U.S. patent application number 13/366256 was filed with the patent office on 2012-09-06 for radiation-based dermatological devices and methods.
This patent application is currently assigned to TRIA Beauty, Inc.. Invention is credited to John P. Beale, Tobin C. Island, Harvey I-Heng Liu, Patrick Reichert.
Application Number | 20120226268 13/366256 |
Document ID | / |
Family ID | 45689029 |
Filed Date | 2012-09-06 |
United States Patent
Application |
20120226268 |
Kind Code |
A1 |
Liu; Harvey I-Heng ; et
al. |
September 6, 2012 |
Radiation-Based Dermatological Devices and Methods
Abstract
A self-contained, hand-held device for providing radiation-based
dermatological treatments includes a device body configured to be
handheld by a user; a laser supported in the device body, the laser
including a laser beam source configured to emit a laser beam; an
application end configured to be manually moved across the skin
during a treatment session; and electronics configured to control
the laser beam source to deliver the laser beam to the skin at a
delivered radiation intensity at the skin sufficient to provide an
effective dermatological treatment. The device may exclude any
optics downstream of the laser beam source, and may provide Class
1M or better eye safety classification per the IEC 60825-1 Class 1M
AEL (Accessible Emission Limit) specification
Inventors: |
Liu; Harvey I-Heng;
(Fremont, CA) ; Island; Tobin C.; (Oakland,
CA) ; Beale; John P.; (Mountain View, CA) ;
Reichert; Patrick; (Dublin, CA) |
Assignee: |
TRIA Beauty, Inc.
|
Family ID: |
45689029 |
Appl. No.: |
13/366256 |
Filed: |
February 3, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61439353 |
Feb 3, 2011 |
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61444079 |
Feb 17, 2011 |
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61469316 |
Mar 30, 2011 |
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61533641 |
Sep 12, 2011 |
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61533677 |
Sep 12, 2011 |
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61533786 |
Sep 12, 2011 |
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61545481 |
Oct 10, 2011 |
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61563491 |
Nov 23, 2011 |
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61594128 |
Feb 2, 2012 |
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Current U.S.
Class: |
606/9 |
Current CPC
Class: |
A61B 2090/065 20160201;
A61B 2018/00791 20130101; A61B 2018/00666 20130101; A61B 2090/061
20160201; A61B 2018/00458 20130101; A61B 2018/0047 20130101; A61B
2017/00769 20130101; A61B 2017/00154 20130101; A61N 2005/0644
20130101; A61N 5/0613 20130101; A61B 18/203 20130101; A61B
2018/00648 20130101; A61N 2005/067 20130101; A61B 2090/049
20160201; A61B 2018/00732 20130101; A61N 5/0616 20130101; A61B
2018/00476 20130101 |
Class at
Publication: |
606/9 |
International
Class: |
A61B 18/20 20060101
A61B018/20 |
Claims
1. A self-contained, hand-held device for providing laser-based
dermatological treatments, the device comprising: a device body
configured to be handheld by a user; a laser supported in the
device body, the laser including a laser beam source configured to
emit a laser beam; an application end configured to be manually
moved across the skin during a treatment session; electronics
configured to control the laser beam source to deliver the laser
beam to the skin at a delivered radiation intensity at the skin
sufficient to provide an effective dermatological treatment;
wherein the device includes no optics downstream of the laser beam
source; and wherein the laser beam emitted from the application end
of the device meets the Class 1M or better eye safety
classification per the IEC 60825-1.
2. The device of claim 1, wherein the delivered radiation intensity
at a treatment location on the skin is at least 1 J/cm2.
3. The device of claim 1, wherein the delivered radiation intensity
at a treatment location on the skin is at least 5 J/cm2.
4. The device of claim 1, wherein the delivered radiation intensity
at a treatment location on the skin is at least 10 J/cm2.
5. The device of claim 1, wherein: the laser beam source has an
emitter surface; and the emitter surface is arranged such that when
the application end is in contact with the skin, the emitter
surface is spaced from the skin surface by less than 10 mm.
6. The device of claim 1, wherein: the laser beam source has an
emitter surface; and the emitter surface is arranged such that when
the application end is in contact with the skin, the emitter
surface is spaced from the skin surface by less than 2 mm.
7. The device of claim 1, wherein the laser beam is divergent in at
least one direction upon incidence with the skin surface.
8. The device of claim 1, wherein the laser beam is divergent in at
least one direction by at least 25 degrees upon incidence with the
skin surface.
9. The device of claim 1, comprising electronics programmed to
pulse the laser during the treatment session such that the laser
beam source emits a sequence of pulsed laser beams to the skin to
generate an array of treatment spots on the skin, wherein adjacent
treatment spots generated on the skin are spaced apart from each
other by areas of non-treated skin between the adjacent treatment
spots.
10. The device of claim 1, comprising electronics programmed to:
determine a current setting for at least one first operational
parameter of the device; and based at least on the current setting
for the at least one first operational parameter, automatically
determine and affect an adjusted setting for at least one second
operational parameter of the device, such that based at least on
the current setting for the at least one first operational
parameter and the adjusted setting for at least one second
operational parameter, the emitted laser beam meets Class 1M or
better eye safety classification per the IEC 60825-1.
11. The device of claim 1, comprising electronics programmed to
automatically select or adjust at least one operational parameter
of the laser such that the emitted laser beam meets Class 1M or
better eye safety classification per the IEC 60825-1.
12. The device of claim 1, comprising electronics programmed to:
pulse the laser during the treatment session such that the laser
beam source emits a sequence of pulsed laser beams; and
automatically select or adjust at least a pulse duration of the
laser such that the radiation of the pulsed laser beams meets Class
1M or better eye safety classification per the IEC 60825-1.
13. The device of claim 1, comprising electronics programmed to:
pulse the laser during the treatment session such that the laser
beam source emits a sequence of pulsed laser beams; and
automatically select or adjust at least a pulse repetition
frequency of the laser such that the radiation of the pulsed laser
beams meets Class 1M or better eye safety classification per the
IEC 60825-1.
14. The device of claim 1, comprising electronics programmed to:
pulse the laser during the treatment session such that the laser
beam source emits a sequence of pulsed laser beams; and
automatically select or adjust at least a drive current supplied to
the laser such that the radiation of the pulsed laser beams meets
Class 1M or better eye safety classification per the IEC
60825-1.
15. The device of claim 1, comprising electronics programmed to:
pulse the laser during the treatment session such that the laser
beam source emits a sequence of pulsed laser beams; and
automatically select or adjust the total pulse energy delivered at
each location on the skin.
16. The device of claim 1, further comprising a control system
configured to prevent or reduce the likelihood of over-treatment of
a location on the skin.
17. The device of claim 1, comprising: electronics programmed to
pulse the laser during the treatment session such that the laser
beam source emits a sequence of pulsed laser beams to the skin to
generate treatment spots on the skin; and a control system
configured to prevent or reduce the likelihood of treatment spots
overlapping each other.
18. The device of claim 1, further comprising a control system
including: an eye safety sensors configured to generate signals;
and electronics configured to control at least one operational
parameter of the laser based on the signals from the eye-safety
sensor.
19. A self-contained, hand-held device for providing laser-based
dermatological treatments, the device comprising: a device body
configured to be handheld by a user; a laser supported in the
device body, the laser including a laser beam source configured to
emit a laser beam; an application end configured to be manually
moved across the skin during a treatment session; electronics
configured to pulse the laser during the treatment session such
that the laser beam source emits a sequence of pulsed laser beams;
and wherein each pulsed laser beam has the same, fixed propagation
path with respect to the device body; and wherein the radiation of
the pulsed laser beams emitted from the application end of the
device meets the Class 1M or better eye safety classification per
the IEC 60825-1.
20. A self-contained, hand-held device for providing a laser-based
fractional treatment in the skin, the device comprising: a device
body configured to be handheld by a user; a laser supported in the
device body, the laser including a laser beam source configured to
emit a laser beam; an application end configured to be manually
moved across the skin during a treatment session; electronics
programmed to pulse the laser during the treatment session such
that the laser beam source emits a sequence of pulsed laser beams
to the skin to generate an array of treatment spots on the skin,
wherein adjacent treatment spots generated on the skin are spaced
apart from each other by areas of non-treated skin between the
adjacent treatment spots; wherein the device includes no optics
downstream of the laser beam source; and wherein the radiation of
the pulsed laser beams emitted from the application end of the
device meets the Class 1M or better eye safety classification per
the IEC 60825-1.
21. A self-contained, hand-held device for providing laser-based
dermatological treatments, the device comprising: a device body
configured to be handheld by a user; a laser supported in the
device body, the laser including a laser beam source configured to
emit a laser beam; an application end configured to be manually
moved across the skin during a treatment session; electronics
configured to control the laser beam source to deliver the laser
beam to the skin at a delivered radiation intensity at the skin
sufficient to provide an effective dermatological treatment;
wherein the device includes no optics downstream of the laser beam
source; and wherein the laser beam emitted from the application end
of the device falls outside the IEC 60825-1 Class 1M eye safety
classification by less than 50% of the difference to the next lower
IEC 60825-1 classification threshold.
22. The device of claim 21, wherein the laser beam emitted from the
application end of the device falls outside the IEC 60825-1 Class
1M eye safety classification by less than 25% of the difference to
the next lower IEC 60825-1 classification threshold.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/439,353 filed on Feb. 3, 2011; U.S. Provisional
Application No. 61/444,079 filed on Feb. 17, 2011; U.S. Provisional
Application No. 61/469,316 filed on Mar. 30, 2011; U.S. Provisional
Application No. 61/533,641 filed on Sep. 12, 2011; U.S. Provisional
Application No. 61/533,677 filed on Sep. 12, 2011; U.S. Provisional
Application No. 61/533,786 filed on Sep. 12, 2011; U.S. Provisional
Application No. 61/545,481 filed on Oct. 10, 2011; U.S. Provisional
Application No. 61/563,491 filed on Nov. 23, 2011; and U.S.
Provisional Application No. 61/594,128 filed on Feb. 2, 2012; all
of which applications are herein incorporated by reference in their
entirety.
TECHNICAL FIELD
[0002] The present disclosure is related to radiation-based
dermatological treatment devices and methods, e.g., laser-based
devices for providing fractional treatment, or devices using any
other type of radiation source for providing any other suitable
type of dermatological treatment.
BACKGROUND
[0003] Light-based treatment of tissue is used for a variety of
applications, such as hair removal, skin rejuvenation, wrinkle
treatment, acne treatment, treatment of vascular lesions (e.g.,
spider veins, diffuse redness, etc.), treatment of cellulite,
treatment of pigmented legions (e.g., age spots, sun spots, moles,
etc.), tattoo removal, and various other treatments. Such
treatments generally include delivering light or laser radiation to
an area of tissue on a person's body, e.g., the skin or internal
tissue, to treat the tissue in a photochemical, photobiological,
thermal, or other manner, which can be ablative or non-ablative,
among other properties, depending on the particular
application.
[0004] Light-based treatment devices include various types of light
sources, such as lasers, LEDs, flashlamps, etc. For example, diode
lasers are particularly suitable for certain light-based treatments
and devices for providing such treatments. Diode lasers are
compact, as they are typically built on one chip that contains the
major necessary components for light generation other than a power
source. Further, diode lasers typically provide an efficiency of up
to 50% or higher, which enables them to be driven by low electrical
power compared to certain other lasers. Diode lasers allow direct
excitation with small electric currents, such that conventional
transistor based circuits can be used to power the laser.
[0005] Other characteristics typical of diode lasers include high
temperature sensitivity/tunability, and a highly divergent beam
compared to certain other lasers. Diode lasers typically emit a
beam having an axis-asymmetric profile in a plane transverse to the
optical axis of the laser. In particular, the emitted beam diverges
significantly faster in a first axis (referred to as the "fast
axis") than in an orthogonal second axis (referred to as the "slow
axis"). In contrast, other types of lasers, e.g., fiber lasers,
typically emit a beam having an axis-symmetric profile in the
transverse plane.
[0006] Laser-based treatment devices typically include optics
downstream of the laser source to scan, shape, condition, direct,
and/or otherwise influence the laser radiation to the target tissue
as desired. Such optics may include lenses, mirrors, and other
reflective and/or transmissive elements, for controlling optical
parameters of the beam, such as the direction, propagation
properties or shape (e.g., convergent, divergent, collimated), spot
size, angular distribution, temporal and spatial coherence, and/or
intensity profile of the beam, for example. Some devices include
systems for scanning a laser beam in order to create a pattern of
radiated areas (e.g., spots, lines, or other shapes) in the tissue.
For some applications, the scanned pattern of radiated areas
overlap each other, or substantially abut each other, or are
continuous, in order to provide complete coverage of a target area
of tissue. For other applications, e.g., certain wrinkle
treatments, vascular treatments, pigmentation treatments,
anti-inflammatory treatments, and other skin rejuvenation
treatments, the scanned radiated areas may be spaced apart from
each other by non-irradiated areas such that only a fraction of the
overall target area of the tissue is radiated during a treatment
session. Thus, in such applications, there are generally regions of
untreated tissue between regions of treated tissue. This type of
treatment is known as "fractional" treatment (or more specifically,
fractional photothermolysis in some cases) because only a fraction
of the target area is irradiated during a treatment session.
SUMMARY
[0007] The present disclosure is related to radiation-based
dermatological treatment devices and methods, e.g., laser-based
devices for providing fractional treatment.
[0008] In some embodiments, a hand-held compact device is provided
for providing radiation-based dermatological treatments, e.g., skin
resurfacing, skin rejuvenation, wrinkle treatment, removal or
reduction of pigmentation, hair removal, acne treatment, skin
tightening, redness, vascular treatments such as telangectasia or
port-wine stains, stretch marks, anti-aging, or anti-inflammatory
skin treatments such as treating rosacea, acne, or vitiligo. Other
embodiments may apply to non-skin tissue treatment, such as eye
tissue or internal organs. In particular embodiments, the device is
a compact-hand-held device for providing laser-based non-ablative
fractional treatment by pulsing one or more laser beam sources as
the device is moved, or "manually scanned," across the skin,
wherein the device omits any optics (e.g., mirrors, powered lenses,
etc.) for influencing the laser beams, and wherein the laser beam
source(s) along with the laser beam(s) emitted by the laser beam
source(s) are attached in a fixed manner (in location and
direction) and remain fixed (in location and direction) with
respect to the device housing during operation of the device.
[0009] The device may include one or more radiation sources that
radiate energy to the skin in the form of one or more beams to
produce one or more irradiated areas on the skin that provide a
dermatological treatment. As used herein, "radiation" may include
any radiative energy, including electromagnetic radiation, UV,
visible, and IP light, radio frequency, ultrasound, microwave, etc.
A radiation source may include any suitable device for radiating
one or more coherent or incoherent energy beams, e.g., a laser,
LED, flashlamp, ultrasound device, RF device, microwave emitter,
etc. Energy beams may be provided in any suitable manner, such as
pulsed, continuous wave (CW), or otherwise, depending on the
particular embodiment, application, or device setting. In some
embodiments, the radiation source is a laser, e.g., an edge
emitting laser diode, laser diode bar, HeNe laser, YAG laser, VCSEL
laser, or other types of laser, that delivers one or more laser
beams to the skin to effect a treatment. It should be understood
that references herein to a radiation source or an energy beam in
the singular should be interpreted to mean at least one radiation
source or at least one energy beam, unless otherwise specified,
e.g., references to a single radiation source or a single energy
beam, or references to radiation sources or energy beams (or
references to multiple radiation sources or multiple energy
beams).
[0010] In some embodiments, the device provides pulsed energy beams
to the skin to provide a fractional dermatological treatment, e.g.,
skin resurfacing, skin rejuvenation, wrinkle treatment, removal or
reduction of pigmentation, treatment of coarse skin caused by
photodamage, etc. Each pulsed energy beam forms an irradiated
treatment spot (or "treatment spot") on the surface of the skin,
and a three-dimensional volume of thermally damaged (or otherwise
influenced, such as photochemically) skin extending below the
surface of the skin, referred to herein as a micro thermal zone
(MTZ). Each MTZ may extend from the skin surface downward into the
skin, or may begin at some depth below the skin surface and extend
further downward into the skin, depending on the embodiment, device
settings, or particular application. The device may be configured
to generate an array of MTZs in the skin that are laterally spaced
apart from each other by volumes of untreated (i.e., non-irradiated
or less irradiated) skin. For example, an application end of the
device (also referred to herein as the device "tip") may be
manually moved (e.g., in a sliding manner) across the surface of
the skin during a treatment session. An energy beam or beams may be
pulsed (to generate MTZs in the skin) during the movement of the
device across the skin (referred to herein as a "gliding mode"
treatment), or between movements of the device across the skin
(referred to herein as a "stamping mode" treatment), or a
combination of these modes or different modes. The skin's healing
response, promoted by the areas of untreated (i.e., non-irradiated)
skin between adjacent MTZs, provides fractional treatment benefits
in the treatment area (e.g., skin resurfacing or rejuvenation,
wrinkle removal or reduction, pigment removal or reduction, etc.).
In some embodiments or applications, the compact, hand-held device
may yield results similar to professional devices, but leverages a
home use model to more gradually deliver the equivalent of a single
professional dose over multiple treatments or days (e.g., a 30 day
treatment routine or a two treatment sessions per week treatment
routine). Skin rejuvenation generally includes at least one or more
of treatments for wrinkles, dyschromia, pigmented lesions, actinic
kerotosis, melasma, skin texture, redness or erythema, skin
tightening, skin laxity, and other treatments.
[0011] As used herein, "fractional" treatment means treatment in
which individual treatment spots generated on the skin surface are
physically separated from each other by areas of non-irradiated (or
less irradiated) skin (such that the MTZs corresponding to such
treatment spots are generally physically separated from each
other). In other words, in a fractional treatment, adjacent
treatment spots (and thus their corresponding MTZs) do not touch or
overlap each other. In some embodiments in which a radiation source
(e.g., laser) is pulsed to generate a successive series of
treatment spots on the skin, the pulse rate may be set or selected
based on a typical or expected speed at which the device is
manually moved or "glided" across the skin, referred to herein as
the "manual glide speed" (e.g., in a gliding mode operation of the
device). In particular, the pulse rate may be set or selected such
that for a range of typical or expected manual (or
mechanically-driven) glide speeds, adjacent treatment spots are
generally physically separated from each other by areas of
non-treated skin (i.e., fractional treatment is provided). In some
embodiments, the pulse rate may be set or selected such that for a
range of typical or expected manual glide speeds, adjacent
treatment spots are physically separated from each other from a
predetermined minimum non-zero distance, e.g., 500 .mu.m. For
example, in some embodiment, a pulse rate of between 2 and 30 HZ
(e.g., about 15 Hz) may be selected for providing a desired
fractional treatment for typical or expected manual glide speeds of
between 1 and 6 cm/sec.
[0012] In some embodiments, the device may be controlled to
prevent, limit, or reduce the incidence or likelihood of treatment
spot overlap, e.g., based on feedback from one or more sensors
(e.g., one or more dwell sensors, motion/speed sensors, and/or
displacement sensors). For example, the device may monitor the
speed or displacement of the device relative to the skin and
control the radiation source accordingly, e.g., by turning off the
radiation source, reducing the pulse rate, etc. upon detecting that
the device has not been displaced on the skin a minimum threshold
distance from a prior treatment location. Further, in some
embodiments, the pulse rate may be automatically adjustable by the
device and/or manually adjustable by the user, e.g., to accommodate
different manual glide speeds and/or different comfort levels or
pain tolerance levels of the user.
[0013] In some embodiments, the device may be configured to provide
3D fractional treatment, by generating MTZs at various depths in
the skin. For example, this may be achieved by providing a
plurality of beam sources configured to generate MTZs at different
depths, e.g., by using multiple beam sources arranged at different
distances from the skin surface, focal depths, wavelengths, pulse
energies, pulse durations, or other parameters. Thus, such
embodiments may have a solid-state configuration in which the beam
sources and the beams propagated from the beam sources remain fixed
with respect to the device housing (i.e., no moving parts regarding
the beam delivery). As another example, such 3D fractional
treatment can be achieved by dynamically moving or adjusting one or
more beam sources or output beams, or dynamically adjusting the
focal points of one or more beams.
[0014] In some embodiments, the device includes a
displacement-based control system including a displacement sensor
and electronics configured to measure or estimate the lateral
displacement of the device across the skin and control one or more
aspect of the device (e.g., on/off status or pulse rate of the
radiation source) based on the determined displacement of the
device. For example, the displacement-based control system may
control the delivery of energy beams to provide a desired spacing
between treatment spots (for a fractional treatment) and/or to
prevent or reduce the incidence or likelihood of treatment spot
overlap.
[0015] In some embodiments, pulsed energy beams are manually
scanned across the skin, rather than using an automated scanning
system (e.g., including systems for moving optical elements and/or
the laser or other energy source) present in various existing
devices. In some embodiments the device does not include any moving
optics (or any optics at all, as discussed below). In some
embodiments, both the radiation source and energy beam path from
the radiation source to the skin are fixed with respect to the
outer housing of the device. Omitting an automated scanning system
from the device may permit a smaller beam output window or
aperture, in particular for embodiment that include only a single
beam source, as the emitted energy beam remains fixed relative to
the device housing. For example, certain embodiments may include a
beam output window or aperture having a maximum width or diameter
of less than 1 mm (and in particular embodiments, less than 0.5
mm), as a beam emitted by certain laser sources (e.g., an edge
emitting laser diode) typically has a very small diameter (e.g.,
about 120 microns) and may be fixed such that the beam remains
centered in the exit window/aperture. In comparison, certain
automated-scanner-based devices have an output window or aperture
of greater than one square centimeter in area.
[0016] In some embodiments, the device includes a single radiation
source, e.g., an edge emitting laser diode, a VCSEL having a single
micro-emitter zone, an LED, or a flashlamp. For certain treatments,
the single radiation source may be pulsed while the device is
glided across the skin to form a generally one-dimensional array
(or line) of treatment spots on the skin. A two-dimensional array
of treatment spots can thus be created by gliding the device across
the skin multiple times in any suitable pattern.
[0017] In other embodiments, the device includes multiple radiation
sources, e.g., multiple edge emitting laser diodes, an laser diode
bar having multiple emitters (or multiple laser diode bars), a
VCSEL having multiple micro-emitter zones (or multiple VCSELs), or
multiple LEDs. For certain treatments, the multiple radiation
sources may be pulsed while the device is operated in a gliding
mode or alternatively in a stamping mode or a combination of modes,
to form a two-dimensional array of treatment spots on the skin on
each glide. Such device may be glided across the skin multiple
times to create a larger, more dense, or otherwise different
two-dimensional array.
[0018] Further, the device may be configured for "direct exposure"
or "indirect exposure" radiation, and/or for "close proximity" or
"remote proximity" radiation, depending on the particular
embodiment and/or configuration of the device. "Direct exposure"
embodiments or configurations do not include any optics downstream
of the radiation source for affecting or treating the beam(s)
generated by the radiation source(s) (the term "optics" is defined
below in this document). Some direct exposure devices may include a
window (e.g., to protect the radiation source and/or other internal
components of the device) that does not substantially affect the
beam. A window may be formed from any suitable material, e.g.,
sapphire, quartz, diamond, or other material transparent at the
frequency of the radiation source 14 and preferably also having a
good thermal coefficient.
[0019] Thus, embodiments of the device may create a desired array
of MTZs without using microlenses or other similar optics. Thus,
embodiments of the device may provide increased optical efficiency,
reduced power requirements, simpler and less expensive
manufacturing, increased compactness, and/or enhanced reliability
as compared with certain non-ablative fractional treatment devices
that use microlenses or other similar optics for creating MTZ
arrays. However, it should be understood that certain embodiments
of the device may include one or more optics, e.g., for desired
beam shaping.
[0020] The omission of beam-influencing optics in certain
embodiments may result in an overall higher optical efficiency for
the device. In any optical system, losses occur due to less than
perfect transmission, reflection, or beam "spilling" outside of the
diameter of the optical element(s) in the beam path. Thus,
embodiments of the device that omit beam-influencing optics may
provide increased optical efficiency, and thus allow reduced power
to the radiation source(s), as compared with certain conventional
devices.
[0021] In contrast, "indirect exposure" embodiments or
configurations include one or more optics downstream of the
radiation source(s) for affecting or treating the beam(s) generated
by the radiation source(s). Optics may allow the radiation
source(s) to be positioned at any desired distance from the
application end of the device that contacts the skin during
treatment (and thus at any desired distance from the target
surface) or to affect other radiation properties. Certain
embodiments that use a laser diode as the radiation source may
include one or more fast axis optical elements for capturing and
focusing the rapidly diverging fast axis beam profile emitted from
the laser diode or, a scanner, such as a rotating optic or a
microlens array, for suitably delivering/distributing the
radiation.
[0022] In "close proximity" embodiments or configurations, the
emitting surface of each radiation source (e.g., the emitting
surface of an edge emitting laser diode) is positioned within 10 mm
of the skin-contacting surface of the device (i.e., the leading
surface of the device tip), such that the emitting surface of each
radiation source is positioned within 10 mm of the skin surface
when the device tip is positioned in contact with the skin. As
discussed below, this distance is referred to herein as the
"proximity gap spacing." In contrast, in "remote proximity"
embodiments or configurations, the proximity gap spacing (between
the emitting surface of the radiation source(s) and the
skin-contacting surface of the device) is greater than 10 mm. Some
close proximity embodiments, due to the small proximity gap spacing
and thus short travel distance of the beam(s) from the radiation
source(s) to the skin, may omit precision-aligned optics (or all
optics) that may be needed in similar remote proximity embodiments,
thus providing a direct exposure, close proximity configuration.
Some particular embodiments discussed below include an edge
emitting laser diode configured for direct exposure and close
proximity radiation, wherein the emitting surface of the edge
emitting laser diode is positioned within 10 mm of the skin
surface, with no optics (e.g., only a window, open space,
protective coating, or similar feature) between the edge emitting
laser diode and the skin. Direct exposure, close proximity
embodiments may be particularly compact. Some direct exposure,
close proximity embodiments may provide a high optical throughput
and may be capable of generating relatively high-power emissions in
a compact battery-operated device.
[0023] It should be understood that "direct exposure" is not
synonymous with "close proximity," and likewise "indirect exposure"
is not synonymous with "remote proximity." That is, direct exposure
embodiments or configurations may be configured for either close
proximity or remote proximity radiation, depending on the
particular embodiment or configuration. For example, collimated or
quasi-collimated light sources could be located with remote
proximity and be direct exposure in that the beam has no optics
between the source and the skin. Similarly, indirect exposure
embodiments or configurations may be configured for either close
proximity or remote proximity radiation, depending on the
particular embodiment or configuration. For example, some
embodiments may include a very small lens (e.g., a cylindrical or
ball lens) downstream of the light source, but wherein the emitting
surface of each radiation source is still within 10 mm of the skin
surface during treatment.
[0024] In some embodiments, the beam generation and delivery
components of the device have an all-solid-state construction that
excludes any automated or mechanically moving parts for dynamically
moving the beam source and direction and location of the propagated
beam relative to the device housing, including (a) any motorized or
otherwise moving beam-scanning elements, such as motorized or
otherwise moving optical elements to scan a beam to multiple
different directions or locations relative to the device housing
(e.g., galvo-controlled mirrors or rotating multi-faceted scanning
elements), and (b) any motorized or other elements for physically
moving the beam source and any associated beam delivery elements
(e.g., a laser, LED, fiber, waveguide, etc.). Such embodiments may
reduces noise, increase the reliability of the device, reduce
manufacturing cost and complexity, and/or increase compactness of
the finished device with low or minimal component count.
[0025] In some embodiments, the device has an all-solid-state
construction with no automated moving parts at all, including no
any automated or mechanically moving parts for dynamically moving
the beam source and direction and location of the propagated beam
relative to the device housing (as discussed above), as well as any
fans, other motors, or other automated moving parts.
[0026] Certain example embodiments are handheld, battery powered,
compact skin treatment devices with all solid-state components,
configured to provide direct exposure, close-proximity radiation,
and for providing skin area coverage via manual scanning of the
device across the surface of the skin, in a gliding or stamping
mode operation, and using a CW or pulsed radiation source (or
multiple CW or pulsed radiation sources).
[0027] In some embodiments, the device is fully or substantially
self-contained in a compact, hand-held housing. For example, in
some battery-powered embodiments of the device, the radiation
source(s), user interface(s), control electronics, sensor(s),
battery or batteries, fan(s) or other cooling system (if any),
and/or any optics (if any), are all contained in a compact,
hand-held housing. Similarly, in some wall-outlet-powered
embodiments of the device, the radiation source(s), user
interface(s), control electronics, sensor(s), battery or batteries,
fan(s) or other cooling system (if any), and/or any optics (if
any), are all contained in a compact, hand-held housing, with only
the power cord extending from the device.
[0028] In other embodiments, one or more main components of the
device may be separate from the device housing, and connected by
any suitable physical or wireless means (e.g., wire, cable, fiber,
wireless communications link, etc.)
[0029] In some embodiments, the device provides eye safe radiation,
e.g., by delivering a substantially divergent energy beam (e.g.,
using an edge emitting laser diode with no downstream optics),
and/or using an eye safety control system including one or more
sensors, and/or by any other suitable manner. In some laser-based
embodiments or settings, the device meets the Class 1M or better
(such as Class 1) eye safety classification per the IEC 60825-1. In
other laser-based embodiments or settings, the device falls outside
the IEC 60825-1 Class 1M eye safety classification by less than 25%
of the difference to the next classification threshold. In still
other laser-based embodiments or settings, the device falls outside
the IEC 60825-1 Class 1M eye safety classification by less than 50%
of the difference to the next classification threshold. In some
lamp-based embodiments, the device meets the "Exempt" or "Low Risk"
eye safety classification per the IEC 62471.
[0030] In some embodiments, the device uses one or more VCSEL
(Vertical Cavity Surface Emitting Laser) lasers as the radiation
source(s). A VCSEL may be configured to generate a single energy
beam or multiple discrete energy beams. For the latter, the VCSEL
may include non-active regions that define an array of
micro-emitter zones separated from each other by non-active (or
less active or masked) regions, with each micro-emitter zone
generating a beam, such that a single VCSEL may generate an array
(e.g., a 1D or 2D array) of laser beams. In some embodiments, the
array of laser beams is delivered to the skin to provide an array
of spaced-apart treatment spots on the skin, and thus an array of
spaced-apart MTZs, e.g., to provide a fractional treatment via a
manual gliding mode or stamping mode operation of the device. In
some embodiments, the beam generated from each micro-emitter zone
is substantially axially-symmetric (e.g., as opposed to the beam
generated by an edge emitting laser diode). In some embodiments, a
two-dimensional multi-zone pulsed VCSEL may be configured in direct
exposure, close proximity (in effect, placed directly or nearly
directly against the skin) to affect a fractional treatment when
glided or stamped across the skin. Likewise, a one-dimensional,
multi-zone pulsed VCSEL can be configured in direct exposure, close
proximity to affect a fractional treatment when glided or stamped
across the skin.
[0031] In some embodiments, the device is eye safe, hand held,
manufacturable without excessive labor costs, requires low power
consumption, and effective. In some embodiments, the device
eliminates the need for optical scanners, microlenses, or other
complex optical and mechanical devices, for creating multiple MTZs
in the skin. In particular embodiments, the device is battery
powered, with a single, fixed location, repetitively-pulsed edge
emitting laser diode for creating an array of MTZs in the skin by
manually scanning the device across the skin while the edge
emitting laser diode is repetitively pulsed, with each pulse
creating a single MTZ in the skin. In other embodiments, multiple
beam sources (e.g., multiple edge emitting laser diodes, certain
laser diode bars, certain VCSEL configurations) multiple can be
used to create multiple MTZs in the skin for each pulse of the
multiple beam sources.
[0032] In some embodiments, the device may be suitable for
providing a fractional treatment using a home-use treatment plan
that includes treatment sessions of a few minutes or less, once or
twice a day. In some embodiments, a treatment session of two
minutes, for example, may allow an effective treatment of about
20-30 cm.sup.2 (about 4 in.sup.2). Further, certain embodiments
permits the use a small battery, and allow for thermal control
without any fan(s). For example, in some embodiments, a small
cylindrical block of copper can absorb the waste heat from a laser
during a treatment session, preventing excessive temperature rise
of the diode without the use of a fan. Other embodiments may
include at least one fan for increased cooling of the device
components.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Some embodiments of the disclosure may be understood by
referring, in part, to the following description and the
accompanying drawings wherein:
[0034] FIG. 1 illustrates components of an example radiation-based
treatment device, according to certain embodiments.
[0035] FIG. 2 illustrates an example control system for a
radiation-based treatment device, according to example
embodiments.
[0036] FIG. 3 illustrates a schematic layout of various components
of a radiation-based treatment device, according to example
embodiments.
[0037] FIG. 4 illustrates an example radiation-based treatment
device configured as a direct exposure device for providing
fractional treatment, according to certain embodiments of the
present disclosure.
[0038] FIGS. 5A and 5B illustrate a 3-D side view and an end tip
view, respectively, of an example radiation engine for use in the
direct exposure laser treatment device shown in FIG. 4, according
to an example embodiment.
[0039] FIG. 6 illustrates an exploded view of the example laser
treatment device shown in FIG. 5.
[0040] FIG. 7 illustrates an example electrical schematic of laser
pulsing electronics for controlling the pulsing of the edge
emitting laser diode of the example direct exposure laser treatment
device shown in FIGS. 5-7.
[0041] FIGS. 8A-8J illustrates example patterns of treatment spots
and example glide directions and patterns for use with the device
of the present disclosure, according to certain embodiments.
[0042] FIG. 9 shows a three-dimensional cross-section of a volume
of skin for illustrating the process of a non-ablative fractional
treatment.
[0043] FIG. 10 illustrates a simplified cross-sectional side view
of an example direct exposure embodiment that includes an edge
emitting laser diode and a window in contact with the skin.
[0044] FIG. 11 illustrates a simplified cross-sectional side view
of an example direct exposure embodiment that includes an edge
emitting laser diode and a window offset from the skin.
[0045] FIG. 12 illustrates a simplified cross-sectional side view
of an example direct exposure embodiment that includes an edge
emitting laser diode separated from the skin by only an air
gap.
[0046] FIG. 13 illustrates a simplified cross-sectional side view
of an example direct exposure embodiment that includes an edge
emitting laser diode having a covering film and separated from the
skin by only an air gap.
[0047] FIG. 14 illustrates a simplified cross-sectional side view
of an example direct exposure embodiment that includes multiple
edge emitting laser diodes and a window in contact with the
skin.
[0048] FIG. 15 illustrates a simplified cross-sectional side view
of an example indirect exposure embodiment that includes an edge
emitting laser diode and a downstream concave lens.
[0049] FIG. 16 illustrates a simplified cross-sectional side view
of an example indirect exposure embodiment that includes an edge
emitting laser diode and a downstream ball lens.
[0050] FIGS. 17A-17C illustrate the asymmetrical divergence of a
beam emitted from an edge emitting laser diode, in embodiments in
which the proximity gap spacing is extremely small.
[0051] FIGS. 18A-18C illustrate the asymmetrical divergence of a
beam emitted from an edge emitting laser diode, in embodiments with
a larger proximity gap spacing.
[0052] FIG. 19A-19B illustrates smearing or blurring of a treatment
spot due to movement of the device across the skin during the
treatment pulse.
[0053] FIG. 20 is a plot of a detected wavelength profile of laser
radiation received at a target surface from an example edge
emitting laser diode.
[0054] FIGS. 21A and 21B illustrate example dimensions for a
treatment spot and corresponding MTZ generated by an edge emitting
laser diode configured for direct exposure and/or close proximity
radiation, according certain embodiments.
[0055] FIGS. 22A and 22B illustrate a configuration and example
treatment spot array, respectively, for a device including a laser
diode bar as the radiation source, according to certain
embodiments.
[0056] FIGS. 23A and 23B illustrate a configuration and example
treatment spot array, respectively, for a device including multiple
laser diode bars as the radiation source, according to certain
embodiments.
[0057] FIGS. 24A and 24B illustrate a configuration and example
treatment spot, respectively, for a device including a high
fill-factor laser diode bar as the radiation source, according to
certain embodiments.
[0058] FIGS. 25 and 26 illustrate components of an example
embodiment of a device in which the radiation source is laser diode
bar including an array of 19 laser emitters that emit an array of
beams to generate an array of treatment spots in each pulse.
[0059] FIG. 27 illustrates an example direct exposure configuration
of a device including a single-beam-source VCSEL laser as the
radiation source, according to certain embodiments.
[0060] FIG. 28 illustrates an example arrangement of micro-emitters
forming a single-beam-source VCSEL laser, according to an example
embodiment.
[0061] FIG. 29 illustrates an example indirect exposure arrangement
of a single-beam-source VCSEL laser and downstream optic (concave
lens), according to certain embodiments.
[0062] FIG. 30 illustrates an example arrangement of micro-emitters
and non-active areas forming a multiple-beam-source VCSEL laser,
according to an example embodiment.
[0063] FIG. 31 illustrates an example direct exposure configuration
of a device including a multiple-beam-source VCSEL laser as the
radiation source, according to certain embodiments.
[0064] FIG. 32 illustrates an example treatment spot array produced
by an example multiple-beam-source VCSEL laser having a
two-dimensional array of emitter zones, according to certain
embodiments.
[0065] FIG. 33 illustrates an example treatment spot array produced
by an example multiple-beam-source VCSEL laser having a
one-dimensional array of emitter zones, according to certain
embodiments.
[0066] FIG. 34 illustrates an example indirect exposure arrangement
of a multiple-beam-source VCSEL laser and downstream optic concave
lens array), according to certain embodiments.
[0067] FIG. 35 illustrates a block diagram of an example
displacement-based control system, according to certain
embodiments.
[0068] FIG. 36 illustrates a flowchart of an example method for
controlling a device using a displacement-based control system,
while the device is used either in a gliding mode or a stamping
mode, according to certain embodiments.
[0069] FIG. 37 illustrates an example single-pixel displacement
sensor for use in a displacement-based control system, according to
certain embodiments.
[0070] FIG. 38 illustrates another example single-pixel
displacement sensor for use in a displacement-based control system,
according to certain embodiments.
[0071] FIG. 39 illustrates yet another example single-pixel
displacement sensor for use in a displacement-based control system,
according to certain embodiments.
[0072] FIG. 40 illustrates a pair of experimental data plots for an
embodiment of an optical displacement sensor being scanned above
the skin surface of a human hand.
[0073] FIG. 41 represents an example plot of a signal generated by
a detector as a displacement sensor is moved across the skin of a
human hand.
[0074] FIG. 42 illustrates three data plots: a raw signal plot,
filtered signal plot, and a intrinsic skin feature detection plot,
for detecting skin features based on signals from a displacement
sensor, according to certain embodiments.
[0075] FIG. 43 illustrates a more specific example of the general
method of FIG. 36 for controlling a device using a
displacement-based control system, according to certain
embodiments.
[0076] FIG. 44 illustrates an example multi-pixel imaging
correlation sensor, of the type used in optical mice for computer
input, for detecting displacement along the skin, according to
certain embodiments.
[0077] FIG. 45 illustrates an example method for controlling device
using a displacement-based control system that employs a
multi-pixel displacement sensor, while device is used either in a
gliding mode or a stamping mode, according to certain
embodiments.
[0078] FIGS. 46A-46G illustrate example embodiments of a
roller-based sensor that may be used a displacement sensor, or a
motion/speed sensor, or both, for use in certain embodiments.
[0079] FIG. 47 illustrates an example method for executing a
treatment session for providing treatment (e.g., fractional light
treatment) to a user with certain embodiments of the device.
[0080] FIGS. 48-49 illustrate an example optical eye safety sensor,
according to certain embodiments.
[0081] FIGS. 50A and 50B illustrate the local surface normal
directions for example corneas of different shapes.
[0082] FIG. 51 illustrates an example multi-sensor control system
that includes one or more eye safety sensors and one or more skin
contact sensors arranged on or near device application end,
according to certain embodiments.
[0083] FIG. 52 illustrates an example method for controlling a
device using a multi-sensor control/safety system, according to
certain embodiments.
[0084] FIG. 53 illustrates an example method for calibrating an eye
safety sensor for one or multiple users, according to certain
embodiments.
[0085] FIG. 54 shows another embodiment of a radiation-based
treatment device.
[0086] FIG. 55 illustrates an example operational schematic of the
example device shown in FIG. 54, according to certain
embodiments.
DETAILED DESCRIPTION OF THE DRAWINGS
[0087] Some embodiments of the disclosure may be understood by
referring, in part, to the following description and the
accompanying drawings, in which like reference numbers refer to the
same or like parts.
[0088] FIG. 1 illustrates various components of an example
held-held radiation-based treatment device 10, according to certain
embodiments. Radiation-based treatment device 10 may include a
radiation engine 12 including a radiation source 14 configured to
generate an energy beam 60, optics 16 for conditioning and/or
delivering the energy beam 60 to a treatment area of skin 40,
control systems 18, one or more power supplies 20, and/or one or
more fans 34.
[0089] As discussed above, "direct exposure" embodiments of device
10 may omit optics 16 such that no significant optics are provided
between radiation source 14 and the skin surface, thus providing
direct radiation of the skin. Further, as discussed above, in some
direct exposure embodiments, the emitting surface of radiation
source 14 is located in close proximity (within 10 mm) of the
skin-contacting surface of the treatment tip of the device or
target tissue 40.
[0090] In some embodiments, the main components of device 10 may be
substantially self-contained in a held-held structure or outer
housing 24. Held-held housing 24 may define an application end (or
"treatment tip") 42 configured to be placed in contact with the
skin (or other target surface) during treatment of a treatment area
of skin 40. Application end 42 may include or house various user
interfaces, including the treatment delivery interface for
delivering energy beam 60 to the user, as well as one or more
sensors 26 for detecting various characteristics of the skin (or
other surface) and/or energy delivered by device 10. In some
embodiments, application end 42 may include an aperture or window
44 through which the laser beam is delivered to the target surface,
or alternatively, an optical element 16 (e.g., a lens) may be
located at application end 42 and configured for direct contact or
close proximity with the skin during treatment.
[0091] Device 10 may include any other components suitable for
providing any of the functionality discussed herein or other
related functionality known to one of ordinary skill in the
art.
[0092] Radiation engine 12 may include one or more radiation
sources 14, such as one or more lasers, LEDs, and/or flashlamps,
ultrasound devices, RF devices, or microwave emitters, for example.
Embodiments including lasers as the radiation source 14 may include
any type or types of lasers, e.g., one or more edge emitting laser
diodes (single emitter edge emitting laser diodes or multiple
emitter edge emitting laser diodes), laser diode bars, VCSEL lasers
(Vertical Cavity Surface Emitting Lasers), CO2 lasers, Erbium YAG
lasers, pulsed dye lasers, fiber lasers, other types of lasers, or
any combination thereof.
[0093] Radiation source 14 may include one or more beam source,
each operable to generating a beam for delivery to the skin. In
some embodiments, radiation source 14 is a laser having exactly one
beam source for generating a single beam, for example (a) a
single-emitter edge emitting laser diode that generates a single
beam, (b) a multi-emitter edge emitting laser diode that generates
a single collective beam, e.g., as described in co-pending U.S.
Provisional Patent Application 61/594,128, the entire contents of
which are hereby incorporated by reference, (c) a laser diode bar
with high fill factor to generate a single collective beam or
single beam with spatial modulation of its energy profile, e.g., as
discussed below, or (d) a VCSEL laser having multiple emitters that
together act as a single beam source (i.e., a single "micro-emitter
zone") to generate a single combined beam. Item (b) "a
multi-emitter edge emitting laser diode that generates a single
collective beam" refers to an integral or monolithic laser diode
structure having multiple emitter junctions formed on a substrate
(such as, for example, a "multiple quantum well" (MQW) laser
diode), and is thus distinguished from a laser diode bar.
[0094] In other embodiments, radiation source 14 is a laser having
multiple beam sources for generating multiple discrete beams, for
example (a) an laser diode bar having multiple emitters, each
generating a single discrete beam, or (b) a VCSEL laser having
multiple micro-emitter zones (with one or more emitter per zone),
with each micro-emitter zone acting as a discrete beam source to
generate a single beam discrete from the others. Such multiple beam
sources may be arranged in a row, a two-dimensional array, or
otherwise.
[0095] In some embodiments, the beam emitted from each beam source
diverges in at least one direction. For example, in embodiments
including a single-beam source edge emitting laser diode or
multi-beam source laser diode bar, the beam emitted from each beam
source may diverge in both a fast axis and a slow axis. Thus, in
such embodiments, if the device includes no optics downstream of
the beam source(s), the energy beam(s) exit the application end of
the device, and reach the target surface as an asymmetrically
diverging beam. Further, in embodiments including a VCSEL laser,
the emitted beam or beams may diverge symmetrically in both axes,
e.g., by about 15 degrees.
[0096] As discussed below, the divergence of energy beams delivered
by such embodiments of device 10 may provide an aspect of
eye-safety. In some embodiments, the arrangement of radiation
source 14 and/or the divergence of the beam(s) emitted from the
light source may provide Class 1M or better eye safety
classification per the IEC 60825-1 standard, as discussed
below.
[0097] In some embodiments, radiation source 14 may be configured
for and/or operated at any suitable wavelength to provide the
desired dermatological treatment. For example, radiation source 14
may be a laser configured for and/or operated at a wavelength that
is absorbed by water in the skin, e.g., between 1400 nm and 2000
nm, e.g., for certain photothermolysis or other treatments. In some
embodiments, radiation source 14 may be a laser configured for
and/or operated at a wavelength of between 1400 nm and 1550 nm,
e.g., for acne treatment or certain fractional non-ablative skin
treatments, e.g., skin rejuvenation or resurfacing, wrinkle
treatment, or treatment of pigmented legions (e.g., age spots, sun
spots, moles, etc.). In other embodiments, radiation source 14 may
be a laser configured for and/or operated at a wavelength of
between 1700 nm and 1800 nm, e.g., for sebaceous gland related
treatment like acne. In still other embodiments, radiation source
14 may be a laser configured for and/or operated at a wavelength of
about 1926 nm, e.g., for pigmented lesion treatment like solar
lentigo. As another example, radiation source 14 may be a laser
configured for and/or operated at a wavelength of about 810 nm for
providing hair removal treatment or melanin-based treatments. In
some embodiments that include multiple beam sources, different beam
sources may emit light at different wavelengths. For example, a
device may include one or more first beam sources that emit a
wavelength of about 1400 nm-1550 nm and one or more second beam
sources that emit a wavelength of about 1926 nm. As another
example, the wavelength may be in the UV (e.g., such as to effect
DNA or micro-organisms), may be in the visible spectrum (e.g., such
as to affect melanin, hemoglobin, oxyhemoglobin, or photosensitive
elements like mitochondria or fibroblasts) or in the IR spectrum
(e.g., such as to affect melanin, water, lipids). Likewise, the
radiation may be in the ultrasound spectrum (e.g., such as to
perform focused ultrasound fractional skin rejuvenation or
tightening) or in the radio frequency spectrum (e.g., such as to
perform fractional or bulk heating).
[0098] Radiation source 14 may be configured for or operated at any
suitable energy or power level. For example, in some embodiments,
radiation source 14 may emit a total energy of between about 2 mJ
and about 30 mJ per beam (i.e., per treatment spot). For example,
radiation source 14 may emit between about 5 mJ and about 20 mJ per
beam. In particular embodiments, radiation source 14 emits about 15
mJ per beam.
[0099] Further, radiation source 14 may deliver continuous wave
(CW) radiation, pulsed radiation, or in any other manner, depending
on the particular embodiment, application, or device setting. For
the purposes of this disclosure, pulsed or continuous wave
radiation refers to the radiation delivered out of application end
42 of device 10. Thus, radiation may be pulsed either by pulsing
the radiation source 14, by intermittently blocking the energy beam
emitted by radiation source 14, or otherwise intermittently
enabling and disabling the delivery of radiation out of application
end 42.
[0100] In some embodiments, device 10 controls radiation source 14
to provide CW or quasi-CW radiation, e.g., for bulk heating skin
tightening, hair removal, or acne treatment. In other embodiments,
device 10 provides pulsed radiation (e.g., by controlling pulsing
radiation source 14, by intermittently blocking the energy beam
emitted by radiation source 14, or otherwise), e.g., for fractional
treatment. For example, in some embodiments, device 10 may be a
laser-based device configured to sequentially deliver a series of
laser beams to the treatment area 40 to generate treatment spots
that are spaced apart from each other by areas of non-irradiated
skin between the adjacent treatment spots, to provide a fractional
treatment to the skin. Such embodiments may utilize any suitable
pulse parameters, e.g., pulse rate or frequency, pulse on time,
pulse off time, duty cycle, pulse profile, etc. In some
embodiments, radiation source 14 may be pulsed at a rate between
0.5 and 75 Hz. For example, radiation source 14 may be pulsed at a
rate between 2 and 30 Hz. In particular embodiments, radiation
source 14 may be pulsed at a rate between 10 and 20 Hz, e.g., about
15 Hz. The energy per pulse on a given treatment spot can be
achieved by a single pulse or by multiple repetitive pulses.
[0101] As used herein, a "pulse" may include both (a) a single,
continuous burst of radiation, and (b) one or more higher-frequency
pulses at substantially the same location (i.e., with substantially
overlapping areas of irradiation at the target plane), sometimes
referred to as a modulated pulse, pulse train, or super pulse. If
the time interval between the pulses in a pulse train is shorter
than the relaxation time of the mechanism of action (e.g., shorter
than the thermal relaxation time of a photothermolysis chromophore
target), then the pulse train can deliver substantially similar
results as a single longer pulse.
[0102] As used herein, a "treatment spot" means a contiguous area
of skin irradiated by a beam source--during a continuous period of
irradiation or during a pulse (as defined above)--to a degree
generally sufficient to provide a desired treatment in the skin at
that location. For some types of beam source, including laser beam
sources for example, the boundaries of the treatment spot are
defined by the "1/e.sup.2 width," i.e., the treatment spot includes
a contiguous area of the skin surface that is irradiated by a
radiation intensity equal to at least 1/e.sup.2 (or 0.135) times
the maximum radiation intensity at any point on the skin surface. A
treatment spot may include the full extent of the surface (or
volume) irradiated. A treatment spot may include the full extent of
the tissue being influenced by the irradiation, which may be
smaller than the irradiated area or volume, or may be larger (e.g.,
due to thermal conductivity). Further, reference to a treatment
spot "on the skin" or similar language refers to radiation pattern
on the skin which generally produces a radiation pattern within the
skin, whether or not it produces a treatment effect on the surface
of the skin.
[0103] A treatment spot includes any increased areas due to
smearing, blurring, or other elongation in any one or more
direction due to movement of the device across the skin, whether
the radiation source is providing pulsed or continuous wave (CW)
radiation. Thus, if the device is moved across the skin during CW
radiation (e.g., in a gliding mode operation), a treatment spot may
be many times larger than the size of the instantaneous irradiated
area of skin. If the device is moved across the skin during pulsed
radiation (e.g., in a gliding mode operation), a treatment spot may
be, for example, 10% to 500% larger than the size of the
instantaneous irradiated area of skin, depending on a number of
factors.
[0104] Certain embodiments of device 10 include one or more optics
16 downstream of radiation source 14 for directing or treating the
beam 60 emitted from radiation source 14 before reaching the target
surface. Optics 16 may allow for radiation source 14 to be
positioned at any desired distance from the application end 42 of
the device that contacts the skin during treatment (and thus at any
desired distance from the target surface). Embodiments of device 10
that include optics 16 downstream of radiation engine 12 are
referred to herein as "indirect exposure" embodiments.
[0105] Optics 16 may include any number and types of optical
elements, e.g., lenses, mirrors, and other elements, for delivering
the light generated by radiation engine 12 to the treatment area 40
and, if desired, for treating the beam, such as adjusting the
treatment spot 62 size, intensity, treatment spot location, angular
distribution, coherence, etc.
[0106] As used herein, an "optic" or "optical element" may mean any
element that deflects a light beam, influences the angular
distribution profile (e.g., angle of convergence, divergence, or
collimation) of a beam in at least one axis, influences the focus
of the beam in at least one axis, or otherwise affects a property
of the radiation. Thus, optics include mirrors and other reflective
surfaces, lenses, prisms, light guides, gratings, filters, etc. For
the purposes of this disclosure, optics do not generally include
planar or substantially planar transmissive elements such as
transmissive windows or films, such as those that serve as
transmissive aperture that protect internal components.
[0107] Other embodiments of device 10 do not include any optics 16
downstream of radiation source 14 for affecting or treating the
beam. Such embodiments are referred to herein as "direct exposure"
embodiments. Some direct exposure devices may include a window
(e.g., to protect radiation source 14 and/or other internal
components of device 10) that does not substantially affect the
beam 60. In some embodiments (e.g., certain embodiments including
one or more edge emitting laser diodes as the radiation source 14),
the radiation source 14 may be positioned very close to the
application end 42 of the device that contacts the skin during
treatment (and thus very close to the target surface). For example,
in some direct exposure devices, the radiation source 14 may be
positioned such that the emitting surface of the radiation source
14 is less or equal to 10 mm from the skin when the application end
42 is placed in contact with the skin, referred to herein as close
proximity embodiments.
[0108] Control systems 18 may be configured to control one or more
components of device 10 (e.g., radiation engine 12, fans 34,
displays 32, etc.). Control systems 18 may include, for example,
any one or more of the following: a radiation source control system
for controlling aspects of the generation, treatment, and delivery
of energy beams 60 to the user; a displacement-based control system
for controlling aspects of device 10 based on the determined
displacement of device 10 across to the skin (e.g., as device is
glided across the skin during treatment), e.g., relative to a prior
treatment position; a temperature control system; an eye safety
control system to help prevent exposure of the eyes (e.g., the
corneas) to the treatment radiation (an eye safety control system
may be omitted in embodiments in which the laser radiation emitted
from device 10 is inherently eye-safe, e.g., certain direct
exposure embodiments of device 10); and/or a battery/power control
system.
[0109] Control systems 18 may include one or more sensors 26 and/or
user interfaces 28 for facilitating user interaction with device
10, and control electronics 30 for processing data (e.g., from
sensors 26 and/or user interfaces 28) and generating control
signals for controlling various components of device 10. Control
electronics 30 may include one or more processors and memory
devices for storing logic instructions or algorithms or other data.
Memory devices may include any one or more device for storing
electronic data (including logic instructions or algorithms), such
as any type of RAM, ROM, Flash memory, or any other suitable
volatile and/or non-volatile memory devices. Logic instructions or
algorithms may be implemented as software, firmware, or any
combination thereof. Processors may include any one or more
devices, e.g., one or more microprocessors and/or microcontrollers,
for executing logic instructions or algorithms to perform at least
the various functions of device 10 discussed herein. Control
electronics 30 may include exclusively analog electronics or any
combination of analog and digital electronics.
[0110] Control systems 18 may control components or aspects of
device 10 based on feedback from sensors 26, user input received
via user interfaces 28, and/or logic instructions/algorithms. For
example, in some embodiments, control systems 18 may control the
operation of radiation engine 12 based at least on feedback from a
displacement sensor. Thus, for example, control systems 18 may
control radiation engine 12 based on signals from a displacement
sensor indicating that device 10 or treatment tip 42 has been
translated a certain distance across treatment area 40 from a prior
treatment position.
[0111] Control systems 18 may include, for example, a radiation
source control system for controlling aspects of the generation,
treatment, and delivery of energy beams 60 to the user; a
displacement-based control system for controlling aspects of device
10 based on the determined displacement of device 10 across the
skin (e.g., as device is glided across the skin during treatment),
e.g., relative to a prior treatment position; a temperature control
system; an eye safety control system to help prevent exposure of
the eyes (e.g., the cornea) to the treatment radiation; and a
battery/power control system. Such control systems 18 are discussed
in greater below with reference to FIG. 2 and subsequent
figures.
[0112] More specifically, control systems 18 may be configured to
control one or more operational parameters of device 10. For
example, control systems 18 may control the treatment level (e.g.,
low power level, medium power level, or high power level) or
treatment mode (e.g., gliding mode vs. stamping mode; or
rapid-pulse mode vs. slow-pulse mode; or initial treatment mode vs.
subsequent treatment mode; etc.), the status of radiation source 14
(e.g., on/off, pulse-on time, pulse-off time, pulse duty cycle,
pulse frequency, temporal pulse pattern, etc.), parameters of the
radiation (e.g., radiation wavelength, intensity, power, fluence,
etc.), the configuration or operation of one or more optical
elements (in certain indirect exposure embodiments), and/or any
other aspects of device 10.
[0113] Sensors 26 may include any one or more sensors or sensor
systems for sensing or detecting data regarding device 10, the
user, the operating environment, or any other relevant parameters.
For example, as discussed in greater detail below with respect to
FIG. 2, sensors 26 may include one or more of the following types
of sensors: (a) one or more displacement sensor for determining the
displacement of device 10 relative to the skin, (b) one or more
motion/speed sensor for determining the speed, rate, or velocity of
device 10 moving ("gliding") across the skin, (c) one or more
skin-contact sensor for detecting proper contact between device 10
and the skin, (d) one or more pressure sensor for detecting the
pressure of device 10 pressed against the skin, (e) one or more
temperature sensor for detecting the temperature of the skin, a
region of the skin, and/or components of device 10, (f) one or more
radiation sensor for detecting one or more parameters of radiation
(e.g., intensity, fluence, wavelength, etc.) delivered or
indicative of delivered to the skin, (g) one or more color/pigment
sensor for detecting the color or level of pigmentation in the
skin, (h) one or more eye safety sensor for preventing unwanted eye
exposure to light from radiation source 14, (i) one or more dwell
sensor for detecting if the device is stationary or essentially
stationary with respect to the skin, (j) one or more roller-type
sensors for detecting the displacement and/or glide speed of the
device, and/or any (k) other suitable types of sensors.
[0114] User interfaces 28 may include any systems for facilitating
user interaction with device 10. For example, user interfaces 28
may include buttons, switches, knobs, sliders, touch screens,
keypads, devices for providing vibrations or other tactile
feedback, speakers for providing audible instructions, beeps, or
other audible tones; or any other methods for receiving commands,
settings, or other input from a user and providing information or
output to the user. User interfaces 28 may also include one or more
displays 32, one or more of which may be touch screens for
receiving user input. One or more user interfaces 28 or portions
thereof may be included in a separate housing from the treatment
device, such as in a smart charging dock or a personal computer,
and the treatment device may communicate with the separate housing
via hardwire (such as a cable or jack), wireless methods (such as
infrared signals, radio signals, or Bluetooth), or other suitable
communication methods.
[0115] Power supplies 20 may include any one or more types and
instances of power supplies or power sources for generating,
conditioning, or supplying power to the various components of
device 10. For example, power supplies 20 may comprise one or more
rechargeable or non-rechargeable batteries, capacitors,
super-capacitors, DC/DC adapters, AC/DC adapters, and/or
connections for receiving power from an outlet (e.g., 110V wall
outlet). In some embodiments, power supplies 20 include one or more
rechargeable or non-rechargeable batteries, e.g., one or more Li
containing cells or one or more A, AA, AAA, C, D, prismatic, or 9V
rechargeable or non-rechargeable cells.
Control Systems
[0116] FIG. 2 illustrates example components of control systems 18
for controlling aspects of device 10, according to certain
embodiments. Control systems 18 may include control electronics 30,
sensors 26, user interfaces 28, and a number of control subsystems
52. Control subsystems 52 are configured to control one or more
components of device 10 (e.g., radiation engine 12, fans 34,
displays 32, etc.). In some embodiments, control subsystems 52 may
include a radiation source control system 130, a displacement-based
control system 132, a user interface control system 134, a
temperature control system 136, a battery/power control system 138,
and/or any other suitable control systems for controlling any of
the functionality disclosed herein. User interface control system
134 may include a user interface sensor control system 140 and a
user input/display/feedback control system 142.
[0117] Each control subsystem 52 may utilize any suitable control
electronics 30, sensors 26, user interfaces 28, and/or any other
components, inputs, feedback, or signals related to device 10.
Further, any two or more control systems may be at least partially
integrated. For example, the functionality of control systems
130-138 may be at least partially integrated, e.g., such that
certain algorithms or processes may provide certain functionality
related to multiple or all control systems 130-138.
[0118] Each control subsystem 52 (e.g., subsystems 130-138) may be
configured to utilize any suitable control electronics 30, sensors
26, and user interfaces 28. In some embodiments, control
electronics 30 may be shared by more than one, or all, control
subsystems 52. In other embodiments, dedicated control electronics
30 may be provided by individual control subsystems 52.
[0119] Control electronics 30 may include one or more processors
150 and memory device 152 for storing logic instructions or
algorithms 154 or other data. Memory devices 152 may include any
one or more device for storing electronic data (including logic
instructions or algorithms 154), such as any type of RAM, ROM,
Flash memory, or any other suitable volatile and/or non-volatile
memory devices. Logic instructions or algorithms 154 may be
implemented as hardware, software, firmware, or any combination
thereof. Processors 150 may include any one or more devices, e.g.,
one or more microprocessors and/or microcontrollers, for executing
logic instructions or algorithms 154 to perform at least the
various functions of device 10 discussed herein. Control
electronics 30 may include exclusively analog electronics or any
combination of analog and digital electronics.
[0120] Sensors 26 may include any one or more sensors or sensor
systems for sensing or detecting data regarding device 10, the
user, the operating environment, or any other relevant parameters.
For example, sensors 26 may include one or more of the following
types of sensors:
[0121] (a) At least one displacement sensor 100 for detecting,
measuring, and/or calculating the displacement of device 10
relative to the skin 40, or for generating signals from which the
displacement is determined. In some embodiments, e.g., as discussed
below with reference to FIGS. 37-43, displacement sensor 100 may be
a single-pixel sensor configured to determine a displacement of
device 10 by identifying and counting intrinsic skin features in
the skin. In other embodiments, e.g., as discussed below with
reference to FIGS. 44-45, displacement sensor 100 may be a
multiple-pixel sensor, such as a mouse-type optical imaging sensor
utilizing a two-dimensional array of pixels.
[0122] In other embodiments, e.g., as discussed below with
reference to FIGS. 46A-46F, displacement sensor 100 may be a
roller-type sensor 118 in which the amount of roller rotation
indicates the linear displacement of the device. For example, a
roller-type sensor displacement sensor 100 may include a mechanical
roller having one or more indicia, a detection device (e.g., an
optical or other scanner) for identifying such indicia as they roll
past the detection device, and processing electronics for
determining the displacement of device 10 based on the detection of
such indicia. In some embodiment, the roller may also be actively
driven by a motor to facilitate a gliding treatment.
[0123] In still other embodiments, displacement sensor 100 may
comprise a capacitive sensor, as described below. Displacement
sensor 100 may use any number of other devices or techniques to
calculate, measure, and/or calculate the displacement of device
10.
[0124] Displacement sensor 100 may be used for (i) detecting,
measuring, and/or calculating linear displacements of device 10 in
one or more directions, (ii) detecting, measuring, and/or
calculating the degree of rotation traveled by device 10 in one or
more rotational directions, or (iii) any combination thereof.
[0125] (b) At least one motion/speed sensor 102 for detecting,
measuring, and/or calculating the rate, speed, or velocity of
device 10 moving across the treatment area 40 (the "manual glide
speed"), or for generating signals from which the manual glide
speed is determined;
[0126] (c) At least one skin-contact sensor 104 for detecting
contact between device 10 and the skin or treatment area 40. For
example, device 10 may include one or more capacitive contact
sensors 104 for detecting contact with the user's skin.
[0127] (d) At least one pressure (or force) sensor 106 for
detecting the pressure (or force) of device 10 against the skin or
treatment area 40.
[0128] (e) At least one temperature sensor 108 for detecting the
temperature of the treatment area 40, a region of the treatment
area 40 (such as the treatment spot 62 before, during, and/or after
treatment), components of device 10, or other object.
[0129] (f) At least one radiation sensor 110 for detecting levels
or other parameters of radiation delivered to the treatment area 40
or indicative of the radiation delivered to the treatment area 40
(e.g., per light pulse, per individual beam/treatment spot, per
delivered array of scanned beams/treatment spots 62, per a specific
number of individual delivered beams/treatment spots 62 or scanned
arrays of beams/treatment spots 62, or per a specific time period).
For example, device 10 may include a photodiode to measure the
pulse duration of the treatment beam.
[0130] (g) At least one color/pigment sensor 112 for detecting the
color or level of pigmentation in the treatment area 40.
[0131] (h) At least one eye safety sensor 114 for helping to
prevent unwanted eye exposure to light from the treatment radiation
source 14. Example eye safety sensors 114 are discussed below with
reference to FIGS. 48-51.
[0132] (i) At least one dwell sensor 116 for detecting whether
device 10 is stationary or essentially stationary with respect to
the skin.
[0133] (j) At least one roller-based sensor 118 that may be used as
a displacement sensor 100, a motion/speed sensor 102, a dwell
sensor 116 or all, for detecting signals indicative of the
displacement of device 10, the manual glide speed of device 10, or
stationary status of device 10, or both.
[0134] (k) any other type of sensors.
[0135] User interfaces 28 may include any systems for facilitating
user interaction with device 10, e.g., displaying data or providing
feedback to a user visually and/or audibly, and/or palpably (e.g.,
via vibration), and receiving commands, selections, or other input
from the user. For example, user interfaces 28 may include one or
more displays 32 (one or more of which may be interactive touch
screens), one or more manual devices 160 (e.g., buttons, switches,
knobs, sliders, touch screens, keypads, etc.), one or more speakers
162, and/or any other devices for providing data, information, or
feedback to a user or receiving input or information from a
user.
[0136] Control subsystems 52 may be configured to control one or
more controllable operational parameters of device 10, based on
feedback from sensors 26, user input received via user interfaces
28, and/or execution of logic instructions/algorithms 154. As used
herein, "controllable operational parameters" may include any
aspects or parameters of device 10 that may be controlled by any of
control subsystem 52.
[0137] For example, one or more control subsystems 52 may control
any aspects of the operation of radiation source 14, such as for
example:
[0138] (a) selecting and/or switching the treatment mode (discussed
below),
[0139] (b) controlling the on/off status of radiation engine 12
(which may involve controlling individual light sources separately
or as a group), and the timing of such on/off status: e.g.,
pulse-on time (pulse width), pulse-off time, pulse duty cycle,
pulse frequency, temporal pulse pattern, etc.,
[0140] (c) controlling one or more parameters of the radiation:
e.g., wavelength, intensity, power, fluence, etc. (e.g., by
controlling the power supplied to radiation engine 12), and/or
[0141] (d) controlling any other aspect of radiation source 14.
[0142] Control subsystems 52 (e.g., control systems 130-138) may
control components or aspects of device 10 based on feedback from
sensors 26, user input received via user interfaces 28, and/or
logic instructions/algorithms 154. For example, in some
embodiments, control system 130 may control the operation of
radiation source 14 based on feedback from a displacement sensor
100 and skin contact sensor(s) 104. As another example, control
system 130 may control the operation of radiation source 14 based
on feedback from a displacement sensor 100, skin contact sensors
104, and an eye safety sensor 114. In other embodiments, control
system 130 may control the operation of radiation source 14 based
on feedback from a glide rate sensor 102 and skin contact sensor(s)
104. In other embodiments, control system 130 may control the
operation of radiation source 14 based on feedback from a dwell
sensor 116 and skin contact sensor(s) 104. In other embodiments,
control system 130 may control the operation of radiation source 14
based on feedback from both a displacement sensor 100 or dwell
sensor 116 and a glide rate sensor 102, in addition to one or more
other sensors 104-116.
[0143] FIG. 3 illustrates a functional block diagram of an example
device 10, according to certain example embodiments. Device 10 may
include various components contained in a housing 24, including a
radiation engine 12, optics 16 (omitted in certain embodiments, as
discussed herein), control systems 18, displays 32, a power source
(in this example, a battery) 22, various sensors 26, and a cooling
fan 34 (omitted in certain fully-solid-state embodiments, as
discussed herein).
[0144] Radiation engine 12 may include one or more radiation
sources 14 (e.g., one or more lasers), a heat sink or other cooling
system 36, and in some embodiments, optics 16 (e.g., a fast-axis
cylindrical lens coupled to a laser package and positioned
immediately downstream of an edge emitting laser diode).
[0145] As discussed above, optics 16 (which are excluded in direct
exposure embodiments, as discussed herein) may include any number
and types of optical elements, e.g., lenses, mirrors, and other
elements, for delivering (e.g., directing and/or routing) an energy
beam 60 from radiation engine 12 to the treatment area 40 and/or
for treating the beam 60, such as adjusting the treatment spot
size, intensity, treatment spot location, angular distribution,
coherence, etc.
[0146] In the illustrated embodiment, device 10 may include a
displacement sensor 100, skin contact sensor(s) 104, and/or an eye
safety sensor 114 (and/or other sensors discussed herein).
Displacement sensor 100 may monitor the lateral displacement of
device 10 relative to the skin, e.g., as device 10 is moved across
the skin in a gliding mode or stamping mode of operation. Skin
contact sensors 104 may determine whether device 10, in particular
an application end (or "treatment tip") 42, is in contact with or
sufficiently close to the skin for providing treatment to the user.
Eye safety sensor 114 may determine whether the application end 42
of device 10, e.g., a treatment window 44 or output aperture, is
positioned over the skin or the cornea, such that device 10 be
controlled (e.g., radiation source 14 turned off) when the cornea
is detected, in order to prevent unintended exposure of the
cornea.
[0147] As discussed above, control systems 18 may include any
suitable subsystems for controlling the various components and
aspects of device 10. In this example, control systems 18 include a
radiation source control system 130, a displacement-based control
system 132, a user interface control system 134, a temperature
control system 136, and a battery/charger control system 138. Each
control subsystem 130-138 may utilize or interact with control
electronics 30, sensors 26 (e.g., sensors 100, 104, and/or 114),
and user interfaces 28.
[0148] Radiation source control system 130 may monitor and control
various aspects of radiation source 14. For example, system 130 may
turn radiation source 14 on and off, and monitor and control the
intensity of generated light or other radiation (e.g., by
controlling the current to radiation source 14). As another
example, in embodiments or configurations in which radiation source
14 is pulsed, system 130 may monitor and/or control the pulse
frequency, pulse on time, pulse off time, pulse duration, pulse
wave profile, duty cycle, or any other parameters of the pulsed
delivery. As another example, system 130 may monitor the
temperature of laser radiation source 14, which data may be used by
temperature control system 136, e.g., for controlling fan 34. In
addition, system 130 may turn radiation source 14 off, or reduce
power to radiation source 14 based on the monitored temperature of
laser radiation source 14 (e.g., to prevent overheating). Radiation
source control system 130 may utilize data or signals from any
other control subsystems (e.g., user interface control system 134,
temperature control system 136, and/or battery/charger control
system 138) for controlling aspects of laser radiation source
14.
[0149] User interface control system 134 may include a user
interface sensor control system 140 for monitoring and controlling
displacement sensor 100, skin contact sensors 104, and/or eye
safety sensor 114. For example, system 134 may receive signals
detected by each sensor, and send control signals to each sensor.
User interface control system 134 may include a user
input/display/feedback control system 142 for monitoring and
controlling user interfaces 28 and displays 32. For example, system
134 may receive user input data from various user interfaces 28,
and control information communicated to the user via displays 32
(e.g., visually, audibly, and/or palpably). User interface control
system 134 may communicate data or signals with, or otherwise
cooperate with, other control subsystems, e.g., radiation source
control system 130, temperature control system 136, and/or
battery/charger control system 138.
[0150] Temperature control system 136 may be configured to monitor
and control the temperature of one or more components of device 10,
e.g., radiation source 14, battery 20, etc. Thus, temperature
control system 136 may receive data from one or more temperature
sensors 108, and control one or more fans 34 based on such data. In
addition to controlling fan(s) 34, temperature control system 136
may generate control signals for controlling radiation source 14,
motor 120, etc. based on temperature data. For example, temperature
control system 136 may communicate signals to radiation source
control system 130 to turn off or otherwise control radiation
source 14 to avoid overheating (or in response to a detected
overheating) of such component(s), to maintain such components
within predefined performance parameters, or for any other purpose.
Temperature control system 136 may communicate data or signals
with, or otherwise cooperate with, radiation source control system
130, user interface control system 134, and/or battery/charger
control system 138.
[0151] Battery/charger control system 138 may be configured to
monitor and control the charging of battery 20. In some
embodiments, multiple batteries 20 are included in device 10. In
some embodiments, battery 20 may be removable from device 10, e.g.,
for replacement or as a consumable element (e.g., with optionally a
unique hardware design or electronic encryption or other means to
make proprietary). As shown in FIG. 3, device 10 may be configured
for connection to a wall plug-in charger 170 and/or a charging
stand 172 via control electronics 30, for charging battery 20.
System 138 may monitor the current charge and/or temperature of
battery 20, and regulate the charging of battery 20 accordingly.
Battery/charger control system 138 may communicate data or signals
with, or otherwise cooperate with, other control subsystems, e.g.,
user interface control system 134, temperature control system 136,
and/or battery/charger control system 138. In other embodiments,
e.g., where power supply comprises one or more cells (e.g., size A,
AA, AAA, C, D, prismatic, or 9V cells), battery/charger control
system 138, wall plug-in charger 170, and charging stand 172 may be
omitted. Other embodiments may include a power cord connected to
mains supply, an electronic power supply, or other sources of
power. Such embodiments may still be substantially hand-held.
[0152] Device 10 may include a delivery end, referred to herein as
application end 42, configured to be placed against the skin, in
particular treatment area 40. Application end 42 may include or
house various user interfaces, including the treatment delivery
interface for delivering beams 60 to the user, as well as one or
more sensors 26 for detecting various characteristics of the target
surface and/or treatment delivered by device 10. For example, in
the illustrated embodiment, application end 42 provides an
interfaces for displacement sensor 100, skin contact sensors 104,
and/or eye safety sensor 114, allowing these sensors to interface
with the user's or patient's skin or tissue. In some embodiments,
application end 42 provides a window 44 through which beams 60 are
delivered.
Operation of Device 10
[0153] As discussed above, device 10 is configured to deliver one
or more energy beams 60 to a treatment area 40 to provide a desired
dermatological treatment. Device 10 may deliver beam(s) 60 to
generate various treatment patterns in the treatment area 40. For
example, various treatment patterns may be generated by any
combination of the following: operating device 10 in a manual
gliding mode, operating device 10 in a stamping mode, providing
continuous wave (CW) radiation, providing pulsed radiation,
providing direct exposure radiation, providing indirect exposure
radiation, providing close proximity radiation, providing remote
proximity radiation, any other modes, or any combination
thereof.
[0154] Each energy beam 60 from device 10 may form an irradiated
treatment spot "treatment spot") 62 on the surface of the skin, and
(in certain embodiments) a three-dimensional volume of thermally
damaged skin extending below the surface of the skin, referred to
herein as a micro thermal zone (MTZ) 64. Each MTZ may extend from
the skin surface downward into the skin, or may begin at some depth
below the skin surface and extend further downward into the skin,
depending on the embodiment, device settings, or particular
application. In embodiments or situations in which the irradiated
area on the skin moves across the skin during delivery of the
radiation, referred to as "blurring" or "smearing" of the
irradiated area (e.g., as caused by movement of the device during a
gliding mode operation of device 10, wherein the delivered beam 60
remains stationary with respect to the device housing 24), the
treatment spot 62 is defined as the collective area swept by the
moving irradiated area throughout a continuous (i.e.,
uninterrupted) period of radiation delivery to the skin at that
location. Some embodiments may compensate for blur by tracking
device motion across the skin and dynamically adjusting the
location or direction of the delivered beam 60 with respect to the
device housing 24, or by the configuration of light sources or
scanning modes, or in other ways.
[0155] In some applications, such as hair removal treatment, beams
60 may generate treatment spots 62 to cause thermal injury of hair
follicles. In other applications, such as fractional treatment for
example, beams 60 (e.g., laser beams) may generate treatment spots
62 to cause thermal injury to the skin, e.g., ablative or
non-ablative lesions.
[0156] In some embodiments, device 10 is configured to be used in a
"gliding mode" in which the device is manually dragged or glided
across the skin while delivering continuous wave (CW) radiation or
pulsed radiation to the treatment area 40, e.g., to create
continuous elongated treatment spots 62 in the direction of
gliding, or alternatively to create rows or arrays of discrete
treatment spots 62 (spaced apart, touching, or overlapping) in the
direction of gliding.
[0157] In other embodiments, device 10 is configured to be used in
a "stamping mode" in which device 10 is held relatively stationary
at different locations on the skin. At each location on the skin,
device 10 may deliver one or more beams 60 to generate one or more
corresponding treatment spots 62 on the skin. Thus, device 10 may
be positioned at a first location, one or more treatment spots 62
may then be delivered to the skin while device 10 is held
relatively stationary, device 10 may then be moved--e.g., by
lifting and repositioning device 10, or by gliding device 10 across
the surface of the skin--to a new location on the skin, and one or
more treatment spots 62 may then be generated at that location
(e.g., by automated or manual pulsing of the radiation sources(s)
14), and so on, in order to cover a treatment area 40 as
desired.
[0158] In some embodiments, device 10 may be configured to generate
an array of MTZs 62 in the skin that are laterally spaced apart
from each other by volumes of untreated (i.e., non-irradiated or
less irradiated) skin, e.g., to provide a fractional treatment. For
example, the application end 42 of device 10 may be manually moved
across the surface of the skin during a treatment session. Energy
beams 60 may be pulsed during the movement of device 10 across the
skin (in a gliding mode operation), or between intermittent
movements of device 10 across the skin (in a stamping mode
operation). The skin's healing response, promoted by the areas of
untreated skin between adjacent MTZs 64, may provide benefit in the
treatment area (e.g., skin resurfacing or rejuvenation, wrinkle
removal or reduction, etc.).
Direct Exposure and/or Close Proximity
[0159] As discussed above, some embodiments of device 10 are
"direct exposure devices" that do not include any optics 16
downstream of radiation source(s) 14 for delivering or treating
beam(s) 60. However, some direct exposure devices may include a
planar or substantially planar window 44 (e.g., a thin sapphire or
BK-7 like glass window or a thin film or equivalent) downstream of
radiation source(s) 14, e.g., to protect the radiation source(s)
and/or other internal components of the device.
[0160] In embodiments that use a relatively rapidly divergent beam
source (e.g., edge emitting laser diodes, laser diode bars, and
certain VCSELs), due to the rapid divergence of beam(s) 60 emitted
from the radiation source(s) 14, the radiation source(s) 14 may be
positioned very close to the application end 42 of the device that
contacts the skin during treatment (and thus very close to the skin
surface). For example, in some direct exposure devices, the
radiation source(s) 14 may be positioned such that the emitting
surface(s) of the radiation source(s) 14 are arranged at less than
or equal to 10 mm of the skin during treatment, referred to herein
as a close proximity configuration. In some embodiments, the
emitting surface(s) of the radiation source(s) 14 are arranged at a
distance of less than or equal to 5 mm, 2 mm, 1 mm, 500 .mu.m, 200
.mu.m, or even 100 .mu.m from the surface of the skin when the
application end 42 is placed in contact with the skin.
[0161] Some direct exposure embodiments of device 10 may be
configured to provide CW radiation in a gliding mode. For example,
as discussed below with respect to FIGS. 24A and 24B, direct
exposure embodiments of device 10 including a high fill-factor
laser diode bar 14C may be operated in a CW mode while the device
is manually glided across the skin in a direction generally
perpendicular to the elongated direction of the laser diode bar, to
generate a continuous elongated treatment spot 62 in the manual
glide direction, having a width generally corresponding to the
width of the laser diode bar. The device may be glided multiple
times across the skin at adjacent locations to cover a desired
treatment area 40, e.g., to provide a hair removal treatment.
[0162] Other direct exposure embodiments of device 10 may be
configured to provide pulsed radiation in a gliding mode, e.g., to
provide a fractional treatment. For example, as discussed below,
direct exposure embodiments of device 10 including one or more edge
emitting laser diodes, laser diode bars, or VCSELs may be operated
in a pulsed manner while the device is manually glided across the
skin to generate a generally one-dimensional or two-dimensional
array of treatment spots 62 for each glide of the device 10 across
the skin. The device may be glided multiple times across the skin
at adjacent locations and over the same area to cover a desired
treatment area 40, e.g., to provide a fractional treatment.
Example Embodiment of Device 10
[0163] FIGS. 4-7 illustrate an example embodiment of device 10
configured as a direct exposure device for providing fractional
treatment. As shown in FIG. 4, the example device 10 may include a
laser engine 12 including one or more lasers (e.g., one or more
edge emitting laser diodes, laser diode bars, or VCSELs) configured
to emit one or more pulsed laser beams 60, and one or more
batteries 20, both housed in a device housing 24. In some
embodiments, laser engine 12 includes a single beam source
configured to emit a single pulsed beam 60, e.g., an edge emitting
laser diode or a VCSEL configured to emit a single beam 60. In
other embodiments, laser engine 12 includes multiple beam sources
configured to emit multiple discrete pulsed beams 60, e.g.,
multiple edge emitting laser diodes, an laser diode bar, multiple
laser diode bars, multiple VCSELs, or a VCSEL configured to emit
multiple discrete beams 60 (e.g., as discussed below with reference
to FIGS. 30-34), for example.
[0164] Battery or batteries 20 may include any number and type of
batteries, e.g., A-sized or smaller batteries, or rechargeable or
non-rechargeable cells (e.g., Li ion, lithium ferro phosphate,
NiMH, NiCAD, or other cells), or any other type of battery.
[0165] Device 10 has an application end 42 configured to contact
the user's skin as device 10 is moved across the skin during a
treatment session. In this embodiment, application end 42 is
defined by a leading end of laser engine 12, which projects from
device housing 24. The application end 42 may include a laser
treatment aperture 220 through which one or more laser beam(s) 60
generated by the laser engine 12 are delivered to the skin 40.
[0166] In addition, device 10 may include one or more sensors 26,
e.g., any one or more of the various types of sensors 26 disclosed
herein. For example, device 10 may include one or more skin contact
sensors 104, a displacement sensor 100, a motion/speed sensor 102,
a dwell sensor 116, and/or an eye safety sensor 114. The one or
more sensors 26 may be located at any suitable location(s) on
device 10, e.g., at or near application end 42. In some
embodiments, device 10 includes a skin contact sensor 104 and a
displacement sensor 100 configured to avoid unintentional exposure
and/or overexposure of the skin (e.g., by preventing stacking or
overlapping of treatment spots 62). The skin contact sensor 104 and
displacement sensor 100 may be provided by a single combined
contact/displacement sensor, or may be provided as separate
sensors. Such sensor(s) may be optical or capacitance-based or use
any other suitable means. Contact with the skin may be detected by
analyzing an amplitude of an optical reflectance or capacitance
signal generated by the sensor. Further, dwelling of device 10 on
the skin may be detected by analyzing signal in the optical
reflectance or capacitance signal associated with application end
42 of device 10 moving across the skin or by other suitable means.
Because skin surface is not perfectly smooth and the manual moving
of a device cannot achieve perfect steady motion, stiction (static
friction) between device 10 and skin and/or other physical
principles result in micro-displacement (non-lateral) between the
sensor and the skin surface. For example, a capacitive sensor's
signal is inversely proportional to the relative distance between
the sensor and the test surface. Any micro-displacement due to
natural stick-and-slip movement across the skin will result in a
translational signal on top of the nominal steady-state sensor
signal. This signal may be analyzed to determine whether device 10
is moving across the skin, or dwelling at the same location. Such
analysis may include any suitable algorithms, e.g., comparing the
signal to one or more threshold values.
[0167] In the example shown in FIG. 4, device 10 includes a manual
power button 200. Device 10 enables the delivery of beams to the
skin in a pulsed manner while power button 200 remains depressed by
the user, and the sensor(s) 26 detect that device 10 is in proper
contact with the skin and has translated, is moving with a certain
velocity range, and/or is not dwelling. In other embodiments, the
power button may be a simple on/off switch and the light pulsing is
controlled only, for example, by one or more sensors and not the
manual power button.
[0168] The specific user interface scheme, and the shape and size
of the device housing 24 may be configured as desired. In some
embodiments, the shape and size of device housing 24 is easy to
grip and includes a simple, conveniently located power button 200
and/or other user interfaces 28. In addition, the shape of device
10 may be ergonomic, and/or be configured to provide good
visibility of the treatment area 40. Example shapes are
pencil-like, pen-like, lipstick-like, organic shapes like pebbles,
cigarette lighter-like, and numerous other shapes.
[0169] FIGS. 5A, 5B, and 6 illustrate details of an example laser
engine assembly 12 for use in the example direct exposure
fractional treatment device of FIG. 4, according to certain
embodiments. In particular, FIGS. 5A and 5B illustrate an assembled
view of the example laser engine 12, while FIG. 6 illustrates an
exploded view of the various components of device 10.
[0170] In some embodiments, the laser engine 12 may include an edge
emitting laser diode 14 directly mounted to a thermal reservoir
heat sink 36 via any suitable manner (e.g., via soldering,
clamping, or adhesive) or mounted to one or more subcarriers (e.g.,
a ceramic, plated ceramic, copper block, etc) to provide electrical
isolation and/or thermal conduction, for example. Electrical
connection to the edge emitting laser diode 14 may be made by wire
bonding, soldering, clamping, or other suitable means between the
edge emitting laser diode 14 and the subcarrier(s), to the heat
sink 36, or to other electrical connection point(s) (e.g., a
printed circuit board) in device 10. In some embodiments, the laser
engine assembly 12 may include an edge emitting laser diode chip
mounted on a heat spreader, which is in turn mounted to heat sink
36.
[0171] In some embodiments, the heat sink 36 may also be an
internal chassis for supporting other components of laser engine
12. In some embodiments, the light output (power and wavelength) of
the edge emitting laser diode 14 may be sensitive to temperature
and should be held to a predetermined maximum temperature rise
(e.g., about 25.degree. C.). Thus, the heat sink 36 may include a
temperature feedback system to automatically disable the laser if
the maximum temperature is exceeded.
[0172] The edge emitting laser diode may be powered by one or more
batteries 20, by way of a momentary switch 210 (activated by power
button 200 shown in FIG. 4) and pulsing electronics 212, which
control the pulsing of the edge emitting laser diode 14. The
components shown in FIG. 6 may be contained in a laser engine
housing 24, which may include housing sections held together by any
suitable fasteners. As discussed above, other light sources, e.g.,
an laser diode bar or VCSEL (or multiple edge emitting laser
diodes, laser diode bars or VCSELs), may be used instead of a
single edge emitting laser diode. Furthermore, other power supply
sources 20 may be used, such as a rechargeable battery (e.g., L-ion
battery), mains electricity, or a super-capacitor, for example.
[0173] FIGS. 5A and 5B also show an example configuration of the
application end 42 of the laser engine assembly 12, which may
include a window 44 covering an aperture 220 through which the
laser beam 60 is delivered from the edge emitting laser diode 14 to
the skin. In this embodiment, window 44 comprises a transparent
layer or pane (e.g., sapphire, glass, or plastic) positioned over
aperture 220 to protect the internal components of laser engine 12.
In other embodiments, aperture 220 may be open or laser engine 12
may be protected by a transparent (to edge emitting laser diode 14)
encapsulant, such as suitable epoxy or spun-on-glass, rather than
window 44. Aperture 220 may have any suitable size and shape. Laser
engine assembly 12 may act as application end 42 of device 10, and
thus contact the skin directly. Application end 42 may also form
part of one or more of the sensors 26, such as providing a
capacitive antenna for a skin contact sensor. Window 44 may project
beyond an outer surface 218 of application end 42, may be arranged
flush with outer surface 218 of application end 42, or may be
recessed from outer surface 218 of application end 42.
[0174] In some embodiments, device 10 shown in FIGS. 4-7 is
configured as a direct exposure, close proximity device, as such
terms are defined herein. As discussed above, a
non-optically-powered transparent layer or pane, or encapsulant,
may be positioned between the edge emitting laser diode 14 and the
target surface, or there may be nothing but an air gap between the
edge emitting laser diode 14 and the target surface.
[0175] In some embodiments, the emitting surface of edge emitting
laser diode 14 is configured to be located within 5 mm of the
target skin surface. In certain embodiments, the emitting surface
82 of edge emitting laser diode 14 is configured to be located
within 2 mm of the target skin surface, to provide a desired beam
spot size and intensity at the target surface. In some embodiments,
the emitting surface 82 of edge emitting laser diode 14 is
configured to be located within 1 mm of the target skin surface, to
provide a desired beam spot size and intensity at the target
surface. In particular embodiments, the emitting surface 82 of edge
emitting laser diode 14 is configured to be located within 500
.mu.m, 200 .mu.m, or even 100 .mu.m of the target skin surface
during use. Due to the very small distance between the edge
emitting laser diode 14 and the target skin surface, as well as
lack of optics, the edge emitting laser diode 14 need not be
aligned with high precision.
[0176] In some embodiments, various aspects of device 10 (e.g., the
type of edge emitting laser diode 14, the distance between edge
emitting laser diode 14 and the skin surface, etc.) are configured
to produce treatment spots 62 on the skin having a diameter of less
than 2,000 .mu.m in the largest dimension. In particular
embodiments, the beam spot size on the target surface has a
diameter of less than 700 .mu.m in the largest dimension, which may
be suitable for certain treatments, e.g., treatment of solar
lentigo (age spots), wrinkles, and/or fine lines. In specific
embodiments, the beam spot size on the target surface has a
diameter of between about 75 .mu.m and about 350 .mu.m in the
largest dimension, which may be suitable for certain treatments,
e.g., treatment of wrinkle and/or fine lines. The diameters listed
above do not account for any "blurring" or "smearing" of the
treatment spots 62 caused by movement of device 10 across the skin
during the particular beam pulse. The actual diameter of particular
treatment spots 62 (in the direction of device 10 movement across
the skin) may thus be larger than the nominal diameters listed
herein, due to such blurring or smearing of spots 62.
[0177] In some embodiments, device 10 is configured to produce
treatment spots 62 having an area of less than 1.0 mm.sup.2. In
particular embodiments, device 10 is configured to produce
treatment spots 62 having an area of less than 0.4 mm.sup.2, which
may be suitable for certain treatments, e.g., treatment of solar
lentigo (age spots), wrinkles, and/or fine lines. In specific
embodiments, device 10 is configured to produce treatment spots 62
having an area of less than 0.1 mm.sup.2, which may be suitable for
certain treatments, e.g., treatment of wrinkle and/or fine lines or
pigmentation. Finally, in some embodiments, device 10 is configured
to produce treatment spots 62 having an area of less than 0.05
mm.sup.2, which may also be suitable for certain fractional
treatments. The treatment size areas listed above do not account
for any "blurring" or "smearing" of the treatment spots 62 caused
by movement of device 10 across the skin during the particular beam
pulse. Thus, the actual area of individual treatment spots 62 may
be larger than the areas listed above, due to such blurring or
smearing of spots 62.
[0178] In one example embodiment, device 10 is configured such that
the emitting surface of edge emitting laser diode 14 is less than 1
mm from the target skin surface, and edge emitting laser diode 14
has a nominal laser emitter area of about 100 .mu.m (in the slow
axis direction) by 5 .mu.m (in the fast axis direction). This
configuration may yield treatment spots 62 having an equivalent
nominal diameter of between about 150 .mu.m and about 350
.mu.m.
[0179] FIG. 7 illustrates portions of an example electrical
schematic of the laser pulsing electronics 212 for controlling the
pulsing the edge emitting laser diode 14 of the example embodiment
shown in FIGS. 4-6, according to one embodiment. In this
embodiment, the laser pulsing electronics 212 generate current
pulses through the edge emitting laser diode 14 at a fixed rate as
long as the signals from the appropriate sensor(s) 26 are valid and
the manual power button 200 is activated. The pulse energy may be
controlled via the pulse duration. A single-cell AA-sized Li
battery may be used to provide a drive current of about 7 Amps
through the edge emitting laser diode, to provide a laser output
power of about 3 Watts, sufficient to produce a desired tissue
response for particular applications or treatments, e.g., certain
fractional treatments.
[0180] As discussed above, the pulse rate may be set or selected
based on a typical or expected manual glide speed of device 10 is
across the skin. In particular, the pulse rate may be set or
selected such that for a range of typical or expected manual glide
speeds (e.g., between 2 cm/s and 6 cm/s), adjacent treatment spots
62 are physically separated from each other by areas of non-treated
skin, i.e., fractional treatment is provided. In some embodiments,
the pulse rate may be set or selected such that for a range of
typical or expected manual glide speeds (e.g., between 2 cm/s and 6
cm/s), adjacent treatment spots 62 are physically separated from
each other from a predetermined minimum non-zero distance, e.g.,
500
[0181] In some embodiments, device 10 may provide a pulse
repetition frequency ("PRF") between 1 and 50 Hz. For example,
device 10 may provide a PRF of between 5 and 25 Hz. In particular
embodiments, device 10 may provide a PRF of about 15 Hz.
[0182] In some embodiments, device 10 may be controlled to prevent,
limit, or reduce the incidence or likelihood of treatment spot
overlap, e.g., based on feedback from one or more sensors 26 (e.g.,
a displacement sensor 100, speed/motion sensor 102, and/or a dwell
sensor 116). In some embodiments, the pulse rate may be
automatically adjustable by device 10 and/or manually adjustable by
the user, e.g., to accommodate different manual movement speeds
and/or different comfort levels or pain tolerance levels of the
user.
[0183] FIG. 8A illustrates an example of a manually scanned pattern
of treatment spots 62 generated in a treatment area of skin 40 by
an embodiment of device 10 including a single beam source
configured to emit a single pulsed beam 60, e.g., a single edge
emitting laser diode or a single VCSEL configured to emit a single
beam 60. Device 10 is glided across the skin while the single beam
source is pulsed to create a pattern of spaced-apart treatment
spots 62. Each glide of the device in a particular direction
creates a generally linear array of treatment spots 62. A first
array produced by a first glide, or "manual scan," of device 10
across the skin is indicated at 92. five linear arrays of spots 62
corresponding to five manual scans 92 of device 10 are shown in
FIG. 8A. Device 10 may be manually scanned across the skin any
number of times and in any direction or directions to effectively
cover a particular treatment area 40. The treatment spot pattern
may therefore be random or quasi-random, unlike certain
mechanically scanned systems, which may have benefit, such as to be
less cosmetically detectable to the eye than a more regular
grid.
[0184] FIG. 8B illustrates an example of a manually scanned pattern
of treatment spots 62 generated in a treatment area of skin 40 by
an embodiment of device 10 including multiple beam sources
configured to emit multiple discrete pulsed beams 60, e.g.,
multiple edge emitting laser diodes, an laser diode bar, multiple
laser diode bars, multiple VCSELs, or a VCSEL configured to emit
multiple discrete beams 60 (e.g., as discussed below with reference
to FIGS. 30-34), for example. Device 10 is glided across the skin
while the multiple beam sources of device 10 are pulsed
(simultaneously, sequentially among the individual beam sources,
randomly, or otherwise, depending on the particular type of beam
sources and configuration of device 10) to create a pattern of
spaced-apart treatment spots 62. Each pulse of the multiple beam
sources generates a corresponding array of multiple treatment spots
62, indicated at 94 in FIG. 8B (in this example, 6 spots, such as
might be generated by a laser diode bar with 6 spaced emitters).
Thus, each manual glide of the device in a particular direction
creates a generally two-dimensional array of treatment spots 62.
Two manual glides, or "manual scans," of device 10 across the skin
are indicated at 92A and 92B. Device 10 may be manually scanned
across the skin any number of times and in any direction or
directions to effectively cover a particular treatment area 40. In
this example, treatment spots are elongated in the glide direction,
which could occur from "smearing" if compensation is not included,
or from the beam properties itself having a non-symmetric energy
profile.
[0185] FIGS. 8C-8J illustrate example manual glide, or "manual
scan," patterns for covering a particular treatment area 40 using
device 10. FIGS. 8C-8G illustrate example patterns in which device
10 is manually scanned in the same general direction (e.g., back
and forth along parallel or near-parallel directions). In some
treatments or applications, device 10 may be scanned in two or more
different directions, e.g., to form a criss-cross pattern, such as
shown in FIG. 8H, for example. This may yield a more uniform
coverage pattern. Other example manual scan patterns include a
generally spiral pattern, as shown in FIG. 8I, or a random pattern,
as shown in FIG. 8J. Certain treatment patterns may be preferred or
specified or configured, such as a series of one-dimensional
treatment lines that radiate outward from the eyebrow to achieve a
skin tightening effect analogous to a surgical eyebrow lift), for
any suitable benefit. Areas may also be treated in multiple passes,
e.g., to increase treatment spot density, increase randomness, or
other reason. Any other suitable manual scan patterns may be used
as appropriate.
[0186] FIG. 9 shows a three-dimensional cross-section of a volume
of skin for illustrating the process of a non-ablative fractional
treatment consisting of an array of MTZs in the skin 64. Each MTZ
64 is a small volume of denatured (or otherwise influenced, such as
photochemical or photobiological) epidermis and dermis generally
shaped as a column or elongated bowl and extending downward from
the skin surface or subsurface in a direction substantially
orthogonal to the skin surface. The damaged skin of the MTZ 64 is
surrounded by untreated (and thus not denatured, in this example)
skin. Because of the proximity of healthy skin cells, the damaged
skin of the MTZ 64 heals relatively quickly (as compared to
traditional non-fractional treatments, such as CO2 laser
resurfacing) and reduces wrinkles, scarring, and/or uneven
pigmentation as part of the healing process. During the healing
process, MENDS (microscopic epidermal necrotic debris) may be
formed. Since the MTZs typically cover only a fraction (e.g., less
than 1% to about 70% of the skin surface, side effects may be
substantially reduced as compared to traditional non-fractional
treatments, such as CO2 laser resurfacing. In some home-use
embodiments of this disclosure, coverage fraction may be between
0.25% and 5% of the skin per treatment. In some embodiments, device
10 is configured such that the size and shape (e.g., height and
width and depth) of the MTZs 64 spare many of the stem cells and
melanocytes in the papillary dermis.
Prevention of Treatment Spot Overlap
[0187] As discussed above, in some embodiments, device 10 may be
configured to prevent, limit, or reduce the incidence or likelihood
of treatment spot overlap, e.g., based on feedback from one or more
sensors 26 (e.g., a displacement sensor 100, speed/motion sensor
102, and/or a dwell sensor 116). For example, in some embodiments,
the pulse rate may be automatically adjustable by device 10 and/or
manually adjustable by the user, e.g., to accommodate different
manual movement speeds and/or different comfort levels or pain
tolerance levels of the user.
[0188] Some embodiments include other devices or techniques that
individually or in combination provide over-treatment protection,
e.g., to prevent pulse stacking, firing on the same area, an
excessive treatment spot 62 density, or other non-desirable
treatment conditions. For example, in some embodiments, device 10
ceases to operate (e.g., generate or deliver beams) when stationary
condition of device 10 is detected. A stationary condition may be
determined using one or more sensors, e.g., any one or more motion
sensors, speed sensors, dwell sensors, vibration and tilt sensors,
accelerometers, and/or displacement sensors. Such sensors may
generate signals based on capacitance, optical reflection,
remittance, scattering variation, acoustical reflection variation,
acoustical impedance, galvanic potential, potential difference,
dielectric constant variation, or any other parameter.
[0189] In some embodiments, device 10 uses local pyrometry (alone
or in combination with other techniques mentioned above) to detect
a stationary condition. The treatment beam area may be optically
measured by local thermal imaging of the skin, and a stationary
condition may be detected where local heating of the skin exceeds a
threshold temperature or other parameter value.
[0190] In some embodiments, device 10 fires an "encouragement
pulse" when a stationary condition is detected. For example, a
single non-damaging but higher than normal energy pulse (causing
discomfort but not damage) or a brief pulse train may be emitted if
a stationary condition is detected, to encourage the user to move
device 10.
[0191] A stationary condition may further be measured by bulk
heating measurement, for example. If the tip of the treatment
delivery device or the sensed skin temperature or region of skin
temperature begins to heat above a threshold, loss of motion is
detected, or excessive treatment in the area is detected.
[0192] As another example, device 10 may deliver heat or cold to
the skin to encourage motion, as dwelling in one location may
become uncomfortable. As another example, mechanical rollers may be
used to detect a non-motion condition. Alternatively, motorized
rollers may drive motion of device 10 across the skin, thus
physically avoiding a non-motion condition.
[0193] In some embodiments, physiological feedback based on beam
characteristics may be exploited, e.g., by designing the output for
treatment efficacy as well as perception of the presence of
treatment. For example, discomfort may be exploited such that
overtreatment is discouraged by pain feedback that increases with
excessive treatment.
[0194] In some embodiments, photobleaching may be used with
indigenous or exogenous substances. For example, the skin may be
treated with a dye that is photobleached by the treatment beam or
by a separate bleaching beam used to bleach the treated area and
potentially its surrounding areas. In this example, device 10 may
be configured to detect the presence of the unbleached dye and
would allow treatment only on areas with unbleached dye, thus
preventing repetitive treatment on the same area (since that would
be photobleached).
[0195] Any of the over-treatment protection systems or techniques
described above (expect those directly concerned with pulse
parameters) may be similarly incorporated in any CW radiation
embodiment, e.g., for a hair removal device.
Pulse Rate Frequency (PRF)
[0196] In embodiments that include a pulsed radiation source 14
(e.g., with one or more pulsed beam sources), the pulse rate
frequency (PRF) may be functionally interrelated with one or more
other configurational or operational parameters of device 10,
including (a) the manual glide speed, (b) spacing between treatment
spots generated by consecutive pulses, referred to herein as
"consecutive spot spacing," and (c) the amount of "smearing" or
"blurring" of individual treatment spots. The amount of "smearing"
or "blurring" of a treatment spot may be quantified by a "blur
factor," defined as the ratio of the area of the blurred treatment
spot 62 (with blurring caused by movement of device 10) to the area
of the instantaneous treatment spot size. Thus, to illustrate, a
blur factor of 1.0 indicates no blurring, a blur factor of 2.0
indicates a doubling of the treatment spot size area, and a blur
factor of 3.0 indicates a tripling of the treatment spot size
area.
[0197] Further, in at least some embodiments, the consecutive spot
spacing and the blur factor for any particular operation of device
10 are defined as a function of (a) the manual glide speed, (b) the
instantaneous spot size (i.e., the spot size at any particular
instant, thus ignoring any burring affects), and (c) any set of
parameters that defines the timing of a pulse sequence (referred to
herein as "pulse timing parameters," e.g., selected from pulse
duration (i.e., pulse on-time), delay between pulses (i.e., pulse
off-time), pulse rate frequency (PRF), duty cycle, etc.
[0198] In some embodiments, the pulse rate frequency (PRF) and/or
one or more other pulse timing parameters are controlled to provide
(a) a predefined or selected minimum consecutive spot spacing,
and/or (b) a predefined or selected maximum amount of spot blurring
(e.g., a predefined or selected maximum blur factor), and/or (c)
any other target parameter(s). "Controlling" the PRF and/or pulse
timing parameter(s) may include:
[0199] (a) device 10 selecting or setting the PRF and/or at least
one other pulse timing parameter, e.g.: [0200] (i) automatically
selecting a PRF and/or at least one other pulse timing parameter
based on a user-selected operational mode, treatment level, or
other user input, or [0201] (ii) automatically selecting a PRF
and/or at least one other pulse timing parameter independent of
user input (e.g., based on a device-selected operational mode,
treatment level, or other level, or based on a detected glide speed
during a portion of a treatment or a pre-treatment period of
operation (e.g., using a motion/speed sensor 102), based on a glide
speed detected and stored from a previously performed treatment
(e.g., using a motion/speed sensor 102), based on one or more
parameters detected by sensor(s) 26 in real time or otherwise
(e.g., as skin temperature detected by temperature sensor(s) 106,
or skin color detected by pigment sensor(s) 110, for example), or
based on any other any other data or signals collected in real time
or otherwise; and/or
[0202] (b) device 10 dynamically adjusting the PRF and/or at least
one other pulse timing parameter during a treatment session (e.g.,
in real time or substantially in real time), e.g., (i) based on
feedback from one or more sensors 26, e.g., device displacement
detected by displacement sensor(s) 100, glide speed detected by
motion/speed sensor(s) 102, skin contact sensor(s) 104, skin
temperature detected by temperature sensor(s) 106, delivered
radiation detected by radiation sensor(s) 108, skin color detected
by pigment sensor(s) 110, signals from eye safety sensor(s) 114,
dwell status detected by dwell sensor(s) 116, and/or device
displacement and/or glide speed detected by roller-based sensor(s)
118, and/or (ii) based on based on any other any other data or
signals collected in real time or otherwise.
[0203] As discussed above, in some embodiments, the PRF and/or at
least one other pulse timing parameter are controlled to provide
(a) a predefined or selected minimum consecutive spot spacing
and/or (b) a predefined or selected maximum amount of spot blurring
(e.g., a predefined or selected maximum blur factor).
[0204] For example, in some embodiments, the PRF and/or at least
one other pulse timing parameter are controlled to provide a
minimum consecutive spot spacing of 1 mm. Assuming a glide speed of
between 2 cm/s and 6 cm/s, and a spot size of between 200 .mu.m and
600 .mu.m, a PRF of 15 Hz, pulse duration of 3 ms, and duty cycle
of 4.5% may be selected to provide such spot spacing. At these
operational parameters, the resulting blur factor is about 130 to
190% for a spot size of 200 .mu.m, and about 110 to 130% for a spot
size of 600 .mu.m.
[0205] As another example, in some embodiments, the PRF and/or at
least one other pulse timing parameter are controlled to provide a
minimum consecutive spot spacing of 0.5 mm. Assuming a glide speed
of between 2 cm/s and 6 cm/s, and a spot size of between 300 .mu.m
and 600 .mu.m, a PRF of 30 Hz, pulse duration of 5 ms, and duty
cycle of 15% may be selected to provide such spot spacing. At these
operational parameters, the resulting blur factor is about 133 to
200% for a spot size of 300 .mu.m, and about 117 to 150% for a spot
size of 600 .mu.m.
[0206] In some embodiments, a PRF of between 1 and 50 Hz is
selected. For example, device 10 may provide a PRF of between 5 and
25 Hz. In particular embodiments, device 10 may provide a PRF of
about 15 Hz.
[0207] In some embodiments, the device 10 is controlled to provide
a minimum consecutive spot spacing of 1 mm. For example, the device
10 may controlled to provide a minimum consecutive spot spacing of
0.5 mm. In particular embodiments, the device 10 may controlled to
provide a minimum consecutive spot spacing of 0.25 mm.
[0208] In some embodiments, a pulse duration of between 1 ms and 10
ms may be selected. In certain embodiments, a pulse duration of
between 2 ms and 8 ms [smaller range] may be selected. In
particular embodiments, a pulse duration of between 3 ms and 6 ms
may be selected.
Some Example Embodiments and Example Operation Parameters
[0209] Any of the various features and configurations discussed
herein may be combined in any suitable manner, for providing a
variety of different treatments. Some example configurations with
example parameter values are provided below. It should be
understood that these are examples only.
[0210] Table 1 below shows example values and parameters for one
example embodiment of device 10 similar to the device shown in
FIGS. 4-7. In this example, to achieve 250 treatment spots/cm.sup.2
and a fractional coverage ratio of 2.5% with 8 mJ/treatment spot,
and the stated minimum coverage rate and duty factor, a 1.73 W
light source is pulsed at 30 Hz and the application end or "tip"
moved with a speed of 3.43 cm/s. The calculated blur factor caused
by the movement of the treatment tip 42 across the skin and other
parameters are also indicated.
TABLE-US-00001 TABLE 1 Pameter Example Target Value MTZ per cm2 250
treated skin (%) 2.5 area treated per MTZ (sq microns) 10000 spot
dia, no motion (microns) 113 energy per mtz (mJ) 8 fluence, no
motion (J/cm2) 80 min cov rate (cm2/min) 13 min cov rate (cm2/s)
0.22 min prf (hz) 30 max period (s) 0.0185 duty factor (%) 25 on
time (s) 0.0046 tip speed (cm/s) 3.43 actual area treated (microns)
27841 blur factor 2.8 actual fluence (J/cm2) 29 power (w) 1.73
[0211] Table 2 below shows example parameters and values for
another example embodiment of device 10 similar to the device shown
in FIGS. 4-7. A device with substantially these parameters has been
clinically tested on human subjects and animal models and shown to
produce desirable tissue response and clinical benefit, such as
texture improvement and reduction in pigmented lesions.
TABLE-US-00002 TABLE 2 Parameter Example Value Mechanical Size
(Length .times. Diameter) about 12 cm .times. about 1.7 cm (4.7 in.
.times. 0.7 in.) Weight 46 gr. Electrical: Battery (AA) LiFePO4
Batterty Life between recharges about 2 hrs Drive Current 7.6 A
Laser Diode Voltage 2.1 V Optical: Pulse Energy 14 mJ Pulse
Repetition Rate 10 Hz Pulse Width 3.3 ms Peak Power 4.24 W Average
Power 0.14 W Wavelength 1450 nm E/O efficiency 26.6%
[0212] Table 3 below shows example values and parameters for three
example configurations of an example device 10 similar to the
device shown in FIGS. 4-7. The table shows, for each of the three
example configurations, different optical power, pulse-on and
pulse-off times, treatment spot diameters, treatment tip
dimensions, and scan speeds. Resulting pulse rates, energy per
pulse, minimum scan speed for full coverage, illuminated area, blur
effect, fluency, and other parameters are also shown. Also shown
are calculations related to over-treatment protection where, in
this particular example, photobleaching is used to differentiate
treated and untreated areas. The treatment spot sizes and energies
can be obtained by direct-coupled edge emitting laser diode
emission (e.g., from one or more single-beam edge emitting laser
diode in close proximity to the skin with no intervening optics 16
(although a protective window may be provided) or by a fiber
delivered beam or by other suitable optical means. For example, an
edge emitting laser diode beam source of 500 micron chip size and
100 micron beam source size may be used to obtain the parameters
shown if placed in very close proximity to the skin.
TABLE-US-00003 TABLE 3 Example Example Example Parameter Config. 1
Config. 2 Config. 3 optical power (W) 4 7 7 on time of pulse (ms)
10 10 8 off-time of pulse (ms) 30 30 8 PRF (hz) 25 25 63 energy per
pulse (mJ) 40 70 56 spot diameter (microns) 150 220 150 square tip
dimension (microns) 625 625 625 min scan speed for full coverage
1.56 1.56 3.91 (cm/s) scan speed (cm/s) 0.50 2.00 3.91 illuminated
area per MTZ (mm2) 0.0252 0.0820 0.0646 blur (illum area/spot size)
1.4 2.2 3.7 Fluence per MTZ (J/cm2) 159 85 87 area treated per
second (mmw2) 0.63 2.05 4.04 area bleached per pulse (sq mm) 0.39
0.39 0.39 area bleached per second (mm2) 9.77 9.77 24.41 (area
treated)/(area bleached) 6% 21% 17% area bleached per minute (cm2)
5.86 5.86 14.65 area bleached per minute (in2) 0.91 0.91 2.27
[0213] Table 4 below shows example parameter values for a direct
exposure embodiment using a low fill-factor laser diode bar as the
radiation source 14B, operating in a gliding mode in which the
device is glided perpendicular to the elongated direction of the
laser diode bar 14B, with pulsed radiation for fractional
treatment. Each pulse of the laser diode bar 14B generates a linear
array of discrete, spaced-apart treatment spots 62, each
corresponding to one emitter 80 of the laser diode bar 14B, e.g.,
as discussed with respect to FIGS. 22A and 22B.
TABLE-US-00004 TABLE 4 Parameter Example value Specific example
Radiation source = laser diode bar Total optical efficiency (laser
diode 70%-90% about 80% bar to target) Proximity gap spacing 1
mm-10 mm about 1.5-2.5 mm Power emitted per emitter 1.3-9 W 2.4 W
total emitted by diode bar 50-80 W 70 W Pulse characteristics pulse
on-time 2-20 ms 6 ms duty cycle 10-60% 50% Length of instantaneous
irradiated 0.1-0.6 mm 0.2 mm area on target from single beam source
(perpendicular to elongated direction of diode bar) Width of
instantaneous irradiated 0.1-0.6 mm 0.3 mm area on target from
single beam source (parallel to elongated direction of diode bar)
Manual glide speed 2-6 cm/s 4 cm/s Total width of treatment spot 62
0.5-2 cm 1 cm pattern (parallel to elongated direction of diode
bar) Length of individual treatment spot 0.1-1 mm 0.3 mm 62
(perpendicular to elongated direction of diode bar) Area of
individual treatment spot 0.04-0.6 mm.sup.2 0.09 mm.sup.2 Width of
non-irradiated areas 150-800 .mu.m 300 .mu.m between individual
treatment spots 62 (parallel to elongated direction of diode bar)
Energy delivered per individual 2-100 mJ 12 mJ treatment spot
Length of non-irradiated areas 0.1-1.2 mm 0.25 mm between
successive treatment spot 62 patterns (perpendicular to elongated
direction of diode bar)
[0214] Single-Beam Edge Emitting Laser Diodes
[0215] As discussed above, in some embodiments, radiation source 14
is an edge emitting laser diode (or multiple edge emitting laser
diodes) including a single emitter (i.e., a single beam source)
that generates a single laser beam. In a typical edge emitting
laser diode, the emitted beam has a beam divergence of nearly
45.degree. in the fast axis direction and about 10.degree. in the
slow axis.
[0216] Due to the rapid divergence in the fast axis direction, the
laser diode bar provides a significant beam spread in this fast
axis direction, in the absence of optical elements provided
downstream of the laser diode bar. Therefore, in order to capture a
desired portion of the beam energy (and/or maintain a desired beam
intensity), certain embodiments are configured as "close proximity"
devices in which the "proximity gap spacing" is less than or equal
to 10 mm. As used herein, the "proximity gap spacing" or "PGS" is
defined as the distance between the emitting surface of the
radiation source (in this case, the edge emitting laser diode) and
the skin-contacting surface of device 10, i.e., the distance
between the emitting surface of the radiation source and the skin
during a treatment position of device 10 on the skin.
[0217] In some embodiments, the proximity gap spacing is less than
or equal to 5 mm, 2 mm, or even 1 mm. In particular embodiments,
the proximity gap spacing is less than 500 .mu.m, less than 200
.mu.m, or even less than 100 .mu.m. The proximity gap spacing may
be selected based on one or more parameters, e.g., the desired size
and/or intensity of treatment spots 62 delivered to the skin,
and/or manufacturing constraints or costs.
[0218] FIGS. 10-14 illustrate example direct exposure
configurations, which may further be configured for "close
proximity" radiation, depending on the proximity gap spacing or
"PGS" of the particular embodiment. Thus, in certain embodiments,
device 10 configured as shown in any of FIGS. 10-14 may have a
proximity gap spacing of less than or equal to 10 mm, 5 mm, 2 mm, 1
mm, 500 .mu.m, 200 .mu.m, or even 100 .mu.m in particular
configurations.
[0219] FIG. 10 illustrates a simplified cross-sectional side view
of an example embodiment of device 10 that includes an edge
emitting laser diode 14A including an emitter 80 having an emitting
surface 82. A transmissive window 44 (e.g., a sapphire or other
transmissive window, or a thin transmissive film) is located at the
application end 42 of device 10, and forms a skin-contacting
surface 74 with the skin 40. In some embodiments, manufacturing or
other limits may prevent the emitter 80 from being placed directly
onto the window 44, thus forming a gap between emitter 80 and
window 44. Thus, the proximity gap spacing (PGS) between the
emitting surface 82 of edge emitting laser diode 14A includes the
thickness of the window 44 (T.sub.w) plus the gap distance
(D.sub.G) between the emitting surface 82 and the window 44. In
other embodiments, emitter 80 or emitting surface 82 may be placed
directly onto the window 44, such that the gap distance (D.sub.G)
is effectively zero.
[0220] In some embodiments, window 44 has a thickness (T.sub.W) of
between about 100 .mu.m and about 200 .mu.m, with a gap distance
(D.sub.G) of about 50-150 .mu.m, providing in a proximity gap
spacing (PGS) of between about 150 .mu.m and about 350 .mu.m. In
other embodiments, window 44 is a thin film having a thickness of
less than 150 .mu.m, e.g., about 75 .mu.m, such that the proximity
gap spacing (PGS) may be about 125-225 .mu.m, depending on the gap
distance (D.sub.G).
[0221] In one example embodiment, window 44 is a sapphire window
with a thickness of about 140 .mu.m, with a gap distance of about
100 .mu.m, providing a proximity gap spacing (PGS) of about 240
.mu.m. At a proximity gap spacing of 240 .mu.m, an edge emitting
laser diode that emits a 1-micron by 95-micron beam with divergence
of 28 deg FWHM (fast axis) by 6 deg FWHM (slow axis), respectively,
will form an approximately circular treatment spot on the skin
having a diameter of about 120 .mu.m. With a device glide speed of
about 2 cm/s and a 5 ms pulse duration, the treatment spot becomes
an oval of about 120 .mu.m by 220 .mu.m in respective diameters. In
another example embodiment, window 44 is a sapphire window with a
thickness of about 180 .mu.m.
[0222] FIG. 11 illustrates an example configuration in which the
window 44 is set back from the skin by an offset distance
(D.sub.O), with another part of the treatment tip forming the
skin-contacting surface 74. Such offset may be provided for any
suitable reason, e.g., to protect the window from damage, to keep
the window clean, or to avoid friction between the window and the
skin. The proximity gap spacing (PGS) in this configuration is
composed of the thickness of the window 44 (T.sub.W), the gap
distance (D.sub.G) between the emitting surface 82 and the window
44, and the offset distance (D.sub.O) of the window 44.
[0223] FIG. 12 illustrates an example configuration that excludes a
window, such that the emitter 80 is exposed to open air. Thus, the
proximity gap spacing (PGS) may be set at any desired distance, or
even zero (i.e., with the emitting surface 82 touching the skin).
However, the edge emitting laser diode 14A may be set back from the
skin-contacting surface 74 by some distance, e.g., to protect the
edge emitting laser diode from damage, to keep the edge emitting
laser diode clean, to avoid friction between the edge emitting
laser diode and the skin, or to provide some distance for the beam
to diverge (in particular, in the fast axis direction) by a
suitable amount to form a suitable treatment spot size on the skin
or eye safety or other benefits.
[0224] FIG. 13 illustrates an example configuration that excludes a
window, but includes a film or other coating over the leading
surface of edge emitting laser diode 14A, e.g., to protect the edge
emitting laser diode from damage, provide electrical isolation, or
for other purposes. The proximity gap spacing (PGS) may be set at
any desired distance (limited only by the film thickness), or even
such that the film-covered emitting surface 82 touches the skin.
However, as discussed above regarding FIG. 12, the edge emitting
laser diode 14A may be set back from the skin-contacting surface 74
by some distance, e.g., to protect the edge emitting laser diode
from damage, to keep the edge emitting laser diode clean, to avoid
friction between the edge emitting laser diode and the skin, or to
provide some distance for the beam to diverge (in particular, in
the fast axis direction) by a suitable amount to form a suitable
treatment spot size on the skin.
[0225] FIG. 14 illustrates an example configuration of device 10
similar to the configuration of FIG. 10 but including two edge
emitting laser diodes 14A, each generating a discrete beam 60.
Device 10 may include any other number of edge emitting laser
diodes 14A, arranged in any suitable manner, e.g., in a row, a
two-dimensional array, or any other manner. Each edge emitting
laser diode 14A in device 10 may be arranged with the proximity gap
spacing between the respective emitter surface 82 and the
skin-contacting surface 74, or different edge emitting laser diodes
14A may be arranged to have different proximity gap spacing (PGS),
e.g., to provide multiple different treatment spot sizes, shapes,
or energy intensities at the skin. Two or more edge emitting laser
diodes 14A may similarly be arranged in any of the configurations
shown in FIGS. 10-13, as well as FIGS. 15-16 discussed below. Any
of these configurations may similarly utilize laser diode bars or
VCSELs with single beam or multiple beams, as discussed below.
[0226] FIGS. 15-16 illustrate example indirect exposure
configurations (i.e., including optics between the laser and the
skin), which may also be configured for "close proximity"
radiation, depending on the proximity gap spacing or "PGS" of the
particular embodiment. Thus, in certain embodiments, device 10
configured as shown in FIG. 15 or 16 may have a proximity gap
spacing of less than or equal to 10 mm, 5 mm, 2 mm, 1 mm, 500
.mu.m, 200 .mu.m, or even 100 .mu.m in particular
configurations.
[0227] FIG. 15 illustrates an example configuration of device 10
including a concave lens 78 positioned between edge emitting laser
diode emitter 80 and the skin. Convex lens 78 may act to increase
the divergence of the beam 60 in one or more axis (e.g., fast axis
and/or slow axis), e.g., to provide a desired spot size or shape,
and/or to provide increased eye safety. The lens 78 may be set back
from the skin-contacting surface 74, as shown in FIG. 15, or may
alternatively be arranged to contact the skin directly.
Alternatively, a convex lens could be used to decrease the
divergence of the beam 60 in one or more axis (e.g., fast axis
and/or slow axis), e.g., to provide a desired spot size or
shape.
[0228] FIG. 16 illustrates an example configuration similar to FIG.
15, but including a cylindrical lens or a ball lens 79 instead of
convex lens 78. Cylindrical or ball lens 79 may act to increase the
divergence of the beam 60 in one or more axis (e.g., fast axis
and/or slow axis), e.g., to provide a desired spot size or shape,
and/or to provide increased eye safety. Like lens 78 discussed
above, lens 79 may be set back from the skin-contacting surface 74,
or may alternatively be arranged to contact the skin directly, as
shown in FIG. 16.
[0229] In other embodiments, any other type of lens (e.g., aspheric
or other optic may be provided to affect the beam 60 as
desired.
[0230] FIGS. 17A-17C illustrate the asymmetrical divergence of a
beam 60 emitted from an edge emitting laser diode, in embodiments
in which the proximity gap spacing is extremely small. A typical
edge emitting laser diode includes an elongated rectangular emitter
80 having a long side and a short side. For example, an edge
emitting laser diode emitter 80 may be about 1 .mu.m by 100 .mu.m,
or about 5 .mu.m by 95 .mu.m.
[0231] FIG. 17A illustrates a long-side view of an edge emitting
laser diode emitter 80, and illustrates the relatively slow
divergence of the beam 60 in the slow axis. FIG. 17B illustrates a
short-side view of edge emitting laser diode emitter 80
(perpendicular to the long-side view), and illustrates the
relatively fast divergence of the beam 60 in the fast axis. FIG.
17C illustrates a top-down view showing edge emitting laser diode
emitter 80 and a corresponding treatment spot 62 formed by edge
emitting laser diode emitter 80, indicating the divergence of the
beam 60 in both the fast axis and slow axis to form a treatment
spot 62 having a generally oval or rounded-rectangular shape, which
is elongated in the slow-axis direction. A treatment spot 62
elongated in the slow-axis direction, such as shown in FIG. 17C,
may be produced by using an extremely small proximity gap spacing
(e.g., less than the slow-axis width of the laser diode emitter
surface or facet, e.g., about 100 .mu.m). FIG. 17C does not account
for any "smearing" or "blurring" of the treatment spot 62 due to
the movement of device 10 due to movement of device 10.
[0232] FIGS. 18A-18C are similar to FIGS. 17A-17C, but correspond
to configurations with a larger proximity gap spacing (e.g., about
500 .mu.m for an emitter surface or facet having a slow-axis width
of about 100 .mu.m), whereby the longer propagation of the
divergent beam 60 to the skin surface allows the fast axis
divergence to overcome the slow axis divergence. Thus, the
resulting treatment spot 62 may be elongated in the fast axis
direction, as shown in FIG. 18C. Like FIG. 17C, FIG. 18C does not
account for any "smearing" or "blurring" of the treatment spot 62
due to the movement of device 10 due to movement of device 10.
[0233] FIG. 19A illustrates a treatment spot 62 formed by edge
emitting laser diode emitter 80 emitting a beam pulse while device
10 is glided across the skin in the direction of the arrow, with
emitter 80 moving the dashed-line image of emitter 80 to the
solid-line image of emitter 80 during the pulse. Thus, the
illustration shows the "smearing" or "blurring" of the treatment
spot 62 due to the movement of device 10 during the beam pulse. In
this orientation, the device movement may smear or blur the
treatment spot 62 perpendicular to the elongated direction of the
instantaneous spot, by an amount that depends at least upon the
pulse duration and the manual glide speed. The longer the pulse
duration or the faster the manual glide speed, the greater the
elongation (blurring) of spot 62 in the glide direction. In the
example shown in shown in FIG. 19A, the amount of blurring produces
a generally circular or rounded-rectangular spot 62.
[0234] Like FIG. 19A, FIG. 19B illustrates a treatment spot 62
formed by edge emitting laser diode emitter 80 emitting a beam
pulse while device 10 is glided across the skin in the direction of
the arrow, with emitter 80 moving the dashed-line image of emitter
80 to the solid-line image of emitter 80 during the pulse. However,
in the example shown in FIG. 19B, the device is moved in the
elongated direction of the emitter 80, rather than perpendicular to
the elongated direction of the emitter 80 as shown in FIG. 19A.
Thus, the smearing or blurring of the treatment spot 62 caused by
the device movement may increase the elongation of the resulting
treatment spot 62.
[0235] Thus, it should be understood from the discussion above that
the exact shape and size of the resulting treatment spot 62 may
depend on a variety of factors, including at least (a) the size and
shape of the particular emitter 80, (b) the orientation of the
emitter 80 relative to the manual glide direction, (c) the
proximity gap spacing between the emitter surface 82 and the skin,
(d) the pulse duration, and (e) the manual glide speed. Any one or
more (or all) of parameters (a)-(d) may be selected or controlled
by device 10, and a desired manual glide speed may be encouraged
(e.g., by instructing the user) to provide treatment spots 62
having a desired shape and size.
[0236] FIG. 20 is a plot of a detected wavelength profile of laser
radiation received at a target surface from an example edge
emitting laser diode. In this example, the wavelength profile
defines an approximately Gaussian peak at 1450.4 nm.
[0237] FIGS. 21A and 21B illustrate example dimensions for a
treatment spot 62 and corresponding MTZ 64 generated by an edge
emitting laser diode configured for direct exposure and/or close
proximity radiation, e.g., according to any of the example
configurations of FIGS. 10-16. As shown in FIG. 21, an edge
emitting laser diode emitter 80 is positioned above the skin 40
with either a window 44 (i.e., not an optic 16), a lens 78 (i.e.,
an optic 16), or nothing (e.g., air only) positioned between the
emitting surface 82 and the skin 40. Depending on the particular
configuration, the proximity gap spacing (PGS) between the emitting
surface 82 of the edge emitting laser diode and the skin-contacting
surface of device 10 is indicated as PGS.sub.A (for embodiments in
which window 44 or lens 78 directly contacts the skin) or PGS.sub.B
(for embodiments in which window 44 or lens 78 is set back from the
skin by some distance). Where the proximity gap spacing is
indicated as PGS.sub.A (i.e., embodiments in which window 44 or
lens 78 directly contacts the skin), the PGS is equal to the
thickness of the window 44 or lens 78 (T.sub.w) plus the gap
distance (D.sub.G) between the emitting surface 82 and the window
44 or lens 78. As discussed above, in some embodiments emitter 80
may be placed directly onto the window 44 or lens 78, such that the
gap distance (D.sub.G) is effectively zero.
[0238] FIG. 21A also indicates the treatment spot 62 on the skin
surface, as well as the depth of the MTZ 64 extending below the
treatment spot 62, indicated as D.sub.MTZ.
[0239] FIG. 21B illustrates the dimensions of the treatment spot 62
on the skin surface, with the instantaneous treatment spot 62.sub.I
shown in solid line and the "blurred" treatment spot 62.sub.B (due
to gliding of device 10 across the skin during the delivery of the
beam pulse) shown in dashed line. The instantaneous treatment spot
62.sub.I is defined by a fast axis direction width W.sub.FA, a slow
axis direction width W.sub.SA.sub.--.sub.I, and an area A.sub.I.
The blurred treatment spot 62.sub.B is defined by a fast axis
direction width W.sub.FA, a slow axis direction width
W.sub.SA.sub.--.sub.B, and an area A.sub.B.
[0240] In some embodiments, one or more parameters of device 10 may
be selected or controlled to control or limit the amount of
blurring of treatments spots 62, e.g., to provide an effective spot
size and/or fluence or energy density at the skin within individual
treatments spots 62 (e.g., to achieve the desired dermatological
effect in the skin). For example, in some embodiments, one or more
of (a) the pulse duration and (b) the fluence or energy density of
the emitted beam 60 may be controlled or limited based on an
assumed manual glide speed (e.g., 2-6 cm/s), a measured manual
glide speed, or a measured displacement of device 10 across the
skin, for example, to limit the blurring of treatments spots 62 to
a defined maximum blur factor. As stated above, the blur factor may
be defined as the ratio of the area of the blurred treatment spot
62 (with blurring caused by movement of device 10) to the area of
the instantaneous treatment spot size. Thus, to illustrate, a blur
factor of 1.0 indicates no blurring, a blur factor of 2.0 indicates
a doubling of the treatment spot size area, and a blur factor of
3.0 indicates a tripling of the treatment spot size area.
[0241] In general, the larger the blur factor, the lower the
fluence or energy density at the skin within the area of the
blurred treatment spot. In some embodiments or device settings, a
blur factor of up to about 3.0 is generally acceptable for
providing effective MTZs for a fractional treatment. In other
embodiments or device settings, a blur factor of up to about 2.5 or
up to about 2.0 is generally acceptable for providing effective
MTZs for a fractional treatment. Thus, in some embodiments, one or
more device parameters (e.g., the pulse duration and/or the fluence
or energy density of emitted beams 60) may be selected controlled
to limit the blur factor to less than about 3.0, 2.5, or 2.0,
depending on the selected limit. Certain embodiments limit the blur
factor to less than about 1.8 or less than about 1.5. Other
embodiments or device settings may allow a blur factor of up to
about 3.5 or 4.0. Other embodiments or device settings may allow
even larger blur factors.
[0242] In some embodiments, the pulse duration may be limited to a
defined value (e.g., 5 ms) based on an assumed range of manual
glide speeds (e.g., 2-8 cm/s) to limit the blur factor to about
2.0. Further, it has been determined that an MTZ 64 need not be
circular or axis-symmetric in shape to be effective, and can be
elliptical or elongated to a certain extent, e.g., as caused by a
manual glide speed between about 6 cm/s and 10 cm/s for certain
embodiments.
[0243] Table 5 shows relevant parameter values for a variety of
example embodiments of device 10, with reference to FIGS. 21A and
21B.
TABLE-US-00005 TABLE 5 Specific Specific Example Example of Example
Example of Parameter Embodiment 1 Embodiment 1 Embodiment 2
Embodiment 2 Radiation Single beam Single beam Single beam Single
beam source edge emitting edge emitting laser diode laser diode
laser diode laser diode emitter surface 100 (slow- 100 (slow- 100
(slow- 100 (slow- (.mu.m .times. .mu.m) axis) .times. 5 (fast-
axis) .times. 5 (fast- axis) .times. 5 (fast- axis) .times. 5
(fast- axis) axis) axis) axis) window or window window window
window lens? beam 35.degree.-45.degree. fast 45.degree. fast axis
35.degree.-45.degree. fast 45.degree. fast axis divergence at axis,
10.degree. slow axis axis, 10.degree. slow axis skin surface
6.degree.-12.degree. slow 6.degree.-12.degree. slow (fast axis,
slow axis) axis axis T.sub.W (.mu.m) 150-250 180 50-150 130 D.sub.G
(.mu.m) 200-500 320 50-150 130 PGS (.mu.m) 350-750 500 100-300 260
W.sub.FA (.mu.m) 225-625 419 70-255 220 W.sub.SA.sub.--.sub.I
(.mu.m) 135-260 187 110-165 145 A.sub.I (mm.sup.2) 0.03-0.16 0.078
0.01-0.04 0.032 manual glide 2-6 4 1-4 2 speed (cm/s)
W.sub.SA.sub.--.sub.B (.mu.m) 155-740 307 (W.sub.SA.sub.--.sub.B;
120-765 225 (W.sub.SA.sub.--.sub.B; glide in slow- glide in slow-
axis direction) axis direction) A.sub.B (mm.sup.2) 0.03-0.46 0.129
0.01-0.20 0.050 Pulse duration 1-8 3 1-15 4 (ms) Power (W) 2-6 4
1-4 3 Total energy 5-15 12 5-15 12 per pulse (mJ) Energy density
1.1-50 9.3 2.5-150 24 (J/cm.sup.2) D.sub.MTZ (.mu.m) 100-400 260
120-700 350 Pulse 10-30 15 10-40 20 frequency rate (Hz) Specific
Specific Example Example of Example Example of Parameter Embodiment
3 Embodiment 3 Embodiment 4 Embodiment 4 Radiation Single beam
Single beam Single beam Single beam source laser diode laser diode
laser diode laser diode emitter surface 100 (slow- 100 (slow- 100
(slow- 100 (slow- (.mu.m .times. .mu.m) axis) .times. 5 (fast-
axis) .times. 5 (fast- axis) .times. 5 (fast- axis) .times. 5
(fast- axis) axis) axis) axis) window or convex rod convex rod
neither (air) neither (air) lens? lens lens beam
2.degree.-8.degree. fast axis 5.degree. fast axis
35.degree.-45.degree. fast 45.degree. fast axis divergence at
6.degree.-12.degree. slow 10.degree. slow axis axis, 10.degree.
slow axis skin surface axis 6.degree.-12.degree. slow (fast axis,
slow axis) axis T.sub.W (.mu.m) 50-150 130 N/A N/A D.sub.G (.mu.m)
400-2500 2000 50-150 100 PGS (.mu.m) 450-3000 2130 50-150 100
W.sub.FA (.mu.m) 20-425 191 35-130 88 W.sub.SA.sub.--.sub.I (.mu.m)
145-730 473 105-130 117 A.sub.I (mm.sup.2) 0.003-0.31 0.090
0.004-0.02 0.010 manual glide 2-6 4 1-4 2 speed (cm/s)
W.sub.SA.sub.--.sub.B (.mu.m) 40-900 351 (W.sub.FA.sub.--.sub.B;
45-450 168 (W.sub.FA.sub.--.sub.B; glide in fast- glide in fast-
axis direction) axis direction) A.sub.B (mm.sup.2) 0.006-0.66 0.166
0.005-0.06 0.020 Pulse duration 1-8 4 1-8 4 (ms) Power (W) 2-6 3
2-6 3 Total energy 5-15 12 5-15 12 per pulse (mJ) Energy density
0.8-250 7.2 8-300 60 (J/cm.sup.2) D.sub.MTZ (.mu.m) 100-700 250
250-700 450 Pulse 10-30 15 10-40 30 frequency rate (Hz)
Laser Diode Bars
[0244] As discussed above, in some embodiments, radiation source 14
is an laser diode bar (or multiple laser diode bars) including
multiple emitters, each acting as a discrete beam source that
generates a discrete laser beam. In a typical laser diode bar, the
beam emitted from each beam source (emitter) of the laser diode bar
has a beam divergence of nearly 45.degree. in the fast axis
direction and about 10.degree. in the slow axis.
[0245] Due to the rapid divergence in the fast axis direction, the
laser diode bar provides a significant beam spread in this fast
axis direction, in the absence of optical elements provided
downstream of the laser diode bar. Therefore, as with an edge
emitting laser diode, in order to capture a desired portion of the
beam energy (and/or maintain a desired beam intensity), certain
embodiments are configured as close proximity devices in which the
proximity gap spacing (the spacing between emitting surfaces of the
laser diode bar and the skin-contacting surface 74 of device 10) is
less than or equal to 10 mm. In certain laser diode bar
embodiments, device 10 may have a proximity gap spacing of less
than or equal to 5 mm, 2 mm, 1 mm, 500 .mu.m, 200 .mu.m, or even
100 .mu.m, depending on the desired size and/or intensity of the
treatment spots 62 generated by the laser diode bar.
[0246] The multiple beams emitted by the multiple emitters of an
laser diode bar may (a) remain separate during their propagation to
the skin to form multiple, spaced-apart treatment spots 62 on the
surface of the skin, or (b) partially or substantially combine
during their propagation to the skin (due to the divergence of the
individual beams) to form a single contiguous treatment spot 62
with substantially uniform or spatially modulated energy profile,
depending at least on (a) the proximity gap spacing between the
emitting surfaces of the laser diode bar and the skin, (b) the size
and shape of each emitter of the laser diode bar, and (c) the fill
factor of the laser diode bar.
[0247] FIGS. 22A-23B illustrate example embodiments in which the
multiple beams emitted by the multiple emitters of an laser diode
bar remain separate and form multiple, spaced-apart treatment spots
62 on the skin. Such embodiments may be suitable or advantageous
for certain applications or treatments, e.g., certain fractional
treatments. In contrast, FIGS. 24A-24B illustrate an example
embodiment in which the multiple beams emitted by the multiple
emitters of an laser diode bar combine during their propagation to
the skin (due to the divergence of the individual beams) to form a
single contiguous treatment spot 62. In particular, the example
embodiment of FIGS. 24A-24B includes a "high fill-factor" laser
diode bar that promotes the combination of the individual beams to
form a single contiguous treatment spot 62 on the skin. Such
embodiments may be suitable or advantageous for certain
applications or treatments, e.g., hair removal treatments, bulk
heating for skin tightening, or acne, for example, or non-ablative
wrinkle treatments.
[0248] Turning first to FIGS. 22A-23B, FIG. 22A illustrates a
simplified cross-sectional side view of an embodiment similar to
the embodiment of FIG. 10, but including an laser diode bar 14B
instead of a single-emitter edge emitting laser diode 14A as the
radiation source. Laser diode bar 14B includes multiple emitters 80
arranged in a row, with each emitter 80 acting as a discrete beam
source that generates a discrete laser beam 60. The multiple beams
60 emitted by the multiple emitters 80 of the laser diode bar 14B
form a linear array of spaced-apart treatment spots 62 on the skin,
and thus a corresponding linear array of spaced-apart MTZs 64 in
the skin. This embodiments may be suitable for fractional
treatment, for example. Laser diode bar 14B may include any
suitable number of emitters 80.
[0249] Laser diode bar 14B may be controlled to deliver pulsed
radiation, continuous wave (CW) radiation, or otherwise. FIG. 22B
shows a two-dimensional array of treatment spots 62 formed by
manually scanning an array of beams 30 onto the skin, e.g., by
pulsing laser diode bar 14B while device 10 is moved across the
skin in the indicated direction, e.g., in a gliding mode or
stamping mode operation. Each pulse of the laser diode bar 14B
generates a linear array 66 of treatment spots 62, such that moving
device 10 in a direction generally perpendicular to the linear
array 66 provided by each pulse creates a two-dimensional array 68
of treatment spots 62. Device 10 may be glided across the skin any
suitable number of times and in any suitable direction(s) to cover
a desired treatment area.
[0250] FIG. 23A illustrates a partial three-dimensional view of
laser diode bars 14B and a window 44 for an embodiment of device 10
including multiple laser diode bars 14B arranged parallel to each
other (e.g., to form a "stack"). Each emitter 80 of each laser
diode bar 14B may act as a discrete beam source that generates a
discrete laser beam 60, with the multiple beams 60 of the multiple
laser diode bars 14B forming a two-dimensional array of
spaced-apart treatment spots 62 on the skin, and thus a
corresponding linear array of spaced-apart MTZs 64 in the skin.
[0251] As discussed above, laser diode bars 14B may be controlled
to deliver pulsed radiation, continuous wave (CW) radiation, or
otherwise. In a pulsed embodiment, the multiple laser diode bars
14B may be pulsed simultaneously, time-sequentially in any defined
order (or in random order), or in any other manner. FIG. 23B shows
a two-dimensional array of treatment spots 62 formed by manually
scanning an array of beams 30 onto the skin, e.g., by pulsing laser
diode bars 14B while device 10 is moved across the skin in the
indicated direction, e.g., in a gliding mode or stamping mode
operation. In this example, the multiple laser diode bars 14B are
pulsed simultaneously. Thus, each pulse of the laser diode bar 14B
generates a two-dimensional array 67 of treatment spots 62, and the
combination of moving device 10 and pulsing the multiple laser
diode bars 14B creates a larger two-dimensional array 68 of
treatment spots 62 extending in the direction of the device
movement. Device 10 may be glided across the skin any suitable
number of times and in any suitable direction(s) to cover a desired
treatment area.
[0252] The example embodiments of FIGS. 22A-23B may utilize "low
fill-factor" laser diode bars that provide sufficient spacing
between adjacent emitters 80 for providing the resulting
spaced-apart treatment spots 62 on the skin. In contrast, FIGS.
24A-24B include a "high fill-factor" laser diode bar that promotes
the combination of the individual beams to form a single contiguous
treatment spot 62 on the skin. In particular, the multiple beams
emitted by the multiple emitters of the high fill-factor laser
diode bar may combine during their propagation to the skin (due to
the divergence of the individual beams) to form a single contiguous
treatment spot 62.
[0253] As used herein, "high fill-factor" means a fill-factor of at
least 50%, as compared to a "low-fill factor," defined as a
fill-factor of less than 50%. The fill factor is defined as the
total emitter active portion of the laser diode bar divided by the
width of the entire laser diode bar, as defined in greater detail
in co-pending U.S. Provisional Patent Application 61/563,491, the
entire contents of which are hereby incorporated by reference. For
some applications, using high fill-factor laser diode bars may
provide one or more advantages as compared to low fill-factor laser
diode bars. For example, a high fill-factor laser bar may provide a
more uniform radiation image at the target surface. The beam
profile from the high fill-factor, laser diode bar, even in certain
close proximity arrangements, is a substantially uniform line
segment. Such uniform line segment may be suitable or desirable for
certain applications or treatments, e.g., a gliding treatment
normal to the line segment direction (e.g., for laser hair removal,
bulk heating skin tightening, or other suitable treatments). In
some embodiments, the high fill-factor laser diode bar may be used
in conjunction with a sensor (e.g., a displacement sensor or a
motion/speed sensor) to allow a treatment dose to be metered
uniformly over a relatively large area.
[0254] FIG. 24A illustrates an embodiment similar to that of FIG.
22A, but using a high fill-factor laser diode bar 14C. As shown,
the beams 60 emitted by the multiple emitters 80 of the laser diode
bar 14C combine with each other during their propagation to the
skin to form a single contiguous treatment spot 62, and a
corresponding single contiguous MTZ 64. FIG. 24B illustrates an
example contiguous treatment spot 62 generated by laser diode bar
14C. Laser diode bar 14C may be pulsed, may provide continuous wave
(CW) radiation, or may be otherwise controlled, in combination with
movement of device 10 across the skin (e.g., in a gliding mode or
stamping mode operation) to provide the desired size, shape, and
pattern of treatment spots 62 suitable for the particular
dermatological treatment, e.g., as described in more detail in
incorporated co-pending U.S. Provisional Patent Application
61/563,491.
[0255] As discussed above, in some embodiments of device 10, laser
diode bars (e.g., laser diode bars 14B/14C) may be configured for
"direct exposure" radiation, "close proximity" radiation, or both,
as such terms are defined and discussed herein. Further, laser
diode bars may be arranged in any of the various configurations
discussed herein regarding other types of radiation sources, e.g.,
laser diode bars may be arranged in any of the various
configurations shown in FIGS. 10-16 with respect to embodiments
including edge emitting laser diodes.
[0256] FIGS. 25 and 26 illustrate an example embodiment of device
10 in which the radiation source 14 is laser diode bar including an
array of 19 laser emitters 80 that emit an array of beams 60 to
generate an array of treatment spots 62 in a single pulse. The
device can be constructed as a fully solid-state device with no
optics or moving parts. Because the laser diode bar generates
multiple treatment spots 62 in each pulse, the device may achieve
faster treatment rate and may be less expensive per spot relative
to a device using a single-emitter laser diode and/or may deliver a
preferred dot pattern, such as more uniform spacing or reduced
blurring or smearing of the spots, when manually moved across the
skin.
VCSEL Lasers
[0257] As discussed above, in some embodiments, device 10 includes
one or more VCSEL (Vertical Cavity Surface Emitting Laser) lasers
for generating one or more treatment beams, A VCSEL may be
configured to generate a single energy beam (e.g., as shown in
FIGS. 27-29) or multiple discrete energy beams (e.g., as shown in
FIGS. 30-34). In some embodiments, a VCSEL can be configured to
generate an array (1D or 2D) of discrete laser beams for creating
an array (1D or 2D) of spaced-apart treatment spots 62 on the skin,
e.g., to provide a fractional treatment.
[0258] FIG. 27 illustrates a simplified cross-sectional side view
of an example embodiment of device 10 that includes a VCSEL 14D
configured to generate a single energy beam for providing a single
treatment spot 62 on the skin. VCSEL 14D may include an array 84 of
micro-emitters 86, as shown in FIG. 29, which shows an emitter
surface view of the example VCSEL 14D in the direction of arrow 28
shown in FIG. 27. Each micro-emitter 86 emits a divergent
micro-beam, and the array of micro-beams combine (due to the
divergence of the individual micro-beams) to form a single,
generally uniform beam 60 for delivery to the skin, as shown in
FIG. 27. Thus, in such embodiments, the micro-emitter array 84 acts
as a single beam source to generate a single beam 60 that creates a
single treatment spot 62 on the skin.
[0259] For at least some VCSELs, each micro-emitter 86 emits a
circularly symmetrical micro-beam. For example, each micro-emitter
86 may emit a micro-beam having an axially-symmetric divergence
angle of above 20.degree. (e.g., conventional VCSELs), or a
divergence angle of between 10.degree. and 20.degree. (e.g.,
certain surface relief and antiresonant reflecting optical
waveguide structures), or a divergence angle of between 7.degree.
and 10.degree., or a divergence angle of below 7.degree. (e.g.,
certain holey structures, such as photonic crystals and multi-leaf
structures), or a divergence angle of about 6.degree. (e.g.,
certain multi-leaf VCSELs), or a divergence angle of below
6.degree., e.g., between 5.1.degree. and 5.5.degree. (for certain
photonic crystal vertical-cavity surface-emitting laser
(PC-VCSEL)), e.g., as described in "Reduction of the Far-Field
Divergence Angle of an 850 nm Multi-Leaf Holey Vertical Cavity
Surface Emitting Laser," Zhou Kang et al., CHIN. PHYS. LETT. Vol.
28, No. 8 (2011) 084209; and "Reduced divergence angle of photonic
crystal vertical-cavity surface-emitting laser," Anjin Liu et al.,
Appl. Phys. Lett. 94, 191105 (2009); doi:10.1063/1.3136859.
[0260] Micro-emitter array 84 may have any suitable shape, size,
and configuration, and may include any suitable number of
micro-emitters 86 arranged in any suitable pattern to form any
suitable one-dimensional or two-dimensional array 84. For example,
the micro-emitters 86 in an array 84 may be evenly spaced from each
other, e.g., to provide a beam 60 having a generally uniform
intensity profile, or may be unevenly spaced from each other, e.g.,
to provide a beam 60 having a selected non-uniform intensity
profile suitable for a particular application or treatment. For
example, micro-emitters 86 towards the outside of the array 84 may
be spaced further apart from each other to provide a more rounded
(i.e., less flat-topped or top hat-like) beam intensity profile,
which may be suitable for particular applications or treatments. As
another example, micro-emitters 86 towards the inside of the array
84 may be spaced further apart from each other to provide a more
cusped beam intensity profile having a dip in intensity level near
the center of the profile, which may be suitable for particular
applications or treatments. Similarly, the emitters could be
distributed to produce a flat-topped or Gaussian beam profile.
Micro-emitters 86 may be arranged in any other suitable manner to
provide any other desired beam intensity profile.
[0261] FIG. 29 illustrates a simplified cross-sectional side view
of an example embodiment of device 10 that includes a
single-beam-source VCSEL 14D (e.g., as discussed above regarding
FIGS. 27-28) and an optic 78 downstream of the VCSEL. Optic 78 may
be any type of lens (e.g., concave, convex, ball lens, cylindrical
lens, aspherical lens, etc.) or other optic for affecting the
radiation emitted by VCSEL 14D as desired. For example, optic 78
may be provided e.g., to increase or decrease the divergence of the
resulting beam 60 delivered to the skin, such as to provide a
desired spot size or shape, energy intensity level at the skin,
and/or to provide increased eye safety. The downstream optic(s) may
be provided directly on the VCSEL(s) via coatings, MEMs structures
or otherwise, so may be monolithic with the VCSEL(s). Other optics
examples are a microlens array, fiber(s), or fiber bundles, among
others.
[0262] FIGS. 30-34 illustrate embodiments that include a VCSEL
configured to generate an array (1D or 2D) of multiple discrete
laser beams for creating an array (1D or 2D) of multiple
spaced-apart treatment spots 62 on the skin, e.g., to provide a
fractional treatment. FIG. 30 illustrates an emitter surface view
of an example VCSEL 14D in which micro-emitters 86 are arranged in
an array (in this example, a 3.times.3 two-dimensional array) of
discrete micro-emitter zones 88, each including a number of
micro-emitters 86. Each micro-emitter zone 88 acts as a single beam
source to provide a single discrete beam 60 for delivery to the
skin. In particular, the micro-beams emitted by the micro-emitters
86 in each particular zone 88 combine (due to the divergence of the
individual micro-beams) to form a single, discrete beam 60. Thus,
the 3.times.3 array of discrete spaced-apart micro-emitter zones 88
forms a 3.times.3 array of discrete beam sources that generate a
3.times.3 array of discrete spaced-apart beams 60, which provide a
corresponding 3.times.3 array of discrete spaced-apart treatment
spots 62 on the skin, e.g., for providing a fractional
treatment.
[0263] The micro-emitter zones 88 may be separated from each by
non-active regions of the VCSEL chip, which regions may be formed
by known photolithographic techniques. Each micro-emitter zone 88
may have any shape and size, and may include any number of
micro-emitters 86 arranged in any suitable pattern to form any
suitable one-dimensional or two-dimensional array of micro-emitters
86. For example, in some embodiments in which VCSEL is configured
for pulsed radiation, each zone 88 may be shaped to provide a
desired treatment spot size and/or shape, taking into consideration
an assumed rate of movement of the device 10 across the skin during
the pulsed radiation. Thus, for instance, to provide treatment
spots 62 having a generally symmetrical shape (e.g., generally
circular or square), each zone 88 may be elongated in the direction
perpendicular to the expected glide direction of the device 10,
with the aspect ratio of such elongation being selected based on an
expected glide speed or range of glide speeds of the device 10. The
zones may also be created by masking certain regions, such as by
overlaying an opaque material, or by using optics, such as
microlens array, or any other suitable means. As with uniform
VCSELs, optics may be monolithic to the VCSEL and built with
coatings, such as spun-on-glass, or MEMs, or other means.
[0264] Further, as discussed above regarding the single-beam-source
VCSEL, the micro-emitters 86 in an array 84 may be evenly spaced
from each other, e.g., to provide a beam 60 having a generally
uniform intensity profile, or may be unevenly spaced from each
other, e.g., to provide a beam 60 having a selected non-uniform
intensity profile suitable for a particular application or
treatment.
[0265] In addition, VCSEL 14D may include any suitable number of
micro-emitter zones 88 arranged in any suitable pattern to form any
suitable one-dimensional or two-dimensional array of zones 88.
Zones 88 may evenly spaced from each other, e.g., to provide a
generally uniform array of beams 60, or may be unevenly spaced from
each other, e.g., to provide a non-uniform array of beams 60 for a
particular application or treatment.
[0266] FIG. 31 a simplified cross-sectional side view of an example
embodiment of device 10 that includes the example multi-beam-source
VCSEL 14D of FIG. 30. In particular, the figure shows one row of
the 3.times.3 array of micro-emitter zones 88, which row generates
three discrete, spaced-apart beams 60 for delivery to the skin.
[0267] FIG. 32 illustrates an example array of treatment spots 62
generated by the example VCSEL 14D shown in FIG. 30, e.g., as
arranged in a device 10 as shown in FIG. 31. FIG. 33 illustrates an
example one-dimensional array of treatment spots 62 generated by
another example VCSEL having a one-dimensional array of (in this
example, four) micro-emitter zones 88. As discussed above, VCSEL
14D may be configured to provide any other suitable one-dimensional
or two-dimensional array of treatment spots 62 by designing
micro-emitter zones 88 as desired.
[0268] FIG. 34 a simplified cross-sectional side view of an example
embodiment of device 10 that includes a multi-beam-source VCSEL 14D
(e.g., the VCSEL shown in FIG. 30), with a micro-lens array 79 for
affecting each beam 60 generated by the various micro-emitter zones
88. Micro-lens array 79 may include an array of optical elements
corresponding to the array of micro-emitter zones 88 of the
particular VCSEL 14D, with each optical element of the array
corresponding to one zone 88 of VCSEL 14D (and thus one beam 60).
The optical elements of the micro-lens array 79 may be discrete
elements or may be formed as a contiguous structure, e.g., as shown
in FIG. 34. Each optical element of the array 79 may comprise any
type of lens (e.g., concave, convex, ball lens, cylindrical lens,
aspherical lens, etc.) or other optic for affecting the
corresponding beam 60 as desired. For example, each optical element
of array 79 may be provided to increase or decrease the divergence
of the resulting beam 60 delivered to the skin, such as to provide
a desired spot size or shape, energy intensity level at the skin,
and/or to provide increased eye safety.
[0269] In some embodiments, each micro-emitter zone 88 of a
multi-beam-source VCSEL may be independently addressable or
controllable, e.g., by independently controlling the current
applied to each micro-emitter zone 88. For example, zones 88 may be
independently turned on/off or pulsed, or activated at different
power levels. For pulsed embodiments, the various pulsing
parameters for each zone 88, e.g., pulse on time, pulse off time,
pulse frequency, pulse duration, pulse profile, intensity, power
level, etc., may be controlled independent of the other zones 88.
Thus, for instance, the multiple zones 88 may be controlled to
deliver pulsed beams 60 (and create corresponding treatment spots
62) in any spatial or sequential order, e.g., according to a
defined algorithm, semi-randomly, or randomly.
[0270] In some embodiments, device 10 may include a single VCSEL
for providing one or multiple beams 60, as discussed above. In
other embodiments, device 10 may include multiple VCSELs, each
providing one or multiple beams 60. Multiple VCSELs may be arranged
in any suitable manner in device 10, e.g., in any suitable
one-dimensional or two-dimensional array.
[0271] In some embodiments of device 10, VCSEL(s) may be configured
for "direct exposure" radiation, "close proximity" radiation, or
both, as such terms are defined and discussed herein. Further,
VCSEL(s) may be arranged in any of the various configurations
discussed herein regarding other types of radiation sources, e.g.,
VCSEL(s) may be arranged in any of the various configurations shown
in FIGS. 10-16 with respect to embodiments including edge emitting
laser diodes or configured with sensors, such as displacement,
velocity, or contact, or configured for eye safety, such as Class
1M or better per IEC 60825, and other features disclosed herein.
Some embodiments that use VCSEL(s) as radiation source(s) may
include a diffuser or other element(s) or configuration to increase
the eye safety aspects of such devices, e.g., depending on the beam
divergence of the particular VCSELs, the configuration of
micro-emitters 86 and emitter zones 88, and/or one or more
operational parameters of device 10, e.g., pulse parameters, output
fluence, etc.
[0272] Like edge emitting laser diodes 14A and laser diode bars
14B/14C discussed above, VCSELs 14D may be controlled to deliver
pulsed radiation, continuous wave (CW) radiation, or otherwise.
Thus, embodiments of device 10 including one or more VCSELs can
generate one- or two-dimensional arrays of treatment spots 62 by
manually scanning a series of beams 30 onto the skin, e.g., by
pulsing the VCSEL(s), or the individual micro-emitter zones 88 of
the VCSEL(s) while device 10 is moved across the skin, e.g., in a
gliding mode or stamping mode operation. The device 10 may be
glided across the skin any suitable number of times and in any
suitable direction(s) to cover a desired treatment area.
Eye Safety
[0273] Some embodiments of device 10 provide eye safe radiation, by
delivering a substantially divergent energy beam 60 (e.g., using an
edge emitting laser diode with no downstream optics), and/or using
an eye safety control system including one or more sensors 26,
and/or by any other suitable manner. For example, in some
laser-based embodiments or settings (including certain direct
exposure embodiments and certain direct exposure embodiments),
device 10 meets the Class 1M or better (such as Class 1) eye safety
classification per the IEC 60825-1, referred to herein as "Level 1
eye safety" for convenience. In other laser-based embodiments or
settings (including certain direct exposure embodiments and certain
direct exposure embodiments), the device falls outside the IEC
60825-1 Class 1M eye safety classification by less than 25% of the
difference to the next classification threshold, referred to herein
as "Level 2 eye safety" for convenience. In still other laser-based
embodiments or settings (including certain direct exposure
embodiments and certain direct exposure embodiments), the device
falls outside the IEC 60825-1 Class 1M eye safety classification by
less than 50% of the difference to the next classification
threshold, referred to herein as "Level 3 eye safety" for
convenience. In some lamp-based embodiments, the device meets the
"Exempt" or "Low Risk" eye safety classification per the IEC
62471.
[0274] Some laser-based embodiments of device 10 configured for
direct exposure (and/or close proximity exposure) of laser
radiation provide Level 3 eye safety as defined above; some
laser-based direct exposure embodiments provide Level 2 eye safety
as defined above; and some laser-based direct exposure embodiments
provide Level 1 eye safety as defined above. Some laser-based
embodiments of device 10 configured for indirect exposure (and/or
close proximity exposure) of laser radiation provide Level 3 eye
safety as defined above; some laser-based direct exposure
embodiments provide Level 2 eye safety as defined above; and some
laser-based direct exposure embodiments provide Level 1 eye safety
as defined above.
[0275] Such levels of eye safety may be provided based on a
combination of factors, including for example, (a) the divergence
of the beam, (b) the pulse duration, (c) the emitted power, (d) the
total energy per pulse, (e) the wavelength of the emitted beam,
and/or (f) the arrangement of the laser beam source. Thus, in some
embodiments (including certain direct exposure, close proximity
embodiments; certain direct exposure, remote proximity embodiments;
certain indirect exposure, close proximity embodiments; and certain
indirect exposure, remote proximity embodiments), one, some, or all
of such factors may be selected or adjusted to provide Level 1,
Level 2, or Level 3 eye safety, as defined above.
[0276] Certain beam sources discussed herein generate divergent
(and in some cases, highly divergent) radiation in at least one
axis, which may increase the eye safety aspect of embodiments that
employ such beam sources. For example, a typical edge emitting
laser diode diverges in both a fast axis and a slow axis, which may
to provide Level 1, Level 2, or Level 3 eye safety, depending on
the other selected parameters. An analysis of relevant issues is
discussed below.
[0277] Highly divergent intense light source can be eye safe if it
meets the IEC 60825-1 Class 1M AEL (Accessible Emission Limit)
specification. With Class 1M classification, the source is
generally only potentially harmful if an intervening optics is
deliberately placed in between the source and the eye. For the
typical wavelength greater than 1400 nm used in fractional laser
treatment, the light source is also greatly attenuated by the water
absorption in the eye anterior chamber. Hence there is
substantially little or no retinal hazard in this wavelength range.
The emission limit is determined by the potential corneal damage.
The accessible emission limit for Class 1M source in the wavelength
range of 1400 to 1500 nm and 1800 to 2600 nm is described by a
simple equation in Table 4 of IEC 60825-1:2007:
AEL=4.4t.sup.0.25 mJ Equation 1
[0278] AEL energy is measured at 70 mm from the source with a
circular aperture of 7 mm in diameter (Condition 2 measurement
setup described in Table 11 of IEC 60825-1:2007, applicable for
diverging beam). In this equation, t (in unit of seconds) is the
source pulse duration in the range of 1 ms to 350 ms. For a typical
single beam laser diode source, this pulse duration is in the range
of 1 to 10 ms. Therefore, the corresponding AEL is 0.8 to 1.4
mJ.
[0279] The actual source AE (Accessible Energy) can be estimated
for a given beam divergent characteristics. It can also be measured
experimentally with the appropriate aperture stop (7-mm wide) and
measurement distance (70-mm from the source). The AE at a distance
70-mm from the treatment aperture is given by (this is
approximately correct for a Gaussian beam from a diffraction
limited laser):
AE=2.5.times.10.sup.-3Q/[tan (.PHI..sub.F/2) tan (.PHI..sub.S/2)]mJ
Equation 2
[0280] where Q (in unit of mJ) is the source energy at the
treatment plane, and .PHI..sub.F and .PHI..sub.S are the beam
divergence in the fast and slow axis, respectively. To achieve the
Class 1M eye safety classification, AE must be lower than the AEL
for the corresponding pulse duration.
[0281] Table 6 below provides several example configurations and
device settings for providing Level 1 eye safety (Class 1M or
better per standard IEC 60825-1) for certain embodiments of device
10,
TABLE-US-00006 TABLE 6 Specific Specific Example Example of Example
Example of Parameter Embodiment 1 Embodiment 1 Embodiment 2
Embodiment 2 Configuration direct exposure direct exposure indirect
indirect (no optics) (no optics) exposure (with exposure (with
optic) optic) Radiation Single beam Single beam Single beam Single
beam source edge emitting edge emitting edge emitting edge emitting
laser diode laser diode laser diode laser diode w/ w/collimating
collimating optics optics wavelength 1400-1500 nm 1400-1500 nm
1400-1500 nm 1400-1500 nm or 1800-2600 nm or 1800-2600 nm or
1800-2600 nm or 1800-2600 nm beam 35.degree.-45.degree. fast
45.degree. fast axis 2.degree.-12.degree. fast 12.degree. fast axis
divergence at axis, 10.degree. slow axis axis, 12.degree. slow axis
skin surface 6.degree.-12.degree. slow 6.degree.-12.degree. slow
(fast axis, slow axis axis axis) Pulse duration 1-8 about 3 1-15
about 5 (ms) Power (W) 2-6 about 4 1-4 about 1 Total energy 5-15
about 12 5-15 about 5 per pulse (mJ) AEL (mJ) 0.8-1.3 about 1.0
0.8-1.5 about 1.2 AE (mJ) 0.3-2.3 about 0.8 1.1-41 about 1.1 Eye
safety Class 1M for Class 1M Class 1M for Class 1M classification
AE < AEL AE < AEL
[0282] Because certain embodiments or device settings may provide
Level 1, Level 2, or Level 3 eye safety based on the appropriate
selection of parameters discussed above, in some such embodiments
an eye safety sensor or system may be omitted. However, some such
embodiments, even those providing Level 1 eye safety, may include
an eye safety sensor or system to provide redundancy, to meet
particular regulatory standards, or for other reasons.
[0283] In at least some embodiments additional eye safety is
provided by incorporating a contact sensor that enables pulsing of
the light source only when in contact with the skin. Thus, in such
embodiments, the likelihood of corneal eye injury may be reduced or
substantially eliminated unless the device is literally pressed to
the eye surface.
[0284] Some embodiments may include an optical diffuser or
radiation-diffusing elements or configuration (e.g., as described
in U.S. Pat. No. 7,250,045, U.S. Pat. No. 7,452,356, or US Patent
Application Publication, all three of which are hereby incorporated
by reference), one or more optics (e.g., a lens), or other elements
and configurations (e.g., selected pulse durations, wavelengths,
pulse repetition frequencies, beam profile characteristics, and
beam propagation characteristics) to provide increased eye safety.
Other embodiments may provide a particular eye safety level (e.g.,
Level 1, Level 2, or Level 3 as defined above) without such
elements, and in a direct exposure configuration (and/or close
proximity configuration), due to the inherent or selected
divergence of the beam source (e.g., certain laser diodes) combined
with suitable operational parameters of the beam source, e.g., as
discussed above.
Displacement-Based Control
[0285] As discussed above regarding FIG. 1, device 10 may include
control systems 18 configured to control various controllable
operational parameters of device 10 (e.g., operational aspects of
radiation engine 12, fans 34, displays 32, etc.). In some
embodiments, control systems 18 may include a displacement
monitoring and control system 132 ("displacement-based control
system 132" for short) configured to determine the displacement of
device 10 relative to the skin if or as device 10 is moved across
the surface of the skin (e.g., while operating device 10 in a
gliding mode or a stamping mode), and control one or more
controllable operational parameters of device 10 based on the
determined displacement. For example, displacement-based control
system 132 may control one or more operational aspects of radiation
source(s) 14, such as for example, controlling the radiation mode
of radiation source(s) 14, controlling the on/off status of
radiation source(s) 14, controlling the timing of such on/off
status (e.g., pulse-on time, pulse-off time, pulse duty cycle,
pulse frequency), controlling parameters of the radiation (e.g.,
wavelength, intensity, power, fluence, etc.), controlling
parameters of optics 16, and/or any other controllable operational
parameters of device 10.
[0286] In some embodiments, displacement-based control system 132
may also provide feedback to the user via display 32 and/or one or
more user interfaces 28 based on the monitored displacement of
device 10 and/or the automatic control of one or more controllable
operational parameters by system 132. For example, system 132 may
provide audio and/or visual feedback to the user indicating data
detected, or actions taken, by system 132, e.g., feedback
indicating whether or not the displacement of device 10 exceeds a
predetermined threshold distance, feedback indicating that
treatment radiation source 14 has been turned on or off, feedback
indicating that system 132 has automatically changed the radiation
mode or other parameter of treatment radiation source 14, etc.
[0287] Displacement-based control system 132 may include, utilize,
or otherwise cooperate with or communicate with any one or more of
the control subsystems 52 discussed above with respect to FIG. 2
(e.g., radiation source control system 130, and user interface
control system 134, including user interface sensor control
subsystem 140 and user input/feedback control subsystem 142), as
well as control electronics 30, any one or more sensors 46, user
interfaces 28, and displays 32.
[0288] FIG. 35 illustrates a block diagram of a displacement-based
control system 132, according to certain embodiments.
Displacement-based control system 132 may be provided in any of the
embodiments of device 10 discussed herein. As shown,
displacement-based control system 132 may include a displacement
sensor 100, control electronics 30, and treatment radiation source
14 and/or display 32. In general, displacement sensor 100 collects
data regarding the displacement of device 10 relative to the skin
40 and communicates such data to control electronics 30, which
analyzes the data and controls or provides feedback via one or more
of treatment radiation source 14 and display 32. In some
embodiments, control electronics 30 may also analyze particular
user input received via one or more user interfaces 28 in
conjunction with data received from sensor 100. For example, the
appropriate control or feedback provided by control electronics 30
(e.g., as defined by a relevant algorithm 154) may depend on the
current operational mode and/or other settings selected by the
user. For instance, the minimum threshold displacement for
triggering particular responses by control electronics 30 may
depend on the current operational mode selected by the user.
[0289] Control electronics 30 may include any suitable logic
instructions or algorithms 154 stored in memory 152 and executable
by one or more processors 150 (e.g., as discussed above regarding
FIG. 1) for performing the various functions of displacement-based
control system 132. Displacement sensor 100 may be configured for
detecting, measuring, and/or calculating the displacement of device
10 relative to the skin 40, or for generating and communicating
signals to control electronics 30 for determining the displacement
of device 10. In some embodiments, e.g., as discussed below with
reference to FIGS. 40-43, displacement sensor 100 may be a
single-pixel sensor configured to identify and count intrinsic skin
features in the skin, and determine a displacement of the device 10
across the skin based on the number of identified intrinsic skin
features. As used herein, "intrinsic skin features" include both
(a) surface features of the skin, e.g., textural roughness,
follicles, and wrinkles, and (b) sub-surface features, e.g.,
vascularity and pigmentation features.
[0290] In other embodiments, e.g., as discussed below with
reference to FIG. 45, displacement sensor 100 may be a
multiple-pixel sensor, such as a mouse-type optical sensor
utilizing a two-dimensional array of pixels.
[0291] Depending on the particular embodiment, displacement sensor
100 (or a combination of multiple displacement sensors 100) may be
used for (i) detecting, measuring, and/or calculating displacements
of device 10 in one or more directions, or (ii) detecting,
measuring, and/or calculating the degree of rotation traveled by
device 10 in one or more rotational directions, or (iii) any
combination thereof.
[0292] Displacement-based control system 132, and in particular
control electronics 30, may control one or more controllable
operational parameters of device 10 (e.g., operational aspects of
treatment radiation source 14, fans 34, displays 32, etc.) to
achieve any of a variety of goals. For example, control electronics
30 may control treatment radiation source 14 (a) in order to avoid
overtreatment of the same area of skin, (b) to provide desired
spacing between adjacent or sequential treatment spots 62 or arrays
of spots 62, (c) to generate a relatively uniform pattern, or other
desired pattern, of treatment spots 62, (d) to restrict the
delivery of radiation to particular tissue, such as human skin
(i.e., to avoid delivering radiation to eye or to other non-skin
surfaces), (e) and/or for any other suitable goals, and (f) and
combination of the above.
[0293] In some embodiments, displacement-based control system 132
may be used in both a gliding mode and a stamping mode of device
10.
[0294] FIG. 36 illustrates a flowchart of an example method 400 for
controlling device 10 using displacement-based control system 132,
while device 10 is used either in a gliding mode or a stamping
mode, according to certain embodiments. At step 402, device 10
pulses the beam source(s) of device 10, to generate one or more
treatment spots 62 on treatment area 40. If device 10 is being used
in a gliding mode, the user may glide device 10 across the skin
during the first pulse of the beam source(s). If device 10 is being
used in a stamping mode, the user may hold device 10 stationary on
the skin during the first pulse of the beam source(s).
[0295] At step 404, displacement-based control system 132 performs
a first monitoring process to monitor and analyze the displacement
of device 10 across the surface of the skin using displacement
sensor 100. For example, as discussed below, displacement-based
control system 132 may analyze signal 360 to identify and count
intrinsic skin features 70 in the skin (e.g., in embodiments
utilizing a single-pixel displacement sensor 100 (e.g., sensors
100A, 100B, or 100C discussed below)), or compare images scanned at
different times (in embodiments utilizing a multi-pixel
displacement sensor 100 (e.g., sensor 100D discussed below)), as
device 10 is moved across the skin (e.g., in a gliding mode, during
and/or after the first pulse of the beam source(s); or in a
stamping mode, after the first pulse of the beam source(s)). System
132 may begin the first monitoring process at the initiation or
conclusion of the first pulse of the beam source(s) or upon any
other predefined event or at any predetermined time.
[0296] At step 406, displacement-based control system 132 controls
the pulsing of the beam source(s) based on the displacement of
device 10 determined at step 404. For example, in some embodiments,
displacement-based control system 132 initiates a second pulse of
the beam source(s) upon determining that device 10 has moved a
particular predetermined distance across the skin (e.g., 3 mm).
Thus, in such embodiments, a substantially constant spacing (e.g.,
3 mm) between successive treatment spots 62 in the glide direction
can be achieved regardless of the manual glide speed. Thus, the
pulse frequency may vary dynamically as a function of the manual
glide speed.
[0297] In other embodiments, device 10 (or the user) sets a defined
pulse frequency (e.g., 15 Hz), as well as a predefined minimum
device displacement for providing a predefined minimum spacing
between successive treatment spots 62 in the glide direction (e.g.,
1 mm). Displacement-based control system 132 analyzes the monitored
displacement of device 10 determined at step 404 and the defined
pulse frequency to determine whether the providing the next pulse
according to the defined pulse frequency would violate the minimum
spot spacing (e.g., 1 mm) If not, displacement-based control system
132 allows device 10 to continue pulsing at the defined pulse
frequency. However, if so (i.e., if providing the next pulse
according to the defined pulse frequency would violate the minimum
spot spacing), displacement-based control system 132 may control
radiation source 14 to delay the next pulse at least until system
132 determines that the minimum device displacement has been
achieved (thus ensuring the predefined minimum spacing between
successive treatment spots 62), or system 132 may other control
radiation source 14 to prevent over-treatment (e.g., decreasing the
beam intensity, turning off radiation source 14, providing feedback
to the user, etc.)
Single Pixel Displacement Sensor
[0298] FIG. 37 illustrates an example single-pixel displacement
sensor 100A for use in displacement-based control system 132,
according to certain embodiments. Displacement sensor 100A includes
a light source 310A, a light detector 312A, a light guide 313
having an input and output portions 314 and 316, a half-ball lens
318, a ball lens 320, a housing 322 for housing at least lenses 318
and 320 (and/or other components of sensor 100A), and a and a
microcontroller 330.
[0299] Light source 310A may be a light-emitting diode (LED) or any
other suitable light source. Light source 310A may be selected for
detecting fine details in the surface or volume of human skin.
Thus, a wavelength may be selected that penetrates a relatively
shallow depth into the skin before being reflected. For example,
light source 310A may be a blue LED having a wavelength of about
560 nm, or a red LED having a wavelength of about 660 nm, or an
infrared LED having a wavelength of about 940 nm. Red or infrared
wavelength LEDs are relatively inexpensive and work well in
practice. Alternatively, a semiconductor laser or other light
source could be used.
[0300] Light detector 312A may be a photodiode, phototransistor, or
other light detector. In some embodiments, a phototransistor has
sufficient current gain to provide a directly usable signal,
without requiring additional amplification.
[0301] Light guide 313 is configured to guide light from light
source 310A (via input portion 314) and guide light reflected off
the skin to detector 312A (via output portion 316). Input portion
314 and output portion 316 may comprises optical fibers or any
other suitable light guides. Light guide 313 may be omitted in some
embodiments in which light source 310A and detector 312A are close
enough to the skin surface to image or convey the light directly
onto the skin surface, or alternatively using suitable optics to
image or convey light source 310A and detector 312A directly onto
the skin surface.
[0302] Microcontroller 330 may be configured to drive light source
310A and receive and analyze signals from light detector 312A.
Microcontroller 330 may include an analog-to-digital converter
(ADC) 332 for converting and processing analog signals from light
detector 312A.
[0303] In operation of this embodiment, light (for example, visible
or near-IR energy) from light source 310A travels down input light
guide 314 and through half-ball lens 318 and ball lens 320, which
focuses the light on the skin surface 32. Some of this light is
reflected and/or remitted by the skin and returns through ball lens
320, half-ball lens 318, and output light guide 316, toward light
detector 312A, which converts the light into an electrical signal,
which is then delivered to microcontroller 330. The light may be
modulated to permit discrimination of a constant background ambient
illumination level from the local light source.
[0304] Detector 312A may deliver analog signals to microcontroller
330, which may convert the signals to digital signals (using
integrated ADC 332 or suitable alternatives), and perform
computations regarding on the amplitude of the recorded signal over
time to identify and count features in the skin and determine a
relative displacement device 10 accordingly, as discussed
below.
[0305] The amount of light that is returned to detector 312A is a
strong function of the distance "z" between the sensor optics and
skin surface 32. With no surface present only a very small signal
is generated, which is caused by incidental scattered light from
the optical surfaces. In addition to displacement sensor, this
characteristic can be exploited to provide a contact sensor in
another embodiment. When the skin surface 32 is within the focal
distance of the lens 320, a much larger signal is detected. The
signal amplitude is a function of distance z as well as surface
reflectivity/remittance. Thus, surface texture features on the skin
surface create a corresponding signal variation at detector 312A.
Microcontroller 330 is programmed to analyze this signal and
identify intrinsic skin features 70 that meet particular criteria.
Microcontroller 330 may count identified features and determine an
estimated displacement of sensor 100A relative to the skin 40 in
the x-direction (i.e., lateral displacement), based on knowledge of
estimated or average distances between intrinsic skin features 70
for people in general or for a particular group or demographic of
people, as discussed below.
[0306] Displacement sensor 100A as described above may be referred
to as a "single-pixel" displacement sensor 100A because it employs
only a single reflected/remitted beam of light for generating a
single signal 360, i.e., a single pixel. In other embodiments,
displacement sensor 100 may be a multi-pixel sensor that employs
two pixels (i.e., two reflected beams of light for generating two
signals 360), three pixels, four pixels, or more. Multi-pixel
displacement sensors 100 may be configured such that the multiple
pixels are arranged along a single linear direction (e.g., along
the glide direction, the scan direction, or any other direction),
or in any suitable two-dimensional array (e.g., a circular,
rectangular, hexagonal, or triangular pattern).
[0307] FIG. 38 illustrates another example single-pixel
displacement sensor 100B for use in displacement-based control
system 132, according to certain embodiments. Displacement sensor
100B includes a light source 310B, a light detector 312B, optics
342, and a microcontroller 330.
[0308] Light source 310B and light detector 312B may be provided in
an integrated emitter-detector package 340, e.g., an off-the-shelf
sensor provided by Sharp Microelectronics, e.g., the Sharp GP2S60
Compact Reflective Photointerrupter. Light source 310B may be
similar to light source 310A discussed above, e.g., a
light-emitting diode (LED) or any other suitable light source.
Light detector 312B may be similar to light source 310A discussed
above, e.g., a photodiode, phototransistor, or other light
detector.
[0309] Optics 342 may include one or more optical elements for
directing light from light source 310B onto the target surface and
for directing light reflected/remitted from the target surface
toward light detector 312B. In some embodiments, optics 342
comprises a single lens element 342 including a source light
focusing portion 344 and a reflected light focusing portion 346. As
shown, source light focusing portion 344 may direct and focus light
from light source 310B onto the skin surface 38, and reflected
light focusing portion 346 may direct and focus reflected light
onto detector 312B. Lens element 342 may have any suitable shape
for directing and focusing the source light and reflected light as
desired.
[0310] Microcontroller 330 may be configured to drive light source
310B and receive and analyze signals from light detector 312B.
Microcontroller 330 may include an analog-to-digital converter
(ADC) 332 for converting and processing analog signals from light
detector 312B.
[0311] The operation of sensor 100B--including the operation of
light detector 312B and microcontroller 330--may be similar to that
described above with reference to sensor 100A of FIG. 37. That is,
detector 312B may record a signal having an amplitude or other
property that corresponds to a distance z perpendicular to the
target surface or other properties indicative of intrinsic skin
features. Detector 312B may deliver analog signals to
microcontroller 330, which may convert the signals to digital
signals (using integrated ADC 332), and perform computations
regarding the recorded signal over time to identify and count
features in the skin and determine a relative displacement of
device 10 accordingly.
[0312] Like displacement sensor 100A, displacement sensor 100B may
be referred to as a "single-pixel" displacement sensor 100B because
it employs only a single reflected beam of light for generating a
single signal 360, i.e., a single pixel.
[0313] FIG. 39 illustrates yet another example single-pixel
displacement sensor 100C for use in displacement-based control
system 132, according to certain embodiments. Displacement sensor
100C is generally similar to displacement sensor 100B shown in FIG.
38, but omits the lens element 342 of displacement sensor 100B.
[0314] Displacement sensor 100C includes a light source 310C, a
light detector 312C, optics 342, and a microcontroller 330. Light
source 310C and light detector 312C may be provided in an
integrated emitter-detector package 340, e.g., an off-the-shelf
sensor provided by Sharp Microelectronics, e.g., the Sharp GP2S60
Compact Reflective Photointerrupter. Light source 310C may be
similar to light source 310A/310B discussed above, e.g., a
light-emitting diode (LED) or any other suitable light source.
Microcontroller 330 may be configured to drive light source 310C
with a direct or modulated current. Light detector 312C may be
similar to light source 310A discussed above, e.g., a photodiode,
phototransistor, or other light detector.
[0315] The integrated (or non-integrated) emitter-detector package
340 may be housed in an opaque enclosure 390, having a clear
aperture 392 in the front which is covered by a window 394 (for
example a transparent plastic, or glass). Infrared light from light
source 310C (e.g., LED) shines through the aperture 392 and
impinges on the skin surface 38. Some of this light
(reflected/remitted from the skin 40, as well as scattered from the
interior volume of opaque enclosure 390, returns through aperture
392 and reaches detector 312C (e.g., photodetector), which converts
the received light into an electrical signal. The light may be
modulated to permit discrimination of a constant background ambient
illumination level from the local light source.
[0316] The amount of light that is returned to detector 312C is a
strong function of the distance "z" between the skin surface 38 and
the optical aperture 392. When the skin surface 38 is close to or
in contact with window 394, a larger signal is detected. With no
surface presented to the detector, a smaller optical signal
remains, due to reflections from the surface of opaque mask 390 and
window 394, as well as background light from exterior illumination
sources.
[0317] Thus, the signal amplitude recorded by detector 312C is a
function of z-height as well as skin reflectivity/remittance.
Surface texture features 70 create a corresponding signal variation
at detector 312C. Detector 312C may deliver the recorded analog
signals (with the amplitude being at least indicative of z-height)
to microcontroller 330, which may convert the signals to digital
signals (using integrated ADC 332), and perform computations
regarding the recorded signal over time to identify features 70 in
the skin (based on the signal amplitude), count or otherwise
process such identified features 70, and determine a relative
displacement of device 10 accordingly.
[0318] Integrated emitter-detector pairs used for the proximity
detector may be compact, inexpensive, and readily available. It is
also possible to use a separate emitter and detector. Any suitable
wavelength range of light may be used, but infrared may be selected
due to the sensitivity of the detector 312C (e.g.,
phototransistor), and ability to block out visible light with an
IR-pass filter over the detector. Also, different skin types show
more uniform reflectance levels in IR than in shorter wavelengths.
Test results show that a phototransistor has sufficient current
gain to provide a directly usable signal to the integrated ADC 332
of microcontroller 330, without requiring additional
amplification.
[0319] Like displacement sensors 100A and 100B, displacement sensor
100C may be referred to as a "single-pixel" displacement sensor
100C because it employs only a single reflected beam of light for
generating a single signal, i.e., a single pixel.
[0320] FIG. 40 illustrates a pair of experimental data plots for an
embodiment of optical displacement sensor 100C being scanned above
the skin surface 38 of a human hand. The photodetector signal
(y-axis) is shown versus time (x-axis) in arbitrary units. The area
without dense peaks indicates times in which the sensor aperture
392 is held against a fixed area of the skin. An algorithm takes as
input the photodetector signal to generate the lower "detected
output" plot, which is a signal suitable for controlling device 10.
For example, microcontroller 330 may be programmed to analyze the
photodetector signal and identify intrinsic skin features 70 that
meet particular criteria, e.g., using any of the various techniques
or algorithms disclosed herein, or any other suitable techniques or
algorithms. In some embodiments, microcontroller 330 may count
identified features and determine an estimated displacement of
sensor 100C relative to the skin 40 in the x-direction (i.e.,
lateral displacement), based on knowledge of estimated or average
distances between intrinsic skin features 70 for people in general
or for a particular group or demographic of people, as discussed
below.
[0321] Certain embodiments of single-pixel displacement sensor 100,
e.g., sensors 100A, 100B, and/or 100C discussed above, may not
require imaging optics, as compared to imaging-type sensors.
Further, certain embodiments of single-pixel displacement sensor
100 may not require close proximity between the electronics (e.g.,
microcontroller) and the target surface to be sensed. For example,
the light source and/or detector may be spaced away from the target
surface, with light guides or relay optics used to convey light
between the light source/detector and the target surface. As
another example, the light source and/or detector may be spaced
relative close to the target surface, but may be coupled to a
relatively remote microcontroller by wiring.
[0322] Further, in certain embodiments of single-pixel displacement
sensor 100, e.g., sensors 100A, 100B, and 100C discussed above, the
active components (e.g., light source, detector, etc.) and the
active sensing area are relatively small (e.g., as compared to a
standard optical mouse-type imaging sensor). Thus, in embodiments
in which single-pixel displacement sensor 100 is located at the
application end 42 of device 10, sensor 100 may occupy relatively
little real estate on the application end 42 (e.g., as compared to
a standard optical mouse-type imaging sensor), which may allow the
total size of application end 42 to be reduced in at least one
dimension, which may be advantageous in certain embodiments.
[0323] FIG. 41 represents an example plot 350 of a signal 360
generated by detector 312A, 312B, or 312C as sensor 100A, 100B, or
100C is moved across the skin of a human hand in the x-direction.
The x-axis of plot 350 may be scaled such that the movement of the
signal 360 on the x-axis matches the distance of movement of sensor
100A/100B/100C across the skin.
[0324] The amplitude of the signal 360 corresponds with the texture
of the skin surface, which includes numerous intrinsic skin
features 70. As shown, signal 360 includes a series of peaks 362,
valleys 364, and other characteristics. Intrinsic skin features 70
may be identified from signal 360 based on any suitable parameters
or algorithms.
[0325] For example, one or more of the following criteria may be
used for identifying intrinsic skin features 70 based on signal
360:
[0326] (a) the raw amplitude of a peak 362,
[0327] (b) the amplitude of a peak 362 relative to the amplitude of
one or more other peaks 362 (e.g., one or more adjacent peaks
362),
[0328] (c) the amplitude of a peak 362 relative to the amplitude of
one or more valleys 364 (e.g., one or more adjacent valleys
364),
[0329] (d) the raw amplitude of a valley 364,
[0330] (e) the amplitude of a valley 364 relative to the amplitude
of one or more other valleys 364 (e.g., one or more adjacent
valleys 364),
[0331] (f) the amplitude of a valley 364 relative to the amplitude
of one or more valleys 364 (e.g., one or more adjacent valleys
364),
[0332] (g) the rate of increase in amplitude of signal 362 (i.e.,
positive slope of signal 360) for a particular portion of signal
360,
[0333] (h) the rate of decrease in amplitude of signal 360 (i.e.,
negative slope of signal 360) for a particular portion of signal
362,
[0334] (i) the x-direction distance between adjacent peaks 362
(D.sub.1, D.sub.2, D.sub.3, etc),
[0335] (j) the x-direction distance between adjacent valleys 364,
or
[0336] (k) any other suitable criteria.
[0337] An algorithm 154 may identify intrinsic skin features 70
based on any one or any combination of more than one of the
criteria listed above. Such algorithm 154 may include (predefined
or real-time calculated) threshold values to which one or more of
the criteria listed above are compared. In some embodiments that
identify intrinsic skin features 70 based on peaks 362 in signal
360, the algorithm 154 may be able to distinguish major or global
peaks (e.g., peaks 362) from minor or local peaks (e.g., local peak
368), and use only the major or global peaks 362 for identifying
intrinsic skin features 70. As another example, the algorithm 154
may distinguish major or global valleys (e.g., valleys 364) from
minor or local valleys (e.g., local valley 369), and use only the
major or global valleys 364 for identifying intrinsic skin features
70.
[0338] One example displacement algorithm that may be used with a
single-pixel displacement sensor (e.g., sensor 100A or 100B) to
identify intrinsic skin features 70, and detect displacement of
device 10, is discussed below with reference to FIG. 42. FIG. 42
illustrates three data plots: a raw signal plot 370, filtered
signal plot 372, and an intrinsic skin feature detection plot 374.
The example displacement algorithm takes as input a raw signal from
a photodetector (representing reflectance/remittance vs. time), and
generates as output a digital pulse "1" when a displacement has
been detected, and "0" when no displacement has been detected. In
FIG. 42, each plot 370, 372, and 374 shows the specified signals
plotted against time on the horizontal axis.
[0339] Raw signal plot 370 shows the raw input signal "pd1" 376,
which includes amplitude variations corresponding to displacement
of the sensor across the skin (the amplitude variations correspond
to intrinsic skin features 70 on the skin), and flatter areas
corresponding to the sensor dwelling in the same place on the
skin.
[0340] As shown in filtered signal plot 372, the algorithm extracts
a high-pass filtered version "diff1" 378 of the raw signal pd1 and
also a positive-tracking and negative-tracking envelope indicated
as "max1" 380 and "min1" 382, respectively. The positive envelope
"max1" 380 is created at each point in time by adding a fraction of
the current high-pass-filtered positive signal "dif1p" to the
previous time-step value of the positive envelope signal "max1",
where "dif1p" is formed from the high-pass filtered signal
"dif1":
dif1p=dif1 (dif1>0)
dif1p=0 (dif1<=0)
[0341] Similarly, the negative envelope "min1" 382 is created the
same way from "dif1n", which is the high-pass filtered negative
signal:
dif1n=dif1 (dif1<0)
dif1n=0 (dif1>=0)
[0342] Finally, as shown in the intrinsic skin feature detection
plot 374, the feature-detect signal "d1" 384 is set to 1 at any
time step in which "dif1" has a zero crossing (i.e., where previous
time step and current time step have a different sign) AND "max1"
exceeds a threshold value, AND "min1" exceeds a threshold value.
Otherwise, "d1" is set to 0. The threshold limits may be designed
to prevent non-desirable outputs (e.g., feature-detection false
positives and/or false negatives) due to random sensor or circuit
noise levels. The zero-crossing requirement may also be designed to
prevent non-desirable outputs (e.g., feature-detection false
positives and/or false negatives) when the photosignal dif1 is
entirely positive or negative, as when the photosensor is initially
brought up against a surface (signal shows large increase with
time), or removed from it (signal decreases).
[0343] From feature detection plot 374, the displacement of the
sensor relative to the skin can be determined by counting the
number of detected features 70. The algorithm may then make control
decisions by (a) comparing the number of detected features 70 to
one or more predetermined threshold numbers (e.g., allow continued
treatment if at least three features 70 have been detected), or (b)
by multiplying the number of detected features 70 by a known
nominal or average distance between features 70 (e.g., as
determined based on experimental testing) to determine displacement
distance (e.g., in millimeters), and then comparing the determined
displacement distance to one or more predetermined threshold
distances (e.g., allow continued treatment if the determined
displacement exceeds 2 mm). It can be appreciated by one of
ordinary skill in the art that, if desired, this embodiment could
also be used to create a velocity sensor if rate information was
also obtained and used or a dwell sensor.
[0344] In some embodiments, the example algorithm may be utilized
in a system including a single sensor (e.g., single-pixel
displacement sensor 100A or 100B) having a single detector (e.g.,
detector 312A or 312B). In other embodiments, the example algorithm
may be utilized in a system with more than one sensors (e.g., more
than one sensor 100A and/or 100B) or with a sensor 100 that
includes more than one detector 312 (e.g., a sensor 100A or 100B
including more than one detector 312A or 312B). Such embodiments
may thus generate multiple feature detection signals 384, each
corresponding to a different sensor 100 or detector 312 with the
same type of features detected or different types of features
detected.
[0345] In embodiments including multiple sensors 100 or detectors
312, the algorithm may make control decisions based on the multiple
feature detection signals 384 in any suitable manner. For example,
the algorithm may generate a control signal only if each of the
multiple feature detection signals 384 detects a predetermined
number of features 70 (which may provide relatively greater
resistance to noise or possible fault conditions). Or, the
algorithm may generate a control signal if any of the multiple
feature detection signals 384 detects a predetermined number of
features 70 (which may provide relatively greater detection
sensitive for surfaces with less texture and smaller amplitude
reflectance features). Or, the algorithm may generate control
signals based on the total number of features 70 detected by the
multiple feature detection signals 384. The algorithm can also be
designed to the identify an outlier feature detection signal 384
(as compared to the other feature detection signal 384), and ignore
such signal 384, at least while it remains an outlier.
[0346] A sample of humans was tested with a particular embodiment
of sensor 100A, and identifying intrinsic skin features 70
according to the example algorithms discussed above. The testing
involved moving sensor 100A in a straight line across the surface
of the test subjects' skin, such as face or arm skin. The resulting
test data using the particular embodiment of sensor 100A indicated
that adjacent intrinsic skin features 70 (texture or roughness, in
this case) are located about 0.3-0.4 mm apart on average. In other
words, with reference to FIG. 40, the test data indicated an
average spacing D.sub.1, D.sub.2, D.sub.3, etc. of about 0.3-0.4
mm.
[0347] The displacement of device 10 can be determined or
approximated using this experimental data, e.g., the average
spacing between intrinsic skin features 70. For example, the
displacement of device 10 can be determined or approximated by
multiplying the number of intrinsic skin features 70 identified by
system 132 by the experimentally determined average spacing between
intrinsic skin features 70.
[0348] Thus, displacement-based control system 132 (in particular,
control electronics 30) may control device 10 based on the
determined or approximated displacement of device 10 across the
skin. For example, displacement-based control system 132 may
control one or more controllable operational parameters of device
10 (e.g., operational aspects of treatment radiation source 14)
based on the number of intrinsic skin features 70 identified by
system 132 for a displacement of device 10 across the skin. For
example, system 132 may control device 10 to pulse the beam
source(s) of device 10 (thus generating one or more treatment spots
62) each time device 10 is displaced X mm, as determined by
identifying N intrinsic skin features 70. For example, if
experimental data indicates that intrinsic skin features 70 are
spaced by an average of 0.4 mm, system 132 may control device 10 to
pulse the beam source(s) each time device 10 is displaced
approximately 1.2 mm, as determined by identifying three intrinsic
skin features; the next pulse of the beam source(s) is not
initiated delivered until/unless device 10 is displaced another
approximately 1.2 mm (i.e., until three intrinsic skin features 70
are identified by system 132). Additional details and examples of
the control of device 10 by system 132 are provided below.
[0349] Thus, in some embodiments, control systems 18, including
displacement-based control system 132, controls operational aspects
of device 10 (e.g., operational aspects of treatment radiation
source 14) based on the displacement of device 10 across the skin,
independent of the rate, speed, or velocity of device 10 moving
across the skin. In some embodiments device 10, including
displacement-based control system 132, is not configured for
detecting or measuring any data indicative of the rate, speed, or
velocity of device 10 moving across the skin, or for determining or
attempting to determine the rate, speed, or velocity of device 10
moving across the skin. Rather, device 10 is configured for
detecting or measuring data indicative of the lateral displacement
of device 10 relative to the skin, and for determining the lateral
displacement of device 10 using such data, e.g., as discussed
above. In other words, device 10 can be moved at any rate,
including very slowly, and pulses are delivered only if sufficient
distance been translated relative to prior pulse location.
[0350] In other embodiments, device 10 may include a speed
detection system, e.g., including a motion/speed sensor 102, for
detecting or measuring data indicative of the rate, speed, or
velocity of device 10 moving across the skin, and for determining
or attempting to determine the rate, speed, or velocity of device
10 based on such data. Such speed detection sensor or system may be
provided in addition to, or in place of, displacement-based control
system 132 and displacement sensor 100A.
[0351] In other embodiments, device 10 may include a dwell sensor
116 for measuring data indicative of whether device 10 is
stationary or stationary within a certain tolerance with respect to
the skin. Dwell sensor 116 may employ aspects of displacement
sensor 100 described above but may be configured to provide
information specifically about whether device 10 is stationary. For
example, all or portions of the example algorithm described above
for single-pixel displacement sensor 100A/100B may be used to
determine when device 10 is substantially stationary (e.g., by
recognizing the flat spots in the raw data signal 376 shown in FIG.
42) and device 10 may be controlled based on that information
(e.g., radiation source 14 may be disabled if device 10 is
determined to be stationary or dwelling).
[0352] FIG. 43 illustrates a more specific example of the general
method 400 of FIG. 36. In particular, FIG. 43 illustrates a method
420 for controlling device 10 using displacement-based control
system 132 that employs a single-pixel displacement sensor 100A,
100B, or 100C, while device 10 is used either in a gliding mode or
a stamping mode, according to certain embodiments.
[0353] At step 422, device 10 pulses the beam source(s) of device
10, to generate one or more treatment spots 62 on treatment area
40, as discussed above regarding step 402. If device 10 is being
used in a gliding mode, the user may glide device 10 across the
skin during the first pulse of the beam source(s). If device 10 is
being used in a stamping mode, the user may hold device 10
stationary on the skin during the first pulse of the beam
source(s).
[0354] At step 424, displacement-based control system 132 performs
a first monitoring process to monitor and analyze the displacement
of device 10 across the surface of the skin using single-pixel
displacement sensor 100A/100B/100C. For example, as discussed
below, displacement-based control system 132 may analyze signal 360
to identify and maintain a count of intrinsic skin features 70 in
the skin as device 10 is moved across the skin (e.g., in a gliding
mode, during and/or after the first pulse of the beam source(s); or
in a stamping mode, after the first pulse of the beam source(s)).
System 132 may begin the first monitoring process at the initiation
or conclusion of the first pulse of the beam source(s) or upon any
other predefined event or at any predetermined time.
[0355] At step 426, displacement-based control system 132 controls
the pulsing of the beam source(s) based on the number of intrinsic
skin features 70 identified at step 424. For example, in some
embodiments, displacement-based control system 132 initiates a
second pulse of the beam source(s) upon identify a predetermined
number of features 70 in the skin (e.g., 5 features). Thus, in such
embodiments, a relatively constant spacing (e.g., a spacing
corresponding to 5 skin features) between successive treatment
spots 62 in the glide direction can be achieved regardless of the
manual glide speed. Thus, the pulse frequency may vary dynamically
as a function of the manual glide speed.
[0356] In other embodiments, device 10 (or the user) sets a defined
pulse frequency (e.g., 15 Hz), as well as a predefined minimum
number of intrinsic skin features 70 (e.g., 3 features)
corresponding to a desired minimum spacing between successive
treatment spots 62 in the glide direction (e.g., about 1 mm).
Displacement-based control system 132 analyzes the count of
identified features 70 maintained at step 424 and the defined pulse
frequency to determine whether the providing the next pulse
according to the defined pulse frequency would violate the minimum
feature count (e.g., 3 features) between successive pulses. If not,
displacement-based control system 132 allows device 10 to continue
pulsing at the defined pulse frequency. However, if so (i.e., if
providing the next pulse according to the defined pulse frequency
would violate the minimum feature count), displacement-based
control system 132 may control radiation source 14 to delay the
next pulse at least until the minimum feature count is achieved by
system 132 (thus providing a minimum spacing (e.g., about 1 mm)
between successive treatment spots 62), or system 132 may other
control radiation source 14 to prevent over-treatment (e.g.,
decreasing the beam intensity, turning off radiation source 14,
providing feedback to the user, etc.)
[0357] Thus, in certain embodiment, control of device 10 (e.g.,
controlling the pulse timing or other aspects of treatment
radiation source 14) to provide a desired spot spacing and/or to
avoid over-treatment of a particular area is not based on any
signals related to the rate, speed, or velocity of device 10 moving
across the skin. As discussed above, in some embodiments device 10
is not configured for detecting or measuring any data indicative of
the rate, speed, or velocity of device 10 moving across the skin,
or for determining or attempting to determine the rate, speed, or
velocity of device 10 moving across the skin.
Multi-Pixel Displacement Sensor
[0358] As mentioned above, in some embodiments displacement sensor
100 is a multi-pixel displacement sensor 100 that employs two
pixels (i.e., two reflected beams of light for generating two
signals 360), three pixels, four pixels, or more. For example, some
embodiments employ a multi-pixel imaging correlation sensor 100D,
of the type used in optical mice for computer input, for detecting
displacement along the skin.
[0359] FIG. 44 illustrates an example multi-pixel imaging
correlation sensor 100D, of the type used in optical mice for
computer input, for detecting displacement along the skin,
according to certain embodiments. Displacement sensor 100D may
include a light source 310D, a light detector 312D, and a processor
334.
[0360] Light source 310D may be a light-emitting diode (LED) or any
other suitable light source, e.g., as discussed above regarding
light source 310A. Light source 310D may be arranged to deliver
light at an oblique angle with respect to the skin surface 32, as
shown in FIG. 44.
[0361] Light detector 312D may include a molded lens optic 336 and
an imaging chip 338. In some embodiments, sensor 100D is configured
such that the skin is within the focal plane of molded lens optic
336, which focal plane may be located several millimeters away from
the surface of molded lens optic 336, as indicated by distance z in
FIG. 44. Optionally, a system of relay lenses may be added between
detector 312D and skin surface 32 to extend the total distance from
the external focal plane to detector 312D.
[0362] Detector 312D may be configured to generate a
two-dimensional multi-pixel "image" of the area of skin surface 32
illuminated by light source 310D. The image may consists of a
two-dimensional array of pixels, each pixel having a signal 360
similar to signal 360 of single-pixel sensor 100A or 100B. Imaging
chip 338 may be configured to generate a digital output stream to
processor 334 corresponding to the multi-pixel signal array.
[0363] Processor 334 may be configured to drive light source 310D
and receive and analyze the multi-pixel array of signals from light
detector 312D. In particular, processor 334 may compare different
multi-pixel images received from detector 312D (e.g., successively
received images) to determine linear displacements in one or more
directions, rotational displacements, and/or lateral displacements
of sensor 100D across the skin surface 32.
[0364] It should be understood that although the example
embodiments discussed above may be suitable for detecting
roughness-type skin features, other embodiments of sensor 100 may
detect any other types of intrinsic skin features, such as pigment
detection in the epidermis or epidermis/dermal junction or
vascularity patterns such as the microvasculature in the skin, for
example, using similar or analogous techniques to those discussed
above.
[0365] FIG. 45 illustrates an example method 440 for controlling
device 10 using displacement-based control system 132 that employs
a multi-pixel displacement sensor 100D, while device 10 is used
either in a gliding mode or a stamping mode, according to certain
embodiments.
[0366] At step 442, device 10 pulses the beam source(s) of device
10, to generate one or more treatment spots 62 on treatment area
40, as discussed above regarding step 402. If device 10 is being
used in a gliding mode, the user may glide device 10 across the
skin during the first pulse of the beam source(s). If device 10 is
being used in a stamping mode, the user may hold device 10
stationary on the skin during the first pulse of the beam
source(s).
[0367] At step 444, displacement-based control system 132 performs
a first monitoring process to monitor and analyze the lateral
displacement of device 10 across the surface of the skin using
multi-pixel sensor 100D. Displacement-based control system 132
analyzes signals 360 as device 10 is moved across the skin (e.g.,
in a gliding mode, during and/or after the first pulse of the beam
source(s); or in a stamping mode, after the first pulse of the beam
source(s)). System 132 may begin the first monitoring process at
the initiation or conclusion of the first pulse of the beam
source(s) or upon any other predefined event or at any
predetermined time.
[0368] At step 446, displacement-based control system 132 controls
the pulsing of the beam source(s) based on the displacement of
device 10 determined at step 444. For example, in some embodiments,
displacement-based control system 132 initiates a second pulse of
the beam source(s) upon determining that device 10 has moved a
particular predetermined distance across the skin (e.g., 3 mm),
based on signals from multi-pixel sensor 100D. Thus, in such
embodiments, a substantially constant spacing (e.g., 3 mm) between
successive treatment spots 62 in the glide direction can be
achieved regardless of the manual glide speed. Thus, the pulse
frequency may vary dynamically as a function of the manual glide
speed.
[0369] In other embodiments, device 10 (or the user) sets a defined
pulse frequency (e.g., 15 Hz), as well as a predefined minimum
device displacement for providing a predefined minimum spacing
between successive treatment spots 62 in the glide direction (e.g.,
1 mm). Displacement-based control system 132 analyzes the monitored
displacement of device 10 determined at step 444 (based on signals
from multi-pixel sensor 100D) and the defined pulse frequency to
determine whether the providing the next pulse according to the
defined pulse frequency would violate the minimum spot spacing
(e.g., 1 mm). If not, displacement-based control system 132 allows
device 10 to continue pulsing at the defined pulse frequency.
However, if so (i.e., if providing the next pulse according to the
defined pulse frequency would violate the minimum spot spacing),
displacement-based control system 132 may control radiation source
14 to delay the next pulse at least until system 132 determines
that the minimum device displacement has been achieved (thus
ensuring the predefined minimum spacing between successive
treatment spots 62), or system 132 may other control radiation
source 14 to prevent over-treatment (e.g., decreasing the beam
intensity, turning off radiation source 14, providing feedback to
the user, etc.)
[0370] Thus, in certain embodiment, control of device 10 (e.g.,
controlling the pulse timing or other aspects of treatment
radiation source 14) to provide a desired spot spacing and/or to
avoid over-treatment of a particular area is not based on any
signals related to the rate, speed, or velocity of device 10 moving
across the skin. As discussed above, in some embodiments device 10
is not configured for detecting or measuring any data indicative of
the rate, speed, or velocity of device 10 moving across the skin,
or for determining or attempting to determine the rate, speed, or
velocity of device 10 moving across the skin.
Roller-Type Displacement Sensor 100 or Motion/Speed Sensor 102
[0371] In some embodiments, device 10 may include one or more
roller-based sensors 118 that function as a displacement sensor
100, or dwell sensor 116 or as a motion/speed sensor 102, or all.
Roller-based sensor 118 may be arranged at or near the treatment
tip 42 of device 10, and may include a roller 450 having a leading
surface that is generally flush with, or projects slightly forward
from the leading surface of the surrounding or adjacent portion of
housing 24. In some embodiments, the leading surface of roller 450
may define a skin-contacting surface 74, which may or may not
affect the distance (if any) of the treatment window 44 from the
skin surface, e.g., depending on the closeness of the roller 405 to
the window 44 and/or the force at which device 10 is pressed
against the skin by the user.
[0372] FIGS. 46A-46G illustrate some example embodiments of a
roller-based sensor 118A-118G that may be used in certain
embodiments of device 10. Each embodiment includes a roller 450
coupled (e.g., mechanically, optically, magnetically, electrically,
etc.) to a detection system 452 configured to generate signals
indicative of (a) the displacement of device 10 (e.g., based on a
detected amount of angular rotation of roller 45), or (b) the
manual glide speed of device 10 (e.g., based on a detected speed of
rotation of roller 45), or (c) a dwell sensor (e.g., based on
rotation or not rotation), or (d) all of the above.
[0373] As device 10 is manually moved across the skin, roller 450
turns or "rolls" by a degree and at a speed corresponding to the
lateral displacement and manual glide speed, respectively, of the
device relative to the skin surface. Detection system 452, via its
coupling or interaction with roller 450, generates signals
indicative of the lateral displacement and/or manual glide speed,
and communicates such signals to processor 150, which may convert
and/or process such signals to determine the displacement and/or
glide speed and/or stationary status of device 10. The determined
displacement and/or glide speed and/or stationary status of device
10 may then be used for controlling one or more controllable
operational parameters of device 10 (e.g., control operational
parameters of radiation source 14), e.g., as discussed herein.
[0374] In some embodiments, roller-based sensor 118 is configured
to operate as a displacement sensor 200 for use in
displacement-based control system 132, and may be used for any of
the displacement-based control techniques discussed herein. In some
embodiments, roller-based sensor 118 measures, detects, or
generates signals indicative of, the displacement of device 10, but
does not measure, detect, or generate signals indicative of, the
manual glide speed of device 10.
[0375] In an example embodiment, roller 450 has a diameter of about
4 mm, such that a 29 degree rotation of roller 450 corresponds to 1
mm displacements of device 10 (assuming no slipping between roller
450 and skin). In some embodiments, detection system 452 may be
sensitive to device displacements to a granularity of about 1
mm.
[0376] FIG. 46A illustrates an example roller-based sensor 118A
that includes a belt-driven optical-interrupt detection system 452A
to generate signals indicative of the displacement and/or glide
speed of device 10.
[0377] FIGS. 46B and 46C illustrate an example roller-based sensor
118B that includes a detection system 452B that generates signals
indicative of the displacement and/or glide speed of device 10
based on the flexure of a physical arm, which causes strain across
a Wheatstone bridge, thus causing changes in resistance
corresponding to device movement.
[0378] FIG. 46D illustrates an example roller-based sensor 118D
that includes a detection system 452D that generates signals
indicative of the displacement and/or glide speed of device 10
based on an interaction between a Hall-effect sensor and one or
more magnets around the perimeter of roller 450.
[0379] FIG. 46E illustrates an example roller-based sensor 118E
that includes a detection 452E to generate signals indicative of
the displacement and/or glide speed of device 10 based on a
measured capacitance between an "antenna" and a gear or other
rotating element.
[0380] FIG. 46F illustrates an example roller-based sensor 118F
that includes a detection system 452F to generate signals
indicative of the displacement and/or glide speed of device 10
based on measurements of reflected optical radiation.
[0381] Finally, FIG. 46G illustrates an example roller-based sensor
118G that includes a gear-driven optical-interrupt detection system
452G to generate signals indicative of the displacement and/or
glide speed of device 10.
Capacitive Sensors
[0382] One or more sensors 46 of device 10 may be, or may include,
capacitive sensors. As discussed above, skin-contact sensor 104 may
be a capacitive sensor, in which the signal amplitude is analyzed
to determine whether sensor 104 is in contact or sufficient
proximity with the skin. In addition, any of displacement sensor
100, motion/speed sensor 102, and/or dwell sensor 116 may be
capacitive sensors, or may include capacitive sensors in addition
to other types of sensors (e.g., a sensor 100, 102, or 116 may
include an optical reflectance/remittance sensor in addition to a
capacitive sensor for providing the desired functionality, e.g., to
provide redundancy).
[0383] A capacitive sensor in contact with the skin (e.g., a
capacitive sensor located at the application end 42 of device 10
may generate a signal (e.g., a high-frequency signal) indicating a
measure of capacitance associated with the contact between the
sensor and the skin. For example, a capacitive sensor's signal may
be inversely proportional to the relative displacement between the
sensor and the target surface. Because the surface of a human's
skin is not perfectly smooth and/or because a human cannot achieve
perfectly steady motion during manual movement of device 10, static
friction (stiction) between device 10 and the skin and/or other
physical principles may result in "stick-and-slip" movement of
device 10 across the skin, which causes micro-displacement between
the sensor and the skin surface. This micro-displacement due to
stick-and-slip movement of device 10 may result in a translational
signal added to the nominal steady-state capacitance signal of the
sensor, to provide a total capacitance signal. The amplitude and/or
other aspects of the total capacitance signal may be analyzed to
determine whether the device is moving across the skin, or dwelling
at the same location. Thus, a capacitive sensor may be used as a
dwell sensor 116. Such analysis may include any suitable
algorithms, e.g., comparing the signal to one or more threshold
values.
[0384] As another example, the total capacitance signal may be
analyzed to determine or estimate the speed of device 10 moving
across the skin. Thus, a capacitive sensor may be used as a
motion/speed sensor 102. As another example, the total capacitance
signal may be analyzed to determine or estimate the displacement of
device 10 moving across the skin. Thus, a capacitive sensor may be
used as a displacement sensor 100.
Treatment Sessions
[0385] In some embodiments, control systems 18 define and control
individual treatment sessions based on one or more "treatment
delimiters" such as (a) a total number of treatment spots 62
generated in the treatment area 40, (b) a total amount of energy
delivered to the treatment area 40, (c) a total treatment time, or
any other suitable delimiter(s).
[0386] In some embodiments, treatment delimiters are specified for
different "types" of treatments. Different types of treatments may
include (a) treatments for different areas of the body (e.g.,
periorbital area, areas near the mouth, the back of the hand, the
stomach, the knees, etc.), (b) different treatment energy or
intensity levels (e.g., high energy treatment, medium energy
treatment, low energy treatment), (c) different treatments for
different stages of a multi-session treatment plan (e.g., a first
session treatment, a mid-stage session treatment, or a
final-session treatment), or any other different types of
treatments.
[0387] Further, treatment delimiters may be specified for different
combinations of treatment types. For example, different values for
"total treatment spots 62 generated" may be specified for different
combinations of treatment area and treatment energy level: (a)
4,000 treatment spots 62 for high energy periorbital treatment, (b)
7,000 treatment spots 62 for low energy periorbital treatment, (c)
6,000 treatment spots 62 for high energy hand treatment, and (d)
10,500 treatment spots 62 for low energy hand treatment.
[0388] Treatment delimiters for different treatment types (or
combinations of different treatment types) may be predetermined and
programmed into device 10, set or modified by a user via a user
interface 18, determined by device 10 based on user input, sensors
(such as skin temperature sensors), settings stored in device 10,
and/or algorithms 154 stored in device 10, or determined in any
other suitable manner. In some embodiments, treatment delimiters
for different treatment types are determined based on experimental
testing and preprogrammed into device 10. For example, experimental
testing may determine that an appropriate treatment session for a
periorbital region involves 1,000 treatment spots 62, an
appropriate treatment session for a mouth region involves 1,300
treatment spots 62, and an appropriate treatment session for the
back of the hand involves 2,700 treatment spots 62. These treatment
delimiters may be stored in device 10 and implemented by control
systems 18 as appropriate when a user selects from a "periorbital
treatment," "mouth treatment," or "hand treatment" via user
interface 18.
[0389] Where treatment sessions are defined by treatment delimiters
that are not time-based, such as treatment sessions defined by (a)
a total number of treatment spots 62 or (b) a total amount of
energy delivered to the target, the manual glide speed of device 10
across the skin--with the possible exception of extremely fast
glide speeds--may be largely or substantially irrelevant to the
effectiveness of the treatment delivered during the session, at
least in certain embodiments or configurations of device 10. For
example, the manual glide speed may influence the number of times
device 10 must be glided across the treatment area 40 to complete
the treatment session (e.g., the faster the manual glide speed, the
more glides are required to complete the session), but does not
affect the specified treatment delimiter for the session, e.g., the
total number of treatment spots 62 or the total amount of energy
delivered to the treatment area 40.
[0390] Further, in some embodiments, the effectiveness of the
treatment, as related to the spacing between treatment spots 62, is
generally not affected by the manual glide speed of device 10. In
embodiments that include displacement-based control system 132,
which controls beam delivery, and thus treatment spot 62
generation, based on the determined displacement of device 10
across the skin, system 132 ensures at least a minimum spacing
between successively delivered treatment spots 62, which reduces or
substantially eliminates the chances of over-irradiation of any
area. In particular, displacement-based control system 132 may
ensure at least a minimum spacing between successively delivered
treatment spots 62 during slow glide speeds, and without detecting
or determining the manual glide speed. Thus, displacement-based
control system 132 may reduce or substantially eliminate the
chances of over-irradiation of any particular area, even for very
slow glide speeds.
[0391] Further, where the treatment session involves multiple
glides of device 10 across the treatment areas 40, the treatment
spots 62 generated during different glides typically will not align
with other, which generally results in an treatment spot 62 pattern
with sufficient or desirable randomness and/or density uniformity
to provide the desired treatment effects, without significantly
over-irradiating any areas. Thus, although rapid glide speeds may
require the user to perform more glides to reach the relevant
treatment delimiter (e.g., total treatment spots 62 generated or
total energy delivered), rapid glide speeds may provide a
sufficient or desirable treatment spot 62 patterns, without
over-irradiating any areas.
[0392] It should be noted that the manual glide speed may influence
the shape of individual treatment spots 62, e.g., the extent of
elongation, "blurring," or "smearing" of treatment spots 62, such
as described above. Thus, operational aspects of device 10 may be
configured such that within a reasonable range of glide speeds
(i.e., less than very fast glide speeds), the elongation or
smearing of treatment spots 62 does not substantially affect the
physiological effectiveness of the treatment spots 62. In some
embodiments or configurations of device 10, at very high glide
speeds, the elongation or smearing of treatment spots 62 may
significantly reduce the effectiveness of the treatment. For
example, the energy density within a very elongated treatment spot
62 may be too low to provide the intended effects. Thus, the user
may be provided general guidance (e.g., via display 32 or in a user
manual) regarding the appropriate manual glide speed for the
desired treatment effects. For example, the user may be instructed
to glide device 10 across the treatment area 40 at manual glide
speed of roughly three seconds per glide. The device may be
configured to provide effective therapy at substantially all
practical, or common, glide speeds used by consumers, on that
therapy is substantially independent of glide speed.
[0393] FIG. 47 illustrates an example method 460 for executing a
treatment session for providing treatment (e.g., fractional light
treatment) to a user with device 10. At step 462, one or more
delimiters for a treatment session to be performed are determined
in any suitable manner, e.g., as discussed above. For the purposes
of this discussion it is assumed that a single treatment delimiter
is determined. For example, control systems 18 may determine a
predefined total number of treatment spots 62 for the treatment
session based on a treatment area (e.g., periorbital area) selected
by the user via a user interface 18: for example, 1200 treatment
spots 62. (The number of treatment spots 62 may be assumed here to
be equal to the number of beams 60 output by device 10).
[0394] At step 464, after the user has positioned device 10 against
the treatment area 40, device 10 may begin the treatment session.
In particular, control systems 18 may deliver manually scanned
arrays (e.g., rows) of beams to the treatment area 40, thus
generating an array of treatment spots 62, as indicated at step
466. If device is operating in a gliding mode, device 10 may glided
across the skin continuously during the beam-delivery process. If
device is operating in a stamping mode, device 10 may held in place
during each pulse, and then moved, or glided, across the surface of
skin to the next treatment location for the next pulse. The user
may be instructed (e.g., by audible or visible notifications) when
each pulse is delivered, and/or whether or when device 10 has been
moved a sufficient distance for initiating the next pulse (as
determined by displacement monitoring and control system 132). In
either the gliding mode or the stamping mode, the user may glide or
move the device across the treatment area 40 any number of times
and any number of directions or patterns (e.g., to "paint" a
two-dimensional target area) during the treatment session.
[0395] During the treatment session, as indicated as step 468,
displacement monitoring and control system 132 may monitor the
lateral displacement of device as it moves across the skin and
control the delivery of beams/generation of treatment spots 62
accordingly, as discussed above. For example, system 132 may ensure
that consecutive rows of treatment spots 62 are spaced apart in the
glide direction by at least a minimum distance.
[0396] Also during the treatment session, control systems 18 may
monitor the treatment delimiter determined at step 462, as
indicated at step 470. For example, control systems 18 may maintain
a running count of the number of treatment spots 62 generated
during the treatment session. Steps 468 and 470 may be performed
concurrently throughout the duration of the treatment session.
[0397] At step 472, control systems 18 determines whether the
treatment delimiter has reached the predetermined limit. For
example, control systems 18 may determine whether the number of
treatment spots 62 that have been generated during the session has
reached the predefined number of treatment spots 62 determined at
step 462 (e.g., 1200 treatment spots 62). If so, the treatment
session is completed at step 474. For example, control systems 18
may turn off treatment radiation source 14. If not, steps 466-472
are continued until the treatment delimiter is reached.
[0398] In some embodiments, a treatment session for providing
treatment (e.g., fractional light treatment) to a user may be
completed according to method 460 without regard to the manual
glide speed of device 10 across the skin, e.g., as discussed
above.
Eye Safety Sensor
[0399] In some embodiments, device 10 includes an optical eye
safety sensor 114 configured to detect the presence of a cornea (or
other eye tissue or feature) near a treatment output aperture of
device 10, in order to help prevent unintended eye exposure to
light from the treatment radiation source 14. For example, optical
eye safety sensor 114 may be configured to distinguish between the
presence of skin and the cornea, and enable device 10 to treat only
the intended treatment area 40. Eye safety sensor 114 may be
especially important for infrared treatment light of wavelength
greater than 1400-nm, for which the eye injury risk is primarily in
the cornea or for UV, visible, and/or near-IR where retinal hazards
exist. In some embodiments, optical eye safety sensor 114 is
relatively low cost, compact, easily packaged within a handheld
enclosure (e.g., small and lightweight), and assembled from
commonly available parts. Another example embodiment of an eye
safety sensor is an imaging sensor with pattern recognition for
shape, color, or other feature of the eye.
[0400] FIG. 48 illustrates an example optical eye safety sensor
114, according to certain embodiments. Optical eye safety sensor
114 may include a light source 510, a light detector 512, detector
optics 520, relay optics 522 (in some embodiments), and a
microcontroller 530.
[0401] Light source 510 may be a light-emitting diode (LED) or any
other suitable light source. Light source 510 may be selected for
showing fine details in the surface of human skin. Thus, a
wavelength may be selected that penetrates a relatively shallow
depth into the skin before being reflected. For example, light
source 510A may be a blue LED having a wavelength of about 560 nm,
or a red LED having a wavelength of about 660 nm, or an infrared
LED having a wavelength of about 940 nm. Red or infrared wavelength
LEDs are relatively inexpensive and work well in practice.
Alternatively, a semiconductor laser could be used.
[0402] Light detector 512 may be a photodiode, phototransistor, or
other light detector. In some embodiments, a phototransistor has
sufficient current gain to provide a directly usable signal,
without requiring additional amplification. Light detector optics
520, e.g., a half-ball lens, may be coupled to or carried with
light detector 512. Light detector optics 520 may be configured to
allow light detector 512 to "view" a target surface location.
[0403] Further, in some embodiments, sensor 114 may include relay
optics 522 for relaying light from light source 510 and/or relay
optics 522 for relaying reflected light to detector 512. Relay
optics 522 may be used to relay light for any desired distance,
such that one, some, or all of light source 510, detector optics
520, and/or detector 512 may be located at any desired distance
from an aperture 526 in housing 24 that may be configured to be
positioned on or near the skin surface 32 during use. Also,
microcontroller 530 and/or other electronics associated with sensor
114 may be located at any distance from aperture 526 and/or from
the other components of sensor 114 (e.g., light source 510,
detector 512, detector optics 520, and optional relay optics 522).
In some embodiments, locating components of sensor 114 away from
aperture 526 may reduce or minimize the space occupied by sensor
114 at treatment tip 42 of device 10, which may allow for a reduced
or minimized size of treatment tip 42, which may be desirable or
advantageous.
[0404] In other embodiments, components of sensor 114 may be
located near aperture 526 (e.g., in the treatment tip 42 of device
10), such that relay optics 520 are not included.
[0405] Light source 510 may be oriented to illuminate a surface
(e.g., skin surface 32) at a very low angle of incidence (e.g.,
.theta. shown in FIG. 49 may be between about 5 and 40 degrees),
while detector 512 may be aligned at a normal or near-normal angle
of incidence relative to the illuminated surface.
[0406] Microcontroller 530 may be configured to drive light source
510 (e.g., an LED) with a direct or modulated current, record a
signal 524 from detector 512 using an integrated ADC 532, and
analyzes the amplitude of the recorded detector signal 524 to
determine if the surface below detector 512 is skin 32 or cornea
500.
[0407] The signal 524 from detector 512 may be referred to as a
"reflectance feedback signal." The amplitude of the reflectance
feedback signal 524 corresponds to the intensity of reflected light
from light source 510 received by detector 512: the more light from
light source 510 that is reflected into detector 512, the higher
the amplitude of reflectance feedback signal 524. As discussed
below, due to the configuration of light source 510 and detector
512, skin (which is relatively diffuse) reflects more of light from
light source 510 into detector 512 than the cornea (which is
relatively specular). Thus, microcontroller 530 may analyze the
amplitude of reflectance feedback signal 524 (e.g., using threshold
or window comparisons) to determine whether the surface below
detector 512 is skin 32 or cornea 500.
[0408] Signals from microcontroller 530 indicating whether a
treatment window 44 of device is located above skin or the cornea
may be used by control systems 18 for controlling one or more
controllable operational parameters of device 10.
[0409] For example, treatment (e.g., delivery of radiation to a
treatment area 40) may be initiated, such as to begin a treatment
session, or re-initiated after an interruption during a treatment
session if microcontroller 530 detects a "skin presence," e.g., by
determining that reflectance feedback signal 524 is above a
predefined skin/cornea threshold or within a predefined reflectance
window corresponding with skin. In such situation, control systems
18 may enable or power on treatment radiation source 14 (or control
other aspects of device 10) to begin radiation delivery to the
treatment area 40. The treatment may continue as long as
microcontroller 530 continues to detect a skin presence. The
treatment may be interrupted upon detection of a "possible cornea
presence" or upon other treatment interrupting events.
[0410] If microcontroller 530 determines that reflectance feedback
signal 524 is below the predefined skin/cornea or outside the
reflectance window corresponding with skin, microcontroller 530 may
detect a "possible cornea presence" (which is essentially a
detection of a non-skin surface, which could be a cornea, other
non-diffuse surface, or lack of a target surface, for example).
Control systems 18 may disable treatment radiation source 14 (or
control other aspects of device 10) in response to a possible
cornea presence detected by microcontroller 530, in order to
prevent a possible unintended eye exposure (and possible eye
damage).
[0411] The operation of sensor 114 is described below with
reference to FIGS. 49-50B. FIG. 49 illustrates light source 510 and
two different positions of detector 512. FIGS. 50A and 50B
illustrate the local surface normal directions for example corneas
of different shapes.
[0412] Detector 512 receives a larger amount of reflected light
(and thus generates a larger amplitude of signal 524) from diffuse
surface materials, due to light scattering, than from smoother,
more specular reflection materials. Skin is relatively diffuse,
while the corneal surface is generally smooth and specular, such
that the corneal surface has a much lower diffuse component of
reflection than the skin. This difference can be used to determine
whether detector 512 is positioned over an area of skin 32 or over
the cornea 500.
[0413] This technique of discriminating between diffuse and
specular materials using a single beam source 510 and single
detector 512 may assume that the angles between the target surface
normal and both the beam source 510 and detector 512 are known at
least to an extent. In particular, the angles at which beam source
510 and detector 512 are aligned relative to the target surface may
be selected such that the reflectance feedback signal 524 can be
reliably used to distinguish reflection off the skin from
reflection off the cornea, for a known range of corneal curvatures,
as discussed below with respect to FIGS. 50A and 50B.
[0414] In general, the local surface normal vector of a surface
(e.g., skin or corneal surface) will vary relative to a
larger-scale average surface normal, depending on the local
curvature of the surface. For example, near the edge of the cornea,
the local surface normal will be at least several degrees offset
from the normal vector at the center of the cornea, because the
cornea is a curved surface.
[0415] Assume a light beam source illuminates a surface at an
incidence of near-grazing (.about.0 degrees) and a detector views
this surface at near normal incidence (.about.90 degrees). For less
curved surfaces, the local surface normals are relatively close to
90 degrees, as shown in FIG. 50. In an extreme case shown in FIG.
50B, in which curvature provides a local surface normal of 45
degrees, a specular reflection propagates directly into the
detector. It may be assumed for the purposes of sensor 114 that the
exposed corneal surface forms an angle of less than 45 degrees with
the larger surface normal of the face (i.e., skin adjacent the
eye), such that a direct specular reflection from beam source to
detector does not occur for any practical configuration of sensor
114/device 10 relative to the face. It is also known that for a
normal eye, the most extreme angle near the corneal edge is less
than 40 degrees. (See, e.g., James D. Doss, "Method for Calculation
of Corneal Profile and Power Distribution", Arch Ophthalmol, Vol.
99, July 1981). Moreover, this angle quickly decreases to near 20
degrees within 60% of the central cornea region, i.e., the
curvature is not large near the cornea center. Therefore, for the
central 60% cornea region, the specular reflection from the cornea
will not be intercepted by the detector with a large margin.
[0416] Thus, assuming light source 510 is arranged at a
sufficiently low angle of incidence (e.g., .theta. shown in FIG. 49
between about 5 and 40 degrees), for all practical cases the cornea
will not reflect the light from light source 510 directly into
detector 512. Thus, for all practical cases, the cornea will
reflect less light from light source 510 into detector 512 than
will the skin. Thus, for practical cases, the cornea can be
distinguished from skin, assuming the proper signal amplitude
thresholds are utilized by microcontroller 530. Thus, to summarize,
assuming the proper orientation of light source 510 and detector
512, as well as the proper selection of threshold(s) for comparing
the amplitude of reflectance feedback signal 524, sensor 114 is
able to reliably discriminate between the skin and the cornea,
especially for the central cornea region which may be the most
important for vision.
[0417] It has been shown experimentally that the scattering
coefficient of skin dermis .mu.m.sub.s.sub.--.sub.skin is
substantially greater than that of the cornea
.mu.m.sub.s.sub.--.sub.cornea. In particular, the scattering
coefficient of skin dermis .mu.m.sub.s.sub.--.sub.skin.apprxeq.60
cm.sup.-1 for 500-nm wavelength (see Steven L. Jacques, "Skin
Optics", Oregon Medical Laser Center News, January 1998), whereas
the scattering coefficient of skin dermis
.mu.m.sub.s.sub.--.sub.cornea.apprxeq.10 cm.sup.-1 for 500-nm
wavelength (see Dhiraj K, Sardar, "Optical absorption and
scattering of bovine cornea, lens, and retina in the visible
region", Laser Med. Sci., 24(6), November 2009). Based on these
respective scattering coefficients, the expected diffused
reflectance of the cornea is about 8%, while the expected diffused
reflectance for a typical Fitzpatrick Type I to VI skin ranges from
70% to 10% respectively. Thus, for most skin types, the reflectance
contrast is large enough discriminating thee cornea from the skin,
again assuming the proper comparison thresholds or windows are
utilized by sensor 114.
Multi-Sensor Eye Safety System
[0418] In some embodiments, device 10 includes a multi-sensor
control/safety system that includes one or more eye safety sensor
114 and one or more skin contact sensors 104.
[0419] FIG. 51 illustrates an example multi-sensor control/safety
system 550 that includes one or more eye safety sensor 114 and one
or more skin contact sensors 104 arranged on or near device
application end 42. System 550 combines the functionality of eye
safety sensor 114 and skin contact sensor(s) 104 to provide more
reliable and/or redundant eye safety functionality as compared to
eye safety sensor 114 or skin contact sensor(s) 104 acting
alone.
[0420] System 550 may configured to control device 10 (e.g., turn
treatment radiation source 14 on/off) based on independent
determinations made by eye safety sensor 114 and skin contact
sensor(s) 104, in any suitable manner. The independent
determinations made by eye safety sensor 114 and skin contact
sensor(s) 104 may be based on comparisons of signals detected by
such sensors to respective thresholds, referred to herein as
"independent determination thresholds."
[0421] For example, system 550 may trigger a control signal to turn
on treatment radiation source 14 if either (a) eye safety sensor
114 determines a "skin presence" (discussed above), independent of
any determinations or signal analysis by contact sensor(s) 104, or
(b) all contact sensors 104 determine a contact status with the
skin, independent of any determinations or signal analysis by eye
safety sensor 114. Thus, system 550 may trigger a control signal to
turn off treatment radiation source 14 only if both (a) eye safety
sensor 114 determines a "possible cornea presence" (discussed
above), independent of any determinations or signal analysis by
contact sensor(s) 104, and (b) at least one contact sensor 104
determines a non-contact status with the skin, independent of any
determinations or signal analysis by eye safety sensor 114.
[0422] Alternatively, system 550 may trigger a control signal to
turn on treatment radiation source 14 only if both (a) eye safety
sensor 114 determines a skin presence (discussed above),
independent of any determinations or signal analysis by contact
sensor(s) 104, and (b) all contact sensors 104 determine a contact
status with the skin, independent of any determinations or signal
analysis by eye safety sensor 114. Thus, system 550 may trigger a
control signal to turn off treatment radiation source 14 if either
(a) eye safety sensor 114 determines a possible cornea presence,
independent of any determinations or signal analysis by contact
sensor(s) 104, or (b) any contact sensor 104 determines a
non-contact status with the skin, independent of any determinations
or signal analysis by eye safety sensor 114.
[0423] Alternatively or in addition, system 550 may be configured
to control device 10 (e.g., turn treatment radiation source 14 on
or off) based on inter-dependent analysis of signals from eye
safety sensor 114 and signals from skin contact sensor(s) 104. For
example, system 550 may utilize algorithms that analyze signals
detected by eye safety sensor 114 (e.g., reflectance feedback
signal 524 from detector 512) and signals detected by contact
sensor(s) 104 (e.g., signal 552 detected by contact sensor(s) 104)
to determine whether to trigger a particular control signal. For
example, such algorithms may incorporate thresholds that are lower
than the independent determination thresholds discussed above. Such
thresholds are referred to herein as "inter-dependent sensor
analysis thresholds."
[0424] To illustrate by example, system 550 may specify the
following independent determination thresholds: [0425] (a) 10 mV
eye safety threshold: eye safety sensor 114 determines a possible
cornea presence if the amplitude of reflectance feedback signal 524
falls below 10 mV, and [0426] (b) 50 pF contact sensor threshold:
contact sensor 104 determines a non-contact status if the amplitude
of contact sensor signal 552 falls below 50 pF.
[0427] Further, system 550 may specify the following
inter-dependent sensor analysis thresholds: [0428] (a) 15 mV eye
safety threshold for reflectance feedback signal 524, and [0429]
(b) 70 pF contact sensor threshold for signal 552.
[0430] System 550 may utilize an algorithm 154 that incorporates
the inter-dependent sensor analysis thresholds (15 mV and 70 pF).
For example, an algorithm may specify a control signal to turn off
treatment radiation source 14 if both (a) reflectance feedback
signal 524 falls below 15 mV and (b) contact sensor signal 552
falls below 70 pF.
[0431] As another example of controlling device 10 based on
inter-dependent analysis of signals from eye safety sensor 114 and
signals from skin contact sensor(s) 552, an algorithm 154 may
calculate an index, referred to herein as an "eye safety factor
index," or ESF index from reflectance feedback signal 524 and
contact sensor signal 552. The algorithm may weight reflectance
feedback signal 524 and contact sensor signal 552 in any suitable
manner. An example algorithm is provided as equation (1):
ESF index=signal 524 amplitude*W+signal 552 amplitude*W2 (1) [0432]
where W1 and W2 represent any suitable constants (including 0).
Another example algorithm is provided as equation (2):
[0432] ESF index=(signal 524 amplitude+C1)*(signal 552
amplitude+C2) (2) [0433] where C1 and C2 represent any suitable
constants (including 0).
[0434] Any other suitable algorithms may be used for calculating an
ESF index based on reflectance feedback signal 524 and contact
sensor signal 552.
[0435] ESF index may then be compared to a predefined threshold to
determine whether to trigger a particular control signal (e.g., to
turn off treatment radiation source 14), or compared to multiple
different predefined thresholds for triggering different control
signals. Such algorithms (using the same or different threshold
values) may be used for triggering any suitable control signals,
such as control signals for turning on treatment radiation source
14, turning on treatment radiation source 14, changing the current
treatment mode, or adjusting any controllable operational parameter
of device 10.
[0436] FIG. 52 illustrates an example method 600 for controlling
device 10 (e.g., controlling treatment radiation source 14) using a
multi-sensor control/safety system 550, according to certain
embodiments. At step 602, a user prepares for a treatment session
by selecting a treatment mode and/or other treatment parameters,
and places the application end 42 of device 10 against the
skin.
[0437] At step 604, system 550 determines whether the application
end 42 is correctly positioned against the skin for treatment,
e.g., using any of the techniques discussed above or any other
suitable technique.
[0438] If system 550 determines that the application end 42 is
correctly positioned against the skin for treatment, system 550 may
generate a control signal for beginning a treatment session
automatically or upon a defined user input (e.g., pressing a
treatment button), as indicated at step 606. Control systems 18 may
also generate feedback to the user indicating that treatment has
been initiated or that treatment is ready for initiation upon the
defined user input (e.g., pressing a treatment button).
[0439] Device 10 may then activate radiation source(s) 14 to
deliver beams 60 to the treatment area 40 to generate treatment
spots 62, as indicated at step 608. The user may operate device 10
in a gliding mode or a stamping mode, depending on the
configuration and/or selected treatment mode of device 10.
[0440] During the treatment, system 550 continually or repeatedly
determines whether the application end 42 is still correctly
positioned against the skin for treatment, as indicated at step
610. As long as system 550 determines that application end 42 is
correctly positioned against the skin for treatment, system 550 may
continue to generate control signals for continuing the treatment
session (i.e., such that control systems 18 continues to provide
beams 60 to generated treatment spots 62 in treatment area 40), as
indicated at step 612.
[0441] However, during the treatment, if system 550 determines that
application end 42 is not correctly positioned against the skin for
treatment (e.g., if system 550 determines that application end 42
is located over the cornea or moved out of contact with the skin),
system 550 may generate a control signal for automatically stopping
or interrupting the treatment session, e.g., by turning off or
disabling treatment radiation source 14), as indicated at step 614.
Control systems 18 may also generate feedback, e.g., audible or
visual feedback, to the user indicating the status of device 10.
For example, control systems 18 may provide general feedback
indicating that the treatment has been stopped or interrupted, or
may provide more specific feedback indicating the reason that the
treatment has been stopped or interrupted, such as feedback
distinguishing between eye detection, non-contact detection, and
device malfunction, for example.
[0442] System 550 may continue to monitor the positioning of
application end 42 at step 616. If system 550 determines that
application end 42 has again become correctly positioned against
the skin for treatment, system 550 may resume the treatment
session, e.g., by generating a control signal to resume treatment
(e.g., by turning on treatment radiation source 14), as indicated
at step 618, and resuming the generation of treatment spots 62 in
the skin, as indicated by the method returning to step 608.
[0443] The treatment session may end upon reaching a treatment
delimiter (such as discussed above regarding FIG. 48), or after a
predefined time, or based on any other parameters defining the
treatment session. It should be understood that this example and
FIG. 52 can apply to sensors other than contact sensor in a similar
manner.
Calibration of Eye Safety Sensor
[0444] In some embodiments, eye safety sensor 114 can be
individually calibrated to the current user of device 10. FIG. 53
illustrates an example method 650 for calibrating eye safety sensor
114 for one or multiple users. A calibration process is performed
at steps 652-660. At step 652, a user positions the application end
42 of device 10 against the user's skin, e.g., upon instruction
from device 10. Device 10 may instruct the user to position
application end 42 against a certain part of the body, e.g., the
face or back of the hand. Sensor 114 is activated and records a
reflectance/remittance feedback signal 524 at step 654. At step
656, the user may move the application end 42 of device 10 across
the skin, e.g., upon instruction from device 10. Sensor 114 may
continue to record reflectance feedback signal 524 at various
locations of application end 42 on the skin, at step 658.
[0445] At step 660, microcontroller 530 may analyze signal 524
recorded at steps 654, 658 to calibrate sensor 114. For example,
microcontroller 530 may execute one or more algorithms to determine
one or more appropriate threshold values (e.g., threshold voltages)
for distinguishing between skin and the cornea, e.g., for
determining a "skin presence" or "possible cornea presence," as
discussed above. Such threshold values may be stored by sensor 114
or control systems 18.
[0446] At step 662, the same user or a different user may initiate
device 10 for a treatment session. The user may identify him or
herself via a user interface 18, e.g., by scrolling and selecting
from a list of names, or entering a new name, at step 664. Device
10 may then determine whether eye safety sensor 114 has been
calibrated for that user, and if so, access the skin/cornea
determination thresholds stored for that user, at step 666. If the
user is a new user or eye safety sensor 114 has not been calibrated
for that user, device 10 may calibrate sensor 114 for that user to
determine and store skin/cornea determination thresholds for that
user, at step 668 (e.g., by leading the user through the
calibration process of steps 652-660).
[0447] After the skin/cornea determination thresholds for the user
have been accessed (or in the case of a new user, determined and
stored), the user may select various operational parameters and
begin a treatment session using device 10. During the treatment
session, at step 670, eye safety sensor 114 may continually or
repeatedly monitor the surface under application end 42 using the
user-specific thresholds accessed at step 666 or 668.
[0448] In other embodiments, device 10 may require eye safety
sensor 114 to be recalibrated before each treatment session.
Dual-Function Sensors
[0449] In some embodiments, in addition to providing eye safety
functionality, eye safety sensor 114 may also be used as a
displacement sensor, operating in a similar manner as discussed
above regarding single-pixel displacement sensor 100A, 100B, or
100C shown in FIGS. 37-39. For example, the functionality of eye
safety sensor 114 and displacement sensor 100A/100B/100C may be
integrated into a single sensor 100/114. Thus, a single light
source and single detector may be used to provide both the eye
safety and displacement monitoring functions described above. The
integrated displacement/eye safety sensor 100/114 includes one or
more microcontrollers or other processors for providing the
functionality of both sensors.
[0450] In other embodiments, device 10 may include both eye safety
sensor 114 and one or more displacement sensors 100 (e.g., one or
more single-pixel displacement sensors 100A/100B/100C and/or one or
more multi-pixel displacement sensors 100D), wherein eye safety
sensor 114 provides (in addition to its eye safety functionality)
device displacement monitoring functionality to supplement or
provide a backup to the displacement sensor(s) 100A/100B/100C.
Additional Embodiments and Features
[0451] Another example embodiment of device 10 is shown in FIGS. 54
and 55, and discussed below.
[0452] FIG. 54 shows an embodiment of device 10 that may be
approximately 12 cm long, having a generally rectangular
cross-section in the upper portion of approximately 2 cm.times.4
cm, and a nearly square cross-section in the lower portion of about
2 cm.times.2 cm. These dimensions and shapes are exemplary only, to
give a sense of the scale of the device and its comfort as a
hand-held device, and such dimensions and shapes are not intended
to be limiting in any manner.
[0453] The upper portion of housing 24 may house, for example, two
AA-size lithium polymer batteries 20, and user interfaces 28
including an on/off button 200 and operational indicator 54 such as
an LED, as well as a charger port 174 for recharging the batteries
20. The middle region of the device may house control electronics
30 for controlling the energizing of a laser 14 (which may include,
e.g., between one and four edge emitting laser diodes, which are
referred to hereinafter simply as laser 14 for clarity) and
responsive to a contact sensor 104 and either a displacement sensor
100 or a motion/speed sensor 102, depending on the particular
embodiment. This location of electronics 30 allows for the
electronics 30 to be thermally coupled to a heat sink 36, in this
case a thermal mass (for example, a cylinder of copper) located in
the lower portion of the device.
[0454] In an embodiment, to prevent the laser 14 from overheating,
the laser may be arranged in direct thermal contact with the
thermal mass heat sink 36. During operation, the waste heat from
the edge emitting laser diode 14 is conducted into the mass 36. For
example, the thermal mass 36 can be machined out of copper in such
a way that the laser 14 is pressed into an opening in the copper
cylinder, and in some embodiments the mass 36 can serve as one
electrical conduit for connecting the laser drive circuit 30 to the
edge emitting laser diode 14.
[0455] The displacement sensor 102 or motion/speed sensor 102 may
be located very close to the treatment tip 42 of the housing 24,
generally adjacent to the edge emitting laser diode 14 as shown in
FIG. 54. The contact sensor 104 may also be located at or near the
device tip 42, and for example may comprise a capacitive sensor
partly or wholly surrounding a window 44 through which a laser beam
or beams 60 are delivered toward the skin 40, although mechanical
sensors are also acceptable in some embodiments. The window 44 may
be selected from a group comprising sapphire, quartz, diamond, or
other material transparent at the frequency of the edge emitting
laser diode and having a good thermal coefficient. In some
embodiments, the window 44 is placed in contact with the skin
surface 38 during treatment.
[0456] Referring next to FIG. 55, an example operational schematic
of device 10 of FIG. 54 is shown in block diagram form. At least
one microprocessor 150 receives power from batteries 20 or other
power supply. In embodiments in which rechargeable batteries are
used, a charger circuit 176 and charging port 174 may be provided,
with the charging port 174 also receiving control signals from
processor 150 to prevent overcharging and detect operational
errors.
[0457] On on/off button 200 may enable operation of the circuitry,
such that when power is applied to the microprocessor 150, an
indicator light or LED 54 is illuminated. A contact sensor 104
detects contact with a user's skin, as discussed above, while
either a displacement sensor 100 or a motion/speed sensor 102
detects displacement or motion of the device across the skin at a
displacement or rate deemed sufficient to prevent multiple firings
of laser 14 in too-close proximity to one another, thus preventing
overlap of successive treatment spots 64. The contact sensor 104
and displacement sensor 100 or motion/speed sensor 102 may provide
input to the processor 150, which allows the processor to energize
a laser drive circuit 30 safely and effectively. When permitted by
the processor 150, the laser drive circuit 30 energizes edge
emitting laser diode 14, which causes a pulsed beam 60 to be
emitted through the outlet window 44 described above.
[0458] In one embodiment, the non-ablative fractional device 10 may
incorporate, for example, a mid-infrared edge emitting laser diode
in the wavelength range of 1.4-1.6 microns, such as those available
from SemiNex Corporation (Peabody, Mass.). These very small (4
mm.times.7 mm.times.8 mm) laser devices produce about 6 watts of
laser power. Device 10 may set a pulse duration of about 5 ms,
which may produce about 30 mJ of energy per pulse. The laser can
operate at a pulse repetition rate of about 20 Hertz, for example.
According to these example parameters, the diode voltage may be
about 1.7 volts at a current of about 10 amperes, resulting in an
efficiency of about 35%. The output wavelength may be, for example,
1.47 microns (SemiNex Part No. C-1470-6-95).
[0459] Beam propagation according to such embodiments may be
simpler and more reliable than in conventional devices. As
described above, the direct laser output of a typical diode laser
is highly divergent in the fast axis, with considerably lower
divergence in the slow axis. In certain conventional devices, a
cylindrical microlens or other optic may be placed in the optical
path, very close to the emitter surface (or "facet"), to collimate
or reduce the divergence of the beam in the fast axis. Further in
the optical path, a second cylindrical lens or other optic may be
positioned orthogonal to the first lens, to collimate or reduce the
divergence of the beam in the slow axis. This relatively complex
arrangement is used in certain conventional devices because it
allows the beam to be propagated through various beam-scanning
optics. However, in such conventional devices, careful and
laborious (and costly) positioning of the lenses or other optics
may be necessary to bring the beam to focus on the skin at the
output window, wherein the emitter facet is approximately 1 micron
by 100 microns, and the exit window has an area of one square
centimeter or more.
[0460] In contrast, certain embodiments disclosed herein eliminate
the microlenses or other optics used in such conventional devices,
and instead locate the diode laser emitter facet (i.e., emitter
surface) very close to the skin surface (e.g., with only a thin
window between the diode laser emitter facet and the skin, and rely
on the divergence and propagation characteristics of the unmodified
beam 60 to create an appropriately sized treatment spot 62 and MTZ
64 on the skin. For example, a 1-micron by 95-micron beam with
divergence of about 28 deg FWHM by about 6 deg FWHM, respectively,
may expand to an approximately circular beam of about 120 microns
at a distance of 240 microns from the emission facet. Using an
approximately 0.14 mm thick window with its input face about 100
microns from the emitter facet, and its output face touching the
skin at a distance of about 240 microns from the emitter facet may
produce a treatment spot 62 on the skin surface of about 120
microns in diameter. With a device glide speed of about 2 cm/s and
a 5-ms pulse duration, the treatment spot 62 becomes an oval of
about 120 .mu.m by 220 .mu.m in diameter.
[0461] While some embodiments omit lenses of any type (as discussed
above), in some embodiments device 10 may include a simple lens for
beam shaping while still benefiting from various advantageous
aspects discussed above. For example, if a larger treatment spot 62
or MTZ 64 is desired, a diverging lens can be used; or,
alternatively, the edge emitting laser diode 14 can be moved
slightly further from window 44, for example by an additional 100
microns, allowing a longer propagation path for the beam 60 before
it reaches the skin. If a smaller treatment spot 62 or MTZ 64 is
desired, a simple converging lens can be used. Utilizing example
treatment parameters described more fully below, the percentage of
area treated may be between about 1% and about 10%, e.g., about 5%
of the skin surface if the treatment spot diameter is about 65
microns, and between about 10% and about 30%, e.g., about 20% of
the skin surface if the treatment spot diameter is about 130
microns, when, for example, device 10 is used daily for about one
month.
[0462] In some embodiments, and for particular operational
parameters, the beam may have an elliptical shape of approximately
150 .mu.m by 250 .mu.m at a depth into the skin of about 260 .mu.m,
assuming the device is held stationary on the skin. When the device
is glided across the skin, this elliptical shape becomes a roughly
circular zone of about 250 .mu.m in diameter. This re-shaping of
the beam at depth occurs due to the movement of the device across
the skin. In some embodiments, the user may be instructed to move
device 10 in a generally side-to-side or serpentine manner, e.g.,
as shown in FIG. 8C, 8D, 8F, or 8G, for example.
[0463] The simplicity of certain embodiments disclosed herein may
reduce or minimize the electrical load on the battery/batteries 20,
which may allow for sufficient charge from a single AA-sized
battery. To provide a peak current requirement of, for example, 10
amps, two AA-sized batteries may be used in some embodiments.
Operation of an example embodiment of device 10 at, for example, 6
watts of optical output power for 120 seconds may requires a charge
of only 34 mAh, whereas a typical single AA-sized lithium polymer
battery has a charge of about 600 mAh. For example, an IMR 14500
rechargeable battery available from www.lighthound.com has a
continuous discharge current capability of 3 amps, or 6 amps for
two batteries in parallel. For an example laser pulse duration of 5
ms (and an example duty cycle of about 10%), this battery pair can
readily produce current pulses of 10 amps or more. A very low
current battery-charger port 174 may be included at the back end of
device 10, as shown in FIG. 54.
[0464] Some embodiments of device 10 may include a motion/speed
sensor 102 comprising an accelerometer for determining motion of
the device 10. However, the operation of the accelerometer in
device 10 may differ significantly from those found in the
conventional devices. For an effective operation of certain
embodiments of device 10, absolute location relative to the prior
laser pulse is not important as long as the new location is at a
location different from the prior laser pulse. Thus, in such
embodiments, as long as a detectable signal from the accelerometer
confirms that device 10 is undergoing acceleration, and contact
sensor 104 confirms that device 104 is in contact with the skin 40,
the next laser pulse can be at any location. One example of a
suitable accelerometer is the LIS305DL available from ST
Microelectronics (Santa Clara, Calif.), which is a three axis
linear accelerometer measuring about 3 mm by 5 mm by 0.9 mm in size
and can be readily mounted by any conventional means at or near the
tip 42 of device 10 and electrically connected to processor 150. In
an alternative embodiment, the motion/speed sensor can be a
vibration and tilt sensor such as a SignalQuest SQ-MIN-200. Other
embodiments of device 10 include a displacement sensor 100 (e.g.,
as discussed above in greater detail) instead of a motion/speed
sensor 102 or accelerometer.
[0465] To reduce or minimize the size and power consumption of
device 10, some embodiments use a thermal mass 36 to mitigate
temperature rise in the device. The mass 36 can be, for example,
solid copper which has a volumetric heat capacity of 3.45 joules
per centimeter cubed per degree centigrade. For an example
embodiment operating with two lithium AA batteries operating at 3.5
V and an average current of 1 A (e.g., 10 A at 10% duty cycle) for
two minutes, the total heat generated is slightly over 400 joules.
Certain edge emitting laser diodes can operate safely with a
temperature rise of about 20.degree. C. or more; thus the volume of
copper required to effect a thermal mass temperature rise of
20.degree. C. is about 6 cubic centimeters. This corresponds to a
14 mm diameter rod about 4 cm in length, or approximately the
diameter of an AA battery with slightly shorter length.
Alternatively, the mass 36 can comprise a sealed thermally
conductive cylinder or other shape container filled with a liquid
such as water, or a phase change material such as a wax with a
melting point of around 30.degree. C. In some embodiments, or for
some patients, it may be desirable to cool or chill device 10, or
at least thermal mass 36, before using device 10. For example, if
mass 36 comprises a sealed container filled with water, freezing
the water in the container can offer the ability to absorb
substantially more energy without any temperature increase during
the melting process.
[0466] By locating the laser control electronics 30 at the opposite
end of the copper cylinder from the laser 14, the waste heat from
electronics 30 (included in the above total) is also deposited in
the copper mass 36. Once the device thermal mass 36 has reached
approximately 40 deg C. (or other predefined temperature), the
microprocessor 150 may prevent further operation of device 10 until
room temperature is once again established in the thermal mass
36.
[0467] In a particular embodiment, device 10 may be designed to
produce a 30-mJ pulse in 5 ms, forming a treatment spot 62 of about
120 .mu.m by 220 .mu.m at the skin surface. This energy is
sufficient to produce denatured skin to a depth of at least 250
.mu.m, which is generally comparable to certain office-based
fractional treatment devices. An embodiment of device 10 configured
for non-ablative fractional treatment may be used in the following
manner, as an example. The on/off button 200 is pressed to turn the
device on. The LED 54 is energized that is visible to the user,
indicating that device 10 is ready for a treatment to be performed.
The output window 44 of device 10 is then touched to the skin in
the area to be treated, and device 10 is moved back and forth
across the skin surface 38 at a manual glide speed generally in the
range of about 1-2 cm/s, although in some applications the manual
glide speed and/or the pulse repetition rate or duty cycle can vary
considerably, as discussed further below. When contact with the
skin surface 38 is verified by a contact sensor 104, and
appropriate displacement or acceleration of tip 42 is sensed by
displacement sensor 100 or motion/speed sensor 102 or
accelerometer, pulsed laser beams 60 are emitted through the window
44 to the skin, and the LED 54 on device 10 flashes synchronously
with the laser emission. If the tip 42 is (a) not moving; (b)
failing to achieve sufficient displacement, motion, or acceleration
across the skin; (c) moving too slowly or too quickly; (d) moving
but undergoing no acceleration for an embodiment with an
accelerometer; or (e) not in contact with the skin, device 10 may
prevent pulsing of the laser. Condition (d) may occur if device 10
is moved in a straight line for, e.g., 5-10 centimeters at constant
speed. If device 10 is moved back and forth across the skin, or
varies moderately from a straight line, tip 42 will undergo
acceleration at all times, thus enabling pulsing of the laser.
[0468] In some embodiments or applications, a manual glide speed of
about 2 cm/s or 1 inch/s can be treat an area of about 20-30
cm.sup.2 in a treatment session of about two minutes. This
treatment area may be sufficient for coverage of the two
periorbital regions when used as described above. At an example
pulse repetition rate of about 10 Hz, roughly 50 MTZs are created
in an area of roughly one square centimeter in about five seconds.
In a month of once-daily treatments, about 1500 MTZs/cm.sup.2 are
created, which may be generally comparable to certain office-based
systems.
[0469] After a predefined period of operation, e.g., two minutes,
device 10 may automatically turn itself off, and may remain
inoperable for some defined time period or until certain
condition(s) are present, e.g., until the device heat sink 36 has
returned to room temperature or other selected temperature, or
until the battery 20 has substantially fully recharged, or both. In
one embodiment, a full recharge of battery 20 takes approximately
one hour, whereas heat sink 36 may return to room temperature more
quickly.
[0470] In some alternative embodiments or application, device 10
can be operated at with somewhat faster manual glide speeds and
higher pulse repetition rates to allow for greater areal coverage
in a particular time period time. For example, for a pulse
repetition rate of 20 Hz, operating for a period of two minutes,
with a manual glide speed of about 2 cm/s, certain embodiments of
device 10 can cover an area of 40-60 cm.sup.2. When applied twice
daily for thirty days, e.g., the total density of MTZs may be
greater than or equal to the MTZ density achieved with certain
office-based fractional treatment systems in a single monthly
treatment, for example.
[0471] If greater coverage per unit of time is desired while
maintaining a sufficient density of MTZs, the pulse repetition rate
of the edge emitting laser diode may be increased in some
embodiments, e.g., to approximately 30 Hz rather than 10 or 20 Hz,
with a manual glide speed of about 2.5 cm/s, or about 1 inch/s. In
such embodiments, approximately 300 MTZs may be deposited in an
area of about 6 square centimeters, or about one square inch, for a
density of about 50 MTZs/cm.sup.2, but in about one-third the time
compared to a pulse repetition rate of 10 Hz. This may allow
treatment of each periorbital region in about 10-15 seconds, and a
full face in about five minutes. Appropriate reductions can be made
for automatic turn-off time after a cessation of motion; for
example, within 30 ms of motion cessation for a 30 Hz device,
versus 100 ms for a 10 Hz device. It will be appreciated that the
foregoing duty cycles and pulse repetition rates are examples only,
and significant variation is permitted in other embodiments.
[0472] In at least some embodiments of device 10, eye safety is
assured based on contact sensor 104. Mid-infrared lasers are
frequently referred to as "eye-safe" lasers, because light in the
wavelength region of 1.4-1.6 microns is absorbed in the cornea and
cannot pass through the vitreous humor of the eye. However, with
sufficient fluence, one or more treatment spots could conceivably
be created on the cornea unless appropriate safety measures are
incorporated. Certain embodiments of device 10 (e.g., direct
exposure embodiments using an edge emitting laser diode as the
radiation source 14) utilize a rapidly diverging beam, such that
the laser fluence at the cornea surface is insufficient to cause
any damage unless the treatment tip 42 of device 10 is placed
within approximately 5 mm of the cornea. Nonetheless, to ensure
safe operation, certain embodiments include one or more contact
sensors 104 at the device tip 42, which is/are connected to
processor 150, to enable laser emission only when device tip 42 is
in contact with the skin. Thus, for certain embodiments of device
10, the risk of eye injury may be substantially eliminated unless
device 10 was placed directly on the eyeball, and then moved along
the eyeball surface while maintaining contact. Other embodiments
may alternatively, or in addition, include an eye safety sensor
114, e.g., as described above regarding FIGS. 48-51, which may
further improve the eye safety aspect of device 10.
[0473] In some embodiments, e.g., where device 10 is configured for
providing non-ablative fractional treatment, the operation of
device 10 may allow for the introduction of topical agents through
the stratum corneum and epidermis without providing an easy path by
which undesirable bacteria can enter the body. It is well known
that the uppermost layers of skin, namely the stratum corneum at
the very top and epidermis immediately underneath, provide a strong
and important "wall" protecting the underlying dermis and the blood
vessels contained therein from the outside world. In particular,
these upper layers greatly impede the ability of bacteria to reach
the dermis, which if allowed in could potentially infect the entire
body through the blood supply.
[0474] This same "wall," however, also impedes or prevents various
desirable topical agents, such as anesthetics, moisturizers,
wrinkle reducers (whether of the neurotoxin type such as Botox, or
collagen growth stimulating serums, etc.) and similar agents from
reaching the dermis and achieving the desired benefit.
[0475] Various known methods exist for mechanically breaching this
barrier. For example, rollers with dozens or hundreds of very fine
needles have been employed, with the needles of perhaps 200 microns
or more in length, to break through to the dermis; and more
recently, laser-drilled micro-holes of perhaps 100 microns in
diameter and up to a millimeter or more in depth have been
successfully created using so-called fractional ablative lasers.
However, while the holes created by these prior art techniques
facilitate transport of a topical into the dermis, they also
provide a ready path for bacteria to invade the body.
[0476] In contrast, the creation of microthermal zones of denatured
skin using certain embodiments of device 10 may provide a
reasonable compromise between increasing transport of a variety of
topical agents into the dermis while still providing a barrier to
bacteria. The column of denatured skin formed by a microthermal
zone 64 has increased permeability to surface-applied agents, and
thus allows an increased concentration of an applied topical to
reach the dermis. At the same time, the denatured skin of the MTZ
64 may continue to provide a physical barrier to bacteria.
* * * * *
References