U.S. patent application number 17/679450 was filed with the patent office on 2022-09-08 for apparatus and method for treatment of dry eyes.
The applicant listed for this patent is LUMENIS BE LTD.. Invention is credited to Hernan Altman.
Application Number | 20220280799 17/679450 |
Document ID | / |
Family ID | 1000006362425 |
Filed Date | 2022-09-08 |
United States Patent
Application |
20220280799 |
Kind Code |
A1 |
Altman; Hernan |
September 8, 2022 |
APPARATUS AND METHOD FOR TREATMENT OF DRY EYES
Abstract
A disposable/removable tip attachable on a distal end of a fiber
bundle, allowing transmitting light energy from the fiber bundle to
an eyelid and comprising a contact surface made of bio-compatible
material, which allows to contact the eyelid and in addition an
add-on device, comprising a fiber bundle, having a distal and
proximal end, wherein a disposable/removable tip is attachable to
the distal end, while the proximal end is connected to an optical
coupler, designed for optical and/or energy coupling with a
lightguide of a Meibomian gland expression (MGX) treatment
device.
Inventors: |
Altman; Hernan; (Kyriat
Tivon, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LUMENIS BE LTD. |
YOKNEAM |
|
IL |
|
|
Family ID: |
1000006362425 |
Appl. No.: |
17/679450 |
Filed: |
February 24, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16367774 |
Mar 28, 2019 |
11285334 |
|
|
17679450 |
|
|
|
|
62666162 |
May 3, 2018 |
|
|
|
62718134 |
Aug 13, 2018 |
|
|
|
62649786 |
Mar 29, 2018 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2005/0644 20130101;
A61N 2005/0651 20130101; A61N 1/40 20130101; A61N 5/0613
20130101 |
International
Class: |
A61N 1/40 20060101
A61N001/40; A61N 5/06 20060101 A61N005/06 |
Claims
1-10. (canceled)
11. A system for treating ocular tissue of a patient comprising: an
energy source to provide energy to treat the ocular tissue; an
elongated member having a distal end and a proximal end, the
proximal end comprising a coupler, the coupler being configured to
be coupled to the energy source, the distal end of the elongated
member being configured to contact the ocular tissue, and wherein
the elongated member is configured to transmit energy from the
energy source to the proximal end and through the elongated member
to the distal end of the elongated member.
12. The system of claim 11 wherein the energy source is selected
from one or more of: laser, LED, radio frequency and
ultrasound.
13. The system of claim 11, wherein the elongated member comprises
an optical fiber.
14. The system of claim 13, wherein the energy source is an intense
pulsed light source (IPL) source in a handpiece having an opening
that is configured to receive the coupler on the proximal end of
the optical fiber.
15. The system of claim 14, wherein the coupler on the proximal end
of the optical fiber comprises an optical coupler interface.
16. The system of claim 11, wherein the delivered energy is in the
form of an intense pulsed light (IPL) source.
17. The system of claim 14, wherein one of the coupler on the
proximal end of the optical fiber or the energy source further
comprises one or more of a wavelength filter and/or an energy
damper configured to selectively deliver energy to the ocular
tissue at a selected wavelength and/or to attenuate the energy
level delivered.
18. The system of claim 12, wherein the system is configured for
performing Meibomian gland expression (MGX) on a patient's ocular
tissue.
19. The system of claim 13, wherein the distal end of the optical
fiber further comprises a soft tip that is configured to contact
the ocular tissue.
20. The system of claim 13, wherein the distal end of the optical
fiber further comprises a pen-like shaped adapter configured to be
held by an operator performing MGX.
21. The system of claim 20, further comprising an operating button
configured to activate the source of energy.
22. The system of claim 14, wherein the distal end of the optical
fiber further comprises a handle configured to be grasped by an
operator performing MGX.
23. The system of claim 14, further comprising an L-shaped tip
mounted on the distal end of the optical fiber, the L-shaped tip
being configured to be inserted behind an eyelid of a patient to
protect the eye while an eyelid is being treated with the IPL
energy source.
24. The system of claim 14, wherein the optical fiber is comprised
of a bundle of fibers having a diameter of 5 mm.
25. The system of claim 14, wherein optical fiber is a doped fiber
that acts as a low-pass filter.
26. The system of claim 23, further comprising a shield configured
to be placed on a patient's eye to protect the eye during treatment
by the IPL energy source.
27. The system of claim 26, wherein the shield is one of: tinted or
opaque to wavelengths of energy generated by the IPL energy
source.
28. The system of claim 27, wherein the shield is in the form of
one of: corneal, semi-scleral or scleral.
Description
RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
application Ser. No. 16/367,774, filed Mar. 28, 2019, which is
related to and claims priority to U.S. provisional application Ser.
No. 62/649,786, filed Mar. 29, 2018, as well as U.S. provisional
application Ser. No. 62/666,162, filed May 3, 2018, and 62/718,134,
filed Aug. 13, 2018, the entire contents of all of which are herein
incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to an apparatus and method of
treating dry eyes using a disposable/removable tip and an energy
source that treats as well as heats a Meibomian Gland, the energy
source being selected from among light sources, radio frequency
(RF) sources and/or ultrasound (US) or other sources.
BACKGROUND OF THE PRESENT INVENTION
[0003] One main reason for dry eyes is blepharitis, a chronic
inflammation of the eyelid margin. This is because if eyelid glands
are chronically inflamed, they produce too little or even no
secretions, which leads to an unstable tear film The treatment of
chronic blepharitis is not trivial, as it is often caused by
pathogens such as bacteria and skin mites.
[0004] It has been shown that, for example, treatment with IPL
(Intense Pulsed Light) light therapy or other has a long-lasting
effect and bacteria and skin mites are successfully eliminated. IPL
is a light pulse therapy that may be used to treat the inflammatory
causes of dry eye, stimulate the eyelid glands and accelerate
healing. Other light sources, such as LED or laser light, may be
used. The use of a light source is for the purpose of generating
heat, and causing photomodulation, so as to heat up the area of a
Meibomian Gland, so other sources of generating heat may be
used.
[0005] U.S. Pat. Nos. 9,333,370 and 10,085,814, assigned to the
assignee of the present invention, are directed to dry eye
treatments and are herein incorporated by reference in their
entireties.
[0006] In the course of treatment, several pulses of light may be
delivered to a patient's eyelids. Care should be taken to avoid
direct light entry into a cornea, as well as exposure of eyelashes
to the energy (to avoid hair loss). In addition, direct heating of
a cornea and other ocular surfaces should be avoided.
[0007] In the treatment of MGD (Meibomian Gland Dysfunction, or
evaporative Dry Eye), Meibomian gland expression (MGX) is also a
therapeutic approach, in which the glands are squeezed, generally
after being heated through the use of IPL energy, LED energy or
other energy, to force the meibum secretion out. Typically, this is
achieved by pressing the eyelid from the outside with a finger,
against a q-tip placed between the eyelid and the sclera.
Sometimes, dedicated pincers or paddles are used for MGX.
SUMMARY OF THE PRESENT INVENTION
[0008] In an aspect, a method of treating ocular tissue by
application of energy for treating dry eye includes: providing an
energy generating device, the device further comprising a tip, and
the tip has an extension that can be inserted posterior to an
eyelid; the energy-generating device provides energy to the
posterior of the eyelid; the method includes the steps of:
inserting the tip posteriorly of the eyelid prior to applying
energy to the posterior surface of the eyelid; and, applying energy
from the energy device to the posterior surface of the eyelid.
[0009] In another aspect, a shielding extension is provided on the
extension and includes a thermally insulative material such that
energy not absorbed by a target tissue is prevented from reaching
ocular tissue located posterior to the eyelid.
[0010] In a further aspect, the shielding extension is configured
to be inserted posterior to an eyelid between the ocular
conjunctiva and palpebral conjunctiva. The tip may be a removable
tip. Further, the energy generating device is a light energy
generating device. The light energy device may be one or more of:
LED energy or IPL.
[0011] In yet a further aspect, the energy device may be one or
more of: RF energy or ultrasonic energy.
[0012] In an aspect, a method of treating ocular tissue during
application of energy for treating dry eye may include: providing
an energy generating device, the device further comprising a tip
which may be generally U-shaped and configured to be inserted both
anterior and posterior to an eyelid; the energy-generating device
provides energy to one or both of the anterior and the posterior of
the eyelid; the method comprising the steps of: inserting the tip
anteriorly and posteriorly of the eyelid prior to applying energy
to one or more of the anterior and posterior surfaces of the
eyelid; and, applying energy from the energy device to one or more
of the anterior and posterior surfaces of the eyelid.
[0013] In another aspect, a shielding extension is provided on the
posterior portion of the tip and is comprised of a thermally
insulative material such that energy not absorbed by a target
tissue is prevented from reaching ocular tissue located posterior
to the eyelid.
[0014] In a further aspect, the energy generating device further
comprises a shaft having a distal end portion; the shaft may be
movable toward and away from the anterior of the eyelid; and, the
energy generating device may be mounted on the distal end portion
of the shaft; the method includes the steps of: moving the shaft
distally to contact the anterior of the eyelid; activating the
energy-generating device to provide energy to the posterior of the
eyelid; and, moving the shaft further distally to apply pressure to
the eyelid positioned between the distal portion of the shaft and
the tip extension posterior of the eyelid.
[0015] An objective of embodiments herein is to eliminate or at
least alleviate the problems discussed above.
[0016] An embodiment relates to a disposable/removable tip (DT)
attachable on the (distal) end of a fiber bundle, allowing
transmitting light energy from the fiber bundle to an eyelid and
comprising a contact surface made of bio-compatible material, which
allows to contact the eyelid. Preferably the disposable/removable
tip allows transmitting light energy from the fiber bundle to the
posterior surface of the eyelid.
[0017] For this purpose, the DT preferably comprises a bent or
inflected structure of a transparent or translucent material.
Preferably the DT has a spatula distal tip bent down with respect
to the optical fiber bundle.
[0018] Even more preferably the DT comprises means (e.g. opaque or
reflecting portions of the DT) for protecting the eyelashes, hair
follicle or an eye against damage caused by light or high
temperature.
[0019] According to another preferred embodiment of the invention,
the DT comprises a distal tip and a proximal tip which form a clamp
preferably bent downwards with respect to the fiber bundle and
adapted to encompass or grasp an eyelid therebetween.
[0020] A disposable/removable tip has a lot of advantages compared
to a tip fixed to a medical device or light guide. But however it
should be clear that the treatment can also be administered with a
fixed tip having the same features as described above.
[0021] Another embodiment relates to an add-on device, comprising a
fiber bundle, having a distal end and a proximal end, wherein a
disposable/removable tip is attachable to the distal end, while the
proximal end is connected to an optical coupler, designed for
optical and/or energy coupling with light source, like a Lumenis
M22 handpiece or other IPL devices.
[0022] Another embodiment relates to a system of the
disposable/removable tip and the add-on device.
[0023] Another aspect of the invention is a method for treating
blepharitis or Meibomian gland dysfunction comprising the steps of
treating a patient's eyelids with IPL/Light using a disposable tip
as described above and preferably also executing Meibomian gland
expression (MGX).
[0024] Yet another aspect of the invention is the use of a
protective contact lens that is inserted prior to treatment that
protects a cornea and other ocular surfaces from the light and/or
heat sources used in the course of treatment for dry eyes by
providing thermal isolation through use of the protective contact
lens as described herein.
[0025] Yet another aspect of the invention is to connect the tip to
a vacuum source causing the tip to "stick" to the eyelid. For this
purpose the tips described above and below in the drawings may
comprise (a) through hole(s) in the soft material of the tips that
is/are connected to a vacuum source on a proximal end having (a)
distal suction ending(s) in the vicinity of a patient' s posterior
or anterior eyelid. The vacuum source can be included in the add-on
device or the IPL/light source.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Some embodiments of apparatuses and/or methods will be
described in the following by way of example only, and with
reference to the accompanying figures, in which
[0027] FIG. 1 shows a disposable tip with a round, soft shape;
[0028] FIG. 2a shows a disposable tip with a concave shape;
[0029] FIG. 2b shows an alternative disposable tip with a concave
shape;
[0030] FIG. 3a shows a disposable tip with an eyelid clamp;
[0031] FIG. 3b shows a disposable tip with light guidance;
[0032] FIG. 3c shows a disposable tip with an eyelid clamp moved
with a telescope;
[0033] FIG. 3d shows a disposable tip with an eyelid clamp moved
with a sledge;
[0034] FIG. 4 shows a system for forwarding light energy.
[0035] FIG. 5 shows an insert for the protection of the patient's
eye.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0036] Various exemplary embodiments will now be described more
fully with reference to the accompanying drawings in which some
example embodiments are illustrated.
[0037] Anatomical terms of location, like distal and proximal refer
to the devices described not to a patient (except where mentioned
otherwise). In consequence, a distal end of a device may be closer
to a patient, than a proximal end of the device.
[0038] In general, referring now to FIG. 1, a disposable or
removable tip (DT) 1 may be constructed of a transparent or
translucent material, such as silicone, which allows delivery of
light energy (preferably IPL or laser) to an eyelid 5.
[0039] The DT 1 may be provided in clean/sterile state i.e.
packaging, for example one for each eye, to allow hygienic
treatment for every patient.
[0040] During the procedure, the DT packaging is opened and the DT
1 is mounted over the distal end 4 of the fiber bundle 2. Mounting
may be accomplished by adhesive, force-fitted (friction between
sides of the fiber bundle 2 and an annular part of the DT
surrounding the fiber bundle 2) or form-fitted (e.g. by a
thread).
[0041] The fiber bundle 2, in particular an optical fiber cable,
also known as a fiber optic cable, is an assembly similar to an
electrical cable, but containing one or more optical fibers that
are used to carry light, which light source may be Intense Pulse
Light (IPL)or another light source, such as LEDs. The fiber bundle
2 may be surrounded by a protective tube 12, which may have a
reflective inner surface.
[0042] In several of the following embodiments, a semi-transparent
material can be used to manufacture the DT 1, for example, by
doping or tinting the material. One such material is silicone. By
using such a technique, a part of the light energy will be absorbed
by the DT 1, thus heating it and resulting in delivery of this heat
to a surrounding patient's tissue, for example an eyelid. For some
applications, heat has been shown to be a useful treatment modality
for MGD, alleviating some Dry Eye symptoms. According to another
aspect of the invention the DT (not shown), the DT may include a
temperature sensor for sensing the temperature of the tip itself
and/or a patient's eyelid while in use.
[0043] If heating is not desired or is achieved by other means, a
transparent material may be used to forward as much of the light
energy as possible.
[0044] The treatment process might comprise a first step, wherein
an eyelid 5 is heated up with a heating element or a light source
as described above. In a second step--after the eyelid has been
heated a predetermined time or the temperature of the eyelid has
exceeded a predetermined threshold--the outside of the eyelid is
touched and pressure is put on the eyelid 5, which is now clamped
between the tip and a piece or stop, like a Q-Tip, that is
positioned in back of the eyelid 5. According to one alternative,
the heating can be maintained during the second step. According to
further alternatives, the steps of heating and exerting pressure on
an eyelid can be conducted simultaneously or intermittently.
[0045] The materials used may be bio-compatible, for example
silicone, to allow light forwarding from the fiber bundle 2 and
delivery to a patient's skin/tissue, for example, safe contact with
an eyelid 5 or even an eye. This applies at least for light
transmitting parts of the DT 1 or parts coming into contact with a
patient, like the surface of a contact zone facing the patient.
Other parts of the DT1 might comprise different types of
materials.
[0046] FIG. 1 depicts a design which provides a more comfortable
treatment experience for a patient. The light beam 3 may be
transmitted via the fiber bundle 2 and to the distal end 4 of the
fiber bundle 2 and then into the disposable tip (DT) 1. This DT 1
transmits heat from the light beam 3 via a contact surface to the
patient's eyelid. A round, soft tip 11 allows a comfortable
interface for the physical contact between the tip 11 and the
eyelid 5. The soft tip 11 may also be hemispherically shaped (shown
in FIG. 2a, 3a) so that, when contacting the eyelid, the softness
of the material distributes the force and in consequence the
pressure on the eyelid 5.
[0047] FIG. 2a depicts a concave-shaped DT 1 which enables better
conformation to the natural curvature of the eyelid 5, as a mere
surface contact would do. This allows stable delivery of light and
heat from a light source, as well as the capability to generate a
vacuum between the DT 1 and the eyelid 5, effectively attaching the
DT 1 to the eyelid 5 (similar to the principle of a vacuum
cup).
[0048] FIG. 2b depicts an enhanced version of the DT 1 of FIG. 2a
to allow usage of the DT 1 for MGX. The fiber bundle 2 is
positioned within a lumen 22 of a tube 21 or shaft. The tube 21
surrounds the fiber bundle 2. The tube has one end aligned with the
distal end 4 of the fiber bundle 2 while the other end of the tube
21 has an open end with the fiber bundle 2 proceeding further
proximal. A handle (not depicted) for manually moving the tube 21
axially/translational may be attached proximal to the distal
tip.
[0049] The DT 1 is attached to the external tube 21, thus covering
also the centered fiber bundle 2. Therefore, the DT 1 may overlap
the tube 21 in a proximal direction, like a cap. The attachment
(e.g. force-fitted) between the DT 1 and tube 21 is of such a
strength, which allows movement within the DT 1, in particular
shearing forces, induced by moving the fiber bundle 2 inside the
lumen 22 in a distal direction relatively to the tube 21.
[0050] To treat MGX, the tube 21 or DT 1 is gently pulled away from
the eyelid 5 or/and at the same time pushing the fiber bundle 2
towards the eyelid 5. This causes a change of the radius of the
concave shaped contact surface, as the fiber bundle 2 presses
towards the center of the concave contact surface, while the outer
part of the concave contact surface is pulled away by the tube 21,
which is connected at the outer part of the DT 1.
[0051] This causes pulling the eyelid's 5 external surface (where
the outer region 23 of the DT 1 is located), by an outward force
24, due to the vacuum between the DT 1 and eyelid 5, while pushing
a center region 25 of the eyelids, aligned with the fiber bundle 2,
by an inward force 26.
[0052] The effect is that a first region (center region 25) of the
eyelid 5 is moved in one direction while a second region (outer
region 23), which is very close to the first region, is moved to
the opposite direction. This causes a shearing force on the eyelid
5 which leads to a squeezing effect, effectuating MGX.
[0053] Advantageously, a DT 1 is provided which is easy to assemble
and in addition to IPL treatment allows MGX treatment.
[0054] FIG. 3a depicts another embodiment of a DT 1 in a cross
section of the eyelid 5 with the DT 1 shown placed on both sides of
the eyelid 5. In this embodiment, the DT 1 includes both an inner
(proximal) 32 and an outer (distal) tip 31 of a clamp. A gap 34
separates tips 31 and 32 and may have a variable distance so that
the distance between the tips may be changed. For treatment, the
outer tip 31 (distal) of the DT 1 is located between the eyelid 5
and the sclera 33. The eyelid 5 is placed between both tips 31, 32
and the distance between the tips 31, 32 is reduced to create a
squeezing force suitable for effecting MGX. The reduction in
distance between the tips may be accomplished with a sliding or
other mechanism (to be discussed below in connection with FIGS. 3C
and 3D). The sliding or other action that varies the distance
between tips 31 and 32 may be manual or may be automated using a
motor or other mechanism under manual control or under control of a
suitable controller. A pressure-sensing device may be incorporated
so that the degree of force exerted on the eyelid clamped between
tips 31 and 32 is controllable.
[0055] Advantageously, this embodiment allows a more typical
delivery method of MGX, in particular, using a squeezing force (two
opposite forces aligned) instead of a shearing force (two opposite
forces parallel misaligned). Both embodiments allow, in addition,
light/heat treatment. The combination of providing MGX and
light/heat therapy has proven to be very efficient.
[0056] FIG. 3b depicts a similar embodiment or even an enhancement
of the previous embodiment of FIG. 3a with the goal of a more
efficient energy delivery to the target organs (the Meibomian
glands 35) as well as to protect eyelashes 36. In the DT 1 with the
distal tip 31 and the proximal tip 32 forming a clamp as described
before, the proximal tip 32 may be opaque or comprise an opaque
plastic 37 preferably at least covering part of the surface
which--in the case of use--touches the eyelid in the region of the
eyelashes. This prevents the eyelashes from being damaged.
[0057] The outer surface (not facing the patient's eyelid) of the
DT 1 and especially of the distal end of the DT 1 may be coated
with a highly reflective layer 38. The reflective layer 38 prevents
light from traveling beyond the distal end of the tip, by
reflecting the light/heat back into the tip which may amplify the
amount of light/heat reaching the posterior surface of the
eyelid.
[0058] Advantageously, the light/heat energy can be delivered to
the posterior surface of the eyelid 5 in the vicinity of the
Meibomian glands 35. An additional advantage of this design, due to
the reflective layer 38 is the avoidance of light flashes to the
patient's eye, thus increasing patient's comfort and safety. A
further device for the protection of the patient's eye, such as the
cornea, will be described below in connection with FIG. 5.
[0059] The treatment process might comprise a previous/first step,
where the eyelid 5 is heated up with a heating element (not
displayed) or by the light device itself, as explained previously.
The heated portion is, according to the construction of this
embodiment, at the proximal part of the distal tip 31, which faces
the Meibomian gland 35. Heating exactly this spot is a result of
the reflection of energy by the reflective layer 38. By clamping
the eyelid in the embodiments shown in FIGS. 3a and 3bt, no
additional tool, like a q-tip, is necessary.
[0060] The typical human eyelid thickness is 3-4 mm, with the
eyelashes 36 located on the outside (related to the human head) and
the Meibomian glands 35 located on the inside, occupying 400-600
.mu.m of the eyelid 5 sagittal cross-section. According to this,
the distance between the two tips 31, 32 has to be adapted.
[0061] FIG. 3c depicts another enhancement of the previous
embodiments, more clearly displaying the movement possibilities to
perform MGX. A telescoping element 40 connects the distal tip 31
and the proximal tip 32 of the DT 1, which can telescope in
directions 41 so that the proximal tip 32 is movable towards or
away from the eye. A cylindrical tube 39 is mounted on the distal
side of the proximal tip 32 or fiber bundle 2. During treatment,
the cylindrical tube 39 is brought into contact with the eyelid 5
either by sliding the telescoping element 40 in a direction to
decrease the distance between the two tips 31, 32 and, thus,
clamping the eyelid 5 and performing MGX. Alternatively, the
telescoping element 40 may be fixed and the cylindrical tube 39
moved in directions 43 as shown in FIG. 3c to move the tube 39 into
contact with the eyelid 5, such that the eyelid is clamped between
the distal tip 31 and the tube 39.
[0062] FIG. 3d depicts a similar arrangement, wherein, instead of a
telescoping element 40, a proximal tip 32 mounted on the distal end
of a fiber bundle 2 may be moved in directions 42 towards and away
from the eyelid 5. This can be accomplished by a sliding element or
elements as described in connection with FIG. 3c, wherein a part
connected with the distal tip 31 slides onto a part connected with
the proximal tip 32 in a direction towards or away from the eyelid
5. An end element 29, which may be similar to tip 1 of FIGS. 1, 2a
and 2b, may be mounted on the distal end of the proximal tip 32. It
is to be understood that, while in FIG. 3d a fiber bundle 2 is
shown, that the source of light/heat may be mounted on the proximal
end 32 itself so that no fiber bundle may be required.
[0063] Additionally, FIG. 3d shows a heating/light element 27 which
may be mounted on or within distal tip 31. The heating/light
element 27 may be used to heat the eyelid 5 and the contained
Meibomian gland 35 either in conjunction with the heat/light from
the source of light/heat from the fiber 2 or otherwise so that the
gland is heated from both sides of the eyelid 5.
[0064] The arrangement of capturing the eyelid between the tips 31
and 32 may lead to less force being put by the distal tip 31 on a
patient's eye as in the embodiment, for example, of FIG. 1, and
this in turn may lead to less discomfort to the patient.
[0065] FIG. 4 depicts a system in which the treatment end of an
available MGD treatment device 51, like the Lumenis M22 IPL, may be
more easily handled and manipulated close to the treatment area.
This embodiment comprises an add-on device that is attachable to
the handpiece 52 via optical lightguide or lightguide interface 53.
It allows light energy delivery through the fiber and out from the
distal end 4 of the fiber 2 around an eye's orbit (upper and lower
eyelids 5).
[0066] The proximal end of the fiber bundle 2 is attached to an
optical coupler or interface 54, which allows each individual fiber
to spread out, for better coverage of the lightguide 53 surface
area, to allow better optical and energy coupling. This part may be
multi-use due to the need for accuracy and the high
quality/expensive materials required.
[0067] The distal end 4 of the fiber bundle 2 may include an
interface (such as handle adapter 55), for example made of plastic.
An ergonomic handle 56 may be attached thereto, allowing
comfortable positioning of the distal end 4 of the fiber bundle 2
to small areas around the eyes, without the burden of having to
manually hold and manipulate the handpiece 52 of the MGD treatment
device 51.
[0068] Otherwise, without the handle 56, the operator may hold the
distal end 4 of the bundle 2 like a pen while treating the patient.
In order that the distal end 4 maintains its shape, a stiffening
element, which may be a harness or a relatively stiff tube, in
which the distal end 4 is threaded, may be used so that the distal
end 4 can be directly applied over an eyelid 5 to be treated,
without fear of the distal end 4 bending and emitting light energy
to undesired areas around an eye.
[0069] The fiber bundle 2 employed may also incorporate a filter to
allow for wavelength selection as well as act as an energy damper
to reduce the original fluence emitted by the MDG treatment device
51 to acceptable levels for eyelid 5 treatment. The add-on device
allows an adjustability or variability in fluences different to the
one(s) provided by the MDG treatment device 51, thus providing the
possibility for more effective treatments.
[0070] Depending on the use case, the add-on device or fiber bundle
2 may be disposable or reusable. The fiber bundle 2 may be
distributed in a sterile package.
[0071] Parts of the add-on device like the bundle interfaces 54, 55
or the DT switch may degrade after sterilization or cleaning so
that this add-on device would become unusable. This feature would
prevent accidental double use of this single use item.
[0072] The fiber bundle 2 may contain 20-50 fibers with a plastic
casing, to achieve a treatment area (bundle end 4) of --5 mm
diameter.
[0073] The distal end 4 of the fiber bundle 2 itself may optionally
be covered by a DT 1, e.g. by a soft, biocompatible material, like
silicon, as described in various previous embodiments. By covering
the relatively hard distal end 4 with the DT 1 (soft cap), the DT 1
may even contact a patient's eyelid 5, without causing discomfort
to the patient or harm the tissue.
[0074] The handle 56 may include an operating button 58 to trigger
an IPL pulse and or a switch for controlling the clamp mechanism.
In such a case, the handle needs to include an interface, e.g. an
electrical connection to the MDG treatment device. Alternatively,
the IPL pulse generation may be controlled from the handpiece 52 or
from a footswitch operatively connected to the add-on device.
[0075] In addition, as may be seen on 3a-d, an L-shaped distal tip
31, as previously described, may be removable mounted on the distal
end 4 of the fiber bundle 2 or on the distal end of the ergonomic
handle 56. The distal tip 31 may function as a shield that is
inserted behind the eyelids to protect the eye while the upper
and/or lower eyelids 5 are treated.
[0076] The proposed invention/embodiments would allow for:
[0077] 1. Better access to structures around the eye, including the
upper or lower eyelid 5, while avoiding unintended exposure of the
eyelashes 36 or the cornea, which may result from use of a large
lightguide 53 such as the current M22 IPL handpiece 52.
[0078] 2. Ease of use, through the dedicated, lightweight ergonomic
handle 56. This is enabled by the fact that the current IPL
handpiece 52 fulfills the energy and cooling functions, while the
proposed handle's 56 sole function would be to hold the fibers'
distal end 4 and bring it into direct contact above or below the
eyelids 5 (i.e. it only fulfills the ergonomic/usability
functions).
[0079] 3. A sterile, disposable design.
[0080] 4. A modular solution, which allows for the use of the
current handpiece 52 for treatment of Rosacea and supports the
current MGD protocol delivered from tragus to tragus. Most MGD
patients also suffer from Rosacea, making it necessary to treat
them for this indication to alleviate the MGD symptoms.
[0081] 5. Fluence reduction for improved safety around the eyelid 5
area through the design of the fiber bundle 2 as an energy damper
(current M22 IPL has a lower limit on delivered fluence, which may
be considered by some as too high for MGD in certain cases).
[0082] 6. More specific selection of light spectrum, for improved
treatment efficacy, by the use of a doped fiber as a low-pass
filter, in addition to the built-in high-pass filter in the IPL's
handpiece 52.
[0083] Turning now to FIG. 5, that figure shows an additional
element 59 that may be interposed between the tip 31 and the eye
60. The purpose of the element 59 is to protect the eye against any
stray light/heat from causing damage to the eye 60, either due to
excess light or the heat generated by the light (or other) source.
The element or shield 59 may be in the form of a contact lens, such
as a soft-type contact lens, with no optical changing capabilities,
that the doctor may place on the eye to be treated for dry eye. The
shield 59 may be a tinted with a biocompatible dye or ink and may
be chosen to be completely opaque to the wavelengths of light
generated by a light source selected to heat the eyelid. The lenses
may vary in size and on extent of coverage of the eye, and thus may
be corneal, semi-scleral or scleral, depending on the treatment to
be provided. The element may even be completely opaque and maybe
made of a material that reflects light and/or provides heat
insulating properties so that the eye is not subjected to excess
heating which might cause damage to the eye being treated. The
shield may also be a disposable that maybe discards after each
treatment or of a design that can be sterilized and reused.
REFERENCE NUMBERS
[0084] 1 disposable/removable tip (DT)
[0085] 2 fiber bundle
[0086] 3 IPL (Intense Pulse Light)/light beam
[0087] 4 distal end of fiber bundle
[0088] 5 eyelid
[0089] 11 round/soft tip
[0090] 12 protective tube
[0091] 21 tube
[0092] 22 lumen
[0093] 23 outer region
[0094] 24 outward force
[0095] 25 center region
[0096] 26 inward force
[0097] 27 heating element
[0098] 29 end element
[0099] 31 outer (distal) tip
[0100] 32 inner (proximal) tip
[0101] 33 sclera
[0102] 34 intersecting gap
[0103] 35 Meibomian glands
[0104] 36 eyelashes
[0105] 37 opaque plastic
[0106] 38 reflective layer
[0107] 39 cylindrical tube
[0108] 40 telescope
[0109] 41 expanding/shortening direction
[0110] 42 moving direction
[0111] 43 moving direction
[0112] 51 MGD treatment device
[0113] 52 handpiece
[0114] 53 lightguide
[0115] 54 optic coupler
[0116] 55 handle adapter
[0117] 56 handle
[0118] 57 proximal end
[0119] 58 operating button
[0120] 59 shield
[0121] 60 eye
* * * * *