U.S. patent application number 16/465508 was filed with the patent office on 2020-02-27 for method and device for detecting heart rhythm irregularities.
The applicant listed for this patent is BIV MEDICAL, LTD., Shiming LIN. Invention is credited to Shiming LIN.
Application Number | 20200060562 16/465508 |
Document ID | / |
Family ID | 62241240 |
Filed Date | 2020-02-27 |
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United States Patent
Application |
20200060562 |
Kind Code |
A1 |
LIN; Shiming |
February 27, 2020 |
METHOD AND DEVICE FOR DETECTING HEART RHYTHM IRREGULARITIES
Abstract
A method for detecting heart rhythm irregularities, including
the steps of: measuring pulse peaks continuously over a period of
time to obtain pulse peak sequence and pulse peak time interval
sequence corresponding to the pulse peak sequence; and calculating
the absolute value of a difference between a single pulse peak time
interval in the pulse peak time interval sequence and an average
value of the pulse peak time interval sequence, and determining
that an irregular pulse peak (IPP) has occurred if the absolute
value is larger than or equal to 15% to 25% of the average value of
the pulse peak time interval sequence. A detection device using the
method is also provided. This uses a non-invasive approach to
detect heart rhythm irregularities such as sick sinus syndrome,
irregular pulse peaks, irregular heartbeat, and atrial
fibrillation, and can be applied to a sphygmomanometer or a
wearable device.
Inventors: |
LIN; Shiming; (Taipei,
TW) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LIN; Shiming
BIV MEDICAL, LTD. |
Taipei
Caotun Township, Nantou County |
|
TW
TW |
|
|
Family ID: |
62241240 |
Appl. No.: |
16/465508 |
Filed: |
November 29, 2017 |
PCT Filed: |
November 29, 2017 |
PCT NO: |
PCT/CN2017/113528 |
371 Date: |
May 30, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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62497740 |
Dec 1, 2016 |
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62497747 |
Dec 1, 2016 |
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62601843 |
Apr 4, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/046 20130101;
A61B 5/0235 20130101; F04B 39/123 20130101; F04B 43/02 20130101;
A61B 5/02141 20130101; A61B 5/0225 20130101; A61B 5/02208 20130101;
F04B 45/047 20130101; F04B 39/121 20130101; F04B 53/10 20130101;
A61B 5/681 20130101; A61B 5/02 20130101; A61B 5/021 20130101 |
International
Class: |
A61B 5/046 20060101
A61B005/046; A61B 5/022 20060101 A61B005/022; A61B 5/00 20060101
A61B005/00 |
Claims
1. A method for detecting heart rhythm irregularities, comprising
the steps of: a) measuring pulse peaks continuously over a period
of time to obtain a pulse peak sequence and a pulse peak time
interval sequence corresponding to the pulse peak sequence; and b)
calculating the absolute value of a difference between a single
pulse peak time interval in the pulse peak time interval sequence
and an average value of the pulse peak time interval sequence, and
determining that an irregular pulse peak (IPP) has occurred if the
absolute value is larger than or equal to 15% to 25% of the average
value of the pulse peak time interval sequence.
2. The method for detecting heart rhythm irregularities of claim 1,
wherein the method further comprises the step of: c) performing the
determination of the occurrence (or absence) of an irregular pulse
peak on each pulse peak time interval in the pulse peak time
interval sequence, calculating the ratio of the number of the
identified irregular pulse peaks to the total number of the time
intervals in the pulse peak time interval sequence, and determining
that irregular heartbeat (IHB) has occurred if the ratio is larger
than or equal to a threshold value.
3. The method for detecting heart rhythm irregularities of claim 1,
wherein the method further comprises the steps of: d) pausing for a
period of time, then measuring pulse peaks continuously over
another period of time to obtain a second pulse peak sequence and a
second pulse peak time interval sequence corresponding to the
second pulse peak sequence, and performing the foregoing
determination of the occurrence (or absence) of irregular
heartbeat; e) pausing for a period of time, then measuring pulse
peaks continuously over another period of time to obtain a third
pulse peak sequence and a third pulse peak time interval sequence
corresponding to the third pulse peak sequence, and performing the
foregoing determination of the occurrence (or absence) of irregular
heartbeat; and f) determining that atrial fibrillation (AF) has
occurred if at least two occurrences of irregular heartbeat are
identified in the three consecutive performances of the
determination of the occurrence (or absence) of irregular
heartbeat.
4. The method for detecting heart rhythm irregularities of claim 1,
wherein the determination of the occurrence of an irregular pulse
peak includes grading an irregular pulse peak according to the
percentage of the average value of the pulse peak time interval
sequence that the absolute value is larger than or equal to.
5. The method for detecting heart rhythm irregularities of claim 4,
wherein an irregular pulse peak is graded as a 15% irregular pulse
peak (IPP 15%) if the absolute value is larger than or equal to 15%
of the average value of the pulse peak time interval sequence, as a
20% irregular pulse peak (IPP 20%) if the absolute value is larger
than or equal to 20% of the average value of the pulse peak time
interval sequence, or as a 25% irregular pulse peak (IPP 25%) if
the absolute value is larger than or equal to 25% of the average
value of the pulse peak time interval sequence.
6. The method for detecting heart rhythm irregularities of claim 1,
wherein the method for detecting heart rhythm irregularities
determines that sick sinus syndrome (SSS) has occurred if a single
pulse peak time interval in the pulse peak time interval sequence
is longer than or equal to 3 seconds or if the pulse peak frequency
of the pulse peak time interval sequence is lower than or equal to
50 times per minute.
7. The method for detecting heart rhythm irregularities of claim 6,
wherein the detection is carried out with a sphygmomanometer that
measures blood pressure by the oscillometric method.
8. A detection device, comprising: a detecting portion for
measuring pulse peaks continuously over a period of time; a
recording portion for receiving and recording measurement data
obtained by the detecting portion; a processor for performing
computation on the measurement data in the recording portion and
for determining the occurrence of heart rhythm irregularities by
the method of claim 1; and a display device for displaying a
determination result of the processor.
9. The detection device of claim 8, wherein the detection device is
a sphygmomanometer that measures blood pressure by the
oscillometric method or the auscultatory method, or a smartwatch
that measures blood pressure/heart rhythm through an inflatable
bladder.
10. The detection device of claim 8, wherein the detecting portion
includes: a bladder adapted to be wrapped around a user's limb at a
position corresponding to an artery; an air pressure pump for
inflating the bladder; at least one pressure sensor for measuring
the pressure in the bladder; a pressure relief valve through which
air is discharged from the bladder; and a microcontroller unit for
controlling the operation of the air pressure pump and the pressure
relief valve.
Description
BACKGROUND OF THE INVENTION
1. Technical Field
[0001] The present invention relates to a method and device for
detecting heart rhythm irregularities. More particularly, the
invention relates to a method and device that measure pulse peaks
in order to detect an irregular pulse peak (IPP), irregular
heartbeat (IHB), atrial fibrillation (AF), and sick sinus syndrome
(SSS).
2. Description of Related Art
[0002] The human circulatory system is composed of the heart, blood
vessels, and blood, and is driven by contraction of the heart. Each
time the heart contracts, the blood in the left ventricle is
squeezed into the aorta and then into the other arteries in the
body. As the diameter of an artery increases with the pressure
therein when a large amount of blood enters the artery, the
contraction and relaxation of the ventricles in a cardiac cycle
causes arteries to expand and recoil (i.e., to pulsate) in a cyclic
manner. The pulsation of arteries that are relatively close to the
skin can be felt by hand and is known as the pulse.
[0003] Generally, a normal pulse is synchronous with heartbeat, and
an irregular pulse may arise from a clinical disease, especially
one related to the heart. Pulse measurement, therefore, is an
important physical examination item for those with, or prone to,
cardiovascular disease. A physician may also diagnose diseases
according to variation in the pulse.
[0004] Heart rhythm irregularities may take many forms, including
an abnormal pulsation frequency or rhythm of the heart, an abnormal
origin of cardiac impulse, an abnormal conduction velocity in the
heart, an abnormal sequence of excitation of the heart, and so on.
The mechanisms by which heart rhythm irregularities are formed can
be divided into two major categories: abnormal impulse formation
and abnormal impulse conduction. Heart rhythm irregularities caused
by abnormal impulse formation include those associated with the
sinus node such as sinus tachycardia, sinus bradycardia, sinus
arrhythmia, and sinus arrest; other examples include an escape
beat, paroxysmal tachycardia, atrial fibrillation, ventricular
fibrillation, and other ectopic rhythms. Heart rhythm
irregularities caused by abnormal impulse conduction include
sinoatrial block, sick sinus syndrome, atrioventricular block, and
so on. Of all the heart rhythm irregularities, atrial fibrillation
is the one that requires medical attention the most often because
it may increase the risk of heart failure, dementia, and
stroke.
[0005] To discover a heart rhythm irregularity as early as
possible, the first step is to monitor heart rate and heart rhythm
and determine whether they are regular, and to note the starting
time, ending time, and duration of any irregularity. Nowadays,
heart rate is generally monitored by measuring the electrical
potential of the heart or by photoplethysmography. The former
method is commonly known as electrocardiography (ECG), in which
electrodes are placed on the skin of a person's chest to record the
electrophysiological activities of the heart, or more particularly
to record the electrical potential difference of the cardiac cells
between the polarization and depolarization processes of each
heartbeat so that the rhythm of pulsation of the heart can be
derived accordingly. The latter method is currently in common use
in smart bracelets and works on the principle that blood absorbs
light of certain wavelengths. More specifically, a device projects
light to a user's skin, and the user's heartbeat is measured by
detecting variation of the light reflected from the skin. While the
ECG method provides the more accurate measurement result, the
operation and determination skills required are also more
sophisticated, not to mention the costly ECG equipment. As to
photoplethysmography, it is subject to interference from the
environment (e.g., the sweat on a user's skin and the degree of
contact between the sensor and the user's skin) and therefore has
relatively large measurement errors. Apart from the above,
sphygmomanometers can also be used to measure the pulse in the
following manner. A manually or automatically inflatable cuff is
wrapped around the arm, and the pulse is observed by means of a
resonance device or stethoscope while determining the systolic
pressure and diastolic pressure.
[0006] Today, monitoring devices that can take relatively accurate
measurement of the pulse or heart rate are generally bulky and
hence do not allow monitoring wherever and whenever desired. Smart
bracelets that claim to be capable of measuring or monitoring heart
rate in real time (based on measurement of the pulse) are indeed
available, but despite their portability, huge measurement errors
tend to result from the environment, which poses a tremendous risk
of health to those who have cardiovascular disease and require
their heart rates to be accurately monitored. Besides, while heart
rhythm irregularities may be accompanied by a pulse deficit,
directly identifying an irregular pulse as a heart rhythm
irregularity could be erroneous. It is therefore imperative to have
an algorithm that can preclude misjudgment of heart rhythm
irregularities. Moreover, there has never been a method or device
that not only can measure heart rate, but also can determine the
occurrence of sick sinus syndrome and detect such heart rhythm
irregularities as irregular pulse peaks, irregular heartbeat, and
atrial fibrillation.
BRIEF SUMMARY OF THE INVENTION
[0007] In order to solve the above problems, the primary objective
of the present invention is to provide a method for detecting heart
rhythm irregularities, comprising the steps of: a) measuring pulse
peaks continuously over a period of time to obtain a pulse peak
sequence and a pulse peak time interval sequence corresponding to
the pulse peak sequence; and b) calculating the absolute value of a
difference between a single pulse peak time interval in the pulse
peak time interval sequence and an average value of the pulse peak
time interval sequence, and determining that an irregular pulse
peak (IPP) has occurred if the absolute value is larger than or
equal to 15% to 25% of the average value of the pulse peak time
interval sequence.
[0008] In one preferred embodiment, the method for detecting heart
rhythm irregularities further comprises the step of: c) performing
the determination of the occurrence (or absence) of an irregular
pulse peak on each pulse peak time interval in the pulse peak time
interval sequence, calculating the ratio of the number of the
identified irregular pulse peaks to the total number of the time
intervals in the pulse peak time interval sequence, and determining
that irregular heartbeat (IHB) has occurred if the ratio is larger
than or equal to a threshold value.
[0009] In one preferred embodiment, the method for detecting heart
rhythm irregularities further comprises the steps of: d) pausing
for a period of time, then measuring pulse peaks continuously over
another period of time to obtain a second pulse peak sequence and a
second pulse peak time interval sequence corresponding to the
second pulse peak sequence, and performing the foregoing
determination of the occurrence (or absence) of irregular
heartbeat; e) pausing for a period of time, then measuring pulse
peaks continuously over another period of time to obtain a third
pulse peak sequence and a third pulse peak time interval sequence
corresponding to the third pulse peak sequence, and performing the
foregoing determination of the occurrence (or absence) of irregular
heartbeat; and f) determining that atrial fibrillation (AF) has
occurred if at least two occurrences of irregular heartbeat are
identified in the three consecutive performances of the
determination of the occurrence (or absence) of irregular
heartbeat.
[0010] In one preferred embodiment, the determination of the
occurrence of an irregular pulse peak includes grading an irregular
pulse peak according to the percentage of the average value of the
pulse peak time interval sequence that the absolute value is larger
than or equal to.
[0011] In one preferred embodiment, an irregular pulse peak is
graded as a 15% irregular pulse peak (IPP 15%) if the absolute
value is larger than or equal to 15% of the average value of the
pulse peak time interval sequence, as a 20% irregular pulse peak
(IPP 20%) if the absolute value is larger than or equal to 20% of
the average value of the pulse peak time interval sequence, or as a
25% irregular pulse peak (IPP 25%) if the absolute value is larger
than or equal to 25% of the average value of the pulse peak time
interval sequence.
[0012] In one preferred embodiment, the method for detecting heart
rhythm irregularities determines that sick sinus syndrome (SSS) has
occurred if a single pulse peak time interval in the pulse peak
time interval sequence is longer than or equal to 3 seconds or if
the pulse peak frequency of the pulse peak time interval sequence
is lower than or equal to 50 times per minute.
[0013] In one preferred embodiment, the detection is carried out
with a sphygmomanometer that measures blood pressure by the
oscillometric method.
[0014] Another objective of the present invention is to provide a
detection device, comprising: a detecting portion for measuring
pulse peaks continuously over a period of time; a recording portion
for receiving and recording measurement data obtained by the
detecting portion; a processor for performing computation on the
measurement data in the recording portion and for determining the
occurrence of heart rhythm irregularities by the foregoing method;
and a display device for displaying a determination result of the
processor.
[0015] In one preferred embodiment, the detection device is a
sphygmomanometer that measures blood pressure by the oscillometric
method or the auscultatory method, or a smartwatch that measures
blood pressure/heart rhythm through an inflatable bladder.
[0016] In one preferred embodiment, the detecting portion includes:
a bladder adapted to be wrapped around a user's limb at a position
corresponding to an artery; an air pressure pump for inflating the
bladder; at least one pressure sensor for measuring the pressure in
the bladder; a pressure relief valve through which air is
discharged from the bladder; and a microcontroller unit for
controlling the operation of the air pressure pump and the pressure
relief valve.
[0017] The present invention provides a method and device that use
a non-invasive approach to detecting heart rhythm irregularities.
In addition to monitoring a person's heart rate continuously, the
method and device disclosed herein can determine the occurrence of
such heart rhythm irregularities as sick sinus syndrome, irregular
pulse peaks, irregular heartbeat, and atrial fibrillation by means
of a special algorithm. The method and device of the invention can
be applied to a sphygmomanometer or a wearable device (e.g., a
smartwatch) in order to detect, for example, the radial artery in a
user's arm and measure the user's pulse and its rhythm, thereby
adding to the convenience of self-measurement. The invention is
advantageous in that it reduces errors associated with the use of a
photoplethysmographic detection device (e.g., errors resulting from
the way the detection device is worn or from the sweat on a user's
skin) and is suitable for personal or household daily health care.
A sphygmomanometer capable of detecting heart rhythm irregularities
as disclosed herein can be used in emergency rooms, intensive care
units, hospital wards, clinics, and other medical institutions and
therefore has high utility value in the medical industry.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0018] FIG. 1 shows the steps of the method for detecting heart
rhythm irregularities according to a preferred embodiment of the
present invention.
[0019] FIG. 2 is an assembled perspective view of the detection
device according to a preferred embodiment of the present
invention.
[0020] FIG. 3 is a side view of the detection device according to a
preferred embodiment of the present invention.
[0021] FIG. 4 is a perspective view of the bladder of the detection
device according to a preferred embodiment of the present
invention.
[0022] FIG. 5 shows the display screen diagrams (a) and (b) of the
detection device according to a preferred embodiment of the present
invention.
[0023] FIG. 6 shows the pulse signals of the method for detecting
heart rhythm irregularities according to a preferred embodiment of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The details and technical solution of the present invention
are hereunder described with reference to accompanying drawings.
For illustrative sake, the accompanying drawings are not drawn to
scale. The accompanying drawings and the scale thereof are not
restrictive of the present invention.
[0025] Throughout the whole document, the terms "comprises or
includes" and/or "comprising or including" used in the document
mean that one or more other components, steps, operations, and/or
the existence or addition of elements are not excluded in addition
to the described components, steps, operations and/or elements. The
terms "about or close to" or "substantially" mean a value or range
that is close to the allowable specified error to avoid any
unreasonable use by third parties, illegal or unfair use, to
understand the precise or absolute value disclosed herein. The
terms "a" and "an" refer to one or to more than one (i.e., to at
least one) of the grammatical object of the article.
[0026] Referring to FIG. 1, the present invention provides a method
for detecting heart rhythm irregularities, and the method includes
the steps of: a) measuring pulse peaks continuously over a period
of time to obtain a pulse peak sequence and a pulse peak time
interval sequence corresponding to the pulse peak sequence; and b)
calculating the absolute value of the difference between a single
pulse peak time interval in the pulse peak time interval sequence
and the average value of the pulse peak time interval sequence, and
determining that an irregular pulse peak (IPP) has occurred if the
absolute value is larger than or equal to 15% to 25% of the average
value of the pulse peak time interval sequence.
[0027] As used herein, the term "heart rhythm irregularity" refers
to an abnormal pulsation frequency or rhythm of the heart, an
abnormal origin of cardiac impulse, an abnormal conduction velocity
in the heart, an abnormal sequence of excitation of the heart, or
the like, whose clinical characteristics may include an exceedingly
fast, exceedingly slow, or irregular rhythm of the heart. In one
preferred embodiment, the present invention can identify heart
rhythm irregularities by detecting one or (in a separate manner) a
combination of heart rhythm irregularities selected from the group
consisting of irregular pulse peaks, irregular heartbeat, atrial
fibrillation, and sick sinus syndrome. In a more preferred
embodiment, the present invention can identify heart rhythm
irregularities by detecting irregular pulse peaks, irregular
heartbeat, atrial fibrillation, and sick sinus syndrome
simultaneously.
[0028] As used herein, the term "pulse peak" refers to a waveform
of the pulsation of an artery, or more particularly a curve
representing the rise and fall of the pressure in an artery when
blood flows therethrough during a cardiac cycle. Pulse peaks
reflect how an artery pulsates and serve as a means by which to
locate a lesion and identify the corresponding symptom.
[0029] As used herein, the term "irregular pulse peak" (IPP) refers
to a condition in which an irregular rhythm of the heart can be
inferred from pulse peaks measured continuously over a period of
time. In one embodiment of the present invention, the method for
detecting heart rhythm irregularities includes the steps of: a)
measuring pulse peaks continuously over a period of time to obtain
a pulse peak sequence and a pulse peak time interval sequence
corresponding to the pulse peak sequence; and b) calculating the
absolute value of the difference between a single pulse peak time
interval in the pulse peak time interval sequence and the average
value of the pulse peak time interval sequence, and determining
that an irregular pulse peak has occurred if the absolute value is
larger than or equal to 15% to 25% of the average value of the
pulse peak time interval sequence. In one preferred embodiment, the
determination of the occurrence of an irregular pulse peak further
includes grading an irregular pulse peak according to the
percentage of the average value of the pulse peak time interval
sequence that the absolute value is larger than or equal to,
wherein the percentage includes but is not limited to 5%, 10%, 15%,
20%, and 25%. In a more preferred embodiment, an irregular pulse
peak is graded as a 15% irregular pulse peak (IPP 15%) if the
absolute value is larger than or equal to 15% of the average value
of the pulse peak time interval sequence, as a 20% irregular pulse
peak (IPP 20%) if the absolute value is larger than or equal to 20%
of the average value of the pulse peak time interval sequence, or
as a 25% irregular pulse peak (IPP 25%) if the absolute value is
larger than or equal to 25% of the average value of the pulse peak
time interval sequence.
[0030] As used herein, the term "irregular heartbeat" (also known
as cardiac arrhythmia or cardiac dysrhythmia) refers to a condition
in which a heart rhythm irregularity exceeding a normal range
(i.e., exceeding a threshold value) can be inferred from pulse
peaks measured continuously over a period of time. In one
embodiment of the present invention, the method for detecting heart
rhythm irregularities includes the steps of: a) measuring pulse
peaks continuously over a period of time to obtain a pulse peak
sequence and a pulse peak time interval sequence corresponding to
the pulse peak sequence; b) calculating the absolute value of the
difference between a single pulse peak time interval in the pulse
peak time interval sequence and the average value of the pulse peak
time interval sequence, and determining that an irregular pulse
peak has occurred if the absolute value is larger than or equal to
15% to 25% of the average value of the pulse peak time interval
sequence; and c) performing the determination of the occurrence (or
absence) of an irregular pulse peak on each pulse peak time
interval in the pulse peak time interval sequence, calculating the
ratio of the number of the identified irregular pulse peaks to the
total number of the time intervals in the pulse peak time interval
sequence, and determining that irregular heartbeat has occurred if
the ratio is larger than or equal to a threshold value. The
threshold value may be 5%, 10%, 15%, 20%, 25%, 30%, 35%, or 40%;
the present invention has no limitation in this regard. In one
preferred embodiment, irregular heartbeat is determined to have
occurred if the ratio of the number of the identified irregular
pulse peaks to the total number of the time intervals in the pulse
peak time interval sequence is larger than or equal to 20%.
[0031] As used herein, the term "atrial fibrillation" refers to a
condition in which a heart rhythm irregularity exceeding a normal
range and having an increasing duration or frequency can be
inferred from pulse peaks measured continuously over a period of
time. Clinically, atrial fibrillation is the most common of all
heart rhythm irregularities. In one embodiment of the present
invention, the method for detecting heart rhythm irregularities
includes the steps of: a) measuring pulse peaks continuously over a
period of time to obtain a pulse peak sequence and a pulse peak
time interval sequence corresponding to the pulse peak sequence; b)
calculating the absolute value of the difference between a single
pulse peak time interval in the pulse peak time interval sequence
and the average value of the pulse peak time interval sequence, and
determining that an irregular pulse peak has occurred if the
absolute value is larger than or equal to 15% to 25% of the average
value of the pulse peak time interval sequence; c) performing the
determination of the occurrence (or absence) of an irregular pulse
peak on each pulse peak time interval in the pulse peak time
interval sequence, calculating the ratio of the number of the
identified irregular pulse peaks to the total number of the time
intervals in the pulse peak time interval sequence, and determining
that irregular heartbeat has occurred if the ratio is larger than
or equal to a threshold value; d) pausing for a period of time,
then measuring pulse peaks continuously over another period of time
to obtain a second pulse peak sequence and a second pulse peak time
interval sequence corresponding to the second pulse peak sequence,
and performing the foregoing determination of the occurrence (or
absence) of irregular heartbeat; e) pausing for a period of time,
then measuring pulse peaks continuously over another period of time
to obtain a third pulse peak sequence and a third pulse peak time
interval sequence corresponding to the third pulse peak sequence,
and performing the foregoing determination of the occurrence (or
absence) of irregular heartbeat; and f) determining that atrial
fibrillation has occurred if at least two occurrences of irregular
heartbeat are identified in the three consecutive performances of
the determination of the occurrence (or absence) of irregular
heartbeat. In another embodiment of the present invention, atrial
fibrillation is determined to have occurred if at least three
occurrences of irregular heartbeat are identified in five
consecutive performances of the determination of the occurrence (or
absence) of irregular heartbeat.
[0032] As used herein, the term "sick sinus syndrome" refers to a
condition in which there is at least one incidence of the heart
pausing for at least 3 seconds or the heart beats slower and slower
(typically with a heart rate/pulse rate lower than 40 to 50 times
per minute). Sick sinus syndrome may have such symptoms as
dizziness and physical weakness. In one embodiment of the present
invention, the method for detecting heart rhythm irregularities
determines that sick sinus syndrome has occurred if a single pulse
peak time interval in the pulse peak time interval sequence is
longer than or equal to 3 seconds or if the pulse peak frequency
(also known as pulse frequency) of the pulse peak time interval
sequence is lower than or equal to 50 times per minute.
[0033] As used herein, the term "period of time" refers to either a
time span of continuous measurement or an intermission, the former
of which may be 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25
seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, and so on
without limitation, and the latter of which may be 5 seconds, 10
seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, and so on
without limitation. In one preferred embodiment of the present
invention, the method for detecting heart rhythm irregularities
uses a 25-second time span of continuous measurement and a
10-second intermission.
[0034] As used herein, the term "intermission" refers to a period
of time over which measurement and/or recording and/or computation
(the present invention has no limitation in this regard) is
temporarily stopped.
[0035] The present invention also provides a detection device that
includes: a detecting portion for measuring pulse peaks
continuously over a period of time; a recording portion for
receiving and recording the measurement data obtained by the
detecting portion; a processor for performing computation on the
measurement data in the recording portion and for determining the
occurrence (or absence) of heart rhythm irregularities by the
foregoing method for detecting heart rhythm irregularities; and a
display device for displaying the determination result of the
processor.
[0036] As used herein, the term "detection device" refers to a
device for determining the occurrence (or absence) of heart rhythm
irregularities by the foregoing method for detecting heart rhythm
irregularities, and the device may be a sphygmomanometer, a smart
bracelet, a smartwatch, or the like, without limitation. In one
preferred embodiment of the present invention, the detection device
is a sphygmomanometer that measures blood pressure by the
oscillometric method or the auscultatory method. In another
preferred embodiment of the present invention, the detection device
is a smartwatch that measures blood pressure/heart rhythm through
an inflatable bladder (see FIG. 3).
[0037] As used herein, the term "detecting portion" refers to the
portion of the detection device that is configured to measure pulse
peaks continuously over a period of time, and the detecting portion
may use either the resonance method or the low-pressure method as
its detection method, without limitation. In one preferred
embodiment, the detecting portion includes: a bladder adapted to be
wrapped around a user's limb at a position corresponding to an
artery, wherein the artery may be, but is not limited to, a
brachial artery or a radial artery; an air pressure pump for
inflating the bladder so that, once inflated, the bladder occludes
the artery temporarily; at least one pressure sensor for measuring
the pressure in the bladder; a pressure relief valve through which
air is discharged from the bladder; and a microcontroller unit for
controlling the operation of the air pressure pump and the pressure
relief valve. In one preferred embodiment, the detecting portion
detects pressure variation by the oscillometric method or the
auscultatory method in order to obtain pulse signals.
[0038] As used herein, the term "recording portion" refers to the
portion of the detection device that is configured to receive and
record the measurement data obtained by the detecting portion,
wherein the measurement data at least includes data or graphs that
show the correspondence between pulse peaks and time (or time
points), among other information. The recording portion may be any
stationary or movable random access memory (RAM), read-only memory
(ROM), flash memory, other similar devices, or a combination of the
above.
[0039] As used herein, the term "processor" refers to the portion
of the detection device that is configured to perform computation
on the measurement data in the recording portion and to determine
the occurrence (or absence) of heart rhythm irregularities by the
foregoing method for detecting heart rhythm irregularities. More
specifically, the processor may be coupled to the recording
portion, where the measurement data is stored, in order to perform
the predetermined steps by accessing the program(s) or data in the
recording portion. The processor may be a central processing unit
(CPU), a programmable general-purpose or special-purpose
microprocessor, a digital signal processor (DSP), a programmable
controller, an application-specific integrated circuit (ASIC), a
programmable logic device (PLD), other similar devices, or a
combination of the above. In another preferred embodiment, the
processor and the recording portion form a co-constructed processor
for loading the prestored program(s) in the recording portion and
executing the corresponding commands and algorithms.
[0040] As used herein, the term "display device" refers to the
portion of the detection device that is configured to display the
determination result of the processor. For example, in cases where
the detection device of the present invention is implemented as a
desktop device, such as a sphygmomanometer, the display device may
be an externally connected display screen, and in cases where the
detection device of the present invention is implemented as a
wearable device, such as a smartwatch, the display device may be
the screen of the smartwatch (see FIG. 5); the present invention
has no limitation in this regard.
[0041] The detection device of the present invention may be further
connected to a communication module for transmitting the
determination result or the recorded data to an external device or
for enabling remote control. The communication module may
communicate with a remote processor or other device in a wired or
wireless manner. Wired communication can be carried out, for
example, via a physical transmission interface configured for
electrical or optical signal transmission, and wireless
communication, via one or a combination of at least two of the
following protocols/techniques: Bluetooth, infrared (IR)
transmission, near-field communication (NFC), ultra-wideband (UWB),
wireless local area networks (WLAN), Wireless Gigabit Alliance
(WiGig Alliance) communications technology, ZigBee, wireless
universal serial bus (wireless USB), and Wi-Fi. The present
invention has no limitation on the type of the communication module
or the communication protocol or encryption method used
thereby.
[0042] The present invention will be described in more detail below
with reference to some illustrative embodiments. It should be
understood, however, that the embodiments serve only to facilitate
understanding, but not to restrict the scope, of the invention.
[0043] I. Embodiment 1--Determining the Occurrence (Absence) of an
Irregular Pulse Peak
[0044] Referring to steps a and b in FIG. 1, the method of the
present invention for detecting heart rhythm irregularities can be
used to detect an irregular pulse peak, and the determination steps
are as follows:
[0045] [Step a]:
[0046] Pulse peaks are measured continuously for 25 seconds to
obtain a pulse peak sequence and a pulse peak time interval
sequence P.sub.(i) corresponding to the pulse peak sequence, where
i is an integer ranging from 1 to N.
[0047] Referring to the pulse signal graph in FIG. 6, pulse signals
are detected while the bladder is gradually pressurized (i.e.,
inflated). Pulse peaks are measured continuously for 25 seconds
such that a pulse peak sequence and a pulse peak time interval
sequence P.sub.(i) corresponding to the pulse peak sequence are
obtained, where i is an integer ranging from 1 to 15. During the
25-second period, the first pulse peak detected (indicated by the
letter a in FIG. 6) and the second pulse peak detected (indicated
by the letter b in FIG. 6) are spaced apart by the first time
interval (indicated by the notation P.sub.(i) in FIG. 6).
[0048] [Step b]:
[0049] The average value M of the pulse peak time interval sequence
P.sub.(i) is calculated, and then the absolute value of the
difference between a single pulse peak time interval and the
average value M is calculated. If the absolute value is larger than
or equal to any value between 15% and 25% of the average value M
inclusive, it is determined that an irregular pulse peak (IPP) has
occurred. Mathematically, the determination of the occurrence of
IPP can be expressed by the following inequality: [0050] IPP:
|P.sub.(i)-M|.gtoreq.M.times.(15%-25%), where i is an integer
ranging from 1 to N.
[0051] [Step b-1]: Determining the Degree of Irregularity of the
Irregular Pulse Peak Identified
[0052] In embodiment 1, the irregularity of the irregular pulse
peak identified can be graded as follows according to the
percentage of the average value M of the pulse peak time interval
sequence that the absolute value is larger than or equal to: [0053]
IPP 15%: |P.sub.(i)-M|.gtoreq.M.times.15%, where i is an integer
ranging from 1 to N; [0054] IPP 20%:
|P.sub.(i)-M|.gtoreq.M.times.20%, where i is an integer ranging
from 1 to N; or [0055] IPP 25%: |P.sub.(i)-M|.gtoreq.M.times.25%,
where i is an integer ranging from 1 to N.
[0056] [Repeated Detection Mode]
[0057] The determination of the occurrence (or absence) of an
irregular pulse peak can be performed repeatedly and consecutively
for a plurality of times, e.g., three times as detailed below.
Pulse peaks are measured continuously over the first 25-second time
span of continuous measurement, and the first set of IPP-related
computation is carried out accordingly. Then, measurement is
stopped for a 10-second intermission, before the second 25-second
time span of continuous measurement begins and gives rise to the
second set of IPP-related computation. After that, measurement is
stopped for another 10-second intermission, before the third
25-second time span of continuous measurement begins and gives rise
to the third set of IPP-related computation. Thus, three IPP
determination results are obtained to avoid errors attributable to
a single measurement.
[0058] The present invention has no limitation on the number of
times for which detection should be repeated, the time span of
continuous measurement, or the duration of the intermission.
[0059] II. Embodiment 2-Determining the Occurrence (or Absence) of
Irregular Heartbeat
[0060] Referring to step c in FIG. 1, the method of the present
invention for detecting heart rhythm irregularities can be used to
detect irregular heartbeat, and the determination step is as
follows:
[0061] [Step c]:
[0062] Following step b, IPP determination is performed on each
pulse peak time interval in the pulse peak time interval sequence
P.sub.(i), i.e., on the first through the N.sup.th pulse peak time
intervals. The number B of the irregular pulse peaks identified in
the sequence P.sub.(i) is counted. Then, the ratio of the number B
of the identified irregular pulse peaks to the total number N of
the time intervals in the sequence P.sub.(i) is calculated. If the
ratio is larger than or equal to a threshold value, it is
determined that irregular heartbeat (IHB) has occurred. The
threshold value in this embodiment is 20%, but the present
invention has no limitation on this value. Mathematically, the
determination of the occurrence of IHB can be expressed by the
following inequality:
IHB : B N .gtoreq. 20 % . ##EQU00001##
[0063] [Repeated Detection Mode]
[0064] The determination of the occurrence (or absence) of
irregular heartbeat can be performed repeatedly and consecutively
for a plurality of times, e.g., three times as detailed below.
Pulse peaks are measured continuously over the first 25-second time
span of continuous measurement, and the first set of IHB-related
computation is carried out accordingly. Then, measurement is
stopped for a 10-second intermission, before the second 25-second
time span of continuous measurement begins and gives rise to the
second set of IHB-related computation. After that, measurement is
stopped for another 10-second intermission, before the third
25-second time span of continuous measurement begins and gives rise
to the third set of IHB-related computation. Thus, three IHB
determination results (i.e., the IHB determination results 1, 2,
and 3 in FIG. 1) are obtained to avoid errors attributable to a
single measurement.
[0065] The present invention has no limitation on the number of
times for which detection should be repeated, the time span of
continuous measurement, or the duration of the intermission.
[0066] III. Embodiment 3-Determining the Occurrence (or Absence) of
Atrial Fibrillation
[0067] Referring to steps d to f in FIG. 1, the method of the
present invention for detecting heart rhythm irregularities can be
used to detect atrial fibrillation, and the determination steps are
as follows:
[0068] [Step d]:
[0069] After step c (i.e., after determining the occurrence or
absence of IHB in the sequence P.sub.(i)), measurement is stopped
for 10 seconds. Then, pulse peaks are measured continuously for 25
seconds to obtain another pulse peak sequence and a pulse peak time
interval sequence Q.sub.(i) corresponding to this pulse peak
sequence, where i is an integer ranging from 1 to N. The occurrence
(or absence) of IHB in the sequence Q.sub.(i) is determined as in
step c.
[0070] [Step e]:
[0071] Measurement is stopped for 10 seconds, and then pulse peaks
are measured continuously for 25 seconds to obtain yet another
pulse peak sequence and a pulse peak time interval sequence
R.sub.(i) corresponding to this pulse peak sequence, where i is an
integer ranging from 1 to N. The occurrence (or absence) of IHB in
the sequence R.sub.(i) is determined as in step c.
[0072] [Step f]:
[0073] If at least two occurrences of irregular heartbeat are found
in steps c to e (i.e., if IHB is determined to have occurred in at
least two of the sequences P.sub.(i), Q.sub.(i), and R.sub.(i)), it
is determined that atrial fibrillation (AF) has occurred.
[0074] IV. Embodiment 4-Determining the Occurrence (or Absence) of
Sick Sinus Syndrome
[0075] The method of the present invention for detecting heart
rhythm irregularities can also be used to derive the pulse
frequency or the pulsation frequency of the heart (i.e., heart
rate) from pulse peaks measured continuously over a period of
time.
[0076] [Step g]:
[0077] Referring to step g in FIG. 1, sick sinus syndrome is
determined to have occurred if a single pulse peak time interval in
the pulse peak time interval sequence is longer than or equal to 3
seconds or if the detected pulse peak frequency of the pulse peak
time interval sequence (i.e., the pulse frequency or heart rate) is
lower than or equal to 50 times per minute.
[0078] The method of the present invention for detecting heart
rhythm irregularities can be applied to and implemented by means of
a detection device. Two preferred embodiments of such a detection
device are disclosed below. The detection device of the present
invention can be used in emergency rooms, intensive care units,
hospital wards, and clinics, or as a personal or household daily
health care device, to monitor a patient's or user's heart rhythm
in real time.
[0079] V. Embodiment 5-Detection Device in the Form of a
Smartwatch
[0080] Referring to FIG. 2 to FIG. 5, this embodiment discloses a
smartwatch that doubles as a detection device 1 for implementing a
method for detecting heart rhythm irregularities as disclosed in
the foregoing embodiments 1 to 4.
[0081] The detection device 1 includes a detecting portion (not
shown), a recording portion (not shown), a processor (not shown),
and a display device 11. The detecting portion includes an
inflatable bladder 12 as shown in FIG. 4), an air pressure pump 13,
a pressure sensor 122, a pressure relief valve (not shown), and a
microcontroller unit (not shown). The microcontroller unit is
configured to control the operation of the motor in the air
pressure pump 13 and of the pressure relief valve so that the
bladder 12 can be inflated and deflated by the air pressure pump 13
through the air inlet 121 of the bladder 12. In this embodiment,
the pressure sensor 122 is provided on the bladder 12.
[0082] The detection device 1 can be worn on a user's wrist, with
the bladder 12 wrapped around the wrist, preferably with the
bladder 12 lying compliantly on the inner side of the wrist (see
FIG. 4) to provide higher sensitivity in measuring pressure
variation in the radial artery.
[0083] The user may choose between an ambulatory monitoring mode,
in which monitoring is carried out constantly, and a
measure-as-you-need mode, in which monitoring begins as soon as the
mode is chosen. FIG. 6 shows the pressure of the bladder 12 and the
pulse signals detected by the detection device 1 (using the
oscillometric method), both plotted against time. The graph in FIG.
6 shows how pulse peaks vary while the bladder is being slowly
pressurized. When the detection device 1 starts monitoring, the
detecting portion is gradually inflated (pressurized) to a fixed
pressure such as 175 mmHg (or the value 500 in FIG. 6). Once the
pressure is stable enough for the detection of pressure wave
variation, the varying pressure pulse peaks are measured
continuously over a predetermined period of time (e.g., 25
seconds).
[0084] That is to say, referring back to FIG. 1, the detection
device 1 performs step a in embodiment 1, followed by step b, which
determines whether an irregular pulse peak has occurred. If it is
determined that an irregular pulse peak has occurred, step b-1 is
performed to determine the degree of irregularity of the irregular
pulse peak (e.g., IPP 15%, IPP 20%, or IPP 25%). The determination
results of steps b and b-1 are displayed on the display device 11
(see FIG. 5(a)).
[0085] Then, with continued reference to FIG. 1, the detection
device 1 performs: step c in embodiment 2 regardless of the results
of steps b and b-1 in order to determine whether irregular
heartbeat (IHB) has occurred; steps d to fin embodiment 3
regardless of the results of steps b, b-1, and c in order to
determine whether atrial fibrillation (AF) has occurred; and step g
in embodiment 4 regardless of results of steps b to f and b-1 in
order to determine whether sick sinus syndrome has occurred. The
determination results of steps c to g are displayed on the display
device 11(see FIG. 5(b)).
[0086] When all the measurements are completed, the microcontroller
unit opens the pressure relief valve to deflate the bladder 12. The
inflation speed and deflation speed of the bladder 12 are
controlled by the microcontroller unit.
[0087] According to the above, the method and device of the present
invention for detecting heart rhythm irregularities can be used to
detect irregular pulse peaks (IPP), irregular heartbeat (IHB),
atrial fibrillation (AF), and sick sinus syndrome (SSS). Moreover,
the method of the present invention can be applied to a
sphygmomanometer that measures blood pressure by the oscillometric
method or the auscultatory method, or a wearable device (e.g., a
smartwatch) that measures blood pressure through an inflatable
bladder, making it easier for one to measure their own blood
pressure and thereby prevent medical conditions that may accompany
heart rhythm irregularities, such as myocardial infarction (heart
attack), hypertension, and angina. The present invention can be
used in emergency rooms, intensive care units, hospital wards, and
clinics or as a personal or household daily health care device and
therefore has high utility value in the medical industry.
[0088] The above is the detailed description of the present
invention. However, the above is merely the preferred embodiment of
the present invention and cannot be the limitation to the implement
scope of the present invention, which means the variation and
modification according to the present invention may still fall into
the scope of the invention.
* * * * *