Systems, methods and devices for the delivery of therapeutic or diagnostic agents - Patents.com

Abstract

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

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 312,145, filed February 21, 2022, and U.S. Provisional Application No. 63 / 312,148, filed February 21, 2022, the disclosures of which are incorporated by reference in their entireties herein.

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

[0003] Radiopharmaceuticals can be utilized for targeted radionuclide therapy (TRT) or diagnostic imaging. Radiopharmaceuticals generally include a radioisotope (e.g., Ac-255, Lu-177, etc.), a targeting moiety or biovector (e.g., antibody, peptide, antigen, small molecule, etc.), and a chelator (e.g., DOTA, NOTA, DTPA, etc.) optionally linked together into a single structure. In some cases, TRT can be just the radioisotope without a biovector or chelator, where the radioisotope is one that the human body naturally takes up into tissues or organs. The radiopharmaceutical is configured to interact with a target protein on a cell, such as a cancer cell. The radiopharmaceutical can be mixed in liquid or fluid form. In some examples or aspects, the radiopharmaceutical can be a solid particulate entrained in a fluid (e.g., a slurry suitable for injection into a patient). Administration is generally by intravenous administration into the systemic circulation.

[0004] Examples of TRT may include targeted alpha therapies (TAT) or targeted beta therapies (TBT). Such therapies may be administered as monotherapy or in combination, e.g., by simultaneous or sequential administration. Radioactive therapeutic agents for TAT emit primarily alpha radiation. The remainder of the radiation emitted from radioactive therapeutic agents for TAT may include gamma radiation and / or beta radiation. Radioactive therapeutic agents for TBT emit primarily beta radiation. The remainder of the radiation emitted for radioactive therapeutic agents for TBT may include gamma radiation and / or alpha radiation. Examples of targeted alpha therapies include, but are not limited to, thorium (Th-227), actinium (Ac-225), and lead (Pb-212) based therapies. Examples of targeted beta radiation therapy include lutetium (Lu-177), copper (Cu-67) or iodine (I-131) based therapies. Other examples of radioactive therapeutic agents can include alpha radiation therapy agents utilizing radium (Ra) (e.g., Ra-223 isotope such as XOFIGO® therapy offered by Bayer Health Care). Methods for the preparation, prepared solutions, and use of XOFIGO® are described in U.S. Patent No. 5,399,633, the disclosure of which is incorporated herein by reference in its entirety.

[0005] Radiopharmaceuticals used in TRT can pose significant challenges in manufacturing, storage, distribution, administration, handling, and disposal. Because the therapeutic agents are radioactive, they can cause radiation exposure to human health. Furthermore, given the decay properties of radiotherapeutic agents, the longer it takes to manufacture, process, and deliver the radiopharmaceutical to a patient, the less radioactivity will be present in the administered dose. There are substantial regulations that must be followed to keep radioactive materials safely stored and available, which can affect how therapeutic agents can be stored and transported, as well as who can use or administer the radiotherapeutic agents. For example, such regulations may require care providers to undergo hundreds of hours of training to be able to administer any TRT.

[0006] Figure 1 shows a conventional supply chain for TRT. Initially, radiopharmaceuticals are bulk manufactured at a manufacturing facility and loaded into bulk containers. Loads of such containers are delivered to a nuclear pharmacy where a nuclear pharmacist draws a dose, e.g., into a syringe, based on the prescription for a particular patient. The patient-ready dose is verified in a dose calibrator at the nuclear pharmacy to verify the prescribed dosing and assay. The dose is calibrated at the time of injection to ensure that the dose has the required activity at the time of injection. The verified dose is then transported to the treatment site where it is verified again in a dose calibrator. At the treatment site, the dose must typically be used within a certain time of dose draw before the half-life of the radioactive material makes the dose no longer suitable for patient use. After administration, the used syringe is verified again in a dose calibrator to verify that the correct prescribed dose was administered to the patient.

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

[0008] Conventional methods for dispensing and administering TRT and other therapeutic or diagnostic agents that require precise volumetric delivery from a controlled source significantly limit their application and use. After considering transportation, handling, and patient scheduling, the treatment site has only a limited amount of time to administer a dose to a particular patient. The challenges posed by variability in transportation, handling, and patient scheduling can affect the efficacy of TRT or other therapeutic or diagnostic agents, such as underdosing at the time of delivery of the medication to the patient. Due to these challenges associated with conventional systems and methods for dispensing and administering TRT and other therapeutic or diagnostic agents that require precise volumetric delivery from a controlled source, there is a need in the art for improved systems and methods for dispensing, handling, administering, and disposal of such therapies. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent No. 6,635,234 [Patent Document 2] US Patent Application Publication No. 2021 / 0187186 Summary of the Invention [Problem to be solved by the invention]

[0010] Given the problems with conventional systems and methods for dispensing, handling, administering, and disposing of TRT and other therapeutic or diagnostic agents, better supply chain methods are needed so that treatment locations can have TRT available and ready to use for longer periods of time. Additionally, improved systems and methods are needed to ensure that stored products are no longer patient specific. Instead, treatment locations can provide equipment to help administer treatment to any patient that may be at the location on any particular day, resulting in more flexibility in how products stored at the treatment location can be utilized so that effective amounts of radiopharmaceuticals can be delivered to the patient. Such patient specific dosing is accomplished without the need for dose calibrators at the treatment location, thereby reducing or eliminating the need for manual measurements and handling in designated hot labs. Doses, volumes, and concentrations can be accurately measured at the manufacturing or filling site where it is much more efficient to use dosing and filling equipment such as multiple dose calibrators with error detection and correction, automated processing of samples, automated recording of data, and accurate weighing or volume determination. More accurate equipment, and reduction or elimination of the possibility of human error, increases reliability throughout the supply chain. [Means for solving the problem]

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

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

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

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

[0015] In some embodiments or aspects of the present disclosure, an assembly is provided that is configured to connect to a delivery system for delivering a therapeutic or diagnostic agent. The assembly may include a storage device that contains the therapeutic or diagnostic agent, and a fluidic cassette that is fluidly connectable to the storage device to access the therapeutic or diagnostic agent. The storage device may include a housing having a chamber defined therein and a container disposed within the chamber. The container may have an interior configured to receive the therapeutic or diagnostic agent and an access port for accessing the interior. The storage device may further include a door associated with the housing, the door being movable 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 seal the chamber of the housing. In the open position, the door may expose an opening in the housing for accessing the access port of the container. The fluidic cassette may include a spike, a metering device, and a fluidic pathway set that fluidly connects the spike to the metering device. The fluidic cassette may further include a housing that encloses the spike, the metering device, and the fluidic pathway set. The storage device and fluid cassette may be configured to connect to a delivery system such that a door of the storage device is accessible by an access mechanism of the delivery system, and such that a spike and metering device of the fluid cassette is accessible by a delivery mechanism of the delivery system.

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

[0017] In some embodiments or aspects of the present disclosure, the storage device may include a guide mechanism configured to position the storage device in a desired orientation relative to the fluidic cassette. The guide 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 fluidic cassette. The one or more geometric features may prevent mating between incompatible system components.

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

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

[0020] In some embodiments or aspects of the disclosure, the delivery system further includes an injector controller configured to determine a dose of therapeutic or diagnostic agent to be drawn from the container into the metering device based on the machine-readable authentication data on the storage device. The injector controller may be further configured to determine a dose of therapeutic or diagnostic agent to be drawn from the container 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 various predefined therapeutic or diagnostic procedures.

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

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

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

[0024] In some embodiments or aspects of the disclosure, a method is provided for manufacturing and dispensing a therapeutic or diagnostic agent. The method may include filling a container with the therapeutic or diagnostic agent, placing the container in a chamber of a storage device having a housing, closing the storage device such that the housing completely encloses the container in the chamber, transporting the storage device to an administration facility, opening a door of the storage device using an access mechanism of a delivery system, sanitizing an access port of the container using a sanitization mechanism of the delivery system, and accessing the therapeutic or diagnostic agent in the container through the access port using the delivery system.

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

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

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

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

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

[0030] Clause 1: A storage device configured to connect to a delivery system for delivering a therapeutic or diagnostic agent, the storage device comprising: a housing having a chamber defined therein; a container disposed in the chamber, the container configured to receive a therapeutic or diagnostic agent, the container having a distal end opposite a proximal end, an interior defined therebetween, 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, the door covering an opening in the housing to seal the chamber of the housing, and in the open position exposing the opening in the housing for accessing the access port of the container; and a holder contacting the container within the chamber of the housing to secure the container relative to the housing such that the access port of the container is disposed in the opening of the housing, the door being movable between the closed position and the open position in response to actuation by an access mechanism of the delivery system.

[0031] Clause 2: A storage device as described in Clause 1, wherein the holder comprises a contact element for contacting the distal end of the container and a plurality of tabs connected to the contact element and configured to engage with an inner surface of the housing to secure the distal end of the container to the housing.

[0032] Clause 3: A storage device as described in clause 1 or 2, further comprising a plurality of ribs within the chamber of the housing and surrounding the opening, the plurality of ribs configured to secure the proximal end of the container to the housing.

[0033] Clause 4: A storage device as described in any one of clauses 1 to 3, further comprising a lock for securing the door in one of an open and closed position.

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

[0035] Clause 6: A storage device described in any one of clauses 1 to 5, wherein the door cover comprises a door access opening having a seal and a container access opening positioned opposite the housing opening.

[0036] Clause 7: A storage device as described in clause 6, wherein the seal is pierceable by an access mechanism of the delivery system.

[0037] Clause 8: A storage device described in any one of clauses 1 to 7, further comprising a label or tag on the housing containing machine-readable, verifiable data including at least one of product information, manufacturing information, prescription information, and shipping conditions information.

[0038] Clause 9: A storage device described in any one of clauses 1 to 8, wherein the opening in the housing is configured to receive a spike that extends into the access port to access the therapeutic or diagnostic agent when the door is in the open position.

[0039] Clause 10: A storage device described in any one of clauses 1 to 9, wherein the therapeutic or diagnostic agent is a radiopharmaceutical and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from emitting from the housing.

[0040] 11: An assembly configured to connect to a delivery system for delivering a therapeutic or diagnostic agent, the assembly comprising: a storage device containing the therapeutic or diagnostic agent; and a fluidic cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent, the storage device comprising: a housing having a chamber defined therein; a container disposed within the chamber, the container 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, the door covering an opening in the housing to seal the chamber of the housing and exposing the opening in the housing for accessing the access port of the container in the open position; the fluidic cassette comprising: a spike, a metering device, and a fluidic pathway set fluidly connecting the spike to the metering device; and a housing enclosing the spike, the metering device, and the fluidic pathway set, the storage device and the fluidic cassette being 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 the spike and the metering device of the fluidic cassette are accessible by a delivery mechanism of the delivery system.

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

[0042] Clause 13: An assembly described in clause 11 or 12, wherein the fluid path set comprises one or more valves operable by a delivery mechanism of the delivery system to regulate fluid flow through the fluid path elements.

[0043] Clause 14: An assembly described in any one of clauses 11 to 13, wherein the fluid cassette is connectable to a saline source.

[0044] Clause 15: An assembly described in any one of clauses 11 to 14, wherein the storage device comprises a guide mechanism configured to position the storage device in a desired orientation relative to the fluid cassette.

[0045] Clause 16: An assembly as described in clause 15, wherein the guide mechanism comprises one or more geometric features on the storage device, the one or more geometric features being configured to mate with corresponding one or more geometric features on the fluid cassette.

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

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

[0048] Clause 19: An assembly described in any one of clauses 11 to 18, wherein the therapeutic or diagnostic agent is a radiopharmaceutical and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from emitting from the housing.

[0049] Clause 20: A delivery system for delivering a therapeutic or diagnostic agent, the delivery system comprising: an injector having a delivery mechanism and an access mechanism; and a fluid delivery assembly removably connectable to the injector, the fluid delivery assembly comprising: a storage device containing the therapeutic or diagnostic agent; and a fluid cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent, the storage device comprising: a housing defining a chamber therein; a container disposed within the chamber, the container 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 adapted to open and close the injector. a door movable between a closed position and an open position relative to the housing via the access mechanism, which in the closed position covers an opening in the housing to seal a chamber of the housing and in the open position exposes the opening in the housing to access the access port of the container; the fluid cassette comprises a container access member, a metering device, and a fluid path set fluidly connecting the container access member to the metering device, and a housing enclosing the container access member, the metering device, and the fluid path set, and the container access member and the metering device of the fluid cassette are accessible by a delivery mechanism of the injector to fluidly connect the interior of the container with the metering device via the fluid path set.

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

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

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

[0053] Clause 24: A delivery system described in any one of clauses 21 to 23, wherein the injector controller is equipped with multiple dosing algorithms for various predefined therapeutic or diagnostic procedures.

[0054] Clause 25: A delivery system described in any one of clauses 20 to 24, wherein the fluid path set comprises one or more valves operable by a delivery mechanism of the delivery system to regulate fluid flow through the fluid path elements.

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

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

[0057] Clause 28: A delivery system according to any one of clauses 20 to 27, wherein the storage device is configured to be removably or non-removably connectable to the fluidic cassette.

[0058] Clause 29: A delivery system described in any one of clauses 20 to 28, further comprising a label or tag on the housing containing machine-readable, verifiable data including at least one of product information, manufacturing information, prescription information, and shipping conditions information.

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

[0060] Clause 31: An inventory device for managing the storage and disposal of used therapeutic or diagnostic agents, the inventory device comprising a cart having a storage compartment accessible via a lockable door and configured to store one or more waste containers, each of the waste containers comprising: a storage device comprising a housing having a chamber defined therein, a container disposed within the chamber of the housing, 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, where in the closed position the door completely encloses the chamber of the housing; and a fluid cassette comprising a container access member and a metering device, the storage device being secured to the fluid cassette such that the container access member is inserted into the container to fluidly connect the metering device to the container, the metering device being connected to an infusion set used to infuse a dose of the radiopharmaceutical, the infusion set, the storage device and the fluid cassette being held within the waste container.

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

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

[0063] Clause 34: The inventory device of clause 33, wherein the wheel lock is an electronic lock in communication with the controller.

[0064] Clause 35: An inventory device as described in clause 33 or 34, wherein the wheel lock is a mechanical lock having a key or other mechanical locking mechanism.

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

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

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

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

[0069] Clause 40: A method according to any one of clauses 37 to 39, wherein the step of disinfecting the access port comprises irradiating ultraviolet light or ejecting a disinfecting material.

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

[0071] Clause 42: The method of clause 41, further comprising reading a label, tag or other indicia to determine at least one of product information, manufacturing information, prescription information and shipping condition information.

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

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

[0074] Clause 45: The method of clause 43 or 44, further comprising the step of 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.

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

[0076] Clause 47: The method of clause 46, wherein the step of disinfecting the access port includes irradiating ultraviolet light or ejecting a disinfecting material.

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

[0078] Clause 49: An assembly configured for connection to a delivery system for delivering a radiopharmaceutical, the assembly comprising: a storage device containing a therapeutic or diagnostic agent; and a fluid cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent, the storage device comprising: a housing having a chamber defined therein; a container disposed within the chamber and containing a radiopharmaceutical therein, the radiopharmaceutical being a therapeutically or prophylactically effective amount of free metal cation of the alkaline earth metal radium-223; and a door associated with the housing, movable relative to the housing between a closed position and an open position, the door being configured to open and close the housing when in the closed ... and a door covering the opening of the housing to seal the chamber and exposing, in an open position, the opening of the housing for accessing the access port of the container; the fluid cassette comprising a container access member, a metering device, and a fluid path set fluidly connecting the container access member to the metering device; and a housing enclosing the container access member, the metering device and the fluid path set, wherein the storage device and the fluid cassette are configured to connect to a delivery system such that the door of the storage device is accessible by an access mechanism of the delivery system and the container access member and the metering device of the fluid cassette are accessible by a delivery mechanism of the delivery system.

[0079] Clause 50: A delivery system for delivering a therapeutic or diagnostic agent, the delivery system comprising: an injector having a delivery mechanism and an access mechanism; a fluid delivery assembly removably connectable to the injector, the fluid delivery assembly comprising: a storage device containing a therapeutic or diagnostic agent; and a fluid cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent, the storage device comprising: a housing having a chamber defined therein; a container disposed within the chamber of the housing and containing a radiopharmaceutical therein, the radiopharmaceutical being a therapeutically or prophylactically effective amount of a free metal cation of the alkaline earth metal radium-223; and a door associated with the housing, movable between a closed position and an open position relative to the housing via the access mechanism of the injector, the door covering an opening in the housing to seal the chamber of the housing and opening the access mechanism of the container to close the chamber of the housing. and a door exposing an opening in the housing for accessing the access port, wherein the fluid cassette comprises a container access member, a metering device, and a fluid path set fluidly connecting the container access member to the metering device, and a housing enclosing the container access member, the metering device, and the fluid path set, wherein the container access member and the metering device of the fluid cassette are accessible by a delivery mechanism of the injector to fluidly connect an interior of the container with the metering device via the fluid path set, and the injector comprises an injector controller configured to determine a dose of the radiopharmaceutical based on manufacturing data attached to the housing of the storage device, and the injector controller is communicatively connected to the injector to control the injector to inject the 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.

[0080] Clause 51: An inventory device for managing the storage and disposal of used radiopharmaceuticals, the inventory device comprising a cart having shelves accessible via a lockable door and configured to store waste containers, each of the waste containers comprising a storage device comprising a housing having a chamber defined therein, a container disposed within the chamber of the housing and 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, the door in the closed position completely enclosing the chamber of the housing; and a container access member. and a metering device, wherein the storage device is secured to the fluid cassette such that a container access member is inserted into the container to fluidly connect the metering device to the container, the metering device being connected to an infusion set used to infuse a dose of the radiopharmaceutical, wherein the infusion set, the storage device, and the fluid cassette are retained within a waste container, and the cart includes an indicator for the shelf to show which waste container has been stored for a preselected storage period such that the radiopharmaceutical has decayed such that the radioactivity of the material is below a preselected safety threshold level.

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

[0082] Clause 53: A method for storing and disposing of radiopharmaceuticals used in targeted isotope therapy or diagnostic imaging services, comprising the steps of: retrieving a storage device holding a container having a remaining portion of the radiopharmaceutical, a cassette to which the storage device is connected, and an infusion set for placement in a waste container; placing a label, tag or other indicia on the waste container to indicate the date of use; placing the waste container with the storage device, cassette and infusion set therein in a storage compartment; and indicating that the waste container is safe to discard after a preselected decay period has elapsed, wherein the radiopharmaceutical is a therapeutically or prophylactically effective amount of the free metal cation of the alkaline earth metal radium-223.

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

[0084] Clause 55: A radiopharmaceutical dosing injection system for a therapeutically or prophylactically effective amount of free metal cation of radium-223 according to any one of clauses 1 to 54.

[0085] Clause 56: An inventory device for the management, storage and disposal of a therapeutically or prophylactically effective amount of free metal cation of Radium-223 as defined in any one of clauses 1 to 55.

[0086] Clause 57: The method of any one of clauses 1 to 56, further comprising a therapeutically or prophylactically effective amount of free metal cation of radium-223. [Brief description of the drawings]

[0087] [Figure 1] FIG. 1 is a representative schematic diagram of a conventional supply chain for radiotherapeutic agents adapted for use with TRT according to the prior art. [Diagram 2] FIG. 1 is a representative schematic diagram of a conventional method for TRT administration according to the prior art. [Diagram 3] FIG. 1 is a representative schematic diagram of an improved supply chain for radiotherapeutic agents configured for use with TRT, according to some embodiments or aspects of the present disclosure. [Figure 4] FIG. 1 is a representative schematic diagram of an improved method for TRT administration according to some embodiments or aspects of the present disclosure. [Diagram 5] FIG. 1 is a perspective view of a system for dispensing, administering, and disposing of liquid products requiring precise volumetric delivery from a controlled source, according to some embodiments or aspects of the present disclosure. [Figure 6] FIG. 1 is a perspective view of a system for dispensing, administering, and disposing of liquid products requiring precise volumetric delivery from a controlled source, according to some embodiments or aspects of the present disclosure. [Figure 7] FIG. 1 is a perspective view of a storage device for storing a liquid product, such as a radioactive therapeutic agent, according to some embodiments or aspects of the present disclosure. [Figure 8] FIG. 8 is a cross-sectional perspective view of the storage device shown in FIG. [Figure 9] FIG. 8 is an exploded perspective view of the storage device shown in FIG. 7. [Figure 10] FIG. 2 is a cross-sectional perspective view of the storage device shown with a first container. [Figure 11] FIG. 13 is a cross-sectional perspective view of the storage device shown with a second container. [Figure 12]FIG. 13 is a detailed perspective view of a security cover on an access door of a storage device according to some embodiments or aspects of the present disclosure. [Figure 13] FIG. 13 is a detailed view of a locking mechanism for preventing reuse of a storage device, according to some embodiments or aspects of the present disclosure. [Figure 14] FIG. 13 is a detailed view of a locking mechanism for preventing reuse of a storage device, according to some embodiments or aspects of the present disclosure. [Figure 15] FIG. 1 is a perspective view of a storage device for storing a liquid product, such as a radioactive therapeutic agent, according to some embodiments or aspects of the present disclosure. [Figure 16] FIG. 16 is a side view of the storage device shown in FIG. [Figure 17A] 1 illustrates a bottom perspective view of a storage device according to some embodiments or aspects of the present disclosure. [Figure 17B] 1 illustrates a bottom perspective view of a storage device according to some embodiments or aspects of the present disclosure. [Figure 18] FIG. 16 is an exploded perspective view of the storage device shown in FIG. [Figure 19] FIG. 16 is a cross-sectional perspective view of the storage device shown in FIG. [Figure 20] FIG. 1 illustrates a perspective view of a storage device and a fluidic cassette for dispensing doses from the storage device, according to some embodiments or aspects of the present disclosure. [Figure 21] FIG. 21 is a perspective view of the fluidic cassette shown in FIG. 20. [Figure 22] FIG. 22 is an exploded perspective view of the fluidic cassette shown in FIG. 21. [Diagram 23] 1 is a perspective view of a container access member configured to pierce a container of a storage apparatus according to some embodiments or aspects of the present disclosure. [Figure 24] FIG. 13 is a detailed perspective view of a metering device connection interface of a fluidic cassette according to some embodiments or aspects of the present disclosure. [Figure 25A] FIG. 13 is a perspective view of the plunger cap in an unlocked position. [Figure 25B] FIG. 25B is a perspective view of the plunger cap of FIG. 25A in a locked position. [Figure 26] FIG. 1 is a perspective view of a fluidic cassette and components of a delivery system configured to interact with the fluidic cassette, according to some embodiments or aspects of the present disclosure. [Figure 27] FIG. 1 illustrates a perspective view of a storage device and a fluidic cassette for dispensing doses from the storage device, according to some embodiments or aspects of the present disclosure. [Figure 28] FIG. 28 is a detailed view of the connection between the storage device and the fluidic cassette shown in FIG. 27. [Figure 29] FIG. 29 is a perspective view of the fluidic cassette shown in FIG. 28. [Diagram 30] FIG. 30 is an exploded perspective view of the fluidic cassette shown in FIG. 29. [Diagram 31] 1 is a schematic diagram of fluid connections between a container of a storage device, a fluid cassette, and a patient delivery line, according to some embodiments or aspects of the present disclosure. [Diagram 32] 1 is a perspective view of a fluidic cassette and storage device, as well as components of an infusion system configured to interact with the fluidic cassette and storage device, according to some embodiments or aspects of the present disclosure. FIG. [Diagram 33] FIG. 33 is a perspective view of the components of the infusion system shown in FIG. [Diagram 34] FIG. 1 is a perspective view of a sterilization system for sterilizing a portion of a storage apparatus according to some embodiments or aspects of the present disclosure. [Diagram 35] FIG. 1 is a perspective view of a carrier tray for transporting multiple storage devices according to some embodiments or aspects of the present disclosure. [Diagram 36] FIG. 13 is a perspective view of a storage device and a disposal container for disposing of cassettes, according to some embodiments or aspects of the present disclosure. [Figure 37] 1 is a schematic diagram of a storage enclosure for storing multiple waste containers according to some embodiments or aspects of the present disclosure. FIG. [Figure 38] 1 is a flow diagram of a patency check procedure, according to some embodiments or aspects of the present disclosure. [Figure 39]1 is a flow diagram of an administration procedure using a system as described according to certain embodiments or aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] In Figures 1-39, like characters sometimes refer to the same components and elements unless otherwise stated.

[0089] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0090] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," and the like, relate to an embodiment or aspect as illustrated in the drawings and should not be considered limiting because the embodiment or aspect may assume various alternative orientations.

[0091] All numbers used in the specification and claims should be understood to be modified in all instances by the term "about". "About" means ±25% of the stated value, for example ±10% of the stated value. However, this should not be considered as limiting the analysis of values ​​under the doctrine of equivalents.

[0092] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to include the starting and ending values ​​and any and all subranges or subratios subsumed therein. For example, a range or ratio described as "1 to 10" should be considered to include any and all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10. That is, all subranges or subratios beginning with a minimum value of 1 or greater and ending with a maximum value of 10 or less. Ranges and / or ratios disclosed herein represent average values ​​across the specified ranges and / or ratios.

[0093] The terms "first," "second," and the like do not refer to a particular order or chronology, but rather to various conditions, characteristics, or elements.

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

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

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

[0097] Some non-limiting embodiments or aspects may be described herein in relation to a threshold value. As used herein, meeting a threshold may refer to a value greater than the threshold, more than the threshold, higher than the threshold, equal to or greater than the threshold, less than the threshold, less than the threshold, lower than the threshold, equal to or less than the threshold, etc.

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

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

[0100] When used with respect 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 with respect 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 with respect to a component of a fluid delivery system, such as a fluid reservoir, syringe, or fluid line, the term "upstream" refers to the direction away from the patient toward the injector relative to the normal flow of fluid in the injector system. When used with respect to a component of a fluid delivery system, such as a fluid reservoir, syringe, or fluid line, the term "downstream" refers to the direction away from the injector toward the patient relative to the normal flow of fluid in the fluid delivery system.

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

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

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

[0104] The term "therapeutic radiopharmaceuticals" as used herein includes beta therapy radiopharmaceuticals, alpha therapy radiopharmaceuticals, positron therapy radiopharmaceuticals, Auger therapy radiopharmaceuticals, gamma therapy radiopharmaceuticals, and / or combinations thereof.

[0105] As used herein, the term "therapeutic or diagnostic agent" refers to any diagnostic, imaging, radiotherapy or chemotherapy, therapeutic, or any other (reconstituted) liquid or powder used in a therapeutic or diagnostic capacity that requires precise dose delivery from a controlled source, where the dose is the amount of active ingredient. Dose delivery may be accomplished by precise volumetric delivery.

[0106] All radiation shields are piecemeal or partial. Adding a layer of half the thickness to a shield reduces the transmitted radiation by a factor of two. The effectiveness of a shield depends on the energy of the radiation being shielded. Thus, terms such as "block," "stop," or "prevent" radiation transmission or emission refer to the reduction of transmitted or emitted radiation to an acceptable level. This acceptable level may depend on local regulations, requirements, policies, or preferences. Many materials used in shields and associated guidelines are well known to those skilled in the art of insurance physics.

[0107] The present disclosure comprises, consists of, or consists essentially of the following examples of embodiments or aspects in any combination. Various examples of the present disclosure may be described separately. However, it should be understood that this is merely for ease of illustration and description. In implementing the present disclosure, one or more aspects of the present disclosure described in one example may be combined with one or more aspects of the present disclosure described in one or more of the other examples.

[0108] In various embodiments or aspects, the present disclosure relates to systems and methods for dispensing, storing, administering and disposing of radiopharmaceutical therapeutic agents. The present disclosure also relates to systems and methods for dispensing, storing, administering and disposing of other therapeutic or diagnostic agents that require precise volumetric delivery from a controlled source, such as chemotherapy drugs. As described herein, conventional methods for dispensing and administering therapeutic or diagnostic agents that require precise volumetric delivery from a controlled source significantly limit their applicability and use. After considering transportation, handling and patient scheduling, treatment sites have limited time to administer a dose to a particular patient. The systems and methods described herein provide improvements in dispensing, storing, administering and disposing of therapeutic or diagnostic agents to allow for longer time to administer a dose to a particular patient.

[0109] As described in various embodiments or aspects of the present disclosure, the storage device may be configured to store radioactive therapeutic agents from the point of manufacture for transport and storage at a treatment facility such that the radioactive therapeutic agents are fully sealed and stored until they are used. Each of the storage devices may be sized, shaped, and configured to provide appropriate radiation shielding for the radioisotope and dose being stored. The storage devices may be further packaged and surrounded by additional shielding. The housing of the storage device is configured to be opened and unsealed only at the treatment site utilizing a dedicated device, as described herein. In some embodiments or aspects, the storage device may be configured to store therapeutic or diagnostic agents other than radioactive therapeutic agents from the point of manufacture for transport and storage at a treatment facility such that the therapeutic or diagnostic agents are fully sealed and stored until they are used.

[0110] As described in various embodiments or aspects of the present disclosure, a system can be provided that includes a radiotherapeutic agent injection / infusion system that is specifically adapted to access a therapeutic or diagnostic agent stored in a storage device such that the material is only accessible for administration to a patient via the infusion / infusion system, and is otherwise prevented from being administered if the storage device is not recognized as an untampered storage device. The storage device can be configured such that only the injection / infusion system can open the storage device and access the therapeutic or diagnostic agent to inject the therapeutic or diagnostic agent into a patient. If the therapeutic or diagnostic agent is a radiopharmaceutical, the combination of the storage device and the injection / infusion system can help ensure that the radioactive material remains fully enclosed and contained from the time of manufacture until use. Furthermore, to facilitate safe containment and disposal of radioactive waste after use, the infusion / infusion system and the storage device once used can remain connected and non-openable.

[0111] As described in various embodiments or aspects of the present disclosure, systems and methods can be provided to calculate a dose for a particular patient based on patient parameters such as the therapeutic or diagnostic agent to be administered, the patient's weight, known manufacturing and / or calibration date, known radioactivity or other characteristics of the therapeutic or diagnostic agent at the time of manufacture, and known current date and time to determine an appropriate patient dose for injecting the patient with a volume of therapeutic or diagnostic agent corresponding to the calculated active dose of the therapeutic or diagnostic agent for treatment. If the therapeutic or diagnostic agent is a radiopharmaceutical, any unused portion of the radiopharmaceutical and other components that have come into contact with the radiopharmaceutical, which may be contaminated, may be stored in a waste container for storage until the radioactivity has degraded to an acceptable level (usually about 10 half-lives of the radioisotope) depending on the initial dose in the storage device. The systems and methods are configured such that dosing consistency can be ensured in that each patient receives the desired amount of therapeutic or diagnostic agent.

[0112] As described in various embodiments or aspects of the present disclosure, improved systems and methods are provided to ensure that stored products are no longer designed to be or need to be patient specific. Instead, the systems disclosed herein are configured to administer treatment to any patient that may be present at the site on any particular day, such that there is more flexibility in how stored products are utilized at the treatment site so that an effective dose of radiopharmaceutical can be delivered to the patient. Such patient-specific dosing is achieved without the need for a dose calibrator, thereby eliminating additional dose assays to prepare a dose for patient immediate use.

[0113] As described in various embodiments or aspects of the present disclosure, systems and methods may be provided to monitor therapeutic or diagnostic materials stored in a disposal container and indicate when the stored material has decayed sufficiently and is safe for disposal. Once that determination is made, instructions to the user (e.g., software prompts, or an LED light can be switched from red to green, or the red LED can be turned off and the green LED turned on, etc.) can be provided so that staff know that material is suitable for disposal, identify the material to be discarded, and dispose of the material appropriately.

[0114] As described in various embodiments or aspects of the present disclosure, the improved inventory management flexibility associated with the systems and methods described herein allows caregivers to more effectively manage inventory, which does not have to be managed using a simple first-in, first-out approach and / or an approach that requires each stored dose to be provided only to a single specific patient. Instead, inventory management and dose usage is managed to take into account various factors, including the patient's need to better manage the supply of available doses. For example, if a particular patient requires a large number of doses due to the patient's size (e.g., weight, height and weight, body composition, etc.), a newer, more radioactive vial of radioactive therapeutic agent can be selected to administer to the patient, such that only one vial (instead of multiple vials) is required to inject the dose into the patient. This allows for easier administration (e.g., only using one injection sequence) and provides more flexibility with regard to inventory management and administration, resulting in more efficient utilization of doses and less waste. In some situations, this type of flexibility can also help reduce exposure to clinicians during treatment administration and minimize subsequent cleanup methods after the patient has received their dose.

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

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

[0117] 5, a delivery system 100 for dispensing, administering, and disposing of therapeutic or diagnostic agents is shown, according to some embodiments or aspects of the present disclosure. As described herein, system 100 includes a number of components designed to work together to provide a safe, streamlined, and flexible dispensing of therapeutic or diagnostic agents. Delivery system 100 is further configured to help end users maintain and manage their inventory of therapeutic or diagnostic agents.

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

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

[0120] In some embodiments or aspects, the delivery system 100 may be configured to store, administer, and dispose of therapeutic or diagnostic agents that are radiopharmaceuticals, such as therapeutic radiopharmaceuticals. The therapeutic radiopharmaceuticals may be beta therapy radiopharmaceuticals in some embodiments or aspects. Beta therapy radiopharmaceuticals include, but are not limited to, lutetium-177, iodine-131, yttrium-90, copper-67, rhenium-188, and / or holmium-166. The therapeutic radiopharmaceuticals may be alpha therapy radiopharmaceuticals in some embodiments or aspects. Alpha therapy radiopharmaceuticals include, but are not limited to, radium-223, actinium-225, thorium-227, astatine-211, lead-212, and / or bismuth-213. The therapeutic radiopharmaceuticals may be Auger therapy radiopharmaceuticals in some embodiments or aspects. Auger therapy radiopharmaceuticals include, but are not limited to, terbium-161 and / or iodine-125. In some embodiments or aspects, the radiopharmaceutical is selected from the group consisting of 177Lu-oxodotreotide, 223Ra dichloride, 18F-flucyclobaine, 123I-isoflupane, 68Ga-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 radionuclide of the radiopharmaceutical configured for imaging or therapeutic use is conjugated to FAP (fibroblast activation protein), PSMA (prostate specific membrane antigen), DOTA (dodecanetetraacetic acid and its chelating derivatives), HER2 (human epidermal growth factor receptor 2), GPC-3 (glypican-3 protein), or other mechanism of action with the radiopharmaceutical.

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

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

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

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

[0125] With further reference to FIG. 5, the delivery system 100 further includes a controller 114 for controlling the delivery of doses of therapeutic or diagnostic agents. The controller 114 may be connected to one or more user displays 116 for displaying information regarding aspects of storage, administration, and / or disposal of the therapeutic or diagnostic agents. In some embodiments or aspects, the display 116 is a touch screen display that allows control via touch commands received from a user. The controller 114 may further be connected to an input device 118 for inputting data regarding 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, a keyboard, a mouse, a touch screen display, and / or any other input mechanism for inputting data and / or commands regarding the operation of the delivery system 100 to the controller 114. The input device 118 may include functionality for video conferencing. The controller 114 may further be connected to a camera 117. The camera may be used to provide input to the controller, such as reading machine-readable or human-readable labels or tags. The camera may be used to take, record, and / or communicate images of everything that is going on for use by on-site operators, off-site operators, or for training or archival purposes. In some embodiments or aspects, an output device 119, such as a printer, is provided. The printer 119 may be used to print labels for documents, labels for trash bins, travel cards for patients, reminders for patients, and / or guidelines for patients.

[0126] The 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 regarding one or more characteristics of the therapeutic or diagnostic agent. The at least one processor of the controller 114 may be further configured to operate various components of the delivery system 100 to achieve dose delivery to the patient according to a programmed protocol for the injection procedure. The controller 114 may include a computer readable medium, such as a memory, in which one or more injection protocols may be stored for execution by the at least one processor.

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

[0128] In some embodiments or aspects, the controller 118 can have different dosing algorithms for different predefined therapies and can utilize scanned bar codes, read RFID tags, and / or other inputs provided by a user to select the appropriate dosing algorithm to be executed to determine a dose for the patient.

[0129] 5, each of the storage compartments 106 is securable and configured to be accessed by an authorized user having an appropriate access protocol. For example, each of the storage compartments 106 may have a lock 120 operably connected to the controller 114. Operation of the lock 120 may require entry of a password or other authentication means, for example, using the display 116 or input device 118, to authenticate an authorized user of the delivery system 100.

[0130] Continuing to refer to FIG. 5 , one or more of the wheels 104 of the cart 102 may have a wheel lock 122 for selectively locking the wheels 104 to prevent movement of the cart 102. The wheel lock 122 may be configured to prevent unauthorized movement of the cart 102. For example, the wheel lock 122 may be operatively connected to the controller 114. Operation of the wheel lock 122 may require entry of a password or other authentication means, for example, using the display 116 or the input device 118, to authenticate an authorized user of the delivery system 100 and allow movement of the wheels 104. The wheel lock 122 may be a mechanical lock having a key or other mechanical locking mechanism. In some embodiments or aspects, the wheel lock 122 may be operatively connected to the lock 120 of the storage compartment 106 such that operation of one of the wheel lock 122 and the lock 120 also controls operation of the other of the wheel lock 122 and the lock 120. In some embodiments or aspects, an alarm system may be operatively connected to at least one of the lock 120 and the wheel lock 122 such that an alarm sounds or an alarm message is presented upon unauthorized use of the delivery system 100. In some embodiments or aspects, the alarm system may be configured to prevent operation of the delivery system 100 and / or movement of the cart 102, such as by securing the wheel lock 122. The cart 102 may also include a compartment 113 for storing auxiliary equipment that is not directly used in the infusion method but is necessary or useful throughout the procedure. For example, a survey meter or other radiation detector may be included to survey the outside of the packaging and / or storage container 200 upon checking into the cart. The survey meter may also be used to survey the outside of the assembly 150 after the injector to check for leaks. The survey meter may also be used to survey the patient, operator, and injection room for contamination, and the auxiliary equipment compartment 113 may also house a spill remediation kit for unusual cases where a spill occurs, such as if the IV exits the patient's arm during injection.The auxiliary equipment compartment may contain other items commonly found in a hot lab and required for this injection, as the advantage of this delivery system 100 is that it provides the capabilities and equipment necessary to safely deliver the drugs it is designed to deliver.

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

[0132] Instead of incorporating the injector 170 into the cart 102, the delivery system 100' shown in FIG. 6 has a separate injector 170' supported on a separate mobile base 124. The injector 170' is configured to receive an assembly 150 including a storage device 200 and a fluid cassette 300. The delivery system 100' further includes a controller 114' for controlling the delivery of doses of therapeutic or diagnostic agents. The controller 114' may be connected to one or more user displays 116' for displaying information regarding aspects of the storage, administration and / or disposal of the therapeutic or diagnostic agents. In some embodiments or aspects, the displays 116' are touch screen displays that allow control via touch commands received from a user. The user displays 116' may be configured to input data regarding the storage, administration and / or disposal of the therapeutic or diagnostic agents. In some aspects, some of the communications may be wireless such that continuous physical connections are not required between selected components. In some embodiments of the system 100, there may be one or more fixed carts 102' and one or more portable carts 102 in communication with each other to facilitate flexible or optimal storage and use of the associated materials. In busy sites, used assemblies 150 may be transferred from the mobile carts to the fixed carts, which may provide in-place secondary attenuation storage. This may 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 in-place secondary attenuation cabinets may be in different rooms or different facilities.

[0133] 7-9, a storage device 200 is shown according to one embodiment or aspect of the present disclosure. As described herein, the storage device 200 is configured to store a quantity of a therapeutic or diagnostic agent. In embodiments or aspects where the therapeutic or diagnostic agent is a radiopharmaceutical, the storage device 200 is configured to contain radiation emitted by a radioisotope of the radiopharmaceutical.

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

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

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

[0137] Alpha radiation is typically not difficult to block because alpha particles are large, have more limited penetrating power, and are generally administered in lower doses than beta radiation. The sidewalls of the housing 201 may be selected to be thick enough to shield alpha radiation. Because many of the isotopes that emit alpha and beta radiation or their daughter isotopes also emit gamma radiation, additional wall thickness or packing material may be provided within the cavity 224 to help secure the container 226 in the desired position and / or to provide additional shielding to prevent additional radiation exposure from the radiopharmaceuticals that are emitted outside the housing. The size of the housing 201 relative to the container 226 may be selected to set a minimum distance from the exterior of the housing 201 to the container 226 to reduce user exposure. However, in general, isotopes emit more than one type of radiation, or radiation at various energy levels with various penetrating powers. Additionally, all isotopes accumulate some daughter products during drug production and delivery. Thus, significant gamma radiation shielding may be necessary for what are nominally alpha or beta emitters. Materials used for shielding and associated guidelines are well known to those skilled in the art of health physics.

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

[0139] The container 226 has a proximal end 230 with an access port 232 and a closed distal end 234 defining an interior 236 therebetween. The access port 232 may be a pierceable septum configured to be pierced by a container access member or other access mechanism to access the therapeutic or diagnostic agent 228 within the interior 236 of the container 226, as described herein. During manufacture of the therapeutic or diagnostic agent 228, the container 226 may be filled with the therapeutic or diagnostic agent 228 and then sealed via the access port 232 to retain the therapeutic or diagnostic agent 228 therein. Filling of the container 226 may occur after the container 226 is connected or placed within the chamber 201 of the storage device 200 or prior to connecting or placing the container 226 within the chamber 201. In some embodiments or aspects, the access port 232 may be fully sterilized at the point of manufacture. The container 226 may also be a plastic vial, a flexible bladder, a collapsible bag, or a pre-filled syringe, preferably with a plunger but no handle to reduce the space required. The advantage of collapsible containers and pre-filled syringes is that air does not need to be pumped into the container when the fluid is removed because the container collapses or the plunger moves downward when the fluid is withdrawn.

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

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

[0142] 8 and 9, the storage device 200 has a holder 240 in the chamber 202 of the housing 201. The holder 240 may be configured to hold the distal end 234 of the container 226 relative to the housing 201. The holder 240 may contact the distal end 234 of the container 226 to fix the position of the container 226 relative to the housing 201. In some embodiments or aspects, the holder 240 includes a contact element 242 for contacting the distal end 234 of the container 226 and a plurality of tabs 244 connected to the contact element 242 and configured to engage the housing 201, such as an inner surface 246 of the inner portion 218 of the housing 201, to fix the position of the container 226 relative to the housing 201. As shown in FIGS. 9 and 10, the plurality of tabs 244 may 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 flex relative to the contact element 242 such that when the contact element 242 is pressed against the distal end 234 of the container 226, the plurality of tabs 244 provide a restoring force against movement of the holder 240 in a distal direction away from the distal end 234 of the container 226. In this manner, the holder 240 is configured to hold a plurality of different containers 226 regardless of their diameters and longitudinal lengths.

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

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

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

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

[0147] 12, the seal 256 covers the door access opening 254 and is pierceable by an access mechanism of the delivery system 100 as described herein. In some embodiments or aspects, the access mechanism of the delivery system 100 may be configured to detect the presence of the seal 256, such as by detecting resistance to movement through the door access opening 254 when the seal 256 is present. If the access mechanism of the delivery system 100 does not detect the seal 256, such as because there is no resistance to movement through the door access opening 254, the controller 114 may be configured to prevent the delivery system 100 from operating because a used storage device 200 (i.e., one with a pierced seal 256) or a tampered storage device 200 (i.e., one with the seal 256 removed) has been installed for use with the delivery system 100. In this aspect, the seal 256 serves as a security mechanism to ensure that only an unopened storage device 200 may be used with the delivery system 100. In some embodiments or aspects, a seal 256 may also be provided to cover the container access opening 258. In some embodiments, the seal may be a member of the housing 201 that is broken or permanently deformed as evidence of use or tampering.

[0148] 13-14, a door lock 260 according to some embodiments or aspects is shown. The door lock 260 may be provided on the door 248 to secure the door 248 in an open position after the door 248 moves 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 door cover 252 (as shown in FIGS. 8 and 9). Each of the at least one first hook 262 and the at least one second hook 264 may have an angled contact surface 266 and a catch 268 configured to engage after the two contact surfaces 266 slide against each other. FIG. 14 shows the at least one first hook 262 and the at least one second hook 264 in a fixed engagement with each other when the door 248 is in an open position. This fixed engagement prevents the door 248 from returning to the closed position.

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

[0150] 15-19, a storage device 200' according to another embodiment or aspect of the present disclosure is shown. The structure of the storage device 200' shown in FIGS. 15-19 is substantially similar to the structure of the storage device 200 shown and described with reference to FIGS. 7-14, so a detailed description of the components of the storage device 200' will be omitted. In FIGS. 15-19, the same reference numbers used to describe the components of the storage device 200' in FIGS. 7-14 are used to describe the components of the storage device 200, except that a "'" mark is added after each reference number in FIGS. 15-19. The following detailed disclosure will focus only on the relative differences between the two storage devices.

[0151] In some embodiments or aspects, the storage device 200 may have at least one label, tag, or other indicia 270 on the housing 201. Although the at least one label, tag, or other indicia 270 is illustrated with respect to the storage device embodiment shown in FIG. 16, the at least one label, tag, or other indicia 270 may be applied to any storage device 200 described herein, such as the storage device 200 described herein with reference to FIGS. 7-14. The at least one label, tag, or other indicia 270 may include 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 conditions information. At least one label, tag, or other indicia 270 may be a label (e.g., bar code, QR code, or the like) and / or tag (e.g., electronic, RFID, or the like) that includes at least one of product, manufacturing, prescription, and shipping conditions information regarding the therapeutic or diagnostic agent. In some embodiments or aspects, at least one label, tag, or other indicia 270 may include a data logger configured to record, for example, temperature, shock, and / or pressure data. In some embodiments or aspects, at least one label, tag, or other indicia 270 may include a link to access information from a website or database.

[0152] In some embodiments or aspects, the storage apparatus 200' may be configured such that the storage apparatus 200' can only be connected to a fluidic cassette in a particular orientation. In this aspect, the access opening 254' on the door cover 252' of the storage apparatus 200' may be properly aligned with the fluidic cassette for proper connection of the access port 232' on the container 226' with the container access member. With reference to FIGS. 15-17B, the housing 201' of the storage apparatus 200' includes a guide mechanism 272 configured to position the storage apparatus 200' in a desired orientation relative to the fluidic cassette 300 (see, e.g., FIG. 28). In some embodiments or aspects, the guide mechanism 272 includes one or more geometric features, such as grooves, chamfers, protrusions, holes, or tabs, that may be configured to mate with corresponding features of the fluidic cassette 300 to enable direct connection to the fluidic cassette 300 in a predetermined orientation.

[0153] 17A and 17B, the storage device 200' may have at least one identification feature 274 (shown in FIG. 17B) that can be used to identify a particular characteristic of the storage device 200', such as the type of therapeutic or diagnostic agent in the storage device 200'. The at least one identification feature 274 may be one or more geometric features or physical indicators, such as grooves, chamfers, protrusions, holes, or tabs. Such geometric features may be used to identify a particular storage device 200' and / or verify that the storage device 200' is an authentic storage device 200'. The at least one identification feature 274 may have an identification feature that corresponds to the fluid cassette 300. The same or different identification feature 274 may be used with respect to other aspects of the system, such as the storage compartment 108 and the used container compartment 112. This provides tangible feedback that the drug in the storage container 200' complies with the shielding and temperature capabilities of the applicable storage compartment.

[0154] In some embodiments or aspects, at least a portion of the housing 201' of the storage device 200' may have a colored portion that may be used for identification purposes. For example, a particular color of 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 in the storage device 200'. In some embodiments or aspects, a particular color of 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' does not contain any therapeutic or diagnostic agent other than a safe and harmless liquid that is optionally colored so that its behavior can be visualized.

[0155] 18 and 19, a storage device 200' includes a housing 201' having a chamber 202' (shown in FIG. 19) defined therein. The housing 201' includes a body 204' having a proximal end 206' with a first opening 208' and a closed distal end 210'. Instead of having a cap 214 at the distal end 210 as shown in the storage device 200 of FIGS. 7-9, the storage device 200' shown in FIGS. 18 and 19 includes a proximal cap 276 at the proximal end 206' of the housing 201' configured to seal the first opening 208'.

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

[0157] Referring to FIG. 20, an assembly 150 having a storage device 200 and a fluidic cassette 300 is shown according to some embodiments or aspects of the present disclosure. As described herein, the assembly 150 is configured to deliver a therapeutic or diagnostic agent from the storage device 200 via the fluidic cassette 300 using an injector 170 (shown in FIG. 5). The fluidic cassette 300 is configured for removably connection to the injector 170 and may be connected to a saline source for saline flush applications, priming, saline test injections and saline injections. The fluidic cassette 300 is further configured to connect to a reservoir 226 (shown in FIG. 8) of the storage device 200 for delivery of a therapeutic or diagnostic agent 228 to a patient using the injector 170.

[0158] In some embodiments or aspects, the storage device 200 and the fluidic cassette 300 may be configured to be removably connectable to one another. In other embodiments or aspects, the storage device 200 and the fluidic cassette 300 may be configured to be non-removably connectable to one another such that when the storage device 200 is connected to the fluidic cassette 300, the storage device 200 cannot be removed from the fluidic cassette 300. This type of interlocking connection helps prevent undesired contact with therapeutic or diagnostic agents. Each fluidic cassette 300 may be adapted to connect to one storage device 200 or a pair of storage devices 200. In further embodiments or aspects, the fluidic cassette 300 may only be fluidly connectable to the storage device 200 without a direct physical connection between their housings.

[0159] 21, the fluidic cassette 300 is shown without the storage device shown in FIG. The fluidic cassette 300 includes a housing 302 that encloses various components of the fluidic cassette 300. The housing 302 has a first portion 304 and a second portion 306. The first and second portions 304, 306 may be removably connectable or non-removably connectable to one another. In some embodiments or aspects, the fluidic cassette 300 may have a substantially rectangular parallelepiped shape.

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

[0161] 22, the spike 310 is configured to be extendable through a spike opening 315 in the housing 302 between a retracted position in the direction of arrow B 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 such that the spike 310 is insertable through an access port 232 (shown in FIG. 8) of the container 226. The spike opening 315 of the fluidic cassette 300 may be provided with an alignment element 337 for aligning the storage device 200 with respect to the fluidic cassette 300 such that the spike 310 is axially aligned for insertion into the access port 232 of the container 226 when the storage device 200 is connected to the fluidic cassette 300. A cap may be provided to seal the spike opening 315 prior to use of the fluidic cassette 300.

[0162] As shown in FIG. 23 , the spike 310 has a body 320 having a proximal end 322, a distal end 324, and a hollow interior. The distal end 324 of the spike 310 has at least one piercing tip 326 configured to pierce an access port 232 (shown in FIG. 8 ) of the container 226. The at least one piercing tip 326 may include two piercing tips 326, a first of the two piercing tips 326 configured to withdraw fluid from the container 226 and a second of the two piercing tips 326 configured to pump air into the container 226 as fluid is withdrawn from the container 226. The at least one piercing tip 326 is in fluid communication with the hollow interior of the body 320 of the spike 310 for delivering fluid from the access port 232 of the container 226 to a fluid pathway connector 328 adapted to connect to the fluid pathway set 314. In this aspect, a therapeutic or diagnostic agent from the container 226 may be delivered to the fluid pathway set 314 via at least one piercing tip 326 of the spike 310 and a fluid pathway connector 328. In some embodiments or aspects, the spike may have a filtered vent 329 configured to allow air to enter the container 226 as fluid is withdrawn from the container 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 to absorb dripping from the access port 232 as the spike 310 is inserted into or withdrawn from the access port 232. The spike 310 further has a drive element 334 configured to engage a spike drive of a delivery system, as described herein. The drive element 334 may be an opening, slot, or other feature configured to be engaged by a spike drive of a delivery system to move the spike 310 between the retracted and extended positions. As shown in FIG. 22 , a spike drive slot 336 may be provided in the housing 302 to allow the spike drive of the delivery system to extend into the interior 308 of the housing 302 to engage the spike 310.

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

[0164] 24, the barrel 338 of the syringe 312 has a flange 354 that projects radially outward from the barrel 338 at the distal end 342. The flange 354 is configured to be received in a flange slot 356 on the housing 302 to prevent movement of the barrel 338 relative to the housing 302 as the plunger 346 reciprocates within the barrel 338. The flange slot 356 may have a tapered shape to ensure a tight fit with the flange 354.

[0165] 25A and 25B, the plunger 346 has a plunger cap 358 configured to lock the plunger 346 in a fixed position and prevent it from moving such that the filling and dispensing functions of the syringe 312 (shown in FIG. 22) are disabled. In some embodiments or aspects, the plunger cap 358 may be shipped in a fixed configuration and the injector 170 may be configured to unlock the plunger cap 358 to allow movement of the plunger 346 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 an angled contact surface 366 and a catch 368 configured to engage after the two contact surfaces 366 slide past each other. 25B illustrates at least one first hook 362 and at least one second hook 364 that are fixedly engaged with one another when the plunger cap 358 is biased towards the housing 302. This fixed engagement prevents the plunger 346 from being moved to fill or dispense fluid from the syringe 312. The plunger cap 358 is further configured to maintain the position of the syringe 312 in a set position such that the plunger 346 can be connected to a plunger driver during installation of the fluid cassette 300 within the delivery device 100.

[0166] 26, the fluidic cassette 300 has one or more alignment elements 370 for aligning the fluidic cassette 300 relative to the injector 170 (shown in FIG. 5) of the delivery system 100. In some embodiments or aspects, the housing 302 of the fluidic cassette 300 has a pair of alignment elements 370 configured as openings shaped to receive alignment pins 176 of the injector 170 (also shown in FIG. 31). Each of the pins 176 has a tapered surface configured to position the alignment element 370 on the fluidic cassette 300 when the alignment pins 176 move in a direction toward the fluidic cassette 300. When the alignment pins 176 are inserted into the alignment elements 370, the fluidic cassette 300 is positioned in a desired position relative to the injector 170 such that the spike 310 and plunger 346 may be operated. For example, alignment of the alignment pins 176 with alignment elements 370 on the fluidic cassette 300 also aligns the delivery mechanism 174 with corresponding plunger driver receivers 376 on the plunger cap 358 to move the plunger 346 during fill and dispense operations. The plunger driver receivers 376 may have a tapered shape that corresponds to the tapered shape of the pins on the delivery mechanism 174. In some embodiments or aspects, the alignment elements 370 further facilitate alignment of the valves and sensors of the delivery device 100 with corresponding locations on the fluid pathway set 314 in the fluidic cassette 300.

[0167] 27-30, a fluid cassette 300' according to another embodiment or aspect of the present disclosure is shown. The structure of the fluid cassette 300' shown in FIGS. 27-30 is substantially similar to the structure of the fluid cassette 300 shown and described with reference to FIGS. 20-26, and therefore a detailed description of the components of the fluid cassette 300' will be omitted. In FIGS. 27-30, the same reference numbers are used to describe the components of the fluid cassette 300 in FIGS. 20-26, except that a "'" mark is added after each reference number in FIGS. 27-30. The following detailed disclosure will focus only on the relative differences between the two storage devices.

[0168] 27, the fluidic cassette 300' has a housing 302' with a recess 378 shaped to receive the storage device 200' shown in FIGS. 15-19. In some embodiments or aspects, the recess 378 is shaped such that when the storage device 200' is connected to the fluidic cassette 300', the resulting assembly 150 has a substantially rectangular parallelepiped shape. As described herein with reference to FIGS. 15-17B, the housing 201' of the storage device 200' includes a guide feature 272 configured to position the storage device 200' in a desired orientation relative to the fluidic cassette 300'. For example, with reference to FIG. 28, the guide feature 272 includes one or more geometric features, such as grooves, chamfers, protrusions, holes, or tabs, that may be configured to mate with a corresponding guide feature 380 of the fluidic cassette 300' for directly connecting the storage device 200' to the fluidic cassette 300' in a predetermined orientation. With reference to FIG. 29, the fluidic cassette 300' has one or more locking elements 382 for non-removably connecting the storage device 200' to the fluidic cassette 300'.

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

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

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

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

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

[0174] 31 , a third valve 402 is provided downstream of port 350 of syringe 312. Third valve 402 may be operable between open and closed positions via injector 170. An air / particle filter 403 is provided downstream of third valve 402 before fluid path set 314 terminates in end connector 404.

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

[0176] 32, the fluid cassette 300 and storage device 200 are shown along with components of an injector 170 configured to interact with the fluid cassette 300 and storage device 200. In some embodiments or aspects, the injector 170 includes an access mechanism 172 configured to move a door 248 (shown in FIG. 8) of the storage device 200 from a closed position to an open position. The injector 170 further includes a delivery mechanism 174 configured to actuate a plunger 346 of the syringe 312 to load the syringe 312 with a therapeutic or diagnostic agent from the storage device 200 or to load the syringe 312 with saline from an auxiliary fluid source 394 (shown in FIG. 31). The delivery mechanism 174 may be further configured to actuate the plunger 346 of the syringe 312 to deliver the contents of the syringe 312, such as a therapeutic or diagnostic agent or saline, to an infusion set 406 (shown in FIG. 31). Although the fluid cassette 300 and its fluid path elements are shown with a single syringe 312 and valves to move and control the fluids, pumps other than a single syringe 312 may be used. In some embodiments or aspects, there may be multiple pumps, e.g., one syringe 312 each for the drug and irrigation fluid. In some embodiments, one or more of the pumps may be a peristaltic pump, a diaphragm pump, or a piston pump. In some embodiments, the additional pumps may eliminate the need for some valves or may benefit from the use of additional valves. In some embodiments, it may be desirable to have separate pumps for the drug and irrigation fluid from the auxiliary fluid source 394 to provide the ability to have dual flows, i.e., to deliver two fluids simultaneously, so that the total volumetric flow rate can be set independently of the drug delivery rate. One advantage of a dilution introduction is to reduce the possibility of patient discomfort or reaction. A second is to reduce the time that the TRT is in the injecting vein before it is introduced into the central circulation where it is diluted. See, for example, U.S. Patent No. 5,399,323, which is incorporated herein by reference.

[0177] 32, the fluid injector includes one or more alignment pins 176 configured to engage one or more alignment elements 370 on the fluid cassette 300. When the alignment pins 176 are inserted into the alignment elements 370, the fluid cassette 300 is positioned at a desired position relative to the injector 170 such that the spike 310 and plunger 346 may be operated. The injector 170 further includes an air detector 180 configured to detect air in the tubes of the fluid path set 314. In some embodiments or aspects, the injector 170 may further include a fluid detector configured to detect the presence of fluid and / or other characteristics related to the fluid. In some embodiments or aspects, the injector 170 further includes a valve assembly 178 configured to selectively engage the tubes of the fluid path set 314 to regulate the flow of fluid therethrough.

[0178] When the storage device 200 is coupled to the fluid cassette 300 and the coupling assembly 150 is installed in the delivery system 100, the access mechanism 172 of the injector 170 is configured to move the door 248 from a closed position to an open position so that the spike 310 of the fluid cassette 300 can be extended to penetrate the access port 232 of the container 226. With reference to FIG. 33, the access mechanism 172 of the injector 170 can have a probe 182 configured to extend through the access opening 254 of the door cover 252 in a direction toward the door 248 (as shown in FIG. 9). In some embodiments or aspects, the probe 182 can be configured to penetrate a seal 256 on the access opening 254. The probe 182 can be configured to detect the presence of the seal 256, for example, by detecting resistance to movement through the door access opening 254 when the seal 256 is present compared to resistance to movement when the seal 256 is not present. If the probe 182 does not detect the seal 256, such as because there is no resistance to movement through the door access opening 254, the controller 114 (shown in FIG. 5 ) may be configured to prevent operation of the delivery system 100 because a used storage device 200 (i.e., one with a pierced seal 256) or an opened storage device 200 (i.e., one with the seal 256 removed) is placed in the fluid. Operation of the probe 182 may be controlled via the controller 114.

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

[0180] 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 barrel of the syringe 312. The plunger driver 186 is configured to be received in the plunger driver receiver 376 such that movement of the plunger driver 186 causes corresponding movement of the plunger 346. The plunger driver 186 may have a motor that moves the plunger 346 in a linear direction. The plunger driver 186 may be linearly movable in a first direction in which the barrel of the syringe 312 is configured to be filled with fluid, and in a second direction opposite the first direction in which fluid from the barrel of the syringe 312 is configured to be delivered through the port 350. The operation of the plunger driver 186 may be controlled via the controller 114. In some embodiments or aspects, the plunger driver 186 determines the flow rate of fluid delivered to the patient.

[0181] 33, air detector 180 is configured to detect air within the tubes of fluid path set 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 within the tubes of fluid path set 314. Operation of air detector 180 may be controlled via controller 114.

[0182] 33, the valve assembly 178 may include a number of valves 188. In some embodiments or aspects, the number of valves 188 may be pinch valves configured to pinch tubing of the fluid pathway set 314. In some embodiments or aspects, the valves 188 may be rotary stopcocks or other fluid flow shutoff mechanisms. Operation of the valve assembly 178 may be controlled via the controller 114.

[0183] 34, a sterilization mechanism 190 is provided for sterilizing the access port 232 of the container 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 apparatus 200 such that the sterilization source 194 can be positioned opposite the access port 232. The sterilization source 194 can include, for example, a laser or light emitter capable of emitting electromagnetic energy at a wavelength capable of inactivating bacteria on the surface of the access port 232. Such radiable electromagnetic energy can include, for example, ultraviolet (UV) light (10-400 nanometer (nm) wavelength light), deep ultraviolet (UV-C) light (light with a wavelength of 200-280 nm), white light, infrared (IR) light, laser, etc. (e.g., the sterilization mechanism can include a UV light emitter, a UVC LED, an IR emitter, etc.). The emitted light may be continuously irradiated onto the surface of the access port 232 for a preselected disinfection time to deliver a sufficient energy dose to inactivate bacteria on the access port 232 before the spike 310 is inserted through the access port 232 into the container 226. In some embodiments or aspects, the disinfectant source 194 may be configured to disinfect the access port 232 and spike 310 of the container 226. In this aspect, the access port 232 and spike 310 are disinfected for a sterile connection therebetween. In further embodiments or aspects, a second disinfectant source 194 may be provided on the movable arm 192 to disinfect the spike 310 before inserting the spike 310 into the access port 232 of the container 226.

[0184] In some embodiments or aspects, the sanitizing source 194 may include a nozzle or sprayer that can spray a sanitizing material onto the access port, and / or an agitation mechanism that can wipe the sanitizing agent onto the access port for a preselected sanitizing period. The sanitizing period selected may be based on the type of sanitizing agent utilized and the period of time required to eliminate a preselected set of bacteria with the sanitizing agent or reduce the amount of such bacteria below a preselected threshold level. In some embodiments or aspects, the sanitizing material may be applied at the manufacturing site via a sanitizing agent-containing absorbent member, similar to that of SwabCap manufactured by ICU Medical, Inc. of San Clemente, California. The door 248 may hold the sanitizing agent-containing absorbent member in contact with the access port. The sanitizing agent, for example 70% isopropyl alcohol, sanitizes and then slowly evaporates. The continued presence of the absorbent member held by the door 248 maintains the sterility of the access port. The absorbent member is moved with the door 248 to allow access to the access port.

[0185] 35, a storage container 450 for housing a plurality of storage devices 200 is shown according to one embodiment or aspect. In some embodiments or aspects, the storage container 450 may be configured to house the storage devices 200 during transportation and storage prior to use. The storage container 450 has a housing 452 defining an interior 454 configured to receive a plurality of storage devices 200 therein. The housing 452 may have a housing portion 456 and a lid portion 458 connected to the housing portion 456 by a hinge 460. In some embodiments or aspects, the housing 454 of the storage container 450, such as at least one of the housing portion 456 and the lid portion 458, may provide additional shielding properties to enhance radiation shielding capabilities. In this aspect, radiation emitted by therapeutic or diagnostic agents contained within the storage device 200 may be contained during transportation and storage.

[0186] After the therapeutic or diagnostic agent has been removed from the storage device 200 and injected into the patient, the materials used to inject the therapeutic or diagnostic agent into the patient are collected for storage and disposal. With reference to FIG. 36, a waste container 462 is provided for containing such materials. In some embodiments or aspects, the waste container 462 is configured to receive the storage container 200, the fluidic cassette 300, and the infusion tube 406 used during the injection procedure. The waste container 462 has a housing 464 defining an interior 466 configured to receive the used storage container 200, the fluidic cassette 300, and the infusion tube 406. In some embodiments or aspects, the housing 464 of the waste container 462 may be endowed with shielding properties to provide radiation shielding capabilities. In this aspect, radiation emitted by the used storage container 200, the fluidic cassette 300, and the infusion tube 406 may be contained for safe disposal. In some embodiments or aspects, the waste container 462 may be configured to seal off residual fluid within the used storage container 200 , the fluid cassette 300 , and the infusion tube 406 .

[0187] 36, a label 474, optionally printed by the delivery system 100, may be affixed onto the waste container 462 to prevent the waste container 462 from being opened after used material has been placed inside the waste container 462. The label 474 may also provide information regarding when the material has been used and whether the waste container 462 has been stored long enough for subsequent disposal. The label 474 may have a bar code or an RFID tag such that a bar code scanner or RFID reader can provide the disposal information to a computer in response to reading the label 474.

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

[0189] In some embodiments or aspects, a drawer or shelf 478 of a waste locker 476 can have at least one indicator 480 (e.g., red and green LEDs) configured to indicate whether a particular waste container 462 on the drawer or shelf 478 is safe for disposal. For example, a user can scan a barcode of an individual waste container 462 and provide other input to an inventory control computer 482 to indicate that the individual waste container 462 has been added to the drawer or shelf 478. The inventory control computer 482 can then determine whether the stored material in each particular waste container 462 has sufficiently decayed based on the scanned information associated with the used material (e.g., date of use, etc.) to control the state of the at least one indicator 480. For example, the inventory control computer 482 may control the state of at least one indicator 480 so that an LED or other indicator means of at least one indicator 480 indicates that the material in the waste container 462 is too radioactive to be disposed of (e.g., by displaying a red or other message) or that an LED or other indicator means of at least one indicator 480 indicates that the material in the waste container 462 can be disposed of (e.g., by displaying a green or other message). Such an indication may allow a user to quickly determine whether a waste container 462 can be disposed of. This may avoid the user having to periodically scan the containers or check the use date on the label 474 of each waste container 462 to determine the disposal status of the waste container 462.

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

[0191] Among the features, capabilities and advantages provided by the systems and methods described herein are the minimization of connections that must be made, the minimization of connections that must be disconnected or cut, and the storage of each connection as much as possible. In the use of some embodiments, methods or systems, the only connection that is disconnected is the connection to the patient, which is preferably done only after all drug has been delivered and the delivery connection has been flushed with drug. Thus, there is a very low chance of dripping, spilling or leaking of released liquid drug, aerosol, vapor or gas that could pose a danger to the operator or others nearby. Some radioactive daughter products are gases. Chemotherapy aerosols can be dangerous to nearby people.

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

[0193] 38, at 504, the patient P is administered a pre-infusion of saline or other fluid. For example, the syringe 312 may be filled with saline or other fluid from the auxiliary fluid source 394 and the injector 170 may be operated to deliver a test infusion of saline or other fluid to the patient via the infusion set 406 in a larger volume and for a longer period of time than during the test injection 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 for delivery of a therapeutic or diagnostic agent. Studies have demonstrated that starting the saline infusion at full infusion rate reduces the likelihood of spillage and allows time for spillage to be detected if it may occur. At 506, the patient P is administered an injection of the therapeutic or diagnostic agent using a predetermined injection protocol. This method may follow the pre-infusion of the previous method unless there is operator intervention.

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

[0195] 39, at 516, the auxiliary fluid supply 394 is connected to the fluidic cassette 300. For example, the auxiliary fluid supply 394 may be pierced and fluidly connected to the fluidic pathway set 314 of the fluidic cassette 300 via an auxiliary line 396 (shown in FIG. 31). At 518, the storage device 200 is connected to the fluidic cassette 300. In some embodiments or aspects, a label, tag, or other indicia 270 (shown in FIG. 16) on the storage device 200 may be scanned prior to or upon connection with the fluidic cassette 300 to load information regarding the contents of the storage device 200 into the controller 114.

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

[0197] 39, a test injection procedure is performed at 522. In some embodiments or aspects, the test injection procedure may include 500-504 described herein with reference to FIG.

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

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

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

[0201] The use of labels, tags, or other indicia 270 on the storage devices 200 for administration of new doses and storage of used material for disposal can also provide sufficient information to prompt ordering of new doses. For example, the inventory system can include a computer that receives information about the used storage devices 200, such as based on information contained in the labels, tags, or other indicia 270 (shown in FIG. 16 ), and determines whether the number of available doses is below a preselected threshold for issuing an order for additional doses, such as based on the number of available storage devices 200. Optionally, the inventory system may compare the number of available doses to the patient scheduling load. In some circumstances, the inventory system can communicate this condition to the distribution system, such that an automated message is sent to customers to flag low inventory and prompt submission of a new purchase order for additional doses. The inventory system can include software configured to facilitate use of the inventory system. For example, the software can be configured to facilitate inventory management and ordering, generation / acceptance of written instructions, and generation of compliance reports. Additionally, the use of labels, tags or other indicia 270 on the storage device 200 for administration of new doses and for storage of used material for disposal can also provide sufficient information to prompt billing regarding drug and system usage, if that is the business arrangement.

[0202] Although embodiments or aspects have been described in detail for purposes of illustration and description, it should be understood that such details are for that purpose only and that the embodiments or aspects are not limited to the disclosed embodiments or aspects, but on the contrary, are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect. Indeed, many of these features can be combined in ways not specifically recited in the claims and / or disclosed herein. Although each dependent claim listed below may depend directly on only one claim, the disclosure of possible implementations includes each dependent claim in combination with all other claims in the claim set. [Explanation of symbols]

[0203] 100 delivery system, delivery device, 100' delivery system, 102 portable cart, 102' stationary cart, 104 wheels, 106 storage compartment, 106' storage compartment, 108 first drawer or shelf, 110 second drawer or shelf, 112 third drawer or shelf, container compartment, 113 auxiliary equipment compartment, 114 controller, 114' controller, 116 user display, 116' user display, 117 camera, 118 input device, 119 output device, printer, 120 lock, 122 wheel lock, 124 mobile base, 150 coupling assembly, 170 injector, 170' injector, 172 access mechanism, 174 delivery mechanism, 176 alignment pin, 178 valve assembly, 180 air detector, 182 probe, 184 spike driver, 186 Plunger driver, 188 Valve, 190 Disinfection mechanism, 192 Movable arm, 194 Second disinfection source, 200 Storage device, storage container, 200' Storage device, storage container, 201 Housing, chamber, 201' Housing, 202 Chamber, 202' Chamber, 204 Body, 204' Body, 206 Proximal end, 206' Proximal end, 208 First opening, 208' First opening, 210 Distal end, 210' Distal end, 212 Second opening, 214 Cap, 216 Clip, 217 Gasket or seal, 218 Inner portion, 220 Outer portion, 222 Connector, 224 Cavity, 226 Receptacle, 226' Receptacle, 228 Therapeutic or diagnostic agent, 230 Proximal end, 232 Access port, 232' access port, 234 distal end, 234' distal end, 236 interior, 238 rib, 240 holder, 242 contact element, 244 tab, 246 interior surface, 248 door, 250 access opening, 252 door cover, 252' door cover, 254 door access opening, 254' access opening, 256 seal, 258 container access opening, 260 door lock, 262 first hook, 264 second hook, 266 contact surface, 268 catch, 270 label or tag, indicator, 272 guide mechanism, 274 identification feature, 276 proximal cap, 278 retainer, 280 base, 282 retention portion, 284 interior surface, 286 exterior surface, 288 threaded collar, 290cover, 292 threads, 294 distal end, 296 inner engagement surface, 298 seal, 300 fluid cassette, 300' fluid cassette, 302 housing, 302' housing, 304 first portion, 306 second portion, 308 interior, 310 spike, 312 syringe, 314 fluid path set, 315 spike opening, 316 valve block, 317 particle filter, air filter, 320 body, 322 proximal end, 324 distal end, 326 piercing tip, 328 fluid path connector, 329 filtered vent, 330 collar, 332 absorbent material, 334 drive element, 336 spike drive slot, 337 alignment element, 338 barrel, 340 proximal end, 342 distal end, 344 Internal chamber, 346 Plunger, 350 Port, 352 Plunger opening, 354 Flange, 356 Flange slot, 358 Plunger cap, 362 First hook, 364 Second hook, 366 Contact surface, 368 Catch, 370 Alignment element, 376 Plunger driver receiver, 378 Recess, 380 Guide mechanism, 382 Locking element, 384 First valve, 388 First port, 390 Second port, 392 Third port, 394 Auxiliary fluid supply, 395 Spike, 396 Auxiliary line, 397 Check valve, 398 Auxiliary branch, 399 Connector, 400 Second valve, 402 Third valve, 403 Air / particle filter, 404 End connector, 406 Infusion set, infusion tube, 408 Proximal connector, 410 Distal connector, 412, catheter, 414, priming cap, 416, check valve, sensor device, 418, occlusion detection sensor, 420, air detector, 450, storage container, 452, housing, 454, interior, housing, 456, receiving portion, 458, lid portion, 460, hinge, 462, labeled waste container, 464, housing, 466, interior, 474, label, 476, locker, 478, drawer or shelf, 480, indicator, 482, inventory control computer, 484, door, 486, locking mechanism

Claims

1. 1. A storage device configured for connection to a delivery system for delivering a therapeutic or diagnostic agent, said storage device comprising: a housing having a chamber defined therein; a container disposed within the chamber, the container configured to receive the therapeutic or diagnostic agent, the container having a distal end opposite a proximal end defining an interior therebetween, 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, the door covering an opening in the housing to seal the chamber of the housing in the closed position and exposing the opening in the housing to access the access port of the container in the open position; a holder that contacts the container within the chamber of the housing to secure the container relative to the housing such that the access port of the container is positioned in the opening of the housing; Equipped with the door is movable between the closed position and the open position in response to actuation by an access mechanism of the delivery system. Storage device.

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

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

4. The storage device of claim 1 , further comprising a lock for securing the door in one of the open and closed positions.

5. The storage device of claim 1 , further comprising a door cover connected to the housing, the door cover enclosing the door within a door chamber.

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

7. The storage device of claim 6 , wherein the seal is pierceable by the access mechanism of the delivery system.

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

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

10. 10. The storage device of claim 1, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and the housing comprises shielding configured to prevent radiation from the radiopharmaceutical from emitting from the housing.

11. 1. An assembly configured to connect to a delivery system for delivering a therapeutic or diagnostic agent, said assembly comprising: a storage device for containing the therapeutic or diagnostic agent; a fluidic cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent; Equipped with The storage device is a housing having a chamber defined therein; a container disposed within the chamber, the container having an interior configured to receive the therapeutic or diagnostic agent and an access port for accessing the interior; a door associated with the housing, the door being movable relative to the housing between a closed position and an open position, the door covering an opening in the housing to seal the chamber of the housing in the closed position and exposing the opening in the housing to access the access port of the container in the open position; Equipped with The fluid cassette comprises: a container access member, a metering device, and a fluid pathway set fluidly connecting the container access member to the metering device; a housing enclosing the container access member, the metering device, and the fluid path set; Equipped with the storage device and the fluid cassette 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 the container access member and the metering device of the fluid cassette are accessible by a delivery mechanism of the delivery system. assembly.

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

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

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

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

16. 16. The assembly of claim 15, wherein the guide mechanism comprises one or more geometric features on the storage device, the one or more geometric features configured to mate with one or more corresponding geometric features on the fluidic cassette.

17. 12. The assembly of claim 11, wherein the outlet of the metering device of the fluidic cassette is configured to connect to an infusion set for delivering a dose of the therapeutic or diagnostic agent from the container to the infusion set.

18. 12. The assembly of claim 11, further comprising a label or tag on the housing containing machine-readable, verifiable data including at least one of product information, manufacturing information, prescription information, and shipping terms information.

19. 12. The assembly of claim 11, wherein the therapeutic or diagnostic agent is a radiopharmaceutical, and the housing comprises shielding configured to prevent radiation from the radiopharmaceutical from emitting from the housing.

20. 1. A delivery system for delivering a therapeutic or diagnostic agent, said delivery system comprising: an injector having a delivery mechanism and an access mechanism; a fluid delivery assembly removably connectable to the injector, a storage device for containing the therapeutic or diagnostic agent; a fluidic cassette fluidly connectable to the storage device for accessing the therapeutic or diagnostic agent; a fluid delivery assembly comprising: Equipped with The storage device is a housing having a chamber defined therein; a container disposed within the chamber, the container having an interior configured to receive the therapeutic or diagnostic agent and an access port for accessing the interior; a door associated with the housing, the door being movable relative to the housing between a closed position and an open position via the access mechanism of the injector, the door covering an opening in the housing in the closed position to seal the chamber of the housing, and exposing the opening in the housing in the open position to access the access port of the container; Equipped with The fluid cassette comprises: a container access member, a metering device, and a fluid pathway set fluidly connecting the container access member to the metering device; a housing enclosing the container access member, the metering device, and the fluid path set; Equipped with the vessel access member and the metering device of the fluid cassette are accessible by the delivery mechanism of the injector to fluidly connect the interior of the vessel with the metering device via the fluid path set. Delivery system.

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

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

23. 23. The delivery system of claim 22, wherein the injector controller is configured to connect to a hospital network system.

24. 23. The delivery system of claim 22, wherein the injector controller comprises multiple dosing algorithms for various predetermined therapeutic or diagnostic procedures.

25. 21. The delivery system of claim 20, wherein the fluid path set comprises one or more valves operable by the delivery mechanism of the delivery system to regulate fluid flow through the fluid path set.

26. 21. The delivery system of claim 20, wherein the fluid cassette is connectable to a saline source.

27. 21. The delivery system of claim 20, wherein the outlet of the metering device of the fluidic cassette is configured to connect to an infusion set to deliver a dose of the therapeutic or diagnostic agent from the container to the infusion set.

28. 21. The delivery system of claim 20, wherein the storage device is configured to be removably or non-removably connectable to the fluidic cassette.

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

30. 21. The delivery system of claim 20, wherein the therapeutic or diagnostic agent is a radiopharmaceutical and the housing includes shielding configured to prevent radiation from the radiopharmaceutical from emitting from the housing.

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