ABSTRACT
Abstract
A system for cardiac monitoring of an individual. The system includes a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes arranged on the garment to record data for an ECG of the individual; a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data; and a wireless receiving station including a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter, analyze the recorded data for the ECG, analyze the recorded data, identify an abnormality in the ECG, and generate an alert if an abnormality in the ECG is identified.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. patent application Ser. No. 13/449,755 filed Apr. 18, 2012, which is incorporated by reference herein in its entirety.
BACKGROUND
The present invention relates to a physiological monitoring garment.
Heart related ailments like coronary heart diseases, cardiovascular diseases, and strokes that are caused by clots or hypertension are the predominant causes of mortality in the US among both men and women. However, the number of deaths due to cardiac ailments in women has been consistently higher than in men since as early as 1985. In 2006, mortality due to all cardiac ailments among women was nearly 60% more than that due to all forms of cancer combined. This difference is also imminent in the case of post operative survival among women after major cardiac surgeries like coronary bypass. At age 40 and older, 23 percent of women compared with 18 percent of men die within one year after a heart attack. This statistic has been related to the post-menopausal hormonal changes like the levels of estrogen in the blood. Estrogen has been known to have a prophylactic effect on the formation and growth of arterial plaques and clots, which can stifle the flow of blood through major blood vessels or stop it altogether. However, administration of Estrogen and Progestin has been shown to have minimal effect on the outcome of cardiovascular diseases in post-menopausal women.
Chronic diseases such as asymptomatic myocardial ischemia, a decrease in blood supply to the heart, appear as episodic events that do not leave any diagnostic evidence behind, making them all the more difficult to identify. Detection of Cardiac arrhythmias or irregular beats from continuous electroencephalogram (ECG) recordings is an important metric that physicians use to adjust medication for post myocardial infarction patients.
The major risk factors that have been reported to affect the cardiac health of women are smoking, inactivity, obesity, diabetes mellitus and hormonal changes resulting from menopause. Subtle changes in the cardiac activity manifested as irregular heartbeats, aberrational variations in the body's autonomous regulation of blood pressure and minor transient blockages in flow of blood to the heart, due to such chronic conditions or risk factors lead to fatal cardiac episodes. Thus, the best recourse is to engage in preventive measures involving continuous real-time monitoring to better track these physiological changes. Moreover, techniques like Electrocardiograph (ECG), blood pressure, heart rate variability analysis through time, frequency and wavelet domain analysis techniques have been successful in tracking the above-mentioned subtle changes.
More generally, vigorous exercise and exertion is known to increase the risk of Sudden Cardiac Death (SCD) in both men and women, including youths as well as adults, with underlying cardiovascular diseases (CVD). Recently, SCDs have been reported with a high rate of occurrence among athletes in soccer, football and basketball. Prescreening athletes with 12-lead Electrocardiograms (ECG) has been a successful measure to identify individuals at high risk for SCDs and exclude them from participation. The total cost for such prescreening of athletes is estimated to be in the order of $10 B/year. The high risk of SCDs during training or exertion suggests that ECGs are of far greater value when acquired real-time during the actual training where abnormal cardiac electrophysiology can be tracked and identified before the onset of symptoms. The availability of such immediate diagnostic data would also significantly reduce the time taken to administer the appropriate resuscitation shock. What is needed is method for obtaining cardiovascular information in an unobtrusive manner so that participants in high-stress activities can be continuously monitored for abnormalities.
SUMMARY
Accordingly, disclosed herein are embodiments of a wearable remote electrophysiological monitoring system which includes a fully wearable textile integrated real-time ECG acquisition system with wireless transmission of data for the continuous monitoring of football players during training and on the field during games. The system is applicable also to basketball players, soccer players and other athletes, as well as members of high-stress occupations such as military personnel, police, firefighters, and various other emergency responders.
To that end, the sensors required to pick up the necessary biological signals and constantly relay the signals need to be seamlessly integrated into everyday clothing such that no additional preparation or mounting of individual sensors is needed. The innovative âe-braâ described here is a foundation garment or a brassiere, designed with a multitude of sensor capabilities for cardiac and pulmonary health monitoring which are integrated into a fabric with improved performance. The end result is an autonomous garment that can collect and transmit vital health signals of the wearer.
The e-bra will also help non-critical users (i.e. those not acutely suffering from a condition such as heart or pulmonary diseases) for monitoring important metrics such as calories burned during a workout, to get an optimum workout by jogging or on a treadmill, and pacing their exercise. For instance, the wearer's heart rate should be at the proper intensity level for an extended period of time. If the heart rate gets too high, the wearer's activity can become counterproductive. If it is too low, the wearer is not getting optimal health benefits. This technology will thus monitor and provide the optimum workout needed for a given individual.
The e-bra system described here is a comfortable and wearable monitor for cardiovascular and pulmonary health for women. It has a basic structure of a foundation garment for woman's bosom that covers all or part of chest, shoulders, arms and upper back. Sensor components include biopotential electrodes like electrocardiogram (ECG) electrodes which are mounted on the garment, photoplethysmography channels which are worn as an arm band, piezoelectric acoustic sensors, temperature sensors, and piezoresistive respiration effort sensors.
This technology also provides additional benefits even if one is not a cardiovascular or pulmonary patient. For example, individuals could use the devices to report beneficial activities (exercising, taking medications, sleeping) and receive incentives from partners (doctors, insurance companies, social networks) with whom they share that information.
Thus, in one embodiment the invention provides a wearable remote electrophysiological monitoring system. The system includes a garment having at least one nanostructured, textile-integrated electrode attached thereto; a control module in electrical communication with the at least one nanostructured, textile-integrated sensor; and a remote computing system in communication with the control module.
In another embodiment, the invention provides a system for cardiac monitoring of an individual. The system includes a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes arranged on the garment to record data for an ECG of the individual; a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data; and a wireless receiving station including a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter, analyze the recorded data for the ECG, analyze the recorded data, identify an abnormality in the ECG, and generate an alert if an abnormality in the ECG is identified.
In yet another embodiment, the invention provides a system for cardiac monitoring of a group of individuals including a plurality of wearable monitoring units. Each wearable monitoring unit includes a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes being arranged on the garment to record data for an ECG of the individual; a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data. The system also includes at least one wireless receiving station including a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter and to analyze the recorded data for the ECG, the second controller further configured to analyze the recorded data, identify an abnormality in the ECG, and generate an alert if an abnormality in the ECG is identified.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the invention can become more fully understood from the detailed description given herein below and the accompanying drawings, given by way of illustration only and thus not intended to be limitative of the present invention.
FIG. 1( a ) shows lead placement for a twelve-lead ECG with derived limb leads.
FIG. 1( b ) illustrates the placement of electrodes on the frontal side of the garment in which the electrodes have been placed according to the medical specifications for the limb leads, precordial leads, chest lead, and ground lead.
FIG. 1( c ) illustrates the mounting of an electrode on elastic backing using stitching.
FIG. 2 illustrates the back electrode site and the elastic backings provided in the brassiere platform where the elastic backings facilitate the ECG electrodes maintaining contact with the skin.
FIG. 3 shows the position for the acoustic sensor(s), respiration effort sensor and temperature sensor(s).
FIG. 4 shows the back side of a complete brassiere system, with an extended left arm sleeve that can be detached, with the inset showing a photoplethysmography module.
FIG. 5( a ) shows a scanning electron image of gold nanowires such as those used in embodiments of the nanostructure-based electrodes.
FIG. 5( b ) shows gold nanostructure-containing electrodes mounted on a standard snap-on button.
FIG. 5( c ) shows conductive fabric incorporating a textile electrode which includes nanostructures.
FIG. 6 shows a block diagram of an embodiment of the system.
FIG. 7 shows nanostructures projecting from a fiber.
FIG. 8 shows statistics on cardiac related mortalities in females as compared to females in the United States: 1976-2006.
FIG. 9( a ) shows placement of electrodes for ECG lead 2 .
FIG. 9( b ) shows an ECG waveform with characteristic P wave, QRS complex, and T and U waves.
FIG. 10 shows an e-bra worn by a test subject, the control module, and the smartphone display interface.
FIG. 11( a ) shows the electrode positions on the e-bra.
FIG. 11( b ) shows data acquired from subject 1 .
FIG. 11( c ) shows data acquired from subject 2 .
FIG. 12 shows R-R interval determination from an ECG.
FIG. 13( a ) shows a plot of the RR interval series against beat number.
FIG. 13( b ) shows a plot of the AR PSD computed from the RRI series for the standing case.
FIG. 14( a ) shows a plot of the RR interval series against beat number.
FIG. 14( b ) shows a plot of the AR PSD computed from the RRI series for the standing case.
FIG. 15 shows the sequence of processes and steps followed by the cloud server when an emergency abnormal condition reflected by abnormal health data is detected.
FIG. 16 shows the sequence of processes and steps followed on the mobile device in response to an emergency message sent by the cloud server.
FIG. 17 shows a schematic of the overall implementation of the football player monitoring system.
FIG.
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of U.S. patent application Ser. No. 13/449,755 filed Apr. 18, 2012, which is incorporated by reference herein in its entirety.
BACKGROUND
The present invention relates to a physiological monitoring garment.
Heart related ailments like coronary heart diseases, cardiovascular diseases, and strokes that are caused by clots or hypertension are the predominant causes of mortality in the US among both men and women. However, the number of deaths due to cardiac ailments in women has been consistently higher than in men since as early as 1985. In 2006, mortality due to all cardiac ailments among women was nearly 60% more than that due to all forms of cancer combined. This difference is also imminent in the case of post operative survival among women after major cardiac surgeries like coronary bypass. At age 40 and older, 23 percent of women compared with 18 percent of men die within one year after a heart attack. This statistic has been related to the post-menopausal hormonal changes like the levels of estrogen in the blood. Estrogen has been known to have a prophylactic effect on the formation and growth of arterial plaques and clots, which can stifle the flow of blood through major blood vessels or stop it altogether. However, administration of Estrogen and Progestin has been shown to have minimal effect on the outcome of cardiovascular diseases in post-menopausal women.
Chronic diseases such as asymptomatic myocardial ischemia, a decrease in blood supply to the heart, appear as episodic events that do not leave any diagnostic evidence behind, making them all the more difficult to identify. Detection of Cardiac arrhythmias or irregular beats from continuous electroencephalogram (ECG) recordings is an important metric that physicians use to adjust medication for post myocardial infarction patients.
The major risk factors that have been reported to affect the cardiac health of women are smoking, inactivity, obesity, diabetes mellitus and hormonal changes resulting from menopause. Subtle changes in the cardiac activity manifested as irregular heartbeats, aberrational variations in the body's autonomous regulation of blood pressure and minor transient blockages in flow of blood to the heart, due to such chronic conditions or risk factors lead to fatal cardiac episodes. Thus, the best recourse is to engage in preventive measures involving continuous real-time monitoring to better track these physiological changes. Moreover, techniques like Electrocardiograph (ECG), blood pressure, heart rate variability analysis through time, frequency and wavelet domain analysis techniques have been successful in tracking the above-mentioned subtle changes.
More generally, vigorous exercise and exertion is known to increase the risk of Sudden Cardiac Death (SCD) in both men and women, including youths as well as adults, with underlying cardiovascular diseases (CVD). Recently, SCDs have been reported with a high rate of occurrence among athletes in soccer, football and basketball. Prescreening athletes with 12-lead Electrocardiograms (ECG) has been a successful measure to identify individuals at high risk for SCDs and exclude them from participation. The total cost for such prescreening of athletes is estimated to be in the order of $10 B/year. The high risk of SCDs during training or exertion suggests that ECGs are of far greater value when acquired real-time during the actual training where abnormal cardiac electrophysiology can be tracked and identified before the onset of symptoms. The availability of such immediate diagnostic data would also significantly reduce the time taken to administer the appropriate resuscitation shock. What is needed is method for obtaining cardiovascular information in an unobtrusive manner so that participants in high-stress activities can be continuously monitored for abnormalities.
SUMMARY
Accordingly, disclosed herein are embodiments of a wearable remote electrophysiological monitoring system which includes a fully wearable textile integrated real-time ECG acquisition system with wireless transmission of data for the continuous monitoring of football players during training and on the field during games. The system is applicable also to basketball players, soccer players and other athletes, as well as members of high-stress occupations such as military personnel, police, firefighters, and various other emergency responders.
To that end, the sensors required to pick up the necessary biological signals and constantly relay the signals need to be seamlessly integrated into everyday clothing such that no additional preparation or mounting of individual sensors is needed. The innovative âe-braâ described here is a foundation garment or a brassiere, designed with a multitude of sensor capabilities for cardiac and pulmonary health monitoring which are integrated into a fabric with improved performance. The end result is an autonomous garment that can collect and transmit vital health signals of the wearer.
The e-bra will also help non-critical users (i.e. those not acutely suffering from a condition such as heart or pulmonary diseases) for monitoring important metrics such as calories burned during a workout, to get an optimum workout by jogging or on a treadmill, and pacing their exercise. For instance, the wearer's heart rate should be at the proper intensity level for an extended period of time. If the heart rate gets too high, the wearer's activity can become counterproductive. If it is too low, the wearer is not getting optimal health benefits. This technology will thus monitor and provide the optimum workout needed for a given individual.
The e-bra system described here is a comfortable and wearable monitor for cardiovascular and pulmonary health for women. It has a basic structure of a foundation garment for woman's bosom that covers all or part of chest, shoulders, arms and upper back. Sensor components include biopotential electrodes like electrocardiogram (ECG) electrodes which are mounted on the garment, photoplethysmography channels which are worn as an arm band, piezoelectric acoustic sensors, temperature sensors, and piezoresistive respiration effort sensors.
This technology also provides additional benefits even if one is not a cardiovascular or pulmonary patient. For example, individuals could use the devices to report beneficial activities (exercising, taking medications, sleeping) and receive incentives from partners (doctors, insurance companies, social networks) with whom they share that information.
Thus, in one embodiment the invention provides a wearable remote electrophysiological monitoring system. The system includes a garment having at least one nanostructured, textile-integrated electrode attached thereto; a control module in electrical communication with the at least one nanostructured, textile-integrated sensor; and a remote computing system in communication with the control module.
In another embodiment, the invention provides a system for cardiac monitoring of an individual. The system includes a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes arranged on the garment to record data for an ECG of the individual; a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data; and a wireless receiving station including a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter, analyze the recorded data for the ECG, analyze the recorded data, identify an abnormality in the ECG, and generate an alert if an abnormality in the ECG is identified.
In yet another embodiment, the invention provides a system for cardiac monitoring of a group of individuals including a plurality of wearable monitoring units. Each wearable monitoring unit includes a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes being arranged on the garment to record data for an ECG of the individual; a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data. The system also includes at least one wireless receiving station including a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter and to analyze the recorded data for the ECG, the second controller further configured to analyze the recorded data, identify an abnormality in the ECG, and generate an alert if an abnormality in the ECG is identified.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the invention can become more fully understood from the detailed description given herein below and the accompanying drawings, given by way of illustration only and thus not intended to be limitative of the present invention.
FIG. 1( a ) shows lead placement for a twelve-lead ECG with derived limb leads.
FIG. 1( b ) illustrates the placement of electrodes on the frontal side of the garment in which the electrodes have been placed according to the medical specifications for the limb leads, precordial leads, chest lead, and ground lead.
FIG. 1( c ) illustrates the mounting of an electrode on elastic backing using stitching.
FIG. 2 illustrates the back electrode site and the elastic backings provided in the brassiere platform where the elastic backings facilitate the ECG electrodes maintaining contact with the skin.
FIG. 3 shows the position for the acoustic sensor(s), respiration effort sensor and temperature sensor(s).
FIG. 4 shows the back side of a complete brassiere system, with an extended left arm sleeve that can be detached, with the inset showing a photoplethysmography module.
FIG. 5( a ) shows a scanning electron image of gold nanowires such as those used in embodiments of the nanostructure-based electrodes.
FIG. 5( b ) shows gold nanostructure-containing electrodes mounted on a standard snap-on button.
FIG. 5( c ) shows conductive fabric incorporating a textile electrode which includes nanostructures.
FIG. 6 shows a block diagram of an embodiment of the system.
FIG. 7 shows nanostructures projecting from a fiber.
FIG. 8 shows statistics on cardiac related mortalities in females as compared to females in the United States: 1976-2006.
FIG. 9( a ) shows placement of electrodes for ECG lead 2 .
FIG. 9( b ) shows an ECG waveform with characteristic P wave, QRS complex, and T and U waves.
FIG. 10 shows an e-bra worn by a test subject, the control module, and the smartphone display interface.
FIG. 11( a ) shows the electrode positions on the e-bra.
FIG. 11( b ) shows data acquired from subject 1 .
FIG. 11( c ) shows data acquired from subject 2 .
FIG. 12 shows R-R interval determination from an ECG.
FIG. 13( a ) shows a plot of the RR interval series against beat number.
FIG. 13( b ) shows a plot of the AR PSD computed from the RRI series for the standing case.
FIG. 14( a ) shows a plot of the RR interval series against beat number.
FIG. 14( b ) shows a plot of the AR PSD computed from the RRI series for the standing case.
FIG. 15 shows the sequence of processes and steps followed by the cloud server when an emergency abnormal condition reflected by abnormal health data is detected.
FIG. 16 shows the sequence of processes and steps followed on the mobile device in response to an emergency message sent by the cloud server.
FIG. 17 shows a schematic of the overall implementation of the football player monitoring system.
FIG. 18 shows components of a wireless ECG monitoring garment system; FIG. 18( a ) shows a compression base layer garment with sensor electrodes and printed traces; FIG. 18( b ) shows protective shoulder pads with snap on connection cables to connect sensors to a wireless module; FIG. 18( c ) shows a wireless module with a 5-channel amplifier and an XBee ZigBee module; and FIG. 18( d ) shows a wireless communication module placed in a pocket on the interior of the shoulder pad.
FIG. 19 shows a schematic of the wireless module.
FIG. 20( a ) shows a schematic of a 3-stage amplifier for use with embodiments of a wireless ECG monitoring garment system; FIG. 20( b ) shows a schematic of a Wilson Central Terminal (WCT) generation circuit.
FIG. 21( a ) shows ECG signals acquired using the system having Lead I and II, precordial leads V1, V2 and V5; FIG. 21( b ) shows Lead III and augmented limb leads derived from signals in FIG. 21( a ).
DETAILED DESCRIPTION
Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.
In various embodiments, the invention includes a wearable remote electrophysiological monitoring system 20 ( FIG. 6 ). The system 100 may include a garment 200 having at least one nanostructured, textile-integrated electrode 205 attached thereto, a control module 300 in electrical communication with the at least one nanostructured, textile-integrated electrode 205 , and a remote computing system 400 in communication with the control module 300 ( FIG. 6 ). The system may also include a plurality of physiological sensors such as a photoplethysmography sensor 210 , an acoustic sensor 215 , a temperature sensor 220 , and a strain sensor 225 ( FIG. 6 ). The acoustic sensor 215 may be attached to the garment 200 to collect acoustic signals from a heart of a wearer of the garment 200 . The temperature sensor 220 may include a resistive temperature detector, a thermistor, and an infrared photodiode detector. The strain sensor 225 may include a piezoresistive respiration effort sensor to monitor breathing of a wearer of the garment 200 . The various physiological sensors may be electrically connected to the control module 300 by silver-coated thread. Each group of electrodes or sensors may have an amplifier module associated therewith, for example attached to the garment 200 in the vicinity of the electrodes or sensors or incorporated into the control module 300 .
The remote computing system 400 may communicate with the control module 300 using radio-frequency communications, for example using short-range communications such as Bluetooth; a local area network (e.g. wi-fi); satellite; or cellular communications technology. The remote computing system 400 may also communicate with the control module 300 using other forms of communications such as infrared light or microwaves. In some embodiments, the remote computing system 400 may communicate with the control module 300 using a wire-based connection or a combination of wired and wireless modalities.
The nanostructured, textile-integrated electrodes 205 may be made of a hierarchically-organized nanostructure sheet with vertically standing nanowires/filaments. The electrodes 205 are generally incorporated in the fabric of the garment 200 with an elastic backing for concomitant contact with the skin.
The nanostructured, textile-integrated electrodes 205 include nanostructures 207 attached to and projecting from electrically- conductive fibers 209 that may be incorporated into a portion of fabric. The nanostructures 207 may project from the fiber 209 to varying lengths ranging from 0.01-10 micrometers, and in one embodiment project from the fiber 209 less than one micrometer. The portion of fabric may then be attached to or otherwise incorporated into the garment 200 and placed into electrical communication with the control module 300 .
The nanostructures 207 projecting from the fiber 209 may have different shapes and form factors and may include one- dimensional nanostructures 207 a , two-dimensional nanostructures 207 b , and/or three-dimensional nanostructures 207 c ( FIG. 7 ). The one- dimensional structures 207 a may include approximately linear structures such as wires or tubes. The two-dimensional structures 207 b may include shapes such as bumps or bubbles. The three-dimensional structures 207 c may include shapes such as helices. The helices are particularly suitable as they have a large surface area available for making contact with a wearer's skin. In some embodiments in which helical structures are employed, a particular handedness of the helices (e.g. left-handed or right-handed) may produce better results such as improved conductivity. The fiber 209 from which the nanostructures 207 project is typically electrically conductive, which may be achieved by using a fiber 209 that is coated with an electrically conductive material (e.g. silver) or by using a fiber 209 that is blended or intertwined with an electrically conductive material (e.g. silver). The nanostructures 207 may be fabricated from a number of different materials such as gold, silver, steel, or textiles. In one embodiment, a piece of fabric having fibers with nanostructures thereon can have a density of between 10,000 and 100,000 nanostructures per square centimeter of fabric.
In various embodiments, the nanostructured, textile-integrated electrodes 205 are used as dry contact sensors, i.e. sensors that do not require a conductive gel or other substance to be used with the electrodes 205 to make electrical contact with the wearer's skin. The base substrate (e.g. fiber 209 ) is flexible and conductive and can be made of metal or metal-textile blend(s) or metal-polymer blend(s). Possible metals that may be used include gold, silver, titanium, platinum, and steel or a steel alloy, and possible textile fabrics that may be used include nylon, silk, Lycra, spandex, polyester, modified celluloses, and cotton.
In various embodiments, the garment 200 may be a brassiere (also referred to as the e-bra), a vest, a shirt, or other garment worn over the upper body. In general the garment 200 is form-fitting in order to ensure sufficient contact of the various sensors with the skin of the wearer. Generally, the garment 200 conforms to the wearer's body and complies with standard sizing/fitting schemes, including, in the case of an e-bra, standard cup size and strap lengths. Suitable materials for making the garment 200 include nylon, silk, Lycra, spandex, polyester, modified celluloses, cotton, and combinations of these and other materials, and in general the garment 200 is washable. As described herein, the garment 200 includes electrodes/sensors incorporated therein and in some embodiments the garment 200 may be supplemented by one or more armbands 200 a ( FIG. 6 ) or other wearable devices for collecting additional data. In various embodiments, the system 20 may be worn underneath the wearer's normal clothing for seamless deployment for monitoring the wearer's cardiovascular health or other health indicators.
In some embodiments, the system 20 includes a plurality of nanostructured, textile-integrated electrodes 205 arranged on the garment to collect an electrocardiogram (ECG) signal from a wearer of the garment 200 ( FIG. 1 ), where the electrodes 205 are located on the garment 200 so as to capture heart activity from different perspectives or positions. Since the electrodes 205 in certain embodiments are textile-based, they can be more readily integrated into the fabric of the garment 200 (e.g. an e-bra).
Although there can be variations in the arrangement of electrodes for measuring an electrocardiogram, the positions used in the embodiment depicted in FIGS. 1( a )- 1 ( c ) are medically classified as (but not limited to): limb leads: Right Arm, Left Arm, and Left Leg; precordial leads V1-V6; chest lead C; ground G; and experimental lead E at the back (shown in FIG. 2) . In one embodiment, the electrodes 205 have conductive fiber-based connections, without using conventional wires, which enable the electrodes to send signals to an on board amplification and transmission system (e.g. which may be integrated into the control module 300 ).
Plethysmography measurements can be obtained from impedance measurements (as opposed to optical-based photoplethysmography measurements disclosed herein) in conjunction with ECG recording. This provides information regarding pulse transit time from ventricular discharge to the passage of the pulse at the brachial artery site, the brachial artery being located in the upper arm. The pulse transit time bears a correlation with the compliance of the brachial artery; therefore, it can be correlated to the blood pressure in the artery, thus accomplishing a unique non-invasive blood pressure measurement in real time on a continuous basis without the need for an inflatable cuff.
The system 20 may also include a plurality of photoplethysmography sensors 210 or channels, which may be integrated into the garment 200 or coupled to an armband 200 a to be worn by the user ( FIG. 6 ). In one embodiment, the photoplethysmography (PPG) channels use combinations of light emitting diodes (LED) 210 a and photo detectors (PD) 210 b ( FIG. 4 , inset) that are mounted on the garment 200 (particularly if the garment includes sleeves) and/or an armband 200 a , where the armband 200 a may be made of a material such as nylon, cotton, Lycra, spandex, neoprene, or other elastomeric fabric or film. The wavelengths of light that are used are generally biocompatible red and infrared. The origin of the observed PPG signals may be due to absorption of the light that is emitted by the LED 210 a or may be the reflection of light from the LED 210 a by blood.
As with impedance-based plethysmography measurements, photoplethysmography measurements can be used to detect pulse waves in the brachial artery. The LEDs 210 a may be arranged in a serial connection and the photo detectors 210 b arranged in a parallel connection. The LED-PD combinations include two LEDs 210 a flanking one PD 210 b ( FIG. 4 , inset) at separations that constitute a solid geometric angle for optimum detection of the reflected or transmitted light from the deep-seated brachial artery. The combination is designated as one channel that is mounted in the transverse sense to the left brachial artery axis (inwards of the left arm). More than one such channel is used to scan the brachial artery. Such a configuration gives a stronger signal, one that is more tolerant to variations in the placement position of the arm band 200 a or sleeve of the garment 200 . As discussed above, the use of an armband 200 a may be an addition to the system 20 for enhancing monitoring capabilities. In some embodiments in which the garment 200 includes sleeves, the photoplethysmography sensors 210 may be attached directly to the garment 200 , in particular to the sleeves.
In those embodiments employing acoustic sensors, the acoustic sensors 215 may be based on a hydrophone pad design. The acoustic sensors 215 may be mounted on the garment 200 (e.g. e-bra) in a position that is suitable for detecting sounds being produced by activity of the heart and/or breathing of the wearer. The signals, recorded through these acoustic sensor 215 systems, are important for diagnosing medical conditions like heart murmur, heart valve activity, respiratory blockages, and subsonic (less than 20 Hertz) and ultrasonic (greater than 20 kilohertz) vibrations of diagnostic value. Piezo-resistive textile-based or textile- integrable strain sensors 225 may be mounted on the garment for detection of thoracic distention towards monitoring the respiration effort and respiration cycle.
In some embodiments, one or more temperature sensors 220 may be mounted on the garment 200 . Temperature sensors 220 may be based on resistive temperature detectors, thermistors, or infrared photodiode detectors. As with other electrodes and sensors described herein, the temperature sensors 220 may have conductive fabric- or thread-based connections, i.e. without traditional wires, that enable them to send signals to an onboard amplification and transmission system (e.g. which may be integrated into the control module 300 ).
In various embodiments, the garment 200 is made of the same material as the textile base for the ECG electrodes. In those embodiments in which the garment 200 includes straps or other connectors, ECG or other electrodes 205 may be placed so as to coincide with the adjustable elastic backings of the straps or other connectors to serve dual purposes, while preserving the overall functionality of the garment 200 ( FIG. 2 ). The connections from the ECG electrodes ( FIG. 1( b )) and photoplethysmography device ( FIG. 4 , inset) are drawn out using fabric-based electrodes made with the same assortment of materials described above. In one embodiment, a garment 200 with a non-standard extended left arm sleeve is provided for accommodating the photoplethysmography band ( FIG. 4 , inset) and an amplifier-transmitter module with power source 211 . The conductive fabric or thread for the conductive fabric- or thread-based connections, which can be made with the same assortment of materials described above, can be stitched on the garment in the form of connective lines that relay the signal from sensors to an onboard amplification-transmission module on a flexible board (e.g. which may be integrated into the control module 300 ) for seamless integration into the garment 200 . The connection scheme can also be optical, which involves enmeshed optical fibers. The gauge of the connective lines is generally a function of the electrical and/or optical ratings of the sensor systems. In various embodiments, the control module 300 can use wireless communication with a remote computing system 400 for data logging and post processing. Given the importance of uninterrupted heart monitoring, the amplifier modules associated with the ECG electrodes of the garment 200 may be equipped to connect to a wired data-logging setup. For example, the amplification circuitry in the amplification modules may include ancillary access points for connecting the respective signal channels to a standard data-logging interface with provisions to one of either a display or a data transmission.
The control module 300 and the remote computing system 400 , among other components, are based on standard computer systems having a microprocessor, memory and data storage, input and output, and wired or wireless networking capabilities. The methods and systems described herein may be implemented using one or more such computer systems working in one or more locations to assemble and disseminate data.
The nanostructures 207 of the nanostructured, textile-integrated electrodes 205 (because of their relatively large surface area) are highly sensitive and accurate. Coupled with a low-power microcontroller and Bluetooth module (using one or more of Zigbee, WiFi, and/or other communication protocols as appropriate), the sensor data can be streamed to commercial off-the-shelf cell phones and handheld devices.
In various embodiments the system 20 may include a software application for operation on a smartphone 410 ( FIG. 6 ). The smartphone 410 , via the software application, can collect sensor data over Bluetooth or other communications channels and can relay data over 3G, Wi-Fi, WiMax or any outgoing connection using radio-based communications. Using the smartphone 410 and software application, the system 20 does not require any additional custom handheld device for relaying data.
In various embodiments, the software application can provide several additional functions besides basic functions such as data collection and transmission. One possible function is implementation of filtering algorithms on the smartphone 410 to mitigate issues due to motion and other artifacts, rendering cleaner data. In addition, the software application can provide a visualization interface on the smartphone 410 through which users can see salient features of their heart activity such as heart rate. An additional function is that the smartphone 410 software application can tag the data with the location of the wearer of the garment 200 . The location (e.g. latitude, longitude) collected is useful for both backend services as well as for the user himself/herself in case of a medical emergency.
In some embodiments, the software application on the smartphone 410 can run machine learning algorithms to perform preliminary anomaly detection. In case of an emergency, it can either alert the wearer and recommend him/her to hospital locations near his/her present location or make an automated call to the wearer's physician or emergency personnel with his/her present location. Thus caregivers can access into vital information anywhere and at any time within the healthcare networks for global level active monitoring. As an indication of the scalability of the system, a Zigbee-based WiFi system is capable of handling 65,000 patients at a given time.
In some embodiments the system 20 may include a Global Positioning System (GPS) module, for example as part of the control module 300 . Current location data from the GPS module included in the system 20 can be tagged (e.g. by the control module 300 or by the smartphone 410 software application) to the wearer's data and transferred to a remote (âcloudâ) data cluster and in addition can be stored in a secure database (e.g. an SD card can be installed in the control module 300 to save the data). For physician diagnostics a new backend service may be provided in which the doctor can log into a secured database and visually review the past and current sensor data from the garment 200 system 20 (as necessary). If the physician desires, he/she can employ machine learning algorithms (e.g. embedded in the control module 300 , the smartphone 410 software application, and/or the remote computing system 400 ) to detect abnormalities in the data. Further, a VoIP service can be used to make phone calls or send SMS messages to physicians from the wearer. Additionally, the smartphone 410 or other mobile device can send relevant abnormal data in advance to emergency services in the event the wearer receives medical assistance. The smartphone 410 or other mobile device, if equipped with a camera, can prompt the wearer to start a video call. Processes and steps for emergency or other situations are described in FIGS. 6 and 7 .
There are a number of uses of the system 20 disclosed herein, including wireless real-time monitoring of heart rate variability (HRV) and/or ECG and detection of asymptomatic myocardial ischemia in diabetic patients. Real-time monitoring using the system 20 also improves quality of life for patients with medical conditions that can elevate chances of asymptomatic (silent) ischemia attack.
Other uses of the system 20 include monitoring the health of the myocardium after administering ischemia-preventive drugs or reperfusion and disease management for patients with chronic coronary heart disease. The sensors, with wireless signal transmission, present a tool that provides real-time i
CLAIMS
Claims ( 20 )
What is claimed is:
1 . A system for cardiac monitoring of an individual, comprising:
a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes being arranged on the garment to record data for an ECG of the individual; a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data; and a wireless receiving station comprising a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter and to analyze the recorded data for the ECG, the second controller further configured to
analyze the recorded data,
identify an abnormality in the ECG, and
generate an alert if an abnormality in the ECG is identified.
2 . The system of claim 1 , wherein the abnormality in the ECG comprises an inverted T-wave.
3 . The system of claim 1 , wherein the plurality of nanostructured textile electrodes comprises a plurality of measured ECG leads.
4 . The system of claim 3 , wherein the plurality of measured ECG leads include leads I, II, V1, and V5-V6 of a 12-lead ECG.
5 . The system of claim 4 , wherein at least one lead of a 12-lead ECG is algebraically derived from at least one of the plurality of measured ECG leads.
6 . The system of claim 1 , wherein the first controller is electrically coupled to the plurality of nanostructured textile electrodes by fabric threads comprising silver.
7 . The system of claim 1 , wherein the plurality of nanostructured textile electrodes comprises dry electrodes.
8 . The system of claim 1 , wherein the first controller is connected to the individual.
9 . The system of claim 1 , wherein the wireless transmitter and the wireless receiver communicate using a ZigBee protocol.
10 . The system of claim 1 , wherein the alert is sent to one or more medical personnel.
11 . The system of claim 1 , wherein the plurality of nanostructured textile electrodes are integrated into fabric of the garment.
12 . The system of claim 1 , wherein the garment comprises a stretchable undergarment.
13 . A system for cardiac monitoring of a group of individuals, comprising
a plurality of wearable monitoring units, each wearable monitoring unit comprising
a garment having a plurality of nanostructured textile electrodes integrated therein, the electrodes being arranged on the garment to record data for an ECG of the individual;
a first controller electrically coupled to the plurality of electrodes, the controller including a wireless transmitter, the first controller being configured to collect the recorded data for the ECG from the plurality of electrodes and to cause the wireless transmitter to wirelessly transmit the recorded data; and
at least one wireless receiving station comprising a wireless receiver and a second controller, the second controller configured to cause the wireless receiver to receive the recorded data transmitted by the wireless transmitter and to analyze the recorded data for the ECG, the second controller further configured to
analyze the recorded data,
identify an abnormality in the ECG, and
generate an alert if an abnormality in the ECG is identified.
14 . The system of claim 13 , further comprising a second wireless receiving station, wherein each of the plurality of wearable monitoring units communicates with only one wireless receiving station.
15 . The system of claim 13 , wherein the abnormality in the ECG comprises an inverted T-wave.
16 . The system of claim 13 , wherein the plurality of nanostructured textile electrodes comprises a plurality of measured ECG leads.
17 . The system of claim 16 , wherein the plurality of measured ECG leads include leads I, II, V1, and V5-V6 of a 12-lead ECG.
18 . The system of claim 17 , wherein at least one lead of a 12-lead ECG is algebraically derived from at least one of the plurality of measured ECG leads.
19 . The system of claim 13 , wherein the first controller is electrically coupled to the plurality of nanostructured textile electrodes by fabric threads comprising silver.
20 . The system of claim 13 , wherein the plurality of nanostructured textile electrodes comprises dry electrodes.
US13/829,898
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Wearable remote electrophysiological monitoring system
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Smart materials, dry textile sensors, and electronics integration in clothing, bed sheets, and pillow cases for neurological, cardiac and/or pulmonary monitoring
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Wearable remote electrophysiological monitoring system
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Smart materials, dry textile sensors, and electronics integration in clothing, bed sheets, and pillow cases for neurological, cardiac and/or pulmonary monitoring
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Smart materials, dry textile sensors, and electronics integration in clothing, bed sheets, and pillow cases for neurological, cardiac and/or pulmonary monitoring
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