U.S. patent application number 11/910330 was filed with the patent office on 2009-12-24 for probe device, system and method for photobiomodulation of tissue lining a body cavity.
This patent application is currently assigned to Esther Mayer. Invention is credited to Esther Mayer.
Application Number | 20090319008 11/910330 |
Document ID | / |
Family ID | 37053790 |
Filed Date | 2009-12-24 |
United States Patent
Application |
20090319008 |
Kind Code |
A1 |
Mayer; Esther |
December 24, 2009 |
PROBE DEVICE, SYSTEM AND METHOD FOR PHOTOBIOMODULATION OF TISSUE
LINING A BODY CAVITY
Abstract
A device (10) is presented for use in treatment of tissues
inside a body cavity. The device comprises a probe member (12)
having at least a portion thereof carrying a plurality of light
sources (18), at least said portion of the probe member (10) having
dimensions and shape suitable for insertion into a certain body
cavity and for arranging within the surface thereof a
three-dimensional array of said light sources, the light sources
being configured and operable to irradiate optical energy outwardly
from said probe member.
Inventors: |
Mayer; Esther; (Ra'anana,
IL) |
Correspondence
Address: |
BROWDY AND NEIMARK, P.L.L.C.;624 NINTH STREET, NW
SUITE 300
WASHINGTON
DC
20001-5303
US
|
Assignee: |
Mayer; Esther
Ra'anana
IL
|
Family ID: |
37053790 |
Appl. No.: |
11/910330 |
Filed: |
March 30, 2006 |
PCT Filed: |
March 30, 2006 |
PCT NO: |
PCT/IL2006/000410 |
371 Date: |
October 1, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60666618 |
Mar 31, 2005 |
|
|
|
Current U.S.
Class: |
607/90 |
Current CPC
Class: |
A61N 2005/073 20130101;
A61N 2005/0605 20130101; A61N 2005/0607 20130101; A61N 2005/0652
20130101; A61N 2005/0663 20130101; A61N 2005/0644 20130101; A61N
5/0603 20130101; A61N 2005/0608 20130101; A61N 5/0624 20130101;
A61N 2005/063 20130101; A61N 2005/0606 20130101; A61N 2005/0611
20130101; A61N 2005/0659 20130101 |
Class at
Publication: |
607/90 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. A probe device for use in treatment of tissues lining a body
cavity, the device comprising a probe member having at least a
portion thereof carrying a plurality of light sources, at least
said portion of the probe member having dimensions and shape
suitable for insertion into said body cavity and for arranging
within the surface thereof a three-dimensional array of said light
sources, the light sources being configured and operable to
irradiate monochromatic or polychromatic optical energy outwardly
from said probe member.
2. The probe device of claim 1, wherein said at least portion of
the probe member has tampon-like configuration.
3. The probe device of claim 1, wherein said light sources carried
by the probe member have one of the following configurations: (a)
comprise light emitting units; (b) comprise optical windows
optically coupled to one or more light emitting units located
outside the probe member or said portion of the probe member.
4. (canceled)
5. The probe device of claim 1, wherein said light sources carried
by the probe member are light emitters comprising the
three-dimension array of LEDs.
6. A probe device for use in treatment of tissues lining a body
cavity, the device comprising a probe member having at least a
portion thereof carrying a plurality of light emitters, at least
said portion of the probe member having dimensions and shape
suitable for insertion into the body cavity and for arranging
within the surface thereof a three-dimensional array of said light
emitters comprising the three-dimension array of LEDs arranged
within an electronic device configured for wrapping said at least
portion of the probe member, the light emitters being configured
and operable to irradiate optical energy outwardly from said probe
member.
7. The probe device of claim 6, wherein said electronic device has
at least one of the following configurations: (i) comprises a
printed circuit board; and (ii) is configured to be removable
mountable onto said at least portion of the probe member.
8. (canceled)
9. The probe device of claim 1, wherein said light sources carried
by the probe member comprise light emitting units, or optical
windows optically coupled to one or more light emitting units
located outside the probe member or said portion of the probe
member, the light emitting unit comprising at least one of the
following: flash lamp, laser, light emitting diode (LED).
10. (canceled)
11. The probe device of claim 1, wherein said sources carried by
the probe member comprise light emitting units, or optical windows
optically coupled to one or more light emitting units located
outside the probe member or said portion of the probe member, light
emitting unit comprising a plurality of light emitters producing
light of different wavelengths.
12. The probe device of claim 1, wherein said light sources carried
by the probe member comprise optical windows optically coupled to
one or more light emitting units located outside the probe member
or said portion of the probe member, the optical coupling
comprising an optical fiber connector.
13. The probe device of claim 12, having one of the following
configurations: (1) each of the optical windows is optically
coupled to a dedicated segment of the optical fiber connector; and
(2) an optical fiber of said optical fiber connector couples light
to more than one of said optical windows.
14.-16. (canceled)
17. The probe device of claim 1 comprising: an illumination
controller configured and operable for adjusting one or more of the
following operational parameters: an operational mode of each of
the light sources to provide serious of pulses and/or
continuous-wave mode of illumination, a duration of each light
pulse, an interval between adjacent pulses, a period and number of
pulses, an intensity of the illuminating light, wavelengths of the
illuminating light, polarization of light, and a duration of the
illumination process.
18. The probe device of claim 6, comprising an illumination
controller configured and operable for adjusting one or more of the
following operational parameters: an operational mode of each of
the light sources to provide serious of pulses and/or
continuous-wave mode of illumination, a duration of each light
pulse, an interval between adjacent pulses, a period and number of
pulses, an intensity of the illuminating light, wavelengths of the
illuminating light, polarization of light, and a duration of the
illumination process, said illumination controller comprising a
mixer utility for mixing light of different wavelengths to obtain a
desired wavelength at the output of each of the light sources.
19. The probe device of claim 6, comprising an illumination
controller configured and operable for adjusting one or more of the
following operational parameters: an operational mode of each of
the light sources to provide serious of pulses and/or
continuous-wave mode of illumination, a duration of each light
pulse, an interval between adjacent pulses, a period and number of
pulses, an intensity of the illuminating light, wavelengths of the
illuminating light, polarization of light, and a duration of the
illumination process, said illumination controller being configured
and operable to provide a predetermined sequence of wavelengths to
at least one of the light source to thereby enable sequential
illumination with different wavelengths at least a specific
location on the tissue.
20. A probe device for use in treatment of tissues lining a body
cavity, the device comprising a probe member having at least a
portion thereof carrying a plurality of light emitters, at least
said portion of the probe member having dimensions and shape
suitable for insertion into said body cavity and for arranging
within the surface thereof a three-dimensional array of said light
sources, the light sources being configured and operable to
irradiate optical energy outwardly from said probe member, said
three-dimensional array of the light sources comprising a plurality
of sub-arrays of the light emitters, said sub-arrays being arranged
one after the other along or across the probe member, each of the
sub-arrays being operable with different illumination
conditions.
21. A probe device for use in treatment of tissues lining a body
cavity, the device comprising a probe member having at least a
portion thereof carrying a plurality of light emitters, at least
said portion of the probe member having dimensions and shape
suitable for insertion into said body cavity and for arranging
within the surface thereof a three-dimensional array of said light
sources, the light sources being configured and operable to
irradiate optical energy outwardly from said probe member, said
optical energy from said light sources having one or more
wavelengths in the range from about 300 nm to about 1200 nm.
22. The probe device of claim 6, wherein said optical energy from
said light sources has one or more wavelengths in the range from
about 300 nm to about 1200 nm.
23. (canceled)
24. A probe device for use in treatment of tissues lining a body
cavity, the device comprising: a probe member having at least a
portion thereof carrying a plurality of light emitters, at least
said portion of the probe member having dimensions and shape
suitable for insertion into said body cavity and for arranging
within the surface thereof a three-dimensional array of said light
sources, the light sources being configured and operable to
irradiate optical energy outwardly from said probe member; and a
control unit connectable to said at least part of the probe member
carrying the light sources, the control unit comprising a memory
utility for storing reference data defining the operational mode of
the light sources per a user's treatment program, a data processor
for operating the illumination via an illumination controller
utility, and a user interface.
25. The probe device of claim 24, wherein the illumination
controller is configured and operable for adjusting one or more of
the following operational parameters: an operational mode of each
of the light sources to provide series of pulses and/or
continuous-wave mode of illumination, a duration of each light
pulse, an interval between the adjacent pulses, a period and number
of pulses, an intensity of the illuminating light, wavelengths of
the illuminating light, and a duration of the illumination
process.
26. A treatment kit comprising a set of a predetermined number of
disposable tampon-like probe members, each comprising the probe
device of claim 5 and being configured and operable to irradiate
monochromatic or polychromatic optical energy outwardly from the
respective probe member; and instructions for using said disposable
tampon-like probe members for treatment of a woman's vagina.
27. (canceled)
28. A method for photobiomodulation of a body cavity having a wall,
the method comprising illuminating at least part of said wall with
monochromatic or polychromatic optical energy using the probe
device of claim 1.
29. (canceled)
30. A method for photobiomodulation of a body cavity having a wall,
the method comprising illuminating at least part of said wall with
optical energy, utilizing modulation of one or more of the
following parameters: increase in mucous secretion at said body
cavity; increase in elasticity of the wall of said body cavity;
increase in firmness of the wall of said body cavity; increase of
blood circulation in blood vessels adjacent to the wall of said
body cavity; decrease in diameter of said body cavity.
31. A method for photobiomodulation of a body cavity having a wall
by illuminating at least part of said wall with optical energy, the
method comprising: providing a hand-held device configured as the
device of claim 6; inserting said at least part of the probe member
into a body cavity via an orifice of the body cavity such that a
part of the probe member is located close to said orifice of said
body cavity and is accessible to a user; actuating said hand-held
device to illuminate at least a part of the inwall of said body
cavity by said optical energy.
32.-33. (canceled)
34. The method of claim 30, wherein said body cavity is selected
from the vagina, anus, nostril or lacrimal duct.
35.-36. (canceled)
37. The method of claim 30, comprising a single or a plurality of
illumination sessions of the wall of the body cavity with optical
energy, said plurality of illumination sessions being of the same
or different illumination conditions.
38.-53. (canceled)
Description
FIELD OF THE INVENTION
[0001] This invention is in the field of photobiomodulation, and
relates to an optical probe device, system and method for affecting
tissue by light.
BACKGROUND OF THE INVENTION
[0002] Photobiomodulation covers a wide range of topics that are
important to all living creatures. One such topic includes
photomedicine, the studies of both the detrimental effects of light
as well as the beneficial effects of light (e.g. phototherapy or
light therapy).
[0003] For the past two decades, the medical properties of light
have been investigated rigorously, both in the laboratory and in
the clinic, to delineate its mechanisms and potential clinical
applications. It has been established that light interferes with a
number of cellular processes, including protein synthesis (e.g.
collagen production), cell growth and differentiation, cell
motility, membrane potential and binding affinities,
neurotransmitter release, ATP synthesis, and others, similar to
photosynthesis in plants. Further, different wavelengths have been
shown to produce different healing effects at the biochemical,
cellular, histological, and functional levels.
[0004] Whether using low intensity radiation in the visible,
filtered ultraviolet or near infrared region from a laser, or a
filtered incandescent lamp, phototherapy was shown to be beneficial
in a number of clinical situations, from pain remission, to wound
healing.
[0005] For example, external phototherapy has been shown effective
in treating various acute and chronic medical conditions. For
example, certain light spectra are effective in treating severe
second degree burns, leg ulcers, bulimia nervosa, herpes,
psoriasis, eczema, seasonal affective disorder, sleep disorders,
acne, skin cancer, inflammatory and autoimmune conditions such as
rheumatoid arthritis and deep tissue inflammation, muscular
strains, varicose veins, rosacea, and other conditions. One of the
conditions most widely treated with phototherapy is
hyperbilirubinemia in newborn infants, typified by an elevated
level of a toxic molecule known as bilirubin in the infant's
blood.
[0006] A blue light LED system which has received clearance from
the U.S.A. Food and Drug Administration (FDA) is used for treating
a range of skin conditions including moderate inflammatory acne
vulgaris and various oral diseases such as stomatitis and
gingivitis.
[0007] In addition, photobiomodulation is widely used for cosmetic
applications, e.g. for skin rejuvenation and wrinkle smoothing.
[0008] European Patent No. 0 763 371 describes a method and
apparatus for treating skin by applying pulsed light to the skin to
heat and shrink collagen within the skin, thereby reviving the
elasticity of the collagen and of the skin. The epidermis and outer
layers of the skin may be protected by cooling with a transparent
substance, such as ice or gel, to the skin. The temperature
distribution within the skin is controlled by controlling the delay
between the time the coolant is applied, and the time the light is
applied, by controlling the pulse duration and applying multiple
pulses, and by filtering the light and controlling the radiation
spectrum. The spectrum includes the light having a wavelength in
the range of 600-1200 nm. The pulsed light may be incoherent, such
as that produced by a flashlamp, or coherent, such as that produced
by a Nd(Yag) laser or a ruby laser, and may be directed to the skin
using a flexible or rigid light guide.
[0009] In addition, Light Bioscience has developed methods where
electromagnetic radiation, in particular, light, is used to
photobiomodulate the activity of living cells to delay, diminish,
retard or even reverse the structural and functional effects of
aging of the living cells and tissues (e.g. skin cells, hair) as
well as for the treatment of acne, as also described in WO
05/011606, WO 03/017824 and WO 00/032121.
[0010] WO 00/032121 describes a system for producing preferential
damage to hair exiting mammalian skin. An agent having an average
diameter for enabling the agent to penetrate the hair duct is
selected. The agent is designed to attach to, or become physically
incorporated into, the hair shaft, the hair follicle, the hair bulb
or the hair duct. The agent has an electromagnetic radiation
absorption characteristic which enables the agent to absorb a first
wavelength of electromagnetic radiation from a skin-penetrating
electromagnetic radiation source, such as a laser. The agent is
applied to the skin so that the agent penetrates the skin and
attaches to or becomes physically incorporated into the hair shaft,
the hair follicle, the hair bulb or the hair duct. The agent is
exposed to the first wavelength of electromagnetic radiation and
absorbs the first wavelength of electromagnetic radiation.
[0011] According to the technique of WO 03/017824, skin disorders
are treated by applying a photomodulation enhancing agent to the
skin proximate to or directly to a target living tissue; and
exposing the photomodulating enhancing agent to a source of
electromagnetic radiation. The latter has at least one dominant
emissive wavelength between about 300 nm and about 1400 nm. The
source of electromagnetic radiation is selected from an ultrasound
radiation emitter, a light emitting diode, a laser diode, a dye
laser, metal halide lamps, a flashlamp, a mechanically filtered
fluorescent light source, a mechanically filtered incandescent or
filamentous light source, or combinations thereof. The
photomodulation enhancing agent has an absorption characteristic at
said dominant emissive wavelength selected to cause the inhibition
of, reduction in size of, or the destruction of said target
tissue.
[0012] The technique WO 05/011606 is aimed at improving the
appearance, structure, function of aging skin, including up and
down regulating the genotypic markers for the phenotype of aging
skin. More than one light source of narrowband, multichromatic
electromagnetic radiation is used, wherein at least one light
source emits radiation at a wavelength corresponding to yellow
light and at least one light source emits radiation corresponding
to infra-red light.
SUMMARY OF THE INVENTION
[0013] There is a need in the art to facilitate reconstitution of
tissue lining walls of body cavities, having an orifice on the
external surface of the body and an inner wall covered by
biological vital cell containing tissue, for example vagina,
rectum, nostrils, oral cavity, etc. For example, when the body
cavity is the vagina, there is a need to provide means for the
rejuvenation of vaginal wall, which includes increasing
flexibility, elasticity and firmness of the vaginal wall, resulting
in the decrease in the internal vagina diameter. Moreover, there is
a need in the art for a treatment device of a simple configuration
to be operated by user and/or by the physician, allowing the device
or at least that part thereof which is brought in adjacency with
the body cavity to be disposable, as well as ensuring reliable
device operation which is painless, non ablative and has no danger
to the patient's body (e.g. no excessive heating of the tissue, no
cancerogenic effect, sterile), as well as eye safe to the patient
and physician.
[0014] The present invention is based on the understanding that
collagen and elastin included in the sub-mucosal layer covering
body cavities contribute to the elasticity and tone of these
cavities. Their breakdown and disruption through, for example, the
aging process, birth giving (when the body cavity is the vagina),
the existence of a pathological condition (e.g. inflammation or any
other disease or disorder) etc. may result in loss of tightness and
flexibility of the wall of the respective body cavity. Loss of
tightness and flexibility may have impact on the wellbeing
(physical as well as mental) of the subject suffering from the
condition. Thus, there is interest in providing means for
rejuvenation and reconstruction of the cavity's wall. With vaginal
relaxation, the muscles are relaxed and have poor tone, strength,
and control. The internal and external diameters increase. Under
these circumstances, the vagina is no longer at its optimum
functional state. As a result, the sensual side of sexual
fulfillment is diminished
[0015] In general, the present invention concerns a device, a
system and a method for photobiomodulation, utilizing illumination
of the walls of a body cavity with low-intensity light of one or
more specific wavelengths within the visible spectral range. The
term "photobiomodulation" relates to the use of light to induce an
effect on a biological tissue or cell as well as deep into the
tissue at the illuminated area. The effect may be the induction,
stimulation or inhibition of a biochemical process so as to
optimize inter alia, one or more of blood circulation within the
tissue, oxygen supply, regulation of tissue functions, cell
metabolism, cell respiration, cell renewal, tissue development and
stability, tissue elasticity, tissue protection, tissue suppleness,
and moisturizing of the tissue. The illumination results, inter
alia, in a therapeutic beneficial effect, as detailed below.
[0016] According to the invention, a plurality of light emitters is
used being arranged in an array along a housing (probe). The
illumination may or may not be monochromatic, i.e. it may include
mono or polychromatic light. The term monochromatic denotes a
single wavelength (single color) while the term polychromatic
denotes two or more wavelengths (two or more colors, e.g. red and
blue). The illumination may be applied in continuous wave (CW)
mode, or may be applied in a pulse mode at either fixed or variable
frequency.
[0017] Generally, suitable light sources may include but are not
limited to LEDs and lasers. Preferably, the invention utilizes
LEDs, especially because they are low-intensity light sources which
on the one hand cannot apply extra heating to the tissues under
treatment which is essential when dealing with treatment inside a
body cavity, such as vagina treatment, and on the other hand do not
need to be cooled. Comparing the use of LED illumination for
treatment of tissues with that of laser illumination, the following
should be noted. Led illumination, while it might need a greater
treatment time, provides for concurrently illuminating the entire
region of interest rather than a point-like location; provides a
more safe treatment; does not apply thermal energy to the tissue;
and provides for affecting multiple types of tissues. The use of
LEDs for treatment is relatively "non invasive", using a non
coherent light.
[0018] The use of an array of spaced-apart LEDs when arranged close
to the tissue region to be treated provides for substantially
uniform illumination of the entire treatment region, eliminating a
need for light collecting optics. For example, LEDs of primary
colors, RGB, may be used to treat specific medical conditions by
affecting biochemical processes within a biological cell or a
tissue.
[0019] It should also be noted that, generally, a single
high-intensity, and preferably broadband, light source (e.g. LED)
can be used for illuminating a region in the vicinity thereof. This
can utilize a high divergence of light emitted from the LED, or
reflector/diffuser can be used at the LED output to direct the
emitted light to the large target area. Also, when using more than
one LED, a reflector/diffuser can be appropriately provided.
[0020] It should be noted that the invention may utilize a suitable
polarizer unit for increasing the part of the emitted light
effectively applied to tissue.
[0021] In some embodiments of the invention, single wavelength
light (generally, narrow wavelength range) is applied to a
biological tissue covering the inner wall of a body cavity, as the
desired cellular response is heightened when a narrow wavelength
band is applied. In some other embodiments of the invention a
plurality of wavelengths are applied to the tissue. Since the
problem to be solved by the vaginal treatment for example is a
result of multi factorial variables (relaxation, dryness etc.), the
treatment should preferably be a combination of photomodulation
sequential treatments in order to achieve maximal benefit.
[0022] For example, when treating vaginal relaxation there is a
need to, on the one hand, enhance collagen and elastin production,
and on the other hand increase blood circulation. Therefore, a
single wavelength or a combination of multiple wavelengths applied
in a sequence can be used. The technique disclosed herein may
utilize white-color LEDs operable to emit short pulses of light of
predetermined duration and period.
[0023] For example, a therapeutic effect can result from applying
light with a narrowband of wavelengths centered about a dominant
wavelength. The energy level for this process may for example be
from about 200 mW/cm.sup.2 to less than about 1000 mW/cm.sup.2. In
this specific but not limiting example, the exposure of the tissue
to light is carried out by pulsing light with a period of pulses of
less than 1 s, and the pulse duration from about 150 ms to about
850 ms.
[0024] Thus, in accordance with a first aspect of the present
invention there is provided a device for use in treatment of
tissues lining a body cavity, the device comprising a probe member
having at least a portion thereof carrying a plurality of light
sources, at least said portion of the probe member having
dimensions and shape suitable for insertion into a certain body
cavity and for arranging within the surface thereof a
three-dimensional array of said light sources the light sources
being configured and operable to irradiate optical energy outwardly
from said probe member.
[0025] The term "probe member" or "probe" as used herein actually
refers to an illuminating unit and is thus used interchangeably
with the term "illuminator". The probe portion carrying the light
sources may be appropriately curved, may have a symmetrical
cylindrical shape, an eggplant shape, as well as other shapes
suitable for insertion into a body cavity; or may have a
substantially rectangular cross section (e.g. with round edges or
not) carrying the light sources at least within two opposites
surfaces of the probe portion by which it faces the opposite inner
walls of the body cavity when the device is in operation.
[0026] The "light source" carried by the probe member may be
constituted by a light emitting element itself or by an optical
window coupled (e.g. by fiber) to a light emitting element located
outside the probe member or outside the portion of the probe member
carrying the light source. The light emitting element is preferably
a light emitting diode (LED), or can be a chemical light source,
i.e., a chemiluminescent substance, for transmitting cool light
energy into the body tissue.
[0027] In one embodiment of the invention, primary colors, red,
green or blue or any combination of them, is employed. Blue and red
light can generally be provided by an incandescent lamp or other
suitable lamp, a LED, a combination of LEDs, a laser or chemical
light source with preferred wavelengths predominantly between about
300 nm to about 1200 nm, and more preferably between about 300 nm
to about 800 nm. It should be noted that different monochromatic
light components may have different effects on a biological tissue.
For example, red light affects blood circulation within the exposed
tissue site (Ref 16.). Thus, exposure of the inner wall of a body
cavity to red light may increase blood circulation at the treated
site. Further, blue light has an effect on bacteria and thus may be
used to treat pathogen infections. Yet, yellow light has an effect
on tissue rejuvenation.
[0028] Thus, in accordance with the invention, mono- as well as
polychromatic light may be used to achieve one or more desired
effects.
[0029] The term "body cavity" as used herein denotes any body
cavity having an orifice on the external surface of the body and an
inner wall covered by biological vital cell containing tissue. In a
typical mammalian body such as the human body, the body orifices
include the nostrils, the lacrimal ducts, the ears the mouth, the
anus, nipples and breast ducts, secreting glands, the urethra, the
uterine cervix canal, and the vagina.
[0030] The invention is particularly useful for affecting the
tissue lining the inner walls of the vagina, the anus, the nostrils
and the lacrimal ducts as well as deeper within the tissue. The
invention is mainly intended for treatment of the inwall of the
body cavity of the kind comprising a mucous membrane and submucous
layer.
[0031] As appreciated, all body surfaces and cavities are covered
by epithelial cells and there are numerous types of epithelial
cells within the body: Simple squamous epithelium; Simple cuboidal
epithelium; Simple columnar epithelium; Pseudostratified columnar
epithelium; Stratified squamous epithelium (The keratinized
(cornified) type and the nonkeratinized (noncornified) type);
Stratifed cuboidal epithelium; and Transitional epithelium. While
the skin mainly comprises keratinized stratified squamous
epithelium, it is noted that body cavities, which are the subject
of the present invention, typically comprise nonkeratinized
(noncornified) type epithelial cells (also called mucous membrane).
Thus, in the context of the present invention, the wall of body
cavities are those which mainly and essentially comprise mucous
membrane and submucous layer.
[0032] The term "mucous membrane" refers to the lining of
ectodermic origin, covered in epithelium (nonkeratinized
(noncornified) type epithelial cells) and is involved in absorption
and secretion. The mucous membrane lines various body cavities that
are exposed to the external environment and internal organs. In the
context of the present invention, the mucous membrane includes the
nasal mucosa, the oral mucosa including the buccal and labial
mucosa, the mucosa of the ear, the mucosa of the eye (e.g. lining
the walls of the lacrimal duct), the rectal mucosa, the anal
mucosa, and the genital mucosa, preferably, the mucosa at the
vagina.
[0033] The invention also provides a system for photobiomodulation
of a body cavity. The system comprises the above-described probe
and a control unit. The control unit comprises an illumination
controller configured and operable for adjusting at least one of
the following operational parameters: an operational mode of the
light emitter (located on the probe member or outside thereof and
optically coupled thereto) to provide either one of the pulse and
continuous-wave mode of operation for each wavelength used, a
duration of the light pulse, a period of pulses, an intensity of
the emitted light, wavelengths of the emitted light, and a duration
of the illumination.
[0034] The illumination controller is a hardware and/or software
utility preprogrammed for controlling one or more of the above
parameters.
[0035] The device of the present invention is preferably configured
as a hand-held unit including said probe member carrying the
three-dimensional array of light sources, and a handle portion. The
control unit may be entirely incorporated within the hand-held
device, or may be an external unit connectable to the device, or
the utilities of the control unit may be distributed between the
probe device and the external unit (thus generally, the control
unit may be at least partially incorporated within the hand-held
device).
[0036] In yet a further aspect of the invention there is provided a
method for treating a body cavity, by exposing at least a part of
said body cavity wall to optical energy. According to a preferred
embodiment of the invention, it is intended for treatment of said
the body cavity wall of the kind comprising mucous membrane and a
submucous layer; and the effect of illumination comprises a
photobiomodulation of said mucous membrane cells and/or a submucous
layer.
[0037] Thus, in accordance with the invention there is also
provided a method for increasing mucous secretion within a body
cavity having an inner wall, the method comprising illuminating at
least a part of said body cavity wall with an optical energy while
controlling at least one of the following parameters of
illumination: either one of the pulse and continuous-wave mode of
operation for each wavelength used, a duration of the light pulse,
a period of pulses, an intensity of the emitted light, wavelengths
and/or polarization of the emitted light, and a duration of the
illumination.
[0038] In accordance with one embodiment, the method comprises:
[0039] providing a hand-held device comprising a probe member
carrying a plurality of light sources, the probe member having
dimensions and shape suitable for insertion at least a portion of
the probe member into the certain body cavity and for arranging a
three-dimensional array of said light sources within said at least
portion of the probe member, the light sources being configured and
operable to irradiate optical energy outwardly from said probe
member;
[0040] inserting said at least part of the probe member into a body
cavity via an orifice of the body cavity such that a part of the
probe member is located close to said orifice of said body cavity
and is accessible to a user; and
[0041] actuating said hand-held device to illuminate at least a
part of the inwall of said body cavity by said optical energy.
[0042] During the device operation, at least one of the following
parameters is controlled: an operational mode of the light source
to provide either one of pulse and continuous-wave mode of
operation, a duration of the light pulse, a period of pulses, an
intensity of the emitted light, wavelengths and/or polarization of
the emitted light, and a duration of the illumination.
[0043] Illumination of cells and tissues may affect numerous
biochemical changes in cellular membrane and intracellular and
intercellular content. A monochromatic or polychromatic light,
pulsed or continuous light may stimulate cytochromes in the body's
tissue, which increase the energy metabolism of the cells,
maximizing cell activity of damaged, aged or distressed tissue. The
activity may occur both within the cell through a rapid increase of
protein and calcium production, and between the cells by the
improvement of cellular membrane channels and gap junctions via the
increased production of protein resulting in enhanced blood
circulation, fibroblastic activity and collagen and elastin
production.
[0044] Further, in the mitochondria, enhanced ATP (adenosine
triphosphate)-ADP (adenosine diphosphate) metabolism, may increase
ATP content or a growth of the electric potential across inner
membranes which in turn may lead to cellular activation and RNA and
DNA synthesis, as appropriate. Moreover, growth factor response
within the cells and tissues may be increased as a result of
enhanced ATP and protein synthesis.
[0045] Thus, some beneficial effects of radiation may include,
without being limited thereto and in addition to those already
described hereinabove, accelerated regeneration of damaged tissue
and improvement of blood circulation (e.g. due to vasodilation);
beneficial development of new blood vessels; enhancement of
cellular activity, such as of fibroblasts and phagocytes (which may
be effective against infection or inflammation); enhancement of
cell division and cell growth (such as of fibroblasts and
phagocytes); stimulation and increasing support for the
multi-production of protein production such as collagen and elastin
fibers; enhancement of important specific enzymes involved in cell
regeneration; pain relief as a result of endorphin release;
immunostimulation due to, for example, increase in lymphocyte
activity; or to provide an anti-inflammatory and/or anti edematous
effect, increase of serotonin synthesis and secretion improving
seasonal depression and postpartum blues.
[0046] In addition, radiation of the inner wall of a body cavity
according to the invention may stimulate mucosal fluid or moist
secretions of otherwise abnormally dried cavities or when such
stimulation is desired.
[0047] It is well appreciated that the method may be applicable for
the treatment of a variety of conditions which require for said
treatment build up and reconstitution of an inwall of a body cavity
as well as for the treatment of pathological conditions.
[0048] The term "treatment" in accordance with the invention is
used to denote an effect of radiation on the structure and/or
function of a body cavity as a result of a single or sequence of
illumination sessions of the body cavity. Treatment may have a
healing as well as a prophylactic effect on a damaged or distressed
tissue forming the cavity's inwall leading to the elimination,
inhibition or arrest in progression of any damage caused to said
inwall, as well as relief in symptoms associated with damaged
cavity inwall. Affected cavity wall may be a result of aging of the
tissue lining the wall (exhibited by, inter alia, reduced tissue
vitality, elasticity and tissue tone dryness and irritability) or
as a result of a pathological condition associated with the tissue
lining the wall (inflammation, trauma etc.).
[0049] As already noted above, treatment by optical energy
increases cell activity of damaged or distressed tissue. The
activity occurs both within the cell through a rapid increase of
protein and calcium production and between the cells by the
improvement of the cellular membrane channels and gap junctions via
the increased production of protein, resulting in enhanced blood
circulation, fibroblastic activity and collagen and elastin
production. However, it is worth noting that light does not exert
its beneficial action only on the site being exposed to light, but
also through gentle stimulatory action on blood coursing through
the fine capillaries under the tissue lining the body cavity being
treated thereby increasing the supply of vital oxygen and energy to
every cell.
[0050] According to one preferred embodiment, treatment
(illumination of a body cavity) results in the reconstitution of
the wall of the cavity. The term "reconstitution of a cavity wall"
as used herein denotes not only the densification of the connective
tissue constituting the wall (e.g. by stimulation the production of
collagen and elastin) leading to the tightening of the wall, but
also, and at times preferably, to the healing of mucous membrane
lining the wall, so as to management of mucous secretion of an
otherwise dry, tender and sore cavity.
[0051] Treatment in accordance with the invention may also include,
in addition or alternatively, a healing or preventative effect on a
pathological condition.
[0052] The term "pathological condition" denotes any ailment
associated the tissue lining a body cavity, the treatment of which
is not considered mere cosmetic treatment. This includes, inter
alia, a condition selected from degenerative conditions caused by
the aging process, inflammation, infection, vascular disorders, and
many others, as known in the art. For example, the effect of
radiation on a pathological condition (observed by accelerated
regeneration of damaged tissue in the cavity and improvement of
blood circulation in the cavity) may be associated with increased
activity of certain cells like fibroblasts and phagocytes; enhanced
cell division and cell growth; activation of the synthesis of
proteins; improved blood circulation due to relaxation of vessel
walls (vasodilation); reduced pain, swelling, inflammation and
irritation; stimulated endorphins and serotonin and stimulation of
healing processes; as well as reduction of mutated cells.
[0053] Treatment in accordance with the invention may include, in
addition to the illumination of the wall of the cavity, topical
application of a substance, such as a suitable photo-sensitizer.
One example of a photo-sensitizer is 5-Aminolevulinic acid (ALA).
The photo-sensitizer will typically be applied to the wall of the
cavity before illumination (e.g. manually or by the aid of a
suitable syringe). As appreciated, treatment may also be in
combination with topical application of a therapeutic active agent,
such as a drug or a pro-drug (e.g. a chemical compound which
transforms into its active form once applied to the tissue, or as a
result of illumination) or an immunostimulator, as known in the
art.
[0054] It is noted that the topically applied active agents may
have a local as well as systemic effect. Exposure of the inner wall
of a cavity to light may thus result in an increased absorbance of
the active agent by the tissue and thus increased blood levels of
the agent. This is of particular interest in the case of intranasal
administration of vaccines and fertility agents and various
drugs.
[0055] It is noted that in accordance with the invention an effect
may be achieved, without using thermal injury as a trigger for
achieving the desired effect.
[0056] According to one embodiment, treatment comprises
illumination the wall of a body cavity with a monochromatic
light.
[0057] According to another embodiment, treatment may include
illumination of the wall of the body cavity with a combination of
monochromatic lights. The cavity may be exposed to the combination
of lights at the same time, e.g. by using a probe having different
types of light sources mounted thereon; or at different treatment
sessions, e.g. by using probes with different light sources, such
as a first probe providing red light and thereafter, in a following
treatment session, providing a probe illuminating blue light.
[0058] Treatment may include a single treatment session, i.e. a
single illumination session which may vary in duration (from
seconds to minutes) or plurality (two or more) illumination
sessions (e.g. illumination in pulses). When applying a plurality
of illumination sessions, different lights may be applied in a
single treatment session. Thus, for example, a single treatment
session may include a combination of illumination sessions of
different wavelengths, at a predetermined sequence. In addition,
treatment may comprise a combination of a continuous illumination
of a selected wavelength concomitant with pulsed illumination of a
different wavelength.
[0059] Treatment may be a daily treatment, may include one or more
illumination/treatment sessions per day, and may extend to more
than one day of treatment, at times for a period of several
months.
[0060] According to one embodiment, a treatment session may last
for example 10 minutes during which the body cavity is subjected to
a continuous or pulsed optical energy. It is noted that during a
treatment session, a body cavity may be illuminated by a
combination of wavelengths, some being continuous and some,
pulsated.
[0061] Treatment efficacy will be determined by one or more
suitable parameters known in the art and may include, for example,
physical examination of the treated subject as well as the general
feedback received from the subject (e.g. by using a suitable
questionnaire provided to the subject).
[0062] As appreciated by those versed in the art of gynecology,
aging as well as birth giving may lead to loosening of the vaginal
wall, vaginal enlargement and vaginal dryness. This typically
results in a woman's sexual dysfunction and dissatisfaction during
intercourse, as well as other discomforts such as the presence of
bad odors and male partner dissatisfaction.
[0063] Female sexual dysfunction is a complex process, coordinated
by the neurologic, vascular and endocrine systems. Individually,
sexuality incorporates family, societal and religious beliefs, and
is altered with aging, health status and personal experience. In
addition, sexual activity incorporates interpersonal relationships,
each partner bringing unique attitudes, needs and responses into
the coupling. A breakdown in any of these areas may lead to sexual
dysfunction. Sexual dysfunction can be subdivided into desire,
erozal, orgasmic and sexual pain disorders. Sexual dysfunction may
result from unsatisfying encounter or inadequate stimulation which
may lead to a decrease in one or more of the following decreased
orgasm, decreased desire, decreased arousal, painful sex, etc.
[0064] Thus, according to one embodiment, the method comprises
illuminating at least a portion of the vaginal wall with optical
energy for the reconstitution (rejuvenation) of the wall of the
vagina. Rejuvenation includes, inter alia, increase in elasticity
and firmness of the body wall, enhanced tone, strength, and
control. It will effectively decrease the internal and outer
(introitus) vaginal diameters, as well as build up the perineal
body (the area immediately outside the vaginal and above the anus.
Treatment also provides an aesthetic enhancement of the external
vaginal structures, resulting in a more youthful look. Treatment
also has an important impact on a woman's sexual satisfaction.
[0065] In accordance with another preferred embodiment, treatment
may include, in addition or alternatively, alleviating ailments
within the vagina, such as inflammation, and infections known as
bacterial vaginosis.
[0066] Any one or a combination of the following effects may be
observed following exposure of vaginal wall with optical energy, as
disclosed herein: tightening of the vaginal canal; enhancing
collagen and elastin production; improving blood circulation within
the vaginal wall; moistening of the vaginal canal leading to
reduced soreness and thus to enhanced sexual sensitivity; reducing
vaginal irritation.
[0067] In accordance with another embodiment, the invention
provides treatment by exposure to light of internal and external
hemorrhoids. Hemorrhoids are painful, swollen veins in the lower
portion of the rectum or anus. Internal hemorrhoids occur just
inside the anus, at the beginning of the rectum, while external
hemorrhoids occur at the anal opening and may hang outside the
anus. Hemorrhoids, internal as well as external, are often
inflammed. Thus, by exposing hemorrhoids to optical energy, one or
more of the following may occur: increased blood circulation;
improved in lymphatic drainage; improved phagocyte activity;
increased collagen and elastin production; etc, thereby leading to
treatment of hemorrhoids.
[0068] In accordance with yet another embodiment, the method
provides photobiomodulation of tissue lining the intranasal wall,
including, aged intranasal cavity, moisten dry nasal membranes
which may cause discomfort, soreness, congested breathing, and even
bleeding and the associated possibility of nasal infections. In
addition, exposure of the intranasal wall to optical energy may
lead to increase in blood circulation and vasodilatation at the
wall, which may increase intra-nasal absorption of medicaments. As
indicated above, this may be of particular interest for the
intranasal delivery of vaccines and fertility agents and drugs.
[0069] In accordance with yet another embodiment, the invention
provides photobiomodulation of tissue lining the inwall of lacrimal
duct. This may be of significance for treating lacrimal duct
infection (dacrocyocystitis), congenital lacrimal duct obstruction
(tear duct obstruction) and the like, which may lead to infection
and inflammation.
[0070] Further, in accordance with a preferred embodiment, the
invention concerns photobiomodulation of tissue lining the gums in
the oral cavity. One particular desired effect is for preventing or
treating Gingivitis. Gingivitis is a form of periodontal disease
wherein inflammation and infection destroy the tissues that support
the teeth, including the gingiva (gums), the periodontal ligaments,
and the tooth sockets (alveolar bone). Illumination of the inflamed
gums, in accordance with the invention may result in reduced
inflammation and faster healing of the gums.
BRIEF DESCRIPTION OF THE DRAWINGS
[0071] In order to understand the invention and to see how it may
be carried out in practice, a preferred embodiment will now be
described, by way of non-limiting example only, with reference to
the accompanying drawings, in which:
[0072] FIGS. 1A-1B schematically illustrate an example of a
hand-held probe device configured and operable according to the
invention for treating the wall of a body cavity;
[0073] FIG. 2 schematically illustrates a typical LED configuration
suitable to be used in the device of the present invention;
[0074] FIGS. 3A and 3B illustrate schematically another example of
the probe device of the present invention, where an array of
optical windows, formed in the probe member and optically coupled
to external light emitter(s), constitute an array of light
sources;
[0075] FIG. 3C schematically illustrates yet another example of a
probe device of the present invention, equipped with an orifice
abutment skirt at the DISTAL end of the probe member;
[0076] FIG. 3D shows an example of the device of the invention
configured to define different groups of light sources producing
light components of different wavelengths, respectively;
[0077] FIGS. 3E and 3F show two more examples, respectively of a
probe member configuration suitable to be used in the probe device
of the present invention;
[0078] FIG. 3G exemplifies a treatment kit for treatment of a
woman's vagina;
[0079] FIG. 4 exemplifies the configuration of a control unit
suitable to be used in the present invention for controlling one or
more parameters of the illumination; and
[0080] FIGS. 5A-5B show graphs of the absorption spectrum of human
fibroblast cells in tissue culture, suitable for determining the
operational parameters of the probe device.
DETAILED DESCRIPTION OF SOME EMBODIMENTS
[0081] The following are examples of some different concepts which
are intended to describe some of the general design possibilities
of the probe, but are in no way intended to limit the scope
thereof. It is important to mention that the final shape of the
probe can differ from the examples given herein. It is deemed that
such designs can be modified in accordance with the specific
application and specific body cavity to be treated.
[0082] Reference is now made to FIGS. 1A and 1B illustrating
schematically a probe device 10 for use in photobiomodulation of a
body cavity in accordance with the invention. Device 10 comprises a
probe member 12 having a distal end 14 to be located at the body
cavity orifice when the device is put in operation and a proximal
end 16 by which it is to be inserted into a body cavity. Probe
member 12 carries a plurality of spaced apart light sources,
generally at 18, arranged along of the surface of the probe member
12. Probe member 12 is configured (has dimensions and shape)
allowing insertion of at least a part thereof into a certain body
cavity and is configured to arrange on the surface of said at least
portion of the probe member a three-dimensional array of the light
sources. The latter are configured and operable to irradiate
optical energy outwardly from probe member 12.
[0083] In the present non-limiting example, the probe member has a
tampon-like configuration, i.e., has a cylinder- or tubular-like
shape. As shown in FIG. 1A, proximal end 16 of such tampon-like
member 12 has generally a hemispherical surface with no outwardly
facing sharp points or edges so as to avoid inconvenient scraping
of the walls of the body orifice and cavity, when inserting the
probe via the cavity's orifice.
[0084] While in the specific embodiment illustrated in FIGS. 1A-1B
cylindrical- or tubular-like probe member 12 has a circular
cross-section, it is to be understood that the invention is not
limited to this specific example, and the probe member may
similarly function with an oval cross section, as well as be of a
conical or eggplant-like shape, as well as not necessarily having a
closed-loop configuration of its cross-section, etc.
[0085] As illustrated, probe device 10 has array of light sources
18. The term "array of light sources" denotes at least two,
preferably more, light sources. Light sources may be constituted by
light emitting elements themselves and (possible optics, such as
lenses and/or polarizers and/or light diffusers, e.g. the lens may
be implemented in a translucent diffusing material) arranged on the
probe member/carrier in spaced-apart locations, or by optical
windows (e.g. including optics, e.g. lenses and/or polarizers
and/or light diffusers, e.g. the lens may be implemented in a
translucent diffusing material) arranged in the spaced-apart
locations on the probe member/carrier and optically coupled to
external light emitting element(s) by light guides (fibers). This
will be described further below with reference to FIGS. 3A-3B. The
light sources may be randomly distributed or have a specific
distribution pattern, e.g. in radially, longitudinally and/or
diagonally arranged lines.
[0086] The probe member 12 or at least a apart thereof carrying the
light sources and intended to be inserted into the body cavity may
be made of a rigid or flexible material. Preferably, the probe
member is made of a relatively flexible material so as to reduce
the chances of inadvertent injury to the body cavity. The probe
member (or the outer cover as the case may be) is made of
biocompatible material such as polycarbonate, polypropylene, acryl,
and derivatives thereof, polyurethane, etc. as known in the
art.
[0087] As shown in the example of FIGS. 1A-1B, array of LEDs 18
(constituting light sources) is associated with a suitable
electronics, e.g. the LEDs are arranged within a printed circuit
board (PCB) film 20. The latter wraps at least a part of the outer
surface of the probe member 12. For example, such a PCB with LEDs
may be configured as a cover mountable onto at least a part of the
probe member. An electronic block 21 of the PCB arrangement is
located inside the probe member 12 as shown in FIG. 1B. The device
may be battery- or wall-powered, and permits convenient treatment
of the patient as an office procedure. Many wavelengths can be
used, depending on the type of treatment administered.
[0088] It is to be understood that any suitable LED configuration
known in the art may be used in the present invention. FIG. 2
schematically illustrates an example of LED 18 suitable to be used
in the device of the present invention. LED 18 includes a tubular
Anode post AP, a Cathode C, a LED chip LC (formed by a silver die
and attached gold wire bond on a top contact) inside the anode
tube, an epoxy dome lens L, and a lead frame LF.
[0089] As exemplified in FIG. 1B by dashed curve, member 12 with
LEDs 18 may be further coated by an external cover 22 made of a
suitable biocompatible material, which is transparent for the
spectral range(s) used, e.g. made of transparent latex. The cover
material may be diffusive to direct light output from the light
source to larger surface area. Preferably, such cover 22 is
configured to be removably mountable onto member 12, thus enabling
the cover to be disposable.
[0090] It should be noted that actually the entire probe carrying
the LEDs may be disposable. Alternatively, the probe member may be
configured as a two-part unit, where the two parts are
appropriately engageable/disengageable, and that part (distal) of
the probe which carries the LEDs (or optical windows as will be
described further below) and is intended to be engaged with the
body cavity (e.g. vagina) is disposable.
[0091] Turning back to FIG. 1A, probe 10 is appropriately formed
with a handle portion 13 located at the distal end 14 of probe
member 12. Also shown in FIG. 1A is a control unit 30 connectable
to probe device 10, preferably by wires, or wireless. The control
unit 30 is typically a computer system having inter alia such
utilities as memory 30A, data processor 30B for operating the
illumination via an illumination controller utility 30C, and a user
interface 30D (including display). Control unit 30 also includes a
battery power source (not shown) and/or a connector to a power
network.
[0092] The control unit includes suitable hardware and software,
and may be stored with certain reference data defining the
operational mode of the LEDs per the user's treatment program. The
latter includes for example the intensity of light, appropriate
wavelength(s), pulsed or continuous wave (CW) operation, pulse rate
and duration, duration of entire treatment session, as well as the
personal data, etc.
[0093] For example, the applied light may be of intensity
substantially not exceeding 1 Watt/cm.sup.2; and may be pulsed with
a period of about 1 ms, the illumination (treatment) duration may
for example be in a range from 10 seconds to 1 hour.
[0094] For example, LEDs array 18 may include LEDs with a
narrowband of wavelength centered about a dominant wavelength. The
energy level may for example be from about 200 mW/cm.sup.2 to less
than 1000 mW/cm.sup.2; the exposure of the tissue with light may be
carried out by pulsing light with a period of pulses of about 1 ms,
and the pulse duration from about 150 ms to about 850 ms.
[0095] It should also be noted, although not specifically shown,
that probe device 10 could be equipped with a sensor unit including
one or more sensors for sensing one or more conditions during the
treatment. This may include temperature, level of secretion,
chemical and biological sensors, etc.
[0096] Reference is made to FIGS. 3A and 3B illustrating
schematically another example of the probe configuration 100. To
facilitate understanding, the same reference numerals are used for
identifying components that are common in all the examples. FIG. 3A
shows a partial side view of the probe, and FIG. 3B shows the
cross-sectional view along line A-A in FIG. 3A.
[0097] Probe device 100 includes a cylindrical- or tubular-like or
tampon-like probe member (housing) 12 formed along its
circumference with an array of optical windows (e.g. apertures, or
regions of a material translucent for the spectral range(s) used,
and/or lenses) constituting light sources 18. An arrangement of
fibers (light guides), generally at 42, is provided for optically
coupling the optical windows to a light emitting unit 18A located
outside the probe member 12 or outside that part of the probe
member which is to be inserted into the body cavity. In the present
not limiting example, the light emitting unit is accommodated in a
control unit 30. As shown in FIG. 3B, each optical window is
coupled to its dedicated segment of the fiber.
[0098] It should be understood although not specifically shown that
the same fiber, that guides light of a specific color from an
external light emitter, may be associated with a plurality of
optical windows. This can be implemented by forming optical windows
(e.g. perforations or translucent regions) in appropriate locations
along the fiber.
[0099] The light emitting unit may include a single light emitter
(of a narrow or broad band of emitted light), or an array of light
emitters generating light of different colors. Also, different
colors can be appropriately mixed and guided to the respective
optical window(s) on the probe member 12. It should also be
understood that with the configuration of FIGS. 3A-3B, a
transparent cover 22 may be used (as shown in FIG. 3B) or may not,
since the entire probe member 12 or respective part thereof with
optical windows 18 can be disposable.
[0100] Reference is made to FIG. 3C schematically showing yet
another example of a probe 200. Probe 200 is configured generally
similar to either one of the herein described examples, namely
including a tampon-like probe member 12 carrying a three
dimensional array of light sources 18, and is further equipped with
an orifice abutment skirt 52 at the distal end 14 of probe member
12. The skirt has a cross-sectional area greater than that of probe
member 12 and extends radially outward from the periphery of probe
member 12 thereby limiting the insertion of probe member 12 into a
body cavity. The skirt (or a part thereof) may be made of a
suitable (e.g. biocompatible) rigid or semi-rigid material so as to
enable support of the probe against the lips of the cavity's
orifice, while radiating the interior of the cavity.
[0101] Reference is made to FIG. 3D illustrating schematically yet
another example of the invention. In this example, a probe device
300 includes a probe member 12 configured to define different
groups (sub-arrays) of light sources (LEDs) producing light
components of different wavelengths, respectively. More
specifically, a three-dimensional array of LEDs 18 is arranged in a
plurality of sub-arrays, generally 18.sub.i, four such sub-arrays
18.sub.1, 18.sub.2, 18.sub.3 and 18.sub.4 being seen in the figure.
For example, LEDs 18.sub.1, 18.sub.2, 18.sub.3 and 18.sub.4 produce
light of, respectively, red, blue, green and yellow colors. It
should be noted that the probe member may carry a series of such
LEDs' groups. The sub-arrays 18.sub.i are arranged one after the
other across the probe member, the LEDs of each sub-array extending
also along the probe member. This configuration allows for rotating
the probe member while in the body cavity to thereby sequentially
subject each region of the inner wall of the body cavity to
different wavelengths of illumination. The illumination of
different wavelengths may for example be carried out with different
illumination conditions, such as pulsed or CW mode, pulse duration
and rate, the entire illumination session duration, etc.
[0102] It should be understood that the probe configuration of the
present invention carrying a three-dimensional array of light
sources may also be advantageously used for skin treatment,
especially when different illumination conditions are to be
successively applied to the skin region. This can be achieved by
rotating (with a predetermined rate) the probe member with respect
to the body tissue to be treated, thus successively bringing the
light source producing light of different color to the treatment
region of the body tissue.
[0103] Reference is made to FIGS. 3E and 3F schematically
illustrating two more examples of the probe member configuration.
In the example of FIG. 3E, a probe device 400 includes a probe
member 12 having a curved (parabolic-like) surface 12A carrying a
three-dimensional array of light sources 18 (LEDs or optical
windows as the case may be), and the opposite substantially planar
surface 12B, on which a handle portion 13 is provided. The light
sources and control unit may be appropriately configured within
and/or outside the probe member as described above. FIG. 3F shows a
probe device 500 including a probe member 12 having a first
plate-like portion 12A thereof of a substantially rectangular
cross-section (e.g. with round edges) carrying light sources 18
arranged in a three-dimensional array within the two opposite
surfaces of portion 12A, and a second cylindrically shaped portion
12A that may serve as a handle portion 13.
[0104] Reference is made to FIG. 3G exemplifying some other
features of the invention. Considering for example the vagina
treatment using a tampon-like probe, the case may be such that a
patient is to undergo a 21-day treatment period. In this case it
would be convenient to provide the patient with a kit, generally at
400, including a set of for example 21 disposable probe devices or
probe members 12 with light sources (light emitters) 18, and
written instructions to use the kit (not shown). Moreover, the case
may be such that a different combination of colors is to be used at
different treatment sessions, thus the light sources combination in
different probe members may be different. For example, a group
G.sub.1 of probes is configured for treatment with a first color or
a first combination of colors, and groups G.sub.2 and G.sub.3 of
probes are intended for second and third color (combinations of
colors) treatments.
[0105] As indicated above, the probe member may be power supplied
from a battery or from a power network. Considering the above
example of FIG. 3G, it might be preferable to use chemiluminescent
light sources rather than those requiring electrical power supply
(LEDs).
[0106] As indicated above, the invention may utilize a pulse mode
of operation of the light emitters, e.g. LEDs. The period of
pulsing, as well as the pulse duration and the entire treatment
duration is selected in accordance with a specific device
application. FIG. 4 exemplifies the configuration of a control unit
30. The latter includes an illumination controller 30C including a
power control utility 30E configured and operable by a processor
utility (software) 30B for appropriately supplying power to the
light emitters (which may be accommodated within the control unit
as exemplified in FIG. 3A or may be carried by the probe member as
exemplified in FIG. 1A) and varying the intensity of emitted light
they produce; a pulse generator unit 30F for setting the frequency
and duration of emitted pulses; a mixer 30G for providing an
appropriate combination of wavelengths (and/or determining their
sequential operation) and power cords and cables to facilitate
operation. It should also be noted that the operational mode may be
such that the same location on the tissue is sequentially
illuminated by different wavelengths, each being applied with a
predetermined operational mode (i.e. pulse or CW and/or duration of
the entire illumination and/or intensity and/or pulse duration and
period) and/or polarization of light.
[0107] Reference is made to FIGS. 5A-5B showing some examples of
how to select the operational parameters of the device for a
specific treatment session. FIG. 5A shows the absorption spectrum
for human fibroblast cells in tissue culture, which may be used for
selection of suitable LED's for use in accordance with the
invention. For example, where high absorption by fibroblast cells
is desired, a wavelength between about 400 nm and about 700 nm,
with fibroblast maximal absorption being in the range of 550-650 nm
wavelength, may be selected. FIG. 5B shows the absorption spectra
of human fibroblasts in a culture along with the wavelengths of
commonly available LED devices, suitable for use in respective
applications of the present invention.
DESCRIPTION OF SOME SPECIFIC EXAMPLES
Example 1
Vaginal Rejuvenation
[0108] In the following example, subjects are treated in accordance
with the invention for restoring the vaginal wall tightness, tone,
elasticity and normal moisture
[0109] Subjects selected for treatment (inclusion criteria) are
healthy parous females complaining of one or more of the following
symptoms: loosed vagina; sexual dysfunction; excessive odorous
discharge; male partner dissatisfaction; embarrassment; emotional
distress.
[0110] Subjects are treated by exposure of the vagina to light
(RGB) according to the following treatment schedule (Table 1):
TABLE-US-00001 TABLE 1 Schedule of treatment ##STR00001## 1 2 3 4 5
6 7 1 R R R G Y Y R 2 R R R G R R G 3 Y Y Y Y R Y Y where R = Red;
G = Green; Y = Yellow.
[0111] Recommended treatment continues for a period of three months
and includes daily exposure of the vagina to light for 10 minutes.
During the period, treatment is ceased (thus, during a month there
21 consecutive days of treatment).
[0112] Results are assessed during treatment based on a
questionnaire filled by the treated subject comparing the severity
of complains before during and after the treatment.
Example 2
Bacterial Vaginosis
[0113] Vaginitis (infection of the vagina) is a common gynecologic
problem. The most common causes of vaginitis are Trichomonas
vaginalis infection, vaginal candidiasis, and bacterial vaginosis
(BV). In the following example subjects are treated in accordance
with the invention against bacterial vaginosis in order to restore
the normal bacteria flora.
[0114] Subjects selected for treatment (inclusion criteria) are
females complaining of abnormal or odorous vaginal discharge and
pruritus attributed to vaginosis or diagnosed as such by a positive
vaginal swab culture.
[0115] Subjects are treated for a period of 1 week by exposure of
the vagina to light (RGB) according to the following treatment
schedule (Table 2):
TABLE-US-00002 TABLE 2 Schedule of treatment ##STR00002## 1 2 3 4 5
6 7 1 B B B B R R B 2 B B R R R B B 3 R R B B R B B where R = Red;
B = Blue.
[0116] Treatment includes three daily exposures of the vagina, as
specified in Table 2, each exposure lasts for 7 minutes, for a
total period of 1 week.
[0117] Results are exhibited by the restoration of normal vaginal
flora and/or relief of symptoms or by obtaining a normal vaginal
swab culture.
Example 3
Hemorrhoids
[0118] Subjects suffering from internal and/or external hemorrhoids
are treated by exposure of the hemorrhoids to light in order to
reduce hemorrhoid volume and to prevent hemorrhoid inflammation and
pain resulting therefrom.
[0119] Subjects selected are those which complain about bleeding,
pain or discomfort.
[0120] Subjects are treated for a period of 2 weeks by exposure of
the hemorrhoids to light (RGB) according to the following treatment
schedule (Table 3):
TABLE-US-00003 TABLE 3 Schedule of treatment ##STR00003## 1 2 3 4 5
6 7 1 G G R R G R Y 2 G R R R G Y Y where R = Red; G = Green; Y =
Yellow.
[0121] Treatment includes a daily exposure of the hemorrhoids, as
specified in Table 3, each exposure lasts for 10 minutes, for a
total period of 2 weeks or more, according to the condition.
[0122] Improvement or efficacy of treatment is exhibited by
regression of symptoms associated with hemorrhoid and regression of
bleeding.
Example 4
Lacrimal Duct Occlusion
[0123] Subjects exhibiting lacrimal duct occlusion (abnormally
increased tearing) are selected for this treatment. Treatment is
executed by the use of an optical fiber adjacent to the lacrimal
duct so as to expose the interior thereof to light (RGB) using red
light after covering the eye (in order to prevent exposure of the
eye) three treatments per week, lasting 4 minutes each.
[0124] Results are determined by reduced tearing and
inflammation.
Example 5
Intranasal Treatment
[0125] Intranasal administration of drugs has become in the past
years a selected route of administration of several drugs, for
systemic delivery. Blood levels of the administered drug may be
elevated by pre-treating the intranasal cavity by increase in drug
absorption at that site. Drug absorption may be increase by
radiation of the inner walls of the nostrils by light. The
following example makes use of red light, although other
wavelengths and optical energy may be applicable as well. Subjects
selected for treatment are those in which there is interest in
reducing nasal mucosa congestion, (hey fever, allergy) or suffering
of intranasal polyps, or prior to a scheduled nasal administration
of drugs (such as special fertility drugs).
[0126] Subjects are treated by exposure of the intranasal cavity to
red light for 5 minutes prior to or 3 minutes prior and 3 min
immediately after administration of the drug to the treated
cavity.
[0127] Treatment efficacy is exhibited by increased blood levels of
the drug and improved drug efficacy as compared to treatment
without radiation (control group).
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