Adherent Device with Multiple Physiological Sensors
An adherent device to monitor a patient comprises an adhesive patch to adhere to a skin of the patient. At least four electrodes are connected to the patch and capable of electrically coupling to the patient. Impedance circuitry is coupled to the at least four electrodes to measure a hydration signal of the patient. Electrocardiogram circuitry is coupled to at least two of the at least four electrodes to measure an electrocardiogram signal of the patient. An accelerometer can be mechanically coupled to the adhesive patch to generate a signal in response to at least one of an activity or a position of the patient.
1 . An adherent device to monitor a patient, the device comprising:
an adhesive patch to adhere to a skin of the patient;
at least four electrodes connected to the patch and capable of electrically coupling to the patient;
impedance circuitry coupled to the at least four electrodes to measure a hydration signal of the patient;
electrocardiogram circuitry coupled to at least two of the at least four electrodes to measure an electrocardiogram signal of the patient; and
an accelerometer mechanically coupled to the adhesive patch to generate an accelerometer signal in response to at least one of an activity or a position of the patient.
2 . The adherent device of claim 1 wherein the adhesive patch is mechanically coupled to the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry and the accelerometer, such that the patch is capable of supporting the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry and the accelerometer when the adherent patch is adhered to the skin of the patient.
3 . The adherent device of claim 1 further comprising a wireless communication circuitry coupled to the impedance circuitry, the electrocardiogram circuitry and the accelerometer to transmit to a remote center with a communication protocol at least one of the hydration signal, the electrocardiogram signal or the accelerometer signal.
4 . The adherent device of claim 3 wherein wireless communication circuitry is configured to transmit the hydration signal, the electrocardiogram signal and the accelerometer signal to the remote center with a single wireless hop from the wireless communication circuitry to an intermediate device.
5 . The adherent device of claim 4 wherein the communication protocol comprises at least one of Bluetooth, Zigbee, WiFi, WiMax, IR, a cellular protocol, amplitude modulation or frequency modulation.
6 . The adherent device of claim 4 wherein the intermediate device comprises a data collection system to collect and/or store data from the wireless transmitter and wherein the data collection system is configured to communicate periodically with the remote center with wireless connection and/or wired communication.
7 . The adherent device of claim 4 wherein the communications protocol comprises a two way protocol such that the remote center is capable of issuing commands to control data collection.
8 . The adherent device of claim 1 wherein the accelerometer comprises at least one of a piezoelectric accelerometer, capacitive accelerometer or electromechanical accelerometer and wherein the accelerometer comprises a 3-axis accelerometer to measure at least one of an inclination, a position, an orientation or acceleration of the patient in three dimensions.
9 . The adherent device of claim 1 wherein the impedance circuitry is adapted to measure extra cellular fluid of the patient with at least one frequency within a range from about 0.5 kHz to about 200 kHz. and wherein the impedance circuitry is configured to determine a respiration of the patient.
10 . The adherent device of claim 1 wherein the device comprises a microphone to detect an audio signal from within the patient, the audio signal comprising a heart sound with an S 3 heart sound and/or a respiratory sound with rales and/or crackles.
11 . The adherent device of claim 1 wherein the device comprises a temperature sensor to measure a temperature of the patient.
12 . The adherent device of claim 1 wherein the device comprises a heat flux sensor to measure a skin heat flow of the patient.
13 . The adherent device of claim 1 comprising a processor comprising a tangible medium, the processor configured to control a collection and transmission of data from the impedance circuitry, the electrocardiogram circuitry and the accelerometer.
14 . The adherent device of claim 1 comprising a real time clock and a frequency generator.
15 . A method of monitoring a patient, the method comprising:
adhering an adhesive patch to a skin of the patient to couple at least four electrodes to the skin of the patient;
measuring a hydration signal of the patient with impedance circuitry coupled to the at least four electrodes;
measuring an electrocardiogram signal of the patient with electrocardiogram circuitry coupled to at least two of the at least four electrodes; and
measuring a signal from an accelerometer in response to at least one of an activity or a position of the patient.
16 . The method of claim 15 wherein the adhesive patch supports the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry and the accelerometer when the adherent patch is adhered to the skin of the patient.
17 . An adherent device to monitor a patient, the device comprising:
an adhesive patch to adhere to a skin of the patient;
at least four electrodes affixed to the patch and capable of electrically coupling to the patient, a maximum dimension across the at least 4 electrodes comprising no more that about eight inches, such that the at least four electrodes are capable of adhering to either a left side or a right side of the patient;
impedance circuitry coupled to the at least four electrodes to measure hydration of the patient; and
electrocardiogram circuitry coupled to at least two of the at least four electrodes to measure an electrocardiogram of the patient.
18 . The adherent device of claim 17 wherein the maximum distance across the at least four electrodes comprises no more than about six inches.
19 . The adherent device of claim 17 wherein the device comprises a maximum dimension across no more than about 8 inches and wherein the patch is capable of measuring the electrocardiogram and the impedance from a left side or a right side of the patient.
20 . An adherent device to monitor a patient for an extended period, the device comprising:
a breathable tape comprising a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient;
at least one electrode affixed to the breathable tape and capable of electrically coupling to a skin of the patient;
at least one gel disposed over a contact surface of the at least one electrode to electrically connect the electrode to the skin;
a circuit board connected to the breathable tape to support the printed circuit board with the breathable tape when the tape is adhered to the patient;
electronic components electrically connected to the printed circuit board and coupled to the at least one electrode to measure physiologic signals of the patient; and
a breathable water resistant cover disposed over the circuit board and electronic components and connected to at least one of the electronics components, the printed circuit board or the breathable tape.
21 . The adherent device of claim 20 further comprising an electronics housing adhered to at least one of the electronics components or the printed circuit board, such that the electronics housing is disposed between the cover and electronics components.
22 . The adherent device of claim 20 further comprising a gel cover positioned over the breathable tape to inhibit a flow of the gel through the breathable tape and wherein the printed circuit board is located over the gel cover such that the gel cover is disposed between the breathable tape and the printed circuit board.
23 . The adherent device of claim 20 wherein the breathable tape comprises a tricot-knit polyester fabric backing and the gel cover comprises a polyurethane, non-woven backing.
24 . The adherent device of claim 20 wherein the breathable tape comprises a first porosity and wherein the gel cover comprises a breathable tape with a second porosity, the second porosity less than the first porosity to inhibit flow of the gel through the breathable tape having the first porosity.
25 . The adherent device of claim 20 wherein breathable tape, the adhesive coating, the at least one electrode and gel are separable from the printed circuit board, electronic components and cover, such that the printed circuit board, electronic components, housing and cover are reusable.
26 . The adherent device of claim 20 wherein the at least one electrode extends through at least one aperture in the breathable tape.
27 . The adherent device of claim 20 wherein the at least one electrode is configured to electrically couple to the printed circuit board through the breathable tape.
28 . A method of monitoring a patient for an extended period, the method comprising:
attaching an electronics module to a first adherent patch component of a plurality of adherent patch components;
adhering the first adherent patch component to a skin of the patient;
removing the electronics module from the first adherent patch component; and
attaching the electronics module to a second patch component of the plurality of patch components after the first adherent patch component has been removed.
29 . The method of claim 28 further comprising:
removing the electronics module from the second adherent patch component; and
attaching the electronics module to a third patch component of the plurality of patch components after the second adherent patch component has been removed.
30 . The method of claim 29 further comprising measuring impedance signals when the third adherent patch component is adhered to the patient.
31 . A system to monitor a patient for an extended period, the system comprising:
a plurality of adherent patch components; and
an electronics module adapted to couple to each of the plurality of patch components for sequential measurements from each of the patch components.
32 . The system of claim 31 wherein each of the plurality of adherent patch components comprises a breathable tape with an adhesive coating to adhere the breathable tape to a skin of the patient, and at least one electrode affixed to the breathable tape.
33 . The system of claim 31 wherein the electronics module comprises a printed circuit board configured to connect electrically to the at least one electrode to measure physiologic signals of the patient, electronic components electrically connected to the printed circuit board, and a housing adhered to at least one of the electronics module or the printed circuit board.
34 . A method of monitoring a patient for an extended period of time, the method comprising:
placing a first adherent patch on a first side of the patient, the first adherent patch comprising first electrodes to measure at least one of an electrocardiogram or an impedance;
measuring the at least one of the electrocardiogram or the impedance from the first side of the patient for a first period of time;
removing the first patch from the first side of the patient;
placing a second adherent patch on a second side of the patient, the second patch comprising second electrodes to measure the at least one of the electrocardiogram or the impedance; and
measuring the at least one of the electrocardiogram or the impedance from the second side of the patient for a second period of time after the first patch has been removed.
35 . The method of claim 34 wherein the first side comprises at least one of a left side or a right side of the patient and the second side is opposite the first side.
36 . The method of claim 34 further comprising:
removing the second patch from the second side of the patient;
placing a third adherent patch on the first side of the patient, the third patch comprising third electrodes to measure the at least one of the electrocardiogram or the impedance; and
measuring the at least one of the electrocardiogram or the impedance from the first side of the patient for a third period of time after the second patch has been removed.
37 . The method of claim 36 further comprising:
removing the third patch from the first side of the patient;
placing a fourth adherent patch on the second side of the patient, the fourth patch comprising fourth electrodes to measure the at least one of the electrocardiogram or the impedance; and
measuring the at least one of the electrocardiogram or the impedance from the second side of the patient for a fourth period of time after the third patch has been removed.
38 . The method of claim 37 wherein each of the first period of time, the second period of time, the third period of time and the fourth period of time comprises at least about 1 week.
39 . A method of monitoring a patient for an extended period of time, the method comprising:
placing a first adherent patch on a skin location on a first side of the patient, the first adherent patch comprising first electrodes to measure at least one of an electrocardiogram or an impedance;
measuring the at least one of the electrocardiogram or the impedance from the first adherent patch on the first skin location for a first period of time;
removing the first patch from the first skin location;
placing a second adherent patch on a second skin location on a second side of the patient, the second patch comprising second electrodes to measure the at least one of the electrocardiogram or the impedance; and
measuring the at least one of the electrocardiogram or the impedance from the second skin location for a second period of time after the first patch has been removed.
40 . The method of claim 39 wherein the first skin location heals during the second period of time.
41 . An adherent device to monitor a patient, the device comprising:
an adhesive patch to adhere to a skin of the patient;
at least four electrodes mechanically coupled to the patch and capable of electrically coupling to the patient, the at least four electrodes comprising at least two force electrodes and at least two sense electrodes;
impedance circuitry electrically coupled to the at least two force electrodes to force an electrical current and coupled to the at least two sense electrodes to measure a hydration signal of the patient; and
electrocardiogram circuitry coupled to the at least two force electrodes to measure an electrocardiogram signal of the patient.
42 . The adherent device of claim 41 further comprising electrical switches connected to the at least two force electrodes to isolate the at least two force electrodes from the impedance circuitry when the electrocardiogram circuitry measures the electrocardiogram.
43 . The adherent device of claim 41 further comprising a processor configured to control the impedance circuitry and the electrocardiogram circuitry so as to time division multiplex collection the hydration signal and the electrocardiogram signal.
44 . The adherent device of claim 43 wherein the processor is configured to decouple the at least two force electrodes from the impedance circuitry when the electrocardiogram circuitry measures the electrocardiogram signal.
45 . The adherent device of claim 41 wherein the at least four electrodes comprise no more than four electrodes.
46 . The adherent device of claim 41 wherein the at least two force electrodes comprise outer electrodes and the at least two sense electrodes comprise inner electrodes.
47 . The adherent device of claim 41 wherein the at least two force electrodes comprise inner electrodes and the at least two sense electrodes comprise outer electrodes.
48 . A method of monitoring a patient, the method comprising:
adhering an adhesive patch to a skin of the patient so as to couple at least four electrodes to the skin of the patient, the at least four electrodes comprising at least two force electrodes and at least two sense electrodes;
measuring a hydration signal of the patient with impedance circuitry electrically coupled to the at least two force electrodes and to the at least two sense electrodes, such that the force electrodes force an electrical current between the at least two force electrodes; and
measuring an electrocardiogram signal of the patient with electrocardiogram circuitry coupled to the at least two force electrodes.
49 . The method of claim 48 wherein electrical switches connected to the at least two force electrodes are opened to isolate the at least two force electrodes from the impedance circuitry when the electrocardiogram circuitry measures the electrocardiogram.
50 . The method of claim 48 wherein the hydration signal and the electrocardiogram signal are time division multiplexed.
51 . An adherent device to monitor a patient, the device comprising:
an adhesive patch to adhere to a skin of the patient;
at least two electrodes connected to the patch and capable of electrically coupling to the patient;
circuitry coupled to the at least two electrodes and configured to measure at least two of an electrocardiogram signal of the patient, a respiration signal of the patient or an activity signal of the patient; and
a processor system comprising a tangible medium configured to trigger an alarm in response to the at least two of the electrocardiogram signal, the respiration signal or the activity signal.
52 . The adherent device of claim 51 wherein the processor system comprises a first processor comprising a tangible medium attached to the adherent patch and a second processor comprising a tangible medium at a remote center.
53 . The adherent device of claim 51 wherein the processor system comprises of a configuration for combining the at least two of the electrocardiogram signal, the respiration signal or the activity signal.
54 . The adherent device of claim 53 wherein combining comprises the processor system using the at least two of the electrocardiogram signal, the hydration signal, the respiration signal or the activity signal to look up a value in a previously existing array.
55 . The adherent device of claim 53 wherein combining comprises at least one of adding, subtracting, multiplying, scaling, or dividing the at least two of the electrocardiogram signal, the respiration signal, or the activity signal.
56 . The adherent device of claim 53 wherein the at least two of the electrocardiogram signal, the accelerometer signal, or the respiration signal are combined with at least one of a weighted combination, a tiered combination or a logic gated combination, a time weighted combination or a rate of change.
57 . The adherent device of claim 51 wherein the processor system is configured to continuously monitor, store and transmit to a remote center the at least two of the electrocardiogram signal, the respiration signal or the activity signal when the alarm is triggered.
58 . The adherent device of claim 51 wherein the processor system is configured to trigger the alarm and alert the patient and/or the physician in response to an adverse cardiac event.
59 . The adherent device of claim 51 wherein the processor system is configured to calculate and report a patient risk of sudden cardiac death to at least one of a remote center or a physician.
60 . The adherent device of claim 51 wherein the processor system is configured to detect at least one of a T-wave alternans, a pulsus alternans, an autonomic imbalance, a heart rate variability in response to the at least two of the electrocardiogram signal, the respiration signal or the activity signal.
61 . The adherent device of claim 51 wherein the processor system is configured to loop record the at least two of the electrocardiogram signal, the respiration signal or the activity signal for diagnosis of an unexplained syncope and/or arrhythmia when the alarm is triggered.
62 . The adherent device of claim 51 wherein the processor system is configured to detect an event comprising at least one of an atrial fibrillation in response to the electrocardiogram signal or an acute myocardial infarction in response to an ST segment elevation of the electrocardiogram signal.
63 . The adherent device of claim 51 wherein the processor system is configured to monitor a high risk patent post myocardial infarction with the at least two of the electrocardiogram signal, the respiration signal or the activity signal.
64 . The adherent device of claim 51 wherein the processor system is configured to continuously monitor a bradycardia of the patient at risk for sudden death, the electrocardiogram signal comprising at least one of a Brugada Syndrome with an ST elevation and a short QT interval or long-QT interval.
65 . The adherent device of claim 51 wherein the processor system is configured to monitor the electrocardiogram signal and alert at least one of a patient, a remote center, a physician, emergency responder, or family/caregiver in response to an adverse event.
66 . The adherent device of claim 51 wherein the processor system is configured to determine a tiered response to the at least two of the electrocardiogram signal, the respiration signal or the activity signal.
67 . The adherent device of claim 66 wherein the tiered response comprises a first tier to contact an emergency responder in response to an immediate life threatening event, a second tier to contact a physician in response to an event that requires medical care, a third tier to contact a family member and/or care giver, and a fourth tier to contact the center.
68 . The adherent device of claim 66 wherein immediate life threatening event comprises at least one of a sustained ventricular tachycardia, a sustained ventricular fibrillation, an asystole, an arrhythmia with no respiration or an arrhythmia with no patient movement.
69 . The adherent device of claim 66 wherein the event that requires medical care comprises an atrial fibrillation that is not immediately life threatening.
70 . The adherent device of claim 67 wherein wireless communication circuitry is configured to transmit the at least two of the electrocardiogram signal, the respiration signal or the activity signal with a single wireless hop from the wireless communication circuitry to an intermediate device.
71 . A method of monitoring a patient, the method comprising:
adhering an adhesive patch to a skin of the patient so as to couple at least two electrodes to the skin of the patient;
measuring at least two of an electrocardiogram signal of the patient, a respiration signal of the patient or an activity signal of the patient with circuitry coupled to the at least two electrodes; and
triggering an alarm in response to the at least two of the electrocardiogram signal, the respiration signal or the activity signal with a processor system comprising a tangible medium.
72 . The method of claim 71 wherein the processor system comprises a first processor comprising a tangible medium attached to the adherent patch and a second processor comprising a tangible medium at a remote center.
73 . The method of claim 71 comprising combining at least two of the electrocardiogram signal, the respiration signal, or the activity signal.
74 . The method of claim 73 wherein combining comprises the processor system using the at least two of the electrocardiogram signal, the hydration signal, the respiration signal or the activity signal to look up a value in a previously existing array.
75 . The method of claim 73 wherein combining comprises at least one of adding, subtracting, multiplying, scaling, or dividing the at least two of the electrocardiogram signal, the respiration signal, or the activity signal.
76 . The method of claim 73 wherein the at least two of the electrocardiogram signal, the accelerometer signal, or the respiration signal are combined with at least one of a weighted combination, a tiered combination or a logic gated combination, a time weighted combination or a rate of change.
77 . The method of claim 71 wherein the at least two of the electrocardiogram signal, the respiration signal, or the activity signal are continuously monitored, stored, and/or transmitted to a remote center.
78 . The method of claim 71 wherein the alarm is triggered and the patient and/or the physician is alerted in response to an adverse cardiac event.
79 . The method of claim 71 wherein a patient risk of sudden cardiac death is calculated and/or reported to at least one of a remote center or a physician.
80 . The method of claim 71 wherein at least one of a T-wave alternans, a pulsus alternans, an autonomic imbalance, a heart rate variability in response to the at least two of the electrocardiogram signal, the respiration signal or the activity signal is detected.
81 . The method of claim 71 wherein the at least two of the electrocardiogram signal, the respiration signal or the activity signal is loop recorded when the alarm is triggered.
82 . The method of claim 71 wherein an event comprising at least one of an atrial fibrillation in response to the electrocardiogram signal or an acute myocardial infarction in response to an ST segment elevation of the electrocardiogram signal is detected.
83 . The method of claim 71 wherein a high risk patent post myocardial infarction is monitored with the at least two of the electrocardiogram signal, the respiration signal or the activity signal.
84 . The method of claim 71 wherein a bradycardia of the patient at risk for sudden death, the electrocardiogram signal comprising at least one of a Brugada Syndrome with an ST elevation and a short QT interval or long-QT interval are continuously monitored.
85 . The method of claim 71 wherein the electrocardiogram signal is monitored and/or at least one of a patient, a remote center, a physician, emergency responder, or family/caregiver is alerted in response to an adverse event.
86 . The method of claim 71 wherein a tiered response to the at least two of the electrocardiogram signal, the respiration signal or the activity signal is determined.
87 . The method of claim 86 wherein the tiered response comprises a first tier to contact an emergency responder in response to an immediate life threatening event, a second tier to contact a physician in response to an event that requires medical care, a third tier to contact a family member and/or care giver, and a fourth tier to contact the center.
88 . The method of claim 86 wherein immediate life threatening event comprises at least one of a sustained ventricular tachycardia, a sustained ventricular fibrillation, an asystole, an arrhythmia with no respiration or an arrhythmia with no patient movement.
89 . The method of claim 86 wherein the event that requires medical care comprises an atrial fibrillation that is not immediately life threatening.
90 . The method of claim 87 wherein wireless communication circuitry transmits the at least two of the electrocardiogram signal, the respiration signal or the activity signal with a single wireless hop from the wireless communication circuitry to an intermediate device.