Method and apparatus for noninvasively monitoring parameters of a region of interest in a human body

• US 8,126,524 B2
• Filed: 09/12/2004
• Issued: 02/28/2012
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: OrNim Medical, Ltd. (OrNim, Inc.)
• Original Assignee: OrNim Medical, Ltd. (OrNim, Inc.)
• Inventors: Balberg, Michal, Pery-Shechter, Revital, Olshansky, Michal
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US10/545,798
• Publication Number:
  US 20060247506A1
• Time in Patent Office: 2,725 Days
• Field of Search: 600310-344, 600/509, 600/439
• US Class Current: 600/310
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0097 by applying acoustic waves and detecting light, i.e. acoustooptic measurements
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G01S 15/8968 using acoustical modulation of a light beam acousto-optical light control devices G02F1/11, G02F1/33

Abstract

A method and system for noninvasive monitoring of at least one parameter of a region of interest in a human body. The system comprises a measurement unit and a control unit. The measurement unit comprises an optical unit having an illumination assembly (101A) and a light detection assembly (101B) to generate measured data indicative of collected light; and an acoustic unit (110) configured to generate acoustic waves of a predetermined ultrasound frequency range. The measurement unit provides an operating condition such that the acoustic waves overlap with an illuminating region within the region of interest and substantially do not overlap outside the region of interest. The measured data is indicative of scattered light having both ultrasound tagged and untagged light portions, enabling to distinguish between light responses of the region of interest and the region outside the region of interest.

Claims

1. A monitoring system for use in non-invasively monitoring at least one parameter of a region of interest in a human body, the system comprising:

a measurement unit comprising;

an optical unit having an illumination assembly configured to define at least one output port for illuminating light, and a light detection assembly configured to define at least one light input port for collecting light scattered from the illuminated body portion and to generate measured data indicative of the collected light; and

an acoustic unit configured to generate acoustic waves of a predetermined ultrasound frequency range;

the measurement unit being configured and operable to provide an operating condition such that the acoustic waves of the predetermined frequency range overlap with an illuminating region within the region of interest and substantially do not overlap with a region outside the region of interest, and that the detection assembly collects light scattered from the region of interest and light scattered from the region outside the region of interest, the measured data being thereby indicative of scattered light having both ultrasound tagged and untagged light portions; and

a control unit, which is connectable to the optical unit and to the acoustic unit to operate these units,

the control unit being responsive to the measured data and preprogrammed to;

process and analyze the measured data to extract therefrom a data portion associated with the light response of the region of interest and determine said at least one parameter of the region of interest, by;

interpreting the tagged light portions as having been at least partially scattered by the region of interest,

interpreting the untagged light portions as having been scattered by the region outside of the region of interest, and

extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest, based on the untagged light portions of the measured data.

2. The system of claim 1, wherein the acoustic unit is configured for generating ultrasound radiation selected from the group consisting of:

unfocused radiation, and focused radiation with a focal length corresponding to a distance from the acoustic unit to the region of interest.

3. The system of claim 1, wherein the control unit is configured to determine oxygen saturation of the region of interest.

4. The system of claim 1, wherein the control unit is configured to utilize principles of oximetry or pulse oximetry to determine the desired parameter of the region of interest.

5. The system of claim 1, wherein the measurement unit is configured and operable to generate the measured data indicative of variations of the ultrasound tagged light portion as a function of at least one of time and wavelength of the illuminating light, the control unit being configured to analyze the variations of the ultrasound tagged light portion to determine at least one predetermined characteristic of the portion and calculate oxygen saturation, said at least one predetermined characteristic of the portion including maxima, minima and average of the portion.

6. The system of claim 1, wherein the control unit is preprogrammed and operable to provide optimal positioning of the optical unit and the acoustic unit, said optimal positioning satisfying said operating condition.

7. The system of claim 6, wherein the control unit is operable to provide a relative displacement between a direction of propagation of the acoustic radiation and at least one of the illumination and detection assemblies so as to provide said optimal positioning.

8. The system of claim 7, wherein the control unit is operable to displace at least one of the light input or output ports with respect to the direction of the acoustic waves propagation.

9. The system of claim 1, wherein the illumination assembly is configured to define at least two spaced-apart light output ports.

10. The system of claim 9, wherein the control unit is operable to select at least one of the light output ports for measurements, to provide said operating condition.

11. The system of claim 10, wherein the detection assembly is configured to define at least two spaced-apart light input ports.

12. The system of claim 11, wherein the control unit is operable to select at least one of the light input ports for measurements, to provide said operating condition.

13. The system of claim 1, wherein the detection assembly has a configurations selected from the group consisting of:

(a) a configuration in which the detection assembly is configured to define at least two spaced-apart light input ports; and

(b) a configuration in which the detection assembly is configured to define an array of at least two spaced-apart light input ports,

such that when in the operating condition, at least one of the light input ports collects the tagged light coming from the region of interest, and at least one other of the light input ports collects the untagged light scattered from the region outside the region of interest.

14. The system of claim 13, wherein the control unit is preprogrammed for operating at least one of the light input ports a predetermined time after the operation of the acoustic unit, thereby providing said operating condition.

15. The system of claim 14, wherein said predetermined time corresponds to a time needed for the acoustic waves of the predetermined frequency range to reach the region where the overlapping with the illuminating light is to be provided.

16. The system of claim 15, wherein

said at least one of the light input ports is located proximate of the light output port thereby collecting untagged light scattered from the region outside of the region of interest;

and

said at least one other light input port is located at a larger distance from the light output port as compared to a location of at least one other light input port thereby collecting tagged light coming from the region of interest through the region outside of the region of interest.

17. The system of claim 16, wherein the control unit is preprogrammed

to process and analyze a first set of measured data generated by said at least one light input port to determine data indicative of a characteristic of a light response of the region outside of the region of interest to the illuminating light;

and

to utilize said first set of data indicative of the light response characteristic in the processing and analyzing of a second set of measured data generated by said at least one other input port to thereby extract the light response of the region of interest.

18. The system of claim 13, wherein the control unit is operable to select at least one of the light input ports for measurements, to provide said operating condition.

19. The system of claim 13, wherein said at least two light input ports are arranged such that

at least one of the light input ports is located proximate of the light output port thereby collecting untagged light scattered from the region outside of the region of interest;

and

the at least one other light input port is located at a larger distance from the light output port thereby collecting ultrasound tagged light coming from the region of interest through the outside region.

20. The system of claim 19, wherein the control unit is preprogrammed

to process and analyze a first set of measured data generated by said at least one light input port to determine data indicative of a characteristic of a light response of the region outside of the region of interest to the illuminating light;

and

to utilize said first set of measured data indicative of the light response characteristic in the processing and analyzing of a second set of measured data generated by said at least one other input port to thereby extract the light response of the region of interest.

21. The system of claim 1, wherein the illumination assembly is configured and operable to generate the illuminating light of at least two different wavelengths.

22. The system of claim 21, wherein the illumination assembly is operable to generate said at least two different wavelengths at different times.

23. The system of claim 22, wherein the at illumination assembly is operable to generate the at least two wavelengths, the wavelengths being differently modulated by at least one characteristic selected from the group consisting of frequency and phase characteristics.

24. The system of claim 21, wherein the illumination assembly is operable to generate the at least two wavelengths, the wavelengths being differently modulated by at least one characteristic selected from the group consisting of frequency and phase characteristics.

25. The system of claim 21, wherein the illumination assembly is configured and operable to generate the illuminating light of at least three different wavelengths,

of which two of the wavelengths are characterized, with respect to one another, by having the same absorption by tissue or fluid components in the body and as being differently scattered by the tissue or fluid components in the body, and

of which two of the wavelengths are characterized, with respect to one another, by having different absorption by the tissue or fluid components in the body.

26. The system of claim 1, wherein the detection assembly is configured to define the light input port which, when in the operating condition, detects both the light scattered from the region of interest and the light scattered from the outside of the region of interest.

27. The system of claim 1, wherein the control unit is preprogrammed for operating the optical unit a predetermined time after the operation of the acoustic unit, thereby providing said operating condition.

28. The system of claim 27, wherein said control unit is preprogrammed such that said predetermined time corresponds to a time needed for the acoustic waves of the predetermined frequency to reach the region where the overlapping with the illuminating light is to be provided.

29. The system of claim 1, wherein the control unit is configured and operable

to actuate the optical and acoustic units to irradiate with the acoustic radiation a plurality of regions in the illuminated part of the body and detect scattered photons;

and

to analyze the measured data to identify tagged and untagged light portions associated with each of said plurality of regions to determine a parameter indicative of the light response of each of said plurality of regions, thereby enabling identification of said region of interest.

30. The system of claim 1, comprising a support structure carrying at least the light output and light input ports of the illumination and detection assemblies.

31. The system of claim 30, wherein said support structure has at least one configuration selected from the group consisting of:

(i) a configuration in which the support structure is configured for carrying the illumination and detection assemblies;

(ii) a configuration in which the support structure is configured for carrying the acoustic unit;

(iii) a configuration in which the support structure is configured for carrying an output port of the acoustic unit; and

(iv) a configuration in which the support structure is flexible to wrap around the body portion.

32. The system of claim 1, wherein the acoustic unit is configured for generating ultrasound radiation in a form selected from the group consisting of:

continuous wave, pulse, and burst.

33. The system of claim 1, wherein the control unit is configured and operable to apply a frequency filtering to the output of the detection assembly to correspond to a frequency bandwidth of the acoustic waves irradiating the region of interest.

34. The system of claim 1, wherein the acoustic unit comprises a phased array of ultrasound transducers.

35. The system of claim 1, wherein the control unit is configured for carrying out at least one technique selected from the group consisting of:

receiving data indicative of reflections of the ultrasound waves from an irradiated volume inside of the body for creating data indicative of an image of the irradiated volume, and analyzing said image data to provide said operating condition for measurements; and

receiving data indicative of reflections of the ultrasound waves from an irradiated volume inside the body for determining data indicative of a Doppler shift in the ultrasound radiation reflections.

36. The system of claim 1, wherein said predetermined frequency range of the ultrasound radiation is from 50 kHz to 8 MHz.

37. The system of claim 1, wherein the ultrasound radiation is of a frequency lower than 1 MHz.

38. The system of claim 1, wherein the system is configured for use in monitoring at least one parameter selected from the group consisting of:

oxygen saturation level of the region of interest, and concentration of a substance or structure in the region of interest.

39. A method for use in noninvasive monitoring at least one parameter of a region of interest in a human body, the method comprising:

operating an optical unit and an acoustic unit so as to provide that ultrasound waves of a predetermined frequency range and illuminating light overlap within the region of interest and substantially do not overlap with a region outside the region of interest,

thereby producing measured data indicative of collected light including scattered light having ultrasound tagged and untagged light portions,

interpreting the tagged light portions as having been at least partially scattered by the region of interest,

interpreting the untagged light portions as having been scattered by the region outside of the region of interest, and

extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest, based on the untagged light portions of the measured data.

40. The method of claim 39, wherein operating the acoustic unit comprises irradiating the region of interest with unfocused or focused ultrasound radiation.

41. The method of claim 39, further comprising determining oxygen saturation of the region of interest, based upon the extracted data portion.

42. The method of claim 39, further comprising utilizing principles of oximetry or pulse oximetry to determine the parameter of the region of interest, based upon the extracted data portion.

43. The method of claim 39, wherein operating the optical unit comprises applying the illumination of at least two different wavelengths, and producing measured data indicative of variations of the ultrasound tagged light portion as a function of at least one parameter selected from the group consisting of time and wavelength of the illuminating light.

44. The method of claim 43, further comprising analyzing the time variations to determine at least one predetermined characteristic of the tagged light portion and calculate oxygen saturation of the region of interest, said at least one predetermined characteristic being selected from the group consisting of maxima, minima and average of the portion.

45. The method of claim 39, wherein operating the optical unit and the acoustic unit comprises providing a relative displacement between a direction of propagation of the acoustic radiation and at least one assembly selected from the group consisting of:

an illumination assembly and detection assembly of the optical unit.

46. The method of claim 45, wherein operating the optical unit and the acoustic unit comprises displacing at least one of light input or light output ports of the optical unit with respect to the direction of the acoustic waves propagation.

47. The method of claim 45, wherein operating the optical unit and the acoustic unit comprises carrying out a technique selected from the group consisting of:

(a) inserting the acoustic unit into the body through an opening, and locating the optical unit outside the body, during a monitoring procedure; and

(b) inserting the optical unit into the body through an opening, and locating the acoustic unit outside the body, during a monitoring procedure.

48. The method of claim 47, wherein the opening includes a vaginal tract, the method comprising inserting into the vaginal tract a unit selected from the group consisting of the acoustic unit and the optical unit.

49. The method of claim 39, wherein operating the optical unit comprises selecting for measurements at least one light output port, from a plurality of spaced-apart light output ports, of the optical unit.

50. The method of claim 49, wherein operating the optical unit comprises selecting for measurements at least one light input port from a plurality of spaced-apart light input ports of the optical unit.

51. The method of claim 39, wherein operating the optical unit comprises selecting for measurements at least one light input port from a plurality of spaced-apart light input ports of the optical unit.

52. The method of claim 39, wherein operating the acoustic unit comprises applying ultrasound imaging to the region of interest surrounded by the outside region.

53. The method of claim 52, wherein applying the ultrasound imaging comprises applying the ultrasound imaging using said acoustic unit.

54. The method of claim 39, wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest comprises monitoring at least one parameter of the region of interest during therapeutic application of ultrasound radiation or light radiation thereto.

55. The method of claim 54, further comprising applying the therapeutic ultrasound radiation using said acoustic unit.

56. The method of claim 39, further comprising detecting reflections of the ultrasound radiation from the irradiated body portion and determining a Doppler shift in the detected reflections.

57. The method of claim 39, wherein operating the optical unit comprises operating an illumination assembly of the optical unit to carry out a technique selected from the group consisting of:

(a) generating the illuminating light of at least two different wavelengths;

(b) generating the illuminating light of at least two different wavelengths at different times; and

(c) generating the illuminating light of at least two different wavelengths differently modulated by at least one of frequency and phase characteristics.

58. The method according to claim 57, wherein operating the optical unit comprises operating an illumination assembly of the optical unit to generate the illuminating light of at least three different wavelengths,

of which two of the wavelengths are characterized, with respect to one another, by having the same absorption by tissue or fluid components in the body and as being differently scattered by the tissue or fluid components in the body, and

of which two of the wavelengths are characterized, with respect to one another, by having different absorption by the tissue or fluid components in the body.

59. The method of claim 39, further comprising detecting both the light scattered from the region of interest and the light scattered from the outside of the region of interest.

60. The method of claim 39, wherein operating the optical unit and the acoustic unit comprises operating at least two spaced-apart light input ports of the optical unit to provide at least one light collection condition selected from the group consisting of:

(i) at least one of the light input ports collects the light scattered from the region of interest, and at least one other of the light input ports collects the light scattered from the outside region;

(ii) at least one of the light input ports collects the untagged light scattered from the region outside the region of interest, and at least one other of the light input ports collects the tagged light coming from the region of interest through the region outside the region of interest.

61. The method of claim 60, wherein operating the optical unit and the acoustic unit comprises collecting the untagged light scattered from the region outside of the region of interest by said at least one light input port located proximate of the light output port, and collecting the tagged light coming from the region of interest through the region outside the region of interest by said at least one other light input port located at a larger distance from the light output port.

62. The method of claim 61, wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest, based on the untagged light portion of the measured data comprises:

processing and analyzing a first set of measured data generated by said at least one light input port to determine data indicative of a characteristic of a light response of the region outside the region of interest to the illuminating light; and

utilizing said first set of measured data indicative of the light response characteristic in processing and analyzing of a second set of measured data generated by said at least one other light input port, to thereby extract from the second measured data the data indicative of the light response of the region of interest.

63. The method of claim 39, wherein operating the optical unit and the acoustic unit comprises operating the optical unit a predetermined time after the operation of the acoustic unit, said predetermined time corresponding to a time needed for the acoustic waves of the predetermined frequency range to reach the region of interest where the overlapping with the illumination light is to be provided.

64. The method of claim 39,

wherein said at least one parameter includes at least one parameter selected from the group consisting of:

oxygen saturation level; and

concentration of a substrate or structure in the region of interest; and

wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest comprises facilitating monitoring of the selected parameter.

65. The method of claim 39, wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest comprises facilitating noninvasive monitoring of a fetus condition.

66. The method of claim 65,

wherein said at least one parameter includes at least one parameter selected from the group consisting of:

a fetus blood parameter;

an oxygen saturation level of the fetus;

concentration of a substance or a structure within the fetus;

concentration of a substance or a structure within amniotic fluid;

presence of meconium in the amniotic fluid and concentration thereof;

presence of blood in the amniotic fluid and concentration thereof; and

a level of lung maturity of the fetus; and

wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest comprises facilitating monitoring of the selected parameter.

67. The method of claim 65, wherein said at least one parameter includes the level of lung maturity of the fetus, the method further comprising determining presence and concentration of lamellar bodies in the amniotic fluid, based upon the extracted data portion.

68. The method of claim 39, wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest comprises facilitating monitoring optical properties of an extravascular fluid selected from the group consisting of:

pleural fluid, pericardial fluid, peritoneal fluid and synovial fluid.

69. A method for use in noninvasive monitoring oxygen saturation level, the method comprising:

applying ultrasound tagging of light in pulse oxymetric measurements,

obtaining measured data indicative of variations of collected light as a function of both time and wavelength of illuminating light, the collected light including scattered light having ultrasound tagged and untagged light portions,

interpreting the tagged light portions as having been at least partially scattered by a region of interest,

interpreting the untagged light portions as having been scattered by a region outside of the region of interest, and

extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the region of interest, based on the untagged light portion of the measured data, and

analyzing the data portion associated with the light response of the region of interest to calculate the oxygen saturation level of the region of interest.

70. A method for use in noninvasive monitoring at least one parameter of a fetus-related region of interest, the method comprising:

providing an optical unit having

an illumination assembly configured to define at least one output port for the illuminating light; and

a light detection assembly configured to define at least one light input port for collecting light, and to generate measured data indicative of the collected light; and

providing an acoustic unit configured to generate acoustic waves of a predetermined ultrasound frequency range;

providing an optimal positioning of the optical and acoustic units with respect to each other and with respect to the fetus-related region of interest, said optimal positioning satisfying an operating condition resulting in that the ultrasound waves of the predetermined frequency range overlap with the illuminating light within the fetus-related region of interest, while substantially not overlapping in a maternal tissues region outside the fetus-related region of interest, and in that the detection assembly collects light scattered from the fetus-related region of interest and from the maternal tissues region;

operating the optical and acoustic units, when in the optimal positioning, and generating measured data indicative of collected light including scattered light having ultrasound tagged and untagged light portions,

interpreting the tagged light portions as having been at least partially scattered by the fetus-related region of interest,

interpreting the untagged light portions as having been scattered by the maternal tissues region outside of the fetus-related region of interest, and

extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the fetus-related region of interest, based on the untagged light portions of the measured data.

71. The method of claim 70, wherein extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the fetus-related region of interest comprises extracting, from the tagged light portion of the measured data, the data portion associated with the light response of the fetus-related region of interest selected from the group consisting of:

a fetus-related region of interest containing the fetus only, and a fetus-related region of interest containing the fetus and amniotic fluid regions.

72. The method of claim 71,

wherein said at least one parameter includes at least one parameter selected from the group consisting of oxygen saturation level, and concentration of a substance in the fetus region, and concentration of a structure in the fetus region, and

wherein extracting, from the tagged light portion of the measured data, the data portion associated in the light response of the fetus-related region of interest comprises facilitating monitoring of the selected parameter.

73. The method of claim 72,

wherein said at least one parameter includes at least one parameter selected from the group consisting:

a level of lung maturity of the fetus;

presence of lamellar bodies;

concentration of lamellar bodies;

presence of meconium;

concentration of meconium;

presence of blood; and

concentration of blood, and

wherein extracting, from the tagged light portion of the measured data, the data portion associated in the light response of the fetus-related region of interest comprises facilitating monitoring of the selected parameter.