Patent Application
20200268250
The subject matter of the present disclosure relates generally to patient monitoring devices used for collecting physiological data.
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 24 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.
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.
As shown in
The data signals related to NIBP, temperature, and eTCO2 are received from a detachable physiological sensors 10 connected to the main module 7 through an external physiological parameter interface 11. The external physiological parameter interface 11 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 9, the SpO2 data acquisition circuit 8, and external physiological parameter interface 11 produces digital data waveforms, which are passed to a dedicated microcontroller 12 by electrical connection therebetween. The digital data waveforms are analyzed by the microcontroller 12 to identify any abnormal conditions of the patient. The microcontroller 12 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 12 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 12 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 12 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 1, 3, and 10 to identify abnormal conditions of the patient.
The results of the analysis by the microcontroller 12 are passed to the microcontroller 13 by an electrical connection between the microcontrollers 12, 13. The microcontroller 13 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 13 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 13 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 12, and alerts and/or alarms to the patient, clinicians and caregivers regarding any abnormal conditions detected. Additionally, the memory in the microcontroller 13 stores software or algorithms with executable instructions and the microcontroller 13 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
It is also contemplated by the disclosure of the present application that the communication connections established by the microcontroller 13 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., 1.4 GHz). Other wireless communication connections can include wireless connections that operate in accordance with, but are not limited to, IEEE802.11 protocol, a Radio Frequency For Consumer Electronics (RF4CE) protocol, ZigBee protocol, and/or IEEE802.15.4 protocol.
The Bluetooth connection 14 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 7. The Bluetooth connection 14 also provides wireless communications between the main module 7 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 13 of the main module 7 provides communication connection by direct wired (e.g., hard-wired) connections as well for transferring data using, for example, a USB connection 19 to a tablet, PC, or similar electronic device; or using, for example, a USB connection 20 to an external storage device or memory.
Additionally, the microcontroller 13 includes a connection to a graphical user interface (GUI) 21 for displaying information, physiological data, measured data, and/or alerts/alarms to the patient, or to clinicians and caregivers proximate to the main module 7. Although the main module 7 is described in
The GUI 21 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 7.
As shown in
The on-board memory 22 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 7 using a rechargeable battery 4 that can be detached allowing for replacement. The rechargeable battery 4 is, for example, a rechargeable lithium-ion battery. Additionally, a small built-in back-up battery 6 (or super capacitor) is provided for continuous power to main module 7 during battery replacement. A power supply regulation circuit 5 is provided between the rechargeable battery 4 and small back-up battery 6 to control which of batteries 4, 6 provide power to the main module 7. The main module 7 also includes a patient ground connection 2 for providing a reference when acquiring the ECG signals. The patient ground connection 2 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).
In step S1, the microcontroller 12 of the main module 7 receives the digital data waveforms from the ECG data acquisition circuit 9, the SpO2 data acquisition circuit 8, and external physiological parameter interface 11. The memory of the microcontroller 12 has stored in advance digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. In step S2, the microcontroller 12 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 exists, the microcontroller 12 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 exists, then the microcontroller 12 transmits the results of the analysis to the microcontroller 13 of the main module 7 by an electrical connection between the microcontrollers 12, 13.
In step 4, the microcontroller 13 determines if the WIFI connection 17 or the Bluetooth connection 14 is available for transmissions. For example, the microcontroller 13 may determine that the main module 7 is not within transmission range for using the WIFI connection 17 or the Bluetooth connection 14, or determine that the WIFI connection 17 or the Bluetooth connection 14 is not operable. If it is determined by the microcontroller 13 that the WIFI connection 17 or the Bluetooth connection 14 is available, then in step S5 the microcontroller 13 transmits the physiological data and alerts along with other pertinent data using the WIFI connection 17 or the Bluetooth connection 14.
However, in step S4, if it is determined that the WIFI connection 17 or the Bluetooth connection 14 is not available for transmissions, then in step S6 the microcontroller 13 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 13 transmits the physiological data and alerts along with other pertinent data using the cellular connection 16. However, if it is determined that no significant physiological event has been detected, then in step S8 the microcontroller 13 stores the physiological data in the on-board memory 22 for later transmission when the WIFI connection 17 or the Bluetooth connection 14 become available, as determined in steps S4-S5.
As shown in
The processing of the ECG data signals by the ECG data acquisition circuit 26 produces digital data waveforms, which are passed to a microcontroller 28 by electrical connection therebetween. The microcontroller 28 analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller 28 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 28 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 28 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 23 to identify abnormal conditions of the patient.
In step S11, if it is determined that no abnormal condition exists, the microcontroller 28 continues to analyze the physiological data waveforms received, as in step S10. However, in step S11, if it is determined that any abnormal condition exists, then in step S12 the microcontroller 28 transmits the results to the patient in the way of an alert or alarm, and/or transmits the results to the main module 7 via a wireless Bluetooth connection 31.
The memory in the microcontroller 28 stores software or algorithms with executable instructions and the microcontroller 28 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 circuitry of the microcontroller 28.
Referring again to
The microcontroller 28 can also transmit a signal to an internal alarm 29 (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 30 electrically connected to the microcontroller 28. The on-board memory 30 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
As shown in
As shown in
As shown in
The wireless ECG module 15 includes a data acquisition module 41 composed of a flexible polymer material with embedded circuitry and an electrode patch 40. The embedded circuitry of the data acquisition module 41 includes, for example, the data acquisition circuit 26, microcontroller 28, on-board memory 30, the rechargeable battery 27, and patient alarm 29, as described with reference to
The electrode patch 40 of the wireless ECG module 15 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 40 facing the patient's skin. However, the electrode patch 40 can be made from a material that is self-adhesive. As shown in
The ECG data signals from the electrodes 23 are received by the data acquisition module 41, and processed by the embedded circuitry as described previously with reference to
The processing of the ECG data signals by the ECG data acquisition circuit 26 produces digital data waveforms that are passed to a microcontroller 28, which analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller 28 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 exists, then the microcontroller 28 transmits the results to the patient in the way of an alert or alarm, and/or transmits the results to the main module 7 via the wireless communication link 42. When transmitting an alert or alarm to the patient, the microcontroller 28 transmits a signal to the internal alarm 29 using, for example, a vibratory response directly to the patient's skin. When the results are transmitted to the main module 7 via the wireless communication link 42, the microcontroller 13 of the main module 7 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 22, as described previously with reference to
The physiological monitoring system of
As shown in
The cable 50 between the precordial electrode set 53 and the wireless ECG module 15 is, for example, an electrical cable or other similar interface cable. Once attached, the electrical signals from the electrodes 52 of the precordial electrode array 53 are received by the data acquisition module 41 of the wireless ECG module 15, and the data signals are processed by the embedded circuitry as described previously with reference to
For example, the data signals from the electrodes 52 are input to an ECG data acquisition circuit 26, which includes amplifying circuitry, filtering circuitry, and A/D circuitry 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 26 produces digital data waveforms that are passed to a microcontroller 28, which analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller 28 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 exists, then the microcontroller 28 transmits the results to the patient in the way of an alert or alarm, and/or transmits the results to the main module 7 via the wireless communication link 42. When transmitting an alert or alarm to the patient, the microcontroller 28 transmits a signal to the internal alarm 29 using, for example, a vibratory response directly to the patient's skin. When the results are transmitted to the main module 7 via the wireless communication link 42, the microcontroller 13 of the main module 7 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 22, as described previously with reference to
As shown in
The electrode patch 40 of the wireless ECG module 15 is composed of, a breathable porous material integrated with a minimal set (e.g., 3) of ECG electrodes 23, similar to 3 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 41 can be a reusable device and detachably connected to the electrode patch 40, whereas the electrode patch 40 (including the electrodes) is disposable. The ECG electrode patch 40 is composed of a material that is a flexible porous structure to allow the patient's skin to “breathe.” The ECG data acquisition module 41 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 15. The polymer can also be flexible to allow the wireless ECG module 15 to conform to the patient's body. Once the ECG data acquisition module 41 is attached to a new electrode patch 40, the three (3) electrodes are connected underneath the ECG electrode patch by flexible circuitry to the data acquisition module 41 for detecting the ECG voltage signals.
When the patient is within a higher acuity level of physiological monitoring, there can still be a requirement to obtain a 12 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 3 lead configuration, to attach electrodes for a separate 12 lead ECG recorder. Under such conditions, a separate precordial ECG electrode array 53 can be attached directly to the patient and the wireless ECG module 15 using the cable port 70 in the data acquisition module 41 for providing additional ECG recordings in precordial locations during the higher acuity monitoring. The precordial electrode set 53 includes a cable 50 that terminates with an in-line connector 51. The in-line connector 51 is received in the ECG cable port 70 of the data acquisition module 41, which establishes an electrical connection with the embedded circuitry (e.g., connections 33 to the data acquisition circuit 26), thereby also establishing a connection between the precordial electrode array 53 and the wireless ECG module 15.
The ECG electrode array 53 can also be used during cardiac rehabilitation activities to monitor the 12 lead ECG signal. Once the requirement for obtaining the precordial ECG waveforms is no longer required, the precordial ECG electrode array 53 can be disconnected from the wireless ECG module 15 by disconnecting the in-line connector 51 of the cable 50 from the ECG cable port 70 of the wireless ECG module. The precordial electrode array 53 can be removed from the patient leaving the primary 3 lead ECG patch 40 of the wireless ECG module 15 attached for additional continuous 24 hour (or greater) monitoring.
In another embodiment of the ECG electrode patch 40 of the ECG wireless module 15, the ECG electrode patch 40 can include additional electrodes (e.g. 5 or more) embedded within a flexible polymer insulation for detecting the ECG voltage signal as a precordial ECG electrode array.
As shown in
In order to protect against water ingress to the electrical connection between the data acquisition module 41 and the electrode patch 40, there is an O-ring seal 81 around the electrical connectors 80 and positioned between the bottom surface of the data acquisition module 41 and the top surface of the ECG electrode patch 40.
As shown in
The electrical connectors 80 are, for example, male electrical connectors (e.g., 3) that establish an electrical connection with the electrodes 23 of the electrode patch 40 coming in contact with the wires or flexible circuit 84 embedded in the electrode patch 40. It is contemplated by the disclosure of the present application that the connectors used for establishing connections between the data acquisition module 41 and the electrode patch 40 can be male or female connectors or a combination of male and female connectors.
A separate precordial ECG electrode array 53 can be attached directly to the patient and the wireless ECG module 15 using the cable port 70 in the data acquisition module 41 for providing additional ECG recordings in precordial locations during the higher acuity monitoring. The precordial electrode array 53 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 53 facing the patient's skin. However, the precordial electrode array 53 can be made from a material that is self-adhesive. The precordial electrode array 53 is connected to the primary set of electrodes (e.g., 3 electrodes) of the wireless ECG module 15 through an external connection port (e.g., ECG cable port) in the data acquisition module 41.
The precordial electrode array 53 is composed of a breathable porous material integrated with the electrodes 52 (e.g., 5 or more electrodes). However, the precordial electrode array 53 can also be composed of silicon, polymer, foam, cloth, or similar material. As shown in
The in-line connector 51 also includes a seal 92 that is concentric around the ECG cable 50 for providing a water tight seal, thereby protecting the integrity of the electrical connection between the data acquisition module 41 and the precordial electrode array 53 when the in-line connector is received in the external connection port (e.g., ECG cable port 70) of the data acquisition module 41. Having the seal 91 integrated within the ECG cable 50 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 51, once establishing a connection between the data acquisition module 41 and the precordial electrode array 53, is held securely in place using a lock mechanism such as a keyed twist lock 91. When the keyed twist lock 91 is inserted in the external connection port of the data acquisition module 41, the keyed twist lock 91 is twisted (e.g., 90° in the clockwise direction) and aligned within a grooved slot (e.g., in the external connection port). The In-line connector 51 is guided into place in the external connection port of the data acquisition module 41 by holding the strain relief portion 90 of the in-line connector 51, which prevents damage to the precordial electrode array 53 and the cable 50. The strain relief portion 90 is integrated into the ECG cable 50, which can also provide additional protection from water ingress.
The ECG electrode array 53 can be used during cardiac rehabilitation activities to monitor the 12 lead ECG signal. Once the requirement for obtaining the precordial ECG waveforms is no longer required, the precordial ECG electrode array 53 can be disconnected from the wireless ECG module 15 by disconnecting the in-line connector 51 of the cable 50 from the ECG cable port 70 of the wireless ECG module 15. The precordial electrode array 53 can be removed from the patient leaving the primary 3 lead ECG patch 40 of the wireless ECG module 15 attached for additional continuous 24 hour (or greater) monitoring.
The in-line connector 51, once in place and establishing a connection between the data acquisition module 41 and the precordial electrode array 53, is held securely in place using an integrated keyed twist lock 91.
As shown in
The precordial electrode array 53 includes a cable 50 that terminates with an in-line connector 51. As shown in
The in-line connector 51 also includes an integrated seal 92 that is concentric around the ECG cable 50 for providing a water tight seal, thereby protecting the integrity of the electrical connection between the data acquisition module 41 and the precordial electrode array 53 when the in-line connector 51 is received in the ECG cable port 70 of the data acquisition module 41. Having the seal 92 integrated within the ECG cable 50 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 51, once establishing a connection between the data acquisition module 41 and the precordial electrode array 53, is held securely in place using a lock mechanism such as a keyed twist lock 91, which when inserted in the ECG cable port 70 of the data acquisition module 41 is twisted (e.g., 90°) and aligned within a grooved slot. The In-line connector 51 is guided into ECG cable port 70 and the connector cavity 98 by holding the strain relief portion 90 of the in-line connector 51, which prevents damage to the precordial electrode array 53 and the cable 50. The strain relief portion 90 is integrated into the ECG cable 50, which can also provide additional protection from water ingress.
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
The electrode patch 40 of the wireless ECG module 15 is composed of, for example, a breathable porous material integrated with a minimal set (e.g., 3) of ECG electrodes 23. In an alternative embodiment, additional ECG electrodes can be added. Additionally, the electrode patch 40 can also be composed of silicon, polymer, foam, cloth, or similar material. As shown in
As shown in
As shown in
As shown in
The embodiment of
The physiological monitoring system of
The precordial electrode array 53 is attached to the patient using, for example, a biocompatible adhesive or an adhesive surface on the bottom surface of the precordial electrode array 53 facing the patient's skin. However, the precordial electrode array 53 can be made from a material that is self-adhesive.
The precordial electrode array 53 is connected to the main module 7 by a cable 120 inserted into an external connection port (e.g., cable port) in the main module 7. The precordial electrode set 53 includes a cable 120 that terminates with an in-line connector. The in-line connector is received in the external connection port of the main module 7, thereby establishing a connection between the precordial electrode array 53 and the circuitry of the main module 7. This configuration provides the capability of obtaining additional ECG data for a diagnostic data similar to the 12 lead recording without having to remove the primary electrodes (e.g., 3) of the wireless ECG module 15. Once the additional 12 lead ECG data is obtained, the precordial electrode array 53 can be disconnected after it is determined that the additional diagnostic ECG data is no longer required.
The cable 120 between the precordial electrode set 53 and the main module 7 is, for example, an electrical cable or other similar interface cable. Once attached, the electrical signals from the electrodes 52 of the precordial electrode array 53 are received by the main module 7, the data signals are processed by the circuitry of the main module 7 as described previously with reference to
For example, the data signals from the electrodes 52 are input to an ECG data acquisition circuit 9, which includes amplifying circuitry, filtering circuitry, and A/D circuitry 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 9 produces digital data waveforms, which are passed to a microcontroller 12, which analyzes the digital waveforms to identify certain digital waveform characteristics and threshold levels indicative of abnormal conditions of the patient. The microcontroller 12 can identify any abnormal cardiac conditions (e.g. arrhythmias, or ST segment measurements indicative of ischemia or myocardial infarction).
Additionally, the microcontroller 13 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 12, 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 22.
The precordial electrode array 53 includes a cable 120 that terminates with an in-line connector 138. As shown in
The in-line connector 138 also includes an integrated seal 135 that is, for example, concentric around the ECG cable 120 for providing a water tight seal, thereby protecting the integrity of the electrical connection between the and the precordial electrode array 53 and the main module 7 when the in-line connector 138 is received in the cable port 137. Having the seal 135 integrated within the ECG cable 120 rather than having an O-ring within the connector cavity 130 can improve the reliability of the seal 135 by avoiding a multi-use configuration.
The in-line connector 138, once establishing a connection between the main module 7 and the precordial electrode array 53, is held securely in place using a lock mechanism such as a keyed twist lock 132. The keyed twist lock 132 is inserted in the ECG cable port 137 of the main module 7 and then twisted (e.g., 90°) and aligned within a grooved slot (e.g., in the connector cavity). The In-line connector 138 is guided into cable port 137 and the connector cavity 130 (i.e., for establishing a connection between the main module 7 and the precordial electrode array 53 by holding a strain relief portion 136 of the in-line connector 138, which prevents damage to the precordial electrode array 53 and the cable 120. The strain relief portion 136 is integrated into the ECG cable 120, 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 general-purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. 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
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. Combinations of the above are also included within the scope of computer-readable media.
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. Changes may be made in the function and arrangement of elements discussed without departing from the spirit and scope of the disclosure. 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.
The previous description of the disclosure is provided to enable a person skilled in the art to make or use the disclosure. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the spirit or scope of the disclosure. Throughout this disclosure the term “example” indicates an example or instance and does not imply or require any preference for the noted example. Thus, the disclosure is not to be limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US18/52803 | 9/26/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62564104 | Sep 2017 | US |
