U.S. patent application number 17/460535 was filed with the patent office on 2021-12-16 for automated external defibrillator systems and methods of use.
This patent application is currently assigned to HeartHero, Inc.. The applicant listed for this patent is HeartHero, Inc.. Invention is credited to Neil D. Blank, James Dotter, David Jon Farrell, James A. Gilbert, Krista Grandey, Gary Montague.
Application Number | 20210387012 17/460535 |
Document ID | / |
Family ID | 1000005811324 |
Filed Date | 2021-12-16 |
United States Patent
Application |
20210387012 |
Kind Code |
A1 |
Montague; Gary ; et
al. |
December 16, 2021 |
AUTOMATED EXTERNAL DEFIBRILLATOR SYSTEMS AND METHODS OF USE
Abstract
The present invention relates to a device, and software and
methodology associated with a portable Automated External
Defibrillator ("AED"). The portable AED works with a mobile device
and software, and includes two or more cardiac pads, a battery
pack, and specialized capacitor. When connected to a patient in
cardiac arrest, the AED contacts Emergency Medical Services, and
records patient information to be transmitted for evaluation by
medical providers. The AED is able to analyze cardiac rhythms,
suggests administering one or more shocks to the patient in
appropriate cardiac arrhythmia, and guides a user on proper CPR
technique, if enabled. The AED software can alert other personnel
via a mobile device app.
Inventors: |
Montague; Gary; (Denver,
CO) ; Farrell; David Jon; (Loveland, CO) ;
Dotter; James; (Boulder, CO) ; Grandey; Krista;
(Denver, CO) ; Gilbert; James A.; (Boulder,
CO) ; Blank; Neil D.; (Eldorado Springs, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HeartHero, Inc. |
Denver |
CO |
US |
|
|
Assignee: |
HeartHero, Inc.
|
Family ID: |
1000005811324 |
Appl. No.: |
17/460535 |
Filed: |
August 30, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15847826 |
Dec 19, 2017 |
11103718 |
|
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17460535 |
|
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62436208 |
Dec 19, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61H 2230/00 20130101;
A61H 2201/0188 20130101; A61H 31/005 20130101; A61H 2201/5043
20130101; A61N 1/3975 20130101; G16H 40/67 20180101; A61N 1/0492
20130101; A61N 1/3987 20130101; A61N 1/046 20130101; A61H 2201/1619
20130101; A61H 31/00 20130101; A61N 1/3993 20130101; A61H 2230/065
20130101; A61H 2201/5071 20130101; A61N 1/39044 20170801; A61H
2201/5084 20130101; G16H 80/00 20180101; G16H 40/63 20180101; A61N
1/3925 20130101 |
International
Class: |
A61N 1/39 20060101
A61N001/39; G16H 80/00 20060101 G16H080/00; G16H 40/63 20060101
G16H040/63; G16H 40/67 20060101 G16H040/67; A61H 31/00 20060101
A61H031/00 |
Claims
1. A compact, automated external defibrillator (AED) system, the
system comprising: an electronics module, including: a power source
comprising at least one CR123 battery; electronic circuitry for
generating, storing, and dispensing electrical charge from the
power source, the electrical charge being suitable for at least one
electrical shock to be applied to a sudden cardiac arrest (SCA)
patient; a display configured to display information; a single
microprocessor for controlling both the electronic circuitry and
the display; and at least two cardiac pads electrically connected
with the electronics module and configured for external attachment
to the SCA patient; wherein the cardiac pads are configured to
transfer the at least one electrical shock from the electronics
module to the SCA patient; and wherein at least one of the cardiac
pads includes at least one sensor, the at least one sensor being
configured for measuring a cardiac rhythm and a body impedance.
2. The system of claim 1, wherein a pulse-width modulation (PWM)
signal from the single microprocessor is adjustable and is
configured to charge the capacitor to a prescribed amount of energy
within 60 seconds.
3. The system of claim 2, wherein the PWM signal is configured to
charge the capacitor to the prescribed amount of energy within 45
seconds.
4. The system of claim 1, wherein a firmware is configured for
automatically adjusting waveform characteristics of the at least
one electrical shock in accordance with the body impedance.
5. The system of claim 1, further comprising an interface for
connecting the electronics module with a mobile communication
device, wherein the interface is in communication with the single
microprocessor.
6. The system of claim 1, wherein the single microprocessor and the
electronic circuitry are configured to start to charge as soon as
the system is turned on.
7. The system of claim 1, wherein the PWM signal from the single
microprocessor is provided to the current charger independent of
any measurement by the at least one sensor.
8. The system of claim 1, wherein the electronics module includes a
current charger and a capacitor.
9. The system of claim 8, wherein the current charger uses a low
current constant charge rate to charge the capacitor.
10. The system of claim 9, wherein the low current constant charge
rate is controlled by a pulse-width modulation (PWM) signal from
the single microprocessor.
11. The system of claim 1, wherein the electronic circuitry
comprises an H-bridge configuration.
12. The system of claim 11, wherein the H-bridge configuration is
configured to generate a biphasic waveform.
13. The system of claim 1, wherein the power source comprises three
CR123 batteries.
14. The system of claim 1, wherein at full charge, the power source
is configured to generate at least six electrical shocks.
15. A compact, automated external defibrillator (AED) system, the
system comprising: an electronics module, including: a power source
comprising at least one CR123 battery; electronic circuitry for
generating, storing, and dispensing electrical charge from the
power source, the electrical charge being suitable for at least one
electrical shock to be applied to a sudden cardiac arrest (SCA)
patient; a display configured to display information; a
microprocessor for controlling at least one of the electronic
circuitry and the display; and at least two cardiac pads
electrically connected with the electronics module and configured
for external attachment to the SCA patient; wherein the cardiac
pads are configured to transfer the at least one electrical shock
from the electronics module to the SCA patient; wherein at least
one of the cardiac pads includes at least one sensor, the sensor
being configured for measuring a cardiac rhythm and a body
impedance; and wherein a pulse-width modulation (PWM) signal from
the microprocessor is adjustable and is configured to charge the
capacitor to a prescribed amount of energy within 60 seconds.
16. The system of claim 15, wherein the PWM signal from the
microprocessor is adjustable to enable charging of the capacitor to
a prescribed amount of energy within 45 seconds.
17. The system of claim 15, wherein the power source comprises
three CR123 batteries.
18. A compact, automated external defibrillator (AED) system, the
system comprising: an electronics module, including: a power
source; electronic circuitry for generating, storing, and
dispensing electrical charge from the power source, the electrical
charge being suitable for at least one electrical shock to be
applied to a sudden cardiac arrest (SCA) patient; a display
configured to display information; a single microprocessor for
controlling both the electronic circuitry and the display; and at
least two cardiac pads electrically connected with the electronics
module and configured for external attachment to the SCA patient;
wherein the cardiac pads are configured to transfer the at least
one electrical shock from the electronics module to the SCA
patient; wherein at least one of the cardiac pads includes at least
one sensor, the sensor being configured for measuring a cardiac
rhythm and a body impedance; and wherein a pulse-width modulation
(PWM) signal from the single microprocessor is adjustable and is
configured to charge the capacitor to a prescribed amount of energy
within 60 seconds.
19. The system of claim 18, wherein the PWM signal is configured to
charge the capacitor to the prescribed amount of energy within 45
seconds.
20. The system of claim 18, wherein the power source comprises
three CR123 batteries.
Description
RELATED APPLICATION
[0001] The present application is a continuation of U.S. patent
application Ser. No. 15/847,826, filed Dec. 19, 2017, which claims
the benefit of U.S. Provisional Patent Application No. 62/436,208,
filed Dec. 19, 2016, both are incorporated herein by reference in
their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to Automated
External Defibrillator (AED) and use thereof.
BACKGROUND OF THE INVENTION
[0003] There are 395,000 Out of Hospital Cardiac Arrests (OHCA)
that occur each year in the United States. Studies have shown that
the use of an Automated External Defibrillator (AED) can increase
the rate of survivability of OHCA by 40%. However, only 2% of OHCA
will occur at a location at which an AED is available. While there
is a big push to increase dissemination of Public Access
Defibrillators (PAD), research has also shown that 80% of OHCA
happen in the home, where the majority of people do not have access
to an AED.
[0004] Additionally, studies have shown that Sudden Cardiac Arrest
(SCA) patients have improved outcomes when the length of time
between incident and shock is reduced. When an AED is not readily
available at the location at which the OHCA occurs, the time from
incident to shock is dependent upon the timely arrival of Emergency
Medical Services (EMS). The national average for time of EMS
arrival is 9 minutes and, during these 9 minutes, the chance of
patient survival decreases by 7-10% every minute. Consequently, SCA
patients are more likely to survive with favorable outcomes if the
EMS response time is within 8 minutes.
[0005] There are three time-sensitive stages of cardiac arrest: 1)
electric phase (up to 4 minutes following cardiac arrest, during
which the heart is most receptive to electrical shock); 2)
circulatory phase (approximately 4 minutes to 10 minutes following
cardiac arrest); and 3) metabolic phase (extending beyond
approximately 10 minutes following cardiac arrest). Studies using
wearable cardioverter defibrillators have shown that addressing
cardiac arrest during the initial electric phase results in a 98%
first time cardioversion success rate. As a result, rapid
administration of an AED treatment to the SCA patient during the
electrical phase has shown success with survival rates as high as
74%.
[0006] Currently, SCA is a leading cause of death among adults over
the age of 40 in the United States and several other countries. In
the U.S. alone, approximately 326,200 people of all ages experience
out-of-hospital non-traumatic SCA each year, and nine out of ten of
these victims die as a result. There are a number of AED solutions
for the defibrillation of the lethal arrhythmias suffered by SCA
patients. While some of these solutions attempt to make the AED
more portable, they fail to meet the needs of the user because they
are still cumbersome and heavy, thus are not truly portable
devices. For example, the lightest AED currently available on the
market is 2.5 pounds, making carrying an AED on-person unlikely.
Other products attempt to assist the bystander by prompting them in
giving quality CPR, although these products still have
shortcomings. Studies show that decreasing the time-to-shock can
greatly increase the chance of patient survival, such that four out
of ten SCA patients survive when bystanders intervene by giving CPR
and using an AED before the arrival of EMS personnel.
Unfortunately, only one-third (32%) of SCA patients receive
bystander CPR, and bystanders treat only 2% of those with AEDs. If
bystanders had a readily available AED that could also shorten the
time to EMS notification, analysis of cardiac rhythm, and delivery
of shock, potentially 100,000 people per year could be saved in the
U.S. alone.
SUMMARY OF THE INVENTION
[0007] In accordance with the embodiments provided herein, there is
provided a method for performing cardiac defibrillation with a
portable automated external defibrillator (AED). The method
includes initiating a cardiac defibrillation program on a control
module communicative with an electrode pad, and detecting a
patient's cardiac rhythm from the electrode pad. The method further
includes connecting the control module to a mobile device,
executing a call with emergency services, gathering geolocation
information, and channeling the call to the emergency services on
an audible speaker. The method also includes prompting a user to
initiate cardiopulmonary resuscitation (CPR) if the cardiac rhythm
is not detected, displaying instructions for CPR on the control
module. The method continues with analyzing the patient's cardiac
rhythm and notifying the user and emergency services when a
shockable cardiac rhythm is detected, and notifying the user to
halt CPR. The method also includes shocking the patient, analyzing
the patient's cardiac rhythm for a normal pulse, and resuming
instructions for CPR if the normal pulse is not detected.
[0008] In another embodiment, a compact, automated external
defibrillator (AED) system is disclosed. The system includes an
electronics module, which in turn includes a power source and
electronic circuitry for generating, storing, and dispensing
electrical charge from the power source, the electrical charge
being suitable for at least one electrical shock to be applied to a
sudden cardiac arrest (SCA) patient. The electronics module also
includes a display for providing guidance to a user of the system,
including instructions on using the system, and firmware for
controlling the electronic circuitry and the display. The system
also includes at least two cardiac pads, electrically connected
with the electronics module and configured for external attachment
to the SCA patient so as to transfer the at least one electrical
shock from the electronics module to the SCA patient, wherein the
power source is a household battery. In an embodiment, the
dimensions of the system is less than approximately 8-inches by
6-inches by 3-inches. In another embodiment, the power source is a
commonly-available household battery, such as a 9V battery or a
plurality of CR123 batteries. In still another embodiment, each of
the cardiac pads includes at least one sensor for measuring a
patient cardiac rhythm and a body impedance of the SCA patient onto
whom the cardiac pads have been attached, and wherein a firmware is
configured for automatically adjusting the waveform characteristics
of the electrical shock in accordance with the measured body
impedance. In yet another embodiment, the system includes a bracket
for housing the electronics module and the cardiac pads when the
system is not in use. The bracket is configured for sensing at
least one of: 1) when the electronics module is removed from the
bracket; 2) when the power source is below a preset minimum power
threshold; and 3) when the system requires servicing.
[0009] In a further embodiment, a method for using a compact AED
system is disclosed. The system includes an electronics module and
at least two cardiac pads housed in a bracket. The method includes
initializing the system by removing the system from the bracket,
contacting emergency medical services (EMS), attaching the cardiac
pads on a sudden cardiac arrest (SCA) patient, and measuring at
least a patient cardiac rhythm and a body impedance of the SCA
patient using sensors included in the cardiac pads. The method
further includes performing an AED administration protocol on the
SCA patient, if so indicated by guidance from the electronics
module, and continuing to monitor the patient cardiac rhythm of the
SCA patient and following additional guidance from the electronics
module until the arrival of EMS personnel.
[0010] While certain embodiments are described in terms of specific
embodiments, it is to be understood that the invention is not
limited to these disclosed embodiments. Many modifications and
other embodiments of the invention will come to mind for those
skilled in the art to which this invention pertains, and which are
intended to be and are covered by both this disclosure and the
appended claims. It is indeed intended that the scope of the
invention should be determined by proper interpretation and
construction of the appended claims and their legal equivalents, as
understood by those of skill in the art, relying upon the
disclosure in this specification and the accompanying drawings.
[0011] Embodiments of the present invention now will be described
more fully hereinafter with reference to the accompanying drawings,
which are intended to be read in conjunction with both this
summary, the detailed description and any preferred and/or
particular embodiments specifically discussed or otherwise
disclosed. The invention may, however, be embodied in many
different forms and should not be construed as limited to the
embodiments set forth herein; rather, these embodiments are
provided by way of illustration only and so that this disclosure
will be thorough, complete and will fully convey the full scope of
the invention to those skilled in the art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1. An automated external defibrillator (AED) module, in
accordance with an embodiment.
[0013] FIG. 2. Internal configuration of a control panel within an
AED module, in accordance with an embodiment.
[0014] FIG. 3. Configuration of the internal components of an AED
control module in certain embodiments.
[0015] FIG. 4. An exploded view of an AED module in certain
embodiments.
[0016] FIG. 5. Configuration of an AED module with control panel
connected to a photo-plethysmography (PPG) monitor, cardiac pads,
and a smartphone/mobile device in certain embodiments.
[0017] FIG. 6A. Electronic configuration of an AED module in
certain embodiments.
[0018] FIG. 6B. Configuration of a PPG monitor in certain
embodiments.
[0019] FIG. 7. Flowchart showing interaction of the user with
embodiments of an application, control module, smartphone, and
emergency services.
[0020] FIG. 8. Flowchart showing interaction of the user with
embodiments of an application, control module, smartphone, and
emergency services.
[0021] FIG. 9. Flowchart showing interaction of the user with
embodiments of an application, control module, smartphone, and
emergency services.
[0022] FIG. 10. A simplified AED Biphasic Truncated Exponential
(BTE) power stage in certain embodiments.
[0023] FIG. 11. A graph showing adjustments made to the shock
waveform based on body impedance, in accordance with an
embodiment.
[0024] FIG. 12. An alternative boost power stage in certain
embodiments.
[0025] FIG. 13. A relational diagram showing the communications
between an AED operations control module and other firmware within
the AED module, in accordance with an embodiment.
[0026] FIG. 14. Flowchart showing the firmware process for AED
standby mode, in accordance with an embodiment.
[0027] FIGS. 15-16. Flowchart showing the firmware process for
administration of a shock protocol, in accordance with an
embodiment.
[0028] FIG. 17. Flowchart showing the firmware process for
monitoring a SCA patient using the AED module, in accordance with
an embodiment.
[0029] FIGS. 18-19. Flowchart showing the firmware process for
managing a shock protocol and generating an electric shock, in
accordance with an embodiment.
[0030] FIG. 20. Configuration of a bracket on which the AED module
is mounted, in accordance with an embodiment.
[0031] FIGS. 21-23. Iso, top, and side views of an exemplary AED
module, in accordance with an embodiment.
[0032] FIG. 24. An exemplary electronics architecture of an AED
module, in accordance with an embodiment.
DETAILED DESCRIPTION
[0033] The present invention seeks to solve the problems described
in the Background by providing an AED device with improved features
over the existing products. For instance, as correct positioning of
the cardiac pads has been correlated with improved survival rates,
it would be desirable for an AED to provide an indication of
whether the cardiac pads have been placed correctly on the SCA
patient. Also, currently available AED devices do not provide an
option to connect to a mobile device that can contact EMS to
initiate a faster response by emergency medical personnel and,
subsequently, earlier hospital arrival. Moreover, currently
available AED devices do not provide a smartphone/mobile device
application for the notification and treatment of suspected cardiac
arrest instances to EMS.
[0034] It would be desirable to have a device that can
significantly improve the outcome of an SCA patient by providing,
even to a non-medically trained person, the ability to detect a
shockable cardiac rhythm and apply a therapeutic electrical shock
to the SCA patient. Therefore, there currently exists a need in the
industry for a truly portable AED and associated methodology that
closes the gap between time of incident, application of CPR, and
delivery of shock.
[0035] To address the aforementioned shortcomings of the existing
art, certain embodiments of the system described herein provides a
compact Automated External Defibrillator and smartphone device
application that assists in the notification of suspected cardiac
arrest to Emergency Medical Services and assists in guiding
bystander CPR and arrhythmia conversion.
[0036] Certain embodiments of the invention further include a
smartphone device with associated application software.
Alternatively, the smartphone device or a control module allows for
cardiac monitoring, vital signs monitoring, defibrillation, and
telecommunications that to enable GPS-specific contact with
emergency services.
[0037] An exemplary embodiment of the AED includes: (1) a
defibrillator including a battery to charge a capacitor to store
and deliver an electric shock; (2) a communication module to
connect the defibrillator to a smartphone/mobile device via wired
or wireless connection; (3) cardiac pads with electrodes to detect
and monitor chest wall compression depth, compression rate, and
chest wall impedance, and heart rhythm; and (4) a smartphone or
mobile device application to analyze information received from the
cardiac pads and recommend appropriate therapy, the application
also having the ability to contact EMS via the smartphone/mobile
device with GPS, Wi-Fi and/or cellular capabilities. In certain
embodiments, these components are connected as follows: a
smartphone with application is connected to the defibrillator via
either a wired or wireless connection, such as Bluetooth or Wi-Fi,
then at least two electrodes with wires ending in cardiac pads
connect from the battery/capacitor pack to the patient's chest.
[0038] Certain embodiments include one or more of the following:
(1) the smartphone application installer resides in the battery
pack and is automatically uploaded to any device connected thereto;
(2) device connects to a smartphone or mobile device via a wired or
wireless connection (e.g., Bluetooth, Wi-Fi), or through a
microphone; (3) the charge for the defibrillating shock is
generated from a replaceable device-centric source (e.g., battery)
or from the internal battery of the smartphone; (4) device includes
a control module, at least one capacitor and application to detect
and deliver any range of electrical shock; (5) the system
components and application detect the impedance of the victim's
chest wall and cardiac pad placement; (6) given impedance
information, the system and application automatically recommends or
configures an electrical charge for the given SCA patient (e.g.,
child or adult); (7) the cardiac pads can be placed anywhere on the
body of the SCA patient; (8) the cardiac pads detect the force of
the CPR compressions on the SCA patient using, for example, a
pressure sensor, impedance detector and/or accelerometer; (9) the
smartphone interfaces with multiple other medical devices via wired
or wireless connections (e.g., Bluetooth or Wi-Fi) or microphone;
(10) the application monitors a variety of sources of data to: A)
refine CPR-related guidance and/or B) bundle the data to be
accessible by first responders; (11) the smartphone interfaces with
other medical devices and detects and monitors vital signs on the
SCA patient including, but not limited to, blood pressure, heart
rate, oxygen saturation, temperature, respiratory rate,
capnography, and electrical cardiac activity; (12) the device has
two or more electrodes (e.g., cardiac pads) that connect to the
patient; (13) the smartphone/device/electrode combination provide a
12-lead electrocardiography (ECG) output; (14) the AED is brand
agnostic with respect to the smartphone or operating system; (15)
the smartphone can be paired via wireless communications or connect
via wire to multiple medical devices simultaneously; (16) the AED
can be connected/paired to multiple smartphones simultaneously and,
if paired, each of these devices can have control over the AED;
(17) the device allows the user to perform cardiac
pacing/synchronized shock from the smartphone device, if the user
has the appropriate knowledge; (18) the smartphone provides a live
video, voice, data or any combination of these feeds to another
medical facility; (19) the smartphone communicates with EMS via an
automated voice annunciation via cellular network, video, SMS or
any other modality by which EMS is able to receive information;
(20) information given to EMS includes, but is not limited to,
current vital signs, CPR results, detectable cardiac rhythm, number
of shocks given, and GPS coordinates/geolocation of events in
progress; (21) such information is generated on a periodic basis
and transmitted to incoming EMS, or generated upon request by EMS
via the application; (22) EMS is able to access the application on
a paired mobile device, facilitating device location and data
requests therefrom; (23) the application allows the control module
to be paired with the information system used by EMS, thus allowing
the remote administration of cardiac shock (e.g., if a child is
using the device for an adult); (24) the device and software
application communicates with cameras of related devices including,
for example, smartphone cameras, Google Glass, or similar products
to allow for direct visualization and display of events and
instructions in progress; (25) the device and software application
guides a user for proper cardiac pad placement; (26) the device and
software application suggest confirmation of no pulse if the
onboard photo-plethysmography (PPG) sensor does not detect a pulse;
(27) the device provides guidance using industry standard for
timing of delivery of shock and CPR; and (28) device automatically
contacts EMS if no call to emergency services is manually initiated
after delivery of first shock.
[0039] Certain embodiments differ from other currently available
devices and solutions because the various embodiments described
herein: (1) provide defibrillation of a cardiac arrest victim with
an empowered smartphone; (2) use batteries that can be purchased
off-the-shelf; (3) include specialized capacitors and circuitry
that generate a therapeutic charge from the off-the-shelf battery;
(4) continuously analyze the cardiac rhythm during CPR; (5) include
sensors in the cardiac pads to detect impedance of the chest wall
and ensure proper pad connection; (6) include additional sensors in
the cardiac pad to monitor compression force, rate and depth of
CPR; (7) by using the sensors to monitor vital signs, ensure that a
cardiac shock is not given at an undesired time; and (8) via the
sensors inside the cardiac pad, communicate information to the
software system regarding size of chest wall which then allows for
recommendation of a therapeutic shock that is correlated with the
size of victim and their individual anatomy, e.g., child or
adult.
[0040] Similarly, the associated method described herein differs
from existing methods in that: (1) the smartphone software
application gives the ability to call emergency services (such as
911 in the United States) and assist the bystander in providing
effective CPR; (2) the smartphone device software application is
able to upload and record data of the resuscitation efforts such
as, but not limited to, vital signs, cardiac rhythm, quality of
CPR, and outcome of electric shock. Certain embodiments also
transmit data to another mobile device in real-time, or after the
fact.
[0041] Certain embodiments of the present invention differ
structurally from other known devices or solutions in that: (1) the
device runs off of readily commercially available consumer
batteries; (2) the device connects to a mobile device and is small
enough for everyday portability; and (3) includes cardiac pads that
can detect force, rate, and depth of compression along with
impedance of chest wall.
[0042] Furthermore, the processes associated with certain
embodiments of the invention differ from known processes and
solutions in that: (1) the device includes a smartphone device
software application initiate communications with EMS; (2) the
software application guides a bystander through quality CPR using
the data obtained from the cardiac pads, such as compression depth,
compression rate, and placement of hands; (3) the device uses the
data to prompt the user if the cardiac pads need to be checked or
re-applied or if the CPR technique needs to be modified; (4)
software application detects the cardiac rhythm during active chest
compression; (5) the software application analyzes cardiac rhythm
and provides electric shock for appropriate cardiac arrhythmias;
and (6) the user will be prompted to stop CPR upon return of
spontaneous circulation (ROSC).
[0043] Among other things, it is an object of certain embodiments
of the present invention to provide an automated external
defibrillator and smartphone device application that assist in the
notification of suspected cardiac arrest to EMS and in guiding
bystander CPR and arrhythmia conversion to overcome the problems or
deficiencies associated with prior solutions.
[0044] It is still further an objective of certain embodiments of
the present invention to create an automated external defibrillator
device that is cost effective, thus increasing the public's access
to AEDs and thereby saving lives.
[0045] Further still, it is an objective of certain embodiments of
the present invention to provide a device that is smaller and more
lightweight than other solutions, thereby enabling the device to be
easily portable. Certain embodiments have a weight of less than one
pound. By making it more portable it increases accessibility, thus
the product will be utilized more frequently, ultimately saving
more lives.
[0046] Further still, it is an objective of certain embodiments of
the present invention to create a device that is able to help
bystanders in a high stress situation to provide proper help in an
efficient manner.
[0047] Certain embodiments of the invention are related to
automated external defibrillator and smartphone device software
application that assist in the notification of suspected cardiac
arrest to EMS and assist in guiding bystander CPR and cardiac
arrhythmia conversion.
[0048] Certain embodiments include: a smartphone/mobile device,
external battery pack/specialized capacitors, at least two cardiac
pads and sensors with associated wires. In an embodiment, these
components are connected as follows: mobile device is connected via
hardwire, Bluetooth or Wi-Fi to a case that holds the battery,
specialized capacitors, and circuitry. The case also holds at least
two cardiac pads with sensors connected via wire, that are in turn
connected to the patient. In an exemplary embodiment, the case
protects the user from the risk of electrical shock, and protects
the internal electronics from electrostatic discharge (ESD), which
can cause the electronics to fail or malfunction in an unsafe way.
Suitable materials for the case includes, for example, a variety of
plastics and other insulating materials.
[0049] Connecting the various components to the mobile device is
done via wire to a connection port on the mobile device or via a
wireless mechanism such as Bluetooth or Wi-Fi. The mobile device
includes software for receiving input via wire or wireless
connection from the case and other vital sign attachments. The
software can recommend initiating a call to emergency services
(e.g., 911). The automated connection via cellular network, video
or SMS to EMS will be able to disclose the location of the AED
being operated. The device and software can automatically send the
patient's information including, but not limited to, vital signs
and cardiac rhythm to the EMS dispatch and/or regional medical
center. The automated system can guide the user regarding correct
depth and rate of compression and be able to advise cardiac shock.
The case holds a portable battery, capacitors, and circuitry to
generate and store at least one electrical charge to produce a
therapeutic charge to cardiovert a patient in cardiac arrhythmia
with the goal of return of spontaneous circulation (ROSC). The
cardiac pads are connected to the to the case via hardwires. The
cardiac pads are able to detect cardiac rhythm when active CPR is
taking place. As an example, the cardiac pads have sensors embedded
that will be able to detect rate and depth of compressions of the
bystander providing CPR. The sensors in the cardiac pads send
information back to the mobile device application for analysis of
shockable versus non-shockable cardiac rhythm. The cardiac pads are
used to deliver the therapeutic shock to the heart. The cardiac
pads detect impedance of the chest to allow the application to
calculate the correct therapeutic electric shock dosage and also
ensure the cardiac pads have the proper connection on the patient
to increase the best chance of cardioverting.
[0050] In certain embodiments, the method includes: identifying a
person, who is the victim of a suspected cardiac arrest; deploying
a portable automated external defibrillator device; connecting the
portable defibrillator device to a mobile using a wired or wireless
connection; automatically initiating the software to prompt the
user to call to EMS by screen button prompt; selecting an option on
the screen of the mobile device to initiate a call to EMS; and
advising EMS of the AED's current location using the mobile
device's internal GPS system and request that help be sent once
connected. In certain embodiments, a user opens cardiac pads and
places them on the victim's chest in either the anterior/posterior
placement or the anterior lateral placement described on a packing
diagram provided on the case of the AED. As soon as the cardiac
pads are placed on the victim's chest, the system attempts to
detect and analyze the cardiac rhythm of the victim. Concurrently,
the software gives voice prompts and a visual display of how to
perform CPR to the user. The software also recommends hand
placement, compression depth, and compression rate for effective
quality CPR, in accordance with American Heart Association
guidelines. As soon as a shockable rhythm is identified, the system
will prompt via voice and video display to halt the CPR to initiate
a shock to the victim. Once shock is delivered, the system will
prompt the user to resume the proper steps of CPR. The device can
also display the patient's vital signs on a screen during the time
the device is deployed. The vital signs and cardiac rhythm can also
be seen by other mobile devices and/or the emergency service
dispatch or regional medical center. If at any time the sensors on
the cardiac pads detect that CPR is not given at the appropriate
rate or compression depth recommended by American Heart Association
(AHA) guidelines (see, for example, "AED Implementation"
(http://cpr.heart.org/AHAECC/CPRAndECC/Programs/AEDlmplementation/UCM_473-
-198_AE D-Implementation.jsp, accessed 18 Dec. 2017)), the software
prompts the user by voice and video image to adjust accordingly.
The sensors also prompt the user if impedance is too high and
recommend checking and/or reattaching the cardiac pads as
necessary. Data regarding the entire event can be monitored and
saved to another device or to the active device for real-time or
subsequent comparative analysis.
[0051] Certain embodiments relate to a device, proprietary software
and methodology associated with the device. With respect to certain
embodiments, the present invention includes a portable
defibrillator that works with a smartphone and software. When
connected to a patient in cardiac arrest, via two or more
electrodes and battery pack/specialized capacitor calls Emergency
Medical Services providing a location. It will record patient
information such as cardiac rhythm and vital signs that can then be
transmitted to an approved facility for evaluation by medical
providers. The device is also able to analyze cardiac rhythms,
suggests administering one or more shocks to the patient in
appropriate cardiac arrhythmia, and instructs bystanders on proper
CPR. The portable defibrillator device and software can alert any
other personnel with the app downloaded in a nearby location for
assistance. This device can be used for any person that is believed
to be in cardiac arrest by bystanders. The components of the
invention include an application for smartphone, a device that is
connected to the smartphone and activates software, the device
includes two or more electrodes with cardiac pads for connection to
a person's chest and to a battery pack and capacitor to provide
electric shocks. In certain embodiments, the configuration
includes: a smartphone which is connected by wire to battery pack
and capacitor which are connected to electrodes that are connected
to cardiac pads that are placed on the chest of the patient.
[0052] With respect to certain embodiments of the device AED
module, it should be further noted that once the device has been
applied to patient and plugged into the smartphone it will activate
the software that will transmit location, vital signs, and cardiac
rhythm to emergency services, it will also analyze placement of the
cardiac pads to ensure proper rhythm analysis and proper CPR via
depth, rate and impedance. Device will recommend administering
electric shock to appropriate and susceptible cardiac arrhythmias.
If the device is used properly and there is a shockable rhythm the
goal is the return of spontaneous circulation (ROSC), activation of
emergency medical services and recording and transmission of data
that occurred during event. With respect to the associated method,
in certain embodiments, the method includes: identifying a patient
that may have cardiac arrest; placing a device and plugging into
smartphone; accessing a smartphone application; following
instructions from device and deliver shock if recommended or
provide CPR if recommended and wait for emergency services to
arrive. Ultimately, at the conclusion of these steps the device
should notify emergency services if cell or Wi-Fi signal allows,
provide instructions for CPR or recommend and deliver cardiac
shock, record vital signs and cardiac rhythm, with the
all-encompassing goal of helping bystanders provide emergent and
adequate care in a life-threatening situation. A portable AED will
lead to improved patient outcomes and more lives being saved.
[0053] Referring to the figures, FIG. 1 shows an automated external
defibrillator (AED) module 10, in accordance with an embodiment. As
seen in FIG. 1, AED module 10 includes a connector 11, an
electronics module 12, at least two electro-conductive cardiac pads
13, and electrical conductors such as wiring 14 connecting cardiac
pads 13 with electronics module 12. Cardiac pads 13 includes
sensors (not shown) for monitoring, for example, cardiac rhythm and
body impedance of the SCA patient to whom cardiac pads 13 are
connected. The sensors in cardiac pads 13 also indicates whether
cardiac pads 13 are properly placed on the SCA patient, and can
indicate to electronics module 12 if one or both of cardiac pads 13
are disconnected from the SCA patient. Furthermore, sensors in
cardiac pads 13 can also include additional capabilities, such as
detection of force, rate, and depth of compression, to help monitor
any cardiopulmonary resuscitation (CPR) performed on the SCA
patient. Connector 11 is attached to electronics module 12 via a
wire 15 in the embodiment shown in FIG. 1. Alternatively, the
connection between the mobile device and electronics module 12 is
established wirelessly through, for instance, Bluetooth or Wi-Fi.
Connector 11 is attached via a receptacle 16 to a mobile device
24.
[0054] While mobile device 24 in FIG. 1 is shown as a smartphone,
it may be another suitable portable device, such as a cellphone, a
tablet, a smart watch, electronic reader, laptop, or the like. A
suitable mobile device has the capability to receive input via, for
example, wired or wireless connections such as Bluetooth, audio,
keyboard, mouse, trackpad, or touch-screen. Additionally, the
mobile device produces an output, such as vibration, camera light,
video display Bluetooth, Wi-Fi, or audio. Internal components of a
suitable device include, for example, a microprocessor, a battery,
GPS, Wi-Fi and/or Bluetooth, an operating system, software readable
media, and storage. When mobile device 24 is connected with AED
module 10, a specialized application software, including features
such cardiac rhythm recognition, patient monitoring, impedance
measurement, and external communication options, is downloaded and
installed on mobile device 24 such that it is able to communicate
with AED module 10.
[0055] AED module 10 connects to receptacle 16 of mobile device 24
via connector 11, in the embodiment shown in FIG. 1. Certain
embodiments include standard connection mechanisms known to those
skilled in the art, such as but not limited to micro USB, Lightning
connector, and USB-C, 30-pin, Thunderbolt, audio, or even
simultaneous connections with multiple inputs of mobile device 24.
Alternatively, AED module 10 connects to mobile device 24
wirelessly (as indicated by symbol 25) via a mechanism such as
Bluetooth, Wi-Fi, or audio. Connector 11 receives and sends signals
from and to electronics module 12, such as communications related
to, for instance, activation of the specialized software
application, the cardiac rhythm analysis, and delivery of a
therapeutic shock.
[0056] In certain embodiments, AED module 10 automatically
activates the specialized software application installed on mobile
device when connector 11 is connected to mobile device 24 via
receptacle 16. For instance, the installed software on mobile
device 24 analyzes the cardiac rhythm from cardiac pads 13 that is
processed/filtered in electronics module 12. Alternatively,
electronics module 12 performs the analysis of data received from
cardiac pads 13 and displays the analysis results on mobile device
24. Electronics module 12 generates and stores an electrical charge
for at least one electrical shock. If electronics module 12 or the
installed software in mobile device 24 deems the patient is
currently undergoing cardiac arrest and can be treated with
defibrillation, a control circuitry (not shown) in electronics
module 12 sends the generated electrical charge to the SCA patient
via cardiac pads 13. Alternatively, shock will be delivered when
the user approves the shock delivery through the specialized
software installed on mobile device 24.
[0057] In an embodiment, each of cardiac pads 13 is configured to
accommodate electrical charge in the form of a biphasic waveform,
as currently recommended by Advanced Cardiovascular Life Support
(ACLS) and American Heart Association (AHA) standards. Cardiac pads
13 can be placed in the standard anterior/lateral position, or can
be placed into the anterior/posterior position, among others.
[0058] In an embodiment, electronics module 12 itself or the
specialized software on the mobile device will analyze the
electrocardiography (ECG) signals received via the sensors in
cardiac pads 13. The analysis determines, for example, whether the
cardiac rhythm measured from the SCA patient is indeed a shockable
rhythm, in accordance with industry standards. Industry standard
shockable rhythms include, for example, ventricular fibrillation
(VF) having an average waveform amplitude greater than 0.2 mV, fine
ventricular fibrillation (FVF) having an amplitude between 0.1 mV
and 0.2 mV, and ventricular tachycardia (VT) of single morphology
(monomorphic VT) or several morphologies (polymorphic VT) (see, for
example, "AED Algorithm Application Note," Philips, 2008
(http://laerdalcdn.blob.core.windows.net/downloads/f2374/AED_algorithm_ap-
-plication_note.pdf accessed 10 Dec. 2017).
[0059] When analysis by electronics module 12 or the software
installed on mobile device 24 determines that the cardiac rhythm
detected is a shockable rhythm, data regarding body impedance is
used to calculate and adjust the appropriate shock waveform to be
delivered via cardiac pads 13 to the SCA patient. For instance, the
energy output from electronics module 12 is adjusted, according to
the body impedance, to produce a waveform according to the accepted
standard biphasic pattern used in modern defibrillators. In certain
embodiments, this voltage waveform is generally between 120-200
Joules in total energy.
[0060] In certain embodiments, the analysis performed by
electronics module 12 or software provides an optional mode in
which rhythms requiring an electrical shock at a smaller/different
electrical output can be identified. An example for such a rhythm
is supraventricular tachycardia (SVT), which requires therapeutic
cardioversion or bradycardia with external electrical cardiac
pacing. In an embodiment, electronics module 12 or software on
mobile device 24 is able to distinguish the need for a synchronized
shock to be delivered on the QRS waves of an ECG reading. Examples
of these rhythms would be supraventricular tachycardia (SVT),
stable ventricular tachycardia, symptomatic atrial fibrillation and
others.
[0061] In certain embodiments, for further data input for the
shockability analysis, additional electrodes can be placed in the
industry standard positions to obtain, for instance, a 12-lead ECG
reading. With this option, the 12-lead ECG data allows better
analytics of the SCA patient's condition, such as the
identification of a ST elevation myocardial infarction (STEMI). For
instance, diagnostic ST elevation in the absence of left
ventricular (LV) hypertrophy or left bundle-branch block (LBBB) is
defined by the European Society of Cardiology/ACCF/AHA/World Heart
Federation Task Force for the Universal Definition of Myocardial
Infarction as new ST elevation at the J point of an ECG reading in
at least 2 contiguous leads of .gtoreq.2 mm (0.2 mV) in men or
.gtoreq.1.5 mm (0.15 mV) in women in leads V2-V3 and/or of
.gtoreq.1 mm (0.1 mV) in other contiguous chest leads or the limb
leads. If such a condition is identified by electronics module 12
or the software installed on mobile device 24, AED module 10
notifies EMS, in an embodiment, thus potentially shortening the
time to cardiac catheterization that is needed for treatment of the
condition.
[0062] In certain embodiments, the specialized software for mobile
device 24 is made available on a software application marketplace
(e.g., the Apple App Store), a specific website on the Internet, or
be uploaded manually. Alternatively, a software installer is stored
on electronics module 12 such that, when a mobile device 24 is
connected, the specialized software is automatically downloaded and
installed on mobile device 24. In certain embodiments, the original
equipment manufacturer will preload the specialized software is
preloaded on electronics module 12. In certain embodiments, the
battery in mobile device 24 can be used to provide power AED module
10.
[0063] Referring to FIG. 2, certain embodiments of the internal
configuration of an AED module or an electronics module 12 is
shown. In certain embodiments, a battery 17 is a 9-volt battery
and, in certain embodiments, can include another off-the-shelf,
household battery including, but not limited to, NiMH, NiCd,
lithium ion, alkaline, silver-oxide, or silver zinc batteries,
singularly or in a combination thereof.
[0064] In certain embodiments, electronics module 12 also includes
a series of capacitors 18 to generate and store a charge for at
least one electrical defibrillation. In certain embodiments,
electronics module 12 also includes a boosting element 19 for
amplifying and filtering the signal received from the cardiac pads.
The signal from the cardiac pads are be received via wires 14,
amplified and filtered at boosting element 19, and sent from a
microprocessor 20 to the software on the mobile device to be
analyzed. Filtering at boosting element 19 reduces electromyography
(EMG) noise and/or electromagnetic interference (EMI) in the
received signal. In an embodiment, boosting element 19 allows
analysis of the cardiac rhythm while active chest compression
(i.e., CPR) is being administered on the SCA patient. In certain
embodiments, microprocessor 20 stores downloaded software from the
manufacturer to be uploaded to mobile device 24, in the event the
software is not already installed on the device.
[0065] Electronics module 12 also receives from and transmits to
mobile device 24 any information via wireless arrangements, such as
Bluetooth and Wi-Fi using a transmitter 21. In certain embodiments,
a port 22 is provided on electronics module 12 to accept additional
electrodes, such as vital sign devices 23 including, but not
limited to, capnography, blood pressure, pulse oximetry, and
glucose monitors, smart watches, and Google Glass. Software
applications equivalent to vital sign devices 23 could also be
installed on electronics module 12 or mobile device 24 using
wireless connections, such as Bluetooth, Wi-Fi, or audio, or a
wired connection.
[0066] In certain embodiments, a portable AED module 30 as shown in
FIG. 3 is connected to mobile device 24 via wire 15. Components of
AED module 30 are placed in or on a housing 31. Certain embodiments
include a plurality of indicators 32 that visually show a user the
steps for resuscitating a person affected with a cardiac episode.
Still referring to FIG. 3, in one example, the indicators include,
for example, a Heart Analysis indicator 32a, a Place AED/CPR Pad
indicator 32b, a Perform CPR indicator 32c, a Clear indicator 32d,
a Warning Shock indicator 32e, and a Remove Pads indicator 32f
Indicators 32 are mounted on an upper cover 41, in an embodiment.
It will be appreciated by those skilled in the art that the
indicators found on an AED module is not limited to these indicator
types, and may include greater than or fewer than these indicator
types.
[0067] In certain embodiments, indicators 32 are illuminated to
allow a user to visually verify the steps for performing
defibrillation/CPR on a SCA patient. For example, indicators 32 are
translucent, and illuminated by lights 38a found on an indicator
board 39, as shown in FIG. 4. In certain embodiments, a display 34
provides further information. For example, a display 34 may be an
LCD, VFD, OLED, analog, or other display to provide information. In
certain embodiments, display 34 provides user feedback, status
information, or other information relevant to the process of
defibrillation or CPR. In certain embodiments, display 34 provides
heart rate information. In certain embodiments, display 34 forms a
part of indicator board 39.
[0068] Again referring to FIG. 3, in certain embodiments, an
interface 33 includes speakers that transmit audio cues for using
the AED and/or administering CPR. In certain embodiments, a user
listens to the audio cues from interface 33 and follows the
instructions of the audio cues. The speakers can transmit other
information including, but not limited to, GPS location, real-time
conversation with EMS personnel, instructions for use, among
others. In certain embodiments, interface 33 further includes a
battery life indicator.
[0069] Still referring to FIGS. 3 and 4, certain embodiments of
portable AED module 30 includes a housing bezel 40. Housing bezel
40 is translucent as to allow light from lights 38b to pass
through. Lights 38b are mounted on an AED power board 43 and
illuminate an area 35 through housing bezel 40 to provide further
visual information to assist a user while in the process of
performing defibrillation and/or CPR. Illumination can occur
outside of area 35 as well. It will be appreciated that lights 38a
and 38b can be one or more colors as to provide color-specific
information provided by any number of light sources, such as light
emitting diodes (LEDs), incandescent lighting, or fluorescent
lighting.
[0070] Referring to FIG. 4, in certain embodiments, an AED power
board 43 includes a bulk charge storage array 44 as to hold an
electrical charge. In certain embodiments, battery 17 connected
with AED power board 43 provides AED module 30 the charge necessary
for defibrillation. Alternatively, other power sources, such as the
battery within mobile device 24 can be used. In certain
embodiments, an insulation 45 provides isolation of circuitry
between indicator board 39 and AED power board 43. Additionally, a
back cover 42 encloses a portion of housing 31. In certain
embodiments, back cover 42 may be removable as to allow a user to
replace battery 17.
[0071] Referring to FIGS. 3 and 5, certain embodiments of AED
module 30 is further connected to other components. For example,
AED module 30 is connectable via wires 15, 36, 37 to a mobile
device 24, photoplethysmography (PPG) monitor 46, and a plurality
of pads 47. For example, PPG monitor 46 attaches to an earlobe or
finger to detect, vital signs such as blood flow, heart rate, a
viable heart rhythm, and blood oxygen saturation (02%). In certain
embodiments, PPG monitor 46 detecting no pulse triggers AED module
30 to direct the user to start administration of CPR.
[0072] Pads 47 include, for example, a CPR coaching pad 48 in
addition to cardiac pads 13. In certain embodiments, CPR coaching
pad 48 includes or is connected with sensors such as accelerometer,
pressure sensor, impedance sensor, and optionally to outputs such
as speakers, light indicators, and others, as shown in FIG. 6A. An
accelerometer measures the movement of the pad, and a pressure
sensor measures the active force and release of CPR compressions.
Thus, CPR coaching pad 48 directs the user on proper administration
of CPR on the patients, including directives to go faster, harder,
or to stop compressions. An example of CPR coaching pad 48 is shown
in FIG. 6B. Sensors in CPR coaching pad 48 receives CPR data as a
user is performing CPR, and generates real-time feedback to adjust
the CPR accordingly so that industry standard timing of CPR and
delivery of shock are performed.
[0073] Certain embodiments of cardiac pads 13 include sensors
therein to detect data from the SCA patient such as, but not
limited to, body impedance and ECG signals. In certain embodiments,
each of cardiac pads 13 include an area 49 that
visually/graphically indicates correct placement of such pad on the
patient's body.
[0074] Continuing to refer to FIG. 6A and FIG. 6B, fat black arrows
indicate AED output to cardiac pads 13, fat open arrows indicate
analog data transfer, and solid arrows indicate digital data
transfer. Data from PPG monitor 46, CPR coaching pad 48, and
cardiac pads 13 are gathered and processed by a safety processor
50. Once a determination is made that defibrillation is appropriate
in a given situation, safety processor 50 communicates with an AED
power and waveform module 51 and a switch and isolation module 52
to initiate and deliver an electric shock to cardiac pads 13. In
certain embodiments, safety processor 50 communicates with mobile
device 24 through an interface module 53, such as a lightning or
USB connector. Information regarding the patient status,
defibrillation instructions, CPR instructions, emergency services
communication, and others described herein are communicated from
the safety processor 50 to the interface modules 53 using visual
and audio cues, such as via a user interface (UI) speaker 54 and a
UI display 55. Safety processor also communicates with a battery
and power supervision module 56.
[0075] In certain embodiments, portable AED module 30 can be used
as a stand-alone device, without connection to a mobile device.
When used alone, AED module 30 provides, for example, three
electric shocks with a biphasic waveform, each shock with a charge
level suitable for therapeutic use and a delivery time of 1 minute
or better at an ambient temperature of 0.degree. C. from one
standard household battery or battery pack, such as a 9V battery.
For instance, AED module 30 starts to charge as soon as AED module
30 is powered on. In certain embodiments, delivery of the shock
occurs within 1 minute of starting the charging sequence, after
detection of an appropriate shockable cardiac rhythm. LED icons or
indicators 32 located on AED module 30 prompts the user visually
and with audible prompts to guide the user through the appropriate
steps of setting up AED module 30 for defibrillation, according to
industry-recommended standards. In some cases, AED module 30
directs the user to initiate CPR, if no pulse is detected from a
PPG monitor, which can be provided as part of AED module 30, and if
no pulse confirmed by the user. In such a case, certain embodiments
of AED module 30 provide real time CPR guidance with feedback, as
previously discussed. In certain embodiments, pressure sensors in
AED coaching pad 48 monitor patient chest recoil during CPR
administration. In certain embodiments, AED module 30 coaches the
user through the proper rate and depth of CPR using an impedance
sensor and accelerometer. For instance, an XYZ accelerometer, used
to measure acceleration and movement of AED coaching pad 48, and a
pressure sensor membrane, used to measure active force and release
of each CPR compression, send CPR-related data to AED module 30 via
a connector (such as wire 36) to provide user feedback regarding
the effectiveness of the CPR efforts, in accordance with an
embodiment. AED coaching pad 48 includes, for example, an upper
layer stiffener, accelerometer, flex circuit, pressure sensor
membrane, and bottom layer stiffener with adhesive, in the
embodiment shown in FIG. 6B. In certain embodiments, the guidance
provided in the use of AED module 30 adheres to guidelines set
forth by industry standard organizations, such as the American
Heart Association (AHA) for steps in addressing cardiac arrest.
[0076] When an AED module is used with mobile device 24, the above
features, as well as additional features can be provided. In
certain embodiments, AED module 30 receives geolocation data from
mobile device 24. When AED module 30 is connected with mobile
device 24, a software application is automatically opened. The
communication capabilities of mobile device 24 can be used to
contact EMS (such as "911" in the U.S.) and provide location data
to a dispatcher that receives the communication. In an embodiment,
a Short Message Service (SMS) message is sent to EMS on current
status of the SCA patient, and continue to update EMS of any
changes to the SCA patient's condition. Information delivered to
EMS includes, but not limited to, details of any shock provided,
return of spontaneous circulation (ROSC), current heart rate, pulse
oximeter readings, and cardiac rhythm status. Providing this
information will give EMS or the hospital the ability to better
prepare for needed intervention in care of the specific SCA
patient.
[0077] FIGS. 7-9 show the steps involved in using a portable AED
module, in accordance with an embodiment. Certain embodiments
include initiating an application; the application asking if there
is an emergency situation; requesting to call emergency services;
providing location to EMS via an automated voice over the device
and via text message; automatically placing the open call to the
emergency services on speakerphone; placing a PPG monitor;
suggesting that CPR should begin if no pulse is detected; checking
for pulse confirmation; providing a prompt via audio and visual
displays on a screen to ensure effective compression is being
performed; determining a person providing CPR is fatigued;
recommending to change provider if low quality CPR is being
performed; notifying when analyzing rhythm while CPR is in
progress; notifying a person performing CPR and EMS via the
speakerphone that a shockable/non-shockable rhythm is detected;
notifying that victim is able to be shocked and advising to stop
CPR and not to touch the patient; resuming CPR; recommending
checking for pulse and responsiveness if PPG monitor detects a
pulse and if a viable rhythm is detected; placing the patient in a
recovery position displayed on the screen; and continuing to
monitor the patient. In certain embodiments, an AED module includes
other components, including but not limited to a GPS tracker,
mobile phone services, modem, and Wi-Fi to communicate with
emergency services.
[0078] Referring to FIG. 10, an exemplary circuitry for generating
a charge for defibrillation. In certain embodiments, a simplified
AED Biphasic Truncated Exponential (BTE) power stage is an
energy-based, two stage design having a constant current boost
charger (e.g., a SEPIC multiplied boost charger) supplying a bulk
energy storage capacitor, followed by a high voltage full-bridge
for steering the positive- and negative-half phases. FIG. 12 shows
an alternative embodiments of an alternative AED module, which
includes a tapped inductor boost charger along with full-bridge
steering. In an example, high-voltage and current-sensing feedback
are provided to the microprocessor to prevent incorrect dosing and
detect error conditions. Low-voltage ECG sensing stages are
isolated by relays to prevent overvoltage damage during shock
delivery. The current charger uses a low current constant charge
rate (in the milliamp range) controlled by pulse-width modulation
(PWM) signals from the microprocessor to charge the energy storage
capacitor to the prescribed amount of energy within 60 seconds or
less. In an example embodiment, a charge time of approximately 45
seconds or less has been achieved using four CR123 batteries as the
power source. This length of time and level of charging current is
such that a standard 9V alkaline battery can be used to meet the
goal operating time of several hours with at least 6 fully rated
shocks at full battery conditions and three shocks and 15 minutes
of operating time at minimum indicated battery level prior to AED
use. The output current is steered through the positive and
negative phases using, for instance, a high-voltage full-bridge
performing hard switching of the 10-20 ms total duration pulses.
The phase transitions times are determined based on the body
impedance (from 50 ohms to 150 ohms), as seen for example in FIG.
11. That is, by adjusting the timing and amplitude of the positive
and negative phases, the total energy of the shock applied to the
SCA patient can be modified for the specific patient. In an
exemplary embodiment, the body impedance is measured using the
existing wiring of the cardiac pads by sending a low voltage square
wave across the cardiac pads and calculating the load between the
cardiac pads detected when the polarity of the square wave is
reversed.
[0079] In the example shown in FIG. 11, the waveforms correspond to
different transition times and amplitudes calculated for different
body impedance values, in accordance with an embodiment. The total
energy applied to the SCA patient per shock can be calculated using
the following Eq. 1:
E=.intg.*i % R dt [Eq. 1]
where [0080] i=V/R=current, R=body impedance, and t=time. In FIG.
11, a waveform 1110 corresponds to R=50 ohms, a waveform 1120
corresponds to R=75 ohms, and a waveform 1130 corresponds to R=125
ohms. For instance, as shown, an energy peak of 200 J for body
impedance of 50 ohms corresponds to a current of i=-40 Amps. For
the example of a charge provided by a 120 microfarad capacitor
holding a charge of 1640V, the switching and end times (t.sub.2 and
t.sub.3 in FIG. 11) are summarized in TABLE 1.
TABLE-US-00001 [0080] TABLE 1 Switch time t2 End time t3 Body
impedance (ohms) (milliseconds) (milliseconds) 25 1.38 4 50 2.76 8
75 4.13 12 150 8.27 24 200 11.02 32
[0081] It is important to note that the embodiments described
herein require innovative solutions to problems not faced by
previously available AEDs For instance, the embodiments described
herein provide:
[0082] 1. A highly portable AED with a form factor that is much
smaller (e.g., the circuit boards fit within 6-inches by 6-inches
by 2-inches in certain embodiments) than that of the
commercially-available AEDs;
[0083] 2. Circuitry for generating industry-standard biphasic shock
from consumer batteries that are readily available to ordinary
users;
[0084] 3. The AED being ready to deliver the generated charge to
the patient within the FDA-required time frame; and
[0085] 4. Optionally, the ability for the AED to connect with a
mobile device for communication with emergency medical services
personnel. These are requirements that go beyond those that have
been faced by previous AED manufacturers.
[0086] It is particularly emphasized that, in order to achieve the
necessary performance from a compact, portable AED from a household
battery, the coordination of the electronic design and firmware is
important. It is particularly emphasized that the generation of
shock, and the regulation thereof, powered by a
commercially-available household battery and presented in a
user-friendly, compact package at an affordable price point is a
significant engineering achievement. There are considerable
challenges in reducing the package size of the AED, especially with
the various voltage converters and high voltage drivers involved in
generating the therapeutic shock according to best practices from a
household battery. In particular, considerable engineering
ingenuity is required to achieve the necessary performance under
the above listed limitations, particularly as the operation of the
high voltage device by an untrained user involves extensive
consideration of safety measures provided in the physical features
as well as the logic involved in the firmware and ease of use in
the user interface. No device equivalent to the embodiments
described herein is currently known.
[0087] The generation of the biphasic waveform from common
household batteries, such as one or more 9V or CR123 batteries, is
a significant challenge due to the limited voltage and current
provided by such batteries. The circuitry required to generate an
adjustable biphasic waveform, such as those illustrated in FIG. 11,
from household batteries while fitting within a highly portable
package is a unique challenge solved in the embodiments described
herein.
[0088] For instance, focusing on the H Bridge shown as "Full-bridge
Steering" in FIG. 10, the method used to generate the biphasic
waveform in certain embodiments described herein is different from
existing designs, such as those that separately generate the
positive and negative phases then combines them using a time delay
circuit when administering to the patient. In an exemplary
embodiment, the biphasic waveform is generated by discharging a
single high voltage capacitor using an H Bridge configuration under
microprocessor control.
[0089] More specifically, in an exemplary embodiment shown in FIG.
10, switches M4 and M3 are closed, then opened. Subsequently,
switches M5 and M2 are closed, then opened. Software is used to
determine the appropriate timing of each phase to deliver a total
charge of, for instance, 150 J in accordance with Eq. 1 above, with
equal charge in each direction of the decaying resistor-capacitor
(RC) potential for each phase (i.e., M4-M3 combination, then M5-M2
combination). This exemplary H Bridge configuration allows certain
embodiments to generate the required biphasic waveform using only
one charge reservoir, thus delivering all of the required charge
from the one charge reservoir for both polarities. Furthermore,
firmware logic is used to prevent erroneous control of the H Bridge
(e.g., combinations such as M4-M2 and M5-M3 for the components
shown in FIG. 10). An H Bridge board, such as IXYS H-bridge driver
board, is an example of a board that can be configured as disclosed
herein. Additional potential candidates for use in the H Bridge
configuration are, for example, Powerex modules and Isolated Gate
Bi-polar Transistors (IGBTs), Texas Instruments modules and IGBTs,
Infineon PCB modules, CT-Concept/Technologies Power Integrations,
IXYS drivers and IGBTs, and others suitable equivalents.
[0090] Another point of innovation for certain embodiments
described herein is the DC-DC converter implementation shown, for
example, in FIG. 10 and FIG. 12, capable of enabling capacitor
charging within one minute, or as little as less than 30 seconds.
In an example, the high voltage DC-DC converter uses a flyback
transformer with a forward diode topology. Multiples of such DC-DC
converters can be placed in parallel using diode ORing to reduce
the charge time, with a trade-off of increasing the current draw
from the battery. In an example, the power that can be generated
from a 9V at 1 A is 9 W. If an energy output of 200 Joules, which
is equivalent to 200 W*seconds, then this level of energy output
can be obtained in 200 W*seconds/9 W=22 seconds at 100% battery
efficiency. Efficiency may be less, which could increase the charge
time.
[0091] Alternatively, three or four CR123 batteries, which are also
readily available with nominal voltage of 3.0V each, may be used in
place of the 9V battery to supply sufficient charge within the
required time frame. In an exemplary embodiment, the circuit design
is based upon the use of a 9V operating at a current of 1 A, which
can be achieved with parallel or series combinations of batteries.
For instance, parallel combinations of N 9V batteries will require
diode ORing and will supply 1/N current capability for each. Series
combinations will require each battery to be 1/N of 9V and to
deliver the full 1 A. CR123 batteries (for example, Energizer
Lithium/Manganese Dioxide EL123 AP batteries
(http://data.energizer.com/pdfs/123.pdf)) can deliver 3V at a
continuous current of 1.5 A, and therefore three such CR123
batteries in series would meet the criteria.
[0092] In certain embodiments, a further variation for the high
voltage DC-DC converter is used in order to more efficiently
produce the required biphasic waveform within the FDA-required
charge time. This variation is based on the knowledge that lower
voltage DC-DC converters can produce higher current output than
higher voltage DC-DC converters because converters are usually
designed to put out a fixed amount of power. While a single
off-the-shelf DC-DC converter does not provide a sufficiently short
charge time, a multi-tier approach can be used by diode ORing the
output of multiple DC-DC converters with different voltage
capacities.
[0093] For example, different variants of off-the-shelf DC-DC
converters can be tiered to yield outputs stepped from 2000V to
4000V from a 12V input. If a 9V input is connected to the same
configuration, outputs would step from 1500V to 3000V.
[0094] This diode ORing concept for faster charging utilizes the
lower voltage converter to deliver higher charging current up to
1500V, and then one or more of the higher voltage converters to
bring the voltage up to the final desired value. In other words,
rather than using a single, or even two, high voltage DC-DC
converter, faster charging can be achieved by using a combination
of lower voltage and higher voltage DC-DC converters in a tiered
configuration. A combination of high voltage DC-DC converters, such
as EMCO HV DC-DC converters American Power Designs, and LinearTech
DC-DC converters with custom transformer and circuit topologies,
can be used to implement the embodiments as disclosed herein.
[0095] In certain embodiments, the firmware merges control logic
for the circuitry, as well as impedance measurement across the
cardiac pads (i.e., the impedance related to the patient's size) in
order to adjust the parameters of the applied biphasic waveform to
the specific patient. As an example, the microcontroller unit (MCU)
within the AED serves to provide overall control of the performance
of the AED in a variety of ways.
[0096] In an embodiment, the MCU has several responsibilities in
the fully functional AED. For instance, the MCU:
[0097] 1. Delivers a shock as a biphasic waveform with a precise
shape, according to precise timing specifications.
[0098] 2. Monitors an ECG signal, sensed from the cardiac pads, and
to differentiate between "shockable" rhythms and "unshockable"
patterns. The associated algorithm runs internally within the AED
without real-time access to the cloud, or to any attached device
such as a smartphone. Such an algorithm is defined, in the present
disclosure, as a shock indicator algorithm (SIA). The specific
conditions identified required for differentiation between
shockable and unshockable cardiac rhythms by the SIA follow
guidance from industry organizations, such as the recommendation of
ACLS and AHA. In an embodiment, the SIA is prioritized above other
processing activities within the AED such that the SIA interrupts
any other activities in the MCU to commence the shock protocol, to
the exclusion of other activities. Further details regarding the
SIA are provided hereinafter at the appropriate juncture.
[0099] 3. Guides users through the shock protocol, such as by
displaying instructions to stand clear, allowing the required
amount of time for rescuers to comply with those instructions, and
finally triggering the shock itself.
[0100] 4. Monitors physiological signals pertinent to the
determination of whether to perform CPR.
[0101] 5. Monitors the performance of a person administering CPR,
including sensor measurements related to the CPR itself as well as
physiological data from the patient, so as to provide guidance to
even a lay person without CPR training.
[0102] 6. Connects and communicates with a smart phone, via a wired
or wireless connection, for enhanced features such as AED and CPR
guidance, and communication with emergency medical services
personnel.
[0103] 7. Controls certain AED hardware components such as, for
example, controlling a charging sequence in preparation for
administering a shock.
[0104] 8. Detects the attachment status of the cardiac pads to the
SCA patient such that, in the case the cardiac pads are not
well-attached to the SCA patient, for example, the AED alerts the
user to the condition.
[0105] The activities in the above list need not happen
simultaneously. For example, the device can progress through a
charging sequence (item 7 above), while providing ECG signal input
to the SIA (item 2 above) and also monitoring the patient for other
physiological signs useful to the administration of CPR (item 4
above), as well as monitoring the user's CPR performance (item 5
above).
[0106] If the SIA indicates that a shock is needed, the MCU
continues with the timed charging sequence (item 7 above), if not
yet completed, while simultaneously guiding the user through the
shock protocol (item 3 above) and possibly continuing to monitor
physiological signs (item 4 above). In an exemplary embodiment, the
MCU contains logic such that the administration of a shock is only
commenced when certain criteria are fulfilled. For example, the MCU
can be set such that shock is administered only when: 1) a shock
sequence was initiated by the user; 2) the charging sequence has
been completed; and 3) the shock protocol has been completed with
no alerts, such as due to displaced cardiac pads.
[0107] As another example, during the actual administering of a
shock, the MCU turns off all other AED activities not essential to
that primary function to avoid conflicts and to protect sensitive
components. Additionally, after a shock has been administered, the
MCU resets some of those other activities to a new-start state, as
data gathered prior to the shock may be no longer relevant or
accurate.
[0108] In an exemplary embodiment, the MCU has several tasks
related to the shocking function, including:
[0109] 1. Monitoring vital signs of the SCA patient and engaging
the SIA to look for a shockable pattern;
[0110] 2. Guiding the user through the shocking protocol;
[0111] 3. Managing the charging sequence; and
[0112] 4. Controlling the shock waveform produced by the AED
circuitry.
[0113] More specifically, in an embodiment, the MCU provides
guidance to the user, such as to "stand back" or "stay clear" in
anticipation of the shock administration, including a protocol to
allow the user sufficient time to comply before administering the
shock. The MCU can also provide logic to combine information about,
for example, the placement of the cardiac pads on the SCA patient,
the readiness state of the hardware (e.g., capacitor charged), and
the analysis by the SIA and, if all of the requirements are
satisfied, instruct the user to stand clear and, after a reasonable
time, commence the shock.
[0114] In an embodiment, the MCU manages specific timing aspects of
the generation of the biphasic waveform produced by the AED. For
example, the MCU manages a sequence of several carefully timed
processes that, once initiated, progress through all the steps in a
prescribed order, all the way to completion without interruption.
In an exemplary embodiment, the state machine within the MCU
firmware administers the setting of the timers of various
durations, and uses these timers to drive the output pins to
control the AED hardware. For instance, the state machine includes
eight unique states with timing on the order of milliseconds with a
timing precision of 100 microseconds.
[0115] In an example, several events are required before a shock is
administered. These include:
[0116] 1. A "shock needed" signal from the SIA (i.e., a shock
request);
[0117] 2. Completion of guidance sequence, alerting the user to
stand back and away from the SCA patient; and
[0118] 3. Indication from the circuitry hardware that the charging
function has been completed.
[0119] These required events happen asynchronously with respect to
each other. For example, the shock request can immediately trigger
the user alert operation, or the charging sequence can be set to
begin as soon as the AED unit is turned on, such that this step has
no direct connection with the shock request from the SIA.
Additionally, the MCU can include features such as, but not limited
to:
[0120] 1. The charging sequence completed (e.g., "HV_Ready") is a
hardware interrupt, via an Interrupt Service Routine (ISR);
[0121] 2. The shock request is a message from one part of the
firmware to another, or from a separate hardware component, if that
solution is provided onboard a processor chip or the like; and
[0122] 3. The actions to alert the user (e.g., via flashing lights
and/or audio alerts) are managed by a clock in the firmware.
[0123] As an example, the main loop of the firmware contains the
logic to check that a shock is required, and that the protocol
prior to administering the shock (e.g., the user has been alerted
to "stand back," the capacitors are fully charged) has been
completed, and then automatically administer the shock. The
firmware main loop managers, for instance: 1) charging requests; 2)
shock requests; 3) discharge request to safe state (e.g., if the
shock protocol has been aborted); and 4) battery test requests.
Such requests can be presented to the firmware as buttons or as
terminal commands. For instance, as buttons, the requests arrive in
ISRs where minimal logic is allowed (e.g., no terminal output). In
an example, buttons and terminal requests behave the same way;
i.e., instead of direct action, the request is registered in a
state variable that the main loop will check on its next iteration.
Such a configuration safely allows for feedback to developers via
the terminal, while still allowing the ISRs to exit quickly if
necessary.
[0124] An example process flow of a firmware controlling the AED,
in accordance with an embodiment, is described in FIGS. 13-19.
[0125] Referring first to FIG. 13, a relational diagram shows the
communications between an AED operations control module and other
firmware within the AED module, in accordance with an embodiment.
As shown in FIG. 13, an AED operations control module (Ops Ctrl)
1305 includes circuitry and logic to orchestrate the overall
operation of the AED module, such as AED module 10 of FIG. 1. Ops
Ctrl 1305 is in communications a standby power usage management and
monitoring module (Stdby) 1310, which manages the operations of the
AED module when in standby mode. Stdby 1310 includes circuitry and
logic to maintain, for example, a microprocessor and related
circuitry in a low-power mode to facilitate a longer shelf life for
the battery systems within the AED module. When the user activates
the AED module for treatment use, Stdby 1310 sends Ops Ctrl 1305 a
signal 1312 to commence the treatment operation of the AED
module.
[0126] In an embodiment, Stdby 1310 communicates with a charging
voltage battery test module (Charge BTM) 1315, which includes
circuitry and logic to test the battery capacity status of the
battery, which powers the shock generation for the AED module.
Periodically, Stdby 1310 instructs charge BTM 1315 to check the
battery capacity of the main battery in the AED module, then send
an indication via main battery status channel 1316 back to Stdby
1310.
[0127] In an exemplary embodiment, Stdby 1310 is also connected
with a control voltage battery test module (Control BTM) 1320,
which tests a control battery for powering a microprocessor and
related control circuits. Periodically, Stdby 1310 instructs
Control BTM 1320 via a control battery status channel 1322 to test
the capacity of the control battery, then send an indication back
to Stdby 1310.
[0128] Additionally, in an embodiment, Stdby 1310 communicates with
a user notification module (UI) 1325, which includes circuitry and
logic to manage the conveyance of information to a user regarding
device maintenance, as well as during AED operation. For instance,
if either a signal from main battery status channel 1316 or control
battery status channel 1322 indicates that the charge of the
respective battery is low and requires replacement or maintenance,
Stdby 1310 sends a status alert signal 1327 to UI 1325 to display
an alert indication to notify a user of the problem. UI 1325 also
is in direct communications with Ops Ctrl 1305 via a UI
communication channel 1329 to display user guidance or alerts
during the operations of the AED module, as will be explained in
detailed as the appropriate juncture below.
[0129] Continuing to refer to FIG. 13, in an exemplary embodiment,
Ops Ctrl 1305 is connected with a pads placement monitoring module
(Pads Mon) 1330, which includes circuitry and logic to monitor
whether a user has properly attached a pair of cardiac pads onto
the SCA patient. Upon initiation of the AED operations, and after
Ops Ctrl 1305 prompts the user to place the cardiac pads on the SCA
patient via UI communication channel 1329 to UI 1325, Ops Ctrl 1305
checks with Pads Mon 1330 via a to ensure the cardiac pads have
indeed been properly attached via a pad status channel 1332.
Additionally, Pads Mon 1330 can communicate with Ops Ctrl 1305 on
an asynchronous basis (indicated by a dashed arrow 1334) to alert
Ops Ctrl 1305 in case, for example, if a cardiac pad becomes
detached from the SCA patient.
[0130] Still referring to FIG. 13, Ops Ctrl 1305 is also in
communication with a multiple shock protocol management module
(Multi-Shock) 1335 via a multi-shock channel 1337, in an
embodiment. Multi-Shock 1335 includes logic to manage situational
behavior of the AED in cases where the initial shock does not
result in a return to normal sinus rhythm for the SCA patient. Ops
Ctrl 1305 also communicates with an event recording module 1340 via
an event recording channel 1342. In an embodiment, event recording
module 1340 includes circuitry and logic to manage the capture of
data related to, for instance, the condition of the SCA patient,
therapeutic efforts by the AED, and external communications
records.
[0131] In an exemplary embodiment, Ops Ctrl 1305 manages a
charge/discharge management and monitoring module (Charge Mod)
1345. Charge Mod 1345 includes circuitry and logic to manage the
charging of the capacitor for storing the charge to a correct level
in order to administer a therapeutic shock. Charge Mod 1345 also
includes circuitry and logic to manage the discharge of the
capacitor in the event that a therapeutic shock is not required,
such that the AED can be handled safely and returned to storage in
a safe state. Charge Mod 1345 communicates with Ops Ctrl 1305 via a
charge management channel 1347 to receive and acknowledge, for
example, a charge or a discharge command. Also, Charge Mod 1345 can
asynchronously communicate its status to Ops Ctrl 1305 (as
indicated by a dashed arrow 1349), such as to indicate the
capacitor charge has been reduced to a safe handling level sometime
after a discharge command has been received from Ops Ctrl 1305.
[0132] In an embodiment, Ops Ctrl 1305 also controls a subject
monitoring/shockability decision module (Subject Mon) 1350,
including the SIA. Subject Mon 1350 includes circuitry and logic to
manage the gathering of physiological measurements, such as cardiac
rhythm, body impedance, and/or ECG signal. Subject Mon 1350 also
includes circuitry and logic to analyze the collected data to
determine whether the SCA patient's condition is one that requires
or can benefit from a defibrillating shock. Ops Ctrl 1305 issues
requests to Subject Mon 1350 to determine shockability of the SCA
patient via a subject monitoring channel 1352. Whenever a
determination of the shockability of the SCA patient has been made,
sometime after receipt of the request for shockability
determination from Ops Ctrl 1305, Subject Mon 1350 send an
indicator back to Ops Ctrl 1305 via an asynchronous communication
(indicated by a dashed arrow 1354). Finally, Ops Ctrl 1305 also
controls a shock control module (Shock Ctrl) 1355 via a shock
control channel 1357. In an embodiment, Shock Ctrl 1355 includes
circuitry and logic to manage the determination of the shock
waveform parameters, such as the durations of the positive and
negative components to a biphasic shock, based on analysis of
physiological measurements such as body impedance. Shock Ctrl 1355
further includes, in an embodiment, circuitry and logic to produce
a biphasic shock waveform, according to the calculated parameters,
then deliver the shock to the cardiac pads placed on the SCA
patient. Shock Ctrl 1355 asynchronously sends a communication to
Ops Ctrl 1305 (indicated by a dashed arrow 1359) to indicate, for
example, that a shock has been delivered to the cardiac pads, as
well as additional information such as the waveform parameters and
patient vital signs.
[0133] FIG. 14 shows a standby process flow 1400 showing the
firmware process for AED standby mode, in accordance with an
embodiment. Standby process flow 1400 begins when the AED module is
brought into service in a step 1405. This step may involve, for
example, the insertion of a 9V battery into the appropriate
receptacle, or the removal of an insulating strip from the battery
compartment to bring the power source in contact with the rest of
the internal circuitry. Then a decision 1407 is made to determine
whether the AED is to be activated in the normal mode of operation.
If the decision is YES, then Stdby 1310 sends standby signal 1312
to Ops Ctrl 1305 to commence normal, non-standby functions of AED
module in service, as was also shown in FIG. 13. If decision 1407
is NO, then Stdby 1310 activates the AED module in an On-the-shelf
(low power) mode in a step 1410.
[0134] While in low power mode, in the embodiment shown in FIG. 14,
Stdby 1310 is activated on a preset schedule to check the status of
the batteries in a periodic wake-up step 1415. In one aspect, a
message 1417 is then sent to a step 1420 in Charge BTM 1315 to
check the status of the household battery that is used to charge
the capacitor (or multiple capacitors). A decision 1425 is made at
Charge BTM 1315 to determine whether the charging battery status is
okay (i.e., there is enough charge left in the charging battery to
power the necessary therapeutic shock). Whether the charging
battery status is YES okay or NO not okay, the battery status is
recorded in a step 1430. Sequentially, or in parallel, a message
1442 is sent to a step 1443 in Control BTM 1320 to check the status
of a separate battery that is used to power the control circuitry
in the AED module, in accordance with an embodiment. A
determination is made in a decision 1445 whether or not the
controller battery status is okay and, whether the status is YES
okay or NO not okay, the battery status is again recorded in step
1430. The status of both the charging battery and the controller
battery are sent to UI 1325 in a step 1450, then displayed to the
user in a step 1460.
[0135] Considering now FIGS. 15 and 16, an exemplary embodiment of
a process that is started when a signal 1312 to commence the shock
protocol of the AED is illustrated. When signal 1312 is received at
Ops Ctrl 1305, a step 1505 initializes the AED module for normal
operation. In a step 1510, a command to place the cardiac pads on
the SCA patient is sent to UI 1325, at which an indicator or
display message instructs the user to place the cardiac pads, in a
step 1515. Then, in a step 1520, a multi-shock protocol is
initialized at Multi-Shock 1335, where "multi-shock" refers to the
treatment protocol in which, if certain preset conditions are met,
then a series of shocks can be generated at the AED module then
applied to the SCA patient as needed. The initialization of the
multi-shock protocol at Multi-Shock 1335 indicates to Multi-Shock
1335 the start of an emergency session involving an SCA patient,
and that future requests for authorization to shock are related to
this specific SCA patient. Then, in a step 1525, logic to control
the number of allowed shocks is initialized at Multi-Shock 1335.
The logic may include, for example, an analysis of the number of
shocks already applied, and the current status of the physiological
indicators measured from the SCA patient. In a step 1530, a request
is made to Multi-Shock 1335 to request authorization to apply a
shock. The logic within Multi-Shock 1335 analyzes the request and,
in a decision 1540, determines whether to approve the generation
and application of a shock to the SCA patient. If the answer to
decision 1540 is NO, then the process is ended in a step 1542. If
the answer to decision 1540 is YES, then the process moves back to
Ops Ctrl 1305, as shown in FIG. 16.
[0136] Referring now to FIG. 16, a YES result of decision 1540 from
Multi-Shock 1335 is communicated to Ops Ctrl 1305, at which a step
1605 issues a command to Charge Mod 1345 to charge the capacitor.
At the same time, or sequentially, Ops Ctrl 1305 begins monitoring
the patient in a step 1607. The monitoring involves, for example,
sensing the cardiac pad placement on the SCA patient in a step 1615
at Pads Mon 1330. The feedback from the cardiac pads, such as the
correct placement of the cardiac pads on the SCA patient, are
monitored in a step 1617 at Pads Mon 1330, and the results are fed
back to a step 1610 to process the various monitoring signals.
Patient monitoring of step 1607 may also include monitoring the
vital signs of the SCA patient in a step 1620 at Subject Mon 1350.
The vital signs, such as cardiac rhythm, are fed back to step 1610
to be monitored. Additionally, Subject Mon 1350 also determines, in
a decision 1625, whether or not the detected cardiac rhythm
corresponds to a shockable rhythm, as previously described above.
If the answer to decision 1625 is YES, then the result is
communicated to step 1610 as part of the signal monitoring. If the
answer to decision 1625 is NO, then Subject Mon 1350 returns to
step 1620 to continue monitoring the vital signs.
[0137] In an embodiment, at Charge Mod 1345, a step 1635 enables
the capacitor charging circuitry, and the capacitor charging status
is monitored in a step 1640. A decision 1642 determines whether the
capacitor has been sufficiently charged to enable the application
of a shock to the SCA patient. If the answer to decision 1640 is
YES, then the result is communicated to step 1610. If the answer to
decision 1640 is NO, then Charge Mod 1345 returns to step 1640 to
continue monitoring the capacitor charge status.
[0138] The monitored signals from step 1610 are then fed into a
decision 1645 to determine whether both the charging system and the
SCA patient are ready for the application of a shock. If the answer
to decision 1645 is NO, then Ops Ctrl 1305 continues to monitor the
incoming signals in step 1610. If the answer to decision 1645 is
YES, then Ops Ctrl 1305 commands the user to stand clear of the SCA
patient in a step 1650, which is communicated through UI 1325,
which instructs the user to stand clear via a display message or
other means in a step 1652. After a set time period, such as 5 to
10 seconds during which the user should have stood back from the
SCA patient, Ops Ctrl 1305 warns the user in a step 1655 of the
incoming shock, which is communicated to the user in a step 1657 at
UI 1325. Ops Ctrl 1305 then requests a shock in a step 1660, which
prompts Shock Ctrl 1355 to initiate a shock management protocol in
a step 1662. Upon completion of the shock application, Ops Ctrl
1305 goes into a follow-up protocol step 1665.
[0139] Turning now to FIG. 17, further details of the processing
performed by Subject Mon 1350, in accordance with an embodiment,
are described. Subject Mon 1350, as shown in FIGS. 16 and 17,
receives a signal from Ops Ctrl 1305 to begin patient monitoring.
When this signal is received at Subject Mon 1350, a step 1705
initializes the patient monitoring circuitry provided with the AED
module. For example, sensors for electrocardiograph monitoring,
cardiac rhythm monitoring, and respiratory rhythm can be included
with the AED module. The various monitored signals are recorded in
a step 1710 at Event Recording Module 1330, and also returned to
Ops Ctrl 1305 to step 1610 of processing the various monitoring
signals. The patient vital signs so measured are also fed into a
step 1715 to apply a shockability analysis algorithm, as previously
described, then to decision 1625 to determine whether the SCA
patient is exhibiting a shockable cardiac rhythm.
[0140] FIGS. 18 and 19 illustrate further details of step 1662
initiate shock management protocol as shown in FIG. 16, in
accordance with an embodiment. The shock management protocol
involves the firmware process for managing a shock protocol and
generating an electric shock, in accordance with an embodiment.
When Ops Ctrl 1305 requests a shock to be generated in step 1660,
Shock Ctrl 1355 receives the request and initializes a body
impedance measurement circuit in a step 1805. Then, using sensors
in the cardiac pads, for example, or by other measurement mechanism
provided with the particular embodiment of the AED module, the body
impedance of the SCA patient is measured in a step 1810. The
measured body impedance is recorded at Event Recording Module 1340
in a step 1815.
[0141] Continuing to refer to FIG. 18, a decision 1820 is made to
determine whether the body impedance measured in step 1810 is
within the range in which the AED module power circuitry can adjust
the shock waveform for safe application to the particular patient.
For instance, if a biphasic waveform, such as shown in FIG. 12 is
to be used for the shock, there is a range of body impedance values
for which the AED module is able to accommodate and adjust the
waveform parameters for application of shock within American Heart
Association guidelines. If the measured body impedance is lower
(i.e., the SCA patient is too small) or higher (i.e., the SCA
patient is too large) than the range of allowable body impedance
values, then Ops Ctrl 1305 is so notified in a step 1825 and no
shock is administered. Shock Ctrl 1355 then instructs UI 1325 to
display an error message in a step 1830, and UI 1325 accordingly
displays an error message for the user in a step 1832.
[0142] If decision 1820 determines that the measured body impedance
is within the range for which a suitable waveform can be generated,
then the necessary waveform parameters are calculated in a step
1840. Step 1840 involves, for example, uses an algorithm that,
given vital sign measurements from the patient such as, but not
limited to, body impedance, cardiac rhythm, and ECG data,
calculates the appropriate timing and amplitudes of the positive
and negative phases of the generated waveform, as shown in
previously discussed FIG. 11. The calculated waveform parameters
are recorded at Event Recording module 1340 in a step 1845, then
instructions are sent to the high voltage drivers in the AED module
to power up in a step 1850.
[0143] Referring now to FIG. 19, once the high voltage drivers are
powered up in step 1850, Shock Ctrl 1355 instructs the high voltage
drivers to generate a timed positive phase component of a biphasic
waveform shock in a step 1905. Shock Ctrl 1355 monitors the
generation of the timed positive phase component and, in a decision
1910, determines whether the generation of the timed positive phase
component is complete. If decision 1910 determines that the high
voltage drives have not completed the generation of the timed
positive phase component, then Shock Ctrl 1355 continues to monitor
the high voltage drivers. When the result of decision 1910 is YES,
then Shock Ctrl 1355 instructs the high voltage drivers to generate
the timed interphase, or quiescent, component between the positive
and negative phases of the biphasic waveform in a step 1915. Again,
Shock Ctrl 1355 monitors the generation of the timed interphase
component and, in a decision 1920, determines whether the
generation of the timed interphase component is complete. If
decision 1920 determines that the timed interphase component
generation is not yet complete, then Shock Ctrl 1355 continues to
monitor the high voltage drivers. When the result of decision 1920
is YES, then Shock Ctrl 1355 instructs the high voltage drivers to
generate the timed negative phase component in a step 1925. Yet
again, Shock Ctrl 1355 monitors the generation of the timed
negative phase component and, in a decision 1930, determines
whether the generation of the timed negative phase component is
complete. If decision 1930 determines that the timed negative phase
component generation is not yet complete, then Shock Ctrl 1355
continues to monitor the high voltage drivers. When the result of
decision 1930 is YES, then Shock Ctrl 1355 instructs the high
voltage drivers to power down in a step 1935 and proceeds to the
follow-up protocol at Ops Ctrl 1305. The details of the shock event
are also recorded at Event Recording Module 1340 in a step
1940.
[0144] In another embodiment, the portable AED is configured to be
housed in a bracket, which is mountable on a wall or other
location. The bracket can include, for example, a connection to a
power outlet such that the bracket can serve as a charging station
for the AED, if a rechargeable battery is used within the AED
module, or to provide additional functions. For instance, the
bracket provides a monitoring function for the AED so as to alert
the user, e.g., via a visual warning on the bracket or
communication through the associated mobile device application or
user webpage, in the case of situations such as: 1) the AED has
been removed from the bracket; 2) a battery in the AED is low and
needs to be replaced; and 3) the AED has a problem and needs to be
serviced. The bracket can also include a button, either a physical
button or on a touch screen, to immediately alert EMS or other
contacts programmed into the mobile device application in the case
of an emergency.
[0145] An exemplary embodiment of a bracket is shown in FIG. 20. A
bracket system 2000 includes a bracket body 2010, which in turn
includes one or more lips 2012 (three are shown in the embodiment
illustrated in FIG. 20) for housing an AED module (not shown) when
the AED module is not in use. In the example shown in FIG. 20,
bracket system 2000 includes an emergency call button 2020, which
can be pressed by a user to immediately contact emergency medical
services (e.g., via a 911 call in the US). Alternatively, call
button 2020 can be replaced by a touchscreen including an emergency
call function as well as being capable of displaying additional
information, such as the AED battery status and AED user guidance.
Call button 2020 (or a touchscreen equivalent) can also be
configured to alert specified contacts programmed into a software
application installed on a mobile device. For instance, the
firmware in bracket system 2000 can be configured to automatically
contact EMS as well as specified contacts (e.g., relatives and
friends) programmed into the software application on a mobile
device paired with bracket system 2000.
[0146] Bracket system 2000 also includes a sensor 2022 for
detecting whether the AED module is housed in bracket body 2010.
For instance, when the AED module is housed in bracket body 2010,
sensor 2022 detects the presence of the AED module such that
bracket system 2000 remains in a low power mode. When the AED
module is removed from bracket system 2000, then bracket system
2000 goes into an active mode, in which certain functions of the
bracket system 2000 are activated. Optionally, bracket system 2000
can be configured such that, when sensor 2022 detects that the AED
module has been removed from bracket system 2000, bracket system
2000 automatically prompts the user to contact EMS or even
immediately contact EMS without additional user input.
[0147] As shown in FIG. 20, bracket system 2000 also includes an
indicator 2024, which can be used to show the user the status of a
Wi-Fi connection or cellular signal strength, if bracket system
2000 is configured to be connectable to an external communication
system. Bracket system 2000 also includes a microphone 2030 and a
speaker 2035 to facilitate hands-free communications with EMS via
bracket system 2000. For instance, when the AED module is removed
from bracket system 2000, bracket system 2000 automatically alerts
EMS that there is an emergency situation, and also prompts the user
by audio (as shown in FIG. 20) or by visual prompt (e.g., if a
touchscreen is used instead of emergency call button 2020). As an
example, the removal of the AED module from bracket system 2000
leads to bracket system 2020 automatically contacting EMS and
generating a voice prompt 2037 to the user. As an option, a lag
time of, for instance, one minute may be given between the time the
AED module is removed from bracket system 2000 to when EMS is
contacted such that, if the AED module is accidentally removed, the
user is given time to replace the AED module and avoid
unnecessarily contacting EMS.
[0148] FIGS. 21-23 illustrate an exemplary embodiment of a portable
AED module having features as described above. A portable AED
module 2100 has dimensions of approximately 8-inches by 6-inches by
3-inches, and is shown in ISO, side, and bottom views in FIGS.
21-23, respectively. As shown in the exemplary embodiment, portable
AED module 2100 is powered by a battery arrangement 2110 including
a plurality of batteries 2112. In the embodiment shown in FIGS.
21-23, batteries 2112 are four CR123 batteries, which are
commonly-available household batteries. AED module 2100 also
include various connection ports 2120 and 2210 that provide
connections for the cardiac pads, as well as test inputs and
outputs. Outer enclosure 2150 of portable AED module 2100 is
configured to minimize the risk of shock to the user, as well as to
protect the internal electronic circuitry of the AED module from
hazards, such as electrostatic discharge (ESD) and moisture.
Portable AED module 2100 further includes a plurality of button
switches 2170 for accessing various functionalities of portable AED
module 2100, as well as serving as status indicators by color coded
illumination of the button switches. Using a single household 9V
alkaline battery, a high voltage of 1700V was achieved in 48
seconds, without current limiting, on the first charge cycle, and
in 55 seconds, with current limiting for safety and battery power
conservation. Embodiments replacing the 9V battery with four CR123
batteries in series have been demonstrated to achieve even faster
charge times around 30 seconds using custom circuitry.
[0149] Turning now to FIG. 24, an example of an electronics
architecture 2400 suitable for use with a portable AED module, in
accordance with an embodiment, is shown. Electronics architecture
2400 includes a microcontroller 2410 (equivalent to microprocessor
20 of FIG. 2) overseeing the operations of a logic control circuit
2420. Power to microcontroller 2410 and logic control circuit 2420
are supplied via a logic supply circuit 2430 from a dedicated
controller battery 2435, which is separate from a battery used to
generate the therapeutic charge in the portable AED module, such
that the controller operations do not drain the charge battery. The
power source for the actual charge generation is a charge battery
2450, which is shown as a 9V battery in FIG. 24, although other
types of household batteries can be used as well. A current limiter
2455 adjusts the current drawn from charge battery 2450 for the
charge generation. Current from charge battery 2450 is directed
through a high voltage DC-DC converter 2460, from which the output
is used to charge a high voltage capacitor 2465. Logic control
circuit 2420 provides the necessary logic for safely operating high
voltage DC-DC converter 2460, as well as discharging high voltage
capacitor 2465, if the generated charge is not needed or the
operation of the portable AED module is interrupted. The charge
stored in high voltage capacitor 2465 is output to the cardiac pads
(shown in FIG. 24 as "paddles") via an H Bridge 2470 controlled by
an H Bridge driver 2475, which in turn is controlled by logic
control circuit 2420. H Bridge driver 2475 controls the generation
of the appropriate shock waveform, such as a biphasic waveform,
with the appropriate waveform parameters suitable for the specific
SCA patient, as indicated by vital signs measurements. Electronics
architecture 2400 is suitable for use, for example, with the
firmware configuration described in relation to FIGS. 13-19.
[0150] The illustrations of arrangements described herein are
intended to provide a general understanding of the structure of
various embodiments, and they are not intended to serve as a
complete description of all the elements and features of apparatus
and systems that might make use of the structures described herein.
Many other arrangements will be apparent to those of skill in the
art upon reviewing the above description. Other arrangements may be
utilized and derived therefrom, such that structural and logical
substitutions and changes may be made without departing from the
scope of this disclosure. Figures are also merely representational
and may not be drawn to scale. Certain proportions thereof may be
exaggerated, while others may be minimized. Accordingly, the
specification and drawings are to be regarded in an illustrative
rather than a restrictive sense.
[0151] In the foregoing specification, specific embodiments have
been described. However, one of ordinary skill in the art
appreciates that various modifications and changes can be made
without departing from the scope of the invention as set forth in
the claims below. Accordingly, the specification and figures are to
be regarded in an illustrative rather than a restrictive sense, and
all such modifications are intended to be included within the scope
of present teachings. The descriptive labels associated with the
numerical references in the figures are intended to merely
illustrate embodiments of the invention, and are in no way intended
to limit the invention to the scope of the descriptive labels. The
present systems, methods, means, and enablement are not limited to
the particular systems, and methodologies described, as there can
be multiple possible embodiments, which are not expressly
illustrated in the present disclosures. It is also to be understood
that the terminology used in the description is for the purpose of
describing the particular versions or embodiments only, and is not
intended to limit the scope of the present application.
[0152] Some embodiments, illustrating its features, will now be
discussed in detail. The words "comprising," "having,"
"containing," and "including," and other forms thereof, are
intended to be equivalent in meaning and be open ended in that an
item or items following any one of these words is not meant to be
an exhaustive listing of such item or items, or meant to be limited
to only the listed item or items. It must also be noted that as
used herein and in the appended claims, the singular forms "a,"
"an," and "the" include plural references unless the context
clearly dictates otherwise. Although any methods, and systems
similar or equivalent to those described herein can be used in the
practice or testing of embodiments, the preferred methods, and
systems are now described. The disclosed embodiments are merely
exemplary.
* * * * *
References