RU2785848C9 - Collection of personal medical data - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: present invention relates to medical technology and can be used to collect personal medical data. The personal portable monitor includes a personal portable computing device containing a processor and a signal detection device that can be used to perform a measurement of a parameter related to the user's health, such as the concentration of an analyte in the blood. The signal detection device is combined with a personal portable computing device and contains a blood photo sensor containing a photo emitter for emitting light onto the user's body part, a photodetector for detecting light transmitted through the body part or scattered by the body part, and an optical cell containing the analyte to be detected, through which the light passed through the body part or scattered by the body part passes before reaches the photodetector.

EFFECT: personal portable computing device adapted to process signals, received from the photodetector in the presence of a body part and in the absence of a body part to perform a measurement of the analyte concentration in the user's blood.

6 cl, 11 dwg, 1 tbl

Description

Technical field

The present invention relates to a means for collecting personal medical data. In particular, the invention relates to a personal portable monitor (hereinafter referred to as "PPM") containing a signal detection device that can be used to perform one or more measurements of parameters related to the health of a user, and the signal detection device is combined with a personal portable computing device (referred to as hereinafter referred to as "PPVU"). The PMP uses the PVD processor to control and analyze the signals received from the signal detection device. The present invention also relates to a signal detection device designed to be integrated with such a WPW. The present invention further relates to systems for operating the MRP and processing signals requested by a signal detection device. The present invention further relates to a system for analyzing, storing and transmitting signals requested by an MRP over the Internet, or for controlling the users to whom data derived from these signals can be delivered.

State of the art

Cell phones (also known as mobile phones) are part of everyday life. In the developing world, the vast majority of mature people own a cell phone. The use of cellular telephones is also becoming more widespread in developing countries, as it provides an opportunity for such countries to develop a communication system without the need for cabling. There are already various projects for the use of cell phones in health care. However, all these projects have drawbacks.

The final report by Leslie, I et al. "Mobile Communications for medical care" dated 21 April 2011 reports a landmark study from the University of Cambridge identifying the significant contribution that cellular networks will make to healthcare in developed and low-income countries and transitional economy by transferring "basic physiological parameters" and other data from local measurement devices to a central data acquisition and processing computer. It identifies two separate industries: those that make cell phones and those that make medical devices.

Ladeira D et al., "Strategic Applications Agenda Version 3", Working Group on Leading Edge Applications, January 2010, www.emobility.eu.org, is a mobile device study that takes into account the broad scope of network health and claims : "Smartphones can collect measurement results from measuring devices automatically wirelessly and without user intervention, transmit the collected data to a doctor for additional analysis."

"Healthcare unwired - new business models delivering care anywhere" PricewaterhouseCoopers(Health Research Institute, September 2010, is a paper that explores this opportunity, brought about by broad access to medical lines of communication, and its impact on the healthcare business model.

In a 2009 review, Apple identified a growing demand for its iPhones as part of the data chain from medical devices to practitioners and beyond (see http://medicalconnectivity.com/2009/03/19/apple-targets-health -care-with-iphone-30-os/).

These reports are based on the application of existing medical devices and existing cellular technology and therefore require the presence of both medical equipment manufacturing and cell phone manufacturing. The purpose of the present invention is to enable the collection of medical data without the need for both of these proceedings.

Computer tablets and portable personal computers are also getting small enough to be used as HLPE. Many of these devices also include communication tools such as WiFi or wireless phone service.

A personal digital assistant ("PDA") is also now well-known and includes a processor to enable a user to store and retrieve personal data.

Description of the invention

The first aspect of the present invention is a personal portable monitor (hereinafter "PPM") containing a signal detection device that can be used to obtain measurement results of a parameter related to the health of a user, wherein the signal detection device is combined with a personal portable computing device (hereinafter hereinafter referred to as "PPVU").

The PPM of the present invention should be of a size and weight that can be easily handled by a normal mature person using one hand to hold the PPM and the other hand to enter or retrieve data. In the preferred embodiment, the WPW includes communications such as WiFi or wireless telephone.

By "combined" is meant that the signal detector and the PVCH form a single physical unit in which the signal detector and the PVCH remain in a fixed relationship when both are moved. All electrical connections are inside the PPM.

The received signal may be analog or digital and, if analog, may be digitized for serial analysis by the PVD processor or for analysis by a remote data processing facility with which the PVD communicates via the Internet or other data transmission medium.

The PVD with which the signal detection device is integrated can be a cell phone, computer tablet, PDA, or any other computing device that a normal mature person can easily handle using one hand to hold it and the other hand to enter and retrieve data.

The present invention merges medical technology with HLAP technology by combining proven technical principles with new implementation to create a MRP that allows its user to request measurements of personal medical data only through the MRP. If necessary, the user can transfer these measurements to other parties.

The use of the PPM of the present invention is an important improvement in the scope of the systems described in the works cited above, because the signal detection device is integrated with the PVR. Because the signal detection device must be small enough to be integrated with the PVD without reducing its size and be able to take advantage of the PVD's infrastructure such as its display and battery, it will be substantially less expensive than many known medical devices that are too expensive to carry. most users in low-income or transition countries, and deter even users in developed countries. The signal detection device is manufactured using microelectronic technology to reduce the size and cost to a level where the signal detection device, combined with the PVD, can become ubiquitous and personal to the user.

In a preferred embodiment, the signal detection device is configured to receive signals as long as it is in contact or very close to one or more parts of the user's body. In particular, the signal detecting device may be configured to receive signals while at least part of it is in contact with:

one or more fingers of the user, especially one or more fingers;

skin near the carotid artery;

the user's chest, preferably closer to the heart; and/or

the inside of the user's ear or mouth.

The signal detection device includes one or more signal detection sensors that can be used to obtain a measurement result of a parameter used to assess human health. In a preferred embodiment, one or more sensors are positioned to detect signals related to blood pressure, pulse wave velocity, blood pressure waveform, temperature, blood oxygen partial pressure, electrocardiogram, heart rate, and/or respiratory rate. The signal detecting device may include sensors for detecting signals from which measurements of more than one of the above parameters can be obtained. The signal detection device preferably includes one or more signal detection sensors from which blood pressure measurements can be obtained by, for example, one or more sphygmomanometers, photoplethysmographs and pulse wave velocity measurements.

The PPM of the present invention may include one or more of the following sensors and measuring instruments. In particular, preferred combinations of these sensors and means are indicated below.

Temperature sensor

The signal detection device may include a temperature sensor for detecting signals, from which a measurement of local body temperature (ie, temperature near the location of the sensor applied to the body) can be obtained by means of the HLCP processor. It is of particular advantage that the signal detecting device also includes a sensor for detecting signals from which a room temperature measurement can be obtained by means of a processor. This may be the same sensor used in connection with local temperature measurement, or it may be a separate sensor. In a preferred embodiment, the processor is configured to obtain the user's core body temperature from signals received by the temperature sensor.

As is well known, the temperature of a surface can be estimated by measuring the thermal radiation it emits. For ordinary body temperatures, radiation is concentrated in the far infrared region. They can be recorded by a bolometer in which the target is heated by incident radiation and its temperature is measured either directly by detecting a change in its resistance, or implicitly by means of a thermocouple, thermistor, or other similar device. The field of view can be set using a lens or a window. The temperature sensor can be configured to receive radiation from the inside of the ear or the temporal artery on the forehead, as in existing medical devices using this method.

The temperature sensor is preferably positioned such that it is able to measure the user's ear temperature whether or not the user is on a call. Alternatively, the temperature sensor may be positioned so that it is able to measure the temperature of the surface of the body part on which any other measurement is to be taken with the PPM, such as blood pressure measurement.

Alternatively, the temperature sensor may be positioned so that the user can orient it by manipulating the MRP device so that it is able to measure the temperature of a body part or other selected item, such as a user's garment. The MRP processor may in this case be configured to receive a signal indicative of room temperature and/or provide instructions to the user to orient the MRP so as to obtain signals indicative of body temperature and room temperature.

Alternatively, the temperature sensor may be located on a hand that can be brought into contact with one of the user's fingers or inserted into the user's ear or mouth. The arm may be fixed in a position on the signal detection device, or may be movable between an extended and retracted position, with the arm retracted when not in use. The arm can be pivoting or sliding between its extended and retracted positions.

The signal detection device may include more than one temperature sensor to determine the temperature at different locations.

The temperature sensor can be used to measure the temperature of other items such as food, local heating systems or wine.

Electrical sensor

The heart is driven by electrical signals that can be recorded on the skin and are the basis of an electrocardiogram (ECG). A simple embodiment may be to record the time at which the electrical signal that initiates the heartbeat occurs by measuring the potential difference between two separate parts of the body. With appropriate electronic processing, the time of occurrence of each initialization signal can be measured in a few milliseconds.

The signal detection device may include an electrical sensor containing two electrodes that are electrically isolated from each other, but that can be in contact with two different parts of the user's body. In a preferred embodiment, the two electrodes may be in contact with one finger of each user's hand. In another preferred embodiment, one of the electrical sensor electrodes is connected to a button, pad, or strip of blood flow restrictors (see below). The other electrode is placed on a separate part of the PPM. This other electrode may be connected to a lever, if provided, which is used to manually inflate the pad (see below). In a preferred embodiment, the pad is designed with a surface that provides good electrical connectivity, such as a micropyramidal surface.

In another preferred embodiment, the signal recorded by the electrical sensor is a measure of the potential difference between two electrodes, which is related to the potential difference between two different parts of the body. In the preferred embodiment, the PVD processor is configured to amplify the electrical sensor signals and, if necessary, filter the signals before, during, or after the amplification. The amplified and filtered signal received by the processor generally has the shape shown in FIG. 1 in the attached drawings, where the x-axis represents time and the y-axis represents potential difference. The arrows in Fig. 1 shows the time at which the electrical signal stimulates the heart to initiate systole.

Means of restricting blood flow

The signal detection device may comprise blood flow restriction means to restrict or completely block blood flow through the user's body part, and a pressure sensor to detect pressure exerted by, or conversely against, the blood flow restriction device. A common means of restricting blood flow is an inflatable cuff that surrounds a part of the body.

Preferably, the signal detection device includes one of the means for restricting blood flow described below: a button; fluid-filled pad; and a strip. Any of these agents can be used to compress a body part, such as a toe or a finger, preferably a finger, the arterial flow through that body part being influenced by pressure applied to one side of the body part, or vice versa.

The degree of limitation may be recorded by an oscillometric method or by analysis of the signals from the blood photosensor, described below.

Button

The means for restricting blood flow may include a button that is pressed against the body part. In the preferred embodiment, the button is an area of the plate that can move independently of the rest of the plate and is connected to a force sensor. The force sensor is configured to measure the force applied to the button, but minimizes the distance that the button can move. In general, the plate measures 10 mm by 20 mm with a round button usually 5 mm in diameter or a non-circular button of equal area. In the preferred embodiment, the distance that the button moves under the action of force from the part of the body is not more than 0.1 mm.

Pressing the button on a body part creates pressure within the body part. The part of the body in contact with the button pushes the button with a force approximately equal to the pressure inside the body part times the area of the button. By measuring the force, the PPM can accurately determine the pressure value inside a body part.

The signal detection device may include a plurality of buttons, each of which is connected to a separate force sensor.

Fluid Filled Pad

The means for restricting blood flow may comprise a fluid-filled pad against which one side of the user's body part, in particular a finger, preferably a hand finger, can be squeezed to restrict blood flow through that body part, and a pressure gauge to provide a signal indicative of the pressure in the pad. In the preferred embodiment, the pad is located in the V-shaped groove of the PPM. In use, pressure can be applied to the pad either by pressing the body part against the pad or by pressing the pad against the body part.

If the pad fills with air, care must be taken to prevent overpressure that develops in the pad. It may increase, for example, if the device is left in a hot place and the heat causes the pressure to rise excessively. Preferably, the means for preventing overpressure include a valve that opens to release the gas from the pad to the atmosphere at a given pressure, which is equal to the maximum allowable pressure in the pad (typically about 300 mm Hg), and a pump for replacing the released gas. The pump may include a piston and a cylinder, or it may include a diaphragm and a chamber, the piston or diaphragm may be actuated by the user or electrical power. In the preferred embodiment, the PPM has a hinged or retractable cover over the signal detection device, located so that opening the cover allows the device to be used, the cover presses on the piston or diaphragm to create enough pressure to re-inflate the pad. In the preferred embodiment, the pump has two valves: a non-return valve that allows gas to enter the pad; and a valve for allowing gas to exit the pump to atmosphere at a predetermined pressure equal to the minimum operating pressure of the pad (typically about 50 mmHg).

It is of particular advantage that the volume of gas present in the pad is kept to a minimum in order to maximize the sensitivity of pressure change detection. In the case of a non-return valve, it is preferable to place it close to the pad and to the pressure sensor.

An additional benefit of including this safeguard is that the device continues to operate even if a slight leak has formed. This improves the reliability of the device.

Strip

In yet another alternative embodiment, the means for restricting blood flow may comprise a strip against which one side of the user's body part, in particular a finger, preferably a finger, can be pressed to restrict the flow of blood through this body part, and a force sensor for issuing a signal indicative of the pressure. rendered on the strip.

In the preferred embodiment, the strip is located on the V-shaped groove of the PPM. In use, pressure can be exerted on the strip either by pressing the body part against the strip or by pressing the strip against the body part.

The strip may be inelastic or elastic.

In the case where the strip is inelastic, it can be fixed at each end across the V-groove in the PPM. In this arrangement, the pressure gauge is adapted to measure the force applied to the strip fasteners.

Alternatively, the non-elastic strip may be fixed to the roller on one side of the groove and fixedly fixed on the other side of the groove. In this arrangement, the pressure exerted on the strip can be measured by the amount by which the strip has rolled the roller. Unwinding can be counteracted by means of a torsion spring on the roller or a linear spring.

In yet another alternative, a non-elastic strip may be attached to each of its ends on a roller, and the rollers are located on each side of the V-groove in the MRP. In this arrangement, the pressure exerted on the strip can be measured by the amount that the strip twists each roller, or by measuring a physical property of the strip, such as its electrical resistance.

In the case where the strip is elastic, it can be fixed at each end across the V-groove in the PPM. In this arrangement, the gauge can be adapted to measure the increase in strip length or tensile stress in the strip, or to measure a physical property of the strip, such as its electrical resistance, to provide a signal related to the pressure exerted on the strip.

In the case of a strip, it is preferable that the PPM include signaling means indicating the diameter of the part of the body that comes into contact with the strip, so that the pressure measurement can be made more accurately. The means may be a keypad or touch screen, preferably a standard keypad or touch screen PVR, whereby the user can enter the diameter as a result of its measurement, for example by any convenient means such as a tape measure or a series of calibrated lengths created on a separate instrument or on PPM.

Preferably, however, these means are associated with the strip itself and signal without user data. For example, the strip may include one or more optical fibers embedded therein, a light source at one end of the optical fiber (KNA) for injecting light into the optical fiber (KNA), and a light detector at the other end of the optical fiber (KNA) for detecting light. reached the detector, and means for determining the attenuation of light as it passes through the optical fiber (kna), the degree of attenuation being related to the curvature of the strip, which in turn is related to the diameter. Alternatively, the strip may comprise two layers and the signal detection device includes means for measuring the length of each layer, the relative lengths of the two layers depending on the diameter. In yet another alternative embodiment, the signal detecting device may include means, such as a proximity detector, for providing a signal indicative of the distance between the bottom of the groove and the nearest point on the strip, and a processor adapted to calculate the diameter of a body part from the signal and strip length.

Blood photosensor for photoplethysmography (PPG)

Pulse oximeters used in PPGs have been on the market since the 1980s. They are used to assess the degree of oxygenation in arterial blood. Red and infrared light is sent to some part of the body. Infrared light is absorbed more strongly by oxygenated blood than by non-oxygenated blood; red light is absorbed more strongly by non-oxygenated blood than by oxygenated blood. The change in infrared absorption during systole serves as a measure of the amount of oxygenated blood. The level of absorption of red light between systoles serves as a measure of the total amount of exposed blood and is used for calibration.

In a preferred embodiment, the signal detection device includes a PPG sensor. It uses one or more photo sensors. The photosensor(s) can be placed to measure transmission or scatter. In the variant of the passage, the photosensor contains one or more photoemitters located for passing light through a certain part of the body, and one or more photodetectors located for detecting light passing from the photoemitter(s) through this part of the body. In the scattering variant, the photosensor comprises one or more photoemitters located to pass light towards a certain part of the body, and one or more photodetectors located to detect light from the photoemitter(s) scattered by this part of the body. In the preferred embodiment of the scattering option, the photodetector(s) is located in close proximity to the photoemitter(s).

In both cases, it is preferred that the photosensor(s) be(are) configured to emit and detect light of two or more wavelengths. One combined photoemitter is possible, configured to emit light of two selected different wavelengths, or at least two photoemitters are possible, each of which is configured to emit light of a selected different wavelength. For both alternative photoemitter(s), one alternative embodiment provides one combined photodetector that can detect light at selected wavelengths. In another alternative, two or more photodetectors are provided, each configured to detect light at a selected, different wavelength.

In a preferred embodiment, one of the wavelengths is chosen so that the light is absorbed more strongly by oxygenated blood than by deoxygenated blood. A suitable wavelength is 940 nm. Another wavelength is chosen so that the light is absorbed more strongly by deoxygenated blood than by oxygenated blood. A suitable wavelength is 660 nm.

In a preferred embodiment, the signal detecting device is configured to receive a signal from the photodetector(s) when no light is emitted from the photoemitter(s). This makes it possible to additionally calibrate the signals received at the first and, if the second is provided, then at the second wavelength (n).

In FIG. 2 of the attached drawings shows in a simplified way the change in the oxygenated blood signal (upper line), the deoxygenated blood signal (middle line) and the ambient light signal (lower line).

The blood photosensor may be further configured to measure the concentration of blood analytes such as glucose, alcohol, hemoglobin, creatinine, cholesterol, and stimulants or other drugs, including illegal or otherwise prohibited materials. It is difficult to make these measurements if the absorption spectrum of the analyte is similar to the absorption spectra of other materials in the blood. The signal detection device may be designed to apply one or more of the techniques described below to increase the sensitivity and selectivity of absorption spectroscopy.

The first method should be attributed to differential absorption. A beam of light is directed to some part of the body and the transmitted or scattered light is split and directed to two measuring cells. One (reference cell) contains a mixture of chemical compounds normally present in sufficient quantities in the blood, excluding the analyte of interest. In practice, it contains only water. The other (test cell) contains the same mixture and analyte. Alternatively, the reference cell may be omitted and the test cell filled with analyte only. Alternatively, if the analyte is gaseous under normal conditions, the light beam can pass through a separate test cell containing the analyte in gaseous form and the pressure in that cell fluctuates.

The intensity of the light beam can be measured under different conditions: after passing through the reference cell and independently through the test cell, in each case without the presence of a body part, and similarly after passing through each cell in the presence of a body part. In an alternative embodiment, the intensity of the light beam can be measured both when it passed through the cell and when it did not pass through it, with and without the presence of a body part. In another implementation, the intensity can be measured as a function of pressure in the cell with and without the presence of the body part.

The intensity of the light beam can be modulated, for example by switching, in order to compensate for background light by the measurement system. The beam of light has a broad optical spectrum, chosen to minimize the difference between the presence of the analyte and other chemical species, while providing the low cost technology needed for the application. For example, if the analyte is glucose, this may be near the IR region.

In each of these cases, the difference between the intensity when the light beam passes through the reference cell and through the test cell serves as a measure of the amount of absorption by the analyte within the body part. To further improve PPG blood analyte concentration selectivity, a signal can be used to identify the time at which the artery dilates during systole. The change in absorption at this point results only from the additional amount of blood in the body part. The volume of this extra blood is also estimated from the PPG signal.

acoustic sensor

The PPM may include an acoustic sensor to detect signals associated with sounds generated by the heartbeat. The acoustic sensor may be a separate microphone, geophone, or vibration sensor, or it may be a microphone for a standard cell phone or computer tablet for speech perception, or it may be a force or pressure sensor used to measure pressure in a body part during arterial blockage. In a preferred embodiment, the PPM processor is configured to process the signals received by the acoustic sensor to determine the moments of the heartbeat.

In FIG. 3, in the attached drawings, shows a typical "knock-knock" heartbeat pattern that could be obtained by means of an acoustic sensor. Two successive pulses are shown. A signal consists of an audio signal within an amplitude envelope.

Motion Sensor

The PPM may also include a motion sensor that is configured to detect the location of the user's body part on which the signal detection device is located. In the preferred embodiment, the PPM processor is configured to correlate the signal from the motion sensor with the signal from the pressure sensor to enable calibration of blood pressure measurements. In a preferred embodiment, the MRP processor is configured to instruct the user, either verbally or visually, to move the body part so that such calibration can be performed. The motion sensor may be an existing component of the WPW. It can detect inertial forces by accelerating the PVV or changing pressure with altitude.

ultrasonic sensor

The signal detecting device may include an ultrasonic transducer to form an image of the cross section of the artery and/or use a Doppler interferometer to estimate the velocity of blood flow within the artery. The specified ultrasonic sensor may consist of a set of individual elements that form an array.

Personal data entry tool

In a preferred embodiment, the PPM includes a means for entering personal data and is configured to store other personal data. Preferably, the personal data entry means is a keypad or touch screen, preferably a standard HLPE keypad or touch screen. Data that can be entered by these means may include, but is not limited to: height, weight, waist circumference, finger diameter, and age.

Additional sensors and tools

The PPM may further include means for applying electrical signals to the user's body and detecting signals generated by the first signals, for example, to measure body properties such as body mass index.

The PPM may include a sensor capable of receiving signals from which user identification data, such as data for obtaining a user's fingerprint, can be obtained. This makes it possible to ensure that the obtained measurements relating to the user's health can only be associated with that user. Such an identity sensor may be associated with a flow restrictor pad or may be associated with an electrical sensor electrode. It is possible to position the identity sensor in such a way that it is almost impossible to correlate the measured medical values to any person other than the user being identified.

Data analysis

The sensors and tools described above can be used in various combinations to enable the collection of various medical data. One or more of the following sensors can be included in the PPM: a temperature sensor, an electrical sensor, blood flow restrictors, a blood photo sensor for PPG, an acoustic sensor, a motion sensor, an ultrasonic sensor - and preferably include at least the first four of them. Preferred combinations of sensors and means are shown in the table below, along with indications of medical data that can be obtained through these combinations. However, those skilled in the art should understand that other combinations can be used to provide additional medical data and that the present invention should not be limited to the combinations shown in the table below.

The table does not refer to the analysis of data obtained from a possible extension of the optical sensor to measure the concentration of the analyte in the blood.

Algorithms relating to the combination of signals from any or all of the specified sensors and facilities included in the MRP, and from other sensors that may be part of the PVSP, can be applied to convert the received signals into relevant medical data or improve the accuracy of the received medical indicators ("basic physiological parameters"), such as systolic and diastolic blood pressure. Other medical indicators that are less known but recognized by medical professionals, such as arterial wall stiffness and pulsatile arrhythmia, can also be extracted. Any or all of these models may be coded as software and may be loaded into a PPM or a remote computer for signal processing.

In a preferred embodiment, the MRP processor is configured to issue verbal or visual instructions to the user to enable him to use the MRP as desired. In this case, it is preferable to adapt the processor so that the instructions are interactive and based on signals received from the signal detecting device, which can be used to determine if the signal detecting device is in the best position or if it is applied correctly.

It is preferable to adapt the processor to take multiple measurements and correlate all of these measurements to provide a better indication of medical data.

One possible arrangement by which the data of the senders is analyzed is described after the table.

Body temperature

The accuracy of the core temperature estimate can be improved by adapting the PVD processor to provide verbal or visual feedback to instruct the user to move the PPM so that the temperature read is maximum, for example, when the PPM is against the user's ear and moves to make sure the sensor is directed to the warmest place.

In a preferred embodiment, the temperature sensor is located in the PPM so that the PPM is able to cover the part of the body whose temperature is to be measured, such as the ear. In this case, during operation, the temperature may rise to the internal temperature, because airflow is excluded due to the presence of the PPM. The temperature sensor can be placed next to or combined with a loudspeaker or other device used to reproduce sound in the PVH.

In the preferred embodiment, the processor is configured to record the measured temperature over a period of several seconds and apply a mathematical model to extrapolate to the expected equilibrium temperature.

The MRP processor may be configured to analyze the signals from the temperature sensor to provide an estimate of the user's core body temperature. The processor may be further adapted to perform analysis to identify core temperature trends and other acquired diagnostic value information.

Pulse rate

The timing of each pulse can be determined from the electrical signal that indicates the initialization of systole, as well as from the time of arrival of the systolic pulse to the body part against which the device is pressed, indicated by pressure on the pressure or force sensor located in the blood flow restriction means, and by the absorption maximum, registered by an optical and / or acoustic sensor, if any.

The average pulse repetition rate that is most compatible with the data of each of these sensors is found by optimizing a mathematical algorithm, for the implementation of which the PFVU processor is adapted. This algorithm can be a simple least squares difference calculation with weights, a Bayesian estimate, or some other optimization technique to find the most likely estimate.

Pulse arrhythmia

Arrhythmia is a term used to refer to a change in the interval between pulses. Patterns of such changes are a valuable diagnostic tool.

Changes can be obtained from the same data used to find the average pulse rate, again if necessary, using an optimized mathematical algorithm.

Blood pressure

Blood pressure can be estimated by combining data from four different types of readings: pulse wave velocity, pulse filling, sphygmomanometer, and pulse rate. The sphygmomanometer itself is derived from two different measurements: the high frequency signals from the manometer and the blood photosensor(s). You can also use external data such as height, weight, age and gender of the user. Thus, to obtain the most reliable blood pressure estimate, five independent measurements and some data can be combined through a mathematical optimization algorithm such as Bayesian estimation.

The values obtained represent the systolic and diastolic blood pressure at the location of the body part where the measurement is taken. And other diagnostic information can be obtained from these signals through additional mathematical models. For example, as a result of the analysis, blood pressure can be calculated at another point in the body, such as the upper arm, to enable direct comparison with conventional blood pressure cuff measurements. This can be a calculation of aortic pressure as well as arterial stiffness.

If necessary, the PPM may include an additional temperature sensor to locate the artery to be examined.

Each type of blood pressure measurement is described below.

Pulse Wave Velocity

The pulse wave propagation velocity (PWV) can be derived from the pulse wave propagation time (PWTT).

The use of PWV to assess blood pressure (BP) is described in detail by Padill et al. (Padilla J et al., "Pulse Wave Velocity and digital volume pulse as indirect estimators of blood pressure: pilot study on healthy volunteers" Cardiovasc. Eng. (2009) 9: 104-112), which in turn refer to earlier work on a similar topic from 1995 and its specific application to the assessment of BP in 2000. The method is described in US Pat. No. 5,865,755, issued Feb. 2, 1999. It is based on research indicating that the speed of the blood pulse through the arteries is a function of blood pressure.

In a preferred embodiment, the PPM processor is adapted to derive an estimated PWV from the signals received from the electrical sensor and the PPG of the sensor. The processor is adapted to process the signal from the electrical sensor to provide an indication of the time at which systole (heart beat) begins and process the signal from the photosensor to determine the time of the peak in the oxygenated signal, which indicates the time at which the pulse reaches the measurement point. The interval between them is the propagation time of the impulse from the heart to the measurement point (PWTT). The processor is adapted to determine BP relative to this interval, which is typically 300 ms for measurements at the end of the wrist or arm.

In a preferred embodiment, the processor is adapted to allow the use of two additional pieces of information for PWV estimation: the time delay between the electrical initialization signal and heart systole initialization; and the length of the trajectory between the heart and the measurement point.

In a preferred embodiment, the processor is adapted to analyze an acoustic signal to extract an envelope (analog for searching in radio signals) and use an automatically set threshold to identify a point that indicates the initialization of systole. In practice, this may be at a predetermined portion of the curve from background to peak, as shown in FIG. 4 of the attached drawings, where the vertical arrows show the time when the heart responds to the physiological electrical initialization signal and initiates systole. This is usually a few tens of milliseconds after the initialization electrical signal. In an alternative implementation, the processor is adapted to match the curve with the waveform for more robust estimation.

In an alternative implementation, the time delay can be estimated by measuring the PWTT to two different parts of the body, such as the carotid artery and the finger. The time delay can therefore be found from knowledge of the usual ratio of the lengths of the trajectories from the heart to two different parts of the body.

In the preferred embodiment, the PPM is adapted to store the time delay in a non-volatile memory. The time delay may be stored automatically when it is measured or memorized by the user via a keypad or touch screen, preferably a standard keypad or PVD touch screen.

In a preferred embodiment, the PPM is adapted to store in non-volatile memory a value associated with the length of the trajectory between the heart and the measurement point. It can be entered into memory by the user through the keypad or touch screen. The value entered may be an exact measure of length, or may be a value that is approximately proportional to true length, such as the user's height.

Pulse filling

Pulse filling can be obtained from a blood photocell (BPH). The use of PPG to assess blood pressure is presented in the report X.F. Teng and Y.T. Zhang at the IEEE EMBS, Cancun, Mexico, September 17-21, 2003. The main method is the subject of U.S. Patent No. 5,140,990, issued August 25, 1992. The change in infrared absorbance during systole is a measure of the change in the volume of the irradiated artery, which is associated with pressure inside the artery.

In addition, data can be obtained from an analysis of the shape of an absorption peak during systole, such as an analysis of the total area under the peak.

In the preferred embodiment for an oxygenated blood signal, the PPM processor is adapted to derive blood flow properties, such as relative amplitude and period of the direct and reflected pressure wave, from the shape of the curve, such as the area under the peak, its width at half height, and the height and width of the arm. At the request of the user, the MRP processor can be adapted to calculate their ratios in order to reduce the impact of changes in exposure and location relative to the body part. These relationships can be applied to characterize the properties of the blood flow.

The MRP processor is preferably adapted to analyze the signals from the PPG sensor to provide a direct estimate of the systolic and diastolic blood pressure at the measurement point.

Sphygmomanometry (Clamping of an artery)

Sphygmomanometry is an established method for measuring blood pressure, which has been used for over 100 years. Variable external pressure is provided by a cuff located around the part of the body through which the artery passes. Pressure reduces the cross section of the artery and restricts blood flow during systole.

Sphygmomanometry is usually done with a cuff that surrounds a part of the body and is inflated to a pressure that stops all blood flow; The pressure is then slowly reduced. Systolic BP is measured by finding the lowest pressure that completely blocks flow. Diastolic BP is measured by finding the highest pressure that does not cause any restriction. The flow is usually recorded by an experienced practitioner with a stethoscope to hear sounds of flowing blood (Korotkoff sounds).

Automated blood pressure monitors detect flow either by detecting fluctuations in cuff pressure caused by flow (oscillometric method, see for example Freescale Application Note AN1571, "Digital Blood Pressure Meter") or by optically sensitive small film movements. The value of these fluctuations is an indicator of the degree of limitation. More recently, PPG has been applied by combining sphygmomanometry with measurement of pulse filling (see Reisner et al., "Utility of the Photoplethysmogram in Circulatory Monitoring" Anesthesiology 2008; 108: 950-8).

The signal detection device may use any one of the three restraints described above: a fluid-filled pad, a strip, or a button. It uses both pressure fluctuations and pulse filling measurements to determine systolic and diastolic pressures.

Unlike conventional sphygmomanometry, flow can be recorded over a range of pressures, in any order and in any magnitude, and substituted into a known mathematical equation to perform blood pressure measurements. Preferably, the processor is adapted to give audible or visual instructions to the user to change the force applied to the body part to cover a wide enough pressure range to give a better fit to said mathematical equation. For example, if the user does not press hard enough on the button, strip, or pad above to completely occlude the blood vessel during systole, the device can be programmed to instruct the user to press the occlusion device harder (or vice versa) so that the necessary data is obtained. .

Apparently, this provides an opportunity to arbitrarily choose the pressure exerted on the means of restricting blood flow. During the blood pressure monitoring process, the user can change the pressure exerted on the button, pad, or strip mentioned above arbitrarily. However, blood flow sensor data can be correlated with a pressure gauge signal from a button, pad, or strip to match the measured data to a known theoretical relationship between flow rate and pressure (see, for example, the model shown on page 954 by Reisner ("Utility of the Photoplethysmogram in Circulatory Monitoring" Anesthesiology 2008; 108: 950-8)).

Pulse rate

The pulse rate can be measured independently and can be used as an indicator of blood pressure. AI Jaafreh ("New model to estimate mean blood pressure by heart rate with stroke volume changing influence", Proc 28th IEEE EMBS Annual Intnl Conf 2006) concluded that: "The relationship between heart rate (HR) and mean blood pressure (MAP ) non-linear". The article also shows how correction for systolic heart volume can compensate for some of the non-linearity. The systolic volume of the heart is evaluated independently (see below), and personal data can also be applied.

blood oxygen

The blood photosensor can use PPG to assess blood oxygen levels. At least four variables can be derived from the measured absorbance at two wavelengths. They represent the amplitude of the recorded signal at each wavelength during systole and between systoles. The arrow in Fig. 2 shows one of the values that can be derived from them, with the height of the peak corresponding to the change in signal from oxygenated blood during systole. It has been found that these four quantities can be analyzed to assess blood oxygenation (see, for example, Azmal et al., "Continuous Measurement of Oxygen Saturation Level using Photoplethysmography signal", Intl, Conf. on Biomedical and Pharmaceutical Engineering 2006, 504-7) .

Pulse Wave Velocity

The pulse wave propagation time can be measured as above and converted into an estimated value of the pulse wave propagation velocity. This information is of direct diagnostic value to the physician, especially when taken into account together with all other data obtained from the signal detection device of the present invention.

Respiratory cycle

The state of the respiratory cycle can be obtained from several data sets measurable by the present invention:

pulse repetition rate (measured by means of an electrical sensor and a blood photo sensor, see above); mean arterial pressure (see above); and

amplitude of the systolic impulse (measured by PPG, see above).

The results of all these measurements can be combined through an optimized mathematical algorithm, such as Bayesian estimation, to obtain the most reliable description of the amplitude and phase of the respiratory cycle.

Blood flow rate/systolic heart volume

The volume pumped out by the heart per beat is usually measured by ultrasound scanning. The area of the aorta is set from the image, and the flow velocity from the Doppler shift. This is a proven and inexpensive method, but is available only in a doctor's office.

Before ultrasound was readily available, a convenient and almost non-invasive method was to estimate the time spent circulating blood through the body. This is due to the pulse repetition rate and the volume pumped out for each pulse. The method used a safe, strong-tasting chemical injected into a vein in the arm and measured the time until it reached the patient's tongue and could be felt.

The present invention provides for a similar measurement to be made by perturbing the respiratory cycle. The PVR can be adapted to command the user to hold their breath. The oxygen level in the lungs starts to drop and the oxygenation of the blood in the lungs drops with it. Once this blood reaches the point in the body where measurements are taken, the oxygen level in the blood will drop noticeably. The time interval, when combined with valid or entered data regarding path length, is a measure of the flow rate. The PVR also commands the user to resume breathing, and the time taken before the blood oxygen begins to rise can also be measured.

Remote data processing

The MRP is able to perform and display measurements of any, or any combination, or all of the "basic physiological parameters" listed above without any external data processing. Additional properties and improved accuracy can be obtained through external data processing, using the communication capabilities of the PVSP to connect to the Internet, cellular telephone network or other means of communication.

In the preferred embodiment, each PPM in accordance with the invention has a unique, immutable, machine-readable identifier. It can be provided during production or testing. Moreover, it is preferable to include a scheme for encrypting the measured data in each PPM in a manner unique to that device.

In one embodiment of the present invention, the PVSP reads the unique identifier when the MRP is applied for the first time and transmits this identifier to the remote data protection service (RSDS) via the Internet. The RSDS loads the necessary software, calibration data, and decryption key into the PVSP to extract the data from the PPM. This is a more secure way of encrypting the proper calibration of the signal detection device and minimizing the time required for installation and final testing of the PPM in the PVD. It is preferable to further program the PVD to communicate the measured data directly to the user, eg via a visual display or aloud. In the preferred embodiment, communication is via a visual display. If necessary, the processor can be programmed so that the display shows not only the measured parameter(s), but also the direction of change of the measured parameter(s).

As an option, the software may be time limited, requiring the user to revalidate with RSDS after a period of time. As an option, the user may be required to pay for a license to enable some or all of the features.

Alternatively, the decryption key and calibration data may be stored via RSDS. The HLPP transmits the encrypted seed from the PPM to the RSDS for analysis. RSDS also returns decrypted, calibrated data for further processing and display to the user's screen.

RSDS may further process the measured data to obtain greater accuracy or additional diagnostic or indicator data. This data can be relayed to the PVSP for display on the user's screen.

The PVV can also be programmed via RSDS to transmit received signals or measured measurements to a remote computer system, such as a user, clinical, health care provider, or insurance company, where the received signals or measured results can be processed remotely, for example, to provide more accurate analysis. or to interpret test results either automatically or by an experienced physician. If the processor is programmed in this way, then it can also be programmed to receive the results of such analyzes and display them on the user's screen, as described above.

The PVSP can also be programmed via RSDS to allow third party applications (commonly known as "apps") to access data from the MRP. Such permission may be given subject to the payment of a license or APP signed by the relevant regulatory authorities.

The PVSP can also be programmed to provide information related to the measurement result(s) obtained, such as normal applications or recommendations for use.

RSDS can offer the service of storing many measurement results from PPM and trending and other derived information for the user. This may be associated with an automatic alert service in case of any important change in the data. In addition, signals or measurements may be anonymous and collected from groups of systems or all PPM systems of the present invention so that they can be used for research purposes.

Mechanical design

A number of different sensors and means, as mentioned above, may be included in the MRP. They can be included individually or in any combination of two or more sensors. For example, a combination of a sensor for measuring pressure applied to or against a pad, strip or button, a photosensor for measuring blood flow in the pressured part of the body, and an electrical sensor for measuring pulse rate is particularly useful. to provide more accurate blood pressure readings. In a preferred embodiment, the PPM integrates one or more application specific integrated circuits (ASICs), one or more measurement systems implemented on a chip (MEMS), and/or photoemitters and/or photodetectors. They may be combined as independent silicon devices in a separate package, or preferably some or all of them may be included in one or more silicon devices. Such integration will result in some benefits in terms of lower cost, improved reliability, reduced size and weight, and lower power consumption.

In the preferred implementation, the MRP utilizes other PVD capabilities for calibration and operation.

Four embodiments of the present invention are now described, by way of example only, with reference to the accompanying drawings, in which:

in fig. 1 shows a generalized amplified and filtered signal obtained by means of an electrical sensor;

in fig. 2 shows in a simplified way the change in the oxygenated blood signal (upper line), the deoxygenated blood signal (middle line) and the ambient light signal (lower line) received from the PPG sensor.

in fig. 3 shows a typical knock-knock heartbeat signal received from an acoustic sensor;

in fig. 4 shows the envelope obtained from the acoustic signal of FIG. 3;

fig. 5 is a simplified illustration of the first embodiment of the present invention;

fig. 6 is a simplified illustration of the second embodiment of the present invention;

fig. 7 is a simplified illustration of the third embodiment of the present invention;

fig. 8 is a simplified illustration of a fourth embodiment of the present invention; and

on each of Figs. 9, 10 and 11 show the layout of the PPM according to the present invention, which uses an optical sensor.

It should be clearly understood that the following description of these three embodiments is presented solely for the purpose of illustration and that the scope of the present invention is not limited to this description; more specifically, the scope of the invention is set forth in the appended claims.

In FIG. 5 shows a detail of the module, which is one of the embodiments of the invention and is installed in a cellular phone. A flexible bellows (1) hermetically seals the end of the module housing (9). The bellows (1) is filled with an inert transparent liquid. The bellows is transparent in the center and, around the transparent area, is metallized to make electrical contact with the finger. Metallization can use a micropyramidal or other rough structure to improve electrical contact.

One or more photoemitters (2) transmit light (shown in dotted line) through the bellows (1). One or more photosensors (3) detect the light scattered back from the pin (15) pressed against the bellows (1).

The manometer (4) measures the pressure in the liquid. The temperature sensor (5) detects the temperature of any object in its field of view, which is located above the module.

The metal layer, photoemitter(s), photosensor(s), pressure gauge and temperature sensor are all connected to the electronic control and interaction unit (6). The cable (7) from this unit is connected to the cell phone processor via a standard I2C interface. A second cable (8) connects this block to a contact pad (14) on a cell phone used to make electrical contact with another finger.

The photoemitter(s), photosensor(s), pressure gauge, temperature sensor, and electronics may be independent silicon chips, or some or all of them may be integrated into a single chip.

The module is located on the cell phone body (12) above the screen (11). The contact pad (14) for contact with the finger of the other hand is located in the lower part of the cell phone case. The user presses his index finger (15) against the bellows (1) to take a measurement. The temperature sensor is located behind the window (16).

In FIG. 6 shows the details of the second module, which is another embodiment of the invention and installed in a cellular phone. An inelastic strip (21) is attached to the body (29) of the module. The surface of the strip is metallized to make electrical contact with the user's finger.

One or more photoemitters (22) emit light (shown in dotted line) next to the strip. One or more photosensors (23) detect light scattered back from the finger.

There is a slot (24) in the housing below the attachment point of one end of the strip. The beam formed by this slit is deformed when a force is applied to the strip and the deformation is measured by the tension gauge (25). The proximity sensor (31) measures the distance from the strip to the module body. The temperature sensor (26) detects the temperature of any object in its field of view, which is located above the module.

The metal layer, photoemitter(s), photosensor(s), pressure gauge, proximity sensor and temperature sensor are all connected to the electronic control and interaction unit (30). The cable (27) from this unit is connected to the cell phone processor via another standard I2C interface. A second cable (28) connects this block to a contact pad (34) on a cell phone used to make electrical contact with the finger of the user's other hand.

The photoemitter(s), photosensor(s), proximity sensor, pressure gauge, temperature sensor, and electronics may be independent silicon chips, or some or all of them may be integrated into a single chip.

The module is located on the body of the cell phone (32) above the screen (33). The contact pad (14) for contact with the finger of the other hand is located in the lower part of the cell phone case. The user presses his index finger (35) against the strip to take the measurement. The temperature sensor is located behind the window (36).

In FIG. 7 shows the details of the third module, which is another embodiment of the invention and installed in a cellular phone. The elastic strip (41) is attached at one end to the module body (49) and the other end passes over the roller (45) to the spring (44). Inside the spring is a sensor (not shown) to measure its length. The surface of the strip is metallized to create electrical contact with the finger.

One or more photoemitters (42) emit light (shown in dotted line) next to the strip. One or more photosensors (43) detect light scattered back from the finger.

The proximity sensor (51) measures the distance from the strip to the module body. The temperature sensor (46) detects the temperature of any object in its field of view, which is located above the module.

The metal layer, photoemitter(s), photosensor(s), spring length sensor, proximity sensor and temperature sensor are all connected to the electronic control and interaction unit (50). The cable (47) from this unit is connected to the cell phone processor via another standard I2C interface. A second cable (48) connects this block to a pad (54) on a cell phone used to make electrical contact with the finger of the user's other hand.

The photoemitter(s), photosensor(s), proximity sensor, spring length sensor, temperature sensor, and electronics may be independent silicon chips, or some or all of them may be integrated into a single chip.

The module is located on the body of the cell phone (52) above the screen (53). Contact area (54) for contact with the finger of the other hand is located in the lower part of the cell phone. The user presses his index finger (55) against the strip to take the measurement. The temperature sensor is located behind the window (56).

In FIG. 7 shows the details of the fourth module, which is another embodiment of the invention and installed in a cellular phone. The button (62) is recessed into the plate (61). The button (62) rests on the force sensor (63). One or more photoemitters (64) emit light (shown in dotted line) through the top of the button (62). One or more photosensors (65) detect light scattered back from the finger pressed against the button (62). The top of the button (62) is metallized (not shown).

The metal layer, photo-emitter(s), photo sensor(s), force sensor - all of them are connected to the electronic control and interaction unit (66). The cable (67) from this unit is connected to the cell phone processor via another standard I2C interface. A second cable (68) connects this block to a contact pad (73) on a cell phone used to make electrical contact with the finger of the user's other hand.

For calibration, the PVD device can be oriented up or down by the user, and this orientation can be determined by sensors in the PVD device. The change in force sensor signal due to the weight of the button in these two directions can be used to calibrate the force sensor.

The temperature sensor (69) can also be inside the button (62) or located separately and connected to the button (62). The module is located in the lower part of the body (71) of the cell phone under the screen (72). The pad (73) for contact with the finger of the other hand is located in the upper part of the cell phone.

In FIG. 9, 10 and 11 show three optical sensor arrangements to be used in the PPM of the present invention in order to measure the concentration of an analyte in the blood. They may be included in the PVV, may be connected to the PVV, or may be designed as a stand-alone device with its own user interface, power supply, and other electronic and mechanical components. The drawings do not show the means of photoplethysmography, or the mechanism for modulating the intensity of the light beam. Three illustrations show discrete optical and other components; alternatively, the sensor may be implemented as one or more integrated optical devices, where several optical components are formed as a single block of transparent plastic.

In FIG. 9, the light source (81) emits a beam of light which is passed through a filter (82) to cut out the spectral region of the light to be used. The spectral region is chosen to allow the use of inexpensive components and materials and to maximize sensitivity and selectivity to the analyte. The beam is collimated with a lens (83) to shine through a body part such as a finger (84). The light splitter (85) divides the beam between the reference cell (86) and the test cell (87). Photosensors (88) measure the intensity of the beam after it has passed through its cell. A differential amplifier can be used to amplify the signal difference between two photosensors.

In FIG. 10 shows another implementation in which the test cell (96) containing the gaseous analyte has one or more walls forming a diaphragm (109) moved by an actuator (99).

In FIG. 11 shows another implementation in which the light source and detectors are on the same side of the body part, the detectors being sensitive to light scattered back from the body part. The movable mirror (101) reflects light successively onto each of the two fixed mirrors (102) and thus onto the reference cell or cell under test. One or more photosensors (108) measure the intensity of the beam that has passed through the cells.

All depicted PPM embodiments include one or more electronic components (not shown), which may include: one or more pressure gauges, one or more analog-to-digital converters, one or more temperature sensors, a unique identifier, and an interface to electronic circuits. cell phone.

Claims (8)

1. Personal portable monitor (PPM) for collecting personal medical data, made with the possibility of holding it with one hand of the user and entering or retrieving data with the other hand of the user, containing: a signal detection device that can be used to measure a parameter related to the user's health, wherein the signal detection device is combined with a personal portable computing device and contains a blood photo sensor containing a photo emitter for emitting light to a part of the user's body, a photo detector for detecting light transmitted through the body part or scattered by the body part, and the optical cell containing the analyte to be detected, through which the light passed through the body part or scattered by the body part passes before reaching the photodetector, and a PPM processor adapted to process signals received from the photodetector in the presence of a body part and in the absence of a body part to perform a measurement of the analyte concentration in the user's blood. 2. A personal portable monitor (PPM) according to claim 1, which is adapted to take measurements one or more times during a pulse cycle in a body part, including at least one measurement taken at or near maximum systole. 3. A personal portable monitor (PPM) according to claim 1 or 2, wherein the analyte is glucose, ethanol, hemoglobin, creatinine, or cholesterol. 4. The personal portable monitor (PPM) of claim 1 or 2, wherein the analyte is an illegal or otherwise prohibited drug or stimulant. 5. Personal portable monitor (PPM) according to any one of paragraphs. 1-4, in which the optical system is integrated. 6. Personal portable monitor (PPM) according to any one of paragraphs. 1-5, which is equipped with a self-contained display, controls, computing device and power supply.

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