Apparatus and methods for delivery of fluid injection boluses to patients and handling harmful fluids

• US 9,056,200 B2
• Filed: 06/05/2009
• Issued: 06/16/2015
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Medical Care Inc. (Bayer AG)
• Inventors: Uber, Arthur E. III, Trocki, Mark, Mabie, Marc A., McCutchan, Larry, Siddoway, L. George, Cowan, Kevin P., Coates, Lisa M., Kalafut, John F., Hughes, Aaron, Griffiths, David M., Twichell, Peter, Gulick, Julie, Trombley, Frederick W. III
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/996,520
• Publication Number:
  US 20110209764A1
• Time in Patent Office: 2,202 Days
• Field of Search: 600/5, 137/1, 220/501, 604/19
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 2206/11 Laminar flow
• CPC Class Codes: A61M 2206/18 Coaxial flows, e.g. one flow within another
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1785 comprising radioactive shield means syringe shields or holders for storage of radioactive sources G21F5/018
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: Y10T 137/0318 Processes

Abstract

A hazardous fluid transport container and a hazardous fluid delivery system are disclosed. The hazardous fluid transport container includes a housing enclosing an at least partially shielded enclosure. First and second fluid path elements are disposed within the housing, with the first fluid path element and second fluid path element fluidly coupled together. A pump unit may be provided for dispensing fluid from the first and second fluid path elements optionally into a third fluid path element. Also, methods for priming the hazardous fluid transport container and for mitigating laminar flow injection bolus spreading are disclosed. Additionally, disclosed is a radioactive fluid transport container for a syringe or other container. The radioactive fluid transport container allows the syringe or container to be used in an injection procedure without removal from the container.

Claims

1. A hazardous radioactive fluid transport container, comprising:

a portable housing;

a first fluid path element disposed in the portable housing to conduct a radioactive fluid;

one or more shield elements forming an enclosure surrounding the first fluid path element, each of the one or more shield elements being disposed within the portable housing;

a second fluid path element disposed in the portable housing, wherein the second fluid path element is in fluid connection with the first fluid path element; and

a third fluid path element in fluid connection with the first fluid path element and the second fluid path element, the third fluid path element provided to conduct a flushing fluid;

wherein at least one of the first fluid path element, the second fluid path element, and the third fluid path element is accessible from outside the portable housing,

wherein at least one of the first fluid path element, the second fluid path element, and the third fluid path element comprises coiled tubing paid outward from the portable housing and returned therein, and

wherein the first fluid path element is filled with the radioactive fluid and the third fluid path element is filled with the flushing fluid, both filled via respective connectors for connecting to an outside radioactive fluid source and an outside flushing fluid source, respectively.

2. The radioactive fluid transport container of claim 1, further comprising at least one of a radiation detector and an air detector associated with one or more of the first fluid path element, the second fluid path element, and the third fluid path element.

3. The radioactive fluid transport container of claim 1, further comprising at least one control valve operably connected to one or more of the first fluid path element, the second fluid path element, and the third fluid path element.

4. The radioactive fluid transport container of claim 1, wherein the first fluid path element is a syringe.

16. The radioactive fluid filling and transport system of claim 2, further comprising a control valve in fluid connection with the at least a radioactive fluid source and the first fluid path element.

5. A radioactive fluid delivery system, comprising:

a portable housing enclosing an at least partially radiation shielded enclosure;

a first fluid path element disposed in the shielded enclosure to conduct a radioactive fluid;

a second fluid path element disposed in the portable housing and in fluid connection with the first fluid path element;

a third fluid path element in fluid connection with the first fluid path element and the second fluid path element, the third fluid path element provided to conduct a flushing fluid; and

a pump unit in controlled fluid connection with one or more of the first fluid path element and the third fluid path element, wherein the pump unit is configured to dispense fluid from one or more of the first fluid path element and the third fluid path element,

wherein at least one of the first fluid path element, the second fluid path element, and the third fluid path element comprises coiled tubing paid outward from the portable housing and returned therein, and

wherein the first fluid path element is filled with the radioactive fluid and the third fluid path element is filled with the flushing fluid, both filled via respective connectors for connecting to an outside radioactive fluid source and an outside flushing fluid source, respectively.

6. The radioactive fluid delivery system of claim 5, further comprising at least one of a radiation detector and an air detector associated with one or more of the first fluid path element, the second fluid path element, and the third fluid path element.

7. A method for priming a radiopharmaceutical delivery system and delivering a compact radiopharmaceutical drug bolus to a patient, the method comprising:

delivering a first liquid to a fluid path element;

delivering a fluid separator to the fluid path element;

delivering a radiopharmaceutical drug to the fluid path element whereby the first liquid and the radiopharmaceutical drug are separated by the fluid separator flowing with the first liquid and the radiopharmaceutical drug to maintain separation between the first liquid and the radiopharmaceutical drug for bolus sharpness of the compact radiopharmaceutical drug bolus; and

delivering the compact radiopharmaceutical drug bolus to the patient.

8. The method of claim 7, wherein the first liquid comprises a non-hazardous liquid.

9. The method of claim 7, wherein the fluid separator comprises a gas.

10. The method of claim 9, wherein the gas comprises carbon dioxide.

11. The method of claim 7, wherein the fluid separator comprises a liquid.

12. The method of claim 7, wherein the fluid separator comprises a solid member.

13. A radioactive fluid filling and transport system, comprising:

a radioactive fluid transport container, comprising;

a portable housing;

a first fluid path element disposed in the portable housing to conduct a radioactive fluid;

one or more shield elements forming an enclosure surrounding the first fluid path element, each of the one or more shield elements being disposed within the portable housing;

a second fluid path element disposed in the portable housing and fluidly connected to the first fluid path element; and

a third fluid path element in fluid connection with the first fluid path element and the second fluid path element, the third fluid path element provided to conduct a flushing fluid; and

a filling system comprising at least a radioactive fluid source in reversible fluid connection with at least the first fluid path element;

at least a flushing fluid source in reversible fluid connection with at least the third fluid path element; and

at least one fluid pump associated with one or more of the at least a radioactive fluid source and the at least a flushing fluid source for dispensing fluid from the radioactive fluid source and the flushing fluid source into the first fluid path element and third fluid path element, respectively,

wherein at least one of the first fluid path element, the second fluid path element, and the third fluid path element comprises coiled tubing be paid outward from the housing and returned therein, and

wherein the first fluid path element is filled with the radioactive fluid and the third fluid path element is filled with the flushing fluid, both filled via respective connectors on the first fluid path element and the third fluid path element which are adapted to mate with mating connectors on the filling system.

14. The radioactive fluid filling and transport system of claim 13, wherein the one or more shield elements comprise a radiation shield.

15. The radioactive fluid filling and transport system of claim 13, further comprising at least one of a radiation detector and an air detector associated with one or more of the first fluid path element, the second fluid path element, and the third fluid path element.

17. A system for dispensing pharmaceuticals, comprising:

a transport container comprising;

a portable housing;

a first fluid path element disposed in the portable housing to conduct a radioactive fluid;

one or more shield elements forming an enclosure surrounding the first fluid path element, each of the one or more shield elements being disposed within the portable housing;

a second fluid path element disposed in the portable housing, wherein the second fluid path element is in fluid connection with the first fluid path element; and

a third fluid path element in fluid connection with the first fluid path element and the second fluid path element, the third fluid path element provided to conduct a flushing fluid,

wherein at least one of the first fluid path element, the second fluid path element, and the third fluid path element comprises tubing accessed from outside the housing and paid outward from the housing and returned therein; and

a filling station comprising;

a radioactive fluid source in fluid connection with at least a first filling station fluid path element terminating in a first mating connector configured to reversibly connect to a first connector element on the first fluid path element;

a flushing fluid source in fluid connection with at least a second filling station fluid path element terminating in a second mating connector configured to reversibly connect to a second connector element on the third fluid path element;

one or more fluid pump units; and

a control unit operably connected to the one or more fluid pump units and configured to control the one or more fluid pump units.

18. The system of claim 17, further comprising one or more check valves operably connected to the second fluid path element.

19. The system of claim 17, further comprising one or more control valves fluidly connected to one or more of the at least a first filling station fluid path element, wherein the one or more control valves are operably connected to the control unit.

20. The system of claim 17, further comprising one or more data storage devices associated with one or more of the radioactive fluid source and the flushing fluid source.

21. The system of claim 17, wherein the filling station further comprises a waste container.

22. The system of claim 17, further comprising a carbon dioxide source conduit fluidly connected to a carbon dioxide source and the at least a first filling station fluid path element.

23. The system of claim 17, wherein the first fluid path element is a syringe.