer assembly reservoir 100 itself); the jaws 130A, 130B (and / or another element of the holder 130 itself); and / or the entire fluid transfer assembly carrier 105. The selection of the target location is optionally based on the location learned from the actuator encoder measurements. In some examples, image processing (of the fluid transfer unit and / or fluid transfer assembly carrier 105) is used to confirm the actuator encoder measurements, for example, to ensure that the fluid transfer assembly 119 is properly installed in its holder, so that the actuator encoder measurements can be relied upon. Optionally, image processing is used as the primary source of input data that guides the movement of the assembly fluid transfer unit manipulation subsystem.

[0199] In some instances, more than one clamping device (e.g., more than one pair of jaws 130A, 130B) is provided for use with the clamp 130, and the fluid transfer assembly transporter 105 is operated to select an appropriately sized clamping element based on the type, geometry, and / or clamping location of the fluid transfer assembly 119.

[0200] In some examples, one or more gripping devices of the gripper 130 are implemented in other ways rather than as a pair of jaws. For example, the gripper 130 can be implemented as a noose that slides over the distal or proximal end of the fluid transfer assembly 119 (optionally, the distal or proximal end of the fluid transfer unit 120 assembled with the fluid transfer connector 126). Once generally in place, the noose can be tightened to secure the fluid transfer assembly 119 in place.

[0201] In some examples, the gripping device of the gripper 130 is implemented as a single "jaw" that moves from a receptacle position that allows entry of the fluid transfer unit to a gripping position that closes the entry. For example, such a single jaw can extend from the fluid transfer assembly transporter 105 along a first side of the fluid transfer assembly 119, bend around the fluid transfer assembly 119 (e.g., bend as it extends), and then reengage the fluid transfer assembly transporter 105 on a second side of the fluid transfer unit. At this stage, the gripping device can be locked in place (e.g., locked to 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 it is engaged with.

[0202] Fluid Transfer Unit Transporter Imaging

[0203] Now refer to Figures 2I-2J , which shows (in top view) an image of a fluid transfer assembly carrier 105 according to some examples of the present disclosure. For clarity of illustration, Figures 2I-2J Elements of PPS 99 other than imager tower 101, carousel-implemented fluid transfer assembly reservoir 100, and fluid transfer assembly transporter 105 itself are suppressed in FIG, but should be understood to be applicable to various general embodiments of PPS 99.

[0204] For example, as regards Figure 2B As described, the imager can be placed in any one or more of several positions to view the fluid transfer assembly transporter 105. In the example shown, the imager tower 101 includes one or more imagers 240 that are oriented and operable to allow the fluid transfer assembly transporter 105 to be imaged at any position along its axis 105A. Optionally, the imager tower 101 provides, for example, a first field of view 102A ( Figure 2I ) and the second field of view 102B ( Figure 2J ), the first field of view being suitable for imaging the fluid transfer assembly transporter 105 when the first field of view is engaged with the fluid transfer assembly reservoir 100. The field of view change can be performed, for example, by operating zoom optics and / or by switching between multiple imagers. In some examples, the resolution of the imager 240 is sufficiently high that sufficient imaging resolution is achieved at all available positions of the fluid transfer assembly transporter 105, optionally without adjusting the field of view. Image processing is optionally limited to an imager image region selected based on a known position of the fluid transfer assembly transporter 105 relative to the appropriately positioned imager 240, for example, based on known actuator encoder measurements and / or based on a relative position known from a previous stage of image processing.

[0205] In some examples, illumination is provided using illuminators 106 located on the fluid transfer assembly transporter 105 itself. Additionally or alternatively, illumination is provided from one or more illuminators located elsewhere on the PPS 99 and / or by illuminators of the operating environment of the PPS 99.

[0206] Fluid Transfer Unit Manipulator Subsystem—Gripper Control

[0207] Now refer to Figure 3A , which shows a detailed block diagram of an example fluid transfer unit manipulation subsystem 220 having example interfaces to the gripper 130 and to the plunger arm 125 according to some examples of the present disclosure.

[0208] The holder 130 may be a physical device for holding a portion of the fluid transfer assembly 119, such as the fluid transfer unit body 121, the fluid transfer unit connection end 122, and / or the fluid transfer connector 126; for example, as described with respect to Figure 2A –2C and / or Figure 2E –2H described. In some examples, the retraction and release of the gripper 130 is controlled by the gripper controller 260 (including both actuator and control functions in the example shown). The physical movement that causes the movement of the gripper 130 is implemented by the gripper actuator 320. In one example of how the gripper actuator 320 can be implemented, the gripper actuator 320 can include registers 320A, which in turn can provide a logical control interface to the gripper control unit 335. Additionally or alternatively, the gripper control unit 335 provides control signals directly to the gripper actuator 320. Additionally or alternatively, the processing circuit system 217 (e.g., the processing circuit system 217 of the system controller 210) directly commands the gripper actuator 320.

[0209] The following examples are described from the perspective of a register-based implementation. It should be understood that other implementations are equally applicable, allowing, for example, analog control lines, signaling via a non-register protocol (such as a serial interface command protocol), or control of the mentioned functions via another method.

[0210] In some examples, register 320A comprises a control register that, when written to by grip control unit 335, causes gripper 130 to grip an appropriately sized object positioned within the gripping vicinity 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 grip control unit 335 to initiate gripping of an object.

[0211] In some examples, register 320A comprises a control register that, when written to by grip control unit 335, causes gripper 130 to open (i.e., release any suitably sized object located within the gripping vicinity of gripper 130). In some examples, gripper controller 260 provides some other suitable mechanism to enable processing circuitry 217 and / or grip control unit 335 to initiate release of a gripped object.

[0212] In some examples, register 320A includes a control register that receives data indicating a target clamping force (e.g., in units convertible to Newtons) to be used by the gripper 130 when gripping. The processing circuit system 217 and / or the gripping control unit 335 can then write data indicating the clamping force to be used when gripping. It should be understood that the gripping force can be indicated in other ways; for example, using an analog indication that is considered proportional to the target gripping strength and / or a voltage that is used to drive the gripper 130.

[0213] In some examples, register 320A includes a control register that receives data indicating the distance (e.g., diameter) between the gripping jaws of gripper 130 (e.g., in millimeters) for gripper 130 to aim at when gripping. Processing circuit system 217 and / or gripping control unit 335 can then write data indicating the gripping diameter to be utilized when gripping. It should be understood that gripping force can be indicated in other ways; for example, using a voltage that is an analog indication that is proportional to the target size of the object being gripped.

[0214] Additionally or alternatively, the gripper controller 260 provides another suitable mechanism to enable the processing circuitry 217 and / or the gripping control unit 335 to specify a gripping force and / or a target jaw distance during gripping.

[0215] In some examples, register 320A includes a control register that, when written to by processing circuitry 217 and / or gripping control unit 335, causes the gripper 130 to move a specified distance (e.g., upwards of 5 millimeters) in a specified direction along the fluid transfer assembly 119. In this way, processing circuitry 217 and / or gripping control unit 335 can control the position along the fluid transfer assembly 119 at which the gripper 130 will grip. Additionally or alternatively, register 320A provides a control register that, when written to by processing circuitry 217 and / or gripping control unit 335, causes the gripper 130 to move in a specified direction until stopped, for example, by a subsequent write to a different control register.

[0216] Additionally or alternatively, the gripper controller 260 provides some other mechanism to enable the processing circuitry 217 and / or the gripper control unit 335 to control the positioning of the gripper 130 along the fluid transfer assembly 119 .

[0217] In some examples, register 320A includes a read register that provides data indicating a measure of friction between the gripper 130 and the gripped object. The processing circuitry 217 and / or the gripping control unit 335 can then read from this register to determine the current measure of friction (e.g., units convertible to a coefficient of friction).

[0218] Additionally or alternatively, the gripper controller 260 optionally provides some other suitable mechanism to enable the processing circuitry 217 (eg, the gripping control unit 335 ) to obtain a measure of friction between the gripper 130 and the gripped object.

[0219] In some embodiments, elements of the PPS 99 itself are used to measure a measure of friction. For example, the grip of the gripper 130 is gradually loosened until a known force (e.g., a force applied to the body 121 or another portion of the gripped fluid transfer assembly 119) is sufficient to cause the fluid transfer assembly 119 to slip a detectable amount. One or more images of the fluid transfer assembly 119 can be obtained to determine whether slippage has occurred. Knowing the restraining force of the gripper 130 and the force applied during slippage allows calculation of a coefficient that is and / or indicates a measure of friction.

[0220] Fluid Transfer Unit Manipulator Subsystem—Plunger Arm Control

[0221] The plunger arm 125 may be a physical means for moving the plunger 137 into and / or out of the fluid transfer unit body; for example, as described with respect to Figures 2A-2C and / or Figures 2E-2G The movement of the plunger arm 125 can be controlled by the plunger arm controller 270, for example, as described with respect to Figure 1A Optionally, the plunger arm controller 270 includes registers 320B, which in turn can provide a logic interface from the plunger arm control unit 345 and / or directly from the processing circuitry 217 to the plunger arm actuator 321 .

[0222] The following examples are described from the perspective of a register-based implementation. It should be understood that other implementations are equally applicable, allowing, for example, analog control lines, signaling via a non-register protocol (such as a serial interface command protocol), or control of the mentioned functions via another method.

[0223] In some examples, registers 320B provide one or more control registers that, when written to by the processing circuitry 217 and / or the plunger arm control unit 345, cause the plunger arm 125 to move the fluid transfer unit plunger 137 a specific distance in a specific direction at a specific target speed. In some examples, registers 320B include registers containing data indicating the distance, direction, and target speed of movement of the fluid transfer unit plunger 137. The processing circuitry 217 and / or the plunger arm control unit 345 write to these registers to specify the distance, direction, and target speed of movement of the fluid transfer unit plunger 137. In some examples, the plunger arm controller 270 provides a different (e.g., non-register-based) mechanism to enable the plunger arm control unit 345 to control the movement of the fluid transfer unit plunger 137.

[0224] Optionally, the register 320B includes a read register that provides data indicative of the actual average speed of completed fluid transfer unit movements. For example, the register may contain the actual speed of the most recent fluid transfer unit movement, or the actual movement time of the most recent fluid transfer unit movement (which, together with the movement distance, indicates the average movement speed). In some instances, the plunger arm controller 270 provides some other (e.g., non-register-based) suitable mechanism to enable the plunger arm control unit 345 to monitor the movement of the fluid transfer unit plunger 137 and / or determine the actual average speed of completed fluid transfer unit movements. Optionally, the actual speed reading is verified or provided by image-based processing, for example, as described with respect to Figure 4B described.

[0225] In some examples, portions of fluid transfer unit manipulation subsystem 220 are implemented by processing circuitry 217 , which in turn may include processor 215 and memory 225 .

[0226] The processor 215 may include any suitable hardware-based electronic device with data processing capabilities, such as a general-purpose processor, a digital signal processor (DSP), a field programmable gate array (FPGA), a specialized application-specific integrated circuit (ASIC), one or more cores in a multi-core processor, or other devices. The processor 215 optionally includes any suitable number of processors, ASICs, virtual processors, FPGAs, and combinations thereof.

[0227] The memory 225 includes, for example, any suitable type of volatile and / or non-volatile storage. It may include one or more physical memory components. The memory 225 may be configured to, for example, store instructions for computing, as well as data used in computing and / or generated during computing.

[0228] The processing circuit system 217 can be configured to execute any suitable number of functional modules according to computer-readable instructions implemented on a non-transitory computer-readable storage medium. Such functional modules should be understood to be contained in the processing circuit system 217. The functional modules can include, for example, the clamping control unit 335, the plunger arm control unit 345, and other units suitable for generating movement purposes, as well as functional modules for other purposes, for example, as described with respect to any of the figures herein.

[0229] In some examples, the clamp control unit 335 implements logic for controlling the clamp 130 to clamp and release the fluid transfer assembly 119 during a drug compounding operation, for example, by clamping the fluid transfer unit body 121, the fluid transfer unit connection end 122, and / or the fluid transfer connector 126. The clamp control unit 335 can induce the clamp actuator 320 to perform clamping / release, for example, in response to a command from the system controller 210, of which the processing circuit system 217 can be a part. In some examples, the clamp control unit 335 performs clamping / release by writing to the register 320A. Again, a register-based control mechanism should be understood as an optional and non-limiting example; other optional control methods include, for example, serial communication and / or analog signaling.

[0230] In some examples, gripping control unit 335 performs gripping of gripper 130 based on identification information that identifies fluid transfer assembly 119 by type, such as determined from an image obtained by imager controller 230 and captured and processed by system controller 210. Additionally or alternatively, relevant characteristics of fluid transfer assembly 119 are identified based on measurements of the geometry of fluid transfer assembly 119, such as measurements of the size of the fluid transfer unit based on image processing.

[0231] As a non-limiting example: Optionally, the clamping control unit 335 can control the clamp 130 during the clamping process to constrain the clamping jaws to a specific diameter appropriate for the diameter of a particular fluid transfer assembly 119 at a certain location along its axial length (e.g., along the fluid transfer unit body 121, at the fluid transfer unit connection end 122, and or on the fluid transfer connector 126). In some examples, the clamping control unit 335 determines the appropriate clamping diameter using a data table that associates fluid transfer unit types and / or fluid transfer unit geometries with appropriate clamping diameter values. Additionally or alternatively, the clamping control unit 335 selects the appropriate clamping diameter through another mechanism; for example, a machine learning classification of the fluid transfer unit type, which may not explicitly rely on specific aspects of how the fluid transfer assembly 119 appears in the image. In some examples, for example, image examples depicting a variety of fluid delivery unit types are presented during the learning phase of a machine learning classifier's generation, where each fluid delivery unit type is depicted under various suitable conditions, for example, at different scales and / or orientations, in different image environments (backgrounds), and / or with different image qualities (e.g., lighting quality, image resolution, depth of field, and / or image focus quality). Using machine learning training techniques, for example, to enhance correct classification through modification of node association weights, the classifier's ability to distinguish fluid delivery units by type may not necessarily rely on a single clearly identifiable visual characteristic of the fluid delivery unit.

[0232] As another non-limiting example: if the clamp 130 clamps the fluid transfer assembly 119 at a point relatively closer to the connection end of the fluid transfer unit, the lever torque at the plunger 137 will be correspondingly relatively larger, so that for example, if the plunger 137 bends, it will be relatively easier to twist the fluid transfer assembly 119 out of position when a misalignment force is applied.

[0233] In some instances, the clamping control unit 335 utilizes a clamping position on the fluid transfer unit body 121 that is appropriate for, for example, the width, wall thickness, and / or manufacturer of the particular fluid transfer unit being utilized. For example, it may be preferable to clamp a fluid transfer assembly 119 having a relatively more fragile plunger 137 at a position relatively closer to the proximal (bottom) flange 135 of the fluid transfer unit 120 to reduce the risk of loss of good alignment engagement between the fluid transfer assembly carrier 105 and the fluid transfer assembly 119. In some instances, the clamping control unit 335 determines the clamping height based on a table that associates fluid transfer unit types with appropriate clamping height values. Additionally or alternatively, the clamping control unit 335 determines the clamping height by another mechanism, such as machine learning classification.

[0234] The plunger arm control unit 345 can control the plunger arm 125 to insert or withdraw the plunger 137 from the fluid transfer unit body 121 during a medication compounding operation (thereby injecting fluid from the fluid transfer unit body 121 into the fluid container 175, or aspirating fluid from the fluid container 175 into the fluid transfer unit body 121). The plunger arm control unit 345 can perform the insertion or withdrawal; for example, in response to a command from the system controller 210. In some examples, the plunger arm control unit 345 controls the insertion / withdrawal by writing to the register 320B.

[0235] In some examples, the plunger arm control unit 345 controls the insertion / retraction of the plunger arm 125 using a movement distance / direction and / or a target speed that is consistent with a determined fluid transfer unit characteristic, such as, for example, a fluid transfer unit characteristic that can be determined using an image obtained by the imager controller 230 and retrieved by the system controller 210. In some examples, the plunger arm control unit 345 controls the insertion / retraction of the plunger arm 125 at a target speed that is selected based on one or more determined characteristics of the fluid transfer assembly 119 (e.g., its flow resistance) and a value obtained for the viscosity of the fluid being drawn or injected. The fluid viscosity value can be expressed, for example, in centipoise and can be used by the system controller 210 to calculate the target speed and / or provided for controlling the plunger arm control unit 345. In some examples, the value of the relevant parameter indicative of the viscosity of the fluid is empirically determined by PPS 99, for example, by a series of operations of pumping / discharging fluid into / from fluid transfer unit 120 while measuring the forces and / or movement speeds generated during the operations.

[0236] As a non-limiting example, if the target speed utilized during movement is too low, injection or extraction will take longer than necessary, thereby reducing the throughput of the PPS 99. Conversely, if the target speed utilized during movement is too high, fluid insertion or extraction may fail, leaks may occur, bubbles may form due to excessively low vapor pressure, and / or damage may occur to the fluid transfer unit components. Therefore, in some examples, the plunger arm control unit 345 sets the target speed parameter for the plunger 137 to a value (e.g., in mm / s) appropriate for the particular fluid transfer assembly 119 being used. For example, this may be appropriate based on the fluid transfer unit 120 width (diameter), the fluid transfer unit 120 length, the plunger 137 configuration, the wall thickness of the fluid transfer unit body 121, the manufacturer of the fluid transfer unit 120, the rated peak operating pressure of the fluid transfer unit 120, or other characteristics. In some examples, the plunger arm control unit 345 sets the target speed to a value (e.g., in mm / s) appropriate for the contents of the fluid transfer unit (e.g., the viscosity of the fluid). Optionally, a rate value lower than the otherwise allowed maximum may be used, for example where drug preparation time is limited by factors other than fluid delivery rate and / or the latency requirements for use of PPS 99 are sufficiently low.

[0237] In some examples, the plunger arm control unit 345 determines the target speed based on a table that associates fluid transfer unit properties with appropriate target speed values. Optionally, this includes properties of the filled fluid transfer unit that are affected by its contents, such as the viscosity of the contents. Additionally or alternatively, the plunger arm control unit 345 determines the target speed through another mechanism, such as machine learning classification and / or empirical testing.

[0238] In some such examples, the plunger arm control unit 345 dynamically adjusts the target plunger movement to reduce or increase the target speed. In some examples, this adjustment is performed using information indicating the actual average speed of the plunger movement, which is read from measurements made using actuator sensors and / or registers (e.g., register 320B) and / or as determined by image processing of images obtained via the imager controller 230 and acquired by the system controller 210. In some examples, the determination of the actual speed based on image processing is used to verify speed measurements made using other sensors, for example to ensure that the movement is not associated with performance issues such as leakage, damage, and / or loss of proper engagement of the fluid transfer unit.

[0239] Imager subsystem

[0240] Now refer to Figure 3B , which schematically illustrates imaging and image processing elements of the PPS 99 according to some examples of the present disclosure.

[0241] In some examples, imager subsystem 350 includes imager 240 and imager controller 230. The functions of imager controller 230 include interfacing with imager 240 to control image acquisition according to high-level instructions from processing circuitry 217, and receiving captured images from imager 240 to be acquired by processing circuitry 217.

[0242] Other functions related to image processing are optionally performed in whole or in part by imager controller 230; for example, features of fluid transfer unit identification unit 365 and / or fluid transfer unit geometry measurement unit 375, etc., as described next with respect to processing circuitry 217. However, for ease of description, processing circuitry 217 and imager controller 230 are described as functionally distinct units.

[0243] In some examples, the imager controller 230 is in functional communication with the processing circuitry 217. Embodiments of the processor 215 of the processing circuitry 217 optionally include any suitable hardware-based electronic device having data processing capabilities; for example, a general-purpose processor, a digital signal processor (DSP), a field-programmable gate array (FPGA), a specialized application-specific integrated circuit (ASIC), one or more cores in a multi-core processor, etc. The processor 215B may also include, for example, multiple general-purpose processors, ASICs, virtual processors, and / or combinations thereof.

[0244] In some examples, memory 225 includes, for example, suitable types of volatile and / or nonvolatile storage; for example, one or more physical memory components. Memory 225 stores instructions for processor 215 and data generated when processor 215 executes the instructions.

[0245] The processing circuit system 217 is configured to execute one or more functional modules related to image acquisition and / or processing according to computer-readable instructions implemented on a non-transitory computer-readable storage medium, such as stored by the memory 225. Such functional modules are hereinafter referred to as being implemented by the processing circuit system 217 (which itself may be part of the system controller 210 and / or provided separately). Examples of these functional modules include the imager interface unit 355, the fluid transfer unit identification unit 365, and the fluid transfer unit geometry measurement unit 375.

[0246] The imager interface unit 355 communicates with the imager controller 230 to control the imager 240, in particular, to acquire digital images of components including the PPS 99 and / or the fluid transfer assembly 119, such as the fluid transfer connector 126, the fluid transfer unit plunger 137, the fluid transfer unit body 121, the fluid transfer unit piston 123, the fluid transfer unit connection end 122, the gripper 130, and / or the plunger arm 125. The operation of the interface unit 355 can, in turn, be controlled, for example, by commands from other functional units of the system controller 210.

[0247] In some examples, the fluid transfer unit identification unit 365 determines fluid transfer unit characteristics based on the type of fluid transfer unit identified by image processing of the digital image provided by the 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 the fluid transfer unit plunger is partially withdrawn from the fluid transfer unit body.

[0248] Optionally, fluid transfer unit identification unit 365 determines fluid transfer unit characteristics based on identification information visible in an image of a particular fluid transfer assembly 119. For example, identification information (suitably extracted through image processing) identifies fluid transfer assembly 119 by type, and the type is used to select fluid transfer unit type data that provides associated fluid transfer unit characteristics. Image processing techniques used to extract identification information include, for example, line detection, thresholding, spatial frequency filtering based on convolution and / or FFT, pattern matching, and / or image metrology. Optionally, illumination is controlled to selectively highlight fluid transfer assembly 119 and / or its components, for example, using backlighting, front lighting, and / or patterned lighting. Additionally or alternatively, fluid transfer unit identification unit 365 determines fluid transfer unit type through methods such as machine learning classification (e.g., using a library such as YOLO5). In some examples, fluid transfer unit identification unit 365 utilizes fluid transfer unit geometry measurement capabilities provided by fluid transfer unit geometry measurement unit 375, or implements such capabilities itself.

[0249] In some examples, fluid transfer unit geometry measurement unit 375 implements one or both of the following: (1) the ability to measure parameters of the overall (e.g., "normal") geometry of fluid transfer assembly 119, and / or (2) the ability to detect changes and / or anomalies in the geometry of fluid transfer assembly 119. Fluid transfer unit geometry measurements can be used to directly determine characteristics of fluid transfer assembly 119, and / or to help identify fluid transfer assembly 119; the identification itself being used, for example, as described with respect to fluid transfer unit identification unit 365.

[0250] Examples of overall geometric parameters include the diameter of the fluid transfer unit (e.g., of any suitable portion of the fluid transfer unit body 121 and / or the fluid transfer unit connection end 122 and / or the fluid transfer connector 126), the length of the fluid transfer unit (e.g., of the fluid transfer unit body 121), shapes of the fluid transfer unit components (e.g., shapes such as the angle of the conical surface of the piston 123 and / or the fluid transfer unit connection end 122, and shapes such as the wall thickness of the fluid transfer unit body 121), and / or the relative positioning of the plunger 137 and the fluid transfer unit body 121. Finding the relative positioning of the plunger 137 and the fluid transfer unit body 121 may alternatively be understood as, for example, characterizing (as part of a measurement) the volume of the contents of the fluid transfer unit body 121, and / or finding the positioning of the piston 123 within the fluid transfer unit body 121.

[0251] The overall geometric parameters themselves are optionally used as fluid transfer unit characteristics that are taken into account when selecting values ​​for one or more parameters used to manipulate the fluid transfer assembly 119. For example, the relative positioning of the plunger 137 and the fluid transfer unit body 121 provides information about how much further the plunger 137 can be advanced relative to the fluid transfer unit body 121, and / or how much the plunger 137 can be withdrawn from the fluid transfer unit body 121. One or both of these distances can be used to define a constrained range of motion, and the target movement (e.g., injecting a certain volume or withdrawing a certain volume) can optionally be compared to the constrained range of motion to ensure that it is consistent with the constrained range. This state is optionally used to determine whether corrective action is needed, such as one or more of: suspending manipulation of the fluid transfer unit, reducing the target movement distance, and adjusting the drug preparation plan with respect to the manipulation of an additional fluid transfer unit (e.g., a fluid transfer unit to make up for the volume shortage that would result from using the current fluid transfer unit).

[0252] In another example, the wall thickness of the fluid transfer unit 120 can be used as a characteristic associated with a reliability limit for the maximum pressure that can be applied to the fluid transfer unit during operation of the fluid transfer unit 120. In another example, the inner diameter of the fluid transfer unit 120 (e.g., the outer diameter minus twice the wall thickness) optionally indicates the volume transferred per unit length of movement of the plunger 137, which can be used to determine how much the plunger 137 should move.

[0253] 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 verify the absence of such conditions.

[0254] In one set of examples, the position of the fluid transfer assembly 119 relative to some (e.g., target or incorrect) positioning state is checked. More specific examples include, for example, the state of engagement with the clamp 130, the plunger arm 125, and / or the fluid transfer connector 126. Other more specific examples include detecting the position and / or configuration of the fluid transfer assembly 119 (e.g., within a fluid transfer assembly reservoir 100, such as a fluid transfer assembly carousel) for planning movement of the clamp 130 and / or the plunger arm 125 to engage the fluid transfer assembly 119, and / or verifying the correctness of the planned movement. Another example of this type is verifying that the expected position of the plunger 137 relative to the fluid transfer unit body 121 (e.g., expected based on previously given motion commands and / or encoder measurements) matches what is actually visible in the image.

[0255] In another set of examples, deformation of the fluid transfer assembly 119 is examined. Causes of deformation include, for example, deformation due to pressure from the holder 130 and deformation due to a mismatch between the pressure applied to the plunger 137 and the rate at which fluid can flow out of the fluid transfer unit body 121. Types of deformation include, for example, bending and / or twisting of the plunger shaft, or expansion of the body of the fluid transfer unit.

[0256] Deformation (at least to some extent) may be conventionally expected and / or indicative of proper operation. Additionally or alternatively, deformation (e.g., excessive deformation) may indicate a malfunction or the likelihood of a malfunction occurring; for example, a blockage in flow, an incorrectly implemented clamping diameter, and / or an incipient loss of containment integrity due to leakage and / or bursting.

[0257] Optionally, deformation is detected and / or measured directly from a single image, for example, by applying suitable image processing techniques, such as those listed for fluid transfer unit identification. Additionally or alternatively, the fluid transfer unit geometry measurement unit 375 determines fluid transfer unit deformation by methods such as machine learning classification. Optionally, special illumination (e.g., polarized light) is used to assist in deformation detection, for example, by exploiting stress-induced birefringence.

[0258] In some examples, differential image processing is used to detect differences between, for example, a pressurized state and an unpressurized state of the fluid transfer unit 120, and / or the state of the fluid transfer assembly 119, before and during a manipulation (and / or after the 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 the walls of the fluid transfer unit 120 viewed against a contrasting background.

[0259] Using methods that are sufficiently sensitive to deformation to detect deformation associated with the intended function of the PPS 99 and fluid transfer assembly carrier 105 provides potential advantages by generating data that can guide manipulation as it occurs. For example, the rate of fluid transfer can optionally be dynamically adjusted to maintain the level of deformation within an appropriate range (e.g., effective for the type of fluid transfer unit) without necessarily requiring a reduction in the maximum speed of the plunger 137 (or a relatively reduced reduction) to account for unknown variability in the viscosity of the fluid contents, the manufacture of the fluid transfer unit 120, or other sources of variability.

[0260] In another set of examples, images obtained by the imager 240 are used to detect movement of the fluid transfer unit 120 and / or elements connected to the fluid transfer unit 120 (such as the fluid transfer connector 126). Detection of these movements can be performed by applying illumination and / or image analysis techniques, for example, as described with respect to deformation detection. During manipulation of the fluid transfer assembly 119, rotational and / or translational movement of certain elements (e.g., the fluid transfer unit body 121 and / or the fluid transfer connector 126) may indicate improper engagement with the fluid transfer assembly carrier 105, and / or improperly configured attachment of the fluid transfer connector 126 to the fluid transfer unit connection end 122, for example. Detecting such movements is potentially advantageous because they may be a precursor to a fault condition, such as a fluid leak, and / or be associated with an actual leak.

[0261] In another set of examples, images obtained by the imager 240 are used to detect and / or measure properties of the fluid transfer unit 120 associated with its fluid contents. Detection of these movements can be performed by applying illumination and / or image analysis techniques, e.g., as described with respect to deformation detection. More specific examples of this group include fluid leaks, which may appear in images in different forms, depending on the nature of the fault. For example, image analysis may reveal the presence of fluid droplets, or changes in the reflectivity of the fluid transfer assembly 119 due to wetting. Optionally, one or more jet capture surfaces are placed near areas of particular concern (e.g., near connectors), the capture surfaces being configured to change contrast when wetted to allow for easy detection of potentially larger energy leaks when the fluid transfer assembly 119 is under pressure.

[0262] Method of operating a drug preparation system

[0263] Property-dependent modification of fluid transfer unit-fluid transfer unit junctions

[0264] Now refer to Figure 4A, which shows a flowchart of an example method of clamping a fluid transfer unit by a clamp according to some examples of the present disclosure, wherein the clamping is optimized for determined fluid transfer unit type data. Figure 4A The method can be considered as Figure 1A In general, it should be understood that Figures 4A-4C The operations of any of the methods are optionally performed together within the same PPS 99, and optionally performed together in any suitable combination during manipulation of the same fluid transfer assembly 119, optionally using at least some of the same images.

[0265] In some examples, at block 410A, the processing circuitry 217 (e.g., imager interface unit 355) acquires (e.g., receives) one or more images (e.g., digital images) of the fluid transfer assembly 119; for example, as captured by the imager 240 at an imager distance 295. The specification of the imager distance 295 (e.g., as a "particular distance") is related to operations that are sensitive to focus and / or scale. The specific use of the imager distance 295 need not be used in all examples of the present disclosure; for example, the focus can be determined based on the image spatial frequency content, and / or the scale can be determined based on the size of reference elements depicted in one or more images. For example, scale markings can be placed adjacent to the fluid transfer assembly 119, and / or scale markings on the fluid transfer unit 120 itself of known size and / or spacing can be used in the calculations.

[0266] In some examples, at block 420A, the processing circuitry 217 (e.g., the fluid transfer unit identification unit 365) processes the one or more images to determine fluid transfer unit characteristics. As non-limiting examples, the processing circuitry 217 (e.g., the fluid transfer unit identification unit 365) may utilize an image processing method such as line detection or machine learning (and / or another image processing method, such as, for example, a method for detecting a fluid transfer unit). Figure 1A and / or Figure 3B In some examples, the fluid transfer unit characteristics are generated and / or obtained in the form of a data structure containing fluid transfer unit model data (e.g., fluid transfer unit body length, thickness, circumference, manufacturer, and / or model).

[0267] In some examples, at box 430A, the processing circuit system 217 and / or the clamping control unit 335 controls the clamper 130 to clamp the fluid transfer unit using a clamper jaw diameter and / or at a body position selected based on determined fluid transfer unit characteristics (e.g., fluid transfer unit model data, or another form of data representing fluid transfer unit characteristics).

[0268] As a non-limiting example: As described above, the preferred placement of the gripper along the fluid transfer unit body optionally depends on one or more fluid transfer unit characteristics; for example, the fluid transfer unit length, circumference, manufacturer, and / or other considerations. Thus, in some examples, the processing circuitry 217 and / or the gripper control unit 335 controls the gripper 130 to position it at a specific location along the fluid transfer unit body 121 that is consistent with the fluid transfer unit characteristics (e.g., fluid transfer unit model data).

[0269] As another non-limiting example: As described above, the preferred gripper jaw diameter used by the 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 other considerations. Thus, in some examples, the processing circuit system 217 (e.g., by issuing commands to the gripper control unit 335) controls the gripper 130 to grip using a specific gripper jaw diameter value that is consistent with the fluid transfer unit characteristics (e.g., fluid transfer unit model data). For example, the gripper jaw diameter value can be selected to be equal to or slightly adjusted relative to the diameter of the fluid transfer assembly 119 at the clamped location. Smaller values ​​can be used, for example, to help ensure a tight grip, thereby allowing for a certain amount of compression. Equal or greater values ​​may be more appropriate for a fluid transfer assembly 119 constructed of a relatively incompressible material, and / or where the fluid transfer assembly 119 is constrained primarily by its shape (e.g., the widening portion of the fluid transfer unit connection end 122 below the clamping position used by the clamp 130) rather than by friction.

[0270] It should be understood that Figure 4A The methods of represent a class of methods related to the engagement of the fluid transfer assembly 119 by the fluid transfer assembly carrier 105. For example, Figure 4A The examples relate to values ​​of parameters related to the operation of the gripper 130. It should be understood that the same set of operations, with appropriate variations, are optionally performed with respect to values ​​of parameters related to the operation of the plunger arm 125 when engaging the plunger 137 of the fluid transfer unit 120, and / or values ​​of parameters related to the operation of the fluid transfer assembly transporter 105 itself, for example, values ​​of parameters related to its positioning relative to a fluid transfer assembly 119 held in a fluid transfer assembly reservoir 100 (e.g., a linear or rotating disk type fluid transfer assembly reservoir 100).

[0271] Fluid Transfer Unit - Property-Dependent Modification of Plunger Operation

[0272] Now refer to Figure 4B, which illustrates a flow chart of an example method for drawing fluid into or injecting fluid from a fluid transfer unit, wherein the drawing or injecting is selected based on 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 with reference to a specific type of fluid transfer assembly 119). Figure 4B The method can be considered as Figure 1A 4. An example of a method of claim 1, wherein the operation of block 430B is one example corresponding to the operation of block 54, and the operation of block 440B is another example corresponding to the operation of block 54.

[0273] In some examples, at block 410B, the processing circuitry 217 (e.g., imager interface unit 355) acquires one or more images of the fluid transfer unit; for example, one or more images captured by the imager 240 at the imager distance 295. Figure 4A The description of imager distance 295 for block 410A should be understood to also apply to block 410B.

[0274] In some examples, at block 420B, the processing circuitry 217 (e.g., fluid transfer unit identification unit 365) processes the image of block 410B to determine fluid transfer unit characteristics, for example, in the form of fluid transfer unit model data or in another form. As a non-limiting example, the processing circuitry 217 (e.g., fluid transfer unit identification unit 365) optionally utilizes any suitable image processing method (e.g., as described with respect to Figure 1A and / or Figure 3B The fluid transfer unit characteristics may be determined using image-based measurements and / or 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.

[0275] In some examples, at box 430B, the processing circuit system 217 and / or the plunger arm control unit 345 controls the plunger arm 125 to move the fluid transfer unit plunger 137 into or out of the fluid transfer unit body 121 a specific distance, where the speed of the plunger is optimized based on the determined fluid transfer unit model data.

[0276] As a non-limiting example, as described above, the preferred speed of plunger movement may optionally depend on any one or more fluid transfer unit characteristics, such as fluid transfer unit length, circumference (diameter), manufacturer, or other considerations. In some examples, the processing circuitry 217 and / or plunger arm control unit 345 determines the target speed based on a table or other data structure that associates fluid transfer unit type and / or fluid transfer unit geometry with appropriate target speed values. Additionally or alternatively, the processing circuitry 217 and / or plunger arm control unit 345 determines the target speed via another mechanism, such as machine learning classification. In some examples, the processing circuitry 217 and / or plunger arm control unit 345 further utilizes the viscosity of the fluid being drawn to determine the target speed, for example, as provided as a further data input and / or as empirically determined, for example, through test manipulations of the manipulated fluid transfer assembly 119 and / or example fluid transfer assemblies 119 (e.g., fluid transfer assemblies 119 filled with fluid believed to be representative of the contents of multiple other fluid transfer units 120 in terms of their viscosity).

[0277] In some examples, at block 440B, the processing circuitry 217 and / or the plunger arm control unit 345 optionally measures the actual effective push / pull velocity of the fluid transfer unit plunger 137. For example, this velocity can be measured by acquiring multiple images that are sometimes separated by the movement of the plunger 137 and measuring the distance moved based on these images. For example, the average velocity can be obtained by image processing successive images of the fluid transfer unit during the push / pull operation.

[0278] Additionally or alternatively, in some examples, the processing circuitry 217 and / or plunger arm control unit 345 determines the actual average push / pull speed by reading from register 320B, e.g., as described with respect to Figure 3A In some examples, the processing circuitry 217 and / or the plunger arm control unit 345 receives image data from the imager controller 230 that indicates the actual average push / pull speed.

[0279] Potentially, any one or more of several factors may potentially cause the actual average speed of the plunger movement to be lower than the target (and commanded) speed. These factors include, for example, the viscosity of the fluid being pumped / injected, the thickness of the connector septum 131, or other factors. Potentially, values ​​representing one or more of these factors may be used as fluid transfer unit characteristics, for example, fluid transfer unit characteristics associated with a particular fluid transfer unit type.

[0280] Optionally, if it is determined at box 440B that the actual average push / pull speed of the fluid transfer unit plunger 137 does not match the target speed (e.g., it is lower than the target speed by a specific threshold), the processing circuit system 217 and / or the plunger arm control unit 345 can, for example, optionally reduce the target speed to match the effective speed, stop operating the fluid transfer assembly 119, and / or generate a message signal such as a warning or alarm (e.g., text, graphical indication and / or sound).

[0281] Fluid transfer unit attachment monitoring

[0282] Now refer to Figure 4C , which illustrates a flow chart of an example method for determining whether a fluid transfer connector is properly attached to a fluid transfer unit using 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 with reference to a specific type of fluid transfer assembly 119). Figure 4C The method can be considered as Figure 1A 54, wherein the operations of blocks 430C and 440C together provide an example of operations corresponding to block 54.

[0283] In some examples, at block 410C, the processing circuitry 217 (e.g., the imager interface unit 355) acquires one or more images of the fluid transfer unit; for example, one or more images captured by the imager 240 at the imager distance 295. Figure 4A The description of imager distance 295 for block 410A should be understood to also apply to block 410B.

[0284] In some examples, at block 420C, processing circuitry 217 (e.g., fluid transfer unit identification unit 365) processes the image of block 410C to determine fluid transfer unit characteristics, for example, in the form of fluid transfer unit model data or in another form. As a non-limiting example, processing circuitry 217 (e.g., fluid transfer unit identification unit 365) optionally utilizes any suitable image processing method (e.g., as described with respect to Figure 1A and / or Figure 3B The fluid transfer unit characteristics may be determined using image-based measurements and / or 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.

[0285] In some examples, at block 430C, processing circuitry 217 and / or fluid transfer unit identification unit 365 determines, based on the digital image, the length of a portion of the cannula of fluid transfer assembly 119 (e.g., a needle of fluid transfer assembly 119), the position of plunger 137, and / or the position of piston 123. The determined length and / or position indicates the available range of motion of plunger 137; for example, the amount of fluid that can be injected from fluid transfer unit 120, and / or the amount of volume that can be filled in fluid transfer unit 120 from a fluid container 175 (e.g., vial 115 or IV bag 116).

[0286] In some instances, for example, the exposed sleeve length is the length of exposed metal extending through the fluid transfer connector 126 beyond the fluid transfer unit connection end 122, or optionally the portion of this length of exposed sleeve extending beyond the fluid transfer connector 126 itself.

[0287] The processing circuitry 217 (e.g., fluid transfer unit identification unit 365) compares the determined length and / or position to a threshold for the position. For example, in the case of a cannula, the threshold indicates how much metal should be exposed if the fluid transfer connector is properly attached to the fluid transfer unit. This threshold can be a derivative of, or otherwise consistent with, the determined fluid transfer unit characteristics; for example, the appropriate length of exposed cannula optionally varies depending on the type of fluid transfer unit.

[0288] In some examples, at block 440C, if the determined length is outside the limits set by the threshold, this indicates that the fluid transfer connector 126 is improperly attached to the fluid transfer unit 120. Optionally, the processing circuitry 217 (e.g., syringe identification unit 365) provides a signal that causes appropriate handling of this situation, such as issuing an alarm.

[0289] Overview

[0290] As used herein, with respect to quantities or values, the term "about" means "within ±10% of."

[0291] The terms "comprises," "comprising," "includes," "including," "having" and their listed conjugations mean: "including but not limited to."

[0292] The term "consisting of" means: "including and limited to."

[0293] 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.

[0294] As used herein, the singular forms "a / an" and "the" include plural referents unless the context clearly indicates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0295] As used herein, the words “example” and “exemplary” 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 of other embodiments.

[0296] The word “optionally” is used herein to mean “provided in some embodiments and not provided in other embodiments.” Any particular embodiment of the present disclosure may include a number of “optional” features, except to the extent such features conflict.

[0297] As used herein, the term "methodology" refers to manners, means, techniques and procedures for accomplishing a given task, including but not limited to those manners, means, techniques and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine or which are readily developed based on known manners, means, techniques and procedures.

[0298] As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of clinical or aesthetic symptoms of a condition.

[0299] Throughout this application, the embodiments can be presented with reference to the range format. It should be understood that the description using the range format is only for the sake of convenience and brevity, and should not be interpreted as a hard limit to the description range of the present disclosure. Therefore, the description of the range should be considered to have specifically disclosed all possible sub-ranges and individual numerical values ​​within the range. For example, the description of a range such as "1 to 6" should be considered to have specifically disclosed sub-ranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", and individual numbers within the range, such as 1, 2, 3, 4, 5 and 6. This applies regardless of the width of the range.

[0300] Whenever a numerical range is indicated herein (e.g., "10-15," "10 to 15," or any pair of numbers connected by such another range indicator), it is meant to include any number (fractional or integer) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases "ranges between" a first and a second indicating number and "to," "up to," "until," or "through" (or another such range-indicating term) a first indicating number and a second indicating number are used interchangeably herein and are meant to include the first and second indicating numbers and all fractions and integers therebetween.

[0301] Although the present disclosure has been described in conjunction with specific embodiments, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. It is therefore intended to encompass all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0302] It should be understood that, for the sake of clarity, certain features described in the context of separate embodiments in this disclosure may also be provided in combination in a single embodiment. Conversely, for the sake of simplicity, different features described in the context of a single embodiment may also be provided in any other described embodiment of the disclosure, alone or in any suitable subcombination or where appropriate. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment does not function without those elements.

[0303] It is the intention of the applicant that all publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the same extent as if each individual publication, patent, or patent application were specifically and individually indicated as being incorporated herein by reference when cited. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art for the present disclosure. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document of the present application is hereby incorporated herein by reference in its entirety.

Claims

1. A fluid transfer assembly handling subsystem of a pharmaceutical preparation system (PPS), the subsystem comprising: a holder configured to hold a fluid transfer assembly; a fluid pump that operates to cause fluid transfer into or out of the fluid transfer assembly based on pressure applied by the fluid pump when the fluid transfer assembly is held by the holder; as well as processing circuitry, the processing circuitry comprising a processor and a memory, the memory storing instructions instructing the processor to: acquiring at least one image of the fluid transfer assembly; processing the image to determine at least one characteristic of the fluid transfer assembly; and commanding at least one of the gripper and the fluid pump to operate the fluid transfer assembly according to at least one value of at least one corresponding operating parameter; wherein the at least one value of the at least one corresponding operating parameter is selected based on 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 when the holder 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 that illuminates the fluid transfer assembly from an angle that can be adjusted between images as 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 to 3, comprising an illumination source that 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 handling subsystem of any one of claims 2 to 4, wherein the at least one imager images the fluid transfer assembly in at least two different positions to generate the at least one image.

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

7. A fluid transfer assembly manipulation subsystem according to any one of claims 2 to 6, wherein at least one image comprises a plurality of images, and the processing circuit system uses a differential image generated using the plurality of images to determine the at least one characteristic of the fluid transfer assembly.

8. A fluid transfer assembly manipulation subsystem according to any one of claims 2 to 7, comprising an illumination source that backlights the fluid transfer assembly from the perspective of the at least one imager when the at least one imager images the at least one image of the fluid transfer assembly.

9. The fluid transfer assembly manipulation subsystem according to any one of claims 1 to 4, wherein: When processing the image, the processing circuitry: determining a type of the fluid transfer assembly using the at least one image; selecting fluid transfer assembly model data using the type; and The at least one characteristic is determined using the selected fluid transfer assembly model data.

10. The fluid transfer assembly manipulation subsystem of claim 9, wherein: When processing the image, the processing circuitry uses a machine learning-based classification of the image to determine the type.

11. The fluid transfer assembly manipulation subsystem according to any one of claims 9 to 10, wherein: When processing the images, 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 according to any one of claims 9 to 11, wherein: When processing the images, the processing circuitry determines the type using the appearance in the at least one image of at least one of: scale markings on the fluid transfer assembly; a logo mark on the fluid transfer assembly; as well as A pattern encoding a digital value is marked on the fluid transfer assembly.

13. The fluid transfer assembly manipulation subsystem according to any one of claims 9 to 12, wherein: When processing the images, the processing circuitry determines the type using geometric shapes appearing in the at least one image, the geometric shapes comprising at least one of: the shape of the piston of the fluid transfer assembly; the shape of the shaft of the fluid transfer assembly; the shape of the apex of the body of the fluid transfer unit of the fluid transfer assembly; and The shape of the flange of the body.

14. The fluid transfer assembly manipulation subsystem of any one of claims 1 to 10, wherein: When processing the image, the processing circuitry: 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 The at least one characteristic is determined using the generated fluid transfer assembly model data.

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

16. The fluid transfer assembly manipulation subsystem of any one of claims 9 to 14, wherein: When processing the image, the processing circuitry determines the at least one value based on a machine learning classification of the fluid transfer assembly model data.

17. The fluid transfer assembly handling subsystem of any one of claims 1 to 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 clamping diameter of the clamp.

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

19. The fluid transfer assembly manipulation subsystem of any one of claims 1 to 18, wherein: The at least one characteristic comprises a designated clamping position of the fluid transfer assembly; and The at least one operating parameter includes a clamped position of the fluid transfer assembly targeted to the designated clamped position.

20. The fluid transfer assembly handling subsystem of any one of claims 1 to 19, wherein the fluid pump comprises a plunger arm configured to move a plunger of the fluid transfer assembly when clamped.

21. The fluid transfer assembly manipulation subsystem of claim 20, wherein: The at least one characteristic comprises the relative positioning 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 positioning when at least one of: controlling the delivery of a fluid using the fluid delivery assembly; and Verify the transfer.

22. The fluid transfer assembly handling subsystem of claim 21, wherein the at least one operating parameter comprises a target connection positioning of the plunger arm relative to the plunger.

23. A fluid transfer assembly manipulation subsystem according to any one of claims 21 to 22, wherein at least one of the operating parameters includes a target linear distance moved by the plunger when connected to the plunger arm, the target linear distance being determined based on a target volume of the fluid to be transferred.

24. The fluid transfer assembly manipulation subsystem of any one of claims 21 to 23, wherein the at least one characteristic comprises a constrained range of permissible relative positioning of a body and the plunger of a fluid transfer unit of the fluid transfer assembly, the constrained range of permissible relative positioning being selected to be consistent with an available range of motion of the plunger relative to the body; and the instructions instruct the processor to: obtaining a target linear movement distance of the plunger relative to the body; and Determine a state indicating whether the target linear movement distance is consistent with both of the following: the relative positioning of the body and the plunger; and A constrained range of the permissible relative positioning of the body and the plunger.

25. The fluid transfer assembly manipulation subsystem of claim 24, wherein: When the status indications are inconsistent, the processor is instructed to perform at least one of the following: ceasing operation of the fluid transfer assembly; reducing the target linear distance; and The plan for drug preparation is adjusted relative to the manipulation of additional fluid transfer assemblies.

26. The fluid transfer assembly manipulation subsystem of any one of claims 20 to 25, wherein the at least one characteristic determined from the at least one image of the fluid transfer assembly comprises a flow resistance associated with the fluid transfer assembly; and the instructions instruct the processor to: obtaining a value indicative of a viscosity of a fluid transferred using the fluid transfer assembly; and determining a target velocity for linear movement of the plunger relative to a body of a fluid transfer unit of the fluid transfer assembly; The target speed is determined based on the value indicating the viscosity of the fluid and the flow resistance of the fluid transfer assembly, and based on an upper limit of pressure generated within the fluid transfer assembly during the linear movement of the plunger.

27. The fluid transfer assembly handling subsystem of claim 26, wherein the at least one characteristic comprises an upper pressure rating of the fluid transfer assembly, and the upper pressure limit is determined based on the upper pressure rating.

28. The fluid transfer assembly manipulation subsystem of claim 26, wherein the at least one characteristic comprises a target operating pressure for the fluid transfer assembly, and a target speed of the linear movement of the fluid transfer assembly is determined based on the target operating pressure.

29. The fluid transfer assembly manipulation subsystem of any one of claims 26 to 27, wherein: The instructions instruct the processor to obtain a vapor pressure of the fluid transferred using the fluid transfer assembly; and The target speed is further determined based on the vapor pressure of the fluid and based on a lower limit of pressure generated within the fluid transfer assembly during the linear movement of the plunger.

30. The fluid transfer assembly handling subsystem of any one of claims 1 to 29, comprising a fluid transfer assembly transporter configured to engage a fluid transfer assembly with the fluid transfer assembly handling subsystem.

31. A fluid transfer assembly handling subsystem according to any one of claims 1 to 30, comprising a vial holder configured to position a vial at one or more positions that enable the held vial to be interconnected with a fluid transfer assembly being handled by the fluid transfer assembly handling subsystem.

32. The fluid transfer assembly manipulation subsystem of any one of claims 1 to 31, wherein: the at least one image comprising 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.

33. The fluid transfer assembly manipulation subsystem of claim 32, wherein: the processing circuitry scanning the at least one image of the fluid transfer assembly imaged during manipulation of the fluid transfer assembly to detect one or more adverse conditions; and Upon detection, a signal is generated indicative of the one or more adverse conditions.

34. The fluid transfer assembly handling subsystem of claim 33, wherein the one or more scanned adverse conditions include at least one of: rotation of a body of a fluid transfer unit of the fluid transfer assembly; movement of the body along the longitudinal axis of the body; Change in shape of the body; and The shape of the plunger of the fluid transfer unit changes.

35. A fluid transfer assembly manipulation subsystem according to claim 34, wherein the one or more adverse conditions scanned include at least one of the shape changes, which is determined using a 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 handling subsystem of claim 33, wherein the fluid transfer assembly includes a fluid transfer connector that is attached to the fluid transfer unit during movement of a plunger of the fluid transfer unit, and the one or more scanned adverse conditions include at least one of the following: The visible length of a portion of the body of the fluid transfer unit is incorrectly measured; a portion of the body being an incorrect distance from a portion of the fluid transfer connector; relative movement of the body and the fluid transfer connector; and Fluid leakage associated with the junction between the body and the fluid transfer connector.

37. The fluid transfer assembly handling subsystem of any one of claims 33 to 36, comprising the PPS, wherein the PPS generates an alarm upon receipt of the signal.

38. A fluid transfer assembly manipulation subsystem according to any one of claims 32 to 37, wherein 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 the plunger that is different from a target velocity of the plunger.

39. A method of configuring a fluid transfer assembly handling subsystem of a medication preparation system (PPS), the fluid transfer assembly handling subsystem comprising a holder configured to hold a fluid transfer assembly and a fluid pump, the holder configured to hold a fluid transfer assembly, the fluid pump operating to facilitate fluid transfer into or out of the fluid transfer assembly based on pressure applied by the pump when the fluid transfer assembly is held; 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 operate the fluid transfer assembly according to at least one value of at least one corresponding operating parameter; wherein the at least one value of the at least one corresponding operating parameter is selected based on the determined at least one characteristic.

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

41. The method according to any one of claims 39 to 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 The at least one characteristic is determined using the selected fluid transfer assembly model data.

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

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

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

45. The method of any one of claims 39 to 41, wherein 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 The at least one characteristic is determined using the generated fluid transfer assembly model data.

46. ​​The method of any one of claims 39 to 45, wherein the fluid pump comprises a plunger arm and the command commands movement of a plunger of the fluid transfer assembly when clamped.

47. The method of claim 46, wherein: The at least one characteristic comprises the relative positioning of a body of a fluid transfer unit of the fluid transfer assembly and the plunger; and The method comprises using the relative positioning when at least one of: controlling the delivery of a fluid using the fluid delivery assembly; and Verify the transfer.

48. The method of claim 47, wherein the at least one characteristic comprises a constrained range of permissible relative positioning of a body of a fluid transfer unit of the fluid transfer assembly and the plunger, the constrained range of permissible relative positioning being selected to be consistent with an available range of motion of the plunger relative to the body; and the method comprising: obtaining a target linear movement distance of the plunger relative to the body; and Determine a state indicating whether the target linear movement distance is consistent with both of the following: the relative positioning of the body and the plunger; and A constrained range of the permissible relative positioning of the body and the plunger.

49. The method of any one of claims 46 to 48, wherein the at least one characteristic determined from the at least one image of the fluid transfer assembly comprises a flow resistance associated with the fluid transfer assembly; and the method comprises: obtaining a value indicative of a viscosity of a fluid transferred using the fluid transfer assembly; and determining a target velocity for linear movement of the plunger relative to a body of a fluid transfer unit of the fluid transfer assembly, the determining being: Based on the value indicative of the viscosity of the fluid and the flow resistance of the fluid transfer assembly; and According to an upper pressure limit 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, the program instructions, when read by a processor, causing processing circuitry to perform a method for configuring fluid transfer assembly handling in a medication preparation system (PPS), the fluid transfer assembly handling subsystem comprising a gripper and a fluid pump, the gripper configured to grip a fluid transfer assembly, the fluid pump operating to facilitate fluid transfer into or out of the fluid transfer assembly based on pressure applied by the fluid pump when the fluid transfer assembly is gripped; and wherein the method comprises: using, by processing circuitry, the image of the fluid transfer assembly to determine at least one characteristic of the fluid transfer assembly; and commanding at least one of the gripper and the fluid pump to operate the fluid transfer assembly according to at least one value of at least one corresponding operating parameter; wherein the at least one value of the at least one corresponding operating parameter is selected based on the determined at least one characteristic.

Images