WO2017168029A1

WO2017168029A1 - Non-invasive sensor, device, system and method for determining training parametres during the performance of physical exercises

Info

Publication number: WO2017168029A1
Application number: PCT/ES2017/070195
Authority: WO
Inventors: María Luisa DOTOR CASTILLA; Pilar MARTÍN ESCUDERO; Mercedes GALINDO CANALES; Francisco Miguel Tobal; Romano Giannetti; Álvaro SÁNCHEZ MIRALLES; Sonnia María LÓPEZ SILVA
Original assignee: Consejo Superior De Investigaciones Científicas (Csic); Universidad Pontificia De Comillas; Universidad Complutense De Madrid
Priority date: 2016-04-01
Filing date: 2017-03-31
Publication date: 2017-10-05
Also published as: ES2640832A1; ES2640832B1

Abstract

A non-invasive, ring-shaped sensor (1) for determining blood oxygen saturation and heart rate of a person performing a physical exercise comprises a signal transmitter that transmits signals through the tissue and the arterial blood volume in the finger of the person, a receiver for receiving the transmitted signals and a first communication unit (4) that sends these signals wirelessly to a second communication unit (9) of a remote electronic device (7). In the device (7) the maximum lactate concentration, in the case of the performance of a progressive and intense exercise, and the training heart rate range are determined on the basis of the oxygen desaturation value in the arterial blood volume. The invention also relates to a system that comprises a sensor (1) and a device (7), as well as to the method for determining working zones using this system.

Description

SENSOR, DEVICE, SYSTEM AND NON-INVASIVE METHOD FOR

DETERMINE TRAINING PARAMETERS DURING THE PERFORMANCE

OF A PHYSICAL EXERCISE D E S C R I P C I Ó N

OBJECT OF THE INVENTION

The present invention relates to a non-invasive sensor for measuring and recording the oxygen saturation in blood and the heart rate of an individual; a remote electronic device to determine at what instant of time changes in variation of those parameters occur, a system to determine the range of heart rate values that define training zones and calculate the increase in blood lactate concentration of the individual and a method to determine said training zones.

BACKGROUND OF THE INVENTION

Currently, many individuals perform sports professionally, or amateur, and need systems or methods that determine biological parameters of their body to establish training plans or routines that improve their physical performance according to their physical conditions.

These systems and methods to improve physical performance are mainly based on the analysis of exhaled gases, the concentration of blood lactate, or the control of their cardiological variables, to establish different areas of physical work of the individual and individualize their training.

More specifically, the non-invasive analysis of exhaled gases is carried out by qualified personnel in facilities suitable for this purpose. Gas analysis is based on measuring the concentration of gases exhaled by the individual (oxygen and carbon dioxide) while performing a stress test. The composition of the air that inspires is measured before being inspired by the individual. With these data, together with the analysis of the volume of exhaled gases, the respiratory gas analyzers allow quantifying a series of parameters that provide information about the Cardiovascular and respiratory system behavior, and energy metabolism during physical exercise. These parameters are very useful and applicable in different areas of medicine such as cardiology, pulmonology, sports medicine or occupational medicine.

The stress test consists of performing a physical exercise of a progressive and intense type, that is, the one whose intensity increases progressively until the individual reaches the maximum effort, while monitoring certain parameters. For this, different ergometer devices are used, such as a treadmill or a cycle ergometer, choosing among them the most suitable for each individual according to the type of sport they usually practice. Throughout the entire stress test, different variables are collected, both from the gas analyzer (respiratory records), and from the electrocardiograph (heart rates). Through the respiratory records, the variations of the energy metabolism are determined since they are related to the production of different metabolites, among which lactate is found. In the respiratory records during a stress test, two significant changes are normally detected, the first one, known as aerobic threshold or first ventilatory threshold related to the beginning of a slight increase in blood lactate; and the second known, as anaerobic threshold or second ventilatory threshold, related to a greater increase in blood lactate concentration.

By knowing when the first and second ventilatory threshold of the individual is set, and the heart rate value measured at the same instant of the first and second threshold, a work zone and / or training zones limited by those points (training zone between start and first threshold, for example), as well as other parameters such as speed or load given at the time of appearance of said ventilatory thresholds, different training guidelines can be established to improve the physical conditions of the individual . These guidelines are normally based on the heart rate values obtained from the correlation between the different parameters measured in the stress test, since, of all of them, it is the most affordable to measure outside the laboratory. (López Chicharro J, Legido Maple J. Anaerobic threshold: physiological bases and applications: Interamerican; 1991).

Another known method to determine training guidelines for the improvement of an individual's physical performance is through invasive concentration analysis. of blood lactate (Simon J, Young J, Gutin B, Blood D, Case R. Lactate accumulation relative to the anaerobic and respiratory compensation thresholds. Journal of Applied Physiology. 1983; 54 (1): 13-7). This method is mainly based on taking samples of peripheral blood of the individual periodically, while he performs an incremental intensity stress test and thus determine the evolution of the lactate concentration in a given volume of blood during the test. With the temporary record of said evolution, significant changes or jumps are determined in the lactate concentration values established by the lactic thresholds, which in turn are related to the ventilatory thresholds. However, it is a bloody test, which requires a puncture on the finger or ear pulp, with the consequent discomfort for the individual.

But each method has its disadvantages. The non-invasive method of gas analysis should be performed in an effort laboratory and therefore at a high cost, which makes it mainly used by individuals who do sports professionally. In addition, due to its large dimensions and not being portable, it cannot be used in real training conditions at the foot of the track or in the field test. The invasive method of the analysis of lactate concentration is a bloody test that requires several punctures in the pulp of the finger or ear, with the consequent discomfort for the individual and also sometimes requires interrupting the cadence of the exercise physical, especially if done while the individual runs.

Due to these problems, in practice the most widely used method for training is the control of cardiological variables, especially the heart rate of the individual. Knowing the heart rate and the age of the individual, or athlete, you can estimate which is the best or optimal heart rate for training. It is, however, a non-individualized and inaccurate method.

A few years ago, trainers and physiologists determined the heart rate inaccurately by taking the pulse manually on the lateral faces of the neck (carotid pulse) or on the inner lateral face of the wrists (radial pulse). However, to perform this maneuver you have to stop performing physical exercise and, for at least 30 seconds, count the arterial pulsations. Currently, the most reliable system for determining heart rate is a record Electrocardiographic (ECG) with 12 leads, however, its use is only limited to the laboratory. For example, the method described in patent EP0785748B1 determines the threshold values for the energy metabolism of an individual based on the ECG measurement, where they analyze the signal to obtain the pulse and respiratory rate.

This is why pulsometers have been developed that allow immediate determination of the heart rate of the individual who carries them (Achten, J., & Jeukendrup, AE (2003). Heart rate monitoring. Sports medicine, 33 (7), 517 -538). The pulsometer is an electronic device that primarily measures heart rate (beats per minute) in real time. Heart rate monitors are also called heart rate monitors. More specifically, the heart rate monitors comprise a wrist watch and a band. Specifically, the measurement of the heartbeat is performed through a sensor located in said band that the individual has to put on the chest, thus detecting either changes in chest volume or pressure, or the electrical signals produced by the heart with a method similar to those of an electrocardiograph with at least one shunt. With this measurement and, based on values estimated in tables and obtained based on mathematical calculations that take into account the age of the individual, trainers, physical trainers and individuals can estimate the optimal heart rate for running or exercising physical.

The use of the heart rate monitor is always recommended, since for sports enthusiasts it is a simple way to keep the pulse rate within the limits recommended by the heart rate monitor itself. While for individuals who are professional athletes it becomes almost essential, in order to know if they are working in the heart rate intervals that the coach has demanded from them, and which are normally established based on the results of the stress test that has been done in the laboratory.

Additionally, the use of the heart rate monitor is also recommended for people with heart problems or who have suffered an arrhythmia, myocardial infarction or similar problems, and who have begun to perform regular physical exercise every day as a method of recovery therapy. These people should wear the heart rate monitor because it helps them to know if they keep the heart to the pulsations recommended by the doctor, getting an improvement without risk.

It should be noted that during training sessions where several people who use heart rate monitors coincide, it is essential that the information between each band and its clock is coded to avoid interference. It is also known that these pulsometers can sometimes be annoying for the individual since the bands must be placed around the chest, especially in female athletes.

Additionally, in some cases, electrical interference can be generated in the measurements of the band with metal parts that can go on the clothes, as is the case of fasteners with metal parts such as hoops. Also, electrical interference has been indicated in the band measurements due to the appearance of sweat during the exercise and interference in the data sent to the wristwatch. There are also other non-invasive methods to determine training zones, such as those described in US6554776B1, where the working heart rate is determined by respiratory flow measurements; or that described in US7993268B2, where the thresholds are determined by measuring acidosis in real time with respiratory methods. Also, the one described in US2009024413A1 is known where the anaerobic threshold is determined from multiple pH measurements by means of multiple spectral registers, applying various mathematical equations, and the rate of oxygen consumption based on the tissue spectrum. However, these methods have not been imposed in daily training given the complexity of the measure in almost all of them.

In recent years, other systems for determining heart rate, or heart rate, have been developed using photoplethysmography (PPG) and pulse oximetry, or pulse oximetry, as well as other indicators using optical spectroscopy (NIRs).

For example, US2006234386A1 describes the use of NIRS, where they use infrared wavelengths between 1550 and 1700 nm, and even longer lengths to measure lactate levels and in US2013096403A1, where a method is described to determine the training threshold, oxygenation of muscle tissues, lactic threshold and other parameters during physical exercise.

Today, there are many commercial houses that have developed pulse oximeters, being nowadays commonly used in the daily clinical practice of all hospitals worldwide.

More specifically, a pulse oximeter, or pulse oximeter, is a medical device that indirectly measures the oxygen saturation of the individual's blood by detecting photoplestographic signals, through emitters that emit light at least two different wavelengths and a receiver that receives the light modified by its passage through the tissues and that have reflected or transmitted it. Thus, through the analysis, by means of mathematical algorithms, of the variations of the light received by the receiver, various physiological variables are obtained, such as the heart rate (equivalent to the heart rate), or the oxygen saturation of the individual.

These pulse oximeters are normally placed on an individual's finger and comprise a pair of small light emitting diodes (LEDs) facing a photodiode and separated by a portion of the individual's body (finger). One of the LEDs is red, with a wavelength of 660 nm, and the other is infrared, with wavelengths of 905, 910, or 940 nm. The absorption that occurs from the light of these wavelengths is different, since the oxygenated and deoxygenated component of the hemoglobin present in the blood absorbs it differently, so that the relationship between the absorption of red light and infrared can be calculated the difference in concentration between oxyhemoglobin and deoxyhemoglobin and therefore the blood oxygen saturation values.

In turn, since the light signals that reach the photodiode are modulated in intensity by the heartbeat, since blood reaches pulses everywhere in the human body, the value of the heartbeat can be obtained at each moment, equivalent to heart rate measured by an electrocardiograph.

In this way, the pulse oximeters measure the heart rate and oxygen saturation, and their variation at all times. These devices can be used to monitor the physical condition of the individual while he develops the tests of effort to obtain fundamental information about the physical performance of the individual, making them another instrument in sports medicine. However, its low reliability is known especially from about 150 beats per minute since when the exercise becomes more intense or the individual moves, or gestures quickly, for example during a sprint, the signals of these systems become very loud

DESCRIPTION OF THE INVENTION In a first aspect of the present invention, a non-invasive sensor for determining blood oxygen saturation, and an individual's heart rate is described. Said non-invasive sensor comprises an anatomically circular body, such as a flexible band, ring or an anatomical ring intended to be placed around the base of an individual's finger, and which in turn houses:

«A transmitter to emit first signals of wavelength between 630 and 940 nm, on the tissue surrounding the blood volume of the finger; • a receiver to receive corresponding second signals with a transmission of the first signals through tissue and blood volume; and a first communication unit configured to receive the second signals from the receiver by cable and transmit them wirelessly.

More specifically, the emitter comprises a first and a second light generator, wherein said first and second light generator generates quasi-monochromatic lights, preferably by at least one LED diode, or monochromatic preferably by at least one laser diode, or by other quasi-monochromatic or monochromatic light generators, or a combination of the above.

The first light generator can emit a wavelength signal A below 800 nm, preferably between 630 and 780 nm; and the second light generator emits a signal B above 800 nm, preferably between 850 and 940 nm.

Preferably, the emitter comprises a first and a second light generator that emit alternately (when on A is off B and vice versa), · continuously a signal A whose wavelength is 630 or 660 nm, and a signal B whose wavelength is 850, 880, 905, 910 or 940 nm, or

• Quasi-monochromatic or monochromatic, a signal A whose wavelength is 630 or 660 nm and a signal B whose wavelength is 850, 880, 905, 910 or 940 nm.

These specific wavelengths allow the non-invasive sensor to be used reliably by individuals of any race and / or skin type.

Meanwhile, the receiver comprises at least one photodetector sensitive to signals of wavelengths of the optical spectrum between 600 and 1000 nm, where preferably the photodetector is sensitive to signals of wavelength between 630 and 940 nm.

The sensor may include a pulse oximeter that detects the second signals. In a second aspect of the invention we have a remote electronic device, portable by an individual who carries on his finger the non-invasive sensor to determine the training heart rate range of the individual in which the remote electronic device comprises:

• a second communication unit to receive the second signals from the first wireless communication unit of the non-invasive sensor,

• a processing unit, to determine:

or from the second signals, the heart rate, the oxygen saturation of the arterial blood volume, and the maximum lactate concentration in the case of performing a progressive and intense physical exercise; Y

or the training heart rate interval that defines a work zone for the individual during physical exercise, where said frequency range is obtained from the oxygen desaturation value of the individual's blood volume during the performance. of physical exercise, and

• a first interface to visually or auditively represent at least oxygen saturation or the maximum lactate concentration if a progressive and intense exercise has been performed. Before starting the exercise, you can take a baseline value of the individual, also called at rest, of blood oxygen saturation as well as other parameters

Preferably, said remote electronic device is a smart watch and / or a portable telephone.

In a third aspect of the present invention, a non-invasive system is described that includes the non-invasive lord and the remote electronic device for, from the blood oxygen saturation and heart rate of an individual, to determine training zones for an individual (which may be the specific training heart rate interval for performing physical exercise). Usually, this work zone is consistent with a range of training heart rates linked to the interval between the values of a first ventilatory threshold and / or a second ventilatory threshold that represent the individual's energy metabolism. It should be noted that in the present invention the specific training heart rate range for a given training zone and the blood lactate concentration are obtained indirectly by the relative values of oxygen saturation. The system allows different physical training zones to be established and correlated with the ventilatory thresholds through the instantaneous measurement of blood oxygen saturation, especially based on oxygen desaturations (or changes in the rate of oxygen desaturation) during physical exercise

The determined work zone is specific to each athlete or individual who performs exercise, according to the desaturation of oxygen and correlated heart rates of each person and in each specific exercise. Additionally, the first and / or the second communication unit can wirelessly transmit a fourth signal to and / or from a third communication unit comprised in the cloud. This third communication unit is linked to a second storage unit also included in the cloud to store the fourth signal comprising the second and / or the third signal. In said cloud at least the historical data of the second and / or the third signal is stored so that the individual can consult them privately from any device with internet connection.

In a fourth aspect of the present invention, a non-invasive method is described for, from the saturation of blood oxygen and the heart rate of an individual, to determine a heart rate range capable of corresponding to a training zone for the individual during physical exercise through the system described above. More specifically, the method comprises the following stages:

· Place the non-invasive sensor on the individual's finger,

• emit, by the emitter, first signals of wavelength between 630 and 940 nm, over the area of contact with the finger,

• receive, through the receiver, corresponding second signals with a transmission of the first signals through the tissue and blood volume of the illuminated finger area,

• transmit, by wiring, these second signals to the first communication unit,

• transmit, through the first communication unit, these second signals wirelessly,

· Receive, via the second communication unit, these second signals wirelessly,

• transmit, by wiring, these second signals to the data processing unit,

• determine, from said second signals and through said data processing unit, the oxygen saturation of an arterial blood volume, the heart rate and the increase in the blood lactate concentration of the individual at the end of the exercise;

• determine, by means of said data processing unit and during the exercise, the specific training zone or heart rate range that limits them; Y

• visually or auditively represent, through the first interface, I read the corresponding training heart rate interval with a work zone for the individual, metabolic interval in which the physical exercise is developed or the maximum lactate level of the exercise. The training zones are determined based on the variations in the oxygen saturation detected.

It should be noted that when the individual is at rest, said control unit calculates a parameter corresponding to the level of baseline oxygen saturation in arterial blood that corresponds to a baseline reference of the concentration of lactate in blood volume.

Additionally, by establishing the range of heart rate values specified by the data processing unit, three training zones for physical work can be distinguished. These training zones comprise a first aerobic work zone, a second aerobic-anaerobic work zone and a third maximum work anaerobic zone from that. The passage between the first and the second training zone is detected by a first decrease in the level of blood oxygen saturation or desaturation. The passage between the second and third training zone is detected again by a second decrease in the level of saturation or desaturation. Both desaturations are related respectively to the first and second ventilatory threshold, and in turn, to a first and second increase in the concentration of lactate in blood volume.

Preferably, the determination of the heart rate is performed by a method described in the Spanish patent ES2276594. Where said method processes photoplethysmographic signals to determine the heart rate of the individual. Preferably, the determination of blood oxygen saturation is performed in the control unit by pulse oximetry of the second signals.

When, the processing unit knows the blood oxygen saturation and the value of the individual's heart rate or heart rate, it can determine the first and second ventilatory threshold according to the variations in oxygen saturation in the arterial blood volume and relates them to Lactate production aerobic and / or anaerobic work areas, which take place in an individual during the performance of progressive and intense physical exercise. The processing unit can determine the oxygen saturation values in blood calculated at each moment, and compare them with the baseline value, to calculate their variations over time and determine the desaturations that appear. At the same time, it obtains the values of the heart rate of the individual in those same moments, being able to determine what values of cardiac pulse we have in the moments in which the desaturations are registered. This process is equivalent to setting the first and second ventilatory threshold or lactic thresholds that determine the different metabolic states or training zones, which take place in an individual during the performance of progressive and intense physical exercise. Preferably, the processing unit establishes the training zones comprising a first aerobic training zone to adapt the individual to the exercise, which comprises baseline oxygen saturation values, a second aerobic-anaerobic transition training zone comprising desaturations between the 1 and 3% and a third anaerobic maximum training zone comprising desaturations greater than 3%, and which have been empirically identified with significant jumps in blood lactate concentrations.

That is, when the oxygen saturation in the blood volume decreases between 1% and 3%, the control unit detects that the individual is very close to the first ventilatory threshold, and when the oxygen saturation in the blood volume decreases More than 3%, the control unit detects that the individual is very close to the second ventilatory threshold and is capable of notifying the individual through the first or second interface. Finally, the control unit calculates the increase in lactate concentration from the calculation of the desaturation rate, or the decrease in oxygen saturation in the individual's blood volume.

In this way the individual can establish a training plan that is being monitored based on the values of the heart rate, or heart rate, correlated at any time with the variations in the oxygen saturation in his blood, obtaining a system and a method Highly accurate in measuring the heart rate and oxygen saturation in arterial blood that you can personally calculate for each individual in a more precise way your training heart rate range. DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:

Figure 1.- Shows the identification of the different parts of the system.

Figure 2a.- Shows a cross-sectional view of the non-invasive sensor (ring), dividing it into two halves across the width of the ring.

Figure 2b.- Shows a view of the longitudinal section of the non-invasive sensor (ring), dividing it into two similar halves.

Figure 3.- Shows a graph of the typical form of the variation of oxygen saturation (Sp02), heart rate (PC) and blood lactate concentration. Figure 4.- Shows a graph of the correlation between lactate concentration and oxygen saturation obtained with a pulse oximeter (Sp02).

Figure 5.- Shows a graph of the increase in lactate as a function of the slope of the decrease in oxygen saturation.

PREFERRED EMBODIMENT OF THE INVENTION

In a preferred embodiment of the invention, as shown in Figures 1, 2a, and 2b, the non-invasive system, comprising a non-invasive sensor (1) and a remote electronic device (7), determines the heart rate or Heart rate and blood oxygen saturation of an individual to establish three training zones defined by two specific values of heart rate or heart rate or / and blood oxygen saturation for said individual during physical exercise. This system establishes specific training zones from the identification of oxygen desaturations, which have been measured in an arterial blood volume flowing through a palmar digital artery itself (6) of a finger (5) of the individual. More specifically, the non-invasive sensor (1) determines the saturation of oxygen in an arterial blood volume, and the heart rate of the individual. This non-invasive sensor (1) comprises an anatomical ring intended to be placed adjacent to the tissue surrounding the blood volume of an individual's finger (5), and which in turn houses, an emitter to emit first signals, a receiver to receive second signals, a first communication unit (4) configured to receive the second signals from the receiver by cable and transmit them wirelessly and a battery to power them electrically.

More specifically, the emitter comprises a first and a second LED (2, 2 '), where the first LED (2) emits a wavelength signal of 630 or 660 nm, and the second LED (2' ) emits a signal of 850, 880, 905, 910 or 940 nm on the tissue surrounding the blood volume of the finger (5).

The receiver comprises a photodetector (3) sensitive to wavelength signals between 600 and 1000 nm, to receive the corresponding signals with a transmission of the first signals through the tissue and blood volume.

Preferably, the transmitter and the receiver are facing or almost facing each other, so that the signal emitted by the transmitter is propagated primarily by transmission by the finger (5) interacting with the tissue and at least one own palmar digital artery (6 ) of said finger (5).

The remote electronic device (7) comprises a second communication unit (9) to receive the second signals from the first communication unit (4) wirelessly, a processing unit (10), to determine, from the second signals, oxygen saturation (Sp0 ₂ ), heart rate (PC), and the increase in the lactate concentration of the individual at the end of the physical exercise as long as the latter has been carried out increasing its intensity progressively over time. The processing unit (10) may determine the PC1 and PC2 values as long as the corresponding saturation values are Sp0 ₂ b-1% and Sp0 ₂ b-3% respectively, and Sp0 ₂ b being the baseline value (at rest) of oxygen saturation before beginning physical exercise. PC1 and PC2 will be the heart rate values that define the work area for the individual. A first interface (8) that visually or auditively represents at least the value of oxygen saturation, the heart rate (or heart rate) and, if applicable, the heart rate values corresponding to PC1 and PC2 that determine the zone of work, and the increase of the lactate concentration of the individual when the physical exercise is finished.

Additionally, this remote electronic device (7) comprises a global positioning unit, not shown, to determine its location in the world, and a storage unit, not shown, linked to the processing unit (10) and the processing unit. global positioning, to store at least oxygen saturation, training zones, the increase in blood lactate of the individual or location in the world of the remote electronic device (7).

Preferably, the second communication unit (9) wirelessly transmits to the first communication unit (4) a third signal comprising: oxygen saturation, current heart rate, increasing the individual's lactate concentration and / or frequency / s cardiac / s suitable for physical exercise in the work area, and the non-invasive sensor (1) comprises a second interface capable of representing at least third signal visually or audibly.

More specifically, this second interface comprises on its external face, to facilitate its visualization by the individual, colored witnesses, where if one of these witnesses emits a green light it indicates that the individual is at rest or in the warm-up or pre-phase effort, or that baseline values of saturated oxygen are being measured. If one of these witnesses emits a yellow light it means that the individual is exercising without exceeding the second ventilatory threshold (without reaching the PC2 value), and if one of these witnesses emits a red light indicates that he has exceeded the second ventilatory threshold (values heart rate greater than PC2).

In this preferred embodiment, the correlation between oxygen saturation in the digital finger artery (5) of the user and their blood lactate concentration has been obtained from the following laboratory study with more than 21 individuals of different ages, conditions physical, sex and race. The following aspects were included in the study protocol:

a) An anamnesis by interview.

b) A physical examination: cardiovascular, pulmonary. Taking blood pressure and measuring weight and height of the individual.

c) Preparation of the individual, prior to the study.

d) Incremental maximum direct stress test on an ergometric bicycle with an electromagnetic brake or cycloergometer, with continuous electrocardiographic monitoring, together with determination of exhaled gases breath by breath, together with the performance of continuous pulse pulse oximetry, as well as various temperature, voltage taps Arterial and lactate intake invasively every 1.5 minutes.

Stress test Once the individual was prepared, and before the start of the stress test in the cycloergometer, the baseline data were taken at rest for one minute, to continue with a 3-minute warm-up in the cycle ergometer with a 25 W load and a pedaling rate of 60 revolutions per minute (rpm), after which the stress phase begins at 50 W, increasing 25 W every minute, during which the individual must maintain a pedaling rate between 60 and 70 rpm, until one of the following situations occurs: that the individual reaches exhaustion, that he himself wishes to stop the test, when criteria of maximality are reached or any data that is criteria for interrupting the test is appreciated. Recovery begins from the first minute, continuing the individual pedaling at 60 rpm and with a load equal to half of the maximum reached in the effort phase during the first minute of recovery, 50 W in the two subsequent minutes and of 25W from minute 4.

At the time of the start of the cycle ergometer test, the time begins to be timed, while the pulse oximeter and ergospirometer (continuous ECG monitoring set, and real-time gas analyzer) start measuring.

Blood pressure and temperature measurements were made every two minutes throughout the stress phase of the test.

The same effort protocol was followed for each and every individual. The The only difference between the test performed by each individual was the level of effort achieved (stage) by each of them, which varied depending on the physical capacity of each individual. Lactate intake

During the maximum stress test in the cycloergometer, for the determination of lactate, a micro-sample of blood was taken from the pulp of one of the fingers of the individual's hand, preferably the left. The shots were taken before the start of the test (during the rest period) and later, during the effort phase, every 1.5 minutes, when maximum effort is reached and during the recovery phase every 1.5 minutes, until 8 minute of it.

Two identical devices were used for blood lactate analysis, interleaved in time, in order to analyze the samples every minute and a half.

Of these 21 tests, the first 10 were dedicated to optimizing the measurement system and the test procedure; These tests were successive approximations to the optimal test conditions, and were not taken into account in the analysis presented below so as not to increase the parameters at stake uncontrollably, although they can be used as a control group for the results obtained .

Analysis of the measures and correlations It is evident that there are many variations between individual and individual at the time of testing, from the individual's genetic conditions, fitness level, mood to varying environmental conditions by temperature, humidity, etc. However, the vast majority of tests have characteristics that reproduce a typical sequential form in all the parameters that have been measured. This allows us to evaluate all the tests in general, looking at the repetitive critical points in most cases in order to correlate the different parameters measured according to the changes observed in them.

The typical form of the variation in oxygen saturation (Sp0 ₂ ), heart rate (or heart rate) and blood lactate concentration as a physiological response to stress can be seen in Figure 3, which represents a typical case (Measure P19). We have represented with a continuous line the oxygen saturation values and with open circles the measured lactate values every minute during the stress test. Heart rate values are represented by black circles. These curves show the behavioral changes of these parameters. Simply based on a visual appreciation, significant slope changes can be seen in both lactate and saturation. It is observed that these changes coincide in time in both curves (the correlation between both curves is indicated with a first and a second discontinuous and vertical thin line that crosses both the oxygen saturation values and the lactate values). Thus, three training zones are clearly differentiated: the first training zone, the second training zone and the third training zone, respectively indicated in Figure 3 as I, II and III, which mean metabolic changes in the individual. In turn in this figure 3, the first ventilatory threshold is indicated by a first vertical short line on the reference VT1, and the second ventilatory threshold by a second vertical short line on the reference VT2.

In the zone defined as the first training zone (I), the saturation measure, despite the fact that its variability is large, does not observe net variability, that is, in average terms the oxygen saturation neither rises nor falls, and is maintained at a level that depends on each individual and that corresponds to a baseline level. In turn, in this first training zone, it is observed that the lactate level is also maintained around a baseline level.

Therefore, we can think that in this time interval the oxygen consumed is that provided by the breath. There is no relevant production of lactate, and it does not accumulate in the blood. In the second training zone (II), oxygen saturation begins to fall quite clearly and in clear correlation with a slight production of lactate and with the first ventilatory threshold (VT1). In all cases it has been observed that in this second training zone the lactate level does not exceed 4-5 mmol / l, values similar to those described in publications of physiological studies. This correlation, weak decrease in oxygen saturation and mild lactate rise could be due to the fact that in this second training zone the oxygen breathed for the required effort is no longer sufficient, and the lactic anaerobic metabolic pathway, which produces a small percentage, is activated lactate

The third training zone (III) begins with a significant change in the slope of oxygen saturation, qualitatively coinciding with the appearance of the second ventilatory threshold (VT2) and in turn with the sudden rise in lactate concentration. Therefore, we have here again a correlation between the parameters.

It is in this third training zone when the oxygen consumption required to continue increasing physical exertion is such that lactate production skyrockets, producing blood concentrations above 4-5 ml / l. And the oxygen consumption is so high that saturation at the peripheral level suffers, manifesting itself in a deep desaturation and change in the slope of the descent of the oxygen saturation.

In summary, a correlation between the slope changes of the oxygen saturation descent curve (changes in saturation or desaturation speed), the appearance of the ventilatory thresholds and the increasing increase in lactate production is demonstrated.

The correlation between lactate concentration and Sp02 is also demonstrated, as can be seen in fig. 4. In this fig. 4 The lactate and oxygen saturation values are represented for all individuals, taken three specific times: one before the first inflection point of the oxygen saturation diagram (basal saturation), another around the second ventilatory threshold (second point of inflection), and one last point around the maximum of the stress test, which does not always coincide with the maximum value of the lactate concentration.

The points are scattered around the regression curve (expression thereof in the header of the graph) for high lactate values (very dependent on each individual). It seems that it is possible to predict not the lactate value absolutely (note that the uncertainty of the point cloud is relatively large), but if the lactate is in one or other of the three well-determined areas: • Basal saturation value: lactate about 1 mmol / l,

• Saturation values between 1% and 3%: lactate up to 4.5 ± 1.5 mmol / l

• Saturation values> 3%: very high lactate values and little predictable (they are very dependent on each individual).

Correlation between the rate of variation of oxygen saturation and the maximum value of lactate detected in blood.

We assume that the faster oxygen is spent in the blood, the more lactate will be produced in the third training zone (anaerobic phase), already demonstrated in several previous works. It has been shown that blood lactate increases significantly above the second ventilatory threshold (VT2) and that lactate may be affected by fitness, training and blood oxygen content.

The increase in the lactate concentration measured in each maximum stress test as a function of the slope of the oxygen saturation decrease is represented, in Figure 5. The values obtained from the linear regression performed with the experimental values of different athletes.

Claims

1. - Non-invasive sensor (1) for determining the oxygen saturation in blood and the heart rate of an individual, characterized in that said non-invasive sensor (1) comprises an anatomically circular body, such as a flexible band, ring or anatomical ring, intended to be placed adjacent to the tissue surrounding an arterial blood volume, representative of the oxygen saturation of the arterial blood, of a finger (5) of the individual, and which in turn houses:

• a transmitter to emit first signals of wavelength between 630 and 940 nm, on the tissue surrounding the blood volume of the finger

(5);

• a receiver to receive second signals of corresponding wavelength between 600 and 1000 nm with a transmission of the first signals through at least the tissue and arterial blood volume; Y

· A first communication unit (4) configured to receive the second signals from the receiver by cable and transmit them wirelessly.

2. - Non-invasive sensor (1), according to claim 1, characterized in that the transmitter comprises a first and a second signal generator, wherein said first and second signal generator generates quasi-monochromatic or monochromatic lights, and are selected among: LED diodes (2, 2 '), laser diodes, other quasi-monochromatic or monochromatic light generators, or a combination of the above.

3. - Non-invasive sensor (1) according to claim 2, characterized in that the first and second signal generator are LED diodes (2, 2 '), wherein the first LED (2) emits a signal of length wave between 630 and 780 nm; and the second LED (2 ') emits a signal between 850 and 940 nm.

4. - Non-invasive sensor (1), according to claim 1, characterized in that the transmitter comprises a first and a second generator of signals that emit alternately:

• a signal A whose wavelength is 630 or 660 nm, and a signal B whose wavelength is 850, 880, 905, 910 or 940 nm, or

5. - Non-invasive sensor (1), according to claim 1, characterized in that the transmitter and the receiver are facing each other, so that the signal emitted by the transmitter is propagated fundamentally by transmission by the finger (5) crossing at least the tissue and an own palmar digital artery (6) that contains the arterial blood volume.

6. - Remote electronic device (7), portable by an individual carrying on his finger (5) the non-invasive sensor (1) described in any one of claims 1 to 5, to determine the training heart rate range of the individual characterized in that the remote electronic device (7) comprises:

· A second communication unit (9) for receiving the second signals from the first communication unit (4) wirelessly of the non-invasive sensor described in any of claims 1 to 5,

• a processing unit (10), to determine:

• a first interface (8) to visually or auditively represent at least oxygen saturation or the maximum lactate concentration if a progressive and intense exercise has been performed.

7 - Remote electronic device (7) according to claim 6, characterized in that additionally the remote electronic device (7) comprises a global positioning unit for determining its location in the world.

8. Remote electronic device (7) according to claim 6 or 7, characterized in that additionally the remote electronic device (7) comprises a first storage unit for storing at least the oxygen saturation during the entire time in which it is performs physical exercise, the maximum lactate concentration if a progressive and intense exercise has been performed, work area, heart rate of the individual or location in the world of the remote electronic device (7).

9. - Non-invasive system to determine from the blood oxygen saturation and the heart rate at least one training zone for the individual during the

5 physical exercise from desaturation measurements characterized by the fact that the system includes:

• the non-invasive sensor (1) described in any one of claims 1 to 5; Y

• the remote electronic device (7) described in any one of claims 6 to 8.

10. - Non-invasive system according to claim 9, characterized in that the second communication unit (9) wirelessly transmits to the first communication unit (4) a third signal comprising: oxygen saturation, instantaneous heart rate, the lactate concentration of the individual and / or the training heart rate.

11. - Non-invasive system according to claim 10, characterized in that the non-invasive sensor (1) comprises a second interface capable of visually representing, or auditively, at least a third signal.

12. - Non-invasive system according to claim 10, characterized in that:

• the first and / or second communication unit (9) wirelessly transmits and / or receives a fourth signal to and / or from a third communication unit comprised in the cloud,

• the third communications unit is linked to a second storage unit comprised in the cloud to store the fourth signal, and

• said fourth signal comprises the second and / or the third signal. 0

13. A non-invasive method for determining the work area for an individual by means of the non-invasive system described in any one of claims 9 to 11, characterized in that it comprises:

• place the non-invasive sensor (1) on the individual's finger (5),

• emit, through the emitter, first signals of wavelength5 between 630 and 940 nm, on the tissue surrounding the volume blood of the finger (5),

• receive, through the receiver, corresponding second signals with a transmission of the first signals through at least the tissue and blood volume,

• transmit, by wiring, these second signals to the first communication unit (4),

• transmit, via the first communication unit (4), these second signals wirelessly,

• receive, via the second communication unit (9), these second signals wirelessly,

• transmit, by wiring, these second signals to the data processing unit (10),

• determine, from said second signals and by said data processing unit (10), the oxygen saturation of an arterial blood volume, the heart rate and the maximum blood lactate concentration of the individual at the end of the exercise,

• determining, by said data processing unit (10), a training heart rate range for the training objectives of the individual during physical exercise so that at least one frequency range is established, and

• visually or auditively represent, through the first interface (8), the corresponding training heart rate interval with a work area for the individual, metabolic interval in which the physical exercise or the maximum lactate level of the individual develops.

14. - Non-invasive method according to claim 13, characterized in that when the individual places the non-invasive sensor (1) on the finger (5) and is at rest, before starting the physical exercise, said processing unit calculates the baseline oxygen saturation level to obtain a baseline reference.

15. - Non-invasive method according to claim 13 or 14, characterized in that the work zone, determined by the data processing unit (10), establishes three specific work zones to develop different physical abilities of the individual.

16. - Non-invasive method according to claim 13, characterized in that the areas of The work includes a first aerobic work zone of adaptation to the exercise, characterized by baseline oxygen saturation values, a second aerobic-anaerobic transition work zone characterized by desaturations between 1 and 3% and a third maximum anaerobic work zone characterized by desaturations greater than 3%.