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

• US 8,108,022 B2
• Filed: 01/09/2006
• Issued: 01/31/2012
• 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-Schechter, Revital, Olshansky, Michal
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US11/327,381
• Publication Number:
  US 20060122475A1
• Time in Patent Office: 2,213 Days
• Field of Search: 600309-344
• 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 including a probe device for monitoring a parameter of a region of interest in a human body. A support structure of the device carries an arrangement of light output ports of a light source assembly, light input ports of a light detection assembly, and an acoustic output port of an acoustic unit. The arrangement is such as to enable selection of a light output port, a light input port, and an acoustic output port for an operating condition at which, acoustic waves from the acoustic output port and illuminating light from the light output port overlap in a region within the region of interest in the body thereby inducing tagging of light by the acoustic waves, and the light input port collects light scattered from the overlapping region and light scattered from outside the region of interest. Other embodiments are also described.

Claims

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

a support structure carrying an arrangement of one or more light output ports of a light source assembly, one or more light input ports of a light detection assembly, and at least one acoustic output port of an acoustic unit,

the arrangement of the light and acoustic ports within the support structure facilitating placement of the at least light output port, the at least one light input port, and the at least one acoustic output port with respect to the body, such that at least one operative light output port, at least one operative light input port, and at least one operative acoustic output port are selectable, so as to provide an operating condition, at which

acoustic waves of a predetermined frequency range coming from said at least one selected acoustic output port and illuminating light coming from said at least one selected light output port overlap in a region within the region of interest in the body, thereby inducing tagging of light by said acoustic waves,

the acoustic waves substantially do not overlap with illuminating light coming from said at least one selected light output port in a region outside the region of interest, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, and

said at least one selected light input port collects tagged light scattered from the overlapping region and substantially untagged light scattered from outside the region of interest; and

a control unit configured to select the at least one operative light output port, the at least one operative light input port, and the at least one operative acoustic output port, so as to provide the operating condition.

2. The probe of claim 1, wherein the support structure is configured such that the arrangement of the light and acoustic ports is such that the light input and output ports are orientable with respect to one another such that the collection of the light by the at least one selected light input port includes the light scattered from the overlapping region, and the light scattered from outside the region of interest the collection of the light from the overlapping region and the light from outside the region of interest enabling identification of a light response of the region of interest.

3. The probe device of claim 1, wherein the support structure is configured such that the arrangement of the light and acoustic ports is configured to provide said condition for the probe operation such that the acoustic waves of the predetermined frequency range from said at least one selected acoustic port and the scattered light, that is irradiated from the at least one selected light output port and is collected by the at least one operative light input port, overlap within the region of interest in the body simultaneously.

4. The probe device of claim 1, wherein the support structure is configured such that said arrangement of light input and acoustic ports within the support structure is adapted to enable selection of one of the light input ports, one of the light output ports, and at least one of the acoustic ports to provide the operating condition.

5. The probe device of claim 1, wherein the support structure is configured such that said arrangement of light input and acoustic ports within the support structure is adapted to enable selection of at least two of the light output ports, at least one of the light input ports, and at least one of the acoustic output ports to provide the operating condition.

6. The probe device of claim 1, wherein the light input ports comprise at least two light input ports arranged in a spaced-apart relationship, and wherein the support structure is configured such that said arrangement of light input and acoustic ports within the support structure is adapted to enable selection of at least one of the light output ports, at least the two light input ports, and at least one of the acoustic output ports to provide the operating condition.

7. The probe device of claim 1, wherein the light input ports comprise an array of at least two light input ports arranged in a spaced-apart relationship, wherein the light output ports comprise an array of at least two light output ports arranged in a spaced-apart relationship, and wherein said arrangement of light input and acoustic ports within the support structure is adapted to enable selection of the array of at least two light output ports, the array of light input ports, and at least one of the acoustic output ports to provide the operating condition.

8. The probe device of claim 1, wherein the acoustic port is configured to provide the acoustic radiation substantially non-collinear with a line connecting the selected operative light input and output ports.

9. The probe device of claim 1, wherein the support structure is configured such that the arrangement of the light and acoustic ports is configured and operable to provide a relative displacement between a direction of propagation of the acoustic radiation and at least one of the light input and output ports.

10. The probe device of claim 1, wherein the support structure carries the light source assembly.

11. The probe device of claim 10, wherein the support structure carries the light detection assembly.

12. The probe device of claim 11, wherein the support structure carries the acoustic unit.

13. The probe device of claim 10, wherein the support structure carries the acoustic unit.

14. The probe device of claim 1, wherein the support structure carries the light detection assembly.

15. The probe device of claim 14, wherein the support structure carries the acoustic unit.

16. The probe device of claim 1, wherein the support structure carries the acoustic unit.

17. The probe device of claim 1, wherein the support structure is flexible such that the support structure is configured to be wrapped around a body portion of the subject that contains the region of interest.

18. The probe device of claim 1, wherein the acoustic unit is configured and operable for generating a type of ultrasound radiation selected from the group consisting of:

continuous wave radiation, pulse radiation, and burst radiation.

19. The probe device of claim 1, wherein the acoustic unit is configured and operable for carrying out a technique selected from the group consisting of:

generating unfocused ultrasound radiation; and

generating focused ultrasound radiation with a focal length corresponding to a distance from the acoustic unit to the region of interest.

20. The probe device of claim 1, wherein the acoustic unit has a configuration selected from the group consisting of:

a configuration in which the acoustic unit comprises a phased array of ultrasound transducers;

a configuration in which the acoustic unit comprises a single-element ultrasound transducer;

a configuration in which the acoustic unit comprises an imaging ultrasound probe; and

a configuration in which the acoustic unit comprises Doppler imaging elements.

21. The probe device of claim 1, wherein the control unit is configured and operable to:

generate measured data indicative of variations of the ultrasound tagged light signal as a function of at least one of time and wavelength of the illuminating light,

analyze the variations of the ultrasound tagged light signal, and

determine at least one predetermined characteristic of the signal and calculate oxygen saturation of the region of interest, said at least one predetermined characteristic including at least one of maxima, minima, and average of the signal.

22. The probe device of claim 1, wherein the light source assembly is configured and operable to carry out at least one 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;

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

23. The probe device of claim 22, wherein the light source 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.

24. The probe device of claim 1, wherein the detection assembly has a configuration selected from the group consisting of:

(i) a configuration in which the detection assembly defines the light input port such that, when in the operating condition of the probe, the light input port detects both the light scattered from the region of interest and the light scattered from the outside of the region of interest;

(ii) a configuration in which the detection assembly defines at least two spaced-apart light input ports, such that 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.

25. The probe device of claim 1, wherein the arrangement of light and acoustic ports is configured 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.

26. The probe device of claim 1, wherein the acoustic unit is configured and operable to generate ultrasound radiation with a frequency range of about 50 kHz-8 MHz.

27. A probe device for use in a system for monitoring at least one parameter of a region of interest in a human body, the probe device comprising:

a support structure carrying;

an array of at least two light output ports arranged in a spaced-apart relationship and being optically coupled to a light source assembly,

an array of light input ports arranged in a spaced-apart relationship and being optically coupled to a light detection assembly, and

at least one acoustic output port of an acoustic unit,

the arrangement of the light ports and the acoustic unit being such as to allow selection of at least one of said light output ports, at least one of the light input ports and at least one of the acoustic output ports, such as to provide an operating condition in which;

acoustic waves of a predetermined frequency range coming from said at least one selected acoustic output port and illuminating light coming from said at least one selected light output port overlap within a region of interest in the body, thereby inducing tagging of light by said acoustic waves,

the acoustic waves substantially do not overlap with illuminating light coming from said at least one selected light output port in a region outside the region of interest, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, and

at least one light input port collects tagged light scattered from the overlapping region and substantially untagged light scattered from outside the region of interest; and

a control unit configured to select the at least one of said light output ports, at least one of the light input ports, and at least one of the acoustic output ports, so as to provide the operating condition.

28. A probe device for use in a system for monitoring at least one parameter of a region of interest in a human body, the probe device comprising:

a support structure canying at least one light output port optically coupled to a light source assembly, at least two light input ports optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

the arrangement of the light and acoustic ports being such as to allow selection of at least one of the light input ports and at least one of the acoustic output ports, such as to provide an operating condition in which;

acoustic waves of a predetermined frequency range coming from said at least one selected acoustic output port and illuminating light coming from said at least one selected light output port overlap within a region of interest in the body, thereby inducing tagging of light by said acoustic waves,

the acoustic waves substantially do not overlap with illuminating light coming from said at least one selected light output port in a region outside the region of interest, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, and

said at least one light input port collects tagged light scattered from the overlapping region and substantially untagged light scattered from outside the region of interest; and

a control unit configured to select the at least one of the light input ports and at least one of the acoustic output ports, so as to provide the operating condition.

29. A probe device for use in a system for monitoring at least one parameter of a region of interest in a human body, the probe device comprising:

a support structure carrying at least two light output port optically coupled to a light source assembly, at least one light input port optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

the arrangement of the light and acoustic ports being such as to allow selection of at least one of said light output ports, at least one of the light input ports and at least one of the acoustic output ports, such as to provide an operating condition in which;

acoustic waves of a predetermined frequency range coming from said at least one selected acoustic output port and illuminating light coming from said at least one selected light output port overlap within a region of interest in the body, thereby inducing tagging of light by said acoustic waves,

the acoustic waves substantially do not overlap with illuminating light coming from said at least one selected light output port in a region outside the region of interest, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, and

said at least one light input port collects tagged light scattered from the overlapping region and substantially untagged light scattered from outside the region of interest; and

a control unit configured to select the at least one of said light output ports, at least one of the light input ports and at least one of the acoustic output ports, so as to provide the operating condition.

30. A probe device for use in a system for monitoring at least one parameter of a region of interest in a human body, the probe device comprising:

a support structure having a configuration selected from the group consisting of;

(i) a configuration in which the support structure carries at least two light output port optically coupled to a light source assembly, at least one light input port optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

(ii) a configuration in which the support structure carries at least one light output port optically coupled to a light source assembly, at least two light input ports optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit, and

(iii) a configuration in which the support structure carries an array of at least two light output ports arranged in a spaced-apart relationship and being optically coupled to a light source assembly, an array of light input ports arranged in a spaced-apart relationship and being optically coupled to a light detection assembly, and at least one acoustic output port of an acoustic unit,

the arrangement of the light and acoustic ports being such as to allow selection of at least one of said light output ports, at least one of said light input ports and at least one of the acoustic output ports such as to provide an operating condition in which;

acoustic waves of a predetermined frequency range coming from said at least one selected acoustic output port and illuminating light coming from said at least one selected light output port overlap within a region of interest in the body, thereby inducing tagging of light by said acoustic waves,

the acoustic waves substantially do not overlap with illuminating light coming from said at least one selected light output port in a region outside the region of interest, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, the light outside the region of interest thereby substantially not being tagged by said acoustic waves, and

said at least one light input port collects tagged light scattered from the overlapping region and substantially untagged light scattered from outside the region of interest; and

a control unit configured to select the at least one of said light output ports, at least one of said light input ports and at least one of the acoustic output ports, so as to provide the operating condition.