U.S. patent application number 14/743882 was filed with the patent office on 2015-10-08 for wearable defibrillator with a multivector shock waveform.
The applicant listed for this patent is West Affum Holdings Corp.. Invention is credited to Isabelle Banville, Richard C. Nova, Joseph L. Sullivan.
Application Number | 20150283390 14/743882 |
Document ID | / |
Family ID | 51388918 |
Filed Date | 2015-10-08 |
United States Patent
Application |
20150283390 |
Kind Code |
A1 |
Sullivan; Joseph L. ; et
al. |
October 8, 2015 |
Wearable Defibrillator With A Multivector Shock Waveform
Abstract
A transthoracic defibrillator for external defibrillation
comprises at least three electrodes configured to be attached to
the thorax of a patient to establish at least two electrical paths
across the thoracic cavity and through the heart of the patient. In
addition, a defibrillator circuit contained in a defibrillator
housing has the capability to deliver a different defibrillation
waveform across each of the at least two electrical paths.
Inventors: |
Sullivan; Joseph L.;
(Redmond, WA) ; Banville; Isabelle; (Redmond,
WA) ; Nova; Richard C.; (Redmond, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
West Affum Holdings Corp. |
Grand Cayman |
|
KY |
|
|
Family ID: |
51388918 |
Appl. No.: |
14/743882 |
Filed: |
June 18, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14189789 |
Feb 25, 2014 |
9089685 |
|
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14743882 |
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61769098 |
Feb 25, 2013 |
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Current U.S.
Class: |
607/6 ; 607/142;
607/7 |
Current CPC
Class: |
A61B 5/686 20130101;
A61N 1/3993 20130101; A61B 5/0538 20130101; A61N 1/046 20130101;
A61N 1/3904 20170801; A61N 1/0484 20130101; A61N 1/3918 20130101;
A61N 1/39044 20170801; A61N 1/3937 20130101 |
International
Class: |
A61N 1/39 20060101
A61N001/39; A61N 1/04 20060101 A61N001/04 |
Claims
1. A transthoracic defibrillator for external defibrillation,
comprising: at least three electrodes configured to be attached to
a patient to establish at least two electrical paths across the
thoracic cavity and through the heart of the patient; and a
defibrillator circuit (700) comprising a discharge circuit (755)
including a half-bridge circuit for each of said at least three
electrodes, and an energy storage capacitor (752) coupled to the
discharge unit, wherein each half-bridge circuit is operatively
connected to a corresponding one of the at least three electrodes,
and wherein the defibrillator circuit is configured to deliver a
defibrillation waveform across each of the at least two electrical
paths; wherein the discharge circuit is controllable to cause
stored energy to be discharged to the electrodes to create
multiphasic pulses forming the defibrillation waveform across each
of the at least two electrical paths; wherein each of the at least
three electrodes is incorporated into a garment or belt that can be
worn by the patient.
2. The defibrillator of claim 1, wherein: the defibrillator circuit
further comprises a measurement circuit (720) configured to
determine the number of currently established electrical paths
between the at least three electrodes; wherein the defibrillator
circuit is configured to deliver the defibrillation waveform across
only one currently established electrical path if only one
electrical path is currently established.
3. The defibrillator of claim 1, wherein: the defibrillator circuit
is configured to accept input from a user to indicate which pairs
of electrodes form designated electrical paths and which
defibrillation waveforms are used on which designated electrical
paths; and the defibrillator circuit is configured to deliver the
indicated defibrillation waveforms across the designated electrical
paths.
4. The defibrillator of claim 1, wherein: the defibrillator circuit
further comprises a measurement circuit (720) configured to measure
an impedance between at least two pairs of electrodes.
5. The defibrillator of claim 4, wherein the defibrillator circuit
is configured to measure impedance simultaneously across at least
two pairs of the electrodes using carrier frequencies that differ
by at least 5 kHz between each of the simultaneously tested
pairs.
6. The defibrillator of claim 4, wherein the defibrillator circuit
is configured to measure impedance sequentially between different
pairs of the electrodes.
7. The defibrillator of claim 4, wherein: the defibrillator circuit
is configured to measure impedance at least once at a time that is
after the defibrillator is put on the patient and before the
patient is in cardiac arrest.
8. The defibrillator of claim 4, wherein the vectors are chosen by
the defibrillator circuit to be the two pairs of electrodes with
highest measured impedance.
9. The defibrillator of claim 4, wherein a parameter of the
defibrillation waveform along each vector is influenced by a
measured impedance between the electrodes of a vector.
10. The defibrillator of claim 9, wherein the parameter is the
energy delivered.
11. The defibrillator of claim 9, wherein the parameter is the
waveform duration.
12. The defibrillator of claim 11, wherein the defibrillator
circuit is configured to: measure the impedance along one vector;
determine the pulse width of the defibrillation waveform across
each vector based at least in part on the impedance measurement;
and cause the duration of the of the waveform along each vector to
be substantially the same.
13. The defibrillator of claim 11, wherein the defibrillator
circuit is configured to control the waveform duration along each
vector to cause the energy delivered along each vector to be
substantially the same.
14. The defibrillator of claim 9, wherein the parameter is the
waveform tilt.
15. The defibrillator of claim 14, wherein the defibrillator
circuit is configured to control the waveform duration along each
vector to cause the waveform tilt along each vector to be
substantially the same.
16. The defibrillator of claim 9, wherein a parameter of the
defibrillation waveform along at least one vector is influenced by
the measured impedance between the electrodes of that vector.
17. The defibrillator of claim 9, wherein a parameter of the
defibrillation waveform along at least one vector is influenced by
the measured impedance between the electrodes of a different
vector.
18. The defibrillator of claim 4, wherein there is only one
designated vector; and the designated vector corresponds to the
lowest measured impedance amongst all pairs of electrodes.
19. The defibrillator of claim 1, wherein two electrical paths form
a first vector and a second vector; and the defibrillation
waveforms comprise a sequence of non-zero voltages including a
positive shock on the first vector, followed by a positive shock on
the second vector, followed by a negative shock on the first
vector, followed by a negative shock on the second vector.
20. The defibrillator of claim 19, wherein the defibrillator
contains a single capacitor in an energy storage module; and the
duration of the shock on each vector is determined by the impedance
between the electrodes of that vector.
21. The defibrillator of claim 1, wherein two electrical paths form
a first vector and a second vector; and the defibrillation
waveforms comprise a sequence of non-zero voltages including a
positive shock on the first vector, followed by a positive shock on
the second vector, followed by a negative shock simultaneously on
the first and second vectors.
22. The defibrillator of claim 1, wherein the defibrillator circuit
is configured to measure the patient's electrocardiogram via the
electrodes also used to deliver the defibrillation waveforms.
23. The defibrillator of claim 22, wherein two of the at least
three electrodes are used to measure the electrocardiogram signal
and a third of the at least three electrodes is used as a reference
electrode.
24. The defibrillator of claim 1, wherein: the at least three
electrodes include exactly four electrodes providing six possible
electrical paths; and a first set of vectors are two electrical
paths chosen from the six possible electrical paths; a second set
of vectors are two lectrical paths chosen from the six possible
electrical paths, wherein the second set of vectors is different
from the first set of vectors; and if the first set of
defibrillation waveforms delivered across the first set of vectors
fail to establish a regular heart rhythm in the patient, the
defibrillator circuit is configured to deliver a second set of
defibrillation waveforms across the second set of vectors.
25-26. (canceled)
27. A transthoracic defibrillator for external defibrillation,
comprising: four electrodes configured to be attached to a patient
and establish electrical paths across a thoracic cavity and through
the heart of the patient; wherein a first pair of the four
electrodes, when attached to the patient, forms a first electrical
path for a first shock vector; and wherein a second pair of the
four electrodes, when attached to the patient, forms a second
electrical path for a second shock vector; and a defibrillator
circuit, wherein: the defibrillator circuit is operatively
connected to the four electrodes; the defibrillator circuit
contains an energy storage module with a single capacitor to supply
both shock vectors; the defibrillator circuit is configured to
measure an impedance across the electrodes of both shock vectors;
the defibrillator circuit is configured to deliver a first
defibrillation waveform through the first shock vector, where the
duration of the first defibrillation waveform is proportional to
the impedance measured across the first pair of electrodes; and the
defibrillator circuit is configured to deliver a second
defibrillation waveform through the second shock vector, where the
duration of the second defibrillation waveform is proportional to
the impedance measured across the second pair of electrodes.
28. The defibrillator of claim 27, wherein the defibrillator
circuit includes a single capacitor in the energy storage module.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/189,789 filed Feb. 25, 2014, which claims
the benefit of U.S. Provisional Application No. 61/769,098, filed
Feb. 25, 2013, which are hereby incorporated by reference in their
entirety.
TECHNICAL FIELD
[0002] The present invention relates generally to external
defibrillators, and more particularly to a multivector shock
protocol for use by an external, wearable defibrillator.
BACKGROUND
[0003] The energy delivered by a defibrillator is typically
expressed in Joules. Energy has become a surrogate for current in
modern defibrillator language, but electrical current is what
actually defibrillates the heart. A Joule is the unit of work
associated with one amp of current passed through one ohm of
resistance for one second. Electrical current may be expressed as
the ratio of voltage/impedance. Both the patient and the electrical
circuit of the defibrillator contain impedance, which is expressed
in ohms
[0004] A multivector shock is one which utilizes three or more
therapy electrodes to deliver electrical current along at least two
separate current paths. Studies have shown that multivector shocks
can substantially reduce the energy required for defibrillation.
For example, Pagan-Carlo et al. (JACC 1998) demonstrated that a
multivector shock can defibrillate pigs with about 40% less energy
than a standard biphasic truncated exponential (BTE) waveform. FIG.
1 is an illustration of the electrode positions used in this study
and the timing of the associated waveforms. The authors used three
electrodes to generate a series of 7 different shock vectors.
According to this method, current is initially delivered from
electrode 1 to electrode 2. This continues for 1 ms, then current
is delivered from electrode 1 to electrodes 2 and 3 together. This
continues for another millisecond. Then current is delivered from
electrodes 1 and 2 to electrode 3. The shock sequence continues to
switch between electrode combinations (i.e. "vectors") until all
seven vectors have been energized.
[0005] A circuit for delivering a three electrode multivector shock
is shown in FIG. 2. Note that this implementation delivers a
multivector shock from a single capacitor. In this respect, it is
different from the configuration disclosed by published patent
application US 2005/0107834, entitled "Multi-path Transthoracic
Defibrillation and Cardioversion". As shown, the circuit of FIG. 2
contains three half-bridges, one for each electrode. If more
electrodes were utilized, more half-bridges would be required. Each
of the switches could be a semiconductor switch such as an IGBT
(insulated-gate bipolar transistor), SCR (silicon-controlled
rectifier), MOSFET (metal-oxide-semiconductor field-effect
transistor), BiMOSFET (bipolar MOSFET), or similar device. The
switches in the FIG. 2 circuit are operated sequentially to deliver
current to different combinations of electrodes as described
above.
[0006] While Pagan-Carlo achieved good results with their shock
sequence of 7 vectors, it is not clear whether that particular
sequence is optimal or necessary. A smaller number of shock vectors
may be equally efficacious as well as being easier to implement.
For example, two shock vectors (electrode 1->electrode 2,
followed by electrode 1->electrode 3) may be appropriate. In
other words, a shock sequence with two or more vectors may be
superior to a standard single-vector shock.
[0007] Historically, in defibrillator applications, multivector
waveforms have been unattractive because of the difficulty of
properly applying three or more electrodes to a patient. When a
rescuer is treating a cardiac arrest patient, time is of the
essence. The extra time required to apply extra defibrillation pads
could be critical for survival. Applying a back pad is particularly
difficult to do to a patient that is unconscious. Also, training
rescuers to apply pads in novel, new locations would be difficult
and confusing.
[0008] Many of the obstacles that complicate the application of a
multivector shock can be overcome by a carefully designed wearable
defibrillator. A wearable defibrillator may include a garment (such
as a vest), a belt, or other arrangement that provides access to
multiple points on the patient's thorax. This garment may allow
multiple therapy electrodes to be easily placed in advantageous
locations without extra hassle or confusion. Because the patient is
conscious it is not difficult to access the patient's back.
[0009] A multivector defibrillator may be particularly advantageous
for a wearable defibrillator because it may allow the use of
smaller therapy electrodes. Pagan-Carlo proposed an "overlapping
encircling" shock scheme that uses the available electrodes in
different combinations to create a rotating shock vector that
sweeps around the heart. This scheme uses electrodes in pairs and
threesomes to create seven different shock vectors.
[0010] For a conventional two-electrode (single vector)
defibrillation shock the size of the pads plays a role in ensuring
the proper current distribution through the heart. In order for the
shock to be successful, enough of the heart must receive enough
current to depolarize the heart cells. Pads that are too small may
not deliver enough current to some parts of the heart. In contrast
to a conventional defibrillator, a multivector defibrillator may be
able to use smaller pads because current flow through all parts of
the heart is guaranteed by the multivector waveform not by pad size
alone.
[0011] Therapy electrodes for multivector defibrillation might be
applied to the patient in different arrangements. Pagan-Carlo
suggested that the three pads be equally distributed around the
perimeter of the thorax. This could be implemented using two
anterior pads, one approximately beneath each breast, and one
posterior pad in the middle of the back. Alternatively, there could
be one anterior pad over the sternum and two back pads. Although
Pagan-Carlo's arrangement worked well for pigs it is unclear
whether it would be ideal for humans. The cross-section of a pig's
thorax is much more cylindrical than a human's thorax and
electrodes placed laterally on a human could deliver current
relatively far from the heart.
SUMMARY
[0012] A goal of the present invention is to leverage such an
energy reduction to design a small and lightweight defibrillator,
e.g., a wearable defibrillator (although the invention is by no
means limited to a wearable device). As described below, two
aspects of the present invention concern placement of the
electrodes to avoid current through the patient's lungs, and
controlling the total tilt of the multivector waveform.
[0013] In wearable defibrillators, the energy storage capacitor can
be the single largest component of the defibrillator. The energy
storage capacitor and energy delivery circuit do not lend
themselves to miniaturization like other electronic components do.
These components can be reduced in size, however, by reducing the
energy of the electrical waveforms delivered to the patient. The
present disclosure provides one way of reducing the energy. For
example, the present invention could enable construction of a 90
Joule wearable defibrillator that has the same shock success rate
as a 150 Joule wearable defibrillator. This would allow the
inventive wearable defibrillator to be smaller and lighter weight,
providing a significant customer advantage.
[0014] In a first embodiment of the present invention, a
transthoracic defibrillator for external defibrillation comprises
at least three electrodes configured to be attached to the thorax
of a patient to establish at least two electrical paths across the
thoracic cavity and through the heart of the patient. In addition,
a defibrillator circuit contained in a defibrillator housing is
operatively connected to the at least three electrodes and has the
capability to deliver a different defibrillation waveform across
each of the at least two electrical paths.
[0015] Another aspect of the present invention provides a method of
transthoracic defibrillation. An illustrative embodiment of the
inventive method comprises the step of attaching at least two
electrodes to the thorax of a patient to establish at least a first
electrical path across the thoracic cavity and through the heart of
the patient. In addition, in this embodiment, the method includes
determining if the patient is in ventricular tachycardia (VT),
ventricular fibrillation (VF), or atrial fibrillation (AF), and
establishing at least a second electrical path if VF or AF is
determined The step of establishing at least a second electrical
patent comprises attaching at least one additional electrode to the
thorax of the patient to establish at least one additional
electrical path across the thoracic cavity and through the heart of
the patient. Finally, a defined amount of electrical energy is
delivered as a first shock across at least one of the electrical
paths.
[0016] Other features of the present invention are described
below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 depicts the electrode positions used in the
Pagan-Carlo study and the timing of the associated waveforms.
[0018] FIG. 2 depicts circuit for delivering a three-electrode
multivector shock.
[0019] FIG. 3A depicts a number of interesting shock waveforms
tested for use with illustrative embodiments of the present
invention, and FIG. 3B depicts how a prior-art defibrillator
adjusts the shock waveform for impedances of 50, 100, and 150
ohms.
[0020] FIG. 4 depicts multivector waveforms for impedances of 50,
100, and 150 ohms These are similar to the waveforms of FIG. 3B but
with each phase divided between two or more vectors.
[0021] FIGS. 5A and 5B depict examples of an external, wearable
defibrillation system.
[0022] FIG. 6 depicts a table summarizing three main types of
external defibrillators.
[0023] FIG. 7 is a diagram showing possible components of an
external defibrillator made according to embodiments of the present
invention.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0024] As mentioned, an illustrative embodiment of the present
invention is suitable for use as a wearable defibrillator for human
patients. One example of a multivector arrangement for humans would
be a four electrode configuration with two pads in standard
apex-sternum positions along with two electrodes in standard
anterior-posterior position. (Readers skilled in the art of
defibrillators are assumed to know the standard positions for
electrodes.) This would allow for two orthogonal current paths both
of which would be along vectors that are known to be effective.
[0025] In the following detailed description, we describe
illustrative examples of electrode placement and waveform control
protocols in accordance with the present invention. We also
describe example embodiments of external defibrillator hardware
structures in accordance with the present invention.
[0026] Electrode Placement to Avoid Current Through the Lungs
[0027] Multiple electrodes could be placed on a single pad
substrate for easier application and positioning and cable
management. One of the problems with a standard apex-sternum pad
placement is that current flow must go through the lungs. Lungs are
relatively high impedance so they tend to restrict current flow.
Electrodes placed centrally on the chest and back can create
current paths that avoid the lungs and may deliver a higher
fraction of the current to the heart. A multivector electrode
arrangement that attempts to avoid current paths through the lungs
could have two anterior pads, both placed along the center line of
the chest, and one or more back pads. Alternatively, it could have
two back pads with both placed near the spine and a single chest
electrode. In either of these arrangements a multivector shock
sequence could be generated by delivering current sequentially
along different current paths that are generated by connecting the
energy to electrodes in different combinations.
[0028] We have tested some multivector waveforms in an animal lab
setting. This study compared single vector biphasic shocks with
multivector biphasic shocks. The multivector shocks were delivered
with four electrodes, with electrodes A and B placed in an
anterior-posterior position, and electrodes C and D placed in
lateral-lateral position. A number of shock waveforms were tested,
but the most interesting are illustrated in FIG. 3A.
[0029] In FIG. 3A, Test shock 1 has four sub-pulses: a 3 ms
positive pulse along vector A-B, a 3 ms positive pulse along D-C, a
negative 3 ms A-B pulse, and a negative 3 ms C-D pulse. For Test
shock 3 the first two sub-pulses are the same as Test shock 1, but
the negative pulse is 6 ms and is given along vectors A-B and C-D
simultaneously. Both of these waveforms defibrillated with about
40% less energy than a conventional single-vector BTE shock. Such a
shock waveform could allow a 90 J multivector defibrillator to have
the same shock success rate as a 150 J single-vector
defibrillator.
[0030] These shock waveforms are intended for a defibrillator that
uses a single capacitor and uses a waveform that is
time-multiplexed between vectors. A multivector waveform may adjust
the pulse width to accommodate patients with different impedances.
FIG. 3B is an illustration of how a prior-art defibrillator adjusts
the shock waveform for different impedances (50, 100, and 150 ohms)
A multivector defibrillator may use a scheme in which each phase is
divided between two or more vectors. The waveforms shown in FIG. 4
all represent single capacitor waveforms. Because all of the energy
is drawn from one capacitor, the starting voltage of one pulse will
equal the trailing edge voltage of the preceding pulse. However,
the current may be different along the two vectors because the
impedance may differ.
[0031] Controlling the Waveform Total Tilt
[0032] One method of controlling the shock waveform is to specify
the total tilt of the waveform (from the leading edge of the first
pulse to the trailing edge of the last pulse) and give four equal
duration sub-pulses. In order to do this, the resistance of each
shock vector should be known. The formula for the duration of the
sub-pulses is:
t=-R1*R2*C*In(tilt)/2(R1+R2)
[0033] where,
[0034] R1=the resistance along one vector
[0035] R2=the resistance along the other vector
[0036] C=the capacitance of the energy storage capacitor
[0037] tilt=the total tilt of the shock waveform
[0038] t=the duration of each sub-pulse.
[0039] Although the present disclosure is suitable for a wearable
defibrillator, a multivector waveform could be useful for
non-wearable defibrillators as well. There are some situations in
which the shock efficacy of existing biphasic defibrillators is
inadequate and patients may benefit from a multivector waveform.
There are also situations in which the drawback of needing to apply
multiple electrodes may not be significant. [0040] Cardioversion of
atrial fibrillation. This is an elective procedure, so there is
plenty of time to apply multiple defibrillation pads. Clinicians
want to cardiovert atrial fibrillation with as little energy as
possible, but there are some patients for whom 360 J is inadequate.
A multivector shock waveform may be able to convert most patients
with less energy. Some of the patients that cannot be converted
with a single vector 360 J shock may be converted with a
multivector 360 J shock. [0041] Electrophysiology lab procedures.
Again, this is an elective procedure. While defibrillation success
rates are generally very in this setting, clinicians have strong
desire to have the most effective therapy possible because they do
not want their patient to die during their procedure. [0042]
Pre-hospital shocks for hard-to-defibrillate patients. Clinicians
sometimes deliver simultaneous shocks with two defibrillators if a
single 360 J shock doesn't work. A 360 J multivector would have a
much higher efficacy than a single-vector shock, possibly
eliminating the need to expose the patient to 720 J of energy.
[0043] Logic for Which Pads to Apply
[0044] There are several options for deciding which electrode pads
to use for a given patient. For example, instructions could be
provided to the user to apply one set of pads for ventricular
tachycardia (VT), which is generally easy to convert, but multiple
pads for ventricular fibrillation (VF) or atrial fibrillation (AF).
This could be included in the instruction manual, or if the device
detects the rhythm type, the device could prompt the user to apply
the appropriate pads.
[0045] Alternatively, one set of pads could be initially applied to
cardiac arrest patients to allow treatment to begin quickly. If
shocks are not effective, then a second set of pads could be
applied.
[0046] Another option is to place two pads in anterior-posterior
position and two pads in anterior-lateral position to form
orthogonal vectors. The two vectors are intended to be orthogonal
and the pads should be placed as far apart as possible.
[0047] Logic for Which Pads to Excite
[0048] Similarly, there are several options for deciding which
electrode pads to excite in a given situation. For example, the
defibrillator could detect which pads were applied to the patient
and apply energy accordingly. If two pads were applied, then energy
would be delivered through those pads alone. If four pads were
applied then a multivector shock would be applied. A single vector
shock could be delivered through pairs of pads thereby increasing
the effective surface area for delivery. Of the four pads the
defibrillator accepts, any two pads could be applied to form a
single shock vector. In other words, it is not necessary for the
pads to come in predefined pairs that must be used together. This
reduces the likelihood of a person making a mistake by applying
only two pads that are not compatible.
[0049] Another option is to permit the user to select which pads
form which vector. If pads A, B, C, and D are applied to the
patient, the operator could tell the device that A-B form the
anterior-posterior vector, and C-D form the lateral-lateral
vector.
[0050] For a wearable defibrillator, the prescribing physician
could decide whether a given patient should receive a single-vector
shock or multivector shock. For a single-vector shock, he or she
could also decide if it is to be an anterior-posterior vector or a
lateral-lateral vector. Patients who are hard to defibrillate may
require a multivector shock. A patient who is easy to defibrillate
may be able to use a single vector shock. If the device is
configured for a single vector, then the patient could wear a
garment that only includes two pads, making the garment more
comfortable.
[0051] Premeasure Impedance with Carrier Frequency
[0052] Before applying a defibrillation shock to a pair of
electrodes it is necessary to verify that the pads are properly
attached to the patient. This is often done with a carrier
frequency. However, if two carrier frequency signals are injected
into a single patient they could interfere with each other. There
are several ways to solve this problem: [0053] a. Measure impedance
between pads A and B with frequency 1, and simultaneously measure
impedance between pads C and D using a different frequency 2.
Frequencies 1 and 2 can differ by significant amounts, for example
60 kHz and 65 kHz. [0054] b. Alternate impedance measurements.
Measure impedance A-B first, then C-D. [0055] c. For a wearable
defibrillator, measure impedance at a different time, possibly
several times each day, but not when the patient is in cardiac
arrest. [0056] d. Continuously monitor wearable device impedance on
each vector. [0057] e. Check impedance between each pair of pads
(six combinations) to detect if the pads have been misapplied. For
example, if pads A and B are supposed to be on opposite sides of
the body and C and D are supposed to be on opposite sides, then the
A-B impedance should be higher than A-C or A-D. Adjust
waveform/vector delivery accordingly to the appropriate path based
upon detected impedance.
[0058] Waveform Control
[0059] The waveform control may be carried out in a number of ways.
Parameters of the waveform that may be controlled include, but are
not limited to, energy delivered, duration of a sub-pulse, duration
of the entire waveform, and the waveform tilt. (The waveform "tilt"
is defined as the ratio of (initial shock current-final shock
current)/(initial shock current). Thus, a rectangular pulse has 0%
tilt, one that decays to zero has 100% tilt, and most defibrillator
waveforms are somewhere in the middle.) Any one of the following
examples may be suited to a given situation: [0060] a. Control each
phase independently to deliver a specific amount of energy, or a
specific tilt. [0061] b. Shocks with interleaved phase 1 and
interleaved phase 2 (Test shock 1 above) or interleaved phase 1 and
common phase 2 (Test shock 3 above). The interleaved phases in FIG.
4 are shown as being the same duration, but they could also be
different. [0062] c. Configure the system to use a single capacitor
to deliver the same amount of energy along each vector, for example
50 J on vector A-B, and 50 J on vector C-D. The capacitor voltage
could be monitored until a predetermined amount of energy was
delivered along one vector, then switch to the other vector. The
duration of the two vectors may be different but the amount of
energy they deliver is the same. [0063] d. Deliver a
time-multiplexed two-vector single capacitor shock through four
electrodes in a manner such that the total duration increases with
increasing impedance to give a specific amount of tilt. The
impedance would be pre-measured along both vectors. The duration of
each vector sub-pulse could be a fixed fraction of the total. The
control of each sub-pulse is not independent--they vary together as
impedance varies. [0064] e. Deliver a single vector shock through
two of the four electrodes based on the lowest impedance
vector.
[0065] ECG Monitoring through Therapy Pads
[0066] With four pads on the patient it is possible to use two pads
to monitor and a third as a reference (right-leg drive). It is also
possible to switch between multiple monitoring vectors, similar to
the manner in which 3 lead ECG monitors switch between vectors. If
enough pads are applied, it may be possible to construct a
multi-lead ECG signal similar to a 12-lead ECG.
[0067] Fault Detection
[0068] If four pads are applied to the patient and a circuit fault
is detected in one portion of the energy delivery circuit, it may
be possible to compensate for the failure by only delivering energy
through the portion of the circuit that is functional. For example,
four half-bridge circuits are required to deliver energy to four
electrodes. If one half bridge was broken, then the device could
deliver a single vector shock through two half bridges, or a
multivector shock through three half bridges. Fault detection could
be performed during a device daily self-test, or it could be done
in real-time during the shock (e.g. if a short circuit is suddenly
detected).
[0069] If four electrodes are applied to the patient it is possible
to use one set of pads as a backup in case there is a problem with
the other pads. The switch to the backup could be done if one
vector is insufficient to defibrillate or could be done if a fault
is detected with one path.
[0070] External Defibrillator Embodiments
[0071] A wearable defibrillator system made according to
embodiments has a number of components. One of these components is
a support structure, which is configured to be worn by the patient.
The support structure can be any structure suitable for wearing,
such as a harness, a vest, one or more belts, another garment, and
so on. The support structure can be implemented in a single
component, or multiple components. For example, a support structure
may have a top component resting on the shoulders, for ensuring
that the defibrillation electrodes will be in the right place for
defibrillating, and a bottom component resting on the hips, for
carrying the bulk of the weight of the defibrillator. A single
component embodiment could be with a belt around at least the
torso. Other embodiments could use an adhesive structure or another
way for attaching to the person, without encircling any part of the
body. There can be other examples.
[0072] FIGS. 5A and 5B depict examples of a defibrillation system.
FIG. 5A is a schematic rendering and FIG. 5B depicts an
illustrative example of a wearable defibrillator. The left side of
FIG. 5B shows the system itself and the right side shows the system
being worn by a patient. As shown, with a wearable defibrillator,
the patient wears the garment, which holds the electrodes in place
and also has a manner of wearing or carrying the defibrillator with
them. A multivector waveform is particularly suitable for a
wearable defibrillator because the person can put on a single
garment that includes multiple electrodes.
[0073] Referring to FIG. 5A, a person 582 is lying on his back.
Person 582 could be a patient in a hospital, or someone found
unconscious, and then turned to be on their back. Person 582 is
experiencing a condition in his heart 585, which could be, e.g.,
ventricular fibrillation or the like. A portable external
defibrillator 500 has been brought close to person 582. At least
two defibrillation electrodes 504, 508 are usually provided with
external defibrillator 500, and are sometimes called electrodes
504, 508. Electrodes 504, 508 are coupled with external
defibrillator 500 via respective electrode leads 505. A rescuer
(not shown) has attached electrodes 504, 508 to the skin of person
582. Defibrillator 500 is administering, via electrodes 504, 508, a
brief, strong electric pulse 511 through the body of person 582.
Pulse 511, also known as a defibrillation shock, goes also through
heart 585, in an attempt to restart it, for saving the life of
person 582. It should be noted that, in accordance with a presently
preferred embodiment, the external defibrillator of FIG. 5A may
include three or more electrodes strategically placed in a wearable
garment to enable the application of a multivector shock protocol
in accordance with the teachings of the present application. For
example, a suitable configuration for humans would be a four
electrode configuration with two pads in standard apex-sternum
positions along with two electrodes in standard anterior-posterior
positions.
[0074] Defibrillator 500 can be one of different types, each with
different sets of features and capabilities. The set of
capabilities of defibrillator 500 is determined by planning who
would use it, and what training they would be likely to have.
[0075] FIG. 6 depicts a table listing three main types of external
defibrillators, how they are applied, interpreted, and configured
for therapy delivery. A first type of defibrillator 500 is
generally called a defibrillator-monitor, because it is typically
formed as a single unit in combination with a patient monitor. A
defibrillator-monitor is sometimes called monitor-defibrillator. A
defibrillator-monitor is intended to be used by persons in the
medical professions, such as doctors, nurses, paramedics, emergency
medical technicians, etc. Such a defibrillator-monitor can be used
in a pre-hospital or hospital scenario. As a defibrillator, the
device can be one of different varieties, or even versatile enough
to be able to switch among different modes that individually
correspond to the varieties. One variety is that of an automated
defibrillator, which can determine whether a shock is needed and,
if so, charge to a predetermined energy level and instruct the user
to administer the shock. Another variety is that of a manual
defibrillator, where the user determines the need and controls
administering the shock. As a patient monitor, the device has
features additional to what is minimally needed for mere operation
as a defibrillator. These features can be for monitoring
physiological indicators of a person in an emergency scenario.
These physiological indicators are typically monitored as signals.
For example, these signals can include a person's full ECG
(electrocardiogram) signals, or impedance between two electrodes.
Additionally, these signals can be about the person's temperature,
non-invasive blood pressure (NIBP), arterial oxygen
saturation/pulse oximetry (SpO2), the concentration or partial
pressure of carbon dioxide in the respiratory gases, which is also
known as capnography, and so on. These signals can be further
stored and/or transmitted as patient data.
[0076] A second type of external defibrillator 500 is generally
called an AED, which stands for "Automated External Defibrillator".
An AED typically makes the shock/no shock determination by itself,
automatically. Indeed, it can sense enough physiological conditions
of the person 582 via only the shown defibrillation electrodes 504,
508. In some embodiments, an AED can either administer the shock
automatically, or instruct the user to do so, e.g. by pushing a
button. Being of a much simpler construction, an AED typically
costs much less than a defibrillator-monitor. As such, it makes
sense for a hospital, for example, to deploy AEDs at its various
floors, in case the more expensive defibrillator-monitor is more
critically being deployed at an Intensive Care Unit, and so on.
AEDs, however, can also be used by people who are not in the
medical profession. More particularly, an AED can be used by many
professional first responders, such as policemen, firemen, etc.
Even a person with only first-aid training can use one. And AEDs
increasingly can supply instructions to whoever is using them. AEDs
are thus particularly useful, because it is so critical to respond
quickly, when a person suffers from VF. Indeed, the people who will
first reach the VF sufferer may not be in the medical
professions.
[0077] Increasing awareness has resulted in AEDs being deployed in
public or semi-public spaces, so that even a member of the public
can use one, if they have obtained first aid and CPR/AED training
on their own initiative. This way, defibrillation can be
administered soon enough after the onset of VF, to hopefully be
effective in rescuing the person.
[0078] A third type of defibrillator is a wearable defibrillator.
It is prescribed by a physician, is worn by the patient, and
applies therapy automatically in case of cardiac arrest.
[0079] There are additional types of external defibrillators, which
are not listed in FIG. 6. For example, a hybrid defibrillator can
have aspects of an AED, and also of a defibrillator-monitor. A
usual such aspect is additional ECG monitoring capability.
[0080] FIG. 7 depicts a diagram showing possible components of an
external defibrillator 700 made according to an embodiment of the
present invention. These components can be, for example, in
external defibrillator 500 of FIGS. 5A and 5B. In addition, these
components of FIG. 7 can be provided in a housing 701, which is
also known as casing 701.
[0081] External defibrillator 700 is intended for use by a user
780, who would be the rescuer. Defibrillator 700 typically includes
a defibrillation port 710, such as a socket in housing 701.
Defibrillation port 710 includes internal nodes (not shown).
Defibrillation electrodes 704 (including electrode pads A-D), which
can be similar to electrodes 504, 508, can be plugged in
defibrillation port 710, so as to make electrical contact with the
nodes. It is also possible that electrodes can be connected
continuously to defibrillation port 710, etc. Either way,
defibrillation port 710 can be used for guiding via electrodes to
person 582 an electrical charge that has been stored in
defibrillator 700 (i.e., in capacitor 752), as discussed below.
[0082] If defibrillator 700 is actually a defibrillator-monitor,
then it will typically also have an ECG port 719 in housing 701,
for plugging in ECG leads 709. ECG leads 709 can help sense an ECG
signal, e.g. a 12-lead signal, or from a different number of leads.
Moreover, a defibrillator-monitor could have additional ports (not
shown), and another component 725 structured to filter the ECG
signal, e.g., apply at least one filter to the signal so as to
remove chest compression artifacts resulting from chest
compressions being delivered to the person 582.
[0083] Defibrillator 700 may also include a measurement circuit
720. Measurement circuit 720 receives physiological signals from
ECG port 719, and also from other ports, if provided. These
physiological signals are sensed, and information about them is
rendered by circuit 720 as data, or other signals, etc.
[0084] If defibrillator 700 is actually an AED, it may lack ECG
port 719. Measurement circuit 720 can obtain physiological signals
through the nodes within port 710 instead, when defibrillation
electrodes 704 are attached to person 582 (FIG. 5). In these cases,
a person's ECG signal can be sensed as a voltage difference between
electrodes 704. Plus, impedance between electrodes 704 can be
sensed for detecting, among other things, whether these electrodes
have been inadvertently disconnected from the person.
[0085] Defibrillator 700 also includes a processor 730. Processor
730 may be implemented in any number of ways, for causing actions
and operations to be performed. Such ways include, by way of
example and not of limitation, digital and/or analog processors
such as microprocessors and digital-signal processors (DSPs);
controllers such as microcontrollers; software running in a
machine; programmable circuits such as Field Programmable Gate
Arrays (FPGAs), Field-Programmable Analog Arrays (FPAAs),
Programmable Logic Devices (PLDs), Application Specific Integrated
Circuits (ASICs), any combination of one or more of these, and so
on.
[0086] Processor 730 can be considered to have a number of modules.
One such module can be a detection module 732, which senses outputs
of measurement circuit 720. Detection module 732 can include a VF
detector. Thus, the person's sensed ECG can be used to determine
whether the person is experiencing VF.
[0087] Another such module in processor 730 can be an advice module
734, which arrives at advice based on outputs of detection module
732. Advice module 734 can include a Shock Advisory Algorithm,
implement decision rules, and so on. The advice can be to shock, to
not shock, to administer other forms of therapy, and so on. If the
advice is to shock, some external defibrillator embodiments merely
report that to the user, and prompt them to do it. Other
embodiments further execute the advice, by administering the shock.
If the advice is to administer CPR, defibrillator 700 may further
issue prompts for it, and so on. Processor 730 can include
additional modules, such as module 736, for other functions. In
addition, if other component 725 is indeed provided, it may be
operated in part by processor 730, etc.
[0088] Defibrillator 700 optionally further includes a memory 738,
which can work together with processor 730. Memory 738 may be
implemented in any number of ways. Such ways include, by way of
example and not of limitation, nonvolatile memories (NVM),
read-only memories (ROM), random access memories (RAM), any
combination of these, and so on. Memory 738, if provided, can
include programs for processor 730, and so on. The programs can be
operational for the inherent needs of processor 730, and can also
include protocols and ways that decisions can be made by advice
module 734. In addition, memory 738 can store prompts for user 780,
etc. Moreover, memory 738 can store patient data.
[0089] Defibrillator 700 may also include a power source 740. To
enable portability of defibrillator 700, power source 740 typically
includes a battery. Such a battery is typically implemented as a
battery pack, which can be rechargeable or not. Sometimes, a
combination is used, of rechargeable and non-rechargeable battery
packs. Other embodiments of power source 740 can include AC power
override, for where AC power will be available, and so on. In some
embodiments, power source 740 is controlled by processor 730.
[0090] Defibrillator 700 additionally includes an energy storage
module 750. Module 750 is where electrical energy is stored, when
preparing it for sudden discharge to administer a shock. Module 750
can be charged from power source 740 to the right amount of energy,
as controlled by processor 730. In typical implementations, module
750 includes one or more capacitors 752, and so on.
[0091] Defibrillator 700 moreover includes a discharge circuit 755.
Circuit 755 can be controlled to permit the energy stored in module
750 to be discharged to the nodes within defibrillation port 710,
and thus also to defibrillation electrodes 704. Circuit 755 can
include one or more switches, half-bridges, or the like, as
discussed above with reference to FIG. 2.
[0092] Defibrillator 700 further includes a user interface 770 for
user 780. User interface 770 can be made in any number of ways. For
example, interface 770 may include a screen, to display what is
detected and measured, provide visual feedback to the rescuer for
their resuscitation attempts, and so on. Interface 770 may also
include a speaker, to issue voice prompts, etc. Interface 770 may
additionally include various controls, such as pushbuttons,
keyboards, and so on. In addition, discharge circuit 755 can be
controlled by processor 730, or directly by user 780 via user
interface 770, and so on.
[0093] Defibrillator 700 can optionally include other components.
For example, a communication module 790 may be provided for
communicating with other machines. Such communication can be
performed wirelessly, or via wire, or by infrared communication,
and so on. This way, data can be communicated, such as patient
data, incident information, therapy attempted, CPR performance, and
so on.
[0094] A feature of a defibrillator can be CPR-prompting. Prompts
are issued to the user, visually or by sound, so that the user can
administer CPR. Examples are taught in U.S. Pat. Nos. 6,334,070 and
No. 6,356,785.
Conclusion
[0095] Conditional language used herein, such as, among others,
"can," "could," "might," "may," "e.g.," and the like, unless
specifically stated otherwise, or otherwise understood within the
context as used, is generally intended to convey that certain
examples include, while other examples do not include, certain
features, elements, and/or steps. Thus, such conditional language
is not generally intended to imply that features, elements and/or
steps are in any way required for one or more examples or that one
or more examples necessarily include logic for deciding, with or
without author input or prompting, whether these features, elements
and/or steps are included or are to be performed in any particular
example. The terms "comprising," "including," "having," and the
like are synonymous and are used inclusively, in an open-ended
fashion, and do not exclude additional elements, features, acts,
operations, and so forth. Also, the term "or" is used in its
inclusive sense (and not in its exclusive sense) so that when used,
for example, to connect a list of elements, the term "or" means
one, some, or all of the elements in the list.
[0096] In general, the various features and processes described
above may be used independently of one another, or may be combined
in different ways. For example, this disclosure includes other
combinations and sub-combinations equivalent to: extracting an
individual feature from one embodiment and inserting such feature
into another embodiment; removing one or more features from an
embodiment; or both removing a feature from an embodiment and
adding a feature extracted from another embodiment, while providing
the advantages of the features incorporated in such combinations
and sub-combinations irrespective of other features in relation to
which it is described. All possible combinations and
subcombinations are intended to fall within the scope of this
disclosure. In addition, certain method or process blocks may be
omitted in some implementations. The methods and processes
described herein are also not limited to any particular sequence,
and the blocks or states relating thereto can be performed in other
sequences that are appropriate. For example, described blocks or
states may be performed in an order other than that specifically
disclosed, or multiple blocks or states may be combined in a single
block or state. The example blocks or states may be performed in
serial, in parallel, or in some other manner. Blocks or states may
be added to or removed from the disclosed example examples. The
example systems and components described herein may be configured
differently than described. For example, elements may be added to,
removed from, or rearranged compared to the disclosed example
examples.
[0097] Each of the processes, methods and algorithms described in
the preceding sections may be embodied in, and fully or partially
automated by, code modules executed by one or more computers or
computer processors. The code modules may be stored on any type of
non-transitory computer-readable medium or computer storage device,
such as hard drives, solid state memory, optical disc and/or the
like. The processes and algorithms may be implemented partially or
wholly in application-specific circuitry. The results of the
disclosed processes and process steps may be stored, persistently
or otherwise, in any type of non-transitory computer storage such
as, e.g., volatile or non-volatile storage.
[0098] It will also be appreciated that various items are
illustrated as being stored in memory or on storage while being
used, and that these items or portions of thereof may be
transferred between memory and other storage devices for purposes
of memory management and data integrity. Alternatively, in other
embodiments some or all of the software modules and/or systems may
execute in memory on another device and communicate with the
illustrated computing systems via inter-computer communication.
Furthermore, in some embodiments, some or all of the systems and/or
modules may be implemented or provided in other ways, such as at
least partially in firmware and/or hardware, including, but not
limited to, one or more application-specific integrated circuits
(ASICs), standard integrated circuits, controllers (e.g., by
executing appropriate instructions, and including microcontrollers
and/or embedded controllers), field-programmable gate arrays
(FPGAs), complex programmable logic devices (CPLDs), etc. Some or
all of the modules, systems and data structures may also be stored
(e.g., as software instructions or structured data) on a
computer-readable medium, such as a hard disk, a memory, a network
or a portable media article to be read by an appropriate drive or
via an appropriate connection. Such computer program products may
also take other forms in other embodiments. Accordingly, the
present invention may be practiced with other computer system
configurations.
[0099] While certain example or illustrative examples have been
described, these examples have been presented by way of example
only, and are not intended to limit the scope of the inventions
disclosed herein. Indeed, the novel methods and systems described
herein may be embodied in a variety of other forms. The
accompanying claims and their equivalents are intended to cover
such forms or modifications as would fall within the scope and
spirit of certain of the inventions disclosed herein.
* * * * *