WO2017089479A1 - Non-invasive human condition monitoring device - Google Patents

Non-invasive human condition monitoring device Download PDF

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Publication number
WO2017089479A1
WO2017089479A1 PCT/EP2016/078707 EP2016078707W WO2017089479A1 WO 2017089479 A1 WO2017089479 A1 WO 2017089479A1 EP 2016078707 W EP2016078707 W EP 2016078707W WO 2017089479 A1 WO2017089479 A1 WO 2017089479A1
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WO
WIPO (PCT)
Prior art keywords
signal
doppler shift
biological tissue
module
lymph
Prior art date
Application number
PCT/EP2016/078707
Other languages
French (fr)
Inventor
Edik Rafailov
Sergei SOKOLOVSKY
Viktor Vasilyevich SIDOROV
Original Assignee
Aston University
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Publication date
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Publication of WO2017089479A1 publication Critical patent/WO2017089479A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0071—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414—Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/418—Evaluating particular organs or parts of the immune or lymphatic systems lymph vessels, ducts or nodes

Definitions

  • the invention relates to a device for monitoring a human condition non-invasively by monitoring an optical response of an illuminated region of tissue.
  • the invention relates to a monitoring device, which may be wearable e.g. on a subject's wrist, that is suitable for simultaneous detection of red blood cell and lymph microcirculations.
  • the monitoring device may also monitor metabolic biomarker fluorescence of the skin.
  • US 7,130,672 discloses an apparatus for monitoring a plurality of tissue viability parameters. It includes two different illumination sources. A first illumination source is used to monitor blood/lymph flow rate, whilst a second illumination source is used to excite nicotinamide adenine dinucleotide (NADH) fluorescence.
  • a first illumination source is used to monitor blood/lymph flow rate
  • a second illumination source is used to excite nicotinamide adenine dinucleotide (NADH) fluorescence.
  • NADH nicotinamide adenine dinucleotide
  • the present invention provides a monitoring device capable of non-invasive simultaneous detection of flow properties of both red blood cells (RBC) and lymph contrast objects using Doppler flowmetry. It is advantageous to measure both blood microcirculation and lymph microcirculation because the combination provides better (i.e. richer) diagnostic information.
  • RBC red blood cells
  • lymph contrast objects using Doppler flowmetry.
  • the device may also function as a fluorimeter, i.e. to excite and detect autofluorescent signals from biomarkers in irradiated tissue.
  • a non-invasive human condition monitoring device comprising: a source of infrared radiation arranged to emit an infrared illumination pattern onto biological tissue
  • a processing module arranged to analyse the first signal and the second signal to independently determine: a first Doppler shift associated with the first signal, the first Doppler shift being indicative of red blood cell (RBC) flow velocity in the biological tissue, and a second Doppler shift associated with the second signal, the second Doppler shift being indicative of lymph contrast object flow velocity in the biological tissue.
  • RBC red blood cell
  • the source of infrared radiation may be arranged to output radiation at a single stable frequency.
  • the source of infrared radiation may be a laser diode.
  • the infrared radiation may have a wavelength in the range 800 to 1100 nm.
  • the photodetector module may comprise a first
  • photodetector for detecting the first signal and a second photodetector for detecting the second signal .
  • physically separate detectors may be provided to obtain the first signal and the second signal.
  • the processing module may be arranged to filter the first signal to remove frequencies outside an expected RBC Doppler shift frequency band.
  • the expected RBC Doppler shift frequency band may correspond to RBC flow rates in the range 0.1 to 4 mm/s .
  • the expected RBC Doppler shift frequency band may be 250 to 11,000 Hz.
  • the processing module may be arranged to filter the second signal to remove frequencies outside an expected lymph contrast object Doppler shift frequency band.
  • the expected lymph contrast object Doppler shift frequency band may be different from the expected RBC Doppler shift frequency band.
  • the expected lymph contrast object Doppler shift frequency band may be 0 to 150 Hz. Filtering the signal can remove unwanted noise and reduce the processing burden of subsequent analysis steps .
  • the device may include an analysis module arranged to determine one or more microcirculation parameters based on the first Doppler shift and the second Doppler shift.
  • the analysis module may be arranged to perform wavelet analysis on the first signal and the second signal (preferably after the filtering discussed above) to extract information indicative of the one or more microcirculation parameters.
  • the one or more microcirculation parameters can include any one or more of: myogenic, endothelial, neurogenic, breathing and pulse oscillations .
  • the device may include a source of ultraviolet radiation arranged to emit an
  • the photodetector module may be arranged to detect a fluorescent response from the biological tissue triggered by the ultraviolet illumination pattern.
  • the photodetector module is arranged to detect a plurality of fluorescent responses, each of the plurality of fluorescent responses being associated with a respective biomarker.
  • the photodetector module may comprise a plurality of photoreceivers , each photoreceiver being arranged to detect a fluorescent response from a respective biomarker, wherein each photoreceiver has an input filter arranged to remove frequencies outside an expected frequency range associated with the fluorescent response of its respective biomarker.
  • the photodetector module may be arranged to detect autofluorescent responses from NADH and FAD.
  • the analysis module may be arranged to calculate a tissue redox ratio based on the detected autofluorescent responses for NADH and FAD.
  • the device may include a display or indicator for outputting data from the processing module or analysis module.
  • the display may include a screen for providing a graphic illustrative of a parameter determined by the
  • the analysis module may be arranged to compare a determined value or values of the one or more microcirculation parameters with stored values indicative of normal or abnormal conditions in order to generate a diagnostic output.
  • the indicator may be arranged as a simple set of laser diodes/LEDs or the like which provide an indication of the nature of the diagnostic output .
  • the device discussed above may be embodiment in any suitable form. However, it is preferably incorporated into a wearable health monitor.
  • the wearable health monitor may comprise a housing containing the device set out above and a means for holding the housing on the human body. Any suitable strap or clip may be used for this purpose.
  • the components of the device may be distributed between the wearable housing and a remote computer.
  • the processing of the first and second signals need not occur within the wearable unit.
  • the processing module and analysis module discussed above may be embodied in an app or other software running on the remote computer.
  • a health monitoring apparatus comprising a wearable health monitor communicatively coupled to a remote computer, wherein the wearable health monitor comprises: a housing containing: a source of infrared radiation arranged to emit an infrared illumination pattern onto biological tissue
  • the remote computer comprises: a processing module arranged to analyse the first signal and the second signal to independently determine: a first Doppler shift associated with the first signal, the first Doppler shift being indicative of red blood cell (RBC) flow velocity in the biological tissue, and a second Doppler shift
  • the second Doppler shift being indicative of lymph contrast object flow velocity in the biological tissue.
  • the remote computer may comprise an analysis module such as that discussed above arranged to determine one or more microcirculation parameters based on the first Doppler shift and the second Doppler shift.
  • the wearable health monitor may further include a source of ultraviolet radiation arranged to emit an ultraviolet illumination pattern onto the biological tissue associated with a subject.
  • the photodetector module may be arranged to detect a fluorescent response from the biological tissue triggered by the ultraviolet illumination pattern.
  • the remote computer may be any device with suitable processing power, e.g. a smartphone, tablet computer, laptop computer or PC.
  • Fig. 1 is a schematic view of a wearable monitoring device that is an embodiment of the invention
  • Fig. 2 is a schematic view of the internal components of the monitoring device shown in Fig. 1 ;
  • Fig. 3 is a schematic diagram illustrating steps in a process for simultaneously determining flow information for red blood cells (RBC) and lymph contrast objects in a
  • Fig. 4 is a schematic diagram illustrating steps in a process for determining biomarker information from a subject's tissue at the same time as determining flow information for red blood cells (RBC) and/or lymph contrast objects in a subject's blood, which process can be performed by the monitoring device shown in Figs. 1 and 2.
  • RBC red blood cells
  • Figs. 1 and 2 DETAILED DESCRIPTION; FURTHER OPTIONS AND PREFERENCES
  • the present invention relates to a monitoring device for sensing properties of a subject's tissue, and in particular their blood flow.
  • the monitoring device itself may take any suitable physical form. For example, it may be a standalone benchtop or laboratory-based piece of equipment. However, it may also be embodied as a wearable device 100, as shown in Fig. 1, suitable for mounting on a limb 102 of a subject, e.g. the wrist or leg.
  • the wearable device 100 comprises a main body 104 and a strap 106 for securing the main body in contact with the subject's skin.
  • the underside of the main body 104 may comprises a window for transmitting probing radiation and for receiving measurement signals.
  • the upper side of the main body may have a display or a set of indicators 108 associated with it or mounted on it.
  • the display or set of indicators may be arranged to convey information about a current
  • the device may be arranged to transmit the information to a remote device, e.g. smartphone, tablet computer, laptop, PC or any other network-enabled computing device.
  • a remote device e.g. smartphone, tablet computer, laptop, PC or any other network-enabled computing device.
  • Any suitable wireless communication protocol may be used for this purpose, e.g. Bluetooth®, WiFi, etc .
  • the monitoring device 100 may resemble in size a
  • Fig. 2 is a schematic view of the main body 104.
  • the main body may define a hollow housing for retaining a
  • the plurality of components include a power source 110, e.g. a rechargeable battery or the like together with a controller for voltage stabilization and control of charging and discharging the battery.
  • the power source 110 can provide power for an illumination system, an optical detector, a processor, an output display, and a communications module.
  • the illumination system is a laser system 112 capable of generating an infrared (IR) output 114 and a ultraviolet (UV) output 116.
  • An output optical system 118 e.g. comprising one or more suitable lenses and/or a transparent window, may be disposed on the underside of the main body 104 to permit the optical radiation from each of the IR output 114 and UV output 116 to exit from the housing, e.g. to illuminate a patch of skin on a subject.
  • the IR output 114 may be arranged in conjunction with the output optics 118 to emit an illumination pattern suitable for performing Doppler flowmetry.
  • the IR output 114 may comprises a pair of radiation beam that intersect to form an interference pattern outside the main body 104, e.g. on the illuminated patch of skin.
  • the IR output 114 may be arranged to emit optical radiation at a single wavelength, e.g. in the range 800 nm to 1100 nm.
  • the IR output 114 may consist of a single frequency laser diode for this purpose.
  • the UV output 116 may be arranged in conjunction with the output optics 118 to emit a beam of UV radiation to illuminate the same or a different patch of tissue.
  • the UV output may consist of a single frequency laser diode selected to emit radiation at a wavelength that will excite fluorescent effects of biomarkers in the tissue.
  • the laser diode may emit optical radiation having a wavelength of 365 nm.
  • the laser system 112 may include a laser controller (not shown) arranged to control the irradiation power of the IR output 114 and/or UV output, e.g. via a control signal from a processing module 124.
  • a Peltier thermoelectric cooler can be used to control temperature of the laser diodes, if necessary.
  • the optical detector comprises a photodetector module 122 which contains one or more
  • the underside of the main body 104 include input optical system 120, e.g.
  • the photodetector module 122 comprises a suitable array of lenses and/or a transparent window for directing an optical signal incident on the underside of the main body into the photodetector module 122.
  • the input and output optical systems 118 and 120 may share one or more components in order to save space.
  • the photodetector module 122 may comprise a pair of photodetectors for capturing a reflection of the IR
  • photodetectors are arranged to convert the captured image into a pair of signals (e.g. electrical signals), which are used respectively to determine information relates to RBC flow and lymph contrast object flow, as discussed below.
  • signals e.g. electrical signals
  • the photodetector module 122 also comprises one or more filtered optical receivers for detecting specific types of fluorescent excitation radiation in the optical signal received back from the illuminated tissue.
  • filtered optical receiver may mean a suitable semiconductor optical sensor having a optical filter over its detection region to limit the range of wavelengths that it receives.
  • the filters used may be narrowband, to transmit only a certain band of wavelengths corresponding to an expected fluorescence effect.
  • the filters may act to prevent reflected UV or IR radiation from being detected.
  • the photodetector module 122 may comprises filtered optical receivers arranged to sense nicotinamide adenine dinucleotide (NADH) and Flavin-adenine- dinucleotide (FAD) autofluorescence excitation signals.
  • NADH nicotinamide adenine dinucleotide
  • FAD Flavin-adenine- dinucleotide
  • the processor comprises a processing module 124 which acts to control the laser system 112 and photodetector module 120.
  • the processing module 124 comprises a set of analysis submodules that are arranged to process signals from the photodetector module 122 to determine information about the illuminated tissue.
  • the analysis submodules are within the main body 104.
  • one or more or all of these submodules may be located in a remote device (e.g.
  • the processing module 124 may control a communication interface to transmit the signals received from the photodetector module to the remote device for further analysis.
  • a fluorescence detection module 126 there are three analysis submodules: a fluorescence detection module 126, a Doppler flowmetry module 128 and a microcirculation evaluation module 130.
  • the fluorescence detection module 126 is arranged to receive one or more signals from the filtered optical
  • the fluorescence detection module 126 may be arranged to assess skin NADH and FAD fluorescence from these signals in a conventional manner.
  • the fluorescence redox ratio may be calculated and output from the device, either via a display on the upper surface of the main body 104 or in a communication signal transmitted irelessly to a remote device.
  • the device is therefore operable as a wearable fluorimeter.
  • the Doppler flowmetry module 128 is arranged to analyse independently each signal from the pair of photodetectors to determine flow properties of RBC and lymph contrast objects respectively.
  • Each signal includes information indicative of variations in intensity of the illumination pattern caused by the flow of RBC or lymph contrast objects.
  • Each signal is filtered to remove frequencies that are outside the expected range of RBC of lymph contrast objects flow rates.
  • the signal for RBC detection is filtered to retain only frequencies that correspond to a flow rate of 0.1 to 4 mm/s, e.g. 250 Hz to 11 kHz. Similar filtering can be performed on the signal for lymph contrast object flow detection.
  • the target frequency band here may be different, e.g. 0 to 150 Hz. In some embodiments, the same filter may be used for both signals, e.g. having a band of 0 to 10 kHz.
  • the signal can be used to derive information about the flow rate of RBC or lymph contrast objects in the subject.
  • This information may be calculated and output from the device, either via a display on the upper surface of the main body 104 or in a communication signal transmitted wirelessly to a remote device.
  • the device is therefore operable as a wearable blood flowmeter that can simultaneously output flow rates of RBC and lymph contrast obj ects .
  • the filtered signals may be normalized by multiplying the output signal by an average RBC or lymph contrast object flow density, i.e. make the signal
  • the average RBC speed may be calculated based on a set of values of a RBC speed
  • microcirculation index e.g. by sampling this parameter at a frequency of 1 Hz or the like.
  • the microcirculation evaluation module 130 is arranged to extract further information from the filtered signals that are indicative of RBC and lymph contrast object flow rates. After normalizing the signal as discussed above, wavelet analysis of the whole spectrum is performed to determine one or more microcirculation rhythms. The wavelet analysis is sensitive to a drift around baseline value. To minimise it the averaged signals are normalised.
  • a myogenic rhythm (typically in the range 0.05 - 0.145 Hz) for the subject may be detected from either or both of the RBC spectrum and the lymph contrast object spectrum.
  • myogenic rhythm typically in the range 0.05 - 0.145 Hz
  • oscillations typically in the range 0.005 - 0.015 Hz
  • pacemaker oscillations typically in the range 0.016 - 0.042 Hz
  • breathing oscillations typically in the range 0.2 - 0.4 Hz
  • the calculated microcirculation rhythms may be compared with stored values that are indicative of various normal or abnormal conditions.
  • the stored values may be in a computer memory associated with the processing module 124.
  • the microcirculation evaluation module 130 may be arranged to output information indicative of a diagnostic condition.
  • condition information may be output from the device, either via a display on the upper surface of the main body 104 or in a communication signal transmitted wirelessly to a remote device.
  • the device is therefore operable as a diagnostic instrument for determined a current condition from RBC and lymph flow rate data.
  • the wavelet analysis may be performed periodically over a predetermined duration (e.g. 2 minutes), whereby values obtained for the calculated microcirculation rhythms are averaged over the duration before comparison with the stored values .
  • a predetermined duration e.g. 2 minutes
  • the main body 104 may include an indicator 132 for displaying the results of the various analysis processes performed by the processing module.
  • the diagnostics results are displayed using a three-colour LED indicator.
  • a green light may be used to correspond to normal conditions.
  • a yellow flashing light may be used to mean functional deviation from the normal which can be reversed.
  • a red flashing light may be used to mean deep and serious haemo- and lymph-dynamic deviation.
  • the indicator 132 may comprises a display screen for displaying a graphical user interface that shows the various calculated parameters.
  • the main body 104 may include a wireless module 134 for communicating with a remote device, e.g. to send and receive signals.
  • the wireless module 134 may be arranged to transmit the raw data from the photodetector module 122 or to transmit the calculated parameters from the processing module 124.
  • the wireless module 134 may receive software updates or values to store in the memory of the processing module .
  • Fig. 3 is a schematic flow that illustrates various steps in a method of operating the device discussed above, in particular to detect RBC and lymph perfusion data.
  • the method begins with a step 202 of irradiating the tissue with IR radiation as discussed above.
  • the method continues with a step 204 of detecting in a first detector (on a first channel for obtaining RBC flow data) a reflected signal of varying intensity.
  • the detected signal is filtered in step 206 to extract an RBC Doppler shift frequency band as discussed above.
  • this signal is used to determine an RBC flow velocity, which is output in step 218.
  • the filtered signal may be normalized in step 208 based on an average RBC flow density, as discussed above.
  • This normalized reflected signal is then subjected to wavelet analysis in step 210 to determine myogenic frequency.
  • the wavelet analysis may be performed on a set of reflected signals that are obtained over a measurement period (e.g. 2 minutes) .
  • the determined myogenic frequency may be an average of a plurality of values calculated during the measurement period.
  • a diagnostic condition is determined using the myogenic frequency. This can be done by compared the calculated myogenic frequency with stored values that
  • the method may conclude by instructing an indicator display configuration based on the determined diagnostic condition.
  • a similar process for lymph contrast objects can run in parallel.
  • method may include a step 220 of detecting in a second detector (on a second channel for obtaining lymph flow data) a reflected signal of varying intensity. The detected signal is filtered in step 222 to extract a lymph contrast object Doppler shift frequency band as discussed above .
  • this signal is used to determine a lymph contrast object flow velocity, which is output in step 228.
  • the filtered signal may be normalized in step 224 based on an average lymph contrast object flow density, as discussed above.
  • This normalized reflected signal is then subjected to wavelet analysis in step 210 to determine myogenic frequency or some other microcirculation parameter. As discussed above the wavelet analysis may be performed on a set of reflected signals that are obtained over a measurement period (e.g. 2 minutes) .
  • the determined microcirculation parameter may be an average of a plurality of values calculated during the measurement period.
  • Fig. 4 is a schematic flow that illustrates various steps in another method 300 of operating the device discussed above, in this case to simultaneously detect RBC and lymph perfusion data together with fluorescence data that permits
  • the method begins with a step 302 of irradiating the tissue separately or simultaneously with UV and IR radiation as discussed above.
  • the method continues with a step 304 of determining RBC and/or lymph contrast object flow information based on a reflected IR signal following one of more of the steps discussed with reference to Fig. 3 above) .
  • step 306 e.g.
  • the method includes a step 308 of detecting a fluorescence excitation signal from the region of irradiated tissue.
  • This step may be performed by one or more filtered photoreceivers as discussed above.
  • the detected fluorescence signal is filtered in step 310 in order to detect a specific biomarker.
  • NADH or FAD can be detected by selected the filters to leave the maximums corresponding to specific fluorescence peaks.
  • NADH and FAD may be detected simultaneously to permit determination of the tissue redox ratio.
  • the filtered signal is analysed to extract information relating to a detected biomarker.
  • This information is output in step 312, e.g. by being displayed on a screen or other indicator or by being transmitted to a remote device.

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Abstract

A monitoring device capable of non-invasive simultaneous detection of flow properties of both red blood cells (RBC) and lymph contrast objects using Doppler flowmetry. Measure a combination of both blood microcirculation and lymph microcirculation is advantageous because can provide richer diagnostic information. The device comprises an infrared radiation source, a photodetector module for detecting a first and second signals that corresponding respectively to portions of an infrared pattern reflected from the biological tissue. The signals are analysed to determine Doppler shifts indicative of RBC flow velocity and lymph contrast object flow velocity. The device may also function as a fluorimeter, i.e. to excite and detect autofluorescent signals from biomarkers in irradiated tissue.

Description

NON-INVASIVE HUMAN CONDITION MONITORING DEVICE
FIELD OF THE INVENTION
The invention relates to a device for monitoring a human condition non-invasively by monitoring an optical response of an illuminated region of tissue. In particular, the invention relates to a monitoring device, which may be wearable e.g. on a subject's wrist, that is suitable for simultaneous detection of red blood cell and lymph microcirculations. The monitoring device may also monitor metabolic biomarker fluorescence of the skin.
BACKGROUND TO THE INVENTION
It is widely recognised that the manner in which blood circulates through the human body reflects the health (both physiological and psychological) of that body. The advent of small scale blood flowmeters has enabled people more easily to measure their blood and lymph flows. It is known to provide wearable blood/lymph flow sensors which can communicate with a dedicated health or lifestyle app on a smartphone. It is know to use Doppler flowmetry in such devices to determine
information relating to the flow rate of blood/lymph. From this information, various properties of blood/lymph flow can be calculated or display.
US 7,130,672 discloses an apparatus for monitoring a plurality of tissue viability parameters. It includes two different illumination sources. A first illumination source is used to monitor blood/lymph flow rate, whilst a second illumination source is used to excite nicotinamide adenine dinucleotide (NADH) fluorescence.
SUMMARY OF THE INVENTION
At its most general, the present invention provides a monitoring device capable of non-invasive simultaneous detection of flow properties of both red blood cells (RBC) and lymph contrast objects using Doppler flowmetry. It is advantageous to measure both blood microcirculation and lymph microcirculation because the combination provides better (i.e. richer) diagnostic information. These two microflows in tissue are counterparts and work in opposite direction: blood brings solutions to tissue and lymph takes them away. For some cardiovascular disease conditions (e.g. heart failure, mechanical trauma, acute ischemic stroke, etc.), this balance between blood and lymph circulation is dramatically shifted towards dysfunction of the lymph flow.
The device may also function as a fluorimeter, i.e. to excite and detect autofluorescent signals from biomarkers in irradiated tissue.
According to a first aspect of the invention, there is provided a non-invasive human condition monitoring device comprising: a source of infrared radiation arranged to emit an infrared illumination pattern onto biological tissue
associated with a subject; a photodetector module for
detecting a first signal and a second signal, the first signal and the second signal corresponding to portions of the infrared illumination pattern that is reflected from the biological tissue; a processing module arranged to analyse the first signal and the second signal to independently determine: a first Doppler shift associated with the first signal, the first Doppler shift being indicative of red blood cell (RBC) flow velocity in the biological tissue, and a second Doppler shift associated with the second signal, the second Doppler shift being indicative of lymph contrast object flow velocity in the biological tissue. Thus, a common illumination source is used to obtain independent signals for RBC flow and lymph contrast object flow.
The source of infrared radiation may be arranged to output radiation at a single stable frequency. For example, the source of infrared radiation may be a laser diode. The infrared radiation may have a wavelength in the range 800 to 1100 nm.
The photodetector module may comprise a first
photodetector for detecting the first signal and a second photodetector for detecting the second signal . In other words, physically separate detectors may be provided to obtain the first signal and the second signal.
The processing module may be arranged to filter the first signal to remove frequencies outside an expected RBC Doppler shift frequency band. For example, the expected RBC Doppler shift frequency band may correspond to RBC flow rates in the range 0.1 to 4 mm/s . The expected RBC Doppler shift frequency band may be 250 to 11,000 Hz. Similarly, the processing module may be arranged to filter the second signal to remove frequencies outside an expected lymph contrast object Doppler shift frequency band. The expected lymph contrast object Doppler shift frequency band may be different from the expected RBC Doppler shift frequency band. For example, the expected lymph contrast object Doppler shift frequency band may be 0 to 150 Hz. Filtering the signal can remove unwanted noise and reduce the processing burden of subsequent analysis steps .
The device may include an analysis module arranged to determine one or more microcirculation parameters based on the first Doppler shift and the second Doppler shift. The analysis module may be arranged to perform wavelet analysis on the first signal and the second signal (preferably after the filtering discussed above) to extract information indicative of the one or more microcirculation parameters. The one or more microcirculation parameters can include any one or more of: myogenic, endothelial, neurogenic, breathing and pulse oscillations .
To provide a fluorimeter function, the device may include a source of ultraviolet radiation arranged to emit an
ultraviolet illumination pattern onto the biological tissue associated with a subject. The photodetector module may be arranged to detect a fluorescent response from the biological tissue triggered by the ultraviolet illumination pattern.
Preferably the photodetector module is arranged to detect a plurality of fluorescent responses, each of the plurality of fluorescent responses being associated with a respective biomarker. To achieve this, the photodetector module may comprise a plurality of photoreceivers , each photoreceiver being arranged to detect a fluorescent response from a respective biomarker, wherein each photoreceiver has an input filter arranged to remove frequencies outside an expected frequency range associated with the fluorescent response of its respective biomarker.
In an embodiment, the photodetector module may be arranged to detect autofluorescent responses from NADH and FAD. The analysis module may be arranged to calculate a tissue redox ratio based on the detected autofluorescent responses for NADH and FAD.
The device may include a display or indicator for outputting data from the processing module or analysis module. For example, the display may include a screen for providing a graphic illustrative of a parameter determined by the
processing module or analysis module. In one embodiment, the analysis module may be arranged to compare a determined value or values of the one or more microcirculation parameters with stored values indicative of normal or abnormal conditions in order to generate a diagnostic output. The indicator may be arranged as a simple set of laser diodes/LEDs or the like which provide an indication of the nature of the diagnostic output .
The device discussed above may be embodiment in any suitable form. However, it is preferably incorporated into a wearable health monitor. The wearable health monitor may comprise a housing containing the device set out above and a means for holding the housing on the human body. Any suitable strap or clip may be used for this purpose.
The components of the device may be distributed between the wearable housing and a remote computer. In particular, the processing of the first and second signals need not occur within the wearable unit. For example, the processing module and analysis module discussed above may be embodied in an app or other software running on the remote computer.
Thus, in another aspect of the invention there is provided a health monitoring apparatus comprising a wearable health monitor communicatively coupled to a remote computer, wherein the wearable health monitor comprises: a housing containing: a source of infrared radiation arranged to emit an infrared illumination pattern onto biological tissue
associated with a subject; a photodetector module for
detecting a first signal and a second signal, the first signal and the second signal corresponding to portions of the infrared illumination pattern that is reflected from the biological tissue; and a communication module for transmitting data relating to the first signal and the second signal to the remote computer, and wherein the remote computer comprises: a processing module arranged to analyse the first signal and the second signal to independently determine: a first Doppler shift associated with the first signal, the first Doppler shift being indicative of red blood cell (RBC) flow velocity in the biological tissue, and a second Doppler shift
associated with the second signal, the second Doppler shift being indicative of lymph contrast object flow velocity in the biological tissue.
The remote computer may comprise an analysis module such as that discussed above arranged to determine one or more microcirculation parameters based on the first Doppler shift and the second Doppler shift.
This distributed apparatus may also provide a fluorimeter function. Thus, the wearable health monitor may further include a source of ultraviolet radiation arranged to emit an ultraviolet illumination pattern onto the biological tissue associated with a subject. The photodetector module may be arranged to detect a fluorescent response from the biological tissue triggered by the ultraviolet illumination pattern.
The remote computer may be any device with suitable processing power, e.g. a smartphone, tablet computer, laptop computer or PC.
BRIEF DESCRIPTION OF THE DRAWINGS
An example of the invention is described in detail below with reference to the accompanying drawings, in which:
Fig. 1 is a schematic view of a wearable monitoring device that is an embodiment of the invention;
Fig. 2 is a schematic view of the internal components of the monitoring device shown in Fig. 1 ;
Fig. 3 is a schematic diagram illustrating steps in a process for simultaneously determining flow information for red blood cells (RBC) and lymph contrast objects in a
subject's blood, which can be performed by the monitoring device shown in Figs. 1 and 2; and
Fig. 4 is a schematic diagram illustrating steps in a process for determining biomarker information from a subject's tissue at the same time as determining flow information for red blood cells (RBC) and/or lymph contrast objects in a subject's blood, which process can be performed by the monitoring device shown in Figs. 1 and 2. DETAILED DESCRIPTION; FURTHER OPTIONS AND PREFERENCES
The present invention relates to a monitoring device for sensing properties of a subject's tissue, and in particular their blood flow. The monitoring device itself may take any suitable physical form. For example, it may be a standalone benchtop or laboratory-based piece of equipment. However, it may also be embodied as a wearable device 100, as shown in Fig. 1, suitable for mounting on a limb 102 of a subject, e.g. the wrist or leg. The wearable device 100 comprises a main body 104 and a strap 106 for securing the main body in contact with the subject's skin.
As explained below, the underside of the main body 104 may comprises a window for transmitting probing radiation and for receiving measurement signals. The upper side of the main body may have a display or a set of indicators 108 associated with it or mounted on it. The display or set of indicators may be arranged to convey information about a current
diagnostic state based on the received measurement signals. Alternatively or additionally, the device may be arranged to transmit the information to a remote device, e.g. smartphone, tablet computer, laptop, PC or any other network-enabled computing device. Any suitable wireless communication protocol may be used for this purpose, e.g. Bluetooth®, WiFi, etc .
The monitoring device 100 may resemble in size a
wristwatch or the like.
Fig. 2 is a schematic view of the main body 104. The main body may define a hollow housing for retaining a
plurality of components. The plurality of components include a power source 110, e.g. a rechargeable battery or the like together with a controller for voltage stabilization and control of charging and discharging the battery. The power source 110 can provide power for an illumination system, an optical detector, a processor, an output display, and a communications module.
In this example, the illumination system is a laser system 112 capable of generating an infrared (IR) output 114 and a ultraviolet (UV) output 116. An output optical system 118, e.g. comprising one or more suitable lenses and/or a transparent window, may be disposed on the underside of the main body 104 to permit the optical radiation from each of the IR output 114 and UV output 116 to exit from the housing, e.g. to illuminate a patch of skin on a subject.
The IR output 114 may be arranged in conjunction with the output optics 118 to emit an illumination pattern suitable for performing Doppler flowmetry. For example, the IR output 114 may comprises a pair of radiation beam that intersect to form an interference pattern outside the main body 104, e.g. on the illuminated patch of skin. The IR output 114 may be arranged to emit optical radiation at a single wavelength, e.g. in the range 800 nm to 1100 nm. The IR output 114 may consist of a single frequency laser diode for this purpose.
The UV output 116 may be arranged in conjunction with the output optics 118 to emit a beam of UV radiation to illuminate the same or a different patch of tissue. The UV output may consist of a single frequency laser diode selected to emit radiation at a wavelength that will excite fluorescent effects of biomarkers in the tissue. For example, the laser diode may emit optical radiation having a wavelength of 365 nm.
The laser system 112 may include a laser controller (not shown) arranged to control the irradiation power of the IR output 114 and/or UV output, e.g. via a control signal from a processing module 124. A Peltier thermoelectric cooler can be used to control temperature of the laser diodes, if necessary.
In this example, the optical detector comprises a photodetector module 122 which contains one or more
photodetectors or photoreceivers for sensing an optical signal received back from the illuminated tissue. The underside of the main body 104 include input optical system 120, e.g.
comprises a suitable array of lenses and/or a transparent window for directing an optical signal incident on the underside of the main body into the photodetector module 122.
The input and output optical systems 118 and 120 may share one or more components in order to save space.
The photodetector module 122 may comprise a pair of photodetectors for capturing a reflection of the IR
illumination pattern from the skin. The pair of
photodetectors are arranged to convert the captured image into a pair of signals (e.g. electrical signals), which are used respectively to determine information relates to RBC flow and lymph contrast object flow, as discussed below.
The photodetector module 122 also comprises one or more filtered optical receivers for detecting specific types of fluorescent excitation radiation in the optical signal received back from the illuminated tissue. Herein, "filtered optical receiver" may mean a suitable semiconductor optical sensor having a optical filter over its detection region to limit the range of wavelengths that it receives. The filters used may be narrowband, to transmit only a certain band of wavelengths corresponding to an expected fluorescence effect. The filters may act to prevent reflected UV or IR radiation from being detected. The photodetector module 122 may comprises filtered optical receivers arranged to sense nicotinamide adenine dinucleotide (NADH) and Flavin-adenine- dinucleotide (FAD) autofluorescence excitation signals.
In this example, the processor comprises a processing module 124 which acts to control the laser system 112 and photodetector module 120. The processing module 124 comprises a set of analysis submodules that are arranged to process signals from the photodetector module 122 to determine information about the illuminated tissue. In this embodiment, the analysis submodules are within the main body 104.
However, in other embodiment, one or more or all of these submodules may be located in a remote device (e.g. a
smartphone or the like) . In such an example, the processing module 124 may control a communication interface to transmit the signals received from the photodetector module to the remote device for further analysis.
In this example there are three analysis submodules: a fluorescence detection module 126, a Doppler flowmetry module 128 and a microcirculation evaluation module 130.
The fluorescence detection module 126 is arranged to receive one or more signals from the filtered optical
receivers in the photodetector module 122. The fluorescence detection module 126 may be arranged to assess skin NADH and FAD fluorescence from these signals in a conventional manner. The fluorescence redox ratio may be calculated and output from the device, either via a display on the upper surface of the main body 104 or in a communication signal transmitted irelessly to a remote device. The device is therefore operable as a wearable fluorimeter.
The Doppler flowmetry module 128 is arranged to analyse independently each signal from the pair of photodetectors to determine flow properties of RBC and lymph contrast objects respectively. Each signal includes information indicative of variations in intensity of the illumination pattern caused by the flow of RBC or lymph contrast objects. Each signal is filtered to remove frequencies that are outside the expected range of RBC of lymph contrast objects flow rates. For example, the signal for RBC detection is filtered to retain only frequencies that correspond to a flow rate of 0.1 to 4 mm/s, e.g. 250 Hz to 11 kHz. Similar filtering can be performed on the signal for lymph contrast object flow detection. The target frequency band here may be different, e.g. 0 to 150 Hz. In some embodiments, the same filter may be used for both signals, e.g. having a band of 0 to 10 kHz.
Following the filtering step, the signal can be used to derive information about the flow rate of RBC or lymph contrast objects in the subject. This information may be calculated and output from the device, either via a display on the upper surface of the main body 104 or in a communication signal transmitted wirelessly to a remote device. The device is therefore operable as a wearable blood flowmeter that can simultaneously output flow rates of RBC and lymph contrast obj ects .
In one embodiment, the filtered signals may be normalized by multiplying the output signal by an average RBC or lymph contrast object flow density, i.e. make the signal
proportionally correspondent to predetermined (e.g. previously calculated) number of the RBC or lymph contrast objects passing through illuminated tissue volume (typically 2-3 mm3) multiplied by an average RBC speed. The average RBC speed may be calculated based on a set of values of a RBC speed
microcirculation index, e.g. by sampling this parameter at a frequency of 1 Hz or the like.
The microcirculation evaluation module 130 is arranged to extract further information from the filtered signals that are indicative of RBC and lymph contrast object flow rates. After normalizing the signal as discussed above, wavelet analysis of the whole spectrum is performed to determine one or more microcirculation rhythms. The wavelet analysis is sensitive to a drift around baseline value. To minimise it the averaged signals are normalised.
For example, a myogenic rhythm (typically in the range 0.05 - 0.145 Hz) for the subject may be detected from either or both of the RBC spectrum and the lymph contrast object spectrum. By deriving myogenic rhythm from both RBS and lymph contrast objects spectra in parallel it is possible to obtain information about physiological regulatory events occurring simultaneously in opposite directions. A comparison of this information is of significant diagnostic value.
Other relevant microcirculations may also be detected. For example, it is possible to determine endothelial
oscillations (typically in the range 0.005 - 0.015 Hz), pacemaker oscillations (typically in the range 0.016 - 0.042 Hz), and breathing oscillations (typically in the range 0.2 - 0.4 Hz) .
The calculated microcirculation rhythms may be compared with stored values that are indicative of various normal or abnormal conditions. The stored values may be in a computer memory associated with the processing module 124. Depending on the results of this comparison, the microcirculation evaluation module 130 may be arranged to output information indicative of a diagnostic condition. The diagnostic
condition information may be output from the device, either via a display on the upper surface of the main body 104 or in a communication signal transmitted wirelessly to a remote device. The device is therefore operable as a diagnostic instrument for determined a current condition from RBC and lymph flow rate data.
The wavelet analysis may be performed periodically over a predetermined duration (e.g. 2 minutes), whereby values obtained for the calculated microcirculation rhythms are averaged over the duration before comparison with the stored values .
The main body 104 may include an indicator 132 for displaying the results of the various analysis processes performed by the processing module. In one embodiment, the diagnostics results are displayed using a three-colour LED indicator. A green light may be used to correspond to normal conditions. A yellow flashing light may be used to mean functional deviation from the normal which can be reversed. A red flashing light may be used to mean deep and serious haemo- and lymph-dynamic deviation.
Alternatively or additionally the indicator 132 may comprises a display screen for displaying a graphical user interface that shows the various calculated parameters.
The main body 104 may include a wireless module 134 for communicating with a remote device, e.g. to send and receive signals. For example, the wireless module 134 may be arranged to transmit the raw data from the photodetector module 122 or to transmit the calculated parameters from the processing module 124. The wireless module 134 may receive software updates or values to store in the memory of the processing module .
Fig. 3 is a schematic flow that illustrates various steps in a method of operating the device discussed above, in particular to detect RBC and lymph perfusion data.
The method begins with a step 202 of irradiating the tissue with IR radiation as discussed above. The method continues with a step 204 of detecting in a first detector (on a first channel for obtaining RBC flow data) a reflected signal of varying intensity. The detected signal is filtered in step 206 to extract an RBC Doppler shift frequency band as discussed above.
In step 216, this signal is used to determine an RBC flow velocity, which is output in step 218. The filtered signal may be normalized in step 208 based on an average RBC flow density, as discussed above. This normalized reflected signal is then subjected to wavelet analysis in step 210 to determine myogenic frequency. As discussed above the wavelet analysis may be performed on a set of reflected signals that are obtained over a measurement period (e.g. 2 minutes) . The determined myogenic frequency may be an average of a plurality of values calculated during the measurement period.
In step 212 a diagnostic condition is determined using the myogenic frequency. This can be done by compared the calculated myogenic frequency with stored values that
corresponding to normal and abnormal conditions. In step 214, the method may conclude by instructing an indicator display configuration based on the determined diagnostic condition. A similar process for lymph contrast objects can run in parallel. Thus method may include a step 220 of detecting in a second detector (on a second channel for obtaining lymph flow data) a reflected signal of varying intensity. The detected signal is filtered in step 222 to extract a lymph contrast object Doppler shift frequency band as discussed above .
In step 226, this signal is used to determine a lymph contrast object flow velocity, which is output in step 228. The filtered signal may be normalized in step 224 based on an average lymph contrast object flow density, as discussed above. This normalized reflected signal is then subjected to wavelet analysis in step 210 to determine myogenic frequency or some other microcirculation parameter. As discussed above the wavelet analysis may be performed on a set of reflected signals that are obtained over a measurement period (e.g. 2 minutes) . The determined microcirculation parameter may be an average of a plurality of values calculated during the measurement period.
Fig. 4 is a schematic flow that illustrates various steps in another method 300 of operating the device discussed above, in this case to simultaneously detect RBC and lymph perfusion data together with fluorescence data that permits
determination of tissue redox ratio.
The method begins with a step 302 of irradiating the tissue separately or simultaneously with UV and IR radiation as discussed above. The method continues with a step 304 of determining RBC and/or lymph contrast object flow information based on a reflected IR signal following one of more of the steps discussed with reference to Fig. 3 above) . The
determined information signal is output in step 306, e.g.
displayed on a screen or transmitted to a remote device.
In parallel with the determination of the RBC and/or lymph contrast object flow information, the method includes a step 308 of detecting a fluorescence excitation signal from the region of irradiated tissue. This step may be performed by one or more filtered photoreceivers as discussed above. The detected fluorescence signal is filtered in step 310 in order to detect a specific biomarker. For example, NADH or FAD can be detected by selected the filters to leave the maximums corresponding to specific fluorescence peaks. There may be two or more photodetectors having different filters for detecting different biomarkers. For example, NADH and FAD may be detected simultaneously to permit determination of the tissue redox ratio.
The filtered signal is analysed to extract information relating to a detected biomarker. This information is output in step 312, e.g. by being displayed on a screen or other indicator or by being transmitted to a remote device.

Claims

1. A non-invasive human condition monitoring device comprising :
a source of infrared radiation arranged to emit an infrared illumination pattern onto biological tissue
associated with a subject;
a photodetector module for detecting a first signal and a second signal, the first signal and the second signal
corresponding to portions of the infrared illumination pattern that is reflected from the biological tissue;
a processing module arranged to analyse the first signal and the second signal to independently determine:
a first Doppler shift associated with the first signal, the first Doppler shift being indicative of red blood cell (RBC) flow velocity in the biological tissue, and
a second Doppler shift associated with the second signal, the second Doppler shift being indicative of lymph contrast object flow velocity in the biological tissue.
2. The device of claim 1, wherein the source of infrared radiation is arranged to output radiation at a single stable frequency.
3. The device of claim 1 or, wherein infrared radiation has a wavelength in the range 800 to 1100 nm.
4. The device of any preceding claim, wherein the source of infrared radiation is a laser diode.
5. The device of any preceding claim, wherein the photodetector module comprises a first photodetector for detecting the first signal and a second photodetector for detecting the second signal .
6. The device of any preceding claim, wherein the processing module is arranged to filter the first signal t remove frequencies outside an expected RBC Doppler shift frequency band.
7. The device of claim 6, wherein the expected RBC Doppler shift frequency band corresponds to RBC flow rates in the range 0.1 to 4 mm/ s .
8. The device of any preceding claim, wherein the processing module is arranged to filter the second signal to remove frequencies outside an expected lymph contrast object Doppler shift frequency band.
9. The device of claim 6, wherein the processing module is arranged to filter the second signal to remove frequencies outside an expected lymph contrast object Doppler shift frequency band, and wherein the expected lymph contrast object Doppler shift frequency band is different from the expected RBC Doppler shift frequency band.
10. The device of any preceding claim including an analysis module arranged to determine one or more
microcirculation parameters based on the first Doppler shift and the second Doppler shift.
11. The device of claim 10, wherein the analysis module is arranged to perform wavelet analysis on the first signal and the second signal to extract information indicative of the one or more microcirculation parameters .
12. The device of claim 10 or 11, wherein the one or more microcirculation parameters including any one or more myogenic rhythm, endothelial oscillations, pacemaker
oscillations, and breathing oscillations.
13. The device of any preceding claim including a source of ultraviolet radiation arranged to emit an ultraviolet illumination pattern onto the biological tissue associated with a subject,
wherein the photodetector module is arranged to detect a fluorescent response from the biological tissue triggered by the ultraviolet illumination pattern.
14. The device of claim 13, wherein the photodetector module is arranged to detect a plurality of fluorescent responses, each of the plurality of fluorescent responses being associated with a respective biomarker.
15. The device of claim 14, wherein the photodetector module comprises a plurality of photoreceivers , each
photoreceiver being arranged to detect a fluorescent response from a respective biomarker, wherein each photoreceiver has an input filter arranged to remove frequencies outside an expected frequency range associated with the fluorescent response of its respective biomarker.
16. The device of claim 14 or 15, wherein the
photodetector module is arranged to detect autofluorescent responses from NADH and FAD, and wherein the device includes an analysis module arranged to calculate a tissue redox ratio based on the detected autofluorescent responses for NADH and FAD.
17. A wearable health monitor comprising:
a housing containing a non-invasive human condition monitoring device according to any preceding claim, and
means for holding the device on the human body.
18. A wearable health monitor according to claim wherein the means for holding the device is a strap.
19. A health monitoring apparatus comprising a wearable health monitor communicatively coupled to a remote computer, wherein the wearable health monitor comprises:
a housing containing:
a source of infrared radiation arranged to emit an infrared illumination pattern onto biological tissue
associated with a subject;
a photodetector module for detecting a first signal and a second signal, the first signal and the second signal corresponding to portions of the infrared illumination pattern that is reflected from the biological tissue; and
a communication module for transmitting data relating to the first signal and the second signal to the remote computer, and
wherein the remote computer comprises: a processing module arranged to analyse the first signal and the second signal to independently determine:
a first Doppler shift associated with the first signal, the first Doppler shift being indicative of red blood cell (RBC) flow velocity in the biological tissue, and a second Doppler shift associated with the second signal, the second Doppler shift being indicative of lymph contrast object flow velocity in the biological tissue.
20. The health monitoring apparatus of claim 19, wherein the remote computer comprises an analysis module arranged to determine one or more microcirculation parameters based on the first Doppler shift and the second Doppler shift.
21. The health monitoring apparatus of claim 19 or 20, wherein the wearable health monitor further includes a source of ultraviolet radiation arranged to emit an ultraviolet illumination pattern onto the biological tissue associated with a subject, and wherein the photodetector module is arranged to detect a fluorescent response from the biological tissue triggered by the ultraviolet illumination pattern.
22. The health monitoring apparatus of any one of claims 19 to 21, wherein the remote computer is a smartphone, tablet computer, laptop computer or PC.
PCT/EP2016/078707 2015-11-26 2016-11-24 Non-invasive human condition monitoring device WO2017089479A1 (en)

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