Radiopharmaceutical dispensing, administration, and imaging

• US 8,620,679 B2
• Filed: 10/31/2007
• Issued: 12/31/2013
• Est. Priority Date: 11/09/2004
• Status: Active Grant

• Current Assignee: Spectrum Dynamics Medical Ltd
• Original Assignee: Biosensors International Group, Ltd.
• Inventors: Ben-Haim, Shlomo, Melman, Haim, Zilberstein, Yoel, Nagler, Michael, Dickman, Dalia, Omer, Einav, Rousso, Benny, Bronshtine, Zohr
• Primary Examiner(s): NGUYEN, HIEP VAN
• Application Number:
  US11/932,987
• Publication Number:
  US 20080195249A1
• Time in Patent Office: 2,253 Days
• Field of Search: 705/2
• US Class Current: 705/2
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/1785 comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Apparatus is provided for use with at least one labeled radiopharmaceutical agent, the apparatus including a container (22) containing the at least one labeled radiopharmaceutical agent, and a portable computer-communcatable data carrier (120, 24) associated with the container (22), the data (120, 24) containing imaging protocol information for use with the at least one labeled radiopharmaceutical agent. Other embodiments are also described.

Claims

1. Apparatus for use with a container and a computer-communicatable container data carrier physically coupled to the container, the apparatus comprising:

an imaging system which comprises a camera and an imaging control unit; and

an automated radiopharmaceutical dispensing system, which comprises;

a robot, configured to manipulate the container;

a communication element; and

a dispensing system control unit, configured to;

receive imaging protocol information indicative of steps of an imaging procedure, for use with at least one labeled radiopharmaceutical agent,

receive patient information regarding a patient,

drive the robot to automatically dispense a dose of the at least one labeled radiopharmaceutical agent to the container, and

drive the communication element to transmit to the container data carrier (a) the imaging protocol information indicative of the steps of the imaging procedure, for use by the imaging control unit for driving the camera to perform the steps of the imaging procedure, and (b) at least a portion of the patient information,

wherein the imaging system is configured to receive the imaging protocol information from the container data carrier, and

wherein the imaging control unit is configured to drive the camera to perform the steps of the imaging procedure responsively to the imaging protocol information received from the container data carrier.

2. The apparatus to claim 1, wherein the imaging control unit is configured to receive the imaging protocol information regarding a plurality of labeled radiopharmaceutical agents, and drive the robot to automatically dispense respective doses of the labeled radiopharmaceutical agents to the container.

3. The apparatus according to claim 1,

wherein the imaging protocol information indicative of the steps of the imaging procedure comprises:

an identifier of an imaging protocol assigned to the patient for performance using the dose,

wherein the dispensing system control unit is configured to drive the communication element to transmit the imaging protocol identifier to the container data carrier, and

wherein the imaging control unit is configured to drive the camera to perform the steps of the imaging procedure responsively to the identifier of the imaging protocol received from the container data carrier.

4. The apparatus according to claim 1, wherein the dispensing system control unit is configured to drive the communication element to transmit to the container data carrier at least one of:

a time of dispensing of the at least one labeled radiopharmaceutical agent to the container, and information regarding a radioactivity of the dose at the time of dispensing.

5. The apparatus according to claim 1, comprising:

a mother vial that contains the at least one labeled radiopharmaceutical agent prior to dispensing thereof; and

a computer-communicatable mother vial data carrier associated with the mother vial, which mother vial data carrier contains the imaging protocol, information,

wherein the imaging control unit is configured to receive the imaging protocol information from the mother vial data carrier.

6. The apparatus according to claim 5, wherein the mother vial data carrier is physically coupled to the mother vial.

7. The apparatus according to claim 1, wherein the imaging protocol information comprises SPECT imaging protocol information.

8. The apparatus according to claim 1, wherein the dispensing system control unit is configured to further receive the authenticatable information regarding a commercial license for use of the imaging protocol information with the at least one labeled radiopharmaceutical agent.

9. The apparatus according to claim 8, wherein the information regarding the commercial license comprises information regarding the commercial license for use of a SPECT imaging protocol with the at least one labeled radiopharmaceutical agent.

10. The apparatus according to claim 8, wherein the dispensing system control unit is configured to authenticate the authenticatable license information, and to drive the robot to automatically dispense the dose only upon authentication.

11. The apparatus according to claim 1, wherein the system further comprises the container and the computer-communicatable container data carrier physically coupled to the container.

12. The apparatus according to claim 11, wherein the computer-communicatable container data carrier comprises circuitry.

13. The apparatus according to claim 11, wherein the computer-communicatable container data carrier comprises an RFID tag.

14. The apparatus according to claim 11, wherein the computer-communicatable container data carrier comprises a computer-communicable element selected from the group consisting of:

a smart card and a disk-on-key.

15. The apparatus according to claim 11, wherein the container comprises shielding.

16. The apparatus according to claim 1,

wherein the imaging protocol information indicative of the steps of the imaging procedure comprises instructions for performing the imaging procedure using the at least one labeled radiopharmaceutical agent, and

wherein the imaging control unit is configured to drive the camera to perform the steps of the imaging procedure by executing the instructions of the imaging protocol information.

17. Apparatus for use with a container and a computer-communicatable container data carrier physically coupled to the container, the apparatus comprising;

an imaging system, which comprises a camera and an imaging control unit; and

an automated radiopharmaceutical dispensing system, which comprises;

a robot, configured to manipulate the container;

a communication element;

a dispensing system control unit, configured to;

receive SPECT imaging protocol information that comprises at least one pharmacologic kinetic parameter of at least one labeled radiopharmaceutical agent, for use with the at least one labeled radiopharmaceutical agent,

receive patient information regarding a patient,

drive the robot to automatically dispense a dose of the at least one labeled radiopharmaceutical agent to the container, and

drive the communication element to transmit to the container data carrier (a) the SPECT the imaging protocol information, for use by the imaging control unit for driving the camera to perform steps of an imaging procedure, and (b) at least a portion of the patient information;

wherein the imaging system is configured to receive the SPECT imaging protocol information from the container data carrier, and

wherein the imaging control unit is configured to drive the camera to perform the imaging procedure responsively to the SPECT imaging protocol information received from the container data carrier.

18. The apparatus according to claim 17, wherein the pharmacologic kinetic parameter is selected from the group of pharmacologic kinetic parameters consisting of:

an accumulation/redistribution of the at least one labeled radiopharmaceutical agent in tissue, a metabolic rate of the at least one labeled radiopharmaceutical agent, a diffusion coefficient of the at least one labeled radiopharmaceutical agent from blood to tissue, and a diffusion coefficient of the at least one labeled radiopharmaceutical agent from the tissue to the blood.

19. Apparatus for use with a container, the apparatus comprising:

a mother vial having a volume of at least 10 ml, which contains at least 5 ml of a non-diluted labeled radiopharmaceutical agent, and at least 5 ml of saline solution; and

an automated radiopharmaceutical dispensing system, configured to contain the mother vial, and to dispense at least one dose from the mother vial to the container.

20. The apparatus according to claim 19, wherein the mother vial has a volume of at least 20 ml.

21. A method for use with a container and a computer-communicatable container data carrier physically coupled to the container, the method comprising:

receiving, by an automated radiopharmaceutical dispensing system, imaging protocol information indicative of steps of an imaging procedure, for use with at least one labeled radiopharmaceutical agent;

receiving, by the dispensing system, patient information regarding a patient;

automatically robotically dispensing, by the dispensing system, a dose of the at least one labeled radiopharmaceutical agent to the container;

transmitting to the container data carrier, by the dispensing system, (a) the imaging protocol information indicative of the steps of the imaging procedure to be performed by an imaging system and (b) at least a portion of the patient information;

reading the imaging protocol information from the container data carrier; and

performing, by the imaging system, the steps of the imaging procedure responsively to the imaging protocol information read from the container data carrier.

22. The method according to claim 21, wherein receiving the imaging protocol information comprises receiving the imaging protocol information regarding a plurality of labeled radiopharmaceutical agents, and wherein dispensing comprises dispensing respective doses of the labeled radiopharmaceutical agents to the container.

23. The method according to claim 21,

wherein receiving the imaging protocol information indicative of the steps of the imaging procedure comprises receiving an identifier of an imaging protocol assigned to the patient for performance using the dose,

wherein transmitting comprises transmitting the imaging protocol identifier to the container data carrier, and

wherein performing the steps of the imaging procedure comprises performing the steps of the imaging procedure responsively to the identifier of the imaging protocol read from the container data carrier.

24. The method according to claim 21, wherein transmitting comprises transmitting to the container data carrier at least one of:

a time of dispensing of the at least one labeled radiopharmaceutical agent to the container, and information regarding a radioactivity of the dose at the time of dispensing.

25. The method according to claim 21, wherein receiving the radiopharmaceutical information comprises:

providing, to the dispensing system, a mother vial that contains the at least one labeled radiopharmaceutical agent prior to dispensing thereof, and a computer-communicatable mother vial data carrier associated with the mother vial, which mother vial data carrier contains the imaging protocol information; and

receiving the imaging protocol information from the mother vial data carrier.

26. The method according to claim 25, wherein providing the mother vial and the mother vial data carrier comprises providing the mother vial data carrier physically coupled to the mother vial.

27. The method according to claim 21, wherein receiving the imaging protocol information comprises receiving SPECT imaging protocol information.

28. The method according to claim 21, further comprising receiving authenticatable information regarding a commercial license for use of the imaging protocol information with the at least one labeled radiopharmaceutical agent.

29. The method according to claim 28, wherein receiving the information regarding the commercial license comprises receiving information regarding the commercial license for use of a SPECT imaging protocol with the at least one labeled radiopharmaceutical agent.

30. The method according to claim 28, wherein dispensing comprises authenticating the authenticatable license information, and dispensing the dose only upon authentication.

31. The method according to claim 21,

wherein receiving the imaging protocol information indicative of the steps of the imaging procedure comprises receiving instructions for performing the imaging procedure using the at least one labeled radiopharmaceutical agent,

wherein transmitting comprises transmitting the instructions to the container data carrier, and

wherein performing the steps of the imaging procedure comprises executing the instructions of the imaging protocol information.

32. A method for use with a container and a computer-communicatable container data carrier physically coupled to the container, the method comprising:

receiving, by an automated radiopharmaceutical dispensing system, SPECT imaging protocol information that includes at least one pharmacologic kinetic parameter of at least one labeled radiopharmaceutical agent, for use with the at least one labeled radiopharmaceutical agent;

receiving, by the dispensing system, patient information regarding a patient;

automatically robotically dispensing, by the dispensing system, a dose of the at least one labeled radiopharmaceutical agent to the container;

transmitting to the container data carrier, by the dispensing system, (a) the SPECT imaging protocol information to be performed by an imaging system and (b) at least a portion of the patient information;

reading the SPECT imaging protocol information from the container data carrier; and

performing, by the imaging system, an imaging procedure responsively to the SPECT imaging protocol information read from the container data carrier.

33. The method according to claim 32, wherein the pharmacologic kinetic parameter is selected from the group of pharmacologic kinetic parameters consisting of:

an accumulation/redistribution of the at least one labeled radiopharmaceutical agent in tissue, a metabolic rate of the at least one labeled radiopharmaceutical agent, a diffusion coefficient of the at least one labeled radiopharmaceutical agent from blood to tissue, and a diffusion coefficient of the at least one labeled radiopharmaceutical agent from the tissue to the blood.

34. A method for automatically dispensing a labeled radiopharmaceutical agent to a container, comprising:

providing a mother vial having a volume of at least 10 ml;

filling the mother vial with at least 5 ml of a non-diluted labeled radiopharmaceutical agent, and with at least 5 ml of saline solution;

placing the mother vial in an automated radiopharmaceutical dispensing system; and

dispensing at least one dose from the mother vial to the container.

35. The method according to claim 34, wherein proving the mother vial comprises providing the mother vial having a volume of at least 20 ml.