Note: Descriptions are shown in the official language in which they were submitted.
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SENSOR, SENSOR PAD AND SENSOR ARRAY FOR DETECTING
INFRASONIC ACOUSTIC SIGNALS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S. Non-Provisional
Application No.
14/803,389, filed July 20, 2015, the relevant contents of which are
incorporated herein by
reference.
FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] N/A
FIELD OF THE INVENTION
[0003] The present invention generally relates to an infrasonic sensor,
sensor pad and sensor
array for holding a plurality of sensors in a set configuration. The sensor,
pad and/or array can
be utilized, for example, for non-invasive sensing and recording of blood flow
and other related
signals at very low hertz levels. The sensed information can be used to detect
the level of
stenosis, occlusion or aneurysm, if any, of arteries and other related
diagnosis of a living
organism.
BACKGROUND OF THE INVENTION
[0004] Infrasonic acoustic signals generated by a living organism can be
useful in the
detection and diagnosis of certain conditions or ailments of the organism. In
particular, blood
flow in the organism cause infrasonic acoustic signals (e.g., via vibration of
the arterial or venal
walls) that indicate possible extent of stenosis, occlusion or aneurysm in the
organisms' arteries
and/or veins.
[0005] U.S. Patent No. 7,621,875 describes one process for detecting
arterial disease using
sensed infrasonic acoustic signals. As described therein, sensed infrasonic
signals are analyzed
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by a computer or other similar device to generate a complex frequency grid of
frequencies and
associated lifetimes. A predictive model of complex frequencies associated
with peak-
perturbation acoustic signals attributed to boundary perturbations in vivo
that occur with early
stage arterial disease is provided. A predictive model of complex frequencies
associated with
line-perturbation acoustic signals attributed to boundary perturbations in
vivo that occur with
later stage arterial disease is also provided. It is then determined whether
peak and/or line-
perturbation acoustic signals of the predictive models are present to detect
whether the subject
has arterial disease.
[0006] U.S. Patent No. 5,853,005 discloses known transducers and acoustic
pads for sensing
acoustic signals in an organism. The devices shown in U.S. Patent No.
5,853,005 are difficult to
utilize, and can generate signal noise and/or spikes which can be disruptive
in proper analysis.
[0007] Quickly and easily setting up equipment to sense any acoustic
signals at the proper
locations on a subject can be of vital importance in an emergency. Even in non-
emergency
situations, ease of use is important in that it enables a medical technician
(or possibly a patient)
to administer the procedure and utilize the equipment without a doctor having
to be present.
[0008] The present invention provides an improved sensor, sensor pad and
sensor array for
sensing infrasonic acoustic signals.
SUMMARY OF THE INVENTION
[0009] The present system includes a sensor, a sensor pad and a sensor
array (holding a
plurality of sensors) for the passive detection of infrasonic signals
generated by a living
organism. In one embodiment, these components are combined with a touch panel
PC (i.e., a
main computing unit) with applications that interpret a sound signature from
the sensor array,
and analyze the sound features and spectrum to determine or define the
severity of stenosis, or
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narrowing within an artery, occlusion, 100 percent closure, or aneurysm. In
one embodiment,
the sensor array is designed to detect occlusion in the carotid arteries.
I00101 The sensor array is a highly sensitive acoustic capturing device,
capable of receiving
sound waves internal to the body that passively flow at a frequency range of
<1-20hz. The sensor
array is adjustably configured to account for the anatomical differences
between individuals, to
filter external noise and amplify the sound signature emitting passively from
the human body. In
accordance with one embodiment, the sensor array in collaboration with the
software or
application running on the PC or main computing unit, takes three readings
simultaneously from
the right and left carotid arteries in the neck and from the heart just below
the sternum, calibrates
the sound signature, filters and then digitizes data for analysis. A shielded
cable transmits the
signals to the main computing unit. The sensor array is adjustably designed to
fit any adult
person and be held by the patient for the test. There is no effect upon blood
circulation while the
test is being conducted. Most significantly, the system is designed to be a
passive test that is
non-emitting, non-invasive, and is configured so that anyone can conduct the
test without
requiring certification.
100111 Utilizing certain algorithms, such as those disclosed in U.S. Patent
No. 7,621,875 or
other similar algorithms, the present components can be utilized in a system
to identify the
systolic event, calibrate the signal, analyze the signal utilizing low
frequency (Spectral) methods
and assess the range of stenosis, occlusion or aneurysm within each carotid
artery. The system
first goes through a series of calibration steps, in concert with the sensor
array, ensuring correct
receipt of the signals, correlating the signals from the two carotid arteries
and the heart, and
identifying the systolic time, the period of most rapid fluid flow. Once the
signal is recorded, the
system prepares the data for processing the digital signal to conduct a
spectral analysis. Using
the signal features, a statistical analysis is performed against multiple
parameters to render a
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classification of degree of stenosis, occlusion or aneurysm within each
carotid artery. The output
renders a report indicating a range of blockage against the defined Nascet
categories with a
representation of the systolic events.
[0012] In accordance with one embodiment, the sensor array includes three
sensors, two of
which are positioned proximate the carotid arteries and one below the sternum.
The array
includes a structure having three branches for holding the sensors. The upper
two branches or
arms are flexibly connected to the third branch or base to allow for adjusting
the sensors to
properly position each sensor on the carotid arteries of bodies of different
sizes. In this regard,
the upper two branches are biased inward and can be bent/flexed outward to the
proper position.
To accommodate bodies of differing heights, additional modifications can be
made to allow for
the adjustment of the lower sensor with respect to the upper sensors (e.g.,
providing a telescoping
or otherwise extendable portion or arrangement in the lower branch and/or the
upper two
branches).
[0013] The sensors in the array are designed to be readily replaceable.
Each sensor includes
a disk shaped circuit between two conductive 0-rings. Each sensor also
includes a bag-type gel
pack or pad, or a solid gel pack or pad. The pad is used for contact with the
body. The pads are
meant to be disposable after each use, and the sensors require replacement
after about 50-100
uses.
[0014] In accordance with an embodiment of the invention a sensor pad for
transmitting
infrasonic acoustic signals to a sensor is provided. The sensor pad comprises
a bottom wall
having a flat circular surface for contact with a piezoelectric element. The
pad also includes a
contacting portion connected to the bottom wall. The contacting portion has a
circumferential
side wall extending upward from the bottom wall to a forward facing contacting
surface.
Additionally, the contacting portion includes a first outwardly concave region
forming an
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indentation or dimple in the contacting portion. The outwardly concave region
can be on the
forward facing contacting surface of the contacting portion. In this
configuration a rim forms
around the concave portion and is typically the first part of the pad that
comes into contact with a
body during use.
[0015] The pad is formed from a soft material having a low durometer value_
The pad is
configured to allow material in the pad to flow into the first outwardly
concave region upon
contact with a surface, such as a body. By allowing the material to flow in
this region, pressure
from the initial contact does not cause material to press against the bottom
wall connected to the
sensor.
[0016] In one embodiment the pad is formed as a liquid filled bag. The pad
comprises a
first sheet forming the bottom wall and a second sheet connected to the first
sheet forming an
outer wall of the contacting portion. The liquid is positioned in the interior
of the bag formed by
the two sheets. The sheets can be vinyl films or other similar materials, and
the liquid interior
can be liquid silicon.
[0017] The sensor pad can also comprise a lip portion circumferentially
around the bottom
wall extending radially outward past the side wall of the contacting portion.
The sensor pad can
be formed with only one outwardly concave region or it can include a second or
third outwardly
concave region in the contacting portion. In fact, it can have a plurality of
concave portions in
the contacting portion. Moreover, such regions can be formed in the contacting
surface and/or in
the side wall of the pad.
[0018] In a separate embodiment, the pad is completely formed from a
partially solidified
gel or liquid, such as a silicon gel. The bottom wall or surface of the pad is
preferably tacky,
enabling it to stick to a sensor element. In a preferred embodiment, the
solidified gel or liquid
creates a homogeneous material that provides for impedance matching.
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[0019] In accordance with yet another embodiment, a disposable sensor pad
for transmitting
acoustic signals from a body to a sensor is provided. The pad comprises a
circular disk of a low
durometer value material having an upper contacting portion for contacting a
body. The upper
contacting portion includes a circumferential side wall and a circular upper
surface. The upper
contacting portion also includes an indentation devoid of material. The pad
further includes a
bottom portion having a flat circular surface connected to the upper
contacting portion for
contacting a sensor element. The indentation can be a first outwardly concave
region in the
forward facing surface of the contacting portion.
[0020] The circular disk can be formed from two sheets of vinyl film filled
with a silicon
liquid. Alternatively, the circular disk can be formed from a partially
solidified silicon gel. A lip
can extend circumferentially around the disk radially outward from the side
wall of the
contacting portion.
[0021] In accordance with another embodiment of the invention, a sensor pod
for sensing
acoustic signals is provided. The sensor pod comprises a housing having an
interior chamber
and a circular opening. A piezoelectric element in the form of a circular disk
having a first side
and an opposing second side is contained in the interior chamber of the
housing and is aligned
with the circular opening. The piezoelectric element comprises a metal plate
with a ceramic
material contacting a side of the plate.
[0022] A first 0-ring is positioned on and in contact with the first side
of the piezoelectric
element and, a second 0-ring is positioned on and in contact with the second
side of the
piezoelectric element, maintaining the piezoelectric element between the 0-
rings. One or both
of the 0-rings can be electrically conductive and comprise an electrically
conductive material.
One example of an electrically conductive material is a metalized rubber. A
first conductive
contact element can be embedded or otherwise connected to the housing, and be
electronically
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coupled to the first 0-ring for transmitting signals generated by the
piezoelectric element. A
second contact element can be utilized for the second 0-ring.
100231 The housing can comprise a first upper housing portion connected to
a second lower
housing portion. Each portion can also be formed from one or more components.
Preferably,
the housing portions have a circular top view configuration centered about the
circular opening.
[0024] The sensor pod can further comprise an acoustic coupling pad having
a flat surface
contacting the first side of the piezoelectric element and a body contacting
portion extending
through the circular opening in the housing. Pads as described herein are
preferred; however,
other types of acoustic pads (such as a simple cylindrical disk of appropriate
material lacking
some of the structural features described above) may work with the sensor pod.
100251 An amplifier circuit electrically coupled to the piezoelectric
element can be
contained in the interior chamber of the housing. The amplifier circuit can
be, for example, on a
board. Other similar circuitry could also be similarly positioned in the
chamber.
100261 The housing further comprises a swivel connector extending from a
bottom portion
of the housing. The swivel connector enables the pod to be connected to a
support structure,
such as the arrays disclosed herein, and enables the pod to pivot about the
connection. Other
types of connections can also be implemented with the pod that allow for the
pod to pivot or
rotate about the connection. In addition to the swivel connector, a ball and
socket connector, a
flexible tube connector, a bayonette mount, twist lock mount, or other similar
device.
[0027] In accordance with another embodiment of the invention, a sensor pod
for sensing
infrasonic acoustic signals in a living organism is provided. The sensor pod
comprises a sensor
housing having an internal chamber and an opening. A piezoelectric element is
mounted in the
internal chamber. The piezoelectric element comprises a metal plate having a
first side and an
opposing second side. The first side of the plate has a piezo-type material
coating at least a
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portion of the first side. The piezoelectric element is positioned to span
across the opening,
essentially dividing the internal chamber into an outer chamber portion
configured to receive an
acoustic coupling pad and an inner chamber portion. An amplifier circuit is
mounted in the inner
chamber portion of the housing and electrically coupled to the piezoelectric
element. The
housing comprises a metal surface around the inner chamber portion such that
the metal surface
of the housing and the metal plate of the piezoelectric element form a faraday
cage around the
amplifier circuit.
100281 The housing can comprise a first housing portion and a second
housing portion
connected to the first housing portion. In this configuration, the inner
chamber portion is
preferably formed in the second housing potion. Other aspects of the other
embodiments
described can also be utilized in this embodiment.
[0029] The sensor pod can further comprise a low durometer value pad having
a bottom
wall positioned against the first side of the piezoelectric element and a
contacting portion
connected to the bottom wall which extends outward through the opening in the
housing. The
contacting portion of the pad includes an outwardly concave region.
[0030] In accordance with yet another embodiment of the invention, a sensor
array for
positioning a plurality of acoustic sensors on a living organism is provided.
The sensor array
comprises a sensor support structure having a base portion which includes a
first connection
element for connecting a first sensor to the base portion. A first arm extends
from the base
portion and includes a second connection element for connecting a second
sensor to the first arm.
A second arm also extends from the base portion and includes a third
connection element for
connecting a third sensor to the second arm. The sensor pods described herein
can be used as the
sensors to be connected to the array.
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[00311 The support structure is configured to position the first, second
and third sensors at
appropriate locations on the living organism. To facilitate proper
positioning, the first arm and
the second arm flexibly connected to the base portion. Additionally, the first
arm and second
arm can be adjustable to enable movement between the sensors. In this regard,
one or both arms
can be extendable, such as by a telescoping feature. Similarly, the base
portion can be
configured to include a tongue portion (which holds the sensor) which can be
extendable.
[0032] The sensor array can further comprise a handle formed in the support
structure to
enable a user to grasp the sensor array and hold it in a proper location. In
one embodiment, the
base portion can also be used as a handle.
[0033] The first, second and third connection elements can be configured to
mate with a
swivel ball connector on a sensor pod housing. Other connection means could be
also be used.
[0034] The support structure is configured to enable a cable or other
electrical connection to
transmit signals generated by the sensors to a computing device for analysis
and/or display. In
this regard, the base portion can be hollow or otherwise include a path for
placement of a cable
or other conductive element for transmitting signals generated by a sensor
connected to the first
connecting element to a computing device. Similarly, the first and second arms
can be hollow or
otherwise include a path for placement of a cable or other conductive element
for transmitting
signals generated by a sensor connected to the second connecting element to
the computing
device.
[0035] The sensor array can be formed from a hard plastic. Other suitable
materials can
also be used.
[0036] In other embodiments, the array can include more or fewer
connections for sensors.
Similarly, the array can include more or less arms depending on the number of
sensors needed.
The arms can be positioned in configurations to employ the sensors in the
needed positions.
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Moreover, each arm can include more than one sensor, if needed. The sensors
can be mounted to
be slidably and/or rotatably attached to the arm.
100371 In accordance with another aspect Of the invention, an assembly for
converting
acoustic signals into electrical signals is provided. The assembly comprises a
thin disk-shaped
piezoelectric element. The element includes a circular metal sheet having a
first side and an
opposing second side, and a first radius. The metal sheet can be a stainless
steel or other similar
or suitable materials. A piezo-type material is connected to or coated on the
first side. The
assembly further includes a first conductive 0-ring abutting the piezo-type
material on the first
side of the metal sheet, and a second conductive 0-ring abutting the second
side of the metal
sheet. The first and second 0-rings can be formed from a metalized rubber.
100381 The piezo-type material can be a ceramic material. The ceramic
material can be
configured in circular pattern located in the center of the first side of the
metal sheet.
Additionally, the ceramic material can be configured to define a plurality of
distinct (i.e.,
discrete, or non-touching) sections devoid of material. The ceramic material
can be configured
in at least two sections, or can have three, four or twelve sections. Other
configurations having
different numbers of sections can be used. Preferably the number is chosen to
maintain balance
in the piezoelectric element. The centrally located ceramic material includes
two or more
segments that extend radially outward to contact the first 0-ring. The
segments can be used to
define the sections devoid of material. The segments can extend from the
centrally located
ceramic material to an outer ring of ceramic material proximate an outer edge
of the disk.
[00391 The assembly can be electronically coupled to an amplifier circuit
through the first
and second 0-rings. In one embodiment, the first 0-ring acts as an
electrically positive lead for
the assembly and the second 0-ring acts as a negative or ground lead for the
assembly.
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100401 In accordance with another aspect of the invention, a disposable
sensor pad for
transmitting acoustic signals from a body to a sensor comprising a circular
disk of a low
durometer value material having an upper contacting portion having a forward
facing surface for
contacting a body, wherein the upper contacting portion includes a
circumferential side wall and
a circular upper surface and a bottom portion having a flat circular surface
connected to the
upper contacting portion for contacting a sensor element, a circumferential
concave groove, and
a circumferential lip on the outer portion of the circumferential concave
groove, wherein the
forward facing surface is suitable for contacting a body and the bottom
portion is suitable for
being positioned onto a piezoelectric element for sensing acoustic signals;
wherein the bottom
portion of the disposable sensor pad distorts less than 5% upon a force being
applied to the
forward facing surface.
100411 A further embodiment is directed to a sensor pod for sensing
acoustic signals
comprising: a housing having an interior chamber and a circular opening at one
end, and a ball
and socket connector at an opposing end of the housing configured for
attachment to a support
structure for adjustably moving the sensor pod in multiple directions; a
piezoelectric element in
the form of a circular disk having a first side and an opposing second side
contained in the
interior chamber of the housing and aligned with the circular opening; a
disposable acoustic
sensor pad having a flat surface portion on a first side contacting the first
side of the piezoelectric
element and a body contacting portion on a second side, extending through the
circular opening
in the housing, and a portion of the body contacting portion extending outward
from the opening
in the housing; a first 0-ring positioned on and in contact with the first
side of the piezoelectric
element, a second 0-ring positioned on and in contact with the second side of
the piezoelectric
element; and wherein the second 0-ring includes a circumferential groove
positioned so that an
edge of the piezoelectric element sits in the groove.
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[0042] A sensor pod for sensing acoustic signals comprising: a housing
having an interior
chamber and a circular opening at one end, and a connector at an opposing end
of the housing
configured for attachment to a support structure for adjustably moving the
sensor pod in multiple
directions; a piezoelectric element in the form of a circular disk having a
first side and an
opposing second side contained in the interior chamber of the housing and
aligned with the
circular opening; a disposable acoustic sensor pad having a flat surface
portion on a first side
contacting the first side of the piezoelectric element and a body contacting
portion on a second
side, extending through the circular opening in the housing, and a portion of
the body contacting
portion extending outward from the opening in the housing; a first 0-ring
positioned on and in
contact with the first side of the piezoelectric element; a second 0-ring
positioned on and in
contact with the second side of the piezoelectric element; and wherein the
second 0-ring
includes a circumferential groove positioned so that an edge of the
piezoelectric element sits in
the groove.
[0043] Further aspects of the invention are disclosed in the description of
the invention
including the Figures.
BRIEF DESCRIPTION OF THE FIGURES
[0044] To understand the present invention, it will now be described by way
of example,
with reference to the accompanying Figures and attachments in which:
[0045] FIG. 1 is top perspective view of a sensor pad in accordance with
the present
invention.
100461 FIG. 2 is a cross-sectional view of a first embodiment of the sensor
pad of FIG. 1.
[0047] FIG. 3 is a cross-sectional view of a second embodiment of the
sensor pad of FIG. I.
100481 FIG. 4 is a cross-sectional view of a prior art sensor pad.
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[0049] FIG. 5 is a side view of a sensor or sensor pod in accordance with
the present
invention.
[0050] FIG. 6 is a perspective view of the contacting portion of the sensor
pod of FIG. 5.
[0051] FIG. 7 is a cross-sectional view of the sensor pod of FIG. 5.
[0052] FIG. 8 is an enlarged portion of the cross-sectional view of FIG. 7.
[0053] FIG. 9 is an exploded view of an embodiment of a sensor or sensor
pod in
accordance with the present invention.
100541 FIG. 10 is an exploded perspective view of an 0-ring - piezoelectric
element
assembly.
[0055] FIG.11 is a perspective view of the 0-rings and piezoelectric
element of FIG. 10
assembled.
100561 FIG. 12 is a cross-sectional view of a modified 0-ring with a
piezoelectric element in
accordance with a further embodiment of the present invention.
100571 FIG. 13 is a top plan view of one embodiment of a piezoelectric
element in
accordance with the present invention.
[0058] FIG. 14 is a top plan view of another embodiment of a piezoelectric
element in
accordance with the present invention.
100591 FIG.15 is a top plan view of another embodiment of a piezoelectric
element in
accordance with the present invention.
[0060] FIG. 16 is a top plan view of another embodiment of a piezoelectric
element in
accordance with the present invention.
100611 FIG. 17 is a top plan view of another embodiment of a piezoelectric
element in
accordance with the present invention.
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[0062] FIG. 18 is a perspective view of a sensor array having three sensors
in accordance
with apparatuses of the present invention.
100631 FIG. 19 is a perspective view of the sensor array of FIG.18 in use.
[0064] FIG. 20 is an exploded view of a sensor array and three sensors in
accordance with
one embodiment of the present invention.
[0065] FIG. 21 is a top plan view and a cross-sectional view of a mold for
forming sensor
pads in accordance with an embodiment of the invention.
100661 FIG. 22 is a perspective view of an alternative sensor array
positioned for use on a
patient.
[0067] FIG. 23 is a perspective view of another alternative sensor array
positioned for use
on a patient.
[0068] FIG. 24 is a front perspective view of another alternative sensor
array positioned for
use on a patient.
[0069] FIG. 25 is a side perspective view of the array of FIG. 24.
[0070] FIG. 26 is a front perspective view of another alternative sensor
array positioned for
use on a patient.
[0071] FIG. 27 is a side perspective view of the array of FIG. 26.
[0072] FIG. 28 is a front perspective view of another alternative sensor
array positioned for
use on a patient.
[0073] FIG. 29 is a side perspective view of the array of FIG. 28.
[0074] FIGS. 30 A-X depict six different sensor pads shown from top down (A-
F), side cut-
out profile (G-L), Side profile (M-R), and top perspective view (S-X).
100751 FIGS. 31 A-T depict five different sensor pads shown from top down
(A-E), side
cut-out profile (F-J), Side profile (K-0), and top perspective view (P-T).
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[0076] FIGS. 32 A-BB depict seven different sensor pads shown from top down
(A-G), side
cut-out profile (H-N), Side profile (0-U), and top perspective view (V-BB).
[0077] FIG S. 33 A-BB depict seven different sensor pads shown from top
down (A-G),
side cut-out profile (H-N), Side profile (0-U), and top perspective view (V-
BB).
[0078] FIG S. 34 A-X depict six different sensor pads shown from top down
(A-F), side cut-
out profile (G-L), Side profile (M-R), and top perspective view (S-X).
[0079] FIG S. 35 A-T depict five different sensor pads shown from top down
(A-E), side
cut-out profile (F-J), Side profile (K-0), and top perspective view (P-T).
[0080] FIG S. 36 A-T depict five different sensor pads shown from top down
(A-E), side
cut-out profile (F-J), Side profile (K-0), and top perspective view (P-T).
[0081] FIG S. 37 A-T depict five different sensor pads shown from top down
(A-E), side
cut-out profile (F-J), Side profile (K-0), and top perspective view (P-T).
DETAILED DESCRIPTION OF THE INVENTION -
[0082] While this invention is susceptible of embodiments in many different
forms, there is
shown in the Figures and will herein be described in detail preferred
embodiments of the
invention with the understanding that the present disclosure is to be
considered as an
exemplification of the principles of the invention and is not intended to
limit the broad aspect of
the invention to the embodiments illustrated.
[0083] The present invention provides a sensor - in the form of a sensor
pod - for detecting
infrasonic acoustic signals created or generated by a living organism, such as
signals caused by
blood flow through one or more veins or arteries. The invention also includes
improved gel
packs or pads utilized with the sensor. The pads act as an acoustic coupling
mechanism between
the sensor and the living organism. The pads are made from materials designed
to match a
body's impedance to allow acoustic signals to pass efficiently to the sensor.
Additionally, the
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invention includes a sensor array containing one or more sensors. The array is
utilized to allow
someone (and in some cases the patient) to easily and quickly place and hold
the sensors in
appropriate locations on the living organism to detect signals generated by
the organism. The
array is preferably designed to be adjustable to fit living organisms of
varying sizes.
[0084] The sensors, pads and arrays of the present invention are useful in
detecting signals
in the living organism that can be analyzed to determine various medical
conditions. As noted
above, U.S. Patent 7,621,875 discloses one use for detecting and diagnosing
possible stenosis,
occlusion, aneurysm or other shape of wall irregularity in certain arteries.
[0085] FIG. 1 shows a sensor pad 10 having a generally circular shape in
accordance with
the present invention. The sensor pad 10 is design to contact a body of a
living organism at a
desired location and transmit acoustic signals from the body to a
piezoelectric plate of a sensor
(discussed in more detail below). The pad 10 is designed to match the
impedance of the body to
enable efficient transfer of signals (while it is contemplated that the
disclosed sensors, pads and
arrays could be used - either separately or in combination - with many types
of living organisms,
and possibly inanimate objects, the use of these components will be
predominately described
with respect to detection of signals generated by a human body). Such
impedance matching
reduces reflection of any sound waves and facilitates maximum signal transfer
to the sensor.
[0086] Referring also to the cross-section of FIG. 2, one embodiment of the
sensor pad 10 is
in the form of a flexible, soft bag filled with a gel or liquid. The bag is
formed from a first,
circular flat sheet or layer 12 of vinyl forming a bottom wall, and a second,
outer sheet or layer
14 of vinyl forming a body contacting portion. A silicon based fluid or gel 16
is contained
between the two layers 12, 14. The pad 10 includes a lip 18 which is formed
from a portion of
the first, flat layer 12 extending radially outward from a location where the
outer layer 14
contacts the flat layer 12. The lip 18 extends circumferentially around the
pad 10.
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[0087] The outer layer 14 includes a side wall 20 that extends upward from
the flat layer 14
to a rim 22 (directional terms, such as "upward" are used herein to help
describe features of the
components as shown in the drawings and are not meant to limit the invention -
many of the
components will be used in multiple orientations). The top portion of the
outer layer 14 includes
an outwardly concave indentation or dimple 24.
[0088] The outer sheet 14 initially starts as a flat sheet of material that
is vacuum formed
into a mold 134 having the desired outer shape of the pad 10 (see FIG. 21 for
a top plan view and
a cross-sectional view of a plurality of molds 134 for forming the pad 10).
The silicon gel or
liquid 16 is then added, and the flat layer 12 is positioned over the outer
layer 14 and gel/liquid
16. The flat layer 12 is then vacuum sealed to the outer layer 14. This
process causes the
outer layer 14 to slightly melt into the flat layer 14 where they contact each
other.
[0089] In use, the flat layer 12 of the pad 10 is positioned against the
outer surface of the
piezoelectric plate or element of the sensor (again, discussed in more detail
below). Portions of
the outer layer 14 are used to contact the body to sense acoustic signals.
[0090] A prior, bag-type sensor pad (FIG. 30 from U.S. Patent No.
5,853,005) is shown in
cross-section in FIG. 4. The reference numbers provided in FIG. 4 were the
ones designated in
U.S. Patent No. 5,853,005 and are not related to the reference numbers used to
describe the
present inventions. As shown, the prior pad (designated as 186) includes a
domed, outwardly
convex outer surface - which is used to contact a portion of the body. Upon
such contact, when
the outer surface of this prior pad meets resistance from the body the domed
shape compresses,
forcing fluid or gel in the bag back into the flat base surface on the bottom
of the pad. This, in
turn, causes the flat surface to distort (i.e., bend outward) and press into
the sensor. The
distortion of the flat surface results in an undesired acoustic spike or noise
by the sensor.
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[0091] In contrast to the prior art pads, the present pad 10 includes the
concave indentation
or dimple 24. Upon contact with a body, gel or liquid is dispersed evenly into
the dimple region
allowing the flat layer 12 to remain flat and not distort under typical use.
[0092] While a centrally located indentation or dimple 24 is shown in the
Figures, the pad
could have alternative configurations that create the same benefits. For
example, the pad 10
could include additional dimples, or could have a plurality of smaller dimples
rather than the
large central dimple. Additionally, the dimples or indentations could be
formed in different
locations, such as in the side wall 20 of the outer layer 14.
[0093] A second embodiment of the pad 10 is shown in cross-section in FIG.
3. This pad
includes a flat, bottom surface 26, and an upper contacting surface 28. A rim
30 can extend
around the outer contacting surface proximate the flat, bottom surface 26.
[0094] The second pad embodiment has generally the same (or substantially
similar) outer
shape as the fluid filled, bag-type sensor pad shown in FIG. 2. However, in
this embodiment, the
pad 10 is completely formed from a partially solidified gel or liquid, such as
silicon. Such
solidified gel or liquid provides for a substantially or completely
homogeneous material for
impedance matching. Accordingly, the sensor pad 10 of FIG. 3 is of one-piece
construction.
Notwithstanding this, the pad operates in a similar manner as the bag-type
embodiment. That is,
material in the pad moves or fills in the indentation or dimple region upon
contact with a body
rather than distorting the bottom flat surface (i.e., the sensor contacting
surface).
[0095] Preferably, the sensor pad 10 has a "tacky" bottom surface, allowing
it to stick to the
piezoelectric element of the sensor in use. Because the tacky surface allows
the pad to stick to
the sensor, it may not be necessary to provide the lip 30 in this embodiment.
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100961 The pad of FIG. 3 can be formed from a single partially solidified
material.
Alternatively, it may be possible to use more than one partially solidified
material to form the
pad. The materials could be combined or formed in layers or other similar
arrangements.
100971 In both embodiments, the pads are designed to be very soft, having a
low durometer
value (e.g., in the range of 1-2 durometers). While soft silicon and vinyl
materials are suitable
for forming the pads (as discussed above), other similar - low durometer -
materials may also be
used.
100981 The sensor pads 10 are preferably used as part of a sensor or sensor
pod 32 shown in
FIGS. 5-8. As illustrated in FIG. 5, the sensor pod 32 includes a housing
having a first upper
housing portion 34 and a second lower housing portion 36 connected to the
first housing portion
34 (again, terms such as "upper" and "lower" are used with reference to
certain Figures and are
not meant to limit the sensor pod to any particular orientations). The housing
portions 34, 36 can
be of single piece construction or can include multiple components or pieces.
[0099] A swivel connector 38 is connected to or integrally formed as part
of the second
housing portion 34. The swivel connector 38 is used to connect the sensor pod
32 to a sensor
array and allows the sensor pod to pivot to an appropriate position in use.
The housing portions
34, 36 can be formed from an injection molded plastic.
101001 Referring also to FIGS. 7 and 8, the flat surface of the sensor pad
10 is placed in
contact with a piezoelectric element 40. The contacting surface or portion of
the sensor pad 10
extends above or outward from the first housing portion 34, and can be placed
in contact with a
body. The pad 10 acts as an acoustic coupling mechanism and relays acoustic
signals sensed in
the body to the piezoelectric element 40.
101011 The piezoelectric element 40 is in the form of a circular metal
plate having a ceramic
coating on a first or upper side of the plate, however other piezo-type
materials can be utilized.
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The piezoelectric element 40 is supported between a first or upper 0-ring 42
and a second or
lower 0-ring 44. The 0-rings 42, 44 are formed from a metalized rubber and are
used to conduct
electrical signals generated by the piezoelectric element 40 in response to
infrasonic acoustic
signals from the body. The 0-rings 42, 44 replace direct contact wires that
were typically
soldered to portions of the plate.
[0102] The arrangement of the 0-rings 42, 44 about the piezoelectric
element 40 allows the
piezoelectric element 40 to more freely vibrate and bend in response to sensed
acoustic signals
than it would have if direct contact wires were utilized In this regard, the 0-
rings 42, 44 do not
rigidly hold the piezoelectric element 40. The first 0-ring is designed to
abut or contact only the
piezo-electric material on the first side of the metal plate. Accordingly, the
radius of the 0-ring
should be chosen to with the radius and pattern of the coating material in
mind. Additional
aspects of the piezoelectric element 40 and 0-rings 42, 44 are discussed in
more detail below
with respect to FIGS. 12 -17.
101031 The first housing portion 34 presents a circular face 46 with a
central opening 48. As
mentioned, an upper contacting portion of the pad 10 extends outward from the
sensor pod 32
through the central opening 48 in the first housing portion 34. The first
housing portion 34
further includes an inwardly directed, circumferential segment 50 extending
from the face 46
toward the piezoelectric element 40. The inwardly directed segment 50 can be
sized to extend
over the lip 18 of the pad 10 to secure the pad 10 to the sensor pod 32.
Again, if the pad 10 has a
tacky bottom wall it may not be necessary to include the lip 18 in order to
maintain the pad 10 in
position on the sensor pod 32.
[0104] The first housing portion 34 also includes a circumferential outer
side wall 52 which
can be clipped, screwed or otherwise attached to the second housing portion
36. The combined
housing portions 34, 36 form a chamber for holding the piezoelectric element
40 and pad 10.
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The chamber also contains an amplifier board having an amplifier circuit for
amplifying the
signals generated by the piezoelectric element 40 and transmitting them to a
computer (or other
similar device) for analysis and/or display. In order to shield the amplifier
board from noise and
other stray signals, the housing portions 34, 36 are provided with a metal
surface which, when
combined with the metal plate of the piezoelectric element 40, form a Faraday
cage around the
amplifier board and any other circuitry positioned in the chamber.
[0105] Referring to FIG. 8, the first housing portion 34 includes a first
conductive contact
element 54 which is positioned to be in contact with the first 0-ring 42. The
second housing
portion 44 similarly includes a second conductive contact element 56 in
contact with the second
0-ring 44. The conductive elements 54, 56 relay the signals to the amplifier
board which in turn
passes the amplified signal - preferably via shielded cable - to the computer.
The first and
second conductive contact elements 54, 56 can be in the form of metal rings
secured in
appropriate positions in the respective housing portions. One or both of the
conductive contact
elements can be spring loaded to maintain proper contact with the
corresponding 0-ring.
[0106] FIG. 9 discloses an exploded view of one embodiment of the sensor
pod 32. Starting
at the top, the sensor pod 32 of FIGS. 5 and 6 includes a pad 10 followed by
an outer portion 58
of the upper housing portion 34 and an inner portion 60 of the upper housing
portion 34. Below
the inner portion 60 is the first conductive contact element 54, followed by
the upper 0-ring 42,
the piezoelectric element 40 and the lower 0-ring 44. Two screws 62 are
aligned with holes in a
PCB assembly 64 positioned below the lower 0-ring 44. An inner portion 66 of
the lower
housing portion 36 and an outer portion 68 of the lower housing portion 36
follow, with the
swivel ball or connector 38 at the lowest point.
101071 FIG. 10 discloses an exploded view of one embodiment of the 0-rings
42, 44 and
piezoelectric element 40, and FIG. 11 shows these components in an assembled
state. The 0-
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rings and piezoelectric element form an assembly that freely holds the
piezoelectric element for
optimal transmission of the sensed acoustic signals (this assembly formation -
using 0-rings -
can also be utilized with other piezo-type devices and is not necessarily
limited to the sensors
and uses described with respect to the preferred embodiments herein). In this
assembly, the
upper 0-ring 42 is the positive conductive element and the lower 0-ring 44 is
the negative or
ground conductive element.
[0108] In accordance with a further embodiment of the invention, one or
both of the 0-rings
can be modified to include structure to more effectively maintain the
piezoelectric element 40.
As shown in cross-section in FIG. 12, the second 0-ring 44 is provided with a
circumferential channel or groove 70. The radius of the 0-ring is set so that
the edges of the
piezoelectric element 40 sit in the channel 70.
101091 Another key to optimal transmission of the sensed acoustic signals
is for the 0-ring -
piezoelectric element assembly to be balanced. When wires are soldered to the
piezoelectric
element (in instances where 0-rings are not used), the element is not
necessarily balanced which
can impair the acoustic signal.
[0110] Balancing of the piezoelectric element 40 is further enhanced by the
pattern of the
ceramic or other piezo-type material used. As shown in FIGS. 13-17
piezoelectric element 40 is
provided with a centrally located region of ceramic coating 72 surrounded by
two or more
distinct (i.e. separate) sections 74 devoid of the ceramic material. Each
section is defined by a
spoke or segment 76 of material on either side extending radially from the
centrally located
region to a rim or edge of the metal plate of the piezoelectric element 40.
[0111] As shown in FIG. 13, a thin ring 78 of ceramic material can be
provided at the edge.
The ring 78 is connected to the central region of ceramic coating 72 by the
segments 76. A ring
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80 of the metal plate extends radially outward from the ring of ceramic
material 78. The 0-ring
42 is sized to abut the ring of ceramic material 78 without contacting the
metal plate.
[0112] FIG. 13 shows twelve sections 74 devoid of ceramic material. FIG. 14
shows a
pattern with three sections 74 devoid of ceramic material. In the embodiment
of FIG. 14, the
radially extending segments 76 are thicker than the segments used in the
embodiment of FIGS/
16 or 17.
[0113] FIG. 15 shows an alternative pattern having three sections 74 devoid
of material. In
this pattern, the radially extending segments 76 have a curved and flared
appearance.
[0114] FIGS. 16 and 17 shows a piezoelectric element having a ceramic
pattern with two
sections and four sections 74 devoid of material, respectively. While certain
patterns are shown
in FIGS. 13-17, other potential patterns could be used.
101151 The sensors or sensor pods 32, along with the sensor pads 10, are
preferably used
with an array that holds one or more sensor pods 32 in a structure designed to
allow for fast and
easy placement of the sensor pods 32 at the proper locations of the body. The
array structure is
designed based on the type of analysis being performed, the number of sensors
needed and the
approximate location of sensed signals on the body.
[0116] FIGS. 18 and 19 disclose a sensor array 90 for holding three sensor
pods 32. The
array 90 includes a generally cylindrical base portion 92 connected to a first
sensor pod 32. A
first arm 94 connected to a second sensor pod 32 and a second arm 96 connected
to a third sensor
pod 32 extend upward from an end of the base portion 92.
[0117] As shown in FIG. 19, the sensor array is designed to position the
first sensor pod 32
over a patient's heart, and to locate the second and third sensor pods 32
proximate the carotid
arteries in the patient's neck. Sensed infrasonic signals from these locations
can be analyzed to
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detect potential occlusions. An example of a process for making such an
analysis is disclosed in
U.S. Patent No. 7,621,875.
[0118] To facilitate proper placement, the first and second arms 94, 96 are
designed to be
able to twist and flex outward or inward relative to each other and the base
portion 92.
Additionally, the sensor pods 32 are preferably connected to the array 90 via
the swivel ball
connector 38 discussed herein. This allows the pods 32 to rotate about the
connector and be
moved and positioned in the proper sensing locations.
[0119] The base portion 92 of the array 90 can be sized or otherwise
configured to function
as a handle for the array 90. Alternatively, a separate handle structure can
be connected to the
array 90. The handle allows one (either the patient or someone else, such as a
medical
technician) to easily grasp the array and hold all three sensors in the proper
positions with one
hand. Straps are not needed to attach the sensor pods to the body.
[0120] The base portion 92 and/or the first arm 94 and/or the second arm
96, can be
configured to be extendable (e.g., such as by having telescoping components)
to enable one to
adjust the size of the array 90. With the extension features and/or the other
adjustable features
described, the array 90 can be used for a large variation in body sizes and
shapes.
[0121] The array 90 can be made of plastic or other similar materials. The
components (i.e.,
base portion 92, first arm 94 and second arm 96) of the array 90 are hollow to
allow a path for
one or more wires or shielded cables to connect to the sensor pods 32 to
transmit sensed signals
from the pods 32 to a computer or other device for analysis and/or display.
101221 As shown in FIG. 19, the array 90 disclosed is specifically sized
and configured to
position three sensors on a body for proper sensing of the carotid arteries.
However, the
structure of the array can be modified for sensing other arteries or veins, or
other physiological
aspects of a living organism. More or fewer sensors can be used as needed for
such structures.
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[0123] FIG. 20 provides an exploded view of a three sensor array 100 with
an embodiment
of a sensor pod 102 that can be easily replaceable. The array 100 includes a
base portion 104
having a first arm 106 and a second arm 108 extending from the top of the base
portion 104. As
shown, the features of the array 100 include a first side frame structure 110
and an overmold
112. A second side frame structure is broken into two pieces, a second side
base portion 114 and
an overmold base portion 116, and a second side arm portion 118 and second
side overmold
portion 120. An extendable tongue 122 is maintained in the base portion 104
between the first
side frame structure and second side frame structure. A circular knob 124 is
positioned at the
juncture of the first and second arms 106,108 with the base portion 104.
Twisting of the knob
124 causes the arms 106, 108 to flex outward or inward, and holds the arms in
the flexed
position.
[0124] A connector element 126 is positioned at the distal ends of the
first and second arms
106,108, and in the base portion 104. The connector is configured to receive a
swivel ball
connector 128 on the sensor pod 102. Other connection elements can be used.
Also, it is
possible for the connection elements to be reversed (place the swivel ball on
the array and the
receiving structure on the pod).
[0125] The swivel ball 128 of the sensor pod 102 is formed in a plurality
of segments 129
that can flex relative to each other. This allows the swivel ball 128 to snap-
fit into the connector
element 126 at the base of the pod 102. This enables one to easily remove and
replace a new
sensor pod when necessary. It is anticipated that a new sensor pod will be
needed after every
50100 uses. New pads are used after each use.
[0126] As is evident in FIG. 20, the array 100 has an essentially hollow
construction. This
enables shielded cables to connect to the sensor pods and travel to central
cable 130 plugged into
the bottom of the base portion 104.
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[0127] FIG. 22 illustrates another embodiment of an array structure 150 for
positioning
three sensor pods 152. The array 150 includes a handle or base portion 154
having a first arm
156 extending from the handle 154. A second arm 158 is connected to the first
arm 156
proximate the handle 154 by a rotatable connector 160.
[0128] A first sensor pod 152 is connected to the first arm 156 by a
connector 162.
Similarly, a second sensor pod 152 is connected to the second arm by a
connector 164. The
connectors 162, 164 are mounted to the respective arms 156, 158 and (as
indicated by the
arrows) are configured to be slideable up and down the arms and to be able to
rotate about the
arms in order to position the pods 152 in the appropriate positions.
[0129] A third sensor pod 152 is connected to the second arm 158 at the
juncture where the
second arm is connected to the first arm 156. A cable 166 is plugged into an
end of the handle
154 for transmitting sensed signals to a computing and/or display device.
[0130] FIG. 23 illustrates yet another array structure 168 for holding
three sensor pods 152
(to sense signals from the femoral arteries). The array 168 includes a handle
170 and a single
arm 172 extending upward from the handle 170. A first sensor pod 152 is
connected at a distal
end of the arm 172 (from the handle 170) by a connector 173 similar to the
connectors of FIG.
22. A double connector 174 is used to connect two sensor pods 152 proximate
the handle 170.
While the handle is shown below the double sensor connector 174, a patient or
medical
technician can gasp a mid-section of the arm 172 to keep the sensors in place
during testing.
[0131] FIGS. 24 and 25 disclose another embodiment of an array structure
180 having a
base portion 182 and a first arm 184 and a second arm 186 extending outward
from an end of the
base portion 182. The base portion 182 includes a tongue 188 that is slideable
within an upper
portion of the base portion 182. The tongue 188 allows for extension of the
base portion 182 to
accommodate patients of varying sizes.
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[0132] FIGS. 26 and 27 disclose yet another array structure 190 having a
base portion 192
and a first arm 194 and a second arm 196 extending outward from an end of the
base portion
192. The base portion 192 also includes a tongue 198 slidably engaging the
base portion 192.
However, unlike the embodiment of FIGS. 24 and 25, the tongue 198 utilizes a
sliding
mechanism wherein the tongue 198 is not contained completely within the base
portion 192.
[0133] As shown in FIG. 26, a generally curvilinear cut-out portion 200 is
provided at the
juncture where the arms 194, 196 connect to the base portion 192. This may
provide additional
flexibility allowing for easier adjustment of the arms.
[0134] FIGS. 28 and 29 disclose a further embodiment of an array structure
202 having a
base portion 204 and a first arm 206 and a second arm 208 extending outward
from an end of the
base portion 204. The base portion 204 includes a tongue 210 that is slideable
within an upper
portion of the base portion 204. Notably, the arms 206, 208 have a greater
degree of curvature
than other embodiments shown in the Figures.
[0135] Each arm 206, 208 include a hook segment 212 or other similar
connector extending
outward from the arm. The hook segment 212 is provided for connection to a
necklace
attachment 214 made from a soft thermoplastic rubber or other similar or
suitable material. The
necklace attachment includes a plurality of spaced apart beads 216 (e.g.,
approximately 0.8
inches apart) that can be used to adjustably hold the array in place as shown.
In place of the
beads 216, other configurations (e.g., loops) can be used to adjust the
necklace.
[0136] FIGS 30A- 30X depict six different embodiments of a sensor pad, as
shown from a
top profile, side-cut out profile, side profile, and a top perspective view.
Each of the six designs
is shown in each of the four different views along a row. All drawings in a
column are oriented
the same. FIGS. 30A, 3QG, 30M, and 30S depict a sensor pad having a
semicircular groove
wherein the concave side 402 opens to the rear side 403 and the convex side
401 of the groove is
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on the top side 404. Depicted on the top side 404 of the pad are a plurality
of extension nodules
301. The rear portion of the pad therefore, would contact with the
piezoelectric sensor and the
top side would be open to the air for contacting another surface, such as a
patient. The top view
in FIGS. A-F depicts some of the features of each of the embodiments. Wherein,
the second
column 30G ¨ 30L depict the side-cut out profile, to depict the size and
length of raised or
recessed features, and the grooves around the circumference. The side profile
in the next column
30S-30X shows the relative height of the various features as compared to the
circumferential
groove, and the perspective views 30S-30X depict the embodiments and show
additional detail
of the raised and recessed portions of the sensor pads.
101371 FIGS. 30B, 30H, 30N, and 30T depict a further sensor pad embodiment
comprising a
central extension ring 304 and two further extension rings, 303 and 302 that
protrude slightly on
the top side 404 of the sensor pad. Similarly, FIGS. 30C, 301, 300, and 30U
depict a sensor pad
having a single extension ring 305 and an opening, in place of the extension
rings 304 and 303
from the prior embodiment.
101381 FIGS. 30D, 30J, 30P, and 30V depict a further sensor pad embodiment
comprising a
single raised feature 306 having a filled in central portion 307 that is
slightly concave, as
depicted in 30J. In comparison FIGS. 30E, 30K, 30Q, and 30W depict a single
raised feature
306 and a central portion 308 that is slightly convex as depicted in FIG. 30K.
Then FIGS. 30F,
30L, 30R, and 30X depict a single raised feature 306 and a central portion 309
that is flat, as
depicted in FIG. 30L.
[0139] FIGS. 31A-31T depict 5 embodiments (one in each row starting with
31A-31B)
depicting a top plan view, a side cut-out profile, a side profile, and a
perspective view. All
drawings in a column are oriented the same. FIGS. 31A, 30F, 31K, and 31P
depict a sensor pad
embodiment having a central raised conical like feature 310. Similarly, FIGS.
31B, 31G, 3 IL,
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and 31Q depict a sensor pad embodiment having a single raised spherical
component 311,
wherein the spherical component 311 extends to just about the interior edge of
the concave
portion of the groove 401. FIGS. 31C, 31H 31M, and 31R, by contrast, depict a
similar spherical
like component 313, but having a larger void space 312 between the edge of the
spherical
component 313 and the interior edge of the concave portion of the groove 401.
[0140] FIGS. 31D, 311, 31N, and 31S, depicts an embodiment having three pie
shaped
features 314, each taking up about 120 degrees of the circular shaped sensor
pad. In comparison,
FIGS. 31E, 31J, 310, and 31T depict an embodiment having four pie shaped
features 315,
wherein each pie is about 90 degrees, instead of about 120 degrees.
[0141] FIGS. 32A-32BB depict seven embodiments of a sensor pad wherein each
of four
views of a single embodiment are depicted along a row. All drawings in a
column are oriented
the same. In comparison to the embodiments in FIGS 30 and 31, those in FIG. 32
do not contain
a semicircular groove around the circumference of the sensor pad. FIGS 32A,
32H, 320, and
32V depict four 90 degree pie shaped features 316. FIGS. 32B, 321, 32P, and
32W depict a
plurality of raised nodules 317. FIGS. 32C, 32J, 32Q, and 32X depict three
concentric rings,
320, 319, and 318. FIGS. 32D, 32K, 32R, and 32Y depict a single ring 321 and
an empty space
in place of rings 320 and 319 from the prior embodiment.
[01421 FIGS. 32E, 32L, 32S, and 32Z depict a single raised feature 322
having a filled in
central portion 323 that is slightly concave, as depicted in 30L. In
comparison FIGS. 32F, 32M,
32T, and 32AA depict a single raised feature 322 and a central portion 324
that is slightly convex
as depicted in FIG. 30M. Then FIGS. 32G, 32N, 32U, and 32BB depict a single
raised feature
322and a central portion 325 that is flat, as depicted in FIG. 32N.
101431 FIGS. 33A - 33BB also depict seven embodiments, and four views of
each of the
seven embodiments along a row. All drawings in a column are oriented the same.
FIGS. 33A,
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33H, 330, and 33V depict a single ring 321 and disposed of inside the single
ring 321 is a small
spherical component 326. FIGS. 33B, 331, 33P, and 33W depict a sensor pad
having an angled
face 327. FIGS. 33C, 33J, 33Q, and 33X depict a sensor pad having a top face
328 and curving
to a bottom face 330 with an inflection point 329 disposed of along the curved
face. FIGS. 33D,
33K, 33R, and 33Y, like FIG. 33B, has an angled face, but the face of the
angled component 331
is bulbous, instead of flat like feature 327.
[0144] FIGS. 33E,
33L, 33S, and 33Z depict an embodiment having a raised rim 332 and
extending centrally out from the edge, and containing a central angular peaked
tip 333. FIGS.
33F, 33M, 33T, and 33AA depict a raised edge extending centrally out from the
edge to a point
334. FIGS. 33G, 33N, 33U, and 33BB depict a sensor pad having three pie shaped
components
335, each taking up about 120 degrees of a circle, wherein the pie shaped
components 335 are
raised and having a space between each component.
[0145] FIGS. 34A-
34X depict six sensor pad embodiments and four views of each of the
six embodiments along a row. All drawings in a column are oriented the same,
and features 406
and 405, can be referred to generally as the top side and bottom side, when
looking at side
profiles. FIGS. 34A, 34G, 34M, and 34S depict a single donut or ring shaped
pad, having a flat
bottom surface and rounded top surface. FIGS. 34B, 34H, 34N, and 34T depict an
ellipsis
shaped sensor pad 337, with the top surface 406 being rounded 338 and the
bottom surface 405
being flat. FIGS. 34C, 341, 340, and 34U depict an embodiment having a
circular shape with the
top surface being rounded and the bottom surface flat. FIGS. 34D, 34J, 34P,
and 34V depict an
embodiment having a dodecahedron shape 339, and having three rows of facets
that converge
and taper to a point at the center of the pad. FIGS. 34E, 34K, 34Q and 34W
depict a
semicircular shaped pad 340 having a hollow center as depicted in 34K. FIG.
34F, 34L, 34R,
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and 34X, depicts a semicircular shaped pad 341, but does not have a hollow
center like the prior
embodiment in 34K.
101461 FIGS. 35A - 35T depict five embodiments of sensor pads depicted in
four views of
each of the five embodiments along a row. All drawings in a column are
oriented the same.
FIGS. 35A, 35F, 35K, and 3W depict a hexagonal shaped pad 342 having a
slightly rounded top
and a flat bottom. FIGS. 35N, 35G, 35L, and 35Q depict a triangular shaped pad
343, having a
slightly rounded sides, a slightly rounded top 406, and flat bottom 405. FIGS.
35C, 35H. 35M,
and 35R, by comparison, also depicts a triangular shaped pad 344, but wherein
the sides are
straight and not rounded. FIGS. 35D, 351, 35N, and 35S depicts a square shaped
pad 345,
having slightly rounded sides and top; whereas FIGS. 35E, 35J. 350, and 35T
depict a square
shaped pad 346 having straight sides.
101471 FIGS. 36A - 36T depict five embodiments of sensor pads depicted in
four views of
each of the five embodiments along a row. All drawings in a column are
oriented the same.
FIGS. 36A, 36F, 36K, and 36P depict a six pronged star shaped feature 347,
with each prong
opposing another prong, and the angle between each prong being about 60
degrees. The prongs
have a slightly rounded top and the base on the pad is a flat bottom. FIGS.
36B, 36G, 36L, and
36Q depict a crescent shaped pad 348 having a slightly rounded top 406 and a
flat bottom 405.
FIGS. 36C, 36H, 36M, and 36R depict an oval or stadium shaped pad 349 having
rounded ends
and flat sides to the oval shape. The top is slightly rounded and the bottom
is flat. FIGS. 36D,
361, 36N, and 36S depict an ellipsis shaped pad 350 having a slightly rounded
top and a flat
bottom. FIGS. 36E, 36J, 360, and 36T depict a hexagonal shaped pad 351, having
slightly
rounded sides and a slightly rounded top with a flat base.
101481 FIGS. 37A - 37T depict five embodiments of sensor pads depicted in
four views of
each of the five embodiments along a row. All drawings in a column are
oriented the same.
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FIGS. 37A, 37F, 37K, and 37P depict a caterpillar shaped feature having three
rounded
components 352, 353, and 354, connecting to a larger rounded feature 355 with
the four
combined in a crescent-like shape, wherein the tops are slightly rounded, and
the bottom flat.
FIGS. 37B, 37G, 37L, and 37Q depict a "paw-print" shaped feature situated on a
circular flat
disk, having three set off "toes" 356 that are cylindrical in shape, and a
single semicircular pad
357; wherein each of the top sides are slightly rounded and the bottom is
flat. FIGS. 37C, 37H,
37M, and 37F depict a rounded circular disk base having a larger 359 raised,
circular, angular
feature, and smaller, raised, circular, angled feature, wherein the peak of
the features are adjacent
and sloping away from one another. FIGS. 37D, 371, 37N, and 37S depict six
oval shaped raised
features 360 on a rounded circular disk base, wherein the six oval shaped
raised features 360 are
arranged in a pinwheel-like orientation leaving a central space. FIGS. 37E,
371, 370, and 37T
depict a six-pronged star shape 361, having an angled taper, such that the
central point 362 is
higher than the edge of the arms.
[0149] In certain preferred embodiments, the sensor pads can be secured
onto the
piezoelectric unit via an adhesive, such as one of several common low tack
adhesives for
providing for a temporary securing of the sensor pad to the peizo element.
Other embodiments
may utilize a gel or other water or solvent based material that may secure the
sensor pads without
the need for an additional adhesive material. In further embodiments, the
sensor pad fits into the
sensor pod and secures onto the piezo without the need for any adhesive.
[0150] A particular feature of the sensor pads described in the embodiments
herein is the
fact that the top face shape (that contacts the patient), and the bottom face
shape (that contacts
the piezo) are made so that when the top face contacts the patient and thus
applies pressure to the
sensor pad and through to the bottom face, the shape of both the top face and
the bottom face are
designed so that the piezo does not flex when pressure is applied to the
sensor pad. This is
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important to ensuring consistency and accuracy of the piezo device. Therefore,
the sensor pad, in
certain embodiments is designed such that the piezo does not flex when
pressure is applied to the
sensor pad. In a further preferred embodiment, the piezo flexes less than
about 0.1%, 0.5%,
1.0%, 5.0%, 20%, and 25% and all percentages in between. Accordingly, in
certain
embodiments, the amount of flex is greater than zero (i.e. rigid and does not
flex), but the
amount of flex is minimized to maintain accuracy of the piezoelectric unit.
[0151] It is also preferred that the sensor pads create a proper impedance
matching with a
patient. Accordingly, the sensor pad is designed to have a slight tackiness
which ensures a
proper impedance matching with the patient, which then successfully transfers
sounds through to
the piezo element so that the peizo can properly detect vibrations and noise
signals from the
patient.
[0152] While a touch panel PC is a preferred computing unit, any computer
or computing
system capable of running and displaying the processes described herein can be
utilized with the
components discussed. Additionally, both wired and/or wireless technology may
be utilized with
certain of the components of the system. Other components may require a
shielded cable to
avoid interference in the signal being transmitted. Many modifications and
variations of the
present invention are possible in light of the above teachings.
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