Integrated Strontium-Rubidium radioisotope infusion systems

• US 10,376,630 B2
• Filed: 10/03/2018
• Issued: 08/13/2019
• Est. Priority Date: 06/11/2008
• Status: Active Grant

• Current Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Original Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Inventors: Hidem, Stephen E., Fontaine, Aaron M., Gelbach, Janet L., McDonald, Patrick M., Hunter, Kathryn M., Swenson, Rolf E., Zodda, Julius P.
• Primary Examiner(s): Dorna, Carrie R
• Application Number:
  US16/150,702
• Publication Number:
  US 20190060558A1
• Time in Patent Office: 314 Days
• CPC Class Codes: A61B 2050/105 Cabinets
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 6/107 Protection against radiation, e.g. shielding
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 51/00 Preparations containing radioactive substances for use in therapy or testing in vivo
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1409 : in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16854 : by monitoring line pressure
• CPC Class Codes: A61M 5/16881 : Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61N 2005/1021 : Radioactive fluid
• CPC Class Codes: A61N 2005/1022 : Generators, e.g. X-ray tubes
• CPC Class Codes: A61N 2005/1074 : Details of the control system, e.g. user interfaces
• 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 5/1007 : Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1075 : for testing, calibrating, or quality assurance of the radiation treatment apparatus
• CPC Class Codes: B62B 3/005 : Details of storage means, e.g. drawers, bins or racks
• CPC Class Codes: G06F 21/31 : User authentication
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: G21F 3/00 : Shielding characterised by its physical form, e.g. granules, or shape of the material
• CPC Class Codes: G21F 7/00 : Shielded cells or rooms
• CPC Class Codes: G21G 1/0005 : Isotope delivery systems use of radioisotopes as tracers G21H5/02
• CPC Class Codes: G21G 1/001 : Recovery of specific isotopes from irradiated targets
• CPC Class Codes: G21G 2001/0031 : Rubidium
• CPC Class Codes: G21G 4/08 : specially adapted for medical application radiation therapy using radioactive sources A61N5/10

Abstract

Methods for setting up, maintaining and operating a radiopharmaceutical infusion system, that includes a radioisotope generator, are facilitated by a computer of the system. The computer may include pre-programmed instructions and a computer interface, for interaction with a user of the system, for example, in order to track contained volumes of eluant and/or eluate, and/or to track time from completion of an elution performed by the system, and/or to calculate one or more system and/or injection parameters for quality control, and/or to perform purges of the system, and/or to facilitate diagnostic imaging.

Claims

1. A method of building an infusion system to deliver a rubidium radioactive eluate comprising:

installing on a cart a first shielding compartment having a first opening, a second shielding compartment having a second opening, and a shielded well, wherein;

the first opening is configured for a strontium-rubidium radioisotope generator to be inserted into and removed from the first shielding compartment,

the second opening is configured for a waste bottle to be inserted into and removed from the second shielding compartment, and

the shielded well is configured to receive an eluate reservoir, the eluate reservoir being configured to receive a sample of the rubidium radioactive eluate;

configuring a computer for the infusion system to;

collect the sample of the rubidium radioactive eluate in the eluate reservoir by pumping saline from a saline reservoir into the strontium-rubidium radioisotope generator via a saline tubing line thereby generating the rubidium radioactive eluate that is discharged through an eluate tubing line,

determine a strontium breakthrough test result on the sample of the rubidium radioactive eluate collected in the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart,

not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit,

track a volume of saline in the saline reservoir,

not allow a patient infusion if the volume of saline in the saline reservoir is below a predetermined saline threshold,

track a volume of a waste in the waste bottle, and

not allow a patient infusion if the volume of waste in the waste bottle is above a predetermined waste threshold.

2. The method of claim 1, wherein the computer is further configured to:

provide an alert via a display of the computer when the volume of saline in the saline reservoir is below a predetermined volume threshold.

3. The method of claim 1, wherein the computer is further configured to:

provide an indication when the waste bottle needs to be emptied.

4. The method of claim 3, wherein the indication is a screen on a display of the computer reminding a user to empty the waste bottle.

5. The method of claim 1, wherein the computer is further configured to:

receive an input from a user indicating that the waste bottle has been emptied.

6. The method of claim 1, wherein the infusion system further comprises a saline sensor on the cart in communication with the computer to track the volume of saline in the saline reservoir.

7. The method of claim 1, wherein configuring the computer to track the volume of saline in the saline reservoir comprises configuring the computer to track depletion of the saline reservoir from a baseline volume via activations of a pump on the cart.

8. The method of claim 1, wherein the infusion system further comprises a waste sensor on the cart in communication with the computer to track the volume of the waste in the waste bottle.

9. The method of claim 1, wherein configuring the computer to track the volume of waste in the waste bottle comprises configuring the computer to track a filling of the waste bottle via activations of a pump on the cart.

10. The method of claim 1, wherein the computer is further configured to:

determine a radioactivity of the sample of the rubidium radioactive eluate while the sample is flowing through the eluate tubing line to the eluate reservoir;

determine a calibration radioactivity of the sample while the sample remains in the eluate reservoir in the shielded well on-board the cart; and

compare the radioactivity of the sample determined while flowing through the eluate tubing line with the calibration radioactivity of the sample determined in the eluate reservoir in the shielded well on-board the cart.

11. The method of claim 1, wherein the computer is further configured to:

control a fluid communication between the strontium-rubidium radioisotope generator and the saline reservoir,

control a fluid communication between the eluate tubing line and the eluate reservoir when the eluate tubing line is connected with the eluate reservoir,

control a fluid communication between the eluate tubing line and the waste bottle,

control a fluid communication between the eluate tubing line and a patient when the eluate tubing line is connected with the patient,

pump a dose of the rubidium radioactive eluate to the patient; and

flush the rubidium radioactive eluate remaining in at least a portion of the eluate tubing line into the patient by pumping saline from the saline reservoir to the eluate tubing line through a by-pass line that by-passes the strontium-rubidium radioisotope generator.

12. The method of claim 1, wherein the cart comprises a platform and an exterior shell extending upwardly above the platform, wherein:

the exterior shell comprises a front side;

a rear side;

two sidewalls; and

a top surface,

the platform and the exterior shell collectively define an interior space of a cabinet structure,

the cabinet structure has a lowermost portion and the platform has a lower surface,

the first opening is at a first elevation,

the second opening is at a second elevation,

the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and

the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.

13. The method of claim 1, wherein the infusion system is configured for the saline tubing line and the eluate tubing line to be routed through at least one tubing passageway formed in a perimeter surface of the first shielding compartment, wherein the at least one tubing passageway has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough.

14. The method of claim 1, wherein the infusion system comprises a dose calibrator in the shielded well on-board the cart, wherein the dose calibrator is in communication with the computer to determine the strontium breakthrough test result.

15. The method of claim 1, wherein the computer is further configured to allow a user to:

log into the computer by entering a user login credential on a display of the computer,

transfer a patient infusion record via a USB port, and

print a document concerning the patient infusion or the strontium breakthrough test result via a printer.

16. The method of claim 1, wherein the computer is further configured to allow a user to:

initiate a generator column wash through a display of the computer, wherein a predetermined amount of saline is pumped through the strontium-rubidium radioisotope generator and directed to the waste bottle during the generator column wash.

17. The method of claim 1, wherein the computer is further configured to allow a user to:

initiate a purging process through a display of the computer to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.

18. The method of claim 1, wherein the computer is further configured for a user to:

enter a patient ID on a display of the computer,

enter a patient dose on the display of the computer, and

enter a flow rate on the display of the computer.

19. The method of claim 1, wherein the computer is further configured to present on a display of the computer a screen for starting the patient infusion.

20. The method of claim 1, wherein the infusion system further comprises:

a handle configured for a user to grasp in order to move the infusion system, and

four wheels mounted to an underside of the cart.

21. The method of claim 1, wherein the computer is further configured to:

present on a display of the computer a screen for starting the patient infusion;

present on the display of the computer a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart;

present on the display of the computer a screen indicating that the patient infusion is in process,

present on the display of the computer a stop button to abort the patient infusion when the patient infusion is in process; and

present on the display of the computer the strontium breakthrough test result.

22. The method of claim 21, wherein the computer is further configured to allow the user to:

log into the computer by entering a user login credential on the display of the computer,

enter a patient ID on the display of the computer,

enter a patient dose on the display of the computer, and

enter a flow rate on the display of the computer.

23. The method of claim 22, wherein the computer is further configured to:

track time passed from completion of pumping the sample of the rubidium radioactive eluate into the eluate reservoir to measuring the strontium breakthrough test result,

provide an alert via the display of the computer when the volume of saline in the saline reservoir is below a predetermined volume threshold, and

present on the display of the computer a screen reminding the user to empty the waste bottle.

24. The method of claim 23, wherein the computer is further configured to allow the user to:

initiate a generator column wash through the display of the computer, wherein a predetermined amount of saline is pumped through the strontium-rubidium radioisotope generator and directed to the waste bottle during the generator column wash, and

initiate a purging process through the display of the computer to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.

25. The method of claim 24, wherein the infusion system is configured for the saline tubing line and the eluate tubing line to be routed through at least one tubing passageway formed in a perimeter surface of the first shielding compartment, wherein the at least one tubing passageway has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough.

26. The method of claim 25, wherein the infusion system further comprises:

the strontium-rubidium radioisotope generator in the first shielding compartment,

a platform having an underside,

an exterior shell extending upwardly above the platform, wherein the platform and the exterior shell collectively define an interior space of a cabinet structure,

a handle configured for the user to grasp in order to move the infusion system, and

four wheels mounted to the underside of the platform of the cabinet structure.

27. The method of claim 26, wherein the computer is further configured to:

project a first light signal from a light projector mounted on a top end of a vertical post extending above the cabinet structure to indicate that an elution is taking place, and

project a second light signal from the light projector to indicate that a peak bolus of radioactivity is detected.

28. The method of claim 27, wherein

the cabinet structure has a lowermost portion and the platform has a lower surface,

the first opening is at a first elevation,

the second opening is at a second elevation,

the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and

the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.

29. The method of claim 26, wherein the infusion system further comprises a dose calibrator in the shielded well on-board the cart and wherein the dose calibrator is in communication with the computer to determine the strontium breakthrough test result.

30. The method of claim 29, wherein

the cabinet structure has a lowermost portion and the platform has a lower surface,

the first opening is at a first elevation,

the second opening is at a second elevation,

the first elevation is between approximately 1 foot and approximately 2 feet, with respect to the lowermost portion of the cabinet structure, and

the second elevation is between approximately 2 feet and approximately 3 feet, with respect to the lower surface of the platform.