System and method for distributed ledger management of nuclear medicine products

Abstract

Systems and methods for tracking and managing a distributed ledger containing information about batches of radiopharmaceutical material are disclosed. Some examples provide a computer-implemented method for managing radiopharmaceutical material, the method including: using at least one processor to track the status of the batches of radiopharmaceutical material, the status including a type, quantity, and timestamp associated with the batches of radiopharmaceutical material; generating a record in a first copy of the distributed ledger using the type, quantity, and timestamp associated with the batches of radiopharmaceutical material; updating the record based on at least one of usage of the batches of radiopharmaceutical material, resale of at least a portion of the batches of radiopharmaceutical material, and decay of the batches of radiopharmaceutical material; and sharing the record with a second copy of the distributed ledger.

Description

Technical Field

[0001] The present disclosure generally relates to improved nuclear medicine, and more particularly to improved systems and methods for distributed ledger management of nuclear medicine products.

Background Art

[0002] Nuclear medicine involves radioactive substances to highlight aspects of a patient's anatomical structure in the resulting images. Such radioactive substances are expensive to produce, potentially dangerous, and decay rapidly. As a result, the composition, production, storage, and use of radioactive substances are highly regulated, controlled, and have a limited effective shelf life. Given strict control and rapid decay, substances often become unusable due to delays in logistics and / or lack of communication. Further, once the substances are produced and distributed, the provider loses visibility into the status of the substances, their use, etc. This results in, for example, waste, uncertainty, and potential safety hazards. Also, the value of any batch of a nuclear medicine tracer is directly related to its activity.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Thus, it is desirable for producers and users to have timely information about the activities in the process of ordering, distributing, and using these substances.

Means for Solving the Problems

[0004] Some examples provide systems and methods for tracking and managing a distributed ledger containing information about batches of radiopharmaceutical substances.

[0005] Some examples provide a distribution monitoring processor device including data storage for storing instructions for execution and a first copy of a distributed ledger, a data communication interface for receiving and transmitting data, a substance status monitor for tracking the status of a batch of radiopharmaceutical substances, the substance status monitor receiving, via the data communication interface, indications of a type, an amount, and a timestamp associated with the batch of radiopharmaceutical substances, and a ledger record processor for generating and updating records in the first copy of the distributed ledger using the indications of the type, the amount, and the timestamp associated with the batch of radiopharmaceutical substances from the substance status monitor, the ledger record processor adding transactions to the records to track how much of the batch of radiopharmaceutical substances is sold and resold.

[0006] Some examples provide a computer-readable storage medium including instructions that, when executed, cause at least one processor to at least track the status of a batch of radiopharmaceutical substances, the status including a type, an amount, and a timestamp associated with the batch of radiopharmaceutical substances, generate a record in a first copy of a distributed ledger using the type, the amount, and the timestamp associated with the batch of radiopharmaceutical substances, update the record based on at least one of use of the batch of radiopharmaceutical substances, resale of at least a portion of the batch of radiopharmaceutical substances, and decay of the batch of radiopharmaceutical substances, and share records having a second copy of the distributed ledger.

[0007] Some examples provide computer-implemented methods for managing radiopharmaceutical substances. Exemplary methods include using at least one processor to track the status of a batch of radiopharmaceutical substances, where the status includes the type, quantity, and timestamp associated with the batch of radiopharmaceutical substances. Exemplary methods include using at least one processor to generate a record in a first copy of a distributed ledger using the type, quantity, and timestamp associated with the batch of radiopharmaceutical substances. Exemplary methods include using at least one processor to update the record based on at least one of the use of the batch of radiopharmaceutical substances, the resale of at least a portion of the batch of radiopharmaceutical substances, and the decay of the batch of radiopharmaceutical substances. Exemplary methods include using at least one processor to share a record having a second copy of the distributed ledger.

Brief Description of the Drawings

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[0009] The drawings are not to scale. The same reference numbers are used throughout the drawings and the accompanying description to refer to the same or similar parts as much as possible.

[0010] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof, and in which are shown by way of illustration specific examples in which the subject matter may be practiced. These examples are described in sufficient detail to enable those skilled in the art to practice the subject matter, it being understood that other examples may be used and that logical, mechanical, electrical, and other changes may be made without departing from the scope of the subject matter of the present disclosure. The following detailed description is, therefore, given to describe exemplary implementations and should not be taken as limiting the scope of the subject matter described in the present disclosure. Some features from different aspects of the following description may be combined to form further new aspects of the subject matter discussed below.

[0011] When introducing elements of various embodiments of the present disclosure, the articles "a", "an", "the", and "said" are intended to mean that one or more of the elements exist. The terms "comprising", "including", and "having" are intended to be inclusive and mean that there may be additional elements other than the recited elements.

[0012] As used herein, the terms "radiocontrast", "radiopharmaceutical", and "radioisotope" are used interchangeably.

[0013] For some examples, they are described below in the context of a medical or healthcare system, although other examples may be implemented outside the medical environment. For example, some examples may be applicable to the handling of non-medical radioactive substances and the like.

[0014] I. Summary Nuclear imaging Nuclear medicine imaging uses a small amount of a radioactive substance (e.g., a radioactive tracer or radiopharmaceutical) that emits gamma rays that can be injected, inhaled, or ingested into the bloodstream of a target and detected by an imaging camera (e.g., a gamma camera) connected to a computer to form an image of the target. Nuclear medicine images provide unique information that often cannot be obtained using other imaging procedures and offer the possibility of identifying diseases at their earliest stages.

[0015] Positron emission tomography (PET) imaging is a nuclear medicine examination that uses a small amount of a radioactive agent to show differences between healthy and diseased tissues and form a three-dimensional (3D) image of the functional processes within a target's body. Single photon emission computed tomography (SPECT) is a nuclear medicine tomography technique that uses gamma rays and a gamma camera to capture target image data and form a 3D image.

[0016] PET and SPECT imaging systems are increasingly being used for the detection of diseases and are useful for the early detection and definitive diagnosis of such diseases (e.g., disease states in oncology, cardiology, and neurology). For example, currently, most PET and SPECT tests are related to cancer detection, myocardial perfusion assessment, and early Alzheimer's detection. These diseases require early diagnosis to enable timely and effective treatment.

[0017] PET and SPECT imaging systems each create images based on the distribution of positron-emitting isotopes and gamma-emitting isotopes in a patient's tissue. The isotopes are typically administered to the patient by injection of a radiopharmaceutical that contains a positron-emitting isotope, such as a probe molecule having carbon-11, nitrogen-13, oxygen-15, or fluorine-18, or a gamma-radiating isotope, such as technetium-99 or iodine-123. The radiopharmaceutical is readily metabolized, localized within the body, or chemically binds to receptor sites in the body. When the radiopharmaceutical localizes at the desired site (e.g., chemically binds to a receptor site), a PET or SPECT image is generated.

[0018] Systems such as GE's FASTlab™ and FASTlab™ 2, Drytec™ generators, etc., can be used to make radiotracer substances for use in PET, SPECT, and / or other nuclear imaging. Systems such as FASTlab™ use an automated cassette-based system that contains pre-measured amounts of chemicals involved in radiopharmaceutical synthesis to accept reactions that produce radiotracer substances (e.g., [18F]fluorometaol, etc.) over multiple runs. Some examples integrate reagents to enable the performance of multiple runs in the same hot cell (e.g., using fludeoxyglucose (FDG) citrate, etc.). Solid phase extraction, high performance liquid chromatography, etc., can be used to purify the synthesized radiotracer substance.

[0019] Other examples of radiopharmaceuticals include 18F-FLT ([18F]fluorothymidine), 18F-FDDNP (2-(1-{6-[(2-[18F]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile), 18F-FHBG (9-[4-[18F]fluoro-3-(hydroxymethyl)butyl]guanine or [18F]-penciclovir), 18F-FESP ([18F]-fluoroethylspiperone), 18F-p-MPPF (4-(2-methoxyphenyl)-1-[2-(N-2-pyridinyl)-p-[18F]fluorobenzamide]ethylpiperazine) and 18F-FDG ([18F]-2-deoxy-2-fluoro-D-glucose).

[0020] The radioisotope in a radiopharmaceutical is an isotope that exhibits radioactive decay, for example, an isotope that emits positrons. Such isotopes are commonly referred to as radioisotopes or radionuclides. Exemplary radioisotopes include 18F, 124I, 11C, 13N and 15O, which have half-lives of 110 minutes, 4.2 days, 20 minutes, 10 minutes, and 2 minutes, respectively.

[0021] PET radiotracers are often produced at a central facility and then distributed to other hospitals or imaging facilities where the tracer will be used. It is important to schedule patient examinations and PET tracer production to ensure that sufficient activity is available while the patient is undergoing the imaging examination. Often, the manufacturer (e.g., a PET center) and the user (e.g., an imaging facility) are different entities, and difficult logistics are involved, including time-constrained transactions for selling and buying the decaying substance, for example, related to the decaying activity.

[0022] Since radioactive isotopes have very short half-lives, the synthesis, purification, storage, transportation, and use of the corresponding radiopharmaceuticals must be rapid. For example, many of these processes, such as synthesis, purification, and quality control evaluation, should be completed in time to match the half-life of the radioactive isotope in the radiopharmaceutical. Therefore, the time involved in synthesizing, processing, and handling radioactive isotopes can be a bottleneck for the effective use of radioactive isotopes in nuclear medicine imaging for patient diagnosis in order to advance patient treatment.

[0023] Other radioactive isotopes are supplied using generators. For example, the supply of Tc-99m may be formed using GE's Drytec™ generator. The generator is shipped from a manufacturing facility containing a specific amount of activity. The generator is supplied nationwide, for example, on a weekly basis. Due to the high cost of the material, the generator is generally returned to the manufacturer for reuse after the supplied activity has decayed.

[0024] The end user must pre-reserve the generator and cannot specially purchase additional generators outside of the distribution and collection schedule. The end user also cannot store unused activity beyond the decay time and beyond the time the generator is at the user's facility. Therefore, the user is billed for the entire amount of the material, but any unused activity is wasted.

[0025] Previously, there was no systematic mechanism to enable the trading of surplus generator activities between two end-users whose bases could be near each other. For example, there was no communication mechanism for one user to disclose that, during a given period, they were not using the generator more frequently than planned, while another user needed additional activities due to a busier patient schedule or the like. Thus, if two users could exchange generators, the activities that might have been used would be unnecessarily lost. Also, some patient tests may not be performed when needed due to the unavailability of, for example, Tc-99m activity.

[0026] Distributed ledger A blockchain is a list of records or blocks that become linked to track the history of transactions and / or other evolutions of information. The blocks in a blockchain provide a history of transactions and / or other information states. A blockchain can be public (e.g., readable by anyone) or private (e.g., encrypted to be read only by those with a key). A blockchain and / or other distributed ledger technology can be used as a digital tool to manage physical assets traded among many entities. Blockchains and other distributed ledgers provide technical advantages including, for example, transparency and traceability in asset tracking and enabling transactions.

[0027] Blockchain technology is a distributed computing mechanism designed to provide a certain degree of fairness such that one entity does not gain an advantageous position while another entity is at a disadvantage. A blockchain is a distributed public ledger of transactions (such as financial transactions, data transactions, etc.) where transactions are recorded publicly and in chronological order and can be verified by stakeholders without central authority. The blockchain helps ensure that by applying cryptographic algorithms to a shared or distributed database, any user can read and add to the database, and no single user can control what is written to the distributed database. Any blockchain user can view all transactions regarding the distributed database. Blockchain technology provides, for example, direct sales to reduce intermediate steps in communication between data producers and data consumers. That is, instead of engaging an intermediary to facilitate transactions, two entities (such as a data consumer and a data provider) can connect and participate directly in the transaction. Since other entities can see the transaction, the blockchain acts as a distributed consensus engine for entities to verify the existence of the transaction and / or otherwise consent.

[0028] Figure 1 shows an exemplary blockchain 100 that includes a plurality of records or blocks 110, 120, 130. Each record 110, 120, 130 includes a hash value 112, 122, 132 (e.g., the hash value of the previous block in the chain 100 or other address), a timestamp 114, 124, 134 of the record 110, 120, 130, and an address of the root 116, 126, 136 of the blockchain 100. Further, each record 110, 120, 130 includes transactions 118-119, 128-129, 138-139 associated with the respective record 110, 120, 130. Thus, the blockchain 100 is a chain of cryptographically secure immutable blocks, timestamped, of consensus-confirmed data. The chain or ledger 100 exists, for example, as a series of synchronized copies with multiple users at multiple locations.

[0029] II. Exemplary nuclear medicine product management systems and related methods Some examples utilize blockchains and / or other distributed ledgers to help manage commodities that are prone to alteration in nuclear medicine images, namely, radioactive isotopes also referred to as radiotracers or radiopharmaceuticals. Since radioactive isotopes often decay rapidly over time, by tracking the shelf life of an item via a blockchain, suppliers and one or more potential buyers / users can evaluate the viability and shelf life of the substance until it becomes unusable for its intended purpose (e.g., for PET or SPECT imaging).

[0030] In some instances, the radioactive unit is linked to a digital unit that is managed by blockchain technology. The radioactivity can be represented as a cryptocurrency that is prone to deterioration, where the unit has to be spent within a finite duration of existence. The visibility of the units of this deteriorating currency circulating via the blockchain enables real-time trading and efficient use of the currency. Producers of radioactivity (e.g., a PET center synthesizing tracers, a generator manufacturer, etc.) issue new "currency" and circulate the supply. Users such as hospitals, clinics, imaging centers, etc. are the buyers who analyze the chain of records of radioactive pharmaceutical use and remaining shelf life for products and add to the chain. The product half-life, availability, as well as the time, date, and location of use can be tracked and managed via a blockchain (e.g., blockchain 100) to help ensure, for example, maximum use of available substances, quality control of products, and improved management of the nuclear imaging supply chain.

[0031] In some instances, a radiopharmaceutical generator supply chain (e.g., GE Drytec™, etc.) can be managed via blockchain 100 to provide sufficient traceability of each generator in the organization, the activity contained therein, and the location of the generators, products, and activities. In addition to the benefits of a highly traceable system, the distributed ledger provides additional transparency to end users. Further, the distributed ledger of blockchain 100 enables users to transact activities with each other. For example, if a hospital does not use its generator sufficiently during a given week, the hospital can transact the use of the generator to another nearby hospital that has more nuclear medicine tests scheduled during the same week and desires additional generator activity but cannot obtain an additional generator from the manufacturer (e.g., General Electric, etc.). This transaction between two end users, stored on blockchain 100, is also visible to the manufacturer, which can facilitate the collection and recycling of the generator regardless of whether the generator has changed location since being shipped to a particular customer. Thus, the manufacturer can know that the generator has been transferred from hospital A to hospital B and can, for example, request and / or expect the return of the generator from hospital B. Thus, blockchain 100 combines tracking and tracing capabilities with additional capabilities for exchanging activities among users. Blockchain 100 can also facilitate the billing of users according to the activity actually used, rather than changing the price per generator, which would disadvantage user A, who only partially uses a given activity.

[0032] In another example, PET tracer manufacturing can be managed via blockchain 100. The distributed ledger can make visible, for example, the tracer location (such as the location where a batch of GE's Vizamyl™ tracer is produced), how many activities a batch of tracers has, how the tracer batch can be administered to several dosages, and how these dosages are used. Leveraging the blockchain can facilitate improved use of tracer products among end-users by shipping surplus dosages from a batch at a PET center to other nearby locations where there is demand. For example, the blockchain can track shipments from a manufacturer to a first PET center, which then sells the remainder of the tracer shipment to a second PET center. An imaging facility that needs additional dosages of a particular PET tracer can obtain timely information about PET tracer production, for example, by accessing blockchain 100. The PET production facility can be positioned, for example, to measure demand via blockchain 100.

[0033] In some instances, a distributed ledger or blockchain can be constructed and / or extended by a generator or synthesizer that produces radiopharmaceutical substances. For example, GE's FASTlab™ platform can include a connection of a processor and a network for processing radioactivity measurements when a batch of a radioactive tracer substance (e.g., a PET tracer, etc.) is discharged. When a batch of a substance is generated and discharged by a synthesizer, a record or block representing a unit or usable amount of the substance is created in the chain. The record can include a measure of the amount of the substance and a timestamp for the creation of the substance. The timestamp enables tracking or monitoring of its shelf life as the substance begins to decay. By tracking the amount, time, and composition of the substance, the decay of the amount of the substance and the remaining shelf life can be determined and dynamically updated as time passes. The local system can generate records that are shared with a remote system (e.g., a cloud-based server, a central server, a customer system, etc.) for propagating the ledger and new records, for example. Thus, a customer system can view the records, purchase the substance, track the records and the passage of time, and provide new records when the substance is used (e.g., use a portion of the substance and sell the sustainable remainder to a secondary customer, etc.).

[0034] Figure 2 shows an exemplary apparatus or system 200 that includes a generator 210 for producing radiopharmaceutical substances and a dispensing monitoring processor 220 for generating records regarding the production of radiopharmaceutical substances and tracking their use and expiration. The dispensing monitoring processor 220 is connected to a controller 212 in the generator 210 to receive an indication of the amount of radioactive isotope substance synthesized in a cassette or other reactor 214 of the generator 210. The dispensing monitoring processor 220 generates records (such as type, amount, start timestamp, location, etc.) in a distributed ledger (such as a blockchain, hash graph, directed acyclic graph, etc.) corresponding to the produced substance. The dispensing monitoring processor 220 may relay the distributed ledger records and / or updates to the ledger to a remote server 230 (such as a cloud-based server operated by a provider of the generator 210, a third-party service provider, a clearinghouse or broker for the substance, and / or other remote servers). The remote server 230 can cooperate with the dispensing monitoring processor 220 to verify the distributed ledger, facilitate message exchange, associate potential users / buyers with the substance at its current location, etc.

[0035] The substance and / or information regarding the substance may be provided to a customer subsystem 240 that uses the substance, updates the relevant records, and / or adds new records indicating the use of a portion of the substance to the distributed ledger. The records in the distributed ledger can be used to monitor the shelf life of the substance and facilitate contracts and / or other agreements for the sale of all or part of the substance.

[0036] FIG. 3 shows an exemplary distributed ledger 300 similar to the exemplary blockchain 100, including records 310, 320, 330 corresponding to batches of radiopaque contrast agents produced by generator 210. For example, ledger 300 may be an implementation of blockchain 100 customized for records 310-330 of radiopharmaceutical substances, or ledger 300 may be an alternative distributed ledger for tracking the quantity, location, decay, etc. of radiopharmaceutical substances.

[0037] As shown in the exemplary ledger 300 of FIG. 3, when a batch of radiopharmaceutical substance is synthesized by generator 210, record 310 is created by processor 220. Exemplary record 310 includes an identifier 311 associated with record 310, a timestamp 312 corresponding to the synthesis of the substance by generator 210, the location 313 of generator 210, the type 314 of radiopharmaceutical substance, and the quantity 315 of the substance. Using type 314, quantity 315, and timestamp 312, when a half-life associated with type 314 starting with quantity 315 at the time of timestamp 312 is given, the remaining shelf life of the substance can be determined. Distribution monitoring processor 220 can track the degradation of the substance associated with record 310 over time and provide this information to, for example, remote server 230 and / or customer system 240. Additional records 320, 330 in distributed ledger 300 may be for the same and / or different batches of the substance. Thus, additional substances produced by the same or different generators 210 are associated with subsequent records 320, 330 and may have associated identifiers 321, 331, timestamps 322, 332, locations 323, 333, types 324, 334, quantities 325, 335, etc.

[0038] In some examples, the subsequent record 320 may be for a batch of the substance that is the same as the first record 310 after a certain amount of the substance has been used. The record 320 can indicate a remaining amount 325 that is different from the initial amount 315, and the useful life of the remaining amount 325 can be tracked using a timestamp 322, a type 334, etc. Activities such as the transportation time of the substance, sharing / usage, etc. are updated in the ledger 300 by the processor 220 and / or the remote server 230, and are, for example, put into elements of the decay calculation to determine the remaining useful life for the remaining amount 325 of the substance.

[0039] In some examples, when all of the substance has been used and / or the useful life of the substance has been exhausted, the associated records 310, 320, 330 can be deleted from the ledger 300. In other examples, the amounts 315 - 335 of the substance are reduced to zero, but the records 310 - 330 are maintained in the ledger 300 for purposes such as historical tracking and / or accounting audits. In some examples, the records 310 - 330 include additional fields indicating whether there is any usable / survivable substance remaining from the associated batch. Thus, records 310 - 330 that do not have fields indicating remaining usable / survivable substance may be ignored by the processor 220, the server 230, and / or the customer system 240, for example, when tracking an inventory of available substances, transacting / buying / selling, and / or otherwise managing them.

[0040] In some instances, each time a transaction occurs for selling or reselling all or a portion of a radiopharmaceutical substance, new records 310 - 330 are created in ledger 300 to track the substance. In other examples, such as shown in FIG. 3, transactions 316 - 337 occurring with respect to records 310 - 330 of the radiopharmaceutical substance are stored in or with respect to each block or record 310 - 330 in ledger 300. For example, the first transaction 316 may include selling the produced substance from the manufacturer's laboratory to the first hospital. The second transaction 317 may include reselling a portion of the substance from the first hospital to the second hospital. Similar transactions 326 - 327, 336 - 337 may be recorded for each record 310 - 330 in ledger 300.

[0041] Accordingly, in nuclear medicine, radioactive substances are used, and the substances are associated with known short decay times for radioactive isotopes. Further, some of the radioactive isotopes can be added to molecules that make the radioactive isotope a good contrast agent. However, these radioactive isotopes have a limited duration of existence and will be used before they decay. During the useful life of the radioactive isotope substance, its activity decreases (e.g., from 100 hours to 50 hours, 25 hours, etc.), and as a result, the intensity decreases. As the intensity decreases, the effectiveness of PET, SPECT, and / or other nuclear imaging decreases until the remaining substance is no longer sufficient to obtain a diagnostic quality image of the target. As a result, as the substance ages, the value of the radioactive isotope substance decreases. For example, an initial batch may be sufficient to dose multiple patients. However, soon, the substance will only be strong enough to dose one patient, and then the substance will decay to the point where it is not sufficient to dose anyone. Records 310-330 of the distributed ledger 300 allow the dispensing monitoring processor 220, the customer subsystem 240, and / or the remote server 230 to monitor the substance activity, including how much of the substance is produced, how much is administered, how much remains, where the substance is located, and how strong the substance remains. The information is shared and used for contracts / subcontracts for the calculation, estimation, and sale of the substance.

[0042] In some examples, remote server 230 and / or customer subsystem 240 provide an interface with dispensing monitoring processor 220, such that users / customers of radiopharmaceutical substances (e.g., hospitals, radiopharmacies, clinics, imaging centers, etc.) can view available substances within a transport / delivery radius at their locations to have substances transported with remaining shelf life for one or more desired imaging tasks. In some examples, a user / customer can borrow generator 210 to locally produce a substance and then transfer generator 210 to another customer and / or share the generated substance with another customer site, etc. Through coordination between decentralized ledger 300 and monitoring processor 220 and customer 240 system (e.g., via remote server 230), pre-cultures and / or other radiopharmaceutical substances are synthesized, dispensed, and redistributed in a decentralized manner, but information regarding substances and related transactions is maintained for all stakeholders to view and supplement through records 310-330 of decentralized ledger 300. When a batch of a substance is depleted, its records 310-330 can be deleted from ledger 300 and / or marked as depleted, used, inactive, etc.

[0043] In some examples, a user may submit a request for a certain amount of radioactivity and consent to generator 210 and / or a substance through a contract facilitated and represented by decentralized ledger 300 (e.g., via remote server 230 and / or dispensing monitoring processor 220). In some examples, the request remains in ledger 300 and / or on the interface until the request is fulfilled. In some examples, supplier A may have a desired amount at a first location at a first price, and supplier B may have a desired amount at a second location at a second price, which is at a second distance further from the user who received the request than the first distance. Thus, when the substance reaches the user who received the request, since supplier B is located remotely, the amount of available substance from supplier B is less than the desired amount. Distance, half-life, amount, and cost may be factors in determining the best supplier for the requesting user.

[0044] In some examples, the smart contract facilitated by the distributed ledger 300 of the dispensing monitoring processor 220 may lower the price as the attenuation of the substance progresses. That is, the smart contract provides a price that attenuates for the decaying product.

[0045] In some examples, cassettes and / or kits are provided to make Agent A or Agent B based on the same radioisotope but different organic molecules. For example, the cassette is barcoded to tell a particular agent which agent to make to a generator 210 such as a GE FASTlab™. The generator 210 goes through a programmed sequence to make the agent in the reactor 214. The controller 212 may calibrate the sensor to measure, for example, the radioactivity passing through the generator 210. Demand may be communicated from an end user such as one or more hospitals and / or other healthcare facilities associated with a PET center having the generator 210, correlated with and / or based on the patient schedule and the dosages required for imaging those patients. The dispensing monitoring processor 220 can work with the generator 210 and the customer subsystem 240 to form a work list for the radiopharmacy to produce, for example, one batch of Agent A on Monday, two batches of Agent B on Tuesday, and so on. The scheduling of radioisotope production and dispensing can be automated, including, for example, the demand and associated requirements for configuring and driving the generator 210 and the delivery and tracking to the customer. For example, timely communication, improved tracking, additional capabilities for management and dispensing, and improved utilization can be accomplished.

[0046] Rather than manually inferring or estimating with respect to time, progression, and decay, the monitoring processor 220 is connected to and / or otherwise communicates with the generator 210 to identify batches of substances, create records about the substances, and track the substances throughout their useful lives. In some examples, when a substance is depleted and / or otherwise becomes unusable, the record may be erased or deactivated, thereby reducing the expansion of the distributed ledger 300 beyond a size that can be easily shared between the dispensing monitoring processor 220, the remote server 230, other customer systems 240, etc.

[0047] FIG. 4 shows an exemplary implementation of system 200 that includes a dispensing monitoring processor 220, a remote server 230, and multiple customer subsystems 240, 245 that communicate with the generator 210. As shown in the example of FIG. 4, the first customer subsystem 240 may be associated with a first customer that purchases a substance from the generator 210. The synthesis, purchase, and / or shipment of a batch of the substance from the generator 210 to the customer may trigger the dispensing monitoring processor 220 to create records 310 - 330 about the batch of the substance and begin tracking its decay. The processor 220 may provide a copy of the ledger 300 that includes the updated records 310 - 330 to the remote / central server 230 and the customer subsystem 240.

[0048] After using a portion of the substance, the first customer may advertise the remaining substance for (re) sale (e.g., from customer subsystem 240, via processor 220 and / or remote server 230, etc.). The second customer may view ledger 300 and decide to purchase some or all of the remaining substance from the batch purchased by the first customer. The second customer subsystem 245 may participate in a transaction with the first customer subsystem 240 to purchase the substance, and new records 310 - 330 may be generated and / or existing records 310 - 330 may be updated in the ledger to reflect the transaction / transfer. The customer subsystems 240, 245 indicate the transaction records 310 - 330 in ledger 300, and the processor 220 and remote server 230 also receive the updated ledger 300 indicating the transaction. Monitoring of the expiration period of any remaining substance may continue until all usable substance is consumed and / or otherwise made unusable (e.g., by decay, too little amount, etc.).

[0049] In some examples, using ledger 300, when the amount is below the usable threshold but there is still an expiration period remaining for the substance, multiple smaller amounts of the substance may be combined by the customer into a larger usable amount of the substance. For example, the remaining substance may still be viable, but now it is too little in amount to satisfy the customer's PET, SPECT, and / or other nuclear imaging requirements. The processor 220 and / or remote server 230 may communicate with the customer subsystems 240, 245 to identify multiple smaller remaining batches of the substance and combine the substance into a single usable batch, e.g., for (re) sale.

[0050] FIG. 5 shows an exemplary smart contract 500 for the purchase of a radiopaque contrast agent synthesized by a generator 210 and tracked by a distributed ledger 300. The exemplary smart contract 500 can be stored as records 310-330 in the ledger by, for example, a dispensing monitoring processor 220, a remote server 230, customer subsystems 240, 245, etc. As shown in the example of FIG. 5, the contract 500 includes a value 510 (e.g., amount of substance, cost, etc.) and a status 520 (e.g., available, completed, executed, in progress, shipped, substance remaining, etc.). The contract 500 can also include one or more functions 530 executable with respect to the contract 500. Thus, the contract 500 can specify, for example, the status 520 of its terms 510 and the execution of those terms using one or more of the functions 530. For example, the functions 530 can include request, product, purchase, shipped, received, resell, return generator, kill, etc. The contract record 500 can receive transaction information 540 and event information 550 and provide transaction information 560 and event information 570 to other records 310-330 in the ledger 300 and / or systems such as the dispensing monitoring processor 220, the remote server 230, customer subsystems 240, 245, etc.

[0051] For example, transaction 540 may provide value 510 to contract 500, e.g., through the quantity of the substance to be purchased and / or other terms / conditions, to contract 500. Event 550 may affect the state 520 of contract 500, such as the timestamp of the creation of the substance, the time of delivery of the substance, the identification of the type of substance, etc., half-life. When the substance purchased under contract 500 is used and / or decays, transaction information 560 and event information 570 may be propagated to other records 310 - 330 and / or other systems 220 - 240. For example, the use of the substance and / or the passage of time, etc., may be event 570 that affects this and / or another contract 500 or records 310 - 330, etc. The consent to sell the remaining portion of the unused but available substance may be transaction 560 that affects this contract 500 and generates another contract 500 and / or related records 310 - 330, etc. Thus, smart contract 500 can be used to track sales, rentals, and / or other transactions involving generator 210, radioactive isotope substances, related services, etc., and smart contract 500 may automatically change when the substance (and / or generator 210) is used, decays, resold, etc.

[0052] The smart contract 500 can be implemented as computer program code that enables / facilitates the enforcement of a contract / agreement among the parties using the ledger 300 (e.g., between the generator 210 and the customer, etc.). Conditions and / or updates to the contract can be implemented as processor-executable instructions executed by the processor 220 and / or another processor to implement and / or track the execution of the contract 500. For example, monitoring the remaining shelf life in a batch of a substance being sold (e.g., based on the half-life associated with the type of the substance and the start / generation time of that substance, etc.) can be calculated by the smart contract 500, and the smart contract 500 then updates and / or creates new records 310 - 330 associated with the batch of the substance in the ledger 300 to reflect the updated information regarding the remaining substance and its shelf life. The terms of the contract 500 may be coded as logical statements that govern the conditions and results of the contract 500 and the related substances. The contract 500 may be sufficiently automated to execute on its own with respect to the distributed ledger 300, and / or may be executable by the processor 220, the remote server 230, the customer subsystems 240 - 245, etc. to satisfy the contract 500. Thus, the contract 500 may, for example, be formulated entirely in executable code and / or may include additional elements to be interpreted by a processor. The contract 500 is executed within the ledger 300 (e.g., the code forming the contract 500 is coded into the blocks of a blockchain and / or other distributed ledger 300, etc.), and / or may be executed outside of the ledger 300, and returns information (e.g., new and / or updated records 310 - 330, etc.) to the ledger 300, for example. In some examples, anyone can add the contract 500 and / or make changes to the records 310 - 330 in the ledger 300.In other examples, access to ledger 300 and related records 310 - 330, contract 500, etc. is restricted based on, for example, processor authorization (e.g., an authorized node), user authorization, etc.

[0053] FIG. 6 shows an exemplary peer update system 600 in which generator 210 provides substances purchased and used by customers, and transactions 602, 604 with customer subsystems 240, 245 are carried out for selling substances to respective customers. Such transactions are recorded as records 310 - 330 in distributed ledger 300 by distribution monitoring processor 220, and copies of transactions 602, 604 and / or records 310 - 330 are reflected in remote server 230, and customer subsystems 240, 245, and ledger 300 maintained by processor 220. Thus, additional, subtraction, exchange, resale, and / or other transactions involving substances from generator 210 (and / or use of generator 210 itself, etc.) are reflected in records 310 - 330 of ledger 300 and can be verified by peer systems 220 - 245 to confirm transaction accuracy and validity, remaining substance shelf life and quantity, related timing, etc. Thus, for transactions 602, 604 of each smart contract 500, a peer system having a copy of ledger 300 can verify the contract 500 (e.g., can verify substance type, half-life, and remaining shelf life), can track the protection chain of the substance and / or its generator 210, can dynamically determine allocation, and can verify the allocation of the substance and / or generator 210, etc. Thus, the peer system can provide feedback regarding record content, record updates, and transactions involving records, etc.

[0054] Therefore, the supplier and the user know how much material is being generated and how the material (and the generator) is being used. In some examples, the generator 210 is a device that is lent to a customer and then returned to the supplier to produce further products, which is difficult to deteriorate and not for sale. When customer A sells to customer B, for example, the supplier is unaware and cannot be tracked without the distributed ledger 300. Through the distributed ledger 300, smart contracts may be created and / or updated, locations may be monitored, pickups may be scheduled, usage may be tracked, etc. The smart contract 500 can calculate delays, estimate shipping / delivery times, schedule pickups, and determine and calculate the best supplier to provide the required items to the purchaser at the right time, as encoded in the smart contract 500. In some examples, Internet of Things (IoT) devices can automatically measure materials during production and retrieval for providing to the ledger 300 in real time (and / or with a given transmission and data processing latency that is near real time).

[0055] In some examples, prices can be monitored, recorded, and controlled via the distributed ledger 300. For example, price boundaries and / or other constraints can be imposed via the ledger 300 on transactions for materials and / or resources of the generator 210. In some examples, auctions and / or reverse auctions can be facilitated for the sale of materials, for the generator 210, etc., by the records 310 - 330 of the distributed ledger 300. Such transactions can occur quickly via the blockchain 300 while the material is still viable, and systematic reselling can be facilitated, for example, at prices determined by market principles.

[0056] In some examples, the smart contract 500 facilitates the radioactive pharmaceutical production and exchange process flow. For example, a user invokes a radioactive pharmaceutical purchase smart contract, such as a full-millimole (18F) tracer quantity request, and provides parameters 510 for starting the contract 500. Such parameters may include an initiator public key for identifying the initiator of the contract 500 as well as other parameter information 510 such as tracer type, quantity, requester address, delivery method, etc. The smart contract 500 includes function calls 530 for each step or action in the process.

[0057] For example, after starting a request for the smart contract 500 using the initiator's public key, the user then uses the parameters to call the request function 530 of the smart contract 500. The request function 530 places a request transaction on the blockchain or other distributed ledger 300. This transaction includes information for a laboratory to evaluate the request. A laboratory desiring to fulfill this request will call the produce function 530 of the smart contract 500. The address of the smart contract 500 is, for example, in the request transaction.

[0058] In some examples, the same instance of the smart contract 500 is used for all transactions. Multiple laboratories may respond to a request transaction by calling the produce function 530 of the smart contract 500. For each laboratory that calls the produce function 530, transactions 316 - 337 are added to blocks 310 - 330 in the blockchain 300. The initiator of the contract 500 can evaluate all the produce transactions 316 - 337 and select a manufacturer for the required tracer from any of the produce transactions 316 - 337.

[0059] The initiator of the contract 500 can then call the purchase function 530 of the smart contract 500, which places the purchase transactions 316 - 337 into the blocks 310 - 330 on the blockchain 300 and also sends the purchase information to the selected laboratory. This call also disables the produce function 530 of the smart contract 500, signaling that the laboratory has responded to the request by this contract 500. If multiple produce transactions 316 - 337 are received, the smart contract 500 notifies other laboratories that their produce transactions were not selected.

[0060] The laboratory acknowledges the contract and then produces the tracer and delivers the tracer to the laboratory under the terms of the smart contract 500. When produced, the laboratory calls the deliver function 530 of the smart contract 500, which also places the deliver transactions 316 - 337 into the blocks 310 - 330 on the blockchain 300 and sends the information directly to the laboratory.

[0061] When the initiator receives the tracer, the received function 530 of the smart contract 500 is called, and transactions 316 - 337 are added to blocks 310 - 330 of the blockchain 300 and are also sent directly to the laboratory. When all the terms of the smart contract 500 are satisfied by both sides, the smart contract 500 is concluded and added to the blockchain 300 as transactions 316 - 337. If any condition is not satisfied, the smart contract 500 calls the penalties and / or other branches specified in the smart contract 500. If the payment and / or other terms of the smart contract 500 are not satisfied by the initiator, a penalty may be imposed on the initiator. When all the terms of the contract 500 are satisfied, the smart contract 500 is concluded, added to blocks 310 - 330 on the blockchain 300, and the instance of the smart contract 500 is deleted from the system (for example, the called instance of the smart contract 500 is erased, not the entire blockchain 300).

[0062] At any given time, there may be multiple instances of the called smart contract 500 in the system that places transactions 316 - 337 into blocks 310 - 330 of the blockchain 300. In some examples, each instance is a requirement regarding the tracer and follows the flow specified above.

[0063] The above workflow is an example for a PET tracer with a short half - life such as 110 minutes, and these are very time - constrained workflows. For other tracers such as the "99mTc generator" shipped in a generator with a parent half - life of 66 hours, the workflow is not as time - constrained. Therefore, different smart contracts 500 can be used.

[0064] For example, a user calls a radioactive pharmaceutical sales smart contract 500 with parameters 510 for starting contract 500. Exemplary parameters 510 include the public key of the seller that identifies the initiator and other information such as tracer type, quantity, address, delivery method, etc. This smart contract 500 also includes function calls 530 for each step or action in the process. For example, after starting the radioactive pharmaceutical sales smart contract 500 with the public key of the initiator, the initiator then calls the sell function 530 of the smart contract 500 with relevant parameters 510. The sell function 530 can add details of tracer sales transactions 316 - 337 into the blockchain 300. These transactions 316 - 337 contain information for a prospective buyer to evaluate the offer. The address of the smart contract 500 is in the sales transactions 316 - 337, and for example, the same instance of the smart contract 500 is used for all transactions.

[0065] When a laboratory or a buyer wants to buy a tracer, they call the purchase function 530 within the smart contract 500. Those transactions 316 - 337 are added to blocks 310 - 330 in the blockchain 300. The initiator (manufacturer) of the contract 300 then either calls the produce function 530 of the smart contract 500 to produce the tracer or may proceed directly to the shipped function if the tracer is already in stock. When the tracer is shipped, the appropriate (produce or shipped) transactions 316 - 337 are placed in blocks 310 - 330 on the blockchain 300, and the shipping information is sent to the laboratory.

[0066] When the buyer receives the tracer, the received function 530 of the smart contract 500 is called, and transactions 316 - 337 are added to blocks 310 - 330 and further sent directly to the laboratory. In this use case example, the tracer is shipped in the generator containing the base material. The buyer generates the actual dosage from the base material in the generator. By doing so, multiple dosages are made possible, and thanks to the longer half-life of the parent, it also contributes to resale.

[0067] The original (or subsequent buyer) may resell or retain the generator. When the base material can no longer survive (or at any time), the current purchaser of the tracer may call the return generator function 530 of the smart contract 500.

[0068] When the manufacturer receives the returned generator, the contract 500 is completed. If all terms of the smart contract 500 are satisfied by all parties, the smart contract itself 500 should be concluded and added to the blockchain 300 as transactions 316 - 337. If any condition is not met, the smart contract 500 calls the penalties and / or other branches specified in the smart contract 500. If payment or other terms of the smart contract 500 are not satisfied, a penalty may be imposed on either party.

[0069] When all the terms of the contract 500 are satisfied, the smart contract 500 is concluded and added as transactions 316 - 337 to blocks or records 310 - 330 on the blockchain or other distributed ledger 300, and the instance of the smart contract 500 is deleted from the system (only the called instance of the smart contract 500, not the blockchain 300, is erased). In some examples, all of the resell, purchased, shipped, and received functions of the smart contract 500 may be called multiple times during the life of the contract 500 if a resale occurs.

[0070] Figure 7 shows an exemplary set 700 of smart contracts 710 - 730. Each contract 710 - 730 in the list 700 includes a model of information such as an owner 712 - 732, a manufacturer 714 - 734, and one or more functions 716 - 736 executable with respect to the smart contracts 710 - 730. Thus, the model / data structure for each smart contract 710 - 730 defines, for example, its owner 712 - 732, its associated manufacturer 714 - 734, and one or more functions 716 - 736 executable by an entity with respect to the contracts 710 - 730. For example, Figure 7 shows a tracer quantity requirement contract 710, which defines a contract owner 712, a tracer quantity manufacturer 714, and provides a plurality of functions 716 executable with respect to the smart contract 710, including request (e.g., tracer quantity request), produce (e.g., tracer quantity production), purchase (e.g., tracer quantity purchase), shipped (e.g., tracer quantity shipped), received (e.g., tracer quantity received), resell (e.g., tracer quantity resellable), kill (e.g., end of order / use, deletion of contract instance), etc.

[0071] The example of FIG. 7 also shows a tracer dosage sales contract 730, which defines a contract owner 732, a tracer dosage manufacturer 734, and provides a plurality of functions 736 executable with respect to the smart contract 730, including request (e.g., tracer dosage request), produce (e.g., tracer dosage production), purchase (e.g., tracer dosage purchase), shipped (e.g., tracer dosage shipped), received (e.g., tracer dosage received), resell (e.g., tracer dosage resellable), kill (e.g., end of order / use, deletion of contract instance), etc.

[0072] FIG. 8 shows an exemplary transaction flow 800 for an exemplary radiopharmaceutical blockchain 802 (e.g., implementing the exemplary distributed ledger 300 of FIG. 3). As shown in the example of FIG. 8, at 1, a first laboratory 801 polls the blockchain 802 to find an open request contract for Tracer B that meets the criteria that the laboratory 801 can produce according to the terms of the smart contract 803. At 2, a hospital 804 calls the request smart contract 803. The call of the smart contract 803 is stored as a transaction in block 1 of the blockchain 802.

[0073] At 3, the request contract 803 in block 1 is determined to meet the requirements of the polling function, and the laboratory 801 calls the produce function of the smart contract 803. The call of the produce function is added as a transaction to the blockchain 802 in block 3. Information about the transaction may be sent directly to the system at the hospital 804.

[0074] In 4, hospital 804 receives produce contract 803 and selects one or more tracer B order quantities. The purchase method of contract 803 is called for each desired contract 803, the details of contract 803 are added to block 4 of blockchain 802, and this also notifies the laboratory 801 of the purchase.

[0075] In 5, laboratory 801 is sent the details of the purchase method of contract 803 and responds to the order for the amount of tracer B. Laboratory 801 calls the shipped method of smart contract 803, and the transaction is added to block 5 of blockchain 802. The system of hospital 804 is also notified of the transaction. In 6, hospital 804 receives the shipped contract and calls the received method of contract 803. Smart contract 803 can be satisfied, for example, based on the receipt of the substance at hospital 804.

[0076] In 7, hospital 804 has excess substances that are not needed. The hospital system 804 can, for example, poll for requests and / or call the resell method of smart contract 803 to find potential buyers for the excess substances.

[0077] Exemplary implementations are shown along with FIGS. 1-8, but the elements, processes, and / or devices shown along with FIGS. 1-8 may be combined, divided, rearranged, omitted, removed, and / or implemented in any other way. Further, the components disclosed and described herein may be implemented by hardware, machine-readable instructions, software, firmware, and / or any combination of hardware, machine-readable instructions, software, and / or firmware. Thus, for example, the components disclosed and described herein may be implemented by analog and / or digital circuitry, logic circuitry, programmable processors, application specific integrated circuits (ASICs), programmable logic devices (PLDs), and / or field programmable logic devices (FPLDs). When reading any of the apparatus or system claims of this patent to cover purely software and / or firmware implementations, at least one of the components is clearly defined herein to include a tangible computer-readable storage device or memory storing software and / or firmware, a storage disk such as a digital versatile disk (DVD), a compact disk (CD), a Blu-ray disk, etc.

[0078] A flowchart representing exemplary machine-readable instructions for implementing the components disclosed and described herein, at least in conjunction with FIGS. 1-8, is shown in the example of FIG. 9. In these examples, the machine-readable instructions include a program for execution by a processor, such as processor 1012 shown in exemplary processor platform 1000, discussed below in connection with FIG. 10. The program may be embodied in machine-readable instructions stored on a tangible computer-readable storage medium such as a CD-ROM, floppy disk, hard drive, digital versatile disk (DVD), Blu-ray disk, or memory associated with processor 1012, but the entire program and / or some of its parts may alternatively be executed by a device other than processor 1012 and / or embodied in firmware or dedicated hardware. Further, the exemplary program is described with reference to the flowcharts shown at least in conjunction with FIGS. 1-8, but many other ways of implementing the components disclosed and described herein may alternatively be used. For example, the order of execution of the blocks may be changed and / or some of the blocks described may be changed, removed, or combined. The flowcharts of at least FIGS. 1-8 show the exemplary operations in the order illustrated, but these operations are not exhaustive and are not limited to the order illustrated. Further, various changes and modifications may be made by those skilled in the art within the spirit and scope of the present disclosure. For example, the blocks shown in the flowchart may be implemented in alternative orders and / or in parallel.

[0079] As described above, at least the exemplary process of FIG. 9 can be implemented using encoded instructions (e.g., computer and / or machine-readable instructions) stored on a tangible computer-readable storage medium such as a hard disk drive, flash memory, read-only memory (ROM), compact disk (CD), digital versatile disk (DVD), cache, random access memory (RAM), and / or any other storage device or storage disk where information is stored for any duration (e.g., for an extended time period, permanently, for a short instant, for temporarily buffering, and / or for caching information). The term tangible computer-readable storage medium as used herein is clearly defined to include any type of computer-readable storage device and / or storage disk and to exclude propagated signals and to exclude transmission media. As used herein, the terms “tangible computer-readable storage medium” and “tangible machine-readable storage medium” are used interchangeably. Additionally or alternatively, at least the exemplary process of FIG. 9 can be implemented using encoded instructions (e.g., computer and / or machine-readable instructions) stored on a non-transitory computer and / or machine-readable medium such as a hard disk drive, flash memory, read-only memory, compact disk, digital versatile disk, cache, random access memory, and / or any other storage device or storage disk where information is stored for any duration (e.g., for an extended time period, permanently, for a short instant, for temporarily buffering, and / or for caching information). The term non-transitory computer-readable medium as used herein is clearly defined to include any type of computer-readable storage device and / or storage disk and to exclude propagated signals and to exclude transmission media. As used herein, the phrase “at least” is as open-ended as the term “comprising” when used as a transitional term in the preamble of a claim. Further, the term “including” is as open-ended as the term “comprising”.

[0080] FIG. 9 shows a flowchart of an exemplary method 900 for managing a radiopharmaceutical generator and monitoring radiopharmaceutical substances synthesized by the generator. At block 902, a radiopharmaceutical substance is synthesized. For example, a generator 210, such as a FASTlab (trademark) or Drytec (trademark) generator device, synthesizes a batch of radioisotopes for use in PET imaging in a hospital. At block 904, the substance is recorded in a distributed ledger 300. For example, records 310 - 330, including the type of substance, the amount of the substance, the time of substance creation and / or discharge, the intended recipient / purchaser / customer of the substance, etc., may be created in the ledger 300. At block 906, the distribution of the substance to the intended recipient is tracked via the ledger 300 (e.g., by updating and / or creating new records 310 - 330 with information such as the location, amount, shelf life of the substance, etc., by adding transactions 316 - 337 to records 310 - 330, etc.). For example, an imaging center receives a radiopaque substance for nuclear imaging at the center.

[0081] At block 908, the ledger 300 is updated based on the distributed substance. For example, records 310 - 330 associated with a batch of the substance can be adjusted as the substance ages and its usefulness decreases with each half-life. Records 310 - 330 are updated with transactions 316 - 337 and / or new records 310 - 330 can be created based on, for example, the remnants of the substance left after use by a customer. Records 310 - 330 can be updated based on, for example, the location of the substance. At block 910, the substance is monitored. Thus, a decrease in shelf life, a change in location, a change in amount, a change in status (e.g., in use, for sale, etc.) are monitored and noted (e.g., by a distribution monitoring processor 220, a remote server 230, customer subsystems 240 - 245, etc.).

[0082] In block 912, the monitored substance is evaluated to determine whether usable substance remains. If insufficient usable substance remains (e.g., insufficient usable substance for a nuclear imaging procedure, etc.), in block 914, the records 310 - 330 associated with the substance in the ledger 300 are updated (e.g., by adding transactions 316 - 337 to the records), and process 900 returns.

[0083] However, if usable substance remains, in block 916, the ledger 300 is updated such that the records 310 - 330 (e.g., existing records and / or new records) reflect the status of the substance (e.g., quantity, elapsed time, remaining time, location, next destination, etc.). In block 918, the substance and its associated records 310 - 330 are evaluated to determine whether the next destination is available for redistribution of the substance. For example, customer A may sell the remaining substance to customer B, the supplier to customer A may sell the remainder to customer B, customers A and B may jointly purchase the substance, or customer A may now be providing the remainder to B. If the substance is to be redistributed, in block 920, the distribution of the substance is tracked via the ledger 300 (e.g., by updating and / or creating new records 310 - 330 with the location, quantity, expiration period, etc. of the substance). In block 922, the ledger 300 is updated based on its use at the new location (e.g., by adding transactions 316 - 337 to the records 310 - 330).

[0084] FIG. 10 is a block diagram of an exemplary processor platform 1000 constructed to execute at least the instructions of FIG. 9 for implementing the exemplary components disclosed and described herein with respect to FIGS. 1 - 8. The processor platform 1000 can be, for example, a server, a personal computer, a mobile device (e.g., a tablet such as a cellular phone, smartphone, iPad™), a personal digital assistant (PDA), an Internet appliance, or any other type of computing device.

[0085] The illustrated example of the processor platform 1000 includes a processor 1012. The illustrated example of the processor 1012 is hardware. For example, the processor 1012 may be implemented by an integrated circuit, logic circuit, microprocessor, or controller from any desired family or manufacturer.

[0086] The illustrated example of the processor 1012 includes local memory 1013 (e.g., a cache). The exemplary processor 1012 of FIG. 10 executes at least the instructions of FIG. 9 and related methods for implementing the systems and infrastructure of FIGS. 1 - 8, such as the exemplary controller 212, exemplary distribution monitor processor 220, exemplary remote server 230, exemplary customer subsystems 240 - 245, exemplary distributed ledger 300, exemplary smart contract 500, or, more generally, the exemplary system 200. The illustrated example of the processor 1012 communicates via a bus 1018 with a main memory that includes volatile memory 1014 and non - volatile memory 1016. The volatile memory 1014 may be implemented by synchronous dynamic random access memory (SDRAM), dynamic random access memory (DRAM), RAMBUS dynamic random access memory (RDRAM), and / or any other type of random access memory device. The non - volatile memory 1016 may be implemented by flash memory and / or any other desired type of memory device. Access to the main memory 1014, 1016 is controlled by a clock controller.

[0087] The illustrated example of the processor platform 1000 also includes an interface circuit 1020. The interface circuit 1020 may be implemented according to any type of interface standard, such as an Ethernet interface, a Universal Serial Bus (USB), and / or a PCI Express interface.

[0088] In the illustrated example, one or more input devices 1022 are connected to the interface circuit 1020. The input devices 1022 permit a user to enter data and commands into the processor 1012. The input devices may be implemented, for example, by sensors, microphones, cameras (still or video), keyboards, buttons, mice, touchscreens, trackpads, trackballs, isopoints and / or voice recognition systems.

[0089] One or more output devices 1024 are also connected to the interface circuit 1020 of the illustrated example. The output devices 1024 may be implemented, for example, by display devices (such as light-emitting diodes (LEDs), organic light-emitting diodes (OLEDs), liquid crystal displays, cathode ray tube displays (CRTs), touchscreens, haptic output devices, and / or speakers). The interface circuit 1020 of the illustrated example thus typically includes a graphics driver card, a graphics driver chip or a graphics driver processor.

[0090] The interface circuit 1020 of the illustrated example also includes communication devices, such as transmitters, receivers, transceivers, modems and / or network interface cards, to facilitate the exchange of data with external machines (such as any type of computing device) via a network 1026 (such as an Ethernet connection, a digital subscriber line (DSL), a telephone line, a coaxial cable, a cellular telephone system, etc.).

[0091] The illustrated example processor platform 1000 also includes one or more mass storage devices 1028 for storing software and / or data. Examples of such mass storage devices 1028 include floppy disk drives, hard drive disks, compact disk drives, Blu-ray disk drives, RAID systems, and digital versatile disk (DVD) drives.

[0092] The encoded instructions 1032 of FIG. 10 may be stored in the mass storage device 1028, in the volatile memory 1014, in the non-volatile memory 1016, and / or on a removable tangible computer-readable storage medium such as a CD or DVD.

[0093] As shown in the example of FIG. 11, the distribution monitoring processor 220 may be implemented using the ledger record processor 222, the contract generator 224, the substance status monitor 226, the data communication interface 228, and the data storage 229 for storing data, instructions, etc. including a copy of the ledger 300. In the example of FIG. 11, the ledger record processor 222 is for creating, modifying, and / or otherwise processing records 310-330 in the distributed ledger 300. Updates to the ledger 300 can be communicated to other devices 230, 240, 245 having a copy of the distributed ledger 300, for example, via the communication interface 228. The exemplary contract generator 224 can generate, modify, and / or otherwise process smart contracts 500 with generators 210, synthesized substances, etc. The exemplary substance status monitor 226 can communicate via the data communication interface 228 to collect information for tracking the status of radiopharmaceutical substances, such as location, quantity, elapsed time, etc., from generators 210, remote servers 230, customer subsystems 240, 245, etc. The substance status monitor 226 can provide updates to the ledger record processor 222, the contract generator 224, etc. The data communication interface 228 facilitates the exchange of information, instructions, verification, other feedback, etc. between generators 210, processors 220, remote servers 230, customer subsystems 240-245, etc. The data storage 229 stores a copy of the processor 220 of the distributed ledger 300 along with other data, operation instructions, configuration parameters, etc.

[0094] From the above, it will be appreciated that the disclosed methods, apparatus, and articles of manufacture are disclosed to implement a distributed ledger that tracks radiopharmaceutical substances, generators, and / or other equipment and enables distribution, usage, and / or rental agreements and ancillary / secondary agreements for the use of substances, generators, etc. The disclosed methods, apparatus, and articles of manufacture improve the operation of a radiopharmaceutical generator and / or other computing device by enabling it to cooperate with a remote server and / or customer subsystem via a processor to quantize, track, manipulate, and manage decaying radiopharmaceutical substances as it synthesizes them. The disclosed methods, apparatus, and articles of manufacture thus target one or more improvements in the functionality of a computer and / or computing device, including a radiopharmaceutical generator, monitoring processor, etc.

[0095] Although several exemplary methods, apparatus, and articles of manufacture have been described herein, the scope of this patent is not limited thereto. On the contrary, this patent covers all methods, apparatus, and articles of manufacture that properly fall within the scope of the claims of this patent.

Explanation of Reference Numerals

[0096] 200 Apparatus, System 210 Generator 212 Controller 214 Reactor 220 Distribution Monitoring Processor, Processor, Monitoring Processor 222 Ledger Record Processor 224 Contract Generator 226 Substance Status Monitor 228 Data Communication Interface, Communication Interface 229 Data Storage 230 Remote Server, Server, Central Server, Device 240 Customer Subsystem, Customer System, Device 245 Customer Subsystem, Device 600 Peer Update System 800 Transaction Flow 1000 Processor Platform 1012 Processor 1013 Local Memory 1014 Volatile Memory, Main Memory 1016 Non-Volatile Memory, Main Memory 1018 Bus 1020 Interface Circuit 1022 Input Device 1024 Output Device 1026 Network 1028 Mass Storage Device 1032 Encoded Instruction

Claims

Claim 1 A distribution monitoring processor device, a data storage for storing instructions for execution and a first copy of a distributed ledger, a data communication interface for receiving and transmitting data, a substance status monitor for tracking the status of a batch of radioactive pharmaceutical substances, the substance status monitor for receiving instructions of a type, quantity, and timestamp associated with the batch of radioactive pharmaceutical substances via the data communication interface, a ledger record processor for generating and updating records in the first copy of the distributed ledger using the type, quantity, and timestamp instructions associated with the batch of radioactive pharmaceutical substances from the substance status monitor, the ledger record processor for adding a transaction to the record to track how much of the batch of radioactive pharmaceutical substances is sold and resold, comprising, after a first use via a transaction added to the record, the substance status monitor is for tracking the first use of the batch of radioactive pharmaceutical substances and the remaining shelf life of the batch of radioactive pharmaceutical substances, and for updating the records in the first copy of the distributed ledger by the ledger record processor to reflect the remaining quantity and remaining shelf life of the batch of radioactive pharmaceutical substances. An apparatus for this purpose. Claim 2 A contract generator for generating a smart contract to accompany the batch of radioactive pharmaceutical substances and a customer subsystem associated with a first customer, the first customer receiving the batch of radioactive pharmaceutical substances, the smart contract facilitating the request, sale, and resale of the batch of radioactive pharmaceutical substances by the smart contract including a resale of a portion of the batch of radioactive pharmaceutical substances to a second customer. The apparatus according to claim 1, further comprising a contract generator. Claim 3 The apparatus according to claim 2, wherein the smart contract includes a function for triggering the generator to synthesize the batch of radioactive pharmaceutical substances. Claim 4 The ledger record processor is for communicating an update to at least one of a remote server or a customer subsystem via the data communication interface for a record of the first copy of the distributed ledger, the apparatus according to claim 1.

5. At least one of the remote server or the customer subsystem is for verifying the update to the record of the first copy of the distributed ledger, the apparatus according to claim 4.

6. The material situation monitor is to be connected to a generator, and when a batch of the radiopharmaceutical substance is synthesized by the generator, triggers the ledger record processor to generate the record, the apparatus according to claim 1.

7. The batch of the radiopharmaceutical substance includes a radiopharmaceutical substance for positron emission tomography, the apparatus according to claim 1.

8. A computer-readable storage medium which, when executed, causes at least one processor to at least track the situation of a batch of a radiopharmaceutical substance, the situation including a type, amount, and timestamp associated with the batch of the radiopharmaceutical substance, generate a record in a first copy of a distributed ledger using the type, amount, and timestamp associated with the batch of the radiopharmaceutical substance, update the record based on at least one of use of the batch of the radiopharmaceutical substance, resale of at least a portion of the batch of the radiopharmaceutical substance, and decay of the batch of the radiopharmaceutical substance, share the record having a second copy of the distributed ledger and includes instructions for causing. The instructions, when executed, cause the at least one processor to, at least after a first use via a transaction added to the record, update the record in the first copy of the distributed ledger to reflect the remaining amount and remaining shelf life of the batch of the radiopharmaceutical substance, and after the first use of the batch of the radiopharmaceutical substance, track the first use of the batch of the radiopharmaceutical substance and the remaining shelf life of the batch of the radiopharmaceutical substance, a computer-readable storage medium.

9. When executed, the command causes the at least one processor to generate a smart contract that involves at least a batch of the radiopharmaceutical substance and a customer subsystem associated with a first customer, wherein the first customer receives the batch of the radiopharmaceutical substance, and the smart contract further causes the batch of the radiopharmaceutical substance to be requested, sold, and resold according to the smart contract that includes reselling a portion of the batch of the radiopharmaceutical substance to a second customer. The computer-readable storage medium according to claim 8.

10. The computer-readable storage medium according to claim 9, wherein the smart contract is for including a function for triggering a generator to synthesize a batch of the radiopharmaceutical substance.

11. When executed, the command causes the at least one processor to communicate an update to at least one of a remote server or a customer subsystem with respect to the record of the first copy of the distributed ledger. The computer-readable storage medium according to claim 8.

12. When executed, the command causes the at least one processor to verify the update to the record based on feedback from at least one of the remote server or the customer subsystem. The computer-readable storage medium according to claim 11.

13. When executed, the command causes the at least one processor to generate the record when a batch of the radiopharmaceutical substance is synthesized by a generator that communicates with the at least one processor. The computer-readable storage medium according to claim 8.

14. A method implemented on a computer for managing a radiopharmaceutical substance, comprising: tracking, using at least one processor, the status of a batch of a radiopharmaceutical substance, the status including a type, an amount, and a timestamp associated with the batch of the radiopharmaceutical substance; and generating, using the at least one processor, a record in a first copy of a distributed ledger using the type, the amount, and the timestamp associated with the batch of the radiopharmaceutical substance. Using the at least one processor, updating the record based on at least one of use of a batch of the radiopharmaceutical substance, resale of at least a portion of the batch of the radiopharmaceutical substance, and decay of the batch of the radiopharmaceutical substance; Using the at least one processor, sharing the record having a second copy of the distributed ledger; comprising; Tracking the status of the batch of the radiopharmaceutical substance includes, after a first use via a transaction added to the record, tracking the first use of the batch of the radiopharmaceutical substance and the remaining shelf life of the batch of the radiopharmaceutical substance so as to reflect the remaining quantity and remaining shelf life of the batch of the radiopharmaceutical substance in the first copy of the distributed ledger, and updating the record in the first copy of the distributed ledger. A method.

15. Generating a smart contract to involve a batch of the radiopharmaceutical substance and a customer subsystem associated with a first customer, the first customer receiving the batch of the radiopharmaceutical substance, and the smart contract comprising: The method of claim 14, further comprising facilitating requesting, selling, and reselling a batch of the radiopharmaceutical substance by the smart contract, including reselling a portion of the batch of the radiopharmaceutical substance to a second customer.

16. The method of claim 15, further comprising triggering a generator to synthesize a batch of the radiopharmaceutical substance by a function of the smart contract.

17. The method of claim 14, further comprising communicating an update to the record in the first copy of the distributed ledger to at least one of a remote server or a customer subsystem.

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