Using data from body worn sensor to modify monitored physiological data

Modifying monitored physiological data using data from body-worn sensors

Citation of related application

[0002] This application relies upon priority of US Patent Provisional Application No. 62/866,621, entitled "Data Modification of Monitored Physiological Data Using Body Worn Sensors," filed June 26, 2019.

technical field

[0003] The present invention relates generally to monitoring health-related parameters, and more particularly to the use of sensors such as motion sensors for mounting on a human body and using the sensors to provide information about a person's activity and relative position for correction, adjustment, or otherwise Methods and systems for modifying physiological data. Additionally, the present invention relates to integrating a motion sensor with at least one other sensor using a single wire communication system.

Background technique

[0004] Most monitors measure irregular heartbeats or any other irregular or abnormal physiological activity. An ambulatory electrocardiogram (AECG) that is continuously worn anywhere from 24 hours to a week or more to monitor electrocardiogram (ECG) data. Similarly, blood pressure (BP) monitors are used for hypertension management and cardiac monitoring. The monitor generates an alarm in response to detecting an abnormal condition, which may indicate an emergency or a changing level thereof. However, there are often situations where a sensor detects physiological activity that appears abnormal due to a change in the patient's position or due to the patient's movement, yet the patient is actually healthy and his or her health status is such that the alarm does not necessary. This may be especially true for ambulatory patients. For example, a person using a BP monitor may be exercising when abnormal BP levels are detected. Similarly, an AECG monitor may falsely alarm when the wearer's heartbeat appears abnormal during exercise.

[0005] Even though exercise may skew physiological monitoring, mildly ill patients require activity to accelerate their recovery. Therefore, it may be desirable to be able to monitor their movement over time. Some monitors combine information about different types of physiological data to infer whether the wearer (or patient) of the monitor is experiencing an abnormal health condition. For example, several models of BP monitors from different manufacturers have been developed with the added functionality of irregular heartbeat detection. However, these monitors are also prone to providing false positives when healthy people are exercising. In addition to exercise, false positives may also arise due to other external events, such as, for example, when lifting objects, work, fatigue, and any other type of physical stress when environmental conditions change. Sometimes, even changing posture while sleeping can produce false positives.

[0006] Accordingly, there is a need to combine motion detection information, such as by motion sensors, to enable effective monitoring of physiological data and reduce or eliminate false positives generated by physiological monitors. There is also a need to correlate patient motion and/or location information with any other physiological data that can be monitored continuously, regularly or in real time in order to enhance the reliability and accuracy of physiological data monitors and improve diagnosis. Current physiological monitoring systems, such as AECG monitors, cannot effectively integrate motion detection information. Monitoring systems cannot effectively incorporate motion detectors within existing components without having to introduce circuit level changes or other forms of system related modifications. Therefore, there is a need for a simple method and system that can be seamlessly integrated with existing monitoring systems to increase motion detection capabilities. It is also desirable to combine motion detection information with physiological monitoring information to provide relevant data to the user.

[0007] There are many communication methods in which one electronic device can communicate with another or several other devices over multiple wires. Communication methods are also needed to combine motion sensor data with devices for other purposes in order to minimize group size

cost and equipment required. However, for some designs, it becomes more practical to minimize the number of wires required for communication. Known devices use a single-wire bus for bidirectional communication. A single wire connection for two-way communication can connect two or more devices to each other. A master device is known to be connected to one or more slave devices for data communication, and the slave devices draw power from the master device. There is a need for a system that enables efficient, low cost and reliable communication between a motion detection device and any other physiological monitoring device.

SUMMARY OF THE INVENTION

[0008] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, and these embodiments and aspects thereof are intended to be exemplary and explanatory and not limiting in scope.

[0009] The present disclosure discloses a physiological lead configured to monitor movement of a human and monitor physiological parameters of the human, the physiological lead comprising: a connecting wire having a first end and an opposing second end; a connector plug, which attached to a first end, wherein the connector plug is configured to electrically connect the physiological lead with the physiological monitoring system; a socket at the second end, wherein the socket is configured to attach to a person; a motion detector integrated in the socket , wherein the motion detector is configured to acquire the position and motion information of the person and transmit the position and motion information through the connecting lead; and the physiological sensor integrated in the socket, wherein the physiological sensor is configured to obtain the physiological data of the person and transmit the information through the connecting lead transmitting the physiological data, wherein the physiological data includes ECG data, respiration data, SpO₂at least one of data or blood pressure data.

[0010] Optionally, the connecting wires are further adapted to conduct power to the motion detector and transmit data to and from the motion detector.

[0011] Optionally, the physiological sensor includes electrodes configured to detect electrical signals generated by a person's cardiac activity. The electrodes may be partially exposed outside the socket. The electrodes may be configured to transmit electrical signals generated by the activity of the person's heart through the connecting wires. Optionally, the electrodes are positioned adjacent to the motion detector, and the motion detector includes a printed circuit board having integrated therein a power converter, a processor, a comparator, and a three-axis accelerometer, a three-axis accelerometer, and A combination of a gyroscope, or at least one of a three-axis accelerometer, a combination of a gyroscope and a magnetometer.

The present invention also discloses a kind of electrocardiogram monitoring system, it is configured to monitor the movement of the person and monitor the electrical signal generated by the human heart, this electrocardiogram monitoring system comprises: the monitoring device, it is configured to receive the data indicating the electrical signal and data indicative of movement of a person, wherein the monitoring device includes at least two ports; a first electrocardiogram lead having a first end and a second end, the first end having a first end configured to be connected to either of the at least two ends a connector having a receptacle at a second end, wherein the receptacle is configured to attach to a person, and wherein the receptacle includes electrodes and does not include a motion detector; and a second ECG lead having a first end and a second end, the first one end has a connector configured to connect to either of the at least two ports and a second end has a socket, wherein the socket is configured to attach to a person, wherein the socket includes electrodes and a motion detector, and wherein the motion The detector is configured to acquire position and motion information of the person and transmit the position and motion information through the second electrocardiogram lead.

[0013] Optionally, the second ECG lead is further adapted to direct power to the motion detector and transmit data to and from the motion detector.

optionally, in the first ECG lead, the electrode is partially exposed through the socket, configured to detect an electrical signal, and in electrical communication with the first ECG lead, and in the second ECG lead, the electrode is partially exposed through the socket, is configured to detect the electrical signal and is in electrical communication with the first electrocardiogram lead.

[0015] Optionally, in the second ECG lead, the electrodes are positioned adjacent to the motion detector, and the motion detector includes a printed circuit board having integrated therein a power converter, a processor, a comparator, and three-axis acceleration

at least one of a combination of a 3-axis accelerometer, a gyroscope, and a gyroscope, or a combination of a 3-axis accelerometer, a gyroscope, and a magnetometer.

[0016] Optionally, the monitoring device includes a third end . Optionally, the ECG monitoring system further includes a third ECG lead having a first end and a second end, the first end having a connector configured to connect to either of the at least two ports or to the third port, the Both ends have a socket, wherein the socket is configured to attach to a person, and wherein the socket includes electrodes and does not include a motion detector. Optionally, the monitoring device includes a fourth end . Optionally, the ECG monitoring system further includes a fourth ECG lead having a first end and a second end, the first end having a lead configured to connect to any of the at least two ports, the third port or the fourth port. A connector having a receptacle at the second end, wherein the receptacle is configured to attach to a person, and wherein the receptacle includes electrodes and does not include a motion detector. Each of the at least two ports, the third port and the fourth port may be structurally equivalent and configured to receive the same shaped connector.

The present invention also discloses a respiration monitoring system configured to monitor movement of a person and monitor electrical signals generated by respiration of the person, the respiration monitoring system comprising: a monitoring device configured to receive data indicative of the electrical signal and data indicative of movement of a person, wherein the monitoring device includes at least two ports; a first lead having a first end and a second end, the first end having a connection configured to connect to either of the at least two ports a device having a receptacle at a second end, wherein the receptacle is configured to attach to a person, and wherein the receptacle includes a respiration sensor and does not include a motion detector; and a second wire having a first end and a second end, the first end having a connector configured to connect to either of the at least two ends, the second end having a socket, wherein the socket is configured to attach to a person, wherein the socket includes a respiration sensor and a motion detector, and wherein the motion The detector is configured to acquire position and motion information of the person and transmit the position and motion information through the second wire.

[0018] Optionally, the second conductor is further adapted to conduct power to the motion detector and transmit data to and from the motion detector.

The present also discloses a kind of oxygen saturation monitoring system, it is configured to monitor the movement of people and monitor the electrical signal that is generated by the oxygen saturation of people, this oxygen saturation monitoring system comprises: monitoring device, it is configured to receive data indicative of electrical signals and data indicative of movement of a person, wherein the monitoring device includes at least two ports; a first wire having a first end and a second end, the first end having a configuration configured to connect to the at least two ends The connector of any of D, the second end having a receptacle, wherein the receptacle is configured to attach to a person, and wherein the receptacle includes a blood oxygen sensor and does not include a motion detector; and a second wire having a first end and a second end, the first end having a connector configured to connect to either of the at least two ends, the second end having a socket, wherein the socket is configured to be attached to a person, wherein the socket includes a blood oxygen sensor and a motion detector, and wherein the motion detector is configured to acquire position and motion information of the person and transmit the position and motion information through the second wire.

[0020] Optionally, the second conductor is further adapted to conduct power to the motion detector and transmit data to and from the motion detector.

The present disclosure also discloses a method for monitoring movement of a person and electrical signals generated by a person's heart, the method comprising: acquiring a monitoring device configured to receive data indicative of the electrical signal and an electrical signal indicative of the person. motion data, wherein the monitoring device includes at least two ports; connecting a first electrocardiogram lead to any of the at least two ports, wherein the first electrocardiogram lead includes a first end and a second end, the first end having a connector configured to connect to any of the at least two ports, the second end having a socket, wherein the socket is configured to be attached to a person, and wherein the socket includes electrodes and does not include a motion detector; the first electrocardiogram an electrode of the lead is attached to the person; connecting a second ECG lead to any of the at least two ports, wherein the second ECG lead has a first end and a second end, the first end having a configuration

a connector connected to either of the at least two ports, the second end having a socket, wherein the socket is configured to be attached to a person, wherein the socket includes electrodes and a motion detector, and wherein the motion detector is configured to acquiring position and motion information of the person and transmitting the position and motion information through a second ECG lead; attaching electrodes of the second ECG lead to the person; activating a monitoring device; and recording data indicative of electrical signals and data indicative of motion of the person .

[0022] Optionally, the second electrocardiogram lead is further adapted to direct power to the motion detector and transmit data to and from the motion detector.

Optionally, in the second ECG lead, the electrodes are positioned adjacent to the motion detector, and wherein the motion detector includes a printed circuit board having integrated therein the power converter, the processor, the comparator and at least one of a three-axis accelerometer, a combination of a three-axis accelerometer and a gyroscope, or a combination of a three-axis accelerometer, a gyroscope, and a magnetometer.

Optionally, the method further comprises connecting a third electrocardiogram lead to any one of the at least two ports or a third port, wherein the third electrocardiogram lead has a first end and a second end, the first end having a connector configured to connect to either of the at least two ports or a third port, the second end having a socket, wherein the socket is configured to attach to a person, wherein the socket includes electrodes and does not include a motion detector, And the method also includes attaching electrodes of the third electrocardiogram lead to the person. Optionally, the method further includes connecting a fourth electrocardiogram lead to any one of the at least two ports, the third port or the fourth port, wherein the fourth electrocardiogram lead has a first end and a second end, the first the end has a connector configured to connect to either of the at least two ends, the third port or the fourth port, the second end has a socket, wherein the socket is configured to be attached to a person, wherein the socket includes electrodes and A motion detector is not included, and the method further includes attaching electrodes of a fourth electrocardiogram lead to the person. Each of the at least two ports, the third port and the fourth port may be structurally equivalent and configured to receive the same shaped connector.

The present invention also discloses a physiological monitoring system for a wearer of the monitoring system, the physiological monitoring system comprising: at least one connecting lead, wherein each connecting lead comprises: a plug located at a first end of the connecting lead a socket at the second end of the connecting wire, wherein the first end is opposite the second end of the connecting wire; and a motion sensor system proximate the socket, wherein the motion sensor system senses the position and motion information of the wearer , and send this information over connecting wires; wherein the connecting wires provide a power channel to power the motion sensor system and communicate data to and from the motion sensor system.

[0026] Optionally, the plug includes an interface for connection to a power source.

[0027] Optionally, the plug includes an interface to the data storage and processing system.

[0028] Optionally, the receptacle is a snap connector receptacle that attaches to the wearer's body.

[0029] Optionally, the socket is snap-attached to the wearer's body similar to electrocardiogram (ECG) leads. The plug can interface with the physiological monitoring device. The physiological monitoring device may be an ECG monitoring device.

[0030] Optionally, the motion sensor system includes: at least one motion sensor for detecting position and motion information; and a processor for receiving and processing the detected information. The motion sensor may include a triaxial accelerometer; a combination of a triaxial accelerometer and a gyroscope; and at least one of a combination of a triaxial accelerometer, a gyroscope, and a magnetometer. The motion sensor may include a tilt detector. The motion sensor can be configured to provide an indication of motion in all directions. The motion sensor can be configured to provide angular indications on both axes.

[0031] Optionally, the motion sensor system transmits data to and from at least one other physiological monitoring device. The at least one other physiological monitoring device may be an ECG monitoring device, a breathing monitoring device, a blood pressure (BP) monitoring device, or two or more of an ECG monitoring device, a breathing monitoring device, and a blood pressure (BP) monitoring device

multiple combinations.

The present invention also discloses a physiological monitoring system for a wearer of the monitoring system, the physiological monitoring system comprising: at least one connecting lead, wherein each connecting lead comprises: a plug located at a first end of the connecting lead a socket at the second end of the connecting wire, wherein the first end is opposite the second end of the connecting wire; and a motion sensor system proximate the socket, wherein the motion sensor system senses the position and motion information of the wearer , and send this information over connecting wires; wherein the connecting wires provide a power channel to power the motion sensor system and communicate data to and from the motion sensor system.

[0033] Optionally, the plug includes an interface for connecting to a power source. Optionally, the plug includes an interface for connecting with the data storage and processing system.

[0034] Optionally, the socket is a snap connector socket that attaches to the wearer's body. Optionally, the socket is snap-attached to the wearer's body similar to electrocardiogram (ECG) leads.

[0035] Optionally, the plug is docked with the physiological monitoring device. The physiological monitoring device may be an ECG monitoring device.

[0036] Optionally, the motion sensor system includes: at least one motion sensor for detecting position and motion information; and a processor for receiving and processing the detected information. The motion sensor may include a triaxial accelerometer; a combination of a triaxial accelerometer and a gyroscope; and at least one of a combination of a triaxial accelerometer, a gyroscope, and a magnetometer. The motion sensor may include a tilt detector. The motion sensor can be configured to provide an indication of motion in all directions.

[0037] The motion sensor may be configured to provide an indication of the angle in both axes.

[0038] Optionally, the motion sensor system transmits data to and from at least one other physiological monitoring device. The at least one other physiological monitoring device may be an ECG monitoring device, a breathing monitoring device, a blood pressure (BP) monitoring device, or a combination of two or more of an ECG monitoring device, a breathing monitoring device, and a blood pressure (BP) monitoring device.

The present invention also discloses a physiological monitoring system for a wearer of the monitoring system, the physiological monitoring system comprising: at least one connecting lead, wherein each connecting lead comprises: a plug located at a first end of the connecting lead where the plug is configured to interface with a receptacle on the physiological monitoring system; a housing at a second end of the connecting lead, wherein the first end is opposite the second end of the connecting lead; and movement within the housing A sensor system, wherein the motion sensor system senses position and motion information of the wearer and transmits this information through a connecting wire, wherein the motion sensor system includes a power converter for converting power from a power source. The connecting leads provide a channel for transmitting power from the power supply in the physiological monitoring system to the motion sensor system and sending position and motion information from the motion sensor system.

[0040] Optionally, the socket on the physiological monitoring system is one of a plurality of sockets. The receptacle may be shaped differently from the remainder of the plurality of receptacles, or may be the same as the remainder of the plurality of receptacles.

[0041] The above-described and other embodiments of the present invention will be described in greater depth in the accompanying drawings and detailed description provided below.

Description of drawings

These and other features and advantages of the present invention will be understood because, when considered in conjunction with the accompanying drawings, it will become better understood by reference to the following detailed description, in which:

[0043] FIG. 1A shows a connection wire including a motion sensor according to some embodiments of the present invention;

[0044] FIG. 1B shows an adapter cable connecting the connecting wires of FIG. 1A according to some embodiments of the present invention; [0045] FIG. one

Alternative embodiments of a single connector physiological monitoring device;

1D is a flowchart showing steps of an exemplary process for monitoring both a person's motion and electrical signals generated by a person's heart, according to some embodiments of the present invention;

[0047] FIG. 2 shows an orthogonal view of the socket shown in FIG. 1 according to some embodiments of the present invention;

[0048] FIG. 3A illustrates a first portion of a PCB configured to carry components of the motion sensor system shown in FIG. 2 in accordance with some embodiments of the present invention;

[0049] FIG. 3B illustrates a second portion of a PCB located on a side opposite the side of the first portion configured to carry the components of the motion sensor system shown in FIG. 2, according to some embodiments of the present invention;

[0050] FIG. 4 is a block diagram illustrating components of two devices sharing power and communication over a single wire according to some embodiments of the present invention;

5 is an exemplary analog circuit implementing single-wire communication according to some embodiments of the present invention;

6A shows a sample of data transfer from a first device to a second device using the analog circuit of FIG. 5 in accordance with some embodiments of the present invention;

6B shows a sample of data transfer from a second device to a first device using the analog circuit of FIG. 5 in accordance with some embodiments of the present invention;

[0054] FIG. 7A is a photograph of a plug portion of a wire according to some embodiments of the present invention;

[0055] FIG. 7B is a line drawing of the plug portion of the wire shown in FIG. 7A, including a cross-sectional view of its housing;

[0056] FIG. 7c is a schematic diagram of the plug portion of the wire shown in FIG. 7A, and dimensions of its components;

[0057] FIG. 8A shows a top view of a receptacle portion of a wire according to some embodiments of the present invention;

[0058] FIG. 8B shows a side view of the receptacle portion of the wire shown in FIG. 8A;

[0059] FIG. 8c shows a cross-sectional side view of the receptacle portion of the wire shown in FIG. 8A; and

[0060] FIG. 8D shows a bottom view of the receptacle portion of the wire shown in FIG. 8A.

detailed description

[0061] In various embodiments, methods and systems are provided for seamlessly integrating motion detection systems with existing physiological monitoring systems. The motion detection system monitors changes in the position and/or motion of the wearer of the physiological monitoring system. The monitored changes can be correlated with other physiological monitoring data to identify physiological abnormalities and help improve diagnosis. The single-wire communication system enables interfacing between position and/or motion sensing devices and existing or conventional physiological monitors.

[0062] Embodiments of the present provide a motion sensor system that can be embedded within a connecting wire having the form and structure of an ECG lead. The connecting lead is compatible with monitoring devices such as ECG monitoring devices. This connection lead is similar to and connected to a physiological monitoring device in addition to other ECG leads that measure cardiac signals. The connecting leads are used to provide power to the motion sensor system integrated in the distal body of the ECG lead and to support bidirectional communication between the motion sensor system and the monitoring device. In an alternative embodiment, the connection lead with the motion sensor system is also compatible with any other physiological monitoring device in addition to the ECG monitoring device. In embodiments, motion sensor information is combined with information from one or more other physiological sensors to identify abnormalities and improve diagnosis.

[0063] The present relates to a number of embodiments. The following disclosure is provided to enable those of ordinary skill in the art to practice the present invention. The language used herein should not be construed as a general disclaimer of any particular embodiment, nor should it be used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Furthermore, the used

The terminology and phraseology are for the purpose of describing example embodiments and should not be regarded as limiting. Therefore, the present invention is to be accorded the broadest scope so as to encompass numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For the purpose of clarity, details related to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the invention.

[0064] In this application and in the claims, each of the words "comprising", "comprising" and "having" and their forms are not necessarily limited to the member of the list with which the word is associated. It is noted herein that any feature or component described in connection with a particular embodiment can be used and implemented with any other embodiment unless expressly stated otherwise. [0065] Embodiments of the present provide a connection lead that can be connected to a physiological monitoring device, such as an ECG monitor, also referred to herein as an ECG device or an ECG monitoring device. Embodiments of connecting wires are described below with reference to FIGS. 4 , 5 , 6A and 6B. In one embodiment, an ECG device is a system that senses and analyzes ECG signals by recording the electrical activity of the heart. Monitoring is performed over a period of time using electrodes placed on the skin of a subject/person (eg, a patient or other individual). In embodiments, a human is a patient or any other organism under observation monitored by the system of the present. ECG devices are typically interfaced with electrodes via connecting leads (ECG leads). The lead includes an attachment mechanism at one end (proximal end) for connection to electrodes positioned on the subject's skin. The opposite end (distal end) of the lead includes a plug that interfaces with the ECG device. The electrophysiological patterns of depolarization and repolarization of the myocardium were measured and expressed as a curve of voltage versus time. Observation in the form of a line graph (electrocardiogram). The electrocardiogram can be viewed on a screen attached to the ECG device, and/or can be printed on paper. [0066] A portable ECG device uses a small monitoring device worn by the subject that uses wireless communication to transmit monitoring data from the device to a remote monitoring station. The device itself records, analyzes and transmits ECG data. The hardware components in the device implement the sensing and storage, while the software elements implement the processing of the data.

[0067] Sometimes hemodynamic monitoring is performed concurrently with cardiac monitoring. Hemodynamic monitoring is typically performed using hydraulic circuits that monitor blood flow characteristics. Some monitors combine respiratory monitoring with ECG monitoring and/or hemodynamic monitoring or blood pressure (BP) monitoring alone. The respiration monitoring device indicates respiration data such as respiration rate, amplitude, and other characteristics. Most of these and other physiological monitoring devices receive data about their target, but also tend to receive noise that may arise due to the movement of the subject. When combined with other physiological monitoring data, motion data provides key diagnostic information about a subject. [0068] Embodiments of the present may be configured to interface with an ECG device, a respiration monitoring device, a BP monitoring device, any other physiological monitoring device, or a combination of two or more of these devices. For example, these embodiments can be used to wear a non-invasive BP (NIBP) cuff or SpO₂sensor for the patient. Motion information derived from the present embodiment will be used to inform the collected NIBP or SpO₂The data provides more context, such as whether the patient was sitting upright or moving while reading. Although some embodiments of the present system are described in the context of an ECG device (since the system is similarly attached to ECG electrodes and can be attached to monitors in the same manner as ECG leads, such as by combiner (yoke) cables or directly attached to the monitor), but the present system does not rely on any of the ECG components to operate. Embodiments of the present provide a low cost, portable option to additionally monitor a subject's position and motion related data over a single wire for power and data, and combine motion data with other physiological data for improved medical diagnosis and determination of health or fitness level.

[0069] FIG. 1A shows a connection lead 102 including a motion sensing system in accordance with some embodiments of the present invention. The lead 102 has two opposite ends, including a connector/plug 104 at a first end (distal end) and a receptacle 106 at a second end (proximal end). In one implementation, the plug 104 is similar to the plug of the ECG lead 108 and is therefore compatible with conventional ECG monitors. Additionally, the plug 104 may interface with the device 110 . In one embodiment, the device 110 is an ECG device, and the plug 104 connects to the ECG device in a manner similar to how the ECG leads 108 interface with the device 110 . Therefore, the present invention relates to a

The terminal has a lead wire of a connector, the connector is connected to the connection end of a conventional ECG monitoring device, the connection port of a conventional respiration monitoring device, a conventional SpO₂The connection port of the monitoring device or the connection port of the conventional BP monitoring device is compatible, so that the connector is similar in structure to the connector of the conventional ECG lead, the connector of the conventional respiration sensor, the conventional SpO₂Neither the sensor's connector nor the conventional blood pressure cuff's connector has a motion sensor integrated into it.

[0070] According to an embodiment of the present, the electrocardiogram monitoring system of FIG. 1A is configured to monitor movement of a person and to monitor electrical signals generated by the person's heart. ECG monitoring device 110 receives data indicative of electrical signals from one or more ECG leads, including but not limited to lead 108 and motion sensor lead 102 . Additionally, motion sensor leads 102 provide data indicative of the person's motion. Device 110 includes a plurality of ports 120 , at least one of which is for connection to motion sensor lead 102 . A socket 106 at the second (proximal) end of the motion sensor lead 102 is attached to the patient and includes electrodes and motion detectors to obtain position and motion information of the patient and transmit this information through the motion sensor lead 102 . One or more other remaining ports 120 on device 110 are connected to one or more leads 108 that do not include motion detectors.

[0071] In one implementation, the receptacle 106 is configured like a snap-attach receptacle for the ECG leads 108. Snap connectors, also known as spring clip connectors, can be attached to a subject's body. The subject may be a patient, or any other person who is the wearer of the monitoring system and will be monitored by various embodiments of the present. The socket 106 may use ECG adhesive snaps as a means of attachment to the patient's body. In an embodiment, the location or placement of the receptacle 106 on the patient's body is independent of the placement of any ECG electrodes. In some embodiments, the patient is advised of the best location for placing the socket 106, which allows for better detection of respiratory activity (for validating respiratory data or for signaling dyspnea or stress).

[0072] In one embodiment, an ECG adhesive pad is used to attach the socket 106 to the subject. In various embodiments, the receptacle 106 is configured in a manner similar to any type of ECG electrode connector, such as, but not limited to, a wire dumbbell connector, a locking slot connector, or a keyhole connector. In an embodiment, at least one motion sensor system is embedded near the socket 106 and preferably within the housing of the socket 106 . In one embodiment, the housing at the second end of the lead 102 includes a motion sensor within the socket 106 . The connection leads 102 are uniquely configured to transmit motion detection data from the receptacle 106 to the plug 104, which may be further recorded and/or processed by separate circuitry within the device 110. The connection leads 102 provide a single path for powering the motion sensing device in the socket 106 and enable bidirectional communication between the motion sensing system and the device 110 . In an embodiment, the data collected by the motion sensor system is related to data from ECG monitors and/or other physiological monitoring systems, such as respiratory data and blood pressure (BP) data.

[0073] In one embodiment, an adapter cable is used to connect multiple motion sensor systems to a physiological monitoring system, such as the device 110 shown in FIG. 1 . The plug portion of the adapter is configured to connect to a particular device 110 and may include any safety features or unique/specialized aspects required to allow the plug 104 to be connected to the leads 102 . A plurality of receptacles are electrically coupled to device 110 through adapter cables, plugs 104 and leads 102 . FIG. 1B shows an adapter cable 112 for connecting a plurality of wires to the device 110 of FIG. 1 in accordance with some embodiments of the present invention. Plug 104 connects to connector 112a of adapter 112, while another connector portion 112b of adapter 112 may be used to connect another wire, such as another motion sensor system. Additionally, FIG. 1C shows an alternate embodiment of the device 110a that includes a separate connector 116 for connecting the plug 104 . In addition to conventional connectors, a connector 116 may be provided for interfacing with the physiological monitoring device 110a. Connector 106 may also mate with adapter 112 to connect with multiple sensors. Thus, the connector includes the first connector portion 112, It is configured to connect to a connector end of a conventional ECG monitoring device, a connection end of a conventional respiration monitoring device, or a connection port of a conventional BP monitoring device, to a lead extending therefrom and split into two or more Prongs, each of which leads to a port (112a, 112b, etc.) of a connector portion configured to receive ECG leads, a cable to a respiration sensor, or a cable to a blood pressure cuff. It should be understood that although FIG. 1A shows two prong connections, there may be 3, 4, 5

, 6, 7, 8, 9, 10, or 100 forks, or any integer increment therein.

[0074] FIG. ID is a flowchart illustrating exemplary process steps for monitoring both a person's motion and electrical signals generated by a person's heart, in accordance with some embodiments of the present invention. A human is a patient or any other organism under observation monitored by the present system. 1A and 1D, in step 152, an individual, doctor or any other care provider serving a person obtains a monitoring device, such as device 110, configured to receive data indicative of an electrical signal and data indicative of a person's movement. Monitoring device 110 includes two or more ports 120 for connecting ECG leads that do not include motion detectors (eg, lead 108 ) and leads 102 that include motion detectors in their respective sockets. Each of the two or more ports 120 of the device 110 is structurally identical and configured to receive the same shaped connector. In step 154, a first ECG lead (eg, lead 108) is connected to the first terminal . In an embodiment, lead 108 does not include a motion detector. The first port may be any of the two or more ports 120 on the device 110 . The first end of lead 108 includes a connector configured to connect to end of device 110 . The second end of lead 108 includes a receptacle configured to attach to a person. The socket includes electrodes and does not include motion detectors. In step 156, the electrodes of the first ECG lead are Attached to a person at an appropriate location on the body. In step 158, a second ECG lead, such as lead 102, is connected to a second port of two or more ports 120 on device 110. The second ECG lead has a first end with a connector, such as a plug 104 , configured to a corresponding end on the device 110 . The second end of lead 102 has a socket, such as socket 106, which includes electrodes and a motion detector, configured to attach to a person. The motion detector is configured to acquire position and motion information of the person and, when activated, transmit the position and motion information to the monitoring device 110 through the second ECG lead (lead 102). Once the device 110 is activated, the leads 102 conduct power to the motion detector and transmit data to and from the motion detector. In step 160, the electrodes of the second ECG lead are attached to the person in a manner similar to any other ECG lead (eg, lead 108). In some embodiments, a third ECG lead is attached to device 110 at a third of the two or more ports 120 . The third ECG lead is similar to the first ECG lead 108 and does not include a motion detector. The socket of the third lead is attached to a person similarly to the first lead 108 . In some embodiments, the fourth ECG lead is attached to the device 110 at a further one of its ports. The fourth ECG lead is similar to the first ECG lead 108 and the third lead, and is and does not include motion detectors. The socket of the fourth lead is attached to a person similarly to the first lead 108 . In step 162, the monitoring device 110 is activated. The monitoring device 110 is activated by enabling a power source to operate the device 110, and optionally by selecting one or more options to activate the device 110 via a user interface such as a button. In step 164, the monitoring device 110 records data indicative of the electrical signal and data indicative of the movement of the person.

[0075] Traditional physiological monitoring devices record and analyze data related to their expected physiological parameters. Integration of real-time physiological data with location and/or motion related data can be more effective in determining physiological changes in a subject. Physiological data may be monitored as a result of changes in the subject's posture or motion.

[0076] FIG. 2 shows an orthogonal view of the receptacle 200 shown in FIG. 1 in accordance with some embodiments of the present invention. The socket 200 includes a housing 206 that encloses the components of the integrated motion sensor system 204 . A lead connector 208 is located at the distal end of the connecting lead 202 within a portion of a housing 206 that interfaces with an electrode connector, similar to an ECG electrode connector, for attaching the receptacle 200 to a subject's body. The motion sensor system 204 may include a number of components placed on a printed circuit board (PCB) and includes elements that detect and process position and motion related data. Accordingly, in one embodiment, the present invention relates to an ECG electrode having a housing, an electrode embedded in the housing and exposed to the outside thereof, and a motion detector integrated in the housing and adjacent to the electrode.

[0077] FIG. 3A shows a first portion 300a of a PCB configured to carry components of the motion sensor system 204 shown in FIG. 2, according to some embodiments of the present invention. FIG. 3B shows a first view of a PCB according to some embodiments of the present invention.

The second portion 300b, which is located on the side opposite the side of the first portion 300a, is configured to carry the components of the motion sensor system 204 shown in FIG. 3A and 3B concurrently, the PCBs (300a, 300b) are configured to be received within the housing of the receptacles of lead-through wires that couple the motion sensor system to a monitoring device, alone or in conjunction with other physiological monitoring devices Motion sensor data is stored and processed in combination with data. In an embodiment, the PCBs (300a, 300b) are sized to fit within the housing of the socket. In one embodiment, the PCBs (300a, 300b) are 0.5 inches long and 0.3 inches wide, with electrical and electronic components on both sides. In some embodiments, the pads 302 on the PCB (300a, 300b) are configured to solder ground and power/communication wires to the PCB (300a, 300b).

[0078] A connection wire may be soldered to one of the electrical pads 302 to enable communication between the PCB (300a, 300b) components and the power supply and physiological data monitoring device. Power from the power source may be transmitted through the connecting wires and received by the power converter 304 . The power converter 304 is configured to reduce the power on the cable to the recommended chip voltage and remove power fluctuations due to signaling to power the electronic components of the PCB (300a, 300b). The processor 306 is configured to process sensor data and facilitate communication to and from the physiological monitoring device. Motion sensor 308 detects position and motion related data and provides this data to processor 306 . In some embodiments, motion sensor 308 is a multi-axis accelerometer. In one embodiment, motion sensor 308 is a three-axis accelerometer. In various implementations, motion sensor 308 may include a "6-axis" sensor (3-axis accelerometer and 3-axis gyroscope) or a "9-axis" sensor (3-axis accelerometer, 3-axis gyroscope, and 3-axis magnetometer) .Sensors are used to provide position and orientation information on 3 axes, which can be used to determine the patient's orientation, for example to determine if the patient is facing down a hallway rather than walking through it. Assume the accelerometer will indicate a straight down value of 1G (due to gravity ), the accelerometer can be used to determine the inclination of the patient. The inclination indicated by the accelerometer Rapid changes in acceleration can show movement of the object, while slow changes in acceleration can indicate changes in inclination (eg, sitting upright or rolling sideways). The motion sensor 308 is configured to detect at least one or more of position, tilt and motion of the object.

Embodiments of the present may be configured to interface with different types of physiological monitoring devices, such as respiration monitoring devices, BP monitoring devices, and devices that monitor a number of physiological parameters, but in each case it is preferred to locate these devices at Inside the housing of a conventional physiological sensor on the patient's body.

[0080] Embodiments of the present are used to monitor exercise data of a subject. Activity levels can be quantified to provide helpful indications about the exercise performed by the subject. For example, the number of footsteps can be monitored. Embodiments of the present may also be used to indicate the type and duration of one or more activities performed by the subject. For example, physiological data is combined with postural information to determine whether a subject is sitting, standing, awake, or asleep for a healthy duration. Similarly, these embodiments can be used to determine the level of inactivity. For example, a bedridden subject is monitored for a duration of inactivity, and an alarm is generated to remind the subject that movement is required to avoid bedsores, or if the subject has died. These embodiments can also be used to detect falls of a subject. These embodiments can also be used to detect movement of an object, which may be unwarranted, unexpected or unhealthy. For example, movement of the subject away from the bed may be detected when the subject should not be leaving alone. These embodiments can also be used to detect rapid movements such as, but not limited to, seizures, tremors, seizures, tremors, rapid breathing due to discomfort, coughing, vomiting and bed rolling.

[0081] Embodiments of the present may combine respiration detection data with motion sensor data to monitor chest motion and detect apnea. Additionally, measurements of breathing characteristics may be suppressed during a healthy exercise regimen. Similarly, when combining BP measurements, monitoring attempts can be cancelled, delayed or retried at a later time if the subject is identified as hyperactive.

[0082] Embodiments of the present help to minimize false ECG ST segment alerts that might otherwise occur due to positional changes. Also, minimize false ECG rhythm alerts due to position changes or due to exercise, such as v-tach (ventricular

tachycardia), v-run (ventricular run) or any other ECG parameter. If the subject has a critical condition, eg, if the heart rate is low and the pulse amplitude decreases, the combination of ECG data, respiration data, BP data, and motion sensor data according to embodiments of the present may detect and issue an appropriate alert.

[0083] Referring now to FIG. 4, a block diagram 400 of two devices connected using a single wire 402 for power and data communication is shown in accordance with some embodiments of the present invention. In an embodiment, device 406 corresponds to device 110 for physiological monitoring (FIG. 1A), and device 408 corresponds to integrated motion sensor system 204 (FIG. 2) placed within receptacle 106 (FIG. 1A). In an embodiment, the first device 406 and the second device 408 are configured as master and slave devices, respectively. Device 406 provides power to device 408 , and the two devices communicate with each other through wire 402 . In some embodiments, multiple slave devices are connected to the first device 406 .

In one embodiment, during normal operation, the first transistor 410 in the first device 406 is non-conductive, allowing power from the power supply to pass through the power module 412, through the second transistor 416, and through the first resistor 414 goes to wire 402, and thus to any connected devices, such as device 408. The first device 406 and the second device 408 each have non-conductive transistors 416 and 418, respectively. The transistor 418 in the second device 408 is generally non-conductive. Accordingly, power provided by device 406 to device 408 through wire 402 flows to power module 422 through diode 420 located between transistor 418 and power module 422 within device 408 . Comparator 424 is configured to receive within device 408 the power transmitted over wire 402 . Comparator 424 compares the input power rail to a reference voltage and outputs a "low" to a receive pin on processor 426 of device 408 .

[0085] In one embodiment, in order to transfer bits from the first device/master 406 to the second device/slave 408, the first transistor 410 is moved to a conducting state, which switches the transistor 416 to a non-conducting state. The side of the first resistor 414 connected to the wire 402 is pulled "low" through the conduction transistor 410 . On the other side of wire 402, in second device 408, comparator 424 senses that the input power goes "low" and switches the receive pin on processor 426 to "high". In some implementations, "low" and "high" represent voltage levels that can be interpreted as binary data by digital circuits. In some implementations, the "high" and "low" states may be reversed, ie designated herein as "low" may be "high" and "high" may be "low". In some implementations, a "low" to "high" transition on the receive pin represents a binary "1". The diode 420 prevents a rapid drop in voltage entering the power module 422 of the second device 408 . When the power supplied to device 408 through its power module 422 begins to draw current from that node, capacitor 428 located between the line connecting resistor 420 and power module 422 and ground provides a small amount of power. The combination of diode 420 and capacitor 428 momentarily minimizes the voltage drop from power module 422 to the power supply.

Once the second device 408 is given a sufficient amount of time for the input from the wire 402 to drop "low", the first device 406 turns the first transistor 410 back into the non-conducting state, which turns the transistor 416 on to a conductive state, allowing a normal amount of current to flow through wire 402 . If the first transistor 410 turns on to a conducting state and then returns to a non-conducting state relatively quickly, the second device 408 records the change as data, but the power supplied to the second device 408 remains constant. The amount of time that transistor 410 changes its state from on to off can be determined based on the amount of current drawn by device 408 , the current leakage back through diode 420 , and the size of capacitor 428 .

[0087] In order for the second device 408 to transmit data bits to the first device 406, the transistor 416, and thus the transistor 418, is turned on by the processor 426 to a conductive state. The input from wire 402 is momentarily pulled "low" through resistor 430 located between the output of wire 402 and transistor 418 of second device 408 . The comparator 432 on the first device 406 senses that the power output through the resistor 414 drops "low" and therefore changes the receive pin on the processor 434 within the first device 406 to "high". After a sufficient amount of time has expired, the processor 426 on the second device 408 cuts off conduction through the transistor 418,

And the wire 402 input to the second device 408 quickly rises back to the power supply level because the input is no longer shorted to ground. The comparator 432 detects that the output voltage goes back to "high" and sets the receive pin on the processor 434 of the first device 406 back to "low".

In an embodiment, during transmission of the second device 408, the resistor 414 on the first device 406 keeps the regulator of the first device 406 (power supply) free during intermittent short circuit events seen on the power line Overcurrent. During these transfers, transistors 416 and 410 are in a conducting state, so any transient short circuit event of wire 402 is detected by power module 412, which causes system 400 to enter an overcurrent state.

[0089] Communication over wire 402 is asynchronous, which means that a device (either first device 406 or second device 408) can initiate communication on wire 402 at any time. Therefore, it is important for each device 406 and 408 to be able to detect possible data collisions. Data collisions may occur when both devices 406 and 408 transmit data at the same time. When a device wishes to transmit data, it enters the transmit state. In this state, it should only detect the receive pin changing state when it has changed the state of the transmit pin of the device processor. If the receive pin changes when the transmit pin has not changed, the processor (434, 426) concludes that it has sensed a collision and signals such an event to the upper layer protocol of the processors 434 and 426 of the system 400. It will be up to the upper layer protocol to initiate any corrective action (usually a compensation for some random amount of time followed by a retry).

[0090] FIG. 5 shows an exemplary circuit 500 in which a system in accordance with some embodiments of the present invention is simulated. In one embodiment, the left side of the circuit 500 is with respect to the device 506 corresponding to the first device 406, as described with reference to FIG. 4 . Similarly, the right side of circuit 500 is with respect to device 508 corresponding to second device 408 of FIG. 4 . Wire 502 (402) connects devices 506 (406) and 508 (408). The components of FIG. 5 correspond to the various components of FIG. 4 and are similarly numbered. For example, transistors 510 and 516 correspond to transistors 410 and 416 of first device 406/506. In alternative embodiments, there may be multiple devices similar to device 508 , which may be connected to device 506 by wire 502 . In an embodiment, the number of devices similar to device 508 that may be connected to device 506 through wire 502 is limited by the power supplied by device 506 and the power consumed by the plurality of devices 508 . Additionally, the number of the plurality of devices 508 is limited by the ability of the protocol to individually address more than a certain number of devices. In one embodiment, up to eight devices 508 are connected to device 506 .

Referring again to Figure 4, connect to V_gateThe voltage supply of "HostProc" simulates the interaction with the processor 434. The rest of the processor 434 is not simulated. Similarly, the voltage supply "DevProc" simulates the interaction of the processor 426 and does not simulate the rest of the processor. Reference 5, resistor "WIreR_1" 540 and capacitor "WireC_1" 542 are used to simulate the parasitic resistance and capacitance of wire 502. Finally, component U5 and associated components C9 to C13 in power supply 512 of first device 506 are optional In some embodiments, the voltage divider and operational amplifier form the comparator portions 524 and 532, respectively, within the devices 508 and 506 of the circuit 500. However, there is no limitation to this portion of the circuit-such as having an internal reference may be used. other circuits of those circuits.

[0092] Figure 6A illustrates the data transfer from the first device 406/506 to the second device 408/508 shown in Figures 4 and 5, according to some embodiments of the present invention. 4 and 5 are also referenced to enhance the description of the graphs. The figure shows the transmission of a value of 0xFFFF (2 sets of 8 bits of 1). The lower graph 602 shows the input provided to the transmit transistor (the transmit pin of transistor 410 of FIG. 4). The middle graph 604 shows the comparator 424/524 op amp input on the second device 408/508, where the line 606 drawn on the graph 604 is the reference voltage. In one embodiment, the reference voltage is between 2.19V and 2.3V. The top graph 608 shows the output of comparator 42/524, which for all practical purposes is the same as the transmitted input. In an exemplary embodiment, these transmissions are simulated at a rate of 100KHz.

[0093] FIG. 6B illustrates a data transfer from the second device 408/508 to the first device 406/506 in response to the data transfer of FIG. 6A, according to some embodiments of the present invention. In the first graph 632, the top trace 634 is shown to the second

Input power rail for regulator 422 of device 408/508. A certain amount of expected dip is seen in trace 632, which occurs as a result of intermittent dips in power input. However, the output of this power supply remains constant at 3.3V (as shown by the lower trace 636 of the graph 632) because the input is above the regulator's drop limit. In some embodiments, a regulator with a low droop value is selected to prevent a slave device (eg, the second device 408/508) from pulling power down into the droop range of its regulator. Alternatively, in some embodiments, a power resistor, such as resistor 414, is adjusted. The second graph 630 shows the current through the resistor 414 . The graph 628 below the graph 630 shows the comparator 432 output of the first device 406/506, which is the same as the input from the devices 406/506 and 408/508. The fourth graph 622 shows the op amp input 624 of the first device 406/506, where the line 626 is the reference input voltage. Graph 618 shows output 620 of comparator 424 . Trace 614 in graph 616 shows the signal and reference input to comparator 424, respectively. Trace 610 in lower graph 612 is the input to transistor 418 of second device 408/508.

[0094] Additionally, care needs to be taken to minimize the pulse width of the transmitted bits and allow sufficient recovery time between transmissions. Therefore, the pulse width of each bit is controlled. The bandwidth (baud rate) driving the transmission can be a factor that controls the pulse width of each bit. Regardless of the baud rate, if the actual data transfer rate is low, the delay in applying the voltage is small. As the transmission rate increases and approaches the full bandwidth (baud rate) of the channel, the delay will deteriorate. In some embodiments, these signals are in the kHz range and the low part of the pulse is minimized. In an embodiment, the pulse width depends on the speed of each processor ( 434 and 426 ) and the current consumption of each device 408 . The size of capacitor 428, the leakage of diode 420 and the drop voltage value of regulator 422 can also affect the pulse width. Equal high and low width pulses between 1 kHz and 100 kHz are easily adjusted without the need for larger or more expensive components.

[0095] FIGS. 7A, 7B and 7c show images of the first end 700 of the wire connecting the first master 406 (FIG. 4) and the second slave 408 (FIG. 4) in accordance with some embodiments of the present invention . The first end 700 is the plug portion of a lead that connects to a physiological monitoring system, such as the device 110 shown in FIG. 1 . FIG. 7A shows a photograph of a plug portion 700 in accordance with some embodiments of the present invention. Figure 7B shows a line drawing of the plug portion 700, including a cross-sectional view of its housing. Figure 7c shows a line drawing of the plug portion 700 and dimensions of its components. 7A, 7B and 7C simultaneously, the plug portion includes a pin 702, It is configured to be placed within a corresponding recess of the physiological monitoring device to provide an electrical connection between the lead and the physiological monitoring device. The tip of pin 702 emerges from a strip of about 0.8 mm connecting the tip of pin 702 to the opposite end of pin 702, the tip extending about 3.9 millimeters (mm) in length and having a diameter of about 2.35 mm, the opposite end Extends approximately 6.7mm in length and is approximately 2.46mm in diameter. At the opposite end, pin 702 is connected to protective housing 704 . The housing 704 contains a switch with electrical components of the wires that provides communication of power and data from and to the physiological monitoring device when the pin is inserted into the physiological monitoring device. The overall length of the plug portion 700 extends approximately 25.9 mm. In an embodiment, the pin portion 700 is inserted into a special pin on the physiological monitoring device or built into a yoke.

[0096] FIGS. 8A-8D illustrate different views of a wire 800 having a plug portion 802 at one end and a receptacle portion 804 at the other end in accordance with some embodiments of the present invention. FIG. 8A shows a top view of the receptacle portion 804 of the wire 800 . FIG. 8B shows a side view of the receptacle portion 804 of the wire 800 . FIG. 8c shows a cross-sectional side view of the receptacle portion 804 of the wire 800. FIG.

[0097] FIG. 8D shows a bottom view of the receptacle portion 804 of the wire 800. In some embodiments, wire 800 includes coaxial cable to avoid crosstalk. In different embodiments, the length of lead 800 is different to suit various applications. For ECG applications, the length of lead 800 is similar to an ECG lead. Similarly, for ECG applications, lead 800 has a bend radius similar to that of ECG leads. In an embodiment, similar forces and techniques as used for insertion and removal of EGG leads are used

The lead 800 is applied and removed using its plug portion 802. The socket portion 804 corresponds to the socket 200 of FIG. 2 and includes a housing 806 that encloses components of the integrated motion sensor system. The lead connector is located at one end of the connecting lead 800 within a portion of the housing 806 that mates with an electrode connector, similar to an ECG electrode connector, for attaching the receptacle portion 804 to the patient's body. As mentioned above, a motion sensor system may include a number of components placed on a printed circuit board (PCB) and include elements that detect and process position and motion related data. In an embodiment, the housing 806 is waterproof. Receptacle portion 804 may be configured as any known and used connector for positioning on an object.

[0098] The above examples are merely illustrative of the many applications of the system of the present invention. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention may be embodied in many other specific forms without departing from the spirit or scope of the invention. Accordingly, the present examples and embodiments are to be regarded as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.