Software Technology for “Therapeutic device with acoustic sensor”

Electronics – Thomas E. Kaib, Zoll Medical Corp

Abstract for “Therapeutic device with acoustic sensor”

A therapeutic device includes a substrate, a conductive layer on the substrate, and an electrically conducting gel reservoir that releases an electricallyconductive gel onto the surface of the conductive layers. The therapy electrode is coupled with an acoustic sensor. The acoustic sensors are designed to acoustically attach to the body of a subject to whom the therapy electrode is applied, and detect sounds that indicate a subject’s health. The therapeutic device can transmit data about the sounds that are detected by the acoustic sensors to an external system for processing or analysis.

Background for “Therapeutic device with acoustic sensor”

“1. “1.

“Aspects, embodiments, and the present disclosure are directed at medical therapy systems and, more specifically, electrode systems including one or multiple acoustic sensor and systems for analyzing the heart sounds detected by one or more of the acoustic sensor.”

“2. “2.

“Cardiac arrhythmia and other cardiac ailments are a leading cause of death. In an effort to save the victim’s life, there are many resuscitation strategies that aim to keep the body’s circulation and respiratory system functioning during cardiac arrest. The victim’s survival chances are better if these efforts are initiated quickly. These efforts are costly and have a low success rate. Heart attacks, among others, continue to take the lives of victims.

“According to an aspect of the current disclosure, there is a therapeutic device that includes a layer to deliver therapy to a subject and an attached acoustic sensor. An acoustic sensor could be a multi-channel, three-axis MEMS accelerometer. The acoustic sensor may include associated electronics to indicate whether the therapeutic device was correctly oriented on a subject. An accelerometer with three channels may be part of the acoustic sensor.

“Some embodiments of the therapeutic device include a therapy electrode that contains a conductive layer to deliver therapy to the subject. The therapy electrode can be used to either apply a selective defibrillation shock or to electrically pace the heart. The therapy electrode can be used to monitor the ECG of the subject. The therapy may also include a defibrillation pulse. The therapy electrode may also include an electrically conductive gel reservoir that releases an electricallyconductive gel onto the surface of the conductive layers. The acoustic sensors may be mechanically connected to the layer or electrically coupled. Through a cap that houses the conductive gel reservoir, the acoustic sensor can be acoustically connected to the surface. An internal surface of the cap may be used to attach the acoustic sensor. The cap may have an upper wall that houses the acoustic sensor. An acoustic sensor can be attached to the cap’s upper wall. This will allow it to record sounds indicative of heartbeats. A connector or signal conductor may be used to electrically connect the acoustic sensor and a circuit board to the therapeutic devices. The connector or signal conductor is coupled to the therapeutic devices with enough slack for the therapy electrodes to flex. The extending connector may also be used to provide the slack along a multi-dimensional path.

“Some embodiments include an adhesive layer that is used to attach the device to the subject.”

“In some embodiments, a controller is added to the therapeutic device to prompt the subject’s verbal response before delivering a therapy. In some embodiments, a defibrillation pulse may be used. The controller can also be configured to halt the delivery of therapy when the subject’s voice is detected by the acoustic sensors. The controller can be programmed to distinguish between the subject’s voice and the voice of another person detected by the acoustic sensors. The controller can be programmed to respond to the detection of voice of subject by the microphone and the detection of voice of another person by the acoustic detector.

“According to another aspect of this disclosure, an electrode assembly is provided that comprises a substrate and an electrically conducting layer. The electrode portion of an electrode assembly is formed by the electrically conductive layer. The first surface of the electrically conductive layer can be placed next to a patient’s skin. An impedance reduction system is also included in the electrode assembly. This system is designed to apply an electricallyconductive gel to the first surface of the layer. In response to an activation signal, an acoustic sensor is attached to the electrode portion of electrode assembly. An ECG sensing electrode may be included in the electrode assembly to monitor the patient’s ECG.

The acoustic sensor could include a multi-channel, three-axis MEMS accelerometer. A three-channel accelerometer may be included in the acoustic sensor. One embodiment uses a three-channel accelerometer to monitor the sounds of the heart. A second channel is used to monitor the patient’s respiration. The third channel is used to monitor the patient’s movement.

“In some embodiments, an acoustic sensor can be electrically connected to a system that records signals indicative of sounds generated by the heart of the patient. The system can also be configured to analyze signals indicative of sounds produced by the patient’s heart. The system could also be configured to alert the patient if the heart sounds are indicative of an abnormal cardiac condition.

“In some embodiments, an impedance reduction device includes a conductive jelly reservoir that can be used to store a portion of the electrically-conductive gel that will be applied to the first surface of the electrically conducting layer in response to activation signals. Through a cap that covers the conductive gel reservoir, the acoustic sensor can be acoustically connected to the electrically-conductive layer. The cap may have an internal wall that connects the acoustic sensor to it mechanically. The cap may have an upper inner wall that houses the acoustic sensor.

“According to another aspect of this disclosure, there is a method for monitoring physiological parameters in a subject.” This method involves monitoring the heart sounds of the subjects using an acoustic device physically coupled to a therapeutic electrode or defibrillation electrode. The acoustic sensors also monitor at least one additional parameter related to the state of the subjects using the acoustic sensors, which may include one or more parameters associated with respiration, gastrointestinal sounds, and body movements.

“In some embodiments, at least one additional parameter may include the body position of the subject. One parameter that is associated with the subject’s respiration may include sounds and movements of the chest. Monitoring at least one parameter that is related to a subject’s state may include monitoring two or more parameters.

“In accordance to another aspect of this disclosure, there is a method for monitoring physiological parameters in a subject. This method involves providing a therapeutic device, such as a therapy or defibrillation electrode, with at least one audio sensor that is acoustically coupled. The at least 1 acoustic sensors are configured to monitor the heart sounds and at least one additional physiological parameters of the subjects. These include one or more of the following: gastrointestinal sounds, respiration, body movements, and snoring.

“The present invention’s aspects and embodiments are not limited to the construction details and arrangement of the components described in the following description, or illustrated in the drawings. This invention can be practiced in many different ways and has other embodiments. The terminology and phraseology used in this document are for descriptive purposes only and should not be considered as restrictive. The use of the word?including? ?comprising,? ?having,? ?containing,? ?involving,? ?involving,?

“The wearable medical devices 100 include a number of therapy electrodes (114a,114b) that are electrically connected to the control unit 120 via connection pod 130. They are capable of delivering one to three therapeutic defibrillating shocked to the subject if necessary. Other embodiments of the therapy electrodes can provide additional forms of therapy such as electrical pacing to the subject’s heart or stimulating nerves with electric current as part of Transcutaneous Electrical Nerve Stimulation therapy (TENS). The plurality of therapy electrodes comprises a first therapy electrode (114a) that is placed on the subject’s front and a second therapy device (114b) that is located on the subject’s back. The second therapy electrode (114 b) includes a pair therapy electrodes that are electrically connected together and serve as the second therapy 114.b. Two therapy electrodes 114a,114b allow a biphasic to be delivered to the subject’s body. One therapy electrode may deliver a phase of the biphasic shocked with one therapy electrode acting to return. The other therapy electrode may deliver the second stage of the biphasichock with the return therapy electrode. The belt 110 may be positioned higher than the FIG. 1. so that the plurality ECG sensing electrodes 112 as well as the plurality therapy electrodes (114 a,114 b) are generally placed in a plane intersecting with the subject’s heart. One or more ECG sensing electrodes 112 or therapy electrodes 114a,114b may be equipped with an adhesive layer to help hold the electrodes in the correct position.

The connection pod 130 connects the plurality ECG sensing electrodes 112 and the plurality therapy electrodes (114 a,114 b) to the control 120. It may also include electronic circuitry. One example is the connection pod 130, which includes signal acquisition circuitry. This may include a plurality differential amplifiers that receive ECG signals from different ECG sensing electrodes 112 in order to generate a differential ECG signal for the control unit 120 based upon the difference. Other electronic circuitry may also be included in the connection pod 130, such as an accelerometer or motion sensor that can monitor subject activity.

“In some embodiments the therapy electrodes (114a,114b) may be multi-purpose electrodes. The therapy electrodes 120 a, 114b can deliver a shock to the subject, and may also provide electrical pacing or TENS therapy.

“As shown at FIG. “As shown in FIG. 1, the wearable medical devices 100 include a user interface pod 140, which is electrically connected to the control unit 120. A clip (not shown), that attaches to a section of the interface pod 140, can be used to attach the user interface pod 140 to the subject’s clothing. The user interface pod 140 can also be carried in the hand of a person. The user interface pod 140 can communicate wirelessly with control unit 120 in some embodiments. This could be done using Bluetooth?, Wireless USB? ZigBee or Wireless Ethernet? GSM or another type of communication interface. The user interface pod 140 usually includes a number of buttons that the subject, or bystander, can use to communicate with control unit 120. A speaker is also used by control unit 120 to communicate with the subject and the bystander. If the control 120 detects that the subject has cardiac arrhythmia and issues an audible alarm (not shown), the control 120 can issue an alert to the subject and anyone else who may be watching. To indicate consciousness, the control 120 may instruct the subject to press the buttons on the control 120 or the user interface pod 140 and hold them. This will instruct the control 120 to stop the delivery of therapeutic defibrillating shockeds. The device can assume that the subject is not responding and continue with the treatment, which may include the delivery of one or several defibrillating shots to the subject’s body. The functionality of the user interface pod 140 can be integrated into control unit 120 in some embodiments.

It has been found that analysis of sounds 101 produced by a subject’s cardiac muscle due to electro-mechanical activity can provide valuable information about the health of their heart. This data can be combined with or substituted for ECG data to provide information such as a warning sign of potential cardiac problems or a possible impending event, such as cardiac arrest. To determine if a subject’s cardiac condition has improved or worsened, the analysis of his heart sounds may be performed over longer time periods, such as days, weeks or months. U.S. Pat. describes some of the systems and methods that can be used to analyze the sounds of a subject’s hearts and the information this analysis might provide. Nos. Nos. 7,302,290 and 7,668,589 are included herein as references in their entirety.

“In some embodiments, the wearable medical device 100 may also include or replace ECG sensing electrodes 112. 3A) to detect the sounds made by the subject’s hearts. One or more parts of the wearable medical devices 100 may have an acoustic sensor or an audio transducer 260. The acoustic sensor or audio transducer 260 can be placed within the harness 110, or connected to one of the ECG electrodes 112 or therapy electrodes (114 a,114 b). The acoustic sensor or audio transducer 260 can be placed on or within electrodes that are located on the front, back, or sides of a subject. The electrodes that attach to the harness 110 may hold the electrodes against the skin of a subject who is wearing the wearable device 100. 4). 4).

“In some embodiments, it may be desirable for the acoustic sensors(s), or audio transducer (s) 260 to be located proximate or in contact with the subject’s skin so that heart sounds can be detected more easily than if they were further away from the subject. The acoustic sensors or audio transducer 260 may be acoustically connected to the subject’s heart, even though they are not physically in contact with his skin. It may be desirable for the audio transducer (or acoustic sensor) to be located near or in contact with the subject’s skin. This is to ensure that the sounds of the heart are not diminished by travel through the body. An electrode portion of the therapy electrode assembly 100 in a wearable device 100 may be placed above the subject’s heart and in contact with their skin. In some embodiments, an acoustic sensor (or audio transducer) 260 may be placed on or within the electrode portion of a therapy electro assembly that is located close to the subject’s chest, such as proximate his left ventricle.

“The control unit 120 could include a memory unit that records data about the heart sounds. Some embodiments may store recorded heart sounds data on removable memory cards, such as an SD card. The control unit’s processor may use the recorded heart sounds to detect potential heart problems. The data concerning the heart sounds can be sent to an external system for analysis and processing. This can be done wirelessly or via a wired connection to an outside system.

“Feedback102” may be given to the subject via a speaker or display on the control unit 120, if the analysis 101 of the subject?s heart sounds provides an indication of a problem or a possibility of an impending cardiac event (e.g., cardiac arrest). You can also access the results of the analysis by the subject’s heart sounds through an external device. For example, you may be able to view the results through a website or display of an external system.

Two normal heart sounds are present in healthy adults. They are commonly called S1 and 2. S3 is a third sound that can be heard in the heart and may indicate a problem. S3 can be associated with abnormal diastolic filling patterns in older subjects (e.g., those over 40). S3 could indicate cardiac problems such as a failing left ventricle or dilated congestive hearts failure. S4 is a fourth sound in the heart, also known as a presystolic or atrial gallop. It can indicate a problem with the heart. S4 can be associated with stiffness in the left ventricular. Some subjects may experience heart murmurs, which could indicate cardiac problems.

The acoustic sensor(s), or audio transducer(s), 260, and the associated recording and analysis systems can be configured to detect and record any or all of S1, S2, S3, or S4. The heart sound recording and monitoring systems can also record other parameters such as electromechanical activation (EMAT), percentage (% EMAT), and left-ventricular systolic (LVST) heart sounds. EMAT is measured between the onset and closure of the mitral valle within the S1 sound. Extended EMAT has been linked to a lower left ventricular ejection percentage (LVEF), which is a measure of how blood is being pumped from the left ventricle of your heart with each contraction. % EMAT equals EMAT divided by dominant RR interval. The efficiency of the pump function of your heart is reflected in % EMAT. SDI is a multiplicative mixture of ECG sound parameters (EMA and S3). SDI is a highly specific method of predicting left ventricular dysfunction. The time interval between the heart sounds S1 and S2 is called LVST. It is the systolic part of the cardiac cycle. LVST is subject to some heart rate dependence and can be as high as 40% (30-50%) of the cardiac cycle. However, it can also be affected by diseases that cause poor contractility or a low ejection percentage.

“Data concerning any one or more of these heart sound parameters can be recorded and displayed in trend charts. This data may be accessed by the subject or care provider via the control unit 120, or another device. You may also set control limits for any of these parameters. The control unit 120, or an external system to whom the heart sound data are transmitted, may compare the measured (or calculated) parameters to determine the control limits. If any of these limits is violated, a warning can be given to the subject via a speaker, display of the control 120, or user interface pod 140.

“In certain embodiments, the audio transducer(s), 260 or acoustic sensor(s), 260 may be set up to recognize the voice of the subject wearing the wearable medical devices. A patient voice signature may then be used as a response mechanism. The control unit 120’s processor may be trained to recognize the voice and use speech recognition and voice analysis techniques. The control unit 120 can then prompt the subject to say a predetermined phrase or word, such as through a speaker or display. If the control 120 detects that the subject has cardiac arrhythmia the control 120 may emit an audible alarm through a speaker (not illustrated) on the control 120 or the user interface pod 140, alerting the subject as well as any other bystanders about the subject’s condition. The control unit 120 can also instruct the subject that they speak a word, phrase, or combination thereof. This information is transmitted to the control 120 by the audio transducer(s), 260, and is used to notify the control 120 that the subject is awake. The device can assume that the subject is not responding and continue with the treatment sequence. This may include the delivery of one or several defibrillating shots to the body.

The control unit 120 can be set up to distinguish between the voice and voice of the subject. This could include a professional EMT, first responder, bystander or passerby. The control unit 120 can analyze the voice of a person who speaks in response to a prompt to determine if it is the voice of the subject. The control unit 120 may ask the subject to repeat the instructions, repeating them if it is the voice from another person. To make sure that the subject follows the instructions, the control unit can modify the instructions to ask for silence from others around it. The control unit 120 can monitor the audio transducer(s), 260 or acoustic sensor(s), 260 for signals from other people proximate to the subject. The control unit 120 can detect the voice of another person and issue instructions to the subject. This may be done through a speaker, or through a display. The control unit 120 can alter the course of treatment. For example, it may postpone or abort delivery of one or more defibrillating shots to the body of the subject. It may also provide data about the subject’s condition. If, for instance, the control unit 120 detects the voice of a person, the bystander responds by pressing the control unit 120 to indicate that professional assistance has arrived to help the subject. The control unit 120 may change to an alternate mode of operation if professional assistance is detected. In this case, the ambulatory treatment device 100 and the monitoring device 100 will support the medical assistance.

As mentioned above, wearable medical devices, such as a defibrillator or wearable ECG sensing electrode, are worn almost continuously by subjects to protect against cardiac arrest. The wearable medical device is often worn almost continuously so dry electrodes can be used for the plurality ECG sensing electrodes 112. and the plurality therapy electrodes (114 a,114 b) for comfort and skin irritation. The control unit 120 sends a signal (114 a,114 b) to the plurality therapy electrodes to release an impedance-reducing gel before delivering one or more shocks to the body. The impedance-reducing gel lowers the resistance between the electrodes’ conductive surfaces and the skin of the subject, improving the energy delivery and decreasing the risk of skin irritation (e.g., burning, reddening or other forms of irritation).

“FIG. 2A is a plan of the electrode portion of a therapy electrode array that includes an impedance-reduction system. It can be used with a wearable device such as the wearable cardiac defibrillator discussed above in relation to FIG. 1. FIG. FIG. 2B shows a functional block diagram for the impedance reduction device that is part of the electrode portion of therapy electrode assembly. 2A. 2A. The electrode portion 200 is made up of a multi-layered laminated structure. It includes an electrically conductive layer (not visible in FIG. 2A, but located on the bottom of the embodiment electrode portion 250 shown at FIG. 2D), which forms the electrode and an impedance-reduction system 201. The electrically conductive layer should be placed adjacent to the subject’s skin. However, portions of harness 110 (FIG. 1. and/or portions may be placed between the electrically-conductive layer and subject’s skin. FIG. FIG. 2A shows that the impedance reduction device 201 is located on the electrode portion 200 (i.e. the top-side in FIG. 2A) is on the opposite side of the conductive layer.

“The impedance reducing system 201 contains a plurality conductive gel reservoirs210 that have a respective gel delivery outlets 220. They are fluidly coupled with a fluid channel (230) and a fluid source (240). The fluid pressure source (240) is fluidly coupled with the fluid channel 233. An activation signal activates the channel 230 and forces a fluid such as nitrogen gas into it. Hydraulic pressure from the activated fluid source 240 in fluid channel 230 forces the conductive jelly stored in each of these gel reservoirs out through the plurality o gel delivery outlets 220. Through apertures in the electrically conductive layer, the liquid is forced onto the exposed surface. This layer, which is in use, is located most closely to the subject’s head. The plurality of gel outlet 220 are aligned with the apertures in the electrically-conductive layer so that the electrically active gel is dispersed onto the electrode portion closest to the subject’s body when activated. U.S. Pat. 200 provides more information about the construction of electrode portion 200. No. 5,078,134 (hereinafter ?the ‘134 patent?) which is incorporated by reference herein

“FIG. 2C shows an electrode portion 250 of an assembly that includes an acoustic sense 260. FIG. FIG. 2C. 2C. FIG. 2C illustrates the acoustic sensor 265. 2C as it is inserted within a cap 215. Enclosing one conductive gel reservoir 210 of electrode portion 250 What is the cap 215? The cap 215 is made of a sound conducting material such as a hard plastic. What is the cap 215? FIG. 2C shows the cap as transparent. 2C to show the position of the Acoustic Sensor 260. The acoustic sensors 260 and 215 are mechanically and acoustically connected to the upper interior wall of the cap. An adhesive, such as epoxy or another type of glue, or one or more mechanical fasteners (e.g. snaps, tabs or any other fasteners) can be used to attach the acoustic sensor 260 to the cap 215? The shell 215 contains the conductive gel reservoir 215. The acoustic sensor 265. The acoustic sensors 260 are positioned and configured to be acoustically connected to the subject to whom the electrode portion 250 has been applied. The shell 215 may be used to acoustically couple the acoustic sensors 260 to the bodies of subjects to whom the electrode portion 250 has been applied. The substrate 280. You can facilitate acoustic coupling by minimizing or eliminating any gaps between the shell 215 and 260. and the shell 215? The electrode portion 250’s substrate 280. To cover the electrode portion’s upper surface 250, a protective cover 290 may be used. It may be made from foam rubber.

“The cap 215. Housing the acoustic sensors 260 can be formed differently from caps 215 that enclose the conductive gel reservoirs210 of the electrode portion 250. The cap 215 could be an example. An upper wall that includes the acoustic sensors may be flattened in order to allow for the attachment of the 260. Caps 215 that do not contain acoustic sensors might have substantially rounded upper wall.

“A connector, or signal conductor, 270 provides an electrical connection between the acoustic sensors 260 and the circuit board 275. It is connected to the electrode portion 250. Some embodiments of the signal conductor are coupled to the electrode portion 250 by an adhesive, one or more mechanical fasteners, or both. FIG. 2C shows that the signal conductor may have some slack. This could be done by routing it along a multi-dimensional path so that the electrode portion 250 can be flexed without being detached from the circuit board 275 or acoustic sensor 265. For electrode portions 250 that have been specifically designed to allow for greater flexibility, such as one or more of those disclosed in co-owned U.S. Pat. No. No. 8.880,196, titled FLEXIBLE THEAPY ELECTRODE. This is incorporated herein in its entirety.

“In other embodiments the acoustic sensors 260 could be found on or near the electrode portion 250. FIG. 3B shows that the acoustic sensors 260 can be placed on a portion 280 of the electrode portion 250. Alternate embodiments of the acoustic sensors 260 can be placed anywhere it can acoustically couple with a subject’s body. The electrode portion 250 can include one acoustic sensor, as shown, or multiple acoustic sensing devices 260.

“The acoustic sensors 260 can include any device that detects sounds from the heart of a subject and provides an output signal responsive. The acoustic sensors 260 may include a microphone. The acoustic sensor 262 may include an accelerometer. The acoustic sensor 260 may comprise a microelectromechanical system (MEMS) accelerometer. The acoustic sensor 262 may include a multi-channel accelerometer. An acoustic sensor could include a three-channel accelerometer that senses movement in each of the three orthogonal directions. A LIS344ALH accelerometer from STMicroelectronics, is an example of an accelerometer that may be used in certain embodiments. The acoustic sensor 262 and its associated electronics can be used to monitor a subject?s respiration, heart sounds, position, activity, and other parameters. Other sounds that could indicate a subject’s health, such as snoring, stomach sounds, or gastrointestinal sounds, may also be monitored by the acoustic sensors 260 and their associated electronics. The acoustic sensors 260 can provide signals indicative that the subject’s respiration is being monitored on one channel and signals indicative that the subject’s heart sounds are being monitored on another channel. Signals indicative of the subject?s position on a third channel may also be provided. Other embodiments may use the various channels to indicate signals indicative of multiple physiological parameters or other parameters related to the subject’s state. In one embodiment, the acoustic sensors 260 might provide signals that indicate the subject?s heart beat on a first channel and signals that indicate the subject?s respiration on another channel. Signals indicative of the subject?s body position on any of the channels, first, second, or third, may also be provided by the sensor. Multiple signals related to the parameter being monitored can be received on a single channel, or over multiple channels depending on the parameter. In some cases, the associated electronics and acoustic sensor 262 can also detect sounds that indicate the release or inactivation of conductive liquid from the electrode portion 250 of a therapy electrode assembly.

Further, an accelerometer may be used to enable the acoustic sensors 260 and associated electronics to indicate whether an electrode assembly with the acoustic sensing has been properly placed on a subject. The acoustic sensors 260 and associated electronics can be used to detect, for instance, the direction of Earth’s gravity and the orientation of acoustic sensors 260. This may also indicate the location of the therapy electrode assemblies. The acoustic sensors 260 and associated electronics can be used to determine if the therapy electrode assembly was correctly placed on a subject, or if it has been placed incorrectly, such as in an inverted position.

The acoustic sensor 2260 and the electronics that are associated with it may be used to detect if CPR is being administered to the subject. If so, the signal will be sent to indicate the result. Electronics associated with the acoustic sensors 260 can be used to analyze motion related to CPR. For example, they may measure the depth and rate of chest compressions. An acoustic sensor may be attached to a portion or a position on a therapy electrode assembly. This could be, for example, on a tab that extends from electrode portion 250 or on a position on a wearable medical instrument 100. The position would be close to the xiphoid (116) of the subject when the device is worn by the subject. 1. This would enable the placement of an acoustic sensors to measure the depth of chest compressions while administering CPR. It could also detect if CPR is being administered. The electronic components of the acoustic sensor 262 may provide feedback to the person performing CPR. This could be done through one or more indicators, or through a speaker. This will allow for more efficient administration.

“Applicants recognize that redundancy may be desirable in some instances of the impedance-reduction system described above. Co-owned U.S. Pat. reveals electrodes that include redundant impedance reduction system. No. No. 8,406,842, which is incorporated herein in its entirety.”

“FIG. 3A shows an electrode assembly which combines one or several ECG sensing electrodes with a therapy electrode and redundant impedance reducer systems into a single integrated assembly according to a further aspect. The electrode assembly 400 has two pairs of ECG sensing electrodes 412a, 412b to monitor the cardiac function of the subject. Further, the electrode assembly 400 includes a therapy electrode 414 and at least two impedance-reduction systems 301, 302. An insulator may be used to electrically separate the pair of ECG sensing electrodes 412a, 412b from the therapy electrode 414. In other embodiments of the electrode assembly 400, only one ECG sensing electro may be used, while other embodiments may contain more than two ECG sensing devices. These alternative embodiments may have different placements and numbers of ECG sensing sensors than the FIG. 3A. Another embodiment of the integrated electrode assembly may contain additional sensors 416. These sensors, in addition to the ECG sensing electrodes, therapy electrode and one or more ECG electrodes, are capable of monitoring physiological parameters such as blood pressure, heart rate (or pulse oxygen level), heart rate, respiration rate, heart sounds, heart beat, heart rate, etc. One or more acoustic sensor 260 may be included in the additional sensors 416.

The electrode assembly 400 can be worn on the body of the subject such that one of two ECG sensing electrodes 412a, 412b is placed in the middle of the subject’s chest, while the other electrode 412a, 412b is on the side. FIG. 4. The electrode assembly 400 can be worn on the front side of the subject’s body, with the ECG sensing electro 412a positioned in the middle of the chest and the other 412b on the left. Another electrode assembly 400 is also available. A second electrode assembly 400 may be worn on the backside of the subject’s body to provide a second pair ECG sensing electros 412a?, 412b?. 400? is located in the middle of the subject’s back. The other ECG sensing electro (for example, ECG sensor electrode 412b?) is placed at the same location. The second pair of ECG sensing electrodes 400? is placed on the subject’s right side opposite the other ECG sensor electrode (e.g., ECG sensing electro 412b) of the first ECG sensing pairs 412a, 412b, as shown in FIG. 4. This arrangement allows for a front-to back pairing of ECG sensing electros (for instance, 412a, 412a? You can also have a side-to -side pairing of ECG sensing electros (for instance, 412a, 412a?). You should know that there are other options for the first and second electrode assemblies 400 and 400. Alternate placements may be possible. The first electrode assembly 400 could be placed on the one side of the subject’s body, while the second electrode assembly 400 is placed on the other. To provide side-to side pairings of ECG sensing electros, the second electrode assembly 400 may be placed on the opposite side of the subject.

“The first and the second electrode assemblies 400, 400?” The electrodes assemblies 400, 400 may have an electrically conductive adhesive coating. They can be attached directly to the skin of the subject, or attached to the harness, as shown in FIG. 1. and held against the subject’s torso. If only one electrode assembly contains an acoustic sensors 260, the electrode assembly can be placed so that it is located proximate to the subject’s heart.

“In further embodiments acoustic sensors 265 for monitoring any parameter described herein, such as sounds associated with a subjects heart, respiration, orientation, or movement associated with administering CPR to a patient, can be included in electrodes with shapes and materials of different construction from those shown in FIGS. 2C and 2D. 2C and 2D. The functionality of acoustic sensors 260 in electrodes is not limited to one particular type or form.

“Having described at least one aspect of the invention, it is to been appreciated that many alterations, modifications, or improvements can be made by those who are skilled in this art. These modifications, alterations, and improvements are included in this disclosure and are considered part of the scope of the invention. The above description and drawings should be considered an example.

Summary for “Therapeutic device with acoustic sensor”

“1. “1.

“Aspects, embodiments, and the present disclosure are directed at medical therapy systems and, more specifically, electrode systems including one or multiple acoustic sensor and systems for analyzing the heart sounds detected by one or more of the acoustic sensor.”

“2. “2.

“Cardiac arrhythmia and other cardiac ailments are a leading cause of death. In an effort to save the victim’s life, there are many resuscitation strategies that aim to keep the body’s circulation and respiratory system functioning during cardiac arrest. The victim’s survival chances are better if these efforts are initiated quickly. These efforts are costly and have a low success rate. Heart attacks, among others, continue to take the lives of victims.

“According to an aspect of the current disclosure, there is a therapeutic device that includes a layer to deliver therapy to a subject and an attached acoustic sensor. An acoustic sensor could be a multi-channel, three-axis MEMS accelerometer. The acoustic sensor may include associated electronics to indicate whether the therapeutic device was correctly oriented on a subject. An accelerometer with three channels may be part of the acoustic sensor.

“Some embodiments of the therapeutic device include a therapy electrode that contains a conductive layer to deliver therapy to the subject. The therapy electrode can be used to either apply a selective defibrillation shock or to electrically pace the heart. The therapy electrode can be used to monitor the ECG of the subject. The therapy may also include a defibrillation pulse. The therapy electrode may also include an electrically conductive gel reservoir that releases an electricallyconductive gel onto the surface of the conductive layers. The acoustic sensors may be mechanically connected to the layer or electrically coupled. Through a cap that houses the conductive gel reservoir, the acoustic sensor can be acoustically connected to the surface. An internal surface of the cap may be used to attach the acoustic sensor. The cap may have an upper wall that houses the acoustic sensor. An acoustic sensor can be attached to the cap’s upper wall. This will allow it to record sounds indicative of heartbeats. A connector or signal conductor may be used to electrically connect the acoustic sensor and a circuit board to the therapeutic devices. The connector or signal conductor is coupled to the therapeutic devices with enough slack for the therapy electrodes to flex. The extending connector may also be used to provide the slack along a multi-dimensional path.

“Some embodiments include an adhesive layer that is used to attach the device to the subject.”

“In some embodiments, a controller is added to the therapeutic device to prompt the subject’s verbal response before delivering a therapy. In some embodiments, a defibrillation pulse may be used. The controller can also be configured to halt the delivery of therapy when the subject’s voice is detected by the acoustic sensors. The controller can be programmed to distinguish between the subject’s voice and the voice of another person detected by the acoustic sensors. The controller can be programmed to respond to the detection of voice of subject by the microphone and the detection of voice of another person by the acoustic detector.

“According to another aspect of this disclosure, an electrode assembly is provided that comprises a substrate and an electrically conducting layer. The electrode portion of an electrode assembly is formed by the electrically conductive layer. The first surface of the electrically conductive layer can be placed next to a patient’s skin. An impedance reduction system is also included in the electrode assembly. This system is designed to apply an electricallyconductive gel to the first surface of the layer. In response to an activation signal, an acoustic sensor is attached to the electrode portion of electrode assembly. An ECG sensing electrode may be included in the electrode assembly to monitor the patient’s ECG.

The acoustic sensor could include a multi-channel, three-axis MEMS accelerometer. A three-channel accelerometer may be included in the acoustic sensor. One embodiment uses a three-channel accelerometer to monitor the sounds of the heart. A second channel is used to monitor the patient’s respiration. The third channel is used to monitor the patient’s movement.

“In some embodiments, an acoustic sensor can be electrically connected to a system that records signals indicative of sounds generated by the heart of the patient. The system can also be configured to analyze signals indicative of sounds produced by the patient’s heart. The system could also be configured to alert the patient if the heart sounds are indicative of an abnormal cardiac condition.

“In some embodiments, an impedance reduction device includes a conductive jelly reservoir that can be used to store a portion of the electrically-conductive gel that will be applied to the first surface of the electrically conducting layer in response to activation signals. Through a cap that covers the conductive gel reservoir, the acoustic sensor can be acoustically connected to the electrically-conductive layer. The cap may have an internal wall that connects the acoustic sensor to it mechanically. The cap may have an upper inner wall that houses the acoustic sensor.

“According to another aspect of this disclosure, there is a method for monitoring physiological parameters in a subject.” This method involves monitoring the heart sounds of the subjects using an acoustic device physically coupled to a therapeutic electrode or defibrillation electrode. The acoustic sensors also monitor at least one additional parameter related to the state of the subjects using the acoustic sensors, which may include one or more parameters associated with respiration, gastrointestinal sounds, and body movements.

“In some embodiments, at least one additional parameter may include the body position of the subject. One parameter that is associated with the subject’s respiration may include sounds and movements of the chest. Monitoring at least one parameter that is related to a subject’s state may include monitoring two or more parameters.

“In accordance to another aspect of this disclosure, there is a method for monitoring physiological parameters in a subject. This method involves providing a therapeutic device, such as a therapy or defibrillation electrode, with at least one audio sensor that is acoustically coupled. The at least 1 acoustic sensors are configured to monitor the heart sounds and at least one additional physiological parameters of the subjects. These include one or more of the following: gastrointestinal sounds, respiration, body movements, and snoring.

“The present invention’s aspects and embodiments are not limited to the construction details and arrangement of the components described in the following description, or illustrated in the drawings. This invention can be practiced in many different ways and has other embodiments. The terminology and phraseology used in this document are for descriptive purposes only and should not be considered as restrictive. The use of the word?including? ?comprising,? ?having,? ?containing,? ?involving,? ?involving,?

“The wearable medical devices 100 include a number of therapy electrodes (114a,114b) that are electrically connected to the control unit 120 via connection pod 130. They are capable of delivering one to three therapeutic defibrillating shocked to the subject if necessary. Other embodiments of the therapy electrodes can provide additional forms of therapy such as electrical pacing to the subject’s heart or stimulating nerves with electric current as part of Transcutaneous Electrical Nerve Stimulation therapy (TENS). The plurality of therapy electrodes comprises a first therapy electrode (114a) that is placed on the subject’s front and a second therapy device (114b) that is located on the subject’s back. The second therapy electrode (114 b) includes a pair therapy electrodes that are electrically connected together and serve as the second therapy 114.b. Two therapy electrodes 114a,114b allow a biphasic to be delivered to the subject’s body. One therapy electrode may deliver a phase of the biphasic shocked with one therapy electrode acting to return. The other therapy electrode may deliver the second stage of the biphasichock with the return therapy electrode. The belt 110 may be positioned higher than the FIG. 1. so that the plurality ECG sensing electrodes 112 as well as the plurality therapy electrodes (114 a,114 b) are generally placed in a plane intersecting with the subject’s heart. One or more ECG sensing electrodes 112 or therapy electrodes 114a,114b may be equipped with an adhesive layer to help hold the electrodes in the correct position.

The connection pod 130 connects the plurality ECG sensing electrodes 112 and the plurality therapy electrodes (114 a,114 b) to the control 120. It may also include electronic circuitry. One example is the connection pod 130, which includes signal acquisition circuitry. This may include a plurality differential amplifiers that receive ECG signals from different ECG sensing electrodes 112 in order to generate a differential ECG signal for the control unit 120 based upon the difference. Other electronic circuitry may also be included in the connection pod 130, such as an accelerometer or motion sensor that can monitor subject activity.

“In some embodiments the therapy electrodes (114a,114b) may be multi-purpose electrodes. The therapy electrodes 120 a, 114b can deliver a shock to the subject, and may also provide electrical pacing or TENS therapy.

“As shown at FIG. “As shown in FIG. 1, the wearable medical devices 100 include a user interface pod 140, which is electrically connected to the control unit 120. A clip (not shown), that attaches to a section of the interface pod 140, can be used to attach the user interface pod 140 to the subject’s clothing. The user interface pod 140 can also be carried in the hand of a person. The user interface pod 140 can communicate wirelessly with control unit 120 in some embodiments. This could be done using Bluetooth?, Wireless USB? ZigBee or Wireless Ethernet? GSM or another type of communication interface. The user interface pod 140 usually includes a number of buttons that the subject, or bystander, can use to communicate with control unit 120. A speaker is also used by control unit 120 to communicate with the subject and the bystander. If the control 120 detects that the subject has cardiac arrhythmia and issues an audible alarm (not shown), the control 120 can issue an alert to the subject and anyone else who may be watching. To indicate consciousness, the control 120 may instruct the subject to press the buttons on the control 120 or the user interface pod 140 and hold them. This will instruct the control 120 to stop the delivery of therapeutic defibrillating shockeds. The device can assume that the subject is not responding and continue with the treatment, which may include the delivery of one or several defibrillating shots to the subject’s body. The functionality of the user interface pod 140 can be integrated into control unit 120 in some embodiments.

It has been found that analysis of sounds 101 produced by a subject’s cardiac muscle due to electro-mechanical activity can provide valuable information about the health of their heart. This data can be combined with or substituted for ECG data to provide information such as a warning sign of potential cardiac problems or a possible impending event, such as cardiac arrest. To determine if a subject’s cardiac condition has improved or worsened, the analysis of his heart sounds may be performed over longer time periods, such as days, weeks or months. U.S. Pat. describes some of the systems and methods that can be used to analyze the sounds of a subject’s hearts and the information this analysis might provide. Nos. Nos. 7,302,290 and 7,668,589 are included herein as references in their entirety.

“In some embodiments, the wearable medical device 100 may also include or replace ECG sensing electrodes 112. 3A) to detect the sounds made by the subject’s hearts. One or more parts of the wearable medical devices 100 may have an acoustic sensor or an audio transducer 260. The acoustic sensor or audio transducer 260 can be placed within the harness 110, or connected to one of the ECG electrodes 112 or therapy electrodes (114 a,114 b). The acoustic sensor or audio transducer 260 can be placed on or within electrodes that are located on the front, back, or sides of a subject. The electrodes that attach to the harness 110 may hold the electrodes against the skin of a subject who is wearing the wearable device 100. 4). 4).

“In some embodiments, it may be desirable for the acoustic sensors(s), or audio transducer (s) 260 to be located proximate or in contact with the subject’s skin so that heart sounds can be detected more easily than if they were further away from the subject. The acoustic sensors or audio transducer 260 may be acoustically connected to the subject’s heart, even though they are not physically in contact with his skin. It may be desirable for the audio transducer (or acoustic sensor) to be located near or in contact with the subject’s skin. This is to ensure that the sounds of the heart are not diminished by travel through the body. An electrode portion of the therapy electrode assembly 100 in a wearable device 100 may be placed above the subject’s heart and in contact with their skin. In some embodiments, an acoustic sensor (or audio transducer) 260 may be placed on or within the electrode portion of a therapy electro assembly that is located close to the subject’s chest, such as proximate his left ventricle.

“The control unit 120 could include a memory unit that records data about the heart sounds. Some embodiments may store recorded heart sounds data on removable memory cards, such as an SD card. The control unit’s processor may use the recorded heart sounds to detect potential heart problems. The data concerning the heart sounds can be sent to an external system for analysis and processing. This can be done wirelessly or via a wired connection to an outside system.

“Feedback102” may be given to the subject via a speaker or display on the control unit 120, if the analysis 101 of the subject?s heart sounds provides an indication of a problem or a possibility of an impending cardiac event (e.g., cardiac arrest). You can also access the results of the analysis by the subject’s heart sounds through an external device. For example, you may be able to view the results through a website or display of an external system.

Two normal heart sounds are present in healthy adults. They are commonly called S1 and 2. S3 is a third sound that can be heard in the heart and may indicate a problem. S3 can be associated with abnormal diastolic filling patterns in older subjects (e.g., those over 40). S3 could indicate cardiac problems such as a failing left ventricle or dilated congestive hearts failure. S4 is a fourth sound in the heart, also known as a presystolic or atrial gallop. It can indicate a problem with the heart. S4 can be associated with stiffness in the left ventricular. Some subjects may experience heart murmurs, which could indicate cardiac problems.

The acoustic sensor(s), or audio transducer(s), 260, and the associated recording and analysis systems can be configured to detect and record any or all of S1, S2, S3, or S4. The heart sound recording and monitoring systems can also record other parameters such as electromechanical activation (EMAT), percentage (% EMAT), and left-ventricular systolic (LVST) heart sounds. EMAT is measured between the onset and closure of the mitral valle within the S1 sound. Extended EMAT has been linked to a lower left ventricular ejection percentage (LVEF), which is a measure of how blood is being pumped from the left ventricle of your heart with each contraction. % EMAT equals EMAT divided by dominant RR interval. The efficiency of the pump function of your heart is reflected in % EMAT. SDI is a multiplicative mixture of ECG sound parameters (EMA and S3). SDI is a highly specific method of predicting left ventricular dysfunction. The time interval between the heart sounds S1 and S2 is called LVST. It is the systolic part of the cardiac cycle. LVST is subject to some heart rate dependence and can be as high as 40% (30-50%) of the cardiac cycle. However, it can also be affected by diseases that cause poor contractility or a low ejection percentage.

“Data concerning any one or more of these heart sound parameters can be recorded and displayed in trend charts. This data may be accessed by the subject or care provider via the control unit 120, or another device. You may also set control limits for any of these parameters. The control unit 120, or an external system to whom the heart sound data are transmitted, may compare the measured (or calculated) parameters to determine the control limits. If any of these limits is violated, a warning can be given to the subject via a speaker, display of the control 120, or user interface pod 140.

“In certain embodiments, the audio transducer(s), 260 or acoustic sensor(s), 260 may be set up to recognize the voice of the subject wearing the wearable medical devices. A patient voice signature may then be used as a response mechanism. The control unit 120’s processor may be trained to recognize the voice and use speech recognition and voice analysis techniques. The control unit 120 can then prompt the subject to say a predetermined phrase or word, such as through a speaker or display. If the control 120 detects that the subject has cardiac arrhythmia the control 120 may emit an audible alarm through a speaker (not illustrated) on the control 120 or the user interface pod 140, alerting the subject as well as any other bystanders about the subject’s condition. The control unit 120 can also instruct the subject that they speak a word, phrase, or combination thereof. This information is transmitted to the control 120 by the audio transducer(s), 260, and is used to notify the control 120 that the subject is awake. The device can assume that the subject is not responding and continue with the treatment sequence. This may include the delivery of one or several defibrillating shots to the body.

The control unit 120 can be set up to distinguish between the voice and voice of the subject. This could include a professional EMT, first responder, bystander or passerby. The control unit 120 can analyze the voice of a person who speaks in response to a prompt to determine if it is the voice of the subject. The control unit 120 may ask the subject to repeat the instructions, repeating them if it is the voice from another person. To make sure that the subject follows the instructions, the control unit can modify the instructions to ask for silence from others around it. The control unit 120 can monitor the audio transducer(s), 260 or acoustic sensor(s), 260 for signals from other people proximate to the subject. The control unit 120 can detect the voice of another person and issue instructions to the subject. This may be done through a speaker, or through a display. The control unit 120 can alter the course of treatment. For example, it may postpone or abort delivery of one or more defibrillating shots to the body of the subject. It may also provide data about the subject’s condition. If, for instance, the control unit 120 detects the voice of a person, the bystander responds by pressing the control unit 120 to indicate that professional assistance has arrived to help the subject. The control unit 120 may change to an alternate mode of operation if professional assistance is detected. In this case, the ambulatory treatment device 100 and the monitoring device 100 will support the medical assistance.

As mentioned above, wearable medical devices, such as a defibrillator or wearable ECG sensing electrode, are worn almost continuously by subjects to protect against cardiac arrest. The wearable medical device is often worn almost continuously so dry electrodes can be used for the plurality ECG sensing electrodes 112. and the plurality therapy electrodes (114 a,114 b) for comfort and skin irritation. The control unit 120 sends a signal (114 a,114 b) to the plurality therapy electrodes to release an impedance-reducing gel before delivering one or more shocks to the body. The impedance-reducing gel lowers the resistance between the electrodes’ conductive surfaces and the skin of the subject, improving the energy delivery and decreasing the risk of skin irritation (e.g., burning, reddening or other forms of irritation).

“FIG. 2A is a plan of the electrode portion of a therapy electrode array that includes an impedance-reduction system. It can be used with a wearable device such as the wearable cardiac defibrillator discussed above in relation to FIG. 1. FIG. FIG. 2B shows a functional block diagram for the impedance reduction device that is part of the electrode portion of therapy electrode assembly. 2A. 2A. The electrode portion 200 is made up of a multi-layered laminated structure. It includes an electrically conductive layer (not visible in FIG. 2A, but located on the bottom of the embodiment electrode portion 250 shown at FIG. 2D), which forms the electrode and an impedance-reduction system 201. The electrically conductive layer should be placed adjacent to the subject’s skin. However, portions of harness 110 (FIG. 1. and/or portions may be placed between the electrically-conductive layer and subject’s skin. FIG. FIG. 2A shows that the impedance reduction device 201 is located on the electrode portion 200 (i.e. the top-side in FIG. 2A) is on the opposite side of the conductive layer.

“The impedance reducing system 201 contains a plurality conductive gel reservoirs210 that have a respective gel delivery outlets 220. They are fluidly coupled with a fluid channel (230) and a fluid source (240). The fluid pressure source (240) is fluidly coupled with the fluid channel 233. An activation signal activates the channel 230 and forces a fluid such as nitrogen gas into it. Hydraulic pressure from the activated fluid source 240 in fluid channel 230 forces the conductive jelly stored in each of these gel reservoirs out through the plurality o gel delivery outlets 220. Through apertures in the electrically conductive layer, the liquid is forced onto the exposed surface. This layer, which is in use, is located most closely to the subject’s head. The plurality of gel outlet 220 are aligned with the apertures in the electrically-conductive layer so that the electrically active gel is dispersed onto the electrode portion closest to the subject’s body when activated. U.S. Pat. 200 provides more information about the construction of electrode portion 200. No. 5,078,134 (hereinafter ?the ‘134 patent?) which is incorporated by reference herein

“FIG. 2C shows an electrode portion 250 of an assembly that includes an acoustic sense 260. FIG. FIG. 2C. 2C. FIG. 2C illustrates the acoustic sensor 265. 2C as it is inserted within a cap 215. Enclosing one conductive gel reservoir 210 of electrode portion 250 What is the cap 215? The cap 215 is made of a sound conducting material such as a hard plastic. What is the cap 215? FIG. 2C shows the cap as transparent. 2C to show the position of the Acoustic Sensor 260. The acoustic sensors 260 and 215 are mechanically and acoustically connected to the upper interior wall of the cap. An adhesive, such as epoxy or another type of glue, or one or more mechanical fasteners (e.g. snaps, tabs or any other fasteners) can be used to attach the acoustic sensor 260 to the cap 215? The shell 215 contains the conductive gel reservoir 215. The acoustic sensor 265. The acoustic sensors 260 are positioned and configured to be acoustically connected to the subject to whom the electrode portion 250 has been applied. The shell 215 may be used to acoustically couple the acoustic sensors 260 to the bodies of subjects to whom the electrode portion 250 has been applied. The substrate 280. You can facilitate acoustic coupling by minimizing or eliminating any gaps between the shell 215 and 260. and the shell 215? The electrode portion 250’s substrate 280. To cover the electrode portion’s upper surface 250, a protective cover 290 may be used. It may be made from foam rubber.

“The cap 215. Housing the acoustic sensors 260 can be formed differently from caps 215 that enclose the conductive gel reservoirs210 of the electrode portion 250. The cap 215 could be an example. An upper wall that includes the acoustic sensors may be flattened in order to allow for the attachment of the 260. Caps 215 that do not contain acoustic sensors might have substantially rounded upper wall.

“A connector, or signal conductor, 270 provides an electrical connection between the acoustic sensors 260 and the circuit board 275. It is connected to the electrode portion 250. Some embodiments of the signal conductor are coupled to the electrode portion 250 by an adhesive, one or more mechanical fasteners, or both. FIG. 2C shows that the signal conductor may have some slack. This could be done by routing it along a multi-dimensional path so that the electrode portion 250 can be flexed without being detached from the circuit board 275 or acoustic sensor 265. For electrode portions 250 that have been specifically designed to allow for greater flexibility, such as one or more of those disclosed in co-owned U.S. Pat. No. No. 8.880,196, titled FLEXIBLE THEAPY ELECTRODE. This is incorporated herein in its entirety.

“In other embodiments the acoustic sensors 260 could be found on or near the electrode portion 250. FIG. 3B shows that the acoustic sensors 260 can be placed on a portion 280 of the electrode portion 250. Alternate embodiments of the acoustic sensors 260 can be placed anywhere it can acoustically couple with a subject’s body. The electrode portion 250 can include one acoustic sensor, as shown, or multiple acoustic sensing devices 260.

“The acoustic sensors 260 can include any device that detects sounds from the heart of a subject and provides an output signal responsive. The acoustic sensors 260 may include a microphone. The acoustic sensor 262 may include an accelerometer. The acoustic sensor 260 may comprise a microelectromechanical system (MEMS) accelerometer. The acoustic sensor 262 may include a multi-channel accelerometer. An acoustic sensor could include a three-channel accelerometer that senses movement in each of the three orthogonal directions. A LIS344ALH accelerometer from STMicroelectronics, is an example of an accelerometer that may be used in certain embodiments. The acoustic sensor 262 and its associated electronics can be used to monitor a subject?s respiration, heart sounds, position, activity, and other parameters. Other sounds that could indicate a subject’s health, such as snoring, stomach sounds, or gastrointestinal sounds, may also be monitored by the acoustic sensors 260 and their associated electronics. The acoustic sensors 260 can provide signals indicative that the subject’s respiration is being monitored on one channel and signals indicative that the subject’s heart sounds are being monitored on another channel. Signals indicative of the subject?s position on a third channel may also be provided. Other embodiments may use the various channels to indicate signals indicative of multiple physiological parameters or other parameters related to the subject’s state. In one embodiment, the acoustic sensors 260 might provide signals that indicate the subject?s heart beat on a first channel and signals that indicate the subject?s respiration on another channel. Signals indicative of the subject?s body position on any of the channels, first, second, or third, may also be provided by the sensor. Multiple signals related to the parameter being monitored can be received on a single channel, or over multiple channels depending on the parameter. In some cases, the associated electronics and acoustic sensor 262 can also detect sounds that indicate the release or inactivation of conductive liquid from the electrode portion 250 of a therapy electrode assembly.

Further, an accelerometer may be used to enable the acoustic sensors 260 and associated electronics to indicate whether an electrode assembly with the acoustic sensing has been properly placed on a subject. The acoustic sensors 260 and associated electronics can be used to detect, for instance, the direction of Earth’s gravity and the orientation of acoustic sensors 260. This may also indicate the location of the therapy electrode assemblies. The acoustic sensors 260 and associated electronics can be used to determine if the therapy electrode assembly was correctly placed on a subject, or if it has been placed incorrectly, such as in an inverted position.

The acoustic sensor 2260 and the electronics that are associated with it may be used to detect if CPR is being administered to the subject. If so, the signal will be sent to indicate the result. Electronics associated with the acoustic sensors 260 can be used to analyze motion related to CPR. For example, they may measure the depth and rate of chest compressions. An acoustic sensor may be attached to a portion or a position on a therapy electrode assembly. This could be, for example, on a tab that extends from electrode portion 250 or on a position on a wearable medical instrument 100. The position would be close to the xiphoid (116) of the subject when the device is worn by the subject. 1. This would enable the placement of an acoustic sensors to measure the depth of chest compressions while administering CPR. It could also detect if CPR is being administered. The electronic components of the acoustic sensor 262 may provide feedback to the person performing CPR. This could be done through one or more indicators, or through a speaker. This will allow for more efficient administration.

“Applicants recognize that redundancy may be desirable in some instances of the impedance-reduction system described above. Co-owned U.S. Pat. reveals electrodes that include redundant impedance reduction system. No. No. 8,406,842, which is incorporated herein in its entirety.”

“FIG. 3A shows an electrode assembly which combines one or several ECG sensing electrodes with a therapy electrode and redundant impedance reducer systems into a single integrated assembly according to a further aspect. The electrode assembly 400 has two pairs of ECG sensing electrodes 412a, 412b to monitor the cardiac function of the subject. Further, the electrode assembly 400 includes a therapy electrode 414 and at least two impedance-reduction systems 301, 302. An insulator may be used to electrically separate the pair of ECG sensing electrodes 412a, 412b from the therapy electrode 414. In other embodiments of the electrode assembly 400, only one ECG sensing electro may be used, while other embodiments may contain more than two ECG sensing devices. These alternative embodiments may have different placements and numbers of ECG sensing sensors than the FIG. 3A. Another embodiment of the integrated electrode assembly may contain additional sensors 416. These sensors, in addition to the ECG sensing electrodes, therapy electrode and one or more ECG electrodes, are capable of monitoring physiological parameters such as blood pressure, heart rate (or pulse oxygen level), heart rate, respiration rate, heart sounds, heart beat, heart rate, etc. One or more acoustic sensor 260 may be included in the additional sensors 416.

The electrode assembly 400 can be worn on the body of the subject such that one of two ECG sensing electrodes 412a, 412b is placed in the middle of the subject’s chest, while the other electrode 412a, 412b is on the side. FIG. 4. The electrode assembly 400 can be worn on the front side of the subject’s body, with the ECG sensing electro 412a positioned in the middle of the chest and the other 412b on the left. Another electrode assembly 400 is also available. A second electrode assembly 400 may be worn on the backside of the subject’s body to provide a second pair ECG sensing electros 412a?, 412b?. 400? is located in the middle of the subject’s back. The other ECG sensing electro (for example, ECG sensor electrode 412b?) is placed at the same location. The second pair of ECG sensing electrodes 400? is placed on the subject’s right side opposite the other ECG sensor electrode (e.g., ECG sensing electro 412b) of the first ECG sensing pairs 412a, 412b, as shown in FIG. 4. This arrangement allows for a front-to back pairing of ECG sensing electros (for instance, 412a, 412a? You can also have a side-to -side pairing of ECG sensing electros (for instance, 412a, 412a?). You should know that there are other options for the first and second electrode assemblies 400 and 400. Alternate placements may be possible. The first electrode assembly 400 could be placed on the one side of the subject’s body, while the second electrode assembly 400 is placed on the other. To provide side-to side pairings of ECG sensing electros, the second electrode assembly 400 may be placed on the opposite side of the subject.

“The first and the second electrode assemblies 400, 400?” The electrodes assemblies 400, 400 may have an electrically conductive adhesive coating. They can be attached directly to the skin of the subject, or attached to the harness, as shown in FIG. 1. and held against the subject’s torso. If only one electrode assembly contains an acoustic sensors 260, the electrode assembly can be placed so that it is located proximate to the subject’s heart.

“In further embodiments acoustic sensors 265 for monitoring any parameter described herein, such as sounds associated with a subjects heart, respiration, orientation, or movement associated with administering CPR to a patient, can be included in electrodes with shapes and materials of different construction from those shown in FIGS. 2C and 2D. 2C and 2D. The functionality of acoustic sensors 260 in electrodes is not limited to one particular type or form.

“Having described at least one aspect of the invention, it is to been appreciated that many alterations, modifications, or improvements can be made by those who are skilled in this art. These modifications, alterations, and improvements are included in this disclosure and are considered part of the scope of the invention. The above description and drawings should be considered an example.

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