Systems, methods and apparatus for infusion of radiopharmaceuticals

• US 20080242915A1
• Filed: 03/02/2004
• Published: 10/02/2008
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: General Electric Company
• Original Assignee: General Electric Company
• Inventors: Dhawale, Paritosh Jayant, Brussermann, Michael, Jackson, Mark Alan, Lara, Hernan Rodrigo, Ketzscher, Ulrich
• Granted Patent: US 9,627,097 B2
• Time in Patent Office: Days
• US Class Current: 600/4
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 6/548 Remote control of the apparatus or devices
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1785 comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: G01T 1/00 Measuring X-radiation, gamma radiation, corpuscular radiation, or cosmic radiation G01T3/00, G01T5/00 take precedence
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 30/40 for processing medical images, e.g. editing
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G21F 5/018 Syringe shields or holders syringe shielding for applying radioactive material to the body A61M5/1785
• CPC Class Codes: G21G 4/08 specially adapted for medical application radiation therapy using radioactive sources A61N5/10
• CPC Class Codes: G21H 5/02 as tracers

Abstract

Systems, apparatus and methods are provided through which an injector system automates a process of injecting an individual dose from a multiple dose of a radiotracer material. In some embodiments, the injector system includes a first dose calibrator system that receives a multidose vial of a radiotracer, a second dose calibrator system, an injection pump and an intravenous needle. In some embodiments, the first dose calibrator system and the multidose vial have an integrated shape. In some embodiments, the first dose calibrator system includes a pneumatic arm that receives the multidose vial.

Claims

1. An apparatus comprising:

a reservoir operable to store multiple doses of a radiotracer;

an extracting apparatus operably coupled to the reservoir to extract an individual dose of the radiotracer from the reservoir;

a radioactivity-shielded line, to transfer the individual dose of the radiotracer, having a first end and a second end, the first end operably coupled to the extracting apparatus, the radioactivity-shielded line further comprises a line that shields radioactivity; and

an intravenous injection apparatus to inject the individual dose of the radiotracer into a living subject, operably coupled to the second end of the radioactivity-shielded line.

2. The apparatus of claim 1, wherein the intravenous injection apparatus is operably coupled to the extracting apparatus through intravenous tubing.

3. The apparatus of claim 1, wherein the radiotracer further comprises nitrogen-13 ammonia.

4. The apparatus of claim 1, wherein the radiotracer further comprises fluorodeoxyglucose.

5. An apparatus comprising:

an extracting apparatus to extract an individual dose of a radiopharmaceutical from a multiple dose of the radiopharmaceutical, wherein the radiopharmaceutical is selected from the group consisting of nitrogen-13 ammonia, fluorodeoxyglucose, carbon-11 and oxygen-15;

a lead-shielded line, to transfer the individual dose of the radiopharmaceutical, having a first end and a second end, the first end operably coupled to the extracting apparatus; and

an intravenous injection apparatus operably coupled to the second end of the radioactivity-shielded line, to inject the individual dose of the radiopharmaceutical into a living subject.

6. The apparatus of claim 5, wherein the intravenous injection apparatus is operably coupled to the extracting apparatus through intravenous tubing.

7. A dose calibrator system comprising:

a holding apparatus mounted inside an injector, to hold inside the injector apparatus, a reservoir operable to store multiple doses of a radiotracer; and

an extracting apparatus mounted inside the injector, to extract an individual dose of a radiotracer from a reservoir.

8. The dose calibrator system of claim 7, wherein the dose calibrator system is further operably coupled to an intravenous injection apparatus.

9. The dose calibrator system of claim 7, wherein the dose calibrator system is further operably coupled through intravenous tubing to a solenoid driven 3-way stopcock, an intravenous bag of saline, a peristaltic pump, a second dose calibrator system, a second solenoid driven 3-way stopcock, an intravenous bag containing a stress agent, an infusion pump, and an intravenous injection apparatus.

10. The dose calibrator system of claim 7, wherein the dose calibrator system further comprises a pneumatic cylinder to raise and lower the reservoir into and out of the dispensing station.

11. The dose calibrator system of claim 7, wherein the dose calibrator system further comprises an outer lead shield.

12. The dose calibrator system of claim 7, wherein the reservoir further comprises an outer lead shield.

13. The dose calibrator system of claim 7, wherein the radiotracer further comprises nitrogen-13 ammonia.

14. The dose calibrator system of claim 7, wherein the radiotracer further comprises fluorodeoxyglucose.

15. A radiopharmaceutical injector comprising:

an extracting apparatus to extract an individual dose of a radiopharmaceutical from a reservoir operable to store multiple doses of the radiopharmaceutical;

a dose calibrator system operably coupled to the extracting apparatus, to receive the individual dose of the radiopharmaceutical;

an infusion pump operably coupled to the dose calibrator system, to pump the individual dose of the radiopharmaceutical from the dose calibrator system; and

an intravenous needle operably coupled to the infusion pump to inject the individual dose of the radiopharmaceutical into a living subject.

16. The radiopharmaceutical injector of claim 15, wherein the extracting apparatus further comprises a second dose calibrator system.

17. The radiopharmaceutical injector of claim 15, wherein each of the dose calibrator systems further comprise an ion chamber.

18. The radiopharmaceutical injector of claim 15, wherein a 3-way stopcock is operably coupled between the extracting apparatus and the dose calibrator system, and a saline bag is operably coupled to an input of the 3-way stopcock.

19. The radiopharmaceutical injector of claim 18, wherein a peristaltic pump is operably coupled between the 3-way stopcock and the dose calibrator system.

20. The radiopharmaceutical injector of claim 15, wherein the dose calibrator system further comprises an ion chamber.

21. The radiopharmaceutical injector of claim 15, wherein a 3-way stopcock is operably coupled between the dose calibrator system and the infusion pump, and a saline bag is operably coupled to an input of the 3-way stopcock.

22. The radiopharmaceutical injector of claim 21, wherein a waste reservoir is operably coupled between the 3-way stopcock and the infusion pump.

23. The radiopharmaceutical injector of claim 15, wherein the radiotracer further comprises fluorodeoxyglucose.

24. The radiopharmaceutical injector of claim 15, wherein the radiotracer further comprises nitrogen-13 ammonia.

25. The radiopharmaceutical injector of claim 15, wherein the coupling further comprises intravenous tubing.

26. An injector system comprising:

apparatus operable to extract an individual dose of a radiopharmaceutical from a multiple dose of the radiopharmaceutical;

apparatus operable to calibrate a dose, operably coupled to the apparatus operable to extract, to receive the individual dose of the radiopharmaceutical;

apparatus operable to infuse pumping, operably coupled to the apparatus to calibrate a dose, to pump the individual dose of the radiopharmaceutical from the apparatus operable to calibrator an individual dose; and

apparatus operable to inject, operably coupled to the apparatus operable to infuse, and operable to pump to inject the individual dose of the radiopharmaceutical into a patient.

27. The injector system of claim 26, wherein the apparatus operable to calibrate further comprises:

an intravenous needle operably coupled to the apparatus operable to infuse to inject the individual dose of the radiopharmaceutical into a living subject.

28. The injector system of claim 27, wherein the apparatus operable to calibrate a dose further comprises an ion chamber.

29. The injector system of claim 26, wherein the radiopharmaceutical is fluorodeoxyglucose.

30. The injector system of claim 26, wherein the radiopharmaceutical is nitrogen-13 ammonia.

31. The injector system of claim 26, wherein the coupling further comprises intravenous tubing.

32. A dose calibrator system comprising:

a carriage arm to hold a multidose vial having a shape that is integrated with the carriage arm and a shipping container for the multidose vial; and

an extracting apparatus for extracting contents of the multidose vial.

33. The dose calibrator system of claim 32, wherein the dose calibrator system further comprises an ion chamber.

34. A system comprising:

a cyclotron room to produce a radiotracer in a building;

a dose calibrator system in the building to receive the radiotracer through tubing from the cyclotron room and to extract an individual dose from the radiotracer;

an infusion device to receive the individual dose of the radiotracer through tubing from the dose calibrator system; and

an intravenous injection apparatus to receive the individual dose of the radiotracer from the infusion device and to inject the radiotracer into a living subject.

35. The system of claim 34, wherein the cyclotron room further comprises:

a cyclotron target to produce the radiotracer;

a pump to receive the radiotracer through tubing; and

a holding reservoir to receive the radiotracer from the pump through tubing, to circulate the radiotracer within the holding reservoir, and to return the radiotracer to the pump.

36. The system of claim 35, wherein the cyclotron room further comprises a rinse solution reservoir, the pump to receive rinse solution from the rinse solution reservoir through tubing.

37. The system of claim 34, wherein the cyclotron room further comprises a waste reservoir, the pump to return unneeded portions of the radiotracer to the waste reservoir through tubing.

38. The system of claim 34, wherein the system further comprises a filter operably coupled between the cyclotron room and the dose calibrator system.

39. The system of claim 34, wherein the dose calibrator system further comprises an ion chamber.

40. The system of claim 34, wherein the infusion device further comprise a syringe pump.

41. The system of claim 34, wherein the system further comprises a waste reservoir, the infusion device to return unneeded portions of the radiotracer to the waste reservoir through tubing.

42. The system of claim 34, wherein the system further comprises a pharmaceutical reservoir, the infusion device to receive a pharmaceutical from the pharmaceutical reservoir through tubing.

43. The system of claim 42, wherein the pharmaceutical further comprises a pharmaceutical stress agent.

44. The system of claim 34, wherein the system further comprises a sterile water reservoir, the pump to receive sterile water from the sterile water reservoir through tubing.

45. The system of claim 34, wherein the radiotracer further comprises nitrogen-13 ammonia.

46. The system of claim 34, wherein the system further comprises:

a quality control unit to sample the individual dose of radiotracer from the infusion device through tubing.

47. The system of claim 34, wherein the cyclotron room further comprises:

a cyclotron target to produce the radiotracer;

a pump operably coupled to the cyclotron target; and

a quality control unit to sample the radiotracer from the cyclotron target through tubing, producing a radiopharmaceutical.

48. The system of claim 34, wherein the system further comprises:

an ion chamber operably coupled between the dose calibrator system and the infusion device, wherein the ion chamber is operable to measure radioactivity of each individual dose of the radiotracer immediately prior to injection.

49. A system comprising:

a cyclotron room to produce a nitrogen-13 ammonia radiotracer in a building;

a dose calibrator system in the building to receive the radiotracer through tubing from the cyclotron room and to extract an individual dose from the radiotracer;

an infusion device to receive the individual dose of the radiotracer through tubing from the dose calibrator system;

a pharmaceutical reservoir to transport a pharmaceutical to the infusion device through tubing;

a quality control unit to sample the individual dose of the radiotracer from the infusion device through tubing to produce a radiopharmaceutical;

an intravenous injection apparatus to receive the quality controlled individual dose of the radiopharmaceutical and the pharmaceutical from the infusion device and to inject the radiopharmaceutical and the pharmaceutical into a patient.

50. The system of claim 49, wherein the cyclotron room further comprises:

a cyclotron target to produce the radiotracer;

a pump to receive the radiotracer through tubing;

a holding reservoir to receive the radiotracer from the pump through tubing, to circulate the radiotracer within the holding reservoir, and to return the radiotracer to the pump.

51. The system of claim 49, wherein the cyclotron room further comprises a rinse solution reservoir, the pump to receive rinse solution from the rinse solution reservoir through tubing.

52. The system of claim 49, wherein the cyclotron room further comprises a waste reservoir, the pump to return unneeded portions of the radiotracer to the waste reservoir through tubing.

53. The system of claim 49, wherein the system further comprises a filter operably coupled between the cyclotron room and the dose calibrator system.

54. The system of claim 49, wherein the dose calibrator system further comprises an ion chamber.

55. The system of claim 49, wherein the infusion device further comprises a syringe pump.

56. The system of claim 49, wherein the system further comprises a waste reservoir, the infusion device to return unneeded portions of the radiotracer to the waste reservoir through tubing.

57. The system of claim 49, wherein the system further comprises a sterile water reservoir, the pump to receive sterile water from the sterile water reservoir through tubing.

58. The system of claim 49, wherein the system further comprises:

an ion chamber operably coupled between the dose calibrator system and the infusion device, wherein the ion chamber is operable to measure radioactivity of each individual dose of the radiotracer immediately prior to injection.

59. A method of preparing an injector system for use by a number of patients, the method comprising:

activating a computer system;

delivering a multidose vial of a radiopharmaceutical to the injector system that is controlled by the computer system; and

raising the multidose vial into a dose calibrator system of the injector system.

60. The method of claim 59, wherein the activating is performed before the delivering.

61. The method of claim 59, wherein the radiopharmaceutical further comprises nitrogen-13 ammonia.

62. The method of claim 59, wherein the radiopharmaceutical further comprises fluorodeoxyglucose.

63. A method of preparing an injector system for an individual patient, the method comprising:

installing a patient vial into a dose calibrator system of the injector system, the patient vial being sterile and pyrogens-free;

connecting an output needle to a line from a peristaltic pump of the injector system;

inserting the output needle into the bottom of the patient vial;

placing the patient vial into the dose calibrator system;

installing a stopcock into the injector system;

installing an intravenous line through the stopcock;

installing an intravenous needle into the injector system; and

attaching a saline bag to the stopcock.

64. The method of claim 63, wherein the installing a stopcock into the injector system, installing an intravenous line through the stopcock, installing an intravenous needle into the injector system and attaching a saline bag to the stopcock is performed after the placing the patient vial into the dose calibrator system.

65. A method of administering a radioactive injection to a patient using an injector system, the method comprising:

extracting an individual dose of a radiopharmaceutical from a multi dose vial;

pumping the pharmaceutical through a first 3-way stopcock of the injector system into a patient vial that is located in a patient dose calibrator system;

verifying that the amount of radioactivity in the patient vial is the same amount of radioactivity that has been vacated from the multi dose vial;

adding saline from a saline bag and a saline line into the patient vial through a second 3 way stopcock; and

injecting the contents of the patient vial at a prescribed rate into the patient.

66. The method of claim 65, wherein the method further comprises:

selecting an input on the second 3 way stopcock to allow flow from the saline to purge a patient line of radioactive substances;

removing the patient line, the second stopcock and the saline line;

placing the patient line, the saline line and the second stopcock into the patient dose calibrator system; and

measuring residual radioactivity in the patient dose calibrator system.