Patent Description:
Heart failure and other chronic conditions are a major health concern worldwide. Heart failure is a progressive disease with varying symptoms such as fatigue, coughing, diminished exercise capacity, shortness of breath, fluid retention, swelling in the abdomen or legs, lung congestion, and cardiac arrhythmias. Heart failure can be treated, and its symptoms mitigated, by lifestyle modifications, medications, surgical procedures such as heart transplants, and mechanical therapies.

These efforts can come with side effects and limited success rates. Heart failure continues to reduce the quality of life of victims.

<CIT> discloses a wearable defibrillator that consists of a vest (or belt) which is worn by the patient. The device monitors the patient's ECG with sensing electrodes and can monitor other patient conditions and in appropriate cases can treat certain conditions. <CIT> disclose a personal wearable pacer/cardioverter/defibrillator which monitors a patient's condition, detects shockable or paceable arrhythmias, determines consciousness, and, in the case that the patient is determined to be unconscious, administers therapy to the patient.

The present invention is a wearable treatment device for treatment of a subject as it is defined in claim <NUM>. The device monitors and collects health related information from the subject, and uses this information to determine if treatment is warranted, to suggest lifestyle modifications, and to adjust treatment regimens. The device can further include an external defibrillator to apply treatment such as defibrillation to the subject when necessary. By monitoring a subject's conditions in a nearly continuous fashion in essentially real time, a comprehensive medical record of the subject can also be developed on a long term basis, for further treatment and analysis.

In various embodiments, the alarm module can provide a second instance of the alarm after the treatment is applied to the body of the subject. The user interface can prevent application of the treatment to the body of the subject. In one embodiment, the treatment device includes a second sensor. The second sensor can be positioned outside the body of the subject and can detect subject activity and wellness information. The controller can determine that the treatment device is properly positioned on the subject based at least in part on a position of the first sensor and a position of the second sensor.

In some embodiments, the controller can provide at least one of the cardiac information and the subject activity and wellness information to a computer server via a network. The controller can also generate a report based on the cardiac information and the subject activity and wellness information. The report may suggest a change in at least one of a treatment regimen, an exercise regimen, and a diet regimen.

In various embodiments, a wearable treatment device is provided that includes a cardiac sensing electrode, a treatment electrode, a user interface, a sensor; and a controller. The cardiac sensing electrode and the treatment electrode are positioned outside the subject. The sensor is positioned to detect the subject activity and wellness information of the subject, and the user interface receives the quality of life information. In some embodiments, the wearable treatment device substantially continuously senses at least one of cardiac information and subject activity and wellness information, and provides at least one of the cardiac information and the subject activity and wellness information to a computer server via a network. The wearable treatment device can also generate a report based on the cardiac information and the subject activity and wellness information, or suggest a change in at least one of a treatment regimen, an exercise regimen, and a diet regimen.

In some embodiments, instructions are provided to operate the wearable treatment device. The instructions include at least one instruction to position at least one of the cardiac sensing electrode and the sensor on the subject. The instructions can also include at least one instruction to position the wearable treatment device on the subject.

Other aspects, embodiments, and advantages of these exemplary aspects and embodiments are discussed in detail below. Both the foregoing information and the following detailed description are illustrative examples of various aspects and embodiments, and are intended to provide an overview or framework for understanding the nature and character of the claimed aspects and embodiments. The accompanying drawings are included to provide illustration and a further understanding of the various aspects and embodiments, and are incorporated in and constitute a part of this specification. The drawings, together with the remainder of the specification, serve to explain the described and claimed aspects and embodiments.

The systems and methods described herein are not limited in their application to the details of construction and the arrangement of components set forth in the description or illustrated in the drawings. The use of "including" "comprising" "having" "containing" "involving" and variations thereof herein, is meant to encompass the items listed thereafter, equivalents thereof, and additional items, as well as alternate embodiments consisting of the items listed thereafter exclusively.

Various aspects and embodiments are directed to a wearable treatment device that senses information about a subject's condition. This information includes cardiac information, subject activity and wellness information, and subject quality of life information. This information can be aggregated into reports on the subject's condition that can be used to provide or adjust treatment regimens. An alarm module can indicate that treatment has been, is being, or will be applied.

<FIG> illustrates wearable treatment device <NUM> configured for a subject to wear as a garment. The subject includes a person receiving health care, such as a subject who may or may not be under supervision of a doctor or health care provider. The subject may be in or out of a hospital setting, and the subject can engage in day to day life activities, at home, work, leisure, and play while wearing treatment device <NUM>. Treatment device <NUM> includes monitoring, treatment and data transmission and processing capability, and can be worn as a vest, belt, shirt, or series of straps, garment, or undergarment for example. Treatment device <NUM> may include at least one power supply such as a battery, or other power supplies, including AC power supplies and uninterruptable power supplies. Treatment device <NUM> can monitor and treat cardiac ailments such as heart failure, as well as other medical conditions such as arrhythmias, pulmonary ailments, other heart irregularities, sleep disorders, and circulatory system deficiencies such as blockages.

In one embodiment, treatment device <NUM> includes dedicated control logic devices that collectively constitute a control system, such as at least one controller <NUM>. Controller <NUM> can include programmable logic devices and arrays, application specific integrated circuits, hardware and software combinations, general purpose processors and dedicated controllers, for example. Further, treatment device <NUM> may include graphical user interfaces or other interfaces to provide output information and receive input information from a user. Controller <NUM> can be contained entirely within treatment device <NUM>, or at least partially located external to treatment device <NUM>, such as at a remote computer server in a doctor's office, data center, or other location. In one embodiment, controller <NUM> includes at least one processor as described in commonly owned U. Patent Application <CIT>. The referenced application generally discloses a processing architecture configured to conserve energy.

Treatment device <NUM> can also include a plurality of sensors <NUM>, <NUM>. The plurality of sensors <NUM>, <NUM> may include subject medical condition sensors <NUM>, such as cardiac sensing electrodes, and subject activity sensors <NUM>, such as motion sensors or accelerometers. While four external medical condition sensors <NUM> are illustrated in <FIG>, treatment device <NUM> can include more or less than four external medical condition sensors <NUM>, and in some embodiments, sensors <NUM> include at least one internal sensor or external dry electrode. Sensors <NUM> may include at least one cardiac sensing electrode to detect a subject's cardiac information related to the subject's heartbeat or electrical activity of the subject's heart. Sensors <NUM> are configured for placement proximate to the subject, for example, about the subjects torso, chest, back, limbs, or neck, where they can sense information about the subject's bodily functions. In one embodiment, sensors <NUM> include a fingertip pulse oximeter that can generate a photo plethysmograph to measure blood flow, blood oxygen saturation, respiration, or hypovolemia. In other embodiments, sensors <NUM> can include sensors that monitor or measure wellness information indicative of a general wellness of the subject, such as pulse, breathing, temperature, blood pressure, or fatigue information, for example.

In one embodiment, the plurality of sensors <NUM>, <NUM> includes subject activity sensors <NUM>. In one embodiment, subject activity sensors <NUM> can include at least one accelerometer to detect subject movement, lack thereof, or positional orientation. Sensors <NUM>, <NUM> that include subject activity sensors generally detect tangible medical or physical condition or information indicative of a subject's overall health, as well as statistically significant changes in measurements or conditions with time that may indicate changes in the subject's health, such as a worsening heart failure condition.

Treatment device <NUM> may also include at least one treatment electrode <NUM>. In one embodiment, treatment electrode <NUM> is configured to deliver shocks or electric current to the subject, such as a defibrillation shock applied to resuscitate a subject during cardiac arrest or another cardiac event. Treatment electrodes <NUM> may be housed in therapy pads that also include receptacles to house conductive fluid such as conductive gel. For example, treatment electrodes <NUM> may include dry treatment electrodes. In this example, prior to treatment, controller <NUM> can direct the receptacle to burst, releasing conductive fluid that contacts a surface of treatment electrode <NUM> as well as the subject's skin, enhancing the electrical connection between the subject and treatment electrode <NUM>. The receptacles can be replaced after use.

In one embodiment, treatment electrodes <NUM> are formed from plates of metal or other conductive material having a conductive surface and configured for contact with the subject. The therapy electrodes may have generally circular, oval, rectangular, square, or other geometric forms with a generally continuous surface. In some embodiments, treatment electrodes <NUM> are formed from conductive wire or thread sewn into treatment device <NUM> in stitched, woven, or intertwined patterns, including a mesh pattern. In one embodiment, treatment device <NUM> includes at least one node <NUM> to connect or interface with sensors <NUM> and treatment electrodes <NUM>. Node <NUM> may be located on a belt of treatment device <NUM> and can be part of or associated with controller <NUM> to facilitate communication between controller <NUM>, sensors <NUM>, <NUM> and treatment electrodes <NUM>. In one embodiment, node <NUM> is a device to physically couple cables <NUM> that connect controller <NUM>, sensors <NUM>, <NUM> treatment electrodes <NUM>, and other treatment device <NUM> components, such as at least one monitor <NUM>. <FIG> depicts three treatment electrodes <NUM>, with one treatment electrode positioned proximate to the subject's chest, and two treatment electrodes <NUM> positioned proximate to the subject's back. This configuration can be used to provide shocks to the subject's heart during defibrillation treatment. Other configurations and positions of treatment electrodes <NUM> are possible for defibrillation and other treatments.

In one embodiment, treatment device <NUM> includes at least one subject activity sensor <NUM>. For example, subject activity sensor <NUM> may include at least one accelerometer that can indicate accelerating and decelerating movements. For example, a subject wearing treatment device <NUM> can participate in normal activities, such as standing, walking, sitting, running, and generally moving about as part of day-to-day life when partaking in physical, labor, and leisure activities. Because of the nature of human movements, generally comprising short distance and short duration, accelerometers provide useful information about subject movement and activity. Controller <NUM> can use this information to determine if treatment is necessary or should be adjusted, if quality of life recommendations should be made to the subject (e.g., a suggestion to change dietary or activity habits,) or if a doctor should be consulted. In some embodiments, activity sensors <NUM> include single axis accelerometers as well as multi-axis sensors.

In one embodiment, the plurality of sensors <NUM>, <NUM> include at least one cardiac sensing electrode <NUM>, a subject activity sensor <NUM>, such as an accelerometer, or other sensor configured to provide information to controller <NUM> relating to the subjects cardiac information (e.g., ECG), or activity wellness (e.g., motion or position). For example, sensor <NUM> can sense and provide information about the subject's body state - e.g., vertical, horizontal, lying down on left side, lying down on right side, moving in a recitative pattern, vibrating due to environmental causes such as during a car ride, convulsing due to health causes such as a cardiac event or seizure, accelerating, decelerating, falling, and treatment device <NUM> component acceleration or mechanical shock, (e.g., sensor <NUM> disconnects from the subject and falls or impacts the ground or a hard surface due to gravitational or other forces).

In one embodiment, treatment device <NUM> includes two activity sensors <NUM>, such as accelerometers. For example, a first accelerometer can be located on node <NUM> and a second accelerometer can be located on monitor <NUM>. In one embodiment, the first accelerometer is positioned on the subject's upper body, and the second accelerometer <NUM> is positioned proximate to the subject's waist. Accelerometers or other activity sensors <NUM> may also be positioned on the subject's limbs. Activity sensors <NUM>, including accelerometers, may include at least one position, force, or motion detector. In one embodiment, controller <NUM> uses information detected by multiple activity sensors <NUM>, such as accelerometers to determine and predict subject activity, and to calibrate or verify the accuracy of sensors <NUM> and/or sensors <NUM>. For example, one or more of sensors <NUM> may be tasked with determining the subject's heartbeat, and may shift due to movement or be improperly positioned so that an inaccurate reduced heartbeat is sensed. In this example, activity sensors <NUM> may indicate that the subject is exercising and where an elevated heartbeat would be expected, while sensor <NUM> detects a reduced heart beat or no heart beat because it is improperly positioned on the subject. Controller <NUM> can identify this discrepancy and notify the subject, for example by a display on monitor <NUM>, that one of sensors <NUM> should be repositioned. By processing sensed information and information received from the user, controller <NUM> may also determine that treatment device <NUM> components have been tampered with or damaged, and monitor <NUM> can display a notification of any such tampering or damage. In one embodiment, controller <NUM> is located together with monitor <NUM>.

In one embodiment, controller <NUM> evaluates activity sensor <NUM> information to determine the position of the subject and any corresponding applied forces. For example, activity sensor <NUM> can measure x, y, and z axis orientations of the subject. Controller <NUM> can use this information in a confidence based arrhythmia detection algorithm to accelerate or delay the timing of treatment based on past and present body motion or position history. Multiple activity sensors <NUM> permit separate evaluation of different subject movements and controller <NUM> evaluates subject movements to determine subject activity, create a real time and comprehensive subject medical record, and to recommend, apply, or adjust treatment regimens. The treatment applied can depend upon the diagnostic requirement of the subject's doctor and the condition of the subject (e.g., heart failure or congestive heart failure) that the doctor or the subject wishes to monitor.

In one embodiment, activity sensors <NUM> include at least one accelerometer to sense high sensitivity subject activity and wellness information, such as breathing or other generally subtle forms of motion such as body position (e.g., standing or prone). Sensors <NUM>, <NUM> can detect and monitor physical activity and activity trends, body positions, and sleep conditions, such as sleep apnea. For example, sleep apnea may be deduced based on pulse oximetry and respiration measurements. Sensors <NUM> can also include at least one accelerometer to measure low sensitivity data such as mechanical shock.

In some embodiments, activity sensors <NUM> include at least one multi-axis accelerometer, or two three-axis accelerometers with one of the accelerometers mounted on a vest portion of treatment device <NUM> and another of the accelerometers mounted elsewhere on treatment device <NUM>, such as a strap about the waist, or on monitor <NUM>, which can include a visual display where the orientation of the visual display is controlled by the output of accelerometer.

In one embodiment, treatment device <NUM> includes at least one monitor <NUM>, which can include at least one touch screen, buttons, or other user interface such as a keyboard. The user interface may have multilingual audio and visual displays.

Monitor <NUM> can also be remote from treatment device <NUM>. Monitor <NUM> can display information to indicate that treatment device <NUM> is or is not properly configured about the subject. For example, monitor <NUM> can indicate that sensors <NUM>, <NUM> are properly positioned and operational. Monitor <NUM> can attach to a belt or other portion of treatment device <NUM>. In one embodiment, monitor <NUM> can be exposed, external to the subject's clothing, with at least some other treatment device components (e.g., sensors <NUM>, <NUM>) concealed beneath the subject's clothing. In one embodiment, treatment device <NUM> includes two monitors <NUM>, with a first monitor housed on treatment device <NUM>, and a second monitor remote to treatment device <NUM>. The second monitor can communicate with controller <NUM>. In one embodiment, the second monitor displays additional information that the first monitor does not display. For example, the second monitor can be part of a base station or a battery charger that includes a processor and memory. The second monitor can also be a personal computer monitor, (e.g., laptop, desktop, tablet, or mobile telephone monitor) configured to display the subject's historical medical record and other long term noncritical information, and the first monitor can be a dedicated application specific monitor that is housed on a belt of treatment device <NUM> configured to input and output core data related to the subject's present cardiac condition, general wellness, quality of life, and treatment regimen.

In one embodiment, monitor <NUM> displays medication reminders to prompt the subject to take medication. For example, monitor <NUM> can display visual information (that can be supplemented with audio information) telling the subject what medication to take, and when. In one embodiment, monitor <NUM> shows the subject what the medication (e.g., a pill) looks like (for example, by color, shape, markings, etc.), and issues a verbal prompt to remind the subject to take a certain medication and a certain time. After taking the medication, the subject can inform treatment device of this fact via a user interface of monitor <NUM>.

Monitor <NUM> may also include an alarm module. The alarm module can be audio, visual, tactile, or haptic, and can alert the subject as well as bystanders that treatment device <NUM> has applied, is applying, or will apply electric current or other treatment to the subject. The alarm module can also provide indicators of the subject's condition, such as heart or respiration rates, volume, or timing, or the subject's pulse, as well as heart failure indicators and coronary sounds.

In one embodiment, the alarm module provides an alarm after sensor <NUM> detects cardiac information about the subject, and before treatment device <NUM> applies treatment to the subject. The alarm module can also provide a further alarm after treatment has been applied to the subject. For example, the alarm module can alert first responders that at least one defibrillation shock has already been applied by treatment device <NUM>. The alarm module can also alert bystanders or rescuers that it is safe to contact the subject after treatment has been applied, or that another round of treatment (e.g., another shock) is forthcoming. In one embodiment, the alarm module indicates that treatment will be applied. When the subject does nothing to abort the forthcoming treatment (such as depressing an abort switch or entering instructions via the user interface,) controller <NUM> can instruct treatment device <NUM> to administer an electric shock to the subject via one of treatment electrodes <NUM>.

In <FIG>, a first activity sensor <NUM> such as an accelerometer is located in front of the subject, for example attached to monitor <NUM>, and a second activity sensor <NUM>, such as an accelerometer is located in back of the subject, for example attached to a belt of treatment device <NUM>. Other configurations of accelerometers are possible, in front, in back, and on the sides of the subject, and attached to different belts, straps, or other components of treatment device <NUM>. Wire <NUM> allows communication and data transfer between activity sensor <NUM>, medical condition sensors <NUM>, and controller <NUM> via node <NUM>.

<FIG> depicts a block diagram of treatment device <NUM>. As illustrated in <FIG>, controller <NUM> includes a microcontroller and a system computer, with the microcontroller associated with node <NUM> and the system computer associated with monitor <NUM>, and with wire <NUM> connecting the microcontroller with the system computer. Different configurations are possible. For example, more than one logic device can collectively constitute controller <NUM>, and controller <NUM> may be part of treatment device <NUM>. In one embodiment, at least some logic devices of controller <NUM>, such as the system computer, are located external to treatment device <NUM>. For example, both monitor <NUM> and the system computer can be separate from treatment device <NUM>. Such external components may communicate with the microcontroller or other elements of controller <NUM> that are part of or housed on treatment device <NUM> via wire <NUM> or other connections, both wired and wireless. In one embodiment, the microcontroller process real time information related to the subject's cardiac information, quality of life, general wellness, and treatment regimen; and the system computer processes information related to the subject's long term medical history. For example, controller <NUM> can provide information to a remote computer via a wireless transmission to generate a comprehensive real time medical history of the subject when, for example, the subject wears treatment device <NUM> for any period of time. This medical history information may be stored in memory that is part of treatment device <NUM>, or remotely, for example in a hard drive of a computer in a doctor's office. The system computer and the microcontroller can exchange information and instructions regarding treatment application and adjustment. In one embodiment, controller <NUM> communicates a message to a physician, responder, bystander or the subject to indicate that treatment is imminent, being provided, or has already been provided.

In one embodiment, controller <NUM> communicates with a central server that is external to treatment device <NUM>. For example, sensed indicators of heart failure can be wired or wirelessly downloaded to a central server for processing, and presented to a doctor for review and analysis. This information can be tailored to a doctor's needs, for example to generate alerts and notifications. With respect to data gathering, reference is made to <CIT>, which is assigned to the assignee of the present application. The referenced application generally discloses remote transmission and collection of data received from patient-worn medical devices.

In one embodiment, a first activity sensor <NUM>, such as an accelerometer, is attached to node <NUM> and a second activity sensor <NUM>, such as another accelerometer, is attached to monitor <NUM>. Sensed information from both of these sensors <NUM> can be transferred to controller <NUM>, which can be physically attached to treatment device <NUM>, or remote from treatment device <NUM>. In one embodiment, treatment device <NUM> includes two accelerometers to determine parameters such as subject body position, body movement, and body acceleration, and to perform self-diagnostics. Monitor <NUM> can contain either a high-G or a low-G accelerometer, or both. In one embodiment, a high-G low-sensitivity accelerometer can detect subject and equipment physical shock to determine if treatment device <NUM> is damaged.

Activity sensors <NUM> can detect movement and orientation of the subject. In one embodiment, controller <NUM> processes information from two activity sensors <NUM>, such as accelerometers <NUM> to identify subject activity. Processing of accelerometer data can be performed by the microcontroller or the system computer.

Accelerometers can indicate change in the subject's velocity. For example, the subject can have an activity level when conscious that includes changes in both velocity and direction. By contrast, an unconscious subject may have little or no change in body motion. Other activity sensors <NUM> (e.g., gyroscope, magnetometer, hall-effect devices, pedometers, global positioning systems, and other force motion or position sensors) can indicate motion or lack of motion. Outputs from sensors <NUM> may be integrated, compared or differentiated by controller <NUM> to predict subject activity, and reduce interference or error signals.

<FIG> depicts a block diagram of a treatment device <NUM>. In one embodiment, AC or DC power supply <NUM> (e.g., a power cord to AC main lines, or a battery) can power treatment device <NUM> components, such as controller <NUM>, monitor <NUM>, and sensors <NUM>, <NUM>. At least one power regulator <NUM> can control the power from power supply <NUM>.

In one embodiment, controller <NUM> controls various system parameters such as activity sensor sensitivity, multiplexer (MUX) <NUM> channel select, the analog to digital converter (ADC) <NUM>, and serial communication with controller <NUM> via serial communication bus <NUM> to acquire data from activity sensors <NUM> and to display this information at monitor <NUM>. MUX <NUM> and ADC <NUM> can be internal to controller <NUM>, or can be separate components. In one embodiment, activity sensors <NUM> include a Freescale Semiconductor MMA7260Q three axis low-g micromachined accelerometer. The g-select control line <NUM> coupled to controller <NUM> and the accelerometer allows the sensitivity to be varied from, for example, <NUM> to <NUM>. A high-G low sensitivity accelerometer can also be used to allow subject/equipment shock to be detected. Resistor-capacitor (RC) filter <NUM> can connect to outputs of the accelerometer to minimize clock noise from the accelerometer internal switched capacitor filter circuit. Controller <NUM> can control select lines of multiplexor <NUM> and may allow each axis output of the accelerometer to be switched to the Analog to Digital Converter (ADC) <NUM> input. Controller <NUM> can also control ADC <NUM> via a serial interface. In one embodiment, sensors <NUM>, <NUM>, controller <NUM>, and monitor <NUM> sense, process, and display other information such as sensed cardiac information, sensed general wellness information, and subject inputted self assessment entries including quality of life information.

<FIG> depicts an alternative block diagram of a treatment device <NUM> where controller <NUM> acquires information from activity sensor <NUM>, such as an accelerometer. Power supply <NUM> can be used to power the components of treatment device <NUM>. Activity sensor <NUM> can include a Freescale Semiconductor MMA7260Q three axis low-g micromachined accelerometer. Controller <NUM> controls the g-select lines that again can allow the sensitivity to be varied from, for example, <NUM> to <NUM>. RC filter <NUM> as well as amplitude scaling can be applied to each of the accelerometer outputs. In one embodiment, MUX <NUM> and ADC <NUM> are internal to controller <NUM> the analog outputs of the accelerometer are interfaced digitally directly to the controller <NUM>.

In one embodiment, controller <NUM> detects an arrhythmia by assigning various confidence coefficients or weighting values to the various sensors <NUM>, <NUM>) that communicate with controller <NUM>. In one embodiment, this is done prior to controller <NUM> determining a confidence level that detected motion indicates true motion, and not a false positive motion indication due, for example, to an incorrectly placed or dropped activity sensor <NUM>. For example, controller <NUM> can separately analyze two independent ECG data streams from sensors <NUM> to extract heart rate, morphology, frequency information, general wellness, and other information. Controller <NUM> can perform additional analysis, independently on each channel, to analyze the signal for noise contamination that may result from subject motion or biological signals such as muscle noise. Secondary inputs to the basic detection algorithm can include a subject response button or override switch, where for example the subject indicates that they are in motion, and inputs from activity sensors <NUM>. In one embodiment, controller <NUM> determines that the lack of response from the subject, for example, by not pressing a subject response button (e.g., an abort switch,) that can be part of treatment device <NUM>, means that the subject is unconscious.

In one embodiment, a weighting value is assigned to each sensor <NUM>, <NUM> and the response button to make the decision that a treatable arrhythmia condition exists. In addition, the weighting values can be used to manipulate or adjust the timing and nature of therapy delivered by therapy electrodes <NUM>.

During use by a subject, there may be instances where a first ECG channel contains noise and a second ECG channel is clean. For example two pairs of sensors <NUM> can independently obtain ECG signals, with one pair being contaminated with artifacts and the other being clean. The two ECG signals can be obtained simultaneously or sequentially, and can be transmitted to controller <NUM> via the same or different communication channels (e.g., wire <NUM>). In one embodiment, controller <NUM> places more weight on the clean ECG channel. For example, to enhance a confidence level of the sensed information, a weighting can be assigned that would delay delivery of treatment by treatment electrodes <NUM> while sensors <NUM> and controller <NUM> determine if there is subject motion.

The flow diagram in <FIG> shows that if subject motion is detected prior to the detection of a treatable arrhythmia, the timing of treatment delivery can be modified based on activity sensor <NUM> inputs when the arrhythmia is detected. If the subject becomes motionless coinciding with the arrhythmia detection, there is an increased confidence that the arrhythmia diagnosis is accurate and the delivery of treatment can occur sooner. If motion continues after the arrhythmia detection, the confidence of a valid detection can be decreased because lethal arrhythmias generally result in a lack of consciousness and lack of motion. In this case, the delivery of treatment can be delayed to allow time for audio voice messages to prompt the subject to respond by pressing the response button. The response button provides a responsiveness test input to the algorithm. In some embodiments, it may be desirable to never deliver a shock to a conscious subject. This method can reduce the possibility of false treatment based on invalid rhythm diagnosis due to corrupt ECG inputs caused by excessive subject movement or other environmental factors.

<FIG> illustrates arrhythmia detection with increased confidence by serially feeding through a subsequent confidence algorithm using input from activity sensor <NUM>, such as a motion detector or accelerometer. Other motion detecting devices or confidence algorithms can use various motion detection criteria as desired by physicians and based upon the treatable condition or subject. The motion data can also be stored, tracked and evaluated, for example to evaluate a subject's historical motion or activity levels to detect conditions such as congestive heart failure. Such diseases can be found in subjects wearing treatment device <NUM>.

In one embodiment, treatment device <NUM> includes sensors <NUM> to monitor the subject's cardiac information. For example sensors <NUM> can include cardiac sensing electrodes that are positioned external to the subject to detect the subject's cardiac information. Controller <NUM> processes the sensed cardiac information to detect life-threatening arrhythmias, and can instruct treatment electrodes <NUM> to deliver treatment, such as a cardio verting or defibrillating shock. Treatment device <NUM> can also include a user interface to receive quality of life information. For example, the subject can enter information about the subject's lifestyle, eating and exercise habits, and how the subject currently feels. Additional sensors <NUM>, <NUM> can detect subject activity or other wellness information, such as respiration or pulse rates, or temperature. In one embodiment, this subject activity and wellness information is discrete information that can be measured or sensed by sensors <NUM>, <NUM>, as opposed to quality of life information that may be of a more general nature such as what the subject ate or how the subject feels, or more subjective information provided by the subject or the subject's physician.

In one embodiment, treatment device <NUM> includes at least one treatment electrode <NUM> configured for external positioning proximate to the subject. Controller <NUM> communicates with sensors <NUM>, <NUM> including sensors configured to sense cardiac information (e.g., cardiac sensing electrodes) and sensors configured to detect subject activity and wellness information, (e.g., accelerometers). Controller <NUM> can also communicate with the user interface of monitor <NUM>. Controller <NUM> receives detected cardiac information, (ECG signals), detected subject activity and wellness information, and inputted quality of life information to determine if treatment is to be applied to the subject. Controller <NUM> can also adjust a treatment regimen, for example by advancing or delaying its application by treatment electrodes <NUM>. For example, controller <NUM> can decide to apply treatment (e.g., an electric shock from therapy electrodes <NUM>) based on sensor <NUM>'s detected cardiac information,) and can adjust the treatment regimen based on sensor <NUM>'s detected subject activity and wellness information or based on the quality of life information provided by or on behalf of the subject via a user interface. In one embodiment, controller <NUM> adjusts therapy based on the subject's level of activity over a period of time, where information from sensors <NUM> is used to determine the subject's level of activity.

In one embodiment, controller <NUM> controls the nature and application of a treatment regimen based on information from any of sensors <NUM>, <NUM> (including, for example, cardiac sensing electrodes, other sensing electrodes, accelerometers), treatment electrodes <NUM>, the user interface of monitor <NUM>, and other inputs of the subject's cardiac information, subject activity and wellness information, and quality of life information. Based on this information, controller <NUM> can determine a treatment regimen (e.g., what type of treatment) and determine that the treatment has, is, or will be applied. Based on this information, controller <NUM> can also adjust the treatment regimen or the application of the treatment. Controller <NUM> can also control an alarm module to alert the subject or others of past, present, or pending treatment.

In one embodiment, medical condition sensors <NUM> and controller <NUM> can detect and identify heart failure indicators such as heart or respiratory rates. The subject or a service provider can view a chart or graph based on the sensed information that tracks heart failure indicators over time. The display can be on a monitor that is remote from treatment device <NUM> via wired or wireless communication over a network, or local to treatment device <NUM> as part of monitor <NUM>. Controller <NUM> can generate reports that summarize trends or indicators for one or more subjects. Heart failure indicators above or below a certain threshold value can trigger an alert notification to the subject via the alarm module or to a remote doctor. The heart failure information sensed by medical condition sensors <NUM> can be provided to the subject or a doctor in the form of a report, either on demand or periodically as part of a routine notification schedule. The report can be sent by text message, page, automated phone call or email, and can flag trends in the subject's condition, noting changes, trends, and exceptions as they occur.

Subjects wearing treatment device <NUM> may suffer from heart failure and develop pulmonary edema, which involves the buildup of extravascular fluid in the lungs, (e.g., congestion). Fluid can pool in blood vessels in the lungs and become a barrier to normal oxygen exchange. In one embodiment, medical condition sensors <NUM> monitor impedance of the subject's thoracic cavity and controller <NUM> processes this sensed impedance information to detect the presence or absence of pulmonary edema, which may be an indicator of heart failure. A reduction in sensed thoracic impedance indicates an increase in thoracic fluid, and fluid depletion in the thorax indicates an increase in thoracic impedance.

In one embodiment, controller <NUM> and sensors <NUM> or treatment electrodes <NUM> sense and measure transthoracic impedance. This data can be collected because the subject can wear treatment device <NUM> substantially continuously for extended periods of time. Controller <NUM> can average transthoracic impedance measurements over time to identify extravascular fluid buildup. By comparing the averaged measured values with thresholds, treatment device <NUM> can alert the subject or a doctor of changes in the subject's condition so that treatment or medical advice can be provided.

In one embodiment, treatment device <NUM> measures and records respiration data by monitoring transthoracic impedance changes. For example, impedance increases as air fills the lungs, and decreases when air is exhausted from the lungs during exhaling. By monitoring these and other changes with medical sensors <NUM> (e.g., cardiac sensing electrodes, pulse oximeters,) and activity sensors <NUM> (e.g., accelerometers, strain gauges, pedometers, nasal clips, expandable belts, monitoring of elastic movement of treatment device <NUM>,) controller <NUM> can determine the subject's respiration rate, stride, pulse, and other information. Information sensed by sensors <NUM>, <NUM> can be transmitted over a network (e.g., the Internet) to a doctor on demand or as part of a periodic report. The doctor can evaluate this information to make a diagnosis.

Treatment device <NUM> can sense and monitor a variety of conditions and trends, such as atrial fibrillation, nocturnal heart rate, respiration rate, pulmonary sounds, heart sounds, activity trends, body position trends, heart rate variability, heart rate turbulence, and bradycardia events. For example, controller <NUM> can processes information detected from sensors <NUM>, <NUM> (e.g., ECG signals, accelerometer information, or sound information) to detect any of these conditions. In one embodiment, medical condition sensors <NUM> include an ECG sensing electrode system that, together with activity sensors <NUM> and controller <NUM>, detect and record metrics associated with the minimum heart rate value that typically occurs during sleep, as well as diurnal heart rate. In one embodiment, sensors <NUM> include an auscultation sensor that records chest and lung sound recordings to identify fluid content in the lungs. In addition, sensors <NUM> can detect wheezing and coughing that can indicate fluid buildup and a worsening condition. In one embodiment, activity sensors <NUM> can detect movement that occurs during coughing to verify an indication of a cough detected by an audio sensor. Controller <NUM> may also analyze sensed heart audio signals to identify changes in cardiac performance.

In one embodiment, treatment device <NUM> detects activity or body position trends, and analyzes this information to determine the subject's condition. Controller <NUM> may make this analysis, or may communicate the sensed information to a computer server, where the information is analyzed remotely. For example, the physical activity of a subject with heart failure may decrease as the heart failure condition worsens. General subject activity and movement can indicate whether the heart failure conditions are getting better or worsening, and can indicate whether treatment is working. For example, information from activity sensors <NUM> may be used to generate activity trends of the subject's activity level (e.g., increasing with time, decreasing with time, remaining substantially constant). This information can be generated over long periods of time when the subject is wearing treatment device <NUM>. In one embodiment, activity sensors <NUM> sense subject activity, including body movement and positioning throughout the day and during sleep. Sleep positioning information may include the angle of the subject body during sleep, as sleeping in an inclined position (e.g., on a reclining chair) can indicate worsening heart failure. For example, an increasing sleep angle with time combined with decreasing activity can indicate worsening hear failure.

Treatment device <NUM> may detect heart rate variability, heart rate turbulence, or bradycardia. For example, medical condition sensors <NUM> may measure sympathetic and parasympathetic nervous system activity, and controller <NUM> may identify heart rate variability based on R-R intervals in ECG signals or a spectral analysis of heart rate variable frequencies. Information about these systems may be aggregated over time to identify trends.

In one embodiment, treatment device <NUM> is configured for self assessment entries by the subject. For example, a user interface that forms part of monitor <NUM> can receive quality of life information such as symptom information, body weight, and blood pressure by prompting the subject for these entries. Other self assessment entries that include quality of life information can be provided at selectable intervals, such as daily. Examples of these questions that prompt self assessment entries include: How do you feel today? How is your breathing today? Are you tired today? What is our weight today? What is your blood pressure today? What did you eat today? The subject may select from a standard list of responses, for example by indicating "worse" "the same" or "better. " The subject may enter a number on a scale, for example from one to ten, or may enter measured values, for example of the subject's weight or blood pressure. In one embodiment, at least some of this information is sensed by sensors <NUM> or other devices, such as scales or blood pressure monitors. The subject can enter this information over the Internet, monitor <NUM>, or a display on a battery charger unit given to patient, for example. Interfaces used for the entry of this information may be part of or remote from treatment device <NUM>.

In one embodiment, wearable treatment device <NUM> includes biometric monitoring of the subject wearing treatment device <NUM> during initial risk assessments and during the course of treatment of a condition such as heart failure. Treatment device <NUM> monitors heart failure indicators and the onset of symptoms, and presents this information in a selectable and customizable form to a doctor in a periodic manner, at the doctor's choosing, or as an alert when a time sensitive condition may require quick treatment. Treatment device <NUM> can present this information in the form of aggregated reports that include trends with time of the subject's condition. In one embodiment, this information is aggregated in an omnibus quality of life score based on a plurality of sensed conditions. This aggregate score can be compared with a threshold value to indicate whether or when the subject requires treatment.

In accordance with an embodiment of the invention, to gather data under controlled conditions the subject undertakes physical activity, such as a six minute walk test that measures how far the subject can walk in six minutes. In this example, the subject wears treatment device <NUM> during the six minute walk test. In accordance with an embodiment of the invention, via monitor <NUM>, treatment device <NUM> guides or prompts the subject throughout the test, while protecting the subject from, for example, cardiac arrest by providing an external defibrillator. Medical condition sensors <NUM> (e.g., pulse oximeters) and activity sensors <NUM> such as pedometers can measure the subject's distance traveled, stride distance, respiration, heart rate, ECG, blood oxygen saturation, and recovery time before, during, and after the six minute walk test. The doctor can use this information to evaluate a treatment regimen or track the subject's progress. For example, the six minute walk test can be administered before and after changes to the subject's treatment regimen to evaluate the subject's progress and the efficacy of treatment. In one embodiment, the six minute walk test is modified to determine energy spent by the subject during the six minute walk, for example based on x, y, and z direction accelerometer measurements taken during the test. The subject can wear treatment device <NUM>, and treatment device <NUM> can apply treatment to the subject, during the test.

In one embodiment, treatment device <NUM> tracks the subject's exercise regimen. For example, when the exercise is walking, cycling, or aerobic activity, treatment device <NUM> tracks duration, distance covered, heart rate, date, respiration rate, transthoracic impedance, walking angle, heart rate variability, time spent exercising, the subject's ECG, and post-exercise recovery time. Treatment device <NUM> can capture this information continuously during exercise and can present this information to a doctor for analysis and record keeping. In one embodiment, treatment device <NUM> alerts the subject that it is time to exercise at a determined date or time. Treatment device <NUM> may also identify a target heart rate (or range) and prompt the subject in real time to exercise with greater or lesser intensity in order to maintain a heart rate substantially at the target heart rate and to properly warm up and cool down before and after exercising. The target range can be adjusted based on information provided by sensors <NUM>, <NUM>.

Throughout the exercise regimen, treatment device <NUM> can monitor, record, and report information related to the subject's activity together with date and time information. Reports or summaries of this subject activity can be provided to a doctor, and can flag for the doctor's attention any conditions or changes that may have occurred during exercise.

Treatment device <NUM> may also act as a diet monitor that sets up and tracks the subject's eating habits. This information can be reported to a doctor. In one embodiment, treatment device <NUM> monitors a treatment regimen that includes special dietary guidelines, such as a low fat, low calorie, or low salt diet. The subject can enter information about the food the subject is eating in real time, via a user interface of monitor <NUM>. In one embodiment, the user interface includes a bar code scanner to scan packaged food bar codes and retrieve their nutritional information from a database. In some embodiments, treatment device <NUM> monitors the subject's diet and weight in parallel and adjusts a recommended diet regimen of the subject to adjust or maintain the subject's weight. For example, treatment device <NUM> can normalize food intake to overall subject energy, deduced by controller <NUM> from accelerometer readings, over a period of time to identify a diet regimen.

Further examples of the information sensed and evaluated by the components of wearable treatment device <NUM> include the following:.

Activity sensors <NUM>, such as an accelerometer can be used to determine a subject's body state during the detection of an arrhythmia. They can also be used to detect if a mechanically noisy environment is the cause of erroneous arrhythmia detection.

In one embodiment, a confidence algorithm, which can be influenced by many inputs including the subject's body state as determined by activity sensors <NUM>, is used to determine if a subject's heart arrhythmias requires defibrillation by treatment device <NUM>.

In one embodiment, cardiac treatment is not required if the subject is conscious and occurs only when the subject is unconscious. By using activity sensors <NUM> the subject body state can be monitored. In one embodiment, when there has been no change in subject body state for a period of time as detected by activity sensors <NUM> then there will be an increased confidence of the algorithm that the subject is unconscious. For example, if a change in subject body state is detected by activity sensors <NUM>, such as an accelerometer, then there will be a decreased confidence of the algorithm that the subject is unconscious. Treatment device <NUM> can adjust the treatment regimen to, for example, hasten the application of treatment if a high level of confidence exists that the subject is unconscious. If subject motion is detected while other sensors <NUM> and algorithms processed by controller <NUM> indicate that a treatable rhythm is present, treatment delivery can be delayed to provide the subject additional time to respond to system messaging.

Controller <NUM> can detect a false arrhythmia due to physical motion. For example, sensors <NUM> or wire <NUM> can move against the body or clothing, creating false deviations in the subject's ECG. If an arrhythmia is detected and vibration or high subject/equipment acceleration is detected, then the subject can be alerted to this condition. Monitor <NUM> or an alarm module can notify the subject. This information may also be applied to the treatment confidence algorithm thereby causing a decrease in confidence given that the physical motion can cause a false positive detection. Use of activity sensors <NUM> can reduce undesired treatment of false arrhythmias.

Motion of the belt or other treatment device <NUM> component may cause interference with ECG signal pickup and possible false detections. The signals obtained from activity sensors <NUM> or other sensors <NUM> can be correlated with an ECG signal to determine if ECG signal contamination exists. The quality of the correlation can be used by controller <NUM> as an additional confidence factor in the arrhythmia detection algorithm. If an arrhythmia is detected and there is a high degree of correlation between the ECG signal and a signal from activity sensor <NUM>, the confidence in the arrhythmia detection can be reduced. No signal correlation indicates increased confidence that the arrhythmia detection is accurate.

Activity sensors <NUM>, such as accelerometers may also be used to verify that a treatment has been applied by detecting sudden movements or muscle spasms in the subject immediately following the treatment. Often after defibrillation the subject's muscles spasm from the energy pulse. The muscle spasm can cause detectable movements on activity sensors <NUM> similar to convulsing.

Post shock motion of the subject after several unsuccessful defibrillation attempts may indicate the presence of bystanders. The bystanders could be rescue personnel such as an EMT. In this case monitor <NUM> or an associated alarm module can generate audio or visual alarms or voice messages to inform the bystander of the equipment and treatment status. Controller <NUM> can adjust the timing of additional shocks (for example by delaying or canceling them) to prevent a shock to the bystanders or rescue personnel.

When a shock is delivered, the subject may move suddenly and then return to a state where there is a lack of motion. If no further motion is detected, controller <NUM> can determine with a high confidence level that the arrhythmia is still present. This information can be used by controller <NUM> as an additional post- shock confidence factor for the detection algorithm and that a continuing cardiac condition exists. If post-shock motion continues or if the subject body position changes from a horizontal to vertical position, controller <NUM> can determine that there is high confidence that the defibrillation was successful and additional shocks or other treatment can be delayed. Based on post shock motion, treatment device <NUM> can also detect and control pacing of the subject.

Treatment device <NUM> may include a belt for proper positioning on the subject and to house treatment device <NUM> components. Overall belt quality can be examined by gathering data using activity sensors <NUM> during certain failure states such as sensor <NUM> fall-off and treatment electrode <NUM> fall-off detection.

If one of sensors <NUM> or treatment electrodes <NUM> falls off of the subject, controller <NUM> can record the subject's body state during the fall-off event based on information from sensors <NUM>, <NUM> or information input by the subject via a user interface. Subject positions include sitting up, lying down; left side, right side. If controller <NUM> identifies vibration or the subject falling then that information can be recorded and evaluated by controller <NUM> since it might be the cause of the falloff event. Over time, controller <NUM> can use this information to determine positions that may tend to cause fall-offs of treatment device <NUM> components. This information can then be used to improve the belt design reducing and possibly eliminating the fall-offs in those certain activities or positions. This information can also be used to train the subject and those assisting the subject as to how to wear and use treatment device <NUM> and its components, as well as to establish instructions for future use of treatment device <NUM>. An example would be if post analysis of data over a several month period of time shows that <NUM>% of ECG fall-offs occur when the subject is laying on their left side then the belt design on the left side could be examined to determine what might be making it susceptible to fall-offs in that subject position.

Activity sensor <NUM> data collected over time could also be used to inform subjects of body states that tend to be more comfortable. Subjects who have worn the device for an extended time will most likely have experimented with different positions (sleeping positions, sitting positions, etc.) and will tend to use the most comfortable ones. This data can be provided to controller <NUM>, stored, and used to improve the belt for the other positions and also provide recommendations to new subjects.

Data collected by sensors <NUM> during subject use can be used to improve the comfort of the treatment device <NUM> when worn by studying subject sleep habits, or habits during other selected activities. For example, if <NUM>% of the subjects tend to sleep on their right side then the assumption can be made that something about the belt makes it less comfortable for the subjects to lie on their left side. With this information controller <NUM> can determine what about that position causes the belt to be uncomfortable and engineering can be performed to improve treatment device <NUM> comfort.

Self diagnostics may also be provided such as a Belt Node Tactile Stimulator (vibration/acceleration) self test. For example, treatment device <NUM> may include a tactile stimulator or other subject notification device. The tactile stimulator may include a motor with an unbalancing weight on its shaft. When the motor is on, it causes the belt to vibrate much like a cell-phone in vibration mode. When the tactile stimulator is activated, an activity sensor <NUM>, such as an accelerometer in node <NUM> can detect vibrations from the tactile stimulator to verify that node <NUM> is vibrating and that the tactile stimulator is working. The tactile stimulator can be housed in node <NUM>, with monitor <NUM>, or the alarm module.

Controller <NUM> can use activity sensor <NUM> information to provide feedback to the subject regarding mechanical events, or to adjust audio volume outputs of the alarm module or monitor <NUM> based on the current state of the subject.

If certain mechanical conditions that may lead to equipment damage such as mechanical shock or vibration are detected by activity sensors <NUM> then the controller <NUM> can instruct monitor <NUM> or the alarm module to notify the subject of such conditions and advise the subject of the condition.

If monitor <NUM> or belt is dropped, or if they are hit with some other object causing a force greater than a predefined acceptable force, then monitor <NUM> or the alarm module can provide an audio, visual, or haptic indication to the subject that the event has occurred and warn against allowing such an event to occur again.

If continuous vibration above a certain predefined acceptable threshold is detected for a period of time, then monitor <NUM> or the alarm module may also provide a warning to the subject. Such vibration could lead to sensor <NUM> or treatment electrode <NUM> fall-off, or even cause false arrhythmia detection if enough physical motion is applied to the sensors <NUM>, treatment electrodes <NUM>, wires <NUM>, or other components.

If information from activity sensors <NUM> indicates that the subject's body state is unchanged for a period of time, and the subject is either lying or sitting down then controller <NUM> can determine that the subject is sleeping and can increase the audio volume output of any audio message if necessary to awaken the subject. Controller <NUM> may also enable the tactile stimulator to awaken the subject in the event of a critical audio message.

Information from activity sensors <NUM> can be used by controller <NUM> to determine the proper position of monitor <NUM> to deliver a visual message to the subject or for initial subject setup by care givers. For visual messages to the subject, since monitor <NUM> can be positioned approximately at the subject's mid section, the display of information by monitor <NUM> may appear upside down (rotated <NUM> degrees) with respect to monitor <NUM>. However, during setup, when the subject is fitted with treatment device <NUM> and when its components are positioned, monitor <NUM> could be held right side up in front of the skilled personnel. As a result, the display would be right side up.

Controller <NUM> can detect abuse of treatment device <NUM> and its components during use as well as during shipping. This abuse can be determined by parameters such as number of times dropped and intensity. Detection of abuse can trigger such actions as internal diagnostics, auto download, and equipment service recommendations.

If activity sensors <NUM> detect a mechanical shock, for example to monitor <NUM> above a pre-determined acceptable threshold, then controller <NUM> can identify and record a drop event. Other parameters such as date/time stamp and current operating mode can be identified and recorded as well. The date/time stamp can allow correlation between monitor <NUM> location and the damaging event allowing further information to be obtained using the carrier tracking numbers if such damage occurred during shipping.

If it is not during shipping and is during use of treatment device <NUM> by the subject, and there is some form of treatment device <NUM> malfunction after the drop then that could be tied to the root cause of the equipment failure. Such information could be used to advise subjects of the types of mechanical shocks that may damage the equipment or components of treatment device <NUM>. It also may be used to improve the robustness of the equipment to survive such forces in the future.

If activity sensors <NUM> records a mechanical shock above a predefined acceptable threshold, or if a predefined acceptable number of mechanical shocks have occurred, monitor <NUM> can display a message indicating that the equipment should be serviced. Controller <NUM> can also, during the next download, notify the manufacturer that treatment device <NUM> should be serviced.

Logic devices that are part of activity sensor <NUM>, monitor <NUM>, or node <NUM> may constitute at least part of controller <NUM>. If activity sensor <NUM> does detect an excessive mechanical shock on the belt or monitor <NUM> then controller <NUM> may initiate internal self-diagnostics. Activity sensor <NUM>, monitor <NUM>, and node <NUM> may include circuitry to allow most of its components to be tested with self diagnostics.

If there is a significant mechanical shock to treatment device <NUM> components or equipment such as the belt or monitor <NUM>, then controller <NUM> may communicate with the manufacturer via a communications network to request service.

Data provided by activity sensor <NUM> or medical condition sensors <NUM> can be measured and stored over time to study subject activity. Subject activity data can be used to provide feedback to doctors about a subject's specific condition.

After applying treatment, subject activity data taken before, up to, and including the event can be downloaded from treatment device <NUM> to a remote data storage unit. This information can also be recorded locally at treatment device <NUM>. This data can be collected among a plurality of subjects and used to make correlations between subject activity derived from sensors <NUM> and the probability of a cardiac event or other condition that requires treatment occurring. These correlations can be used to take precautionary measures with subjects who have similar activities as those who had past treatment events.

Subject activity data can be used over a period of time by doctors or data evaluation systems to determine if proper subject activity levels are met. For example, a doctor can analyze the data to determine that there is low subject activity, or that the subject is performing recommended exercises. The doctor can also monitor the subject's real time activity level and corresponding heart rate data.

Subjects who are experiencing congestive heart failure can be monitored for physical activity and at rest body position. Gradual reduction in subject activity indicated by lack of motion can indicate a worsening of the congestive heart failure condition. Body position at rest can also indicate subject deterioration if body position at rest is primarily vertical since congestive heart failure subjects may have difficulty resting in a horizontal position.

<FIG> depicts a flow chart for a method <NUM> of monitoring and treating a subject. In one embodiment, method <NUM> includes an act of sensing cardiac information of a subject (ACT <NUM>). For example, sensing cardiac information (ACT <NUM>) may include detecting ECG (electrocardiogram) signals or other information related to electrical or mechanical activity of the subject's heart. In one embodiment, dry external electrodes are configured external to the subject to sense (ACT <NUM>) cardiac information. Internal electrodes may be used as well. Sensors used to sense (ACT <NUM>) cardiac information can be part of a wearable subject treatment device that includes an external defibrillator. In one embodiment, sensing cardiac information (ACT <NUM>) includes sensing information indicative of heart failure or other medical conditions.

In one embodiment, method <NUM> includes the act of sensing at least one of subject activity and wellness information (ACT <NUM>). For example, internal or external sensors proximate to the subject's body can sense (ACT <NUM>) pulse, breathing, temperature, blood pressure, or fatigue information, for example. In one embodiment, sensing activity and wellness information (ACT <NUM>) includes detecting subject movement, lack thereof, position, or orientation. Sensing activity or wellness information (ACT <NUM>) may include detecting tangible medical or physical condition or information indicative of a subject's overall health, as well as changes in health-related measurements or conditions with time.

Method <NUM> may also include at least one act of receiving quality of life information (ACT <NUM>). The quality of life information may be received from the subject, or on the subject's behalf from a physician or someone acting on the subject's behalf. In one embodiment, quality of life information is received (ACT <NUM>) by a user interface of a wearable treatment device. For example, the quality of life information may be received (ACT <NUM>) via direct manual entry into the user interface, or remotely via one or more wired or wireless networks. Receiving quality of life information (ACT <NUM>) may include receiving information about the subject's lifestyle, such as dietary, activity, or exercise habits, when the subject last took a particular action, or information about how the subject feels.

In one embodiment, method <NUM> includes acts of determining whether or not treatment is to be applied (ACT <NUM>) and adjusting the determined treatment (ACT <NUM>). For example, treatment (e.g., an electric shock) can be determined to be applied (ACT <NUM>) based on the detected (ACT <NUM>) cardiac information. In this example, sensed (ACT <NUM>) cardiac information may indicate that the subject is experiencing a cardiac event and in need of pacing or defibrillation. Adjusting the treatment (ACT <NUM>) may include time shifting the application of the treatment, or delaying application of the treatment pending confirmation of the subject's condition, based on the subject's sensed (ACT <NUM>) activity and wellness information. For example, method <NUM> can determine (ACT <NUM>) that treatment is not to be applied due to a high heartbeat, when sensed (ACT <NUM>) subject activity and wellness information indicates that the subject is intensely exercising, and that this may be the cause of the elevated heartbeat. In this example, application of pacing or other treatment can be delayed (ACT <NUM>) until it is determined that the subject is no longer exercising yet still has an elevated heart rate.

In one embodiment, method <NUM> includes an act of providing an alarm (ACT <NUM>). For example, an alarm can be provided (ACT <NUM>) by alerting the subject or other person of treatment. The alarm may be audio, visual, haptic, or combinations thereof, and can alert the subject and others in the vicinity of the subject of a treatment regimen. In one embodiment, providing the alarm (ACT <NUM>) includes alerting a doctor or health care provider that treatment has, is, or will be applied to a subject where the doctor is located remotely from the subject. For example, the alarm may be provided (ACT <NUM>) when the subject is on the street, or at home. In this example, the alarm can be provided remotely via wired or wireless communications through a communications network to the doctor who may be present in a hospital or office.

In some embodiments, providing the alarm (ACT <NUM>) includes alerting the subject or other person of a treatment regimen subsequent to sensing the subject's cardiac information (ACT <NUM>). Providing the alarm (ACT <NUM>) may also include alerting the subject or other person of a treatment regimen prior to an act of applying treatment to the subject (ACT <NUM>). In one embodiment, applying treatment to the subject (ACT <NUM>) includes applying an electrical shock or current to the subject as part of a defibrillation or pacing treatment regimen. In some embodiments, applying treatment (ACT <NUM>) occurs subsequent to the act of alerting the subject or another person that treatment has been applied, is being applied, or will be applied.

<FIG> depicts a flow chart for a method <NUM> of monitoring and treating a subject. In one embodiment, method <NUM> includes an act of providing the wearable treatment device (ACT <NUM>). For example, providing the device (ACT <NUM>) may include providing a garment in the general form of a vest or shirt that may include at least one strap, belt, pocket or receptacle. In one embodiment, providing the wearable treatment device (ACT <NUM>) includes providing a device that includes a cardiac sensing electrode to detect cardiac information (e.g., ECG) of the subject, and a treatment electrode to apply electric current to the subject as part of, for example, a defibrillation or pacing treatment. Providing the device (ACT <NUM>) may also include providing a user interface to receive quality of life information from the subject. This may include factual data about the subject's lifestyle, as well as the subject's opinion as to how the subject feels or the subject's health. Providing the device (ACT <NUM>) may also include providing a garment with an activity sensor, such as one or more motion sensors or accelerometers to detect subject activity and wellness information indicative of a general wellness of the subject.

In one embodiment, providing the device (ACT <NUM>) includes providing a controller. The controller communicates with the cardiac sensing electrode, the treatment electrode, the user interface, and the sensor to receive the detected cardiac information, the quality of life information, and the detected subject activity and wellness information. The controller can also determine that treatment is to be applied to the body of the subject based upon the detected cardiac information, and can adjust the treatment based on at least one of the detected subject activity and wellness information and the quality of life information. In one embodiment, providing the device (ACT <NUM>) includes providing an alarm module. The alarm module can provide an alarm to indicate treatment has, is, or will be applied to the body of the subject.

In one embodiment, method <NUM> includes an act of providing instructions (ACT <NUM>). This may include providing instructions to operate the wearable treatment device. For example, providing instructions (ACT <NUM>) can include providing at least one instruction to position at least one of the cardiac sensing electrode, the therapy electrode, and the activity sensor on the subject, and any other device components on the subject. Providing instructions (ACT <NUM>) may also include providing instructions to wear or position the wearable treatment device or any of its components on the subject.

Having now described some illustrative embodiments of the invention, it should be apparent to those skilled in the art that the foregoing is illustrative and not limiting, having been presented by way of example. In particular, although many of the examples presented herein involve specific combinations of method acts or system elements, it is understood that those acts and those elements may be combined in other ways to accomplish the same objectives. Acts, elements and features discussed only in connection with one embodiment are not intended to be excluded from a similar role in other embodiments.

Note that in <FIG>, the enumerated items are shown as individual elements. In actual implementations of the systems and methods described herein, however, they may be inseparable components of other electronic devices such as a digital computer. Thus, actions described above may be implemented at least in part in software that may be embodied in an article of manufacture that includes a program storage medium. The program storage medium includes data signals embodied in one or more of a computer disk (magnetic, or optical (e.g., CD or DVD, or both)), nonvolatile memory, tape, a system memory, and a computer hard drive.

From the foregoing, it will be appreciated that the wearable treatment device described herein is worn by the subject and senses information about the subject's activity, wellness, and quality of life via direct sensing or user provided data entries. The treatment device can determine if treatment is needed based on the subject's physical condition, can adjust treatment regiments based on sensed information, and can apply treatment to the subject as necessary. The wearable treatment device can gather information about the subject's health in real time over a substantially continuous period. This information can be aggregated to form a comprehensive medical history of the subject, which can be used to determine if past treatment regimens are successful and if modifications should be made.

Any embodiment disclosed herein may be combined with any other embodiment, and references to "an embodiment," "some embodiments," "an alternate embodiment," "various embodiments," "one embodiment" or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment. Such terms as used herein are not necessarily all referring to the same embodiment. Any embodiment may be combined with any other embodiment in any manner consistent with the aspects and embodiments disclosed herein.

References to "or" may be construed as inclusive, so that any terms described using "or" may indicate any of a single, more than one, and all of the described terms.

Where technical features in the drawings, detailed description or any claim are followed by reference signs, the reference signs have been included for the sole purpose of increasing the intelligibility of the drawings, detailed description, and claims.

Claim 1:
A wearable treatment device (<NUM>) for treatment of a subject, comprising:
a plurality of cardiac sensing electrodes (<NUM>) configured to be positioned outside a body of the subject and to detect cardiac information of the subject;
a treatment electrode (<NUM>) configured to be positioned outside the body of the subject and to apply an electric current to the subject upon detection of when the cardiac information is indicative of a treatable cardiac arrhythmia condition;
an activity sensor (<NUM>) configured to be positioned outside the body of the subject and to detect activity information of the subject;
an alarm module configured to alert the subject that the electric current will be applied to the subject.
a user interface configured to receive user instructions to abort administration of the electric current to the subject; and
a controller (<NUM>) communicatively coupled to the plurality of cardiac sensing electrodes, the treatment electrode, the user interface, and the activity sensor, the controller configured to guide or prompt the subject throughout a predetermined test comprising a physical activity to be performed by the subject and to record activity information reflecting progress of the subject through the predetermined test based on signals from the activity sensor, wherein the controller is configured to record the cardiac information detected by the plurality of cardiac sensing electrodes during the predetermined test,
wherein the controller is configured to determine whether the treatable arrhythmia condition exists based on data received from the plurality of cardiac sensing electrodes, data received from the activity sensor, and the user instructions received from the user interface, and
wherein the controller is configured to adjust the timing of administration of the electric current when the activity sensor indicates that the subject is moving.