U.S. patent application number 16/999420 was filed with the patent office on 2020-12-10 for device for treating the vaginal canal or other natural or surgically obtained orifices, and related apparatus.
The applicant listed for this patent is EL.EN. S.P.A.. Invention is credited to Mauro GALLI, Leonardo MASOTTI, Stefano MODI, Maurizio SCORTECCI.
Application Number | 20200384284 16/999420 |
Document ID | / |
Family ID | 1000005034422 |
Filed Date | 2020-12-10 |
![](/patent/app/20200384284/US20200384284A1-20201210-D00000.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00001.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00002.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00003.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00004.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00005.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00006.png)
![](/patent/app/20200384284/US20200384284A1-20201210-D00007.png)
United States Patent
Application |
20200384284 |
Kind Code |
A1 |
MASOTTI; Leonardo ; et
al. |
December 10, 2020 |
DEVICE FOR TREATING THE VAGINAL CANAL OR OTHER NATURAL OR
SURGICALLY OBTAINED ORIFICES, AND RELATED APPARATUS
Abstract
A device for treating the vaginal canal by a laser beam. The
device for treating the vaginal canal includes a retractor for the
wall of the vaginal canal, associated with a scanning system for
scanning the laser beam towards the wall by means of a pyramidal
mirror for laser beam reflection.
Inventors: |
MASOTTI; Leonardo; (Sesto
Fiorentino (FI), IT) ; GALLI; Mauro; (Sesto
Fiorentino (FI), IT) ; MODI; Stefano; (Borgo San
Lorenzo (FI), IT) ; SCORTECCI; Maurizio; (Prato,
IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
EL.EN. S.P.A. |
Calenzano(FI) |
|
IT |
|
|
Family ID: |
1000005034422 |
Appl. No.: |
16/999420 |
Filed: |
August 21, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14909250 |
Feb 1, 2016 |
10786682 |
|
|
PCT/EP2014/066211 |
Jul 28, 2014 |
|
|
|
16999420 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00994
20130101; A61B 2090/3618 20160201; A61B 18/1485 20130101; A61N
2005/0659 20130101; A61B 2090/036 20160201; A61B 1/303 20130101;
A61B 2018/00559 20130101; A61B 90/361 20160201; A61B 17/3494
20130101; A61B 2017/345 20130101; A61N 2005/0611 20130101; A61B
17/3421 20130101; A61N 1/40 20130101; A61N 2005/0666 20130101; A61N
2005/067 20130101; A61N 5/0603 20130101 |
International
Class: |
A61N 5/06 20060101
A61N005/06; A61B 18/14 20060101 A61B018/14; A61B 1/303 20060101
A61B001/303; A61B 90/00 20060101 A61B090/00; A61B 17/34 20060101
A61B017/34; A61N 1/40 20060101 A61N001/40 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 1, 2013 |
IT |
FI2013A000182 |
Oct 22, 2013 |
IT |
FI2013A000252 |
Claims
1. A device for treating a vaginal canal or other natural or
surgically obtained orifices by means of a laser beam, the device
comprising: a retractor for a wall of said canal or orifice
associated with a laser beam scanning system, wherein: said
retractor comprises a pyramidal or truncated pyramidal laser beam
reflection mirror, which is provided with a plurality of planar
reflecting surfaces arranged around a retractor axis and inclined
with respect thereto, and is located near a retractor distal end;
the laser beam scanning system is configured and controlled to
direct the laser beam sequentially towards each planar reflecting
surface of the laser beam reflection mirror, a series of laser
spots according to an irradiation treatment pattern being generated
on each reflecting surface and being reflected thereby outside the
retractor.
2. A device according to claim 1, wherein: said retractor has a
substantially cylindrical hollow body, at a distal end whereof said
laser beam reflection mirror is fixed; and said laser beam
reflection mirror is connected to said substantially cylindrical
hollow body of the retractor by means of at least one spacer
leaving a free space between the laser beam reflection mirror and
the substantially cylindrical body of the retractor, said at least
one spacer being arranged at a corner of the laser beam reflection
mirror.
3. A device according to claim 1, wherein said retractor comprises
an image acquisition system for acquiring images of walls of the
vaginal canal or other orifices, associated with said
retractor.
4. A device according to claim 3, wherein an image acquisition
mirror is associated with said laser beam reflection mirror.
5. A device according to claim 4, wherein said image acquisition
mirror has a conical or truncated-conical reflecting surface.
6. A device according to claim 4, wherein the laser beam reflection
mirror and the image acquisition minor are substantially
coaxial.
7. A device according to claim 6, wherein said laser beam
reflection mirror and said image acquisition mirror are directed
with respect to each other so that a lighting beam reflected by the
laser beam reflection minor illuminates a portion of the canal or
orifice of which the image acquisition mirror reflects the image
towards an image acquisition lens.
8. A device according to claim 1, wherein said laser beam
reflection minor has quadrangular and preferably square base.
9. A device according to claim 5, wherein the image acquisition
mirror and the laser beam reflection minor are substantially
coaxial, with vertexes or smaller bases facing each other.
10. A device according to claim 3, wherein said image acquisition
system comprises a camera housed in the laser beam reflection
mirror.
11. A device according to claim 1, wherein said retractor has a
substantially cylindrical hollow body, at a distal end whereof said
laser beam reflection mirror is fixed.
12. A device according to claim 11, wherein an aperture is defined
between the distal end of the substantially cylindrical hollow body
and the laser beam reflection mirror, and through said aperture a
free path extends for the laser beam reflected by the laser beam
reflection mirror towards the wall of the canal or orifice in which
the device is inserted.
13. A device according to claim 11, wherein at a proximal end of
the substantially cylindrical hollow body an element is provided
for coupling the retractor to a support containing the laser
scanning system.
14. A device according to claim 11, wherein said laser beam
reflection mirror is connected to a substantially cylindrical body
of the retractor by means of one or more spacers leaving a free
space between the laser beam reflection mirror and the
substantially cylindrical body of the retractor.
15. A device according to claim 14, wherein said spacers are
arranged at corners of the laser beam reflection mirror.
16. A device according to claim 1, further comprising: a stop
cooperating with the retractor to control a depth to which the
retractor is inserted into the canal or orifice and said stop and
said retractor are preferably movable with respect to each other
along an axial extension of the retractor.
17. A device according to claim 16, wherein said retractor has
indicia for positioning the stop.
18. A device according to claim 1, wherein at least one electrode
is arranged along the retractor and can be associated with a
radio-frequency current source.
19. A device according to claim 11, wherein at least one electrode
is arranged along the retractor and can be associated with a
radio-frequency current source, wherein said electrode extends
along the substantially cylindrical hollow body of the retractor
and emerge on an outer surface of the substantially cylindrical
hollow body.
20. A device according to claim 1, further comprising a wireless
system for transmitting images from the device to an image
processing apparatus.
21. A device according to claim 2, wherein said retractor comprises
an image acquisition system for acquiring images of walls of the
vaginal canal or other orifices, associated with said
retractor.
22. A device according to claim 5, wherein the laser beam
reflection mirror and the image acquisition minor are substantially
coaxial.
23. A device according to claim 22, wherein said laser beam
reflection mirror and said image acquisition mirror are directed
with respect to each other so that a lighting beam reflected by the
laser beam reflection minor illuminates a portion of the canal or
orifice of which the image acquisition mirror reflects the image
towards an image acquisition lens.
24. A device according to claim 11, wherein two electrodes are
arranged along the retractor and can be associated with a
radio-frequency current source, wherein said two electrodes extend
along the substantially cylindrical hollow body of the retractor
and emerge on an outer surface of the substantially cylindrical
hollow body.
25. A device according to claim 24, wherein the two electrodes are
parallel to one another.
26. A laser apparatus comprising a laser source, a waveguide and a
device connected with said laser source through said waveguide,
said device comprising a retractor for a wall of a canal or orifice
associated with a laser beam scanning system, wherein said
retractor comprises a pyramidal or truncated pyramidal laser beam
reflection mirror, which is provided with a plurality of planar
reflecting surfaces arranged around a retractor axis and inclined
with respect thereto, and is located near a retractor distal end,
the laser beam scanning system being configured and controlled to
direct the laser beam sequentially towards each planar reflecting
surface of the laser beam reflection mirror, a series of laser
spots according to an irradiation treatment pattern being generated
on each reflecting surface and being reflected thereby outside the
retractor.
27. A laser apparatus according to claim 26, wherein said laser
source is a pulsed laser source.
28. A laser apparatus according to claim 26, wherein said laser
source is a continuous laser source.
29. A laser apparatus according to claim 28, wherein the pulses
have a duration between about 0.1 and about 10 ms.
30. A laser apparatus according to claim 26, wherein a wavelength
of said laser source is between about 1000 nm and about 12,000
nm.
31. A laser apparatus according to claim 26, wherein said laser
source has a power between about 2 and about 100 W.
32. A laser apparatus according to claim 26, wherein said source
and said device are controlled so as to generate a pulsed treatment
pattern, wherein a space between subsequent scanning points is
between 0 and about 5,000 micrometers.
33. A laser apparatus according to claim 27, wherein a pulsed or
continuous laser beam is controlled to remain on the same points
repeating an emission duration up to 5 times a duration of a single
emission.
34. A laser apparatus according to claim 27, further comprising an
image receiving system for receiving images from said device.
35. A laser apparatus according to claim 34, wherein said image
receiving system is a wireless system.
36. A laser apparatus according to claim 26, further comprising an
image processing system to reduce or eliminate distortion of images
collected by means of a curve mirror, in particular a conical or
truncated conical minor.
37. A laser apparatus according to claim 27, wherein the pulses
have a duration between about 0.2 and about 2 ms.
38. A laser apparatus according to claim 26, wherein a wavelength
of said laser source is 10,600 nm.
39. A laser apparatus according to claim 38, wherein said laser
source is a CO.sub.2 laser source.
40. A laser apparatus according to claim 26, wherein said laser
source has a power between 10 and about 50 W.
41. A laser apparatus according to claim 26, wherein said laser
source has a power between about 30 and about 50 W.
42. A laser apparatus according to claim 26, wherein said source
and said device are controlled so as to generate a pulsed treatment
pattern, wherein a space between subsequent scanning points is
between about 50 and about 5,000 micrometers.
43. A laser apparatus according to claim 26, wherein said source
and said device are controlled so as to generate a pulsed treatment
pattern, wherein a space between subsequent scanning points is
between about 200 and about 2,000 micrometers.
44. A laser apparatus for treating mucosa of a vaginal canal,
comprising: a pulsed laser source having a wavelength between about
1000 nm and about 12,000 nm; a device for treating the vaginal
canal, comprising a retractor for a wall of the vaginal canal and a
laser beam scanning system associated with said retractor; a
waveguide for conveying a laser beam towards said device, wherein
said retractor comprises a pyramidal or truncated pyramidal laser
beam reflection mirror, which is provided with a plurality of
planar reflecting surfaces arranged around a retractor axis and
inclined with respect thereto, and is located near a retractor
distal end, wherein the laser beam scanning system is configured
and controlled to direct the laser beam sequentially towards each
planar reflecting surface of the laser beam reflection mirror, a
series of laser spots according to an irradiation pattern being
generated on each reflecting surface and being reflected thereby
outside the retractor.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation under 37 CFR 1.53(b) of
pending prior U.S. patent application Ser. No. 14/909,250 filed
Feb. 1, 2016 and claims the benefit (35 U.S.C. .sctn. 120 and
365(c)) of International Application PCT/IB2014/066211 filed Jul.
28, 2014, which designated inter alia the United States and which
claims the priority of Italian Patent Application FI2013A000182
filed Aug. 1, 2013 and Italian Patent Application FI2013A000252
filed Oct. 22, 2013, the entire contents of each application are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of
electro-medical machines and more in particular to the field of
machines and apparatuses using a laser source for treating human
body.
BACKGROUND OF THE INVENTION
[0003] Various applications of laser radiation are well known for
surgical, aesthetic or therapeutic treatment of human body. In some
applications, laser is used instead of surgical knife as cutting
tool. In other applications, laser is used to necrotize tumor
tissues, to bio-stimulate the growth of particular tissues, for
instance cartilaginous tissue for pain treatment and collagen
tissue for aesthetic purposes, for instance for wrinkle reduction,
rejuvenation, scalp treatment for hair growth purposes, etc.
[0004] WO-A-2011096006 discloses a device for treating vaginal
canal by a laser beam. The device comprises a vaginal canal wall
retractor, associated to a system for directing the laser beam
towards the wall. This allows using the laser beam for treating the
mucosa of the vaginal canal. The main purpose of the treatment
disclosed in WO-A-2011096006 is to prevent and treat atrophic
vaginitis, a condition typical but not exclusive of the
post-menopause period that currently is normally treated with
oestrogens for short periods. Atrophic vaginitis is a pathological
condition characterized by an inflammation of the vaginal mucosa
with progressive decrease of the mucosa thickness due to the loss
of collagen structure. Atrophic vaginitis is a highly disabling
condition responsible for considerable psychological discomfort for
women suffering from this condition, due to the associated pain,
burn, bleeding, ectropion and due to the impossibility of having
normal sexual intercourse (dyspareunia).
[0005] The device disclosed in WO-A-2011096006 represents an
improvement over the state of the art, but can still be further
improved to ameliorate the efficiency thereof and make its use
simpler and more comfortable for the patient.
[0006] EP-A-2476460 discloses a laser system for non-ablative
treatment of mucosa tissue. In one embodiment, the system comprises
a retractor containing a planar mirror. The planar mirror reflects
an impinging laser beam sideways towards the wall of a cavity being
treated. The laser beam is controlled to be moved according to a
treatment pattern. In another embodiment disclosed in EP-A-2476460,
the device comprises a conical mirror. The laser beam is directed
coaxially against the conical surface of the conical mirror, which
defocusses the laser beam and reflects it over 360.degree. all
around the axis of the conical mirror, thus providing a
circumferential irradiation of a cylindrical irradiation area on a
target area surrounding the retractor wherein the conical mirror is
arranged. The shape of the conical mirror de-focusses the laser
beam thus reducing the effectiveness thereof on the surrounding
tissue.
SUMMARY OF THE INVENTION
[0007] According to a first aspect, the invention substantially
provides a device for laser treatment of the vaginal canal in
particular and in general of both natural and surgically obtained
orifices, of the animal or human body. The device comprises a
retractor for the wall of the vaginal canal or other orifice
associated with a system for scanning a laser beam towards the wall
of the cavity, canal or orifice. The device advantageously
comprises a laser beam reflection mirror, which is preferably
pyramidal or truncated pyramidal and preferably fixed with respect
to the retractor. The laser beam reflection mirror can be located
near a distal end of the retractor. More in general, the laser beam
reflection mirror is provided with a plurality of flat, i.e. planar
reflecting surfaces, formed by the planar side surfaces of the
pyramidal laser beam reflection mirror. The planar reflecting
surfaces are inclined with respect to the retractor axis to deviate
the laser beam directed by a laser scanning system towards the
planar reflecting surfaces of the laser beam reflection mirror. The
inclined planar reflecting surfaces deviate the laser beam towards
the outside, i.e. against the tissue of the cavity or canal under
treatment wherein the retractor has been inserted. The laser beam
is deviated in a direction preferably approximately orthogonal to
the retractor axis. As it will be clearly apparent from the
description below of some embodiments, the pyramidal,
truncated-pyramidal allows to treat a surface extending for a given
angle, also for 360.degree. around the retractor axis, by moving
the laser beam controlled by the laser scanning system, without the
need for the retractor to be rotated. In this way the treatment is
easier to be performed and more comfortable for the patient.
[0008] From an optical viewpoint the use of a pyramidal laser beam
reflection mirror instead of a conical mirror is particularly
advantageous. The planar reflecting surfaces reflect a focused
laser beam directed against the surfaces by the laser scanning
system. The reflected laser beam remains focused and is thus
particularly efficient in treating the tissue of the canal or
cavity being treated with the device. The shape of the laser spot
(i.e. the cross sectional form and energy distribution) remains
substantially equal after reflection by the planar reflecting
surface of the pyramidal or truncated pyramidal laser reflection
mirror. It is thus possible to control the laser beam by means of
the laser scanning system, such that the laser beam is moved
according to a pre-determined pattern on the reflecting surfaces
and thus on the targeted tissue surface. A fractional treatment of
the tissue forming the wall of the canal or cavity under treatment
becomes possible, with an accurate control of the laser irradiation
parameters in each irradiated spot.
[0009] The use of a plurality of planar reflecting surfaces
arranged according to a pyramidal or truncated pyramidal
arrangement is particularly advantageous since the laser beam can
be moved sequentially on each one of the reflecting surfaces, thus
treating the entire surrounding tissue around 360.degree. without
rotating the retractor around its axis. The treatment becomes
easier for the operator, quicker and causes less discomfort for the
patient.
[0010] The laser beam is controlled so as to move according to a
pattern on each reflecting planar surface of the laser reflection
mirror and moves from one reflecting surface to the other very
quickly, so that treatment of each circumferentially extending
tissue portion becomes fast and does not require but one rotation,
if any, of the retractor inside the canal or cavity under
treatment.
[0011] As will become apparent from the following description of
exemplary embodiments of the invention, the laser spot can be moved
according to a pattern on each planar reflecting surface until the
pattern is completed and then moves on the next reflecting surface,
repeating thereon the required pattern. In other embodiments, the
laser beam can be moved sequentially onto the various reflecting
surfaces more than once, each time performing a part of the pattern
on each reflecting surface.
[0012] The retractor advantageously has an open window extending
for about 360.degree. around the retractor axis, substantially in
correspondence of the reflecting surface or surfaces of the
pyramidal laser beam reflection mirror. Open window means a window
devoid of closing materials, so that the laser beam, deviated by
the reflecting surfaces of the pyramidal or truncated pyramidal
laser beam reflection mirror, impinges against the wall of the
cavity, canal or orifice, this wall being usually formed by tissues
that in this way directly face the laser beam reflection mirror,
without foreign material interposed between the reflecting surface
or surfaces and the tissue. In this way, the laser beam does not
need to pass through a window made of any material. It is therefore
not necessary to select materials for closing the window that are
transparent to the useful wavelength of the laser beam. In fact, it
could be possible that these materials are not compatible with the
medical use because they are toxic or not suitable for the contact
with the patient's tissues.
[0013] In an improved embodiment, the retractor comprises an image
acquiring device for acquiring images of the treated canal or
orifice. This image acquisition system may comprise an image
acquisition mirror. In some embodiments the image acquisition
mirror is conical, i.e. it has a conical reflecting surface, and is
preferably coaxial with the pyramidal or truncated-pyramidal laser
beam reflection mirror reflecting the laser beam. Inside the laser
beam reflection mirror a camera or a micro-camera may be arranged,
acquiring images reflected by the image acquisition mirror.
Furthermore, also a lighting system may be housed inside the
pyramidal or truncated-pyramidal laser beam reflection mirror
reflecting the laser beam. In other embodiments lighting can be
obtained by means of a light source arranged at a distance from the
laser beam reflection mirrors and generating a lighting beam
reflected towards the pyramidal or truncated-pyramidal laser beam
reflection mirror by means of the laser beam scanning mirrors.
[0014] According to a further improved embodiment of the invention,
the retractor may be provided with electrodes for radio-frequency
treatment of the tissues. The electrodes may have a linear
extension, be preferably parallel to one another and preferably
parallel to the retractor axis.
[0015] Further advantageous features and embodiments are described
below and in the attached claims, forming an integral part of the
present description.
[0016] According to a further aspect, the invention relates to a
laser apparatus comprising a laser source, a waveguide and a device
as described above. The laser beam generated by the laser source is
conveyed by means of the waveguide towards the device. The scanning
system, e.g. a pair of scanning mirrors, arranged in the device
control the movement of the laser beam along the planar reflecting
surfaces of the pyramidal or truncated pyramidal laser reflection
mirror.
[0017] In this context, waveguide means any system suitable for
conveying the laser beam from the source to the applying device.
The waveguide may be constituted by an optical fiber system. In
other embodiments, the waveguide may comprise hollow tubular
elements, inside which the laser beam is directed, by means of
suitable deviating mirrors arranged for instance in joints between
consecutive tubular elements and movable with respect to one
another.
[0018] In some advantageous embodiments the laser source is a
pulsed source, wherein the pulses have for instance a duration
between about 0.1 and about 10 milliseconds, preferably between
about 0.2 and about 2 milliseconds, or a continuous source having
emission times comprised between 0.5 and 50 milliseconds. The laser
radiation may have a wavelength comprised for instance between
about 1,000 nm and about 12,000 nm, preferably between about 9,400
and about 10,600 nm and typically equal to 10,600 nm.
[0019] The power of the beam emitted by the source is chosen so
that the beam has on the mucosa the effect of renewing the
epithelium and stimulating the collagen production, as mentioned
above. Typically, the power can be comprised between about 2 and
about 100 W, preferably between about 10 and about 50 W and more
preferably between about 30 and about 50 W.
[0020] The apparatus may comprise systems for controlling the
scanning mirrors so as to move the pulsed or continuous beam to
perform a treatment according to a method providing for investing
the mucosa with laser pulses in areas or points adjacent to each
other and consecutive along a preset path, wherein the space
between scanning points may be preferably comprised between 0 and
about 5,000 micrometers, and preferably between about 50 and about
5,000 micrometers and more preferably between about 200 and about
2,000 micrometers. The pulses for each point may be single or
multiple. From one to four pulses for each point may be
provided.
[0021] The present invention will be described in detail below with
reference to the attached figures. The various features of novelty
which characterize the invention are pointed out with particularity
in the claims annexed to and forming a part of this disclosure. For
a better understanding of the invention, its operating advantages
and specific objects attained by its uses, reference is made to the
accompanying drawings and descriptive matter in which preferred
embodiments of the invention are illustrated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] In the drawings:
[0023] FIG. 1 is a schematic view of the apparatus in one
embodiment;
[0024] FIG. 2 is a schematic view of the end part of the
articulated arm of the apparatus of FIG. 1, the scanning system and
the retractor;
[0025] FIG. 3 is a side view of the retractor, separated from the
remaining part of the apparatus;
[0026] FIG. 4 is a view according to IV-IV of FIG. 3;
[0027] FIG. 5 is a sectional view according to V-V in FIG. 3;
[0028] FIG. 6 is a cross-sectional view according to VI-VI of FIG.
3;
[0029] FIG. 7 is a cross-sectional view according to VII-VII of
FIG. 3;
[0030] FIG. 8 is an axonometric view of the retractor;
[0031] FIG. 9 is a schematic view for fractional treatment of the
vaginal tissue;
[0032] FIG. 10A is a view of a path of the laser radiation spot on
the reflecting surfaces of the pyramidal laser beam reflection
mirror in a possible use of the device;
[0033] FIG. 10B is a view of a path of the laser radiation spot on
the reflecting surfaces of the pyramidal laser beam reflection
mirror in a possible use of the device;
[0034] FIG. 10C is a view of a path of the laser radiation spot on
the reflecting surfaces of the pyramidal laser beam reflection
mirror in possible uses of the device;
[0035] FIG. 11 is a view of a functional block diagram of a system
comprising a retractor with an image acquisition camera and an
image processing unit;
[0036] FIG. 12 is a schematic sectional view of a pyramidal laser
beam reflection mirror with an integrated image acquisition camera
and an image acquisition mirror to be used with a retractor of the
type described herein;
[0037] FIG. 13 is a side view of a retractor equipped with a laser
beam reflection mirror and image acquisition mirror according to
FIG. 12;
[0038] FIG. 14 is a side view of a retractor with an integrated
electrode system for radio-frequency treatment; and
[0039] FIG. 15 is a local sectional view according to XV-XV of FIG.
14.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] Referring to the drawings, FIG. 1 shows a schematic of an
apparatus according to the invention. The apparatus, indicated as a
whole with number 1, has a support 3 provided for instance with
wheels 5 so as to be moved on the floor. A laser source 7 is
located on the support 3; the laser source is connected, by means
of a waveguide 9, with a treatment device 11. In some embodiments
the waveguide 9 is formed by tubular segments 9A joined together by
means of known articulated elements 9B to allow the device 11 to be
positioned and moved. In the articulated elements scanning mirrors
may be provided for directing the laser beam along consecutive
tubular segments. The device 11 is at the terminal end of the
waveguide.
[0041] The device 11 is shown in detail in FIG. 2. It comprises a
box-shaped body forming a housing 13, inside which a laser scanning
system is arranged. According to some embodiments, the laser
scanning system can comprise scanning mirrors. Two scanning mirrors
13A and 13B are schematically shown with broken lines in the
illustrated example. The movement of the scanning mirrors around
their axes of rotation is controlled by respective actuators, for
instance galvanometers, under the control of a central unit 14,
arranged for instance on the support 3 and connected to the device
11 via a cable 15. The control unit 14 is also connected to the
laser source 7 to control the emission thereof. Buttons, capacitive
sensors or other interface elements may be provide on the
box-shaped body forming the housing 13, allowing the user to handle
the apparatus and to control the laser emission.
[0042] A retractor indicated as a whole with reference number 19 is
associated with the housing 13 of the device 11. This retractor can
be advantageously reversibly applied to the housing 13, so that it
is possible to use retractors 19 differing in shape and dimension
and/or to allow sterilization, or else the use of disposable
retractors 19 for hygiene and asepsis reasons.
[0043] The retractor 19 of the treatment device 11 is shown in
detail in FIGS. 3-8.
[0044] In some embodiments the retractor 19 has at its distal end
anchoring members for fixing it to the housing 13, wherein the
scanning mirrors 13A and 13B are located. In the illustrated
embodiment the retractor 19 has a bayonet coupling schematically
indicated with 21. In other embodiments a different coupling may be
provided, for instance a screw coupling. The bayonet coupling has
however specific advantages in terms of quickness in coupling and
releasing, as well as of easiness in cleaning the retractor 19
after use, as the bayonet coupling 21 does not have areas forming
receptacles for microorganisms.
[0045] The retractor 19 may have a substantially cylindrical hollow
body 23, as shown in particular in the section of FIG. 5. At the
opposite end with respect to the bayonet coupling 21 the hollow
body 23 of the retractor 19 carries a laser beam reflection mirror,
indicated as a whole with reference number 25. The laser beam
reflection mirror 25 can be pyramidal or truncated pyramidal and be
provided with a plurality of reflecting surfaces 25A. The
reflecting surfaces 25A are preferably planar. In some exemplary
embodiments four reflecting surfaces 25A can be provided on the
laser beam reflection mirror 25. In other embodiments three, five,
six, seven, eight or more reflecting surfaces 25A can be
provided.
[0046] The laser beam reflection mirror 25 may be fixed to the
tubular body 23 of the retractor 19, for instance by means of bars
27. In the illustrated embodiment the laser beam reflection mirror
25 and the tubular hollow body 23 are connected together by means
of two diametrically opposite bars 27. The bars 27 form spacers
supporting the laser beam reflection mirror 25 at a sufficient
distance from the end edge of the retractor 19, to form a nearly
annular window or slit, where through the laser beam passes. The
annular slit or opening formed between the end edge, indicated with
23B, of the tubular hollow body 23 and the base, indicated with
25B, of the pyramidal laser beam reflection mirror 25, is
preferably completely open, so that the laser beam, deviated by
means of the reflecting surfaces 25A of the pyramidal laser beam
reflection mirror 25, propagates in air up to the surface of the
surrounding tissue of the vaginal canal in which the retractor 19
is inserted. This allows the application of laser sources with a
wavelength that could not pass through closing walls.
[0047] For treating the dysfunctions of the vaginal tissue
mentioned in the introductory part of the specification, the
CO.sub.2 laser has been proved to be particularly useful; to its
wavelength only toxic materials, such as zinc selenide, are
transparent, that are therefore incompatible with this use. It is
therefore particularly advantageous to have a free path, i.e. a
path in air, for the radiation reflected by the reflecting surfaces
25A of the laser beam reflection mirror 25 to treat the wall of the
vaginal canal by means of CO.sub.2 laser.
[0048] In other embodiments it is also possible to provide a window
closed by means of a material transparent to the wavelength of the
laser used, in case there are available non toxic materials
transparent to the wavelength used. For instance, in the case of
treatment with light in or near the visible spectrum, transparent
plastics may be used to form walls, where through the path of the
reflected laser beam extends. In this case, instead of spacing bars
27, an annular element may be used, made of a material transparent
to the laser radiation, interposed between the distal edge 23B of
the cylindrical body 23 of the retractor 19 and the base 25B of the
laser beam reflection mirror 25.
[0049] In advantageous embodiments the mirror 25 is shaped like a
pyramid with a regular polygonal base, for instance and preferably
with a square base. In other embodiments, not shown, the laser beam
reflection mirror 25 may be shaped like a truncated pyramid, also
in this case with preferably a regular polygonal base, preferably a
square base. It is also possible to use mirrors shaped like a
pyramid or a truncated pyramid with different bases, for instance a
triangular, a pentagonal or a hexagonal base. The square shape of
the base of the pyramid forming the mirror 25 is particularly
advantageous and is currently preferred.
[0050] In the illustrated embodiment, the pyramidal laser beam
reflection mirror 25 with square base has four reflecting surfaces
indicated with 25A and formed on the side faces of the pyramid. The
two bars 27 are advantageously arranged in correspondence of two
corners of the square base of the laser beam reflection mirror 25
and are therefore arranged substantially on a plane where two of
the four corners of the pyramid forming the laser beam reflection
mirror 25 are located.
[0051] With the above described arrangement of the reflecting
surfaces 25A the movement of the scanning mirrors 13A, 13B allows
to perform a particularly comfortable treatment of the tissue of
the vaginal canal inside which the device 11 is inserted. In fact,
it is sufficient to move the device 11 only in the longitudinal
direction, i.e. parallel to its own axis, for instance moving this
device 11 gradually towards the outside after having inserted it
completely inside the vaginal canal. Thanks to the movement of the
scanning mirrors 13A, 13B controlled by respective galvanometers
(known and not shown) the laser beam generated by the laser source
is directed from the reflecting surfaces 25A of the laser beam
reflection mirror 25 on all the circumferential extension of a
given section of the vaginal canal, in correspondence of which the
laser beam reflection mirror 25 is positioned each time by means of
the longitudinal movement according to incremental steps, for
instance guided by means of visible marks provided on the retractor
portion visible to the operator. On the contrary of what occurs
with other known systems, for instance the system described in
WO20110960006, it is not necessary to rotate the device 11 inside
the vaginal canal, thus making the use of the apparatus easier for
the operator and less invasive for the patient. As it will be
specified below, in some cases the retractor 19 shall be rotated
only once to have a more uniform treatment.
[0052] The tissue of the vaginal canal may be irradiated for
instance by displacing the laser beam by means of the controlled
movement of the scanning mirrors 13A, 13B on each of the four
planar reflecting surfaces 25A of the mirror 25 sequentially. On
each reflecting surface 25A the laser beam can be moved in a
direction parallel to the corresponding base edge of the pyramid
forming the laser beam reflection mirror 25 and gradually from the
base towards the vertex or vice versa, so that the laser beam
reflected by the reflecting surface 25A involves a
non-infinitesimal portion of tissue. The laser beam can be then
sequentially moved on the remaining three faces of the pyramid to
work on each of them. This functioning method is schematically
represented in FIG. 10A, showing, similar to FIG. 6, a front view
of the pyramidal laser beam reflection mirror. The laser beam is
controlled by means of the scanning mirrors so as to form a spot
moving parallel to the base edge of one of the four faces of the
pyramid. In a first phase the laser beam is moved parallel to the
base edge and adjacent to it so as to produce a series of spots S1.
The laser beam may be actuated in an intermittent pulsed way each
time the scanning mirrors 13A, 13B have been positioned to direct
the beam in correspondence of one of the spots S1. In
correspondence of each spot S1 the beam is deviated, approximately
orthogonally to the axis of the retractor 19, towards the side
surface of the vaginal canal and nearly orthogonally thereto. Once
the row of spots S1 has been completed, the laser beam is moved by
means of the scanning mirrors 13A, 13B to form a second row of
spots S2, at a greater distance from the base edge, and so on,
gradually moving towards the vertex of the pyramid forming the
laser beam reflection mirror 25. Practically, some lines of spots
S1, S2 will be followed, involving a portion of the reflecting
surface 25A near the base. Then, the laser beam is moved on the
adjacent surface 25A to repeat the process, generating a series of
spots on the reflecting surface and, thus, on the tissue of the
vaginal canal. The process is repeated on all four faces. As it
will be explained below, to avoid non-uniformity due to the edges
of the pyramid and the bars 27, the whole process may be repeated
rotating the retractor 19, and therefore the pyramidal laser beam
reflection mirror 25, by a suitable angle, for instance
45.degree..
[0053] In other embodiments the laser beam may be moved in a
substantially circular manner to be reflected in sequence by each
of the four faces of the pyramidal laser beam reflection mirror 25
and moving gradually the laser beam so as to displace, at each
revolution thereof around the axis of the pyramidal or truncated
pyramidal laser beam reflection mirror, the reflection point of the
beam from the base of the pyramid towards the vertex or vice versa,
so as to invest an area of sufficient axial dimension of the tissue
forming the vaginal canal. This operative mode is illustrated in
FIGS. 10B and 10C. In FIG. 10B the first series of spots S1 is
illustrated, created by moving the laser beam along the four base
edges of the pyramidal laser beam reflection mirror. Once the
closed path around the pyramid base has been completed, the beam is
moved towards the vertex and along a closed path, forming the spots
S2. In FIG. 10C the first phase is shown of this second movement of
the beam with the formation of the spots on one of the four
reflecting surfaces 25A of the laser beam reflection mirror 25. The
process is repeated for a certain number of increasingly reducing
closed paths while moving towards the vertex. Due to the effect of
the laser beam reflection by means of the reflecting surfaces 25A,
spots are therefore generated on the surface of the tissue of the
vaginal canal, arranged according to substantially circular
trajectories. In this case again, for each axial portion of the
retractor 19 in the vaginal canal it is possible to perform the
irradiation process twice, rotating the retractor 19 by an angle,
for instance by 45.degree., between one process and the other, to
avoid non-uniformity in the treatment.
[0054] In other embodiments the laser beam may be controlled to
make a single revolution around the axis of the pyramidal laser
beam reflection mirror, moving from one face to the other. In this
case the distance between the reflecting surfaces of the pyramidal
laser beam reflection mirror and the scanning mirrors 13A, 13B is
constant. The trajectory of the laser beam can be increased or
decreased to increase or decrease the area of the vaginal canal
treated for each position of the retractor.
[0055] Advantageously, the four faces forming the reflecting
surfaces 25A are inclined by about 45.degree. with respect to the
axis A-A of the retractor 19, so that the beam directed nearly
parallel to the axis A-A (disregarding the slight inclination
necessary to bring the beam in an intermediate area of each
reflecting surface 25A) is reflected in a substantially orthogonal
direction to the axis A-A and therefore nearly perpendicularly to
the surface of the vaginal canal, inside which the retractor 19 has
been inserted.
[0056] Controlling the scanning mirrors 13A, 13B as described
above, it is therefore possible to treat a "slice" of the vaginal
canal wall having a not-negligible dimension in the direction of
the axis A-A of the retractor 19. Once this area of the vaginal
canal has been treated, the retractor 19 can be moved by one step
in axial direction, so as to treat in sequence the subsequent area
or slice of vaginal canal.
[0057] In advantageous embodiments of the method described above,
the laser beam is controlled so that for each position of the
retractor 19 the laser beam is controlled to make a trajectory
involving a limited portion of the pyramidal or truncated pyramidal
laser beam reflection mirror, typically in the order of some
millimeters, near the base. The axial extension of the mirror
portion used is proportional to the "slice" of vaginal canal
treated for each position of the retractor 19. The back or forward
movement of the retractor 19 between one treatment phase and the
subsequent one is preferably equal to the width of the treated
"slice" so that, once the treatment is completed, all the inner
surface of the vaginal canal has been subjected to the laser
effect.
[0058] The movement for gradually removing the retractor 19 from
the vaginal canal may be better controlled using an element acting
as a reference stop on the outside of the vaginal canal, as better
shown in FIG. 8.
[0059] To this end, in some embodiments a disc-shaped element 31 is
provided, mounted on the outside of the cylindrical body 23 of the
retractor 19. The disc-shaped element 31, provided, if necessary,
with and adequate collar 31A to increase the support surface on the
cylindrical body 23 of the retractor 19, and the cylindrical body
23 of the retractor 19 slide with respect to each other according
to the double arrow f31 (FIG. 8), so as to modify the distance
between the laser beam reflection mirror 25 and the disc-shaped
stop element 31 and consequently the depth of insertion of the
retractor in the vaginal canal.
[0060] In some advantageous embodiments, reference marks 33 may be
provided on the outer surface of the retractor 19, facilitating the
operator in positioning and moving gradually the retractor 19 with
respect to the disc-shaped stop element 31. The operator can rest
the disc-shaped stop element on the vulva structures at the
entrance of the vaginal canal and, maintaining it in this position,
move the cylindrical body 23 of the retractor 19 parallel to the
axial extension of the same retractor 19, gradually extracting it
from or inserting it into the vaginal canal, moving it from the end
where there is the bayonet coupling 21 towards the opposite end, as
the treatment of the vaginal canal tissues proceeds as described
above.
[0061] The marks 33 allow the operator to clearly identify the
position of the retractor 19 with respect to the disc-shaped
element 31 so as to treat subsequent "slices" or portions of the
vaginal canal gradually and step by step.
[0062] Substantially, the treatment method is as follows: the
retractor 19 is positioned, with respect to the disc-shaped stop
element 31, in correspondence of the mark closest to the bayonet
coupling 21, so that the retractor 19 can be completely inserted
inside the vaginal canal until the disc-shaped stop element 31
abuts the patient's body in correspondence of the vaginal canal
entrance. The operator actuates the laser and the scanning mirrors
13A, 13B so that, under the control of the programmed electronic
control unit, the laser beam treats the whole surface of the
vaginal canal that can be achieved moving the laser beam along the
reflecting surfaces 25A of the laser beam reflection mirror 25 from
the base towards the vertex of the same mirror or vice versa.
[0063] Once the treatment has been completed, the operator
partially removes the retractor 19 extracting it by one step, so
that the disc-shaped element 31 is aligned with the subsequent
mark. The distance between two adjacent marks, in the order of some
millimeters, corresponds to the dimension in axial direction of the
vaginal canal area that can be treated in a single phase, before
moving the retractor.
[0064] The operation is repeated for the different positions of the
retractor 19 with respect to the disc-shaped stop element 31 up to
the entrance of the vaginal canal.
[0065] In other embodiments the operator can act reversely,
treating firstly the area closest to the vaginal canal entrance and
gradually continuing towards the inside of the canal.
[0066] In some embodiments the treatment of each slice or area of
the vaginal canal is performed twice, rotating the retractor 19 for
instance by 45.degree. around its own axis A-A between the first
and the second treatment, thus avoiding discontinuities or
irregularities in treating the tissue in correspondence of the
edges of the pyramidal laser beam reflection mirror 25, and in
particular in correspondence of the bars 27. Rotating the retractor
19 only once by an angle different than 90.degree. (in the
illustrated example), for instance by 45.degree., there are no
areas of the vaginal canal tissue remaining untreated or treated
incompletely. A single rotation for each treatment depth is
sufficient. It is also possible to perform a first treatment for
all the depth of the canal extracting the retractor 19 step by step
and then to rotate the retractor 19 for instance by 45.degree. and
repeat the treatment for the areas not treated during the first
phase, proceeding step by step whilst the retractor in inserted
again or vice versa in case the treatment has been started
inserting the retractor step by step in the first phase.
[0067] The laser beam is advantageously pulsed and its movement in
the space is preferably controlled so as to treat adjacent but non
overlapping tissue portions. In some embodiments the laser beam may
be controlled to generate pulses with particular shape, for
instance of the type described in WO2011096003, whose content is
incorporated in the present disclosure.
[0068] Practically, the laser beam directed towards the reflecting
surfaces 25A of the pyramidal laser beam reflection mirror 25 can
be controlled so as to involve volumes of vaginal canal tissue that
are spaced from one another. FIG. 9 schematically shows an example
of a sequence of spots formed by the laser beam and indicated with
L, which can be provided directing the laser beam against the laser
beam reflection mirror 25 and reflecting it by means of this mirror
towards the wall of the vaginal canal. The laser beam involves for
instance circular areas of tissue spaced from one another by means
of areas not involved by the beam. Practically, the scanning
mirrors 13A, 13B can control the movement of the laser beam so as
to position it sequentially at each of the various points indicated
in FIG. 9. In some embodiments the laser pulse may be synchronized
with the movement of the scanning mirrors 13A, 13B, so that the
laser pulse is generated only when the scanning mirrors are fixed
in the position necessary to invest each single volume of the
vaginal canal tissue. In some embodiments, the laser beam may be
controlled so that in each position--defined by the scanning
mirrors--more than one laser pulse is "shot" on the same tissue
portion, for instance from two to four pulses.
[0069] FIG. 9 schematically shows three rows of spots L generated
by controlling the laser beam as described above. Each row is
generated arranging the scanning mirrors 13A, 13B so as to direct
the laser beam on the respective side reflecting surface 25A of the
pyramidal laser beam reflection mirror 25 at a substantially
constant distance from the base edge. Subsequent rows are generated
by moving the beam towards the vertex of the pyramid. Investing
tissue volumes spaced from one another by means of the laser beam
pulses in the spots L the tissue recovery time is much shorter than
with a continuous treatment or a treatment wherein the spots of the
laser beam overlap so as to treat the whole surface of the vaginal
canal.
[0070] In the above description specific reference has been made to
particularly advantageous embodiments for treating the vaginal
canal. It should be however understood that a device of the type
described above can be also used to treat tissues surrounding an
orifice of different nature, for instance for treating the anal
orifice, or an orifice provided surgically in a mass that is
usually compact, i.e. usually devoid of orifices. The laser beam
directed by means of the reflecting system and the scanning system
described herein can be used for instance for surgical operations
of ablation and/or cut inside a cavity, canal or orifice. The
operations can be performed by means of an endoscopy visual system
associated with the retractor, or arranged outside by means of
ultra-sounds or other imaging technology.
[0071] In the description above a retractor 19 has been
illustrated, provided with a pyramidal laser beam reflection mirror
and with a deflection system for deflecting a laser beam to convey
it towards the side wall of the vaginal canal or other natural or
surgically obtained orifice, to treat the tissue surface. In a
further embodiment, the retractor may be provided with means for
acquiring images of the treated surface. In some embodiments the
image acquisition system is integrated in the retractor and
especially in the pyramidal laser beam reflection mirror.
[0072] FIG. 12 illustrates a schematic section of a pyramidal laser
beam reflection mirror, indicated again with reference number 25,
which can be designed like the laser beam reflection mirror 25
described with reference to the previous embodiment. The laser beam
reflection mirror 25 may be inserted in a retractor 19 of the type
described above. In the embodiment of FIG. 12 a vision system,
indicated as a whole with number 101, may be housed inside of the
volume defined by the reflecting surfaces 25A of the laser beam
reflection mirror 25. The system 101 may comprise a camera or a
micro-camera 103 with a lens 106. The system 101 may also comprise
lighting means 105. In some embodiments the lighting means 105 may
comprise LEDs or other low-consumption emitters. The camera or
micro-camera 103 and the lighting means 105 may be powered by means
of a battery 107, preferably a rechargeable battery.
[0073] The system 101 may also comprise a radio transmitting
electronic circuit 109 to transmit the images acquired by means of
the camera or micro-camera 103. A suitable antenna, indicated for
instance with 111, may be associated with the laser beam reflection
mirror 25 and the radio transmitting circuit 109. In the
illustrated embodiment, the antenna 111 is arranged on the lower
base of the truncated pyramidal laser beam reflection mirror 25; it
should be however understood that said antenna may be also arranged
in a different position, for instance in correspondence of the
upper base of the truncated pyramidal laser beam reflection mirror
25.
[0074] In advantageous embodiments the lower base of the pyramidal
or truncated pyramidal laser beam reflection mirror 25 may be
formed by or closed by a window 113, made of a material transparent
to the wavelength at which the camera or microcamera 103 shoots the
images and to the radiation of the lighting means 105. A lens or
optical system 115 may be associated with the window 113 to collect
the images reflected by means of a reflecting system that collects
the images of the wall of the vaginal canal, or other orifice,
inside which the retractor 19 is inserted, and conveys these images
towards the lens 106 of the camera or micro-camera 103. In some
embodiments the reflecting system comprises a preferably conical or
truncated conical image acquisition mirror 119 for acquiring the
images coming from the side wall of the canal inside which the
retractor 19 is inserted, and reflects the images, even if
distorted, through the lens or other optical system 115 towards the
lens 106 of the camera or micro-camera 103. In some embodiments the
lens or optical system 115 may be omitted.
[0075] In some advantageous embodiments the image acquisition
mirror 119 is coaxial or nearly coaxial with the pyramidal or
truncated pyramidal laser beam reflection mirror 25, as
schematically indicated in FIG. 12, where A-A indicates the common
axis of the two mirrors.
[0076] FIG. 13 is an overall view of the members described above
and illustrated in FIG. 12, arranged in the retractor 19.
[0077] With this arrangement the camera or micro-camera 103 can
acquire the images of the surface subjected to the laser treatment,
preferably the side surface of the vaginal canal or of other
treated orifice, immediately after the passage of the laser beam,
thanks to the arrangement of the conical or truncated conical image
acquisition mirror 119 with respect to the pyramidal or truncated
pyramidal laser beam reflection mirror 25.
[0078] The electronics inside the pyramidal or truncated pyramidal
laser beam reflection mirror 25 may be encapsulated in a sealed
case to allow washing and sterilizing operations without damaging
the inner mechanisms. The batteries 109 may be recharged for
instance by means of an induction system without the need for
electric contacts.
[0079] In the embodiments of FIGS. 12 and 13 to acquire images of
the side wall this latter is lighted by means of lighting bodies or
lighting means 105 housed inside the pyramidal or truncated
pyramidal laser beam reflection mirror 25. In other embodiments the
lighting system may be arranged outside the electronics contained
inside the pyramidal or truncated pyramidal laser beam reflection
mirror 25. Light emitting elements may be for instance provided,
e.g. LEDs housed in the housing 13 together with the scanning
mirrors 13A, 13B and preferably upstream thereof. The light beams
generated by these sources can be deviated by means of the scanning
mirrors 13A, 13B towards the reflecting surfaces 25A of the
pyramidal or truncated pyramidal laser beam reflection mirror 25.
The lighting beams are reflected laterally by means of the faces or
surfaces of the pyramidal or truncated pyramidal laser beam
reflection mirror 25. Thanks to the greater diameter of the
lighting beams with respect to the laser beams, it is possible to
use the same laser beam reflection mirror 25 to reflect both the
laser beams and the lighting beams towards the side wall of the
vaginal canal or other treated orifice, so as to light this surface
and acquire, by means of the image acquisition mirror 119, the
images that will be then transmitted towards a central processing
unit, for instance through a radio transmission system or other
wireless system 109.
[0080] FIG. 11 schematically shows a retractor 19 with a generic
wireless system 119 for transmitting the images towards a receiving
system schematically indicated with 121 and interfaced with a
processing unit 123 showing the result of the image processing on a
monitor 125 or on another suitable interface. The processing unit
123 may be provided with known software for correcting the optical
distortion of the acquired images due to the conical shape of the
reflecting surface of the image acquisition mirror 119.
[0081] According to further embodiments, the device may be improved
by including therein radio-frequency treatment functionality for
radio-frequency treatment of the tissues forming the side wall of
the vaginal canal and/or of other natural or surgically obtained
orifices. FIGS. 14 and 15 show a possible configuration of
electrodes for applying radio-frequency current. They may be used
in combination with the image acquisition system or without it,
i.e. they may be integrated in a device designed according to
anyone of the embodiments described above.
[0082] In some embodiments, as illustrated in FIGS. 14 and 15, two
electrodes 131 and 133 may be applied on the outer wall of the
cylindrical body 23. The electrodes 131 and 133 have preferably
linear extension and extend for a part or the whole length of the
cylindrical body 23. In some embodiments the electrodes 131 and 133
may be housed in grooves 131A and 133A (see FIG. 15) provided on
the outer surface of the cylindrical body 23.
[0083] Advantageously, the electrodes 131 and 133 are parallel to
each other and to the longitudinal axis of the cylindrical body 23
of the retractor 19.
[0084] In some embodiments, the two electrodes 131 and 133 are
close to each other, i.e. they are arranged at the end of a limited
arc, for instance a 45.degree. arc, preferably 35.degree. arc, and
more preferably 30.degree. or less of the substantially circular
extension of the wall with circular section forming the cylindrical
body 23. In vaginal applications, the distance between the
electrodes 131 and 133 is such that it is possible to irradiate the
areas adjacent to the clitoris and the urethra with RF currents.
These RF currents have therapeutic effects in the treatment of
incontinence in women. In practical embodiments of the treatment
method, the retractor may be moved so that the irradiation with
radio-frequency currents involves the whole vaginal canal, not only
in correspondence of the clitoris but also in depth, in the areas
adjacent to the bladder.
[0085] The two electrodes 131 and 133 can be connected, by means of
suitable connectors (not shown), to a radio-frequency current
source housed in the main apparatus. The apparatus, constituted by
or housed inside the central unit 14, may be programmed so as to
coordinate the radio-frequency treatment and the laser treatment of
the tissues. These two treatments can be consecutive, simultaneous
or partially simultaneous, i.e. only partially overlapped. In some
embodiments it is possible for instance to apply the
radio-frequency current immediately before applying the laser and,
if necessary, during laser application.
[0086] To localize the radio-frequency treatment in the area where
the laser beam is applied, in advantageous embodiments the
electrodes 131, 133 are insulated for a part of their longitudinal
extension and are uncovered for instance in the area 131B, 133B in
correspondence of the free space where the laser beam reflected by
means of the laser beam reflection mirror 25 passes. The portion of
the electrodes 131, 133 housed in the seats or grooves 131A, 133A
can be insulated. In this way the radio-frequency current is
applied on tissues facing towards the pyramidal laser beam
reflection mirror 25, which can be therefore treated simultaneously
with the laser radiation and the radio-frequency current.
[0087] While specific embodiments of the invention have been shown
and described in detail to illustrate the application of the
principles of the invention, it will be understood that the
invention may be embodied otherwise without departing from such
principles.
* * * * *