Methods and systems for integrated radiopharmaceutical generation, preparation, transportation and administration

• US 10,016,618 B2
• Filed: 04/29/2016
• Issued: 07/10/2018
• Est. Priority Date: 01/01/2007
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Hirschman, Alan D., Uber, III, Arthur E., Reilly, David M., Kalafut, John F., Trombley, III, Frederick W., Remis, Steven J., Griffith, Scott, Descalzi, Douglas, Dewit, Richard, Griffiths, David M., Mabie, Marc A., Trocki, Mark
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US15/142,000
• Publication Number:
  US 20160303397A1
• Time in Patent Office: 802 Days
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/7289 Retrospective gating, i.e. associating measured signals or images with a physiological event after the actual measurement or image acquisition, e.g. by simultaneously recording an additional physiological signal during the measurement or image acquisition
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 6/0478 Chairs
• CPC Class Codes: A61B 6/107 Protection against radiation, e.g. shielding
• CPC Class Codes: A61B 6/4057 by using radiation sources located in the interior of the body A61B6/037 takes precedence
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/4423 related to hygiene or sterilisation
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61B 6/508 for non-human patients
• CPC Class Codes: A61B 6/5288 involving retrospective matching to a physiological signal
• CPC Class Codes: A61B 6/548 Remote control of the apparatus or devices
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/1785 : comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: A61N 2005/1021 : Radioactive fluid
• CPC Class Codes: A61N 2005/1094 : Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1001 : using radiation sources introduced into or applied onto the body; brachytherapy
• CPC Class Codes: A61N 5/1071 : for verifying the dose delivered by the treatment plan
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G21F 5/015 : for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers
• CPC Class Codes: G21G 4/08 : specially adapted for medical application radiation therapy using radioactive sources A61N5/10

Abstract

An integrated radiopharmaceutical patient treatment system is disclosed including a patient support platform with an associated patient stimulus apparatus, an imager proximate the patient support platform, a radiopharmaceutical fluid delivery system for infusing a radiopharmaceutical fluid into a patient, a patient monitor to be associated with a patient, and an integrated system controller operably associated with the patient stimulus apparatus, imager, radiopharmaceutical fluid delivery system, and patient monitor to control and coordinate their operations. Within the patient treatment system the radiopharmaceutical fluid delivery system may be included comprising a radionuclide supply module, a radiopharmaceutical processing module, a quality control module, a patient injection module, and a controller. A hazardous fluid handling system including a docking station and a hazardous fluid transport device adapted to detachably dock with the docking station is further disclosed.

Claims

1. A hazardous fluid handling system comprising:

a pump;

a pump control device electronically linked to the pump;

a user interface wirelessly coupled to the pump control device;

a radiation shielded internal chamber disposed within a housing and configured to hold a container having a radioactive fluid contained therein and having a known internal geometry;

at least two radioactivity detectors positioned within the shielded internal chamber in operational proximity to the radioactive fluid in the container; and

a dosimeter control device electronically coupled to each of the at least two radioactivity detectors,

wherein the dosimeter control device is operational for determining information on a fill volume of the radioactive fluid in the container based on individual measurements received from the at least two radioactivity detectors, and

wherein the dosimeter control device is configured to use the individual measurements received from the at least two radioactivity detectors for determining error information comprising at least one of a presence of bubbles in the container and a presence of spills or leaks of the radioactive fluid from the container.

2. The hazardous fluid handling system of claim 1, wherein the dosimeter control device is electronically linked to the pump control device.

3. The hazardous fluid handling system of claim 1, further comprising a data recording device electronically linked to the dosimeter control device.

4. The hazardous fluid handling system of claim 1, further comprising a communications interface electronically linked to the pump control device.

5. The hazardous fluid handling system of claim 4, wherein the communications interface is configured to wirelessly link to an information network.

6. The hazardous fluid handling system of claim 1, further comprising a fluid path in fluid communication with the pump.

7. The hazardous fluid handling system of claim 1, wherein the user interface is a handheld user interface wirelessly coupled to the pump control device.

8. The hazardous fluid handling system of claim 1, wherein the hazardous fluid handling system is integrated into a patient support platform.

9. The hazardous fluid handling system of claim 8, wherein the patient support platform comprises:

a patient stimulus apparatus;

an imager proximate the patient support platform;

a radiopharmaceutical fluid delivery system for infusing the radiopharmaceutical fluid into a patient;

a patient monitor to be associated with the patient; and

an integrated system controller operably associated with the patient stimulus apparatus, the imager, the radiopharmaceutical fluid delivery system, and the patient monitor.

10. The hazardous fluid handling system of claim 1, wherein the dosimeter control device receives a signal from each of the at least two radioactivity detectors and is capable of determining an activity of the radioactive fluid in the container.

11. The hazardous fluid handling system of claim 1, wherein each of the at least two radioactivity detectors are positioned at a different vertical location relative to the shielded internal chamber.

12. The hazardous fluid handling system of claim 1, further comprising at least one position sensor, wherein the dosimeter control device is operational for determining the fill volume and one or more additional property of the system based on individual measurements received from the at least two radioactivity detectors and the at least one position sensor.

13. A hazardous fluid handling system comprising:

a pump;

a pump control device electronically linked to the pump;

a user interface wirelessly coupled to the pump control device;

a radiation shielded internal chamber disposed within a housing and configured to hold a container having a radioactive fluid contained therein and having a known internal geometry;

at least one radioactivity detector positioned within the shielded internal chamber in operational proximity to detect radiation emitted by the radioactive fluid in the container;

a position sensor; and

a dosimeter control device electronically coupled with the at least one radioactivity detector and the position sensor,

wherein the dosimeter control device is operational for determining an activity of the radioactive fluid in the container based on measurements received from the at least one radioactivity detector and the position sensor, and

wherein the dosimeter control device is configured to use individual measurements received from the at least one radioactivity detector and the position sensor for determining error information comprising at least one of a presence of bubbles in the container and a presence of spills or leaks of the radioactive fluid from the container.

14. The hazardous fluid handling system of claim 13, further comprising a data recording device electronically linked to the dosimeter control device.

15. The hazardous fluid handling system of claim 13, wherein the dosimeter control device receives a signal from at least two radioactivity detectors and the position sensor and is capable of determining the activity of the radioactive fluid in the container and at least one additional property of the system.

16. The hazardous fluid handling system of claim 13, wherein the dosimeter control device is electronically linked to the pump control device.

17. The hazardous fluid handling system of claim 16, further comprising a communications interface electronically linked to the pump control device and wirelessly linked to an information network.

18. The hazardous fluid handling system of claim 13, wherein the user interface is a handheld user interface wirelessly coupled to the pump control device.

19. The hazardous fluid handling system of claim 13, wherein the hazardous fluid handling system is integrated into a patient support platform.

20. The hazardous fluid handling system of claim 19, wherein the patient support platform comprises:

a patient stimulus apparatus;

an imager proximate the patient support platform;

a radiopharmaceutical fluid delivery system for infusing the radiopharmaceutical fluid into a patient;

a patient monitor to be associated with the patient; and

an integrated system controller operably associated with the patient stimulus apparatus, the imager, the radiopharmaceutical fluid delivery system, and the patient monitor.