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JP-2026514402-A - Radiopharmaceutical delivery system for patient infusion

JP2026514402AJP 2026514402 AJP2026514402 AJP 2026514402AJP-2026514402-A

Abstract

The present invention relates to a theranostics delivery system or radiopharmaceutical delivery system (100) comprising a movable ergonomic workstation (3) having a handle on the side for moving a cart. The radiopharmaceutical delivery system (100) includes a simple design and several enhanced safety features for the user. The delivery system (100) includes a disposable secondary containment system (2) to protect the core workstation from contamination, a configurable dose transporter (6) to enable the safe transport of hot doses between the hot lab and the injection site, and a disposable sealed fluid cartridge (7) for drawing custom volumes from vials or syringes. The delivery system (100) includes a theranostics information science management system comprising a computer screen (19) as a graphical user interface (GUI) with a retractable rotating arm (20) to receive various patient injection parameters and to effectively manage the delivery of desired doses to patients.

Inventors

  • カウフマン ジェームズ エー
  • シウコ ドミニク
  • ナンディ インドラニル

Assignees

  • ジュビラント ドラックスイメージ インコーポレイテッド

Dates

Publication Date
20260511
Application Date
20240328
Priority Date
20230328

Claims (20)

  1. A radiopharmaceutical delivery system (100), (i) A movable cart with an integrated handle, (ii) Information science system with a computer screen (19) configured as a graphical user interface (GUI), (iii) an infusion pump, and (iv) a configurable dose transporter (6), the configurable dose transporter (6) a) Separable radioactive dose transport and containment module (13), b) Shielding for use with one or more different radionuclide types, quantities, and volumes (18) c) a radioactive dose in a syringe (8) or vial (26), and d) a disposable sealed fluid cartridge (7) connected to the syringe (8) or vial (26) by a compression fitting, a delivery system comprising these components.
  2. The delivery system according to claim 1, wherein the syringe (8) may be selected from different standard sizes.
  3. The delivery system according to claim 1, wherein the shield (18) system is configured to be used with syringes of various sizes inserted or connected.
  4. The delivery system according to claim 1, wherein the computer screen (19) serving as a graphical user interface (GUI) has a retractable rotating arm (20).
  5. The delivery system according to claim 1, wherein the disposable sealed fluid cartridge (7) is configured to allow the dispensing of a custom volume from the vial or syringe based on one or more of the patient's weight, sex, age, other physical parameters, or medical history data.
  6. The drug delivery system (100) according to claim 1, wherein the drug delivery system is configured to support drug-specific injection parameters.
  7. The delivery system according to claim 1, wherein the separable radioactive dose transport and containment module (13) is shielded and includes a lead glass observation area (29).
  8. The delivery system according to claim 1, wherein the disposable sealed fluid cartridge (7) is equipped with a corded port for eliminating errors in connecting a patient line or saline line to the cartridge.
  9. The delivery system according to claim 1, wherein the system is configured to monitor or track one or more of the total volume in the syringe, the total volume administered in real time, the total volume from the IV bag, and the total volume injected into the patient.
  10. The delivery system according to claim 1, further comprising a control system for controlling the process of injecting medical fluids into a patient.
  11. The delivery system according to claim 10, wherein the control system is configured to stop the injection process due to a system error.
  12. The delivery system according to claim 1, wherein the system has an audible alarm function to warn the user of the occurrence of one or more of the following: fluid blockage, pump failure, deviation from programmed volume, and a real-time predictive sequence of events.
  13. The delivery system according to claim 1, wherein the shielded infusion pump is configured to protect the patient from air infusion and includes an alarm signal for real-time air detection.
  14. A radiopharmaceutical delivery system (100), (i) A movable cart with at least one handle, (ii) Information science systems with a computer screen (19) as a graphical user interface (GUI), (iii) Injection pump, (iv) a status light system (1) for illuminating a work area for monitoring the injection status, and (v) a configurable dose transporter (6), The configurable dose transporter (6) is a) Separable radioactive dose transport and containment module (13), b) A shield (18) configured to be used with one or more different radionuclide types, quantities, and amounts. c) a radioactive dose in a syringe (8) or vial (26), and d) a disposable sealed fluid cartridge (7) connected to the syringe (8) or vial (26) by a compression fitting, The disposable sealed fluid cartridge is configured to draw a customizable volume from the syringe or vial as part of a delivery system.
  15. The delivery system according to claim 14, wherein the state light system (1) indicates different states of the system with various colors.
  16. The delivery system according to claim 14, wherein the state light system (1) is controlled by a control system.
  17. A radiopharmaceutical delivery system (100), The system comprises a configurable dose transporter (6), a separable radioactive dose transport and containment module (13), a shield (18), a disposable sealed fluid cartridge (7), and a syringe (8) or vial (26), The disposable sealed fluid cartridge (7) is (i) One or more selectable integrated channels (17), (ii) an adapter (9) for fitting the syringe (8) or the vial (26), (iii) a patient port with a code (24) and a saline port (25), and (iv) one or more pressure sensors (27, 28), The disposable sealed fluid cartridge is configured to draw a customizable volume from the syringe or vial as part of a delivery system.
  18. The delivery system according to claim 17, wherein the adapter (9) is tagged with one or more of the following: RFID, barcode, or QR code.
  19. The delivery system according to claim 17, wherein the disposable sealed fluid cartridge (7) is configured to draw a customizable volume based on one or more of the patient's weight, sex, age, medical history data, and/or other physical parameters.
  20. The delivery system according to claim 17, wherein the disposable sealed fluid cartridge (7) is equipped with a corded port to eliminate errors in selecting the patient port and the saline port.

Description

This invention relates to a radiopharmaceutical infusion system. More specifically, the invention relates to a theranostics or radiopharmaceutical delivery system that enables patient infusion of radiopharmaceutical compositions in outpatient clinics and/or hospitals by setting up and pairing a novel syringe shield device in combination with a patient infusion pump device. Radiopharmaceuticals are important for the therapeutic and diagnostic applications of various diseases. The safe and efficient use of these important and potentially hazardous radioisotopes, which have either short or long half-lives, is essential during their intended use by patients and/or healthcare providers. These radioisotopes play a crucial role in the diagnosis and therapy of various diseases. The majority of widely available radiopharmaceuticals are produced by various known technologies. For example, Co-60 is used to treat cancer, I-131 is used to treat hyperthyroidism, C-14 is used in breath tests, Tc-99m and Rb-82 are used as tracers in myocardial perfusion imaging, Ga-68 is used for imaging solid tumors, and Ac-225, Lu-177, and At-211 are used for therapeutic purposes. Due to the short half-lives of some radiopharmaceuticals, the entire imaging and administration procedure must, in essence, be completed within a short time period. Some radiopharmaceuticals are typically prepared at on-site facilities located at a suitable vehicle-accessible distance from the patient's site to prevent excessive decay of the radiopharmaceutical before use. Additionally, these radioisotopes have undesirable radiation-related side effects for users or healthcare providers, as well as patients. Therefore, safe handling techniques, including the use of shielded systems, are essential to avoid various undesirable health hazards. Currently, nuclear medicine technologists configure non-radioactive chemotherapeutic/IV infusion peristaltic pumps for the infusion of theranostic radiopharmaceuticals into patients within hospitals. While diagnostic infusions are of the "bolus" type, in the technology of infusion systems for new generation theranostic/therapeutic radiopharmaceuticals requiring slow infusion (i.e., 1 ml/min), there is an unmet need to provide a safe/shielded delivery system, in addition to minimizing undesirable health damage to patients, users/healthcare providers, and the environment from radiation exposure. Currently available infusion systems and methods have several drawbacks, including the lack of radiation shielding and the inability to flush or wash drug syringes with saline to ensure the correct dose to the patient. Furthermore, current methods do not incorporate syringes; instead, they rely on extended spinal needles to puncture the rubber septum of glass vials to extract the drug, which can lead to the introduction of air into the patient's IV line, resulting in incomplete or inaccurate drug administration and a risk of air embolism in the patient. In addition, not all infusion pumps can accommodate the 60cc syringe volume required for the infusion of some radiopharmaceuticals for therapy. There is an unmet need for infusion system solutions to supply patients with all the necessary specialized radiopharmaceutical procedural supplies, such as ion chambers, Geiger-Müller counters, IV tubes, and radioactive waste. Guidelines regarding the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals have also been published in USP General Chapter <825>. According to the published summary of drug information and standards, customers are prohibited from handling highly radioactive drugs without a cleanroom, and hospitals and pharmacies must comply with these guidelines. This invention facilitates compliance and safety in hospitals and pharmacies by providing quality-controlled drugs in shielded syringes for dose-based patient infusion. More specifically, there is an unmet need to develop an advanced and efficient theranostics delivery system combined with a radiation-shielded syringe infusion pump that can provide increased radiation safety for patients and users/healthcare providers. This is a schematic diagram of a theranostics delivery system or radiopharmaceutical delivery system.This is a schematic diagram of a theranostics delivery system or radiopharmaceutical delivery system.This is a rear view of a theranostics delivery system or radiopharmaceutical delivery system.This is a front view of a theranostics delivery system or radiopharmaceutical delivery system.This is a schematic diagram of a shielded syringe system.This is a schematic diagram of a configurable dose transporter.The figure shows a disposable sealed fluid cartridge including a selectable integrated channel for connecting, for example, a radioisotope dose source and a saline source to an infusion pump and a channel connected to a patient line, for the injection of a desired dose of radioisotope to a patient, wherein the channel allows for bidirectio