INFUSION SYSTEMS INCLUDING COMPUTER-FACILITATED MAINTENANCE AND/OR OPERATION AND METHODS OF USE

• US 20090312630A1
• Filed: 06/11/2008
• Published: 12/17/2009
• Est. Priority Date: 06/11/2008
• Status: Active Grant

• Current Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Original Assignee: Bracco Diagnostics Incorporated (Bracco SPA)
• Inventors: Gelbach, Janet L., Hidem, Stephen E., McDonald, Patrick M., Fontaine, Aaron M., Hunter, Kathryn M.
• Granted Patent: US 9,597,053 B2
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 2090/392 Radioactive markers
• 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 6/582 Calibration
• CPC Class Codes: A61K 51/00 Preparations containing radioactive substances for use in therapy or testing in vivo
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2209/08 Supports 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 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• 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 includes 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 parameters for quality control, and/or to perform purges of the system.

Claims

1. A method for operating an infusion system, the system comprising an eluant reservoir, a pump coupled to the reservoir, an infusion tubing circuit, a radioisotope generator, an activity detector, a waste bottle and a computer including a computer interface, the infusion tubing circuit including an eluant line coupled to the pump and to the generator, a waste line coupled to the generator and to the waste bottle, and a patient line coupled to the generator, the method comprising:

entering, into the computer, via the computer interface, a command to activate the pump in order to generate an eluate from a portion of a volume of eluant pumped through the generator, via an elution within the generator;

receiving an indication, from the computer, via the computer interface, that the elution is completed, when the pump has completed pumping the portion of the volume of eluant; and

receiving an indication, from the computer, via the computer interface, of time lapsed since the elution was completed.

2. The method of claim 1, further comprising:

entering, into the computer, via a computer interface, the volume of eluant contained in the reservoir, prior to the elution; and

receiving, from the computer interface, an indication of a volume of eluant in the reservoir, based upon tracking the portion of the volume of eluant that is pumped from the reservoir.

3. The method of claim 1, further comprising:

coupling the patient line of the infusion tubing circuit to a first shielded test vial, in order to collect a first sample of the eluate from the patient line during the elution;

measuring an activity of the first sample; and

entering into the computer, via the computer interface, the measured activity of the first sample and a time between completion of the elution and the measuring of the activity so that the computer may calculate a breakthrough of the generator.

4. The method of claim 3, further comprising:

selecting a breakthrough test procedure of the computer, via the computer interface, prior to entering the command to activate the pump; and

wherein coupling the patient line to the first shielded test vial is instructed by the computer interface, after selecting the breakthrough test.

5. The method of claim 3, further comprising:

exchanging the patient line of the infusion tubing circuit for a first new patient line, after collecting the first sample;

coupling the first new patient line to a second shielded test vial;

repeating the steps of claim 1, after exchanging the patient line, wherein the pump is activated a second time and a second elution takes place, in order to fill the second vial with a second sample of the eluate from the first new patient line;

measuring an activity of the second sample; and

entering into the computer, via the computer interface, the measured activity of the second sample and a time between completion of the second elution and the measuring of the activity of the second sample, so that the computer may calculate a calibration coefficient for the infusion system based on the measured activity of the second sample and an activity of the eluate detected, during the second elution, by the activity detector of the system.

6. The method of claim 5, further comprising:

selecting a calibration procedure of the computer, via the computer interface, prior to entering the command to activate the pump for the second time; and

wherein coupling the first new patient line to the second shielded test vial is instructed by the computer interface, after selecting the calibration procedure.

7. The method of claim 5, further comprising:

exchanging the first new patient line of the infusion tubing circuit for a second new patient line, after the computer calculates the calibration coefficient;

purging air from the second patient line;

coupling the second new patient line to a patient, after purging; and

repeating the steps of claim 1, after exchanging the first new patient line for the second new patient line, wherein the pump is activated a third time and a third elution takes place, in order to inject a dose of the eluate to the patient from the second patient line.

8. The method of claim 7, further comprising receiving a report from the computer, upon completion of the third elution, the report including a patient identification number and at least one quantification of the dose of the eluate.

9. The method of claim 1, further comprising:

coupling the patient line to a shielded test vial in order to collect a sample of the eluate from the patient line during the elution;

measuring an activity of the sample; and

entering into the computer, via the computer interface, the measured activity of the sample and a time between completion of the elution and measuring of the activity, so that the computer may calculate a calibration coefficient for the infusion system based on the measured activity and an activity of the eluate detected, during elution, by the activity detector of the system.

10. The method of claim 9, further comprising:

selecting a calibration procedure of the computer, via the computer interface, prior to entering the command to activate the pump; and

wherein coupling the patient line to the shielded test vial is instructed by the computer interface, after selecting the calibration procedure.

11. The method of claim 1, further comprising:

purging air from the patient line;

coupling the patient line to a patient, after purging, in order to inject a dose of the eluate to the patient from the patient line; and

receiving a report from the computer, upon completion of the elution, the report including a patient identification number and at least one quantification of the dose of the eluate.

12. The method of claim 1, wherein the computer interface comprises a touch-activated display screen.

13. The method of claim 1, further comprising:

receiving an indication, from the system, that the eluate is being diverted, from the generator, through the waste line of the infusion tubing circuit, when the pump is activated;

receiving an indication, from the system, that the eluate is being diverted from the generator, through the patient line of the infusion tubing circuit, when the pump is activated;

14. The method of claim 13, wherein:

the system further comprises a light projector;

the indication that the eluate is being diverted through the waste line comprises a flashing light projection from the light projector; and

the indication that the eluate is being diverted through the patient line comprises a solid light projection from the light projector.

15. The method of claim 13, further comprising receiving an indication from the system that a peak bolus of radioactivity has been detected, in the eluate, by the activity detector.

16. The method of claim 15, wherein:

the system further comprises a light projector; and

the indication that the peak bolus of radioactivity has been detected comprises a flashing light from the light projector.

17. The method of claim 1, further comprising:

entering, into the computer, via the computer interface, a command to set a waste bottle level indicator to zero, when the waste bottle is empty and prior to entering the command to activate the pump; and

receiving, from the computer, via the computer interface, an indication that the waste bottle needs to be emptied, based upon the computer tracking a volume of the eluate that is diverted, from the generator, through the waste line of the infusion tubing circuit.

18. A computer readable medium having computer executable instructions for executing a method for maintaining an infusion system, the method comprising:

receiving, via a graphical user interface, a volume of eluant contained in a reservoir of the infusion system prior to activating a pump of the infusion system to pump a portion of the volume of eluant through a radioisotope generator of the system in order to generate, via elution, an eluate;

tracking the portion of the volume of eluant that is pumped from the reservoir;

providing an indication of a volume of eluant within the reservoir; and

tracking a volume of the eluate that is diverted from the generator to the waste bottle;

providing an indication that the waste bottle needs to be emptied.

19. The computer readable medium of claim 18, further including receiving, via the graphical user interface, a command to set a waste bottle level indicator to zero when the waste bottle is empty.

20. A computer readable medium having computer executable instructions for executing a method of calibrating an activity detector of an infusion system, the method comprising:

receiving a calibration command;

receiving calibration parameters relating to an elution process;

activating a pump of the infusion system to initiate the elution process, the elution process producing a sample of an eluate;

tracking a time from the end of the elution process;

receiving from the activity detector of the infusion system an activity level detected during the elution process;

receiving a measured activity level of the eluate sample obtained from a dose calibrator;

receiving a time measured from the completion of the elution process to the measurement of the activity level by the dose calibrator;

calculating a calibration coefficient for the infusion system based on the measured activity level of the eluate sample and activity level detected during the elution process; and

providing the calibration coefficient as an output.

21. A computer readable medium having computer executable instructions for executing a method of conducting a breakthrough test of a radioisotope generator of an infusion system, the method comprising:

receiving a breakthrough test command;

activating a pump of the infusion system to initiate an elution process, the elution process using the generator to produce a sample of an eluate from a patient line;

tracking a time lapsed from the end of the elution process;

receiving a measured activity level of the eluate sample obtained from a dose calibrator;

receiving a time measured from the completion of the elution process to the measurement of the activity level by the dose calibrator;

calculating a breakthrough of the radioisotope generator based on the measured activity level and the time between completion of the elution process and the measuring of the activity level; and

providing the breakthrough of the generator as an output.

22. The computer readable medium of claim 21, further comprising:

receiving a second measured activity level of the eluate sample obtained from a dose calibrator, the second measured activity level being a measurement taken at predetermined time period after the completion of the elution process.

23. The computer readable medium of claim 21, wherein the predetermined time period is 60 minutes after completion of the elution process.

24. A method for purging a tubing circuit of an infusion system with air, the system comprising a pump coupled to the tubing circuit, a radioisotope generator, a waste bottle and a computer including a computer interface, the method comprising:

receiving instructions from the computer, via the computer interface, to disconnect the pump from an eluant reservoir of the system, and to by-pass the generator by disconnecting an eluant line and an eluate line, of the tubing circuit, from the generator, and connecting the eluant line to the eluate line; and

entering, into the computer, via the computer interface, a command to perform an air purge of the tubing circuit, the air purge being automated, via the computer, to perform purges of individual portions of the tubing circuit, in sequence, via control of the pump and of two divergence valves of the tubing circuit;

wherein a first valve, of the two divergence valves, is located between a first portion of the eluate line and two downstream portions of the eluate line, a first of the two downstream portions extending to a waste bottle of the system and a second of the two downstream portions extending to a vial outside the system;

a second valve, of the two divergence valves, is located between a first portion of the eluant line, extending from the pump, and two downstream portions of the eluant line, a first of the two downstream portions of the eluant line being connected to the first portion of the eluate line, and a second of the two downstream portions of the eluant line being connected to the second of the two downstream portions of the eluate line.