阅读说明：本技术 在临床条件下监测氧饱和度水平的设备 (Device for monitoring oxygen saturation level in clinical condition ) 是由 M·A·帕蒂尔 于 2020-03-04 设计创作，主要内容包括：一种氧饱和度监测器(10)包括具有相对的第一夹具部分(14)和第二夹具部分(16)的夹具(12)。光源(18)的阵列被设置在第一夹具部分上。每个光源能够在以下各项之间进行切换：(i)关闭,(ii)发射第一波长或光谱范围的光,(iii)发射不同于所述第一波长或光谱范围的第二波长或光谱范围的光,以及(iv)发射第一和第二波长或光谱范围两者的光。光探测器(20)的阵列被设置在第二夹具部分上以面向光源的阵列。光探测器的阵列中的每个光探测器被对准以探测来自光源的阵列中的对应光源的发射光。(An oxygen saturation monitor (10) includes a clamp (12) having opposing first (14) and second clamp portions (16). An array of light sources (18) is disposed on the first clamp portion. Each light source is switchable between: (i) off, (ii) emit light of a first wavelength or spectral range, (iii) emit light of a second wavelength or spectral range different from the first wavelength or spectral range, and (iv) emit light of both the first and second wavelengths or spectral ranges. An array of light detectors (20) is disposed on the second clamp portion to face the array of light sources. Each light detector in the array of light detectors is aligned to detect emitted light from a corresponding light source in the array of light sources.)

1. An oxygen saturation monitor (10), comprising:

a clamp (12) having opposing first (14) and second (16) clamp portions;

an array of light sources (18) disposed on the first clamp portion, each light source being switchable between: (i) off, (ii) emit light of a first wavelength or spectral range, (iii) emit light of a second wavelength or spectral range different from the first wavelength or spectral range, and (iv) emit light of both the first wavelength or spectral range and the second wavelength or spectral range;

an array of light detectors (20) arranged on the second clamp part to face the array of light sources;

wherein each light detector in the array of light detectors is aligned to detect emitted light from a corresponding light source in the array of light sources.

2. The oxygen saturation monitor (10) according to claim 1, wherein the first wavelength or spectral range is red light and the second wavelength or spectral range is infrared light; and the oxygen saturation monitor further comprises an electronic processor (22) programmed to:

controlling the array of light sources (18) to emit switched red and infrared light by a single active light source (18.1-18.9) in the array of light sources, while all other light sources in the array of light sources are off;

detecting the switched red and infrared light using photodetectors (20.1-20.9) in the array of photodetectors (20) aligned to detect emitted light from the single active light source emitted from the corresponding central light source; and is

Ambient light is detected using light detectors (20.1-20.9) of the array of light detectors other than the light detector aligned to detect emitted light from the single active light source.

3. The oxygen saturation monitor (10) according to claim 2, wherein the electronic processor (22) is further programmed to:

calculating a red light intensity/infrared light intensity ratio for the detected switched red and infrared light;

correcting the red light intensity/infrared light intensity ratio based on the detected ambient light; and is

The corrected red light intensity/infrared light intensity ratio is converted into an oxygen saturation value.

4. The oxygen saturation monitor (10) according to claim 3, wherein the electronic processor (22) is programmed to correct the red light intensity/infrared light intensity ratio by operations including:

calculating a correction factor (κ) from the ambient light detected by the photodetectors (20.1-20.9) of the array of photodetectors (20) other than the photodetector aligned to detect the emitted light from the single active light source (18.1-18.9), the correction factor being scaled based on euclidean distances (β) of the respective detectors from the photodetectors aligned to detect the emitted light from the single active light source; and is

Correcting the red light intensity/infrared light intensity ratio by subtracting the correction factor from the red light intensity/infrared light intensity ratio.

5. The oxygen saturation monitor (XX) according to claim 4, wherein the correction factor is:

κ＝∑_jα_jβ_jI_j

wherein the content of the first and second substances,

where κ is the correction factor, α is a contribution factor for detector j, β is detection of the detector j and receipt of red and infrared light from corresponding light sources (18.1-18.9)Euclidean distances between the devices (20.1-20.9), and λ_iIs the wavelength of light, and I_st1And I_st2Is the light intensity measured without any light source operating for a given corresponding detector.

6. The oxygen saturation monitor (10) according to any one of claims 2-5, wherein the electronic processor (22) is further programmed to:

correcting the red light intensity/infrared light intensity ratio based on the detected ambient light using a machine learning model.

7. The oxygen saturation monitor (10) according to any one of claims 1-6, wherein both the array of light sources (18) and the array of light detectors (20) are arranged in a 3x3 matrix.

8. The oxygen saturation monitor (10) according to any one of claims 1-7, further including:

at least one motion sensor (24, 26) configured to measure movement of at least one of the first and second clamp portions (14, 16); and

at least one electronic processor (22) programmed to determine an oxygen saturation value based at least on the first wavelength or spectral range and the second wavelength or spectral range of light output by the array of light sources and measured by the array of photodetectors and also based on the detected movement.

9. An oxygen saturation monitor (10), comprising:

a clamp (12) having opposing first (14) and second (16) clamp portions;

an array of light sources (18) disposed on the first clamp portion;

an array of photodetectors (20) disposed on the second clamp portion;

at least one motion sensor (24, 26) disposed on at least one of the first and second clamp portions and configured to detect motion data of at least one of the first and second clamp portions;

at least one electronic processor (XX) programmed to:

receiving red light data, infrared light data, and ambient light data detected by the light detector;

receiving movement data from the at least one motion sensor;

correcting the received light data to eliminate the detected ambient light and to compensate for the motion data; and is

An oxygen saturation signal is calculated from the corrected light data.

10. The oxygen saturation monitor (10) according to claim 10, wherein the at least one motion sensor (24, 26) includes:

an accelerometer (24) configured to measure a displacement of at least one of the first clamp portion (14) and the second clamp portion (16); and is

A gyroscope (26) configured to measure rotation of at least one of the first and second clamp portions.

11. The oxygen saturation monitor (10) according to either one of claims 9 and 10, wherein the accelerometer (24) is disposed in the first clamp portion (14) and the gyroscope (26) is disposed in the second clamp portion (16).

12. The oxygen saturation monitor (10) according to any one of claims 10-12, wherein the at least one electronic processor (22) is programmed to:

determining a first displacement value from displacement data measured by the accelerometer (24);

determining a second displacement value from rotation data measured by the gyroscope (26); and is

An oxygen saturation value is calculated from a sum of the displacement values.

13. The oxygen saturation monitor (10) of claim 12, wherein:

the first displacement value is determined by:

displacement of_{(accelerometer)}＝V_{(original position)}–V_{(New position)}

Wherein V is a sum of the positions of the accelerometer (24) in the x-direction, the y-direction, and the z-direction; and is

The second displacement value is determined by:

wherein D is_ScrollingIs raw data corresponding to the roll axis of the gyroscope (26).

14. The oxygen saturation monitor (10) according to claim 13, wherein the at least one electronic processor (22) is programmed to:

implementing a machine learning model to determine a corrected oxygen saturation measurement from the first displacement value and the second displacement value.

15. The oxygen saturation monitor (10) according to any one of claims 9-14, wherein the array of light sources (18) and the array of detectors (20) are arranged in a matrix;

wherein each light detector in the array of light detectors is configured to detect emitted light only from a corresponding light source.

16. The oxygen saturation monitor (10) according to any one of claims 9-14, wherein: the at least one electronic processor (22) is programmed to:

determining new pairs of light sources (18.1-18.9) and light detectors (20.1-20.9) to detect red and infrared light based on the movement detected by the at least one motion sensor (24, 26).

17. An oxygen saturation monitor (10), comprising:

a clamp (12) having opposing first (14) and second (16) clamp portions;

an array of light sources (18) disposed on the first clamp portion;

an array of light detectors (20) disposed on the second clamp portion, wherein each light detector in the array of light detectors is configured to detect emitted light only from a corresponding light source;

an accelerometer (24) configured to measure a displacement of at least one of the first and second clamp portions;

a gyroscope (26) configured to measure rotation of at least one of the first and second clamp portions;

at least one electronic processor (22) programmed to:

correcting the received red light data, infrared light data, and ambient light data detected by the light detector to eliminate the detected ambient light, thereby generating a corrected light signal;

summing the displacement data measured by the accelerometer and the displacement data measured by the gyroscope;

determining a light source in the array of light sources and a light detector in the array of light detectors that measure the red light data and the infrared light data using the summed displacement data and the corrected light signal;

detecting red and infrared light using the determined light source and the determined light detector; and is

An oxygen saturation signal is calculated from the detected red light and the detected infrared light.

18. The oxygen saturation monitor (10) according to claim 17, wherein both the array of light sources (18) and the array of photodetectors (20) are arranged in a 3x3 matrix;

wherein each light source (18.1-18.9) in the array of light sources is configured to emit red and infrared light; and is

Wherein a single light detector (20.1-20.9) in the array of light detectors (20) is configured to detect red and infrared light emitted from the corresponding light source, and the other light detectors are configured to detect red and infrared light emitted from the corresponding light source and ambient light.

19. The oxygen saturation monitor (10) of claim 18, wherein the at least one electronic processor (22) is further programmed to:

receiving red light data and infrared light data detected by the single light detector (18.1-18.9) and detected ambient light data from the other light detectors (20.1-20.9);

correcting the received data to eliminate the detected ambient light; and is

An oxygen saturation signal is calculated from the detected red light data and the detected infrared light data.

20. The oxygen saturation monitor (10) according to any one of claims 17-19, wherein the accelerometer (24) is disposed in the first clamp portion (14) and the gyroscope (26) is disposed in the second clamp portion (16).

Technical Field

The following generally relates to the field of patient monitoring, oxygen saturation monitoring, pulse oximetry, motion compensation, and related fields.

Background

Pulse oximeters are common devices used in clinical settings. Pulse oximetry for monitoring the blood oxygen saturation (SpO) of a patient₂) And (4) horizontal. Typically, in a clinical setting, a pulse oximeter may be attached to (i.e., hung from) a patient, and the pulse oximeter continuously measures SpO₂And (4) horizontal. Since the pulse oximeter needs to be continuously attached to the patient, the pulse oximeter is designed so that it does not attach too tightly to the patient's body part. The device is typically hung on one of the adult patient's index fingers (or any other finger). For pediatric use, the device is designed to be hung on the leg of a patient. The pulse oximeter should be loose enough so that it does not cause injury or discomfort to the patient due to the long duration of use. However, this design makes the device susceptible to movement as the patient's body moves.

The pulse oximeter is configured to be based on a pulse oximeter composed of hemoglobin (Hb) and oxyhemoglobin (HbO)₂) Measuring difference of absorption of red and infrared light, and determining SpO based also on arterial blood volume in the measured area of tissue₂And (4) horizontal. Any variation or interference of the measurement difference of the absorption or measurement volume affects the final SpO from the pulse oximeter₂And (6) reading. For example, the patient's movement may cause SpO₂A change in measurement position of the area. This change can lead to SpO₂The difference in readings because not every region of body tissue has the same volume of arterial blood. Dominating SpO₂Another factor in the accuracy of the measurement of (a) is the light source of the device, as this can affect the accuracy of the measured absorption difference in the red and Infrared (IR) wavelengths or ranges. However, pulse oximeters are typically applied externally (e.g., using clips attached to fingers, earlobes, baby's feet, etc.), and in these arrangements there is typically a gap between the photodetector sensor and the patient's skin. This gap can allow ambient light to fall onto the device's photodetector and contribute noise, which can be to the SpO₂The accuracy of the measurement is adversely affected.

New and improved systems and methods for overcoming these problems are disclosed below.

Disclosure of Invention

In one disclosed aspect, an oxygen saturation monitor comprises: a clamp having opposing first and second clamp portions. An array of light sources is disposed on the first clamp portion. Each light source is switchable between: (i) off, (ii) emit light of a first wavelength or spectral range, (iii) emit light of a second wavelength or spectral range different from the first wavelength or spectral range, and (iv) emit light at both the first wavelength or spectral range and the second wavelength or spectral range. An array of light detectors is disposed on the second clamp portion facing the array of light sources. Each light detector in the array of light detectors is aligned to detect emitted light from a corresponding light source in the array of light sources.

In another disclosed aspect, an oxygen saturation monitor includes a clamp having opposing first and second clamp portions. An array of light sources is disposed on the first clamp portion. An array of photodetectors is disposed on the second clamp portion. At least one motion sensor is disposed on at least one of the first and second clamp portions and configured to detect motion data of the at least one of the first and second clamp portions. At least one electronic processor is programmed to: receiving red light data, infrared light data and ambient light data detected by a light detector; receiving movement data from at least one motion sensor; correcting the received light data to eliminate the detected ambient light and to compensate for the motion data; and calculating an oxygen saturation signal from the corrected light data.

In another disclosed aspect, an oxygen saturation monitor includes a clamp having opposing first and second clamp portions. An array of light sources is disposed on the first clamp portion. An array of photodetectors is disposed on the second clamp portion. Each light detector in the array of light detectors is configured to detect emitted light only from the corresponding light source. An accelerometer is configured to measure a displacement of at least one of the first and second clamp portions. A gyroscope is configured to measure rotation of at least one of the first and second clamp portions. At least one electronic processor is programmed to: correcting the received red light data, infrared light data, and ambient light data detected by the light detector to eliminate the detected ambient light, thereby generating a corrected light signal; summing the displacement data measured by the accelerometer and the displacement data measured by the gyroscope; determining a light source in the array of light sources and a light detector in the array of light detectors using the summed displacement data and the corrected light signal to measure the red light data and the infrared light data; detecting red and infrared light using the determined light source and the determined light detector; and calculating an oxygen saturation signal from the detected red light and the detected infrared light.

One advantage resides in providing measurements of a patient's blood oxygen saturation level with improved accuracy.

Another advantage resides in reducing patient motion effects on blood oxygen saturation level measurements.

Another advantage resides in reducing the effect of ambient light on blood oxygen saturation level measurements.

Another advantage resides in compensating for motion-induced artifacts of blood oxygen saturation level measurements.

Another advantage resides in providing a pulse oximeter that is less sensitive to patient movement and variations in ambient lighting.

A given embodiment may provide none, one, two, more, or all of the above advantages, and/or may provide other advantages as will become apparent to those skilled in the art upon reading and understanding the present disclosure.

Drawings

The present disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the disclosure.

Fig. 1 diagrammatically illustrates an oxygen saturation monitor according to an aspect.

Fig. 2 and 3 diagrammatically show different embodiments of the oxygen saturation monitor of fig. 1.

Fig. 4 illustrates an exemplary flowchart operation of the oxygen saturation monitor of fig. 1.

Detailed Description

Conventional clamp-on pulse oximeters have a clamp design with red and infrared light sources in one clamp piece and a light detector in the opposite clamp piece. The device is clipped to a fingertip, earlobe, foot in the case of an infant, or other body part that is sufficiently thin to allow light from the light source to pass through the body tissue to be detected at the light detector. Peripheral SpO measurement based on the ratio of transmitted infrared light (e.g., 950nm) to red light (e.g., 650nm)₂And (4) horizontal. However, SpO₂The measurement may be adversely affected by stray light picked up by the light detector.

In some embodiments disclosed herein, to improve robustness to stray light, an array of IR/R light source/photodetector pairs is employed, where each IR/R light source (which itself is effectively a pair of light sources, one emitting red light and the other emitting IR light) is arranged to illuminate a single one of the photodetectors. The illustrative array is 3x3, but other sizes are contemplated. At SpO₂During measurement, only a single IR/R light source/photodetector pair is used to measure (uncorrected) SpO₂A signal. And is used to measure SpO₂The signal is used to detect any stray light to an adjacent detector. The following discloses a method for correcting the measured SpO based on the intensity measured by neighboring probes₂The formula for the correction factor k of the signal.

In other embodiments disclosed herein, a pulse oximeter may be provided with a displacement measurement unit that includes an accelerometer and a gyroscope mounted on the device. Both translational and rotational motion can be detected using this combination. The displacement measurement can be used in a number of ways, for example to trigger a measurement when the device is in motionPause, trigger a new calculation of the flare correction factor κ (since it can receive different exposures to flare as the device moves), or update SpO that is used to measure (uncorrected)₂Selection of IR/R light source/photodetector pairs for the signal.

In alternative embodiments, Machine Learning (ML) may be used to train the flare correction factor κ, the displacement correction, or both.

Referring to fig. 1, an illustrative embodiment of an oxygen saturation monitor 10 is shown. In some embodiments, oxygen saturation monitor 10 may be a pulse oximeter, wherein one or more vital signs are derived from measurements obtained from the oxygen saturation monitor. The oxygen saturation monitor 10 may be configured as a clamp 12, the clamp 12 having a first clamp portion 14 and an opposing second clamp portion 16 coupled together by a clamping mechanism 17 (such as a hinge having a biasing spring). In operation, when the clip 12 is attached to a body part, the clamping mechanism 17 biases the opposed faces 14F, 16F of the respective first and second clip members 14, 16 towards each other. The clamping mechanism 17 operates to bring the two opposing faces 14F, 16F sufficiently close to each other to ensure that the body part (e.g., finger F) is securely held by the opposing faces 14F, 16F. It will be appreciated that the face may optionally be contoured based on the intended geometry of the body part, and that the clamping mechanism 17 is designed to provide sufficient clamping force to hold the monitor 10 to the body part without discomfort to the patient due to excessive clamp pressure. As shown in fig. 1, the clip 12 is configured as a finger clip that is attachable to a patient's finger F (although the clip may be attached to any suitable portion of the patient, such as the ankle, wrist, etc., that is thin enough to transmit light from the light source 18 through the patient's body tissue (e.g., through the finger F) for detection by the light detector 20). In the illustrative example, the first clamp portion 14 is disposed on the "top" portion of the finger, while the second clamp portion 16 is disposed on the "bottom" portion of the finger.

It can be noted that the light source 18 and light detector 20 are typically embedded in the respective faces 14F, 16F of the respective clamp portions 14, 16 and can therefore be obscured from view when the monitor 10 is clamped to the finger F; this is indicated in fig. 1 by showing the light source 18 and the light detector 20 using dashed lines. It will also be noted that there may be some gaps or spaces between the light source 18 and/or light detector 20 and the finger F, as shown in fig. 1. It will be appreciated that these gaps or spaces may provide an entry path through which stray light may reach the detector 20. Furthermore, even if there is no such gap, the body part (e.g., finger F) to which the monitor 10 is clipped must be optically translucent in the red and infrared, so that light from the light source 18 reaches the light detector 20, and so stray light can pass through the translucent body part to reach the light detector 20.

With continuing reference to FIG. 1, and with reference now to FIG. 2, the light source 18 includes an array of light sources 18 disposed on the first clamp portion 14, and an array of light detectors 20 is disposed on the second clamp portion 16 facing the array of light sources, as seen in FIG. 1. Each light detector in the array of light detectors 20 is aligned to detect emitted light from a corresponding light source in the array of light sources 18. As shown in FIG. 2, the illustrative array of light sources 18 includes 9 light sources 18.1-18.9, and the illustrative array of light detectors 20 includes 9 corresponding light detectors 20.1-20.9. The light detectors 20.1-20.9 are arranged to detect only red and/or IR light from the corresponding light sources 18.1-18.9 (e.g. the light detector 20.1 only detects light emitted from the light source 18.1, the light detector 20.2 only detects light emitted from the light source 18.2, etc.). As shown in fig. 2, both the array of light sources 18 and the array of light detectors 20 are arranged in a 3x3 matrix, but any suitable configuration is possible. Further, the number of light sources in the array of light sources 18 (and likewise, the number of light detectors in the array of light detectors 20) may be any suitable number other than 9, as long as the number of light sources is the same as the number of light detectors).

Each of the light sources 18.1-18.9 in the array of light sources 18 is switchable between a plurality of operating modes, including: (i) off, (ii) emit light of a first wavelength or spectral range, (iii) emit light of a second wavelength or spectral range different from the first wavelength or spectral range; (iv) light of both the first and second wavelengths or spectral ranges is emitted. For example, in one embodiment, the first wavelength or spectral range is red light and the second wavelength of the spectral range is Infrared (IR) light. To this end, in one suitable arrangement, each light source 18.1-18.9 includes a red light source and an infrared light source. This is shown diagrammatically in FIG. 2, where the component light sources are labeled as IR light source 18IR and red light source 18R. (for ease of illustration, this labeling is done only for light source 18.3, but each of light sources 18.1-18.9 similarly includes two constituent light sources).

To control the operation of the light sources 18.1-18.9 between these multiple operating modes, the oxygen saturation monitoring also includes at least one electronic processor 22 (e.g., a microprocessor) programmed to control the array of light sources 18 to emit switched red and infrared light by a single active light source (e.g., light source 18.3) in the array of light sources, while all other light sources (e.g., light sources 18.1-18.2 and 18.4-18.9) in the array of light sources are off. This is suitably done by: activating the infrared light source 18IR to output infrared light; activating the red light source 18R to output red light; or not to activate the light sources 18IR or 18R when turned off. Electronic processor 22 is also programmed to control the operation of the array of photodetectors 20. For example, electronic processor 22 is programmed to control (or selectively read) the array of photodetectors 20 to detect switched red and infrared light using photodetectors 20.1-20.9 aligned to detect the emission light of a single active light source emitted from a corresponding central light source (e.g., central light source 18.5 is configured to emit light and corresponding photodetector 20.5 is controlled as the only photodetector that detects the emission light from the central light source). In addition, other photodetectors (e.g., photodetectors 20.1-20.4 and 20.6-20.9, or some subset of these other photodetectors) are controlled (or read) by electronic processor 22 to detect ambient light (e.g., light is not emitted from the corresponding light sources 18.1-18.4 and 18.6-18.9).

The oxygen saturation monitor 10 is configured to determine an oxygen saturation value (and optionally one or more vital signs, such as heart rate determined from pulsatile changes in red and/or infrared light) of the patient. In some embodiments, the electronic processor 22 is programmed to calculate a red light intensity/infrared light intensity ratio of the detected switched red and infrared light, correct the red light intensity/infrared light intensity ratio based on the detected ambient light, and convert the corrected red light intensity/infrared light intensity ratio to an oxygen saturation value.

Based on transmitted red R (e.g. λ)₁650nm) light and infrared IR (e.g.. lambda.)₂950nm) ratio of light, peripheral oxygen saturation (SpO) was measured₂) And (4) horizontal. For example, the ratio:

wherein, I_ac1、I_ac2The ac components of the intensity of red light (i.e., index ac1) and IR light (i.e., index ac2), respectively. Using for having full oxygen saturation level (e.g., SpO)₂100%) of healthy patients to convert the signal R to SpO₂Reading in percent (where, SpO)₂100% is total oxyhemoglobin). The pulse (i.e. heart rate) may also be detected as a periodicity of the intensity oscillations of the detected light.

However, SpO₂The measurement results (or equivalently, the values of the ratio R in the above example) can be adversely affected by stray light picked up by one or more of the light detectors (e.g., non-central light detectors 20.1-20.4 and 20.6-20.9). To improve robustness to stray light, the array of light sources 18 and the array of light detectors 20 are arranged in pairs. As shown in fig. 2 and as labeled for the exemplary light source 18.3, the light sources 18.1-18.9 are each arranged as a pair of switched light sources, one light source 18R emitting red light and the other light source 18IR emitting IR light. The light sources 18.1-18.9 illuminate the corresponding light detectors 20.1-20.9. At SpO₂During measurement, only a single IR/R light source/photodetector pair (e.g., light source 18.5 and light detector 20.5) is used to measure the signal ratio R. However, adjacent pairs of detectors (e.g., light detectors 20.1-20.4 and 20.6-20.9) operate to detect any stray light. The signal R measured by the selected pair may use a correction R based on the intensity values measured by the adjacent detectors (here indexed by j)_{Correction of}The correction is made R- κ, where the correction κ is given by equation (1):

κ＝∑_jα_jβ_jI_j (1)

wherein the content of the first and second substances,in the correction κ, the index j runs on a set of detectors adjacent to the pair for the measurement signal R (e.g. light source 18.5 and light detector 20.5), factor a_jIs a contribution factor of detector j (e.g. detectors closer to the edge of the array (e.g. detectors 20.3, 20.6, 20.9, receiving more stray light than detectors 20.1, 20.4, 20.7, as shown in fig. 2) are expected to detect higher stray light intensities and thus have higher values of a), factor β_jProportional to the euclidean distance of the detector j to the pair for the measurement signal R. Measuring intensity I without any light sources 18.1-18.9 operating for a given source detector 20.1-20.9 combination_st1And I_st2. Strength I_st1An AC component corresponding to the intensity of the red light component of stray light observed by detector j, and similarly intensity I_st2The ac component corresponding to the IR intensity component of stray light observed by detector j.

In other embodiments, the electronic processor 22 is programmed to correct the red light intensity/infrared light intensity ratio based on the detected ambient light using a Machine Learning (ML) model. The ML model is trained on historical oxygen saturation measurements. For example, it can be directed to have SpO₂Data is collected for 100% of healthy test subjects and standard data measurements are taken in complete darkness (e.g., placed in a dark room with no stray light present). Various intensity levels and spatial orientations of stray light may then be at the SpO₂The measurement period is applied together with the measurements of the other detectors, wherein all light sources of the set of light sources 18 are switched off. The ML model (which may be, for example, a Support Vector Machine (SVM), a neural network, etc.) is trained to receive these as inputs and output kappa values, which correct the measurements to output a priori known standard data SpO₂＝100％。

Referring now to fig. 3, and with continued reference to fig. 1, oxygen saturation monitor 10 optionally further includes at least one motion sensor configured to measure movement of at least one of first clamp portion 14 and second clamp portion 16. In these embodiments, the electronic processor 22 is programmed to determine the oxygen saturation value based on the detected red and infrared light along with the detected movement.

The at least one motion sensor comprises: (i) an accelerometer 24 configured to measure displacement of at least one of the first and second clamp portions 14, 16; (ii) a gyroscope 26 configured to measure rotation of at least one of the first and second clamp portions. As shown in fig. 3, an accelerometer 24 is provided on the first clamp portion 14 (and configured to measure its displacement) and a gyroscope 26 is provided on the second clamp portion 16 (and configured to measure its rotation), although the opposite arrangement may be implemented. It should be noted that since the first and second clamp portions 14, 16 are mechanically connected by the clamping mechanism 17, it is contemplated that the first and second clamp portions 14, 16 (along with the clamping mechanism 17) will be displaced or rotated as a single rigid unit.

The accelerometer 24 is configured to measure movement (e.g., lateral movement) data of the first clamp portion 14 in three dimensions (e.g., along x, y, and z axes). A first displacement value is determined by the electronic processor 22 from movement measurement data of the accelerometer 24. The first displacement value is determined by equation 2:

displacement of_{(accelerometer)}＝V_{(original position)}–V_{(New position)} (2)

Where V is the sum of the positions of the accelerometers 24 in the x, y and z directions.

The gyroscope 26 is configured to measure movement (e.g., rotational movement) data of the second clamp portion 16 in three axes (e.g., along a pitch axis, a roll axis, and a yaw axis). The second displacement value is determined by the electronic processor 22 from the movement data measured by the gyroscope 26. The second displacement value is determined by equation 3:

wherein the content of the first and second substances,is the rotational data along the roll axis of the gyroscope 26. It will be appreciated that only movement along the roll axis of the gyroscope 26 (e.g., rotation of the finger F in a clockwise/clockwise direction) is collected, as the finger does not rotate along the pitch or yaw axis of the gyroscope, which is transverse to the roll axis. In determining the oxygen saturation value, the electronic processor 22 is programmed to determine a final displacement value by summing the first displacement value (e.g., from data collected by the accelerometer 24 according to equation 2) and the second displacement value (e.g., from data collected by the gyroscope 26 according to equation 3).

In other embodiments, the electronic processor 22 is programmed to determine the displacement value using a Machine Learning (ML) model. The ML model is trained on historical oxygen saturation measurements, wherein displacement values are compensated. For example, it can be directed to have SpO₂Data was collected for 100% of healthy test subjects, with standard data measurements taken with the monitor completely motionless. Can then be at the SpO along with accelerometer and gyroscope measurements₂Various displacement and/or rotational movements are applied during the measurement. The ML model (which may be, for example, an SVM, a neural network, etc.) is trained to receive these as inputs and to output a motion correction that corrects the measurements to output a priori known standard data SpO₂＝100％。

It will also be appreciated that the motion sensors 24, 26 may be used in various ways in conjunction with ambient light correction. For example, to reduce the computational load, the ambient light correction factor κ may be calculated only intermittently. This is based on the expectation that the expected ambient light does not change except with movement of the oxygen saturation monitor 10. For example, the ambient light as seen by the monitor 10 may change at any time the monitor 10 is moved or rotated, as in this case the position and/or orientation of the monitor 10 relative to the bedside lamp or other ambient light source(s) may change. On the other hand, as long as the monitor 10 is stationary, the ambient light "seen" by the monitor 10 is unlikely to change rapidly. Even in the case of bedside lamps that are switched off, for example when lights are switched off, this is often accompanied by some movement of the patient. Thus, in some contemplated embodiments, the ambient light correction κ is re-measured and re-calculated relatively infrequently (e.g., at three minute intervals), but a detected movement of the monitor 10 will trigger an immediate re-measurement and re-calculation of κ.

Referring back to fig. 1, oxygen saturation monitor 10 also includes (or is controlled by) a computing device 28 (e.g., typically a workstation computer, or more generally a computer, although another form factor is also contemplated, such as a tablet, smartphone, or the like). Workstation 28 includes a computer or other electronic data processing device having typical components, such as at least one electronic processor 22 (which is alternatively embedded in fixture 12), at least one user input device (e.g., a mouse, keyboard, trackball, etc.) 30, and a display device 32. In some embodiments, the display device 32 may be a separate component from the computer 28.

One or more non-transitory storage media 34 are also provided to store data and instructions (e.g., software) that are readable and executable by computing device 28 to perform an oxygen saturation value measurement process as disclosed herein and/or that are executable by a workstation or another controller 18 to control oxygen saturation monitor 10 to measure oxygen saturation values (e.g., by determining and using final displacement values and corrected red light intensity/infrared light intensity ratios as described above). By way of non-limiting illustrative example, the non-transitory storage medium 34 may include one or more of the following: a disk, RAID, or other magnetic storage medium; a solid state drive, flash drive, electrically erasable read-only memory (EEROM), or other electronic memory; optical disks or other optical storage devices; various combinations thereof; and so on. The storage medium 34 may comprise a plurality of different media, optionally of different types, and may be distributed differently. The storage medium 34 may store instructions executable by the electronic processor 22 to perform the oxygen saturation value determination method or process 100. From the final displacement value and the corrected red light intensity/infrared light intensity ratio, the electronic processor 22 is programmed to determine an oxygen saturation value using an oxygen saturation value determination method.

Referring to fig. 4, an illustrative embodiment of an oxygen saturation method 100 is shown diagrammatically as a flow chart. At 102, when the clamp 12 is secured to the patient, the electronic processor 22 is programmed to control the central light source/detector pair (e.g., light source 18.5 and light detector 20.5) to measure red and IR light, while the remaining light source/detector pairs are controlled to measure ambient light.

At 104, the electronic processor 22 is programmed to correct the measured red and IR light data by subtracting the ambient light contribution from the measured light to generate a corrected oxygen saturation value. This correction may be performed by the electronic processor 22 using equation 1. In some examples, the corrected oxygen saturation value may be displayed on display device 32 of computing device 28.

At 106, the electronic processor 22 is programmed to control the accelerometer 24 and the gyroscope 26 to measure the respective lateral movement and rotational movement data. It will be appreciated that operation 106 may be performed before, after, or simultaneously with operation 102 (i.e., detection of light).

At 108, the electronic processor 22 is programmed to calculate a final displacement value from the motion data measured by the accelerometer 24 and gyroscope 26. Using the final displacement value, the electronic processor is programmed to calculate the displacement of the clamp 12 on the patient. For example, the home position of the clamp 12 (at operation 102) may be calibrated to have cartesian coordinates of (0,0, 0). The displacement coordinates may be calculated as (δ t1, δ t2, δ t 3).

At 110, the electronic processor 22 is programmed to map the displacement coordinates (δ t1, δ t2, δ t3) to the best possible light source/light detector pair corresponding to the same anatomical region (e.g., where the clamp 12 is attached) as originally measured. An "optimal" light source/light detector pair is the pair that detects the least amount of ambient light (and therefore the most amount of red and/or IR light) as determined using equation 1. To this end, the electronic processor 22 is programmed to determine new alpha and beta values for the detectors 20.1-20.9 according to equation 1 to measure ambient light according to the mapped displacement coordinates (δ t1, δ t2, δ t 3). For example, movement of the clamp 12 relative to the patient area to which the clamp is attached can result in the disabling of one of the light detectors 20.1-20.9The same weight (e.g., alpha and/or beta). In one example, a source/detector pair 18.5/20.5 is used to record SpO₂The value is obtained. The clockwise rotational movement of the finger F causes a similar movement of the gripper 12 as detected by the gyroscope 26. This detected movement may trigger the electronic processor 22 to determine that a new source/detector pair (e.g., 18.8/20.8) should be mapped to the finger F for measuring the pre-motion SpO₂Corresponding to the same anatomical region of value (e.g., the portion of the finger covered by the source/detector pair 18.5/20.5). This detected movement of the finger F causes a change in the layout of the array of light sources 18 and the array of light detectors 20, which requires the electronic processor 22 to calculate new alpha and beta values for all the detectors. For example, with the new calculation, detector 20.9 will have new α and β values similar to those detector 20.6 had before detecting rotational motion, since detector 20.9 is closer to the new source/detector pair 20.8, and on similar lines, all other detector weights can be calculated for each source/detector pair 18.1-18.9/20.1-20.9.

In another example, the source/detector pair 18.5/20.5 is again used to record SpO₂The value is obtained. Because of its proximity to detector 20.5, detector 20.6 has a high value of alpha and a low value of beta. If the patient adjusts the clamp 12 toward the wrist (e.g., by sliding the clamp along the finger F), this translational movement is detected by the accelerometer 24. The source/detector pair 18.4/20.4 begins to cover the same anatomical region of the finger F previously covered by the source/detector pair 18.5/20.5. The electronic processor 22 determines new alpha and beta values for all detectors 20 to determine that the source/detector pair 18.4/20.4 should be used to measure SpO₂The value is obtained.

At 112, the electronic processor 22 is programmed to use the new group of photosensors in the array 18 of light sources to label the new group as a new light source/detector pair 18.5/20.5 to detect the red and IR light signals to determine the oxygen saturation value of the patient.

The present disclosure has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the disclosure be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.