U.S. patent application number 15/050287 was filed with the patent office on 2016-06-16 for methods and apparatus for preventing vaginal lacerations during childbirth.
The applicant listed for this patent is Mark JURAVIC, Michael STEWART. Invention is credited to Mark JURAVIC, Michael STEWART.
Application Number | 20160166282 15/050287 |
Document ID | / |
Family ID | 43876851 |
Filed Date | 2016-06-16 |
United States Patent
Application |
20160166282 |
Kind Code |
A1 |
JURAVIC; Mark ; et
al. |
June 16, 2016 |
METHODS AND APPARATUS FOR PREVENTING VAGINAL LACERATIONS DURING
CHILDBIRTH
Abstract
A vaginal dilation device is provided that may include any of a
number of features. One feature of the vaginal dilation device is
that it is configured to dilate vaginal tissue during labor to
prevent tissue damage. Another feature of the vaginal dilation
device is that it can be manually controlled to dilate vaginal
tissue, or can be automatically controlled to dilate vaginal
tissue. In some embodiments, the vaginal dilation device is
configured to measure a force applied by the device to tissue. In
other embodiments, the vaginal dilation device is configured to
apply a constant force to tissue. In other embodiments, the vaginal
dilation device is configured to expand at a constant rate. Methods
associated with use of the vaginal dilation device are also
provided.
Inventors: |
JURAVIC; Mark; (San
Francisco, CA) ; STEWART; Michael; (San Jose,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
JURAVIC; Mark
STEWART; Michael |
San Francisco
San Jose |
CA
CA |
US
US |
|
|
Family ID: |
43876851 |
Appl. No.: |
15/050287 |
Filed: |
February 22, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13876920 |
Jun 14, 2013 |
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PCT/US2011/032324 |
Apr 13, 2011 |
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15050287 |
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PCT/US2010/052528 |
Oct 13, 2010 |
|
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13876920 |
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Current U.S.
Class: |
606/121 |
Current CPC
Class: |
A61B 2017/00119
20130101; A61B 2017/345 20130101; A61B 5/22 20130101; A61B 2090/065
20160201; A61B 17/3439 20130101; A61B 1/303 20130101; A61B
2017/00199 20130101; A61B 17/02 20130101; A61B 2090/036 20160201;
A61B 90/03 20160201; A61B 5/4343 20130101; A61M 29/02 20130101;
A61B 17/0206 20130101; A61B 5/435 20130101; A61B 5/4836 20130101;
A61B 17/42 20130101; A61B 17/3423 20130101; A61B 5/227 20130101;
A61B 1/31 20130101; A61B 90/06 20160201 |
International
Class: |
A61B 17/42 20060101
A61B017/42; A61B 5/22 20060101 A61B005/22; A61B 5/00 20060101
A61B005/00 |
Claims
1. A method of dilating a vagina of a patient during labor,
comprising: inserting a dilation device into the vagina of the
patient; dilating the vagina with the dilation device; measuring a
diameter of the dilation device with a diameter sensor; and
stopping dilating the vagina when the dilation device reaches a
target diameter.
2. The method of claim 1 wherein the inserting step further
comprises inserting the dilation device into the vagina during a
first phase of labor.
3. The method of claim 2 further comprising removing the dilation
device from the vagina prior to a second phase of labor.
4. The method of claim 1 wherein the dilating step further
comprises automatically dilating the vagina with the dilation
device.
5. The method of claim 1 further comprising dilating the vagina
with the dilation device based on the measured diameter.
6. The method of claim 1 further comprising measuring a force
applied to the dilation device.
7. The method of claim 6 further comprising dilating the vagina
with the dilation device based on the measured force and/or the
measured diameter.
8. The method of claim 1, the dilating step further comprising
dilating the vagina at a constant force with the dilation
device.
9. The method of claim 1, wherein the target diameter comprises
between 7-10 cm.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/876,920, filed Jun. 14, 2013, which is a national phase of
International Application No. PCT/US2011/032324, filed Apr. 13,
2011, which application is a continuation-in-part of International
Application No. PCT/US2010/052528, filed Oct. 13, 2010. These
applications are herein incorporated by reference in their
entirety.
INCORPORATION BY REFERENCE
[0002] All publications, including patents and patent applications,
mentioned in this specification are herein incorporated by
reference in their entirety to the same extent as if each
individual publication was specifically and individually indicated
to be incorporated by reference.
FIELD OF THE INVENTION
[0003] Devices and methods are described generally relating to
preparing tissue for childbirth. More specifically, the devices and
methods described herein are intended to prepare and dilate vaginal
tissue during labor so as to prevent pelvic floor damage, and
vaginal and perineal lacerations.
BACKGROUND OF THE INVENTION
[0004] Approximately 134 million women give birth worldwide each
year, of whom 3.0 million give birth vaginally in the United
States. Approximately 8 out of 10 women who give birth vaginally
will experience some degree of vaginal tearing. In the U.S, roughly
1.2 million, or 40%, experience a spontaneous laceration or
episiotomy (planned surgical cut for high risk patients) that
requires surgical repair. Between 1.5% and 15% of lacerations are
considered severe and require extended healing time and pain
management, and can result in difficult reparative surgery and a
considerable decrease in quality of life measurements.
Additionally, 15-35% of women suffer damage to their pelvic floor
muscles, where the muscles are being physically pulled off of the
pelvic bone or over-stretched to the point where they become
functionally impaired. The direct costs of treating perineal
lacerations to the healthcare system is estimated to total over
$650 million each year, with treatments aimed at future pelvic
floor disorders even higher.
[0005] Specific risk factors for perineal lacerations during
childbirth have been identified, leading to above-average incidence
in patient populations. These risk factors include nulliparity
(primigravidity, first pregnancy), short perineal body,
instrumental delivery (forceps-assisted delivery, vacuum-assisted
delivery), prolonged second stage of labor (>1 hour), epidural
analgesia, intrapartum infant factors (birth weight over 4 kg,
persistent occipitoposterior position, shoulder dystocia),
episiotomy, mediolateral or midline, previous anal sphincter tear,
maternal age >30, and Asian ethnicity. In addition to the risk
factors listed above, perineal lacerations have been linked with a
higher incidence of many pelvic floor disorders such as infection,
incontinence and prolapse. In general, pregnancy and birth have
been linked as a cause of many pelvic floor disorders. However, the
exact physiologic mechanisms that lead to many of these disorders
are under investigation. It is thought that damage to the pelvic
floor musculature during childbirth may be one of the most
significant causes of pelvic floor disorders.
[0006] During vaginal delivery, labor and delivery are clinically
divided into three stages. The first stage begins with cervical
effacement and is completed with full cervical dilation that will
allow the passage of the fetus through the birth canal. The second
stage is defined by the passage of the fetus through the birth
canal, described as the Cardinal Movements of Labor. It begins with
complete cervical effacement and dilation and ends in the delivery
of the fetus. The third stage is comprised of the separation and
expulsion of the placenta.
[0007] During the first phase of labor, the birth canal is
functionally closed and maintained in proper position by a number
of layers of muscular and connective tissues that collectively form
the pelvic floor. During the second phase of labor, the presenting
part of the fetal head descends into the birth canal and exerts
direct pressure on the pelvic floor. The fetus passes through the
birth canal by stretching the fibers of the levator ani muscle and
connective tissues, drastically distending and damaging the pelvic
floor musculature, and stretching the perineum into a thin
membranous structure that often lacerates during the process of
delivery.
[0008] Pelvic floor and perineal tissues dilate rapidly during the
second phase of labor. The introitus, or opening of the vagina, for
the average woman, has a baseline resting diameter of roughly 2.6
cm. During the first phase of labor, while the cervix is dilating,
the vagina stays at this baseline diameter and only when the baby
has passed through the cervix does this tissue dilate from 2.6 cm
up to 10 cm, the average head diameter of a newborn baby. This
3.8.times. expansion in diameter and approximately 15.times.
expansion in area occurs in a matter of seconds to minutes.
[0009] Currently, there are no devices or tools that have proven to
significantly reduce trauma to the pelvic floor during vaginal
delivery, and there are no other devices that can be used to
isolate the variables associated with pelvic floor disorders
resulting from childbirth. No effective treatments exist to assist
a woman in preconditioning the tissues of the vagina and perineum
prior to and during labor.
[0010] Historically, gourds of increasing size have been used in
Africa in an attempt to prepare the tissue for labor. Today, there
are techniques such as perineal massage, hot compresses and
"hands-on" delivery that can be performed in the hospital and have
anecdotally showed promise, but none of these have been proven to
be effective in the clinical trial setting.
[0011] One device previously introduced with the goal of
pre-stretching tissue to prevent lacerations is called the Epi-No.
The Epi-No is a small balloon that was intended to be used at home
by the pregnant woman, 1-3 months before the baby was due. The goal
was to inflate the balloon up to approximately 5 cm, at which time
the woman would then practice pushing out the device. A problem
with such a balloon-style dilator is that it can change in shape
and size during expansion, which can result in poor stability of
the device in the vagina and inability to accurately gauge and
control the amount of dilation.
[0012] Vaginismus is a condition that causes involuntary tightness
of the vagina during intercourse, caused by involuntary
contractions of the pelvic floor muscles surrounding the vagina.
Vaginismus can be painful, thereby preventing enjoyment of
intercourse. Vaginal dilators combined with appropriate exercises
have helped some women overcome these involuntary muscle
contractions.
SUMMARY OF THE INVENTION
[0013] A vaginal dilation device is provided comprising a handle, a
plurality of arms coupled to the handle, each arm having a pad
disposed thereon that is shaped and configured to conform to a
vagina, an expansion mechanism coupled to the arms and configured
to move the arms and the pads radially outwards from the device,
and a force sensor disposed on the device and configured to measure
a force applied against the pads.
[0014] In some embodiments, each of the plurality of arms comprises
a scissor-like assembly coupled to each of the pads. The expansion
mechanism can be coupled to a central rod which is coupled to the
handle and the arms, wherein axial movement of the central rod
changes a distance of the pads from the central rod.
[0015] In one embodiment, actuation of the expansion mechanism is
configured to move the central rod proximally towards the handle to
move the arms and pads radially outwards from the central rod.
[0016] In some embodiments, the pads are arranged in a
substantially parallel configuration as the arms and pads move
radially outwards.
[0017] In some embodiments, the vaginal dilation device further
comprises a closed configuration wherein the pads are arranged
circumferentially around the central rod, and an expanded
configuration wherein the pads are extended away from the central
rod and away from adjacent pads. In one embodiment, an outer
diameter of the pads in the closed configuration is less than 4 cm.
In another embodiment, an outer diameter of the pads in the
expanded configuration is approximately 8-10 cm.
[0018] In one embodiment, the vaginal dilation device further
comprises a quick-release mechanism configured to quickly reduce an
outer diameter of the device. In some embodiments, the device
further comprises an actuation mechanism disposed on the handle
that is configured to engage the quick-release mechanism. In
another embodiment, the device further comprises a bump-release
disposed on a distal portion of the device that is configured to
engage the quick-release mechanism. In some embodiments, the
bump-release is configured to be engaged by a baby entering a
vaginal canal.
[0019] In some embodiments, a center of mass of the vaginal
dilation device shifts forward under the pads as the device is
expanded from the closed configuration to the expanded
configuration.
[0020] In one embodiment, the vaginal dilation device further
comprises a diameter sensor configured to indicate a dilation
diameter of the vagina.
[0021] In some embodiments, the vaginal dilation device further
comprises a controller coupled to the expansion mechanism and the
force sensor, the controller configured to automatically move the
arms and the pads radially outwards based on the force measured by
the force sensor. For example, in some embodiments, the force
sensor can measure a force applied by the pads, and the controller
can automatically expand or contract the device based on the
measured force. The controller can automatically increase the
applied force if the measured force is too low, or can
automatically decrease the applied force if the measured force is
too high (e.g., the applied force is above a force threshold).
[0022] In some embodiments, the controller is configured to
automatically move the arms and the pads radially outwards to apply
a constant force to the vagina with the pads. In some embodiments,
the vaginal dilation device further comprises a motor coupled to
the central rod and a controller coupled to the force sensor and
the motor, the controller configured to automatically move the
central rod axially, and the arms and the pads radially outwards,
based on the force measured by the force sensor. In some
embodiments, the device further comprises a controller coupled to
the expansion mechanism and the force sensor, the controller
configured to automatically move the arms and the pads radially
outwards until the force measured by the force sensor exceeds a
force threshold.
[0023] In other embodiments, the controller is configured to
automatically move the central rod axially to apply a constant
force with the pads.
[0024] In some embodiments, the expansion mechanism is configured
to automatically move the arms and the pads of the device radially
outwards at a constant force. In some embodiments, the expansion
mechanism comprises a spring coupled to the central rod, wherein
the spring pushes against the central rod with a constant force to
move the arms and the pads radially outwards from the central rod.
In one embodiment, the constant force of the spring is user
adjustable.
[0025] In some embodiments, a force applied by the spring to the
dilation device can be adjusted. In other embodiments, the spring
can be an adjustable clock spring. In some embodiments, a pivot
point of the spring can be adjusted.
[0026] Some embodiments of the vaginal dilation device further
comprise an expandable sheath disposed over the pads. Other
embodiments further comprise a working channel disposed on or in
the device.
[0027] In some embodiments of the vaginal dilation device, the
force sensor comprises a plurality of force sensors disposed on the
pads. In other embodiments, the force sensor comprises a plurality
of force sensors disposed under the pads. In other embodiments, the
force sensor comprises a plurality of force sensors disposed on the
plurality of arms.
[0028] Some embodiments of the vaginal dilation device further
comprise a clutching mechanism configured to prevent over-expansion
of the pads. Other embodiments further comprise an automatic
oscillation mechanism configured to prevent pressure necrosis.
[0029] In one embodiment of the vaginal dilation device, none of
the pads contact a urethra or any nerve bundles positioned along an
anterior portion of the vagina of the patient when the pads move
radially outwards from the device. In other embodiments, none of
the pads contact a perineum of the patient when the pads move
radially outwards from the device.
[0030] In some embodiments, the expansion mechanism is remotely
coupled to the arms via a flexible assembly.
[0031] In some embodiments, the vaginal dilation device further
comprises a cam coupled to the expansion mechanism to linearize a
force needed to expand the device from a closed configuration to an
expanded configuration. In one embodiment, the cam is a ratcheted
cam. In another embodiment, the cam is a geared cam mechanism with
multiple gears. In some embodiments, a lever or bump mechanism can
be utilized to linearize the force needed to expand the device from
the closed configuration to the expanded configuration.
[0032] In some embodiments, the expansion mechanism can comprise a
stent or yurt-like device. In other embodiments, the expansion
mechanism can comprise a living hinge structure.
[0033] Another vaginal dilation device is provided, comprising, a
handle, a plurality of arms coupled to the handle, each arm having
a pad disposed thereon that is shaped and configured to conform to
a vagina, and an expansion mechanism coupled to the arms and
configured to move the arms and the pads radially outwards from the
device at a constant force.
[0034] In some embodiments, each of the plurality of arms comprises
a scissor-like assembly coupled to each of the pads. The expansion
mechanism can be coupled to a central rod which is coupled to the
handle and the arms, wherein axial movement of the central rod
changes a distance of the pads from the central rod.
[0035] In one embodiment, actuation of the expansion mechanism is
configured to move the central rod proximally towards the handle to
move the arms and pads radially outwards from the central rod.
[0036] In some embodiments, the pads are arranged in a
substantially parallel configuration as the arms and pads move
radially outwards.
[0037] In some embodiments, the vaginal dilation device further
comprises a closed configuration wherein the pads are arranged
circumferentially around the central rod, and an expanded
configuration wherein the pads are extended away from the central
rod and away from adjacent pads. In one embodiment, an outer
diameter of the pads in the closed configuration is less than 4 cm.
In another embodiment, an outer diameter of the pads in the
expanded configuration is approximately 8-10 cm.
[0038] In one embodiment, the vaginal dilation device further
comprises a quick-release mechanism configured to quickly reduce an
outer diameter of the device. In some embodiments, the device
further comprises an actuation mechanism disposed on the handle
that is configured to engage the quick-release mechanism. In
another embodiment, the device further comprises a bump-release
disposed on a distal portion of the device that is configured to
engage the quick-release mechanism. In some embodiments, the
bump-release is configured to be engaged by a baby entering a
vaginal canal.
[0039] In some embodiments, a center of mass of the vaginal
dilation device shifts forward under the pads as the device is
expanded from the closed configuration to the expanded
configuration.
[0040] In one embodiment, the vaginal dilation device further
comprises a diameter sensor configured to indicate a dilation
diameter of the vagina.
[0041] In some embodiments, the vaginal dilation device further
comprises a controller coupled to the expansion mechanism and the
force sensor, the controller configured to automatically move the
arms and the pads radially outwards based on the force measured by
the force sensor. For example, in some embodiments, the force
sensor can measure a force applied by the pads, and the controller
can automatically expand or contract the device based on the
measured force. The controller can automatically increase the
applied force if the measured force is too low, or can
automatically decrease the applied force if the measured force is
too high (e.g., the applied force is above or below a desired
constant force threshold).
[0042] In some embodiments, the controller is configured to
automatically move the arms and the pads radially outwards to apply
a constant force to the vagina with the pads. In some embodiments,
the vaginal dilation device further comprises a motor coupled to
the central rod and a controller coupled to the force sensor and
the motor, the controller configured to automatically move the
central rod axially, and the arms and the pads radially outwards,
based on the force measured by the force sensor. In some
embodiments, the device further comprises a controller coupled to
the expansion mechanism and the force sensor, the controller
configured to automatically move the arms and the pads radially
outwards to maintain the force applied by the device at the
constant force. In other embodiments, the controller is configured
to automatically move the central rod axially to apply a constant
force with the pads.
[0043] In some embodiments, the expansion mechanism is configured
to automatically move the arms and the pads of the device radially
outwards at a constant force. In some embodiments, the expansion
mechanism comprises a spring coupled to the central rod, wherein
the spring pushes against the central rod with a constant force to
move the arms and the pads radially outwards from the central rod.
In one embodiment, the constant force of the spring is user
adjustable.
[0044] Some embodiments of the vaginal dilation device further
comprise an expandable sheath disposed over the pads. Other
embodiments further comprise a working channel disposed on or in
the device.
[0045] In some embodiments of the vaginal dilation device, the
force sensor comprises a plurality of force sensors disposed on the
pads. In other embodiments, the force sensor comprises a plurality
of force sensors disposed under the pads. In other embodiments, the
force sensor comprises a plurality of force sensors disposed on the
plurality of arms.
[0046] Some embodiments of the vaginal dilation device further
comprise a clutching mechanism configured to prevent over-expansion
of the pads. Other embodiments further comprise an automatic
oscillation mechanism configured to prevent pressure necrosis.
[0047] In one embodiment of the vaginal dilation device, none of
the pads contact a urethra or any nerve bundles positioned along an
anterior portion of the vagina of the patient when the pads move
radially outwards from the device. In other embodiments, none of
the pads contact a perineum of the patient when the pads move
radially outwards from the device.
[0048] In some embodiments, the expansion mechanism is remotely
coupled to the arms via a flexible assembly.
[0049] In some embodiments, the expansion mechanism is configured
to move the arms and the pads radially outwards from the device at
the constant force for a preset period of time. In some
embodiments, the preset period of time comprises 5-10 minutes. In
other embodiments, the preset period of time comprises 5-60
minutes. In additional embodiments, the preset period of time
comprises less than 2 hours.
[0050] In another embodiment, a vaginal dilation device is
provided, comprising a handle, a plurality of arms coupled to the
handle, each arm having a pad disposed thereon that is shaped and
configured to conform to a vagina, an expansion mechanism coupled
to the arms and configured to move the arms and the pads radially
outwards from the device, and a diameter sensor disposed on the
device and configured to measure a diameter of the device.
[0051] In some embodiments, each of the plurality of arms comprises
a scissor-like assembly coupled to each of the pads. The expansion
mechanism can be coupled to a central rod which is coupled to the
handle and the arms, wherein axial movement of the central rod
changes a distance of the pads from the central rod.
[0052] In one embodiment, actuation of the expansion mechanism is
configured to move the central rod proximally towards the handle to
move the arms and pads radially outwards from the central rod.
[0053] In some embodiments, the pads are arranged in a
substantially parallel configuration as the arms and pads move
radially outwards.
[0054] In some embodiments, the vaginal dilation device further
comprises a closed configuration wherein the pads are arranged
circumferentially around the central rod, and an expanded
configuration wherein the pads are extended away from the central
rod and away from adjacent pads. In one embodiment, an outer
diameter of the pads in the closed configuration is less than 4 cm.
In another embodiment, an outer diameter of the pads in the
expanded configuration is approximately 8-10 cm.
[0055] In one embodiment, the vaginal dilation device further
comprises a quick-release mechanism configured to quickly reduce an
outer diameter of the device. In some embodiments, the device
further comprises an actuation mechanism disposed on the handle
that is configured to engage the quick-release mechanism. In
another embodiment, the device further comprises a bump-release
disposed on a distal portion of the device that is configured to
engage the quick-release mechanism. In some embodiments, the
bump-release is configured to be engaged by a baby entering a
vaginal canal.
[0056] In some embodiments, a center of mass of the vaginal
dilation device shifts forward under the pads as the device is
expanded from the closed configuration to the expanded
configuration.
[0057] In some embodiments, the vaginal dilation device further
comprises a controller coupled to the expansion mechanism and the
diameter sensor, the controller configured to automatically move
the arms and the pads radially outwards based on the diameter
measured by the diameter sensor. For example, in some embodiments,
the diameter sensor can measure a diameter of the device, and the
controller can automatically expand or contract the device based on
the measured diameter. The controller can automatically increase
the diameter if the measured diameter is too low, or can
automatically decrease the diameter if the measured diameter is too
high.
[0058] In some embodiments, the vaginal dilation device further
comprises a motor coupled to the central rod and a controller
coupled to the diameter sensor and the motor, the controller
configured to automatically move the central rod axially, and the
arms and the pads radially outwards at a constant rate of dilation.
In some embodiments, the device further comprises a controller
coupled to the expansion mechanism and the diameter sensor, the
controller configured to automatically move the arms and the pads
radially outwards based on the diameter measured by the diameter
sensor.
[0059] Some embodiments of the vaginal dilation device further
comprise an expandable sheath disposed over the pads. Other
embodiments further comprise a working channel disposed on or in
the device.
[0060] Some embodiments of the vaginal dilation device further
comprise a clutching mechanism configured to prevent over-expansion
of the pads. Other embodiments further comprise an automatic
oscillation mechanism configured to prevent pressure necrosis.
[0061] In one embodiment of the vaginal dilation device, none of
the pads contact a urethra or any nerve bundles positioned along an
anterior portion of the vagina of the patient when the pads move
radially outwards from the device. In other embodiments, none of
the pads contact a perineum of the patient when the pads move
radially outwards from the device.
[0062] In some embodiments, the expansion mechanism is remotely
coupled to the arms via a flexible assembly.
[0063] In some embodiments, the constant rate of dilation is user
adjustable.
[0064] In some embodiments, the vaginal dilation device further
comprises a timer configured to alert a user to increase the
diameter of the device.
[0065] In one embodiment, the expansion mechanism comprises a
trigger assembly configured to expand the device by a preset
dilation increment with a single actuation of the trigger assembly.
In some embodiments, the preset dilation increment is user
adjustable.
[0066] A method of dilating a vagina during labor is provided,
comprising inserting a vaginal dilation device into the vagina,
measuring a force applied by the vaginal dilation device to the
vagina, and dilating the vagina with the vaginal dilation
device.
[0067] In some embodiments, the method further comprises pausing
dilation of the vagina with the vaginal dilation device when the
force applied by the vaginal dilation device to the vagina
increases to a first force threshold. In one embodiment, the method
further comprises resuming dilation of the vagina when the force
applied by the vaginal dilation device to the vagina decreases to a
second force threshold. In another embodiment, the resuming
dilation step further comprises resuming dilation of the vagina
with the vaginal dilation device until the force applied by the
vaginal dilation device increases to the first force threshold. In
one embodiment, the resuming dilation step further comprises
resuming dilation of the vagina with the vaginal dilation device
until the force applied by the vaginal dilation device increases to
a third force threshold, the third force threshold being larger
than the first force threshold. In one embodiment, the first force
threshold is larger than the second force threshold. In another
embodiment, the first force threshold is less than 8 lbs. of
force.
[0068] In some embodiments of the method, the inserting step
further comprises inserting the vaginal dilation device into the
vagina during a first phase of labor. The method can further
comprise removing the vaginal dilation device from the vagina prior
to a second phase of labor.
[0069] In some embodiments, the measuring a force step further
comprises measuring the force with the vaginal dilation device.
[0070] In one embodiment, the method further comprises measuring a
diameter of the vagina with the vaginal dilation device. The method
can further comprise dilating the vagina with the vaginal dilation
device based on the measured diameter.
[0071] In some embodiments, the dilating step further comprises
dilating the vagina at a constant force with the vaginal dilation
device. In other embodiments, the dilating step further comprises
manually dilating the vagina with the vaginal dilation device. In
an additional embodiment, the dilating step further comprises
automatically dilating the vagina with the vaginal dilation
device.
[0072] In another embodiment, the dilating step further comprises
dilating the vagina with the vaginal dilation device at a location
remote from the patient.
[0073] Another method of dilating a vagina during labor is
provided, comprising inserting a vaginal dilation device into the
vagina, and applying a constant force to the vagina with the
vaginal dilation device to dilate the vagina. In some embodiments,
the constant force is less than 8 lbs. of force. In other
embodiments, the constant force is adjustable.
[0074] In some embodiments of the method, the inserting step
further comprises inserting the vaginal dilation device into the
vagina during a first phase of labor. In other embodiments, the
method comprises removing the vaginal dilation device from the
vagina prior to a second phase of labor. In additional embodiments,
the method comprises removing the vaginal dilation device from the
vagina when the vagina is dilated to a diameter of approximately
8-10 cm.
[0075] In some embodiments, the method comprises measuring a
diameter of the vagina with the vaginal dilation device.
[0076] In another embodiment, the applying step further comprises
automatically applying a constant force to the vagina with the
vaginal dilation device to dilate the vagina. In one embodiment,
the applying step further comprises automatically applying the
constant force to the vagina with a constant force spring disposed
in the vaginal dilation device. In another embodiment, the applying
step further comprises automatically applying the constant force to
the vagina with an automated controller and a motor coupled to the
vaginal dilation device. In another embodiment, the applying step
further comprises applying the constant force to the vagina with
the vaginal dilation device for a preset period of time to dilate
the vagina. In some embodiments, the preset period of time
comprises less than 5 minutes. In other embodiments, the preset
period of time comprises 5-10 minutes. In additional embodiments,
the preset period of time comprises 5-60 minutes. In yet another
embodiment, the preset period of time comprises less than 2
hours.
[0077] Another embodiment of the method comprises measuring a force
applied by the vaginal dilation device to the vagina.
[0078] A method of preventing tissue damage during childbirth is
provided, comprising inserting a vaginal dilation device into a
patient's vagina during a first phase of labor, and dilating the
patient's vagina with the vaginal dilation device.
[0079] In some embodiments, the method further comprises removing
the vaginal dilation device from the patient's vagina prior to a
second phase of labor.
[0080] In another embodiment, the dilating step comprises dilating
the patient's vagina to approximately 7-10 cm with the vaginal
dilation device.
[0081] A vaginal exercise device is provided, comprising a handle,
a plurality of arms coupled to the handle, each arm having a pad
disposed thereon that is shaped and configured to conform to a
vagina, an expansion mechanism coupled to the arms and configured
to move the arms and the pads radially outwards from the device at
a user-specified force, and a force sensor disposed on the device
and configured to measure a force applied by the vagina against the
pads.
[0082] In some embodiments, axial movement of the expansion
mechanism engages a sloping interior cam surface of the pads to
expand the pads radially outward. In other embodiments, the
expansion mechanism comprises a cone shaped object.
[0083] In some embodiments, the expansion mechanism comprises a
plurality of living hinges.
[0084] In one embodiment, the expansion mechanism is coupled to a
central rod which is coupled to the handle and the arms, wherein
axial movement of the central rod changes a distance of the pads
from the central rod.
[0085] In some embodiments, actuation of the expansion mechanism is
configured to move the central rod proximally towards the handle to
move the arms and pads radially outwards from the central rod.
[0086] In some embodiments, the pads are arranged in a
substantially parallel configuration as the arms and pads move
radially outwards.
[0087] One embodiment further comprises a closed configuration
wherein the pads are arranged circumferentially around the central
rod, and an expanded configuration wherein the pads are extended
away from the central rod and away from adjacent pads. In one
embodiment, an outer diameter of the pads in the closed
configuration is less than 1 cm. In another embodiment, an outer
diameter of the pads in the expanded configuration is approximately
2-4 cm.
[0088] Some embodiments further comprise a diameter sensor
configured to indicate a dilation diameter of the vagina.
[0089] In one embodiment, the expansion mechanism is configured to
automatically move the arms and the pads of the device radially
outwards at the user-specified force. In another embodiment, the
expansion mechanism comprises a spring coupled to the central rod,
wherein the spring pushes against the central rod with a constant
force to move the arms and the pads radially outwards from the
central rod.
[0090] In some embodiments, none of the pads contact a urethra or
any nerve bundles positioned along an anterior portion of the
vagina of the patient when the pads move radially outwards from the
device.
[0091] In another embodiment, none of the pads contact a perineum
of the patient when the pads move radially outwards from the
device.
[0092] In one embodiment, the expansion mechanism is remotely
coupled to the arms via a flexible assembly.
[0093] A cervical dilation device is provided, comprising a handle,
a plurality of arms coupled to the handle, each arm having a pad
disposed thereon that is shaped and configured to conform to a
cervix of a patient, an expansion mechanism coupled to the arms and
configured to move the arms and the pads radially outwards from the
device at a constant force, a force sensor disposed on the device
and configured to measure a force applied against the pads, and an
extension mechanism coupling the handle to the arms and the
expansion mechanism, the extension mechanism sized and configured
to allow the arms to access the cervix while the handle remains
outside of the patient.
[0094] In some embodiments, the expansion mechanism is coupled to a
central rod which is coupled to the handle and the arms, wherein
axial movement of the central rod changes a distance of the pads
from the central rod.
[0095] In one embodiment, actuation of the expansion mechanism is
configured to move the central rod proximally towards the handle to
move the arms and pads radially outwards from the central rod.
[0096] In some embodiment, the pads are arranged in a substantially
parallel configuration as the arms and pads move radially
outwards.
[0097] Another embodiment of the device comprises a closed
configuration wherein the pads are arranged circumferentially
around the central rod, and an expanded configuration wherein the
pads are extended away from the central rod and away from adjacent
pads. In some embodiments, an outer diameter of the pads in the
closed configuration is less than 1 cm. In other embodiments, an
outer diameter of the pads in the expanded configuration is
approximately 2-10 cm.
[0098] Some embodiments of the device further include a diameter
sensor configured to indicate a dilation diameter of the
cervix.
[0099] In some embodiments, the expansion mechanism is configured
to automatically move the arms and the pads of the device radially
outwards at the constant force.
[0100] In other embodiments, the expansion mechanism comprises a
spring coupled to the central rod, wherein the spring pushes
against the central rod with the constant force to move the arms
and the pads radially outwards from the central rod.
[0101] In some embodiments, each of the plurality of arms comprises
a scissor-like assembly coupled to each of the pads.
[0102] Some embodiments further comprise a quick-release mechanism
configured to quickly reduce an outer diameter of the device.
[0103] In one embodiment, the device further comprises an actuation
mechanism disposed on the handle that is configured to engage the
quick-release.
[0104] Some embodiments further comprise a controller coupled to
the expansion mechanism and the force sensor, the controller
configured to automatically move the arms and the pads radially
outwards based on the force measured by the force sensor.
[0105] In one embodiment, the controller is configured to
automatically move the arms and the pads radially outwards to apply
the constant force with the pads.
[0106] Some embodiments further comprise a motor coupled to the
central rod and a controller coupled to the force sensor and the
motor, the controller configured to automatically move the central
rod axially, and the arms and the pads radially outwards, based on
the force measured by the force sensor.
[0107] In some embodiments, the controller is configured to
automatically move the central rod axially to apply the constant
force with the pads.
[0108] Some embodiments further comprise a controller coupled to
the expansion mechanism and the force sensor, the controller
configured to automatically move the arms and the pads radially
outwards until the force measured by the force sensor exceeds a
force threshold.
[0109] A method of dilating a cervix during labor is provided,
comprising inserting a cervical dilation device into the cervix,
measuring a force applied by the cervical dilation device to the
cervix, dilating the cervix with the cervical dilation device, and
pausing dilation of the cervix with the cervical dilation device
when the force applied by the cervical dilation device to the
cervix increases to a first force threshold.
[0110] In some embodiments the method comprises resuming dilation
of the cervix when the force applied by the cervical dilation
device to the cervix decreases to a second force threshold. In one
embodiment, the resuming dilation step further comprises resuming
dilation of the cervix with the cervical dilation device until the
force applied by the cervical dilation device increases to the
first force threshold. In another embodiment, the resuming dilation
step further comprises resuming dilation of the cervix with the
cervical dilation device until the force applied by the cervical
dilation device increases to a third force threshold, the third
force threshold being larger than the first force threshold.
[0111] In some embodiments, the first force threshold is larger
than the second force threshold. In other embodiments, the first
force threshold is less than 8 lbs. of force.
[0112] In some embodiments, the inserting step further comprises
inserting the cervical dilation device into the cervix during a
first phase of labor.
[0113] Some embodiments further comprise removing the cervical
dilation device from the cervix prior to a second phase of
labor.
[0114] In one embodiment, the measuring a force step further
comprises measuring the force with the cervical dilation
device.
[0115] Other embodiments of the method further comprise measuring a
diameter of the cervix with the vaginal dilation device.
[0116] Other embodiments of the method further comprise dilating
the cervix with the cervical dilation device based on the measured
diameter.
[0117] In some embodiments, the dilating step further comprises
dilating the cervix at a constant force with the cervical dilation
device. In additional embodiments, the dilating step further
comprises manually dilating the cervix with the cervical dilation
device. In another embodiment, the dilating step further comprises
automatically dilating the cervix with the cervical dilation
device. In another embodiment, the dilating step further comprises
dilating the cervix with the cervical dilation device at a location
remote from the patient.
[0118] A method of exercising pelvic muscles surrounding a vagina
is provided, comprising inserting a vaginal exercise device into
the vagina, applying a constant force to the vagina with the
vaginal exercise device, and measuring the force applied by the
vagina to the vaginal exercise device.
[0119] In some embodiments, the constant force is less than 8 lbs.
of force. In other embodiments, the constant force is user
adjustable.
[0120] In some embodiments, the vaginal exercise device expands
outwardly to a diameter of 2-4 cm.
[0121] In one embodiment, the applying step further comprises
automatically applying a constant force to the vagina with the
vaginal exercise device.
[0122] In another embodiment, the applying step further comprises
automatically applying the constant force to the vagina with a
constant force spring disposed in the vaginal exercise device.
[0123] In one embodiment, the applying step further comprises
automatically applying the constant force to the vagina with an
automated controller and a motor coupled to the vaginal exercise
device.
[0124] In some embodiments, the applying step further comprises
applying the constant force to the vagina with the vaginal exercise
device for a preset period of time to exercise the pelvic muscles
surrounding the vagina.
[0125] In some embodiments, the preset period of time comprises
less than 5 minutes, 5-10 minutes, 5-60 minutes, or less than 2
hours.
BRIEF DESCRIPTION OF THE DRAWINGS
[0126] FIGS. 1A-1D illustrate some embodiments of a vaginal
dilation device.
[0127] FIG. 2 is one view of a vaginal dilation device in an
expanded configuration.
[0128] FIGS. 3A-3D show cross-sectional views of a vaginal dilation
device.
[0129] FIGS. 4A-4B show cross-sectional views of an automated
vaginal dilation device.
[0130] FIGS. 5A-5D illustrate various embodiments of pad shapes for
use with a vaginal dilation device.
[0131] FIGS. 6A-6G illustrate various embodiments of force sensors
disposed on or in a vaginal dilation device.
[0132] FIGS. 7A-7B show embodiments of a vaginal dilation device
with a protective sheath.
[0133] FIGS. 8A-8D illustrate various embodiments of a vaginal
dilation device having working channels or through ports.
[0134] FIG. 9 illustrates a vaginal dilation device with a
quick-release mechanism.
[0135] FIGS. 10A-10B illustrate a vaginal dilation device with a
quick-release mechanism inserted into a female patient during
labor.
[0136] FIGS. 11-12 illustrate the female reproductive anatomy.
[0137] FIGS. 13A-13B illustrate a vaginal dilation device inserted
into a female patient in both a closed and expanded configuration,
respectively.
[0138] FIGS. 14A-14D illustrate a vaginal dilation device inserted
into a female patient during labor.
[0139] FIG. 15 is a chart illustrating one method of dilating
vaginal tissue during labor.
[0140] FIG. 16 is a chart illustrating another method of dilating
vaginal tissue during labor.
[0141] FIG. 17 is a chart illustrating another method of dilating
vaginal tissue during labor.
[0142] FIG. 18 is a chart illustrating an additional method of
dilating vaginal tissue during labor.
[0143] FIGS. 19A-19B illustrate yet another embodiment of a vaginal
dilation device.
[0144] FIGS. 20A-20D illustrate another embodiment of a vaginal
dilation device.
[0145] FIGS. 21A-21C illustrate another embodiment of a vaginal
dilation device.
[0146] FIGS. 22A-22E illustrate another embodiment of a vaginal
dilation device.
[0147] FIGS. 23A-23B illustrate another embodiment of a vaginal
dilation device.
[0148] FIGS. 24A-24C illustrate another embodiment of a vaginal
dilation device.
[0149] FIGS. 25A-25C illustrate another embodiment of a vaginal
dilation device.
[0150] FIGS. 26A-26C illustrate another embodiment of a vaginal
dilation device.
[0151] FIG. 27 illustrates another embodiment of a vaginal dilation
device.
[0152] FIG. 28 illustrates another embodiment of a vaginal dilation
device.
[0153] FIGS. 29A-29B illustrate another embodiment of a vaginal
dilation device.
[0154] FIG. 30 illustrates another embodiment of a vaginal dilation
device.
[0155] FIG. 31 illustrates another embodiment of a vaginal dilation
device.
[0156] FIG. 32 illustrates another embodiment of a vaginal dilation
device.
[0157] FIG. 33 illustrates another embodiment of a vaginal dilation
device or a vaginal exercise device.
[0158] FIGS. 34A-34B illustrate another embodiment of a vaginal
dilation device or a vaginal exercise device.
[0159] FIG. 35 illustrates another embodiment of a vaginal dilation
device or a vaginal exercise device.
[0160] FIG. 36 illustrates one embodiment of a cervical dilation
device.
DETAILED DESCRIPTION OF THE INVENTION
[0161] The devices and methods described herein are intended to
prepare and dilate vaginal tissue during labor so as to prevent
pelvic floor damage, and vaginal and perineal lacerations. Some
embodiments of the device can stretch the perineal tissue until the
diameter of the vaginal introitus has reached a target diameter of
approximately 10 cm, roughly the size of the fetal head. In some
embodiments, the device is a mechanical dilator that penetrates the
first 3-4 cm of the vagina, the introitus, and gradually expands
the vagina from a resting diameter of 2-3 cm to a fully expanded
diameter equal to the size of the delivering fetus, approximately
10 cm. Expansion can be controlled either manually or via an
automatic actuation system, and the device can be quickly collapsed
and removed if needed.
[0162] The devices described herein can be inserted during the
first phase of labor and removed just prior to the second phase of
labor, allowing the rest of the birthing process to proceed as
normal. The device is intended to be used prior to the second phase
of labor to prevent a baby from contacting the device during
delivery. Depending on how long it takes to achieve full vaginal
dilation to approximately 10 cm, the device can be inserted early
during the first phase of labor with only very minor amounts of
dilation. The dilation diameter target of 10 cm means that the
device should be used in a hospital under the supervision of
trained obstetricians and nurses. The device can be used without
any anesthesia, or under local anesthetic. The tissue can also be
prepared after administering an epidural, which would eliminate any
pain or discomfort the device may cause. Local anesthesia can also
be placed on the tissue contacting surfaces of the device to
minimize pain.
[0163] FIGS. 1A-1C illustrate one embodiment of a vaginal dilation
device 100. Vaginal dilation device 100 can include rigid or
semi-rigid pads 102, arms 104, handle 106, and expansion mechanism
108. In the embodiment of FIGS. 1A-1C, device 100 includes four
sets of pads 102 and arms 104. In other embodiments, any number of
pads and arms can be used. For example, one embodiment comprises as
few as 2 or 3 sets of pads and arms, and other embodiments can
include more than four sets of pads and arms, such as 5, 6, 7, or
even 8 or more sets of pads and arms. The sets of pads and arms can
be arranged symmetrically or asymmetrically around a central axis
of the device.
[0164] The pads 102 can be coupled to arms 104, which can be
coupled to a central rod (not shown) that extends along a
longitudinal axis of the device, through the handle 106, and is
coupled to expansion mechanism 108. The tissue contacting pads 102
can be designed to maintain stability through all dilation
diameters. In some embodiments, the pads can have a saddle shape
that maintains a constant waist size and pitch when expanded. These
pads can be overmolded with a very compliant biocompatible
elastomeric material to help evenly distribute force against the
tissue and prevent trauma. Additional pad shapes and designs will
be discussed below.
[0165] In the embodiment shown in FIGS. 1A-1C, arms 104 comprise a
scissor-like assembly, and include shafts 110 and 112 which rotate
around pivot 114. Shafts 110 and 112 can be coupled to the pads and
to the central rod. In FIGS. 1A-1C, expansion mechanism 108
comprises a mechanical knob configured to expand the arms of the
vaginal dilation device. Manual rotation of the knob can cause the
knob to move away from the handle and the central rod to move
proximally into the handle, allowing shafts 110 and 112 to rotate
around pivot 114 and push pads 102 radially outwards from the
central rod of the device. Since the arms 104 comprise a
scissor-like assembly, the pads 102 can remain parallel to the
device and to one another during expansion, which maintains the
orientation of the pads to the tissue stable during dilation.
Additionally, maintaining the pads in a parallel orientation can
help keep the device in place in the tissue while maximizing force
distribution along the pads.
[0166] Rotation of the knob in the opposite direction can cause the
central rod to move distally, causing the scissor-like assembly to
collapse and moving the pads inwards towards the central rod. In
some embodiments, the sets of arms 104 can have varying radii of
curvature, which can expand the arms out at different rates if
desired.
[0167] Although most embodiments described herein show the arms as
a scissor-like assembly, it should be understood that other methods
and apparatus for expanding the pads can be used. For example, the
arms can be singular arms attached to the pads (e.g., similar to a
speculum).
[0168] The vaginal dilation device can be sized, shaped, and
configured to penetrate approximately the first third, or 3-4 cm,
of the vagina, and to gradually expand the vaginal introitus from a
resting diameter of approximately 2 cm to a fully dilated diameter
of approximately 10 cm. The vaginal dilation device 100 can be
configured to expand from a compact, closed configuration, as shown
in FIG. 1A, to an expanded configuration, as shown in FIG. 1C. When
the device is in the closed configuration, the pads can be
seamlessly closed against each adjacent pad so as to form a solid
shape (e.g., circle, oval, etc.).
[0169] When the device is in the closed configuration of FIG. 1A,
pads 102 can be configured to rest against each adjacent pad so as
to reduce the outer diameter of the device. In some embodiments,
the diameter of the pads in the closed configuration can be less
than 4 cm. In one embodiment, the outer diameter of the pads in the
closed configuration is approximately 2-4 cm. In other embodiments,
the pads do not rest against adjacent pads in the closed
configuration, but this can result in the minimum outer diameter of
the pads being larger, or alternatively, in the individual pads 102
having a smaller surface area, which may lead to patient discomfort
during tissue dilation.
[0170] As the device dilates to the expanded configuration, as
shown in FIGS. 1B-1C, pads 102 and arms 104 move radially outwards
from the device, causing the pads to separate from one another. In
some embodiments, the maximum diameter of the pads in the expanded
configuration can be approximately 10 cm. In one embodiment, the
maximum outer diameter of the pads in the expanded configuration is
approximately 8-12 cm.
[0171] The vaginal dilation device 100 is specifically designed to
promote compactness, effective dilation, and good tissue contact
during expansion. As the device expands from the closed
configuration to the expanded configuration, the center of mass of
the device can move under the pads, as shown by arrow 116 in FIG.
1C, which helps keep the device in place without rotating and
falling out of the vagina.
[0172] The vaginal dilation device 100 can further comprise
indicator(s) or gauge(s) 118. In the embodiment of FIGS. 1A-1C, the
gauge 118 is disposed on handle 106, however the gauge can be
disposed in any location on the device, or even remotely from the
device such as on a display monitor. In some embodiments, the gauge
gives the user an indication of the diameter of the pads 102. A
user, such as a physician, can then use the gauge to know the exact
amount of tissue dilation. Gauge 118 can comprise a simple binary
readout (showing the diameter is above or below some threshold to
continue dilating), or can have a scale showing the actual diameter
of the device, for example.
[0173] In other embodiments, the vaginal dilation device 100
includes force sensors (not shown) configured to measure a force
applied by the pads against tissue, or alternatively, to measure a
force applied against the pads, and the gauge 118 can give the user
an indication of the measured force. The force sensors can be
strain gauges, whetstone bridges, piezoelectric crystals,
hydraulic/pneumatic load cells, elastic devices, or any other force
sensor or force transducer known in the art. Gauge 118 can comprise
a simple binary readout (showing the force is above or below some
threshold to continue dilating), or can have a scale showing the
actual force being applied to the tissue, for example. In
additional embodiments, gauge 118 can indicate both a diameter of
the pads and a force sensed by the pads. Alternatively, the vaginal
dilation device can comprise multiple gauges, including diameter
gauges and force gauges.
[0174] The dilation device may additionally include a quick-release
mechanism configured to collapse the device from the expanded
configuration to the closed configuration. The quick-release
mechanism can comprise bump-release 120 and quick-release lever
122. Additional details regarding the quick-release mechanism will
be discussed below.
[0175] FIG. 1D illustrates one embodiment similar to the device of
FIGS. 1A-1C, however the expansion mechanism 108 of FIG. 1D
remotely coupled to the rest of the device (e.g., remotely coupled
to the central shaft, arms, and pads) via flexible assembly or
flexible tube 109. The device of FIG. 1D operates in the same
manner as the device described above in FIGS. 1A-1C, however the
remote expansion mechanism allows a user to expand/dilate the
device from a distance away from the patient. This is advantageous
because during labor, the patient's legs are typically covered with
sheets or a blanket, so the remote expansion mechanism allows for
actuation of the device without having to remove the covers,
protecting the patient's privacy.
[0176] In other embodiments, the device can include an alarm or
alert mechanism, such as a visual alert (e.g., a light, or a
warning indicator on a display) or an audible alert (e.g., a buzzer
or an alarm sound) to indicate to a user that the device is
applying too much, or too little force to the vagina. The alert
mechanism can also include a timer configured to alert the user
(e.g., by an audible or visual signal) when to dilate the
device.
[0177] FIG. 2 is a cutaway view of a vaginal dilation device 200 in
an expanded configuration, showing the operation of a diameter
gauge 218 according to one embodiment. Vaginal dilation device 200
is a variation of the vaginal dilation device 100 described above.
FIG. 2 illustrates the interior of handle 206, including expansion
mechanism 208, diameter gauge 218, central rod 224, spring 226, and
nut 228. Rotation of the expansion mechanism can cause central rod
224 to move proximally into the handle, which in turn causes nut
228 to move proximally to compress spring 226. As the spring is
compressed, it can apply pressure to the diameter gauge 218,
causing it to move according to the diameter of the pads 202 and
arms 204 as they expand radially outwards. Since the outward
movement of a scissor-like mechanism as shown in FIG. 2 is not
linear, the vaginal dilation device may further include a diameter
gauge amplifying mechanism 230, such as an additional spring
coupled to a rotating portion of the gauge, to provide a more
linear read out for the diameter gauge 218.
[0178] The tip of gauge 218 may extend out through a window in the
handle 206. In some embodiments, the handle can include indicator
marks or diameter measurements along the length of the window to
provide an indication to the user of the diameter of the device.
The marks can be colors, such as green, yellow, red, to give an
indication of the amount of dilation, or can be accurate diameter
measurements, such as marks indicating 0-10 cm of dilation. Other
marks or indicators can also be used, as long as they give an
approximate or accurate read-out of the diameter of the device as
it expands.
[0179] FIGS. 3A-3B show cross-sectional views of another embodiment
of a vaginal dilation device 300. The vaginal dilation devices
described above in FIGS. 1 and 2 were directed to a device actuated
by manual rotation of a knob. However, the vaginal dilation device
300 of FIGS. 3A-3B can include an actuation mechanism that
comprises a constant force device 332 and a button 336 to actuate
expansion of the device. In the embodiment shown in FIGS. 3A-3B,
the constant force device 332 comprises a spring. However, any
similar stored energy device can be used in place of the spring,
including a pump or a piston, an elastic band, or gears, for
example.
[0180] The vaginal dilation device of FIGS. 3A-3B can include arms
304, handle 306, gauge 318, central rod 324, shuttle assembly 325,
rack assembly 334, button 336, and pad supports 340. In the
embodiment of FIGS. 3A-3B, button 336 can be coupled to a pin 338.
Pad supports are configured to support pads, such as pads 102 or
202 described above. It should be understood that button 336 could
be any other form of actuating device, such as a lever, a trigger,
or a rotating dial, for example.
[0181] Referring still to FIGS. 3A-3B, the operation of vaginal
dilation device 300 will now be described. As shown, arms 304 can
comprise a scissor-like assembly. A proximal portion of the
scissor-like assemblies can be coupled to the handle 306, and a
distal portion of the scissor-like assemblies can be coupled to
shuttle assembly 325. Central rod 324 can extend from shuttle
assembly 325 along a longitudinal axis of the device into handle
306, terminating at rack assembly 334. Constant force device 332,
such as a spring, can be disposed inside the handle around the
central rod, compressed between an inner wall of the handle and the
rack assembly. The rack assembly can comprise a plurality of gears
or teeth, which can engage pin 338 of button 336.
[0182] When button 336 is depressed, pin 338 disengages rack
assembly 334. Constant force device 332 (e.g., a spring) is then
allowed to decompress and expand, thereby applying a constant force
against the rack assembly and the central rod 324, and thus shuttle
assembly 325, proximally towards handle 306. As the distance
between shuttle assembly 325 and handle 306 decreases, the
scissor-like assemblies expand, pushing pad supports and pads (not
shown) radially outward from the device. It should also be
understood that device 300 of FIGS. 3A-3B can comprise an actuation
mechanism remotely coupled to the device (e.g., via a flexible tube
as shown in FIG. 1D) so as to allow for expansion of the device
from a location remote from or a distance away from the
patient.
[0183] As the constant force device 332 pushes against rack
assembly 334 and central rod 324, gauge 318 moves proximally with
the rack assembly, giving the user an indication of the dilation
diameter of the pads of the vaginal dilation device. Expansion of
the device continues until the next tooth or gear in the rack
assembly engages pin 338 of button 336. The teeth of rack assembly
334 can be spaced at specific increments of dilation, for example,
spaced 1 cm apart along the desired range of dilation, such as from
1 cm to 10 cm. Once the rack assembly has re-engaged pin 338, the
user can again depress button 336 to initiate the next interval of
dilation. In some embodiments, the button can also remain in the
pushed "on" position, which would allow the device to continue
expanding and dilating tissue with a constant force. Similarly, in
another embodiment, the rack assembly can include only a single
tooth or gear, allowing the device to continue to expand at a
constant force once the pin 338 has disengaged the single
tooth.
[0184] Since the vaginal dilation device is configured to expand at
a constant force, the amount of force applied by the device to
tissue can be determined and controlled so as to maximize
effectiveness of the device and prevent the device itself from
causing tissue damage. The constant force can be set at a level to
reduce the risk of causing trauma, yet be enough to successfully,
controllably dilate the tissue. In another embodiment, the vaginal
dilation device can include a clutching mechanism, such as another
spring or a torque-wrench type mechanism to prevent over-expansion
of the pads. The clutching mechanism can be configured to engage at
a preset force threshold to prevent the device from applying a
force higher than the force threshold to tissue. In other
embodiments, the device can include an alarm or alert mechanism,
such as a visual alert (e.g., a light, or a warning indicator on a
display) or an audible alert (e.g., a buzzer or an alarm sound) to
indicate to a user that the device is applying too much, or too
little force to the vagina. The alert mechanism can also include a
timer configured to alert the user (e.g., by an audible or visual
signal) when to dilate the device.
[0185] As described above, the constant force device 332 can
comprise any device configured to apply a constant force, such as a
spring, a piston, or a pump. The constant force device can be
configured to automatically apply a constant force of any desired
amount from the pads of the device to tissue. In some embodiments,
the constant force device can apply a constant force to tissue
ranging from approximately less than 10 lbs. of force. In some
embodiments where a spring is used as the constant force device,
the spring coils can have a variable thickness in order to adjust
for gains in mechanical advantage as the vaginal dilation device is
expanded, thus keeping the force applied by the device to tissue as
a constant.
[0186] FIGS. 3A-3B also illustrate the mechanisms that allow the
pads and pad supports 340 to remain parallel as the device expands.
Arms 304 can include a rotating pivot point 342 configured to slide
in slot 343 as the device expands. Movement of the pivot point
along the slot allows the pads to remain parallel to the central
rod of the device during tissue dilation.
[0187] FIGS. 20A-20D illustrate another embodiment of a mechanism
configured to allow pads 2002 to remain parallel as device 2000
expands. Referring to FIGS. 20A-20C, pads 2002 can connect to arms
2004 at pivot 2006. Spring 2008 can be configured to push against
pads 2002. As the device 200 expands, the load against the pads
increases, compressing the spring. The spring can be configured to
provide enough force to overcome any initial load applied against
the pads by the tissue. Thus, the spring can be chosen that has a
rate to allow the pads to remain parallel as the device expands.
FIG. 20D illustrates the device in an expanded configuration, with
the springs 2008 pushing against pads 2002 to cause the pads to
remain parallel. The device illustrated in FIGS. 20A-20D can be
configured for use as a vaginal dilator device or as a vaginal
exercise device.
[0188] In another embodiment, as shown in FIGS. 3C-3D, the vaginal
dilation device comprises a constant force mechanism 332, such as
the spring described above, and further includes a force adjustment
mechanism 344 configured to change the amount of force that the
constant force mechanism, and thus the vaginal dilation device,
applies to tissue. As shown in FIGS. 3C-3D, the force adjustment
mechanism 344 can comprise a wheel or knob positioned adjacent to
the spring. When the force adjustment mechanism is adjusted from a
minimum position, as shown in FIG. 3C, to a tensioned position, as
shown in FIG. 3D, the force adjustment mechanism compresses the
spring, and adds force to which the spring will push back against
the rack mechanism, thereby increasing the force the vaginal
dilation device can apply to tissue.
[0189] In some embodiments, the vaginal dilation device of FIGS.
3A-3D can include a dampener (not shown), to limit any rapid
dilation caused by the device. The dampener can be a piece of foam,
a spring, or a piston mechanism at the proximal end of the device,
for example.
[0190] FIG. 21A-21C illustrate another embodiment of a vaginal
dilation device 2100, including a cam 2102 configured to normalize
the force curve of arms 2104 as they expand. Certain features of a
vaginal dilation device not illustrated in FIGS. 21A-21C can be
found in other illustrations of vaginal devices described herein,
specifically FIGS. 1-3. Referring to FIG. 21A, vaginal dilation
device 2100 can include arms 2104 (e.g., a scissor-like mechanism)
coupled to central rod 2106 and shuttle assembly 2108. Cam 2102 can
be coupled to the central rod, and can be in contact with wheel
2110. The device can further include a constant force device (not
shown in FIG. 21A) similar in function and operation to constant
force device 332 described above in FIGS. 3A-3D. As the constant
force device pulls central rod 2106 and shuttle assembly 2108 in
the direction indicated by arrow 2112 to expand device 2100, cam
2102 pivots along wheel 2110. In a vaginal dilation device
utilizing a scissor-like expansion mechanism, the device requires
more force to expand at the beginning of expansion than at the end
of expansion (e.g., the vaginal dilation device requires more force
to expand from 1 cm to 2 cm than it does to expand from 9 cm to 10
cm). This is because a scissor-like expansion mechanism gains
mechanical advantage during expansion. The cam 2102 of FIGS.
21A-21C can be configured to linearize the force of vaginal
dilation device 2100 during expansion. To do so, the cam 2102 can
be designed to lose mechanical advantage at the same rate that the
scissor-like arms 2104 gain mechanical advantage during expansion.
For example, in one embodiment, a particular angular change in the
cam 2102 can lead to a corresponding change in diameter of the pads
and arms 2104 of the dilation device 2100.
[0191] FIG. 21B illustrates a cam 2102 comprising a diameter gauge
2114, wherein the diameter gauge is configured to display a
diameter of the vaginal dilation device. FIG. 21C illustrates
another embodiment of a cam 2102 including mechanical stops, rests,
or detents to provide feedback during the expansion process. In one
embodiment, shown in FIG. 21 C, stops can be placed along the cam
2102 corresponding to a pre-set device diameter. Thus, in FIG. 21C,
the stops are located at centimeter intervals ranging from 3 cm-10
cm (e.g., a stop is placed at positions on the cam corresponding to
device expansion diameters of 3 cm, 4 cm, 5 cm . . . 10 cm). In
some embodiments, the stops on cam 2102 can prevent the vaginal
dilation device from over-expanding without input from a user.
[0192] FIGS. 22A-22E illustrate additional embodiments for
overcoming low angle forces of a scissor-like expansion mechanism
in a vaginal dilation device 2200. Certain features of a vaginal
dilation device not illustrated in FIGS. 22A-22C can be found in
other illustrations of vaginal devices described herein,
specifically FIGS. 1-3. In the embodiment of FIGS. 22A-22C, lever
2202 can be pivotably coupled to central rod 2206, and the lever
can be configured to engage a detent or bump 2208 on arm 2204. As
the dilation device expands and central rod 2206 moves towards a
proximal end of the device, lever 2202 provides additional
mechanical advantage to arms 2204 because it is at a greater angle
relative to the central rod than the arms of the device. FIG. 22B
illustrates the lever 2202 fully expanded as the dilation device
and arms 2204 continue to expand. Referring now to FIG. 22C, the
arms 2204 of the dilation device have expanded beyond the point of
lever 2202 engaging detent 2208, so that the lever floats freely
and the arms are allowed to expand on their own. The lever can
continue to float until the arms collapse back to a point at which
the lever can once again engage the detent 2208.
[0193] FIGS. 22D-22E illustrate a similar concept to the device
illustrated in FIGS. 22A-22C. Certain features of a vaginal
dilation device not illustrated in FIGS. 22D-21E can be found in
other illustrations of vaginal devices described herein,
specifically FIGS. 1-3. In FIGS. 22D-22E, the central rod 2206 can
include a detent or bump 2202 instead of a lever, and the detent
2202 can be configured to engage a corresponding detent or bump
2208 on the arms 2204. This interaction between the detents 2202
and 2208 provides additional mechanical advantage to arms 2204
during the initial stages of expansion. Once the arms are
sufficiently expanded to the point where the detents are not
contacting another, as shown in FIG. 22D, the scissor-like
mechanism can continue to expand like normal.
[0194] FIGS. 23A-B illustrate another embodiment of a vaginal
dilation device 2300 comprising an adjustable force mechanism.
Certain features of a vaginal dilation device not illustrated in
FIGS. 23A-23B can be found in other illustrations of vaginal
devices described herein, specifically FIGS. 1-3. Referring to FIG.
23A, dilation device 2300 comprises force mechanism 2302 (e.g., a
spring), arms 2304, central rod 2306, force adjustment mechanism
2308, target diameter gauge 2310, and actual diameter gauge 2312.
The device can operate in a manner similar to the device described
herein, namely, the force mechanism 2302 pulls against central rod
2306, which causes arms 2304 to expand outward and increase the
diameter of the device. In the embodiment shown in FIG. 23A, force
adjustment mechanism 2308 can be used to change the compression of
force mechanism 2302. In some embodiments, force mechanism 2308 is
coupled to a target diameter gauge 2310, which is configured to
display a target diameter of dilation based on the current
compression setting of force mechanism 2302. Actual diameter gauge
2312 can be configured to display the actual dilation diameter of
the device. For example, if the vaginal dilation device 2300 is
inserted into a patient, and has achieved a maximum dilation for
that particular force setting, a user can adjust the force setting
of force mechanism 2302 with adjustment mechanism 2308 to increase
or decrease the diameter of the device. The desired diameter can be
dialed in according to target diameter gauge 2310, and the user can
monitor the progress of the device with actual diameter gauge
2312.
[0195] FIG. 23B is another embodiment of an adjustable force
mechanism for use with a vaginal dilation device. Certain features
of a vaginal dilation device not illustrated in FIG. 23B can be
found in other illustrations of vaginal devices described herein,
specifically FIGS. 1-3. Instead of changing the compression of a
force mechanism (e.g., a spring) as in the embodiment of FIG. 23A,
in this embodiment, force mechanism 2302 can be translated up and
down lever 2314 by rotating adjustment mechanism 2308. Adjusting
the location of the force mechanism along the lever acts like
changing the point of a fulcrum on a lever, which can adjust the
amount of force the force mechanism applies to the device. Thus, a
user can monitor the actual diameter gauge (not shown) and the
force gauge 2310, and adjust the position of the force mechanism
according to a desired diameter or force of the device.
[0196] FIGS. 24A-24C illustrate another embodiment of a vaginal
dilation device 2400, including a ratcheted cam 2403. Certain
features of a vaginal dilation device not illustrated in FIGS.
24A-24C can be found in other illustrations of vaginal devices
described herein, specifically FIGS. 1-3. Similar to the
embodiments described above that employ a cam, the ratcheted cam of
this embodiment can linearize the force needed to expand the
device. In this embodiment, force mechanism 2402 can push against
rack 2410, which engages ratcheted cam 2403. This causes central
rode 2406 to move proximally towards the ratcheted cam, which
expands arms 2404 and dilates the device outwardly. Force
adjustment mechanism 2408 can be configured to change the
compression of force mechanism 2402, as described above.
[0197] FIGS. 24B-C illustrate additional ways of adjusting the
force applied by the device, similar to the embodiment described
above in FIG. 23B. In FIG. 24B, force adjustment mechanism 2408 can
be configured to adjust a pivot point 2412 of the device. The pivot
point can then be connected to the central rod (not shown, but
described above) to facilitate expansion of the device. In FIG.
24C, the pivot point 2412 is fixed, so the force adjustment
mechanism 2408 is configured to adjust the position of the force
mechanism 2402 relative to the pivot point (similar to the fulcrum
embodiment described above in FIG. 23 B).
[0198] FIGS. 25A-25C illustrate another embodiment of a vaginal
dilation device comprising a ratcheted cam with multiple gears.
Certain features of a vaginal dilation device not illustrated in
FIGS. 25A-25C can be found in other illustrations of vaginal
devices described herein, specifically FIGS. 1-3. Similar to the
embodiment of FIGS. 24A-24C, force mechanism 2502 can be configured
to apply pressure to rack 2510, which engages ratcheted cam 2510 of
the device, causing scissor-like arms (not shown) to expand
outwardly from a central rod of the device. In this embodiment, the
ratcheted cam can include multiple gears, such as gears 2503a and
2503b having varying diameters. Referring to the side views of cam
2503 and rack 2510 in FIG. 25C, it can be seen that rack 2510 can
include multiple levels configured to align with the various gears
of the ratcheted cam. Using multiple gears allows a user to change
the amount of force applied to the arms of the device. For example,
smaller gear 2503b requires more force to expand the arms of the
dilation device than larger gear 2503a. Engaging the different
gears can be implemented in a number of ways. In one embodiment,
the ratcheted cam 2503 can be pushed laterally (e.g., in the
direction of arrow 2512) to change from smaller gear 2503b to
larger gear 2503a. Although the embodiment of FIGS. 25A-25C
illustrates only two gears, it should be understood that any number
of gears can be used.
[0199] FIGS. 26A-26C illustrate various embodiments of a constant
force spring that can be used in a vaginal dilation device. Certain
features of a vaginal dilation device not illustrated in FIGS.
26A-26C can be found in other illustrations of vaginal devices
described herein, specifically FIGS. 1-3. The constant force spring
illustrated in FIGS. 26A-26C can be used, for example, as the
constant force mechanism 332 of FIGS. 3C-3D above. FIG. 26A
illustrates back, side, and front views, respectively, of a
constant force mechanism 2632, comprising a cam 2603, a clock
spring 2602, a target diameter gauge 2608, and a dial 2610. Ratchet
features disposed on the dial (not shown) can prevent the dial from
unwinding. The spring would then be configured to transmit force
from the cam 2603 through a central rod (not shown, but similar in
function to the central rods described above), which would then
expand arms of the vaginal dilation device. The embodiment of FIG.
26A could also include an actual diameter gauge (not shown) in
addition to the target diameter gauge.
[0200] FIGS. 26B-26C illustrate various embodiments for adjusting
the force of the clock spring 2602 of FIG. 26A. In FIG. 26B, force
adjustment mechanism 2612 can adjust a pivot point of lever 2614,
which changes the compression of clock spring 2602. In FIG. 26C,
force adjustment mechanism 2612 compresses the spring directly,
causing an increase or decrease in the force applied by the spring
to the cam.
[0201] FIG. 27 illustrates another embodiment of a constant force
vaginal dilation device 2700. In FIG. 27, the vaginal dilation
device includes a series of cylinders 2702a-d slidably connected to
central rod 2706. The cylinders can be separated by compression
springs 2704a-d. Flexible arch features 2706a-b (e.g., leaf
springs, living hinges) can also span from one cylinder to the
next. When the system is compressed, the arches bend and the device
expands in diameter. A dial feature 2708 can house a hard stop 2710
for each cylinder (only one hard stop is illustrated in FIG. 27).
Engaging a particular hard stop on the dial locks out a
corresponding spring(s). The force required to compress the system
becomes greater with each spring that is locked out. As shown in
the front view of dial 2708 in FIG. 27, the dial can include a
number of user actuatable hard stops corresponding to various
springs, and thus, various forces. For example, in one embodiment,
the dial includes force settings of 1 lb., 2 lbs., 3 lbs., and 4
lbs., corresponding to actuating each of the hard stops 2710. It
should be understood that other forces and number of hard
stops/springs can be used in other embodiments.
[0202] FIG. 28 illustrates another embodiment of a vaginal dilation
device 2800, comprising a stent or yurt-like design. In FIG. 28,
the device can comprise a plurality of scissor-like stent features
2802 that are pre-biased to expand. When the device is inserted
into tissue, for example into the vagina, the stent features can
automatically expand to cause the device to increase in diameter.
In some embodiments, the stent features 2802 comprise a shape
memory material, such as nitinol. The stent features can be
configured to expand at a preset force, depending on the
application and the maximum diameter desired. In some embodiments,
the device can include a diameter gauge 2804 configured to display
a diameter of the device. The device of FIG. 28 provides open
access to the interior of the device, allowing a physician or user
to gain access to the body cavity being dilated.
[0203] FIGS. 29A-29B illustrate another embodiment of a vaginal
dilation device 2900, utilizing a simplified expansion mechanism to
replace the scissor-like mechanisms described above. In FIG. 29A, a
force mechanism 2902 (e.g., a spring) can apply a force to arm
2904, which pivots against central rod 2906. Arm 2904 can also
pivotably connect to V-shaped mechanism 2908, which also pivots
against the central rod. As the spring expands and applies force
against arm 2904, it pivots against the central rod and expands
V-shaped mechanism 2908. Expansion of the arm 2904 and V-shaped
mechanism can cause the vaginal dilation device to expand, for
example, by pushing pads 2910 outward. FIG. 29B illustrates how
adjustment of dial 2912 in either direction can cause the spring to
shuttle in both directions along the central arm, thereby adjusting
the force applied by the force mechanism to the arm.
[0204] FIG. 30 illustrates yet another embodiment of a vaginal
dilation device 3000, including a simplified expansion mechanism.
The embodiment of FIG. 30 includes a rotating array 3002 comprising
a plurality of spring plungers 3004. In some embodiments, each
spring plunger applies a different force to a surface 3006 of the
device. For example, referring to FIG. 30, each of the four spring
plungers 3004 can have a different strength spring to apply a
different force to the device. The rotating array can be rotated to
change which spring plunger comes into contact with the surface of
the device. As shown in FIG. 30, the spring plungers can have
varying thicknesses to determine how much force is exerted by the
spring. When the spring plunger exerts a force against surface
3006, the device can pivot at pivot point 3008, allowing pads 3010
to expand outwards from the device to dilate tissue.
[0205] FIGS. 4A-4B show cross-sectional views of an automated
vaginal dilation device 400. In contrast to the manual or
semi-automated devices above, vaginal dilation device 400 can
comprise a semi-automated or fully-automated actuation mechanism
408 comprising a controller 448 coupled to a motor 454 within the
device and configured to automatically dilate, expand, and contract
the pads and arms. Automated vaginal dilation device 400 can
comprise pads 402, arms 404, handle 406, diameter sensor 418,
central rod 424, force sensors 446, controller 448, receiver 450,
transmitter 452, motor 454, and worm gear 456. Pads 402 and arms
404 move mechanically in a manner similar to that described above
in FIGS. 1-3.
[0206] In FIGS. 4A-4B, controller 448 (e.g., a computer comprising
hardware and software configured) can communicate with vaginal
dilation device either wirelessly, via receiver 450 and transmitter
452, or by wire (not shown). The vaginal dilation device can
measure a force applied by pads 402 to tissue, or alternatively,
can measure a force applied against the pads, and transmit the
measured force to controller 448 (e.g., either wirelessly or by
wire). The controller 448 can be configured to automatically move
the arms 404 and the pads 402 radially outwards based on the force
measured by the force sensor.
[0207] For example, hardware and software installed in controller
can drive motor 454 based on the measured force. Motor 454 can
include a threaded shaft 455, which can engage a rack assembly
disposed on central rod 424. When the motor 454 is actuated by
controller 448, the threaded shaft 455 can control movement of the
central rod, causing the arms and pads to expand and contract away
and towards the central rod of the device. In some embodiments,
motor 454 can be replaced with a pump or a computer actuated
piston, for example.
[0208] Motor 454 can also be attached to a second threaded shaft
456, which can engage gears on diameter sensor 418. As the motor
actuates the vaginal dilation device to expand or contract, the
second threaded shaft can engage and rotate sensor 418 to indicate
the diameter of the device. The measured diameter of the device can
also be transmitted to controller 448 as an analog or digital
signal (e.g., either wirelessly or by wire).
[0209] In other embodiments, the vaginal dilation device can
include an alarm or alert mechanism, such as a visual alert (e.g.,
a light, or a warning indicator on a display) or an audible alert
(e.g., a buzzer or an alarm sound) to indicate to a user that the
device is applying too much, or too little force to the vagina. The
alert mechanism can also include a timer configured to alert the
user or the controller (e.g., by an audible or visual signal or by
an input to the controller) when to dilate the device.
[0210] Many modes of operation are possible with the vaginal
dilation device shown in FIGS. 4A-4B. For example, controller 448
can be configured to actuate motor 454 to dilate the device
outwards at a constant force (e.g., a predetermined constant of
approximately less than 10 lbs. of force). In another embodiment,
the controller 448 can be configured to actuate motor 454 to dilate
the device outwards at a time-varying force. For example, the
controller can be configured to actuate motor 454 to dilate the
device until the force applied by the device to tissue approaches a
force threshold.
[0211] In another embodiment, a physician may initially want to
dilate the vaginal tissue at a first constant force. The first
constant force may be low, such less than 3 lbs. of force. After a
set period of time has passed, the controller can be configured to
automatically stop dilating tissue until receiving more
instructions from the user, or alternatively, the controller can be
configured to automatically dilate the vaginal tissue at a second
constant force. The second constant force may be different than the
first constant force, such as approximately 3-5 lbs. of force. In
this embodiment, the vaginal dilation device 400 can automatically
dilate tissue at a constant force for a set period of time, and
then can either stop dilating tissue or continue to dilate at a
second constant force. The controller can be configured to
automatically adjust the force applied by the device to the tissue
(e.g., either raise or lower the constant force) until the device
achieves the desired amount of tissue dilation (e.g., 10 cm of
dilation).
[0212] In another embodiment, the vaginal dilation device does not
automatically dilate for a set period of time, but rather, the
vaginal dilation device is configured to automatically expand and
dilate tissue until a threshold force is reached (as measured by
sensors 446). For example, a physician or the controller may set a
threshold force of approximately 3 lbs. of force. The vaginal
dilation device can then be configured to automatically dilate
vaginal tissue until sensors 446 measure a force greater than or
equal to the threshold force of 3 lbs. of force, at which point the
device would automatically stop dilating the tissue. It should be
understood that in other embodiments, the threshold force can be
any force and is not limited to 3 lbs.
[0213] In yet another embodiment, the controller can be configured
to actuate the vaginal dilation device to expand until a threshold
force is measured, and the controller can automatically actuate the
device to contract slightly upon reaching the threshold force so as
to allow the vaginal tissues to relax, and thus allow the force
applied by the device to the tissue to decrease.
[0214] In yet an additional embodiment, the controller can be
configured to actuate the vaginal dilation device based on a sensed
diameter of the device, or alternatively, based on a sensed force
and a sensed diameter of the device. The diameter can be measured
or sensed with diameter sensor 418. In some embodiments, the
controller can be configured to dilate the device until the device
reaches a preset diameter. In other embodiments, the controller can
be configured to actuate the device at a first force until the
device reaches a first diameter, and then to actuate the device at
a second force until the device reaches a second diameter. For
example, the controller can actuate the device at a force of 3 lbs.
until the device reaches a diameter of 3 cm. Upon dilating to 3 cm,
the controller can then automatically actuate the device at a force
of 4 lbs. until the device reaches a diameter of 4 cm. This process
of varying the force applied until preset diameters are reached can
be continued until the target dilation diameter is achieved.
[0215] FIG. 31 illustrates another embodiment of a vaginal dilation
device 3100, comprising a cam and a motor configured to
automatically oscillate the device. Certain features of a vaginal
dilation device not illustrated in FIG. 31 can be found in other
illustrations of vaginal devices described herein, specifically
FIGS. 1-3. The device functions similar to the cammed vaginal
dilation device of FIGS. 21A-21C. In operation, motor 3102 can
include an offset wheel which rotates against cam 3104, causing the
arms (not shown) and pads (not shown) of the vaginal dilation
device to oscillate. The arms and pads, and thus the device, can
then oscillate radially inward and outward as described herein in
other embodiments, either to promote tissue relaxation and dilation
or to prevent pain.
[0216] FIG. 32 describes another embodiment of a vaginal dilation
device 3200 utilizing a motor 3202 and a barrel cam 3204 to
normalize a force curve of the device as it expands. Certain
features of a vaginal dilation device not illustrated in FIGS. 32
can be found in other illustrations of vaginal devices described
herein, specifically FIGS. 1-4. A barrel cam with a variable pitch
groove can compensate for the varying force curve found in devices
with a scissor-like expansion mechanism 3203. The pitch of the cam
groove can be high at the start of a device expansion and decrease
as the device progresses towards full expansion at the end. This
means the barrel cam would lose mechanical advantage at the same
rate the scissor mechanism gains it.
[0217] A motor driving the barrel cam would see a constant load.
Adding a clutch 3206 with adjustable preload 3208 between the motor
and barrel cam would allow the user to control how much force is
transmitted to the scissor mechanism. The clutch could act as a
failsafe, preventing the device from "running away" and opening
uncontrollably. In some embodiments, irregularities or "bumps"
could be added to the cam groove to cause the scissor mechanism to
oscillate during expansion.
[0218] FIGS. 5A-5D illustrate various embodiments of pad shapes for
use with a vaginal dilation device. The pads described herein can
be covered by a soft atraumatic material made of a foam, silicone,
or other rubber or gel like material. Pads 502 typically have a
"saddle" shape, wherein both the distal and proximal portions of
the pads are raised so as to cradle and conform to the vaginal
tissue. The distal or anterior curve may better conform to the
natural shape of the anatomy in order to more effectively
distribute the force and provide greater stability. The proximal or
posterior curve can resemble a "heel" shape to help keep the device
from sliding out of the patient. As the vaginal dilation device
expands and engages tissue, the tissue may slide slightly on the
pad. However, the contacting surface of the introitus will remain
in the "valley" of the pads. In some embodiments, such as those
shown in FIGS. 5B-5C, the pads can include notches or raise
portions in an intermediate area of the pad to further conform to
or engage the anatomy. In other embodiments, the pads may include
slits to avoid putting pressure on the anterior or posterior
anatomy.
[0219] In additional embodiments, springs can be incorporated into
or below the pads. These springs can keep the force of the pad on
the tissue within a particular range to keep a user from over
dilating the device. For example, springs incorporated into or
below the pads may apply a constant force against the pads, similar
to the constant force device described above in FIG. 3. In yet an
additional embodiment, the device or the pads may further include
an automatic oscillation mechanism configured to prevent pressure
necrosis. For example, springs or other similar devices on or under
the pads can be configured to automatically oscillate to reduce
pressure applied to the tissue. In addition, the pads can include
heating or vibrating elements to increase tissue relaxation.
[0220] FIGS. 6A-6G illustrate various embodiments of force sensors
disposed on or in a vaginal dilation device. In FIG. 6A, force
sensor 646 is disposed on a surface of pad 602. In FIG. 6B, force
sensor 646 is disposed below a surface of pad 602. In FIG. 6C,
force sensor 646 is disposed on a surface of pad support 640, below
pad 602. In FIG. 6D, multiple force sensors 646 are disposed below
a surface of pad 602. In FIG. 6E, multiple force sensors 646 are
disposed on a surface of pad support 640, below pad 602. FIG. 6F
illustrates on embodiment of a vaginal dilation device 600,
including both a diameter gauge 618a and a force gauge 618b, as
well as force sensors 646 disposed on pads 602. In FIG. 6G, force
sensor 646 is positioned proximally from arms 604. When arms 604
and pads 602 expand to dilate tissue, the arms can apply pressure
to 646, which can measure the applied force.
[0221] FIGS. 7A-7B show embodiments of a vaginal dilation device
700 covered with a protective sheath 758, to create an expandable
sterile barrier to prevent infection prior to and after delivery.
The protective sheath can be an elastic material, such as latex,
silicon, etc. In some embodiments, the sheath could also be made
from a non-elastic material that is folded in and around the
device, and unfolds as the device is expanded.
[0222] FIGS. 8A-8D illustrate various embodiments of a vaginal
dilation device 800 comprising working channels or through-ports.
In FIG. 8A, device 800 includes a through-port 860 through which a
user can insert other devices such as cervical monitoring devices,
scopes, fetal monitoring devices, or cervical dilating devices. In
addition, other commonly used tools such as air, water, suction,
surgical cutting devices, ultrasound or other imaging devices, etc
can be inserted into the through port. In FIGS. 8B-8C, vaginal
dilation device 800 can include a flexible working channel 862. The
working channel can comprise a flexible, bendable material, and can
accommodate any of the devices described above. In FIG. 8B, the
working channel can be routed through the handle of the vaginal
dilation device and out through a central axis of the pads 802. In
FIG. 8C, the working channel can be routed along the side of the
handle of the device, through the open space between the pads when
they are expanded. FIG. 8D illustrates the working channel routed
along the side of the handle and through the open space between
pads 802, extending out through a protective sheath 858. There
could be seals around the working channels and through-ports of
FIGS. 8A-8D to keep the anatomy sterile. The working channels or
through-ports can incorporate a one way valve to allow removal of
fluids or tissue without allowing bacteria or other particles to
enter the patient.
[0223] FIG. 9 illustrates a vaginal dilation device 100 having a
quick-release mechanism. The quick-release mechanism can comprise
bump-release 120, quick-release lever 122, and quick-release pin
164. The device shown in FIG. 9 is a simplified version of the
device 100 described above, and includes central rod 124 and
shuttle assembly 125. The description relating to the quick-release
mechanism can be applied to any of the vaginal dilation devices
described herein.
[0224] In situations where the vaginal dilation device 100 needs to
be removed from the patient quickly, quick-release lever 122 can be
pulled or flipped to and contract the device back to a near closed
configuration. This feature allows the user to quickly stop the
device from applying force to the tissue, and prevents tissue from
being pinched during a quick retraction. When quick-release lever
122 is actuated, it releases a spacer which allows central rod 124
to move distally away from the handle 106 of the device. This moves
shuttle assembly 125 away from the handle which changes the angle
of the arms and moves the pads (not shown) towards the central rod
of the device.
[0225] FIGS. 10A-10B illustrate a vaginal dilation device 100
having a quick-release mechanism in use. In FIG. 10A, the device
100 is shown inserted into the patient's vagina as the fetus is
near delivery. Ideally, the device can be removed prior to the
fetus breaching the cervix, so the user can actuate quick-release
lever 122 to collapse the device into the closed configuration for
removal. However, in some instances, the fetus may enter the
vaginal canal with the device 100 still in place. In this
situation, the fetus can engage the bump-release 120, as shown in
FIG. 10B, to collapse the device into the closed configuration for
easy removal. In some embodiments, actuation of the bump-release
can trigger an alarm or visual/audible signal to alert a physician
that the fetus has contacted the device.
[0226] FIGS. 11-12 illustrate the bones and surround tissues of the
female reproductive anatomy. The pelvic floor is defined by the
pubococcygeus-puborectalis muscle complex PC, which forms a
V-shaped sling running from the either pelvic sidewall anteriorly,
and posteriorly around the anorectal junction. The levator hiatus
is the V-shaped space between the muscular walls. Inside this V
shape lies the urethra U (anteriorly), the vaginal canal VC
(centrally) and the anus A (posteriorly). The area of the levator
hiatus in young nulliparous (women who have never given birth)
women varies from 6 to 36 cm 2 on Valsalva manoeuvre. The bones
surrounding the pelvic region, including the Pubic Sympisus, the
Pubic Crest, and the Ischium, can also be seen in FIGS. 11-12.
[0227] The area of the average fetal head in the plane of minimal
diameters measures 70-100 cm.sup.2 (equating to a head
circumference of 300-350 mm), requiring marked distension and
deformation of the levator complex. It has been shown with the help
of MRI-based computer modeling that the most inferior and medial
parts of the levator complex have to increase in length by a factor
of 3.26 during crowning of the fetal head. Given this degree of
acute distension, it is remarkable that severe muscular trauma is
not even more prevalent, as such stretch is commonly thought to be
well beyond the approximately 150% elastic limits of tissue
strain.
[0228] FIGS. 13A-13B illustrate a vaginal dilation device 100
inserted into a female patient in both a closed and expanded
configuration, respectively. The vaginal dilation device of FIGS.
13A-13B can be any vaginal dilation device described herein. In
FIG. 13A, the device 100 is shown inserted into the vagina in a
closed configuration. The outer diameter of the device in the
closed configuration can be less than 4 cm to increase patient
comfort. FIG. 13B illustrates device 100 inserted into the vagina
in an expanded configuration. The outer diameter of the device in
the expanded configuration can be up to approximately 10 cm. The
orientation of pads 102 with respect to the anatomy is also shown.
In FIG. 13B, vaginal dilation device 100 includes four pads 102.
When the pads are expanded, the pads avoid placing pressure on
critical parts of the anatomy, such as the urethra U and the
perineum and anus A. In other embodiments where more than four pads
are incorporated in the device, the device does not include pads
that expand directly upwards (to avoid putting pressure on the
urethra) or directly downwards (to avoid putting pressure on the
perineum and anus).
[0229] Methods of using a vaginal dilation device will now be
described. FIGS. 14A-14D illustrate a vaginal dilation device
inserted into a female patient during labor. The vaginal dilation
device described in these methods can be any vaginal dilation
device described herein, including the fully manual vaginal
dilation device of FIGS. 1-2, the semi-automated vaginal dilation
device of FIG. 3, or the fully semi or fully-automated vaginal
dilation device of FIG. 4. In addition, the vaginal dilation device
shown in FIGS. 14A-14D may include any of the additional features
described herein, including force sensors, diameter gauges/sensors,
working channels, protective sheaths, etc.
[0230] In FIG. 14A, vaginal dilation device 1400 is shown inserted
into the vagina of a patient and can include pads 1402, actuation
mechanism 1408, diameter gauge 1418a, and force gauge 1418b. The
device can include sensors for measuring force and/or diameter, not
shown, but described above. In the embodiment of FIG. 14A, the
device is shown with an actuation mechanism comprising a mechanical
knob, but it should be understood that in other embodiments, the
actuation mechanism can comprise a constant force device such as a
spring, or a fully automated system such as a controller and a
motor. The device 1400 of FIG. 14A is shown in a closed or compact
configuration. The device can be inserted into the patient any time
during the first phase of labor, typically when the patient arrives
at the hospital prior to giving birth. On average, a woman spends
14 hours in a hospital until the second phase of labor begins.
Diameter gauge 1418a can give an indication of the outer diameter
of the pads of the device, to indicate how far the vaginal tissue
has dilated. Force gauge 1418b can indicate the amount of force
being applied by the pads to tissue, or alternatively, the amount
of forced applied against the pads.
[0231] FIG. 14B illustrates the vaginal dilation device 1400 after
being partially dilated. Diameter gauge 1418a indicates the
expanded diameter of the device to a user. Force gauge 1418b can be
monitored by the user, or alternatively, by a controller (not
shown) to ensure proper, safe use of the device and to prevent
trauma to the tissue. In FIG. 14C, vaginal dilation device is shown
in a fully expanded configuration, effectively dilating the vaginal
tissue to the desired diameter (e.g., 10 cm). Diameter gauge 1418a
indicates that the diameter of the device has reached the target
diameter to a user. Force gauge 1418b can be monitored by the user,
or alternatively, by a controller (not shown) to ensure proper,
safe use of the device and to prevent trauma to the tissue. FIG.
14D is an alternate view of a vaginal dilation device in an
expanded configuration. The device shows diameter and force gauges
1418a and 1418b on the top of the device for easy readout by the
user. Pads 1402 are shown applying pressure to the vaginal tissue,
but avoiding putting pressure on the sensitive tissue areas of the
urethra, the perineum, and anus.
[0232] FIG. 15 is a chart illustrating two methods of dilating
vaginal tissue in a case study. Referring to the chart, the
diameter of vaginal tissue was increased from 1.1 cm to 7 cm over a
period of 1 hour and 15 minutes. The amount of force applied to
tissue was ramped up gradually to avoid tissue damage. For example,
initially, a force of approximately 2.5 lbs. was applied by the
device to tissue to dilate the tissue to 4 cm after approximately
500 seconds. After the initial dilation, the tissue was allowed to
relax, and it can be seen that the force applied by the device to
tissue decreased to almost 1 lb. after approximately 1000 seconds.
Next, a force of approximately 3 lbs. was applied by the device to
tissue to dilate the tissue to 4.5 cm, followed by a time period of
no additional dilation which allowed the force applied to decrease
to below 2 lbs. This process was repeated by applying approximately
4.5 lbs. of force to dilate the tissue to 5 cm, applying
approximately 5.5 lbs. of force to dilate the tissue to 5.5 cm,
applying approximately 4 lbs. of force to dilate the tissue to 6
cm, applying approximately 6 lbs. of force to dilate the tissue to
6.5 cm, and applying approximately 7 lbs. of force to dilate the
tissue to 7 cm.
[0233] It should be understood that these values are merely
explanatory, as every woman's body and tissue response to treatment
may be different. In general, however, a method of dilating vaginal
tissue can comprise inserting a vaginal dilation device into the
vagina, measuring a force applied by the vaginal dilation device to
the vagina, dilating the vagina with the vaginal dilation device,
and pausing or stopping dilation of the vagina with the vaginal
dilation device when the force applied by the vaginal dilation
device to the vagina increases to a first force threshold. In some
embodiments, the method further increases measuring a diameter of
the vagina with the vaginal dilation device. Next, the method can
include resuming dilation of the vagina when the force applied by
the vaginal dilation device to the vagina decreases to a second
force threshold. For example, a user or controller may determine
that the tissue has relaxed enough that it is time to begin
dilating the vaginal tissue to a larger diameter. In some
embodiments, dilation is resumed until the force applied by the
vaginal dilation device increases to the first force threshold, or
alternatively, until the force applied increases to a third force
threshold larger than the first force threshold. In some
embodiments, the first, second, and third force thresholds range
from approximately less than 8 lbs. of force.
[0234] The embodiment of FIG. 15 can utilize the visco-elastic
properties of the patient's muscle and connective tissue to achieve
maximum dilation. The tissue can be stretched to some predetermined
maximum stress or force with the device, then the tissue can be
allowed to relax to reduce the stress, followed by again increasing
the diameter of the device to the maximum stress value. This cycle
of tissue stressing, tissue stress relaxation, and then diameter
increases to re-stress the tissue can be performed until the full
tissue preparation diameter of approximately 10 cm is achieved.
[0235] FIG. 16 is a chart illustrating another method of dilating
vaginal tissue during labor at a constant force. FIG. 16
illustrates the results of a constant force dilation from a case
study. Vaginal tissue can be dilated at a constant force with any
of the vaginal dilation devices described herein, but particularly
with the vaginal dilation devices described in FIGS. 3 and 4.
Referring to the constant force dilation chart of FIG. 16, the
vaginal diameter was increased from a baseline diameter of 1.0 cm
up to 5.5 cm over approximately 1 hour. The force was held to lower
values by incrementally increasing the diameter in smaller steps
more frequently. As in the incremental dilation test (described
above in FIG. 15), there is a rapid decrease in force when first
dilating to a new diameter, and by increasing the diameter more
frequently, the tissue is allowed persistent stress relaxation.
[0236] FIG. 17 is a chart illustrating the various phases of labor
and the relative dilation diameters of the patient's cervix and
vagina. During the latent or first phase of labor, the cervix
dilates up to approximately 3-4 cm over a span of about 8 hours.
Over the final 6 hours or so of labor, the cervix dilates to
approximately 10 cm. The natural stretch of perineal tissues is
also shown in FIG. 17. It can be seen that the natural tissue
response is for the perineal tissues to be dilated naturally at
approximately 2 cm, until the final moment of labor when the
perineal tissues stretch to 10 cm, leading to tearing and tissue
damage. In one embodiment, the perineal tissues can be gradually
dilated and expanded with a vaginal dilation device. For example,
the perineal tissues can be dilated with the vaginal dilation
device to approximately 7-10 cm during the first phase of labor.
During the second phase of labor, the vaginal dilation device can
be removed from the patient, allowing the birth to occur while the
perineal tissues are stretch and relaxed.
[0237] The vaginal dilation devices described herein can be used
during the first stage of labor, in the hospital, under the
supervision of trained physician obstetricians and nurses. The
device can be designed as a single use, disposable dilator
configured to penetrate the first third of the vagina, and
configured to gradually expand the vagina and the perineal tissues
from a resting diameter of 2-3 cm to a fully expanded diameter in
preparation of the delivering an infant, roughly 10 cm. Expansion
can be controlled either manually or via an automatic actuation
system, and the device can be removed quickly if needed
[0238] The device could be inserted any time during the first stage
of labor, and can be configured to dilate in small 5-15 minute
increments. In between dilations, the patient can remove the device
and ambulate if needed. The progression of the cervix could be used
as a guideline of the progression of labor. In order to reduce or
eliminate any discomfort, the device can be used under epidural
analgesia or local anesthesia on the vagina. In some embodiments,
the device can dilate the tissue for approximately 1-3 hours to
successfully reduce the internal stresses in the tissue and prepare
the tissue for the second phase of labor. The device can then be
removed prior to the second phase of labor begins, so as to allow
delivery to occur unobstructed.
[0239] FIG. 18 is a chart illustrating an additional method of
dilating vaginal tissue during labor. In FIG. 18, another
embodiment of dilating vaginal tissue is illustrated. In this
embodiment, the vaginal dilation device is configured to dilate the
tissue at a constant rate. As the device dilates the tissue, the
force applied by the device to the tissue will increase. This
method can be used in situations where it is necessary to dilate
the tissue quickly. A typical female has a resting vaginal diameter
of approximately 2-3 cm. In one embodiment, it is desired to dilate
the vagina to approximately 9-10 cm over the course of two hours,
or approximately 3.5 cm per hour. Thus, in this embodiment, a
constant rate dilation method could include dilating the device at
a constant rate to achieve approximately 3-3.5 cm of dilation per
hour. This could be achieved in a number of ways, such as dilating
approximately 0.5 cm every 10 minutes, 1 cm every 20 minutes, etc.
Any of the devices described herein can be used to dilate at a
constant rate. For example, referring to the devices of FIGS. 1-2,
the expansion mechanism or knob can be rotated at set intervals or
at a constant rate to achieve a constant rate of dilation. The
diameter gauge can be monitored in combination with rotation of the
expansion mechanism to achieve a constant dilation. Similarly, the
automated system of FIG. 4 could be programmed to expand the device
at any desired rate for any period of time.
[0240] FIGS. 19A-19B illustrate another embodiment of a vaginal
dilation device 1900. The device can include pads 1902, handle
1906, arms (not shown), expansion mechanism 1908 central rod 1924,
diameter gauge 1918, and any of the features described above and
shown in the Figures herein. In the embodiment of FIGS. 19A-19B,
expansion mechanism 1908 comprises a trigger assembly configured to
expand the device by a preset dilation increment.
[0241] FIG. 19B illustrates a cutaway view of device 1900. In FIG.
19B, central rod 1924 can comprise a hexagonal or non-circular
shape, and plates 1966 can be configured to engage the central rod
to prevent the rod from travelling axially. When the trigger
assembly is actuated, it causes plates 1966 to become parallel,
allowing the central rod to move axially. As the trigger assembly
is actuated, the central rod moves proximally, causing arms (not
shown) and pads (not shown) to expand outwardly from the device, as
described above in the other embodiments of the vaginal dilation
device.
[0242] In some embodiments, a single "click" or actuation of the
trigger assembly can be configured to dilate the device by a preset
set dilation increment. For example, the device can be configured
to expand a precise amount with each actuation of the trigger
assembly. This design makes device 1900 particularly suitable for
use in a constant rate dilation scheme. In one embodiment, for
example, the trigger assembly can be configured to expand the
device by a preset dilation increment (e.g., approximately 0.5 cm)
with every "click" or actuation of the trigger. The user can then
actuate the trigger assembly after a pre-determined period of time
(e.g., every 10 minutes) to dilate the device at a constant rate.
In other embodiments, device 1900 includes force sensors, as
described above, and the user can dilate the device based on the
sensed force of the device. It should be understood that in other
embodiments, the preset dilation increment can be any amount (e.g.,
0-1 cm per actuation, 0-2 cm per actuation, 0-3 cm per actuation,
0-4 cm per actuation, etc) and the predetermined period of time can
be any period of time (e.g., anywhere from 0-2 hours or even
longer).
[0243] All embodiments of the vaginal dilator devices described
herein can be used in other applications beyond dilating vaginal
tissue for childbirth. For example, in one embodiment, the vaginal
dilator devices described herein can be used for the treatment of
vaginismus. In contrast to using the vaginal dilation devices
described herein to prepare a woman for childbirth, in which a
target tissue diameter is somewhere in the range of 8-10 cm, when
using a vaginal dilator to treat vaginismus it may be desirable to
only dilate the vaginal muscles from 1-4 cm. Thus, many features
described herein, which enable the vaginal dilation device to
expand to greater than 10 cm, are unnecessary in a vaginismus
application. Instead of starting at a base diameter of 1 cm and
expanding to 10 cm or more, a vaginismus dilation device according
to one embodiment may expand from 1 cm to 4 cm to treat vaginismus.
A method of treating vaginismus can comprise, for example,
expanding a vaginal dilation device described herein into a vagina
of a patient, and expanding the device to up to 4 cm. A vaginal
dilation device can be expanded in a vagina at a constant rate to
treat vaginismus, or alternatively, the vaginal dilation device can
be expanded in the vagina with a constant force. The user of the
device can monitor the force being applied by the device to the
vagina, as well as the diameter of the device within the tissue.
Additionally, any of the devices described herein can be used as
vaginal exercise devices, or additionally, as cervical dilator
devices.
[0244] FIG. 33 illustrates one embodiment of a vaginal dilation
device 3300 optimized to treat vaginismus. Since the device need
only expand to approximately 4 cm, the scissor-like expansion
mechanisms described above can be replaced with a simple cone
structure 3302. The cone structure can be coupled to a central rod
3304. Manual rotation of knob 3306 can pull central rod and cone
structure proximally. Pads 3308 can include an internal cam surface
3310 configured to engage the cone structure. As the cone structure
travels proximally, the internal cam surface 3310 of pads 3308
pushes the pads outwards, expanding tissue. It should be understood
that any of the constant force (e.g., spring) or automated (e.g.
motor) embodiments described above can be applied to the device of
FIG. 33 in place of the manual knob.
[0245] Another embodiment of an expandable vaginal dilation device
is shown in FIG. 34. In this embodiment, the device utilizes a
living hinge structure 3402 configured to expand in diameter when
compressed axially. The axial compression of the device can be
similar to any of the embodiments described above, in which a
central rod is moved proximally within the device. The advantage of
having small hinges as shown in FIG. 34 can be to increase the
initial angle of the hinge, thus requiring less initial force to
open and expand the device.
[0246] In another embodiment, instead of preparing a woman for
childbirth or treating a vaginismus condition, a vaginal dilation
device can instead be used as a home workout device, similar to
"Kegel Exercises." In these embodiments, a user can use flex the
vaginal muscles against any of the vaginal dilation devices
described herein to build muscle strength to treat pelvic floor
disorders. In these embodiments, vaginal dilation devices that
provide an adjustable force and/or display the force applied by the
device or the diameter of the device are preferred.
[0247] In FIG. 35, vaginal exercise device 3500 comprises a simple
expansion mechanism comprising a pair of arms 3502 pivotable
against a central rod 3504. A spring or other constant force
mechanism 3506 can apply a pre-load force against the arms, thereby
causing pads 3508 to expand outwards at the pre-load force. A force
dial 3510 can give the user feedback as to the actual force applied
by the user against the device. With this device, the user can
adjust the amount of force applied by the device to the tissue with
knob 3512, as well as see the amount of resistance applied by the
user to the device.
[0248] FIG. 36 illustrates various embodiments of a cervical
dilation device 3600. The cervical dilation device can incorporate
any of the features of the vaginal dilation devices, described
above. Additionally, the pads of the device as well as extension
apparatus 3602 can be configured to provide access to the anatomy
of the cervix. The cervical dilation device can be used during
labor to accurately determine the diameter of the cervix and/or
help along the cervical dilation process. Any of the methods
described above, relating to vaginal dilation, can be instead used
to dilate a cervix of the patient. In some embodiments, the
cervical dilation device is configured to dilate the cervix from
approximately 1 cm to 10 cm.
[0249] As for additional details pertinent to the present
invention, materials and manufacturing techniques may be employed
as within the level of those with skill in the relevant art. The
same may hold true with respect to method-based aspects of the
invention in terms of additional acts commonly or logically
employed. Also, it is contemplated that any optional feature of the
inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein. Likewise, reference to a singular item,
includes the possibility that there are plural of the same items
present. More specifically, as used herein and in the appended
claims, the singular forms "a," "and," "said," and "the" include
plural referents unless the context clearly dictates otherwise. It
is further noted that the claims may be drafted to exclude any
optional element. As such, this statement is intended to serve as
antecedent basis for use of such exclusive terminology as "solely,"
"only" and the like in connection with the recitation of claim
elements, or use of a "negative" limitation. Unless defined
otherwise herein, all technical and scientific terms used herein
have the same meaning as commonly understood by one of ordinary
skill in the art to which this invention belongs. The breadth of
the present invention is not to be limited by the subject
specification, but rather only by the plain meaning of the claim
terms employed.
* * * * *