U.S. patent application number 16/664061 was filed with the patent office on 2021-07-01 for sinus treatment device with enhanced tip.
The applicant listed for this patent is TIVIC HEALTH SYSTEMS INC.. Invention is credited to JOHN CLAUDE, CHRISTOPHER A. WIKLOF.
Application Number | 20210196945 16/664061 |
Document ID | / |
Family ID | 1000005650094 |
Filed Date | 2021-07-01 |
United States Patent
Application |
20210196945 |
Kind Code |
A9 |
CLAUDE; JOHN ; et
al. |
July 1, 2021 |
SINUS TREATMENT DEVICE WITH ENHANCED TIP
Abstract
A sinus treatment device and methods of operating the sinus
treatment device that include an enhanced conductive tip and at
least one return electrode are disclosed.
Inventors: |
CLAUDE; JOHN; (REDWOOD CITY,
CA) ; WIKLOF; CHRISTOPHER A.; (EVERETT, WA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
TIVIC HEALTH SYSTEMS INC. |
Menlo Park |
CA |
US |
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Prior
Publication: |
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Document Identifier |
Publication Date |
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US 20200164202 A1 |
May 28, 2020 |
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Family ID: |
1000005650094 |
Appl. No.: |
16/664061 |
Filed: |
October 25, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2018/029030 |
Apr 24, 2018 |
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16664061 |
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62491793 |
Apr 28, 2017 |
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62559792 |
Sep 18, 2017 |
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62560120 |
Sep 18, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36031 20170801;
A61N 1/0456 20130101 |
International
Class: |
A61N 1/04 20060101
A61N001/04; A61N 1/36 20060101 A61N001/36 |
Claims
1.-48. (canceled)
49. A method, comprising: detecting an impedance level through a
user body between a conductive tip of a sinus treatment device and
a return electrode of the sinus treatment device; initiating a
treatment mode of the sinus treatment device when the impedance
level through a user body drops below a threshold by passing a
sinus treatment current level through a user body between the
conductive tip and the return electrode; and gradually increasing a
magnitude of the sinus treatment current during the treatment
mode.
50. The method of claim 49, wherein the sinus treatment current
includes a series of current spikes.
51. The method of claim 50, wherein gradually increasing the
magnitude of the sinus treatment current includes gradually
increasing an amplitude of successive current spikes, and further
comprising ceasing increasing the magnitude of the sinus treatment
current when the current spikes reach a predetermined treatment
level.
52. (canceled)
53. The method of claim 51, wherein after reaching the
predetermined treatment level, subsequent current spikes each have
a magnitude substantially equal to the predetermined treatment
level.
54. The method of claim 50, wherein the current spikes have a peak
magnitude of less than 1000 .mu.A.
55. The method of claim 54, wherein the current spikes have a peak
magnitude of less than 600 .mu.A.
56. The method of claim 50, wherein the current spikes have an
average value less than 1000 .mu.A.
57. The method of claim 56, wherein the current spikes have an
average value less than 600 .mu.A.
58. The method of claim 50, wherein the current spikes alternate
between positive and negative values.
59. The method of claim 58, wherein the current spikes alternate at
a frequency less than 1000 Hz.
60. The method of claim 59, wherein the current spikes alternate at
a frequency between 1 Hz and 100 Hz.
61. The method of claim 49, wherein the sinus treatment current has
a zero DC offset.
62. The method of claim 50, wherein the current spikes make up less
than 10% of a single cycle during the treatment mode.
63. The method of claim 62, wherein the current spikes make up less
than 5% of a single cycle during the treatment mode.
64. The method of claim 49, further comprising applying the sinus
treatment current by applying a treatment stimulation voltage
between the conductive tip and the return electrode.
65. The method of claim 64, further comprising: adjusting the
stimulation voltage as the impedance between the conductive tip and
the return electrode changes during the treatment mode; and
maintaining a substantially constant sinus treatment current during
the treatment mode by adjusting the stimulation voltage responsive
to changes in the impedance during the treatment mode.
66. (canceled)
67. A method, comprising: detecting, during a detection mode, an
impedance through a user's body between a conductive tip of a sinus
treatment device and a return electrode of the sinus treatment
device; initiating a treatment mode of the sinus treatment device
responsive to the impedance; passing, during the treatment mode, a
treatment current through the user's body between the conductive
tip and the return electrode, the treatment current including a
series of current spikes; and gradually increasing a magnitude of
the current spikes during the treatment mode until the magnitude
reaches a predetermined treatment level.
68. The method of claim 67, wherein the treatment current has a
magnitude less than 1000 .mu.A.
69. The method of claim 68, wherein the series of current spikes
has a magnitude less than 600 .mu.A.
70. The method of claim 69, wherein the series of current spikes
alternates between positive and negative current values.
71. The method of claim 69, wherein the treatment current has a
substantially zero DC offset between consecutive current
spikes.
72. The method of claim 69, further comprising providing haptic
feedback to the user's body during the treatment mode.
73. A microcurrent sinus treatment device, comprising; a circuit
configured to deliver a sequence of voltage pulses carrying a
therapeutic current; a therapeutic electrode operatively coupled to
the circuit, the therapeutic electrode being configured to apply
the sequence of voltage pulses to a user's skin surface adjacent to
one of a plurality of nerve nodes subjacent to the user's skin
surface, the therapeutic electrode being in electrical continuity
with a therapeutic current output node of the circuit; and a hand
holdable case configured to substantially contain portions of the
circuit, the hand holdable case including: a forward end
terminating in the therapeutic electrode; a return electrode
comprising a portion of or disposed on a surface of the hand
holdable case, the return electrode being in electrical continuity
with a current return node of the circuit; a dielectric spacer
disposed between the therapeutic electrode and the return
electrode; and a rearward portion of the hand holdable case
terminating at an end distal to the therapeutic electrode tip;
wherein the dielectric spacer and the return electrode form a
tapered surface narrowing toward the therapeutic electrode from a
point of maximum girth disposed between the forward end and the
rearward portion of the hand holdable case.
74. The microcurrent sinus treatment device of claim 73, wherein
the therapeutic electrode includes a securing feature configured to
secure the return electrode against the rearward portion of the
hand holdable case to hold the dielectric spacer and the return
electrode together with the rearward portion of the hand holdable
case.
75. The microcurrent sinus treatment device of claim 74, wherein
the securing features of the therapeutic electrode includes a
threaded portion configured to screw into a hole formed inside the
rearward portion of the hand holdable case.
76. The microcurrent sinus treatment device of claim 73, wherein
relative placements of the therapeutic electrode, the dielectric
spacer, and the return electrode are configured to cause the user's
body to complete a circuit between the therapeutic electrode and
the return electrode.
77. (canceled)
78. The microcurrent sinus treatment device of claim 73, wherein
the hand holdable case forms a surface having an indentation larger
than an average user's thumb on a back side of the hand holdable
case such that a front portion of the indentation extends toward
the therapeutic electrode and away from the point of maximum girth
of the hand holdable case.
79. (canceled)
80. The microcurrent sinus treatment device of claim 73, wherein
the dielectric spacer defines a concave insulated surface near the
therapeutic electrode to make clearance for the user's cheek and/or
nose.
81. The microcurrent sinus treatment device of claim 73, wherein
the hand holdable case defines a tapered surface on a top, between
the point of maximum girth and the forward end, configured to
provide a finger hold.
82. The microcurrent sinus treatment device of claim 81, wherein
the tapered surface forms a facet relative to other portions of the
top.
83. The microcurrent sinus treatment device of claim 73, wherein
the hand holdable case defines a convex curved surface, on the top
between the point of maximum girth and the rearward portion,
configured to fit into a hollow of the user's palm.
84. (canceled)
85. The microcurrent sinus treatment device of claim 73, wherein
the hand holdable case further comprises a light pipe disposed
between the forward end and the return electrode, the light pipe
being configured to output an illumination indicator from a light
emitting diode (LED) disposed on the circuit to indicate an
operating condition to the user.
86. The microcurrent sinus treatment device of claim 73, further
comprising a button configured to cause the circuit to enter a low
current, nerve node finding mode, the circuit being further
configured to enter a high current therapeutic voltage pulse mode
when a nerve node is found and to automatically shut off when a
dose of therapeutic voltage pulses have been delivered.
87. The microcurrent sinus treatment device of claim 73, wherein an
exposed portion of the therapeutic electrode has a round
cross-section having a radius of curvature of greater than or equal
to 0.031 inch and less than or equal to 0.25 inch.
88.-89. (canceled)
90. The microcurrent sinus treatment device of claim 73, wherein
the exposed portion of the therapeutic electrode is formed from
stainless steel.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a Continuation-in-Part
Application which claims priority benefit under 35 U.S.C. .sctn.
120 (pre-AIA) of co-pending International Patent Application No.
PCT/US2018/029030, entitled "SINUS TREATMENT DEVICE WITH ENHANCED
TIP," filed Apr. 24, 2018 (docket number 3048-004-04).
International Patent Application No. PCT/US2018/029030 claims
priority benefit from U.S. Provisional Patent Application No.
62/491,793, entitled "SINUS DEVICE WITH ADAPTIVE CIRCUIT," filed
Apr. 28, 2017 (docket number 3048-001-02), now expired.
International Patent Application No. PCT/US2018/029030 also claims
priority benefit from U.S. Provisional Patent Application No.
62/559,792, entitled "TREATMENT DEVICE INCLUDING WIRELESS INTERFACE
AND USER APPLICATION," filed Sep. 18, 2017 (docket number
3048-007-02), now expired. International Patent Application No.
PCT/US2018/029030 also claims priority benefit from U.S.
Provisional Patent Application No. 62/560,120, entitled "ADAPTIVE
TRIGGER FOR A MICROCURRENT STIMULATION DEVICE," filed Sep. 18, 2017
(docket number 3048-031-02), now expired. Each of the foregoing
applications, to the extent not inconsistent with the disclosure
herein, is incorporated by reference.
BACKGROUND
[0002] Every year, millions of people suffer from sinus pain,
stuffiness, and drainage associated with colds, viruses,
rhinosinusitis, allergies, flus, inflammation, and infection. Sinus
pain can cause symptoms consistent with headaches as nasal cavities
become infected, swollen, and/or inflamed. Many sinus pain patients
resort to medications that can be taken orally but which also have
significant side effects including drowsiness, dry mouth, nausea,
and difficulty sleeping.
[0003] What is needed is an approach that can alleviate sinus
symptoms without the negative effects of conventional sinus
medications.
SUMMARY
[0004] According to an embodiment, a sinus treatment device
includes a housing configured to be held in a hand, a return
electrode operatively coupled to the housing, and a conductive tip.
The sinus treatment device includes sinus treatment circuitry
positioned within the housing and configured to detect sinus
treatment locations on a face of a user based on an impedance
between the conductive tip and the return electrode and to pass a
treatment current between the conductive tip and the return
electrode via the treatment location on the face of the user. The
sinus treatment device includes a resilient member coupled to the
conductive tip and configured to enable the conductive tip to
resiliently depress toward the housing.
[0005] According to an embodiment, a sinus treatment device
includes a housing configured to be held in a hand of a user, a
conductive tip coupled to the housing and having a distal surface
distal to the housing and a dielectric covering positioned on the
distal surface and defining a covered portion of the distal surface
and an exposed portion of the distal surface. The sinus treatment
device includes a return electrode operatively coupled to the
housing and sinus treatment circuitry positioned within the
housing. The sinus treatment circuitry is configured to detect
sinus treatment locations on a face of the user based on an
impedance between the conductive tip and the return electrode and
to pass a treatment current between the exposed portion of the
distal surface of the conductive tip and the return electrode via
the treatment location on the face of the user.
[0006] According to an embodiment, a method includes detecting an
impedance between a conductive tip of a sinus treatment device and
a return electrode of the sinus treatment device, initiating a
treatment mode of the sinus treatment device when the impedance
drops below a threshold by passing a sinus treatment current
between the conductive tip and the return electrode, and gradually
increasing a magnitude of the sinus treatment current during the
treatment mode.
[0007] According to an embodiment, a method includes detecting,
during a detection mode of a sinus treatment device, an impedance
between a conductive tip of the sinus treatment device and a return
electrode of the sinus treatment device, initiating a treatment
mode of the sinus treatment device responsive to the impedance, and
passing, during the treatment mode, a treatment current including a
series of current spikes. The method includes gradually increasing
a magnitude of the current spikes during the treatment mode until
the magnitude reaches a full treatment level.
[0008] According to an embodiment, a microcurrent sinus treatment
device includes a circuit configured to deliver a sequence of
voltage pulses carrying a therapeutic current, and a therapeutic
electrode operatively coupled to the circuit. The therapeutic
electrode may be configured to apply the sequence of voltage pulses
to a user's skin surface adjacent to one of a plurality of nerve
nodes subjacent to the user's skin surface. The therapeutic
electrode may be in electrical continuity with a therapeutic
current output node of the circuit. The microcurrent sinus
treatment device includes a hand holdable case configured to
substantially contain active portions of the circuit. The hand
holdable case includes a forward end terminating in the therapeutic
electrode, and a return electrode comprising a portion of or
disposed on a surface of the hand holdable case. The return
electrode may be in electrical continuity with a current return
node of the circuit. The hand holdable case also includes a
dielectric spacer disposed between the therapeutic electrode and
the return electrode, and a rearward portion of the hand holdable
case terminating at an end a distance less than about four inches
from the therapeutic electrode tip. The dielectric spacer and the
return electrode may form a tapered surface narrowing toward the
therapeutic electrode from a point of maximum girth disposed
between the forward end and the rearward end of the hand holdable
case.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1A is a perspective view of a handheld sinus treatment
device, according to an embodiment of the disclosure.
[0010] FIG. 1B is a top view of the handheld sinus treatment device
of FIG. 1A, according to an embodiment of the disclosure.
[0011] FIG. 1C is a bottom view of the handheld sinus treatment
device of FIG. 1A, according to an embodiment of the
disclosure.
[0012] FIG. 2 is an illustration of a handheld sinus treatment
device providing sinus relief treatment to highlighted treatment
areas adjacent to the sinuses of a user, according to an embodiment
of the disclosure.
[0013] FIGS. 3A and 3B illustrate nasal pathways and associated
nerves that a sinus treatment device may be applied to, according
to an embodiment of the disclosure.
[0014] FIG. 4 is a block diagram of a sinus treatment device,
according to an embodiment of the disclosure.
[0015] FIG. 5 illustrates an example adaptive output circuit for
use with a sinus treatment device, according to an embodiment of
the disclosure.
[0016] FIG. 6 is a graph of a treatment current vs time, according
to an embodiment of the disclosure.
[0017] FIG. 7 is a graph of a treatment current vs time including a
gradually increasing treatment current, according to an embodiment
of the disclosure.
[0018] FIG. 8 is an enlarged view of a portion of a sinus treatment
device, according to an embodiment of the disclosure.
[0019] FIG. 9A is an enlarged view of a portion of a sinus
treatment device including a resilient member, according to an
embodiment of the disclosure.
[0020] FIGS. 9B and 9C are enlarged views of a portion of a sinus
treatment device including a spring, according to an embodiment of
the disclosure.
[0021] FIGS. 9D and 9E are enlarged views of a portion of a sinus
treatment device including a flexible membrane, according to an
embodiment of the disclosure.
[0022] FIG. 10 is a flow chart of a process for operating a sinus
treatment device, according to an embodiment of the disclosure.
[0023] FIG. 11 is a flow chart of a process for operating a sinus
treatment device, according to an embodiment of the disclosure.
[0024] FIG. 12 shows several views of a microcurrent sinus
treatment device, according to an embodiment.
DETAILED DESCRIPTION
[0025] In the following detailed description, reference is made to
the accompanying drawings, which form a part hereof. In the
drawings, similar symbols typically identify similar components,
unless context dictates otherwise. Other embodiments may be used
and/or other changes may be made without departing from the spirit
or scope of the disclosure.
[0026] FIG. 1A is a perspective view of a handheld sinus treatment
device 102, according to an embodiment. The handheld sinus
treatment device 102 includes a body 106, a conductive tip 108, a
return electrode 110, and a charging port 112, according to an
embodiment.
[0027] According to an embodiment, the handheld sinus treatment
device 102 is configured to provide sinus treatment to a user. The
user holds the sinus treatment device 102 in one hand, with the
hand contacting the return electrode 110, places the conductive tip
108 against the skin in the sinus region (see FIGS. 3A-3B) and
glides the conductive tip 108 across the skin until the handheld
sinus treatment device 102 detects a treatment location. When the
handheld sinus treatment device 102 detects a treatment location,
the handheld sinus treatment device 102 directs the user to hold
the handheld sinus treatment device 102 still, and passes a
treatment current between the conductive tip 108 and the return
electrode 110. The treatment current passes through a nerve at the
treatment location, thereby providing sinus relief to the user.
[0028] According to an embodiment, the body 106 is a rigid casing
or housing. The body 106 has a shape that enables the user of the
handheld sinus treatment device 102 to securely grip and
comfortably hold the handheld sinus treatment device 102 during
operation of the handheld sinus treatment device 102.
[0029] In one embodiment, the body 106 can be made from a material
that is not electrically conductive. Alternatively, the body 106
can be made from a material that is electrically conductive, or can
include portions that are electrically conducive, according to an
embodiment. The body 106 can be made from a material that has low
thermal conductivity. The body 106 is configured to protect
sensitive electronic circuitry positioned within the body 106, as
is described in more detail with relation to FIGS. 4-5.
[0030] According to an embodiment, the conductive tip 108 is an
electrical conductor placed at a tip of the body 106. The
conductive tip 108 can include a rounded shape at a point of
contact with the skin of the user such that the conductive tip 108
can be placed against the skin of the user comfortably without
piercing or scratching the skin. Furthermore, the shape and
material of the conductive tip 108 can be selected to enable the
user to comfortably glide the conductive tip 108 along the skin of
the user's face adjacent to sinuses of the user. The conductive tip
108 is a treatment electrode, according to an embodiment.
[0031] According to an embodiment, the return electrode 110
includes an electrically conductive material positioned at various
locations on or in the body 106. The return electrode 110 can be
positioned in the body 106 at positions selected so that when the
user holds the handheld sinus treatment device 102 in the user's
hand, the user's hand is in contact with the return electrode 110
on one or more locations on the body 106. According to an
embodiment, the return electrode 110 can include a conductive
polycarbonate.
[0032] According to an embodiment, the charging port 112 is
positioned at the rear of the body 106 of the handheld sinus
treatment device 102. The charging port 112 is configured to
receive a charging cable. When the charging cable is connected to
the charging port 112, the internal battery of the handheld sinus
treatment device 102 is recharged. Additionally, or alternatively,
the charging port 112 can be a power supply port configured to
connect to a power cable that provides power to the handheld sinus
treatment device 102 while the user is using the handheld sinus
treatment device 102. The charging port 112 can be a micro USB
port, a USB 2.0 port, a USB 3.0 port, a USB C port, or any other
kind of port that can be utilized to charge the battery of the
handheld sinus treatment device 102, or to otherwise provide power
to the handheld sinus treatment device 102. Additionally, or
alternatively, the handheld sinus treatment device 102 can include
wireless charging capability. For example, the handheld sinus
treatment device 102 can include circuitry that enables inductive
charging of the battery of the handheld sinus treatment device 102
such that when the handheld sinus treatment device 102 is
positioned on a charging dock, the battery is recharged by
inductive charging.
[0033] FIG. 1B is a top view of a handheld sinus treatment device
102, according to an embodiment. The top view of the handheld sinus
treatment device 102 illustrates the body 106, the conductive tip
108, the return electrode 110, the charging port 112, indicators
114, a sensitivity setting button 116, a power button 118, and a
low battery indicator 120.
[0034] According to an embodiment, the indicators 114 can provide
an indication of the sensitivity level of the handheld sinus
treatment device 102. The sensitivity level corresponds to a
sensitivity setting for detecting treatment areas adjacent to the
sinuses of the user. The indicators 114 can include multiple LED
indicators. The handheld sinus treatment device 102 can illuminate
a number of the sensitivity level indicator LEDs 114 to indicate a
sensitivity level of the handheld sinus treatment device 102 during
a detection mode. A greater number of illuminated indicator LEDs
114 can correspond to a higher sensitivity level. A lesser number
of illuminated indicator LEDs 114 can correspond to a lower
sensitivity level. Alternatively, other schemes for illuminating
LEDs to indicate a sensitivity level of the detection mode of the
handheld sinus treatment device 102 can be utilized. Additionally,
the indicators 114 can include indicators other than LEDs. For
example, the indicators 114 can include various types of lights, a
display panel, or other types of indicators capable of providing an
indication of the sensitivity level of the handheld sinus treatment
device 102 during a detection mode of the handheld sinus treatment
device 102. According to an embodiment, the indicators 114 can also
signal that a treatment location has been identified, that
treatment stimulation is currently being provided, that another
treatment location should be identified, or other parameters of
operation of the handheld sinus treatment device 102.
[0035] According to an embodiment, the sensitivity setting button
116 is configured to enable the user to adjust the sensitivity of
the handheld sinus treatment device 102 during a detection mode.
The user can manipulate the sensitivity setting button 116 in order
to increase or decrease the sensitivity of the handheld sinus
treatment device 102. For example, the user can press the
sensitivity setting button 116 to adjust the sensitivity of the
handheld sinus treatment device 102. Additionally, or
alternatively, the user can toggle or slide the sensitivity setting
button 116 in order to adjust the sensitivity of the handheld sinus
treatment device 102. Additionally, or alternatively, the
sensitivity setting button 116 can include multiple buttons for
adjusting the sensitivity of the handheld sinus treatment device
102. A first button can be used to decrease the sensitivity. A
second button can be used to increase the sensitivity.
Additionally, or alternatively, the handheld sinus treatment device
102 can include a touchscreen that enables the user to adjust the
sensitivity of the handheld sinus treatment device 102.
[0036] According to an embodiment, the power button 118 is
configured to enable the user to turn the handheld sinus treatment
device 102 on or off. For example, if the handheld sinus treatment
device 102 is currently off, then the user can turn the handheld
sinus treatment device 102 on by pressing, toggling, sliding, or
otherwise manipulating, the power button 118. If the handheld sinus
treatment device 102 is currently on, then the user can turn the
handheld sinus treatment device 102 off by pressing, toggling,
sliding, or otherwise manipulating the power button 118.
Alternatively, the sensitivity setting button 116 and the power
button 118 can be implemented in a single button or switch that can
adjust the sensitivity or turn the handheld sinus treatment device
102 on or off based on a length of a button press, a number of
button presses, or other types of manipulations of the single
button.
[0037] According to an embodiment, the low battery indicator 120
can provide an indication of a state of charge of the battery of
the handheld sinus treatment device 102. The low battery indicator
120 can include one or more LEDs. When the battery of the handheld
sinus treatment device 102 is low, one or more LEDs of the low
battery indicator 120 can become illuminated. If the low battery
indicator 120 includes a single LED, then the single LED can become
illuminated when the battery is nearing depletion. Conversely, the
single LED may not be illuminated when the battery is not nearing
depletion. Alternatively, when the battery is nearing depletion, a
first LED of a first color can be illuminated to indicate that the
battery is nearing depletion. If the battery is not nearing
depletion, then a second LED of a second color can be illuminated
indicating that the battery is not nearing depletion.
[0038] According to an embodiment, portions of the return electrode
110 are positioned on the sides of the body 106 of the handheld
sinus treatment device 102. When the user grips the handheld sinus
treatment device 102 such that a thumb of the user is in a position
to manipulate the sensitivity setting button 116 and the power
button 118, the palm and/or fingers of the hand of the user will be
in contact with the portion of the return electrode 110 positioned
on the sides of the body 106 of the handheld sinus treatment device
102.
[0039] FIG. 1C is a bottom view of the handheld sinus treatment
device 102 of FIG. 1B, according to an embodiment. The bottom view
of the handheld sinus treatment device 102 illustrates a portion of
the return electrode 110 positioned on the bottom portion of the
body 106 of the handheld sinus treatment device 102. The
positioning of a portion of the return electrode 110 on the bottom
of the body 106 of the handheld sinus treatment device 102 further
ensures that when the user holds the handheld sinus treatment
device 102 in the user's hand, the user's hand will be in contact
with the return electrode 110.
[0040] FIG. 2 is an illustration of a face 226 of a user of the
handheld sinus treatment device 102 highlighting treatment areas
228. According to an embodiment, the treatment areas 228 correspond
to nerve nodes. The nerve nodes are treatment locations 228 at
which sinus nerves pass through the skull.
[0041] According to an embodiment, the user uses the handheld sinus
treatment device 102 by holding the body 106 in one hand such that
the user's hand is in contact with portions of the return electrode
110. The user then places the conductive tip 108 on the skin
adjacent to the sinuses and glides the conductive tip 108 over the
skin during a detection mode of the handheld sinus treatment device
102. In the detection mode, the handheld sinus treatment device 102
detects the treatment location 228, corresponding to the location
of a nerve node beneath the skin. When the handheld sinus treatment
device 102 detects the treatment location 228 of a nerve node
beneath the skin, the handheld sinus treatment device 102 can enter
a treatment mode.
[0042] In one embodiment, the handheld sinus treatment device 102
detects treatment locations 228 by detecting an impedance between
the conductive tip 108 and the return electrode 110. Treatment
locations 228 are characterized by a lower impedance than
surrounding areas due to enhanced conductivity of nerves.
[0043] According to an embodiment, in the treatment mode, the
handheld sinus treatment device 102 provides treatment stimulation
to the treatment location 228, corresponding to the nerve that is
located during the detection mode. The handheld sinus treatment
device 102 can provide treatment stimulation to the treatment
location 228 by providing electrical stimulation to the treatment
location 228. The electrical stimulation can affect the nerve node
in such a way that the user experiences relief from troubling sinus
symptoms such as pain, congestion, inflammation, or other
unpleasant symptoms.
[0044] According to an embodiment, the handheld sinus treatment
device 102 is a transcutaneous electrical nerve stimulation (TENS)
device. The handheld sinus treatment device 102 applies electrical
treatment stimulation in the form of a treatment current having
selected characteristics. The treatment current can have an average
magnitude that is multiple orders of magnitude lower than common
TENS devices. According to an embodiment, the treatment current
does not have a DC component, but is characterized by current
spikes of alternating polarity. According to an embodiment, the
treatment stimulation is provided at each treatment location 228
for a period of time between 2-10 seconds.
[0045] According to an embodiment, the handheld sinus treatment
device 102 applies the treatment current by applying a stimulation
voltage between the conductive tip 108 and the return electrode
110.
[0046] According to an embodiment, the conductive tip 108 is the
active electrode of a monopolar design. The housing/body 106 of the
handheld sinus treatment device 102 may serve as the return
electrode 110 when return electrodes 110 are integrated into the
body 106. A user's hand holding the handheld sinus treatment device
102 completes the electrical path from the conductive tip 108 to
the return electrode(s) 110 in that currents may travel from the
conductive tip 108, through the nasal area of the user and down to
the hand of the user that is contacting the return electrode(s)
110, in an embodiment. These currents may be referred to as
"treatment currents" in this disclosure.
[0047] According to an embodiment, in the detection mode, the user
presses the conductive tip 108 to the skin and the handheld sinus
treatment device 102 initiates a low-frequency circuit that is
maintained at a constant current. The handheld sinus treatment
device 102 may use the current to calculate the impedance in the
path between the tissue at the conductive tip 108 and the hand in
contact with the handheld sinus treatment device 102. The handheld
sinus treatment device 102 remains in the detection mode until the
detection current indicates that the impedance is below a threshold
impedance. The position of the conductive tip 108 when the
impedance is below the threshold impedance corresponds to a
treatment area 228. The treatment area 228 corresponds to a nerve
node area. When the handheld sinus treatment device 102 identifies
a treatment area 228 based on the calculated impedance, the
handheld sinus treatment device 102 can enter the treatment mode
and can deliver treatment stimulation to the identified treatment
area 228.
[0048] According to an embodiment, the handheld sinus treatment
device 102 can indicate to the user that the handheld sinus
treatment device 102 is in the treatment mode and that the user
should hold the conductive tip 108 at the treatment location 228
for a selected period of time. According to an embodiment, the
handheld sinus treatment device 102 can indicate the transition
between the detection mode and the treatment mode by the indicators
114. The indicators 114 can include one or more LEDs that can
provide an illumination scheme that indicates whether the handheld
sinus treatment device 102 is in the detection mode or the
treatment mode. According to an embodiment, the handheld sinus
treatment device 102 can indicate that the handheld sinus treatment
device 102 is in the treatment mode via haptic feedback
(vibration). According to an embodiment, the handheld sinus
treatment device 102 can indicate whether the handheld sinus
treatment device 102 is in the detection mode, the treatment mode,
or transitioning between the detection and the treatment modes by a
combination of haptic feedback and the LED indicators 114.
According to an embodiment, when the handheld sinus treatment
device 102 enters the treatment mode as indicated by one or more of
the LED indicators 114 and haptic feedback, the user holds the
handheld sinus treatment device 102 in place until the treatment
period has passed as indicated by cessation of haptic feedback and
the LED indicators 114 (approximately 8 seconds in one
example).
[0049] According to an embodiment, once the treatment period ends,
the handheld sinus treatment device 102 resets to detection mode.
The user then may continue to glide the handheld sinus treatment
device 102 along the indicated path until reaching the next
treatment area 228 as identified based on impedance calculations.
The user may adjust the impedance sensitivity of the handheld sinus
treatment device 102, in one embodiment. Changes in sensitivity
adjust the impedance threshold at which the handheld sinus
treatment device 102 will enter treatment mode. Changes in
sensitivity do not change the output current, in one
embodiment.
[0050] In one embodiment of a treatment circuit of the disclosed
handheld sinus treatment device 102, the constant current
stimulation output is approximately 1 Hz-1000 Hz, bi-phasic, no DC
component signal with an average current less than 1000 .mu.A over
a resistive load of 10K-100K.OMEGA.. The signal is presented to the
user by means of the conductive tip 108, in one embodiment.
According to an embodiment, the spring-loaded conductive tip 108
activates the circuit and gently ramps the current to provide
maximal comfort to the user.
[0051] According to an embodiment, constant current stimulation
circuit output is directed to the conductive tip 108 and returned
to the circuit by way of the return electrode 110 (metallized
portions of the enclosure). When the circuit is completed by the
user pressing the device conductive tip 108 to the face 226, a
microcontroller monitors the resulting treatment current and
controls the stimulation voltage (across the conductive tip 108 and
the return electrode 110) to maintain the desired current, in one
embodiment. The impedance of the circuit is then calculated and
monitored by the microcontroller. In the event that the impedance
falls below a specified threshold, which is indicative of a
treatment location 228, the microcontroller presents a treatment
prompt through a user interface (UI), in one embodiment. According
to an embodiment, the user is instructed to maintain the conductive
tip 108 location until the treatment prompt has timed out. After
treatment time out, the user is instructed to slowly move the
conductive tip 108 to the next detected treatment location 228, in
one embodiment.
[0052] According to an embodiment, the sensitivity level setting
determines the impedance threshold at which the handheld sinus
treatment device 102 will signal the user to detection of a
treatment location 228. The treatment sensitivity threshold may be
increased to compensate for higher impedance associated with dry
skin or the presence of makeup, in one embodiment. Upon detection
of a treatment location 228, the haptic motor starts to vibrate and
the sensitivity level indicator LEDs 114 flash for a pre-programmed
period of time, in one embodiment. If the calculated impedance
increases above the threshold (conductive tip 108 removed from the
face 226 or moved to a higher impedance location on the face 226),
the treatment session may be terminated.
[0053] In one embodiment, the handheld sinus treatment device 102
is used as a handheld microcurrent TENS device used for the
temporary relief of sinus pain. The handheld sinus treatment device
102 uses an average treatment current that is several orders of
magnitude smaller than that of previously cleared TENS devices, in
one embodiment. In one embodiment, the handheld sinus treatment
device 102 is a sinus treatment device designed to provide
transcutaneous nerve stimulation to the regional areas associated
with the sinuses, and current levels are attuned to those
appropriate for facial treatments, as seen in predicate facial
toners.
[0054] The sinus treatment device 102 is held in the hand, with the
conductive tip 108 of the handheld sinus treatment device 102
applied to the skin on the outside of the sinus passages. In one
embodiment, the conductive tip 108 is the active electrode of a
monopolar design. The housing/body 106 of the handheld sinus
treatment device 102 may serve as the return electrode 110 when
return electrodes 110 are integrated into the body 106. A user's
hand holding the sinus treatment device 102 completes the
electrical path from the conductive tip 108 to the return
electrode(s) 110 in that treatment currents may travel between the
conductive tip 108 and the return electrode 110 through the nasal
area. The treatment current can be passed in either direction
between the conductive tip 108 and the return electrode 110 through
the body of the user, according to an embodiment. The treatment
current can alternate directions during the treatment mode,
according to an embodiment.
[0055] In one embodiment, when the user turns the handheld sinus
treatment device 102 "ON" and presses the conductive tip 108 to the
skin, the handheld sinus treatment device 102 initiates a
low-frequency circuit that is maintained at a constant detection
current. The handheld sinus treatment device 102 may use the
detection current to calculate the impedance in the path between
the tissue at the conductive tip 108 and the hand in contact with
the handheld sinus treatment device 102. In one embodiment, if the
calculated impedance is above an impedance threshold, the handheld
sinus treatment device 102 is in "detection" mode. Conversely, in
one embodiment, when the impedance falls below the impedance
threshold, the handheld sinus treatment device 102 enters a
"treatment" mode. In one embodiment, in the treatment mode the
treatment current is has a greater magnitude than the current used
in the detection mode.
[0056] In one embodiment, the user is instructed to glide the
conductive tip 108 of the handheld sinus treatment device 102 along
the skin, in accordance with an embodiment of the disclosure. The
switch (transition) from detection mode to the treatment mode is
signaled to the user via haptic (vibration) feedback and blinking
of the indicator LEDs 114, in one embodiment. The user then holds
the handheld sinus treatment device 102 in place until the
treatment period has passed as indicated by cessation of haptic and
LED indicators 114 (approximately 8 seconds in one example), in one
embodiment.
[0057] In one embodiment, once the treatment period ends, the
handheld sinus treatment device 102 resets to detection mode. The
user then may continue to glide the handheld sinus treatment device
102 along the indicated path until reaching the next low-impedance
area. The user may adjust the impedance sensitivity of the handheld
sinus treatment device 102, in one embodiment. Changes in
sensitivity adjust the impedance threshold at which the handheld
sinus treatment device 102 will enter treatment mode. Changes in
sensitivity do not change the treatment current, in one
embodiment.
[0058] In one embodiment, the sensitivity setting button 116 may
allow a user to toggle through different sensitivity levels that
may be indicated by the example illustrated three indicator LEDs
114, in FIGS. 1A-1C. In one embodiment, an overcoat/insulator may
cover the body 106 of the handheld sinus treatment device 102
except for where the return electrode 110 provides an electrical
path.
[0059] In one embodiment, the conductive tip 108 includes an
elastomeric material intended to minimize point pressure against
the face 226 of the user. Various elastomers including silicone,
fluorine-substituted silicones, natural rubber, vulcanized rubber,
latex, latex derivatives, etc. may be used alone or in combination
to form a support structure of the conductive tip 108. In another
embodiment, a non-elastomeric dielectric material such as a
polymer, polymer combination, or glass may be used alone or in
combination to form the support structure of the active electrode.
The support structure may be formed to have a relatively low
thermal conductivity and/or may have a smooth radius to reduce
point pressure against the skin of the user. Various conductive
fibers or particles such as gold, silver, stainless steel, carbon
fiber, carbon nanotubes, and/or alternating bond length
(electron-conjugated) polymers are contemplated as current carriers
supported by a dielectric support structure.
[0060] In one embodiment, the handheld sinus treatment device 102
includes a spring-loaded conductive tip 108 and the conductive tip
108 is a small surface area metalized feature (tip) of the
enclosure that is applied to the treatment regions of the face 226.
In one embodiment, a microswitch initiates the therapy circuit when
the conductive tip 108 is depressed. The handheld sinus treatment
device 102 may include a microprocessor, microcontroller, a
battery, and a transformer/voltage step-up circuit. In one
embodiment, the return electrode 110 is a large surface area
metalized region of the enclosure that is in contact with the
user's hand.
[0061] In one embodiment, the user interface of the handheld sinus
treatment device 102 includes an LED treatment indicator 114 (e.g.,
LEDs 114), a sensitivity level adjustment button 116, and a haptic
feedback circuit. The LED sensitivity level indicates selected
sensitivity levels in addition to low battery and charge status, an
on/off button with integrated LED(s) 118 to indicate "on" or "off"
state, and a haptic feedback circuit.
[0062] In one embodiment, the handheld sinus treatment device 102
includes an overcoat that is electrically insulated. The overcoat
may cover a portion of the metalized return electrode 110 so long
as a portion (e.g., 10%) of the return electrode 110 is exposed. In
one embodiment, the handheld sinus treatment device 102 includes a
battery charging port 112 and circuit to charge an internal
battery.
[0063] As described above, the handheld sinus treatment device 102
may be used as a TENS device that applies microamp electrical
stimulation to facial nerves around the sinuses which are the
regions around the nose and the supraorbital region of the eye. The
locations of the low impedance points in the facial skin correlate
strongly with various foramina (holes) through which major nerve
fibers pass from the sinus passages, through the skull, to areas
near the skin.
[0064] FIGS. 3A and 3B illustrate nasal pathways and associated
nerves that the handheld sinus treatment device 102 may be applied
to by a user to facilitate treatment/therapy.
[0065] In one embodiment of a treatment circuit of the disclosed
handheld sinus treatment device 102, the constant current
stimulation output is approximately 1 Hz-1000 Hz, bi-phasic, no DC
component signal with an average current -less than 1000 .mu.A over
a resistive load of 10K-100K.OMEGA.. The signal is presented to the
user by means of the monopolar electrode, in one embodiment. In one
embodiment, the spring-loaded conductive tip 108 activates the
circuit and gently ramps the current to provide maximal comfort to
the user.
[0066] In one embodiment, constant current stimulation circuit
output is directed to the conductive tip 108 (the device tip 108)
and returned to the circuit by way of the return electrode 110
(metallized portions of the enclosure). When the circuit is
completed by the user pressing the device conductive tip 108 to the
face 226, a microcontroller monitors the resulting treatment
current and controls the stimulation voltage (across the conductive
tip 108 and return electrode 110) to maintain the desired current,
in one embodiment. The impedance of the circuit is then calculated
and monitored by the microcontroller. In the event that the
impedance falls below a specified threshold, which is indicative of
a treatment location 228, the microcontroller presents a treatment
prompt through the user interface (UI), in one embodiment. In one
embodiment, the user is instructed to maintain the conductive tip
108 location until the treatment prompt has timed out. After
treatment time out, the user is instructed to slowly move the
conductive tip 108 to the next detected treatment location 228, in
one embodiment.
[0067] In one embodiment, the sensitivity level setting determines
the impedance threshold at which the handheld sinus treatment
device 102 will signal the user to detection of a treatment
location 228. The treatment sensitivity threshold may be increased
to compensate for higher impedance associated with dry skin or the
presence of makeup, in one embodiment. Upon detection of a
treatment location 228, the haptic motor starts to vibrate and the
sensitivity level indicator LEDs 116 flash for a pre-programmed
period of time, in one embodiment. If the calculated impedance
increases above the threshold (conductive tip 108 removed from the
face 226 or moved to a higher impedance location on the face 226),
the treatment session may be terminated.
[0068] FIG. 4 is a block diagram of the handheld sinus treatment
device 102, according to an embodiment. The handheld sinus
treatment device 102 includes a sinus treatment circuitry (or
current output circuit) 429, the charging port 112, the indicators
114, a user interface 430, a memory 432, a microcontroller 434, a
motor 437, and a battery 438. The current output circuit 429
includes the conductive tip 108 and the return electrode 110. The
handheld sinus treatment device 102 utilizes these components to
provide effective sinus relief treatments to the user.
[0069] According to an embodiment, the conductive tip 108 and the
return electrode 110 cooperate together to provide both detection
currents and treatment stimulation. Detection and treatment
currents are passed between the conductive tip 108 and the return
electrode 110 through the body of the user. In particular, the
conductive tip 108 is positioned in contact with the user's skin to
the sinus areas of the user. The return electrode 110 is in contact
with the user's hand as the user holds the handheld sinus treatment
device 102. The detection and treatment currents pass between the
conductive tip 108 and the return electrode 110 via the hand, body,
and facial skin of the user.
[0070] According to an embodiment, the indicators 114 provide
indications to the user as to the current mode of operation of the
handheld sinus treatment device 102. The indicators 114 can include
one or more LEDs that can be illuminated in selected ways to
indicate whether the handheld sinus treatment device 102 is powered
on, whether the handheld sinus treatment device 102 is in a
treatment mode, whether the handheld sinus treatment device 102 is
in a detection mode, whether the handheld sinus treatment device
102 awaits user input, or indications of other types of
functionality of the handheld sinus treatment device 102. According
to an embodiment, the indicators 114 can include a display capable
of outputting text or images to indicate to the user the various
functions of the handheld sinus treatment device 102.
[0071] According to an embodiment, the user interface 430 includes
various components that enable the user to control functionality of
the handheld sinus treatment device 102. The user interface 430 can
include the power on-off button 118, the sensitivity setting button
116, or other kinds of buttons, switches, touchscreens, or input
controls that enable the user to control functionality of the
handheld sinus treatment device 102. The user can manipulate the
user interface 430 in order to control the functionality of the
handheld sinus treatment device 102.
[0072] According to an embodiment, the memory 432 stores data
related to the functionality of the handheld sinus treatment device
102. The memory 432 can include software instructions by which the
various functionalities of the handheld sinus treatment device 102
can be implemented. The memory 432 can include reference impedance
values and/or threshold impedance values. The reference and
threshold impedance values can be utilized in the detection mode of
the handheld sinus treatment device 102. The memory 432 can include
data indicating previously detected treatment locations 228. The
memory 432 can include other settings such as treatment lengths,
treatment stimulation strengths, frequencies of treatments, or
other settings including default settings and user selected
settings for operation of the handheld sinus treatment device 102.
The memory 432 can include one or more of EEPROMs, flash memory,
ROMs, SRAM, DRAM, or other kinds of computer readable media capable
of storing instructions that can be executed by the microcontroller
434.
[0073] According to an embodiment, the motor 437 enables the
handheld sinus treatment device 102 to provide haptic feedback to
the user. For example, during a treatment mode in which the
handheld sinus treatment device 102 provides stimulation treatment
to a treatment area 228, the motor 437 can cause the handheld sinus
treatment device 102 to vibrate mildly to indicate to the user that
the handheld sinus treatment device 102 is in the treatment mode.
The motor 437 can cease the vibration to indicate that the handheld
sinus treatment device 102 is no longer in the treatment mode. The
motor 437 can generate vibrations to provide a variety of types of
indications to the user of the handheld sinus treatment device
102.
[0074] According to an embodiment, the battery 438 provides power
to the handheld sinus treatment device 102. The battery 438 can
include a rechargeable battery 438 that enables the user to
recharge the battery 438 after the battery 438 has become depleted
through use. The battery 438 can be a lithium-ion battery, a NiCad
battery, a carbon zinc battery, an alkaline battery, a nickel metal
hydride battery, or other types of batteries.
[0075] According to an embodiment, the charging port 112 enables
the user to recharge the battery 438. For example, the charging
port 112 can be configured to receive a charging cable that
connects the charging port 112 to a power source. The charging port
112 can include a micro USB port, a USB 2.0 port, a USB 3.0 port, a
USB C port, or other types of charging ports. According to an
embodiment, the charging port 112 enables charging and data
transmission. When a charging cable is plugged into the charging
port 112, the battery 438 can be charged and data can be received
or transmitted over the charging cable via the charging port 112.
According to an embodiment, the handheld sinus treatment device 102
can operate while a charging cable is attached to the charging port
112. Thus, if the battery 438 is depleted, the user can attach a
charging cable to the charging port 112 and can operate the
handheld sinus treatment device 102 from power received via the
charging port 112.
[0076] According to an embodiment, the microcontroller 434 controls
the functionality of the other components of the handheld sinus
treatment device 102. The microcontroller 434 is communicatively
coupled to the conductive tip 108, the return electrode 110, the
indicators 114, the memory 432, the user interface 430, and the
charging port 112.
[0077] According to an embodiment, the microcontroller 434 executes
the software instructions stored in the memory 432 to implement the
various modes of functionalities of the handheld sinus treatment
device 102. The microcontroller 434 causes the conductive tip 108
and the return electrode 110 to pass the detection currents in the
detection mode, and to pass the treatment currents in the treatment
mode. The microcontroller 434 controls the indicators 114 to
indicate the various modes of functionalities of the handheld sinus
treatment device 102. The microcontroller 434 communicates with the
user interface 430 to enable the user to select various modes of
operation of the handheld sinus treatment device 102.
[0078] FIG. 5 illustrates an example sinus treatment circuitry 500
for use with the handheld sinus treatment device 102, according to
an embodiment of the disclosure. The sinus treatment circuitry 500
is positioned within the housing/body 106, according to one
embodiment. The sinus treatment circuitry 500 includes a
microcontroller 434 including a memory 432 and an analog-to-digital
converter (ADC) 593. In the illustrated embodiment of FIG. 5, the
sinus treatment circuitry 500 also includes a stimulation driver
stage and a peak detector.
[0079] In one embodiment, the stimulation driver stage is coupled
to apply a stimulation voltage between the conductive tip (active
electrode TP2) and the return electrode 110 (not illustrated in
FIG. 5). In the illustrated embodiment, the stimulation driver
stage includes a digital-to-analog converter (DAC), an amplifier, a
transformer, and a capacitor. In one embodiment, the DAC (U6) is
coupled to generate an analog voltage (pin 1 of U6, VOUT) in
response to a digital instruction from the microcontroller 434
received via the MOSI (Master Out Slave In) communication channel
of pin 4 of U6.
[0080] In the illustrated embodiment, the amplifier includes
transistors Q5 and Q6 and is coupled to generate an amplified
analog voltage (emitter node of Q5) in response to receiving the
analog voltage from the DAC (U6).
[0081] In the illustrated embodiment, the transformer T1 includes a
primary side (nodes 3 and 4) and a secondary side (nodes 1 and 2).
The conductive tip (active electrode TP2) is coupled to node 1 of
the secondary side of the transformer T1, in the illustrated
embodiment.
[0082] In the illustrated embodiment, capacitor C10 is coupled
between the amplifier and a primary side of the transformer T1 to
block the DC (direct current) portions of the amplified analog
signal.
[0083] In one embodiment, the peak detector includes a diode
element, a buffer circuit, and a sample and hold circuit. In the
illustrated embodiment, the diode element is D7. In one embodiment,
the buffer circuit is coupled to output a peak treatment current
signal. In one embodiment, the peak detector is coupled to generate
a peak treatment current signal on the node 1 output of op-amp U5
in response to receiving a stimulation signal from the conductive
tip TP2. In the illustrated embodiment, the stimulation signal may
travel from the conductive tip TP2 to node 2 of the transformer T1
via node 1 of the transformer T1.
[0084] In one embodiment, the sample and hold circuit is coupled
between the diode element (e.g., D7) and the buffer circuit and the
diode element is coupled between the secondary side of the
transformer and the sample and hold circuit. In the illustrated
embodiment, the sample and hold circuit includes resistors R26 and
capacitor C11.
[0085] In one embodiment, the microcontroller 434 is coupled to
receive the peak treatment current signal (SENSE) from the peak
detector and coupled to the stimulation driver stage for adjusting
the stimulation voltage in response to the peak treatment current
signal. In one embodiment, the microcontroller 434 dynamically
adjusts the stimulation voltage to keep the peak treatment current
signal at a constant value. In one embodiment, microcontroller 434
includes ADC 593 coupled to sample the peak treatment current
signal and drive the digital instruction to the DAC U6 (via MOSI
communication channel) to keep the peak treatment current signal at
the constant value.
[0086] The sinus treatment circuitry 500 of FIG. 5 provides a means
to maintain a nearly constant (and comfortable) treatment current
in response to varying resistance or impedance. Turning to a more
specific description of an embodiment of sinus treatment circuitry
500, a digital-to-analog converter (DAC) U6 receives commands from
the microcontroller 434 to generate a square wave with a variable
amplitude of 0 to +Vcc volts. The DAC U6 output is current limited
by R22 and is used to drive a push-pull output power stage
comprised of Q5 and Q6, in the illustrated embodiment. The output
of the push-pull stage is AC coupled by capacitor C10 and drives
the primary side of a step-up transformer T1. Capacitor C10 blocks
the DC component of the square wave and allows through only the
rising and falling edges of the square wave. The transformer T1
converts the high current, low voltage edge input to the high
voltage, low (microcurrent) treatment current output, in the
illustrated embodiment.
[0087] One end of the secondary side of the transformer is
connected to the conductive tip 108. The other end of the secondary
coil is connected to a dual diode array D7. The diode array acts as
the treatment current positive peak detector. Resistor R26 and
capacitor C11 provide a simple sample and hold function of the
detected peak. The peak detector output is buffered by op-amp U5.
The output of the op-amp U5 is then sampled by the ADC 593 of the
microcontroller 434.
[0088] During use, a control loop is formed by the DAC U6, peak
detector, and the microcontroller 434 ADC 593. The sensed positive
peaks of the treatment current are maintained at a constant level
by controlling the DAC U6 output. As the total resistance
decreases, the control loop reduces the DAC U6 output which reduces
the amplitude of the edges being input to the transformer T1. The
control loop effectively converts the voltage source output of the
transformer T1 to a constant current source, in the illustrated
embodiment. In this manner, any uncomfortable surges in current are
reduced during treatment.
[0089] FIG. 6 is a graph 600 of a treatment current (I) vs time
(t), according to an embodiment. The treatment current is applied
during a treatment mode of the handheld sinus treatment device 102
after the handheld sinus treatment device 102 has identified a
treatment location 228. The treatment current provides relief to
sinus discomfort and users.
[0090] According to an embodiment, the treatment current
corresponds to a series of sharp current spikes 650 or peaks.
According to an embodiment, successive current spikes 650 alternate
in direction such that every other current spike 650 flows in a
first direction, while intervening current spikes 650 flow in a
second, opposite, direction.
[0091] According to an embodiment, the current spikes 650
correspond to the rising and falling edges of a square wave voltage
signal. In one embodiment, the treatment current is generated by
feeding a square wave voltage signal to a transformer, such as the
transformer T1, via a capacitor, such as the capacitor C10. Those
of skill in the art will recognize, in light of the present
disclosure, that a treatment current in accordance with FIG. 6 can
be generated in various ways. All such other ways for generating
the treatment current fall within the scope of the present
disclosure.
[0092] In one embodiment, the treatment current has no DC offset.
The lack of a DC offset can enhance the therapeutic effect of the
treatment current. This is because, in one interpretation, the
rapid changes in current magnitude and direction promote
physiological effects that do not occur in the presence of a DC
current.
[0093] In one embodiment, the sinus treatment circuitry 429,
including the microcontroller 434 and the memory 432, adjust the
stimulation voltage between the conductive tip 108 and the return
electrode 110 to maintain a constant treatment current during the
treatment mode. In one embodiment, maintaining a constant treatment
current corresponds to causing the current spikes 650 or peaks of
the treatment current to have substantially the same magnitudes. In
one embodiment, maintaining a constant treatment current
corresponds to causing the current spikes 650 or peaks of the
treatment current to have substantially the same absolute values.
Thus, the positive current peaks 650 and the negative current peaks
650 have the same absolute value, in one embodiment. Alternatively,
maintaining a constant treatment current corresponds to causing the
positive current spikes 650 or peaks to have a same first
magnitude, and causing the negative current spikes 650 or peaks to
have a same second magnitude.
[0094] In one embodiment, the current spikes 650 or peaks of the
sinus treatment current have a magnitude less than or equal to 1000
.mu.A. In one embodiment, the current spikes 650 or peaks of the
sinus treatment current have a magnitude less than or equal to 600
.mu.A. In one embodiment, the peaks of the treatment current spikes
650 or peaks have a magnitude less than or equal to 600 .mu.A. In
one embodiment, the sinus treatment current spikes 650 have an
average current less than or equal to 1000 .mu.A. In one
embodiment, the sinus treatment current spikes 650 have an average
current less than or equal to 600 .mu.A.
[0095] In one embodiment, the frequency of the treatment current is
less than 1000 Hz. In one embodiment, the period of a single
treatment current cycle corresponds to the time between current
peaks 650 of the same direction. In one embodiment, the frequency
of the treatment current is between 1 Hz and 100 Hz. In one
embodiment, the spikes in the treatment current 650 make up less
than 10% of a single cycle. In one embodiment, the spikes in the
treatment current 650 make up less than 5% of a single cycle. In
one embodiment, the spikes in the treatment current 650 make up
about 3% of a single cycle.
[0096] In one embodiment, during the treatment mode, the handheld
sinus treatment device 102 measures the impedance by measuring the
current spikes 650 or peaks of the treatment current. In one
embodiment, the handheld sinus treatment device 102 adjusts a
stimulation voltage applied between the conductive tip 108 and the
return electrode 110 to bring the magnitude of the current spikes
650 or peaks of the treatment current back to a desired constant
value.
[0097] Those of skill in the art will recognize, in light of the
present disclosure, that in practice the treatment current may vary
from the graph 600. For example, the risetime and fall time of a
given current spike 650 may not be identical. The rise times and
fall times of separate current spikes 650 may not be identical to
each other. A given current spike 650 can include, at the tail end,
a brief portion that flows in the opposite direction to the primary
direction of the current spike 650. In a constant current
situation, the current spikes 650 may have slightly differing
magnitudes while remaining substantially the same. There may be
noise present among the current waveform. All such variations from
the graph 600 fall within the scope of the present disclosure.
[0098] In one embodiment, in the detection mode in which the
handheld sinus treatment device 102 identifies treatment locations
228, the handheld sinus treatment device 102 measures the impedance
by applying a detection current with a waveform similar or
identical to the treatment current waveform and measuring the
magnitude of the current peaks of the detection current in order to
determine the impedance. In one embodiment, the handheld sinus
treatment device 102 measures the impedance by passing a detection
current with a smaller magnitude than the treatment current. In one
embodiment, during the detection mode, the handheld sinus treatment
device 102 applies a detection voltage that is lower than the
stimulation voltage applied during the treatment mode. In one
embodiment, the handheld sinus treatment device 102 measures the
impedance by passing a detection current with a waveform entirely
different than the treatment current waveform.
[0099] FIG. 7 is a graph 700 of a treatment current (I) vs time
(t), according to an embodiment. Similar to the graph 600 of FIG.
6, the treatment current includes a series of current spikes 650.
The treatment current is passed between the conductive tip 108 and
the return electrode 110 through the body of the user during the
treatment mode of the handheld sinus treatment device 102.
[0100] In order to promote the further comfort of the user during
the treatment mode, the magnitude of the treatment current is
gradually increased during the treatment mode. In particular, at
the beginning of the treatment mode, successive current spikes 650
increase in magnitude until the treatment current has arrived at
the full treatment level. In this way, during the treatment mode,
the user does not immediately receive the full magnitude of the
current spikes 650, but rather the magnitude of the current spikes
650 gradually increased in a comfortable manner to a full treatment
level.
[0101] In one embodiment, a first current spike 650a has a
magnitude that is much smaller than a full treatment level. A
second current spike 650b has a magnitude or absolute value that is
greater than the magnitude of the first current spike 650a, though
in the opposite direction. A third current spike 650c has a
magnitude or absolute value that is greater than the second current
spike 650b. A fourth current spike 650d has a magnitude or absolute
value that is greater than the third current spike 650c. A fifth
current spike 650e has a magnitude or absolute value that is
greater than the fourth current spike 650d. A sixth current spike
650f has a magnitude or absolute value that is greater than the
fifth current spike 650e. A seventh current spike 650g has a
magnitude or absolute value that is greater than the sixth current
spike 650f. The magnitude of the seventh current spike 650g
corresponds to the full treatment level. In one embodiment, all of
the successive current spikes 650h-650i that follow the seventh
current spike 650g have a same magnitude or absolute value
corresponding to the full treatment level. The treatment mode for a
given treatment location 228 can include a much larger number of
current spikes 650 than are shown in the graph 700 depending on the
duration of the treatment mode and the frequency of the treatment
current.
[0102] In one embodiment, the current spikes 650 in a first
direction ramp up to a first direction full treatment level, while
the current spikes 650 in the second direction ramp up to a second
direction full treatment level different than the first direction
full treatment level.
[0103] In one embodiment, after the treatment current has been
applied to a treatment location 228 and identified during a
treatment mode, the user proceeds to locate the next treatment
location 228 during a subsequent detection mode. When the user has
located the next treatment location 228, the handheld sinus
treatment device 102 applies a treatment current that ramps up to a
full treatment level similar to the previous treatment mode.
[0104] FIG. 8 is an enlarged view of a portion of the handheld
sinus treatment device 102, according to one embodiment. The
conductive tip 108 extends from the housing 106. The conductive tip
108 includes a distal surface 856 distal from the housing 106. The
conductive tip 108 includes a columnar portion 860 that extends
towards distal surface 856. The distal surface 856 is configured to
be placed on the face 226 of the user to detect treatment locations
228 and to apply the treatment current.
[0105] In one embodiment, the handheld sinus treatment device 102
includes a dielectric covering 852 positioned on the conductive tip
108. The dielectric covering 852 is positioned on the conductive
tip 108 in such a way that a portion of the distal surface 856 is
covered by the dielectric covering 852 and a portion of the distal
surface 856 is uncovered by the dielectric covering 852. Thus,
according to an embodiment, the dielectric covering 852 defines a
covered portion 857 of the distal surface 856 and an exposed
portion 854 of the distal surface 856. The dielectric covering 852
also includes a distal surface 858 distal to the housing 106. The
distal surface 858 can also be considered a top surface of the
dielectric covering 852, according to one embodiment.
[0106] In one embodiment, the dielectric covering 852 is positioned
so that the distal surface 858 of the dielectric covering 852 is in
contact with the face 226 of the user when the exposed portion 854
is in contact with the face 226 of the user. Thus, while the user
uses the handheld sinus treatment device 102 to detect treatment
locations 228 and to apply the treatment current, both the exposed
portion 854 of the conductive tip 108 and the distal surface 858 of
the dielectric covering 852 are in contact with the face 226 of the
user.
[0107] In one embodiment, it can be beneficial for the treatment
current to have a high current density at the treatment location
228 such that the nerve node receives a high current density. In
order to promote a high current density at the treatment location
228, it is beneficial for a relatively small surface area of the
conductive tip 108 to contact the user's face 226 at the treatment
location 228. One way to ensure a relatively small surface area of
the conductive tip 108 contacts the user's face 226 during
treatment is to have a conductive tip 108 that is relatively sharp
at the point of contact. However, this can promote great discomfort
in the user. In some cases, such a sharp conductive tip 108 could
scratch, pierce, or otherwise induce pain or damage at the
treatment location 228.
[0108] In one embodiment, in order to avoid discomfort, the
conductive tip 108 includes a distal end 856 that is very gently
rounded such that the user does not experience discomfort when
placing the conductive tip 108 on the face 226 of the user. As set
forth above, without taking other measures, such a gently rounded
conductive tip 108 could decrease the current density at the
treatment location 228 because the larger surface area of the
conductive tip 108 would be in contact with the user's face
226.
[0109] In one embodiment, the presence and configuration of the
dielectric covering 852 enhances the comfort of the user while also
enabling a relatively high current density at the treatment
location 228 or nerve node. In particular, the distal surface 856
is rounded such that the distal surface 856 has a relatively low
radius of curvature. Nevertheless, the dielectric covering 852
covers a portion of the distal surface 858 such that during use of
the handheld sinus treatment device 102, only the exposed portion
854 of the distal surface 856 is in contact with the face 226 of
the user. The exposed portion 854 is rounded with a low radius of
curvature. The distal surface 858 of the dielectric covering 852
will also be in contact with the face 226 of the user during use of
the handheld sinus treatment device 102. Because only an exposed
portion 854 of the distal surface 856 is in contact with the face
226 of the user, relatively high current density is maintained
during the treatment mode at the treatment location 228. Because
the distal surface 856 is rounded, the user does not experience
discomfort when the conductive tip 108 is placed on the face 226 of
the user.
[0110] In FIG. 8, portions of the conductive tip 108 that are
covered by the dielectric covering 852 and the housing 106 are
shown in dashed lines.
[0111] In one embodiment, the dielectric covering 852 covers a
portion of the columnar portion 860 of the conductive tip 108. In
one embodiment, the housing 106 covers a columnar portion 860 of
the conductive tip 108. In one embodiment, the dielectric covering
852 is positioned on and in contact with the housing 106. In one
embodiment, the distal surface 858 of the dielectric covering 852
is rounded to promote comfort for the user while using the handheld
sinus treatment device 102.
[0112] In one embodiment, the conductive tip 108 includes a
material that is electrically conductive while having a lower
thermal conductivity than traditional electrical conductors such as
copper, gold, silver, iron, aluminum, titanium, and other common
metal alloys that are electrically conductive. Such traditional
conductive materials also have relatively high thermal
conductivities. Such high thermal conductivity can cause discomfort
when the material is placed on the skin of the user. If a material
with high thermal conductivity is relatively cold compared to the
skin of the user, the material will feel colder than would a
material with lower thermal conductivity but at the same
temperature as the material with higher thermal conductivity.
Likewise, if a material high thermal conductivity is relatively hot
compared to the skin of the user, the material will feel hotter on
the skin of the user than would a material with lower thermal
conductivity without the same temperature as the material of higher
thermal conductivity. Accordingly, in one embodiment, the
conductive tip 108 includes a material that is both electrically
conductive while having a relatively low thermal conductivity with
respect to traditional conductors.
[0113] In one embodiment, the conductive tip 108 includes a
conductive polymer. The conductive polymer has a low thermal
conductivity compared to typical electrical conductors. The
conductive polymer is also electrically conductive such that the
treatment current can be applied between the conductive tip 108 and
the return electrode 110. In one embodiment, the conductive polymer
includes one or more of polyacetylene, polyethylene vinylene,
polypyrrole, polythiophene, polyaniline, and polyphenylene sulfide.
Those of skill in the art will recognize, in light of the present
disclosure, that the conductive tip 108 can include other materials
that are electrical conductors with relatively low thermal
conductivity. All such other materials fall within the scope of the
present disclosure.
[0114] In one embodiment, the dielectric covering 852 includes a
plastic material. In one embodiment, the dielectric covering 852
includes a ceramic material. In one embodiment, the dielectric
covering 852 includes an epoxy material. In one embodiment, the
dielectric covering 852 includes a rubber material.
[0115] In one embodiment, the conductive tip 108 includes an
electrical conductor including one or more of aluminum, titanium,
gold, silver, iron, or other conductive metals, metal alloys, or
other kinds of conductive materials.
[0116] FIG. 9A is an illustration of a portion of a handheld sinus
treatment device 102 including a resilient member 966, according to
one embodiment. The resilient member 966 is coupled to the
conductive tip 108 and the housing 106 in such a way that the
conductive tip 108 resiliently depresses toward the housing 106
when pressure or force is applied to the conductive tip 108. When
the pressure or force is no longer applied to the conductive tip
108, the resilient member 966 returns to an equilibrium position,
thereby causing the conductive tip 108 return to the equilibrium
position.
[0117] In some cases, if a user accidentally presses the conductive
tip 108 against the skin of the user with too much force, the user
could feel discomfort at that location if the conductive tip 108 is
rigidly positioned relative to the housing 106. Accordingly, in
order to further enhance the comfort of the user, the handheld
sinus treatment device 102 includes the resilient member 966
coupled to the conductive tip 108 in the housing 106. When the user
presses the conductive tip 108 against the skin of the user, the
resilient member 966 flexes in a way that enables the conductive
tip 108 to depress toward the housing 106. Thus, if the user
accidentally applies a larger than normal amount of force when
pressing the conductive tip 108 against the skin, the user will not
experience discomfort because the conductive tip 108 will depress
downward due to the coupling with the resilient member 966.
[0118] In one embodiment, the resilient member 966 is positioned
within the housing 106. The resilient member 966 is in contact with
a portion of the conductive tip 108 that is also positioned within
the housing 106. The resilient member 966 is coupled to the
conductive tip 108 and configured to enable the conductive tip 108
to resiliently depress toward the housing 106. Because a portion of
the conductive tip 108 may be positioned within the housing 106,
depression of the conductive tip 108 toward the housing 106 can
correspond to a distal surface 856 or treatment surface of the
conductive tip 108 the pressing toward the housing 106.
[0119] In one embodiment, the resilient member 966 is positioned
external to the housing 106. For example, the resilient member 966
can be positioned on an upper surface of the housing 106 between
the housing 106 and the conductive tip 108. In this case,
electrical connections to the conductive tip 108 may couple to the
conductive tip 108 external to the housing 106. Because the
entirety of the conductive tip 108 may be positioned external to
the housing 106, depression of the conductive tip 108 toward the
housing 106 can correspond to depression of the entire conductive
tip 108 toward the housing 106.
[0120] In one embodiment, the resilient member 966 includes a
spring. When pressure is applied to the conductive tip 108, the
pressure causes the spring to compress such that the conductive tip
108 depresses or moves toward the housing 106. When the pressure is
no longer applied to the conductive tip 108, the spring
decompresses and the conductive tip 108 extends from the housing
106 to a rest position.
[0121] In one embodiment, the resilient member 966 includes a
flexible membrane. When pressure is applied to the conductive tip
108, the pressure causes the flexible membrane to deform in a
direction away from the face 226 of the user. The conductive tip
108 in turn depresses toward the housing 106. When the pressure is
no longer applied to the conductive tip 108, the flexible membrane
returns to an equilibrium position and the conductive tip 108
extends from the housing 106 toward an equilibrium position.
[0122] In one embodiment, the resilient member 966 includes an
elastic material. In one embodiment, the resilient member 966
includes rubber. Other resilient materials, configurations, and
structures can be selected for the resilient member 966 without
departing from the scope of the present disclosure.
[0123] FIGS. 9B and 9C are illustrations of a portion of handheld
sinus treatment device 102 including a spring 968, according to one
embodiment. The spring 968 is coupled to the housing 106 and the
conductive tip 108 in such a way that enables the conductive tip
108 to depress toward the housing 106 when pressure or force is
applied to the conductive tip 108. FIG. 9A is an illustration of
the handheld sinus treatment device 102 in a condition in which
external force or pressure is not applied to the conductive tip
108, such that the conductive tip 108 and the spring 968 are in
equilibrium position. FIG. 9B is an illustration of the handheld
sinus treatment device 102 in a condition in which external force
or pressure is applied to the conductive tip 108, such that the
spring 968 is compressed and the conductive tip 108 has depressed
toward the housing 106.
[0124] In one embodiment, the spring 968 is positioned internally
within the housing 106. Alternatively, the spring 968 can be
positioned external to the housing 106. For example, the spring 968
can be positioned on a top surface of the housing 106 between the
housing 106 and the conductive tip 108.
[0125] In one embodiment, the spring 968 is an electrical
conductor. The spring 968 can electrically couple the conductive
tip 108 sinus treatment circuitry positioned within the housing 106
such that when the treatment current passes through the conductive
tip 108, the treatment current also passes through the spring
968.
[0126] FIGS. 9D and 9E are illustrations of a portion of handheld
sinus treatment device 102 including a flexible membrane 970,
according to one embodiment. The flexible membrane 970 is coupled
to the housing 106 and the conductive tip 108 in such a way that
enables the conductive tip 108 to depress toward the housing 106
when pressure or force is applied to the conductive tip 108. FIG.
9D is an illustration of the handheld sinus treatment device 102 in
a condition in which external force or pressure is not applied to
the conductive tip 108, such that the conductive tip 108 and the
flexible membrane 970 are in equilibrium position. FIG. 9E is an
illustration of the handheld sinus treatment device 102 in a
condition in which external force or pressure is applied to the
conductive tip 108, such that the flexible membrane 970 is deformed
and the conductive tip 108 has depressed toward the housing
106.
[0127] In one embodiment, the flexible membrane 970 is positioned
internally within the housing 106. Alternatively, the flexible
membrane 970 can be positioned external to the housing 106. For
example, the flexible membrane 970 can be positioned on a top
surface of the housing 106 between the housing 106 and the
conductive tip 108.
[0128] In one embodiment, the flexible membrane 970 is an
electrical conductor. The flexible membrane 970 can electrically
couple the conductive tip 108 sinus treatment circuitry positioned
within the housing 106 such that when the treatment current passes
through the conductive tip 108, the treatment current also passes
through the flexible membrane 970.
[0129] FIG. 10 is a flow chart illustrating a process 1000 of
operating a sinus treatment device, according to an embodiment of
the disclosure.
[0130] At 1002, an impedance is detected between a conductive tip
and a return electrode of a sinus treatment device, according to
one embodiment.
[0131] At 1004, a treatment mode of the sinus treatment device is
initiated by passing a treatment current between the conductive tip
and the return electrode, according to one embodiment.
[0132] At 1006, a magnitude of the treatment current is gradually
increased during the treatment mode, according to one
embodiment.
[0133] FIG. 11 is a flow chart illustrating a process 1100 of
operating a sinus treatment device, according to an embodiment of
the disclosure.
[0134] At 1102, an impedance is detected between a conductive tip
and a return electrode of a sinus treatment device, according to
one embodiment.
[0135] At 1104, a treatment mode of the sinus treatment device is
initiated responsive to the impedance, according to one
embodiment.
[0136] At 1106, a treatment current including a series of current
spikes is passed between the conductive tip and the return
electrode during the treatment mode, according to one
embodiment.
[0137] At 1108, a magnitude of the current spikes is gradually
increased during the treatment mode until the magnitude reaches a
full treatment level, according to one embodiment.
[0138] In one embodiment, an initial stimulation voltage of the
treatment mode driven across the conductive tip (e.g., 108) and the
return electrode (e.g., 110) is a user selected stimulation voltage
received from a user input of the handheld sinus treatment device
(e.g., 102).
[0139] In one embodiment, a method includes initiating a haptic
feedback of the handheld sinus treatment device (e.g., 102) when
the treatment mode is initiated.
[0140] In one embodiment, a method includes illuminating a light
emitting diode of the handheld sinus treatment device (e.g., 102)
when the treatment mode is initiated.
[0141] In one embodiment, the return electrode (e.g., 110) is
attached to a body (e.g., 106) of the handheld sinus treatment
device (e.g., 102) that is formed to be held by a hand of a user of
the handheld sinus treatment device (e.g., 102) and the return
electrode (e.g., 110) is exposed to contact the hand of the user.
In one embodiment, the return electrode (e.g., 110) is included in
a body (e.g., 106) of the handheld sinus treatment device (e.g.,
102), and wherein the body (e.g., 106) includes conductive
polycarbonate to serve as the return electrode (e.g., 110).
[0142] In one embodiment, the process 1100 further includes turning
off the handheld sinus treatment device (e.g., 102) when the
impedance between the conductive tip (e.g., 108) and the return
electrode (e.g., 110) is over a pre-determined threshold for a
pre-determined time period (e.g., 2 minutes).
[0143] In one embodiment of the process 1100, driving the
stimulation voltage across the conductive tip (e.g., 108) and the
return electrode (e.g., 110) includes driving voltage pulses across
the conductive tip (e.g., 108) and the return electrode (e.g.,
110).
[0144] In one embodiment, the conductive tip (e.g., 108) is a
spring-loaded tip to reduce the pressure of the conductive tip
(e.g., 108) on a sinus skin area of the user of the handheld sinus
treatment device (e.g., 102). In one embodiment, the conductive tip
(e.g., 108) includes a conductor and a dielectric tip and both the
conductor and the dielectric tip contact a sinus skin area of the
user when the conductive tip (e.g., 108) is applied to the sinus
skin area of the user. In one embodiment, the conductor includes
carbon fiber.
[0145] In one embodiment, a method of operating a handheld sinus
treatment device (e.g., 102) includes measuring a stimulation
signal from a conductive tip (e.g., 108) of the handheld sinus
treatment device (e.g., 102) where the stimulation signal is
representative of a treatment current between the conductive tip
(e.g., 108) and a return electrode (e.g., 110) attached with a body
(e.g., 106) of the handheld sinus treatment device (e.g., 102). The
process further includes dynamically adjusting a stimulation
voltage across the conductive tip (e.g., 108) and the return
electrode (e.g., 110) to keep the treatment current at a constant
value in response to measuring the stimulation signal.
[0146] According to an embodiment, a method of operating a handheld
sinus treatment device (e.g., 102) includes detecting an impedance
between a conductive tip (e.g., 108) of the handheld sinus
treatment device (e.g., 102) and a return electrode (e.g., 110) of
the handheld sinus treatment device (e.g., 102). The method
includes initiating a treatment mode of the handheld sinus
treatment device (e.g., 102) when the impedance drops below a
threshold by applying a stimulation voltage between the conductive
tip (e.g., 108) and the return electrode (e.g., 110). The method
includes changing the stimulation voltage as the impedance between
the conductive tip (e.g., 108) and the return electrode (e.g., 110)
changes during the treatment mode.
[0147] According to an embodiment, a method includes applying, with
a handheld sinus treatment device (e.g., 102), sinus treatment
stimulation to a sinus treatment location (e.g., 228) of a user by
applying a treatment current between a conductive tip (e.g., 108)
and a return electrode (e.g., 110) of the handheld sinus treatment
device (e.g., 102). The method includes measuring a stimulation
signal representative of the treatment current and maintaining a
constant value of the treatment current during the treatment mode
by dynamically adjusting a stimulation voltage between the
conductive tip (e.g., 108) and the return electrode (e.g., 110) in
response to measuring the stimulation signal.
[0148] According to an embodiment, a method of operating a handheld
sinus treatment device (e.g., 102) includes initiating a treatment
mode of the handheld sinus treatment device (e.g., 102) by applying
a stimulation voltage between a conductive tip (e.g., 108) of a
handheld sinus treatment device (e.g., 102) and a return electrode
(e.g., 110) of the handheld sinus treatment device (e.g., 102). The
method includes changing the stimulation voltage as an impedance
between the conductive tip (e.g., 108) and the return electrode
(e.g., 110) changes during the treatment mode.
[0149] According to an embodiment, a handheld sinus treatment
device (e.g., 102) includes a conductive tip (e.g., 108), a return
electrode (e.g., 110) operatively coupled to a body (e.g., 106) of
the handheld sinus treatment device (e.g., 102), and a stimulation
driver stage coupled to apply a stimulation voltage between the
conductive tip (e.g., 108) and the return electrode (e.g., 110).
The handheld sinus treatment device (e.g., 102) includes a peak
detector coupled to generate a peak treatment current signal in
response to receiving a stimulation signal from the conductive tip
(e.g., 108). The handheld sinus treatment device (e.g., 102)
includes a microcontroller (e.g., 434) coupled to receive the peak
treatment current signal from the peak detector and coupled to the
stimulation driver stage for adjusting the stimulation voltage in
response to the peak treatment current signal. The microcontroller
(e.g., 434) dynamically adjusts the stimulation voltage to keep the
peak treatment current signal at a constant value.
[0150] According to an embodiment, a handheld sinus treatment
device (e.g., 102) includes a body (e.g., 106) configured to be
held in a hand of user, a conductive tip (e.g., 108) coupled to the
body (e.g., 106), and a return electrode (e.g., 110) positioned on
the body (e.g., 106) such that when a user holds the body (e.g.,
106) the hand of the user is in contact with the return electrode
(e.g., 110). The handheld sinus treatment device (e.g., 102)
includes sinus treatment circuitry positioned within the body
(e.g., 106) and configured to detect an impedance between the
conductive tip (e.g., 108) and the return electrode (e.g., 110) and
to enter a treatment mode responsive to the impedance dropping
below a threshold by applying a treatment current between the
conductive tip (e.g., 108) and the return electrode (e.g.,
110).
[0151] According to an embodiment, a method includes detecting,
during a detection mode, an impedance between a conductive tip
(e.g., 108) of a sinus treatment device (e.g., 102) and a return
electrode (e.g., 110) of the sinus treatment device (e.g., 102).
The method includes initiating a treatment mode of the sinus
treatment device (e.g., 102) when the impedance drops below a
threshold including passing a treatment current between the
conductive tip (e.g., 108) and the return electrode (e.g., 110).
The treatment current includes a series of current spikes (e.g.,
650).
[0152] According to an embodiment, a method includes detecting,
during a detection mode, an impedance between a conductive tip
(e.g., 108) of the sinus treatment device (e.g., 102) and a return
electrode (e.g., 110) of the sinus treatment device (e.g., 102).
The method includes initiating a treatment mode of the sinus
treatment device (e.g., 102) when the impedance drops below a
threshold including passing a treatment current between the
conductive tip (e.g., 108) and the return electrode (e.g., 110).
The treatment current has a magnitude less than 1000 .mu.A.
[0153] The processes explained above are described in terms of
computer software and hardware. The techniques described may
constitute machine-executable instructions embodied within a
tangible or non-transitory machine (e.g., computer) readable
storage medium, that when executed by a machine will cause the
machine to perform the operations described. Additionally, the
processes may be embodied within hardware, such as an application
specific integrated circuit ("ASIC") or otherwise.
[0154] A tangible non-transitory machine-readable storage medium
includes any mechanism that provides (i.e., stores) information in
a form accessible by a machine (e.g., a computer, network device,
personal digital assistant, manufacturing tool, any device with a
set of one or more processors, etc.). For example, a
machine-readable storage medium includes recordable/non-recordable
media (e.g., read only memory (ROM), random access memory (RAM),
magnetic disk storage media, optical storage media, flash memory
devices, etc.).
[0155] FIG. 12 shows several views of a microcurrent sinus
treatment device 1200, according to an embodiment.
[0156] The inventors note that the device described herein includes
several features intended to provide a positive user
experience.
[0157] With respect to structure, a therapeutic tip may include a
screw thread to hold a case together with no external screws.
[0158] According to an embodiment, a device includes a metal or
metal-coated plastic return electrode on a case structure portion
that occupies an area selected to make it nearly impossible for a
user to hold the device without completing a circuit. In an
embodiment, the device uses metal-plated plastic. In an embodiment,
the device uses punched aluminum for the exposed portion of the
return electrode.
[0159] Referring to FIG. 12, according to an embodiment, a
microcurrent sinus treatment device 1200 includes a circuit
configured to deliver a sequence of voltage pulses carrying a
therapeutic current, and a therapeutic electrode 1204 operatively
coupled to the circuit. In an embodiment, the therapeutic electrode
1204 may be configured to apply the sequence of voltage pulses to a
user's skin surface adjacent to one of a plurality of nerve nodes
subjacent to the user's skin surface. In an embodiment, the
therapeutic electrode 1204 may be in electrical continuity with a
therapeutic current output node of the circuit. According to an
embodiment, the microcurrent sinus treatment device 1200 includes a
hand holdable case 1206 configured to substantially contain active
portions of the circuit. In an embodiment, the hand holdable case
1206 includes a forward end 1208 terminating in the therapeutic
electrode 1204, and a return electrode 1210 comprising a portion of
or disposed on a surface of the hand holdable case 1206. In an
embodiment, the return electrode 1210 may be in electrical
continuity with a current return node of the circuit. In an
embodiment, the hand holdable case 1206 includes a dielectric
spacer 1212 disposed between the therapeutic electrode 1204 and the
return electrode 1210, and a rearward portion 1214 of the hand
holdable case 1206 terminating at an end 1220 a distance selected
to comfortably fit in an adult human hand, typically less than
about four inches from the therapeutic electrode 1204 tip. In an
embodiment, the dielectric spacer 1212 and the return electrode
1210 form a tapered surface 1216 narrowing toward the therapeutic
electrode 1204 from a point of maximum girth disposed between the
forward end 1208 and the rearward end 1220 of the hand holdable
case 1206.
[0160] According to an embodiment, the therapeutic electrode 1204
is configured to clamp the return electrode 1210 against the
rearward portion 1214 of the hand holdable case 1206 to hold the
dielectric spacer 1212 and the return electrode 1210 together with
the rearward portion 1214 of the hand holdable case 1206. In an
embodiment, the therapeutic electrode 1204 includes a threaded
portion configured to screw into a hole (not shown) formed inside
the rearward portion 1214 of the hand holdable case 1206. In
another embodiment, the placement of the therapeutic electrode
1204, the dielectric spacer 1212, and the return electrode 1210 are
configured to cause the user's body to complete a circuit between
the therapeutic electrode 1204 and the return electrode 1210.
[0161] In an embodiment, the tapered case is adaptable to a large
range of hand sizes. In an embodiment, the rearward end 1220 of the
hand holdable case 1206 is less than three inches from the
therapeutic electrode 1204 tip. In an embodiment, the tapered
surface 1216 is conducive to cause the user's hand to naturally
contact the return electrode 1210. In an embodiment, the tapered
surface 1216 is conducive to provide satisfactory control for
holding the therapeutic electrode 1204 against the user's skin
superjacent to each of the plurality of nerve nodes.
[0162] According to an embodiment, in FIG. 12, the hand holdable
case 1206 forms a surface having an indentation larger than an
average user's thumb on a back side of the hand holdable case 1206
such that a front portion of the indentation extends toward the
therapeutic electrode 1204 and away from the point of maximum girth
of the hand holdable case 1206. In one embodiment, the indentation
is disposed with at least a majority of its area between the
therapeutic electrode 1204 and the point of maximum girth. In
another embodiment, the indentation is disposed partially extending
beyond the point of maximum girth toward the rearward end 1220 of
the hand holdable case 1206.
[0163] According to an embodiment, the dielectric spacer 1212
defines a concave insulated surface near the therapeutic electrode
1204 to make clearance for the user's cheek and/or nose.
[0164] According to an embodiment, the hand holdable case 1206
defines a tapered surface on a top, between the point of maximum
girth and the forward end 1208, configured to provide a finger
hold. In an embodiment, the tapered surface forms a facet relative
to other portions of the top.
[0165] According to an embodiment, the hand holdable case 1206
defines a convex curved surface, on the top between the point of
maximum girth and the rearward end 1220, configured to fit into a
hollow of the user's palm.
[0166] According to a embodiment, the hand holdable case 1206
defines a tapered side 1216 to accommodate finger placement.
[0167] According to an embodiment, the hand holdable case 1206
further comprises a light pipe 1228 disposed between the forward
end 1208 and the return electrode 1210, the light pipe 1228 being
configured to output an illumination indicator from a light
emitting diode (LED) disposed on the circuit to indicate an
operating condition to the user.
[0168] According to an embodiment, the microcurrent sinus treatment
device 1200 further includes a button 1230 configured to cause the
circuit to enter a low current, nerve node finding mode, the
circuit being further configured to enter a high current
therapeutic voltage pulse mode when a nerve node is found and to
automatically shut off when a dose of therapeutic voltage pulses
have been delivered.
[0169] According to an embodiment, the therapeutic electrode 1204
may be configured to maximize comfort for the user. This may be
accomplished by keeping a diameter and radius of the therapeutic
electrode 1204 tip at the forward end 1208 of the case large enough
to avoid applying undue pressure against the user's skin. The
inventors have found that maximizing the diameter and radius for
comfort should be balanced against localization of current flow
across the user's skin. In an embodiment, the exposed portion of
the therapeutic electrode 1204 may have a diameter greater than or
equal to 1/16 of an inch (0.0625'') ( 1/32''=0.031'' radius) and
less than 1/4'' (0.25'') diameter (1/8''=0.125'' radius). In
another embodiment, the exposed portion of the therapeutic
electrode 1204 may have a diameter greater than or equal to 3/32''
(=0.094'') ( 3/64''=0.047'') and less than or equal to 3/16''
(0.188'') diameter and 3/32''=0.094'' radius. In another
embodiment, the exposed portion of the therapeutic electrode 1204
may have a diameter equal to about 5/32'' (0.16'') and 5/64''
(0.078'' radius). Relevant dimensions, according to an embodiment,
are shown in FIG. 5.
[0170] According to embodiments, the inventors have noted three
primary ways users may hold the device:
[0171] 1. Thumb directed--the user puts his/her thumb in the
indentation and points toward the user's face. The user's fingers
wrap around the hand holdable case 1206.
[0172] 2. Finger directed--the user places his/her index finger on
the tapered surface 1216 and points toward the user's face. The
user's fingers and thumb wrap around the hand holdable case
1206.
[0173] 3. Hybrid--the user places his/her thumb on the indentation
and places his/her index finger on the side, both thumb and index
finger point toward the user's face. The user's middle finger
stabilizes along the front. (Some users were found to be unable to
use this technique.)
[0174] All three approaches are amenable to right-handed or
left-handed use. Users naturally fell into one of the three grips.
Features on the hand holdable case 1206 enable one or more of the
grips.
[0175] While various aspects and embodiments have been disclosed
herein, other aspects and embodiments are contemplated. The various
aspects and embodiments disclosed herein are for purposes of
illustration and are not intended to be limiting, with the true
scope and spirit being indicated by the following claims.
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