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

• US 8,644,900 B2
• Filed: 01/23/2012
• Issued: 02/04/2014
• 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-Schechter, Revital, Olshansky, Michal
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/356,053
• Publication Number:
  US 20120184830A1
• Time in Patent Office: 743 Days
• Field of Search: 600310-344, 600/407, 600/437
• 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

Apparatus and methods are provided for monitoring a parameter of a region of interest (ROI) within a first tissue type within a body. A control unit drives a measurement unit to provide an operating condition such that acoustic waves overlap with a region within the ROI that is illuminated by illuminating light such as to generate a first set of tagged photons, and such that the acoustic waves overlap with a region of tissue within a second tissue type that is illuminated by illuminating light such as to generate a second set of tagged photons, the first and second sets of tagged photons being distinguishable from one another. The control unit determines the parameter of the ROI by extracting data portions associated with, respectively, the light response of the ROI and the light response of the second tissue type, by distinguishing between the sets of tagged photons.

Claims

1. Apparatus for non-invasively monitoring at least one parameter of a region of interest within a first tissue type within a human body, the human body including the first tissue type and at least a second tissue type, the apparatus comprising:

a control unit; and

a measurement unit comprising;

an optical unit having an illumination assembly that defines at least one output port configured to generate illuminating light, and a light detection assembly that defines at least one light input port that is configured to detect scattered light and to generate measured data indicative of the detected light; and

an acoustic unit configured to generate acoustic waves,

the control unit being configured to drive the measurement unit to provide an operating condition such that;

the acoustic waves overlap with a region within the region of interest that is illuminated by illuminating light of the illumination assembly such as to generate at least a first set of tagged photons,

the acoustic waves overlap with a region of tissue within the second tissue type that is illuminated by illuminating light of the illumination assembly such as to generate at least a second set of tagged photons, the first and second sets of tagged photons being distinguishable from one another, and

the detection assembly collects;

the first set of tagged photons that were scattered from the region of interest, and

the second set of tagged photons that were scattered from the second tissue type, and

the control unit being further configured to determine said at least one parameter of the region of interest by extracting, from the measured data, data portions associated with, respectively, the light response of the region of interest and the light response of the second tissue type, by distinguishing between the first and second sets of tagged photons.

2. The apparatus according to claim 1, wherein the light detection assembly defines at least first and second light input ports, and wherein the control unit is configured to drive the light detection assembly such that the photons scattered from the region of interest are detected via the first light input port, and the photons scattered from the second tissue type are detected via the second light input port.

3. The apparatus according to claim 1, wherein the illumination assembly defines at least first and second light output ports, and wherein the control unit is configured to drive the illumination assembly to:

illuminate the region within the region of interest with light generated by the first light output port such that the light generated by the first light output port that has been scattered by the region within the region of interest is detected by the at least one input port, and

to illuminate the region of tissue within the second tissue type with light generated by the second output port such that the light generated by the second light output port that has been scattered by the region of tissue within the second tissue type is detected by the at least one input port.

4. The apparatus according to claim 1, wherein the control unit is configured to drive the illumination assembly to illuminate, at different times from one another, the region within region of interest and the region of tissue within the second tissue type.

5. The apparatus according to claim 1, wherein the control unit is configured to drive the illumination assembly such as to illuminate, with illuminating light of different frequencies from one another, the region within region of interest and the region of tissue within the second tissue type.

6. The apparatus according to claim 1, wherein the light detection assembly defines at least first and second light input ports, and wherein the control unit is configured to identify the region of interest and to selectively operate the light input ports in response thereto.

7. The apparatus according to claim 1, wherein the illumination assembly defines at least first and second light output ports, and wherein the control unit is configured to identify the region of interest and to selectively operate the light output ports in response thereto.

8. The apparatus according to claim 1, wherein the control unit is configured to determine the light response of the second tissue type, and to extract from the measured data the data portion associated with the light response of the region of interest based upon the determined light response of the second tissue type.

9. The apparatus according to claim 1, wherein the first tissue type includes fetal tissue and the second tissue type includes maternal tissue, and wherein the control unit is configured to determine the at least one parameter by determining at least one parameter of a region of interest within the fetal tissue.

10. The apparatus according to claim 1, wherein the at least one parameter includes an oxygen saturation parameter of the region of interest, and wherein the control unit is configured to determine the at least one parameter by determining the oxygen saturation parameter of the region of interest.

11. A method for non-invasively monitoring at least one parameter of a region of interest within a first tissue type within a human body, the human body including the first tissue type and at least a second tissue type, the method comprising:

illuminating a region within the region of interest and a region of tissue within the second tissue type with illuminating light;

directing acoustic waves toward the region of interest and tissue of the second tissue type such that;

the acoustic waves overlap with the region within the region of interest that is illuminated by the illuminating light, such as to generate at least a first set of tagged photons, and

the acoustic waves overlap with the region of tissue within the second tissue type that is illuminated by illuminating light of the illumination assembly, such as to generate at least a second set of tagged photons, the first and second sets of tagged photons being distinguishable from one another;

collecting the first set of tagged photons that were scattered from the region of interest, and the second set of tagged photons that were scattered from the second tissue type; and

determining said at least one parameter of the region of interest by extracting, from the measured data, data portions associated with, respectively, the light response of the region of interest and the light response of the second tissue type, by distinguishing between the first and second sets of tagged photons.

12. The method according to claim 11, wherein collecting the first and second sets of tagged photons comprises collecting the first set of tagged photons via a first light input port, and collecting the second set of tagged photons via a second light input port.

13. The method according to claim 11,

wherein illuminating the region within the region of interest comprises illuminating the region within the region of interest with light generated by a first light output port,

wherein collecting the first set of tagged photons that were scattered from the region of interest comprises collecting photons from the light generated by the first light output port,

wherein illuminating the region of tissue within the second tissue type comprises illuminating the region of tissue within the second tissue type with light generated by a second light output port, and

wherein collecting the second set of tagged photons that were scattered from the region of tissue within the second tissue type comprises collecting photons from the light generated by the second light output port.

14. The method according to claim 11, wherein illuminating the region within the region of interest and the region of tissue within the second tissue type with illuminating light comprises illuminating, at different times from one another, the region within the region of interest and the region of tissue within the second tissue type with illuminating light.

15. The method according to claim 11, wherein illuminating the region within the region of interest and the region of tissue within the second tissue type with illuminating light comprises illuminating, with illuminating light of different frequencies from one another, the region within the region of interest and the region of tissue within the second tissue type with illuminating light.

16. The method according to claim 11, further comprising identifying the region of interest and, in response thereto, selecting a light input port for collecting the scattered light.

17. The method according to claim 11, further comprising identifying the region of interest and, in response thereto, selecting a light output port for generating the illuminating light.

18. The method according to claim 11, wherein determining said at least one parameter of the region of interest comprises determining the light response of the second tissue type, and extracting from the measured data the data portion associated with the light response of the region of interest based upon the determined light response of the second tissue type.

19. The method according to claim 11, wherein the first tissue type includes fetal tissue and the second tissue type includes maternal tissue, and wherein determining said at least one parameter of the region of interest comprises determining at least one parameter of a region of interest within the fetal tissue.

20. The method according to claim 11, wherein determining said at least one parameter of the region of interest comprises determining an oxygen saturation parameter of the region of interest.