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DESCRIPTION JP2017538454

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DESCRIPTION JP2017538454
Abstract: An ultra low frequency stethoscope for monitoring a physiological process of a patient
comprises a microphone capable of detecting an acoustic signal in an audio frequency band and
an ultra low frequency band (0.03 to 1000 Hz), and a microphone It includes a body coupler
attached to the body at the opening, a flexible tube attached to the body at the second opening of
the microphone, and an earpiece attached to the flexible tube. The body coupler can be attached
to the patient and sends human sound to the microphone and to the earpiece.
Infra-red stethoscope for monitoring physiological processes
[0001]
Cross-Reference to Related Applications This application claims the benefit of and priority to US
Provisional Patent Application No. 62 / 058,794 filed Oct. 2, 2014, US Non-Provisional Patent
Application No. 14 filed Mar. 16, 2015. No./658,584, the contents of which are incorporated
herein by reference in their entirety.
[0002]
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT The
invention described herein is made in the performance of the work of employees of the United
States government under a NASA contract, and the provisions of public law 96-517 (35 USC 202
202) apply. It may be manufactured and used by or for the government without payment of a
royalty on or for it.
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In accordance with 35 USC 202 202, the selected contractor does not retain the right.
[0003]
TECHNICAL FIELD The present disclosure relates to an infrasonic stethoscope “infrasonic
stethoscope” (or infrascope “infrascope”) for monitoring physiological processes, and more
particularly to a wireless infrasound stethoscope.
[0004]
Sounds with frequencies lower than 20 Hertz are termed "ultra-sound" infrasound ".
A particularly useful property of ultra bass is that it propagates over long distances with little
attenuation. Such characteristics of infrasound are such that atmospheric absorption is
substantially negligible at infrasound frequencies, and there is an acoustic "ceiling" in the
stratosphere where the positive slope of the speed of sound with respect to altitude is It is
because the reflection of low frequency rays to the earth is generated. Long-distance ultra-low
frequency propagation (eg, several thousand kilometers) is mainly due to refraction from the
upper layers of the atmosphere, while short-range propagation is by direct path.
[0005]
The density, acoustic impedance and speed of sound through different human and animal tissues
vary depending on the location of the auscultation. As the acoustic signal travels through the
tissue layer, the amplitude of the original signal becomes more attenuated than the depth of the
acoustic signal source. The attenuation (i.e. energy loss) may be due to absorption, reflection and
scattering at the interface of different tissues. Also, the degree of attenuation depends on the
frequency of the sound wave and the distance it travels. Generally speaking, high frequency
acoustic signals are associated with high attenuation, so penetration of tissue is also limited, but
low frequencies do not have the problem of attenuation, thus providing the physician with a
better understanding of the function of the heart. Power spectral densities above 60% of the
heart signal correspond to very low frequency bandwidth. Low frequency acoustic signals
detected from different human organs, such as the heart, are valuable to the physician for
monitoring the heart and lungs.
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[0006]
Microphones and stethoscopes are regularly used by physicians in detecting sound to monitor
physiological conditions. Phytocardiography has been used for over 75 years to detect the
audible sound of blood flowing through the heart as well as monitoring the heart rate. Monitors
of these physiological conditions are directly coupled to the human body and processes are
measured either by listening to or recording signals of a specific bandwidth. Physiological
processes such as respiration and cardiac activity are reflected in different frequency bandwidths
from 1/10 Hertz to 500 Hertz. Other stethoscopes can monitor only the audio frequency
bandwidth and can not monitor very low frequencies below 20 Hz. Low frequency acoustic
signals below 20 Hertz are not audible but can provide useful information to the physician.
[0007]
Inside a normal heart, there are four chambers: right atrium, left atrium, right ventricle, and left
ventricle. The function of the heart is to maintain blood flowing in one direction. When the valve
opens, the valve can bring the appropriate amount of blood through and then close to maintain
blood backflow during the heartbeat. An easy and relatively inexpensive assessment of the
patient's cardiac condition can be determined by the sound of the chest. The key to good
auscultation is in highs and lows. When the heart recoils, blood flows from the right atrium
through the tricuspid valve into the right ventricle.
[0008]
The blood is then referred to as a pulmonary valve (sometimes called a semi-lunar valve) to take
up the appropriate amount of oxygen. Through the lungs. Blood returns from the lungs to the left
atrium and through the mitral valve into the left ventricle. Blood is then pumped into the aorta
through the aortic valve, exits the other parts of the body, and provides oxygen and nutrients to
the body cells. All four chambers (right atrium, right ventricle, left atrium, and left ventricle) must
contract at just the right time for a normal heart to function properly. The proper timing is
regulated by the electrical path of the heart. Electrical signals are generated by the sinus node
(SA node) and the atrioventricular node (AV node).
[0009]
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The SA node located in the right atrium is a group of cells that initiates contraction of both atria
to push blood into the corresponding ventricle. Because of the insulation between the atria and
ventricles, the SA node signal does not continue directly to the ventricles, but passes through the
AV node, which is another group of cells located in the bed of the right atrium between the atria
and the ventricles. The AV node conditions the signal to ensure that the atrium is empty and
closed before the ventricles contract to push blood out of the heart. The SA node transmits a
signal to stimulate the heart to beat between 60 and 100 beats per minute.
[0010]
The cardiovascular system is complex and problems can arise anywhere from the heart's
electrical system to large and small blood vessels. There are more than 60 different types of
cardiovascular disease, all of which affect the heart or vascular system in part. Heart sounds are
generated by the beating of the heart and the resulting blood flow can provide important
information about the condition of the heart. In healthy adults, two normal heart sounds follow
the heart beat. The first sound is generated based on the closure of the atrioventricular valve (ie,
the mitral valve and the tricuspid valve) located between the atria and the ventricles and is
referred to as S1. The second sound is produced as a result of the closure of the semi-lunar
valves (i.e., the pulmonary and aortic valves), which control blood flow when leaving the heart via
the artery, and is referred to as S2.
[0011]
The first heart sound S1 is composed of four consecutive components. The first is a small low
frequency oscillation that occurs simultaneously with the onset of left ventricular contraction,
and the second is a readily audible high frequency oscillation associated with mitral valve closure
(M1), and thirdly the tricuspid valve closure. It is a related second high frequency component,
and fourth is a small frequency oscillation that occurs simultaneously with the acceleration of
blood to the large blood vessels.
[0012]
In addition to these normal sounds, various other types of sounds may also be present, but to
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pick up these sounds we need sensitive microphones and filters with lowest acoustic background
noise levels. The third low frequency sound may be heard at the beginning of the diastole and is
referred to as S3. The fourth sound may be heard in late diastole during atrial contraction and is
referred to as S4. These sounds can be associated with heart noise, indeterminate sounds,
ventricular gallops and gallop prisms. S4 provides information about hypertension and acute
myocardial infarction.
[0013]
Heart sounds S1, S2, S3 and S4 can be attributed to specific cardiac activity. S1 is due to the
onset of ventricular contraction (band 10 to 140 hertz). S2 is due to the occlusion of the semilunar valve (band 10 to 400 Hz). S3 may be due to ventricular gallop, which may be heard during
rapid filling of the ventricle (ie, diastole). S4 may be due to atrial gallop, which may be heard
during late atrial contraction, during atrial contraction. S3 and S4 have very low intensity and
can be heard from the outside when amplified.
[0014]
Other sounds may be the opening of the mitral valve or the ejection of blood into the aorta,
which indicate valve dysfunction such as stenosis or regurgitation. Other high frequency noise
can occur between the two major heart sounds during systole or diastole. The noise can not be
harmless and can also indicate certain cardiovascular defects.
[0015]
Continuous fetal heart rate monitoring is an important step to assess fetal health. Fetal heart rate
may indicate if the fetus is getting enough oxygen. In most cases, ultrasound transducers are
used for fetal heart rate because it is not desirable for a conventional stethoscope to pick up the
signal from the maternal abdominal cavity. Depending on the fat of the mother's abdomen or the
position of the fetus, it may be difficult to passively monitor the heart of the fetus and in most
cases an ultrasound transducer is used and ultrasound pulses are emitted towards the fetus,
Reflected pulses are used for monitoring. If not enough reflected signal is received, the
penetration depth of the ultrasonic pulse will increase, which may reduce the quality and the
signal to noise ratio. High frequency ultrasound signals become attenuated due to absorption,
reflection and scattering by abdominal fat. Very low frequency signals have relatively very low
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attenuation coefficients, so the signals are of high quality with better signal to noise ratio and are
expected to be useful to gynecologists.
[0016]
Many heart sounds are in the low frequency band at low intensity levels and may require very
sensitive ultra low frequency microphones to obtain useful information that can not be perceived
by the physician's ear. Passive filters may be useful for recording low and high frequency bands
separately. Sound is of short duration and highly non-stationary, but makes it possible to
measure systolic and diastolic time intervals, which are important for diagnosis.
[0017]
Thus, there is a need for a monitoring device that overcomes the disadvantages presented by the
prior art.
[0018]
The monitoring of the infrasound stethoscope (or infrascope) or the physiological process of the
patient includes a microphone capable of detecting audio signals in the audio frequency band
and the infrasound band.
The microphone has a body, which includes first and second spaced openings. The body coupler
is attached to the first opening of the body to form a substantially air tight seal, and the body
coupler can be attached to the patient to monitor the physiological process. The flexible tube is
attached to the body at the second opening of the microphone. The earpiece is attached to the
flexible tube. The body coupler can be attached to the patient to send sound from the patient to
the microphone and then to the earphones.
[0019]
These and other features, benefits and objects of the present invention will be understood and
appreciated by those skilled in the art by further reference to the following specification, claims
and appended drawings.
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[0020]
The structure and method of the structure and operation of the disclosed embodiments, as well
as their additional objects and advantages, may be best understood by reference to the following
description and by reference to the accompanying drawings in which: However, it is not
necessarily drawn to scale and like reference numerals refer to like components.
[0021]
FIG. 1 is a perspective view of an embodiment of an infrascope that can be used for external
monitoring of a patient.
FIG. 2 is a perspective view of an infrascope attached to a catheter and used to monitor the fetus
inside a patient.
FIG. 3 is a perspective view of a pair of infrascopes, which can be used for Doppler
echocardiography. FIG. 4 is a graph showing the bandwidth of heart sounds. FIG. 5 is a crosssectional view of a microphone and a microphone forming part of the infrascope of the present
invention, according to a first embodiment, and a body coupler forming part of the infrascope of
the present disclosure. FIG. 5A is a cross-sectional view of a main body coupler according to a
second embodiment, which forms a part of the infrascope of the present disclosure. FIG. 6 is a
schematic view of a patient's skeleton. FIG. 7 is a flow chart of the process of how signals from
the infrascope are transmitted and analyzed. FIG. 8 is a chart of infrascope signals collected with
reference to the electrocardiogram signal referred to as ECG or EKG at position A of FIG. FIG. 9 is
a chart of an infrascope signal collected with reference to an electrocardiogram signal referred to
as ECG or EKG at position A of FIG. FIG. 10 is a chart of the infrascope signal collected with
reference to the signal of the electrocardiogram referred to as ECG or EKG at position P of FIG.
FIG. 11 is a chart of the infrascope signal collected with reference to the electrocardiogram signal
referred to as ECG or EKG at position P in FIG. FIG. 12 is a chart of the infrascope signal collected
with reference to the electrocardiogram signal referred to as ECG or EKG at position T of FIG. FIG.
13 is a chart of an infrascope signal collected with reference to an electrocardiogram signal
referred to as an ECG or EKG at position T in FIG. FIG. 14 is a chart of the infrascope signal
collected with reference to the electrocardiogram signal referred to as ECG or EKG at position M
in FIG. FIG. 15 is a chart of infrascope signals collected with reference to the electrocardiogram
signal referred to as ECG or EKG at position M of FIG. FIG. 16 is a chart of infrascope signals
collected with reference to the electrocardiogram signal referred to as ECG or EKG at position T
in FIG. FIG. 17 is a chart of the infrascope signal collected with reference to the
electrocardiogram signal referred to as ECG or EKG at position T in FIG. FIG. 18 shows a chart of
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infrascope data compared to ECG or EKG for a first subject from 1 Hz to 1000 Hz. FIG. 19 shows
a chart of infrascope data compared to ECG or EKG for a second subject from 1 Hz to 1000 Hz.
[0022]
While the disclosure is capable of embodiments in different forms, it is shown in the drawings
and described in detail herein, and the specific embodiments illustrate, illustrate and describe the
principles of the disclosure. It is understood that it is not intended to limit the disclosure. Thus,
unless otherwise stated, the features disclosed herein may be combined together to form
additional combinations not shown for the sake of brevity. It will also be appreciated that, in
some embodiments, one or more components illustrated by way of example in the drawings may
be removed and / or replaced with other components within the scope of the present disclosure.
[0023]
As shown in FIG. 1, infrascope 20 is provided to monitor the physiological processes of the
patient. Infrascope 20 detects signals with bandwidths from 0.03 Hz to 1000 Hz, or alternatively
from 0.03 Hz to 500 Hz. These bandwidths include audible and inaudible signals to the human
ear. Infrascope 20 measures various human rephysical processes including, but not limited to,
cardiac monitoring, external fetal monitoring, internal fetal monitoring, stress echocardiography
testing, Doppler echocardiography, biometrics and polygraphs It has multiple uses. The
bandwidth of the audible and inaudible sounds generated by cardiac activity is shown in FIG. 4,
which shows the energy distribution (dynes / cm <2>) as a function of frequency (Hz).
[0024]
The infrascope 20 includes a microphone 22, a body coupler 24 or 24 a attached to the
microphone 22, a flexible tube 26 attached to the microphone 22, and an earpiece 28 attached
to the flexible tube 26. For internal fetal monitoring, as shown in FIG. 2 and described further
herein, a body coupler 24a is used and a microphone 22 is connected to the catheter 23 via the
body coupler 24a.
[0025]
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The microphone 22 is substantially the same as the microphone described in US Pat. No.
8,401,217, and the correction points are described herein. The contents of US Pat. No. 8,401,217
are incorporated in their entirety by reference.
[0026]
The microphone 22 is best seen in FIG. 5 and includes a cup-shaped body 30, a cup-shaped
support plate 32, an insulator 34, a conductor 36, a back plate 38, a membrane 40, and a low
noise preamplifier substrate 42.
[0027]
The body 30 has a cylindrical side wall 44 having a proximal end and a distal end, an end wall 46
at the proximal end of the body 30, and a connection port 48 extending proximally from the end
wall 46.
The main body 30 is formed of a metal such as stainless steel or aluminum. Side wall 44 and end
wall 46 define an internal cavity 50 within body 30. The distal end of the body 30 is open such
that an opening 52 is defined in the body 30. A thread form 54 is provided on the outer surface
of the side wall 44 at the distal end. The end wall 46 may substantially close the proximal end of
the body 30 and extend perpendicular to the sidewall 44, except for the opening 56
therethrough. Opening 56 may be centrally located in end wall 46 and is in communication with
connection port 48. The connection port 48 extends proximally from the end wall 46 and has a
passageway 58 therethrough, which communicates with the cavity 50 through the opening 56.
The outer surface of the connection port 48 has a thread form 60 thereon. An opening 62 is
provided through sidewall 44 at a location spaced from the proximal end of sidewall 44.
[0028]
The support plate 32 is attached to the inner surface of the side wall 44 and mounted within the
cavity 50. The support plate 32 is formed of metal and has a circular bottom wall 64 extending
the diameter of the side wall 44 and parallel to the end wall 46 and, accordingly, the side wall 6
extending distally from the bottom wall 64. Sidewall 66 ends at the free end. Side wall 66
engages the inner surface of side wall 44 of body 30 such that the free end of side wall 66 is
close to the distal end of body 30 and bottom wall 64 is spaced from the distal end of body 30 .
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The support plate 32 is secured to the body 30 by suitable means such as welding so that the
entire assembly can be connected to the ground of the preamplifier substrate 42. As a result of
such a configuration, a distal chamber 68 is formed between the bottom wall 64 and the distal
end of the body 30, and a proximal chamber 70 is formed between the bottom wall 64 and the
proximal end of the body 30. The bottom wall 64 has an opening 72 therethrough which may be
centrally located. Bottom wall 64 also has at least one opening 74 or slot therethrough for air to
flow from distal chamber 68 to proximal chamber 70.
[0029]
Insulating member 34 may be formed from plastic, ceramic, wood or any suitable insulating
material and is mounted within opening 72 of support plate 32 and from support plate 32 to
conductor 36, back plate 38 and preamplifier substrate 42. It is used for electrical isolation. As
shown, the insulating member 34 includes a central portion 76 extending from the opening 72, a
proximal portion 78 extending radially outward from the central portion 76 distal to the bottom
wall 64, and a proximal portion of the bottom wall 64. It has a distal portion 80 which extends
radially outward from the central portion 76 on the side. The passage 82 extends through the
central portion 76.
[0030]
The back plate 38 may be formed of a conductive material, may be formed from the bottom wall
88, and may further be formed from a proximal extension 90 extending perpendicularly from the
bottom wall 88. The back plate 38 may be formed of, for example, conductive ceramics, brass, or
stainless steel. The passage 89 extends through the bottom wall 88 from its proximal surface to
its distal surface, and also through the extension 90, if provided. A permanently polarized thin
polymer film 91 is coated on the distal surface of the backplate 38. The polarized thin polymer
film 91 operates without the need for an external power supply. As described in US Pat. No.
8,401,217, the backplate 38 has a plurality of spaced holes 92 therethrough (two holes can be
seen in FIG. 5). Extension 90 engages distal portion 80 of insulating member 34 and is secured to
the distal end of conductor 36 such that back plate 38 and conductor 36 are in electrical
communication. The bottom wall 88 of the back plate 38 is parallel to the bottom wall 64 of the
support plate 32. The slot 94 is defined between the outer diameter of the backplate 38 and the
side wall 44 of the body 30. The area between the backplate 38 and the proximal end of the
body 30 defines a posterior chamber.
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[0031]
Conductors 36 extend through passages 82, 89 and extend into proximal chamber 70. The
conductor 36 is electrically connected to the back plate 38. As shown, the conductor 36 is
formed of a conductive rod or wire 84, which extends through the passages 82, 89 and the
conductive rod 86 is proximal from the conductive rod or wire 84 and the insulating member 34.
It extends to When formed from two components, the components are interconnected to form an
appropriate electrical connection with one another. Rod or wire 84 and rod 86 may be formed of
brass or may be formed of different conductive materials. The proximal ends of the conductors
36 are close but spaced apart to the end wall 46 such that a gap is defined therebetween.
[0032]
The membrane 40 is formed of a flexible conductive material and attached to the distal free end
of the side wall 66 of the support plate 32 and the membrane 40 is disposed within the distal
chamber 68 and proximate to the distal end of the body 30 Are spaced apart. The diameter of the
membrane 40 is chosen such that the membrane 40 remains in the side wall 66. The membrane
40 is parallel to the end wall 46 of the body 30 and the bottom wall 64 of the support plate 32.
As a result, the membrane 40 is in electrical communication with the support plate 32. The
tension of the membrane 40 may be less than about 400 Newtons per meter.
[0033]
The backplate 38 is close to, but spaced from, the membrane 40 and an air gap between the
membrane 40 and the backplate 38 to create a capacitor for the microphone 22 as described in
US Pat. No. 8,401,217. 98 is to be formed. As described in U.S. Pat. No. 8,401,217, the number,
location and size of the holes 92, the dimensions of the slots 94, and the internal volume of the
rear chamber provide adequate damping of the movement of the membrane 40 by sufficient air
flow. It is selected to be able to offer. As described in US Pat. No. 8,401,217, the back chamber
functions as a reservoir for the flow of air through the holes 92 in the backplate.
[0034]
In the exemplary embodiment, the membrane 40 has a diameter of about 1.05 inches (0.0268
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meters). The membrane 40 may have the following characteristics / dimensions: Radius = 0.0134
meter Thickness = 2.54 × 10 <-5> meter Density = 8000 kg / m <3> Tension = 400 N / m
Surface density = 0.1780 kg / m <2> Stress = 47.045 PSI The microphone 22 may include an air
layer, which may have the following characteristics / dimensions: Air gap = 2.54 × 10 <-5>
meter Density = 1.25050 kg / m <3> Viscosity = 1.8 × 10 <-5> Pascal second Speed of sound
passing through the air gap = 290.2 meters per second Gamma = 1.4 Microphone 22 may
include a slot 94, which may have the following characteristics / dimensions: Distance from the
center of the back plate = 0.0117 meters Width = 0.00351 meters depth = 0.00114 meters area
= 0.000258 meters <2> The back plate 38 may define six holes 92, Each hole 92 may have the
following characteristics / dimensions: Distance from the center of the back plate to the center of
the hole = 0.00526 m Radius = 0.002 m Depth = 0.045 m Between the two straight lines from
the center of the back plate to either side of the hole Angle = 43.5 degrees Area = 1.26 × 10
<−5> meters <2> Also, the microphone 22 may have the following additional characteristics /
dimensions. Rear chamber volume = 5 × 10 <-5> meter <3> membrane mass = 480 kg / meter
<4> membrane compliance = 3.2 × 10 <-11> meter <5> / newton air gap compliance = 3 .5 x 10
<-10> meters <5> / Newton
[0035]
In one embodiment, the resonant frequency of the microphone 22 may be 3108.01 hertz.
[0036]
Preamplifier substrate 42 is flat and extends radially outward from the proximal end of
conductor 36.
The preamplifier substrate 42 is connected to the proximal end of the conductor 36 by any
suitable means such that an electrical connection exists between the preamplifier substrate 42
and the conductor 36 such as a brass screw 99. The preamplifier substrate 42 is parallel to the
end wall 36 of the body 30, the bottom wall 64 of the support plate 32, and the bottom wall 88
of the back plate 38. The position of the amplifier substrate 42 is defined by the first proximal
chamber 100 having a volume V1 between the preamplifier substrate 42 and the end wall 46 of
the main body 30, and the bottom wall 64 of the preamplifier substrate 42 and the support plate
32. A second distal chamber 102 is defined having a volume V2 therebetween. The slot 104 is
defined between the outer diameter of the preamplifier substrate 42 and the sidewall 44 of the
body 30 such that air flows from the distal chamber 102 to the proximal chamber 100. In an
embodiment, volume V1 is about 0.1287 cubic inches and volume V2 is about 0.6 cubic inches.
Air can flow from the distal chamber 102 to the proximal chamber 100 only through the slot
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104. In an embodiment, the slot 104 has a clearance distance of about 0.025 ′ ′ between the
outer diameter and the sidewall 44 of the preamplifier substrate 42, where the slot 104 extends
around the preamplifier substrate 42. There is.
[0037]
Electrical connections 106 extend through openings 62 in sidewall 44 and are sealed to sidewall
44 by suitable means. Electrical connection 106 is in electrical communication with preamplifier
substrate 42 via wires 108, 110. The preamplifier substrate 42 is also electrically connected to
the body 30 via the wire 110, which provides a ground for the preamplifier substrate 42.
Preamplifier substrate 42 measures the capacitance between membrane 40 and backplate 38
and includes known components for converting the measured capacitance to a voltage.
[0038]
The connection port 48 is connected to the proximal end of the flexible tube 26, which may be
formed of latex or rubber, having an earpiece 28 at the distal end of the tube 26. Such flexible
tubes 26 and earpieces 28 are known in the art for transmitting sound, like a typical stethoscope.
The flexible tube 26 is attached to the connection port 48 and the passage through the tube 26 is
through the distal chamber 100 and the passage 58 and the opening 56 so that there is no
exchange of air between the flexible tube 26 and the body 30. It is made to communicate. When
the earpiece 28 is inserted into a medical worker's ear, this may ensure that air does not
substantially exchange between the cavity 50 of the microphone 22 and the exterior of the
microphone 22. The length of the flexible tube 26 is adjusted so that the maximum audible
sound is received at the earpiece 28, which is used by the healthcare worker to listen to the
desired sound in real time.
[0039]
The combination of the volumes V1 and V2 and the slots 104 around the preamplifier substrate
42 provide sufficient acoustic resistance for pressure equalization and lower the low frequency
threshold. When the flexible tube 26 is connected to the earpiece 28, this reduces the low -3 dB
frequency to 0.03 Hz due to the increased acoustic resistance and the longer duration for
pressure equalization.
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[0040]
As described herein, the microphone may be different from that of US Pat. No. 8,401,217, in
which a connection port 48 is provided to connect the microphone 22 to the flexible tube 26 and
the earpiece 28, the body 30 is not completely sealed to the connection port 48, and the
preamplifier substrate 42 is horizontally mounted on the body 30 to divide the rear chamber into
two lower chambers 100 and 102, the preamplifier substrate 42 is horizontal to the membrane
40 and not perpendicular to the membrane 40 as in the position of U.S. Pat. No. 8,401,217, the
grid of U.S. Pat. No. 8,401,217 is removed, instead The point is that the body 30 includes threads
54 for connecting the body coupler 24 or 24a to the distal end of the body 30.
[0041]
The body couplers 24, 24a are threaded into the thread form 54 at the distal end of the body so
that there is no exchange of air between the body couplers 24, 24a and the body 30.
In one embodiment, as shown in FIG. 5, the body coupler 24 is formed with an outer ring 114,
which has attached thereto a flexible non-conductive diaphragm 116 that spans the diameter of
the ring 114. Outer ring 114 may be formed of either thermoplastic polyurethane elastomer
(TPU) or a closed cell polyurethane foam material that can be made with different densities, for
attaching outer ring 114 to the distal end of body 30. It has an internal thread form 118. TPU
material is used when the full spectrum of the acoustic signal from the heart is recorded, and
closed cell polyurethane foam material is only used when the very low frequency signal is
recorded, but it is a passive filter Act as the audible sound is separated. When attached, the
membrane 40 of the microphone 22 and the diaphragm 116 of the body coupler are separated
by about 0.1 inch. The body coupler 24 is placed on the patient's body during monitoring of the
physiological process. In another embodiment, as shown in FIG. 5A, the body coupler 24a has a
cup-shaped wall 120 having opposite proximal and distal ends defining a cavity 126 therein, and
a connection port extending from the distal end. It has 122. The connection port 122 has a
passage 128 therethrough which is in fluid communication with the wall 120 through the cavity
126 and the opening 130. The outer surface of the connection port 122 may have a thread form
thereon. The proximal end of the wall 120 is open and a thread form 124 is provided on the
inner surface of the wall 120. The wall 120 and the connection port 122 are formed of either
aluminum or brass. In the second embodiment of the body coupler 24a, the proximal end of the
flexible catheter tube 23 is attached to the connection port 122 and the thread form 124
engages the thread form 54 of the body 30 of the microphone 22. Thus, the connection between
the catheter tube 23, the body coupler 24a, and the microphone 22 is sealed so that air does not
enter through it. As is known, the catheter tube 23 has an opening 25 at the end of the tube 23.
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The end of tube 23 can be inserted into the patient's bladder 132 to provide internal fetal
monitoring. The bladder 132 is close to the uterus 134 and the transmission of sound, in
particular infrasound, is transmitted from the uterus 134 to the bladder 132, through the
opening 25 to the catheter tube 23 and to the microphone 22.
[0042]
As described herein, the preamplifier substrate 42 is mounted on the bottom wall 54 and parallel
to the membrane 24. The slot 104 between the end of the preamplifier substrate 42 and the side
wall 44 is small, for example 0.025 ", to increase acoustical resistance. The combined volumes V1
and V2 and the volume of the flexible tube 26 are 5 × 10 <−5> meters <3>. Due to the increase
in acoustic resistance, pressure equalization is longer, helping to lower the lower -3 dB frequency
to 0.03 Hz.
[0043]
In use, the body coupler 24 or catheter tube 23 detects incident sound pressure from the heart,
uterus, or other locations of the body in which it is placed. For example, as shown in FIG. 6, the
body coupler 24 may be located at locations A, P, T and / or M of the patient's body. The sound
pressure causes the movement of the membrane 40 in the microphone 22. Movement of the
membrane 40 changes the volume between the membrane 40 and the backplate 38. This
electrical signal propagates from the backplate 38 through the conductor 36 to the preamplifier
substrate 42, thereby producing a proportional output voltage at the preamplifier substrate 42.
The preamplifier substrate 42 is grounded via the wire 112. Signals are sent from the
preamplifier substrate 42 to the electronic substrate through the sealed electrical connection
106, which digitizes the data and transmits it wirelessly to a nearby computer. The received
signal is detected at a bandwidth of 0.03 to 1000 Hertz.
[0044]
The microphone 22 provides damping of the motion of the membrane 40 for flat frequency
response over the desired range by using the air gap 98 and the holes 92 in the backplate 38.
When the membrane 40 vibrates, the membrane 40 compresses and expands the air layer of the
air gap 98, producing a reaction pressure, which is opposite to the movement of the membrane
40. The reaction pressure creates an air flow, mainly in two places, ie in the air gap 98 between
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the membrane 40 and the backplate 38, and the holes in the backplate 38 providing a large
surface area for viscous boundary layer damping. At 92, introduce attenuation.
[0045]
As described in US Pat. No. 8,401,217, the tension of the membrane 40 may be less than about
1500 Newtons per meter in a 3 inch diameter ultra low frequency microphone 22. For example,
the radius of the membrane 40 may be about 0.0342 meters, and the tension of the membrane
40 may be less than about 1000 Newtons per meter. Also, the resonant frequency of the
microphone 22 may be less than about 1000 Hertz. In addition, the volume of the rear chamber
may be selected to produce low frequency air compliance that exceeds the compliance of the
membrane 40 by at least three times. In one example, the radius of the membrane 40 is about
0.0342 meters. In this example, the backplate 38 defines six holes 92, each having a radius of
approximately 0.00302 meters. The holes 92 are equally spaced along a virtual circle on the
backplate 38, and the centers of each hole 92 are aligned along the virtual circle. The center of
the imaginary circle is located coincident with the center of the back plate 38, and the radius of
the imaginary circle is about 0.0105 meters. The width of the slot 94 is about 0.0144 meters,
and the area of the slot 94 is about 0.00179 m 2.
[0046]
For an ultra low frequency microphone 22 of about 1.5 inches in diameter, the radius of the
membrane 40 may be about 0.0134 meters, and the tension of the membrane 40 may be less
than about 400 Newtons per meter. Also, the resonant frequency of the microphone 22 may be
less than about 1500 hertz. Furthermore, the volume of the rear chamber may be selected to
produce low frequency air compliance that exceeds the compliance of the membrane 40 by at
least 10 times. In another example, the radius of the membrane 40 is about 0.0134 meters. In
this example, the radius of each of the six holes 92 is about 0.002 meters, and the radius of the
imaginary circle is about 0.0117 meters. The width of the slot 94 is about 0.00351 meters, and
the area of the slot 94 is about 0.000258 m <2>. The volume of the rear chamber is about
0.00005 m <3>.
[0047]
As shown in the block diagram of FIG. 7, the signal from infrascope 20 is digitized through
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analog-to-digital digitizer substrate 140. Once digitized, the signal is transmitted wirelessly or by
cable to a workstation 142 such as a laptop or personal computer. At 144, time histories are
drawn for data collected at different patient locations, such as locations A, T, P and M as shown
in FIG. Workstation 142 provides management, analysis, and display of recorded data. MATLAB
may be used to process the data to generate real time spectrograms using short time Fourier
transform (STFT) spectra of the corresponding data at 146 and 148. The time history and
spectrograms of the biosignals are transferred by the Internet 150 to the remote workstation
152 for observation and analysis, if desired. An example of such a remote workstation 52 may be
a remote computer monitor, a smartphone or a tablet. The signal may be sent via a wired
connection to a PC or laptop for processing, and may be sent wirelessly, such as by using a
commercially available Bluetooth® module. The data may be converted to a useful visual format,
also referred to as a spectrogram, which may be beneficial to the physician diagnosing any
abnormalities. The display of the short-term spectrum is performed in real time to detect the
occurrence of short-term events in the data.
[0048]
FIGS. 8-17 show charts of infrascope signals collected at locations A, P, T and M of FIG. 6 with
reference to an electrocardiogram signal, commonly referred to as an ECG or EKG. Figures 18
and 19 are charts displaying Infrascope data compared to ECG or EKG for two different subjects
from 1 Hz to 1000 Hz. The ECG signals of both subjects are quite different, and the infrascope
signal also follows the ECG trend.
[0049]
The infrascope 20 can be used for testing of stress phonocardiography. Some heart problems
occur only during physical activity. A stress cardiocardiogram test can be accomplished using
signals from the infrascope 20 immediately before and after walking on a treadmill or riding a
stationary bicycle.
[0050]
The Infrascope 20 can be used to monitor the fetal heart during pregnancy, labor pain, and
parturition to track fetal heart rate and uterine contraction strength and duration. External fetal
heart monitoring places the body coupler 24 in the patient's abdomen and tracks the baby's
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heart rate when resting and moving, and the number of contractions and contractions during
labor and how long the contraction lasts It includes measuring and determining if there is an
early birth. Internal fetal heart monitoring is shown in FIG. 2 and uses the catheter 23 described
herein to determine whether labor stress stress threatens the health of the baby and measure the
strength and duration of labor contraction.
[0051]
As shown in FIG. 3, the infrascope 20 can be used for Doppler echocardiography. Doppler
echocardiography can be used to measure blood flow in the heart without invasive procedures.
Left ventricular filling pressure and blood flow can be estimated using two infrascopes 20.
Infrascope 20 may use, for example, positions A, P, T and M by using mounting structure 160
with adjustable rod 162 attached to microphone 22 to determine two-dimensional velocity
estimation and imaging. It can be placed at any desired position.
[0052]
Infrascope 20 can be used for biometric identification. Although fingerprints have been used for
over 100 years for identification, using a heart beat for biometrics has several advantages, such
as convenience and security. The heartbeat signature can be extracted by using either ECG / EKG
or by using the infrascope 20 at a remote location. Security features are ensured by the fact that
the user's ECG or acoustic signature can not be captured without the consent of the individual.
Another disadvantage of fingerprints is that they can be replicated using samples left behind. The
very low frequency band signal provides better and higher signal to noise ratio values and other
tools for biometrics.
[0053]
Infrascope 20 can be used for a lie detector. The physiological processes measured in polygraphs
are cardiovascular, cutaneous electricity and respiration. The direction and degree of
cardiovascular response may vary among individuals in response to stimuli that may be
considered arousal. Electrical skin activity in terms of skin resistance or conductance is measured
by applying an electrical current to the skin. Depending on the relevant questions controlled, the
change from the basal level is referred to as electro-skin or EDR response or electro-skin activity
level and is used for polygraph interpretation. Changes in respiration also alter heart rate and
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cutaneous electrical activity, and are monitored to determine if the response to the related
controlling question is an artifact. Currently, polygraph respiration rate and respiration depth are
measured by changes measured using strain gauges placed on the chest and abdomen.
Measurement of very low frequency signals can be performed by placing the infrascope 20 on
the subject's chest or abdomen, and is a relatively inexpensive tool for measuring changes in
respiration and cardiovascular activity.
[0054]
The infrascope 20 of the present disclosure allows medical personnel to view audible bandwidth
and ultra-low bandwidth, thereby providing other tools for medical personnel to analyze
physiological processes. The infrascope 20 can be used for respiratory, cardiac and fetal heart
monitoring. The infrastructure scope 20 makes it possible to transfer signals of physiological
processes to any place in the world in real time. The ambulance can be equipped with an
infrastructure 20 so that medical personnel can obtain the patient's physiological information in
real time. Infrastructure Scope 20 is a relatively inexpensive tool for diagnosing anomalies at an
early stage.
[0055]
The term "patient" as used throughout the present disclosure includes humans and animals since
it is expected that the present invention can also monitor physiological processes for veterinary
practice.
[0056]
All references disclosed herein are hereby incorporated by reference in their entirety.
[0057]
While specific embodiments are illustrated and described with reference to the drawings, it is
envisioned that one of ordinary skill in the art may devise various modifications without
departing from the spirit and scope of the appended claims.
Thus, the scope of the disclosure and the appended claims should not be limited to the specific
embodiments illustrated and described with respect to the drawings, but modifications and other
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embodiments may be included within the disclosure and the accompanying drawings. It will be
understood that it is intended.
Also, while the foregoing description and the associated drawings describe exemplary
embodiments in the context of specific example combinations of components and / or functions,
deviating from the scope of the disclosure and appended claims It should be understood that it
may be provided by alternative embodiments that do not.
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