Note: Descriptions are shown in the official language in which they were submitted.
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APPARATUS AND METHOD FOR STIMULATING HAIR GROWTH AND/OR
PREVENTING HAIR LOSS
Cross-Reference
Some embodiments of the present invention relate to methods and apparatus that
were disclosed in PCT/IB2012/057041 which (i)
was filed on December 12, 2012;
(ii) was published on June 13, 2013 as WO/2013/084189; and (iii) is
incorporated herein
by reference in its entirety. In some embodiments, any feature or combination
of features
described in the present document may be combined with any feature or
combination of
features described in application PCT/IB2012/057041. In some
embodiments, any
feature or combination of feature(s) disclosed in application
PCT/IB2012/057041 may
be modified - e.g. electrode-needles thereof may be configured so they are not
as sharp,
and/or so that they are non-wounding - e.g. configured not to penetrate (e.g.
under
normal use) into the dermis.
FIELD AND BACKGROUND OF THE INVENTION
The present invention, in some embodiments thereof, relates to a device and
method for stimulating skin and, more particularly, but not exclusively, to a
device and
method for directly stimulating the skin below the surface of the scalp to
promote hair
growth.
SUMMARY
Apparatus for treating the scalp comprising:
a plurality of ion-releasing electrode protrusions configured so that when
first and
second of the protrusions are simultaneously in contact with human skin, at
least
partially-ionic current flows between the first and second electrode
protrusions via the
skin so as to deposit ions, released from the first and/or second electrode
protrusions, on
the skin.
Apparatus for treating the scalp comprising:
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a plurality of ion-releasing electrode protrusions configured so that when
first and
second of the protrusions are simultaneously in contact with human skin, at
least
partially-ionic current flows between the first and second electrode
protrusions via the
skin so as to deposit (e.g. sequentially) on the skin, a ion and a counter-ion
thereof (for
example, to cycle back and forth between a first-mode where the ion is
deposited
without the counter ion and a second mode where the counter ion is deposited
without
simultaneously depositing the ion) , the ion and counter-ion being released
from the first
and/or second electrode protrusions. In some embodiments, a separation
distance
between the first and second protrusions is at most 1 cm or at most 5 mm.
Embodiments of the invention relate to a device and method whereby the scalp
is
rapidly and repeatedly touched by ion-releasing electrodes. During each 'ion-
depositing
electrode-scalp contact event' an electrode (e.g. through which externally
generated
electrical current flows) is very briefly brought into and out of contact with
the scalp -
e.g. in contact with the scalp for at most 100 milliseconds. During each brief
contact
event, the electrode is briefly brought into and out of contact with the scalp
so as to
deposit metal on the scalp to form a small (e.g. at most 15 mm2 in area) metal-
deposition island on the scalp. In some embodiments, each brief contact event
is
effective to apply a significant amount of highly-localized pressure, e.g at
least 0.5
megapascals [MPa] localized over a contact area of at least 0.1 mm2 and at
most 10
mm2. The rapid application of non-wounding but significant pressure subjects
the scalp
to a 'micromassage.'
The method is performed so that: (i) a large number of such electrode-events
are
sequentially performed within a relatively short period of time; (ii) at least
two types of
metal-deposition islands are formed on the scalp (e.g. a first type comprising
zinc and a
second type comprising copper); and (iii) both types of metal-deposition
islands are
distributed over a significant portion of the scalp. As discussed below, it is
possible to
quantify the extent of distribution of metal-islands on the scalp and the
proximity of first
and second types of metal islands (e.g. 'cathode-islands' and 'anode-
islands'), in terms of
'scalp patches.'
Not wishing to be bound by theory, it is believed that the deposition of a
relatively large number of very small but distinct metal-ion-deposition-
islands on the
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user's scalp forms a significant number of 'micro-battery-cell' on the user's
scalp when
both cation islands and anion islands are distributed over a region of the
scalp. It is
believed that after deposition of the islands, small electrical currents may
be sustained
between the distinct deposition islands (e.g. due to proximity of distinct
cathode-islands
and anode-islands) along the user's scalp for some period of time (e.g. at
least hours). It
is believed that the combination of the time-sustained electrical stimulation
together with
the mild trauma of the micro-massage obviates the need to employ wounding-
based
techniques to stimulate the scalp.
Although skin-wounding stimulates cell-growth in the skin (and possibly hair-
growth) by inducing a biological 'wound-healing' process, certain users may
consider
wounding devices as invasive and unpleasant to use. It is believed that the
presently-
disclosed ion-delivering micro-massage obviates the need for a more severe
treatment
regimen based on wounding, while still combating baldness.
When metallic-ions are 'released from' an electrode this is in contrast with
pre-
applying an ion-containing topical agent (e.g. an ion-containing liquid or
cream or gel)
to the skin and then using an electrode to drive the ions into the skin. When
metallic-
ions are 'released from', the source of the metallic ions is from the
electrode itself. The
released metal-ions are provided from an interior of the electrode (e.g. from
a reservoir
disposed within the electrode) or from actual material of the electrode (i.e.
the electrode
is at least partially constructed from the metal which is then released) or
from an
'integrally-formed' coating on the electrode - i.e. the electrode is pre-
coated with the
metal so that the metal coating is integrally formed with the electrode and
then metal of
this coating is released.
By 'releasing' metallic ions from the electrode rather than relying on a
topically-
applied ion-containing flowable-fluid (e.g. liquid, cream, gel), it is
possible to deliver
distinct ion-deposition metal-ion deposition islands. After treatment, small
electrical
currents may flow between these metal-deposition islands to electrically
stimulate the
skin after the electrode-contacting events have ceased, thereby providing a
sustained
effect.
A number of techniques are disclosed herein for rapidly bringing electrode
into
and out of contact with the scalp. In one example, a plurality of electrode-
protrusions
(e.g. having a rounded tip) are disposed around a roller. As the roller is
rolled over the
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surface of the skin, the electrodes are briefly brought into contact with and
out of contact
with the skin so that a large number of very brief electrode contact events
are performed.
A second example relates to a motorized device. In this second example,
electrodes (eg.
having a rounded tip) are rapidly, reciprocally and vertically brought into
contact and out
of contact with the scalp.
Despite the very-brief contact periods (i.e. less than 0.1 seconds or even
less)
between each electrode and the scalp, a therapeutically effective amount of
metallic-ions
may be deposited in each treatment island. Towards this end, an external
electrical
power source may boost a rate of ion-delivery to each treatment island,
instead of
relying only on a galvanic potential between electrodes of different polarity.
Not wishing
to be bound by theory, externally-driving ion deposition on the scalp may,
once again,
obviate the need for a more mechanically-aggressive wounding-based treatment
where
most electrode-contact events lead to penetrating of the dermis.
It is now disclosed a method of treating or preventing a hair-condition of a
user,
the user's scalp dividable into a scalp-patch-set of n millimeter (mm) x n
millimeter
(mm) non-overlapping scalp patches, where n a positive number having a value
of at
most 5. The method comprises subjecting the user's scalp to at least q
distinct electrode-
scalp contact events within a time-interval of at most one minute and
dividable into m
non-overlapping equal-duration sub-intervals covering the time-interval, m
begin a
positive integer having a value of at least 5, q being a positive integer
having a value of
at least 200. For the non-limiting example where m is 5, the m equal-duration
sub-
intervals are [0,12 seconds], [12 seconds,24 seconds], [24 seconds, 36
seconds], [36
seconds,48 seconds], and [48 seconds, 60 seconds]. Since every moment within
the one-
minute time interval i within one of the sub-intervals, the sub-intervals may
be said to
collectively 'cover an entirety of the time-interval.
In some embodiments, for at least a majority of the electrode-scalp contact
events, no electrode of the event enters into the dermis;
In some embodiments, a duration of each electrode scalp contact event is at
most
100 milliseconds - i.e. for each electrode-scalp no more than 100 milliseconds
elapses
between (i) a time when the electrode is brought into contact with the scalp;
and (ii) a
time when the electrode is taken out of contact with the scalp.
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In some embodiments, an electrode-scalp contact area for each electrode-scalp
contact event is at most 10 mm2.
In some embodiments, for each electrode contact event, an electrical current
flows between the electrode and the scalp so as to deposit electrode-released
ions of a
first metal or of a second metal on the scalp, thereby forming a respective
metal-ion-
deposition island on the user's scalp. Thus, each contact event deposits
either a first
metal (e.g. zinc) and a second metal (e.g. copper) but not both. Other metals
other than
the first and second metal may additionally be deposited along with the first
or the
second metal.
In some embodiments, for each of the non-overlapping equal-duration sub-
intervals, at least p electrode-scalp contact events occur, p being a positive
integer
having a value of at least 1.
In some embodiments, at least 5% of the events are first-metal-depositing and
at
least 5% of the events are second-metal-depositing.
In some embodiments, at least one first-metal-deposition-island and at least
one
second-metal-deposition-island are both respectively and distinctly formed on
each n
mm x n mm scalp-patch selected from a 10-member scalp-patch sub-set of the
scalp-
patch set.
In some embodiments, the islands may be 'distinct' from each other for some
the islands may form a 'bridge' between the formerly-'distinct' islands. This
does not
detract from the fact that for at least some period of time, the islands were
'distinct' from
each other.
In some embodiments, during at least some of the electrode-scalp contact
events,
externally-generated electrical current (i.e. as opposed to galvanic current)
is forced
between the electrode and the scalp (for example, between two different
electrodes that
are simultaneously in contact with the scalp where due to an externally-
maintained
electric potential difference between the electrodes, electrical current flows
therebetween
via the scalp) so as to deposit or increase a deposition-rate of electrode-
released ions of
the first or second metal onto the scalp. Some galvanic current may be
present, but the
externally-generated electrical current may boost a rate of metal-ion-
deposition.
A cosmetic method of treating or preventing a hair-condition of a user
comprising: subjecting the user's scalp to at least 200 distinct electrode-
scalp contact
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events during a time-interval of at most one minute and dividable into 5 non-
overlapping
equal-duration sub-intervals covering the time-interval, method performed such
that: i.
for at least a majority of the electrode-scalp contact events, no electrode of
the event
enters into the dernfis; ii. a duration of each electrode contact event is at
most 100
milliseconds; and iii. for each electrode contact event, an electrical current
flows
between the electrode and the scalp so as to deposit electrode-released ions
of a first
metal or of a second metal on the scalp, thereby forming a respective metal-
ion-
deposition island on the user's scalp.
BRIEF DESCRIPTION OF THE DRAWINGS
Some embodiments of the invention are herein described, by way of example
only, with reference to the accompanying drawings and/or images. With specific
reference now to the drawings and/or images in detail, it is stressed that the
particulars
shown are by way of example and for purposes of illustrative discussion of
embodiments
of the invention. In this regard, the description taken with the drawings
and/or images
makes apparent to those skilled in the art how embodiments of the invention
may be
practiced.
In the drawings:
FIGS. 1-5 relate to a device or portion(s) thereof for depositing metal ions
on the
scalp, for example, to treat a hair-condition such as baldness.
FIGS. 6 and 9 illustrate patterns of metal-ion-deposition on the scalp.
FIG. 7 illustrates a timeline showing where electrodes are brought into
contact
and out of contact with the scalp.
FIG. 8 illustrates a contact-event between electrodes and skin (e.g. of the
scalp)
wherein the electrodes do not penetrate into the dermis and ions are deposited
on the
skin (e.g. of the scalp).
FIGS. 10-12 relate to additional embodiments of treating the scalp.
FIGS. 13A-13B describe some experimental results.
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DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
The invention is herein described by way of example only, with reference to
the
accompanying drawings. With specific reference now to the drawings in detail,
it is
stressed that the particulars shown are by way of example and for purposes of
illustrative
discussion of the preferred embodiments of the exemplary system only and are
presented
in the cause of providing what is believed to be a useful and readily
understood
description of the principles and conceptual aspects of the invention. In this
regard, no
attempt is made to show structural details of the invention in more detail
than is
necessary for a fundamental understanding of the invention, the description
taken with
the drawings making apparent to those skilled in the art how several forms of
the
invention may be embodied in practice and how to make and use the embodiments.
For brevity, some explicit combinations of various features are not explicitly
illustrated in the figures and/or described. It is now disclosed that any
combination of
the method or device features disclosed herein can be combined in any manner ¨
including any combination of features ¨ and any combination of features can be
included
in any embodiment and/or omitted from any embodiments.
Definitions
For convenience, in the context of the description herein, various terms are
presented here. To the extent that definitions are provided, explicitly or
implicitly, here
or elsewhere in this application, such definitions are understood to be
consistent with
the usage of the defined terms by those of skill in the pertinent art(s).
Furthermore,
such definitions are to be construed in the broadest possible sense consistent
with such
usage.
In the present disclosure 'electrical circuitry' or 'electronic circuitry' is
intended
broadly to describe any combination of hardware, software and/or firmware.
Electronic circuitry may include may include any executable code module (i.e.
stored on a computer-readable medium) and/or firmware and/or hardware
element(s)
including but not limited to field programmable logic array (FPLA) element(s),
hard-
wired logic element(s), field programmable gate array (FPGA) element(s), and
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application-specific integrated circuit (ASIC) element(s). Any instruction set
architecture may be used including but not limited to reduced instruction set
computer
(RISC) architecture and/or complex instruction set computer (CISC)
architecture.
Electronic circuitry may be located in a single location or distributed among
a plurality
of locations where various circuitry elements may be in wired or wireless
electronic
communication with each other.
When metallic-ions are 'released from' an electrode this is in contrast with
pre-
applying an ion-containing topical agent (e.g. an ion-containing liquid or
cream or gel)
to the skin and then using an electrode to drive the ions into the skin. When
metallic-
ions are 'released from', the source of the metallic ions is from the
electrode itself. The
released metal-ions are provided from an interior of the electrode (e.g. from
a reservoir
disposed within the electrode) or from actual material of the electrode (i.e.
the electrode
is at least partially constructed from the metal which is then released) or
from an
'integrally-formed' coating on the electrode - i.e. the electrode is pre-
coated with the
metal so that the metal coating is integrally formed with the electrode and
then metal of
this coating is released.
By 'releasing' metallic ions from the electrode rather than relying on a
topically-
applied ion-containing flowable-fluid (e.g. liquid, cream, gel), it is
possible to deliver
distinct ion-deposition metal-ion deposition islands. After treatment, small
electrical
currents may flow between these metal-deposition islands to electrically
stimulate the
skin after the electrode-contacting events have ceased, thereby providing a
sustained
effect.
A 'counter-ion' is an ion with a different electrochemical potential
relatively to
the skin.
Typically, an ion is a 'metal ion.'
A 'CYLINDRICAL ROLLER' is either continuous -- full cylinder -- OR a series
of discs along a common central axis (straight or conformable) where the
circumferences
of the discs are substantially disposed along a common 'geometrical-construct'
cylinder')
A 'thin disc' having a thickness of at most 1 mm or at most 0.75 mm or at most
0.5 mm or at most 0.25 mm or at most 0.1 mm and/or a diameter of at least 10
mm, or at
least 30 mm or at least 40 mm or at least 50 mm or at least 60 mm or at least
70 mm
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Figure 1 is an illustration of an exemplary device 100 for promoting hair
growth,
in accordance with an exemplary embodiment of the invention. FIG. 2 is a close-
up of a
portion of the device of FIG. 1. As illustrated in FIGS. 1-2, protrusion-
electrodes 102
are arranged along the circumference of at least one disc 104, for example, 2,
4, 6, 8, or
other smaller, intermediate or larger numbers of discs 104 are used. In FIG.
1, six discs
labeled as 104A-104F, are illustrated. The diameter of discs 104 is, for
example, about 2
cm, about 4 cm, about 6 cm, or other smaller, intermediate or larger diameters
are used.
The thickness of discs and/or electrodes is, for example, about 0.05 mm, about
0.1 mm,
about 0.15 mm, or other smaller, intermediate or larger thickness are used.
In some embodiments, the protrusion-electrode as 'ion-releasing' as discussed
below. Nevertheless, this is not a limitation - in fact, any feature or
combination or
feature(s) or embodiment referring to or requiring 'ion-releasing electrode'
may, in other
embodiments, also refer to an electrode that is not ion-releasing in any
context in the
present document.
In an exemplary embodiment of the invention, electrodes 102 and/or discs 104
are arranged to allow existing hair on the scalp to be displaced (e.g.,
brushed) away from
the electrodes during use. Optionally, discs 104 are arranged parallel to one
another, to
allow hair to be brushed between the discs. Discs 104 are located about 1 mm
apart, 3
mm apart, about 5 mm apart, or other smaller, intermediate or larger distances
are used.
The shapes of the protrusions 102 are non-limiting -- other examples (which
may
be used in any embodiment including but not limited to roller-relating
embodiments,
scalp-brush related embodiments)
In an exemplary embodiment of the invention, electrodes 102 are coated by at
least one metal. Alternatively, electrodes 102 are made from the metal.
In one non-limiting example related to FIGS. 1-2, a first set of discs (e.g.
discs
104A, 104C, and 104E) are coated with a cation (e.g. copper) while a second
set of discs
(e.g. 104B, 104D and 104F) are coated with an anion (e.g. zinc). In this
situation, (i)
metal deposition ions comprising the cation are formed contact of electrodes
by discs of
the first set and (ii) metal deposition ions comprising the anion are formed
contact of
electrodes by discs of the second set.
As will be discussed below, the alternating cation/anion disc pattern
described in
the previous paragraph may be useful for ensuring that, after treatment, metal-
ion-
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deposition islands comprising the cation are relatively proximate on the scalp
to metal-
ion-deposition islands comprising the anion. This may be useful for depositing
miniature
half-batteries on the user's scalp so that small currents between the
deposition islands are
sustained after treatment.
For the present disclosure, when a 'metal-ion-deposition island' is formed
there is
a localized region of scalp wherein for at least one metal, the ion is
deposited within the
'deposition island'
FIG. 3 illustrates an exemplary disc including a plurality of distinct
protruding
electrodes 102 disposed uniformly around the disc 104. The 'uniform
distribution
feature' is not intended as a limitation.
FIG. 4 is a close-up illustration of 10 electrodes 102A-102D of a disc
illustrating
an inter-electrode distance Dist. FIG. 5 illustrates application of a
plurality of distinct
metal-ion-deposition ions on the surface of the scalp (i.e. the skin thereof)
by rolling,
without slipping, a disc over the surface of the scalp. In the non-limiting
example of
FIG. 5, a center of mass of the roller moves linearly and horizontally from
left-to-right
(i.e. defining a direction of disc velocity v) as a result of counterclockwise
rotation. A
downward force F is applied in a direction normal to the scalp, or a local
surface thereof.
As will be discussed below, in some embodiments, when the downward force is
localized along a contact-area of each the electrode, a pressure of at least
0.5 mega-
Pascals per electrode may be applied to the scalp.
In the example of FIG. 5, whenever an electrode is brought into contact with
the
skin, the electrode releases metal ions (i.e. either from an interior of the
electrode or
from a metal-coating that is integrally formed with the electrode). In the
example of
FIG. 5, electrodes 102A-102K respectively form metal deposition islands 202A-
202K.
As illustrated in FIG. 5, in a direction parallel to vector v (representing a
direction of linear
velocity of the roller), these metal deposition ions are separated on the
scalp by a distance that is
comparable to the inter-electrode distance illustrated in FIG. 2.
As noted above, in some embodiments, alternating discs are zinc-electrodes and
alternating discs are copper-electrodes. According to this non-limiting
example, all
electrodes 102 of discs 104A, 104C, and 104E deposit a cation (e.g. zinc) and
all
electrodes 102 of discs 104B, 104D and 104E deposit an anion.
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FIG. 6 schematically illustrates metal-ion-deposition islands on the scalp
after
rolling such a device over a user's scalp. In the schematic example of FIG. 6,
cation
metal-ion-deposition islands are represented as "+" (plus) while anion metal
deposition
islands are represented as "*" (star). In this example: (i) a distance between
adjacent
deposition islands of the same polarity (i.e. a distance between two
neighboring pluses,
or between two neighboring stars) is approximately equal to an inter-electrode
distance
for electrodes 102 disposed along a circumference of a disc; and (ii) a
distance between
deposition islands of opposite polarity (i.e.. a distance between a
neighboring star and
plus) is approximately equal to a lateral distance between laterally-adjacent
discs
FIG. 6 relates to the situation of a 'single pass' - i.e. the roller is moved
in a single
linear direction over the scalp. In some embodiments, the roller may be moved
'back and
forth' to perform a 'multi-pass' treatment. For example, the roller may be
manually
moved, the user may not move the roller in exactly a straight line introducing
some
degree of randomness in the distances between neighboring deposition-islands.
As illustrated in FIG. 5, in some embodiments, multiple electrodes of the same
disc are simultaneously in contact with the scalp -- in FIG. 5, electrodes
102H-102K are
simultaneously in contact with the skin. FIG. 7 illustrates a timeline showing
where
electrodes 102A-1021 are brought into contact and out of contact with the
scalp - for
example, electrode 102A is in contact with the scalp between times ti and t4,
electrode
102B is in contact with the scalp between times t2 and t5, and so-on.
When an electrode is in contact with the scalp, this is an 'electrode-scalp
contact
events' -- FIG. 7 illustrates the commencement and conclusion of electrode-
scalp contact
events for electrodes 102A-1021 in a heuristic example. Typically and as
discussed
below, each electrode-scalp contact event is quite brief- for example, at most
100 milli-
seconds. Nevertheless, the present inventors have found that even this very
brief contact
is sufficient to form a small metal-deposition island on the scalp, and that
it is useful to
form a large number of distinct metal-deposition islands, preferably, within a
relatively
short period of time.
It is possible to employ external electrical power to increase a current
between
electrodes of opposite polarity through the scalp while both electrodes are in
contact
with the skin, rather than relying exclusively on the galvanic current between
electrodes.
In some embodiments, this may allow for a therapeutically significant quantity
of metal
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ions in the metal-deposition-island formed by each contact event selected from
a
plurality of contact events, despite the relatively short electrode-scalp
contact period of
each contact event.
In some embodiments, some but not all contact events cause deposition of metal
ions on the skin or scalp. In these embodiments, it is still possible to
discuss a feature of
a specific set of contact events where all events are the specific set are
metal-ion-
depositing -- however, it is understood that additional contact events may be
performed
before and/or after and/or after a time-frame of the 'specific set of contact
events'.
In the example of FIG. 8, the electrodes 102 are 'non-wounding' since they do
not
enter the derails. The rounded tips of the electrodes allows the user to
provide significant
pressure (e.g. at 0.5 mega-Pascal) to achieve a less invasive but sufficiently-
stimulating
'micromassage' effect rather than a wounding or dermis-penetrating effect.
In the example of FIG. 8, negatively-charged ions are deposited on the skin to
create the metal-ion-deposition island.
FIG. 6 illustrates on pattern of metal-ion-deposition islands. FIG. 9
illustrates
another pattern. In the example of FIG. 9, a region of scalp comprises a
plurality of
different square 'patches' 206 (patches 206A-206J are illustrated) where a
patch is a
geometric construct to describe a portion of scalp. For example, a size of
each scalp
patch may be n mm X n mm where a n is a positive number having a value of at
most 5.
In the example of FIG. 9, cation and anion metal-deposition islands are both
respectively
applied to each patch of the ten patches.
Thus it may be said that at least one first-metal-deposition-island (i.e.
represented
by a '+') and at least one second-metal-deposition-island (i.e. represented by
a '*") are
both respectively and distinctly formed on each n mm x n mm scalp scalp-patch
206
selected from a 10-member scalp-patch sub-set of the scalp-patch set. - for
example, the
member scalp patch set {206A,206B,206C,206D,206E,206F,206G,206H,2061,206J}.
The term 'metal-ion-deposition' island refers to deposition of metal on the
user's
scalp such that at the moment of deposition, the metal is deposited as an ion.
There is no
requirement for the metal to remain in ionic form thereafter. A metal-ion-
deposition
island forms a localized portion of metal on the user's scalp.
Examples described above relate to deposition by a multi-disc roller.
Alternatively or instead of using disks, the electrodes may protrude from a
single solid
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roller (e.g. spherical or cylindrical). In one example, electrodes are
disposed at different
longitudinal positions along the roller. As discussed below, the method may be
performed using a non-roller device.
Also illustrated in FIG. I are axle 112, handle 114, housing 110, and power-
source 116.
Although some electrode-scalp contact events form metal-deposition-islands,
not
every contact event is required to deposit metal on the user's scalp.
Example Performance Parameters
One non-limiting use case relates to the following parameters: (i) a disc
radius of
16 mm and circumference of about 100 mm; (ii) about 100 protrusions per disc
so that a
distance between neighboring protrusions along a disk circumference is about 1
mm;
(iii) the user applies pressure (e.g. at least 0.5 mega-Pascal or at least 1
mega-Pascal per
electrode) has he/she rolls the disc array over his/her scalp, and thus rolls
the disc area
at a rate of about 0.3 revolutions/second corresponding to a linear velocity,
assuming.
Assume a 2-disk device, the number of distinct contact events per second (i.e.
where a protrusion is brought into and out-of contact with the scalp) in this
example is
about 0.3*100*2 65 contact-
events per second. In this situation, assuming the user
continuously rolls the disc over his/her scalp for at least one minute, the
scalp would be
subjected to about 4000 electrode-scalp contact events per minute.
Assuming an 8-disk device, the user's scalp would be subjected to about 16,000
contact events per minute.
= Cross sectional area of individual electrode-scalp contact-location
and/or metal-
deposition island: In an exemplary embodiment of the invention, the cross
sectional area of an electrode-scalp contact location is selected to be, for
example, about 1 mm2, about 0.1 mm2, about 0.01 mm2, about 0.001 mm2, about
0.0001 mm2, or other smaller, intermediate or larger sizes are used.
= Density: In an exemplary embodiment of the invention, the density of
contact
locations and/or deposition islands per unit area of scalp to be treated is
selected,
for example, about 1 locations/mm2, about 5 locatinos/mm2, about 8,
CA 02854387 2014-06-13
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locations/mm2 about 10 locations/mm2, or other smaller, intermediate or larger
densities are used.
= Total electrode-scalp contact area per electrode per contact event : In
an
exemplary embodiment of the invention, the area of scalp to be subjected to
ion-
deposition from the total area of the scalp to be treated is selected. The
'fill factor'
is selected to be, for example, about 10%, about 1%, about 0.1%, about 0.01%
of
the area to be treated, or other smaller, intermediate or larger values are
used. In
one non-limiting example, the fill factor is (i) at least 5% or at least about
7.5%
and/or (ii) at most 50% or at most 40% or at most 30% or at most 20% or at
most
15%.
= Gaps between deposition islands: In an exemplary embodiment of the
invention,
the distance between deposition-islands is selected. Optionally, the space
between deposition-islands along a first axis is selected. Optionally or
additionally, the space between deposition-islands along a second axis is
selected; for example, the first and second axes are perpendicular to one
another.
In some embodiments, gaps along at least one axis are selected according to
the
existing amount of hair at the area to be treated, for example, relatively
larger
spaces are selected for a region with relative denser hair and/or hair having
a
relatively larger diameter. Existing hair may be displaced to the gaps between
the
deposition-islands. Spaces between deposition islands along the first axis are
selected to be about, for example, 3mm, about 4.5 mm, about 6 mm, or other
smaller, intermediate or larger spaces are used. Spaces between electode
deposition islands along the second axis are selected to be, for example,
about
0.3 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, or other
smaller, intermediate or larger values are used
Figure 10A-10B are sides view of a electrode array 604 using electrodes 600 to
cause a pattern of deposition islands in the scalp 606.
Also illustrated in FIG. 10A are voids between disc -- this allows the discs
to
penetrate through the hair 624 -- i.e. when the discs penetrate through the
hair, the hair is
located in the voids between the discs.
In an exemplary embodiment, an actuator moves the electrode up and/or down.
CA 02854387 2014-06-13
In some embodiments, a group of electrodes is attached to a single actuator.
In an exemplary embodiment of the invention, a distance 626 and/or 628
between scalp 606 and device head 620 and/or 622 is set to provide a volume
for hair
624 during penetration of electrodes 600 through the hair to contact scalp
606. Hair 624
can be displaced into the volume to let electrodes 600 contact scalp 606 to
allow the full
length of electrodes 600 to enter. Distance 628 can be set for example, by
diameter of
discs 608 and/or by selecting the central hinge position within device head
620.
In an exemplary embodiment of the invention, the pattern of deposition-islands
is
parallel straight lines, for example, for a roll of discs 608. Optionally,
complex and/or
random patterns of deposition islands can be created by repeated rolling of
discs 608
over the scalp. Optionally, one or more discs each comprise multiple
electrodes,
arranged, for example, in a circumferential arrangement and/or along the
thickness of the
wheel, on the surface contacting the skin.
In an exemplary embodiment of the invention, electrodes 600 are made out of a
biocompatible material, non-limiting examples include; metals (e.g., steel,
silver, gold),
alloys, glass, plastic, ceramic.
In an exemplary embodiment of the invention, electrodes 600 are coated with a
type I 5a-reductase inhibitor, for example the metals zinc and/or copper.
It is noted that a series of discs disposed along a common rotation axis (see
FIG.
2, 10A) is just one example of a 'roller' having protrusions extending
therefrom (e.g. ion-
releasing and/or electrode-protrusions). For the case of the series of discs,
each disc has
substantially the same diameter so that the protrusions extended
radially/outwardly from
a common 'geometric-construct cylinder' that, for example, rotates at a common
rotation
rate (e.g. individual discs rotate in-tandem). This the series of discs is one
example of a
'cylindrical roller.'
Another example of a cylindrical roller is illustrated in FIG. 10B --
typically the
protrusions would be distributed around a circumference of the roller as was
the case for
the disks -- the fact that only a few protrusions as illustrated in FIG. 10C
is for brevity,
and is not meant to represent the typical case.
A cylindrical roller is one example of a 'round roller' - other examples may
be a
spherical roller shaped like an 'American football' illustrated in FIG. 10D.
CA 02854387 2014-06-13
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ELECTRODE/PROTRUSION ACTUATORS
Figures 11A-11F are illustrations of embodiments of electrode actuators, in
accordance with some embodiments of the invention. Optionally, electrode
actuators act
as vibrational elements, to vibrate electrodes according to the selected
vibrational
protocol.
In some embodiments of the inventions, one or more non-limiting examples of
actuators include; piezoelectric elements, motorized linear actuators, and/or
shape
memory alloy actuators.
In some embodiments of the invention, electrodes are individually vibrated.
Alternatively or additionally, groups of electrodes are vibrated together.
Optionally,
vibration is performed by an off-axis spinning mass, for example, the
direction of the
axis determines the plane of vibration. For example, translating the movement
to a linear
direction, pushing on a piston mass creates a linear vibration.
Figure I IA is an isometric view, and figure 11B is a cross sectional view of
a
electrode array 702, for example described with reference to figure 10B. Each
electrode
700 (of array 702 is coupled to an actuator 704. Optionally, each electrode
700 is
coupled to a separate actuator 704. Optionally, actuators 704 are attached to
a power
control 705.
For example, the actuators 704 may be controlled to maintain the electrode in
contact with the scalp for only brief electrode-scalp contact events.
Figure 11C is an isometric view, and figure 11D is a cross sectional view of a
electrode array 706. Two or more electrodes are controlled by actuators, for
example,
array of nine electrodes 708 is controlled by actuator 710 and, for example,
array of
electrodes 706 is controlled by actuator 711. There are two or more groups of
electrodes,
for example, four groups 708, 730, 732 and 734 of nine electrodes in each
group are
controlled by four actuators 710, 736, 738 and 740.
Electrode groups can be arranged in a variety of patterns. Non-limiting
examples
include the checkerboard pattern as illustrated in figure 11D, a bull's eye
pattern as
illustrated in figure 11E and/or a side by side tile pattern as illustrated in
figure 11F. For
example, the bull's eye pattern (Fig. 11E) may comprise one electrode 715 in
an inner
circle and at least two electrodes in electrode array 717 in an outer circle
and, for
CA 02854387 2014-06-13
17
example, the side by side tile pattern (Fig. 11F) may comprise eight groups
721, 722,
723, 724, 725, 726, 727 and 728 of electrodes.
In some embodiments, at least two groups (Fig. 11F) may touch the scalp
simultaneously. For example, the device is configured so that several
actuators receive a
signal to "lower" and touch and/or penetrate the scalp simultaneously.
Optionally or
alternatively, several electrodes are connected to a single actuator 710 and
go up and
down together. Optionally, the electrodes conform (or are advanced to conform)
to the
scalp curvature and penetrate together. In some embodiments, the electrodes
are
equipped with a spring to facilitate conformity to the scalp curvature.
In an exemplary embodiment, 721 and 722 may touch the scalp simultaneously,
722 and 723 may touch the scalp simultaneously, or 723 and 724 may touch the
scalp
simultaneously, or 724 and 725 may touch the scalp simultaneously, or 725 and
726 may
touch the scalp simultaneously, or 721, 722 and 728 may touch the scalp
simultaneously,
or 722, 725 and 727 may touch the scalp simultaneously or another combination
of
groups may touch the scalp simultaneously. Optionally, more than two types of
ions are
discharged from the electrodes. Figure 7G is an isometric view of a single
injector.
Figure 11H is an isometric view of a 1-dimensional array of electrodes. Figure
III
is an isometric view of a 2-dimensional array of electrodes.
Reference is now made to FIGS. 12A-12D. In some embodiments, the number
of ions deposited during treatment is controlled by adapting the voltage (see,
for
example, the methods described in Chizmadzhev et at, Electrical Properties of
Skin at
Moderate Voltages: Contribution of Appendageal Macropores), by adapting the
temperature (see, for example, the methods described in Maulsby et at, The
interrelationship between the galvanic skin response, basal resistance, and
temperature), and/or by adapting the frequency. Increasing the voltage,
temperature and
frequency can each increase the number of ions deposited. For example, the
number of
ions deposited during treatment is controlled in an open loop manner by
determining the
voltage before beginning treatment. Alternatively, the number of ions
deposited during
treatment is controlled in a closed loop manner by determining the voltage
during the
treatment based on feedback received from sensors incorporated into the
device.
In some embodiments, controlling the ions deposited is done directly by
measuring
the charge of each polarity (ion type) or of both, for example, by measuring
and
CA 02854387 2014-06-13
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integrating the (absolute) current passed through each type of disk set or
through both.
The existence of current indicates the unit is in actual use. A degradation of
current
indicates a faulty unit, improper contact, or other means. Excessive current
might
indicate a faulty unit, or excessive moisture on the scalp (and therefore not
enough
current through the scalp).
In some embodiments, the mass of metal ions discharged from the electrodes
may be calculated by a formula. For example, assuming the charge C is ionic,
and the
oxidation state Z, the mass m of metal ions discharged from the electrodes (w
is the
atomic mass, e the electron's charge, Na is Avogadro's number) is computed as
follows:
C = w
m ¨ _________________________________________
e = Z = Na
In some embodiments, ion injecting electrodes that touch the scalp are
connected
to one terminal of a power source and an electrode that does not touch the
scalp is
connected to a second terminal of the power source. For example, the electrode
that does
not touch the scalp may be connected to a part of the body other than the
scalp. For
example, the device may comprise a handle comprising an electrode designed to
touch
the palm of a person holding the handle.
In some embodiments, the efficiency of the deposition of ions is enhanced, for
all
users or for a specific user, by performing a "calibration phase" in which the
same
region is treated for a period of a time while changing each parameter
slightly and
measuring the real-time response in current. Optionally, different treatment
parameters
may be chosen for different scalp areas of same user. Optionally, different
treatment
parameters may be chosen for different users.
In some embodiments, the efficiency of the deposition of ions is enhanced
through
general improvements in the parameters, for example, preparing a better cross
section of
the electrodes and/or starting with more efficient voltage and frequency.
Optionally, the
efficiency of the deposition of ions is enhanced through dynamic modification
of
changeable treatment parameters through closed-loop feedback/control.
In some embodiments, ion penetration increases blood flow when the electrical
fields
generated by the small charge deposits create a MENS (microcurrent electrical
neuromuscular stimulation) effect in the skin. Optionally, the MENS effect
shortens skin
healing times. Optionally, the electrical fields invigorate movement of
essential ions and
stimulate the skin systems into an increased rate of activity.
CA 02854387 2014-06-13
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Figure 12A is an illustration of an array of electrodes 802 depositing
materials 804
beneath the skin 806 surface of scalp, in accordance with an exemplary
embodiment of
the invention. For simplicity purposes, array 802 comprises four electrodes
808, having
the material 804 to deposit located at the part of the electrode 808 that
contacts scalp
806.
In an exemplary embodiment of the invention, electrodes 808 are made of
material
804. Alternatively, electrodes 808 are coated with material 804. Optionally or
alternatively, 830, 832, 834 and/or 836 represent electrical potentials which
may exist on
electrodes 808.
In an exemplary embodiment of the invention, two different electrodes 808 to
be
electrically coupled have two different materials 804 at their ends. For
example,
alternating discs (e.g., as illustrated in figure 1) are made from different
materials, for
example, copper and zinc.
In some embodiments, scalp 806 acts as a bridge, placing two electrodes having
dissimilar metals in electrical contact. The metals can undergo galvanic
corrosion, where
one metal dissolves in scalp 806, while the other metal absorbs ions from
scalp 806. For
example, if one metal is zinc and the other metal is copper, the zinc will
dissolve and the
copper will accumulate. Optionally, material 804 is chosen to have other
depositing
effects. Optionally or additionally, current is forced in the opposite
direction.
Figure 12B is an illustration of ion deposition into scalp 806 for example
using a
galvanic cell set-up, in accordance with an exemplary embodiment of the
invention.
Optionally, a power source 812 electrically couples a first electrode 814 and
a second
electrode 816. For example, each electrode 814 and 816 may be coated
electrodes
comprising different materials at the ends 815 and 817, for example, electrode
814
touches scalp 806 at end 815 with zinc and electrode 816 at end 817 with
copper.
Optionally, power source 812 emits Alternating Current (AC). Optionally, power
source
812 emits Direct Current (DC).
Figure 12C is an illustration of using the set-up as in figure 12B to release
zinc ions
into scalp 806, in accordance with an exemplary embodiment of the invention.
The
positive pole of power source 812 is electrically connected to electrode 814
with zinc
(e.g., acting as the anode 840), and the negative pole is electrically
connected to
electrode 816 with copper (e.g., acting as the cathode 842). Zinc ions 819 are
discharged
CA 02854387 2014-06-13
from electrode 814 into scalp 806, and copper ions 821 and/or other ions 823
are
accumulated from scalp 806 onto electrode 816.
In an exemplary embodiment of the invention, the voltage of power source 812
as in figure 12C is, for example, about 1V, about 3V, about 5V, about 7V,
about 10V,
about 30V, or other smaller, intermediate or larger values are used.
Figure 12D is an illustration of using the set-up of figure 12B to release
copper
ions into scalp 806, in accordance with an exemplary embodiment of the
invention. The
positive pole of power source 812 is electrically connected to electrode 816
with copper
(e.g., acting as the anode 850), and the negative pole is electrically
connected to
electrode 814 with zinc (e.g., acting as the cathode 852). Copper ions 821 are
discharged
from electrode 816 into scalp 806, and zinc ions 819 and/or other ions 823 are
accumulated from scalp 806 onto electrode 814.
In an exemplary embodiment of the invention, the voltage of power source 812
as in figure 21D is at least greater than the standard potential for the
reaction, for
example, above 1.10 Volt.
In an exemplary embodiment of the invention, power source 812 is an
alternating
current source. The frequency of source 812 can be selected to result in a
desired ion
deposition pattern, for example alternating between the set-ups as described
in figures
12C and 12D. For example, the frequency of source 812 is selected to be
substantially
half of the rate of electrode-scalp contact events per second, for example
when using the
hair stimulation device with rolling discs, for example, as described with
reference to
figure 1. For example, if the device is rolled over the scalp to achieve a
rate of scalp-
electrode contact events of 30 events per second and the frequency of source
812 is 15
Hz, the ions deposited during each electrode-contact will alternate, for
example between
copper and zinc. Furthermore, different ions will be deposited at different
locations.
In some embodiments of the invention, the AC waveform (e.g., duty cycle) is
selected according to the ratio of the desired material deposition. For
example, to
achieve a 10:1 ratio (e.g., of zinc:copper), a waveform having a 10:1 ratio
(91% duty
cycle) is selected. Alternatively or additionally, the number of electrodes
coated with
each material is selected according to the desired deposition ratio, for
example, the
number of electrodes coated with zinc relative to the number of electrodes
coated with
copper is 10:1.
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In some embodiments of the invention, power source 812 is a direct current
source.
The polarity of source 812 can be selected to result in a desired ion type
and/or
deposition pattern; for example, according to the set-ups of figures 12C
and/or 12D. The
set-up of figure 12C can also be achieved without source 812, for example by
electrically connecting electrodes 814 and 816.
In some embodiments of the invention, materials (e.g., ions) are added
directly to the
scalp, for example in the form of a lotion, gel and/or water. Non-limiting
examples of
ions in this form include ZnSO4, CuSO4. The lotion can be added in addition to
the use
of coated electrodes, or instead of coated electrodes (e.g., using uncoated
electrodes).
Optionally, the ions penetrate below the surface of the skin.
ELECTRICAL STIMULATION
In an exemplary embodiment of the invention, the scalp is stimulated by
applying one or more currents and/or voltages to areas of the skin, for
example, an
electrical stimulation protocol is selected. Optionally, a plurality of
currents and/or
voltages are applied to the scalp, for example different voltages and/or
currents to
different areas and/or between different electrodes.
In an exemplary embodiment of the invention, the electrical stimulation is
separate from the current applied to the electrodes to release ions, for
example,
optionally, electrical stimulation is applied by one or more discs and/or
electrodes, and
ion deposition is applied by different discs and/or electrodes. Optionally,
the electrodes
to apply electrical stimulation but not ion deposition are inert, for example,
made from
platinum. Alternatively, a voltage is applied to the electrodes to prevent ion
deposition
by the galvanic effect. Alternatively or additionally, electrical stimulation
and ion
deposition overlap, for example, applied by the same discs and/or electrodes.
Inventors hypothesize that selectively applying a plurality of electrical
stimulation patterns (e.g., voltages and/or currents) to the scalp will
promote hair
growth. However, the efficacy of some embodiments of the invention can be
unrelated
to the underlying theory, and work even if the theory is incorrect.
In an exemplary embodiment of the invention, the electrical stimulation
protocol
comprises one or more variables. Non-limiting examples of selectable
parameters
include:
CA 02854387 2014-06-13
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= Geometric voltage and/or current distribution pattern: The pattern of
applied
voltages and/or current per electrode. For example, the voltage and/or current
at
each electrode is independently controlled and/or groups of electrodes have
similar voltages and/or current (e.g., alternating electrodes have similar
voltages
and/or currents, electrodes having the same type of material (for example zinc
or
copper) have similar voltages and/or currents).
In sonic embodiments of the invention, the voltage and/or current pattern is
substantially the same, for example, the same electrode is associated with the
same charge and/or current. Alternatively or additionally, the voltage and/or
current pattern is dynamic, for example dynamic throughout the array, and/or a
region of the array. For example, in a relatively large array, a relatively
small
patch of the electrical pattern can be scanned across the array.
A potential advantage of two groups of electrodes with different voltages is
the controlled patterning of current and/or ion deposition. For example, local
stimulation may be superior to global. Potentially, division to several groups
allows greater flexibility and/or controllability of the current. For example,
current can be applied (e.g., to different groups, at different intensities)
simultaneously or in a time-divided manner.
= Voltage and/or current distribution pattern over time: The pattern of
applied
voltage and/or current per electrode can vary over time. For example, an
alternating current and/or voltage can be applied to vary the voltage and/or
current between two or more electrodes (or groups of electrodes). In the case
of
using the device with discs for example in figure 1 (e.g., rolling the discs
with
electrodes on the scalp), selecting an alternating frequency that is less than
the
frequency of rotation can result in increasing the diversity and/or gradients
of
voltages and/or currents applied underneath the skin surface. Inventors
hypothesize that applying various patterns of voltage and currents to the skin
stimulates hair growth. Potentially, applying varying time and/or location
stimulations improves stimulation of local points, for example hair follicles
= Direct current (DC) offset: A voltage offset can be applied to the
pattern applied
to one or more electrodes. In an exemplary embodiment of the invention, the DC
offset is calibrated, for example, from -3 volts to +3 volts, or other
smaller,
CA 02854387 2014-06-13
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intermediate or larger values are used. In an exemplary embodiment of the
invention, the DC disc to disc relative voltage ranges, for example, from 0 to
30
volt, or other smaller, intermediate or larger values are used.
= Alternating current (AC) peak to peak voltage: In an exemplary embodiment
of
the invention, the peak to peak voltage of the AC varies, for example, from -
10
volts to +10 volts, or other smaller, intermediate or larger values are used.
= Frequency of AC: In an exemplary embodiment of the invention, the
frequency
of AC ranges, for example, from 10-1000 Hz, or other smaller intermediate or
larger values are used.
= Waveform of AC: In an exemplary of the invention, the waveform of AC is
rectangular. Alternatively, other waveforms are used, non-limiting examples
include sinusoidal, triangular, sawtooth.
= Maximal Current: In an exemplary embodiment of the invention, the total
electrical current is less, for example, than 0.5, less than 1, less than 2
milliAmperes, or other smaller, intermediate or larger values are used.
A Discussion of FIG. 13A-13D -- Protrusions Designs to Penetrate Only a Short
Depth
of the Skin
In some embodiments, the protrusions 102 are designed to regulate a depth of
skin-penetration during use - e.g. so the skin is penetrated to a depth of
least 5 microns
or at least 10 microns and/or at most 100 microns or at most 75 microns or at
most 50
microns or at most 20 microns. This may be the penetration during 'ordinary
use' and/or
when a tip of the electrode-protrusion is pressed against a healthy human
scalp at a
pressure of between 0.1 to 5 MPa (e.g. a pressure of about 0.1 MPa or a
pressure of
about 0.5 MPa or a pressure of about 2 MPa or a pressure of about 3 MPa or a
pressure
of about 4 MPa or a pressure of about 4 MPa or a pressure of about 5 MPa)
For example, this may be at a localized electrode-scalp contact area of at
most 10
mm2.
Examples of protrusions having this capability are illustrated in FIG. 13A-
13D.
A 'greater thickness' refers to cross-section of the protrusion - there is a
thickness
in two orthogonal directions (i.e. orthogonal to each other and perpendicular
to the
longitudinal direction) -- the 'greater thickness' is the greater of these
dimensions.
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In some embodiments, each of the protrusions compriss: (i) an electrode-
protrusion main body 994, characterized by a greater-thickness of at most 2 mm
(e.g. at
least 0.5 mm or at least 1 mm) and/or a length at least 0.2 mm or at least 0.5
mm or at
least 1 mm, the main-body being blunt at its distal end and/or the main-body
having a
blunt distal-facing surface; and one or more sharp mini-needle(s) 992
extending from the
blunt distal end or the blunt distal-facing surface of the main body, the mini-
needle 992
being sharp at a distal surface thereof. In some embodiments, a length the
sharp mini-
needles is at least 10 microns or at least 20 microns and/or at most thereof
being between
and 150 microns.
A Discussion of FIGS. 14-15
In some embodiments, instead of a roller a scalp-brush is provided. In the
example of FIG. 14A, the base-surface is rigid, but as shown below (FIG. 15D)
in some
embodiments, the base-surface may be conformable - e.g. having a first
configuration
(top of 15D,. where the protrusions are parallel to each other) and a second
configuration
where due to conforming and/or base deformation that protrusions converge
towards
each other (bottom of FIG. 15D). The feature of FIG. 15D may allow the distal
ends of
the brush to conform to a shape of the scalp and the deformation of the base-
surface may
be in respond to higher pressure towards the center of the 'field of
protrusions.'
As shown in FIG. 14B, in some embodiments, it is possible to drag or 'rake'
the
brush across the user's scalp to obtain 'streaks' instead of the ion-
deposition ions
discussed above.
As shown in FIG. 15A-15C, it may be possible to provide a functionality
similar
to that of FIG. 15D (i.e. where the surface defined by the distal end of the
protrusions
'conforms' to the scalp) by protrusion flexibility.
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Ion-Deposition Heterogeneity (e.g. of deposition islands)
FIG. 9 illustrates one island-deposition pattern where there is some degree of
'deposition heterogeneity' (e.g. in two dimensions as opposed to FIG. 6 which
illustrates
such heterogeneity only in a single dimension).
Towards this end, it may be useful for any embodiments (e.g. brush or roller)
to
distribute protrusions capable of depositing different types of ions over the
'base' surface
of the roller or brush.
FIG. 16A illustrates a 'common plane' through which the protrusions pass. Just
like it is possible to define the 'heterogeneity' in terms of island
deposition on skin-
patches, it is also possible to define 'heterogeneity' in terms of the
capability of the ion
deposition passing through a 'patch' of the 'common plane.' FIG. 16B
illustrates a 'patch'
for the device of FIG. 16B -- for roller devices, the 'square patch' is a
square in
'curvilinear coordinates' relative to a 'round common-surface' over the roller
-- this
round common-surface' has the same shape the roller surface (i.e. the round
common-
surface is a geometric construct and its shape is identical to that of the
roller surface -- if
the roller surface is cylindrical than the round common-surface is cylindrical
and if the
roller surface is spherical than the round common-surface is spherical).
Examples of
'square patches' on the 'curvilinear' surface are illustrated in FIGS. 16C-
16D.
Light-Guide
As shown in FIG. 17, in some embodiments, the electrode may be a 'hybrid
electrode protrusion' for delivering both current (eg. at least partially
ionic) as well as
light (e.g. through a light-guide optical properties of the protrusion).
Feedback -- a discussion of FIG. 18
FIG. 18A is a flow chart of a method for operating a device according to
feedback. FIG. 18B is a block diagram of a system for performing the method of
FIG.
18.
It may be possible (step S105) to measure an indication of how effective the
treatment is -- for example, to measure a rate at which ions are deposited on
the scalp
(greater deposition is more effective treatment) and/or an amount of current
between
electrodes (greater is more effective treatment) or a degree of color-change
of the scalp
CA 02854387 2014-06-13
26
(e.g. optically by a camera or in any other manner - greater change means
irritation -
more effective treatment).
If this indicator shows (step S109) that the treatment is not effective enough
it is
possible to generate an alert (e.g. an 'immediate alert') to encourage the
user, for
example, to press harder on his/her scalp with the device.
Alternatively or additionally, the device may provide the user an indication
of an
end of a given treatment session - e.g. by a treatment-end alert signal (e.g.
audio or
visual or tactile) or by shutting off the vibration, current or light. In this
case, if the
indications shows the treatment is not effective enough it is possible to
compensate by
increasing a treatment duration - e.g. the amount of time which must elapse
before the
treatment-end indication (e.g. alert signal or shutting off) is provide to the
user.
Alternatively or additionally, it is possible to compensate by increasing a
voltage
applied between electrodes (e.g. ion-releasing electrodes). For example, it
may be
possible to respond with several voltage or current pulses (e.g. brief in
duration - e.g. <1
sec or <0.5 sec or <0.1 sec or <0.05 sec)
For the first case (the 'alert signal'), alert signal may be provided if the
user is not
pressing hard enough (even if painful) - this would encourage the user to
press harder.
For roller embodiments, the resistance to rolling may be increased if the user
is not
pressing hard enough.
In one embodiment, a 'minimum treatment effectiveness' is characterized by
minimum current or ion-deposition rate or force or roll-rate (or any
combination
thereof).
In yet another embodiment, it is possible to optically and/or mechanically
detect
a presence of tangled or trapped hair (e.g. trapped in the roller or in any
other device
form-factor) and to respond with an alert signal.
In yet another embodiment, it is possible to regulate the 'effective
sharpness'
and/or 'effective penetrating ability' of the protrusion - e.g. by regulating
the length of
the mini-needle of FIG. 13 -- e.g. if the treatment effectiveness indicator is
below a
threshold, it may be possible to cause the protrusion to be 'effectively
sharper' to
compensate for too-little ion-deposition by greater penetration.
CA 02854387 2014-06-13
27
Alternatively or additionally, a scalp thickness sensor (e.g. based on
ultrasound)
may be provided -- for thicker scalps it is possible to increase the intensity
of treatment
(e.g. effective sharpness and/or ion-deposition rate and/or voltage between
electrodes).
FIG. 19
Fig. 19 describes one embodiment of a brush form with a vibrating plate. In
this
embodiment, the brush comprises an optionally conforming base (191) and an
optionally
perforated vibration plate (193) the bristles (192) go through. The
conformation of the
base allows the bristles to move up and down through the perforate vibrating
plate so a
maximal number of bristles are in contact with the scalp simultaneously.
The vibration plate is located 5mm, lOmm, 15mm, or 20 mm below the base and
above
the end of bristles. It is connected to a vibrator (194) that can vibrate it
laterally.
Optionally, the vibration is in each axis, optionally independently controlled
per axis.
This embodiment provides effective lateral vibration to the bristle ends,
while adding
configurable rigidity to the teeth. The distance between the base and
vibrating plate
determines the rigidity of the teeth.
Various embodiments and aspects of the present invention as delineated
hereinabove
and/or as claimed in the claims section below find experimental support in the
following
examples:
EXAMPLE - EXPERIMENT
Reference is now made to the following example, which together with the above
descriptions illustrates some embodiments of the invention in a non-limiting
fashion. In
particular, features described below may be used without other described
features and in
conjunction with methods and/or apparatus as described above.
Material and methods -- An experiment over 2-4 months was conducted on 26
volunteers all of whom were suffering from baldness. Each volunteer was
provided with
a roller-like device (see, for example, FIG 1) configured to form both zinc-
ion-
deposition islands and copper-ion-deposition islands when rolled over the
scalp. As the
user rolled the device over his respective scalp, electrodes of the roller
device were each
CA 02854387 2014-06-13
28
briefly brought into contact with and out of contact with the scalp. The
device used
included 8 disks with non-puncturing electrode protrusions, used for several
minutes at
least twice a week by users.
Each disk had about 100 protrusions, about 0.2min wide and a triangular
protrusion with effective contact length of lmm (tip is about 0.1mm)
Disks were alternatively coated with Zinc and Copper.
Electrical current applied was about 30V at 40Hz.
No LLLT was applied.
For each subject, it was possible, per treatment site, to monitor a number of
features related to hair density at the treatment site, such as the overall
hair density,
terminal hair-density and non-terminal hair density. Results are summarized in
FIGS.
213A-213B. The skilled artisan who reviews FIGS. 213A-213B will appreciate
that the
device and method appeared to play a significant roll in reversing hair-loss.
Although the invention has been described in conjunction with specific
embodiments thereof, it is evident that many alternatives, modifications and
variations
will be apparent to those skilled in the art. Accordingly, it is intended to
embrace all
such alternatives, modifications and variations that fall within the spirit
and broad scope
of the appended claims.
All publications, patents and patent applications mentioned in this
specification
are herein incorporated in their entirety by reference into the specification,
to the same
extent as if each individual publication, patent or patent application was
specifically and
individually indicated to be incorporated herein by reference. In addition,
citation or
identification of any reference in this application shall not be construed as
an admission
that such reference is available as prior art to the present invention. To the
extent that
section headings are used, they should not be construed as necessarily
limiting.
It is expected that during the life of a patent maturing from this application
many
relevant hair stimulation devices will be developed and the scope of the term
hair
stimulation device is intended to include all such new technologies a priori.
As used herein the term "about" refers to 10 %.
The terms "comprises", "comprising", "includes", "including", "having" and
their conjugates mean "including but not limited to".
The term "consisting of' means "including and limited to".
CA 02854387 2014-06-13
29
The term "consisting essentially of' means that the composition, method or
structure may include additional ingredients, steps and/or parts, but only if
the
additional ingredients, steps and/or parts do not materially alter the basic
and novel
characteristics of the claimed composition, method or structure.
As used herein, the singular form "a", "an" and "the" include plural
references
unless the context clearly dictates otherwise. For example, the term "a
compound" or
"at least one compound" may include a plurality of compounds, including
mixtures
thereof.
Throughout this application, various embodiments of this invention may be
presented in a range format. It should be understood that the description in
range format
is merely for convenience and brevity and should not be construed as an
inflexible
limitation on the scope of the invention. Accordingly, the description of a
range should
be considered to have specifically disclosed all the possible subranges as
well as
individual numerical values within that range. For example, description of a
range such
as from I to 6 should be considered to have specifically disclosed subranges
such as
from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6
etc., as well
as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6.
This applies
regardless of the breadth of the range.
Whenever a numerical range is indicated herein, it is meant to include any
cited
numeral (fractional or integral) within the indicated range. The phrases
"ranging/ranges
between" a first indicate number and a second indicate number and
"ranging/ranges
from" a first indicate number "to" a second indicate number are used herein
interchangeably and are meant to include the first and second indicated
numbers and all
the fractional and integral numerals therebetween.
As used herein the term "method" refers to manners, means, techniques and
procedures for accomplishing a given task including, but not limited to, those
manners,
means, techniques and procedures either known to, or readily developed from
known
manners, means, techniques and procedures by practitioners of the chemical,
pharmacological, biological, biochemical and medical arts.
As used herein, the term "treating" includes abrogating, substantially
inhibiting,
slowing or reversing the progression of a condition, substantially
ameliorating clinical
CA 02854387 2014-06-13
or aesthetical symptoms of a condition or substantially preventing the
appearance of
clinical or aesthetical symptoms of a condition.
Appendix
FIG. 102 is a general block diagram of the device, in accordance with an
exemplary embodiment of the invention;
FIG. 104 is a flow chart of a method of stimulating hair growth, in accordance
with an exemplary embodiment of the invention;
Figure 104 is a flowchart of an exemplary method of stimulating scalp hair
growth, in accordance with an exemplary embodiment of the invention.
Optionally, the
method uses the hair stimulation device.
Optionally, at 402, a patient is selected, in accordance with an exemplary
embodiment of the invention. Optionally, the patient is male. Optionally or
additionally,
the patient has been diagnosed with androgenic alopecia. Optionally, the
patient is at
the early stages of hair loss (e.g., has not lost most of his hair).
Optionally, at 404, the treatment plan is selected, in accordance with an
exemplary embodiment of the invention. Optionally, a mechanical stimulation
protocol
is selected. Optionally or additionally, a vibration stimulation protocol is
selected.
Optionally or additionally, a thermal stimulation protocol is selected.
Optionally or
additionally, an ion deposition protocol is selected. Optionally or
additionally, an
electrical stimulation protocol is selected.
In some embodiments of the invention, at least some of the stimulation
protocols (e.g., vibration, thermal, ion, electrical) are applied
substantially
simultaneously. Alternatively or additionally, at least some of the protocols
are applied
successively, for example, in no particular order. Alternatively or
additionally, some
protocols are selectively applied, while other protocols are not applied.
In some embodiments of the invention, the treatment plan is selected manually,
for example by a physician, for example, based on personal experienced and/or
clinical
guidelines. Alternatively or additionally, the treatment plan is selected
automatically,
for example by software, for example, based on collected experimental data.
In some embodiments of the invention, the treatment plan is selected over a
long
period of time, for example, a single treatment session is to be repeated for
a duration of
CA 02854387 2014-06-13
31
time. For example, a single treatment plan is repeated four times a day, three
times a
day, twice a day, once a day, every other day, three days a week, twice a
week, once a
week, or other smaller, intermediate or larger time frames and/or repetition
rates are
used. For example, treatment is repeated over a month, over two months, over
six
months, over one year, over two years, indefinitely, or other smaller or
intermediate
time frames are used. Optionally, treatment is stopped when a desired growth
effect is
achieved and/or a certain time after, for example, a week or a month.
Optionally or
alternatively, stimulation is stopped, or at least paused for a week or more,
if further
progress is not seen. Optionally, the application and/or delay of treatment
depends on
scalp thickness, with treatment, for example, being continued as long as scalp
thickness
continues to increase and/or only if an increase is found.
In an exemplary embodiment of the invention, a maintenance level of treatment
is defined and followed by the user.
In some embodiments of the invention, the treatment plan is selected so that a
different
part of the scalp is treated during different treatments. For example,
treatment may be
twice a day with a different part of the scalp treated during each of the two
daily
treatments. Optionally, the areas of treatment during different treatment
sessions
partially overlap.
In some embodiments of the invention, the time per session is selected. For
example, about 30 seconds, 1 minute, 2, 4, 6, 10 minutes, or other smaller,
intermediate
or larger times or subranges thereof are used. Optionally, the time is
selected according
to a pain level caused by the device and/or a user pain and/or comfort
threshold.
In some embodiments of the invention, the treatment area is selected. For
example, approximately 50% of the total area in need of treatment, 10%, 25%,
33%,
67%, 75%, 90%, 100% or other smaller, intermediate or larger areas or
subranges
thereof are used.
At 406, the treatment plan and/or protocol is applied to the patient, in
accordance with an exemplary embodiment of the invention. For example, the
patient
holds the device, and rolls the discs over the area of his scalp that requires
stimulation.
The needles on the discs prick his scalp according to the mechanical
stimulation
protocol. Optionally or additionally, the needles are vibrated according to
the vibration
protocol. Optionally or additionally, the skin is heated underneath the
surface (e.g., heat
CA 02854387 2014-06-13
32
transferred through the needles) according to the thermal stimulation
protocol.
Optionally or additionally, ions are deposited into below the skin (e.g.,
released from
metallic coating on the needles) according to the ion deposition protocol.
Optionally or
additionally, electrical current and/or voltages are applied underneath the
surface of the
skin (e.g., using the needles as electrodes) according to the electrical
stimulation
protocol.
In a non-limiting example, a protocol comprises of treatments applied 3 times
a
week, for about 5 minutes per treatment. Each treatment comprises the
following
stimulations: 5 Volts, at 100 Hz AC, Zinc biased duty cycle, heating to a
temperature of
60 degrees Celsius and vibration. Optionally, the protocol is selected
according to trial
and error, for example, the protocol is adjusted after a couple of weeks
depending on
the response of the scalp.
Optionally, at 408, the treatment is repeated, for example, according to the
plan
as in 404, in accordance with an exemplary embodiment of the invention.
Optionally,
the same treatment protocol is repeated. Alternatively, the treatment protocol
is
adjusted. For example, the initial treatment protocol is selected, the
treatment is applied,
and the treatment is adjusted based on feedback of success of the treatment.
FIG. 105 is a flowchart of a detailed method of figure 104, in accordance with
an exemplary embodiment of the invention;
EXEMPLARY METHOD OF TREATMENT
Figure 105 is a detailed method of treatment of figure 104, in accordance with
an exemplary embodiment of the invention.
Optionally, at 502, a patient is selected for treatment,.
Optionally, at 504, a decision is made with regards to the mechanical
stimulation protocol.
Optionally, at 506 a decision is made with regards to the vibration protocol.
Optionally, at 508 a decision is made with regards to the thermal stimulation
protocol.
Optionally, at 510 a decision is made with regards to the ion application
protocol.
CA 02854387 2014-06-13
33
Optionally, at 512 a decision is made with regards to the electrical
stimulation
protocol.
Optionally, at 522 a decision is made with regards to the use of adjuvant
treatment.
Optionally, at 524 a decision is made with regards to the use of light
stimulation.
Optionally, at 526 a decision is made with regards to the spatial and temporal
parameters.
Optionally, at least one of the parameters chosen in steps 504, 506, 508, 510,
512, 522 and 524 are specific per scalp area and are determined individually
for each
scalp area to be treated. For example, the temple area could receive one
treatment and
the vertex area could receive a different treatment. For example, it may be
determined
to treat the vertex area consecutively 5 minutes daily while the temples area
is to be
treated consecutively 4 minutes daily.
At 514, the treatment plan is applied.
Optionally, at 516 feedback related to the treatment is obtained.
Optionally, at 518 one or more variables of one or more treatment protocols
are
adjusted. Optionally, the adjustment is related to the feedback as in 516.
Optionally, at 520 treatment is repeated.
Per Fig. 6A, in an exemplary embodiment of the invention, needles, for example
needles 600, are selected and/or arranged as an array according to the
selected
mechanical stimulation protocol. Non-limiting examples include; a cross
sectional
diameter 610 corresponding to the selected area of individual contacts and/or
penetrations, a length 612 corresponding to the selected depth of pnetration
(optionally,
a stopper 632, for example a flat disc, is used to set the needle length to
prevent the
needle from deeper penetration into the skin).
Figures 114A and 114B illustrate discs comprising a light source. In an
exemplary embodiment, light conducting disc 1400 (Fig 114A) comprises light
source
1402 causing light 1404 to emanate from spike 1410 on disc 1400. Optionally,
disc
1400 comprises translucent material. Optionally or alternatively, spike 1410
comes to a
sharp point. Optionally, spike 1410 is metallic.
CA 02854387 2014-06-13
34
Figure 14B illustrates an exemplary embodiment in which light 1404 originates
from light source 1402 and travels through optical fibers 1406 embedded in
disc 1400.
Optionally, the optical fibers 1406 penetrate directly into the skin.
Optionally, optical
fibers 1406 are thin enough to easily penetrate skin.
In some embodiments, one or more discs each comprise multiple fibers and/or
needles. Optionally, at least one disc is for optical stimulation. Optionally
or
alternatively, at least one disc is metallic. Optionally or alternatively, at
least one disc
includes both optical needles and metallic needles. Optionally, at least one
needle is
both optical and metallic. Optionally or alternatively, fiber and/or needle
are provided
on parallel discs. Optionally or alternatively, fibers and/or needles are
provided in a
planar array.
Figure 115 illustrates an injector comprising a light guide, in accordance
with an
exemplary embodiment of the invention. In an exemplary embodiment, the light
guide
is an optical fiber coated with metal. For example, light is produced by light
source
1502 which is powered by power source 1500 and emanates light 1504.
Optionally,
power source 1500 is electrical.
In some embodiments, power source 1500 emits ions 1508 directly into the
scalp beneath the scalp surface 1506. Optionally, power source 1500 emits
electricity
directly into the scalp beneath the scalp surface 1506. Optionally, power
source 1500
emits heat directly into the scalp beneath the scalp surface 1506. Optionally,
the discs,
needles and/or optical fibers also vibrate.
In some embodiments, the injector comprises a cavity 1512. Optionally, cavity
1512 comprises a light conducting core. For example, cavity 1512 may comprise
light
transmitting material. Optionally, the light transmitting material has
structural rigidity.
Optionally or alternatively, the light transmitting material has minimal
structural
rigidity.
In some embodiments, cavity 1512 comprises an internal optical fiber. For
example, the internal optical fiber may comprise a metal coated thin optical
fiber.
Optionally or alternatively, the internal optical fiber may comprise an
external shell
conducting electricity. Optionally or alternatively, the internal optical
fiber may
comprise an external shell conducting heat. Optionally or alternatively, the
internal
CA 02854387 2014-06-13
optical fiber may comprise an external shell conducting injecting ions into
the skin.
Optionally or alternatively, the internal optical fiber may emit light into
the skin.
In some embodiments, hollow cavity 1512 comprises a void which transmits
light. Optionally, the outer portion 1510, inside outer layer 1512, of the
injector
comprises a source of vibration. Optionally or alternatively, the outer
portion of the
injector comprises a source of heat.
In some embodiments, the outer layer 1514 comprises an electrical conductor.
For example, outer layer 1514 comprises metal. Optionally, outer layer 1514 is
coated
with ions to be deposited. For example, outer layer 1514 is coated with Cu.
Alternatively, outer layer 1514 is coated with Zn. Optionally, outer layer
1514
comprises heat conducting material.
GENERAL
It is appreciated that certain features of the invention, which are, for
clarity,
described in the context of separate embodiments, may also be provided in
combination
in a single embodiment. Conversely, various features of the invention, which
are, for
brevity, described in the context of a single embodiment, may also be provided
separately or in any suitable subcombination or as suitable in any other
described
embodiment of the invention. Certain features described in the context of
various
embodiments are not to be considered essential features of those embodiments,
unless
the embodiment is inoperative without those elements.
