U.S. patent application number 17/568989 was filed with the patent office on 2022-04-28 for apparatus and method for applying light in ocular and periocular areas.
The applicant listed for this patent is LUMENIS LTD.. Invention is credited to Kfir Azoulay.
Application Number | 20220125546 17/568989 |
Document ID | / |
Family ID | 1000006068503 |
Filed Date | 2022-04-28 |
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United States Patent
Application |
20220125546 |
Kind Code |
A1 |
Azoulay; Kfir |
April 28, 2022 |
APPARATUS AND METHOD FOR APPLYING LIGHT IN OCULAR AND PERIOCULAR
AREAS
Abstract
A removable tip for a light energy handpiece comprises a hollow
conduit configured to surround a light guide in the handpiece; a
support extension having a length longer than a length of the
hollow conduit; and a shielding extension coupled to the support
extension at an angle less than 180 degrees and located in front of
the hollow conduit. The shielding extension is configured to be
inserted behind an eyelid and extend to the fornix, the shielding
extension comprised of a thermally insulative material.
Inventors: |
Azoulay; Kfir; (Amsterdam,
NL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LUMENIS LTD. |
Yokneam |
|
IL |
|
|
Family ID: |
1000006068503 |
Appl. No.: |
17/568989 |
Filed: |
January 5, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17346254 |
Jun 13, 2021 |
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17568989 |
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16595711 |
Oct 8, 2019 |
11065076 |
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17346254 |
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16232968 |
Dec 26, 2018 |
10478264 |
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16595711 |
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16117218 |
Aug 30, 2018 |
10426564 |
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16232968 |
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15069660 |
Mar 14, 2016 |
10085814 |
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16117218 |
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13707834 |
Dec 7, 2012 |
9333370 |
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15069660 |
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61567859 |
Dec 7, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 9/0079 20130101;
A61B 2090/049 20160201; A61N 2005/0644 20130101; A61B 90/04
20160201; A61F 9/008 20130101; A61B 2090/0445 20160201; A61N
2005/0651 20130101; A61N 5/067 20210801; A61N 5/0613 20130101 |
International
Class: |
A61B 90/00 20060101
A61B090/00; A61N 5/06 20060101 A61N005/06; A61F 9/007 20060101
A61F009/007; A61F 9/008 20060101 A61F009/008 |
Claims
1. A method of treating meibomian gland dysfunction by an
application of thermal energy, the method comprising: providing a
handpiece having a thermal energy device at a distal end thereof;
providing a tip on the distal end of the thermal energy device, the
tip having a shielding extension configured to be inserted behind
an eyelid and comprised of a thermally insulative material;
inserting the shielding extension behind the eyelid; contacting the
anterior surface of the eyelid with the tip prior to applying
thermal energy to the anterior surface of the eyelid; applying
thermal energy to the anterior surface of the eyelid; wherein heat
from the thermal energy device treats meibomian gland
dysfunction.
2. The method of claim 1, further comprising the step in which
shielding extension is manipulated to create a mechanical
separation of the target tissue from adjacent posterior eye
structures.
3. The method of claim 1, wherein the shielding extension is
configured to be sufficiently flexible such that it deforms to
conform to irregular eye structure surfaces when inserted.
4. The method of claim 1, wherein the tip comprises a material that
is biocompatible with ocular tissue.
5. The method of claim 1, wherein the handpiece further comprises a
heat sink thermally coupled to the shielding extension.
6. The method of claim 1, wherein the handpiece further comprises a
cooling source thermally coupled to the shielding extension.
7. The method of claim 1, wherein the thermal energy device is a
light energy device.
8. The method of claim 7, wherein the light energy device is
scanned to deliver fractional energy treatment to the eyelid.
9. The method of claim 1, wherein the thermal energy device is
scanned to deliver fractional energy treatment to the eyelid.
10. A device for treating meibomian gland dysfunction by an
application of thermal energy, the method comprising: a handpiece
having a thermal energy device at a distal end thereof; a tip on
the distal end of the thermal energy device, the tip having a
shielding extension configured to be inserted behind an eyelid and
comprised of a thermally insulative material; wherein: the
shielding extension is inserted behind the eyelid, the anterior
surface of the eyelid is contacted with the tip prior to applying
thermal energy to the anterior surface of the eyelid, and thermal
energy is applied to the anterior surface of the eyelid; whereby
heat from the thermal energy device treats meibomian gland
dysfunction.
Description
RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 17/346,254, filed Jun. 13, 2021, which
is a continuation application of U.S. patent application Ser. No.
16/595,711, filed Oct. 8, 2019, now U.S. Pat. No. 11,065,076,
issued on Jul. 20, 2021, which is a continuation application of
U.S. patent application Ser. No. 16/232,968, filed Dec. 26, 2018,
now U.S. Pat. No. 10,478,264, issued on Nov. 19, 2019, which is a
continuation application of U.S. patent application Ser. No.
16/117,218, filed Aug. 30, 2018, now U.S. Pat. No. 10,426,564,
issued on Oct. 1, 2019, which is a divisional application of U.S.
patent application Ser. No. 15/069,660, filed Mar. 14, 2016, now
U.S. Pat. No. 10,085,814, issued on Oct. 2, 2018, which is a
continuation application of U.S. patent application Ser. No.
13/707,834, filed Dec. 7, 2012, now U.S. Pat. No. 9,333,370, issued
on May 10, 2016, which claims priority from U.S. Provisional Patent
Application Ser. No. 61/567,859, filed Dec. 7, 2011, the entire
contents of which are hereby incorporated by reference.
BACKGROUND
[0002] Light energy sources, whether incoherent such as LEDs or
Intense Pulsed Light (IPL), or coherent, such as a carbon dioxide
(CO2) gas laser, Nd:YAG or Er:YAG solid state lasers, fiber or
diode lasers, have been used for various applications such as
surgical, dermatological and/or aesthetic treatments on areas of
skin and various external and internal body organs and tissues.
However, using energy sources for application to skin surface
areas, particularly in the vicinity of the eye, such as the eyelids
and adjacent regions of the face, also referred to as ocular and
periocular/circumocular areas, may raise safety concerns. For
example, heat dissipation from IPL can cause detrimental damage,
either temporary or permanent, to various ocular structures, such
as the cornea which is the organ responsible for approximately 70%
of the human eye refraction power.
SUMMARY
[0003] In one embodiment, a removable tip for an energy light
producing handpiece is provided. The removable tip comprises a
hollow conduit/cavity configured to surround a light guide in the
handpiece; a support extension having a length longer than a length
of the hollow conduit/cavity; and a shielding extension coupled to
the support extension at an angle less than 180 degrees and located
distally to the hollow conduit/cavity. The shielding extension is
configured to be inserted behind an eyelid and extend to the
fornix, the shielding extension comprised of a thermally insulative
material.
DRAWINGS
[0004] Understanding that the drawings depict only exemplary
embodiments and are not therefore to be considered limiting in
scope, the exemplary embodiments will be described with additional
specificity and detail through the use of the accompanying
drawings, in which:
[0005] FIG. 1 is a block diagram of one embodiment of alight
delivery system.
[0006] FIG. 2 is a block diagram of one embodiment of a handpiece
and handpiece tip.
[0007] FIG. 3 is a block diagram of one embodiment of a removable
handpiece tip.
[0008] FIG. 4 is a block diagram of another embodiment of a
removable handpiece tip.
[0009] FIG. 5 is a block diagram of yet a further embodiment of a
removal handpiece tip.
[0010] FIG. 6 is an exemplary diagram depicting one embodiment of a
removable tip placed to protect ocular tissue.
[0011] FIG. 7 is a flow chart depicting one embodiment of a method
of protecting ocular tissue.
[0012] In accordance with common practice, the various described
features are not drawn to scale but are drawn to emphasize specific
features relevant to the exemplary embodiments.
DETAILED DESCRIPTION
[0013] In the following detailed description, reference is made to
the accompanying drawings that form a part hereof, and in which is
shown by way of illustration specific illustrative embodiments.
However, it is to be understood that other embodiments may be
utilized and that logical, mechanical, and electrical changes may
be made. Furthermore, the method presented in the drawing figures
and the specification is not to be construed as limiting the order
in which the individual steps may be performed. The following
detailed description is, therefore, not to be taken in a limiting
sense.
[0014] The embodiments described below enable safe irradiation of
regions of skin covering or surrounding the eye, using various
therapeutic energy light sources, such as those mentioned above. In
particular, the embodiments described below provide a shield
between ocular structures to be protected and the target tissue as
described below. Thus, the embodiments described below provide
increased protection of sensitive ocular organs as compared to
other systems which rely on external protection, such as the system
described in U.S. Pat. No. 7,886,748.
[0015] FIG. 1 is a high-level diagram of one embodiment of a system
100 for delivering light energy to ocular and periocular areas.
System 100 includes a control console 110 and a handpiece 102
coupled to the control console via an umbilical sheath 108. The
control console 110 is configured to generate energy at levels
appropriate for palpebral treatments. Hence, the control console
110 includes, inter alia, power-supplies and control electronics
for components of the handpiece 102. The control electronics 112
and power supplies 114 are connected to the handpiece 102 via the
umbilical sheath 108.
[0016] The handpiece 102 may include a light guide or crystal 120
for directing the light energy. Handpiece 102 may include an
internal light source which is controlled by the control console
110. Internal light sources may be of different types such as LEDs,
lamps, diode lasers, fiber lasers or solid state lasers, to name
but a few. Multiple sources, whether from the same type or from
different types, may be combined into a single handpiece. Light
sources located within handpiece 102 have the advantage of using
multiple simple umbilical sheaths 108 lacking optical components.
In yet another configuration, external light sources may be used.
External light sources may be solid state lasers, fiber lasers or
gas lasers which may be located in control console 110. In this
embodiment, of external light sources, requires the use of an
umbilical sheath 108, which among other things, can deliver the
light energy from control console 110 to the handpiece 102.
[0017] The handpiece 102 may include a conduit/cavity 116
configured to guide the light or accommodate a light guiding
element. Different types of light energy sources, such as those
mentioned above, may be guided and delivered onto the target tissue
in different manners. In one embodiment of the present invention,
the handpiece may include a lamp which is configured to generate an
intense pulsed light (IPL). In this embodiment a crystal light
guide 120 is placed within the handpiece conduit/cavity 116. The
crystal light guide 120 may have different lengths and cross
sectional geometry. The crystal light guide 120 may have a uniform
cross section or the cross section of the light guide 120 may be
tapered in order to increase the energy fluence at the spot of
treatment. The light guide 120 may also have the same shape and
cross section which best conforms to the target tissue area. For
example, the light guide 120 may have the same shape as the entire
target area so that a single pulse of light may cover the entire
treatment target area. A curved crescent-like shape is one which
may cover the entire lower eyelid. The light guide 120 may be
permanently affixed to the handpiece or may be removably affixed to
the handpiece to allow the physician to select the best light guide
120 suited for the patient and treatment area. The light guide 120
may be configured to establish a direct contact with the target
tissue or the light guide 120 may treat the target tissue without
direct contact. The same light guide 120 may be used in a contact
mode or a non-contact mode using an affixing mechanism which
supports both configurations.
[0018] The light guide 120 may also be configured as a hollowed
conduit to deliver light energy in free space to the target tissue.
In yet another configuration the light guide may comprise an
optical fiber or a bundle of optical fibers. The handpiece 102 may
be configured to move the optical fiber in a predetermined pattern
such that the fiber will scan at least a portion of the target
tissue. Or the handpiece 102 may be configured to scan a light beam
through free space over a target tissue using controllable optical
elements. A beam splitter may be used in order to create fractional
treatment to the target tissue.
[0019] The handpiece also includes a removable tip 104. In
particular, in some embodiments, the tip 104 is disposable. The
size and shape of the tip 104 may vary according to the size and
shape of the handpiece 102 to which it is attached. For example, in
some embodiments, the tip 104 is configured to be compatible with a
small handpiece configured for precise digital manipulation such as
the handpiece described in U.S. Pat. No. 7,886,748. However, it is
to be understood that other handpiece shapes and configurations can
be used in other embodiments. For example, a handpiece having a
shape and configuration similar to the handpiece described and
shown in U.S. Pat. No. 6,758,845 or U.S. Pat. No. D643530 can be
used in other embodiments.
[0020] The tip 104 is physically equipped with a shielding
extension 106 which provides protection of sensitive ocular organs.
For example, the shielding extension 106 may be configured to
create a mechanical separation of the target tissue (e.g. an
eyelid) from adjacent posterior structures (e.g. cornea or sclera)
and can be used by a medical professional to create an artificial
gap or distance between the respective tissues, as described in
more detail below. In addition, the shielding extension 106 is made
of or coated with thermally insulative materials that prevent
thermal energy from dissipating or transferring to other structures
which are not the intended target tissue. Furthermore, the tip 104
is made from materials that are biocompatible with ocular tissue
such as, but not limited to, collagen and polymer materials that
are known to one of skill in the art. Hence, the tip 104 presents
minimal to no risk of abrasive damage to the ocular tissue. FIG. 2
is a block diagram of another embodiment of a handpiece 202. In the
embodiment of FIG. 2, the control electronics 212, light source 215
and handpiece 202 are combined into a small stand-alone hand-held
unit. In such a configuration, the umbilical sheath 108 shown in
FIG. 1, may be integrated into the internal electronic circuits of
the system and circuitry of the handpiece 102. In addition, the
handpiece 102 includes a heat sink 217 that is thermally coupled to
the shielding extension 206 vai the support extension 218. In this
way, thermal energy can be dissipated via the tip 204 to the heat
sink 217. Alternatively, the heat sink 217 can be replaced with a
cooling source which is thermally coupled to the shielding
extension 206 via the support extension 216. In this embodiment,
the cooling source is able to cool tissue in contact with the
shielding extension 206.
[0021] An exemplary tip is described in more detail with respect to
FIG. 3. In the example of FIG. 3, the tip 304 comprises the
shielding extension 306, a support extension 318, and a hollow
conduit/cavity 316. The conduit/cavity 316 prevents accidental
contact with a laser guide or crystal in the handpiece used for
directing the light energy. In addition, in some embodiments, the
length 303 of the conduit/cavity 316 is configured as a distance
guide to aid in maintaining a predetermined distance between the
surface tissue to be treated and a given crystal in the handpiece.
For example, the desired distance between the tissue to be treated
and the crystal in the handpiece is dependent on the treatment to
be applied and/or on the characteristics of the crystal selected.
The length 303 of tip 304, therefore, is manufactured, in some
embodiments, to vary from one tip to another tip. Thus, for a given
treatment and/or crystal, a tip 304 is selected which has a length
303 that corresponds to the desired distance between the surface
tissue and the crystal for the given treatment and/or crystal. In
another embodiment of the present invention, a laser light is
delivered by handpiece 102 to target tissue via free space and
through a conduit in the handpiece and conduit 316 of the tip 304.
In this configuration the internal surfaces of the handpiece
conduit and the tip conduit 316 are configured to internally
reflect the passing light and to minimize energy loss.
[0022] In some embodiments in which the length 303 varies from one
to tip to another, the length 301 between the shielding extension
306 and the tube 316 is fixed for each tip. For example, the length
301 can be based on the average thickness of an upper or lower
adult eyelid. In other embodiments, the length 303 is fixed from
one tip to another and the length 301 varies to correspond with
desired distances between the surface tissue and the conduit
316.
[0023] The shielding extension 306 is configured to be inserted
between the ocular conjunctiva and the palpebral conjunctiva and to
extend to the fornix. Hence, the length 305 of the shielding
extension 306 is based on an average depth of an adult fornix in
some embodiments. In other embodiments, the length 305 of the
shielding extension can vary from one tip to another such that a
medical professional can select a shielding extension having a
length appropriate for a given patient. Since the shielding
extension extends to the fornix, the shielding extension 306 is
also referred to herein as a fornix shield.
[0024] In addition to the thermal properties discussed above, the
shielding extension 306 is configured to be sufficiently flexible
that it can be deformed to define irregular surfaces when inserted.
For example, it can deform to the contours of the ocular tissue of
a given patient. Thus, the shielding extension 306 is able to
prevent energy not absorbed by the target area from reaching tissue
behind the target area. In addition, although the angle 307 between
the shielding extension 306 and the support extension 318 is
depicted as a right angle in FIG. 3, it is to be understood that
angle 307 is not limited to a right angle. For example, the angle
307 can change when tip 304 is used due to the deformation of
shielding extension 306. In addition, as shown in FIG. 4, the angle
407 formed between the shielding extension 406 and the support
extension 418 can be configured with an angle other than
90.degree..
[0025] In some embodiments, the shielding extension 506 may also be
constructed from at least two layers, as shown in FIG. 5. Each
layer 522-1 and 522-2 has different characteristics. In one
embodiment of the present invention, the first layer 522-1 is a
proximal layer to the handpiece and the second layer 522-2 is a
distal layer of the shielding extension 506. The distal layer 522-2
is configured to be in direct contact with posterior organs to be
protected such as cornea or scleara. The proximal layer 522-1 is
configured to be in contact with the eyelid. In one embodiment of
the present invention, the distal layer 522-1 may have high thermal
insulative properties while the proximal layer 522-2 may have high
thermal conductivity properties and a low thermal capacity. In this
configuration, the proximal layer 522-2 may be used to dissipate
thermal energy passed through the eyelid and reach the shielding
extension 506. For example, the thermal energy can be dissipated
via the shielding extension 506 and support extension 518 to a heat
sink reservoir located in the handpiece to which it is thermally
coupled. In yet another embodiment, the handpiece 102 may include a
cooling source thermally coupled to the proximal layer 522-1 of the
shielding extension 506, in order to cool the target tissue. In
this embodiment, the distal thermally insulative layer 522-2
isolates and protect posterior organs from cooling energy.
[0026] FIG. 6 depicts an exemplary tip 604 in operation to protect
ocular tissue. As shown in FIG. 6, the shielding extension 606 is
inserted behind the lower eyelid between the conjunctiva lining the
lower eyelid (the palpebral conjunctiva) and the conjunctiva lining
the sclera (the ocular conjunctiva). The shielding extension 606 is
being inserted toward the fornix. Hence, the shielding extension
606 is able to protect the sclera and the cornea from energy not
absorbed by the target tissue in the lower eyelid. In addition, the
shielding extension 606 is sufficiently rigid that it can be used
to apply a slight force that separates the lower eyelid from the
sclera and cornea. Hence, a physical gap is created between the
lower eyelid and the sclera/cornea. This physical gap acts as a
thermal insulation barrier that provides additional protection from
thermal energy. Notably, although the shielding extension 606 is
inserted behind the lower eyelid in this example, it is to be
understood that the shielding extension 606 can also be inserted
behind the upper eyelid.
[0027] FIG. 7 is a flow chart depicting one embodiment of a method
700 of protecting ocular tissue. Method 700 is implemented using a
handpiece having a tip with a shielding extension such as tip 304
described above. At block 702, a removable tip having a shielding
extension is attached to a handpiece. At block 704, the distal end
of the tip is inserted to the posterior side of an eyelid (e.g. the
lower eyelid), in the area between the conjunctiva-covered sclera
and the conjunctiva-covered inferior eyelid, until it reaches the
fornix, as described above. At block 706, a force is optionally
exerted on the tip to pull the palpebral area anteriorly, thereby
creating a physical separation of the eyelid from the anterior
surface of the eye globe. At block 708, external eye shielding,
such as eye shielding described in U.S. Pat. No. 7,886,748, is
optionally applied over the non-treated areas of the skin in the
ocular and/or periocular areas to provide a second layer of
protection.
[0028] At block 710, the handpiece delivers light to the ocular
and/or periocular treatment areas, such as on an external surface
of the eyelid. The handpiece is configured to generate the heat
needed for a given treatment. For example, the light can be used to
treat a variety of ophthalmic and/or dermatological conditions,
such as but not limited to, meibomian gland dysfunction (e.g. dry
eye), wrinkles, and lesions in the skin. The light applied by the
handpiece is determined based on the condition to be treated. For
example, the heat generated to treat meibomian gland dysfunction is
generated at a level sufficient to stimulate the meibomian gland
and/or decrease palpebral telangiectasia. Thus, the level of heat
for treating meibomian gland dysfunction is not necessarily the
same as the level to remove wrinkles. In either case, the shielding
extension provides thermal protection to the ocular tissue behind
the target treatment tissue. In addition, the physical separation
created by force exerted on the tip adds another level of
protection to the ocular tissue. Thus, the embodiments of the tip
described herein provide increased protection of ocular tissue.
Furthermore, the tips provide a hygienic solution for protecting
the sensitive ocular tissue due to the single-use disposable
characteristic of the tip in some embodiments.
[0029] Although specific embodiments have been illustrated and
described herein, it will be appreciated by those of ordinary skill
in the art that any arrangement, which is calculated to achieve the
same purpose, may be substituted for the specific embodiments
shown. Therefore, it is manifestly intended that this invention be
limited only by the claims and the equivalents thereof.
* * * * *