U.S. patent application number 16/181851 was filed with the patent office on 2019-11-21 for dry eye treatment device.
The applicant listed for this patent is Michael Lutz, Michael C. Whitehurst. Invention is credited to Michael Lutz, Michael C. Whitehurst.
Application Number | 20190350750 16/181851 |
Document ID | / |
Family ID | 54366821 |
Filed Date | 2019-11-21 |
United States Patent
Application |
20190350750 |
Kind Code |
A1 |
Whitehurst; Michael C. ; et
al. |
November 21, 2019 |
DRY EYE TREATMENT DEVICE
Abstract
A dry eye treatment device and method of use are disclosed for
applying heat to the exterior surface of an eyelid to treat dry eye
symptoms which can be caused by meibomian gland dysfunction (MGD).
More specifically, a user operable main unit and hand piece are
provided that allow the user to heat his/her or another patient's
eyelids to a desired temperature, which can effectively and
efficiently raise the temperature at the meibomian glands
sufficient to melt, loosen, or soften more serious occlusions or
obstructions in the meibomian glands, thereby restoring natural
secretory function to obstructed glands.
Inventors: |
Whitehurst; Michael C.;
(Dallas, TX) ; Lutz; Michael; (Brandon,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Whitehurst; Michael C.
Lutz; Michael |
Dallas
Brandon |
TX
FL |
US
US |
|
|
Family ID: |
54366821 |
Appl. No.: |
16/181851 |
Filed: |
November 6, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14451363 |
Aug 4, 2014 |
10130507 |
|
|
16181851 |
|
|
|
|
61861998 |
Aug 3, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2007/0004 20130101;
A61F 2007/0086 20130101; A61F 2007/0219 20130101; A61F 2007/0075
20130101; A61F 7/007 20130101; A61F 2007/0076 20130101; A61F 9/00
20130101; A61F 7/08 20130101; A61F 2007/0087 20130101; A61F
2007/0093 20130101 |
International
Class: |
A61F 7/00 20060101
A61F007/00; A61F 7/08 20060101 A61F007/08 |
Claims
1. A method of treating an eye with an eye treatment device,
comprising: heating an end piece of a hand-held unit; placing the
end piece on an exterior surface of an eyelid; and moving the end
piece on the exterior surface of the eyelid.
2. The method of claim 1, wherein the end piece is heated by a
heating element disposed within the hand hand-held unit.
3. The method of claim 1, further comprises applying a substance to
the exterior surface of the eyelid.
4. The method of claim 1, wherein the substance is an ultrasound
gel.
5. The method of claim 1, wherein the treating further comprises
promoting meibomian gland function of the eyelid.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. Non-Provisional
application Ser. No. 14/451,363 filed on Aug. 4, 2014, which is
incorporated herein by reference in its entirety, which claims the
benefit of U.S. Provisional Application No. 61/861,998 filed on
Aug. 3, 2013, which is incorporated herein by reference in its
entirety.
FIELD
[0002] The present invention relates generally to the field of
ophthalmology. More particularly, the present invention relates to
treatment of meibomian gland dysfunction (MGD), which may be either
responsible for or be a contributing factor to a patient suffering
from a "dry eye" condition.
BACKGROUND
[0003] This section is intended to introduce the reader to aspects
of art that may be related to various aspects of the present
invention, which are described and/or claimed below. This
discussion is believed to be helpful in providing the reader with
background information to facilitate a better understanding of the
various aspects of the present invention. Accordingly, it should be
understood that these statements are to be read in this light, and
not as admissions of prior art.
[0004] Dry eye or irritated eye symptoms typically result from an
insufficiently lubricated ocular surface of the eye, which can be
caused by a change or reduction in the composition of a lipid
component of a tear film coating of the eye. These changes in the
lipid layer are often the result of obstructive meibomian gland
dysfunction (MGD), a form of posterior blepharitis that results in
changes to the local eyelid margin. In particular, obstruction of
the meibomian glands may decrease delivery of meibomian gland
secretions, which include various oil and lipid components
typically secreted from the meibomiam glands upon blinking.
[0005] Meibomian glands, also known as tarsal glands, are meibum
secreting sebaceous glands located at the eyelid rim. The meibomian
glands are found on both the upper and lower lids and produce a
holocrine lipid secretion that constitutes the surface layer of the
preocular tear film. This lipid surface layer helps produce a
smooth optical surface, reduces evaporation, and reduces
contamination by skin surface lipids.
[0006] The aforementioned MGD may arise from one or more meibomiam
gland ducts becoming plugged or partially plugged with meibomiam
gland products such as lipids and oils. Due to various factors,
these lipids and oils may solidify thereby plugging the gland
ducts. As a result of the plugging and solidification, sufficient
meibomiam oils and lipids may not be expressed onto the tear film.
In addition, secretory product and bacteria may also build up
within the gland.
[0007] Hence, what is needed is an effective and easy to use device
capable of unplugging severely plugged meibomiam gland ducts of the
eye thereby relieving a patient of MGD. The dry eye treatment
device of the present invention addresses one or more of the
concerns set forth above.
BRIEF SUMMARY
[0008] In one aspect of the present invention, a dry eye treatment
device and method of use are disclosed for applying heat to the
exterior surface of the eyelid to treat dry eye caused by meibomian
gland dysfunction (MGD). More specifically, a user operable main
unit and hand piece are provided that allow the user to heat
his/her or another user/patient's eyelids to a desired temperature,
which can effectively and efficiently raise the temperature at the
meibomian glands to a temperature sufficient to melt, loosen, or
soften more serious occlusions or obstructions in the meibomian
glands, and restore natural secretory function to obstructed
glands. Further, the eye treatment device of the present invention
is user programmable, simple to operate and use, cost effective to
manufacture, and can effectively treat MGD without additional
surgical operations, devices, or pharmaceutical drugs.
[0009] In another aspect of the present invention, an eye treatment
device is provided having a heating element disposed within a
hand-held unit, and wherein the heating element is coupled to an
eyelid applicator. The eyelid applicator is configured to apply
heat to an exterior surface of one or more eyelids. In addition, a
controller can be in communication with the heating element,
wherein the controller is configured to regulate a temperature of
the heating element. In addition, the eyelid applicator can further
include a partially curved surface. In addition, the heating
element and eyelid applicator are part of a hand-held unit.
Further, the controller can be disposed within a main unit, wherein
the main unit is coupled to the hand-hand unit. Also, the eyelid
applicator can be further coupled to a thermal transfer rod,
wherein the rod is further coupled to the heating element. The
thermal transfer rod can be at least partially bent. Further, the
heating element is a Peltier device.
[0010] In another aspect of the present invention, an eye treatment
device is provided having a hand-held unit having a heating
element, wherein the heating element is further coupled to an end
piece, and wherein the end piece is configured to transfer heat to
one or more eyelids. The device can further include a main
stationary unit, wherein the main unit communicates with the
hand-held unit. Here, the main unit can regulate a temperature of
the heating element. In addition, the main unit can further include
a user interface display, wherein the user interface display is
configured to control operation of the hand-held unit.
[0011] In another aspect of the present invention, a method of
treating an eye with an eye treatment device is provided. The
method includes heating an end piece of a hand-held unit,
positioning the heated end piece on an exterior surface of an
eyelid, and moving the end piece on the exterior surface of the
eyelid. Here, the end piece is heated by a heating element disposed
within the hand hand-held unit. The method can further include
applying a substance to the exterior surface of the eyelid, wherein
the substance is an ultrasound gel. In addition, moving the end
piece on the exterior surface of the eyelid promotes meibomian
gland function of the eyelid.
[0012] The above summary is not intended to describe each and every
disclosed embodiment or every implementation of the disclosure. The
Description that follows more particularly exemplifies the various
illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The following description should be read with reference to
the drawings, in which like elements in different drawings are
numbered in like fashion. The drawings, which are not necessarily
to scale, depict selected embodiments and are not intended to limit
the scope of the disclosure. The disclosure may be more completely
understood in consideration of the following detailed description
of various embodiments in connection with the accompanying
drawings, in which:
[0014] FIG. 1 illustrates a perspective view of an embodiment for
the eye treatment device of the present invention.
[0015] FIG. 2 illustrates a top view of the eye treatment device
for the embodiment of FIG. 1.
[0016] FIG. 3 illustrates a rear view of an embodiment for the eye
treatment device of the present invention.
[0017] FIG. 4 illustrates a top view for an embodiment of the
internal components for the eye treatment device of the present
invention.
[0018] FIG. 5 illustrates a schematic electrical diagram for an
embodiment of the eye treatment device of the present
invention.
[0019] FIG. 6 illustrates a side perspective view of an embodiment
for a hand piece or applicator of the eye treatment device of the
present invention.
[0020] FIG. 7 illustrates a side perspective view for another
embodiment for a hand piece or applicator of the eye treatment
device of the present invention.
[0021] FIG. 8 illustrates a side perspective view for another
embodiment for a hand piece or applicator of the eye treatment
device of the present invention.
[0022] FIG. 9 illustrates a side perspective view for another
embodiment for a hand piece or application of the eye treatment
device of the present invention.
[0023] FIG. 10 illustrates a perspective side view for another
embodiment for a hand piece or application of the eye treatment
device of the present invention.
[0024] FIG. 11 illustrates a front view for an embodiment for an
eye contact part for the hand piece of the eye treatment device of
the present invention.
[0025] FIG. 12 illustrates a top view for the eye contact component
of FIG. 11.
[0026] FIG. 13 illustrates a side view for the eye contact part and
thermal transfer rod of FIG. 11.
[0027] FIG. 14 illustrates a front view for another embodiment for
a double tip eye contact part for the hand piece of the eye
treatment device of the present invention.
[0028] FIG. 15 illustrates a top view for the embodiment of FIG.
14.
[0029] FIG. 16 illustrates a perspective view of the internal
components for the hand piece or applicator of the eye treatment
device of the present invention.
[0030] FIG. 17 illustrates a cross-sectional side view of the hand
piece for the eye treatment device of the present invention.
[0031] FIG. 18 illustrates another close-up cross-sectional side
view of the hand piece or applicator for the eye treatment device
of the present invention.
[0032] FIG. 19 illustrates a top view for a home screen display for
an embodiment of the eye treatment device of the present
invention.
[0033] FIGS. 20-22 illustrates a top view for an operational screen
display for an embodiment of the eye treatment device of the
present invention.
[0034] FIG. 23 illustrates a perspective view of a patient and user
for a method of use of the eye treatment device of the present
invention.
[0035] FIG. 24 illustrates a close-up perspective view of the
patient's eyelid and eyelid contact part for the embodiment of FIG.
23.
DETAILED DESCRIPTION
[0036] In the Brief Summary of the present disclosure above and in
the Detailed Description of the Invention, and the claims below,
and in the accompanying drawings, reference is made to particular
features (including method steps) of the invention. It is to be
understood that the disclosure of the invention in this
specification includes all possible combinations of such particular
features. For example, where a particular feature is disclosed in
the context of a particular aspect or embodiment of the invention,
or a particular claim, that feature can also be used, to the extent
possible, in combination with and/or in the context of other
particular aspects and embodiments of the invention, and in the
invention generally.
[0037] The embodiments set forth below represent the necessary
information to enable those skilled in the art to practice the
invention and illustrate the best mode of practicing the invention.
In addition, the invention does not require that all the
advantageous features and all the advantages need to be
incorporated into every embodiment of the invention.
[0038] Phrases and terms similar to "software", "application",
"algorithm", and "firmware" may include any non-transitory computer
readable medium storing thereon a program, which when executed by a
computer, causes the computer to perform a method or function.
[0039] Phrases and terms similar to "network" may include one or
more data links that enable the transport of electronic data
between computer systems and/or modules. When information is
transferred or provided over a network or another communications
connection (either hardwired, wireless, or a combination of
hardwired or wireless) to a computer, the computer uses that
connection as a computer-readable medium. Thus, by way of example,
and not limitation, computer-readable media can also comprise a
network or data links which can be used to carry or store desired
program code in the form of computer-executable instructions or
data structures and which can be accessed by a general purpose or
special purpose computer.
[0040] In one aspect of the present invention, a device and method
are disclosed for applying heat to the exterior surface of one or
more eyelids to treat dry eye caused by meibomian gland dysfunction
(MGD). Applying heat to the exterior of the eyelid can effectively
and efficiently raise the temperature at the meibomian glands to a
temperature sufficient to melt, loosen, or soften more serious
occlusions or obstructions in the meibomian glands. The occlusions
or obstructions can then be physically expressed to improve sebum
flow from the meibomian glands to reduce evaporation of the aqueous
layer.
[0041] FIG. 1-2 illustrates a perspective view and top view of one
embodiment for the dry eye treatment device of the present
invention. Specifically, the dry eye treatment device 100 includes
a controller or main unit 102 having a housing or casing, and
wherein the main unit 102 is connected to a hand piece, or
hand-held unit applicator 200 via electrical cord, cable, or tubing
250. Here, main unit 102 includes a user interface display 104, a
key lock 108 with key, a light indicator 106, and holder arms 110
for holding or docking hand piece 200. Referring, to FIG. 3, main
unit 102 includes a top half housing 102a and a bottom half housing
102b coupled to each other. In addition, main unit 102 includes an
electrical outlet socket 116 for powering the eye treatment device
100, wherein the outlet can be connected to any type of standard
electrical wall outlet, such as 110V, 220V, 120V, or 240V outlets.
Alternatively, the main unit and hand piece can be powered via one
or more batteries, wherein each of main unit 102 and hand piece 200
can include battery packs. Further, the main unit is outfitted with
a cooling fan 112 for cooling the internal components of the
housing. In addition, outlet 114 connects hand piece 200 with main
unit 102 via cord 250. Outlet 118 can be a factory service port for
running diagnostic testing, programming, or upgrading, changing, or
modifying the software, firmware, applications, hardware, and
internal components for the eye treatment device 100.
[0042] FIG. 4 illustrates a top view for the internal hardware
components for the man unit 102 of the eye treatment device 100.
More specifically, here top half casing 102a has been removed.
Here, main unit 102 generally includes I/O board 124, thermal
controller 128, central processing unit (CPU) 126, 3.3 v LVPS power
supply 122, and 12 v LVPS power supply 120. Here, the
aforementioned components can include one or more processors
adapted to operate in accordance with one or more algorithms that
can control or at least partially control one or more components of
the device as further shown in FIG. 5, including but not limited to
display 104, heating and cooling elements, sensors, thermocouples,
timers, and hand piece applicator of the eye treatment device,
among others.
[0043] FIG. 5 illustrates a detailed electrical schematic diagram
for the communication and connections between the components of the
eye treatment device. More specifically, main controller or I/O
board 124 is shown communicating with CPU 126, which communicates
and controls and operates display 104. The display 104 can be a
touchscreen display that function's as both a display and keypad or
user input device. In some instances, a display can include or may
be a liquid crystal display (LCD), high performance addressing
display (HPA), thin film transistor display (TFT), light emitting
diode (LED), organic light emitting diode (OLED), or an image (or
moving image) projector. In the current embodiment, the touch
screen panel can be adapted to solicit values for a number of
operating parameters and/or to receive said values. In addition,
the display screen may provide haptic feedback to a user.
[0044] Still referring to FIG. 5, I/O board 124 further
communicates with temperature controller 128 connected to a
calibration port. I/O board 124 further communicates with the
components of hand piece 200, namely, at least two thermocouples
(thermistors), LED light indicator, and Peltier device or TEC
thermoelectric device 212. Here, in one embodiment, main unit 102,
and other internal components. The I/O board 124 can be powered by
a 12 v LVPS (low voltage power supply) unit 124 and handpiece 200
(including its internal components) can be powered by a 3 v LVPS
power supply. However, it is contemplated within the scope of the
invention that any type or any number of power supplies may be used
to power any one or more components of eye treatment device.
[0045] FIG. 6 illustrates an embodiment for the hand piece 200 of
the eye treatment device. Here, Specifically, hand piece 200
includes an eyelid applicator or end piece 300 that includes an
eyelid contact component 304 that is coupled to or integrated with
a thermal transfer rod 302 and wherein the transfer rod 302 is
secured and engaged within bullet shaped distal end piece or cap
204, and further wherein end piece 204 further secures rod 302.
Here, end piece 204 can be fixed or removable and can be threadably
engaged with and connected to main cylindrical or tubular body
component 202, wherein body 202 at least partially houses the
internal components of hand piece 200. Hand piece 200 further
includes a removable or fixed end cap or base 206 coupled to main
body 202. End cap 206 includes an annular opening for receiving
tubing 250. Here, in one embodiment, end cap can be a clear or
colored transparent or semi-transparent component that can be
illuminated via a light indicator 210 (FIGS. 16-18). In another
embodiment, the entire hand piece can be a clear or colored
transparent or semi-transparent material that can be illuminated.
In other embodiments, any one or more parts of hand piece can be
solid or opaque components. In one embodiment, one or more of the
aforementioned parts for hand piece 200 can be made of one or more
metals, aluminum, silver, stainless steel, plastic, acrylics,
copper, heat resistant material, and heat absorbing material, among
others. In further embodiments, any one or more components 202,
204, 206, 300, 302, and 304 can either be independent parts or
integrated with one or more other parts, or all parts 202, 204,
306, 300, 302, and 304 can be one unitary piece. Alternatively,
part 300 (collectively 302 and 304) can be the only removable and
interchangeable parts of hand piece 200. In such an embodiment,
parts 302 and 304 are integrated and fixed to each other. However,
it is contemplated within the scope of the invention that either
one or more of parts 302 and 304, individually or combined, can be
interchangeable.
[0046] FIGS. 7-10 illustrate various embodiments for the end piece
or eyelid applicator having an eyelid contact component
configurations and thermal transfer rod orientations for the hand
piece 200 of the eye treatment device. Specifically, FIG. 7
illustrates a thermal transfer rod 322 having a slightly or
partially bent configuration, preferably a 30-degree angle with
respect to a horizontal plane. The bent configuration of the rod
allows for a more natural position of the hand-held unit 200 by a
user during a treatment session. However, it is contemplated within
the scope of the invention that the bend in rod 322 or any of rods
302, 332, 342, and 352 can be anywhere from 1-degree up to and
include 90-degrees. Still referring to FIG. 7, rod 322 is shown
further coupled to or integrated with the at least partially arched
or concave single tip eyelid contact piece 304 (FIGS. 11-13). FIG.
8 illustrates a thermal transfer rod 332 in a straight
configuration or parallel with respect to a horizontal plane,
wherein rod 332 is further coupled to or integrated with eyelid
contact piece 304. FIG. 9 illustrates an embodiment for a slightly
or at least partially bent thermal transfer rod 342 coupled to or
integrated with an at least partially arched or concave surface
double tip eyelid contact piece 344 (FIG. 14). FIG. 10 illustrates
another embodiment for a slight curved or at least partially curved
or bent thermal transfer rod 352 coupled to or integrated with an
at least partially concave surface double tip eyelid contact piece
344 (FIG. 14). Here, eyelid applicator 300, including any of parts
302, 304, 322, 332, 342, and 344 can be rigid components; however,
it is contemplated within the scope of the invention that they can
also be flexible.
[0047] FIGS. 11-13 illustrates various views for an embodiment of
the end piece 300 and eyelid contact piece 304. Here, piece 300 is
generally shown having a "T" shaped configuration that allows it
make contact with the upper or lower human eyelid. Eyelid contact
tip piece 304 is shown as a single contact tip component having a
partially or slightly concave, arched, or curved outer surface
304a. Here, curvilinear, curved, arched, or concave surface 304a is
configured as such to accommodate the convex shape of a closed
human upper or lower eyelid in order to make partial or substantial
contact with the exterior surface of the closed upper or lower
eyelids. Rod 302 includes a threaded end that allows piece 300 (rod
302 and tip 304) to be removable and interchangeable with hand
piece 200. Here, the threaded end of rod 302 can be threaded into
cap 204. It is contemplated within the scope of the invention that
tip 304 may also be coupled to or integrated with any of the
aforementioned rods 302, 322, or 332 of the eye treatment
apparatus.
[0048] FIGS. 14-15 illustrate various views for another embodiment
for end piece 300 and double tip eyelid contact piece 344. Here,
piece 344 is generally shown having a "T" shaped configuration that
allows it make contact with the upper or lower human eyelid. Eyelid
contact tip piece 344 is shown as a dual or double contact tip
component wherein each tip has a first and second outer surfaces
344a and 344b having a partially or slightly concave outer surface.
Here, concave or curved surfaces 344a and 344b are configured as
such to accommodate the convex shape of a human upper or lower
eyelid in order to make partial or substantial contact with the
exterior surface of the closed upper or lower eyelids. Rod 302
includes a threaded end 302a that allows piece 300 (rod 302 and tip
304) to be removable and interchangeable with hand piece 200. In
one embodiment, the threaded end can engage cap 204 and/or heat
block 218. It is contemplated within the scope of the invention
that tip 304 may also be coupled to or integrated with any of the
aforementioned rods 302, 322, or 332 of the eye treatment
apparatus.
[0049] FIG. 16 illustrates some of the interior components of hand
piece 200 with the main body or sleeve 202, cap 204, and eyelid
applicator 300 removed. Here, fiberglass wrap 252 securely encloses
parts 212, 214, and 218 (FIG. 17) of the hand piece. Also shown is
LED or light source 210 that allows end cap 206 to be illuminated
during operation for the eye treatment device, which will later be
described in detail.
[0050] FIG. 17 illustrates a partial cross-sectional side view for
hand piece 200. Specifically, hand piece 200 includes a Peltier
element, thermoelectric cooling (TEC), heating element, or Peltier
device 212, which is generally a solid-state active heat pump that
transfers heat from one side of the device to the other, with
consumption of electrical energy, depending on the direction of the
current. In the current embodiment, Peltier device 212 can operate
as a generator wherein one side of the device is heated to a
temperature greater than the other side, and as a result, a
difference in voltage is built up between the two sides. Peltier
device 212 can achieve a thermoelectric effect, Peltier effect,
Seabeck effect, or Thomson effect. For example, in one embodiment,
the Peltier device of the hand piece can be comprised of both a
cylindrical or circular hot side and cylindrical or circular cold
side adjacent to each other and connected to each other via two
thermo electrical legs. However, it is contemplated within the
scope of the invention that the Peltier device 212 can take any
shape, dimension, or configuration, including but not limited to
square, plates, rectangular, oval, ellipsoid, or circular.
[0051] Still referring to FIG. 17, Peltier device 212 is further
connected to a cold block 214 and copper heat block 218. Heat block
218 is further connected to thermal transfer rod 302, which is
further connected to eyelid contact piece 304. Heat block 218 can
further amplify the heating effect on transfer rod 302, whereas
cold block 214 can assist in dissipating heat from Peltier 212 when
in heating mode. Here, Peltier 212 operates to heat eyelid contact
applicator piece 304. In addition, a thermal compound 220 or a high
"R" insulation foam is provided to insulate the shaft, end piece
204, and main body 202 of the hand piece 200. Here, the thermal
compound can be distributed through the interior space 201 of hand
piece 200. In addition, a wire support bar 216 is provided for
supporting and securing various wiring.
[0052] Referring now to FIG. 17 and FIG. 18, cable tubing or cord
250 includes a plurality of wiring for powering, sensing, and
operating a plurality of internal components of hand piece. Here,
wiring within cord 250 is further connected to main unit 102, and
more specifically the I/O board 124 (FIG. 5) which at least
partially controls operation for Peltier 212, thermocouples 234 and
232, and LED light source 210, among others. In the current
embodiment, wiring 224, 226, 228, and 210a are disposed within cord
tubing 250 and further connected to main unit 102. Specifically,
wiring 226 is configured to power, operate, and heat Peltier 212.
Heat block 218 of Peltier 212 is further connected to and/or
integrated with thermocouples or thermistors 232 and 234 on
opposing sides of heat block 218. Here, thermocouples 232 and 234
communicate and transfer temperature data via wiring 228 and 224,
respectively, back to main unit 102 and more specifically I/O board
124 (FIG. 5). Here, thermocouples 232 and 234 operate to regulate
temperature for Peltier 212 and further error checking each other.
More specifically, Peltier 212 is pre-programmed (or set by a user)
to operate at a certain temperature within a temperature range and
thermocouples 232 and 234 operate to regulate this temperature via
communicating with the temperature controller 128, I/O board 124,
and controller/main unit 102. For example, temperature controller
128 can regulate the temperature of Peltier 212 at a constant
pre-defined temperature. In addition, wiring 210a powers and
operates LED light source 210, wherein source 210 can further
illuminate base 206. For example, in one embodiment, light source
210 can be in a blinking or flashing mode while Peltier 212 is
being heated to achieve a temperature range or set or
pre-programmed temperature, such as 108-degrees Fahrenheit. When
Peltier 212 reaches the pre-programmed temperature, then light
source 210 can switch to a steady or constant illumination mode
(non-blinking).
[0053] One or more embodiments for operation of the eye treatment
device 100, hand piece 200, and more specifically Peltier 212 will
now be described in detail. The present invention is not limited to
the following embodiments for a method of use. In addition, the
following method of use and steps can be performed in any order and
may include some steps and omit others, or include steps not
otherwise disclosed. Peltier device 212 can be regulated to operate
within various temperature ranges. In this regard, an embodiment of
the eye treatment device is to apply heat via the hand piece 200 to
the exterior surface of the closed upper or lower eyelid of a user
via hand piece 200 to treat MGD, meibomian glands, dry eyes and/or
stimulate tears, gland muscles, expression of fluids, expression of
tear film component, among others, as illustrated in FIGS.
23-24.
[0054] In one embodiment for a method of use of the dry eye
treatment device of the present invention, a user or healthcare
professional can un-lock the treatment device 100 via key 108a
within lock 108 (FIG. 1-2). Once unlocked, the main unit 102 can
automatically turn on or the user can manually turn on the device.
The user can then be presented with a home screen via user
interface display 104, as illustrated in FIG. 19. Here, the device
100 and can begin warming up main unit 102 and heating Peltier 212
of hand piece 200. The home screen display can further display a
timer 1400 for the user to observe until Peltier 212 (and
ultimately parts 300, 302, 304) of hand piece 200 is fully heated.
In the current embodiment, warm up time can be approximately five
minutes; in other embodiments, the warm-up time can be anywhere
from 5 seconds up to and including 15 minutes. Here, once the timer
reaches zero, the user can select start icon 1402 and the display
screen can move to the user interface treatment or session screen
illustrated in FIG. 20. Alternatively, the display can
automatically move to a treatment or session screen in FIG. 20
without additional user input. In addition, light source or light
indicator 106 (FIG. 1) can be in a steady (on) illumination mode
when the unit is warming up and in a blinking (on/off) mode when
the unit has fully heated hand piece 200 and is ready for
operation, vice versa. For example, during a treatment session,
there may be a temperature drop at the eyelid contact applicator
300 where the hand piece may briefly go into warming up mode
(blinking light from 106) and then resume a fully heated mode
(steady illumination from 106), or vice versa. In other
embodiments, light indicator 106 can be in one color (e.g., red)
while the device is warming up and switch to another color (e.g.,
green) when the device is ready to operate.
[0055] Referring to FIG. 20, the user can be provided with the
option to set a timer 1408 for how long he or she wants to operate
the eye treatment device for a given session. Timer 1408 can be
pre-programmed or set by the user by selecting upper icon 1406 for
increasing time and lower icon 1416 for decreasing the time, and a
timer is running indicator 1414. Here, during a treatment session
(or prior to beginning a session), a user may go back and forth
between various screens. For example, help icon 1418 will allow the
user to view and review various help, procedure, safety, tips, and
guidance for operating the user treatment device. A global continue
icon 1410 allows the user to go back to main treatment screen in
FIG. 20 without interrupting operation of the timer 1408 (if a
treatment session has already been initiated). Here, once the user
has set the timer for a particular session, he or she can select
the Start/Stop icon 1412 to start the timer which will direct the
user to user interface display screen in FIG. 21, and the user can
begin treating one or more eyelids of a patient with hand piece 200
(FIG. 23-24), which will be described in detail later. A shutdown
icon 1404 is also provided.
[0056] In one embodiment for a method of use for the eye treatment
device, as shown in FIGS. 23-24, a gel 502 or a suitable chemical,
cream, liquid, or substance for transferring heat can be applied to
the outer exterior surface of upper eyelids of patient 600 prior to
beginning a treatment session. Here, the gel or substance can be an
ultrasound gel. The gel 502 can be applied prior to even turning on
the device 100 or during the warm up session (FIG. 19). More
specifically, the eyelids can be coated with the ultrasound gel
prior to bringing the eyelid contact piece 304 in direct contact
the exterior eyelid of the patient 600. In advantage of applying
the ultrasound gel is that the heat dissipated by component eyelid
contact component 304 can penetrate the eyelid and meibomian glands
much deeper than without it, thereby improving the ability of the
eye treatment device in treating MGD, meibomian glands, dry eyes
and/or stimulate tears, gland muscles, expression of fluids,
expression of tear film component, among others. The ultrasound gel
can comprise of the ingredients propylene glycol, glycerin,
phenoxyethanol, and a colorant. Furthermore, a darker colored
ultrasound gel (such as black) or a clear ultrasound gel can also
be used, wherein the darker colored ultrasound gel can allow the
heat to penetrate through the outer eyelids much deeper than clear
or light-colored ultrasound gels. In other embodiments, no gel or
liquid may be used, and the eyelid applicator can be used and
operated on the outer eyelids without additional substances applied
to the eyelids.
[0057] Once the gel has been applied to the eyelid and the timer
1408 has been set and started, the user 500 can gently place the
outer surface of eyelid contact piece 304 into direct contact with
the closed exterior surface of the user's eyelid, such as the upper
eyelid. Here, depending on the application and patient, the piece
304 of hand piece 200 can either be gently or at least partially
moved across the outer surface of the eyelid, in addition, the user
can apply a gentle pressure, force, or a massaging action while
moving piece 304 around the exterior surface of the outer upper or
lower eyelids. For example, the massaging action can be in small
circular, angular, or up, down, left, and right motions across the
exterior surface of the upper or lower eyelids. In operation, heat
from the component piece 304 is applied to the eyelid to raise the
temperature at the meibomian glands to the desired level. For
example, heat may be applied to raise the temperature at the
exterior of the eyelid to 102-108 degrees Fahrenheit, preferably
108 degrees Fahrenheit, or any temperature comfortable for the user
or prescribed by a healthcare professional. It is contemplated
within the scope of the invention that the Peltier device 212 can
generate up to 120 degrees Fahrenheit with an approximate 12% drop
in temperature as measured at the eyelid contact piece 304 with
respect to the Peltier device 212.
[0058] As previously mentioned, the heat from Peltier device 212
can be regulated, meaning that Peltier device 212 can be controlled
to be within the desired programmed temperatures and programmed
temperatures that are safe for the eyelid and at a sufficient
temperature for melting, loosening, or softening an occlusion or
obstruction in the meibomian gland. Further, the heat may be
maintained in one or more areas of a single eyelid for a certain
period of time and heat may be maintained for an entire treatment
session, such as for 1-20 minutes, sufficient to raise the
temperature at the meibomian glands sufficient to melt, loosen, or
soften the obstructions or occlusions. Alternatively, and as
previously mentioned, the timer 1408 can be pre-programmed by the
user prior to a treatment session to indicate to the user when a
session is complete. For example, the eye treatment device 100 can
automatically turn off the Peltier 212 of hand piece 200 or device
100 altogether after a pre-set time has been reached.
Alternatively, the timer may shut off while the Peltier 212 is
still running until the main unit is manually shut-off. In
addition, at the end of a session, the main unit 102 can generate
an audible or visual indication. For example, the user interface
screen can display 104 an end of session screen as shown in FIG.
22.
[0059] In an additional embodiment of the eye treatment device, the
user may have one or more pre-programmed temperature and time
profiles saved within the memory unit of device 100. For example,
the user may need to use device 100 in multiple sessions depending
on the severity of the MGD, such as over a course of multiple times
during the day and/or multiple times during the course of a week,
month, year, or multiple years. Regulated heat can include
controlling heat according to a temperature profile saved with the
memory unit of device 100. The temperature profile may be a
constant temperature, or include ramp-ups, ramp-downs, peaks and
valleys. Further, the temperature profile may include heat pulses
or be modulated with various characteristics, including the use of
on/off switching or pulse width modulation (PWM) techniques for
example. The use of modulated heat may allow the temperature to be
raised even higher at the eyelid without damages to the patient's
eyelid since the increased temperatures are applied for shorter
periods of time. Obstructions or occlusions in the meibomian glands
may have melting, loosening, or softening points that are beyond
temperatures that may be applied without the use of modulated heat.
The temperature needed to melt, loosen, or soften obstructions or
occlusions may depend on how keratinized the obstruction or
occlusion is. Not all obstructions or occlusions have the same
melting, loosening, or softening points. In other embodiments, a
user, patient, or healthcare professional can also manually
regulate the temperature in real-time on device 100 via user
interface display 104, wherein display 104 shows the temperature of
the Peltier device 260 within hand piece 200. In other embodiments,
device 100 can be wired or communicate wirelessly with a server,
compute device, or mobile device. In other embodiments, the eye
treatment device of the present invention is not intended to direct
electrical signals to the eyelids. In addition, the eye treatment
device of the present invention is not intrusive and does not lift
the eyelids nor does it involve the eyelid applicator (or any other
component) being positioned underneath the eyelids or treat the
eyelids from underneath the eyelids.
[0060] Having thus described the several embodiments of the present
invention, those of skill in the art will readily appreciate that
other embodiments may be made and used which fall within the scope
of the claims attached hereto. Numerous advantages of the invention
covered by this document have been set forth in the foregoing
description. It will be understood that this disclosure is, in many
respects, only illustrative. Changes can be made with respect to
various elements described herein without exceeding the scope of
the invention. Although the present invention has been described in
considerable detail with reference to certain preferred versions or
embodiments thereof, other versions and embodiments are possible.
For example, the present invention can also only comprise of a
portable hand piece that is wireless and operates on battery and
includes components such as a controller, display, and Peltier
device without the need for main unit 102. For example, one or more
components of main unit 102 can be integrated with a stand-alone
and portable hand piece, similar to hand piece 200, for treating
eye conditions. Therefore, the spirit and scope of the appended
claims should not be limited to the description of the preferred
versions contained herein.
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