Radioisotope delivery system with multiple detectors to detect gamma and beta emissions

Abstract

A nuclear medicine infusion system (10) may be used to generate and infuse radioactive liquid into a patient undergoing a diagnostic imaging procedure. In some examples the infusion system includes a frame (30) that carries a radioisotope generator (52) that generates radioactive eluate via elution. The frame may also carry a beta detector (58) and a gamma detector (60). The beta detector can be positioned to measure beta emissions emitted from the radioactive eluate supplied by the generator. The gamma detector can be positioned to measure gamma emissions emitted from a portion of the radioactive eluate to evaluate a safety of the radioactive eluate delivered by the infusion system.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No.62 / 397,022, U.S. Provisional Patent Application No. 62 / 397,025, and U.S. Provisional Patent Application No. 62 / 397,026, each of which was filed on September 20, 2016. The entire contents of these applications are incorporated herein by reference.TECHNICAL FIELD

[0002] This disclosure relates to radiopharmaceuticals used in nuclear medicine and, more particularly, to systems and techniques for generating and delivering radiopharmaceuticals.BACKGROUND

[0003] Nuclear medicine employs radioactive material for therapy and diagnostic imaging. Positron emission tomography (PET) is one type of diagnostic imaging, which utilizes doses of radiopharmaceutical. The doses of radiopharmaceutical may be injected or infused into a patient prior to or during a PET scan procedure. An infused dose of radiopharmaceutical can be absorbed by cells of a target organ of the patient and emit radiation. A PET scanner can detect the emitted radiation in order to generate an image of an organ. For example, to image body tissue such as the myocardium, a patient may be injected or infused with rubidium-82 (82Rb). Rubidium-82 may exhibit similar physiological uptake as potassium and, accordingly, may be taken into the myocardium following potassium pathways.

[0004] Rubidium-82 can be generated for nuclear medicine procedures using a strontium-rubidium generator (82Sr / 82Rb generator). Rubidium-82 is a radioactive decay product of strontium-82. Typically, strontium-rubidium generators contain strontium bound to a generator column through which an eluant is flushed during operation. As strontium-82 decays to rubidium-82, the rubidium-82 may release from the generator column and enter the eluant. The resulting stream, which is called an eluate, can be injected or infused into a patient.SUMMARY

[0005] In general, the disclosure is directed to devices, systems, components, and techniques for generating and / or delivering radioactive liquids. The radioactive liquid may be generatedland infused into a patient during a diagnostic imaging procedure, such as a positron emission tomography (PET) / computed tomography (CT) or a positron emission tomography(PET) / magnetic resonance imaging (MRI) procedure. Before, during, and / or after a specific diagnostic imaging procedure, the radiation level of radioactive liquid generated by an infusion system may be measured to determine the activity level (e.g., magnitude of radiation emissions) of one or more radioisotope in the radioactive liquid. The activity level of one or more radioisotopes may be measured to determine that a radioisotope targeted for infusion into a patient during an imaging procedure is at an appropriate level for the specific procedure being undertaken. Additionally or alternatively, the activity level of one or more radioisotopes may be measured to determine if a radioisotope having a longer half-life than the radioisotope targeted for infusion is present above a threshold concentration in the radioactive liquid. Such comparatively long-lasting radioisotopes may be contaminants that are desirably excluded from infusion into a patient.

[0006] For example, in the application of a strontium-rubidium radioisotope generator, a radioactive eluate containing the radioisotope rubidium-82 (also referred to as 82Rb and Rb-82) can be generated by passing an eluant across a substrate containing bound strontium-82 (also referred to as 82Sr and Sr-82). As Sr-82 decays into Rb-82, the Rb-82 may release from the substrate, causing the Rb-82 to release into the eluant and thereby generating a radioactive eluate via elution. As the radioisotope generator approaches the end of its service life, strontium may itself begin releasing into the eluate produced by the generator in addition to its decay product Rb-82. The activity level of strontium in the eluate may be monitored to help ensure that eluate containing too much strontium (or other contaminating radioisotope) is not injected into the patient. This is because Sr-82 has a much longer half-life (25.5 days) than the half-life of Rb-82 (76 seconds) and, if injected into the patient, will produce radioactive emissions inside of patient for a longer period of time than Rb-82.

[0007] In some examples according to the present disclosure, an infusion system is described that includes multiple detectors positioned to evaluate the safety of radioactive eluate generated by a radioisotope generator. The multiple detectors may each be used to determine the activity of the same or different radioisotopes in the radioactive eluate. Each detector can detect radioactive emissions emitted from the radioactive eluate, and the activity level, or concentration, of one or more radioisotopes that may be present in the radioactive eluate can be determined therefrom. In some configurations, the multiple detectors are implemented using a beta detector and a gamma detector.

[0008] A beta detector can measure beta emissions caused by radioactive beta decay. During beta decay, a beta particle that is either an electron or a positron is emitted from an atomic nucleus. The beta detector can detect beta particles emitted from the radioactive eluate, allowing the activity level of a radioisotope assumed to be associated with those beta particles to be determined. By contrast, the gamma detector can measure gamma emissions or photons caused by radioactive gamma decay. During gamma decay, a stream of high-energy photons may be emitted from an atomic nucleus, providing detectable gamma rays. The energy level of the gamma rays may vary depending on the specific radioisotope from which the rays are emitted. The gamma detector can detect the gamma emissions, for example by measuring a full or partial gamma spectrum, allowing the activity level of one or more radioisotopes to be determined. A gamma detector can discriminate photons with different energy levels, unlike a dose calibrator.

[0009] Activity measurements made by a beta detector and a gamma detector aredistinguishable from activity measurements made by a dose calibrator. A dose calibrator is an instrument used to assay the activity of a radioactive material prior to clinical use. The objective of the assay is to assure that the patient receives the prescribed dose for the diagnostic or therapeutic purpose. A dose calibrator includes an electrometer designed to measure a wide range of ionization current, spanning from femtoamperes (fA) for beta emitters up to tens of picoamperes (pA) for high-energy, high-yield photon emitters. Some high-activity assays can even involve microamperes (μΑ) currents. The accuracy of the electrometer depends upon the type and quality of the electrometer and the accuracy of the standard reference sources used to calibrate the electrometer. Dose calibrators have no intrinsic photon energy discrimination capability. A dose calibrator does not include a spectrometer and does not restrict the measurement to specific photon energies to the exclusion of others, which a gamma detector is capable of performing.

[0010] While the configuration of the radioisotope generator system can vary as described herein, in some examples, the system includes a beta detector positioned to measure the radioactivity of eluate flowing through tubing positioned adjacent the beta detector. The gamma detector may also be positioned to measure the radioactivity of eluate flowing through tubing or may instead be positioned to measure the radioactivity of a static (non-flowing) portion of radioactive eluate positioned adjacent the gamma detector. For example, the radioisotope generator system may include an eluate-receiving container in fluid communication with and downstream of infusion tubing in fluid communication with the outlet of a radioisotope generator. Radioactive eluate generated by the radioisotope generator can flow through the tubing and past the beta detector before discharging into the eluate-receiving container positioned adjacent the gamma detector.

[0011] The radioisotope generator system may operate in different modes in which measurements from the beta detector and / or the gamma detector are made. For example, during a quality control procedure, an infusion tubing line in fluid communication with the outlet of the radioisotope generator may be attached to the eluate-receiving container instead of a patient catheter. During this quality control procedure, the radioisotope generator may produce radioactive eluate that flows through the tubing line, past the beta detector, and into the eluate-receiving container. The beta detector may measure beta emissions from the radioactive eluate as it flows through the infusion tubing, e.g., to determine an activity level of Rb-82 in the eluate. The gamma detector may receive gamma emissions from eluate in the eluate-receiving container, e.g., to determine an activity level of Sr-82, strontium-85 (also referred to as 85Sr or Sr-85), and / or other contaminants in the eluate.

[0012] In practice, the activity level of Rb-82 in the eluate flowing through the infusion tubing line may be an order of magnitude or more greater than the activity level of any contaminants in the eluate. Accordingly, all beta emissions measured by the beta detector (including those emitted from Rb-82 and any potential contaminants, such as strontium) may be assumed to be emitted from Rb-82 present in the eluate without resolving those emissions emitted from any contaminating isotopes. To determine the activity of any suchcontaminating isotopes, the gamma emissions from a static portion of eluate in the eluate-receiving container can be measured. In some applications, the eluate is held in the eluate-receiving container for a period of time sufficient to allow Rb-82 in the eluate to substantially decay. This can reduce the amount of interfering gamma radiation (from Rb-82) measured by the gamma detector and allow the gamma detector to better detect gamma radiation emitted from contaminating radioisotopes (e.g., strontium). The activity level of one or more such contaminating radioisotopes can be determined based on the measured gamma emissions. If the activity of one or more such contaminating radioisotopes exceeds an allowable limit, the radioisotope generator system can prohibit a subsequent patient infusion procedure.

[0013] In addition to operating in a quality control mode, the radioisotope can also operate in a patient infusion mode to perform a patient infusion procedure. During the patient infusion procedure, the infusion tubing line in fluid communication with the outlet of the radioisotope generator may be attached to a patient catheter. Radioactive eluate generated by the radioisotope generator can flow through the tubing and past the beta detector. The radioisotope generator system may determine, based on the level of beta emissions measuredby the beta detector, the activity of Rb-82 in the eluate produced by the radioisotope generator. The radioisotope generator system may divert eluate initially produced by the generator to a waste container until a threshold amount of Rb-82 activity is detected in the eluate. Upon detecting a threshold amount of Rb-82 activity via the beta detector, the generator system may divert the eluate from the waste container to the patient catheter, thereby injecting or infusing the patient with the eluate containing the radioactive Rb-82.

[0014] By configuring the radioisotope generator system with both a beta detector and a gamma detector, the radioisotope generator system can provide an integrated system to help ensure the safety and accuracy of radioactive eluate generated by the system. The combination of detectors can be used to perform a variety of different radioisotope measurements and to implement corresponding control schemes and / or quality analyses based on those radioisotope measurements. Accordingly, configuring the system with multiple detectors (e.g., measuring different types of radioactive emissions) may provide more accurate resolution between different radioisotopes and / or allow activities determined using multiple detectors to be cross-checked for increased accuracy.

[0015] In some examples, a radioisotope generator system according to the disclosure is configured as a mobile cart carrying a beta detector, a gamma detector, a radioisotope generator, a controller, and associated hardware and software to execute the techniques describes herein. The radioisotope generator system may also include a shielding assembly that provides a barrier to radioactive radiation. The shielding assembly can be mounted on the mobile cart and one or more of the other components carried on the cart can be mounted in the shielding assembly.

[0016] In some configurations, the shielding assembly includes a plurality of compartments separated by one or more walls of shielding material. For example, the shielding assembly may include one compartment containing the radioisotope generator and another compartment containing the gamma detector. The compartments of the shielding assembly can be arranged to position the compartment containing the gamma detector relative to the compartment containing the radioisotope generator so as to reduce background radiation emitted by the radioisotope generator from being detected by the gamma detector. If the gamma detector is exposed to too much background radiation (e.g., radiation emitted by the contents of the generator column), the gamma detector may be saturated and / or unable to suitably detect the level of radiation emitted by an eluate sample positioned in front of the detector when evaluating the safety of the eluate. Accordingly, ensuring that the gamma detector is appropriately shielding from the radioisotope generator may help ensure the safe and efficacious operation of the entire radioisotope generator system.

[0017] In one example, an infusion system is described that includes a frame that carries a beta detector and a gamma detector and is further configured to receive a radioisotope generator that generates radioactive eluate via elution. The beta detector is positioned to measure beta emissions emitted from the radioactive eluate. The gamma detector is positioned to measure gamma emissions emitted from a portion of the radioactive eluate to evaluate the safety of the radioactive eluate delivered by the infusion system, e.g., in addition to performing other functions such as dose constancy (which may also be referred to as a constancy evaluation or constancy check).

[0018] In another example, an infusion system is described that includes a beta detector, a gamma detector, a radioisotope generator, a waste container, an eluate-receiving container, and an infusion tubing line. The beta detector is positioned to measure beta emissions emitted from radioactive liquid supplied by the radioisotope generator and flowing through the infusion tubing line. The gamma detector is positioned to measure gamma emissions emitted from a static volume of radioactive liquid received by the eluate-receiving container.

[0019] In another example, an infusion system is described that includes a movable frame, an eluant reservoir, a pump, and a radioisotope generator coupled to the eluant reservoir through the pump. The radioisotope generator is configured to generate radioactive eluate containing Rb-82 via elution of a column containing Sr-82. The example specifies that the infusion system also includes a waste container, an eluate-receiving container, and an infusion tubing circuit. The infusion tubing circuit includes an infusion tubing line, an eluate line, and a waste line. The eluate line is connected to an outlet of the radioisotope generator, the patent line is positioned to provide fluid communication between the eluate line and the eluate-receiving container, and the waste line is positioned to provide fluid communication between the eluate line and the waste container. The example also includes a beta detector and a gamma detector. The beta detector is positioned to measure beta emissions emitted from radioactive eluate generated by the radioisotope generator and flowing through the eluate line. The gamma detector is positioned to measure gamma emissions emitted from radioactive eluate generated by the radioisotope generator and received by the eluate-receiving container.

[0020] In another example, an infusion system is described that includes a movable frame, an eluant reservoir, a pump, and a radioisotope generator coupled to the eluant reservoir through the pump. The radioisotope generator is configured to generate radioactive eluate containing Rb-82 via elution of a column containing Sr-82. The example specifies that the system also includes a waste container, an eluate-receiving container, and an infusion tubing circuit. The infusion tubing circuit includes an infusion tubing line, an eluate line, and a waste line. The eluate line is connected to an outlet of the radioisotope generator, the patent line is positioned to provide fluid communication between the eluate line and the eluate-receiving container, and the waste line is positioned to provide fluid communication between the eluate line and the waste container. The example system also includes radioactive shielding, a beta detector, and a gamma detector. The radioactive shield encloses at least a portion of the infusion tubing circuit, the beta detector, and the gamma detector. The beta detector is positioned to measure beta emissions emitted from radioactive eluate generated by the radioisotope generator and flowing through the eluate line. The gamma detector is positioned to measure gamma emissions emitted from radioactive eluate generated by the radioisotope generator and received by the eluate-receiving container. The system also includes a controller in electronic communication with the beta detector and the gamma detector. The controller is configured to determine an activity of Rb-82 in the radioactive eluate based on beta emissions measured by the beta detector and determine an activity of Sr-82 and / or Sr-85 in the radioactive eluate based on gamma emissions measured by the gamma detector (e.g., by measuring gamma emissions from the decay product of Sr-82, Rb-82). The controller is further configured to control the infusion system to deliver a dose of the radioactive eluate to a patient during a patient infusion procedure.

[0021] In another example, a system is described that includes a shielding assembly that has a plurality of compartments each providing a barrier to radioactive radiation. The system includes a first compartment configured to receive a radioisotope generator that generates a radioactive eluate via elution, a second compartment configured to receive a beta detector, and a third compartment configured to receive a gamma detector.

[0022] In another example, a system is described that includes a shielding assembly that includes a plurality of compartments each providing a barrier to radioactive radiation. The system includes a first compartment configured to receive and hold a radioisotope generator that generates a radioactive eluate via elution and a second compartment configured to receive a beta detector and at least a portion of an infusion tubing circuit that is in fluid communication with the radioisotope generator. The example specifies that the beta detector is positioned to measure beta emissions emitted from radioactive eluate generated by the radioisotope generator and flowing through the portion of the infusion tubing circuit. The system also includes a third compartment configured to receive an eluate-receiving container and a gamma detector. The gamma detector is positioned to measure gamma emissions emitted from a static portion of the radioactive eluate received by the eluate-receiving container. In addition, the example states that the system includes a fourth compartment configured to receive a waste container.

[0023] In another example, an infusion system is described that includes a frame that carries a beta detector, a gamma detector, and a controller communicatively coupled to the beta detector and the gamma detector. The frame is further configured to receive a strontium-rubidium radioisotope generator that generates a radioactive eluate via elution. The example specifies that the beta detector is positioned to measure beta emissions emitted from the radioactive eluate and the gamma detector is positioned to measure gamma emissions emitted from the radioactive eluate. The example also specifies that the controller is configured to determine an activity of rubidium in the radioactive eluate based on the beta emissions measured by the beta detector and determine an activity of strontium in the radioactive eluate based on the gamma emissions measured by the gamma detector.

[0024] In another example, a method is described that includes pumping an eluant through a strontium-rubidium radioisotope generator and thereby generating a radioactive eluate via elution. The method involves conveying the radioactive eluate across a beta detector and measuring beta emissions emitted from the radioactive eluate generated by the radioisotope generator and flowing through an eluate line and determining therefrom an activity of the radioactive eluate. The method also involves receiving the radioactive eluate conveyed across the beta detector in an eluate-receiving container positioned adjacent a gamma detector. In addition, the method includes measuring gamma emissions emitted from the radioactive eluate received by the eluate-receiving container and determining therefrom an activity of strontium in the radioactive eluate in the eluate-receiving container.

[0025] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0026] FIGS. 1 and 2 are perspective and top views, respectively, of an example infusion system that can be used to generate and infuse radioactive liquid.

[0027] FIG. 3 is a rear view of the system shown in FIGS. 1 and 2 illustrating additional example features that can be included in the system.

[0028] FIGS. 4 and 5 are perspective and top views, respectively, of the system of FIGS. 1-3 shown with the cabinet structure removed for purposes of illustration and illustrating an example shielding assembly arrangement.

[0029] FIG. 6 is a block diagram illustrating an example arrangement of components that can included in the system of FIGS. 1-5 to generate radioactive eluate and detect radioactive emissions.

[0030] FIGS. 7 A and 7B are perspective views of an example configuration of the shielding assembly from FIGS. 4 and 5 shown removed from the cart frame for purposes of illustration.

[0031] FIG. 7C is a perspective view of the example shielding assembly from FIGS. 7A and7B shown sectionalized along the A-A sectional line indicated on FIG. 7A.

[0032] FIG. 7D is a side view of the example shielding assembly from FIGS. 7A and 7B shown sectionalized along the B-B sectional line indicated on FIG. 7A.

[0033] FIG. 7E is a top view of the example shielding assembly from FIGS. 7A and 7B illustrating an example arrangement of compartments in which a radiation path passes through one or more sidewall sections defining the compartments.

[0034] FIG. 7F is exploded view of a portion of the example shielding assembly from FIG. 7D showing an example arrangement of an eluate-receiving container relative to a gamma detector.

[0035] FIG. 8 is a flow diagram of an example technique that may be used to perform a patient infusion procedure to infuse radioactive liquid into a patient.

[0036] FIG. 9 is a flow diagram of an example technique that may be used to perform a quality control procedure.

[0037] FIGS. 10-16 describe exemplary calibration and quality control test that may be periodically performed on an infusion system according to the disclosure.DETAILED DESCRIPTION

[0038] In general, the disclosure relates to systems, components, and techniques for generating radioactive liquids, infusing radioactive liquids into patients, and ensuring the safety, accuracy, and quality of the radioactive liquids so generated. The described systems, components, and techniques can be implemented to detect and quantify multiple different radioisotopes. In some examples, a system includes multiple detectors positioned at different locations along the fluid pathway from a radioisotope source to measure one or more radioisotopes present in the fluid provided by the radioisotope source. The radioactive emissions detected and measured by the multiple detectors, alone or in combination, can be used to determine the activity of one or more radioisotopes present in the system. If the system determines that the activity of one or more radioisotopes is within allowable limits, the system may permit and control delivery of radioactive liquid from the radioisotope source to a patient. By contrast, if the system determines that the activity of one or more radioisotopes is outside of an allowable limit, for example during a quality control procedure, the system may prevent infusion into a patient during a subsequent patient infusion procedure until the issue is resolved.

[0039] In some examples described herein, a radioisotope generator system includes a beta detector and a gamma detector positioned downstream of the radioisotope generator that generates radioactive eluate via elution. During a patient infusion procedure, an infusion tubing circuit can connect an outlet of the radioisotope generator to a patient catheter. The infusion tubing circuit can be positioned adjacent the beta detector such that, as eluate flows through the infusion tubing circuit, the eluate passes over the beta detector. Beta emissions emitted by the eluate can be detected by the beta detector and the activity of a radioisotope associated with those beta emissions determined.

[0040] To execute a quality control procedure, the infusion tubing circuit can be connected to an eluate-receiving container instead of a patient catheter. The eluate-receiving container may be a vessel positioned adjacent to the gamma detector such that gamma emissions emitted by eluate received in the container can be detected by the gamma detector. During operation, an amount of eluate sufficient to partially or fully fill the eluate-receiving container can be generated and supplied to the eluate-receiving container. The gamma detector can then measure gamma emissions emitted by the eluate in the receiving container, e.g., to determine the activity of one or more radioisotopes present in the eluate. In some applications, beta emissions measured by the beta detector are used to determine the activity of Rb-82 in the eluate while gamma emissions measured by the gamma detector are used to determine the activity of contaminants such as strontium in the eluate.

[0041] A multi-detector system that facilitates measurement of different types of radioactive decay products from the same radioactive liquid sample may be integrated with the radioisotope generator that produces the radioactive liquid so measured. This can provide an integrated system for convenient use in, and deployment to, different clinical locations. For example, an integrated system, which may or may not be mobile, can include a frame that carries a beta detector and a gamma detector and is further configured to receive a radioisotope generator that generates radioactive eluate via elution. The beta detector can be supported on the frame either directly or indirectly, e.g., via radioactive shielding material.Similarly, the gamma detector can be supported on the frame either directly or indirectly, e.g., also via radioactive shielding material. The beta detector and the gamma detector can be positioned to measure beta and gamma emissions, respectively, from radioactive eluate discharged from the radioisotope generator. For example, the gamma detector can be positioned to measure gamma emissions from a portion of the radioactive eluate that allows for the safety of the radioactive eluate delivered by the overall infusion system to be evaluated. An infusion system can have a variety of features, functionalities, and components as described herein.

[0042] FIGS. 1 and 2 are perspective and top views, respectively, of an example infusion system 10 that can be used to generate and infuse radiopharmaceutical liquid. In the illustrated example, system 10 includes a cabinet structure 12 mounted on wheels 14 so as to be movable. System 10 also includes a user interface 16 that can be electronically and / or communicatively coupled to a controller that controls the operation of the infusion system. As described in greater detail below, cabinet structure 12 may house a radioisotope generator and multiple detectors configured to detect radioactive decay products, such as beta emissions and gamma emissions. In operation, the radioisotope generator may generate radioactive eluate via elution with an eluant. The eluate may be delivered proximate a beta detector to measure beta emissions emanating from the eluate and / or proximate a gamma detector to measure gamma emissions emanating from the eluate. A controller associated with system 10 may control operation of the system based on the measured beta emissions and / or measured gamma emissions.

[0043] Cabinet structure 12 may be a shell or a housing that defines an interior space configured to contain various components of system 10. For example, cabinet structure 12 may be configured (e.g., sized and / or shaped) to contain a shielding assembly in which radioactive materials of system 10 are contained, a pump to pump liquid through a radioisotope generator in the cabinet structure, a controller that controls operation of system 10, and / or other components of the system. Cabinet structure 12 may be fabricated from durable polymeric materials, light weight metals, or other suitable materials. In some examples, cabinet structure is fabricated from a radiation-resistant or impregnated polymeric material to prevent degradation of the cabinet structure in the event that radioactive liquid is inadvertently spilled on the cabinet structure.

[0044] Cabinet structure 12 may include one or more openings, doors, and / or removable portions to access an interior of the cabinet structure and components contained therein. In the illustrated example, cabinet structure 12 includes an opening 18 formed in the uppersurface of the structure through which a portion of a shielding assembly extends and is accessible. As will be discussed in greater detail below, the portion of the shielding assembly extending through opening 18 may include a door to access a compartment that receives a portion of an infusion tubing circuit and / or a door to access a compartment into which an eluate-receiving container is inserted. As further illustrated, cabinet structure 12 may include a removable portion 20 that can be removed from a remainder of the cabinet structure to access an interior of the structure. In some examples, removable portion 20 provides access to a door of a shielding assembly compartment containing a radioisotope generator.

[0045] In the example of FIGS. 1 and 2, cabinet structure 12 is mounted on wheels 14.Wheels 14 may be useful to allow system 10 to be easily moved from one location to another location, e.g., to perform patient infusion procedures in different locations or to perform maintenances or repair tasks. To prevent system 10 from inadvertently moving after being positioned in a desired location, the system may include a brake system that prevents the system from being moved when engaged. As shown in FIG. 2, system 10 includes a brake system the includes at least one peddle mounted at the rear end of the cabinet structure, which is illustrated as including a first peddle 20A to engage the brake system and a second peddle 20B to disengage the brake system. The peddles 20A and 20B can be operatively connected to a mechanical interlock, friction pad, or other structure that, once engaged, inhibits movement of system 10. Pushing first peddle 20A downwardly with respect to gravity can engage the brake system while pushing second peddle 20B downwardly with respect to gravity can disengage the brake system. In other configurations, system 10 may only have a single break peddle that is pressed to both engage and disengage the break system, a hand control to engage and disengage the break system, or yet other engagement feature. When configured with multiple brake pedals as shown in FIG. 2, the pedals can be color indexed to indicate engagement (e.g., red for stop) and disengagement (e.g., green for go).

[0046] As mentioned above, system 10 also includes user interface 16. User interface 16 may include a display screen as illustrated or other output media, and user input media. For example, user interface may include a keyboard, mouse, depressible buttons, switches, and / or touch screen interface. In some examples, user interface 16 may be configured to provide visual, audible, and / or tactile feedback to a user. User interface 16 may be communicatively coupled (e.g., via a wired or wireless connection) to a controller that controls the operation of system 10. A clinician or other user may interact with system 10 through user interface 16, e.g., to change or establish the parameters of a patient infusion procedure, change or establish the parameters of a quality control procedure, view historical or maintenance information, or otherwise interact with system 10. In one example, user interface 16 is implemented as a touchscreen having a screen that a user can physically touch to communicate with system 10.

[0047] In the illustrated example, user interface 16 is shown as a display or touch screen mounted on a pole extending vertically from cabinet structure 12. When so configured, user interface 16 may be rotatably coupled to the mounting pole so as to be swiveled to any rotational position desired by a user and / or translated to different vertical positions. While user interface 16 is illustrated as being physically attached to cabinet structure 12, in other applications, user interface 16 may be physically separated from the cabinet structure. For example, user interface 16 may be provided through a mobile communication device (e.g., smart phone, tablet computer) or otherwise physically separate from cabinet structure 12 and communicatively coupled to components contained therein.

[0048] System 10 can include a variety of other features and functionalities. FIG. 3 is a rear view of system 10 shown in FIGS. 1 and 2 illustrating additional example features that can be included on the system. In this example, system 10 includes a handle 22 extending outwardly from cabinet structure 12 to provide a surface that an operator can grasp to move the system from one location to another location. System 10 also includes a power connection 24. In different examples, system 10 may be powered via a wired connection to wall or mains power, via a rechargeable battery, or through a combination of power sources. Power connection 24 may be a socket to which an electrical cable can be connected or may be an electrical cable, for example that is retractable inside of cabinet structure 12, to enable connection to an external power source. Power delivered to system 10 via power connection 24 may be used to directly power the various electrical components of the system, such as a controller and / or pump, or may provide power to a battery contained within cabinet structure 12 that then powers the various components of the system.

[0049] In some examples, system 10 may also include a printer 26 that can provide printed summaries, reports, or other printed media relating to system 10. For example, printer 26 may be used to generate patient reports containing data related to a specific patient infusion procedure undertaken. The patient report may be incorporated into a patient's file, shared with the caregiver, or otherwise used to document care delivered using the infusion system. As another example, printer 26 may be used to generate maintenance reports indicating the status of one or more components within system 10, document maintenance undertaken on the system, or otherwise record action taken on the system. Printer 26 can becommunicatively coupled to a controller that controls the overall operation of system 10. In some examples, an operator may interact with the user interface 16 to request one or more reports or other printed outputs be generated using printer 26.

[0050] Although handle 22, power connection 24, and printer 26 are illustrated as being positioned on the rear side of cabinet structure 12 in the configuration of FIG. 3, it should be appreciated that the features may be positioned at other locations on system 10 while still providing the functionality described herein.

[0051] As briefly discussed above, system 10 may include a shielding assembly that blocks radioactive radiation emitted by radioactive materials within the system. FIGS. 4 and 5 are perspective and top views, respectively, of system 10 from FIGS. 1-3 shown with cabinet structure 12 removed for purposes of illustration and illustrating an example shielding assembly arrangement. As shown in this example, system 10 includes a shielding assembly 28 carried by a frame 30. In particular, in the illustrated configuration, shielding assembly 28 is mounted to a shielding assembly frame 32 which, in turn, is mounted to a cart frame 30.

[0052] In general, frame 30 may be any rigid structure that defines a surface configured (e.g., sized and / or shaped) to receive and hold shielding assembly 28. Frame 30 may have one or more horizontally oriented members 34 on which a bottom surface of shielding assembly 28 rests when the shielding assembly is inserted onto the frame. In some examples, frame 30 also includes one or more vertically extending members that extend along sidewalls of shielding assembly 28, when the shielding assembly is installed in the frame. For example, as illustrated in the configuration of FIG. 4, shielding assembly 28 includes a first vertical wall surface 36A, a second vertical wall surface 36B, and a rear vertical wall surface 36C that collectively define an opening configured to receive and surround around at least a portion of shielding assembly 28. Configuring system 10 with frame 30 can be useful to provide a structure that supports shielding assembly 28 and / or helps protect the shielding assembly from damage or inadvertent physical contact. In the illustrated configuration, wheels 14 are operatively (e.g., mechanically) connected to frame 30 and, more particularly, horizontally oriented member 34 of the frame. In other examples as indicated above, system 10 does not include wheels 14.

[0053] In some examples, a pump that pumps liquid through system 10 is carried by frame 30 inside of cabinet structure 12 (in examples in which system 10 includes an additional exterior cabinet structure). For example, with reference to FIG. 5, frame 30 defines a space 38 offset from shielding assembly 28 that is configured to receive a pump 40. In particular, with the illustrated example, space 38 is positioned between a second vertical wall surface 36B of frame 30 and shielding assembly 28, when the shielding assembly is installed on the frame.Space 38 can be configured (e.g., sized and / or shaped) to receive pump 40 and / or other components of system 10 such as a controller, one or more servomotors to control valves, or other operational hardware to enable system 10 to provide the functions described herein. Such an arrangement may be useful to co-locate hardware components of system 10 not in direct contact with radioactive materials with other components contained in shielding assembly 28 that are in direct contact with radioactive emissions emitted by radioactive liquid generated using the system.

[0054] In FIGS. 4 and 5, shielding assembly 28 is mounted to shielding assembly frame 32 which, in turn, can be installed on frame 30 that defines a mobile cart frame. For example, shielding assembly 28 may be physically and / or mechanically connected to shielding assembly frame 32, such that the shielding assembly is in direct physical contact with the shielding assembly frame. In turn, shielding assembly frame 32 can be received in a space defined by horizontally oriented member 34 and vertically oriented sidewalls 36A-C, e.g., such that the shielding assembly frame 32 is in physical contact with frame 30. Shielding assembly frame 32, similar to frame 30, maybe a rigid structure that surrounds and or encloses at least a portion of the sidewalls of shielding assembly 28. For example, shielding assembly frame 32 may provide mechanical rigidity and / or support for shielding assembly 28 to allow the shielding assembly to be transported outside of system 10.

[0055] To enable efficient installation of shielding assembly 28 onto frame 30, shielding assembly frame 32 may include multiple hooks 42 positioned about a perimeter of the shielding assembly that can be engaged by a lifting device to lift shielding assembly frame 32, and the shielding assembly carried 28 thereon, for installation onto cart frame 30. During assembly or maintenance, an operator may attach a lifting mechanism such as a crane or block and tackle to hooks 42 to enable shielding assembly 28 to be lifted and installed on cart frame 30. Pump 40 and other components of system 10 carried by frame 30 outside of shielding assembly 28 may or may not also be physically attached to shielding assembly frame 32. In some examples, shielding assembly frame 32 carries only shielding assembly 28 and does not carry other components that are received on frame 30 adjacent to shielding assembly 28, such as pump 40, a controller controlling the operation of system 10, and other related hardware or software.

[0056] When system 10 includes frame 30 and / or shielding assembly frame 32, each frame may typically be made of a rigid material such as a rigid metal or plastic that provide structural integrity to the overall system. While FIGS. 4 and 5 illustrate one example arrangement of respective frames that can receive various hardware components of system10, it should be appreciated that in other configurations, system 10 does not include a separate shielding assembly frame and cart frame, or may have a different configuration or arrangement of frame members than that illustrated.

[0057] Shielding assembly 28 and frame 30 can receive and hold various components of system 10 that enable the system to perform the functions attributed to it herein. For example, as briefly indicated above, system 10 may include a radioisotope generator that generates radioactive eluate via an elution with an eluant. The system may include a radioisotope generator that contains radioactive material in order to generate the radioactive eluate via elution. The system may also include multiple detectors, such as a beta detector and a gamma detector, positioned downstream of the radioisotope generator to measure radioactive emissions emitted by radioactive eluate produced using the generator.

[0058] FIG. 6 is a block diagram illustrating an example arrangement of components that can included in system 10 to generate radioactive eluate and detect radioactive emissions. In the example, system 10 includes an eluant reservoir 50, previously-described pump 40, a radioisotope generator 52, a waste container 54, an eluate-receiving container 56, a beta detector 58, and a gamma detector 60. One or more fluid tubing lines can connect the various components of system 10 together.

[0059] For example, in the configuration of FIG. 6, pump 40 receives eluant from eluant reservoir 50, pressurizes the eluant, and discharges pressurized eluant into an eluant line 62. A first diverter valve 64 controls the flow of eluant to one of a radioisotope generator inlet line 66 and a radioisotope generator bypass line 68. Eluant flowing through radioisotope generator bypass line 68 bypasses radioisotope generator 52 and can flow directly into an infusion tubing line 70. Infusion tubing line 70 can be in fluid communication with either eluate-receiving container 56 (e.g., during a quality control procedure) or a patient catheter 72 (e.g., during a patient infusion procedure). A second multi-way valve 74 controls a flow of eluate generated by elution within radioisotope generator 52 and received from a radioisotope generator discharge line 75 to either the infusion tubing line 70 or a waste line 76. Waste line 76 can be connected to waste container 54.

[0060] During operation, radioisotope generator 52 can generate radioactive eluate via elution. For example, radioisotope generator 52 may be a strontium-rubidium generator containing Sr-82 bound on a support material, such as stannic oxide or tin oxide. Rb-82 is a daughter decay product of Sr-82 and binds less strongly to the support material than the strontium. As pressurized eluant from eluant reservoir 50 is passed through the radioisotope generator, the eluant may release Rb-82 so as to generate a radioactive eluate. For example, when the eluant is a saline (NaCl) solution, sodium ions in the saline can displace Rb-82 in the generator so as to elute a Rb-82 chloride solution.

[0061] In other examples, radioisotope generator 52 can generate different types of decay products besides Rb-82. The type of daughter decay product produced by radioisotope generator 52 can be controlled by selecting the type of radioisotope loaded onto the generator support material. Example types of radioisotope generators that can be used as radioisotope generator 52 include, but are not limited to, 99Mo / 99mTc (parent molybdenum-99 bound on a support material to produce daughter decay product technetium-99m); 90Sr / 90Y (parent strontium-90 bound on a support material to produce daughter decay product yttrium-90); 188W / 188Re (parent tungsten-188 bound on a support material to produce daughter decay product rhenium- 188); and 68Ge / 68Ga (parent germanium-68 bound on a support material to produce daughter decay product gallium-68). Yet other types of radioisotope generators that can be used as radioisotope generator 52 include: 42Ar / 42K; 44Ti / 44Sc; 52Fe / 52mMn; 72Se / 72As; 83Rb / 83mKr; 103Pd / 103mRh; 109Cd / 109mAg; 113Sn / 113mIn; 118Te / 118Sb; 132Te / 132I; 137Cs / 137mBa; 140Ba / 140La; 134Ce / 134La; 144Ce / 144Pr; 140Nd / 140Pr; 166Dy / 166Ho; 167Tm / 167mEr; 172Hf / 172Lu;178w / 178Ta. 1 10s / 191mIr. 1 4(^19^. 226Ra / 222Rn; ^ 225^213^

[0062] To measure the radioactivity of one or more radioisotopes in the radioactive eluate generated via elution in system 10, the system may include multiple detectors configured to receive and measure different radioactive emissions produced by the radioactive eluate. For example, as shown in the example of FIG. 6, system 10 may include a beta detector 58 and a gamma detector 60. Beta detector 58 can be positioned downstream of radioisotope generator 52 to measure beta emissions emitted by radioactive eluate produced by the generator. Gamma detector 60 can also be positioned downstream of radioisotope generator 52 to measure gamma emissions emitted by the radioactive eluate produced by the generator.

[0063] The specific locations of beta detector 58 and gamma detector 60 can vary. However, in the example of FIG. 6, beta detector 58 is positioned between an outlet of radioisotope generator 52 and second multi-way valve 74, which is upstream of waste container 54 and infusion tubing 70 along the fluid pathway from the radioisotope generator. By contrast, gamma detector 60 is positioned downstream of the outlet of the radioisotope generator 52 and beta detector 58. For example, gamma detector 60 may be positioned downstream of the second multi-way valve 74 along the fluid pathway of infusion tubing 70.

[0064] In operation, beta detector 58 can measure beta emissions emitted by radioactive eluate generated by and discharged from radioisotope generator 52. In some examples, beta detector 58 is positioned in close proximity to radioisotope generator discharge line 75 such that the beta detector can detect beta emissions emitted from radioactive eluate present in the discharge line. The radioactive eluate may be flowing through the radioisotope generator discharge line 75 toward infusion tubing 70 and / or waste line 76. Alternatively, the radioactive eluate may be supplied to the radioisotope generator discharge line 75 and held static (non-flowing) while the beta detector 58 measures beta emissions emitted from the radioactive eluate. In yet other configurations, an eluate-receiving reservoir may be provided in fluid communication with radioisotope generator discharge line 75, for example via an additional multi-way valve, and beta detector 58 positioned to measure beta emissions from the radioactive eluate supplied to the eluate-receiving reservoir. In any configuration, beta detector 58 may measure beta emissions from radioactive eluate generated by the generator in order to detect and / or quantify one or more radioisotopes present in the radioactive eluate.

[0065] System 10 also includes a gamma detector 60. In operation, gamma detector 60 can measure gamma emissions emitted by radioactive eluate generated by and discharged from radioisotope generator 52. For example, radioactive eluate generated by radioisotope generator 52 may be discharged through radioisotope generator discharge line 75, diverter valve 74, infusion tubing 70, and supplied to eluate-receiving container 56. Gamma detector 60 may be positioned in close proximity to eluate-receiving container 56 in order to detect gamma emissions emitted by the portion of radioactive eluate delivered to the receiving container. For example, a clinician may attach an outlet of infusion tubing 70 to an inlet of eluate-receiving container 56 in order to supply radioactive eluate to the receiving container. Upon subsequently controlling pump 40 to generate radioactive eluate that is supplied to the eluate-receiving container 56, gamma detector 60 may measure gamma emissions emitted by the radioactive eluate.

[0066] While FIG. 6 illustrates one example location for gamma detector 60, other locations may be used. For example, gamma detector 60 may be positioned in close proximity to a tubing line downstream of radioisotope generator 52, such as radioisotope generator discharge line 75 and / or infusion tubing 70. In these examples, gamma detector may measure gamma emissions emitted by radioactive eluate flowing through the tubing line or a static (non-flowing) portion of radioactive eluate held within the tubing line. Independent of the specific location of the gamma detector with in system 10, gamma detector 60 may measure gamma emissions from radioactive eluate generated by the radioisotope generator 52 in order to detect and / or quantify one or more radioisotopes present in the radioactive eluate.

[0067] For example, gamma emissions measured by gamma detector 60 may be used to detect and / or quantify one or more contaminating radioisotopes in radioactive eluategenerated by radioisotope generator 52, while beta emissions measured by beta detector 58 may be used to detect and / or quantify one or more radioisotopes in the radioactive eluate targeted for patient infusion. In some examples, beta detector 58 measures beta emissions from radioactive eluate flowing through radioisotope generator discharge line 75 toward eluate-receiving container 56. Once the radioactive eluate has passed beta detector 58 and filled eluate-receiving container 56, either partially or fully, gamma detector 60 may measure gamma emissions from that portion of radioactive eluate supplied to the receiving container. In these applications, gamma detector 60 may measure gamma emissions from a portion of radioactive eluate also emitting beta emissions which were detected by beta detector 58 as the radioactive eluate flowed towards the eluate-receiving container 56. In other operational configurations, beta detector 58 and gamma detector 60 may not measure radioactive emissions from the same portion or volume of radioactive eluate but may measure radioactive emissions from different portions of radioactive eluate.

[0068] Radioisotope generator system 10 in the example of FIG. 6 also includes a controller 80. Controller 80 may be communicatively coupled (e.g., via a wired or wireless connection) to the various pump(s), valves, and other components of system 10, including beta detector 58 and gamma detector 60, so as to send and receive electronic control signals and information between controller 80 and the communicatively coupled components. For example, controller 80 may receive data generated by beta detector 58 indicative of the magnitude of beta emissions detected by the detector. Controller 80 may further receive data generated by gamma detector 60 indicative of the amount and type (e.g., spectral distribution) of gamma emissions detected by the detector. Controller 80 may further process the data to determine an activity of different isotopes in the eluate from which beta detector 58 and gamma detector 60 detected beta emissions and gamma emissions, respectively. Controller 80 may also manage the overall operation of radioisotope generator system 10, including initiating and controlling patient dosing procedures, controlling the various valves and pump(s) in the system, receiving and processing signals from beta detector 58 and gamma detector 60, and the like.

[0069] In operation, beta detector 58 can detect beta emissions emanating from radioactive eluate positioned in front of the detector. Beta detector 58 can include a variety of components to detect and process beta emission signals. In some configurations, beta detector 58 is implemented using a solid-state detector element such as a PIN photodiode. In these configurations, the solid-state detector element can directly convert impinging radioactive energy into electrons in the semiconductor material of the detector. The electrons can then be amplified into a usable signal (e.g., received by controller 80). In some examples, beta detector 58 includes a scintillator, which converts impinging radioactive energy into light pulses, which is then captured by an attached photon-to-electron converter such as a photomultiplier tube or avalanche photodiode. The choice of the scintillator can determine the sensitivity and the countrate performance. For example, beta detector 58 may be implemented using a plastic scintillator when high sensitivity and high countrate performance are desired.

[0070] During operation, gamma detector 60 can detect gamma ray emissions emanating from a portion of eluate positioned in close proximity to the detector, e.g., statically positioned in eluate-receiving container 56. Gamma detector 60 may include a variety of different components to detect and process gamma ray radiation signals, such as a pulse sorter (e.g., multichannel analyzer), amplifiers, rate meters, peak position stabilizers, and the like. In one example, gamma detector comprises a scintillation detector. In another example, gamma detector comprises a solid-state semiconductor detector.

[0071] The specific type of gamma detector selected for detector 60 can vary based on a variety of factors such as, e.g., the required resolution of the detector, the physical requirements for practically implementing the detector in a system (e.g., coolingrequirements), the expected sophistication of the personnel operating the detector, and the like. In some applications, gamma detector 60 is a scintillator-type detector, such as a comparatively low-resolution alkali halide (e.g., Nal, Csl) or bismuth germanate (e.g., Bi4Ge3012, or BGO). In other applications, gamma detector 60 incorporates a higher-Z metallic species. An example is lutetium oxyorthosilicate, Lu2(Si04)0(Ce) or LSO, which, though slightly better in resolution than BGO, may have limited applicability because of its relatively high intrinsic radiation. As another example, gamma detector 60 may be a cerium-doped lanthanum, such as LaC13(Ce) or LaBr3(Ce).

[0072] In other applications, gamma detector 60 is a solid-state semiconductor-type detector, such as a planar germanium detector. For instance, as another example, gamma detector 60 may be a solid-state semiconductor-type telluride detector, such as cadmium-telluride or cadmium-zinc-telluride semiconductor detector. Gamma detector 60 may be operated at room (ambient) temperature or may be cooled below room temperature (e.g., by a cooling device incorporated into radioisotope generator system 10) to increase the resolution of detector.

Claims

CLAIMS:An infusion system comprising:a frame that carries a beta detector and a gamma detector and is further configured to receive a radioisotope generator that generates radioactive eluate via elution,wherein the beta detector is positioned to measure beta emissions emitted from the radioactive eluate, andthe gamma detector is positioned to measure gamma emissions emitted from a portion of the radioactive eluate to evaluate a safety of the radioactive eluate delivered by the infusion system.

2. The infusion system of any claim herein, wherein the gamma detector is positioned to evaluate the safety of the radioactive eluate to ensure that radioactive eluate generated by the radioisotope generator is safe for patient infusion.

3. The infusion system of any claim herein, further comprising an infusion tubing line configured to receive the radioactive eluate, either directly or indirectly, from the radioisotope generator, when the radioisotope generator is received by the frame.

4. The infusion system of any claim herein, further comprising an eluate-receiving container in fluid communication with the infusion tubing line to receive the portion of the radioactive eluate, thereby providing a static portion of radioactive liquid for evaluation by the gamma detector.

5. The infusion system of any claim herein,wherein the beta detector is positioned to measure beta emissions emitted from radioactive eluate flowing through the infusion tubing line; andthe gamma detector is positioned to measure gamma emissions emitted from the portion of radioactive eluate received by the eluate-receiving container.

6. The infusion system of any claim herein, wherein the eluate-receiving container comprises a vial, the infusion tubing line comprises a needle at its end, and the needle on the infusion tubing line is inserted into the vial.

7. The infusion system of any claim herein, further comprising a waste container.

8. The infusion system of any claim herein, whereininfusion tubing line is part of an infusion tubing circuit that includes an eluate line, a waste line, and a multi-way divergence valve,when the radioisotope generator is received by the frame, the infusion tubing line is in fluid communication with the eluate line via the multi-way divergence valve and the waste line is in fluid communication with the eluate line via the multi-way divergence valve,the infusion tubing line is connected to the eluate-receiving container, and the waste line is connected to the waste container.

9. The infusion system of any claim herein, further comprising a cabinet structure housing at least the radioisotope generator, the infusion tubing circuit, the eluate-receiving container, the beta detector, and the gamma detector.

10. The infusion system of any claim herein, wherein the cabinet structure has a top surface having an opening formed therein through which the eluate-receiving container is configured to be removed and inserted.

11. The infusion system of any claim herein, wherein the cabinet structure has a door configured to selectively open and close to provide access to the eluate-receiving container.

12. The infusion system of any claim herein, wherein the door is configured to open upwardly with respect to gravity.

13. The infusion system of any claim herein, further comprising the radioisotope generator received by the frame.

14. The infusion system of any claim herein, wherein the radioisotope generator is a strontium-rubidium radioisotope generator configured to generate radioactive eluate containing rubidium-82 via elution of a column containing strontium-82.

15. The infusion system of any claim herein, further comprising a controller in electronic communication with the gamma detector, wherein the controller is configured to determinean activity of strontium in the portion of radioactive eluate based on the gamma emissions measured from the portion of radioactive eluate.

16. The infusion system of any claim herein, wherein the controller is configured to determine an activity of at least one of strontium-82 and strontium-85 in the portion of radioactive eluate and evaluate the safety of the radioactive eluate based on the determined activity.

17. The infusion system of any claim herein, wherein the controller is configured to prevent a patient infusion procedure if the determined activity of at least one of strontium-82 and strontium-85 exceeds an allowable limit.

18. The infusion system of any claim herein, further comprising a touchscreen in communication with the controller.

19. The infusion system of any claim herein, further comprising radioactive shielding surrounding the beta detector, the gamma detector, and the radioisotope generator, when the radioisotope generator is received by the frame, the radioactive shielding providing a barrier effective to reduce radiation emitted by the radioisotope generator and the radioactive eluate below a limit allowable for operating personnel.

20. The infusion system of any claim herein, wherein the radioactive shielding comprises a shielding assembly having a plurality of compartments, including a compartment containing the beta detector, a compartment containing the gamma detector, and a compartment containing the radioisotope generator.

21. The infusion system of any claim herein, wherein the frame carries the beta detector and the gamma detector and also receives the radioisotope generator by supporting the shielding assembly which, in turn, is configured to contain the beta detector, the gamma detector, and the radioisotope generator.

22. The infusion system of any claim herein, wherein the radioisotope generator, the beta detector, and the gamma detector are not positioned in a same plane either vertically orhorizontally to maximize a distance between the radioisotope generator and the gamma detector.

23. The infusion system of any claim herein, wherein the gamma detector is positioned at a higher elevation than the radioisotope generator and the beta detector is positioned between the radioisotope generator and the gamma detector, when the radioisotope generator is received by the frame.

24. The infusion system of any claim herein, further comprising an eluate-receiving container positioned over the gamma detector.

25. The infusion system of any claim herein, wherein the eluate-receiving container has a capacity ranging from 10 milliliters to 100 milliliters.

26. The infusion system of any claim herein, wherein a bottom surface of the eluate-receiving container is spaced a distance ranging from 10 to 30 millimeters from the gamma detector.

27. The infusion system of any claim herein, further comprising a removable insert having a closed bottom surface positionable between the gamma detector and the eluate-receiving container.

28. The infusion system of any claim herein, wherein the gamma detector comprises a solid state gamma detector coupled to a multi-channel analyzer and the beta detector comprises a scintillator and photomultiplier.

29. The infusion system of any claim herein, wherein the frame is mounted on wheels so as to be movable.

30. An infusion system comprising:a beta detector;a gamma detector;a radioisotope generator;a waste container;an eluate-receiving container; andan infusion tubing line,wherein the beta detector is positioned to measure beta emissions emitted from radioactive liquid supplied by the radioisotope generator and flowing through the infusion tubing line; andthe gamma detector is positioned to measure gamma emissions emitted from a static volume of radioactive liquid received by the eluate-receiving container.

31. The infusion system of any claim herein, wherein the radioisotope generator is a strontium-rubidium radioisotope generator configured to generate radioactive eluate containing rubidium-82 via elution of a column containing strontium-82.

32. The infusion system of any claim herein, wherein the gamma detector is positioned to evaluate the safety of the radioactive liquid in the eluate-receiving container to ensure that radioactive liquid generated by the radioisotope generator is safe for patient infusion.

33. The infusion system of any claim herein, wherein the infusion tubing is part of an infusion tubing circuit that includes an eluate line coupled to the radioisotope generator, an infusion tubing line downstream of the eluate line and coupled to the eluate-receiving container, and a waste line downstream of the eluate line and coupled to the waste container.

34. The infusion system of any claim herein, further comprising:an eluant reservoir;a pump coupled to the eluant reservoir via an eluant line, the pump being configured to pump eluant from the eluant reservoir through the radioisotope generator, thereby generating the radioactive liquid via elution.

35. The infusion system of any claim herein, wherein the beta detector is positioned to measure beta emissions from radioactive liquid flowing through the eluate line toward the eluate-receiving container and filling the eluate-receiving container to provide the static volume of radioactive liquid for evaluation by the gamma detector.

36. The infusion system of any claim herein, wherein the eluate-receiving container comprises a vial, the eluate line comprises a needle, and the needle on the eluate line is inserted into the vial.

37. The infusion system of any claim herein, further comprising a controller in electronic communication with the gamma detector, wherein the controller is configured to determine an activity of strontium in the portion of radioactive eluate based on the gamma emissions measured from the portion of radioactive eluate.

38. The infusion system of any claim herein, wherein the controller is configured to determine an activity of at least one of strontium-82 and strontium-85 in the portion of radioactive eluate and evaluate the safety of the radioactive eluate based on the determined activity.

39. The infusion system of any claim herein, wherein the controller is configured to prevent a patient infusion procedure if the determined activity of at least one of strontium-82 and strontium-85 exceeds an allowable limit.

40. The infusion system of any claim herein, further comprising radioactive shielding surrounding at least the beta detector, the gamma detector, the radioisotope generator, the waste container, and the eluate-receiving container, the radioactive shielding providing a barrier effective to reduce radiation emitted by the radioisotope generator and the radioactive eluate below a limit allowable for operating personnel.

41. The infusion system of any claim herein, wherein the radioactive shielding includes at least one opening through which the eluate-receiving container is configured to be removed and inserted.

42. The infusion system of any claim herein, wherein the shielding assembly further comprises at least one door configured to selectively open and close to provide access to the eluate-receiving container.

43. The infusion system of any claim herein, wherein the gamma detector is positioned at a higher elevation than the radioisotope generator and the beta detector is positioned between the radioisotope generator and the gamma detector, when the radioisotope generator is received by the frame.

44. The infusion system of any claim herein, wherein a bottom surface of the eluate-receiving container is spaced a distance ranging from 10 to 30 millimeters from the gamma detector.

45. The infusion system of any claim herein, wherein the eluate-receiving container has a capacity ranging from 10 milliliters to 100 milliliters.

46. The infusion system of any claim herein, further comprising a removable insert having a closed bottom surface positionable between the gamma detector and the eluate-receiving container.

47. The infusion system of any claim herein, further comprising a frame mounted on wheels so as to be movable, wherein the frame supports the beta detector, the gamma detector, the radioisotope generator, the waste container, the eluate-receiving container, and the infusion tubing line.

48. An infusion system comprising:a movable frame;a pump;a radioisotope generator coupled to the eluant reservoir through the pump, the radioisotope generator being configured to generate radioactive eluate containing rubidium-82 via elution of a column containing strontium-82;an infusion tubing circuit that includes an infusion tubing line, an eluate line, and a waste line, the eluate line being connected to an outlet of the radioisotope generator, the infusion tubing line positioned to provide fluid communication between the eluate line and the eluate-receiving container, and the waste line being positioned to provide fluid communication between the eluate line and the waste container;a beta detector positioned to measure beta emissions emitted from radioactive eluate generated by the radioisotope generator and flowing through the eluate line; anda gamma detector positioned to measure gamma emissions emitted from radioactive eluate generated by the radioisotope generator and received by the eluate-receiving container.

49. The infusion system of any claim herein, further comprising radioactive shielding enclosing at least a portion of the infusion tubing circuit, the beta detector, and the gamma detector.

50. The infusion system of any claim herein, wherein the radioactive shielding also encloses the eluate-receiving container and the waste container.

51. The infusion system of any claim herein, wherein the eluate-receiving container is positioned coaxially with and vertically above the gamma detector.

52. The infusion system of any claim herein, wherein a bottom surface of the eluate-receiving container is positioned a distance ranging from 10 to 30 millimeters above the gamma detector, and the eluate-receiving container has a capacity ranging from 10 milliliters to 100 milliliters.

53. The infusion system of any claim herein, wherein the eluate-receiving container comprises a vial, the eluate line comprises a needle at its end, and the needle on the eluate line is inserted into the vial.

54. The infusion system of any claim herein, further comprising a removable insert having a closed bottom surface positionable between the gamma detector and the eluate-receiving container to hold the eluate-receiving container at a fixed orientation with respect to the gamma detector.

55. The infusion system of any claim herein, further comprising a controller in electronic communication with the beta detector and the gamma detector, wherein the controller is configured to determine an activity of rubidium-82 in the radioactive eluate based on beta emissions measured by the beta detector and determine an activity of strontium-82 in the radioactive eluate based on gamma emissions measured by the gamma detector.

56. The infusion system of any claim herein, wherein the controller is configured to control the infusion system to deliver a dose of the radioactive eluate to a patient during a patient infusion procedure.

57. The infusion system of any claim herein, wherein the controller is configured to control the infusion system to prevent the patient infusion procedure if the determined activity of strontium-82 exceeds an allowable limit.

58. The infusion system of any claim herein, wherein the controller, the pump, the radioisotope generator, the waste container, the eluate-receiving container, the infusion tubing circuit, the beta detector, and the gamma detector are each supported on the moveable frame and moveable therewith.

59. The infusion system of any claim herein, further comprising a hands-free braking system.

60. The infusion system of any claim herein, further comprising a touch screen supported on the moveable frame and moveable therewith, the touch screen being in electronic communication with the controller.

61. The infusion system of any claim herein, further comprising a multi-way divergence valve connected to the infusion tubing line, waste line, and eluate line, wherein the eluate line extends from the radioisotope generator to the multi-way divergence valve, the infusion tubing line extend from the multi-way divergence valve to the eluate-receiving container, and the waste line extend from the multi-way divergence valve to the waste container.

62. The infusion system of any claim herein, further comprising further a bypass valve that is in fluid communication with the pump and the eluate line via a bypass line, the bypass line being configured to allow eluant to bypass the radioisotope generator and flow directly into the eluate line.

63. An infusion system comprising:radioactive shielding enclosing at least a portion of the infusion tubing circuit, the beta detector, and the gamma detector;a gamma detector positioned to measure gamma emissions emitted from radioactive eluate generated by the radioisotope generator and received by the eluate-receiving container; andwherein the controller is configured to determine an activity of rubidium-82 in the radioactive eluate based on beta emissions measured by the beta detector and determine an activity of strontium-82 in the radioactive eluate based on gamma emissions measured by the gamma detector, and64. The infusion system of any claim herein, wherein the controller is configured to control the infusion system to prevent the patient infusion procedure if the determined activity of strontium-82 exceeds an allowable limit.

65. The infusion system of any claim herein, wherein the eluate-receiving container is positioned coaxially with and vertically above the gamma detector.

66. The infusion system of any claim herein, further comprising:a multi-way divergence valve connected to the infusion tubing line, waste line, and eluate line, wherein the eluate line extends from the radioisotope generator to the multi-way divergence valve, the infusion tubing line extend from the multi-way divergence valve to the eluate-receiving container, and the waste line extend from the multi-way divergence valve to the waste container, and