Radioisotope generator

Abstract

A radioisotope generator is disclosed, the radioisotope generator comprising: a housing; a radioactive source region located in the housing and configured to receive a radioactive source emitting a radioisotope; and a container movement mechanism located in the housing. The container movement mechanism is configured to cause movement of a first container between: (i) a source exposure position, wherein the first container is positioned in the housing adjacent to the radioactive source, and wherein an internal surface of the first container is configured to be exposed to the radioactive source to receive the radioisotope; and (ii) a collection position, wherein the first container is positioned in the housing for elution of the received radioisotope.

Description

Radioisotope generatorCross-reference to Related Applications

[0001] This application claims the benefit of Australian Provisional Application No. 2024903000, filed 19 September 2024, which is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.Technical Field

[0002] The present disclosure relates to radioisotope generators and associated components for collecting radioisotope.Background

[0003] Radiopharmaceuticals may be used for therapeutic or diagnostic applications, such as for cancer treatment. A radiopharmaceutical contains a radioisotope that is selected to achieve a desired clinical outcome. To minimise side effects, careful selection of the radioisotope is necessary.

[0004] Targeted alpha-particle therapy is a method for targeted treatment of tumour cells, involving a radioisotope that undergoes alpha decay to kill the cells. There are presently difficulties in manufacturing radioisotopes with consistent quality and properties at scale, which inhibits the wide-spread adoption of targeted alpha-particle therapy.

[0005] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims.Summary

[0006] Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0007] Some embodiments of the present disclosure relate to a radioisotope generator, comprising: a housing; a radioactive source region located in the housing and configured to receive a radioactive source emitting a radioisotope; and a container movement mechanism located in the housing and configured to cause movement of a first container between:(i) a source exposure position, wherein the first container is positioned in the housing adjacent to the radioactive source, and wherein an internal surface of the first container is configured to be exposed to the radioactive source to receive the radioisotope; and(ii) a collection position, wherein the first container is positioned in the housing for elution of the received radioisotope.

[0008] The radioisotope generator may further comprise a first fluid connection configured to transfer eluted radioisotope from the first container located in the collection position to a remote collection location.

[0009] The container movement mechanism may be movable to a loading position wherein the first container is configured to be releasably mounted to the container movement mechanism. The loading position may be at, adjacent to, or beneath the collection position.

[0010] The container movement mechanism may be configured to connect the first container to a cap when the first container is at the collection position, the cap configured to cover a chamber of the first container that receives eluant for elution of the received radioisotope. The cap may comprise a vent for venting the chamber when the chamber receives the eluant.

[0011] The container movement mechanism may be configured to move the first container between the source exposure position and the collection position by a movement comprising a linear movement and / or rotational movement. The linear movement may comprise a first lifting and lowering movement including: (i) lifting thefirst container from a first position beneath the source exposure position to the source exposure position; and (ii) lowering the first container from the source exposure position to the first position.

[0012] The linear movement may comprise a second lifting and lowering movement including: (i) lifting the first container from a second position beneath the collection position to the collection position and (ii) lowering the first container from the collection position to the second position. The container movement mechanism may be configured to rotate the first container between the first position and the second position.

[0013] The container movement mechanism may comprise: (i) a scissor lift; (ii) a first linear actuator; and / or (iii) a belt or chain; configured to lift and lower the first container.

[0014] The container movement mechanism may comprise a collector arm configured to releasably retain the first container and move the first container between the source exposure position and the collection position. The collector arm may be configured to rotate to move the first container from the first position to the second position. The collector arm may be configured to rotate about a central shaft of the container movement mechanism.

[0015] The collector arm may be configured to releasably retain a second container, the container movement mechanism configured to cause movement of the second container between: (i) the source exposure position, wherein the second container is positioned in the housing adjacent to the radioactive source, and wherein an internal surface of the second container is configured to be exposed to the radioactive source to receive the radioisotope; and (ii) a collection position, wherein the second container is positioned in the housing for collection of the received radioisotope.

[0016] The container movement mechanism may be configured to simultaneously move the first container and the second container. The container movement mechanism may be configured to simultaneously: (i) position the first container in the source exposure position and position the second container in the collection position; or (ii) position the second container in the source exposure position and position the first container in the collection position. The movement of the first container between the source exposure position and the collection position may further comprise a rotational movementconfigured to rotate the first and second containers at least partially between the source exposure position and the collection position.

[0017] The radioactive source may be configured to be accessed through an opening in a first side of the housing. A top surface of the housing may be configured to support a second one of the radioisotope generator, wherein the opening in the first side of the housing remains accessible when the second radioisotope generator is supported on the top surface. The housing may comprise a door providing access to the container movement mechanism through a second side of the housing. The radioisotope generator may comprise an access panel, the access panel movable or removable to enable access to an interior region of the generator through the opening in the first side of the housing.

[0018] The generator may comprise a source support for supporting the radioactive source within the housing, the source support being slidably mounted to the housing. The source support may be mounted on a sliding rail mechanism having: (i) a contracted configuration wherein the source support is within the housing; and (ii) an extended configuration wherein the source support is located at least partially outside the opening in the first side of the housing.

[0019] The source support may comprise a locator pin for alignment of the support within the housing when the sliding rail mechanism is in the contracted configuration. The source support may comprise a window and an adjustable closure such as a shutter configured to uncover and cover the window to control the passage of the radioisotope through the window. The generator may further comprise: (i) a source shield assembly containing the radioactive source, the source shield assembly defining an aperture through which the radioactive source emits the radioisotope; and (ii) an adjustable closure such as a shutter movable between a closed state, wherein the shutter covers the aperture to form a gas-tight compartment containing the radioactive source; and an open state, wherein the shutter uncovers the aperture to allow the radioactive source to be in gas communication with an interior volume of the first container. The radioisotope generator may further comprise a controller and a position sensor, the position sensor connected to the container movement mechanism and configured to detect when the container movement mechanism is performing the linear movement of the first container.

[0020] The controller may be configured to operate a shutter mechanism to move the shutter to: (i) uncover the aperture in response to a signal from the position sensor indicative of the container movement mechanism lifting the first container; and (ii) cover the aperture in response to a signal from the position sensor indicative of the container movement mechanism lowering the first container. The shutter mechanism may be a shutter lever arm configured to releasably engage with a shutter lever actuator to prevent movement of the sliding rail mechanism from the contracted configuration when the aperture is uncovered.

[0021] The radioisotope generator may further comprise a pneumatic system configured to operate the container movement mechanism. The radioisotope generator may further comprise a vacuum connection configured to connect the first container to a vacuum pump when located at the source exposure location. The radioisotope generator may further comprise a second fluid connection configured to transfer eluant to the first container when located at the collection position.

[0022] Some embodiments of the present disclosure relate to a radioisotope generator system, comprising: a housing containing therein: a radioactive source having an emanation surface from which radioisotope gas can emanate upon decay of the radioactive source; a source shield assembly for containing the radioactive source and reducing alpha and gamma radiation levels outside of the housing that result from decay of the radioactive source, which source shield assembly has a closed state in which the radioactive source is entirely contained within an gas-tight compartment therein; and a collection container having an interior volume for collecting radioisotope gas emanating from the radioactive source and an interior wall for collecting radioisotope precipitating as a solid from decay of the radioisotope gas in the interior volume; wherein the system further includes:an adjustable closure for reversibly providing the radioactive source between (i) being in gas communication with the interior volume of the collection container, and (ii) being disposed in the closed state of the source shield assembly; at least one fluid path for: introducing a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the radioisotope precipitated on the interior wall and form a radioisotope solution; and to remove the radioisotope solution from the collection container, wherein the at least one fluid path is configured to be operable while the collection container is disposed within the housing.

[0023] The at least one fluid path may be configured to sequentially operate as:(i) an elution inlet, configured to introduce a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the radioisotope precipitated on the interior wall and form the radioisotope solution; and(ii) an elution outlet, configured to drain the radioisotope solution from the interior volume.

[0024] The at least one fluid path may be configured to direct the radioisotope solution to a common pooled collection container.

[0025] The radioactive source may be a228Th-containing source. The radioisotope gas may be220Rn gas emanating upon decay of the228Th-containing source to224Ra and the decay of the224Ra to220Rn. The radioisotope that is precipitating as a solid from decay of the220Rn gas may be212Pb. The radioisotope solution may be a212Pb solution.

[0026] Some embodiments of the present disclosure relate to an interconnected radioisotope generator system, comprising a plurality of the radioisotope generator or comprising a plurality of the radioisotope generator system as described herein, each one of the plurality of the radioisotope generator or the plurality of the radioisotope generator systems being configured to direct radioisotope solution to a common pooled collection container.

[0027] Some embodiments of the present disclosure relate to a radioisotope generator system, comprising: a housing containing therein:a228Th-containing source having an emanation surface from which220Rn gas can emanate upon decay of the228Th to224Ra and the224Ra to220Rn; a source shield assembly for containing the228Th-containing source and reducing alpha and gamma radiation levels outside of the housing that result from decay of the228Th, which source shield assembly has a closed state in which the228Th-containing source is entirely contained within an gas-tight compartment therein; and a collection container having an interior volume for collecting220Rn gas emanating from the228Th-containing source and an interior wall for collecting 212Pb precipitating as a solid from decay of the220Rn gas in the interior volume; wherein the system further includes: means for reversibly providing the228Th-containing source between (i) being in gas communication with the interior volume of the collection container, and (ii) being disposed in the closed state of the source shield assembly; means for introducing a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the212Pb precipitated on the interior wall and form a212Pb solution; and means to remove the212Pb solution from the collection container, wherein the means is configured to be operable while the collection container is disposed within the housing.

[0028] The means for introducing a fluid may be configured to sequentially operate as:(i) an elution inlet, configured to introduce a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the212Pb precipitated on the interior wall and form the212Pb solution; and(ii) an elution outlet, configured to drain the212Pb solution from the interior volume.

[0029] The means for introducing a fluid may be configured to direct the212Pb solution to a common pooled collection container.

[0030] Some embodiments of the present disclosure relate to a disposable apparatus for use with a radioisotope generator, the apparatus comprising:a first collection container comprising a first collection recess, an inner surface of the first collection recess configured to be exposed to a radioisotope emitted from a radioactive source in the radioisotope generator; a cap configured to engage with the first collection container to form a first collection chamber between the cap and the inner surface; wherein the first collection chamber is configured be in fluid connection with an elution source to transfer the radioisotope to a fluidics handling system, wherein the first collection container is configured such that an elution fluid from the elution source enters and exits the first collection chamber through at least one elution port of the first collection container.

[0031] The at least one elution port may be at a base of the first collection container. The base of the first collection container may extend beyond a perimeter of an outer wall of the first collection container to define a base flange. The at least one elution port may be a single elution port configured to provide entry of the elution fluid into the first collection container and subsequently, drainage of the elution fluid from the first collection container.

[0032] The cap may comprise a plug portion configured to extend into the first collection chamber. The plug portion may have an outer surface having a shape substantially corresponding to a shape of the inner surface. The shapes of the outer and inner surfaces may extend parallel to each other when the cap seals the first collection chamber. The outer surface and the inner surface may each have substantially conical or frustoconical shapes. The at least one elution port may be located at an apex of the conical or frustoconical shape of the inner surface.

[0033] The cap may comprise a cap flange defining a groove configured to engage with a lip of the first collection container to seal the first collection container. The cap may comprise a vent for venting the first collection chamber. The vent may comprise a filter. The disposable apparatus may further comprise a cap tube, the cap tube connecting to the vent to assist venting of the first collection chamber.

[0034] The disposable apparatus may further comprise an elution tube configured to be connected to the at least one elution port. The disposable apparatus may further comprisea tube support connected to the elution tube and configured to support the elution tube in a housing of a radioisotope generator.

[0035] The disposable apparatus may further comprise a second collection container. The second collection container may be a blank container comprising a second collection recess, an inner surface of the second collection recess configured to be exposed to the radioisotope; wherein the second collection container may be configured to engage with the cap to form a second collection chamber between the cap and the inner surface, the second collection chamber being fluidly sealed to contain the radioisotope deposited on the inner surface. The second collection container may not have an elution port, unlike the first collection container.

[0036] Some embodiments relate to a radioisotope generator, comprising: a housing configured to locate within an internal volume of a radiation containment chamber; a radioactive source region located in the housing and configured to receive a228Th radioactive source emitting a gaseous220Rn radioisotope; one or more sensors configured to provide one or more measurements relating to the amount of gaseous220Rn radioisotope within the housing of the radioisotope generator and / or within the internal volume of the radiation containment chamber in which the radioisotope generator is configured to be located; a first controller configured to receive the one or more measurements from the one or more sensors and send an instruction signal to a door interlock controller of the radiation containment chamber based on the one or more measurements; wherein the first controller, based on an amount of gaseous220Rn radioisotope measured by the one or more sensors being at or above a predetermined threshold level, provides the instruction signal to the door interlock controller to lock or maintain locking of one or more doors of the radiation containment chamber.

[0037] The first controller may be configured to determine if one or more other hazard criterion is met, such as the presence of at least one of x-ray, alpha, beta or gamma radiation above a predefined threshold level within the housing of the radioisotope generator and / or within the internal volume of the radiation containment chamber, andcontrol locking of the one or more doors of the radiation containment chamber based on the determination.

[0038] The radioisotope generator may comprise one or more additional sensors selected from:(i) a position sensor configured to detect a position of a container movement mechanism inside the housing;(ii) an accelerometer configured to detect a rate of movement of a container movement mechanism inside the housing;(iii) a delay timer configured to monitor a time period associated with operation of a door or lid of the housing; and / or(iv) a power state sensor configured to measure a power state of the generator; wherein the first controller is configured to control locking of the one or more doors of the radiation containment chamber based on one or more signals received from the one or more additional sensors.

[0039] The radioisotope generator may be a radioisotope generator as described in any other embodiments herein.

[0040] In certain embodiments, the generator includes the228Th radioactive source at the radioactive source region.Brief Description of Drawings

[0041] Fig. 1 is a perspective view of a radioisotope generator, according to some embodiments;

[0042] Fig. 2 is a perspective view of the radioisotope generator of Fig. 1, showing a door of the generator in an open configuration, according to some embodiments;

[0043] Fig. 3 is a perspective view of the radioisotope generator of Figs. 1 and 2, with part of the housing of the generator removed, according to some embodiments;

[0044] Fig. 4A is a close up, section view, of a radioactive source assembly including a radioisotope source of the radioisotope generator, showing a first container before exposure to the radioisotope source, according to some embodiments;

[0045] Fig. 4B is a close up, section view, of a radioisotope source of the radioisotope generator taken along the line 4B-4B marked in Fig. 3, showing the first container of Fig. 4A exposed to the radioisotope source, according to some embodiments;

[0046] Fig. 5A is a perspective view showing a source assembly support of the radioisotope generator in a contracted configuration, according to some embodiments;

[0047] Fig. 5B shows the source assembly support of Fig. 5 A in a maximally extended configuration, according to some embodiments;

[0048] Fig. 5C shows the source assembly support from a reverse angle to Figs. 5A and 5B, according to some embodiments;

[0049] Fig. 5D (i) and (ii) are simplified diagrams showing the movement of a shutter relative to a platform of the source assembly support. Fig. 5D (i) shows the shutter in an open configuration, while Fig. 5D (ii) shows the shutter in a closed configuration;

[0050] Fig. 6A is a perspective view of a top portion of the first container, according to some embodiments;

[0051] Fig. 6B is a perspective view of a bottom portion of the first container, according to some embodiments;

[0052] Fig. 6C is a section view, taken along the line 6C-6C marked in Fig. 6A, showing an internal configuration of the first container, according to some embodiments;

[0053] Fig. 7A is a perspective view of a top portion of a second container, according to some embodiments;

[0054] Fig. 7B is a perspective view of a bottom portion of the second container, according to some embodiments;

[0055] Fig. 8A is a perspective view, from a first angle, of a cap configured to cover the first container, according to some embodiments;

[0056] Fig. 8B is a perspective view, from a second angle, of the cap, according to some embodiments;

[0057] Fig. 9A shows the cap of Figs 8 A and 8B connected to the first container, according to some embodiments;

[0058] Fig. 9B is a section view, taken along the line 9B-9B marked in Fig. 9A, showing the cap connected to the first container, according to some embodiments;

[0059] Fig. 10A is an elevation view of a container movement mechanism of the radioisotope generator of Fig. 1, according to some embodiments;

[0060] Fig. 10B is a partial section view taken along the line 10B-10B marked in Fig. 10 A, according to some embodiments;

[0061] Fig. 10C shows a simplified schematic of the container movement mechanism in various positions, wherein Fig. 10C (i) is a schematic of a loading position, Fig. 10C (ii) is a schematic of a collection position, Fig. 10C (iii) is a schematic of a second position of the first container, Fig. 10C (iv) is a schematic of a first position of the first container, and Fig. 10C (v) is a schematic of a source exposure position of the first container;

[0062] Fig. 11 is a perspective view of an elution system comprising at least one radioisotope generator and a fluidics handling system, such as a radiosynthesizer, according to some embodiments;

[0063] Fig. 12 is a perspective view of an installation comprising a radiation containment chamber, such as a “hotcell”, for synthesis of a radioisotope, containing the elution system of Fig. 11;

[0064] Fig. 13 A is a block diagram showing operation of a generator, according to some embodiments;

[0065] Fig. 13B is a block diagram showing operation of safety features of the radiation containment chamber of Fig. 12 containing a plurality of the generators of Fig. 1; and

[0066] Fig. 14 is a process flow diagram showing replacement of disposable apparatus of the generator, according to some embodiments.Detailed Description

[0067] The present disclosure relates to radioisotope generators and associated components for collecting radioisotope.

[0068] Fig. 1 is a perspective view showing a radioisotope generator 100, according to some embodiments of the present disclosure. As will be explained in more detail in the subsequent discussions, the radioisotope generator 100 may comprise a housing 110, a radioactive source region located in the housing and configured to receive a radioactive source emitting a radioisotope, and a container movement mechanism located in the housing and configured to move a container for exposure to the radioactive source in order to receive the radioisotope in the container. The mechanism may also move the container in the housing to a position for elution of the received radioisotope.

[0069] In some embodiments, the housing 110 may comprise a door 120 to enable access to an interior region of the generator 100. The door 120 may be hingedly connected to the housing 110 to be movable between a closed configuration (such as shown in Fig. 1) and an open configuration (such as shown in Fig. 2). The door 120 may be provided at a front of the housing 100, for example. In some embodiments, the generator 100 comprises a door sensor which detects if the door 120 is in the open or closed configuration, wherein one or more functions of the generator (and / or of a radiation containment chamber such as a hotcell in which the generator may be located) are limited and / or triggered if the door 120 is in the open or closed configuration. For example, the container movement mechanism may be prevented from moving the container when the door 120 is in the open configuration. As a safety feature, exposure of the container to the radioactive source may be prevented when the door 120 of the generator is in the open configuration. As another example, an access panel such as a door of the radiation containment chamber such as a hotcell may be prevented from opening when the door 120 of the generator is in the open configuration.

[0070] In some embodiments, the housing 110 comprises one or more panels 130. At least one of the panels 130 may be an access panel 132 that is configured to selectively cover one or more openings through which an interior of the generator 100 can be accessed, which one or more openings may be at a different location from an opening 125 (shown in dashed lines) covered by the door 120, such as a location closer to the radioactive source region. The access panel 132 may be movable or removable to enable access to an interior region of the generator 100, such as to allow access to the radioactive source region. The access panel 132 may be shielded to reduce or prevent the passage ofradiation from the interior of the generator 100 to the exterior when the at least one panel 130 closes the one or more openings. The access panel 132 may be provided at a first side of the housing.

[0071] The access panel 132 may be configured to engage with a first panel 134 to cover an opening 135 (shown in dashed lines) in the first panel 134. The access panel 132 may be removable from the housing 100 independently of the first panel 134. In some embodiments, removal of the first panel 134 also removes the access panel 132, but removal of access panel 132 does not necessarily remove the first panel 134. The access panel 132 may be comprise a lip or tab 138 at a first end of the access panel 132, wherein the tab 138 is configured to engage with a corresponding feature of the first panel 134 to retain the first end of the panel, while an opposite second end of the access panel 132 may be secured to the first panel 134 by one or more removable fasteners, such as screws or bolts 140. The access panel 132 may be configured to selectively obstruct or allow access to a radioactive source in the generator 100. The access panel 132 may be configured to be stay in position when tab 138 is engaged. As an alternative to employing a removable access panel 132, an access panel may be provide that is hinged or slidably mounted to the housing, providing a form of access door or hatch.

[0072] The housing 110 may comprise a base 150. The base 150 may be configured to support one or more of the components inside the generator 100. The base 150 may be configured to enable a plurality of the generators 100 to be stacked on top of each other. For example, a top surface of the housing 110 of one generator 100 may be configured to receive and support the base 150 of a second generator 100 such as in an arrangement as shown in Figs. 11 and 12, where three generators 100 are stacked on top of each other in this manner. The base 150 may comprise feet 152 or other discrete regions that are configured to engage with the top surface of the housing 110 of the generator 100 below, such as a top surface provided by the first panel 134. The opening 135 in the housing 110, which may be selectively covered by the access panel 132 as described above, may remain accessible when the second radioisotope generator 100 is supported on the top surface, e.g. as a result of it being located at a first side of the housing 110, albeit in some alternative embodiments the access panel 132 may alternatively be located at different side, front or rear of the housing 130 and remain accessible. Additionally oralternatively, the door 120 of the generator 100 may remain accessible when the second radioisotope generator 100 is supported on the top surface, e.g. as a result of it being located at a front of the housing 110, albeit in some alternative embodiments the door 120 may alternatively be located at a side or rear of the housing 130 and remain accessible.

[0073] In some embodiments, the housing 110 may comprise a second panel 136. The second panel 136 may be configured to engage with the first panel 134 and / or the access panel 132. The first panel 134 may be configured to generally cover a first lateral side and / or top region of the generator 100, while the second panel 136 may be configured to generally cover a second lateral side and / or top region of the generator 300. The panels 130 may be adjoining and may comprise corresponding lips that are configured to overlap when the panels 130 are adjoined to avoid or at least reduce any gap being formed between the panels. The avoidance or reduction of said gap may be for aesthetic purposes, dust ingress, and / or for shielding purposes.

[0074] Fig. 2 shows the door 120 of the generator 100 in an open configuration. The door 120 may be supported by hinges 200 which enable movement between open and closed configurations as marked by arrow 202. The radioisotope generator 100 may comprise a container movement mechanism 1000 located in the housing 110, wherein the container movement mechanism 1000 is configured to cause movement of a first container 600. For example, as indicated by arrows 210, 212, the container movement mechanism 1000 may be configured to cause movement of a first container 600 between: (i) a source exposure position (such as illustrated in Fig. 4B), wherein the first container 600 is positioned in the housing 110 adjacent to a radioactive source 401 to be exposed to and receive radioisotope emitted from the radioactive source; and (ii) a collection position, wherein the first container 600 is positioned in the housing 110 for elution of the received radioisotope in order to collect the radioisotope. The radioactive source 401 may be a228Th-containing source from which220Rn gas emanates upon decay of the228Th. The radioisotope eluted and collected may be a solution containing212Pb that has precipitated from decay of the220Rn gas. An example of the collection position of the first container 600 is shown in Fig. 11.

[0075] Continuing to refer to Fig. 2, the container movement mechanism 1000 may be configured to raise and lower the first container 600. The container movementmechanism 1000 may raise (such as indicated by arrow 220) the first container 600 into the collection position, wherein the first container 600 may be connected to a cap 800 and an elution process may be carried out as described in more detail subsequently herein. After completion of the elution process, the container movement mechanism 1000 may lower (such as indicated by arrow 222) the first container 600, causing disconnection of the first container 600 from cap 800, wherein the first container 600 may be removed and / or replaced, for example as described with reference to Fig. 14.

[0076] The radioisotope generator 100 may comprise a fluid connection configured to transfer eluant to the first container 600, e.g., when the first container 600 is located at the collection position. The radioisotope generator 100 may comprise a fluid connection configured to transfer eluted radioisotope from the first container 600 to a remote collection location, e.g., when the first container 600 is located at the collection position. In some embodiments, the fluid connection for transferring eluant into and out of the first container 600 may be the same. In some embodiments, the fluid connections for transferring eluant into and out of the first container 600 may be separate and / or different. In the embodiment shown in Fig. 2, the radioisotope generator 100 comprises a single fluid connection 230 to transfer eluant into and out of the first container 600. The fluid connection 230 may comprise a tube 910 (Figs. 9A and 9B), which may be a flexible tube 910. The fluid connection 230 may be supported in the housing 110 by a tube support 240. The tube support 240 may be a bracket configured to removably connect to the housing 110 of the generator 100 to hold a part of the tube 910 in position relative to the housing 110.

[0077] The tube support 240 may hold the tube 910 at a first position relative to the housing that ensures a portion of the tube 910 between the first container 600 and the tube support 240 does not obstruct movement of the first container 600 by the container movement mechanism 1000 and / or is less likely to suffer damage or crimping during the movement. In this regard, the tube 910 may be configured to have a relatively slack configuration between the tube support 240 and the first container 600. Additionally or alternatively in this regard, the tube support 240 may hold the tube 910 at a first position relative to the housing 110 that is aligned with a centre of rotation of the container movement mechanism 1000, e.g. so that a distance between the first container 600 andthe first position at which the tube 910 is held by the tube support 240 remains substantially constant during rotation of the container movement mechanism 1000. The housing 110 may include a curved or part-circular channel in which the portion of the tube between the first container 600 and the tube support 240 is at least partially accommodated, including during rotation of the container movement mechanism 1000.

[0078] The tube support 240 may also hold the tube 910 at a second position relative to the housing where the tube 910 may exit the housing. The tube support 240 may have a bent or angled configuration between the first and second positions. The tube support 240 may include a bent or angled channel to receive the tube 910. The tube support 240 may fix or otherwise maintains a bend or angle in the tube 910, e.g. as the tube 910 exits the housing 110. The bend or angle may be at least 45 degrees, at least 60 degrees, at least 70 degrees, at least 80 degrees, or at least 90 degrees. The bend or angle that the tube support 240 maintains in the tube 910 may allow the tube 910 to navigate around a panel or opening in the housing 110, e.g., where the door of 120 of the housing is located as shown in Fig 2. The tube support 240 may ensure that a flow of eluant into and from the first container 600 can be maintained by the tube support 240 reducing the likelihood of the tube 910 being inadvertently damaged or crimped as it exits the housing 110.

[0079] Fig. 2 shows the first container 600 in a position close to the opening 125 accessed by door 120. The first container 600 may be moved away from the opening 125 by the container movement mechanism 1000.

[0080] A second container 700 (Fig. 7A, 7B) may be provided for use with the generator 100. The second container 700 may be a dummy or blank container, which is configured to be positioned by the container movement mechanism 1000 in the source exposure position when the first container 600 is not positioned in the source exposure position. The second container 700 may be disposable, and generally used to prevent prolonged exposure of non-disposable parts of the generator to the source when the first container 600 is not receiving radioisotope, reducing the risk of damage or excessive build-up of radioactivity.

[0081] Movement of the first container 600 away from the opening 125 may result in a corresponding movement of the second container 700 towards the opening 125. Fig, 3 shows the second container 700 in a position close to the door 120, at opening 125, whilethe first container 600 is now hidden from view within the generator 100. The second container 700 may be configured to engage with the cap 800, such as shown in Fig. 3. While the second container 700 is engaged with the cap 800, the first container 600 may be exposed to the radioactive source 401, such as shown in Fig. 4B. The second container 700 may not be configured for elution of radioisotope contained therein, so the fluid connection 230 may remain disposed away from the second container 700 such as shown in Fig. 3.

[0082] Fig. 3 shows the generator 100 with various panels 130 and door 120 removed in order to allow illustration of internal components of the generator 100. The generator 100 may comprise a floor 310 and a frame or chassis 320 for supporting components inside the generator 100. The chassis 320 may also provide mounting features for the one or more panels 130 and / or the door 120 to connect them to the chassis 320. The chassis 320 may comprise a door frame 321 that defines the opening 125 and a location for mounting the hinges 200.

[0083] The radioisotope generator 100 may comprise a radioactive source assembly 400 (Fig. 3) located in the housing 110, wherein the radioactive source assembly 400 is configured to receive a radioactive source 401 (Figs. 4A and 4B) emitting a radioisotope and wherein the radioactive source assembly 400 includes a source shield assembly 410 that shields the radioactive source 401 when received by the radioactive source assembly 400. The source shield assembly 410 may contain the radioactive source 401 to thereby reduce x-ray, alpha, beta and gamma radiation levels as measured outside the source shield assembly 410. The generator 100 may further comprise a source assembly support 500 configured to support the radioactive source 401 and more particularly, in this embodiment, support the radioactive source assembly 400 including the radioactive source 401. The source assembly support 500 may comprise a platform 560 on which the radioactive source assembly 400 is supported and may be movably connected to the chassis 320. The movable configuration of the source assembly support 500 may facilitate user access to the radioactive source 401, e.g. following removal of the access panel 132 covering the opening 135. In Fig. 1, the access panel 132 is shown covering the opening 135, the approximate size and location of which opening is shown as a dashed line. In Fig. 3, the panels 130 are removed, so the approximate size and locationof the opening 135 as would be defined by the first panel 134 is shown as a dashed line. In some embodiments, the source assembly support 500 is configured to slide relative to the chassis 320. The source assembly support 500, along with the radioactive source assembly 400 supported thereon, may be configured to slide through the opening 135 in the first panel 134 to facilitate access to the radioactive source 401. The chassis 320 may comprise mounts for supporting various ports for supplying fluid to the generator 100. For example, the chassis 320 may support an air input port 330 for providing air, such as to provide actuation of pneumatic system 1340. The chassis may define an external vent interface 340. The external vent interface 340 may be connected to vent / filter 840 by a tube, such as tube 342 shown in dashed lines on Fig. 3.

[0084] Fig. 4A is a section view showing the first container 600 adjacent to the radioactive source assembly 400, but not exposed to the radioactive source 401. Fig. 4B is a section view at the location marked by line 4B— 4B of Fig. 3 and shows the first container 600 exposed to the radioactive source 401. Figs. 4A and 4B show the configuration of the radioactive source assembly 400, including the source shield assembly 410 and the radioactive source 401, according to the present embodiment in more detail.

[0085] In Fig. 4A, the first container 600 is shown in a position lowered from the source exposure position. The radioactive source 401 may be generally puck-shaped or mushroom-shaped. In some embodiments, the radioactive source 401 comprises an upper portion 402 and an adjacent lower portion 404, the upper portion 402 being wider than the lower portion 404 such that a shoulder 406 is defined between the upper portion 402 and the lower portion 404. The lower portion 404 may define an emanation surface. The emanation surface may be a bottom surface of the lower portion 404. The emanation surface may be one of a plurality of emanation surfaces.

[0086] The source shield assembly 410 may comprise a body 420 and a lid 430. The body 420 may define an upper recess 422, a lower recess 428 and an aperture 424 between the upper recess 422 and the lower recess 428. The emanation surface may extend into the lower recess 428 to emit radioisotope into the lower recess 428, and subsequently, into a container (such as first container 600) that is received in the lower recess 428. The radioactive source 401 may be a228Th-containing source from which220Rn gas emanates via the emanation surface upon decay of the228Th. The subsequent decay of the220Rn gas precipitates212Pb into the container. The upper portion 402 of the radioactive source 401 may be received in the upper recess 422 and the lower portion 404 of the radioactive source 401 may extend through the aperture 422 to the lower recess 428. The upper recess may be at least partially frustoconical in shape to assist in guiding the positioning of the radioactive source into the upper recess 422 and across the aperture 424 of the body 420. The body 420 may comprise a ledge 426 having an upper surface on which the shoulder 406 of the radioactive source 401 may rest or abut to retain the radioactive source 401 in the body 420. The ledge 426 may encircle the aperture 424. The lower portion 404 of the radioactive source 401 may extend through the aperture 424 when the shoulder 406 is retained on the ledge 426. The lower recess 428 may be configured to receive a container for exposure to a radioisotope emitted from the radioactive source 401, such as the first container 600. The lower recess 428 may be configured to guide the first container 600 into a source exposure position adjacent to the radioactive source 401. In some embodiments, the lower portion 404 of the radioactive source 401 may extend into the first container 600 when the first container 600 is in the source exposure position to receive the radioisotope (shown in Fig. 4B).

[0087] Fig. 4B is a section view similar to Fig. 4A, but showing the first container 600 in the source exposure position. To allow the first container 600 to reach the source exposure position, an adjustable closure such as a shutter 550 (discussed in more detail below) may be moved, and the first container 600 may be raised, e.g. by the container movement mechanism 1000, to be received in the lower recess 428 of the body 420 until a top rim surrounding an opening of the container 600 abuts a bottom surface of the ledge 426. This positioning of the container 600 may ensure that the lower portion 404 of the radioactive source 401 locates over the opening of the container, and in some embodiments is at least partially received in the first container 600. Radioisotope emitted from the radioactive source 401 may therefore be received in and contained within the first container 600. When the shutter 550 is moved to an open configuration for passage of the radioisotope, the radioactive source 401 can therefore be in gas communication with the first container 600. In some embodiments, the generator 100 comprises a vacuum source (not shown) for creating a vacuum or lower pressure in the first container600 or the second container 700 when the container is exposed to the radioactive source 401.

[0088] The lid 430 of the source shield assembly 410 may comprise a bung portion 432, a flange portion 434, and a hub portion 436. The bung portion 432 may be configured to extend into the upper recess 422 of the body 420. The bung portion 432 may extend into the upper recess 422 and abut the upper portion 402 of the radioactive source 401 or alternatively, as shown in Figs 4A and 4B, it may abut a spacer 408 located between the lid 430 and the upper portion 402 of the radioactive source 401. The spacer 408 may be formed of resilient material such a rubber, acting as a damper and ensuring a tighter fit between the lid 430 and the source 401. The flange portion 434 of the lid 430 may simultaneously abut an upper surface of the body 420 of the source shield assembly 410. The lid 430 may be secured to the body 420, such as via an O-ring seal or other resilient element 438 surrounding the upper surface of the body 420.

[0089] The lid 430 may be secured to the upper surface of the body 420 using a bayonet-type or slide engagement mechanism wherein, upon rotation of the lid 430, one or more pins or screws 421 located on the upper surface of the body 420 move within corresponding slots 431 provided in the lid 430, as seen, for example, in Figs. 3 and 5A. After rotational movement of the pins or screws 421 within the slots 431, a releasable spring pin lock in the lid 430 may be used to limit any return movement until the spring pin lock is manually released.

[0090] Continuing to refer to Figs. 4A and 4B, the hub portion 436 of the lid 430 may extend from the flange portion 434. The source shield assembly 410 may further comprise a handle 440 connected to the lid 430, such as to the hub portion 436. The handle 440 may be configured to allow a user to easily take hold of and handle the source shield assembly 410 (and the radioactive source 401 within). The handle 440 may also be configured to allow a user to easily rotate the lid 430 relative to the body 436 to achieve the bayonet-type or slide engagement between the lid 430 and body 420 as described above with reference to screws 421 received in slots 431. In an alternative embodiment, a different engagement mechanism such as a screw engagement or clip engagement mechanism may be provided between the lid 430 and the body 420.

[0091] Figs. 5 A and 5B show the chassis 320, the radioactive source assembly 400 including source shield assembly 410 (containing the radioactive source 401), and the source assembly support 500. Fig. 5C shows the source assembly support 500 in isolation and from a reverse angle to its depiction in Figs. 5A and 5B.

[0092] Figs. 5A, 5B and 5C show an embodiment of the source assembly support 500 that is configured to slide relative to the chassis 320. The source assembly support 500 may comprise a drawer type arrangement wherein a sliding rail mechanism such as a set of one or more rails 510 enables sliding of the radioactive source assembly, including the radioactive source 401, relative to the chassis 320. The source assembly support 500 may move between a contracted (or collapsed) configuration and an extended (or expanded) configuration. In the contracted configuration the source assembly support 500 is entirely or at least substantially within the housing 110, while in the extended configuration the source assembly support 500 is located at least partially outside the housing 110, e.g. by extending out of the opening 135 in the first side of the housing 110.

[0093] Fig. 5A shows the source assembly support 500 in the contracted configuration. Fig. 5B shows the source assembly support 500 in the extended configuration. The source assembly support 500 may take a plurality of intermediate configurations (not shown) between the contracted configuration and the extended configuration. Reference herein to the expanded configuration will be understood to include any one of the intermediate expanded configurations and the maximally extended configuration, unless explicitly noted otherwise.

[0094] In the extended configuration, the source assembly support 500 extends through the opening 135 (Figs. 1 and 3) in the first panel 134 when access panel 132 has been removed. The source assembly support 500 may thereby allow easy access to the radioactive source 401 of the generator 100, even when multiple generators 100 may be stacked above or below each other (such as shown in Figs. 11 and 12).

[0095] When moving to the extended configuration, the source assembly support 500 is moved away from a first side wall 322 of the housing 110 by sliding along the set of rails 510. The set of rails 510 may be attached to a rear wall 324 of the housing 110.

[0096] In some circumstances, the weight of the radioactive source assembly 400 that is supported on the source assembly support 500 may cause the source assembly support 500 to tilt or sag relative to housing 110. Accordingly, in the contracted configuration, the generator 100 may be further configured such that the source assembly support 500 is supported in the housing at a location separate from the rails 510 / rear wall 324. For example, the source assembly support 500 may be additionally supported in the contracted configuration at the first side wall 372 of the housing, e.g. through use of a support arrangement 520 at the first side wall 372. Contraction of the set of rails 510 may bring the source assembly support 500 into temporary engagement with the support arrangement 520 at the first side wall 322 to hold the source assembly support 500 in a consistent, secure position. For example, it may be desirable to hold the source assembly support 500 to consistently be substantially parallel (level) with the floor 310. Holding the source assembly support 500 in a consistent position may make it easier to efficiently expose the first container 600 to the radioisotope as the relative components are less likely to become misaligned.

[0097] In some embodiments, the support arrangement 520 configured to support and / or align the source support 500 with the housing 110 when in the contracted configuration may comprise a socket 522 and a locator pin 524. The socket 522 may be provided in or on the first side wall 322, and the locator pin 524 may extend from the source assembly support 500. The locator pin 524 may align the source assembly support 500 within the housing 110 when the source assembly support (by virtue of the sliding rail mechanism 510) is moved into the contracted configuration. In the extended configuration, the locator pin 524 is separated from the socket 522, and in the contracted configuration, the locator pin 524 engages with and is received in the socket 522. The locator pin 524 may comprise a tapered or conical tip 526 (Fig. 5B) to guide the pin 524 into the socket 522 if the source assembly support 500 becomes slightly tilted or misaligned with the socket 522 while in the extended configuration.

[0098] Turning now to Fig. 5C, in some embodiments, the source assembly support 500 further comprises a shutter mechanism. Operation of the shutter mechanism may cause an adjustable closure such as a shutter 550 to open and close in order to uncover and cover a window 562 of the source assembly support 500 through which the radioactivesource 401 can be accessed for exposure to the radioisotope. When the shutter 550 is moved to an open configuration for passage of the radioisotope through the window 562, the radioisotope source 401 can be in gas communication with the first container 600. In some embodiments, a gas permeable filter is disposed between the radioisotope source 401 and the container received through the window 562. The gas permeable filter may be configured to capture particulates. The shutter mechanism may be configured such that the shutter 550 can only be opened if the source assembly support 500 is in the contracted configuration. For example, the shutter mechanism may include a mechanical linkage to open and close the shutter 550, which mechanical linkage is formed only when the source assembly support 500 is in the contracted. The mechanical linkage may be provided, for example, by a shutter lever arm 530 and a shutter lever wheel 540, which are discussed in more detail below. When the shutter 550 is in the closed configuration, the shutter 550 may form a gas-tight seal with the source shield assembly 410 so that the lower recess 428 of the source shield assembly 410 is a gas-tight compartment.

[0099] The shutter 550 may be positioned over a shutter window 562 in a tray or platform 560 of the source assembly support 500. The platform 560 may be configured to directly support the source shield assembly 410 when the source shield assembly 410 is received on the source assembly support 500, such as shown in Figs. 4A and 4B. Continuing to refer to Figs. 4A and 4B, the shutter window 562 defined in the platform 560 (marked with the bold dashed line, also in Fig. 5C) may provide, when not covered by the shutter 550, an access opening through which the first container 600 can extend to enter the lower recess 428 of the source shield assembly 410 and be in the source exposure position adjacent to the radioactive source 401.

[0100] Turning again to Fig. 5C, and as indicated above, the shutter mechanism may comprise a shutter lever arm 530 and a shutter lever wheel 540. The shutter lever arm 530 may be configured to releasably engage with the shutter lever wheel 540 when the source assembly support 500 is in the contracted configuration. The shutter 550 may be disposed at a first end of the shutter lever arm 530. The shutter lever arm 530 may comprise a first finger 532 and a second finger 534 extending from a second end of the shutter lever arm 530 opposite to the shutter 550. The fingers 532, 534 may define a finger space 536 therebetween. The finger space 536 may be open ended to allow the shutter lever wheel540 to be slid or rolled in and out of the finger space 536. When the source assembly support 500 is in the extended configuration, the first finger 532 and the second finger 534 are disengaged from the shutter lever wheel 540. When the source assembly support 500 is moved into the contracted configuration, such as shown in Fig. 5C, the first finger 532 and the second finger 534 engage with the shutter lever wheel 540 and guide the shutter lever wheel 540 to be received in the finger space 536.

[0101] The shutter lever arm 530 may be connected to the platform 560 at a pivot 538. The pivot 538 may be disposed between the shutter 550 and the fingers 532, 534 to allow rotation of the shutter 550 and the fingers 532, 534 about the pivot 538.

[0102] The generator 100 may further comprise an actuator 570 that is connected to the shutter lever wheel 540 and configured to move the shutter lever wheel 540. The shutter lever wheel 540 may be connected to a piston 572 of the actuator 570. Operation of the actuator 570 extends and retracts the piston 572 relative to an actuator body 574 of the actuator 570, thereby also moving the shutter lever wheel 540 towards and away from the actuator body 574.

[0103] When the source assembly support 500 is in the contracted configuration, such as shown in Fig. 5C, the shutter lever wheel 540 is engaged with the shutter lever arm 530. Operation of the actuator 570 moves the shutter lever wheel 540, causing the shutter lever arm 530 to rotate about the pivot 538 and move the shutter 550. For example, extension of the piston 572 causes the fingers 532, 534 to move away from the actuator body 574 and a corresponding movement of the shutter 550 towards the actuator body 574. As the extension of the piston 572 continues, the shutter 550 continues to rotate about the pivot 538 towards the actuator body 574, exposing the window 562 until the window 562 is fully uncovered by the shutter 550, such as illustrated in Fig. 5D (i). To cover the window 562 with the shutter 550, the piston 572 is retracted towards the actuator body 574, rotating the shutter lever arm 530 about the pivot 538. This causes the fingers 532, 534 to move towards the actuator body 574 and a corresponding movement of the shutter 550 away from the actuator body 574 until the shutter 550 covers the window 562, such as illustrated by the dashed lines in Fig. 5D (ii). Fig. 5D (i) and (ii) are simplified diagrams showing the movement of the shutter 550 relative to the platform 560.

[0104] The shutter lever arm 530 may be configured to releasably engage with the shutter lever actuator 570, such as via the shutter lever wheel 540, to prevent opening of the source assembly support 500 when the window 562 is uncovered.

[0105] For example, in some embodiments, the shutter lever arm 530 is configured so that the source assembly support 500 can only be moved into the extended position when the shutter 550 covers the window 562. This configuration improves safety. The fingers 532, 534 may comprise fingertips 533, 535 that extend in a longitudinal direction substantially parallel with the axis of movement of the source assembly support 500 between the extended and contracted configurations. If these axes are misaligned, such as when the shutter lever arm 530 has been rotated to uncover the window 562, at least one of the fingertips 533, 535 engage or hook around a rear of the shutter lever wheel 540 and engage therewith, thereby restricting or preventing the extension of rails 510 and the associated movement of the source assembly support 500.

[0106] The fingers 532, 534 may be shaped to essentially “hook” around the shutter lever wheel 540 when the shutter 550 is open, thereby locking the shutter lever arm 530 and the source assembly support 500 into the contracted configuration. The fingers 532, 534 may be able to be unhooked from the shutter lever wheel 540 only when the shutter 550 is closed, thereby allowing opening of the source assembly support 500 (movement from the contracted configuration to the extended configuration).

[0107] The radioisotope generator 100 may comprise a controller to control one or more operations of the generator 100. The radioisotope generator 100 may comprise a position sensor. The controller may be configured to operate the shutter mechanism to move the shutter 550 to uncover the window 562 in response to a signal from the position sensor. For example, the signal may be indicative of the container movement mechanism 1000 lifting the first container 600. The controller may be configured to operate the shutter mechanism to move the shutter 550 to cover the window 562 in response to a signal from the position sensor. For example, the signal may be indicative of the container movement mechanism 1000 lowering or initiating lowering of the first container 600 or raising or initiating raising of the first container 600.

[0108] The source assembly support 500 may further comprise a retainer 580. The retainer 580 may be configured to engage with the platform 560 to restrict lateralmovement of the source shield assembly 410 when the source shield assembly 410 is received on the platform 560. As best shown in Figs. 4A and 4B, the retainer 580 may define an opening through which the source shield assembly 410 may pass through to be received on the platform 560. The opening of the retainer 580 may be shaped in conformity with the shape of the source shield assembly 410 to ensure a tight fit between the source shield assembly 410 and the retainer 580. Turning again to Figs. 5A, 5B and 5C, the retainer 580 may comprise a flange 582 at one side extending perpendicularly and / or upwardly to engage with the sliding mechanism, such as the rails 510.

[0109] Figs. 6A, 6B, and 6C show in more detail the first container 600 configured for receiving a radioisotope, according to some embodiments. As indicated, the radioisotope may, according to some embodiments, be emitted from the radioactive source 401 of the radioisotope generator 100 for receipt by the first container 600. Fig. 6A is a perspective view of a top portion of the first container 600, while Fig. 6B is a perspective view of a bottom portion of the first container 600. Fig. 6C is a section view showing an internal configuration of the first container 600, taken along the line 6C-6C marked on Fig. 6A.

[0110] In some embodiments, the first container 600 comprises a double wall arrangement. In some embodiments, the first container 600 may comprise an outer wall 610 and an inner wall 620. The inner wall 620 may be configured to be exposed to the radioisotope emitted from the radioactive source 401. The outer wall 610 may be configured to be connected to the inner wall 620 to allow handling of the first container 600 without contacting the inner wall 620 and / or to allow the inner wall 620 to take a shape that is not necessarily as suitable for handling as the shape of the outer wall. The outer wall 610 may be connected to the inner wall 620 at a bridge portion 630, e.g., at an upper position of the container 600. The outer wall 610, the inner wall 620, and the bridge portion 630 may be integrally formed in some embodiments.

[0111] The inner wall 620 may provide an inner surface 622 of the first container 600. In the source exposure position shown in Fig. 4B, wherein the first container 600 is positioned in the housing 110 adjacent to the radioactive source 401, the inner surface 622 of the first container 600 is configured to be exposed to the radioactive source 401 to receive the radioisotope.

[0112] The outer wall 610 may comprise a base portion 640. The base portion 640 may be configured to improve the stability of the first container 600 when the first container 600 is placed on a flat surface. The base portion 640 may be configured to enable secure holding and / or manipulation of the first container 600. The base portion 640 may be flared, in that at least part of the base portion 640 may extend beyond a perimeter of the outer wall 610 of the first container 600 to define a base flange. At least part of the base portion 640 may have a larger diameter than the outer wall 610 and be connected to the outer wall 610 to define a shoulder 642. The shoulder 642 may be shaped to engage with a corresponding engagement feature on a manipulator, such as a pair of tongs or collector arm 1002 (Fig. 10B).

[0113] The bridge portion 630 may comprise a lip 632. The lip 632 may be an extension of the inner wall 620. The lip 632 may extend around an upper opening of the container 600 and may provide an upper rim of the container 600. The lip 632 may be configured to receive a gasket or seal 634 that is configured to abut the ledge 426 of the source shield assembly 410 (Fig. 4B) when the first container 600 is received in the container recess 428 in the source exposure position. The seal 634 may be configured to deform when the first container 600 is in the source exposure position so that the inner surface 622 is adjacent to the radioisotope source 401 and the emitted radioisotope is directed to the exposed inner surface 622. The seal 634 may be made of a softer material than the first container 600 so as to reduce the risk of damaging the radioisotope source 401 when the first container 600 is manoeuvred into the source exposure position.

[0114] The inner wall 620, and particularly the inner surface 622, may at least partially define an internal volume such as an exposure chamber 650 that is at least substantially sealed when the first container 600 is in the source exposure position. The radioisotope may be a gas that is in gas communication with the exposure chamber 650. The radioisotope may be a gas that decays and is deposited as precipitate on the inner surface 622. The inner wall 620 may define an elution aperture 652 in fluid communication with an elution port 654. The elution port 654 may be a fluid path for fluid to flow therethrough. The elution port 654 may be an elution inlet and / or an elution outlet. The exposure chamber 650 may receive eluant configured to flush the exposure chamber 650. In embodiments where the radioisotope is a gas that decays and is deposited as precipitateon the inner surface 622, the eluant may dissolve or solubilise the precipitate on the inner surface 622 and form a radioisotope solution. In some embodiments, the inner surface 622 of the inner wall 620 has a substantially conical or frustoconical shape. The elution port 654 may be located at an apex of the conical or frustoconical shape of the inner surface 622, so that the inner surface 622 is configured to direct eluant towards the elution port 654, e.g. under the force of gravity and / or when subject to a vacuum force.

[0115] The exposure chamber 650 may receive eluant through the elution port 654. The elution port 654 may be disposed at or adjacent to a base of the first container 600, such as the base portion 640. The elution port 654 may receive the fluid connection for transferring eluant in and / or out of the first container 600. In some embodiments, the first container 600 may define a separate eluant inlet port (not shown). The eluant may drain out of the elution aperture 652 and through the elution port 654. The radioisotope on the exposed inner surface 622 may thereby be mixed with the eluant and collected via the elution port 654.

[0116] In some embodiments, the container 600 may have a wall and defining an exposure chamber without necessarily having a double walled configuration. For example, a container may have a wall configured similarly or identically to the inner wall 620 described above, without the container necessarily having an outer wall 610 as described above.

[0117] In some embodiments, the container movement mechanism 1000 of the radioisotope generator 100 is configured to cause movement of a second container 700, in addition to the first container 600, such as a second container 700 as shown in Fig. 7A and 7B. The container movement mechanism 1000 may move the second container 700 to and away from the source exposure position, wherein, in the source exposure position, the second container 700 is positioned in the housing 110 adjacent to the radioactive source 401 to receive the radioisotope.

[0118] As indicated further above, the second container 700 may be a dummy or blank container, which is configured to be positioned by the container movement mechanism 1000 in the source exposure position when the first container 600 is not positioned in the source exposure position. The second container 700 may be disposable, and generally used to prevent prolonged exposure of non-disposable parts of the generator to the sourcewhen the first container 600 is not receiving radioisotope, reducing the risk of damage or excessive build up of radioactivity

[0119] Fig. 7A and 7B shows the second container 700, according to some embodiments. Fig. 7A is a perspective view of a top portion of the second container 700, while Fig. 7B is a perspective view of a bottom portion of the second container 700. In some embodiments, the second container 700 may comprise a double wall arrangement. In some embodiments, the second container 700 may comprise an outer wall 710 and an inner wall 720. The inner wall 720 may be configured to be exposed to the radioisotope emitted from the radioactive source 401. The outer wall 710 may be configured to be connected to the inner wall 720 to allow handling of the second container 700 without contacting the inner wall 720 and / or to allow the inner wall 620 to take a shape that is not necessarily as suitable for handling as the shape of the outer wall. The outer wall 710 may be connected to the inner wall 720 at a bridge portion 730, e.g., at an upper position of the container 600. The outer wall 710, the inner wall 720, and the bridge portion 730 may be integrally formed in some embodiments.

[0120] The inner wall 720 may provide an inner surface 722 of the second container 700. In the source exposure position, the inner surface 722 of the second container 700 is configured to be exposed to the radioactive source 401 to receive the radioisotope.

[0121] The outer wall 710 may comprise a base portion 740. The base portion 740 may be configured to improve the stability of the second container 700 when the second container 700 is placed on a flat surface. The base portion 740 may be configured to enable secure holding and / or manipulation of the second container 700. The base portion 740 may be flared, in that at least part of the base portion 740 may extend beyond a perimeter of the outer wall 710 of the first container 670 to define a base flange. At least part of the base portion 740 may have a larger diameter than the outer wall 710 and be connected to the outer wall 710 to define a shoulder 742. The shoulder 742 may be shaped to engage with a corresponding engagement feature on a manipulator, such as a pair of tongs or collector arm 1002 (Fig. 10B).

[0122] The bridge portion 730 may comprise a lip 732. The lip 732 may be an extension of the inner wall 720. The lip 732 may extend around an upper opening of the container 700 and may provide an upper rim of the container 700. The lip 732 may beconfigured to receive a gasket or seal 734 that is configured to abut the ledge 426 of the source shield assembly 410 (Fig. 4B) when the second container 700 is received in the container recess 428 in the source exposure position. The seal 734 may be configured to deform when the second container 700 is in the source exposure position so that the inner surface 722 is predominately exposed to the emitted radioisotope. The seal 734 may be made of a softer material than the second container 700 so as to reduce the risk of damaging the radioisotope source 401 when the second container 700 is manoeuvred into the source exposure position.

[0123] The inner wall 720, and particularly the inner surface 722, may at least partially define an exposure chamber 750 that is at least substantially sealed when the first container 600 is in the source exposure position. The inner wall 720 may not be configured to allow drainage of eluant from the exposure chamber 750; that is, unlike the first container 600, the second container 700 does not define an elution aperture or an elution port. The radioisotope on the exposed inner surface 722 may thereby remain within the exposure chamber 750. The first container 600 and the second container 700 may be identical apart from the elution aperture or the elution port.

[0124] In some embodiments, the shutter 550 may open in response to or at least in synchronicity with an upward movement of the container movement mechanism 1000. This upward movement of the container movement mechanism 1000 may be indicative of lifting of the first container 600 towards the source exposure position and / or the second container 600 towards the source exposure position.

[0125] The first container 600 may be configured to be connected to a cap 800. The cap 800 may be configured to cover and / or seal a chamber of the first container 600, such as the exposure chamber 650 of the first container 600 described above, that receives eluant for elution of the received radioisotope when the first container 600 is in the position for elution of the received radioisotope . The cap 800 may prevent eluant from overflowing or splashing out of the exposure chamber 650. Figs. 8A and 8B are perspective views of the cap 800, while Figs. 9A and 9B show the cap 800 connected to the first container 600.

[0126] Fig. 8A is a perspective view of the cap 800 from an upper angle. The cap 800 may comprise a cap body 802 configured to cover the exposure chamber 650 of the first container 600, e.g. by extending across an upper opening of the exposure chamber 650.The cap 800 may comprise a cap flange 810 extending radially from the cap body 802, wherein the cap flange 810 is configured to be releasably retained by a holder 326 on the chassis 320 of the generator 100 (such as shown in Figs. 3 and 10A). The holder 326 may, in some embodiments, be a clamp or other similar device capable of releasably engaging and retaining the cap 800. The cap flange 810 may be configured to engage with the first container 600 to seal the chamber of the first container 600. In some embodiments, the cap flange 810 may define a circumferential groove 812 that is configured to receive the lip 632 of the first container 600. When the lip 632 is received in the groove 812 (such as shown in Fig. 9B), the seal 634 may be compressed to form a seal that is at least substantially airtight and / or watertight, thereby reducing or preventing the escape of air and / or liquid from the first container 600 through the interface between the lip 632 and the cap flange 810.

[0127] The cap 800 may comprise a vent 820 for venting the container 600, e.g. the exposure chamber 650 of the container. The vent 820 may be connected to a vent aperture defined in the cap body 802. A wall 804 may extend upwardly from the cap body 802 to surround the vent 820. The cap 800 may be configured to allow gas to escape from the first container 600 through the vent 820. The vent 820 may enable pressure inside the first container 600 to be adjusted, such as to be substantially equal to pressure outside the first container 600. For example, the vent 820 may allow for venting the chamber 650 when the chamber 650 receives the eluant. When eluant is received in the first container 600, the inflow of the eluant into the exposure chamber 650 may push air within the exposure chamber 650 out through the vent 820. When eluant is transferred out of the first container 600, air may enter the exposure chamber 650 through the vent 820.

[0128] The cap may comprise a cap tube 830 and a valve 840. The cap tube 830 may connect to the vent 820 to assist venting of the chamber 650. The cap tube 830 may direct the air vented through the vent 820 and out of the valve 840. The valve may be controlled, e.g., electronically controlled, to open and close at suitable times to allow air to enter or exit the exposure chamber. A filter 845, may be collocated with the valve 840 or cap tube 830 to remove any particulate matter from air before venting the air to outside the generator 100 or before air enters the container 600. The valve 845 may beconfigured to be connected to an external vent interface of the generator 100, which releases the air to outside the generator 100. In some embodiments, the external vent interface is disposed distal to the valve 840. The generator 100 may comprise a conduit to connect the valve 840 and the external vent interface.

[0129] Fig. 8B is a perspective view of the cap 800 from a lower angle. The cap 800 comprises a plug portion 850 configured to extend into the exposure chamber 650 of the first container 600 (such as shown in Fig. 9B). A side wall of the plug portion 850 may define the groove 812 in combination with the cap flange 810. The plug portion 850 may extend downwardly from the cap body 802, e.g., in an opposite direction to the wall 804.

[0130] When the cap 800 is connected to the first container 600, the plug portion 850 may extend into the exposure chamber 650 so as to reduce an open volume of the exposure chamber 650. Doing so reduces the amount of eluant required to fill the exposure chamber 650, and may expedite the filling and drainage of the eluant in the exposure chamber 650.

[0131] The plug portion 850 may comprise one or more separators 852 disposed on an outer surface 854 of the plug portion 850 and extending therefrom. The plug portion 850 may comprise a plurality of the separators 852, wherein the separators 852 are equally spaced around the plug portion 850 on the outer surface 854. The separator(s) 852 may be in the form of a small projection, such as a rib. With reference to Fig. 9B, when the plug portion 850 extends into the chamber 650, the separator(s) 852 are configured to abut the inner surface 622 of the first container 600, thereby separating or spacing apart the outer surface 854 and the inner surface 622 to define a reduced volume of chamber 650. The plug portion 850 may be shaped to correspond to the contours of the inner surface 622 of the first container 600. The outer surface 854 may have a shape substantially corresponding to a shape of the inner surface 622. Accordingly, in some embodiments, the shapes of the outer surface 854 and the inner surface 622 extend parallel to each other when the cap 800 seals the chamber 650, such as shown in Fig. 9B. The outer surface 854 and the inner surface 622 may each have substantially conical or frustoconical shapes such that the reduced volume of the chamber 650 is substantially conical or frustoconical in shape.

[0132] Various components, such as a variety of components as described above, which are used in conjunction with the generator, may form part of a disposable apparatus. The disposable apparatus may include components that are readily exposed to radioisotope during use, whether directly or during collection of radioisotope. The components of the disposable apparatus may be configured to be disposed safely after use. The disposable apparatus may be provided to a user in the form of a kit and may be provided in the same, single package before use. The disposable apparatus may include components such as one or more of: the first container 600, the second container 700, the cap 800, the tube 910 and the tube support 240. The disposable apparatus may include components that are used and replaced for every cycle in which the first container 600 is exposed to radioisotope and the radioisotope is subsequently collected via an elution process or otherwise.

[0133] Figs. 9A and 9B show an example of a disposable apparatus 900 for use with a radioisotope generator, such as the radioisotope generator 100. The disposable apparatus 900 as illustrated includes components as describe above, including the first container 600, the cap 800 and the tube 910, although it may include one or more alternative versions of these features along with additional features such as the second container 700 and the tube support 240.

[0134] In general, the disposable apparatus 900 may comprise a container 600 comprising a recess, wherein an inner surface of the recess may be configured to be exposed to a radioisotope emitted from a radioactive source in the radioisotope generator. The disposable apparatus 900 may comprise a cap 800 configured to engage with the container 600 to form a chamber between the cap and the inner surface. The chamber formed between the cap and the inner surface may be configured to be in fluid connection with an elution source to transfer the radioisotope to a fluidics handling system, wherein the elution source is configured such that an elution fluid from the elution source enters and exits the chamber through an elution port of the container.

[0135] The disposable apparatus 900 may further comprise a tube 910, such as shown in Fig. 9A. The tube 910 may be configured to supply eluant to the first container 600. The tube 910 may be configured to drain eluant from the first container 600. The tube 910 may be configured to supply and drain eluant in the first container 600. The tube 910may be an elution tube configured to be connected to the elution port 654 of the first container 600, such as shown in Fig. 9B. Fig. 9B is a section view taken along the line marked 9B-9B on Fig. 9A.

[0136] The disposable apparatus 900 may further comprise a tube support 240 to hold the tube in the housing of the generator such as shown in Figs. 1-3). The tube support 240 may be pre-mounted to the tube 910 and clipped into the housing of the generator to position the tube 910 within the generator during use.

[0137] Replacement of the disposable apparatus 900 is shown in more detail in Fig. 14, showing process flow diagram 1400, subsequently described in more detail herein.

[0138] Figs. 10A and 10B show the container movement mechanism 1000 according to one embodiment. In particular, Fig. 10A shows the container movement mechanism 1000 with the first container 600 and the cap 800. Fig. 10B is a section view taken along the line marked 10B-10B on Fig. 10A, showing the container movement mechanism 1000, the radioactive source assembly 400, and the cap 800. The first container 600 is omitted from Fig. 10B for a clearer view of the collector arm 1002 and its components. Fig. 10C shows a simplified schematic of the container movement mechanism 1000 in various positions, such as in Figs. 10C (i)-(v).

[0139] With reference to Fig. 10A and Fig. 10C (i), in some embodiments, the container movement mechanism 1000 is movable to a loading position for the first container. In the loading position for the first container 600, the container movement mechanism 1000 is adapted to receive the first container 600. For example, the first container 600 is configured to be releasably mounted to the container movement mechanism 1000. In the loading position for the first container 600, the first container 600 may be disposed adjacent the door 120 (such as shown in Fig. 2).

[0140] Fig. 10C (ii) shows the first container 600 after loading. Fig. 10C (ii) is also representative of the first container 600 when in a collection position, after movement of the first container 600 to and from a source exposure position as discussed further below.

[0141] In this embodiment, the cap 800 is connected to the first container 600 prior to loading and the cap 800 is received by the holder 326 at the same time as the first container 600 is received by the container movement mechanism 1000. However, inalternative embodiments the cap 800 and first container 600 may be positioned independently, e.g. if the loading position for the first container 600 is below the collection position that is illustrated in Fig. 10C (ii). In some embodiments, the cap 800 may be received in the holder 326 and the first container 600 raised to engage with the cap 800. In general, the loading position for the first container 600 may be at, adjacent to, or beneath the collection position.

[0142] The container movement mechanism 1000 may be configured to move the first container 600 from the loading position as illustrated in Fig. 10C(ii) to a source exposure position as illustrated in Fig. 10C(v).

[0143] The movement of the first container 600 between the loading position and the source exposure position may comprise a linear movement. The movement may comprise a rotational movement. The movement may comprise a linear movement and a rotational movement. The linear movement and the rotational movement may be sequential.

[0144] The first container 600 may be lowered from the loading position as illustrated in Fig. 10C(ii), disengaging the first container 600 and the cap 800. The cap 800 may remain engaged with the holder 326 as the first container 600 is disengaged from the cap 800, such as illustrated in Fig. 10C(iii). The cap 800 and the holder 326 may be disengaged by a linear movement. The linear movement may be part of a second lifting and lowering movement, as subsequently described.

[0145] The container movement mechanism 1000 may be configured to move the first container 600 between the loading position and / or collection position (Fig. 10C (iii)) and the source exposure position (Fig. 10C (v)). Fig. 10C (iv) shows the first container 600 moved away from the loading position but before the source exposure position, wherein the first container 600 is under the radioactive source assembly 400. The position illustrated in Fig. 10C (iv) may be a first position of the first container 600, wherein the radioactive source 401 in the radioactive source assembly 400 remains shielded by the shutter 550. From the first position the first container 600 may be moved to a source exposure position in which the shutter 550 is moved away, exposing the first container 600 to the radioactive source 401 within the radioactive source assembly 400. Fig. 10C (iv) shows the container movement mechanism 1000 in the first position beneath thesource exposure position. Fig. IOC (v) shows the container movement mechanism 1000 in the source exposure position.

[0146] In some embodiments, the linear movement comprises a first lifting and lowering movement. The first lifting and lowering movement may include lifting the first container 600 from the first position beneath the source exposure position to the source exposure position.

[0147] After the first container 600 has been exposed to the radioactive source 401 in the source exposure position, the first container 600 may be lowered to the first position illustrated in Fig. 10C (iv). The lowering of the first container 600 from the source exposure position to the first position may be part of the first lifting and lowering movement. The first container 600 may then be moved towards the collection position. The first container 600 may be moved to the second position beneath the collection position, similar to that as illustrated in Fig. 10C(iii).

[0148] The second lifting and lowering movement may include lifting the first container 600 from the second position beneath the collection position to the collection position. The second lifting and lowering movement may include lowering of the first container 600 from the collection position to the second position prior to the first container 600 being moved to the source exposure position. The second position may be different to the loading position. Fig. 10C (iii) shows the container movement mechanism 1000 in the second position beneath the collection position.

[0149] The movement of the first container 600 between the source exposure position and the collection position may comprise a linear movement. The movement may comprise a rotational movement. The movement may comprise a linear movement and a rotational movement. The linear movement and the rotational movement may be sequential.

[0150] The container movement mechanism 1000 may be configured to move the first container 600 between the source exposure position (Fig. 10C (v)) and the loading position and / or collection position (Fig. 10C(ii)). The movement of the first container 600 between the source exposure position and the collection position may comprise a linear movement. The movement may comprise a rotational movement. The movementmay comprise a linear movement and a rotational movement. The linear movement and the rotational movement may be sequential.

[0151] The container movement mechanism 1000 may be configured to move the first container 600 between the loading position and the collection position. The container movement mechanism 1000 may be configured to connect the first container 600 to the cap 800 when the first container 600 is moved to the collection position.

[0152] In some embodiments, a position sensor is connected to the container movement mechanism 1000 and configured to detect when the container movement mechanism 1000 is performing the linear movement of the first container 600.

[0153] In some embodiments, the container movement mechanism 1000 comprises a collector arm 1002 configured to releasably retain the first container 600. The collector arm 1002 may be configured to move the first container 600 between the source exposure position and the collection position. In some embodiments, the container movement mechanism 1000 comprises a collector arm 1002 configured to releasably retain the second container 700. The collector arm 1002 may be configured to move the second container 700 between the source exposure position and the collection position. In the embodiment illustrated in Fig. 10C (i) and (ii), the second container 700 is shown in the source exposure position. In the embodiment illustrated in Fig. 10C (iii), the second container 700 is lowered to the first position, and the shutter 550 is closed to shield the radioisotope source 401 in the radioisotope source assembly 400. In the embodiment illustrated in Fig. 10C (iv), the second container 700 is moved to the second position, and the first container 600 is moved to the first position. In the embodiment illustrated in Fig. 10C (v), the second container 700 is moved to be engaged with the cap 800, and the first container 600 is moved to the source exposure position.

[0154] The container movement mechanism 1000 may be configured to simultaneously move the first container 600 and the second container 700. The container movement mechanism 1000 may be configured to simultaneously position the first container 600 in the source exposure position and position the second container 700 in the collection position. The container movement mechanism 1000 may be configured to simultaneously position the second container 700 in the source exposure position and position the first container 600 in the collection position. The movement of the firstcontainer 600 between the source exposure position and the collection position may further comprise a rotational movement configured to rotate the first and second containers 600, 700 at least partially between the source exposure position and the collection position.

[0155] Turning to Fig. 10B, the collector arm 1002 may comprise a first holder 1010, wherein the first holder 1010 is configured to receive and hold the first container 600. The collector arm 1002 may comprise a second holder 1020, wherein the second holder 1020 is configured to receive and hold the second container 700.

[0156] The first holder 1010 and the second holder 1020 may be at opposite ends of the collector arm 1002. The collector arm 1002 may comprise a rotation axis 1004 disposed equidistant between the first holder 1010 and the second holder 1020. The collector arm 1002 may be configured to rotate about the rotation axis 1004. Rotation of the collector arm 1002 about the rotation axis 1004 may move the first holder 1010 between a position at or adjacent to the collection position and a position at or adjacent to the source exposure position. Rotation of the collector arm 1002 about the rotation axis 1004 may move the first container 600 and the second container 700 to exchange positions relative to the housing 110 of the generator 100.

[0157] The first holder 1010 and the second holder 1020 may be configured to releasably retain the first container 600 and the second container 700 respectively. The first holder 1010 and the second holder 1020 may respectively comprise a retention mechanism 1012, 1022. The first holder 1010 and the second holder 1020 may respectively comprise a receiving portion 1014, 1024. For example, the receiving portion 1014, 1024 may be shaped to receive the base portion 640, 740 of the respective containers 600, 700, such as shown in Fig. 10A. The retention mechanism 1012, 1022 may extend from the respective receiving portion 1014, 1024, so that when the base portion 640, 740 is received in the respective receiving portion 1014, 1024, the flared base portion 640, 740 presses against the retention mechanism 1012, 1022. A bias of the retention mechanism 1012, 1022 may then hold the base portion 640, 740 in the respective receiving portion 1014, 1024 of the holders 1010, 1020. In some embodiments, the retention mechanism 1012, 1022 is integrally formed with the receiving portion 1014, 1024, wherein the receiving portion 1014, 1024 is made from aelastically deformable material that is configured to deflect or deform slightly when the flared base portion 640, 740 is pushed into or pulled out of the receiving portion 1014, 1024. In some embodiments, the retention mechanism 1012, 1022 is provided by a spring-mounted ball catch that engages with the base portion 640, 740. Similar springmounted ball catches may be provided in the holder 326.

[0158] The container movement mechanism 1000 may comprise a lifting mechanism 1030. The lifting mechanism 1030 may comprise: (i) a scissor lift; (ii) a first linear actuator; and / or (iii) a belt or chain; configured to lift and lower the first container 600.

[0159] In the embodiment illustrated in Figs. 10A and 10B, the lifting mechanism 1030 includes a scissor lift 1040. The lifting mechanism 1030 may comprise a piston 1032 indirectly or directly connected to the scissor lift 1040. The scissor lift 1040 may comprise a scissor linkage 1042. The scissor lift 1040 may comprise a platform 1044 that supports the collector arm 1002. The platform 1044 allows the collector arm 1002 to rotate without rotating the scissor lift 1040. In some embodiments, the platform 1044 defines a track (not shown) configured to guide and support the collector arm 1002 during its rotation.

[0160] The scissor lift 1040 may comprise a pivot 1046 that is connected to the chassis 320 of the generator 100. The scissor lift 1040 may comprise a movable end 1048 that is configured to move relative to the chassis 320 and the pivot 1046. The piston 1032 may be connected to the movable end 1048, so that extension or retraction of the piston 1032 may cause extension or retraction of the scissor lift 1040, thereby lifting or lowering the platform 1044. The movable end 1048 may comprise a wheel configured to roll along the floor 310 of the generator 100 in response to extension or retraction of the piston 1032.

[0161] The scissor lift 1040 may, in some embodiments, be replaced by a piston that lifts or lowers the collector arm 1002.

[0162] The collector arm 1002 may be configured to rotate about a central shaft 1050 of the container movement mechanism 1000. The central shaft 1050 may be collinear with the rotation axis 1004. The container movement mechanism 1000 may comprise a gear system 1060 configured to cause rotation of the collector arm 1002. The gear system1060 may comprise a first gear 1062 configured to engage with a second gear 1064, wherein the first gear 1062 is fixedly connected to the collector arm 1002, while the second gear 1064 is rotatably connected to the chassis 320.

[0163] The lifting mechanism 1030 may lift and / or lower the collector arm 1002 to and from a rotatable configuration. Fig. 10A shows the collector arm 1002 in the rotatable configuration. In the rotatable configuration, the first gear 1062 and the second gear 1064 are engaged. Rotation of the second gear 1064 may cause a corresponding rotation of the first gear 1062, resulting in rotation of the collector arm 1002 about the central shaft 1050. In Fig. 10A, the first gear 1062 is shown in phantom as it is obscured by the first container 600. In Fig. 10B, the second gear 1064 is hidden behind the first gear 1062.

[0164] Out of the rotatable configuration, the first gear 1062 and the second gear 1064 are disengaged. The lifting mechanism 1030 may lift and / or lower the collector arm 1002 until the gears 1062, 1064 are no longer aligned. For example, when the first container 600 is raised into the collection position, the gears 1062, 1064 are disengaged and the collector arm 1002 is unable to rotate. Preventing rotation of the collector arm 1002 may thereby prevent accidental damage to the generator 100 when the first container 600 is in the collection position. Similarly, when the first container 600 or the second container 700 is in the source exposure position, the gears 1062, 1064 are disengaged and the collector arm 1002 is unable to rotate. Rotation may only occur when the first container 600 and the second container 700 are disengaged from the radioactive source assembly 400 and the cap 800 that are fixedly connected to the generator 100. The container movement mechanism 1000 may be configured to rotate the first container 600 between first position and the second position. In some embodiments, the second gear 1064 moves with the lifting and lowering of the collector arm 1002. In such embodiments, the second gear 1064 is also prevented from rotating the first gear 1062, and thereby preventing rotation of the collector arm 1002 when either of the first container 600 and the second container 700 are in the collection position and the source exposure position. A sensor may be used to indicate when the lifting mechanism 1030 is raised and lowered.

[0165] The lifting mechanism 1030 may comprise a piston indirectly or directly connected to the collector arm 1002. Extension of the piston may cause lifting of thecollector arm 1002, and retraction of the piston may cause lowering of the collector arm 1002. The container movement mechanism 1000 may comprise a conveyor configured to move the first container 600 between the source exposure position and the collection position.

[0166] Generators according to embodiments of the present disclosure may be designed to be housed in a radiation containment chamber such as a standard synthesis “hotcell”. Hotcells are used in nuclear-medicines industries. They protect individuals from radioactive isotopes by providing a safe containment box in which they can control and manipulate the equipment required, such as a generator for producing212Pb. Generators according to embodiments of the present disclosure may be designed to produce a radioisotope such as212Pb. Generation of the radioisotope may be on a 24 hour production cycle, for example. The generator 100 may generate a212Pb radioisotope that is produced by collecting220Rn gas that emanates from a228Th-containing source. The228Th-containing source may be held within a radiation shield inside the generator, such as source shield assembly 410 inside the generator 100. The228Th-containing source may be static during production, receipt and collection of the radioisotope.

[0167] The212Pb radioisotope may be extracted from the generator using disposable apparatus, such as single use kits as described above.

[0168] In some embodiments,212Pb radioisotope may be produced and collected from a plurality of generators configured, for example, in accordance with the generator 100 illustrated in the accompanying figures. The plurality of generators 100 may include respective sources 401, such as respective228Th-containing sources, with the212Pb radioisotope collected from each228Th-containing source 401 being pooled into a single extracted volume, e.g., as a bulk isotope stream. An example of a single extracted volume is reservoir 1120, subsequently shown in Fig. 11.

[0169] The212Pb bulk isotope stream may be dispensed into a reservoir such as a bulk isotope vial for use in processes intended to produce a material labelled with a212Pb radioisotope. Additionally, the212Pb bulk isotope stream may be directed into a reaction vessel for the production of radiopharmaceuticals.

[0170] Generators according to embodiments of the present disclosure may allow212Pb to be extracted in equilibrium, thereby decreasing total manufacture time and maximizing product efficiency and yield. The generators 100 may be fully automated and integrated with existing radiopharmaceutical manufacturing infrastructure, e.g., to deliver a 21 CFR 211 -compliant finished drug product.

[0171] Fig. 11 shows an system 1100 comprising a plurality of the generators 100 and a fluidics handling system 1110. The system 1100 may comprise three units of the generator 100 stacked on each other. The housing 110 of each of the generators 100 may be configured to facilitate stacking, for example by including corresponding engagement features for accurately positioning each generator 100 relative to each other. In some embodiments, the generators may be stacked directly on top of each other and / or located above each other by mounting on a rack. The engagement features and / or rack may suitably align the generators 100 in the stacked configuration.

[0172] Each one of the generators 100 may be connected to the fluidics handling system 1110 by a respective fluid connection 230. To help illustrate the fluidic connection of the generators 100, and particularly of a first container 600 located therein, to the fluidics handling system 1110, Fig. 11 shows one of the generators 100 with its door 120 in the open configuration. The first container 600 may contain a collected amount of a radioisotope that has been received from a radioactive source of the radioisotope generator 100, and the fluid connection 230 may then supply eluant to elute the radioisotope in the container 600 and direct the eluted radioisotope to the fluidics handling system 1110 by the fluid connection 230. The eluted radioisotope may be a212Pb solution formed by dissolving212Pb that precipitates upon decay of the220Rn gas. In some embodiments, the plurality of the generators 100 are configured to be in fluid connection with a reservoir 1120 of the fluidics handling system 1110. For example, the eluted radioisotope from a first one of the generators 100 and the eluted radioisotope from a second or further one of the generators 100 may be collected in the reservoir 1120. The reservoir 1120 may be a common pooled collection container. The reservoir 1120 may be a vial.

[0173] Fig. 12 shows an installation 1200 comprising a radiation containment chamber, which can be or include a “hotcell” 1210 for production of a radioisotope. Theinstallation 1200 may further comprise the elution system 1100. The hotcell 1210 is a shielded container which protects users from radiation emitted from a radioactive source within the hotcell 1210. The hotcell 1210 comprises a plurality of shielded walls 1220 defining an internal chamber 1230, an access panel 1240, and a viewing window (not shown) which allows the user to see the internal chamber 1230. The viewing window may be integrated into the access panel 1240 or separate from the access panel. The access panel 1240 may allow the user to operate or reach equipment within the internal chamber 1230. For example, the access panel may be a door 1240 of the hotcell 1210, which may be defined in at least one of the shielded walls 1220, wherein the door is openable to provide the user with access to the equipment within the internal chamber 1230, such as the generator(s) 100. When the door is closed, the closed door may form a seal with the surrounding portions of the shielded walls 1220 to minimise or prevent leakage of radiation from inside the hotcell 1210 to the outside environment. In some embodiments, the access panel is a removable panel (or set of panels) that is defined in at least one of the shielded walls 1220 to provide the user with access to the equipment within the internal chamber 1230, such as the generator(s) 100. When the panel is secured to the hotcell 1210, the secured panel may form a seal with the surrounding portions of the shielded walls 1220 to minimise or prevent leakage of radiation from inside the hotcell 1210 to the outside environment.

[0174] The hotcell 1210 may comprise a controller 1250 configured to receive signals relevant to the operation of the hotcell, for example based on one or more sensors. The generator 100 according to the present disclosure may be in communication with the hotcell controller 1250. The generator controller 1310 may be referred to as a first controller and the hotcell controller 1250 may be referred to as a second controller. The generator 100 may send instructions to the hotcell controller 1250, e.g., based on signals from one or more sensors of the generator 100. The hotcell controller 1250 may operate safety systems of the hotcell, such as a door interlock 1242 of the hotcell door 1240. Operation of the door interlock 1242 may be via a door interlock controller, wherein the hotcell controller 1250 may comprise the door interlock controller. In embodiments in which the hotcell comprises a plurality of the doors 1240, each of the doors 1240 may comprise individual door interlocks or a common door interlock, wherein the door interlock controller may be configured simultaneously or independently operate the doorinterlock for each of the doors 1240. The door interlock 1242 may be adjustable or movable from a locked to unlocked configuration to allow opening of the hotcell door 1240, or from an unlocked to locked configuration to prevent opening of hotcell door 1240, based on the instructions sent by the generator 100. The instructions sent by the generator 100 may comprise one or more instruction signals.

[0175] In some embodiments, the hotcell 1210 contains a fluidics handling system 1110 and a radioisotope generator 100. In some embodiments, the hotcell 1210 contains the system 1100 described above with reference to Fig. 11. The viewing window (not shown) may comprise at least one access window (not shown) configured to allow an operator to operate the elution system 1100. The access window (not shown) may be configured to allow an operator to operate the elution system 1100 without compromising the shielded internal chamber 1230. The fluidics handling system 1110 may be a radiosynthesizer 1110. The fluidics handling system 1110 may be configured to elute a radioisotope that has been collected from a radioactive source of the radioisotope generator 100. The fluidics handling system 1110 may be a disposable cassette radiosynthesizer. A hotcell 1210 may accommodate 2, 3, 4, 5, 6 or more generators 100 plus the fluidics handling system 1110. For example, two stacks each of three generators 100 may be accommodated by the hotcell 1210.

[0176] Fig. 13A is a block diagram 1300 showing operation of the generator 100, according to some embodiments. The generator 100 may comprise a controller 1310, such as a programmable logic controller (PLC). The generator 100 may comprise a sensor module 1320. The sensor module 1320 may comprise one or a plurality of sensors. One or more of the sensors may be located inside the generator 100 to detect conditions inside the generator 100. Additionally or alternatively, one or more of the sensors may be located outside the generator 100 to detect conditions outside the generator 100. The sensor module 1320 may include a position sensor 1322. The position sensor 1322 may be the position sensor as described above, configured to detect a position of the container movement mechanism 1000 inside the generator 100. The sensor module 1320 may include an accelerometer 1324. The accelerometer 1324 may, for example, provide information regarding movement of the container movement mechanism 1000. The accelerometer 1324 may provide information regarding the rate ofmovement of the container movement mechanism 1000. The accelerometer 1324 may provide information regarding the orientation of the generator 100, so that, for example, the generator 100 may not be operated if it is not on a level or stable surface. The sensor module 1320 may include one or more radiation or radioactive gas sensors such as a thoron (220Rn) sensor, as discussed further below.

[0177] In some embodiments, the sensor module 1320 may comprise one or more sensors associated with the shutter 550 to indicate an open position and a closed position of the shutter 550. In some embodiments, the sensor module 1320 may comprise one or more sensors associated with the container movement mechanism 1000 to indicate movement of the container movement mechanism 1000. In some embodiments, where the container movement mechanism 1000 comprises a scissor lift 1040 to raise and lower the containers 600, 700, the one of more sensors of the sensor module 1320 may indicate raising and lowering of the scissor lift 1040. In some embodiments, where the container movement mechanism 1000 comprises a rotating collector arm 1002, the one or more sensors of the sensor module 1320 may indicate when the collector arm 1002 (for example, the first holder 1010) has rotated to the first position and has rotated to the second position. In some embodiments, one or more sensors of the sensor module 1320 may be associated with the container movement mechanism 1000 to indicate when the first and / or second container 600, 700 is mounted to the container movement mechanism 1000. In some embodiments, one or more sensors of the sensor module 1320 may be associated with the container movement mechanism 1000 to indicate when the first and / or second container 600, 700 is connected to the cap 800. In general, any number of sensors may be comprised in the generator to check that the generator is functioning correctly.

[0178] The controller 1310 may comprise a processor 1312 in communication with memory 1314 storing instructions 1316 in accordance with software 1318. The software 1318, when executed, delivers the instructions 1316 to cause the controller 1310 to trigger operations of the generator 100, such as the opening of the shutter 550 to coincide with activation of the scissor lift 1040. The generator 100 may comprise a control panel 1330 for a user to operate the generator 100.

[0179] The generator 100 may further comprise a pneumatic system 1340. The pneumatic system 1340 may be operated by the controller 1310. The pneumatic system 1340 may be configured to operate the container movement mechanism 1000. The controller 1310 may operate the pneumatic system 1340, e.g., when the position of items of components of the generator as sensed by the sensor module 1320 are correct. The pneumatic system 1340 may experience relatively low operational interference associated with the radiation emitted from the radioisotope source 401, thereby improving operational reliability compared to electronic systems.

[0180] The generator 100 may comprise a vacuum connection configured to connect the first container 600 to a vacuum pump when located at the source exposure location. The vacuum pump may draw air out of the first container 600. The vacuum pump may generate a vacuum in the first container 600.

[0181] In some embodiments, as indicated, the sensor module 1320 may comprise at least one radiation or radioactive gas sensor such as at least one thoron sensor 1326. The radioactive gas sensor 1326 may be configured to measure a level (e.g., an absolute level or a concentration) of radioactive gas, such as thoron, originating from the radioactive source 401. Thoron is a hazardous radioactive gas that originates during production of a lead-212 (212Pb) isotope. As noted previously, the radioactive source 401 may be a thorium source, specifically a228Th-containing source from which thoron / radon gas (220Rn gas) emanates upon decay of the228Th-containing source to radium-224 (224Ra) and the decay of the224Ra to220Rn.

[0182] At least one radioactive gas sensor 1326 (e.g., thoron sensor 1326) may be positioned inside the housing 110 of the generator 100 to measure a level of radioactive gas inside the generator 100. At least one radioactive gas sensor 1326 may be positioned at least partially outside the housing 110 of the generator 100 (e.g. located on an outer surface of the generator housing 110) to measure a level of radioactive gas outside the generator 100, such as inside the chamber of the hotcell 1210. Some embodiments may comprise a first one of the radioactive gas sensors 1326 positioned inside the housing 110 of the generator 100 and a second one of the radioactive gas sensors 1326 positioned at least partially outside the housing of the generator 100. Each of the one or more radioactive gas sensors 1326 may be in communication with the generator controller1310, e.g., via an extended lead or a wireless connection. In some embodiments, the connection may allow the radioactive gas sensor 1326 to be mounted anywhere in the hotcell 1210 as appropriate, while still in communication with the controller 1310.

[0183] The one or more radioactive gas sensors 1326 of the sensor module 1320 may be in communication with the controller 1310 so that the controller 1310 receives information from the one or more radioactive gas sensors 1326 about the level or concentration of radioactive gas (e.g. thoron) present inside the housing of the generator 100 and / or in a region outside of the housing of the generator, such as the chamber of the hotcell 1210. If the radioactive gas level or concentration detected inside the generator 100 meets a hazard criterion (e.g. exceeds a threshold radioactive gas level), the controller 1310 may make a decision, and send a signal, to lock, or maintain locking, of the door of the generator 100 until the level of radioactive gas inside the generator 100 falls below the specified limit. Additionally or alternatively, if the radioactive gas level detected outside the generator 100, in the chamber of the hotcell 1210, meets a hazard criterion (e.g. exceeds a threshold radioactive gas level), the controller 1310 may make a decision, and send a signal to lock, or maintain locking, of the door of the hotcell 1210 until the level of radioactive gas outside the generator 100 and inside the hotcell 1210 falls below the specified limit. In some embodiments, the controller 1310 may make a decision, and send a signal, to unlock, or maintain unlocking, of the door of the generator 100 or the door of the hotcell 1210 when the radioactive gas level(s) meet a safe criterion (e.g. below a threshold radioactive gas level).

[0184] In some embodiments, the sensor module 1320 may comprise the door sensor as described above, which detects if the door 120 of the generator 100 is in the open or closed configuration. If the door sensor detects that the door 120 is in the open configuration, the controller 1310 may make a decision, and send a signal, to lock or maintain locking of the door of the hotcell 1210. If the door sensor detects that the door 120 is in the closed configuration, the controller 1310 may make a decision, and send a signal, to unlock or maintain unlocking of the door of the hotcell 1210.

[0185] In some embodiments, the generator 100 may include a delay timer 1350 in communication with the controller 1310. The delay timer 1350 may be configured to monitor a time period to enable the controller 1310, based on the monitored time period,to make a decision, and send a signal, to control locking of the door 120 of the generator 100 and / or locking of the door of the hotcell 1210. For example, the control may be such that the door(s) of the generator 100 and / or hotcell 1210 cannot be opened until a certain time period has expired. The time period may be a minimum time period after closure of the source shield assembly 410 commences, for example. As noted above, exposure of the container 600, 700 to the radioactive source 401 may be prevented or minimised if the source shield assembly 410 is closed when the door 120 is in the open configuration. The delay after closure of the source shield assembly 410 commences may provide time for the shutter 500 to fully cover and close the radioactive source 401 and thereby reduce risk of operator exposure to x-ray, alpha, beta and gamma radiation levels. As another example, the time period may be a minimum time period after closure of door 120 of the generator 100 commences or is completed.

[0186] In some embodiments, the generator 100 may include a power state sensor 1352 in communication with the controller 1310. The power state sensor 1352 may measure a power state of the generator 100, for example if power supplied to the generator 100 meets a hazard criterion such as being too high, too low, or irregular, or meets a safe criterion, such as being at a substantially constant suitable level. If the power state detected meets the hazard criterion, the controller 1310 may make a decision, and send a signal, to lock or maintain locking of the door 120 of the generator 100 and / or lock or maintain locking of the door of the hotcell 1210. If the power state detected meets the safety criterion, the controller 1310 may make a decision, and send a signal, to unlock or maintain unlocking of the door 120 of the generator 100 and / or unlock or maintaining unlocking of the door of the hotcell 1210.

[0187] In some embodiments, the generator may include a radiation sensor in communication with the controller 1310, to detect whether at least one type of radiation, e.g., (i) x-ray radiation; (ii) alpha radiation; (iii) beta radiation; and / or (iv) gamma radiation, is at or above a predefined threshold. If the level of radiation is at or above the threshold, the controller 1310 may make a decision, and send a signal, to lock or maintain locking of the door of the hotcell 1210.

[0188] The controller 1310 may control the lock on the generator door 120 and / or control the lock on the door of the hotcell 1210, if a hazard or safe criterion is met basedon any one or a combination of readings from the position sensor 1322, accelerometer 1324, radioactive gas sensor 1326, delay timer 1350, radiation sensor, and power state sensor 1352 or any other sensors that may be employed.

[0189] Fig. 13B is a block diagram showing the interaction between the generator controller 1310 and the hotcell controller 1250 (and particularly, in this example, the arrangement being repeated for a plurality of generators 100 located in respective hotcell chambers 1230, each with a hotcell controller, hotcell door 1240 and door interlock 1242). As described, each generator controller 1310 may receive signals from one or more of the position sensor 1322, accelerometer 1324, radioactive gas sensor 1326, delay timer 1350, and power state sensor 1352. Using digital logic, for example, the generator controller 1310 processes this information and may, based on whether certain hazard or safe criterion are met, instruct the respective hotcell controller 1250 to activate or deactivate the hotcell door interlock 1242 to achieve the locking or unlocking.Mechanical actuation may shift the hotcell door interlock 1242 from a locked to unlocked configuration to allow opening of hotcell door 1240, or from an unlocked to locked configuration to prevent opening of hotcell door 1240.

[0190] Having the generator controller 1310 configured to make decisions based on sensor information and provide instructions to the hotcell controller 1250 may allow the generator 100 to interact with standard hotcell control software. This may provide the advantage of compatibility with existing hotcell systems, reducing integration risk while still achieving a desired safety outcome. For example, it may not be necessary to modify the control software of the hotcell controller 1250 to interpret sensor information and make safety decisions.

[0191] As indicated, Fig. 13B shows a multi-chamber hotcell arrangement, each chamber 1230 having a respective hotcell door 1240. In some embodiments, a supervisory control 1360 may be provided to control the interlocks 1242 of the hotcell doors 1240. For example, the supervisory control 1360 may ensure that, if the generators 100 show conflicting safety readings, the doors 1240 of each chamber 1230 are instructed to be locked or remain locked. For example, if a first one of the generators 100 identifies that radioactive gas levels are within acceptable limits, but a second one of the generators 100 indicates that the radioactive gas levels are not within acceptable limits, all doors1240 of the multi-chamber hotcell arrangement may be instructed to be locked or maintained locked. Once the supervisory controller 1360 confirms from all generators 100 that the door 1240 is safe to open, the hot cell door interlocks 1242 may be instructed to be released.

[0192] Fig. 14 is a process flow diagram 1400 showing how disposable apparatus, such as the disposable apparatus 900 of Fig. 9A and 9B, may be removed from and replaced in the generator according to some embodiments.

[0193] At 1410, the operator checks that the generator 100 has positioned the first container 600 in a suitable position adjacent to the door 120, e.g. the first container 600 being in the collection position after radioisotope in the first container 600 has been subjected to an elution and collection process. If so, the door 120 of the generator 100 is opened.

[0194] At 1420, the operator disconnects the fluid connection 230 of the generator 100 from the fluidics handling system 1110. At 1430, the apparatus 900 (comprising the cap 800 still attached to seal the first container 600, fluid connection 230 (e.g. tube 910) and tube support 240) is disconnected from the generator 100 and discarded. At 1440, the operator sets the generator 100 into the loading position. In the loading position, the collector arm 1002 may be lowered away from the holder 326 which is configured to hold the cap 800. This may also move the second container 700 away from the radioactive source assembly 400 within the generator 100.

[0195] At 1450, a new set of the disposable apparatus 900 is installed. At 1452, the cap 800 may be installed first. The vent / filter 840 may be connected to an external vent interface 340 of the generator 100 and the flange 810 may be connected to the holder 326. At 1454, the first container 600 is connected to the collector arm 1002. Fluid connection 230 (which may comprise tube 910) is connected to the first container 600 via the elution port 654. Fluid connection 230 is connected to the tube support 240, which is connected to the housing 110 of the generator 100. At 1456, the fluid connection 230 is connected to the fluidics handling system 1110.

[0196] At 1460, the operator sets the generator 100 to rotate the collector arm 1002, moving the first container 600 beneath the radioactive source assembly 400 and movingthe second container 700 into the loading position towards the open door 120. At 1470 the second container 700 is removed and replaced with a new one of second container 700.

[0197] At 1480, the operator sets the generator 100 to raise the collector arm 1002 for the first container 600 to begin collecting radioisotope from the radioactive source 401. At 1490, the operator closes the door 120 of generator 100.

[0198] It will be appreciated by persons skilled in the art that numerous variations and / or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1. A radioisotope generator, comprising: a housing; a radioactive source region located in the housing and configured to receive a radioactive source emitting a radioisotope; and a container movement mechanism located in the housing and configured to cause movement of a first container between:(i) a source exposure position, wherein the first container is positioned in the housing adjacent to the radioactive source, and wherein an internal surface of the first container is configured to be exposed to the radioactive source to receive the radioisotope; and(ii) a collection position, wherein the first container is positioned in the housing for elution of the received radioisotope.

2. The radioisotope generator of claim 1, comprising a first fluid connection configured to transfer eluted radioisotope from the first container located in the collection position to a remote collection location.

3. The radioisotope generator of claim 1 or claim 2, wherein the container movement mechanism is movable to a loading position wherein the first container is configured to be releasably mounted to the container movement mechanism.

4. The radioisotope generator of claim 3, wherein the loading position is at, adjacent to, or beneath the collection position.

5. The radioisotope generator of any one of claims 1 to 4, wherein the container movement mechanism is configured to connect the first container to a cap when the first container is at the collection position, the cap configured to cover a chamber of the first container that receives eluant for elution of the received radioisotope.

6. The radioisotope generator of claim 5, wherein the cap comprises a vent for venting the chamber when the chamber receives the eluant.

7. The radioisotope generator of any one of claims 1 to 6, wherein the container movement mechanism is configured to move the first container between the source exposure position and the collection position by a movement comprising a linear movement and / or rotational movement.

8. The radioisotope generator of claim 7, wherein the linear movement comprises a first lifting and lowering movement including: (i) lifting the first container from a first position beneath the source exposure position to the source exposure position; and (ii) lowering the first container from the source exposure position to the first position.

9. The radioisotope generator of claim 7 or 8, wherein the linear movement comprises a second lifting and lowering movement including: (i) lifting the first container from a second position beneath the collection position to the collection position and (ii) lowering the first container from the collection position to the second position.

10. The radioisotope generator of claim 9, when dependent on claim 8, wherein the container movement mechanism is configured to rotate the first container between the first position and the second position.

11. The radioisotope generator of any one of claims 7 to 10, wherein the container movement mechanism comprises: (i) a scissor lift; (ii) a first linear actuator; and / or (iii) a belt or chain; configured to lift and lower the first container.

12. The radioisotope generator of any one of the preceding claims, wherein the container movement mechanism comprises a collector arm configured to releasably retain the first container and move the first container between the source exposure position and the collection position.

13. The radioisotope generator of claim 12, when dependent on claim 9, wherein the collector arm is configured to rotate to move the first container from the first position to the second position.

14. The radioisotope generator of claim 13, wherein the collector arm is configured to rotate about a central shaft of the container movement mechanism.

15. The radioisotope generator of any one of claims 12 to 14, wherein the collector arm is configured to releasably retain a second container, the container movement mechanism configured to cause movement of the second container between:(i) the source exposure position, wherein the second container is positioned in the housing adjacent to the radioactive source, and wherein an internal surface of the second container is configured to be exposed to the radioactive source to receive the radioisotope; and(ii) a collection position, wherein the second container is positioned in the housing for collection of the received radioisotope.

16. The radioisotope generator of claim 15, wherein the container movement mechanism is configured to simultaneously move the first container and the second container.

17. The radioisotope generator of claim 16, wherein the container movement mechanism is configured to simultaneously: (i) position the first container in the source exposure position and position the second container in the collection position; or (ii) position the second container in the source exposure position and position the first container in the collection position.

18. The radioisotope generator of any one of claims 15 to 17, wherein the movement of the first container between the source exposure position and the collection position further comprises a rotational movement configured to rotate the first and second containers at least partially between the source exposure position and the collection position.

19. The radioisotope generator of any one of claims 1 to 18, wherein the radioactive source is configured to be accessed through an opening in a first side of the housing.

20. The radioisotope generator of claim 19, wherein the generator comprises an access panel, the access panel movable or removable to enable access to an interior region of the generator through the opening.

21. The radioisotope generator of claim 19 or claim 20, wherein the generator comprises a source support for supporting the radioactive source within the housing, the source support being slidably mounted to the housing.

22. The radioisotope generator of claim 21, wherein the source support is mounted on a sliding rail mechanism having: (i) a contracted configuration wherein the source support is within the housing; and (ii) an extended configuration wherein the source support is located at least partially outside the opening in the first side of the housing.

23. The radioisotope generator of claim 22, wherein the source support comprises a locator pin for alignment of the source support within the housing when the sliding rail mechanism is in the contracted configuration.

24. The radioisotope generator of any one of claims 1 to 23, wherein the generator further comprises:(i) a source shield assembly containing the radioactive source, the source shield assembly defining an aperture through which the radioactive source emits the radioisotope; and(ii) a shutter movable between a closed state, wherein the shutter covers the aperture to form a gas-tight compartment containing the radioactive source; and an open state, wherein the shutter uncovers the aperture to allow the radioactive source to be in gas communication with an interior volume of the first container.

25. The radioisotope generator of claim 24 when dependent on claim 7, further comprising a controller and a position sensor, the position sensor connected to the container movement mechanism and configured to detect when the container movement mechanism is performing the linear movement of the first container.

26. The radioisotope generator of claim 25, wherein the controller is configured to operate a shutter mechanism to move the shutter to: (i) uncover the aperture in response to a signal from the position sensor indicative of the container movement mechanism lifting the first container; and (ii) cover the aperture in response to a signal from the position sensor indicative of the container movement mechanism lowering the first container.

27. The radioisotope generator of claim 26 when dependent on claim 22, wherein the shutter mechanism is a shutter lever arm configured to releasably engage with a shutter lever actuator to prevent movement of the sliding rail mechanism from the contracted configuration when the aperture is uncovered.

28. The radioisotope generator of any one of claims 19 to 27, wherein a top surface of the housing is configured to support a second one of the radioisotope generator, wherein the opening in the first side of the housing remains accessible when the second radioisotope generator is supported on the top surface.

29. The radioisotope generator of any one of claims 22 to 28, wherein the housing comprises a door providing access to the container movement mechanism through a second side of the housing.

30. The radioisotope generator of any one of the preceding claims, comprising a pneumatic system configured to operate the container movement mechanism.

31. The radioisotope generator of any one of the preceding claims, comprising a vacuum connection configured to connect the first container to a vacuum pump when located at the source exposure location.

32. The radioisotope generator of any one of the preceding claims, comprising a second fluid connection configured to transfer eluant to the first container when located at the collection position.

33. A radioisotope generator system, comprising:a housing containing therein; a radioactive source having an emanation surface from which radioisotope gas can emanate upon decay of the radioactive source; a source shield assembly for containing the radioactive source and reducing alpha and gamma radiation levels outside of the housing that result from decay of the radioactive source, which source shield assembly has a closed state in which the radioactive source is entirely contained within an gas-tight compartment therein; and a collection container having an interior volume for collecting radioisotope gas emanating from the radioactive source and an interior wall for collecting radioisotope precipitating as a solid from decay of the radioisotope gas in the interior volume; wherein the system further includes: an adjustable closure for reversibly providing the radioactive source between (i) being in gas communication with the interior volume of the collection container, and (ii) being disposed in the closed state of the source shield assembly; at least one fluid path for: introducing a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the radioisotope precipitated on the interior wall and form a radioisotope solution; and to remove the radioisotope solution from the collection container, wherein the at least one fluid path is configured to be operable while the collection container is disposed within the housing.

34. The radioisotope generator system of claim 33, wherein the at least one fluid path is configured to sequentially operate as:(i) an elution inlet, configured to introduce a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the radioisotope precipitated on the interior wall and form the radioisotope solution; and(ii) an elution outlet, configured to drain the radioisotope solution from the interior volume.

35. The radioisotope generator system of claim 33 or claim 34, wherein the at least one fluid path is configured to direct the radioisotope solution to a common pooled collection container.

36. The radioisotope generator system of any one of claims 33 to 35, wherein the radioactive source is a228Th-containing source.

37. The radioisotope generator system of claim 36, wherein the radioisotope gas is220Rn gas emanating upon decay of the228Th-containing source to224Ra and the decay of the224Ra to220Rn.

38. The radioisotope generator system of claim 37, wherein the radioisotope that is precipitating as a solid from decay of the220Rn gas is212Pb.

39. The radioisotope generator system of claim 38, wherein the radioisotope solution is a212Pb solution.

40. An interconnected radioisotope generator system, comprising a plurality of the radioisotope generator of any one of claims 1 to 32, or comprising a plurality of the radioisotope generator system of any one of claims 33 to 39, each one of the plurality of the radioisotope generator or the plurality of the radioisotope generator systems being configured to direct radioisotope solution to a common pooled collection container.

41. A radioisotope generator system, comprising: a housing containing therein; a228Th-containing source having an emanation surface from which220Rn gas can emanate upon decay of the228Th to224Ra and the224Ra to220Rn; a source shield assembly for containing the228Th-containing source and reducing alpha and gamma radiation levels outside of the housing that result from decay of the228Th, which source shield assembly has a closed state in which the228Th-containing source is entirely contained within an gas-tight compartment therein; anda collection container having an interior volume for collecting220Rn gas emanating from the228Th-containing source and an interior wall for collecting 212Pb precipitating as a solid from decay of the220Rn gas in the interior volume; wherein the system further includes: means for reversibly providing the228Th-containing source between (i) being in gas communication with the interior volume of the collection container, and (ii) being disposed in the closed state of the source shield assembly; means for introducing a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the212Pb precipitated on the interior wall and form a212Pb solution; and means to remove the212Pb solution from the collection container, wherein the means is configured to be operable while the collection container is disposed within the housing.

42. The radioisotope generator system of claim 41, wherein the means for introducing a fluid is configured to sequentially operate as:(i) an elution inlet, configured to introduce a fluid into the interior volume and into contact with the interior wall of the collection container to dissolve the212Pb precipitated on the interior wall and form the212Pb solution; and(ii) an elution outlet, configured to drain the212Pb solution from the interior volume.

43. The radioisotope generator system of claim 41 or claim 42, wherein the means for introducing a fluid is configured to direct the212Pb solution to a common pooled collection container.

44. Disposable apparatus for use with a radioisotope generator, the apparatus comprising: a first collection container comprising a first collection recess, an inner surface of the first collection recess configured to be exposed to a radioisotope emitted from a radioactive source in the radioisotope generator; a cap configured to engage with the first collection container to form a first collection chamber between the cap and the inner surface;wherein the first collection chamber is configured be in fluid connection with an elution source to transfer the radioisotope to a fluidics handling system, wherein the first collection container is configured such that an elution fluid from the elution source enters and exits the first collection chamber through at least one elution port of the first collection container.

45. The apparatus of claim 44, wherein the at least one elution port is at a base of the first collection container.

46. The apparatus of claim 45, wherein the base of the first collection container extends beyond a perimeter of an outer wall of the first collection container to define a base flange.

47. The apparatus of any one of claims 44 to 46, wherein the at least one elution port is a single elution port configured to provide entry of the elution fluid into the first collection container and subsequently, drainage of the elution fluid from the first collection container.

48. The apparatus of any one of claims 44 to 47, wherein the cap comprises a plug portion configured to extend into the first collection chamber.

49. The apparatus of claim 48, wherein the plug portion has an outer surface having a shape substantially corresponding to a shape of the inner surface.

50. The apparatus of claim 49, wherein the shapes of the outer and inner surfaces extend parallel to each other when the cap seals the first collection chamber.

51. The apparatus of claim 49 or claim 50, wherein the outer surface and the inner surface each have substantially conical or frustoconical shapes.

52. The apparatus of claim 51, wherein the at least one elution port is located at an apex of the conical or frustoconical shape of the inner surface.

53. The apparatus of any one of claims 44 to 52, wherein the cap comprises a cap flange defining a groove configured to engage with a lip of the first collection container to seal the first collection container.

54. The apparatus of any one of claims 44 to 53, comprising an elution tube configured to be connected to the at least one elution port.

55. The apparatus of claim 54, comprising a tube support connected to the elution tube and configured to support the elution tube in a housing of a radioisotope generator.

56. The apparatus of any one of claims 44 to 55, wherein the cap comprises a vent for venting the first collection chamber.

57. The apparatus of claim 56, wherein the vent comprises a filter.

58. The apparatus of claim 56 or 57, comprising a cap tube, the cap tube connecting to the vent to assist venting of the first collection chamber.

59. The apparatus of any one of claims 44 to 58, further comprising a second collection container.

60. The apparatus of claim 59, wherein the second collection container is a blank container comprising a second collection recess, an inner surface of the second collection recess configured to be exposed to the radioisotope; wherein the second collection container is configured to engage with the cap to form a second collection chamber between the cap and the inner surface, the second collection chamber being fluidly sealed to contain the radioisotope deposited on the inner surface.

61. A radioisotope generator, comprising: a housing configured to locate within an internal volume of a radiation containment chamber;a radioactive source region located in the housing and configured to receive a228Th radioactive source emitting a gaseous220Rn radioisotope; one or more sensors configured to provide one or more measurements relating to the amount of gaseous220Rn radioisotope within the housing of the radioisotope generator and / or within the internal volume of the radiation containment chamber in which the radioisotope generator is configured to be located; a first controller configured to receive the one or more measurements from the one or more sensors and send an instruction signal to a door interlock controller of the radiation containment chamber based on the one or more measurements; wherein the first controller, based on an amount of gaseous220Rn radioisotope measured by the one or more sensors being at or above a predetermined threshold level, provides the instruction signal to the door interlock controller to lock or maintain locking of one or more doors of the radiation containment chamber.

62. The radioisotope generator of claim 61, wherein the first controller is configured to determine if at least one of x-ray, alpha, beta or gamma radiation is above a predefined threshold level within the housing of the radioisotope generator and / or within the internal volume of the radiation containment chamber and control locking of the one or more doors of the radiation containment chamber based on the determination.

63. The radioisotope generator of any one of claims 61 to 62, comprising one or more additional sensors selected from:(i) a position sensor configured to detect a position of a container movement mechanism inside the housing;(ii) an accelerometer configured to detect a rate of movement of a container movement mechanism inside the housing;(iii) a delay timer configured to monitor a time period associated with operation of a door or lid of the housing; and / or(iv) a power state sensor configured to measure a power state of the generator; wherein the first controller is configured to control locking of the one or moredoors of the radiation containment chamber based on one or more signals received from the one or more additional sensors.

64. The radioisotope generator of any one of claims 61 to 63, wherein the radioisotope generator is a radioisotope generator according to any one of claims 1 to 43.

65. The steps, features, integers, compositions and / or compounds disclosed herein or indicated in the specification of this application individually or collectively, and any and all combinations of two or more of said steps or features.

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