Patient specific dosing contrast delivery systems and methods

• US 5,840,026 A
• Filed: 09/21/1994
• Issued: 11/24/1998
• Est. Priority Date: 09/21/1994
• Status: Expired due to Term

• 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.
• Primary Examiner(s): CASLER, BRIAN L
• Application Number:
  US08/309,820
• Time in Patent Office: 1,525 Days
• Field of Search: 128/654, 128/655, 128/DIG. 12, 128/DIG. 13, 604/65-67, 604/246, 604/247, 604/131, 604/151, 600/3, 600/431, 600/432
• 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.

Claims

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

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

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

(c) electronic control means for calculating flow rate and concentration of the fluid medium based on characteristic data of the patient, said electronic control means being connected to said pressurizing means for setting initial fluid medium pressure based on said characteristic data of the patient, and for adjusting concentration of the fluid medium during injection based on said characteristic data of the patient;

(d) imaging means for recording the image contrast fluid medium injected into the patient.

2. The system as defined in claim 1, wherein the electronic control means further adjusts 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 at least one wavelength of electromagnetic energy for determining fluid media concentration in the patient.

5. The system as defined in claim 4 wherein the electromagnetic energy comprises x-ray electromagnetic energy.

6. The system as defined in claim 4 wherein the electromagnetic energy comprises 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 further comprising at least one sensor for providing a feedback signal representative of a parameter of the injection in the patient, said parameter being selected from the group consisting of pressure, volume delivered and flow rate.

10. The system as defined in claim 9 wherein the sensor comprises means for measuring internal vessel pressure of a blood vessel in a patient.

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

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

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

(c) electronic control means connected to said pressurizing means for setting initial fluid medium pressure or flow rate,

(d) at least one sensor for providing a feedback signal representative of a parameter of the injection in the patient, said parameter being selected from the group consisting of pressure, volume delivered and flow rate, and

(e) tactile feedback means for communicating a signal to an operator for adjusting said parameter during patient infusion.

12. A system according to claim 11, wherein the tactile feedback means comprises a fluid medium injection controller, comprising:

a syringe in fluid communication with a path of the fluid medium from the source to the 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 for sensing a position of the plunger within the syringe and for providing a signal representing the position.

13. The fluid medium injection controller of claim 12, wherein the sensor includes a linear potentiometer for sensing the position of the plunger.

14. The fluid medium injection controller of claim 12, wherein the sensor includes an electronic counter for sensing the position of the plunger.

15. A system according to claim 11, wherein the tactile feedback means comprises a fluid medium injection controller, comprising:

a plunger and an outside case;

an electromechanical transducer measuring force exerted between the plunger and the outside case; and

an electric motor having a base at a first end and a threaded drive shaft attached to a second end;

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

16. The fluid medium injection controller of claim 15, wherein the electromechanical transducer is located between the motor and the case.

17. The fluid medium injection controller of claim 15, wherein the transducer generates an electrical signal proportional to the force between the plunger and the case.

18. The fluid medium injection controller of claim 15, wherein a force supplied by the electric motor is proportional to a pressure generated by a fluid medium injector.

19. A system according to claim 11, wherein the tactile feedback means comprises:

means for applying a first force to an electro-mechanical transducing device;

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

means for generating a second signal representing said parameter of the injection;

means for applying the second signal to the electromagnetic transducer; and

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

20. A system according to claim 11, further comprising means for imaging.

21. A system according to claim 20, wherein the tactile feedback means comprises 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.

22. A system of claim 21, wherein the sensor includes a linear potentiometer for sensing the position of the plunger.

23. A system of claim 21, wherein the sensor includes an electronic counter for sensing the position of the plunger.

24. A system according to claim 20, wherein the tactile feedback means comprises a fluid medium injection controller comprising:

a plunger and an outside case;

an electro-mechanical transducer measuring force exerted between the plunger and the outside case; and

an electric motor having a base at a first end and a threaded drive shaft attached to a second end;

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

25. A system of claim 24, wherein the electromechanical transducer is located between the motor and the case.

26. A system controller of claim 24, wherein the transducer generates an electrical signal relational to the force between the plunger and the case.

27. A system controller of claim 24, wherein a force supplied by the electric motor is relational to a pressure generated by a fluid medium injector.

28. A system according to claim 20, wherein the tactile feedback means comprises:

means for applying a first force to an electro-mechanical transducing device;

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

means for generating a second signal representing said parameter of the injection;

means for applying the second signal to the electromagnetic transducer; and

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

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

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

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

(c) electronic control means for calculating an initial flow rate and concentration of fluid medium based on characteristic data of the patient, wherein the electronic control means is connected to the pressurizing means and mixing means and comprises means for adjusting the mixing means to alter concentration of the fluid medium during patient infusion.

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

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

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

(c) electronic control means for calculating an initial flow rate and concentration of the fluid medium based on characteristic data of the patient, wherein the electronic control means communicates with the pressurizing means and with the mixing means and comprises means for adjusting the mixing means to alter concentration of the fluid medium during patient infusion;

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

31. A system as defined in claim 30, wherein the sensor includes electromagnetic radiation means for producing at least one wavelength of electromagnetic energy for use for determining fluid media concentration in the patient.

32. A system as defined in claim 31 wherein the electromagnetic energy comprises x-ray electromagnetic energy.

33. A system as defined in claim 31 wherein the electromagnetic energy comprises infrared electromagnetic energy.

34. A system as defined in claim 30 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.

35. A system as defined in claim 34 wherein the visual display is a real time video image of the internal view of the patient.

36. The system as defined in claim 30, further comprising at least one sensor for providing a feedback signal representative of a pressure of the fluid medium.

37. A system as defined in claim 36 wherein the sensor comprises means for measuring an internal vessel pressure of a blood vessel within the patient.

38. The system for injection of a patient with a fluid medium in a medical procedure, comprising:

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

(b) pressurizing means connected with the fluid medium for pressurizing the fluid medium for patient infusion;

(c) electronic control means for calculating an initial flow rate and concentration of fluid medium based on characteristic data of the patient, wherein the electronic control means is connected to the pressurizing means and the mixing means and comprises means for adjusting at least one of the mixing means and the pressurizing means to alter concentration of the fluid medium during patient infusion;

(d) at least one sensor for providing a feedback signal representative of the concentration of the fluid medium in the patient;

(e) at least one sensor for providing a feedback signal representative of the pressure of the fluid medium; and

(f) tactile feedback means for communicating a signal to an operator for adjusting at least one of said concentration and said pressure during patient infusion.

39. A system according to claim 38 wherein the tactile feedback means comprises 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.

40. The fluid medium injection controller of claim 39, wherein the sensor includes a linear potentiometer for sensing the position of the plunger.

41. The fluid medium injection controller of claim 39, wherein the sensor includes an electronic counter for sensing the position of the plunger.

42. A fluid medium injection controller according to claim 38 comprising:

a plunger and an outside case;

an electromechanical transducer measuring force exerted between the plunger and the outside case; and

an electric motor having a base at a first end and a threaded drive shaft attached to a second end;

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

43. The fluid medium injection controller of claim 42, wherein the electromechanical transducer is located between the motor and the case.

44. The fluid medium injection controller of claim 42, wherein the transducer generates an electrical signal proportional to the force between the plunger and the case.

45. The fluid medium injection controller of claim 42, wherein a force supplied by the electric motor is proportional to a pressure generated by a fluid medium injector.

46. A system according to claim 38, wherein the tactile feedback means comprises:

means for applying a first force to an electro-mechanical transducing device;

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

means for generating a second signal representing said parameter of the injection;

means for applying the second signal to the electromagnetic transducer; and

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

47. 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 for, calculating an initial flow rate and concentration of fluid medium based on data characteristic of the patient,

said electronic control means being connected to the pressurizing means, and

said electronic control means comprising at least one of means for adjusting the pressurizing means to alter the pressure of the fluid medium during patient infusion to achieve a desired flow rate and means for adjusting the mixing means to alter the concentration of the fluid medium during patient infusion.

48. A system as defined in claim 47 wherein at least one sensor provides a feedback signal representative of a concentration of the fluid medium in the patient.

49. A system as defined in claim 48 wherein the sensor includes electromagnetic radiation means producing one or more wavelengths of electromagnetic energy suitable for determining fluid media concentration in the patient.

50. A system as defined in claim 49 wherein the sensor employs x-ray electromagnetic energy.

51. A system as defined in claim 49 wherein the sensor employs infrared electromagnetic energy.

52. A system as defined in claim 48 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.

53. A system as defined in claim 52 wherein the visual display is a real time video image of the internal view of the patient.

54. A system as defined in claim 47 wherein at least one sensor provides a feedback signal representative of a pressure of the fluid medium.

55. A system as defined in claim 54 wherein the sensor measures an internal vessel pressure of a blood vessel in the patient.

56. 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;

c) calculating an initial flow rate and concentration of the fluid medium based on characteristic data of the patient using electronic control means, wherein the electronic control means communicates with adjustable pressurizing means and adjustable mixing means; and

d) adjusting the mixing means to alter concentration of the fluid medium during patient infusion according to said characteristic data of the patient.

57. 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;

c) calculating an initial flow rate and concentration of the fluid medium based on characteristic data of the patient using electronic control means, wherein the electronic control means communicates with adjustable pressurizing means and adjustable mixing means; and

d) adjusting the mixing means to alter concentration of the fluid medium during patient infusion according to said characteristic data of the patient;

e) sensing feedback of said data characteristic of the patient with a sensor which is operably connected to the electronic control system.

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

(a) pressurizing means communicating with the fluid medium to pressurize the fluid medium for patient infusion; and

(b) electronic control means for calculating an initial flow rate and concentration of the fluid medium based on characteristic data of the patient, wherein the electronic control means communicates with the pressurizing means and with mixing means and comprises means for adjusting the mixing means to alter the concentration of the fluid medium during patient infusion.

59. A system according to claim 58, further comprising:

imaging means for recording the image contrast fluid medium injected into the patient.

60. A system according to claim 58, further comprising:

a sensor operably connected to the electronic control system for providing feedback of said data characteristic of the patient.