阅读说明：本技术 用于呼吸测量的方法和系统 (Method and system for respiratory measurement ) 是由 马利尼·奥利沃 古尔普里特·辛格 毕人哲 于 2018-05-15 设计创作，主要内容包括：用于测量人或动物皮肤上的呼吸振动的方法和系统,包括在皮肤上的第一位置发射发射光并在皮肤上的第二位置接收来自发射光的散射光；存储振动信号,该振动信号包括随着时间的推移接收到的散射光的光强度；其中,振动信号对应于皮肤的机械振动,并从振动信号中提取呼吸参数。该系统包括用于执行该方法的发射器和接收器。该系统包括：电路,配置为存储与一段时间内接收到的漫射光的光强度相对应的振动信号；以及处理单元,配置为从振动信号中提取呼吸参数。还提供了一组传感器模块和皮肤粘合贴片。(A method and system for measuring respiratory vibrations on the skin of a human or animal comprising emitting emitted light at a first location on the skin and receiving scattered light from the emitted light at a second location on the skin; storing a vibration signal comprising a light intensity of scattered light received over time; wherein the vibration signal corresponds to mechanical vibration of the skin and the breathing parameter is extracted from the vibration signal. The system comprises a transmitter and a receiver for performing the method. The system comprises: a circuit configured to store a vibration signal corresponding to a light intensity of the diffused light received over a period of time; and a processing unit configured to extract the breathing parameter from the vibration signal. A set of sensor modules and skin adhesive patches are also provided.)

1. A method for measuring respiratory vibrations on the skin of a human or animal comprising:

emitting emitted light at a first location on the skin;

receiving diffused light from the emitted light at a second location on the skin, wherein the second location is a distance from the first location;

storing a vibration signal comprising a light intensity of the diffuse light received over time; wherein the vibration signal corresponds to mechanical vibration of the skin; and

a breathing parameter is extracted from the vibration signal.

2. The method of claim 1, further comprising applying a low pass filter on the vibration signal.

3. The method of claim 1 or 2, further comprising generating a frequency spectrum in the frequency domain from the vibration signal in the time domain.

4. The method of any of claims 1 to 3, wherein extracting the breathing parameter comprises determining at least one of: respiratory cycle count, frequency, rate, depth, inspiratory to expiratory ratio (IER), inspiratory time, maintenance time, expiratory time, hold time, coherence, smoothness, and transitivity.

5. The method of any of claims 1 to 4, wherein extracting the respiratory parameter may include determining one or more cough events.

6. The method of any of claims 1-5, wherein extracting the breathing parameter comprises determining one or more speech events.

7. The method of any one of claims 1 to 6, wherein at least one of the first and second positions is near or at the trachea, neck or chest.

8. A system for performing the method of any of claims 1 to 7, comprising:

an emitter configured to emit the emitted light at the first location on skin;

a receiver configured to receive the diffused light from the emitted light at the second location on the skin;

wherein the second position is a distance from the first position;

a circuit configured to store the vibration signal corresponding to the light intensity of the diffused light received over time;

a processing unit configured to extract the breathing parameter from the vibration signal.

9. The system of claim 8, wherein the time is equal to or longer than at least one respiratory cycle.

10. The system of claim 8 or 9, wherein the system comprises a sensor module, wherein the sensor module comprises the transmitter and the receiver.

11. The system of claim 10, wherein the sensor module is a necklace pendant or a necklace.

12. The system of any one of claims 8 to 11, wherein the transmitter and the receiver are positioned relative to each other to face in substantially the same direction.

13. The system of claim 10 or 11, wherein the sensor module comprises the circuitry and optionally a processing unit.

14. The system of any one of claims 8 to 12, further comprising a remote device, and wherein at least one of the circuitry and the processing unit is disposed in the remote device.

15. The system of any one of claims 8 to 14, wherein the circuit and the processing unit are part of the same microprocessor circuit.

16. The system of any one of claims 8 to 15, wherein at least one of the first and second positions is near or at the trachea, neck or chest.

17. The system of any one of claims 8 to 16, wherein the emitter comprises a light emitting diode or a light emitting laser diode.

18. The system of any one of claims 8 to 17, wherein the receiver comprises a photodetector.

19. The system of any one of claims 8 to 18, wherein at least one of the transmitter and the receiver comprises a respective light guide.

20. The system of any one of claims 8 to 19, wherein the emitted light comprises a wavelength that is at least partially diffusible through skin.

21. A set of sensor modules and a skin adhesive patch,

wherein the skin-adhesive patch comprises a first surface capable of being placed on the skin and a second surface capable of cooperating with the sensor module to secure the sensor module to the patch;

wherein the sensor module includes:

an emitter configured to emit emitted light at a first location on the skin;

a receiver configured to receive diffused light from the emitted light at a second location on the skin;

wherein the second position is a distance from the first position;

a circuit configured to store a vibration signal corresponding to a light intensity of the diffuse light received over a period of time;

wherein the patch comprises a window area configured to allow optical coupling of the emitter with the skin and the receiver with the skin.

Technical Field

Aspects of the present application relate to a method for measuring respiratory vibrations on the skin of a human or animal. Aspects of the present application relate to a system for performing a method for measuring respiratory vibrations on the skin of a human or animal. Aspects of the present application relate to a set of sensor modules and a skin adhesive patch.

Background

Medical institutions worldwide still measure respiration manually by counting and timing chest movements. In clinical departments (e.g., emergency rooms and respiratory wards) that are inherently fast in pace, large in patient volume, or require more accurate measurements, methods of manually calculating breathing can be slow, laborious, and subjective. While techniques such as Electrocardiogram (ECG) and Capnography (CPG) have been explored to more objectively monitor respiration, they are not adequate to prime the patient and system and prolong the time of connection to the patient due to the long setup time. Furthermore, such ECG/CPG-based solutions can be expensive and often adequate for patients in highly dependent units, and deployment in remote environments may be impractical. Already available solutions for measuring respiration in a clinical environment are those based on electrical, acoustic and capnography (capnography). The major bottleneck in such techniques is that they are generally not available to patients, especially in large clinical settings such as emergency treatment, and they are cumbersome and inefficient to use. They require a long setup time and the patient's activities are limited.

Accordingly, there is a need to provide a convenient and accurate method and apparatus for respiratory measurements.

Disclosure of Invention

Various embodiments may provide a method for measuring respiratory vibrations on the skin of a human or animal. The method can comprise the following steps: emitting emitted light at a first location on the skin and receiving diffused light from the emitted light at a second location on the skin. The second position is at a distance from the first position. The method may include storing a vibration signal, which may include the light intensity of the diffuse light received over time. The vibration signal may correspond to mechanical vibrations of the skin. The method may comprise extracting a breathing parameter from the vibration signal.

Various embodiments may provide a system that performs a method according to the present disclosure. The system may include a transmitter and a receiver, the transmitter may be configured to transmit emitted light at the first location on the skin. The receiver may be configured to receive diffused light from the emitted light at the second location on the skin. The second position is at a distance from the first position. The system may include a circuit. The circuit may be configured to store a vibration signal corresponding to the light intensity of the diffuse light received over a period of time. The system may comprise a processing unit, which may be configured to extract a breathing parameter from the vibration signal.

Various embodiments may provide a set of sensor modules and skin adhesive patches. The skin adhesive patch may include a first surface that may be placed on skin and a second surface that may cooperate with the sensor module to secure the sensor module to the patch. The sensor module may include a transmitter and a receiver. The emitter may be configured to emit the emitted light at the first location on the skin. The receiver may be configured to receive diffuse light from the emitted light at the second location on the skin. The second position is at a distance from the first position. The sensor may include circuitry. The circuit may be configured to store a vibration signal corresponding to a light intensity of the diffuse light received over a period of time. The skin adhesive patch may include a window region configured to allow optical coupling of the transmitter to the skin and optical coupling of the receiver to the skin.

Drawings

The invention will be better understood with reference to the detailed description when considered in conjunction with the non-limiting examples and the accompanying drawings, in which:

FIG. 1 shows a flow diagram of a method 100 according to various embodiments;

FIG. 2 is a schematic diagram of a system 200 and a skin section 14 on which a transmitter 220 and a receiver 230 for measuring respiratory vibrations are placed, according to various embodiments;

FIG. 3 is a schematic diagram of a system 300 according to some embodiments, wherein optical fibers 322 and 332 contact skin 10 over neck region 20;

FIG. 4A shows a graph of a time varying vibration signal 410 in the form of a receiver output acquired with the system 300 shown in FIG. 3;

FIG. 4B shows a spectrum 420 of a Fast Fourier Transform (FFT) of signal 410;

FIG. 5 is a schematic view of a system 500 on skin 10 around neck region 20, according to some embodiments, in which the optical emitter and optical receiver may be in close contact with the skin, thus eliminating the need for optical fibers;

FIG. 6A shows a graph of a vibration signal 610, the vibration signal 610 varying with time in the form of an output of a receiver, acquired using the system 500 of FIG. 5, in accordance with various embodiments;

FIG. 6B shows a spectrum 620 of a Fast Fourier Transform (FFT) of the signal 610;

fig. 7A shows a graph of a vibration signal 700 representing respiration and cough events 720 and 730 in region 710.

Fig. 7B shows a graph of vibration signal 750 representing the breath conditioned by speech in region 760.

Fig. 8A illustrates an assembled kit of a sensor module 860 and a skin adhesive patch 870 applied to a person's neck 20, in accordance with various embodiments.

Fig. 8B shows a close-up view of the assembled kit of the sensor module 860 and the skin adhesive patch 870 of fig. 8A, with the adhesive protective layer 872 partially removed.

Fig. 8C shows a close-up view of the skin adhesive patch 870 and sensor module 860 of fig. 8A and 8B in an unassembled state.

Fig. 9A is a schematic diagram of an assembled kit 900 of a sensor module 960 and a skin adhesive patch 970.

Fig. 9B is a cross-sectional view a-a of the assembly kit 900 for illustrating an example of the window region 974.

Fig. 10 shows an upper graph 1010 and a lower graph 1020 of the vibration signal, in which the breathing frequency can be seen over a continuous time of 3 minutes.

Fig. 11 illustrates a comparison of a respiration rate signal acquired in the lower curve with a respiration rate signal acquired with a commercial product using a different technique in the upper curve 1110, in accordance with various embodiments.

Fig. 12 shows an example of a schematic layout of electronic components of a sensor module 1200 according to various embodiments.

Detailed Description

The following detailed description refers to the accompanying drawings that show, by way of illustration, specific details and embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized and structural and logical changes may be made without departing from the scope of the present invention. The various embodiments are not necessarily mutually exclusive, as some embodiments may be combined with one or more other embodiments to form new embodiments.

Embodiments described in the context of methods may similarly be valid for the system, and vice versa. Similarly, embodiments described in the context of a system may similarly be valid for a set of sensor modules and skin adhesive patches, and vice versa. Moreover, embodiments described in the context of a method may similarly be valid for a set of sensor modules and skin adhesive patches, and vice versa.

Features described in the context of one embodiment may be correspondingly applicable to the same or similar features in other embodiments. Features described in the context of an embodiment may be correspondingly applicable to other embodiments, even if not explicitly described in these other embodiments. Furthermore, additions and/or combinations and/or alternatives for features as described in the context of the embodiments may be correspondingly applied to the same or similar features in other embodiments.

The articles "a," "an," and "the" are used in the context of various embodiments to include reference to one or more features or elements.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Various embodiments may provide a method for measuring respiratory vibrations on human or animal skin. According to various embodiments, the term "respiratory vibrations" may refer to mechanical vibrations caused by the respiratory tract on the skin (e.g., the lower surface of the skin). One example of generating respiratory vibrations is breathing.

According to various embodiments, the method may comprise: a first location on the skin emits emitted light and a second location on the skin receives diffused light from the emitted light. The second position is at a distance from the first position. The distance may be selected from 2mm to 20mm, for example 5mm to 15 mm. Exemplary distances are 5mm and 10 mm. The distance may be measured as the distance between the center of light emission at one end of the transmitter (which end is positioned at the proximal end of the skin) and the center of light detection at one end of the receiver (which end is positioned at the proximal end of the skin).

The method may include storing a vibration signal corresponding to the light intensity of the diffuse light received over time.

According to various embodiments, the term "vibration signal" may denote an electronic form of the received signal corresponding to mechanical vibrations of the skin, wherein the mechanical vibrations of the skin may comprise a respiratory vibration signal. The plurality of light intensity values obtained over time may comprise or may form a vibration signal. For example, the light intensity may be received by a receiver (e.g., a photodiode), and the time-varying electrical signal from the photodiode may be considered a vibration signal. In another example, the intensity of light received by the receiver (e.g., by a photodetector or photodiode) may be converted from analog to digital form and may further be stored in memory. A plurality of light intensity values stored in digital form over time may form a vibration signal in digital form.

Surprisingly, the vibration signal is due to mechanical vibrations, e.g. along the neck or near the trachea around the chest, which are caused by breathing. The respiration-induced vibration signal obtained in various embodiments is actually much stronger than other optical-based methods, such as photoplethysmography (PPG). PPG methods are commonly used in pulse oximeters and smart watches to measure the heart rate at the extremities of the human body and may indirectly infer the respiration rate. Although respiration can also be inferred by pulse oximetry, this method is indirect and not accurate for clinical work. Accordingly, pulse oximeter devices are configured for use at the extremities of the body where PPG signals may be acquired, respectively. In contrast, the method of the present disclosure takes advantage of the fact that, upon breathing, the membrane beneath the skin of the tracheal region expands and contracts. Due to the expansion and contraction, the light absorption changes, and therefore, the diffusely reflected light signal (diffused light) carrying the vibration signal also changes. The vibration signal has a pattern corresponding to the respiration rate. In practice, it has been found that the breathing modulation can be observed from the raw analog signal measured at the receiver. The method according to various embodiments is more direct and may be more accurate than other optical-based methods, as it does not necessarily require any form of additional signal processing technique to observe the breathing rate (note that calculating the breathing rate from the PPG is an indirect method). Furthermore, it may also be remote from measurements of the limb, such as the arm, finger or other areas, which are typical areas for measuring PPG-based respiratory rate — some of which may be of interest, particularly in terms of user experience. It is noted that the measured vibration signal is not the PPG signal, but a signal generated by mechanical vibrations of the skin.

Surprisingly, the method and system used herein can obtain very accurate breathing information in a simple manner.

According to various embodiments, the method may comprise extracting the breathing parameter from the vibration signal. According to various embodiments, the breathing parameter may be: respiratory cycle count, frequency or rate, depth, inspiratory to expiratory ratio (IER), inspiratory time, maintenance time, expiratory time, hold time, coherence, smoothness, and transitivity. For example, the breathing parameter may be a breathing frequency or a breathing cycle count. Accordingly, extracting the breathing parameter may include determining at least one of a breathing frequency and a breathing cycle count. The breathing parameter may be a breathing parameter of the periodic signal. For example, the breathing parameters: respiratory cycle count, frequency or rate, depth, inspiratory to expiratory ratio (IER), inspiratory time, maintenance time, expiratory time, hold time, coherence, smoothness and transitivity may be respiratory parameters of the periodic signal.

According to various embodiments, the method may further comprise applying a low pass filter on the vibration signal. A low-pass filter may be applied to the vibration signal in order to determine a breathing parameter, in particular of the periodic signal. The low pass filter may be an electronic analogue filter for filtering the vibration signal in analogue form, for example, prior to conversion in digital form. Alternatively or additionally, the low pass filter may be a digital filter for filtering the vibration signal in digital form. For example, the low pass filter may have a cut-off frequency of 1Hz or 0.8 Hz. The cut-off frequency may be a-3 dB half-power point. It has been found that a better signal-to-noise ratio can be obtained, in particular for determining breathing parameters, using a low-pass filter.

According to various embodiments, the term "breathing", for example in "counting of breathing cycles", may refer to the cycle of air entering the lungs and then being expelled.

According to various embodiments, the method may comprise generating a frequency spectrum in the frequency domain from the vibration signal in the time domain. For example, an FFT transform may be applied to the vibration signal to obtain a frequency spectrum. In one example, the breathing frequency may be obtained from a frequency corresponding to a peak in the spectrum. For example, for human breathing, the breathing rate may be obtained between 0.15Hz and 1Hz, for example between 0.2 and 0.8 Hz. The respiration rate can be calculated directly from the respiration rate.

In addition to monitoring the breathing of a person, the proposed method may also be used for monitoring coughing and/or speech of a person. When a person coughs, a spike can be observed from the output of the photodetector. Similarly, when a person speaks, the breathing signal is modulated and can be observed from the output of the photodetector. By tracking such respiratory behavior, the proposed method can be used to track: 1) respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD), 2) sleep disorders such as obstructive sleep apnea, 3) stress and health, 4) voice communication and 5) fitness performances.

According to various embodiments, a method according to various embodiments may include isolating signals having a frequency range between 0.15Hz and 1Hz (e.g., between 0.2 and 0.8 Hz).

According to various embodiments, the respiratory parameter may be a cough event or a cough event count. Accordingly, extracting the respiratory parameter may include determining one or more cough events. For example, a cough event is characterized by an amplitude that is higher than the average breath-absorbing amplitude, e.g., 2 times or more, and a duration that is shorter than the average respiratory cycle, e.g., one-half, one-third, or less. A strong signal was found for a cough event. Thus, if a low pass filter is provided, a cough event may also be detected from the vibration signal before the low pass filter.

According to various embodiments, the breathing parameter may be a speech event or information related to a speech event. Accordingly, extracting the breathing parameters may include determining one or more speech events. The speech may be filtered from the vibration signal by a speech filter. The speech filter may be a band pass filter, for example with a band pass between 100Hz and 17 kHz. Thus, speech can be easily distinguished from other breathing parameters, in particular from breathing parameters of the periodic signal.

Various embodiments may provide a system for performing a method according to the present disclosure.

In the context of the present disclosure, and according to various embodiments, the term "system" may refer to a system implemented as a device. For example as a device that the user may wear, for example in the neck region of the user.

According to various embodiments, the emitter may be configured to emit the emitted light at a first location on the skin. According to various embodiments, the emitter may comprise a light emitting device, such as a light emitting diode or a light emitting laser diode. The emitter may comprise a light guide, such as an optical fibre. The optical fiber may be optically coupled to the light emitting device. The emitter may be configured to emit light having a peak wavelength selected from 600nm to 1000nm, for example selected from 800nm to 900 nm. Accordingly, the light emitting device may be configured to emit light having a peak wavelength selected from 600nm to 1000nm, for example selected from 800nm to 900 nm. The light emitting device may be, for example, a laser diode, such as a Vertical Cavity Surface Emitting Laser (VCSEL). In one example, the light emitting device may be a VCSEL850nm laser diode. In another example, the emitter may be a VCSEL850nm laser diode coupled to a light guide. It has been found that a good signal-to-noise ratio can be obtained for the vibration signal using a laser diode. It was also found that the vibration signal is more intense in the wavelength range between 800nm and 1000nm, including the wavelength range 800nm to 900 nm.

According to various embodiments, the receiver may be configured to receive diffuse light from the emitted light at a second location on the skin. According to various embodiments, the receiver may comprise a light detector, for example a photodetector, such as a photodiode or a phototransistor. The photodetector may include biasing and/or amplifying circuitry. The receiver may comprise a light guide, such as an optical fibre. The optical fiber may be optically coupled to a light detector. The receiver may be configured to sense light at a peak wavelength of the transmitter. In one example, the receiver may be a broadband photodiode (e.g., wavelength range between 600nm to 1000nm) covering VIS-NIR. In another example, the receiver may be a broadband photodiode covering VIS-NIR (e.g., wavelength range between 600 to 1000nm) coupled to the light guide. In yet another example, the receiver may be configured to respond to wavelengths of 800nm to 900nm, and may have less or no responsiveness outside this range.

According to various embodiments, the transmitter and the receiver may be configured such that when the transmitter and the receiver are located on the skin, the transmitter is arranged to transmit the emitted light at a first location on the skin and the receiver is configured to receive the diffused light from the emitted light at a second location on the skin. The second position is at a distance from the first position.

According to various embodiments, the transmitter and receiver may be in close contact with the skin, e.g. in direct contact. Accordingly, the transmitter and receiver may be configured to be in close contact, e.g. direct contact, with the skin. The term "close" in "close contact" may mean that the separation between the emitter and the skin and/or the receiver and the skin is less than the distance between the first and second positions, e.g., less than 1/10 of the distance or less than 1/20 of the distance. For example, the spacing may be between 2 and 5mm, in another example, the spacing may be equal to or less than 5mm, in another example, the spacing may be less than 2 mm.

According to various embodiments, the emitted light may comprise a wavelength that is capable of at least partially diffusing through the skin. The wavelength of the emitted light can be adjusted to enable measurement of the diffusion path length in the skin. The wavelength may be in the range of 600nm to 1000nm, such as 800nm to 900 nm. According to various embodiments, a range described as from a first endpoint to a second endpoint may include the first endpoint and the second endpoint.

According to various embodiments, the transmitter and the receiver are configured to be positioned relative to each other, or to face substantially the same direction relative to each other. In this context, the term "face" refers to the side of the optically effective receiver and transmitter. For example, the transmitter can emit light in a transmitter preferential direction and the receiver can receive light from a receiver preferential direction, the transmitter preferential direction and the receiver preferential direction being substantially parallel. For example, the transmitter and receiver may be arranged substantially in the same plane and facing away from the same side of the plane.

According to various embodiments, at least one of the first position and the second position is near the respiratory tract, for example near the trachea, along the neck or near the chest. The vibration signal was found to have a stronger intensity in these regions.

According to various embodiments, the system may include a sensor module, wherein the sensor module includes a transmitter and a receiver. The sensor module may include a housing. The transmitter and receiver may be arranged in a fixed position relative to the housing of the sensor module.

According to various embodiments, the sensor module may be a necklace pendant. Alternatively or additionally, the sensor module may be a necklace. The necklace may be, for example, a band, chain or rope which may be wrapped around the neck. The necklace pendant may be, for example, a pendant that may be attached to, for example, hang on a necklace.

According to various embodiments, the sensor module may include a communication interface configured to transmit the vibration signal to a remote device.

According to various embodiments, the time may be equal to or longer than at least one breathing cycle, for example the time may be at least 10 seconds, or in another example at least 5 seconds.

According to various embodiments, the system may include circuitry. The circuit may be configured to store a vibration signal corresponding to the intensity of light of the diffuse light received over a period of time. According to various embodiments, the system may comprise a processing unit. The processing unit may be configured to extract the breathing parameter from the vibration signal.

According to various embodiments, the system may further comprise a remote device. The sensor module may be configured to transmit the vibration signal to a remote device. The remote device may be configured to receive the vibration signal from the sensor module. In some embodiments, the processing unit may be located in a remote device. Also, the processing unit may be provided in a remote device. For example, the remote device may be a computing device, such as: computers, mobile phones, electronic tablets.

According to various embodiments, the circuit and the processing unit may be part of the same microprocessor. For example, the circuit and the processing unit may be implemented as sub-circuits of a microprocessor and/or as programmed parts at least temporarily stored in a memory which may be comprised in the microprocessor.

The present disclosure relates to an optical method of directly measuring respiration (e.g., human respiration) by direct contact. Respiration is an information-intensive data stream: it has many components such as rate, depth, inspiratory to expiratory ratio (IER), inspiratory, sustained, expiratory and sustained duration, consistency, smoothness and transitivity, etc. Fig. 1 shows a flow diagram of a method 100 according to various embodiments. A first step 110 may include emitting the emitted light at a first location on the skin and receiving diffused light from the emitted light at a second location on the skin. A second step 120 may include storing a vibration signal corresponding to the light intensity of the diffuse light received over time. A third step 130 may include extracting a breathing parameter from the vibration signal.

The principle behind this method is optical diffuse reflection. In this method, light is emitted from an emitter, referred to as emitted light or incident light (I)₀). The emitted light impinges the tissue of the skin surface at a first location and is diffused over a path having a path length L (see fig. 2, path 240) towards a receiver at a second location, which collects the diffused light (I)_r). The diffuse light may also be referred to as reflected light. The relationship between the diffused light and the emitted light is expressed by Beer-Lambert Law (Beer-Lambert Law):

I_r＝I₀e^-αL

the important part of the above relationship is the Net Path Coefficient (Net Path Coefficient) or α L (alpha x L), where α (alpha) is the Path loss Coefficient (in units of 1/cm) and L is the Path length (cm). Due to tissue vibrations during breathing, also referred to herein as breathing vibrations, the net path coefficient changes, resulting in changes and oscillations of the diffuse light (Ir) over time. The detection element absorbs this change in scattered light intensity, thereby generating a respiration signal.

Fig. 2 is a schematic view of a system 200 and a skin cross-section 14 on which a transmitter 220 and a receiver 230 are placed to measure respiratory vibrations. The emitter 220 may be configured to emit emitted light at a first location 222 on the skin. The receiver 230 may be configured to receive diffuse light from the emitted light at a second location on the skin 232. The second position 232 is a distance D from the first position 222. The light diffusion path is schematically illustrated by path 240. The length of path 240 may be approximately distance D. The length of the path along which the light passes through the skin may be, for example, 10mm, within a depth of, for example, up to 5 mm. According to various embodiments, the system is configured such that light is received from the dermal layer 16. Below the dermis layer is a subcutaneous fat layer 18, the blood concentration is typically high. According to various embodiments, the vibration signal may be a signal derived from mechanical vibrations of the dermal layer 16, and signals from lower layers (e.g., layer 18) may be further excluded to avoid an increase in signal noise. The system, transmitter and/or receiver may be configured accordingly to obtain the vibration signal from the dermis. Without being bound by theory, it is believed that the vibration signal of the dermis-modulated light may have a higher signal-to-noise ratio as the vibration signal of other skin layers.

Fig. 3 is a schematic view of a system 300 positioned on skin 10 around neck 10 according to some embodiments. The system may be implemented in the form of a fiber-coupled device that includes optical fibers (322 and 332) that contact the skin, for example, as shown in fig. 3, at locations 326 and 336. In the example of fig. 3, the transmitter includes an optical transmitter 324 and an optical fiber 322 as a light guide, and the receiver includes an optical receiver 334 and an optical fiber 332 as a light guide. In a more specific example according to fig. 3, the optical fiber 322 is placed at a first location 326 on the neck region 20. Optical fiber 332 is placed at a second location 336 on neck region 20. The optical fiber 322 is coupled to a light emitting diode 324 having a peak emission wavelength of 850 nm. The optical fiber 332 is coupled to a silicon avalanche photodiode 334. The electrical signal resulting from the interaction of light on the photodiode is post-processed by passing the electrical signal through a low pass filter and computing a Fast Fourier Transform (FFT). One example of an electrical signal is a photocurrent of a photodiode, and another example is a corresponding voltage, e.g., a voltage resulting from the photocurrent flowing through a resistor. Conversion from an analog signal to a digital signal may be included as desired, for example before the FFT, or before the low pass filter if the low pass filter is a digital filter. Fig. 4A and 4B show post-processing results obtained with the system shown in fig. 3. Fig. 4A shows a graph of a vibration signal 410 acquired with the system 300 in the form of a receiver output over time, i.e. a time domain vibration signal, which in this example comprises a clear breathing signal under normal breathing conditions. In the respiration signal, a periodic intensity modulation of the respiration rate can be seen. The FFT 420 of the vibration signal 410 is shown in FIG. 4B, where the fundamental respiratory frequency at 0.21Hz (peak 422) and the second harmonic at 0.4Hz (peak 424) are seen. This correctly corresponds to a breathing cycle of about 4.76 seconds and about 12.6 breaths per minute. According to various embodiments, a low pass filter may be used to filter out second or higher harmonics, e.g., peaks 424 as shown in FIG. 4B.

Fig. 5 is a schematic view of a system 500 located on skin 10 around neck 20 according to some embodiments. In the example of fig. 5, the transmitter 520 comprises an optical transmitter and the receiver 530 comprises an optical receiver. The system 500 may be implemented as a direct contact device, for example, where the optical emitter and the optical receiver may each be configured to be in intimate contact with the skin, and may each be in intimate contact with the skin.

Fig. 6A shows a graph of a vibration signal 610, in the form of a receiver output over time, obtained using the system 500 of fig. 5, i.e. a graph of a time domain vibration signal, which in this case comprises a clear breathing signal. An FFT 620 of the vibration signal 610 is shown in fig. 6B, where the fundamental respiratory rate can be seen at a peak 624 of 0.21 Hz. The results of FIGS. 6A and 6B were acquired using a VCSEL850nm laser diode as the emitter and a broadband photodiode detector covering the VIS-NIR (600-1000nm) as the receiver. The distance between the 850nm diode and the receiver is 10 mm.

In fig. 7A, an example of a vibration signal 700 is presented in region 710, followed by 2 coughs and 3 coughs, in the case of normal breathing. The post-processing signals are acquired using the system according to fig. 5, but similar results may be obtained using any other system according to various embodiments (e.g., the system according to fig. 3). Two distinct peaks were observed in 2 coughs in region 720, while three distinct peaks were observed in 3 coughs in region 730. Fig. 7B shows a graph representing the vibration signal 750 of the breath modulated by the speech of "Hello World" and "Good riding".

According to various embodiments, the system may be implemented as a device, such as a wearable device. The device can quickly, easily and accurately measure the breathing rate and breathing pattern around the neck of a human body. Applications of the device include clinical breath monitoring and general consumer healthcare, e.g. measuring pressure levels by breathing patterns. More system and device embodiments and examples are shown in connection with figures 8A-8C.

In the examples shown in fig. 8A, 8B, 8C, 9A, 9B, 10, 11 and 12, a system implemented as a device is used, for example, where all electronic and optical components may be integrated into a wearable device.

Fig. 8A illustrates an exemplary kit of a sensor module 860 and a skin adhesive patch 870 according to various embodiments, which is applied to a person's neck 20 in an assembled form. A skin adhesive patch may be provided to attach the device to the neck of the subject. The sensor module 860 may be assembled to the skin adhesive patch 870 by suitable fastening means, such as by hook and loop fasteners. In one example, one side of the skin adhesive patch is an adhesive portion that adheres to the subject's neck region, and the other side of the skin adhesive patch may include a hook and loop fastener that adheres to the sensor module. Fig. 8B shows a close-up view of the assembled kit of sensor module 860 and skin adhesive patch 870 of fig. 8A, still with adhesive cover 872 removed. Fig. 8C shows a close-up view of the skin adhesive patch 870 and sensor module 860 of fig. 8A and 8B in an unassembled state. The skin adhesive patch 870 may include a window area window 874 configured to allow optical coupling of the emitter to the skin and the receiver to the skin. The window area may be, for example, a transparent window or a cutout, which allows the emitted light from the sensor module to contact the subject and detect the diffused light. The skin adhesive patch may be disposable and may therefore be discarded after use.

Fig. 8A highlights how a system according to some embodiments is worn around the neck region. In other embodiments, the sensor module may be worn as a necklace pendant.

Fig. 9A is a schematic diagram of an assembled kit 900 of a sensor module 960 and a skin adhesive patch 970. The skin patch 970 may include an adhesive layer 972, the adhesive layer 972 configured for adhering the skin adhesive patch 970 to the skin. The kit may include a fastening device 976 for removably fastening the sensor module 960 to the skin adhesive patch 970. The fastening means 976 may be, for example, a single layer or more than one layer, and may be, for example, hook and loop fasteners.

Fig. 9B is a cross-sectional view a-a of the assembly kit 900 for illustrating an example of the window region 974. In the example shown, the skin adhesive patch 970 includes a window for providing a window area 974, which may be an incision or a transparent area. The window region 974 may also be devoid of the adhesive layer 972 and may be devoid of the fastening means 976.

While fig. 8A-9B describe various embodiments in connection with a set of sensor module 860 and skin adhesive patch 870, it is emphasized that the explanation and description of features also applies to systems and vice versa and to methods and vice versa according to various embodiments.

The gold standard for measuring respiration in a clinic or hospital is by manual counting. By conducting the study, the following table compares the respiration rates measured by the systems according to various embodiments with the gold standard for manual counting. This study consisted of healthy subjects of extensive age. It can be seen that the deviation can be less than 1bpm (bpm representing breaths per minute).

Subjects (age, sex, weight, skin color)	Manual (bpm)	Equipment (bpm)
			A (34, male, normal, black)	9	8.5
B (27, male, normal, white)	7	6.5
			C (64, female, overweight, white)	10	10.5
D (59, male, normal, white)	10	10.2
			E (31, male, normal, white)	14	13.4

The patients in the intensive care unit were also subjected to concept verification. One example of a comparison of the results of the golden standard (manual counting) with the results of the methods and systems according to various embodiments is shown in fig. 10. The upper graph 1010 and the lower graph 1020 of the vibration signal are shown, where the breathing frequency can be seen over a continuous time of 3 minutes. Curve 1020 shows the landing or breathing depth. This is measured as the displacement between the maximum and minimum values of the electrical signal. It can be seen that the rise and fall depth and breathing pattern are consistent throughout the breathing process. Fig. 10 shows an exemplary graph of breathing frequency over a continuous time of 3 minutes, compared to manual counting at 1 minute intervals. Manual counts were 21 counts labeled at 2 minutes, 22 counts labeled at 3 minutes, and 21 counts labeled at 4 minutes. In this study, the mean deviation from manual counting and electrocardiogram leads was 1.54bpm and 1.21bpm for critically ill patients, respectively.

Fig. 11 shows a comparison of respiration rate signals acquired in the lower curve 1120 and in the upper curve 1110 using a different technique, using commercial products (Zephyr Bioharness from Medtronic, inc.) according to various embodiments. As can be seen from fig. 11, the breathing pattern over time, matches well with commercial products.

The results of FIGS. 10 and 11 use a VCSEL850nm laser diode as the emitter and a broad band photodiode detector covering the VIS-NIR (600-1000nm) as the receiver. The distance between the 850nm diode and the receiver is 10 mm.

The sensor module may include a single chip that performs various tasks, such as at least one of power, switching module, calibration module, optical sensing, signal processing, signal transmission, wireless bluetooth transmission, or a combination thereof.

In one example, the sensor module includes several components as shown in FIG. 12. For example, on the first side 1210, the sensor module 1200 may include at least one of: a battery 1211 (e.g., a 180mAh battery), a wireless transmitter 1212 (e.g., a bluetooth transmitter), charging circuitry (e.g., a USB charging connector and/or circuitry 1214), a voltage tuner 1213 for tuning the power of the transmitter. For example, on the second side 1220, the sensor module 1200 may include at least one of: a transmitter 1221 (e.g., an LED or laser diode), a receiver 1222 (e.g., an integrated photodiode), a microprocessor 1223 (e.g., a programmable microprocessor), a memory 1224 (e.g., a 32MB memory), a switch 1225 (e.g., for turning the device on and off). The microprocessor may be configured to perform the required analog to digital conversion and signal processing. The memory may be configured, for example, to store relevant startup software data and past history. Wireless transmitters, such as bluetooth transmitters, may be configured to wirelessly receive and transmit data to mobile platforms such as computers and mobile phones.

While the invention has been particularly shown and described with reference to a particular embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the scope of the invention as defined by the appended claims. The scope of the invention is, therefore, indicated by the appended claims, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.