Using data from a body worn sensor to modify monitored physiological data

Using data from body-worn sensors to modify monitored physiological data

Citation of related applications

[0002] This application relies on and takes priority from U.S. Provisional Application No. 62/866,621, filed on June 26, 2019, entitled "Modifying Physiological Data Monitored Using Data from Body-Worn Sensors."

Technical Field

[0003] The present invention generally relates to monitoring health-related parameters, and more particularly to methods and systems for mounting a sensor, such as a motion sensor, on a human body and using the sensor to provide information about the person's activity and relative position in order to correct, adjust or otherwise modify physiological data. In addition, the present invention relates to integrating the motion sensor with at least one other sensor using a single-wire communication system.

Background Art

[0004] Most monitors measure irregular heartbeats or any other irregular or abnormal physiological activity. An ambulatory electrocardiogram (AECG), which is worn anywhere from 24 hours to a week or more continuously, monitors electrocardiogram (ECG) data. Similarly, blood pressure (BP) monitors are used for hypertension management and heart monitoring. The monitor generates an alarm in response to detecting an abnormal condition, which can indicate an emergency or its level of change. However, there are often such situations, that is, when the sensor detects physiological activity that appears abnormal due to changes in the patient's position or due to the patient's movement, the patient is actually healthy and his or her health status makes the alarm unnecessary. This may be especially true for patients who can walk. For example, a person using a BP monitor may be exercising when an abnormal BP level is detected. Similarly, an AECG monitor may mistakenly sound an alarm when the wearer's heartbeat appears abnormal during exercise.

[0005] Even though exercise may skew physiological monitoring, patients with mild symptoms need activity to accelerate their recovery. Therefore, it may be desirable to be able to monitor their movements over a period of 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 additional function of irregular heartbeat detection. However, these monitors are also prone to providing false positives when healthy people are in motion. In addition to exercise, false positives may also be generated due to other external events, such as, for example, any other type of physical stress when lifting objects, working, fatigue, and changes in environmental conditions. Sometimes, even changing posture during sleep may also generate false positives.

[0006] Therefore, there is a need to combine motion detection information, such as by motion sensors, to be able to effectively monitor physiological data and reduce or eliminate false positives generated by physiological monitors. There is also a need to associate the patient's motion and/or position 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 the physiological data monitor and improve diagnosis. Current physiological monitoring systems, such as AECG monitors, are not able to effectively integrate motion detection information. The monitoring system cannot effectively combine 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 the capability of motion detection. 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 through multiple wires. There is also a need for communication methods to combine motion sensor data with devices used for other purposes in order to minimize the combination of

The cost and equipment required for communication are not met. 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 bidirectional communication can connect two or more devices to each other. Known master devices are connected to one or more slave devices for data communication, and the slave devices draw power from the master device. A system is needed 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 which are intended to be exemplary and illustrative, not limiting in scope.

[0009] The present invention discloses a physiological lead, which is configured to monitor the movement of a person and monitor the physiological parameters of the person, and the physiological lead includes: a connecting wire having a first end and an opposite second end; a connector plug attached to the first end, wherein the connector plug is configured to electrically connect the physiological lead to a physiological monitoring system; a socket at the second end, wherein the socket is configured to be attached to a person; a motion detector integrated in the socket, wherein the motion detector is configured to obtain the position and motion information of the person and transmit the position and motion information through the connecting wire; and a physiological sensor integrated in the socket, wherein the physiological sensor is configured to obtain the physiological data of the person and transmit the physiological data through the connecting wire, wherein the physiological data includes ECG data, respiratory data, SpO₂At least one of data or blood pressure data.

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

[0011] Optionally, the physiological sensor includes an electrode configured to detect an electrical signal generated by a person's cardiac activity. The electrode may be partially exposed to the outside of the socket. The electrode may be configured to transmit the electrical signal generated by the person's cardiac activity through a connecting wire. Optionally, the electrode is positioned adjacent to the motion detector, and the motion detector includes a printed circuit board having a power converter, a processor, a 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 integrated therein.

[0012] The present invention also discloses an electrocardiogram monitoring system, which is configured to monitor the movement of a person and to monitor the electrical signals generated by the heart of the person, the electrocardiogram monitoring system comprising: a monitoring device, which is configured to receive data indicating the electrical signals and data indicating the movement of the person, wherein the monitoring device comprises at least two ports; a first electrocardiogram lead, which has a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports, and the second end having a socket, wherein the socket is configured to be attached to the person, and wherein the socket comprises electrodes and does not comprise a motion detector; and a second electrocardiogram lead, which has a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports, and the second end having a socket, wherein the socket is configured to be attached to the person, wherein the socket comprises electrodes and a motion detector, and wherein the motion detector is configured to obtain 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 also adapted to conduct power to the motion detector and transmit data to and from the motion detector.

[0014]Optionally, in the first ECG lead, the electrode is partially exposed through the socket, configured to detect electrical signals, and electrically connected to the first ECG lead, and in the second ECG lead, the electrode is partially exposed through the socket, configured to detect electrical signals, and electrically connected to the first ECG lead.

[0015] Optionally, in the second electrocardiogram lead, the electrode is positioned adjacent to the motion detector, and the motion detector includes a printed circuit board having a power converter, a processor, a comparator, and a three-axis accelerometer integrated therein.

At least one of a combination of a tri-axial accelerometer and a gyroscope, or a combination of a tri-axial accelerometer, a gyroscope, and a magnetometer.

[0016] Optionally, the monitoring device includes a third port. Optionally, the ECG monitoring system also includes a third ECG lead having a first end and a second end, the first end having a connector configured to connect to any one of the at least two ports or the third port, and the second end having a socket, wherein the socket is configured to be attached to a person, and wherein the socket includes an electrode and does not include a motion detector. Optionally, the monitoring device includes a fourth port. Optionally, the ECG monitoring system also includes a fourth ECG lead having a first end and a second end, the first end having a connector configured to connect to any one of the at least two ports, the third port or the fourth port, and the second end having a socket, wherein the socket is configured to be attached to a person, and wherein the socket includes an electrode and does not include a motion detector. Each of the at least two ports, the third port and the fourth port can be structurally equivalent and configured to receive connectors of the same shape.

[0017] The present invention also discloses a respiratory monitoring system, which is configured to monitor the movement of a person and monitor the electrical signals generated by the breathing of the person, the respiratory monitoring system comprising: a monitoring device, which is configured to receive data indicating the electrical signals and data indicating the movement of the person, wherein the monitoring device comprises at least two ports; a first wire, which has a first end and a second end, the first end having a connector configured to be connected to any one 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 comprises a respiratory sensor and does not comprise a motion detector; and a second wire, which has a first end and a second end, the first end having a connector configured to be connected to any one 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 comprises a respiratory sensor and a motion detector, and wherein the motion detector is configured to obtain position and motion information of the person and transmit the position and motion information via the second wire.

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

[0019] The present invention also discloses an oxygen saturation monitoring system, which is configured to monitor the movement of a person and monitor the electrical signal generated by the oxygen saturation of the person, the oxygen saturation monitoring system comprising: a monitoring device, which is configured to receive data indicating the electrical signal and data indicating the movement of the person, wherein the monitoring device comprises at least two ports; a first wire, which has a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports, and the second end having a socket, wherein the socket is configured to be attached to a person, and wherein the socket comprises a blood oxygen sensor and does not comprise a motion detector; and a second wire, which has a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports, and the second end having a socket, wherein the socket is configured to be attached to a person, wherein the socket comprises a blood oxygen sensor and a motion detector, and wherein the motion detector is configured to obtain position and motion information of the person and transmit the position and motion information via the second wire.

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

[0021] The present invention also discloses a method for monitoring the movement of a person and the electrical signals generated by the heart of the person, the method comprising: obtaining a monitoring device, the monitoring device being configured to receive data indicating the electrical signals and data indicating the movement of the person, wherein the monitoring device comprises at least two ports; connecting a first electrocardiogram lead to any one of the at least two ports, wherein the first electrocardiogram lead comprises a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports, and the second end having a socket, wherein the socket is configured to be attached to a person, and wherein the socket comprises electrodes and does not comprise a motion detector; attaching the electrodes of the first electrocardiogram lead to the person; connecting a second electrocardiogram lead to any one of the at least two ports, wherein the second electrocardiogram lead has a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports, and the second end having a socket, wherein the socket is configured to be attached to the person, and wherein the socket comprises electrodes and does not comprise a motion detector; attaching the electrodes of the first electrocardiogram lead to the person; connecting a second electrocardiogram lead to any one of the at least two ports, wherein the second electrocardiogram lead has a first end and a second end, the first end having a connector configured to be connected to any one of the at least two ports

A connector is connected to any one 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 obtain position and motion information of the person and transmit the position and motion information through a second electrocardiogram lead; attach the electrodes of the second electrocardiogram lead to the person; activate the monitoring device; and record data indicative of the electrical signal and data indicative of the person's motion.

[0022] Optionally, the second ECG lead is also adapted to conduct power to the motion detector and transmit data to and from the motion detector.

[0023] Optionally, in the second ECG lead, the electrode is positioned adjacent to a motion detector, and wherein the motion detector includes a printed circuit board having integrated therein a power converter, a processor, a 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.

[0024] Optionally, the method further includes connecting a third electrocardiogram lead to any one of the at least two ports or the third port, wherein the third electrocardiogram lead has a first end and a second end, the first end has a connector configured to be connected to any one of the at least two ports or the third port, the second end has a socket, wherein the socket is configured to be attached to a person, wherein the socket includes an electrode and does not include a motion detector, and the method further includes attaching the electrode 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 end has a connector configured to be connected to any one of the at least two ports, 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 an electrode and does not include a motion detector, and the method further includes attaching the electrode of the fourth electrocardiogram lead to the person. Each of the at least two ports, the third port and the fourth port can be structurally equivalent and configured to receive connectors of the same shape.

[0025] 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 wire, wherein each connecting wire comprises: a plug located at a first end of the connecting wire; a socket located at a second end of the connecting wire, wherein the first end is opposite to the second end of the connecting wire; and a motion sensor system close to the socket, wherein the motion sensor system senses the position and motion information of the wearer and sends the information through the connecting wire; wherein the connecting wire provides a power channel to supply power to the motion sensor system and to communicate data to and from the motion sensor system.

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

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

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

[0029]Optionally, the socket is similar to an EKG(ECG)The lead is snap-fitted to the wearer's body. The plug can interface with a physiological monitoring device. The physiological monitoring device can beECGMonitoring 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 at least one of a three-axis accelerometer; a combination of a three-axis accelerometer and a gyroscope; and a combination of a three-axis accelerometer, a gyroscope, and a magnetometer. The motion sensor may include a tilt detector. The motion sensor may be configured to provide motion indications in all directions. The motion sensor may be configured to provide angle indications on two 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 respiration monitoring device, a blood pressure (BP) monitoring device, or two or more of the ECG monitoring device, the respiration monitoring device, and the blood pressure (BP) monitoring device.

A combination of multiple.

[0032] 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 wire, wherein each connecting wire comprises: a plug located at a first end of the connecting wire; a socket located at a second end of the connecting wire, wherein the first end is opposite to the second end of the connecting wire; and a motion sensor system close to the socket, wherein the motion sensor system senses the position and motion information of the wearer and sends the information through the connecting wire; wherein the connecting wire provides a power channel to power the motion sensor system and to communicate data to and from the motion sensor system.

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

[0034] Optionally, the socket is a snap connector socket attached to the wearer's body. Optionally, the socket is similar to an electrocardiogram (ECG) lead snap-on attachment to the wearer's body.

[0035] Optionally, the plug is docked with a 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 at least one of a three-axis accelerometer; a combination of a three-axis accelerometer and a gyroscope; and a combination of a three-axis accelerometer, a gyroscope, and a magnetometer. The motion sensor may include a tilt detector. The motion sensor may be configured to provide motion indications in all directions.

[0037] The motion sensor can be configured to provide angular indications on two 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 respiration monitoring device, a blood pressure (BP) monitoring device, or a combination of two or more of an ECG monitoring device, a respiration monitoring device, and a blood pressure (BP) monitoring device.

[0039] The present invention also discloses a physiological monitoring system for a wearer of a monitoring system, the physiological monitoring system comprising: at least one connecting wire, wherein each connecting wire comprises: a plug, which is located at the first end of the connecting wire, wherein the plug is configured to dock with a socket on the physiological monitoring system; a shell, which is located at the second end of the connecting wire, wherein the first end is opposite to the second end of the connecting wire; and a motion sensor system in the shell, wherein the motion sensor system senses the position and motion information of the wearer and sends the information through the connecting wire, wherein the motion sensor system includes a power converter for converting power from a power supply. The connecting wire provides 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 shape of the socket may be different from the rest of the plurality of sockets, or may be the same as the rest of the plurality of sockets.

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

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] These and other features and advantages of the present invention will be understood as they become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which:

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

[0044]picture1BA connection diagram showing some embodiments of the present invention1Aadapter cable for connecting leads; [0045]picture1CA single device for interfacing with a motion sensing system is shown according to some embodiments of the present invention.

Alternative embodiments of a physiological monitoring device with a single connector;

[0046]picture1Dis a flow chart illustrating steps of an exemplary process for monitoring both a person's motion and electrical signals generated by the person's heart according to some embodiments of the present invention;

[0047]picture2Figures showing some embodiments of the present invention1an orthogonal view of the socket shown;

3A illustrates a first portion of a PCB configured to carry components of the motion sensor system shown in FIG. 2 , according to some embodiments of the present invention;

3B illustrates a second portion of a PCB, located on a side opposite to the side of the first portion, configured to carry 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 showing components of two devices sharing power and communication over a single conductor according to some embodiments of the present invention;

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

6A illustrates a sample of data transmission from a first device to a second device using the analog circuit of FIG. 5 according to some embodiments of the present invention;

6B illustrates a sample of data transmission from a second device to a first device using the analog circuit of FIG. 5 according to some embodiments of the present invention;

FIG. 7A is a photograph of a plug portion of a lead according to some embodiments of the present invention;

[0055] FIG7B is a line drawing of the plug portion of the lead shown in FIG7A, including a cross-sectional view of the housing thereof;

[0056]picture7cIt is a picture7Aa schematic diagram of the plug portion of the wire shown, and the dimensions of its components;

FIG. 8A illustrates a top view of a socket portion of a lead according to some embodiments of the present invention;

[0058]picture8BThe diagram shows8Aa side view of the socket portion of the wire shown;

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

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

DETAILED DESCRIPTION

[0061]In various embodiments, the present invention provides methods and systems for seamlessly integrating a motion detection system with an existing physiological monitoring system. The motion detection system monitors the position and/or changes in movement. 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/Or the motion sensing device is interfaced with an existing or traditional physiological monitor.

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

[0063] The present invention relates to a plurality of embodiments. The following disclosure is provided to enable one of ordinary skill in the art to practice the present invention. The language used herein should not be interpreted as a general denial 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 present invention. Furthermore, the language used herein should not be construed as a general denial of any particular embodiment, nor should it be used to limit the claims beyond the meaning of the terms used therein.

The terms and expressions are for the purpose of describing exemplary embodiments and should not be considered as limiting. Therefore, the present invention will be given the widest scope, which covers many alternatives, modifications and equivalents consistent with the disclosed principles and features. For the sake of clarity, details related to technical materials known in the technical field related to the present invention are not described in detail, so as not to make the present invention unclear unnecessarily.

[0064] In the present application and in the claims, each of the words "comprises", "includes" and "having" and forms thereof are not necessarily limited to the members of the list with which the word is associated. It should be noted herein that any feature or component described in conjunction with a specific embodiment can be used and implemented with any other embodiment unless otherwise explicitly stated. [0065] The present embodiment provides a connecting lead capable of connecting to a physiological monitoring device, such as an ECG monitor, also referred to herein as an ECG device or ECG monitoring device. The following describes an embodiment of the connecting lead with reference to Figures 4, 5, 6A and 6B. In one embodiment, the ECG device is a system for sensing and analyzing 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 an object/person (e.g., a patient or other individual). In an embodiment, the person is a patient or any other living being under observation monitored by the present system. The ECG device is typically connected to the electrodes via a connecting lead (ECG lead). The lead includes an attachment mechanism at one end (proximal end) for connecting to electrodes positioned on the skin of the subject. The opposite end (distal end) of the lead includes a plug that interfaces with an ECG device. The electrophysiological pattern of depolarization and repolarization of the myocardium is measured and viewed as a graph of voltage versus time (electrocardiogram). The electrocardiogram can be viewed on a screen attached to the ECG device and/or can be printed on paper. [0066] Portable ECG devices use 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 sensing and storage, while the software elements implement the processing of the data.

[0067] Sometimes hemodynamic monitoring is performed simultaneously with cardiac monitoring. Hemodynamic monitoring is often performed using a hydraulic circuit that monitors blood flow characteristics. Some monitors combine respiratory monitoring with ECG monitoring and/or hemodynamic monitoring or just blood pressure (BP) monitoring. Respiratory monitoring devices indicate respiratory data, such as respiratory rate, amplitude, and other characteristics. Most of these and other physiological monitoring devices receive data about their objectives, but also tend to receive noise that may be present due to the subject's motion. When combined with other physiological monitoring data, the motion data provides critical diagnostic information about the subject. [0068] Embodiments of the present invention may be configured to interface with an ECG device, a respiratory 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 may be used to monitor the patient's blood pressure while wearing a non-invasive BP (NIBP) cuff or SpO₂The motion information derived from this embodiment will be used to collectNIBPorSpO₂The data provides more context, such as whether the patient is sitting upright or active at the time of the reading. While some embodiments of the present system are described in the context of an ECG device (because the system similarly attaches to ECG electrodes and can be attached to a monitor in the same manner as ECG leads, such as through a combiner (yoke) cable or directly to the monitor), the present system does not rely on any of the ECG components to operate. Embodiments of the present invention 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 to improve medical diagnosis and determine health or fitness levels.

[0069] FIG. 1A shows a connection lead 102 including a motion sensing system according to some embodiments of the present invention. The lead 102 has two opposing ends, including a connector/plug 104 at a first end (distal end) and a socket 106 at a second end (proximal end). In one implementation, the plug 104 is similar to the plug of an ECG lead 108 and is therefore compatible with a conventional ECG monitor. Additionally, the plug 104 can be docked with a device 110. In one embodiment, the device 110 is an ECG device, and the plug 104 is connected to the ECG device in a manner similar to the docking of the ECG lead 108 with the device 110. Thus, the present invention relates to a method of docking an ECG lead 108 with a device 110.

The end has a connector lead that is compatible with conventionalECGThe connection port of the monitoring device, the connection port of the traditional respiratory monitoring device, the traditionalSpO₂Connection port for monitoring device or conventionalBPThe connection port of the monitoring device is compatible, making the connector similar in structure to the traditionalECGLead wire connector, traditional respiratory sensor connector, traditionalSpO₂The connector of the sensor or the connector of a traditional blood pressure cuff does not have a motion sensor integrated into it.

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

[0071]In one implementation, the socket106Configured similar toECGlead108A snap-on attachment socket. A snap-on connector, also known as a spring clip connector, can be attached to the body of a subject. The subject can be a patient, or any other person who is the wearer of the monitoring system and is to be monitored by various embodiments of the present invention. Socket106Can be usedECGAdhesive snaps are used as a means of attachment to the patient's body. In an embodiment, the socket106The position or placement on the patient's body is independent of anyECGElectrode placement. In some embodiments, the patient is advised to place the socket106This allows for better detection of respiratory activity (for verifying respiratory data or for signaling respiratory distress or stress).

[0072] In one embodiment, an ECG adhesive pad is used to attach the socket 106 to an object. In various embodiments, the socket 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 located within the socket 106. The connecting lead 102 is uniquely configured to transmit motion detection data from the socket 106 to the plug 104, which can be further recorded and/or processed by a separate circuit within the device 110. The connecting lead 102 provides a single path for powering the motion sensing device in the socket 106 and enabling 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 an ECG monitor 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 Figure 1. The plug portion of the adapter is configured to connect to a specific device 110 and may include any safety features or unique/special aspects required to allow the plug 104 to connect to the lead 102. Multiple sockets are electrically connected to the device 110 through the adapter cable, the plug 104 and the lead 102. Figure 1B shows an adapter cable 112 for connecting multiple wires to the device 110 of Figure 1 according to some embodiments of the present invention. The plug 104 is connected to the connector 112a of the adapter 112, and another connector portion 112b of the adapter 112 can be used to connect another wire, such as another motion sensor system. In addition, Figure 1C shows an alternative embodiment of the device 110a, which includes a separate connector 116 for connecting the plug 104. In addition to the traditional connector, a connector 116 can also be provided for docking with the physiological monitoring device 110a. The connector 106 can also dock with the adapter 112 to connect with multiple sensors. Therefore, the connector includes a 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 splitting into two or more prongs, wherein each prong leads to a port (112a, 112b, etc.) configured to receive a connector portion of an ECG lead, a cable connected to a respiration sensor, or a cable connected to a blood pressure cuff. It should be understood that although FIG. 1A shows a two-prong connection, there may be three, four, five, or more prongs.

indivual,6indivual,7indivual,8indivual,9indivual,10or100forks, or any integer increment therebetween.

[0074] FIG. 1D is a flowchart showing exemplary process steps for monitoring both the motion of a person and the electrical signals generated by the heart of the person according to some embodiments of the present invention. A person is a patient or any other organism under observation monitored by the present system. Referring to FIG. 1A and FIG. 1D, in step 152, an individual, a doctor, or any other care provider serving a person obtains a monitoring device, such as device 110, which is configured to receive data indicating electrical signals and data indicating the motion of the person. The monitoring device 110 includes two or more ports 120 for connecting an ECG lead (e.g., lead 108) that does not include a motion detector and a lead 102 that includes a motion detector in their respective sockets. Each of the two or more ports 120 of the device 110 is structurally equivalent and is configured to receive connectors of the same shape. In step 154, a first ECG lead (e.g., lead 108) is connected to the first port. In an embodiment, lead 108 does not include a motion detector. The first port can be any one of the two or more ports 120 on the device 110. The first end of the lead 108 includes a connector configured to connect to a terminal of the device 110. The second end of the lead 108 includes a socket configured to attach to a person. (receptacle). The socket includes electrodes and does not include a motion detector. In step156In, firstECGThe electrodes of the leads are attached to the person at appropriate locations on the body.158Middle, secondECGLeads, such as leads102,Connect to device110 Two or more ports on 120The second end of .ECGThe lead has a first end configured to be connected to the device110The corresponding end of the connector, such as a plug104.lead102The second end of the socket has a socket, such as a socket106, which includes electrodes and a motion detector, configured to be attached to a person. The motion detector is configured to obtain the position and motion information of the person, and when it is activated, through a secondECGLead wire (lead wire102) transmits position and motion information to the monitoring device110Once the device110is activated, leads102Power is directed to the motion detector and data is transmitted to and from the motion detector.160In a similar way to any otherECGLeads (such as leads108) will be the secondECGThe electrodes of the leads are attached to the person. In some embodiments, the thirdECGLeads at two or more ports 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 indicating electrical signals and data indicating the movement of the person.

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

Fig. 2 shows an orthogonal view of the socket 200 shown in Fig. 1 according to some embodiments of the present invention. The socket 200 includes a housing 206 that surrounds the components of the integrated motion sensor system 204. A wire connector 208 is located at the distal end of the connecting wire 202 in a portion of the housing 206, which docks with an electrode connector, similar to an ECG electrode connector, for attaching the socket 200 to the body of the object. The motion sensor system 204 may include multiple components placed on a printed circuit board (PCB), and includes elements for detecting and processing position and motion-related data. Therefore, 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 second portion 300a of a PCB according to some embodiments of the present invention.

The second part 300b, which is located on the side opposite to the side of the first part 300a, is configured to carry the components of the motion sensor system 204 shown in Figure 2. With reference to Figures 3A and 3B simultaneously, the PCB (300a, 300b) is configured to be accommodated in the housing of the socket of the lead connection wire, which connects the motion sensor system to the monitoring device, which stores and processes the motion sensor data alone or in combination with other physiological monitoring data. In an embodiment, the size of the PCB (300a, 300b) is designed to be assembled in the housing of the socket. In one embodiment, the PCB (300a, 300b) is 0.5 inches long and 0.3 inches wide, with electrical components and electronic components on both sides. In some embodiments, the pad 302 on the PCB (300a, 300b) is configured to solder the ground and power/communication wires to the PCB (300a, 300b).

[0078] The connecting wire can 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. The power from the power supply can be transmitted through the connecting wire 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 the power fluctuation caused by signaling, thereby powering 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. The motion sensor 308 detects position and motion related data and provides the data to the processor 306. In some embodiments, the motion sensor 308 is a multi-axis accelerometer. In one embodiment, the motion sensor 308 is a three-axis accelerometer. In various embodiments, the 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). The sensor is used to provide position and orientation information on 3 axes, which can be used to determine the orientation of the patient, for example to determine if the patient is facing down a hallway rather than across it. Assuming that the accelerometer will indicate The accelerometer can be used to determine the patient's tilt, with a value of 1G straight down (due to gravity). Rapid changes in acceleration indicated by the accelerometer can show the subject's motion, while slow changes in acceleration can indicate changes in tilt (e.g., sitting upright or rolling over). The motion sensor 308 is configured to detect at least one or more of the subject's position, tilt, and motion.

[0079] The present embodiments can be configured to interface with different types of physiological monitoring devices, such as respiratory monitoring devices, BP monitoring devices, and devices that monitor multiple physiological parameters, but in each case, these devices are preferably positioned within the housing of a traditional physiological sensor located on the patient's body.

[0080] Embodiments of the present invention are used to monitor the exercise data of an object. The activity level can be quantified to provide helpful instructions about the exercise performed by the object. For example, the number of steps can be monitored. Embodiments of the present invention can also be used to indicate the type and duration of one or more activities performed by the object. For example, physiological data is combined with posture information to determine whether the object is sitting, standing, awake or asleep within a healthy duration. Similarly, these embodiments can be used to determine the level of inactivity. For example, a bedridden object is monitored for the duration of inactivity, and an alarm is generated to remind the object that it needs to move to avoid bedsores, or whether the object has died. These embodiments can also be used to detect the fall of the object. These embodiments can also be used to detect the movement of the object, which may be unwarranted, unexpected or unhealthy. For example, when the object should not leave alone, the movement of the object leaving the bed can be detected. These embodiments can also be used to detect rapid movements, such as but not limited to seizures, tremors, epileptic seizures, tremors, rapid breathing due to discomfort, coughing, vomiting and rolling in bed.

[0081] Embodiments of the present invention may combine breathing detection data with motion sensor data to monitor chest movement and detect apnea. Additionally, measurement of breathing characteristics may be suppressed during a healthy exercise regimen. Similarly, when combining BP measurement data, if a subject is identified as being overactive, the monitoring attempt may be canceled, delayed, or retried at a later time.

[0082] Embodiments of the present invention help minimize false ECG ST segment alarms that might otherwise occur due to position changes. Additionally, false ECG rhythm alarms due to position changes or due to motion are minimized, such as v-tach (ventricular

If the subject has a critical condition, for example, if the heart rate is low and the pulse amplitude is reduced, the combination of ECG data, respiration data, BP data and motion sensor data according to embodiments of the present invention can detect and issue an appropriate alarm.

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

[0084] In one embodiment, during normal operation, the first transistor 410 in the first device 406 is non-conductive, thereby allowing power from the power supply to pass through the power module 412, through the second transistor 416, and through the first resistor 414 to the wire 402, thereby reaching any connected device, such as the device 408. The first device 406 and the second device 408 each have a non-conductive transistor 416 and 418, respectively. The transistor 418 in the second device 408 is usually non-conductive. Therefore, the power provided by the device 406 to the device 408 through the wire 402 flows to the power module 422 through the diode 420 located between the transistor 418 and the power module 422 in the device 408. The comparator 424 is configured to receive the power sent through the wire 402 in the device 408. The comparator 424 compares the input power rail with the reference voltage and outputs a "low" to the receiving pin on the processor 426 of the device 408.

In one embodiment, in order to transmit a bit from the first device/main device 406 to the second device/slave device 408, the first transistor 410 moves to a conductive state, which switches the transistor 416 to a non-conductive state. The side of the first resistor 414 connected to the wire 402 is pulled to "low" by the conductive transistor 410. On the other side of the wire 402, in the second device 408, the comparator 424 senses that the input power supply becomes "low", and switches the receiving pin on the processor 426 to high. In some embodiments, "low" and "high" represent voltage levels, which can be interpreted as binary data by a digital circuit. In some embodiments, "high" and "low" states can be opposite, that is, "low" can be "high" and "high" can be "low" in the present invention. In some embodiments, the transition from "low" to "high" on the receiving pin represents a binary "1". The diode 420 prevents the voltage of the power module 422 entering the second device 408 from dropping rapidly. When the power supplied to device 408 through its power module 422 begins to draw current from this 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 a sufficient amount of time is given for the second device 408 to cause the input from the wire 402 to fall to "low", the first device 406 turns the first transistor 410 back to the non-conductive state, which turns the transistor 416 to the conductive state, thereby allowing a normal amount of current to flow through the wire 402. If the first transistor 410 is turned on to the conductive state and then returns to the non-conductive state relatively quickly, the second device 408 records this change as data, but the power supplied to the second device 408 remains constant. The amount of time that the transistor 410 changes its state from on to off can be determined based on the amount of current consumed by the device 408, the current leakage back through the diode 420, and the size of the capacitor 428.

[0087] In order for the second device 408 to transmit a data bit to the first device 406, the transistor 416 and therefore the transistor 418 are turned on to a conductive state by the processor 426. The input from the wire 402 through the resistor 430 located between the output of the wire 402 and the transistor 418 of the second device 408 is momentarily pulled to "low". The comparator 432 on the first device 406 senses that the power output through the resistor 414 has dropped to "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 the conduction through the transistor 418,

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

[0088] In an embodiment, the resistor 414 on the first device 406 keeps the regulator of the first device 406 (power source) from overcurrent during intermittent short circuit events seen on the power line during transmissions of the second device 408. During these transmissions, the transistors 416 and 410 are in a conductive state, so any momentary short circuit event of the wire 402 is detected by the power module 412, which causes the system 400 to enter an overcurrent state.

[0089] Communication via wire 402 is asynchronous, meaning that a device (either first device 406 or second device 408) may 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 conflicts. When both devices 406 and 408 send data at the same time, data conflicts may occur. When a device wishes to transmit data, it enters a transmit state. In this state, it should only detect a receive pin change 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) determines that it has sensed a conflict and signals such an event to the upper layer protocols of the processors 434 and 426 of the system 400. Any corrective action (usually compensating for some random amount of time, followed by a retry) will be initiated by the upper layer protocol.

FIG. 5 shows an exemplary circuit 500 in which a system according to some embodiments of the present invention is simulated. In one embodiment, the left side of the circuit 500 is about a device 506 corresponding to the first device 406, as described with reference to FIG. 4. Similarly, the right side of the circuit 500 is about a device 508 corresponding to the second device 408 of FIG. 4. Wire 502 (402) connects devices 506 (406) and 508 (408). The components of FIG. 5 correspond to various components of FIG. 4 and are similarly numbered. For example, transistors 510 and 516 correspond to transistors 410 and 416 of the first device 406/506. In an alternative embodiment, there may be multiple devices similar to device 508, which can be connected to device 506 via wire 502. In an embodiment, the number of devices similar to device 508 that can be connected to device 506 via wire 502 is limited by the power supplied by device 506 and the power consumed by multiple 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 the device 506.

[0091] Referring again to FIG. 4, connected to V_gateThe voltage supply simulation "HostProc" simulates the interaction with the processor 434. The rest of the processor 434 is not simulated. Similarly, the voltage supply simulation "DevProc" simulates the interaction with the processor 426, and the rest of the processor is not simulated. Referring to Figure 5, the resistor "WIreR_1" 540 and the capacitor "WireC_1" 542 are used to simulate the parasitic resistance and capacitance of the wire 502. Finally, the component U5 and the associated components C9 to C13 in the power supply 512 of the first device 506 are optional. In some embodiments, the voltage divider and the operational amplifier constitute the comparator portions 524 and 532 within the devices 508 and 506 of the circuit 500, respectively. However, there is no limitation on this portion of the circuit - other circuits such as those with internal references can also be used.

[0092] FIG. 6A shows the data transmission from the first device 406/506 to the second device 408/508 shown in FIG. 4 and FIG. 5 according to some embodiments of the present invention. Reference is made to the components of FIG. 4 and FIG. 5 simultaneously to enhance the description of the graph. The figure shows the transmission of the value of 0xFFFF (2 groups of 8-bit 1s). The following graph 602 shows the input provided to the transmitting transistor (the transmitting pin of the transistor 410 of FIG. 4). The middle graph 604 shows the comparator 424/524 operational amplifier input on the second device 408/508, wherein 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 the comparator 42/524, which is the same as the transmitted input for all practical purposes. In an exemplary embodiment, these transmissions are simulated at a rate of 100KHz.

FIG. 6B illustrates data transmission from the second device 408/508 to the first device 406/506 in response to the data transmission of FIG. 6A according to some embodiments of the present invention. In the first graph 632, the top trace 634 shows the data transmission from the second device 408/508 to the first device 406/506.

The input power rail of the regulator 422 of the device 408/508. A certain amount of expected drop is seen in trace 632, which occurs as a result of the intermittent drop in power input. However, the output of the power supply remains constant at 3.3V (as shown in the lower trace 636 of the graph 632) because the input is above the drop limit of the regulator. In some embodiments, a regulator with a low drop value is selected to prevent the slave device (e.g., the second device 408/508) from pulling power down to the drop 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 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 straight line 626 is the reference input voltage. Graph 618 shows the output 620 of the comparator 424. Trace 614 in graph 616 shows the signal and reference inputs to the comparator 424, respectively. Trace 610 in the lower graph 612 is the input to the transistor 418 of the second device 408/508.

[0094] In addition, attention should be paid to minimizing the pulse width of the transmitted bit and allowing sufficient recovery time between transmissions. Therefore, the pulse width of each bit is controlled. The bandwidth (baud rate) of the driving transmission can be a factor that controls the pulse width of each bit. Regardless of the baud rate, if the actual data transmission rate is low, the delay of 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. It is easy to adjust equal high-width and low-width pulses between 1kHz and 100kHz without the need to use larger or more expensive components.

[0095] Figures 7A, 7B, and 7c show images of a first end 700 of a wire connecting a first master device 406 (Figure 4) and a second slave device 408 (Figure 4) according to some embodiments of the present invention. The first end 700 is a plug portion of the wire that is connected to a physiological monitoring system such as the device 110 shown in Figure 1. Figure 7A shows a photograph of the plug portion 700 according to 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 the dimensions of its components. Referring to Figures 7A, 7B, and 7C simultaneously, the plug portion includes a pin 702 that is configured to be placed in a corresponding recess of the physiological monitoring device to provide an electrical connection between the wire and the physiological monitoring device. The tip of pin 702 emerges from an approximately 0.8 mm band that connects the tip of pin 702 to an opposite end of pin 702, which extends a length of approximately 3.9 millimeters (mm) and is approximately 2.35 mm in diameter, and the opposite end extends a length of approximately 6.7 mm and is approximately 2.46 mm in diameter. At the opposite end, pin 702 is connected to a protective housing 704. Housing 704 contains a switch of electrical components having wires that provide communication of power and data from and to the physiological monitoring device when the pin is inserted into the physiological monitoring device. The total length of plug portion 700 extends approximately 25.9mmIn an embodiment, the pin portion700Inserts into special pins on physiological monitoring devices or built into the yoke (yoke)middle.

8A-8D show different views of a wire 800 having a plug portion 802 at one end and a socket portion 804 at the other end according to some embodiments of the present invention. FIG8A shows a top view of the socket portion 804 of the wire 800. FIG8B shows a side view of the socket portion 804 of the wire 800. FIG8C shows a cross-sectional side view of the socket portion 804 of the wire 800.

Fig. 8D shows the bottom view of the socket portion 804 of the lead 800. In some embodiments, the lead 800 includes a coaxial cable to avoid crosstalk. In different embodiments, the length of the lead 800 is different to suit various applications. For ECG applications, the length of the lead 800 is similar to that of the ECG lead. Similarly, for ECG applications, the lead 800 has a bending radius similar to that of the ECG lead. In an embodiment, the lead 800 is inserted and removed using similar forces and techniques as used to insert and remove the ECG lead.

2, and the plug portion 802 thereof is used to apply and remove the wire 800. The socket portion 804 corresponds to the socket 200 of Fig. 2, and includes a housing 806 that surrounds the components of the integrated motion sensor system. A lead connector is located at one end of the connecting wire 800 in a portion of the housing 806, and the housing is docked with an electrode connector, similar to an ECG electrode connector, for attaching the socket portion 804 to the patient's body. As described above, the motion sensor system may include multiple components placed on a printed circuit board (PCB), and include elements for detecting and processing position and motion-related data. In an embodiment, the housing 806 is waterproof. The socket portion 804 may be configured to any known and used connector to be positioned on an object.

[0098] The above examples are merely illustrations of many applications of the system of the present invention. Although only a few embodiments of the present invention are described herein, it should be understood that the present invention may be implemented in many other specific forms without departing from the spirit or scope of the present invention. Therefore, the present examples and embodiments should be considered illustrative rather than restrictive, and the present invention may be modified within the scope of the appended claims.

CN 114040710 Β