Patient specific dosing contrast delivery systems and methods

• US 20010056233A1
• Filed: 12/29/2000
• Published: 12/27/2001
• Est. Priority Date: 09/21/1994
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Uber, Arthur E. III, Hirschman, Alan D., Almon-Martin, Rosemary, Welch, Thomas R.
• Granted Patent: US 6,889,074 B2
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/80 voice-operated command
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

This invention relates generally to the field of medical devices for delivering contrast media during medical diagnostic and therapeutic imaging procedures and more particularly, this invention relates to improved contrast media delivery systems and methods of use which allow adjustment of contrast media concentration and injection parameters either before or during an injection procedure to provide patient specific dosing of contrast media, thus decreasing the waste and cost of these procedures while increasing their efficiency.

Claims

1. A system for injection of a patient with a fluid medium in a medical procedure, the combination comprising:

(a) a source of a fluid medium at a selected concentration;

(b) pressurizing means in operative association with the fluid medium to pressurize the fluid medium for patient infusion; and

(c) electronic control means operably connected to said pressurizing means capable of setting initial fluid medium pressure based on data characteristic of the patient.

2. The system as defined in

claim 1

, wherein the electronic control means is also capable of adjusting fluid medium pressure during patient infusion.

3. The system as defined in

claim 2

further comprising at least one sensor to provide at least one feedback signal representative of a concentration of the fluid medium in the patient.

4. The system as defined in

claim 3

wherein the sensor includes electromagnetic radiation means producing one or more wavelengths of electromagnetic energy suitable for determining fluid media concentration in the patient.

5. The system as defined in

claim 4

wherein the sensor employs x-ray electromagnetic energy.

6. The system as defined in

claim 5

wherein the sensor employs infrared electromagnetic energy.

7. The system as defined in

claim 3

wherein the system further includes a means for generating a video image of the patient.

8. The system as defined in

claim 7

wherein the system further includes means for generating a real time video image of the patient to provide a feedback signal to an operator.

9. The system as defined in

claim 1

wherein at least one sensor provides a feedback signal representative of a pressure of the fluid medium.

10. The system as defined in

claim 9

wherein the sensor measures internal vessel pressure of a blood vessel in a patient.

11. The system as defined in

claim 9

wherein the sensor produces tactile feedback via a hand syringe in fluid communication with a path of the fluid medium.

12. In a system for injection of a patient with a fluid medium in a medical procedure, the combination comprising:

(a) a source of a fluid medium including a source of contrast medium, a source of diluent, and a mixing means;

(b) pressurizing means in operative association with the fluid medium to pressurize the fluid medium for patient infusion; and

(c) electronic control means capable of calculating an initial flow rate and concentration of fluid medium based on characteristic data of the patient.

13. The system as defined in

claim 12

wherein the electronic control means is operably connected to the pressurizing means and mixing means and wherein the electronic control means is capable of adjusting the pressurizing means to alter the pressure of the fluid medium during patient infusion and is also capable of adjusting the mixing means to alter concentration of the fluid medium during patient infusion.

14. A system as defined in

claim 13

wherein at least one sensor provides a feedback signal representative of a concentration of the fluid medium in the patient.

15. A system as defined in

claim 14

wherein the sensor includes electromagnetic radiation means producing one or more wavelengths of electromagnetic energy suitable for determining fluid media concentration in the patient.

16. A system as defined in

claim 15

wherein the sensor employs x-ray electromagnetic energy.

18. A system as defined in

claim 14

wherein the feedback signal is a visual display of an internal view of the patient which indicates the concentration of a fluid within the patient.

19. A system as defined in

claim 18

wherein the visual display is a real time video image of the internal view of the patient.

20. A system as defined in

claim 14

wherein at least one sensor provides a feedback signal representative of a pressure of the fluid medium.

21. A system as defined in

claim 20

wherein the sensor measures an internal vessel pressure of a blood vessel within the patient.

22. The system as defined in

claim 20

wherein the sensor produces tactile feedback via a hand syringe in fluid communication with a path of the fluid medium.

17. A system as defined in

claim 17

wherein the sensor employs infrared electromagnetic energy.

23. A system for injecting a patient with a fluid medium in a medical procedure, the combination comprising:

(a) a source of a fluid medium at a selected concentration;

(b) pressurizing means in operative association with the fluid medium to pressurize the fluid medium for patient infusion; and

(c) electronic control means operably connected to said pressurizing means capable of calculating an initial flow rate for a patient based on characteristic data of the patient.

24. A system as defined in

claim 23

wherein the electronic control means is also capable of automatically adjusting the pressure of the fluid medium during patient infusion to achieve a desired flow rate.

25. A system as defined in

claim 24

wherein at least one sensor provides a feedback signal representative of a concentration of the fluid medium in the patient.

26. A system as defined in

claim 25

wherein the sensor includes electromagnetic radiation means producing one or more wavelengths of electromagnetic energy suitable for determining fluid media concentration in the patient.

27. A system as defined in

claim 26

wherein the sensor employs x-ray electromagnetic energy.

28. A system as defined in

claim 26

wherein the sensor employs infrared electromagnetic energy.

29. A system as defined in

claim 25

wherein the feedback signal is a visual display of an internal view of the patient which indicates the concentration of a fluid within the patient.

30. A system as defined in

claim 29

wherein the visual display is a real time video image of the internal view of the patient.

31. A system as defined in

claim 23

wherein at least one sensor provides a feedback signal representative of a pressure of the fluid medium.

32. A system as defined in

claim 31

wherein the sensor measures internal vessel pressure of a blood vessel in a patient.

33. A system for injection of a patient with a fluid medium in a medical procedure, the combination comprising:

(a) a source of a fluid medium including a source of contrast medium, a source of diluent, and a mixing means;

(b) pressurizing means in operative association with the fluid medium to pressurize the fluid medium for patient infusion; and

(c) electronic control means capable of calculating an initial flow rate and concentration of fluid medium based on data characteristic of the patient.

34. A system as defined in

claim 33

wherein the electronic control means is operably connected to the pressurizing means and mixing means and is capable of automatically adjusting the pressurizing means to alter the pressure of the fluid medium during patient infusion to achieve a desired flow rate and is also capable of automatically adjusting the mixing means to alter the concentration of the fluid medium during patient infusion.

35. A system as defined in

claim 34

wherein at least one sensor provides a feedback signal representative of a concentration of the fluid medium in the patient.

36. A system as defined in

claim 35

wherein the sensor includes electromagnetic radiation means producing one or more wavelengths of electromagnetic energy suitable for determining fluid media concentration in the patient.

37. A system as defined in

claim 36

wherein the sensor employs x-ray electromagnetic energy.

38. A system as defined in

claim 36

wherein the sensor employs infrared electromagnetic energy.

39. A system as defined in

claim 35

wherein the feedback signal is a visual display of an internal view of the patient which indicates the concentration of a fluid within the patient.

40. A system as defined in

claim 39

wherein the visual display is a real time video image of the internal view of the patient.

41. A system as defined in

claim 34

wherein at least one sensor provides a feedback signal representative of a pressure of the fluid medium.

42. A system as defined in

claim 41

wherein the sensor measures an internal vessel pressure of a blood vessel in the patient.

43. In a process for delivering fluid medium to at least one patient, the steps comprising:

a) providing a source of a fluid medium at a selected concentration;

b) providing an adjustable pressurizing mechanism for pressurizing the fluid medium; and

c) providing an electronic control system that is capable of regulating the pressurizing mechanism to adjust the pressure of the fluid medium for patient infusion.

44. In a process for delivering fluid medium to at least one patient, the steps comprising:

a) providing a source of a fluid medium at a selected concentration;

b) providing an adjustable pressurizing mechanism for pressurizing the fluid medium;

c) providing an electronic control system that is capable of regulating the pressurizing mechanism to adjust the flow rate of the fluid medium for patient infusion; and

d) adjusting the flow rate of the fluid medium during patient infusion.

45. In a process for delivering fluid medium to at least one patient, the steps comprising:

a) providing a source of a fluid medium at a selected concentration;

b) providing a source of a diluent and an adjustable mixing mechanism for mixing the fluid medium and diluent to adjust the concentration of the fluid medium;

c) providing an adjustable pressurizing mechanism for pressurizing the fluid medium; and

d) providing an electronic control system that is capable of regulating the flow rate via the pressurizing mechanism and which is also capable of adjusting the mixing mechanism.

46. In a process for delivering fluid medium to at least one patient, the steps comprising:

a) providing a source of a fluid medium at a selected concentration;

b) providing a source of a diluent and an adjustable mixing mechanism for mixing the fluid medium and diluent to adjust the concentration of the fluid medium;

c) providing an adjustable pressurizing mechanism for pressurizing the fluid medium;

d) providing an electronic control system that is capable of regulating the pressurizing mechanism and which is also capable of adjusting the mixing mechanism; and

e) adjusting the concentration and pressure of the fluid medium during patient infusion.

47. In a process for delivering fluid medium to at least one patient, the steps comprising:

a) providing a source of a fluid medium at a selected concentration;

b) providing a source of a diluent and an adjustable mixing mechanism for mixing the fluid medium and diluent to adjust the concentration of the fluid medium;

c) providing an adjustable pressurizing mechanism for pressurizing the fluid medium;

d) providing an electronic control system that is capable of automatically regulating the pressurizing mechanism and which is also capable of adjusting the mixing mechanism based on feedback received from at least one sensor; and

e) providing a sensor which is operably connected to the electronic control system for providing feedback.

48. A fluid medium injection controller comprising:

a syringe in fluid communication with a path of the fluid medium from a source to a patient;

the syringe having a plunger for mechanically forcing fluid from the syringe into the path of the fluid medium; and

a sensor attached to the plunger designed to sense a position of the plunger within the syringe and provide a signal representing the position.

49. The fluid medium injection controller of

claim 48

, wherein the sensor includes a linear potentiometer for sensing the position of the plunger.

50. The fluid medium injection controller of

claim 48

, wherein the sensor includes an electronic counter for sensing the position of the plunger.

51. A fluid medium injection controller comprising:

a piston and a plunger;

an electromechanical transducer located between the plunger and the piston;

an electric motor having a base at one end and a threaded drive shaft attached to the other end, the base of the motor being attached to the transducer; and

wherein the threaded drive shaft of the motor operably engages a threaded fitting on the plunger.

52. The fluid medium injection controller of

claim 51

, wherein the plunger is located within the piston.

53. The fluid medium injection controller of

claim 51

, wherein the transducer generates an electrical signal proportional to a force on the plunger.

54. The fluid medium injection controller of

claim 51

, wherein a force supplied by the electric motor is proportional to a pressure generated by a fluid medium injector.

55. A method of controlling a fluid medium injector comprising the steps of:

applying a first force to an electromechanical transducing device;

generating a first signal representing the first force applied to the electro-mechanical transducing device;

applying the first signal to a fluid medium injector and adjusting the output of the fluid medium injector with the first signal;

generating a second signal representing a pressure of the fluid medium injector;

applying the second signal to the electromagnetic transducer; and

generating a second force in substantially the opposite direction of the first force based on the strength of the second signal.

56. Automated apparatus for connecting fluid paths of selected ones of a plurality of devices to a patient, comprising:

a disposable fluid conduit communicating with the patient and the fluid paths of respective ones of said devices;

a plurality of actuators operable to communicate selected ones of said devices to the patient; and

a controller coupled to said reusable actuators with a control signal path, said controller operable to control said reusable actuators, thereby communicating selected ones of said devices to said patient.

57. The apparatus of

claim 56

, and further comprising a control actuable by an operator and remote from said controller, said controller operating said reusable actuators responsive to signals from said control.

58. The apparatus of

claim 57

, wherein said controller is actuable by the voice of an operator to control said reusable actuators.

59. The apparatus of

claim 56

, wherein said reusable actuators are mounted in a reusable unit, said unit having first alignment means, said reusable conduit having second alignment means, said first and second alignment means matable in order to mate said reusable unit to said disposable conduit.

61. The apparatus of

claim 56

, and further comprising a plurality of valves mounted on said conduit, each of said reusable actuators cooperating with a respective valve, each of said valves adaptable to be coupled to a fluid path of a respective device and actuable to selectively communicate said fluid path with said conduit.

62. The apparatus of

claim 61

, wherein said valves are quarter-turn rotating valves.

63. The apparatus of

claim 61

, wherein said reusable actuators are rotating solenoids.

60. The apparatus of

claim 60

, wherein said reusable unit includes a face, said first alignment means including a plurality of pins upstanding from said face, a body of said conduit including holes for receiving said pins.