CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional
Application Serial No. 61/840,787 titled "SYSTEMS AND METHODS OF
DELIVERING THERAPY USING AN AMBULATORY MEDICAL DEVICE,"
filed June 28, 2013, which is incorporated herein by reference in its entirety.
BACKGROUND
Technical Field
[0002] Aspects of the present invention relate to medical devices, and more
particularly to apparatus and processes of delivering therapy using an ambulatory
medical device.
Discussion
[0003] Some ambulatory medical devices deliver therapy to patients. For instance, an
ambulatory medical device may monitor a patient' s electrocardiogram (ECG) signal
for indications of a cardiac abnormality. Where the ambulatory medical device
identifies a cardiac abnormality that is treatable via the administration of a therapeutic
shock, the ambulatory medical device may initiate a treatment protocol. When
executing a treatment protocol, the ambulatory medical device must determine, with a
high degree of accuracy, when it is appropriate to deliver therapy to the patient. The
patient may, however, have the need to delay the administration of the therapy due to
conditions that the ambulatory medical device is not configured to detect.
SUMMARY
[0004] In accordance with at least one aspect of the embodiments disclosed herein, an
ambulatory medical device is provided. The ambulatory medical device accurately
determines whether a patient requires a delay or prevention of the administration of
therapy. In making this determination, the ambulatory medical device executes a
process that is sensitive to and identifies potential false positives. For example, in
some embodiments, the ambulatory medical device is configured to identify a state of
responsiveness of the patient (e.g., a patient condition). Also, in some embodiments,
the ambulatory medical device is configured to enable patients with poor dexterity or
poor fine motor skills (including, but not limited to, patients with arthritis and
diabetes) to engage a delay of treatment through one or more response mechanisms.
The ambulatory medical device and the processes executed thereby may include
audible and visual stimuli to a patient requesting the patient perform one or more
specific actions within a predetermined amount of time to delay or prevent the
administration of therapy.
[0005] According to an aspect, an ambulatory medical device capable of delivering
therapy to a patient is provided. The ambulatory medical device comprises at least one
sensor configured to detect a health disorder of the patient, at least one treatment
element configured to deliver therapy to the patient, at least one response mechanism
configured to be actuated by the patient, the at least one response mechanism having
one of a first state and a second state, and at least one controller operatively connected
to the at least one sensor, the at least one treatment element, and the at least one
response mechanism. The at least one controller being configured to delay delivery of
the therapy to patient for a first predetermined period of time responsive to detection
of the health disorder and the at least one response mechanism having the first state,
and to deliver the therapy to the patient in response to continued detection of the
health disorder, the at least one response mechanism remaining in the first state, and a
lack of responsiveness by the patient following expiration of the predetermined period
of time.
[0006] According to an aspect, an ambulatory medical device capable of delivering
therapy to a patient is provided. The ambulatory medical device comprises at least
one response mechanism, the at least one response mechanism having a state that is
one of a first state and a second state, a controller coupled with the at least one
response mechanism, the controller including at least one processor coupled with a
memory, and a therapy management component. The therapy management
component being executable by the controller and configured to detect at least one
physiological parameter having at least one value indicative of a health disorder of the
patient, request the patient change the state of the at least one response mechanism
from the first state to the second state in response to the detection of the at least one
physiological parameter, monitor the state of the at least one response mechanism
within a first predetermined period of time, delay administration of therapy to the
patient in response to detection of a change in the state of the at least one response
mechanism from the first state to the second state within the first predetermined
period of time, monitor the state of the of the at least one response mechanism for a
second predetermined period of time, request the patient change the state of the at
least one response mechanism from the second state to the first state in response to
detection of the state of the at least one response mechanism remaining in the second
state for the second predetermined period of time, and one of further delay the
administration of therapy in response to detection of a change in the state of the at
least one response mechanism from the second state to the first state, and prepare to
deliver the therapy to the patient in response to the state of the at least one response
mechanism not changing from the second state to the first state following expiration
of the second period of time.
[0007] According to an embodiment, the ambulatory medical device further
comprises at least one therapy pad coupled with the controller, and at least one ECG
sensor coupled with the controller. According to an embodiment, the ambulatory
medical device is further configured to deliver at least one defibrillating shock to the
patient via the at least one therapy pad and the therapy management component is
configured to delay the administration of therapy to the patient by delaying the
administration of the at least one defibrillating shock. According to an embodiment,
the therapy management component is further configured to detect the at least one
physiological parameter by monitoring a cardiac rhythm of the patient via the at least
one ECG sensor. According to an embodiment, the therapy management component
is further configured to detect the at least one physiological parameter having the at
least one value indicative of the health disorder by detecting at least one physiological
parameter having at least one value indicative of at least one of ventricular
tachycardia, ventricular defibrillation, bradycardia, tachycardia, erratic heart rate,
asystole, and pulseless electrical activity. According to an embodiment, the therapy
management component is further configured to further delay the administration of
therapy to the patient by further delaying the administration of therapy for a duration
that is greater for ventricular tachycardia than for ventricular defibrillation.
[0008] According to an embodiment the ambulatory medical device includes a
display coupled with the controller and the therapy management component is further
configured to display, via the display, at least one notification requesting that the
patient change the state of the at least one response mechanism. According to an
embodiment, the therapy management component is further configured to display, via
the display, one or more notifications to the patient indicating a delay in the
administration of therapy to the patient.
[0009] According to an embodiment, the ambulatory medical device includes a
speaker coupled with the controller and the therapy management component is further
configured to request that the patient change the state in response to the detection of
the at least one physiological parameter by generating audible alerts to the patient via
the speaker. According to an embodiment, the therapy management component is
further configured to generate, via the speaker, audible alerts to the patient indicating
a delay in the administration of therapy to the patient.
[0010] According to an embodiment, the therapy management component is further
configured to monitor a state of consciousness of the patient. According to an
embodiment, the ambulatory medical device further includes an accelerometer
coupled with the controller and the therapy management component is configured to
monitor the state of consciousness of the patient by monitoring patient motion.
According to an embodiment, the therapy management component is further
configured to delay the administration of therapy in response to detection of targeted
patient motion. According to an embodiment, the therapy management component is
further configured to administer therapy to the patient in response to detection of a
patient fall.
[0011] According to an embodiment, the ambulatory medical device includes a tactile
stimulator coupled with the controller and the therapy management component is
further configured to request the patient change the state of the at least one response
mechanism by vibrating the ambulatory medical device controller via the tactile
stimulator.
[0012] According to an embodiment, the therapy management component is
configured to delay the administration of therapy to the patient in response to the
detection of a change in the state of the at least one response mechanism from the
second state to the first state within the second period of time by delaying the
administration of therapy an interval of time selected based on a severity of the health
disorder. According to an embodiment, the at least one response mechanism includes
at least one response button. According to an embodiment, the first state of the at
least one response button includes a deactivated state and the second state of the at
least one response button includes an activated state.
[0013] According to an aspect, a method of delivering therapy to a patient using an
ambulatory medical device is provided. The ambulatory medical device includes a
controller coupled with at least one response mechanism, the at least one response
mechanisms having a state that is one of a first state and a second state. The method
comprises detecting, by the ambulatory medical device, at least one physiological
parameter having at least one value indicative of a health disorder of the patient,
requesting the patient change the at least one response mechanism from the first state
to the second state in response to detecting the at least one physiological parameter,
monitoring the state of at least one response mechanism within a first predetermined
period of time, delaying administration of therapy to the patient in response to
detecting a change in the state of the at least one response mechanism from the first
state to the second state within the first predetermined period of time, monitoring the
state of the at least one response mechanism for a second predetermined period of
time, requesting the patient change the state of the at least one response mechanism
from the second state to the first state in response to detecting the state of the at least
one response mechanism remaining in the second state for the second predetermined
period of time, and one of further delaying the administration of therapy in response
to detection of a change in the state of the at least one response mechanism from the
second state to the first state, and preparing to deliver the therapy to the patient in
response to the state of the at least one response mechanism not changing from the
second state to the first state following expiration of the second period of time.
[0014] According to an embodiment, the ambulatory medical device includes at least
one electrocardiogram (ECG) sensor coupled with the controller and detecting, by the
ambulatory medical device, the at least one physiological parameter includes
detecting an ECG signal. According to an embodiment, the ambulatory medical
device is configured to deliver at least one defibrillating shock to the patient via at
least one therapy pad coupled with the controller and delaying the administration of
therapy to the patient includes delaying the delivery of the at least one defibrillating
shock. According to an embodiment, detecting, by the ambulatory medical device,
the at least one physiological parameter includes monitoring a cardiac rhythm of the
patient via the at least one ECG sensor. According to an embodiment, detecting, by
the ambulatory medical device, the at least one physiological parameter having the at
least one value indicative of the health disorder includes detecting at least one
physiological parameter having at least one value indicative of at least one of
ventricular tachycardia, ventricular defibrillation, bradycardia, tachycardia, erratic
heart rate, asystole, and pulseless electrical activity.
[0015] According to an embodiment, the ambulatory medical device includes a
display coupled with the controller and requesting that the patient change the state of
the at least one response mechanism from the first state to the second state includes
displaying at least one notification to the patient via the display. According to an
embodiment, delaying the administration of therapy to the patient in response to
detecting a change in the state of the at least one response mechanism from the first
state to the second state includes displaying one or more notifications to the patient
via the display.
[0016] According to an embodiment, the ambulatory medical device includes a
speaker coupled with the controller and requesting that the patient change the state of
the at least one response mechanism from the first state to the second state includes
generating audible alerts to the patient via the speaker. According to an embodiment,
delaying the administration of therapy to the patient in response to detecting a change
from the first state to the second state includes generating audible alerts to the patient
via the speaker.
[0017] According to an embodiment, the method further includes monitoring a state
of consciousness of the patient. According to an embodiment, the method further
includes delaying the administration of therapy to the patient in response to detecting
a change in the state of the at least one response mechanism from the first state to the
second state within the first predetermined period of time and a conscious patient in
the second predetermined period of time. According to an embodiment, the
ambulatory medical device further includes an accelerometer coupled with the
controller and monitoring the state of consciousness of the patient includes
monitoring patient motion. According to an embodiment, the method further includes
administering therapy to the patient in response to detecting a patient fall.
[0018] According to an embodiment, the ambulatory medical device includes a tactile
stimulator coupled with the controller and requesting that the patient change the state
of the at least one response mechanism from the first state to the second state includes
vibrating the ambulatory medical device controller via the tactile stimulator.
[0019] According to an embodiment, delaying further the administration of therapy to
the patient in response to detecting a change in the state of the at least one response
mechanism from the second state to the first state includes delaying the administration
of therapy for a time interval selected based on a severity of the health disorder.
[0020] According to an aspect, a non-transitory computer readable medium storing
executable instructions configured to instruct at least one controller to perform a
method of delivering therapy is provided. The method comprises detecting, by the
ambulatory medical device, at least one physiological parameter having at least one
value indicative of a health disorder of the patient, requesting the patient change the at
least one response mechanism from the first state to the second state in response to
detecting the at least one physiological parameter, monitoring the state of at least one
response mechanism within a first predetermined period of time, delaying
administration of therapy to the patient in response to detecting a change in the state
of the at least one response mechanism from the first state to the second state within
the first predetermined period of time, monitoring the state of the at least one response
mechanism for a second predetermined period of time, requesting the patient change
the state of the at least one response mechanism from the second state to the first state
in response to detecting the state of the at least one response mechanism remaining in
the second state for the second predetermined period of time, and one of further
delaying the administration of therapy in response to detection of a change in the state
of the at least one response mechanism from the second state to the first state, and
preparing to deliver the therapy to the patient in response to the state of the at least
one response mechanism not changing from the second state to the first state
following expiration of the second period of time.
[0021] According to an aspect, an ambulatory medical device capable of delivering
therapy to the patient and configurable between a plurality of operation modes to
delay administration of therapy is provided. The ambulatory medical device
comprises two or more response mechanisms, each mechanism of the two or more
response mechanisms having a status, a memory storing an active operation mode
parameter identifying which of the plurality of operation modes is active, the plurality
of operation modes including a first operation mode requiring changes in a status of
one of the two or more response mechanisms, and the second operation mode
requiring changes in a status of two of the two or more response mechanisms, a
controller coupled with the two or more response mechanisms, the controller
including at least one processor coupled with the memory, and a therapy management
component. The therapy management component being executable by the controller
and configured to identify the active operation mode from the plurality of operation
modes, detect at least one physiological parameter having at least one value indicative
of a health disorder of the patient, request that the patient change the status of one of
the two or more response mechanisms in response to detection of the at least one
physiological parameter and the identification of the first mode as the active operation
mode, monitor the status of the two or more response mechanisms within a first
predetermined period of time, and delay administration of therapy to the patient in
response to detection of a first change in the status of one of the two or more response
mechanisms within the first predetermined period of time and the identification of the
first mode as the active operation mode.
[0022] According to an embodiment, the therapy management component is further
configured to request, responsive to the detection the first change, that the patient
change the status of one of the two or more response mechanisms, and monitor the
status of the one or more response mechanisms within a second predetermined period
of time, wherein the therapy management component is configured to delay the
administration of therapy by delaying, responsive to the detection of the first change
in the status within the first predetermined period of time and a second change in the
status within the second predetermined period of time, the administration of therapy
to the patient. According to an embodiment, the ambulatory medical device further
comprises at least one therapy pad coupled with the controller, and at least one ECG
sensor coupled with the controller. According to an embodiment, the ambulatory
medical device is configured to deliver at least one defibrillating shock to the patient
via the at least one therapy pad and the therapy management component is configured
to delay in response to the detection of the first change in the status within the first
predetermined period of time the administration of therapy to the patient by delaying
the administration of the at least one defibrillating shock. According to an
embodiment, the therapy management component is configured to detect the at least
one physiological parameter by monitoring a cardiac rhythm of the patient via the at
least one ECG sensor. According to an embodiment, the therapy management
component is configured to detect the at least one physiological parameter having the
at least one value indicative of the health disorder by detecting at least one
physiological parameter having at least one value indicative of at least one of
ventricular tachycardia, ventricular defibrillation, bradycardia, tachycardia, erratic
heart rate, asystole, and pulseless electrical activity.
[0023] According to an embodiment, the therapy management component is
configured to delay the administration of therapy to the patient by delaying the
administration of therapy for a duration that is greater for ventricular tachycardia than
for ventricular defibrillation. According to an embodiment, the ambulatory medical
device includes a display coupled with the controller and the therapy management
component is further configured to display, via the display, at least one notification
requesting that the patient change the status. According to an embodiment, the
therapy management component is further configured to display, via the display, one
or more notifications to the patient indicating a delay in the administration of therapy
to the patient. According to an embodiment, the ambulatory medical device includes
a speaker coupled with the controller and the therapy management component is
configured to request that the patient change the status in response to the detection of
the at least one physiological parameter by generating audible alerts to the patient via
the speaker. According to an embodiment, the therapy management component is
further configured to generate, via the speaker, audible alerts to the patient indicating
a delay in the administration of therapy to the patient.
[0024] According to an embodiment, the ambulatory medical device includes an
accelerometer coupled with the controller and the therapy management component is
configured to detect the at least one physiological parameter by detecting patient
motion via the accelerometer. According to an embodiment, the therapy management
component is further configured to increase the first predetermined period of time
responsive to detection of targeted patient motion. According to an embodiment, the
therapy management component is further configured to decrease the first
predetermined period of time responsive to detection of a patient fall. According to
an embodiment, the therapy management component is configured to delay the
administration of therapy a first amount of time and wherein the therapy management
component is further configured to delay the administration of therapy a second
amount of time responsive to detecting targeted patient motion within the first
predetermined period of time.
[0025] According to an embodiment, the ambulatory medical device includes a tactile
stimulator coupled with the controller and the therapy management component is
configured to request that the patient change the status in response to the detection of
the at least one physiological parameter by vibrating the ambulatory medical device
controller via the tactile stimulator. According to an embodiment, the therapy
management component is configured to delay the administration of therapy to the
patient in response to the detection of the first change in the status within the first
predetermined period of time by delaying the administration for a time interval
selected based on a severity of the health disorder. According to an embodiment, the
therapy management component is configured to request that the patient change the
status of at least two of the two or more response mechanisms in response to the
detection of the at least one physiological parameter and the identification of the
second mode as the operation mode.
[0026] According to an aspect, a method of delivering therapy to a patient using an
ambulatory medical device is provided. The ambulatory medical device being
configurable between a plurality of operation modes to delay administration of
therapy, the ambulatory medical device including a controller coupled with two or
more response mechanisms, each response mechanism of the two or more response
mechanisms having a status. The method comprises identifying, by the ambulatory
medical device, an active operation mode from the plurality of operation modes, the
plurality of operation modes including a first operation mode requiring changes in a
status of one of the two or more response mechanisms, and a second operation mode
requiring changes in a status of two of the two or more response mechanisms,
detecting, by the ambulatory medical device, at least one physiological parameter
having at least one value indicative of a health disorder of the patient, requesting that
the patient change the status of one of the two or more response mechanisms in
response to detecting the at least one physiological parameter and identifying the first
mode as the active operation mode, monitoring the status of the two or more response
mechanisms within a first predetermined period of time, and delaying administration
of therapy to the patient in response to detecting a first change in the status of one of
the one or more response mechanisms within the first predetermined period of time
and identifying the first mode as the active operation mode.
[0027] According to an embodiment, the method further includes requesting,
responsive to detecting the first change, that the patient change the status of the one or
more response mechanisms, and monitoring the status of the one or more response
mechanisms within a second predetermined period of time, wherein delaying the
administration of therapy to the patient includes delaying, responsive to detecting the
first change in the status within the first predetermined period of time and a second
change in the status within the second predetermined period of time, the
administration of therapy to the patient.
[0028] According to an embodiment, the ambulatory medical device includes at least
one electrocardiogram (ECG) sensor coupled with the controller and detecting, by the
ambulatory medical device, the at least one physiological parameter includes
detecting an ECG signal. According to an embodiment, the ambulatory medical
device is configured to deliver at least one defibrillating shock to the patient via at
least one therapy pad coupled with the controller and delaying the administration of
therapy to the patient in response to detecting the first change within the first
predetermined period of time includes delaying the delivery of the at least one
defibrillating shock. According to an embodiment, detecting, by the ambulatory
medical device, the at least one physiological parameter includes monitoring a cardiac
rhythm of the patient via the at least one ECG sensor. According to an embodiment,
detecting, by the ambulatory medical device, the at least one physiological parameter
having the at least one value indicative of the health disorder includes detecting at
least one physiological parameter having at least one value indicative of at least one
of ventricular tachycardia, ventricular defibrillation, bradycardia, tachycardia, erratic
heart rate, asystole, and pulseless electrical activity. According to an embodiment, the
ambulatory medical device includes a display coupled with the controller and
requesting that the patient change the status of at least one of the one or more
response mechanisms in response to detecting the at least one physiological parameter
includes displaying at least one notification to the patient via the display. According
to an embodiment, delaying the administration of therapy to the patient in response to
detecting the first change within the first predetermined period of time includes
displaying one or more notifications to the patient via the display.
[0029] According to an embodiment, the ambulatory medical device includes a
speaker coupled with the controller and requesting that the patient change the status in
response to detecting the at least one physiological parameter includes generating
audible alerts to the patient via the speaker. According to an embodiment, delaying
the administration of therapy to the patient in response to detecting the first change
within the first predetermined period of time includes generating audible alerts to the
patient via the speaker. According to an embodiment, the ambulatory medical device
includes an accelerometer coupled with the controller and detecting, by the
ambulatory medical device, the at least one physiological parameter further includes
detecting patient motion via the accelerometer. According to an embodiment,
detecting the first change in the status within the first predetermined period of time
includes increasing the first predetermined period of time responsive to detecting
targeted patient motion. According to an embodiment, detecting the first change in
the status within the first predetermined period of time includes decreasing the first
predetermined period of time responsive to detecting a patient fall. According to an
embodiment, delaying the administration of therapy includes delaying the
administration of therapy a first amount of time and wherein the method further
includes delaying the administration of therapy to the patient a second amount of time
responsive to detecting targeted patient motion within the first predetermined period
of time.
[0030] According to an embodiment, the ambulatory medical device includes a tactile
stimulator coupled with the controller and requesting that the patient change the status
in response to detecting the at least one physiological parameter includes vibrating the
ambulatory medical device controller via the tactile stimulator. According to an
embodiment, delaying, responsive to detecting the first change within the first
predetermined period of time, the administration of therapy to the patient includes
delaying the administration of therapy for a time interval selected based on a severity
of the health disorder. According to an embodiment, the one or more response
mechanisms include two or more response mechanisms and the method further
includes requesting that the patient change the status of at least two of the two or more
response mechanisms in response to detecting the at least one physiological parameter
and identifying the second mode as the active operation mode.
[0031] According to an aspect, a non-transitory computer readable medium storing
executable instructions configured to instruct at least one controller to perform a
method of delivering therapy is provided. The method comprises identifying, by the
ambulatory medical device, an active operation mode from the plurality of operation
modes, the plurality of operation modes including a first operation mode requiring
changes in a status of one of the two or more response mechanisms, and a second
operation mode requiring changes in a status of two of the two or more response
mechanisms, detecting, by the ambulatory medical device, at least one physiological
parameter having at least one value indicative of a health disorder of the patient,
requesting that the patient change the status of one of the two or more response
mechanisms in response to detecting the at least one physiological parameter and
identifying the first mode as the active operation mode, monitoring the status of the
two or more response mechanisms within a first predetermined period of time, and
delaying administration of therapy to the patient in response to detecting a first
change in the status of one of the one or more response mechanisms within the first
predetermined period of time and identifying the first mode as the active operation
mode.
[0032] 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 are intended to provide an overview or
framework for understanding the nature and character of the claimed subject matter.
Any embodiment disclosed herein may be combined with any other embodiment.
References to "an embodiment," "an example," "some embodiments," "some
examples," "an alternate embodiment," "various embodiments," "one embodiment,"
"at least one embodiment," "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 may be
included in at least one embodiment. The appearances of such terms herein are not
necessarily all referring to the same embodiment. In addition, the accompanying
drawings are included to provide illustration and a further understanding of the
various aspects and examples, 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 examples.
BRIEF DESCRIPTION OF DRAWINGS
[0033] 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 functional schematic of one example of an ambulatory medical
device controller;
FIG. 2 is an illustration of one example of an ambulatory medical device;
FIG. 3 is a flowchart of an example therapy delivery process;
FIG. 4 is a flowchart of an example process to determine patient condition;
FIGS. 5A-D are timelines of example treatment sequences; and
FIGS. 6A-B are illustrations of one example of an ambulatory medical device
controller.
DETAILED DESCRIPTION
[0034] Some embodiments disclosed herein relate generally to the administration of
therapy to a patient using an ambulatory medical device. The ambulatory medical
device may monitor any of a variety of physiological parameters to identify patient
health disorders and provide therapy accordingly. The patient may, however, require
delay or prevention of the therapy. In an embodiment, an ambulatory medical device
has a response mechanism including two response buttons that the patient may push
simultaneously to delay therapy. Requiring that a patient push both response buttons
simultaneously substantially reduces the likelihood that the patient accidentally
activated the response buttons to delay therapy, such as where the patient falls on the
ground and activates a single response button.
[0035] Patients with illnesses that cause fine motor skills to deteriorate, such as
diabetes and arthritis, may find it challenging to depress both response buttons
simultaneously. Accordingly, in some embodiments, an ambulatory medical device is
provided that is configured to accurately identify a state of patient responsiveness and
delay therapy where input is received that indicates the patient is responsive.
Examples of such input include a change in the status of one or more of the response
mechanisms after issuance of a request to the patient to do so.
[0036] More specifically, in at least some embodiments, an ambulatory medical
device is configurable to operate in at least two modes. The first mode may require
the patient to only activate and/or deactivate a single response button. The first mode,
however, may require a predefined sequence of activations and/or deactivations
within specific time intervals to successfully delay the administration of therapy.
Several examples of the predefined sequences performed in the first mode are
described further below in the Example Patient Monitoring and Treatment Scenarios
in a First Operating Mode section and FIGS. 5A-5D. The second mode may require
the patient to activate two response buttons to successfully delay treatment. Several
examples of the predefined sequences performed in the second mode are described
further below in the Example Patient Monitoring and Treatment Scenarios in a
Second Operating Mode section.
[0037] The examples of the methods and apparatus 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.
[0038] 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. In addition, 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.
Ambulatory Medical Device Controller
[0039] FIG. 1 illustrates an ambulatory medical device controller 100 that is
configured to monitor a patient and the patient' s environment for events of interest
and to delivery therapy to the patient as necessary. The ambulatory medical device
controller 100 may, for example, be configured for use in a wearable defibrillator. As
shown in FIG. 1, the ambulatory medical device controller 100 includes at least one
processor 118, a sensor interface 112, a therapy 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 patient data 116.
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. It is appreciated that some or all
of the components described with regard to the ambulatory medical device controller
100 may be located within or are integral to a protective housing of the ambulatory
device medical controller 100, such as the housing illustrated in FIGS. 6A and 6B.
[0040] According to the embodiment illustrated in FIG. 1, the processor 118 is
coupled with 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 are 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 U.S. Patent
Application Serial No. 12/833,096, titled "SYSTEM AND METHOD FOR
CONSERVING POWER IN A MEDICAL DEVICE," filed July 9, 2010 (hereinafter
the "'096 application"), which is hereby incorporated herein by reference in its
entirety. In another example, the processor 118 is an Intel® PXA270.
[0041] In addition, in several embodiments 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 to application software, such as
some examples of the therapy manager 114, which is discussed further below. These
platform services may include inter-process and network communication, file system
management and standard database manipulation. One or more of many operating
systems may be used, and examples may not be limited to any particular operating
system or operating system characteristic. For instance, in some examples, the
processor 118 may be configured to execute a non-real time operating system, such as
BSD or GNU/Linux.
[0042] In some embodiments, the therapy manager 114 is configured to monitor at
least one physiological parameter of a patient, detect health disorders, and administer
therapy to the patient as necessary. Particular examples of the processes performed
by the therapy manager 114 are discussed further below with reference to FIGS. 3-5
and within the Therapy Administration Processes section.
[0043] The therapy manager 114 may be implemented using hardware or a
combination of hardware and software. For instance, in one example, the therapy
manager 114 is implemented as a software component that is stored within the data
storage 112 and executed by the processor 118. In this example, the instructions
included in the therapy manager 114 program the processor 118 to monitor at least
one physiological parameter of a patient, detect health disorders, and administer
therapy to the patient as necessary. In other examples, therapy manager 114 may be
an application- specific integrated circuit (ASIC) that is coupled with the processor
118 and tailored to monitor at least one physiological parameter of a patient, detect
health disorders, and administer therapy to the patient as necessary. Thus, examples
of the therapy manager 114 are not limited to a particular hardware or software
implementation.
[0044] In some embodiments, the components disclosed herein, such as the therapy
manager 114, may read configuration parameters that affect the functions performed
by the components. These configuration parameters may be physically stored in any
form of suitable memory including volatile memory, such as RAM, or nonvolatile
memory, such as flash memory or a magnetic hard drive. In addition, the
configuration 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 examples provide for both system and user interfaces, as may be
implemented using the user interface 108, that allow external entities to modify the
configuration parameters and thereby configure the behavior of the components.
[0045] The data storage 104 includes a computer readable and writeable nonvolatile
data storage medium configured to store non-transitory instructions and data. In
addition, the data storage 104 includes 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
nonvolatile 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 nonvolatile storage medium after processing is
complete. A variety of components may manage data movement between the
nonvolatile 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.
[0046] The instructions stored on the data storage 104 may include executable
programs or other code that can be executed by the processor 118. The instructions
may be persistently stored as encoded signals, and the instructions may cause the
processor 118 to perform the functions described herein. 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. 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 ambulatory medical device
controller 100.
[0047] In some embodiments, the patient data 116 includes data used by the therapy
manager 114 to monitor at least one physiological parameter of a patient, detect health
disorders, and administer therapy to the patient as necessary. More particularly,
according to the illustrated example, the patient data 116 includes information that
identifies patient health disorder information and patient preferences. In an
embodiment, the ambulatory medical device controller 100 is configurable between
multiple modes of operation. The ambulatory medical device controller 100 may be
configured by trained personnel during a patient fitting and training process when the
ambulatory medical device is first issued to the patient. The patient may also
reconfigure the ambulatory medical device controller 100 in the field after the initial
fitting and training process. The configuration and/or reconfiguration process may
include, for example, a specific activation sequence to change the mode of operation
of the ambulatory medical device controller 100. One example of a configuration
process that may be used to change the mode of operation of the ambulatory medical
device controller 100 in the field is described within U.S. Patent Application Serial
No. 13/782,232, titled "SYSTEMS AND METHODS FOR CONFIGURING A
WEARABLE MEDICAL MONITORING AND/OR TREATMENT DEVICE," filed
March 1, 2013, which is hereby incorporated herein by reference in its entirety.
[0048] In some embodiments, the ambulatory medical device controller 100 is
configurable between two modes of operation. The first mode of operation allows the
patient to delay the administration of therapy in response to changing the status of one
or more response buttons within one or more predefined time intervals. The second
mode of operation allows the patient to delay the administration of therapy in
response to the patient changing the status of two or more response buttons
simultaneously. The first mode of operation may be suitable for patients with poor
dexterity or poor fine motor skills that find it difficult to push two or more response
buttons simultaneously. Example treatment sequences performed by the ambulatory
medical device controller 100 during operation in the first mode are described in the
Example Patient Monitoring and Treatment Scenarios in a First Operating Mode
section and FIGS. 5A-5D. The second mode of operation may allow the patient to
delay the administration of therapy in response to the patient changing the status of
two or more response buttons. Example treatment sequences performed by the
ambulatory medical device controller 100 during operation in the second mode are
described in the Example Patient Monitoring and Treatment Scenarios in a Second
Operating Mode section.
[0049] In an embodiment, the ambulatory medical device controller 100 configures
itself to operate in either the first or second mode of operation. For example, in some
embodiments the ambulatory medical device controller 100 may be configured to
operate in the second mode of operation (i.e., requires two buttons to be pushed
simultaneously to delay therapy) and detect that the patient cannot fully depress both
buttons simultaneously via one or more pressure sensors in each button. The
ambulatory medical device controller 100 may then configure itself to operate in the
first mode of operation (i.e., requires one button to be pushed to delay therapy). In
other embodiments, the ambulatory device may detect alternating button pushes or
repeated single button pushes and configure itself to operation in the first mode. It is
appreciated that the ambulatory medical device controller may also include a self-test
procedure. The self-test procedure, for example, may include requesting the patient to
push both buttons and determine whether the first or second mode operation is
appropriate for the particular patient.
[0050] It is appreciated that the first and second modes of operation may be applied to
other ambulatory medical device controller operations outside of the delay of therapy
administration. For example, power up self tests, health parameter recording (e.g.,
ECG), or any other activity may require the activation of one or more response
buttons in the first mode while requiring the activation of two or more response
buttons simultaneously in the second mode.
[0051] As illustrated in FIG. 1, the therapy manager 114 and the patient data 116 are
separate components. However, in other examples, the therapy manager 114 and the
patient data 116 may be combined into a single component or re-organized so that a
portion of the data included in the therapy manager 114, such as executable code that
causes the processor 118 to monitor at least one physiological parameter of a patient,
detect health disorders, and administer therapy to the patient as necessary, resides in
the patient data 116, 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.
[0052] The patient data 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. These data structures may be specifically configured to
conserve storage space or increase data exchange performance. In addition, various
examples organize the patient data 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, such as
integers, floating point numbers, character strings, arrays, linked lists, and the like.
[0053] As shown in FIG. 1, the ambulatory 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 housing of the ambulatory
medical device controller 100 or elsewhere. The interfaces 102, 106, and 112 may
include hardware components, software components or a combination of both.
Within each interface, these components physically and logically couple the
ambulatory medical device controller 100 to the specialized devices. This physical
and logical coupling enables the ambulatory medical device controller 100 to both
communicate with and, in some instances, power or control the operation of the
specialized devices. These specialized devices may include physiological sensors,
therapy delivery devices, and computer networking devices. It is appreciated that the
sensor interface 112 and the therapy delivery interface 102 may be combined to form
a single sensor and therapy delivery interface.
[0054] According to various examples, the hardware and software components of the
interfaces 102, 106 and 112 implement 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 ambulatory 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 examples
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.
[0055] 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, 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, acoustic sensors, and ECG electrodes (e.g., dry capacitive ECG electrodes),
one or more environmental sensors such as atmospheric thermometers, airflow
sensors, video sensors, audio sensors, accelerometers, GPS locators, and hygrometers.
In these examples, the sensors may include sensors with a relatively low sampling
rate, such as wireless sensors. An example acoustic sensor is described in co-pending
U.S. Patent Application Serial No. 14/314,799, titled "THERAPEUTIC DEVICE
INCLUDING ACOUSTIC SENSOR," filed June 25, 2014, which is hereby
incorporated herein by reference in its entirety.
[0056] The components of the therapy delivery interface 102 couple one or more
therapy delivery devices, such as capacitors and defibrillator 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, IEEE 802.15.4j,
BLUETOOTH, ZigBee, M-Bus, CAN-bus, IP, IPV6, UDP, DTN, HTTP, FTP,
SNMP, CDMA, NMEA and GSM. To ensure data transfer is secure, in some
examples, the ambulatory 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 ambulatory medical
device controller 100 and a variety of personal electronic devices including computer
enabled glasses and earpieces.
[0057] Thus, the various system interfaces incorporated in the ambulatory medical
device controller 100 allow the device to interoperate with a wide variety of devices
in various contexts. For instance, some examples of the ambulatory 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, titled "DATA
COLLECTION AND SYSTEM MANAGEMENT FOR PATIENT-WORN
MEDICAL DEVICES," issued on January 20, 2004, which is hereby incorporated
herein by reference in its entirety.
[0058] As illustrated in FIG. 1, the therapy delivery interface 102 and the network
interface 106 are optional and may not be included in every example. For instance, a
heart rate monitor may employ the ambulatory medical device controller 100 to issue
alarms but may not include a therapy delivery interface 102 to treat cardiac
abnormalities. Similarly, an ambulatory defibrillator may include the ambulatory
medical device controller 100 to provide alarm functionality but may not include a
network interface 106 where, for example, the ambulatory defibrillator is designed to
rely on the user interface 108 to announce alarms.
[0059] The user interface 108 shown in FIG. 1 includes a combination of hardware
and software components that allow the ambulatory medical device controller 100 to
communicate with an external entity, such as a patient or other user. These
components may be 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, 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. It is appreciated that
the user interface components described herein may be coupled with the user interface
108 of the ambulatory medical device controller 100 or included in the housing of the
ambulatory medical device controller.
[0060] The ambulatory medical device controller 100 has a variety of potential
applications and is well suited to devices that notify external entities of 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 alarm,
entry of information indicating that the alarm is being addressed and rectification of
the event or condition that triggered the alarm. Examples of devices to which the
ambulatory medical device controller 100 is well suited include critical care medical
devices, such as an ambulatory external defibrillator.
Example Ambulatory Medical Device
[0061] In an embodiment, the ambulatory medical device is a wearable defibrillator
that consists of a garment (e.g., a vest and/or belt) that is worn by the patient. The
wearable defibrillator monitors the patient's ECG with sensing electrodes, detects
life-threatening arrhythmias, and delivers a cardioverting or defibrillating shock
through therapy electrodes if treatment is necessary. FIG. 2 illustrates a wearable
defibrillator, such as a LifeVest® wearable cardioverter defibrillator available from
ZOLL Medical Corporation of Chelmsford, Massachusetts. As shown, the wearable
defibrillator 200 includes a harness 210 having a pair of shoulder straps and a belt that
is worn about the torso of a patient. The wearable defibrillator 200 includes a
plurality of ECG sensing electrodes 212 that are attached to the harness 210 at various
positions about the patient's body and electrically coupled with the sensor interface
112 of the ambulatory medical device controller 100 via a connection pod 230. The
plurality of ECG sensing electrodes 212, which may be dry-sensing capacitance
electrodes, long term wear adhesive electrodes, or conventional adhesive electrodes,
are coupled with the ambulatory medical device controller 100 to monitor the cardiac
function of the patient and generally include a front/back pair of ECG sensing
electrodes and a side/side pair of ECG sensing electrodes. Additional ECG sensing
electrodes may be provided, and the plurality of ECG sensing electrodes 212 may be
disposed at varying locations about the patient's body.
[0062] The wearable defibrillator 200 also includes a plurality of therapy electrodes
214 that are electrically coupled with the therapy delivery interface 102 of the
ambulatory medical device controller 100 via the connection pod 230 and which are
configured to deliver one or more therapeutic defibrillating shocks to the body of the
patient, if it is determined that such treatment is warranted. The connection pod 230
electrically couples the plurality of ECG sensing electrodes 212 and the plurality of
therapy electrodes 214 to the sensor interface 112 and the therapy delivery interface
102, respectively, of the ambulatory medical device controller 100, and may include
electronic circuitry. The connection pod 230 may also include other electronic
circuitry, such as a motion sensor or accelerometer through which patient activity may
be monitored.
[0063] As shown in FIG. 2, the wearable defibrillator 200 also includes a user
interface pod 240 that is electrically coupled with, or integrated with, the user
interface 108 of the ambulatory medical device controller 100. The user interface pod
240 can be attached to the patient's clothing or to the harness 210, for example, via a
clip (not shown) that is attached to a portion of the interface pod 240. Alternatively,
the user interface pod 240 may simply be held in a person's hand. In some
embodiments, the user interface pod 240 may communicate wirelessly with the user
interface 108 of the ambulatory medical device controller 100, for example, using a
BLUETOOTH, Wireless USB, ZigBee, Wireless Ethernet, GSM, or other type of
communication interface. The user interface pod 240 typically includes a number of
buttons by which the patient, or a bystander can communicate with the ambulatory
medical device controller 100, and a speaker by which the ambulatory medical device
controller 100 may communicate with the patient or the bystander. In one example,
the interface pod has two response buttons that the patient may communicate with the
ambulatory medical device controller 100 to delay the administration of therapy.
[0064] In another example, the functionality of the user interface pod 240 is
integrated into the housing of the ambulatory medical device controller 100. FIGS.
6A-B illustrate such an example of the ambulatory medical device controller 100.
The ambulatory medical device controller 100 includes a tactile response mechanism
comprising two response buttons 610 on opposing sides of the housing of the
ambulatory medical device controller 100. As shown in FIGS. 6A-B, the response
buttons 610 are recessed below a plane of an outer surface of the housing to reduce
the likelihood of accidental activation (e.g., a patient falling on and actuating the
response button). The ambulatory medical device controller 100 also includes, in this
example, a display screen 620 to enable the communication of visual stimuli to the
patient. In addition, the display screen 620 may also incorporate a touch screen to
enable the patient to interact with the ambulatory medical device controller 100. It is
appreciated that the response buttons 610 do not have to be placed on opposing sides
of the housing as illustrated in FIGS. 6A-B. The response buttons, for example, may
be located adjacent to each other in the housing of the ambulatory medical device
controller. The adjacent placement of the response buttons may make it easier for
individuals with smaller hands or less dexterity to engage the response buttons.
[0065] Where the ambulatory medical device controller 100 determines that the
patient is experiencing cardiac arrhythmia, the ambulatory medical device controller
100 may issue an audible alarm via a speaker and/or display a notification via the
display screen 620 on the ambulatory medical device controller 100, or the user
interface pod 240, alerting the patient and any bystanders to the patient's medical
condition. The ambulatory medical device controller 100 may also instruct the patient
to press and hold one or more response buttons 610 on the ambulatory medical device
controller 100, or on the user interface pod 240, to indicate that the patient is
conscious, thereby instructing the ambulatory medical device controller 100 to
withhold the delivery of one or more therapeutic defibrillating shocks. If the patient
does not respond, the device may presume that the patient is unconscious, and
proceed with the treatment sequence, culminating in the delivery of one or more
defibrillating shocks to the body of the patient.
[0066] It is appreciated that the response mechanism employed by the ambulatory
medical device controller may not be limited to two response buttons. For example,
the response mechanism of the ambulatory medical device controller 100 may
incorporate one or more microphones to enable the ambulatory medical device
controller 100 to receive voice commands from the patient. In this example, the
ambulatory medical device controller 100 may request that the patient say a specific
phrase to delay the administration of therapy.
Therapy Administration Processes
[0067] Various embodiments implement and enable processes through which an
ambulatory medical device controller, such as the ambulatory medical device
controller 100 described above with reference to FIG. 1, administers therapy to a
patient. FIG. 3 illustrates one such process 300 that includes acts of detecting a health
disorder 302, determining patient condition 304, and administering therapy 306.
[0068] In the act 302, the ambulatory medical device controller detects a health
disorder of the patient. In an embodiment, the act 302 includes monitoring at least
one physiological parameter of the patient having at least one value potentially
indicative of a health disorder. For example, the ambulatory medical device
controller may monitor a cardiac rhythm of the patient and detect one or more heart
arrhythmia health disorders. Specific examples of detectable heart arrhythmia health
disorders include, but are not limited to, premature ventricular contraction, ventricular
defibrillation, bradycardia, tachycardia (e.g., ventricular tachycardia, supraventricular
tachycardia, and sinus tachycardia), an erratic heart rate with no discernible sinus
rhythm, asystole, or pulseless electrical activity. The ambulatory medical device
controller may use any of a variety of methods to detect health disorders. In one
example, the ambulatory medical device controller stores information regarding
normal readings of the physiological parameter. In this example, the ambulatory
medical device controller includes signal processing capabilities and matches the
incoming readings with the stored known normal patient readings that characterize the
patient's normal cardiac function. The matching process could be implemented in a
variety of methods including a matched filtering process. An example system and
method for detecting health disorders relating to cardiac arrhythmias is described in
co-pending U.S. Patent Application Serial No. 13/428,329, titled "SELECTION OF
OPTIMAL CHANNEL FOR RATE DETERMINATION," filed March 23, 2013,
which is hereby incorporated herein by reference in its entirety. Another example
system and method for detecting health disorders relating to cardiac arrhythmias is
described in U.S. Patent No. 8,706,215, titled "WEARABLE AMBULATORY
MEDICAL DEVICE WITH MULTIPLE SENSING ELECTRODES," issued April
22, 2014, which is hereby incorporated herein by reference in its entirety.
[0069] In the act 304, the ambulatory medical device controller determines a patient
condition. Determining the patient condition may include identifying a state of
responsiveness of the patient. Actions performed by the ambulatory medical device
controller during execution of the act 304 are described further below with reference
to FIG. 4.
[0070] In the act 306, the ambulatory medical device controller administers therapy to
the patient. In some examples where the ambulatory medical device controller is
coupled with one or more therapy electrodes, the ambulatory medical device
controller delivers one or more therapeutic shocks to the patient. After the act 306,
the ambulatory medical device controller terminates the process 300. It is appreciated
that the ambulatory medical device controller may execute the process 300 again if
the initial administration of therapy did not resolve all of the health disorders of the
patient.
[0071] As discussed above with regard to the act 304 in FIG. 3, various embodiments
implement processes for determining patient condition (e.g., identifying a state of
responsiveness of the patient). FIG. 4 illustrates one such process 400 that
implements the act 304 and that includes acts of notifying the patient of a health
disorder 402, requesting a response from the patient 404, determining whether the
response was received 406, and delaying therapy if the response was received 408.
[0072] In the act 402, the ambulatory medical device controller notifies the patient of
the health disorder. In one example, the ambulatory medical device controller,
through the user interface 108, displays a patient notification on a display screen,
transmits an audible alert via a speaker to the patient or both. The audible alert may
include a siren or specific alerts stated by a voice that notify the patient audibly. In
other examples, a tactile stimulator is housed in or coupled with the ambulatory
medical device controller to notify the patient. The tactile stimulator may include a
motor with an unbalanced weight on its shaft. When the motor is on, it causes the belt
to vibrate much like a cell-phone in vibration mode. It is appreciated that the tactile
stimulator may be activated by the ambulatory medical device controller during any
patient notification, alert, or siren.
[0073] In the act 404, the ambulatory medical device controller requests a targeted
response from the patient. The response from the patient is received by a response
mechanism of the ambulatory medical device controller. In an embodiment, the
response mechanism comprises two response buttons coupled with or integrated with
the ambulatory medical device. The patient may communicate with the ambulatory
medical device controller through activating or deactivating one or both of the
response buttons. In the act 404, the ambulatory medical device controller requests
that the patient change the status of one response button (e.g., change the response
button from a deactivated state to an activated state or vice-versa) within a
predetermined amount of time. If the patient successfully performs the requested
response, the ambulatory medical device may request that the patient again change the
status of the same response button within another predetermined amount of time.
Such sequences of requests and responses may be repeated one or more times to
ensure the patient does not require treatment.
[0074] It is appreciated that a change in status of both response buttons may be
recorded by the medical device controller as a successful patient response. In other
embodiments, the ambulatory medical device controller may require any number of
response button changes prior to recording a successful patient response and delaying
the administration of therapy to the patient. It is also appreciated that the ambulatory
medical device controller may include any number of response buttons and may
request that the patient push any combination of response buttons to delay the
administration of therapy.
[0075] In another embodiment, the response mechanism includes a touch screen
coupled with or integrated with the ambulatory medical device controller. The patient
communicates with the ambulatory medical device controller by interacting with the
touch screen. For example, the patient may press a button displayed on the touch
screen of the ambulatory medical device. If the patient successfully touches the
button on the touch screen, the ambulatory medical device may relocate the button on
the touch screen and request that the patient press the relocated button on the touch
screen again.
[0076] In other embodiments, the response mechanism includes patient voice
recognition through one or more microphones coupled with or integrated with the
ambulatory medical device controller. For example, in one embodiment, the
ambulatory medical device controller may request the patient say a specific phrase to
the ambulatory medical device controller.
[0077] In the act 406, the ambulatory medical device controller determines whether
the requested action was performed. In an embodiment, the ambulatory medical
device controller notifies the patient that administration of the therapy will be delayed
or canceled when the patient successfully performs the requested action in two
instances in succession. This notification may include any combination of audible,
visual, and tactile output. In some embodiments, the ambulatory medical device
controller determines whether the administration of the therapy is delayed or canceled
based on a value of a predefined configuration parameter.
[0078] In another embodiment, the act 406 further includes reading one or more
accelerometers communicatively connected to or integrated with the ambulatory
medical device controller. The readings from the one or more accelerometers may be
used to determine a state of consciousness of the patient through the detection of
targeted patient activity. The ambulatory medical device controller may delay the
administration of therapy responsive to detecting a conscious patient (e.g., detecting
targeted patient activity). For example, the accelerometers may detect that the patient
is walking and delay the administration of therapy. This delay of the administration
of therapy responsive to patient activity may be independent of the requested action
(e.g., change the status of a response button) or, where the patient responds with the
requested action, may further increase the delay that would have resulted from the
patient solely successfully performing the requested action. It is appreciated that the
accelerometer may be employed by the ambulatory medical device controller to detect
a patient fall and shorten delays and/or administer therapy to the patient responsive to
the detected patient fall. In addition, other sensors may be used to determine the state
of consciousness of the patient including, but not limited to, a microphone to detect
patient speech, an acoustic sensor to detect viable respiration, and two or more
response mechanisms that require patient activation (e.g., in the second mode of
operation described herein).
[0079] As described above, in some embodiments, one or more response buttons are
coupled with or integrated in the ambulatory medical device controller. In these
embodiments, the ambulatory medical device controller monitors the status of the
response buttons within the act 406. The ambulatory medical device controller may
ignore a specific response button in the event that the button remains in an activated
state for a period of time longer than a predetermined duration (e.g., the button is
jammed where, for example, the patient has fallen on the controller in a manner in
which the button is held in an activated state).
[0080] In another embodiment, the ambulatory medical device controller is
configured to determine whether any actions requested and performed are performed
by the patient. The ambulatory medical device may make this determination with
reference to a body marker transmitted through the patient from the response button to
electrodes on the patient such as described in U.S. Patent No. 8,271,082, titled
"MEDICAL DEVICE CONFIGURED TO TEST FOR USER RESPONSIVENESS,"
issued on September 18, 2012, which is hereby incorporated herein by reference in its
entirety. In embodiments where the patient is requested to audibly reply to the
ambulatory medical device controller, patient voice recognition may be employed as
described in U.S. Patent No. 8,369,944 titled "WEARABLE DEFIBRILLATOR
WITH AUDIO INPUT/OUTPUT," issued on February 5, 2013, which is hereby
incorporated herein by reference in its entirety.
[0081] After the therapy has been delayed in the act 408, the ambulatory medical
device controller repeats the act 404 to ensure the patient remains conscious. A
specific length of the delay may be selected responsive to the severity of the health
disorder. In an embodiment, the ambulatory medical device controller monitors the
cardiac rhythm of a patient to detect arrhythmias. The ambulatory medical device
controller may detect, for example, ventricular tachycardia and set the delay to 30
seconds. When the ambulatory medical device controller detects a health disorder
that is more severe, for example ventricular fibrillation, the ambulatory medical
device controller may shorten the delay to 15 seconds. It is appreciated that the cycle
of requesting a specific action from the patient and delaying therapy accordingly may
be limited to a finite number of cycles before automatically delivering therapy.
Referring back to the act 406, the ambulatory medical device controller will proceed
to complete the process 400 if the patient does not respond as required or has
successfully delayed therapy up to a maximum predetermined amount of time. It is
also appreciated that the ambulatory medical device controller may terminate the
process 300 or the process 400 when the ambulatory medical device controller ceases
to detect a health disorder of the patient for a predetermined period of time.
[0082] 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 medical device 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 an ambulatory medical device
controller configured to operate in one or more modes of operation according to the
examples disclosed herein.
Example Patient Monitoring and Treatment Scenarios in a First Operating Mode
[0083] Various embodiments implement and enable various scenarios through which
an ambulatory medical device controller operating in a first operating mode, such as
the ambulatory medical device controller 100 described above with reference to FIG.
1, administers therapy to a patient. In some embodiments, the first mode of operation
allows the patient to delay the administration of therapy in response to changing the
status of one or more response buttons within one or more predefined time intervals.
FIGS. 5A-D illustrate timelines of example treatment sequences for the administration
of therapy (e.g., a defibrillating shock) to a patient by the ambulatory medical device
controller while operating in a first operation mode. These treatment sequences
include a cardiac rhythm monitoring sequence 502 with cardiac rhythm detection
activities 516A-D, a arrhythmia declaration sequence 504 with arrhythmia declaration
activities 518A-D, a response button sequence 506 with response button activities
520A-D, a screen sequence 508 with patient notification activities 522A-C, an audio
and tactile sequence 510 with a vibrate activity 524, a siren activity 526, and alert
activities 528A-D, a converter sequence 512 with a converter on activity 530, a
converter off activity 532, an apply gel activity 534, and a transmit pulse activity 536,
and an elapsed time sequence 514.
[0084] In a scenario 500A illustrated in FIG. 5A, the cardiac rhythm of a patient is
continuously monitored in an activity 516A as seen on the cardiac rhythm sequence
502. The ambulatory medical device controller detects a cardiac arrhythmia event
518A seen on the arrhythmia declaration sequence 504. The ambulatory medical
device controller subsequently displays a patient notification during patient
notification activity 522A on the screen sequence 508. The patient notification may
display text, for example, stating "Patient Respond." During this patient notification,
the ambulatory medical device controller vibrates during vibrate activity 524 on the
audio and tactile sequence 510. The vibrate activity 524 (e.g., vibrating the
ambulatory medical device controller and/or a tactile stimulator disposed in the
connection pad 230) and the display patient notification activity 522A are followed by
sirens during siren activity 526 on the audio and tactile sequence 510. While the
ambulatory medical device controller is alerting the patient through sirens, the
converter turns on during converter on activity 530 on the converter sequence 512 in
preparation for the administration of a therapeutic shock to the patient. Turning the
converter on may enable a capacitor bank configured to deliver a large amount of
energy to the patient through a therapeutic shock to charge from a battery source in
the ambulatory medical device controller.
[0085] An audible alert activity 528A is then communicated to the patient and is
followed by a siren activity 526 as shown on the audio and tactile sequence 510. For
example, the ambulatory medical device controller may state "press response button
to delay treatment" in the event that the response button's initial state is deactivated as
shown in response button activity 520A on the response button sequence 506. The
patient then responds accordingly to the patient notification activity 522A and the
audible alert activity 528A and pushes the response button at the zero second mark on
the elapsed time sequence. The converter is turned off during a converter off activity
532 as shown on the converter sequence 512 shortly after the zero second mark. In
response to the patient's response and turning off the converter, the ambulatory
medical device controller proceeds to notify the patient at the zero second mark
through the patient notification activity 522B and the corresponding alert activity
528B that the patient has successfully completed the requested response. The patient
notification activity 522B may display "treatment being delayed" and the audible alert
activity 528B may recite "treatment has been delayed, bystanders do not interfere."
The delay proceeds for approximately 25 seconds punctuated by the repeated audible
alert activities 528B to the patient because the response button remains in an active
state.
[0086] After about 25 seconds (i.e., at or about the 25 second mark of the elapsed
time sequence 514), the ambulatory medical device controller requests an additional
action be performed by the patient to verify patient responsiveness. The ambulatory
medical device controller issues a patient notification during the patient notification
activity 522C and may display "please let go of response button" as shown on the
screen sequence 508. This notification is accompanied by siren activity 526 followed
by an alert activity 528C that may state "please let go of response button" as shown
on the audio and tactile sequence 510. The ambulatory medical device controller then
turns on the converter in converter on activity 530 shortly after the 30 second mark of
the elapsed time sequence 514 to ready the ambulatory medical device controller to
deliver a therapeutic shock. The audible alert activities 528C and siren activities 526
continue until shortly after the 45 second mark on the elapsed time sequence 514
where gel is applied during the apply gel activity 534 on the converter sequence 512.
The gel may be applied from therapy electrodes coupled with the ambulatory medical
device controller to improve the transfer of energy from the therapy electrodes to the
patient during the administration of the therapeutic shock. The ambulatory medical
device controller proceeds to issue an audible alert during an alert activity 528D that
may state "bystanders, do not touch patient" as shown on the audio and tactile
sequence 510. The ambulatory medical device controller proceeds to transmit a
defibrillating pulse of energy during the transmit pulse activity 536 as shown on the
converter sequence 512 at the 55 second mark on the elapsed time sequence 514. It is
appreciated that a second pulse may be transmitted if the arrhythmia continues and the
patient fails to respond to additional requests from the ambulatory medical device
controller.
[0087] In scenario 500B of FIG. 5B, the cardiac rhythm of a patient is continuously
monitored in an activity 516B and a cardiac arrhythmia event 518B occurs similar to
scenario 500A as described above with regard to FIG. 5A. The ambulatory medical
device controller executes the same initial process of issuing a patient notification
522A, an audible alert activity 528A, a vibrate activity 524, and a siren activity 526
prior to requesting the patient to push the response button in a patient notification
activity 522B and an alert activity 528B. The ambulatory medical device controller
delays the administration of therapy in response to the requested action (e.g., pushing
the response button) being successfully completed by the patient. Next, the
ambulatory device controller requests that the patient release the response button via a
patient notification activity 522C and an alert activity 528C between the 25 and 30
second marks on the elapsed time sequence 514. At about the 35 second mark of the
elapsed time sequence 514, the patient releases the response button and subsequently
activates the response button as shown in a response button activity 520B on the
response button sequence 506. The ambulatory medical device controller
subsequently notifies the patient that the response was successfully performed as
shown through a patient notification activity 522B and an alert activity 528B shortly
after the 35 second mark of the elapsed time sequence 514. The ambulatory medical
device controller proceeds to delay 25 seconds (i.e., until the 60 second mark on the
elapsed time sequence 514) prior to asking the patient to release the response button
through a patient notification activity 522C and a corresponding alert activity 528C.
In this scenario, however, the response button is not released as shown in the
responsive button activity 520B of the response button sequence. The patient may
have fallen unconscious and accidentally fallen on the response button. The
ambulatory medical device controller accordingly administers therapy using the same
sequence as described with regard to scenario 500A but between the 65 and 95 second
marks on the elapsed sequence 514 of FIG. 5B. It is appreciated that a second pulse
may be transmitted if the arrhythmia continues and the patient fails to respond to
additional requests from the ambulatory medical device controller.
[0088] In scenario 500C of FIG. 5C, the cardiac rhythm of a patient is monitored in
an activity 516C and a cardiac arrhythmia event 518C occurs similar to scenario 500A
as described above with regard to FIG. 5A. The ambulatory medical device controller
executes the same initial process of issuing a patient notification activity 522A, an
audible alert activity 528A, a vibrate activity 524, and siren activities 526 prior to
requesting the patient to push the response button in a patient notification activity
522B and an alert activity 528B. The ambulatory medical device controller delays the
administration of therapy in response to the requested action (e.g., pushing the
response button) being successfully completed by the patient. Next, the ambulatory
device controller requests that the patient release the response button via a patient
notification activity 522C and an alert activity 528C between the 25 and 30 second
marks on the elapsed time sequence 514. The release of the response button at the 35
second mark on the elapsed time sequence occurs shortly after the ambulatory
medical device controller requests the release of the response button. The device
subsequently delays the administration of therapy 538 a period of time before
repeating the process (e.g., beginning with a patient notification activity 522A and a
vibrate activity 524). The length of the delay may be based upon the detected health
disorder of the patient. In some embodiments, the ambulatory medical device
controller is configured to delay the administration of therapy 15 seconds for
ventricular defibrillation disorders and 30 seconds for ventricular tachycardia
disorders.
[0089] In scenario 500D of FIG. 5D, the cardiac rhythm of a patient is continuously
monitored in an activity 516D. The ambulatory medical device controller detects a
cardiac arrhythmia event 518D. As shown in response button activity 520D on the
response button sequence 506, the ambulatory medical device controller detects that
the response button is already in the activated position when the arrhythmia is
detected at the event 518D. The ambulatory medical device controller subsequently
issues a patient notification activity 522C requesting the patient to release the
response button. The patient notification activity 522C is accompanied by siren
activity 526 and a vibrate activity 524 followed by an audible alert activity 528C
requesting the patient release the response button. In this scenario, the patient fails to
response to the audible and visual requests to release the response button, and the
ambulatory medical device controller consequently delivers therapy to the patient
using a similar sequence as previously described with regard to scenario 500A
between the 25 and 55 second marks on the elapsed sequence 514 of FIG. 5A . It is
appreciated that a second pulse may be transmitted if the arrhythmia continues and the
patient fails to respond to additional requests from the ambulatory medical device
controller. While the example scenarios disclosed herein recite specific treatment
sequences, the treatment sequences in each scenario may be altered without departing
from the scope of the embodiments disclosed herein. For example, the activated and
deactivated states of the response button may be interchanged.
[0090] It is appreciated that the treatment sequences described with reference to the
first mode of operation and FIGS. 5A-D are not limited to ambulatory medical device
controllers operating in the first mode of operation or ambulatory medical device
controllers with multiple modes of operation. The treatment sequences may be
applied to ambulatory medical device controllers operating in any mode of operation
(e.g., the second mode of operation described herein). In addition, the response
button may be replaced with one or more other response mechanisms. Other possible
response mechanisms include, for example, a button on the touch screen and patient
voice recognition.
Example Patient Monitoring and Treatment Scenarios in a Second Operating Mode
[0091] Various embodiments implement and enable various scenarios through which
an ambulatory medical device controller operating in the second operating mode, such
as the ambulatory medical device controller 100 described above with reference to
FIG. 1, administers therapy to a patient. In some embodiments, the second mode of
operation allows the patient to delay the administration of therapy in response to
changing the status of two or more response buttons.
[0092] In some embodiments, the ambulatory medical device controller detects an
arrhythmia and requests the patient to depress two buttons simultaneously. In these
embodiments, the ambulatory medical device controller delays administration of
therapy responsive to the activation of two response buttons simultaneously or within
a predetermined period of time. The therapy may be delayed responsive to the patient
activating both response buttons.
[0093] In an embodiment, the ambulatory medical device controller delays the
administration of therapy until the patient releases one or two of the buttons. If the
patient releases one or two of the response buttons, the ambulatory medical device
controller may request that the patient push two response buttons again. Otherwise,
the ambulatory medical device controller may administer therapy to the patient.
[0094] It is appreciated that the treatment sequences described with reference to the
second operation mode may not be limited to ambulatory medical device controllers
operating in the second mode of operation or ambulatory medical device controllers
with multiple modes of operation. The treatment sequences may be applied to
ambulatory medical device controllers operating in any mode of operation (e.g., the
first mode of operation). In addition, the response button may be replaced with one or
more other response mechanisms. Other possible response mechanisms include a
button on the touch screen and patient voice recognition.
[0095] Having thus described several aspects of at least one embodiment of this
invention, 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. An ambulatory medical device capable of delivering therapy to a patient, the
ambulatory medical device comprising:
at least one response mechanism having a state;
a controller coupled with the at least one response mechanism, the controller
including at least one processor coupled with a memory; and
a therapy manager component executable by the controller and configured to:
detect a physiological parameter having a value indicative of a health
disorder of the patient;
request the patient change the state in response to the detection of the
physiological parameter;
monitor the state within a first predetermined period;
delay administration of therapy to the patient in response to detection
of a change in the state within the first predetermined period;
monitor the state for a second predetermined period;
request the patient change the state in response to detection of the state
remaining unchanged during the second predetermined period; and one of
further delay the administration of therapy in response to detection of a
change in the state during the second predetermined period; and
prepare to deliver the therapy to the patient in response to the state
remaining unchanged until expiration of the second predetermined period.
2. The ambulatory medical device according to claim 1, wherein the ambulatory
medical device further comprises:
at least one therapy pad coupled with the controller; and
at least one ECG sensor coupled with the controller.
3. The ambulatory medical device according to claim 2, wherein the ambulatory
medical device is further configured to deliver at least one defibrillating shock to
the patient via the at least one therapy pad; and wherein the therapy management
component is configured to delay the administration of therapy to the patient by
delaying the administration of the at least one defibrillating shock.
4. The ambulatory medical device according to claim 2, wherein the therapy
management component is further configured to detect the physiological
parameter by monitoring a cardiac rhythm of the patient via the at least one ECG
sensor.
5. The ambulatory medical device according to any of claims 1-4, wherein the
health disorder includes at least one of ventricular tachycardia, ventricular
defibrillation, bradycardia, tachycardia, erratic heart rate, asystole, and pulseless
electrical activity.
6. The ambulatory medical device according to claim 5, wherein the therapy
management component is further configured to further delay the administration
of therapy to the patient by further delaying the administration of therapy for a
duration that is greater for ventricular tachycardia than for ventricular
defibrillation.
7. The ambulatory medical device according to any of claims 1-4, wherein the
ambulatory medical device includes a display coupled with the controller; and
wherein the therapy management component is further configured to display, via
the display, at least one notification requesting that the patient change the state of
the at least one response mechanism.
8. The ambulatory medical device according to claim 7, wherein the therapy
management component is further configured to display, via the display, one or
more notifications to the patient indicating a delay in the administration of
therapy to the patient.
9. The ambulatory medical device according to any of claims 1-4, wherein the
ambulatory medical device includes an audible alert unit coupled with the
controller; and wherein the therapy management component is further configured
to request that the patient change the state in response to the detection of the
physiological parameter by generating audible alerts to the patient via the audible
alert unit.
10. The ambulatory medical device according to claim 9, wherein the therapy
management component is further configured to generate, via the audible alert
unit, audible alerts to the patient indicating a delay in the administration of
therapy to the patient.
11. The ambulatory medical device according to any of claims 1-4, wherein the
therapy management component is further configured to monitor a state of
consciousness of the patient.
12. The ambulatory medical device according to claim 11, wherein the ambulatory
medical device further comprises an accelerometer coupled with the controller;
and wherein the therapy management component is configured to monitor the
state of consciousness of the patient by monitoring patient motion.
13. The ambulatory medical device according to claim 12, wherein the therapy
management component is further configured to delay the administration of
therapy in response to detection of targeted patient motion.
14. The ambulatory medical device according to claim 12, wherein the therapy
management component is further configured to administer therapy to the patient
in response to detection of a patient fall.
15. The ambulatory medical device according to claim 1, wherein the ambulatory
medical device includes a tactile stimulator coupled with the controller; and
wherein the therapy management component is further configured to request the
patient change the state of the at least one response mechanism by vibrating the
ambulatory medical device controller via the tactile stimulator.
16. The ambulatory medical device according to any of claims 1-4, wherein the
therapy management component is configured to delay the administration of
therapy to the patient in response to the detection of a change in the state of the at
least one response mechanism within the second predetermined period by
delaying the administration of therapy an interval of time selected based on a
severity of the health disorder.
17. The ambulatory medical device according to any of claims 1-4, wherein the at
least one response mechanism includes at least one response button operable to
change the state of the at least one response mechanism.
18. The ambulatory medical device according to claim 17, wherein the at least one
response mechanism has a deactivated state and an activated state; and wherein
the at least one response button is operable to change the state between the
deactivated state and the activated state.
19. A method of delivering therapy to a patient using an ambulatory medical device,
the ambulatory medical device including a controller coupled with at least one
response mechanism having a state, the method comprising:
detecting, by the ambulatory medical device, a physiological parameter having
a value indicative of a health disorder of the patient;
requesting the patient change the state in response to detecting the
physiological parameter;
monitoring the state within a first predetermined period;
delaying administration of therapy to the patient in response to detecting a
change in the state within the first predetermined period;
monitoring the state for a second predetermined period;
requesting the patient change the state in response to detecting the state
remaining unchanged during the second predetermined period; and one of
further delaying the administration of therapy in response to detection of a
change in the state during the second predetermined period; and
preparing to deliver the therapy to the patient in response to the state
remaining unchanged until expiration of the second predetermined period.
20. The method according to claim 19,
wherein the ambulatory medical device includes at least one
electrocardiogram (ECG) sensor coupled with the controller;
and wherein detecting, by the ambulatory medical device, the
physiological parameter includes detecting an ECG signal.
21. The method according to claim 20, wherein the ambulatory medical device is
configured to deliver at least one defibrillating shock to the patient via at least
one therapy pad coupled with the controller; and wherein delaying the
administration of therapy to the patient includes delaying the delivery of the at
least one defibrillating shock.
22. The method according to claim 20, wherein detecting, by the ambulatory medical
device, the physiological parameter includes monitoring a cardiac rhythm of the
patient via the at least one ECG sensor.
23. The method according to any of claims 19-22, wherein detecting, by the
ambulatory medical device, the physiological parameter having the value
indicative of the health disorder includes detecting the physiological parameter
having the value indicative of at least one of ventricular tachycardia, ventricular
defibrillation, bradycardia, tachycardia, erratic heart rate, asystole, and pulseless
electrical activity.
24. The method according to any of claims 19-22, wherein the ambulatory medical
device includes a display coupled with the controller; and wherein requesting that
the patient change the state includes displaying at least one notification to the
patient via the display.
25. The method according to claim 24, wherein delaying the administration of
therapy to the patient in response to detecting a change in the state includes
displaying one or more notifications to the patient via the display.
26. The method according to any of claims 19-22, wherein the ambulatory medical
device includes an audible alert unit coupled with the controller; and wherein
requesting that the patient change the state includes generating audible alerts to
the patient via the audible alert unit.
27. The method according to claim 26, wherein delaying the administration of
therapy to the patient in response to detecting a change in the state includes
generating audible alerts to the patient via the audible alert unit.
28. The method according to any of claims 19-22, wherein the method further
comprises monitoring a state of consciousness of the patient.
29. The method according to claim 28, wherein the method further comprises
delaying the administration of therapy to the patient in response to detecting a
change in the state within the first predetermined period and a conscious patient
in the second predetermined period.
30. The method according to claim 29, wherein the ambulatory medical device
further comprises an accelerometer coupled with the controller; and wherein
monitoring the state of consciousness of the patient includes monitoring patient
motion.
31. The method according to claim 29, wherein the method further comprises
administering therapy to the patient in response to detecting a patient fall.
32. The method according to any of claims 19-22,
wherein the ambulatory medical device includes a tactile stimulator
coupled with the controller; and
wherein requesting that the patient change the state includes vibrating the
ambulatory medical device controller via the tactile stimulator.
33. The method according to any of claims 19-22, wherein delaying further the
administration of therapy to the patient in response to detecting a change in the
state includes delaying the administration of therapy for a time interval selected
based on a severity of the health disorder.
34. A non-transitory computer readable medium storing executable instructions
configured to instruct at least one controller to perform a method of delivering
therapy according to any of claims 19-22.
35. An ambulatory medical device capable of delivering therapy to the patient and
configurable between a plurality of operation modes to delay administration of
therapy, the ambulatory medical device comprising:
two or more response mechanisms each having a state;
a memory storing an active operation mode parameter identifying an active
operation mode from the plurality of operation modes, the plurality of operation
modes including a first operation mode requiring changes in a state of one of the
two or more response mechanisms, and a second operation mode requiring
changes in states of two of the two or more response mechanisms;
a controller coupled with the two or more response mechanisms, the controller
including at least one processor coupled with the memory; and
a therapy manager component executable by the controller and configured to:
identify the active operation mode from the plurality of operation modes;
detect a physiological parameter having a value indicative of a health
disorder of the patient;
request, in response to detection of the at least one physiological parameter
and identification of the first operation mode as the active operation mode, that the
patient change the state of one of the two or more response mechanisms in
response to detection of the physiological parameter and the identification of the
first mode as the active operation mode;
monitor the state of each of the two or more response mechanisms within a
first predetermined period; and
delay administration of therapy to the patient in response to detection of a
first change in the state of one of the two or more response mechanisms within the
first predetermined period and the identification of the first mode as the active
operation mode.
36. The ambulatory medical device according to claim 35, wherein the therapy
management component is further configured to:
request, in response to the detection the first change, that the patient change
the state of one of the two or more response mechanisms; and
monitor the state of each of the two or more response mechanisms within a
second predetermined period,
wherein the therapy management component is configured to delay the
administration of therapy by delaying, in response to the detection of the first
change in the state within the first predetermined period and a second change in
the state within the second predetermined period, the administration of therapy to
the patient.
37. The ambulatory medical device according to claim 35, wherein the ambulatory
medical device further comprises:
at least one therapy pad coupled with the controller; and
at least one ECG sensor coupled with the controller.
38. The ambulatory medical device according to claim 37,
wherein the ambulatory medical device is configured to deliver at least one
defibrillating shock to the patient via the at least one therapy pad; and
wherein the therapy management component is configured to delay in
response to the detection of the first change in the state within the first
predetermined period the administration of therapy to the patient by delaying the
administration of the at least one defibrillating shock.
39. The ambulatory medical device according to claim 37, wherein the therapy
management component is configured to detect the physiological parameter by
monitoring a cardiac rhythm of the patient via the at least one ECG sensor.
40. The ambulatory medical device according to any of claims 35-39, wherein the
health disorder of the patient comprises at least one of ventricular tachycardia,
ventricular defibrillation, bradycardia, tachycardia, erratic heart rate, asystole,
and pulseless electrical activity.
41. The ambulatory medical device according to claim 40, wherein the therapy
management component is configured to delay the administration of therapy to
the patient by delaying the administration of therapy for a duration that is greater
for ventricular tachycardia than for ventricular defibrillation.
42. The ambulatory medical device according to any of claims 35-39, wherein the
ambulatory medical device includes a display coupled with the controller; and
wherein the therapy management component is further configured to display, via
the display, at least one notification requesting that the patient change the state.
43. The ambulatory medical device according to claim 42, wherein the therapy
management component is further configured to display, via the display, one or
more notifications to the patient indicating a delay in the administration of
therapy to the patient.
44. The ambulatory medical device according to any of claims 35-39, wherein the
ambulatory medical device includes an audible alert unit coupled with the
controller; and wherein the therapy management component is configured to
request that the patient change the state in response to the detection of the
physiological parameter by generating audible alerts to the patient via the audible
alert unit.
45. The ambulatory medical device according to claim 44, wherein the therapy
management component is further configured to generate, via the audible alert
unit, audible alerts to the patient indicating a delay in the administration of
therapy to the patient.
46. The ambulatory medical device according to any of claims 35-39, wherein the
ambulatory medical device includes an accelerometer coupled with the
controller; and wherein the therapy management component is configured to
detect the physiological parameter by detecting patient motion via the
accelerometer.
47. The ambulatory medical device according to claim 46, wherein the therapy
management component is further configured to increase the first predetermined
period in response to detection of targeted patient motion.
48. The ambulatory medical device according to claim 46, wherein the therapy
management component is further configured to decrease the first predetermined
period in response to detection of a patient fall.
49. The ambulatory medical device according to claim 46, wherein the therapy
management component is configured to delay the administration of therapy a
first amount of time; and wherein the therapy management component is further
configured to delay, in response to detecting targeted patient motion within the
first predetermined period, the administration of therapy a second amount of time
greater than the first amount of time.
50. The ambulatory medical device according to any of claims 35-39, wherein the
ambulatory medical device includes a tactile stimulator coupled with the
controller; and wherein the therapy management component is configured to
request that the patient change the state in response to the detection of the
physiological parameter by vibrating the ambulatory medical device controller
via the tactile stimulator.
51. The ambulatory medical device according to any of claims 35-39, wherein the
therapy management component is configured to delay the administration of
therapy to the patient in response to the detection of the first change in the state
within the first predetermined period by delaying the administration for a time
interval selected based on a severity of the health disorder.
52. The ambulatory medical device according to any of claims 35-39, wherein the
therapy management component is configured to request that the patient change
the states of at least two of the two or more response mechanisms in response to
the detection of the physiological parameter and the identification of the second
mode as the operation mode.
53. The ambulatory medical device according to any of claims 35-39, wherein the
therapy management component is further configured to administer therapy to
the patient in response to detection of no change in the states of the two or more
response mechanisms.
54. A method of delivering therapy to a patient using an ambulatory medical device
configurable between a plurality of operation modes to delay administration of
therapy, the ambulatory medical device including a controller coupled with a
plurality of response mechanisms, each response mechanism of the plurality of
response mechanisms having a state, the method comprising:
identifying, by the ambulatory medical device, an active operation mode from
the plurality of operation modes, the plurality of operation modes including a first
operation mode requiring changes in a state of one of the plurality of response
mechanisms, and a second operation mode requiring changes in states of two of
the plurality of response mechanisms;
detecting, by the ambulatory medical device, a physiological parameter having
value indicative of a health disorder of the patient;
requesting that the patient change the state of one of the plurality of response
mechanisms in response to detecting the physiological parameter and identifying
the first mode as the active operation mode;
monitoring the state of each of the plurality of response mechanisms within a
first predetermined period; and
delaying administration of therapy to the patient in response to detecting a first
change in the state of one of the plurality of response mechanisms within the first
predetermined period and identifying the first mode as the active operation mode.
55. The method according to claim 54, wherein the method further comprises:
requesting, in response to detecting the first change, that the patient change the
state of at least one of the plurality of response mechanisms; and
monitoring the state of each of the plurality of response mechanisms within a
second predetermined period,
wherein delaying the administration of therapy to the patient includes
delaying, in response to detecting the first change in the state within the first
predetermined period and a second change in the state within the second
predetermined period, the administration of therapy to the patient.
56. The method according to claim 54, wherein the ambulatory medical device
includes at least one electrocardiogram (ECG) sensor coupled with the controller
and detecting, by the ambulatory medical device, the physiological parameter
includes detecting an ECG signal.
57. The method according to claim 56, wherein the ambulatory medical device is
configured to deliver at least one defibrillating shock to the patient via at least
one therapy pad coupled with the controller; and wherein delaying the
administration of therapy to the patient in response to detecting the first change
within the first predetermined period includes delaying the delivery of the at least
one defibrillating shock.
58. The method according to claim 56, wherein detecting, by the ambulatory medical
device, the physiological parameter includes monitoring a cardiac rhythm of the
patient via the at least one ECG sensor.
59. The method according to any of claims 54-58, wherein detecting, by the
ambulatory medical device, the physiological parameter having the value
indicative of the health disorder includes detecting physiological parameter
having value indicative of at least one of ventricular tachycardia, ventricular
defibrillation, bradycardia, tachycardia, erratic heart rate, asystole, and pulseless
electrical activity.
60. The method according to any of claims 54-58, wherein the ambulatory medical
device includes a display coupled with the controller; and wherein requesting that
the patient change the state of at least one of the plurality of response
mechanisms in response to detecting the physiological parameter includes
displaying at least one notification to the patient via the display.
61. The method according to claim 60, wherein delaying the administration of
therapy to the patient in response to detecting the first change within the first
predetermined period includes displaying one or more notifications to the patient
via the display.
62. The method according to any of claims 54-58, wherein the ambulatory medical
device includes an audible alert unit coupled with the controller and requesting
that the patient change the state in response to detecting the physiological
parameter includes generating audible alerts to the patient via the audible alert
unit.
63. The method according to claim 62, wherein delaying the administration of
therapy to the patient in response to detecting the first change within the first
predetermined period includes generating audible alerts to the patient via the
audible alert unit.
64. The method according to any of claims 54-58, wherein the ambulatory medical
device includes an accelerometer coupled with the controller and detecting, by
the ambulatory medical device, the physiological parameter further includes
detecting patient motion via the accelerometer.
65. The method according to claim 64, wherein detecting the first change in the state
within the first predetermined period includes increasing the first predetermined
period in response to detecting targeted patient motion.
66. The method according to claim 64, wherein detecting the first change in the state
within the first predetermined period includes decreasing the first predetermined
period in response to detecting a patient fall.
67. The method according to claim 64, wherein delaying the administration of
therapy includes delaying the administration of therapy a first amount of time;
and wherein the method further comprises delaying the administration of therapy
to the patient a second amount of time in response to detecting targeted patient
motion within the first predetermined period.
68. The method according to any of claims 54-58, wherein the ambulatory medical
device includes a tactile stimulator coupled with the controller; and wherein
requesting that the patient change the state in response to detecting the
physiological parameter includes vibrating the ambulatory medical device
controller via the tactile stimulator.
69. The method according to any of claims 54-58, wherein delaying, in response to
detecting the first change within the first predetermined period, the administration
of therapy to the patient includes delaying the administration of therapy for a time
interval selected based on a severity of the health disorder.
70. The method according to any of claims 54-58, wherein the method further
includes administering therapy to the patient in response to detecting no change
in the states of the plurality of response mechanisms.
71. A non-transitory computer readable medium storing executable instructions
configured to instruct at least one controller to perform a method of delivering
therapy according to any of claims 54-58.
72. The method according to claim 54, further comprising providing an alert to the
patient by at least one of glasses and an earpiece, the at least one of the glasses
and the earpiece being communicatively coupled to the ambulatory medical
device.