SYSTEM, METHOD AND DEVICE FOR DELIVERY OF A THERAPEUTIC OR DIAGNOSTIC AGENT

Claims

1. A fluid injector delivery system comprising: at least one fluid container, which is a first fluid container configured to receive a radiopharmaceutical; a radiation filter in fluid communication with at least one fluid container and configured to retain radioactive particles from a radiopharmaceutical passing through the radiation filter; at least one sensor configured to detect radioactivity in at least one of the elements of a group comprising a first fluid container, a radiation filter, and a fluid passage element in fluid communication with the radiation filter; and a controller in operative communication with at least one sensor, wherein the controller is programmed or configured to: receiving radioactivity measurement results from at least one sensor; and establishing, based on the results of the radioactivity measurement, that the amount of radioactive particles in at least one of the elements of the group comprising the first fluid container, the radiation filter and the fluid passage element corresponds to a predetermined threshold.

2. The fluid injector delivery system of claim 1, wherein the predetermined threshold includes at least one value from the list: predetermined dose of radiopharmaceutical; predetermined safe dose of radiopharmaceutical; predetermined retention volume; a predetermined rate of change of radioactivity relative to the volume of fluid passing through the filter; and a predetermined rate of change of radioactivity over time.

3. The fluid injector delivery system of claim 1, wherein the controller is further programmed or configured to determine, based on the radioactivity measurement result and at least one injection parameter, the total amount of radiopharmaceutical injected from the first fluid container.

4. The fluid injector delivery system of claim 3, wherein at least one injection parameter comprises at least one value from the list: rate of administration of radiopharmaceutical; volume of administered radiopharmaceutical; duration of administration of the radiopharmaceutical; half-life of a radiopharmaceutical; decay chain of a radiopharmaceutical; age of the radiopharmaceutical; total volume of radiopharmaceutical; radiopharmaceutical concentration; initial radioactivity of the radiopharmaceutical.

5. The fluid injector delivery system of claim 3, wherein the controller is further programmed or configured to compare the total amount of radiopharmaceutical administered with a predetermined prescribed dose.

6. The fluid injector delivery system of claim 3, wherein the controller is further programmed or configured to adjust the rate of administration of the radiopharmaceutical based on the total amount of radiopharmaceutical administered.

7. The fluid injector delivery system of claim 3, wherein the controller is further programmed or configured to stop the injection procedure in response to the total amount of radiopharmaceutical administered satisfying a predetermined threshold.

8. The fluid injector delivery system of claim 1, wherein the controller is further programmed or configured to determine, based on the radioactivity measurement result obtained from the at least one sensor, a residual level of radioactive particles in the radiation filter or in the fluid passage set.

9. The fluid injector delivery system of claim 1, wherein the controller is further programmed or configured to determine, based on the radioactivity measurement result obtained from the at least one sensor, that the radiopharmaceutical is in a chelate.

10. The fluid injector delivery system of claim 1, wherein the at least one sensor includes: a first sensor coupled to a fluid flow path located upstream of the radiation filter; and a second sensor connected to a fluid flow path located downstream of the radiation filter, in which the controller is programmed or configured to determine the amount of radioactive particles retained by the radiation filter by comparing the radioactivity measurement result from the first sensor and the radioactivity measurement result from the second sensor.

11. The fluid injector delivery system of claim 1, wherein the fluid flow set includes an intermediate vessel in fluid communication with at least one fluid container and located downstream of the at least one fluid container, wherein at least one of the sensors is coupled to the intermediate vessel for detecting radiation in the intermediate vessel, and wherein the controller is configured to prohibit the delivery of the radiopharmaceutical from the intermediate vessel to the patient based on a deviation in the amount of radioactive particles in the intermediate vessel from a predetermined threshold.

12. The fluid injector delivery system of claim 1, wherein at least one fluid container is an additional fluid container configured to receive a flushing agent.

13. The fluid injector delivery system of claim 1, wherein at least one fluid container is an additional fluid container configured to administer another pharmaceutical preparation.

14. The fluid injector delivery system of claim 13, wherein the other pharmaceutical preparation is a protective preparation.

15. The fluid injector delivery system of claim 1, wherein the first fluid container comprises a radiopharmaceutical generator.

16. The fluid injector delivery system of claim 1, wherein the first fluid container comprises: a housing having a chamber formed therein; a vessel located within the chamber, the vessel having a distal end opposite the proximal end with an internal space formed therebetween and configured to receive a radiopharmaceutical, the proximal end having an inlet for accessing the internal space; a valve connected to the housing, wherein the valve is movable relative to the housing between a closed position and an open position, wherein in the closed position the valve closes an opening in the housing for enclosing the chamber of the housing, and wherein in the open position the valve opens an opening in the housing for access to the inlet of the vessel; and a holder inside the chamber of the housing and in contact with the vessel for fixing the vessel relative to the housing so that the inlet of the vessel is located in the opening of the housing, in which the valve of the first fluid container is configured to move between a closed and an open position in response to actuation of the access mechanism of the supply system of the fluid injector.

17. A filtration system for a radiopharmaceutical fluid injector system, the filtration system comprising: a radiation filter in fluid communication with at least one fluid reservoir of the radiopharmaceutical fluid injector system, the radiation filter being configured to retain radioactive particles from a radiopharmaceutical received from the radiopharmaceutical fluid injector system; at least one sensor configured to detect radioactivity in at least one of the elements of a group consisting of a fluid container, a radiation filter, and a fluid passage assembly in fluid communication with the radiation filter; and a controller in operative communication with at least one sensor, wherein the controller is programmed or configured to: receiving radioactivity measurement results from at least one sensor; and determining, based on the result of measuring radioactivity, compliance with a predetermined threshold of the amount of radioactive particles in at least one of the elements of a group consisting of a fluid container, a radiation filter and a fluid passage set.

18. A fluid injector system comprising: at least one fluid container, which is a first fluid container configured to receive a radiopharmaceutical; a fluid passage set in communication with at least one fluid container, wherein the fluid passage set comprises at least one fluid passage element, including a catheter configured to be inserted into a venous access site of a patient; a patient sensor configured to detect radioactivity in a patient in relation to a venous access site; and a controller in operative communication with the patient sensor and the fluid flow set sensor, wherein the controller is programmed or configured to: obtaining radioactivity measurement results from the patient's sensor; and establishing, based on measurements of radioactivity by the patient's sensor, the presence or absence of retention of a radiopharmaceutical in the patient's body.

19. The fluid injector system of claim 18, including a fluid passage set sensor configured to detect radioactivity in the fluid passage set upstream of the venous access site.

20. The fluid injector system of claim 18, wherein the controller is programmed or configured to alter or stop the injection procedure in response to detecting the presence of a hold.

21. The fluid injector system of claim 19, wherein the controller is further programmed or configured to establish, based on measurements of radioactivity by the patient sensor and the fluid flow set sensor, retention of the radiopharmaceutical at the venous access site.

22. The fluid injector system of claim 19, wherein the at least one fluid container is an additional second fluid container configured to administer a flushing agent, and wherein the controller is programmed or configured to increase the administration of the flushing agent in response to establishing retention of the radiopharmaceutical at the venous access site.

23. The fluid injector system of claim 19, wherein the controller is further programmed or configured to determine, based on a comparison of radioactivity measurements from the patient sensor and the fluid passage set sensor, a leak in the fluid passage set.

24. The fluid injector system of claim 19, wherein the controller is further programmed or configured to detect, based on a comparison of the radioactivity measurements from the patient sensor and the fluid passage set sensor, a lock in the fluid passage set.

25. The fluid injector system of claim 18, further comprising a reference sensor configured to detect radioactivity in a patient at a distance from the venous access site, wherein the controller is programmed or configured to: obtaining radioactivity measurement results from a reference sensor; and fixation, based on a comparison of the results of radioactivity measurements by the patient's sensor and the reference sensor, of the presence or absence of retention of the radiopharmaceutical in the patient's body.

26. A retention detection system for a radiopharmaceutical fluid injector system, the retention detection system comprising: a patient sensor configured to detect radioactivity in a patient near a venous access site of the patient; a fluid passage set sensor configured to detect radioactivity in a fluid passage set of a fluid injector system upstream of a venous access site; and a controller in operative communication with the patient sensor and the fluid flow set sensor, wherein the controller is programmed or configured to: obtaining radioactivity measurement results from the patient sensor and the fluid flow set sensor; and fixation, based on the results of radioactivity measurements obtained from the patient sensor and the sensor of the fluid passage set, of the presence or absence of retention of the radiopharmaceutical in the patient's body.