Patent Description:
Patient monitoring devices are essential medical devices that provide vital physiological data to clinicians and caregivers for the care of patients. However, patient monitoring can present challenges both inside and outside hospital environments. For example, patients that are admitted to a healthcare facility may require continuous physiological monitoring, and this continual physiological monitoring can be a data intensive task. These challenges can be accentuated when the patients being monitored are ambulatory (i.e., moveable) because the devices used for monitoring patient parameters are also required to be ambulatory (i.e., moveable) so that patients are not confined to a particular bed or to a particular care unit.

Healthcare facilities have been outfitted with a network of wireless access points that enable wireless communication between a central monitoring station and patient monitoring devices. With the implementation of wireless data communications, the ability to remotely monitor patients has expanded the use of ambulatory patient monitoring devices used for monitoring physiological data. However, even with ambulatory patient monitoring devices, there are still challenges regarding device performance, patient compliance, and quality of life for patients when these devices are used over long periods of time.

Additionally, with hospital enterprises now expanding to alternate lower acuity care settings such as rehabilitation centers, the requirements for continuous physiological data monitoring has become more focused on quality of life when considering patients are more mobile (ambulatory) and the physiological monitors are operating <NUM> hours a day.

Thus, it would be advantageous and an improvement over conventional patient monitoring systems to provide a patient worn physiological monitoring device or system for ambulatory patients that improve device performance, patient compliance, quality of life for patients, and overall patient outcomes during ambulatory activity associated with recuperation and rehabilitation.

<CIT> appears to disclose an ECG monitoring system for ambulatory patients includes a reusable battery-powered ECG monitor with an electrode attached to a patient for receiving ECG signals. A processor analyzes the received ECG signals for predefined arrhythmia. If an arrhythmia is detected, a wireless transceiver in the ECG monitor transmits the event information and an ECG strip to a cellphone handset. The cellphone handset automatically relays the event information and ECG strip to a monitoring center for further diagnosis and necessary intervention. The ECG monitor sends notifications to the cellphone handset whenever the status of the monitor changes. The cellphone handset forwards status notifications to which a patient response has not been received to the monitoring center, as well as status notifications generated by the cellphone handset.

<CIT> appears to disclose a wearable wireless <NUM>-channel electrocardiogram system which includes: a wearable integrated electrocardiogram measurement device including a single electrode sheet having <NUM> electrodes and capable of being attached to a chest, and a micro-electrocardiogram measurement module detachably attached to and integrated with the electrode sheet, and configured to receive electrical signals from the <NUM> electrodes, to process the received signals and to transmit the processed signals to the outside; and a radio device including a controller configured to analyze and process electrocardiogram measurement information received from the wearable integrated electrocardiogram measurement device into <NUM> channels and to transmit the analyzed and processed electrocardiogram measurement information to an external server.

<CIT> appears to disclose providing physiological monitoring through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline (or immediately to either side of the sternum) benefits extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. The wearable monitor can interoperate wirelessly with other physiology and activity sensors and mobile communications devices, to download monitoring data either in real-time or in batches. The monitor recorder can provide data or other information to, or receive data or information from, an interfacing physiology or activity sensor, or mobile communications devices for relay to a further device, such as a server, analysis, or other purpose.

The scope of the present invention is defined by the appended independent claim <NUM>. In an embodiment described in the present disclosure, a physiological monitoring system for providing monitoring of a patient includes an electrocardiogram (ECG) module having an ECG microcontroller and a first plurality of electrodes worn on the patient; and a main module detachably worn by the patient and connected to the ECG module by a first communication connection. The ECG microcontroller is coupled to the first plurality of electrodes for receiving first physiological data gathered by the first plurality of electrodes, and the main module is configured to receive the first physiological data from the ECG module using the first communication connection.

The ECG microcontroller is further configured to analyze the first physiological data gathered by the first plurality of electrodes, identify one or more abnormal conditions of the patient, and transmit in real-time results of the analysis of the first physiological data and the identified abnormal conditions to the main module using the first communication connection. The first communication connection is a wireless communication connection.

In an embodiment described in the present disclosure, the physiological monitoring system further comprising a detachable precordial electrode array including a second plurality of electrodes worn in a precordial location of the patient proximate to the ECG module. The second plurality of electrodes are configured to gather second physiological data, and the ECG module is connected to the detachable precordial electrode array by a second communication connection.

The ECG microcontroller is further configured to analyze the second physiological data gathered by the second plurality of electrodes, identify one or more abnormal conditions of the patient, and transmit in real-time results of the analysis of the second physiological data and the identified abnormal conditions to the main module using the first communication connection. The first communication connection is a wireless communication connection, and the second communication is a wired communication connection.

In an embodiment described in the present disclosure, the main controller is further configured to transmit in real-time results of the analysis of the first physiological data or the second physiological data and the identified abnormal conditions using a first wireless protocol of the communication interface, or store the first physiological data or the second physiological data and the identified abnormal conditions in the on-board memory when the main module is unable to transmit the in real-time using the first wireless protocol of the communication interface.

The main controller is further configured transmit in real-time results of the analysis of the first physiological data or the second physiological data and the identified abnormal conditions using a second wireless protocol of the communication interface if a significant physiological event is identified from the analysis of the first physiological data or the second physiological data. The first wireless protocol is in accordance with WIFI or Bluetooth, whereas the second wireless protocol is in accordance with a cellular network.

In an embodiment described in the present disclosure, the detachable precordial electrode array is connected to the main module by a third communication connection for transmitting the second physiological data gathered by the second plurality of electrodes to the main module. The main controller is configured to receive the second physiological data from the ECG module using the third communication connection, wherein the third connection is a wired connection.

In an embodiment described in the present disclosure, the detachable precordial electrode array includes a plurality of electrodes worn in a precordial location of the patient, and a communication connection for transmitting the physiological data gathered by the plurality of electrodes. The plurality of electrodes are formed in a flexible material integrated as a patch and having a bottom surface that is attachable to the patient for gathering the physiological data.

In an embodiment described in the present disclosure, a patch with the first plurality of electrodes is detachable from the data acquisition module and disposable, and the data acquisition module is re-useable.

In an embodiment described in the present disclosure, the data acquisition module and the patch with the first plurality of electrodes are integrated, and both the patch and the data acquisition module are disposable.

In an embodiment described in the present disclosure, the ECG module further comprises adjustment slots and a location of each of the first plurality of electrodes is adjustable within the adjustment slots.

In an embodiment described in the present disclosure, the detachable precordial array further comprises adjustment slots and a location of each of the second plurality of electrodes is adjustable within the adjustment slots.

<FIG> is a block diagram of a main module for physiological monitoring according to an embodiment of the present disclosure.

As shown in <FIG>, the main module <NUM> is attached to several different types of electrodes and sensors known in the art for gathering physiological data related to a patient (e.g., as shown on the left side of <FIG>). The electrodes and sensors are attached to the main module by, for example, a wired connection. However, the main module <NUM> can also be connected to wireless sensors using communication interface circuity for receiving data from and sending data to one or more devices using, for example, a Bluetooth connection <NUM>. The data signals from the electrodes and sensors received by the main module <NUM> include data related to an electrocardiogram (ECG), non-invasive peripheral oxygen saturation (SpO2), non-invasive blood pressure (NIBP), temperature, and/or tidal carbon dioxide (eTCO2). For example, the data signals related to ECG and SpO2 are received respectively from the precordial ECG electrodes <NUM> and the SpO2 sensor <NUM>. The data signals received from the precordial ECG electrodes <NUM> and the SpO2 sensor <NUM> are, for example, analog signals. The data signals from the precordial ECG electrodes <NUM> are input to the ECG data acquisition circuit <NUM> and the SpO2 data signal from the SpO2 sensor <NUM> is input to the SpO2 data acquisition circuit <NUM>. Both the ECG data acquisition circuit <NUM> and the SpO2 data acquisition circuit <NUM> include amplifying and filtering circuity as well as analog-to-digital (A/D) circuity that convert the analog signal to a digital signal using amplification, filtering, and A/D conversion methods known in the art.

The data signals related to NIBP, temperature, and eTCO2 are received from a detachable physiological sensors <NUM> connected to the main module <NUM> through an external physiological parameter interface <NUM>. The external physiological parameter interface <NUM> includes, for example, serial interface circuitry for receiving and processing the data signals related to NIBP, temperature, and eTCO2. The processing performed by the ECG data acquisition circuit <NUM>, the SpO2 data acquisition circuit <NUM>, and external physiological parameter interface <NUM> produces digital data waveforms, which are passed to a dedicated microcontroller <NUM> by electrical connection therebetween. The digital data waveforms are analyzed by the microcontroller <NUM> to identify any abnormal conditions of the patient. The microcontroller <NUM> analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient using methods known in the art.

The microcontroller <NUM> is, for example, a processor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a digital signal processor (DSP), or similar processing device. The microcontroller <NUM> also includes a memory. The memory is, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), a read only memory (ROM), a flash memory, or a hard disk.

The memory stores software or algorithms with executable instructions and the microcontroller <NUM> can execute a set of instructions of the software or algorithms in association with executing an operation of analyzing the digital data waveforms related to the data signals of the electrodes and sensors <NUM>, <NUM>, and <NUM> to identify abnormal conditions of the patient.

The results of the analysis by the microcontroller <NUM> are passed to the microcontroller <NUM> by an electrical connection between the microcontrollers <NUM>, <NUM>. The microcontroller <NUM> is, for example, a processor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a digital signal processor (DSP), or similar processing device. The microcontroller <NUM> also includes a memory. The memory is, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), a read only memory (ROM), a flash memory, or a hard disk.

Additionally, the microcontroller <NUM> includes communication interface circuitry for establishing communication connections with various devices and networks using both wired and wireless connections for transmitting physiological data, results of the analysis by the microcontroller <NUM>, and alerts and/or alarms to the patient, clinicians and caregivers regarding any abnormal conditions detected. Additionally, the memory in the microcontroller <NUM> stores software or algorithms with executable instructions and the microcontroller <NUM> can execute a set of instructions of the software or algorithms in association with establishing communication connections with various devices and networks using both wired and wireless connections.

As shown in <FIG>, wireless communication connections established by the communication interface circuity of microcontroller <NUM> include a Bluetooth connection <NUM>, a cellular network connection <NUM>, and a WiFi connection <NUM>. The wireless communication connections allow for alerts and physiological data to be transmitted in real-time within a hospital wireless communications network (e.g., WiFi) as well as allow for alerts and physiological data to be transmitted in real-time to other devices (e.g., Bluetooth and cellular networks). For example, if the patient monitor (i.e., main module <NUM>) detects a physiological event, an alert or alarm along with pertinent data can transmitted through the cellular network <NUM> to the clinician and/or health care facility. As another example, if the Bluetooth connection <NUM> or WIFI connection <NUM> are not available (e.g., out of transmission range or not operable), and a significant physiological event is detected, the microcontroller <NUM> can transmit the physiological event, and an alert along with pertinent data using the cellular network connection <NUM>.

It is also contemplated by the disclosure of the present application that the communication connections established by the microcontroller <NUM> enable communications over other types of wireless networks using alternate hospital wireless communications such as wireless medical telemetry service (WMTS), which can operate at specified frequencies (e.g., <NUM>). Other wireless communication connections can include wireless connections that operate in accordance with, but are not limited to, IEEE802. <NUM> protocol, a Radio Frequency For Consumer Electronics (RF4CE) protocol, ZigBee protocol, and/or IEEE802. <NUM> protocol.

The Bluetooth connection <NUM> can be used to provide the transfer of data to a nearby device (e.g. tablet) for review of data and/or changing of operational settings of the main module <NUM>. The Bluetooth connection <NUM> also provides wireless communications between the main module <NUM> and wireless physiological sensors (e.g., ECG, SpO2). Wireless physiological sensors have the advantage of eliminating wires, which get tangled, disconnected, or fail. The microcontroller <NUM> of the main module <NUM> provides communication connection by direct wired (e.g., hard-wired) connections as well for transferring data using, for example, a USB connection <NUM> to a tablet, PC, or similar electronic device; or using, for example, a USB connection <NUM> to an external storage device or memory.

Additionally, the microcontroller <NUM> includes a connection to a graphical user interface (GUI) <NUM> for displaying information, physiological data, measured data, and/or alerts/alarms to the patient, or to clinicians and caregivers proximate to the main module <NUM>. Although the main module <NUM> is described in <FIG> as having two microcontrollers <NUM>, <NUM>, it is contemplated by the disclosure of the present application that one microcontroller could be implemented to perform the functions of the two microcontrollers <NUM>, <NUM>.

The GUI <NUM> is, for example, a liquid crystal display (LCD), cathode ray tube (CRT), thin film transistor (TFT), light-emitting diode (LED), high definition (HD) or other similar display device with touch screen capabilities. The GUI is provided with means for inputting instructions or information directly to the main module <NUM>.

As shown in <FIG>, the main module <NUM> also includes a GPS <NUM> that can transmit to the clinician or caregiver the location of the patient. If it is determined by the microcontroller <NUM> that the patient is not within the vicinity of the hospital wireless communications system (e.g., based on input from the GPS <NUM>), the pertinent physiological data (e.g., full disclosure and physiological signal measurements) can be recorded and stored in an on-board memory <NUM>. Additionally, if the Bluetooth connection <NUM> or WIFI connection <NUM> are not available (e.g., out of transmission range or not operable), and a physiological event detected is not significant, then the microcontroller can stored the physiological data (e.g., full disclosure and physiological signal measurements) in the on-board memory <NUM> for later transmission when the Bluetooth connection or WIFI connection become available.

The on-board memory <NUM> is, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), a read only memory (ROM), a flash memory, or a hard disk.

Power can be supplied to the main module <NUM> using a rechargeable battery <NUM> that can be detached allowing for replacement. The rechargeable battery <NUM> is, for example, a rechargeable lithium-ion battery. Additionally, a small built-in back-up battery <NUM> (or super capacitor) is provided for continuous power to main module <NUM> during battery replacement. A power supply regulation circuit <NUM> is provided between the rechargeable battery <NUM> and small back-up battery <NUM> to control which of batteries <NUM>, <NUM> provide power to the main module <NUM>. The main module <NUM> also includes a patient ground connection <NUM> for providing as a reference when acquiring the ECG signals. The patient ground connection <NUM> can be used as a ground for single ended unipolar input amplifiers (e.g., precordial leads), or as a ground for bipolar input amplifiers (e.g., limb leads).

<FIG> is an exemplary algorithm executed by the microcontrollers of the main module according to an embodiment of the present disclosure.

In step S1, the microcontroller <NUM> of the main module <NUM> receives the digital data waveforms from the ECG data acquisition circuit <NUM>, the SpO2 data acquisition circuit <NUM>, and external physiological parameter interface <NUM>. The memory of the microcontroller <NUM> has stored in advance digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. In step S2, the microcontroller <NUM> analyzes the received digital data waveforms using the stored digital waveform characteristics and threshold levels, and identifies any abnormal conditions by comparing the stored digital waveform characteristics and threshold levels with the received digital data waveforms. In step S3, if it is determined that no abnormal condition exist, the microcontroller <NUM> continues to analyze the received digital data waveforms that are received, as in step S2. However, in step S3, if it is determined that any abnormal condition exist, then the microcontroller <NUM> transmits the results of the analysis to the microcontroller <NUM> of the main module <NUM> by an electrical connection between the microcontrollers <NUM>, <NUM>.

In step <NUM>, the microcontroller <NUM> determines if the WIFI connection <NUM> or the Bluetooth connection <NUM> is available for transmissions. For example, the microcontroller <NUM> may determine that the main module <NUM> is not within transmission range for using the WIFI connection <NUM> or the Bluetooth connection <NUM>, or determine that the WIFI connection <NUM> or the Bluetooth connection <NUM> is not operable. If it is determined by the microcontroller <NUM> that the WIFI connection <NUM> or the Bluetooth connection <NUM> is available, then in step S5 the microcontroller <NUM> transmits the physiological data and alerts along with other pertinent data using the WIFI connection <NUM> or the Bluetooth connection <NUM>.

However, in step S4, if it is determined that the WIFI connection <NUM> or the Bluetooth connection <NUM> is not available for transmissions, then in step S6 the microcontroller <NUM> determines if a significant physiological event has been detected (e.g., a significant physiological event requiring immediate attention by a physician or caregiver). If it is determined that a significant physiological event has been detected, then in step S7 the microcontroller <NUM> transmits the physiological data and alerts along with other pertinent data using the cellular connection <NUM>. However, if it is determined that no significant physiological event has been detected, then in step S8 the microcontroller <NUM> stores the physiological data in the on-board memory <NUM> for later transmission when the WIFI connection <NUM> or the Bluetooth connection <NUM> become available, as determined in steps S4-S5.

<FIG> is a block diagram showing a wireless electrocardiogram (ECG) module according to an embodiment of the present disclosure. The wireless ECG module <NUM> can have two configurations for physiological data acquisition. During continuous monitoring, the wireless ECG module <NUM> is connected to a minimal set (e.g., <NUM>) of ECG electrodes <NUM> that provide data signals related to an electrocardiogram (ECG), similar to <NUM> channel limb leads known in the art. In an alternative embodiment, additional ECG electrodes can be added. For example, a fourth ECG electrode (not shown) can be added, which can be provided as a ground reference for the data acquisition circuits <NUM>. Additionally, when an acute recording of a <NUM> lead ECG configuration is required, an additional set of electrodes (e.g., <NUM> or more) can be added and placed in precordial locations. For example, a precordial array of electrodes can be connected to the wireless ECG module <NUM> using electrical connections <NUM> to the data acquisition circuitry <NUM> (e.g., each electrode having a separate connection <NUM> to the data acquisition circuitry <NUM>). From the above example, a <NUM> lead ECG can be derived from the ECG data signals of the <NUM> electrodes.

As shown in <FIG>, the ECG electrodes <NUM> transmit ECG data signals to the data acquisition circuit <NUM> of the wireless ECG module <NUM>. The ECG electrodes are integrated with the wireless ECG module and transmit ECG data signals by an electrical connection therebetween. The data signals from the ECG electrodes <NUM> are, for example, analog signals. The data signals from the ECG electrodes <NUM> are input to an ECG data acquisition circuit <NUM>, which is similar to the data acquisition circuit <NUM> of the main module <NUM>. That is, the ECG data acquisition circuit <NUM> includes amplifying circuitry, filtering circuity, and A/D circuity that convert the analog signals to digital signals using amplification, filtering, and A/D conversion methods known in the art.

The processing of the ECG data signals by the ECG data acquisition circuit <NUM> produces digital data waveforms, which are passed to a microcontroller <NUM> by electrical connection therebetween. The microcontroller <NUM> analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller <NUM> is, for example, a processor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a digital signal processor (DSP), or other similar processing device. The microcontroller <NUM> also includes a memory. The memory is, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), a read only memory (ROM), a flash memory, or a hard disk.

The memory stores software or algorithms with executable instructions and the microcontroller <NUM> can execute a set of instructions of the software or algorithms in association with executing an operation of analyzing the digital data waveforms related to the data signals of the ECG electrodes <NUM> to identify abnormal conditions of the patient. <FIG> is an exemplary algorithm executed by a microcontroller <NUM> of the wireless ECG module <NUM>. In step S9, the microcontroller <NUM> of the wireless ECG module <NUM> receives the digital data waveforms from the ECG data acquisition circuit <NUM>. The memory of the microcontroller <NUM> has stored in advance digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. In step S10, the microcontroller <NUM> analyzes the received digital data waveforms using the stored digital waveform characteristics and threshold levels, and identifies any abnormal conditions. The microcontroller <NUM> can identify any abnormal cardiac conditions (e.g. arrhythmias, or ST segment measurements indicative of ischemia or myocardial infarction).

In step S11, if it is determined that no abnormal condition exist, the microcontroller <NUM> continues to analyze the physiological data waveforms received, as in step S10. However, in step S11, if it is determined that any abnormal condition exist, then in step S12 the microcontroller <NUM> transmits the results to the patient in the way of an alert or alarm, and/or transmits the results to the main module <NUM> via a wireless Bluetooth connection <NUM>.

The memory in the microcontroller <NUM> stores software or algorithms with executable instructions and the microcontroller <NUM> can execute a set of instructions of the software or algorithms in association with establishing communication connections with various devices and networks using the wireless communication interface circuity of the microcontroller <NUM>.

Referring again to <FIG>, wireless communication connections established by the wireless communication interface circuity of microcontroller <NUM> include a Bluetooth connection <NUM> to the main module <NUM>. The Bluetooth connection <NUM> enables the microcontroller to transmit alerts and physiological data to the main module <NUM> in real-time. It is also contemplated by the disclosure of the present application that the communication connections established by the microcontroller <NUM> enable communications over other types of wireless networks such wireless connections that operate in accordance with, but is not limited to, IEEE802. <NUM> protocol, a Radio Frequency For Consumer Electronics (RF4CE) protocol, ZigBee protocol, and/or IEEE802. <NUM> protocol. As a backup to the wireless connection, alerts and physiological data can be transmitted to the main module <NUM> in real-time using a serial connection <NUM>.

The microcontroller <NUM> can also transmit a signal to an internal alarm <NUM> (i.e., if an abnormal condition is detected) using, for example, a vibratory response to the patient's skin to directly alert the patient. Additionally, pertinent physiological data (e.g., full disclosure and physiological signal measurements) can be stored in on-board memory <NUM> electrically connected to the microcontroller <NUM>. The on-board memory <NUM> is, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), a read only memory (ROM), a flash memory, or a hard disk. As shown in <FIG>, power can be supplied to the wireless ECG module <NUM> by a rechargeable battery <NUM> that can be recharged via a power connection <NUM> to the wireless ECG module <NUM>. The rechargeable battery <NUM> is, for example, a rechargeable lithium-ion battery that can be detached allowing for replacement. The wireless ECG module <NUM> also includes a patient ground connection <NUM> for providing as a reference when acquiring the ECG signals. The patient ground connection <NUM> can be used as a ground for single ended unipolar input amplifiers (e.g., precordial leads), or as a ground for bipolar input amplifiers (e.g., limb leads).

<FIG> is a diagram of a physiological monitoring system according to an embodiment of the present disclosure.

As shown in <FIG>, the physiological monitoring system includes the main module <NUM> and the wireless ECG module <NUM> that communicate with each other via a wireless communication link <NUM>. In a preferred embodiment, the wireless communication link <NUM> established between main module <NUM> and the wireless ECG module <NUM> is implemented in accordance with a Bluetooth protocol. The wireless communication link <NUM> enables the wireless ECG module <NUM> to transmit alerts and physiological data to the main module <NUM> in real-time. It is also contemplated by the disclosure of the present application that the wireless communication link <NUM> established by the wireless ECG module <NUM> and the main controller <NUM> is in accordance with other wireless protocols such as, but not limited to, IEEE802. <NUM> protocol, a Radio Frequency For Consumer Electronics (RF4CE) protocol, ZigBee protocol, and/or IEEE802. <NUM> protocol. As a backup to the wireless communication link <NUM>, alerts and physiological data is transmitted to the main module <NUM> in real-time using, for example, a serial connection <NUM> of the wireless ECG module <NUM>.

As shown in <FIG>, the main module <NUM> includes a user interface that provides a means for inputting instructions or information directly to the main module <NUM>. The user interface includes a display screen that is, for example, a liquid crystal display (LCD), cathode ray tube (CRT), thin film transistor (TFT), light-emitting diode (LED), high definition (HD) or other similar display device with touch screen capabilities. The user interface of the main module <NUM> also provides controls to optimize the viewing of data, which include, but are not limited to, keys, buttons, knobs, touch screen or other similar input devices that can be used to input instructions to the main module <NUM>.

As shown in <FIG>, the main module <NUM> is worn by the patient (e.g., on the hip) using a mechanical device or mechanism such as, but not limited to, a clip or strap attached to a surface of the main module <NUM>. However, the main module <NUM> is detachable and can be removed and held by the patient or set down at a location proximate to the patient. For example, the main module <NUM> can be placed in a nearby location when the patient is stationary or sleeping (e.g., on a night table).

The wireless ECG module <NUM> includes a data acquisition module <NUM> composed of a flexible polymer material with embedded circuity and an electrode patch <NUM>. The embedded circuity of the data acquisition module <NUM> includes, for example, the data acquisition circuit <NUM>, microcontroller <NUM>, on-board memory <NUM>, the rechargeable battery <NUM>, and patient alarm <NUM>, as described with reference to <FIG>. The electrode patch <NUM> of the wireless ECG module <NUM> is composed of, for example, a breathable porous material integrated with a minimal set (e.g., <NUM>) of ECG electrodes <NUM>. In an alternative embodiment, additional ECG electrodes can be added. Additionally, the electrode patch <NUM> can also be composed of silicon, polymer, foam, cloth, or similar material.

The electrode patch <NUM> of the wireless ECG module <NUM> is attached to the chest of the patient using, for example, a biocompatible adhesive or an adhesive surface on the bottom surface of the electrode patch <NUM> facing the patient's skin. However, the electrode patch <NUM> can be made from a material that is self-adhesive. As shown in <FIG>, the wireless ECG module <NUM> is located over the heart (e.g., left side of chest) with the electrode patch <NUM> including the ECG electrodes <NUM> (e.g., <NUM>) located in a similar orientation as the typical <NUM> lead (LA, RA, LL) limb lead configuration known in the art. The orientation of the electrodes <NUM> can also be placed in alternative positions on the patient's chest depending on the patient's anatomy or the area of the heart of diagnostic interest. Once attached to the patient, the electrical signals from the electrodes <NUM> are received by the data acquisition module <NUM> using flexible wire interconnections in the wireless ECG module <NUM> that connect the electrodes to the embedded circuitry of the data acquisition module <NUM>.

The ECG data signals from the electrodes <NUM> are received by the data acquisition module <NUM>, and processed by the embedded circuity as described previously with reference to <FIG> and <FIG>. For example, the data signals from the ECG electrodes <NUM> are input to an ECG data acquisition circuit <NUM>, which includes amplifying circuitry, filtering circuity, and A/D circuity that convert the analog signals to digital signals using amplification, filtering, and A/D conversion methods known in the art.

The processing of the ECG data signals by the ECG data acquisition circuit <NUM> produces digital data waveforms that are passed to a microcontroller <NUM>, which analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller <NUM> can identify any abnormal cardiac conditions (e.g. arrhythmias, or ST segment measurements indicative of ischemia or myocardial infarction).

If it is determined that any abnormal condition exist, then the microcontroller <NUM> transmits the results to the patient in the way of an alert or alarm, and/or transmits the results to the main module <NUM> via the wireless communication link <NUM>. When transmitting an alert or alarm to the patient, the microcontroller <NUM> transmits a signal to the internal alarm <NUM> using, for example, a vibratory response directly to the patient's skin. When the results are transmitted to the main module <NUM> via the wireless communication link <NUM>, the microcontroller <NUM> of the main module <NUM> can establish communication connections using both wired and wireless connections for transmitting physiological data, results, and alerts and/or alarms to the patient, clinicians, and caregivers regarding any abnormal conditions detected as well as store the physiological data in the on-board memory <NUM>, as described previously with reference to <FIG> and <FIG>.

<FIG> is a diagram of a physiological monitoring system including a precordial electrode array connected to the wireless ECG module according to an embodiment of the present disclosure.

The physiological monitoring system of <FIG> differs from <FIG> in that in the physiological monitoring system of <FIG> includes a precordial electrode array (or set) <NUM>. The precordial electrode array <NUM> can be placed over the precordial locations of the right and left chest proximate to the ECG wireless module <NUM>. It is known in the art that the precordial locations are the best locations to detect the heart's electrical activity associated with the septal surface, the anterior wall of the right and left ventricles, and lateral wall of the left ventricle. The precordial electrode array <NUM> is composed of a breathable porous material integrated with the electrodes <NUM> (e.g., <NUM> or more electrodes). However, the precordial electrode array <NUM> can also be composed of silicon, polymer, foam, cloth, or similar material. The precordial electrode array <NUM> is attached to the patient using, for example, a biocompatible adhesive or an adhesive surface on the bottom surface of the precordial electrode array <NUM> facing the patient's skin. However, the precordial electrode array <NUM> can be made from a material that is self-adhesive.

As shown in <FIG>, the precordial electrode array <NUM> is connected to the wireless ECG module <NUM> through, for example, an external connection port (e.g., ECG cable port) in the data acquisition module <NUM>. The precordial electrode set <NUM> includes a cable <NUM> that terminates with an in-line connector <NUM>. The in-line connector <NUM> is received in the external connection port (e.g., ECG cable port) of the data acquisition module <NUM>, which establishes an electrical connection with the embedded circuity (e.g., connections <NUM> to the data acquisition circuit <NUM>), thereby also establishing a connection between the precordial electrode array <NUM> and the wireless ECG module <NUM>. This configuration provides the capability of obtaining additional ECG data for a diagnostic data similar to the <NUM> lead recording without having to remove the primary electrodes (e.g., <NUM>) of the wireless ECG module <NUM>. A ground reference for the precordial electrode array <NUM> can be a remote electrode located remote from the precordial set (not shown). Alternatively, the ground reference can be derived from the <NUM> lead set received through the wireless communication link <NUM>, and converted back to an analog signal. Once the additional <NUM> lead ECG data is obtained, the precordial electrode array <NUM> can be disconnected after it is determined that the additional diagnostic ECG data is no longer required. Thus, the <NUM> lead set does not have to be moved or removed during extended <NUM> lead ECG recording.

The cable <NUM> between the precordial electrode set <NUM> and the wireless ECG module <NUM> is, for example, an electrical cable or other similar interface cable. Once attached, the electrical signals from the electrodes <NUM> of the precordial electrode array <NUM> are received by the data acquisition module <NUM> of the wireless ECG module <NUM>, and the data signals are processed by the embedded circuity as described previously with reference to <FIG> and <FIG>.

For example, the data signals from the electrodes <NUM> are input to an ECG data acquisition circuit <NUM>, which includes amplifying circuitry, filtering circuity, and A/D circuity that convert the analog signals to digital signals using amplification, filtering, and A/D conversion methods known in the art. The processing of the ECG data signals by the ECG data acquisition circuit <NUM> produces digital data waveforms that are passed to a microcontroller <NUM>, which analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller <NUM> can identify any abnormal cardiac conditions (e.g. arrhythmias, or ST segment measurements indicative of ischemia or myocardial infarction).

<FIG> is a top view of the wireless ECG module and <FIG> is a side view of the wireless ECG module according to an embodiment of the present disclosure.

As shown in <FIG>, the wireless ECG module <NUM> includes a data acquisition module <NUM> with embedded circuity and an electrode patch <NUM>. The embedded circuity of the data acquisition module <NUM> includes, for example, the data acquisition circuit <NUM>, microcontroller <NUM>, on-board memory <NUM>, the rechargeable battery <NUM>, and patient alarm <NUM>, as described with reference to <FIG>. The data acquisition module <NUM> data acquisition module <NUM> is composed of, for example, a flexible polymer or other similar material.

The electrode patch <NUM> of the wireless ECG module <NUM> is composed of, a breathable porous material integrated with a minimal set (e.g., <NUM>) of ECG electrodes <NUM>, similar to <NUM> channel limb leads known in the art. However, the electrode patch can also be composed of silicon, polymer, foam, cloth, or similar material.

In this embodiment, the ECG data acquisition module <NUM> can be a reusable device and detachably connected to the electrode patch <NUM>, whereas the electrode patch <NUM> (including the electrodes) is disposable. The ECG electrode patch <NUM> is composed of a material that is a flexible porous structure to allow the patient's skin to "breathe. " The ECG data acquisition module <NUM> is composed of a flexible material such as a polymer that is resistant to water ingress, which allows the patient to take a shower or bath while wearing the wireless ECG module <NUM>. The polymer can also be flexible to allow the wireless ECG module <NUM> to conform to the patient's body. Once the ECG data acquisition module <NUM> attached to a new electrode patch <NUM>, the three (<NUM>) electrodes are connected underneath the ECG electrode patch by flexible circuity to the data acquisition module <NUM> for detecting the ECG voltage signals.

<FIG> illustrates a side view of the wireless ECG wireless module <NUM> with the ECG data acquisition module <NUM> attached to the ECG electrode patch <NUM>. As shown in <FIG>, the electrodes <NUM> are located on the outer periphery of the electrode patch <NUM> with a bottom surface of the electrodes configured to come into contact with the patient's skin. In this embodiment, the ECG data acquisition module <NUM> is a reusable device and detachably connected to the electrode patch <NUM>, whereas the electrode patch <NUM> (including the electrodes) is disposable and composed of a material that is a flexible porous structure to allow the patient's skin to "breathe. " The ECG data acquisition module <NUM> is composed of a flexible material (e.g., silicone or polymer) that provides protection for the electrical interconnects between the data acquisition module <NUM> and the electrode patch <NUM> against environmental hazards such as moisture.

When the patient is within a higher acuity level of physiological monitoring, there can still be a requirement to obtain a <NUM> lead ECG recording at certain times throughout the course of a day for diagnostic purposes. It is also preferable that the clinicians do not have to remove the electrodes for the <NUM> lead configuration, to attach electrodes for a separate <NUM> lead ECG recorder. Under such conditions, a separate precordial ECG electrode array <NUM> can be attached directly to the patient and the wireless ECG module <NUM> using the cable port <NUM> in the data acquisition module <NUM> for providing additional ECG recordings in precordial locations during the higher acuity monitoring. The precordial electrode set <NUM> includes a cable <NUM> that terminates with an in-line connector <NUM>. The in-line connector <NUM> is received in the ECG cable port <NUM> of the data acquisition module <NUM>, which establishes an electrical connection with the embedded circuity (e.g., connections <NUM> to the data acquisition circuit <NUM>), thereby also establishing a connection between the precordial electrode array <NUM> and the wireless ECG module <NUM>.

The ECG electrode array <NUM> can also be used during cardiac rehabilitation activities to monitor the <NUM> lead ECG signal. Once the requirement for obtaining the precordial ECG waveforms is no longer required, the precordial ECG electrode array <NUM> can be disconnected from the wireless ECG module <NUM> by disconnecting the in-line connector <NUM> of the cable <NUM> from the ECG cable port <NUM> of the wireless ECG module. The precordial electrode array <NUM> can be removed from the patient leaving the primary <NUM> lead ECG patch <NUM> of the wireless ECG module <NUM> attached for additional continuous <NUM> hour (or greater) monitoring.

In another embodiment of the ECG electrode patch <NUM> of the ECG wireless module <NUM>, the ECG electrode patch <NUM> can include additional electrodes (e.g. <NUM> or more) embedded within a flexible polymer insulation for detecting the ECG voltage signal as a precordial ECG electrode array.

<FIG> is side view of the connection between the data acquisition module and the electrode patch of the ECG module according to an embodiment of the present disclosure.

As shown in <FIG>, the connections between the data acquisition module <NUM> and the electrode patch <NUM> includes mechanical connections <NUM>, electrical connections <NUM>, <NUM>, and an O-ring seal <NUM> to protect against water ingress, which allows the patient to shower or take a bath while wearing the wireless ECG module <NUM>. The mechanical connections are, for example, snap plug mechanisms <NUM> that snap into the surface of the electrode patch <NUM>, thereby detachably securing the bottom surface of the data acquisition module <NUM> to the top surface of the electrode patch <NUM>. The electrical connections include, for example, male electrical connectors <NUM> (e.g., <NUM>) that establish an electrical connection with the electrodes <NUM> of the electrode patch <NUM> by coming in contact with the wires or flexible circuit <NUM> embedded in the electrode patch <NUM>. The electrical connections <NUM>, <NUM> allow for ECG signals from the ECG electrodes <NUM> to be transmitted to the ECG data acquisition module <NUM>. Although <FIG> shows the use of male connectors <NUM>, it is also contemplated by the disclosure of the present application that the connectors used for establishing connections between the data acquisition module <NUM> and the electrode patch <NUM> are female connectors or a combination of male and female connectors.

In order to protect against water ingress to the electrical connection between the data acquisition module <NUM> and the electrode patch <NUM>, there is an O-ring seal <NUM> around the electrical connectors <NUM> and positioned between the bottom surface of the data acquisition module <NUM> and the top surface of the ECG electrode patch <NUM>.

<FIG> is a bottom view of the electrode connections of the data acquisition module according to an embodiment of the present disclosure.

As shown in <FIG>, the bottom surface of the data acquisition module <NUM> includes an O-ring seal <NUM> that is concentric and surrounding the electrical connectors <NUM> (e.g., <NUM> connectors) in order to provide a water tight seal, which protects the integrity of the electrical connection between the data acquisition module <NUM> and the electrode patch <NUM>. The water tight seal created by the O-ring seal <NUM> also allows the patient to take a shower or bath while wearing the wireless ECG module <NUM>.

The electrical connectors <NUM> are, for example, male electrical connectors (e.g., <NUM>) that establish an electrical connection with the electrodes <NUM> of the electrode patch <NUM> coming in contact with the wires or flexible circuit <NUM> embedded in the electrode patch <NUM>. It is contemplated by the disclosure of the present application that the connectors used for establishing connections between the data acquisition module <NUM> and the electrode patch <NUM> can be male or female connectors or a combination of male and female connectors.

<FIG> is top view of a precordial electrode array with cable and in-line connector according to an embodiment of the present disclosure.

A separate precordial ECG electrode array <NUM> can be attached directly to the patient and the wireless ECG module <NUM> using the cable port <NUM> in the data acquisition module <NUM> for providing additional ECG recordings in precordial locations during the higher acuity monitoring. The precordial electrode array <NUM> is attached to the chest of the patient using, for example, a biocompatible adhesive or an adhesive surface on the bottom surface of the precordial electrode array <NUM> facing the patient's skin. However, the precordial electrode array <NUM> can be made from a material that is self-adhesive. The precordial electrode array <NUM> is connected to the primary set of electrodes (e.g., <NUM> electrodes) of the wireless ECG module <NUM> through an external connection port (e.g., ECG cable port) in the data acquisition module <NUM>.

The precordial electrode array <NUM> is composed of, a breathable porous material integrated with the electrodes <NUM> (e.g., <NUM> or more electrodes). However, the precordial electrode array <NUM> can also be composed of silicon, polymer, foam, cloth, or similar material. As shown in <FIG>, the precordial electrode array <NUM> includes a cable <NUM> that terminates with an in-line connector <NUM>. The in-line connector <NUM> includes a series of electrical contacts <NUM> that are received in the external connection port (e.g., ECG cable port <NUM>) of the data acquisition module <NUM> and establish an electrical connection with the embedded circuity (e.g., connections <NUM> to the data acquisition circuit <NUM>) and thereby a connection between the precordial electrode array <NUM> and the wireless ECG module <NUM>. This configuration provides the capability of obtaining additional ECG data as diagnostic data similar to the <NUM> lead recording without having to remove the primary electrodes (e.g., <NUM>) of the wireless ECG module <NUM>.

The in-line connector <NUM> also includes a seal <NUM> that is concentric around the ECG cable <NUM> for providing a water tight seal, thereby protecting the integrity of the electrical connection between the data acquisition module <NUM> and the precordial electrode array <NUM> when the in-line connector is received in the external connection port (e.g., ECG cable port <NUM>) of the data acquisition module <NUM>. Having the seal <NUM> integrated within the ECG cable <NUM> rather than having an O-ring within the connector cavity can improve the reliability of the seal by avoiding a multi-use configuration.

The in-line connector <NUM>, once establishing a connection between the data acquisition module <NUM> and the precordial electrode array <NUM>, is held securely in place using a lock mechanism such as a keyed twist lock <NUM>. When the keyed twist lock <NUM> is inserted in the external connection port of the data acquisition module <NUM>, the keyed twist lock <NUM> is twisted (e.g., <NUM>° in the clockwise direction) and aligned within a grooved slot (e.g., in the external connection port). The In-line connector <NUM> is guided into place in the external connection port of the data acquisition module <NUM> by holding the strain relief portion <NUM> of the in-line connector <NUM>, which prevents damage to the precordial electrode array <NUM> and the cable <NUM>. The strain relief portion <NUM> is integrated into the ECG cable <NUM>, which can also provide additional protection from water ingress.

The ECG electrode array <NUM> can be used during cardiac rehabilitation activities to monitor the <NUM> lead ECG signal. Once the requirement for obtaining the precordial ECG waveforms is no longer required, the precordial ECG electrode array <NUM> can be disconnected from the wireless ECG module <NUM> by disconnecting the in-line connector <NUM> of the cable <NUM> from the ECG cable port <NUM> of the wireless ECG module <NUM>. The precordial electrode array <NUM> can be removed from the patient leaving the primary <NUM> lead ECG patch <NUM> of the wireless ECG module <NUM> attached for additional continuous <NUM> hour (or greater) monitoring.

<FIG> is a cross-sectional view of the keyed twist lock of the ECG cable for the precordial electrode array according to an embodiment of the present disclosure.

The in-line connector <NUM>, once in place and establishing a connection between the data acquisition module <NUM> and the precordial electrode array <NUM>, is held securely in place using an integrated keyed twist lock <NUM>.

As shown in <FIG>, the keyed twist lock <NUM> is integrated with the cable <NUM>, similar to the seal <NUM>. The key twist lock <NUM> is inserted into a grooved slot of the external connection port (e.g., ECG cable port <NUM>) of the data acquisition module <NUM> and twisted, for example, <NUM>° in a clockwise direction and aligned within a grooved slot, thereby securing the connection between the in-line connector <NUM> and the data acquisition module <NUM>. Once the requirement for obtaining the precordial ECG waveforms is no longer required, the precordial ECG electrode array <NUM> can be disconnected from the wireless ECG module <NUM> by again twisting the key twist lock <NUM> inserted into a grooved slot of the external connection port by, for example, <NUM>° in a counter clockwise direction, thereby releasing the connection between the in-line connector <NUM> and the data acquisition module <NUM>.

<FIG> is a side view of the connection between the data acquisition module and the precordial electrode array according to an embodiment of the present disclosure.

The precordial electrode array <NUM> includes a cable <NUM> that terminates with an in-line connector <NUM>. As shown in <FIG>, the in-line connector <NUM> includes a series of electrical contacts <NUM> that are received in the ECG cable port <NUM> of the data acquisition module <NUM>. The ECG cable port <NUM> includes a connector cavity <NUM> having a series of compression contacts <NUM> that align with the series of electrical contacts <NUM> when the in-line connector <NUM> is fully inserted into the connector cavity <NUM> of the data acquisition module <NUM>. When the in-line connector <NUM> is fully inserted into the connector cavity <NUM> of the data acquisition module <NUM>, the in-line connector <NUM> establishes an electrical connection with the embedded circuity (e.g., connections <NUM> to the data acquisition circuit <NUM>) of the data acquisition module <NUM>, which in turn establishes a connection between the precordial electrode array <NUM> and the wireless ECG module <NUM>. This configuration provides the capability of obtaining additional ECG data for diagnostic data similar to the <NUM> lead recording without having to remove the primary electrodes (e.g., <NUM>) of the wireless ECG module <NUM>.

The in-line connector <NUM> also includes an integrated seal <NUM> that is concentric around the ECG cable <NUM> for providing a water tight seal, thereby protecting the integrity of the electrical connection between the data acquisition module <NUM> and the precordial electrode array <NUM> when the in-line connector <NUM> is received in the ECG cable port <NUM> of the data acquisition module <NUM>. Having the seal <NUM> integrated within the ECG cable <NUM> rather than having an O-ring within the connector cavity can improve the reliability of the seal by avoiding a multi-use configuration.

The in-line connector <NUM>, once establishing a connection between the data acquisition module <NUM> and the precordial electrode array <NUM>, is held securely in place using a lock mechanism such as a keyed twist lock <NUM>, which when inserted in the ECG cable port <NUM> of the data acquisition module <NUM> is twisted (e.g., <NUM>°) and aligned within a grooved slot. The In-line connector <NUM> is guided into ECG cable port <NUM> and the connector cavity <NUM> by holding the strain relief portion <NUM> of the in-line connector <NUM>, which prevents damage to the precordial electrode array <NUM> and the cable <NUM>. The strain relief portion <NUM> is integrated into the ECG cable <NUM>, which can also provide additional protection from water ingress.

<FIG> are top views respectively of the adjustable electrodes on the ECG module and the precordial array.

Each patient has a different anatomy (e.g., body size and orientation of heart) and may require monitoring for different cardiac conditions. Therefore, there may be a requirement to adjust the location of each ECG electrode to be application specific for each patient. As shown in <FIG>, this embodiment of the wireless ECG module <NUM> includes a data acquisition module <NUM> composed of a flexible polymer material with embedded circuity and an electrode patch <NUM>. The embedded circuity of the data acquisition module <NUM> includes, for example, the data acquisition circuit <NUM>, microcontroller <NUM>, on-board memory <NUM>, the rechargeable battery <NUM>, and patient alarm <NUM>, as described with reference to <FIG>.

The electrode patch <NUM> of the wireless ECG module <NUM> is composed of, for example, a breathable porous material integrated with a minimal set (e.g., <NUM>) of ECG electrodes <NUM>. In an alternative embodiment, additional ECG electrodes can be added. Additionally, the electrode patch <NUM> can also be composed of silicon, polymer, foam, cloth, or similar material. As shown in <FIG>, the electrode patch <NUM> includes adjustable electrodes slots <NUM>. The location of each ECG electrodes <NUM> can be adjusted within each of electrode slots <NUM> in the electrode patch <NUM>. For example, one potential method to adjust each ECG electrode <NUM> would be to provide an adjustment to each ECG electrode <NUM> within its corresponding adjustable electrode slot <NUM> and relying on the compression of the flexible polymer of the electrode patch <NUM> around the body of the ECG electrodes <NUM> or an electrode adhesive to maintain stability.

As shown in <FIG>, this embodiment of the precordial electrode array <NUM> includes adjustable electrode slots <NUM>. The precordial electrode array <NUM> is composed of, a breathable porous material integrated with the electrodes <NUM> (e.g., <NUM> or more electrodes). However, the precordial electrode array <NUM> can also be composed of silicon, polymer, foam, cloth, or similar material. The location of each ECG electrode <NUM> can be adjusted within its corresponding electrode slot <NUM> in the precordial electrode array <NUM>. For example, each ECG electrode <NUM> can be adjusted within its corresponding adjustable electrode slot <NUM> by relying on the compression of the flexible polymer of the around the body of the ECG electrodes <NUM> or an electrode adhesive to maintain stability.

<FIG> show an embodiment of the present disclosure in which the ECG data acquisition module <NUM> is integrated with the electrode patch <NUM> such that the entire ECG wireless device <NUM> is disposable. The wireless ECG module <NUM> is composed of, for example, a breathable porous material integrated with a minimal set (e.g., <NUM>) of ECG electrodes <NUM>. In an alternative embodiment, additional ECG electrodes can be added. Additionally, the wireless ECG module <NUM> also be composed of silicon, polymer, foam, cloth, or similar material.

As shown in <FIG>, the electrodes <NUM> are located on the outer periphery of the electrode patch <NUM> with a bottom surface of the electrodes configured to come into contact with the patient's skin. In this embodiment, the ECG data acquisition module <NUM> and the electrode patch <NUM> are disposable, and the data acquisition module <NUM> of wireless ECG module <NUM> includes embedded circuity <NUM>. The embedded circuity includes, for example, the data acquisition circuit <NUM>, microcontroller <NUM>, on-board memory <NUM>, the rechargeable battery <NUM>, and patient alarm <NUM>, as described with reference to <FIG>.

As shown in <FIG>, electrical connection is establish between electrodes <NUM> of the electrode patch <NUM> and the embedded circuity <NUM> by wires or a flexible circuit <NUM> embedded in the wireless ECG module <NUM>. The electrical connection allows for ECG signals from the ECG electrodes <NUM> to be transmitted to the embedded circuit <NUM> of the ECG data acquisition module <NUM>.

The embodiment of <FIG> of the wireless ECG module <NUM> can simplify the interconnection design and would eliminate the requirement for a rechargeable power source (i.e. having to swap out between two ECG data acquisition modules). From a clinical perspective, a totally disposable device can improve the patient's outcome by reducing the risk of infection which at times may be caused from improper cleaning methods associated with reusable devices.

<FIG> is a diagram of a physiological monitoring system including the precordial electrode array connected to the main module according to an embodiment of the present disclosure.

The physiological monitoring system of <FIG> differs from the physiological monitoring system of <FIG> in that the precordial electrode array (or set) <NUM> is connected to the main module <NUM> instead of being connected to the wireless ECG module <NUM>. The precordial electrode array <NUM> (e.g., <NUM> or more electrodes) can be placed over the precordial locations of the right and left chest proximate to the ECG wireless module <NUM>. The precordial electrode array <NUM> is composed of a breathable porous material integrated with the electrodes <NUM>. However, the precordial electrode array <NUM> can also be composed of silicon, polymer, foam, cloth, or similar material.

The precordial electrode array <NUM> is attached to the patient using, for example, a biocompatible adhesive or an adhesive surface on the bottom surface of the precordial electrode array <NUM> facing the patient's skin. However, the precordial electrode array <NUM> can be made from a material that is self-adhesive.

The precordial electrode array <NUM> is connected to the main module <NUM> by a cable <NUM> inserted into an external connection port (e.g., cable port) in the main module <NUM>. The precordial electrode set <NUM> includes a cable <NUM> that terminates with an in-line connector. The in-line connector is received in the external connection port of the main module <NUM>, thereby establishing a connection between the precordial electrode array <NUM> and the circuity of the main module <NUM>. This configuration provides the capability of obtaining additional ECG data for a diagnostic data similar to the <NUM> lead recording without having to remove the primary electrodes (e.g., <NUM>) of the wireless ECG module <NUM>. Once the additional <NUM> lead ECG data is obtained, the precordial electrode array <NUM> can be disconnected after it is determined that the additional diagnostic ECG data is no longer required.

The cable <NUM> between the precordial electrode set <NUM> and the main module <NUM> is, for example, an electrical cable or other similar interface cable. Once attached, the electrical signals from the electrodes <NUM> of the precordial electrode array <NUM> are received by the main module <NUM>, the data signals are processed by the circuity of the main module <NUM> as described previously with reference to <FIG> and <FIG>.

For example, the data signals from the electrodes <NUM> are input to an ECG data acquisition circuit <NUM>, which includes amplifying circuitry, filtering circuity, and A/D circuity that convert the analog signals to digital signals using amplification, filtering, and A/D conversion methods known in the art. The processing of the ECG data signals by the ECG data acquisition circuit <NUM> produces digital data waveforms, which are passed to a microcontroller <NUM>, which analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller <NUM> can identify any abnormal cardiac conditions (e.g. arrhythmias, or ST segment measurements indicative of ischemia or myocardial infarction).

Additionally, the microcontroller <NUM> includes communication interface circuitry for establishing communication connections with various devices and networks using both wired and wireless connections for transmitting physiological data, results of the analysis by the microcontroller <NUM>, and alerts and/or alarms to the patient, clinicians and caregivers regarding any abnormal conditions detected as well as storing the physiological data in the on-board memory <NUM>.

<FIG> is a side view of the connection between the main module and the precordial electrode array according to an embodiment of the present disclosure.

The precordial electrode array <NUM> includes a cable <NUM> that terminates with an in-line connector <NUM>. As shown in <FIG>, the in-line connector <NUM> includes a series of electrical contacts <NUM> that are received in the cable port <NUM> of the main module <NUM>. The cable port <NUM> includes a connector cavity <NUM> having a series of compression contacts <NUM> that align with the series of electrical contacts <NUM> when the in-line connector <NUM> is fully inserted into the connector cavity <NUM> of the main module <NUM>. When the in-line connector <NUM> is fully inserted into the connector cavity <NUM> of the main module <NUM>, the in-line connector <NUM> establishes an electrical connection with the circuity of the main module <NUM>.

The in-line connector <NUM> also includes an integrated seal <NUM> that is, for example, concentric around the ECG cable <NUM> for providing a water tight seal, thereby protecting the integrity of the electrical connection between the and the precordial electrode array <NUM> and the main module <NUM> when the in-line connector <NUM> is received in the cable port <NUM>. Having the seal <NUM> integrated within the ECG cable <NUM> rather than having an O-ring within the connector cavity <NUM> can improve the reliability of the seal <NUM> by avoiding a multi-use configuration.

The in-line connector <NUM>, once establishing a connection between the main module <NUM> and the precordial electrode array <NUM>, is held securely in place using a lock mechanism such as a keyed twist lock <NUM>. The keyed twist lock <NUM> is inserted in the ECG cable port <NUM> of the main module <NUM> and then twisted (e.g., <NUM>°) and aligned within a grooved slot (e.g., in the connector cavity). The In-line connector <NUM> is guided into cable port <NUM> and the connector cavity <NUM> (i.e., for establishing a connection between the main module <NUM> and the precordial electrode array <NUM> by holding a strain relief portion <NUM> of the in-line connector <NUM>, which prevents damage to the precordial electrode array <NUM> and the cable <NUM>. The strain relief portion <NUM> is integrated into the ECG cable <NUM>, which can also provide additional protection from water ingress.

The subject matter described in the present disclosure of the present application provides many technical improvements over conventional patient monitoring devices and systems that includes, for example, improved outcomes of patients during ambulatory activity associated with their recuperation and rehabilitation by providing a simplified ECG electrode placement, a detachable precordial electrode array, wireless communications between product subsystems which eliminates wires between ECG electrodes and physiological monitor, and improved performance with respect to noise immunity and reliability.

Technical improvements over conventional patient monitoring devices and systems also include interconnections of the electrode array to the main module and the wireless ECG electrode array, which can be configured with an in-line connection. Additionally, the electrode array and the wireless ECG module have the capability to adjust individual electrode locations which could allow for application specific cardiac vectors to each patient. Moreover, the wireless ECG module can include disposable components and circuitry.

The present disclosure may be implemented as any combination of an apparatus, a system, an integrated circuit, and a computer program on a non-transitory computer readable recording medium. The microcontrollers may be implemented as an integrated circuit (IC), an application specific integrated circuit (ASIC), or large scale integrated circuit (LSI), system LSI, super LSI, or ultra LSI components which perform a part or all of the functions of the wireless ECG module and main module.

Each of the components of the wireless ECG module and the main module of the present disclosure can be implemented using many single-function components, or can be one component integrated using the technologies described above. The various illustrative circuits and modules described in connection with the disclosure herein may be implemented or performed with a general-purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. A processor may in some cases be in electronic communication with a memory, where the memory stores instructions that are executable by the processor.

The present disclosure includes the use of computer programs or algorithms in the wireless ECG module and the main module. The programs or algorithms can be stored on a non-transitory computer-readable medium for causing a computer, such as the microcontroller, to execute the steps described in <FIG> and <FIG>. The computer programs, which can also be referred to as programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor, and can be implemented in a high-level procedural language, an object-oriented programming language, a functional programming language, a logical programming language, or an assembly language or machine language. The term computer-readable recording medium refers to any computer program product, apparatus or device, such as a magnetic disk, optical disk, solid-state storage device, memory, and programmable logic devices (PLDs), used to provide machine instructions or data to a programmable data processor, including a computer-readable recording medium that receives machine instructions as a computer-readable signal.

By way of example, computer-readable medium can comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired computer-readable program code in the form of instructions or data structures and that can be accessed by a general-purpose or special-purpose computer, or a general-purpose or special-purpose processor. Disk or disc, as used herein, include compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers.

The subject matter of the disclosure of the present application are merely provided as examples of patient monitoring devices and systems. Further features or variations are contemplated in addition to the features of the patient monitoring apparatus and systems described above. It is contemplated that the implementation of the components of the present disclosure can be done with any newly arising technology that may replace any of the above implemented technologies.

The above description provides examples, and is not limiting of the scope, applicability, or configuration set forth in the claims. Various embodiments may omit, substitute, or add various procedures or components as appropriate. For instance, features described with respect to certain embodiments may be combined in other embodiments.

Claim 1:
A physiological monitoring system for providing monitoring of a patient, comprising:
an electrocardiogram (ECG) module (<NUM>) including an ECG microcontroller (<NUM>, <NUM>, <NUM>) and a first plurality of electrodes (<NUM>) worn on the patient, the ECG microcontroller (<NUM>, <NUM>, <NUM>) being coupled to the first plurality of electrodes (<NUM>) for receiving first physiological data gathered by the first plurality of electrodes (<NUM>);
a main module (<NUM>) detachably worn by the patient and connected to the ECG module by a wireless communication connection (<NUM>), the main module including a main controller, an on-board memory (<NUM>, <NUM>), and a communication interface coupled to the main controller, wherein:
the ECG microcontroller (<NUM>, <NUM>, <NUM>) being configured to:
analyze the first physiological data,
identify a first abnormal condition of the patient based on the analyzed first physiological data,
determine a first significant physiological event based on the identified first abnormal condition of the patient,
on determining the first significant physiological event, generate one or more of an alarm signal and an alert signal and transmit the one or more of the alarm signal and the alert signal to an internal alarm of the electrocardiogram module,
transmit to the main controller (<NUM>) in real-time, using the wireless communication connection, data corresponding to the first significant physiological event;
the main controller being configured to:
receive the data corresponding to the first significant physiological event from the ECG module using the wireless communication connection (<NUM>);
transmit in real-time, using a first wireless communication protocol, data corresponding to the first significant physiological event,
the communication interface including the first wireless communication protocol and a second wireless communication protocol different from the first wireless communication protocol, the communication interface configured for establishing communication connections with various devices and networks using both wired and wireless connections, the communication interface configured to transmit physiological data, transmit information regarding physiological events and abnormal conditions, and signal alerts and alarms related to physiological data, physiological events, and abnormal conditions.