US 12,144,876 B2
Security mechanisms for radiopharmaceutical elution system and elution process
Riccardo Santopietro, Pierrefonds (CA); Robert William Riddoch, Pierrefonds (CA); Paul Donnelly, L'lle Bizard (CA); Etienne Lefort, Kirkland (CA); and Cristian-Leonardo Juverdianu, Dorval (CA)
Assigned to Jubilant Draximage Inc., (CA)
Filed by Jubilant Draximage Inc., Kirkland (CA)
Filed on Feb. 12, 2024, as Appl. No. 18/439,175.
Application 18/439,175 is a continuation of application No. 16/832,412, filed on Mar. 27, 2020, granted, now 11,904,028.
Claims priority of provisional application 62/826,730, filed on Mar. 29, 2019.
Prior Publication US 2024/0181097 A1, Jun. 6, 2024
Int. Cl. A61K 51/12 (2006.01); G21F 5/015 (2006.01); G21G 4/08 (2006.01)
CPC A61K 51/1217 (2013.01) [G21F 5/015 (2013.01); G21G 4/08 (2013.01)] 20 Claims
OG exemplary drawing
 
1. An 82Sr/82Rb elution system comprising a radioisotope generator containing a parent radioisotope that decays into a daughter radioisotope, a patient line for infusing a patient with a daughter radioisotope eluate generated by the generator, a pump for pumping an eluant from an eluant reservoir into the generator, a controller, and a user interface, a dose calibrator, wherein the system has a mechanism for identifying whether the eluant is a saline solution or not, said mechanism comprises:
a liquid parameter detector, wherein the liquid parameter detector is adapted to detect in the eluant at least one of the following parameters:
i. pH,
ii. quantity of divalent ions or trivalent ions,
iii. piezoelectricity,
iv. light absorbance detected by atomic absorption spectroscopy, based on absorption of light of free metallic ions,
v. photoelectricity detected by flame photometry, atomic emission detected by atomic emission spectroscopy (AES),
vi. optical emission detected by inductively coupled plasma atomic emission spectroscopy (ICP-AES) also referred to as inductively coupled plasma optical emission spectrometry (ICP-OES),
vii. atomic mass detected by inductively coupled plasma mass spectrometry (ICP-MS),
viii. EDTA complexing ability,
ix. fluorescence detected by X-ray fluorescence (XRF), and
x. element content detected by a particle-induced X-Ray Emission (PIXE),
wherein the dose calibrator detects the parent radioisotope content in a sample of eluate and a controller for controlling the pump,
wherein: the controller is configured for automatically performing a daily quality control test at a pre-determined time of the day that was configured by a user, and
the daily quality control test comprises the detection of a parent radioisotope content in said sample of the radioisotope eluate.
 
18. An 82Sr/82Rb elution system comprising a radioisotope generator containing a parent radioisotope that decays into a daughter radioisotope, a patient line for infusing a patient with a daughter radioisotope eluate generated by the generator, a pump for pumping an eluant from an eluant reservoir into the generator, a controller, a user interface, and a dose calibrator, wherein the system has a mechanism for identifying whether the eluant is a saline solution or not, said mechanism comprises:
a liquid parameter detector, wherein the liquid parameter detector is adapted to detect in the eluant at least one of the following parameters:
i. pH,
ii. quantity of divalent ions or trivalent ions,
iii. piezoelectricity,
iv. light absorbance detected by atomic absorption spectroscopy, based on absorption of light of free metallic ions,
v. photoelectricity detected by flame photometry, atomic emission detected by atomic emission spectroscopy (AES),
vi. optical emission detected by inductively coupled plasma atomic emission spectroscopy (ICP-AES) also referred to as inductively coupled plasma optical emission spectrometry (ICP-OES),
vii. atomic mass detected by inductively coupled plasma mass spectrometry (ICP-MS),
viii. EDTA complexing ability,
ix. fluorescence detected by X-ray fluorescence (XRF), and
x. element content detected by a particle-induced X-Ray Emission (PIXE),
wherein the dose calibrator detects the parent radioisotope content in a sample of eluate and a controller for controlling the pump,
wherein: the controller is configured for automatically performing a daily quality control test at a pre-determined time of the day that was configured by a user, and
the daily quality control test comprises the detection of a parent radioisotope content in said sample of the radioisotope eluate, and
wherein said pre-determined time of the day is outside the user working hours.
 
19. An 82Sr/82Rb elution system comprising a radioisotope generator containing a parent radioisotope that decays into a daughter radioisotope, a patient line for infusing a patient with a daughter radioisotope eluate generated by the generator, a pump for pumping an eluant from an eluant reservoir into the generator, a controller, a user interface, and a dose calibrator, wherein the system has a mechanism for identifying whether the eluant is a saline solution or not, said mechanism comprises:
a liquid parameter detector, wherein the liquid parameter detector is adapted to detect in the eluant at least one of the following parameters:
i. pH,
ii. quantity of divalent ions or trivalent ions,
iii. piezoelectricity,
iv. light absorbance detected by atomic absorption spectroscopy, based on absorption of light of free metallic ions,
v. photoelectricity detected by flame photometry, atomic emission detected by atomic emission spectroscopy (AES),
vi. optical emission detected by inductively coupled plasma atomic emission spectroscopy (ICP-AES) also referred to as inductively coupled plasma optical emission spectrometry (ICP-OES),
vii. atomic mass detected by inductively coupled plasma mass spectrometry (ICP-MS),
viii. EDTA complexing ability,
ix. fluorescence detected by X-ray fluorescence (XRF), and
x. element content detected by a particle-induced X-Ray Emission (PIXE),
wherein the dose calibrator detects the parent radioisotope content in a sample of eluate and a controller for controlling the pump,
wherein: the controller is configured for automatically performing a daily quality control test at a pre-determined time of the day that was configured by a user, and
the daily quality control test comprises the detection of a parent radioisotope content in said sample of the radioisotope eluate, and
wherein said pre-determined time of the day is outside the user working hours, and
wherein the system is stopped after a quality control test, or when the controller stops the pump upon detecting an error in the system.