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

Abstract

Systems and methods for the dispensing, storage, delivery, administration, and / or disposal of one or more therapeutic or diagnostic agents are disclosed. A storage device configured to connect to a delivery system for delivering a therapeutic or diagnostic agent has a housing with a chamber, a vessel with an access port located 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 enclose the chamber, and in the open position, the door uncovers the opening for accessing the access port of the vessel. The door is movable between the closed position and the open position in response to actuation of an access mechanism of the delivery system.

Description

[0001] This application is a divisional application of the Chinese national phase application of PCT international patent application PCT / US2023 / 062890, filed on February 20, 2023, with application number 202380023028.4.

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Application No. 63 / 312,145, filed February 21, 2022; and U.S. Provisional Application No. 63 / 312,148, filed February 21, 2022, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] This disclosure relates to systems and methods for packaging, dispensing, storing, administering, and / or discarding radiopharmaceuticals (e.g., radiopharmaceuticals for treatment or imaging). This disclosure also relates to systems and methods for packaging, dispensing, storing, administering, and / or discarding therapeutic or diagnostic agents that require precise volumetric delivery from a controlled source. Background Technology

[0005] Radiopharmaceuticals can be used for targeted radionuclide therapy (TRT) or diagnostic imaging. A radiopharmaceutical typically comprises a radioisotope (e.g., Ac-255, Lu-177, etc.), a target moiety or biological carrier (e.g., antibody, peptide, antigen, small molecule, etc.), and an optional chelating agent (e.g., DOTA, NOA, DTPA, etc.) linked together to form a single structure. In some cases, when the radioisotope is a radioisotope naturally absorbed into tissues or organs by the body, TRT may consist solely of the radioisotope without a biological carrier or chelating agent. Radiopharmaceuticals are configured to interact with target proteins on cells (e.g., cancer cells). Radiopharmaceuticals can be in liquid or fluid form. In some examples or aspects, radiopharmaceuticals may be solid particles entrained in a fluid (e.g., a serous fluid suitable for injection into a patient). Administration is typically via intravenous administration into the systemic circulation.

[0006] Examples of TRTs may include targeted alpha therapy (TAT) or targeted beta therapy (TBT). This therapy can be administered as a single therapy or in combination, for example, by simultaneous or sequential administration. The radioactive therapeutic agent of TAT primarily emits alpha rays. Residual emitted radiation from the radioactive therapeutic agent of TAT may include gamma and / or beta radiation. The radioactive therapeutic agent of TBT primarily releases beta rays. Residual emitted radiation from the radioactive therapeutic agent of TBT may include gamma and / or alpha radiation. Examples of targeted alpha therapies include, but are not limited to, therapies based on thorium (Th-227), actinium (Ac-225), and lead (Pb-212). Examples of targeted beta therapies include therapies based on lutetium (Lu-177), copper (Cu-67), or iodine (I-131). Other examples of radioactive therapeutic agents may include alpha therapeutic agents utilizing radium (Ra) (e.g., Ra-223 isotopes, such as the XOFIGO® therapy offered by Bayer Healthcare). The preparation method, prepared solution, and uses of XOFIGO® are described in U.S. Patent No. 6,635,234, the disclosure of which is incorporated herein by reference in its entirety.

[0007] The use of radiopharmaceuticals in TRT can present significant challenges in their production, storage, distribution, administration, handling, and disposal. Because the therapeutic agents are radioactive, they pose a radiation exposure risk to human health. Furthermore, given the decay properties of radiopharmaceuticals, the longer the time spent manufacturing, handling, and delivering them to patients, the less radioactivity remains in the administered dose. Numerous regulations must be followed to ensure the safe storage and use of radioactive materials. These regulations affect how the agents are stored and delivered, and who can use or administer radiotherapy agents. For example, these regulations may require care providers to undergo hundreds of hours of training to be able to administer any TRT.

[0008] Figure 1 The standard supply chain for TRT is illustrated. Initially, radiopharmaceuticals are mass-produced in a manufacturing facility and loaded into bulk containers. These containers are transported to a nuclear pharmacy, where, for example, a nuclear pharmacist draws a specific dose of the drug into a syringe according to the activity prescribed for a particular patient. The patient-prepared dose is checked in a dosing calibrator at the nuclear pharmacy to verify the prescribed dose and assay. The dose is calibrated according to the injection time to ensure that the dose has the necessary activity at the time of injection. The validated dose is then transported to the treatment site, where it is revalidated in a dosing calibrator. At the treatment site, due to the half-life of the radioactive material, the dose must typically be used within a certain number of hours of its extraction before it is no longer suitable for the patient. After administration, the used syringe is checked again in a dosing calibrator to verify that the correct prescribed dose was administered to the patient.

[0009] like Figure 2As shown, the methods for diagnosing, referring, and treating patients require multiple approaches and many different medical professionals. After patient P is diagnosed by physician D, physician D prescribes a specific dose of radiopharmaceutical based on a dosage protocol. This dose is filled by a nuclear pharmacist NP in the nuclear pharmacy before being delivered to the authorized user AU to verify the dose, administer the dose, and confirm that the correct dose has been delivered to the patient.

[0010] Conventional methods of dispensing and administering TRTs and other therapeutic or diagnostic agents require precise volumetric delivery from a controlled source, which severely limits their applicability and use. After considering transportation, processing, and patient scheduling, treatment sites have only a limited time to administer the dose to a specific patient. The challenges posed by the variability in transportation, processing, and patient scheduling can affect the efficacy of TRTs or other therapeutic or diagnostic agents, such as underdosing when delivering the drug to the patient. Due to these challenges associated with conventional systems and methods for dispensing and administering TRTs and other therapeutic or diagnostic agents, and the need for precise volumetric delivery from a controlled source, there is a need in the art for improved systems and methods for the dispensing, processing, administration, and disposal of such treatments. Summary of the Invention

[0011] Given the shortcomings of conventional systems and methods used for dispensing, handling, administering, and discarding TRT and other therapeutic or diagnostic agents, a better supply chain approach is needed to ensure that TRT is available at treatment sites and can be used long-term. Furthermore, improved systems and methods are needed to ensure that stored products are no longer targeted at specific patients. Instead, treatment sites can provide equipment to assist in treating any patient who might be at that site on any given day, allowing for greater flexibility in how stored products are used at treatment sites, thus enabling the delivery of effective doses of radiopharmaceutical to patients. This patient-specific dosing is accomplished without the need for treatment site dosing calibrators, reducing or eliminating the need for manual measurements and handling in designated thermal laboratories. Dosage, volume, and concentration can be precisely measured at manufacturing or filling sites, where dosing and filling equipment is more efficient, such as multi-dose calibrators with error detection and correction, automated sample handling, automated data recording, and accurate weighing or volume determination. More precise equipment and reduced or eliminated opportunities for human error increase the reliability of the entire supply chain.

[0012] In some embodiments or aspects of this disclosure, a storage device is provided configured to connect to a delivery system for delivering therapeutic or diagnostic agents. The storage device may include: a housing having a chamber defined therein and a vessel positioned within the chamber. The vessel may have a distal end opposite a proximal end, with an interior defined between the distal and proximal ends and configured to receive a therapeutic or diagnostic agent. The proximal end of the vessel may have an access port for accessing the interior. The storage device may also have a door associated with the housing, movable relative to the housing between a closed position and an open position. In the closed position, the door may cover an opening in the housing to close the chamber of the housing. In the open position, the door may expose an opening in the housing to access the access port of the vessel. The storage device may also have a support located within the chamber of the housing and in contact with the vessel to secure the vessel relative to the housing such that the access port of the vessel is located at the opening in the housing. The door may move between the closed and open positions in response to actuation of an access mechanism of the delivery system.

[0013] In some embodiments or aspects of this disclosure, the support may include a contact element for contacting the distal end of the vessel and a plurality of tabs connected to the contact element and configured to engage an inner surface of the housing to secure the distal end of the vessel relative to the housing. The storage device may also include a plurality of ribs located within a cavity of the housing and surrounding an opening. The plurality of ribs may be configured to secure the proximal end of the vessel relative to the housing.

[0014] In some embodiments or aspects of this disclosure, the storage device may also include a lock for locking the door in one of an open position and a closed position. A door cover may be attached to the housing, wherein the door cover closes the door within a door cavity. The door cover may include a door access opening with a seal, and a vessel access opening positioned opposite an opening in the housing, for example via a spike. The seal may be punctured by the access mechanism of the delivery system.

[0015] In some embodiments or aspects of this disclosure, the storage device may also include a label or tag or data carrier on the housing, the label or tag or data carrier containing machine-readable, authenticable data, including at least one of product information, manufacturing information, prescription information, and shipping condition information. When the door is in the open position, an opening in the housing may be configured to receive a spike extending into an access port for accessing a therapeutic or diagnostic agent. In some embodiments or aspects, the therapeutic or diagnostic agent may be a radiopharmaceutical, wherein the housing includes a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0016] In some embodiments or aspects of this disclosure, an assembly is provided configured to connect to a delivery system for delivering therapeutic or diagnostic agents. The assembly may include: a storage device containing the therapeutic or diagnostic agent, and a fluid cartridge fluidly connected to the storage device for accessing the therapeutic or diagnostic agent. The storage device may include a housing having a chamber defined therein and a vessel located within the chamber. The vessel may have an interior configured to receive the therapeutic or diagnostic agent and an access port for accessing the interior. The storage device may also include a door associated with the housing, movable relative to the housing between a closed position and an open position. In the closed position, the door may cover an opening in the housing to close the chamber of the housing. In the open position, the door may expose an opening in the housing to access the access port of the vessel. The fluid cartridge may include: a spike, a metering device, and a fluid path kit for fluidly connecting the spike to the metering device. The fluid cartridge may also include a housing that encloses the spike, the metering device, and the fluid path kit. The storage device and fluid cartridge can be configured to connect to the delivery system such that the door of the storage device can be accessed by the access mechanism of the delivery system, and the metering device and spikes of the fluid cartridge can be accessed by the delivery mechanism of the delivery system.

[0017] In some embodiments or aspects of this disclosure, when the door is moved to the open position, the spikes of the fluid cartridge can be inserted into the access port of the vessel to fluidly connect the metering device to the vessel via a fluid path kit. The fluid path kit may include one or more valves, which are operable by the delivery mechanism of the delivery system for regulating the flow rate of fluid through the fluid path elements. The fluid cartridge may be connected to a saline source.

[0018] In some embodiments or aspects of this disclosure, the storage device may include a guiding mechanism configured to position the storage device relative to the fluid cartridge in a desired orientation. The guiding mechanism may include one or more geometric features on the storage device. The one or more geometric features may be configured to mate with corresponding one or more geometric features on the fluid cartridge. The one or more geometric features may prevent mating between incompatible system components.

[0019] In some embodiments or aspects of this disclosure, the outlet of the metering device of the fluid cartridge may be configured to connect to an infusion kit for delivering a dose of therapeutic or diagnostic agent from the vessel to the infusion kit. The storage device may also include a label or tag on the housing containing machine-readable, authenticable data, including at least one of product information, manufacturing information, prescription information, and shipping condition information. The therapeutic or diagnostic agent may be a radiopharmaceutical, wherein the housing includes a shield configured to prevent a large amount of radiation from the radiopharmaceutical from being emitted from the housing.

[0020] In some embodiments or aspects of this disclosure, a delivery system for delivering therapeutic or diagnostic agents is provided. The delivery system may include: an injector having a delivery mechanism and an access mechanism, and a fluid delivery assembly removably connected to the injector. The fluid delivery assembly may include: a storage device containing the therapeutic or diagnostic agent, and a fluid cartridge fluidly connected to the storage device for accessing the therapeutic or diagnostic agent. The storage device may include: a housing having a chamber defined therein, and a vessel located within the chamber. The vessel may have an interior configured to receive the therapeutic or diagnostic agent and an access port for accessing the interior. The storage device may also include a door associated with the housing, the door being movable relative to the housing between a closed position and an open position via the injector's access mechanism. In the closed position, the door may cover an opening in the housing to close the chamber of the housing. In the open position, the door may expose an opening in the housing to access the access port of the vessel. The fluid cartridge may include: a spike, a metering device, and a fluid path kit for fluidly connecting the spike to the metering device. The fluid cartridge may also include a housing that encloses the spike, the metering device, and the fluid path kit. The metering device and spikes of the fluid cartridge can be accessed by the delivery mechanism of the injector for fluidly connecting the interior of the vessel to the metering device via a fluid path kit.

[0021] In some embodiments or aspects of this disclosure, the delivery system further includes an injector controller configured to determine the dose of a therapeutic or diagnostic agent to be drawn from the vessel into the metering device based on machine-readable authentication data on a storage device. The injector controller may also be configured to determine the dose of the therapeutic or diagnostic agent to be drawn from the vessel into the metering 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 multiple dosing algorithms for different predefined treatment or diagnostic procedures.

[0022] In some embodiments or aspects of this disclosure, the fluid pathway kit may include one or more valves, operable by the delivery mechanism of the delivery system, for regulating the flow rate of fluid through the fluid pathway elements. The fluid cartridge may be connected to a source of saline or other flushing fluid. The outlet of the fluid cartridge's metering device may be configured to connect to the infusion kit for delivering a dose of therapeutic or diagnostic agent from a vessel to the infusion kit. The storage device may be configured to be removably or non-removably connected to the fluid cartridge.

[0023] In some embodiments or aspects of this disclosure, a storage device is provided for managing the storage and disposal of used therapeutic or diagnostic agents. The storage device may include a trolley having storage compartments accessible through a lockable door. The storage compartments may be configured to store one or more disposal containers. Each disposal container may include a storage device having a housing defining a chamber therein; and a vessel located within the chamber of the housing. The vessel may be configured to store radiopharmaceutical therein. A door may be attached to the housing and movable between an open position and a closed position. In the closed position, the door may completely close the chamber of the housing. The device may also include a fluid cartridge having spikes and a metering device. The storage device may be attached to the fluid cartridge such that the spikes are inserted into the vessel to fluidly connect the metering device to the vessel. The metering device may be connected to an infusion kit for injecting a dose of radiopharmaceutical. The infusion kit, storage device, and fluid cartridge may be held within the disposal container.

[0024] In some embodiments or aspects of this disclosure, the cart may include at least one indicator associated with a storage compartment to indicate whether any of one or more disposal containers has been stored for a pre-selected storage period, such that the radioactive component of the used therapeutic or diagnostic agent has decayed to a pre-selected safety threshold level. The cart may include wheels with wheel locks configured to prevent unauthorized or unintentional movement of the cart. The wheel locks may be electronic locks communicating with a controller. The wheel locks may be mechanical locks with a key or other mechanical locking mechanism. The wheel locks are operably connected to a lockable door such that the wheels are unlocked and can only roll after the lockable door is unlocked.

[0025] In some embodiments or aspects of this disclosure, methods for manufacturing and dispensing therapeutic or diagnostic agents are provided. The method may include: filling a vessel with the therapeutic or diagnostic agent; positioning the vessel within a chamber of a storage device having a housing; closing the storage device such that the housing completely encloses the vessel within the chamber; transporting the storage device to a management facility; opening the door of the storage device using an access mechanism of a delivery system; sterilizing the access port of the vessel using a sterilization mechanism of the delivery system; and accessing the therapeutic or diagnostic agent within the vessel via the access port using the delivery system.

[0026] In some embodiments or aspects of this disclosure, accessing a therapeutic or diagnostic agent may include piercing the access port using a spike attached to a cartridge connected to the storage device. The method may also include reading a label or tag on the storage device to determine at least one of product information, manufacturing information, prescription information, and shipping condition information. The method may further include sterilizing the access port by emitting ultraviolet light or outputting a sterilizing material.

[0027] In some embodiments or aspects of this disclosure, a method for storing and discarding used therapeutic or diagnostic agents is provided. The method may include: collecting a storage device that holds a vessel containing remaining portions of the therapeutic or diagnostic agent, a cassette fluidly connected to the storage device, and an infusion kit for positioning in a disposal container. The method may further include: affixing a label, tag, or other marking to the disposal container to indicate a date of use; positioning the disposal vessel containing the storage device, cassette, and infusion kit in a storage compartment; and indicating that the disposal vessel can be safely discarded after a pre-selected decay period has elapsed. The method may also include reading the label or other marking to determine at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0028] In some embodiments or aspects of this disclosure, a method for delivering a dose of a therapeutic or diagnostic agent is provided. The method may include: inserting the therapeutic or diagnostic agent into a vessel; positioning the vessel within a chamber of a storage device having a housing; closing the door of the storage device such that the housing completely seals the vessel within the chamber to shield it from radiation emitted by the radiopharmaceutical, preventing it from being emitted from the housing used for delivering and storing the radiopharmaceutical; determining a dose of the radiopharmaceutical for a patient based on manufacturing information of the radiopharmaceutical included in the storage device; and unlocking the door of the storage device to open the housing, thereby accessing the radiopharmaceutical within the vessel and injecting the determined dose into the patient.

[0029] In some embodiments or aspects of this disclosure, accessing a therapeutic or diagnostic agent may include piercing the access port of the vessel using a spike attached to a cartridge connected to a storage device. The method may also include reading a label or tag on the storage device to determine at least one of product information, manufacturing information, prescription information, and shipping condition information. The method may further include sterilizing the access port of the vessel. Sterilizing the access port may include emitting ultraviolet light or emitting a sterilizing material.

[0030] Other embodiments or aspects of the systems and methods described herein are detailed in one or more of the following clauses:

[0031] Clause 1. A storage device configured to connect to a delivery system for delivering therapeutic or diagnostic agents, the storage device comprising: a housing having a chamber defined therein; a vessel located within the chamber having a distal end opposite a proximal end, wherein an interior is defined between the distal and proximal ends and configured to receive a therapeutic or diagnostic agent, the proximal end having an access port for accessing the interior; a door associated with the housing, the door being movable relative to the housing between a closed position and an open position, wherein in the closed position, the door covers an opening in the housing to close the chamber of the housing, and wherein in the open position, the door exposes an opening in the housing to access the access port of the vessel; and a support located within the chamber of the housing and in contact with the vessel to secure the vessel relative to the housing such that the access port of the vessel is located at the opening in the housing; wherein the door is movable between the closed and open positions in response to actuation of an access mechanism of the delivery system.

[0032] Clause 2. The storage device according to Clause 1, wherein the support includes a contact element for contacting the distal end of the vessel and a plurality of tabs connected to the contact element and configured to engage the inner surface of the housing to secure the distal end of the vessel relative to the housing.

[0033] Clause 3. The storage device according to Clause 1 or 2 further includes a plurality of ribs located within the cavity of the housing and surrounding the opening, wherein the plurality of ribs are configured to secure the proximal end of the vessel relative to the housing.

[0034] Clause 4. The storage device according to any one of Clauses 1 to 3 further includes a lock for locking the door in one of the open and closed positions.

[0035] Clause 5. The storage device according to any one of Clauses 1 to 4 further includes a door cover connected to the housing, wherein the door cover closes the door within the door cavity.

[0036] Clause 6. The storage device according to any one of Clauses 1 to 5, wherein the door cover includes a door access opening having a seal and a vessel access opening positioned opposite an opening in the housing.

[0037] Clause 7. The storage device as described in Clause 6, wherein the seal may be punctured by the access mechanism of the delivery system.

[0038] Clause 8. The storage device pursuant to any one of Clauses 1 to 7 further includes a label or sign on the housing containing machine-readable, authenticable data, which includes at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0039] Clause 9. The storage device according to any one of Clauses 1 to 8, wherein, when the door is in the open position, the opening in the housing is configured to receive a spike extending into the access port for accessing a therapeutic or diagnostic agent.

[0040] Clause 10. The storage device according to any one of Clauses 1 to 9, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and wherein the housing includes a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0041] Clause 11. A component configured to connect to a delivery system for delivering a therapeutic or diagnostic agent, the component comprising: a storage device containing the therapeutic or diagnostic agent; and a fluid cartridge fluidly connected to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing having a chamber defined therein; a vessel located 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, the door being movable relative to the housing between a closed position and an open position, wherein in the closed position, the door covers an opening in the housing to close the chamber of the housing, and wherein in the open position, the door exposes an opening in the housing to access the access port of the vessel, wherein the fluid cartridge comprises: a spike, a metering device, and a fluid path assembly for fluidly connecting the spike to the metering device; and a housing enclosing the spike, the metering device, and the fluid path assembly, and wherein the storage device and the fluid cartridge are configured to connect to the delivery system such that the door of the storage device is accessible by an access mechanism of the delivery system, and that the metering device and the spike of the fluid cartridge are accessible by a delivery mechanism of the delivery system.

[0042] Clause 12. The component according to Clause 11, wherein, when the door is moved to the open position, the vessel access member of the fluid cartridge can be inserted into the access port of the vessel to fluidly connect the metering device to the vessel via the fluid path kit.

[0043] Clause 13. The component as described in Clause 11 or 12, wherein the fluid path kit includes one or more valves, the one or more valves being operable by the delivery mechanism of the delivery system for regulating the flow rate of fluid through the fluid path element.

[0044] Clause 14. The component according to any one of Clauses 11 to 13, wherein the fluid cartridge is connectable to a saline source.

[0045] Clause 15. The component according to any one of Clauses 11 to 14, wherein the storage device includes a guiding mechanism configured to position the storage device relative to the fluid cartridge in a desired orientation.

[0046] Clause 16. The component according to Clause 15, wherein the guiding mechanism includes one or more geometric features on the storage device, and wherein the one or more geometric features are configured to match one or more corresponding geometric features on the fluid cartridge.

[0047] Clause 17. The component according to any one of Clauses 11 to 16, wherein the outlet of the metering device of the fluid cartridge is configured to be connected to the infusion kit for delivering a dose of therapeutic or diagnostic agent from the vessel to the infusion kit.

[0048] Clause 18. The component pursuant to any one of Clauses 11 to 17 further includes a label or sign on the housing containing machine-readable, authenticable data, which includes at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0049] Clause 19. The component according to any one of Clauses 11 to 18, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and wherein the housing includes a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0050] 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; and a fluid delivery assembly removably connected to the injector, the fluid delivery assembly comprising: a storage device containing the therapeutic or diagnostic agent; and a fluid cartridge fluidly connected to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing having a chamber defined therein; a vessel located 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, the door being accessible via the access mechanism of the injector. The fluid cartridge moves between a closed position and an open position relative to the housing, wherein in the closed position, the door covers an opening in the housing to close the chamber of the housing, and wherein in the open position, the door exposes an opening in the housing to access a vessel's access port, wherein the fluid cartridge includes: a vessel access member, a metering device, and a fluid path kit for fluidly connecting the vessel access member to the metering device; and a housing that closes the vessel access member, the metering device, and the fluid path kit, wherein the metering device and the vessel access member of the fluid cartridge can be accessed by a delivery mechanism of an injector for fluidly connecting the interior of the vessel to the metering device via the fluid path kit.

[0051] Clause 21. The delivery system of Clause 20 further includes an injector controller configured to determine the dose of a therapeutic or diagnostic agent to be drawn from the vessel into the metering device based on machine-readable authentication data on the storage device.

[0052] Clause 22. The delivery system according to Clause 21, wherein the injector controller is further configured to determine the dose of a therapeutic or diagnostic agent to be drawn from the vessel into the metering device based on at least one patient parameter.

[0053] Clause 23. The delivery system as described in Clause 21 or 22, wherein the injector controller is connected to the hospital network system.

[0054] Clause 24. The delivery system according to any one of Clauses 21 to 23, wherein the injector controller includes multiple dosing algorithms for different predefined treatment or diagnostic procedures.

[0055] Clause 25. The delivery system according to any one of Clauses 20 to 24, wherein the fluid path assembly includes one or more valves, the one or more valves being operable by the delivery mechanism of the delivery system for regulating the flow rate of fluid through the fluid path elements.

[0056] Clause 26. The delivery system according to any one of Clauses 20 to 25, wherein the fluid cartridge is connectable to a source of physiological saline.

[0057] Clause 27. The component according to any one of Clauses 20 to 26, wherein the outlet of the metering device of the fluid cartridge is configured to be connected to the infusion kit for delivering a dose of therapeutic or diagnostic agent from the vessel to the infusion kit.

[0058] Clause 28. The component according to any one of Clauses 20 to 27, wherein the storage device is configured to be removably or non-removably connected to the fluid cartridge.

[0059] Clause 29. The delivery system according to any one of Clauses 20 to 28 further includes a label or sign on the casing, the label or sign containing machine-readable, authenticable data, the machine-readable, authenticable data including at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0060] Clause 30. The delivery system according to any one of Clauses 20 to 29, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and wherein the housing includes a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.

[0061] Clause 31. A storage device for managing the storage and disposal of used therapeutic or diagnostic agents, the storage device comprising: a trolley having a storage compartment accessible through a lockable door, the storage compartment being configured to store one or more disposal containers, each disposal container comprising: a storage device including: a housing having a chamber defined therein; a vessel located within the chamber of the housing, the vessel being configured to store radiopharmaceutical therein; a door connected to the housing, the door being movable between an open position and a closed position, wherein, in the closed position, the door completely closes the chamber of the housing; and a fluid cartridge including a vessel access member and a metering device, the storage device being attached to the fluid cartridge such that the vessel access member is inserted into the vessel to fluidly connect the metering device to the vessel, the metering device being connected to an infusion kit for injecting a dose of radiopharmaceutical, wherein the infusion kit, the storage device, and the fluid cartridge are held within the disposal container.

[0062] Clause 32. The storage equipment as described in Clause 31, wherein the trolley includes at least one indicator associated with a storage compartment to indicate whether any of one or more disposal containers has been stored for a pre-selected storage period such that the radioactive components of the used therapeutic or diagnostic agent have decayed to a pre-selected safety threshold level.

[0063] Clause 33. Inventory equipment as described in Clause 31 or 32, wherein the trolley includes wheels with wheel locks configured to prevent unauthorized movement of the trolley.

[0064] Clause 34. The stock equipment as described in Clause 33, wherein the wheel lock is an electronic lock that communicates with the controller.

[0065] Clause 35. Inventory equipment as described in Clause 33 or 34, wherein the wheel lock is a mechanical lock having a key or other mechanical locking mechanism.

[0066] Clause 36. The stock equipment according to any one of Clauses 33 to 35, wherein the wheel lock is operably connected to a lockable door such that the wheel is unlocked and can roll only after the lockable door has been unlocked.

[0067] Clause 37. A method for manufacturing and dispensing a therapeutic or diagnostic agent, the method comprising: filling a vessel with the therapeutic or diagnostic agent; positioning the vessel within a chamber of a storage device having a housing; closing the storage device such that the housing completely encloses the vessel within the chamber; transporting the storage device to a management facility; opening the door of the storage device using an access mechanism of a delivery system; sterilizing the access port of the vessel using a sterilization mechanism of the delivery system; and accessing the therapeutic or diagnostic agent within the vessel via the access port using the delivery system.

[0068] Clause 38. The method according to Clause 37, wherein accessing the therapeutic or diagnostic agent includes piercing the access port using a vessel access member connected to a box of the storage device.

[0069] Clause 39. The method described under Clause 37 or 38 further includes reading a tag or label on the storage device to determine at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0070] Clause 40. The method according to any one of Clauses 37 to 39, wherein disinfecting the access port includes emitting ultraviolet light or outputting disinfecting material.

[0071] Clause 41. A method for storing and discarding used therapeutic or diagnostic agents, the method comprising: collecting a storage device, the storage device holding a vessel containing a remaining portion of the therapeutic or diagnostic agent, a cassette fluidly connected to the storage device, and an infusion kit, for positioning in a disposal container; affixing a label, tag, or other marking to the disposal container to indicate the date of use; positioning the disposal container, containing the storage device, cassette, and infusion kit, in a storage compartment; and indicating that the disposal container may be safely discarded after a pre-selected decay period has elapsed.

[0072] Clause 42. The method described in Clause 41 further includes reading labels, tags or other markings to determine at least one of product information, manufacturing information, prescription information and shipping condition information.

[0073] Article 43. A method for delivering a dose of a therapeutic or diagnostic agent, the method comprising: inserting the therapeutic or diagnostic agent into a vessel; positioning the vessel within a chamber of a storage device having a housing; closing the door of the storage device such that the housing completely seals the vessel within the chamber to shield it from radiation emitted by the radiopharmaceutical, preventing it from being emitted from the housing used for delivering and storing the radiopharmaceutical; determining a dose of the radiopharmaceutical for a patient based on manufacturing information of the radiopharmaceutical included in the storage device; and unlocking the door of the storage device to open the housing, thereby accessing the radiopharmaceutical within the vessel and injecting the determined dose into the patient.

[0074] Clause 44. The method according to Clause 43, wherein accessing the therapeutic or diagnostic agent includes piercing the access port using a vessel access member connected to a box of the storage device.

[0075] Clause 45. The method described under Clause 43 or 44 further includes reading a tag or label on the storage device to identify at least one of product information, manufacturing information, prescription information, and shipping condition information.

[0076] Clause 46. The method according to any one of Clauses 43 to 45 further includes sterilizing the inlet port of the vessel.

[0077] Clause 47. The method described in Clause 46, wherein disinfecting the access port includes emitting ultraviolet light or outputting disinfecting material.

[0078] Clause 48. A storage device configured to be connected to a delivery system, the storage device comprising: a housing having a chamber defined therein; a vessel located within the chamber, the vessel containing a radiopharmaceutical therein, wherein the radiopharmaceutical is a free metal cation of the alkaline earth metal radium-223 effective for treatment or prevention; a door associated with the housing, the door being movable relative to the housing between a closed position and an open position, wherein in the closed position, the door covers an opening in the housing to close the chamber of the housing, and wherein in the open position, the door exposes an opening in the housing to access a port of the vessel; and a support located within the chamber of the housing and in contact with the vessel to secure the vessel relative to the housing such that the access port of the vessel is located at the opening in the housing; wherein the door is movable between the closed position and the open position in response to actuation of an access mechanism of the delivery system.

[0079] Clause 49. An assembly configured to connect to a delivery system for delivering radiopharmaceuticals, the assembly comprising: a storage device containing a therapeutic or diagnostic agent; and a fluid cartridge fluidly connected to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing having a chamber defined therein; a vessel located within the chamber, the vessel containing the radiopharmaceutical therein, wherein the radiopharmaceutical is a therapeutic or prophylactic effective amount of a free metal cation of the alkaline earth metal radium-223; and a door associated with the housing, the door being movable relative to the housing between a closed position and an open position, wherein, in the closed position... The door covers an opening in the housing to close the chamber of the housing, and in the open position, the door exposes an opening in the housing to access a vessel's access port, wherein the fluid cartridge includes: a vessel access member, a metering device, and a fluid path kit for fluidly connecting the vessel access member to the metering device; and a housing that closes the vessel access member, the metering device, and the fluid path kit, and wherein a storage device and the fluid cartridge are configured to be connected to a delivery system such that the door of the storage device is accessible by an access mechanism of the delivery system, and that the metering device of the vessel access member and the fluid cartridge is accessible by a delivery mechanism of the delivery system.

[0080] Clause 50. A delivery system for delivering therapeutic or diagnostic agents, the delivery system comprising: an injector having a delivery mechanism and an access mechanism; and a fluid delivery assembly removably connected to the injector, the fluid delivery assembly comprising: a storage device containing the therapeutic or diagnostic agent; and a fluid cartridge fluidly connected to the storage device for accessing the therapeutic or diagnostic agent, wherein the storage device comprises: a housing having a chamber defined therein; a vessel located within the chamber of the housing, the vessel containing a radiopharmaceutical therein, wherein the radiopharmaceutical is a therapeutically or preventively effective amount of the alkaline earth metal radium-223 free metal cation; and a door associated with the housing, the door being movable relative to the housing between a closed position and an open position via the access mechanism of the injector, wherein, in the closed position, the door covers an opening in the housing to close the chamber of the housing, and wherein, In the open position, the door exposes an opening in the housing for access to a vessel, wherein the fluid cartridge includes: a vessel access component, a metering device, and a fluid path kit for fluidly connecting the vessel access component to the metering device; and a housing that closes the vessel access component, the metering device, and the fluid path kit, wherein the vessel access component and the metering device of the fluid cartridge are accessible by a delivery mechanism of an injector for fluidly connecting the interior of the vessel to the metering device via the fluid path kit, wherein the injector includes an injector controller configured to determine the dose of the radiopharmaceutical based on manufacturing data attached to the housing of the storage device, the injector controller being communicatively connected to the injector to control the injector for the injection dose, such that the injection dose received by the patient is the dose determined by the injector controller based on the manufacturing data attached to the housing of the storage device.

[0081] Clause 51. A storage device for managing the storage and disposal of used radiopharmaceuticals, the storage device comprising: a trolley having shelves accessible through a lockable door, the shelves configured to store disposal containers, each disposal container comprising: a storage device including: a housing having a chamber defined therein; a vessel located within the chamber of the housing, the vessel configured to store radiopharmaceuticals therein; a door connected to the housing, the door being movable between an open position and a closed position, wherein, in the closed position, the door completely closes the chamber of the housing; and a fluid cartridge including a vessel access member and a metering device, the storage device being fixed to the fluid cartridge such that the vessel access member is inserted into the vessel to fluidly connect the metering device to the vessel, the metering device being connected to an infusion kit for injecting a dose of radiopharmaceuticals, wherein the infusion kit, the storage device, and the fluid cartridge are held within the disposal container, wherein the trolley includes indicators for the shelves to indicate which disposal containers have been stored for a preselected storage period such that the radiopharmaceuticals have decayed, such that the radioactivity of the material is at or below a preselected safety threshold level.

[0082] Clause 52. A method for manufacturing and dispensing radiopharmaceuticals for targeted radionuclide therapy or diagnostic imaging services, the method comprising: filling a vessel with a radiopharmaceutical for TRT or diagnostic imaging services, wherein the radiopharmaceutical is a therapeutic or preventative effective amount of free metal cation of alkaline earth metal radium-223; positioning the vessel within a chamber of a storage device having a housing; closing the storage device such that the housing completely encloses the vessel within the chamber; transporting the storage device to a management facility; opening the door of the storage device using an access mechanism of a delivery system; sterilizing the access port of the vessel using a sterilization mechanism of the delivery system; and accessing the radiopharmaceutical within the vessel through the access port using the delivery system.

[0083] Clause 53. A method for storing and discarding radiopharmaceuticals used in targeted radionuclide therapy or diagnostic imaging services, the method comprising: collecting a storage device, the storage device holding a vessel containing the remaining portion of the radiopharmaceutical, a cassette connected to the storage device, and an infusion kit, for positioning in a disposal container; placing a label, tag, or other marking on the disposal container to indicate the date of use; positioning the disposal container, containing the storage device, cassette, and infusion kit, in a storage compartment; and indicating that the disposal container may be safely discarded after a pre-selected decay period has elapsed, wherein the radiopharmaceutical is a therapeutic or preventative amount of free metal cations of alkaline earth metal radium-223.

[0084] Clause 54. A method for administering a dose of targeted radionuclide therapy or diagnostic imaging service, the method comprising: inserting a radiopharmaceutical into a vessel, wherein the radiopharmaceutical is a free metal cation of alkaline earth metal radium-223 that is effective for treatment or prevention; positioning the vessel within a chamber of a storage device having a housing; closing the door of the storage device such that the housing completely seals the vessel within the chamber to shield radiation emitted by the radiopharmaceutical from being emitted out of the housing used for delivering and storing the radiopharmaceutical; determining a dose of the radiopharmaceutical for a patient based on manufacturing information of the radiopharmaceutical included in the storage device; and unlocking the door of the storage device to open the housing, thereby accessing the radiopharmaceutical within the vessel and administering the determined dose to the patient.

[0085] Clause 55. A radiopharmaceutical dosing system for administering an effective amount of free metal cations of radium-223 for the treatment or prevention, pursuant to any of the preceding clauses.

[0086] Clause 56. A storage device for managing, storing and disposing of therapeutic or preventative amounts of free metal cations of radium-223, pursuant to any of the preceding clauses.

[0087] Clause 57. The method according to any of the preceding clauses further includes a therapeutic or preventative amount of free metal cations of radium-223. Attached Figure Description

[0088] Figure 1 This is a representative schematic diagram of the conventional supply chain for configuring radiotherapy agents for TRT based on existing technology;

[0089] Figure 2 This is a representative schematic diagram of a conventional method for applying TRT based on existing technology;

[0090] Figure 3 This is a representative schematic diagram of an improved supply chain for radiotherapy agents used in TRT, configured according to some embodiments or aspects of this disclosure;

[0091] Figure 4 These are representative schematic diagrams of an improved method for applying TRT according to some embodiments or aspects of this disclosure;

[0092] Figure 5 A perspective view of a system for dispensing, applying, and discarding liquid products that require precise volume delivery from a controlled source, according to some embodiments or aspects of this disclosure;

[0093] Figure 6 A perspective view of a system for dispensing, applying, and discarding liquid products that require precise volume delivery from a controlled source, according to some embodiments or aspects of this disclosure;

[0094] Figure 7 A perspective view of a storage device for storing liquid products (such as radiotherapy agents) according to some embodiments or aspects of this disclosure;

[0095] Figure 8 for Figure 7 Cross-sectional perspective view of the storage device shown;

[0096] Figure 9 for Figure 7 An exploded top perspective view of the storage device shown.

[0097] Figure 10 It is a cross-sectional perspective view showing a storage device with a first vessel;

[0098] Figure 11 It is a cross-sectional perspective view showing a storage device with a second vessel;

[0099] 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 this disclosure;

[0100] Figure 13-14 A detailed view of a locking mechanism for preventing reuse of a storage device according to some embodiments or aspects of this disclosure;

[0101] Figure 15 This is a perspective view of a storage device for storing liquid products (such as radiotherapy agents) according to some embodiments or aspects of this disclosure;

[0102] Figure 16 yes Figure 15 Side view of the storage device shown;

[0103] Figures 17A-17B This shows a bottom perspective view of a storage device according to some embodiments or aspects of this disclosure;

[0104] Figure 18 yes Figure 15 An exploded perspective view of the storage device shown.

[0105] Figure 19 yes Figure 15 Cross-sectional perspective view of the storage device shown;

[0106] Figure 20 This is a perspective view of a storage device and a fluid cartridge for administering a dose from the storage device, according to some embodiments or aspects of this disclosure;

[0107] Figure 21 yes Figure 20 A perspective view of the fluid cell shown;

[0108] Figure 22 yes Figure 21 An exploded perspective view of the fluid cell shown.

[0109] Figure 23 This is a perspective view of a vessel access member configured to pierce a storage device according to some embodiments or aspects of this disclosure;

[0110] Figure 24 This is a detailed perspective view of the metering device connection interface of a fluid cartridge according to some embodiments or aspects of this disclosure;

[0111] Figure 25A This is a perspective view showing the plunger cap in the unlocked position;

[0112] Figure 25B It indicates that it is in the locked position. Figure 25A A perspective view of the plunger cap;

[0113] Figure 26 This is a perspective view of a fluid cartridge and components of a delivery system configured to interact with the fluid cartridge, according to some embodiments or aspects of this disclosure.

[0114] Figure 27 This is a perspective view of a storage device and a fluid cartridge for administering a dose from the storage device, according to some embodiments or aspects of this disclosure;

[0115] Figure 28 yes Figure 27 A detailed view of the connection between the storage device and the fluid cartridge shown;

[0116] Figure 29 yes Figure 28 A perspective view of the fluid chamber shown;

[0117] Figure 30 yes Figure 29 An exploded perspective view of the fluid cell shown;

[0118] Figure 31 This is a schematic diagram of the fluid connection between the container, fluid cartridge, and patient delivery line of a storage device according to some embodiments or aspects of this disclosure;

[0119] Figure 32 This is a perspective view of a fluid cartridge and storage device according to some embodiments or aspects of this disclosure, and components of an infusion system configured to interact with the fluid cartridge and storage device;

[0120] Figure 33 yes Figure 32 A perspective view of the components of the infusion system shown;

[0121] Figure 34 This is a perspective view of a disinfection system for disinfecting a portion of a storage device according to some embodiments or aspects of this disclosure;

[0122] Figure 35 This is a perspective view of a carrier tray for transporting multiple storage devices according to some embodiments or aspects of this disclosure;

[0123] Figure 36 This is a perspective view of a disposal container for disposal storage devices and boxes according to some embodiments or aspects of this disclosure;

[0124] Figure 37 This is a schematic diagram of a storage housing for storing multiple discard containers according to some embodiments or aspects of this disclosure;

[0125] Figure 38 This is a flowchart of a fluency check procedure based on some embodiments or aspects of this disclosure; and

[0126] Figure 39 This is a flowchart of the application procedure for using the system described according to some embodiments or aspects of this disclosure.

[0127] exist Figure 1-39 In this context, the same characters refer to the same parts and components, as the case may be, unless otherwise specified. Detailed Implementation

[0128] As used in this article, the singular forms of “a,” “one,” and “the” include plural objects unless the context clearly specifies otherwise.

[0129] Spatial or directional terms, such as “left,” “right,” “inner,” “outer,” “up,” “down,” etc., are related to the embodiments or aspects shown in the accompanying drawings and should not be considered limiting, as various alternative orientations may be adopted for the embodiments or aspects.

[0130] All figures used in the specification and claims should be understood to be modified by the term "about" in all cases. "About" means plus or minus 25% of the value, for example, plus or minus 10% of the value. However, this should not be considered a limitation on any numerical analysis under the principle of equivalence.

[0131] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to encompass the starting and ending values, as well as any and all subranges or subratios contained therein. For example, the specified range or ratio “1 to 10” should be considered to include any and all subranges or subratios between the minimum value of 1 and the maximum value of 10 (inclusive); that is, all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average of a particular range and / or ratio.

[0132] The terms “first” and “second” do not refer to any specific order or sequence, but rather to different conditions, attributes, or elements.

[0133] All documents cited in this article are incorporated by reference in their entirety.

[0134] The term "at least" is synonymous with "greater than or equal to".

[0135] The term "not greater than" is synonymous with "less than or equal to".

[0136] This document may describe some non-limiting embodiments or aspects in conjunction with thresholds. As used herein, satisfying a threshold may refer to a value greater than a threshold, more than a threshold, higher than a threshold, greater than or equal to a threshold, less than a threshold, less than a threshold, lower than a threshold, less than or equal to a threshold, equal to a threshold, etc.

[0137] As used herein, “at least one” is synonymous with “one or more”. For example, the phrase “at least one of A, B or C” means any one of A, B or C, or any combination of any two or more of A, B or C. For example, “at least one of A, B or C” includes only A; or only B; or only C; or A and B; or A and C; or B and C; or all of A, B and C.

[0138] The terms "include" and "contain" are synonymous.

[0139] When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, or fluid line), the term "distal" refers to the portion of the component closest to the patient. When used relative to a component of an injector system (such as a fluid reservoir, syringe, or fluid line), the term "proximal" refers to the portion of the component closest to the injector of the injector system (i.e., the portion of the component furthest from the patient). When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, or fluid line), the term "upstream" refers to the direction relative to the normal fluid flow of the injector system, away from the patient and towards the injector. When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, or fluid line), the term "downstream" refers to the direction relative to the normal fluid flow of the fluid delivery system, towards the patient and away from the injector.

[0140] As used herein, the terms “communication” and “transmission” can refer to the receipt, receiving, transmission, transfer, provision and / or similar of information (e.g., data, signals, messages, instructions, commands and / or the like).

[0141] As used herein, the term “radiopharmaceutical” refers to a medicine containing a radionuclide. As described herein, radiopharmaceuticals are preferably formulated for intravenous (iv) administration. There are two types of radiopharmaceuticals: diagnostic (or imaging) and therapeutic radiopharmaceuticals, although in some cases therapeutic radiopharmaceuticals may be used for both. For example, a TRS can emit gamma radiation, which can be used for dose assessment and / or diagnostic purposes. Radiopharmaceuticals commonly used for imaging, such as positron emitters, can also be used for treatment. See, for example, “The Neglected Potential of Positrons in Cancer Therapy,” Hioki, T., Gholami, YH, McKelvey, KJ, et al., Scientific Reports 11, 2475 (2021).

[0142] As used herein, the terms "diagnostic radiopharmaceutical" or "imaging radiopharmaceutical" include gamma-emitting imaging radiopharmaceuticals used for SPECT or SPECT / CT imaging and / or positron-emitting imaging radiopharmaceuticals used for PET or PET / CT imaging. Examples of gamma-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).

[0143] The term “therapeutic radiopharmaceutical” as used in this article includes beta therapeutic radiopharmaceuticals, alpha therapeutic radiopharmaceuticals, positron-emitting radiopharmaceuticals, Auger therapeutic radiopharmaceuticals, gamma therapeutic radiopharmaceuticals and / or combinations thereof.

[0144] As used herein, the term "therapeutic or diagnostic agent" means any diagnostic drug, imaging drug, radiotherapy or chemotherapy drug, therapeutic drug, or any other liquid or powder (once reconstituted) for therapeutic or diagnostic purposes that requires precise dose delivery from a controlled source, wherein the dose is the amount of the active ingredient. Dose delivery can be accomplished through precise volumetric delivery.

[0145] All radiation shielding is partial or localized. Increasing the thickness of a half-value layer on the shield can reduce transmitted radiation by half. The effectiveness of shielding depends on the energy of the radiation being shielded. Therefore, terms such as “block,” “stop,” or “prevent” radiation transmission or emission indicate that the transmitted or emitted radiation has been reduced to an acceptable level. This acceptable level may depend on local regulations, requirements, policies, or preferences. Many of the materials used for shielding and the guidelines involved are well known to those skilled in the art of health physics.

[0146] This disclosure includes, consists of, or substantially consists of examples of the following embodiments or aspects in any combination. Various examples of this disclosure may be discussed individually. However, it should be understood that this is merely for the purpose of illustration and discussion. In practice, 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 other examples.

[0147] In various embodiments or aspects, this disclosure relates to systems and methods for the dispensing, storage, administration, and disposal of radiopharmaceutical therapeutic agents. This disclosure also relates to systems and methods for the dispensing, storage, administration, and disposal of other therapeutic or diagnostic agents that require precise volumetric delivery from a controlled source, such as chemotherapy drugs. As discussed herein, conventional methods for dispensing and administering therapeutic or diagnostic agents require precise volumetric delivery from a controlled source, which severely limits their applicability and use. After considering transportation, processing, and patient scheduling, the time available at treatment sites to administer doses to specific patients is limited. The systems and methods described herein provide improvements in the dispensing, storage, administration, and disposal of therapeutic or diagnostic agents to allow for increased time to administer doses to specific patients.

[0148] As described in various embodiments or aspects of this disclosure, storage devices may be configured to store radiotherapy agents from a production site for transport and storage in a treatment facility, thus ensuring the radiotherapy agents are fully sealed and encapsulated before use. The size, shape, and construction of each storage device may provide radiation shielding suitable for the stored radioisotopes and doses. Storage devices may also be further encapsulated and surrounded by additional shielding. As described herein, the storage device housing is configured to be opened and unsealed only at the treatment location using specialized equipment. In some embodiments or aspects, storage devices may be configured to store therapeutic or diagnostic agents other than radiopharmaceuticals from a production site for transport and storage in a treatment facility, thus ensuring the therapeutic or diagnostic agents are fully sealed and encapsulated before use.

[0149] As described in various embodiments or aspects of this disclosure, a system comprising a radiotherapy agent injection / infusion system is provided. This system is particularly suitable for accessing therapeutic or diagnostic agents stored in a storage device, thus allowing material to be administered to a patient only through the injection / infusion system; otherwise, administration can be prevented if the storage device is not identified as an authentic storage device. The storage device can be configured such that only the injection / infusion system can open the storage device to access the therapeutic or diagnostic agent for injection into a patient. When the therapeutic or diagnostic agent is a radiopharmaceutical, the combination of the storage device and the injection / infusion system helps ensure that the radioactive material remains completely sealed and closed from production to use. Furthermore, the injection / infusion system and the storage device can remain connected and unopenable once in use to facilitate the safe containment and disposal of radioactive waste after use.

[0150] As described in various embodiments or aspects of this disclosure, a system and method may be provided for calculating a dose for a specific patient based on the therapeutic or diagnostic agent being administered, patient parameters (such as patient weight), known manufacturing and / or calibration dates, known radioactivity or other properties of the therapeutic or diagnostic agent at the time of manufacture, and a known current date and time, to determine a suitable dose for injecting a volume of the therapeutic or diagnostic agent corresponding to the calculated active dose into the patient for treatment. When the therapeutic or diagnostic agent is a radiopharmaceutical, unused portions of the radiopharmaceutical and other potentially contaminated components that came into contact with the radiopharmaceutical may be stored in a disposal container for storage until the radioactivity decreases 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 are configured to ensure dosing consistency as each patient receives the desired amount of therapeutic or diagnostic agent.

[0151] 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 or required to be for patient use only. Instead, the systems disclosed herein are configured to treat any patient who may be at that location on any given day, providing greater flexibility in how stored products are used at the treatment location, thereby enabling the delivery of an effective dose of radiopharmaceutical to the patient. This patient-specific dosing can be accomplished without a dosimeter, eliminating the need for additional dosimetry to prepare a patient-ready dose.

[0152] As described in various embodiments or aspects of this disclosure, a system and method may be provided to monitor therapeutic or diagnostic agents stored in a disposal container and indicate when the stored material has sufficiently decayed and is safe to discard. Once this decision is made, an instruction may be provided to the user (e.g., a software prompt, or an LED light that can change from red to green, or a red LED that can be turned off and a green LED that can be turned on), so that staff can identify suitable material for disposal, locate the material to be discarded, and discard the material appropriately.

[0153] As described in various embodiments or aspects of this disclosure, the improved inventory management flexibility associated with the systems and methods described herein allows care providers to manage inventory more effectively, eliminating the need for a simple first-in-first-out approach and / or a method requiring each stored dose to be delivered only to a single, specific patient. Instead, inventory management and dose usage are tailored to consider various factors, including patient needs, to better manage the supply of available doses. For example, if a particular patient requires a larger dose due to the patient's body type (e.g., weight, height and weight, body composition, etc.), a newer, more radioactive therapeutic vial can be selected for administration, requiring only one vial (instead of multiple vials) to deliver the dose to the patient. This can allow for simpler administration (e.g., using only one injection sequence) and greater flexibility in inventory management and administration, resulting in more efficient dose utilization and less waste. In some cases, this type of flexibility can also help reduce clinician exposure during treatment administration and minimize subsequent cleanup procedures after a patient has received his or her dose.

[0154] Figure 3An improved supply chain for therapeutic or diagnostic agents according to some embodiments or aspects of this disclosure is illustrated. The therapeutic or diagnostic agents can be mass-produced in a manufacturing facility. Instead of loading the therapeutic or diagnostic agents into bulk containers and transporting them to a thermal laboratory, they are loaded into storage devices that are transported directly to the treatment site. The storage devices are configured to store the therapeutic or diagnostic agents from the point of production during transport and during storage at the treatment facility. As described herein, the therapeutic or diagnostic agents are configured to be administered directly to the patient from the storage devices using a delivery system. The dose for each specific patient is determined by the delivery system, rather than using a dose calibrator.

[0155] like Figure 4 As shown, the method of diagnosing, referring, and treating patients based on an improved supply chain eliminates multiple steps compared to conventional methods. After diagnosing patient P and prescribing a dose of therapeutic or diagnostic agent based on the patient's weight, the dose can be administered directly from storage device 200 loaded into delivery system 100 using delivery system 100. Prescribing and administration can be performed by the same authorized user AU.

[0156] refer to Figure 5 According to some embodiments or aspects of this disclosure, a delivery system 100 for dispensing, administering, and discarding therapeutic or diagnostic agents is shown. As described herein, system 100 includes multiple components designed to work together to provide safe, streamlined, and flexible dispensing of therapeutic or diagnostic agents. Delivery system 100 is also configured to assist end users in maintaining and managing inventory of therapeutic or diagnostic agents.

[0157] In some embodiments or aspects, delivery system 100 may be configured to store, administer, and discard therapeutic or diagnostic agents, such as radiopharmaceutical therapeutics or diagnostics. Radiopharmaceutical therapeutics or diagnostics that can be stored and injected into a patient may be substances in a fluid. Radiopharmaceuticals may primarily emit alpha radiation or may primarily emit beta radiation. In some embodiments or aspects, radiopharmaceuticals may primarily emit Auger radiation or positron radiation, and thus emit secondary gamma radiation. As described herein, for materials that may primarily emit beta radiation, storage device 200 and delivery system 100 may be adapted to handle secondary X-ray radiation that may be emitted due to shielding against beta radiation. Delivery system 100 may be adapted to handle gamma radiation additionally emitted by the radiopharmaceutical. In some examples or aspects, delivery system 100 may be configured for the storage, administration, and disposal of XOFIGO® treatments and other TRT treatments that may utilize targeted alpha or targeted beta therapy. The delivery system 100 can also be configured for use with radioactive isotopes (e.g., radioactive isotopes with very short half-lives, such as technetium-99 or copper-64, which can be used for imaging or other purposes) that can be manufactured at the treatment site for therapeutic or diagnostic services.

[0158] In some embodiments or aspects, the delivery system 100 may be configured to store, administer, and discard therapeutic or diagnostic agents, such as imaging radiopharmaceuticals, as radiopharmaceuticals. In some embodiments or aspects, the imaging radiopharmaceutical may be a gamma-emitting imaging radiopharmaceutical. Gamma-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.

[0159] In some embodiments or aspects, the delivery system 100 may be configured to store, administer, and discard therapeutic or diagnostic agents, such as therapeutic radiopharmaceuticals, as radiopharmaceuticals. In some embodiments or aspects, the therapeutic radiopharmaceutical may be a beta therapeutic radiopharmaceutical. Beta 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 therapeutic radiopharmaceutical. Alpha therapeutic radiopharmaceuticals include, but are not limited to, radium-223, actinium-225, thorium-227, astatine-211, lead-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, 223Radichloride, 18F-Fluciclovine, 123I-Ioflupane, 68Ga-Dotatate, 111In, 99mTc-Tilmanocept, 99mTc-tetrofosmin, 18F-Florbetaben, 99mTc, 90Y-Ibritumomab tiuxetan, 18F-Florbetapir, 153Sm-Lexidronam EDTMP, 131I-Iobenguane MIBG and / or 89Sr-Chloride. In some embodiments or aspects, the radionuclides configured for imaging or therapeutic purposes are associated with FAP (fibroblast activating protein), PSMA (prostate-specific membrane antigen), DOTA (dodecanetetraacetic acid and its chelate derivatives), HER2 (human epidermal growth factor receptor 2), GPC-3 (glycosylphosphatidylinositol proteoglycan-3 protein), or other drugs with a radiopharmaceutical mechanism of action.

[0160] In some embodiments or aspects, the delivery system 100 may be configured to work with radioisotopes that can be used for imaging or other purposes (e.g., radioisotopes with very short half-lives, such as technetium-99m, nitrogen-13, fluorine-18, gallium-68, or copper-64), which may be prepared at the treatment site for therapeutic or diagnostic services. These types of radioisotopes tend to have very short half-lives, requiring the imaging provider to prepare the radioisotopes in a field thermal laboratory or central radiopharmacy for efficient use in diagnostic services. For such applications, the provider can prepare diagnostic service materials on-site. The provider can then insert the material into a vial, place the vial in a storage device, and record and label the storage device to indicate its production date, fluid volume, concentration, and / or initial radioactivity. 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 cartridges, injectors, and infusion kits as described herein to deliver a defined dose to the patient prior to imaging. Used materials can also be stored in a similar manner for disposal, as described in this article.

[0161] The various components of the delivery system 100 are described in detail below, and how these components allow for improved dispensing, administration, and disposal of therapeutic or diagnostic agents using the delivery system 100.

[0162] Continue to refer to Figure 5This illustration shows a delivery system 100 according to one embodiment or aspect of this disclosure. The delivery system 100 can be configured as a mobile device. The delivery system 100 includes a trolley 102 supported on wheels 104 for moving the trolley 102. In some embodiments or aspects, the delivery system 100 can be fixedly mounted. The trolley 102 includes a plurality of storage components 106, such as shelves or drawers for storing various components of the delivery system 100. In some embodiments or aspects, the storage component 106 includes a first drawer or shelf 108 for storing one or more storage devices 200 prior to use. The first drawer 108 may include the ability to keep the storage container 200 at a low temperature to meet the requirements of the stored medication. The first drawer or shelf 108 may be further configured to store infusion kits and other fluid pathway components for connecting the delivery system 100 to a patient during administration of a therapeutic or diagnostic agent. The storage component 106 may include a second drawer or shelf 110 configured to receive components of the delivery system 100 for administration of a therapeutic or diagnostic agent. For example, the second drawer or shelf 110 may be configured to receive one or more components 150 for administering a dose of a therapeutic or diagnostic agent. As described herein, each component 150 includes a single storage device 200 connected to a single-use fluid cartridge 300. In some embodiments or aspects, component 150 may include one or more reusable storage devices 200 and reusable fluid cartridges 300. Each component 150 is removably inserted into the second drawer or shelf 110. Component 150 is operatively connected to an injector 170 for delivering a dose of a therapeutic or diagnostic agent. Component 150 may be configured for single-use by a single patient. In some embodiments or aspects, component 150 may be configured for use by multiple patients.

[0163] The delivery system 100 also includes a third drawer or shelf 112 configured to store one or more used components 150. Each component is configured to minimize handling of the storage device 200 in the workflow. At least one of the first, second, and third drawers or shelves 108, 110, 112 may have radiation shielding material to sufficiently reduce radiation or radioactivity outside the trolley 102.

[0164] Further reference Figure 5The delivery system 100 also includes a controller 114 for controlling the dosing delivery of therapeutic or diagnostic agents. The controller 114 may be connected to one or more user displays 116 for displaying information related to the storage, administration, and / or disposal of the therapeutic or diagnostic agents. In some embodiments or aspects, the display 116 is a touchscreen display capable of being controlled via touch commands received from a user. The controller 114 may also be connected to an input device 118 for inputting data related to the storage, administration, and / or disposal of the therapeutic or diagnostic agents. In some embodiments or aspects, the input device 118 may be a barcode scanner, keyboard, mouse, touchscreen display, and / or any other input mechanism for inputting data and / or commands related to the operation of the delivery system 100 to the controller 114. The input device 118 may include video conferencing capabilities. The controller 114 may be further connected to a camera 117. The camera may be used to provide input to the controller, such as reading machine-readable or human-readable labels or signs. The camera may be used to photograph, record, and / or transmit anything in progress for use by field operators, off-site operators, or for training or archiving purposes. In some embodiments or aspects, an output device 119, such as a printer, is provided. Printer 119 can be used to print labels for documents, labels placed on trash cans, patient travel cards, patient reminders, and / or patient guides.

[0165] Controller 114 may include at least one processor programmed or configured to calculate a 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 in controller 118 may also be configured to actuate various components of delivery system 100 to deliver a dose to a patient according to a programming scheme for an injection procedure. Controller 118 may include a computer-readable medium, such as memory, on which one or more injection schemes may be stored for execution by at least one processor.

[0166] The controller 114 of the delivery system 100 is adapted to determine the dose of a therapeutic or diagnostic agent to be delivered to a patient. The dose can be determined by one or more variables, which can be provided to the controller 114 via one or more input devices 118. For example, patient weight or other patient characteristics can be input via a keyboard and / or mouse. The range of radiopharmaceutical activity of the therapeutic or diagnostic agent can be determined by the controller 114 based on information associated with a label or tag 270, for example, attached to... Figure 16The storage device 200 shown may have a machine-readable tag (e.g., a barcode) or electronic tag (e.g., RFID). In some embodiments or aspects, the information associated with the tag or label 270 may include manufacturing information and / or radioactivity information (e.g., manufacturing date, calibration date and time, radioactivity at calibration, radioactivity level of materials at manufacturing time, fluid volume, fluid concentration, type of radioactive isotope, etc.). In further embodiments or aspects, the information associated with the tag or label 270 may include historical values ​​of time and temperature of the storage device 200 during transport and handling. This information, along with the current date or time, may be used by the controller 114 to determine an appropriate dose for the patient using a predefined dosing algorithm that can utilize these parameters. Some predefined dosing algorithms may also use additional parameters, such as the patient's weight, the patient's sex, and / or the patient's age. Some predefined dosing algorithms may also use additional parameters, such as a prescribed dose and a prescribed or targeted tissue dose.

[0167] In some embodiments or aspects, controller 118 may have different dosing algorithms for different predefined treatments. Scanned barcodes, read RFID tags, and / or other user-provided inputs can be used to select the appropriate dosing algorithm to run in order to determine the patient's dose.

[0168] Continue to refer to Figure 5 Each storage compartment 106 can be locked and configured for access by an authorized user with an appropriate access scheme. For example, each storage compartment 106 may have a lock 120 operatively connected to the controller 114. Operation of the lock 120 may require authenticating an authorized user of the delivery system 100 by entering a password or other authentication means, such as using a display 116 or an input device 118.

[0169] Continue to refer to Figure 5One or more wheels 104 of the trolley 102 may have wheel locks 122 for selectively locking the wheels 104 to prevent movement of the trolley 102. Wheel locks 122 may be configured to prevent unauthorized movement of the trolley 102. For example, wheel locks 122 may be operatively connected to a controller 114. Operation of wheel locks 122 may require authentication of an authorized user of the delivery system 100 using, for example, a display 116 or input device 118 to enter a password or other authentication means to allow movement of the wheels 104. Wheel locks 122 may be keyed mechanical locks or other mechanical locking mechanisms. In some embodiments or aspects, wheel locks 122 may be operatively connected to locks 120 of storage compartment 106 such that operation of one of wheel locks 122 and locks 120 also controls operation of the other of wheel locks 122 and locks 120. In some embodiments or aspects, an alarm system may be operatively connected to at least one of locks 120 and wheel locks 122 such that an alarm may sound or provide an alarm message in response to unauthorized use of the delivery system 100. In some embodiments or aspects, an alarm system may be configured to prevent operation of the delivery system 100 and / or movement of the cart 102, for example by locking the wheel locks 122. The cart 102 may also include a compartment for storing auxiliary devices 113, which, while not directly used in the infusion process, are necessary or useful throughout the procedure. For example, it may contain a measuring instrument or other radiation detector to measure the exterior of the packaging and / or storage container 200 as it is registered into the cart. The measuring instrument may also be used to measure the exterior of the component 150 after the injector to check for leaks. The measuring instrument may also be used to measure any contamination of the patient, operator, and infusion chamber. The auxiliary device compartment 113 may also contain an overflow remediation kit for abnormal situations where an overflow occurs, such as if the IV comes out of the patient's arm during infusion. The auxiliary device compartment may include other items common in thermal laboratories and required for the infusion, as the benefit of the delivery system 100 is to provide the necessary capability and equipment to safely deliver the medication designed to be delivered.

[0170] refer to Figure 6 This illustrates a delivery system 100' according to another embodiment or aspect of this disclosure. Similar to reference... Figure 5 The delivery system 100 shown and described Figure 6 The delivery system 100' shown is configured as a mobile device including a trolley 102' supported on optional wheels. The trolley 102' includes a plurality of storage components 106' for storing one or more storage devices 200 before use, and for storing one or more used components 150.

[0171] Figure 6The delivery system 100' shown does not incorporate the injector 170 into the cart 102, but instead has a separate injector 170' supported on a separate movable base 124. The injector 170' is configured to receive a component 150 including a storage device 200 and a fluid cartridge 300. The delivery system 100' also includes a controller 114' for controlling the delivery of a dose of the therapeutic or diagnostic agent. The controller 114' may be connected to one or more user displays 116' for displaying information related to the storage, administration, and / or disposal of the therapeutic or diagnostic agent. In some embodiments or aspects, the display 116' is a touchscreen display capable of being controlled via touch commands received from a user. The user display 116' may be configured to input data related to the storage, administration, and / or disposal of the therapeutic or diagnostic agent. In some aspects, some communication may be wireless, eliminating the need for a continuous physical connection between selected components. In some aspects of system 100, one or more fixed trolleys 102' and one or more mobile trolleys 102 may communicate with each other to facilitate flexible or optimal storage and use of the materials involved. In busy locations, used components 150 can be moved from mobile trolleys to fixed trolleys, which can provide in-situ storage aids in decay. 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 aids in in-situ decay cabinets may be in different rooms or even different facilities.

[0172] refer to Figure 7-9 Storage device 200 is shown according to one embodiment or aspect of this disclosure. As described herein, storage device 200 is configured to store a quantity of therapeutic or diagnostic agents. In embodiments or aspects where the therapeutic or diagnostic agent is a radiopharmaceutical, storage device 200 is configured to contain radiation emitted by a radioisotope of the radiopharmaceutical.

[0173] refer to Figure 8 The storage device 200 includes a housing 201, within which a chamber 202 is defined. The housing 201 has a body 204 defining the chamber 202. The body 204 has a proximal end 206 with a first opening 208 and a distal end 210 with a second opening 212. A cap 214 is provided to close the second opening 212 at the distal end 210 of the body 204 of the housing 201. In some embodiments or aspects, a gasket or seal 217 is provided at the interface between the cap 214 and the distal end 210 of the body 204. In some embodiments or aspects, the cap 214 is connected via, for example, one or more clips 216 (such as...). Figure 9(As shown) It is non-removably connected to the body 204. 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 of, bonded to or contain a shielding material, such as polymethyl methacrylate (PMMA), lead or tungsten.

[0174] refer to Figure 9 The body 204 has an inner portion 218 and an outer portion 220 defining a chamber 202. The inner portion 218 can be connected to the outer portion 220 via 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 can be an air cavity, or it can be filled with one or more shielding materials, such as PMMA, lead, or tungsten; damping materials, such as polystyrene beads; or absorbent materials, such as paper. The filling material can be formed, for example, from one or more solid sheets, loose forms (e.g., beads or spheres), liquids, or hardened pourable fillers, or combinations thereof. The inner portion 218 and the outer portion 220 can have the same or different shapes. For example, the inner portion 218 can have a substantially cylindrical shape, while the outer portion 220 can have a substantially cuboid shape. The edges of the cuboid-shaped outer portion 220 can be rounded. In some embodiments or aspects, the inner portion 218 and the outer portion 220 can be integrally formed.

[0175] For agents emitting beta radiation, the internal structure of the storage device 200 can be designed and configured to prevent X-rays formed by beta radiation from being emitted from the housing 201. This blocking of beta radiation and X-rays is influenced by the internal structure of the storage device 200, such as the shielding material disposed in the cavity 224. Alternatively or additionally, the sidewalls of the housing 201 can be selected, for example by choosing the thickness and material properties, to prevent the emission of X-rays and beta radiation. In some embodiments or aspects, the storage device 200 may have a plurality of spaced-apart shielding elements (e.g., spaced-apart shielding walls) defined between the outer wall of the chamber 202 and the housing 201. In some configurations, a filler or fluid (e.g., air) can be positioned in the cavity 224 to provide adequate shielding against X-rays and / or beta radiation.

[0176] Alpha radiation is generally not as difficult to block as alpha particles because alpha particles are larger, have more limited penetrating power, and are typically administered at doses lower than beta rays. The sidewalls of the housing 201 can be chosen to have sufficient thickness to shield against alpha radiation. Additional wall thickness or filler can be provided within the cavity 224 to help secure the vessel 226 in the desired location and / or provide additional shielding, as many alpha and beta radioisotopes, or their daughter isotopes, also emit gamma radiation, preventing any additional radiation exposure from the radiopharmaceutical emitted from the housing. The dimensions of the housing 201 relative to the vessel 226 can be chosen to set a minimum distance from the outside of the housing 201 to the vessel 226, thereby reducing user exposure. However, in general, isotopes emit more than one type of radiation, or different energy levels of radiation with varying penetrating power. Furthermore, all isotopes accumulate some daughter products between drug manufacturing and delivery. Therefore, effective gamma shielding may be necessary for those acting as nominal alpha or beta emitters. The materials used for shielding and the guidelines involved are well known to those skilled in the art of health physics.

[0177] refer to Figure 8-9 The chamber 202 of the outer shell 201 is used to contain a vessel 226, which contains a therapeutic or diagnostic agent 228 (such as...). Figure 8 (As shown). 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 integrally formed with the storage device 200. The size of the chamber 202 is chosen to accommodate the largest container 226 that can be used with the storage device 200 and / or to consider any additional packaging or shielding material that may be required.

[0178] The vessel 226 has a proximal end 230 with an access port 232 and a closed distal end 234, defining an interior 236 between the proximal end 230 and the distal end 234. The access port 232 may be a puncturable septum configured to be punctured by a vessel access member or other access mechanism for accessing a therapeutic or diagnostic agent 228 within the interior 236 of the vessel 226, as described herein. During the manufacture of the therapeutic or diagnostic agent 228, the agent 228 may be filled into the vessel 226, and the vessel 226 may subsequently be sealed via the access port 232 to retain the agent 228 therein. Filling of the vessel 226 may be performed after the vessel 226 has been attached or positioned within the chamber 201 of the storage device 200, or before the vessel 226 has been attached or positioned within the chamber 201. In some embodiments or aspects, the access port 232 may be completely sterilized during manufacture. The vessel 226 can also be a plastic vial, flexible capsule, collapsible bag, or pre-filled syringe, preferably with a plunger but without a handle to reduce the required space. One advantage of collapsible vessels and pre-filled syringes is that when fluid is drawn, the vessel folds or the plunger moves downward, so that air is not required to enter the vessel when the fluid is removed.

[0179] refer to Figure 8 The proximal end 230 of the vessel 226 is located at the proximal end 206 of the housing 201, such that the access port 232 is located opposite the first opening 208. In this way, during the administration of the therapeutic or diagnostic agent 228, the vessel access member can extend through the first opening 208 of the housing 201 and through the access port 232 of the vessel 226.

[0180] In some embodiments or aspects, the vessel 226 may be secured to the proximal end 206 of the housing 201 within the chamber 202 of the housing 201 and around the first opening 208 by a plurality of ribs 238. Each of the plurality of ribs 238 may be configured to engage the proximal end 230 of the vessel 226 to secure the position of the access port 232 relative to the first opening 208 of the housing 201.

[0181] refer to Figure 8-9 The storage device 200 has a support 240 within a chamber 202 of the housing 201. The support 240 can be configured to hold the distal end 234 of a vessel 226 relative to the housing 201. The support 240 can contact the distal end 234 of the vessel 226 to fix the position of the vessel 226 relative to the housing 201. In some embodiments or aspects, the support 240 includes a contact element 242 for contacting the distal end 234 of the vessel 226 and a plurality of tabs 244 connected to the contact element 242 and configured to engage the housing 201 (e.g., the inner surface 246 of the inner portion 218 of the housing 201) to fix the position of the vessel 226 relative to the housing 201. Figure 9-10As shown, a plurality of tabs 244 can be angled relative to the contact element 242 such that they are oriented at a non-perpendicular angle relative to the inner surface 246 of the inner portion 218 of the housing 201. The plurality of tabs 244 can be bent relative to the contact element 242 such that when the contact element 242 is pushed against the distal end 234 of the vessel 226, the plurality of tabs 244 provide a restoring force against movement of the support 240 in a direction distal to the distal end 234 of the vessel 226. In this way, the support 240 is configured to hold a plurality of different vessels 226, regardless of their diameter and longitudinal length.

[0182] refer to Figure 8-9 The storage device 200 has a door 248 associated with the housing 201. In some embodiments or aspects, the door 248 may be positioned relative to the housing 201. Figure 8 The door 248 moves between the closed and open positions as shown. As described herein, the door 248 can move between the closed and open positions in response to actuation of the access mechanism of the delivery system 100. In some embodiments or aspects, the door 248 may be normally closed. In the closed position, the door 248 is configured to cover the first opening 208 in the housing 201 to close the chamber 202 of the housing 201. In this way, the vessel 226 is completely enclosed within the chamber 202 and access to the access port 232 is prevented. In the open position, the door 248 moves relative to the housing 201 to expose the first opening 208 in the housing 201 for access to the access port 232 of the vessel 226. In some embodiments or aspects, the door 248 may be normally closed. Figure 9 The direction of arrow A shown is slidably movable relative to the outer casing.

[0183] Continue to refer to Figure 8-9 The door 248 has an access hole 250, which is configured to align with the first opening 208 of the housing 201 when the door 248 is in the open position. In this way, the vessel access member can extend through the access hole 250 and the first opening 208 and into the access port 232 of the vessel 226.

[0184] Continue to refer to Figure 8-9 The cover 252 is attached to the housing 201 and configured to close the door 248 within the door cavity. The cover 252 is secured by, for example, one or more clips 216 (such as...). Figure 9 (As shown) It is non-removably attached to the body 204. In some embodiments or aspects, the cover 252 may be removably attached to the body 204 of the housing 201. In some embodiments or aspects, the cover 252 may be made of the same material as the body 204 and the cap 214 of the housing 201.

[0185] refer to Figure 9The door cover 252 has a door access opening 254 with a seal 256 and a utensil access opening 258 opposite to the first opening 208 of the housing 201 (e.g., Figure 8 (As shown). The vessel access opening 258 is configured to receive a spike or other vessel access member of the delivery system during administration of the therapeutic or diagnostic agent 228. When the door 248 is in the open position, the vessel access opening 258 is aligned with the access hole 250 on the door 248 to allow the spike or other vessel access member to extend through the first opening 208 on the housing 201 to access the access port 234.

[0186] refer to Figure 12 The seal 256 covers the door access opening 254 and can be pierced 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 sense the presence of the seal 256, for example by sensing 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 example because there is no resistance to movement through the door access opening 254, the controller 114 may be configured to prevent operation of the delivery system 100 because a used storage device 200 (i.e., a storage device with a pierced seal 256) or a tampered storage device 200 (i.e., a storage device with a removed seal 256) has been installed for use with the delivery system 100. In this way, the seal 256 acts as a security mechanism to ensure that only tamper-proof storage devices 200 can be used with the delivery system 100. In some embodiments or aspects, the seal 256 may also be provided on the vessel access opening 258. In some embodiments, the seal may be a component of the housing 201 that is broken or permanently deformed as evidence of use or tampering.

[0187] refer to Figure 13-14 A door lock 260 is shown according to some embodiments or aspects. The door lock 260 may be disposed on a door 248 for locking the door 248 in the open position after the door 248 has been moved from a closed position to an open position. In some embodiments or aspects, the door lock 260 includes at least one first hook 262 configured to engage with at least one second hook 264 on the housing 201 or the cover 252 (e.g., ...). Figure 8-9 (As shown). Each of at least one first hook 262 and at least one second hook 264 may have an angled contact surface 266 and a catch 268 configured to engage once the two contact surfaces 266 slide past each other. Figure 14It is shown that when the door 248 is in the open position, at least one first hook 262 and at least one second hook 264 are locked together. Due to this locking engagement, the door 248 cannot be moved back to the closed position.

[0188] In some embodiments or aspects, door 248 is movable between three different positions. In the initial position, door 248 can be closed. In the intermediate position, door 248 can be moved from the initial (closed) position to the open position to allow access to vessel 226. In the final position, door 248 can be moved to the closed position, in which door 248 engages with door lock 260 to prevent door 248 from being reopened and any remaining contents of vessel 226 from being accessed.

[0189] refer to Figure 15-19 This shows a storage device 200' according to another embodiment or aspect of this disclosure. Because... Figure 15-19 The structure of the storage device 200' shown is basically similar to that of the reference. Figure 7-14 The structure of the storage device 200 shown and described will be omitted, therefore detailed descriptions of the components of the storage device 200' will be omitted. Except in Figure 15-19 In addition to adding an apostrophe after each figure mark in the figure, Figure 15-19 Used with Figure 7-14 The same reference numerals used to describe components of storage device 200' are used to describe components of storage device 200'. The following detailed disclosure will focus only on the relative differences between the two storage devices.

[0190] In some embodiments or aspects, the storage device 200 may have at least one label, tag, or other marking 270 on the housing 201. While at least one label, tag, or other marking 270 is combined Figure 16 The embodiments of the storage devices shown herein are illustrated, but at least one label, tag, or other marking 270 may be applied to any storage device 200 described herein, such as those referred to herein. Figure 7-14The storage device 200 is described above. The at least one label, tag, or other mark 270 may contain machine-readable, authenticable data configured to be read by the delivery system 100 to authenticate the storage device 200 prior to use. In some embodiments or aspects, the machine-readable, authenticable data includes at least one of product information, manufacturing information, prescription information, and shipping condition information. The at least one label, tag, or other mark 270 may be a label (e.g., a barcode, QR code, or the like) and / or a mark (e.g., electronic, RFID, or the like) that includes at least one of product information, manufacturing information, prescription information, and shipping condition information related to a therapeutic or diagnostic agent. In some embodiments or aspects, the at least one label, tag, or other mark 270 may include a data logger configured to record, for example, temperature, shock, and / or pressure data. In some embodiments or aspects, the at least one label, tag, or other mark 270 may include a link to access information from a website or database.

[0191] In some embodiments or aspects, the storage device 200' may be configured such that it can be connected to the fluid cartridge only in a specific orientation. In this way, the access opening 254' on the door cover 252' of the storage device 200' can be properly aligned with the fluid cartridge for proper connection of the vessel access member to the access port 232' on the vessel 226'. (See also...) Figure 15-17B The housing 201' of the storage device 200' includes a guide mechanism 272 configured to position the storage device 200' relative to the fluid cartridge 300 in a desired orientation (e.g., see...). Figure 28 In some embodiments or aspects, the guide mechanism 272 includes one or more geometric features, such as grooves, chamfers, protrusions, holes, or tabs, which can be configured to mate with corresponding features of the fluid cartridge 300 to provide direct connection to the fluid cartridge 300 in a predetermined orientation.

[0192] refer to Figures 17A-17B The storage device 200' may have at least one identification feature 274 (such as... Figure 17BAs shown, it can be used to identify specific characteristics of storage device 200', such as the type of therapeutic or diagnostic agent in storage device 200'. At least one identification feature 274 can be one or more geometric features or physical markings, such as grooves, chamfers, protrusions, holes, or tabs. Such geometric features can be used to identify a specific storage device 200' and / or verify that storage device 200' is genuine. At least one identification feature 274 can have a corresponding identification feature on fluid cartridge 300. The same or different identification features 274 can be used in other aspects of the system, such as storage compartment 108 and used container compartment 112. This provides tangible feedback on the compatibility of the drug in storage container 200' with the shielding and temperature capabilities of the applicable storage compartment.

[0193] In some embodiments or aspects, at least a portion of the housing 201' of the storage device 200' may have a colored portion for identification purposes. For example, a specific color on at least a portion of the housing 201' of the storage device 200' may be used to identify the contents of the storage device 200', such as the type of therapeutic or diagnostic agent contained therein. In some embodiments or aspects, a specific color on at least a portion of the housing 201' of the storage device 200' may be used to identify the storage device 200' as a storage device 200' for training purposes only. Such a storage device 200' will not contain any therapeutic or diagnostic agents, but rather a safe, harmless liquid, optionally colored so that its behavior can be visualized.

[0194] refer to Figure 18-19 The storage device 200' includes a housing 201', within which a chamber 202' is defined (e.g., Figure 19 (As shown). The outer casing 201' has a body 204', which has a proximal end 206' with a first opening 208' and a closed distal end 210'. Figure 18-19 The storage device 200' shown has a proximal cap 276, which is configured to close the first opening 208' of the proximal end 206' of the housing 201', instead of having a cap 214 at the distal end 210, as shown. Figure 7-9 Like the storage device 200 shown.

[0195] Continue to refer to Figure 18-19The proximal cap 276 has a retainer 278, which has a base 280 connectable to at least one of the body 204' and the cover 252', and a retaining portion 282 projecting distally from the base 280. The retaining portion 282 has a generally cylindrical shape, with an inner surface 284 configured to engage the vessel 226' and an outer surface 286 having a threaded collar 288. The threaded collar 288 is configured to thread-engage with a cover 290 that encloses the vessel 226' within the chamber 202'. The cover 290 has threads 292 configured to thread-engage with the threaded collar 288 on the retaining portion 282. The distal end 294 of the cover 290 has an inner engagement surface 296 configured to contact the distal end 234' of the vessel 226'. A seal 298 may be provided at the interface between the retaining portion 282 and the cover 290.

[0196] refer to Figure 20 According to some embodiments or aspects of this disclosure, a component 150 having a storage device 200 and a fluid cartridge 300 is shown. As described herein, component 150 is configured to use an injector 170 (such as...). Figure 5 (As shown) Thermotherapy or diagnostic agents are delivered from storage device 200 via fluid cartridge 300. Fluid cartridge 300 is configured to be removably connected to injector 170 and can be connected to a saline source for saline flushing applications, perfusion, saline test injections, and saline infusions. Fluid cartridge 300 is also configured to be connected to vessel 226 of storage device 200 (e.g., Figure 8 (as shown), to deliver therapeutic or diagnostic agents 228 to the patient using injector 170.

[0197] In some embodiments or aspects, the storage device 200 and the fluid cartridge 300 may be configured to be removably interconnected. In other embodiments or aspects, the storage device 200 and the fluid cartridge 300 may be configured to be non-removably interconnected, such that when the storage device 200 is connected to the fluid cartridge 300, the storage device 200 cannot be removed from the fluid cartridge 300. This type of interlocking connection helps prevent any undesirable contact with therapeutic or diagnostic agents. Each fluid cartridge 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 cartridge 300 may be fluidly connected to the storage device 200 only, without any direct physical connection between their housings.

[0198] refer to Figure 21 The liquid box shown is 300 without... Figure 20The storage device is shown. The fluid cartridge 300 includes a housing 302 that encapsulates various components of the fluid cartridge 300. The housing 302 has a first portion 304 and a second portion 306. The first and second portions 304 and 306 may be removably or non-removably connected to each other. In some embodiments or aspects, the fluid cartridge 300 may have a substantially cuboid shape.

[0199] refer to Figure 22 The first and second portions 304, 306 of the housing 302 of the fluid cartridge 300 define an interior 308, which is configured to receive components of the fluid cartridge 300. In some embodiments or aspects, the fluid cartridge 300 may have a vessel access member, such as a spike 310, a metering device, such as a syringe 312, and a fluid path kit 314 received within the interior 308 of the housing 302. The fluid path kit 314 has tubing that fluidly connects the spike 310 to the syringe 312. In some embodiments or aspects, the fluid path kit 314 may have a particulate / air filter 317 (e.g., Figure 31 (As shown). In further embodiments or aspects, the fluid path kit 314 may have a valve block, as referenced herein. Figure 31 As described herein. In some embodiments, the valve block may have one or more valves to control fluid flow through the spike 310, syringe 312, and fluid path kit 314. The fluid path kit 314 is also configured for connection to an infusion kit, which will be referenced herein. Figure 31 Describe it.

[0200] Continue to refer to Figure 22 The spike 310 is configured to extend through the spike opening 315 in the housing 302 in the direction of arrow B between a retracted position and an extended position. In the retracted position, the spike 310 is contained 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, allowing the spike 310 to be inserted through the access port 232 of the vessel 226 (e.g., ...). Figure 8 (As shown). Alignment element 337 can be disposed on the spiked opening 315 of fluid cartridge 300 for aligning storage device 200 relative to fluid cartridge 300, such that when storage device 200 is connected to fluid cartridge 300, spike 310 is axially aligned to the access portion 232 of insertion container 226. A cap can be provided to close spiked opening 315 before use of fluid cartridge 300.

[0201] like Figure 23 As shown, the spike 310 has a body 320 with a proximal end 322, a distal end 324, and a hollow interior. The distal end 324 of the spike 310 has at least one puncture tip 326, which is configured to puncture the access port 232 of the vessel 226 (e.g., Figure 8(As shown). At least one puncture tip 326 may include two puncture tips 326, wherein the first of the two puncture tips 326 is configured to draw fluid from the vessel 226, and the second of the two puncture tips 326 is configured to deliver air into the vessel 226 while fluid is being drawn from the vessel 226. At least one puncture tip 326 is in fluid communication with the hollow interior of the body 320 of the spike 310 to deliver fluid from the access port 232 of the vessel 226 to a fluid path connector 328 adapted to connect to a fluid path kit 314. In this way, therapeutic or diagnostic agents from the vessel 226 can be delivered to the fluid path kit 314 through at least one puncture tip 326 and the fluid path connector 328 of the spike 310. In some embodiments or aspects, the spike may have a filter outlet 329 configured to allow air to enter the vessel 226 when fluid is drawn from the vessel 226. The spike 310 may have a collar 330 extending around the body 320. In some embodiments or aspects, an absorbent material 332 may be provided on the collar 330 for absorbing any droplets from the access port 232 when the spike 310 is inserted into or withdrawn from the access port 232. As described herein, the spike 310 also has a drive element 334 configured to engage with a spike driver of a delivery system. The drive element 334 may be an opening, slot, or other feature configured to engage with a spike driver of the delivery system for moving the spike 310 between a retracted position and an extended position. Figure 22 As shown, the spike drive groove 336 can be provided on the housing 302, so that the spike driver of the delivery system can extend into the interior 308 of the housing 302 to engage the spike 310.

[0202] refer to Figure 22 The syringe 312 has a barrel 338 with a proximal end 340 opposite to a distal end 342, defining an internal chamber 344 between them. The proximal end 340 is open and configured to receive a plunger 346. The distal end 342 has a port 350 in fluid communication with a fluid path assembly 314. As described herein, the plunger 346 is reciprocated within the barrel 338 of the syringe 312 by a syringe actuator of the delivery system. The plunger 346 is movable in the direction of arrow C, wherein proximal movement of the plunger 346 draws fluid into the internal chamber 344 via the port 350, and distal movement of the plunger 346 expels fluid from the internal chamber 344 via the port 350. Figure 21As shown, a portion of the plunger 346 protrudes from the housing 302 through the plunger opening 352. In some embodiments or aspects, the syringe driver of the delivery system may be configured to engage the proximal end of the plunger 346 protruding through the plunger opening 352. In other embodiments or aspects, the plunger 346 may be entirely contained within the housing 302 of the fluid cartridge 300.

[0203] refer to Figure 24 The syringe 312 has a barrel 338 at its distal end 342 with a flange 354 projecting radially outward from the barrel 338. The flange 354 is configured to be received in a flange groove 356 on the housing 302 to prevent movement of the barrel 338 relative to the housing 302 during the reciprocating motion of the plunger 346 within the barrel 338. The flange groove 356 may have a tapered geometry to ensure a tight fit with the flange 354.

[0204] refer to Figures 25A-25B The plunger 346 has a plunger cap 358 configured to lock the plunger 346 in a locked position and prevent its movement, thereby disabling the syringe 312 (as shown). Figure 22 The plunger cap 358 (shown) provides filling and dispensing functions. In some embodiments or aspects, the plunger cap 358 can be transported in a locked configuration, and the injector 170 can be configured to unlock 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 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 angled contact surfaces 366 and a latch 368 configured to engage once the two contact surfaces 366 slide past each other. Figure 25B It is shown that when the plunger cap 358 is pushed against the housing 302, at least one first hook 362 and at least one second hook 364 are locked into each other. Due to this locking engagement, the plunger 346 cannot move to fill or dispense fluid from the syringe 312. The plunger cap 358 is also configured to maintain the position of the syringe 312 in a set position such that the plunger 346 can be connected to the plunger drive mechanism during the installation of the fluid cartridge 300 into the delivery device 100.

[0205] refer to Figure 26 The fluid cartridge 300 has one or more alignment elements 370 for aligning the fluid cartridge 300 relative to the injector 170 of the delivery system 100 (e.g., ...). Figure 5 (As shown). In some embodiments or aspects, the housing 302 of the fluid cartridge 300 has a pair of alignment elements 370 configured as openings that are shaped to receive alignment pins 176 of the injector 170 (also shown). Figure 31(As shown in the diagram). Each pin 176 has a tapered surface configured to position the alignment element 370 on the fluid cartridge 370 as the alignment pin 176 moves toward the fluid cartridge 370. Once the alignment pin 176 is inserted into the alignment element 370, the fluid cartridge 300 is positioned in the desired location relative to the injector 170, allowing the spike 310 and plunger 346 to be operated. For example, the alignment of the alignment pin 176 with the alignment element 370 on the fluid cartridge 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 dispensing 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 also facilitates the alignment of valves and sensors of the delivery device 100 with corresponding positions on the fluid path assembly 314 in the fluid cartridge 300.

[0206] refer to Figure 27-30 This illustrates a fluid cartridge 300' according to another embodiment or aspect of this disclosure. Because... Figure 27-30 The structure of the fluid cell 300' shown is basically similar to that of the reference. Figure 20-26 The structure of the fluid cartridge 300 is shown and described, therefore detailed descriptions of the components of the fluid cartridge 300' will be omitted. Except in Figure 27-30 In addition to adding an apostrophe after each figure mark in the figure, Figure 27-30 Used in Figure 20-26 The same reference numerals used to describe the components of fluid cartridge 300' are used to describe the components of fluid cartridge 300'. The following detailed disclosure will focus only on the relative differences between the two storage devices.

[0207] refer to Figure 27 The liquid container 300' has a housing 302', the housing 302' having a recess 378, the shape of the recess 378 being receptive. Figure 15-19 The storage device 200' is shown. In some embodiments or aspects, the recess 378 is shaped such that the storage device 200' is connected to the fluid cartridge 300', and the resulting assembly 150 has a generally cuboid shape. (See reference herein) Figure 15-17B The storage device 200' discussed includes a housing 201' comprising a guide mechanism 272 configured to position the storage device 200' relative to the fluid cartridge 300' in a desired orientation. For example, see reference... Figure 28 The guide mechanism 272 includes one or more geometric features, such as grooves, chamfers, protrusions, holes, or tabs, which can be configured to mate with corresponding guide features 380 of the fluid cartridge 300' to provide a direct connection between the storage device 200' and the fluid cartridge 300' in a predetermined orientation. (See reference...) Figure 29The fluid cartridge 300' has one or more locking elements 382 for non-removably connecting the storage device 200' to the fluid cartridge 300'.

[0208] refer to Figure 31 An exemplary fluid diagram is shown, illustrating the fluid pathway between storage device 200 and fluid cartridge 300. (See example...) Figure 31 As shown, the vessel 226 of the storage device 200 is fluidly connected to the fluid path assembly 314 of the fluid cartridge 300 via a spike 310. The fluid path assembly 314 may have multiple valves to control the fluid flow from the vessel 226 to the infusion assembly 406. In some embodiments or aspects, a first valve 384 is located downstream of the spike 310 to regulate the fluid flowing from the spike 310 into the fluid path assembly 314. In some embodiments or aspects, the first valve 384 may be a pinch valve, a plug valve, or any other type of valve configured to selectively allow fluid to flow from the spike 310 into the fluid path assembly 314. In some embodiments or aspects, the first valve 384 may be operable between an open position and a closed position via an injector 170.

[0209] The flow path of the fluid path kit 314 can be configured to facilitate air removal during infusion and limit the formation of air bubbles within the material transferred from the container 226 of the storage device 200 to the syringe 312, for example, by limiting abrupt changes or transitions in the tubing diameter of the fluid path kit 314. The flow path of the fluid path kit 314 can be further configured to prevent any air bubbles from being transferred from the syringe 312, either by incorporating a tortuous fluid path to preferentially separate and transfer air bubbles, or by using a hydrophobic membrane. The flow path of the fluid path kit 314 can be designed to incorporate valves or other fluid control elements, such as passive valves, active valves, check valves, diverter valves, pinch valves, rotary valves, plug valves, or on / off valves.

[0210] Continue 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 within the fluid path assembly 314. In some embodiments or aspects, the air detector 180 is located on the injector 170 (see [link to original document]). Figure 5 and 32 The fluid cartridge 300 is positioned relative to the injector 170 such that the air detector 180 is configured to detect air in the fluid path assembly 314 at a location downstream of the first valve 384. In some embodiments or aspects, the output from the air detector 180 can be delivered to the system 100 ( Figure 5The controller 114 (shown) is used to allow or prevent the operation of the injector 170 based on the presence or absence of air in the fluid path kit 314. The air detector 180 can be configured to detect the presence of therapeutic or diagnostic agents in the tubing from the vessel 226 to aid in volumetric accuracy of dose delivery.

[0211] Continue to refer to Figure 31 An air / particulate filter 317 is disposed downstream of the air detector 180. In some embodiments or aspects, a valve block 316 is disposed downstream of the air detector 180. In some embodiments or aspects, the valve block 316 may be a manifold with multiple ports that can be selectively opened or closed to allow or restrict fluid flow through it. 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 such that only two of the three ports can be in fluid communication with each other. For example, if the valve block 316 is arranged such that the first and second ports 388, 390 are in fluid communication with each other and are fluidly isolated from the third port 392, the syringe 312 can be filled with a therapeutic or diagnostic agent from the vessel 226 via port 350. If valve block 316 is arranged such that the second and third ports 390, 392 are in fluid communication with each other and fluidly isolated from the first port 388, fluid from an auxiliary fluid source 394 (e.g., a saline source) can be delivered to port 350 of syringe 312 via auxiliary line 396. In this configuration, saline or other fluids can be delivered for patency checks, test infusions, or flushing procedures, as described herein. Auxiliary line 396 can be connected to an auxiliary branch 398 of fluid path kit 314. Auxiliary line 396 has a spike 395 for connection to auxiliary fluid source 394, a check valve 397, and a pair of connectors 399.

[0212] In some embodiments, a second valve 400 may be provided on the auxiliary branch pipe 398 for controlling the flow of fluid to the valve block 316. In some embodiments or aspects, the valve block 316 may be operated to selectively open or close the first, second, and third ports 388, 390, 392 via the injector 170. Similarly, the second valve 400 may be operated between open and closed positions via the injector 170.

[0213] Continue to refer to Figure 31 A third valve 402 is located downstream of port 350 of syringe 312. The third valve 402 can be operated between open and closed positions via injector 170. An air / particle filter 403 is located downstream of the third valve 402, prior to the fluid path assembly 314 terminating at end connector 404.

[0214] Continue to refer to Figure 31Infusion kit 406 is removably connected to fluid path kit 314 of fluid cartridge 300 via end connector 404. Infusion kit 406 has a proximal connector 408 configured for removable connection with end connector 404 of fluid path kit 314. In some embodiments or aspects, end connector 404 and proximal connector 408 may be Luer connectors. Infusion kit 406 also has a distal connector 410 configured for connection to conduit 412 or infusion cap 414. A pair of check valves 416 are disposed between the proximal and distal connectors 408, 410. In some embodiments or aspects, infusion kit 406 may be configured to connect to sensor device 416 having a blockage detection sensor 418 and an air detector 420. In some embodiments or aspects, blockage detection sensor 418 may be configured to pressure test the integrity of fluid path kit 314 prior to access to vessel 226.

[0215] refer to Figure 32 The image shows components of a fluid cartridge 300, a storage device 200, and an injector 170 configured to interact with the fluid cartridge 300 and the storage device 200. In some embodiments or aspects, the injector 170 includes an access mechanism 172 configured to access the door 248 of the storage device 200. Figure 8 (As shown) Moves from the closed position to the open position. The injector 170 also includes a delivery mechanism 174 configured to actuate the plunger 346 of the syringe 312 to fill the syringe 312 with a therapeutic or diagnostic agent from the storage device 200, or with an auxiliary fluid source 394 (such as...). Figure 31 The syringe 312 is filled with saline solution (as shown). The delivery mechanism 174 can also be configured to actuate the plunger 346 of the syringe 312 to deliver the contents of the syringe 312, such as a therapeutic agent, diagnostic agent, or saline solution, to the infusion kit 406 (as shown). Figure 31(As shown). While the fluid cartridge 300 and its fluid path elements have been shown as having a single syringe 312 and valves for fluid movement and control, pumps in addition to a single syringe 312 may also be used. In some embodiments or aspects, multiple pumps may be present, such as one syringe 312 for each of the medication and flushing fluids. 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 the medication and flushing fluid from the auxiliary fluid source 394 to provide the ability for dual flow, i.e., simultaneous delivery of both fluids, such that the total volumetric flow rate can be set independently of the medication delivery rate. One benefit of dilution introduction is the potential reduction in the chance of patient discomfort or reaction. A second objective is to reduce the time the TRT spends in the infusion vein before being introduced into the central circulation and diluted. See, for example, US2021 / 0187186 A1, which is incorporated herein by reference.

[0216] Continue 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 cartridge 300. Once the alignment pins 176 are inserted into the alignment elements 370, the fluid cartridge 300 is positioned in a desired location relative to the injector 170, allowing the spikes 310 and plungers 346 to be operated. The injector 170 also has an air detector 180 configured to detect air within the conduit of the fluid path kit 314. In some embodiments or aspects, the injector 170 may also have a fluid detector configured to detect the presence of fluid and / or other fluid-related properties. In some embodiments or aspects, the injector 170 also has a valve assembly 178 configured to selectively engage the conduit of the fluid path kit 314 to regulate fluid flow therethrough.

[0217] Once the storage device 200 is coupled to the fluid cartridge 300 and the assembly 150 is installed in the delivery system 100, the access mechanism 172 of the injector 100 is configured to move the door 248 from a closed position to an open position, allowing the spike 310 of the fluid cartridge 300 to extend to the access port 232 of the piercing vessel 226. (Reference) Figure 33 The access mechanism 172 of the injector 170 may have a probe 182, which is configured to pass through the access opening 254 in the cover 252 (e.g., Figure 9(As shown) extends in the direction toward door 248. In some embodiments or aspects, probe 182 may be configured to pierce seal 256 on access opening 254. Probe 182 may be configured to sense the presence of seal 256, for example by comparing the resistance to movement through door access opening 254 when seal 256 is present with the resistance to movement when seal 256 is absent. If probe 182 does not detect seal 256, for example because there is no resistance to movement through door access opening 254, then controller 114 ( Figure 5 The device shown can be configured to prevent the operation of the delivery system 100 because a used storage device 200 (i.e., a storage device with a punctured seal 256) or a tampered storage device 200 (i.e., a storage device with a removed seal 256) has been installed on the fluid. The operation of the probe 182 can be controlled by the controller 114.

[0218] Continue to refer to Figure 33 The fluid injector access mechanism 172 may also include a spike driver 184 configured to engage with the spike drive groove 336 of the spike 310 (e.g., Figure 23 (As shown) engagement. The spike driver 184 can move in a straight line from a first position and a second position, the first position corresponding to the retracted state of the spike 310 and the second position corresponding to the extended state of the spike 310, wherein the spike 310 pierces the access port 232 of the vessel 226. The operation of the spike driver 184 can be controlled by the controller 114.

[0219] Continue to refer to Figure 33 The delivery mechanism 174 includes a plunger driver 186 configured to actuate the plunger 346 of the syringe 312 to move the plunger 346 within the syringe barrel 312. The plunger driver 186 is shaped to be received in a plunger drive receiver 376 such that movement of the plunger driver 186 causes a corresponding movement of the plunger 346. The plunger driver 186 may have a motor for moving the plunger 346 in a linear direction. The plunger driver 186 can move linearly in a first direction and a second direction opposite to the first direction, in the first direction the syringe barrel 312 is configured to be filled with fluid, and in the second direction fluid from the syringe barrel 312 is configured to be delivered via port 350. Operation of the plunger driver 186 can be controlled by a controller 114. In some embodiments or aspects, the plunger driver 186 determines the flow rate of the fluid delivered to the patient.

[0220] Continue to refer to Figure 33Air detector 180 is configured to detect air within the piping of fluid path assembly 314. Air detector 180 may be an optical air detector, an acoustic air detector, an ultrasonic air detector, or any other air detector configured to detect the presence of air in the piping of fluid path assembly 314. Operation of air detector 180 may be controlled by controller 114.

[0221] Continue to refer to Figure 33 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 clamp the conduit of fluid path assembly 314. In some embodiments or aspects, valves 188 may be rotary stopcocks or other fluid flow shut-off mechanisms. Operation of valve assembly 178 may be controlled by controller 114.

[0222] refer to Figure 34 The sterilization mechanism 190 is configured to sterilize the access port 232 of the vessel 226. In some embodiments or aspects, the sterilization mechanism 190 includes a movable arm 192 and a sterilization source 194. The movable arm 192 is movable relative to the storage device 200, such that the sterilization source 194 can be located opposite the access port 232. The sterilization source 194 may include, for example, a laser or light emitter that can emit electromagnetic energy with wavelengths capable of inactivating organisms on the surface of the access port 232. Examples of such electromagnetic energy that can be emitted include ultraviolet (UV) light (light with wavelengths of 10-400 nanometers (nm), ultraviolet C (UV-C) light (light with wavelengths of 200-280 nm), white light, infrared (IR) light, lasers, etc. (e.g., the sterilization mechanism may include an ultraviolet light emitter, a UVC LED, an IR emitter, etc.). The emitted light can be continuously emitted onto the surface of the access port 232 during a pre-selected sterilization period to deliver a sufficient energy dose to inactivate organisms on the access port 232 before the spike 310 is inserted into the vessel 226 through the access port 232. In some embodiments or aspects, the sterilization source 194 can be configured to sterilize both the access port 232 and the spike 310 of the vessel 226. In this way, the access port 232 and the spike 310 are sterilized for aseptic connection between them. In a further embodiment or aspect, a second sterilization source 194 can be disposed on the movable arm 192 for sterilizing the spike 310 before it is inserted into the access port 232 of the vessel 226.

[0223] In some embodiments or aspects, disinfection source 194 may include a nozzle or sprayer that can spray antimicrobial material onto the access port, and / or an agitation mechanism that can wipe the antimicrobial agent onto the access port and continue disinfection for a preselected time. The selected disinfection time period may be based on the type of antimicrobial agent used and the time period required to eliminate a preselected group of organisms or reduce the number of these organisms to or below a preselected threshold level. In some embodiments or aspects, the antimicrobial material may be applied at the manufacturing site via an absorbent member containing the antimicrobial agent, similar to the absorbent member in SwabCap manufactured by ICU Medical Inc., San Clemente, California. Gate 248 may keep the absorbent member containing the antimicrobial agent in contact with the access port. The antimicrobial agent, such as 70% isopropanol, disinfects and then slowly evaporates. The continued presence of the absorbent member held by gate 248 maintains the sterility of the access port. The absorbent member moves with gate 248 to allow access to the access port.

[0224] refer to Figure 35 According to one embodiment or aspect, a storage container 450 for containing a plurality of storage devices 200 is shown. In some embodiments or aspects, the storage container 450 may be configured to contain the storage devices 200 during transport and storage prior to use. The storage container 450 has a housing 452 defining an interior 454 configured to receive the plurality of storage devices 200 therein. The housing 452 may have a receiving portion 456 and a lid portion 458 connected to the receiving portion 456 via a hinge 460. In some embodiments or aspects, the housing 454 of the storage container 450, such as at least one of the receiving portion 456 and the lid portion 458, may provide additional shielding properties to provide enhanced radiation shielding capabilities. In this way, radiation emitted by therapeutic or diagnostic agents contained within the storage devices 200 can be contained during transport and storage.

[0225] After dispensing a therapeutic or diagnostic agent from storage device 200 and injecting it into a patient, the materials used to inject the therapeutic or diagnostic agent into the patient are collected for storage and disposal. (Reference) Figure 36A disposal container 462 is provided for containing such material. In some embodiments or aspects, the disposal container 462 is configured to contain the storage container 200, fluid cartridge 300, and infusion line 406 used during the injection procedure. The disposal container 462 has a housing 464 defining an interior 466 configured to receive the used storage container 200, fluid cartridge 300, and infusion line 406. In some embodiments or aspects, the housing 466 of the disposal container 462 may provide shielding properties to provide radiation shielding capability. In this way, radiation emitted by the used storage container 200, fluid cartridge 300, and infusion line 406 can be contained for safe disposal. In some embodiments or aspects, the disposal container 462 may be configured to seal any remaining fluid in the used storage container 200, fluid cartridge 300, and infusion line 406.

[0226] Continue to refer to Figure 36 A label 474 (optionally printed by the delivery system 100) can be applied to the disposal container 462 to prevent it from being opened after used materials have been placed inside. The label 474 can also provide information about when the materials were used and when the disposal container 462 has been stored long enough for subsequent disposal. The label 474 may have a barcode or RFID tag, allowing disposal information to be provided to a computer in response to a barcode scanner or RFID reader reading the label 474.

[0227] Once used materials are placed in the labeled disposal container 462, the disposal container 462 can be temporarily stored in the trolley of the delivery system 100. In some embodiments or aspects, the labeled disposal container 462 may be stored in a disposal cabinet 476, such as... Figure 37 As shown. In some embodiments or aspects, the disposal cabinet 476 may have multiple drawers or shelves 478, each configured to hold multiple disposal containers 462. Labels 472 on the disposal containers 462 can be scanned by a user with a mobile barcode reader. If the read barcode indicates that the material inside the disposal container 462 has sufficiently decayed to be safely disposed of, an alarm such as a message, sound, and / or color can indicate that the scanned disposal container 462 can be removed from the disposal cabinet 476 and disposed of using an approved disposal method.

[0228] In some embodiments or aspects, the drawer or shelf 478 of the disposal cabinet 476 may have at least one indicator 480 (e.g., red and green LEDs) configured to indicate whether a particular disposal container 462 on the drawer or shelf 478 is safe to discard. For example, a user can scan the barcode of an individual disposal container 462 and provide additional input to the inventory management computer 482 to indicate that the individual disposal container 462 has been added to the drawer or shelf 478. The inventory management computer 482 can then determine, based on scan information associated with the used material (e.g., usage date, etc.), whether the material stored in each particular disposal container 462 has sufficiently decayed 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 device of at least one indicator 480 indicates that the material in the disposal container 462 is too radioactive to discard (e.g., by displaying red or other messages), or that the LED or other indicator device of at least one indicator 480 indicates that the material in the disposal container 462 is safe to discard (e.g., by displaying green or other messages). This labeling allows users to quickly determine whether the discard container 462 can be disposed of. This avoids the need for users to periodically scan the containers or check the usage date on the label 474 of each discard container 462 to determine its disposal status.

[0229] The disposal cabinet 476 may have a door 484 that closes its interior and a locking mechanism 486 for locking the door 484. In some embodiments or aspects, the locking mechanism 486 may be configured such that only a user with sufficient credentials can open the door 484 to enter the disposal cabinet 476. For example, the locking mechanism 486 may be such that the user must have a key to open the door 484, or must have a user badge or access permission associated with user login to provide input to the controller to unlock the door 484.

[0230] The systems and methods described herein provide the following capabilities and benefits: minimization of necessary connections, minimization of connections that must be separated or disconnected, and inclusion of every connection as much as possible. In some embodiments, methods, or systems, the only connection to be separated is the connection to the patient, and this is preferably done only after all medication has been delivered and the delivery connection has been flushed away. Therefore, the likelihood of any drips, spills, or leaks of liquid medication, aerosols, vapors, or gases being released is greatly reduced, which could pose a hazard to the operator or others nearby. Some radioactive offspring are gases. Chemotherapy aerosols can be harmful to those in the vicinity.

[0231] refer to Figure 38This illustrates an exemplary method of test infusion prior to the delivery of a therapeutic or diagnostic agent. At 500, patient P is connected to delivery system 100 via infusion kit 406, and patient P is administered a test infusion of saline or other fluid. For example, injector 170 can be operated to fill syringe 312 with saline or other fluid from auxiliary fluid source 394, and the test infusion of saline or other fluid can be delivered to the patient via infusion kit 406. The volume of saline or other fluid delivered to the patient is sufficient to confirm whether the saline or other fluid has been delivered to the patient's vascular system or whether there has been extravasation or leakage into the tissue. At 502, patient P and the authorized user AU administering treatment to patient P discuss the success of the saline or other fluid test infusion. For example, the authorized user AU may visually inspect the injection site for signs of extravasation and / or palpate the injection site. Patient P may report any discomfort associated with the saline or other fluid test infusion.

[0232] Continue to refer to Figure 38 At 504, a pre-infusion of saline or other fluid is administered to patient P. For example, injector 170 may be operable to fill syringe 312 with saline or other fluid from auxiliary fluid source 394 and deliver a test infusion of saline or other fluid to the patient via infusion kit 406 at a higher volume and for a longer duration than during the test infusion at 500. In some embodiments or aspects, the infusion volume, infusion duration, and / or infusion rate are selected to correspond to the infusion volume, infusion duration, and / or infusion rate used to deliver a therapeutic or diagnostic agent. Studies have shown that starting a saline infusion at the full infusion rate reduces the likelihood of extravasation and provides time for the perception of extravasation if it is to occur. At 506, an infusion of the therapeutic or diagnostic agent is administered to patient P using a predetermined infusion protocol. This process can be performed continuously with the pre-infusion of the previous process unless operator intervention is required.

[0233] refer to Figure 39 This illustrates an exemplary method of administering a therapeutic or diagnostic agent using a delivery system 100. At 510, the delivery system 100 is prepared for the administration procedure. For example, at 512, one or more storage devices 200 are loaded into one or more storage compartments 106 of a trolley 102. At 514, a fluid cartridge 300 is loaded into an injector 170. For example, the fluid cartridge 300 is located within a second drawer or shelf 110 of the trolley 102 such that the fluid cartridge 300 engages with the injector 170. In some embodiments or aspects, alignment elements 370 on the fluid cartridge 300 are configured to align with alignment pins 176 of the fluid injector (e.g., ...). Figure 26 (As shown) engagement, to position the fluid cartridge 300 relative to the injector 170, such that various components of the injector 170 can engage with corresponding components of the fluid cartridge 300.

[0234] Continue to refer to Figure 39 In section 516, an auxiliary fluid source 394 is connected to the fluid cartridge 300. For example, the auxiliary fluid source 394 can be connected via an auxiliary line 396 (such as...). Figure 31 (As shown) The fluid path kit 314 is punctured and fluidly connected to the fluid cartridge 300. At 518, the storage device 200 is connected to the fluid cartridge 300. In some embodiments or aspects, the storage device 200 may be scanned before or at the time of connection to the fluid cartridge 300. Figure 16 Labels, signs or other markings 270 on the storage device 200 are used to load information about the contents of the storage device 200 into the controller 114.

[0235] At 520, the infusion kit 406 is fluidly connected to the fluid path kit 314 of the fluid cartridge 300 (e.g., Figure 31 (as shown), and the fluid path kit 314 and infusion kit 406 have been filled. In some embodiments or aspects, the controller 114 of the delivery system 100 (as shown) Figure 5 (As shown) can be configured to initiate an infusion procedure in which syringe 312 is operated to draw fluid from auxiliary fluid source 394 into fluid path kit 314 and deliver fluid to infusion kit 406 to infuse fluid path kit 314 and infusion kit 406 with fluid.

[0236] Continue to refer to Figure 39 The test injection procedure is executed at 522. In some embodiments or aspects, the test injection procedure may include those described herein. Figure 38 The description is 500-504.

[0237] In 524, the delivery system 100 is configured to administer a therapeutic or diagnostic agent to a patient. For example, the syringe 312 may be operated to fill the vessel 226 of the storage device 200 with the therapeutic or diagnostic agent and deliver it to the patient P via the infusion kit 406 based on a predetermined administration protocol. In some embodiments or aspects, the delivery system 100 may be configured to administer a unit dose to the patient, wherein the unit dose requires the entire contents of the delivery vessel 226. In other embodiments or aspects, the delivery system 100 may be configured to administer a non-unit dose to the patient, wherein the non-unit dose requires a portion of the entire contents of the delivery vessel 226.

[0238] Continue to refer to Figure 39At 526, after the administration procedure is completed, the infusion kit 406 is disconnected from the patient P, and the components 150 of the storage device 200 and fluid cartridge 300 are removed from the injector 170. At 528, the used storage device 200, fluid cartridge 300, and infusion kit 406 are placed in the disposal container 462, and a label 474 is affixed to the disposal container 474 before it is placed in temporary storage on the cart 102. For example, the disposal container 462 may be loaded into the third drawer or shelf 112 of the cart 102.

[0239] At 530, in the clean treatment room, delivery system 100 is ready for another administration procedure. At 532, disposal container 462 is moved to disposal cabinet 476 for further in-situ decay of the radioactive material.

[0240] Using labels, tags, or other markings 270 on storage devices 200 to administer new doses and store used materials for disposal can also provide sufficient information to prompt for new dose ordering. For example, the inventory system may include a computer that receives information about the storage devices 200 that have been used, such as based on information contained in the labels, tags, or other markings 270 (e.g., ...). Figure 16 The inventory system (as shown) uses information to determine whether the quantity of available doses, based on the quantity of available storage devices 200, is below a pre-selected threshold used to trigger an order for additional doses. Optionally, the inventory system can compare the quantity of available doses with patient schedule loads. In some cases, the inventory system can relay this information to the allocation system to send automated messages to customers to help flag low inventory and prompt them to submit an order for new additional doses. The inventory system may include software configured to facilitate its use. For example, the software may be configured to facilitate inventory management and ordering, written instruction generation / acceptance, and compliance report generation. Furthermore, using labels, tags, or other markings 270 on storage devices 200 for the administration of new doses and for storing used materials for disposal can provide sufficient information to prompt accounting for the use of medications and systems, if this is a commercial arrangement.

[0241] Although embodiments or aspects have been described in detail for illustrative and descriptive purposes, it should be understood that such details are for illustrative and descriptive purposes only, and embodiments or aspects are not limited to the disclosed embodiments or aspects, but are instead intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that this disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. In fact, many of these features may be combined in ways not specifically stated in the claims and / or not disclosed in the specification. Although each dependent claim listed below may directly depend on only one claim, the disclosure of possible implementations includes combinations of each dependent claim with each other claim in the claim set.

Claims

1. A storage facility for managing the storage and disposal of used therapeutic or diagnostic agents, said storage facility comprising: A trolley having a storage compartment accessible through a lockable door, the storage compartment being configured to store one or more discard containers, each discard container comprising: Storage devices, including: A housing having a chamber defined therein; A vessel located within the cavity of the outer shell, the vessel being configured to store a radiopharmaceutical therein; and A door connected to the housing, the door being movable between an open position and a closed position, wherein, in the closed position, the door completely closes the cavity of the housing, wherein, in the closed position, the door covers an opening in the housing to close the cavity of the housing, and wherein, in the open position, the door exposes the opening in the housing for access to the inlet port of the vessel; and A fluid cartridge includes a vessel inlet component and a metering device. The storage device is attached to the fluid cartridge such that the vessel inlet component is inserted into the vessel to fluidly connect the metering device to the vessel. The metering device is connected to an infusion kit for injecting a predetermined dose of the radiopharmaceutical. The infusion kit, the storage device, and the fluid cartridge are held within the disposal container.

2. The inventory equipment according to claim 1, wherein, The trolley includes at least one indicator associated with the storage compartment to indicate whether any of the one or more disposal containers has been stored for a pre-selected storage period such that the radioactive components of the used therapeutic or diagnostic agent have decayed to a pre-selected safety threshold level.

3. The inventory equipment according to claim 1, wherein, The trolley includes wheels with wheel locks configured to prevent unauthorized movement of the trolley.

4. The inventory equipment according to claim 3, wherein, The wheel lock is an electronic lock that communicates with the controller.

5. The inventory equipment according to claim 3, wherein, The wheel lock is a mechanical lock with a key or other mechanical locking mechanism.

6. The inventory equipment according to claim 3, wherein, The wheel lock is operably connected to the lockable door such that the wheel is unlocked and can roll only after the lockable door is unlocked.

7. A method for manufacturing and dispensing a therapeutic or diagnostic agent, the method comprising: Fill the container with the therapeutic or diagnostic agent; Position the vessel within the cavity of a storage device with an outer shell; The storage device is closed so that the outer shell completely seals the vessel within the cavity; The storage device was transported to the management facility; The access mechanism of the delivery system opens the door of the storage device; The disinfection mechanism of the delivery system is used to disinfect the access port of the vessel; and The delivery system is used to access the therapeutic or diagnostic agent within the vessel via the access port.

8. The method according to claim 7, wherein, Accessing the therapeutic or diagnostic agent involves piercing the access port using a vessel access member connected to a box attached to the storage device.

9. The method of claim 7, further comprising reading a tag or label on the storage device to determine at least one of product information, production information, prescription information, and shipping condition information.

10. The method according to claim 7, wherein, Disinfecting the access port includes emitting ultraviolet light or outputting disinfectant materials.

11. A method for delivering a dose of a therapeutic or diagnostic agent, the method comprising: Insert the therapeutic or diagnostic agent into the container; Position the vessel within the cavity of a storage device with an outer shell; The door of the storage device is closed so that the outer casing completely seals the vessel inside the chamber to shield the radiation emitted by the radiopharmaceutical and prevent it from being emitted from the outer casing used to transport and store the radiopharmaceutical. The dosage of the radiopharmaceutical for the patient is determined based on the manufacturing information of the radiopharmaceutical included in the storage device. and Unlock the door of the storage device to open the outer casing, thereby accessing the radiopharmaceutical within the vessel and injecting the determined dose into the patient.

12. The method according to claim 11, wherein, Accessing the therapeutic or diagnostic agent involves piercing the access port using a vessel access member connected to a box attached to the storage device.

13. The method of claim 11, further comprising reading a tag or label on the storage device to determine at least one of product information, production information, prescription information, and shipping condition information.

14. The method according to claim 11 further includes disinfecting the access port of the vessel.

15. The method according to claim 14, wherein, Disinfecting the access port includes emitting ultraviolet light or outputting disinfectant materials.

16. A method for manufacturing and dispensing a radiopharmaceutical for targeted radionuclide therapy (TRT) or diagnostic imaging services, the method comprising: A radiopharmaceutical filling vessel is used for TRT or the diagnostic imaging service, wherein the radiopharmaceutical is a therapeutic or preventative effective amount of free metal cations of alkaline earth metal radium-223. Position the vessel within the cavity of a storage device with an outer shell; The storage device is closed so that the outer shell completely seals the vessel within the cavity; The storage device was transported to the management facility; The access mechanism of the delivery system opens the door of the storage device; The disinfection mechanism of the delivery system is used to disinfect the access port of the vessel; and The delivery system is used to access the radiopharmaceutical within the vessel via the access port.

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