Method and system for measuring blood pressure

Abstract

A device and method for determining blood pressure are provided. In one example, a device for determining a subject's blood pressure includes a camera configured to measure a finger photoplethysmography (PPG) waveform, an accelerometer configured to measure a vertical height of the device relative to the subject's heart, an output device configured to guide the subject to raise his / her hand to change the transmural pressure of the artery while maintaining finger pressure on the camera, and a processor configured to calculate the subject's pulse pressure from the finger PPG waveform and the vertical height, and display the pulse pressure on a screen.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 135,430, filed January 8, 2021, which is incorporated herein by reference in its entirety.

[0002] High arterial blood pressure (BP) afflicts many people (e.g., approximately one in three adults worldwide). While incidence rates tend to increase with age, certain individuals may develop hypertension early in adulthood (e.g., approximately one in five U.S. adults under 40 years of age has hypertension). While symptoms may be asymptomatic, the risk of stroke and heart disease may increase monotonically with BP at a given age. Certain medications can reduce BP and cardiovascular risk. However, only three in seven hypertensive patients are aware of their condition, and one in seven individuals has their blood pressure controlled. Specific epidemiological data suggest that hypertension is emerging as a leading cause of years of life lost due to disability.

[0003] Certain auscultatory and oscillometric BP measurement devices can be used to manage hypertension. However, because these devices rely, at least in part, on an inflatable cuff, they may lead to lower rates of hypertension awareness and control. Cuff-based devices are not readily available, especially in low-resource settings. Therefore, it can be inconvenient for people to check their blood pressure regularly. Regular measurements during daily life are desirable to avoid the white coat and mask effect in clinics, where patients may present with higher or lower than normal blood pressure, and to average out large fluctuations in blood pressure that can occur over time due to, for example, stress, physical activity, and other factors. If blood pressure could be measured using more convenient devices, more people might be aware of their condition or motivated to take their medication.

[0004] Thus, an opportunity exists for methods and systems for measuring blood pressure using more convenient equipment. Summary of the Invention

[0005] The objects and advantages of the disclosed subject matter will be set forth in and apparent from the following description. Additionally, they may be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the devices particularly pointed out in the specification and claims, as well as from the accompanying drawings.

[0006] To achieve these and other advantages and in accordance with the objectives of the disclosed subject matter, the disclosed subject matter, as embodied and broadly described, provides a device and method for determining a subject's blood pressure. The device for measuring a subject's blood pressure can include a force sensor configured to measure finger pressure, a camera configured to measure a finger photoplethysmography (PPG) waveform, a screen configured to display a visual indicator configured to guide a subject to position the side of their finger on the camera and screen to target a finger artery and display the finger pressure in real time, thereby allowing the subject to evenly press their finger on the camera and screen to vary the external pressure of the artery, and a processor. The processor can be configured to construct an oscillogram that can be a function between variable amplitude blood volume oscillations and external finger pressure, calculate the subject's blood pressure from the oscillogram, and display the blood pressure on the screen. In a non-limiting embodiment, the processor can be configured to determine the visual indicator based on different finger placements on the camera and screen before performing a blood pressure measurement.

[0007] The disclosed subject matter provides a device for determining a subject's blood pressure, which may include: a skin contact area sensor configured to measure finger area; a camera configured to measure finger photoplethysmography (PPG) waveforms; a screen configured to display visual indicators on the camera and screen to guide the subject in positioning their fingertip to target the transverse palmar arch artery; and a processor configured to display finger pressure in real time to guide the subject in pressing their fingertip evenly on the camera and screen to vary the external pressure of the artery. The processor may be configured to convert finger area to finger pressure based on a predefined nomogram, construct an oscillogram that may be a function between variable amplitude blood volume oscillations and external finger pressure, calculate the subject's systolic and diastolic blood pressure from the oscillogram, and display the systolic and diastolic blood pressure on the screen.

[0008] As embodied herein, the nomogram may be configured to determine finger force from a finger area based on selected parameters of a parametric function and divide the determined finger force by the finger area to determine finger pressure. By way of example and not limitation, the selected parameters may be determined based on the subject's fingertip dimensions, a single cuff blood pressure measurement, or a hand-raising maneuver. As embodied herein, the subject may hold the device above heart level while pressing the finger, which may provide a more accurate nomogram. The processor may be configured to adjust the blood pressure measurement to heart level using the vertical height between the device and the subject's heart.

[0009] The disclosed subject matter provides a device for determining a subject's blood pressure, including: a camera configured to measure a finger photoplethysmography (PPG) waveform; an accelerometer configured to measure the vertical height of the device relative to the subject's heart; an output device configured to induce the subject to raise their hand while maintaining finger pressure on the camera to change arterial transmural pressure; and a processor. The processor can be configured to calculate the subject's pulse pressure from the finger PPG waveform and the vertical height and display the pulse pressure on a screen.

[0010] As embodied herein, the processor may be further configured to guide the subject to apply firm finger pressure against the camera, guide the subject to vary the level of finger pressure during the firm finger pressure based on the measured AC and / or DC values ​​of the PPG waveform and the PPG measurement value, and identify the finger pressure corresponding to when the blood volume oscillation is near a maximum. As embodied herein, the processor may be further configured to compare the PPG waveform during hand lift with the PPG waveform during finger pressing to assess the level of accuracy of the device.

[0011] As embodied herein, the processor may be configured to construct a shifted oscillogram to relate variable amplitude blood volume oscillations to hydrostatic pressure changes measured using vertical height. Pulse pressure can be calculated from the shifted oscillogram. As embodied herein, the accelerometer may be configured to measure the vertical height of the device relative to the heart. By way of example and not limitation, the processor may be configured to convert pulse pressure to brachial artery pulse pressure using a transfer function.

[0012] The disclosed subject matter provides a device for determining a subject's blood pressure. The device includes: a force sensor configured to measure the subject's finger pressure; a PPG sensor configured to measure the subject's finger PPG waveform; a barometric pressure sensor configured to measure the vertical height of the device relative to the subject's heart; and a processor. The processor may be configured to measure barometric pressure sensor readings while holding the device at heart level, during finger pressure and finger non-pressure, use the barometric pressure sensor readings to adjust the blood pressure measured during finger pressure to the heart level, and display the adjusted blood pressure of the subject on a screen. As embodied herein, blood pressure can be adjusted based on blood density, gravity, and / or the barometric pressure sensor reading.

[0013] The disclosed subject matter provides a device for determining a subject's blood pressure, comprising: a force sensor configured to measure fingertip pressure and fingertip vibrations; a visual indicator guiding the subject to position the fingertip on the force sensor; a screen configured to display fingertip pressure in real time and guide the subject to press the finger on the sensor to change external pressure in the underlying artery; and a processor. The processor may be configured to measure AC and DC components of the fingertip pressure, identify a maximally oscillating AC fingertip pulse and a maximally oscillating DC fingertip pulse, determine the subject's blood pressure based on the maximally oscillating AC fingertip pulse and the maximally oscillating DC fingertip pulse, and display the subject's blood pressure on the screen.

[0014] As embodied herein, the processor may be configured to determine blood pressure based on the subject's fingertip dimensions and / or the subject's single cuff blood pressure reading. As embodied herein, the processor may be further configured to calculate diastolic blood pressure from the variable amplitude acupressure pulse oscillations and systolic blood pressure from the blood pressure waveform.

[0015] As embodied herein, the blood pressure waveform is converted to a brachial artery blood pressure waveform using a transfer function and a regression equation. By way of example and not limitation, the device may further include a barometric pressure sensor for detecting blood pressure at the heart level.

[0016] The disclosed subject matter provides a device for determining a subject's blood pressure, comprising: an array of force sensors configured to measure finger pressure and finger pressure pulses across each sensing element of the array, a visual indicator for guiding a person to place the subject's fingertip on the sensor array, a screen configured to display finger pressure in real time and guide the subject to press the fingertip on the sensor to change external pressure in an underlying artery, and a processor. The processor may be configured to measure AC and DC components of finger pressure at each sensing element of the array, determine the subject's blood pressure from the AC and DC components, and display the subject's blood pressure on the screen.

[0017] As embodied herein, blood pressure can be determined based on the maximum pressure pulse oscillation on the sensing element and the DC component of finger pressure. By way of example and not limitation, the processor can be further configured to generate a finger blood pressure waveform based on the AC and DC components and convert the blood pressure waveform to a brachial artery blood pressure waveform using a transfer function and a regression model. As embodied herein, the device can further include an air pressure sensor for detecting blood pressure at the heart level.

[0018] The disclosed subject matter provides a device for determining a subject's blood pressure, including: a force sensor configured to measure finger pressure and finger pressure pulses; a finger photoplethysmography (PPG) sensor configured to measure a PPG waveform; a visual indicator to guide the subject in placing a fingertip on the sensor; a screen configured to display finger pressure in real time and guide the subject in pressing the fingertip on the sensor to change external pressure in an underlying artery; and a processor. The processor may be configured to measure AC and DC components of the finger pressure and PPG waveform, calculate an arterial compliance curve using the AC finger pressure component and the PPG waveform, calculate the subject's blood pressure using the arterial compliance curve, and display the subject's blood pressure on the screen.

[0019] As embodied herein, the processor may be further configured to calculate blood pressure by forming an oscillogram based on the external finger pressure and the PPG waveform, performing a cross-correlation between the arterial compliance curve and the derivative of the oscillogram with respect to pressure, and determining the minimum and maximum values ​​of the cross-correlation as the systolic blood pressure and the diastolic blood pressure. [Brief explanation of the drawings]

[0020] [Figure 1] 1A-1C are diagrams and graphs illustrating an exemplary oscillometric finger-pressure technique for cuffless and calibration-free monitoring of arterial blood pressure (BP) via a mobile device in accordance with the disclosed subject matter. [Figure 2A] 1 illustrates an exemplary smartphone-based device with a custom photoplethysmography (PPG) force sensor unit for implementing oscillometric acupressure techniques and a comparison of cuffless and cuff devices in accordance with the disclosed subject matter. [Figure 2B] 1 illustrates an exemplary smartphone-based device with a custom photoplethysmography (PPG) force sensor unit for implementing oscillometric acupressure techniques and a comparison of cuffless and cuff devices in accordance with the disclosed subject matter. [Figure 2] 1 illustrates an exemplary smartphone-based device with a custom photoplethysmography (PPG) force sensor unit for implementing oscillometric acupressure techniques and a comparison of cuffless and cuff devices in accordance with the disclosed subject matter. [Figure 3A] 10A-10C are photographs illustrating an exemplary mobile device application for implementing oscillometric finger pressure technology via PPG and force sensors in a smartphone in accordance with the disclosed subject matter. [Figure 3B] 10A-10C are photographs illustrating an exemplary mobile device application for implementing oscillometric finger pressure technology via PPG and force sensors in a smartphone in accordance with the disclosed subject matter. [Figure 3C] 10A-10C are photographs illustrating an exemplary mobile device application for implementing oscillometric finger pressure technology via PPG and force sensors in a smartphone in accordance with the disclosed subject matter. [Figure 4] 1 is a photograph showing an example of a technique for measuring BP from a finger artery using PPG and a 3D touch sensor in a smartphone according to the disclosed subject matter. [Figure 5] 1 is a graph illustrating an exemplary volume clamping technique for measuring BP waveforms via a finger cuff-PPG device in accordance with the disclosed subject matter. [Figure 6] 10A-10C illustrate exemplary techniques for measuring pulse pressure using a standard smartphone without 3D touch capabilities in accordance with the disclosed subject matter. [Figure 7] 10 is a chart illustrating an exemplary method of calculating finger force from finger screen contact area measurements and measuring systolic BP and diastolic BP via oscillometric acupressure and a standard smartphone in accordance with the disclosed subject matter. [Figure 8] 1 is a chart showing finger pressure measurements versus time during finger pressure in accordance with the disclosed subject matter. [Figure 9] FIG. 1 illustrates an exemplary finger pressure technique with pressure sensors based solely on applanation tonometry technology in accordance with the disclosed subject matter. [Figure 10] FIG. 1 illustrates an exemplary method for calculating BP utilizing AC components of both PPG and pressure measurements in conjunction with a physiological model in accordance with the disclosed subject matter. [Figure 11] 1A-1C illustrate an exemplary method for calculating venous blood pressure (VP) from the DC component of a finger PPG waveform during changes in finger transmural pressure, in accordance with the disclosed subject matter. [Figure 12] FIG. 10 illustrates an exemplary method of measuring VP via a volume clamp finger cuff-PPG device by varying the set point and detecting VP via counter-cuff pressure measurement in accordance with the disclosed subject matter. DETAILED DESCRIPTION OF THE INVENTION

[0021] Reference will now be made in detail to various exemplary embodiments of the disclosed subject matter, which are illustrated in the accompanying drawings.

[0022] The terms used herein generally have their ordinary meanings in the art, within the context of the disclosed subject matter and in the specific context in which each term is used. Particular terms are discussed below or elsewhere herein to provide further guidance to the practitioner in describing the compositions and methods of the disclosed subject matter.

[0023] As used herein, the use of the word "a" or "an," when used in conjunction with the term "comprising" in the claims and / or this specification, may mean "one," but is also consistent with the meanings of "one or more," "at least one," and "one or more," and further, the terms "having," "including," "containing," and "comprising" are interchangeable, and those skilled in the art will recognize that these terms are open-ended terms.

[0024] The term "about" or "approximately" refers to a range of acceptable error for a particular value as determined by those skilled in the art, which depends in part on how the value is measured or determined, i.e., the limitations of the measurement system. For example, "about" can mean within 3 or more standard deviations, according to the practice in the art. Alternatively, "about" can mean within 20%, preferably within 10%, more preferably within 5%, and even more preferably within 1% of a given value. Alternatively, particularly with respect to biological systems or processes, this term can refer to a value within a certain factor, preferably within 5-fold, and more preferably within 2-fold.

[0025] A "user" or "subject" herein is a vertebrate, e.g., a human or a non-human animal, e.g., a mammal. Mammals include, but are not limited to, humans, primates, farm animals, sport animals, rodents, and pets.

[0026] The disclosed subject matter provides techniques for determining a subject's blood pressure. The disclosed subject matter provides systems and methods for determining a subject's blood pressure using a non-invasive cuffless device. The non-invasive cuffless device embodied herein can be configured as a stand-alone medical device using dedicated hardware and / or software as described herein, or can be configured as or utilize a portable device. Additionally or alternatively, the non-invasive cuffless device can utilize a general-purpose mobile or wearable device, such as a smartphone, portable computer, or other suitable general-purpose device. An exemplary non-invasive cuffless device 100 can have a camera 304, a sensor 101, a screen 102, and a processor.

[0027] As embodied herein, and as shown, for example, in FIG. 1 , the screen 102 can be used to display visual indicators to guide the subject to position their finger (e.g., the side of their finger) on the camera and screen (e.g., targeting measurements from a finger artery and displaying finger pressure in real time so that the subject can press their finger evenly on the camera and screen to vary the external pressure of the artery). Additionally or alternatively, other output devices can be used to guide the subject, as described herein. Such output devices can include visual output devices, such as the screen 102 or other visual devices, configured to provide visual indicators, animations, text, or other visual signals to guide the subject, as described herein. Additionally, or as a further alternative, the output device can include a speaker or other audio device configured to provide audio indicators, spoken text or instructions, or other audio signals to guide the subject, as described herein.

[0028] For example, as embodied herein, device 100 can provide a one-time or periodic initialization to determine an optimal finger placement for a user. During this initialization, the user is guided to incrementally place more fingers on the screen. Device 100 can identify finger positioning that provides an adequate area of ​​screen contact without approaching force saturation. For example, but not by way of limitation, device 100 can provide visual indicators that can guide the user to position the fingers that can provide the maximum area of ​​screen contact without force saturation.

[0029] As embodied herein, the disclosed device 200 can include a force sensor 101. The force sensor can measure the pressure of a finger against the force sensor. For example, without limitation, referring to FIG. 2, the force sensor 201 can be connected to a plethysmography (PPG) sensor 202 to measure both the subject's finger pressure and the PPG waveform. As embodied herein, the force sensor can be located under a screen (e.g., a 3D touch sensor). For example, as shown in FIG. 3, a user can press a finger 301 against a screen 302, and a force sensor 303 under the screen 302 can measure the applied force to determine blood pressure. The screen can be configured to display finger pressure in real time to guide the subject to press evenly against the sensor to change the external pressure of the artery.

[0030] With further reference to FIG. 3 , as embodied herein, the camera 304 may be configured to measure a finger photoplethysmography (PPG) waveform. For example, a user may press a finger evenly onto the camera and screen (e.g., starting at 30 mmHg and approaching 180 mmHg), and the camera may measure the user's PPG waveform. With reference to FIG. 4 , for example, but not by way of limitation, the side of the finger 401 may be pressed against the camera to obtain a PPG waveform. As embodied herein, other components of the device 400 may be used simultaneously to improve the accuracy of the device 400. For example, by evenly pressing the side of the finger against the front camera and screen, both PPG and force measurements may be obtained with improved accuracy.

[0031] As implemented herein, the device 100 may include a processor. The processor may be configured to generate an oscillogram based on the measured PPG waveform and finger pressure. For example, the oscillogram may be a function 105 between variable amplitude blood volume oscillations and external finger pressure. The variable amplitude blood volume oscillations may be derived from the PPG waveform when a user presses a finger on a sensor to change the external pressure of the underlying artery. The processor may determine blood pressure from the oscillogram and display the determined blood pressure on a screen. For example, the processor may estimate systolic and diastolic blood pressure from the oscillogram using a standard fixed ratio algorithm, a patient-specific algorithm, or another suitable oscillometric BP estimation algorithm. Additionally or alternatively, mean blood pressure may be estimated using similar techniques.

[0032] Alternatively, the processor can estimate pulse pressure (e.g., PP = systolic blood pressure - diastolic blood pressure) based on a PPG waveform, which can be acquired through a PPG sensor (e.g., a camera or finger PPG sensor) without using a force sensor. The finger PPG waveform can include an alternating current (AC) component and a direct current (DC) component during an increase in external finger pressure. For example, the processor can use the DC and / or AC components of the PPG waveform to determine how much finger pressure the user needs to apply to the PPG sensor (e.g., a camera or finger PPG sensor). For example, as shown in FIG. 6 , the user can first press hard on the PPG sensor to determine a maximum DC value based on the user input. The device 100 can display a graph for recording DC values ​​versus time, and the y-axis range can be set by the identified maximum DC level. The processor can determine the DC level at which the AC vibration amplitude is greatest, which can correspond to the average BP, and can display a fixed target line to guide the user to substantially achieve this level of contact pressure. By way of example and not limitation, as shown in FIG. 6 , while maintaining this substantially constant finger pressure, a user can lower the device 600 downward 601 to the floor, with the device 600 facing upward 602 (or vice versa), and then slowly raise the device 600 above their head. The hand-raising act can be performed in a continuous motion (e.g., over 20-40 seconds) or in stages (e.g., approximately 30 degrees over 3-5 seconds, at times guided by a smartphone via audio cues). The device 600 can have an accelerometer / gyroscope for measuring internal hydrostatic pressure changes. Based on the acquired values, a processor can generate a function between variable amplitude blood volume oscillations and hydrostatic pressure changes. As embodied herein, the function can be a shifted oscillogram. PP can be calculated from the width of the oscillogram using a fixed ratio algorithm or another similar algorithm. By way of example and not limitation, the shifted oscillogram can be configured to relate variable amplitude blood volume oscillations to hydrostatic pressure changes measured using vertical height.For example, the user may be instructed to hold the device 600 in a predetermined position and orientation so that one axis of the accelerometer can be used to determine the vertical height relative to the heart. For example, as embodied herein, the top of the phone faces upward when the phone is fully raised above the head and faces downward when the phone is fully lowered. In this case, the phone's up / down accelerometer can be used to determine the vertical height relative to the heart. Alternatively, hydrostatic BP change can be estimated without using an accelerometer / gyroscope or any other sensor. While maintaining substantially constant finger pressure, the user can lower the device 600 downward 601 to the floor and then raise the device 600 above their head in intuitive and fixed increments (e.g., approximately 45 degrees for 3-5 seconds at a time, guided by the smartphone via audio cues). Hydrostatic BP change can then be estimated based on the known increments. The advantage here is that the device 600 does not need to be held in any predetermined position, and therefore, it may be easier to maintain constant finger pressure while raising the hand. As embodied herein, the disclosed device 100 can perform quality assessment, for example, the processor can assess the quality of the blood pressure measurement by comparing the PPG waveform during hand lift with the PPG waveform during finger press.

[0033] As embodied herein, a processor can convert finger BP measurements to brachial artery BP. For example, to obtain brachial blood pressure, the processor can extract the PPG waveform beat with the largest oscillation. The PPG waveform beats can then be calibrated so that their minimum and maximum correspond to the calculated finger diastolic and systolic BP. A transfer function accounting for wave reflection and a regression model accounting for resistive pressure drop can be applied to convert the finger waveform beats to brachial BP waveform beats. The minimum and maximum of the brachial blood pressure waveform beats can be defined as the systolic and diastolic blood pressures. Finger PP can be converted to brachial artery PP in a similar manner, but without using a regression model.

[0034] As embodied herein, the device 100 can include a skin contact area sensor, and the processor can be configured to measure systolic and diastolic blood pressure using the skin contact area sensor. The processor can convert the measured finger area into finger pressure using a predetermined nomogram. The nomogram can include a parametric function (e.g., an exponential function) for predicting finger force / pressure from the finger area. The processor can determine the parameters of this function by using an empirical equation with fingertip dimensions as input and the parameter(s) as output, and / or by using two finger pressure measurements at two different heights relative to the heart for known blood pressure changes or a single cuff blood pressure measurement. The empirical equation can be derived from a training dataset from a cohort of subjects. Finger pressure can be obtained by calculating force from the area measurement via a parametric function and dividing this value by the measured area. By way of example and not limitation, a user can hold the device 100 above heart level to improve the accuracy of the device 100. For example, a user can lie down and hold device 100 facing up with their arm straight while performing finger press actuation. As embodied herein, the calculated blood pressure can be adjusted for hydrostatic pressure changes using arm length.

[0035] As embodied herein, the device 100 can have a barometric pressure sensor for detecting BP at heart level. For example, the barometric pressure sensor can detect an elevation difference of less than about 5 cm, corresponding to a small error in blood pressure (e.g., an error of less than about 3.5 mmHg). A user can hold the device 100 with the barometric pressure sensor at heart level with one hand held against the chest for approximately 5 to 20 seconds. The barometric pressure measurements can be averaged. A user can measure blood pressure by performing acupressure techniques as described herein while holding the smartphone in any manner, including statically and at any vertical level relative to the heart. By way of example and not limitation, the barometric pressure can be averaged over finger actuations. The difference between the two measurements can provide a vertical height for correcting the blood pressure measurement for hydrostatic BP differential. As embodied herein, the blood pressure measurement can be corrected to heart level based on blood density, gravity, and the barometric pressure sensor reading. For example, a value of rho-gh (rho is a known blood density, g is gravity, and h is the second barometric pressure sensor reading minus the first barometric pressure sensor reading) can be added to the blood pressure measurement to correct it to cardiac level. By way of example and not limitation, the disclosed device 100 can have a temperature sensor that can be used to assess the quality of the PPG and barometric pressure measurements.

[0036] As embodied herein, a barometric pressure sensor can be used instead of or in addition to an accelerometer to determine the vertical height of the disclosed device 100 relative to the heart during hand-raising techniques 601, 602.

[0037] As embodied herein, the disclosed device 100 can determine a user's / subject's blood pressure using only a pressure sensor. For example, a user can press a force sensor of the device 100 on an artery. By way of example and not limitation, the disclosed device 100 can include a force sensor of known area. For example, a user can perform a finger press as described herein, and consistent with conventional applanation tonometry principles, the AC pressure waveform can increase with decreasing wall tension and then decrease with arterial occlusion. The AC waveform pulsation at maximum amplitude can correspond to a zero mean blood pressure waveform pulsation (ΔP(t)) scaled by an unknown constant that can be related to the area of ​​the artery divided by the area of ​​the sensor (k). The mean blood pressure (P_m) can be given by the DC pressure at which the AC amplitude is greatest according to applanation tonometry. A processor can generate a waveform indicative of kΔP(t)+P_m based on the measurements. The parameter k can be determined to have a fully defined finger blood pressure waveform pulsation. By way of example and not limitation, the parameter k can be determined via an empirical equation relating arterial area to fingertip dimension or by calibration with a single cuff blood pressure measurement. As embodied herein, the parameter k can be determined based on the diastolic blood pressure (P_d) measured from the AC pressure waveform. The minimum value of ΔP(t) can be scaled to equal P_d-P_m, and P_m can be added to the waveform to generate the finger BP waveform. The peak of the waveform is, for example, the systolic blood pressure (P_s).

[0038] As embodied herein, the disclosed device 200 can measure finger blood pressure using tonometry finger pressure. According to the applanation tonometry principle, a force sensor can flatten or applanate an artery so that wall tension is perpendicular to the force sensor and can be encompassed by the flattened artery, allowing pressure to be derived as a ratio of the measured force to a known sensor area. For example, the disclosed device 200 can include a multi-sensor force array. The multi-sensor array can be attached to the back of the device 200 (e.g., a mobile device or smartphone). A user can perform a finger-pressing actuation, and a maximum force oscillation pulses above the finger pressure and can be detected by all sensors. This pulse can be divided by the sensor element area to generate a finger BP waveform pulse. By way of example and not limitation, the sensor array can include sensing elements that can be smaller than the entire sensor. Therefore, smaller sensing elements are suitable for use in the sensor array without requiring high resolution.

[0039] As embodied herein, the disclosed device 100 can utilize both a force sensor and a PPG sensor to improve the accuracy of blood pressure calculations. The PPG sensor can be a camera or a finger PPG sensor. The processor can calculate systolic and diastolic blood pressure from the AC components of both the PPG and pressure measurements. For example, the processor can use an oscillometric model to calculate blood pressure based on the AC component of the PPG and the pressure measurements. The device 100 can have a PPG force sensor unit capable of detecting AC pressure waveforms. A user can perform a finger pressure method using the sensor unit as described herein. A maximum amplitude AC pressure waveform beat can be selected that can be concatenated to correspond to multiple PPG waveform beats. The derivative of the PPG waveform can be selected with respect to the concatenated pressure waveform and plotted against the DC pressure measurement to obtain data points representing a shifted arterial compliance curve. For example, a parameter function can be fitted to the data points, and the function can be shifted so that its peak is at zero transmural pressure to arrive at a scaled arterial compliance curve. By way of example and not limitation, blood pressure can be calculated by forming an oscillogram, taking its derivative with respect to external finger pressure, and performing a cross-correlation between the arterial compliance curve and the derivative of the oscillogram. The peak location of the cross-correlation function can represent diastolic BP, and the valley location can represent systolic BP. Alternatively, an oscillometric model with the compliance curve can be best-fit to the measured oscillogram or its derivative to estimate blood pressure.

[0040] example The following examples are offered only to illustrate and confirm the disclosed subject matter, but not to limit it.

[0041] background High arterial blood pressure (BP) affects approximately one in three adults worldwide. While incidence increases with age, many people develop hypertension in early adulthood (e.g., more than one in five American adults under age 40 have hypertension). Although the condition is usually asymptomatic, the risk of stroke and heart disease increases monotonically with blood pressure at a given age. Lifestyle changes and many inexpensive, once-daily medications can reduce blood pressure and cardiovascular risk. However, only three in seven people with hypertension are aware of their condition, and only one in seven controls their blood pressure. Epidemiological data on hypertension in low-resource settings are more alarming. Consequently, hypertension has emerged as a leading cause of years of life lost due to disability.

[0042] Auscultatory and oscillometric BP measurement devices have helped manage hypertension. At the same time, these devices rely on inflatable cuffs, which can be a liability for the recognition and control rate of severe hypertension. Cuff-based devices are not readily available, especially in low-resource settings. Therefore, most people do not check their blood pressure regularly. Regular measurement during daily life is necessary to avoid the white coat and mask effect in clinics, where patients present with higher or lower than normal blood pressure readings, and to average out large fluctuations in blood pressure that occur over time due to stress, physical activity, and other factors. More convenient access to blood pressure measurement could help more people become aware of their condition and motivate them to take their medications.

[0043] Therefore, there is a widespread demand for cuffless blood pressure monitoring devices. However, the devices under investigation generally suffer from the exhaustive limitation of requiring calibration with a cuff device to output measurements in mmHg.

[0044] Oscillometric principles have been extended to cuffless, calibration-free blood pressure monitoring via readily available smartphones. Figure 1 illustrates the concept. The user acts as the actuator by pressing their fingertip (instead of the cuff) against the phone to steadily increase external pressure in the underlying artery (held at heart level). Meanwhile, the phone, embedded with a basic photoplethysmography (PPG) and force transducer, acts as the sensor (rather than the cuff device) to measure the resulting variable-amplitude blood volume oscillations and applied finger pressure. The phone also provides visual feedback to guide finger actuation and, like the cuff device, applies an algorithm to calculate BP from the measurements. A video demonstration is available.

[0045] To implement this "oscillometric finger press method," we developed a device consisting of a custom PPG force sensor unit affixed to the back of a smartphone. This device can obtain BP measurements across the normal blood pressure range with a level of accuracy comparable to that of an FDA-cleared finger cuff volume clamp device. Figure 2 shows the device and accuracy results. The oscillometric finger press method can be implemented simply as an iPhone X application by utilizing the front camera as the PPG sensor and the sensitive strain gauge array ("3D Touch") under the screen as the force sensor. Figure 3 shows the app.

[0046] The technique for measuring blood pressure involves using a mobile device with PPG and force sensors and visual markings to indicate where to place the fingertip on the sensor unit, steadily varying fingertip pressure under smartphone guidance, forming an oscillogram (a function of variable-amplitude blood volume oscillations versus applied pressure), and calculating BP from the oscillogram. These techniques provided a convenient site for blood pressure measurement via finger pressure on the transverse palmar arch artery (see Figure 1).

[0047] The disclosed subject matter includes related improvements for further advancing blood pressure measurement. These improvements generally circumvent the prior art.

[0048] Improved app for smartphones with existing PPG and force sensors Many smartphones have 3D Touch functionality, including iPhone 6s-X models and select Huawei and Xiaomi models. In these phones, the front-facing camera for PPG sensing is located some distance (e.g., 2–8 mm) from the force sensor below the screen, and the base of the fingernail on the fingertip should be above the front-facing camera for high-fidelity measurement of blood volume oscillations. Therefore, only a small portion of the finger is above the force sensor below the screen, which degrades the force measurement, while small changes in finger force are interpreted as large changes in pressure (i.e., more difficult finger actuation). Conversely, placing a larger portion of the fingertip above the screen degrades the PPG measurement.

[0049] The disclosed subject matter provides technology configured to target the digital arteries running along the side of the finger to measure BP via PPG and 3D touch sensors already present in smartphones (see Figures 1-3). Figure 4 illustrates the concept of finger positioning. By uniformly pressing the side of the finger against the front camera and screen, both PPG and force measurements can be obtained with excellent accuracy. However, placing the finger too much on the screen can saturate the force measurement at lower pressures. A solution is to use a one-time or periodic initialization (see, for example, Figure 3B) to determine the optimal finger placement for a given user. During this initialization, the user incrementally places more fingers on the screen and performs the finger pressing method for each finger placement. The data is analyzed to determine the finger positioning that results in the largest area of ​​screen contact without approaching force saturation. Alternatively, or additionally, the phone can be held over the heart (e.g., at shoulder level), which reduces the finger BP and therefore reduces the possibility of premature saturation of the force sensor. The known or measured distance between heart level and shoulder level can then be used to correct the calculated BP for this "hydrostatic BP change" (see next section for details).

[0050] App for conventional smartphones without force sensors Considering that virtually all adults are at real risk of developing hypertension and that smartphones are available to billions of people, including those in low-resource environments, it would be desirable to have a standalone smartphone as a BP monitor. However, most smartphones do not have 3D Touch or similarly sensitive force sensors. Therefore, the disclosed subject matter provides techniques for measuring absolute BP in mmHg using only a standard smartphone.

[0051] One example uses arm rather than finger actuation. In oscillometry, a cuff compresses an artery, changing its external pressure. During this process, the device measures cuff pressure, which indicates both the blood volume oscillations within the artery (AC cuff pressure) and the external pressure (DC cuff pressure). BP is estimated from the resulting oscillogram, which is again a function relating the variable-amplitude blood volume oscillations to the applied pressure. Note that the abscissa of the oscillogram can be more generally viewed as the change in arterial transmural pressure (i.e., in this case, internal BP minus external cuff pressure). Therefore, certain methods involve changing the internal, rather than external, pressure of the artery to change transmural pressure. When a user of a finger-worn ring device straightens their arm and lowers their hand, the weight of the blood column in the arm (the "hydrostatic effect") causes the internal BP of the finger to increase by an amount equal to ρgh. ρ is the known blood density, g is gravity, and h is the vertical distance between the hand position and the heart. In this way, the arterial transmural pressure changes without the cuff. The device contains a PPG sensor, a force sensor, and an accelerometer. The accelerometer allows for measurement of hydrostatic BP changes (i.e., ρl g sin θ, where l is the measured arm length, θ is the angle between the arm and the horizontal plane, and g sin θ is the accelerometer output). Blood pressure changes over a typical arm length are approximately ±50 mmHg relative to heart level. For a mean blood pressure of 80 mmHg, transmural pressure fluctuations are approximately 30–130 mmHg. However, oscillograms in both positive and negative transmural pressure regimes are required to accurately calculate BP. Therefore, the ring must be worn firmly enough to generate negative transmural pressure. A force sensor of known area measures the ring contact pressure against the finger, which is subtracted from the hydrostatic BP change. BP can then be estimated from the PPG oscillations as a function of transmural pressure change. The main problem is that the ring should be applied with a pressure equal to or near mean blood pressure, which is what we are trying to measure.

[0052] Another issue with hand-lift activation on smartphones is that it eliminates the need for a force sensor. Note, however, that all smartphones have a PPG sensor in the form of a camera or a dedicated sensor (e.g., the Samsung Galaxy S series) and a 3-axis accelerometer / gyroscope combination.

[0053] To solve these and other problems, the disclosed subject matter can limit measurements to pulse pressure (PP = systolic BP - diastolic BP), which is useful for detecting isolated systolic hypertension, a common form of hypertension that occurs with aging.

[0054] To illustrate the overall idea, Figure 5 (left) shows the finger PPG waveform (AC and DC components) while increasing the external finger-cuff pressure. (Note that the PPG waveform is not inverted, as is typically done in practice.) The AC component increases and then decreases in amplitude, consistent with oscillometric principles, while the DC component rises to a maximum value. This maximum value varies over time for a given user.

[0055] Figure 6 shows exemplary steps for implementing the overall concept of measuring absolute PP using only a standard smartphone. The first step is to use the DC and / or AC components of the PPG waveform to determine how much finger contact pressure the user should apply to the smartphone PPG sensor. For example, the user first presses very hard on the PPG sensor to determine the maximum DC value. Next, the smartphone displays a graph recording the DC value versus time, with the y-axis range set by the maximum DC level. The graph also includes two target lines indicating how hard the user should press to reach the maximum DC level, for example, in 20–40 seconds. (The user can also slowly release finger pressure from the hard press, as shown in the figure.) The current DC level (e.g., averaged over several beats) is displayed in real time to guide finger actuation. The smartphone then finds the DC level near the maximum where the AC vibration amplitude corresponds to the average BP and displays a constant target line to guide the user in achieving this level of contact pressure. While maintaining this constant finger pressure, the user lowers the phone to the floor, pointing downward, and then slowly raises it above their head, pointing upward (or vice versa). The hand-raising actuation can be performed in a continuous motion (e.g., over 20–40 seconds) or in steps (e.g., approximately 30 degrees for 3–5 seconds when guided by the phone via an audio cue). A y-axis accelerometer / gyroscope is used to measure internal hydrostatic pressure changes. The function between the resulting variable-amplitude blood volume oscillations and hydrostatic pressure changes is a horizontally shifted oscillogram. Because finger contact pressure is not measured, the horizontal shift is unknown. Therefore, systolic and diastolic blood pressure cannot be calculated. However, PP can be calculated from the width of the oscillogram using a standard fixed-ratio algorithm or other methods. To verify that the user maintained contact pressure throughout the hand-raising actuation, the maximum oscillation can be compared to the initial maximum oscillation. If the two values ​​are substantially different, the user is prompted to try again.

[0056] Alternatively, hydrostatic BP change can be estimated without using an accelerometer / gyroscope or any other sensors. While maintaining constant finger pressure, the user lowers the phone to the floor and then raises it in intuitive and fixed increments (e.g., approximately 45 degrees for 3–5 seconds when guided by the smartphone via audio cues). Hydrostatic BP change can then be estimated based on the known increments. The advantage here is that the orientation of the phone, which can affect the use of an accelerometer / gyroscope, becomes less important, making it easier to raise the hand. Additionally, the initial step of determining constant finger pressure may not be necessary. The user can simply press firmly on the PPG sensor and raise their hand. If an inverted-U oscillogram is not observed, the phone can ask the user to try again or perform the initial step. As another alternative, a smartwatch (e.g., Apple Watch) with a PPG sensor for measuring PPG waveforms from the back of the wrist can be used instead. The initial step can be performed by tightening the watch. The same tightness of the watch can be used for subsequent blood pressure measurements.

[0057] Another example involves measuring systolic and diastolic BP via a standard smartphone by accurately measuring finger contact area using the existing capacitive sensor array under the screen in addition to the front-facing camera. As shown in Figure 7, a parametric function, such as an exponential function, can relate finger area to force. The one to three unknown parameters of this function can be determined in various ways for a given user. One method is to form an empirical equation using fingertip dimensions measured using the phone (e.g., see Figure 3B) as input and the parameters as output. Alternatively, or in addition, for a known BP change and / or single-cuff BP measurement, two finger pressure measurements at two different heights relative to the heart can be obtained, and the parameters can be determined so that the finger pressure method yields a BP value. Finger pressure can then be obtained by calculating force from the area measurement via a parametric function and dividing this value by the measured area. This function becomes less accurate at higher pressures, and small changes in area translate into large changes in pressure (see Figure 7). Therefore, a lower pressure range should be used preferentially (i.e., Figure 7 "ROI" or region of interest). One way to ensure a lower pressure range is for the user to hold the phone above heart level to lower blood pressure. For example, the user can lie down while performing finger pressure actuation, with arms straight and the phone facing upward. BP calculated via finger pressure can then be adjusted for hydrostatic BP changes using arm length.

[0058] For example, finger BP is measured. However, brachial BP is clinically important. Finger BP is approximately 10 mmHg lower than brachial BP due to resistive pressure drop. Finger PP is higher than brachial PP due to wave reflection, especially in more compliant arteries. Therefore, finger diastolic and mean blood pressures are lower than brachial diastolic and mean blood pressures, while finger systolic blood pressure fluctuates compared to brachial systolic blood pressure. To obtain brachial blood pressure, the PPG waveform beat with the largest oscillation is extracted. This beat is the best, but may not perfectly correspond to the finger BP waveform beat. The PPG waveform beat is then calibrated so that its minimum and maximum correspond to the calculated finger diastolic and systolic BP. Then, a transfer function (to account for wave reflection) and a regression equation (to account for resistive pressure drop) or other similar transformations are applied to convert the finger waveform beat to a brachial BP waveform beat. The minimum and maximum values ​​of the brachial blood pressure waveform beat are taken as the systolic and diastolic blood pressure. If only finger PP is available, the PPG waveform beat with the highest amplitude is calibrated so that its amplitude is equal to finger PP, and then a transfer function is applied to obtain a zero-mean brachial BP waveform. The peak-to-peak amplitude of this waveform gives the brachial PP.

[0059] A convenient sensor for measuring blood pressure at heart level Previous techniques have involved capturing images of the user to ensure BP measurements at heart level. However, such image processing can be challenging and not sufficiently accurate. The disclosed subject matter provides a technique for using highly sensitive barometric pressure sensors with increased sensitivity for hydrostatic BP correction. These sensors can detect elevation differences of <5 cm, corresponding to an error of only approximately <3.5 mmHg. Exemplary steps are as follows: A device similar to that shown in Figure 2 has been developed, which also includes a barometric pressure sensor. First, the user holds the phone at heart level in a "Pledge of Allegiance" pose for 5 to 20 seconds. The barometric pressure measurements are averaged. Next, the user performs acupressure to measure BP while holding the phone statically in any manner, including at any vertical level relative to the heart. The barometric pressure is averaged across finger movements. The difference between the two measurements provides the vertical height for correcting the BP measurement for hydrostatic BP discrepancy. The barometric pressure sensor can also be used in conjunction with a temperature sensor, which can be used to determine the quality of the PPG measurement, which is degraded by cold fingers and other factors.

[0060] Custom device with pressure sensor only PPG sensors, especially those using visible light, do not perform well in low-signal conditions such as cold environments (e.g., air-conditioned rooms) and dark skin. Using only pressure sensors capable of measuring pulse and pressure across the BP range (e.g., 0–250 mmHg) can overcome the limitations of PPG while simplifying sensor design or even providing greater accuracy in BP measurements. The disclosed subject matter can include performing acupressure using only pressure sensors based on the applanation tonometry principle. The general principle involves pressing a force sensor against an artery. In this example, the sensor must (i) flatten or “applanate” the artery so that wall tension is perpendicular to the sensor, and (ii) be surrounded by the flattened artery so that pressure can be derived as the ratio of measured force to the known sensor area.

[0061] A device similar to Figure 2 has been developed, but only includes a force sensor that detects the known area. The user performs a finger-pressure procedure. Figure 8 shows the resulting finger pressure as a function of time during the finger-pressure maneuver. The AC pressure waveform increases with decreasing wall tension and decreases with arterial occlusion. This pattern therefore resembles oscillometry. The AC waveform pulsation at maximum amplitude may correspond to the zero-mean BP waveform pulsation (ΔP(t)) scaled by a constant that may be related to the unknown area of ​​the artery divided by the area of ​​the sensor (k). The mean BP (P m ) can be given by the DC pressure at which the AC amplitude is maximum. Therefore, this process is given by kΔP(t)+P m The parameter k must be determined to have a fully defined finger BP waveform. This parameter can be determined in a variety of ways.

[0062] The parameter k can be determined via an empirical equation relating arterial area to fingertip dimensions (e.g., measured using a smartphone as shown in Figure 3B) or by calibration using single-cuff BP measurements. In either case, arterial area can be assumed to be constant for a given person.

[0063] Another method to determine the parameter is to measure diastolic BP (P) from the AC pressure waveform, as well as oscillometric algorithms such as fixed ratio algorithms. d ) is detected. Then, the minimum value of ΔP(t) is P d -P m is scaled to be equal to P m Adding this to the waveform gives the finger BP waveform, and the peak of this waveform is the systolic blood pressure (P s ) Systolic blood pressure is the most difficult to measure with an oscillometric algorithm.

[0064] Figure 9 shows a more accurate method for determining finger BP by tonometry finger pressure. A multi-sensor force array is attached to the back of a smartphone. Finger pressure actuation is performed. The maximum force vibration beat across all finger pressures and all sensors is detected. This beat is divided by the sensing element area to obtain the finger BP waveform beat. This method is algorithm-free, and it is the algorithm that limits the accuracy of oscillometric BP measurement. Additionally, because the sensing element is smaller than the entire sensor, the pressure pulse for measurement is larger (and corresponds to BP measured by applanation tonometry). As a result, each element does not need to be highly sensitive and can even have a resolution of approximately 1-2 mmHg in the range of 0-250 mmHg. If there is only one sensing element covering the same area, the maximum amplitude vibration may be only a few mmHg, and therefore the resolution must be approximately 0.1-0.2 mmHg in the same range. Each sensing element can cover an area of ​​0.5 square mm or less. This exemplary method can also be implemented using a mechanical control that automatically compresses the fingertip.

[0065] In all cases, the finger BP waveform can be converted to brachial BP and corrected to cardiac level as described in the previous section.

[0066] Accurate blood pressure calculation algorithm using PPG and pressure sensor Alternatively, a pressure sensor for measuring AC pressure waveforms and DC external pressure can be used in conjunction with a PPG sensor to improve the accuracy of BP calculations. As previously mentioned, oscillometric algorithms are a bottleneck in achieving clinical accuracy.

[0067] 10 shows PPG (AC component only) and pressure measurements during acupressure movements. The disclosed subject matter provides techniques for calculating systolic and diastolic BP from the AC components of both PPG and pressure measurements.

[0068] Similar to the exemplary method described in the previous section, one method is to calculate diastolic and mean BP from the oscillogram using a fixed ratio or another algorithm, find the AC pressure pulse with the largest amplitude, and scale it so that its minimum and average are equal to the diastolic and mean BP. Systolic BP is then given as the peak of the calibrated finger BP waveform.

[0069] Another method is to invoke a mathematical model of oscillometry. A useful oscillogram model is to express the vibration amplitude (ΔO) as a function of the SP and DP (P s and P d ) and expressed as the difference in the arterial blood volume-transmural pressure relationship (f(·)):

[0070]

number

[0071] P e is the external arterial pressure, and c is a scale factor to convert blood volume to PPG units. e By differentiating with respect to, we obtain the following model of the derivative of the oscillogram:

[0072]

number

[0073] g(·) is the derivative of f(·) and represents the arterial compliance curve. One exemplary parametric model for the compliance curve is as follows:

[0074]

number

[0075] where u(·) is a unit step function, α and β reflect the width of the arterial compliance curve across negative and positive transmural pressures, and γ indicates the height of the curve. This model can be fitted to the measured oscillogram alone to determine systolic and diastolic BP and arterial compliance parameters. Thus, in contrast to traditional oscillometric algorithms, this exemplary algorithm is person-specific in the sense that both BP and compliance are measured. However, estimating the five parameters from limited information in the oscillogram can be challenging.

[0076] Figure 10 also illustrates an improved technique that uses a model in conjunction with the AC component of the PPG and pressure measurements to calculate BP levels. A PPG force sensor unit similar to that shown in Figure 2 is employed. However, this force sensor contains only one sensing element sensitive enough to detect the AC pressure waveform. The user performs a finger-pressure technique using the sensor unit. The AC pressure waveform beat with the largest amplitude is selected to obtain kΔP(t). This beat is concatenated to correspond to multiple PPG waveform beats. To facilitate beat detection and alignment, ECG waveforms measured with dry electrodes on the same device can be utilized. The derivative of the PPG waveform is then taken with respect to the concatenated pressure waveform and plotted against the DC pressure measurement to generate data points representing a shifted arterial compliance curve, which is then divided by k. A parametric function is fitted to the data points, shifting the function so that its peak is at zero transmural pressure (see Equation (3)), to arrive at a scaled arterial compliance curve (i.e., g(·) / k). Either equation (1) or (2) into which this curve is substituted is best fitted to the measured oscillogram or its derivative to obtain a reduced number of parameters (P s , P d, k·c) is estimated. Alternatively, the cross-correlation function (possibly after some smoothing) between the compliance curve and the derivative of the oscillogram is taken. Consistent with equation (3), the location of the peak in the cross-correlation function represents diastolic BP, and the location of the valley represents systolic BP.

[0077] Mobile device for measuring venous blood pressure All of the above examples relate to arterial blood pressure (BP) measurements. However, venous blood pressure (VP) is also important. VP can be used to predict the onset of congestion-related symptoms in patients with heart failure (bilateral heart failure, right heart failure, or left heart failure resulting in high pulmonary afterload), thereby avoiding costly hospitalizations. VP can also be used to manage patients with pulmonary arterial hypertension. However, VP typically requires an invasive procedure for its measurement. The disclosed subject matter provides techniques for converting the above concepts to noninvasive measurement of VP.

[0078] One method is based on Figure 11, which shows the finger PPG waveform (AC+DC components) as a function of finger cuff pressure over the entire range of finger cuff pressure. (Here, the PPG waveform is inverted in contrast to Figure 5.) The plot shows an initial sharp drop in PPG amplitude followed by a common pattern in oscillometry. The two reference points of the sharp drop may indicate diastolic and systolic VP. Therefore, it is conceivable to vary the external pressure of the finger artery and measure the DC (and AC) components of the PPG waveform in addition to the force required to detect VP. However, it may be difficult for users to perform finger presses at very low contact pressures between 0 and 30 mmHg (corresponding to the VP range). Furthermore, at such low contact pressures, the finger contact area should also be measured, which increases significantly in this range (see Figure 7).

[0079] To achieve these and other advantages, the disclosed subject matter provides techniques for creating a finger-worn ring sensor that includes an infrared PPG transducer for finger artery measurements, a force sensor with a known contact area, and an accelerometer / gyroscope. The sensor may be attached to the finger with a Velcro® strap or belt-like latch. The length of the person's arm is measured to determine the difference in ρgh between when the hand is at heart level and when fully lowered. The ring is tightened by the user under audio or visual guidance from the device to approximately equal this value. A marker, such as a belt hole number, can be used to indicate the level of tightness for future use. The user then lowers their arm and slowly raises it to heart level, as previously described. Relative vertical height is measured using an accelerometer, as previously described. A plot of the DC and AC components of the PPG waveform versus hydrostatic BP change, minus the sensor's finger contact pressure (ranging from 0 mmHg to ρgh), is used to detect VP.

[0080] Another solution for standard smartphones is to use the front-facing camera and capacitive sensor array to measure the entire PPG waveform, finger contact area, and finger force, as described in the previous section. In this case, since VP is low, a useful ROI can be examined for a function relating area to force (see Figure 7) to calculate the force from the area. The user then presses their finger uniformly across the camera and screen, starting at 0 mmHg and approaching 40–50 mmHg, to generate a similar plot and detect VP. While finger pressure activation may not be easy, the device is readily available.

[0081] For both solutions, the AC component of the PPG can also be useful to detect VP: for example, the maximum oscillation during a dive can reflect the average VP.

[0082] Another exemplary method is based on the finger-cuff volume clamp principle, also shown in FIG. 5. The principle is based on the concept of arterial unloading. Arterial unloading is achieved when the external pressure of the blood vessel is set to the internal BP (i.e., zero transmural pressure). The blood volume in this unloaded state is not zero; rather, it is a significant fraction (e.g., half) of the normal state because arteries, unlike veins, are not contractible blood vessels. An integrated cuff-PPG device is placed around the finger, and the measured blood volume is clamped to the unloaded state by rapidly changing the cuff pressure through feedback (e.g., proportional-integral-derivative (PID) control as shown in FIG. 5). During systole and diastole, as the blood volume rises and falls relative to the unloaded blood volume, the cuff pressure is increased and decreased almost instantaneously to maintain the clamped blood volume at the unloaded blood volume (i.e., the set point). This set point is initially determined in an open-loop manner by slowly increasing the cuff pressure and activating an oscillometric algorithm. In this way, the cuff pressure can be equal to the finger BP waveform under closed-loop operation.

[0083] Figure 12 shows a range of possible PPG setpoints and the corresponding finger cuff pressure required to maintain each setpoint. The cuff pressure trace increases slowly with little pulsatility and then begins to increase with greater pulsatility as the setpoint is decreased. Lower setpoints are detected via an oscillometric algorithm and used to measure BP. However, cuff pressures at higher setpoints indicate VP. Therefore, an innovative concept is to create a finger cuff-PPG volume clamp device, vary the setpoint (e.g., over a higher range), and measure the cuff pressure required to maintain each setpoint. The initial plateau region can then be used as a measure of VP. VP can be more accurately detected by identifying cuff pressures that exhibit typical VP waveform characteristics (e.g., a, c, x, v, and / or y waves). This method is more complex but may be more accurate.

[0084] In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combinations of the dependent features claimed below and disclosed above. Thus, the specific features presented in the dependent claims and disclosed above can be combined with each other within the scope of the disclosed subject matter, and the disclosed subject matter should be recognized as specifically directed to other embodiments having any other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to the disclosed embodiments.

[0085] It will be apparent to those skilled in the art that various modifications and variations can be made in the methods and systems of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. An apparatus for measuring blood pressure of a subject, comprising: a skin contact area sensor configured to measure a finger area; a camera configured to measure a finger photoplethysmography (PPG) waveform; a screen configured to display visual indicators to guide the subject in placing a fingertip on the camera and screen to target an underlying artery, and to display finger pressure in real time so that the subject presses the fingertip evenly against the camera and screen to vary the external pressure of the underlying artery; processor; Equipped with The processor: converting the finger area into the finger pressure based on a predefined nomogram; constructing an oscillogram, said oscillogram being a function between variable amplitude blood volume oscillations and external finger pressure; calculating the subject's systolic and diastolic blood pressure from the oscillogram; displaying the systolic blood pressure and the diastolic blood pressure on the screen, wherein the predefined nomogram is configured to determine finger force from the finger area according to selected parameters of a parametric function and to determine the finger pressure by dividing the determined finger force by the finger area, the predefined nomogram including a parametric function, and the selected parameters of the parametric function are determined using an empirical equation from a training data set based on a cohort of subjects; configured to perform Device.

2. 2. The device of claim 1, wherein the selected parameters are determined based on the subject's fingertip dimensions, a single cuff blood pressure measurement, or a hand-raising maneuver, and the subject holds the device higher than heart level while pressing with their finger to obtain a more accurate nomogram, and the processor is configured to adjust blood pressure measurements to the heart level using the vertical height between the device and the subject's heart.

3. 3. The device of claim 2, wherein an accelerometer and / or a barometric pressure sensor is used to measure the vertical height of the device relative to the subject's heart.

4. The processor further comprises: measuring the acupressure and AC and DC components of the PPG waveform; calculating an arterial compliance curve using the AC component and the PPG waveform; verifying the subject's systolic and diastolic blood pressure using the arterial compliance curve; configured to perform 10. The apparatus of claim 1.

5. The apparatus of claim 1 , wherein the nomogram comprises an exponential function.

6. 10. The device of claim 1, wherein the subject lies down and holds the device face up while pressing with a finger.

7. 7. The apparatus of claim 6, wherein the calculated systolic and diastolic blood pressures are adjusted based on the subject's arm length.

8. The device of claim 1 , wherein the processor is further configured to perform the step of determining a brachial blood pressure based on the calculated systolic and diastolic blood pressures and the finger PPG.

9. The processor: determining a PPG waveform beat having a maximum oscillation, calibrating the PPG waveform beat to correspond to the calculated systolic and diastolic blood pressures, and applying a transfer function and regression equation to convert the PPG waveform beat to a brachial blood pressure beat; and determining the brachial blood pressure by 9. The apparatus of claim 8.

10. The device of claim 1 , wherein the device comprises at least one of a smartphone and a portable computer.

11. 2. The apparatus of claim 1, wherein additional parameters of the predefined nomogram are determined based on at least a first finger pressure measurement at a first height relative to the subject's heart and a second finger pressure measurement at a second height relative to the heart, the first height being different from the second height, and a difference between the first height and the second height corresponding to a known change in blood pressure.

12. 12. The apparatus of claim 11, wherein additional parameters of the nomogram are determined such that the first fingerpressure measurement and the second fingerpressure measurement provide blood pressure values ​​corresponding to the known blood pressure changes.

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