DEVICES, SYSTEMS AND METHODS FOR DETERMINING PARAMETERS OF ONE OR MORE PHASES OF AN INJECTION PROCEDURE

• US 20070282263A1
• Filed: 11/23/2005
• Published: 12/06/2007
• Est. Priority Date: 11/24/2004
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Kalafut, John, Mishler, David
• Granted Patent: US 7,925,330 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A fluid injection apparatus includes at least one pressurizing mechanism and at least a first fluid container (for example, a syringe or a bulk container) operably associated with the at least one pressurizing mechanism. The first fluid container is adapted to contain a first fluid to be injected. The fluid injection apparatus also includes a controller operably associated with the at least one pressurizing mechanism. The controller includes a programming system to allow programming of an injection protocol including, for example, a plurality of phases. At least one parameter generator is provided to determine parameters of at least one of the plurality of phases of the protocol based at least in part upon a type of the injection procedure.

Claims

1. A fluid injection apparatus comprising:

at least one pressurizing mechanism;

at least a first fluid container operably associated with the at least one pressurizing mechanism, the first fluid container being adapted to contain a first fluid to be injected;

a controller operably associated with the at least one pressurizing mechanism, the controller comprising a programming system to allow programming of an injection protocol comprising a plurality of phases; and

at least one parameter generator to determine parameters of at least one of the plurality of phases based at least in part upon a type of the injection procedure.

2. The fluid injection apparatus of claim 1 further comprising:

at least a second fluid container operably associated with the at least one pressurizing mechanism, the second fluid container adapted to contain a second fluid; and

the plurality of phases comprising at least one phase in which the first fluid is injected and at least one phase in which the second fluid is injected.

3. The fluid injection apparatus of claim 2 wherein the first fluid is a contrast medium and the second fluid is a non-contrast-enhancing fluid.

4. The fluid injection apparatus of claim 3 wherein the parameter generator is adapted to generate parameters based upon at least one additional variable.

5. The fluid injection apparatus of claim 4 wherein the at least one additional variable is a concentration of a contrast enhancing agent within the contrast medium or a patient specific physiological variable.

6. The fluid injection apparatus of claim 5 wherein the contrast enhancing agent is iodine or gadolinium.

7. The fluid injection apparatus of claim 3 wherein the parameters for each phase for each of the first fluid and the second fluid include a volume to be injected and a flow rate profile for injection of the volume.

8. The fluid injection apparatus of claim 3 wherein the control system provides a choice to an operator as to whether to program the parameters manually or to have the parameters programmed by the parameter generator

9. The fluid injection apparatus of claim 3 wherein parameters programmed by the parameter generator can be changed manually by an operator.

10. The fluid injection apparatus of claim 3 wherein an operator chooses a type of injection procedure from a plurality of predefined types of injection procedures.

11. The fluid injection apparatus of claim 10 wherein a graphical representation of regions of a patient is provided to an operator for selection of a region to be imaged, the selected region to be imaged defining the type of injection procedure.

12. The fluid injection apparatus of claim 10 wherein a list of regions of a patient is provided to an operator for selection of a region to be imaged, the selected region to be imaged defining the type of injection procedure.

13. The fluid injection apparatus of claim 3 wherein an operator is provided with a choice of an algorithm from a plurality of algorithms adapted to be used by the parameter generator to generate the parameters.

14. The fluid injection apparatus of claim 3 wherein the at least one phase of the plurality of phases includes injection of an admixture of contrast enhancing fluid and non-contrast enhancing fluid.

15. The fluid injection apparatus of claim 3 wherein the parameter generator generate parameters for at least one phase at least in part on the basis of a test injection.

16. The fluid injection apparatus of claim 14 wherein the parameter generator determines parameters for at least one phase at least in part on the basis of time to peak enhancement determined in a test injection.

17. The fluid injection apparatus of claim 16 wherein a ratio of contrast enhancing fluid to non-contrast enhancing fluid is determined by the parameter generator on the basis of time to peak enhancement.

18. The fluid injection apparatus of claim 17 wherein a longer time to peak enhancement results in a higher ratio of contrast enhancing fluid to non-contrast enhancing fluid.

19. The fluid injection apparatus of claim 1 further comprising:

a user interface system comprising an input mechanism via which an operator can input at least one of an input protocol or an output enhancement curve, the user interface system further comprising a display; and

at least one model adapted to provide at least one of a calculated output enhancement curve if the user inputs an input protocol or a calculated input protocol if the user inputs an output enhancement curve.

20. The fluid injection apparatus of claim 19 wherein the operator draws the input protocol or the output enhancement curve on a component of the user interface system.

21. The fluid injection apparatus of claim 19 wherein the operator draws the input protocol or the output enhancement curve on a component of the display of the user interface system.

22. The fluid injection apparatus of claim 14 wherein the concentration of an active agent present in the contrast enhancement fluid injected into the patient is decreased in at least one phase while the flow rate of fluid injected into the patient is maintained generally constant.

23. The fluid injection apparatus of claim 22 wherein the concentration of an active agent present in the contrast enhancement fluid injected into the patient is decreased continuously over a period of time while flow rate is maintained generally constant.

24. The fluid injection apparatus of claim 1 wherein parameters are changed to effect enhancement of more than one region of interest over a duration of an imaging procedure.

25. The fluid injection apparatus of claim 14 wherein parameters of the at least one phase of the plurality of phases including injection of an admixture of contrast enhancing fluid and non-contrast enhancing fluid are chosen to effect enhancement of more than one region of interest over a duration of an imaging procedure.

26. The fluid injection apparatus of claim 25 wherein one region of interest is a left compartment of the heart and another region of interest is a right compartment of the heart.

27. The fluid injection apparatus of claim 25 wherein one region of interest is a first portion of the liver and a second region of interest is another portion of the liver.

28. The fluid injection apparatus of claim 14 wherein the parameter generator generate parameters for at least one phase at least in part on the basis of time to peak enhancement determined in a test injection.

29. The fluid injection apparatus of claim 28 wherein a ratio of contrast enhancing fluid to non-contrast enhancing fluid is determined by the parameter generator on the basis of time to peak enhancement.

30. The fluid injection apparatus of claim 29 wherein a longer time to peak enhancement results in a higher ratio of contrast enhancing fluid to non-contrast enhancing fluid.

31. The fluid injection apparatus of claim 14 further comprising:

a user interface system comprising an input mechanism via which an operator can input at least one of an input protocol or an output enhancement curve, the user interface system further comprising a display; and

at least one model adapted to provide at least one of a calculated output enhancement curve if the user inputs an input protocol or a calculated input protocol if the user inputs an output enhancement curve.

32. The fluid injection apparatus of claim 31 wherein the operator draws the input protocol or the output enhancement curve on a component of the user interface system.

33. The fluid injection apparatus of claim 1 further comprising a workflow system comprising a display setting forth graphically a representation of the steps required to initiate an injection procedure.

34. The fluid injection apparatus of claim 33 wherein the operator can select a step representation to complete ancillary operations required in the selected step.

35. The fluid injection apparatus of claim 33 wherein the display sets forth the graphical representation of the steps in a suggested sequential order.

36. The fluid injection apparatus of claim 14 further comprising a workflow system comprising a display setting forth graphically a representation of the steps required to initiate an injection procedure.

37. The fluid injection apparatus of claim 36 wherein the operator can select a step representation to complete ancillary operations required in the selected step.

38. The fluid injection apparatus of claim 36 wherein the display sets forth the graphical representation of the steps in a suggested sequential order.

39. The fluid injection apparatus of claim 3 further comprising:

a system for determining a pressure to be generated during at least one of the phases based upon at least one of the parameters of the phase.

40. The fluid injection apparatus of claim 39 further comprising a mechanism to indicate if the pressure to be generated during the at least one of the phases is in excess of a pressure threshold.

41. The fluid injection apparatus of claim 3 wherein the programming system comprises a computer and the parameter generator comprises software stored in a computer memory.

42. An imaging system comprising:

an imaging device and;

a fluid injection apparatus comprising;

at least one pressurizing mechanism;

at least a first fluid container operably associated with the at least one pressurizing mechanism, the first fluid container being adapted to contain a first fluid to be injected;

a controller operably associated with the at least one pressurizing mechanism, the controller comprising a programming system to allow programming of an injection protocol comprising a plurality of phases; and

at least one parameter generator to determine parameters of at least one of the plurality of phases based at least in part upon a type of the injection procedure.

43. The system of claim 42 wherein the fluid injection apparatus further comprises:

at least a second fluid container operably associated with the at least one pressurizing mechanism, the second fluid container adapted to contain a second fluid; and

the plurality of phases for the injection protocol comprising at least one phase in which the first fluid is injected and at least one phase in which the second fluid is injected.

44. A method of delivering fluid to a patient comprising the steps:

providing at least one pressurizing mechanism;

providing at least a first fluid container operably associated with the at least one pressurizing mechanism, the first fluid container being adapted to contain a first fluid to be injected;

providing a controller operably associated with the at least one pressurizing mechanism, the controller comprising a programming system to allow programming of an injection protocol comprising a plurality of phases; and

determining at least one parameter of at least one of the plurality of phases via a parameter generator based at least in part upon a type of the injection procedure.

45-51. -51. (canceled)

52. A fluid injection apparatus comprising:

at least one pressurizing mechanism;

at least a first fluid container operably associated with the at least one pressurizing mechanism, the first fluid container being adapted to contain a first fluid to be injected; and

a workflow system comprising a display setting forth graphically a representation of the steps required to initiate an injection procedure.

53. The fluid injection apparatus of claim 52 wherein the operator can select a step representation to complete ancillary operations required in the selected step.

54. The fluid injection apparatus of claim 52 wherein the display sets forth the graphical representation of the steps in a suggested sequential order.

55. A fluid injection apparatus comprising:

at least one pressurizing mechanism;

at least a first fluid container operably associated with the at least one pressurizing mechanism, the first fluid container being adapted to contain a first fluid to be injected;

a controller operably associated with the at least one pressurizing mechanism, the controller comprising a programming system to allow programming of an injection protocol comprising at least one phase; and

a user interface system comprising an input mechanism via which an operator can input at least one of an input protocol or an output enhancement curve, the user interface system further comprising a display; and

at least one model adapted to provide at least one of a calculated output enhancement curve if the user inputs an input protocol or a calculated input protocol if the user inputs an output enhancement curve.

56. The fluid injection apparatus of claim 55 wherein the calculated output enhancement curve or the calculated input protocol is displayed on the display.