JP2020513876A - System and method for monitoring health status - Google Patents

Abstract

System, method and device for reducing noise in health monitoring, wherein the monitoring receives a health signal for health monitoring and/or has at least one electrode or sensor for health monitoring. What is a system, method and device for. [Selection diagram] Figure 1A

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 use in a wide range of health monitoring devices. However, some improvements may still be desired for health monitoring devices and systems that enable effective collection of data and / or detection of parameters. One or more of the manipulations for parameter determination are provided.

  And multiple options for patients and their physicians (alternatives, alternatives to previous ones, multiple alternatives, multiple alternatives, multiple alternatives) are robust. (Robust, robust, disturbance tolerant, structurally stable) and may be developed to include a number of convenient monitors, which in some cases ( (instances), acquire (collect, collect) and transmit (collect, collect) short-term data (short-term data, useful data for short periods, etc.) or long-term data (long-term data, useful data for long periods, etc.) transfer and / or monitoring of multiple events in real time, and the multiple monitors may, in some cases, be multivariate. May include a step of detecting (determination, determination, identification, estimation) of various parameters (multi-variable parameter, multivariate parameter, multivariable parameter, one parameter having plural variables, plural parameters as plural variables) Absent.

  Described in this document are multiple-choice (alternative, alternative, new, interchangeable, alternatives) medical monitoring devices, systems and / or methods. For use in parameter determination, the device, system and / or method, in some cases, being one or more individuals. , For example, neonates, infants, children, infants, mothers / or parents, athletes or patients such as cardiac and / or respiratory data and / or temperature (temperature, It is intended for long-term sensing and / or recording of body temperature data. A number of alternative and alternative embodiments and applications are outlined in this document, below, and throughout this specification and / or It is illustrated.

  In another aspect, the results of the development of some of the ones described in this document include an embodiment, in which a health device. , One or more individual (one or more individuals, individual, patient) one or more physiological parameters (physiological parameters, parameters describing the physiological activity or physiological event of the patient, multiple physiological parameters) One or more sensors are configured to monitor from multiple measurements taken by the one or more sensors that are in sync with each other (time-concordant, the measurement times coincide with each other), wherein the one or more sensors are electrocardiograms. one or more electrodes for measuring ionic potential changes (electrocardiogram) (ECG) and / or for measuring optically based oxygen saturation One or more light sources and one or more photodetectors, in some cases including LED and photodiode pairs, and / or Or one or more temperature sensors, and / or movement and exercise, the physical load or force used by the patient that causes the movement, (One or more xyz accelerometers, instruments for measuring acceleration in the directions of x-axis, y-axis and z-axis, 3-axis accelerometers, accelerometers) for measuring motility, exertion) , And the like, or various variations consisting of one or more of them in a non-exclusive manner. In some embodiments, the methods and devices that are the result of some of the developments described in this document may be used to generate a respiration waveform. Some other embodiments embody a circuit that mimics a DRL circuit (driven right-leg circuit, right leg drive circuit, right leg drive circuit, right leg driven circuit, right leg drive circuit) (in this document). Is sometimes referred to as "a proxy DRL circuit (proxy driven right-leg circuit, proxy DRL circuit, pseudo right leg drive circuit) that realizes the same function as the original DRL circuit)," Conveniently, as common mode noise, common mode noise, or noise generated in a small-footprint device that is worn by an individual or has the ability to be worn by an individual. May have a reduced in-phase signal).

  In yet an alternative aspect of what is described in this document, the blood pressure detection value (a blood pressure determination value) is, in some cases, a pulse transit time (pulse transit time). Wave propagation velocity, pulse propagation time) may be generated. The pulse wave transit time is the time required for the cardiac pressure wave to propagate from the heart to other parts of the human body. The pulse wave transit time measurements may then be used to estimate blood pressure values. A signal representing the heart beat timing from the electrocardiogram or something else and a signal representing the volumetric photoplethysmogram (also known as PPG), It can be used to generate pulse wave transit times. It should be noted that signals such as these may be generated from conventional or other processes and / or devices or systems to be developed in the future, or signals such as these. Signal may be obtained from one or more wearable health monitoring devices, such as also described later in this document.

  In another alternative aspect, the results of the development of what is described in this document are, in some cases, pulse oximetry (pulse oximetry) signals (pulse oximetry). signals, signals representing arterial oxygen saturation, multiple pulse oximetry signals) and electrocardiogram signals (ECG signals, multiple electrocardiogram signals) that are synchronized with each other (time-concordant). There may be one or more methods and / or devices for measuring and / or determining parameters (oxygen saturation parameters). In some embodiments, the ECG signals are a plurality of intervals of the pulse oximetry data (interval, time intervals, time intervals, intervals), i.e. frame, a repeating unit of a waveform), the plurality of time intervals or frames are the main periodic component of the pulse oximetry signal. , The strongest of the plurality of periodic components, the primary periodic component) (eg, DC and AC components) are collected and averaged (averaged, eg, , Multiple frames are averaged, phase by phase, and from their stationary and main periodic components, some number of oxygen saturation is now detected (determined, detected) )Is possible. A patient wearable device for some embodiments of this type comprises a pulse oximetry and ECG (ECG, electrocardiogram) sensor, the device comprising: It may be particularly useful when placed on the chest of a patient to obtain such a signal.

  Some other alternatives and / or additions that can be added to others. Similar to the aspects described above, some of the aspects described above are illustrated as being illustrated with a number of alternative and / or additional embodiments and applications. Some of these are illustrated in the accompanying drawings and are described in the claims that follow regarding their features. However, as will be appreciated by one of skill in the art, the above summary of the invention and the modes for carrying out the invention described below do not fully describe the overall scope of the invention, and of course, the present invention. It is not intended to describe each illustrated embodiment of the invention, nor to describe all possible implementations of the invention, but also to protect the multiple claims set forth below in this document. No limitation is imposed on the range.

  The accompanying drawings include the following drawings.

FIG. 1 has and is constituted by several sub-figures of FIGS. 1A-1R, which show several alternatives to the development efforts described in this document. , Multiple alternatives), and this FIG. 1 shows multiple devices and multiple conductive adhesives that are alternative (selectable). It has various perspective, top, bottom and side views of the structure. 1B and 1C are diagrams showing a device. FIG. 1D is a diagram showing a device. 1E and 1F are diagrams showing the device. FIG. 1G is a diagram showing a device. FIG. 1H is a diagram showing a device. 1I and 1J are diagrams showing the device. FIG. 1K is a diagram showing a device. FIG. 1L is a diagram showing a device. FIG. 1M is a diagram showing a device. FIG. 1N is a diagram illustrating a device. FIG. 10 is a diagram showing a device. FIG. 1P is a diagram showing a device. FIG. 1Q is a diagram showing a device. FIG. 1R is a diagram showing a device.

FIG. 2 has and is constructed by FIGS. 2A-2D as a plurality of sub-figures, which FIG. 2 illustrates several alternative DRL circuit alternative circuits. The figures are shown in FIGS. 2A-2C, and in FIG. 2D, a circuit diagram of pulse oximetry is shown. 2B and 2C are partial views of FIG. 2, respectively. FIG. 2D is a partial view of FIG.

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

FIG. 4 illustrates an exemplary computer system or number of computing resources with which some implementations of the ones disclosed in this document may be utilized. ing.

FIG. 5 has and is constructed by FIGS. 5A-5D as a plurality of sub-views, which FIG. 5 is an alternative according to that disclosed in this document. It provides some alternative (other, alternative) screenshots of some software implementations. FIG. 5B is a screen shot of a software implementation example. FIG. 5C is a screen shot of an example software implementation. FIG. 5D is a screen shot of a software implementation example.

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

FIG. 6C is a flowchart showing some steps of one specific example of detecting the numerical value indicating the oxygen saturation.

6D and 6E show an example of detecting a numerical value representing the depth of breath.

7A, 7B and 7C show flow charts for some alternative methods according to those disclosed in this document. FIG. 7C shows a flow chart for some alternative methods according to those disclosed in this document.

  The inventions disclosed in this document facilitate various modifications and amenable, compliant forms of some alternative (another, alternative) form. Some of the inventions embodied above are shown by way of non-limiting example in this document in the accompanying drawings and the text description below. However, it should be understood that the intent is not to limit the inventions to the specific embodiments set forth herein. It is fully understood that the intent is included in this document even if it is beyond the scope of the literal meanings of this document, or of the wording used in this document or of the drawings attached to this document. It is intended to encompass all variations, equivalents and alternatives, whether or not they are within the spirit and scope of the invention.

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

 Furthermore, some systems described in this document can be configured to measure and / or process signals of a patient, such as those described above, which systems include One or more of any kind used or having any of the plurality of elements, the plurality of elements having (a) a circuit, the circuit being flexible or flex circuit board. (board, embedded or embedded) or flexible on the surface or may form such a circuit board, the circuit being flat Embedded in or located on an elastic substrate or board, the substrate or board has a top surface and a bottom surface, and the circuit is ( i) At least one sensor, which is mounted inside (in, embedded position) or on the surface of the bottom surface of the flat elastic substrate or at a position adjacent to the bottom surface of the flat elastic substrate, and Includes one or more of those 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 receives signals from the at least one sensor, and in some embodiments, further And / or (iii) at least one memory for receiving and / or accepting and storing patient data, and / or (iii) for storing such signals for storage as patient data. Module and / or (iv) at least one data communication module for transferring stored or unstored patient data to an external device, and / or ( v) a control module of one or more of the at least one sensor, the at least one signal processing module, the at least one memory module, and the at least one data transmission module. A command for controlling timing (timing, operation timing) and operation (operation content), and / or the control module for instructing transmission of patient data by the at least one data transmission module; And a command capable of receiving a command to erase and / or wipe data from the at least one memory module. In some embodiments, the system disclosed in this document may have (b) a conductive adhesive (conductive adhesive, conductive adhesive, conductive adhesive). , The conductive adhesive is removably adhered to the bottom surface of the flat elastic substrate, and the conductive adhesive adheres to the skin of the patient or other user. In some non-limiting examples, the system disclosed in this document may be used only in a direction normal to the bottom surface of the flat elastic substrate. It may be possible to pass the electrical signal in a substantially coincident direction, and / or in some embodiments, the system may include a conductive portion adjacent to the one or more sensors. And a non-conductive part. In some embodiments, the electrically conductive adhesive is characterized by a current flowing in a direction substantially coincident only with a direction perpendicular to the skin (ie, "z-axis" conduction, electrical conductivity). Is an anisotropically conductive adhesive in that it has a plurality of regions of a material having

  In some embodiments, some of the devices described in this document are specifically for comprehensive and long-term cardiac monitoring. The features of this type of device, although not required, are lead 1, 1 lead, ECG, volumetric plethysmography (PPG), pulse oximeter, accelerometer, A type of one or more of a temperature sensor and / or a button or other indicator for manually marking a patient event. It is possible to have one. A device of this kind may, for example, utilize up to about 2 weeks of continuous data (although in other embodiments more or less data may be available). Wax), the continuous data of which, in some embodiments, is computer-based (computer connection, etc.). Or it may be downloaded to another computer within a short period of time, in one example only within about 90 seconds (although in other embodiments longer or shorter times may be feasible), The computer connection, whether wireless or wired, in one example, the wired connection is a USB or other available data connection. Companion software data analysis package (companion software data analysis package, accompanying software data analysis package) provides automatic event capture (automatic capture of patient events (events, state changes)). Can be adapted and adapted to enable and / or allow immediate or delayed, local data interpretation in the field. is there.

  Intermittent cardiac anomalties are often difficult for a doctor to detect and / or diagnose because such abnormalities cause the doctor to examine the patient. This is because what occurs during medical examinations and medical examinations is necessary for detection and diagnosis. The devices described in this document are capable of handling this problem, and in some embodiments, the problem is addressed by one or many vital signs, vital signs, blood pressure, pulse, It can be handled by what is a continuous or substantially continuous monitoring of respiration, body temperature, etc.).

  Some alternative, but not exclusive, features include (i) a driven "light" having multiple electrodes that are placed only on the chest of the patient. A "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, which is a conductive / adhesive interface between an electrode and a patient's skin, and has conductivity in the z-axis direction, that is, anisotropic conductivity. (Provided) that allows electrical communication to occur only in the portion between the electrode (an electrode, one electrode) and the skin of the patient immediately below that electrode. , And / or (iii) Data transmission to and interpretation by a local computer that has access to the CCU / and / or ICU personnel. A unique combination of data transmission and interpretation unit and / or (iv) hardware for performing multiple data sources (multiple data from multiple sensors) to aid in diagnosis. It is possible to have one or more of those that may be able to be associated with each other in time concordance.

  In some alternative and non-limiting embodiments, the devices and systems described in this document include: 1) reusability ( In some cases, close to or greater than about 1000 patients) and may be able to recover the cost of the device after only about 10-15 patient exams, And / or 2) electrocardiographic 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 one another for better detection and analysis of arrhythmic events. One or more, and / or 3) highly efficient watertightness or waterproofness (to allow the patient / or wearer to swim while wearing the device), and / or 4) It is possible to provide a comprehensive analysis package for interpreting data almost immediately and on site. Another device to provide a lightweight, thin-walled, durable and flexible device to fit and move with the patient's skin during patient / or wearer motion. In addition, it may be adaptively designed to utilize flex-circuit (flexible circuit, flexible circuit in shape) technology.

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

  FIG. 1 is made up of and has all of the partial views of FIGS. 1A-1P, which shows a device 100 that includes a component side or component side. An upper strip 101, a patient or circuit side 102, one or more inner electrical layers, generally identified by reference numeral 103, and an elongated strip. A layer (an elongated strip layer, an elongated strip layer, and one elongated strip layer) 105. The strip layer 105 can have electronic parts (electronics, a plurality of electronic parts, a group of electronic parts, electronics) on and / or inside the strip layer 105. FIG. 1A illustrates a plurality of elements described herein within what may be considered herein as a device that, in some non-limiting embodiments, is a substantially transparent device. FIG. 6 is a perspective view showing some of the other elements that may be used with the element. More specifically, FIG. 1B is directed to a plan view of the upper portion 101, FIG. 1C is directed to a plan view of the lower, patient side 102, and FIG. 1D is , The first elevational view is directed to the side view.

  Most of the optional electronic components (electronics, electronic components, electronics) described in this specification are one or more electronic component layers 103. , The plurality of electronic components, as shown schematically here, are made of material 104 (for some examples, see FIGS. 1A, 1B, 1D and 1K, and, for example, 1N, 1O, 1P and 1Q), medical grade silicone, plastic or similar, as will be described in more detail below, ie, Using a potting material (potting material, encapsulant, etc.), it is possible to be encapsulated (encapulated), the purpose of the plurality of electronic components (the electronics, the electronic component portion), Functionally disposed relative to the surface of, or within, the elongated strip layer 105, or at a position determined relative to the strip layer 105. Fixed) in the operative position (a position where it can be operated). The potting material or other material, in many embodiments, additionally or alternatively operates the electronics in an environment where water or sweat is used. As described above, it is possible to coat the plurality of electronic components in a waterproof, watertight or waterproof manner. One or more access points, access points, passages, windows, junctions or other functional units 106 may be provided on and / or on any side of the encapsulation material 104 described above. It may be provided to pass through any side, the purpose of which is to access the outside and / or the electronic components located inside or below the functional unit 106. It is in communication with the electronic component section). 1A, FIG. 1B and FIG. 1D show four above-mentioned accesses (access, access passage, entrance, communication passage, window) 106 on the upper side (top side, upper side 101). The accesses 106 can in particular have high Z data communication ports (data communication ports with high impedance or electrical resistance) and / or charging contacts. This upper or component side 101 of the device 100 can be coated with a silicone compound for protection and / or waterproofing, in which case in some cases only the HS USB connector is It is exposed, for example, via one or more ports (ports, doorways, passageways, windows) 106, for the purpose of communicating or transmitting data and / or for the purpose of charging.

  The elongate strip layer 105 includes one or more circuit portions, such as a number of electrical leads, or some other inner layer conductor. A plurality of constituent parts), which are, for example, a plurality of leads 107 shown in FIG. 1D, or the one circuit or a plurality of circuit portions. The purpose of the one circuit or the plurality of partial circuits is to include electronic parts 103 and some pads or contacts 108 having conductivity, 109 and 110, which are described in more detail below (in some examples, 108 and 109 are silver electrodes having high impedance and high impedance / high Z). ) Or copper / silver electrodes for obtaining an electrocardiogram or ECG, and 110 is sometimes the reference electrode). In many embodiments, the strip layer 105 can be or have a flex circuit that can withstand deformation, twisting, bending, and the like. multiple electrical circuit connections that are acceptable (tolerant, absorbable), but robust within themselves (robust, robust, disturbance resistant, structurally stable) Retain robust electrical circuitry connections, so that the plurality of electronic components present inside the flex circuit function as electrical circuits so that the electrical circuit connections are robust. Sex, structural stability)). It should be noted that the electronic parts (electronics, plural electronic parts) 103 and the plural electrodes 108, 109, 110 are shown attached to the layer (strip layer) 105. The elements may be formed inside the layer 105 or otherwise arranged inside the layer 105, or they may be , At least within one of a plurality of working positions having a determined relative position within or adjacent to the layer (strip layer) 105 or being adjacent to the layer 105. That is, they may be arranged in a manner indistinguishable from each other. Similarly, although the plurality of leads or traces 107 are shown as buried (indicated by broken lines in FIG. 1D), the leads or traces 107 (Pathway) 107 may be present on the top or bottom side, but more likely the top part to provide insulation from other telecommunication parts on the skin side. Being on top. The traces 107 are such that the first part thereof is located on the top part (or bottom part), but the following parts are insulating encapsulant or similar. Protective cover (not separately shown), and / or the insulating encapsulant or protective cover may, in many embodiments, be a layer 105. It is a flexible material for maintaining the flexibility as an alternative property for all or most of the.

  Electrocardiographic electrodes 108, 109 and 110 may be placed on the patient side 102 in an exposed condition to contact the patient's skin substantially directly. (Although at least with a conductive gel applied in between) and / or, in many embodiments, the patient side electrodes 108, 109 and / or 110 are as described below. In addition, it can be covered with a conductive adhesive portion. The electrodes 108, 109 and / or 110 may be plated with a highly conductive material that is robust (robust, robust, disturbance resistant, structurally stable), or , Such material itself, and such material is eg silver / (or) silver chloride (silver / sliver chloride), suitable for biocompatibility and high signal quality. Yes, and in some embodiments, the electrodes 108, 109 and / or 110 have a high degree of robustness (robust, robust, disturbance resistant, structurally stable). In one example, which does not limit the scope of the invention, the electrodes 108, 109 and / or 110 may have about 1,000 (1000) alcohols when used with multiple patients. It can be designed to withstand cleaning. Windows or other communication passages or openings 111, 112 (FIG. 1C) can be provided for pulse oximeters, eg, for multiple LEDs and sensors. Such openings (openings, through holes, etc.) 111, 112 (eg, FIG. 1C) are typically provided for optimal bidirectional light transmission to the patient's skin. It is possible to be Alternatively, one or more light conduits 111a / 112a (and 111b / 112b) to be installed are shown in FIG. 1D in an example that does not limit the scope of the invention. 111a / 112a (and 111b / 112b) are arranged in close proximity to electronic components (electronics, electronic components) 103 and / or are connected to electronic components (electronics, electronic components) 103 There is. A wide variety of alternative installations may be available in the specification, some of which are detailed below.

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

  The aforementioned set of LEDs and one or more photodiode sensors (sensors / LED sets) may additionally and / or alternatively include a silicone layer. Coated 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 Figure 1H and / or Figure 1K and / or Figure 1L and / or Figure 1M and / or Figure 1N, Figure 1O, Figure 1P and Figure 1Q, respectively. In the figure, the silicone layers or coverings 121 and / or 121a and / or 121b and / or 121c and / or 121d are replaced by the light conduits and / or 121a / 112a and / or 121d. Alternatively, the sensor / LEDs 111c / 111d / 112c are shown covering / and / or surrounding. LED 111c (one or more of FIG. 1H and / or FIG. 1K and / or FIG. 1L, FIG. 1M, FIG. 1N, FIG. 1O, FIG. 1P and / or FIG. 1Q) may be a red LED. Also, the LED 111d (one or more of FIGS. 1H and / or 1K and / or FIGS. 1L-1Q) may be an IR (infrared) LED and the device (the device, said sensor) 112c (FIGS. 1H and 1K and / or one or more of FIGS. 1L-1Q) may be a sensor. Multiple LEDs that are alternative (alternative, replaceable, selective) and / or additional (additional, can be added to) May have, in the first example, additional or alternative colors, in addition to or in place of the LED light colors described above. 1) and / or LEDs (not shown), similar to those shown in one or more of FIGS. 1H and / or 1K and / or 1L-1Q. Alternatively, the LED may be, for example, a green LED (not shown) that implements additional and / or replacement functions, as will be described in more detail below.

  Some other alternative arrays (arrays, sets, combinations, etc.) or devices (arrangements, arrays, aggregates, arrangements, etc.) consisting of LEDs and sensors are shown in FIGS. 1L and 1M. In the figures, one or more LEDs of the epoxy / light-pipe (epoxy / light-pipe, epoxy pipe or light guiding pipe, one pipe) 121c are provided on the substrate 105a. Inside, it is arranged rather towards the center and one or more sensors or photodiodes are arranged rather towards the periphery. In FIG. 1L, two LEDs 111c and 111d (similar to LEDs 111c and 111d shown in FIG. 1H and / or FIG. 1K, but similarities are in terms of positioning / geometry). Are shown centered relative 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 be There may be one or more sensors, which in this example are two sensors or photodiodes 112c and 112d. In FIG. 1M, four LEDs 111c, 111d, 111e and 111f (similar to LEDs 111c and 111d shown in FIG. 1H and / or FIG. 1K, but with similarities include number, positioning and / or geometry ( geometry) is shown centered relative to one or more sensors, which in this example are four sensors. Alternatively, the photodiodes 112c, 112d, 112e and 112f. 1H and / or 1K and / or 1L, the LED 111c may be a red LED and the LED 111d may be an IR (infrared) LED, and / or The LED 111e may be a red LED, the LED 111f may be an IR (infrared) LED, and the devices 112c, 112d, 112e and / or 112f may be one or more sensors, in this example In, the sensors are four sensors or photodiodes 112c, 112d, 112e and 112f.

When the LEDs (the LEDs, one or a plurality of LEDs) are arranged according to the arrangements shown in FIGS. 1L and 1M, which are arranged more toward the center, they are relatively or relatively conventional. Method, which encloses a centrally located sensor or photodiode with LEDs, and a very large part of the emitted light emitted from the LEDs (the LEDs, one or more LEDs) A geometry may be provided that may be disguised as capturing (much greater percentage, more than 50% etc.). When such a conventional geometry is adopted relatively or relatively, it is wasteful that substantially all of the emitted light that travels away from the photodiode. (Wasted, not effectively used) If one employs the geometries shown in FIGS. 1L and 1M respectively and / or the geometries described with reference to FIGS. 1L and 1M respectively, then a very large amount of light, perhaps of the emitted light, may be used. Of light may be captured by the sensor or photodiode, or in some cases much more efficiently than before (capture). Is done. Thanks to this high efficiency light capture, the number of LEDs required is not at its own heart, unlike the conventional Multi-LED integrated sensor, the light source-sensor unit according to the present embodiment. It is less than the number of sensors with multiple LEDs incorporated in the part). This contributes to a significant reduction in power consumption, but may nevertheless achieve the same or higher quality measurement results. In essence, a geometry of multiple LEDs, such as the combination of red and infrared light described above, is combined with an array of multiple photodiodes (or multiple sensors). It is shown in the figure and described by the text, and the geometry allows the light to be injected into the subcutaneous area of the subject (subject, subject, etc.) (eg, patient, infant, newborn, mother, athlete, etc.). It may be possible to concentrate highly within. The combination of LEDs and photodiodes / sensors described above, in some embodiments, is a High-Efficiency Integrated Sensor, which allows the sensor to capture reflected light with high efficiency. It may also be referred to as a sensor in which an LED is incorporated in the central portion). This arrangement may be implemented to measure SpO2 (peripheral capillary oxygen saturation). It should be noted that in some practical implementations, for example, some of the aforementioned sensors shown in FIGS. 1L and M, respectively, may have a width of about 5 mm ^2. The diameter of the outer circle surrounding the LED may correspond to about 8 mm. In some embodiments, about 3.2 mm may be set as a desired distance from the center point of the red light LED light source to the corresponding center point of one sensor or a plurality of sensors. Well, about 3.7 mm may be set as a desired distance from the center point of the infrared LED light source to the corresponding center point of one sensor or a plurality of sensors.

  This silicone layer or covering 121 / 121a / 121b / 121c / 121d / 121e reduces the amount of light loss for light reflected from the patient's skin, thereby reducing the signal (the signal). Noise) caused by movement of the patient's skin relative to the sensor (the sensors, 112, 121c, 112d, 112e, 112f) may be greatly reduced. unknown. In some embodiments, the silicone layer may be referred to as a light pipe, and in some circumstances the silicone layer is transparent, colorless, And / or may be a silicone having a medical grade. As described in more detail below, the silicone layer or cover 121 and / or 121a and / or 121b and / or 121c and / or 121d and / or lens surface 121e (in this document, 121 / 121a / 121b / 121c / 121d / 121e, but their respective meanings do not change), in this document, in addition and / or substitution, as a light pipe or lens 121 / 121a / 121b / 121c / 121d / 121e. It may be called, but the name means that the element transmits the emitted light (upon emission, the light emitted from another place, the direct light) or reflects the reflected light. Light) and transmits the light, or both of them, as long as they are involved in the light transmission or that the light is adapted to transmit itself. To do.

  In one or more embodiments, thereof encapsulant, encapsulant, encapsulant, potting material, filling within the cavity to enclose an object within the cavity. Material) and / or lens 121 / 121a / 121b / 121c / 121d / 121e may be made from a silicone having a medical grade, which silicone is transparent, colorless, soft and of low durometer hardness. And one or more of Some good examples of specialized silicones, as may be used with those described in the specification, are "tacky gels". (Supplied by several vendors), and the good example is typically a plurality of high-tack adhesives. Body, double-sided adhesive), which are preferably embedded on both sides (on both sides, on both sides of said tacky gel, on both sides of said silicone). , Double-sided adhesive type). By combining a low durometer silicone with a double-sided adhesive that is an adhesive on both sides of the tacky gel, the lenses 121 / 121a / 121b / 121c / 121d / 121e are described above. Electronic sensors (conform to, shape-match, their shape matches those of the sensor and skin, fit well) And, in some embodiments, further includes movement (relative displacement) between the skin, the lens, and the sensor interface. The limitation presents the property of reducing motion artifacts, artificial noise caused by motion, body movement artifacts, noise or artifacts caused by body movements during patient motion. It becomes possible to do. The lens according to the description may additionally and / or alternatively have a heterogeneous composite adhesive strip, in which the lens consists of a composite adhesive strip, two or more different parts. , Composite adhesives 113, 113a) (eg, see multiple options shown in FIGS. 1D, 1G, 1I and 1J) to be trapped between multiple layers. The lens may, in some embodiments, additionally have a raised portion, wherein the raised portion is the composite portion. It has the same size as the opening (opening, through hole, etc.) in the adhesive strip (composite adhesive strip 113, 113a), and sometimes the opening has a rectangular shape, The ridges allow the lens to slightly project from the patient-side surface of the composite adhesive stripe (described in more detail below with respect to FIG. 1K).

  In FIG. 1K, yet another silicone cover or encapsulant used for the sensors and LED sets 111c / 111d / 112c is used. Etc.) 121a may have a convex lens at the same position as or adjacent to the outer cover surface 121b. In many embodiments, the external surface and the cover outer surface 121b and the lens are the same part and / or the lens is the encapsulant 121a. It may be formed by the surface 121b. What is provided by what is described herein is that the device is mounted on the patient or user's body in the chest, or in the forehead (eg in the case of infants or neonates). Whether or not it is a different part, the LED illuminator 111c / 111d for pulse oximetry and one or more photodiode sensors 112c and the skin surface are communicatively interfaced with each other. And a structure and method for interworking and interworking with each other).

  Specifically, as otherwise described herein, the system and / or device 100 used is one or more of the LED emitters 111c / 111d (and / or 111e). And / or 111f) having several selected wavelengths and one or more photodiode sensors (sensors, receivers 112c) may be used. However, the LED / sensor set (combination, 111c / 111d / 112c, a combination of LED and sensor) is tightly coupled to the skin 1001 of the wearer 1000. In order to maximize the possibility of optical coupling, the encapsulation material (encapsulant, encapsulant, encapsulant) and / or the lens 121 / 121a / 121b / 121c / 121d / 121e Of transparent, transparent and medical grade silicone is molded on the LED / sensor set 111c / 111d / 112c (molded onto the LED / sensor set). Alternatively, the lens 121b has a relationship that the lens 121b covers it on the LED / sensor set 111c / 111d / 112c after molding (later, after molding, and after molding in advance). It may be mounted so that a covering relationship) exists. In many embodiments, the lens 121b may be partially spherical, or perhaps essentially spherical, as illustrated in FIG. 1K, although this is not essential and will be described below. See, for example, FIGS. 1N-1Q. Similarly, different shapes of curvature may be useful. The curvature may reduce the likelihood of loss of contact with the skin when the device 100 is moved, whether or not due to wearer movement. That is, movement of the wearer 1000 in FIG. 1K or relative movement of the device 100 with respect to the wearer 1000 results in the lens (121 b) being associated with the skin 1001, or the lens being associated with the skin 1001. , Quasi-rolling contact. Good contact with the skin means that good data acquisition is performed uninterrupted and / or low noise. Some of the embodiments described above and some of the embodiments described below (not directly shown, i.e., may or may not be substitutable relative to what is shown). Or not), or in some embodiments, as described below with particular reference to FIG. 1Q, a thin silicone adhesive. Body 113e is used on or between the silicone layers 121 / 121a / 121b / 121c / 121d / 121e, whereby the silicone encapsulant 121 / 121a / 121b / 121c / Helps maintain skin contact with 121d / 121e. See, for example, the discussion of FIG. 1Q below.

  Furthermore, what is related to the function of maintaining the contact state is the light piping effect (light guiding effect, light pipe effect, light guide effect, light guiding effect, light guide effect). The pipe effect means that the transmission is interrupted by an air gap, the air gap in the material of the light pipe 121a, even though the LEDs and sensors may have different heights. The light pipe is made of the encapsulant 121a / 121c / 121d / 121e (of) with substantially no or substantially no transmission interference. May be achieved when passing through the skin from the emission, a light source such as the LED, a light emitting part, etc. to the skin and vice versa. A path from a light emitter (emitter, emitting part, light emitting part, etc.) to a light pipe 121a / 121c / 121d / 121e, which may have a curved surface (curved surface, outer surface of the cover of the lens 121b) 121b in some cases. And the light pipes 121a / 121c / 121d / 121e, which may have a curved surface (the outer surface of the cover of the lens 121b) 121b in some cases, have no air gap in the path and Since it contacts the skin substantially stably, when it penetrates into the skin (transmission into) and when it penetrates the skin, it is reflected as the return light from the inside of the skin, which is the opposite direction of the reflection. At the same time, and when the material of the light pipes 121a / 121c / 121d / 121e is transmitted again and returned to the sensor (the sensor, 112c) (both transmission and reflection mean the progress of light), the air cap (air gaps, air gaps between the skin and the device), no, virtually no, or virtually no interruptions, transmission interruptions, transmission interruptions, signal interruptions. This reduces the inefficiencies caused by light wave scattering at the air gap interfaces (the interfaces between the skin and the device where the air gaps are). (The air gap allows light to bounce off the skin or other surfaces (bounce off, reflect unplanned, reflect without entering the skin)). That is, the encapsulation of the LEDs and the sensors provides for the absence of air gaps and light pipes, and the curved surface (the outer surface of the cover of the lens 121b) provides: With high quality and low scattering, it is possible to penetrate into the skin and receive reflected light from the skin and bone. The light pipe and the curved surface keep the contact with the skin uninterrupted, and the lens (121b) reduces the amount of signal loss due to skin reflection. Its signal-to-noise ratio is reduced and the data acquisition is improved in terms of its quality.

  Thus, encapsulant materials 121 / 121a / 121c / 121d and / or lenses 121b / 121e of this kind may serve one or more purposes, which in some cases are particularly 1) " A "light-pipe" effect is that a plurality of LEDs and sensors having different heights can be tightly coupled to each other with a consistent quality or not between all LEDs and sensors. Guaranteeing that it is done in high quality even if it is not, and that it is substantially stable and firmly coupled to the skin, it is done so that motion artifacts are reduced. And 2) focusing the emitted light that passes through the skin and reaches the bone, and 3) reflects the reflected light through the skin. Focusing what reaches the photodiode sensors (112c).

  It should be further noted that, as can be seen from FIG. 1K, regarding the curved lens 121b as an optional item, the radius of the lens (the lens, 121b) is changed from the item 1) to the item 3). It means that you can design to maximize The height of the lens (121b) protrudes from the composite adhesive body 113 of the device 100 and digs into the skin. However, another cause of data failure is inhibition of the capillary bed. It may be designed so that it is possible not to penetrate deeply into. Furthermore, it is not always necessary to highly control the plurality of radii of curvature (the plurality of radii of curvature of the lens 121b) and the plurality of angles of the LED lightwave emission. , And said plurality of LEDs used to pass through the skin, for example red LEDs and infrared LEDs and / or green LEDs, realize different emission angles over a very wide range, Therefore, a large number of reflected lights that are different over a wide range are focused back to the sensor by a plurality of curved surfaces (curved surfaces, the outer surface of the cover of the lens 121b) that are different over a wide range. For that reason, the need does not exist. That is, the curved surface is useful for maintaining contact during the period of motion (accidental or intentional), and the curved surface is the angle at which it penetrates the skin. And the angle of reflection back to the sensor is less important. In other words, many different radii of curvature, many different radii of curvature that the lens 121b has, have very small differences in the transmittance / reflectance of the data / (or waves). For this reason, it is effective, and the wide-angle emission angle of the LED makes it possible to take a variety of radii (radii, radii of curvature of the lens 121b) well (takes care of what might be a variety of radii, If an LED having a wide emission angle is used, it is not necessary to carefully determine the range when there are a plurality of radii of curvature of the lens 121b). Rather, the curvature, the curvature of the lens 121b, may have a number of limitations in maintaining contact due to the movement of the device 100, for example, a flatter curve. curvatures) will not roll easily, and very small radii of curvature will not send or receive much data.

  In some embodiments, a radius of curvature found to be useful for a device having multiple LEDs and multiple sensors within a compartment measuring about 12.6 mm by about 6.6 mm is about 20 mm to about 40 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 be further noted that multiple LEDs may be present on one or the opposite side or on both sides, or, perhaps, at substantially even intervals around one sensor. That is, they may be placed in more than one position each, 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 illustrated in FIGS. 1H and 1K and / or, for example, FIG. 1L- There may be one interpretation for some arrangements shown in any one or more of FIG. 1Q. A typical pulse oximetry electrical circuit is one for each wavelength (typically other light, including red light, infrared light, and in some cases green light, or for some additional examples described below). , Long time averages of red light and / or infrared light (long time averages), long time average value of intensity of each signal, time of a plurality of intensities of each signal in time series The average value of those existing in the section, the long-term average value of the data represented by the waveform, the one with the longer time section than the other time average value among the time average values, the red light used for measuring oxygen saturation And a time average having a longer time interval than the time interval of the time average for infrared light)) one light source (LED) is used. However, the devices and / or methods herein may utilize multiple light sources for each wavelength. This allows for extensive interrogation of the capillary bed within / on the surface of the patient / wearer in order to reduce the effects of local motion artifacts. May be allowed (allowed). Similarly, multiple sensors may each be used for the same or similar purpose or advantage.

  Furthermore, a DRL circuit (driven right-leg circuit, a right leg drive circuit, a right leg drive circuit, a circuit in which the right leg is driven, a right leg drive type circuit) and / or a proxy DRL circuit (proxy driven right-leg circuit, proxy) DRL circuit, a pseudo right leg drive circuit) ") and pulse oximetry can be combined to obtain another effect. The DRL circuit, the surrogate DRL circuit, and / or the right foot drive circuit, whether for the chest, forehead, or other electrode placement, may be used for common mode noise ( Common mode noise, in-phase noise, in-phase signal mixed as noise, and power line noise, which are present without being removed, are capacitively coupled (capacitively) inside the pulse oximetry sensor. It is possible to eliminate those that may / may be coupled to reduce the effectiveness of the sensor. DRL circuit (driven right leg, right leg drive circuit, right leg drive circuit, right leg drive circuit, right leg drive type circuit) and / or proxy DRL circuit (proxy driven right leg, proxy DRL circuit, pseudo right leg) Drive circuit))) and a lens as described in and for 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 the It is possible to For driving electrodes, refer to the further detailed portion described below.

  Therefore, it is possible to measure the arterial blood oxygen content using several optical signals (also known as heartbeat optical signals). Are typically obtained from a red light pulse signal source and an infrared light pulse signal source, and these red light pulse signal source and infrared light pulse signal source are different from each other depending on the presence or absence of oxygen hemoglobin. Indicates the absorption rate. In short, a transmissive system is used with a light source and an optical detector. As will be described below, in many embodiments, a light pipe enclosing one or more of the aforementioned light sources and / or one or more of the aforementioned sensors or sensors may be used. , In particular, the light pipe for encapsulation in the sense that there is substantially no air gap, the irradiation efficiency when the light is irradiated on the skin (efficiency, the light emitted from the light source was actually irradiated to the skin) Part of the ratio to the emitted light) and / or the efficiency of capturing a plurality of photons that would otherwise be lost when the emitted light is collected. May be used for.

  There are some typical reflective systems here, which often have some advantages, which are invasive. (intrusive, property of external signal invasion, property of external signal invasion, mutual invasiveness, invasiveness, etc.) is low, and it is probably highly portable. As described in this document, some such reflective systems typically employ red and infrared light sources and photodiode-type sensors or detectors, or Adopt multiple configurations for those parts. As also described in this document, one embodiment / method provides one or more photodiodes / sensors / detectors that are centrally located and have a wide sensing surface. LED light sources, often one or more LED light sources, each of which is a red light LED light source and an infrared light LED light source, are adjacent to the photodiode (the photo-diode, light sensor, etc.). Or, it is adopted in a line so as to surround the photodiode (the photo-diode, optical sensor, etc.). Another arrangement, as also described in this document, is a centrally located central LED set consisting of one or more light sources and arranged by wavelength type (red light, infrared light). One or more of each wavelength type, such as one or more of a plurality of wavelength types) and a plurality of photodiodes or photosensors, It has a wide detection surface and surrounds the central LED set. An arrangement of this kind uses two, three or four detectors of this kind which surround the LED, so that they scatter. And radiate out) to collect a greater amount of light that passes through the skin and other tissues, see, eg, FIGS. 1L and / or 1M.

  Yet another embodiment provides reinforcement structures (structural enhancements, etc.) that enhance and / or are located around the light source and / or one or more photodiodes described above. May be adopted. First, one or more of the above-mentioned reinforcing structures arranged in connection with the above-mentioned central LED arrangement will be described, but the following will be referred to as the above-mentioned central sensor arrangement. ) Or related thereto. These optical enhancing structures may minimize intrusion into the collection area, light collection area, light detection area, and These reinforcement structures may reduce the area of the photodiode area (the area where the photo-diode (such as a photosensor) is located, the sensor area) or may reduce the number of photodiodes. As a result, cost benefits and / or increased efficiencies may be obtained.

  In FIGS. 1N, 1O, 1P and 1Q, in the light pipe 121d, on the substrate 105a, a plurality of central LED light sources 111c and 111d are surrounded by a barrier 122 (in FIG. Is also specified by the symbol B1 in FIG. 1), the photodiodes (photo-diodes, photosensors, etc.) 121c, 121d, 121e, and 121f located near the outer circumference of the light sources are isolated (isolated). Optically blocked). Also shown is an optionally added outer barrier 123 surrounding the sensor area. Barrier 122 (ie B1) and / or outer barrier 123 (ie B2) are preferably opaque and / or both red and infrared (or any other of the light in use). Of light rays, eg, green), thereby preventing crosstalk between the LED and the sensor, ie, preferably a plurality of light rays emanating from the LED. Rather than wanting some of them to reach the optical path that is incident on the sensor directly (without first reaching the skin), all of the light emitted from the LEDs is incident on the skin. Want. Desirable surfaces for the barriers 122, 123 are diffuse-reflective (generally relatively absorptive and / or specular). Absorption or specular reflection is stronger than relative, diffuse reflection)). An example may be transparent aluminum oxide. Another example would be a white paint with surface irregularities. The operation is illustrated and textually described in connection with Figures 1P and / or 1Q, see below for discussion.

  The shape and size of the barrier 122 can be appropriately selected according to the shape and size of the LED light source, here, the plurality of light sources 111c and 111d. For example, the barrier 122 may be circular as shown, but may be square or rectangular in shape or other shape (not shown) to enclose the plurality of LEDs 111c, 111d. (More notably here, more or fewer light sources may be located within or surrounded by the barrier 122). Similarly, the width or thickness dimension of the barrier 122 and the materials used for the barrier 122 may be variable or may vary according to requirements or goals. It is possible that the relative opacity of any individual material (in comparison to other optical properties, etc.) will be at the individual specific level of opacity, To achieve a diffuse-reflectivity, such as the opacity of the barrier as a component) or a relative (in comparison to other optical properties, etc.) It may mean thinner or thicker than the required width dimension (even if a material does not have opacity, if the thickness of the material is thick, opacity may be achieved for that material, Conversely, the width dimension may be dependent on the material, or vice versa, in that if the material is thin, the material is not opaque, but rather translucent). May be. Individual specific wavelengths of light, ie the type of light used, and / or one sensor type or each type of sensors, and / or relative and / or as a whole Some geometrical relationships (sensor-to-light source, sensor-to-sensor, and / or light-source-to-light source) such that the relative opacity is achieved in relation to the individual specific wavelengths. Used for the relative dimensions and / or material, and / or the relative opacity in relation to the individual specific wavelengths. May be taken into account when selecting the relative dimensions (the relative dimensions, etc.) and / or the materials to be used. How many of the relative thicknesses may be more strongly related to the type of material of which the barrier is made, its opacity or relative diffuse reflectance. There may be situations. In some embodiments, the barrier may be a machined material, an oxidized material, or other similar material, although in some other embodiments, the barrier is , Synthetic resin, for example, molded synthetic resin. For applications where red and infrared light is used, a driving consideration is that using the material is probably opaque, preferably both at 660 nm and 940 nm. Or it may be reflective or diffusely reflective. Thus, in some cases very thin aluminum meets this requirement, as well as thicker synthetics.

  Some options for the barrier 122 are primarily sideways propagation of emitted light from the LEDs (eg, in the previous case, eg, red or infrared light from LEDs 111c / 111d). It may be intended to provide an obstructing optical barrier (e.g., propagation), and the barrier 122 preferably has the same height as the light exit window of the LED, or slightly less. It has a high height. Desirably, the barrier 122 also has a width dimension sufficient to prevent optical crosstalk of multiple rays that never enter the skin or the scattering material, but the width dimension is It is not thick enough to prevent light from the LEDs scattered from the skin or other flesh material from reaching the photodiode detectors located outside the barrier. It is not.

  An optional external (external, external to the light source area, external or peripheral to the light source-sensor unit) barrier 123 may also be employed. This helps collect the reflected light from the patient or user. For outer barrier 123, size and thickness dimensions and materials may be considered as well (Similar, similar to barrier 122), the difference being primarily in terms of light collection. That is not to say that it emits light.

  Due to their developments (such as the improvements described above), some outside, as described herein, ie, with respect to FIG. 1N / FIG. 1O and / or FIG. 1P / FIG. 1Q. Where improvements with external detectors are provided, an optical collection structure is added, which collection structure contains several detector diodes. 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 as to reach one or more of the detectors. , Part of the light (which would not have been captured if it had not been reflected from the barrier), may be induced or reflected. It should be noted that some detectors located in the center (central, inside the light source area, inside or in the center of the light source-sensor unit) Therefore, a plurality of light sources, which are used in combination with a plurality of light sources (not shown) which are isolated from each other by a method different from that of the outer detector, are also similar to the above-mentioned ones. You may have matters.

  Some structures that are desirable when employing this type, such as the light source / sensor embedded light pipe disclosed in this document, are transparent optical media, here the light pipe material 121d. You may have. The light pipe material has a shape that is located inside and / or surrounded by a barrier 122 that is relatively opaque (as compared to the opacity of other optical elements, etc.). (See, for example, FIG. 1Q, as will be described in more detail below), the light pipe material may also be used as light sources 111c and 111d (and / or other light sources, if present). ) May be present in the barrier 122 and / or outside the barrier 122 (between the barrier 122 and the barrier 123) diode detectors 112c, 112d, 112e and / or 112f (and / or other photosensors, if present), which light sources and photosensors are within their structure 121d. Is buried with little or substantially no air gap between the and light pipe material. Detector devices 121c, 121d, 121e and / or 121f are inserted into the optical medium, i.e. the light pipe material itself, and molded into it. Or it may be placed in a number of premolded cavities in the optical medium. Some optical structures when employing this type may be collectively referred to as "light pipes."

  The shape of the light pipe structure 121d and / or the surface 121e can be selected in various ways, depending on the number and size or shape of some of the detector diodes mentioned above, and the light pipe structure 121d. And / or the shape of the surface 121e may be scattered light received in some way, i.e. from skin or other flesh material not directly contacting or located above any detector diode. Capture (scattered light) and confine the scattered light by total internal reflection (total internal reflection, inward total reflection, total internal reflection between multiple barriers), and , By using a surface having diffuse reflectivity, it is possible to deflect the directions of the light rays to one or more of the photodiodes described above. It may be designed in such a way as to be achieved. With such a method, light that would otherwise be lost in a conventional design is captured by some devices according to some of the above-described embodiments. 1N and 1O, the epoxy body (light pipe) 121d is relatively flat (relatively, by comparison with other optical elements, etc.), ie, with a relatively flat surface 121e. However, while having something that is neither concave nor convex, the epoxy body (light pipe) 121d may be a bend that cooperates with the barrier or barriers disclosed in this document. FIG. 1Q shows a relatively or substantially flat surface 121e.

  Also shown in FIG. 1Q is an optional thin layer silicone adhesive (adhesive, adhesive, adhesive, adhesive) 113e present on surface 121e. The thin-layer silicone adhesive 113e reduces the movement of the device (movement, relative movement, etc.) with respect to the skin, and emits light (light transmission, light transmission, light transmission, light transmission, light emission, etc.) and receives light. The device may be used to adhesively fix it relative to the skin (not shown here) so that the (light reception) properties are improved. If an adhesive of this kind is used, it preferably has the practical possibility that it does not interfere with or cause refraction of some light waves passing through it ( may be as thin as (operably possible, practical). A thickness of 0.2 mm may be so operable to satisfy it. Furthermore, this (it, the relationship between the refractive index of the adhesive and the refractive index of the light pipe) means that the refractive index of the adhesive is epoxy / encapsulation / light pipe 121 / 121a / 121b / 121c / 121d / 121e. It may be desirable for it to be similar (similar, similar, approximate, substantially coincident, equivalent). This selection of indices of refraction similar to each other may be useful or may be made depending on the material and thickness of the adhesive to be used. For example, a suitable similarity in refractive index may result from or reach a practical thickness of 0.2 mm.

  1P and 1Q show some operative examples and / or some alternatives. Although a light pipe is not shown in FIG. 1P for the sake of simplicity, it may be considered as a practical variant, and this figure shows some light waves to be emitted. Wave emissions, lightwave emitters, emitted lightwaves, etc.) A, B, and C are shown as emerging from the exemplary LED 111c. Light wave A is a relatively direct (relatively compared to other light waves) emitted light and does not collide with any obstacle on the path from the device to the skin (not shown). Yes, in contrast, the lightwave B is shown as reflecting away from the barrier 122 (note that some lightwaves are described at some times, partially). However, it is understood that, for example, light energy is better understood or better understood as multiple photons, as is more specifically understood as emitted light and / or collected light. It may or may not be that light energy, regardless of its form, is assumed in this document.The less desirable one is light wave C, which is , Is not shown as reflecting away from the barrier 122, and this light wave C is here mostly, if not all, of the plurality of light waves emitted from the LED. Illustrated to emphasize that it is desirable to follow a path for exiting the area (the LED area, where the LEDs are located) and entering the user's skin (not shown here). The light reception is illustrated in relation to the exemplary sensors 112c and 112d, in which case FIG. 2P shows a relatively direct (compared to other light waves) direct. , A light wave D is shown as straight light, which travels straight without impinging on other objects, which light wave D enters the sensor area and is captured by sensors 112c and / or 112d. A reflected light wave E is also shown, which light wave E may be reflected away from the barriers 122 and / or 123. Note that the substrate The bottom surface (floor, floor, floor surface, base surface, etc.) of 105a, that is, the top surface also has diffuse reflectivity for the plurality of light waves, and these light waves are finally collected by the sensor (sensor collection, sensor 112c, and sensor 112c). (Or capture by 112d) may assist in reflecting.

  FIG. 1Q shows one or a plurality of light pipes 121d, and further shows a thin layer adhesive 113e as an option (optional, optional element, selected part). The relative indices of these materials (relative, in relation to the indices of refraction of other optical elements, etc.) of these materials affect or affect the light passing through them. It may be absent or greatly affected. What is desired is to equalize the indices of refraction (similarlity, to equalize the indices of refraction among the elements) to minimize refraction. Even so, partial refraction may appear, for example, in FIG. 1Q by emitting a light wave B, and partial refraction appears in the collected light waves E and F. However, here, the light wave F differs from the light wave E in that it is not reflected light from the barriers 122 and / or 123 like the light wave E. Light wave B is illustrated as both reflecting and refracting. Relative selection of material, size and shape of several structures to improve efficiency in light emission and / or light capture. Towards managing the reflectivity and / or the refractive index in relation to the relative (relative, other optical properties (eg, refractive index for reflectance, refractive index for reflectance, etc.)) It is possible to support.

  Returning to the description of the multiple variations for 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 (layer of the adhesive 113) 113 is, in this aspect, a double-sided adhesive, which double-sided adhesive is applied to the bottom surface 102 and the second side of the device 100, Its second side is probably a different type (adhesive or adhesive applied to the bottom surface 102) differently to be adhered to the skin (not shown) of the body as a patient. It will involve the body (adhesive). Different types of adhesives may be used, in that the material selected as the partner to which the adhesive layer (adhesive 113) is to be adhered differs, and those materials may be used. Is typically the material of the circuit or board to be connected to the device 100 and the patient skin on the patient side (not shown separately). And. A protective backing 114 can be used on the patient side until it is desired to be worn on the patient. It should be noted that in many applications, the adhesive 113 will only be conductive in one direction or substantially one direction, eg, the axis normal to its adhesive surface. Is desirable in that it has anisotropy. Thus, good electrical contact for signal transmission can be achieved with the aforementioned electrical contacts or the aforementioned adhesive to the electrodes 108, 109 and 110. It should be noted that the corresponding one or more light apertures 111b / 112b are shown inside the example adhesive body 113 of FIG. 1D, whereby pulse oximetry, Light is passed through the light apertures 111b / 112b and inside / to the layer 105 to effect the transmission of optical data typically related to arterial blood oxygen saturation). That is, the light conduits 111a / 112a existing so as to penetrate therethrough are transmitted together.

  In some embodiments, the adhesive 113 can be positioned or placed on the device 100 in a substantially permanent or some degree of replaceability. In some embodiments, the device (device 100) does not have the adhesive 113 (or some implementations, as shown in FIGS. 1A-1D and / or 1G). In the aspect, the one having the adhesive body 113) can be reusable. In many cases of this type, the adhesive layer 113 may be peeled off and replaced with another one prior to each subsequent use (subsequent use) of the device. Although possible, re-use of and with (re-use of and with, re-use of only layer 113 and re-use of layer 113) is not hindered. For the first or second and subsequent use of the device with the replaceable adhesive layer 113, the user wearing the device on the patient, for example a doctor or technician or the patient himself, should be in electrical continuity. There is a possibility that the adhesive body 113 that conducts a signal by means of conductive transfer is attached to the patient side 102 of the device 100. After that, the protective backing plate 114 is peeled off, and the device is attached to the patient and activated.

  The activation of the device can be done in many ways after it has been worn by the patient / wearer, and in some methods it can be preset as follows: No affirmative interaction is required from the doctor, the patient, or anyone else, because it is triggered by inertial forces (inertia, inertial resistance, blood flow inertial forces) and / or In the pulse oximeter start-up, and subsequent to those start-ups, the device is automatically started, in one example the device start-up being a sufficiently small input (movement in the case of inertial system or pulse oximetry). Is performed in response to the acceptance of the light reflection of blood flow) for a certain button at the position of the access passage 106 or close to the electronic parts (the electronics, the electronic parts 103). Within a certain position, a patient can be placed to activate or deactivate the device, or to be able to mark certain events as needed. In a preferred embodiment, the device is worn for a period of time, such as two weeks, to acquire data substantially continuously or is established and established in or by the system. It can be worn intermittently at such time intervals.

  At the end of the monitoring period, the doctor, technician, patient, or other person may then remove the device (device 100) from the patient's body and, in some cases, remove the adhesive. In some cases, using alcohol, removing and establishing a data transmission connection for data transmission, thereby downloading the data, the data transmission being, for example, by wireless communication, or This is done by inserting / connecting a USB or similar data connector. The data is then processed and / or interpreted and, in many cases, the data is immediately interpreted as needed. The power source on the substrate can have a battery, which can then be recharged between one use and the next, and in some embodiments, the charge can be recharged. The battery can be fully recharged quickly, such as within about 24 hours, after which the device should be considered ready for the next patient or next use. Is possible.

  Here, it is possible to use some other conductive adhesives. 1E, 1F and 1G show another conductive adhesive 113a of this kind, which is shown in a bottom view in FIG. 1E and in a side view in FIGS. 1F and 1G, respectively. (Shown as being coupled to device 100 in FIG. 1G). In some embodiments, its conductivity can be anisotropic, as described above, and in some examples the Z It is predominantly, if not entirely, electrically conductive in the axial direction and its Z-axis direction is perpendicular to the plane of the paper of FIG. 1E (inwardly to and / or in the plane of the paper). And / or, in the embodiment of FIG. 1F, perpendicular to or transverse to the axis of device 100 that is long and horizontal.

  This specific embodiment has a composite adhesive body 113a composed of two or more different parts, which composite itself comprises one or more non-conductive materials. It has a portion 113b and one or more conductive portions 113c. The adhesive composite (adhesive composite) 113a may be adhered to a patient on one side while the other side is a device, as described above for the adhesive 113. It can be used on both sides so as to adhere to the bottom surface 102 of 100 (see FIG. 1G), so that one or more conductive parts 113c are integrally mounted on the device 100 for electronic monitoring. The plurality of electrodes can be installed in a state of being in contact with each other in an electrically transferable state and / or an electrically conductive state. While the electrodes work better when electrically isolated or insulated from each other, each electrode makes electrical contact or transmission with the skin of the patient, The adhesive is further arranged in a more specific manner, as described below, in some embodiments.

  As shown in FIGS. 1E and 1F, the plurality of conductive portions 113c insulated from each other are arranged so as to be separated from each other by a body portion (non-conductive portion) 113b having no conductivity. They (these, their conducting parts 113c) are then, as can be seen from some of the previous examples, and as more specifically and systematically shown in FIG. 1G (notice that their scale is (Adhesive body 113a is exaggerated, and is therefore not necessarily shown to be an exact match with multiple electrodes of device 100). In some examples, the plurality of electrode areas 113c (the electrode areas, the plurality of conductive parts) are conductive hydrogels (hydrophilic polymers containing a large amount of water), It may or may not have an adhesive property, and in some examples, the electrode areas 113c may be made of an adhesive conductive material. The adhesive conductive material is, for example, 3980 Corp.'s 9880 Hydrogel adhesive (3880, 3M Company, St. Paul, Minn.). The electrode areas 113c can then be insulated from each other by a non-conductive material 113b, which may be, for example, 98M tape from 3M Corporation or 3M Tape. Double-sided Transfer Adhesive 9917 (3M company located in St. Paul, Minnesota). If another layer 113d is additionally used, it may be 3M 9917 adhesive with a non-conductive material 113b of 9836 material. Due to their structure, the electrical paths of the plurality of electrode areas 113c in the Z-axis direction (perpendicular to the paper surface of FIG. 1E and, in FIGS. 1F and 1G, vertical / lateral directions) are determined. As the impedance decreases, the plurality of electrodes have the same plane as the paper surface in the X / Y (X / Y, X or Y) direction (see FIGS. 1E, 1F and 1G). Direction, and in FIGS. 1F and 1G, a direction that is horizontal and a direction that is vertical to the paper surface.), The effect of increasing the impedance of the electrical path is obtained. Therefore, not only the device is attached to the patient by the adhesive strip composed of composite (composite, two or more different parts, heterogeneous molding, composite) adhesive part, but also the plurality of electrodes are It may also be ensured that it is electrically connected to a plurality of conductive parts of the adhesive strip, whether it is one electrode or three electrodes as shown, In addition, the combination of the conductive portion and the non-conductive portion can realize reduction of signal noise and / or improvement of noise-free characteristics. When the electrodes move relative to the skin, a noise is generated, that is, a plurality of electrodes that can be electrically transmitted to / through the gel via the gel. The electrodes can move relative to the skin, which can cause noise. However, one or more conductive adhesive parts in the composite adhesive body are connected to the corresponding electrodes and then attached to the skin so as to be substantially immovable, so that the respective electrodes are substantially attached to the skin. The fixation of the electrodes is maintained, whereby the movement of the electrodes with respect to the skin is reduced or even eliminated. Once such motion is eliminated, the noise is then removed, which provides a clean signal, which allows for monitoring of cardiac P-waves. Yes, the cardiac P-wave enhances the ability to detect arrhythmias not otherwise detectable. Further description will be given below.

  In some embodiments, an optional additional structure 113d that is componentive and / or electrically insulative is shown in FIGS. 1F and / or 1G. As shown in FIG. 3, the device 100 may be further implemented to thereby provide structural and insulative isolation between a plurality of electrodes mounted on its bottom surface 102. It is possible (see FIG. 1G). 1F and 1G, the structure 113d is shown in a separated state, but the structure 113d has the above-mentioned insulative adhesive (the non-conductive part, the body) shown in the drawings. Part) 113b.

  You may use another thing about the said adhesive part. In some embodiments, a composite adhesive strip consisting of two or more different parts, having one or more motion artifact mitigating properties is used. May be. 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, hydrophilic gel adhesive) may be used, and the hydrogel adhesive is provided in one continuous sheet. Embedded, the continuous sheet is composed of a laminate of a plurality of adhesive body, the laminate is the selected area of the device or the entire footprint of the device. Cover the entire trajectory drawn by the part covered by the device as it is moved over the skin. The hydrogel adhesive itself has strong adhesive properties, and the hydrogel adhesive is adhesive with any of the adhesives including the composite adhesive stripes. 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 the reduction of motion artifacts may be another placement method of placing the device on the sternum vertically to the sternum. The placement method results in reduced motion artifacts with respect to one or more of ECG signals, photoplethysmograms, and oxygen saturation signals.

  In some embodiments, an improved composite adhesive has a water-proof encapsulation of the hydrogel adhesive to prevent a reduction in ohmic impedance that causes a decrease in signal amplitude. You may. This may also help prevent degradation of hydrocolloid adhesives, hydrocolloid adhesives, hydrocolloid adhesives. In particular, several layers may be used, as shown in FIGS. 1I and 1J as another example without limiting the scope of the invention. In what is described in the specification, the first layer is a hydrocolloid, which is an adhesive designed for long-term skin contact by absorbing sweat and cells. And the second layer is also a layer designed for long-term skin contact, but this second layer insulates the third layer from contact with the skin. The dimensions of the second layer, which are smaller than the other layers, form a gap between the first layer and the third layer. When the first and third layers are joined together, a watertight seal is formed around the second layer. This layer, that is, the second layer, further insulates the hydrocolloid (the first layer) from the hydrogel adhesive (the fourth layer), and the hydrocolloid (the first layer) is formed. Layer) to protect the adhesive properties of. In that case, each of the third layer and the fifth layer is a generally waterproof layer, and each of the layers is an electrically insulated double-sided adhesive body. The two layers encapsulate the hydrogel adhesive (fourth layer) and prevent "electric shorts", which will be described later with respect to the fourth layer. The fourth layer is the hydrogel adhesive which is the conductive element in this embodiment. It is necessary that the three lands (lands, isolated regions, islands) of the fourth layer hydrogel adhesive be kept electrically insulated from each other. However, since the high-cold colloid in the first layer absorbs sweat, the first layer is also conductive, and the first layer is an “electric short circuit” between the three lands of the fourth layer hydrogel adhesive. Can result in 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 detected by that embodiment. This temperature measurement may be performed using a single sensor or multiple sensors, as described herein. In some embodiments regarding temperature, the infant or neonatal body temperature may be the data sought for capture, or the body temperature (temperature, infant or neonatal body temperature, etc.) is It may be used with that of other users, adults or others.

  Infant and / or neonatal temperature sensing may be of great assistance in monitoring health. Using a forehead or other site may be one of the suitable uses for such applications. Another possible combination of several uses is to measure the temperature of both infants and mothers involved in the so-called "Kangaroo Care, a parenting method in which parents hold their baby directly on their bare skin". Method and apparatus. For preterm infants, there is evidence that constant contact with the skin of the parent or real mother is more beneficial than placing it in an incubator. There is also evidence of low mortality.

  An apparatus 100a for performing temperature sensing (temperature sensing, body temperature measurement, temperature measurement) at two locations (dual, multiple locations, dual, with respect to position and time) is used to attach the apparatus to an infant. The fitting 1000 and mother 1010 or ambient air 1011 along with the ambient air 1011 are shown in the accompanying drawing, FIG. 1R. The substrate 1105 is preferably a small, flexible circuit board, which in some examples has a size of about 20 mm x about 30 mm. The circuit board 1105 may be arranged so as to include the circuit section 1103, and the circuit section 1103 may measure, for example, a relative XYZ coordinate position (position with respect to reference XYZ coordinates) and / or It has a part for measuring acceleration (sensing acceleration, an acceleration measuring part, an acceleration sensor) and / or a part for performing wireless communication for Bluetooth (registered trademark) or data / signal, and further, in many examples, 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 (in FIG. 1R, the circuit part Not all of the multiple component choices are shown separated from each other). The device 100a may be attached to an infant using an adhesive (an adhesive, an adhesive, an adhesive, an adhesive, etc.), and the adhesive may be, for example, a composite adhesive shown in FIG. 1R. It may be a disposable type, a medical grade, and a double-sided adhesive body, which is an adhesive body 1113 composed of the above different parts.

  Each of the two temperature sensors (temperature measuring elements) 1111a and 1111b includes two opposing side surfaces of the device 100a (an alternative opposing sides, a parent side and an infant side, and two opposing side surfaces). 1101 and 1102, and the temperature sensors 1111a and 1111b may be thermally insulated from each other, and at the same time, the temperature sensors 1111a and 1111b are often It is also waterproof, watertight or water resistant. A layer (heat insulating / heat insulating layer) 1103a for thermally insulating or insulating realizes the heat insulating effect of the electronics (circuits) 1103 and / or the two temperature sensors 1111a and 1111b. Good. A further spacer 1103b penetrates the heat shield / heat insulating layer 1103a in order to realize a passage for electrically connecting the temperature sensor 1111b to the electronics layer (electronic parts layer, circuit part) 1103. It may be installed as described above. A silicone bead 1104 may be installed for thermal insulation and to assist in providing a waterproof and water resistant seal on the "infant side" 1102. Well, the silicone cover 1121 may also provide a waterproof or water resistant barrier on the “parent side” 1101. The temperature sensor 1111b arranged on the “parent side”, that is, on the upper surface side, that is, on the outer side (exposed side) 1101 may slightly protrude relative to the surface of the cover 1121. In one embodiment of the present invention, a thin layer / thinner layer covering the protrusions of the temperature sensor 1111b may be provided, which comprises a covering material and / or a silicone. Good. The temperature sensor 1111a located on the "child side", i.e. on the patient side, i.e. on the circuit side 1102, is protruding beyond the surface of the adhesive 1113. past the adhesive), or protruding through the adhesive and / or installed exposed, or additionally / substituting, waterproof or watertight Alternatively, it may be coated with a thin layer having a protective agent in order to realize water resistance.

  The thermally insulating layer (heat insulating / heat insulating layer 1103a) may realize one or two or more functions. It (It, its thermal barrier / insulation layer 1103a) reaches the equilibrium state (equilibrium, thermal equilibrium state, where the temperature of the temperature sensor and the infant's body temperature are the same) when the "infant side" temperature sensor 1111a reaches it. Accordingly, it may be possible to provide the infant's “deep body temperature (core temperature, temperature of internal organs that is not easily affected by environmental temperature)” with high accuracy. It (It, its thermal barrier / insulation layer 1103a) may additionally or alternatively shield the infant's temperature measurements from the mother's or ambient temperature. It is not essential that the "mother's" temperature sensor 1111b provides the mother's core body temperature with high accuracy. Typically, the function of the temperature sensor 1111b is to distinguish between the condition where the infant is in direct and direct contact with the mother's skin, i.e. the infant is in relative contact with the mother. Would provide a relative measurement (difference between infant and mother's body temperature) to determine whether they are in contact or in relative contact. If the infant is facing the wrong way, but is still in "hug (pouch, pouch, infant held by mother, mother's pouch or pocket)," the sensor, The measured value of the temperature sensor 1111b) represents the ambient temperature of that environment (that environment's ambient temperature, the temperature around the device in the pouch, etc.). When the infant is outside the pouch, the measurement value of the sensor (the sensor, temperature sensor 1111b) indicates the room ambient temperature (the room ambient temperature, the temperature around the device in the room). The relative differences (the relative differences, the relative relationship between the measurement value of the temperature sensor 1111b and the measurement value of the temperature sensor 1111a) is what kind of posture the infant has, that is, the infant has In contact, or in close proximity (but not in contact with) with the mother in a controlled (acceptable) "hug" environment, Alternatively, it can be construed as providing an indicator (an indication, identification information) indicating whether or not it is located outside the (pouch, pouch, mother's bosom) in an environment further away from the mother.

 Alarms (alarms, stimuli for warnings, etc.) from devices that are wirelessly connected by Bluetooth® or otherwise, to the mother (or an expert to manage health), the infant no longer wants It may be used to warn that it is not properly positioned or that the infant is no longer inside the "(pouch, pouch, mother's pocket)".

  Some other embodiments of those described in the specification can include a driven right leg (DRL) electrocardiogram (ECG) circuit, the DRL The electrocardiogram circuit comprises one or more electrodes ("Driven Chest electrodes") used only on the chest. In addition to the plurality of electrodes used to measure a single or multiple lead electrocardiographic signal, device 100 provides common mode noise, Another electrode can be used to reduce the in-phase noise, the in-phase signal mixed in as noise, and the other electrode can be, for example, the reference electrode 110 (eg, FIGS. 1A, 1C, 1D and (See FIG. 1G) can be used. This type of electrode can function in a similar manner to a commonly-used DRL (driven right leg) electrode, but in this embodiment, Placed on the patient's chest rather than on the right foot of the foot, but nevertheless this third electrode / reference electrode can serve as the foot electrode. Therefore, it can be considered that the chest electrode is a surrogate (proxy) right foot driving electrode that simulates the right foot electrode and / or realizes the same function as the right foot driving electrode. It is possible. A circuit, or part of an overall circuit, designed to operate in this way is aimed at ensuring circuit operation stability and adjusting the overall frequency response characteristics. In addition to filtering, it is possible to have multiple stages of amplifiers to achieve gain. This type of circuit is capable of applying a bias to adjust the common mode bias of the electrocardiogram signal. This embodiment with a chest drive electrode provides a differential or instrumentation amplifier, in order to reduce common mode noise (common mode noise, common mode signal mixed in as noise). It can be used in combination with an amplifier or measurement amplifier). In this aspect, the sense electrode can be used as one of the plurality of electrocardiographic electrodes. Instead, the differential electrocardiogram signal is referenced to ground or to some other known voltage or ground voltage or ground voltage. If other known voltage is used as the reference voltage), a single-ended electrocardiogram amplifier (single-ended (a system that expresses the positive and negative of the signal at the voltage level with a single signal line and transmits)) It is possible.

  Circuits or sub-circuits 200 having a transistor 201, as shown in FIG. 2, may be such circuits (known as modules), and thus As further shown in 2A, a detection electrode 202, a drive electrode 203, and an amplifier 204 may be included. Both the sensing electrode 202 and the driving electrode 203 are placed on the patient's chest so that they are electrically connected to the patient. The amplifier 204 can 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 detection electrode 202, and the non-inverting input of the amplifier is connected to the bias voltage 205. There is. The amplifier 204 maintains the voltage of the detection electrode 202 at a level close to the bias voltage. The electrocardiogram signal can then be measured with several other electrodes. It is true that the use of some of the anisotropic adhesives mentioned above improves the conductivity, but here, in addition or in substitution, Utilize the third electrode as a proxy for the right foot electrode (ie, a proxy right foot drive electrode that performs the same function as the right foot drive electrode instead of the right foot drive electrode), without it Signal reception, which is not possible, can be realized. Thus, a clean signal allows the reception of cardiac P-waves, which enhances the ability to detect arrhythmias not otherwise detectable.

  A further description of the circuit includes that shown in FIGS. 2B and 2C, which show several alternative aspects that do not limit the scope of the invention. In another aspect, three electrodes E1, E2 and E3 adjacent to each other can be used to pick up an electrocardiogram signal, one of which electrodes is a conventional electrocardiogram monitor ( It plays the role of a distant limb electrode of the ECG monitor. Since the electrode-patient interface has an associated impedance (Re1 and Re2), the current passing through this interface will cause a voltage difference between the patient and the electrode. The circuit this time can use the detection electrode (E1) to detect the voltage of the patient. Since this exemplary circuit node (node, connection point between elements, node) has a high impedance with respect to the circuit ground (GND, ground point, earth), almost no current is generated through the electrode interface. , Thereby minimizing the amount of voltage drop between the patient and this node. A first of these alternative aspects is a circuit (FIG. 2B) that does not limit the scope of the invention, the circuit further comprising an amplifier (U1), the low impedance output of which is , Is connected to a driving electrode (E2) that is an independent electrode (separate, another electrode, and insulated from the other). The amplifier uses negative feedback to adjust its driving electrode so that the patient voltage (measured by the sensing electrode E1) is equal to the bias voltage (V1). This allows the patient voltage to be effectively maintained at a height equal to the bias voltage, despite the voltage difference between the driving electrode (E2) and the patient. This may 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 Foot Drive)" circuits in at least two respects: the drive electrodes are located on the patient's chest (not on the patient's right foot). Points and electrocardiogram signals are single-ended (one of the amplifier circuits is grounded) (not differential) measurements taken from the third electrode (E3). And points. In the chest-placed example, all electrodes are placed on the patient's chest, so a small device placed on the chest can have all the electrodes needed for electrocardiography. One potential advantage of single-ended measurements is the gain and filtering circuitry (U2 and associated components (FIG. 2C)) of the ECG signal prior to recording (ECG output). What is needed to condition a characteristic is that it requires only a small number of components and, in addition, component tolerance matching. Not very sensitive. 2A, 2B and 2C are examples that do not limit the scope of the invention, which figures are not intended to limit the scope of the claims in the specification, since Other circuits having the following circuit elements can be formed by those of ordinary skill in the art in view of that, and such circuits still depart from the spirit and scope of the claims in the specification. Because not.

  In many embodiments, the system described herein can have other circuits that are operable with the plurality of electrocardiographic electrodes, and thus the system is Can be accompanied by several sensors for the purpose of providing multiple time histories (traces, time recordings, waveforms) that are synchronized with each other. The time history is: i) p-, qrs- and t-waves of the electrocardiogram, ii) oxygen saturation measured by pulse oximetry and / or iii ) Xyz acceleration for providing an index of physical activity. In some embodiments, the overall system may have a long (or longer) continuous run time, such as 2 weeks, during which time data collection may occur. Some implementations can be designed to achieve as many as 1000 uses or more. Some other aspects may be operable after or during exposure to fluids or moisture, and in some such instances, water resistant, waterproof or It is watertight and, in some cases, remains fully submersible (in low salt water) and fully operational. Some other implementations have high speed data transmission, and in some cases use HS USB to complete data transmission in less than about 90 seconds. Typically, rechargeable batteries can be used.

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

  For the electrocardiogram, ie EKG or ECG, some embodiments may have an input impedance greater than about 10 meg Ω, and some embodiments use a bandwidth of 0.1-48 Hz. And can have a sampling rate of about 256 Hz, and can achieve a resolution of 12 bits. For PPGs and pulse oximeters, actuation is at wavelengths of 660 nm and 940 nm, SpO2 range of about 80-100 (percutaneous arterial oxygen saturation range), 0.05-4.8 Hz bandwidth, 16 Hz sampling. It can be done using rates and 12-bit resolution. For accelerometers, tri-axial measurements can be employed, and in some implementations use a range of plus or minus 2 G, use 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, volume plethysmometer, photoelectric volume plethysmography, volume plethysmogram signal, PPG signal) From the signal, an option may be included to cancel the noise signal that represents the noise by the circuit). A method and circuit for reducing errors in pulse oximetry caused by ambient light are described in text, which is an optional circuit shown in FIG. 2D. . Here, a correlated double sampling method is used to remove the influences of ambient light, dark current of photodetector (photodetector, photodetector, photodetector, photodiode sensor 112c) and flicker noise. Illustrated for use.

  The schematic diagram shown in FIG. 2D may be used first if the noise signal representative of 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 charges proportional to the noise signal to be stored in C1 (C1, the first capacitor having capacitance C1). After that, the switch S1 is opened. At this point, the voltage of C1 is equal to the voltage of the noise signal. Next, the light signal representative of the light is measured. The light source is turned on, the switch S2 is closed, and the charge is allowed to flow in series via C1 and C2 (C2, the second capacitor with capacitance C2). Then switch S2 is opened and the voltage on C2 is held until the next measurement cycle is started if the whole process is repeated.

  If C1 is much larger than C2 (C1 is much larger than C2, capacity C1 is much larger than capacity C2, C1 / C2 is sufficiently larger than 1, C2 / C1 is sufficiently close to 0), Almost all of the voltage (the voltage of the optical signal) will appear in C2, and the voltage of C2 is the noise-free signal (s-free optical signal) (s ) Will match. If C1 cannot be said to be much larger than C2, the voltage on C2 is a combination of the previous value of the voltage on C2 (p) and the noise-free signal, which is linear, ie (C2 * It will be s + C1 * p) / (C1 + C2). This is because the first-order low-pass IIR (IIR, infinite impulse response) discrete-time filter (digital filter) is applied to the signal (the signall, the optical signal). Have an effect). If this filtering effect is not desired, the signal (the signall, the optical signal, voltage) held at C2 is simply (C2 * s) / (C1 + C2) so that the signall , Said optical signal) is measured every cycle, C2 may be discharged to zero the voltage of C2.

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

  Here, some general methodologies may be understood in the context of FIG. 3, but other methodologies may also be used through multiple points of other parts of those disclosed herein and It may be understood as those parts. A flowchart 300 as in FIG. 3 illustrates some of the alternatives, where an initial manuever 301 places the device 100 on a patient. May be. Certainly, this step may include one or more of the alternatives described above for wearing with an adhesive, but the adhesion is shown in FIG. 1D at 113. Whether by using such an adhesive or by using an adhesive such as that of FIGS. 1E, 1F and / or 1G. After that, as shown in the figure, the flow line 311 is used to move, and the data acquisition process 302 is executed. It should be noted that this step can be either continuous or substantially continuous acquisition, intermittent or periodic acquisition, or one or more events at one time or one time or one interval. Is to have data (a one time event collection). This acquisition method depends on the type of data to be acquired and / or on other features or alternatives, and in one example, for an example of an electrocardiogram, a long-term amount of data is desired. And as in some cases of pulse oximetry, for example, a relative single data point, one time or one time of day. Or it may depend on whether it is useful to obtain data representing one or more events in the interval (eg if the saturation point is clearly low, a single saturation point Of note, it is certainly more typical to have comparative data that shows trends over time).

  Then, some alternatives exist in FIG. 3 or flow chart 300, the first alternative (alternative) is the data transmission process 303 following the flow line 312, and this step Is a device and / or system that performs data analysis and / or storage from device 100 (not shown separately in FIG. 3, but a computing device such as that shown in FIG. 4 below). (And the like, etc.) can include performing wireless or wired data communication. Although a plurality of alternatives (alternative, alternatives) branching from this point also appear, the first alternative (alternative, alternatives) is to move to the data analysis processing 304 along the flow line 313, and the processing thereof. Aims to analyze data for determining whether a patient is relatively healthy and / or for diagnosing a patient's illness. Several computing systems, eg, a computer (many forms can be employed, whether portable, personal, mainframe, or otherwise) 4) and the textual description below) can be used for this analysis, although some analysis can be done either on the device 100 itself or inside the device 100 itself. Sufficient intelligence may be incorporated into the electronics component 103 of the device 100 so that it is operable in. One non-limiting example of the scope of the invention is threshold comparison, which is compared to, for example, pulse oximetry. And, in this example, when a low (or perhaps in some example, possibly high) threshold level is reached, an indicator or alarm is all triggered on / by electronic component 103 of device 100. May be done.

  A similar example is considered by the optional alternative flow path 312a, which itself branches into multiple parts 312b and 312c. It is understood that following the flow path 312a, and then in the first example for the flow path 312b, the data transmission process 303 is skipped so that the analysis 304 is performed without substantial data transmission. .. This describes on-board analysis (analysis by device 100, on-site analysis, on-board analysis), for example whether the analysis follows the threshold example above, or In some examples, it may comprise performing a more detailed analysis depending on the amount of intelligence on / inside the electronic component 103. Another perspective is relative to how much transmission (transmission, transmission volume) is involved, even if the transmission process 303 is used. At the level, for analysis at the electronic component 103, from the patient's skin via conductors 108, 109 and / or 110 and a plurality of conductive paths 107, Data is transmitted up to the electronic component unit 103. In some other examples, of course, the transmission may be off-board downloading to other computing resources off-board (eg, off device 100) (eg, FIG. 4). It is possible to have. In some cases, such off-loading of data may allow more sophisticated analysis with more computing power resources. is there.

  The further alternatives can mainly have data storage, and if that data storage is used, the time and place can be Remembered. As with the intelligence, some storage or memory is available within / by the electronic component 103 of the on-board device 100. Or there is no storage or memory. If storage is present, it is made available on device 100, regardless of whether it has a small or large capacity, and then flow paths 312a through 312c achieve data storage 305. It is used to This step may be present prior to transmission or analysis in many cases, but this is not essential (note that for some types of data, multiple flow paths are Together, but not at the same time, in parallel with each other or in series (eg, flow paths 312b and 312c need not be entirely adopted to exclude the other), thereby saving And sending or storing and analyzing are executed without necessarily requesting completion of a specific process before starting the other process or before executing the other process in a mode other than the mode of the start. Can be done). Thus, after (or during) the save 305 is performed, the flow path 315a is subsequently followed for saved data, which is then transferred by the flow path 315b to process 303. , Transmitted, and / or the data is parsed by transitioning to process 304 by flow path 315c. Examples of such storage, which are often also examples of on-board storage, in this example, data is acquired, then the data is stored in local memory and then for analysis. , Robust, robust, disturbance tolerant, structurally stable, off-loaded, to one or more computing resources (eg, FIG. 4) Are forwarded / transmitted to the peripheral device. Frequently, this process can have long-term data retention in the form of, for example, days or weeks or longer periods, and, therefore, the patient can be at the doctor's hospital or otherwise. It is possible to have remote data acquisition when you are away from your healthcare facility. Thus, the data can be obtained from the patient's real-world environment. Then, after the data is acquired, the data is transmitted from the storage on the device 100 to the target computing resource (eg, FIG. 4), and the transmission may be wireless, wired, or a combination thereof, for example, a personal computer. A Bluetooth or Wi-Fi connected to a computer (Fig. 4 for one example), which personal computer then sends the data via the internet for final analysis. , Communicate to the specified computer. Another example has a configuration in which a 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. May be connected to the doctor's computer.

  If the storage or memory on the device 100 is low or absent (or even in some examples, even a large amount of resident memory available), relatively quickly after data acquisition, One or both of transmitting and / or subsequently storing the data may be necessary or desirable, in which case the flow path 313a may be experienced after execution of operation 303 and / or data transmission and parsing may take place, In this case, flow paths 312 and 313 are experienced. If the flow path 313a is used, more typically the data storage described above is inside / of a computing resource (not shown in FIG. 3, but see FIG. 4 below). Overlying computing resources, which are off-board (off-board, outside of device 100) (but on-board (inside of device 100) memory as well. Of the flow paths 315a, 315b and 315c can be used.

  Features of what is described in this specification include an overall system having one or more devices 100 and some computing resources (see, eg, FIG. 4), Whether the computing resource is mounted on the device 100 (on-board device) or separated from the device 100 (separate), in the latter case, for example, personal or A mobile or handheld computing device (schematically shown in Figure 4), the overall system of which allows a doctor or doctor to analyze and publish acquired test data immediately and in-office. Realize the ability to do. This allows, in some embodiments, in-situ data analysis from the device without the use of a third party for data extraction and analysis.

  Some alternatives to those described in the specification may, therefore, selectively combine one or more combinations of hardware and software. It is possible to provide for multiple (alternative, alternative) data source interpretations. As mentioned above, the device 100 herein includes hardware that monitors one or more of various physiological parameters, and then the relevant data, the physiological data. Generate and save something that represents a parameter. Then, a system uses hardware, such as device 100 and / or some components of device 100, and software and computing resources (schematically shown in FIG. 4) to process physiological parameters. I have it. The system not only acquires the data, but also interprets and correlates the data.

  For example, the electrocardiographic time history (trace, trace, chronograph, ECG waveform) showing that ventricular arrhythmias occur during strenuous exercise may differ from the same arrhythmia that occurs during rest ( differently, interpreted as a different event, but differently from the electrocardiogram time histories indicating that the same arrhythmia occurs during rest There is a nature. What is a blood oxygen saturation level that changes significantly with exercise (variably greatly with movement, changes greatly depending on whether you are exercising or resting, and changes significantly depending on the intensity of exercise of the patient) , Especially at rest (conditions), it is possible to show more serious conditions (conditions, symptoms). It is possible to use many combinations of the above four physiological parameters, and if the software has the ability to visualize and highlight potential problems (problems, reasons that may prevent the doctor from making a correct diagnosis), the doctor's diagnosis Can be highly supported. Thus, the system described herein may provide useful data interpretation.

  Among the features described above, those capable of assisting in achieving this end may be incorporated into one or more of processes 303 and 304 of FIG. 3, where: The data acquired on device 100 can be fairly easily stored on a computing device (again, whether onboard device 100 or discrete from device 100, as shown in FIG. 4, for example). It can be sent / sent. For example, if a patient wearing a device (process 301) returns to the physician's office after the examination period for which the data was acquired (process 302), the device may A computer (Windows (registered trademark) or Mac (registered trademark)) in the clinic via one or more alternatives (alternatives) for transmitting, for example, USB (the outline is shown in FIG. 4 and (Described with reference to the detailed description of the invention), which allows immediate analysis by the physician while the patient is waiting (notice that the device 100 is first The device 100 is said to remain attached to the patient until it is removed from the patient or sent and analyzed to determine if more data is desired (pending). That is). In some embodiments, the data analysis time is relatively short, in some embodiments about 15 minutes, and the data analysis is performed in such a manner that the physician can use the analysis software. It may be performed using a GUI (graphic user interface) that is easy for the user to use to guide the doctor.

  An analysis / software package can be arranged to present the test results to the physician in a variety of formats (formats, representation sequences, representations, formats). In some embodiments, an overall overview of test results can be presented along with, or in place of, more detailed results. In each case, a summary of the detected anomalies and / or patient-triggered events (patient-triggered events) is provided as an overall overview. And / or may be provided as part of said more detailed report. Selecting individual anomalies or individual patient-evoked events allows physicians to view additional details, including raw data obtained from the electrocardiograph and / or other sensors Desired flexibility is achieved. According to the package, the data further includes some annotations in an industry standard EHR (EHR, electronic health record, electronic medical record) format. It is also possible to print and save with the above added.

In one embodiment, patient data can be analyzed using software having one or more of the specifications below. Some alternative abilities are:
1. Data acquisition, ie loading data files from the device,
2. Data formatting, that is, conversion of raw data format into an industry standard file format (eg, ECG (xml), DICOM or SCP-ECG) Processing (Note that such data formatting may occur as part of the acquisition, storage or analysis of data, and also the translation, translation from one to another. ) (Eg, the data may be successfully stored in a compressed format that requires transformation or other form of unpacking to perform the parsing),
3. Data storage (whether locally, ie at the clinic / healthcare level, or in the cloud, for example (cloud is optional and offline Reports (presentation, visualization, output) / analysis based on a portable browser running on
4. Analysis, in particular noise filtering (high-pass / low-pass digital filtering) and / or QRS (beat) detection (in some cases for speed and precision) , Having a continuous wave transform (CWT)), and / or
5. Data / analysis report (presentation, visualization, output), one or more Graphical User Interfaces (GUIs), perhaps more specifically an overall summary and / or an overall Statistical summary and / or summary of abnormalities in patient-evoked events;
Strip views of abnormal data by time (incident, time of day, interval, incident) (previous, next), blood oxygen saturation, stress correlation, or the like. view) at another level of detail; and / or allow the caregiver to bookmark / annotate / note notes by time (incident, time, section, incident) It is possible to have and / or have the ability to print.

In addition, regarding multiple alternatives where the hardware is combined into several proprietary software packages, there are:
i) One software package on board the device, which is an electrocardiogram (right foot drive and / or p-wave, qrs-wave and / or t-wave), or oxygen saturation, or xyz acceleration , Configured to store a number of measurements obtained from a plurality of data signals obtained from one or more of those synchronized with each other, whereby a physician Access to the temporal history of the patient (eg, at intervals of 1-2 weeks in some examples), which allows the patient to be present before, during, or after a cardiac event. Those that can be provided with useful information about how active they were.
ii) An alternative for managing the real-time transmission of the real-time measured parameters to a nearby station or relay in real-time. And / or
iii) ECG analysis software that is not installed in the device and that aims to recognize arrhythmia.

  The software described above may be industry-understood software provided by a third party, or generated and transmitted by wearable device 100 and / or received from device 100. Can be specially designed for the data. FDA approval of 510 (k) is desirable throughout testing with standard (MIT-BIH / AHA / NST) arrhythmia database. This type of software uses one or more of automatic ECG analysis and interpretation for ECG signal processing, QRS detection and measurement, QRS feature extraction, normal and ventricular extrasystole classification, heart rate measurement, It can be configured to perform by providing multiple 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. May be configured to be capable of delivering a plurality of measurements, the plurality of measurements being:

Table 1:
1. Minimum, maximum and average heart rate Average value of QRS width 3. Average PR interval 4. Average value of QT interval 5. Mean ST Deviation Further, the software can be configured to recognize a wide variety of arrhythmias, such as:

Table 2A:
1. Sinus rhythm 2. Sinus rhythm + IVCD (intraventricular conduction disorder)
3. Sinus bradycardia 4. Sinus bradycardia + IVCD
5. Tachycardia 6. Pulse stagnation (PAUSE)
7. Unclassifiable rhythm 8. artifact

  The first group of the above eight types of arrhythmias are the types of arrhythmias that can be recognized even when there is no recognizable P wave. They are a type of arrhythmia commonly recognized by some products that already exist in the outpatient monitoring market and what we propose to address.

A second set or group of arrhythmias 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 those arrhythmias, at which time device 100 detects P-waves, as described above. The detection can, of course, depend on, and, for example, whether the intensity of the P-wave is influenced by the placement of the device 100 (placement, placement position, placement state) or the physiological state of the patient. there is a possibility.

Table 2B:
9. Atrial Fibrillation / Atrial Flutter 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. First-degree AV block + sinus tachycardia 14. First-degree AV block + sinus bradycardia 15. Second degree AV block 16. Third-degree AV block 17. Premature atrial contraction 18. Superior ventricular tachycardia 19. Ventricular extrasystole 20.2 consecutive ventricular extrasystole (COUPLET)
21. Ventricular two-stage pulse 22. Ventricular three-stage pulse 23. Inherent ventricular rhythm 24. Ventricular tachycardia 25. Late ventricular tachycardia

  In addition, in some alternative software implementations, some screenshots are the output of the device and are displayed as images on the monitor screen. An example of what is depicted) is shown in FIG. A first alternative of this kind is shown in FIG. 5A, which uses a patch device, such as device 100, for use on the body. It is an example of the screenshot which shows the acquired electrocardiogram and oxygen saturation data. A very clean signal is shown (no filtering or smoothing was done on this data). Multiple p-waves different from each other are also shown (three of which are shown as an example with arrows). P-wave detection can be extremely important for electrocardiographic abnormality detection. The oxygen saturation measured by pulse oximetry is illustrated on the lower graph. This is the data acquired by the device worn on the chest and is acquired in synchronization with the electrocardiogram data described above.

  Another alternative is shown in Figure 5B, which is an example screenshot of the analysis software. This is a sample of ECG data obtained from record 205 of the MIT-BIH arrhythmia database. As analyzed by the analysis system, five abnormal types (added to normal sinus rhythm (NSR)) are visible in the event occurrence summary column (upper left). This column also indicates the number of occurrences of each abnormality, the total duration of each abnormality in the overall ECG, and the ratio of the time each abnormality occurs in the overall ECG. To view some specific instances (instances, cases, situations, scenes) of each anomaly, the user double-clicks on a particular line in the event summary column, as shown in Figure 5C. click.

  As previously introduced, FIG. 5C is an example screenshot showing a specific instance (instance, case, phase, scene) of ventricular tachycardia. An electrocardiogram plot automatically navigates to specific times within the electrocardiogram waveform, marking the beginning and end of the event. More detailed data on this specific event is now given in the Occurrence Details column, which shows that the heart rate, maximum and maximum for the duration of this event. (HR Max) and so on. To display some instances of another anomaly within this ECG, as shown in FIG. 5D, the user must click in the Ventricular Extrasystole (PVC) row in the Event Summary column. Is possible.

  As already introduced, FIG. 5D is an example of a screenshot showing a specific instance (instance, case, phase, scene) of premature ventricular contraction (PVC). This indicates multiple occurrence points of the PVC. The column of start time (upper center) shows all the instances of occurrence points of PVC in this electrocardiogram, and the column lists the start time for each occurrence point. In this case, the user can click on the PVC starting at 00:15:27 (11th occurrence point). The ECG graph automatically moves to that time, thereby displaying and directing multiple PVC instances within the waveform. Since there are three instances of PVC in this time slot, all three occurrences are marked.

  As mentioned above, in one aspect of some of the developmental results described in the specification, an electrocardiogram signal acquired in synchronism with the pulse oximetry signal is particularly useful for pulse oximetry data. In some situations, where the sensor is worn in some noisy areas of the patient, such as the chest, the objective is to reduce noise in the pulse oximetry signal and how much oxygen saturation is It can be used for the purpose of enabling the calculation of the value of or. In some embodiments, this aspect can be accomplished by the following steps, which include (a) a plurality of heart beats, a period between pulses: (B) measuring one or more pulse oximetry signals over a plurality of heartbeats, wherein the electrocardiogram signal and the one or more pulse oximetry signals are one another over a plurality of heartbeats. In a synchronized manner, and (c) of each of the one or more pulse oximetry signals, a constant component and a primary periodic component, a plurality of periodic or alternating components In order to detect (determine, the one having the largest amplitude, the first-order periodic component), a part of the electrocardiogram signal and the one or more pulse oximetry signals are synchronized with each other. And (d) comparing the one or more heartbeats to each other, and (d) the some constant components and some primary periodic components of the one or more pulse oximetry signals. The step of detecting (determining) the oxygen saturation from the periodic component. Measuring electrocardiogram signals and multiple pulse oximetry signals can be performed by some implementations 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 photodetector of the device described herein. Some alternatives may have some other color, for example green, in addition to or in place of one or both of red and infrared. Some such options are detailed below.

  Multiple pulse oximetry signals (intervals, intervals with time widths, intervals, time intervals) of the pulse oximetry signals that correspond to multiple heartbeats are those pulses.・ Detection by comparing the pulse oximetry signals (the pulse oximetry signals) with an electrocardiogram signal synchronized with the pulse oximetry signals (determine) )Is possible. For example (which is not intended to limit the scope of the invention), a plurality of R wave (R wave, QRS wave) peaks that are continuous with each other in the synchronized electrocardiographic signal have the plurality of intervals (intervals). It can be used to identify), but other features of the same electrocardiogram signal can also be used. Once these multiple intervals (interval, interval with time width) are identified (identified, positioned), multiple numerical values measured for these intervals and corresponding to each other between these intervals. Values at corresponding times within the intervals, the same value at a certain time (time or interval) within each interval and relative to the above time within another interval (Numerical values in time) are averaged, thereby reducing signal noise, and the plurality of stationary components (“DC” of the pulse oximetry signals) among the plurality of pulse oximetry signals. Component (sometimes referred to as a DC component)) and the plurality of primary periodic components (those having the largest amplitude among a plurality of periodic components, that is, AC components, first-order periodic components) (“AC component”). (Sometimes referred to as the “AC component”) and more reliable values have been obtained, for example, Warner et al., Anesthesiology, 108: 950-958 (2008). Please refer to. The number of a plurality of signal values recorded in one interval (interval, interval having a time width) depends on the signal sampling rate of the adopted detector and the processing electronic component part. Further, since the plurality of intervals may be different from each other with respect to each duration (duration, time width), the process of averaging and calculating an average value (averaging) is performed by the plurality of intervals (interval, time). It can be applied to a subset (subset), which is a collection of numerical values smaller than a plurality of numerical values existing in the entire interval (width). 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 heartbeats or intervals present in the range over which some of the above averages are calculated may vary significantly, which will be discussed below. In some embodiments, multiple signals obtained from one or more heart beats or one or more intervals can be analyzed, and some alternative embodiments In, it is possible to analyze multiple signals obtained from multiple heart beats or multiple intervals, and in some embodiments, the number of heart beats or intervals ranges from 2 to 25. Within, or within the range of 5 to 20, or within the range of 10 to 20.

  As described above, the method of pulse oximetry (arterial blood oxygen saturation, pulse oximeter, measurement of arterial oxygen saturation) is used to measure several points at the red light wavelength and infrared light wavelength positions. A plethysmogram (photoplethysmogram) signal is measured. The DC component (DC, non-pulsating component) or the average value is estimated and subtracted (subtracted, pulse oximeter signal, PPG signal, original signal, subtracted from each of the two signals, etc.), or , An AC signal, that is, a pulsatile signal (pulsatile signal, the periodic component, the AC component, a non-stationary component, a fluctuation component, a pulsating component) ratio (the ratio of AC, a ratio between two signals relating to the pulsating component, etc.) is estimated. And / or averaged. Linear regression (linear regression analysis) between two signals (the two signals, two pulse oximetry signals, two photoelectric plethysmogram signals, two light waves received by the sensor and having different wavelengths from each other, etc.) ) Can be used as described below. However, there is a limit to the performance (performance achieved by linear regression thereof) due to the presence of noises that are close to each other in both the red light and the infrared light. When the photoplethysmography method using green light (about 550 nm) is adopted, the light is absorbed by blood more than it is absorbed by water or other tissues, so that motion noise, High resistance (resilient, stability) to body movement artifacts, noise due to body movements during exercise of the patient. However, the difference between oxygenated and deoxygenated blood is the difference in the spectrum (the spectrum, spectrum of light, spectrum of electromagnetic waves, etc.) Much less in the green region than in the red region. In another example, the green PPG signal (or red light // or infrared light long time averages, the long time averages for each signal intensity, the length of the data represented by the waveform. (Time average value, time average value)) (described later) may be used for measuring the shape of the pulsatile signal. The weighted average (value obtained by synchronously weighting averaging a plurality of wavelength signals) for any number of wavelengths different from each other (for example, green light, red light and infrared light) is It may be used to estimate the shape of the pulse wave.

  In yet another embodiment, a linear regression algorithm (linear regression algorithm, a method of analyzing the correlation between a plurality of factors using a linear regression equation) is used to measure the 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-type PPG signal may be used. For the first example, the ECG signal may be used to measure a plurality of heartbeat timings (when heart beats occur, times at which a plurality of heartbeats occur, temporal positions at which a plurality of heartbeats occur). The two volume photoplethysmogram signals (the two of the photoplethysmogram signals, the selected two volume pulse wave signals, the two PPG signals, and the sensor receive light according to a plurality of heartbeat positions (positions at which heartbeats occur) , For each of two light waves of different wavelengths, curves 600 and 602 in FIG. 6A, correlating time averaging, of each of the two signals representing the same patient vital sign in time series, It is possible to obtain the average value of the parts synchronized with each other in association with the timing). In that case, a plurality of ensemble averages obtained as a result (the ensemble averages, an average value of the two volume pulse wave signals obtained at each heartbeat occurrence position (the two volume pulse wave signals are synchronized with each other). Corresponding to each other), which are lined up on the time axis, values obtained by synchronously averaging multiple signals, and multiple signals that represent the same patient vital sign in time series. The linear regression method for the average value and the average value between the signals) obtained by sequentially averaging the two signals is applied to the linear gain coefficient (the two signals, the two volume pulse wave signals, etc.). It may be used to determine the linear gain factor). This linear gain factor can be used to measure patient oxygen saturation.

  Alternatively and / or additionally, if a photoplethysmography (PPG) (photoplethysmograph) using green light (about 550 nm) is performed, measure the PPG signal and the shape of the pulsation signal. May be used to This low noise signal is then the independent variable for performing a linear regression on both the red light signal and the infrared light signal (for the linear regression line). In order to compare the linear regression result and the linear regression result for the infrared light signal with each other, they may be used as a common variable). The ratio of the two regression results (two regression coefficients) is an estimated value of the correlation coefficient between the red light signal and the infrared light signal. As described in this document, noise is ensemble averaging over multiple heartbeats, over multiple heartbeats, and multiple time-series representations of the same patient vital sign. It can be reduced by performing averaging performed synchronously between signals, and averaging performed synchronously between a plurality of wavelength signals) (for example, see the description of a plurality of frames below). I want to be). In addition to or instead of using the ECG signal to measure heartbeat timing, a green light wavelength PPG signal may be used. Alternatively, any number of wavelengths that differ from each other (eg, green light, red light and infrared light or red light // or infrared light long time averages, It is also possible to use a weighted average value (a value obtained by synchronously weighting and averaging a plurality of wavelength signals) for a long-time average value of signal strength, a time average value) (described later)). The ensemble averaging may be refined by finding and removing outlier beats, heartbeats that have timing that deviates from the heartbeat as another measure, and finds outlier beats. And the removal is by ignoring heart beats whose correlation to the estimated ensemble average is weaker than the correlation of other heart beats to the estimated ensemble average, or to estimate noise and have strong noise This can be done by giving the heartbeats that emerge from some regions a less weighting factor than other heartbeats. Noise may also be improved by averaging over longer intervals (using the longer average values).

In this sense, the health condition monitoring method included in this document is
Either or both of the user's ECG signal and / or the first photoelectric volume PPG signal and / or a plurality of wavelengths (wavelengths, different wavelengths of the same color, different wavelengths of different colors) are respectively weighted. A step of determining the timing at which each of a plurality of heartbeats appears from a weighted combination (a weighted combination, a signal represented by a time series of ensemble average values for each signal having a plurality of wavelengths, etc.) When,
Envelopes such as the dashed curve 632 and 634 in FIG. 6E, such as the first pulse wave shape template (template, sample of pulse wave shape, sample, pattern) representing the first pulse shape (pulse signal waveform). Line) or data set to generate a time average value of the first photoelectric volume pulse PPG signal,
Calculating the time average value of each of the other two photoelectric volume pulse wave signals in association with the positions of the plurality of heartbeats, wherein one of the other photoelectric volume pulse wave signals is a red light signal, The other photoelectric volume pulse wave signal is an infrared light signal,
Generating a red light signal ensemble average value for the red light signal, and generating an infrared light signal ensemble average value for the infrared light signal,
Comparing each of the red light signal ensemble average values and the infrared light signal ensemble average values with the first pulse wave shape template or data set;
In order to determine a linear gain factor between the two signals, the red light signal and the infrared light signal, the red light signal ensemble average value and the infrared light signal ensemble are determined. A linear regression in the comparison with the first pulse wave shape template or data set, respectively, with an average value (a linear regression, the ensemble average value for the red light signal and the first pulse wave shape template or data set) And a linear regression result between the infrared light signal ensemble mean value and the first pulse wave shape template or data set).
Determining the oxygen saturation of the patient from the linear gain factor.

From a similar perspective, the pulse oxygenation measurement methods (determining pulse oxygenation, pulse oximetry, non-invasive oxygen saturation measurement) included in this document are:
a) Green light is used, or multiple wavelengths (wavelengths, multiple wavelengths different from each other, multiple lights having different wavelengths, light components, electromagnetic waves, electromagnetic wave components, signal components, etc.) are weighted and combined. (a weighted combination) is used to detect a plurality of heartbeats (heart beats, heartbeat timing, heartbeat position),
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, an ensemble average of multiple green lights, both of which are green but have different wavelengths, over and around the same length of time as either red or infrared light Values, ensemble average values for different times of the same wavelength but green light, different ensembles of different frames of the same green light but different wavelength, synchronously averaged multiple green lights thing),
Ensemble averages for multiple wavelengths (wavelengths, different wavelengths, different wavelengths of light, electromagnetic waves or signal light, etc.) that are generally the same length of time as either red or infrared light. (an ensemble average), or the process of using an ensemble average over multiple wavelengths over a length of time that is significantly longer than the length for either red or infrared light ( The ensemble average value can be used to obtain the heartbeat waveform, and the ensemble average value indicates the heartbeat waveform), or
A long time average for a single wavelength having any color (a long time average, average of a plurality of time series data represented by the signal, which exists in a long time section Value, a time average value having a time interval longer than the time interval of the time average value of the red light and infrared light used to measure oxygen saturation, a time average value, etc.).
c) Red pulse shape (pulse shape, pulse wave shape represented by red light signal) template or dataset representing the same pulse wave shape, and infrared pulse wave shape (pulse shape, represented by infrared light signal) (Pulse wave shape) a step of obtaining a template or a data set representing the same pulse wave shape, comparing each of these pulse wave shapes with the first pulse wave shape,
d) A linear regression is used to determine the degree of correlation (correlation coefficient, etc.) between the ensemble average value for red light and the first pulse wave shape template, and the linear regression is used to determine the ensemble average for infrared light. A step of determining a degree of correlation (correlation coefficient, etc.) between the value and the first pulse wave shape template, the ratio of the correlation degrees (correlations, plural correlation coefficients, etc.) It is used as the pulsation component ratio (the AC ratio, an AC (pulsation) component ratio between a plurality of signals such as a red light signal and an infrared light signal) for obtaining the saturation.

  The pulse shape template or dataset is described in this document in that, in some embodiments, the pulse shape template represents a long-term ensemble average value for the PPG signal. It is similar to the reference frame template. However, the difference is that the reference frame template described elsewhere in this document is designed to determine the pulse transit time (pulse transit time, pulse wave velocity, pulse transit time). On the other hand, in the present discussion relating to the first pulse shape, the first pulse shape template or data set, or the like, in order to determine the oxygen saturation, The point is that it is designed.

  The first method is where green light is used for heartbeat detection, but several other methods are equally useful when ECG signals are used for heartbeat detection. In addition, some of the alternatives described above have long-term average values for green or red and infrared light as used for the first pulse shape, and A short time average value for infrared light is used to compare the oxygen saturation with the first pulse wave shape. It may be useful that the long-term averages for the red and infrared light used for the first pulse waveform shape (or data set) are used for the oxygen saturation measurements. It is to be understood that it is associated with relatively short duration signals for the red and infrared light that is captured. Since the shape (pulse wave shape) is expected to change at a slower rate than oxygen saturation, we still use the shorter-term averages to determine the portion of oxygen saturation (and, therefore, more It is possible to use long time averages to determine the shape while obtaining a fast response time.

  It should be noted that green has been found to be desirable due to its high signal-to-noise ratio, where the pulse signal (AC signal, pulse wave signal) is stronger than any other body motion noise that may be present. That's what it means. However, other wavelengths can be used instead 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 , Some colors work well, others do not work well. It should be noted that other colors can be used in the embodiments described in this document even if they do not have the desired signal to noise ratio. Similarly, the fact that red and / or infrared wavelengths have been favorably selected so far means that red and / or infrared is a particular oxygen () of hemoglobin blood in a test subject. It was discovered that the reflectance for oxygenation, contained oxygen, blood oxygen, blood oxygen saturation, etc.) was higher than other light. Each of the blood rich in oxygen reflects more of the effective amount of red light (effective amount, part, the part that is effective as reflected light) than other light, and Blood that does not include is a reflection of an effective amount of infrared light (effective amount, part, a part that is effective as reflected light), and more of the light than other light. It is possible to use light of other colors without any red and infrared light, but other colors of light may have low (or high) effectiveness in some specific applications. Absent. It should be further noted that, as will be appreciated in the art, whenever a light of any particular color is described, multiple discrete wavelengths will fall within such a definition range. It is understood as being inside, and that a utility (utility, utility object, object of interest) may be inside or outside the defined range. It is therefore understood that colors that are neither green nor red nor infrared are used, and / or whether such a color selection (color selection, range of selectable colors, how to select a color). Means that the signal-to-noise ratio and / or the reflectance (reflectiveness) with respect to oxygen content or other utilities (utility, target object, target object) is the minimum practical value. It may only be limited by the requirement of having (minimal effectiveness, minimal effectiveness).

  ECG (electrocardiogram) data or green PPG data (or the like) or long-term average value data of red light // or infrared light is used for two or more volume pulse waves (photoplethysmographs, volume) having different light wavelengths. The pulse wave signal and photoelectric volume pulse wave) may be temporally associated and recorded. The multiple heart beats are detected in an electrocardiogram signal or a green PPG signal. The beats make it possible to define a "frame" of one of the volume pulse wave data during the time between two beats of them that are adjacent to each other. Then, two or more of the multiple frames (these frames, multiple frames for a signal, etc.) are averaged together at each time (at each point in time). It is possible to generate an average frame having the time interval (average of frame durations obtained by the averaging) obtained by the above. Since the volume pulse wave is related to the heartbeat (correlated, time correlated, temporally related, the volume pulse wave timing and the heartbeat timing coincide with each other), the volume pulse wave signal is obtained by the averaging process. Enhanced (reinforced, noise reduced). However, motion artifacts and other noise sources that are not temporally related to heartbeat are also mitigated. Therefore, the signal-to-noise ratio of the one average frame is typically higher than the signal-to-noise ratio of individual frames (time series of a plurality of frames before averaging for the same signal).

  After constructing an average frame for each of at least two plethysmographs (photoplethysmographs, plethysmographic signals, photoelectric plethysmograms) having different optical wavelengths, a linear regression method is performed for each of the two plethysmograms. To estimate the gain (gain, intensity ratio between signals, gain coefficient, linear gain coefficient, etc.) between two average frame signals (the average frames of two signals that are synchronized with each other) Can be used for. The gain value may be used to estimate information about blood oxygen saturation or other components present in the blood, such as hemoglobin, carbon dioxide or the like. For the same purpose, this process may be repeated for additional and / or alternative optical wavelengths.

Some other desirable and / or alternative methods described herein include the red frame signal, a signal that represents the intensity change within a frame of the red light signal, and the infrared frame signal (IR frame signal, a signal indicating an intensity change in a frame of an infrared light signal) and / or a green frame signal (green frame signal, a signal indicating an intensity change in a frame of a green light signal, a green light signal) ) Is present (if / when), the gain between a plurality of specific signals (gain, intensity ratio between signals, such as between red frame signal and infrared frame signal and / or green frame signal, Gain factor, linear gain factor, etc.). In order to obtain them (these, gain), first, the two frames (the original red frame and the infrared frame which are synchronized) are collectively averaging together, at each time. You may average). As a result of this, one signal with reduced noise may be acquired. The gain is
In addition to performing a linear regression method on the red frame signal paired value (combined, the red frame signal and the infrared frame signal or another signal is combined or averaged together, the ensemble average value, etc.) Perform a linear regression method on the signal-pair composite value (combined, an infrared frame signal and a red frame signal or another signal combined or averaged together, the ensemble average value, etc.), and then obtain the result. Obtained by obtaining the ratio between the two values (these two results, the regression coefficient of the red frame signal vs. the combined value and the regression coefficient of the infrared frame signal vs. the combined value), or
A linear regression method is applied to a combined value of red frame signal and green color (combined with green, red frame signal and green frame signal (green PPG signal, green light signal), or an average value of the ensemble, etc.). While executing, infrared frame signal vs. green composite value (combined with green, infrared frame signal and green frame signal (green PPG signal, green light signal) are combined or collectively averaged, the ensemble average value, etc. ), And then two result values (these two results, the regression coefficient of red frame signal vs. green composite value and the regression coefficient of infrared frame signal vs. green composite value) Obtained by obtaining the ratio between, or
The linear regression method is executed for the red frame signal vs. the green frame signal (green, green PPG signal, green light signal), and the linear regression method is executed for the infrared frame signal vs. the green frame signal (green, green PPG signal, green light signal). And then the regression coefficients of the two result values (these two results, red frame signal vs. green frame signal (green, green PPG signal, green light signal)) and infrared frame signal vs. 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 is executed for a combination of green frame signals (green, green PPG signals, green light signals) combined with red frame signals, and green frame signals (green, green PPG signals, green light signals) are infrared frames. The ratio between multiple result values (results, the regression coefficient for the former linear regression and the regression coefficient for the latter linear regression, etc.) obtained as a result of performing the linear regression method on the combined combination of the signals. Is obtained by using.

  Another method is the step of selecting one possible gain value, the candidate gain value being the average frame signal, the average frame of signals having a certain wavelength, two different gain values. Multiplying one of the wavelengths of one of the average frame signal, one of the red frame signal and the infrared frame signal, and another average frame having another wavelength (an average frame, another average frame, red frame signal and infrared) And a residual error (residual error, error, deviation, difference between a product value of the candidate gain value and the average frame and a difference of the other average frame) with respect to the other). This method may be repeated for as many candidate gain values. According to the simple linear regression method (regression model with one explanatory variable), the minimum gain value in the entire area (global) is acquired. It is possible to get multiple minimum values (in local, local, local area). Therefore, if the minimum value of 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 value may be ignored and instead one local minimum value may be chosen.

  Yet another method is to determine the pulse shape for the red light signal and / or the infrared light signal using an ensemble average value calculated over a longer time interval, and then to the pulse wave shape, Fit a signal time-averaged over a shorter time interval (shorter time averaged signals, a signal time-averaged over a time interval shorter than the time interval for the ensemble average). Approximate with a time-averaged signal over the interval). Basically, the Applicant believes that the red light signal or the red light signal or the red light signal or the red light signal instead of the green light signal or the ECG signal described above (such as the time averaged signal over a shorter time period). A long-term average value for the external light signal is used.

  As mentioned above, a wearable device for use on a patient as described herein, which implements the above-mentioned aspects, includes localized skin movements, such as, for example, a chest region. It may be particularly useful for monitoring oxygen saturation to obtain the above-mentioned measurements in some noisy sites, such as those with relatively large values.

  One specific example of the above aspect is shown in FIGS. 6A-6C. In FIG. 6A, a curve A (600) shows an output signal for infrared (IR) reflection from the photodiode of the device, which changes with time, and a curve B (602). Shows the output signal of the device for reflecting red light from the photodiode, which changes with time. In some embodiments, the skin is illuminated by alternating red and infrared LEDs, which produces multiple signals collected by the same photodiode. In FIG. 6B, time synchronized (time synchronized to the pulse oximetry signals of curves A and B above) (ie, time synchronized). Time concordant electrocardiographic data (or alternative / additional green light PPG data or long time averages for red light signals or infrared light signals, as described above), curve C What is shown at (604) has been added to the graph of FIG. 6A. A plurality of peak values (eg peaks 606 and 608) in the electrocardiogram data (or green light PPG data or a long time average value for red light signals or infrared light signals, see above) are pulsed. It can be used to define multiple frames or multiple intervals (intervals, intervals of time) of oximetry data. Another series of frames or intervals is specified by 612 and 614, and further frames can be similarly determined. According to this aspect, pulse oximetry data consisting of multiple frames is collected. The sizes of the plurality of frames (magnitude, number of frames, data size of frame) may vary greatly depending on the specific application. In some embodiments, the number of aggregated frames is in the range of 5 to 25, and in one embodiment, the number of frames is in the range of 8 to 10. Frame. Typically, multiple frames or multiple intervals of pulse oximetry data include multiple signal samples, but different numbers. That is, the output signals from the sensors (the plurality of sensors) can be sampled at a preset rate, such as a rate of taking 32 samples per second. As the length of time that exists between the peaks of the electrocardiogram signal (or long-term averages for green light PPG data or red light signal or infrared light signal) changes, the number of samples per frame changes. In one embodiment, a plurality of features in the electrocardiogram data (or green light PPG data or long-term averages for red light signals or infrared light signals), the starting points of one frame, A plurality of starting points) are associated with the associated peak in the pulse oximetry data (the peak associated with the pulse oximetry data, which is associated with the electrocardiogram at the same time), approximately in the center of the frame. Selected to be the mid-point or center, then a preset number of signal samples are recorded for each frame. In this particular example, preferably the preset number is large enough to ensure that the peak of the pulse oximetry signal is approximately at the mid-frame. To be selected. A plurality of sample values corresponding to a plurality of times (time point, time point, time point, time point) and exceeding the preset value are not used. After the frames of data are collected, the averages of the numbers of the frames at corresponding times are calculated (averages, averages for one frame). The AC component and DC component of the pulse oximetry data are detected from the plurality of average values described above, and then the AC component and DC component are used to calculate the relative oxygen saturation by a conventional method. The conventional method is used as a ratio-of-ratios algorithm, and an example of the algorithm is Cypress Semiconductor document No. 001-26779 Rev A (Jan. 18, 2010). Is. This basic procedure is outlined in the flow chart of Figure 6C. The frame size (in the sense of the number of sample values) is detected (620). The values of multiple samples at corresponding times in each frame are summed (622), and then average values (average values) are calculated for each time. This in turn provides the AC and DC components of the infrared and red and / or green light reflections with reduced noise. In some embodiments, the numerical values for the AC and DC components can be used to calculate oxygen saturation using conventional algorithms (626). Multiple relative values of oxygen saturation (numerical values depending on environmental conditions), for some particular embodiments, multiple absolute values by calibrating the measured 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 atmosphere and oxygen saturation. Multiple measurements are associated with corresponding multiple oxygen levels.

  In addition to the embodiments described above for comparing long-term average values for electrocardiogram (ECG) signals and / or green light PPG or red light signals or infrared light signals with multiple pulse oximetry signals, such comparisons Several other embodiments for doing this are within the purview of those skilled in the art. For example, to find multiple peaks of an AC component of multiple pulse oximetry signals in the presence of noise, which are multiple features of an electrocardiogram signal that are synchronized with the peak of the pulse oximetry signal. To multiple characteristic times (characteristic time, which is a time that is naturally determined by the nature of pulse oximetry) that appears before the value and / or minimum value, and to multiple characteristic times that appear after that. What is present is pulse oximetry if multiple values of pulse oximetry are averaged over multiple heart beats (it is not necessary to average all values of pulse oximetry signal over the multiple heart beats). It can be used to reliably detect peak and minimum values. For example, within one interval, the peak of the R wave (R wave, QRS wave) of a certain electrocardiogram signal appears characteristically, x milliseconds before the maximum value of the pulse oximetry signal. And appears y milliseconds later than the minimum value of the pulse oximetry signal, the essential (essential, intrinsic) information about the AC component of the pulse oximetry signal is a plurality of pulses. It can be obtained by repeating the measurement of only two values of the oximetry signal (two values, two values at two times).

  In some embodiments, multiple numerical values for infrared or red light reflectance measured by the photodiode can be used to estimate the depth and / or velocity of breathing. Is. In FIG. 6D, a curve (630) is shown for a plurality of numerical values for red light, infrared light, and green light that change with time. In FIG. 6E, a plurality of maximum values and a plurality of minimum values of the curve (630) are shown by a broken curve (632) and a broken curve (634), respectively. The difference between the maximum value and the minimum value at a time is associated monotonously with the depth of breath of the individual being monitored. Thus, as shown, the breath at time (636) is shallower than the breath at time (638). In some implementations, the relationship between depth of breath and time can be calculated and monitored in the individual. The curve of the maximum and minimum values (curve 630) representing a plurality of maximum values and a plurality of minimum values which are arranged in time, and the respiratory rate (rate of respiration) over time. It may also be evaluated from the curve 630) consisting of the dashed curves 632 and 634.

  Moving on to the understanding that the respiratory waveform is derived from the R-S amplitude and the R-R interval of the electrocardiogram, the PPG (PPG, plethysmograph, photoplethysmograph) and / or Alternatively, it will be appreciated that a pulse oximeter can be used to estimate the respiratory waveform relatively directly. Since the chest expands and contracts during breathing, the movement of the chest is wandering on the PPG signal (wandering, wobbling, wobbling) baseline (wandering baseline artifact), wandering baseline artifact, Appear as an artifact with a wobbling baseline. In order to focus on the breathing / respiration signal, the PPG data (the PPG data, data representing the PPG signal, volume pulse wave data) is filtered (filter out, filter). The respiration signal (the respiration signal, a signal representing the respiration waveform) may be separated from other components by removing the unnecessary component by. This may be particularly relevant when a PPG (PPG, volume plethysmography, photoplethysmography) is worn on the chest.

  On the other hand, a chest-mounted accelerometer may additionally or alternatively be used to measure the respiratory waveform, especially when the user is on his back. As the chest expands and contracts, its acceleration will rise and fall (or vice versa, or depending on the orientation of the device), which can be measured by an accelerometer.

  Electrocardiogram-based electrocardiogram and / or accelerometer, device and / or method of any of the several above, isolated from each other or combined with each other, and / or described above. It may be used in a state where the respiratory estimation method described above is used. Employing multiple methods may improve accuracy over estimates obtained using a single method, such as estimates, respiratory rate and / or respiratory depth estimates. In that case, the respiratory rate and the respiratory depth may be estimated from the respiratory signal using a time domain method and / or a frequency domain method.

  In some embodiments, the heartbeat timing (eg, obtained from an electrocardiogram signal) and the PPG signal are compared to the pulse wave transit time, ie, the pressure wave from the heart within the human body. It can be used to detect the length of time required to propagate to the site. In that case, the detected value of the pulse wave transit time may be used for detecting or estimating the blood pressure value. It should be noted that the heartbeat timing, electrocardiogram signal and / or PPG signal may be generated using conventional or other multiple methods, systems or devices to be developed in the future, or those signals. May be generated by a wearable device such as the devices described elsewhere in this specification. That is, the algorithms for it may be independently available per se or may be available within a wearable cardiac device.

  As disclosed elsewhere in the specification, the PPG signals for multiple (several) heartbeats, such as a series of PPG signals, may be timed for multiple heartbeats. May be averaged by associating each PPG signal (each, each partial signal, one partial signal) with a corresponding respective heartbeat. As a result, one PPG frame (PPG frame, PPG signal frame) is generated, and in that one PPG frame, the PPG signal associated with the heartbeat is enhanced (reinforced, noise reduced). ) On the other hand, noise not associated with heartbeat is reduced. Furthermore, since the one PPG frame is already associated with the heartbeat timing, the pulse wave transit time is set to one maximum value (peak, maximum value) in order to specify either the start end or the end of the frame itself. Alternatively, it may be estimated by determining the appearance position of any one of the minimum values. This means that the minimum and / or maximum sample (s) of multiple sample values, the minimum of multiple sample values measured by sampling a signal such as an electrocardiogram signal. And / or maximum value), or a plurality of samples measured for the signal (the signal, an electrocardiogram signal, etc.) to determine a plurality of points that are in the middle of the plurality of measured sample values. (Value) may be interpolated and interpolated. For example, the interpolation may be performed using quadratic curve fitting, cubic spline curve fitting, digital filtering interpolation or many other methods.

  The pulse wave transit time may also be estimated by associating the one PPG frame with one sample signal (a sample signal, a sample signal, a reference signal different from the PPG frame). The time shift amount for maximizing the degree of correlation may be determined by shifting the two signals (shifting, moving the signals on the time axis) with respect to each other. If the one sampled signal approximates one expected PPG frame, the time shift amount with the highest degree of correlation may be used to detect the pulse transit time.

  The preferred method or algorithm for those described herein is described in the specification and illustrated in the drawings in FIGS. 7A, 7B and 7C. First, a method 710 of this kind (having or consisting of a portion 710a, a portion 710b and / or a portion 710c) comprises at least one heartbeat (typically an electrocardiogram) signal 712 and at least one For example, as shown in FIG. 7A, the two PPG signals 711 and the input signals are fetched. 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 the heartbeat timing information / signals 712 may be used to generate a plurality of electrocardiogram signals (ie, multiple body parts on the human body). Multiple different leads) to obtain a more accurate estimate of the heartbeat timing information. The PPG signal 711 may use a single lightwave or multiple signals obtained from multiple lightwaves. By using the corresponding heartbeat timing information in association with each PPG signal 711, each PPG signal 711 is divided into a plurality of “frames”, shown in FIG. 7A as PPG frame 1, PPG frame 2 and PPG frame N. In this figure, each frame includes the one PPG signal having a single wavelength and lasting for the duration of one corresponding heartbeat among a plurality of heartbeats. I'm out.

  Optionally, but typically, quality estimation of the PPG signal may also be performed. An example of this process is shown as portion 710b in FIG. 7B. This estimation includes the variance of the PPG signal, an estimate of the signal-to-noise ratio of the PPG signal, the saturation of the PPG signal, patient behavior information obtained from an accelerometer or gyroscope, and noise in the electrocardiogram or impedance measurements. An estimate or other information regarding the PPG signal quality may be considered. FIG. 7B illustrates a good example of using an accelerometer signal 713 used in combination with a PPG signal 711 to generate a PPG signal quality value / estimate 714. This signal quality estimate 714 may then be used in combination with the heartbeat timing information 712 to generate a gain for each frame, and in FIG. 7B the gain for PPG frame 1, the gain for PPG frame 2 and The gain of the PPG frame N is shown, and in this figure, the gain decreases as the signal quality decreases. In order to shorten the calculation time, the signal quality estimation value (the signal quality estimation) 714 may be omitted and a fixed value may be used as the gain information.

  As illustrated in FIG. 7C, a weighted n-point moving average (weighted, n-sample moving-average, weighted n-point moving average frame (one frame has n sample values, and that frame is a weighted moving average). 715) obtained by the above) and the PPG signal that is associated with the heartbeat timing (correlated, temporally associated) is reinforced, while it is not associated with the heartbeat timing ( The gain information (gain of PPG frame 1, gain of PPG frame 2 and gain of PPG frame N quoted from FIG. 7B) is generated in order to generate noise that is uncorrelated. , May be used together with the frame information (PPG frame 1, PPG frame 2 and PPG frame N cited from FIG. 7A) (in FIG. 7C, combined, combination of multiple signals, combination of multiple wavelength signals). Etc.) / Operations (data processing such as manipulated, weighted, averaged, etc.) are performed) .Samples contained in frame (n) (frame (n), weighted n-point moving average frame) 715 The number of values, the number n of sample values used to obtain the average frame 715, may be adapted to reduce noise or response time. The frames are additionally weighted by time, which is the contribution of some frames immediately before or after the current time. The degree may be increased for some frames that are further apart in time and potentially less important, and this additional time weighting may be achieved using IIR or FIR filters. Good.

  Once the average frame 715 has been generated for an instant in time, the pulse wave transit time 716 may be detected by determining the shift amount of the current frame signal relative to the current heartbeat. This is simply the position where the signal (the signal, signal such as PPG signal) indicates the minimum point (minimum, true minimum value, etc.) or the maximum point (maximum, true maximum value, etc.). (index, cue position) 717 may be obtained, and in order to detect the pulse wave transit time 716, the sample index 717 may be compared with the boundary position (heartbeat timing) of the current frame. If a more accurate result is required, an interpolation 716 of the signal (the signal, a plurality of sampled values measured for a signal such as a PPG signal) is performed to determine the minimum value of the signal, It may be done using spline curve fitting or polynomial interpolation in the vicinity of the minimum value, etc.) or the maximum value (the minimum value, the maximum point, etc.) and the minimum point (minimum) ) Or the maximum value can be determined with higher accuracy than the accuracy corresponding to the sampling rate. Finally, a comparison 719 between the current frame and the reference frame template may be performed, in which case the average frame 715 is shifted with respect to the reference frame template. .. The amount of shift with the highest degree of correlation between the average frame 715 and the reference frame template is indicative of the pulse wave transit time 716. This reference frame template may be a preset signal, or the preset signal is adapted by using a long-term useful frame average value with a known pulse transit time. It may be possible to adapt.

  It should be noted that multiple methods of this kind include PPG information and heartbeat timing information, which are non-exclusive including conventional and / or future-developed technologies. Source), or the PPG information and the heartbeat timing information may be obtained separately, alone, together, and / or , A signal representative of signal quality, obtained from a wearable device and / or system as further described in the latter part of the specification (dispersion of PPG signal, signal to noise of PPG signal). Estimated ratio, PPG signal saturation, data obtained from accelerometers or gyroscopes to detect patient behavior, noise estimates in ECG or impedance measurements, or other information about the PPG signal quality) May be acquired with.

  Some further alternatives, whether in the doctor's or doctor's office, for example ICU / CCU (Intensive Care Unit / Intensive Care Unit for Coronary Artery Diseases), are on-site medical care. It is possible to have the data transmission and / or the data interpretation performed with the facility. Accordingly, the device 100 may include various physiological signals that may include electrocardiogram, photoplethysmogram, pulse oximetry, and / or patient acceleration signals. The measure of one or more will be mounted on the patient's chest and held on the chest with an adhesive, as described herein. The device 100 transmits the physiological signals, wirelessly or wired (eg, USB), to a nearby base station for interpretation and further transmission of the physiological signals as needed. To do. The wireless transmission can use Bluetooth (registered trademark), Wi-Fi communication, infrared communication, RFID (radio frequency identification) or another wireless protocol. The device 100 can be powered using wireless induction, batteries or combinations thereof. The device 100 monitors physiological signals and / or obtains data representative of physiological signals. The acquired data can then be transmitted to the nearby base station in real time, wirelessly or by wire. The device 100 can be wirelessly powered by the base station or by a battery so that there are wires between the patient and the station. Is unnecessary.

  Additionally and / or alternatively, the patient or wearer can be monitored wirelessly in a hospital with an ICU (Intensive Care Unit) or other facility. In this sense, the electrocardiogram signal may be measured on the patient using a small, wireless patch device, a device worn on the body and used. The electrocardiogram signal is then digitized and sent wirelessly to the receiver. The receiver restores the received electrocardiogram signal to an analog signal so that it approximately represents the amplitude of the original electrocardiogram signal. The output signal is then sent to the existing hospital ECG monitor via the standard electrode lead. This allows the patient to be monitored using the existing hospital infrastructure without necessarily connecting the patient to the ECG monitor using lead wires. It will be possible. The impedance of the patient's chest may be measured as well, which allows the reconstructed electrocardiogram signal to approximately represent not only the amplitude of the electrocardiogram signal but also the output impedance. This can be used to discover patch devices that are not connected. The output impedance may change continuously, or the output impedance is a plurality of discrete values, one of which may be selected and used (eg to determine a connected device). , One low discrete value, 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 the step of coupling one or more sensors to the infant's forehead. First, the method of acquiring oxygen saturation data by mounting a certain device on the forehead of an infant may be used in the method introduced in the specification. However, an expansion plan or an alternative plan is to attach a plurality of oxygen saturation sensors having appropriate relative positions and a plurality of temperature sensors to one device mounted on the forehead (coupling). May have. The combined data (combined data from multiple sensors) thus obtained is used to determine whether the infant is at risk of asphyxiation due to being prone. It is possible.

  Thus, some of the alternative combinations described in the specification may have one or more of the following elements, and those elements Is 1) an adhesive body having a medical grade (available from many sources suitable), for several days (in some cases, for example, up to 10 days or 2 weeks) selected to have the ability to remain in close contact with the skin without damaging the skin and the operability with the various sensors 2) a conductive electrode or a light-sensitive detector capable of supplying an electrical signal from the skin, or an electrical signal from the photoreaction of skin or subcutaneous tissue to photoexcitation. For 3) amplifiers, microprocessors and memories capable of processing and storing said signals, and 4) for electronic components of those elements. Power source, which is built into the electronic component or has a rechargeability that can be accessed wirelessly, and 5) a flexible circuit, which can be applied to the skin site of interest. It is possible to combine the above-mentioned elements with one another in a flexible strip that is capable of following.

  Examples of multiple physiological parameters that can be monitored, recorded / acquired and / or analyzed can include one or more of the following multiple elements, which are , Electrocardiogram and photoreaction characteristics of the skin excited by light to detect things such as blood oxygen saturation, heart rate and related variability characteristics, and physical activity / And an index representing acceleration. One or more of these components can be used in monitoring outpatients with heart disease for several days and nights, thereby providing post-test analysis. In preparation for this, recording a continuous electrocardiographic signal for several days, together with recording the index values of oxygen saturation and physical exertion (physical exertion by the patient) simultaneously with the electrocardiographic signal. It becomes possible to do it. Similarly, one or more of these factors can be used in monitoring outpatients with pulmonary disease for days and nights, and the purpose of the monitoring. In order to prepare for post-examination analysis, the oxygen saturation is recorded together with the recording of the index value of physical activity at the same time as the oxygen saturation. Alternatively and / or additionally, one or more of these elements may be an inpatient or other subject patient, such as a newborn, a clinic, an emergency room, an ICU. Can be used to monitor wirelessly (or in some cases, wired), and in some cases, electrocardiogram, oxygen and / or physical Detects multiple parameters that represent physical exertion, but instead of storing them, they are wirelessly transmitted to a monitor beside the bed or to a monitor at a central station. It is possible to transmit, thereby freeing the patient from wearing physical wires. In particular, the devices described herein can be worn on the neonatal forehead to monitor respiration and oxygen saturation. In another alternative, the devices described herein can be used to monitor the breathing and electrocardiogram of a patient suffering from the symptoms of sleep apnea.

  Although described herein are exemplary computer systems or computing resources that may be used with the devices described herein, it should be noted that many of the systems and resources for computing are Of the invention are available and operable within reasonably foreseeable ranges, so that the following description is intended to be myriad of numbers properly intended to depart from both the spirit and scope of the invention. It is meant to never limit the computing alternatives that may exist.

  Some of the embodiments of some of the developments described in this specification have various steps. The various steps may be performed by hardware components or embedded within a plurality of machine-executable instructions, which may be a general purpose computer or may use the plurality of instructions. Can be used to cause a specially programmed processor to perform 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, or computer system 400, with which some implementations described herein may be used. According to this example, a sample, such as computer system 400, has a bus 401, at least one processor 402, at least one communication port 403, main memory 404, and removable storage. It is possible to have a medium 405, a ROM (read only memory) 406, and a mass storage (mass storage device) 407. More or less of these elements, whether large or small in number, can be used in particular embodiments.

  The processor 402 can be any known processor, such processor may be, for example, an Intel® Itanium® or Itanium 2® processor, AMD® It is, but is not limited to, a processor called Opteron® or Athlon MP® from Trademarks, Inc., or a processor from multiple product lines of Motorola®. The transmission port 403 is any RS-232 port, 10/100 Ethernet port, Universal Serial Bus (USB) port for dial-up connection using a modem, or a gigabit port using copper or fiber. It is possible to Transmission port 403 is like a local area network (LAN), wide area network (WAN), or other network to which computer system 400 is or is configured to be connected. It can be selected according to various networks.

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

  The mass storage device 407 can be used to store information and commands. For example, a hard disk such as a SCSI drive which is a family product of Adaptec (registered trademark), an optical disk, a disk array such as RAID, a disk such as a RAID drive which is a family product of Adaptec (registered trademark). Arrays or any other mass storage device can be used.

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

  The removable storage medium 405 is an external hard disk drive, floppy (registered trademark) disk drive, IOMEGA (registered trademark) Zip Drive, compact disc ROM (CD-ROM), compact disc. It can be any type of rewritable (CD-RW) or digital video disc ROM (DVD-ROM).

  Some of the above components are meant to exemplify some of the available types. The several examples described above in no way limit the scope of the respective invention, since they are merely illustrative embodiments.

  Some embodiments of each of the present invention particularly relate to devices, systems, methods, media and configurations for monitoring and processing cardiac parameters and data. While one or more embodiments of each of the inventions have been described above in detail, it will be apparent to those skilled in the art that various alternatives, modifications and equivalents exist without departing from the spirit of the invention. It's obvious. Therefore, the above description should not be taken as limiting the scope of the invention, which is defined by the following claims.

Claims (91)

  The methods, devices and / or systems described in this document.   A system or device or method that uses a light pipe having one or more light sources or LEDs and a barrier therein for health monitoring.   A system or device or method using a light pipe having one or more light sources or LEDs and a barrier therein, said barrier being adapted to disperse light in a manner suitable for health monitoring. Or including the arrangement around a plurality of 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 disposed within the light pipe;
A light pipe having one or more light sensors or photodiodes for health monitoring and / or both. A method, device or system according to any of claims 1 to 4, wherein
A light transmitting material having at least one of the one or more light sources or LEDs and a barrier therein;
One or a plurality of optical sensors or photodiodes, and one or both of those arranged in the light transmitting material. A method, device or system for health monitoring according to any of claims 1 to 5, further comprising:
A light-transmitting material or a light pipe enclosing either or both of the one or more light sources and the one or more photosensors. 7. The method, device or system of claim 6, further comprising:
A light-transmitting material or a light pipe, which encloses either or both of the one or more light sources and the one or more light sensors;
The encapsulation is substantially free of air gaps between the light transmissive material or light pipe encapsulant and / or the one or more light sources and / or the one or more optical sensors. The purpose is to improve the efficiency of light emission to the skin and to capture multiple photons that would otherwise be lost (otherwise, in the absence of this technology). And / or both.   8. A method, device or system according to any of claims 1 to 7, further comprising an external barrier (external, another barrier located outside said barrier). 9. The method, device or system of claim 8, wherein
The outer barrier is used for collecting light. A method, device or system according to any of claims 1 to 9,
What uses the above-mentioned light pipe for measurement of contained oxygen (oxygenation). 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 crossing the barrier;
Among the light emitted from the one or more light sources or the LEDs, receiving reflected light is included. The method, device or system of claim 11, further comprising:
Transmitting the light emitted from the one or more light sources and allowing the light to enter the skin of the subject;
Receiving reflected light from the subject,
And measuring one of the oxygen contents contained in the reflected light. A method, device or system according to any of claims 10 to 12, further comprising:
Emitting light to the user's skin by direct emission and / or reflection, and / or both;
Collecting light by receiving and / or reflecting light directly (not through other objects), and
The reflection is performed in a direction away from the barrier or the outer barrier.   A method for measuring oxygen content, comprising 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,
One that uses one or more of red light, infrared light (IR), and green light, or one that uses a plurality of wavelengths that are respectively weighted and combined. 16. A method, device or system according to any of claims 1-15,
The light transmitting material is made of epoxy,
Whether one of the barriers is made of metal and the other is made of metal, one of the barriers is made of synthetic resin, the other barrier is also made of synthetic resin, one barrier is made of metal, the other barrier is made of synthetic resin Or one barrier is made of synthetic resin and the other barrier is made of metal,
The barrier has either or both opacity and diffuse reflectivity for one or more wavelengths of light used;
The light transmissive material has a substantially flat surface;
The thin layer adhesive is adhesively fixed to the surface of the light transmitting material for adhesive fixation to the skin,
That the thin adhesive has a refractive index that is close to that of the light-transmitting material,
Including one or more of substantially no air gaps between the light transmissive body and one or more of the skin, the light source and the sensor. A method of measuring oxygen content, comprising:
A method of using a light pipe having one or more light sources or LEDs and a barrier therein. A method according to any one of claims 1 to 17, wherein
One or more light sources or LEDs are centrally located relative to one or more photosensors or photodiodes, so that the light emitted from said one or more light sources or LEDs is reflected. How to detect light. The method according to any one of claims 1 to 18, wherein
The method wherein one or more photosensors or photodiodes are arranged peripherally relative to one or more light sources or LEDs. 20. A method according to any of claims 1-19, wherein
Two light sources or LEDs are centrally located relative to two or more photosensors;
Four light sources or LEDs are centrally located relative to two or more photosensors;
One or more of four light sources or LEDs being centrally located relative to four or more photosensors,
A method wherein a barrier is disposed between the plurality of photosensors and the plurality of light sources or LEDs. A device for monitoring physiological parameters,
The device is configured to be adhesively fixed to the skin of the subject for monitoring the physiological parameter,
The device is
The substrate,
a) an electrically conductive sensor attached to the substrate, and b) one or more pulse oximetry sensors attached to the substrate, and one or more used for one or more wavelengths. A light source or LED and a combination of the one or more pulse oximetry sensors and a barrier disposed between the one or more light sources or LEDs and / or both. The device of claim 21, wherein
A device in which the one or more light sources or LEDs are centrally located relative to the one or more pulse oximetry sensors. A device as claimed in claim 21 or 22 or including any of the methods, devices or systems of claims 1-20.
The one or more pulse oximetry sensors and / or the one or more light sources or LEDs may be used in a focused or controlled mode for a capillary bed to mitigate local motion artifact effects. A device provided to achieve or controlled, local measurement in a small measurement area. A method of measuring oxygen content, comprising:
A method using one or more centrally located light sources or LEDs. The method of claim 24, wherein
The one or more light sources or LEDs arranged in the center may be provided to one or more photosensors or photodiodes to detect reflected light of the light emitted from the one or more light sources or LEDs. Method that is relatively centrally located. 26. The method of claim 24 or 25, wherein
The method in which one or more photosensors or photodiodes are arranged peripherally relative to the one or more light sources or LEDs. 27. A method according to any of claims 24 to 26, wherein
A method of using red light, infrared light (IR), or green light, or a method in which a plurality of wavelengths are weighted and combined. A method according to any one of claims 24 to 27, wherein
Two light sources or LEDs are centrally located relative to two or more photosensors;
Four light sources or LEDs are centrally located relative to two or more photosensors;
A method in which one or more of four light sources or LEDs are arranged centrally relative to four or more photosensors. A device for monitoring physiological parameters,
The device is configured to be adhesively fixed to the skin of the subject for monitoring the physiological parameter,
The device is
The substrate,
a) a conductive sensor having conductivity that is mounted on the substrate; b) one or more pulse oximetry sensors mounted on the substrate and one or more used for one or more wavelengths. A light source or a combination with an LED, or both,
The device wherein the one or more light sources or LEDs are centrally located relative to the one or more pulse oximetry sensors. A device as claimed in claim 29 or including any of the methods of claims 24 to 28, comprising:
The one or more pulse oximetry sensors and / or the one or more light sources or LEDs are used to reduce a wide area of the capillary bed to reduce local motion artifact effects. , A device that realizes measurement of a larger area than the target area in the focus mode). 31. A device for monitoring physiological parameters according to any of claims 24-30,
The device is configured to be adhesively fixed to the skin of the subject for monitoring the physiological parameter,
The device is
The substrate,
a) a conductive sensor mounted on the substrate, and / or b) a circuit for reducing an error caused by ambient light using a correlated double sampling method, or both. ,
The circuit is
One or more optical sensors,
One or more light sources or LEDs used for one or more wavelengths, arranged centrally 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 located in series with the optical sensor,
The second capacitor is positioned in parallel with the output unit,
A device in which the first switch and the second switch are arranged between the output section and the ground so as to alternately switch between a state of performing output and a state of being short-circuited to the ground. 32. A device, system or method for monitoring a physiological parameter according to any of claims 1-31.
The device is configured to be adhesively fixed to the skin of the subject for monitoring the physiological parameter,
The device is
The substrate,
a) a conductive sensor mounted on the substrate, and / or b) a circuit for reducing an error caused by ambient light using a correlated double sampling method, or both. ,
The circuit is
One or more optical sensors,
One or more light sources or LEDs used for one or more wavelengths;
A barrier disposed 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 located in series with the optical sensor,
The second capacitor is positioned in parallel with the output unit,
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 short-circuited state to the ground. 33. A device, system or method according to claim 31 or 32,
The one or more light sources or LEDs are arranged in the center relatively 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 the other circuit element. A device, system or method according to claim 31, 32, 33 or 34,
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 stored in C1, after which the switch S1 is opened and its At that time, the voltage of C1 is equal to the voltage of the noise signal,
Next, a light signal representative of 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 is opened. The voltage is held until the next measurement cycle is started in case the whole process is repeated,
When C1 is much larger than C2, almost all of the voltage (the voltage of the optical signal) appears in C2, and the voltage of C2 is a noise-free signal which is an optical signal with the noise removed. If it agrees with (s) but C1 is not much larger than C2, the voltage of C2 is a combination of the previous value (p) of the C2 voltage and the noise-free signal and is linear. Something, that is, (C2 * s + C1 * p) / (C1 + C2). 36. The device, system or method of claim 35,
A filtering effect that a first order low pass IIR discrete time filter is applied to the optical signal,
If the filtering effect is not desired, before the optical signal is measured on each cycle, C2 is discharged to zero the voltage on C2 and the optical signal held on C2 becomes (C2 * s) / (C1 + C2). 37. The device according to any of claims 31-36,
A transimpedance amplifier replacing the resistor R,
A phototransistor replacing the optical sensor,
A plurality of FETs replacing the first and second switches;
A device disposed after the output section and employing one or more of 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 the electrocardiogram signal over a plurality of heartbeats,
Measuring one or more pulse oximetry signals over a plurality of heart beats such that the electrocardiogram signal and the one or more pulse oximetry signals are synchronized with each other over one or more heart beats;
A portion of the electrocardiogram signal and the one or more pulse oximetry signals that are synchronized with each other over one or more heart beats are compared to each other, thereby providing the one or more pulse oximetry signals. A comparison step of detecting each of the constant component and the primary periodic component of the signal,
A step of determining oxygen saturation from the stationary component and the main period component of the one or more pulse oximetry signals. 39. The method, device or system of claim 38, wherein
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 is
Defining a plurality of intervals (intervals, temporal intervals) of the pulse oximetry signal based on characteristics of the electrocardiogram signal;
Averaging multiple values of the pulse oximetry signal over the multiple intervals. 41. The method according to any of claims 38-40, wherein
The method in which the stationary component and the main period component of the pulse oximetry signal are determined from the plurality of average values. A method according to any of claims 38 to 41,
The electrocardiogram signal has R wave signals, each of the R wave signals has a peak value for each heartbeat, and the plurality of intervals are determined by focusing on the plurality of peak values of the R wave signal. How to be done. A method according to any of claims 38 to 42, wherein
The method wherein the electrocardiogram signal and the pulse oximetry signal are measured from the chest position of the individual. 44. A device, system or method according to any of claims 1-43,
Includes 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 electrically conductive portion applied adjacent to the at least one sensor,
The wearable monitoring device further comprises a signal effectiveness ratio of the at least one sensor when the at least one sensor receives the signal with reduced noise. ) Includes an adapting unit that adapts to improve
The matching part includes a convex lens. The device of claim 44, wherein
The convex lens is arranged so as to be in operable contact with the wearer's or user's skin (operatively, in a state capable of exchanging signals between the skin and the convex lens, and capable of mutual cooperation). Device designed to be. The device of claim 44 or 45, wherein
The convex lens is operable with respect to the wearer's or user's skin at the same position as the wearer's or user's forehead or chest or in the vicinity thereof (operative, signal between the skin and the convex lens). Devices that are designed to be placed in contact with each other and in a state where they can interact with each other. 47. The device according to any of claims 44-46,
The device in which the convex lens is an enclosure. 48. The device according to any of claims 44 to 47,
The convex lens encapsulant is a device encapsulating the at least one sensor. 49. The device according to any of claims 44 to 48,
The enclosure that becomes the convex lens encloses the at least one sensor, and is operable with respect to the at least one sensor (operatively, in a state where signals can be exchanged between the sensor and the convex lens, Devices that are in contact with each other and do not allow 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 that includes one or a plurality of LEDs, and the enclosure that serves as the convex lens encloses the one or a plurality of LEDs. A device according to any of claims 44 to 50,
The encapsulant serving as the convex lens encloses the one or more LEDs, and at least one of the one or more LEDs is operable (signal between the LED and the convex lens is operative). Contactable, interoperable) such that there is an air gap at the interface between the at least one of the one or more LEDs and the enclosure. A device that does not allow that. 52. The device according to any of claims 44 to 51,
The device wherein the convex lens is one or more of transparent, colorless, made of silicone, and made of medical grade silicone. 53. The device according to any of claims 44 to 52,
The adaptation unit is a device used for pulse oximetry. 54. The device according to any of claims 44 to 53, further comprising:
A device including one or more functional features including one or more of an EKG (electrocardiogram) measurement, a PPG (plethysmograph) measurement, and a wearer acceleration measurement. 55. The device of any of claims 44-54, further comprising:
A device including one or more functional features including either or both of a DRL circuit and a proxy DRL circuit. 56. The device of any of claims 44-55, further comprising:
A device comprising an electrode for a DRL circuit or an electrode for a proxy DRL circuit worn on the chest of the wearer or on the forehead of the wearer. The device of claim 56, wherein
The adapting portion is a recessed contact surface with respect to the skin of the wearer or the user, and in an operable state (operative, in a state where signals can be exchanged between the skin and the adapting portion, A device that is arranged and configured to remain in contact with each other (in an interoperable manner). 58. The device according to any of claims 44 to 57,
Do not disturb the LED light waves emitted from the LEDs from traveling through the device to reach the wearer's or user's skin and the LED light waves from entering the wearer's or user's skin. Device to do. The device of claim 58, wherein
Of the LED light waves emitted from the LED, the reflected light from the skin of the wearer or user proceeds through the device to reach the at least one sensor, the reflected light passing through the device. A device that does not disturb things. 60. A device according to any of claims 44 to 59,
Made using medical grade silicone,
The silicone is one of substantially transparent, substantially colorless, substantially soft, substantially low durometer, and tacky gel or A device having a plurality or having a plurality of high-tack adhesives embedded on both sides of the silicone. The device of claim 60, wherein
With the silicone having a double-sided adhesive,
The lens, conforming (fitting) to either or both of the electronic sensor (the electronic sensor, the at least one sensor) and the skin, and
A device in which motion artifacts are reduced and / or reduced by limiting movement on the interface between the skin, the lens and the sensor. 62. The device according to claim 60 or 61, wherein
The lens is specially configured to have a ridge and be captured between multiple layers that make up a composite adhesive strip (composite adhesive strip) of the wearable monitoring device,
The ridge has the same size as the size of the rectangular opening in the composite adhesive strip, allowing the lens to project slightly from the patient-side surface of the composite adhesive stripe. Device to do. 63. A device, system or method according to any of claims 1 to 62,
Has a lens for the health sensor to detect health,
The lens is configured for operative contact with the wearer's or user's skin in an operative manner (operable, capable of exchanging signals between the lens and skin, and interoperable). In addition, it is configured to realize non-interfering optical pipe transmission in which energy waves are transmitted in the light pipe in a non-interfering state (without interfering with other energy waves). 64. A method of generating one or more of a pulse shape template or a data set representing a pulse shape by using the method, system or device of any of claims 1-63.
Green light wavelength,
An ensemble average value for green light that spans generally the same length of time as either red or infrared light,
Ensemble average over multiple wavelengths that is generally over the same length of time as either red or infrared light, or ensemble average over multiple wavelengths as red or infrared A method comprising using a length of time that is greater than the length of time for any of the light. 65. A method of performing pulsed oxygenation measurements by using the method, system or device of any of claims 1-64.
A generating step of generating one or more of a first pulse wave shape template or a data set representing the first pulse wave shape,
The generation process is
Green light wavelength,
The ensemble average value for green light over a time length that is generally the same as the time length for either red or infrared light,
Ensemble averages for multiple wavelengths over a time length that is generally the same as the time length for either red or infrared light, or a plurality of time lengths longer than the time length for either red or infrared light. Using the ensemble average value for the wavelength of, or
A method comprising using a long time average (time average value of data represented by a waveform) for one wavelength having an arbitrary color. 66. A method of performing determining pulse oxygenation using the method, system or device of any of claims 1-65.
a) Electrocardiogram (ECG) signals are used, green light wavelengths or different wavelengths are used, or a plurality of wavelengths (wavelengths, a plurality of signals having different wavelengths) are respectively weighted and combined. By using one, a detection process of detecting a plurality of heartbeats (heart beats, heartbeat timing, heartbeat position),
b) a generating step of generating one or more of the first pulse wave shape template or the data set representing the first pulse wave shape,
Green light wavelength,
An ensemble average value for green light that spans generally the same length of time as either red or infrared light,
Ensemble averages over multiple wavelengths that generally span the same length of time as either red or infrared light, or ensemble averages over multiple wavelengths for red or infrared Using a length of time greater than the length of time for any of the light, or
Including a step of using a long time average (time average value of data represented by a waveform) for one wavelength having an arbitrary color,
c) An acquisition step of acquiring a red pulse wave shape template or a data set representing the same pulse wave shape and an infrared pulse wave shape template or a data set representing the same pulse wave shape, each of the pulse wave shapes being acquired. To compare with the first pulse wave shape,
d) A linear regression is used to determine the degree of correlation between the ensemble mean value for red light and the first pulse wave shape template, and a linear regression is used to determine the ensemble mean value for infrared light and the first pulse wave shape template. In the determination step of determining the degree of correlation with the pulse wave shape template, the ratio of those degrees of correlation is then the pulsation component ratio for determining the oxygen saturation (the AC ratio, red light, infrared light, etc. Used as the AC (pulsation) component ratio between a plurality of lights of the above).   67. The method of any of claims 1-66, wherein colors other than green, red and infrared are used.   68. The method of claim 67, wherein the choice of color is limited only by the requirement that either the signal to noise ratio and / or the reflectivity for contained oxygen have a practical minimum performance. 69. A method of monitoring health by using the method or device of any of claims 1-68.
One or both of the user's ECG signal and / or the first photoelectric volume pulse wave PPG signal and / or a plurality of wavelengths (wavelengths, a plurality of signals having different wavelengths) are respectively weighted and combined. From the step of determining the timing at which each of a plurality of heartbeats appears,
Calculating a time average value of the first photoplethysmographic PPG signal to generate a first pulse wave shape template or a data set representing the first pulse wave shape;
Calculating a time average value of each of the other two photoelectric volume pulse signals in association with the positions of the plurality of heartbeats, wherein one of the other two photoelectric volume pulse signals is a red light signal. Yes, the other photoelectric volume pulse wave signal is an infrared light signal,
Generating a red light signal ensemble average value for the red light signal, and generating an infrared light signal ensemble average value for the infrared light signal,
Comparing each of the red light signal ensemble average values and the infrared light signal ensemble average values with the first pulse wave shape template or data set;
An ensemble mean value for the red light signal and the first pulse wave shape template or data set to determine a linear gain coefficient between the two signals, the red light signal and the infrared light signal. Using a linear regression between and the linear regression between the infrared light signal ensemble mean value and the first pulse wave shape template or dataset.
Determining patient oxygen saturation from the linear gain factor.   The first photoelectric plethysmogram PPG signal is weighted with a green light signal, a non-red light signal, a non-infrared light signal and / or a plurality of wavelengths (wavelengths, a plurality of signals having a plurality of mutually different wavelengths). 70. The method of claim 69, which is one or more of an attached and synthesized.   71. The method of claim 69 or 70, wherein the other two optoplethysmographic signals include one or more, some or all, of one of a green light signal, a red light signal and an infrared light signal. The first PPG or ECG data is converted into another photoplethysmogram or another two or more photoplethysmograms (photoplethysmogram data, photoplethysmogram data, photoplethysmogram signals) having different optical wavelengths. Recording in sync with that having
A step of detecting a plurality of heartbeats in the first PPG or ECG data, wherein the plurality of heartbeats are photoplethysmogram data during a time between two heartbeats adjacent to each other among the heartbeats. It is possible to define one frame of
A step of averaging two or more of the plurality of frames of the photoelectric volume pulse wave data collectively at each time point to generate one average frame having a time interval acquired thereby, The photoplethysmograph signal is enhanced by the averaging because the photoplethysmograph is temporally related to the heartbeat, and other body motion artifacts that are not temporally related to the heartbeat are also included. The noise source is also reduced,
Interpreting the signal-to-noise ratio of the one average frame as being higher than the signal-to-noise ratio of the individual frames (a time series of a plurality of frames before averaging);
Using linear regression to estimate the gain between two average frames for two signals for the photoplethysmography;
72. Estimating from the gain value one or more of blood oxygen saturation or other components, including hemoglobin, carbon dioxide or others. the method of.   The plurality of steps may include a plurality of different light values to estimate from the gain value one or more of oxygen saturation or other components of blood, including hemoglobin, carbon dioxide or other. 73. The method of any of claims 1-72, which is repeated for wavelength. 74. A method of using the method or device of any of claims 1-73, wherein
Selecting one candidate gain value;
Multiplying the candidate gain value by an average frame signal (average frame signal, a signal representing an average frame of a signal having a certain wavelength),
A residual error (a difference between the multiplication value and another average frame) with respect to another average frame signal having another wavelength (an average frame, a signal representing an average frame of another signal having another wavelength) And the gain between the red frame signal (red frame signal) and the infrared frame signal (IR frame signal) is calculated as follows. 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 the red light signal / infrared light signal,
One of the green PPG signal or a PPG signal having another color or the red light signal / infrared light signal long time average to generate two frames, or A plurality of steps, incorporating the red frame signal (red frame signal, red light signal) and the infrared frame signal (IR frame signal, infrared light signal) to reflect,
To generate a noise-reduced signal (a signal, red light signal, infrared light signal, etc.), first, averaging the two frames together,
Linear regression between a red light signal and a composite of the red light signal and the green PPG signal, or a red light signal, the red light signal and the red light signal / infrared light signal long-term average value linear regression between (long time average) and a composite of
Linear regression between an infrared light signal and a composite 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 Or a linear regression between a composite of the long time average and the
A linear regression between the red light signal and the green PPG signal, or a linear regression between the red light signal and the red light signal / infrared light signal long time average.
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 Or and or
A green PPG signal or the red light signal / infrared light signal combined with a long time average (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 combined long-time average of the signal (long time average) and the infrared light signal, and
And then obtaining a ratio between two result values, each corresponding to each other.   77. The method of claim 74, performed to determine the depth and / or rate of breathing.   Used by one or more of ECG data, PPG data, pulse oximeter data and / or accelerometer data to determine depth and / or velocity of breathing 76. A method according to claim 74 or 75 which is provided.   77. The method of claim 76, comprising generating a respiratory waveform by using one or more of the ECG data, PPG data, pulse oximeter data and / or accelerometer data.   78. The method according to any of claims 74 to 77, wherein a plurality of numerical values for red light, infrared light or green light which change with time are used.   79. A method according to any of claims 74 to 78, comprising measuring infrared reflected light, red reflected light or green reflected light by means of a photodiode in order to estimate the depth and / or velocity of breathing.   One or both of the maximum and minimum values of a curve or waveform of infrared data, red data or green data are related to the difference between the maximum value and the minimum value by the depth of breathing of the individual being monitored. And / or indicating that, over time, the rate of respiration can be evaluated from curves representing a plurality of maximum values and a plurality of minimum values aligned in time. The method according to any one of 1.   81. The method according to any of claims 74-80, wherein a plurality of PPG signals are used.   81. Generating the plurality of PPG signals as the chest expands and contracts during breathing, the chest movements appear as artifacts with a wobbled baseline on the plurality of PPG signals. The method described in.   83. A method as claimed in claim 81 or 82 including the step of separating the respiratory signal from other components by filtering data representative of the PPG signal to focus on the respiratory signal.   84. The method of any of claims 81-83, wherein the optoplethysmogram is worn on the chest. 85. A device using the method according to any of claims 1 to 84, for obtaining one or more of the plurality of signals,
A wearable health monitoring device comprising a substrate, an electrically conductive sensor attached to the substrate, at least one electrically conductive adhesive and at least one non-conductive adhesive Having a double-sided composite adhesive,
The double-sided composite adhesive is attached to the substrate and the conductive sensor,
The at least one conductive adhesive portion is arranged in contact with the conductive sensor in a state capable of transmitting a signal by conduction,
One of the at least one conductive adhesive part, which is conductively attached to the skin of the subject in order to transmit a signal from the subject to the conductive sensor by conduction. Or devices that employ more than one.   Photoplethysmography and / or accelerometer and / or one or more of the methods are isolated from each other or combined with each other and / or combined with an electrocardiogram-based respiration estimation method 86. The method according to any of claims 74 to 85, which is used in a conditioned state.   87. The method according to any of claims 74 to 86, wherein the accuracy of the estimates (estimates, estimates of depth of breath and / or velocity) is improved by using multiple methods over using a single method. ..   88. A system using the device of claim 87, further comprising a computer.   A device using the method of claim 87 or 88.   90. The device of claim 89 using a wearable health monitoring device.   91. The method of any of claims 74-90, wherein software and computer hardware are used to measure oxygen saturation.

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