Apparatus and method for non-invasive and minimally-invasive sensing of parameters relating to blood

• US 20070093702A1
• Filed: 10/26/2005
• Published: 04/26/2007
• Est. Priority Date: 10/26/2005
• Status: Abandoned Application

• Current Assignee: Skyline Medical Inc.
• Original Assignee: Skyline Medical Inc.
• Inventors: Kim, Daniel, Yu, Zengpin, Cheng, Xuefeng, Khuri-Yakub, Butrus
• Application Number:
  US11/259,858
• Publication Number:
  US 20070093702A1
• Time in Patent Office: Days
• US Class Current: 600/326
• CPC Class Codes: A61B 5/0051 by applying vibrations
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

A system and method for monitoring one or more parameters relating to blood, such as cardiac output, of a patient is provided. The system preferably includes an acoustic energy transducer unit configured and positioned to transmit acoustic energy into a target structure, preferably a blood vessel, within the patient so as to induce a measurable change, preferably a change in blood volume, within the target structure. The transducer unit can be an ultrasonic array, annular array, or groups thereof, or a single element transducer. The unit can also be a vibrator or acoustic loudspeaker. An optical transmitter transmits light into the target structure, and an optical receiver senses light scattered from within the target structure. The blood parameter can then be estimated from the sensed scattered radiation. Relative blood oxygen saturation in the blood vessel, can be estimated by transmitting two wavelengths to measure oxy-hemoglobin and deoxy-hemoglobin.

Claims

1. A system for monitoring one or more parameters relating to blood of a patient comprising:

an acoustic energy transducer unit configured and positioned to transmit acoustic energy into a target structure within the patient so as to induce a measurable change within the target structure;

at least one optical transmitter configured to generate electromagnetic radiation containing photons having a specific interaction with at least one target chromophore in the target structure, the transmitter configured and positioned to transmit the radiation into the target structure;

at least one optical receiver configured and positioned to detect a portion of the electromagnetic radiation scattered from within the target structure; and

a processor adapted to estimate the one or more parameters relating to the patient'"'"'s blood, the estimation based in part on the scattered radiation detected from within the target structure.

2. A system according to claim 1 wherein said estimation is also based in part on the measured induced change within the target structure.

3. A system according to claim 1 wherein said induced change is a change in blood volume in the target structure.

4. A system according to claim 1 wherein said at least one optical transmitter is configured to transmit continuous wave electromagnetic radiation into the target structure, and said at least one optical receiver is configured to detect continuous wave scattered radiation from the target structure.

5. A system according to claim 1 wherein said at least one optical transmitter is configured to transmit pulsed wave electromagnetic radiation into the target structure, and said at least one optical receiver is configured to detect pulsed wave scattered radiation from the target structure.

6. A system according to claim 1 wherein said acoustic energy transducer unit comprises at least one ultrasound transducer and is further configured to provide an ultrasound radiation pressure field into the target structure so as to modulate the target structure at a modulation frequency, and the system further comprising a filter coupled to the at least one optical detector, the filter being configured to select detected electromagnetic radiation having a modulation component at the same frequency as the modulation frequency, or at a harmonic of the modulation frequency.

7. A system according to claim 6 wherein said acoustic energy transducer unit comprises a transmit array including an array of transducer elements arranged and configured to generate the ultrasound radiation pressure field in the form of at least one ultrasonic beam.

8. A system according to claim 7 wherein said array of transducers is arranged to form a linear array.

9. A system according to claim 7 wherein said acoustic energy transducer unit comprises two or more groups of transducer elements arranged and configured to generate a plurality of ultrasonic beams focused in a target area within the target structure.

10. A system according to claim 6 wherein at least one ultrasound transducer has an approximately circular cross section.

11. A system according to claim 10 wherein the at least one ultrasound transducer is a single element transducer.

12. A system according to claim 10 wherein the at least one ultrasound transducer includes an annular array of transducers comprising concentric ring-shaped ultrasonic transducer elements.

13. A system according to claim 10 wherein at least part of said acoustic energy transducer unit is mounted in at least one adapter configured such that the position of the at least one ultrasound transducer can be moved with respect to the patient'"'"'s target structure.

14. A system according to claim 13 wherein at the at least one adapter is made at least partially of a compliant material containing an acoustic couplant.

15. A system according to claim 13 wherein the at least one adapter is configured to allow for movement of the at least one ultrasound transducer in a direction parallel to a line between the ultrasound transducer and the target structure.

16. A system according to claim 13 wherein the at least one adapter is configured to allow for a tilting movement of the at least one ultrasound transducer so as to direct the ultrasound pressure field towards the target structure.

17. A system according to claim 6 wherein the ultrasound radiation pressure field induces changes in the shape of the target structure which induces a change in the blood flow in the target structure.

18. A system according to claim 1 wherein the acoustic energy transducer unit comprises a vibrator adapted and positioned to transmit vibrational energy into the target structure thereby inducing a change in blood flow in the target structure.

19. A system according to claim 18 wherein the blood flow in the target structure is modulated by the vibrational energy so as to modulate at a modulation frequency, and the system further comprises a filter coupled to the at least one optical detectors, the filter being configured to select detected electromagnetic radiation having a modulation component at the same frequency as the modulation frequency, or at a harmonic of the modulation frequency.

20. A system according to claim 1 wherein the acoustic energy transducer unit comprises an acoustic loudspeaker adapted and positioned to transmit acoustic energy into the target structure thereby inducing a change in blood flow in the target structure.

21. A system according to claim 20 wherein the blood flow in the target structure is modulated by the acoustic energy so as to modulate at a modulation frequency, and the system further comprises a filter coupled to the at least one optical detectors, the filter being configured to select detected electromagnetic radiation having a modulation component at the same frequency as the modulation frequency, or at a harmonic of the modulation frequency.

22. A system according to claim 6 wherein the at least one ultrasound transducer is adapted to generate an image of tissues including the target structure to enable placement of the at least one optical transmitter and at least one optical receiver on the patient so as to enhance the accuracy of the monitoring of the system.

23. A system according to claim 1 wherein the at least one optical transmitter is configured and positioned to transmit the radiation into a second area not including a substantial portion of the target structure, the at least one optical receivers is configured and positioned to receive radiation scattered from the second area, and the processor further adapted to estimate absorption properties associated with the second area from the radiation scattered from the second area, and wherein the estimation of the one or more parameters relating to the patient'"'"'s blood is based in part on the estimated absorption properties.

24. A system according to claim 23 wherein the at least one transmitter and the at least one receiver further comprise a first transmitter-receiver pair for transmitting radiation into and detecting radiation scattered from the target area, and a second transmitter-receiver pair for transmitting radiation into and detecting radiation scattered from the second area, and wherein the first transmitter-receiver pair comprises a transmitter and receiver spaced apart about 3 cm to about 7 cm, and the second transmitter-receiver pair comprises a transmitter and receiver spaced apart about 0.5 cm to about 3 cm.

25. A system according to claim 1 wherein the processor is adapted to calculate a calibration adjustment based on measurements performed by the at least one optical receiver both with and without the use of the acoustic energy transducer unit.

26. A system according to claim 1 wherein the target structure is a blood vessel.

27. A system according to claim 26 wherein said processor is further adapted to calculate relative blood oxygen saturation in the blood vessel.

28. A system according to claim 1 wherein the radiation comprises photons having a first wavelength and photons having a second wavelength, the first wavelength selected to have the specific interaction with a first target chromophore, and the second wavelength selected to have a specific interaction with a second target chromophore.

29. A system according to claim 28 wherein the first target chromophore is oxy-hemoglobin and the second target chromophore is deoxy-hemoglobin.

30. A system according to claim 29 wherein the target structure is a blood vessel, and the one or more of the parameters relating to blood includes oxygen saturation of blood in the blood vessel.

31. A system according to claim 30 wherein the blood vessel is a major vein.

32. A system according to claim 31 wherein the major vein is the internal jugular vein.

33. A system according to claim 30 wherein the blood vessel is a major artery.

34. A system according to claim 1 wherein the one or more of the parameters relating to blood oxygenation includes the patient'"'"'s cardiac output.

35. A system according to claim 1 wherein said acoustic energy transducer unit, said at least one transmitter and said at least one receiver are at least partially mounted on a sensor patch designed to be engaged to the patient'"'"'s skin.

36. A system according to claim 1 wherein said processor comprises a general purpose computer, and said system further comprising a system box in which at least a portion of said acoustic energy transducer unit, said at least one optical transmitter, said at least one optical receiver, and said processor are housed, and wherein said station box is in communication with a display adapted to display the one or more parameters relating to blood to a human operator.

37. A system according to claim 1 wherein the one or more parameters relating to blood is blood pH level, one of the at least one target chromophores is met-hemoglobin.

38. A system according to claim 1 wherein the one or more parameters relating to blood relates to water or lipid concentrations in the blood.

39. A system according to claim 1 wherein the target structure is selected from a set consisting of exterior jugular vein, subclavian vein, superior vena cava and pulmonary artery.

40. A system according to claim 1 wherein the patient is a neonatal patient.

41. A system according to claim 1 wherein the patient is a fetus.

42. A system according to claim 1 wherein the target structure is located about 2 cm from the skin of the patient.

43. A method for monitoring one or more parameters relating to blood of a patient comprising the steps of:

inducing a change in blood volume in a target structure within the patient;

transmitting two or more frequencies of electromagnetic radiation into the target structure;

sensing the two or more frequencies of electromagnetic radiation having scattered from within the target structure; and

calculating the one or more parameters relating to blood based at least in part on the sensed electromagnetic radiation.

44. A method according to claim 43 wherein said step of sensing includes sensing the induced change in blood volume, and wherein said step of calculating is based in part on the sensed induced change.

45. A method according to claim 43 wherein the transmitted electromagnetic radiation is continuous wave radiation.

46. A method according to claim 43 wherein the transmitted electromagnetic radiation is pulsed wave radiation.

47. A method according to claim 43 wherein said step of inducing comprises activating at least one acoustic energy transducer unit.

48. A method according to claim 47 wherein the acoustic energy transducer unit includes at least one ultrasound transducer that when activated provides an ultrasound radiation pressure field into the target structure so as to modulate the target structure at a modulation frequency, and the method further comprising the step of filtering the electromagnetic radiation in order to detect a modulation component at the same frequency as the modulation frequency, or at a harmonic of the modulation frequency.

49. A method according to claim 48 wherein said acoustic energy transducer unit comprises a transmit array including an array of transducer elements activated to generate at least one ultrasonic beam.

50. A method according to claim 49 wherein said array of transducers is arranged to form a linear array.

51. A method according to claim 49 wherein said step of inducing further comprises generating a plurality of ultrasonic beams focused in the target area using two or more groups of transducer elements.

52. A method according to claim 48 wherein at least one ultrasound transducer has an approximately circular cross section.

53. A method according to claim 52 wherein the at least one ultrasound transducer is a single element transducer.

54. A method according to claim 52 wherein the at least one ultrasound transducer includes an annular array of transducers comprising concentric ring-shaped ultrasonic transducer elements.

55. A method according to claim 52 wherein at least part of said acoustic energy transducer unit is mounted in at least one adapter, and said step of inducing includes moving the at least one ultrasound transducer with respect to the patient'"'"'s target structure using the at least one adapter.

56. A method according to claim 55 wherein at the at least one adapter is made at least partially of a compliant material containing an acoustic couplant.

57. A method according to claim 55 wherein the at least one adapter is configured to allow for movement of the at least one ultrasound transducer in a direction parallel to a line between the ultrasound transducer and the target structure.

58. A method according to claim 55 wherein the at least one adapter is configured to allow for a tilting movement of the at least one ultrasound transducer so as to direct the ultrasound pressure field towards the target structure.

59. A method according to claim 48 wherein the ultrasound radiation pressure field induces changes in the shape of the target structure thereby inducing a change in the blood flow in the target structure.

60. A method according to claim 47 wherein the acoustic energy transducer unit includes a vibrator, and said step of inducing further comprises transmitting vibrational energy into the target structure using the vibrator thereby inducing a change in blood flow in the target structure.

61. A method according to claim 60 wherein the blood flow in the target structure is modulated by the vibrational energy so as to modulate at a modulation frequency, and the method further comprises the step of filtering to the sensed electromagnetic radiation to detect radiation having a modulation component at the same frequency as the modulation frequency, or at a harmonic of the modulation frequency.

62. A method according to claim 47 wherein the acoustic energy transducer unit comprises an acoustic loudspeaker, and said step of inducing further comprises transmitting acoustic energy into the target structure using the acoustic loudspeaker thereby inducing a change in blood flow in the target structure.

63. A method according to claim 62 wherein the blood flow in the target structure is modulated by the acoustic energy so as to modulate at a modulation frequency, and the method further comprises the step of filtering the sensed electromagnetic radiation to detect radiation having a modulation component at the same frequency as the modulation frequency, or at a harmonic of the modulation frequency.

64. A method according to claim 48 further comprising the step of generating an image of tissues including the target structure using the at least one ultrasound transducer to enable placement of at least one optical transmitter and at least one optical receiver on the patient so as to enhance the accuracy of the monitoring of the system.

65. A method according to claim 43 further comprising the step of:

transmitting electromagnetic radiation into a second area not including a substantial portion of the target structure;

receiving electromagnetic radiation scattered from the second area, and wherein the step of calculating includes estimating absorption properties associated with the second area from the radiation scattered from the second area, and the calculation of the one or more parameters relating to the patient'"'"'s blood is based in part on the estimated absorption properties.

66. A method according to claim 65 wherein the step of transmitting two or more frequencies of electromagnetic radiation in to the target structure uses a first transmitter-receiver pair spaced apart about 3 cm to about 7 cm, staid step of transmitting electromagnetic radiation into a second area uses a second transmitter-receiver pair spaced apart about 0.5 cm to about 3 cm.

67. A method according to claim 43 wherein said step of sensing includes sensing electromagnetic radiation both with and with the induced change in blood volume, and the method further comprising the step of calculating a calibration adjustment based on the sensing performed both with and without the induced change in blood volume.

68. A method according to claim 43 wherein the target structure is a blood vessel.

69. A method according to claim 68 wherein said step of calculating includes calculating relative blood oxygen saturation in the blood vessel.

70. A method according to claim 43 wherein the electromagnetic radiation comprises photons having a first wavelength and photons having a second wavelength, the first wavelength selected to have the specific interaction with a first target chromophore within the target structure, and the second wavelength selected to have a specific interaction with a second target chromophore within the target structure.

71. A method according to claim 70 wherein the first target chromophore is oxy-hemoglobin and the second target chromophore is deoxy-hemoglobin.

72. A method according to claim 71 wherein the target structure is a blood vessel, and the one or more of the parameters relating to blood includes oxygen saturation of blood in the blood vessel.

73. A method according to claim 72 wherein the blood vessel is a major vein.

74. A method according to claim 73 wherein the major vein is the internal jugular vein.

75. A method according to claim 72 wherein the blood vessel is a major artery.

76. A method according to claim 43 wherein the one or more of the parameters relating to blood oxygenation includes the patient'"'"'s cardiac output.

77. A method according to claim 47 further comprising engaging on the patient'"'"'s skin a sensor patch on which the acoustic energy transducer unit, at least one transmitter and at least one receiver are at least partially mounted.

78. A method according to claim 43 further comprising the stop of displaying the one or more parameters relating to blood to a human operator.

79. A method according to claim 43 wherein the one or more parameters relating to blood is blood pH level, one of the at least one target chromophores is met-hemoglobin.

80. A method according to claim 43 wherein the one or more parameters relating to blood relates to water or lipid concentrations in the blood.

81. A method according to claim 43 wherein the target structure is selected from a set consisting of exterior jugular vein, subclavian vein, superior vena cava and pulmonary artery.

82. A method according to claim 43 wherein the patient is a neonatal patient.

83. A method according to claim 43 wherein the patient is a fetus.

84. A method according to claim 43 wherein the target structure is located about 2 cm from the skin of the patient.