U.S. patent application number 10/224689 was filed with the patent office on 2003-01-02 for defibrillation system.
Invention is credited to Fincke, Randall W., O'Leary, James P., Owen, James M., Totman, Mark H..
Application Number | 20030004547 10/224689 |
Document ID | / |
Family ID | 26712993 |
Filed Date | 2003-01-02 |
United States Patent
Application |
20030004547 |
Kind Code |
A1 |
Owen, James M. ; et
al. |
January 2, 2003 |
Defibrillation system
Abstract
A method of treating a patient for ventricular tachycardia using
a wearable defibrillator includes monitoring the patient for a
predetermined condition via one or more electrodes on the
defibrillator, sending a message to the patient in response to the
predetermined condition, activating the defibrillator so that the
defibrillator delivers defibrillation energy to the patient, and
storing at least one of the results of the monitoring, sending and
activating steps in a memory on the defibrillator. The method also
includes downloading information stored in the memory of the
defibrillator to a base station having an external interface, and
transmitting the information downloaded from the memory of the base
station to an external location via the external interface of the
base station.
Inventors: |
Owen, James M.; (Waltham,
MA) ; Fincke, Randall W.; (Winchester, MA) ;
O'Leary, James P.; (Meford, MA) ; Totman, Mark
H.; (Winchester, MA) |
Correspondence
Address: |
GOTTLIEB RACKMAN & REISMAN PC
270 MADISON AVENUE
8TH FLOOR
NEW YORK
NY
100160601
|
Family ID: |
26712993 |
Appl. No.: |
10/224689 |
Filed: |
August 21, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10224689 |
Aug 21, 2002 |
|
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|
09652054 |
Aug 31, 2000 |
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Current U.S.
Class: |
607/5 |
Current CPC
Class: |
A61N 1/046 20130101;
A61N 1/3993 20130101; A61N 1/0492 20130101; A61N 1/3918 20130101;
A61N 1/0496 20130101; A61N 1/3904 20170801; A61N 1/3925 20130101;
A61N 1/0468 20130101; A61N 1/3937 20130101; A61N 1/0456 20130101;
A61N 1/3987 20130101; A61N 1/0476 20130101; A61N 1/0472 20130101;
A61N 1/0452 20130101 |
Class at
Publication: |
607/5 |
International
Class: |
A61N 001/39 |
Claims
What is claimed is:
1. A wearable defibrillator adapted to deliver defibrillation
energy to a patient, the wearable defibrillator comprising: at
least one electrode having a conductive surface in contact with the
patient's skin, the at least one electrode being adapted for
long-term wear on the patient.
2. A wearable defibrillator according to claim 1, wherein the at
least one electrode comprises one or more of the following types of
electrodes: a segmented electrode, a low-surface area electrode, a
traditional defibrillation electrode, and a subcutaneous
electrode.
3. A wearable defibrillator according to claim 1, wherein the at
least one electrode is wearable for a period of greater than one
week.
4. A wearable defibrillator according to claim 1, wherein the at
least one electrode includes electrically-conductive hydrogel at a
surface thereof with contacts to the patient's skin, the
electrically-conductive hydrogel having a predetermined ion
concentration.
5. A wearable defibrillator according to claim 4, wherein the
electrically-conductive hydrogel includes a therapeutic agent which
promotes skin health.
6. A wearable defibrillator according to claim 1, wherein the at
least one electrode includes a mesh at a surface thereof which
contacts to the patient's skin.
7. A wearable defibrillator according to claim 1, wherein the at
least one electrode is periodically movable to different positions
on the patient.
8. A wearable defibrillator for delivering defibrillation energy to
a patient, the defibrillator comprising: at least one electrode
which attaches to the patient for transmitting the defibrillation
energy to the patient and for receiving patient information from
the patient; a plurality of capacitors which are switchable so as
to alter characteristics of the defibrillation energy; and a
controller which controls switching of the plurality of capacitors
in accordance with the patient information received from the at
least one electrode.
9. A wearable defibrillator according to claim 8, wherein the
patient information comprises a thoracic impedance of the
patient.
10. A wearable defibrillator according to claim 9, wherein the
thoracic impedance is determined periodically by applying an AC
signal through the at least one electrode, sampling data obtained
from the at least one electrode in response to the AC signal, and
analyzing the sampled data.
11. A wearable defibrillator according to claim 9, wherein the
thoracic impedance is calculated each time the defibrillation
energy is transmitted to the patient based on patient information
received from the at least one electrode in response to the
defibrillation energy.
12. A wearable defibrillator according to claim 9, wherein the
controller controls switching of the capacitors in a case that the
thoracic impedance of the patient is within a predetermined
range.
13. A wearable defibrillator according to claim 8, wherein the
patient information comprises an electrocardiogram of the
patient.
14. A wearable defibrillator according to claim 13, wherein the
controller controls switching of the capacitors in a case that the
electrocardiogram indicates a cardiac arrhythmia and in a case that
the patient is unconscious.
15. A wearable defibrillator according to claim 8, wherein the
patient information comprises electrode-to-skin impedance, the
electrode-to-skin impedance being used to determine connection of
the at least one electrode to the patient.
16. A wearable defibrillator according to claim 8, wherein the
patient information comprises artifact noise in the patient's
body.
17. A wearable defibrillator according to claim 8, further
comprising a memory which stores the patient parameter, the patient
parameters comprising at least one of the patient's name; the
language used for voice and corresponding text messages; a minimum
audio level to which a patient responds a minimum tactile
stimulation signal to which a patient responds, a maximum tactile
stimulation signal for a patient, a pacing bradycardia rate, a pace
current level, the patient's ID number, a ventricular tachycardia
rate at which defibrillation energy is to be delivered to the
patient, the patient's thoracic impedance range, a time and a date
at which the defibrillator was issued to the patient, a name of a
clinic at an external location, a name of a clinician at the
external location, and an electrode-to-skin impedance range;
wherein the controller controls switching of the plurality of
capacitors also in accordance with the patient parameters.
18. A wearable defibrillator according to claim 8, wherein the
plurality of capacitors comprises five capacitors; and wherein the
five capacitors are switchable in configurations of 221, 2111 and
1111.
19. A wearable defibrillator according to claim 8, wherein the at
least one electrode is capable of transmitting a tactile
stimulation signal from at least one of the plurality of capacitors
to the patient.
20. A wearable defibrillator according to claim 19, wherein the
tactile stimulation signal is transmitted to the patient in a case
that the patient information indicates that the patient has
suffered a cardiac arrhythmia.
21. A wearable defibrillator according to claim 8, wherein the
wearable defibrillator includes a floating ground.
22. A wearable defibrillator for delivering defibrillation energy
to a patient, the defibrillator comprising: at least one electrode
which attaches to the patient for transmitting the defibrillation
energy to the patient; and a signal generator for generating the
defibrillation energy, wherein the defibrillation energy has a
bi-phasic waveform with a peak amplitude that is below 23 amperes
for a patient having a thoracic impedance which is at least 40
ohms.
23. A wearable defibrillator according to claim 22, wherein the
bi-phasic waveform includes two phases having substantially
identical durations.
24. A wearable defibrillator according to claim 22, wherein the
bi-phasic waveform includes two phases in which a first phase has a
duration which is greater than a duration of the second phase.
25. A wearable defibrillator according to claim 23, wherein the at
least one electrode receives information from the patient which
indicates a thoracic impedance of the patient; and wherein the
signal generator varies the peak amplitude of the defibrillation
energy in accordance with the thoracic impedance of the
patient.
26. A wearable defibrillator according to claim 25, wherein the
signal generator comprises a plurality of capacitors which are
switchable in order to affect the amplitude of the defibrillation
energy.
27. A wearable defibrillator according to claim 26, further
comprising a resistor in series with the plurality of
capacitors.
28. A wearable defibrillator according to claim 23, wherein an
average amplitude of the defibrillation energy is below 17 amperes
for a patient having a thoracic impedance which is at least 40
ohms.
29. A wearable defibrillator according to claim 23, wherein the
bi-phasic waveform is truncated and delivered within a
predetermined time period.
30. A wearable defibrillator according to claim 22, wherein each of
electrode has a surface area which is less than 60 cm.sup.2.
31. A wearable defibrillator according to claim 22, wherein each
electrode has a surface area which is less than 50 cm.sup.2.
32. A wearable defibrillator according to claim 22, wherein each
electrode has a surface area which is less than 40 cm.sup.2.
33. A wearable defibrillator according to claim 22, wherein each
electrode has a surface area which is less than 30 cm.sup.2.
34. A wearable defibrillator for delivering defibrillation energy
to a patient, the defibrillator comprising: a signal generator for
generating the defibrillation energy; and a plurality of segmented
electrodes each having a conductive area for transmitting the
defibrillation energy to the patient, wherein the plurality of
segmented electrodes are divided into groups of two or more
electrodes, each of the groups of electrodes having at least one
line connected to the signal generator, each line having a length
sufficient for each group of electrodes to be placed on the patient
a predetermined distance away from others of the groups of
electrodes, the electrodes in at least one of the groups being
spatially arranged to have an effective conductive area which is
greater than a total combined conductive area of the electrodes in
the group.
35. A wearable defibrillator according to claim 34, further
comprising a plurality of non-electrically conductive pads; wherein
each of the groups of two or more electrodes is mounted on one of
the plurality of non-electrically conductive pads such that each
electrode in the group of electrodes is mounted a predetermined
distance away from at least one other electrode in the group of
electrodes.
36. A wearable defibrillator according to claim 35, wherein each
electrode in the groups of electrodes includes
electrically-conductive hydrogel at a surface thereof with contacts
to the patient's skin, the electrically-conductive hydrogel having
a predetermined ion concentration.
37. A wearable defibrillator according to claim 36, wherein each
non-electrically conductive pad includes therapeutic hydrogel at a
surface thereof which contacts to the patient's skin.
38. A wearable defibrillator according to claim 35, wherein each
non-electrically conductive pad is flexible.
39. A wearable defibrillator according to claim 34, wherein the
groups of electrodes are arrangeable on different areas of the
patient in predetermined geometric patterns such that the
defibrillation energy transmitted from the plurality of electrodes
covers a predetermined area of the patient's myocardium.
40. A wearable defibrillator according to claim 39, wherein the
groups of electrodes in predetermined geometric patterns are
movable relative to the patient such that the predetermined
geometric patterns are substantially retained but are at different
orientations relative to the patient.
41. A wearable defibrillator according to claim 34, wherein each of
the plurality of segmented electrodes is shaped so that each
electrode has a perimeter which is greater than a circumference
corresponding to a radius of the electrode.
42. A wearable defibrillator according to claim 34, wherein the
signal generator includes a power supply which supplies power to
the signal generator so as to enable the signal generator to
generate the defibrillation energy; and wherein each line
corresponding to each group of electrodes is non-removably
connected to the power supply.
43. A wearable defibrillator according to claim 42, wherein the
power supply is sealed with a membrane.
44. A wearable defibrillator according to claim 34, further
comprising: a speaker for providing auditory messages to the
patient; and a controller for monitoring each of the segmented
electrodes; wherein the controller monitors a duration of use of
each of the segmented electrodes and, when the controller
determines that an electrode has been in use for greater than a
predetermined period of time, the controller issues a signal to the
speaker alerting the patient which electrode has been in use for
greater than the predetermined period of time.
45. A wearable defibrillator according to claim 34, wherein each of
the plurality of segmented electrodes is capable of transmitting
defibrillation energy having a bi-phasic waveform.
46. A wearable defibrillator according to claim 34, wherein each of
the plurality of segmented electrodes is capable of transmitting
defibrillation energy having a truncated exponential waveform.
47. A wearable defibrillator according to claim 34, wherein each of
the plurality of segmented electrodes is capable of transmitting
defibrillation energy having a mono-phasic waveform.
48. A wearable defibrillator according to claim 34, wherein the
segmented electrodes are separated from each other on the patient
by between 0.5 and 3 times an effective diameter of each
electrode.
49. A wearable defibrillator according to claim 34, wherein each of
the segmented electrodes includes an adhesive on a surface thereof
which contacts the patient's skin.
50. A wearable defibrillator for delivering defibrillation energy
to a patient, the defibrillator comprising: an external interface,
over which patient information is transmitted to an external
location; a patient interface, over which the defibrillation energy
is transmitted to the patient, and over which the patient
information is received; a processor which analyzes the patient
information received over the patient interface and which controls
transmission of the defibrillation energy to the patient based on
at least a first portion of the patient information; and a memory
which stores at least a second portion of the patient information
prior to transmission of the second portion of the patient
information over the external interface.
51. A wearable defibrillator according to claim 50, wherein the
external interface is capable of interfacing to a base station, the
base station for receiving the second portion of the patient
information from the memory and for transmitting defibrillator
programming information to the defibrillator via the external
interface, the processor using the defibrillator programming
information to reprogram the wearable defibrillator.
52. A wearable defibrillator according to claim 51, further
comprising a power supply which supplies power to the wearable
defibrillator and which is capable of interfacing to the external
interface.
53. A wearable defibrillator according to claim 50, wherein the at
least the second portion of the patient information comprises a
log, for a predetermined period, which includes at least one of
abnormal heart activity of the patient, an electrocardiogram of the
patient, and artifact noise in the patient.
54. A wearable defibrillator according to claim 53, further
comprising a user interface by which the user interacts with the
wearable defibrillator; wherein the memory further stores a
response of the wearable defibrillator to the abnormal heart
activity and information concerning patient interaction with the
wearable defibrillator.
55. A wearable defibrillator according to claim 54, further
comprising an accelerometer which the processor monitors to
determine motion of the patient; wherein the memory further stores
data from the accelerometer relating to motion of the patient.
56. A wearable defibrillator according to claim 55, wherein the
processor detects defibrillator operational errors and stores the
defibrillator operational errors in the memory; wherein the
external interface is capable of interfacing to both a base station
and a power supply; and wherein, in a case that the external
interface is interfaced to the base station, the processor
transmits, over the external interface, the abnormal heart activity
of the patient, the electrocardiogram of the patient, the artifact
noise in the patient, the response of the wearable defibrillator to
the abnormal heart activity, the information concerning patient
interaction with the wearable defibrillator, the data from the
accelerometer relating to motion of the patient, and the
defibrillator operational errors.
57. A wearable defibrillator according to claim 50, wherein the
external interface comprises a non-contact interface over which the
patient information is transmitted to a personal computer.
58. A wearable defibrillator according to claim 57, wherein the
patient information comprises an electrocardiogram and impedance
information for the patient.
59. A wearable defibrillator according to claim 57, wherein the
non-contact interface comprises an infrared ("IR") interface.
60. A wearable defibrillator according to claim 57, wherein the
non-contact interface comprises a radio frequency ("RF")
interface.
61. A wearable defibrillator according to claim 50, wherein the
memory comprises a flash EPROM; and wherein the second portion of
the patient information is stored in the flash EPROM as compressed
data.
62. A wearable defibrillator according to claim 61, wherein the
processor compresses data using a lossless compression
technique..
63. A wearable defibrillator according to claim 50, wherein the
patient interface comprises a plurality of sensing electrodes, the
defibrillation energy has a bi-phasic waveform that is transmitted
over each of the sensing electrodes, the first patient information
comprises an electrocardiogram and thoracic impedance of the
patient, and the second patient information comprises an
operational history of the wearable defibrillator; and wherein both
the first patient information and the second patient information
are stored in the memory and both the first patient information and
the second patient information are transmitted over the external
interface.
64. A wearable defibrillator according to claim 50, further
comprising one or more indicators which provide the patient with
indications relating to at least one of the patient information and
operability of the wearable defibrillator.
65. A wearable defibrillator according to claim 64, wherein the one
or more indicators comprises an auditory indicator which provides
the patient with auditory prompts for using the wearable
defibrillator.
66. A wearable defibrillator according to claim 65, wherein at
least one of the auditory prompts is provided in a case that the
processor analyzes the patient information and determines that
abnormal heart activity has occurred in the patient.
67. A wearable defibrillator according to claim 66, further
comprising a user interface for providing a response signal to the
processor in response to user activation; wherein the processor
waits a predetermined period of time after the at least one of the
auditory prompts has been provided to the patient and, in a case
that the processor does not detect the response signal, the
processor causes immediate transmission of the defibrillation
energy to the patient.
68. A wearable defibrillator according to claim 65, wherein the
patient interface comprises one or more sensing electrodes which
are attached to the patient; wherein the patient information
comprises electrode-to-skin impedance from the patient, the
electrode-to-skin impedance from the patient being indicative of
whether the one or more sensing electrodes is attached to the
patient; and wherein the processor causes the auditory indicator to
provide an indication to the patient that the at least one
electrode has become detached in a case that the electrode-to-skin
impedance from the patient is below a predetermined level.
69. A wearable defibrillator according to claim 65, further
comprising a power supply for supplying power to the wearable
defibrillator; wherein the processor monitors the power supply and
causes the auditory indicator to provide an auditory message to the
patient in a case that the power supply is below a predetermined
level.
70. A wearable defibrillator according to claim 64, wherein the one
or more indicators comprises a visual display and an auditory
indicator which echos information displayed on the visual
display.
71. A wearable defibrillator according to claim 50, further
comprising a user interface for providing a response signal to the
processor in response to user activation; wherein the patient
interface comprises at least one electrode which is capable of
transmitting a tactile stimulation signal to the patient; and
wherein the processor waits a predetermined period of time after
the tactile stimulation signal has been transmitted to the patient
and, in a case that the processor does not detect the response
signal, the processor causes transmission of the defibrillation
energy to the patient.
72. A wearable defibrillator for delivering defibrillation energy
to a patient, the defibrillator comprising: a patient interface,
over which patient information is received from the patient, and
over which the defibrillation energy is transmitted to the patient;
and a processor which operates in a normal mode and a low-power
consumption mode, wherein, during the normal mode, the processor
receives the patient information and controls transmission of the
defibrillation energy in accordance with the patient
information.
73. A wearable defibrillator according to claim 72, wherein the
processor enters the low-power consumption mode periodically for
predetermined periods of time.
74. A wearable defibrillator according to claim 73, wherein the
predetermined periods of time are variable based on the patient
information.
75. A wearable defibrillator according to claim 74, further
comprising a memory which stores a log of the patient information
for a span of time; wherein the processor varies the predetermined
periods based on the log of patient information stored in the
memory.
76. A wearable defibrillator according to claim 72, further
comprising a user interface by which a user may place the processor
in the normal mode manually.
77. A wearable defibrillator according to claim 72, further
comprising a plurality of hardware components for use in outputting
the defibrillation energy and for communicating with the patient;
wherein the processor causes each of the plurality of hardware
components to be selectively powered-up and powered-down at
predetermined time intervals.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention is directed to a defibrillation
device, and more particularly to a personal wearable
pacer/cardioverter/defibrillator which monitors a patient's
condition, detects shockable or paceable arrhythmias, determines
consciousness, and, in the case that the patient is determined to
be unconscious, administers therapy to the patient.
[0003] 2. Description of the Related Art
[0004] Cardiac arrhythmias, such as ventricular fibrillation and
ventricular tachycardia, are electrical malfunctions of the heart,
in which regular electrical impulses in the heart are replaced by
irregular, rapid impulses. These irregular, rapid impulses can
cause the heart to stop normal contractions, thereby interrupting
blood flow therethrough. Such an interruption in blood flow can
cause organ damage or even death.
[0005] Normal heart contractions, and thus normal blood flow, can
be restored to a patient through application of electric shock.
This procedure, which is called defibrillation, has proven highly
effective at treating patients with cardiac arrhythmias, provided
that it is administered within minutes of the arrhythmia. In the
past, this was not always possible, since defibrillation units were
large, and thus not easy to move, and could only be operated by an
experienced clinician.
[0006] In response to the foregoing drawbacks of defibrillation
units, implantable defibrillators were developed. Such
defibrillators, however, also have several drawbacks. Specifically,
use of a such a defibrillator requires surgery, thereby making
their use inconvenient and even undesirable under certain
circumstances. Moreover, implantable defibrillators are also
costly, both in terms of the device itself and in terms of the cost
of the surgery and subsequent treatments.
[0007] To address the foregoing drawbacks of implantable
defibrillators, portable automatic external defibrillators
(hereinafter "AEDs") were developed. These defibrillators are
typically used by trained emergency medical system personnel. The
major shortcoming of these defibrillators is the delay between the
onset of ventricular fibrillation and the administering of a first
shock. It has been estimated that survival decreases by 10% for
each minute that passes after the first minute of ventricular
fibrillation.
[0008] Temporary high risk patients who do not reach an ICD have
little protection against sudden cardiac arrest ("SDA"),
particularly with the discovery that anti-arrhythmia drugs have
been proven to be less effective than a placebo. Accordingly, there
exists a need for a defibrillator, preferably a portable, wearable
defibrillator, which addresses the foregoing drawbacks of
conventional defibrillators.
SUMMARY OF THE INVENTION
[0009] The present invention addresses the foregoing needs. For
example, according to one aspect, the present invention is a
defibrillator for delivering defibrillation energy to a patient.
The defibrillator includes at least one electrode which attaches to
the patient for transmitting the defibrillation energy to the
patient and for receiving patient information from the patient, and
a plurality of capacitors which are switchable so as to alter
characteristics of the defibrillation energy. According to the
invention, a controller controls switching of the plurality of
capacitors in accordance with the patient information received from
the at least one electrode.
[0010] By monitoring the patient for patient information and
switching the plurality of capacitors in accordance with the
patient information, the foregoing aspect of the invention makes it
possible to deliver, to the patient, defibrillation energy which is
appropriate for that patient. As a result, the invention provides
increased effectiveness in the treatment of cardiac
arrhythmias.
[0011] According to another aspect, the present invention is a way
in which to increase long-term wear of a sensing electrode, such as
a traditional defibrillation electrode (i.e., electrodes having a
conductive surface area of over 60 cm.sup.2), a low-surface-area
electrode (i.e., electrodes having a conductive surface area of
roughly 60 to 10 cm.sup.2), or segmented electrodes (i.e.,
electrodes having a conductive surface area of roughly 8 to 10
cm.sup.2). Specifically, the invention includes a variety of
different techniques for increasing the amount of time that an
electrode can be worn by a patient without resulting in substantial
skin irritation or damage. For example, according to one
embodiment, one or more electrodes are moved on the patient's body
periodically. As another example, therapeutic or prophylactic
agents are provided in or on the electrode. Also, the size,
configuration, and materials used to construct the electrodes
contribute the amount of time that the electrodes can be worn by a
patient.
[0012] According to another aspect, the present invention is a
defibrillator for delivering defibrillation energy to a patient.
The defibrillator includes a signal generator for generating the
defibrillation energy and a plurality of segmented electrodes each
having a conductive area for transmitting the defibrillation energy
to the patient. The plurality of segmented electrodes are divided
into groups of two or more electrodes, each of the groups of
electrodes having at least one line connected to the signal
generator. Each of the lines has a length that is sufficient for
each group of electrodes to be placed on the patient a
predetermined distance away from others of the groups of
electrodes. In the invention, the electrodes in at least one of the
groups are spatially arranged to have an effective conductive area
which is greater than a total combined conductive area of the
electrodes in the group.
[0013] According to still another aspect, the invention is a
segmented electrode device for use during ventricular fibrillation
of a patient. The segmented electrode device includes a plurality
of segmented electrodes each having a conductive area for
transmitting defibrillation energy to the patient. The plurality of
segmented electrodes are divided into groups of two or more
electrodes, each of the groups of electrodes having at least one
line connected to a signal generator. Each of the lines has a
length that is sufficient for each group of electrodes to be placed
on the patient a predetermined distance away from others of the
groups of electrodes. In the invention, the electrodes in at least
one of the groups are spatially arranged to have an effective
conductive area which is greater than a total combined conductive
area of the electrodes in the group.
[0014] By virtue of the electrode configurations in the foregoing
two aspects of the invention, it is possible to simulate a larger
conductive area using segmented electrodes. As a result, these
aspects of the invention have an advantage over their conventional
counterparts. That is, these aspects of the invention are able to
provide defibrillation energy to the patient without using large
electrodes. Thus, these aspects of the invention provide reduced
skin irritation without a corresponding reduction in efficacy.
[0015] According to another aspect, the present invention is a
defibrillator for delivering defibrillation energy to a patient.
The defibrillator includes an external interface, over which
patient information is transmitted to an external location, and a
patient interface, over which the defibrillation energy is
transmitted to the patient, and over which the patient information
is received. A processor is included in the defibrillator, which
analyzes the patient information received over the patient
interface and which controls transmission of the defibrillation
energy to the patient based on at least a first portion of the
patient information. A memory stores at least a second portion of
the patient information prior to transmission of the second portion
of the patient information over the external interface.
[0016] By controlling transmission of the defibrillation energy to
the patient based on at least a first portion of information
received from the patient, the invention is able to tailor the
defibrillation energy to the patient's needs. Moreover, because the
invention includes a memory which stores at least a second portion
of the patient information, and includes an external interface over
which such information may be transmitted, the invention is capable
of recording patient information, such as patient electrocardiogram
(hereinafter "ECG") information or the like for a period of time,
and of transmitting that patient information to an external
location, such as a central repository, hospital, doctor, etc.
[0017] According to another aspect, the present invention a
defibrillator for delivering defibrillation energy to a patient.
The defibrillator includes a processor and a patient interface,
over which patient information is received from the patient and
over which the defibrillation energy is transmitted to the patient.
The processor operates in a normal mode and a low-power consumption
mode, wherein, during the normal mode, the processor receives the
patient information and controls transmission of the defibrillation
energy in accordance with the patient information.
[0018] By having the processor operate in a low-power consumption
mode, the invention reduces the amount of power consumed by the
defibrillator. As a result, a power supply will last longer in the
defibrillator of the present invention than in its conventional
counterparts.
[0019] According to another aspect, the present invention is a
defibrillation system which includes a defibrillator for delivering
defibrillation energy to a patient and a base station connected to
the defibrillator. The defibrillator includes a plurality of
electrodes connected to the patient for transmitting defibrillation
energy to the patient and for receiving patient information from
the patient, and a memory which stores the patient information and
defibrillation information, the defibrillation information relating
to operation of the defibrillator. The defibrillator also includes
a base station interface, over which the patient information and
the defibrillation information are transmitted, and over which
external information is received, and a controller for controlling
when the defibrillation energy is transmitted to the patient based
on the patient information and at least part of the external
information. The base station includes a defibrillator interface
which mates to the base station interface of the defibrillator and
over which (i) the defibrillation information and the patient
information is received from the memory of the defibrillator, and
(ii) the external information is transmitted to the defibrillator.
The base station also includes an external interface, over which
the defibrillation information and the patient information is
transmitted to an external location. and over which the external
information is received from the external location.
[0020] By virtue of the foregoing arrangement, it is possible to
transmit patient and defibrillation information from a
defibrillator to a base station and from the base station to an
external location, such as a central repository, doctor, hospital,
etc. Moreover, the foregoing arrangement makes it possible to
transmit external information from the base station to the
defibrillator. This external information can be used, e.g., to
reprogram the defibrillator, to alert a patient to a possible
condition in the patient or the defibrillator, etc. In particularly
preferred embodiments of the invention, a memory on the
defibrillator containing patient and defibrillation information is
removable, and can be transferred to the base station or to an
external location for downloading.
[0021] According to another aspect, the present invention is a
defibrillation system which includes a defibrillator for delivering
predetermined defibrillation energy to a patient, an indicator
which indicates operational defects in the defibrillator, and a
base station which is interfaced to the defibrillator. The base
station performs diagnostics on the defibrillator in order to
detect operational defects in the defibrillator, and transmits
results of the diagnostics to the defibrillator. The indicator
provides an indication of such operational defects in the
defibrillator when the base station detects operational defects in
the defibrillator.
[0022] By alerting the patient to operational defects in the
defibrillator while the defibrillator is still in the base station,
this aspect of the invention is able to reduce the chances of
malfunction following a cardiac arrhythmia. As a result, this
aspect of the invention increases the patient's chances of
surviving an arrhythmia.
[0023] According to another aspect, the present invention is a
method of treating a patient for ventricular tachycardia,
bradycardia, ventricular fibrillation, or other treatable rhythm
using a pacer/converter/defibrill- ator in accordance with the
present invention (hereinafter referred to solely as a
"defibrillator"). The method includes monitoring the patient for a
predetermined condition via one or more electrodes on the
defibrillator, sending a message to the patient in response to the
predetermined condition, activating the defibrillator so that the
defibrillator delivers defibrillation energy to the patient, and
storing at least one of the results of the monitoring, sending and
activating steps in a memory on the defibrillator. The method also
includes downloading information stored in the memory of the
defibrillator to a base station having an external interface, and
transmitting the information downloaded from the memory of the base
station to an external location via the external interface of the
base station.
[0024] By sending a message to the patient in response to the
predetermined condition, by processing the patient's response, and
by other consciousness detection methods, the present invention is
able to reduce the chances of defibrillation energy being delivered
to the patient while the patient is still conscious. Moreover, the
foregoing aspect of the invention is able to store at least some
information relating to the arrhythmia and the patient's response
thereto, and to download that information to a base station, from
whence the information may be transmitted to an external location
for analysis or the like.
[0025] In this regard, according to another aspect, the present
invention is a base station for use with a defibrillator. The base
station includes a defibrillator interface over which information
is exchanged with the defibrillator, an external interface over
which information is exchanged with an external entity, and a
controller. The controller (i) receives patient information and
defibrillation information from the defibrillator, (ii) transmits
the patient information and defibrillation information to the
external entity, (iii) receives defibrillator programming
information from the external entity, (iv) programs the
defibrillator in accordance with the defibrillator programming
information, (v) performs diagnostics on the defibrillator, and
(vi) transmits results of the diagnostics to at least one of the
defibrillator and the external entity.
[0026] Thus, the base station of the present invention may both act
as an interface between a defibrillator and an external entity and
provide a patient with a means to ensure proper operation of the
defibrillator.
[0027] According to another aspect, the present invention is a
method for reprogramming a defibrillator based on a central
database of information relating to patients that use a type of
defibrillator. The method includes collecting, in the central
database, information relating to a plurality of patients that use
the type of defibrillator, analyzing the information stored in the
central database so as to test an algorithm for detecting irregular
heart activity, and correcting the algorithm for detecting
irregular heart activity based on a result of the analyzing
process. The method also includes transmitting a corrected
algorithm to a plurality of base stations corresponding to the
plurality of patients, and reprogramming a defibrillator in each of
the base stations using the corrected algorithm.
[0028] By providing a way in which to test algorithms for detecting
irregular heart activity, a way in which to correct such
algorithms, and a way in which to reprogram a defibrillator with a
corrected algorithm, the present invention is able to improve its
performance over time.
[0029] In preferred embodiments, the invention features a long-term
cardiac monitoring and defibrillation system that is wearable by a
patient. The system includes at least two electrode arrays
electrically connected to a portable defibrillator. The electrode
arrays are spatially separated and adhered to portions of the
patient's skin in the thoracic window area for an extended period
of time, such that electrical activity of the heart can be
monitored and effective defibrillation and/or pacing impulses can
be delivered to the patient's heart. The electrode arrays comprise
plural electrodes which are capable of sensing the patient's heart
condition by detecting the electrical activity of the heart, and of
delivering defibrillation or pacing impulses to the patient's heart
when required.
[0030] In another aspect, the cardiac monitoring and defibrillation
system of the invention comprises features which enhances the
long-term wearability of the system. These features include use of
a low-current defibrillation waveform and electrodes having a
composition and/or geometric design adapted to minimize the area of
the electrodes. In this regard, it has been determined that use of
a lower current than that typically used for defibrillation can
provided effective defibrillation, particularly when coupled with
electrode arrays having electrode surface areas which are
significantly smaller than the surface area of conventional
defibrillation electrodes. The use of reduced area electrodes
minimizes irritation to the skin. These features also permit higher
impedance materials to be used in the electrodes, which is also
less irritating to the patient's skin.
[0031] In one aspect, the electrode array comprises multiple
spatially separated electrodes separated by non-conductive
material, passive material or free space. The use of multiple
smaller electrodes minimizes the electrode area in contact with the
skin needed to deliver an effective defibrillation impulse to the
heart, thereby reducing the area of skin in contact with electrode
materials.
[0032] Another aspect of the invention features a long term cardiac
monitoring and defibrillation system and method that ameliorates,
reduces or prevents irritation of the patient's skin caused by
delivery of defibrillation impulses and/or by the constant contact
of the electrodes with the skin. According to this aspect, skin
that becomes irritated from contact with the electrodes is
permitted to recover by periodically detaching the electrode arrays
and moving or rotating them by a predetermined amount, and
re-affixing either the same or new electrode arrays to different
portions of the skin within the patient's thoracic window area.
This moving or rotating allows substantially different sections of
the patient's skin to be in contact with the electrodes so that
portions of the skin previously in contact with the electrodes are
allowed to recover.
[0033] The electrode arrays of the present invention preferably are
designed for long term patient wearability. To this end, the
electrode arrays include a therapeutic or prophylactic material
which ameliorates, reduces or prevents irritation to the patient's
skin in contact with the electrode arrays. Therapeutic or
prophylactic materials may include, for example, wound healing
agents, moisturizers, emollients, protective agents or
antibacterial agents. Each electrode array comprises electrically
conductive areas (electrodes) and electrically non-conductive areas
(passive areas). The electrodes are capable of sensing the
electrical activity of the heart, delivering electrical impulses
(cardio and defibrillation) to the heart, as well as tactile
stimulation and pacing signals.
[0034] The electrode arrays preferably include an adhesive portion
for adhering the array directly to the skin. However, external
means for retaining the electrode arrays in electrical proximity to
the skin may be used, such as a vest or a band. Long term
wearability of the electrode arrays may be enhanced by selecting
materials for use in the electrode array which minimize irritation
to the skin in contact with the array. Such materials may include,
for example, adhesives and backing materials having a high moisture
vapor transmission rate and conductive materials for use in the
electrodes having low salt (ionic) concentrations or comprised of
silicone or other adhesive materials that are conductive by means
of additives.
[0035] In another embodiment, long term wear can be enhanced and
skin irritation reduced by including in the system means for
monitoring, and adjusting as necessary, the environment at the
interface between the electrode array and the skin. Such means may
include, for example, means for monitoring and adjusting the {PH at
the skin-electrode interface in order to maintain a neutral
non-irritating interface; and means for controlling the ion flow at
the interface between the electrodes and the skin. In the latter
embodiment, ion flow would be reduced to a minimum except for the
short time during which a defibrillating shock is being delivered,
at which time the ion flow would temporarily increase to provide a
conductive path for the defibrillation impulse.
[0036] This brief summary has been provided so that the nature of
the invention may be understood quickly. A more complete
understanding of the invention can be obtained by reference to the
following detailed description of the preferred embodiments thereof
in connection with the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] FIG. 1 shows a defibrillation system according to the
present invention in a configuration for performing diagnostics and
data uploading.
[0038] FIG. 2 shows the defibrillation system according to the
present invention during use in connection with monitoring and
treating a patient.
[0039] FIG. 3 shows an electrode harness used with the
defibrillation system of FIGS. 1 and 2.
[0040] FIG. 4 shows a view of a sensing electrode and applicator
used in the electrode harness of FIG. 3.
[0041] FIG. 5 shows an application tray used to apply sensing
electrodes to a patient's body.
[0042] FIG. 6 shows defibrillation energy having a bi-phasic
waveform which is generated by the defibrillation system of the
present invention.
[0043] FIG. 7A shows a front view of a wearable defibrillator used
in the system shown in FIGS. 1 and 2.
[0044] FIG. 7B is an exploded view showing the mechanical
construction of the wearable defibrillator of the present
invention.
[0045] FIG. 8 shows a functional block diagram of the defibrillator
shown in FIG. 7A.
[0046] FIG. 9 shows a "221" capacitor configuration.
[0047] FIG. 10 shows a "2111" capacitor configuration.
[0048] FIG. 11 shows a "11111" capacitor configuration.
[0049] FIG. 12 is a flow diagram depicting general operation of the
wearable defibrillator of FIG. 7A.
[0050] FIG. 13 is a block diagram of electrical circuitry used in
the preferred embodiment of the present invention to implement the
functions shown in FIG. 8.
[0051] FIG. 14 shows capacitor switching circuitry used in the
preferred embodiment of the present invention.
[0052] FIG. 15 is a block diagram of a base station used in the
system of FIGS. 1 and 2.
[0053] FIG. 16 is a block diagram showing a preferred algorithm
used by the present invention to perform ECG analysis on received
patient information.
[0054] FIG. 17 is an exploded view of the primary power supply used
in the defibrillator of the present invention.
[0055] FIG. 18 shows a view of an alternative electrode and
applicator configuration that may be used in the present invention
that uses selectively applied adhesives in the applicators.
[0056] FIG. 19 is a view of an alternative electrode configuration
that may be used in the present invention.
[0057] FIGS. 20A and 20B are views of an alternative electrode
configuration that may be used in the present invention.
[0058] FIGS. 21A and 21B are views of an alternative electrode
configuration that may be used in the present invention.
[0059] FIG. 22 shows a view of an alternative electrode
configuration that may be used in the present invention.
[0060] FIG. 23 shows a view of an alternative electrode
configuration that may be used in the present invention.
[0061] FIG. 24 shows an embodiment of an electrode in which an
adhesive surface is covered with a pull-tab covering to allow the
patient to place the electrode on the patient's skin and then to
pull the tab to expose the adhesive surface.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0062] The present invention is directed to a defibrillation system
for use in treating patients who have suffered from cardiac
arrhythmias. A representative embodiment of the invention is shown
in FIGS. 1 and 2. As shown in these figures, defibrillation system
1 is comprised of base station 2, electrode harness 4, personal
computer 6, patient simulator 7, central repository 9, and wearable
defibrillator 10. A brief overview of the operation of each of
these components is provided below, followed by detailed
descriptions thereof.
[0063] Defibrillator 10 is capable of interfacing either to base
station 2, as shown in FIG. 1, or to electrode harness 4, as shown
in FIG. 2. To this end, both electrode harness 4 and base station 2
include physical connector identifiers at their respective
interfaces to defibrillator 10. By reading these connector
identifiers, defibrillator 10 is able to determine both the type of
interfaced device (i.e., a base station or electrode harness) and
the identity of a particular interfaced device (i.e., one electrode
harness as opposed to another), and then to react accordingly
[0064] Electrode harness 4 includes one or more sensing electrodes
31 which interface to patient 12, and which are used both to
monitor the patient and to transmit defibrillation energy to the
patient. In this regard, although defibrillator 10 may be utilized
with non-segmented electrodes having a low surface area or with
traditional defibrillation electrodes, sensing electrodes 31
comprise segmented electrodes since these require the most
description. Defibrillation energy, which can comprise an electric
signal having a bi-phasic waveform, a mono-phasic waveform, or a
truncated exponential waveform, is generated by defibrillator 10 in
the event that predetermined conditions have been detected in the
patient. These predetermined conditions include whether the patient
has suffered a cardiac arrhythmia, whether the patient is
conscious, as well as other conditions, such as patient impedance,
that are monitored by sensing electrodes 31.
[0065] Defibrillator 10 is also capable of providing pacing
impulses and tactile stimulation signals to the patient via
electrode harness 4. The tactile stimulation signals alert the
patient to abnormal cardiac activity in the patient, whereas the
pacing impulses stimulate contractions of the patient's heart.
While electrode harness 4 is being worn by the patient, data may be
transmitted directly from defibrillator 10 to personal computer 201
via non-contact interface 16.
[0066] When defibrillator 10 is interfaced to base station 2, as
shown in FIG. 1, base station 2 is able to perform diagnostics on
the defibrillator, to reprogram the defibrillator, and to retrieve
data stored in the defibrillator. Such data can include an
operational history of the defibrillator, information concerning
the patient's cardiac activity, and the like. All or some of this
retrieved data may be transmitted, via personal computer interface
14, to personal computer 6 for display and/or processing.
[0067] Data retrieved by base station 2 from defibrillator 10 may
be transmitted to central repository 9 via external data link 17.
Central repository 9 preferably stores this data, together with
patient and defibrillation information corresponding to a plurality
of other patients, all of whom use the same type of defibrillator.
A personal computer 19 is in communication with central repository
9. This personal computer may be used to analyze the patient and
defibrillation information received from defibrillator 10 in view
of corresponding information from the plurality of other patients,
and, if desired, to provide the results of this analysis back to
base station 2.
[0068] As shown in FIG. 1, defibrillator 10 also includes a link to
patient simulator 7. Patient simulator 7 comprises test equipment
which simulates bodily functions and characteristics of a patient,
including cardiac activity and thoracic impedance. During testing,
defibrillator 10 monitors patient simulator 7 in much the same way
that defibrillator 10 monitors a patient and, in a case that
predetermined conditions have been detected in patient simulator 7,
transmits defibrillation energy to patient simulator 7. To aid in
the testing process, patient simulator 7 also simulates patient
responses to the defibrillation energy provided by defibrillator 10
and provides response information back to defibrillator 10. This
response information may be transmitted to, and analyzed by, base
station 2, and then provided to any one or more of central
repository 9, computer 6, or defibrillator 10.
[0069] Electrode Harness
[0070] FIG. 3 shows a close-up view of electrode harness 4.
Electrode harness 4 is preferably disposable and, in preferred
embodiments of the invention, can be worn for approximately 2 to 7
days or longer for a cumulative period of 1 week to 12 months. To
this end, electrode harness may include a means for defibrillator
10 to determine how long electrode harness 4 has been connected
thereto. For example, in one embodiment of the invention, electrode
harness 4 includes an identification resistor (not shown) as its
physical connector identifier. Defibrillator 10 measures the
resistance across this resistor and then starts a countdown, after
which defibrillator 10 notifies the patient that it is time to
change the electrode harness. In this regard, each electrode
harness may include a different, unique resistance associated
therewith. Defibrillator 10 may measure this resistance by passing
a current therethrough and, in this manner, determine the identity
of an interfaced electrode harness.
[0071] As shown in FIG. 3, electrode harness 4 includes power
supply 20, connector 21, non-electrically conductive padding 22 and
24, electrical leads (or "lines") 26, 27, 29 and 30, and sensing
electrodes 31. Sensing electrodes 31 comprise the defibrillator's
interface to the patient. Specifically, sensing electrodes 31
attach to the patient so as to monitor the patient, transmit
tactile stimulation energy, and to transmit defibrillation energy
to the patient under appropriate circumstances. Each electrode may
comprise a single layer of conductive material. In preferred
embodiments of the invention, however, each electrode is
multi-layered as shown, for example, in the cross-sectional view of
electrode 31a in FIG. 4. In the example shown in FIG. 4, electrode
31a includes three layers, namely top cover assembly 32,
conductor/wire assembly 33, and skin interface 32
[0072] Skin interface 32 contacts directly with the patient's skin
and comprises a layer of material, such as a hydrogel, that is
capable of transmitting defibrillation energy to the patient
without causing substantial irritation or harm to the skin. For
larger patients, or hypoallergenic patients, conductive screens or
meshes can be used in addition to or in place of hydrogel. These
screens or meshes may be used in combination with a cream, such as
a hydrating cream or a skin healing cream. Such creams also may be
applied to the patient's skin before attaching the electrodes
thereto.
[0073] Skin interface 32 contacts to conductor/wire assembly 34,
which can be either substantially coextensive with, or smaller
than, skin interface 32. Conductor/wire assembly 34 includes
conductive layer 34a, wire connection 34b, wire 34c, and sealing
layer 34d. Conductive layer 34a preferably comprises a
silver/silver chloride polymer base ink silk-screened onto a layer
of Tyvek (used as an insulator and as a carrier) which is die-cut
and folded. A wire with a welded washer is then attached to
conductive layer 34a by means of a washer (tin plated nickel) and
eyelet (a hollow rivet that is crimped in order to hold the
assembly together). Insulating tape is then wrapped around this
connection in order to reduce corrosion.
[0074] As an alternative to the silver/silver chloride formulation,
conductor 34a may comprise conductive metal such as tin, silver,
gold, copper, salts or oxides of these conductive metals, carbon, a
substrate which has been coated with a conductive compound (e.g.,
polytetrafluoroethylene), an ink silkscreened on a carrier,
metallized cloth, solid metal or carbon grid, foil, plate, etc.
Conductor 34 preferably has a thickness which is sufficient to
transmit at least ten successive defibrillation energy signals
having peak amplitudes of 23 amperes for a duration of 10.75 msec
each.
[0075] Top cover assembly 33 includes foam insulating layer 33a and
wearable adhesive layer 37. Adhesive 37, which can comprise an
adhesive material fixed to a backing, such as tape or the like, is
disposed adjacent to conductor 34 and/or skin interface 32 and is
used to attach electrode 31a to the patient's skin. In preferred
embodiments of the invention, adhesive 37 may also be temperature
sensitive, meaning that adhesion thereof increases or decreases in
response to temperature variations. Adhesive 37 is preferably
non-conductive.
[0076] Adhesive 37 should also be adapted for long-term wear. To
this end, an adhesive having a high moisture vapor transmission
rate ("MVTR") of approximately 300 to 1500 g/m.sup.2/day is
suitable for use with the invention. By virtue of this feature of
the invention, the adhesive is made breathable, meaning that it
permits air to be transmitted therethrough to the patient's skin.
This increases the amount of time an electrode may be worn without
causing substantial harm to the patient's skin. Adhesive 37 should
also be sufficient to adhere to the patient's body in the face of
normal movements or muscle contractions and in the face of normal
water exposure such as might occur during bathing or sweating.
However, adhesive 37 should not be so strong as to cause
substantial discomfort during removal of an electrode. To this end,
adhesive 37 preferably has a peel strength of 500 g/cm or less.
[0077] Also shown in FIG. 4 are applicator 35 and release liner
assembly 36. Applicator 35 includes two layers--a bottom layer
having cut-outs 35a and a top layer having an adhesive 35b.
Cut-outs 35a limit the amount of adhesive that contacts the top
side of the electrode. Release liner assembly 36 includes cut-out
36a on upper layer 36b (closest to the hydrogel) which causes only
a portion of urethane bottom layer 36c to come into contact with
upper layer 36b. This configuration of release liner assembly 36,
particularly cut-out 36a, allows bottom layer 36c to be removed
first from an electrode, followed by upper-layer 36b, without
causing any separation of the electrode from the applicator
assembly. Moreover, cut-outs 35a on applicator 35b facilitate
removal of applicator 35b from top cover assembly 35 without
causing harm to the electrode.
[0078] An alternative electrode configuration to that shown in FIG.
4 is shown in FIG. 18. FIGS. 19 to 24 show additional alternative
electrode configurations. FIG. 19 shows a finger-patterned
electrode 200 comprising a conductive adhesive polymer layer 220, a
carbon sheet 240, and a medical adhesive carrier 260, covering and
extending beyond the edges of the polymer layer 220 and the carbon
sheet 240. In other embodiments, a metal sheet or a metal fabric
may replace carbon sheet 220.
[0079] FIG. 20A and FIG. 20B show a rectangular electrode 300
comprising metal foil sheet 320, pressure pad backing 340 and
medical adhesive carrier 360, covering and extending beyond the
edges of the metal foil sheet 320 and the pressure pad backing 340.
The front surface of metal foil sheet 320 comes in contact with
patient's skin 380 and pressure pad backing 340 contacts the back
surface of metal foil sheet 320 and keeps metal foil sheet 320 in
close contact with skin 380. In this regard, a pressure pad is a
unit which can be deformed by pressure applied in the direction
perpendicular to the skin. By maintaining a thickness that is less
than a free dimension, pressure in the pad is assured. Medical
adhesive carrier 360 contacts pressure pad backing 340. In another
embodiment, a metal fabric replaces metal foil sheet 320.
[0080] FIGS. 21A and 21B show rectangular electrode 400 comprising
metal foil sheet 420, pressure pad backing 440, stiffener 460, and
medical adhesive carrier 480. The front surface of metal foil 420
is in contact with skin 490; the front surface of pressure pad 440
is in contact with the back surface of metal foil 420; the front
surface of stiffener 460 is in contact with the back surface of
pressure pad 440; and medical adhesive carrier 480 is in contact
with stiffener 460 and covers and extends beyond the edges of all
other layers (420, 440, and 460). Stiffener 460 comprises a
material which will resist bending, and stiffener 460 is used to
transmit force into the electrode area. In a preferred embodiment,
stiffener 460 comprises a thin plastic material with an area that
is slightly larger than areas of metal foil sheet 420 and pressure
pad backing 440. In another embodiment, a metal fabric replaces
metal foil sheet 420.
[0081] FIG. 22 shows electrode 500 with alternating strips of
active areas 520 and space 540 for breathing. Each active area 520
comprises a metal foil sheet and a pressure pad backing. The strips
of active areas 520 are in contact with stiffener 560, and
stiffener 560 is in contact with medical adhesive carrier 580. In
another embodiment, a metal fabric replaces the metal foil in each
active area 520. In yet other embodiments, each active area
comprises a metal foil sheet or a metal fabric, a pressure pad
backing and a stiffener. The back surfaces of the active areas are
in contact with a medical adhesive carrier.
[0082] FIG. 23 show electrode 600 with multiple small square-shaped
active areas 620. As in the alternative strip configuration, active
areas 620 are spaced for breathing. Each active area 620 comprises
a metal foil and a pressure pad backing. The back surfaces of
active areas 620 are in contact with the front surface of stiffener
640, and medical adhesive carrier 660 is in contact with the back
surface of stiffener 640. In another embodiment, a metal fabric
replaces the metal foil sheet. In yet other embodiments, each
active area comprises a metal foil sheet or a metal fabric, a
pressure pad backing and a stiffener. Back surfaces of the active
areas are in contact with a medical adhesive carrier.
[0083] FIG. 24 shows an embodiment of the electrode in which the
adhesive surface is covered with a pull-tab covering to allow the
patient to place the electrode on the skin and then pull the tab to
expose the adhesive surface and maintain the electrode in
place.
[0084] A conductive portion of each sensing electrode, which in
this case are segmented electrodes, preferably has a surface area
that is roughly 8 to 10 cm.sup.2; although other dimensions may be
used. The present invention, however, takes advantage of "spreading
resistance" in the patient's bodily tissue so as to permit this
reduction in the surface area of the conductive portion each
electrode. Spreading resistance is a property of human tissue which
causes defibrillation energy (or any other electric signal for that
matter) applied to the patient's skin to spread outward over the
skin and downward and outward through the patient's tissue. In the
context of the present invention, once current from the
defibrillation energy is applied from an electrode to the patient's
skin, the current diffuses beyond the electrode and continues to
diffuse as the current moves into the underlying tissue. As a
result of this diffusion, the density of the current decreases with
increasing distance from the perimeter of the electrode. The
present invention compensates for this by placing sensing
electrodes 31 in a geometric pattern such that the interaction
between diffusing current from each sensing electrode results in an
accumulation of spreading current in areas between sensing
electrodes 31. The result is that an effective area is created in
which current densities in the path between groups of sensing
electrodes (e.g., sensing electrodes 31a, 31b and 31c shown in FIG.
3) are similar to that of a large electrode having a perimeter
equal to an outer perimeter of all of the sensing electrodes in the
group. A similar effect may be achieved through random placement of
the electrodes on the patient.
[0085] Thus, by spatially arranging the sensing electrodes to take
advantage of human tissue's spreading resistance, the present
invention is able to create a "virtual" conductive surface using
relatively small electrodes. The virtual conductive surface can be
significantly larger than a combined conducive area of the
individual sensing electrodes. This also contributes to a lower
impedance for a combined surface area of the sensing electrodes
than would be the case for a continuous electrode having a similar
surface area.
[0086] Each of sensing electrodes 31 may be shaped so that the
conductive portion thereof has a perimeter which is greater than a
circumference corresponding to a radius of the electrode. That is,
since charge tends to migrate to the perimeter of an electrode, the
present invention attempts to maximize the perimeter of each
electrode, particularly conductive surfaces thereof, thereby
increasing the amplitude of the defibrillation energy that the
electrode can handle without causing substantial burns to the
patient. Examples of electrodes with such a perimeter include
star-shaped electrodes, square electrodes, swirled-shaped
electrodes, etc. It is, however, noted that conventional circular
electrodes may be used in conjunction with the present invention as
well.
[0087] To increase operational efficiency of sensing electrodes 31,
sensing electrodes 31 should be placed within a "thoracic window"
on the patient's body. A thoracic window is defined as an area of
the patient's body which is suitable for placing electrodes so as
to optimize delivery of defibrillation energy to the patient's
heart, and is described in an article by Geddes et al. the American
Heart Journal, volume 94, page 67 (1977), the contents of which are
hereby incorporated by reference into the subject application as if
set forth herein in full. In this regard, there are two currently
defined thoracic windows on a patient. These comprise the
anterior-posterior thoracic window and the apex-sternum thoracic
window. In the apex-sternum thoracic window, electrodes are
typically placed underneath the patient's left rib cage and over
the patients right shoulder area. In the anterior-posterior
thoracic window, electrodes are typically placed on a patient's
lower left back and left front. Preferably, the sensing electrodes
are placeable over the thoracic window either randomly or in a
geometric pattern which is sufficient to cover a large enough area
of the patient's myocardium to cause adequate defibrillation upon
application of defibrillation energy.
[0088] Electrodes 31 can be attached or placed in contact with the
skin by various methods. Proper defibrillation requires that the
electrodes be in close contact with the patient's skin, in addition
to being placed in an appropriate location within the patient's
thoracic window area. Preferably, the electrode are attached to the
patient's skin using an adhesive thereon, as described in more
detail below. However, other attachment means are possible. For
example, a thoracic wrap made out of cotton or spandex can be used
to assure proper placement of the electrodes and good contact
between the electrodes an the skin.
[0089] In order to ensure proper current accumulation in areas
between the sensing electrodes, each sensing electrode in a group
(e.g., the group of electrodes 31a, 31b and 31c) should be placed
within a predetermined distance of other sensing electrodes in the
group. In preferred embodiments of the invention, each sensing
electrode in each group of electrodes is separated from other
sensing electrodes in that same group by between 0.5 and 3 times an
effective diameter of each electrode, where the effective diameter
corresponds to the farthest distance between two points on the
electrode. To ensure proper separation among the sensing
electrodes, electrode harness 4 includes non-electrically
conductive pads 22 and 24 (i.e., the passive areas), on which
groups of sensing electrodes can be mounted in predetermined
geometric configurations. For example, as shown in FIG. 3, sensing
electrodes 31a, 31b and 31c (i.e., the active areas) are mounted on
pad 22 in a triangular configuration, while sensing electrodes 31d,
31e, 31f and 31g are mounted on pad 24 in a rectangular
configuration. Although FIG. 3 shows only two geometric
arrangements for sensing electrodes 31, the invention is not
limited to these. Rather, any geometric arrangement may be
utilized, including, but not limited to, a checkerboard pattern,
swirl patterns, interlocking patterns, star patterns, crescent
patterns, E-shaped patterns, F-shaped patterns, L-shaped patterns,
X-shaped patterns, H-shaped patterns, O-shaped patterns, C-shaped
patterns, etc. Of course, the electrodes may be arranged in a
random manner as well.
[0090] Preferably, pads 22 and 24 are flexible so as to facilitate
placement of sensing electrodes 31 on contours of the patient's
body. It is noted, however, that pads 22 and 24 need not be
flexible. Rather, an adhesive tape can be used in place of pads 22
and 24 or, alternatively, in addition to pads 22 and 24. As still
another alternative, pads 22 and 24 can be used selectively in
electrode harness 4, meaning that pads can be used to mount some of
sensing electrodes 31 and not others. In fact, this is the case in
the representative embodiment of the invention depicted in FIG. 3.
That is, in the embodiment shown in FIG. 3, segmented electrodes is
not mounted on a pad, but rather "floats", meaning that it can be
mounted anywhere on a patient's body, constrained, of course, by
the length of its electrical lead 30. As described below, electrode
31h does not provide the defibrillation energy to the patient, but
rather is used only to monitor the patient's ECG. However, to
provide greater flexibility in electrode placement, in alternative
embodiments of the invention, all electrodes may float in the same
manner as sensing electrode 31h. In the case that all or some
electrodes float, the invention may include an applicator tray,
such as tray 39 shown in FIG. 5, having cups 40 which arrange the
electrodes in geometric pattens so as to ensure accurate placement
within the patient's thoracic window. That is, the applicator tray
ensures that the electrodes will be spatially arranged in the
manner described above so as to take advantage of human tissue's
spreading effect.
[0091] As noted above, electrodes 31 may include a hydrogel or
other conductive material on a surface thereof which comes into
contact with the patient's skin, i.e., on the skin interface of the
electrode. The hydrogel is electrically conductive, thereby
permitting transmission of the defibrillation energy to the
patient, but has a relatively low ion concentration that is low
enough so as to not to cause substantial skin irritation. In
preferred embodiments, the conductivity of the hydrogel is variable
based, e.g., on temperature, etc. In addition, the hydrogel
preferably has a relatively high MVTR, thereby making the hydrogel
breathable. As was the case above with respect to adhesive 37, this
reduces skin irritation caused by wearing the electrodes, and thus
increases the amount of time that the electrodes can be worn.
[0092] Hydrogels or other conductive materials used with
conventional ECG electrodes may be used in the present invention,
since the deleterious effects of such materials will be countered
by the present invention for reasons described both above and
below. In addition, conductive materials which meet the above
qualifications include electrolytes, such as sodium chloride
(NaCl), potassium chloride (KCl), or lithium chloride (LiCl).
Currently preferred hydrogel materials include hydrophilic
polymers, such as karaya gum, gum acacia, locust bean gum,
polysaccharide gum, modified polysaccharide, or polyacrylamide. A
hydrating agent, such as water or polyhydric alcohol (e.g.,
glycerine, propylene glycol, triethylene glycol, glycerol, etc.)
may also be included in the conductive material. In these cases,
water is typically present at a concentration from about 1% to 60%
by weight, whereas polyhydric alcohol is typically present at a
concentration from about 10% to 50% by weight.
[0093] As noted above, the electrode interface to the skin may
include, instead of or in addition to a hydrogel, a mesh, screen,
or other porous material. These elements are conductive and, due to
their porous nature, allow air to pass therethrough to the
patient's skin. As was the case with the hydrogel described above,
this feature of the invention provides for prolonged wearability of
the electrodes.
[0094] The hydrogel on each sensing electrode may also include a
therapeutic or prophylactic agent which reduces skin irritation
caused by the electrode, and/or which promotes healing of wounds or
skin irritation that may be caused by the sensing electrodes. Such
an agent may be applied directly to each electrode, or capsules
which release the agent in response to the defibrillation energy
may be applied to the electrode. A therapeutic or prophylactic
agent may also be included on each of pads 22 and 24 in order to
promote skin health. Agents which render the patient's skin porous,
such as keratolytic agents (e.g., salicylic acid) or rubefacient
(e.g., methyl salicylate) may be included on each electrode or pad
so as to facilitate transmission of the therapeutic or prophylactic
agent into the skin and/or to permit use of low water content
hydrogels.
[0095] Examples of therapeutic or prophylactic agents that may be
used with the present invention include moisturizers, emollients,
bactericides, mold inhibitors, stabilizers or buffers to maintain a
neutral PH and to reduce corrosion and skin sensitivity, gelation
inhibitors (e.g., Mg(OAc).sub.2), healing agents, hormonal agents
(e.g., hydrocortisone (steroids)), protective agents, etc. Examples
of acceptable bactericides and mold inhibitors include
antibactierals, antiseptics, antifungals, boric acid, bacitracin,
acriflavine, formaldehyde, gentian violet, mercuric sulfide,
mercurochrome, neomycin, and iodine. Examples of acceptable
stabilizers include oligo or polybasic organic acids and their
salts (including chelating agents), polyethers, tartaric acid,
citric acid, and n-alkyl sulfonate, where n is from 8 to 16 carbon
atoms. Examples of acceptable healing agents include allantoin,
peruvian balsam, vitamin A, and vitamin B. Examples of acceptable
protective agents include benzoin, charcoal, talc, zinc oxide, and
aloe vera. These therapeutic agents may be used both prior to use
or after use to promote healing.
[0096] The amount of therapeutic or prophylactic material used
corresponds to an amount effective to reduce irritation, or to
promote recovery of irritated skin. The therapeutic or prophylactic
agent may be in any form useful to achieve the intended purpose,
including liquid solutions, creams, gels, solids, granules, powders
or any other form, including microcapsules. As noted above, the
therapeutic or prophylactic agent may be included as part of the
electrode, e.g., incorporated in the conductive areas of the
electrode, or incorporated in a passive area of the electrode
array. Alternatively, the electrode array may comprise three areas:
electrode areas, passive areas and areas containing the therapeutic
or prophylactic material. In addition, the therapeutic or
prophylactic material may be applied to the skin prior to attaching
the electrodes (pre-treatment), or after the electrodes have been
removed (post-treatment). In another embodiment, skin irritation
may be reduced by including in the electrode array means for
monitoring, controlling and/or correcting the skin environment in
contact with the electrode array. For example, it is possible to
monitor the electrode-to-skin PH, and adjust the PH accordingly.
Along these lines, the electrodes may comprise a multi-layered
matrix for controlling ion flow between the skin and the
electrode.
[0097] In alternative embodiments of the invention, rather than
using the sensing electrode configuration described above, i.e.,
segmented electrodes, non-segmented electrodes having conductive
portions of less than 60 cm.sup.2 and, in some cases, even to less
than 30 cm.sup.2 may be utilized. In this regard, traditionally, it
was necessary for conductive portions of defibrillation electrodes
to have a surface area of 60 cm.sup.2 to 80 cm.sup.2 in order to
deliver a sufficient defibrillation energy to the patient. The
present invention, however, takes advantage of the "spreading
resistance" effect described above so as to permit reduction in the
surface area of each electrode. Of course, the features described
herein with respect to sensing electrodes 31 may also be used in
conjunction with the non-segmented electrodes described herein.
These features include, but are not limited to, using hydrogels
having low ion concentrations, therapeutic and prophylactic agents,
and/or high MVTRs, effecting electrode movement relative to the
patient so as to reduce the deleterious effects of
electrode-to-skin contact, etc., utilizing an adhesive designed for
long-term wear, etc. As well, the following monitoring and
energy-transmitting functions described with respect to segmented
electrodes may also be used in conjunction with the non-segmented
electrodes described herein.
[0098] In still other embodiments of the invention, traditional
non-segmented defibrillation electrodes, i.e., electrodes having a
surface area of 60 cm.sup.2 to 80 cm.sup.2, may be used in
conjunction with all aspects of the invention described herein,
particularly those aspects of the invention that provide for long
term (i.e., greater than two days) wearability of the electrodes.
In this regard, these aspects include, but are not limited to,
using the electrodes in conjunction with hydrogels having low ion
concentrations, therapeutic and prophylactic agents, and/or high
MVTRs, effecting electrode movement relative to the patient so as
to reduce the deleterious effects of electrode-to-skin contact,
etc., utilizing an adhesive designed for long-term wear, etc. As
well, the following monitoring and energy-transmitting functions
described with respect to sensing electrodes 31 may also be used in
conjunction with the traditional non-segmented electrodes described
herein.
[0099] It is noted that defibrillator 10 may also be used with any
type of commercially-available subcutaneous electrode as well. It
is still further noted that the invention may include combinations
of two or more of the foregoing types of electrodes.
[0100] Referring back to FIG. 3, in electrode harness 4, each group
of electrodes and/or single electrode has at least one electrical
lead mechanically connected between its lead interface and power
supply 20. The leads can be standard cables comprising electrically
conductive wires sheathed in a flexible, protective material, e.g.,
a flexible plastic material. The wires used in the leads preferably
are able to carry repeated defibrillation impulses of at least 20 A
for a 20 millisecond duration, and preferably have adequate
insulation qualities satisfying a high potential test for about
1750 V. In addition, the cables preferably are flexible, durable,
soft and comfortable while having sturdy insulation.
[0101] An exploded view of power supply 20 is shown in FIG. 17. As
shown in FIG. 17, power supply 20 includes base 180, top 181 and,
sandwiched therebetween, batteries 184. Power supply 20 is also
comprised of connector 21, which includes the physical connector
identifier for electrode harness 4, and which interfaces power
supply 20 and electrical leads 26, 27, 29 and 30 to defibrillator
10. To this end, connector 21 includes socket 186 which receives
the electrical leads via holes 185. Socket 186 fits within top 181
such that pin 188 on top 181 contacts with hole 190 on socket 186.
Socket 186 is shielded so as to protect signals being transmitted
therethrough from batteries 184. This shielding is tied to the
"floating" ground in the battery and also to shields from the leads
to the electrodes.
[0102] In preferred embodiments of the invention, each electrical
lead is non-removably connected to connector 21 on power supply 20,
meaning that each lead is hard-wired to connector 21 or is
otherwise connected to connector 21 in a way in which removal of
the electrical leads from connector 21 will damage either one or
both of these components. It is noted, however, that alternative
embodiments of the invention are possible, in which each lead is
removably connected to connector 21.
[0103] Power supply 20 comprises the primary power cell for
wearable defibrillator 10. To this end, batteries 184 comprise
non-rechargeable lithium batteries (e.g., DL123A, size 2/3 A) which
are capable of providing 2 to 7 days of normal operation of
defibrillator 10, including delivering at least six defibrillation
energy (i.e., shocks) having peak currents of 23 A to the patient.
In this regard, the working voltage of power supply 20 is
preferably 3.3 to 6.6 V, with the maximum output being 6.6 V.
[0104] In preferred embodiments, power supply 20 is made
water-resistant by sealing power supply 20 within a silicone
membrane (not shown) or the like. In this regard, power supply 20
may be made water-resistant by a number of other means as well. For
example, it is possible to use a variety of other insulating
materials in place of silicone. By sealing power supply 20 in this
manner, it is possible to reduce the risk of unintended electric
shock during activities, such as showering or the like.
[0105] Each electrical lead on electrode harness 4 has a length
that is sufficient for each corresponding electrode or group of
electrodes to be placed on the patient at a predetermined distance
away from others of the electrodes or groups of electrodes. As
noted above, by spatially arranging defibrillator (as opposed to
solely ECG) electrodes in this manner, the invention ensures proper
accumulation of current in areas between the sensing electrodes.
The present invention provides an additional advantage in this
regard in that groups of electrodes arranged in geometric patterns
on the patient are movable relative to the patient in a manner
which ensures that the geometric patterns are substantially
retained, but are at different orientations relative to the
patient. For example, it is possible to rotate pad 22 containing
sensing electrodes 31a, 31b and 31c on a patient such that pad 22
is still within the patient's thoracic window (e.g., either the
apex-sternum thoracic window, the anterior-posterior thoracic
window, or some combination thereof), but such that sensing
electrodes 31a, 31b and 31c do not contact the patient's skin at
the same location. Random rotation or movement may also be used to
accomplish the same result. For example, in a case that electrodes
31 all float, random motion may be the best way in which to achieve
the desired result. Moreover, in accordance with the invention, and
particularly with non-segmented electrodes, it is possible merely
to shift each electrode from a first position to a second position,
such that portions of the first and second positions overlap.
[0106] By providing for the foregoing rotation and/or movement,
together with the therapeutic and prophylactic agents described
above, the present invention reduces skin damage which may occur
due to prolonged use of wearable defibrillator 10. To achieve
optimum reduction in skin damage, each sensing electrodes 31, group
of sensing electrodes, or individual non-sensing electrodes should
be rotated in the above manner roughly once every 12 hours to 7
days.
[0107] In operation, sensing electrodes 31 are capable of
transmitting electrical signals from defibrillator 10 to a patient.
These electrical signals include, but are not necessarily limited
to, defibrillation energy, tactile stimulation signals, pacing
signals, and AC and DC signals used to measure a patient's skin and
thoracic impedance. The same information used to measure the
patient's thoracic impedance may also be used to determine the
patient's respiration and pulse rates. The defibrillation energy
preferably has a bi-phasic waveform with two phases. These phases
may have substantially equal durations or, alternatively, may have
different durations, e.g., the first phase may be roughly 6 msec
and the second phase may be roughly 4 msec. An example of a
bi-phasic waveform having substantially equal durations is shown in
FIG. 6 (described below).
[0108] As noted above, the waveform of the defibrillation energy
may also be mono-phasic, i.e., the waveform may comprise just the
first one of the two phases shown in FIG. 6, or may comprise a
truncated exponential waveform. Monophasic waveforms typically
require greater current, generally on the order of 15% to 20%
greater, in order to achieve substantially the same effect as
bi-phasic waveforms. Regarding the pacing impulses, these
preferably comprise waveforms having a low peak current of roughly
150 mA.
[0109] Sensing electrodes 31 are also capable of transmitting
patient information from the patient to defibrillator 10. This
patient information includes, but is not limited to, information
relating to the patient's skin and thoracic impedance, artifact
noise in the patient's body (caused, e.g., by cardiopulmonary
resuscitation, agonal breathing, seizures, patient handling, and
ambulatory or vehicular motion), sensory stimulation signals from
the patient, and the patient's ECG, including any cardiovascular
signals evidencing abnormal heart activity.
[0110] In this regard, electrode harness 4 preferably includes two
independent differential channels, namely "ECG 1" and "ECG 2" shown
in FIG. 3, for measuring the patient's ECG. In this regard, groups
of electrodes 31a, 31b and 31c and 31d, 31e, 31f and 31g comprising
ECG 1 both provide the defibrillation energy to the patient and
monitor the patient's ECG, whereas electrode 31h comprising ECG 2
is used solely for monitoring the patient's ECG. ECG 1 serves as
the primary monitoring channel for ECG analysis, whereas ECG 2
serves as a backup for use in a case that ECG 1 is not operating or
is not operating properly (e.g., if ECG 1 is relatively noisy).
Alternatively, ECG 2 can be used as a means of verifying the
validity of an ECG obtained via ECG 1. That is, by comparing ECGs
obtained from ECG 1 an ECG 2, it is possible to confirm the
validity of the patient's ECG. It is also possible to confirm
whether the electrodes are properly attached to the patient based
on this comparison. As still another alternative, it is possible to
"average" ECGs from ECG 1 and ECG 2, in order to obtain an averaged
ECG for the patient, or to increase ECG resolution by using inputs
from both ECG 1 and ECG 2. The use to which defibrillator 10 puts
the ECG signal, as well as the other signals obtained via an
electrode harness 4, is provided in detail below.
[0111] For example, defibrillator 10 provides several ways to
measure the patient's thoracic impedance based on information
received from sensing electrodes 31. Specifically, the patient's
impedance is determined directly by applying an AC or DC signal
through an electrode, sampling data obtained from the electrode in
response to the AC or DC signal, and analyzing the sampled data.
More specifically, in preferred embodiments of the invention, this
method of measuring the patient's thoracic impedance entails
sampling such data from an electrode within 5 seconds of
defibrillator power-on and then every 10 seconds for a 160 msec
period at a sample rate of 4 msec or to continuously sample the
impedance signal. Filtering is then performed on the sampled data
so as to reduce the bandwidth of the sampled data to less than 10
Hz. The sampled data is then analyzed so as to provide a noise
magnitude estimate for the signal and a frequency content of the
signal. Subsequent processing is then performed to obtain a
measurement of the patient's thoracic impedance by averaging all of
the data samples in each 160 msec period. This averaging and
filtering is performed in order to reduce the effects of artifact
noise associated with CPR, muscle tremors, and agonal breathing. Of
course, this processing occurs in defibrillator 10, and not in
electrode harness 4.
[0112] In addition to the foregoing method, the patient's thoracic
impedance is also calculated by defibrillator 10 each time the
defibrillation energy is transmitted to the patient. Specifically,
the patient's thoracic impedance may be determined before, during
and after transmission of defibrillation energy, based on patient
information received from the electrodes in response to the
defibrillation energy.
[0113] Wearable Defibrillator
[0114] A close-up view of defibrillator 10 is shown in FIG. 7A. As
shown in FIG. 7A, defibrillator 10 includes housing 40, light
emitting diode (hereinafter "LED") 41, visual indicator 42,
auditory indicator 44, annunciator 46, user interface 47,
communications link 49, and connector 50. FIG. 7B is an exploded
view showing the mechanical construction of the features shown in
FIG. 7A. A description of these features of the invention is
provided below.
[0115] Housing 40 is preferably small enough to make the
defibrillator portable, and thus wearable, yet large enough to
house the circuitry included within defibrillator 10. In this
regard, housing 40 can comprise a belt, or the like, which a
patient can wear around his or her waist, chest, etc. However, in
preferred embodiments of the invention, housing 40 comprises a
rectangular casing that is roughly 6 inches in length, by 4 inches
in width, by 2 inches in depth, or preferably 5.2 inches by 3.2
inches by 1.5 inches. As shown in FIG. 7B, housing 40 is comprised
of base 40a and top 40b. The preferred weight of defibrillator 10
is approximately 1.5 pounds or preferably 1.0 pound or lighter. In
this regard, the invention is able to achieve its small size by
using high-energy capacitors (e.g., 500 .mu.F, 400 .mu.F, etc.) to
store and deliver defibrillation energy, as described in more
detail below.
[0116] Connector 50 and communications link 49 comprise external
interfaces on defibrillator 10. Connector 50 is disposed on housing
40 so as to permit connection of defibrillator 10 to mating
connector 21 on power supply 20 (see FIG. 2), and to permit
connection of defibrillator 10 to corresponding mating connector 51
on base station 2 (see FIG. 1). To this end, connector 50
preferably includes two high-speed data pins (not shown), which
permits base station 2 to interface to defibrillator 10 at a same
point that electrode harness 4 interfaces to defibrillator 10. By
virtue of this arrangement, information can be transmitted between
defibrillator 10 and either base station 2 or a patient.
Communications link 49 comprises a non-contact interface to
personal computer 201 (see FIG. 2), over which information may be
transmitted between defibrillator 10 and personal computer 201 (see
FIG. 2) while defibrillator 10 is being worn by the patient or, if
desired, at other times as well. Examples of such a non-contact
interface include an infrared (hereinafter "IR") link or a radio
frequency (hereinafter "RF") link.
[0117] Visual indicator 42 comprises a liquid crystal display
(hereinafter "LCD") or the like (in preferred embodiments, a
Standish 162SLC 2.times.16 dot matrix display), having two lines
for displaying information, including text and errors, to a patient
or to a clinician operating defibrillator 10. This information can
include, but is not limited to, information concerning the
patient's heart activity, such as the patient's ECG or the like;
messages upon detection of abnormal activity in the patient's
heart; statements indicating that the patient has been wearing
electrode harness 4 for greater than a recommended period of time;
instructions for the use of defibrillator 10; prompts for using
defibrillator 10; errors that have occurred in defibrillator 10;
messages transmitted to defibrillator 10 from an external location
via base station 2, personal computer 6, or personal computer 201;
an indication that one or more of sensing electrodes 31 have become
detached from the patient; and an indication that defibrillator 10
cannot differentiate between artifact noise in a patient's body and
a cardiac arrhythmia. In preferred embodiments of the invention,
the information is displayed for about 15 seconds.
[0118] In addition to the LCD, one or more visual indicators, such
as light emitting diode (hereinafter "LED") 41, may be provided on
defibrillator 10 to indicate different operational states thereof.
For example, in preferred embodiments of the invention, LED 41
blinks when defibrillator 10 is operating normally, is off when
defibrillator 10 is without power (including when power supply 20
has failed), and is continuously illuminated during power-up error
detection diagnostics performed by defibrillator 10.
[0119] Auditory indicator 44 comprises a speaker (in preferred
embodiments, an MG Electronics MCS298 speaker) or the like, which
provides verbal messages corresponding to information displayed on
visual indicator 42. These messages may be output in a variety of
different languages on both visual indicator 42 and auditory
indicator 44. In preferred embodiments of the invention, auditory
indicator 41 echos visual display 42, and has a volume that is
adjustable at least up to 60 or 70 decibels. Auditory indicator 44
may also be configured to provide additional sounds, such as tones,
buzzing, beeping, etc. to indicate error conditions within
defibrillator 10. Examples of such error conditions include, but
are not limited to, a low or drained power supply, improper
attachment of sensing electrodes 31 to the patient, detachment of
sensing electrodes 31 from the patient, and inoperability of
defibrillator 10. In addition, another auditory indicator, such as
annunciator 46, may also be included on defibrillator 10.
Annunciator 46 is preferably separate from auditory indicator 42,
and produces a buzzing or other unique sound to indicate error
conditions within defibrillator 10, particularly a low or drained
power supply.
[0120] User interface 47 comprises a response button, whereby a
patient or clinician can provide an input to wearable defibrillator
10 simply by pressing the button. As shown in FIG. 7B, the response
button is comprised silicone 47a, button 47b, paddle 47c and foil
47d. The response button cancels any upcoming defibrillation
operation, meaning that, when pressed, the response button
terminates a current defibrillation and, in some embodiments of the
invention, disarms defibrillator 10. In preferred embodiments of
the invention, the response button is relatively large, making it
easily accessible to the patient, particularly through clothing and
the like. In addition, in preferred embodiments of the invention,
defibrillator 10 confirms when the response button has been pressed
by issuing both audio and visual messages. In operation, the
response button is pushed in response to, e.g., a "PLEASE RESPOND"
verbal message so as to confirm patient consciousness or lack
thereof. In preferred embodiments of the invention, defibrillator
10 also includes a cardiac event recording button which may or may
not be separate from the response button, and which is pushed when
the patient wants to record occurrence of a cardiac event. It is
noted that these two functions are combined during a potential
rescue situation; i.e., the patient will want to respond to the
defibrillator's response requests at the same time, possibly
recording the occurrence of a cardiac event. Combining these
functions into a single button helps train the patient to
habitually push the same button whenever there are requests from
the defibrillator or cardiac events.
[0121] FIG. 8 is a system functional block diagram of defibrillator
10. Briefly, the hardware and software functional blocks shown in
FIG. 8 monitor and analyze patient information (e.g., the patient's
ECG) received from electrode harness 4 in order to determine if a
cardiac rhythm is life threatening and requires defibrillation, and
also permits communication to base station 2, personal computer 6,
and personal computer 210. In addition, these blocks within
defibrillator 10 determine the patient's thoracic impedance based
on information received from the patient via electrode harness 4,
and adjust the defibrillation energy accordingly. Alternatively, a
predetermined thoracic impedance value may be stored in data
logging memory block 57. That predetermined thoracic impedance
value may then be retrieved and used to adjust the defibrillation
signal.
[0122] As shown in FIG. 8, defibrillator 10 comprises auditory
indicator 44, visual indicator 42, LED 41, user interface 47, and
annunciator 46. Descriptions of these features of the invention
were provided above and, therefore, will not be repeated here. It
is worth noting, however, that annunciator 46 receives power from
backup battery 54, which is rechargeable, and which is independent
of the primary source of power (i.e., power supply 20) for
defibrillator 10. Backup battery 54 provides power to annunciator
46 in the event that power supply 20 fails, thereby giving
annunciator 46 the ability to warn the patient in such an
event.
[0123] Defibrillator 10 also includes patient measurements block
56, data logging memory block 57, accessory communications block
59, real time clock (hereinafter "RTC") 60, RTC/RAM backup battery
61, which may or may not be separate from backup battery 54, and
signal generator 62. In the representative embodiment of the
invention described herein, signal generator 62 comprises
processing block 64, defibrillation control block 66,
discharge/protection switches 67, capacitors 69, charger 70 and
charge control block 71. In this regard, although the present
invention includes the forgoing blocks in signal generator 62, any
combination of hardware and/or software which effects the same
function as these features can be employed in the practice of the
present invention.
[0124] RTC 66 maintains the current date and time, receiving power
from rechargeable RTC/RAM backup battery 61 when defibrillator 10
is powered-off. In preferred embodiments of the invention, RTC 60
is a Dallas 1306 serial RTC, which is able to maintain the correct
time and date for up to 30 days without connection to power supply
20. RTC/RAM backup battery 61 also provides power to a memory
(e.g., a RAM (not shown)). Accessory communications block 59
performs any filtering and protocol conversion necessary to enable
transmission of data between defibrillator 10 and base station 2,
personal computer 6 and/or personal computer 210. Patient
measurements block 56 comprises analog signal conditioning hardware
which filters and digitizes ECG signals, thoracic impedance
measurements, and electrode-to-skin impedance measurements received
via electrode harness 4, and which transmits the resulting data to
processing block 64. Patient measurements block 56 also receives
information from an accelerometer, described below, relating to the
patient's motion, and provides this information to processing block
64.
[0125] Data logging memory block 57 stores both the operational
history of defibrillator 10 and information relating to the
patient. More specifically, data logging memory block 57 stores
abnormal heart activity of the patient; the patient's ECG before,
during and after application of defibrillation energy; an
indication that the patient has been trained for use with
defibrillator 10; analyzed ECG conditions; ECG markings, including
defibrillation synch, external pace pulse, high slew rate, and
saturation; patient thoracic and electrode-to-skin impedance
measurements over time; voice, tone, and buzzer prompts; displayed
messages; information concerning patient interaction with the
defibrillator 10 (e.g., if and when the patient has pressed the
response button); transmitted defibrillation waveform measurements,
including current and voltage versus time; execution time
measurements of defibrillator 10 for use in determining if
defibrillator 10 operated as expected; detected operational errors
of defibrillator 10 (including a type of error, persistence of the
error, whether defibrillator 10 was in the operational mode when
the error occurred, whether defibrillation had begun when the error
occurred, and whether a cardiac arrhythmia had been detected when
the error occurred); calibration data for defibrillator 10; the
serial number of defibrillator 10; a harness identification ID of
an electrode harness interfaced to defibrillator 10; cold and warm
start information for defibrillator 10; artifact noise in the
patient; data from an accelerometer relating to motion of the
patient; documentation regarding the defibrillator; instructions on
how to use the defibrillator; and patient parameters. These patient
parameters include, but are not limited to, the patient's ID number
which is a unique assigned identifier for each patient (range of 1
to 9,999; default=0); the patient's name; the language used for
voice and corresponding text messages; a minimum audio level to
which a patient responds; minimum tactile stimulation signal to
which a patient responds; maximum tactile stimulation signal for a
patient; pacing bradycardia rate--heartbeat rate below which
bradycardia will be declared and pace rescue initiated; pace
current level--current level needed to ensure pace rescue; a
ventricular tachycardia rate at which defibrillation energy is to
be delivered to the patient (range of 150 to 180 beats per minute
(hereinafter "bpm")); the patient's thoracic impedance range,
meaning, the impedance range during which defibrillation energy may
be transmitted to the patient (range of 15 to 200 ohms); a time and
a date at which the defibrillator was issued to the patient; a name
of a clinic at an external location (e.g., central repository 9, a
hospital, a doctor's office, etc.); a name of a clinician at the
external location; and an electrode-to-skin impedance range which
is used to determine whether the electrodes are not attached, or
are improperly attached, to the patient. Also stored with the
patient parameters is a checksum which is used to determine their
validity.
[0126] In summary, data logging memory block essentially stores any
information provided to, or transmitted from, defibrillator 10 over
a predetermined span of time, such as two days. This data is
preferably stored in a log format and includes time data specifying
a time at which each event occurred. In addition, embedded in the
data are validation and synchronization mechanisms for use in
detecting areas of corrupted or missing data.
[0127] In preferred embodiments of the invention, data logging
memory block 57 has a capacity (e.g., 24 megabytes or 48 megabytes)
which is sufficient to record the foregoing information over a 48
hour period of continuous use of defibrillator 10. In embodiments
of the invention where only a portion of the foregoing information
is stored in data logging memory block 57, there may be a
corresponding decrease in the size of data logging memory block 57
or a corresponding increase in the available period of use for the
device. On the other hand, to achieve a reduction in the required
amount of memory space without sacrificing data stored therein, it
is possible to compress the data, preferably at a 4-to-1
compression ratio, and then to store the compressed data in data
logging memory block 57. It is noted that the invention is not
limited to compressing the data at a 4-to-1 ratio, and that any
compression ratio may be used. Any of a number of well-known
compression algorithms, particularly those relating to biological
signal compression, may be employed to effect the necessary
compression. Compression techniques that result in lossless
compression, however, are preferred. In particularly preferred
embodiments of the invention, data logging memory block 57 is
removable, and can be transferred to the base station or to an
external location at which point data stored therein may be
downloaded.
[0128] Signal generator 62 generates, based on patient impedance
data provided from patient measurements block 56, defibrillation
energy which preferably has a bi-phasic waveform may have two
phases with substantially identical durations, different durations,
or a first phase with a longer duration than a second phase, and
having relatively low peak amplitudes over a patient impedance
range. A mono-phasic waveform or a truncated exponential waveform
having similar characteristics may also be used.
[0129] FIG. 6 shows a representative example of defibrillation
energy generated by signal generator 62. As shown in FIG. 6,
waveform 72 has two phases 74 and 76, each of which has
substantially the same durations 77 and 79 (i.e.,
t.sub.max=.about.5.4 seconds) and a peak amplitude of less than 23
amperes (i.e. I.sub.max=.about.20A). Specifically, the bi-phasic
waveform has a 5.37 msec (+/-5%) initial "positive" phase, followed
by a 100 to 300 .mu.sec zero-potential plateau (i.e.,
t.sub.switch=.about.180 .mu.sec), followed by another 5.37 msec
(+/-5%) "negative" phase. In preferred embodiments of the
invention, the amplitude at the end of the pulse is 60 to 80% of
its initial value. Of course, the example shown in FIG. 6 merely
representative, and waveforms having different values can also be
generated by the present invention. In fact, in preferred
embodiments of the invention, the duration of each phase of a
bi-phasic waveform may be between 4.5 and 6.4 msec.
[0130] The waveform corresponding to the defibrillation energy
preferably also has a substantially consistent tilt, as shown in
FIG. 6. In preferred embodiments, the tilt of the defibrillation
energy is between 53% and 79%. The present invention provides a way
in which to alter this tilt using capacitors 69. In this regard,
capacitors 69 store energy which is discharged to the patient via
discharge/protection switches 67 in the form of the foregoing
defibrillation energy. This energy is discharged as a waveform
having the foregoing characteristics. The tilt of the waveform
(i.e., the rate of the waveform's exponential decay) is determined
by the "RC" time constant .tau. of the circuit used to generate the
waveform. In this regard, that circuit's time constant .tau. may be
altered by switching capacitors 69, as described below, so as to
alter the overall, combined capacitance value of capacitors 69.
Thus, by switching capacitors 69 in this manner, it is possible to
vary the tilt of the waveform and the achieve a low-current
waveform.
[0131] To ensure safe operation, the energy for defibrillation
energy is discharged by capacitors 69 only in the case that a
life-threatening cardiac arrhythmia is detected in the patient (as
determined by comparing the patient's ECG to pre-stored patient
parameters), the patient is deemed to be unconscious (as
determined, e.g., by the patient's response, or lack thereof, to
messages provided by auditory indicator 44, visual indicator 42.
and annunciator 46), and the patient's thoracic impedance is within
a predetermined range. In preferred embodiments of the invention,
this range is between 15 ohms and 200 ohms. The process of
determining whether and when to transmit defibrillation energy to a
patient is described in more detail below. One (or more) of
capacitors 69 is also used to provide the above-noted tactile
stimulation signal to the patient. The tactile stimulation signal
may be used to alert the patient of the occurrence of a cardiac
event, and may vary based on the patient and based on which time it
is administered to the patient in response to a message from the
defibrillator. That same capacitor may also be used to deliver a
pacing signal to the patient's heart in order to stimulate normal
contractions thereof.
[0132] The invention preferably includes 5 capacitors having
capacitances of 500 .mu.F (350 V) each; although capacitors having
other capacitances may be used as well. The capacitors are
switchable into the "221" configuration shown in FIG. 9, in which
there are two sets of parallel capacitors in series with a single
capacitor; the "2111" configuration shown in FIG. 10, in which
there is one set of parallel capacitors in series with three single
capacitors; and the "11111" configuration shown in FIG. 11, in
which there are five single capacitors in series. In general, the
higher the impedance of the patient, the lower the peak current
that is required for the defibrillation energy (a lower tilt is
also required at higher impedances). Consequently, the higher the
impedance of the patient, the lower the capacitance that is
required to generate the defibrillation energy. For example, for a
patient whose impedance is relatively high (e.g., 120 ohms), the
11111 capacitor configuration may be used to generate
defibrillation energy having a maximum peak current of 15 A.
[0133] In this regard, the lower the impedance of the patient, the
higher the capacitance that is required to generate the
defibrillation energy. Thus, for patients whose impedance is
relatively low (e.g., 40 ohms), the 221 capacitor configuration may
be used to generate defibrillation energy having a maximum peak
current of 21 A.
[0134] Table 1, shown below, provides values for I.sub.max+,
I.sub.avrg+, I.sub.final, t.sub.max+, t.sub.switch, and t.sub.max-
(see FIG. 6) for defibrillation energy for patients having
impedances of 40, 60, 80 and 120 ohms. These values are merely
representative of a particular case, and other values, of course,
may be substituted therefor. In this regard, as noted above, the
duration of each phase is roughly between 4.5-6.5 msec, and the
peak current is roughly between 12 and 25 A.
1 TABLE 1 40 ohms 60 ohms 80 ohms 120 ohms I.sub.max + 21 A 20 A 20
A 15 A I.sub.avrg + 15 A 15 A 15 A 11 A I.sub.final - -7.0 A -6.0 A
-5.0 A -5.5 A t.sub.max + 5.4 ms 5.4 ms 5.4 ms 5.4 ms t.sub.switch
0.2 ms 0.2 ms 0.2 ms 0.2 ms t.sub.max - 5.4 ms 5.4 ms 5.4 ms 5.4
ms
[0135] In addition to using capacitors 69 to control the waveform
of the defibrillation energy in the foregoing manner, the invention
may also include a resistor, placed in series with the capacitors.
Due to the resistor's effect on the circuit's time constant, the
resistor has the effect of "smoothing", i.e., decreasing the tilt
of, the waveform of the defibrillation energy. In this regard,
generally speaking, an increase in the resistance of the resistor
decreases the tilt of the waveform. As an alternative to the
foregoing configuration, the invention may include a single
capacitor and one or more switchable resistors to achieve the
effect of varying the circuit's time constant and thereby varying
the waveform of the defibrillation energy.
[0136] As noted above, discharge/protection switches 67 control
delivery of the defibrillation energy from capacitors 69 to the
patient. Discharge/protection switches 67 are controlled by
defibrillation control block 66 which, in turn, is controlled by
processing block 64. Specifically, when defibrillator 10 is not in
use, or is not required to provide an output signal, processing
block 64 commands defibrillation control block 66 to open
discharge/protection switches 67, thereby providing protection from
unwanted electric signals. On the other hand, when processing block
64 determines that defibrillation energy is to be transmitted to
the patient, processing block 64 immediately commands
defibrillation block control block 66 to close discharge/protection
switches 67, thereby providing the energy to the patient. In this
regard, as noted above, one of capacitors 69 is also able to
transmit tactile stimulation and pacing signals to the patient. In
a case that a tactile stimulation or a pacing signal, as opposed to
the defibrillation energy, is to be transmitted, processing block
64 issues a command to defibrillation control block 66 which, in
response, may switch one of discharge protection switches 67 so as
to output a signal from only one of capacitors 69. As shown in FIG.
8, defibrillator control block 66 also monitors
discharge/protection switches 67 and provides the results thereof
to processing block 64.
[0137] Charger 70 controls charging of capacitors 69 from power
supply 20, the input of which is labeled 20a in FIG. 8.
Specifically, charger 70 comprises hardware which transfers energy
from power supply 20 to capacitors 69. Charger control block 71
controls charger 70 in response to commands received from
processing block 64 so that capacitors 69 charge to a level
commanded by processing block 64. In this regard, processing block
64 may issue commands to charge capacitors 69 to one of a plurality
of different levels depending on a determined type of arrhythmia,
e.g., ventricular fibrillation versus ventricular tachycardia.
Thus, if a ventricular fibrillation is detected, then a signal
having a higher amplitude is output, whereas if a ventricular
tachycardia is detected, then a "cardio" or lower amplitude
defibrillation signal is output. Processing block may also issue
commands to charge processing block 69 based on a type of signal to
be transmitted, e.g., defibrillation energy, a pacing impulse, or a
tactile stimulation signal.
[0138] Processing block 64 can comprise a microprocessor,
controller, or the like, as described below, which includes an
internal program memory (not shown in FIG. 8). This memory is used
to store software modules comprised of process steps that are
executable by processing block 64. Specifically, process steps in
these modules are executable to control operation of defibrillator
10 based on input received from a patient or, alternatively, from
base station 2 (see FIG. 1). These software modules comprise
input/output (hereinafter "I/O") module 80, including
communications submodule 81 therein, data recording module 82,
diagnostics module 84, defibrillation control module 86, ECG
analysis module 87, user interface protocols 89, and master control
module 90.
[0139] I/O module 80 preferably comprises a BIOS module which
controls the transfer of data between software modules running
within processing block 64 and hardware components within
defibrillator 10. I/O module 80 also controls communications
between processing block 64 and auditory indicator 44, visual
indicator 42, LED 41, and user interface 47. To this end, the
invention includes user interface protocols 89, between master
control module 90 and I/O module 80. User interface protocols 89
comprise command sequences for controlling transmission of various
prompts, such as tones, verbal messages, or the like, to the user
via auditory indicator 44, visual indicator 42, and LED 41 in
response to detected events, such as a cardiac arrhythmias or the
like. Similarly, user interface protocols 89 include command
sequences for controlling receipt of signals input by the user via
user interface 47 (i.e., the response button). Communications
submodule 81 controls communications between processing block 64
and an interfaced device, such as electrode harness 4 or base
station 2, via accessory communications block 59. Processing block
64 also executes a low-level, run time executive (hereinafter
"RTE") module (not shown), which supports communication between the
various software tasks running in processing block 64.
[0140] ECG analysis module 87 comprises process steps which monitor
the patient for a predetermined condition based on information
provided through electrodes 31. ECG analysis module analyzes the
patient's ECG and impedance data provided from sensing electrodes
31 (via patient measurements circuit 56), together with other
information provided from the patient, including artifact noise and
patient motion, in order to determine whether, when, and what types
of arrhythmias are present in the patient's ECG.
[0141] More specifically, ECG analysis module 87 performs any
necessary signal processing on the patient's ECG and thoracic
impedance data in order to remove any extraneous data such as may
be present due to noise in the patient's body, including artifact
noise or noise caused by patient motion. Assuming that ECG analysis
module 87 is able to remove extraneous noise from the patient's ECG
and impedance data, ECG analysis module 87 compares the patient's
ECG and thoracic impedance data to the patient parameters stored in
data logging memory block 57 (e.g., the patient's thoracic
impedance range and ventricular fibrillation and ventricular
tachycardia rates at which defibrillation, pacing or cardio
(described below) signals should be administered) in order to
determine whether an arrhythmia has occurred. In the case that ECG
analysis module 87 determines that an arrhythmia has occurred, ECG
analysis module 87 analyzes the patient's ECG and the patient
parameters in order to determine the type of arrhythmia, i.e.,
whether the arrhythmia comprises ventricular fibrillation,
ventricular tachycardia, asystole, bradycardia, or indioventricular
rhythms, and whether defibrillation energy should be transmitted to
the patient in response to the arrhythmia. Specifically, ECG
analysis module 87 determines if the patient's rhythm is normal,
meaning that the patient has a normal heartbeat, in which case no
intervention is required; bradycardia, meaning that the measured
heartbeat is less than 5 bpm; ventricular fibrillation which
comprises uncoordinated rapid contractions of the heart which
replace normal synchronous pumping action, specifically in the
heart's lower chambers; ventricular tachycardia which comprise a
threatening heart condition associated with a very rapid heart rate
(>150 bpm) but minimum pumping action; marginal ventricular
tachycardia (between 120 and 150 bpm--referred to as "walking
VTs"); noise; and non-determinate signals, which are described
below. The invention may use one or more well-known analysis
algorithms to make these determinations. However, in preferred
embodiments of the invention, ECG analysis module 87 performs the
algorithm shown in FIG. 16.
[0142] The algorithm shown in FIG. 16 essentially includes three
stages, ECG input and prefiltering stage 150, arrhythmia risk
assessment stage 151, and therapy decision algorithm stage 152. ECG
input and prefiltering stage 150 includes preconditioning filter
step 154, during which baseline stabilizer processing, noise
filtering, bandpass filtering, and auto-gain control are performed
on the patient's input ECG data. In preferred embodiments, at least
some of these functions are performed in hardware in patient
measurements block 56 (e.g., ECG filter 119 and ECG amplifier 92
described below with respect to FIG. 13). Following preconditioning
filter step 154, the ECG data is then transmitted to both rhythm
analysis step 156 and fault detection step 157.
[0143] Rhythm analysis step 156 detects peaks in the patient's ECG,
a beat morphology of the patient's heart, and a rhythm interval of
the patient's heart. Fault detection step 157 determines a noise
level estimate for noise in the patient's ECG, the electrode
quality, meaning connection of electrodes 31 to the patient, and
the patient's ECG signal amplitude. Results from steps 156 and 157
are provided to preliminary decision matrix 158 which makes a
preliminary determination, based on the information provided from
steps 156 and 157 and based on stored patient parameters, whether
the patient's ECG comprises a benign rhythm, a complex rhythm, or a
rhythm that constitutes a risk of arrhythmia. This preliminary
determination is then provided to periodic arrhythmia review step
160. Periodic arrhythmia review step 160 samples the input ECG data
for fixed time intervals (e.g., 10 to 20 seconds), or at variable
time intervals for arrhythmias which are preliminarily determined
to be complex. This data, along with the preliminary determination
made in preliminary decision matrix 158, is then passed along to
arrhythmia risk assessment stage 151, specifically to rhythm
analysis step 161.
[0144] Rhythm analysis step 161 performs segment morphology
analysis on data received from periodic arrhythmia review step 160,
and also performs a temporal analysis of the results of the segment
morphology analysis. Processing then proceeds to decision matrix
162 which either confirms or refutes the preliminary decision made
in preliminary decision matrix 158 based on the processed data and
stored patient parameters. Specifically, decision matrix 162 either
confirms or refutes that the patient's ECG comprises a benign
rhythm, an arrhythmia, or a complex rhythm. Processing then
proceeds to therapy decision algorithm stage 152, specifically to
rhythm analysis step 164. Rhythm analysis step 164 processes the
patient's ECG data by performing thereon, a Fourier analysis, a
power spectral analysis, spectral analysis extraction, and a
multi-variate temporal analysis.
[0145] The processed ECG data output from rhythm analysis step 164
is then provided to noise analysis step 166. Noise analysis step
166 performs adaptive noise discrimination on the processed ECG
data, and then performs noise identification and classification so
as to characterize noise in the data. For example, the noise may
comprise artifact nose, noise from an internal pacemaker, etc.
Thereafter, processing proceeds to decision matrix 167. Decision
matrix 167 either confirms that the patients ECG is a benign
rhythm, in which case decision matrix 167 merely permits continued
monitoring of the patient's ECG, or declares that there is an
arrhythmia. The results of decision matrix 167 are then output to
therapy decision step 169, which determines whether to provide
defibrillation energy to the patient based on the results of
decision matrix 167, together with patient physiologic measurements
provided by step 170. These physiologic measurements include
consciousness detection, hemodynamic assessment, and stimulus
response tests.
[0146] By virtue of the foregoing, ECG analysis module 87 is able
to differentiate "treatable rhythms", meaning ECG and physiologic
analysis results which warrant application of therapy, from
"non-treatable rhythms", meaning ECG and physiologic analysis
results which do not warrant application of therapy. Non-treatable
rhythms include normal sinus rhythms, supraventricular tachycardia,
atrial fibrillation (with or without bundle branch block), atrial
flutter, second and third degree heart block, ventricular ectopy,
premature ventricular contractions, and pacing (see below). ECG
analysis module 87 is also capable of recognizing spontaneous
organized cardiac rhythms that frequently follow defibrillation,
and are associated with the presence of pulse and blood pressure.
These rhythms are also classified as non-treatable. Treatable
rhythms include ventricular fibrillation (coarse), and high rate
ventricular tachycardia that are hemodynamically compromised and
result in patient unconsciousness. For ventricular fibrillation,
the peak-to-peak amplitude should be greater than 150 .mu.V for the
rhythm to be considered treatable, and for a ventricular
tachycardia the patient's rate must exceed the corresponding
patient parameter, namely the patient parameter corresponding to
the ventricular tachycardia rate at which defibrillation energy (or
a cardio signal (i.e. a low-energy defibrillation signal)) is to be
delivered to the patient.
[0147] When identifying treatable versus non-treatable rhythms, the
foregoing process errs on the side of caution, meaning that it is
more likely that the ECG analysis module 87 will identify a
non-treatable rhythm as treatable, than identify a treatable rhythm
as non-treatable. This feature is built into the system as a safety
measure, so that the likelihood of misidentifying a
life-threatening arrhythmia is reduced.
[0148] ECG analysis module 87 is also able to identify other
rhythms. These include non-determinative rhythms and pace rhythms.
Pace rhythms correspond to heart rates that are sustained below 30
bpm and which result in patient unconsciousness. These rhythms are
treated with a pacing signal, as opposed to a full
defibrillation/cardio signal. Non-determinate rhythms comprise
rhythms which require additional analysis to make a definitive
decision as to whether defibrillation is required in response
thereto. Such rhythms may be the result of extraneous artifact
noise in the patient's body caused, e.g., by muscle contractions
resulting from movement. In the event that ECG analysis module 87
is unable to differentiate between extraneous noise and the
patient's ECG, ECG analysis module 87 notifies master control
module 90 which, in turn, outputs a message to visual indicator 42
and/or auditory indicator 44.
[0149] In addition to the foregoing, ECG analysis module 87 is able
to determine, based on electrode-to-skin impedance data received
from electrodes 31 and the electrode-to-skin impedance range stored
in data logging memory block 57, whether and which electrode in
electrode harness 4 has become detached from the patient. To this
end, patient measurements block 56 preferably monitors separate,
identifiable terminals which permits ECG analysis module 87 to
identify inputs from particular electrodes in electrode harness 4.
In the case that one or more of these electrodes has become
detached from the patient, ECG analysis module 87 passes such
information along to master control module 90. ECG analysis module
87 is also able to determine whether electrodes are attached to the
patient's skin based on thoracic impedance measurements. That is,
if the patient's thoracic impedance is determined to be above a
predetermined value, such as 200 ohms, ECG module ascertains that
the electrodes are no longer attached to the patient.
[0150] ECG analysis module 87 also determines the patient's heart
rate and "R-wave synchronization trigger" based on received ECG
information. In this regard, R-waves are present in the patient's
ECG, both intrinsically and, in some cases, due to an internal or
external pacemaker. Transmission of defibrillation signal (in this
case a cardio signal) to the patient must be synchronized with an
R-wave in order to avoid triggering ventricular fibrillation during
a vulnerable period of the patient's ventricles. This vulnerable
period occurs during repolarization of the ventricles, and usually
begins 30 to 40 msec before the apex of a T-wave in the patient's
ECG, and ends near the apex of the T-wave. If ventricular ischemia
is present, the vulnerable period starts approximately at the same
time, but may persist for as long as 120 msec after the end of the
T-wave. In all cases, however, the onset of the vulnerable period
follows the peak of the R-wave by an amount of time that depends on
the patient's heart rate and on the patient's ECG. The onset ranges
from approximately 220 msec at a heart rate of 60 bpm to 120 msec
and to as low as 100 msec at a heart rate of 150 bpm. The R-wave
synchronization trigger determined by ECG analysis module 87 is
used by master control module 90, described below, to synchronize
the defibrillation energy so that the defibrillation energy is not
applied during these vulnerable periods. Specifically,
defibrillation energy is synchronized so that it is delivered
within 60 msec of the patient's R-wave peak, if one is present. If
no R-wave is detected within a 500 msec monitoring window, then the
defibrillation energy is transmitted at the end of this window. In
determining the R-wave synchronization trigger, ECG analysis module
87 disregards stand-alone pacemaker pulses, meaning that only the
heart's reaction to these pulses is factored into determination of
the R-wave synchronization trigger, and not the pacemaker pulses
themselves.
[0151] Master control module 90 integrates patient information from
ECG analysis module 87, patient responsiveness from user interface
47, and outputs to auditory indicator 44, visual indicator 42, and
LED 41. FIG. 12 is a flow diagram which provides an overview of
this aspect of master control module 90's operation, including some
operational aspects of ECG analysis module 87. In step S1201 of the
flow diagram, master control module 90 receives analysis results
from ECG analysis module 87, which indicate whether the patient has
suffered an arrhythmia, the type of arrhythmia that the patient has
suffered, and whether the arrhythmia is life threatening. Master
control module 90 also receives information concerning the
patient's thoracic impedance. As described below, this information
is used to determine the amplitude of the defibrillation energy to
be transmitted by defibrillator 10.
[0152] After step S1201 receives the ECG analysis results and
impedance information, processing proceeds to step S1202, which
determines whether the analysis results indicate that the patient
has suffered a life-threatening arrhythmia. In a case that step
S1202 determines that the patient has not suffered a
life-threatening arrhythmia, processing proceeds to step S1203.
Step S1203 issues commands to output a message, such as "SEE A
DOCTOR", to the patient, in the form of audio and visual signals
via audio indicator 44 and visual indicator 42, respectively.
Thereafter, processing returns to step S1201.
[0153] On the other hand, in the case that step S1202 determines
that the patient has suffered a life-threatening arrhythmia,
processing proceeds to step S1204. Step S1204 determines whether
other pre-conditions have been met before defibrillation energy is
transmitted to the patient. Specifically, step S1204 determines
whether the patient's thoracic impedance is within a predetermined
range, preferably between 15 and 200 ohms, and whether the
patient's ECG has been confirmed by, e.g., both ECG 1 and ECG 2
above taking into account artifact noise in the patient's body. In
a case that step S1204 determines that these pre-conditions have
been met, processing proceeds to step S1205; otherwise processing
proceeds to steps S1203 and back to step S1201.
[0154] Step S1205 determines whether the patient is conscious. More
specifically, in step S1205, master control module 90 outputs a
message (e.g., a query) such as "ARE YOU THERE". This message is
output both visually and audibly. After the message is output,
master control module 90 waits a predetermined period of time for a
response signal. This response signal may be input by the patient
via user interface 47, specifically, by pressing the response
button. In a case that master control module 90 detects the
response signal within the predetermined period of time, master
control module 90 ascertains that the patient is conscious. Since
defibrillator 10 does not administer defibrillation energy to
conscious patients, in this case, master control module 90 will not
cause defibrillation energy to be transmitted to the patient.
Instead, processing proceeds to step S1203, in which master control
module simply issues instructions to the patient, which can vary
depending upon the severity of the arrhythmia.
[0155] Thus, by pressing the response button, transmission of
defibrillation energy to the patient is averted. In this regard,
transmission of the defibrillation energy can also be averted upon
detection of certain errors in the defibrillator, disconnection of
electrode harness 4 from defibrillator 10, and removal of sensing
electrodes 31 from the patient.
[0156] In step S1205, in a case that master control module 90 does
not detect a response signal within the predetermined period of
time, master control module 90 issues another audio or visual
message (e.g., a louder message). After this second message has
been transmitted to the patient, master control module 90 again
waits for a response from the patient. In a case that the patient
does not respond to this second message within a predetermined
period of time, master control module 90 issues a third message to
the patient. This message can be a still louder message or can
include a tactile stimulation signal which is transmitted via an
electrode on the patient. If the patient does not yet respond,
master control module 90 issues a fourth and final message together
with a tactile stimulation signal. In this regard, it is noted that
the format of these four messages can vary. For example, verbal
messages need not be louder, the tactile stimulation signal can
increase in intensity with each message or may be applied at each
message, etc. Moreover, there need not be four messages. Rather,
there can be more or less messages, as desired.
[0157] In the event that the patient responds to none of the
foregoing messages, master control module 90 ascertains that the
patient is unconscious. In this case, processing proceeds to step
S1206, in which case master control module 90 immediately
thereafter issues a command to defibrillation control module 86
instructing that the defibrillation energy be transmitted to the
patient. That is, in preferred embodiments of the invention, as
soon as the patient is determined to be unconscious, master control
module causes defibrillation energy to be transmitted to the
patient immediately, without waiting for further input from the
patient, a clinician, or other party. Included with the command to
transmit the defibrillation energy is data defining the amplitude
and duration of phases in the defibrillation energy. Master control
module 90 determines this information based on the measured
thoracic impedance of the patient (see, e.g., Table 1 above).
[0158] In preferred embodiments of the invention, the defibrillator
trains patients with periodical tests in use of the response button
via a response test training protocol. Clinicians introducing the
defibrillator to new patients are able to initiate execution fo the
protocol from an attached clinician station (not shown). The same
protocols that are be used to periodically test (and train)
patients whenever the electrodes are replaced. The protocol is
based on first two alert levels (described below) and an imminent
response protocol (i.e., when the patient must response to a
message from the defibrillator) so that the patient learns and
becomes familiar with the first part of the imminent response
protocol. The patient learns what the voice message prompt sounds
like at Level 1, and learn what the Level 2 combined voice and
tactile simulation signal sounds and feels like. The repetition of
the Level 2 prompts is to ensure that the patient was given more
than enough time to response. The response/test training protocol
serves to develop a habitual reaction in the patient to the push
response button in response to voice and tactile stimulation signal
prompts during a potential rescue situation; regularly expose the
patient to the "PLEASE RESPOND" voice menage prompt at Level 1,
Level 2 with tactile stimulation signal if they do not respond to
the first prompt; indirectly show the patient that before
electrical therapy will be applied to them, they will be exposed to
a series of voice and tactile stimulation signals to confirm that
the patient is unconscious each time the test is performed,
establish that the defibrillator is generating the voice and
tactile stimulation prompts and that the patient can hear/feel
them, can respond, and the defibrillator is registering the
response; each time, record how fast the patient is responding to
the prompts; and each time, determine that patient interface is
working and, otherwise, declare the defibrillator unusable.
[0159] In some embodiments of the invention, in a case that a
patient is determined to be unconscious, master control module 90
may also cause a message, such as "STAND BACK", to be output prior
to defibrillation so as to advise bystanders of an upcoming
defibrillation. In this regard, other messages may be provided to
bystanders as well. For example, it is possible to output a message
such as "CALL FOR HELP" in the event that a patient wearing the
defibrillator is unconscious. Such a message may even be output
after defibrillation energy is administered to the patient. In this
regard, any number of different types of messages may be included
in the invention, which may be output at any time during the
defibrillation process.
[0160] In addition to applying defibrillation energy to the
patient, master control module 90 also determines when it is time
to provide a pacing signal to the patient, and applies that signal
accordingly. This process is similar to the above process for
applying defibrillation energy. That is, in a case that master
control module 90 determines that a patient's heart rate is below
30 bpm and the patient is unconscious, a pacing signal may be
applied via the electrode harness 4.
[0161] Defibrillation control module 86 controls defibrillation
control block 66 and charge control block 71 in accordance with the
command received from master control module 90 so that
defibrillation energy which is appropriate for the patient can be
generated and transmitted to the patient.
[0162] Regarding the remaining software modules executing within
processing block 64, diagnostics module 84 performs diagnostics on
defibrillator 10 relating to the operation and safety thereof prior
to transmitting defibrillation energy to the patient. These
diagnostics include diagnostics that are performed at power-on of
defibrillator 10 in order to determine if there are operational
defects therein. In a case that diagnostics module 84 detects
operational defects as a result of these diagnostics, this
information is stored in data logging memory block 57 and is
transmitted back to master control module 90, which alerts the
patient. Such information also may be transmitted to base station 2
or to personal computer 6.
[0163] Data recording module 82 controls transmission of data
between defibrillator 10, base station 2 and computers 6 and 210.
This data can include as noted above, abnormal heart activity of
the patient; the patient's ECG before, during and after application
of defibrillation energy; analyzed ECG conditions; ECG markings,
including defibrillation synch, external pace pulse, high slew
rate, and saturation; patient thoracic and electrode-to-skin
impedance measurements over time; voice, tone, and buzzer prompts;
displayed messages; information concerning patient interaction with
the defibrillator 10; transmitted defibrillation waveform
measurements, including current and voltage versus time; execution
time measurements of defibrillator 10 for use in determining if
defibrillator 10 operated as expected; detected operational errors
of defibrillator 10; calibration data for defibrillator 10; the
serial number of defibrillator 10; a harness identification ID of
an electrode harness interfaced to defibrillator 10; cold and warm
start information for defibrillator 10; artifact noise in the
patient; data from an accelerometer relating to motion of the
patient; and patient parameters. Data recording module 82 also
controls storage of the foregoing data in data logging memory block
57.
[0164] FIG. 13 is a block diagram showing representative hardware
used to implement the functions of defibrillator 10 described above
with respect to the FIG. 8. The hardware components shown in FIG.
13 include processor board 91, which is comprised of ECG amplifier
92, flash memories 94, program ROM 96, static RAM (hereinafter
"SRAM") 97, backup battery 99, voice chip 100, LCD circuit 101,
processor field programmable gate array (hereinafter "FPGA") 102,
voice driver 103, output circuit 104, reset/watchdog circuit 106,
power supply monitor 107, microprocessor 109, control FPGA 110,
address and data bus 111, crystal oscillator 112, and RTC 113. Also
included within defibrillator 10 are capacitors 69, transformer
114, power supply 20, input circuitry 116, output circuitry 117,
ECG filter 119, and accelerometer 120.
[0165] Generally speaking, processor 109, processor FPGA 102 and
control FPGA 110 perform the functions of processing block 64;
flash memories 94 perform the functions of data logging memory
block 57; control FPGA 110 performs the functions of defibrillation
control block 66, charge control block 71, and charger 70;
processor FPGA 102, input circuitry 116, ECG filters 119,
accelerometer 120, and ECG amplifiers 92 perform the functions of
patient measurements block 56; and control FPGA 110, together with
a serial interface (not shown) and a non contact interface (not
shown), perform the functions of accessory communications block 59.
Remaining hardware components of FIG. 13 that perform the functions
shown in FIG. 8 are self-evident
[0166] The hardware components shown in FIG. 13 are all tied to an
internal, "floating" ground during operation of defibrillator 10.
This means that there are no connections to an external ground when
defibrillator 10 is interfaced to a patient (although there may be
external ground connections when defibrillator 10 is interfaced to
base station 2). The use of floating grounds during operation of
defibrillator 10 is important from the patient's perspective, since
it reduces the chances of unwanted electric shock to the patient.
This floating ground may be on power supply 20, which was described
above. A detailed description of power supply 20 is therefore
omitted here for the sake of brevity. Suffice it to say that power
supply 20 provides power to all components on defibrillator 10,
including processor board 91, input circuitry 116, and capacitors
69.
[0167] Accelerometer 120 measures a patient's motion and provides
this information to processor 109 via control FPGA 110. Processor
109 analyzes the information received from accelerometer 120,
stores information relating to patient motion, and uses this
information in its calculations of artifact noise noted above.
[0168] Input circuitry 116 receives signals from each of sensing
electrodes 31, negative and positive inputs from power supply 20,
and a connector ID from an interfaced device. Input circuitry 116
also controls output of defibrillation, tactile stimulation and
pacing signals to a patient. To this end, included within input
circuitry 116 are a plurality of switches, one corresponding to
each input/output. These switches open and close in response to
instructions from processor board 91 so as to ensure that signals,
such as the defibrillation energy, are not inadvertently
transmitted to a patient. Input circuitry 116 also includes
shielding and the like on its input/output signal lines so as to
reduce the chances of damage to defibrillation circuitry during
application of defibrillation energy to the patient.
[0169] Signals received from input circuitry 116 are transmitted to
ECG filter 119. ECG filter 119 comprises plurality of bandpass
filters used to filter signals received from electrode harness 4.
These filtered signals are transmitted to ECG amplifier 92 on
processor board 91. ECG amplifier 92 includes amplifying circuitry
for amplifying the filtered signals received from ECG filter 119,
and an analog-to-digital converter for converting the amplified
signals from analog form into digital form. These digital signals
are then transmitted to processor 109 via processor FPGA 102.
[0170] Processor 109 receives clocking signals from crystal
oscillator 112, which preferably provides signals up to 40 MHz.
Processor 109 can comprise a microprocessor, microcontroller, or
the like, and is used to execute the software modules-described
above so as to control operation of defibrillator 10. Examples of
microprocessors which have been identified as suitable for use with
the present invention include the Intel 196 processor family, Intel
386EX (386EXTB), TMS320F206, Motorola 68332, the TI "2.times.3"
family DSP Processor, Amtel 8051 or equivalent, Hitachi 8/500
series, Mitsubishi M37700, and Motorola 68HC16, to name a few.
Processor 109 also controls the application of power to other
components in defibrillator 10, particularly those on processor
board 91, and is able to cause these components to be powered-up
and powered-down for predetermined time intervals. This feature of
the invention reduces the amount of power consumed by defibrillator
10.
[0171] As another power saving feature, processor 109 is capable of
operating in different modes, during which processor 109 consumes
different amounts of power. Specifically, processor 109 is operable
in a normal mode, during which processor 109 samples data from
electrodes 31 and controls defibrillator 10 in the manner described
herein. Processor 109 is also operable in a low-power mode. In some
embodiments of the invention, processor 109 may be turned off
completely. In preferred embodiments, however, most processing in
processor 109 ceases, but some elementary routines remain running.
During the low-power mode, all internal registers in processor 109
retain their data, thereby making it possible for processor 109 to
resume normal operation upon re-entering the normal mode. Processor
109 enters the low-power mode periodically, e.g., at intervals of 1
to 2 ms, for predetermined periods of time, e.g., 20 ms.
Alternatively, processor 109 can operate in the low-power and
normal modes at equal intervals, such as every 4 ms.
[0172] In preferred embodiments of the invention, the length of
time that processor 109 operates in the low-power mode is variable
based on information received from the patient or, alternatively,
based on information received from central repository 9. For
example, if processor 109 determines based, e.g., on the patient's
ECG and previous history, that the patient is at a relatively low
risk for a cardiac arrhythmia, processor 109 can lengthen the
period of the low-power mode. Likewise, if processor 109
determines, based on similar information, that the patient is at a
high risk for an arrhythmia, processor 109 can shorten, or even
eliminate, the low-power mode.
[0173] Another feature of the low power mode is that the amount of
power consumed therein may be varied. For example, in a case that
processor 109 determines that benign rhythms have occurred for a
relatively long time, processor 109 may enter a "deep" low power
mode, in which processor 109 is off, or in which only the most
elementary of routines remain running. On the other hand, in a case
that processor 109 determines that a treatable rhythm occurred
recently, processor 109 may enter a "light" low power mode, in
which less power is consumed than when the processor operates in
the normal mode, but in which more than just elementary routines
remain running in the processor.
[0174] To enter the low-power mode, in preferred embodiments of the
invention, processor 109 simply executes an "IDLE" instruction,
during which most internal processing in processor 109 is disabled.
In response to this IDLE instruction, processor 109 stops its
internal clock and may execute only low-level routines so as to
perform minimal tasks, such as determining when it is time to
re-enter the normal mode. To this end, in the low-power mode,
processor 109, via control FPGA 110 (described below), monitors
signals received from RTC 113 and, based on these signals,
determines when it is time to re-enter the normal mode. In a case
that defibrillator 10 includes a button or the like (not shown) on
its user interface for placing processor 109 in the normal mode
manually, processor 109 also monitors such a button during the
low-power mode.
[0175] Flash memories 94 comprise removable EPROMs or the like.
Program ROM 96 stores the software modules described above with
respect to FIG. 8 which are executed by processor 109. Static RAM
97 comprises a memory out of which those software modules may be
executed. As described above, SRAM 97 is backed-up by backup
battery 99. In this regard, backup battery 99 contains a
rechargeable lithium coin cell battery which is sufficient to back
up both RTC 113 and SRAM 97. Battery backup 99 may also be used to
supply power to power annunciator 46. Alternatively, a second
backup battery (not shown) may be used for this purpose.
[0176] Reset/watchdog circuit 106 monitors processor 109 and
control FPGA 110 in order to determine if either processor 109 or
control FPGA has lost program control. For example, in a preferred
embodiment of the invention, control FPGA 110 outputs a square wave
signal called WATCHDOG_OUT in a case that control FPGA 110 and
processor 109 are communicating properly. Reset/watchdog circuit
106 monitors this signal for variations therein. In a case that
this signal is interrupted, or has an unexpected waveform,
reset/watchdog circuit 106 ascertains that there has been a system
malfunction. As another example, processor 109 is programmed to
generate a signal called CONTROL_PLD_FAULT in a case that control
FPGA 110 has failed. Reset/watchdog circuit 106 monitors for this
signal as well in order to ascertain if there has been a failure in
control FPGA 110.
[0177] In the event that either processor 109 or control FPGA 110
has failed, a system reset will be attempted by reset/watchdog
circuit 106. If the problem persists, reset/watchdog circuit 106
will instruct output circuit 109 to output an alarm, e.g., a "tone"
or a "buzzing" via annunciator 46. In this regard, in the event of
a system error which causes a reset to be asserted, an alarm will
not be sounded immediately. That is, if the system successfully
recovers after one reset, no alarm will be sounded. This design
allows the system to rebound from a temporary fault without
alerting the user unnecessarily. If, however, a persistent fault
condition exists which reasserts itself for at least 200 msec per
second, the alarm is sounded for 5 to 10 seconds. If the system
subsequently recovers, the alarm will cease to sound at the
conclusion of this 5 to 10 second period; otherwise, the alarm will
continue as long as the system reset signal is asserted for 200
msec or more per second, stopping only when the backup battery for
annunciator 46 has been drained.
[0178] The system will also reset itself if power output by power
supply 20 drops below a predetermined level or goes above a
predetermined level. To determine if power supply 20 has gone below
or above these predetermined levels, power supply monitor 107
monitors power supply 20. In preferred embodiments of the
invention, power supply monitor comprises plural comparators with
associated circuitry for making these determinations. In a case
that power supply 20 is low, or is outputting greater than a
predetermined amount of power, this information is transmitted to
reset/watchdog circuit 106. In response, reset/watchdog circuit 106
causes annunciator 46 to output an alarm via output circuit 104. In
a case that power supply 20 has failed, processor 109 shuts down
defibrillator 10 just after reset/watchdog circuit 106 has caused
annunciator 46 to output the alarm.
[0179] Processor board 91 also includes control FPGA 110 and
processor FPGA 102, which comprise glue logic for controlling
inputs to, and outputs from, processor board 91. Processor FPGA 102
contains memory page registers, glue logic, and processor internal
clock stopping/starting circuitry. This clock stopping/starting
circuitry stops an internal clock of processor 109 for
predetermined periods of time, such as 4 msec, during processor
109's low-power modes. Processor FPGA 102 also controls outputs to
LED 41, auditory indicator 44 and visual indicator 42 (see FIG. 8).
In this regard, interfaced to processor FPGA 102 is voice chip 100,
e.g., an ISD33000 series Chip Voice Record/Playback device which
can store up to 60 seconds of prerecorded voice messages. Voice
driver 103 is also required to drive auditory indicator 44. An
example of such a driver is a TI TPA4861D (SOIC-8). Defibrillator
10 also includes LCD controller/driver 101 which, in preferred
embodiments of the invention, is an OKI MSM6555B or MISM6665
chip.
[0180] Control FPGA 110 contains a defibrillator state machine and
various registers for controlling operations of defibrillator 10.
Among these registers are capacitor configuration registers (not
shown). By writing into these registers, capacitors 69 can be
programmed to enable different capacitor configurations, i.e., the
221, 2111 or 11111 configurations shown in FIGS. 9 to 11. More
specifically, control FPGA 110 includes CAP_SW1, CAP_SW2, CHRGELCB
and CHARGE registers. Writing a "1" into the CHARGE register
enables capacitor charging, whereas writing a "0" into the CHARGE
register disables charging. Writing a "1" into the CHRGELCB
register switches all capacitors into a parallel configuration for
charging, whereas writing a "0" into the CHRGELCB register charges
only one of capacitors 60 and allows that one of capacitors 69 to
be placed into a series configuration for transmitting a tactile
stimulation or pacing signal. Writing a "1" into the CAP_SW1
register switches two of capacitors 69 into a series configuration,
whereas writing a "0" into CAP_SW1 register switches the two of
capacitors 69 into a parallel configuration. Writing a "1" into the
CAP_SW2 register switches two others of capacitors 69 into a series
configuration, whereas writing a "0" into CAP_SW2 register switches
the two others of capacitors 69 into a parallel configuration.
Thus, values in CAP_SW1 and CAP_SW2 control the configuration of
capacitors 69 during a defibrillation.
[0181] Control FPGA 110 comprises a plurality of other registers as
well, including a defibrillator control register. Bits are written
to the defibrillator control register to set defibrillator 10 to
provide either defibrillation energy, a tactile stimulation signal,
or a pacing signal. Control FPGA 110 also has a number of other
functions, including monitoring the charge in capacitors 69 and
adjusting the charge based on signals (e.g., patient impedance)
received from an interfaced device such as electrode harness 4,
monitoring inputs from user interface 47, e.g., the response
button, and providing output via a serial interface (not shown) to
base station 2 and via a non-contact interface (not shown) to
personal computer 6.
[0182] As noted above, outputs from control FPGA 110, namely CAPSW1
and CAPSW2, control switching of capacitors 69 from the 11111
configuration into the 2111 and 221 configurations. FIG. 14 shows a
detailed circuit diagram of capacitors 69 (and of transformer 114).
In preferred embodiments of the invention, the circuitry shown in
FIG. 14 fits on a circuit board having a surface area of roughly 2
inches.sup.2 or less. As shown in FIG. 14, capacitors 69a, 69b,
69c, 69d and 69e are charged by power supply 20 via transformer
114. CAPSW1 controls switching of capacitors 69b and 69c via
transistor switch 122, whereas CAPSW2 controls switching of
capacitors 69d and 69e via transistor switch 124. As noted above,
this switching controls the overall, combined capacitance of 69a,
69b, 69c, 69d and 69e, which affects the amplitude and the tilt of
a waveform output therefrom. Additional signal conditioning and
output circuitry is also shown in FIG. 14 but, since this
particular circuitry is not essential to the invention, a detailed
description thereof has been omitted for the sake of brevity.
[0183] It is worth noting, however, that FIG. 14 also shows
circuitry 126 which is used to output tactile stimulation and
pacing signals from capacitor 69a. As shown in FIG. 14, PACEP and
TENSP, which are output by control FPGA 110, control application of
the pacing and tactile stimulation and signals, respectively, from
capacitor 69a. That is, charge from capacitor 69a, namely CAP1+127,
is applied to circuitry 126 and processed for output as the pacing
or tactile stimulation signal. FIG. 14 also shows the CHARGELCB
signal, which was described above, and ISNSCB and IDSNSCB signals.
The ISNSCB signal comprises a current sense signal which is used to
determine the charge of capacitors 69, whereas the IDSNSCB signal
is used to determine the defibrillation energy current. This
information is passed back to processor board 91, which processes
this information and responds in the manner described above. For
example, in the event that processor 109 determines that capacitors
69 are charged excessively for a particular patient such that
over-current or even over-time defibrillation could occur,
defibrillator 10 may be shut down or temporarily disabled so that
capacitors 69 can be discharged without harm to the patient.
[0184] Returning to FIG. 13, output circuitry 117 includes signal
conditioning circuitry as well as control circuitry which ensures
that defibrillation energy will not be output inadvertently. In
this regard, the invention also includes other safety features
which limit transmission of the defibrillation control signal. For
example, prior to delivery of the defibrillation energy, processor
109 monitors and demonstrates that state control clocks controlling
the defibrillation energy are operational, and also tests the
hardware components in order to detect any single point failures
therein. These tests include testing switches in input circuitry
116, through which the defibrillation energy is transmitted. These
switches are tested, one at a time, to demonstrate that each switch
is capable of holding off a full magnitude of the defibrillation
energy. At each step of this switch test, a voltage across each
transistor (i.e., switch) is monitored to record a test voltage and
to record a transistor gate drive time constant in addition to
combined opto isolator and transistor turn-off times. These
voltages are then used to measure patient voltage during
application of the defibrillation energy. Upper transistor
switches, through which the defibrillation energy is transmitted,
are tested first, followed by lower transistor switches. Each
transistor switch is monitored and tested to demonstrate that the
defibrillation energy would be terminated independently of hardware
control timing.
[0185] In addition, as noted above, two pre-conditions must be met
before defibrillation energy is transmitted the patient, namely,
(i) the patient has experienced a treatable rhythm and (ii) the
patient is unconscious. When these two conditions occur, processor
109 arms the defibrillation controller, e.g., control FPGA 110.
Specifically, processor 109 provides the following sequence of
control signals to initiate arming of the defibrillation
controller. First, processor 109 tests its own internal safety
signal ("PD_SAFE") to demonstrate its ability to override any
hardware defibrillation control signals. Processor 109 then
confirms that defibrillation energy can be detected properly by
activating test signals and reading current feedback signals based
on these test signals. Master control module 90, executing within
processor 109, sets a "defibrillator arm request status" bit in
memory for use and checking by an executive control module (not
shown). This executive control module monitors operation of the
software and updates a watchdog timer in processor 109 (which
outputs the WATCHDOG_OUT signal noted above) when the software is
confirmed to function properly. The executive control module then
sets an arm request signal in the defibrillation controller and
calls a watchdog update subroutine which transitions the signal
output from the watchdog timer. This causes a watchdog timer update
and transitions the "armed request" status to the "armed" status in
the defibrillation controller. The PD_SAFE signal is then put in
the active state to allow the activation of hardware control
signals for defibrillation therapy.
[0186] Next, processor 109 provides a final synchronized trigger
signal to the defibrillation controller for delivery of the
defibrillation energy. This synchronized trigger signal will be
accepted only after the "armed" status has been established. The
defibrillation controller will clear the armed status if the
synchronization trigger signal is not provided within a 500 msec
time period, thereby providing a limited acceptable period for
defibrillation therapy. In a case that the defibrillation energy is
transmitted to the patient, following transmission thereof,
processor 109 determines if the defibrillation energy was
transmitted properly. In this regard, defibrillation energy dosage
errors of over-current are protected by the reset/watchdog circuit
described above, but, if such an event does inadvertently occur, a
fault condition is retained in a hardware fault register.
Similarly, under-dosages of the defibrillation energy are also
detected and stored. In addition to being stored, these and other
defibrillator operational errors may be transmitted to base station
2.
[0187] Diagnostics module 84 also performs a plurality of
diagnostics on defibrillator 10 to test defibrillator 10's
hardware. These diagnostics include cold start diagnostics, which
are executed when defibrillator 10 powers-up normally, warm start
diagnostics which are executed when defibrillator 10 experiences
transient reset or power loss, runtime diagnostics which are
continuing, periodic tests performed in the background of normal
operating conditions, and specific conditions diagnostics which are
tests that are performed prior to, or when certain operations are
performed, such as transmission of defibrillation energy.
[0188] Cold start diagnostics include RAM test, ROM test, D/A and
A/D converter tests, FPGA tests, RTC and ECG sampling rate tests,
LCD tests, voice circuitry tests, backup battery voltage tests,
primary power supply voltage tests, internal voltage tests, old
electrode harness test (i.e., whether the electrode harness has
been changed after transmission of defibrillation energy), safety
tests so as to verify that safety controls are operational,
watchdog timer tests, shutdown tests, and patient parameters
validation. Warm start diagnostics include operational state data
tests (protected RAM validation) and patient parameters validation.
Runtime diagnostics include watchdog timer active tests so as to
confirm that a clock signal is active, software clock to real time
clock comparison tests, software execution times checks, system
voltage tests so as to test if the system is within voltage
specifications, A/D runtime reference voltage tests, backup battery
voltage tests, primary power supply voltage tests, internal voltage
tests, old electrode harness test, operational state data integrity
test, operational temperature tests, lead off tests, stuck keys
test, safety tests including electrode harness time limit tests,
defibrillation capacitor voltage tests, defibrillation output
circuitry tests, output voltage tests, patient parameter
validation, and impedance measurements. Specific conditions
diagnostics include tests which are performed prior to transmission
of defibrillation energy to the patient. These tests include cross
checking processor tests whereby control FPGA 110 checks processor
109 for correct performance of a command sequence, and processor
109 checks control FPGA 110 for correct progression of states
during set-up and transmission of defibrillation energy. Other
tests include a watchdog timer test which resets the system in a
case that processor 109 fails to respond periodically,
electrodes-off tests in which processor 109 confirms that
electrodes are attached to the patient, operational therapy state
data integrity tests, pre-therapy dosage tests whereby energy to be
transmitted as defibrillation energy is compared with two impedance
measurements prior to transmission, stuck ECG relay contacts tests
(prior to defibrillation), H-bridge therapy tests, and delivered
defibrillation current limiting tests.
[0189] Base Station
[0190] In brief, a base station for use with the present invention
includes a defibrillator interface, over which information is
exchanged with the defibrillator, and an external interface over
which information is exchanged with an external entity, such as
central repository 9, a doctor's office, a hospital, etc. Also
included in the base station is a controller which receives patient
information and defibrillation information from the defibrillator,
transmits the patient information and defibrillation information to
the external entity, receives defibrillator programming information
from the external entity, programs the defibrillator in accordance
with the defibrillator programming information, performs
diagnostics on the defibrillator, and transmits results of the
diagnostics to at least one of the defibrillator and the external
entity. Communication between the defibrillator and the base
station may be via an RF, IR, or direct electrical connection. In
addition, communication/testing may be effected by direct contact
between the sensing electrodes and the base station.
[0191] A block diagram of base station 2 is shown in FIG. 15. As
shown, base station 2 includes, RAM 130, program memory 131, user
interface 132, non-volatile memory 133, defibrillator interface
134, external interface 136, controller 137, address/data bus 139,
and personal computer interface 140. Base station 2 may receive
power from an external source, such as a wall outlet, or from a
battery (not shown). Each of the features of base station 2 shown
in FIG. 15 is described in more detail below.
[0192] User interface 132 can comprise a keyboard, buttons,
switches, or the like, which provide a user with a way to control
base station 2 directly. Defibrillator interface 134 corresponds to
connector 51 shown in FIG. 1 and comprises an interface to
defibrillator 10, over which patient information (e.g., ECG
information) and defibrillator information (e.g., errors in
operation of defibrillator 10) is received from the defibrillator,
and over which external information (i.e., information received
from an external source, such as new patient parameters) is
transmitted to the defibrillator. Defibrillator interface 134
includes base station 2's physical connector ID. Defibrillator
interface 134 is preferably a serial interface and, as described
above, mates to the same connector on defibrillator 10 that is used
to interface defibrillator 10 to electrode harness 4.
[0193] Personal computer 6, which is interfaced to base station 2
via personal computer interface 140, may be used to indicate
operational characteristics of base station 2, such as when base
station 2 is uploading data, whether that upload was successful, a
display of all uploaded data, etc.
[0194] External interface comprises a link to an external location,
such as central repository 9 (see FIG. 1) or a personal computer,
over which patient and defibrillation information is transmitted to
the external source, and over which the external information is
received from the external source. External interface can comprise
a modem link, a network connection, or the like, over which data
may be transmitted to and from base station 2. At this point, it is
noted that all information stored in data logging memory block 57
above can be transmitted over defibrillator interface 134 and
external interface 136 of base station 2.
[0195] Controller 137 comprises a microprocessor or the like, which
is capable of executing stored program instructions so as to
control operation of base station 2. Any type of processor may be
employed, such as those described above with respect to
defibrillator 10. Program instructions that can be executed by
controller 137 are stored in program memory 131. Program memory 131
preferably comprises an EPROM, or the like, which can be
reprogrammed with newly-received information or routines by
controller 137. In preferred embodiments of the invention, program
memory 131 stores control module 140, diagnostics module 142, and
patient parameters 144, among other data and software modules.
[0196] Patient parameters 144 correspond to the patient parameters
described above and, as noted, can be reprogrammed based on
information, such as instructions, provided from an external
source. Control module 140 is executed so as to control transfer of
information between defibrillator 10, base station 2, and central
repository 9. Diagnostics module 142 comprises a module which
performs various safety diagnostics on defibrillator 10 when
defibrillator 10 is interfaced to base station 2. By way of
example, control module 140 may be executed to retrieve information
relating to operational errors of defibrillator 10 from data
logging memory block 57 of defibrillator 10. Diagnostics module 142
may then use this information to target-test components and/or
software on defibrillator 10 that may be responsible for these
errors. Alternatively, diagnostics module 142 may perform a
complete safety diagnostic check on all aspects of defibrillator 10
each time defibrillator 10 is mated to base station 2.
[0197] In this regard, base station 2 is capable of performing
diagnostics comprising an audio test to confirm that messages and
tones output by defibrillator 10 are clearly audible; measurement
tests to confirm that all measurements in defibrillator 10 needed
to perform a defibrillation procedure are as expected; ECG analysis
tests so as to confirm that defibrillator 10 is able to detect and
differentiate various cardiac arrhythmias; defibrillation waveform
tests so as to confirm that defibrillator 10 can generate and
output a waveform appropriate for a patient having a particular
impedance; patient leakage current tests so as to confirm that
leakage current in defibrillator 10 is not above an acceptable
level; over-dosage defibrillation tests so as to confirm that
defibrillator 10 will automatically terminate an over-current
defibrillation (e.g., I.sub.max.gtoreq.30 A) and an over-time
defibrillation (e.g., t.sub.max.gtoreq.20 msec); under-dosage
defibrillation tests so as to determine if defibrillator is
providing an under-current defibrillation (e.g., I.sub.max is less
than a required current for a patient's impedance measurement by
more than 20%) or an under-time defibrillation (e.g., t.sub.max is
less than a required duration for a patient's impedance measurement
by more than 20%); power consumption tests so to confirm that
defibrillator 10 meets with the power requirements set forth in
Table 2 below; and button switch tests to confirm that each button
on user interface 47 is operating properly.
2TABLE 2 Defibrillator Operating Conditions Current Constraint
Low-Power Mode <2 mA Patient Monitoring Only <20 mA Detection
of Ventricular Fibrillation <400 mA When any of the following
operations are active <900 mA i) Flash read/write ii) LCD iii)
Voice message/Tone iv) Accessory Communications Charging of
Capacitors <3.0 A
[0198] Diagnostics module 142 may also be executed to check proper
transmission of patient parameters or other programming information
from base station 2 to defibrillator 10. More specifically, in
operation, base station 2 receives new patient parameters over
external interface 136 from central repository 9, and transmits
these patient parameters over defibrillator interface 134 to data
logging memory block 57 in defibrillator 10. Diagnostics module 142
may then be executed to issue a request for the patient parameters
stored in data logging memory block 57 over defibrillator interface
134, to receive the patient parameters therefrom over defibrillator
interface 134, and to compare the patient parameters, including a
checksum, to the same patient parameters, which are stored in
program memory 131, so as to verify valid receipt of the patient
parameters by defibrillator 10.
[0199] In preferred embodiments of the invention, the results of
the foregoing diagnostics may be transmitted back to defibrillator
10 in order to warn the user of the defects via, e.g., an LCD or a
speaker. In addition, the results of such diagnostics may also be
transmitted to an external location via external interface 136 for
analysis or the like.
[0200] Base station 2 also includes RAM 130, out of which
controller 137 executes program instructions stored in program
memory 131, and non-volatile memory 133, which stores information
received from defibrillator 10 and from an external source.
Non-volatile memory 133 can comprise an NVRAM, battery backed-up
RAM, EPROM, or the like, and has a storage capacity which is the
same as or greater than that of data logging memory block 57 on
defibrillator 10. This is preferable, since non-volatile memory 133
should be capable of storing any information downloaded to base
station 2 from defibrillator 10, including all or part of the
information described above that is stored in data logging memory
block 57, i.e., abnormal heart activity of the patient, the
patient's ECG before, during and after application of
defibrillation energy, etc. In this regard, upon connection of
defibrillator 10 to defibrillator interface 134, in preferred
embodiments of the invention, controller 137 requests defibrillator
10 to upload data stored in data logging memory block 57 and, if
the data has been uploaded successfully, controller 137 requests
defibrillator 10 to reset all recorded data in data logging memory
block 57, and also to clear patient parameters stored therein to
their default settings.
[0201] As noted above, it is possible to reprogram defibrillator 10
and/or base station 2 with information received from the external
location. In fact, it is even possible to use information received
from defibrillator 10 to affect such reprogramming. More
specifically, information relating to patients using the same type
of defibrillator, i.e., defibrillator 10's type, is stored in
central repository 9. This information can be analyzed in order to
test algorithms used in defibrillator 10. One such algorithm that
may be tested is an algorithm used by ECG analysis module 87 above
to detect irregular heart activity. Once this algorithm is tested
based on analysis results from plural defibrillators, it is
possible to pinpoint errors in the algorithm, and to correct these
errors. Thereafter, the corrected algorithm can be transmitted back
to base station 2, as well as to a plurality of other base
stations. In this regard, central repository may identify base
station 2 as corresponding to defibrillator 10 based on
defibrillator 10's ID number. Base station 2 can then reprogram
defibrillator 10 using the corrected algorithm. As a result the
invention provides a means by which to improve its performance
based on information collected thereby.
[0202] The present invention has been described with respect to
particular illustrative embodiments. It is to be understood that
the invention is not limited to the above-described embodiments and
modifications thereto, and that various changes and modifications
may be made by those of ordinary skill in the art without departing
from the spirit and scope of the appended claims.
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