SYSTEMS AND METHODS FOR DETECTING HEALTH DISORDERS
RELATED APPLICATIONS
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional
Application Serial No. 61/653,844, titled "SYSTEMS AND METHODS FOR
DETECTING HEALTH DISORDERS," filed on May 31, 2012, which is hereby
incorporated herein by reference in its entirety.
BACKGROUND
Technical Field
Aspects of the present invention relate to medical devices, and more
particularly to apparatus and methods for detecting disorders and symptoms caused at
least in some instances by abnormal activity within the cardiovascular system.
Discussion of Related Art
Syncope may be defined as a transient loss of consciousness resulting from an
insufficient presence of oxygen in the brain. Typical symptoms progress through
dizziness, clamminess of the skin, a dimming of vision or greyout, possibly tinnitus,
complete loss of vision, weakness of limbs, and physical collapse. Syncope can be
caused by a number of cardiovascular, neurological, or other factors.
Although a syncopal event itself is not fatal by definition, the event may be
indicative of underlying cardiovascular dysfunction which can involve a high risk for
the patient to suffer a life-threatening arrhythmia, such as ventricular tachycardia,
ventricular fibrillation, bradycardia, or asystole.
Since loss of consciousness can be a symptom for a variety of conditions, the
patient requires a thorough examination and testing in order to determine the cause of
syncope. Traditional methods of evaluating a patient who presents with syncope
include a blood test, a tilt table test, an electrocardiogram ("ECG"), or a heart monitor
(e.g., a holier monitor, loop recorder, or event recorder). When performing the tilt
table test, the patient is strapped to a table, the table and the patient are reoriented
from a lying to standing position, and the patient is observed to determine if syncope
is triggered by body position.
When using a holier monitor, loop recorder or event recorder, the device
records the heart rhythm during daily activities over a period of time. Some recorders
allow the patient to place markers on recordings when certain events occur or allow
the patient to trigger a recording. These types of devices are typically worn between 1
and 60 days.
In many cases, the exact cause of syncope may go undetected. Syncope may
occur randomly, and it may not be possible to duplicate in a monitored setting.
SUMMARY
Embodiments disclosed herein utilize a non-invasive ambulatory device
capable of defibrillation (e.g., a wearable defibrillator or some other electrotherapy
device) to monitor for and detect events associated with cardiovascular instability,
such as syncope, caused at least in some instances by an abnormality within the
cardiovascular system. For instance, according to some embodiments, a patient who
presents with syncope is fitted with a wearable defibrillator. In these embodiments,
the wearable defibrillator monitors and records data descriptive of the patient's
activities and physiology.
In other embodiments, the wearable defibrillator analyzes the recorded data in
near real time. In these embodiments, responsive to detecting a pattern of data
associated with a symptom, the wearable defibrillator may address the symptom by
performing one or more intervening actions. Examples of these intervening actions
include treating the cause underlying the symptom and notifying an external entity
(e.g., the patient, a bystander, a caregiver, a medical professional, or another computer
system) of the detected symptom associated with data pattern.
Other embodiments manifest an appreciation that conventional tests, such as
the tilt test, are often ineffective in revealing the cause of syncope, and due to the fact
that syncope is a random, transient, and relatively low frequency event even for a
patient who is susceptible to it, it may require many days or weeks of monitoring
before the syncope causes can be recorded, detected and treated. Patients are usually
hospitalized for a couple of days to perform testing to rule out certain, specific
conditions; however, it would be too expensive to keep all patients with possible
syncope in the hospital to be monitored for longer periods. Therefore, patients will be
fitted with one of the above-described monitoring devices and discharged from the
hospital until either the nature of the syncopal event is defined, or the treating
physician deems it to be no longer of value. As mentioned previously, when a patient
is discharged from the hospital, they are at risk of potentially fatal events due to the
syncope or its underlying physiological cause.
Unfortunately, the current state of the art, as discussed above, only provides
for the monitoring and recording of these syncopal episodes, but does not provide any
means of protecting the patient who has been released from the hospital with a
recording device, but who is essentially unprotected from risk of mortality due to the
underlying causes of syncope.
Also, due to the large number of patients encountering syncope, as well as the
high risk profile for the implantation of implantable pacer/cardioverter defibrillators
(ICDs), these patients are not candidates for the widespread implantation of ICDs as a
prophylactic measure in the short term.
It would thus be desirable to have a system incorporating a wearable
therapeutic device that is comfortable to wear continuously for extended periods that
could both detect the onset of incipient syncope prior to loss of consciousness, as well
as treat other manifestations of the underlying condition and prevent the actual
occurrence of the syncope itself, and treat cardiac dysfunction.
According to some embodiments, a method of treating a patient presenting
with syncope is provided. The method includes acts of detecting, by a wearable
defibrillator, an event associated with syncope; storing, by the wearable defibrillator,
data descriptive of the event in association with an indication that the data includes
data descriptive of a syncopal event; and addressing the event.
In the method, the act of detecting the event may include an act of detecting a
cardiac arrhythmia. The act of detecting the cardiac arrhythmia may include an act of
detecting at least one of ventricular tachycardia, ventricular fibrillation, and
bradycardia and the act of addressing the event may include issuing a therapeutic
treatment. The act of issuing the therapeutic treatment may include an act of issuing
at least one of a pacing pulse and a defibrillation shock. The act of addressing the
event may include an act of issuing a notification to the patient and bystanders.
In the method, the act of detecting the event may include an act of identifying
a pattern of data including data received from a plurality of sensors. The act of
identifying the pattern of data may include identifying a pattern of data including data
received from at least one of an electrocardiogram sensor and a motion sensor.
According to other embodiments, a wearable medical device capable of
treating a patient presenting with syncope is provided. The wearable medical device
includes a memory storing event profile information, a battery, at least one treatment
electrode coupled to the battery, at least one processor coupled to the memory and the
at least one treatment electrode, and an event manager executed by the at least one
processor. The event manager is configured to detect an event associated with
syncope; store, in the memory, data descriptive of the event in association with an
indication that the data includes data descriptive of a syncopal event; and address the
event.
In the device, the event that the event manager is configured to detect may
include a cardiac arrhythmia. The cardiac arrhythmia may be bradycardia and the
event manager may be configured to address the event by issuing a therapeutic
treatment. The event manager may be configured to issue the therapeutic treatment
by issuing at least one of a pacing pulse and a defibrillation shock. The event
manager may be configured to address the event by issuing a notification to the
patient.
In the device, the event manager may be configured to detect the event by
identifying a pattern of data including data received from a plurality of sensors. The
event manager may be configured to identify the pattern of data by identifying a
pattern of data that includes data received from at least one of an electrocardiogram
sensor and a motion sensor. The event profile information may include information
descriptive of the pattern of data.
According to another embodiment, a method for protecting a patient
presenting with syncope from cardiac dysfunction is provided. The patient may have
been diagnosed as having experienced (a) cardiac syncope or (b) undiagnosed
syncope, for which a diagnosis of cardiac syncope cannot be clearly dismissed.
Patients likely to be diagnosed as such include, but are not limited to, patients meeting
one or more of the following criteria: a history, or family history, of cardiovascular
disease (e.g. coronary artery disease, heart failure, structural heart disease); abnormal
ECG findings (e.g. ischemia, dysrhythmias, conduction abnormalities); advanced age;
and low hematocrit count. The method includes identifying a syncopal event within
the patient's history, and providing, responsive to identifying the syncopal event, the
patient with a wearable defibrillator. The method may expressly exclude protecting a
patient presenting with syncope who has been definitively diagnosed as having
experienced non-cardiac syncope, including but not limited to patients having
suffered one of the following: vasovagal syncope; orthostatic syncope; carotid sinus
syncope; drug-related syncope; and seizure.
The method may further include an act of monitoring the patient's physiology
via the wearable defibrillator. The method may further include an act of contacting
the patient where monitoring reveals the presence of an arrhythmia.
In the method, the act of providing the patient with the wearable defibrillator
may not be responsive to a diagnosis of cardiac dysfunction. The act of providing the
patient with the wearable defibrillator may include an act of providing the patient with
a wearable defibrillator configured to exclusively identify and treat cardiac
dysfunction. The act of providing the patient with the wearable defibrillator may
include an act of providing the patient with a wearable defibrillator that includes a
long term wear electrode.
Still other aspects, embodiments, and advantages of these exemplary aspects
and embodiments, are discussed in detail below. Moreover, it is to be understood that
both the foregoing information and the following detailed description are merely
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
subject matter. References to "an embodiment," "some embodiments," "an alternate
embodiment," "various embodiments," "one embodiment," "at least one
embodiments," "this and other embodiments" 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 and may be included in
that embodiment and other embodiments. The appearances of such terms herein are
not necessarily all referring to the same embodiment.
Furthermore, in the event of inconsistent usages of terms between this
document and documents incorporated herein by reference, the term usage in the
incorporated references is supplementary to that of this document; for irreconcilable
inconsistencies, the term usage in this document controls. In addition, 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 principles and operations of the described and
claimed aspects and embodiments.
BRIEF DESCRIPTION OF DRAWINGS
The accompanying drawings are not intended to be drawn to scale. In the
drawings, components that are identical or nearly identical may be represented by a
like numeral. For purposes of clarity, not every component is labeled in every
drawing. In the drawings:
FIG. 1 is a schematic of one example of a wearable medical device controller;
FIG. 2 is a schematic of an exemplary wearable defibrillator;
FIG. 3 is a flow diagram of one example of a process for treating a patient
with a wearable defibrillator; and
FIG. 4 is a flow diagram of one example of a process of monitoring and
treating syncopal events.
DETAILED DESCRIPTION
Aspects and embodiments disclosed herein relate to apparatus and processes
for detecting, recording, and treating health disorders and symptoms that are known to
have many potential root causes. For instance, in at least one embodiment, a patient
presenting with a symptom, such as syncope, having many potential causes is fitted
with a wearable defibrillator that is configured to record data descriptive of the
patient's physiology and physical activities. In this embodiment, the recorded data is
analyzed to determine one or more root causes of the symptom.
For instance, the recorded data may be analyzed for aberrant patterns that
indicate abnormal physiological function. These aberrant patterns may occur prior to,
during, or after the onset of symptoms. Furthermore, the aberrant patterns may
include information that is descriptive of various physical phenomena gathered across
a variety of sensors. If aberrant patterns are found during this analysis, correct
diagnosis of the root cause or causes of the symptom may be expedited, thereby
allowing the patient to be quickly treated specifically for cause of the symptom. In
addition, if the aberrant patterns were not previously known to be indicative of a
potential root cause of the symptom, the aberrant patterns may be added to a
catalogue of predetermined patterns associated with a symptom.
More specifically, in some embodiments, a wearable electrotherapy device is
equipped with a near infra-red spectroscopy system for measurement of parameters
such as tissue oxygenation, pH and glucose levels. One example of such a
spectroscopy system is manufactured by Reflectance Medical. The spectroscopy
system may be utilized to provide an early warning of impending decompensation of
the sympathetic nervous system regulation of hemodynamics and heart function. If
sympathetic tone is found to be lacking, the wearable electrotherapy device may
initiate electrical therapy specifically designed to target the sympathetic tone of the
heart. One example of such a therapy is referred to as packet therapy, which is a
pulse train of high frequency DC pulses that provide pacing as well as stimulation of
the sympathetic tone of the myocardium. One form of packet therapy is described
further in co-pending Application Serial No. 10/868,395, entitled
"MICROPERFUSIVE ELECTRICAL STIMULATION," filed June 15, 2004, which
is hereby incorporated herein by reference in its entirety.
Degradation of a patient' s condition into syncope is typically multifaceted as
well as extending over a period of time. Earlier warnings of a potentially weakened
condition may be evidenced by depressed metabolic reserve, as evidenced by an
overly depressed pH level as a function of activity level. Therefore, some
embodiments include an electrotherapy device that incorporates one or more motion
sensors. In these embodiments, the electrotherapy device may calculate an activity
level and then the pH and other metabolic measures such as mitochondrial respiration
can be correlative to the activity level. In this way, metabolic reserve can be roughly
estimated, by the electrotherapy device, as the ration of the metabolic state divided by
the activity level. In addition, in some embodiments, the electrotherapy device
calculates a baseline metabolic reserve for each patient at the time they are fitted with
the electrotherapy device. If during the course of use, the electrotherapy device
determines that the metabolic reserve has significantly degraded then further action
may be taken by the electrotherapy device. Examples of further action that may be
taken include issuing a warning to the patient, sending a communication via cell or
wireless to the patient's doctor, or even possibly initiating some adjunctive electrical
therapy like packet pacing.
Patients with diabetes may also be further at risk of syncopal episodes due to
reduced blood glucose levels. Therefore, some embodiments of the electrotherapy
device measure blood glucose levels to provide early warning to the patient of this
potentially dangerous condition so that they can take the necessary steps of
prevention.
Multiple motion sensors may be incorporated into some embodiments
including the electrotherapy device in such a way that a complete three dimensional
model is created of the patient's torso, and also, in some examples, of the limbs and
head. By monitoring the three-dimensional motion of the body, earlier symptoms of
balance loss can be detected by these embodiments in advance of the full syncopal
episode. Subtle changes such as disregulation of verticality (swaying of the body) can
be detected prior to a patient's loss of consciousness.
Some embodiments include an electrotherapy device that comprises
stimulating electrodes located proximate to regions of the patient' s body that are
designed to primarily stimulate the nervous system, rather than the myocardium. For
instance, in one embodiment, electrodes may be placed on the neck in locations such
that, when activated, cause stimulation current to flow across the superior cervical
ganglia. The electrodes may vary in size and shape. In one embodiment, the
electrode is an elongated strip l"x3" in length, configured in a butterfly configuration,
with the anode and cathode at opposite ends of the strip. The strip is positioned with
the vertical axis of the cervical ganglion centered between the two stimulating
electrodes. The electrodes are placed during fitting of the device. The electrotherapy
device may conduct a test to determine if the electrodes are positioned to stimulate
primarily the cervical ganglion or other sympathetic nervous system nerve (as
opposed to vagal) and the electrodes may be repositioned if this is not the case.
In some embodiments, if any of the above-mentioned conditions are
encountered, then the electrotherapy device may apply varying degrees of stimulation
to the nerves. Initially, the stimulation may be at a relatively low level, so as not to
cause discomfort, surprise or panic in the patient.
In other embodiments, the electrotherapy device may include an additional set
of electrodes placed to stimulate primarily vagal nerves.
In other embodiments, the wearable defibrillator transmits recorded data to a
remote server via a network interface, such as the network interface 106 described
below with reference to FIG. 1. In these embodiments, a large volume of recorded
data is accumulated on the remote server over a prolonged period of time (e.g., weeks
or months). This large volume of data may be analyzed using a variety of techniques
to extract knowledge regarding the root cause or causes of a patient's symptoms. The
analysis techniques used to mine this data may include correlation analysis, data
variable comparisons, sandbox playing, discovery processes, iterative testing, looking
for relations, subtraction, injection, and timeline matchup. In other embodiments, the
data is recorded on removable data storage, such as an SD card, which may be
removed from the device. This embodiment may be especially well suited for
collecting and providing large volumes of recorded data.
In other embodiments, the wearable defibrillator is configured to use the
catalogue of predetermined patterns to analyze the recorded data and identify
predetermined patterns within the data that are associated with syncope or other
symptoms. In these embodiments, the wearable defibrillator is configured to, after
identifying one or more predetermined patterns associated with a symptom, perform
intervening actions to address the symptom.
In another embodiment, the wearable defibrillator is configured in accord with
the wearable defibrillator described in co-pending Application Serial No. 13/109,382,
entitled "WEARABLE AMBULATORY MEDICAL DEVICE WITH MULTIPLE
SENSING ELECTRODES," filed May 17, 201 1, which is hereby incorporated herein
by reference in its entirety. In other embodiments, a control unit of the wearable
defibrillator includes a set of components configured to perform the processes
described herein. This set of components may include hardware components or a
combination of hardware and software components.
The examples of the methods and apparatuses discussed herein are not limited
in application to the details of construction and the arrangement of components set
forth in the following description or illustrated in the accompanying drawings. The
methods and apparatuses are capable of implementation in other examples and of
being practiced or of being carried out in various ways. Examples of specific
implementations are provided herein for illustrative purposes only and are not
intended to be limiting. In particular, acts, elements and features discussed in
connection with any one or more examples are not intended to be excluded from a
similar role in any other examples.
Also, the phraseology and terminology used herein is for the purpose of
description and should not be regarded as limiting. Any references to examples or
elements or acts of the systems and methods herein referred to in the singular may
also embrace examples including a plurality of these elements, and any references in
plural to any example or element or act herein may also embrace examples including
only a single element. References in the singular or plural form are not intended to
limit the presently disclosed systems or methods, their components, acts, or elements.
The use herein of "including," "comprising," "having," "containing," "involving,"
and variations thereof is meant to encompass the items listed thereafter and
equivalents thereof as well as additional items. 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.
Wearable Medical Device Controller
FIG. 1 illustrates a wearable medical device controller 100 that is configured
to monitor a patient and the patient' s environment for events of interest, to record
these events, and to intervene, where appropriate, by treating the patient or issuing a
notification to an external entity, such a person (e.g., patients, physicians, and
monitoring personnel) or another computer system (e.g., monitoring systems or
emergency response systems). As shown in FIG. 1, the wearable medical device
controller 100 includes a processor 118, a sensor interface 112, an event manager 114,
a therapy delivery interface 102, data storage 104, a communication network interface
106, a user interface 108 and a battery 110. The data storage 104 includes event
profile information 116 and other event information. In some embodiments, the data
storage 104 includes sufficient capacity to store 2 or more weeks of physiological
information. In other embodiments, the data storage 104 may be removable. Further,
in this illustrated example, the battery 110 is a rechargeable 3 cell 2200mAh lithium
ion battery pack that provides electrical power to the other device components with a
minimum 24 hour runtime between charges.
According to the example illustrated in FIG. 1, the processor 118 is coupled to
the sensor interface 112, the therapy delivery interface 102, the data storage 104, the
network interface 106 and the user interface 108. The processor 118 performs a series
of instructions that result in manipulated data which is stored in and retrieved from the
data storage 104. According to a variety of examples, the processor 118 is a
commercially available processor such as a processor manufactured by Texas
Instruments, Intel, AMD, Sun, IBM, Motorola, Freescale and ARM Holdings.
However, the processor 118 may be any type of processor, multiprocessor or
controller, whether commercially available or specially manufactured. For instance,
according to one example, the processor 118 may include a power conserving
processor arrangement such as described in co-pending Application Serial No.
12/833,096, entitled "SYSTEM AND METHOD FOR CONSERVING POWER IN A
MEDICAL DEVICE," filed July 9, 2010 (hereinafter the "Ό 96 application"), which
is hereby incorporated herein by reference in its entirety. In another example, the
processor 118 is an Intel® PXA270.
In addition, in several examples the processor 118 is configured to execute a
conventional real-time operating system ("RTOS"), such as RTLinux. In these
examples, the RTOS may provide platform services for application software, such as
some examples of the event manager 114, which is discussed further below. These
platform services may include inter-process and network communication, file system
management and standard database manipulation. However, one of many operating
systems may be used, and examples are not limited to any particular operating system
or operating system characteristic. For instance, in some examples, the general
purpose processor 102 may be configured to execute a non real time operating system,
such as BSD or GNU/Linux.
The event manager 114 is configured to manage event profiles, such as event
profiles specified in the event profile information 116, to detect events according to
predetermined patterns and comparison rules included in the event profiles, and to
process events according to logic included in the event profile. The event profiles
may specify that events be identified based on a variety of predetermined patterns of
data including data representative of the patient's physical condition and data
representative of the patient' s behavior.
For example, one or more event profiles may specify that the event manager
114 record an event after receiving an indication that an external entity, such as a
patient, has interacted with the user interface 108 in one or more predetermined ways
(e.g., the user presses a particular response button). For instance, according to one
embodiment, the user interface 108 includes a response button designated to record a
syncopal event. In this embodiment, an event profile specifies that the event manager
114 record a syncopal event after receiving an indication that an external entity has
pressed the syncope response button. According to one exemplary usage scenario, a
patient may press the syncope response button when encountering a prodrome
associated with syncope, such as lightheadedness or dizziness. Other user-identified
events configured to record data representative of other symptoms or disorders may
be recorded in this manner. In recording the events, the event manager 114 may store
records of the events in the data storage 104. Such recordings may provide valuable
evidence of clinically significant events that may otherwise be missed.
In another example, an event profile specifies that the event manager 114
record an event after identifying a predetermined pattern for tachycardia, which is an
abnormally fast heart rhythm, within data received via the sensor interface 112.
According to this example, the event profile further specifies that the event manager
114 initiate a treatment protocol that may result in a defibrillation shock of
approximately 150 Joules being administered to the patient via the therapy delivery
interface 102 to treat the tachycardia.
In another example, an event profile specifies that the event manager 114
record an event after identifying a predetermined pattern for ventricular fibrillation,
which is a severely abnormal heart rhythm, within data received via the sensor
interface 112. According to this example, the event profile further specifies that the
event manager 114 initiate a treatment protocol that may result in a defibrillation
shock being administered to the patient via the therapy delivery interface 102 to treat
the ventricular fibrillation.
In another example, an event profile specifies that the event manager 114
record an event after identifying a predetermined pattern for bradycardia, which is an
abnormally slow heart rhythm, within data received via the sensor interface 112.
According to this example, the event profile further specifies that the event manager
114 initiate a treatment protocol that may result in a therapeutic treatment being
administered to the patient via the therapy delivery interface 102 to treat the
bradycardia. Examples of this therapeutic treatment include a pacing pulse and a
defibrillation shock.
In another example, an event profile specifies that the event manager 114
record an event after identifying a predetermined pattern for a precursor of syncope
within data received via the sensor interface 112. This predetermined pattern may be
indicative of any combination of a number of physical phenomena such as central
nervous system ischemia, low blood pressure, hypoglycemia, a vasovagal response,
an abnormal heart rate, an abnormal variability in heart rate, a cardiac arrhythmia
(e.g., tachycardia or bradycardia, among others), a pulmonary embolism, a change in
the patient's gait, increased swaying when the patient walks, excessive coughing by
the patient, increased sweating by the patient. According to this example, the event
profile further specifies that the event manager 114 notify an external entity that an
episode of syncope may be imminent. Examples of the types of notifications that the
event manager 114 may initiate are described in co-pending Application Serial No.
13/428,703, entitled "SYSTEM AND METHOD FOR ADAPTING ALARMS IN A
WEARABLE MEDICAL DEVICE," filed March 23, 2012, which is hereby
incorporated herein by reference in its entirety. The external entities notified may
include the patient, the patient's physician, or the patient's caregiver and the
notification may include prompts instructing the external entity to take a particular
course of action. In one example, the notification prompts the patient to sit down or
call of help, thereby preventing a potential fall. According to another example, a
notification is issued to a patient to prevent a syncope episode. In this example, the
notification is designed to cause a physiological response, such as a startle response,
in the patient that averts the syncope episode.
In another example, an event profile specifies that the event manager 114
record an event after identifying a predetermined pattern for stroke within data
received via the sensor interface 112. According to this example, the event profile
further specifies that the event manager 114 initiate a testing protocol via the user
interface 108 that presents the patient with an on-screen questionnaire configured to
determine whether the patient has suffered a stroke. The testing protocol may further
include a reaction time measurement to further aid in determining whether a stroke
event has occurred.
It is to be appreciated that any event profile may further specify that the event
manager 114 initiate a responsiveness test. According to one exemplary
responsiveness test, the event manager 114 issues a notification lasting a
predetermined period of time, (e.g., at least 25 seconds) and awaits a target response.
This target response may include actuation of one or more response buttons that are a
part of the wearable defibrillator. Further, according to this example, if the target
response is received, but the response buttons do not remain actuated (perhaps
signaling that the patient has lost consciousness), the event manager 114 reissues the
notification. The notification includes audible tones that escalate in volume, followed
by voice warnings to bystanders indicating that a therapeutic shock is imminent.
After completing the notification, the event manger 114 may initiate a treatment
protocol, which may result in a therapeutic shock or which may be aborted where an
abnormality resolves or another patient response is received prior to delivery of the
therapeutic shock.
The event manager 114 may be implemented using hardware or a combination
of hardware and software. For instance, in one embodiment, the event manager 114 is
implemented as a software component that is stored within the data storage 104 and
executed by the processor 118. In this example, the instructions included in the event
manager 114 program the processor 118 to configure event profiles and detect events
using the event profiles. In other examples, event manager 114 may be an
application- specific integrated circuit ("ASIC") that is coupled to the processor 118
and tailored to manage event profiles and detect events using events specified within
the event profiles. Thus, embodiments of the event manager 114 are not limited to a
particular hardware or software implementation. Specific examples of the processes
performed by the event manager 114 are discussed further below with reference to
FIGS. 3 and 4.
In some embodiments, the components disclosed herein, such as the event
manager 114, may read parameters that affect the functions performed by the
components. These parameters may be physically stored in any form of suitable
memory including volatile memory, such as RAM, or nonvolatile memory, such as a
magnetic hard drive. In addition, the parameters may be logically stored in a
propriety data structure, such as a database or file defined by a user mode application,
or in a commonly shared data structure, such as an application registry that is defined
by an operating system. In addition, some embodiments provide for both system and
user interfaces, as may be implemented using the user interface 108, that allow
external entities to modify the parameters and thereby configure the behavior of the
components.
For example, the event manager 114 includes a disorder mode parameter. The
disorder mode parameter indicates a generalized set of preferences that the event
manager 114 applies to determine if an event as occurred. In one embodiment, each
disorder mode is associated one or more event profiles and the event manager 114
utilizes the current disorder mode to resolve which event profiles are active and which
are inactive. In this embodiment, inbound, unprocessed data is compared against the
active profiles to determine if an event has occurred. Example disorder modes
include, but are not limited to, arrhythmia (the event manager 114 detects cardiac
arrhythmias), syncope (the event manager 114 detects syncope), stroke (the event
manager detects stroke) and hybrid (the event manager 114 detects any combination
of the previous disorders and symptoms).
The data storage 104 includes a computer readable and writeable nonvolatile
data storage medium configured to store non-transitory instructions and other data. In
addition, the data storage 104 includes a processor memory that stores data during
operation of the processor 118. In some examples, the processor memory includes a
relatively high performance, volatile, random access memory such as dynamic
random access memory ("DRAM"), static memory ("SRAM") or synchronous
DRAM. However, the processor memory may include any device for storing data,
such as a non-volatile memory, with sufficient throughput and storage capacity to
support the functions described herein. According to several examples, the processor
118 causes data to be read from the nonvolatile data storage medium into the
processor memory prior to processing the data. In these examples, the processor 118
copies the data from the processor memory to the non-volatile storage medium after
processing is complete. A variety of components may manage data movement
between the non-volatile storage medium and the processor memory and examples are
not limited to particular data management components. Further, examples are not
limited to a particular memory, memory system or data storage system.
The instructions stored on the data storage 104 may include executable
programs or other code that can be executed by the processor 118. The data storage
104 also may include information that is recorded, on or in, the medium, and this
information may be processed by the processor 118 during execution of instructions.
More specifically, the information may be stored in one or more data structures
specifically configured to conserve storage space or increase data exchange
performance. The instructions may be persistently stored as encoded signals, and the
instructions may cause the processor 118 to perform the functions described herein.
The medium may, for example, be optical disk, magnetic disk or flash memory,
among others, and may be permanently affixed to, or removable from, the wearable
medical device controller 100.
The event profile information 116 includes data used by the event manager
114 to detect and process events. More particularly, according to the illustrated
embodiment, the event profile information 116 includes information that defines
patterns of data that are associated with events. Data conforming to these patterns
may be received before, during, or after onset of any symptoms associated with a
disorder. The received data underlying the patterns may include any data processed
by the wearable medical device controller 100. However, in broad terms, data may be
received and processed is descriptive of the patient' s physical condition or behavior.
The data may be received by a wide variety of components and thus descriptive of a
wide variety of physical phenomenon. Examples of some components through which
data may be acquired are described further below with reference to FIG. 2.
Common event characteristics include a pattern of data representative of the
event, one or more symptoms associated with the event, one or more disorder modes
in which the event manager 114 actively scans for and records the event, and one or
more intervention processes to be performed upon detection of the event.
Intervention processes may include diagnostic, reporting, and treatment processes that
are specific to the event. Specific examples of intervention processes are described
further below with reference to FIG. 4.
As illustrated in FIG. 1, the event manager 114 and the event profile
information 116 are separate components. However, in other embodiments, the event
manager 114 and the event profile information 116 are combined into a single
component or re-organized so that a portion of the data included in the event manager
114, such as executable code that causes the processor 118 to adapt a detected event,
resides in the event profile information 118, or vice versa. Such variations in these
and the other components illustrated in FIG. 1 are intended to be within the scope of
the embodiments disclosed herein.
The event profile information 116 may be stored in any logical construction
capable of storing information on a computer readable medium including, among
other structures, flat files, indexed files, hierarchical databases, relational databases or
object oriented databases. In addition, various examples organize the event profile
information 116 into particularized and, in some cases, unique structures to perform
the functions disclosed herein. In these examples, the data structures are sized and
arranged to store values for particular types of data.
As shown in FIG. 1, the wearable medical device controller 100 includes
several system interface components 102, 106 and 112. Each of these system
interface components is configured to exchange (i.e. send or receive) data with one or
more specialized devices that may be located within the wearable medical device
controller 100 or elsewhere. The components used by the interfaces 102, 106 and 112
may include hardware components, software components or a combination of both.
In the instance of each interface, these components physically and logically couple the
wearable medical device controller 100 to the specialized devices. This physical and
logical coupling enables the wearable medical device controller 100 to both
communicate with and, in some instances, control the operation of the specialized
devices. These specialized devices may include physiological sensors, therapy
delivery devices and computer networking devices.
According to various examples, the hardware and software components of the
interfaces 102, 106 and 112 employ a variety of coupling and communication
techniques. In some examples, the interfaces 102, 106 and 112 use leads, cables or
other wired connectors as conduits to exchange data between the wearable medical
device controller 100 and specialized devices. In other examples, the interfaces 102,
106 and 112 communicate with specialized devices using wireless technologies such
as radio frequency or infrared technology. The software components included in the
interfaces 102, 106 and 112 enable the processor 118 to communicate with
specialized devices. These software components may include elements such as
objects, executable code and populated data structures. Together, these software
components provide software interfaces through which the processor 118 can
exchange information with specialized devices. Moreover, in at least some
embodiments where one or more specialized devices communicate using analog
signals, the interfaces 102, 106 and 112 further include components configured to
convert analog information into digital information, and vice-versa, to enable the
processor 118 to communicate with specialized devices.
As discussed above, the system interface components 102, 106 and 112 shown
in the example of FIG. 1 support different types of specialized devices. For instance,
in some embodiments, the components of the sensor interface 112 couple the
processor 118 to one or more physiological sensors such as a body temperature
sensors, respiration monitors, dry capacitive ECG electrodes, adhesive electrodes, or
EEG electrodes. These electrodes may include one or more long term wear electrodes
that are configured to be continuously worn by a patient for extended periods (e.g., 3
or more days). One example of such a long term wear electrode is described in co
pending Application Serial No. 61/653,749, entitled "LONG TERM WEAR
MULTIFUNCTION BIOMEDICAL ELECTRODE," filed 5/31/2012, which is
hereby incorporated herein by reference in its entirety. In other embodiments, the
components of the sensor interface 112 couple the processor 118 to one or more
environmental sensors such as atmospheric thermometers, airflow sensors, audio
sensors, accelerometers, and hygrometers. It is to be appreciated that these sensors
may include sensors with a relatively low sampling rate, such as wireless sensors.
The components of the therapy delivery interface 102 couple one or more
therapy delivery devices, such as capacitors and defibrillator/pacer electrodes, to the
processor 118. In addition, the components of the network interface 106 couple the
processor 118 to a computer network via a networking device, such as a bridge, router
or hub. According to a variety of examples, the network interface 106 supports a
variety of standards and protocols, examples of which include USB (via, for example,
a dongle to a computer), TCP/IP, Ethernet, Wireless Ethernet, Bluetooth, ZigBee, MBus,
CAN-bus, IP, IPV6, UDP, DTN, HTTP, FTP, SNMP, CDMA, NMEA and
GSM. To ensure data transfer is secure, in some examples, the wearable medical
device controller 100 can transmit data via the network interface 106 using a variety
of security measures including, for example, TLS, SSL or VPN. In other examples,
the network interface 106 includes both a physical interface configured for wireless
communication and a physical interface configured for wired communication.
According to various embodiments, the network interface 106 enables communication
between the wearable medical device controller 100 and a variety of personal
electronic devices including computer enabled glasses and earpieces.
Thus, the various system interfaces incorporated in the wearable medical
device controller 100 allow the device to interoperate with a wide variety of devices
in various contexts. For instance, some examples of the wearable medical device
controller 100 are configured to perform a process of sending critical events and data
to a centralized server via the network interface 106. An illustration of a process in
accord with these examples is disclosed in U.S. Patent No. 6,681,003, entitled
"DATA COLLECTION AND SYSTEM MANAGEMENT FOR PATIENT-WORN
MEDICAL DEVICES" and issued on January 20, 2004 which is hereby incorporated
herein by reference in its entirety.
The user interface 108 shown in FIG. 1 includes a combination of hardware
and software components that allow the wearable medical device controller 100 to
communicate with an external entity, such as a user. These components are
configured to receive information from actions such as physical movement, verbal
intonation or thought processes. In addition, the components of the user interface 108
can provide information to external entities. Examples of the components that may be
employed within the user interface 108 include keyboards, mouse devices, trackballs,
microphones, electrodes, response buttons, touch screens, printing devices, display
screens and speakers. In some examples, the electrodes include an illuminating
element, such as an LED. In other examples, the printing devices include printers
capable of rendering visual or tactile (Braille) output.
The wearable medical device controller 100 has a variety of potential
applications and is well suited to devices that detect and process a variety of events,
some of which require a predetermined response from the external entity.
Predetermined responses may include any response that is appropriate given the event
being reported. Predetermined responses may include acknowledgment of the event,
entry of information indicating that the event is being addressed and rectification of
the condition that triggered the event.
Examples of devices to which the wearable medical device controller 100 is
well suited include critical care medical devices, such as a wearable external
defibrillator. An example of one such defibrillator is described in the '096 application
with reference to FIG. 3. In at least one example, the wearable defibrillator 300
illustrated in FIG. 3 of the Ό 96 application employs the wearable medical device
controller 100, as disclosed in the present application, as a substitute for the portable
treatment controller 200 described in the Ό 96 application. In this example, the ECG
Electrodes and Therapy Pads illustrated in FIG. 3 of the Ό 96 application are logically
and physically coupled to the wearable medical device controller 100 via the sensor
interface 112 and the therapy delivery interface 102, respectively.
FIG. 2 illustrates an embodiment which utilizes the wearable medical device
controller 100. As shown in FIG. 2, a wearable defibrillator 200 includes a wearable
device controller 100, one or more ECG sensors 202, one or more EEG sensors 204,
one or more audio sensors 206, one or more motion sensors 208, one or more optical
sensors 212, and one or more treatment electrodes 210. In this embodiment, the
wearable device controller 100 is logically and physically coupled to the treatment
electrodes 210 via the therapy delivery interface 102. Further, in this embodiment,
the wearable device controller 100 is logically and physically coupled to the ECG
sensors 202, the EEG sensors 204, the audio sensors 206, the motion sensors 208, and
the optical sensors via the sensor interface 112.
In some embodiments, the treatment electrodes 210 include a first therapy
electrode and the second therapy electrode that are disposed on the front of a patient's
torso. For example, the first therapy electrode may be externally located at the apex
of the heart and the second therapy electrode may be located along the parasternal
line. In other embodiments, the first therapy electrode is disposed on the front of the
patient's torso and a second therapy electrode is disposed on the back of the patient's
torso. Thus embodiments are not limited to a particular arrangement of treatment
electrodes 210.
In some embodiments, the ECG sensors 202 include ECG Electrodes as
described in association with FIG. 3 of the '096 application. Further, in these
embodiments, the audio sensors 206 includes a microphone or an accelerometer, and
the motion sensors 208 includes an accelerometer. In other embodiments, the
treatment electrodes 210 include Therapy Pads as described in association with FIG. 3
of the '096 application. Using these components, the wearable defibrillator 200 may
collect, store and analyze data descriptive of a wide variety of physical phenomena
such as body impedance (from the ECG sensors 202 or EEG sensors 204), heart
sounds and respiratory function (from the audio sensors 206), and patient activity
(from the motion sensors 208).
The data collected by the wearable defibrillator 200 may be used to analyze
the patient' s physiology and behavior. Measurements of body impedance may be
used to determine if a patient is sweating. Processing of audio signals may be used to
determine if the patient is coughing or if the patient has suffered a pulmonary
embolism. Processing of motion data may be used to determine if there has been a
change in the patient's gait or an increase in swaying while walking.
For instance, from an accelerometer signal received from the motion sensors
208, the wearable medical device controller 100 may calculate velocity by integrating
the acceleration signal. In some embodiments, the motion sensors 208 include
multiple accelerometers, or other types of motion sensors such as magnetic based
velocity sensing or solid state gyroscopes. These motion sensors 208 may be
positioned on various locations of the patient's body such as the shoulder, waist and
arms, as the motion of the patient's body will likely vary at each location on the body.
Further, the motion sensors 208 may communicate wirelessly with the wearable
medical device controller 100 so that the motion sensors 208 can be worn as patches
on these various locations. Using the motion sensors 208, the wearable medical
device controller 100 can determine the patient's body position and orientation, for
instance, whether the patient is standing, sitting, walking or lying down in a prone,
supine or on her side.
In some embodiments, the wearable medical device controller 100 is
configured to predict impending syncope (i.e., identify a precursor of syncope) by
detecting a level of dyskinesia in the patient' s motion and comparing the detected
level to a baseline dyskinesia for the patient. Where a predefined relationship
between the detected dyskinesia and the baseline dyskinesia exists (e.g., detected
dyskinesia exceeds baseline dyskinesia by a threshold value), the wearable medical
device controller 100 identifies the detected dyskinesia as a precursor event and
proceeds accordingly.
For example, in one embodiment configured to identify a precursor of syncope
by estimating a level of dyskinesia in a patient' s motion, the wearable medical device
controller 100 can, based on the patient's body orientation, compare the relative
motions of the motion sensors 208 to determine that a patient is swaying in a way that
resembles an increased sense of imbalance. For instance, the wearable medical device
controller 100 may use motion sensors 208 positioned at the top, middle and lower
regions of the patient's torso to estimate swaying of the spine that is also a sign of
imbalance. Examples of relative motions of the motion sensors 208 that may be
indicative of swaying include increased circular motions that are out of phase between
the shoulders and hips, or of increased shaking of higher frequency components in the
motion in the region of the knees or ankles, which are areas of balance compensation.
In another embodiment configured to identify a precursor of syncope by
estimating a level of dyskinesia in a patient's motion, the wearable medical device
controller 100 categorizes gestural motions to characterize the patient behavior, for
instance as bending over from a standing position or sitting. In this embodiment, the
motion sensors 208 may be worn on the wrist or wrists to determine hand location
relative to other portions of the patient's body. For instance, if the patient bends over
to pick something up, the wearable medical device controller 100 may, based on
gestural motion and relative hand location, categorize the motion as "picking
something up." If, however, the patient bends over, but the relative hand location is
onto the patient's knee (as indicated by a wrist sensor or other motion sensor 208
disposed in a location to detect arm position), then the wearable medical device
controller 100 may categorize the motion as one associated with increased imbalance
and dizziness and as a sign of possible impending syncope.
Wearable optical sensors 212 may also be included to enable the wearable
medical device controller 100 to create a three dimensional representation of the
environment of the patient. For example, in one embodiment the wearable medical
device controller 100 controls relative focusing of stereoscopic cameras included
within the optical sensors 212. In this embodiment, the wearable medical device
controller 100 processes the images provided by the stereoscopic cameras to detect
and define various objects in the field of view. The wearable medical device
controller 100 may further calculate the distance between the patient and the various
objects to create a representation of the space in which the patient is situated (e.g., on
the floor, leaning against a wall, etc.).
Exemplary Event Processes
Various embodiments implement and enable processes through which a
wearable defibrillator, such as the wearable defibrillator 200, protects a patient from
treatable cardiac disorders while monitoring and detecting for causes of other
symptoms, such as syncope. FIG. 3 illustrates one such process 300 that includes acts
of identifying a patient with syncope, fitting a patient with a wearable defibrillator,
and collecting and analyzing patient data. The process 300 begins at 302.
In act 304, a health care professional, such as a physician, evaluates a patient who
presents with symptoms indicative of syncope. For instance, according to one
example, a patient presents at a hospital emergency department with syncope.
More specifically, in some examples, the health care professional may
diagnose a patient as having experienced cardiac syncope or undiagnosed syncope
(e.g., a syncopal event with an unknown source, which may or may not be cardiac).
In these examples, patients are diagnosed based on one or more of the following
criteria: a history, or family history, of cardiovascular disease (e.g. coronary artery
disease, heart failure, structural heart disease); abnormal ECG findings (e.g. ischemia,
dysrhythmias, conduction abnormalities); advanced age; and low hematocrit count.
Based on these, or other, criteria the health care professional identifies a syncopal
event within the patient' s history.
In act 306, the patient is fitted with a wearable defibrillator, such as the
wearable defibrillator 200 described above with reference to FIG. 2, in response to
identification of the syncopal event,. For instance, continuing the previous example,
the patient of the emergency department is outfitted with the wearable defibrillator
and sent home for monitoring. In an alternative example, the patient remains in the
hospital for observation.
In some embodiments, components of the wearable defibrillator are housed
within a garment. In these embodiments, the act 306 includes adjusting the garment
to promote contact between the surface of the patient's skin and the electrodes
included with the wearable defibrillator. In other embodiments, the wearable
defibrillator includes adhesive electrodes. In these embodiments, the act 306 includes
applying the adhesive electrodes to the surface of the patient's skin. It is to be
appreciated that embodiments including adhesive electrodes may alter or reduce the
skill required to fit the patient and may translate well to the pre-existing skill set of
particular personnel, such as emergency department personnel.
In act 308, the wearable defibrillator 200 collects and analyzes patient data.
Actions performed by the wearable defibrillator 200 during execution of the act 308
are described further below with reference to FIG. 4.
Process 300 ends at 310. Embodiments in accord with process 300 assist a
medical professional in diagnosing syncope and identifying its root cause or causes
while continuously monitoring the patient and automatically treating cardiac
arrhythmias that may occur.
It is to be appreciated that the method 300 may include acts of expressly
excluding (e.g. not fitting with a wearable defibrillator) a patient presenting with
syncope who has been definitively diagnosed as having experienced non-cardiac
syncope, including but not limited to patients having suffered one of the following:
vasovagal syncope, orthostatic syncope, carotid sinus syncope, drug-related syncope,
and seizure.
Further, it is to be appreciated that the data collected by the wearable
defibrillator 200 may allow a medical professional to eliminate potential root causes
for syncope in a given patient. For instance, while it is often the case that syncope is
caused by disorders involving the cardiovascular system, some patients experience
syncopal episodes that are caused by a disorder outside of the cardiovascular system.
In these situations, the wearable defibrillator 200 may not be able to prevent a
syncopal episode or treat its underlying cause, but by recording physiological data
before, during, and after a patient experiences the syncopal episode, the wearable
defibrillator 200 may provide the medical professional with information that indicates
the root cause of the syncope is not within the cardiovascular system (e.g.,
information that indicates normal cardiac function before, during, and after the
syncopal episode).
As discussed above with regard to act 308 illustrated in FIG. 3, various
embodiments implement processes for collecting and analyzing patient data while
protecting the patient from one or more treatable cardiac disorders. FIG. 4 illustrates
one such process 400 that implements act 308 and that includes acts of detecting an
event, recording the event, determining if the event is addressable and addressing the
event. In one embodiment, a wearable defibrillator executes the process 400
beginning at 402.
In act 404, an event manager, such as the event manager 114 described above
with reference to FIG. 1, detects an event. In some embodiments, when executing the
act 404, the event manager first determines which events are active under the
currently selected disorder mode. Next, the event manager scans inbound data and
identifies any patterns in the data that match a predetermined pattern specified in an
active event profile. Events that may be detected by execution of the act 404 include
any of the events described herein, such as cardiac arrhythmias, syncope precursors,
and user-initiated events.
In act 406, the event manager records the event by storing information
descriptive of the event in data storage. This event information may include
information descriptive of the type of event, the timing of the event, ECG (or other)
signals associated with the event, notifications and responses associated with the
event, treatment protocols initiated as a result of the event, the amount of energy
delivered during the treatment protocols and the amount of transthoracic impedance
encountered measured during the event. In act 408, the event manager determines
whether the event is addressable by determining whether the event profile
corresponding to the event includes an association with processing logic to be
executed after detection of the event. If the event is addressable, the event manager
intervenes by executing the processing logic associated with the event in act 410. The
intervening actions taken by the wearable defibrillator may include any of the
intervening actions described herein, such as pacing a patient's heart, issuing a
defibrillation shock, or issuing a notification to an external entity. If the event is not
addressable, the event manager proceeds to act 412. In the act 412, the event manager
terminates the process 400.
It is to be appreciated that, in some instances, addressing an event by issuing a
notification to a patient may have a therapeutic effect (i.e., the notification itself may
be a therapeutic treatment). For example, where onset of a syncopal episode is
imminent, the issuance of an alarm may cause a physiological response in the patient,
such as an adrenaline surge, that averts the syncopal episode.
Examples in accord with process 400 enable a wearable defibrillator to gather,
record, and report patient information for use in diagnosing disorders that have many
potential causes and that manifest many potential symptoms, such as syncope. By
wearing a device over an indefinite period of time, and allowing the patient to return
to normal activities, data can be acquired about the patient that can lead to a definitive
diagnosis. In addition, because the information is gathered by a wearable
defibrillator, the patient is protected against possibly life-threatening cardiac
arrhythmias.
Each of the processes disclosed herein depicts one particular sequence of acts
in a particular example. The acts included in each of these processes may be
performed by, or using, a wearable defibrillator specially configured as discussed
herein. Some acts are optional and, as such, may be omitted in accord with one or
more examples. Additionally, the order of acts can be altered, or other acts can be
added, without departing from the scope of the systems and methods discussed herein.
In addition, as discussed above, in at least one example, the acts are performed on a
particular, specially configured machine, namely a wearable defibrillator configured
according to the examples disclosed herein.
Having thus described several aspects of at least one embodiment, it is to be
appreciated various alterations, modifications, and improvements will readily occur to
those skilled in the art. Such alterations, modifications, and improvements are
intended to be part of this disclosure, and are intended to be within the scope of the
invention. Accordingly, the foregoing description and drawings are by way of
example only.
What is claimed is:

CLAIMS
1. A method of treating a patient presenting with syncope, the method comprising:
detecting, by a wearable defibrillator, an event associated with syncope;
storing, by the wearable defibrillator, data descriptive of the event in
association with an indication that the data includes data descriptive of a syncopal
event; and
addressing the event.
2. The method according to claim 1, wherein detecting the event includes detecting a
cardiac arrhythmia.
3. The method according to claim 2, wherein detecting the cardiac arrhythmia
includes detecting at least one of ventricular tachycardia, ventricular fibrillation, and
bradycardia and addressing the event includes issuing a therapeutic treatment.
4. The method according to claim 3, wherein issuing the therapeutic treatment
includes issuing at least one of a pacing pulse and a defibrillation shock.
5. The method according to claim 1, wherein addressing the event includes issuing a
notification to an external entity.
6. The method according to claim 1, wherein detecting the event includes identifying
a pattern of data including data received from a plurality of sensors.
7. The method according to claim 6, wherein identifying the pattern of data includes
identifying a pattern of data that includes data received from at least one of an
electrocardiogram sensor, a motion sensor, and an optical sensor.
8. The method according to claim 7, wherein identifying the pattern of data includes
identifying a pattern of data indicative of a level of dyskinesia.
9. The method according to claim 8, wherein identifying the pattern of data includes
identifying a pattern of data indicative of a location of a patient within a space.
10. A wearable medical device capable of treating a patient presenting with syncope,
the wearable medical device comprising:
a memory storing event profile information;
a battery;
at least one treatment electrode coupled to the battery;
at least one processor coupled to the memory and the at least one treatment
electrode; and
an event manager executed by the at least one processor and configured to:
detect an event associated with syncope;
store, in the memory, data descriptive of the event in association with
an indication that the data includes data descriptive of a syncopal event; and
address the event.
11. The device according to claim 10, wherein the event includes a cardiac
arrhythmia.
12. The device according to claim 11, wherein the cardiac arrhythmia is at least one
of ventricular tachycardia, ventricular fibrillation, and bradycardia and the event
manager is configured to address the event by issuing a therapeutic treatment.
13. The device according to claim 12, wherein the event manager is configured to
issue the therapeutic treatment by issuing at least one of a pacing pulse and a
defibrillation shock.
14. The device according to claim 10, wherein the event manager is configured to
address the event by issuing a notification to an external entity.
15. The device according to claim 10, wherein the event manager is configured to
detect the event by identifying a pattern of data including data received from a
plurality of sensors.
16. The device according to claim 15, wherein the event manager is configured to
identify the pattern of data by identifying a pattern of data that includes data received
from at least one of an electrocardiogram sensor and a motion sensor.
17. The device according to claim 16, wherein the event profile information includes
information descriptive of the pattern of data.
18. The method according to claim 17, wherein the pattern of data includes a pattern
of data indicative of a level of dyskinesia.
19. The method according to claim 18, wherein the pattern of data includes a pattern
of data indicative of a location of a patient within a space.
20. A method for protecting a patient presenting with syncope from cardiac
dysfunction, the method comprising:
identifying a syncopal event within the patient' s history; and
providing, responsive to identifying the syncopal event, the patient with a
wearable defibrillator.
21. The method according to claim 20, further comprising monitoring the patient's
physiology via the wearable defibrillator.
22. The method according to claim 21, further comprising contacting the patient
where monitoring reveals the presence of an arrhythmia.
23. The method according to claim 22, wherein the act of providing the patient with
the wearable defibrillator is responsive to a diagnosis of at least one of cardiac
dysfunction and undiagnosed syncope.
24. The method according to claim 20, wherein the act of providing the patient with
the wearable defibrillator includes providing the patient with a wearable defibrillator
configured to identify and treat cardiac dysfunction.
25. The method according to claim 20, wherein the act of providing the patient with
the wearable defibrillator includes an act of providing the patient with a wearable
defibrillator that includes a long term wear electrode.