U.S. patent application number 15/188948 was filed with the patent office on 2016-10-13 for vaginal remodeling device and method.
The applicant listed for this patent is VIVEVE, INC.. Invention is credited to Donald I. Galen, Jerome Jackson, Steven Marc Lopez, Russell Meirose, Ian F. Smith, Srihari Yamanoor.
Application Number | 20160296278 15/188948 |
Document ID | / |
Family ID | 49127564 |
Filed Date | 2016-10-13 |
United States Patent
Application |
20160296278 |
Kind Code |
A1 |
Galen; Donald I. ; et
al. |
October 13, 2016 |
VAGINAL REMODELING DEVICE AND METHOD
Abstract
This invention provides devices and methods for remodeling the
female genital tissue, the device comprising a treatment tip,
wherein the distal end of the treatment tip is conical, spherical,
hemispherical, oval or circular in shape. The device further
comprises one or more energy delivery elements for simultaneous
cooling of the vaginal epithelium and transmission of energy for
heating the tissues underneath the epithelium. In one embodiment,
said device may further comprise one or more of the following: one
or more temperature sensors for measuring the temperature at or
below the epithelium; one or more directional sensors mounted on
the hand piece or treatment tip; and one or more depth markers to
show the depth of penetration of the treatment tip into the vagina.
In another embodiment, this invention provides a device having a
finger holder with electrodes for remodeling the female genital
tissue.
Inventors: |
Galen; Donald I.;
(Sunnyvale, CA) ; Jackson; Jerome; (Sunnyvale,
CA) ; Lopez; Steven Marc; (Sunnyvale, CA) ;
Meirose; Russell; (Sunnyvale, CA) ; Smith; Ian
F.; (Sunnyvale, CA) ; Yamanoor; Srihari;
(Sunnyvale, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VIVEVE, INC. |
Sunnyvale |
CA |
US |
|
|
Family ID: |
49127564 |
Appl. No.: |
15/188948 |
Filed: |
June 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13835748 |
Mar 15, 2013 |
9415235 |
|
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15188948 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 34/20 20160201;
A61B 2018/1838 20130101; A61B 2034/2055 20160201; A61N 5/00
20130101; A61N 7/00 20130101; A61B 18/1815 20130101; A61B 2018/147
20130101; A61B 2018/1495 20130101; A61B 2018/1853 20130101; A61B
2018/183 20130101; A61B 2018/00023 20130101; A61B 2090/062
20160201; A61B 2018/00791 20130101; A61B 2034/2051 20160201; A61B
2018/1861 20130101; A61B 2018/00559 20130101; A61B 18/1485
20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 34/20 20060101 A61B034/20 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 16, 2012 |
CN |
201210069906.X |
Claims
1-20. (canceled)
21. A device for remodeling the female genital tissue, comprising a
treatment tip and a hand piece, wherein the treatment tip is
connected to the distal end of the hand piece via a connection
means, wherein the distal end of the treatment tip is rectangular,
curved, conical, spherical, hemispherical, oval or circular in
shape, and has a surface comprising one or more energy delivery
elements, wherein said elements have an internal surface and an
epithelium-contacting surface, and wherein the device further
comprises one or more of the following: (a) one or more temperature
sensors for measuring the temperature at or below the epithelium;
(b) one or more directional sensors; and (c) one or more depth
markers showing the depth of penetration of the treatment tip into
the vagina.
22. The device of claim 21, wherein said treatment tip is equipped
with a finger holder.
23. The device of claim 21, wherein the energy delivery elements
can be turned on and off selectively.
24. The device of claim 21, wherein the surface at the distal end
of the treatment tip is fully or partially covered by energy
delivery elements.
25. The device of claim 21, wherein the surface at the distal end
of the treatment tip is partially covered by insulated
material.
26. The device of claim 21, wherein the inside of said treatment
tip comprises an internal cooling chamber having a supply line of
coolant opposite to the internal surface of said one or more energy
delivery elements, wherein the supply line of coolant comprises a
plurality of nozzles configured to spray a coolant onto the
internal surface of said one or more energy delivery elements.
27. The device of claim 21, wherein the hand piece comprises one or
more indicators for indicating the status and/or orientation of the
device.
28. The device of claim 21, wherein the treatment tip is removable
from the hand piece.
29. The device of claim 21, wherein the temperature sensors are
thermocouples, each comprising a first and a second junction.
30. The device of claim 29, wherein the first junction is located
on the hand piece or between the energy delivery elements and said
hand piece, and wherein the second junction is located at the
distal end, proximal end, or middle of the one or more energy
delivery elements.
31. The device of claim 29, wherein the second junction comprises a
blunt end that contacts the epithelium and measures its
temperature, or a needle that penetrates the epithelium and
measures the temperature below the epithelium.
32. The device of claim 21, wherein one or more of said directional
sensors employ electromagnetic or optical mechanisms to track the
position of the treatment tip.
33. The device of claim 32, wherein said directional sensors
employing electromagnetic mechanisms are accelerometers or
gyroscopes.
34. The device of claim 21, wherein the directional sensors are
mounted proximally or distally on the hand piece, or mounted close
to the one or more energy delivery elements on the treatment
tip.
35. The device of claim 21, wherein the depth markers comprise
raised lines, indented lines or numerical markers, and are located
on the surface at the distal end of the treatment tip.
36. A system for remodeling the female genital tissue, comprising
i) a hand piece; ii) a treatment tip, wherein the treatment tip is
connected to the distal end of the hand piece via a connection,
wherein the distal end of the treatment tip is rectangular, curved,
conical, spherical, hemispherical, oval or circular in shape, and
has a surface comprising one or more energy delivery elements,
wherein said energy delivery elements have an internal surface and
an epithelium-contacting surface, and wherein the device further
comprises one or more of the following: (a) one or more temperature
sensors for measuring the temperature at or below the epithelium;
(b) one or more directional sensors; and (c) one or more depth
markers showing the depth of penetration of the treatment tip into
the vagina; and iii) an integrated controller comprising (a) a
housing; (b) a radiofrequency power source within the housing; (c)
a cooling sub-system within the housing; (d) a controller for
controlling the operation of the system; and (e) a display
configured to display information about the system.
37. The system of claim 36, wherein the energy delivery elements
can be turned on and off selectively.
38. The system of claim 36, further comprising a cable connecting
the hand piece and the integrated controller, and/or a foot switch
configured to connect to the integrated controller.
39. A method of using the device of claim 21 for remodeling a
target tissue underlying a mucosal epithelium of the female genital
tissue, comprising the step of cooling said epithelium and heating
said target tissue with said energy delivery elements.
40. The method of claim 39, wherein remodeling includes contracting
the target tissue, tightening the introitus, tightening the vagina,
denaturing collagen, or tightening collagen-rich sites of the
target tissue.
Description
RELATED APPLICATION
[0001] This application claims the priority of Chinese application
201210069906.X, filed Mar. 16, 2012. The entire contents and
disclosures of this prior application are incorporated herein by
reference into this application.
FIELD OF THE INVENTION
[0002] This invention relates to devices and methods for remodeling
tissue of the vagina and vulva, for example, by the application of
radiant energy.
BACKGROUND OF THE INVENTION
[0003] The vaginal tissue of women is stretched during vaginal
child birth; at least some of the effects of the stretching are
permanent and many women have long term medical consequences. Some
consequences may include sexual aspects, as may follow from
excessive loosening of the vagina and its opening. Such loosening
typically occurs with the first vaginal delivery, and the loosening
tends to increase with subsequent vaginal deliveries. The effect of
looseness in this region may include decreased pressure and
friction during intercourse, and as a consequence, decreased sexual
pleasure for women and their conjugal partners. Some surgical
options can be exercised in an attempt to alleviate these problems.
However, these surgical approaches are not highly popular because
of the risks associated with an invasive procedure.
[0004] Known systems and devices for treating the vagina are less
than optimal, including those using radiant energy to modify the
collagen. In particular, known systems are not optimized for the
manipulation of the device and the cooling of the treated tissue.
In addition, existing systems may not regulate the contact with the
patient's tissue optimally. Finally, known systems have not proven
to be simple, lightweight or intuitive to use. Described herein are
systems and devices that can solve all the above-mentioned
insufficiencies of known systems.
SUMMARY OF THE INVENTION
[0005] This invention provides a device and system for remodeling
the female genital tissue, the device comprising a treatment tip
and one or more energy delivery elements for simultaneous cooling
of the vaginal epithelium and transmission of energy for heating
the tissues underneath the epithelium. The device may further
comprises one or more temperature sensors for measuring the
temperature at or below the epithelium; one or more directional
sensors mounted on the hand piece or treatment tip; and one or more
depth markers to show the depth of penetration of the treatment tip
into the vagina. In another embodiment, this invention provides a
device having a finger holder with electrodes for remodeling the
female genital tissue.
DETAILED DESCRIPTION OF THE FIGURES
[0006] FIG. 1 is a perspective view of one embodiment of the device
comprising a treatment tip (1), a hand piece (2) and a connection
means (3), wherein said treatment tip has a cone-shaped distal end,
wherein energy delivery elements (4) are arranged over the curved
surface of the cone.
[0007] FIGS. 2A and 2B are perspective views of another embodiment
of a device comprising a hand piece connected to a treatment tip
that has a spherical distal end.
[0008] FIG. 3A indicates cross-sections A-A and B-B in an
embodiment of a device comprising a cone-shaped treatment tip. FIG.
3B illustrates one embodiment of a coolant spray pattern in the
internal cooling chamber (5) of a cone-shaped treatment tip,
showing some of the nozzles (6). FIGS. 3C and 3D are close-up views
of a coolant spray pattern, showing the energy delivery elements
(4).
[0009] FIG. 4 illustrates one embodiment of a hand piece.
[0010] FIGS. 5A and 5B show two views of an integrated system for
tissue remodeling.
[0011] FIG. 6A shows one embodiment of a treatment device with a
temperature sensor (11) that is adapted to measure temperature on
the surface of the genital epithelium. FIGS. 6B and 6C show other
embodiments of a treatment device with temperature sensors adapted
to measure temperature beneath the surface of the genital
epithelium.
[0012] FIG. 7A shows one embodiment of a directional sensor (7)
mounted on the distal end of a hand piece; FIG. 7B shows one
embodiment of a directional sensor (7) mounted on the proximal end
of a hand piece; FIG. 7C shows one embodiment of a directional
sensor (7) mounted on the treatment tip.
[0013] FIG. 8A shows some depth markers (8) on the treatment
surface of a treatment tip having a cone-shaped distal end; FIG. 8B
shows some depth markers (8) on the treatment surface of a
treatment tip having a rectangular distal end; FIG. 8C shows some
raised and indented depth markers on the treatment surface of a
treatment tip having a rectangular distal end.
[0014] FIG. 9 shows one embodiment of a device having a finger
holder with electrodes for remodeling female genital tissue, said
device comprising a gripping means (14), a hand piece (2), a
wrapping loop (15), a housing (13) and a wire (16).
[0015] FIG. 10 shows one embodiment of a device having a finger
holder for remodeling female genital tissue, wherein said finger
holder (12) is coupled through a connection means (3) to a hand
piece (2).
DETAILED DESCRIPTION OF THE INVENTION
[0016] Described herein are devices and systems for remodeling
target tissues underlying the epithelium of female genital tissue,
while cooling the epithelium. The systems consist of devices that
work together as a remodeling tool. In one embodiment, the device
includes a hand piece and a treatment tip, which may form part of a
system further including a power source, a source of coolant, and a
control system.
[0017] The present invention provides a device which is a component
of systems for remodeling target tissues underlying the epithelium
of female genital tissue (hereinafter called `systems`).
[0018] The device in the present invention comprises a treatment
tip (1) and a hand piece (2), wherein the treatment tip (1) is
coupled through a connection means (3) to the distal end of the
hand piece (2), wherein the distal end of the treatment tip is
conical, spherical, hemispherical, oval or circular in shape,
wherein the device further comprises one or more of the following:
one or more temperature sensors (11) for measuring the temperature
at or below the epithelium; one or more directional sensors (7);
and one or more depth markers (8) showing the depth of penetration
of the treatment tip into the vagina.
[0019] In another embodiment, the device in the present invention
comprises a treatment tip (1) and a hand piece (2), wherein the
treatment tip is coupled through a connection means (3) to the
distal end of the hand piece, wherein the device comprises one or
more temperature sensors (11) for measuring the temperature at or
below the epithelium, wherein the device further comprises one or
more directional sensors (7) mounted on the hand piece or treatment
tip. In one embodiment, the distal end of the treatment tip is
rectangular, curved, conical, spherical, oval, hemispherical or
circular in shape.
[0020] The distal end of the treatment tip comprises one or more
energy delivery elements (4) comprising an internal surface and an
epithelium-contacting surface.
[0021] The inside of the distal end of said treatment tip (1)
comprises an internal cooling chamber (5) having a plurality of
nozzles (6) configured to spray a coolant onto the internal surface
of the energy delivery elements. Said internal cooling chamber may
comprise a coolant return line that vents used coolant from the
treatment tip.
[0022] The energy delivery element comprises at least one
radiofrequency (RF) electrode.
[0023] The surface of the distal end of the treatment tip may be
fully covered by the energy delivery elements, or has one or more
areas not covered by the energy delivery elements.
[0024] In one embodiment, the energy delivery elements can be
turned on and off in a specific sequence, or in a clockwise or
counter-clockwise direction.
[0025] The energy delivery elements can cool the vaginal epithelium
and simultaneously transmit energy for heating the target
tissues.
[0026] In one embodiment, the treatment tip can be removably
attached to the hand piece of a system so as to receive
electricity, radiofrequency, coolant and/or digital signals.
[0027] In one embodiment, the temperature sensors are
thermocouples. For example, each thermocouple comprises a first and
a second junction. In one embodiment, the first junction is located
on the hand piece or between the energy delivery elements and said
hand piece. In another embodiment, the second junction is located
at the distal end, proximal end, or middle of the energy delivery
elements.
[0028] In one embodiment, the second junction comprises a blunt end
that contacts the epithelium and measures its temperature, or a
needle that penetrates the epithelium and measures the temperature
underneath the epithelium.
[0029] Directional sensors generally provide information for
tracking the position of the treatment tip. In one embodiment,
directional sensors employ electromagnetic or optical mechanisms to
track the position of the treatment tip. Directional sensors can be
mounted on various positions such as the proximal or distal end on
the hand piece or close to the energy delivery elements on the
treatment tip.
[0030] In one embodiment, the surface of the treatment tip
comprises depth markers, wherein the surface can be rectangular,
curved, conical, spherical, hemispherical, oval or circular in
shape. In one embodiment, the depth markers comprise numerical
markings.
[0031] In another embodiment, the depth markers on the treatment
tip or its surface comprise raised lines, indented lines or
numerical markings. In another embodiment, the depth markers are
located on more than one side of the treatment tip.
[0032] In another embodiment, the present invention provides a
device having a finger holder fitted with electrodes for remodeling
female genital tissue, said device comprising a gripping means (14)
and a hand piece (2), wherein the gripping means is connected to
the hand piece, wherein the gripping means has a finger holder (12)
at the proximal end, and a wrapping loop (15) at the distal end,
wherein the finger holder is attached to a housing (13), and the
surface of the housing comprises at least one energy delivery
element (4), wherein the device further comprises one or more of
the following: one or more temperature sensors (11); one or more
directional sensors (7); and one or more depth markers (8). In one
embodiment, the finger holder and hand piece are connected via
wires (16) for delivery of electricity, radiofrequency, coolant or
digital signals.
[0033] In one embodiment, the present invention provides a device
having a finger holder with electrodes for remodeling female
genital tissue, said device comprising a finger holder (12), a hand
piece (2) and a connection means (3), wherein the finger holder is
coupled through the connection means to the distal end of the hand
piece, wherein the finger holder is connected to a housing (13),
and the surface of the housing comprises at least one energy
delivery dement (4), wherein the device further comprises one or
more of the following: one or more temperature sensors (11); one or
more said directional sensors (7); and one or more said depth
markers (8).
[0034] The above-mentioned energy delivery element comprises an
internal surface and an epithelium-contacting surface. In one
embodiment, the energy delivery elements comprise at least one
radiofrequency (RF) electrode.
[0035] The housing (13) is rectangular, curved, oval, conical,
hemispherical, spherical or circular in shape. In one embodiment,
the housing comprises an internal cooling chamber (5) having a
supply line of coolant opposite to the internal surface of the
energy delivery elements, wherein the supply line of coolant
comprises a plurality of nozzles (6) configured to spray a coolant
onto the internal surface of the energy delivery elements.
[0036] In another embodiment, the present invention provides a
system for remodeling female genital tissue (hereinafter called
`system`). In one embodiment, the system comprises the treatment
tip described above, a hand piece, and an integrated controller
that comprises, for example, a housing, a radiofrequency generator
within the housing, a cooling sub-system within the housing, and a
controller for controlling the operation of the system.
[0037] This invention further provides a method of using the above
device or system for remodeling a target tissue underlying a
mucosal epithelium of the female genital tissue, comprising the
step of cooling said epithelium and heating said target tissue with
energy-delivery elements of the device or system. The content of
PCT/US2010/049045 is hereby incorporated by reference in its
entirety into this specification to illustrate a method of
remodeling the female genital tissue.
[0038] The method may comprise a step of connecting the treatment
tip to an elongated handle configured to be held by two hands. The
method may also comprise a step of confirming contact of the energy
delivery elements with the tissue based on the temperature at or
near the energy delivery elements and the time since the treatment
tip is last activated.
[0039] In one embodiment, the step of cooling the epithelium
comprises spraying coolant onto the internal surface of the energy
delivery elements, wherein the coolant may be recycled.
[0040] In said method, the target tissue may be heated to a
temperature between about 45.degree. C. and about 80.degree. C. by
applying energy from the energy delivery dements. In one
embodiment, the method comprises cooling the epithelium to a
temperature between about 0.degree. C. and about 10.degree. C. The
cooling may precede the heating, and continue during the heating.
Alternatively, cooling is performed during heating, and continues
after heating.
[0041] In one embodiment, the method comprises contacting the
epithelium with the treatment tip at one or more contact sites
during a procedure.
[0042] In said method, the female genitalia include the vulva, the
vagina and the introitus. The female genitalia may also include a
portion of the vagina extending from the introitus inwardly from
about 1 cm to about 3.5 cm. The female genitalia may include a
portion of the vagina circumferentially around its wall from about
1 o'clock to about 11 o'clock, wherein the aspect closest to the
urethra is at 12 o'clock. In one embodiment, the female genitalia
includes a portion radiating outwardly from the introitus to the
Hart's line. In another embodiment, the female genitalia includes
the mucosal surfaces of the labia minora.
[0043] In said method, the target tissue includes submucosa and
muscularis below the mucosal epithelium. In one embodiment, the
heating does not substantially modify the mucosal epithelium of the
genital tissue. In another embodiment, remodeling comprises
contracting the target tissue, tightening the introitus, tightening
the vagina, denaturing collagen, or tightening the collagen-rich
sites in the target tissue.
[0044] This invention will be better understood by reference to the
examples which follow. However, one skilled in the art will readily
appreciate that the examples provided are merely for illustrative
purposes and are not meant to limit the scope of the invention
which is defined by the claims following thereafter.
[0045] Throughout this application, it is to be noted that the
transitional term "comprising", which is synonymous with
"including", "containing" or "characterized by", is inclusive or
open-ended, and does not exclude additional, un-recited elements or
method steps.
EXAMPLES
Device for Remodeling Genital Tissues
[0046] In one embodiment, a device for remodeling female genital
tissue comprises a hand piece and a treatment tip (FIGS. 1-2). The
hand piece is adapted to be held by an operator, such as a
physician. The hand piece may include connections to a larger
supporting system, or it may be operable as a self-sufficient
independent device. In one embodiment, the treatment tip can be
configured to be removably coupled to the hand piece, for example,
the treatment tip can be designed as a quick connect/disconnect
unit with respect to its attachment to the hand piece.
Treatment Tip
[0047] In one embodiment, the treatment tip comprises a housing, a
midsection, and a treatment surface at the distal end of the
treatment tip, wherein the treatment surface is covered by one or
more energy delivery elements that each comprises an internal
surface and an epithelium-contacting surface. The energy delivery
elements are adapted to allow cooling of the epithelium while
transmitting energy to heat the target tissue. The housing defines
an interior space which extends forward to the distal end of the
treatment tip. The midsection of the treatment tip provides a
functional advantage in that it allows the energy delivery elements
to be projected forward from the body of the hand piece. The
overall length of the treatment tip can be designed to reach the
innermost region of the vagina that is to be treated.
Energy Delivery Element
[0048] In one embodiment, each energy delivery element has an
internal surface facing the interior space within the treatment
tip, and an epithelium-contacting surface facing the exterior of
the treatment tip. The internal surface may be made of a metal,
e.g. copper, gold, silver, or aluminum. The epithelium-contacting
surface may comprise a variety of different materials, including
but not limited to, polyimides, Teflon.RTM., silicon nitride,
polysilanes, polysilazanes, Kapton and similar polymers, antenna
dielectrics and other dielectric materials known in the art. Other
exemplary dielectric materials include polymers such as polyester,
silicon, sapphire, diamond, zirconium-toughened alumina (ZTA),
alumina and the like. In another embodiment, the energy delivery
dement is made of a composite material, including but not limited
to, gold-plated copper, copper-polyimide, silicon/silicon-nitride
and the like.
[0049] In one embodiment, the energy delivery element may he a
radiofrequency electrode, a microwave emitter, or an ultrasound
emitter. For example, the radiofrequency electrode is a capacitive
electrode that couples to the epithelium. In another embodiment,
the radiofrequency electrode can be either monopolar or bipolar. In
the monopolar mode, radiofrequency current flows through body
tissue from a return electrode which can be in the form of a
conductive pad applied to another portion of the patient's body.
The distal end of the treatment tip may have a pair of monopolar
electrodes, a bipolar pair, or multiple bipolar pairs.
[0050] In one embodiment, the electrode may be equipped with an
integrated EEROM (Electrically Erasable Read Only Memory, also
known as EEPROM) programmable memory chip at any suitable location
within the treatment tip. Such a chip may provide identifying
information or other information about the operational status or
configuration parameters of the radiofrequency electrode to the
system, such parameters may include, by way of example, the type
and size of the electrode, the number of times the energy delivery
element has been fired, and the like.
Treatment Surface
[0051] In one embodiment, the distal end of the treatment tip is
configured to be conical, spherical, hemispherical or of any other
desirable geometry, providing a treatment surface that is suitable
for the treatment site. Energy delivery elements are located on the
treatment surface at the distal end of the treatment tip. For
example, the energy delivery elements can be arranged on the
treatment surface at the distal end of a treatment tip that may be
conical, spherical, hemispherical, oval, circular or any other
desirable geometry. One of ordinary skill in the art would readily
design treatment surface (conical, spherical, etc.) and energy
delivery elements in different sizes (e.g. small, medium and large)
to accommodate anatomical differences of the female genital.
[0052] The energy delivery elements (or electrodes) can be arranged
on the treatment surface in a number of different patterns or array
(FIGS. 1-2). For example, the electrodes may or may not occupy the
entire treatment surface. One of ordinary skill in the art would
readily configure the dimensions of the energy delivery elements to
suit the treatment needs and the configuration of the treatment tip
so that the treatment surface and the electrodes would adequately
cover the anatomy of the target tissue. By dividing the electrodes
into multiple arrays and through the use of sensory technology, an
operator may determine which array areas are making appropriate
tissue contact and then deliver radiant energy to those specific
electrodes.
[0053] In one embodiment, certain areas on the treatment surface
are covered by an insulated material, not the energy delivery
elements; therefore, the electrodes or energy delivery elements are
absent from certain areas on the treatment surface (FIGS. 1-2).
This allows the user to avoid treating certain areas of the tissue
under treatment to improve the safety and effectiveness of the
treatment.
[0054] In another embodiment, the electrodes are present throughout
the treatment surface, but specific electrodes can be turned on/off
so that treatment is avoided in certain portions of the tissue
under treatment.
[0055] In yet another embodiment, the electrodes can be turned on
and off in any sequence or pattern to provide treatment to the
target tissue. For example, the electrodes may be turned on and off
in a clockwise or counter-clockwise direction. In another
embodiment, through remote control by means of a user interface,
specific electrodes can be turned on and off in any sequence or
pattern. In yet another embodiment, software programs can be used
to track which electrodes have been turned on and turned off to
identify and segregate untreated areas from treated areas.
Cooling Mechanism
[0056] In one embodiment, the interior space of the distal end of
the treatment tip accommodates a cooling system to cool the energy
delivery elements. For example, the interior space comprises a
cooling lumen for conveying coolant to a plurality of nozzles.
Various coolants are known in the art, e.g.
1,1,1,2-tetrafluoroethane (R134A) or carbon dioxide, which can be
stored in a reservoir under pressure. The nozzles are typically
located opposite to the internal surface of the energy delivery
elements. The coolant, upon release from the nozzles, is sprayed
onto the internal surface of the energy delivery elements and cools
the energy delivery elements as the coolant undergoes a liquid to
gas transformation. Consequently, the exterior surface (the
epithelium-contacting surface) of the energy delivery elements
would cool the epithelial tissues in contact with said surface.
[0057] One of ordinary skill in the art would recognize that any
appropriate coolant and internal cooling system may be used. In
some variations, the cooling may be electrical (e.g., via Peltier
effect or the like). Thus, in general, the cooling system of the
treatment device may include a cooling chamber. The cooling chamber
may include one or more nozzles for spraying or applying coolant.
Coolant may be applied in any appropriate pattern to the internal
surface of the energy delivery elements. For example, the spraying
pattern may be overlapping circles. In FIG. 3, the energy delivery
elements are located on a cone-shaped treatment surface, and the
nozzles are spaced opposite to the internal surface of the energy
delivery elements and emit a cone-shaped spray pattern.
[0058] Thus, in general, the cooling chamber has a plurality of
nozzles for applying coolant onto the internal surface of the
energy delivery elements. Since the internal surface of the energy
delivery elements is thermally conductive, cooling the internal
surface (even a portion of the internal surface) will result in
cooling the outer surface of the energy delivery elements, and
thereby cooling the epithelial tissue in contact with the energy
delivery elements.
Hand Piece
[0059] In general, the hand piece is sufficiently long to be easily
held by two hands. The hand piece may be relatively rigid (as
compared to the flexible, typically flat cable, for example). In
one embodiment, the hand piece (1101) is elongated, and includes a
grip region (1003) (FIG. 4). The hand piece may also include one or
more controls such as a button, slider, dial, or the like. The
control may allow the user to apply energy to the energy delivery
elements, to apply coolant, or both. The hand piece may also
include one or more indicators for indicating the status and/or
orientation of the device, such as the treatment tip. For example,
an indicator may indicate whether or not the treatment tip is
attached; whether or not the device is out of coolant;
[0060] or whether or not the device is ready for activation. In
another embodiment, an indicator may indicate the temperature of
the treatment tip (e.g., the energy delivery elements), and/or the
duration of time that the device has been active. In some
variations, the indicator includes one or more lights (e.g., LEDs,
etc.), colors (including colored lights), alphanumeric display
(e.g., a display screen or monitor), or the like. The hand piece is
typically configured to couple with the treatment tip. In some
variations, the treatment tip is configured to be capable of
quickly or easily attached to and detached from the handle.
[0061] In one embodiment, either the hand piece or the treatment
tip, or both, may include markers that indicate how deep into the
vagina the device has entered. This may allow the user to maintain
a desired depth of operation.
[0062] In one embodiment, the treatment tip is designed as a
single-use disposable component, while the hand piece is typically
reusable. Accordingly, the entire treatment tip and its parts are
to be sterilized, and individually packaged to maintain sterilized
until the package is opened, and the treatment tip is attached to a
hand piece in preparation for use.
Electronic Support System for the Device
[0063] The device described above for remodeling female genital
tissue may be included in a larger electronic system. The system
may include a power source, such as a radiofrequency power source
that provides energy to the radiofrequency electrodes. The system
may also include a multiplexer driven by a controller, which can be
a digital or analog controller, or a computer. When the controller
is a processor (such as a microprocessor of a computer), it can
include a CPU coupled through a system bus. There may also be a
keyboard, disk drive, or other nonvolatile memory systems, a
display, and other peripherals on the system. A program memory and
a data memory may also be coupled to the bus.
[0064] In another embodiment, the electronic support system may
include an operator interface comprising operator controls and a
display. The operator controls can be coupled to different types of
imaging systems including ultrasonic and impedance monitors.
Current and voltage are used to calculate impedance. A diagnostic
phase can be initially run to determine the level of treatment
activity. This can be done through ultrasound as well as other
means. Diagnostics can be performed both before and after
treatment.
[0065] One of ordinary skill in the art would readily design an
appropriate electronic support system for the device. Circuitry,
software and feedback to controller result in full process control
and are used to change power, the duty cycle, monopolar or bipolar
energy delivery, flow rate and pressure, and can also determine
when the process is completed through time, temperature and/or
impedance. Furthermore, a controller can provide multiplexing,
monitor circuit continuity, and determine which radiofrequency
electrode is activated. When the values exceed the predetermined
temperature or impedance values, a warning can be given on the
display. Additionally, the delivery of radiofrequency energy to the
electrodes under warning can be decreased or multiplexed to another
electrode.
System for Remodeling Target Tissues
[0066] In one embodiment, a vaginal remodeling system (hereinafter
called `system`) may include a hand piece, a disposable (or
reusable) treatment tip, a power source or supply, a cooling
sub-system, and a controller. In some variations, the controller,
power supply or source and cooling sub-system may be integrated
into a single unit to which the hand piece and treatment tip may be
coupled (FIGS. 5A and 5B). The integrated system (1500) in this
example includes a display (1501) and a housing (1503) to which the
hand piece (1505) and treatment tip (1507) are attached via a cable
(1509). The cable may include supply and return coolant lines, as
well as a connection to the radiofrequency energy supply and any
sensors on the treatment device. This entire system may be
configured for ease of use, including portability and compact
arrangement.
[0067] For example, in one variation, the system may include: a
treatment tip (for delivery of radiofrequency energy), a source of
coolant (e.g., cryogen), a hand piece, a cable connecting the hand
piece and treatment tip to the source of coolant, power source,
and/or control system or a controller.
[0068] In one embodiment, the hand piece is connected via a single
cable to an integrated controller, which includes both a cooling
system and power source that may be controlled or regulated by the
controller. The cable may include supply and return coolant lines,
as well as a connection to the radiofrequency energy supply and any
sensor(s) on the treatment device.
[0069] In one embodiment, the integrated system may include an
opening into which a coolant may be inserted. For example, the
coolant may be a pressurized canister (1521) of any appropriate
cryogen. The coolant canister may be threaded with one or more sets
of threads to secure it into place in the integrated system,
although any appropriate sealing mechanism for the coolant may be
used. The level of coolant may be monitored by the system, and the
display may include an icon indicating the level of coolant
remaining in the canister or system.
[0070] In one embodiment, the components of the integrated
controller include a microprocessor (which may include hardware,
software, and/or firmware) for controlling the system, any outputs
(e.g., monitor, one or more speakers, etc.), the radiofrequency
power source, and the cooling sub-system. These different
components of the integrated controller may be individually
installed within the housing in a "modular" manner.
[0071] The overall weight and footprint of the integrated system,
and particularly the integrated controller, may be sufficiently
small so that the system for tissue remodeling is portable and
readily storable. For example, the entire system may weigh less
than 50 pounds.
[0072] The system may also include one or more controls for
controlling the device. In particular, the system may include a
control for controlling the energy delivery of the treatment device
(e.g., activation control), as well as one or more controls for
controlling the treatment regime.
[0073] The controller may include a display that is configured to
display information about the procedure, the coolant, the treatment
tip, handle and other components of the system. This information
may be displayed on the front of the integrated controller, and may
present the information with audio signals as well. The display may
also be used to display error information (including error codes)
based on the status of the various system component (e.g., coolant
level, contact with skin, radiofrequency generator status, etc.) In
one embodiment, the display screen is a touch screen that allows
the user to select treatment parameters by touching the screen. In
some variations, the system may include a keyboard, mouse,
trackball, or the like.
[0074] In some variations, the activation control is on the hand
piece, e.g. a button. In one embodiment, the system may include a
wired or wireless foot switch or other control that is separate
from the hand piece. In one variation, the foot switch is connected
to the integrated control.
Temperature Sensors
[0075] One of the factors that need to be controlled during
treatment is the temperature of the area being treated. This can be
achieved through a temperature sensor such as a thermocouple. All
temperature sensors known in the art can be used. A sensory device
such as a thermocouple works by comparing the difference in
temperature between two junctions. One of the junctions is a
reference junction and the other is placed at the target area.
[0076] In one configuration of the invention, a junction of a
thermocouple is placed on the treatment electrode/energy delivery
dements. For example, to measure temperature on the surface of the
genital tissue, a junction is designed to be a short blunt needle
that is innocuous and would not cause injury to the tissue (FIG.
6A). Alternatively, to measure temperature underneath the
epithelium, a junction is designed to comprise a needle that
penetrates the epithelial tissue and reaches a specific depth of
the target tissue where temperature data is gathered (FIGS.
6B-6C).
[0077] In one embodiment, the junction in contact with the target
tissue may be positioned at the distal end or center of the energy
delivery elements, or close to the proximal end of the hand piece
(FIGS. 6A-6C).
[0078] In another embodiment, there may be more than one pair of
temperature measuring junctions placed on the energy delivery
elements in contact with the target tissue. This will allow for
comparative temperature measurements or for temperature monitoring
across the energy delivery elements.
[0079] In one embodiment, the reference junction of the
thermocouple that is not contacting the tissue may be placed
between the energy delivery elements and the hand piece, or on the
hand piece.
[0080] Feedback obtained from the temperature measurement can be
fed into a control unit and be displayed, and/or used for producing
alarms as necessary. The temperature feedback may also be used to
assess treatment effectiveness or to shut off the treatment when a
target temperature has been reached or exceeded. The alarms and
messages may be in the form of visual readouts and/or audio
outputs.
Directional Sensors
[0081] In a typical treatment procedure, the energy delivery
elements on the distal end of the treatment tip can contact various
sites in the lower vagina. A set of contact sites would
collectively form a treatment area on the vaginal epithelium. The
energy delivery elements (or the treatment surface comprising the
energy delivery dements) can be applied to the contact sites or
treatment area in many ways. For example, the energy delivery
elements can treat the contact sites in a clockwise or
counter-clockwise manner, or at pre-determined time intervals.
Since treatments may vary from patient to patient, or even within
the same patient, directional sensors are integrated into the
device to provide the user with appropriate information on the
position of the treatment tip. In one embodiment, sensory
information may be Obtained from more than one sensor in the tissue
remodeling system, and the sensory information from each sensor can
be used individually or collectively.
[0082] A number of sensory feedback mechanisms generally known in
the art can be used in the present invention. In one embodiment,
the sensory feedback may be obtained through electromagnetic
sensory mechanisms or through sensors like accelerometers or
gyroscopes, where an initial position is noted and any changes in
position are noted by changes in distance, angle or other
comparative means, such as changes in yaw, pitch, or roll etc.
[0083] In another embodiment, sensory feedback can also be obtained
through optical means through the measurement of light. For
example, optical encoder discs are used to measure changes in
position using a light source and photo or reflective sensors.
[0084] In another embodiment, sensory feedback can also be obtained
through optical means through the measurement of light. For
example, optical encoder discs are used to measure changes in
position using a light source and photo or reflective sensors.
[0085] In one embodiment, the directional sensors may be positioned
proximally or distally on the hand piece (FIGS. 7A-B). In another
embodiment, the sensors can be positioned near the energy delivery
elements on the treatment tip (FIG. 7C).
[0086] In one embodiment, sensory information from the directional
sensors is processed and displayed to alert users as to the current
position of the treatment tip, other positions it has been in, the
direction of treatment and other pertinent information.
[0087] In another embodiment, sensory information obtained from a
treatment device may activate alarms indicating if the treatment
device is approaching a new treatment site, if it is traversing a
site that has already been treated, or if there has been a change
in the treatment direction.
[0088] Sensory information regarding the treatment process for a
given patient may be stored as reference and used for comparison in
future treatments or other purposes.
[0089] Sensory information obtained from the directional sensors
would have many applications. For example, it provides information
on the specific location of the treatment device on the treatment
area. In treating patients, it may be necessary to vary the energy
delivery scheme, the quantity of energy delivered, coolants or
other components used to assist treatment, etc. Thus, the position
of the treatment device on the treatment area can be used for one
or more purposes: [0090] 1. The position of the treatment device
may indicate whether or not treatment or any supplementary
components would be necessary. Thus, information regarding the
position can be used to determine whether the treatment should be
started or stopped, and if use of any supplementary materials (e.g.
coolants) need to be started or stopped. [0091] 2. The position of
the treatment device may be used to vary the amount of energy
delivered, or the amount of any supplementary materials used. These
changes may improve the efficiency and safety of the treatment.
Thus, based on the changes in the position of the device, and the
direction of movement of the device towards specific treatment
areas, various treatment parameters may be changed. [0092] 3. The
changes in the treatment materials and/or parameters can either be
programmed directly into the treatment control device, or be
manually controlled if necessary.
Depth Markers
[0093] In one embodiment, the tissue remodeling device described
above can be used to treat vagina of different shapes and depths.
The depth at which the treatment surface at the distal end of the
treatment tip penetrates the vagina or other target tissue can
affect the safety and/or effectiveness of the treatment.
Accordingly, markers on the treatment device allow a user to
quickly assess the depth at which the treatment surface/treatment
device has penetrated the vagina. The location of the markers will
depend on the configuration of the device itself.
[0094] In one embodiment, scale markers accompanied by raised
reference lines or other similar features help the user either
visually or through sense of touch to determine the depth of
penetration. Alternatively, the scale markers are indented instead
of raised. In another embodiment, the scale markers can be raised
markers on one side of the treatment tip and be indented markers on
another side. Any of the above marker schemes can be placed on one
or more sides of the treatment tip to help the user manipulate the
device while maintaining it at a specific depth within the
vagina.
[0095] In case the distal end of the treatment tip is conical (or
spherical, circular, etc.) in shape, depth markers (8) can surround
the treatment surface or cover part of the surface (FIG. 8A). This
will be useful when the treatment device is rotated or inserted
during the treatment process.
[0096] In one embodiment, numerals can be used as depth markers to
show the depth of penetration (FIGS. 8A, 8B). This numeric scale
can include numbers and unit of measurement such as inches,
millimeters or centimeters. These numbers can be printed on the
treatment tip, flush with the surface of the treatment tip. In
another configuration, the numbers may be raised or indented to
enhance the visual effect and sense of touch.
[0097] The numeric markers may also be printed with colors that
substantially contrast the color of the treatment tip. For example,
if the treatment tip is black, the markers could be white, or vice
versa. This color contrast will allow for easy visual recognition
of the treatment depth.
[0098] In another embodiment, the numbers and markers can he
staggered in multiple colors to display different depths of
penetration, such as using three different colors to depict
shallow, medium or deep.
[0099] In another embodiment, the numbers and markers can be
staggered with two different colors as safety indicators. A certain
depth may be considered safe, and this may be indicated using green
color for example, and a depth considered unsafe may be indicated
using red. Other contrasting colors could also be used.
[0100] In summary, markers located on the treatment tip enable the
user to quickly determine if the tissue remodeling treatment tip
has reached the depth of the target vaginal tissue. The markers and
numerals are located on the treatment surface at the distal end of
the treatment tip. In another embodiment, the markers are near the
proximal end of the treatment tip. In yet another embodiment, the
markers could be located at multiple positions on the treatment tip
for added convenience.
Device with Finger Holder
[0101] In one embodiment, the treatment device comprises a gripping
means (14) and a hand piece (2), wherein the gripping means is
connected to the hand piece, wherein the gripping means has a
finger holder (12) at the proximal end, and a wrapping loop (15) at
the distal end, wherein the finger holder is connected to a housing
(13), and the surface of the housing comprises at least one energy
delivery element (4) (FIG. 9).
[0102] In one embodiment, the finger holder is connected to a rod
and a strap that can wrap around the user's hand or arm so that the
device may be held firmly (e.g. a wrist band, see FIG. 9). This
will allow the user to access and withdraw from the treatment site
without losing the grip, thus promoting safety, treatment
effectiveness and user comfort.
[0103] In one embodiment, the finger holder (12) is connected to
the hand piece (2) via wires (16) to deliver electricity,
radiofrequency, coolant and/or digital signals. The housing (13) is
rectangular, curved, oval, conical, hemispherical, spherical or
circular in shape.
[0104] In another embodiment, the finger holder is connected to the
hand piece without the rod and wristband (FIG. 10). This will allow
a user to pull his/her finger out of the finger holder and just
grasp the hand piece after the energy delivery elements have been
placed into the treatment site. The treatment device comprises a
finger holder (12), a hand piece (2) and a connection means (3),
wherein the finger holder is coupled through the connection means
to the distal end of the hand piece, wherein the finger holder is
connected to a housing (13), and the surface of the housing
comprises at least one energy delivery element.
[0105] In one embodiment, the finger holder can be designed to
accommodate a wide variety of finger sizes, both male and female.
One way to achieve this would he through the use of finger holders
and electrodes of matching sizes, or the use of sleeves of
different internal diameters inside the finger holder. Another
approach is making the finger holder with soft materials that will
adapt to various finger sizes. The finger holder will allow the
physician/user/treatment provider to easily reach the treatment
site, thus achieving different advantages such as accuracy and
speed of treatment.
[0106] In one embodiment, the energy delivery elements are part of
a housing that accommodates a cooling chamber to cool the energy
delivery elements. For example, the cooling chamber may comprise a
cooling lumen for conveying coolant to one or more nozzles. Various
coolants are known in the art, e.g. 1,1,1,2-tetrafluoroethane (R
134A) or carbon dioxide Which can be stored under high pressure.
The energy delivery elements comprise an epithelium-contacting
surface and an internal surface facing the cooling chamber. In one
embodiment, the nozzles are located opposite to the internal
surface of the energy delivery elements. The coolant, upon release
from the nozzles, is sprayed onto the internal surface of the
energy delivery elements and cools the surface as a result of
vaporization. Consequently, the exterior epithelium-contacting
surface of the energy delivery elements would cool the epithelial
surface of the target tissue.
[0107] Treatment of target tissue is achieved by inserting a finger
into the finger holder and directly applying the energy delivery
elements onto the treatment site. The energy delivery elements can
be moved in a clockwise or counter-clockwise direction on the
treatment site. One of ordinary skill in the art would readily
configure the dimensions and sizes of the energy delivery elements
to provide optimal treatment.
[0108] In one embodiment, the energy delivery element may be a
radiofrequency electrode, a microwave emitter, or an ultrasound
emitter. In one embodiment, the radiofrequency electrode is a
capacitive electrode in contact with the mucosal epithelium.
* * * * *