Integrated strontium-rubidium radioisotope infusion systems

• US 9,750,869 B2
• Filed: 12/22/2016
• Issued: 09/05/2017
• 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): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US15/389,200
• Publication Number:
  US 20170100535A1
• Time in Patent Office: 257 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. An infusion system on-board a cart comprising:

a cabinet structure that comprises;

a platform,

an exterior shell that extends upwardly above the platform and has a front side;

a rear side;

two sidewalls connecting the front side to the rear side; and

a top surface;

wherein the platform and the exterior shell collectively define an interior space of the cabinet structure and wherein the interior space of the cabinet structure is configured to receive a strontium-rubidium radioisotope generator having an inlet tubing port configured to receive saline and an outlet tubing port configured to discharge a rubidium radioactive eluate,

an opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator within the interior space of the cabinet structure, and

an opening through the top surface of the exterior shell configured to provide access for inserting a waste bottle into or removing the waste bottle from the interior space of the cabinet structure;

a computer with a touch screen display configured to receive an input from a user for controlling operation of the infusion system, wherein the touch screen display is mounted on a vertical post having a top end extending above the cabinet structure;

a first shielding compartment in the interior space of the cabinet structure having a first opening facing vertically upwardly through which the strontium-rubidium radioisotope generator can be inserted into and removed from the first shielding compartment;

a first door accessible via the opening through the exterior shell, the first door being configured to provide access to the first shielding compartment and to close over the first opening;

a second shielding compartment having a second opening facing vertically upwardly through which the waste bottle can be inserted into and removed from the second shielding compartment;

a second door accessible via the opening through the top surface of the exterior shell, the second door being configured to provide access to the second shielding compartment and to close over the second opening;

wherein the first opening is located at a lower elevation than the second opening;

a radioactivity detector positioned to measure radioactivity of the rubidium radioactive eluate flowing through an eluate tubing line in fluid communication with the outlet tubing port of the strontium-rubidium radioisotope generator;

a shielded well on-board the cart configured to receive an eluate reservoir, wherein the eluate reservoir is configured to receive a test sample; and

wherein the computer of the infusion system is configured to;

provide a stop button on the touch screen display to abort a function of the infusion system in response to a user input activating the stop button,

pump saline from a saline reservoir positioned outside of the interior space of the cabinet structure into the strontium-rubidium radioisotope generator through the inlet tubing port of the strontium-rubidium radioisotope generator thereby generating the rubidium radioactive eluate that is discharged through the outlet tubing port,

fill the eluate reservoir in the shielded well on-board the cart with the test sample of the rubidium radioactive eluate,

determine a strontium breakthrough test result on the test sample filled into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart, and

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

2. The infusion system of claim 1, further comprising:

the strontium-rubidium radioisotope generator in the first shielding compartment in the interior space of the cabinet structure, and

the eluate reservoir located in the shielded well on-board the cart and in fluid communication with the eluate tubing line.

3. The infusion system of claim 2, 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.

4. The infusion system of claim 1, wherein the first shielding compartment comprises two tubing passageways formed in a perimeter surface of the first opening, and each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when the first door is closed thereover.

5. The infusion system of claim 1, wherein the opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator within the interior space of the cabinet structure is through the front side of the exterior shell.

6. The infusion system of claim 1, further comprising:

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

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

7. The infusion system of claim 1, wherein access to an operation of the computer is regulated through a user login credential.

8. The infusion system of claim 1, wherein the infusion system is configured to determine the strontium breakthrough test result on the test sample at least once a day.

9. The infusion system of claim 1, wherein the function of the infusion system aborted in response to the user input activating the stop button is a patient infusion procedure.

10. The infusion system of claim 1, further comprising a waste tubing line and a valve, wherein the waste tubing line is in fluid communication with the eluate tubing line and the waste bottle, and the valve is configured to control fluid flow between the eluate tubing line and the waste bottle via the waste tubing line.

11. The infusion system of claim 1, further comprising a hanger configured to hold the saline reservoir at an elevation above the top surface of the exterior shell.

12. The infusion system of claim 1, 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.

13. The infusion system of claim 1, further comprising a dose calibrator in the shielded well on-board the cart and in communication with the computer to determine the strontium breakthrough test result.

14. The infusion system of claim 1, wherein the computer of the infusion system is further configured to track a volume of the saline remaining in the saline reservoir and to alert the user via the touch screen display when the volume of the saline remaining in the saline reservoir is below a predetermined volume threshold.

15. The infusion system of claim 1, wherein the strontium breakthrough test result is for at least one of strontium-82 and strontium-85.

16. The infusion system of claim 1, wherein the computer of the infusion system is further configured to track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle and to control the touch screen display to display a user screen guiding the user to empty the waste bottle.

17. The infusion system of claim 1, wherein the first door is mounted via a hinge and configured to open in an upward direction.

18. The infusion system of claim 1, further comprising:

a USB port to transfer data and a power inlet port for connecting the infusion system to a power source, and

a printer configured to print a document concerning a patient infusion or a quality control test result generated by the infusion system.

19. The infusion system of claim 1, further comprising a light projector mounted on the top end of the vertical post extending above the cabinet structure, wherein the light projector is configured to:

project a first light signal to indicate that an elution is taking place, and

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

20. The infusion system of claim 1, wherein the exterior shell further includes a saline tubing opening configured for a saline tubing line to pass from the saline reservoir outside of the exterior shell to the interior space of the cabinet structure.

21. The infusion system of claim 1, wherein the computer of the infusion system is further configured to pump saline through the strontium-rubidium radioisotope generator at a rate less than approximately 70 ml/min.

22. The infusion system of claim 1, further comprising an electrical connector port accessible through an electrical connector port opening on the exterior shell and configured to place the infusion system in communication with at least one of an intranet network, an internet network, and a device used for a nuclear imaging procedure.

23. The infusion system of claim 1, further comprising:

a front cover that is movable relative to the exterior shell to close the opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator, and

a top cover that is movable relative to the exterior shell to close the opening through the top surface of the exterior shell.

24. The infusion system of claim 1, further comprising:

a hanger configured to hold the saline reservoir at an elevation above the top surface of the exterior shell,

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

four wheels mounted to an underside of the platform,

a power inlet port for connecting the infusion system to a power source, and

a printer configured to print a document concerning a patient infusion or a quality control test result generated by the infusion system;

wherein;

the first shielding compartment comprises two tubing passageways formed in a perimeter surface of the first opening,

each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when the first door is closed thereover,

the first door is mounted via a hinge,

access to an operation of the computer is regulated through a user login credential,

the strontium breakthrough test result is for at least one of strontium-82 and strontium-85, and

the exterior shell further includes a saline tubing opening configured for a saline tubing line to pass from the saline reservoir outside of the exterior shell to the interior space of the cabinet structure; and

wherein the computer of the infusion system is further configured to;

determine the strontium breakthrough test result on the test sample at least once a day,

pump saline through the strontium-rubidium radioisotope generator at a rate less than approximately 70 ml/min,

track a volume of the rubidium radioactive eluate discharged from the strontium-rubidium radioisotope generator to the waste bottle and to control the touch screen display to display a user screen guiding the user to empty the waste bottle, and

track a volume of the saline remaining in the saline reservoir and to alert the user via the touch screen display when the volume of the saline remaining in the saline reservoir is below a predetermined volume threshold.

25. The infusion system of claim 24, wherein the infusion system further comprises:

the strontium-rubidium radioisotope generator with the inlet tubing port configured to receive saline and the outlet tubing port configured to discharge the rubidium radioactive eluate;

a light projector mounted on the top end of the vertical post extending above the cabinet structure, wherein the light projector is configured to;

project a first light signal to indicate that an elution is taking place, and

project a second light signal to indicate that a peak bolus of radioactivity is detected;

the eluate reservoir located inside the shielded well on-board the cart and in fluid communication with the eluate tubing line;

a waste tubing line in fluid communication with the eluate tubing line and the waste bottle;

a valve configured to control fluid flow between the eluate tubing line and the waste bottle via the waste tubing line; and

a pedal configured to brake at least one of the four wheels when the pedal is depressed.

26. The infusion system of claim 25, 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.

27. The infusion system of claim 24, further comprising a dose calibrator located in the shielded well on-board the cart and in communication with the computer, wherein the dose calibrator is configured to determine the strontium breakthrough test result;

and

wherein the opening through the exterior shell configured to provide access to the strontium-rubidium radioisotope generator within the interior space of the cabinet structure is through the front side of the exterior shell.

28. The infusion system of claim 27, further comprising:

the strontium-rubidium radioisotope generator with the inlet tubing port configured to receive saline and the outlet tubing port configured to discharge the rubidium radioactive eluate,

the eluate reservoir located inside the shielded well on-board the cart and in fluid communication with the eluate tubing line,

a waste tubing line in fluid communication with the eluate tubing line and the waste bottle, and

a valve configured to control fluid flow between the eluate tubing line and the waste bottle via the waste tubing line.

29. The infusion system of claim 28, wherein the computer of the infusion system is configured to:

measure an activity of the test sample filled into the eluate reservoir in the shielded well on-board the cart while the eluate reservoir remains in the shielded well on-board the cart, wherein the activity is measured with the dose calibrator in the shielded well on-board the cart, and

calibrate the infusion system based on the activity measured by the dose calibrator.

30. The infusion system 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.