# US 9,750,870 B2 · Integrated strontium-rubidium radioisotope infusion systems

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- Number: US 9,750,870 B2
- Document ID: US9750870B2
- Status: Granted
- Kind: B2
- Application number: 15/490,484
- Filed: 2017-04-18
- Published: 2017-08-10
- Granted: 2017-09-05
- Earliest claimed: 2008-06-11
- Assignees: Bracco Diagnostics Inc.
- Applicants: Bracco Diagnostics Inc.
- Inventors: Stephen E. Hidem; Aaron M. Fontaine; Janet L. Gelbach; Patrick M. McDonald; Kathryn M. Hunter; Rolf E. Swenson; Julius P. Zodda
- Web page: https://patentgrep.com/patent/US9750870B2

## CPC

- A61M 5/007: {for contrast media}
- A61B 6/037: {Emission tomography}
- A61B 6/107: {Protection against radiation, e.g. shielding}
- A61B 6/481: {involving the use of contrast agents}
- A61B 6/507: {for determination of haemodynamic parameters, e.g. perfusion CT}
- A61B 50/13: Trolleys{, e.g. carts}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61K 51/00: Preparations containing radioactive substances for use in therapy or testing in vivo
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/1452: {pressurised by means of pistons}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/16854: {by monitoring line pressure}
- A61M 5/16881: {Regulating valves}
- A61M 5/365: {Air detectors (A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626)}
- A61N 5/1001: {using radiation sources introduced into or applied onto the body; brachytherapy}
- A61N 5/1007: {Arrangements or means for the introduction of sources into the body}
- A61N 5/1075: {for testing, calibrating, or quality assurance of the radiation treatment apparatus}
- G06F 21/31: User authentication
- G16H 20/17: delivered via infusion or injection
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- G21F 3/00: Shielding characterised by its physical form, e.g. granules, or shape of the material
- G21F 7/00: Shielded cells or rooms
- G21G 1/0005: {Isotope delivery systems (use of radioisotopes as tracers G21H5/02)}
- G21G 1/001: {Recovery of specific isotopes from irradiated targets}
- G21G 4/08: specially adapted for medical application (radiation therapy using radioactive sources A61N5/10)
- A61B 2050/105: {Cabinets}
- A61B 2090/392: {Radioactive markers}
- A61M 5/1409: {in series, e.g. reconstitution systems with a first substance passing through a container holding a second substance}
- A61M 2005/1403: {Flushing or purging}
- A61M 2205/18: with alarm
- A61M 2205/276: preventing unwanted use
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/50: with microprocessors or computers
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/584: having a color code
- A61M 2205/587: Lighting arrangements
- A61M 2205/6009: for matching patient with his treatment, e.g. to improve transfusion security
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/6072: Bar codes
- A61M 2205/70: with testing or calibration facilities
- A61M 2205/75: with filters
- A61M 2209/084: Supporting bases, stands for equipment
- A61N 2005/1021: {Radioactive fluid}
- A61N 2005/1022: {Generators, e.g. X-ray tubes}
- A61N 2005/1074: {Details of the control system, e.g. user interfaces}
- A61N 2005/1094: {Shielding, protecting against radiation}
- B62B 3/005: {Details of storage means, e.g. drawers, bins or racks}
- G21G 2001/0031: {Rubidium}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
- G21F: PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR (radiation protection by pharmaceutical means A61K8/00, A61Q17/04; in cosmonautic vehicles B64G1/54; combined with a reactor G21C11/00; combined with X-ray tubes H01J35/16; combined with X-ray apparatus H05G1/02)
- G21G: CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES (applications of radiation in general G21H5/00; handling particles, e.g. neutrons, or electromagnetic radiation not otherwise provided for G21K)
- B62B: HAND-PROPELLED VEHICLES, e.g. HAND CARTS OR PERAMBULATORS; SLEDGES (characterised by animal propulsion B62C; propulsion of sledges by driver or engine B62M)

## 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

### Claim 1

A method of using an infusion system on-board a cart to deliver a rubidium radioactive eluate comprising:
installing a saline reservoir on the infusion system, wherein the infusion system comprises a platform and an exterior shell extending upwardly above the platform, and wherein the platform and the exterior shell collectively define an interior space of a cabinet structure;
placing the saline reservoir in fluid communication through a saline tubing line with an inlet tubing port of a strontium-rubidium radioisotope generator located in a first shielding compartment in the interior space of the cabinet structure, wherein the strontium-rubidium radioisotope generator further comprises an outlet tubing port configured to discharge the rubidium radioactive eluate, and wherein the first shielding compartment has a first opening facing vertically upwardly;
inserting a waste bottle into a second shielding compartment on-board the cart, wherein the second shielding compartment on-board the cart has a second opening facing vertically upwardly and being at a higher elevation than the first opening;
placing the waste bottle in fluid communication with the outlet tubing port of the strontium-rubidium radioisotope generator through an eluate tubing line, wherein a computer on-board the cart is configured to control the fluid communication between the waste bottle and the outlet tubing port, and wherein the computer has a touch screen display mounted on a vertical post with a top end extending above the cabinet structure;
inserting an eluate reservoir in a shielded well on-board the cart;
placing the eluate reservoir in fluid communication with the eluate tubing line, wherein the computer is further configured to control the fluid communication between the eluate reservoir and the eluate tubing line;
pumping a sample of the rubidium radioactive eluate into the eluate reservoir in the shielded well on-board the cart;
measuring a radioactivity of the sample of the rubidium radioactive eluate flowing through the eluate tubing line with a radioactivity detector on-board the cart while the sample of the rubidium radioactive eluate is flowing through the eluate tubing line;
measuring a calibration radioactivity of the sample pumped 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;
comparing the radioactivity of the sample of the rubidium radioactive eluate flowing through the eluate tubing line measured by the radioactivity detector on-board the cart while the sample of the rubidium radioactive eluate is flowing through the eluate tubing line with the calibration radioactivity of the sample pumped into the eluate reservoir in the shielded well on-board the cart; and
determining a strontium breakthrough test result on the sample pumped 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 computer of the infusion system is further configured to not allow a patient infusion if the strontium breakthrough test result is greater than or equal to an allowed limit.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
placing the eluate tubing line in fluid communication with a patient, wherein the computer is further configured to control the fluid communication between the eluate tubing line and the patient;
pumping a dose of the rubidium radioactive eluate to the patient; and
flushing 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, wherein the computer is further configured to control fluid communication via the by-pass line.

### Claim 3 (depends on 2)

The method of claim 2, further comprising:
logging into the computer by entering a user login credential on the touch screen display,
transferring a patient infusion record via a USB port, and
printing a document concerning the patient infusion or a quality control test result via a printer.

### Claim 4 (depends on 2)

The method of claim 2, further comprising:
initiating a purging process through the touch screen display to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.

### Claim 5 (depends on 2)

The method of claim 2, wherein the computer of the infusion system is further configured to present on the touch screen display a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart.

### Claim 6 (depends on 2)

The method of claim 2, wherein the computer of the infusion system is further configured to present on the touch screen display a screen for starting the patient infusion by touching a button on the touch screen display.

### Claim 7 (depends on 2)

The method of claim 2, wherein the computer of the infusion system is further configured to present on the touch screen display a screen indicating that the patient infusion is in process, wherein the screen indicating that the patient infusion is in process displays a stop button to abort the patient infusion.

### Claim 8 (depends on 2)

The method of claim 2, wherein the computer of the infusion system is further configured to:
present on the touch screen display a screen for starting the patient infusion by touching a button on the touch screen display;
present on the touch screen display a screen reminding a user to insert the eluate reservoir in the shielded well on-board the cart;
present on the touch screen display a screen indicating that the patient infusion is in process, wherein the screen indicating that the patient infusion is in process displays a stop button to abort the patient infusion; and
present on the touch screen display the strontium breakthrough test result.

### Claim 9 (depends on 8)

The method of claim 8, further comprising:
logging into the computer by entering a user login credential on the touch screen display,
entering a patient ID on the touch screen display,
entering a patient dose on the touch screen display, and
entering a flow rate on the touch screen display.

### Claim 10 (depends on 9)

The method of claim 9, wherein the computer of the infusion system is further configured to:
track a volume of saline remaining in the saline reservoir,
provide an alert via the touch screen display when the volume of saline remaining in the saline reservoir is below a predetermined volume threshold,
and
present on the touch screen display a screen reminding the user to empty the waste bottle.

### Claim 11 (depends on 10)

The method of claim 10, further comprising:
initiating a generator column wash through the touch screen display, 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
initiating a purging process through the touch screen display to purge a patient tubing line of air, wherein the patient tubing line is in fluid communication with the eluate tubing line.

### Claim 12 (depends on 11)

The method of claim 11, wherein the saline tubing line and the eluate tubing line are routed through two tubing passageways formed in a perimeter surface of the first opening, wherein each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when a first door is closed over the first opening.

### Claim 13 (depends on 12)

The method of claim 12, wherein the infusion system further comprises:
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.

### Claim 14 (depends on 13)

The method of claim 13, wherein the computer of the infusion system is further configured to:
project a first light signal from a light projector mounted on the top end of the 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.

### Claim 15 (depends on 14)

The method of claim 14, 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.

### Claim 16 (depends on 13)

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

### Claim 17 (depends on 16)

The method of claim 16, 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.

### Claim 18 (depends on 1)

The method of claim 1, wherein the computer of the infusion system is further configured to present on the touch screen display the strontium breakthrough test result.

### Claim 19 (depends on 1)

The method 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.

### Claim 20 (depends on 1)

The method of claim 1, wherein the saline tubing line and the eluate tubing line are routed through two tubing passageways formed in a perimeter surface of the first opening, wherein each of the two tubing passageways has a depth configured to prevent pinching or crushing of a corresponding tubing line routed therethrough when a first door is closed over the first opening.

### Claim 21 (depends on 1)

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

### Claim 22 (depends on 1)

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

### Claim 23 (depends on 1)

The method 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
present on the touch screen display a screen reminding a user to empty the waste bottle.

### Claim 24 (depends on 1)

The method of claim 1, wherein the computer of the infusion system is further configured to:
project a first light signal from a light projector mounted on the top end of the 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.

### Claim 25 (depends on 1)

The method 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.

### Claim 26 (depends on 1)

The method of claim 1, further comprising:
initiating a generator column wash through the touch screen display, 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.

### Claim 27 (depends on 1)

The method of claim 1, wherein the computer of the infusion system is further configured to track time passed from completion of pumping the sample of the rubidium radioactive eluate into the eluate reservoir to determining the strontium breakthrough test result.

### Claim 28 (depends on 1)

The method of claim 1, further comprising:
entering a patient ID on the touch screen display,
entering a patient dose on the touch screen display, and
entering a flow rate on the touch screen display.

### Claim 29 (depends on 1)

The method of claim 1, wherein the saline reservoir is located outside of the interior space of the cabinet structure.

### Claim 30 (depends on 1)

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 platform of the cabinet structure.