U.S. patent application number 16/883844 was filed with the patent office on 2020-09-24 for apparatus and method for treatment of dry eye using radio frequency heating.
This patent application is currently assigned to THERMIGEN, LLC. The applicant listed for this patent is THERMIGEN, LLC. Invention is credited to Gregory L. ALMOND, Paul R. HERCHMAN, Jr., Kevin D. O'BRIEN.
Application Number | 20200297533 16/883844 |
Document ID | / |
Family ID | 1000004869959 |
Filed Date | 2020-09-24 |
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United States Patent
Application |
20200297533 |
Kind Code |
A1 |
HERCHMAN, Jr.; Paul R. ; et
al. |
September 24, 2020 |
APPARATUS AND METHOD FOR TREATMENT OF DRY EYE USING RADIO FREQUENCY
HEATING
Abstract
The present disclosure is related to a treatment probe and
method for treating dry eye. The treatment probe may include a thin
stainless steel tip, a spacer to ensure proper contact and protect
the skin of a patient, a sensor to provide temperature feedback to
the power supply providing RF energy to the treatment probe. The
treatment focuses on a patient's temple and periorbital area.
Inventors: |
HERCHMAN, Jr.; Paul R.;
(Grapevine, TX) ; O'BRIEN; Kevin D.; (Coppell,
TX) ; ALMOND; Gregory L.; (Keller, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THERMIGEN, LLC |
Irving |
TX |
US |
|
|
Assignee: |
THERMIGEN, LLC
Irving
TX
|
Family ID: |
1000004869959 |
Appl. No.: |
16/883844 |
Filed: |
May 26, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15482480 |
Apr 7, 2017 |
10695219 |
|
|
16883844 |
|
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|
62495592 |
Apr 8, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 9/0079 20130101;
A61N 1/36014 20130101; A61N 1/36046 20130101 |
International
Class: |
A61F 9/007 20060101
A61F009/007; A61N 1/36 20060101 A61N001/36 |
Claims
1. A method of treatment for dry eye, the method comprising
application of a radiofrequency energy to target tissue surrounding
the eye in an amount sufficient to stimulate but not damage nerve
tissue.
2. A method according to claim 1, wherein the radiofrequency energy
is applied through a probe having at least one electrode surface
that emits radiofrequency energy.
3. A method according to claim 1, wherein the radiofrequency energy
applied to is low frequency.
4. A method according to claim 1, wherein the radiofrequency energy
is emitted at a range of about 400 kHz to about 520 kHz; about 430
kHz to about 490 kHz; about 450 kHz to about 470 kHz; about 455 kHz
to about 465 kHz; or about 460 kHz.
5. A method according to claim 1, wherein the radiofrequency energy
is applied in an amount necessary to stimulate nerves to induce
secretion of one or more Meibomian glands.
6. A method according to claim 1, wherein the radiofrequency energy
is applied for a period of time and at a level necessary to raise
the surface temperature of the target tissue to a temperature
between 35 to 47 degrees Celsius.
7. A method according to claim 6, wherein the radiofrequency energy
is applied for a period of time and at a frequency necessary to
raise the surface temperature of the target tissue to a temperature
between 38 to 45 degrees Celsius.
8. A method according to claim 7, wherein the radiofrequency energy
is applied for a period of time and at a frequency necessary to
raise the surface temperature of the target tissue to a temperature
between 42 to 44 degrees Celsius.
9. A method according to claim 1, wherein the target tissue is
heated at between 1 and 5 mm beneath the surface (i.e., between 2
and 2.5 mm beneath the surface).
10. A method according to claim 9, wherein the method further
comprises applying an electrically conductive gel at the site of
the target tissue on a patient.
11. A method according to claim 1, wherein the radiofrequency
energy is applied to the temple and/or to periorbital tissue
adjacent to the eye and/or eyelid.
12. A method according to claim 11, wherein the radiofrequency
energy is applied to the temple and then is applied to the
periorbital tissue adjacent to the eye and/or eyelid.
13. A method according to claim 1, wherein the radiofrequency
energy is applied for a period of 15 seconds to 20 minutes, a
period of 8 minutes to 15 minutes; a period of 8 minutes to 10
minutes; a period of 10 minutes to 12 minutes; or a period of 12 to
15 minutes.
14. A method according to claim 1, wherein the radiofrequency
energy is not applied to the eyelid.
15. A method according to claim 1, further comprising contacting a
grounding pad to a patient on an area of the skin removed from the
tissue surrounding the eye.
16. A method according to claim 1, wherein the radiofrequency
energy is applied using a probe that comprises: a. an electrically
conductive treatment tip positioned at the distal end of a handle,
b. a cable in contact with the treatment tip and running from the
distal end of the handle to the proximal end of the handle, the
cable extending from the handle to a power supply providing
radio-frequency energy to the tip through the cord, wherein the
cord is removable from the power supply c. a spacer configured to
provide an electrically conductive barrier between the treatment
tip and a patient's skin, wherein the treatment tip is adapted to
accept the spacer.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C. .sctn.
120 of U.S. patent application Ser. No. 15/094,814, filed on Apr.
8, 2016, which is being converted to a U.S. Provisional
Application.
FIELD OF THE DISCLOSURE
[0002] The present disclosure relates to systems and methods for
treatment of evaporative dry eye by radio-frequency heating and
reduction to periorbital skin laxity.
BACKGROUND
[0003] Meibomian Gland Dysfunction (MGD) can be the result of
capped glands, plugged or non-functioning glands or partial or
complete gland atrophy. Studies have demonstrated that up to 86% of
Dry Eye Syndrome conditions (also known as keratoconjunctivitis
sicca and keratitis sicca) are due to evaporative issues connected
with MGD. As a result, more emphasis is being placed on MGD
treatment for Dry Eye. Current treatments include LipiFlow from
Tear Science, MiBo ThermoFlo from Pain Point Medical, hot packs and
lid scrubs (commercial to home treatment), yet all of these
therapies have drawbacks.
[0004] LipiFlow has been proven to work well, but it is expensive
with treatments costing over $1800. The functioning unit of the
LipiFlow (heating/massaging units) is not intended for reuse. The
advantage of LipiFlow is that it massages the lid from the exterior
dermal side while heat is simultaneously applied
transconjunctivally, making it an effective and efficient
treatment. MiBo ThermoFlo applies heat transcutaneously, which is
less efficient in terms of altering the consistency of meibomian
lipids.
[0005] Other methods designed to deliver heat to the lids are
applied superficially, e.g., masks, hot washcloths, and others, and
have proven to be inadequate for a number of reasons, most
specifically due to their inability to bring gland temperature up
to required levels, which is estimated to be 40-43.degree. C.
(104-109.degree. F.).
[0006] ThermiEye.TM. technology is currently used on the market as
a cosmetic skin treatment to tighten skin and reduce wrinkles,
under the trade name ThermiSmooth.TM.. It has been shown to be well
tolerated and safe for cosmetic use, but has not been considered
for treatment of dry eye until now.
[0007] This background information is provided to reveal
information believed by the applicant to be of possible relevance
to the present disclosure. No admission is intended, nor should be
construed, that any of the preceding information constitutes prior
art against the present disclosure.
SUMMARY OF THE DISCLOSURE
[0008] With the above in mind, embodiments of the present
disclosure are related to a treatment probe and method for treating
dry eye using an RF electrode assembly coupled to the treatment
tip, wherein the electrode coupled to the treatment tip is
configured to transfer radiofrequency energy to the skin
surrounding the eye in such a way that nerve tissue is stimulated
and/or strengthened around the eye, reducing MGD. Optionally, a
temperature measuring feature is coupled to the electrode assembly,
wherein the temperature--measuring feature coupled to the electrode
assembly is configured to monitor and regulate electrode and skin
temperature, and a protective element that helps to ensure good
contact between the electrode and the patient's skin as the
electrode is moved across a patient's face.
[0009] The ThermiEye.TM. system delivers radiofrequency energy deep
into the skin causing heat to build up where the skin and fat layer
meet. The heat escalates to about 42.degree.-45.degree. C., improve
Meibomian gland function by stimulating nerve tissue. Additionally,
since evaporative dry eye may also be impacted by poor lid-globe
apposition, the reduction of tissue laxity and improved elasticity
of the tissue surrounding the eye lid may help to further diminish
those signs and symptoms classically associated with dry eye.
[0010] In various embodiments, the disclosed protocol treats
periorbital skin laxity and evaporative dry eye conditions
associated with MGD.
[0011] In one embodiment, the present disclosure is directed to a
method of treatment for dry eye (Method 1), the method comprising
directing a radiofrequency energy to target tissue surrounding the
eye in an amount sufficient to stimulate but not damage nerve
tissue.
[0012] 1.1 Method 1, wherein the radiofrequency energy is applied
through a probe having at least one electrode surface that emits
radiofrequency energy.
[0013] 1.2 Method 1 or 1.1, wherein the radiofrequency energy
applied to is low frequency.
[0014] 1.3 Method 1 or 1.1-1.2, wherein the radiofrequency energy
is emitted at a range of about 400 kHz to about 520 kHz; about 430
kHz to about 490 kHz; about 450 kHz to about 470 kHz; about 455 kHz
to about 465 kHz; or about 460 kHz.
[0015] 1.4 Method 1 or 1.1-1.3, wherein the radiofrequency energy
is applied in an amount necessary to stimulate nerves to induce
secretion of one or more Meibomian glands.
[0016] 1.5 Method 1 or 1.1-1.4, wherein the radiofrequency energy
is applied for a period of time and at a level necessary to raise
the surface temperature of target tissue (i.e., epidermis directly
above treated dermal tissue) to a temperature between 35 to 47
degrees Celsius.
[0017] 1.6 Method 1 or 1.1-1.5, wherein the radiofrequency energy
is applied for a period of time and at a frequency necessary to
raise the surface temperature of target tissue (i.e., epidermis
directly above treated dermal tissue) to a temperature between 38
to 45 degrees Celsius.
[0018] 1.7 Method 1 or 1.1-1.6, wherein the radiofrequency energy
is applied for a period of time and at a frequency necessary to
raise the surface temperature of target tissue (i.e., epidermis
directly above treated dermal tissue) to a temperature between 42
to 44 degrees Celsius.
[0019] 1.8 Method 1 or 1.4-1.7, wherein the target tissue is heated
at between 1 and 5 mm beneath the surface (i.e., between 2 and 2.5
mm beneath the surface).
[0020] 1.9 Method 1 or 1.1-1.8, wherein the method further
comprises applying an electrically conductive gel at the site of
the target tissue on a patient.
[0021] 1.10 Method 1 or 1.1-1.9, wherein the radiofrequency energy
is applied to the temple and/or to periorbital tissue adjacent to
the eye and/or eyelid.
[0022] 1.11 Method 1 or 1.1-1.10, wherein the radiofrequency energy
is applied to the temple and then is applied to the periorbital
tissue adjacent to the eye and/or eyelid.
[0023] 1.12 Method 1 or 1.1-1.11, wherein the radiofrequency energy
is applied for a period of 15 seconds to 20 minutes, a period of 8
minutes to 15 minutes; a period of 8 minutes to 10 minutes; a
period of 10 minutes to 12 minutes; or a period of 12 to 15
minutes.
[0024] 1.13 Method 1 or 1.1-1.12, wherein the radiofrequency energy
is not applied to the eyelid.
[0025] 1.14 Method 1 or 1.1-1.13, further comprising contacting a
grounding pad to a patient on an area of the skin removed from the
tissue surrounding the eye.
[0026] 1.15 Method 1 or 1.1-1.14, wherein the radiofrequency energy
is applied using a probe that comprises:
[0027] a. an electrically conductive treatment tip positioned at
the distal end of a handle,
[0028] b. a cable in contact with the treatment tip and running
from the distal end of the handle to the proximal end of the
handle, the cable extending from the handle to a power supply
providing radio-frequency energy to the tip through the cord,
wherein the cord is removable from the power supply
[0029] c. a spacer configured to provide an electrically conductive
barrier between the treatment tip and a patient's skin, wherein the
treatment tip is adapted to accept the spacer.
[0030] 1.16 Method 1.15, wherein the cable is permanently affixed
within the handle.
[0031] 1.17 Method 1.15-1.16, wherein the treatment tip comprises a
flat distal end configured to contact a patient's skin.
[0032] 1.18 Method 1.15-1.17, wherein the treatment tip comprises
an electrically conductive circumferential sidewall.
[0033] 1.19 Method 1.18, wherein the electrically conductive
circumferential sidewall is continuous with the flat distal end of
the treatment tip.
[0034] 1.20 Method 1.15-1.19, wherein the spacer is shaped to cover
the entire treatment tip.
[0035] 1.21 Method 1.20-1.20, wherein the spacer is shaped to cover
the flat distal end and circumferential sidewall of the treatment
tip.
[0036] 1.22 Method 1.15-1.21, wherein the handle comprises an
electrically insulative material.
[0037] 1.23 Method 1.15-1.22, further comprising a temperature
sensor (i.e., a thermocouple).
[0038] 1.24 Method 1.23, wherein the temperature sensor is
positioned adjacent the treatment tip.
[0039] 1.25 Method 1.23-1.24, wherein the temperature sensor abuts
an inner surface of the treatment tip.
[0040] 1.26 Method 1.23-1.24, wherein the temperature sensor is
positioned at an outer surface of the treatment tip to facilitate
contact with a patient's skin.
[0041] 1.27 Method 1.15-1.26, wherein the treatment tip has a
thickness of about 100 microns.
[0042] 1.28 Method 1.15-1.27, wherein the treatment tip is between
10 mm and 20 mm wide.
[0043] In another embodiment, the present disclosure is directed to
radio-frequency emitter (Emitter 2) comprising:
[0044] a. an electrically conductive treatment tip positioned at
the distal end of a handle,
[0045] b. a cable in contact with the treatment tip and running
from the distal end of the handle to the proximal end of the
handle, the cable extending from the handle to a power supply
providing radio-frequency energy to the tip through the cord,
wherein the cord is removable from the power supply
[0046] c. a spacer configured to provide an electrically conductive
barrier between the treatment tip and a patient's skin, wherein the
treatment tip is adapted to accept the spacer.
[0047] 2.1 Emitter 2, wherein the cable is permanently affixed
within the handle.
[0048] 2.2 Emitter 2 or 2.1, wherein the treatment tip comprises a
flat distal end configured to contact a patient's skin.
[0049] 2.3 Emitter 2 or 2.1-2.2, wherein the treatment tip
comprises an electrically conductive circumferential sidewall.
[0050] 2.4 Emitter 2.3, wherein the electrically conductive
circumferential sidewall is continuous with the flat distal end of
the treatment tip.
[0051] 2.5 Emitter 2 or 2.1-2.4, wherein the spacer is shaped to
cover the entire treatment tip.
[0052] 2.6 Emitter 2 or 2.1-2.5, wherein the spacer is shaped to
cover the flat distal end and circumferential sidewall of the
treatment tip.
[0053] 2.7 Emitter 2 or 2.1-2.6, wherein the handle comprises an
electrically insulative material.
[0054] 2.8 Emitter 2 or 2.1-2.7, further comprising a temperature
sensor (i.e., a thermocouple).
[0055] 2.9 Emitter 2.8, wherein the temperature sensor is
positioned adjacent the treatment tip.
[0056] 2.10 Emitter 2.8-2.9, wherein the temperature sensor abuts
an inner surface of the treatment tip.
[0057] 2.11 Emitter 2.8-2.9, wherein the temperature sensor is
positioned at an outer surface of the treatment tip to facilitate
contact with a patient's skin.
[0058] 2.12 Emitter 2 or 2.1-2.11, wherein the treatment tip has a
thickness of about 100 microns.
[0059] 2.13 Emitter 2 or 2.1-2.12, wherein the treatment tip is
between 10 mm to 20 mm wide.
BRIEF DESCRIPTION OF THE DRAWINGS
[0060] FIG. 1 is an orthogonal view of the user end of an RFE10D
Apparatus.
[0061] FIG. 2 is an orthogonal view of the connection end of an
RFE10D Apparatus.
[0062] FIG. 3 is a section view of the Apparatus tip as shown in
Section A of FIG. 1.
[0063] FIG. 4 is a section view the Apparatus tip as shown in
Section A of FIG. 1 with an optional electrode construction.
[0064] FIG. 5 is a flow chart of the method of treatment.
[0065] FIG. 6 shows one possible pattern of treatment.
[0066] FIG. 7 shows one embodiment of the physical instruments
making up the apparatus of the disclosure.
DETAILED DESCRIPTION
[0067] The present disclosure will now be described more fully
hereinafter with reference to the accompanying drawings, in which
preferred embodiments of the disclosure are shown. This disclosure
may, however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein. Rather,
these embodiments are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of the
disclosure to those skilled in the art. Those of ordinary skill in
the art realize that the following descriptions of the embodiments
of the present disclosure are illustrative and are not intended to
be limiting in any way. Other embodiments of the present disclosure
will readily suggest themselves to such skilled persons having the
benefit of this disclosure. Like numbers refer to like elements
throughout.
[0068] Although the following detailed description contains many
specifics for the purposes of illustration, anyone of ordinary
skill in the art will appreciate that many variations and
alterations to the following details are within the scope of the
disclosure. Accordingly, the following embodiments of the
disclosure are set forth without any loss of generality to, and
without imposing limitations upon, the claimed disclosure.
[0069] In this detailed description of the present disclosure, a
person skilled in the art should note that directional terms, such
as "above," "below," "upper," "lower," and other like terms are
used for the convenience of the reader in reference to the
drawings. Also, a person skilled in the art should notice this
description may contain other terminology to convey position,
orientation, and direction without departing from the principles of
the present disclosure.
[0070] Furthermore, in this detailed description, a person skilled
in the art should note that quantitative qualifying terms such as
"generally," "substantially, "mostly," and other terms are used, in
general, to mean that the referred to object, characteristic, or
quality constitutes a majority of the subject of the reference. The
meaning of any of these terms is dependent upon the context within
which it is used, and the meaning may be expressly modified.
[0071] Referring now to FIGS. 1-3, a device, according to an
embodiment of the present disclosure disclosed is an RFE-10D RF
Electrode Assembly, comprising a Handle 1 with an electrode Tip 3
on it that transfers radio frequency energy into the target tissue
only at the location the Tip contacts the tissue. The device
receives its the radio frequency energy through a Cable 2 affixed
to a Radio Frequency Generator 20 (not shown in FIG. 3). The radio
frequency energy travels thru the tissue and exits the body where a
large Return Pad 30 is affixed to the patient (shown in FIG.
7).
[0072] The treatment probe may be configured to elevate the eye's
transconjunctival tissue temperatures to about 40-45.degree. C. to
promote tissue contracture.
[0073] Tip 3 must contact the tissue, but as shown in FIG. 4A, an
optional Spacer 9 composed of a soft, electrically-conductive
material may be employed to provide good electrode-patient contact.
Use of Spacer 9 helps to ensure the radio frequency energy is
evenly distributed over the intended surface area of treatment.
Though Spacer 9 shown in FIG. 4A has a particular shape, the
electrode could be flat, convex, concave, or other shapes that may
be appropriate and comfortable in practice.
[0074] The optional Sensor 10 may be any type of thermal sensing
device, including but not limited to a thermocouple made part of
Spacer 9, in which case Sensor 10 is affixed to the Spacer 9 or Tip
3 so it contacts the patient's skin, or an optical thermal sensing
system mounted on the Spacer 9 or Tip 3 that does not make contact,
but reads the temperature of the patient's skin. The disclosure is
not limited to any particular approach to measuring the skin of the
patient. The current embodiment of the disclosure employs a very
thin walled cup with the thermometer to its inside wall.
[0075] FIG. 7 shows the Emitter is powered by a Power Source 20
conducive to providing energy to the Emitter through the Connector
8 and Cable 2.
[0076] The disclosed Emitter is used to treat the patient around
the eye and forehead, using the process disclosed in FIGS. 5 and
6.
[0077] In one embodiment, a Control Unit 20 may be configured to
deliver additional RF energy so that the temperature at the Sensor
10 can be kept at a desired temperature by the Control Unit's
monitoring of the Sensor 10 and applying more or less power to the
Emitter.
[0078] One of ordinary skill in the art will recognize that there
are various algorithms for feedback circuits and each may be used
by the Control Unit 20 to accomplish substantially the same result
described in the embodiment above. One of ordinary skill in the art
will also recognize that a plurality of methods exist to provide
energy through heat. In another embodiment of the present
disclosure, the RF energy may be replaced with ultrasound, laser
heating, and other methods of providing energy through heat.
[0079] Referring now to FIG. 4, the Emitter can be constructed to
accept an optional Spacer 9. Spacer 9 can be constructed to use an
adhesive or any number of other methods to be placed on Tip 3. When
installed on Tip 3, a user can easily maintain an optimal distance
between the Emitter and the patient's skin. Spacer 9 can be
washable or disposable, providing easy sanitary practices and
separation between patients by changing Spacers 9 between them.
[0080] In the disclosed procedure, a user treats the patient's face
as indicated in FIGS. 5 and 6. The effect of this treatment is to
stimulate nerve growth surrounding the eye, which reduces MGD
conditions in the patient.
[0081] To accomplish this task most effectively, the nervous tissue
around the eye is stimulated by RF energy that traverses a tissue
bed. As electric current permeates a tissue layer, ions found
within that tissue layer conduct the electric current, increasing
kinetic activity of the ions within. Increased ion kinetics and
oscillations engender resistive tissue thermogenesis. Thermogenesis
may be calculable via the Specific Absorption Rate (hereinafter
referred to as "SAR") equation. SAR assesses local electrical
conductivity and magnitude of local electric current density
generated around an electrode.
[0082] A therapeutic benefit of the heat may be localized
thermogenesis. An electric field strength generated by the RF
energy may be capable of heating tissue in close proximity to the
Emitter. With proper power controls, a generated ideal thermal
endpoint may occur close to the Emitter. As a result, only the
desired specific tissue may be affected.
[0083] In some embodiments, the radiofrequency probe disclosed
herein is used in a method of stimulating or innervating nerve
tissue to treat dry eye (i.e., activate one or more Meibomian
glands in a patient).
[0084] A medical practitioner or qualified user then powers on
power source 20 so as to provide radio frequency energy to
treatment tip 3 of the probe. The treatment probe is configured to
apply radiofrequency energy to the treatment area of a patient's
skin to raise the temperature of the tissue. The radiofrequency
energy is applied in an amount necessary to stimulate nerves to
induce secretion of one or more Meibomian glands. Notably, the
radiofrequency emitted from treatment tip 3 is generally a low
frequency, which is intended to provide an amount of energy to the
treatment area to specifically stimulate or innervate nerve tissue
without damaging surrounding tissue. In various embodiments, the
radiofrequency energy emitted has a frequency range of about 400
kHz to about 520 kHz; about 430 kHz to about 490 kHz; about 450 kHz
to about 470 kHz; about 455 kHz to about 465 kHz; or about 460 kHz.
Application of the radiofrequency energy according to the present
method raises the temperature of the target area on a patient's
skin from 35.degree. C. to 47.degree. C. In some embodiments, the
temperature is raised from 38.degree. C. to a maximum temperature
of 42.degree. C. to 45.degree. C. The application of radiofrequency
energy to the treatment area on a patient results in dermal tissue
heated at a depth of about 1 mm to about 5 mm beneath the outer
layer of the epidermis, preferably between 2 mm and 2.5 mm beneath
said outer layer of the epidermis.
[0085] A medical practitioner may adjust the desired target
temperature as necessary according to the needs of the patient. In
various embodiments, the probe comprises a temperature sensor 10,
which is configured to provide temperature information feedback to
power source 20. As discussed herein, in various embodiments power
source 20 contains programming logic to automatically cease supply
of radiofrequency energy once temperature sensor 10 indicates that
a target temperature has been reached. Thus, in methods of use, a
medical practitioner may set a target temperature in power source
20, such that during use, upon reaching the target temperature,
power source 20 automatically ceases to provide radiofrequency
energy to treatment tip 3.
[0086] Once a target temperature is set, a medical practitioner
brings treatment tip 3 in contact with the temple and/or
periorbital tissue surrounding the eye. The probe is oriented
relative to the target surface such that the entire surface of the
flat distal end of treatment tip 3 is substantially parallel with
the patient's skin. An even pressure is applied while moving the
treatment tip around the target area at the patient's temple and/or
periorbital tissue. This motion is repeated until the target skin
temperature is reached. In various embodiments, treatment tip 3 is
applied to an area of the patient's skin where nerves in
communication with Meibomian glands are located. The radiofrequency
energy is applied at such a level and for a period of time so as to
stimulate or innervate the nerves involved in Meibomian gland
function. While radiofrequency energy may be applied to the
periorbital tissue around the eye, it is not applied to the
eyelid.
[0087] In some embodiments, the treatment area comprises a "C"
shape around a patient's eye. The treatment area is continuous from
the superior nasal areas located slightly below the eyebrow to the
temporal area to the tissue beneath the lower eyelid. In various
embodiments, the radiofrequency energy is applied for a period of
15 seconds to 20 minutes, and may be adjusted according to the
needs of a particular patient. Thus, in some embodiments, the
treatment spans a period of 8 minutes to 15 minutes; a period of 8
minutes to 10 minutes; a period of 10 minutes to 12 minutes; or a
period of 12 to 15 minutes.
[0088] Generally, the methods of treatment as disclosed herein
comprise applying a grounding pad 30 to an area of the patient's
skin close to the area being treated. In various embodiments, the
area being treated is the periorbital tissue surrounding the eye
and/or temple area on a patient's skin. Grounding pad 30 may be
disposable and comprise an adhesive surface to adhere to a selected
area of the patient's skin. An electrically conductive gel (i.e.,
coupling gel) is applied to the treatment area of the patient prior
to treatment tip 3 being brought into contact with the treatment
area. In some embodiments, the gel is an aqueous gel that does not
contain glycerin. Preferably, the gel is colorless.
[0089] In this Emitter, the Tip 3 has been made much thinner, with
embodiments ranging from 10 to 20 mm in width, but only 100 micron
thick. This construction is advantageous because it allows for
quick response time.
[0090] Regulation of tissue temperature may derive from power
control circuitry residing in the Power Source 2 0, which controls
the RF power output (and heating) by increasing or decreasing the
RF voltage that is transmitted through the cable and to the Tip
into the tissue, and monitoring patient tissue temperature.
[0091] Some of the illustrative aspects of the present. Disclosure
may be advantageous in solving the problems herein described and
other problems not discussed which are discoverable by a skilled
artisan. While the above description contains much specificity,
these should not be construed as limitations on the scope of any
embodiment, but as exemplifications of the presented embodiments
thereof. Many other ramifications and variations are possible
within the teachings of the various embodiments. While the
disclosure has been described with reference to exemplary
embodiments, it will be understood by those skilled in the art that
various changes may be made and equivalents may be substituted for
elements thereof without departing from the scope of the
disclosure. In addition, many modifications may be made to adapt a
particular situation or material to the teachings of the disclosure
without departing from the essential scope thereof. Therefore, it
is intended that the disclosure not be limited to the particular
embodiment disclosed as the best or only mode contemplated for
carrying out this disclosure, but that the disclosure will include
all embodiments falling within the scope of the appended claims.
Also, the drawings and the description, there have been disclosed
exemplary embodiments of the disclosure and, although specific
terms may have been employed, they are unless otherwise stated used
in a generic and descriptive sense only and not for purposes of
limitation, the scope of the disclosure therefore not being so
limited. Moreover, the use of the terms first, second, etc. do not
denote any order or importance, but rather the terms first, second,
etc. are used to distinguish one element from another. Furthermore,
the use of the terms a, an, etc. do not denote a limitation of
quantity, but rather denote the presence of at least one of the
referenced item.
[0092] Thus, the scope of the disclosure should be determined by
the appended claims and their legal equivalents, and not by the
examples given.
[0093] A legend of the components discussed in the application and
shown on the drawings is as follows: [0094] 1 Handle [0095] 2 Cable
(Silicon Jacket) [0096] 3 Tip, 10 mm [0097] 5 Bend Relief [0098] 6
Heat Shrink Label Band [0099] 7 Bend Relief [0100] 8 Connector
[0101] 9 Spacer (optional) [0102] 10 Sensor [0103] 20 Power Source
(Radio-Frequency Generator) [0104] 30 Return Pad
EXAMPLES
Example 1
[0105] 18 patients aged 45 to 65 with evaporative dry eye and
periorbital skin laxity were selected to undergo radiofrequency
treatment for dry eye. All selected patients exhibited Meibomian
gland dropout. The enrolled patients were evaluated and baseline
measures for periorbital skin laxity, presence of wrinkles, dry eye
symptoms, ocular surface and extent of Meibomian gland dropout.
After the initial evaluation, patients were treated in a randomized
eye. Contralateral eyes were left untreated.
[0106] Prior to each instance of treatment, patients were given
questionnaires to evaluate their apparent symptoms. During
treatment, a grounding pad was applied to an area on the skin close
to the treatment area (i.e., periorbital tissue). Conduction gel
was applied to the skin such that the treatment area was thoroughly
coated. The RF generator was powered up, and the treatment
temperature was initially set to 38.degree. C. The electrode on the
probe was brought into full contact with the patient's skin, and
using even pressure and sweeping motions, the temperature of the
skin was increased to the target temperature setting (i.e.,
38.degree. C.). Once achieved, the temperature was raised by
increments of one degree until a target temperature of 42.degree.
C. to 45.degree. C. was reached. After treatment, all patients were
cleansed and were tested for tear meniscus height, standard dry eye
test (DET) using sodium fluorescein strips for tear film break-up
time (TFBUT), non-invasive tear break-up time (NITBUT), lipid layer
thickness (LLT), and corneal staining.
[0107] Treatment according to the method carried out on day 0 was
repeated to the randomized eye on days 15 and 30 of the study, and
observations were recorded. The contralateral eye was again left
untreated. On day 45, no treatment was given, but exit observations
were recorded.
[0108] A comparison of measures between Visit 1 and the Exit visit
on Day 45 showed that the vast majority of patients noticed an
improvement in dry eye symptoms over the course of the test period.
9 of the 18 patients showed some incremental improvements with DET
TFBUT and 12 of the 18 patients showed improvement in corneal
staining. 9 patients demonstrated improvements in LLT, and 10
patients improved with NITBUT, which was measured using a
keratograph. These results are especially encouraging since the
treatment was not applied to the eye lid at or near the Meibomian
glands, but rather on the surrounding tissue removed from the
Meibomian glands. There were no noticeable changes to tear meniscus
height or Meibomian glands over the course of the study.
[0109] Interestingly, the untreated contralateral eyes showed
almost equivalent improvements in the same four objective measures
LLT, corneal staining, NIBUT and DET TFBUT. This effect was
especially unexpected, since no radiofrequency treatment was not
applied locally to contralateral tissue.
[0110] The results show significant improvement in dry eye symptoms
using the described treatment.
* * * * *