U.S. patent application number 14/686049 was filed with the patent office on 2015-10-29 for systems and methods to deliver photodisruptive laser pulses into tissue layers of the anterior angle of the eye.
This patent application is currently assigned to Fs-Eye, LLC. The applicant listed for this patent is Christopher Horvath, Vanessa I. Vera. Invention is credited to Christopher Horvath, Vanessa I. Vera.
Application Number | 20150305940 14/686049 |
Document ID | / |
Family ID | 46966665 |
Filed Date | 2015-10-29 |
United States Patent
Application |
20150305940 |
Kind Code |
A1 |
Vera; Vanessa I. ; et
al. |
October 29, 2015 |
SYSTEMS AND METHODS TO DELIVER PHOTODISRUPTIVE LASER PULSES INTO
TISSUE LAYERS OF THE ANTERIOR ANGLE OF THE EYE
Abstract
The invention relates to systems and methods for accessing
tissue layers of the anterior chamber angle of an eye, targeting
one or multiple treatment zones within the anterior angle area of
the eye and delivering focused photodisruptive laser pulses with
pulse durations <50 picoseconds creating channels into various
anatomical structures within the anterior angle of the eye.
Inventors: |
Vera; Vanessa I.; (Mission
Viejo, CA) ; Horvath; Christopher; (Mission Viejo,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Vera; Vanessa I.
Horvath; Christopher |
Mission Viejo
Mission Viejo |
CA
CA |
US
US |
|
|
Assignee: |
Fs-Eye, LLC
Mission Viejo
CA
|
Family ID: |
46966665 |
Appl. No.: |
14/686049 |
Filed: |
April 14, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13442854 |
Apr 10, 2012 |
9033963 |
|
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14686049 |
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Current U.S.
Class: |
606/6 |
Current CPC
Class: |
A61F 9/009 20130101;
A61F 2009/00868 20130101; A61F 9/00825 20130101; A61F 9/00781
20130101; A61F 2009/00891 20130101; A61F 9/00821 20130101 |
International
Class: |
A61F 9/008 20060101
A61F009/008 |
Claims
1. A third method of delivering photodisruptive laser pulses into
targeted tissue layers of the anterior angle of the eye using a
sequence of cutting circles that progress from large to small and
with varying z-depths, selected spot separation, layer separation
and position relative to the target zone that create a channel
opening through the targeted tissue layers.
2. A method of claim 1 where the areas within the cutting circles
are treated with photodisruptive laser pulses following a
repetitive sequence.
3. A method of claim 1 where the cutting circles are
elliptical.
4. A method of claim 1 where the channel cutting procedure is ended
by a sequence of laser pulses that are scanned back and forward
along the central z-axis of the treatment zone.
5. A method of claim 1 where the first cutting circle is placed
below the surface of the target tissue area.
6. A method of claim 1 where the cutting circles change from small
to large during the progression of the cutting sequence.
7. A method of claim 1 where the laser pulse sequence is repeated
multiple times at different target locations to create multiple
channel openings.
8. A method of claim 1 where the diameter of all cutting circles is
0 and therefore every circle effectively becomes a spot.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a division of application U.S. Ser. No. 13/442,854
filed on Apr. 10, 2012. This application further claims the benefit
of the U.S. provisional application No. 61/473,806, filed Apr. 10,
2011, the content of which is considered incorporated by reference
herein in its entirety. To the extent the following description is
inconsistent with the disclosure of the provisional application,
the following description controls.
BACKGROUND OF THE INVENTION
[0002] Lasers have been used for several decades in the treatment
of glaucoma. The 2 most common laser treatments for primary open
angle glaucoma (POAG) are ALT (Argon Laser Trabeculoplasty) and SLT
(Selective Laser Trabeculoplasty). See for example U.S. Pat. Nos.
3,884,236; 8,066,696; 5,549,596; 6,319,274. They work by applying
laser pulses into the Trabecular Meshwork (in the anterior angle of
the eye). These laser pulses are focused to around 50 micrometer
diameter for ALT and around 400 micrometer for SLT. Those laser
spots are targeted to lay over Schlemm's canal and cause an
increased outflow through the treated Trabecular meshwork area. In
both procedures at least 180 degrees of the eye angle is treated
with typically 50 to 100 laser pulses (each pulse is applied to a
new target zone-treatment area). The working mechanism for ALT is
blanching of the Trabecular meshwork that increases the outflow by
stretching the Trabecular Meshwork between the blanched (laser
treated areas). The ALT laser with a typical setting of 600 mW and
0.1 s pulse duration (at 514 nm or 532 nm) causes a thermal tissue
interaction. In SLT treatment the laser causes cavitation bubbles
in the target tissue due to its shorter pulse duration of about 3
nanoseconds and higher peak power (created by pulse energies of
around 0.3 mJ to 1.6 mJ).
[0003] Both procedures have a good success rate by increasing
aqueous humor outflow that creates a substantial drop in
intraocular pressure of around 20%. Both procedures can be
performed in minutes with a simple slit lamp procedure in the
office (no OR visit required). In both procedures, the eye does not
need to be opened (non-invasive procedure), therefore the treatment
risks and complication rates are minimal. The problem of these
procedures as published in many studies is that it does not work
effectively in all patients and in the successful cases the effect
wears off over the course of a few (1-3 years) and the IOP rises
back to its baseline level. The procedure can be repeated once with
ALT and 2-3 times with SLT, but after those repeats the tissue
damage in the Trabecular meshwork that is created through those
multiple procedures ultimately prevents any further IOP lowering
effect.
[0004] A less frequently used laser procedure called ELT (Excimer
Laser Trabeculostomy) uses an Excimer laser pulse (wavelength in
the UV range) to actually drill holes into the Trabecular Meshwork.
See for example U.S patent applications: 20080082078; 20040082939.
Because complete openings are created to Schlemm's canal (unlike
ALT and SLT), the IOP lowering effect is similar or better than
ALT/SLT and in the same time only a few open holes need to be
drilled with ELT versus 50-100 treatment zones in a typical ALT/SLT
procedure. Some studies further suggest that the ELT effect is
longer lasting then ALT/SLT due to some observed long term patency
of those holes. Furthermore ELT might be repeated more often since
a smaller area of the Trabecular Meshwork is treated each time. The
downside of ELT is the fact that UV wavelength light does not
penetrate the cornea and aqueous humor, therefore the laser can
only be applied to the Trabecular Meshwork in an operating room
procedure, where the eye is opened and a fiber probe is inserted
into the anterior chamber all the way up to the Trabecular
Meshwork.
[0005] In recent years the effectiveness of having one or multiple
holes in the Trabecular Meshwork (connecting to Schlemm's canal)
has also been demonstrated with several implants, placed through
the Trabecular Meshwork that create an opening into Schlemm's
canal. See for example U.S patent applications: 20120071809,
20070276316. Those are however also invasive (full operating room)
procedures using an implant.
[0006] Another approach to drain aqueous humor out of the anterior
chamber has been successfully demonstrated by implanting a drainage
tube through the scleral spur region and into the suprachoroidal
space. See for example U.S patent application: 20110098629. This is
however also an invasive (full operating room) procedures using an
implant.
[0007] Most recently, there have been animal tissue studies
applying ultrashort photodisruptive laser pulses to the trabecular
meshwork with limited success. Hiroshi Nakamura et. al.
Investigative Ophthalmology & Visual Science, March 2009, Vol.
50, No. 3. Performed an ex vivo study on primates delivering
photodisruptive laser pulses into the anterior angle of the eye. He
presents several limitations and challenges in the paper concerning
the goal of creating a hole through the Trabecular Meshwork. These
limitations and challenges have so far prevented a successful use
of such a non-invasive laser procedure in the angle of the eye.
[0008] The inventions described herein relate to a new devices and
methods to overcome those limitations and challenges and therefore
allow the creation of holes and channels in the Trabecular Meshwork
and other places in the angle of the eye in a non-invasive
procedure that can be repeated as many times as necessary.
[0009] Other examples of related prior art are U.S. Pat. Nos.
8,056,564; 4,391,275; 5,288,288; 7,912,100
BRIEF SUMMARY OF THE INVENTION
[0010] Photodisruptive laser pulses in the range of <1000
femtoseconds have been successfully applied to make incisions into
various tissues of the eye. The main focus to date has been using a
femto second laser for various cornea incisions such as LASIK
flaps, intrastromal incisions, Limbal Relaxing Incisions,
Keratoplasties and cornea entry incisions. In more recent years
femtosecond lasers have also been successfully applied to the
capsule and the lens of the human eye in femtosecond laser assisted
cataract procedures.
[0011] The main benefit of these photodisruptive laser pulses lays
in the fact that the eye tissues, that are treated transmit the
wavelengths of the typically chosen lasers, usually in the near
infrared or visible range and therefore allow the laser to be
focused through the cornea, aqueous humor, lens capsule and lens
without much scattering or absorption. The laser pulses are always
focused to a very small spot size in the range of a few
micrometers, where a laser induced optical breakdown is achieved in
any tissue or liquid (e.g. aqueous humor) that falls within the
spot size location.
[0012] This optical breakdown (photodisruptive breakdown) creates a
micro plasma followed by a small cavitation bubble, which can be
used to cut and dissect tissue areas of any size and shapes by
scanning a sequence of many such laser pulses over a desired volume
in the eye.
[0013] Since the tissue layers in the laser path above and below
the focus point are below the optical breakdown threshold and since
they mostly the laser wavelength, they remain unaffected by the
laser beam. This principle allows non-invasive photo disruptive eye
surgery since no incision from the outside needs to be made.
[0014] There is a threshold of a minimum laser fluence (laser peak
power divided by focus area) required to achieve the optical
breakdown. The laser peak power goes up no with higher pulse energy
(typically in the .mu.J range) and shorter pulse duration
(typically <600 fs). The laser fluence for any given peak power
goes up as the focus area goes down. Achieving a small spot size is
therefore critical in achieving a high fluence that exceeds the
optical breakdown threshold.
[0015] The way of achieving a high enough fluence for breakdown by
increasing the us laser pulse energy is less desirable since a
higher pulse energy comes with a larger cavitation bubble and
associated shock wave. The larger the cavitation bubble the less
precision is achieved in cutting any features with a sequence of
pulses. Furthermore a large shock wave is considered a undesired
side effect since it has the potential to damage surrounding
tissues.
[0016] Priority is therefore given to minimizing the spot size to
achieve an above threshold laser fluence while using laser pulses
within a low pulse energy range of <50 .mu.J per laser
pulse.
[0017] These principles have been successfully implemented in femto
second eye laser systems treating the cornea or capsule/lens of an
eye. The laser delivery systems can achieve good focusing access to
the cornea and lens through large focusing lens assemblies
positioned within a few cm above the eye. Typical laser beam
focusing convergence angles achieved are numerical apertures of
NA>0.15 (full angle .THETA.>15 deg) and in some optimized
cases NA>0.3.
[0018] According to: Formula 1
.THETA. = M 2 360 .lamda. .pi. 2 .omega. 0 ##EQU00001##
[0019] .THETA.=full focusing convergence angle in degrees
[0020] .lamda.=laser wavelength
[0021] .omega.=laser beam focus radius defined by 1/e.sup.2 cut
off
[0022] M.sup.2=beam quality factor determined by the total
aberrations
[0023] If beam aberrations can be kept to a minimum e.g.
M.sup.2<1.3 (M.sup.2=1 is the theoretical minimum with no
aberration at all) then the above focusing angles of NA>0.15
(.THETA.>15 deg) and NA>0.30 (.THETA.>30 deg) the
resulting spot size diameters (2 .omega..sub.0) will be <8 .mu.m
and <4 .mu.m respectively (for a laser wavelength .lamda.=1
.mu.m).
[0024] The minimization of aberrations is critical in achieving
such small spot sizes.
[0025] The tissue layers in the cornea and lens/capsule are
relatively easy accessible for any laser beam from the outside.
[0026] Due to the fact that the existing systems focused laser
beams enter the eye in a straight vertical line that is
perpendicular to the central area of the cornea (and top surface of
any used patient interface) the aberrations can be kept small
enough to allow small spot sizes. Such femtosecond cornea and
lens/capsule systems typically reach beam quality factors of
M.sup.2<2.
[0027] The same easy access is not available for reaching the
anterior camber angle tissue layers of the eye with a highly
focused laser beam.
[0028] Furthermore the tissue layers in the anterior angle of the
eye contain blood vessels that will start bleeding when hit or cut
by photo disruptive laser pulses.
[0029] Therefore, there are several limitations and considerations
that need to be overcome in order to deliver photo disruptive laser
pulses to the anterior angle of the eye. Very limited success has
been demonstrated so far in reaching these tissue layers (e.g.
Trabecular Meshwork or scleral spur) with the goal of applying a
laser pulse sequence that can create a drainage channel (hole) into
and through those tissue layers.
[0030] Accessibility consideration factors for a highly convergent
focused laser beam targeting the tissue layers of the anterior
chamber angle:
[0031] Eye Anatomy:
[0032] The eye anatomy see FIG. 9 restricts the angular
accessibility of the anterior angle (e.g. Trabecular Meshwork 3104)
particularly in the vertical plane (defined here as a plane that
includes the z-axis going centrally).
[0033] FIG. 3 shows a histology picture of the anterior angle in
such a vertical cut. This eye shows a rather narrow angle of only
20 degrees. Typical angles in human eyes (including Primary Open
Angle Glaucoma--POAG) are between 30 and 50 Degrees.
[0034] This vertical plane (vertical angle axis) represents the
most restricted axis in terms of angular accessibility since the
tangential access plane (the plane that includes the rim of the
Trabecular Meshwork--perpendicular to the vertical plane) has a
somewhat larger accessibility angle.
[0035] There are further factors limiting angular access to the eye
(particular the already critical vertical plane).
[0036] Eye Geometry Variations:
[0037] The anterior angle accessibility varies widely from eye to
eye. For example in highly myopic eyes the angle can be larger than
45 Degrees, while it becomes more narrow in Hyperopic eyes. FIG. 4
shows a more average 40 degree angle opening 3015.
[0038] Other Factors and Limitations of Anterior Angle Angular
Access:
[0039] Total Internal Reflection, Gonioscopy Lens Requirement:
[0040] Due to the geometry of the cornea and anterior angle the
light rays out of the anterior angle cannot exit the cornea due to
total internal reflection. An optical interface with a similar
index of refraction is therefore required on top of the cornea.
This is called a gonioscopy lens (from here on referred to as a
gonio lens). This invention includes several new gonio lens
variations and designs that address and solve besides other
features the wide angle laser delivery issues and limitations. FIG.
5 and FIG. 6 illustrate these principals.
[0041] Beam Aberrations:
[0042] The focusing laser beam has to go through several interfaces
such as gonio lens, goniogel, cornea and aqueous humor. There are
numerous cases of beam aberrations limiting the focusing power due
to:
[0043] The wavefront of the beam hits many of those interfaces at
high angles which is prone to cause astigmatism and higher order
aberrations.
[0044] The interfaces curvatures such as the cornea vary from eye
to eye and are not aberration free, especially at shallow incidence
angles. The most upper vertical beam limit line runs at some point
almost parallel to the cornea and endothelial cell layer. This
causes significant aberrations in that part of the focusing laser
beam. See for example FIG. 10.
[0045] The sagittal and tangential (vertical and horizontal) planes
are exposed to significant different aberrations due to different
interface curvatures in their respective planes.
[0046] The sagittal and tangential planes have different focusing
requirements as discussed above (see FIG. 7) and therefore also
experience different levels of aberrations.
[0047] All these factors need to be considered in the design and
the methods of a delivery system, that can meet the small focusing
requirements at the anterior angle. This invention addresses those
limitations.
[0048] The limitations that need to be addressed and overcome can
be summarized into the following categories:
[0049] The anatomical limitations of the human eye, in particular
the relatively narrow access angle to the Trabecular Meshwork
between the iris and the cornea are limiting the maximal possible
focusing angle in that dimension. Furthermore human eyes show a
great range of variability in this anatomical angle. In particular
the last 1-2 mm before the actual chamber angle has great access
variability between 0 deg (in case of a closed angle) to 50 deg
opening based on the exact iris position.
[0050] Often the last 1 mm distance approaching the anterior angle
from the center of the anterior chamber is hard to visualize even
with a gonio lens a and can close off very rapidly due to iris
synechia and iris bulging.
[0051] The laser beam cannot enter the eye perpendicular, but
rather enters the cornea under a shallow and at some outer beam
limits at an almost parallel angle. This dramatically increases the
amount of aberrations that the laser beam wave front experiences
during the beam propagation into the eye. Furthermore any contact
interface and gonio lens that applies pressure to the cornea will
induced aberrations such as cornea wrinkles that need to be
overcome and/or compensated for.
[0052] The target region contains tissues of varying absorption and
optical breakdown threshold characteristics since there is a great
patient variability in pigmentation and presence of blood vessels
or blood itself. These variations create large variability in the
photo disruptive breakdown threshold fluency of the laser-tissue
interactions and need to be considered and compensated for.
[0053] Due to total internal reflection, the angle is not directly
accessible without the use of a gonio lens. A specific gonio lens
design is required to minimize aberrations, allow for sufficient
eye fixation and most importantly to allow transmission of a highly
convergent laser beam as described above.
[0054] To allow integration of a gonio lens into a laser delivery
system a patient interface with specific features is required.
[0055] The present inventions provides a method for overcoming the
limitations described above. In particular the invention provides
the following method:
[0056] A third method for delivering a particular pulse sequence of
circular or elliptical spot size femtosecond laser pulses to create
a hole(s) or channel(s) into the tissue layers of the anterior
angle of an eye. The method describes a scanning pattern that can
for example be applied during the laser firing in the first method
step e. or the second method step f. to create the hole and channel
into the desired target tissue layers. Method to target the
treatment zone(s) using one or multiple lasers.
BRIEF DESCRIPTION OF THE DRAWINGS
[0057] FIG. 1 illustrates a laser focus with a 3 .mu.m diameter and
a 20 deg convergence angle
[0058] FIG. 2 illustrates a laser focus with a 3 .mu.m diameter and
a 40 deg convergence angle
[0059] FIG. 3 illustrates a 20 deg laser focus into the anterior
angle region of an eye
[0060] FIG. 4 illustrates a 40 deg laser focus into the anterior
angle region of an eye
[0061] FIG. 5 shows the concept of total internal reflection
[0062] FIG. 6 illustrates a laser beam path using a direct gonio
lens
[0063] FIG. 7 shows a simulated laser beam with different focusing
characteristics in the horizontal and vertical axis
[0064] FIG. 8 illustrates a laser focus being scanned back and
forward across a tissue interface
[0065] FIG. 9 shows the anatomical features of the anterior angle
of an eye
[0066] FIG. 10 illustrates a large photocoagulation zone due to a
defocused laser beam
[0067] FIG. 11 shows a aiming beam and treatment laser beam
focusing into the angle
[0068] FIG. 12 illustrates an alignment motion for an aiming laser
beam
[0069] FIG. 13 shows a circular laser firing pattern in the
anterior angle tissue layers
[0070] FIG. 14 shows a corkscrew laser firing pattern in the
anterior angle tissue layers
[0071] FIG. 15 shows a elliptical photocoagulation zone in the
angle of an eye
[0072] FIG. 16 shows a detailed delivery system design
[0073] FIG. 17 illustrates a detailed patient interface design
[0074] FIG. 18 shows a detailed laser shaping optical delivery
system component design
[0075] FIG. 19 shows a detailed laser shaping optical delivery
system component design
[0076] FIG. 20 shows a detailed laser shaping optical delivery
system component design
[0077] FIG. 21 shows a detailed laser shaping optical delivery
system component design
[0078] FIG. 22 illustrates a full system block diagram
[0079] FIG. 23 illustrates a laser firing pattern
[0080] FIG. 24 illustrates a laser firing pattern
[0081] FIG. 25 illustrates the laser beam path of a specific mirror
gonio lens
DETAILED DESCRIPTION OF THE INVENTION
[0082] The word "fs-laser" throughout this disclosure stands for
femtosecond laser and is meant to cover any laser source, that can
provide pulse durations smaller than <50000 femtoseconds (50
pico seconds) with a preferable range of 10 fs to 500 fs. The word
femtosecond can also be interchanged with the word photodisruptive
throughout the entire disclosure. This ultra-short pulse
requirement together with a small spot size area (preferably <20
.mu.m for circular focus and preferably <400 .mu.m.sup.2 for
elliptical focus) allows the use of very small pulse energies in
the range of <200 micro Joules (preferable range <50 micro
joules) while still achieving a photodisruptive (plasma induced
optical breakdown) tissue reaction that allows for the creation of
a hole (tunnel) in tissue layers in the anterior angle of the eye
(e.g the Trabecular Meshwork). FIG. 9 shows the anatomical features
of the anterior angle area of the eye. It is critical to keep the
pulse energies small since the undesired side effects such as
shockwaves and large cavitation bubbles scale with the pulse
energy, reduce precision and cause increasing collateral tissue
damage around the desired target zone.
[0083] FIG. 1. The small focus requirement leads to a large
focusing beam convergence angle (high numerical aperture NA) in the
range of 10-90 degrees. A 3 .mu.m spot size diameter of a
.lamda.=1060 nm fs-laser beam with an aberration free beam quality
factor of M.sup.2=1 requires about 20 degrees (1/e 2) of full
convergence (often referred to as beam divergence) angle as can be
seen in the simulated coherent laser beam 3003 horizontal and 3006
vertical propagation calculation of FIG. 1.
[0084] Because of significant wave front distortions of the laser
beam, as it propagates through various optical and eye anatomical
interfaces the coherence quality of the wave front is reduced
resulting in a larger spot size. To maintain the same small spot
size in the example above the full convergence angle to reach a 3
.mu.m spot size diameter goes up to about 36 degrees (for an M 2 of
1.8) as shown in the simulation in FIG. 2.
[0085] Furthermore these theoretical values are defined as a 1/e 2
beam cut off value. If the beam had only exactly that room to
propagate and anything outside this envelope would be cut off, then
that would result in a larger focus and lost pulse energy due to
clipping.
[0086] To prevent this additional aberration and energy loss it is
important to allow another 5-10 degrees of accessible angle to
prevent excessive clipping and to allow for some misalignment
margin.
[0087] The present invention provides a method for overcoming the
limitations described above. In particular the invention provides
the following third method (as named in the parent
application):
[0088] A first method (reference only) to optimize the fs-laser
beam parameters to reach, target and create holes into the tissue
layers of the anterior angle of the eye: This will address the
highly variable (eye to eye and setup to setup related) beam
aberration variations and geometrical angle size variations of the
anterior angle from eye to eye. This method is described in the
following steps from a. to f. [0089] a. (Optional) When a laser
delivery system with an adjustable beam convergency angle is used,
pre-measured patient data of the anterior angle access angle e.g.
through OCT (optical coherence tomography) before treatment is used
to course adjust the vertical beam axis convergence angle (and
horizontal axis in same way for circular focus version) to roughly
match the accessible angle. [0090] b. Use a delivery system with a
fixed beam full convergence angle of 30 to 60 deg if circular or
30-60 deg in the vertical axis and 40-90 degrees in the horizontal
axis if elliptical. The preferred full convergence angles are 40
deg (+/-5 deg) in both axis if a circular beam is delivered and 40
deg (+/-5 deg) in the vertical axis and 70 deg (+/-10 deg) in the
horizontal axis if a delivery system is used that allows elliptical
focusing. For most eyes with open angles these preferred settings
will achieve a spot size at the anterior angle tissue layers that
is close to a practical minimum. For eyes with partially closed
angles <45 deg in the vertical access angle, the preferred
settings will overfill the accessibility angle and this will result
in some partial laser beam clipping in the vertical axis. The laser
focus is then targeted into the desired tissue layer surface in the
anterior angle of the eye and once the laser focus targeting has
been completed the laser starts firing at a low pulse energy
preferably <10 .mu.J. These probing laser pulses below the
plasma breakdown threshold are then successively increased in pulse
energy until first optical breakdown cavitation bubbles are
detected (preferably by a vision system). [0091] c. (optional) see
FIG. 8. The focusing lens and therefore the laser focus is scanned
back 3031 and forward 3030 (preferably +/-<750 .mu.m in z-axis
3029 while pulse energy is being increased in the sequence under b.
to: assure the detected threshold happened on the surface of the
targeted anterior angle tissue (e.g. Trabecular Meshwork) or
closely below and not in the aqueous humor and to: calibrate the
actual z-distance of a laser delivery system reference point (e.g.
upper patient interface plane) to the surface of the targeted
tissue layer in the anterior angle (e.g. trabecular meshwork
surface). [0092] d. (optional) Once the threshold has been
determined as described in step b. (and optional the z-calibration
in step c.) the same laser beam is preferably automatically
defocused by a predetermined amount using a z-scan of the focusing
lens or other lens in the delivery system. The preferred defocusing
adjustment moves the laser focus 0.7 mm (+-0.5 mm) deeper into the
target tissue (towards or into the sclera). This results in an
enlargement of the laser beam diameter on the target tissue
(surface of the anterior angle tissue layer) to about 500 .mu.m
FIG. 10, 3201 for a laser beam with a circular convergence angle of
40 deg 3203. After this defocusing adjustment 3202, resulting in a
focus position in 3200, the pulse energy is automatically adjusted
higher. This pulse energy is adjusted to a level such that the
resulting average laser power P.sub.average power=E.sub.laser pulse
energyR.sub.laser repetition rate times the applied laser on
duration time during this defocused sequence provides an amount of
total energy E.sub.total=P.sub.average powert.sub.laser on duration
that photo coagulates the tissue area within the defocused
diameter. For a preferred laser repetition rate >100 kHz and a
preferred circular area of a 500 .mu.m diameter beam and a
preferred laser on duration of <1 s the preferred laser pulse
energy is >10 .mu.J. Lower available pulse energy can be
compensated by increasing the laser on duration to achieve the
desired amount of photocoagulation. The laser beam area for this
defocused large beam (e.g. 500 .mu.m circular diameter) is
typically >1000 times larger than typical achieved laser focus
on the same surface without defocusing (e.g. 10 .mu.m circular
diameter). Therefore any conceivable rise in pulse energy (even to
e.g. as high as >500 .mu.J) would still be far below the plasma
threshold energy on this large area. Furthermore the new laser
focus 0.7 mm below the anterior angle tissue layer surface is,
because of significant photon scattering and absorption of the
tissue layers between the surface layer and the 0.7 mm deep layer
no longer reaching the fluency level required to exceed the plasma
breakdown threshold. All laser power is therefore now absorbed and
scattered creating a thermal effect in and around the defocused
beam zone leading to photocoagulation versus a photodisruptive
cutting effect. The penetration depth of the coagulated tissue
volume depends beside the total delivered laser energy also on the
laser wavelength. The achieved coagulation zone (volume) reduces or
prevents any bleeding from the high fluency (above threshold) laser
pulses that follow this step (see step e.) and create a hole or
channel into the tissue layers. For a typical photodisruptive
(ultra short pulsed) laser wavelength around 1050 nm (+-50 nm) the
absorption length is longer than for shorter wavelengths such as
used for example in a 532 nm coagulation laser (similar to SLT and
ALT). Such a shorter wavelength, quasi cw (continuous wave) laser
with a preferred wavelength of 532 nm or 577 nm or 810 nm can be
used as a second laser source instead of the defocused
photodisruptive main laser. In that configuration the second source
shorter wavelength laser does not need to be focused in a highly
converging beam since it only needs to reach a preferred spot size
diameter of 500 .mu.m (+-300 .mu.m). Furthermore, if another laser
is used for the photocoagulation part, than that part of the
procedure can be performed before the non-invasive photodisruptive
laser procedure. For example the coagulation of one or multiple
treatment zones can be performed minutes or days before the channel
creating procedure on a laser slit lamp setup. All the above
parameter considerations for a preferred circular laser beam are
also applicable to a preferred elliptical laser beam. [0093] e.
Once the threshold pulse energy is known from step b. and optional
z-calibration from step c. and the optional photocoagulation (step
d.) is completed, the laser will preferably automatically adjust
the treatment pulse energy in a preset way relative to the
threshold energy (preferably 3.times. to 10.times. the threshold
energy) and preferably automatically fire a preset scanning pattern
to create one or multiple holes into the desired target zone layers
(e.g. through the Trabecular Meshwork or into the suprachoroidal
space) within the coagulated zone, if created. [0094] f. (optional)
All steps b. to e. are preferably done in a fully automated
sequence immediately following each other and parameters are
optimized such that the entire laser procedure time is preferably
less than 10 s.
[0095] A second method (reference only) to measure and maximize the
vertical angular laser beam access and therefore achieving minimal
spot size at the anterior angle tissue layers of an eye. The
horizontal convergence angle of the treatment laser beam is fixed
to preferably 60 deg (+/-20 deg) to create a small spot size in the
horizontal axis in the range of <10 .mu.m diameter depending on
the overall aberrations.
[0096] Step a. The angular opening in the vertical axis is
determined with the same femtosecond laser delivery system just
prior to firing the photodisruptive femtosecond laser pulses by
using a shape adjustable visible aiming laser beam under live
observation. FIG. 11 shows an aiming laser beam 3204 being focused
collinear to the planned photodisruptive treatment beam 3206 into
the target tissue layer of the anterior angle of the eye. In one
embodiment, this is done by changing the vertical aiming beam
divergence from big to small until no light is clipping on the iris
and cornea (both sides of the angle) or doing it reverse (small to
big) until light starts to scatter on the outside surfaces of the
angle. FIG. 11 shows the lower aiming beam envelope clipping on the
iris 3205. This scattered light feedback can be observed live by
the surgeon/operator or by an automated video/sensor analysis
system. While the beam cone is maximized, in the same time the
delivery system is preferably constantly adjusted for centration in
the angle of the eye to center the focusing beam cone in the angle
to achieve the setting of a maximum allowable vertical angle. This
adjustment is illustrated in FIG. 12 The beam 3210 is moved in the
directions 3211.
[0097] Step b. Once the maximum vertical accessibility angle to the
target region has been determined the aiming beam is scanned back
and forward in the z-axis (above and below the target tissue plane)
using a delivery system moving lens (e.g. the main focusing lens)
until the visible beam diameter on the target tissue layer is
minimized. This minimum spot visualization can be performed live by
observation of the surgeon through a microscope or preferably by an
automated vision system. The now known z-position of the delivery
system optics is now used to calibrate the z-distance of a delivery
system reference point to the aiming beam focus position on the
surface of the target tissue layer.
[0098] Step c. (optional) If the delivery system allows the
adjustment of the vertical beam convergence angle for the
photodisruptive treatment beam, then the vertical angle is now
adjusted to match the maximum determined aiming beam angle from
step a. This sets the treatment beam up to achieve a minimum
possible vertical spot size on the target tissue layer.
[0099] Step d. (optional) Perform a coagulation step identical to
the first method step d.
[0100] Step e. The control system of the laser system now
calculates and then sets the optimal photodisruptive laser pulse
energy based on the input from step a., b. and c. before the
treatment laser is fired. The factors for this calculation are as
follows: If the vertical treatment beam angle is adjustable then it
has been set to the maximum vertical angle in step a. Since the
horizontal focusing angle is fixed, the horizontal spot size axis
is fixed as well .omega..sub.0 horizontal fixed. The vertical spot
size .omega..sub.0 vertical and therefore the spot size area A is
according to formula 1 inverse proportional to the maximum vertical
angle .THETA..
A spot size area .about. .omega. 0 horizontal fixed .omega. 0
vertical = .omega. 0 horizontal fixed M vertical 2 360 .lamda. .pi.
2 .THETA. vertical ##EQU00002##
with
.omega. 0 horizontal fixed = M horizontal 2 360 .lamda. .pi. 2
.THETA. horizontal ##EQU00003##
the spot size area A becomes: Formula 2
A spot size area .about. M horizontal 2 360 .lamda. .pi. 2 .THETA.
horizontal M vertical 2 360 .lamda. .pi. 2 .THETA. vertical
##EQU00004##
[0101] The required treatment pulse energy is: Formula 3
E.sub.pulse energy setting=c E.sub.threshold pulse energy
with E.sub.threshold pulse energy being the minimum pulse energy
required to achieve a photodisruptive optical breakdown on the
desired tissue layer and c being a factor by which the set pulse
energy needs to exceed the threshold pulse energy to achieve an
efficient photodisruptive tissue effect for cutting and drilling a
hole into the tissue layers. The preferred setting for c is 3 to
10. The threshold for the photodisruptive optical breakdown depends
on the laser fluency F, being: Formula 4
F threshold = E threshold pulse energy t pulse duration A spot size
area ##EQU00005##
Therefore: E.sub.threshold pulse energy=F.sub.thresholdt.sub.pulse
durationA.sub.spot size area or: Formula 5
E.sub.threshold pulse energy.about.A.sub.spot size area
Combining formula 2, 3 and 5 leads to: Formula 6
E pulse energy setting .about. cM horizontal 2 360 .lamda. .pi. 2
.THETA. horizontal M vertical 2 360 .lamda. .pi. 2 .THETA. vertical
##EQU00006##
If the vertical angle is not adjustable, then it has been set to a
fixed preferred angle of .THETA..sub.vertical=40 deg (+/-15 deg).
Depending on the measured maximum vertical accessibility angle in
step a. this fixed vertical angle .THETA..sub.vertical is either
smaller or larger than the maximum accessible angle. If it is
larger than the maximum accessible angle then a clipping factor
f.sub.clip needs to be considered that reduces the laser power on
target an enlarges the spot size in the vertical axis. Including
this clipping factor the laser control system calculates the
required pulse energy setting for the following laser treatment
according to Formula 7:
E pulse energy setting .about. f clip c M horizontal 2 360 .lamda.
.pi. 2 .THETA. horizontal M vertical 2 360 .lamda. .pi. 2 .THETA.
vertical ##EQU00007##
The beam quality factors M.sub.horizontal.sup.2 and
M.sub.vertical.sup.2 depend on the sum of all aberrations of the
laser system including the delivery system optics, patient
interface, patient contact lens (goniolens) the interface to the
eye and to some extend the condition of the cornea and anterior
chamber of the eye. Most of these beam quality factors are system
specific and are preferably calculated and measured. A high level
of accuracy in determining those quality factors is achieved by
performing photodisruptive laser threshold measurements using model
and cadaver eyes on the final laser system setup. The f.sub.clip
loss factor is also determined by performing photodisruptive laser
threshold measurements using model and cadaver eyes on the final
laser system setup. They are performed for a range (15 deg to 50
deg) of accessibility angles (step a.) and saved as a table within
the laser control system. Once the laser procedure has started and
the actual vertical accessibility angle has been determined in step
a, the control system looks up the corresponding f.sub.clip loss
factor and calculates the final laser pulse energy setting
E.sub.pulse energy setting according to formula 7.
[0102] Step f. After the control system sets the treatment laser
pulse energy, the laser will preferably automatically fire a preset
scanning pattern with reference to the laser beam alignment in step
a. and the z-calibration in step b. to create one or multiple holes
into the desired target zone layers (e.g. through the Trabecular
Meshwork or into the suprachoroidal space) within the coagulated
zone, if created.
[0103] Step g. (optional) All steps a. to f. are preferably done in
a fully automated sequence immediately following each other and
parameters are optimized that the entire laser procedure time is
preferably less than 10 s.
[0104] A third method for delivering a particular pulse sequence of
circular or elliptical spot size femtosecond laser pulses to create
a hole(s) or channel(s) into the tissue layers of the anterior
angle of an eye. The method describes a scanning pattern that can
for example be applied during the laser firing in the first method
step e. or the second method step f. to create the hole and channel
into the desired target tissue layers. The method is as
follows:
[0105] Step a. The beam (round or elliptical focus) will be scanned
in a circular pattern to create the hole and channel into the
desire target tissue layers. The preferred starting cutting circle
diameter is 250 .mu.m+/-100 .mu.m. The preferred spot separation is
10 .mu.m+/-7 .mu.m. The first circle is cut at a z-alignment that
brings the focus plane of the treatment laser beam within +/-10
.mu.m of the surface plane of the target tissue layer.
[0106] Step b. Several additional circles (preferably 10+/-7 more)
are being cut successively moving deeper into the tissue layers.
Each new circle is preferably focused 7 .mu.m+/-5 .mu.m deeper than
the last see FIG. 13 or the circles are continuously going deeper
into the tissue in a corkscrew type of scanning pattern, see FIG.
14 with the same slope (7 .mu.m deeper per revolution).
[0107] Step c. (optional) The laser focus plane is moved back up to
the original surface of the top tissue layer and the laser is now
scanned over the entire circle area in a raster or spiral pattern
with a preferred spot separation of 5 .mu.m+/-3 .mu.m. Similar to
step b the focus plane is then lowered by 7 .mu.m+/-5 .mu.m and the
same areal cutting is repeated. This is also repeated preferably 10
times.
[0108] Step d. The focus plane is moved back up to the original
surface plane of the top tissue layer and the laser is now repeats
the scan pattern from step but with a preferably 30 .mu.m+/-20
.mu.m reduced diameter. This means for the preferred case a new
concentric circle diameter of 220 .mu.m. Furthermore the amount of
cutting circles or corkscrew rotations is now increased by
preferably another 10 to a total of 20 circles. This results in a
preferred cutting cylinder depth of 20.times.7 .mu.m=140 .mu.m.
[0109] Step e. (optional) repeat step c. with a reduced diameter
and extended depth according to step d.
[0110] Step f. Repeat step d. and step c. while further reducing
the diameter and extending the cutting depth until the desired hole
or channel depth has been achieved. FIG. 24 shows an example of the
total scanning pattern after 3 cycles with different diameters
3709, 3708, 3707 and depths have been completed. The preferred
cutting channel depth for the Trabecular Meshwork are in the range
of 100 .mu.m to 300 .mu.m while the preferred channel length for an
access channel into the suprachoroidal space is between 400 .mu.m
and 3 mm. Other desired target areas will have other preferred
channel lengths.
[0111] Step g. (optional) The laser pulse energy is increased
(preferably by a factor of 2+/-0.8) and the laser is fired
preferably 10 times back and forward along the central z-axis of
the holes/channel with a scanning depth amount that is equal to the
hole/channel length. FIG. 23 shows the overlapping linear micro
destruction zones 3700 to 3706 of the individual laser pulses after
the first z-scan. 3300 represents the top tissue layer in the
anterior chamber angle region. This step clears any remaining
tissue debris out of the channel. This step can be repeated a few
times with a few seconds of pause in between to allow the
cavitation bubbles to disappear.
[0112] Step h. (optional) The cutting sequence described in step a
to step g creates a slight cone shaped channel getting smaller
diameter as the channel progresses deeper into the tissue layers.
This scanning sequence and cone angle can be reversed by starting
with the smallest circle diameter and going outwards while going
deeper.
[0113] Step i. (optional) The channel can also be cut with a cross
sectional shape of an ellipse. Instead of circles the laser is
scanned in elliptical shapes. For example an ellipse with the long
axis being vertical has the advantage of easier assuring a channel
connection to Schlemm's canal since it runs somewhere behind the
Trabecular Meshwork along the horizontal plane see FIG. 15.
[0114] Step j (optional) In step a. instead of placing the first
circle z-depth at +/-10 .mu.m within the top surface layer of the
tissue, the first cutting plane is adjusted 20 .mu.m below the
tissue surface. This thin tissue layer can still be sufficiently
penetrated by the laser energy and the resulting cavitation bubble
below the surface explodes the above tissue layers away more
effectively. This method variation requires a preferably 2 times
larger laser pulse energy setting and is therefore not available
for certain low cost, low power laser systems.
[0115] Step j. (optional) To create multiple holes and channels
step a. to step i. are repeated at a different locations.
[0116] Step k. (optional) (named as fourth method in parent
application) As a variation, using a low cost laser delivery system
that only contains a z-axis scan ability, the channel can be cut by
only performing step g, see FIG. 23. The amount of back and forward
scanning cycles is now increased to preferably 50 times+/-30
times.
[0117] Although the present invention has been described in
considerable detail with reference to the preferred versions
thereof, other versions are possible.
[0118] The scope of this patent and the appended claims is limited
to a "third method" as described above. The first and second
methods from the parent application are included since they are
referenced in the third method.
* * * * *