Systems, methods, and apparatus for the delivery of therapeutic or diagnostic agents.

Abstract

Systems and methods are disclosed for dispensing, storing, transporting, administering, and / or disposing of one or more therapeutic or diagnostic agents. A storage device configured to connect to a delivery system for delivering a therapeutic or diagnostic agent includes a housing having a chamber and a container having an access port disposed within the chamber. A door is movable relative to the housing between a closed position and an open position. In the closed position, the door covers an opening in the housing to seal the chamber, and in the open position, the door exposes an opening for accessing the access port of the container. The door is movable between the closed position and the open position in response to actuation by an access mechanism of the delivery system.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 312,145, filed on February 21, 2022, and U.S. Provisional Application No. 63 / 312,14, filed on February 21, 2022, the disclosures of which are hereby incorporated by reference in their entireties.

[0002] The present disclosure relates to systems and methods for the packaging, dispensing, storage, administration, and / or disposal of radiopharmaceuticals (e.g., radioactive drugs used for therapy or imaging). The present disclosure further relates to systems and methods for the packaging, dispensing, storage, administration, and / or disposal of therapeutic or diagnostic agents that require accurate volumetric delivery from a controlled source.

Background Art

[0003] Radiopharmaceuticals can be utilized for targeted radionuclide therapy (TRT) or diagnostic imaging. Radiopharmaceuticals generally include a radioisotope (e.g., Ac - 255, Lu - 177, etc.), a targeting moiety or biovector (e.g., an antibody, a peptide, an antigen, a small molecule, etc.), and optionally a chelating agent (e.g., DOTA, NOTA, DTPA, etc.) that are bound to each other into a single structure. In some cases, when the radioisotope is one that the human body naturally takes up in tissues or organs, TRT can consist of only the radioisotope without a biovector or chelating agent. Radiopharmaceuticals are configured to interact with target proteins on cells such as cancer cells. Radiopharmaceuticals can be mixed in liquid or fluid form. In some examples or embodiments, the radiopharmaceutical may be solid microparticles accompanied by a fluid (e.g., a slurry suitable for injection into a patient). Administration is generally by intravenous administration into the systemic circulation.

[0004] Examples of TRT may include targeted alpha therapies (TAT) or targeted beta therapies (TBT). Such therapies may be administered as monotherapy or in combination, for example, by simultaneous or sequential administration. Radioactive therapeutic agents for TAT primarily emit alpha rays. The remainder of the radiation emitted from radioactive therapeutic agents for TAT may include gamma rays and / or beta rays. Radioactive therapeutic agents for TBT primarily emit beta rays. The remainder of the radiation emitted for radioactive therapeutic agents for TBT may include gamma rays and / or alpha rays. Examples of targeted alpha therapies, but not limited to, include therapies based on thorium (Th-227), actinium (Ac-225), and lead (Pb-212). Examples of targeted beta-ray therapy include therapies based on lutetium (Lu-177), copper (Cu-67), or iodine (I-131). Other examples of radiotherapeutic agents include alpha-ray therapy agents utilizing radium (Ra) (e.g., the Ra-223 isotope, such as the XOFIGO® therapy offered by Bayer Health Care). The preparation of XOFIGO®, the prepared solution, and the method for use are described in Patent Document 1, the disclosure of which is incorporated herein by reference in its entirety.

[0005] The radiopharmaceuticals used in TRT (Transcranial Remedies) can present significant challenges in their manufacture, storage, distribution, administration, handling, and disposal. Because the therapeutic agents are radioactive, they can cause radiation exposure to human health. Furthermore, considering the decay rate of radiopharmaceuticals, the longer the time elapsed between the manufacture, processing, and delivery to the patient, the less radioactivity will be present in the administered dose. Significant regulations must be followed to safely store and continue to utilize radioactive materials, which can affect how therapeutic agents can be stored and transported, as well as who can use or administer them. For example, such regulations may require care providers to undergo hundreds of hours of training before they can administer any TRT.

[0006] Figure 1 shows a conventional supply chain for TRT. First, the radiopharmaceutical is manufactured in bulk at a manufacturing facility and loaded into bulk containers. The contents of such containers are delivered to a nuclear pharmacy, where a nuclear pharmacist draws a dose based on the prescription work for a specific patient and places it, for example, into a syringe. The patient-ready dose is verified in a dose calibrator at the nuclear pharmacy to validate the prescribed dosing and assay. The dose is calibrated at the time of infusion to ensure that the dose has the necessary activity at the time of infusion. The verified dose is then transported to the treatment site, where it is verified again in a dose calibrator. At the treatment site, the dose must usually be used within a certain time from the time of draw before the dose becomes unsuitable for patient use due to the half-life of the radioactive material. After administration, the used syringe is checked again in a dose calibrator to verify that the correct prescribed dose was administered to the patient.

[0007] As shown in Figure 2, the methods for diagnosing, referring, and treating the patient require multiple methods and many different medical professionals. After patient P is diagnosed by physician D, physician D prescribes a dose of radiopharmaceutical based on a medication plan. The dose is filled by a nuclear pharmacist NP at a nuclear pharmacy before being delivered to an authorized user AU to verify the dose, administer the dose, and verify that the correct dose was delivered to the patient.

[0008] Conventional methods for the distribution and administration of TRT and other therapeutic or diagnostic agents that require precise volume delivery from a controlled source significantly limit their application and use. After considering transport, handling, and patient scheduling, there is limited time at the treatment site to administer the dose to a particular patient. The challenges imposed by fluctuations in transport, handling, and patient scheduling can affect the effectiveness of TRT or other therapeutic or diagnostic agents, including underdosing at the time of drug delivery to the patient. Due to these challenges associated with conventional systems and methods for the distribution and administration of TRT and other therapeutic or diagnostic agents that require precise volume delivery from a controlled source, improved systems and methods for the distribution, handling, administration, and disposal of such therapeutic agents are needed in the art. [Prior art documents] [Patent Documents]

[0009] [Patent Document 1] U.S. Patent No. 6,635,234 [Patent Document 2] U.S. Patent Application Publication No. 2021 / 0187186 [Overview of the project] [Problems that the invention aims to solve]

[0010] Considering the shortcomings of conventional systems and methods for the distribution, handling, administration, and disposal of TRT and other therapeutic or diagnostic agents, better supply chain methods are needed so that treatment sites can have readily available TRT that is accessible for longer periods. Furthermore, improved systems and methods are needed to ensure that stored products are no longer patient-specific. Instead, treatment sites can provide equipment to help administer treatment to any patient who may be present at the site on any given day, resulting in greater flexibility in how stored products can be utilized so that effective doses of radiopharmaceuticals can be delivered to patients. Such patient-specific dosing can be achieved without the need for dose calibrators at the treatment site, thereby reducing or eliminating the need for manual measurement and handling in a designated hot lab. Dosage, volume, and concentration can be accurately measured at the manufacturing or filling site, where it is far more efficient to use dosing and filling equipment such as multiple dose calibrators with error detection and correction, automated sample processing, automated data recording, and accurate weighing or volume determination. More accurate equipment and reduced or eliminated potential for human error enhance the reliability of the entire supply chain. [Means for solving the problem]

[0011] In some embodiments or aspects of the present disclosure, a storage device is provided configured to be connected to a delivery system for delivering therapeutic or diagnostic agents. The storage device may include a housing in which a chamber is defined, and a container placed within the chamber. The container may have a distal end opposite a proximal end, defined between them, and having an interior configured to receive the therapeutic or diagnostic agent. The proximal end of the container may have an access port for accessing the interior. The storage device may further have a door associated with the housing, which is movable relative to the housing between a closed position and an open position. In the closed position, the door may cover the opening of the housing to seal the chamber of the housing. In the open position, the door may expose the opening of the housing for access to the access port of the container. The storage device may further have a holder in the chamber of the housing that contacts the container to secure the container relative to the housing so that the access port of the container is located at the opening of the housing. The door may be movable between the closed position and an open position in response to operation by the access mechanism of the delivery system.

[0012] In some embodiments or aspects of the present disclosure, the holder may include a contact element for contacting the distal end of a container, and a plurality of tabs connected to the contact element and configured to engage with the inner surface of the housing to secure the distal end of the container against the housing. The storage device may further include a plurality of ribs located within the chamber of the housing and surrounding the opening. The plurality of ribs may be configured to secure the proximal end of the container against the housing.

[0013] In some embodiments or aspects of the present disclosure, the storage device may further include a lock for fixing the door in either an open or closed position. The door cover may be connected to the housing and the door cover surrounds the door within the door chamber. The door cover may include a door access opening with a seal and a container access opening, such as via a spike, positioned opposite the opening in the housing. The seal may be perforated by an access mechanism of the delivery system.

[0014] In some embodiments or aspects of the present disclosure, the storage device may further include on the housing a label or tag or data carrier containing machine-readable verifiable data, including at least one of product information, manufacturing information, prescription information, and transport conditions information. The opening of the housing may be configured to receive a spike extending into the access port to access the therapeutic or diagnostic agent when the door is in the open position. In some embodiments or aspects, the therapeutic or diagnostic agent may be a radiopharmaceutical, and the housing includes a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0015] In some embodiments or aspects of the present disclosure, assemblies are provided that are configured to connect to a delivery system for delivering therapeutic or diagnostic agents. The assembly may include a storage device for containing the therapeutic or diagnostic agent, and a fluid cassette that can be fluidly connected to the storage device for accessing the therapeutic or diagnostic agent. The storage device may include a housing in which a chamber is defined, and a container placed within the chamber. The container may have an interior configured to receive the therapeutic or diagnostic agent, and an access port for accessing the interior. The storage device may further include a door associated with the housing, which is movable relative to the housing between a closed position and an open position. In the closed position, the door may cover the opening of the housing to seal the chamber of the housing. In the open position, the door may expose the opening of the housing for access to the access port of the container. The fluid cassette may include a spike, a metering device, and a fluid path set for fluidly connecting the spike to the metering device. The fluid cassette may further include a housing enclosing the spike, the metering device, and the fluid path set. The storage device and fluid cassette may be configured to connect to the delivery system such that the door of the storage device is accessible by the access mechanism of the delivery system, and the spikes and metering device of the fluid cassette are accessible by the delivery mechanism of the delivery system.

[0016] In some embodiments or aspects of the present disclosure, the spike of the fluid cassette may be insertable into the access port of the container when the door is moved to the open position to fluidly connect the metering device to the container via a fluid path set. The fluid path set may include one or more valves that are operable by the delivery mechanism of the delivery system to regulate the flow of fluid through the fluid path elements. The fluid cassette may be connectable to a saline supply source.

[0017] In some embodiments or aspects of this disclosure, the storage device may include a guide mechanism configured to position the storage device in a desired orientation relative to the fluid cassette. The guide mechanism may include one or more geometric features on the storage device. One or more geometric features may be configured to couple with one or more corresponding geometric features on the fluid cassette. One or more geometric features may prevent coupling between incompatible system components.

[0018] In some embodiments or aspects of the present disclosure, the outlet of the fluid cassette metering device may be configured to connect to an infusion set to deliver a dose of therapeutic or diagnostic agent from the container to the infusion set. The storage device may further include a label or tag on the housing containing machine-readable verifiable data, including at least one of product information, manufacturing information, prescription information, and transport conditions information. The therapeutic or diagnostic agent may be a radiopharmaceutical, and the housing includes a shield configured to prevent significant radiation from the radiopharmaceutical from being emitted from the housing.

[0019] In some embodiments or aspects of the present disclosure, a delivery system for delivering a therapeutic or diagnostic agent is provided. The delivery system may include an injector having a delivery mechanism and an access mechanism, and a fluid delivery assembly that is removably connectable to the injector. The fluid delivery assembly may include a storage device for containing the therapeutic or diagnostic agent, and a fluid cassette that is fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent. The storage device may include a housing in which a chamber is defined, and a container disposed within the chamber. The container may have an interior configured to receive the therapeutic or diagnostic agent, and an access port for accessing the interior. The storage device may further include a door associated with the housing, the door being movable between a closed position and an open position relative to the housing via the access mechanism of the injector. In the closed position, the door may cover the opening of the housing to seal the chamber of the housing. In the open position, the door may expose the opening of the housing for access to the access port of the container. The fluid cassette may include a spike, a metering device, and a fluid path set for fluidly connecting the spike to the metering device. The fluid cassette may further include a housing enclosing a spike, a metering device, and a fluid path set. The spike and metering device of the fluid cassette may be accessible by an injector delivery mechanism to fluidize the inside of the container through the fluid path set to the metering device.

[0020] In some embodiments or aspects of the present disclosure, the delivery system further includes an injector controller configured to determine the dose of a therapeutic or diagnostic agent to be drawn from a container into a dispensing device based on machine-readable authentication data on a storage device. The injector controller may further be configured to determine the dose of a therapeutic or diagnostic agent to be drawn from a container into a dispensing device based on at least one patient parameter. The injector controller may be connected to a hospital network system, a hospital enterprise system, or other healthcare network. The injector controller may include a plurality of dosing algorithms for various predetermined therapeutic or diagnostic procedures.

[0021] In some embodiments or aspects of the present disclosure, the fluid path set may include one or more valves that are operable by a delivery mechanism of a delivery system to regulate the flow of fluid through the fluid path elements. The fluid cassette may be connectable to a saline supply source or other washing fluid supply source. The outlet of the metering device of the fluid cassette may be configured to connect to an infusion set to deliver a dose of therapeutic or diagnostic agent from a container to the infusion set. The storage device may be configured to be connectable to the fluid cassette, either detachably or permanently.

[0022] In some embodiments or aspects of the present disclosure, a stocking device is provided for managing the storage and disposal of used therapeutic or diagnostic agents. The stocking device may include a cart having a storage compartment accessible via a lockable door. The storage compartment may be configured to store one or more waste containers. Each waste container may include a storage device having a housing in which a chamber is defined, and a container placed within the chamber of the housing. The container may be configured to store a radiopharmaceutical inside. The door may be connected to the housing and movable between an open position and a closed position. In the closed position, the door may completely seal the chamber of the housing. The device may further include a fluid cassette having a spike and a metering device. The storage device may be fixed to the fluid cassette such that the spike is inserted into the container and the metering device is fluidly connected to the container. The metering device may be connected to an infusion set used to inject a dose of the radiopharmaceutical. The infusion set, storage device, and fluid cassette may be held in a waste container.

[0023] In some embodiments or aspects of the present disclosure, the cart may include at least one indicator associated with a storage compartment to indicate whether any of one or more waste containers have been stored for a preselected storage period such that the radioactive components of the used therapeutic or diagnostic agent decay to a preselected safe threshold level. The cart may include wheels having a wheel lock configured to prevent unauthorized or unintended movement of the cart. The wheel lock may be an electronic lock that communicates with a controller. The wheel lock may be a mechanical lock having a key or other mechanical locking mechanism. The wheel lock may be operably connected to a fixable door such that the wheels are unlocked and rollable only after the fixable door is unlocked.

[0024] In some embodiments or aspects of the present disclosure, a method for the manufacture and distribution of a therapeutic or diagnostic agent is provided. The method may include filling a container with a therapeutic or diagnostic agent, placing the container within a chamber of a storage device having a housing, closing the storage device such that the housing completely surrounds the container within the chamber, transporting the storage device to an administration facility, opening the door of the storage device using an access mechanism of a delivery system, disinfecting an access port of the container using a disinfection mechanism of the delivery system, and accessing the therapeutic or diagnostic agent within the container via the access port using the delivery system.

[0025] In some embodiments or aspects of the present disclosure, accessing the therapeutic or diagnostic agent may include piercing the access port using a spike of a cassette connected to the storage device. The method may further include reading a label or tag on the storage device to determine at least one of product information, manufacturing information, prescription information, and transport condition information. The method may further include disinfecting the access port by emitting ultraviolet light or emitting a disinfection material.

[0026] In some embodiments or aspects of the present disclosure, a method for storing and disposing of used therapeutic or diagnostic agents is provided. The method may include the step of collecting a storage device that holds a container having a remaining portion of the therapeutic or diagnostic agent, a cassette to which the storage device is fluidly connected, and an infusion set for placement within a disposal container. The method may further include the step of placing a label, tag, or other indicator on the disposal container to indicate the date of use, the step of placing the disposal container having the storage device, cassette, and infusion set therein within a storage compartment, and the step of indicating that the disposal container is safe to discard after a preselected decay period has elapsed. The method may further include the step of reading a label or other indicator to determine at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0027] In some embodiments or aspects of the present disclosure, a method for delivering a dose of a therapeutic or diagnostic agent is provided. The method may include the step of introducing the therapeutic or diagnostic agent into a container, the step of placing the container within a chamber of a storage device having a housing, the step of closing a door of the storage device such that the housing completely surrounds the container within the chamber to shield radiation emitted by a radiopharmaceutical from being emitted from the housing for transport and storage of the radiopharmaceutical, the step of determining a dose of the radiopharmaceutical for a patient based on manufacturing information of the radiopharmaceutical included in the storage device, and the step of unlocking the door of the storage device to open the housing to access the radiopharmaceutical within the container and inject the determined dose into the patient.

[0028] In some embodiments or aspects of the present disclosure, the step of accessing a therapeutic or diagnostic agent may include puncturing an access port of a container using a spike on a cassette connected to a storage device. The method may further include reading a label or tag on the storage device to determine at least one of product information, manufacturing information, prescription information, and transport conditions information. The method may further include disinfecting the access port of the container. The step of disinfecting the access port may include emitting ultraviolet light or ejecting a disinfectant material.

[0029] Additional embodiments or aspects of the systems and methods described herein are detailed in one or more of the following sections.

[0030] Clause 1: A storage device configured to be connected to a delivery system for delivering therapeutic or diagnostic agents, the storage device comprising: a housing having a chamber defined inside; a container disposed within the chamber, configured to receive therapeutic or diagnostic agents, having a distal end opposite a proximal end, with an interior defined between them, and the proximal end having an access port for accessing the interior; a door associated with the housing, movable relative to the housing between a closed position and an open position, in the closed position covering the opening of the housing to seal the chamber of the housing, and in the open position exposing the opening of the housing to access the access port of the container; a holder in contact with the container within the chamber of the housing to secure the container relative to the housing such that the access port of the container is located at the opening of the housing, wherein the door is movable between a closed position and an open position in response to operation by an access mechanism of the delivery system.

[0031] Clause 2: The storage device according to Clause 1, comprising a holder, a contact element for contacting the distal end of a container, and a plurality of tabs connected to the contact element and configured to engage with the inner surface of the housing to secure the distal end of the container against the housing.

[0032] Clause 3: The storage apparatus according to Clause 1 or 2, further comprising a plurality of ribs within the chamber of the housing, the plurality of ribs surrounding the opening, the plurality of ribs configured to secure the proximal end of the container to the housing.

[0033] Clause 4: The storage device according to any one of Clauses 1 to 3, further comprising a lock for fixing the door in either the open or closed position.

[0034] Clause 5: A storage device according to any one of Clauses 1 to 4, further comprising a door cover connected to the housing, the door cover enclosing the door within the door chamber.

[0035] Clause 6: The storage device according to any one of Clauses 1 to 5, comprising a door cover comprising a door access opening having a seal and a container access opening positioned opposite the opening of the housing.

[0036] Clause 7: The storage apparatus described in Clause 6, wherein the seal is perforated by the access mechanism of the delivery system.

[0037] Clause 8: The storage device according to any one of Clauses 1 to 7, further comprising on the housing a label or tag containing machine-readable certifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.

[0038] Clause 9: A storage device according to any one of Clauses 1 to 8, wherein the opening of the housing is configured to receive a spike extending into an access port for accessing a therapeutic or diagnostic agent when the door is in the open position.

[0039] Clause 10: The storage apparatus according to any one of Clauses 1 to 9, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0040] Clause 11: An assembly configured to connect to a delivery system for delivering a therapeutic or diagnostic agent, the assembly comprising: a storage device for containing the therapeutic or diagnostic agent; and a fluid cassette that can be fluidly connected to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing in which a chamber is defined; a container disposed within the chamber, having an interior configured to receive the therapeutic or diagnostic agent; and an access port for accessing the interior; and a door associated with the housing, movable relative to the housing between a closed position and an open position, in the closed position covering the opening of the housing to seal the chamber of the housing; and in the open position exposing the opening of the housing for accessing the access port of the container, the fluid cassette comprising: a spike; a metering device; and a fluid path set for fluidly connecting the spike to the metering device; and a housing surrounding the spike; the storage device and the fluid cassette are configured to connect to a delivery system such that the door of the storage device is accessible by the access mechanism of the delivery system, and the metering device of the spike and the fluid cassette are accessible by the delivery mechanism of the delivery system.

[0041] Clause 12: The assembly as described in Clause 11, wherein the container access member of the fluid cassette is insertable into the access port of the container when the door is moved to the open position to fluidly connect the metering device to the container via the fluid path set.

[0042] Clause 13: The assembly described in Clause 11 or 12, comprising one or more valves that are operable by a delivery mechanism of a delivery system to regulate the flow of fluid through the fluid path elements.

[0043] Clause 14: The fluid cassette is connectable to a saline supply source, as per any one of the assemblies described in Clauses 11 to 13.

[0044] Clause 15: The storage device is an assembly according to any one of Clauses 11 to 14, comprising a guide mechanism configured to position the storage device in a desired orientation relative to the fluid cassette.

[0045] Clause 16: The assembly according to Clause 15, wherein the guide mechanism comprises one or more geometric features on the storage device, and the one or more geometric features are configured to be coupled with one or more corresponding geometric features on the fluid cassette.

[0046] Clause 17: The assembly described in any one of Clauses 11 to 16, wherein the outlet of the metering device of the fluid cassette is configured to connect to an infusion set for delivering a dose of therapeutic or diagnostic agent from a container to the infusion set.

[0047] Clause 18: The assembly described in any one of Clauses 11 to 17, further comprising on the housing a label or tag containing machine-readable certifiable data including at least one of product information, manufacturing information, prescription information, and shipping conditions information.

[0048] Clause 19: The therapeutic or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing, as described in any one of Clauses 11 to 18.

[0049] Clause 20: A delivery system for delivering therapeutic or diagnostic agents, the delivery system comprising: an injector having a delivery mechanism and an access mechanism; a fluid delivery assembly removablely connectable to the injector, comprising a storage device for containing therapeutic or diagnostic agents, and a fluid cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agents, wherein the storage device comprises: a housing having a chamber defined therein; a container disposed within the chamber, having an interior configured to receive therapeutic or diagnostic agents, and an access port for accessing the interior; and a door associated with the housing, of the injector A delivery system comprising: a door that is movable between a closed position and an open position relative to the housing via an access mechanism, covering the opening of the housing to seal the chamber of the housing in the closed position, and exposing the opening of the housing to access the access port of the container in the open position; a fluid cassette comprising: a container access member, a metering device, and a fluid path set for fluidly connecting the container access member to the metering device; and a housing surrounding the container access member, the metering device, and the fluid path set, wherein the container access member and the metering device of the fluid cassette are accessible by an injector delivery mechanism for fluidly connecting the inside of the container to the metering device via the fluid path set.

[0050] Clause 21: The delivery system according to Clause 20, further comprising an injector controller configured to determine the dose of a therapeutic or diagnostic agent to be drawn from a container into a weighing device based on machine-readable authentication data on a storage device.

[0051] Clause 22: The delivery system as described in Clause 21, further configured to determine the dose of a therapeutic or diagnostic agent to be drawn from a container into a dispensing device based on at least one patient parameter.

[0052] Clause 23: The injector controller is connected to the hospital network system, the delivery system as described in Clause 21 or 22.

[0053] Clause 24: The injector controller is a delivery system as described in any one of Clauses 21 to 23, comprising multiple drug delivery algorithms for various predetermined therapeutic or diagnostic procedures.

[0054] Clause 25: A fluid path set comprising one or more valves that can be operated by a delivery mechanism of the delivery system to regulate the flow of fluid through the fluid path elements, as described in any one of Clauses 20 to 24.

[0055] Clause 26: A fluid cassette is connectable to a saline supply source, as described in any one of Clauses 20 to 25 of the delivery system.

[0056] Clause 27: A delivery system according to any one of Clauses 20 to 26, wherein the outlet of the metering device of the fluid cassette is configured to connect to an infusion set for delivering a dose of therapeutic or diagnostic agent from a container to the infusion set.

[0057] Clause 28: The storage device is configured to be removably or non-removably connected to the fluid cassette, as described in any one of Clauses 20 to 27.

[0058] Clause 29: The delivery system according to any one of Clauses 20 to 28, further comprising on the housing a label or tag containing machine-readable certifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.

[0059] Clause 30: A delivery system according to any one of Clauses 20 to 29, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0060] Clause 31: A stocking device for managing the storage and disposal of used therapeutic or diagnostic agents, the stocking device comprising a cart having a storage compartment, which is accessible via a fixed door and configured to store one or more waste containers, each of which is a storage device comprising a housing in which a chamber is defined, a container placed within the chamber of the housing and configured to store a radiopharmaceutical inside, and a door connected to the housing, which is movable between an open position and a closed position and, in the closed position, completely seals the chamber of the housing; and a fluid cassette comprising a container access member and a metering device, the storage device comprising a fluid cassette in which the container access member is inserted into the container and fixed to the fluid cassette so as to fluidly connect the metering device to the container, the metering device being connected to an infusion set used for infusioning doses of radiopharmaceuticals, the stocking device comprising an infusion set, the storage device and the fluid cassette being held in a waste container.

[0061] Clause 32: The inventory apparatus as described in Clause 31, comprising at least one indicator associated with a storage compartment to indicate whether one or more waste containers have been stored for a predetermined storage period so that the radioactive components of used therapeutic or diagnostic agents decay to a predetermined safety threshold level.

[0062] Clause 33: The inventory device as described in Clause 31 or 32, the cart having wheels with wheel locks configured to prevent unauthorized movement of the cart.

[0063] Clause 34: The wheel lock is an electronic lock that communicates with the controller, as described in Clause 33.

[0064] Clause 35: A wheel lock is a mechanical lock having a key or other mechanical locking mechanism, as described in Clause 33 or 34 of the stocking device.

[0065] Clause 36: A storage device as described in any one of Clauses 33 to 35, wherein the wheel lock is operably connected to a lockable door such that the wheels are unlocked and rollable only after the lockable door has been unlocked.

[0066] Clause 37: A method for manufacturing and distributing therapeutic or diagnostic agents, comprising the steps of: filling a container with a therapeutic or diagnostic agent; placing the container in a chamber of a storage device having a housing; closing the storage device such that the housing completely encloses the container within the chamber; transporting the storage device to a control facility; opening the door of the storage device using an access mechanism of a delivery system; disinfecting the access port of the container using a disinfection mechanism of a delivery system; and accessing the therapeutic or diagnostic agent in the container through the access port using a delivery system.

[0067] Clause 38: The method according to Clause 37, wherein the step of accessing a therapeutic or diagnostic agent includes puncturing an access port using a container access member of a cassette connected to a storage device.

[0068] Clause 39: The method according to Clause 37 or 38, further comprising the step of reading a label or tag on a storage device to determine at least one of product information, manufacturing information, prescription information, and transport conditions information.

[0069] Clause 40: The method according to any one of Clauses 37 to 39, wherein the step of disinfecting the access port includes emitting ultraviolet light or injecting a disinfectant material.

[0070] Clause 41: A method for storing and disposing of used therapeutic or diagnostic agents, comprising the steps of: a storage device for holding a container containing the remaining portion of the therapeutic or diagnostic agent; a cassette to which the storage device is fluidly connected; and an infusion set for placement in a waste container; placing a label, tag or other indicator on the waste container to indicate the date of use; placing a waste container having the storage device, cassette and infusion set inside within a storage area; and indicating that the waste container is safe after a predetermined decay period has elapsed.

[0071] Clause 42: The method according to Clause 41, further comprising the step of reading a label, tag or other indicator to determine at least one of product information, manufacturing information, prescription information and transport conditions information.

[0072] Clause 43: A method for delivering a dose of a therapeutic or diagnostic agent, comprising: inserting the therapeutic or diagnostic agent into a container; placing the container in a chamber of a storage device having a housing; closing the door of the storage device so that the housing completely encloses the container within the chamber in order to shield radiation emitted by the radiopharmaceutical from being emitted from the housing for transport and storage of the radiopharmaceutical; determining a dose of the radiopharmaceutical to a patient based on manufacturing information of the radiopharmaceutical contained in the storage device; and unlocking the door of the storage device to open the housing, access the radiopharmaceutical in the container, and inject the determined dose into the patient.

[0073] Clause 44: The method of Clause 43, wherein access to a therapeutic or diagnostic agent includes puncturing an access port using a container access member of a cassette connected to a storage device.

[0074] Clause 45: The method according to Clause 43 or 44, further comprising the step of reading a label or tag on a storage device to determine at least one of product information, manufacturing information, prescription information and transport conditions information.

[0075] Clause 46: The method according to any one of Clauses 43 to 45, further comprising the step of disinfecting the access port of the container.

[0076] Clause 47: The method according to Clause 46, wherein the step of disinfecting the access port includes emitting ultraviolet light or injecting a disinfectant material.

[0077] Clause 48: A storage device configured to connect to a delivery system, the storage device comprising: a housing in which a chamber is defined; a container disposed within the chamber and containing a radiopharmaceutical therein, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of free metal cations of the alkaline earth metal radium-223; a door associated with the housing, movable relative to the housing between a closed position and an open position, in the closed position covering the opening of the housing to seal the chamber of the housing, and in the open position exposing the opening of the housing to access an access port of the container; and a holder in contact with the container within the chamber of the housing to secure the container relative to the housing such that the access port of the container is located at the opening of the housing, wherein the door is movable between a closed position and an open position in response to operation by an access mechanism of the delivery system.

[0078] Clause 49: An assembly configured to connect to a delivery system for delivering a radiopharmaceutical, the assembly comprising: a storage device for containing a therapeutic or diagnostic agent; and a fluid cassette that can be fluidly connected to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing in which a chamber is defined; a container disposed within the chamber and containing a radiopharmaceutical, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of free metal cations of the alkaline earth metal radium-223; and a door associated with the housing, movable relative to the housing between a closed position and an open position, in the closed position, the housing An assembly comprising: a door that covers the opening of the housing to seal a chamber, and in the open position exposes the opening of the housing for access to the container access port; a fluid cassette comprising: a container access member, a measuring device, and a fluid path set for fluidly connecting the container access member to the measuring device; and a housing surrounding the container access member, the measuring device, and the fluid path set; the storage device and the fluid cassette are configured to connect to a delivery system such that the door of the storage device is accessible by the access mechanism of the delivery system, and the measuring device of the container access member and the fluid cassette are accessible by the delivery mechanism of the delivery system.

[0079] Clause 50: A delivery system for delivering a therapeutic or diagnostic agent, the delivery system comprising: an injector having a delivery mechanism and an access mechanism; a fluid delivery assembly removablely connectable to the injector, comprising a storage device for containing the therapeutic or diagnostic agent; and a fluid cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing having a chamber defined therein; a container disposed within the chamber of the housing and containing a radiopharmaceutical therein, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of free metal cations of the alkaline earth metal radium-223; and a door associated with the housing, movable between a closed position and an open position relative to the housing via the access mechanism of the injector, in the closed position covering the opening of the housing to seal the chamber of the housing, and in the open position covering the access of the container A fluid cassette comprising a door that exposes an opening in the housing for accessing a cessport, the fluid cassette comprising a container access member, a metering device, and a fluid path set for fluidly connecting the container access member to the metering device, and a housing surrounding the container access member, the metering device, and the fluid path set, wherein the container access member and the metering device of the fluid cassette are accessible by a delivery mechanism of an injector to fluidly connect the inside of the container to the metering device via the fluid path set, the injector comprising an injector controller configured to determine the dose of a radiopharmaceutical based on manufacturing data mounted on the housing of the storage device, the injector controller being communicably connected to the injector to control the injector to inject the dose such that the injectable dose to be received by the patient is the dose determined by the injector controller based on manufacturing data mounted on the housing of the storage device, and a delivery system.

[0080] Clause 51: A storage device for managing the storage and disposal of spent radiopharmaceuticals, the storage device comprising a cart having shelves configured to store disposal containers, each of which is a storage device comprising a housing having a chamber defined therein, a container placed within the chamber of the housing configured to store radiopharmaceuticals therein, and a door connected to the housing, movable between an open position and a closed position, and in the closed position completely sealing the chamber of the housing, the storage device comprising a container access member A fluid cassette comprising a weighing device, wherein the storage device is fixed to the fluid cassette so as to be inserted into the container and to fluidly connect the weighing device to the container, and the weighing device is connected to an infusion set used for infusioning doses of a radiopharmaceutical, wherein the infusion set, the storage device and the fluid cassette are held in a waste container, and the cart is equipped with indicators for shelves to indicate which waste container has been stored for a predetermined storage period so as to the radiopharmaceutical so as to fall below a predetermined safety threshold level.

[0081] Clause 52: A method for the manufacture and distribution of a radiopharmaceutical for targeted isotope therapy or imaging services, comprising the steps of: filling a container with a radiopharmaceutical for TRT or imaging services, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of free metal cations of the alkaline earth metal radium-223; placing the container in a chamber of a storage device having a housing; closing the storage device such that the housing completely encloses the container within the chamber; transporting the storage device to a control facility; opening the door of the storage device using an access mechanism of a delivery system; disinfecting the access port of the container using a disinfection mechanism of a delivery system; and accessing the radiopharmaceutical in the container through the access port using a delivery system.

[0082] Clause 53: A method for storing and disposing of a radiopharmaceutical used in targeted isotope therapy or imaging services, comprising the steps of: retrieving a storage device for holding a container having a residual portion of the radiopharmaceutical; a cassette to which the storage device is connected; and an infusion set for placement in a waste container; placing a label, tag or other indicator on the waste container to indicate the date of use; placing a waste container having the storage device, cassette and infusion set inside within a storage area; and indicating that the waste container will be safely disposed of after a predetermined decay period has elapsed, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of free metal cations of the alkaline earth metal radium-223.

[0083] Clause 54: A method for administering a dose of a targeted isotope therapy or imaging service, comprising the steps of: inserting a radiopharmaceutical into a container, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of free metal cations of the alkaline earth metal radium-223; placing the container in a chamber of a storage device having a housing; closing the door of the storage device such that the housing completely encloses the container within the chamber to shield radiation emitted by the radiopharmaceutical from being emitted from the housing for transport and storage of the radiopharmaceutical; determining a dose of the radiopharmaceutical to a patient based on manufacturing information of the radiopharmaceutical contained in the storage device; and unlocking the door of the storage device to open the housing, access the radiopharmaceutical in the container, and administer the determined dose to the patient.

[0084] Clause 55: A radiopharmaceutical injection system for therapeutically or prophylactically effective amounts of free metal cations of radium-223, as described in any one of Clauses 1 to 54.

[0085] Clause 56: Stockpile equipment for the control, storage, and disposal of therapeutically or prophylactically effective amounts of free metal cations of radium-223, as described in any one of Clauses 1 to 55.

[0086] Clause 57: A method further comprising a therapeutically or prophylactically effective amount of free metal cations of radium-223, as described in any one of Clauses 1 to 56. [Brief explanation of the drawing]

[0087] [Figure 1] This is a typical schematic diagram of a conventional supply chain for radiotherapeutic agents configured for use in conjunction with prior art TRT. [Figure 2] This is a typical schematic diagram of a conventional method for administering TRT using prior art. [Figure 3] This is a representative schematic diagram of an improved supply chain for radiotherapeutic agents configured for use with TRT, according to some embodiments or aspects of the present disclosure. [Figure 4] This is a representative schematic diagram of an improved method for TRT administration according to some embodiments or aspects of the present disclosure. [Figure 5] This is a perspective view of a system for dispensing, administering, and disposing of liquid products requiring precise volume delivery from a controlled source, according to some embodiments or aspects of the present disclosure. [Figure 6] This is a perspective view of a system for dispensing, administering, and disposing of liquid products requiring precise volume delivery from a controlled source, according to some embodiments or aspects of the present disclosure. [Figure 7] This is a perspective view of a storage apparatus for storing liquid products such as radiotherapeutic agents, according to some embodiments or aspects of the present disclosure. [Figure 8] Figure 7 is a cross-sectional perspective view of the storage device shown. [Figure 9] Figure 7 is an exploded perspective view of the storage device shown. [Figure 10] This is a cross-sectional perspective view of the storage device shown together with the first container. [Figure 11] This is a cross-sectional perspective view of the storage device shown together with the second container. [Figure 12]This is a detailed perspective view of a security cover on the access door of a storage device according to some embodiments or aspects of the present disclosure. [Figure 13] This is a detailed diagram of a locking mechanism for preventing reuse of a storage device, according to some embodiments or aspects of the present disclosure. [Figure 14] This is a detailed diagram of a locking mechanism for preventing reuse of a storage device, according to some embodiments or aspects of the present disclosure. [Figure 15] This is a perspective view of a storage apparatus for storing liquid products such as radiotherapeutic agents, according to some embodiments or aspects of the present disclosure. [Figure 16] Figure 15 is a side view of the storage device shown. [Figure 17A] The following are bottom perspective views of storage devices according to several embodiments or aspects of the present disclosure. [Figure 17B] The following are bottom perspective views of storage devices according to several embodiments or aspects of the present disclosure. [Figure 18] Figure 15 is an exploded perspective view of the storage device shown. [Figure 19] Figure 15 is a cross-sectional perspective view of the storage device shown. [Figure 20] This is a perspective view of a storage device and a fluid cassette for dispensing a dose from the storage device, according to some embodiments or aspects of the present disclosure. [Figure 21] Figure 20 is a perspective view of the fluid cassette shown. [Figure 22] Figure 21 is an exploded perspective view of the fluid cassette. [Figure 23] This is a perspective view of a container access member configured to perforate a container of a storage device, according to some embodiments or aspects of the present disclosure. [Figure 24] This is a detailed perspective view of a fluid cassette metering device connection interface according to some embodiments or aspects of the present disclosure. [Figure 25A] This is a perspective view of the plunger cap in the unlocked position. [Figure 25B] This is a perspective view of the plunger cap shown in Figure 25A in a fixed position. [Figure 26] This is a perspective view of a fluid cassette and components of a delivery system configured to interact with the fluid cassette, according to some embodiments or aspects of the present disclosure. [Figure 27] This is a perspective view of a storage device and a fluid cassette for dispensing a dose from the storage device, according to some embodiments or aspects of the present disclosure. [Figure 28] Figure 27 is a detailed diagram of the connection between the storage device and the fluid cassette. [Figure 29] Figure 28 is a perspective view of the fluid cassette. [Figure 30] Figure 29 is an exploded perspective view of the fluid cassette. [Figure 31] This is a schematic diagram of a fluid connection between a storage device container, a fluid cassette, and a patient delivery line, according to some embodiments or aspects of the present disclosure. [Figure 32] This is a perspective view of a fluid cassette and storage device, as well as components of an infusion system configured to interact with a fluid cassette and storage device, according to some embodiments or aspects of the present disclosure. [Figure 33] Figure 32 is a perspective view of the components of the infusion system shown. [Figure 34] This is a perspective view of a disinfection system for disinfecting a part of a storage device, according to some embodiments or aspects of the present disclosure. [Figure 35] This is a perspective view of a carrier tray for transporting multiple storage devices according to some embodiments or aspects of the present disclosure. [Figure 36] This is a perspective view of a storage device and a waste container for disposing of cassettes according to some embodiments or aspects of the present disclosure. [Figure 37] This is a schematic diagram of a storage enclosure for storing multiple waste containers according to some embodiments or aspects of the present disclosure. [Figure 38] This is a flowchart of a procedure for checking for openness according to some embodiments or aspects of the present disclosure. [Figure 39]This is a flowchart of an administration procedure using a system described according to some embodiments or aspects of this disclosure. [Modes for carrying out the invention]

[0088] In Figures 1 to 39, similar characters refer to the same constituent elements and components unless otherwise specified.

[0089] As used herein, the singular forms of "a," "an," and "the" refer to multiple objects unless otherwise explicitly indicated by the context.

[0090] Spatial or directional terms such as "left," "right," "inner," "outer," "above," and "below" are related to embodiments or aspects as shown in the drawings and should not be considered limiting, as embodiments or aspects can take on various alternative orientations.

[0091] All figures used herein and in the claims should be understood to be modified in all cases by the term “about,” meaning ±25% of the stated value, for example, ±10% of the stated value. However, this should not be considered to be limited to the analysis of values ​​under the doctrine of equivalents.

[0092] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to include the starting and ending values ​​and any partial ranges or ratios encompassed therein. For example, a range or ratio described as "1 to 10" should be considered to include all partial ranges or ratios between (and including) the minimum value of 1 and the maximum value of 10; that is, all partial ranges or ratios that begin with a minimum value of 1 or greater and end with a maximum value of 10 or less. Ranges and / or ratios disclosed herein represent the mean values ​​over the specified ranges and / or ratios.

[0093] Terms such as "first," "second," etc., do not refer to a specific order or chronological sequence, but rather to various conditions, characteristics, or elements.

[0094] All documents referenced herein are incorporated in their entirety by reference.

[0095] The term "at least" is synonymous with "greater than or equal to."

[0096] The term "not greater than" is synonymous with "less than or equal to."

[0097] Some non-limiting embodiments or aspects may be described herein in relation to thresholds. As used herein, satisfying a threshold can mean values ​​such as greater than the threshold, more than the threshold, higher than the threshold, greater than or equal to the threshold, less than the threshold, less than the threshold, lower than the threshold, less than or equal to the threshold, and equal to the threshold.

[0098] As used herein, "at least one of" is synonymous with "one or more of." For example, the phrase "at least one of A, B, or C" means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, "at least one of A, B, or C" includes A only, or B only, or C only, or A and B, or A and C, or B and C, or A, B, and C all of them.

[0099] The term "includes" is synonymous with "comprises" or "to provide."

[0100] When used in reference to components of a fluid delivery system, such as a fluid reservoir, syringe, or fluid line, the term "distal" refers to the part of the component closest to the patient. When used in reference to components of an injector system, such as a fluid reservoir, syringe, or fluid line, the term "proximal" refers to the part of the component closest to the injector (i.e., the part of the component furthest from the patient). When used in reference to components of a fluid delivery system, such as a fluid reservoir, syringe, or fluid line, the term "upstream" refers to the direction away from the patient and towards the injector, relative to the normal flow of fluid in the injector system. When used in reference to components of a fluid delivery system, such as a fluid reservoir, syringe, or fluid line, the term "downstream" refers to the direction away from the injector and towards the patient, relative to the normal flow of fluid in the fluid delivery system.

[0101] As used herein, the terms “communication” and “communicate” may mean the reception, receipt, transmission, transfer, provision, and / or similar of information (e.g., data, signals, messages, instructions, commands, and / or similar).

[0102] As used herein, the term “radiopharmaceutical” refers to a pharmaceutical product containing a radionuclide. As described herein, radiopharmaceuticals are preferably configured for intravenous (iv) administration. There are two types of radiopharmaceuticals: diagnostic (or imaging) radiopharmaceuticals and therapeutic radiopharmaceuticals, although therapeutic radiopharmaceuticals may be used for both purposes in some cases. For example, a TRS may therefore emit gamma rays that can be used for dosimetry and / or diagnostic purposes. Radiopharmaceuticals commonly used for imaging, such as positron emission, may also be used therapeutically. See, for example, Hioki, T., Gholami, YH, McKelvey, KJ et al., Overlooked potential of positrons in cancer therapy (Sci Rep 11, 2475 (2021)).

[0103] The terms “diagnostic radiopharmaceutical” or “imaging radiopharmaceutical,” as used herein, include gamma-ray emitting imaging radiopharmaceuticals for use in SPECT or SPECT / CT imaging, and / or positron-emitting imaging radiopharmaceuticals for use in PET or PET / CT imaging. Examples of gamma-ray emitting imaging radiopharmaceuticals include, but are not limited to, technetium (Tc-99m), iodine (I-123), indium (In-111), gallium (Ga-67), or rhenium (Re-186). Examples of positron-emitting imaging radiopharmaceuticals include, but are not limited to, fluorine (F-18), gallium (Ga-68), zirconium (Zr-89), iodine (I-124), copper (Cu-64), rubidium (Rb-82), or yttrium (Y-86).

[0104] When used herein, the term "therapeutic radiopharmaceutical" includes beta-ray therapeutic radiopharmaceuticals, alpha-ray therapeutic radiopharmaceuticals, positron-based therapeutic radiopharmaceuticals, Auger-based therapeutic radiopharmaceuticals, gamma-ray therapeutic radiopharmaceuticals, and / or combinations thereof.

[0105] As used herein, the term “therapeutic or diagnostic agent” means any diagnostic, imaging, radiotherapy or chemotherapeutic, therapeutic agent, or any other (reconstituted) liquid or powder used in a therapeutic or diagnostic capacity that requires precise dose delivery from a controlled source, where dose is the amount of active ingredient. Dose delivery may be achieved by precise volume delivery.

[0106] All radiation shielding is fragmentary or partial. Adding a layer half the thickness of the shielding reduces transmitted radiation by half. The effectiveness of shielding depends on the energy of the radiation being shielded. Therefore, terms such as “blocking,” “stopping,” or “preventing” radiation transmission or emission indicate a reduction in transmitted or emitted radiation to an acceptable level. This acceptable level may depend on local regulations, requirements, policies, or preferences. Many of the materials used in shielding and related guidelines are well known to those skilled in the field of health physics.

[0107] This disclosure includes, consists of, or essentially consists of, the following examples of embodiments or aspects in any combination. Various examples of this disclosure may be described separately; however, this should be understood to be merely for the sake of illustration and explanation. In practicing this disclosure, one or more aspects of this disclosure described in one example may be combined with one or more aspects of this disclosure described in one or more of the other examples.

[0108] In various embodiments or aspects, this disclosure relates to systems and methods for the distribution, storage, administration, and disposal of radiopharmaceutical therapeutic agents. This disclosure also relates to systems and methods for the distribution, storage, administration, and disposal of other therapeutic or diagnostic agents, such as chemotherapeutic drugs, that require precise volume delivery from a controlled source. As described herein, conventional methods for the distribution and administration of therapeutic or diagnostic agents that require precise volume delivery from a controlled source significantly limit their applicability and use. After considering transportation, handling, and patient scheduling, the treatment site has limited time to administer doses to specific patients. The systems and methods described herein bring about improvements in the distribution, storage, administration, and disposal of therapeutic or diagnostic agents to enable longer time to administer doses to specific patients.

[0109] As described in various embodiments or aspects of this disclosure, a storage device may be configured to store radiotherapeutic agents from the manufacturing site for transport and storage at a treatment facility, such that the radiotherapeutic agents are stored in a completely sealed state until they are used. Each storage device may be sized, shaped and configured to provide adequate radiation shielding for the radioisotopes and doses being stored. The storage devices may be further packaged and enclosed by additional shielding. The housing of the storage device may be configured to be opened and unpacked only at the treatment site using a dedicated device, as described herein. In some embodiments or aspects, the storage device may be configured to store therapeutic or diagnostic agents other than radiotherapeutic agents from the manufacturing site for transport and storage at a treatment facility, such that the therapeutic or diagnostic agents are stored in a completely sealed state until they are used.

[0110] As described in various embodiments or aspects of this disclosure, the system may be provided to include a radiotherapeutic injection / infusion system specifically adapted to access a therapeutic or diagnostic agent stored in a storage device, such that the material is accessible only for administration to a patient via the infusion / infusion system, otherwise administration would be prevented if the storage device is not recognized as an untampered storage device. The storage device may be configured so that only the injection / infusion system can open the storage device and access the therapeutic or diagnostic agent for injection to a patient. If the therapeutic or diagnostic agent is a radiopharmaceutical, the combination of the storage device and the injection / infusion system may help ensure that the radioactive material remains completely sealed and stored from manufacture to use. Furthermore, to facilitate the safe containment and disposal of radioactive waste after use, the infusion / infusion system and storage device, once used, may remain connected and inoperable.

[0111] As described in various embodiments or aspects of this disclosure, a system and method can be provided for determining an appropriate dose for a patient to be injected into the patient, based on patient parameters such as the therapeutic or diagnostic agent to be administered, the patient's weight, a known manufacturing date and / or calibration date, the known radioactivity or other properties of the therapeutic or diagnostic agent at the time of manufacture, and a known current date and time, thereby calculating a specific patient dose. If the therapeutic or diagnostic agent is a radiopharmaceutical, any unused portion of the radiopharmaceutical and any other components that may have come into contact with the radiopharmaceutical, which may be contaminated, can be stored in a waste container for storage until the radioactivity degrades to an acceptable level (typically about 10 half-lives of the radioisotope) depending on the initial dose in the storage device. The system and method can be configured to ensure consistency of dosing in that each patient receives the desired amount of therapeutic or diagnostic agent.

[0112] As described in various embodiments or aspects of this disclosure, improved systems and methods are provided to ensure that stored products are no longer designed to be patient-specific, or do not need to be patient-specific. Instead, the systems disclosed herein are configured to administer treatment to any patient who may be present at the site on any given day, providing greater flexibility in how stored products are utilized at the site of treatment so that an effective dose of the radiopharmaceutical can be delivered to the patient. Such patient-specific dosing is achieved without the need for dose calibrators, thereby eliminating additional dose assays for preparing doses for immediate patient use.

[0113] As described in various embodiments or aspects of this disclosure, systems and methods can be provided for monitoring therapeutic or diagnostic agents stored in a waste container and indicating when the stored material has sufficiently decayed and is safe to dispose of. Once that determination is made, instructions can be provided to the user (e.g., a software prompt, or the ability to switch an LED light from red to green, or to turn off the red LED and turn on the green LED) so that staff can recognize that there is material suitable for disposal, identify the material to be disposed of, and dispose of the material appropriately.

[0114] As described in various embodiments or aspects of this disclosure, the improved inventory management flexibility associated with the systems and methods described herein allows caregivers to manage inventory more effectively, thereby eliminating the need to manage inventory using simple first-in, first-out methods and / or methods that require each stored dose to be provided to only one specific patient. Instead, inventory management and dose use are managed to take into account various factors, including the need for better management of the supply of available doses to patients. For example, if a particular patient requires a large dose due to their size (e.g., weight, height and body composition, etc.), a fresher, more radioactive vial of the radiotherapy agent can be selected and administered to the patient, resulting in only one vial (instead of multiple vials) being required for dose infusion to the patient. This makes administration easier (e.g., using only one infusion sequence) and provides greater flexibility with respect to storage management and administration, resulting in more efficient dose utilization and less waste. In some situations, this type of flexibility may also help reduce exposure to clinicians during therapeutic administration and minimize the subsequent cleanup methods after the patient has received their dose.

[0115] Figure 3 illustrates an improved supply chain for therapeutic or diagnostic agents according to several embodiments or aspects of the present disclosure. The therapeutic or diagnostic agent may be bulk manufactured at a manufacturing facility. Instead of loading the therapeutic or diagnostic agent into bulk containers for transport to a hot lab, the therapeutic or diagnostic agent is loaded into a storage device that is transported directly to the treatment site. The storage device is configured to store the therapeutic or diagnostic agent from the manufacturing site during transport and during storage at the treatment site. The therapeutic or diagnostic agent is configured to be administered directly to the patient from the storage device using a delivery system, as described herein. Dosage for specific patients is determined by the delivery system, instead of using a dose calibrator.

[0116] As shown in Figure 4, the method for diagnosing, referencing, and treating patients according to the improved supply chain eliminates several steps compared to conventional methods. After patient P is diagnosed and a dosage of therapeutic or diagnostic agent is prescribed based on the patient's weight, the dosage can be administered directly from a storage device 200 mounted within the delivery system 100 using the delivery system 100. Prescription and administration can be performed by the same authorized user AU.

[0117] Referring to Figure 5, several embodiments or aspects of the present disclosure show a delivery system 100 for the distribution, administration, and disposal of therapeutic or diagnostic agents. As described herein, the system 100 includes a number of components designed to work together to provide safe, streamlined, and flexible distribution of therapeutic or diagnostic agents. The delivery system 100 is further configured to help end users maintain and manage their stockpiles of therapeutic or diagnostic agents.

[0118] In some embodiments or aspects, the delivery system 100 may be configured to store, administer, and dispose of therapeutic or diagnostic agents, such as radiopharmaceutical therapeutic agents or radiopharmaceutical diagnostic agents. The radiopharmaceutical agents that can be stored and administered to patients may be materials present in a fluid. Radiopharmaceuticals may primarily emit alpha rays or primarily beta rays. In some embodiments or aspects, radiopharmaceuticals may primarily emit Auger radiation or positron radiation, and therefore may emit secondary gamma rays. For materials that may primarily emit beta rays, the storage device 200 and the delivery system 100 may be adapted to address secondary X-ray radiation that may be emitted as a result of beta-ray shielding, as described herein. The delivery system 100 may also be adapted to address gamma rays further emitted by the radiopharmaceutical. In some examples or aspects, the delivery system 100 may be configured for storage, administration, and disposal in XOFIGO® therapy, along with other TRT therapies that may utilize targeted alpha-ray therapy or targeted beta-ray therapy. The delivery system 100 may also be configured to function for radioisotopes that may be administered at the treatment site for therapeutic or diagnostic services (e.g., radioisotopes with very short half-lives, such as technetium-99 or copper-64, which can be used for imaging or other purposes).

[0119] In some embodiments or aspects, the delivery system 100 may be configured to store, administer, and dispose of therapeutic or diagnostic agents that are radiopharmaceuticals, such as imaging radiopharmaceuticals. In some embodiments or aspects, the imaging radiopharmaceutical may be a gamma-ray emitting imaging radiopharmaceutical. Gamma-ray emitting imaging radiopharmaceuticals include, but are not limited to, 99mTc, 123I, 111In, 67Ga, and / or 186Re. In some embodiments or aspects, the imaging radiopharmaceutical may be a positron-emitting imaging radiopharmaceutical. Positron-emitting imaging radiopharmaceuticals include, but are not limited to, 13N, 18F, 68Ga, 89Zr, 124I, 64Cu, 82Rb, and / or 86Y.

[0120] In some embodiments or aspects, the delivery system 100 may be configured to store, administer, and dispose of therapeutic or diagnostic agents, which are radiopharmaceuticals such as therapeutic radiopharmaceuticals. In some embodiments or aspects, the therapeutic radiopharmaceutical may be a beta-ray therapeutic radiopharmaceutical. Beta-ray therapeutic radiopharmaceuticals include, but are not limited to, lutetium-177, iodine-131, yttrium-90, copper-67, rhenium-188, and / or holmium-166. In some embodiments or aspects, the therapeutic radiopharmaceutical may be an alpha-ray therapeutic radiopharmaceutical. Alpha-ray therapeutic radiopharmaceuticals include, but are not limited to, radium-223, actinium-225, thorium-227, astatine-211, reed-212, and / or bismuth-213. In some embodiments or aspects, the therapeutic radiopharmaceutical may be an Auger therapeutic radiopharmaceutical. Auger therapeutic radiopharmaceuticals include, but are not limited to, terbium-161 and / or iodine-125. In some embodiments or aspects, the radiopharmaceutical is selected from the group consisting of 177Lu-oxodotreotide, 223Ra dichloride, 18F-flucyclobaine, 123I-isoflupane, 68Ga-dotate, 111In, 99mTc-chilmanocept, 99mTc-tetrophosmine, 18F-florbetaben, 99mTc, 90Y-ibritumomabuchiuxetane, 18F-florbetapyr, 153Sm-lexidronam EDTMP, 131I-iobenguan MIBG, and / or 89Sr-chloride. In some embodiments or aspects, the radionuclide of a radiopharmaceutical configured for imaging or therapeutic use is bound to FAP (fibroblast-activating protein), PSMA (prostate-specific membrane antigen), DOTA (dodecanetetraacetic acid and its chelated derivatives), HER2 (human epidermal growth factor receptor 2), GPC-3 (glypican-3 protein), or other mechanisms of action with the radiopharmaceutical.

[0121] In some embodiments or aspects, the delivery system 100 may be configured to function for radioisotopes (e.g., radioisotopes with very short half-lives, such as technetium-99m, nitrogen-13, fluorine-18, gallium-68, or copper-64) that can be prepared at the treatment site for therapeutic or diagnostic services that can be used for imaging or other purposes. These types of radioisotopes tend to have very short half-lives, and for effective use in diagnostic services, imaging personnel may need to prepare the radioisotopes at a field hot lab or central radiopharmacy. For such applications, personnel may prepare the diagnostic service material at the site. The personnel may then insert the material into a vial, place the vial in a storage device, and record and label the storage device to indicate the volume, concentration, and / or date of initial emission. The storage device may have a unique device identifier used to record content information in a software system. The storage device can then be coupled to a cassette, injector, and infusion set, as described herein, to supply the patient with the dose determined before the patient undergoes imaging. Used materials can also be stored, as described herein, in a manner similar to that for disposal.

[0122] The following is a detailed description of the various components of the delivery system 100 and how such components enable the use of the delivery system 100 for improved distribution, administration, and disposal of therapeutic or diagnostic agents.

[0123] Continuing with reference to Figure 5, a delivery system 100 according to one embodiment or aspect of the present disclosure is shown. The delivery system 100 may be configured as a portable device. The delivery system 100 includes a cart 102, which is supported by wheels 104 for moving the cart 102. In some embodiments or aspects, the delivery system 100 may be fixedly mounted. The cart 102 includes a plurality of storage compartments 106, such as shelves or drawers, for storing various components of the delivery system 100. In some embodiments or aspects, the storage compartments 106 include a first drawer or shelf 108 for storing one or more storage devices 200 before use. The first drawer 108 may have the ability to keep the storage containers 200 cold to meet the requirements of the drugs being stored. The first drawer or shelf 108 may be further configured to store infusion sets and other fluid pathway components for connecting the delivery system 100 to a patient during administration of therapeutic or diagnostic agents. The storage compartment 106 may include a second drawer or shelf 110 configured to receive components of a delivery system 100 for administering a therapeutic or diagnostic agent. For example, the second drawer or shelf 110 may be configured to house one or more assemblies 150 for administering a certain dose of a therapeutic or diagnostic agent. As described herein, each assembly 150 includes a single storage device 200 connected to a single-use fluid cassette 300. In some embodiments or aspects, the assembly 150 may include one or more multi-use storage devices 200 and multi-use fluid cassettes 300. Each assembly 150 is removably insertable into the second drawer or shelf 110. The assembly 150 is operably connectable to an injector 170 for delivering a dose of a therapeutic or diagnostic agent. The assembly 150 may be configured for single use for one patient. In some embodiments or aspects, the assembly 150 may be configured for use for multiple patients.

[0124] The delivery system 100 further includes a third drawer or shelf 112 configured to store one or more used assemblies 150. Each assembly is configured to minimize handling of the storage device 200 during the workflow. At least one of the first, second, and third drawers or shelves 108, 110, and 112 may have radiation shielding material to sufficiently reduce radiation or radioactivity outside the cart 102.

[0125] Referring further to Figure 5, the delivery system 100 further includes a controller 114 for controlling the delivery of a single dose of a therapeutic or diagnostic agent. The controller 114 may be connected to one or more user displays 116 for displaying information regarding the storage, administration, and / or disposal of the therapeutic or diagnostic agent. In some embodiments or aspects, the displays 116 are touchscreen displays that enable control via touch commands received from the user. The controller 114 may further be connected to an input device 118 for inputting data regarding the storage, administration, and / or disposal of the therapeutic or diagnostic agent. In some embodiments or aspects, the input device 118 may be a barcode scanner, a keyboard, a mouse, a touchscreen display, and / or any other input mechanism for inputting data and / or commands regarding the operation of the delivery system 100 to the controller 114. The input device 118 may include functionality for video conferencing. The controller 114 may further be connected to a camera 117. The camera may be used to provide input to the controller, such as by reading machine-readable or human-readable labels or tags. The camera may be used to capture, record, and / or communicate images of anything in progress for use by on-site operators, off-site operators, or for training or archival purposes. In some embodiments or aspects, an output device 119, such as a printer, is provided. The printer 119 may be used to print labels for documents, labels for trash cans, patient travel cards, patient reminders, and / or patient guidelines.

[0126] The controller 114 may include at least one processor programmed or configured to calculate the dose of a therapeutic or diagnostic agent to be delivered to a particular patient based on patient data and / or data relating to one or more characteristics of the therapeutic or diagnostic agent. At least one processor of the controller 114 may be further configured to actuate various components of the delivery system 100 to achieve dose delivery to the patient in accordance with a programmed protocol for the infusion procedure. The controller 114 may include a computer-readable medium, such as memory, in which one or more infusion protocols can be stored for execution by at least one processor.

[0127] The controller 114 of the delivery system 100 may be adapted to determine the dosage of a therapeutic or diagnostic agent to be given to a patient. The dosage may be determined from one or more variables given to the controller 114 via one or more input devices 118. For example, the patient's weight or other patient characteristics may be entered via a keyboard and / or mouse. The radioactivity range of the therapeutic or diagnostic radiopharmaceutical may be determined by the controller 114 based on information associated with a label or tag 270, such as a machine-readable label (e.g., barcode) or electronic tag (e.g., RFID) attached to the storage device 200 shown in Figure 16. In some embodiments or aspects, the information associated with the label or tag 270 may include manufacturing information and / or radioactivity information (e.g., manufacturing date, calibration date and time, radioactivity at calibration, radioactivity level of the material at manufacturing, fluid volume, fluid concentration, type of radioisotope, etc.). In further embodiments or aspects, the information associated with the label or tag 270 may include time and temperature history values ​​of the storage device 200 during transport and handling. This information and the current date or time may be used by the controller 114 to determine the appropriate dose for the patient by using a predetermined medication algorithm that can utilize such parameters. Some predetermined medication algorithms can also use additional parameters such as the patient's weight, the patient's sex and / or the patient's age. Some predetermined medication algorithms can also use additional parameters such as the prescribed dose and the prescribed or targeted tissue dose.

[0128] In some embodiments or aspects, the controller 118 may have various medication algorithms for various predetermined treatments. Using scanned barcodes, read RFID tags, and / or other inputs provided by the user, an appropriate medication algorithm can be selected to determine the dosage for the patient.

[0129] Continuing to refer to Figure 5, each of the storage compartments 106 is lockable and configured to be accessed by authorized users with appropriate access protocols. For example, each of the storage compartments 106 may have a lock 120 operably connected to the controller 114. The operation of the lock 120 may require the user to enter a password or other authentication means, for example, using the display 116 or input device 118, in order to authenticate an authorized user of the delivery system 100.

[0130] Continuing to refer to Figure 5, one or more of the wheels 104 of the cart 102 may have a wheel lock 122 for selectively locking the wheel 104 to prevent the cart 102 from moving. The wheel lock 122 may be configured to prevent unauthorized movement of the cart 102. For example, the wheel lock 122 may be operably connected to the controller 114. The operation of the wheel lock 122 may require the input of a password or other authentication means, for example using the display 116 or input device 118, in order to authenticate an authorized user of the delivery system 100 and allow the movement of the wheel 104. The wheel lock 122 may be a mechanical lock having a key or other mechanical locking mechanism. In some embodiments or aspects, the wheel lock 122 may be operably connected to the lock 120 of the storage compartment 106 such that the operation of one of the wheel lock 122 and lock 120 also controls the operation of the other wheel lock 122 and lock 120. In some embodiments or aspects, an alarm system may be operably connected to at least one of the lock 120 and the wheel lock 122 so as to sound an alarm or display an alarm message in the event of unauthorized use of the delivery system 100. In some embodiments or aspects, the alarm system may be configured to prevent the operation of the delivery system 100 and / or the movement of the cart 102, for example, by locking the wheel lock 122. The cart 102 may also include a compartment 113 for storing auxiliary equipment that is not directly used in the infusion method but is necessary or useful throughout the procedure. For example, this may include a survey meter or other radiation detector for inspecting the outside of the packaging and / or storage container 200 when checking into the cart. The survey meter may also be used to inspect the outside of the assembly 150 after the injector to check for leaks. The survey meter may also be used to inspect the patient, operator, and infusion chamber for contamination, and the auxiliary equipment compartment 113 may also house a spill remediation kit for abnormal cases in which spills occur, such as when the IV comes out of the patient's arm during infusion.The auxiliary equipment compartment may include other items commonly found in a hot lab and required for this infusion, because the advantage of this delivery system 100 is to provide the capabilities and equipment necessary to safely deliver the drug for which it is designed to be delivered.

[0131] Referring to Figure 6, a delivery system 100' according to another embodiment or aspect of the present disclosure is shown. Similar to the delivery system 100 illustrated and described with reference to Figure 5, the delivery system 100' shown in Figure 6 is configured as a portable device including a cart 102' supported on optional wheels. The cart 102' includes a plurality of storage compartments 106' for storing one or more storage devices 200 before use and for storing one or more used assemblies 150.

[0132] Instead of integrating the injector 170 into the cart 102, the delivery system 100' shown in Figure 6 has a separate injector 170' supported on a separate movable base 124. The injector 170' is configured to receive an assembly 150 including a storage device 200 and a fluid cassette 300. The delivery system 100' further includes a controller 114' for controlling the delivery of doses of therapeutic or diagnostic agents. The controller 114' may be connected to one or more user displays 116' for displaying information regarding the storage, administration and / or disposal of therapeutic or diagnostic agents. In some embodiments or aspects, the display 116' is a touchscreen display that enables control via touch commands received from the user. The user display 116' may be configured to input data regarding the storage, administration and / or disposal of therapeutic or diagnostic agents. In some embodiments, part of the communication may be wireless so as not to require a continuous physical connection between selected components. In some embodiments of system 100, there may be one or more fixed carts 102' and one or more portable carts 102' communicating with each other to facilitate flexible or optimal storage and use of the relevant materials. In busy work environments, used assemblies 150 may be moved from the portable carts to the fixed carts, which may provide auxiliary damping storage in place. This can be done, for example, at the end of the day by moving individual units or by moving entire drawers from one cabinet to another. The auxiliary damping cabinets in place may be in different rooms or different facilities.

[0133] Referring to Figures 7 to 9, a storage device 200 according to one embodiment or aspect of the present disclosure is shown. As described herein, the storage device 200 is configured to store a certain amount of therapeutic or diagnostic agent. In embodiments or aspects in which the therapeutic or diagnostic agent is a radiopharmaceutical, the storage device 200 is configured to contain the radiation emitted by the radioisotopes of the radiopharmaceutical.

[0134] Referring to Figure 8, the storage device 200 includes a housing 201 in which a chamber 202 is defined. The housing 201 has a body 204 that defines the chamber 202. The body 204 has a proximal end 206 having a first opening 208 and a distal end 210 having a second opening 212. The distal end 210 of the body 204 of the housing 201 is provided with a cap 214 to seal the second opening 212. In some embodiments or aspects, a gasket or seal 217 is provided at the boundary between the cap 214 and the distal end 210 of the body 204. In some embodiments or aspects, the cap 214 is irremovably connected to the body 204, for example, via one or more clips 216 (shown in Figure 9). In some embodiments or aspects, the cap 214 may be removably connected to the body 204. In some embodiments or aspects, the body 204 and cap 214 of the housing 201 may be made from, incorporated into, or housed in a shielding material such as poly(methyl methacrylate) (PMMA), lead, or tungsten.

[0135] Referring to Figure 9, the body 204 has an inner portion 218 defining a chamber 202 and an outer portion 220. The inner portion 218 may be connected to the outer portion 220 by one or more connectors 222. In some embodiments or aspects, a cavity 224 is defined between the inner portion 218 and the outer portion 220. The cavity 224 may be hollow or may be filled with one or more of the following: shielding material such as PMMA, lead or tungsten, shock-absorbing material such as polystyrene beads, or absorbent material such as paper. The filling material may be formed from one or more of the following: solid sheets in loose form such as beads or pellets, liquid, or a curing injectable filler, or a combination thereof. The inner portion 218 and the outer portion 220 may have the same shape or different shapes. For example, the inner portion 218 may have a substantially cylindrical shape, and the outer portion 220 may have a substantially rectangular parallelepiped shape. The edges of the rectangular outer portion 220 may be rounded. In some embodiments or aspects, the inner portion 218 and the outer portion 220 may be formed monolithically.

[0136] For drugs that emit beta rays, the internal structure of the storage device 200 may be designed and configured to prevent X-rays formed from beta rays from being emitted from the housing 201. This shielding of beta rays and X-rays may be achieved by the internal structure of the storage device 200, such as shielding material placed within the cavity 224. Alternatively or additionally, the side walls of the housing 201 may be selected, for example, by selecting thickness and material properties, to prevent the emission of X-rays and beta rays. In some embodiments or aspects, the storage device 200 may have a plurality of spaced-apart shields (e.g., spaced-apart shield walls) defined between the chamber 202 and the outer wall of the housing 201. In some configurations, packing material or fluid (e.g., air) may be placed within the cavity 224 to adequately shield X-rays and / or beta rays.

[0137] Alpha radiation is not difficult to block because, typically, alpha particles are large, have more limited penetrating power, and are generally administered at lower doses than beta radiation. The side walls of the housing 201 may be selected to be thick enough to shield against alpha radiation. Since many isotopes that emit alpha and beta radiation, or their daughter isotopes, also emit gamma radiation, the cavity 224 may be thickened or additional packing material may be provided to help fix the container 226 in the desired position and / or to provide additional shielding, in order to prevent additional radiation exposure from the radiopharmaceutical released outside the housing. The size of the housing 201 relative to the container 226 may be selected to set a minimum distance from the outside of the housing 201 to the container 226 in order to reduce user exposure. However, generally, isotopes emit two or more types of radiation, or radiation at various energy levels with varying penetrating powers. Furthermore, all isotopes accumulate some daughter products between the manufacture and delivery of the drug. Therefore, significant gamma-ray shielding may be necessary for devices that are nominally alpha- or beta-ray emitters. The materials used for shielding and related guidelines are well known to those skilled in the field of health physics.

[0138] Referring to Figures 8 and 9, the chamber 202 of the housing 201 is configured to hold a container 226 for containing a therapeutic or diagnostic agent 228 (shown in Figure 8). The container 226 may be a glass vial formed separately from the housing 201 of the storage device 200 and inserted into the chamber 202 of the housing 201. In some embodiments or aspects, the container 226 may be formed integrally with the storage device 200. The size of the chamber 202 is selected to accommodate the largest container 226 that can be used with the storage device 200 and / or to accommodate any additional packing or shielding material that may be required.

[0139] The container 226 has a proximal end 230 with an access port 232 and a closed distal end 234, with an interior 236 defined between the proximal end 230 and the distal end 234. The access port 232 may be a perforated partition configured to be perforated by a container access member or other access mechanism for accessing the therapeutic or diagnostic agent 228 in the interior 236 of the container 226, as described herein. During the manufacture of the therapeutic or diagnostic agent 228, the therapeutic or diagnostic agent 228 can be filled into the container 226, and the container 226 can then be sealed through the access port 232 to hold the therapeutic or diagnostic agent 228 therein. Filling of the container 226 can be performed after the container 226 has been connected or placed in the chamber 201 of the storage device 200, or before the container 226 has been connected or placed in the chamber 201. In some embodiments or aspects, the access port 232 may be completely sterilized at the manufacturing site. The container 226 may also be a plastic vial, a flexible bladder, a collapsible bag, or a pre-filled syringe, preferably having a plunger but without a handle to reduce the required space. The advantage of collapsible containers and pre-filled syringes is that, as the fluid is drawn out, the container folds or the plunger moves downward, so there is no need to introduce air into the container when the fluid is drawn out.

[0140] Referring to Figure 8, the proximal end 230 of the container 226 is positioned at the proximal end 206 of the housing 201 such that the access port 232 is positioned opposite the first opening 208. In this embodiment, the container access member can extend through the first opening 208 of the housing 201 and the access port 232 of the container 226 during administration of the therapeutic or diagnostic agent 228.

[0141] In some embodiments or aspects, the container 226 may be secured to the proximal end 206 of the housing 201 by a plurality of ribs 238 surrounding a first opening 208 within the chamber 202 of the housing 201. Each of the plurality of ribs 238 may be configured to engage with the proximal end 230 of the container 226 in order to fix the position of the access port 232 relative to the first opening 208 of the housing 201.

[0142] Referring to Figures 8 and 9, the storage device 200 has a holder 240 within a chamber 202 of the housing 201. The holder 240 may be configured to hold the distal end 234 of the container 226 relative to the housing 201. The holder 240 may contact the distal end 234 of the container 226 to fix the position of the container 226 relative to the housing 201. In some embodiments or aspects, the holder 240 includes a contact element 242 for contacting the distal end 234 of the container 226, and a plurality of tabs 244 connected to the contact element 242 and configured to engage with the housing 201, such as the inner surface 246 of the inner portion 218 of the housing 201, to fix the position of the container 226 relative to the housing 201. As shown in Figures 9 and 10, the plurality of tabs 244 may be angled relative to the contact element 242 so as to be oriented at an angle not perpendicular to the inner surface 246 of the inner portion 218 of the housing 201. The multiple tabs 244 can bend relative to the contact element 242 so that when the contact element 242 is pressed against the distal end 234 of the container 226, the multiple tabs 244 provide a restoring force against the distal movement of the holder 240 away from the distal end 234 of the container 226. In this embodiment, the holder 240 is configured to hold multiple different containers 226, regardless of their diameter and longitudinal length.

[0143] Referring to Figures 8 and 9, the storage device 200 has a door 248 associated with the housing 201. In some embodiments or aspects, the door 248 may be movable relative to the housing 201 between an open position and a closed position as shown in Figure 8. The door 248 may also be movable between a closed position and an open position in response to operation by the access mechanism of the delivery system 100, as described herein. In some embodiments or aspects, the door 248 may normally be closed. In the closed position, the door 248 is configured to cover the first opening 208 of the housing 201, thereby sealing the chamber 202 of the housing 201. In this aspect, the container 226 is completely enclosed within the chamber 202, preventing access to the access port 232. In the open position, the door 248 is moved relative to the housing 201 to expose the first opening 208 in the housing 201 for access to the access port 232 of the container 226. In some embodiments or aspects, the door 248 may be slidably movable relative to the housing in the direction of arrow A shown in Figure 9.

[0144] Continuing to refer to Figures 8 and 9, the door 248 has an access opening 250 configured to align with a first opening 208 of the housing 201 when the door 248 is in the open position. In this embodiment, a container access member can extend into the access port 232 of the container 226 through the access opening 250 and the first opening 208.

[0145] Continuing to refer to Figures 8 and 9, the door cover 252 is connected to the housing 201 and is configured to enclose the door 248 within the door chamber. The door cover 252 is irremovably connected to the body 204, for example, via one or more clips 216 (shown in Figure 9). In some embodiments or aspects, the door cover 252 may be removably connected to the body 204 of the housing 201. In some embodiments or aspects, the door cover 252 may be made from the same material as the body 204 and cap 214 of the housing 201.

[0146] Referring to Figure 9, the door cover 252 has a door access opening 254 with a seal 256 and a container access opening 258 (shown in Figure 8) positioned opposite a first opening 208 of the housing 201. The container access opening 258 is configured to receive a spike or other container access member of the delivery system during administration of a therapeutic or diagnostic agent 228. The container access opening 258 is aligned with the access opening 250 of the door 248 when the door 248 is in the open position, allowing the spike or other container access member to extend through the first opening 208 of the housing 201 to access the access port 232.

[0147] Referring to Figure 12, the seal 256 covers the door access opening 254 and is perforated by the access mechanism of the delivery system 100, as described herein. In some embodiments or aspects, the access mechanism of the delivery system 100 may be configured to detect the presence of the seal 256, for example, by detecting resistance to movement through the door access opening 254 when the seal 256 is present. If the access mechanism of the delivery system 100 does not detect the seal 256 for reasons such as the absence of resistance to movement through the door access opening 254, the controller 114 may be configured to prevent the delivery system 100 from operating on the grounds that a used storage device 200 (i.e., one with a perforated seal 256) or a tampered storage device 200 (i.e., one from which the seal 256 has been removed) is installed for use with the delivery system 100. In this aspect, the seal 256 functions as a security mechanism to ensure that only untampered storage devices 200 can be used with the delivery system 100. In some embodiments or aspects, the seal 256 may also be provided to cover the container access opening 258. In some embodiments, the seal may be a component of the housing 201 that is destroyed or permanently deformed as evidence of use or opening.

[0148] Referring to Figures 13 and 14, several embodiments or aspects of the door lock 260 are shown. The door lock 260 may be provided on the door 248 to fix the door 248 in the open position after it has moved from the closed position to the open position. In some embodiments or aspects, the door lock 260 includes at least one first hook 262, which is configured to engage with at least one second hook 264 on the housing 201 or door cover 252 (shown in Figures 8 and 9). Each of the at least one first hook 262 and the at least one second hook 264 may have an angled contact surface 266 and a catch 268 configured to engage after the two contact surfaces 266 have slid toward each other. Figure 14 shows at least one first hook 262 and at least one second hook 264 that are locked together when the door 248 is in the open position. This locked engagement prevents the door 248 from returning to the closed position.

[0149] In some embodiments or aspects, the door 248 may be movable between three different positions. In the initial state, the door 248 may be closed. In the intermediate state, the door 248 may be moved from the initial (closed) position to the open position to allow access to the container 226. In the final state, the door 248 may be moved to the closed position in which it engages with the door lock 260 to prevent the door 248 from being opened again and the remaining contents in the container 226 being accessed.

[0150] Referring to Figures 15-19, another embodiment or aspect of the storage device 200' of this disclosure is shown. Since the structure of the storage device 200' shown in Figures 15-19 is substantially similar to the structure of the storage device 200 illustrated and described with reference to Figures 7-14, a detailed description of the components of the storage device 200' is omitted. In Figures 15-19, the same reference numerals used to describe the components of the storage device 200' in Figures 7-14 are used to describe the components of the storage device 200, except that a single quote ('') is added after each reference numeral in Figures 15-19. The following detailed disclosure will focus only on the relative differences between the two storage devices.

[0151] In some embodiments or aspects, the storage device 200 may have at least one label, tag or other indicator 270 on the housing 201. The at least one label, tag or other indicator 270 is shown in relation to the embodiment of the storage device shown in Figure 16, but the at least one label, tag or other indicator 270 may be applied to any storage device 200 described herein, such as the storage device 200 described herein with reference to Figures 7 to 14. The at least one label, tag or other indicator 270 may include machine-readable certifiable data configured to be read by the delivery system 100 to authenticate the storage device 200 before use. In some embodiments or aspects, the machine-readable certifiable data includes at least one of product information, manufacturing information, prescription information and transport conditions information. At least one label, tag, or other indicator 270 may be a label (e.g., a barcode, QR code®, or similar) and / or tag (e.g., electronic, RFID, or similar) containing at least one of product information, manufacturing information, prescription information, and transport conditions information relating to a therapeutic or diagnostic agent. In some embodiments or aspects, at least one label, tag, or other indicator 270 may include a data logger configured to record, for example, temperature, shock, and / or pressure data. In some embodiments or aspects, at least one label, tag, or other indicator 270 may include a link to access information from a website or database.

[0152] In some embodiments or aspects, the storage device 200' may be configured such that the storage device 200' can be connected to the fluid cassette only in a specific orientation. In this aspect, the access opening 254' on the door cover 252' of the storage device 200' may be appropriately aligned with the fluid cassette for proper connection between the access port 232' on the container 226' and the container access member. Referring to Figures 15 to 17B, the housing 201' of the storage device 200' includes a guide mechanism 272 configured to position the storage device 200' in a desired orientation relative to the fluid cassette 300 (see, for example, Figure 28). In some embodiments or aspects, the guide mechanism 272 includes one or more geometric mechanisms such as grooves, chamfers, protrusions, holes or tabs, which may be configured to couple with a corresponding mechanism on the fluid cassette 300 to allow direct connection to the fluid cassette 300 in a given orientation.

[0153] Referring to Figures 17A and 17B, the storage device 200' may have at least one identifying feature section 274 (shown in Figure 17B) that can be used to identify specific characteristics of the storage device 200', such as the type of therapeutic or diagnostic agent contained within the storage device 200'. The at least one identifying feature section 274 may be one or more geometric features or physical indicators, such as grooves, chamfers, protrusions, holes, or tabs. Such geometric features may be used to identify a particular storage device 200' and / or to verify that the storage device 200' is a genuine storage device 200'. The at least one identifying feature section 274 may have an identification mechanism corresponding to the fluid cassette 300. The same or different identifying feature sections 274 may be used with respect to other aspects of the system, such as the storage compartment 108 and the used container compartment 112. This provides tangible feedback that the drugs in the storage container 200' are suitable for the shielding and temperature performance of the applicable storage compartment.

[0154] In some embodiments or aspects, at least a portion of the housing 201' of the storage device 200' may have a colored portion that can be used for identification purposes. For example, a specific color may be used on at least a portion of the housing 201' of the storage device 200' to identify the contents of the storage device 200', such as the type of therapeutic or diagnostic agent contained in the storage device 200'. In some embodiments or aspects, a specific color may be used on at least a portion of the housing 201' of the storage device 200' to identify the storage device 200' as a storage device 200' for training purposes only. Such a storage device 200' does not contain any therapeutic or diagnostic agents other than safe and harmless liquids that are colored so that their behavior can be optionally visualized.

[0155] Referring to Figures 18 and 19, the storage device 200' includes a housing 201' in which a chamber 202' (shown in Figure 19) is defined. The housing 201' comprises a body 204' having a proximal end 206' with a first opening 208' and a closed distal end 210'. Instead of having a cap 214 on the distal end 210 as shown in the storage devices 200 of Figures 7 to 9, the storage device 200' shown in Figures 18 and 19 has a proximal cap 276 on the proximal end 206' of the housing 201', configured to seal the first opening 208'.

[0156] Continuing to refer to Figures 18 and 19, the proximal cap 276 has a retainer 278 having a base 280 connectable to at least one of the body 204' and the door cover 252', and a retaining portion 282 projecting distally from the base 280. The retaining portion 282 has a substantially cylindrical shape having an inner surface 284 configured to engage with the container 226', and an outer surface 286 having a threaded collar 288. The threaded collar 288 is configured to screw onto a cover 290 surrounding the container 226' in the chamber 202'. The cover 290 has a threaded portion 292 configured to screw onto the threaded collar 288 of the retaining portion 282. The distal end 294 of the cover 290 has an inner engaging surface 296 configured to contact the distal end 234' of the container 226'. A seal 298 may be provided at the boundary between the retaining portion 282 and the cover 290.

[0157] Referring to Figure 20, an assembly 150 having a storage device 200 and a fluid cassette 300 is shown according to several embodiments or aspects of the present disclosure. As described herein, the assembly 150 is configured to deliver therapeutic or diagnostic agents from the storage device 200 via the fluid cassette 300 using an injector 170 (shown in Figure 5). The fluid cassette 300 is configured to be detachably connected to the injector 170 and may be connected to a saline source for saline rinsing, priming, saline test injection, and saline infusion. The fluid cassette 300 is further configured to connect to a container 226 (shown in Figure 8) of the storage device 200 for delivering therapeutic or diagnostic agents 228 to a patient using the injector 170.

[0158] In some embodiments or aspects, the storage device 200 and the fluid cassette 300 may be configured to be removably connected to each other. In other embodiments or aspects, the storage device 200 and the fluid cassette 300 may be configured to be irremovably connected to each other so that the storage device 200 cannot be detached from the fluid cassette 300 when the storage device 200 is connected to the fluid cassette 300. This type of interlock connection helps prevent undesirable contact with therapeutic or diagnostic agents. Each fluid cassette 300 may be adapted to connect to one storage device 200 or a pair of storage devices 200. In further embodiments or aspects, the fluid cassette 300 may simply be fluid-connectable to the storage device 200 without a direct physical connection between its housings.

[0159] Referring to Figure 21, the fluid cassette 300 is shown without the storage device shown in Figure 20. The fluid cassette 300 includes a housing 302 that encloses the various components of the fluid cassette 300. The housing 302 has a first part 304 and a second part 306. The first and second parts 304, 306 may be removably connected to each other or non-removably connected. In some embodiments or aspects, the fluid cassette 300 may have a substantially rectangular parallelepiped shape.

[0160] Referring to Figure 22, the first and second portions 304, 306 of the housing 302 of the fluid cassette 300 define an interior 308 configured to receive components of the fluid cassette 300. In some embodiments or aspects, the fluid cassette 300 may have a container access member such as a spike 310, a metering device such as a syringe 312, and a fluid path set 314 that is received within the interior 308 of the housing 302. The fluid path set 314 has a tube that fluidly connects the spike 310 to the syringe 312. In some embodiments or aspects, the fluid path set 314 may have a particle / air filter 317 (shown in Figure 31). In further embodiments or aspects, the fluid path set 314 may have a valve block, as described herein with reference to Figure 31. In some embodiments, the valve block may have one or more valves for controlling the flow of fluid through the spike 310, the syringe 312, and the fluid path set 314. The fluid path set 314 is further configured to connect to the infusion set described herein with reference to Figure 31.

[0161] Continuing to refer to Figure 22, the spike 310 is configured to be extendable through the spike opening 315 in the housing 302 between a retracted position and an extended position in the direction of arrow B. In the retracted position, the spike 310 is housed within the interior 308 of the housing 302. In the extended position, the spike 310 protrudes from the interior 308 of the housing 302 through the spike opening 315 so that the spike 310 can be inserted through the access port 232 (shown in Figure 8) of the container 226. The spike opening 315 of the fluid cassette 300 may be provided with an alignment element 337 for aligning the storage device 200 with respect to the fluid cassette 300 so that the spike 310 is axially aligned when the storage device 200 is connected to the fluid cassette 300 so that it can be inserted into the access port 232 of the container 226. A cap may be provided to seal the spike opening 315 before use of the fluid cassette 300.

[0162] As shown in Figure 23, the spike 310 has a body 320 having a proximal end 322, a distal end 324, and a hollow interior. The distal end 324 of the spike 310 has at least one perforating tip 326 configured to perforate the access port 232 (shown in Figure 8) of the container 226. The at least one perforating tip 326 may include two perforating tips 326, the first of which is configured to draw fluid from the container 226, and the second of which is configured to supply air to the container 226 as the fluid is drawn from the container 226. At least one perforating tip 326 is in fluid communication with the hollow interior of the body 320 of the spike 310 in order to deliver fluid from the access port 232 of the container 226 to a fluid path connector 328 adapted to connect to a fluid path set 314. In this embodiment, therapeutic or diagnostic agents from container 226 can be delivered to a fluid pathway set 314 via at least one perforated tip 326 and fluid pathway connector 328 of the spike 310. In some embodiments or aspects, the spike may have a filtered vent 329 configured to allow air to enter container 226 when the fluid is drawn out of container 226. The spike 310 may have a collar 330 extending around a body 320. In some embodiments or aspects, an absorbent material 332 may be provided in the collar 330 to absorb any dripping from the access port 232 when the spike 310 is inserted into or withdrawn from the access port 232. The spike 310 further has a drive element 334 configured to engage with a spike drive unit of the delivery system, as described herein. The drive element 334 may be an opening, slot, or other feature configured to be engaged by the spike drive unit of the delivery system to move the spike 310 between a retracted position and an extended position. As shown in Figure 22, a spike drive unit slot 336 may be provided in the housing 302 so that the spike drive unit of the delivery system can extend into the interior 308 of the housing 302 and engage with the spike 310.

[0163] Referring to Figure 22, the syringe 312 has a barrel 338 having a proximal end 340 opposite the distal end 342 and an internal chamber 344 defined between them. The proximal end 340 is open and configured to receive a plunger 346. The distal end 342 has a port 350 that communicates with a fluid pathway set 314. The plunger 346 is reciprocable within the barrel 338 of the syringe 312 via a syringe drive unit of the delivery system, as described herein. The plunger 346 is movable in the direction of arrow C, with movement of the plunger 346 proximal drawing fluid into the internal chamber 344 via the port 350, and movement of the plunger 346 distal discharging fluid from the internal chamber 344 via the port 350. As shown in Figure 21, a portion of the plunger 346 protrudes from the housing 302 through a plunger opening 352. In some embodiments or aspects, the syringe drive of the delivery system may be configured to engage with the proximal end of the plunger 346 protruding through the plunger opening 352. In other embodiments or aspects, the plunger 346 may be entirely housed within the housing 302 of the fluid cassette 300.

[0164] Referring to Figure 24, the barrel 338 of the syringe 312 has a flange 354 that protrudes radially outward from the barrel 338 at the distal end 342. The flange 354 is configured to be received in a flange slot 356 on the housing 302 so that the barrel 338 does not move relative to the housing 302 when the plunger 346 reciprocates within the barrel 338. The flange slot 356 may have a tapered shape to ensure a tight fit with the flange 354.

[0165] Referring to Figures 25A and 25B, the plunger 346 has a plunger cap 358 configured to fix the plunger 346 in a fixed position and prevent its movement so that the filling and dispensing functions of the syringe 312 (shown in Figure 22) are disabled. In some embodiments or aspects, the plunger cap 358 may be transported in a fixed configuration, and the injector 170 may be configured to release the plunger cap 358 to allow the plunger 346 to move for the filling and dispensing functions. In some embodiments or aspects, the plunger cap 358 has at least one first hook 362, which is configured to engage with at least one second hook 364 on the housing 302. Each of the at least one first hook 362 and the at least one second hook 364 may have an angled contact surface 366 and a catch 368 configured to engage after the two contact surfaces 366 have slid over each other. Figure 25B shows at least one first hook 362 and at least one second hook 364 that engage securely with each other when the plunger cap 358 is biased toward the housing 302. This secure engagement prevents the plunger 346 from moving to fill the syringe 312 with fluid or to dispense fluid from the syringe 312. The plunger cap 358 is further configured to maintain the position of the syringe 312 in a set position so that the plunger 346 can be connected to the plunger drive while the fluid cassette 300 is being installed in the delivery device 100.

[0166] Referring to Figure 26, the fluid cassette 300 has one or more alignment elements 370 for aligning the fluid cassette 300 with respect to the injector 170 (shown in Figure 5) of the delivery system 100. In some embodiments or aspects, the housing 302 of the fluid cassette 300 has a pair of alignment elements 370 configured as openings shaped to receive alignment pins 176 of the injector 170 (also shown in Figure 31). Each of the pins 176 has a tapered surface configured to position the alignment element 370 on the fluid cassette 300 as the alignment pin 176 moves toward the fluid cassette 300. Once the alignment pins 176 are inserted into the alignment elements 370, the fluid cassette 300 is positioned in the desired location relative to the injector 170 so that the spike 310 and plunger 346 can operate. For example, the alignment of the alignment pin 176 with the alignment element 370 on the fluid cassette 300 also aligns the delivery mechanism 174 with the corresponding plunger drive receiver 376 on the plunger cap 358 to move the plunger 346 during filling and distribution operations. The plunger drive receiver 376 may have a tapered shape corresponding to the tapered shape of the pin on the delivery mechanism 174. In some embodiments or aspects, the alignment element 370 further facilitates the alignment of the valves and sensors of the delivery device 100 with their corresponding positions on the fluid path set 314 in the fluid cassette 300.

[0167] Referring to Figures 27–30, a fluid cassette 300' according to another embodiment or aspect of the present disclosure is shown. Since the structure of the fluid cassette 300' shown in Figures 27–30 is substantially the same as the structure of the fluid cassette 300 illustrated and described with reference to Figures 20–26, a detailed description of the components of the fluid cassette 300' is omitted. In Figures 27–30, the components of the fluid cassette 300' are described using the same reference numerals used to describe the components of the fluid cassette 300 in Figures 20–26, except that a "'" mark is added after each reference numeral in Figures 27–30. The following detailed disclosure will focus only on the relative differences between the two storage devices.

[0168] Referring to Figure 27, the fluid cassette 300' has a housing 302' having a recess 378 shaped to receive the storage device 200' shown in Figures 15 to 19. In some embodiments or aspects, the recess 378 is shaped such that the storage device 200' is connected to the fluid cassette 300' and the resulting assembly 150 has a substantially rectangular parallelepiped shape. As described herein with reference to Figures 15 to 17B, the housing 201' of the storage device 200' includes a guide mechanism 272 configured to position the storage device 200' in a desired orientation relative to the fluid cassette 300'. For example, referring to Figure 28, the guide mechanism 272 includes one or more geometric features such as grooves, chamfers, projections, holes or tabs, which may be configured to couple with a corresponding guide mechanism 380 of the fluid cassette 300' for directly connecting the storage device 200' to the fluid cassette 300' in a given orientation. Referring to Figure 29, the fluid cassette 300' has one or more locking elements 382 for irremovably connecting the storage device 200' to the fluid cassette 300'.

[0169] Referring to Figure 31, an exemplary fluid diagram is shown illustrating the fluid path between the storage device 200 and the fluid cassette 300. As shown in Figure 31, the container 226 of the storage device 200 is fluidly connectable to the fluid path set 314 of the fluid cassette 300 via a spike 310. The fluid path set 314 may have a plurality of valves for controlling the flow of fluid from the container 226 to the infusion set 406. In some embodiments or aspects, a first valve 384 is provided downstream of the spike 310 to regulate the flow of fluid from the spike 310 to the fluid path set 314. In some embodiments or aspects, the first valve 384 may be a pinch valve, a stopcock valve, or any other type of valve configured to selectively allow the flow of fluid from the spike 310 to the fluid path set 314. In some embodiments or aspects, the first valve 384 may be operable between an open position and a closed position by an injector 170.

[0170] The fluid pathway set 314 may be configured to facilitate air removal during priming and to limit the formation of bubbles in the material flowing from the container 226 of the storage device 200 to the syringe 312, for example, by limiting abrupt changes or transitions in the inner diameter of the fluid pathway set 314 tubes. The fluid pathway set 314 may incorporate meandering fluid paths or be configured with hydrophobic membranes to preferentially separate and bypass bubbles so as to prevent any bubbles from flowing out of the syringe 312. The fluid pathway set 314 may be designed to incorporate valves or other fluid control elements such as passive valves, active valves, one-way valves, reversible valves, pinch valves, rotary valves, stopcocks, or on / off valves.

[0171] Continuing to refer to Figure 31, an air detector 180 is located downstream of the first valve 384. The air detector 180 is configured to detect air in the fluid path set 314. In some embodiments or aspects, the air detector 180 is located on the injector 170 (see Figures 5 and 32), and the fluid cassette 300 is positioned relative to the injector 170 such that the air detector 180 is configured to detect air in the fluid path set 314 downstream of the first valve 384. In some embodiments or aspects, the output from the air detector 180 may be used by a controller 114 (shown in Figure 5) of the delivery system 100 to enable or block the operation of the injector 170 depending on the presence or absence of air in the fluid path set 314. The air detector 180 may also be configured to detect the presence of therapeutic or diagnostic agents in the line from the container 226 to aid in volumetric accuracy of dose delivery.

[0172] Continuing to refer to Figure 31, the air / particle filter 317 is located downstream of the air detector 180. In some embodiments or aspects, a valve block 316 is located downstream of the air detector 180. In some embodiments or aspects, the valve block 316 may be a manifold having multiple ports that can be selectively opened or closed to allow or restrict fluid flow. For example, the valve block 316 may have a first port 388, a second port 390, and a third port 392. The valve block 316 is operable so that only two of the three ports can communicate fluidly with each other. For example, if the valve block 316 is configured such that the first and second ports 388, 390 are in fluid communication with each other and are fluid-isolated from the third port 392, the syringe 312 can be filled with a therapeutic or diagnostic agent from the container 226 via port 350. If the valve block 316 is configured such that the second and third ports 390, 392 are in fluid communication with each other and are fluid-isolated from the first port 388, then fluid from an auxiliary fluid source 394, such as a saline solution source, can be delivered to the port 350 of the syringe 312 via an auxiliary line 396. In this configuration, saline solution or other fluid can be delivered for patency checks, test infusions, or cleaning procedures, as described herein. The auxiliary line 396 is connectable to an auxiliary branch 398 of the fluid path set 314. The auxiliary line 396 includes a spike 395 for connecting to the auxiliary fluid source 394, a check valve 397, and a pair of connectors 399.

[0173] In some embodiments, a second valve 400 may be provided in the auxiliary branch 398 to control the flow of fluid to the valve block 316. In some embodiments or aspects, the valve block 316 may be operated to selectively open and close the first, second, and third ports 388, 390, and 392 via an injector 170. Similarly, the second valve 400 may be operable between an open position and a closed position via an injector 170.

[0174] Continuing to refer to Figure 31, a third valve 402 is located downstream of the port 350 of the syringe 312. The third valve 402 may be operable between an open position and a closed position via the injector 170. The air / particle filter 403 is located downstream of the third valve 402, before the fluid path set 314 terminates at the end connector 404.

[0175] Continuing to refer to Figure 31, the infusion set 406 is removably connectable to the fluid path set 314 of the fluid cassette 300 via an end connector 404. The infusion set 406 has a proximal connector 408 configured to removably connect to the end connector 404 of the fluid path set 314. In some embodiments or aspects, the end connector 404 and the proximal connector 408 may be Luer connectors. The infusion set 406 further has a distal connector 410 configured to connect to a catheter 412 or a priming cap 414. A pair of check valves 416 are provided between the proximal connector 408 and the distal connector 410. In some embodiments or aspects, the infusion set 406 may be configured to connect to a sensor device 416 having an occlusion detection sensor 418 and an air detector 420. In some embodiments or aspects, the occlusion detection sensor 418 may be configured to pressure test the integrity of the fluid path set 314 before accessing the container 226.

[0176] Referring to Figure 32, the fluid cassette 300 and storage device 200 are shown together with components of the injector 170 configured to interact with the fluid cassette 300 and storage device 200. In some embodiments or aspects, the injector 170 includes an access mechanism 172 configured to move the door 248 (shown in Figure 8) of the storage device 200 from a closed position to an open position. The injector 170 further includes a delivery mechanism 174 configured to actuate the plunger 346 of the syringe 312 in order to fill the syringe 312 with a therapeutic or diagnostic agent from the storage device 200, or to fill the syringe 312 with saline solution from an auxiliary fluid source 394 (shown in Figure 31). The delivery mechanism 174 may further be configured to actuate the plunger 346 of the syringe 312 in order to deliver the contents of the syringe 312, such as a therapeutic or diagnostic agent, or saline solution, to an infusion set 406 (shown in Figure 31). The fluid cassette 300 and its fluid path elements are shown equipped with a single syringe 312 and valve for fluid movement and control, but pumps other than the single syringe 312 may be used. In some embodiments or aspects, there may be multiple pumps, e.g., syringes 312 for drug and lavage fluid, respectively. In some embodiments, one or more pumps may be peristaltic pumps, diaphragm pumps, or piston pumps. In some embodiments, additional pumps may eliminate the need for some valves, or may benefit from the use of additional valves. In some embodiments, it is desirable to have separate pumps for drug and lavage fluid from an auxiliary fluid source 394 to provide the ability to have a dual flow, i.e., to deliver the two fluids simultaneously, so that the total volumetric flow rate can be set independently of the drug delivery rate. One advantage of dilution introduction is to reduce the possibility of patient discomfort or reaction. A second is to reduce the time the TRT is in the vein to which it is injected before it is led into the central circulation where it is diluted. See, for example, Patent Document 2 incorporated herein by reference.

[0177] Continuing to refer to Figure 32, the fluid injector has one or more alignment pins 176 configured to engage with one or more alignment elements 370 on the fluid cassette 300. When the alignment pins 176 are inserted into the alignment elements 370, the fluid cassette 300 is positioned relative to the injector 170 so that the spikes 310 and plungers 346 can be operated. The injector 170 further has an air detector 180 configured to detect air in the tubes of the fluid path set 314. In some embodiments or aspects, the injector 170 may further have a fluid detector configured to detect the presence of fluid and / or other characteristics of the fluid. In some embodiments or aspects, the injector 170 further has a valve assembly 178 configured to selectively engage with the tubes of the fluid path set 314 to regulate the flow of fluid through them.

[0178] When the storage device 200 is coupled to the fluid cassette 300 and the coupling assembly 150 is installed in the delivery system 100, the access mechanism 172 of the injector 170 is configured to move the door 248 from a closed position to an open position so that the spike 310 of the fluid cassette 300 can be extended to penetrate the access port 232 of the container 226. Referring to Figure 33, the access mechanism 172 of the injector 170 may have a probe 182 configured to extend in a direction toward the door 248 through the access opening 254 of the door cover 252 (as shown in Figure 9). In some embodiments or aspects, the probe 182 may be configured to penetrate a seal 256 on the access opening 254. The probe 182 may be configured to detect the presence of the seal 256 by, for example, sensing the resistance to movement through the door access opening 254 when the seal 256 is present, compared to the resistance to movement when the seal 256 is not present. If the probe 182 does not detect the seal 256 for reasons such as lack of resistance to movement through the door access opening 254, the controller 114 (shown in Figure 5) may be configured to prevent the operation of the delivery system 100 because a used storage device 200 (i.e., one with a perforated seal 256) or an opened storage device 200 (i.e., one from which the seal 256 has been removed) is installed in the fluid. The operation of the probe 182 may be controlled via the controller 114.

[0179] Continuing to refer to Figure 33, the fluid injector access mechanism 172 may further include a spike driver 184 configured to engage with a spike driver slot 336 (shown in Figure 23) of the spike 310. The spike driver 184 may be linearly movable from a first position corresponding to the retracted state of the spike 310 and a second position corresponding to the extended state of the spike 310, where the spike 310 penetrates the access port 232 of the container 226. The operation of the spike driver 184 may be controlled via a controller 114.

[0180] Continuing to refer to Figure 33, the delivery mechanism 174 includes a plunger drive 186 configured to actuate the plunger 346 of the syringe 312, thereby moving the plunger 346 within the barrel of the syringe 312. The plunger drive 186 is shaped to be received by a plunger drive receiver 376 such that the movement of the plunger drive 186 causes a corresponding movement of the plunger 346. The plunger drive 186 may have a motor that moves the plunger 346 linearly. The plunger drive 186 may be linearly movable in a first direction in which the barrel of the syringe 312 is configured to be filled with fluid, and in a second direction opposite to the first direction in which the fluid from the barrel of the syringe 312 is configured to be delivered through the port 350. The operation of the plunger drive 186 may be controlled via a controller 114. In some embodiments or aspects, the plunger drive 186 determines the flow rate of fluid delivered to the patient.

[0181] Continuing to refer to Figure 33, the air detector 180 is configured to detect air in the tubes of the fluid path set 314. The air detector 180 may be a photoair detector, an acoustic air detector, an ultrasonic air detector, or any other air detector configured to detect the presence of air in the tubes of the fluid path set 314. The operation of the air detector 180 may be controlled via the controller 114.

[0182] Continuing to refer to Figure 33, the valve assembly 178 may include a plurality of valves 188. In some embodiments or aspects, the plurality of valves 188 may be pinch valves configured to sandwich the pipes of the fluid path set 314. In some embodiments or aspects, the valves 188 may be rotary stopcocks or other fluid flow shutoff mechanisms. The operation of the valve assembly 178 may be controlled via the controller 114.

[0183] Referring to Figure 34, a disinfection mechanism 190 is provided for disinfecting the access port 232 of the container 226. In some embodiments or aspects, the disinfection mechanism 190 includes a movable arm 192 and a disinfection source 194. The movable arm 192 is movable relative to the storage device 200 so that the disinfection source 194 can be positioned opposite the access port 232. The disinfection source 194 may include, for example, a laser or light emitter that can emit electromagnetic energy at a wavelength capable of inactivating bacteria on the surface of the access port 232. Examples of such emittable electromagnetic energy include ultraviolet (UV) light (10-400 nanometer (nm) wavelength light), deep ultraviolet (UV-C) light (200-280 nm wavelength light), white light, infrared (IR) light, lasers, etc. (for example, the disinfection mechanism may include a UV light emitter, a UVC LED, an IR emitter, etc.). The emitted light may be continuously irradiated onto the surface of the access port 232 for a pre-selected disinfection time to deliver a sufficient energy dose to inactivate bacteria on the access port 232 before the spike 310 is inserted into the container 226 through the access port 232. In some embodiments or aspects, the disinfection source 194 may be configured to disinfect the access port 232 and the spike 310 of the container 226. In this aspect, the access port 232 and the spike 310 are disinfected for the sterile connection between them. In further embodiments or aspects, a second disinfection source 194 may be provided on the movable arm 192 to disinfect the spike 310 before it is inserted into the access port 232 of the container 226.

[0184] In some embodiments or aspects, the disinfectant source 194 may include a nozzle or sprayer capable of spraying disinfectant material onto the access port, and / or a stirring mechanism capable of wiping disinfectant onto the access port for a pre-selected disinfection period. The selected disinfection period may be based on the type of disinfectant used and the period required to eliminate a pre-selected set of bacteria using the disinfectant, or to reduce the amount of such bacteria to below a pre-selected threshold level. In some embodiments or aspects, the disinfectant material may be applied at the manufacturing site via a disinfectant-containing absorbent material similar to that of SwabCap manufactured by ICU Medical, Inc. in San Clemente, California. The door 248 may contact the access port and hold the disinfectant-containing absorbent material. The disinfectant, for example, 70% isopropyl alcohol, performs disinfection and then slowly evaporates. The continuous presence of the absorbent material held by the door 248 maintains the sterility of the access port. The absorbent material moves with the door 248 to allow access to the access port.

[0185] Referring to Figure 35, a storage container 450 for housing a plurality of storage devices 200 is shown according to one embodiment or aspect. In some embodiments or aspects, the storage container 450 may be configured to house the storage devices 200 during transport and storage before use. The storage container 450 has a housing 452 that defines an interior 454 configured to receive a plurality of storage devices 200 inside. The housing 452 may have a housing portion 456 and a lid portion 458 connected to the housing portion 456 by a hinge 460. In some embodiments or aspects, the housing 454 of the storage container 450, such as at least one of the housing portion 456 and the lid portion 458, may provide additional shielding properties to enhance radiation shielding capability. In this aspect, radiation emitted by therapeutic or diagnostic agents housed in the storage devices 200 can be contained during transport and storage.

[0186] After the therapeutic or diagnostic agent is removed from the storage device 200 and injected into the patient, the materials used to inject the therapeutic or diagnostic agent into the patient are recovered for storage and disposal. Referring to Figure 36, a waste container 462 is provided for accommodating such materials. In some embodiments or aspects, the waste container 462 is configured to accommodate the storage container 200, fluid cassette 300, and infusion tube 406 used during the injection procedure. The waste container 462 has a housing 464 that defines an interior 466 configured to receive the used storage container 200, fluid cassette 300, and infusion tube 406. In some embodiments or aspects, the housing 464 of the waste container 462 may be given shielding properties to provide radiation shielding capability. In this aspect, radiation emitted by the used storage container 200, fluid cassette 300, and infusion tube 406 can be contained for safe disposal. In some embodiments or aspects, the waste container 462 may be configured to seal the remaining fluid in the used storage container 200, the fluid cassette 300, and the infusion tube 406.

[0187] Continuing to refer to Figure 36, a label 474, optionally printed by the delivery system 100, can be affixed to the waste container 462 to prevent the waste container 462 from being opened after the used materials have been placed inside it. The label 474 may also provide information about when the materials were used and whether the waste container 462 has been stored long enough for subsequent disposal. The label 474 may have a barcode or an RFID tag so that disposal information can be provided to a computer in response to a barcode scanner or RFID reader reading the label 474.

[0188] Once the used materials are placed in the labeled waste container 462, the waste container 462 can be temporarily stored in a cart of the delivery system 100. In some embodiments or aspects, the labeled waste container 462 may be stored in a waste locker 476 as shown in Figure 37. In some embodiments or aspects, the waste locker 476 may have a plurality of drawers or shelves 478, each configured to hold a plurality of waste containers 462. The labels 474 on the waste container 462 can be scanned by a user having a portable barcode reader. If the read barcode indicates that the material in the waste container 462 has decayed sufficiently to be safe for disposal, an alarm, such as a message, sound and / or color, may indicate that the scanned waste container 462 can be removed from the waste locker 476 and disposed of using an approved disposal method.

[0189] In some embodiments or aspects, the drawers or shelves 478 of the waste locker 476 may have at least one indicator 480 (e.g., red and green LEDs) configured to indicate whether a particular waste container 462 on the drawer or shelf 478 is safe for disposal. For example, a user may scan the barcode of an individual waste container 462 to indicate that an individual waste container 462 has been added to the drawer or shelf 478 and provide other input to the inventory management computer 482. The inventory management computer 482 may then determine, based on scanned information (e.g., date of use) related to the used material, whether the stored material in each particular waste container 462 has sufficiently decayed, in order to control the state of at least one indicator 480. For example, the inventory management computer 482 can control the state of at least one indicator 480 such that the LED or other indicator means of at least one indicator 480 indicates that the material in the waste container 462 is too radioactive to be disposed of (for example, by displaying red or another message), or that the LED or other indicator means of at least one indicator 480 indicates that the material in the waste container 462 can be disposed of (for example, by displaying green or another message). Such indicators allow the user to quickly determine whether or not the waste container 462 can be disposed of. This eliminates the need for the user to periodically scan the containers or check the use date on the label 474 of each waste container 462 to determine the disposal status of the waste containers 462.

[0190] The waste locker 476 may have a door 484 that seals its interior and a locking mechanism 486 for securing the door 484. In some embodiments or aspects, the locking mechanism 486 may be configured so that only a sufficiently qualified user can open the door 484 to access the waste locker 476. For example, the locking mechanism 486 may require the user to have a key to unlock the door 484, or to have a user badge or access associated with user login to give input to the controller to unlock the door 484.

[0191] Among the features, capabilities, and advantages provided by the systems and methods described herein are the minimization of connections that must be made, the minimization of connections that must be separated or disconnected, and the storage of each connection as much as possible. In some embodiments, methods, or systems, the only connection to be separated is the connection to the patient, which is preferably done only after all drugs have been delivered and the delivery connections have been cleaned with drugs. Thus, the possibility of dripping, spilling, or leaking of released liquid drugs, aerosols, vapors, or gases that could pose a danger to the operator or others nearby is extremely low. Some radioactive daughter products are gases. Chemotherapy aerosols can be hazardous to people in the vicinity.

[0192] Referring to Figure 38, an exemplary method for test infusion prior to delivery of a therapeutic or diagnostic agent is shown. In 500, patient P is connected to the delivery system 100 via an infusion set 406, and patient P is administered a test injection of saline or other fluid. For example, injector 170 may operate to fill syringe 312 with saline or other fluid from an auxiliary fluid source 394 and deliver the test injection of saline or other fluid to the patient via infusion set 406. The volume of saline or other fluid delivered to the patient may be sufficient to determine whether the saline or other fluid has been delivered to the patient's vascular system, leached out of the container, or leaked into the tissue. In 502, patient P and the authorized user AU administering treatment to patient P verify whether the test injection of saline or other fluid was successful. For example, the authorized user AU may visually check the injection site for signs of overflow and / or palpate the injection site. Patient P may report any discomfort associated with the test injection of saline or other fluids.

[0193] Continuing to refer to Figure 38, at 504, patient P is administered a pre-infusion portion of saline or another fluid. For example, the syringe 312 may be filled with saline or another fluid from an auxiliary fluid source 394, and the injector 170 may be operated to deliver a test infusion portion of saline or another fluid to the patient via the infusion set 406 in a larger volume and for a longer period than during the test injection at 500. In some or all embodiments, the infusion volume, infusion duration and / or infusion rate are selected to correspond to the infusion volume, infusion duration and / or infusion rate for the delivery of a therapeutic or diagnostic agent. Studies have demonstrated that initiating the saline infusion at full infusion rate reduces the likelihood of spillage and provides time for spillage to be detected if it is likely to occur. At 506, patient P is administered an injection portion of a therapeutic or diagnostic agent using a predetermined injection protocol. This method may follow the pre-infusion of the previous method, unless the operator intervenes.

[0194] Referring to Figure 39, an exemplary method for administering a therapeutic or diagnostic agent using the delivery system 100 is shown. In 510, the delivery system 100 is prepared for the administration procedure. For example, in 512, one or more storage devices 200 are mounted in one or more storage compartments 106 of the cart 102. In 514, a fluid cassette 300 is mounted in the injector 170. For example, the fluid cassette 300 is placed in a second drawer or shelf 110 of the cart 102 so that the fluid cassette 300 engages with the injector 170. In some embodiments or aspects, alignment elements 370 on the fluid cassette 300 are configured to engage with alignment pins 176 (shown in Figure 26) of the fluid injector to position the fluid cassette 300 relative to the injector 170 so that various components of the injector 170 can interact with corresponding components of the fluid cassette 300.

[0195] Continuing to refer to Figure 39, at 516, an auxiliary fluid source 394 is connected to the fluid cassette 300. For example, the auxiliary fluid source 394 may be fluid-connected to the fluid path set 314 of the fluid cassette 300 via an auxiliary line 396 (as shown in Figure 31). At 518, the storage device 200 is connected to the fluid cassette 300. In some embodiments or aspects, a label, tag, or other indicator 270 (as shown in Figure 16) on the storage device 200 may be scanned before or during connection to the fluid cassette 300 in order to load information about the contents of the storage device 200 into the controller 114.

[0196] In 520, the infusion set 406 is fluidly connected to the fluid path set 314 of the fluid cassette 300 (as shown in Figure 31), and the fluid path set 314 and the infusion set 406 are primed. In some embodiments or aspects, the controller 114 of the delivery system 100 (as shown in Figure 5) may be configured to initiate the priming procedure, in which case the syringe 312 is operated to draw fluid from the auxiliary fluid source 394 into the fluid path set 314 and deliver the fluid to the infusion set 406, thereby priming the fluid path set 314 and the infusion set 406 with fluid.

[0197] Continuing to refer to Figure 39, at 522, the test injection procedure is performed. In some embodiments or aspects, the test injection procedure may include 500-504, which are described herein with reference to Figure 38.

[0198] In 524, the delivery system 100 is configured to administer a therapeutic or diagnostic agent to a patient. For example, a syringe 312 may be filled with a therapeutic or diagnostic agent from a container 226 of a storage device 200 and operated to deliver the therapeutic or diagnostic agent to patient P via an infusion set 406 based on a predetermined administration protocol. In some embodiments or aspects, the delivery system 100 can be configured to administer a unit dose to a patient, where the unit dose requires the delivery of the entire contents of the container 226. In other embodiments or aspects, the delivery system 100 can be configured to administer a non-unit dose to a patient, where the non-unit dose requires the delivery of a portion of the entire contents of the container 226.

[0199] Continuing to refer to Figure 39, at 526, once the administration procedure is complete, the infusion set 406 is detached from patient P, and the storage device assembly 150 and fluid cassette 300 are removed from the injector 170. At 528, the used storage device 200, fluid cassette 300 and infusion set 406 are placed in the waste container 462, and a label 474 is affixed to the waste container 462 before it is placed in temporary storage on the cart 102. For example, the waste container 462 may be placed in the third drawer or shelf 112 of the cart 102.

[0200] In 530, the treatment room is cleaned and the delivery system 100 is ready for another administration procedure. In 532, the waste container 462 is moved to the waste locker 476 for further decay-in-place of the radioactive material.

[0201] The use of labels, tags, or other indicators 270 on storage devices 200 for administering new doses and storing used materials for disposal can also provide sufficient information to prompt orders for new doses. For example, the inventory system may include a computer that receives information about used storage devices 200, such as based on information contained in labels, tags, or other indicators 270 (shown in Figure 16), and determines whether the number of available doses falls below a pre-selected threshold for issuing an order for additional doses, such as based on the number of available storage devices 200. Optionally, the inventory system may compare the number of available doses with the patient scheduling load. In some situations, the inventory system may communicate this status to the distribution system, resulting in an automated message being sent to the customer flagging low inventory and prompting the submission of a new purchase order for additional doses. The inventory system may include software configured to facilitate the use of the inventory system. For example, the software may be configured to facilitate inventory management and ordering, generation / acceptance of written instructions, and generation of compliance reports. Furthermore, the use of labels, tags, or other indicators 270 on the storage device 200 for administering new doses and for storing used materials for disposal may also provide sufficient information to prompt invoices regarding the use of the drug and system, if it is a business arrangement.

[0202] While embodiments or aspects have been described in detail for illustrative and explanatory purposes, it should be understood that such details are for that purpose only, and the embodiments or aspects are not limited to those disclosed, but rather are intended to cover modifications and equivalent configurations that fall within the spirit and scope of the appended claims. For example, it should be understood that, wherever possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. In fact, many of these features can be combined in ways not specifically described in the claims and / or disclosed herein. Each dependent claim listed below may depend directly on only one claim, but the disclosure of possible implementations includes each dependent claim combined with all other claims in the claim set. [Explanation of Symbols]

[0203] 100 Delivery system, delivery device, 100' Delivery system, 102 Portable cart, 102' Fixed cart, 104 Wheels, 106 Storage compartment, 106' Storage compartment, 108 First drawer or shelf, 110 Second drawer or shelf, 112 Third drawer or shelf, container compartment, 113 Auxiliary equipment compartment, 114 Controller, 114' Controller, 116 User display, 116' User display, 117 Camera, 118 Input device, 119 Output device, printer, 120 Lock, 122 Wheel lock, 124 Movable base, 150 Coupling assembly, 170 Injector, 170' Injector, 172 Access mechanism, 174 Delivery mechanism, 176 Alignment pin, 178 Valve assembly, 180 Air detector, 182 Probe, 184 Spike drive device, 186 Plunger drive mechanism, 188 Valve, 190 Disinfection mechanism, 192 Movable arm, 194 Second disinfectant source, 200 Storage device, storage container, 200' Storage device, storage container, 201 Housing, chamber, 201' Housing, 202 Chamber, 202' Chamber, 204 Body, 204' Body, 206 Proximal end, 206' Proximal end, 208 First opening, 208' First opening, 210 Distal end, 210' Distal end, 212 Second opening, 214 Cap, 216 Clip, 217 Gasket or seal, 218 Inner part, 220 Outer part, 222 Connector, 224 Cavity, 226 Container, 226' Container, 228 Therapeutic or diagnostic agent, 230 Proximal end, 232 Access port, 232' Access port, 234 distal end, 234' distal end, 236 interior, 238 rib, 240 holder, 242 contact element, 244 tab, 246 inner surface, 248 door, 250 access opening, 252 door cover, 252' door cover, 254 door access opening, 254' access opening, 256 seal, 258 container access opening, 260 door lock, 262 first hook, 264 second hook, 266 contact surface, 268 catch, 270 label or tag, indicator, 272 guide mechanism, 274 identification feature, 276 proximal cap, 278 retainer, 280 base, 282 retaining part, 284 inner surface, 286 outer surface, 288 threaded collar, 290Cover, 292 threaded section, 294 distal end, 296 inner engagement surface, 298 seal, 300 fluid cassette, 300' fluid cassette, 302 housing, 302' housing, 304 first part, 306 second part, 308 interior, 310 spike, 312 syringe, 314 fluid path set, 315 spike opening, 316 valve block, 317 particle filter, air filter, 320 body, 322 proximal end, 324 distal end, 326 puncture tip, 328 fluid path connector, 329 vent with filter, 330 collar, 332 absorbent material, 334 drive element, 336 spike drive unit slot, 337 alignment element, 338 barrel, 340 proximal end, 342 distal end, 344 Internal chamber, 346 plunger, 350 port, 352 plunger opening, 354 flange, 356 flange slot, 358 plunger cap, 362 first hook, 364 second hook, 366 contact surface, 368 catch, 370 alignment element, 376 plunger drive receiver, 378 recess, 380 guide mechanism, 382 locking element, 384 first valve, 388 first port, 390 second port, 392 third port, 394 auxiliary fluid supply source, 395 spike, 396 auxiliary line, 397 check valve, 398 auxiliary branch, 399 connector, 400 second valve, 402 third valve, 403 air / particle filter, 404 end connector, 406 infusion set, infusion tube, 408 proximal connector, 410 Distal connector, 412 Catheter, 414 Priming cap, 416 Check valve, Sensor device, 418 Obstruction detection sensor, 420 Air detector, 450 Storage container, 452 Housing, 454 Interior, Housing, 456 Storage section, 458 Lid section, 460 Hinges, 462 Labeled waste container, 464 Housing, 466 Interior, 474 Labels, 476 Locker, 478 Drawer or shelf, 480 Indicator, 482 Inventory management computer, 484 Door, 486 Locking mechanism

Claims

1. A storage device configured to connect to a delivery system for delivering therapeutic or diagnostic drugs, wherein the storage device is A housing with a defined chamber inside, A container placed within the chamber, configured to receive the therapeutic or diagnostic agent, having a distal end opposite a proximal end, with an interior defined between them, and the proximal end having an access port for accessing the interior; A door associated with the housing, which is movable relative to the housing between a closed position and an open position, and in the closed position covers the opening of the housing to seal the chamber of the housing, and in the open position exposes the opening of the housing to access the access port of the container, A holder that contacts the container within the chamber of the housing to secure the container to the housing, such that the access port of the container is positioned at the opening of the housing, Equipped with, The door is movable between the closed position and the open position in response to operation by the access mechanism of the delivery system. Storage device.

2. The storage device according to claim 1, wherein the holder comprises a contact element for contacting the distal end of the container, and a plurality of tabs connected to the contact element and configured to engage with the inner surface of the housing to fix the distal end of the container relative to the housing.

3. The storage device according to claim 1, further comprising a plurality of ribs within the chamber of the housing, the plurality of ribs surrounding the opening, the plurality of ribs configured to fix the proximal end of the container to the housing.

4. The storage device according to claim 1, further comprising a lock for fixing the door in either the open position or the closed position.

5. The storage device according to claim 1, further comprising a door cover connected to the housing, wherein the door cover surrounds the door within the door chamber.

6. The storage device according to claim 5, wherein the door cover comprises a door access opening having a seal and a container access opening positioned opposite the opening of the housing.

7. The storage device according to claim 6, wherein the seal can be perforated by the access mechanism of the delivery system.

8. The storage device according to claim 1, further comprising on the housing a label or tag containing machine-readable certifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.

9. The storage device according to claim 1, wherein the opening of the housing is configured to receive a container access member extending into the access port to access the therapeutic or diagnostic agent contained in the container when the door is in the open position.

10. The storage device according to claim 1, wherein the therapeutic agent or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

11. An assembly configured to connect to a delivery system for delivering therapeutic or diagnostic agents, wherein the assembly is A storage device for containing the aforementioned therapeutic or diagnostic agent, A fluid cassette that can be fluidly connected to the storage device to access the aforementioned therapeutic or diagnostic agent, Equipped with, The aforementioned storage device is A housing with a defined chamber inside, A container placed within the chamber, having an interior configured to receive the therapeutic or diagnostic agent, and an access port for accessing the interior, A door associated with the housing, which is movable relative to the housing between a closed position and an open position, and in the closed position covers the opening of the housing to seal the chamber of the housing, and in the open position exposes the opening of the housing to access the access port of the container, Equipped with, The aforementioned fluid cassette is A container access member, a measuring device, and a fluid path set for fluidly connecting the container access member to the measuring device, The container access member, the measuring device, and the housing surrounding the fluid path set, Equipped with, The storage device and the fluid cassette are configured to be connected to the delivery system such that the door of the storage device is accessible by the access mechanism of the delivery system, and the container access member and the metering device of the fluid cassette are accessible by the delivery mechanism of the delivery system. assembly.

12. The assembly according to claim 11, wherein the container access member of the fluid cassette is insertable into the access port of the container when the door is moved to the open position in order to fluidly connect the metering device to the container via the fluid path set.

13. The assembly according to claim 11, wherein the fluid path set comprises one or more valves that can be operated by the delivery mechanism of the delivery system to regulate the flow of fluid through the fluid path set.

14. The assembly according to claim 11, wherein the fluid cassette is connectable to a saline solution supply source.

15. The assembly according to claim 11, wherein the storage device comprises a guide mechanism configured to position the storage device in a desired orientation relative to the fluid cassette.

16. The assembly according to claim 15, wherein the guide mechanism comprises one or more geometric feature portions on the storage device, and the one or more geometric feature portions are configured to be coupled with one or more corresponding geometric feature portions on the fluid cassette.

17. The assembly according to claim 11, wherein the outlet of the metering device of the fluid cassette is configured to connect to the infusion set in order to deliver a dose of the therapeutic or diagnostic agent from the container to the infusion set.

18. The assembly according to claim 11, further comprising on the housing a label or tag containing machine-readable certifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.

19. The assembly according to claim 11, wherein the therapeutic agent or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

20. A delivery system for delivering therapeutic or diagnostic drugs, wherein the delivery system is An injector having a delivery mechanism and an access mechanism, A fluid delivery assembly that is removably connectable to the injector, A storage device for containing the aforementioned therapeutic or diagnostic agent, A fluid cassette that can be fluidly connected to the storage device to access the aforementioned therapeutic or diagnostic agent, A fluid delivery assembly comprising, Equipped with, The aforementioned storage device is A housing with a defined chamber inside, A container placed within the chamber, having an interior configured to receive the therapeutic or diagnostic agent, and an access port for accessing the interior, A door associated with the housing, which is movable between a closed position and an open position relative to the housing via the access mechanism of the injector, and in the closed position covers the opening of the housing to seal the chamber of the housing, and in the open position exposes the opening of the housing to access the access port of the container, Equipped with, The aforementioned fluid cassette is A container access member, a measuring device, and a fluid path set for fluidly connecting the container access member to the measuring device, The container access member, the measuring device, and the housing surrounding the fluid path set, Equipped with, The container access member and the metering device of the fluid cassette are accessible by the delivery mechanism of the injector in order to fluidly connect the inside of the container to the metering device via the fluid path set. Delivery system.

21. The delivery system according to claim 20, further comprising an injector controller configured to determine the dose of the therapeutic or diagnostic agent to be drawn from the container into the weighing device based on machine-readable verifiable data on the storage device.

22. The delivery system according to claim 21, wherein the injector controller is further configured to determine the dose of the therapeutic or diagnostic agent to be drawn from the container into the measuring device based on at least one patient parameter.

23. The delivery system according to claim 22, wherein the injector controller is configured to be connected to a hospital network system.

24. The delivery system according to claim 22, wherein the injector controller comprises a plurality of drug delivery algorithms for various predetermined treatment or diagnostic procedures.

25. The delivery system according to claim 20, wherein the fluid path set comprises one or more valves that can be operated by the delivery mechanism of the delivery system to adjust the flow of fluid through the fluid path set.

26. The delivery system according to claim 20, wherein the fluid cassette is connectable to a saline solution supply source.

27. The delivery system according to claim 20, wherein the outlet of the metering device of the fluid cassette is configured to be connected to the infusion set in order to deliver a dose of the therapeutic or diagnostic agent from the container to the infusion set.

28. The delivery system according to claim 20, wherein the storage device is configured to be removably or non-removably connected to the fluid cassette.

29. The delivery system according to claim 20, further comprising on the housing a label or tag containing machine-readable certifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.

30. The delivery system according to claim 20, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and the housing includes a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

Images