JP-7856779-B2 - Systems, methods, and apparatus for the delivery of therapeutic or diagnostic agents.

JP7856779B2JP 7856779 B2JP7856779 B2JP 7856779B2JP-7856779-B2

Inventors

ジョン・ヴォルカー
ジョー・ティング
ブライアン・ユー
ライアン・ベイン
ジョアナ・オリヴェイラ・レゴ・ブリランテ
アン・ベリット・エイド
エリア・フー
ハムシニ・スンダララマン
アシュリー・コッカーハム
ウィンストン・ジー
アンドリュー・ジョーンズ
リッチ・ミラー

Assignees

バイエル・ヘルスケア・エルエルシー

Dates

Publication Date: 20260511
Application Date: 20230220
Priority Date: 20220221

Claims (20)

A storage device configured to be connected to a delivery system for delivering therapeutic or diagnostic drugs, wherein the storage device is A housing with a defined chamber inside, A container placed within the chamber, configured to receive the therapeutic or diagnostic agent, having a distal end opposite a proximal end, with an interior defined between them , and the proximal end having an access port for accessing the interior; A door associated with the housing, which is movable relative to the housing between a closed position and an open position, and in the closed position covers the opening of the housing to seal the chamber of the housing, and in the open position exposes the opening of the housing to access the access port of the container, A holder that contacts the container within the chamber of the housing to secure the container to the housing, such that the access port of the container is positioned at the opening of the housing, Equipped with, The door is movable between the closed position and the open position in response to operation by the access mechanism of the delivery system. Storage device.
The storage device according to claim 1, wherein the holder comprises a contact element for contacting the distal end of the container, and a plurality of tabs connected to the contact element and configured to engage with the inner surface of the housing to secure the distal end of the container to the housing.
The storage device according to claim 1, further comprising a plurality of ribs within the chamber of the housing, the plurality of ribs surrounding the opening, and the plurality of ribs configured to fix the proximal end of the container to the housing.
The storage device according to claim 1, further comprising a lock for fixing the door in either the open or closed position.
The storage device according to claim 1, further comprising a door cover connected to the housing, wherein the door cover surrounds the door within the door chamber.
The storage device according to claim 5 , wherein the door cover comprises a door access opening having a seal and a container access opening positioned opposite the opening of the housing.
The storage apparatus according to claim 6, wherein the seal can be perforated by the access mechanism of the delivery system.
The storage device according to claim 1, further comprising on the housing a label or tag containing machine-readable verifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.
The storage device according to claim 1, wherein the opening of the housing is configured to receive a container access member extending into the access port to access the therapeutic or diagnostic agent contained in the container when the door is in the open position.
The storage device according to claim 1, wherein the therapeutic agent or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.
An assembly configured to connect to a delivery system for delivering therapeutic or diagnostic agents, wherein the assembly is A storage device for containing the aforementioned therapeutic or diagnostic agent, A fluid cassette that can be fluidly connected to the storage device to access the aforementioned therapeutic or diagnostic agent, Equipped with, The aforementioned storage device is A housing with a defined chamber inside, A container placed within the chamber, having an interior configured to receive the therapeutic or diagnostic agent, and an access port for accessing the interior, A door associated with the housing, which is movable relative to the housing between a closed position and an open position, and in the closed position covers the opening of the housing to seal the chamber of the housing, and in the open position exposes the opening of the housing to access the access port of the container, Equipped with, The aforementioned fluid cassette is A container access member, a measuring device, and a fluid path set for fluidly connecting the container access member to the measuring device, The container access member, the measuring device, and the housing surrounding the fluid path set, Equipped with, The storage device and the fluid cassette are configured to be connected to the delivery system such that the door of the storage device is accessible by the access mechanism of the delivery system, and the container access member and the metering device of the fluid cassette are accessible by the delivery mechanism of the delivery system. assembly.
The assembly according to claim 11, wherein the container access member of the fluid cassette is insertable into the access port of the container when the door is moved to the open position in order to fluidly connect the metering device to the container via the fluid path set.
The assembly according to claim 11, wherein the fluid path set comprises one or more valves that can be operated by the delivery mechanism of the delivery system to regulate the flow of fluid through the fluid path set .
The assembly according to claim 11, wherein the fluid cassette is connectable to a saline solution supply source.
The assembly according to claim 11, wherein the storage device comprises a guide mechanism configured to position the storage device in a desired orientation relative to the fluid cassette.
The assembly according to claim 15, wherein the guide mechanism comprises one or more geometric feature portions on the storage device, and the one or more geometric feature portions are configured to be coupled with one or more corresponding geometric feature portions on the fluid cassette.
The assembly according to claim 11, wherein the outlet of the metering device of the fluid cassette is configured to connect to the infusion set in order to deliver the dose of the therapeutic or diagnostic agent from the container to the infusion set.
The assembly according to claim 11, further comprising on the housing a label or tag containing machine-readable verifiable data including at least one of product information, manufacturing information, prescription information, and transport conditions information.
The assembly according to claim 11, wherein the therapeutic agent or diagnostic agent is a radiopharmaceutical, and the housing comprises a shield configured to prevent radiation from the radiopharmaceutical from being emitted from the housing.
A delivery system for delivering therapeutic or diagnostic drugs, wherein the delivery system is An injector having a delivery mechanism and an access mechanism, A fluid delivery assembly that is removably connectable to the injector, A storage device for containing the aforementioned therapeutic or diagnostic agent, A fluid cassette that can be fluidly connected to the storage device to access the aforementioned therapeutic or diagnostic agent, A fluid delivery assembly comprising, Equipped with, The aforementioned storage device is A housing with a defined chamber inside, A container placed within the chamber, having an interior configured to receive the therapeutic or diagnostic agent, and an access port for accessing the interior, A door associated with the housing, which is movable between a closed position and an open position relative to the housing via the access mechanism of the injector, and in the closed position covers the opening of the housing to seal the chamber of the housing, and in the open position exposes the opening of the housing to access the access port of the container, Equipped with, The aforementioned fluid cassette is A container access member, a measuring device, and a fluid path set for fluidly connecting the container access member to the measuring device, The container access member, the measuring device, and the housing surrounding the fluid path set, Equipped with, The container access member and the metering device of the fluid cassette are accessible by the delivery mechanism of the injector in order to fluidly connect the inside of the container to the metering device via the fluid path set. Delivery system.

Description

Cross-reference of related applications: This application claims priority to U.S. Provisional Application No. 63/312,145, filed on 21 February 2022, and U.S. Provisional Application No. 63/312,148, filed on 21 February 2022, the disclosures of which are incorporated herein by reference in their entirety. This disclosure relates to systems and methods for packaging, distributing, storing, administering, and/or disposing of radiopharmaceuticals (e.g., radiopharmaceuticals used for therapeutic or imaging purposes). This disclosure further relates to systems and methods for packaging, distributing, storing, administering, and/or disposing of therapeutic or diagnostic agents requiring precise volumetric delivery from a controlled source. Radiopharmaceuticals can be used in targeted radionuclide therapy (TRT) or diagnostic imaging. Radiopharmaceuticals generally consist of a radioisotope (e.g., Ac-255, Lu-177), a targeting moiety or biovector (e.g., an antibody, peptide, antigen, small molecule), and a chelating agent (e.g., DOTA, NOTA, DTPA) optionally linked to each other into a single structure. In some cases, if the radioisotope is something the human body naturally incorporates into tissues or organs, the TRT may consist only of the radioisotope without a biovector or chelating agent. Radiopharmaceuticals are configured to interact with target proteins on cells, such as cancer cells. Radiopharmaceuticals can be mixed in liquid or fluid form. In some examples or embodiments, the radiopharmaceutical may be solid particles entrained in a fluid (e.g., a slurry suitable for infusion into a patient). Administration is generally by intravenous injection into the systemic circulation. Examples of TRT may include targeted alpha therapies (TAT) or targeted beta therapies (TBT). Such therapies may be administered as monotherapy or in combination, for example, by simultaneous or sequential administration. Radioactive therapeutic agents for TAT primarily emit alpha rays. The remainder of the radiation emitted from radioactive therapeutic agents for TAT may include gamma rays and/or beta rays. Radioactive therapeutic agents for TBT primarily emit beta rays. The remainder of the radiation emitted for radioactive therapeutic agents for TBT may include gamma rays and/or alpha rays. Examples of targeted alpha-ray therapy include, but are not limited to, therapies based on thorium (Th-227), actinium (Ac-225), and lead (Pb-212). Examples of targeted beta-ray therapy include therapies based on lutetium (Lu-177), copper (Cu-67), or iodine (I-131). Other examples of radiotherapeutic agents include alpha-ray therapies utilizing radium (Ra) (e.g., the Ra-223 isotope, such as the XOFIGO® therapy offered by Bayer Health Care). The preparation of XOFIGO®, the prepared solutions, and methods for use are described in Patent Document 1, the disclosure of which is incorporated herein by reference in its entirety. The radiopharmaceuticals used in TRT (Therapeutic Remedies) can present significant challenges in their manufacture, storage, distribution, administration, handling, and disposal. Because the therapeutic agents are radioactive, they can cause radiation exposure to human health. Furthermore, considering the decay rate of radiopharmaceuticals, the longer the time elapsed between the manufacture, processing, and delivery to the patient, the less radioactivity will be present in the administered dose. Significant regulations must be followed to safely store and continue to utilize radioactive materials, which can affect how therapeutic agents can be stored and transported, as well as who can use or administer them. For example, such regulations may require care providers to undergo hundreds of hours of training before they can administer any TRT. Figure 1 shows a conventional supply chain for TRT. First, the radiopharmaceutical is manufactured in bulk at a manufacturing facility and loaded into bulk containers. These containers are delivered to a nuclear pharmacy, where a nuclear pharmacist draws a dose based on prescribing work for a specific patient, for example, and places it in a syringe. The patient-ready dose is verified in a dose calibrator at the nuclear pharmacy to validate the prescribed dosing and assay. The dose is calibrated at infusion to ensure it has the necessary activity at the time of infusion. The verified dose is then transported to the treatment site, where it is verified again in a dose calibrator. At the treatment site, the dose must usually be used within a certain time of drawing, before it becomes unsuitable for patient use due to the half-life of the radioactive material. After administration, the used syringe is re-checked with a dose calibrator to verify that the correct prescribed dose was administered to the patient. As shown in Figure 2, the methods for diagnosing, referring, and treating the patient require multiple methods and many different medical professionals. After patient P is diagnosed by phys