System and method for measuring blood parameters

• US 9,913,602 B2
• Filed: 07/02/2013
• Issued: 03/13/2018
• Est. Priority Date: 07/06/2012
• Status: Active Grant

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Weinstein, Aharon, Gandelman, Yosef
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/413,078
• Publication Number:
  US 20150157247A1
• Time in Patent Office: 1,715 Days
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

The present invention provides techniques for measuring one or more parameters of a subject using a probe having an optical assembly configured and operable for applying optical measurements to a measurement location in a subject and generating optical measured data indicative thereof comprising at least one of pulsatile and occlusion measurements, a pressure system configured and operable for controllably applying pressure to the subject in the vicinity of the measurement location and measuring pressure inside the pressure system and generating pressure data indicative thereof, and a control system configured and operable for receiving and processing the pressure data to identify whether the optical measured data is valid, and for processing the valid optical measured data and determining at least one relation between the valid optical measured data and the corresponding pressure data indicative of at least one parameter of the subject.

Claims

1. A system for measuring level of at least one analyte of a subject, the system comprising:

a probe for attaching to the subject, said probe carrying an optical assembly configured and operable for applying optical measurements to a measurement location in the subject and generating optical measured data indicative thereof, the optical measurements comprising measurements taken from the measurement location in at least one of pulsatile and occlusive blood states;

an auxiliary system comprising a pressure system configured and operable for controllably applying pressure to the subject in the vicinity of the measurement location and affecting at least one of said pulsatile and occlusive blood states at the measurement location, and a pressure sensor system in fluid connection with the pressure system for measuring changes of pressure inside the pressure system during the application of said pressure to the subject in the vicinity of the measurement location and generating pressure data, said pressure data being thereby indicative of the pressure changes in the pressure system caused by volumetric changes in the measurement location to which said pressure is being applied; and

a control system configured and operable for receiving and processing the pressure data and the optical measured data, determining at least one relation between the optical measured data and the corresponding pressure data, and analyzing said at least one relation for determining the at least one analyte of the subject.

2. A system according to claim 1, wherein the pressure system comprises at least one expandable element carried by the probe and being configured and operable to be shiftable between its unexpanded and expanded states to thereby selectively permit said pulsatile blood state and create said occlusive blood state in the measurement location respectively.

3. A system according to claim 2, wherein the pressure system comprises a pressure source fluidly coupled to the at least one expandable element and configured and operable to apply a fluid pressure operable to shift said expandable element into the expanded state.

4. A system according to claim 3, wherein said pressure sensor system comprises a pressure vessel fluidly coupled to at least one of the pressure source and the at least one expandable element and configured and operable to hold a volume of pressurized fluid, such that pressure of the pressurized fluid in said pressure vessel changes in accordance with the volumetric changes in the measurement location to which said pressure is being applied.

5. A system according to claim 4, wherein a volume of the pressure vessel is greater than a summation of volumes of the at least one expandable element and of elements in the system coupled thereto, to thereby increase a ratio of pressure system volume to vasculature volume at the measurement location.

6. A system according to claim 5, wherein the volume of the pressure vessel is at least twice the summation of volumes.

7. A system according to claim 1, comprising a barometric pressure sensing element configured and operable to measure atmospheric pressure of an environment external to said system and generate barometric data indicative thereof, the control system is configured and operable to use said barometric data to compensate effects of said atmospheric pressure on the pressure measurement data.

8. A system according to claim 1 comprising a temperature sensor configured and operable to measure temperature at the measurement location and generate temperature data indicative thereof, the control system is configured and operable to use said temperature data to correct influence of temperature on at least one of the pressure and optical measurement data.

9. A system according to claim 1, wherein said probe defines a probing cavity for holding a body portion of the subject such as to bring a measurement location in said body portion into a measurement position, said probe being configured and operable to adjust a size of the probing cavity to geometry of said body portion.

10. A system according to claim 9 wherein the at least one expandable element is movably disposed inside the adjustable probing cavity.

11. A system according to claim 9, comprising a locking mechanism configured and operable to immobilize movable parts associated with the adjustable cavity to set said adjustable cavity into a locked state.

12. A system according to claim 11, wherein the locking mechanism includes at least one inflatable member fluidly coupled to a pressure source and configured and operable to receive fluid pressure therefrom and responsively change said locking mechanism into the locked state for immobilizing the movable parts and setting a desired size of said adjustable cavity.

13. A system according to claim 9 wherein the probe comprises a housing having bottom and upper hollow portions telescopically movable one relative to the other, movement of said hollow portions defines the size of the adjustable probing cavity, and wherein said locking mechanism is configured and operable to stop movement of said hollow portions in the locked state.

14. A system according to claim 13 wherein the housing comprises a movable plate fixedly coupled to the upper hollow portion and elastically coupled to the bottom hollow portion for applying pressure over the body portion held in the probing cavity.

15. A system according to claim 1 wherein the control system is configured and operable to validate the measured data based on at least one of the pressure and the optical measurement data.

16. A system according to claim 1 wherein the at least one analyte comprises at least one of hemoglobin and Oxygen saturation.

17. A system according to claim 1 wherein the determining of the at least one analyte by the control system comprises at least one of the following:

determining an AC/DC ratio from either the optical measurement data or the pressure measurement data; and

determining a parametric slope based on at least one of the optical measurement data and the pressure measurement data.

18. A system according to claim 1 wherein the control system is configured and operable to validate the measured data based on at least one of the following:

an AC/DC ratio determined based on either the optical measurement data or the pressure measurement data; and

a parametric slope determined based on at least one of the optical measurement data and the pressure measurement data.

19. A system according to claim 1 wherein the control system is configured and operable to determine the at least one analyte of the subject by computing a combination of the determined at least one relation between the optical measured data and the corresponding pressure data with a plurality of calibration coefficients.

20. A system according to claim 1 wherein the control system is configured and operable to determine the at least one analyte of the subject based on a parametric slope derived at least from the optical data.

21. A system for measuring level of at least one analyte of an examined tissue, the system comprising:

at least one expandable element configured and operable to apply pressure to a vicinity of a measurement location on the tissue, to permit a pulsatile blood state in said tissue in an unexpanded state of the expandable element, and to apply an occlusive blood state in said tissue in an expanded state thereof;

an optical assembly configured to detect light response of the measurement location to incident light and generate optical measurement data indicative of the detected light response, while the examined tissue is in at least one of said pulsatile and occlusive blood states;

a pressure sensor fluidly coupled to said at least one expandable element and being configured and operable to generate pressure measurement data indicative of pressure applied to said at least one expandable element from said tissue being in at least one of said pulsatile and occlusive blood states; and

a processor configured to process said pressure and optical measurement data, validate at least one of said optical and pressure measurement data based on at least one of the measurements data, and whenever it is determined that said data is valid calculate at least one relation between the optical and the pressure measurement data, said at least one relation being indicative of said at least one analyte of the examined tissue.

22. A method for measuring by a computerized device level of at least one analyte in a subject, said computerized device comprising at least one processor and one or more memories for storing instructions executable by said at least one processor and configured to carry out the following:

operating a pressure system for applying pressure to the subject in the vicinity of a measurement location in the subject and affecting at least one of pulsatile and occlusive blood states at said measurement location;

receiving from an optical assembly configured to communicate with said computerized device optical measured data taken from said measurement location while in said at least one of the pulsatile and occlusive blood states;

receiving from a pressure sensor being in fluid connection with the pressure system and configured to communicate with said computerized device pressure data indicative of pressure changes inside the pressure system that are due to vascular volumetric changes in the measurement location in the subject while in the at least one of the pulsatile and occlusive blood states during which the optical measured data is obtained;

processing the optical measured data and the pressure data and determining at least one relation between said optical measured data and said pressure data; and

determining said at least one analyte of the subject based on said at least one relation.

23. A method according to claim 22 wherein the processing of the measured data by the computerized device comprises validating the measured data based on at least one of the pressure data and the optical measured data.

24. A method according to claim 22 wherein the processing of the measured data by the computerized device comprises filtering artifacts from the measurement data based on at least one of the optical measured data and the pressure data.

25. A method according to claim 22 wherein the determining of the at least one analyte of the subject by the computerized device comprises determining at least one of the following:

an AC/DC ratio from either the optical measurement data or the pressure measurement data; and

a parametric slope determined based on at least one of the optical measurement data and the pressure measurement data.

26. A method according to claim 22 comprising determining at least one calibration coefficient based on data obtained in vivo from healthy and unhealthy subjects and using said at least one calibration coefficients in the determining of the at least one analyte.

27. A method according to claim 22 wherein the at least one analyte comprises at least one of hemoglobin and Oxygen saturation.

28. A method according to claim 22 wherein the processing of the measured data by the computerized device comprises validating the measured data based on at least one of the following:

an AC/DC ratio determined based on either the optical measurement data or the pressure measurement data; and

a parametric slope determined based on at least one of the optical measurement data and the pressure measurement data.

29. A method according to claim 22 wherein the computerized device is configured to operate the optical assembly to apply at least two light signals of different wavelengths through examined tissue at the measurement location while in the at least one of the pulsatile and occlusive blood states, and wherein the optical measured data is indicative of passage of the at least two light signals of different wavelengths through the examined tissue in the at least one of the pulsatile and occlusive blood states.

30. A method according to claim 29 wherein at least one of the wavelengths is a reference wavelength, and wherein the pressure data is indicative of vascular volumetric changes during application of light of said reference wavelength.