JP2022153480A - Health state monitoring systems and methods - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide systems, methods and devices for reducing noise in health state monitoring.

SOLUTION: The invention includes systems, methods and devices for monitoring which receive a health state signal for health state monitoring and/or have at least one electrode or sensor for health state monitoring.

SELECTED DRAWING: Figure 1A

COPYRIGHT: (C)2023,JPO&INPIT

Description

Advances in software, electronics, sensor technology and materials science have revolutionized patient monitoring technology. In particular, many devices and many systems are becoming available for widespread health monitoring applications. However, some improvements may still be desired for health monitoring devices and systems by which the devices and systems effectively collect data and/or detect and detect parameters. One or more of manipulations for parameter determination are provided.

And multiple options (alternatives, multiple alternatives, multiple new ideas, multiple alternatives, multiple mutually substitutable options) for patients and their physicians are robust. Robust, disturbance-tolerant, structurally stable and convenient monitors may be developed to include a number of monitors, which in some instances ( In instances), short-term data (short-term data, data useful over a short period of time, etc.) or long-term data (long-term data, data useful over a long period of time, etc.) is acquired (collected) and transmitted ( transfer and/or real-time monitoring of multiple events, and the multiple monitors may be multivariate in some cases. parameter (multi-variable parameter, multivariate parameter, one parameter with multiple variables, multiple parameters as multiple variables). do not have.

This document describes alternative medical monitoring devices, systems and/or methods and for parameter determination (identification, measurement, determination), the devices, systems and/or methods are, in some instances, one or more individuals. e.g. cardiac data and/or respiratory data and/or temperature, for such as neonates, infants, mothers/(or) parents, athletes or patients. It is intended for long-term sensing and/or recording of body temperature data. A number of alternative embodiments and applications are outlined in this document, below, and throughout this specification and/or exemplified.

In another aspect, several developments of those described in this document include an embodiment, in which a health device (device for monitoring health) describes one or more physiological parameters of one or more individuals (individuals, patients) , a plurality of time-concordant measurements taken by one or more sensors, wherein the one or more sensors are configured to monitor from an electrocardiogram one or more electrodes for measuring ion potential changes for electrocardiogram (ECG) and/or for optically based oxygen saturation measurement one or more light sources and one or more photodetectors (photosensors), in some cases including paired LEDs and photodiodes; and/or or one or more temperature sensors, such as thermometers, and/or movement and exercise, the use of physical loads or forces by the patient to cause said movement; one or more xyz accelerometers (instruments that measure acceleration in the directions of the x, y and z axes, triaxial accelerometers, accelerometers) for measuring mobility, exertion) , and the like, any of them, or variations consisting of one or more of them, non-exclusively. In some embodiments, some of the developmental methods and devices described in this document may be used to generate a respiration waveform. Some other embodiments include a circuit (in this document is sometimes referred to as a ``proxy driven right-leg circuit that realizes the same function as the original DRL circuit''), Conveniently, the common mode noise (common mode noise) generated in small-footprint devices that are worn or capable of being worn by an individual is , which may reduce interfering common-mode signals).

In an alternative aspect of what is described in this document, a blood pressure determination (blood pressure measurement) and, in some cases, pulse transit time (pulse transit time) may be generated from measurements of wave velocity, pulse transit time). The pulse wave transit time is the time for a cardiac pressure wave to propagate from the heart to other parts of the human body. Pulse wave transit time measurements may then be used to estimate blood pressure values. a signal representing heart beat timing from an electrocardiogram or otherwise and a signal representing photoplethysmogram (also known as PPG); It can be used to generate pulse transit time. It should be noted that such signals may be generated from conventional or other to-be-developed processes and/or devices or systems; may be obtained from one or more wearable health monitoring devices, such as those also described later in this document.

In yet another alternative aspect, the results of the developments described in this paper are, in some cases, pulse oximetry (non-invasive oximetry) signals (pulse oximetry). signals, signals representing arterial blood oxygen saturation, multiple pulse oximetry signals) and ECG signals (multiple ECG signals) that are time-concordant to several oxygen saturations There may be one or more methods and/or devices for measuring and/or determining oxygen saturation parameters. In some embodiments, the ECG signals are multiple intervals of pulse oximetry data, i.e., "multiple frames." can be used to define "frames", the time intervals or frames, of the pulse oximetry signal. , the strongest of the plurality of periodic components, the primary periodic component) (e.g., DC and AC components) are collected and averaged, e.g. , multiple frames are averaged per phase), and from those stationary and dominant periodic components, in turn, some numerical value for the oxygen saturation is determined (determined, detected, measured )Is possible. The device wearable to the patient, for some embodiments of this kind, includes pulse oximetry.
measurement, pulse oximeter) and ECG (ECG, electrocardiogram) sensors, the device may be particularly useful when placed on the patient's chest to acquire such signals. There is

some other alternative (mutually substitutable, capable of replacing another, optional) and/or additional (capable of being added to another) As with the aspects of , some of the aspects described above are illustrated in a number of alternative and/or additional embodiments and applications, which are illustrated in Some of which are shown in the accompanying drawings and characterized in the claims that follow. It will be appreciated by those skilled in the art, however, that the above Summary of the Invention and the following Detailed Description do not fully describe the full scope of the invention, nor, of course, the present invention. It is not intended to describe each illustrated embodiment of the invention, nor is it intended to describe every possible embodiment of the invention, nor is it intended to protect against any claims set forth later in this document. Nor is it intended to impose any limitation on the range.

The attached drawings include the following drawings.

FIG. 1 comprises and consists of FIGS. 1A-1R as subfigures, and this FIG. 1 represents alternatives of the development results described in this document. , alternatives), and this FIG. 1 shows a plurality of devices and a plurality of alternative conductive adhesives. It has various perspective, top, bottom and side views of the structure. 1B and 1C are diagrams showing the device. FIG. 1D is a diagram showing the device. 1E and 1F are diagrams showing the device. FIG. 1G is a diagram showing the device. FIG. 1H is a diagram showing the device. 1I and 1J are diagrams showing the device. FIG. 1K is a diagram showing the device. FIG. 1L is a diagram showing the device. FIG. 1M is a diagram showing the device. FIG. 1N is a diagram showing the device. FIG. 1O is a diagram showing the device. FIG. 1P is a diagram showing the device. FIG. 1Q is a diagram showing the device. FIG. 1R is a diagram showing the device.

FIG. 2 has and is composed of FIGS. 2A-2D as a plurality of partial diagrams, and this FIG. 2 shows several circuits of several alternatives of the DRL circuit. The diagrams are shown in FIGS. 2A-2C and in FIG. 2D a circuit diagram of a pulse oximetry. 2B and 2C are partial views of FIG. 2, respectively. FIG. 2D is a partial view of FIG. 2;

FIG. 3 is a flow chart with some alternative uses.

FIG. 4 illustrates an exemplary computer system or some computing resources with which some implementations of those disclosed in this document can be utilized. ing.

FIG. 5 has and is composed of FIGS. 5A-5D as a plurality of subfigures, which are alternatives in accordance with those disclosed in this document. Provides some alternative screen shots of some example software implementations. FIG. 5B is a screen shot of an example software implementation. FIG. 5C is a screen shot of an example software implementation. FIG. 5D is a screen shot of an example software implementation.

6A and 6B illustrate aspects of one embodiment of measuring oxygen saturation using pulse oximetry and electrocardiogram signals.

FIG. 6C is a flow chart showing several steps of one embodiment of detecting a value representing oxygen saturation.

Figures 6D and 6E show a specific example of detecting a numerical value representing respiratory depth.

Figures 7A, 7B and 7C show flow charts for several alternative methods in accordance with those disclosed in this document. FIG. 7C shows a flow chart for some alternative methods in accordance with those disclosed in this document.

The multiple inventions disclosed in this document are readily amenable to various modifications and alternative forms. may be employed), some of which the inventions may be embodied are shown, by way of non-limiting example, in this document, in the accompanying drawings and in the textual description that follows. It should be understood, however, that the intention is not to limit the inventions to the specific few examples described herein. The intent is fully understood to be contained in this document even if it goes beyond the literal meaning of the words used in this document or any drawings accompanying this document. The intent is to cover all variations, equivalents and alternatives, whether implied or otherwise, falling within the spirit and scope of the foregoing inventions.

In one aspect, the system described in this document can measure several physiological parameters, electrocardiogram (also known as ECG or EKG), photoplethysmogram, photoplethysmogram. (also known as PPG), pulse oximetry (arterial blood oxygen saturation), temperature (body temperature, etc.) and/or patient acceleration or motion signals. It is possible to include devices that monitor such things or all of them.

In addition, some systems described in this document can be configured to measure and/or process patient signals, such as those described above, wherein the systems include: using or having one or more of any kind, the plurality of elements having (a) a circuit, the circuit being a flexible or flex circuit board; may be flexible in (embedded or embedded) or on a surface of (board, board) or form such a circuit board, the circuit being flat Embedded in or on a surface of a resilient substrate or board, the substrate or board having a top surface and a bottom surface, the circuit comprising ( i) at least one sensor mounted in (embedded) or on the surface of the bottom surface of the flat elastic substrate or adjacent to the bottom surface of the flat elastic substrate, and Including one or more of those that are capable of electrical or optical communication with a patient. In some embodiments, the circuit is (ii) at least one signal processing module that receives and/or accepts signals from the at least one sensor, and in some embodiments further such and/or (iii) at least one memory for receiving and/or accepting and storing patient data; and/or (iv) at least one data communication module for transmitting stored or unstored patient data to an external device, and/or ( v) a control module of one or more of said at least one sensor, said at least one signal processing module, said at least one memory module and said at least one data transmission module; Timing (operation timing) and operation (operation) are controlled, and/or the control module commands transmission of patient data by the at least one data transmission module; command to erase and/or wipe data from said at least one memory module. In some embodiments, the system disclosed in this document may have (b) a conductive adhesive. , the conductive adhesive is removably adhered to the bottom surface of the flat elastic substrate, the conductive adhesive adhering to the skin of a patient or other user; It is possible, and in some non-limiting examples, that the systems disclosed in this document can only be oriented perpendicular to the bottom surface of the planar elastic substrate. and/or, in some embodiments, the system may be capable of causing electrical signals to flow in substantially coincident directions, and/or in some embodiments, the system may include a conductive portion adjacent to the one or more sensors. and a non-conductive portion. In some embodiments, the conductive adhesive has the property of conducting current in a direction that substantially coincides only with the direction perpendicular to the skin (i.e., "z-axis" conduction). It is an anisotropically conductive adhesive in that it has a plurality of regions made of a material having an anisotropic property.

In some embodiments, some of the devices described in this document are specifically intended for comprehensive and long-term cardiac monitoring. A number of features of this type of device include, but are not required to be, a lead 1 (1-lead, 1-lead) ECG, a plethysmography (PPG), a pulse oximeter, an accelerometer, Any kind of one or more of a temperature sensor (thermometer, etc.) and/or a button or other indicator for manually marking a patient event. It is possible to have Such a device may, for example, utilize up to about two weeks of continuous data (although in other embodiments it is feasible to utilize more or less data). can be designed to store data, which in some embodiments can be designed to store continuous data in clinics via a computer connection (computer-to-computer connection, etc.). or downloaded to another computer within a short period of time, in one example no more than about 90 seconds (although longer or shorter times may be feasible in other embodiments); The computer connection may be wireless or wired, and in one example the wired connection is via USB or other available data connection. A companion software data analysis package provides automatic event capture (automatically capturing patient events). and/or adapted to enable immediate or delayed, local data interpretation. be.

Intermittent cardiac anomalies are often difficult for physicians to detect and/or diagnose because such anomalies may be difficult for physicians to examine patients during physical examination. This is because it is necessary for detection and diagnosis to occur during examination, medical examination, etc. The devices described in this document are capable of addressing this problem, which in some embodiments is addressed by one or more vital signs, blood pressure, pulse, respiration, temperature, etc.) can be addressed by what is continuous or substantially continuous monitoring.

Some alternative features are, but are not exclusive: (i) a driven 'light' having multiple electrodes placed only on the patient's chest; A leg (driven "Right Leg (DRL)" circuit) and/or (ii) a "z-axis" or anisotropic conductive adhesive electrode interface (z-Axis or anisotropic conductive adhesive electrode interface, the conductive/adhesive interface between the electrode and the patient's skin that provides z-direction conductivity, i.e., anisotropic conductivity that allows electrical communication to occur only between an electrode and the patient's skin directly beneath the electrode and/or (iii) data transmission to and interpretation of data by a local computer accessible to CCU/(or) ICU personnel. and/or (iv) a unique combination of hardware that uses multiple data sources (multiple data from multiple sensors) to support diagnosis. It is possible to have one or more of which may be able to be associated with each other in time concordance with each other.

In some alternative, non-limiting embodiments, the devices and systems described in this document may: 1) be reusable ( in some cases approaching about 1000 or more patients), and it may be possible to recoup the cost of the device after only about 10-15 patient exams; and/or 2) ECG waveform data, inertial exertion sensing, manual event marking (manual marking of patient events), temperature sensing, thermometry, temperature sensing) and/or pulse oximetry, some or all of which are synchronized with each other for better detection and analysis of arrhythmic events. one or more, and/or 3) high efficiency watertight or waterproof (to allow the patient/(or) wearer to swim with the device on), and/or 4) it is possible to provide a comprehensive analysis package for near-instantaneous and on-site data interpretation; To provide a lightweight, thin walled, durable and flexible device to fit and move with the patient's skin during movement of the other device and/or the patient. Alternatively, it may be adapted to utilize flex-circuit (flex-circuit, shape-flexible circuit) technology.

Figures 1 and 2 show some examples of some alternative implementations of the devices designed as described above.

FIG. 1 is made up of and has all of the partial views FIGS. A top portion 101, a patient side or circuit side (bottom) 102, one or more inner electrical layers generally identified at 103, and a longitudinal strip. and a layer (an elongated strip layer, one elongated strip layer) 105 . The strip layer 105 can have electronics on its surface and/or in it. FIG. 1A illustrates a plurality of the elements described herein within what may herein be considered a device that, in some non-limiting embodiments, is a substantially transparent device. FIG. 4 is a perspective view showing the element along with some other elements that may be used with it; More specifically, FIG. 1B is directed to the plan view of the upper side 101, FIG. 1C is directed to the plan view of the lower side, the patient side (bottom) 102, and FIG. , is oriented in a side view, which is a first elevation view.

Most of the optional electronics described in the specification are one or more electronics layers 103. , here shown schematically, the plurality of electronic components are made of material 104 (see FIGS. 1A, 1B, 1D and 1K for some examples, and also, for example, 1N, 1O, 1P and 1Q, as detailed below), medical grade silicone, plastic or the like, i.e. It can be encapsulated using a potting material, encapsulant, etc., for the purpose of encapsulating the electronics, functionally disposed relative to the longitudinal strip layer 105 on or within it or in a determined position relative to the strip layer 105; to fix it in an operative position (a position in which actuation can be performed). The potting material or other material, in many embodiments, additionally or alternatively keeps the electronics in working condition in environments where water or perspiration is used. As in, it is possible to coat the plurality of electronic components in a waterproof, water-tight or water-resistant manner. One or more access points, doorways, passageways, windows, junctions or other functional units 106 may be placed on any side of and/or on the encapsulation material 104 described above. It may be provided through any side for the purpose of access to the outside and/or the electronics located inside or below the functional unit 106 . communication with the electronic component section). Figures 1A, 1B and 1D show four such accesses 106 on the top side (top side 101). The accesses 106 can include high Z data communication ports (data communication ports with high impedance or electrical resistance) and/or charging contacts, among others. This upper or component side 101 of the device 100 can be coated with a silicone compound for protection and/or waterproofing, where in some examples only the HS USB connector For example, via one or more ports (ports, doorways, communication passages, windows) 106, it is exposed for the purpose of communicating or transmitting data and/or for the purpose of charging.

Elongated strip layer 105 may be used to form a circuit or circuit portions, such as some electrical leads or some other inner layer conductors. components), such as leads 107 shown in FIG. 1D, or the circuit or circuit portions. and the purpose of said circuit or sub-circuits are electronics 103 and some electrically conductive pads or contacts 108, 109 and 110 to be detailed later (in some examples 108 and 109 are a plurality of silver electrodes with high impedance/high Z). ) or copper/silver electrodes, which acquire an electrocardiogram or ECG, and 110 is sometimes a reference electrode). In many embodiments, the strip layer 105 can be or have a flex circuit, which can withstand deformation, twisting, bending, and the like ( acceptable, tolerant, absorbable), but internally robust (tolerant to disturbances, structurally stable) multiple electrical circuit connections retain robust electrical circuitry connections, such that the plurality of electronic components residing within the flex circuit function as an electrical circuit; It is understood as something that maintains (strength, structural stability)). Note that although electronics 103 and electrodes 108, 109, 110 are shown attached to layer (strip layer) 105, they Elements may be formed or otherwise disposed within layer (strip layer) 105, or they may be , at least within a plurality of actuating positions having a defined relative position within one or more layers that are in fact co-existing with or adjacent to layer (strip layer) 105 may be arranged in such a way that they are indistinguishable from each other. Similarly, the plurality of leads or traces 107 are shown buried (indicated by dashed lines in FIG. 1D), but the leads or traces 107 are path) 107 may be on the top or bottom side, but more likely the top side to provide isolation from other electrical communications on the skin side. It is to exist above. The traces (conducting paths) 107 may have a first portion thereof located on the top (or bottom side) portion, but subsequent portions may be formed of an insulating encapsulant or the like. protective covers (not separately shown) and/or the insulating encapsulating material or protective covers, in many embodiments, layer (strip layer) 105 flexible material to maintain flexibility as an alternative property for all or most of the

On patient side 102, electrocardiogram electrodes 108, 109 and 110 can be placed exposed for substantially direct contact with the patient's skin (skin-electrode contact). and/or, in many embodiments, the patient-side electrodes 108, 109, and/or 110, as described below. Additionally, it can be coated with a conductive adhesive. The electrodes 108, 109 and/or 110 may be plated with a robust, highly conductive material, or , such material itself, for example silver/sliver chloride, suitable for biocompatibility and high signal quality. Yes, and in some embodiments, the electrodes 108, 109 and/or 110 are highly robust and in one non-limiting example, the electrodes 108, 109 and/or 110 can be used for approximately one thousand (1000) alcohol It can be designed to withstand washing. Windows or other communicating passages or openings 111, 112 (FIG. 1C) can be provided for the pulse oximeter, eg, for multiple LEDs and sensors. Such openings (through-holes, etc.) 111, 112 (e.g., FIG. 1C) are typically provided for optimal bi-directional light transmission to the patient's skin. It is possible to be One or more light conduits 111a/112a (and 111b/112b) installed in their place are shown in FIG. 111a/112a (and 111b/112b) are located in close proximity to and/or connected to electronics 103. there is A wide variety of alternative installations may be available in the specification, some of which will be detailed later.

In some embodiments, ambient light (with the plurality of LEDs turned off) is sampled and then the ambient light sample value is subtracted from each of the pulse oximeter signals; Thereby it is possible to eliminate noise caused by sunlight or other ambient light sources.

The LEDs and one or more photodiode sensors (sensor/LED set) described above may additionally and/or alternatively include a silicone layer thereby eliminating air gaps between the sensors/LEDs (the aforementioned sensor/LED set) and the patient's skin. Some examples of this kind are shown in FIGS. 1H and/or 1K and/or 1L and/or 1M and/or 1N, 1O, 1P and 1Q, respectively, which In the figure, silicone layers or coverings 121 and/or 121a and/or 121b and/or 121c and/or 121d are shown to be the light conduits (111a/112a) and/or or shown covering/(or) surrounding the sensor/LED 111c/111d/112c. LED 111c (one or more of FIGS. 1H and/or 1K and/or 1L, 1M, 1N, 1O, 1P and/or 1Q) may be a red LED. , and LED 111d (FIGS. 1H and/or 1K and/or one or more of FIGS. 1L-1Q) may be an IR (infrared) LED, and the device (the device, said sensor) 112c (one or more of FIGS. 1H and 1K and/or FIGS. 1L-1Q) may be a sensor. a plurality of LEDs that are alternative, mutually substitutable, capable of substituting for others, and/or additional (that can be added to others); may have, in a first example, one or more additional or alternative colors, in addition to or in place of the LED light colors previously described. 1H and/or 1K and/or one or more of FIGS. 1L-1Q. Alternatively, the LED may be, for example, a green LED (not shown), which may perform additional and/or alternative functions, as will be described in greater detail below.

Some other alternative arrays, sets, combinations, etc., or arrangements comprising LEDs and sensors are shown in FIGS. 1L and 1M. In those figures, one or more LEDs are mounted on a substrate 105a in an epoxy/light-pipe (epoxy or light-pipe, single pipe) 121c. Inside, it is rather centrally located and one or more sensors or photodiodes are relatively peripherally located. In FIG. 1L, two LEDs 111c and 111d (similar to LEDs 111c and 111d shown in FIGS. 1H and/or 1K, but the similarity is in positioning/geometry). ) is shown relatively centrally located with respect to one or more sensors, which in this example are two sensors or photodiodes 112c and 112d. . As described above with reference to FIGS. 1H and/or 1K, LED 111c may be a red LED, LED 111d may be an IR (infrared) LED, and devices 112c and/or 112d may There may be one or more sensors, in this example two sensors or photodiodes 112c and 112d. In FIG. 1M there are four LEDs 111c, 111d, 111e and 111f (similar to LEDs 111c and 111d shown in FIGS. 1H and/or 1K, but the similarity may vary in number, positioning and/or geometry geometry) is shown relatively centrally located with respect to one or more sensors, which in this example are four sensors. or photodiodes 112c, 112d, 112e and 112f. LED 111c may be a red LED and LED 111d may be an IR (infrared) LED, and/or as described above with reference to FIGS. 1H and/or 1K and/or 1L; LED 111e may be a red LED, LED 111f may be an IR (infrared light) LED, and devices 112c, 112d, 112e and/or 112f may be one or more sensors; , the sensors are four sensors or photodiodes 112c, 112d, 112e and 112f.

Arranging the LEDs (the LED or LEDs) according to the more centrally located arrangement shown in FIGS. 1L and 1M results in a relatively conventional which surrounds a centrally located sensor or photodiode with an LED, a very large portion of the emitted light emanating from the LEDs (LED or LEDs) A geometry is provided that may be disposed to capture (much greater percentage, greater than 50%, etc.). When employing such relatively or relatively conventional geometries, substantially all of the emitted light that travels away from the photodiode is wasted. become (wasted, not put to good use). When employing the geometries shown in FIGS. 1L and 1M respectively and/or the geometries described with reference to FIGS. Light may be captured by the sensor or photodiode, or in some cases with much higher efficiency than before. is done. Thanks to this highly efficient light capture, the number of LEDs required is not central to itself, unlike the conventional Multi-LED integrated sensor, the light source-sensor unit according to the present embodiment. A sensor in which a plurality of LEDs are incorporated in a part). This contributes to a significant reduction in power consumption, but may nevertheless achieve the same or higher quality measurement results. In short, multiple LED geometries, such as the red and infrared combination described above, are combined with an array of photodiodes (or sensors). The geometry directs light to subcutaneous regions of a subject (e.g., patient, infant, newborn, mother, athlete, etc.). It may be possible to have a high degree of concentration within. The above-described LED and photodiode/sensor combination, in some embodiments, is a High-Efficiency Integrated Sensor (Sensor), such that the reflected light is captured by the sensor with high efficiency. It may also be referred to as a sensor with an integrated LED in the center. This arrangement may be implemented to measure SpO2 (peripheral capillary oxygen saturation). It should be noted that in some practical implementations, some of the aforementioned ^sensors , for example shown in FIGS. The diameter of the outer circle surrounding the LED may correspond to approximately 8 mm. In some embodiments, about 3.2 mm may be set as the desired distance from the center point of the red light LED light source to the corresponding center point of a sensor or sensors. Also, approximately 3.7 mm may be set as the desired distance from the center point of the infrared LED light source to the corresponding center point of a sensor or sensors.

This silicone layer or covering 121/121a/121b/121c/121d/121e reduces the amount of light lost to reflected light from the patient's skin, thereby increasing the signal, the sensor As the signal of the sensor (112, 121c, 112d, 112e, 112f) is greatly increased, noise caused by movement of the patient's skin relative to the sensor may be greatly reduced. unknown. In some embodiments, the silicone layer may be referred to as a light pipe, and in some situations the silicone layer is transparent, colorless, and/or may be medical grade silicone. As will be detailed later, said silicone layers or covers 121 and/or 121a and/or 121b and/or 121c and/or 121d and/or lens surface 121e (referred to in this document as 121/121a/121b/121c/121d/ 121e, but their respective meanings do not change) are additionally and/or alternatively referred to in this document as light pipes or lenses 121/121a/121b/121c/121d/121e. may be called, but the name means that the element transmits upon emission (light emitted from elsewhere, direct light) or upon reflection (reflects elsewhere). light transmitted through it) and/or transmit that light; do.

In one or more embodiments, thereof an encapsulant, encapsulant, sealing body, potting material, filling within the cavity to contain an object within the cavity. and/or the lenses 121/121a/121b/121c/121d/121e may be manufactured from medical grade silicone, which is transparent, colorless, soft, and low durometer. and one or more of Some good examples of specialized silicones that may be used with those described herein are "tacky gels" (supplied by several vendors), and a good example of this typically consists of multiple sheets of high-tack adhesives. The adhesives are preferably embedded on both sides (on both sides of the tacky gel, on both sides of the silicone). , is a double-sided adhesive type). Combining a low durometer silicone with double-sided adhesives, which are adhesives present on both sides of the tacky gel, lenses 121/121a/121b/121c/121d/121e are obtained as described above. electronic sensors and skin conform to and, in some embodiments, further the movement (relative displacement) between the skin, the lens, and the sensor interfaces (interfaces where different parts contact each other). Limiting exhibits the property of reducing motion artifacts (artificial noise caused by movement, body motion artifacts, noise or artifacts caused by movement of the patient during exercise). It is possible to The lens according to the description may additionally and/or alternatively be provided with a composite adhesive strip, a heterogeneous, composite adhesive strip consisting of two or more different parts. , composite cohesives 113, 113a) (see, e.g., the options shown in FIGS. 1D, 1G, 1I and 1J). can have a raised shape, wherein in some embodiments the lens additionally has a raised portion (convex portion), the raised portion having the same size as the size of the openings (openings, through-holes, etc.) in the composite adhesive strip (composite adhesive strip 113, 113a), and sometimes the openings are rectangular, The ridge allows the lens to protrude slightly from the patient side of the composite adhesive stripe (more detailed description with respect to FIG. 1K is provided below).

In FIG. 1K, yet another silicone cover or encapsulant for the LEDs and sensor 111c/111d/112c. etc.), one embodiment for 121a may have a convex lens at or adjacent to cover outer surface 121b. In many embodiments, the external surface (cover outer surface 121b) and the lens (the lens) are the same piece and/or the lens (the lens) is the encapsulating material 121a. It may be formed by the surface (cover outer surface) 121b. What is provided by what is described herein is that the device is mounted on the patient's or user's body at the chest or forehead (e.g., in the case of infants or neonates). interface between the pulse oximetry LED emitters 111c/111d and one or more photodiode sensors 112c and the skin surface, whether at the site or at another site. It is a structure and method for intermediating, interoperably linking with.

Specifically, as otherwise described herein, the system and/or device 100 thereof may include one or more LED emitters 111c/111d (and/or 111e). and/or 111f) with selected wavelengths and one or more photodiode sensors (sensors, receivers, 112c). However, the LED/sensor set (combination, 111c/111d/112c, LED and sensor combined) is firmly coupled to the skin 1001 of the wearer 1000 so as not to move. the encapsulant and/or lens 121/121a/121b/121c/121d/121e to maximize the possibility that optical which is substantially transparent and composed of medical grade silicone is molded onto the LED/sensor set 111c/111d/112c. Alternatively, the lens 121b covers the LED/sensor set 111c/111d/112c after molding (later, after molding in advance and after molding) ( may be worn so that a covering relationship exists. In many embodiments, as illustrated in FIG. 1K, the lens 121b may be partially spherical, or perhaps essentially hemispherical, although this is not essential and will be discussed later. See, for example, FIGS. 1N-1Q. Likewise, different shapes of curvature may be useful. Due to the curvature, the likelihood of losing contact with the skin may be reduced when the device 100 is moved, whether by motion of the wearer or not. That is, movement of the wearer 1000 in FIG. 1K or movement of the device 100 relative to the wearer 1000 may result in the lens (121b) being in contact with the skin 1001 or in relation to the skin 1001. , quasi-rolling contact. Maintaining good contact with the skin means that good data acquisition is uninterrupted and/or low noise. Some embodiments described above and some embodiments described below (not shown directly, i.e., may or may not be substitutable for those shown). or, in some embodiments, a thin silicone adhesive, as described below with particular reference to FIG. 1Q. 113e is applied over or between the silicone layers 121/121a/121b/121c/121d/121e, whereby the silicone encapsulant 121/121a/121b/121c/ Helps maintain skin contact to 121d/121e. See, for example, the description of FIG. 1Q below.

Also related to the ability to maintain contact is the light piping effect. The pipe effect prevents transmission from being interrupted by air gaps (air gaps in the material of the light pipe 121a), even though the LEDs and sensors may have different heights. said light pipe of (of) an encapsulant 121a/121c/121d/121e with substantially little or substantially no transmission interference, signal disruption, said output; This may be achieved when the emission, the light source such as the LED, the light emitting part, etc., passes from the skin to the skin and vice versa from the skin to the sensor. the path from the emitter (e.g., emitter, emitter, etc.) to the light pipe 121a/121c/121d/121e, which may have a curved surface (cover outer surface of lens 121b) 121b; and light pipes 121a/121c/121d/121e, which may have a curved surface 121b, and the light pipes is in contact with the skin in a substantially stable manner, when it is transmitted into the skin (incident), it is reflected in the opposite direction to the incident light as return light from the inside of the skin. and when re-transmitting through the material of the light pipes 121a/121c/121d/121e back to the sensor (112c) (both transmission and reflection mean light travel), the air cap no, substantially no, or substantially no interruptions due to gaps (air gaps between skin and device). This reduces inefficiencies caused by scattering of light waves at air gap interfaces (interfaces between skin and device where air gaps exist). (Air gaps allow light to bounce off the skin or other surfaces (reflect unintendedly, reflect without entering the skin)). That is, the encapsulation of the plurality of LEDs and the plurality of sensors provides the absence of air gaps and light pipes, and the curved surface (cover outer surface of lens 121b) provides It allows transmission into the skin and reception of reflected light from the skin and bones with high quality and low scattering. The light pipe and curved surface allow for uninterrupted contact with the skin, and the lens (121b) reduces the amount of signal loss due to skin reflections. Its signal-to-noise ratio is reduced and data acquisition is improved in terms of its quality (accuracy).

Accordingly, encapsulants 121/121a/121c/121d and/or lenses 121b/121e of this type may serve one or more purposes, which in some examples may include, among others: 1) The "light-pipe" effect is defined by the fact that multiple LEDs and multiple sensors with different heights are tightly coupled to each other to ensure a consistent quality or otherwise between all LEDs and sensors. ensuring high quality without the need and substantially stable and firm coupling to the skin, in such a way that motion artifacts are reduced 2) focusing emitted light that passes through the skin and reaches the bone; and 3) reflected light that passes through the skin and reaches the bone. and focusing what reaches the photodiode sensors (receivers, 112c).

It is also worth noting that for the curved lens 121b as an option, as can be seen from FIG. It means that it may be designed to maximize up to The height of the lens (121b) is so large that it protrudes from the composite adhesive 113 of the device 100 and digs into the skin, causing obstruction of the capillary bed, which is another cause of data failure. It may be designed so that it is possible not to dig deep into the Furthermore, there is not necessarily a need for a high degree of control over the radii of curvature (the radii of curvature of lens 121b) and the angles of LED lightwave emission. and the plurality of LEDs used to pass through the skin, for example red LEDs and infrared LEDs and/or green LEDs, achieve a plurality of different emission angles over a very wide range, Thus, a large number of widely different reflected lights will be focused back to the sensor by a plurality of widely different curved surfaces (cover outer surface of lens 121b). For that reason, said need does not exist. That is, the curved surface is useful for maintaining contact during periods of motion (whether accidental or intentional), and the curved surface has an angle of penetration through the skin. and less important for the angle at which it reflects back to the sensor. In other words, many different radii of curvature (the many different radii of curvature that lens 121b has) result in very small differences in data/(or) wave transmittance and reflectance. For this reason, the wide emission angle of the LEDs takes care of what might be a variety of radii, If an LED with a wide output angle is used, it is not necessary to finely determine the range when there are multiple radii of curvature of the lens 121b). Rather, the curvature (the curvature of lens 121b) may have more limitations in maintaining contact due to device 100 movement, e.g., a more flattened curvature. curvatures) do not roll easily, and very small radii of curvature do not send or receive much data.

In some embodiments, a radius of curvature of about 20 mm to about 40 mm is found useful for a device having multiple LEDs and multiple sensors within a section of dimensions about 12.6 mm by about 6.6 mm. (both a radius of curvature of 20.34 mm and a radius of curvature of 39.94 mm were found to be useful). It may also be noted that multiple LEDs may be present on one or the other side or both sides, or perhaps 4 LEDs substantially equally spaced around the circumference of one sensor. that each may be placed in more than one position and the LEDs may provide the desired result.

It is further noted that the pulse oximetry described herein may have multiple light sources and/or multiple sensors, which may be shown in FIGS. 1H and 1K and/or, for example, FIGS. It may be one interpretation for some of the arrangements shown in any one or more of Figures 1Q. A typical pulse oximetry electrical circuit is for each wavelength (typically red light, infrared light, and possibly other lights including green light, or , long time averages of red light/(or) infrared light, long time averages of the intensity of each signal, the long time of the multiple intensities that each signal has over time The average of what is present in the interval, the long-term average of the data represented by the waveform, the time-average, whichever is longer than the other time-average, and the red light used to measure oxygen saturation and time averaging with a longer time interval than for infrared light)) using one light source (LED). However, the devices and/or methods described herein may utilize multiple light sources for each wavelength. This allows for the interrogation of extensive capillary beds within/on the patient/wearer with the aim of mitigating the effects of local motion artifacts. may be allowed for. Similarly, multiple sensors may each be used to achieve the same or similar purposes or advantages.

In addition, a DRL circuit (right leg drive circuit, right leg drive circuit, right leg driven circuit, right leg driven circuit) and/or proxy driven right-leg circuit (proxy driven circuit). Another effect can be obtained by combining pulse oximetry with a DRL circuit (sometimes referred to as a pseudo right leg drive circuit). The DRL circuit, the surrogate DRL circuit and/or the right foot drive circuit, whether for chest, forehead or other electrode placement locations, are free from common mode noise ( Common mode noise, common mode noise, common mode signal mixed as noise) and power line noise, if present without being removed, will be capacitively coupled inside the pulse oximetry sensor. -coupled) that would/could reduce the effectiveness of the sensor. DRL circuits (driven right leg, right leg driven circuit, right leg driven circuit, right leg driven circuit) and/or proxy driven right leg (proxy DRL circuit, pseudo right leg circuit) and a lens as described in and for this FIG. 1K and/or any of FIGS. 1H and/or 1L-1Q. Combined with improved pulse oximetry using several light pipes shown in one or more of It is possible to For drive electrodes, see further details below.

Thus, measurements of arterial blood oxygen content can be made using several optical signals (sometimes also referred to as heartbeat optical signals), which optical signals is typically obtained from a red light pulse signal source and an infrared light pulse signal source, and the red light pulse signal source and the infrared light pulse signal source are optically different from each other depending on the presence or absence of oxyhemoglobin, respectively. Indicates absorption rate. Briefly, a transmissive system (transmissive optics) is used together with a light source and an optical detector. As will be discussed below, many embodiments may employ a light pipe encapsulating either or both of said light source or sources and said sensor or sensors. In particular, the light pipe that encloses the light pipe in the sense that there is substantially no air gap is considered to be the irradiation efficiency when the light is irradiated to the skin. ratio of the output light, etc.) and/or the efficiency in capturing multiple photons that would otherwise be lost when the light pipe is used to collect the output light. may be used for

A number of reflective systems (reflecting optics) are typical here, and they often have some advantages, which are the invasiveness. Low intrusiveness (property of intrusion of signals from the outside, property of intrusion of signals from the outside, mutual invasiveness, invasiveness, etc.) and possibly high portability. As described in this document, some such reflective systems typically employ red and infrared light sources and photodiode-type sensors or detectors, or A plurality of arrangements for these components are employed. As also described in this document, one embodiment/method includes one or more photodiodes/sensors/detectors that are centrally located and have a wide detection surface. , often one or more LED light sources, each a red-light LED light source and an infrared-light LED light source, adjacent to the photo-diode, photosensor, etc. Alternatively, it may be employed in a line surrounding the photo-diode (photosensor, etc.). Another arrangement, also described in this document, is a central LED set consisting of one or more light sources and located centrally, for each wavelength type (red light, infrared one or more of each wavelength type (light, green light, etc.) and a plurality of photodiodes or light sensors, wherein with a wide detection surface and surrounding the central set of LEDs. An arrangement of this kind uses 2, 3 or 4 detectors of this kind surrounding the LED, so that it scatters from the LED. radiating out) to collect and detect a greater amount of light passing through skin and other tissues, see, for example, FIG. 1L and/or FIG. 1M.

Yet another embodiment enhances said light source and/or said one or more photodiodes and/or includes structural enhancements located around them. may be adopted. Firstly, one or more of the aforementioned stiffening structures arranged in connection with the aforementioned central LED arrangement will be described, but the latter will be referred to as the aforementioned central sensor arrangement. ) can also be used with or in conjunction with The optical enhancing structures may minimize intrusion into the collection area, light collection area, light detection area, and These stiffening structures may reduce the area of the photodiode area (the area where the photo-diode (such as a light sensor) is located, the sensor area) or reduce the number of photodiodes. Cost advantages and/or efficiency gains may result.

1N, 1O, 1P and 1Q, within light pipe 121d, on substrate 105a, a plurality of central LED light sources 111c and 111d are surrounded by a barrier 122 (in is isolated from a plurality of photodiodes (photo-diodes, photosensors, etc.) 121c, 121d, 121e, and 121f located peripherally from the light source by optically blocked). Also shown is an optional additional outer barrier 123 surrounding the sensor area (where the plurality of photosensors are located). Barrier 122 (ie, B1) and/or outer barrier 123 (ie, B2) are desirably opaque and/or emit both red and infrared (or any other of the lights in use). (e.g. green), thereby preventing cross-talk between the LED and the sensor, i. directly, without reaching the skin first, into the light path incident on the sensor, but rather that all of the emitted light from the LED is incident on the skin. Want. Desirable surfaces for the barriers (122, 123) are diffuse-reflective (generally relatively absorptive and/or specularly reflective ( (unlike relative, where absorptive and specular reflectance are stronger than diffuse reflectance). One example may be transparent aluminum oxide. Another example would be white paint with surface irregularities. Operation is illustrated and described in connection with FIGS. 1P and/or 1Q, see discussion below.

The shape and size of barrier 122 can be appropriately selected to match the shape and size of the LED light sources, here multiple light sources 111c and 111d. For example, barrier 122 may be circular as shown, but may be square or rectangular in shape or other shape (not shown) surrounding multiple LEDs 111c, 111d. No (note further here that more or fewer light sources may be located within or surrounded by barrier 122). Similarly, the width or thickness dimension of barrier 122 and the materials used for barrier 122 may also be variable or varied depending on requirements or goals. may have), and indeed the relative (such as in comparison with other optical properties) opacity of any particular material may be the particular level of opacity, (such as the opacity of the barrier as a component) or relative (such as in comparison with other optical properties) diffuse-reflectivity (such as the diffuse reflectance of the barrier as a component). It may mean that it is thinner or thicker than the required width dimension (even if a material does not have opacity, a greater thickness of the material may achieve opacity for the material, Conversely, the width dimension may depend on the material, in that if the thickness of the material is small, the material is not opaque, but rather translucent, or vice versa. may be. individual specific wavelengths of light, i.e. the type of light used and/or the type of sensor or each type of sensors and/or relative and/or as a whole Some geometric relationships (sensor-to-source, sensor-to-sensor, and/or source-to-source) of the the relative dimensions, the width dimension, etc. used for and/or materials, and/or the relative opacity in relation to the specific number of wavelengths Due to the relative dimensions, the width dimension, etc. used and/or may be figured into when selecting materials. To some extent the relative thickness dimension may be more strongly related to the type of material comprising the barrier, its opacity or relative diffuse reflectance. Some situation may exist. In some embodiments, the barrier may be a machined material, an oxidized material, or other similar material, while in some other embodiments, the barrier may be , a synthetic resin, for example a molded synthetic resin. For applications where red and infrared light are used, a driving consideration for operating conditions is whether the material is opaque at both 660 nm and 940 nm, possibly and desirably. Or it may be that it is reflective or it is diffusely reflective. Thus, in some cases, very thin aluminum meets this requirement, as does thicker synthetic resin.

Some options for barrier 122 are primarily sideways propagation of the emitted light from said LEDs (e.g. red or infrared light from e.g. LEDs 111c/111d for the previous case). propagation, etc.), and the barrier 122 desirably has the same height as or slightly less than the light exit window of the LED. has a high height. Desirably, barrier 122 also has a width dimension sufficient to prevent optical crosstalk of rays that never impinge on the skin or scattering materials, but the width dimension is It is not so thick that light from the LED scattered from skin or other flesh material is prevented from reaching the photodiode detector located outside the barrier. There is no.

An optional external (external or perimeter of the light source-sensor unit located outside the light source area) barrier 123 may also be employed. This assists in collecting reflected light from the patient or user. Regarding the outer barrier 123, similar size and thickness dimensions and materials may be considered, the difference being primarily that of light collection. That is, it is not the point of light emission.

Due to these developments, such as the improved techniques described above, some outer If an improvement with external detectors (external sensor arrangement) is provided, an optical collection structure is added, which consists of several detector diodes (light detectors). It is possible to collect light from other areas than the area in which the sensor is present and that radiation in such a way that it reaches one or more of said several detectors. , light that would not have been captured if it had not been reflected from the barrier). Note that with some detectors (some photosensors) located centrally (located inside the light source area, inside or centrally of the light source-sensor unit) There are also improvements similar to those described above that are used in combination with a plurality of light sources that are isolated from each other individually (not shown) in a manner different from that of the outer detector. may have issues.

Some structures desirable when employing this type (such as the light source/sensor embedded light pipe disclosed in this document) include a transparent optical medium, here the light pipe material 121d previously described. may have. The light pipe material is positioned inside and/or surrounded by a relatively opaque barrier 122 (such as by comparison with the opacity of other optical elements). (see, for example, FIG. 1Q), and this light pipe material may be molded into light sources 111c and 111d (and/or other light sources, if present). ) within the barrier 122 and/or outside the barrier 122 (between the barriers 122 and 123) diode detectors (photosensors) 112c, 112d, 112e and/or 112f (and/or other photosensors, if present), the light sources and photosensors are embedded in that structure (the light pipe material) 121d. and the light pipe material with little or substantially no air gap. A detector device (detector device, sensor device, etc.) 121c, 121d, 121e and/or 121f is molded into the optical medium, i.e. the light pipe material itself. Alternatively, it may be located in some cavity premolded in the optical medium. Some optical structures employing this type may collectively be referred to as a "light pipe".

The shape of light pipe structure 121d and/or surface 121e can be selected in various ways, depending on the number and size or shape of the several detector diodes mentioned above, and light pipe structure 121d. and/or the shape of surface 121e may be adjusted in some way, i.e., scattered light received from skin or other flesh material that is not in direct contact with or located above any detector diodes. (scattered light) and contain it by total internal reflection (total internal reflection, inward total reflection, total reflection between multiple barriers), and By using a diffusely reflective surface, the light rays can be deflected toward one or more of the photodiodes (photosensors). It may be designed in such a way that According to such methods, light that would be lost in conventional design structures is captured by some devices according to some embodiments described above. In FIGS. 1N and 1O, the epoxy body (light pipe) 121d is relatively (eg, by comparison with other optical elements) flat, i.e., with a relatively flat surface 121e. Epoxy body (light pipe) 121d may be curved to cooperate with the barrier or barriers disclosed in this document, although having a surface that is neither concave nor convex. FIG. 1Q shows a relatively or substantially flat surface 121e.

Also shown in FIG. 1Q is an optional thin layer silicone adhesive 113e residing on surface 121e. The thin-layer silicone adhesive 113e reduces the movement (movement, relative motion, etc.) of the device with respect to the skin to reduce light transmission (light transmission, light emission, etc.) and light reception. It may also be used to fixate the device relative to the skin (not shown here) so that its properties (light reception) are improved. When this type of cohesive is used, the cohesive preferably has the practicality of neither interfering with nor causing refraction of some light waves passing through it ( operably possible, practical). A thickness of 0.2 mm may be so operable as that may be met. Furthermore, this (it, the relationship between the refractive index of the adhesive and the refractive index of the light pipe) indicates that the refractive index of the adhesive is epoxy/encapsulation/light pipe 121/121a/121b/121c/121d/121e. that it may be desirable to be similar to that of Selecting refractive indices that are similar to each other in this way may be useful or may be done depending on the material and thickness of the cohesive to be used. For example, a suitable similarity in terms of refractive index may arise from or reach a practical thickness of 0.2 mm.

Figures 1P and 1Q show some operative examples and/or some alternatives. Light pipes are not shown in FIG. 1P for simplicity of illustration, but this may be considered a practical variant, and this figure shows several light waves exiting. (wave emissions, light wave emissions, emitted light waves, etc.) A, B and C are shown emanating from an exemplary LED 111c. Lightwave A is relatively direct outgoing light and does not hit any obstacles on its path from the device to the skin (not shown). , whereas lightwave B is shown as reflecting away from barrier 122 (note that some lightwaves are sometimes described as discrete (partial) However, it is understood that, for example, light energy is or is better understood as a plurality of photons, more specifically understood as emitted light and/or recovered light. That light energy, in whatever form it may or may not be, is assumed in this document.The less desirable is light wave C, which light wave C is , not shown as reflecting away from the barrier 122, this light wave C is here exclusively the light wave emitted from the LED, for the most part, if not all, of the LED It is shown to emphasize that it is desirable to travel along a path to exit from the LED area and enter the user's skin (not shown here). Received light is illustrated in relation to exemplary sensors 112c and 112d, where FIG. , as a straight line of light, as light traveling in a straight line without colliding with other objects) is shown as light wave D which enters said sensor area and is captured by sensors 112c and/or 112d. Also shown is a Reflected (reflected from the skin) light wave E, which may be reflected away from barriers 122 and/or 123. Note that the substrate The bottom surface (floor, floor surface, base surface, etc.) of 105a, that is, the top surface also has diffuse reflectivity for the plurality of light waves, and the light waves are finally collected by sensor collection (sensor 112c and 112d).

One or more light pipes 121d are shown in FIG. 1Q, and an optional thin layer adhesive 113e is also shown. The relative refractive indices of these materials (such as in relation to the refractive indices of other optical elements) affect or influence light passing through them. not, or may be greatly affected. What is desired is similarity (equalization of refractive indices between multiple elements) to minimize refraction. Even so, partial refraction may appear, for example, in FIG. Here, lightwave F differs from lightwave E in that it is not, like lightwave E, reflected light from barriers 122 and/or 123 . Lightwave B is shown as being both reflected and refracted. The selection of materials, sizes and shapes of some structures relative to each other can improve efficiency in light emission and/or light capture. To manage reflectance and/or refractive index relative, in relation to other optical properties (e.g., refractive index for reflectance, reflectance for refractive index, etc.) It is possible to support

Returning to the discussion of variations on the adhesive, FIG. 1D provides a first example of an adhesive (composite adhesive) 113 that may be used with those described herein. The adhesive layer 113, in this embodiment, is a double-sided adhesive, which is applied to the bottom surface 102 and the second side of the device 100, The second side is of a different type (different from the adhesive or adhesive applied to the bottom surface 102) adhesive, possibly to be adhered to the patient's body skin (not shown). It will accompany the body (adhesive). Different types of adhesives may be used, in that the material chosen to which the adhesive layer (adhesive 113) is to be adhered differs. typically includes a circuit or board material for connection to the device 100 and patient skin on the patient side (bottom 102) (not separately shown). and A protective backing 114 can be used on the patient side until patient application is desired. It should be noted that in many applications the cohesive 113 is conductive in only one or substantially one direction, e.g., an axis perpendicular to its cohesive surface. is anisotropic in that is desirable. Thus, good electrical contact for signal transmission can be achieved by the aforementioned adhesive to the aforementioned electrical contacts or electrodes 108 , 109 and 110 . It should be noted that corresponding one or more light apertures 111b/112b are shown inside the example cohesive 113 in FIG. 1D to enable pulse oximetry, Light passes through the optical apertures 111b/112b and into/through the layer (strip layer) 105 for transmission of optical data typically related to arterial blood oxygen saturation. It is to transmit so as to cooperate with the light conduit 111a/112a which exists so as to penetrate therethrough.

In some embodiments, the adhesive 113 can be placed or installed on the device 100 substantially permanently or with some degree of replaceability. In some embodiments, the device (device 100) does not have the adhesive 113 (or in some implementations In embodiments, the one with the cohesive 113 can be reusable. In many cases of this kind, the adhesive layer 113 can be peeled off and replaced with another one prior to each subsequent use (the next use of the device). Although possible, re-use of and with (re-use of layer 113 only and re-use with layer 113) of layer (adhesive layer) 113 is not hindered. During the first use or subsequent uses of the device with the replaceable adhesive layer 113, the user applying the device to the patient, such as a physician or technician, or the patient himself, is responsible for establishing electrical continuity. A conductive transfer adhesive 113 is attached to the patient side 102 of the device 100 . The protective backing 114 is then peeled off and the device is applied to the patient and activated.

Activation of the device after being attached to the patient/wearer can be done in many ways, and in some ways it can be preset as follows: No affirmative interaction is required from the physician, patient, or others because of inertia (inertia, inertial resistance, inertia of blood flow) activation and/or Activation by a pulse oximeter, followed by activation of the device automatically, in one example, is triggered by a sufficiently small input (motion in the case of an inertial frame, or pulse oximetry). a button at the location of the access passage 106 or in close proximity to the electronics (electronics 103). Within a certain location, the patient can be placed to enable or disable the device, or to mark certain events as desired. In one preferred embodiment, the device is worn for a period of time, such as two weeks, to acquire data substantially continuously or is preferred and established in or by the system. It can be worn intermittently at intervals of time such that it is worn.

Upon completion of the monitoring period, the physician, technician, patient, or other human then removes the device (device 100) from the patient's body and, in some instances, removes the adhesive. In some cases alcohol is used to remove and establish a data transmission connection for data transmission, thereby downloading said data, said data transmission, for example, by wireless communication, or This is done by inserting/connecting a USB or similar data connector. The data are then processed and/or interpreted, and in many cases the data are interpreted immediately as required. The on-board power supply can include a battery, which can then be recharged between uses, and in some embodiments the Consider that the battery can be fully recharged quickly, such as within about 24 hours, after which the device is ready for the next patient or next use. is possible.

Here it is possible to use several different conductive adhesives. Figures 1E, 1F and 1G show one such alternative conductive adhesive 113a, shown in bottom view in Figure 1E and in side view in Figures 1F and 1G, respectively. (shown being coupled to device 100 in FIG. 1G). In some embodiments, the conductivity thereof can be anisotropic as described above, and in some examples the Z It is predominantly, if not totally, conductive in the axial direction, the Z-axis direction being perpendicular to the plane of the paper in FIG. ), and/or perpendicular or transversally to the axis of device 100, which in the embodiment of FIG. 1F is shown to be long and horizontal.

This particular embodiment has a composite (two or more different parts, heterohybrid, composite) cohesive body 113a, which itself has one or more non-conductive layers. It has a portion 113b and one or more conductive portions 113c. The adhesive composite 113a has one side to be adhered to the patient and the other side to be attached to the device, as described above for the adhesive 113. Both sides can be used to adhere to the bottom surface 102 of 100 (see FIG. 1G) so that one or more conductive portions 113c are integrally mounted on device 100 for electronic monitoring. It can be placed in electrically communicative and/or electrically conducting contact with a plurality of electrodes. Although the electrodes work better when they are electrically isolated or insulated from each other, each electrode is in electrical contact or electrical communication with the patient's skin, In some embodiments, the adherent is further arranged in a more specific manner, as described below.

As shown in FIGS. 1E and 1F, the mutually insulated conductive portions 113c are arranged to be separated from each other by non-conductive body portions 113b. These (these conductive portions 113c) are then seen from some of the previous examples, and as shown more specifically and systematically in FIG. 1G (note that the scale is The adhesive 113a is exaggerated and thus not necessarily shown to match exactly with the electrodes of the device 100). In some examples, the plurality of electrode areas 113c (the electrode areas, the plurality of conductive portions described above) is a conductive hydrogel (hydrogel, a hydrophilic polymer containing a large amount of water), It may or may not be tacky, and in some examples the electrode areas 113c may be of a tacky conductive material. The adhesive conductive material is, for example, 3M Corporation's 9880 Hydrogel adhesive (3M Company, St. Paul, Minn.). The electrode areas 113c can then be insulated from each other by a non-conductive material 113b, which can be, for example, 3M Corporation 9836 tape or 3M Double-sided Transfer Adhesive 9917 (3M Company, St. Paul, MN). If another layer 113d is additionally used, that layer 113d can be 3M 9917 adhesive with a non-conductive material 113b of 9836 material. Due to their structure, the electrical path in the Z-axis direction (perpendicular to the plane of the paper in FIG. 1E and vertical/lateral direction for FIGS. 1F and 1G) for multiple electrode areas 113c. As the impedance decreases, the electrodes move in the X/Y (X/Y, X or Y) direction (see FIGS. 1E, 1F and 1G, in FIG. 1E in the same plane as the paper). direction, which in FIGS. 1F and 1G are horizontal and perpendicular to the plane of the paper) has the effect of increasing the impedance of the electrical path. Thus, not only is the device affixed to the patient by an adhesive strip consisting of a composite (2 or more different parts, heterogeneous, composite) adhesive portion, but also the plurality of electrodes are connected to the patient. It can also be ensured that it is electrically conductively connected to the plurality of conductive portions of the adhesive strip, whether one electrode or three electrodes as shown, here Additionally, the combination of conductive and non-conductive portions may provide reduced signal noise and/or improved noiseless characteristics. Noise is generated when the electrodes are allowed to move relative to the skin, i.e. the electrodes electrically transmissible/connected electrically to the skin through the gel. The electrodes can move relative to the skin and thus generate noise. However, by connecting one or more conductive adhesive portions in the composite adhesive body to the respective corresponding electrodes and then substantially immovably attaching the electrodes to the skin, the electrodes are substantially fixed to the skin. until the electrode remains fixed to the skin, thereby reducing or eliminating movement of the electrode relative to the skin. When such motion is eliminated, the noise is then removed, thereby providing a clean signal, which allows monitoring of cardiac P-waves. possible, the cardiac P-wave enhances the ability to detect otherwise undetectable arrhythmias. Further explanation is provided below.

In some embodiments, an optional additional structure 113d having component connective and/or electrically insulating properties is shown in FIGS. 1F and/or 1G. , which further provides structural and insulating isolation between the plurality of electrodes mounted on the device 100 on its bottom surface 102. It is possible (see FIG. 1G). In Figures 1F and 1G, structure 113d is shown in a separate state, but structure 113d does not include the insulative adhesive, the non-conductive portion, and the main body shown in those figures. part) 113b.

Still another one may be used for the adhesive part. In some embodiments, composite adhesive stripes are used that have one or more motion artifact mitigating properties. may A typical ECG attachment system (mechanism for attaching the ECG to the human body) uses a conductive gel that is placed over the electrodes. However, in this embodiment, a hydrogel adhesive (hydrogel adhesive, hydrogel adhesive) may be used, and the hydrogel adhesive is contained in one continuous sheet. embedded, the continuous sheet is composed of a laminate of a plurality of adherents, the laminate is a selected area of the device or the entire footprint of the device (the entire footprint, the covering the entire trajectory of the portion covered by the device as it is moved over the skin). The hydrogel adhesive itself has strong adhesive properties, and the hydrogel adhesive can be applied with adhesives (any adhesive including the composite adhesive stripe). The fact that the device is combined with the complete coverage may ensure a strong bond between the device and the patient's skin. Contributing to mitigation of motion artifacts may be another method of placement of the device vertically on the sternum, which The placement method results in reduced motion artifacts for one or more of ECG signals, photoplethysmograms and oxygen saturation signals.

In some embodiments, the composite adhesive improvement has a water-proof encapsulation of the hydrogel adhesive to prevent ohmic impedance drop causing signal amplitude reduction. may This may also help prevent degradation of hydrocolloid adhesives. In particular, several layers may be used, as shown in FIGS. 1I and 1J as another non-limiting example of the invention. In what is described herein, the first layer is a hydrocolloid, an adhesive designed for long-term skin contact by absorbing sweat and cells. And the second layer, which is also designed for long-term skin contact, insulates the third layer from skin contact. A smaller dimension of the second layer than the other layers forms a gap between the first and third layers. When the first and third layers are bonded together, a watertight seal is formed around the second layer. This layer, the second layer, further insulates the Hydrocolloid (first layer) from the Hydrogel adhesive (fourth layer) and the Hydrocolloid (first layer). layer) to protect the adhesive properties. In that case, the third and fifth layers will each be a generally waterproof layer, and they will each be an electrically insulating double-sided adhesive. These two layers encapsulate the hydrogel adhesive (fourth layer) and prevent "electrical shorts" as described below with respect to the fourth layer. The fourth layer is the hydrogel adhesive, which is the conductive element in this embodiment. The three lands (lands, isolated regions, islands) of the hydrogel adhesive of the fourth layer must be kept electrically insulated from each other. However, since the hydrocolloid in the first layer absorbs sweat, the first layer also becomes conductive, and the first layer forms an "electrical short circuit" between the three lands of the hydrogel adhesive in the fourth layer. , which leads to a decrease in signal amplitude. However, this "electrical short" may be prevented by the third and fifth layers, as described above.

In one or more additional or alternative embodiments, temperature is the parameter sensed by the embodiment. This temperature measurement may be performed using a single sensor or multiple sensors, as described herein. In some embodiments relating to temperature, the temperature of the infant or neonate may be the data sought for capture, or the temperature, such as the temperature of the infant or neonate, may be It may be used with other users, adults or others.

Infant and/or neonatal temperature sensing can be of great assistance in health monitoring. Using the forehead or other areas may be one suitable use for such applications. Another possible combination of uses is to measure the body temperature of both the infant and the mother involved in so-called "Kangaroo Care". You may have the method and apparatus of Evidence exists that preterm infants benefit more from constant contact with the skin of their parents or biological mothers than from being placed in an incubator. There is also evidence of low mortality.

A device 100a for temperature sensing at two locations (dual, multiple in terms of location and time) is attached to an infant. The harness 1000 and mother 1010 or ambient air (ambient air adjacent to the device) 1011 are shown in the accompanying drawing, FIG. 1R. Substrate 1105 is desirably a small, flexible circuit board, having dimensions of about 20 mm by about 30 mm in some examples. The circuit board 1105 may be arranged to include a circuit portion 1103 that, for example, measures relative XYZ position and/or has a sensing acceleration and/or Bluetooth or other wireless communication for data/signals, and in many instances It also has a battery that is replaceable and/or rechargeable to extend the usage time, which extended usage time is, for example, 7 days with continuous monitoring (Fig. 1R shows the Not all of the multiple options for components are shown separately from each other). Device 100a may be attached to an infant using an adhesive, such as the composite adhesive 2 shown in FIG. 1R. 1113, which consists of different parts, and may be, for example, disposable, medical grade, and double sided.

Each of the two temperature sensors (temperature sensors) 1111a and 1111b are positioned on two alternative opposing sides (parent side and infant side) of the apparatus 100a. 1101, 1102, and the temperature sensors 1111a and 1111b may be thermally isolated from each other, while the temperature sensors 1111a and 1111b are often It is also waterproof, watertight or water resistant. A thermally shielding or insulating layer (heat shielding/heat insulating layer) 1103a realizes a heat insulating effect for the electronics (circuit portion) 1103 and/or the two temperature sensors 1111a and 1111b. good too. Additional spacers 1103b are passed through the heat shielding/insulating layer 1103a to provide a throughway for electrically conducting the temperature sensor 1111b to the electronics layer (electronics layer, circuitry portion) 1103. You can set it to A silicone bead 1104 may be placed for thermal insulation and to help provide a waterproof and water resistant seal on the "infant side" 1102. A silicone cover 1121 may also provide a waterproof or water resistant barrier on the “parent side” 1101 . Temperature sensor 1111b located on the "parent side" or top or exterior side 1101 may be slightly protruding relative to the surface of cover 1121, in which case it is often Embodiments may have a thin/thinner layer covering the protrusion of the temperature sensor 1111b and made of a covering material and/or silicone. good. The temperature sensor 1111a located on the "child side", i.e., the patient side, i.e., the circuit side 1102 protrudes beyond the surface of the adhesive (adhesive 1113). past the adhesive, or protruding through the adhesive and/or placed exposed, or additionally/alternatively waterproof or watertight Alternatively, it may be coated with a thin layer of protective agent to achieve water resistance.

The thermally insulating layer (1103a) may perform one or two or more functions. It, its heat shield/insulation layer 1103a, reaches an equilibrium state (equilibrium, a state in which the temperature of the "infant side" temperature sensor 1111a coincides with the temperature of the infant) and it It may be possible to provide an infant's "core temperature (the temperature of internal organs, etc., which are not easily affected by environmental temperature)" with high accuracy. It (It, the heat shielding/insulating layer 1103a) may additionally or alternatively shield the measurement of the infant's body temperature from the mother's body temperature or the outside air temperature. It is not a requirement that the "mother's side" temperature sensor 1111b provide an accurate mother's core body temperature. Typically, the function of the temperature sensor 1111b is to distinguish between situations in which the infant is in proper direct contact with the mother's skin and situations in which the infant is not in relative contact with the mother. It would provide a relative measurement (the difference between the infant's temperature and that of the mother) to determine whether the infant is in contact or relatively out of contact. If the infant is misoriented but still "in the pouch" (the infant being held by the mother, in the mother's stomach or bosom), the sensor, The temperature sensor 1111b) measurement will represent that environment's ambient temperature, such as the temperature around the device in the pouch. When the infant is outside the pouch, the sensor (temperature sensor 1111b) reading will represent the room ambient temperature (the temperature in the room surrounding the device). The relative differences (the relative relationship of temperature sensor 1111b readings to temperature sensor 1111a readings) determine what position the infant is in, i. in contact or in close association (but not in contact with the mother) with the mother in a controlled (allowed) environment of "cuddle"; Alternatively, it can be interpreted as providing an indication of being outside the pouch in an environment further away from the mother.

Alarms (e.g., alarms, stimuli for alerts) from Bluetooth® or other wirelessly connected devices can be used by mothers (or health management professionals) to inform their infants that they are no longer desired. It may be used to warn that the posture is incorrect or that the infant is no longer positioned inside said "(pouch, pouch, mother's bosom)".

Some alternative implementations of those described herein can have a driven right leg (DRL) electrocardiogram (ECG) circuit, the DRL The ECG circuit has one or more electrodes that are used only in the chest ("Driven Chest Electrodes"). In addition to the plurality of electrodes used to measure a single or multiple lead electrocardiogram signal, the device 100 is sensitive to common mode noise, In order to reduce common-mode noise, common-mode signals mixed as noise), a separate electrode can be used, such as the reference electrode 110 (e.g., FIGS. 1A, 1C, 1D and 1G) can be used. This type of electrode can function in a similar manner to commonly-used DRL (driven right leg) electrodes, but in this embodiment the patient It is placed on the patient's chest rather than on the right leg of the patient, but this third/reference electrode can nonetheless serve as the foot electrode. Thus, the chest electrode can be considered a proxy right leg drive electrode that mimics the right leg electrode and/or performs the same function in place of the right leg drive electrode. It is possible. A circuit, or part of an overall circuit, designed to operate in this manner is intended to ensure circuit operational stability and adjust overall frequency response characteristics. In addition to filtering, it is possible to have multiple amplifier stages to achieve gain. Such circuitry can be biased to adjust the common mode bias of the electrocardiogram signal. This embodiment with chest drive electrodes uses a differential or instrumentation amplifier to reduce common mode noise. amplifier, measurement amplifier) can be used in combination. In this embodiment, a sense electrode can be used as one of multiple ECG electrodes. Alternatively, the differential ECG signal is referenced to ground or to some other known voltage. other known voltage as a reference voltage), it is possible to use a single-ended electrocardiogram amplifier. It is possible.

As shown in FIG. 2, a circuit or sub-circuit 200 having a transistor 201 may be such a circuit (known as a module), thus As further shown in 2A, it may comprise a sense electrode 202, a drive electrode 203, and an amplifier 204. FIG. Both the sensing electrode 202 and the driving electrode 203 are placed on the patient's chest such that they are electrically connected to the patient. Amplifier 204 may have gain and filtering. The output of the amplifier 204 is connected to the driving electrode 203, the inverting input of the amplifier is connected to the sensing electrode 202, and the non-inverting input of the amplifier is connected to the bias voltage 205. there is Amplifier 204 maintains the voltage of sensing electrode 202 at a level close to the bias voltage. The electrocardiogram signal can then be measured with some other electrodes. While it was certainly true that the use of some anisotropic adhesives mentioned above improves the conductivity, here, in addition or alternatively, this A third electrode is used as a proxy for the right foot electrode (i.e., a proxy right foot drive electrode that performs the same function as the right foot drive electrode), thereby reducing the otherwise available Impossible signal reception can be achieved. Thus, a clean signal allows for the reception of cardiac P-waves, which enhance the ability to detect arrhythmias that would otherwise be undetectable.

A further explanation of the circuit comprises that shown in FIGS. 2B and 2C, which illustrate several alternative non-limiting aspects of the invention, which are illustrated in FIGS. In another embodiment, three electrodes E1, E2 and E3 adjacent to each other can be used to pick up ECG signals, one of the electrodes being a conventional ECG monitor ( ECG monitor, electrocardiograph) serves as a distant limb electrode. Since the electrode-patient interface has associated impedances (Re1 and Re2), current passing through this interface will generate a voltage difference between the patient and the electrodes. The current circuit can use the sensing electrode (E1) to sense the patient's voltage. Since this exemplary circuit node (node) has a high impedance to circuit ground (GND, ground point, earth), little current flows through the electrode interface. , thereby minimizing the amount of voltage drop between the patient and this node. A first of these alternatives is a non-limiting circuit (FIG. 2B) which further comprises an amplifier (U1), the low impedance output of which is , is connected to a drive electrode (E2) which is a separate electrode (separate, insulated from the others). The amplifier uses negative feedback to adjust its drive electrode such that the patient voltage (measured by sense electrode E1) is equal to the bias voltage (V1). This effectively allows the patient voltage to be maintained at a height equal to the bias voltage despite the presence of a voltage difference between the drive electrode (E2) and the patient. This can have a voltage difference caused by the power line-induced current between the driving electrode and the patient (via Re2). This configuration differs from conventional "DRL (Right Leg Driven)" circuits in at least two respects: the drive electrodes are placed on the patient's chest (rather than on the patient's right leg); point and the ECG signal was a single-ended (one of the amplifier circuits grounded) (not differential) measurements taken from the third electrode (E3). It is a point. In the chest-placed example, all the electrodes are placed on the patient's chest, so a small chest-placed device can have all the electrodes needed for an electrocardiogram measurement. One potential advantage of single-ended measurements is the gain and filtering circuitry (U2 and its associated components (Fig. 2C)) to extract the ECG signal prior to recording (ECG output). Requires only a small number of parts to condition the characteristics, and for component tolerance matching less sensitive. Figures 2A, 2B, and 2C are non-limiting examples of the invention, and they are not intended to limit the scope of the claims herein, because other Other circuits can be formed with that in mind by those skilled in the art, and such circuits still depart from the spirit and scope of the claims herein. because it doesn't.

In many embodiments, the system described herein can have other circuitry operable with the plurality of electrocardiogram electrodes, and thus the system can can be accompanied for the purpose of providing multiple time histories (trace, time record, waveform) synchronized with each other, which The time history (trace, time record, waveform) includes i) electrocardiographic p, qrs and t waves, ii) oxygen saturation as measured by pulse oximetry, and/or iii ) xyz acceleration to provide an index of physical activity. In some embodiments, the entire system may have a continuous run time as long as two weeks (or longer) during which data collection may occur. Some implementations can be designed to provide as many as 1000 uses or more. Some other embodiments may be operable after or during exposure to fluids or moisture, and in some such examples may be water resistant, waterproof or It is watertight and in some cases remains fully submerged and fully operational (in low salt water). Some other implementations have high speed data transfer, in some examples using HS USB for complete data transfer in less than about 90 seconds. Typically, rechargeable batteries can be used.

Yet another embodiment can have an electronic "ground", which in the devices described herein is completely mounted on a flexible circuit board. and its function as a ground plane is provided by a plurality of coaxial ground leads adjacent to the plurality of signal leads. can be realized. A major contribution of this type of grounding system is that it allows the device to follow the skin and have the necessary flexibility to be worn.

For an electrocardiogram, ie EKG or ECG, some embodiments can have an input impedance of greater than about 10 MegΩ, and some embodiments use a bandwidth of 0.1-48 Hz. and some implementations may have a sampling rate of approximately 256 Hz and may achieve 12-bit resolution. For PPG and pulse oximeters, operation is at wavelengths of 660 nm and 940 nm, SpO2 range of approximately 80-100 (percutaneous arterial oxygen saturation range), bandwidth of 0.05-4.8 Hz, sampling at 16 Hz. - can be done with 12-bit resolution. For accelerometers, 3-axis measurement can be employed, in some embodiments using a range of plus or minus 2G, using a sampling rate of 16 Hz and a resolution of 12 bits. is possible.

For pulse oximetry (arterial blood oxygen saturation), ambient light subtraction of PPG (PPG, plethysmography, photoelectric plethysmography, plethysmogram signal, PPG signal) From the signal, options may be included for processing to cancel the noise signal representing the noise by the circuit). The text describes a method and circuit for reducing errors in pulse oximetry due to ambient light, which is the optional circuit shown in FIG. 2D. . Here, a correlated double sampling method is used to remove the effects of ambient light, photodetector (photodetector, photoreceiver, photodiode sensor 112c) dark current and flicker noise. Illustrated as usage.

The schematic shown in FIG. 2D may first be used when the noise signal representing noise may be measured. The light source is turned off, switch S1 (first switch) is closed and switch S2 (second switch) is opened. This allows a charge proportional to the noise signal to accumulate in C1 (C1, the first capacitor with capacitance C1). After that, the switch S1 is opened. At this point, the voltage on C1 is equal to the voltage of the noise signal. The light signal representing light is then measured. The light source is turned on, switch S2 is closed, and charge is allowed to flow in series via C1 and C2 (C2, the second capacitor with capacitance C2). Switch S2 is then opened and the voltage on C2 is held until the next measurement cycle is started in case the whole process is repeated.

If C1 is much larger than C2 (C1 is much larger than C2, capacitance C1 is much greater than capacitance C2, C1/C2 is well above 1, C2/C1 is sufficiently close to 0), then Almost all of the voltage, the voltage of the light signal, will appear on C2, and the voltage of C2 is the noise-free signal, the light signal with noise removed (s ) would match. If C1 is not much greater than C2, then the voltage on C2 is a linear combination of the previous value (p) of the voltage on C2 and the noise-free signal, i.e. (C2* s+C1*p)/(C1+C2). This is the effect of applying a first-order low-pass IIR (IIR, infinite impulse response) discrete-time filter (digital filter) to the signal (the optical signal). effect). If this filtering effect is not desired, the signal (the optical signal, voltage) held in C2 is simply (C2*s)/(C1+C2). , the optical signal) is measured each cycle, C2 may be discharged to bring the voltage on C2 to zero.

The circuit may use a transimpedance amplifier instead of the resistor R, a phototransistor instead of the photodiode, and FETs instead of the switches. Additional buffering, amplification, filtering and processing stages may be arranged after the output of this circuit.

At this point, some general methodologies may be understood in connection with FIG. They may be understood as passages. A flow chart 300 as in FIG. 3 shows some of the alternatives, where the initial manuever 301 is to attach the device 100 to the patient. may be. Certainly, this step may involve one or more of the aforementioned alternatives for attachment with an adhesive, but the adhesion is similar to that of 113 in FIG. 1D. 1E, 1F and/or 1G. Thereafter, as shown, traveling by flow line 311, data acquisition process 302 is performed. It should be noted that this step may be continuous or substantially continuous acquisition, intermittent or periodic acquisition, or one or more events at one time or time or interval. (a one time event collection). The method of acquisition depends on the type of data to be acquired and/or other features or alternatives, in one example, for the electrocardiogram example, where long-term amounts of data are desired. and, as in some cases of pulse oximetry, e.g., a relative single data point (one time or instant). or acquiring data representing one or more events in an interval) may be useful (e.g., if the saturation point is clearly low, a single saturation point As may be noted, it is certainly more typical to have comparative data showing trends over time).

Several alternatives then exist in FIG. 3, flow chart 300, the first alternative being data transmission processing 303 following flow line 312, this step is a device and/or system (not separately shown in FIG. 3, but a computing device such as shown in FIG. 4 below) that performs data analysis and/or storage from the device 100 and the like) may include communicating data wirelessly or by wire. A plurality of options (alternatives) branching from this point also appear, but the first option (alternative) is to move along the flow line 313 to the data analysis process 304, and the process aims at analyzing data to determine whether a patient is relatively healthy and/or to diagnose a patient's disease. Several computing systems, e.g., one computer (which can take many forms, whether portable, personal, mainframe, or otherwise). In any event, see FIG. 4 and textual description below) can be used for this analysis, although some analysis may be on the device 100 itself or internal to the device 100 itself. Sufficient intelligence can be built into the electronic components portion 103 of the device 100 so that it can operate in the . One non-limiting example of the scope of the invention is a threshold comparison, which for example compares with pulse oximetry (arterial blood oxygen saturation) and in this example, an indicator or alarm is all activated on/by the electronics portion 103 of the device 100 when a low (or, in some instances, perhaps a high) threshold level is reached. may be

A similar example is considered by an optional alternative flow path 312a, which itself branches into multiple portions 312b and 312c. Following flow path 312a, it will be appreciated that in the first example for flow path 312b, data transmission processing 303 is skipped, whereby analysis 304 is performed without substantial data transmission. . This describes on board analysis (analysis by device 100, analysis in situ, analysis on board), e.g., if the analysis follows the aforementioned threshold example, or , in some examples, depending on the amount of intelligence embedded on/within the electronics section 103, may have more detailed analysis performed. Another point of view is relative to how much transmission is involved, even if transmission processing 303 is used, and how much that transmission processing 303 At a level, from the patient's skin, via conductors 108, 109 and/or 110 and a plurality of traces 107, for analysis in the electronics section 103, It is only to the extent that data is transmitted to the electronic component unit 103 . In some other examples, of course, the transmission includes off-board downloading to other computing resources (e.g., FIG. 4) off-board (outside device 100). It is possible to have In some cases, such data off-loading (transferring the data to a peripheral device) allows higher computing power resources to be used for higher analysis. be.

Further alternatives can primarily include data storage, and if that data storage is used, the time and place remembered. Similar to intelligence, some storage or memory is available within/by the electronics portion 103 of the on-board device 100 or no storage or memory. Storage, if any, whether small or large, is made available on device 100 and flow path 312a to flow path 312c then accomplishes data storage 305. used to This step may precede transmission or parsing in many cases, but this is not essential (note that for some types of data, multiple flow paths may be used). together, in parallel or in series with each other if not simultaneously (e.g., flow paths 312b and 312c need not be employed entirely to the exclusion of the other), thereby saving and transmit or store and analyze without necessarily requiring that a particular process be completed before initiating the other process or before performing the other process in a manner other than said initiating can be done). Thus, after (or during) storage 305 is subsequently performed, flow path 315a is followed for stored data, which is then passed to operation 303 by flow path 315b. , is transmitted and/or the data is parsed by passing to operation 304 via flow path 315c. An example of such storage is often an example of on-board storage, but in this example data is acquired and then stored in local memory for analysis. , is off-loaded (data is transferred to the peripheral)/sent. As is frequently the case, this process can have long-term data storage, for example in the form of days or weeks or even longer, and thus the patient may be transferred to a doctor's hospital or other It is possible to have remote data acquisition when away from a medical facility. Thus, data can be obtained from the patient's real-world environment. Then, after data acquisition, the data is transmitted from storage on device 100 to a destination computing resource (eg, FIG. 4), the transmission being wireless, wired, or a combination thereof, such as by personal - Bluetooth or Wi-Fi connected to a computer (Fig. 4 for an example), which personal computer then transmits said data via the Internet for final analysis , to the specified computer. Another example has a configuration where the USB is connected to a computer, the USB is connected to a PC or mainframe (Fig. 4), and the USB is connected to the patient's computer or, for analysis, It may be connected to the doctor's computer.

If the amount of storage or memory on device 100 is low or non-existent (or even, in some instances, there is even a large amount of resident memory available), relatively soon after data acquisition: it may be necessary or desirable to transmit and/or subsequently store said data, where flow path 313a is experienced after execution of process 303 and/or data is transmitted and analyzed; In this case, flow paths 312 and 313 are experienced. If flow path 313a is used, then more typically the aforementioned data storage is internal/into a computing resource (not shown in FIG. 3, but see FIG. 4 below). It exists on a computing resource, and the computing resource is off-board (outside the device 100) (but on-board (inside the device 100)), and has memory as well. ), then any of flow paths 315a, 315b and 315c can be used.

A feature of what is described herein includes an overall system, which has one or more devices 100 and some computing resources (see, eg, FIG. 4), which Computing resources may be on-board device 100 or separate from device 100, in the latter case, e.g., personal or A mobile or handheld computing device (schematically illustrated in Figure 4), the entire system allows a physician or doctor to analyze and present acquired test data immediately and in-office. to achieve the ability to do). This allows, in some embodiments, on-site data analysis from the device without the use of a third party for data extraction and analysis.

Some alternative embodiments of what is described in the specification may thus optionally include a combination or combinations of hardware and software. Provision can be made for alternative multiple data source interpretations. As previously mentioned, the device 100 herein includes hardware that monitors one or more of various physiological parameters and then uses relevant data to Create and store a representation of the parameter. A system may then combine hardware, such as device 100 and/or some components of device 100, and software and computing resources (shown schematically in FIG. 4) to process physiological parameters. I have it. The system not only acquires data, but also interprets and correlates that data.

For example, an ECG time history showing the occurrence of a ventricular arrhythmia during strenuous exercise may differ from the same arrhythmia occurring during rest ( differently interpreted than the same arrhythmia during a period of rest (different from the ECG time history showing the same arrhythmia occurring during rest) have a nature. Blood oxygen saturation levels that vary greatly with movement (vary greatly with movement or rest) , especially at rest, may present with more serious conditions (symptoms). It is possible to use many combinations of the four physiological parameters, and if the software has the ability to visualize and highlight potential problems (things that may hinder the doctor's correct diagnosis), the doctor's diagnosis can highly support Thus, useful data interpretation can be achieved with the system described herein.

Among the features described above, those that can help achieve this goal may be incorporated into one or more of processes 303 and 304 of FIG. 3, in which: Data captured on device 100 can be transferred to a computing device (again, whether onboard device 100 or discrete from device 100, for example, as shown in FIG. 4) in a fairly straightforward manner. It can be sent/sent. For example, when a patient wearing a device (process 301) returns to a physician's office after an examination period during which data was acquired (process 302), the device One or more alternatives for transmission, e.g., via USB, to a computer (Windows or Mac) located in the clinic (which is outlined in FIGS. 4 and 5). described with reference to the detailed description of the invention), thereby allowing immediate analysis by the physician while the patient is waiting (note that device 100 is initially The device 100 remains attached to the patient until removed from the patient or pending transmission and analysis to determine if more data is desired. that is). In some embodiments, the data analysis time is relatively short, in some embodiments, about 15 minutes, and the data analysis is time sensitive to the physician's familiarity with the analysis software. A user-friendly GUI (Graphic User Interface) may be used to guide the physician.

An analysis/software package may be disposed to present test results to the physician in various formats. In some embodiments, an overview of the test results can be presented along with or in place of the more detailed results. In either case, a summary of the abnormalities and/or patient-triggered events detected will be presented as an overview: and/or may be provided as part of the more detailed report. Selecting individual anomalies or individual patient-induced events allows the physician to view additional details, including raw data obtained from the electrocardiograph and/or other sensors. The desired flexibility is realized. Said package further provides that the data is provided in industry standard EHR (EHR, Electronic Health Record, Electronic Medical Record) format with some annotations. It can also be printed and saved with .

In one embodiment, patient data can be analyzed using software having one or more of the specifications described below. Some alternative abilities are
1. data acquisition, i.e. loading of data files from the device;
2. Data formatting, i.e. converting the raw data format into an industry standard file format, whether for example ECG (xml), DICOM or SCP-ECG Processing (it should be noted that such data formatting may occur as part of data acquisition, storage or analysis, as well as transformation from one thing to another). ) (e.g., data may well be stored in compressed formats that require conversion or other forms of un-packing to perform analysis),
3. Data storage (whether stored locally, i.e. at the clinic/clinic level) or stored e.g. in the Cloud (the Cloud is an arbitrary choice, offline portable browser-based reporting (presentation, visualization, output)/analysis that runs on
4. analysis, in particular for example noise filtering (high-pass/low-pass digital filtering) and/or QRS (Beat) detection (in some cases for speed and accuracy , with continuous wave conversion (CWT)), and/or
5. Reporting (presentation, visualization, output) of data/analysis results, one or more graphical user interfaces (GUIs), perhaps more particularly an overall summary and/or an overall with summary statistics and/or patient-induced event abnormalities;
Strip views of anomalous data for blood oxygen saturation, stress correlation, or the like by time (incident, hour, interval, incident) (previous, next) view) at another level of detail; and/or allow caregivers to bookmark/annotate/note by time (incident, hour, interval, incident). and/or have the ability to print.

In addition, with respect to alternatives in which the hardware is combined into its own software package, there are:
i) one software package on the device, electrocardiogram (right foot driven and/or p-wave, qrs-wave and/or t-wave) or oxygen saturation or xyz acceleration , are configured to store a number of measurements obtained from a plurality of data signals obtained from one or more of the ones synchronized with each other, thereby allowing a physician to determine the plurality of measurements. (e.g., in some instances, at intervals of 1-2 weeks), whereby the patient's that can provide useful information about how active a person has been.
ii) an alternative for managing real-time transmission of said real-time measured parameters to a nearby station or relay station. and/or
iii) Off-device electrocardiogram analysis software intended to recognize arrhythmias.

Such software may be industry-understood software and provided by third parties, or may be generated and transmitted by and/or received from wearable device 100 . It can be designed specifically for the data FDA 510(k) clearance is desirable throughout testing using standard (MIT-BIH/AHA/NST) arrhythmia databases. Such software provides one or more of automatic ECG analysis and interpretation, ECG signal processing, QRS detection and measurement, QRS feature extraction, classification of normal and ventricular extrasystoles, heart rate measurement, It can be configured to do so by providing several callable functions for PR and QT interval measurements and rhythm interpretation.

In many embodiments, the software is configured to provide one or more of the plurality of measurements and/or one or more of the plurality of measurements. wherein the plurality of measurements are:

Table 1:
1. heart rate minimum, maximum and average;2. Average QRS width3. Average value of PR interval4. Mean value of QT interval5. Mean ST Deviation Further, the software can be configured to recognize a wide variety of arrhythmias, such as the following.

Table 2A:
1. sinus rhythm 2. Sinus rhythm + IVCD (intraventricular conduction defect)
3. Sinus bradycardia4. Sinus bradycardia + IVCD
5. 6. Sinus tachycardia. Pulse stagnation (PAUSE)
7. Unclassifiable Rhythms8. artifact

The first group of eight types of arrhythmias described above are the types of arrhythmias that are recognizable even in the absence of a recognizable P-wave. They are the type of arrhythmia commonly recognized by several products already in existence in the outpatient monitoring market that the applicant proposes to address.

A second set or group of arrhythmias, described below, may require P-waves that are both recognizable and measurable. Some implementations of this can be configured to be able to detect and recognize these arrhythmias, where the device 100 detects P-waves, as described above. the detection of which depends, of course, and, for example, on whether the intensity of the P-wave is affected by the placement of the device 100 or the physiological state of the patient. there is a possibility.

Table 2B:
9. Atrial Fibrillation/Atrial Flutter Systemic Vascular Resistance SVR (slow)
10. Atrial fibrillation/atrial flutter ECG R coefficient of variation CVR (normal rate)
11. Atrial fibrillation/atrial flutter RVR (fast)
12. 1st degree atrioventricular block + sinus rhythm 13 . 1st degree atrioventricular block + sinus tachycardia 14 . 1st degree atrioventricular block + sinus bradycardia15. 2nd degree atrioventricular block 16 . 3rd degree atrioventricular block 17 . Premature atrial contraction 18 . supraventricular tachycardia19. Ventricular Premature Contractions 20.2 Coupling Ventricular Premature Contractions (COUPLET)
21. ventricular double pulse 22. ventricular triplicate 23. Intrinsic ventricular rhythm 24 . ventricular tachycardia25. slow ventricular tachycardia

Additionally, in alternative software implementations, some screenshots are the output of the device and displayed as images on the monitor screen. An example of a depiction of an object is shown in FIG. A first alternative of this kind is shown in FIG. 5A, which uses a patch device, such as device 100, to FIG. 4 is an example screenshot showing acquired electrocardiogram and oxygen saturation data. FIG. A very clean signal is shown (no filtering or smoothing was done on this data). Different p-waves are also shown (three of them are shown as an example with arrows). P-wave detection can be crucial for ECG anomaly detection. Oxygen saturation measured by pulse oximetry is illustrated on the lower plot. This is data acquired by a device worn on the chest and is acquired synchronously with the electrocardiogram data described above.

Another alternative is shown in FIG. 5B, which is an example screenshot for the analysis software. This is a sample of electrocardiogram data obtained from record 205 of the MIT-BIH Arrhythmia Database. In the Event Occurrence Summary column (top left), five types of abnormalities (in addition to the normal sinus rhythm (NSR)) are visible as analyzed by the analysis system. This column also shows the number of occurrences of each anomaly, the total duration of each anomaly in the full ECG, and the percentage of time each anomaly occurs in the full ECG. To see several specific instances (cases, phases, scenes) of each anomaly, the user doubles the specific line in the Event Occurrence Summary column, as shown in FIG. 5C. click.

As previously introduced, FIG. 5C is an example screenshot showing a specific instance of ventricular tachycardia. An electrocardiogram plot automatically navigates to a particular time within the electrocardiogram waveform, marking the start and end of that event. More detailed data for this specific event are now presented in the Occurrence Details column, which includes HR Average, Maximum (HR Max) and so on. To view several instances of another abnormality in this ECG, the user clicks in the row labeled Ventricular Premature Beats (PVC) in the Event Occurrence Summary column, as shown in FIG. 5D. is possible.

As previously introduced, FIG. 5D is an example screenshot showing a specific instance of Premature Ventricular Contraction (PVC). This shows multiple occurrences of that PVC. The start time column (top middle) shows all instances of PVC occurrence in this ECG and lists the start time for each occurrence. In this case, the user can click on the PVC starting at 00:15:27 (11th occurrence). The ECG graph automatically jumps to the time, thereby displaying and indicating multiple PVC instances within the waveform. Since there are 3 instances of the PVC in this time slot, all 3 occurrences are marked.

As noted above, in one aspect of some of the developments described herein, the electrocardiogram signal acquired synchronously with the pulse oximetry signal is used specifically for the pulse oximetry data. In some situations where the sensor is placed in some noise prone areas of the patient, such as the chest, the purpose of reducing noise in the pulse oximetry signal and some of the oxygen saturation It can be used for the purpose of allowing calculation of any value. In some embodiments, this aspect can be achieved by the following steps: (a) multiple heart beats, periods between pulses; ); and (b) measuring one or more pulse oximetry signals over a plurality of heart beats, said electrocardiogram signal and said one or more pulse oximetry signals being measured against each other over one or more heart beats. (c) a constant component and a primary periodic component, a plurality of periodic or alternating components of each of said one or more pulse oximetry signals; synchronizing a portion of the electrocardiogram signal and the one or more pulse oximetry signals with each other to determine the highest amplitude primary periodic component of the electrocardiogram signal; (d) some of the constant components and some of the primary components of the one or more pulse oximetry signals; and determining oxygen saturation from periodic components. Measuring electrocardiogram signals and multiple pulse oximetry signals can be performed by some embodiments of some of the devices described herein. In particular, the plurality of pulse oximetry signals can be a reflective infrared signal and a reflective red light signal collected by the photodetectors of the devices described herein. Some alternatives may have some other color, eg green, in addition to or instead of one or both of red and infrared. Some such options are detailed below.

Intervals of the pulse oximetry signals, corresponding to heartbeats, are defined as those pulses Detecting the pulse oximetry signals by comparing the pulse oximetry signals with electrocardiogram signals synchronous with them (determine )Is possible. For example (not intended to limit the scope of the present invention), a plurality of consecutive R wave (QRS wave) peaks of the synchronized electrocardiogram signal have the plurality of intervals. interval), but other features of the same electrocardiogram signal can also be used. Once the intervals have been identified, the numerical values measured for the intervals and corresponding to each other between the intervals values at corresponding times within the intervals values over time) are averaged to reduce signal noise and to reduce the stationary components ("direct current") of the pulse oximetry signals (each pulse oximetry signal). and the plurality of primary periodic components (the one having the largest amplitude among the plurality of periodic components, ie, alternating current components, the primary periodic component) ("alternating current More reliable numbers have been obtained for the AC component (sometimes referred to as the "AC component"), see, for example, Warner et al., Anesthesiology, 108: 950-958 (2008). See The number of signal values recorded in an interval depends on the signal sampling rate of the detector and processing electronics employed. In addition, since the plurality of intervals may differ from each other with respect to their respective durations, the process of averaging to calculate an average value may be performed by averaging the plurality of intervals. It can be applied to a subset, which is a set of numerical values less than the set of multiple numerical values present in the entire interval). As described below, multiple oxygen saturation values can be calculated from the DC and AC components described above using conventional algorithms. The total number of beats or intervals within which some of the above averages are calculated may vary significantly, as will be discussed below. In some embodiments, multiple signals obtained from one or more heart beats or one or more intervals can be analyzed; In can be analyzed multiple signals obtained from multiple beats or multiple intervals, and in some embodiments the number of beats or intervals ranges from 2 to 25 or within the range of 5 to 20 or within the range of 10 to 20.

As mentioned above, by the method of pulse oximetry (arterial blood oxygen saturation, pulse oximeter, measurement of arterial blood oxygen saturation), several A photoplethysmogram signal is measured. the direct current component (DC, non-pulsatile component) or the average value is estimated and subtracted (subtracted from the pulse oximeter signal, the PPG signal, the original signal, each of the two signals, etc.); , the ratio of AC (such as the ratio between the two signals with respect to the pulsatile component) of the pulsatile signal, said periodic component, said alternating component, non-stationary component, fluctuating component, pulsating component, is estimated and/or averaged. linear regression between two signals (the two signals, two pulse oximetry signals, two photoelectric plethysmogram signals, two light waves of different wavelengths received by the sensor, etc.) ) can be used as described below. However, performance (the performance achieved by its linear regression) is limited due to the presence of noise in both the red light and the infrared light that are close to each other. Photoplethysmography with green light (approximately 550 nm) employs motion noise because the light is absorbed more by blood than by water or other tissues. high resistance to motion artifacts, noise caused by motion of the patient during motion); But the difference between oxygenated (enriched with oxygen) and deoxygenated (deoxygenated) blood is the spectrum (spectrum of light, spectrum of electromagnetic waves, etc.) Within our green region there is much less than in the red region. In another example, long time averages of the green PPG signal (or red light/(or) infrared light, long time averages of the intensity of each signal, the length of the data represented by the waveform) A time-averaged value, time-averaged value)) (described later) may be used to measure the shape of the pulsatile signal. A weighted average (a value obtained by synchronously weighting a plurality of wavelength signals) for any number of wavelengths that are different from each other (e.g., green light, red light, and infrared light) is calculated as described above. It may be used to estimate the shape of the pulse wave.

In some further embodiments, a linear regression algorithm (linear regression method, a technique that analyzes correlations between multiple factors using linear regression equations) is used to measure oxygen saturation (Oxygen Saturation). may be used for In this sense, either or both of the patient's ECG signal and/or the green (or other color) LED-based PPG signal may be used. For the first example, ECG signals may be used to measure when heart beats occur, when heart beats occur, and where in time heart beats occur. The two of photoplethysmogram signals, the two selected volume pulse wave signals, the two PPG signals, the sensor received , curves 600 and 602 in FIG. 6A), for each of the two lightwaves with different wavelengths, curves 600 and 602 in FIG. acquisition of an average value between mutually synchronized portions in association with timing). In that case, a plurality of ensemble averages obtained as a result (the ensemble averages, the average values of the two volume pulse wave signals obtained for each heartbeat occurrence position (the two volume pulse wave signals are synchronized with each other values obtained by synchronously averaging multiple signals, and multiple signals representing the same patient's vital signs in chronological order. The linear regression method for the average value obtained by synchronously sequential averaging, the average value between signals) is used as a linear gain coefficient between the two signals (the two signals, the two volume pulse wave signals, etc.) ( may be used to determine the linear gain factor). This linear gain factor can be used to measure the patient's oxygen saturation.

Alternatively and/or additionally, if a photoplethysmography (PPG) (photoplethysmography) with green light (approximately 550 nm) is performed, the PPG signal can be used to measure the shape of the pulsatile signal. may be used to This low noise signal is then used as the independent variable for the linear regression (for the linear regression line) for both the red light signal and the infrared light signal. In order to compare the linear regression results and the linear regression results for the infrared light signal with each other, it may be used as a variable common to the linear regression results. The ratio of the two regression results (two regression coefficients) is an estimate of the correlation coefficient between the red and infrared light signals. As described in this paper, the noise is ensemble-averaged over multiple heart beats (over multiple heart beat timings) to represent the same patient vital signs in time series. synchronous averaging between signals, synchronous averaging across multiple wavelength signals) (see e.g., discussion of multiple frames below). want to be). In addition to or instead of using ECG signals to measure heartbeat timing, green light wavelength PPG signals may be used. Alternatively, any number of wavelengths that differ from each other (e.g., long time averages of green light, red light, and infrared light or red/(or) infrared light, respectively) A weighted average (a value obtained by synchronously weighting and averaging a plurality of wavelength signals) of the signal intensity (long-term average, time average) (described later) may also be used. The ensemble averaging may be refined by finding and removing outlier beats (beats with timing that deviate from the other measured beats), and finding the outlier beats. and remove by ignoring beats whose correlation to the estimated ensemble mean is weaker than the correlation of other beats to the estimated ensemble mean, or by estimating noise and having strong noise This can be done by giving beats emerging from some regions a weight less than other beats. Noise may also be improved by averaging through longer averaging periods.

In this sense, The health monitoring methods contained in this document are
Either or both of the user's ECG signal and/or the first photoplethysmogram PPG signal and/or a plurality of wavelengths (wavelengths, different wavelengths with the same color, different wavelengths with different colors) are respectively weighted. Determining the timing at which each of the plurality of heartbeats appears from a weighted combination, represented by a time series of ensemble average values for each time for a plurality of signals having a plurality of wavelengths, etc. When,
A first pulse shape template (template, sample, pattern, etc.) representing a first pulse shape (waveform of the pulsatile signal), envelope such as dashed curves 632 and 634 in FIG. 6E. calculating a time-averaged value of the first photoplethysmographic PPG signal to generate a data set;
calculating a time-averaged value of each of two further photoelectric plethysmogram signals, one of the further photoelectric plethysmogram signals being a red light signal; the other photoelectric plethysmogram signal is an infrared light signal;
generating a red light signal ensemble mean value for the red light signal and generating an infrared light signal ensemble mean value for the infrared light signal;
comparing each of the red light signal ensemble mean value and the infrared light signal ensemble mean value with the first pulse shape template or data set;
the ensemble mean value for the red light signal and the ensemble for the infrared light signal to determine a linear gain factor between the two signals, the red light signal and the infrared light signal; a linear regression in comparison with said first pulse shape template or data set, each of said ensemble mean values for red light signals and said first pulse shape template or data set; and a linear regression result between the infrared light signal ensemble mean value and the first pulse shape template or data set);
determining the oxygen saturation of the patient from the linear gain factor;
contains.

In a similar light, the methods of pulse oxygenation (determining pulse oxygenation, pulse oximetry, non-invasive oxygen saturation measurement) contained in this document are:
a) Using green light or combining weighted multiple wavelengths (wavelengths, multiple different wavelengths, multiple lights with different wavelengths, optical components, electromagnetic waves, electromagnetic wave components, signal components, etc.) A step of detecting a plurality of heartbeats (heartbeats, heartbeat timing, heartbeat position) using (a weighted combination);
b) generating one or more of a first pulse shape template or a data set representing the first pulse shape,
green wavelengths, one or more green light wavelengths, different green light wavelengths, different green light wavelengths;
an ensemble average for green light over roughly the same length of time as for either red or infrared light, and for multiple green lights that are all green but have different wavelengths values, ensemble average values for different times with the same green light wavelength, ensemble average values for different frames with the same green light wavelength, multiple green lights averaged synchronously thing),
Ensemble average value for multiple wavelengths (wavelengths, multiple wavelengths different from each other, multiple lights with different wavelengths, electromagnetic waves or signal lights, etc.) over roughly the same length of time as for either red or infrared light (an ensemble average), or using an ensemble average for multiple wavelengths over a length of time significantly longer than the length of time for either red or infrared light ( The ensemble average can be used to obtain the heartbeat waveform, the ensemble average indicating the heartbeat waveform), or
a long time average for a single wavelength of any color, the average of the multiple time series data represented by the signal that exist within a long time interval values, time-averaged values having a longer time interval than the time interval of the longer time-averaged values for red and infrared light used to measure oxygen saturation, time-averaged values, etc.);
c) a red pulse shape (pulse shape represented by a red light signal) template or dataset representing the same pulse shape and an infrared pulse shape represented by an infrared light signal obtaining a pulse wave shape template or data set representing the same pulse wave shape, wherein each of the pulse wave shapes is compared to the first pulse wave shape;
d) determining the degree of correlation (such as a correlation coefficient) between the ensemble average value for red light and the first pulse wave shape template by linear regression, and determining the ensemble average for infrared light by linear regression; determining a correlation (such as a correlation coefficient) between the value and the first pulse wave shape template, wherein the ratio of the correlations (correlations, correlation coefficients, etc.) is then the oxygen It includes what is used as the pulsation component ratio (the AC ratio, AC (pulsation) component ratio between a plurality of signals such as a red light signal and an infrared light signal) for obtaining the degree of saturation.

The pulse shape template or data set is described in this document in that, in some embodiments, the pulse shape template represents a long-term ensemble average for the PPG signal. similar to the reference frame template The difference, however, is that the reference frame templates described elsewhere in this document are designed to determine pulse transit time. , whereas where presently related to a first pulse shape (first pulse shape template) or data set or the like, to determine oxygen saturation The point is that it is designed.

The first method is when green light is used for heartbeat detection, but several other methods are equally useful when ECG signals are used for heartbeat detection. Further, some of the alternatives described above have long-term averages for green light, or red light and infrared light as used for the first pulse wave shape, and red light and A short-term average value for infrared light is used to compare the oxygen saturation to the first pulse wave shape. It may be useful that long-term averages for red and infrared light used for the first pulse waveform shape (or data set) are used for oxygen saturation measurements. is associated with relatively short duration signals for red and infrared light. Because the shape is expected to change more slowly than oxygen saturation, we still use shorter time averages to determine the oxygen saturation fraction (and thus more Long term averages can be used to determine the shape while obtaining fast response times.

It should be noted that green was found to be desirable due to its high signal-to-noise ratio, the pulse signal being stronger than other possible body motion noise. That's what it means. However, other wavelengths can be used in place of green, i.e. green can be replaced by other colors in the spectrum of light, and it should be noted that in terms of signal to noise , that some colors work well and others do not. It should be noted that other colors can be used in the manner described in this document even if they do not have the desired signal-to-noise ratio. Similarly, red and/or infrared wavelengths have been the preferred choice hitherto, indicating that red and/or infrared are the specific oxygen of hemoglobin blood in a test subject. oxygenation, oxygen content, blood oxygen, blood oxygen saturation, etc.) was found to be higher than other lights. Each of the oxygen-rich blood reflects an effective amount of red light (some of which is effective as reflected light) more than the other light, and oxygen Blood that does not contain λ reflects an effective amount of infrared light (the portion that is effective as reflected light) that is greater than other light. It is possible to use other colors of light without red and infrared light at all, but other colors of light may have lower (or higher) effectiveness in some particular applications. do not have. It should also be noted that whenever any particular color of light is described, discrete wavelengths of such definition range, as is understood in the art. It is understood as being inside, and the utility (utility, object of interest, object of interest) may be inside or outside the defined range. Thus, it is understood that colors other than green, red, or infrared may be used, and/or any such color selection (color selection, range of colors available, how to select colors, etc.) is the minimum practical performance for either signal-to-noise ratio and/or reflectiveness to oxygen content or other utilities. may be limited only by the requirement to have (minimal effectiveness).

ECG (electrocardiogram) data or green PPG data (or the like) or red light/(or) infrared long-term average data are taken from two or more photoplethysmographs with different light wavelengths. pulse wave signal, photoelectric plethysmogram) may be recorded in association with time. The plurality of heart beats are detected in an electrocardiogram signal or green PPG signal. The beats make it possible to define one "frame" of plethysmogram data during the time between two beats adjacent to each other. Then, two or more of the frames (such as frames for one signal) are averaged together at each point in time, and It is possible to generate an average frame with the time interval (frame duration average obtained by said averaging) obtained by . Since the plethysmogram is correlated with the heartbeat (correlated, time-correlated, temporally correlated, plethysmogram timing and heartbeat timing match each other), the plethysmogram signal is obtained by the averaging process. reinforced (reinforced, noise-reduced). However, motion artifacts and other noise sources not temporally related to heart beats are also mitigated. Thus, the signal-to-noise ratio of said one average frame is typically higher than the signal-to-noise ratio of individual frames (time series of frames before averaging for the same signal).

After constructing an average frame for each of at least two photoplethysmographs, photoplethysmographs, photoplethysmograms, photoplethysmograms with different optical wavelengths, a linear regression method is applied to the two photoplethysmographs. To estimate the gain (gain, intensity ratio between the signals, gain factor, linear gain factor, etc.) between the two average frame signals, which are synchronous with each other can be used for The gain value may be used to obtain information for obtaining blood oxygen saturation, or to estimate other components present in blood, such as hemoglobin, carbon dioxide, or the like. For the same purpose, this process may be repeated for additional and/or alternative light wavelengths.

Some preferred and/or other methods described herein include the red frame signal (a signal representing intensity variations within a frame of the red light signal) and an infrared frame signal (IR frame signal, a signal representing intensity changes within a frame of the infrared light signal) and/or a green frame signal (a signal representing intensity changes within a frame of the green light signal, a green light signal) ) is present (if/when), the gain between a plurality of specific signals, such as between the red frame signal and the infrared frame signal and/or the green frame signal, the intensity ratio between the signals, gain factor, linear gain factor, etc.). In order to obtain these (gain), first, the two frames (the original red frame and the infrared frame that are synchronized) are averaged together (the gain). averaging). As a result of this, a signal with reduced noise may be obtained. The gain is
A linear regression method is performed on the red frame signal versus the composite value (combined, the combination or average of the red frame signal and the infrared frame signal or another signal, the ensemble average value, etc.), and the infrared frame Performing a linear regression method on the signal pair composite value (combined, combining or averaging the infrared frame signal and the red frame signal or another signal together, the ensemble average value, etc.), and then obtaining the results. obtained by taking the ratio between these two results, the regression coefficient of the red frame signal vs. the composite value and the regression coefficient of the infrared frame signal vs. the composite value, or
A linear regression method is applied to a red frame signal versus a green combined value (combined with green, a combination or an average of the red frame signal and the green frame signal (green PPG signal, green light signal), the ensemble average value, etc.). In addition, infrared frame signal vs. green combined value (combined with green), infrared frame signal and green frame signal (green PPG signal, green light signal) combined or averaged together, the above ensemble average value, etc. ), and then the two resulting values (these two results, the regression coefficient of the red frame signal versus the green composite value, and the regression coefficient of the infrared frame signal versus the green composite value). obtained by taking the ratio between, or
Linear regression was performed on the red frame signal versus the green frame signal (green, green PPG signal, green light signal) and linear regression was performed on the infrared frame signal versus the green frame signal (green, green PPG signal, green light signal). , and then the regression coefficients of these two results, the red frame signal versus the green frame signal (green, green PPG signal, green light signal), and the infrared frame signal versus the green obtained by obtaining the ratio between the regression coefficients of the frame signal (green, green PPG signal, green light signal), or
A linear regression method was performed on the combination of the green frame signal (green, green PPG signal, green light signal) with the red frame signal to convert the green frame signal (green, green PPG signal, green light signal) into the infrared frame signal. The ratio between multiple result values (results, regression coefficients for the former linear regression and regression coefficients for the latter linear regression, etc.) obtained by running a linear regression method on a combined composite of signals. is obtained by using

Another method comprises the steps of selecting a possible gain value and applying that candidate gain value to the average frame signal, the average frame of a signal having a wavelength, two different an average frame signal of one wavelength, one of the red frame signal and the infrared frame signal) and another average frame having another wavelength (an average frame, another average frame, the red frame signal and the infrared determining a residual error (error, deviation, difference between the product of said candidate gain value and said average frame and said another average frame) for the other frame signal). This method may be repeated for as many candidate gain values. According to the simple linear regression (regression model with one explanatory variable), the minimum gain value in the whole area (global) is obtained, but according to this method, the local It is possible to obtain multiple local minima. Therefore, if the minimum value in the whole may indicate the degree of correlation (correlation, correlation coefficient, etc.) due to motion artifact, venous blood movement, or another noise source, The minimum may be ignored, and instead a single local minimum may be chosen.

Yet another method is to determine the pulse shape using ensemble averages calculated over longer time intervals for the red and/or infrared light signals, and then determine the pulse shape by: Fitting (shorter time averaged signals, signals time averaged over a time interval shorter than the time interval for the ensemble average) approximating the signal time-averaged over the interval). Basically, Applicants propose that instead of the green light signal or ECG signal described above, such as a signal time-averaged over a shorter time interval, the red light signal or red A long-term average value for the ambient light signal is used.

As noted above, the wearable devices described herein for use on a patient that implement the above aspects are subject to localized skin movement, e.g., in the chest area. It may be particularly useful for monitoring oxygen saturation in some noisy sites, such as sites with relatively high , to obtain the aforementioned measurements.

One embodiment of the aspects described above is shown in FIGS. 6A-6C. In FIG. 6A, curve A (600) shows the time varying output signal for infrared (IR) reflection from the photodiode of the device and curve B (602). shows the time varying output signal for red light reflection from the photodiode of the device. In some embodiments, the skin is alternately illuminated by red and infrared LEDs, thereby generating multiple signals that are collected by the same photodiode. In FIG. 6B, time synchronized (time synchronized with respect to the plurality of pulse oximetry signals of curves A and B) (i.e., time concordant ECG data (or alternative/additional green light PPG data or long term averages for red light or infrared light signals as previously described), curve C Those indicated at (604) have been added to the graph of FIG. 6A. A plurality of peak values (e.g., peaks 606 and 608) in the electrocardiogram data (or long-term averages for green light PPG data or red or infrared light signals, see above) indicates that the pulse • Can be used to define frames or intervals of oximetry data. Another consecutive frames or intervals are specified by 612 and 614, and further frames can be similarly determined (located). According to this aspect, multiple frames of pulse oximetry data are collected. The dimensions of those multiple frames (magnitude, number of frames, data size of frames) may vary greatly depending on the specific application. In some embodiments, the number of frames collected is in the range of 5 to 25, and in one embodiment the frames are in the range of 8 to 10. is the frame of Typically, frames or intervals of pulse oximetry data contain different numbers of signal samples. That is, the output signals from the sensors can be sampled at a preset rate, such as taking 32 samples per second. The number of samples per frame changes as the length of time that exists between peaks in the ECG signal (or long term average for green light PPG data or red or infrared light signals) changes. In one embodiment, multiple features in the ECG data (or long-term averages for green light PPG data or red or infrared light signals) starting points of a frame. The associated peak in the pulse oximetry data (the peak of the pulse oximetry data that is associated with the electrocardiogram at the same time) is approximately the center of the frame. A mid-point or center point is chosen, after which a preset number of signal samples are recorded for each frame. In this embodiment, preferably the preset number is a large enough number to ensure that the peak of the pulse oximetry signal is approximately mid-frame. selected for Multiple sample values corresponding to multiple time points that exceed the preset value are not used. After the frames of data are collected, averages of the numerical values of the frames at corresponding times are calculated. The ac and dc components of said pulse oximetry data are detected from said multiple averages, and then the ac and dc components are used to calculate relative oxygen saturation by conventional methods. A conventional method is such as the ratio-of-ratios algorithm, an example of which is given in Cypress Semiconductor document No. 001-26779 Rev A (January 18, 2010) is. This basic procedure is outlined in the flow chart of FIG. 6C. The frame size (in terms of number of sample values) is detected (620). The values of a plurality of samples at corresponding times in each frame are summed 622 and then average values (average values) are calculated for each time, wherein the average values are: This in turn provides the AC and DC components of the infrared reflection and red light reflection and/or green light reflection with reduced noise. In some embodiments, multiple values for the AC and DC components can be used to calculate oxygen saturation (626) using conventional algorithms. A plurality of relative values (values dependent on environmental conditions) for oxygen saturation may be obtained, for certain embodiments, by calibrating said plurality of measurements to a plurality of absolute values. (absolute value, numerical value that does not depend on environmental conditions). The calibration can be performed in a controlled environment in which multiple individuals are exposed to different concentrations of oxygen in the air and have their oxygen saturation measured. A plurality of measurements are associated with a corresponding plurality of oxygen levels (oxygen concentration in the atmosphere).

In addition to the above embodiments for comparing long-term averages for electrocardiogram (ECG) signals and/or green light PPG or red light or infrared light signals with a plurality of pulse oximetry signals, such comparisons Several other examples exist within the purview of those of ordinary skill in the art for doing so. For example, to locate the peaks of the AC component of a pulse oximetry signal in the presence of noise, the features of the electrocardiogram signal synchronous with it may be combined with the peak of the pulse oximetry signal. At multiple characteristic times appearing before the value and/or minimum value (a time that is determined by itself due to the nature of pulse oximetry, i.e., characteristic time) and multiple characteristic times appearing after that What exists is the value of pulse oximetry when multiple values of pulse oximetry are averaged over multiple heartbeats (it is not necessary to average all values of the pulse oximetry signal over said multiple heartbeats) It can be used to reliably detect peak values (maximum values) and minimum values. For example, within one interval, the peak of the R wave (R wave, QRS wave) of an electrocardiogram signal characteristically appears x milliseconds before the maximum value of the pulse oximetry signal. and appearing y milliseconds after the minimum value of the pulse oximetry signal, the essential information about the alternating component of the pulse oximetry signal is obtained by a plurality of pulse oximetry signals. It can be obtained by repeated measurements of only two values of the oximetry signal (two values at two times).

In some embodiments, multiple values for infrared reflectance or red light reflectance measured by the photodiode can be used to estimate breathing depth and/or rate. is. In FIG. 6D, curves (630) for multiple values for red or infrared or green light over time are shown. In FIG. 6E, the maxima and minima of curve (630) are indicated by dashed curve (632) and dashed curve (634), respectively. The difference between the maximum value and the minimum value at a time is monotonously related to the depth of breathing of the individual being monitored. Thus, as shown, breathing at time (636) is shallower than breathing at time (638). In some implementations, the relationship between respiratory depth and time can be calculated and monitored in an individual. Over time, the curve of maximum and minimum values (curve 630; A curve 630) consisting of dashed curves 632 and 634 may be evaluated.

Turning from the understanding that the respiratory waveform is derived from the RS amplitude and RR interval of the electrocardiogram, the PPG (PPG, plethysmography, photoplethysmography) and/or Alternatively, it turns out that a pulse oximeter can be used to estimate the respiratory waveform relatively directly. Because the chest expands and contracts during breathing, its chest motion is a wandering baseline artifact on the PPG signal. artifacts with wobbly baselines). Filter out the PPG data (data representing the PPG signal, volume plethysmography data) to focus on the breathing/respiration signal (the signal representing the respiratory waveform). The respiration signal (the signal representing the respiration waveform) may be separated from the other components by removing unnecessary components by . This may be particularly relevant if the PPG (PPG, volume plethysmograph, photoplethysmograph) is worn on the chest.

On the other hand, a chest-worn accelerometer may additionally or alternatively be used to measure respiratory waveforms, particularly when the user is in a supine position. As the chest expands and contracts, its acceleration rises and falls (or vice versa, or depending on the orientation of the device), which can be measured by an accelerometer.

any of the above, photoelectric plethysmographs and/or accelerometers, devices and/or methods separately or in combination with each other and/or electrocardiogram-based as described above; It may also be used in situations where a respiration estimation method with Employing multiple methods may improve accuracy over estimates obtained using a single method (such as estimates of respiratory rate and/or respiratory depth). Respiration rate and respiration depth may then be estimated from the respiration signal using time-domain and/or frequency-domain methods.

In some embodiments, the heartbeat timing (eg, obtained from an electrocardiogram signal) and the PPG signal are combined with the pulse transit time, i. can be used to detect the length of time required to propagate to the site of In that case, the detected value of the pulse wave transit time may be used to detect or estimate the blood pressure value. It should be noted that the heartbeat timing, electrocardiogram signal and/or PPG signal may be generated using any number of other methods, systems or devices, conventional or to be developed in the future, or may be generated by a wearable device, such as the devices otherwise described herein. That is, multiple algorithms for it may be available independently or within the wearable cardiac device.

As disclosed elsewhere in the specification, the PPG signals for several heartbeats, e.g. A plurality of sub-signals associated with each other may be averaged by associating each PPG signal with a corresponding heartbeat. As a result, one PPG frame (PPG signal frame) is generated, and in the one PPG frame, the PPG signal associated with the heartbeat is reinforced (reinforced, noise reduced). ), on the other hand, noise not associated with the heartbeat is reduced. Furthermore, since that one PPG frame is already associated with heartbeat timing, the pulse wave transit time is set to one local maximum (peak) to specify either the beginning or the end of the frame itself. Or it may be estimated by determining the position of occurrence of any of the single minimum values. This means the minimum and/or maximum sample(s), the minimum from a plurality of sample values measured by sampling a signal such as an electrocardiogram signal. and/or a maximum value), or a plurality of samples measured of the signal, such as an electrocardiogram signal, to determine a plurality of points lying intermediate the measured sample values. value). For example, interpolation may be performed using quadratic curve fitting, cubic spline curve fitting, digital filtering interpolation, or many other methods.

The pulse transit time may also be estimated by associating the one PPG frame with a sample signal (a sample signal, a reference signal separate from the PPG frame). By shifting the two signals relative to each other (moving the signals on the time axis), the amount of time shift for the highest degree of correlation may be determined. Given that the one sample signal approximates one expected PPG frame, the time shift quantity with the highest correlation may be used to detect the pulse transit time.

A preferred method or algorithm for those described herein is described herein and illustrated in the drawings of FIGS. 7A, 7B and 7C. First, such a method 710 (including or consisting of portions 710a, 710b and/or 710c) comprises at least one heartbeat (typically an electrocardiogram) signal 712 and at least one Two PPG signals 711 are taken as input signals, for example, as shown in FIG. 7A. The heartbeat timing information/signal 712 is used to generate heartbeat timing information by detecting R-waves or other electrocardiogram features from each heartbeat, and multiple electrocardiogram signals (i.e., multiple locations on the human body). , may be used to obtain a more accurate estimate of the heartbeat timing information. The PPG signal 711 may use a single lightwave or multiple signals derived from multiple lightwaves. By using corresponding heartbeat timing information associated with each PPG signal 711, each PPG signal 711 is segmented into a plurality of "frames", shown as PPG Frame 1, PPG Frame 2 and PPG Frame N in FIG. 7A. , wherein each frame contains one PPG signal having a single wavelength that lasts for the duration of a corresponding one of a plurality of heartbeats. I'm in.

Optionally, but typically also a quality estimate of the PPG signal may be performed. An example of this processing is shown in FIG. 7B as portion 710b. This estimate includes: the degree of variance of the PPG signal; an estimate of the signal-to-noise ratio of the PPG signal; Estimates or other information about the PPG signal quality may be considered. FIG. 7B shows a good example of using accelerometer signal 713 used in combination with PPG signal 711 to generate PPG signal quality value/estimate 714 . This signal quality estimate 714 may then be used in combination with heartbeat timing information 712 to generate gains for each frame, FIG. The gain for PPG frame N is shown, where the gain decreases as the signal quality decreases. To reduce computation time, the signal quality estimate (signal quality estimator) 714 may be omitted and some fixed value may be used as the gain information.

As shown in FIG. 7C, weighted, n-sample moving-average, a weighted n-sample moving-average frame (one frame has n sample values, the frame is a weighted moving-average 715, wherein the PPG signals that are correlated with the heartbeat timing are reinforced, while those that are not correlated with the heartbeat timing are reinforced. The gain information (PPG frame 1 gain, PPG frame 2 gain and PPG frame N gain taken from FIG. , may be used with the frame information (PPG Frame 1, PPG Frame 2 and PPG Frame N quoted from FIG. 7A) (in FIG. 7C combined, multiple signals combined, multiple wavelength signals combined etc.)/manipulation (data processing such as manipulated, weighted, averaged, etc.) is shown as being performed.The samples contained in frame (n) (frame (n), weighted n-point moving average frame) 715 The number of samples (the number n of sample values used to obtain the average frame 715) may be adapted to reduce noise or shorten response time. Frames are additionally weighted by time, so that the contribution of some frames immediately before or after the current time The degree may be increased for some frames that are more distant in time and are potentially less important.This additional temporal weighting may be achieved using IIR or FIR filters. good.

Once the average frame 715 is generated for a moment in time, the pulse transit time 716 may be detected by determining the shift of the current frame signal relative to the current heartbeat. This is simply the sample index, which is the position where the signal (such as a PPG signal) exhibits a minimum (true minimum, etc.) or maximum (true maximum, etc.) point. In order to obtain (index, cue position) 717 and to detect the pulse wave propagation time 716, the sample index 717 may be compared with the boundary position (heartbeat timing) of the current frame. When a more precise result is required, interpolation 716 of the signal (a plurality of sample values measured for a signal, such as a PPG signal) is applied to the minimum value of the signal. may be performed using spline curve fitting or polynomial interpolation in the vicinity of the minimum value (such as the measured value for the minimum point) or the maximum value (such as the measured value for the maximum point), so that the minimum ) or said maximum can be determined with an accuracy higher than that corresponding to the sampling rate. Finally, a comparison 719 of the current frame with a reference frame template may be performed, where the average frame 715 is shifted relative to the reference frame template. . The amount of shift with the highest correlation between average frame 715 and the reference frame template indicates pulse transit time 716 . This reference frame template may be a preset signal, or the preset signal may be adapted by using long-term useful frame averages with known pulse transit times. It may be possible to adapt (form).

It should be noted that multiple methods of this kind are available from a variety of sources, including PPG information and heartbeat timing information, non-exclusively from conventional and/or to-be-developed techniques. source), or the PPG information and heartbeat timing information may be obtained separately, alone or together, and/or , a quality signal representing the signal quality obtained from a wearable device and/or system as further described later in the specification (dispersivity of the PPG signal, signal-to-noise of the PPG signal ratio estimates, PPG signal saturation, data obtained from accelerometers or gyroscopes to detect patient behavior, noise estimates in electrocardiogram or impedance measurements, or other information about the PPG signal quality). may be obtained together with

Some further alternatives are on-site medical care, whether in the doctor's or doctor's office, e.g. ICU/CCU (intensive care unit/coronary care unit) It is possible to have data transmission and/or data interpretation performed using equipment. Thus, the device 100 can be used to perform any of a variety of physiological signals, which may include an electrocardiogram, photoplethysmogram, pulse oximetry (arterial blood oxygen saturation) and/or patient acceleration signals. A device that measures one or more will be worn on the patient's chest and held on the chest with an adhesive as described herein. The device 100 optionally transmits the physiological signals wirelessly or by wire (e.g. USB) to a nearby base station for interpretation and further transmission. do. The wireless transmission may use Bluetooth®, Wi-Fi communication, infrared communication, RFID (radio frequency identification) or another wireless protocol. The device 100 can be powered using wireless induction, batteries or a combination thereof. The device 100 monitors and/or acquires data representative of physiological signals. The acquired data can then be transmitted wirelessly or by wire in real time to the nearby base station. The device 100 can be powered wirelessly by the base station or by a battery so that there are wires between the patient and the station. becomes unnecessary.

Additionally and/or alternatively, patients or wearers can be monitored wirelessly in hospitals with ICUs (intensive care units) or other facilities. In this sense, electrocardiographic signals may be measured on the patient using a small, wireless patch device (device used on the body) described herein. The electrocardiogram signal is then digitized and wirelessly transmitted to a receiver. The receiver restores the received ECG signal to an analog signal such that it approximately represents the amplitude of the original ECG signal. The output signal is then sent to an existing hospital ECG monitor via the standard electrode leads. This allows existing hospital infrastructure to be used to monitor a patient without necessarily connecting the patient to the electrocardiogram monitor with lead wires. It becomes possible. The patient's thoracic impedance may be measured as well, allowing the reconstructed ECG signal to approximately represent the output impedance as well as the amplitude of the ECG signal. This can be used to discover patch devices that are not connected. The output impedance may vary continuously, or the output impedance may be a plurality of discrete values, any of which may be selected and used (e.g., to determine which device is connected). , one low discrete value, and one high discrete value to signal that the patch device has loosened). The output impedance may also be used to signal problems with the wireless communication.

Some other embodiments may include coupling one or more sensors to the infant's forehead. First, a method of obtaining oxygen saturation data by mounting a device on the infant's forehead may be used in the method introduced herein. However, an extension or alternative is to couple multiple oxygen saturation sensors, with appropriate relative positions, and multiple temperature sensors into one forehead-mounted device. may have The combined data obtained in this way (a combination of multiple data from multiple sensors) is used to ascertain whether an infant is at risk of suffocation due to being prone. It is possible.

Thus, some of the alternative combinations described herein can have one or more of the following elements, which elements is 1) a medical grade adhesive (available from many suitable sources) for several days (in some instances, e.g., up to selected to have the ability to remain in close contact with the skin without damaging the skin for 10 days or 2 weeks) and operability with various sensors and 2) a conductive electrode or photosensitive detector, capable of supplying an electrical signal from the skin, or from the optical response of the skin tissue or subcutaneous tissue to light excitation. 3) amplifiers, microprocessors and memories capable of processing and storing said signals, and 4) electronic components among those elements and 5) a flexible circuit that can be placed on the skin site of interest. It is possible to connect the aforementioned elements together in a flexible strip that can be followed.

Examples of physiological parameters that can be monitored, recorded/obtained and/or analyzed can include one or more of the following elements, which are: , the electrocardiogram, the photoresponse characteristics of the skin excited by light to detect such things as blood oxygen saturation, heart rate and related variability characteristics, and physical activity/ and an index representing acceleration. One or more of these elements can be used in monitoring ambulatory outpatients with heart disease over several days of daytime and nighttime, thereby allowing post-examination analysis. recording several days' worth of continuous electrocardiogram signals, along with simultaneously recording oxygen saturation and physical exertion (physical exertion by the patient) index values with the electrocardiogram signals; can be done. Similarly, one or more of these elements can be used in monitoring ambulatory outpatients with pulmonary disease over several days of daytime and nighttime, for the purposes of that monitoring. is to record the oxygen saturation for post-examination analysis, along with recording an index of physical activity simultaneously with the oxygen saturation. Alternatively and/or additionally, one or more of the elements may be an inpatient or other subject, such as a neonate, in a clinic, emergency room, or ICU. can be used to monitor wirelessly (or, in some cases, wired) whether the Detects multiple parameters representing physical exertion (physical exertion by the patient), but rather than storing them, wirelessly sends them to a bedside monitor or central station monitor transmission, thereby freeing the patient from wearing physical wires. In particular, the devices described herein can be worn on a newborn's forehead to monitor respiration and oxygen saturation. In an alternative, the devices described herein can be used to monitor respiration and electrocardiograms of patients suffering from sleep apnea.

Although we now describe exemplary computer systems or computing resources that can be used with the devices described herein, it should be noted that many of the computing systems and resources Alternatives to are available and operable to the extent reasonably foreseeable, whereby the following description is properly intended to avoid departing from both the spirit and scope of the invention. It is intended in no way to limit the computing alternatives that may exist.

Some of the multiple implementations of some of the development efforts described herein have various steps. The various steps may be performed by hardware components or embedded in machine-executable instructions, which may be executed using a general purpose computer or the instructions. A special purpose processor programmed with the software may be used to carry out the various steps described above. Alternatively, the steps can be performed by a combination of hardware, software and/or firmware. Thus, FIG. 4 is an example of a plurality of computing resources, computer system 400, with which some implementations described herein are used. According to this example, a sample such as computer system 400 includes a bus 401, at least one processor 402, at least one communication port 403, main memory 404, and removable storage. It may have media 405 , read only memory (ROM) 406 and mass storage (mass storage device) 407 . A greater or lesser number of these elements may be used in a particular embodiment.

Processor 402 can be any known processor, such as, for example, Intel® Itanium® or Itanium 2® processors, AMD® (trademarks), Inc. Opteron(R) or Athlon MP(R) processors, or multiple product line processors from Motorola(R). Transmission port 403 is any of an RS-232 port, a 10/100 Ethernet port, a Universal Serial Bus (USB) port, or a Gigabit port using copper or fiber for dial-up connection using a modem. It is possible to Transmission port 403 may be a local area network (LAN), wide area network (WAN), or other network to which computer system 400 is connected or configured to be connected. can be selected depending on the network.

Main memory 404 may be random access memory (RAM) or any other dynamic storage device known in the art. ROM 406 may be any static storage device such as a programmable ROM (PROM) chip for storing static information, such as instructions for processor 402 .

Mass storage device 407 may be used to store information and instructions. For example, hard disks such as SCSI drives from the Adaptec family of products, optical disks, disk arrays such as RAID, disks such as RAID drives from the Adaptec family of products. • An array or any other mass storage device can be used.

Bus 401 communicatively connects processor 402 to other memory, storage and transmission blocks. Bus 401 may be a PCI/PCI-X or SCSI-based system bus, depending on the storage device used.

Removable storage medium 405 includes an external hard disk drive, floppy disk drive, IOMEGA Zip Drive, compact disk ROM (CD-ROM), compact disk - Can be any kind of Rewritable (CD-RW), Digital Video Disk ROM (DVD-ROM).

The several parts described above are meant to illustrate some of the types available. The several examples described above in no way limit the scope of the respective inventions, as they are merely illustrative embodiments.

Several embodiments of each of the present inventions relate, among other things, to device, system, method, medium and construction aspects for monitoring and processing cardiac parameters and data. While one or more embodiments of the respective inventions have been described above in detail, it will be appreciated by those skilled in the art that various alternatives, modifications, and equivalents exist without departing from the spirit of the respective inventions. Obvious. Therefore, the foregoing description should not be taken as limiting the scope of the respective inventions, which are defined by the following claims.
The present invention provides the following aspects.
(Aspect 1)
Methods, devices and/or systems described in this document.
(Aspect 2)
A system or device or method that uses a light pipe with one or more light sources or LEDs and a barrier therein for health monitoring.
(Aspect 3)
1. A system or device or method using a light pipe having one or more light sources or LEDs and a barrier therein, wherein said barrier is placed in said one to disperse light in a manner suitable for health monitoring. or including arranging around multiple light sources or LEDs.
(Aspect 4)
A light pipe for health monitoring according to any of aspects 1-3, comprising:
one or more light sources or LEDs and a barrier, each disposed within the light pipe;
and/or one or more optical sensors or photodiodes for health monitoring.
(Aspect 5)
A method, device or system according to any of aspects 1-4, wherein
a light transmissive material having therein at least one of the one or more light sources or LEDs and a barrier;
and/or one or more photosensors or photodiodes disposed within said light transmissive material.
(Aspect 6)
A method, device or system for health monitoring according to any of aspects 1-5, further comprising:
A light transmissive material or light pipe encapsulating either or both of said one or more light sources and said one or more light sensors.
(Aspect 7)
The method, device or system of aspect 6, further comprising:
said light transmissive material or light pipe encapsulating either or both of said one or more light sources and said one or more light sensors;
The encapsulation is substantially free of air gaps between the light transmissive material or light pipe encapsulation and either or both of the one or more light sources and the one or more light sensors. The purpose is to improve the efficiency of light emission to the skin and to capture multiple photons that would otherwise be lost (in the absence of such technology). something that is either or both of and
(Aspect 8)
A method, device or system according to any of aspects 1-7, further comprising:
Including an external barrier (another barrier located outside of said barrier).
(Aspect 9)
The method, device or system of aspect 8, wherein
The outer barrier is used for light collection.
(Mode 10)
A method, device or system according to any of aspects 1-9, wherein
The light pipe is used for measurement of oxygen content (oxygenation).
(Aspect 11)
The method, device or system of aspect 10, further comprising:
emitting light from one or more light sources or LEDs;
blocking the emitted light from traversing the barrier;
receiving reflected light emitted from the one or more light sources or LEDs.
(Aspect 12)
A method, device or system according to aspect 11, further comprising:
transmitting light emitted from the one or more light sources into the skin of a subject;
receiving reflected light from the subject;
measuring oxygenation from the reflected light.
(Aspect 13)
13. The method, device or system of any of aspects 10-12, further comprising:
emitting light onto the user's skin by direct (not through other objects) emission and/or reflection;
collecting light by direct (not through another object) reception and/or reflection;
The reflection is directed away from the barrier or the outer barrier.
(Aspect 14)
A method of measuring oxygen content using a light pipe having one or more light sources or LEDs and a barrier inside.
(Aspect 15)
15. The method, device or system of any of aspects 1-14, comprising:
Using one or more of red light, infrared light (IR) and green light, or using a weighted combination of multiple wavelengths.
(Aspect 16)
16. The method, device or system of any of aspects 1-15, comprising:
that the light-transmitting material is made of epoxy;
Is one barrier made of metal and the other made of metal? Is one barrier made of synthetic resin and the other made of synthetic resin? One barrier is made of metal and the other is made of synthetic resin? or that one barrier is made of synthetic resin and the other barrier is made of metal;
the barrier is either or both opaque and diffusely reflective to the wavelength or wavelengths of light used;
the light transmissive material having a substantially flat surface;
The thin-layer adhesive is adhesively fixed to the surface of the light-transmitting material for adhesively fixing to the skin;
that the thin adhesive has a refractive index close to that of the light-transmitting material;
substantially or completely no air gap between the light transmissive body and one or more of the skin, light source and sensor.
(Aspect 17)
A method for measuring oxygenation comprising:
Using a light pipe with one or more light sources or LEDs and a barrier inside.
(Aspect 18)
18. The method of any one of aspects 1-17, wherein
One or more light sources or LEDs are positioned relatively centrally with respect to one or more photosensors or photodiodes such that of the light emitted from said one or more light sources or LEDs, reflected A method of detecting light.
(Aspect 19)
19. The method of any one of aspects 1-18, wherein
A method in which one or more photosensors or photodiodes are arranged peripherally relative to one or more light sources or LEDs.
(Aspect 20)
20. The method of any one of aspects 1-19, wherein
the two light sources or LEDs being centered relative to the two or more photosensors;
the four light sources or LEDs being centered relative to the two or more photosensors;
four light sources or LEDs are centered relative to the four or more light sensors;
A method wherein a barrier is positioned between said plurality of light sensors and said plurality of light sources or LEDs.
(Aspect 21)
A device for monitoring physiological parameters, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) an electrically conductive conductivity sensor attached to the substrate; b) one or more pulse oximetry sensors attached to the substrate; one or more for one or more wavelengths; and/or a combination consisting of a barrier positioned between said one or more pulse oximetry sensors and said one or more light sources or LEDs.
(Aspect 22)
22. The device of aspect 21, wherein
A device wherein said one or more light sources or LEDs are centered relative to said one or more pulse oximetry sensors.
(Aspect 23)
A device as described in aspect 21 or 22 or comprising any of the methods, devices or systems of aspects 1-20, wherein
The one or more pulse oximetry sensors and/or the one or more light sources or LEDs are focused in a focus or control mode on the capillary bed to reduce local motion artifact effects. A device provided to achieve controlled or localized measurements in a small measurement area.
(Aspect 24)
A method for measuring oxygenation comprising:
A method using one or more centrally located light sources or LEDs.
(Aspect 25)
25. The method of aspect 24, wherein
The one or more centrally located light sources or LEDs are coupled to one or more photosensors or photodiodes to detect reflected light from the light emitted from the one or more light sources or LEDs. centered relative to each other.
(Aspect 26)
26. The method of aspect 24 or 25, wherein
A method wherein one or more photosensors or photodiodes are arranged peripherally relative to said one or more light sources or LEDs.
(Aspect 27)
27. The method of any of aspects 24-26, wherein
A method using red light, infrared light (IR) or green light, or using a weighted combination of multiple wavelengths.
(Aspect 28)
28. The method of any of aspects 24-27, wherein
the two light sources or LEDs being centered relative to the two or more photosensors;
the four light sources or LEDs being centered relative to the two or more photosensors;
wherein the four light sources or LEDs are centered relative to the four or more photosensors.
(Aspect 29)
A device for monitoring physiological parameters, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) a conductive sensor having electrical conductivity attached to the substrate; b) one or more pulse oximetry sensors attached to the substrate and one or more for one or more wavelengths; either or both of a light source or in combination with an LED;
The device wherein said one or more light sources or LEDs are centrally located relative to said one or more pulse oximetry sensors.
(Aspect 30)
29. A device as described in aspect 29 or comprising any of the methods of aspects 24-28, wherein
The one or more pulse oximetry sensors and/or the one or more light sources or LEDs may be configured in a wider area of the capillary bed to reduce local motion artifact effects. , an area magnified from the target area in the case of focus mode).
(Aspect 31)
A device for monitoring a physiological parameter according to any of aspects 24-30, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) an electrically conductive sensor mounted on the substrate, and/or b) circuitry for reducing errors due to ambient light using correlated double sampling. ,
The circuit is
one or more optical sensors;
one or more light sources or LEDs for one or more wavelengths, centered relative to said one or more photosensors;
a first switch and a second switch;
a first capacitor and a second capacitor;
the first capacitor is positioned in series with the photosensor;
The second capacitor is positioned in parallel with the output section,
A device in which the first switch and the second switch are arranged between the output and ground to alternately switch between providing an output and shorting to the ground.
(Aspect 32)
A device, system or method for monitoring a physiological parameter according to any of aspects 1-31, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) an electrically conductive sensor mounted on the substrate, and/or b) circuitry for reducing errors due to ambient light using correlated double sampling. ,
The circuit is
one or more optical sensors;
one or more light sources or LEDs for one or more wavelengths;
a barrier positioned between the one or more photosensors and the one or more light sources or LEDs;
a first switch and a second switch;
a first capacitor and a second capacitor;
the first capacitor is positioned in series with the photosensor;
The second capacitor is positioned in parallel with the output section,
The first switch and the second switch are arranged between the output portion and the ground so as to alternately switch between a state of outputting and a state of short-circuiting to the ground.
(Aspect 33)
33. A device, system or method according to aspect 31 or 32, wherein
The one or more light sources or LEDs are centrally located relative to the one or more photosensors.
(Aspect 34)
A device, system or method according to aspects 31, 32 or 33, further comprising
Containing resistors placed in parallel with other circuit elements.
(Aspect 35)
A device, system or method according to aspects 31, 32, 33 or 34, wherein
the first capacitor is C1, the second capacitor is C2, the first switch is S1, the second switch is S2;
When the light source is turned off, the switch S1 is closed and the switch S2 is opened, a charge proportional to the noise signal representing noise is accumulated in C1, after which the switch S1 is opened and the at a point in time when the voltage of C1 is equal to the voltage of the noise signal,
Next, a light signal representing light is measured, the switch S2 is closed and charge is allowed to flow in series via C1 and C2, after which the switch S2 is opened and C2 the voltage is held until the next measurement cycle is started in which case the whole process is repeated;
If C1 is much larger than C2, then almost all of the voltage (the voltage of the light signal) appears on C2, and the voltage of C2 is the noise-free signal, which is the light signal with the noise removed. (s), while C1 is not much greater than C2, then the voltage on C2 is a combination of the previous value of C2 voltage (p) and the noise-free signal, linearly Something that is (C2*s+C1*p)/(C1+C2).
(Aspect 36)
A device, system or method according to aspect 35, wherein
a filtering effect in which a first-order low-pass IIR discrete-time filter is applied to the optical signal;
If that filtering effect is not desired, before the optical signal is measured each cycle, C2 is discharged to zero voltage on C2 and the optical signal held at C2 is (C2* s)/(C1+C2);
(Aspect 37)
37. The device of any of aspects 31-36, wherein
a transimpedance amplifier that replaces resistor R;
a phototransistor that replaces the photosensor;
a plurality of FETs that replace the first and second switches;
A device arranged after said output section and employing one or more of an additional buffering stage, an amplification stage, a filtering stage and a processing stage.
(Aspect 38)
A method, device or system for measuring oxygen saturation in an individual comprising:
a measuring step of measuring an electrocardiogram signal over a plurality of heart beats;
measuring one or more pulse oximetry signals over multiple heartbeats such that the electrocardiogram signal and the one or more pulse oximetry signals are synchronous with each other over one or more heartbeats;
comparing a portion of the electrocardiogram signal and the one or more pulse oximetry signals that are synchronous with each other over one or more heart beats, whereby the one or more pulse oximetry signals are a comparing step of detecting a constant component and a primary periodic component of each of the signals;
determining oxygen saturation from the stationary component and the main cycle component of the one or more pulse oximetry signals.
(Aspect 39)
A method, device or system according to aspect 38, wherein
The pulse oximetry signal includes a reflective infrared signal and a reflective red light signal.
(Aspect 40)
40. The method of aspect 38 or 39, wherein
The comparison step includes:
defining a plurality of intervals of the pulse oximetry signal based on characteristics of the electrocardiogram signal;
averaging a plurality of numerical values of said pulse oximetry signal over said plurality of intervals.
(Aspect 41)
41. The method of any of aspects 38-40, wherein
The method wherein the stationary component and the dominant periodic component of the pulse oximetry signal are determined from the plurality of average values.
(Aspect 42)
42. The method of any of aspects 38-41, wherein
The electrocardiogram signal has R-wave signals, each of the R-wave signals having a peak value for each heartbeat, and the plurality of intervals are determined by looking at the plurality of peak values of the R-wave signal. how to be
(Aspect 43)
43. The method of any of aspects 38-42, wherein
The method wherein said electrocardiogram signal and said pulse oximetry signal are measured from a chest location of said individual.
(Aspect 44)
44. The device, system or method of any of aspects 1-43, wherein
including a wearable monitoring device to reduce noise in health monitoring;
The wearable monitoring device includes at least one sensor for health monitoring,
The wearable monitoring device includes a composite adhesive,
the composite adhesive includes at least one conductive portion applied adjacent to the at least one sensor;
The wearable monitoring device further measures the at least one sensor for signal effectiveness (effective signal to noise ratio) at which the at least one sensor receives a signal with reduced noise. ) is adapted to improve,
The adaptation portion includes a convex lens.
(Aspect 45)
45. The device of aspect 44, wherein
The convex lens is placed in operative contact with the wearer's or user's skin. A device designed to
(Aspect 46)
46. The device of aspect 44 or 45, wherein
The convex lens is operatively applied to the skin of the wearer or user at a position at or near the wearer's or user's forehead or chest. devices that are designed to be placed in contact with each other (interoperable).
(Aspect 47)
47. The device of any of aspects 44-46, wherein
The device wherein the convex lens is an enclosure.
(Aspect 48)
48. The device of any of aspects 44-47, wherein
The encapsulant being the convex lens encloses the at least one sensor.
(Aspect 49)
49. The device of any of aspects 44-48, wherein
The enclosure serving as the convex lens encloses the at least one sensor, and operatively communicates signals between the sensor and the convex lens with respect to the at least one sensor. interoperable), thereby not allowing air gaps to exist at the interface between the at least one sensor and the enclosure.
(Aspect 50)
50. The device of any of aspects 44-49, further comprising:
A device comprising one or more LEDs, wherein the convex encapsulant encloses the one or more LEDs.
(Aspect 51)
51. The device of any of aspects 44-50, wherein
The convex lens encapsulant encloses the one or more LEDs and operatively energizes at least one of the one or more LEDs with a signal between the LED and the convex lens. so that there is an air gap at the interface between said at least one of said one or more LEDs and said encapsulant devices that do not allow
(Aspect 52)
52. The device of any of aspects 44-51, wherein
The device, wherein the convex lens is one or more of being transparent, colorless, made of silicone, and made of medical grade silicone.
(Aspect 53)
53. The device of any of aspects 44-52, wherein
A device in which the adapted portion is used for pulse oximetry (non-invasive oxygen saturation measurement).
(Aspect 54)
54. The device of any of aspects 44-53, further comprising:
A device including one or more functional features including one or more of EKG (electrocardiogram) measurements, PPG (volume pulse wave) measurements, and wearer acceleration measurements.
(Aspect 55)
55. The device of any of aspects 44-54, further comprising:
A device including one or more functional features including either or both of DRL circuitry and proxy DRL circuitry.
(Aspect 56)
56. The device of any of aspects 44-55, further comprising:
A device comprising electrodes for a DRL circuit or electrodes for a proxy DRL circuit worn on the wearer's chest or on the wearer's forehead.
(Aspect 57)
57. The device of aspect 56, comprising:
Said conforming portion is in contact with the wearer's or user's skin with a recessed contact surface and operative, in a state in which signals can be exchanged between the skin and said conforming portion. devices arranged and configured to remain in contact (interoperable).
(Aspect 58)
58. The device of any of aspects 44-57, wherein
LED light waves emitted from the LEDs do not interfere with traveling through the device to reach the wearer's or user's skin, so as not to impede the LED light waves from entering the wearer's or user's skin. device to do.
(Aspect 59)
59. The device of aspect 58, comprising:
Reflected light from the wearer's or user's skin travels through the device to reach the at least one sensor of the LED lightwave emitted from the LED. A device that does things out of the way.
(Aspect 60)
60. The device of any of aspects 44-59, wherein
Made with medical grade silicone,
The silicone is one of substantially transparent, substantially colorless, substantially soft, substantially low durometer, tacky gel, or A device that has multiple or multiple sheets of high-tack adhesives embedded on both sides of the silicone.
(Aspect 61)
61. The device of aspect 60, comprising:
With the silicone having a double-sided adhesive,
conformance of the lens to one or both of the electronic sensor (the at least one sensor) and the skin;
A device that reduces motion artifacts by limiting movement on the interface between skin, lens and sensor, and/or.
(Aspect 62)
62. The device of aspect 60 or 61, wherein
wherein said lens is specially configured to be captured between layers of a composite adhesive strip of said wearable monitoring device and to have a raised portion;
The ridge has the same size as the rectangular opening in the composite adhesive strip, allowing the lens to protrude slightly from the patient side of the composite adhesive strip. device.
(Aspect 63)
63. The device, system or method of any of aspects 1-62, wherein
having a lens for a health sensor for detecting health;
The lens is configured to operatively contact the skin of the wearer or user. and is configured to realize non-interfering intra-light pipe transmission in which energy waves are transmitted in the light pipe in a non-interfering state (a state in which they do not interfere with other energy waves).
(Aspect 64)
64. A method of generating one or more of a pulse shape template or a dataset representing a pulse shape by using the method, system or device of any of aspects 1-63, comprising:
green light wavelength,
ensemble averages for green light over roughly the same length of time as for either red or infrared light;
Ensemble averages for multiple wavelengths over roughly the same length of time for either red or infrared light, or ensemble averages for multiple wavelengths either red or infrared A method comprising using over a longer time length than for any of the lights.
(Aspect 65)
65. A method of determining pulse oxygenation (non-invasive oxygen saturation measurement) by using the method, system or device of any of aspects 1-64, comprising:
generating one or more of a first pulse shape template or a data set representing the first pulse shape;
The production process is
green light wavelength,
an ensemble average value for green light over approximately the same length of time as for either red or infrared light;
Ensemble average values for multiple wavelengths over a time length that is generally the same as the time length for either red or infrared light, or multiple over a longer time length for either red or infrared light using the ensemble average for the wavelengths of or
using a long time average (time average of the data represented by the waveform) for one wavelength with any color.
(Aspect 66)
66. A method of determining pulse oxygenation (non-invasive oxygen saturation measurement) by using the method, system or device of any of aspects 1-65, comprising:
a) using electrocardiogram (ECG) signals, or using green light wavelengths or different wavelengths, or wavelengths (multiple signals with different wavelengths) combined with weights respectively; A detection step of detecting a plurality of heartbeats (heartbeats, heartbeat timing, heartbeat position) by using an object;
b) generating one or more of the first pulse shape template or the first pulse shape data set, comprising:
green light wavelength,
ensemble averages for green light over roughly the same length of time as for either red or infrared light;
Ensemble averages for multiple wavelengths over roughly the same length of time for either red or infrared light, or ensemble averages for multiple wavelengths either red or infrared using a longer time length than for any of the lights, or
using a long time average (time average of the data represented by the waveform) for one wavelength with any color;
c) acquiring a red pulse shape template or a data set representing the same pulse shape and an infrared pulse shape template or a data set representing the same pulse shape, wherein each of the pulse shapes is one to compare with the first pulse wave shape;
d) linear regression to determine the degree of correlation between the ensemble average value for red light and the first pulse wave shape template, and linear regression to determine the ensemble average value for infrared light and the first pulse wave shape template; A determination step of determining the degree of correlation between the pulse wave shape template, wherein the ratio of the degrees of correlation is then used as the pulsation component ratio (the AC ratio, red light, infrared light, etc.) to determine the oxygen saturation used as the AC (pulsation) component ratio between the lights of .
(Aspect 67)
67. The method of any of aspects 1-66, wherein colors other than green, red and infrared are used.
(Aspect 68)
68. The method of aspect 67, wherein color selection is limited only by the requirement that either signal-to-noise ratio and/or reflectivity to contained oxygen have minimal practical performance.
(Aspect 69)
69. A method of health monitoring by using the method or device of any of aspects 1-68, comprising:
Either or both of the user's ECG signal and/or the first photoplethysmographic PPG signal and/or a weighted combination of multiple wavelengths (multiple signals having multiple different wavelengths), respectively from, determining the timing at which each of the plurality of heartbeats appears;
calculating a time-averaged value of the first photoplethysmogram PPG signal to generate a first pulse shape template or data set representing a first pulse shape;
calculating a time-averaged value of each of two further photoelectric plethysmogram signals in relation to the locations of the plurality of heart beats, one of the two further photoelectric plethwave signals being a red light signal; and the other photoelectric plethysmogram signal is an infrared light signal,
generating a red light signal ensemble mean value for the red light signal and generating an infrared light signal ensemble mean value for the infrared light signal;
comparing each of the red light signal ensemble mean value and the infrared light signal ensemble mean value with the first pulse shape template or data set;
an ensemble mean value for the red light signal and the first pulse shape template or data set to determine a linear gain factor between the two signals, the red light signal and the infrared light signal; and linear regression between the infrared light signal ensemble mean value and the first pulse shape template or data set;
and determining patient oxygen saturation from said linear gain factor.
(Aspect 70)
The first photoplethysmogram PPG signal weights a green light signal, a non-red light signal, a non-infrared light signal and/or a plurality of wavelengths (a plurality of signals having a plurality of wavelengths different from each other), respectively. 70. The method of aspect 69, which is one or more of the following:
(Aspect 71)
71. The method of aspect 69 or 70, wherein said two further photoelectric plethysmogram signals comprise one, some or all of two or more of a green light signal, a red light signal and an infrared light signal.
(Aspect 72)
The first PPG or ECG data is another photoplethysmogram or another two or more photoplethysmograms (photoplethysmograms, photoplethysmogram data, photoplethysmogram signal) with different light wavelengths and recording synchronously with
detecting a plurality of heart beats in the first PPG or ECG data, the plurality of heart beats being photoplethysmogram data during the time between two adjacent heart beats; ), and
averaging two or more of the plurality of frames of the photoelectric volume pulse wave data together at each time, thereby generating one average frame having the acquired time interval, wherein the photoelectric volume The photoplethysmograph signal is enhanced by the averaging because the photoplethysmograph is temporally related to the heartbeat, and motion artifacts not temporally related to the heartbeat are also emphasized by other The noise source is also reduced,
interpreting the signal-to-noise ratio of the single average frame as higher than the signal-to-noise ratio of the individual frames;
using linear regression to estimate the gain between two averaged frames for two signals of the photoelectric plethysmogram;
and estimating one or more of oxygen saturation or other components in the blood, including hemoglobin, carbon dioxide or others, from the gain values. Method.
(Aspect 73)
The steps include using another plurality of lights to estimate one or more of oxygen saturation or other components in blood including hemoglobin, carbon dioxide, or others from the gain values. 73. The method of any of aspects 1-72, wherein the method is repeated for wavelengths.
(Aspect 74)
74. A method of using the method or device of any of aspects 1-73, comprising:
selecting one candidate gain value;
multiplying the candidate gain value by an average frame signal (a signal representing an average frame of a signal having a wavelength);
The residual error (difference between said multiplied value and another average frame) for another average frame signal with another wavelength and whereby the gain between the red frame signal and the IR frame signal is a plurality of: obtained by the process of
Those processes are
generating one or more of a PPG signal having a green or other color, or a long time average of a red/infrared light signal;
one of the green PPG signal or the PPG signal with other colors or the red/infrared light signal long time average to generate two frames; incorporating and reflecting a plurality in the red frame signal and the IR frame signal;
first averaging the two frames together to generate a noise-reduced signal (a signal, red light signal, infrared light signal, etc.);
Linear regression between the red light signal and the combination of the red light signal and the green PPG signal, or the red light signal, the red light signal and the red light signal/infrared light signal long term average a linear regression between (long time average) and a composition of
linear regression between an infrared light signal and a combination of the infrared light signal and the green PPG signal, or an infrared light signal, the infrared light signal and the red light signal/infrared light signal compute a linear regression between the long time average and a composite of
a linear regression between a red light signal and a green PPG signal or a linear regression between a red light signal and a long time average of said red light signal/infrared light signal;
Linear regression between infrared light signal and green PPG signal, or linear regression between infrared light signal and said red light signal/infrared light signal long time average. Calculate and , or
A combination of a green PPG signal or the red light signal/infrared light signal long time average combined with a red light signal and a green PPG signal or the red light signal/infrared light calculating a linear regression between the signal long time average and a composite combined with the infrared light signal;
then obtaining the ratio between the two result values respectively corresponding to each other.
(Aspect 75)
75. A method according to aspect 74, performed for determining the depth and/or rate of breathing.
(Aspect 76)
One or more of ECG data, PPG data, pulse oximeter (non-invasive oximeter) data and/or accelerometer data are used to determine the depth and/or rate of breathing. 76. A method according to aspect 74 or 75.
(Aspect 77)
77. The method of aspect 76, comprising generating a respiratory waveform by using one or more of said ECG data, PPG data, pulse oximeter data and/or accelerometer data.
(Aspect 78)
78. The method of any of aspects 74-77, wherein multiple values for red, infrared or green light that change with time are used.
(Aspect 79)
79. A method according to any of aspects 74-78, comprising measuring infrared, red or green reflected light with a photodiode to estimate the depth and/or rate of breathing.
(Aspect 80)
one or both of the maximum and minimum values of the curve or waveform of the infrared data, the red data or the green data, wherein the difference between said maximum value and said minimum value relates to the depth of breathing of the individual being monitored. and/or that the rate of respiration over time can be estimated from a curve representing a plurality of maxima and a plurality of minima aligned in time. Any method described.
(Aspect 81)
81. The method of any of aspects 74-80 using multiple PPG signals.
(Aspect 82)
82. Aspect 81, comprising generating the plurality of PPG signals when the chest expands and contracts during breathing, wherein the chest motion appears on the plurality of PPG signals as an artifact having a wobbly baseline. described method.
(Aspect 83)
83. A method according to aspect 81 or 82, comprising separating the respiratory signal from other components by filtering data representative of the PPG signal to focus on the respiratory signal.
(Aspect 84)
84. The method according to any one of aspects 81 to 83, wherein the photoelectric plethysmograph is worn on the chest.
(Aspect 85)
85. A device using the method of any of aspects 1-84, wherein for acquiring one or more of the plurality of signals,
A wearable health monitoring device having a substrate, an electrically conductive sensor attached to the substrate and having electrical conductivity, at least one conductive adhesive and at least one non-conductive adhesive. Having a double-sided composite adhesive body,
attaching the double-sided composite adhesive body to the substrate and the conductive sensor;
The at least one conductive adhesive portion is disposed in contact with the conductive sensor in a state that enables signal transmission by electrical conduction;
wherein the at least one conductive adhesive is electrically conductively attached to the subject's skin to conduct signal transmission from the subject to the conductive sensor. Or a device that employs multiple.
(Aspect 86)
Photoplethysmography and/or accelerometer and/or one or more of the methods separately or in combination with each other and/or in combination with electrocardiogram-based respiration estimation methods 86. A method according to any of aspects 74-85, wherein the method is used in the state in which it is used.
(Aspect 87)
87. A method according to any of aspects 74-86, wherein using multiple methods improves the accuracy of the estimates, breathing depth and/or rate estimates, over using a single method.
(Aspect 88)
88. A system using the device of aspect 87, further comprising a computer.
(Aspect 89)
A device using the method according to aspect 87 or 88.
(Aspect 90)
90. The device according to aspect 89, using a wearable health monitoring device.
(Aspect 91)
91. The method of any of aspects 74-90 using software and computer hardware to measure oxygen saturation.

Claims (91)

Methods, devices and/or systems described in this document. A system or device or method that uses a light pipe with one or more light sources or LEDs and a barrier therein for health monitoring. 1. A system or device or method using a light pipe having one or more light sources or LEDs and a barrier therein, wherein said barrier is placed in said one to disperse light in a manner suitable for health monitoring. or including arranging around multiple light sources or LEDs. A light pipe for health monitoring according to any one of claims 1 to 3,
one or more light sources or LEDs and a barrier, each positioned within the light pipe;
and/or one or more light sensors or photodiodes for health monitoring. 5. A method, device or system according to any one of claims 1 to 4,
a light transmissive material having therein at least one of the one or more light sources or LEDs and a barrier;
and/or one or more photosensors or photodiodes disposed within said light transmissive material. A method, device or system for health monitoring according to any of claims 1 to 5, further comprising:
A light transmissive material or light pipe encapsulating either or both of said one or more light sources and said one or more photosensors. 7. The method, device or system of claim 6, further comprising:
said light transmissive material or light pipe encapsulating either or both of said one or more light sources and said one or more light sensors;
The encapsulation is substantially free of air gaps between the light transmissive material or light pipe encapsulation and either or both of the one or more light sources and the one or more light sensors. The purpose is to improve the efficiency of light emission to the skin and to capture multiple photons that would otherwise be lost (in the absence of such technology). that which is in either or both of and 8. A method, device or system according to any of claims 1 to 7, further comprising an external barrier (another barrier located outside said barrier). 9. The method, device or system of claim 8, comprising:
The outer barrier is used for light collection. 10. A method, device or system according to any of claims 1-9, comprising:
The light pipe is used for measurement of oxygen content (oxygenation). 11. The method, device or system of claim 10, further comprising:
emitting light from one or more light sources or LEDs;
blocking the emitted light from traversing the barrier;
receiving reflected light emitted from the one or more light sources or LEDs. 12. The method, device or system of claim 11, further comprising:
transmitting light emitted from the one or more light sources into the skin of a subject;
receiving reflected light from the subject;
measuring oxygenation from the reflected light. 13. A method, device or system according to any of claims 10-12, further comprising:
emitting light onto the user's skin by direct (not through other objects) emission and/or reflection;
collecting light by either or both of direct (not through another object) reception and reflection;
The reflection is directed away from the barrier or the outer barrier. A method of measuring oxygen content using a light pipe having one or more light sources or LEDs and a barrier inside. 15. A method, device or system according to any of claims 1-14, comprising:
Using one or more of red light, infrared light (IR) and green light, or using a weighted combination of multiple wavelengths. 16. A method, device or system according to any of claims 1-15, comprising:
that the light-transmitting material is made of epoxy;
Is one barrier made of metal and the other made of metal? Is one barrier made of synthetic resin and the other made of synthetic resin? One barrier is made of metal and the other is made of synthetic resin? or that one barrier is made of synthetic resin and the other barrier is made of metal;
the barrier is either or both opaque and diffusely reflective to the wavelength or wavelengths of light used;
the light transmissive material having a substantially flat surface;
The thin-layer adhesive is adhesively fixed to the surface of the light-transmitting material for adhesively fixing to the skin;
that the thin adhesive has a refractive index close to that of the light-transmitting material;
substantially or completely no air gap between the light transmissive body and one or more of the skin, light source and sensor. A method for measuring oxygenation comprising:
Using a light pipe with one or more light sources or LEDs and a barrier inside. 18. A method according to any one of claims 1 to 17,
One or more light sources or LEDs are positioned relatively centrally with respect to one or more photosensors or photodiodes such that of the light emitted from said one or more light sources or LEDs, reflected A method of detecting light. 19. A method according to any one of claims 1 to 18,
A method in which one or more photosensors or photodiodes are arranged peripherally relative to one or more light sources or LEDs. 20. A method according to any one of claims 1 to 19,
the two light sources or LEDs being centered relative to the two or more photosensors;
the four light sources or LEDs being centered relative to the two or more photosensors;
four light sources or LEDs are centered relative to the four or more light sensors;
A method wherein a barrier is positioned between said plurality of light sensors and said plurality of light sources or LEDs. A device for monitoring physiological parameters, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) an electrically conductive conductivity sensor attached to the substrate; b) one or more pulse oximetry sensors attached to the substrate; one or more for one or more wavelengths; and/or a combination consisting of a barrier positioned between said one or more pulse oximetry sensors and said one or more light sources or LEDs. 22. The device of claim 21, wherein
A device wherein said one or more light sources or LEDs are centered relative to said one or more pulse oximetry sensors. A device as recited in claim 21 or 22 or comprising any of the methods, devices or systems of claims 1 to 20, comprising:
The one or more pulse oximetry sensors and/or the one or more light sources or LEDs are focused in a focus or control mode on the capillary bed to reduce local motion artifact effects. A device provided to achieve controlled or localized measurements in a small measurement area. A method for measuring oxygenation comprising:
A method using one or more centrally located light sources or LEDs. 25. The method of claim 24, wherein
The one or more centrally located light sources or LEDs are coupled to one or more photosensors or photodiodes to detect reflected light from the light emitted from the one or more light sources or LEDs. centered relative to each other. 26. The method of claim 24 or 25, wherein
One or more photosensors or photodiodes detect the one or more light sources or L
A method that is positioned peripherally (outward) relative to the ED. 27. The method of any of claims 24-26,
A method using red light, infrared light (IR) or green light, or using a weighted combination of multiple wavelengths. 28. The method of any of claims 24-27,
the two light sources or LEDs being centered relative to the two or more photosensors;
the four light sources or LEDs being centered relative to the two or more photosensors;
four light sources or LEDs are centered relative to the four or more photosensors. A device for monitoring physiological parameters, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) a conductive sensor having electrical conductivity attached to the substrate; b) one or more pulse oximetry sensors attached to the substrate and one or more for one or more wavelengths; either or both of a light source or in combination with an LED;
The device wherein said one or more light sources or LEDs are centrally located relative to said one or more pulse oximetry sensors. A device as recited in claim 29 or comprising any of the methods of claims 24-28,
The one or more pulse oximetry sensors and/or the one or more light sources or LEDs may be configured in a wider area of the capillary bed to reduce local motion artifact effects. , an area magnified from the target area in the case of focus mode). A device for monitoring physiological parameters according to any of claims 24-30,
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) an electrically conductive sensor mounted on the substrate, and/or b) circuitry for reducing errors due to ambient light using correlated double sampling. ,
The circuit is
one or more optical sensors;
one or more light sources or LEDs for one or more wavelengths, centered relative to said one or more photosensors;
a first switch and a second switch;
a first capacitor and a second capacitor;
the first capacitor is positioned in series with the photosensor;
The second capacitor is positioned in parallel with the output section,
A device in which the first switch and the second switch are arranged between the output and ground to alternately switch between providing an output and shorting to the ground. 32. A device, system or method for monitoring physiological parameters according to any of claims 1-31, comprising:
the device is configured to be adhesively secured to a subject's skin for monitoring the physiological parameter;
The device is
a substrate;
a) a conductive sensor mounted to the substrate and having electrical conductivity; and b) circuitry for reducing errors due to ambient light using correlated double sampling. ,
The circuit is
one or more optical sensors;
one or more light sources or LEDs for one or more wavelengths;
a barrier positioned between the one or more photosensors and the one or more light sources or LEDs;
a first switch and a second switch;
a first capacitor and a second capacitor;
the first capacitor is positioned in series with the photosensor;
The second capacitor is positioned in parallel with the output section,
The first switch and the second switch are arranged between the output section and the ground so as to alternately switch between an output state and a ground short-circuit state. 33. A device, system or method according to claim 31 or 32, comprising
The one or more light sources or LEDs are centrally located relative to the one or more photosensors. 34. The device, system or method of claim 31, 32 or 33, further comprising a resistor positioned in parallel with other circuit elements. 35. A device, system or method according to claim 31, 32, 33 or 34, wherein
the first capacitor is C1, the second capacitor is C2, the first switch is S1, the second switch is S2;
When the light source is turned off, the switch S1 is closed and the switch S2 is opened, a charge proportional to the noise signal representing noise is accumulated in C1, after which the switch S1 is opened and the at the moment the voltage of C1 is equal to the voltage of the noise signal,
Next, a light signal representing light is measured, the switch S2 is closed and charge is allowed to flow in series via C1 and C2, after which the switch S2 is opened and C2 the voltage is held until the next measurement cycle is started in which case the whole process is repeated;
If C1 is much larger than C2, then almost all of the voltage (the voltage of the light signal) appears on C2, and the voltage of C2 is the noise-free signal, which is the light signal with the noise removed. (s), while C1 is not much greater than C2, then the voltage on C2 is a combination of the previous value of C2 voltage (p) and the noise-free signal, linearly Something that is (C2*s+C1*p)/(C1+C2). 36. A device, system or method according to claim 35, comprising:
a filtering effect in which a first-order low-pass IIR discrete-time filter is applied to the optical signal;
If that filtering effect is not desired, before the optical signal is measured each cycle, C2 is discharged to zero voltage on C2 and the optical signal held at C2 is (C2* s)/(C1+C2); 37. A device according to any of claims 31-36, wherein
a transimpedance amplifier that replaces resistor R;
a phototransistor that replaces the photosensor;
a plurality of FETs that replace the first and second switches;
A device arranged after said output section and employing one or more of an additional buffering stage, an amplification stage, a filtering stage and a processing stage. A method, device or system for measuring oxygen saturation in an individual comprising:
a measuring step of measuring an electrocardiogram signal over a plurality of heart beats;
measuring one or more pulse oximetry signals over multiple heartbeats such that the electrocardiogram signal and the one or more pulse oximetry signals are synchronous with each other over one or more heartbeats;
comparing a portion of the electrocardiogram signal and the one or more pulse oximetry signals that are synchronous with each other over one or more heart beats, whereby the one or more pulse oximetry signals are a comparing step of detecting a constant component and a primary periodic component of each of the signals;
determining oxygen saturation from the stationary component and the main cycle component of the one or more pulse oximetry signals. 39. The method, device or system of claim 38, comprising:
The pulse oximetry signal includes a reflective infrared signal and a reflective red light signal. 40. The method of claim 38 or 39, wherein
The comparison step includes:
defining a plurality of intervals of the pulse oximetry signal based on characteristics of the electrocardiogram signal;
averaging a plurality of numerical values of said pulse oximetry signal over said plurality of intervals. 41. The method of any of claims 38-40,
The method wherein the stationary component and the dominant periodic component of the pulse oximetry signal are determined from the plurality of average values. 42. The method of any of claims 38-41, wherein
The electrocardiogram signal comprises an R-wave signal, each of which has a peak value for each heart beat, and the plurality of intervals are determined by looking at the plurality of peak values of the R-wave signal. how to be 43. The method of any of claims 38-42, wherein
The method wherein said electrocardiogram signal and said pulse oximetry signal are measured from a chest location of said individual. 44. A device, system or method according to any of claims 1-43, wherein
including a wearable monitoring device to reduce noise in health monitoring;
The wearable monitoring device includes at least one sensor for health monitoring,
The wearable monitoring device includes a composite adhesive,
the composite adhesive includes at least one conductive portion applied adjacent to the at least one sensor;
The wearable monitoring device further measures the at least one sensor for signal effectiveness (effective signal to noise ratio) at which the at least one sensor receives a signal with reduced noise. ) is adapted to improve,
The adaptation portion includes a convex lens. 45. The device of claim 44, comprising:
The convex lens is placed in operative contact with the wearer's or user's skin. A device designed to 46. The device of claim 44 or 45, wherein
The convex lens is operatively applied to the skin of the wearer or user at a position at or near the wearer's or user's forehead or chest. devices that are designed to be placed in contact with each other (interoperable). 47. The device of any of claims 44-46, wherein
The device wherein the convex lens is an enclosure. 48. The device of any of claims 44-47, wherein
The encapsulant being the convex lens encloses the at least one sensor. 49. A device according to any of claims 44-48,
The enclosure serving as the convex lens encloses the at least one sensor, and operatively communicates signals between the sensor and the convex lens with respect to the at least one sensor. interoperable), thereby not allowing an air gap to exist at the interface between the at least one sensor and the enclosure. 50. The device of any of claims 44-49, further comprising:
A device comprising one or more LEDs, wherein the convex encapsulant encloses the one or more LEDs. 51. A device according to any of claims 44-50,
The convex lens encapsulant encloses the one or more LEDs and operatively energizes at least one of the one or more LEDs with a signal between the LED and the convex lens. interoperable) such that there is an air gap at the interface between said at least one of said one or more LEDs and said encapsulant devices that do not allow 52. A device according to any of claims 44-51, wherein
The device, wherein the convex lens is one or more of being transparent, colorless, made of silicone, and made of medical grade silicone. 53. The device of any of claims 44-52, wherein
A device in which the adapted portion is used for pulse oximetry (non-invasive oxygen saturation measurement). 54. The device of any of claims 44-53, further comprising:
A device including one or more functional features including one or more of EKG (electrocardiogram) measurements, PPG (volume pulse wave) measurements, and wearer acceleration measurements. 55. The device of any of claims 44-54, further comprising:
A device including one or more functional features including either or both of DRL circuitry and proxy DRL circuitry. 56. The device of any of claims 44-55, further comprising:
A device comprising electrodes for a DRL circuit or electrodes for a proxy DRL circuit worn on the wearer's chest or on the wearer's forehead. 57. The device of claim 56, comprising:
Said conforming portion is in contact with the wearer's or user's skin with a recessed contact surface and operative, in a state in which signals can be exchanged between the skin and said conforming portion. devices arranged and configured to remain in contact (interoperably). 58. A device according to any of claims 44-57,
LED light waves emitted from the LEDs do not interfere with traveling through the device to reach the wearer's or user's skin, so as not to impede the LED light waves from entering the wearer's or user's skin. device to do. 59. The device of claim 58, comprising:
Reflected light from the wearer's or user's skin travels through the device to reach the at least one sensor of the LED lightwave emitted from the LED. A device that does things out of the way. 60. A device according to any of claims 44-59,
Made with medical grade silicone,
The silicone is one of substantially transparent, substantially colorless, substantially soft, substantially low durometer, tacky gel, or A device having multiple or multiple sheets of high-tack adhesives embedded on both sides of the silicone. 61. The device of claim 60, comprising:
With the silicone having a double-sided adhesive,
conformance of the lens to one or both of the electronic sensor (the at least one sensor) and the skin;
A device that reduces motion artifacts by limiting movement on the interface between skin, lens and sensor, and/or. 62. A device according to claim 60 or 61, wherein
wherein said lens is specially configured to be captured between layers of a composite adhesive strip of said wearable monitoring device and to have a raised portion;
The ridge has the same size as the rectangular opening in the composite adhesive strip, allowing the lens to protrude slightly from the patient side of the composite adhesive strip. device. 63. A device, system or method according to any of claims 1-62, comprising:
having a lens for a health sensor for detecting health;
The lens is configured to operatively contact the skin of the wearer or user. and is configured to realize non-interfering intra-light pipe transmission in which energy waves are transmitted in the light pipe in a non-interfering state (a state in which they do not interfere with other energy waves). 64. A method of generating one or more of a pulse shape template or a dataset representing a pulse wave shape by using the method, system or device of any of claims 1-63, comprising:
green light wavelength,
ensemble averages for green light over roughly the same length of time as for either red or infrared light;
Ensemble averages for multiple wavelengths over roughly the same length of time for either red or infrared light, or ensemble averages for multiple wavelengths either red or infrared A method comprising using over a time length longer than the time length for either of the lights. 65. A method of determining pulse oxygenation (non-invasive oxygen saturation measurement) by using a method, system or device according to any one of claims 1 to 64, comprising:
generating one or more of a first pulse shape template or a data set representing the first pulse shape;
The production process is
green light wavelength,
an ensemble average value for green light over approximately the same length of time as for either red or infrared light;
Ensemble average values for multiple wavelengths over a time length that is generally the same as the time length for either red or infrared light, or multiple over a longer time length for either red or infrared light using the ensemble average for the wavelengths of or
using a long time average (time average of the data represented by the waveform) for one wavelength with any color. 66. A method of determining pulse oxygenation (non-invasive oxygen saturation measurement) by using a method, system or device according to any one of claims 1 to 65, comprising:
a) using electrocardiogram (ECG) signals, or using green light wavelengths or different wavelengths, or wavelengths (multiple signals with different wavelengths) combined with weights respectively; A detection step of detecting a plurality of heartbeats (heartbeats, heartbeat timing, heartbeat position) by using an object;
b) generating one or more of the first pulse shape template or the first pulse shape data set, comprising:
green light wavelength,
ensemble averages for green light over roughly the same length of time as for either red or infrared light;
Ensemble averages for multiple wavelengths over roughly the same length of time for either red or infrared light, or ensemble averages for multiple wavelengths either red or infrared using a longer time length than for any of the lights, or
using a long time average (time average of the data represented by the waveform) for one wavelength with any color;
c) acquiring a red pulse shape template or a data set representing the same pulse shape and an infrared pulse shape template or a data set representing the same pulse shape, wherein each of the pulse shapes is one to compare with the first pulse wave shape;
d) linear regression to determine the degree of correlation between the ensemble average value for red light and the first pulse wave shape template, and linear regression to determine the ensemble average value for infrared light and the first pulse wave shape template; A determination step of determining the degree of correlation between the pulse wave shape template, wherein the ratio of the degrees of correlation is then used as the pulsation component ratio (the AC ratio, red light, infrared light, etc.) to determine the oxygen saturation used as the AC (pulsation) component ratio between the lights of . 67. A method according to any preceding claim, wherein colors other than green, red and infrared are used. 68. The method of claim 67, wherein color selection is limited only by the requirement that either signal-to-noise ratio and/or reflectivity to contained oxygen have minimum practical performance. 69. A method of health monitoring by using the method or device of any of claims 1-68, comprising:
Either or both of the user's ECG signal and/or the first photoplethysmographic PPG signal and/or a weighted combination of multiple wavelengths (multiple signals having multiple different wavelengths), respectively from, determining the timing at which each of the plurality of heartbeats appears;
calculating a time-averaged value of the first photoplethysmogram PPG signal to generate a first pulse shape template or data set representing a first pulse shape;
calculating a time-averaged value of each of two further photoelectric plethysmogram signals in relation to the locations of the plurality of heart beats, one of the two further photoelectric plethwave signals being a red light signal; and the other photoelectric plethysmogram signal is an infrared light signal,
generating a red light signal ensemble mean value for the red light signal and generating an infrared light signal ensemble mean value for the infrared light signal;
comparing each of the red light signal ensemble mean value and the infrared light signal ensemble mean value with the first pulse shape template or data set;
an ensemble mean value for the red light signal and the first pulse shape template or data set to determine a linear gain factor between the two signals, the red light signal and the infrared light signal; and linear regression between the infrared light signal ensemble mean value and the first pulse shape template or data set;
and determining patient oxygen saturation from said linear gain factor. The first photoplethysmogram PPG signal weights a green light signal, a non-red light signal, a non-infrared light signal and/or a plurality of wavelengths (a plurality of signals having a plurality of wavelengths different from each other), respectively. 70. The method of claim 69, which is one or more of the following: 71. A method according to claim 69 or 70, wherein said two further photoelectric plethysmogram signals comprise one, some or all of two or more of a green light signal, a red light signal and an infrared light signal. The first PPG or ECG data is another photoplethysmogram or another two or more photoplethysmograms (photoplethysmograms, photoplethysmograms, photoplethysmograms, photoplethysmograms) and different light wavelengths and recording synchronously with
detecting a plurality of heart beats in the first PPG or ECG data, the plurality of heart beats being photoplethysmogram data during the time between two adjacent heart beats; ), and
averaging two or more of the plurality of frames of the photoelectric volumetric pulse wave data collectively at each time, thereby generating one average frame having the acquired time interval, wherein the photoelectric volume The photoplethysmograph signal is enhanced by the averaging because the photoplethysmograph is temporally related to the heartbeat, and motion artifacts not temporally related to the heartbeat are also emphasized by other The noise source is also reduced,
interpreting the signal-to-noise ratio of the single average frame as higher than the signal-to-noise ratio of the individual frames;
using linear regression to estimate the gain between two averaged frames for two signals for the photoelectric plethysmogram;
estimating from the gain value one or more of oxygen saturation or other components in the blood including hemoglobin, carbon dioxide or others. the method of. The steps include using another plurality of lights to estimate one or more of oxygen saturation or other components in blood including hemoglobin, carbon dioxide, or others from the gain values. 73. A method according to any preceding claim, wherein the method is repeated for wavelengths. 74. A method of using the method or device of any of claims 1-73, comprising:
selecting one candidate gain value;
multiplying the candidate gain value by an average frame signal (a signal representing an average frame of a signal having a wavelength);
The residual error (difference between said multiplied value and another average frame) for another average frame signal with another wavelength and whereby the gain between the red frame signal and the IR frame signal is a plurality of: obtained by the process of
Those processes are
generating one or more of a PPG signal having a green or other color, or a long time average of a red/infrared light signal;
one of the green PPG signal or the PPG signal with other colors or the red/infrared light signal long time average to generate two frames; incorporating and reflecting a plurality in the red frame signal and the IR frame signal;
first averaging the two frames together to generate a noise-reduced signal (a signal, red light signal, infrared light signal, etc.);
Linear regression between the red light signal and the combination of the red light signal and the green PPG signal, or the red light signal, the red light signal and the red light signal/infrared light signal long term average a linear regression between (long time average) and a composition of
linear regression between an infrared light signal and a combination of the infrared light signal and the green PPG signal, or an infrared light signal, the infrared light signal and the red light signal/infrared light signal compute a linear regression between the long time average and a composite of
a linear regression between a red light signal and a green PPG signal or a linear regression between a red light signal and a long time average of said red light signal/infrared light signal;
Linear regression between infrared light signal and green PPG signal, or linear regression between infrared light signal and said red light signal/infrared light signal long time average. Calculate and , or
a combination of a green PPG signal or said red light signal/infrared light signal long time average with a red light signal and a green PPG signal or said red light signal/infrared light signal; calculating a linear regression between the signal long time average and a composite combined with the infrared light signal;
then obtaining the ratio between the two result values respectively corresponding to each other. 75. The method of claim 74, performed to determine the depth and/or rate of breathing. One or more of ECG data, PPG data, pulse oximeter (non-invasive oximeter) data and/or accelerometer data are used to determine the depth and/or rate of breathing. 76. A method according to claim 74 or 75. 77. The method of claim 76, comprising generating a respiratory waveform by using one or more of said ECG data, PPG data, pulse oximeter data and/or accelerometer data. 78. A method according to any one of claims 74 to 77, wherein multiple values for red, infrared or green light that change with time are used. 79. A method according to any one of claims 74 to 78, comprising measuring infrared reflected light, red reflected light or green reflected light with a photodiode to estimate the depth and/or rate of breathing. one or both of the maximum and minimum values of the curve or waveform of the infrared data, the red data or the green data, wherein the difference between said maximum value and said minimum value relates to the depth of breathing of the individual being monitored. and/or over time the rate of breathing can be estimated from a curve representing a plurality of maxima and a plurality of minima aligned in time. The method according to any one of 81. A method according to any of claims 74-80, wherein multiple PPG signals are used. 81. Generating said plurality of PPG signals when a chest expands and contracts during breathing, said chest motion appearing on said plurality of PPG signals as an artifact having a wobbly baseline. The method described in . 83. A method according to claim 81 or 82, comprising separating the respiratory signal from other components by filtering data representative of the PPG signal to focus on the respiratory signal. 84. A method according to any one of claims 81 to 83, wherein the photoelectric plethysmograph is worn on the chest. 85. A device using the method of any of claims 1-84, comprising:
A wearable health monitoring device having a substrate, an electrically conductive sensor attached to the substrate and having electrical conductivity, at least one conductive adhesive and at least one non-conductive adhesive. Having a double-sided composite adhesive body,
attaching the double-sided composite adhesive body to the substrate and the conductive sensor;
The at least one conductive adhesive portion is disposed in contact with the conductive sensor in a state that enables signal transmission by electrical conduction;
wherein the at least one conductive adhesive is electrically conductively attached to the subject's skin to conduct signal transmission from the subject to the conductive sensor. Or a device that employs multiple. Photoplethysmography and/or accelerometer and/or one or more of the methods separately or in combination with each other and/or in combination with electrocardiogram-based respiration estimation methods 86. A method according to any one of claims 74 to 85, used in a closed state. 87. A method according to any one of claims 74 to 86, wherein using multiple methods improves the accuracy of the estimates, breathing depth and/or rate estimates, over using a single method. . 88. A system using the device of claim 87, further comprising a computer. 89. A device using the method of claim 87 or 88. 90. The device of Claim 89, wherein the device employs a wearable health monitoring device. 91. The method of any of claims 74-90, using software and computer hardware to measure oxygen saturation.

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