Imaging-based robotic pharmacy preparation sequence verification

Abstract

This invention provides a safety-enhanced drug preparation apparatus configured to exchange contents between one or more containers to prepare a drug dose in a receiving container. The exchange of contents is performed using one or more robotic fluid transfer actuators, which can be used to manipulate the one or more containers to prepare the drug dose. The drug preparation apparatus locks the drug dose in preparation into place, determining that the drug dose contains ( For example The drug preparation device is unlocked (to release it for its intended use) after identification data (displayed or otherwise presented) is consistent with the specifications of the prepared dose.

Description

[0001] Related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 605,542, filed December 3, 2023, the contents of which are incorporated herein by reference in their entirety.

[0002] Technical Field and Background Technology In some embodiments of the invention, the invention relates to the field of imaging in robotics, and more specifically, but not exclusively, to the specifications and / or validation of robotic preparation of drug dosages.

[0003] In conventional technologies, specification and validation issues have been recognized in robotic injection preparation systems. Various technologies have been developed to provide solutions. Summary of the Invention

[0004] According to one aspect of some examples of the subject matter currently described, a safety-enhanced drug preparation apparatus is provided, configured to exchange contents between one or more containers to prepare a drug dose provided in a receiving container. The apparatus includes: one or more identification devices capable of sensing an identifier pattern; a container lock; and a processing circuit system and a memory containing instructions to configure the processing circuit system to: obtain specification data of a specified content indicating a drug dose using the one or more identification devices; lock the receiving container into the drug preparation apparatus using the container lock; control the drug preparation apparatus to prepare the drug dose; in response to preparation completion, operate the one or more identification devices to obtain completion status identification data identifying the receiving container containing the prepared drug dose; determine that the completion status identification data indicates the specified content of the drug dose; and unlock the container lock based on the determination.

[0005] Based on some examples of the subject matter currently described, the processing circuitry system determines the specified contents of the drug dosage indicated by the completion status identification data by comparing the completion status identification data with the specification data.

[0006] Based on some examples of the topic currently described, the comparison check examines the consistency between the completion status identification data and the specification data.

[0007] According to some examples of the subject matter described herein, the drug preparation apparatus includes one or more robotic fluid transfer actuators, and the processing circuitry system controls the robotic fluid transfer actuators such that the receiving container contains the drug dose after preparation is complete.

[0008] Based on some examples of the subject matter described herein, the one or more identification devices are positioned to image a carrier attached to a locked receiving container to obtain the completion status identification data.

[0009] According to some examples of the subject matter described herein, the one or more identification devices are configured to image the specification data from the carrier before the receiving container is locked into the drug preparation device.

[0010] Based on some examples of the subject currently described, the carrier is a sticker, which is transferred to the receiving container after the processing circuitry obtains the specification data to provide the completion status identification data.

[0011] According to some examples of the subject matter described herein, the one or more identification devices include at least one optical camera, and the identification data includes at least one image obtained using the optical camera.

[0012] Based on some examples of the subject matter currently described, the processing circuitry system uses image processing to determine the specified contents that the identification data indicates the drug dosage.

[0013] According to some examples of the subject matter described herein, the container lock includes a fluid exchange connector, which the drug preparation apparatus removes from the receiving container to unlock the container lock.

[0014] According to some examples of the subject matter described herein, the container lock includes one or more robotic fluid transfer actuators positioned to prevent the receiving container from being removed from the drug preparation apparatus when the container lock is locked.

[0015] According to some examples of the subject matter described herein, the container lock includes a bypass option that can be used to unlock the receiving container before the processing circuitry determines that the identification data indicates the specified contents of the drug dose; and operation of the bypass option causes an indicator of bypass operation to be placed on the receiving container.

[0016] According to some examples of the subject matter described herein, the processing circuitry system is further configured to: obtain the specification data as a specification identifier for the drug dosage; transmit the specification identifier to a control server; receive data of the contents specifying the drug dosage from the control server in response to the identifier; and transmit an indication of successful completion of drug preparation to the control server; wherein receiving the data of the contents specifying the drug dosage in exchange for the specification identifier prevents the drug preparation device from accessing personally identifiable electronic medical records.

[0017] Based on some instances of the subject matter described herein, the processing circuitry is configured to lock the receiving container in response to instructions from the control server.

[0018] Based on some instances of the subject matter described herein, the data indicating a specific content for a drug dosage includes identifiers received from a control server.

[0019] Based on some instances of the subject matter described herein, the data indicating a specified content for a drug dosage includes an identifier provided to the control server, the identifier at least partially specifying the current capabilities of the drug preparation apparatus.

[0020] Based on some instances of the topic currently described, the identification data includes labels printed based on data received from the control server.

[0021] Based on some instances of the subject matter described herein, the data indicating the dosage of the specified contents includes a scan of a label, which includes at least one of the following: a barcode, a QR code, and identifier text.

[0022] Based on some instances of the topic currently being described, the label is a sticker.

[0023] According to one aspect of some instances of the subject currently described, the apparatus is provided, wherein the tag also serves as the identification data obtained in response to completion of preparation.

[0024] Based on some examples of the subject matter described herein, the processing circuitry system is configured to lock the receiving container prior to initiating drug preparation.

[0025] Based on some examples of the subject matter described herein, the processing circuitry system is configured to lock the receiving container after drug preparation has been initiated.

[0026] According to one aspect of some examples of the subject matter currently described, a method is provided for controlling the release of a pharmaceutical preparation automatically prepared by a pharmaceutical preparation apparatus configured to exchange contents between one or more containers to prepare a drug dose in a receiving container; the method is performed by the pharmaceutical preparation apparatus and includes: obtaining specification data of a specified content indicating a drug dose; locking the receiving container into the pharmaceutical preparation apparatus; controlling the pharmaceutical preparation apparatus to prepare the drug dose; in response to preparation completion, operating one or more identification devices to obtain completion status identification data identifying the receiving container containing the prepared drug dose; determining that the completion status identification data indicates the specified content of the drug dose; and unlocking the container lock based on the determination.

[0027] Based on some instances of the subject matter described herein, the specification data and the completion status identification data are both obtained from corresponding images of the same label, and the image of the completion status identification data is obtained while the receiving container remains locked into the drug preparation apparatus.

[0028] According to some examples of the subject matter described herein, the method includes: obtaining the specification data as a specification identifier for the drug dosage; transmitting the specification identifier to a control server; receiving data of contents specifying the drug dosage from the control server in response to the specification identifier; and transmitting an indication of successful completion of a drug preparation sequence to the control server; wherein receiving the data of contents specifying the drug dosage in exchange for the specification identifier prevents the drug preparation device from accessing personally identifiable electronic medical records.

[0029] 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 this disclosure pertains. While similar or equivalent methods and materials may be used in the practice or testing of embodiments of this disclosure, exemplary methods and / or materials are described below. In case of conflict, the patent specification containing the definitions shall prevail. Furthermore, materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0030] As those skilled in the art will understand, aspects of this disclosure can be embodied as systems, methods, or computer program products. Therefore, based on this disclosure and the current state of the technology, aspects of this disclosure can be presented as entirely hardware embodiments, entirely software embodiments (including firmware, resident software, and microcode), and more. wait (or a combination of software and hardware embodiments, all of which are generally referred to herein as "circuit", "module" or "system"). For example The method can be implemented using a "computer circuit system" or a "processing circuit system".

[0031] Furthermore, aspects of some embodiments of this disclosure may be in the form of a computer program product embodied in one or more computer-readable media having computer-readable program code embodied thereon. Implementation of methods and / or systems of some embodiments of this disclosure may involve performing and / or completing selected tasks manually, automatically, or in combination thereof. Furthermore, based on instruments and equipment provided for implementing some embodiments of one or more methods and / or systems of this disclosure, selected operations of these methods and / or systems may be implemented in various ways, by hardware, by software, by firmware, and / or by combinations thereof.

[0032] For example, the hardware for performing selected operations according to some embodiments of this disclosure is optionally implemented as a chip or circuit. As software, the selected operations according to some embodiments of this disclosure are optionally implemented as a plurality of software instructions. Optionally, the implementation is built on a general-purpose computing device. For example , utilizing the services of the operating system.

[0033] In some instances of this disclosure, one or more operations performed in one or more methods and / or by one or more systems are executed by a data processor, which is, for example, a computing platform configured to execute multiple instructions sequentially and / or simultaneously. Such a data processor may alternatively be referred to herein as… For example "Digital processor" refers to a data processor that operates using digital bit groups, and / or "processing circuit system" refers to an electronic circuit system used in data processing applications.

[0034] The instruction execution element of a data processor may include, for example, one or more microprocessor chips, ASICs, and / or FPGAs. Optionally, the data processor includes volatile memory for storing instructions and / or data; and / or non-volatile memory for storing instructions and / or data, such as magnetic hard disks and / or removable media. The terms “non-volatile memory” and “non-volatile storage medium” as used herein should be broadly interpreted to cover any volatile or non-volatile computer memory suitable for the subject matter currently disclosed.

[0035] Optionally, a network connection enabling data communication is provided. Optionally, a display and / or user input device, such as a keyboard or mouse, are provided. Any of these implementations is more generally referred to herein as... For example Examples and / or components of computer circuit systems and / or processing circuit systems.

[0036] Some examples of this disclosure may use any combination of one or more computer-readable media. Computer-readable media may be computer-readable signal media or computer-readable storage media. Without limitation, computer-readable storage media may include systems, devices, or apparatuses implemented, for example, electronically, magnetically, optically, electromagnetically, infraredally, and / or semiconductorally; in any suitable combination.

[0037] A non-exhaustive list of other instances of one or more computer-readable storage media includes: electrical connections having one or more wires, portable computer floppy disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable optical disc read-only memory (CD-ROM), optical storage devices, and magnetic storage devices. Optionally, any suitable combination of the foregoing may be provided.

[0038] In the context of this document, a computer-readable storage medium can be any tangible medium that contains or stores programs for use by or in conjunction with an instruction execution system, device, or apparatus. A computer-readable storage medium may also contain or store information for use by such programs; for example, data structured in a manner recorded in a computer-readable storage medium such that a computer program can access it as, for example, one or more tables, lists, arrays, data trees, and / or other data structures. In this document, a computer-readable storage medium that records data in a form that can be retrieved as groups of digits is also referred to as a digital memory. It should be understood that in some instances, where the computer-readable storage medium is not inherently read-only and / or is in a read-only state, it may optionally also be used as a computer-writable storage medium.

[0039] Certain data are optionally referred to herein as data derived from one or more sensors. For example "Sensing data" and / or "sensor data". This type of data includes one or more physical effects converted into a machine-readable form. For example One or more of the computer-readable media described herein. Sensing / sensor data optionally represent physical quantities and / or objects. For example Measurements and / or images. Sensed data is typically converted into digital form for use in data processing. However, analog form is not excluded. For example Use appropriate analog circuit systems to encode the amplitude, frequency, and / or phase of voltage and / or current; For example (For comparison and / or combination operations) Transmit, maintain and / or process sensed data.

[0040] In this article, the data processor (optionally referred to as...) For example The processing circuit system and / or computer circuit system are allegedly "configured" to perform data processing actions. For example The data processor, according to one or more algorithms, accesses and / or manipulates stored and / or streaming data, processes the instructions and / or data, and / or stores the processing results in the same or another computer-readable medium, as long as the data processor is coupled to a computer-readable medium to receive instructions and / or data therefrom. The performed processing (… For exampleThe processing (using stored and / or streaming data) is specified by instructions, the effect of which is that the processor operates according to the instructions. The actions of processing may be referred to by one or more other terms, such as: comparison, estimation, determination, calculation, operation, comparison, encryption, decryption, identification, association, storage, access, reception, acquisition, analysis, selection, and / or transformation. For example, in some instances, the processing circuitry accesses and / or receives instructions and data stored in volatile and / or non-volatile memory and / or provided via a communication link, processes the data according to the instructions, stores the processing results in volatile and / or non-volatile memory, and / or provides the processing results. In some instances, "providing" the processing results includes one or more of transmitting, storing, and / or presenting the processing results. Presentation optionally includes displaying on a display, providing sound instructions, printing on a printout, or producing the results in a form accessible to human senses.

[0041] Computer-readable signal media optionally include propagated data signals embodying computer-readable program code therein; for example, in baseband and / or as a carrier wave portion. Such propagated signals can take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium can be any computer-readable medium that is not a computer-readable storage medium and can convey, propagate, or transport a program for use by or in conjunction with an instruction execution system, device, or apparatus.

[0042] The program code embodied on a computer-readable medium and / or the data used therefrom may optionally be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF... wait Or any suitable combination thereof.

[0043] Computer program code used to implement some examples of this disclosure may optionally be written in any combination of one or more programming languages; for example, object programming, procedural and / or functional programming languages. Non-limiting examples include C, Java, Smalltalk, C++, Python, ECMAScript (… For example JavaScript and Rust, as well as many other programming languages ​​known to those skilled in the art. As is known to those skilled in the art, programs written in such languages ​​specify logical operations that can be translated in various ways before and / or during processing into computer instructions suitable for direct use by a particular instance of a processing circuit system.

[0044] Alternatively or concurrently, logical operation sequences ( For exampleThe program code (in the form of instructions derived from the machine instruction set supported by the processing circuit system) can be embedded in the design of an ASIC and / or in the configuration of an FPGA device. The program code can be executed entirely or partially on the user's computer. For example It can be executed (as a standalone software package) partly on the user's computer and partly on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer can be connected to the user's computer via any type of network including a local area network (LAN) or a wide area network (WAN), and / or can connect to external computers (e.g., via the Internet using an Internet service provider).

[0045] Examples of this 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, those skilled in the art will understand that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented using appropriate computer program instructions to apply the teachings provided herein. These computer program instructions are available for use with general-purpose computers, special-purpose computers, or other programmable data processing devices. For example A processor (processing circuit system) to produce a machine; such that the instructions, upon execution thereon, perform the functions and / or operations specified in one or more blocks of a flowchart and / or block diagram.

[0046] 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 means to operate in a particular manner, such that the instructions stored in the computer-readable medium produce an article of writing containing instructions that implement functions / actions specified in one or more boxes of a flowchart and / or block diagram.

[0047] Computer program instructions may also be loaded onto a computer, other programmable data processing apparatus or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer-implemented process, such that the instructions, which execute on the computer or other programmable apparatus, provide for performing a process for carrying out a function / action specified in one or more boxes of a flowchart and / or block diagram.

[0048] Some of the methods described in this article are typically designed for computer use only; and may be infeasible or impractical for human experts to perform entirely manually. If feasible ( For example For example, examining objects and / or making determinations based on data; human experts who want to perform similar tasks manually can expect to use entirely different approaches. For example It utilizes human expert knowledge and / or the pattern recognition ability of the human brain. Attached Figure Description

[0049] Some embodiments of this disclosure are described herein with reference to the accompanying drawings and examples only. Detailed reference is now made to the drawings, and it should be emphasized that the details shown are by way of example and for the purpose of illustrative discussion of embodiments of this disclosure. In this regard, the description taken in conjunction with the drawings will make it clear to those skilled in the art how embodiments of this disclosure can be practiced.

[0050] In the diagram: Figure 1 Examples of robotic drug preparation apparatuses according to some embodiments of the present disclosure are shown; Figure 2 Examples of a security-enhanced drug preparation apparatus deployed to communicate with a control server and / or a medical record system, according to some embodiments of the present disclosure, are shown. Figure 3A The initial steps of an example event sequence for safety-enhanced robotic drug dosing preparation according to some examples of this disclosure are shown; Figure 3B The steps of an example event sequence for safety-enhanced robotic drug dosing preparation according to some examples of this disclosure are shown; Figure 4 A flowchart illustrating an example method for preparing a safety-enhanced robot for drug dosage according to some examples of this disclosure; Figure 5 Flowcharts illustrating example methods for the preparation of a drug dosage safety-enhanced robot according to some examples of this disclosure are shown; and Figure 6 Example IV bag is shown as an example of a label containing a barcode, according to some examples of this disclosure. Detailed Implementation

[0051] In some embodiments of the invention, the invention relates to the field of imaging in robotics, and more specifically, but not exclusively, to the specifications and / or validation of robotic preparation of drug dosages.

[0052] Overview One aspect of some embodiments of this disclosure relates to a safety-enhanced drug preparation apparatus. The drug preparation apparatus is configured to exchange contents between one or more containers to prepare a drug dose and to provide the drug dose in a receiving container. In some instances, the exchange of contents is performed using one or more robotic fluid transfer actuators that can be used to manipulate one or more containers to prepare a drug dose and / or transfer a drug dose and / or portions thereof between containers.

[0053] In addition, in some instances, the drug preparation apparatus includes one or more identification devices that can be used to sense the identifier pattern, optionally including one or more cameras, RFID sensors and / or another type of identification data sensor.

[0054] In some instances, the pharmaceutical preparation apparatus includes one or more elements serving as a container lock. The container lock optionally includes a dedicated device that locks to prevent manual removal of the receiving container, and / or utilizes other components of the pharmaceutical preparation apparatus to lock the receiving container to prevent manual removal. In some instances, the container lock includes a fluid container attachment, which the pharmaceutical preparation apparatus also uses as a conduit through which fluid is transferred into and / or from the receiving container. Optionally, the lock includes a bypass opening mode for use when needed; optionally, bypass operation includes placing an indicator on the receiving container that prevents and / or blocks the use of its contents.

[0055] In some instances, the drug preparation apparatus includes a processing circuitry system and a memory containing instructions for configuring the processing circuitry system for its operation.

[0056] In some instances, drug preparation apparatuses (e.g., their processing circuitry systems) use identification devices to obtain specification data of designated contents indicating drug dosage. The data optionally includes directly indicative information, such as ingredient specifications, quantities, and / or instructions for preparing drug dosages. Optionally, the data is indirectly indicative; for example, the data provides an address, a number selected from a series of numbers, an arbitrarily selected key to a database entry, an identifier derived at least in part from data related to drug dosage (e.g., a tracking number including one or more information fields), the output of a hash function, or another type of reference data.

[0057] In some instances, the drug preparation apparatus uses a container lock to lock the receiving container into the drug preparation apparatus at some point before or during drug preparation. Optionally, locking includes attaching the receiving container to the device where fluid transfer occurs.

[0058] The drug preparation device uses one or more robotic fluid transfer actuators to initiate a drug preparation sequence to prepare a drug dose.

[0059] In response to the completion of a drug preparation sequence, in some instances, the drug preparation apparatus operates one or more identification devices to obtain completion status identification data that identifies a receiving container holding a dose of the prepared drug. In some instances, the completion status identification data is carried and / or displayed by a physical identification token, which includes, for example, a printed pattern and / or electronic device placed on the receiving container. For example, the carrier of the completion status identification data attached to the receiving container includes a sticker.

[0060] In some instances, the completion status identification data and specification data are substantially the same and / or equivalent. For example, the same sticker (or otherwise affixed label) of the specification data, which serves as an indicator of the specified contents for the drug dosage, is then applied to the receiving container to act as a carrier of the completion status identification data. In some instances, the completion status identification data is a separate copy from the carrier of the specification data; for example, these carriers are two separate copies of the same identifier pattern. In some instances, the completion status identification data and specification data are otherwise related; for example, linked in databases, sharing one or more portions of the data they carry, deriving one from the other via hashing or another algorithm (e.g., in at least one direction), and / or otherwise interconnected as data. This link allows the determination of the specified contents for the drug dosage from the completion status identification data (directly and / or indirectly).

[0061] For example, even when the specified contents for a drug dosage cannot be directly determined from the completion status identification data, the specification data of the specified contents indicating the drug dosage may optionally be determined. Thus, the specified contents may be optionally determined. The determination of the indicative specification data may optionally include transformation of the completion status identification data itself, and / or include searching; example like This is used to determine which of the multiple indicative specification data entries the completion status identification data is derived from and / or linked to.

[0062] In some instances, such as after appropriate information describing the specified contents of a drug dosage is directly linked to completion status identification data in a data structure stored by a medical record system and / or other data storage device, the maintenance link between specification data and completion status identification data is omitted and / or deleted.

[0063] In some instances, placement of the carrier for completion status identification data occurs before the receiving container is locked in place and / or before drug preparation is actually completed. For example, the receiving container may optionally be pre-designated for its specific purpose and has a label carrying the completion status identification data. In some instances, placement is performed when the receiving container is locked in place; for example, by a device operator (e.g., by placing a sticker on the receiving container) and / or automatically.

[0064] After determining the specified contents for which the completed status identification data indicates the drug dosage, the drug preparation device unlocks the container lock accordingly.

[0065] Using identification-dependent unlocking offers the potential advantage of ensuring that, for example, mislabeled and / or partially prepared drug doses are not mistaken for correctly formulated doses and thus misused.

[0066] Before explaining at least one embodiment of this disclosure in detail, it should be understood that this disclosure is not necessarily limited in its application to the details of the construction and arrangement of components and / or methods set forth in the following description and / or shown in the drawings and / or given in the examples. The features described in this disclosure, including those of the invention, can have other embodiments or can be practiced or implemented in various ways.

[0067] Drug preparation apparatus and system Drug preparation device For reference Figure 1 The example shown is a robotic drug preparation apparatus 210 according to some examples of the present disclosure.

[0068] exist Some In this example, the syringe manipulation subsystem 120 includes a subsystem for manipulating the syringe; for example, by using clamp 105 to clamp / release syringe 156. For example The syringe barrel 155 is used to draw fluid from the fluid container 175 into the syringe barrel 155, and / or to inject fluid from the syringe barrel 155 into the fluid container 175. In this document, the fluid container 175 is also referred to as the “receiving container”.

[0069] The syringe manipulation subsystem 120 includes a portion of a robotic fluid transfer manipulator 121. In some instances, the fluid transfer manipulator 121 includes a container transport 171. In summary, the actuation capability of the fluid transfer manipulator 121 enables the movement of containers between locations and / or causes the movement of fluid, thereby resulting in transfer between containers (e.g., containers coupled via one or more fluid exchange connectors 165). These capabilities are also referred herein as “robotic capabilities” and / or “robotic fluid transfer actuators”; for example, actuators by which fluid is transferred as it is contained and / or exchanged between containers. Optionally, the fluid transfer generally involves more than one interconnection; for example, the syringe 156 is optionally used to transfer fluid to and / or from one or more vials and / or IV bags containing a pharmaceutical substance before finally transferring the fluid to a receiving container (e.g., another vial and / or IV bag), the receiving container being a container carrying (containing) a prepared dose for delivery to a next recipient.

[0070] The actuator assembly of the fluid transfer manipulator 121 includes, for example, a motor, belt, transmission, housing, position sensor, bearing, and / or support members. The operations performed herein by the drug preparation apparatus 210 using the fluid transfer manipulator 121 during drug dosage preparation are also referred to herein as a “sequence,” such as a sequence of operations for mixing materials between multiple containers to produce (e.g., by mixing, dissolving, stirring, transferring, and / or otherwise manipulating the contents of containers) a pharmaceutical formulation (also referred to herein as a “dosage”). It should be understood that the pharmaceutical formulation is not necessarily a single-dose formulation.

[0071] Optionally, the syringe needle 185 is inserted into a fluid exchange connector 165, which is in turn attached to a fluid container 175. Optionally, the syringe plunger 145 is inserted into a syringe barrel 155.

[0072] In some instances, a container lock 180 is provided, which the system controller 110 operates to control the release of the fluid container 175 from the drug preparation device 210. Optionally, the locking function is performed by one and / or another component of the fluid exchange connector 165. For example, a component of the container transport 171, such as a robotic arm manipulating the fluid container 175 into place, optionally grips, covers, blocks the movement of the fluid container 175, or otherwise interferes with the release of the fluid container from the drug preparation device 210 until the system controller 110 is ready to release the fluid container 175. The syringe connector 165 and / or another component having a dual locking purpose should also be understood as components of and / or the container lock 180 itself.

[0073] In this document, container lock 180 is claimed to “lock” fluid container 175 into drug preparation apparatus 210, at least in relation to preventing and / or interrupting the conventional sequence of physical operations for removing the fluid container from its location after preparation of the drug formulation contained in fluid container 175. Optionally, the interruption is characterized by introducing one or more steps involving overcoming one or more interfering elements that are not normally interfering and / or not normally difficult to remove from a disturbing location.

[0074] In this document, overcoming interference elements beyond normal unlocking conditions (e.g., optionally supporting such overcoming as an intentional feature of the device) is referred to as “bypassing” the container lock 180. Bypassing the container lock 180 optionally requires… For example Using unusual tools, approaching unusual and / or hard-to-reach ports and / or mechanisms, applying force that is not normally needed, and / or entering user interface patterns with obvious indications that the container lock 180 is being bypassed.

[0075] In some instances, bypassing container lock 180 results in the invalidation of the prepared (or partially prepared) pharmaceutical formulation, at least with respect to the processes of the pharmaceutical preparation system 200, of which pharmaceutical preparation apparatus 210 is part, and / or processes associated with the original intended use of the pharmaceutical formulation. Optionally, this includes data indications associated with records of pharmaceutical preparation (…). example like (Invalid flag). Optionally, bypassing container lock 180 will generate an indicator indication on fluid container 175. For example Stains, color markings, damage, and / or other physical indications. In some instances, lock bypass procedures include operators creating or applying such markings; For example A designated color, rejection label, or other visual indication is applied to fluid container 175 so that it will be identified as unusable or invalid. In some instances, the indicator includes the removal of contents from fluid container 175. In some instances, such as when a sensor of camera 140 images the bypass indicator, lock bypass is completed when system controller 110 identifies the indicator object and / or condition and releases container lock 180 accordingly.

[0076] In some embodiments, the syringe manipulation subsystem 120 includes a plunger arm controller 170 that can physically control a mechanical plunger arm 135 to withdraw a syringe plunger 145 from a syringe barrel 155, thereby drawing fluid from a fluid container 175 into the syringe barrel 155. Similarly, the plunger arm controller 170 can physically control the mechanical plunger arm 135 to push a syringe plunger 145 into the syringe barrel 155, thereby discharging fluid from the syringe barrel 155 into the fluid container 175.

[0077] Fluid container 175 optionally includes For example A vial or bag containing fluid. In some instances of this disclosure, a label 80 is provided for use with the fluid container 175. An identifier pattern 85 is provided on the label 80. For example (Displayed as part of the printing on label 80). More generally, label 80 is an instance of the "carrier" of identifier pattern 85 (and correspondingly an instance of the carrier of data represented by the identifier pattern).

[0078] Optionally, the identifier pattern 85 is attached to the fluid container 175 only at the end of the preparation operation (e.g., as a sticker attachment). The identifier pattern includes, for example, a barcode, QR code, and / or text to be used as an identifier. In some instances, the label 80 remains separate from the fluid container 175 until a certain stage of drug preparation is reached. For exampleThe mixing operation is then complete. In some instances, the tag 80 and its associated identifier pattern 85 (and identifier) ​​are pre-associated with the intended drug formulation. In any of these cases, the identifier pattern 85 specifically associated with the receiving container is also referred to herein as delivering “completion status identification data”.

[0079] It should be noted that when the carrier of the completion status identification data is attached to the receiving container before the actual completion status of drug preparation is reached, confusion may be prevented by allowing the drug preparation device 210 and / or the system communicating with it to wait for the operation to complete before actually recording the identification data containing the characters of the "completion status" identification data.

[0080] The syringe manipulation subsystem 120 optionally includes a clamp controller 160, which can physically control the clamp 105 to clamp or release the syringe barrel 155. In some instances, system controller 110 includes a separate controller that contains processing circuitry 115 and memory 125. Optionally, system controller 110 is operatively connected to syringe manipulation subsystem 120 (e.g., via bus or network). In some embodiments, system controller 110 can command syringe manipulation subsystem 120, for example, to dispense a specified amount ( For example A fluid (e.g., a drug to be injected into a patient) is aspirated into and / or discharged from the syringe barrel 155.

[0081] In some instances, one or more cameras 140 (any one or more of which optionally also serve as identification devices 107) include digital cameras configured for optical monitoring. For example The components of the drug preparation system 210 and / or the operation performed by the syringe manipulation system 120. Optionally, one or more cameras 140 are positioned such that they are positioned from a corresponding specific distance (optionally, [missing information]). For example Digital images of, for example, syringe components and / or other container contents are captured via a distance range selected by focusing adjustment and / or movement of one or both of the cameras 140 and / or syringe barrel 155 and / or fluid container 175; referred to herein as camera distance 195. Also associated with camera 140 is a field of view 141, which is oriented and / or adjustable to be oriented to include at least a portion of syringe barrel 155 and / or fluid container 175. Optionally, this is used to allow imaging of label 80 and / or identifier pattern 85. For example (Once placed on fluid container 175). In some embodiments, camera 140 relative to... For example The syringe barrel 155 is located in a fixed position. In some embodiments, the camera 140 may be relative to... For exampleThe syringe barrel 155 can be moved manually or automatically to different positions or distances.

[0082] Optionally, camera controller 130 is operatively connected to camera 140. The camera controller can implement camera control methods and can provide digital images to system controller 170. Optionally, system controller 170 is operatively connected to camera controller 130.

[0083] In some instances, an identification device 107 is provided as a supplement to and / or alternative to camera 140, the identification device being configured to identify tokens ( For example (Including optical and / or radio frequency operating scanning devices) sensing identifier patterns, example like As described herein. In some instances, camera 140 itself performs the functions of identification device 107, optionally along with other functions performed by camera 140. Alternatively or additionally, identification device 107 includes a printer ( For example (Label printer) and / or provided with the printer.

[0084] System-level control of drug preparation Components and Communication For reference Figure 2 This illustrates examples of a security-enhanced drug preparation apparatus deployed to communicate with a control server 220 and / or a medical record system 230, according to some embodiments of the present disclosure. The medical record system 230, one or more control servers 220, and one or more drug preparation apparatuses 210 together comprise a distributed drug preparation system 200.

[0085] In some instances, the electronic medical record system 230 includes a computer system comprising a processing circuitry system 215A and a memory 225A. The electronic medical record system 230 optionally includes a patient record database 255, which includes data related to prescriptions for individual patients. In some instances, the records in the patient record database 255 also maintain records of prescriptions prepared for drug administration. For example It will be prepared, it has been prepared, and in particular, the preparation that has taken place is in accordance with the specified instructions ( For example Evidence (based on the specified prescription).

[0086] In some instances, control server 220 includes a computer system comprising processing circuitry 215B and memory 225B. Optionally, control server 220 is operatively connected to electronic medical record system 230 and drug preparation apparatus 210. For example(via a corresponding communication link). The control server 220 is configured to perform functions before and / or during the preparation of drug dosages; For example , such as regarding Figures 3A to 5 As described.

[0087] In some instances, the drug preparation apparatus 210 includes hardware and controller components. For example As mentioned above Figure 1 As described. Optionally, the drug preparation apparatus 210 itself includes a processing circuit system 215C and / or a memory 225C. In some instances, the processing circuit system 215C and the memory 225C include functional modules such as a user interface 260, an identification device 107 (again, this is optionally provided as one or more cameras 140), and / or a hardware control unit 245C.

[0088] In some embodiments of this disclosure, a human operator directly participates in one or more operational phases. Optionally, human presence and / or participation are required by regulations and / or risk management procedures associated with the operation of the drug preparation apparatus 210 and / or drug preparation system 200. Human-dependent procedural operations, such as one or more user confirmations, user-initiated commands, identifier sensing and / or identifier attachment, are also possible. Right now (Attachment of the carrier of the completed state identification data) optionally serves to ensure, demonstrate, and / or record the appropriate ( ) input during the drug preparation process. For example (The degree of human attention required to comply with regulations and / or approved procedures, even if many aspects of the process are originally automated.)

[0089] In this regard, it should be noted that human capabilities and machine capabilities may be complementary in their relative strengths. For example The breadth of human judgment and the reproducible behavior of machines. While generally performing well in accurately and precisely executing repetitive tasks, a general risk of machine operation is the potential failure to notice and / or react to anomalies occurring outside of defined parameters. Furthermore, a potential advantage is freeing human operators from narrower responsibilities (…). For example This liberates human beings from the measurement and / or transfer of the material itself, in order to gain more benefit from human judgment and conscious capacity. In some instances of this disclosure, human and machine activities are intertwined through the participation of both in record-keeping practices related to drug preparation.

[0090] Pull / Push Operation Allocation In some instances, the entire drug preparation process is managed according to a pull / push model, where the drug preparation device 210 and / or its operator signals machine readiness by “pulling” the next preparation job from the medical record system 230 via the control server 220 (optionally with or without prior information about what the job will be). Following communication with the medical record system 230, the control server 220 responds with a “push” describing the job.

[0091] The operation is described firstly with respect to the drug preparation apparatus 210 and / or its operator needing to complete the next operational phase under their responsibilities, but optionally... No The description is comprehensive enough to allow the job to be fully completed without further communication. Therefore, in some instances, one or more additional push / pull phases exist as the various stages of the pharmaceutical preparation operation begin and / or complete. As part of these communications, one or more identifiers are shared, becoming part of the records associated with the job, the patient, and / or the pharmaceutical preparation itself.

[0092] In some instances, the “pull” side of the job (where drug preparation actually takes place) is optionally started without knowledge of the specific details of the job parameters.

[0093] However, optionally, at least some knowledge of the relevant operational parameters exists. In one instance: there may be certain preparation materials available for a particular drug preparation apparatus 210 (and possibly not all preparation materials used throughout the system), making it suitable (or unsuitable) for certain operations known to the control server 220 and / or the medical record system 230. Optionally, initial communication from the drug preparation apparatus 210 is used to indicate the capability status to the control server 220.

[0094] Optionally, at least some aspects of this capability indication are provided using an “identifier,” or more specifically, using an identifier also referred to herein as an “initial” or “original” identifier. This identifier is also, and more specifically, interchangeably referred to herein as a “specification identifier” and “specification data indicating the specified contents” of the pharmaceutical preparation. The identifier is optionally provided using a token without a specific initial meaning, which is given meaning in communication and / or recording through the operation of the pharmaceutical preparation system 200. Optionally, the specification identifier… indeed It has a certain initial significance ( For example (which may be optionally associated in advance with the preparation, type, requirements and / or capabilities of a prescription), and gain further meaning through communication and / or record keeping activities associated with drug preparation.

[0095] Meaning of specification identifiers In some instances, the specification identifier itself is "merely" the "glue" between the physically labeled pharmaceutical preparation and its data representation in the drug preparation system 200—optionally unique in itself, but otherwise not previously associated with any meaningful information. For example, the specification identifier is optionally selected (for a period of time before and / or after the commencement of communication between the drug preparation apparatus 210 and the control server 220) For example (as the "next in line" number and / or selected from the label stack) and / or arbitrarily and / or randomly ( For example Algorithmic allocation.

[0096] Alternatively, for one or more participants in the drug preparation system 200, this identifier itself indicates part to all details associated with drug preparation. Specific identifiers may have been pre-assigned for identification. For example Preparation location, final delivery location, a set of preparation capabilities, a set of preparation materials on hand 210, and / or another status and / or requirement. Optionally, the identifier has been associated with a specific prescription and / or patient.

[0097] In some instances, the identifier is also associated with a physical carrier; For example These are printed labels, RFID devices, or other objects provided as "scannable identifiers," meaning objects that can undergo at least automated sensing (inspection) to determine the value of the identifier itself. In some instances, the identifier includes one or more visual indicators, optionally human-readable visual indicators. For example It contains alphanumeric characters.

[0098] In some instances, scannable identifiers are associated with the preparation of material kits. For example The kit is included in its packaging. Optionally, prior to the preparation of a specific drug, the preparation material kit is assembled in a generic manner (separate from knowledge of a specific patient's prescription) and assigned a complete or partial identifier on this basis. Optionally, the kit is pre-specified for use in preparing a specific prescription ( Right now (For prescriptions for specific patients). Optionally, a scannable identifier may be provided independently.

[0099] When the operation sensor of the drug preparation device 210 ( For example When scanning and transmitting data from label 80 or other articles bearing a given identifier pattern 85 carrying a specification identifier, it optionally instructs control server 220 and / or medical record system 230 that a particular drug preparation device 210 is ready to work with a particular set of materials, which are optionally at least partially generic and / or optionally associated with a particular prescription. In some instances ( For exampleFor carriers that begin as at least independent carriers of scanable identifiers, only a direct association exists between the identifier and the prescription, while capability is left as a separate consideration. For example In some instances, this is assumed to be sufficient.

[0100] Although there may be some degree of specific pre-designation of the prescription and / or its required identifiers, optionally, the drug preparation device 210 may not initially have access to additional required information: For example It may not know the exact quantity of materials to be used. It may not possess specific information about the pre-specified components. In other words, the full characters of the identifier, which serves as a "specification" identifier, are optionally not initially accessible to the drug preparation apparatus 210.

[0101] Additionally or alternatively (and conversely), the recording and control system, including the control server 220 and / or the medical record system 230, may not know the exact disposal of materials that have been or will be associated with the prescription (i.e., not including accurate and / or updated records of them) until the drug preparation device 210 signals that it is available to mix materials suitable for and / or specified for the prescription.

[0102] Furthermore, information available to one party may not be available to another. For example, the facility operating the drug preparation apparatus 210 may select and assign identifiers according to a scheme specified for its own internal purposes, without reference to the control server 220. Conversely, the facility operating the drug preparation apparatus 210 may have been assigned a set of identifiers externally, which have meanings associated with data stored by the control server 220 and / or the medical record system 230, but whose meanings cannot be determined from the identifiers themselves. Optionally, the final version of the specification identifiers associated with the drug formulation is assembled from a plurality of individual identifiers, which are optionally first generated and assigned to one or more of a plurality of agents involved in the overall logistics of the drug formulation, and / or have significant meaning to the agents.

[0103] Scan-gated drug preparation For reference Figure 3A It illustrates the initial steps of an example event sequence for safety-enhanced robotic drug dosing preparation according to some examples of this disclosure.

[0104] It should be understood that the examples provided in this document in the form of flowcharts indicate one or more sequences of operations as examples and / or as indications of conceptual order. The indicated order does not limit the order of operations in other instances involved in the flowcharts. For example, operations may optionally occur in different orders and / or at least partially simultaneously. For exampleThis applies when neither operation is strictly dependent on the output of the other to begin. In some cases, operations are optional and / or susceptible to alternative implementations; for example, as discussed in the description associated with the graph.

[0105] Communication gating state in drug preparation Figure 3A The operation provides an example where the specification identifier of the pharmaceutical preparation is closely linked to the initiation of its mixing process. This process then optionally leads to (e.g., as per [reference to...]). Figure 3B The physical association between a completion status identifier (e.g., a sticker) and a pharmaceutical preparation.

[0106] In principle, it can be allocated at any stage as System unique identifier and specific drug formulations Physically related Attributes; For example In advance, at any time, an empty fluid container 175 designated for storing a specific pharmaceutical preparation is labeled and included together with a material kit designated for manufacturing the preparation.

[0107] In some instances of this disclosure, the final completion status identifier is at least For example Pre-assigned by medical record system 230, and optionally ( For example The pre-mixed pharmaceutical preparation (as a physical tag or other carrier) is sent to the physical location of the pharmaceutical preparation in the pharmaceutical preparation apparatus 210. Alternatively, a pre-allocated and / or on-demand generated completion status identifier may be printed out or otherwise incorporated into a label or other carrier at the physical location of the mixed pharmaceutical preparation in the pharmaceutical preparation apparatus 210. However, even in such cases, there may be potential advantages to tracking effectiveness and / or system safety by delaying the full identification of the completion status identifier as an indication of the finished pharmaceutical preparation until certain conditions are met through the use of the procedure.

[0108] about Figure 3A The description involves establishing early conditions for some instances of this disclosure; regarding Figure 3B The description involves establishing post-construction conditions. Regarding... Figure 4 The description provides For example according to Figures 3A to 3B Another example of the described dosage preparation verification and / or safety. Figure 5 Instances omitted ( Right now This makes it optional) related to centralized and / or server communication. For example Optionally, operations may be restricted to the local device in most or all of the methods.

[0109] Figure 3A The method includes a digital handshake involving time definition (i.e., "occurring during a defined time period") of each of the drug preparation device 210, control server 220, and medical record system 230. This digital handshake helps define... system Preparation state of the range Before this digital handshake occurs, the control server 220 can... For example By consulting the medical record system 230, one can "know" that the drug formulation in question has not yet been prepared by the operation of the drug preparation system 200, even if some or all of the materials involved in its preparation have been shipped and distributed and their exact current status may be unknown. This is relevant in the allocation and / or reallocation of resources ( For example It offers potential advantages in terms of flexibility in scheduling operations (between equipment, equipment operators, and / or materials), while potentially increasing the certainty that work will not be repeated, interrupted, and / or excessively delayed.

[0110] Digital handshake is also a potentially reliable and low-maintenance indicator. Firstly, it does not require updating before drug preparation operations begin. Secondly, at least in... Figure 3A In some instances of operation, the digital handshake will not be skipped or missed in any way by any major component of the system. Without a digital handshake, the operator of the drug preparation device 210 does not have the information required to prepare the drug formulation. Furthermore, when said information is provided, both the control server 220 and the medical record system 230 are directly involved and are therefore accordingly notified that preparation has begun.

[0111] Scanning operation At box 305, in some instances, the operation begins with the operator positioning an identifier pattern to be read by the identification device 107. In some instances, the identifier pattern is optically scannable; optionally, it includes a printed label or sticker. The identifier pattern includes, for example, a barcode, QR code, and / or text. The identifier pattern barcode, QR code, text, and / or other signal type / data representation is set to and / or indicates an identifier for a prescription stored in an electronic medical record (EMR) system. Identifier pattern ( Right now (from which the identifier's signal and / or the physical configuration of the substance) and the identifier itself ( For example Data (determined from one or more identifier patterns) may be understood herein as “data indicating specified contents” including pharmaceutical preparations. In some instances, the functionality so indicated is optionally fully and / or partially pre-established. In some instances, the functionality so indicated is at least partially established as part of one or more communication operations; For exampleRandom numbers are optionally provided to the drug preparation apparatus 210 and associated with additional instructions obtained from the control server 220, while the control server 220 and / or the medical record system 230 record the associated additional connections. For example The drug preparation device 210 has no and cannot access the connection to the potential patient identification data.

[0112] As used in this article, the term "scanable" means that a pattern can be determined (read) through automatic sensing (inspection). Right now This does not refer to using scanning motion itself. It does not exclude the possibility of non-optical pattern reading. For example This involves using radio frequency devices, such as RFID chips. In this case, the scanned pattern includes... For example Time patterns of radio signals For example The bits in a transient signal are generated by a device configured to produce such a signal. However, optical pattern types have the potential advantages of low cost, ease of generation, and / or ease of use with readers.

[0113] In some instances, the operator issues a command to begin scanning via user interface 260. For example The operation can be initiated by pressing the "Scan" button on the touchscreen interface of the drug preparation device or by other means.

[0114] In some instances, at box 310: in response to an operator's command, the drug preparation apparatus 210 optionally sends a signal to the control server that the drug preparation apparatus identification device is ready to be activated. In response, at box 315, the control server 220 signals the drug preparation system 210 to control the identification device 107 to apply a label (or sticker). wait ( ) scan.

[0115] Boxes 310 to 315 represent optional "pre-handshake" phases of the operation. For example This ensures that communication is properly established and that the drug preparation device 210 and control server 220 can properly identify and / or authenticate each other. In an alternative implementation, a scan is simply transmitted at box 320. For example This is the result of the operation on box 320. In some instances, the initial scan of box 320 is omitted. For example Because the identifier itself is provided to the drug preparation apparatus 210 by the control server 220 after authentication; For example The digital form is provided and printed using a printer associated with the identification device 107 at the drug preparation apparatus 210. It should be noted that the printing and scanning methods are similar, at least in that they both involve physical tokens. example like about Figure 3B The described operation directly associates this physical token with the prepared pharmaceutical formulation.

[0116] Optionally, the control server 220 relays at least some of any remaining information related to the preparation of a specific drug formulation during this operational phase to the drug preparation apparatus 210. For example This is sufficient to allow selection of the work to be performed, to be executed at least partially at the local and drug preparation device 210 levels. For example, the control server 220 optionally provides the drug preparation device 210 with multiple job options, which the drug preparation device 210 and / or its operators optionally select based on resources available at the local work location. For example (Time and / or materials) can be selected from the job options.

[0117] In principle, the control server 220 can send the necessary data for generating a specific drug formulation. all Remaining information (and optionally, information on any of several such formulations available for processing for selection). This is not necessarily excluded. However, there is a potential advantage to initially retain at least some information; For example , as a provable procedure for maintaining the global state determinism within the entire system.

[0118] At box 320, in some instances, the identification device 107 optionally scans tag 80. It should be noted again that at this stage, tag 80 itself is not necessarily physically or digitally associated with details of the operation to be performed. For example, it may simply be printed as the next identifier number in a sequence. Alternatively, the identifier provided on tag 80 is pre-associated with a given patient and / or prescription and serves as a retrieval identifier for that particular patient and / or prescription.

[0119] As already mentioned, the data flow is optionally in the opposite direction, wherein the control server 220 and / or the medical record system 230 For example The identifier to be used is provided in a printable file format. In this case, appropriate communication and / or status synchronization optionally occur to determine that the drug preparation apparatus 210 is indeed capable of performing a certain drug preparation task. For example There are suitable consumables available for its use.

[0120] When using optical scanning, the drug preparation apparatus 210 itself optionally performs image processing on the scanned image to derive and / or confirm the identifier of the prescription dosage. For example(The identifier associated with identifier pattern 85). It is potentially advantageous for the drug preparation apparatus 210 to perform this process at least for itself; this helps ensure that the drug preparation apparatus 210 knows the identifier through a direct and local chain of operations linking the use of camera 140 to the calculation of the identifier. However, optionally, some or all of the processing for determining the identifier is performed on control server 220.

[0121] Optionally, the identifier includes numbers, text strings, or other data streams that uniquely and uniformly identify the fluid container 175 itself. For example (In cases where the identifier has been pre-assigned in this manner), it identifies the intended contents of the completed pharmaceutical preparation, and / or identifies the patient, facility and / or device operator, and / or associated with the patient, facility and / or device operator. Optionally, the identifier is incorporated into one or more aspects of the identifier pattern 85, said aspects of which no direct textual and / or numerical equivalent has been assigned. For example The identifier is derived from the relative spacing size and / or color of the marker elements on label 80.

[0122] In completion box 320, in some instances, the drug preparation apparatus 210 transmits the prescription dosage identifier to the control server 220.

[0123] In some instances at box 325: after the control server 220 receives the prescription dosage identifier (and / or other selection and / or capability information from the drug preparation device 210), the control server 220 requests prescription data from the electronic medical record system 230.

[0124] Optionally, the request in box 325 is executed concurrently with and / or after other operations (e.g., those described above). The request is optionally sufficiently specified by the identifier itself. Optionally, the request uses additional information identifying the patient, defining local drug preparation capabilities, and / or other relevant information sufficient to narrow down the current preparation options, such that the medical record system 230 can determine to grant access to one or more relevant records.

[0125] In some instances, the control server 220 stores cached data and communicates with the medical record system 230 to verify the cache, obtain a decryption key to grant access to the cache, and / or otherwise complete the requested information.

[0126] In some instances, at box 330, the electronic medical record system 230 returns prescription data (and / or other necessary information) to the control server 220.

[0127] Optionally, access granted by the medical record system 230 depends on a specific identifier that receives a given drug preparation. Optionally, access may be granted in a more general context. For example When the identifier is at least partially general in meaning ( For example When the prescription indicates the ingredients but not a specific prescription, the medical record system 230 optionally selects the prescription to be assigned to the identifier.

[0128] Optional ( Right now When the identifier in question has not yet been uniquely pre-assigned to a specific prescription, there is a negotiation process in which information about the current capabilities of (the drug preparation device 210) and / or the current prescription requirements (stored by the medical record system 230) is exchanged until a suitable candidate drug formulation is selected to reach a consensus.

[0129] It should be noted that, at least at this stage, the identifier discussed possesses the specific characteristic of being a "specification identifier," indicating the designated contents of the drug dosage. This characteristic may be fully associated with the method from the outset, or it may have been fully or partially acquired (in the context of the entire drug preparation system 200).

[0130] Prescription data includes, for example, the prescription name and dosage, and / or other information suitable for presentation on a user interface. In some instances, prescription data specifies a list of materials (…). For example Fluid containers, syringes, and components of drug compounds wait The operator of the drug preparation device 210 is instructed to place the material in the appropriate position in the drug preparation device 210 before the robot dose preparation.

[0131] At box 331, in some instances, the user interface 260 of the drug preparation apparatus 210 optionally performs basic verification of the received prescription data. For example Ensure that the dosage is non-zero and otherwise within reasonable constraints of quantity and / or safety. If validation of local competence to a particular prescription has not yet been performed, this may optionally be performed at box 331.

[0132] In box 340, in some instances, new prescription data is optionally provided to the operator; again, For example This is done by displaying it on the user interface 260.

[0133] For reference Figure 3B It illustrates the steps of an example event sequence for the preparation of a safety-enhanced robotic drug dose according to some examples of this disclosure.

[0134] In some instances, Figure 3B The operation completes the change of prescription status from "not prepared" to "prepared". Similarly, the operation includes a digital handshake, initiated by the drug preparation device 210. However, the control server 220 and the medical record system 230... Figure 3A The device will be notified during operation and will therefore become aware of any abnormalities in cases where the drug preparation device 210 is prevented from successfully performing its functions in operation.

[0135] At box 341, in some instances, the operator of the drug preparation apparatus 210 selects a prescription for preparation from the user interface 260 (optionally, more than one such prescription is provided). For example As Figure 3A The user interface 260 then optionally displays to the operator the specified materials to be placed in the drug preparation apparatus (the result of the operation). For example Fluid containers, syringes, and IV bags for specific medications wait The operator places these materials into the drug preparation apparatus 210. The drug preparation apparatus 210 optionally performs verification of the presence of any one or more of these components; For example Ensure that fluid container 175 is present, the label on the fluid container (other than label 80 itself) is correct, and / or syringe 156 is present.

[0136] In response to a successful verification at this stage, the drug preparation apparatus 210 optionally presents an instruction on the user interface 260, for example, by making a "Start" button available on a touchscreen interface display. In response, the operator manipulates the user interface 260 to indicate that robotic preparation should begin (e.g., by pressing the "Start" button on the touchscreen interface of the drug preparation apparatus). Optionally, verification of the setup itself is sufficient to automatically initiate drug preparation. In such cases, the operator actually initiates robotic preparation by placing the last specified element. However, the use of specific user commands offers the potential advantage of providing specific checkpoints that encourage human consideration of the overall configuration.

[0137] Optionally, the drug preparation apparatus 210 is configured, at least by default, to perform preparation without further human operator input. During this stage, one or more of the physical parameters affecting the preparation ( For example All pharmaceutical materials input for the preparation of the formulation can be considered "frozen" and remain unchanged for the remaining preparation. Optionally, the pharmaceutical preparation apparatus 210 continues to monitor the components set by the operation ( For example (Through continuous imaging) to confirm that it has not been altered or otherwise interfered with during subsequent operations to prepare the specified drug formulation. If human intervention occurs during the operation ( For example (to correct malfunctions and / or resupply one of the drug components), the drug preparation apparatus 210 optionally repeats Figures 3A to 5 The identifier exchange and / or verification of any suitable part, wherein the authorization and / or record of this operation is granted and / or stored as appropriate by the control server 220 and / or the medical record system 230.

[0138] At box 342, in some instances, the drug preparation apparatus 210 transmits an instruction for a "new order" to the control server 220 to prepare the drug as previously ordered. For example From the identifier pattern 85 of label 80 and / or in Figure 3A The drug dose associated with a dose-specific specification identifier determined otherwise during operation. Optionally, the dose-specific specification identifier ( For example ,exist Figure 3A The identifier scanned in the image is itself used as an "order number" or otherwise associated with it, and ultimately used as a "completion status identifier". Optionally, the completion status identifier and the specification identifier include different data. Alternatively, for example, in an instance where the sticker is scanned first (as the specification identifier) ​​and then attached to the receiving container (as the completion status identifier), the two identifiers are the same.

[0139] At box 343, in some instances, control server 220 determines the operational parameters of the prescription. These operational parameters may include specific attributes of prescription preparation and / or its preparation process, which are not necessarily available from the original prescription data. example like , such as in Figure 3A The operation parameters are shared during the process and / or as initially written. For example, the operation parameters may include the amount of fluid aspirated from the fluid container, which should then be injected into the IV bag. In some embodiments, the operation parameters may include additional data, such as specific preparation steps to be taken by the drug preparation device. For example (Injector volume verification), specific parameters to be used ( For example Syringe suction speed wait As a non-restricted instance, control server 220 determines job parameters from a local database.

[0140] At box 344, in some instances, control server 220 transmits operation parameters to drug preparation apparatus 210. It is not excluded that control server 220 previously ( For example ,exist Figure 3A During the operation and / or during a previous drug preparation session, some or all of the necessary information has been transmitted, wherein the data in box 344 is provided as confirmation of the data transaction, decryption key, cache pointer or other "completion".

[0141] In some instances, based on additional information ( For exampleThe operation of boxes 343 and / or 344 is gated (allowed or disallowed) by images and / or other repetitions in messages sent from the drug preparation apparatus 210, and the additional information asserts and / or confirms that the materials and the drug preparation apparatus 210 itself are in a state suitable for initiating drug preparation.

[0142] Similarly, it cannot be ruled out that the drug preparation device 210 may be optionally advanced ( For example ,exist Figure 3A The operation of the drug preparation device 210 (at or before the time of operation) receives any information it needs, wherein the operation of boxes 342 to 344 is largely limited to the exchange of messages between the drug preparation device 210 and the control server 220 indicating that drug preparation can be and has then started.

[0143] However, a potential advantage for drug preparation information available to the drug preparation apparatus 210 is that it remains at least partially incomplete, inaccessible, and / or unavailable until the control server 220 “gate” the start of the preparation operation itself by providing this information to the drug preparation apparatus 210. For example, this helps to provide an inherent guarantee that the use of materials is recorded, and that the use of materials occurs when and how it is indicated in the definitive record ultimately stored in the medical record system 230.

[0144] In this respect, it can be asserted that, under normal circumstances, preparation "cannot begin" until the control server 220 itself provides the final information required for the preparation of the drug formulation. Such assertions are potentially useful in demonstrating proper control of the process. For example For regulatory and / or quality assurance purposes. The validity of the assertion may optionally be strengthened by other methods. example like Facility monitoring and control. Furthermore, if the normal operation of the drug preparation apparatus 210 relies on the latest data sent from the control server 220, then there may be correspondingly greater confidence and / or more robust document tracking demonstrating that the correct preparation instructions are actually applied to the materials queued for use in the drug preparation apparatus 210.

[0145] Control server 220 optionally possesses capabilities for verification and / or validation, exceeding the capabilities of the drug preparation apparatus 210 itself, and / or centralizing those capabilities. Centralizing such capabilities in control server 220 potentially simplifies program security and / or updates. For example, drug preparation apparatus 210 optionally sends data to control server 220 in the form of images, timestamps, and / or sensor data. Control server 220 optionally performs any suitable additional checks, which may be automated and / or involve remote human supervision.

[0146] At box 345, in some instances, the drug preparation apparatus 210 performs robotic drug preparation steps based on received operating parameters. However, in some instances, the finished drug formulation remains locked into the drug preparation apparatus 210 at this stage. For example (Locked by container lock 180 and / or another mechanism having drug preparation device 210).

[0147] At box 350, in some instances... For example After successfully completing the robotic drug preparation step, the operator and / or the drug preparation device 210 itself will exchange and / or agree upon a completion status identifier with the rest of the drug preparation system 200. For example ,exist Figure 3A The identifiers scanned and / or printed during the operation are associated with the preparation dose physics.

[0148] For example, the operator and / or drug preparation device 210 places labels and / or stickers on the prepared syringes, IV bags, and / or vials. As described above, a potential advantage of involving a human operator in the labeling process is that it ensures "human involvement." For instance, a human operator placing the label proves their actual presence and participation in the drug preparation process. Furthermore, this individual is positioned to understand the overall condition of the drug preparation device 210 and / or the facility on which it operates. This has potential benefits for risk management and / or meeting regulatory concerns.

[0149] In some instances, the operator manipulates the user interface 260 to indicate that the robotic preparation is complete (e.g., by pressing the "Complete" button on the touchscreen interface of the drug preparation device 210).

[0150] At box 355, in some instances, the drug preparation apparatus 210 sends a signal to the control server 220 indicating that dose preparation is complete. At box 360, in some instances, the control server then signals the drug preparation apparatus to capture an image of the prepared dose or otherwise reads the completion status identifier attached to it.

[0151] In the case of an optical reader, the drug preparation apparatus 210 can then ( For example The drug preparation apparatus 210 uses a camera 140 to capture an image of the dose. Optionally, the drug preparation apparatus 210 performs image processing on the captured image to determine a completion status identifier for the prescribed dose. Alternatively, this task is performed by a control server 220. Optically, another form of dose / identifier association evidence is generated. For example, an RFID tag is optionally read using a reading located in appropriate physical proximity to the prepared dose; proximity itself is optionally ensured by physical constraints, imaging, and / or other means of verification.

[0152] At box 365, in some instances, and assuming that the completion status identifier now read appropriately matches the expected identifier ( For example If the initially scanned and / or printed identifier (and / or otherwise defined completion status identifier) ​​is used, the drug preparation device performs an unlocking operation to allow the dose to be removed from the drug preparation device. The "expected" status should be understood as including a suitable association between the nominal completion status identifier and the specified contents of the prepared drug dose. In some instances, this association is established through conformity and / or comparison with the specification identifier. In some instances, this association is established through derivation from the specification identifier. In some instances, this association is established by linking the specification identifier and the completion status identifier through a data structure such as a database table or other data record.

[0153] If the completion status identifier does not match the expected one (or if there is no identifier on the dose), the drug preparation device may require the operator to place the correct identifier on the dose before the drug preparation in fluid container 175 can be removed from drug preparation device 210, and / or optionally accept bypassing container lock 180 (optionally with one or more consequences, such as invalid prepared dose).

[0154] At box 370, in some instances, the drug preparation apparatus 210 transmits a notification of successful dose preparation verification to the control server 220. The drug preparation apparatus 210 optionally includes documentation of the preparation (…). For example Images of different stages of preparation) and notifications; optionally, some of these are provided during the preparation process itself. For example When it is recorded.

[0155] In box 375, in some instances, control server 220 signals electronic medical record system 230 to update the status of prescriptions.

[0156] For reference Figure 4 The flowchart illustrates an example method for preparing a drug dosage safety-enhanced robot according to some examples of this disclosure.

[0157] In some instances, Figure 4 The method employs a security-enhanced and privacy-enhanced architecture, in which access to electronic medical records and sensitive patient data is restricted to control server 220 and / or medical record system 230. In addition to selecting the information required for proper recording from medical record system 230, control server 220 itself optionally avoids using most or all of the sensitive identification information.

[0158] also, For example And also regarding Figure 3B As described, the drug preparation device 210 is configured to retain the prepared dose until the operator has properly labeled its contents.

[0159] At box 405, in some instances, the processing circuitry (e.g., identification device 107) scans the identifier indicating the drug dosage. Right now The code (specification identifier). The code can be, for example, a barcode, a QR code, or text that can be read by optical character recognition (OCR). wait The code can be found in labels, stickers, and text printed on paper. wait Read. In some instances, the code can be retrieved from a radio frequency identification (RFID) tag. wait Read.

[0160] about Figures 3A to 3B The described printed (and optionally non-scanned) example ( For example The operation of box 405 is optionally applied to the printing of an identifier provided by control server 220. With regard to control server 220 recording that it has provided 210 with a suitable identifier for printing, it optionally accepts this identifier (e.g., on the print media) as it will later be available as a completion status identifier. However, optionally, control server 220 requests the return transmission of the identifier; For example As an additional precaution.

[0161] The processing circuit system 215C can utilize the identification device 107 or another suitable identification device (camera 140, RFID reader). wait The identification device 107 or another suitable identification device itself provides the identifier to the processing circuitry system 215C. In some other embodiments, the processing circuitry system 215C and / or 215B (of the control server 220) performs image processing and / or other suitable processing to scan the code of the identifier indicating the drug dosage. For example Export identifier from the scanned image of the label.

[0162] In some instances, the processing circuitry system scans a QR code from a fluid container tag, the QR code being prepared based on information from an electronic medical record system. For example (The information is assigned to represent it). In this way, the system can generate prescription requests based on electronic medical record data without requiring access to the electronic medical record itself. For example, the association between the specification identifier and personal medical data is maintained in a location other than the drug preparation device 210 itself.

[0163] In some instances, at box 410, the processing circuit system 215 and / or the identification device 107 transmits the specification identifier of the drug dosage directly to the control server 220. For example, via communication link.

[0164] At box 415, in some instances, the processing circuitry (e.g., identification device 107) can then ( For example The system receives data from the control server 220 indicating specified contents for a drug dosage. This data may include, for example, the prescription name and dosage, as well as other information optionally suitable for presentation on a user interface. The data may further include a list of materials (…). For example Fluid containers, syringes, pharmaceuticals wait The operator must place the material in the appropriate position on the drug preparation device before the robot prepares the dose.

[0165] It should be noted that in some instances, and prior to the robot's preparation of the prescription, the processing circuitry (e.g., hardware control unit 245C) optionally transmits additional messages to the control server 220, which request the initiation of new preparation jobs and / or the receipt of additional information regarding the preparation of the prescription. For example As described above, refer to Figures 3A to 3B .

[0166] At box 420, in some instances, the processing circuitry (e.g., hardware control unit 245C) locks the fluid container holding the final dose into the machine. For example Using container lock 180, the execution of the robot sequence is initiated to prepare the dose. It should be noted that the locking of the fluid container can occur before or during the robot sequence for dose preparation, and the container locking can be in response to instructions from the control server 220.

[0167] At box 425, in some instances, the processing circuitry 215C and / or the identification device 107 captures an image of the drug dosage. By way of a non-limiting example: For example The processing circuit system 215C and / or the identification device 107 may themselves use the drug preparation device camera 140, which is also used to monitor the prescription preparation process.

[0168] It should be noted that in some embodiments, this imaging of the dose may be in response to instructions from control server 220, as referenced above. Figures 3A to 3B As described.

[0169] The processing circuit system 215C and / or identification device 107 will next determine ( For example The presence of a dose identifier in the captured image (using imaging techniques) and whether the determined dose identifier (nominally expected to be a completion status identifier) ​​adequately matches the dose identifier of the original scan (i.e., the specification identifier).

[0170] In some instances, the processing circuitry 215C and / or the identification device 107 process barcodes and QR codes. wait To determine the dose identifier. In some instances, the processing circuitry 215C and / or the identification device 107 may use a scanner, RFID reader, etc. wait To determine the dose identifier. Optionally ( For example (as a supplement and / or alternative to imaging) in determining For example A scan is performed under conditions where a certain RFID identifier is physically associated with the dose being prepared. For example, the RFID scanner is built into the drug preparation apparatus 210 at a location adjacent to the locking position of the fluid container 175.

[0171] At box 430, in some instances: if the determined dose identifier matches the dose identifier of the original scan (i.e., if the nominal completion status identifier is properly linked to the specification identifier), then the processing circuitry (e.g., hardware control unit 245C) unlocks the fluid container 175 containing the final prepared dose of the drug, thereby releasing it from the drug preparation apparatus. If the determined dose identifier does not match the dose identifier of the original scan, then the processing circuitry (e.g., hardware control unit 245C) may maintain the dose locked until the correct label is applied to the dose. In this way, the drug preparation apparatus ensures that the dose is properly labeled—even if the specification of its contents originates remotely. Optionally, intentional bypassing of container lock 180 is explicitly supported. Optionally, intentional bypassing of container lock 180 results in and / or requires rendering and / or labeling fluid container 175 unusable; For example Apply "Do Not Use" stickers, damage fluid container 175, and / or discharge the contents of fluid container 175 into the waste containment tank.

[0172] Finally, the processing circuitry 215 and / or identification device 107 send a notification and / or evidence of completion of dose preparation and process documentation to the control server 220. The control server 220 then optionally notifies the medical record system 230 of the new status of the drug preparation. In this way, the drug preparation device 210 can indirectly update the electronic medical record system 230 after dose preparation, without needing to access the electronic medical record system at the dose preparation location (and the resulting privacy and regulatory issues).

[0173] For reference Figure 5 The flowchart illustrates an example method for preparing a drug dosage safety-enhanced robot according to some examples of this disclosure.

[0174] In some instances, Figure 5 The method shown uses a safety enhancement approach, in which the drug preparation device 210 retains the prepared dose until the operator properly labels its contents. Figure 5 The methods shown herein can optionally prepare a prescription without communicating with an external server. Alternatively, communication may occur, but only to obtain the information needed to prepare the dosage itself without having any other systematic effect on the representation of the dosage state; For example The preparation status will not be updated immediately.

[0175] At box 505, in some instances, the processing circuitry (e.g., including and / or operation identification device 107) scans an identifier (specification identifier) ​​indicating the dosage of the specified contents to be prepared. The identifier optionally includes, for example, a barcode, a QR code, or text readable by optical character recognition (OCR). wait Identifiers may be selected from labels, stickers, or text printed on paper. wait Reading. In some instances, the identifier is read from a radio frequency identification (RFID) tag. The specification identifier optionally includes directly descriptive information. For example Name the dosage components, quantities, and / or preparation instructions. In some instances, the specification identifier contains information that is at least partially extracted from the direct description of the contents; For example The encoding of Uniform Resource Locators (URLs), Uniform Resource Indicators (URLs), database keys, and / or content specifications. Optionally, the storage and / or interpretation details of indirectly referenced information are implicit in the processing circuitry. Optionally, the indirectly referenced information is self-descriptive. For example As long as its naming follows a well-known pattern, network address, and / or uses another well-known encoding and / or addressing protocol.

[0176] In some embodiments, the identification device 107 or another suitable identification device provides data to the processing circuitry system 215C. In some embodiments, the processing circuitry system 215C performs image processing and / or other suitable processing to obtain data from the image processing device. For example Export data from the scanned image of the label.

[0177] Data on specified contents indicating drug dosage directly and / or indirectly includes, for example, the name of the prescription, dosage, and other information optionally suitable for presentation on a user interface. The data may optionally further include a list of materials (…). For example Fluid containers, pharmaceuticals, syringes wait The operator must place the material in the appropriate position on the drug preparation device before the robot prepares the dose.

[0178] At box 510, in some instances, the processing circuitry (e.g., hardware control unit 245C) will then... example likeLock the fluid container holding the final dose into the machine (e.g., using container lock 180). Initiate the robotic sequence to prepare the dose. Note that locking of the fluid container can occur before or during the robotic sequence for dose preparation.

[0179] At box 515, in some instances: after the sequence is complete, the processing circuitry 215C captures an image of the drug dosage ( For example (Using camera 140 and / or identification device 107). By means of a non-limiting example: the processing circuit system 215 optionally uses the drug preparation device camera 140, which is also used to monitor the prescription preparation process.

[0180] The next step in determining the processing circuit system 215C is ( For example The determination of whether a dose identifier (nominally a completion status identifier) ​​prepared using imaging technology exists in the captured image of the dose (and / or other identification data), and whether the determined prepared dose identifier matches the dose identifier (specification identifier) ​​of the original scan (optionally after appropriate transformation and / or link search). For example, the processing circuit system 215C, camera 140, camera controller 130, and / or identification device 107 can process the imaged barcode, QR code, etc. wait To determine the dose identifier. In some instances, the processing circuitry system 215* uses an RFID reader or other non-imaging device to determine the dose identifier.

[0181] At box 520, in some instances: if the determined dose identifier appropriately matches the initially sensed dose identifier, then the processing circuitry (e.g., hardware control unit 245C) unlocks the fluid container 175 containing the final prepared dose of drug. For example By unlocking container lock 180, fluid container 175 is released from drug preparation device 210. If the determined dose identifier does not properly match the dose identifier of the original scan, the processing circuitry system (e.g., hardware control unit 245C) can maintain dose lock until the correct label is applied to the dose and the dose is rejected. For example (If the lock is bypassed to allow the resumption of drug formulation preparation), or another corrective measure is taken.

[0182] It should be understood that "matching" does not necessarily require data consistency; the term here means that a nominal completion status identifier (also known as a dose identifier) ​​physically attached to a completed drug dose is found to appropriately match the specification identifier of the original data providing the specified contents indicating the drug dose. Optionally, the specific contents of the drug dose itself are the object of the match.

[0183] In some embodiments, the identifier portion (which may be arbitrary in value and / or whose direct meaning is opaque) is provided both as part of the original sensed dose identifier and as a matching component of the dose identifier. In some instances, the identifier portion is functionally defined within the operating environment of the drug preparation apparatus 210 and / or the drug dispensing system to which it belongs. For example (Unique). Optionally, the dose identifier is derived from the original data indicating the specified content using a hash function, and / or the original data indicating the specified content is otherwise transformed. Optionally, the transformation may result in the loss of information ( For example (Information may be shuffled or removed), but sufficient connections are preserved so that a suitable matching operation can detect the connections.

[0184] Figure 5 Although server communication is omitted internally, the operation optionally involves originating from and / or ultimately reporting back to the remote database. For example One or more identifiers of a centralized server computer are used in conjunction with the execution. Although in principle more scenarios that could lead to skewness may be permitted ( For example ,and Figure 4 Compared to other methods, it still optionally does not transmit personally identifiable information; For example The specification identifier itself is optionally specified ( For example (As is customary) and / or linked to the full specifications of the associated pharmaceutical preparation, without necessarily providing additional links to identification information. The completion status identifier applied to the pharmaceutical preparation itself may optionally contain less information and may be completely abstract except for implementing the matching calculation.

[0185] Furthermore, in this example, the "lock until labeling" functionality also offers the potential advantage of linking an earlier selection (e.g., a specification identifier that forms the basis for performing the preparation operation) to a final, physically associated completion status identifier, which takes the form of a tag, RFID device, or other physical token attached to the fluid container 175 containing the completed pharmaceutical preparation.

[0186] For reference Figure 6 The illustration shows an example IV bag 602 with a label 80 containing a barcode 601, according to some examples of the present disclosure. The IV bag 602 is an example of a fluid container 175, and the barcode 601 is an example of an identifier pattern 85.

[0187] Following monitored and / or gated prescription preparation procedures For example , such as regarding Figures 3A to 5 As described, the fluid container 175 (e.g., IV bag 602) released from the drug preparation device 210 is subsequently automatically linked to verification evidence ( For example(This is associated with the medical record system 230) to prove that drug preparation has been performed as specified.

[0188] General situation As used in this article, the term “about” in relation to quantity or value means “within ±10% of”.

[0189] The terms “comprises,” “comprising,” “includes,” “including,” “having,” and their enumerated variants mean: “including but not limited to.”

[0190] The term "composed of" means "contains and is limited to".

[0191] The term "consistently made up of" means that a composition, method, or structure may contain additional ingredients, steps, and / or portions, provided that the additional ingredients, steps, and / or portions do not substantially alter the fundamental and novel characteristics of the claimed composition, method, or structure.

[0192] As used herein, unless the context clearly indicates otherwise, the singular forms “a / an” and “the” contain plural indicators. For example, the terms “compound” or “at least one compound” may include multiple compounds, including mixtures thereof.

[0193] The terms “example” and “exemplary” are used herein to mean “serving as an example, illustration, or description.” Any embodiment described as an “example” or “exemplary” is not necessarily to be construed as superior to or superseding other embodiments and / or as excluding the incorporation of features of other embodiments.

[0194] The term “optionally” is used herein to mean “provided in some embodiments and not in others”. Any particular embodiment of this disclosure may include multiple “optional” features, except where such features conflict to some extent.

[0195] As used herein, the term “method” means, means, techniques and procedures for accomplishing a given task, including but not limited to those known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine, or those that are readily developed based on known means, means, techniques and procedures.

[0196] As used herein, the term “treatment” includes eliminating, substantially inhibiting, slowing or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the occurrence of the clinical or aesthetic symptoms of a condition.

[0197] Throughout this application, embodiments may be presented in a range format. It should be understood that the use of a range format is for convenience and brevity only and should not be construed as a rigid limitation on the scope of this disclosure. Therefore, the description of a range should be considered as specifically disclosing all possible subranges and individual numerical values ​​within those ranges. For example, a description of a range such as "1 to 6" should be considered as specifically disclosing, for example, "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6". wait Subranges; and individual numbers within the range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

[0198] Whenever a range of numbers is indicated herein (e.g., “10-15”, “10 to 15”, or any pair of numbers connected by such range indications), it means any number (fraction or integer) contained within the indicated range boundaries, including the range boundaries, unless the context explicitly states otherwise. The phrases “range” / “ranging” / “ranges” between the first and second indicating numbers, and “to”, “at most”, “until”, or “through” (or another such range indication term) for the second indicating number, are used interchangeably herein and mean including the first and second indicating numbers and all fractions and integers in between.

[0199] Although the description of this disclosure has been provided in conjunction with specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to cover all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0200] It should be understood that, for clarity, certain features described in the context of individual embodiments in this disclosure may also be provided in combination in a single embodiment. Conversely, for simplicity, various features described in the context of a single embodiment may also be provided individually or in any suitable sub-combination or, where appropriate, in any other described embodiment of this disclosure. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments unless the embodiments would not function without those elements.

[0201] The applicant intends that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety as if each individual publication, patent, or patent application were specifically and separately cited as being incorporated herein by reference. Furthermore, any reference or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art as disclosed herein. The use of section headings shall not be construed as necessarily restrictive. Additionally, any priority documents of this application are hereby incorporated herein by reference in their entirety.

Claims

1. A safety-enhanced drug preparation apparatus configured to exchange contents between one or more containers to prepare a drug dose provided in a receiving container, the apparatus comprising: One or more identification devices capable of sensing identifier patterns; Container lock; as well as A processing circuit system and a memory, the memory containing instructions to configure the processing circuit system to perform the following operations: The specification data of a specified content indicating a drug dosage is obtained using the one or more identification devices. The receiving container is locked into the drug preparation apparatus using the container lock. The drug preparation apparatus is controlled to prepare the drug dosage. In response to completion of preparation, the one or more identification devices are operated to obtain completion status identification data that identifies the receiving container containing the dose of the prepared drug. Determine the specified contents of the drug dosage indicated by the completion status identification data, and The container lock is unlocked according to the determination.

2. The apparatus of claim 1, wherein the processing circuitry determines the specified contents of the drug dosage indicated by the completion status identification data by comparing the completion status identification data with the specification data.

3. The apparatus of claim 2, wherein the comparison check verifies the consistency between the completion status identification data and the specification data.

4. The apparatus according to any one of claims 1 to 3, wherein the drug preparation apparatus comprises one or more robotic fluid transfer actuators, and the processing circuitry system controls the robotic fluid transfer actuators such that the receiving container contains the drug dose after preparation is completed.

5. The apparatus according to any one of claims 1 to 4, wherein the one or more identification devices are positioned to image a carrier attached to a locked receiving container to obtain the completion status identification data.

6. The apparatus of claim 5, wherein the one or more identification devices are configured to image the specification data from the carrier prior to the receiving container being locked into the drug preparation apparatus.

7. The apparatus of claim 6, wherein the carrier is a sticker, the sticker being transferred to the receiving container after the processing circuitry obtains the specification data to provide the completion status identification data.

8. The apparatus of claim 1, wherein the one or more identification devices include at least one optical camera, and the identification data includes at least one image obtained using the optical camera.

9. The apparatus of claim 8, wherein the processing circuitry uses image processing to determine the designated contents indicative of the drug dosage by the identification data.

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

11. The apparatus according to any one of claims 1 to 10, wherein the container lock comprises one or more robotic fluid transfer actuators, the one or more robotic fluid transfer actuators being positioned to prevent the receiving container from being removed from the drug preparation apparatus when the container lock is locked.

12. The apparatus according to any one of claims 1 to 11, wherein: The container lock includes a bypass option that can be used to unlock the receiving container before the processing circuitry determines that the identification data indicates the specified contents of the drug dose; and The operation of the bypass option causes the bypass operation indicator to be placed on the receiving container.

13. The apparatus of claim 1, wherein the processing circuitry is further configured to: The specification data is obtained as a specification identifier for the drug dosage; Transmit the specification identifier to the control server; In response to the identifier, data specifying the drug dosage of the contents is received from the control server; as well as The indication that drug preparation has been successfully completed is transmitted to the control server; The data received specifying the dosage of the drug is exchanged for the specification identifier to prevent the drug preparation device from accessing personally identifiable electronic medical records.

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

15. The apparatus according to any one of claims 13 to 14, wherein the data indicating the specified contents of the drug dosage includes an identifier received from a control server.

16. The apparatus of any one of claims 13 to 15, wherein the data indicating a specified content of a drug dosage includes an identifier provided to the control server, the identifier at least partially specifying the current capability of the drug preparation apparatus.

17. The apparatus according to any one of claims 13 to 16, wherein the identification data includes a label printed based on data received from the control server.

18. The apparatus according to any one of claims 1 to 13, wherein the data indicating the specified content of the drug dosage includes scanning of a label, the label including at least one of: a barcode, a QR code, and identifier text.

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

20. The apparatus according to any one of claims 18 to 19, wherein the tag further serves as the identification data obtained in response to completion of preparation.

21. The apparatus according to any one of claims 1 to 18, wherein the processing circuitry is configured to lock the receiving container prior to initiating drug preparation.

22. The apparatus according to any one of claims 1 to 18, wherein the processing circuitry is configured to lock the receiving container after initiating drug preparation.

23. A method for controlling the release of a pharmaceutical preparation automatically prepared by a pharmaceutical preparation apparatus, said pharmaceutical preparation apparatus being configured to exchange contents between one or more containers to prepare a dose of the pharmaceutical preparation in a receiving container; The method is performed by the drug preparation apparatus and includes: Obtain specification data for the designated contents that indicate the dosage of the drug; Lock the receiving container into the drug preparation device; Control the drug preparation apparatus to prepare the drug dosage; In response to completion of preparation, one or more identification devices are operated to obtain completion status identification data for the receiving container containing the dose of the prepared drug; The completion status identification data indicates the specified contents of the drug dosage; and The container lock is unlocked as described above.

24. The method of claim 23, wherein the specification data and the completion status identification data are both obtained from corresponding images of the same label, and the image of the completion status identification data is obtained while the receiving container remains locked in the drug preparation apparatus.

25. The method according to any one of claims 23 to 24, comprising: The specification data is obtained as a specification identifier for the drug dosage; Transmit the specification identifier to the control server; In response to the specification identifier, data specifying the drug dosage of the contents is received from the control server; as well as The indication that the drug preparation sequence has been successfully completed is transmitted to the control server; The data received specifying the dosage of the drug is exchanged for the specification identifier to prevent the drug preparation device from accessing personally identifiable electronic medical records.

Images