Multiparameter whole blood monitor and method

• US 20060287600A1
• Filed: 09/09/2005
• Published: 12/21/2006
• Est. Priority Date: 09/18/2003
• Status: Active Grant

• Current Assignee: New Paradigm Concepts LLC
• Original Assignee: New Paradigm Concepts LLC
• Inventors: McEowen, Edwin L.
• Granted Patent: US 7,559,894 B2
• Time in Patent Office: Days
• US Class Current: 600/481
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0257 using atmospheric pressure
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02116 of pulse wave amplitude A61B5/02225 takes precedence
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6817 Ear canal
• 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 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

The present invention provides an apparatus and methods for continuous intravascular measurement of whole blood concentration, blood pressure, and pulse pressure. The intravascular catheter incorporates a sensor to measure whole blood sound velocity, attenuation, backscatter amplitude, and blood flow velocity and also incorporates existing technologies for multiple physiologic measurements of whole blood. Pulse wave velocity and wave intensity are derived mathematically for purposes of estimating degree of local vascular tone.

Claims

1. A blood monitoring device comprising a body having a proximal and distal transducers spaced apart and connected to both device drivers and recognition and analysis devices, a power source connected to both said device drivers and said recognition and analysis devices, said device driver also connected to said recognition and analysis devices.

2. The device of claim 1 wherein the transducers are tuned to a point within a human being'"'"'s blood.

3. The device of claim 2 wherein said transducers are tuned to ambient atmospheric pressure and temperature.

4. The device of claim 1 wherein both proximal and distal transducers include a plurality of transducers.

5. The device of claim 1 wherein said plurality of transducers are tuned to different frequencies.

6. The device of claim 1 wherein said proximal and distal transducers are both senders and receivers.

7. The device of claim 1 wherein said transducers may be chosen from the group of transducers consisting of Piezoceramic transducers, import impulse click transducers, polymer Piezo transducers, laser transducers, infrared transducers, radio frequency transducers, Fiber-Bragg laser receivers, hybrid transducers and combinations thereof.

8. The device of claim 1 wherein said device drivers are chosen from the group of device drivers consisting of impulse generators, wave generators, and electronic switches.

9. The device of claim 1 wherein said recognition and analysis devices is chosen from the group of recognition and analysis devices consisting of scanners, displays, computers, printers, recorders, senders, receivers, and combinations thereof.

10. The device of claim 1 wherein proximal and distal transducers may be adjusted as to operational frequency.

11. The device of claim 1 wherein said proximal and distal transducers have frequencies ranging from about 500 KHz to about 100 MHz.

12. The device of claim 1 wherein said recognition and analysis devices measures ultrasound time of flight, arterial blood density, venous blood density, hemoglobin and hematocrit (H/H), blood flow velocity, pulse rate, venous and arterial flow velocity, blood pressure analogs, analogs of vascular resistance, analogs of cardiac output, analogs of blood volume, signal to noise ratio, and combinations thereof.

13. The device of claim 1 wherein said device may be adjusted for ambient temperature and varying distances between said distal and proximal transducers.

14. The device of claim 1 wherein said proximal and distal transducers are on opposite sides of a blood vessel.

15. The device of claim 14 wherein said blood vessel is a vein.

16. The device of claim 14 wherein said blood vessel is an artery.

17. The device of claim 14 wherein the path over which the sound waves travel between the proximal and distal transducers is generally perpendicular to said blood vessel.

18. The device of claim 14 wherein the path over which the sound waves travel between the proximal and distal transducers is generally longitudinal with said blood vessel.

19. The device of claim 1 wherein the frequency of the transducers is between 5 and 10 Mhz.

20. The device of claim 14 wherein said proximal and distal transducers are on opposite sides of the perioral arteries.

21. The device of claim 1 wherein said proximal and distal transducers are on opposite sides of the pre and post auricular arteries.

22. The device of claim 1 further comprising an oximeter.

23. The device of claim 1 wherein said recognition and analysis devices emit a continuous record of data relating to the measurements of the group of measurements consisting of blood density, H/H, temperature, arterial and venous blood pressure, pulse rate, blood flow velocity, and pulse pressure analog, or combinations thereof.

81. The apparatus of claims 1 or 24 or 48 wherein blood volume is calculated from the change in sound speed after an injection of IV fluid.

82. The apparatus of claim 1 or 24 or 48 wherein cardiac output is calculated from the rate of change in sound speed after an injection of IV fluid.

24. The blood monitoring device comprising an intravascular catheter having proximal and distal transducer device therein spaced apart and connected to both drivers and recognition and analysis devices, said transducer devices facing each other with a space therebetween which fills with blood when said catheter is inserted into a vein or artery, said transducer devices including means for measuring sound, speed and blood flow, a power source connected to both said drivers and said recognition and analysis devices, said drivers also being connected to said recognition and analysis devices.

25. The blood monitoring device of claim 24 further comprising a temperature sensor, said temperature sensor measuring the temperature of said blood in said space.

26. The blood monitoring device of claim 24 further comprising a pressure sensor, said pressure sensor measuring a pressure of said blood in said space.

27. The blood monitoring device of claim 24 further comprising a concentration sensor, said sensor measuring concentrations of said blood arterial oxygen and arterial carbon dioxide and pH of said blood in said space.

28. The blood monitoring device of claim 24 further comprising a pulse rate and respiratory rate sensor.

29. The blood monitoring device of claim 24 further comprising an oximeter.

30. The device of claim 24 wherein the transducer devices are tuned to a point within a human being'"'"'s blood.

31. The device of claim 24 wherein said transducer devices are tuned to ambient atmospheric pressure and temperature.

32. The device of claim 24 wherein both proximal and distal transducer devices include a plurality of transducers.

33. The device of claim 32 wherein said plurality of transducer devices are tuned to different frequencies.

34. The device of claim 24 wherein said proximal and distal transducer devices are both senders and receivers.

35. The device of claim 24 wherein said transducer devices may be chosen from the group of transducers consisting of Piezoceramic transducers, import impulse click transducers, polymer Piezo transducers, laser transducers, infrared transducers, radio frequency transducers, Fiber-Bragg laser receivers, hybrid transducers and combinations thereof.

36. The device of claim 24 wherein said drivers are chosen from the group of device drivers consisting of impulse generators, wave generators, and electronic switches.

37. The device of claim 24 wherein said recognition and analysis devices is chosen from the group of recognition and analysis devices consisting of scanners, displays, computers, printers, recorders, senders, receivers, and combinations thereof.

38. The device of claim 24 wherein said proximal and distal transducer devices may be adjusted as to operational frequency.

39. The device of claim 38 wherein said proximal and distal transducer devices have frequencies ranging from about 500 KHz to about 100 MHz

40. The device of claim 24 wherein said recognition and analysis devices measures ultrasound time of flight, arterial blood density, venous blood density, H/H, blood flow velocity (venous and arterial), analogs of vascular resistance, analogs of cardiac output, signal to noise ratio, and combinations thereof.

41. The device of claim 24 wherein said drivers may be adjusted for ambient temperature and varying distances between said distal and proximal transducer device.

42. The device of claim 24 wherein the frequency of the transducer devices is between 5 and 20 Mhz.

43. The device of claim 24 wherein said recognition and analysis devices emit a continuous record of data relating to the measurements of the group of measurements consisting of arterial and venous blood density, H/H, temperature, arterial and venous blood pressure, pulse rate, blood flow velocity, pulse pressure analogs, analogs of vascular resistance, analogs of cardiac output, analogs of blood volume, or combinations thereof.

44. The device of claim 24 further comprising a display which displays both instantaneous measurements and a plot of each measurement versus time.

45. The device of claim 24 wherein one of said transducer devices is both a sender and a receiver and the other of said transducer devices is a reflector.

46. The device of claim 24 wherein said transducers are spaced apart by a plurality of struts, said struts being smaller in transverse size than said catheter, said struts defining a space between said transducers which fills with blood when said catheter is inserted into a vein or artery.

47. The device of claim 24 wherein said space is enclosed beneath a membrane, said space being filled with gas.

48. An apparatus for continuously monitoring blood in the human body comprising of a pair of spaced sensors with blood therebetween, said sensors being connected to both device drivers and recognition and analysis devices, a power source connected to both said device drivers and said recognition analysis devices, said device driver also connected to said recognition analysis devices whereby blood properties can be continuously monitored and compared to normal blood property ranges to suggest care for ill and injured patients.

49. The apparatus of claim 48 wherein said sensors are on opposite sides of a blood vessel in which blood flows perpendicular to the distance between said sensors.

50. The apparatus of claim 48 wherein said sensors are positioned within a blood vessel in which blood flows longitudinally between said sensors.

51. The apparatus of claim 48 wherein the sensors are tuned to a point within a human being'"'"'s blood.

52. The apparatus of claim 51 wherein said sensors are tuned to ambient atmospheric pressure and temperature.

53. The apparatus of claim 48 wherein both proximal and distal sensors include a plurality of sensors.

54. The apparatus of claim 48 wherein said plurality of sensors are tuned to different frequencies.

55. The apparatus of claim 48 wherein said proximal and distal sensors are both senders and receivers.

56. The apparatus of claim 48 wherein said sensors may be chosen from the group of sensors consisting of Piezoceramic transducers, import impulse click transducers, polymer Piezo transducers, laser transducers, infrared transducers, radio frequency transducers, Fiber-Bragg laser receivers, hybrid transducers and combinations thereof.

57. The apparatus of claim 48 wherein said device drivers are chosen from the group of device drivers consisting of impulse generators, wave generators, and electronic switches.

58. The apparatus of claim 48 wherein said recognition and analysis devices is chosen from the group of recognition and analysis devices consisting of scanners, displays, computers, printers, recorders, senders, receivers, and combinations thereof.

59. The apparatus of claim 48 wherein proximal and distal transducers may be adjusted as to operational frequency.

60. The apparatus of claim 48 wherein said proximal and distal transducers have frequencies ranging from about 500 KHz to about 100 MHz.

61. The apparatus of claim 48 wherein said recognition and analysis devices measures ultrasound time of flight, arterial blood density, venous blood density, hemoglobin and hematocrit (H/H), blood flow velocity, pulse rate, venous and arterial flow velocity, blood pressure analogs, analogs of vascular resistance, analogs of cardiac output, analogs of blood volume, signal to noise ratio, and combinations thereof.

62. The apparatus of claim 48 wherein said device may be adjusted for ambient temperature and varying distances between said distal and proximal sensors.

63. The apparatus of claim 48 wherein said proximal and distal sensors are on opposite sides of a blood vessel.

64. The apparatus of claim 63 wherein said blood vessel is a vein.

65. The apparatus of claim 63 wherein said blood vessel is an artery.

66. The apparatus of claim 48 wherein the frequency of the sensors is between 5 and 10 Mhz.

67. The apparatus of claim 48 wherein said recognition and analysis devices emit a continuous record of data relating to the measurements of the group of measurements consisting of blood density, H/H, temperature, arterial and venous blood pressure, pulse rate, blood flow velocity, analogs of vascular resistance, analogs of cardiac output, analogs of blood volume, pulse pressure analogs, or combinations thereof.

68. The apparatus of claim 48 further comprising a temperature sensor, said temperature sensor measuring the temperature of said blood in said space.

69. The apparatus of claim 48 further comprising a pressure sensor, said pressure sensor measuring a pressure of said blood in said space.

70. The apparatus of claim 48 further comprising a concentration sensor, said sensor measuring concentrations of said blood arterial oxygen and arterial carbon dioxide and pH of said blood in said space.

71. The apparatus of claim 48 further comprising a pulse rate and respiratory rate sensor.

72. The apparatus of claim 48 further comprising an oximeter.

73. The method comprising continuously measuring the properties of flowing blood through a blood vessel in a human body, comparing said properties with normal ranges of said properties to suggest care for ill and injured patients.

74. The method comprising measuring the sound transmission speed in whole blood, and continuously monitoring blood properties.

79. The method of claim 74 wherein blood volume is calculated from the change in sound speed after an injection of IV fluid.

80. The method of claim 74 wherein cardiac output is calculated from the rate of change in sound speed after an injection of IV fluid.

75. The method comprising measuring whole blood sound speed continuously, displaying said whole blood sound speed, and converting said whole blood sound speed to continuous measurements of blood properties.

76. The method of claim 75 wherein said blood properties include the group of blood properties consisting of blood density, H/H, blood pressure, blood volume, pulse rate, systolic blood pressure, diastolic blood pressure, temperature, LVR, cardiac output, blood volume, analogs of vascular resistance, and combinations thereof.

77. The method of claim 75 wherein attenuation is utilized to correct said blood properties.

78. The method of claim 75 wherein backscatter measurements are utilized to correct said blood properties.