U.S. patent application number 17/659713 was filed with the patent office on 2022-08-18 for attachable sensing pod comprising a piezoelectric unit.
The applicant listed for this patent is CVR Global, Inc.. Invention is credited to Peter Bakema, Bret Kline.
Application Number | 20220257188 17/659713 |
Document ID | / |
Family ID | 1000006272560 |
Filed Date | 2022-08-18 |
United States Patent
Application |
20220257188 |
Kind Code |
A1 |
Kline; Bret ; et
al. |
August 18, 2022 |
ATTACHABLE SENSING POD COMPRISING A PIEZOELECTRIC UNIT
Abstract
A sensor pod assembly comprising a gel pad, a gel pad cap, a
piezoelectric sensor, a base plate, a base plate support, a wiring
harness, a battery, a noise attenuating backing, and a charging
component; said gel pad comprising a top and bottom, said bottom
having a flat bottom and a concave recess; said flat bottom
acoustically contacting said piezoelectric sensor; said
piezoelectric sensor secured to a first side of said base plate
support and a second side of said base plate support secured to
said base plate, a wiring harness and a battery connected to said
base plate, and a charging component having exposed annular rings
on an exterior side of said sensor pod assembly; a noise
attenuating backing compressing the charging component against the
base plate; and a gel pad cap having outer and inner faces, said
inner face in contact with said base plate support.
Inventors: |
Kline; Bret; (Columbus,
OH) ; Bakema; Peter; (Denver, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CVR Global, Inc. |
Denver |
NC |
US |
|
|
Family ID: |
1000006272560 |
Appl. No.: |
17/659713 |
Filed: |
April 19, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16469262 |
Jun 13, 2019 |
11311238 |
|
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PCT/US2017/066329 |
Dec 14, 2017 |
|
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17659713 |
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62434042 |
Dec 14, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01H 11/08 20130101;
A61B 5/6804 20130101; A61B 7/04 20130101; B06B 1/0603 20130101;
H04R 17/02 20130101; A61B 5/02007 20130101; A61B 5/681 20130101;
H04R 1/46 20130101; H04R 1/42 20130101; A61B 5/02416 20130101; H04R
1/04 20130101; A61B 5/6832 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/02 20060101 A61B005/02; A61B 7/04 20060101
A61B007/04; G01H 11/08 20060101 G01H011/08; H04R 1/04 20060101
H04R001/04; H04R 1/42 20060101 H04R001/42; H04R 1/46 20060101
H04R001/46; H04R 17/02 20060101 H04R017/02 |
Claims
1. A sensor pod assembly comprising: a base plate; an electronic
circuitry; a piezoelectric device; a gel pad and a gel pad cap;
wherein attached to the base plate is the electronic circuitry,
including a battery, a wireless connection device, and memory
suitable to electronically run the sensor pod assembly; a retaining
element positioned on the base plate and a piezoelectric unit
positioned on the retaining element; a gel pad having a
piezoelectric device contacting surface and a skin facing surface;
wherein the piezoelectric device contacting surface is in contact
with a first side of the piezoelectric device; and a gel pad cap
attached to the base plate with corresponding threaded components
on the base plate and the gel pad cap so as to secure the gel pad
into place.
2. The sensor pod assembly of claim 1 wherein the retaining element
is an O-ring.
3. The sensor pod assembly of claim 1 wherein the gel pad cap is
constructed having a sound attenuating material disposed within a
shell.
4. The sensor pod assembly of claim 1 wherein a sound attenuating
material is further disposed of between the base plate and the
piezoelectric device.
5. The sensor pod assembly of claim 1 wherein a sound attenuating
material is further disposed of between the piezoelectric device
and the gel pad cap.
6. The sensor pod assembly of claim 1 wherein the gel pad and the
gel pad cap are a single disposable unit, wherein the gel pad is
attached to the gel pad cap.
7. The sensor pod assembly of claim 1 wherein the gel pad comprises
an adhesive on the skin facing surface.
8. A sensor pod assembly comprising: a base plate having a top side
and a bottom side, a piezoelectric unit, a battery, a noise
attenuating backing, a wireless charging coil, a sound attenuating
cap, and a sensor pad, said base plate comprising electronic
circuity connected to said battery, said piezoelectric unit, and
said wireless charging coil, said piezoelectric unit attached to
said top side of said base plate and said wireless charging coil,
and said battery attached to said bottom side; said sound
attenuating cap having a ring shape, having an inner side wall and
an outer side wall and a circular opening providing access to the
piezoelectric unit from the top side; said noise attenuating
backing engaged to the bottom side of the base plate; and said
sensor pad positioned within the circular opening of said sound
attenuating cap and in contact with at least a portion of the
piezoelectric unit.
9. The sensor pod assembly of claim 8 further comprising a base
plate support having a top and a bottom, said bottom of the base
plate support engaged to the top side of the base plate and said
piezoelectric unit attaching directly to the top of the base plate
support.
10. The sensor pod assembly of claim 9 wherein said base plate
support further comprises a securing ridge corresponding to a tab
on said noise attenuating backing.
11. The sensor pod assembly of claim 9 wherein said sound
attenuating cap comprises a securing component on an inner side
having a paired securing component on said base plate support for
selective attachment thereto.
12. The sensor pod assembly of claim 8 further comprising a sound
attenuating material defined between the bottom side of the base
plate and said noise attenuating backing.
13. The sensor pod assembly of claim 9 comprising an adhesive
contact between said piezoelectric unit and said base plate
support.
14. The sensor pod assembly of claim 8 wherein said wireless
charging coil comprises a positive charging contact and a negative
charging contact sandwiched around an insulating spacer.
15. A sensor pod assembly comprising: a gel pad, a gel pad cap, a
piezoelectric sensor, a base plate, a base plate support, a wiring
harness, a battery, a noise attenuating backing, and a charging
component; said gel pad comprising a top and a bottom, said bottom
having a flat bottom and a circumferential flange and said top
having a concave recess; said flat bottom acoustically contacting
said piezoelectric sensor; said piezoelectric sensor secured to a
first side of said base plate support, and a second side of said
base plate support secured to said base plate, a wiring harness and
a battery connected to said base plate, and a charging component
having exposed annular rings on an exterior side of said sensor pod
assembly; a noise attenuating backing compressing the charging
component against the base plate; and a gel pad cap having an outer
face and an inner face, said inner face in contact with said base
plate support.
16. The sensor pod assembly of claim 15 wherein said charging
component comprises a negative annular ring having a negative
contact point, a spacer, and a positive annular ring having a
positive contact point, wherein the negative annular ring and
positive annular ring sandwich the spacer.
17. The sensor pod assembly of claim 16 wherein said negative
annular ring and said positive annular ring are connected to said
wiring harness.
18. The sensor pod assembly of claim 15 further comprising a sound
attenuating material disposed of between said base plate and said
noise attenuating backing.
19. The sensor pod assembly of claim 15 wherein said gel pad cap
comprises threads on the inner face corresponding to threads on a
portion of the base plate support, said threads provided for
selective attachment of the gel pad cap to said base plate support.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/469,262 filed on Jun. 13, 2019, which is a
371 National Phase Entry of International Patent Application No.
PCT/US2017/066329 filed Dec. 14, 2017, which claims the benefit of
U.S. Provisional Patent Application No. 62/434,042 filed on Dec.
14, 2016, the contents of which are incorporated herein by
reference in their entirety.
FIELD OF INVENTION
[0002] The present application is generally related to an
attachable sensor pod that can be selectively attached to a patient
for detecting certain vortices in the body, wherein said attachable
sensor pod comprises a piezoelectric component that is utilized to
detect, measure, and record certain vortices in the body so as to
determine stenosis in the arterial system.
BACKGROUND OF THE INVENTION
[0003] US 2012-0232427 describes a sensor, sensor pad and sensor
array for detecting infrasonic acoustic signals. The '427
application generally describes several sensor pods and
particularly the use of a piezo electric unit to detect infrasonic
acoustic signals from a body.
[0004] Piezoelectric units function based on the occurrence of
electric depose moments in solids. The solid may be either induced
for ions on crystal lattice sites with asymmetric charge
surroundings or may directly be carried by molecular groups. The
dipole density or polarization may be calculated by summing up the
dipole moment per volume of the crystallographic unit cell.
[0005] Piezoelectric sensors (also referred to as a "Piezo") have a
variety of potential uses, but as described herein, they are being
utilized as a microphone. The principal of operation of a
piezoelectric sensor is that a physical dimension, transformed into
a force, acts on two opposing faces of the sensing element.
Detection of pressure variations in the form of sound is the most
common sensor application, e.g., acting as a microphone, wherein
the sound waves bend the piezoelectric material creating changing
voltage. Accordingly, the piezo sensor can be placed on or near a
sound to receive the sounds.
[0006] Piezo sensors are especially used with high frequency sound
in ultrasonic transducers for medical imaging and industrial
nondestructive testing. However, piezo sensors are also frequently
used for the detection and activation of a device, based on the
ability to receive a signal and to then send an electronic signal,
thereby acting as the actuator.
SUMMARY OF THE INVENTION
[0007] A sensor pod assembly comprising: a base plate; an
electronic circuitry; a piezoelectric device; a pair of O-rings; a
gel pad and a gel pad cap; wherein attached to the base plate is
the electronic circuitry, including a battery, a wireless
connection device, and memory suitable to electronically run the
sensor pod; the first O-ring of the pair of O-rings is positioned
on the base plate and a piezoelectric unit is positioned on the
O-ring; the second O-ring of the pair of O-rings is positioned
above the piezoelectric unit so as to sandwich the piezoelectric
unit between the pair of O-rings; a gel pad having a piezo
contacting surface and a skin facing surface; wherein the piezo
contacting surface is in contact with a first side of the piezo
electric unit; and a gel pad cap attached to the base plate with
corresponding threaded components on the base plate and the gel pad
cap, so as to secure the gel pad into place.
[0008] The sensor pod wherein the gel pad cap is constructed having
a sound attenuating material disposed within a shell.
[0009] The sensor pod wherein a sound attenuating material is
further disposed of within the circumference of the O-rings and
between the base plate and the piezo electric unit.
[0010] The sensor pod wherein a sound attenuating material is
further disposed of between the O-rings and the gel pad cap.
[0011] The sensor pod wherein the gel pad and the gel pad cap are a
single disposable unit, wherein the gel pad is attached to the gel
pad cap.
[0012] The sensor pod wherein the gel pad comprises an adhesive on
the skin facing surface.
[0013] A sensor pod assembly comprising: a base plate; an
electronic circuitry; a piezoelectric device; a pair of O-rings; a
gel pad and a gel pad cap; wherein attached to the base plate is
the electronic circuitry, including a battery, a wireless
connection device, and memory suitable to electronically run the
sensor pod; the first O-ring of the pair of O-rings is positioned
on the base plate and a piezoelectric unit is positioned on the
O-ring; the second O-ring of the pair of O-rings is positioned
above the piezoelectric unit so as to sandwich the piezoelectric
unit between the pair of O-rings; a gel pad having a piezo
contacting surface and a skin facing surface; wherein the piezo
contacting surface is in contact with a first side of the piezo
electric unit; and a gel pad cap attached to the base plate with
corresponding threaded components on the base plate and the gel pad
cap, so as to secure the gel pad into place.
[0014] In a preferred embodiment, the gel pad cap is constructed
having a sound attenuating material disposed within a shell.
[0015] In a preferred embodiment, wherein a sound attenuating
material is further disposed of with the circumference of the
O-rings and between the base plate and the piezo electric unit.
[0016] In a further embodiment, wherein a sound attenuating
material is further disposed of between the O-rings and the gel pad
cap.
[0017] In a further embodiment, wherein the gel pad and the gel pad
cap are a single disposable unit, wherein the gel pad is attached
to the gel pad cap.
[0018] In a further embodiment, wherein the gel pad comprises an
adhesive on the skin facing surface.
[0019] In a further embodiment, a sensor pod assembly comprising: a
base plate having a top side and a bottom side, a piezoelectric
unit, a battery, a noise attenuating backing, a wireless charging
coil, a sound attenuating cap, and a sensor pad, said base plate
comprising electronic circuity connected to said battery, said
piezoelectric unit and to said wireless charging coil, said
piezoelectric unit attached to said top side of said base plate and
said wireless charging coil and said battery attached to said
bottom side; said sound attenuating cap having a ring shape, having
an inner and outer side wall and a circular opening providing
access to the piezoelectric unit from the top side; and said noise
attenuating backing engaged to the bottom side of the base plate;
and said sensor pad positioned within the circular opening of said
sound attenuating cap and in contact with at least a portion of the
piezoelectric unit.
[0020] In a further embodiment, the sensor pod assembly further
comprising a base plate support having a top and a bottom said base
plate support bottom engaged to the top side of the base plate and
said piezo attaching directly to the base plate support top.
[0021] In a further embodiment, the sensor pod assembly wherein
said base plate support further comprises a securing ridge
corresponding to a tab on said noise attenuating backing.
[0022] In a further embodiment, the sensor pod assembly wherein
said sound attenuating cap comprises a securing component on an
inner side having a paired securing component on said base plate
support for selective attachment thereto.
[0023] In a further embodiment, the sensor pod assembly further
comprising a sound attenuating material defined between the base
plate bottom and said noise attenuating backing.
[0024] In a further embodiment, the sensor pod assembly comprising
an adhesive contact between said piezoelectric assembly and said
base plate support.
[0025] In a further embodiment, the sensor pod assembly wherein
said wireless charging coil comprising a positive charging contact
and a negative charging contact sandwiched around an insulating
spacer.
[0026] A sensor pod assembly comprising: a base plate having a top
and a bottom face; a base plate support having a top and bottom, an
electronic circuitry; a piezoelectric device having a first side
and a second side; a gel pad and a gel pad cap; wherein attached to
the base plate is the electronic circuitry, including a battery, a
wireless connection device, and memory suitable to electronically
run the sensor pod; said bottom of the base plate support attached
to the top face of the base plate, and said second side of said
piezoelectric device attached to the top of the base plate support,
a gel pad having a piezo contacting surface and a skin facing
surface; wherein the piezo contacting surface is in contact with a
first side of the piezo electric unit; and a gel pad cap comprising
an outer layer and an inner layer, with said inner layer attached
to the base plate with corresponding threaded components on the
base plate and the inner layer of said gel pad cap.
[0027] In a further embodiment, the sensor pod assembly wherein
said gel pad comprises a circumferential flange on the piezo
contacting surface, said circumferential flange in intimate contact
with said gel pad cap, thereby securing said gel pad into
position.
[0028] In a further embodiment, a sensor pod assembly comprising a
sensor pad, a sensor pad cap, a piezoelectric unit, a base plate, a
base plate support, a battery, electronic circuitry, a sound
attenuating material, a wireless charging coil, and noise
attenuating backing; said base plate having a top side and a bottom
side, said top side in intimate contact with a bottom side of said
base plate support; a piezoelectric device attached to a top side
of said base plate support; said sensor pad cap contacting a top
side of said base plate support, outside of said piezoelectric
device, and defining therebetween said base plate support and said
sensor pad cap, a void filled with said sound attenuating material;
said battery attached to said bottom side of said base plate and
electronic circuitry connecting said battery and said piezo to said
base plate, and said wireless charging coil secured to the bottom
side of said base plate, with said noise attenuating backing
defining a rear of said assembly.
[0029] In a further embodiment, a sensor pod assembly comprising a
gel pad, a gel pad cap, a piezoelectric sensor, a base plate, a
base plate support, a wiring harness, a battery, a noise
attenuating backing, and a charging component; said gel pad
comprising a top and bottom, said bottom having a flat bottom and a
circumferential flange and said top having a concave recess; said
flat bottom acoustically contacting said piezoelectric sensor; said
piezoelectric sensor secured to a first side of said base plate
support, and a second side of said base plate support secured to
said base plate, a wiring harness and a battery connected to said
base plate, and a charging component having exposed annular rings
on the exterior side of said sensor pod assembly; a noise
attenuating backing compressing the charging component against the
base plate; and a gel pad cap having an outer face and an inner
face, said inner face in contact with said base plate support.
[0030] In a further embodiment, the sensor pod assembly wherein
said charging component comprises a first negative annular ring
having a negative contact point, a spacer, and a positive annular
ring having a positive contact point, wherein the negative annular
ring and positive annular ring sandwich the spacer.
[0031] In a further embodiment, the sensor pod assembly wherein
said negative annular ring and said positive annular ring are
connected to said wiring harness.
[0032] In a further embodiment, the sensor pod assembly further
comprising a sound attenuating material disposed of between said
base plate and said noise attenuating backing.
[0033] In a further embodiment, the sensor pod assembly wherein
said gel pad cap comprises threads on the interior face
corresponding to threads on a portion of the base plate support,
said threads providing for selective attachment of the gel pad cap
to said base plate support.
[0034] A further embodiment is directed toward a method of
determining stenosis comprising adhering a sensor pod to a patient
and detecting sounds from a target artery, and determining stenosis
based upon the detected sounds.
BRIEF DESCRIPTION OF THE FIGURES
[0035] FIG. 1 depicts a sensor pod and attached gel pad.
[0036] FIGS. 2A and 2B depict two variants of gel pads for
selective attachment to a sensor pod having an adhesive
thereon.
[0037] FIG. 3 depicts a cross-sectional view of a gel pad having an
adhesive placed on the entire face.
[0038] FIG. 4 depicts a cross sectional view of a sensor pod.
[0039] FIG. 5 depicts a cut out of a portion of the sensor pod and
gel pad.
[0040] FIGS. 6A, 6B, and 6C depict components of a sensor pod,
wherein FIG. 6A depicts a front (patient) view of an alternate,
contact charging sensor pod design and attached gel pad, FIG. 6B
depicts a side view of an alternate, contact charging sensor pod
design and attached gel pad, and FIG. 6C depicts a rear view of an
alternate, contact charging sensor pod design and attached gel
pad.
[0041] FIGS. 7A and 7B depict an isometric view of an alternate,
contact charging sensor pod design with FIG. 7A depicting an
attached gel pad and FIG. 7B depicting the charging sensor pod
design and unattached gel pad or partially exploded view.
[0042] FIG. 8 depicts an exploded isometric view of an alternate,
contact charging sensor pod design, its internal parts, and an
unattached gel pad.
[0043] FIGS. 9A and 9B depict and alternative contact charging
sensor pod design, with FIG. 9A depicting a front (patient facing
side) view and FIG. 9B depicting a cross section through the gel
pad based on the section line in FIG. 9A.
[0044] FIGS. 10A and 10B depict a further alternative assembly,
with FIG. 10A depicting a front (patient facing side) view of an
alternate, contact charging sensor pod design and attached gel pad
with a section line, and FIG. 10B depicting a cross section through
the attached gel pad based on the section line in FIG. 10A.
DETAILED DESCRIPTION OF THE INVENTION
[0045] Piezoelectric sensors are highly sensitive detection devices
that can be utilized to detect and record sounds at a huge range of
frequencies and amplitudes. In certain devices, piezoelectric
sensors can be utilized for detecting even the faintest sounds,
which can then be recorded and analyzed for understanding of
internal flow patterns in the arterial system. However, because of
the low amplitude sounds that are being detected, any ambient
noises or background noise can be fatal to accurately detecting and
measuring the faint noises. Indeed, the ambient noises are
sufficiently loud in most cases that they can irretrievably
entangle the subtle noises for detection. In a sense, the noises to
be detected become so small as to be lost.
[0046] The device described herein is a sensor pod having a
piezoelectric unit that is part of a larger system or device for
detecting and measuring vortices in the body, specifically in the
arterial blood flow systems, wherein the sounds are detected,
stored and can be analyzed to determine blockage in the arterial
system.
[0047] Because of the highly sensitive nature of the piezoelectric
units, having the pod attached to any number of components may
introduce background noise error. Accordingly, in certain
embodiments as described herein provides for a sensor pod that is
adhered to the skin of a patient for detecting the sounds through
the arterial system and transmits the sound data wireless via
Bluetooth, WiFi, or similar wireless network(s) to a receiving
device capable of recording and interpreting the sent data.
Additionally, the sensor pod is powered via a built-in rechargeable
battery that may be recharged wirelessly or via metal to metal
contacts. This provides an opportunity to eliminate the use of a
holding device that may introduce noise to the piezo. Accordingly,
these devices can be directly placed on the body without a holding
device. However, a holding device may be utilized in certain
situations to assist with maintaining the device in a defined
position.
[0048] The sensor pods are depicted in greater detail in the
figures. FIG. 1 depicts a sensor pod (32) having an attached gel
pad (10). The sensor pod (32) is circular in shape and has a pad
cap (34). The pad cap (34) has several functions. First, it is
intended to assist in holding the gel pad (10) to the piezoelectric
unit (not depicted in FIG. 1). It aligns the gel pad (10) to the
center of the piezoelectric unit (not depicted in FIG. 1). The pod
cap (34) preferably screws onto the sensor pod (32), though other
attachment mechanisms are suitable. In certain embodiments, for
example, the pod cap (34) can compress and retain an edge of the
gel pad (10) to hold it in place. In other embodiments, the pod cap
(34) can simply reduce movement of the gel pad (10), where it is
maintained on the piezoelectric unit with friction or an adhesive
force between the piezoelectric unit and the gel pad (10)
itself.
[0049] The gel pads (10) optionally comprise an adhesive (100)
(such as a pressure sensitive adhesive) that is placed on one more
of the skin facing side of the gel pad (10). The adhesive is
utilized to adhere the gel pad to the skin surface of a patient.
The adhesive can then be selectively removed from the skin surface
and thus remove the gel pad (10) and the sensor pod. The types of
adhesives for such use are available in the medical industry for
numerous components that are necessary to be selectively adhered to
the skin of a patient. Adhesives, for the purposes of this
application, may also include conductivity gels typically
comprising one or more of propylene glycol, glycerin,
phenoxyethanol, and Carbopol polymers.
[0050] FIG. 2 provides additional examples of the adhesive (100)
being placed onto the surface of the gel pad (10). In FIG. 1, the
adhesive (100) is placed on substantially the entire top surface of
the gel pad (10). In FIG. 2A, the gel pad (10) is placed only on
the circular ridge (22) and surfaces, but not inside of the concave
recess (24). By comparison, FIG. 2B depicts the adhesive (100)
placed only inside the concave recess (24) of the gel pad. Certain
gel pads (10) further comprises a circumferential flange (18) that
assists with securing the gel pad (10) underneath the pod cap (34),
as depicted in FIGS. 1 and 4, and against the piezoelectric unit.
Furthermore, the side wall (20) of the gel pad (10) typically does
not need any adhesive, as it will not be in contact with the skin
surface.
[0051] FIG. 3 depicts a variant shape of the gel pad (10) in a
cross-sectional view showing clearly the side wall (20) and the
flange (18). The adhesive (100) is depicted as being provided on
both the top circular ridge (22), and also in the concave recess
(24). The shape of the gel pad (10) in FIG. 3 has a much sharper
transition from the circular ridge (22) to the concave recess (24),
as compared to those depicted in FIGS. 2A and 2B. Other suitable
shaped gel pads are previously disclosed by the applicant and may
be suitable for use herein, in for example U.S. Provisional Patent
Application No. 62/350,617, filed Jun. 15, 2016, or US
2015-0320323. FIG. 3 further depicts the gel material (16) that is
within the concave recess. In certain embodiments the gel pad (10)
is made of a single material typically by molding. However, in
other embodiments, the exterior of the gel pad (10), as identified
by the striped lines, including the gel base (12), the flange (18),
the side walls (20), the circular ridge (22) and the concave recess
(24) are made of one material, typically a thermoformed or
injection molded film, and a second transference material is
injected into the center of the gel pad. This material assists with
acoustical coupling between the skin and the piezoelectric
unit.
[0052] Indeed, the sound properties are paramount in this
invention. A second feature of the pod cap (34), as depicted in
FIGS. 1, 2, and 4 is the ability to limit or reduce background
noise or other sound pollution. Therefore, the pod cap (34) can be
manufactured in a single piece or multi piece solid, cellular, or
filled plastic, metal, or polymer material that can attenuate
sound. However, in other embodiments, the pad cap (34) is
manufactured having a sound attenuating structure in the cap. For
example, FIG. 4 depicts that the pod cap (34) comprises an exterior
shell (46) and an interior sound attenuating material (52). The
exterior shell may be a rigid or compressible material, but should
be easily cleaned for sanitary procedures, as it may, in some cases
contact the skin of the patient.
[0053] The sound attenuating material (52) is depicted having a
different structure than the exterior shell (46). For example, the
structure may be an open or honeycomb like structure to reduce
sound. Furthermore, a foam, gel, or additional material may be
inserted or injected into a hollow portion of either or both of the
exterior shell (46) or of the sound attenuating material (52), so
as to create additional sound attenuating properties.
[0054] However, FIG. 4 further provides several additional features
that are relevant to the sound attenuating properties of the
invention as disclosed herein. For example, there is a void (50)
between the gel pad (10) and the pod cap (34). This void (50) can
be left without material or can be optionally provided with a sound
attenuating material. For example, the gel pad (10) can be inserted
and then a further gel material can be expressed around the side of
the gel pad (10) to create a seal between the pod cap (34) and the
gel pad (10). Otherwise, the void (50) can be simply filled with a
sound attenuating material and connected to the inside lip of the
pod cap (34).
[0055] In one embodiment, mounting of the piezo (40) is provided by
elastomeric, electrically conductive, O-rings (42), to sandwich the
piezoelectric unit (40). These torus structures are provided to
specifically attenuate and separate noise and vibrations from the
device and the piezoelectric unit (40) itself. Therefore, spaces
like void (50) can be appropriately utilized with the necessary
material to attenuate or reduce sound and background noise.
Alternatively, nonconductive O-rings can be utilized where
appropriate for electrically separating the components. Additional
mounting mechanisms for the piezoelectric unit (40) are also
suitable, such as with an adhesive, threaded fastener, or as
otherwise described herein or as known to those of skill in the
art.
[0056] A side cap void (95) is provided adjacent to the
piezoelectric unit. Preferably this is left as a void so as to not
contact any portion of the piezoelectric unit (40). Indeed, the
torus structures as depicted assist in separating the piezoelectric
unit (40) from the rest of the device.
[0057] Below the piezoelectric unit (40) is a sound attenuating
barrier (70). This barrier provides for space between the
piezoelectric unit itself and the base, thereby allowing the
piezoelectric unit to vibrate and function as necessary. However,
the attenuating barrier (70) is positioned on base barrier (56)
made of the same or similar sound attenuating materials as
described for the pad cap (34). Similarly, base void (112) can be
left open or filled with an appropriate material for attenuating
sound.
[0058] On each side of FIG. 4 is a rear barrier (90) that is in
contact with the base barrier (56). This rear barrier (90) is a
ring like structure that surrounds the base and is made of one or
more sound attenuating material. By having a ring like structure,
the rear barrier (90) provides for rear openings (111) that allow
for several options. For example, the circuitry and components
necessary to run the devices. For example, the electronic module
(80) is positioned in this rear opening (111) and provides for the
necessary circuitry to run the device, provide wireless
connectivity features, and provide power, among other features. The
electronic module (80) will include all the necessary features to
run the device. Wires may run from the electronic module (80)
through the wired stem (150) to connect to the piezoelectric unit
(40). Additional wires may connect internal components and wireless
features will then allow for transmission of data from the sensor
pods to a base on control unit.
[0059] The sensor pods are preferably wirelessly charged through
components in the electronic module (80) and a base charging
station. However, suitable wired or contact points may also charge
the internal batteries. Similarly, electronic contact points may
also allow for transmission of data in place of wireless
connectivity, or in addition to wireless connectivity.
[0060] FIG. 5 provides a detailed depiction of a portion of one
section of an embodiment of a sensor pod. For example, as compared
to FIG. 4, a sound base (91) is provided that covers the rear
portion of the base of the sensor pod. This sound base (91) is made
of any number of suitable sound attenuation materials. The primary
goal of the material is to isolate the piezoelectric device inside
the sensor pod.
[0061] In a further embodiment, the pad cap (34) comprises an
exterior shell or film and a hollow internal compartment, as
depicted in FIG. 5. Accordingly, this hollow compartment can be
suitably filled or injected with a sound attenuating material (52).
Thus, the material can be injected after the shell is manufactured
to allow for a great variety of materials that may not be suitable
during the curing process.
[0062] As described above, the sound attenuating material (52) of
the pad cap is depicted in direct contact with the gel pad (10). In
this orientation, the surrounding materials of the sensor pod act
much like a pair of over-the-ear headphones, in that they surround
the area of skin and isolate sounds away from this area.
Accordingly, background noise should be attenuated as much as
reasonably possible to provide for greater clarity of the signal to
improve the signal-to-noise ratio.
[0063] The piezoelectric sensor (piezo) itself is described in the
above reference applications, each of which are incorporated herein
by reference. Generally, piezo sensors have a diameter of 1.5''. A
range of 0.1'' to about 12'' is preferred, wherein the size of the
piezo is related to the diameter of the fluid flow vessel to be
measured. In preferred embodiments, the fluid flow vessels are
veins and arteries in the body, and which a 1.5'' or smaller
diameter piezo is preferable.
[0064] There is no inherent frequency limit for a piezoelectric
sensor. However, the limits of applications are usually determined
by resonances associated with the shape and/or the size of the
transducer design. The piezo sensors utilized herein, have a
thickness of about 0.5 mm and are capable of detecting sounds
between 10 Hz and 32 KHz and an amplitude of 0.0002 N/m.sup.2 to
greater than 10 N/m.sup.2. In preferred embodiments, the piezo
attached to a sensor pod detect sounds between about 20 Hz to 3,000
Hz, which are relevant towards measurements of fluid flow in the
body. Typically, these sounds have an amplitude of between 0.002
N/m.sup.2 and 20 N/m.sup.2. While additional sounds are recorded,
many of these sounds, i.e., the heartbeat and extraneous noise, are
removed from the data set through several filters.
[0065] Indeed, it is known that the piezo elements wear over time
and that damage can unfortunately occur from use. Because of the
sensitive nature of the sensor pods, it is necessary to ensure that
they are properly functioning before each use. Proper testing
protocols utilize a program implemented through a computer, which
generates a known set of sounds related to the sounds to be
detected on the fluid flow vessel and matches the known played
sound to the sounds detected and recorded in realtime by the sensor
pods. Where the known sounds and detected sounds match, the sensor
pod is confirmed to be working. Wherein the sensor pod is not
functioning properly, the system will sound an alarm, which will
indicate to the operator the need to replace the disposable
component of the sensor pod.
[0066] Before the sensor pods are utilized, the piezoelectric
sensors must be tested to confirm that they are functioning as
intended. Because of the sensitive and fragile nature of the
piezoelectric elements, there are several ways in which the
piezoelectric elements can be damaged including ordinary and
standard use of the device. Damage may occur as the piezoelectric
element wears from ordinary and standard use, and after about 50 to
about 400 uses, the piezoelectric element breaks down so that the
function and the electrical currents generated are different when
comparing the first use to the 100th, 200th, 300th, or 400th use.
Accordingly, to ensure that accurate results are received by each
of the units, it is imperative to replace the unit that has worn to
maintain consistent results.
[0067] Additional wear or breakage can occur to the piezoelectric
sensors (40) by rough use of devices. For example, human error may
lead to the devices being dropped, or placed onto a base or
charging station improperly, that results in breaks, bends, or
otherwise damages the piezoelectric unit.
[0068] Further damage may occur as clean sensor pads (10) are
attached and placed against the piezoelectric sensor (40) for use
on a patient. To ensure sanitary use of the device, the sensor pads
(10) are replaced between each use of the device. However, because
the sensor pads (10) are placed directly onto the piezoelectric
unit (40), there is risk that human error may damage the
piezoelectric sensor, either by too much force, or simply through
improper pressure applied to the sensor when installing or removing
a sensor pad (10). However, as described above, some portions of
the pod cap (34) may contact the skin of the patient and thus these
components need to be either able to be sterilized or
replaceable.
[0069] Indeed, in certain embodiments, the gel pad (10) and the pod
cap (34) are a complete disposable unit that is manufactured with
an adhesive on the skin facing side. A removable adhesive barrier
is placed on this surface for transport and sanitary procedures and
is removed before use. The pod cap (34) is thus attached to the gel
pad, e.g., in FIG. 5, they are depicted as in contact, and can be
adhered together at the contact points.
[0070] In certain embodiments, by screwing on the pod cap (34), the
gel pad (10) is properly seated in the device. In certain
embodiments, the flange (18) (as in FIG. 2A and 2B) is in contact
with the underside or interior side wall of the pod cap (sound
attenuating cap). However, in other embodiments, the gel pad (10)
flange (18) does not contact the pod cap (34), and instead is
merely in contact with the top face of the piezo. In other
embodiments, the gel pad (10) does not contain a flange (18).
[0071] A gel or electronic material (6) may be further provided on
the piezoelectric unit to improve impedance measuring in certain
embodiments, or alternatively, to aid in selectively adhering the
gel pad (10) to the piezoelectric unit or to the skin of the
patient. Accordingly, the gel can function as both an acoustic
material as well as an adhesive.
[0072] FIG. 6A depicts a view of the device from the skin facing
side of an alternative embodiment of the device. The gel pad (10)
is depicted with a pattern thereon. FIG. 6B depicts a side view of
the contact charging sensor pod. The side profile depicts a
negative metal contact ring (190). This feature allows the device
to be charged anywhere within 360.degree. around the device. This
allows for simplicity in charging the device as the charging
element can then be placed anywhere around the unit to be charged.
This can be through induction charging or through contact charging,
as appropriate. An insulating spacer (195) separates the contact
rings (190 and 197). Indeed, ring (190) is the negative, while ring
(197) is the positive. At the rear of the device is a rigid rear
cap (210). This cap (210) is shown in detail in FIG. 6C with an
ornamental design provided thereupon. The rear cap (210) provides
noise attenuating features and is referred to in certain cases as a
noise attenuating backing.
[0073] FIG. 7A and 7B depict an alternative view of the contact
charging sensor pod. The charging rings (190 and 197) are depicted
in FIG. 7A, with the gel pad (10) in place. FIG. 7B depicts the
charging pod with the gel pad (10) removed and depicting the
piezoelectric sensor (40) where the gel pad (10) would otherwise
contact.
[0074] FIG. 8 depicts an exploded view of a charging sensor pod.
The sensor pad (10) is depicted on the left most side, with an
adhesive (100) provided therein. The pod cap (34) is depicted with
a thermoplastic elastomer over molded material provided on outer
and inner surfaces of the pod cap (34). The inclusion of the
material herein aids in sound attenuation and soft touch features
so as to eliminate background noise received by the piezoelectric
unit (40). The piezoelectric unit (40) is provided with a flexible
adhesive (165) which bonds the piezoelectric unit (40) to the PCB
support (170). The PCB support (170) is connected to the PCB board
(180). The PCB board (180) includes at least an LED (181), a spring
pin negative (182) and a spring pin positive (183). The negative
pin (182) connects to the metal connector tab (198) on the metal
contact ring (197). The positive spring pin (183) connects to the
connector tab (191) on contact ring (190). These components allow
for simple and efficient contacts between the charging rings and
the various electronic circuitry on the PCB board (180) to allow
the device to function.
[0075] A rechargeable battery (184) is provided so as to power the
device and can be connected to the PCB board (180) or simply
affixed within the openings of the device therein. The insulator
spacer (195) connects the rings (190 and 197) via heat stakes. The
components can be affixed using threaded fasteners (200) or affixed
with other means such as adhesives, welds, plastic, or other means
as known to a person of ordinary skill in the art. The rear cap
(210) includes several snap tabs (211) which connect the rear cap
(210) to the insulator spacer (195) to ensure snug fit but also
access to internal components of the device.
[0076] In certain embodiments, the PCB board (180) (also referred
to as a base plate) is defined as having a top and a bottom. The
top side of the PCB board (180) then contacts to the PCB support
(170). This PCB support (170) (base plate support) contacts
directly to the piezoelectric unit (40) with an adhesive (165). The
PCB support (170) further comprises corresponding latches for
contacting with the snap tabs (211) on the rear support (noise
attenuating backing) (210).
[0077] As defined throughout, sound attenuating materials can be
further secured within open spaces inside this assembly. Indeed,
isolating sound from the piezo ensures that ambient noise and
background noise is limited or eliminated and provides for a
cleaner signal for processing.
[0078] FIG. 9A provides a front or skin facing surface view of the
charging sensor pod. A cross sectional line "A" is provided and
depicted in FIG. 9B. FIG. 9B therefore depicts the gel pad (10),
piezoelectric unit (40), a flexible adhesive (165), a PCB board
(180), negative spring pin (182), connection tab (198), negative
metal contact ring (190), and the insulator spacer (195) on the
righthand side.
[0079] The rear cap (210) may be made of a sound absorbing material
or include a coating or lining of sound attenuating material
disposed of on the inner or outer face of the rear cap (210).
[0080] The battery (184) is provided centrally, while the left side
depicts the positive metal contact (197), with the thermoplastic
outer molded material (160) as a portion of the pod cap (34).
Further provided is the piezoelectric and PCB support (170).
[0081] As is provided in prior figures, there is space or a void
throughout the device that can be further filled with a sound
attenuating material, such as a foam, gel, or other suitable
material to limit background noise received by the piezo.
[0082] FIGS. 10A and 10B further depict an alternative gel pad (10)
design, with the cross-sectional view through the "B" line.
Depicted are an LED (181) and the snap tabs (211) corresponding to
the rear cap (210).
[0083] Therefore, the device provides for a sensor pod that can be
provided as a standalone testing device. The device can be directly
placed onto a patient, and an optional pressure sensitive adhesive
can be utilized to assist in holding the device onto the patient.
Certain embodiments of the gel pad (10) also allow for generation
of small suction forces to assist in holding the device to the skin
of a patient. If, for example, a left artery is being tested, the
patient can lay on the right side, having the left artery facing
up, and then place the sensor pod onto the patient, where an
adhesive and/or suction forces can assist in holding the sensor pod
in position to perform a test.
[0084] In preferred embodiments, the device is used together with
one, two, or three devices placed on the patient. In an orientation
with a single device, the device is placed over an artery or vein
on a patient that is being tested for blockage or stenosis. When
using two devices together, there are two orientations. A first
orientation places one device over the heart and a second over the
area to be studied or tested for stenosis. A second orientation
provides for a first device over one artery and a second device
over a second artery. For example, the devices may be placed over
the left and right carotid arteries, as a nonlimiting example of
the positioning of the devices.
[0085] When using three devices, preferably a first device is
placed over the heart and two additional devices placed over
corresponding arteries on the body. For example, one over the heart
and the second and third devices on the left and right carotid
arteries. However, additional arterial may include the Vertebral
artery, brachiocephalic artery, axillary artery, aorta, abdominal
aorta, superior mesenteric artery, gonadal artery, inferior
mesenteric artery, common iliac artery, external iliac artery,
digital arteries, femoral artery, popliteal artery, anterior tibial
artery, posterior tibial artery, dorsalis pedis, arcuate artery,
subclavian artery, artic arch, coronary artery, thoracic aorta,
gastric artery, splenic artery, hepatic artery, renal artery,
radial artery, ulnar artery, deep palmar arch, superficial palmar
arch, deep femoral artery.
[0086] Accordingly, the devices can be utilized in conjunction with
methods to determine blockage or stenosis in the circulatory system
of a human, by placing the devices on the skin adjacent to the
target artery, wherein the device detects small sounds from the
artery that can be detected by the highly sensitive piezo
component, and wherein algorithms can then determine stenosis at
the target artery.
* * * * *