Imaging-based verification of sequence of robotic pharmaceutical preparation

Abstract

Safety-enhanced pharmaceutical preparation devices, configured to exchange contents among one or more containers to prepare a pharmaceutical dose in a receiving container. The exchanges of contents are performed using one or more robotic fluid transfer actuators, operable to manipulate the one or more containers to prepare the pharmaceutical dose. The pharmaceutical preparation devices lock a pharmaceutical dose in preparation into place, unlocking it (to free it for its intended use) upon determining that the pharmaceutical dose includes (e.g., displays or otherwise presents) identifying data consistent with the specifications of the dose prepared.

Description

[0001] IMAGING-BASED VERIFICATION OF SEQUENCE OF ROBOTIC

[0002] PHARMACEUTICAL PREPARATION

[0003] RELATED APPLICATIONS

[0004] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 605,542 filed on December 3, 2023, the contents of which are incorporated herein by reference in their entirety.

[0005] FIELD AND BACKGROUND OF THE INVENTION

[0006] The present invention, in some embodiments thereof, relates to the field of imaging in robotics and more particularly, but not exclusively, to specification and / or verification of robotic preparation of pharmaceutical doses.

[0007] Problems of specification and verification in systems of robotic injection preparation have been recognized in the conventional art. Various techniques have been developed to provide solutions.

[0008] SUMMARY OF THE INVENTION

[0009] According to an aspect of some examples of the presently described subject matter, there is provided a safety-enhanced pharmaceutical preparation device configured to exchange contents among one or more containers to prepare a pharmaceutical dose provided in a receiving container, the device comprising: one or more identification devices operable to sense identifier patterns; a container lock; and processing circuitry and memory, the memory including instructions which configure the processing circuitry to: obtain, using the one or more identification devices, specification data indicative of specified contents of a pharmaceutical dose, lock the receiving container into the pharmaceutical preparation device, using the container lock, control the pharmaceutical preparation device to prepare the pharmaceutical dose, responsive to completion of preparation, operate the one or more identification devices to obtain completed-state identifying data identifying the receiving container including the prepared pharmaceutical dose, determine that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose, and unlock the container lock, in accordance with the determination.

[0010] According to some examples of the presently described subject matter, the processing circuitry determines that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose through a comparison using the completed- state identifying data and the specification data.

[0011] According to some examples of the presently described subject matter, the comparison checks for identity of the completed-state identifying data and the specification data.

[0012] According to some examples of the presently described subject matter, the pharmaceutical preparation device comprises one or more robotic fluid transfer actuators, and the processing circuitry controls the robotic fluid transfer actuators so that the receiving container contains the pharmaceutical dose upon completion of preparation.

[0013] According to some examples of the presently described subject matter, the one or more identification devices are positioned to image a carrier attached to the locked-in receiving container to obtain the completed-state identifying data.

[0014] According to some examples of the presently described subject matter, the one or more identification devices are configured to image the specification data from the carrier, before the receiving container is locked into the pharmaceutical preparation device.

[0015] According to some examples of the presently described subject matter, the carrier is a sticker, transferred to the receiving container to provide the completed-state identifying data after the processing circuitry obtains the specification data.

[0016] According to some examples of the presently described subject matter, the one or more identification devices comprise at least one optical camera, and the identifying data comprise at least one image obtained using the optical camera.

[0017] According to some examples of the presently described subject matter, the processing circuitry uses image processing to determine that the identifying data are indicative of the specified contents of the pharmaceutical dose.

[0018] According to some examples of the presently described subject matter, the container lock comprises a fluid exchange connector which the pharmaceutical preparation device removes from the receiving container to unlock the container lock.

[0019] According to some examples of the presently described subject matter, the container lock comprises one or more robotic fluid transfer actuators, positioned to prevent removal of the receiving container from the pharmaceutical preparation device when the container lock is locked.

[0020] According to some examples of the presently described subject matter, the container lock includes a bypass option operable to unlock the receiving container before the processing circuitry determines that the identifying data are indicative of the specified contents of the pharmaceutical dose; and operation of the bypass option results in a tell-tale of the operation of the bypass being placed upon the receiving container.

[0021] According to some examples of the presently described subject matter, the processing circuitry is further configured to: obtain the specification data as a specification identifier of the pharmaceutical dose; transmit the specification identifier to a control server; receive data specifying contents of the pharmaceutical dose from the control server, in response to the identifier; and transmit an indication of successful pharmaceutical preparation completion to the control server; wherein receipt of the data specifying contents of the pharmaceutical dose in exchange for the specification identifier avoids access by the pharmaceutical preparation device to personally identifying electronic medical records.

[0022] According to some examples of the presently described subject matter, the processing circuitry is configured to lock the receiving container responsive to an instruction from the control server.

[0023] According to some examples of the presently described subject matter, the data indicative of specified contents of a pharmaceutical dose comprise an identifier received from a control server.

[0024] According to some examples of the presently described subject matter, the data indicative of specified contents of a pharmaceutical dose comprise an identifier provided to the control server, the identifier specifying at least in part a present capability of the pharmaceutical preparation device.

[0025] According to some examples of the presently described subject matter, the identifying data comprise a label printed according to data received from the control server.

[0026] According to some examples of the presently described subject matter, the data indicative of the specified contents of the pharmaceutical dose comprise a scan of a label comprising at least one of: a barcode, a QR code, and identifier text.

[0027] According to some examples of the presently described subject matter, the label is a sticker.

[0028] According to an aspect of some examples of the presently described subject matter, there is provided the device wherein the label is also used as the identifying data obtained responsive to completion of preparation.

[0029] According to some examples of the presently described subject matter, the processing circuitry is configured to lock the receiving container before initiating pharmaceutical preparation. According to some examples of the presently described subject matter, the processing circuitry is configured to lock the receiving container subsequent to initiating pharmaceutical preparation.

[0030] According to an aspect of some examples of the presently described subject matter, there is provided a method of controlling release of pharmaceutical preparations automatically prepared by a pharmaceutical preparation device configured to exchange contents among one or more containers to prepare a pharmaceutical dose in a receiving container; the method being performed the pharmaceutical preparation device and comprising: obtaining specification data indicative of specified contents of a pharmaceutical dose; locking the receiving container into the pharmaceutical preparation device; controlling the pharmaceutical preparation device to prepare the pharmaceutical dose; responsive to completion of preparation, operating one or more identification devices to obtain completed- state identifying data identifying the receiving container including the prepared pharmaceutical dose; determining that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose; and unlocking the container lock, in accordance with the determination.

[0031] According to some examples of the presently described subject matter, the specification data and the completed-state identifying data are both obtained from respective images of a same label, and the image of the completed-state identifying data is obtained while the receiving container remains locked into the pharmaceutical preparation device.

[0032] According to some examples of the presently described subject matter, the method comprises: obtaining the specification data as a specification identifier of the pharmaceutical dose; transmitting the specification identifier to a control server; receiving data specifying contents of the pharmaceutical dose from the control server in response to the specification identifier; and transmitting an indication of successful pharmaceutical preparation sequence completion to the control server; wherein receipt of the data specifying contents of the pharmaceutical dose in exchange for the specification identifier avoids access by the pharmaceutical preparation device to personally identifying electronic medical records.

[0033] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, controls. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. As will be appreciated by one skilled in the art, aspects of the present disclosure may be embodied as a system, method, or computer program product. Accordingly, aspects of the present disclosure, as appropriate to the disclosure and to the state of technology, may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system” (e.g., a method may be implemented using “computer circuitry” or “processing circuitry”).

[0034] Furthermore, aspects of some examples of the present disclosure may take the form of a computer program product embodied in one or more computer-readable medium(s) having computer-readable program code embodied thereon. Implementation of the method and / or system of some examples of the present disclosure can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Moreover, in accordance with instrumentation and equipment provided for implementation of some examples of the method(s) and / or system(s) of the present disclosure, selected operations of these methods() and / or system(s) could be variously implemented by hardware, by software, by firmware, and / or by a combination thereof.

[0035] For example, hardware for performing selected operations in accordance with some examples of the present disclosure is optionally implemented as a chip or a circuit. As software, selected operations in accordance with some examples of the present disclosure is optionally implemented as a plurality of software instructions. Optionally, implementation aspects are built on a general-purpose computing device, e.g., making use of the services of an operating system.

[0036] In some examples of the present disclosure, one or more operations performed in method(s) and / or by system(s) are performed by a data processor, such as a computing platform configured to execute pluralities of instructions in sequence and / or concurrently. Such a data processor may be alternatively referred to herein, e.g., as a “digital processor”, in reference to data processors which operate using groups of digital bits, and / or as “processing circuitry” in reference to the use of electronic circuitry in data processing applications.

[0037] Instruction executing elements of a data processor may comprise, for example, one or more microprocessor chips, ASICs, and / or FPGAs. Optionally, the data processor includes a volatile memory for storing instructions and / or data; and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media, for storing instructions and / or data. The terms “non-transitory memory” and “non-transitory storage medium”, where they may be used herein, should be expansively construed to cover any volatile or non-volatile computer memory suitable to the presently disclosed subject matter.

[0038] Optionally, a network connection conferring data communication capabilities is provided. A display and / or a user input device such as a keyboard or mouse are optionally provided. Any of these implementations are referred to herein more generally as instances and / or elements of, e.g., computer circuitry and / or processing circuitry.

[0039] Any combination of one or more computer-readable medium(s) may be used by some examples of the present disclosure. The computer-readable medium may be a computer- readable signal medium or a computer-readable storage medium. Without limitation, a computer-readable storage medium may comprise, for example, an electronic-, magnetic-, optical-, electromagnetic-, infrared-, and / or semiconductor-implemented system, apparatus, or device; in any suitable combination.

[0040] A non-exhaustive list of further examples of computer-readable storage medium(s) includes: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device. Any suitable combination of the foregoing is optionally provided.

[0041] In the context of this document, a computer-readable storage medium may be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device. A computer-readable storage medium may also contain or store information for use by such a program; for example, data structured in the way it is recorded by the computer-readable storage medium so that a computer program can access it as, for example, one or more tables, lists, arrays, data trees, and / or another data structure. Herein a computer-readable storage medium which records data in a form retrievable as groups of digital bits is also referred to as a digital memory. It should be understood that a computer-readable storage medium, in some examples, is optionally also used as a computer writable storage medium, in the case of a computer-readable storage medium which is not readonly in nature, and / or in a read-only state.

[0042] Certain data are optionally referred to herein as being derived form one or more sensors, e.g., as “sensed data” and / or “sensor data”. Such data comprise one or more physical effects transduced into a machine-readable form, e.g., one or more of the computer readable medium(s) described herein. Sensed / sensor data optionally represent physical quantities and / or objects, e.g., measurements and / or images. The sensed data typically are converted to a digital form used in data processing. However, transmitting, maintaining and / or processing sensed data in analog form (e.g., as amplitudes, frequencies, and / or phase encodings of voltage and / or current using suitable analog circuitry; e.g., for operations of comparison and / or combination) is not excluded.

[0043] Herein, a data processor (optionally referred to, e.g., as precessing circuitry and / or computer circuitry) is said to be “configured” to perform data processing actions (e.g.), accessing and / or manipulation of stored and / or streamed data according to one or more algorithmic operations) insofar as it is coupled to a computer-readable medium to receive instructions and / or data therefrom, process them, and / or store processing results in the same or another computer-readable medium. The processing performed (e.g., using the stored and / or streamed data) is specified by the instructions, with the effect that the processor operates according to the instructions. The act of processing may be referred to additionally or alternatively by one or more other terms; for example: comparing, estimating, determining, calculating, computing, comparing, encrypting, decrypting, identifying, associating, storing, accessing, receiving, obtaining, analyzing, selecting, and / or transforming. For example, in some examples, a processing circuitry accesses and / or receives instructions and data stored in volatile and / or non-volatile memory and / or provided over a communication link, processes the data according to the instructions, stores processing results in volatile and / or non-volatile memory, and / or provides processing results. In some examples, “providing” processing results comprises one or more of transmitting, storing and / or presenting processing results. Presenting optionally comprises showing on a display, indicating by sound, printing on a printout, or otherwise producing results in a form accessible to human sensory capabilities.

[0044] A computer-readable signal medium optionally includes a propagated data signal with computer-readable program code embodied therein; for example, in baseband and / or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to: electro-magnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium that is not a computer-readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0045] Program code embodied on a computer-readable medium and / or data used thereby is optionally transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination thereof.

[0046] Computer program code for carrying out operations for some examples of the present disclosure is optionally written in any combination of one or more programming languages; for example, an object-programming, procedural and / or functional programming language. Non-limiting examples include C, Java, Smalltalk, C++, Python, ECMAScript (e.g., JavaScript), and Rust, among many other programming languages known to persons of ordinary skill in the art. As is known to persons of ordinary skill in the art, programs written in such languages specify logical operations which may be variously converted to computer instructions suitable for direct use by particular instances of processing circuitry, before and / or during processing.

[0047] Additionally or alternatively, sequences of logical operations (e.g., in the form of instructions from a machine instruction set supported by processing circuitry) may be embedded in the design of an ASIC and / or in the configuration of an FPGA device. The program code may execute entirely on the user’s computer, partly on the user’s computer (e.g., as a stand-alone software package), partly on the user’s computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user’s computer through any type of network, including a local area network (LAN) or a wide area network (WAN), and / or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

[0048] Some examples of the present disclosure may be described below with reference to one or more flowchart illustrations and / or block diagrams of methods, apparatus (systems) and / or computer program products. For such examples, it will be understood by persons of ordinary skill in the art that each block of the flowchart illustrations and / or block diagrams, along with combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented, to apply teachings provided herein, through use of suitable computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus (e.g., processing circuitry) to produce a machine; such that the instructions, upon their execution, carry out the functions and / or operations specified in the flowchart and / or block diagram block or blocks.

[0049] These computer program instructions may also be stored in a computer-readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer- readable medium produce an article of manufacture including instructions which implement the function / act specified in the flowchart and / or block diagram block or blocks.

[0050] The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0051] Some of the methods described herein are generally designed only for use by a computer; and may not be feasible or practical for performing purely manually by a human expert. A human expert who wanted to manually perform similar tasks, if feasible (e.g., such as inspecting objects, and / or making determinations from data), might be expected to use completely different methods, e.g., making use of human expert knowledge and / or the pattern recognition capabilities of the human brain.

[0052] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0053] Some embodiments of the present disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example, and for purposes of illustrative discussion of embodiments of the present disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

[0054] In the drawings:

[0055] FIG. 1 illustrates an example robotic pharmaceutical preparation device, according to some examples of the present disclosure;

[0056] FIG. 2 illustrates an example of a safety-enhanced pharmaceutical preparation device deployed in communication with a control server and / or medical records system, according to some examples of the present disclosure;

[0057] FIG. 3 A illustrates initial steps of an example sequence of events of safety-enhanced robotic pharmaceutical dose preparation, according to some examples of the present disclosure;

[0058] FIG. 3B illustrates steps of an example sequence of events of safety-enhanced robotic pharmaceutical dose preparation, according to some examples of the present disclosure;

[0059] FIG. 4 illustrates a flow diagram of an example method of safety-enhanced robotic preparation of a pharmaceutical dose, according to some examples of the present disclosure;

[0060] FIG. 5 illustrates a flow diagram of an example method of safety-enhanced robotic preparation of a pharmaceutical dose, according to some examples of the present disclosure; and FIG. 6 illustrates an example IV bag bearing a label including a bar code, according to some examples of the present disclosure.

[0061] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0062] The present invention, in some embodiments thereof, relates to the field of imaging in robotics and more particularly, but not exclusively, to specification and / or verification of robotic preparation of pharmaceutical doses.

[0063] Overview

[0064] An aspect of some embodiments of the present disclosure relates to safety-enhanced pharmaceutical preparation devices. The pharmaceutical preparation devices are configured to exchange contents among one or more containers to prepare a pharmaceutical dose, and provide the pharmaceutical dose in a receiving container. The exchanges of contents are performed, in some examples, using one or more robotic fluid transfer actuators, operable to manipulate the one or more containers to prepare the pharmaceutical dose and / or transfer the pharmaceutical dose and / or portions thereof among containers.

[0065] Furthermore, in some examples, the pharmaceutical preparation devices include one or more identification devices operable to sense identifier patterns, optionally comprising one or more cameras, RFID sensors, and / or another identification data sensor type.

[0066] A pharmaceutical preparation device, in some examples, comprises one or more elements which act as a container lock. The container lock optionally comprises a dedicated device which locks to prevent manual removal of the receiving container, and / or makes use of other components of the pharmaceutical preparation devices to lock the receiving container against manual removal. In some examples, the container lock comprises a fluid container attachment which the pharmaceutical preparation device also uses as a conduit through which fluids are transferred into and / or out of the receiving container. Optionally, the lock includes a bypass opening mode for use upon need; optionally, operation of the bypass comprises placing a tell-tale up on the receiving container which prevents and / or counterindicates use of its contents.

[0067] In some examples, the pharmaceutical preparation devices include processing circuitry and memory, the memory including instructions which configure the processing circuitry for its operations.

[0068] In some examples, pharmaceutical preparation devices (e.g., their processing circuitry) use the identification device to obtain specification data indicative of specified contents of a pharmaceutical dose. The data optionally include directly indicative information, e.g., specifications of ingredients, amounts, and / or instructions for preparing the pharmaceutical dose. Optionally, the data are indirectly indicative; e.g., the data provide an address, a number selected from a series of numbers, an arbitrarily selected key to a database entry, an identifier at least partially derived from data related to the pharmaceutical dose (e.g., a tracking number comprising one or more fields of information), the output of a hash function, or another type of referencing data.

[0069] In some examples, the pharmaceutical preparation devices, at some time before or during pharmaceutical preparation, use the container lock to lock the receiving container into the pharmaceutical preparation device. Optionally, the locking comprises attachment of the receiving container to a device through which fluid transfer occurs.

[0070] The pharmaceutical preparation devices initiate, using the one or more robotic fluid transfer actuators, a pharmaceutical preparation sequence to prepare the pharmaceutical dose.

[0071] Responsive to completion of the pharmaceutical preparation sequence, a pharmaceutical preparation device, in some examples, operates the one or more identification devices to obtain completed-state identifying data identifying the receiving container containing the prepared pharmaceutical dose. In some examples, the completed-state identifying data are carried and / or displayed by a physical identifying token comprising, e.g., a printed pattern and / or electronic device placed upon the receiving container. For example, a carrier of the completed-state identifying data attached to the receiving container comprises a sticker.

[0072] In some examples, the completed-state identifying data and the specification data are substantially the same and / or identical. For example, a same sticker (or otherwise attached label) used as the specification data indicative of the specified contents of a pharmaceutical dose is then applied to the receiving container to act as the carrier of completed-state identifying data. In some examples, the completed-state identifying data is a copy separate from the carrier of the specification data; e.g., these carriers are two separate copies of the same identifier pattern. In some examples, the completed-state identifying data and the specification data are otherwise related; e.g., linked in a database, sharing one or more portions of their carried data between them, derivable one from the other (e.g., in at least one direction) through a hashing or other algorithm, and / or otherwise interconnected as data. This linkage allows the specified contents for the pharmaceutical dose to be determined (directly and / or indirectly) from the completed-state identifying data. For example, even where the specified contents for the pharmaceutical dose cannot be directly determined from the completed- state identifying data, optionally the specification data indicative of the specified contents of the pharmaceutical dose can be determined. From this, the specified contents are optionally determined. Determination of the indicative specification data optionally comprises transformation of the completed-state identifying data itself, and / or comprises a search; e.g., a search to determine which of a plurality of indicative specification data entries the completed-state identifying data derives from and / or is linked to.

[0073] In some examples, a maintained linkage between the specification data and the completed-state identifying data is omitted and / or deleted, e.g., after suitable information describing the specified contents of the pharmaceutical dose is directly linked to the completed- state identifying data in a data structure stored by a medical records system and / or other data- storing device.

[0074] In some examples, placement of the carrier of the completed-state identification data occurs prior to locking the receiving container into place and / or prior to actual completion of the pharmaceutical preparation. For example, the receiving container is optionally predesignated for its particular use with a label carrying the completed-state identifying data. In some examples, placement is performed while the receiving container is locked in place; e.g., placement by a device operator (e.g., by placing a sticker upon the receiving container), and / or automatic.

[0075] Upon determining that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose, the pharmaceutical preparation devices unlock the container lock, in accordance with the determination.

[0076] Use of identification-dependent unlocking provides potential advantages for assuring that, e.g., mislabeled and / or partially prepared pharmaceutical doses are not mistaken for correctly formulated dosages, and misused accordingly.

[0077] Before explaining at least one embodiment of the present disclosure in detail, it is to be understood that the present disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or given in the Examples, drawings. Features described in the current disclosure, including features of the invention, are capable of other embodiments or of being practiced or carried out in various ways. Pharmaceutical Preparation Devices and Systems

[0078] Pharmaceutical Preparation Device

[0079] Reference is now made to Fig. 7, which illustrates an example robotic pharmaceutical preparation device 210, according to some examples of the present disclosure.

[0080] In some examples, syringe-manipulation subsystem 120 comprises a subsystem that manipulates a syringe; for example, by gripping / releasing a syringe 156 (e.g., syringe barrel 155) using gripper 105, by drawing a fluid from fluid container 175 into syringe barrel 155, and / or by injecting a fluid from syringe barrel 155 into fluid container 175. Herein, fluid container 175 is also referred to as a “receiving container”.

[0081] Syringe-manipulation subsystem 120 comprises a portion of robotic fluid transfer manipulator 121. In some examples, fluid transfer manipulator 121 comprises container transport 171. Collectively, actuated capabilities of fluid transfer manipulator 121 move containers among locations and / or induce movements of fluid resulting in transfer between containers (e.g., containers coupled, for example through one or more fluid exchange connectors 165). These capabilities are also referred to herein as “robotic capabilities” and / or “robotic fluid transfer actuators”; e.g., actuators, through the movements of which fluid is transferred while contained and / or exchanged between containers. Optionally, fluid transfer involves more than one interconnection overall; for example, a syringe 156 is optionally used to transfer fluid into and / out of one or more vials and / or IV bags containing pharmaceutical substances before eventually transferring fluid into a receiving container (e.g., another vial and / or IV bag) which is the container that carries (contains) the prepared dose for delivery to the next recipient.

[0082] Actuator components of fluid transfer manipulator 121 include, for example, electrical motors, belts, gearing, casings, position sensors, bearings, and / or support members. Operations performed by pharmaceutical preparation device 210 using fluid transfer manipulator 121 during pharmaceutical dose preparation are also referred to herein as a “sequence”, e.g., a sequence of operations which mix materials among a plurality of containers to produce (e.g., prepare by mixing, dissolving, stirring, transferring, and / or otherwise manipulating container contents) a pharmaceutical preparation, also referred to herein as a “dose”. It should be understood that the pharmaceutical preparation is not necessarily a single-dose preparation.

[0083] Optionally, syringe tip 185 inserts into fluid exchange connector 165, which in turn is attached to fluid container 175. Optionally, syringe plunger 145 inserts into syringe barrel 155. In some examples, a container lock 180 is provided, which system controller 110 operates to control release of fluid container 175 from pharmaceutical preparation device 210. Optionally locking functions are performed by one of the fluid exchange connectors 165, and / or another component. For example, a component of container transport container transport 171 such as a robotic arm which maneuvers fluid container 175 into position optionally grips, covers, blocks movement of, or otherwise interferes with release of fluid container 175 from pharmaceutical preparation device 210 until system controller 110 is ready to release fluid container 175. Insofar as a syringe connector 165 and / or another component has a dual use for locking, it also should be understood as a component of container a lock 180, and / or as container lock 180 itself.

[0084] Herein, container lock 180 is said to “lock” a fluid container 175 into pharmaceutical preparation device 210 at least insofar as the ordinary sequence of physical operations to remove fluid container 175 from its position after preparation of a pharmaceutical preparation it contains is prevented and / or interrupted. Interruption optionally is characterized by the introduction of one or more steps which involve overcoming one or more interfering elements not normally interfering and / or not normally as difficult to remove from interfering locations.

[0085] Herein, overcoming the interfering elements outside of a normal unlocking condition (for examples that optionally support such overcoming as an intentional feature of the device) is referred to as “bypassing” the container lock 180. Bypassing container lock 180 optionally entails, e.g., use of an unusual tool, access to an unusual and / or difficult reach port and / or mechanism, application of force usually not required, and / or entry to a user interface mode accompanied by a prominent indication that the container lock 180 is being bypassed.

[0086] In some examples, bypassing container lock 180 results in an associated invalidation of the prepared (or partially prepared) pharmaceutical preparation, at least insofar as processes of a pharmaceutical preparation system 200 of which pharmaceutical preparation device 210 is a part and / or processes associated with the originally designated use of the pharmaceutical preparation are concerned. Optionally, this comprises a data indication (e.g., an invalidation flag) associated with records of the pharmaceutical preparation. Optionally, bypassing the container lock 180 produces a tell-tale indication on the fluid container 175, e.g., a stain, color mark, damage, and / or another physical indication. In some examples, the lock bypassing procedure comprises the operator making or applying such a mark; e.g., applying a designated color, rejection label, or other visual indication to fluid container 175 so that it will be recognized as not for use or otherwise invalid. In some examples, the tell-tale comprises removal of the contents of fluid container 175. In some examples, a sensor such as camera 140 images the bypass tell-tale, and lock bypassing is completed when system controller 110 recognizes the tell-tale object and / or conditions and releases container lock 180 accordingly.

[0087] Syringe-manipulation subsystem 120, in some embodiments, includes plunger arm controller 170, which can physically control a mechanical plunger arm 135 to withdraw syringe plunger 145 from syringe barrel 155, thereby drawing fluid from fluid container 175 into syringe barrel 155. Similarly, plunger arm controller 170 can physically control mechanical plunger arm 135 to push syringe plunger 145 into syringe barrel 155, thereby expelling into fluid container 175 from syringe barrel 155.

[0088] Fluid container 175 optionally comprises, e.g., a vial or bag of fluid. In some examples of the present disclosure, a label 80 is provided for use with fluid container 175. Upon label 80, an identifier pattern 85 is provided (e.g., displayed as part of the printing upon the label 80). Label 80 is an example, more generally, of a “carrier” of identifier pattern 85 (and correspondingly an example of a carrier of data represented by the identifier pattern).

[0089] Optionally, the identifier pattern 85 is connected with fluid container 175 only at the end of preparation operations (e.g., attached as a sticker). The identifier pattern comprises, for example, a bar code, QR code, and / or text, to be used as an identifier. In some examples, label 80 is maintained separate from fluid container 175 until a certain stage of pharmaceutical preparation is reached, e.g, completion of mixing operations. In some examples, label 80 and its associated identifier pattern 85 (and identifier) are pre-associated with an intended pharmaceutical preparation. In any of these cases, an identifier pattern 85 associated specifically with a receiving container is also referred to herein as conveying “completed-state identifying data”.

[0090] It is noted that in cases for which a carrier of the completed-state identifying data is attached to the receiving container before the completed state of pharmaceutical preparation is actually reached, confusion is optionally prevented by having pharmaceutical preparation device 210 and / or a system with which it communicates wait for completion of operations before actually recording the identifying data with the character of “completed-state” identifying data in particular.

[0091] Syringe-manipulation subsystem 120 optionally includes gripper controller 160, which can physically control gripper 105 to grip or release syringe barrel 155

[0092] In some examples, system controller 110 comprises a separate controller including a processing circuitry 115 and memory 125. Optionally, system controller 110 is operably connected to syringe-manipulation subsystem 120 (for example: via a bus or a network). In some embodiments, system controller 110 can command syringe-manipulation subsystem 120 to, for example, draw and / or expel a specified quantity (e.g., volume) of a fluid (such as a medication to be injected into a patient) into / out of syringe barrel 155.

[0093] In some examples, one or more cameras 140 (any one or more of which optionally also act as identification device 107) comprises a digital camera configured to optically monitor, e.g., components of the pharmaceutical preparation system 210 and / or operations conducted by syringe-manipulation system 120. Optionally, one or more cameras 140 are positioned so that they capture a digital images of, e.g., syringe components and / or other container contents from respective particular distances (optionally a range of distances selectable, e.g., by focusing adjustments and / or movement of one or both of camera 140 and / or syringe barrel 155 and / or fluid container 175); herein referred to as camera distance 195. Also associated with camera 140 is a field of view 141, oriented to and / or adjustable to orient to include at least portions of syringe barrel 155 and / or fluid container 175. Optionally, this is used to allowing imaging of label 80 and / or identifier pattern 85 (e.g., once placed on fluid container 175). In some embodiments, camera 140 is located in a fixed position relative to, e.g., syringe barrel 155. In some embodiments, camera 140 can be manually or automatically moved to different positions or distances relative to, e.g., syringe barrel 155.

[0094] Optionally, camera controller 130 is operably connected to camera 140. Camera controller can implement camera control methods, and can supply digital images to system controller 170. Optionally, system controller 170 is operably connected to camera controller 130

[0095] In some examples, an identification device 107 additional and / or alternative to camera 140 is provided, configured for sensing of identifier patterns from an identifier token (e.g., comprising an optically and / or radio frequency operating scanning device), e.g., as described herein. In some examples, camera 140 itself performs the role of identification device 107, optionally along with other roles camera 140 performs. Additionally or alternatively, identification device 107 comprises and / or is provided together with a printer, e.g., a label printer.

[0096] System-Level Control of Pharmaceutical Preparation

[0097] Components and Communications

[0098] Reference is now made to Fig. 2, which illustrates an example of a safety-enhanced pharmaceutical preparation device deployed in communication with a control server 220 and / or medical records system 230, according to some examples of the present disclosure. Together, medical records system 230, one or more control servers 220, and one or more pharmaceutical preparation devices 210 comprise a distributed pharmaceutical preparation system 200.

[0099] In some examples, electronic medical records system 230 comprises a computer system including processing circuitry 215A and memory 225A. Electronic medical records system 230 optionally includes a patient record database 255, comprising data pertaining to prescriptions of individual patients. In some examples, records in patient record database 255 furthermore maintain records of prescriptions prepared for administration, e.g., that they are to be prepared, that they have been prepared, and in particular — evidence that preparation that occurs is according to specified instructions (e.g., according to a specified prescription).

[0100] In some examples, control server 220 comprises a computer system including processing circuitry 215B and memory 225B. Optionally, control server 220 is operably connected to electronic medical records system 230 and pharmaceutical preparation device 210 (e.g., via respective communication links). Control server 220 is configured perform functions prior to and / or during the preparation of pharmaceutical doses; e.g., as described in relation to Figs. 3A-5.

[0101] In some examples, pharmaceutical preparation device 210 includes hardware and controller components, e.g., as described above in relation to Fig. 1. Optionally, pharmaceutical preparation device 210 itself includes processing circuitry 215C and / or memory 225C. In some examples, processing circuitry 215C and memory 225C comprise functional modules of user interface 260, identification device 107 (noting again that this is optionally provided as one or more cameras 140), and / or hardware control unit 245C.

[0102] In some embodiments of the present disclosure, a human operator is directly involved in one or more phases of operation. Optionally, human presence and / or involvement is required by regulation and / or according to risk management procedures associated with operation of pharmaceutical preparation device 210 and / or pharmaceutical preparation system 200. Human- reliant procedure operations such as one or more user confirmations, user-initiated commands, identifier sensing, and / or identifier attachment ( / .< ., attachment of a carrier of completed-state identifying data) are optionally used to ensure, demonstrate, and / or document that a suitable (e.g., regulation- and / or approved-procedure-compliant) level of human attention is engaged with the processes of pharmaceutical preparation, even though many aspects of this process are otherwise automated.

[0103] It is noted in this regard that human capabilities and machine capabilities are potentially complimentary in their relative strengths, e.g., humans for their breadth of judgement, and machines for their reproducible behavior. Although often excellent at performing repetitive tasks with accuracy and precision, a general risk with machine-implemented operations is a potential failure to note and / or react to exceptions occurring outside of defined parameters. Furthermore, it is a potential advantage to free human operators from narrower responsibilities (e.g., of measuring and / or transferring materials as such) in order to gain more from human capacities of judgement and awareness. In some examples of the present disclosure, human activity is interlaced with machine activity by involving both in documentation practises related to pharmaceutical preparation.

[0104] Pull / Push Job Assignment

[0105] In some examples, the overall process of pharmaceutical preparation is managed according to a pull / push model, wherein pharmaceutical preparation device 210 and / or its operator signal readiness of the machine by “pulling” the next preparation job from medical records system 230 via control server 220 (optionally with or without having advance information about what that job will be). Control server 220, after communicating with medical records system 230, responds with a “push” describing the job.

[0106] The job is at first described at least insofar as pharmaceutical preparation device 210 and / or its operator require to complete a next stage of operations under their responsibility, but optionally not described completely enough to fully finish the job without further communications. Accordingly, in some examples, there are one or more additional push / pull stages as various phases of the operations to prepare the pharmaceutical preparation begin and / or complete. As part of these communications, one or more identifiers are shared which become part of the records associated with the job, the patient, and / or the pharmaceutical preparation itself.

[0107] In some examples, the “pulling” side of the job (where pharmaceutical preparation actually happens) optionally begins unaware of job parameter specifics.

[0108] Optionally, however, there is at least some knowledge of job parameters connected. In one example of this: there may be certain preparation materials available to a certain pharmaceutical preparation device 210 (and yet potentially not all preparation materials used within the system overall) which make it suited (or not) for certain jobs known to control server 220 and / or medical records system 230. Optionally, initial communications from pharmaceutical preparation device 210 serve to indicate a state of capabilities to control server 220.

[0109] Optionally, at least some aspects of this capability indication are provided using an “identifier”, or more particularly an identifier also referred to herein as an “initial” or “original” identifier. This identifier is also, and more particularly, referred to herein interchangeably as a “specification identifier”, and as “specification data indicative of specified contents” of the pharmaceutical preparation. The identifier is optionally provided through use of a token of no particular initial significance, which is assigned significance in communication and / or documentation through operations of pharmaceutical preparation system 200. Optionally, the specification identifier does have a certain amount of initial significance (e.g., it is optionally pre-associated with preparation of a certain prescription, prescription type, requirement, and / or capability), and gains further significance through communications and / or record keeping activities associated with pharmaceutical preparation.

[0110] Specification Identifier Significance

[0111] In some examples, the specification identifier itself is “only a binder” between a physically labeled pharmaceutical preparation and its data representation in the pharmaceutical preparation system 200 — optionally unique as such, but otherwise not previously associated with any meaningful information. For example, the specification identifier is optionally selected (e.g., as a “next in line” number and / or from a stack of labels) and / or assigned arbitrarily and / or randomly (e.g., algorithmically) in the period of time just before and / or after communications begin between pharmaceutical preparation device 210 and control server 220.

[0112] Alternatively, to one or more of the participants in pharmaceutical preparation system 200, this identifier is itself indicative of partial to full details associated with the pharmaceutical preparation. The particular identifier may have been pre-assigned to identify, e.g., a preparation site, an eventual delivery site, a set of preparation capabilities, a set of preparation materials at hand 210, and / or another status and / or requirement. Optionally, the identifier is already associated with a particular prescription and / or patient.

[0113] In some examples, the identifier is furthermore associated with a physical carrier; e.g., a printed label, RFID device, or other item, and provided as a “scannable identifier”, that is, an object which can be subjected to at least automated sensing (inspected) to determine the value of the identifier itself. In some examples, the identifier comprises one or more visual indications, optionally visual indications readably by a human, e.g., including alphanumeric characters.

[0114] In some examples, a scannable identifier is associated with a kit of preparation materials, e.g., included in their packaging. Optionally, the kit of preparation materials is assembled generically (separately from knowledge of a particular patient’s prescription), in advance of a particular pharmaceutical preparation, and assigned a full or partial identifier on that basis. Optionally, the kit is predesignated for preparation of a particular prescription ( / .< ., of a particular patient). Optionally, the scannable identifier is provided standalone.

[0115] When operation of a pharmaceutical preparation device 210 senses (e.g., scans) and communicates data from a label 80 or other article bearing a given identifier pattern 85 carrying a specification identifier, it optionally signifies to a control server 220 and / or medical records system 230 that a particular pharmaceutical preparation device 210 is ready to work with a certain set of materials, optionally at least partially generic, and / or optionally associated with a particular prescription. In some examples (e.g., for the case of carriers which at least begin as standalone carriers of scannable identifiers), there is simply a direct association of identifier and prescription, with capabilities left as a separate consideration (e.g., assumed sufficient, in some examples).

[0116] Despite potentially some level of specific pre-designation of an identifier to a prescription and / or its requirements, additional needed information is optionally unavailable to the pharmaceutical preparation device 210 initially: e.g., it may not know exact quantities of materials to use. Potentially, it possesses no particular information about the pre-designation. In other words, the full character of the identifier as a “specification” identifier is optionally at first inaccessible to pharmaceutical preparation device 210.

[0117] Additionally or alternatively (and conversely), the records and control system comprising control server 220 and / or medical records system 230 may be unaware of (that is, not include a precise and / or updated record of) the exact disposition of materials already or about to be associated with a prescription until the moment that a pharmaceutical preparation device 210 signals its availability to mix materials suitable and / or designated for the prescription.

[0118] Moreover, information available to one side is not necessarily available to the other. For example, a facility operating pharmaceutical preparation devices 210 may choose to assign identifiers according to a scheme designated for its own internal purposes which control server 220 makes no reference to. Conversely, a facility operating pharmaceutical preparation devices 210 may have assigned to it from outside a set of identifiers having meaning associated with data stored by control server 220 and / or medical records system 230, but not itself be able to determine this meaning from the identifiers as such. Optionally, the final version of a specification identifier associated with a pharmaceutical preparation is assembled from a plurality of individual identifiers, optionally first generated, assigned, and / or having meaningful significance to a respective one or more of a plurality of agents involved in the overall logistics of pharmaceutical preparation. Scan-Gated Pharmaceutical Preparation

[0119] Reference is now made to Fig. 3A, which illustrates initial steps of an example sequence of events of safety-enhanced robotic pharmaceutical dose preparation, according to some examples of the present disclosure.

[0120] It should be understood that examples provided herein in the form of flowcharts indicate one or more orderings of their operations as examples and / or as indications of conceptual order. Orderings indicated are not limiting of the order of operations in other examples to which the flowcharts pertain. For example, operations optionally occur in different orders and / or at least partially concurrently, e.g., in cases where neither operation is strictly dependent on an output of the other in order to begin. Operations, in some instances, are optional, and / or susceptible to alternative implementation; for example as discussed in descriptions associated with the figures.

[0121] Communications-Gated States of Pharmaceutical Preparation

[0122] The operations of Fig. 3A provide an example in which a specification identifier of a pharmaceutical preparation is integrally connected to the onset of the process of mixing it. This process next optionally leads (e.g., as described in relation to Fig. 3B) to physical association of a completed-state identifier (e.g., a sticker) to the pharmaceutical preparation.

[0123] In principle, properties of being a system-unique identifier and of being physically associated with a particular pharmaceutical preparation could be assigned at any stage; e.g., at any time beforehand by labeling an empty fluid container 175 designated for storage of a particular pharmaceutical preparation and including it with a kit of materials designated for use in creating that preparation.

[0124] In some examples of the present disclosure, an eventual completed-state identifier is at least pre-allocated, e.g., by medical records system 230, and optionally sent (e.g., as a physical label or other carrier) to the physical site of the pharmaceutical preparation device 210 which mixes the pharmaceutical preparation ahead of time. Alternatively, a pre-allocated and / or on- demand generated completed-state identifier is printed out or otherwise incorporated into a label or other carrier at the physical site of the pharmaceutical preparation device 210 which mixes the pharmaceutical preparation. However, even in such cases, there are potential advantages to tracking effectiveness and / or system security by delaying full recognition of the completed-state identifier as representing a finished pharmaceutical preparation until certain conditions are met through use of procedure. Descriptions in relation to Fig. 3A deal with establishing early conditions for some examples of the present disclosure; descriptions in relation to Fig. 3B deal with establishing later conditions. Descriptions in relation to Figs 4 provide another example of dose preparation verification and / or security, e.g., in accordance with the descriptions of Figs. 3A-3B. The example of Fig. 5 omits ( / .<?., makes optional) aspects related to centralized and / or server communication, e.g., optionally confining operations to the local device throughout most or all of the method.

[0125] The method of Fig. 3 A comprises a temporally defined (that is, “happening during a definite time”) digital handshake involving each of pharmaceutical preparation device 210, control server 220, and medical records system 230. This digital handshake helps define a system-wide state of preparation. Before this digital handshake occurs, control server 220 can “know”, e.g., by consulting medical records system 230, that the pharmaceutical preparation in question has not been prepared by operations of pharmaceutical preparation system 200, even if some or all of the materials involved in its preparation have been shipped and disseminated, with their exact current status potentially unknown. This provides potential advantages in flexibility for assigning and / or re-assigning resources (e.g., dispatching jobs among devices, device operators, and / or materials), along with potentially increased certainty that effort will not be duplicated, interrupted, and / or unduly delayed.

[0126] The digital handshake is also a potentially reliable and low-maintenance indicator. First, there is no need to update it until pharmaceutical preparation operations begin. Second, at least in some examples of the operations of Fig. 3A, the digital handshake will not be skipped over, or somehow missed by any of the main components of the system. Without the digital handshake occurring, the operator of pharmaceutical preparation device 210 does not have the information needed to prepare the pharmaceutical preparation. And in providing that information, both control server 220 and medical records system 230 are directly involved, and so also notified in consequence that preparation has begun.

[0127] Scanning Operations

[0128] At block 305, in some examples, operations begin with an operator positioning an identifier pattern to be read by an identification device 107. In some examples, the identifier pattern is optically scannable; optionally comprising a printed label or sticker. The identifier pattern comprises, for example, a bar code, QR code, and / or text. The identifier pattern bar code, QR code, text, and / or other signal type / data representation is set to be and / or become indicative of an identifier of a prescription stored in an electronic medical records (EMR) system. Identifier patterns (i.e., signals and / or physical configurations of matter from which identifiers are determined), and identifiers themselves e.g., data determined from one or more identifier patterns) may be understood herein as comprising “data indicative of the specified content” for a pharmaceutical preparation. In some examples, the function of being so- indicative is optionally full and / or partially pre-established. In some examples, the function of being so-indicative is at least partially established as part of one or more communication operations; e.g., a random number is optionally provided to pharmaceutical preparation device 210 and associated with further instructions obtained from a control server 220, while control server 220 and / or medical records system 230 record further connections of the association, e.g., to potentially identifying patient data, while pharmaceutical preparation device 210 does not, and has no access to these, either.

[0129] As used herein, the term “scannable” refers to the pattern being determinable (readable) by automated sensing (inspection), i.e., not to the use of a scanning motion as such. It is not excluded that reading of a pattern is implemented non-optically; e.g., using a radio frequency device such as an RFID chip. In that case, the pattern being scanned comprises, e.g., a temporal pattern of radio signals, e.g., bits in a transient signal, produced by a device configured to produce such a signal. However, optical pattern types have potential advantages for low cost, ready generation, and / or ready availability of readers.

[0130] In some examples, the operator issues an instruction through user interface 260 that scanning should begin, e.g., by pressing a “SCAN” button on a touchscreen interface of a pharmaceutical preparation device, or otherwise initiating operations.

[0131] At block 310, in some examples: in response to the operator’s command, the pharmaceutical preparation device 210 optionally signals to a control server that the pharmaceutical preparation device identification device is ready to be activated. In response, at block 315, control server 220 signals the pharmaceutical preparation system 210 to control the identification device 107 to perform the scanning of the label (or sticker etc.).

[0132] Blocks 310-315 represent an optional “pre-handshake” phase of operations, e.g., establishing that communications are appropriately established, and allowing pharmaceutical preparation device 210 and control server 220 to mutually identify and / or authenticate themselves appropriately. In an alternative implementation, the scan is simply transmitted at block 320, e.g., as a result of the operations of block 320. In some examples, it is the initial scan of block 320 which is omitted, e.g., because the identifier itself is instead provided to pharmaceutical preparation device 210 by control server 220 upon authentication; e.g., provided in a digital form which is printed out using a printer associated with identification device 107 at pharmaceutical preparation device 210. It should be noted that the printing approach and the scanning approach are similar at least insofar as they both involve a physical token. Operations described, e.g., in relation to Fig. 3B associate this physical token directly with the prepared pharmaceutical preparation.

[0133] Optionally, control server 220 relays to pharmaceutical preparation device 210 at least some of any remaining information relevant to preparation of a particular pharmaceutical preparation at this stage of operations, e.g., enough to allow selection of what is going to be worked on to be performed at least in part locally and at the level of the pharmaceutical preparation device 210. For example, control server 220 optionally offers pharmaceutical preparation device 210 a plurality of job options, which pharmaceutical preparation device 210 and / or its operator optionally select from according to resources (e.g., time and / or materials) available at the local worksite.

[0134] In principle, control server 220 could send all remaining information needed to generate a particular pharmaceutical preparation (and optionally information for any of several such preparations available to work on to select among). This is not necessarily excluded. However, there are potential advantages in holding back at least some information initially; e.g, as a demonstrable procedure maintaining global status certainty within the system overall.

[0135] At block 320, in some examples, identification device 107 optionally scans label 80. It is again noted that at this stage, label 80 is not necessarily itself associated either physically or through data with the particulars of the operation about to be performed. For example, it can be printed out simply as the next identifier number in a sequence. Alternatively, the identifier provided upon label 80 is pre-associated with a given patient and / or prescription, and acts as a retrieval identifier for that particular patient and / or prescription.

[0136] As already mentioned, the flow of data is optionally in the opposite direction, with control server 220 and / or medical records system 230 providing the identifier to be used, e.g., in a printable file format. In that case, suitable communication and / or synchronization of state optionally occurs to establish that pharmaceutical preparation device 210 can indeed perform a certain pharmaceutical preparation task, e.g., that suitable consumables are available for it.

[0137] Where optical scanning is used, pharmaceutical preparation device 210 optionally itself performs image processing on the scanned image to derive and / or confirm an identifier of a prescription dose (e.g., an identifier associated with identifier pattern 85). It is a potential advantage for pharmaceutical preparation device 210 to perform this processing at least for itself; this helps ensure that the identifier is known to pharmaceutical preparation device 210 through a direct and local chain of operations linking use of camera 140 to calculation of the identifier. Optionally, however, some or all of the processing to determine the identifier is performed on control server 220.

[0138] Optionally, the identifier comprises a number, text string, or other stream of data which uniquely and uniformly identifies the fluid container 175 as such (e.g., in case the identifier has been pre-assigned in this manner), identifies the intended contents of the completed pharmaceutical preparation, and / or identifies and / or is associated with a patient, facility, and / or device operator. Optionally, the identifier incorporates one or more aspects of the identifier pattern 85 which are not assigned a direct textual and / or numeric equivalent, e.g., identifier aspects derived from the relative spacings sizes, and / or colors of marking elements on label 80.

[0139] Completing block 320, the pharmaceutical preparation device 210, in some examples, transmits the prescription dose identifier to the control server 220.

[0140] At block 325, in some examples: after the control server 220 receives the prescription dose identifier (and / or other selection and / or capability information from pharmaceutical preparation device 210), control server 220 requests prescription data from electronic medical records system 230.

[0141] Optionally, the request of block 325 is performed concurrently with and / or following other operations (for example, those described above). The request is optionally sufficiently specified by the identifier itself. Optionally, the request uses additional information identifying a patient, defining local capabilities for pharmaceutical preparation, and / or other relevant information narrowing options for the present preparation enough that medical records system 230 can determine to grant access to a relevant one or more records.

[0142] In some examples, control server 220 stores cached data, and communications with medical records system 230 are used to validate the cache, obtain a decryption key granting access to the cache, and / or otherwise complete the information requested.

[0143] At block 330, in some examples, electronic medical records system 230 returns the prescription data (and / or other requisite information) to the control server 220.

[0144] Optionally, access granted by medical records system 230 is contingent upon receiving a particular identifier specific to a given pharmaceutical preparation. Optionally, access is granted in more general cases; e.g., when the identifier is at least in part generic in meaning (e.g., indicating ingredients but not a particular prescription ). In such cases, medical records system 230 optionally selects a prescription to assign to the identifier.

[0145] Optionally (i.e., when the identifier in question is not uniquely preassigned to a specific prescription already), there is a process of negotiation wherein information about present capabilities (of the pharmaceutical preparation device 210) and / or present prescription requirements (held by the medical records system 230) are exchanged until a suitable candidate pharmaceutical preparation is selected to mutual agreement.

[0146] At least by this stage, it should be noted, the identifier being discussed possesses the particular characteristic of being a “specification identifier”, indicative of the specified contents of a pharmaceutical dose. This characteristic may have been fully associated with it from the outset of the method, or it may have been fully or partially acquired (within the context of pharmaceutical preparation system 200 overall).

[0147] The prescription data includes, for example, the name of the prescription and the dosage, and / or other information suitable for presentation on a user interface. In some examples, the prescription data specify a list of materials (e.g., fluid containers, syringes, ingredient components of the pharmaceutical compound, etc.) which an operator pharmaceutical preparation device 210 is instructed to place in appropriate positions of the pharmaceutical preparation device pharmaceutical preparation device 210 in advance of robotic dose preparation.

[0148] At block 331, in some examples, the user interface 260 of the pharmaceutical preparation device 210 optionally performs basic validations of the received prescription data (e.g., ensuring that dose amount is non-zero, and otherwise within reasonable constraints of quantity and / or safety). If verification that local capabilities are suited to the particular prescription has not yet been performed, this is optionally performed at the time of block 331.

[0149] At block 340, in some examples, the new prescription data is optionally made available to the operator; again, e.g., by displaying it on user interface 260.

[0150] Reference is now made to Fig. 3B, which illustrates steps of an example sequence of events of safety-enhanced robotic pharmaceutical dose preparation, according to some examples of the present disclosure.

[0151] The operations of Fig. 3B, in some examples, complete the change in status of a prescription from “unprepared” to “prepared”. Again, operations comprise a digital handshake operation, dependent on pharmaceutical preparation device 210 to initiate. However, control server 220 and medical records system 230 are on notice from the operations of Fig. 3A, and so will be aware of an exception in case something prevents pharmaceutical preparation device 210 from completing its roles in operations successfully.

[0152] At block 341, in some examples, an operator of pharmaceutical preparation device 210 selects a prescription for preparation from a user interface 260 (optionally, more than one such prescription was provided, e.g., as a result of the operations of Fig. 3A). The user interface 260 then optionally displays for the operator the specified materials for placing in the pharmaceutical preparation device (e.g., fluid containers of specific medicaments, syringe, IV bag, etc.). The operator places these in the pharmaceutical preparation device 210. The pharmaceutical preparation device 210 optionally performs validations of the presence of any one or more of these components; e.g., ensuring that fluid containers 175 are present, that labels on fluid containers (apart from label 80 itself) are correct, and / or that syringe 156 is present.

[0153] In response to successful validation at this stage, pharmaceutical preparation device 210 optionally presents an indication on user interface 260, for example by making a “START” button available on a touchscreen interface display. In response, the operator operates user interface 260 to indicate that robotic preparation should begin (for example: by pressing a “START” button on a touchscreen interface of a pharmaceutical preparation device). Optionally, verification of setup itself is sufficient to automatically start pharmaceutical preparation. In such a case, the operator in effect initiates robotic preparation by placement of the last specified element. However, use of a particular user command provides a potential advantage by providing a specific checkpoint for which human consideration of an overall configuration is encouraged.

[0154] Optionally, pharmaceutical preparation device 210 is configured, at least by default, to perform the preparation without further human operator inputs. At this stage, one or more of the physical parameters affecting the preparation (e.g., all of the pharmaceutical material inputs from which the preparation is to be prepared) may be considered “frozen” and unchanging for the rest of preparation to follow. Optionally, pharmaceutical preparation device 210 continues to monitor components set up by the operation (e.g., by continued imaging), confirming that they are not swapped or otherwise disturbed during following operations to prepare the designated pharmaceutical preparation. Should human intervention occur during operations (e.g., to correct a fault and / or resupply a one of the pharmaceutical components), pharmaceutical preparation device 210 optionally repeats any suitable portion of the identifier exchanges and / or verifications of Figs. 3A-5, with authorizations and / or records of this granted and / or stored as appropriate by control server 220 and / or medical records system 230.

[0155] At block 342, in some examples, pharmaceutical preparation device 210 transmits to the control server 220 an indication of the “new order” to prepare a pharmaceutical dose associated with the dose specification identifier previously determined, e.g., from identifier pattern 85 of label 80 and / or otherwise in the course of the operations of Fig. 3A. Optionally, the dose-specific specification identifier (e.g., that scanned in Fig. 3A) is itself used as or otherwise associated to an “order number”, and eventually as the “completed-state identifier”. Optionally, the completed-state identifier and specification identifier comprise different data. Alternatively, e.g., in examples in which a sticker is first scanned (as a specification identifier), then attached to a receiving container (as a completed-state identifier), the two identifiers are the same.

[0156] At block 343, in some examples, control server 220 determines job parameters of the prescription. Job parameters can include specific attributes of the prescription preparation and / or the process of its preparation not necessarily available from data of the original prescription, e.g., as shared in the operations of Fig. 3A, and / or as first written. For example, job parameters can include an amount of fluid to draw from a fluid container that should be subsequently injected into an IV bag. In some embodiments, the job parameters can include additional data such as specific preparation steps to be taken by the pharmaceutical preparation device (e.g., validation of syringe volume), specific parameters to be utilized (e.g., syringe draw speed etc. As a non-limiting example, control server 220 determines the job parameters from a local database.

[0157] At block 344, in some examples, control server 220 transmits the job parameters to the pharmaceutical preparation device 210. It is not excluded that control server 220 has transmitted some or all of the requisite information previously (e.g., during operations of Fig. 3A, and / or during previous pharmaceutical preparation sessions), with the data of block 344 being provided as a confirmation, decryption key, cache pointer, or other “completion” of the data transaction.

[0158] In some examples, the operations of block 343 and / or block 344 are gated (allowed to happen or not) based on additional information, e.g., images and / or other reiterations in messages sent from pharmaceutical preparation device 210 asserting and / or confirming that materials and pharmaceutical preparation device 210 itself are in a condition suitable to begin pharmaceutical preparation.

[0159] Again, it is not excluded that pharmaceutical preparation device 210 optionally receives whatever information it needs ahead of time (e.g., at or before the time of the operations of Fig. 3A), with the operations of blocks 342-344 being largely confined to an exchange of messages between pharmaceutical preparation device 210 and control server 220 indicating that pharmaceutical preparation can and then has begun.

[0160] However, it is a potential advantage for pharmaceutical preparation information available to pharmaceutical preparation device 210 to remain at least partially incomplete, inaccessible, and / or unusable up until control server 220 “gates” the beginning of preparation operations themselves by providing this information to pharmaceutical preparation device 210. For example, this helps provide an inherent assurance that use of materials is recorded, and that use of materials occurs when and how determinative records eventually stored in medical records system 230 will indicate.

[0161] In this regard, it can be asserted, in effect, that under ordinary circumstances preparation “could not have begun” until the time at which control server 220 itself provided the final information needed to prepare a pharmaceutical preparation Such an assertion is potentially useful in demonstrating suitable control of processes, e.g., for regulatory and / or quality assurance purposes. The validity of the assertion is optionally strengthened by other methods, e.g., facility monitoring controls. Furthermore, if the normal operation of pharmaceutical preparation device 210 relies on data that has been freshly sent from control server 220, there is potentially a correspondingly greater confidence and / or more robust documentation trail showing that the correct preparation instructions are applied actually to the materials queued in pharmaceutical preparation device 210 for use.

[0162] Control server 220 optionally is provided with capabilities for validation and / or verification which are beyond capabilities of pharmaceutical preparation device 210 itself, and / or centralizes those capabilities. Centralization of such capabilities in control server 220 potentially simplifies security and / or updating of procedures. For example, pharmaceutical preparation device 210 optionally sends data to control server 220 in the form of images, time stamps, and / or sensor data. Control server 220 optionally performs any suitable additional checks, which may be automatic, and / or involve remote human supervision.

[0163] At block 345, in some examples, pharmaceutical preparation device 210 performs the robotic pharmaceutical preparation steps based on the received job parameters. In some examples, however, the finished pharmaceutical preparation remains locked into pharmaceutical preparation device 210 at this stage (e.g., locked by container lock 180 and / or another mechanism provided with pharmaceutical preparation device 210).

[0164] At block 350, in some examples, e.g., after successful completion of the robotic pharmaceutical preparation steps, the operator and / or pharmaceutical preparation device 210 itself physically associates the completed- state identifier exchanged and / or agreed upon with the rest of pharmaceutical preparation system 200 (e.g., the one scanned and / or printed in the operations of Fig. 3A) with the prepared dose.

[0165] For example, the operator and / or pharmaceutical preparation device 210 place a label and / or sticker on a prepared syringe, IV bag and / or vial. As also described above, a potential advantage of involving a human operator in the labeling procedure is the resulting assurance that a there is a “human in the loop”. For example, human operator placement of a label demonstrates that there individual physically present and engaged with the process of formulating the pharmaceutical preparation. This individual is, moreover, positioned to be aware of the overall condition of pharmaceutical preparation device 210 and / or the facility within which it operates. This has potential benefits for risk management and / or for satisfying regulatory concerns.

[0166] In some example, the operator operates user interface 260 to indicate that robotic preparation has completed (for example: by pressing a “FINISH” button on a touchscreen interface of the pharmaceutical preparation device 210).

[0167] At block 355, in some examples, the pharmaceutical preparation device 210 signals to the control server 220 that dose preparation is complete. At block 360, in some examples, the control server then signals the pharmaceutical preparation device to capture an image of the prepared dose, or otherwise read the completed- state identifier that has been affixed thereto.

[0168] In the case of an optical reader, the pharmaceutical preparation device 210 can then capture an image of the dose (e.g., using camera 140). Optionally pharmaceutical preparation device 210 performs image processing on the captured image to determine the completed-state identifier of the prescription dose. Additionally or alternatively, this task is performed by control server 220. Optically, another form of dose / identifier association evidence is generated. For example, an RFID tag is optionally read using a reading positioned in suitable physical proximity to the prepared dose; proximity itself is optionally ensured by physical constraints, imaged, and / or otherwise confirmed.

[0169] At block 365, in some examples, and assuming the completed-state identifier now read suitably matches the identifier expected (e.g., the one originally scanned and / or printed, and / or an otherwise-defined completed-state identifier), then the pharmaceutical preparation device performs an unlocking operation to allow the dose to be removed from the pharmaceutical preparation device. The status of “expected” should be understood to comprise a suitable connection of the nominal completed-state identifier with the specified contents of the pharmaceutical dose which has been prepared. In some examples, this connection is established by identity and / or comparison with the specification identifier. In some examples, this connection is established by derivation from the specification identifier. In some examples, this connection is established by linkage of the specification identifier and the completed-state identifier through a data structure such as a database table or other data record.

[0170] If the completed-state identifier does not match what is expected (or if there is no identifier present on the dose), the pharmaceutical preparation device can require the operator to place the correct identifier on the dose, and / or optionally accept bypassing of the container lock 180 (optionally with one or more consequences such as invalidation of the prepared dose), before the pharmaceutical preparation in fluid container 175 can be removed from pharmaceutical preparation device 210.

[0171] At block 370, in some examples, the pharmaceutical preparation device 210 transmits notification of successful verification of the dose preparation to the control server 220. The pharmaceutical preparation device 210 optionally includes documentation of the preparation (e.g., images of different stages of the preparation) together with the notification; optionally some of these are provided during the process of preparation itself, e.g., as they are recorded.

[0172] At block 375, in some examples, control server 220 signals the electronic medical records system 230 to update the status of the prescription.

[0173] Reference is now made to Fig. 4, which illustrates a flow diagram of an example method of safety-enhanced robotic preparation of a pharmaceutical dose, according to some examples of the present disclosure.

[0174] The method of Fig. 4, in some examples, uses a safety-enhancing and privacyenhancing architecture in which electronic medical records access and sensitive patient data is confined to control server 220 and / or medical records system 230. Control server 220 itself optionally avoids use of most or all sensitive identifying information apart from that needed to select correct records from medical records system 230.

[0175] Furthermore, pharmaceutical preparation device 210 is configured, e.g., as also described in relation to Fig. 3B, to retain prepared doses until the operator has properly labelled their contents.

[0176] At block 405, in some examples, processing circuitry (for example: identification device 107) scans a code indicative of an identifier of a pharmaceutical dose (i.e., a specification identifier). The code can be, for example, a bar code, QR code, text readable by optical character recognition (OCR) etc. The code can be read from a label, sticker, text printed on paper etc. In some examples, the code can be read from a radio frequency identification (RFID) tag etc.

[0177] Printing (and optionally non-scanning) examples described in relation to Figs. 3A-3B (e.g., involving printing of an identifier provided through control server 220) optionally apply to operations of block 405. Insofar as control server 220 records that it has provided 210 with a suitable identifier for printing, it optionally accepts that this identifier (e.g., on the printed carrier) will later be available for use as the completed-state identifier. Optionally, however, control server 220 requires return transmission of the identifier; e.g., as an additional precaution. Processing circuitry 215C can utilize identification device 107 or another suitable identification device (camera 140, an RFID reader etc.) to scan the code indicative of an identifier of a pharmaceutical dose. In some embodiments, identification device 107 or another suitable identification device itself provides processing circuitry 215C with the identifier. In some other embodiments, processing circuitry 215C and / or 215B (of control server 220) performs image processing and / or other suitable processing to derive the identifier from, e.g., a scanned image of a label.

[0178] In some examples, processing circuitry scans a QR code from a fluid container label that was prepared based on (e.g., assigned to represent) information in an electronic medical records system. In this manner, the present system enables generation of prescription requests based on electronic medical records data, without requiring electronic medical records access as such. For example, association of the specification identifier to personal medical data is maintained in locations other than pharmaceutical preparation device 210 itself.

[0179] At block 410, in some examples, processing circuitry 215 and / or identification device 107 directly transmit the specification identifier of the pharmaceutical dose to control server 220; e.g., via a communications link.

[0180] At block 415, in some examples, processing circuitry (for example: identification device 107) can then receive (e.g., from control server 220), data indicative of specified contents of pharmaceutical dose. This data can include, for example, the name of the prescription and the dosage, and optionally other information suitable for presentation on a user interface. The data can further include a list of materials (e.g., fluid containers, syringes, medicaments, etc.) which the operator must place in appropriate positions of the pharmaceutical preparation device in advance of the robotic dose preparation.

[0181] It is noted that in some examples, and prior to robotic preparation of the prescription, processing circuitry (for example: hardware control unit 245C) optionally transmits an additional message to control server 220 requesting permission to initiate a new preparation job, and / or to receive additional information about the preparation of the prescription, e.g., as described above, with reference to Figs. 3A- 3B.

[0182] At block 420, in some examples, processing circuitry (for example, hardware control unit 245C) locks the fluid container that will contain the final dose into the machine (e.g. , using container lock 180), and initiates execution of a robotic sequence to prepare the dose. It is noted that the locking of the fluid container can take place before the robotic sequence of preparing the dose or during the robotic sequence, and that the locking of the container can be responsive to an instruction from control server 220. At block 425, in some examples, processing circuitry 215C and / or identification device

[0183] 107 capture an image of the pharmaceutical dose. By way of non-limiting example: processing circuitry 215C, e.g., and / or identification device 107 itself, can use a pharmaceutical preparation device camera 140 that is also used for monitoring the prescription preparation process.

[0184] It is noted that in some embodiments, this imaging of the dose can be in response to an instruction from control server 220 as described above, with reference to Figs. 3A-3B.

[0185] Processing circuitry 215C and / or identification device 107 next determine (e.g., using imaging techniques) whether a dose identifier is present in the captured image of the dose, and whether the determined dose identifier (nominally expected to be the completed- state identifier) sufficiently matches the original scanned dose identifier (that is, the specification identifier).

[0186] In some examples, processing circuitry 215C and / or identification device 107 process a bar code, QR code etc. to determine the dose identifier. In some examples, processing circuitry 215C and / or identification device 107 can use a scanner, RFID reader etc. to determine the dose identifier. Optionally (e.g., additionally and / or alternatively to imaging), scanning is performed under conditions that establish, e.g., that a certain RFID identifier is physically associated with the prepared dose. For example, an RFID scanner is built into a location of pharmaceutical preparation device 210 in close proximity to the locked-in location of fluid container 175.

[0187] At block 430, in some examples: if the determined dose identifier matches the original scanned dose identifier (that is, if the nominal completed- state identifier is suitably linked to the specification identifier), processing circuitry (for example: hardware control unit 245C) unlocks fluid container 175 containing the final prepared pharmaceutical dose, thereby releasing it from the pharmaceutical preparation device. If the determined dose identifier does not match the original scanned dose identifier, processing circuitry (for example: hardware control unit 245C) can keep the dose locked until correct labeling is applied to the dose. In this manner, the pharmaceutical preparation device ensures that the dose is properly labeled — even as the specification of its contents originated remotely. Optionally, intentional bypassing of the container lock 180 is explicitly supported. Optionally, intentional bypassing of the container lock 180 the induces and / or entails making and / or marking fluid container 175 invalid for use; e.g., applying a “do not use” sticker, damaging fluid container 175, and / or draining contents fluid container 175 to a waste receptacle. Finally, processing circuitry 215 and / or identification device 107 send notification and / or evidence of completion of dose preparation and process documentation to control server 220. Control server 220 then optionally informs medical records system 230 of the new status of the pharmaceutical preparation. In this manner, pharmaceutical preparation device 210 can indirectly update the electronic medical records system 230 upon dosage completion, without necessitating access to the electronic medical records system (and attendant privacy and regulatory concerns) at the site of the dose preparation.

[0188] Reference is now made to Fig. 5, which illustrates a flow diagram of an example method of safety-enhanced robotic preparation of a pharmaceutical dose, according to some examples of the present disclosure.

[0189] The method shown in Fig. 5, in some examples, uses a safety-enhancing method in which pharmaceutical preparation device 210 retains the prepared dose until the operator has properly labelled its contents. The method shown in Fig. 5 optionally prepares prescriptions without communication to an external server. Optionally, communication occurs, but information needed for preparation the dose itself is obtained without other systemic effects on representations of dose status; e.g., without immediate updates of preparation status.

[0190] At block 505, in some examples, processing circuitry (for example, comprising and / or operating identification device 107) scans an identifier indicative of specified contents of a pharmaceutical dose to be prepared (the specification identifier). The identifier optionally comprises, for example, a bar code, QR code, text readable by optical character recognition (OCR) etc. The identifier is optionally read from a label, sticker, text printed on paper etc. In some examples, the identifier is read from a radio frequency identification (RFID) tag. The specification identifier optionally includes directly descriptive information, e.g., naming dose ingredients, amounts, and / or compounding instructions. In some examples, the specification identifier includes information at least partially abstracted from a direct description of the contents; e.g., a uniform resource locator, uniform resource indicator, database key, and / or encoding of the contents specification. Optionally, storage and / or interpretation details of the indirectly referenced information are implicit to the processing circuitry. Optionally, the indirectly referenced information is self-descriptive, e.g., insofar as it names a well-known schema, network address, and / or uses another well-known encoding and / or addressing protocol.

[0191] In some embodiments, identification device 107 or another suitable identification device provides processing circuitry 215C with the data. In some embodiments, processing circuitry 215 performs image processing and / or other suitable processing to derive the data from, e.g., a scanned image of a label.

[0192] The data indicative of specified contents of pharmaceutical dose directly and / or indirectly include, for example, the name of the prescription, the dosage, and optionally other information suitable for presentation on a user interface. The data can optionally further include a list of materials (e.g., fluid containers, medicaments, syringes etc.) which the operator must place in appropriate positions of the pharmaceutical preparation device in advance of the robotic dose preparation.

[0193] At block 510, in some examples, processing circuitry (for example: hardware control unit 245C) next locks, e.g., the fluid container that will contain the final dose into the machine (using container lock 180, for example). A robotic sequence is initiated to prepare the dose. It is noted that the locking of the fluid container can take place before the robotic sequence of preparing the dose or during the robotic sequence.

[0194] At block 515, in some examples: after sequence completion, processing circuitry 215C captures an image of the pharmaceutical dose (e.g., using camera 140 and / or identification device 107). By way of non-limiting example: processing circuitry 215 optionally uses a pharmaceutical preparation device camera 140 also used for monitoring the prescription preparation process.

[0195] Processing circuitry 215C next determines (e.g., using imaging techniques) whether a prepared dose identifier (nominally the completed-state identifier) is present in the captured image (and / or other identifying data) of the dose, and whether the determined prepared dose identifier matches (optionally upon suitable transformation and / or linkage search) the original scanned dose identifier (the specification identifier). For example, processing circuitry 215C, camera 140, camera controller 130 and / or identification device 107 can process an imaged bar code, QR code etc. to determine the dose identifier. In some examples, processing circuitry 215* uses an RFID reader or other non-imaging device to determine the dose identifier.

[0196] At block 520, in some examples: if the determined dose identifier suitably matches the originally sensed dose identifier, processing circuitry (for example: hardware control unit 245C) unlock the fluid container 175 containing the final prepared pharmaceutical dose (e.g., by unlocking container lock 180), thereby releasing the fluid container 175 from the pharmaceutical preparation device 210. If the determined dose identifier does not suitably match the original scanned dose identifier, processing circuitry (for example: hardware control unit 245C) can keep the dose locked until correct labeling is applied to the dose, the dose is rejected (e.g., if the lock is bypassed to allow resuming preparation of pharmaceutical preparations), or another corrective action is taken.

[0197] It should be understood that “matching” does not necessarily require identity of data; the term here represents a finding that a nominal completed- state identifier physically attached to a completed pharmaceutical dose (also referred to as a dose identifier) is in a suitable accordance with the specification identifier which provided original data indicative of the specified contents of the pharmaceutical dose. Optionally, it is the specified contents of the pharmaceutical dose themselves which are the subject of the matching.

[0198] In some embodiments, an identifier portion (potentially arbitrary in value and / or opaque in direct meaning in itself) is provided both as part of the originally sensed dose identifier and used as the matching component of the dose identifier. The identifier portion, in some examples, is functionally unambiguous (e.g., unique) within the operating context of pharmaceutical preparation device 210 and / or a pharmaceutical distribution system of which it is a part. Optionally, the dose identifier is derived from the original data indicative of the specified contents through a hash function, and / or otherwise transforms the original data indicative of the specified contents. Optionally, the transformation loses information (e.g., scrambles or removes it), but retains sufficient connection that a suitable matching operation is capable of detecting the connection.

[0199] The operations of Fig. 5, although they internally omit server communication, are optionally performed in relation to one or more identifiers which originate from and / or are ultimately reported on back to a remote database, e.g., a centralized server computer. Although potentially allowing more scenarios in which skew could result in principle (e.g., compared to the method of Fig. 4), there is still optionally no transmission of personally identifying information; e.g., specification identifiers optionally themselves specify (e.g., by convention) and / or are linked to full specifications for pharmaceutical preparation they are associated with, without necessarily providing additional links to identifying information. The completed- state identifier applied to the pharmaceutical preparation itself optionally includes less information, and is potentially entirely abstract, apart from enabling matching calculations.

[0200] Furthermore, the “lock until labelled” functionality, also in this example, provides a potential advantage by linking an earlier selection (e.g., the specification identifier forming a basis on which preparation operations were performed) to an eventual physically associated completion-status identification in the form of the label, RFID device, or other physical token attached to the fluid container 175 containing the completed pharmaceutical preparation. Reference is now made to Fig. 6, which illustrates an example IV bag 602 bearing a label 80 including a bar code 601, according to some examples of the present disclosure. IV bag 602 is an example of a fluid container 175, and bar code 601 is an example of an identifier pattern 85.

[0201] Following operations of prescription preparation monitored and / or gated, e.g., as described in relation to Figs. 3A-5, a fluid container 175 such as IV bag 602 released from the pharmaceutical preparation device 210 is thereafter associated automatically with validation evidence (e.g., stored by medical records system 230) that pharmaceutical preparation has been performed as specified.

[0202] General

[0203] As used herein with reference to quantity or value, the term “about” means “within ±10% of’.

[0204] The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean: “including but not limited to”.

[0205] The term “consisting of’ means: “including and limited to”.

[0206] 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.

[0207] As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0208] The words “example” and “exemplary” are used herein to mean “serving as an example, instance or illustration”. Any embodiment described as an “example” or “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0209] The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the present disclosure may include a plurality of “optional” features except insofar as such features conflict.

[0210] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0211] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0212] Throughout this application, embodiments may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of descriptions of the present disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0213] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0214] Although descriptions of the present disclosure are provided in conjunction with specific embodiments, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0215] It is appreciated that certain features which are, for clarity, described in the present disclosure in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the present disclosure. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0216] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS :

1. A safety-enhanced pharmaceutical preparation device configured to exchange contents among one or more containers to prepare a pharmaceutical dose provided in a receiving container, the device comprising: one or more identification devices operable to sense identifier patterns; a container lock; and processing circuitry and memory, the memory including instructions which configure the processing circuitry to: obtain, using the one or more identification devices, specification data indicative of specified contents of a pharmaceutical dose, lock the receiving container into the pharmaceutical preparation device, using the container lock, control the pharmaceutical preparation device to prepare the pharmaceutical dose, responsive to completion of preparation, operate the one or more identification devices to obtain completed-state identifying data identifying the receiving container including the prepared pharmaceutical dose, determine that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose, and unlock the container lock, in accordance with the determination.

2. The device of claim 1, wherein the processing circuitry determines that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose through a comparison using the completed-state identifying data and the specification data.

3. The device of claim 2, wherein the comparison checks for identity of the completed-state identifying data and the specification data.

4. The device of any one of claims 1-3, wherein the pharmaceutical preparation device comprises one or more robotic fluid transfer actuators, and the processing circuitry controls the robotic fluid transfer actuators so that the receiving container contains the pharmaceutical dose upon completion of preparation.

5. The device of any one of claims 1-4, wherein the one or more identification devices are positioned to image a carrier attached to the locked-in receiving container to obtain the completed-state identifying data.

6. The device of claim 5, wherein the one or more identification devices are configured to image the specification data from the carrier, before the receiving container is locked into the pharmaceutical preparation device.

7. The device of claim 6, wherein the carrier is a sticker, transferred to the receiving container to provide the completed-state identifying data after the processing circuitry obtains the specification data.

8. The device of claim 1, wherein the one or more identification devices comprise at least one optical camera, and the identifying data comprise at least one image obtained using the optical camera.

9. The device of claim 8, wherein the processing circuitry uses image processing to determine that the identifying data are indicative of the specified contents of the pharmaceutical dose.

10. The device of any one of claims 1-9, wherein the container lock comprises a fluid exchange connector which the pharmaceutical preparation device removes from the receiving container to unlock the container lock.

11. The device of any one of claims 1-10, wherein the container lock comprises one or more robotic fluid transfer actuators, positioned to prevent removal of the receiving container from the pharmaceutical preparation device when the container lock is locked.

12. The device of any one of claims 1-11, wherein: the container lock includes a bypass option operable to unlock the receiving container before the processing circuitry determines that the identifying data are indicative of the specified contents of the pharmaceutical dose; and operation of the bypass option results in a tell-tale of the operation of the bypass being placed upon the receiving container.

13. The device of claim 1, wherein the processing circuitry is further configured to: obtain the specification data as a specification identifier of the pharmaceutical dose; transmit the specification identifier to a control server; receive data specifying contents of the pharmaceutical dose from the control server, in response to the identifier; and transmit an indication of successful pharmaceutical preparation completion to the control server; wherein receipt of the data specifying contents of the pharmaceutical dose in exchange for the specification identifier avoids access by the pharmaceutical preparation device to personally identifying electronic medical records.

14. The device of claim 13, wherein the processing circuitry is configured to lock the receiving container responsive to an instruction from the control server.

15. The device of any one of claims 13-14, wherein the data indicative of specified contents of a pharmaceutical dose comprise an identifier received from a control server.

16. The device of any one of claims 13-15, wherein the data indicative of specified contents of a pharmaceutical dose comprise an identifier provided to the control server, the identifier specifying at least in part a present capability of the pharmaceutical preparation device.

17. The device of any one of claims 13-16, wherein the identifying data comprise a label printed according to data received from the control server.

18. The device of any one of claims 1-13, wherein the data indicative of the specified contents of the pharmaceutical dose comprise a scan of a label comprising at least one of: a barcode, a QR code, and identifier text.

19. The device of claim 18, wherein the label is a sticker.

20. The device of any one of claims 18-19 wherein the label is also used as the identifying data obtained responsive to completion of preparation.

21. The device of any one of claims 1-18, wherein the processing circuitry is configured to lock the receiving container before initiating pharmaceutical preparation.

22. The device of any one of claims 1-18, wherein the processing circuitry is configured to lock the receiving container subsequent to initiating pharmaceutical preparation.

23. A method of controlling release of pharmaceutical preparations automatically prepared by a pharmaceutical preparation device configured to exchange contents among one or more containers to prepare a pharmaceutical dose in a receiving container; the method being performed the pharmaceutical preparation device and comprising: obtaining specification data indicative of specified contents of a pharmaceutical dose; locking the receiving container into the pharmaceutical preparation device; controlling the pharmaceutical preparation device to prepare the pharmaceutical dose; responsive to completion of preparation, operating one or more identification devices to obtain completed-state identifying data identifying the receiving container including the prepared pharmaceutical dose; determining that the completed-state identifying data are indicative of the specified contents of the pharmaceutical dose; and unlocking the container lock, in accordance with the determination.

24. The method of claim 23, wherein the specification data and the completed- state identifying data are both obtained from respective images of a same label, and the image of the completed-state identifying data is obtained while the receiving container remains locked into the pharmaceutical preparation device.

25. The method of any one of claims 23-24, comprising: obtaining the specification data as a specification identifier of the pharmaceutical dose;transmitting the specification identifier to a control server; receiving data specifying contents of the pharmaceutical dose from the control server in response to the specification identifier; and transmitting an indication of successful pharmaceutical preparation sequence completion to the control server; wherein receipt of the data specifying contents of the pharmaceutical dose in exchange for the specification identifier avoids access by the pharmaceutical preparation device to personally identifying electronic medical records.

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