Radiopharmaceutical administration methods, fluid delivery systems and components thereof

• US 20080177126A1
• Filed: 10/31/2007
• Published: 07/24/2008
• Est. Priority Date: 01/01/2007
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Miller, Paul J., Neff, Jared E., Shigeno, James H., Rygg, Steven C., Bisegna, Joseph E., Tate, Leon J., Griffith, Scott R., Yanke, Scott, Ilgenfritz, Edward
• Granted Patent: US 9,056,164 B2
• Time in Patent Office: Days
• US Class Current: 600/5
• CPC Class Codes: A61K 51/00 Preparations containing radioactive substances for use in therapy or testing in vivo
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/16822 by controlling air intake into infusion reservoir needle sets with air inlet A61M5/162
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A fluid path set for a fluid delivery system includes a tube coil that is designed to optimally position one or more volumes of a pharmaceutical within an ionization chamber to optimally measure and prepare a pharmaceutical dose for administration to a patient. The tube coil may be maintained in a desired dimensional geometry by means of a core structure around which the tube coil is positioned. Novel developments in radiopharmaceutical administration methods and systems include, but are not limited to, the configuration and layout of a fluid path set for use in a fluid delivery system, arrangements for piercing and drawing fluid from a pharmaceutical container (such as a vial), arrangements for optimizing the positioning of a tube coil within an ionization chamber, a handling system for transporting vial shields that maintain an operator'"'"'s hand and fingers at a safe distance from a pharmaceutical vial, a method for calibrating a radiopharmaceutical delivery system in which the difference between the expected and measured activities of two radioisotopes are used to calculate an estimated error in the measured activity of a third radioisotope and a vial access system that ensures an optimal draw of fluid from a radiopharmaceutical container.

Claims

1. A fluid path set for use in a fluid delivery system, the fluid path set comprising:

a medical fluid component comprising a first tubing section for connection to a source of a medical fluid;

a pharmaceutical component comprising a second tubing section for connection to a source of a pharmaceutical;

a coil assembly component comprising a tube coil having a height of approximately 1.53 inches, a diameter of approximately 1.95 inches and a volume capacity of approximately 12.5 ml; and

a connector comprising a first port for connecting the first tubing section of the medical fluid component, a second port for connecting the second tubing section of the pharmaceutical component and a third port for connecting the tube coil of the coil assembly component.

2. The fluid path set of claim 1 wherein the tube coil comprises a tubing section having an outer diameter of approximately 0.218 inches, an inner diameter of approximately 0.156 inches and a length of approximately 41 inches.

3. The fluid path set of claim 2 wherein the tube coil is formed in a helical coil of approximately 7 turns of the tubing section.

4. The fluid path set of claim 3 wherein the coil assembly further comprises a core structure around which the tube coil is formed, the core structure comprising an upper shoulder and a lower shoulder that define a tube channel therebetween, the upper and lower shoulders adapted to retain the tube coil therebetween within the tube channel.

5. The fluid path set of claim 4 wherein the core structure further comprises an upper surface defining an inlet for accommodating a first end of the tubing section and an outlet for accommodating a second end of the tubing section.

6. The fluid path set of claim 5 wherein the coil assembly component further comprises a third tubing section connected to the third port of the connector and the first end of the tubing section and a fourth tubing section connected to the second end of the tubing section.

7. The fluid path set of claim 6, further comprising:

a waste component comprising a fifth tubing section in connection with a waste receptacle;

a sixth tubing section having a connector end that is adapted to be connected to a single-patient tubing set; and

a second connector comprising a first port for connecting the fourth tubing section of the coil assembly component, a second port for connecting the fifth tubing section of the waste component and a third port for connecting the sixth tubing section.

8. The fluid path set of claim 7 wherein the connector end comprises a swabable luer valve that is biased to a closed position when the single-patient tubing set is not connected thereto.

9. The fluid path set of claim 7 wherein the connector end comprises a manifold or a stopcock each having two or more outlet ports for connection to respective single-patient tubing sets.

10. The fluid path set of claim 7 wherein the first tubing section is approximately 56.75 inches in length and has an outer diameter of approximately 0.188 inches, an inner diameter of approximately 0.062 inches and a durometer of 45, the second tubing section is approximately 8.75 inches in length and has an outer diameter of approximately 0.094 inches, an inner diameter of approximately 0.032 inches and a durometer of 45, the third tubing section is approximately 15 inches in length and has an outer diameter of approximately 0.163 inches, an inner diameter of approximately 0.062 inches and a durometer of 60, the fourth tubing section is approximately 12 inches in length and has an outer diameter of approximately 0.163 inches, an inner diameter of approximately 0.062 inches and a durometer of 60, and the fifth tubing section and the sixth tubing section are each approximately 5 inches in length and have an outer diameter of approximately 0.163 inches, an inner diameter of approximately 0.062 inches and a durometer of 60.

11. The fluid path set of claim 1 wherein the first tubing section comprises a first check valve and a spike for connecting to the source of a medical fluid and the second tubing section comprises a second check valve and a vented cannula for connecting to the source of a pharmaceutical.

12. The fluid path set of claim 1 wherein the second tubing section comprises a vented cannula comprising:

a main hub comprising two opposed lateral sides and defining a fluid port and a vent;

a fluid draw needle in connection with the second tubing section through the fluid port and adapted to be placed within the source of a pharmaceutical;

a vent needle in connection with the vent and adapted to be placed within the source of a pharmaceutical; and

two resilient arms connected to the opposed lateral sides of the main hub, each of the two arms comprising a top edge and a hook member formed thereon and extending outwardly therefrom.

13. The fluid path set of claim 12 wherein the fluid draw needle is longer than the vent needle.

14. The fluid path set of claim 12 wherein the vent comprises a filter.

15. The fluid path set of claim 12 wherein the main hub of the vented cannula further comprises a ledge extending therefrom in a horizontal plane above the two arms, the ledge and the top edges of the two arms cooperating to define horizontal slots therebetween.

16. The fluid path set of claim 15 wherein the hook members extend outwardly from the arms in a plane substantially normal to the horizontal plane of the ledge.

17. The fluid path set of claim 12 wherein the main hub and each of the arms cooperate to define substantially U-shaped grooves extending along the lateral sides of the main hub.

18. A vented cannula for drawing fluid from a container, the vented cannula comprising:

a main hub comprising two opposed lateral sides and defining a fluid port and a vent;

a fluid draw needle in connection with the fluid port and adapted to be placed within the container;

a vent needle in connection with the vent and adapted to be placed within the container; and

two resilient arms connected to the opposed lateral sides of the main hub, each of the two arms comprising a top edge and a hook member formed thereon and extending outwardly therefrom.

19. The vented cannula of claim 18 wherein the fluid draw needle is longer than the vent needle.

20. The vented cannula of claim 18 wherein the vent comprises a filter.

21. The vented cannula of claim 18 wherein the main hub of the vented cannula further comprises a ledge extending therefrom in a horizontal plane above the two arms, the ledge and the top edges of the two arms cooperating to define horizontal slots therebetween.

22. The vented cannula of claim 21 wherein the hook members extend outwardly from the arms in a plane substantially normal to the horizontal plane of the ledge.

23. The vented cannula of claim 18 wherein the main hub and each of the arms cooperate to define substantially U-shaped grooves extending along the lateral sides of the main hub.

24. A method of calibrating a fluid delivery system for delivering a pharmaceutical containing a radioisotope to a patient, the method comprising:

measuring an activity level of a first radioisotope in an ionization chamber of the fluid delivery system, the first radioisotope having an energy level less than that of the radioisotope to be delivered to the patient;

comparing the measured activity level of the first radioisotope to an expected activity level of the first radioisotope;

adjusting the gain of the ionization chamber to compensate for the difference, if any, between the measured activity and the expected activity of the first radioisotope;

measuring an activity level of a second radioisotope in the ionization chamber of the fluid delivery system, the second radioisotope having an energy level similar to or greater than that of the radioisotope to be delivered to the patient;

comparing the measured activity level of the second radioisotope to an expected activity level of the second radioisotope;

adjusting the gain of the ionization chamber to compensate for the difference, if any, between the measured activity and the expected activity of the second radioisotope; and

calculating an estimated en-or in a measured activity of a third radioisotope based on the differences, if any, between the measured activity and the expected activity of the first radioisotope and the measured activity and the expected activity of the second radioisotope.

25. The method of claim 24, further comprising:

comparing the estimated error in a measured activity of the third radioisotope to a predetermined acceptable error or error range;

if the estimated error is the same as or similar to the predetermined acceptable error or is within the predetermined acceptable error range, then measuring an activity level of the third radioisotope in the ionization chamber of the fluid delivery system;

calculating the difference, if any, between the measured activity level of the third radioisotope and an expected activity level of the third radioisotope to derive an actual error; and

determining whether the actual error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range.

26. The method of claim 24 wherein the calculating step comprises:

calculating an initial estimated error in a measured activity of a third radioisotope based on the difference, if any, between the measured activity and the expected activity of the first radioisotope; and

calculating a revised estimated error in a measured activity of the third radioisotope based on the difference, if any, between the measured activity and the expected activity of the second radioisotope.

27. The method of claim 26, further comprising:

comparing the revised estimated en-or in a measured activity of the third radioisotope to a predetermined acceptable error or error range;

if the revised estimated error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range, then measuring an activity level of the third radioisotope in the ionization chamber of the fluid delivery system;

calculating the difference, if any, between the measured activity level of the third radioisotope and an expected activity level of the third radioisotope to derive an actual error; and

determining whether the actual error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range.

28. The method of claim 27, further comprising:

if the revised estimated error is not the same or similar to the predetermined acceptable error or is not within the predetermined acceptable error range, then remeasuring the activity level of the first radioisotope in the ionization chamber of the fluid delivery system;

comparing the remeasured activity level of the first radioisotope to the expected activity level of the first radioisotope;

adjusting the gain of the ionization chamber to compensate for the difference, if any, between the remeasured activity and the expected activity of the first radioisotope;

calculating a second revised estimated error in a measured activity of the third radioisotope based on the difference, if any, between the remeasured activity and the expected activity of the first radioisotope;

remeasuring the activity level of the second radioisotope in the ionization chamber of the fluid delivery system;

comparing the remeasured activity level of the second radioisotope to the expected activity level of the second radioisotope;

adjusting the gain of the ionization chamber to compensate for the difference, if any, between the remeasured activity and the expected activity of the second radioisotope; and

calculating a third revised estimated error in a measured activity of the third radioisotope based on the difference, if any, between the remeasured activity and the expected activity of the second radioisotope.

29. The method of claim 28, further comprising:

comparing the third revised estimated error in a measured activity of the third radioisotope to a predetermined acceptable error or error range;

if the third revised estimated error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range, then measuring an activity level of the third radioisotope in the ionization chamber of the fluid delivery system;

calculating the difference, if any, between the measured activity level of the third radioisotope and an expected activity level of the third radioisotope to derive an actual error; and

determining whether the actual error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range.

30. The method of claim 27, further comprising:

if the revised estimated error is not the same or similar to the predetermined acceptable error or is not within the predetermined acceptable error range, then remeasuring the activity level of the first radioisotope in the ionization chamber of the fluid delivery system;

comparing the remeasured activity level of the first radioisotope to the expected activity level of the first radioisotope;

adjusting the gain of the ionization chamber to compensate for the difference, if any, between the remeasured activity and the expected activity of the first radioisotope;

calculating a second revised estimated error in a measured activity of the third radioisotope based on the difference, if any, between the remeasured activity and the expected activity of the first radioisotope;

comparing the second revised estimated error in a measured activity of the third radioisotope to a predetermined acceptable error or error range;

if the second revised estimated error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range, then measuring an activity level of the third radioisotope in the ionization chamber of the fluid delivery system;

calculating the difference, if any, between the measured activity level of the third radioisotope and an expected activity level of the third radioisotope to derive an actual error;

determining whether the actual error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range;

if the second revised estimated error is not the same or similar to the predetermined acceptable error or is not within the predetermined acceptable error range, then remeasuring the activity level of the second radioisotope in the ionization chamber of the fluid delivery system;

comparing the remeasured activity level of the second radioisotope to the expected activity level of the second radioisotope;

adjusting the gain of the ionization chamber to compensate for the difference, if any, between the remeasured activity and the expected activity of the second radioisotope; and

calculating a third revised estimated error in a measured activity of the third radioisotope based on the difference, if any, between the remeasured activity and the expected activity of the second radioisotope.

31. The method of claim 30, further comprising:

comparing the third revised estimated error in a measured activity of the third radioisotope to a predetermined acceptable error or error range;

if the third revised estimated error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range, then measuring an activity level of the third radioisotope in the ionization chamber of the fluid delivery system;

calculating the difference, if any, between the measured activity level of the third radioisotope and an expected activity level of the third radioisotope to derive an actual error; and

determining whether the actual error is the same or similar to the predetermined acceptable error or is within the predetermined acceptable error range.

32. The method of claim 24 wherein the radioisotope to be delivered to the patient is F-18.

33. The method of claim 32 wherein the first radioisotope is Co-57, the second radioisotope is Co-60 and the third radioisotope is Cs-137.

34. The method of claim 24 wherein the low gain of the ionization chamber is adjusted to compensate for the difference, if any, between the measured activity and the expected activity of the first radioisotope and the high gain of the ionization chamber is adjusted to compensate for the difference, if any, between the measured activity and the expected activity of the second radioisotope.

35. A vial access system comprising:

a base portion comprising a substantially horizontal lower surface and a sloped upper surface adapted to support a vial comprising a bottom wall and a substantially cylindrical wall connected thereto, the sloped upper surface adapted to ensure that a residual volume of fluid in the vial gathers in an area defined at least partially by a portion of the junction between the bottom wall and the cylindrical wall of the vial.

36. The vial access system of claim 35, further comprising:

a housing extending vertically from the base portion;

a vertical support arm comprising an upper end, the vertical support arm movably disposed within the housing; and

a cap member connected to the upper end of the vertical support arm and adapted to overlie a septum of the vial.

37. The vial access system of claim 36 wherein the cap member comprises a mounting mechanism disposed on an underside thereof, the mounting mechanism adapted to retain a cannula therein for insertion through the septum of the vial.

38. The vial access system of claim 37 wherein the vertical support arm is slidably disposed within the housing to allow the cannula to be inserted into and removed from the vial.

39. The vial access system of claim 38 wherein the vertical support arm is rotatably disposed within the housing to allow the cap member to be rotated into and out of a position that overlies the septum of the vial.

40. The vial access system of claim 37 wherein the mounting mechanism comprises two arms that cooperate to define a slot therebetween, each of the two arms comprising a tab member extending downwardly therefrom, each of the tab members comprising a front edge and a rear edge.

41. The vial access system of claim 36, further comprising a handle member pivotally connected to the upper end of the vertical support arm.

42. The vial access system of claim 36 wherein the cap member includes or is formed from radioactive shielding material.

43. The vial access system of claim 35, further comprising at least one support member connected to the base portion for retaining the vial on the sloped upper surface of the base portion.

44. The vial access system of claim 43 wherein the at least one support member comprises two support pins that are connected to the sloped upper surface of the base portion.

45. The vial access system of claim 35 wherein the vial is contained within a vial shield and the fluid is a radiopharmaceutical.

46. The vial access system of claim 35 wherein the sloped upper surface is sloped at an angle of approximately 10-13 degrees with respect to a horizontal plane.

47. A method of priming at least a portion of a fluid path set in a fluid delivery system, the method comprising:

placing a tubing section of the fluid path set in fluid connection with a source of a radiopharmaceutical;

placing a portion of the tubing section within a dose calibrator of the fluid delivery system;

pumping a volume of the radiopharmaceutical through the tubing section;

monitoring the dose calibrator to determine if a measured activity level is substantially equal to or above a predetermined activity level; and

if the measured activity level is substantially equal to or above the predetermined activity level, then concluding that the tubing section of the fluid path set has been primed.

48. The method of claim 47, further comprising:

if the measured activity level is zero or below the predetermined activity level, then concluding that the tubing section of the fluid path has not been primed; and

pumping a second volume of the radiopharmaceutical through the tubing section.

49. The method of claim 47, further comprising:

placing a second tubing section in fluid connection with a source of medical fluid and the tubing section;

pumping a volume of the medical fluid through the second tubing section and at least a portion of the tubing section to move the volume of the radiopharmaceutical to the portion of the tubing section that is positioned within the dose calibrator.

50. The method of claim 49, further comprising:

placing the tubing section in fluid connection with a waste receptacle;

pumping a second volume of the medical fluid through the second tubing section and at least a portion of the tubing section to move the volume of the radiopharmaceutical into the waste receptacle.

51. A fluid delivery system, comprising:

a housing having an upper surface defining a plurality of recessed portions for accommodating one or more components of a fluid path set;

a cover movably connected to the housing and adapted to move between a first position that exposes the upper surface and a second position that overlies the upper surface; and

.

a locking mechanism associated with the cover and adapted to lock the cover in the second position.

52. The fluid delivery system of claim 51 wherein the cover is slidably connected to the housing.

53. The fluid delivery system of claim 51 wherein the first position allows an operator to insert or remove the one or more components of the fluid path set.

54. The fluid delivery system of claim 51 wherein the plurality of recessed portions includes wells and troughs.

55. The fluid delivery system of claim 51, further comprising:

one or more handles connected to the housing;

a plurality of wheels or casters connected to the housing; and

a display connected to the housing.

56. The fluid delivery system of claim 51 wherein the cover and the upper surface comprises or is formed from a radioactive shielding material.

57. The fluid delivery system of claim 51, further comprising:

a dose calibrator for measuring the radioactivity level of a radiopharmaceutical;

a pumping mechanism for pumping the radiopharmaceutical; and

a controller in communication with the dose calibrator and the pumping mechanism.

58. The fluid delivery system of claim 51 wherein the locking mechanism comprises a mechanical lock that locks the cover to the housing in the second position.

59. The fluid delivery system of claim 57 wherein the locking mechanism is a software-implemented lock that is in communication with the controller, the software implemented lock adapted to lock the cover to the housing in the second position.

60. The fluid delivery system of claim 51, further comprising a printer associated with the housing.

61. A vial shield carrying system for carrying a vial shield containing a pharmaceutical vial, the vial shield carrying system comprising in combination:

a collar unit adapted to removably engage a flange on the vial shield, the collar unit defining two elongated slots formed in a top surface thereof, each of the slots including a pin disposed therein and extending between two opposing walls thereof; and

a handle unit adapted to engage the collar unit, the handle unit comprising a handle connected to a U-shaped cross piece defining two, downwardly extending arms having hook members formed therein, the open ends of the hook members formed on opposite ends of the arms and adapted to engage the pins in the slots of the collar unit through rotation of the handle.

62. The vial shield carrying system of claim 61, further comprising a plunger connected to the U-shaped cross piece and adapted to mate with a septum cap of the vial shield when the handle unit engages the collar unit on the vial shield.

63. The vial shield carrying system of claim 62, further comprising a spring disposed between the plunger and the U-shaped cross piece, the spring adapted to bias the plunger into engagement with the septum cap of the vial shield.

64. The vial shield carrying system of claim 63 wherein the arms are lowered into the slots of the collar unit, the plunger is engaged with the septum cap of the vial shield and the handle is rotated in a clockwise direction to seat the pins of the collar unit in the hook members of the handle unit.

65. The vial shield carrying system of claim 64 wherein the handle is rotated in a counter-clockwise direction to disengage the hook members of the handle unit from the pins of the collar unit.

66. The vial shield carrying system of claim 62 wherein the plunger comprises or is formed from a radioactive shielding material.

67. The vial shield carrying system of claim 61 wherein the collar unit comprises two members that are pivotally connected to allow the collar unit to engage and disengage the flange of the vial shield.

68. A fluid delivery system, comprising:

a syringe comprising a body defining a discharge outlet and a plunger movably disposed within the body;

a connector comprising a valve member and defining first, second and third ports;

a first tubing segment connected between the discharge outlet of the syringe and the first port of the connector;

a cannula defining a fluid port;

a second tubing segment connected between the fluid port of the cannula and the second port of the connector;

a third tubing segment comprising a first end connected to the third port of the connector and a second end comprising a second connector; and

a per-patient tubing set comprising a first end that is adapted to be connected to the second connector on the second end of the third tubing segment and a patient end that is adapted to be connected to venous access device in a patient.

69. The fluid delivery system of claim 68 wherein the connector comprises a T-connector and the valve member comprises a stopcock.

70. The fluid delivery system of claim 68 wherein the second connector comprises a swabable valve or a luer connector.

71. The fluid delivery system of claim 68 wherein the syringe contains a radiopharmaceutical and is disposed within a lead-shielded container.

72. The fluid delivery system of claim 68 wherein the syringe is a hand-held syringe.

73. The fluid delivery system of claim 68 wherein the cannula further comprises:

a main hub comprising two opposed lateral sides and defining a vent;

a fluid draw needle in connection with the fluid port and adapted to be placed within a fluid container;

a vent needle in connection with the vent and adapted to be placed within the fluid container; and

two resilient arms connected to the opposed lateral sides of the main hub, each of the two arms comprising a top edge and a hook member formed thereon and extending outwardly therefrom.