Patent Description:
There are several conditions that can lead to chronic pelvic pain. One example is a condition called Vaginismus, which is a physical and/or physiological condition in which pelvic muscles are chronically contracted, which can lead to constant pain and discomfort. The condition can cause involuntary tightness of the vagina during intercourse, caused by contractions of the pelvic floor muscles surrounding the vagina. Vaginismus can be painful, thereby affecting a women's ability to engage in any form of vaginal penetration, including sexual intercourse and insertion of tampons. There are several other primary conditions that can cause pelvic pain that eventually lead to hypertonic pelvic muscle contractions.

It is estimated that approximately several hundred thousand women seek treatment for pelvic pain in the United States every year. The current treatment for vaginismus involves the use of vaginal dilators of increasing size to stretch the pelvic muscles and train the muscles to relax. These vaginal dilator kits typically include several dilators of varying sizes, typically <NUM>-<NUM> individual dilators. Users insert the dilators into the vagina, typically starting with the smallest diameter dilator, and slowly work up to larger diameter dilators as they become comfortable with each insertion. Currently, the average patient uses dilators for over <NUM> months before becoming comfortable with their largest target diameter. Vaginal dilators combined with appropriate exercises have helped some women overcome these involuntary muscle contractions. However, traditional dilator sets are cumbersome and bulky to use and store, requiring multiple dilators of differing sizes.

<CIT> discloses a vaginal exercise device, 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.

<CIT> discloses a cervical dilator comprising: a dilating element for insertion into a cervical canal, said dilating element having a distal end and a proximal end separated from each other along a longitudinal axis of the dilating element, the dilating element further comprising an expandable malecot; and an insertion depth limiter, sized, shaped and arranged to limit the depth by which the malecot can be inserted into the cervical canal.

<CIT> discloses a device for measuring an inside shape of a vagina. The device includes a device body, operationally connected to one or more movable cheeks, the cheeks movable in a direction substantially transaxially relative to the device body longitudinal axis, and a width indicator, for indicating a distance between opposite faces of the cheeks.

According to the present invention there is provided the vaginal dilation device of claim <NUM>. Additional aspects of the invention are set out in the dependent claims.

The devices and methods described herein are intended to prepare and dilate vaginal tissue to stretch the muscles of the pelvic floor and train the pelvic muscles to relax. The devices and methods described herein can be used to overcome the physical and/or physiological conditions that cause vaginismus, or involuntary tightness or contractions of the pelvic muscles in women. Expansion of the devices described herein can be controlled either manually by the user or with an automatic expansion mechanism. The devices described herein can include additional features, including force and/or diameter sensors, vibration features, and data logging features to track the usage of the device.

The devices described herein can include an expandable vaginal dilator configured to treat vaginismus. The expandable vaginal dilator is a single device that can replace a set of dilators of different sizes that is commonly used to treat vaginismus. In some embodiments, the devices described herein includes a shaft portion with an expandable portion that increases in diameter and a tip portion that maintains a constant profile and does not expand while the expandable portion is expanded.

The devices described herein can include features that increase the ease of use, including an expandable cover to seal the device and enable easy cleaning, and a charging dock or case configured to charge a battery of the device.

<FIG> illustrates a cross-sectional view a vaginal dilation device <NUM> in a closed or compact configuration. Vaginal dilation device <NUM> can include, among other features, a central rod <NUM>, spines <NUM>, arms <NUM>, a handle or frame <NUM>, distal arms <NUM>, distal tip <NUM>, a shaft portion <NUM>, a motor <NUM>, and electronic controller <NUM>. The shaft portion generally comprises the portion of the device that extends along the central rod, spines, distal arms, and distal tip (e.g., the portion of the device distal to the handle or frame). The motor <NUM> can be coupled to the central rod <NUM> and configured to expand the spines <NUM> and arms <NUM> radially outwards from the central rod. The motor <NUM> can be a rotational motor. In some embodiments, the central rod <NUM> is directly connected to the motor <NUM>, and in other embodiments, the central rod <NUM> can be mechanically coupled to the motor via a separate coupling device. For example, in <FIG>, the proximal end of the central rod <NUM> can be bent into a coupling device which is connected to the rotating shaft of the motor. In either approach, one full rotation of the motor results in one full rotation of the central rod <NUM>. Power to the device can be provided via a battery within the handle, or by being plugged directly into a power outlet.

<FIG> shows a cross-sectional view of the vaginal dilation device <NUM> of <FIG>, but in the expanded configuration. Here it can be seen that the spines <NUM> and arms <NUM> have been expanded radially outwards from the central rod <NUM> of the device. It can also be seen that the spines expand to be generally parallel with each other and with the central rod <NUM>. The distal arms <NUM> also expand slightly outwards from the central rod <NUM> and provide a rigid slope between the distal tip <NUM> and the expanded spines <NUM>.

<FIG> shows the vaginal dilation device <NUM> in closed or compact configuration. When the device is in the closed configuration of <FIG>, spines <NUM> can be configured to rest near or against each adjacent spine so as to reduce the outer diameter of the device. In some embodiments, the diameter of the device (e.g., the distance between opposing spines) can be approximately <NUM>. In other embodiments, the spines do not rest against adjacent spines in the closed configuration, but this can result in the minimum outer diameter of the spines being larger, or alternatively, in the individual spines <NUM> having a smaller surface area, which may lead to patient discomfort during tissue dilation.

<FIG> shows the vaginal dilation device <NUM> in an open or expanded configuration. In the expanded configuration, the spines expand parallel to each other and to the central rod out to a maximum diameter of expansion. In some embodiments, this maximum diameter of expansion (e.g., the distance between opposing spines) is approximately <NUM>. In this expanded configuration, the diameter of the device at the distal tip <NUM> remains constant. In one embodiment, the diameter of the distal tip is <NUM>, which can be the same as the diameter of the device in the closed or compact configuration. The distal arms provide a slope or ramp between the distal tip and the spines when the device is in the expanded configuration. Thus, the diameter of the device where the distal arms meets the distal tip is the same as the diameter of the distal tip, and the diameter of the device where the distal arms meets the spines is the same as the distance between opposing spines.

As the device dilates to the expanded configuration, as shown in <FIG>, spines <NUM> and arms <NUM> of the device move radially outwards from the central rod, causing the spines to separate from one another. In some embodiments, the maximum diameter of the device can be approximately <NUM> in diameter in the expanded or dilated configuration. As can be seen from <FIG>, the distal tip maintains a constant profile or diameter between the closed and expanded configurations, i.e., the shape/profile and/or the diameter of the distal tip of the shaft portion does not change when the device is expanded. Furthermore, the distal arms provide a ramp or slop between the distal tip and the expanded spines.

<FIG> is a perspective view of the vaginal dilation device <NUM> which further illustrates how the device expands from the closed configuration to the expanded configuration. As described above, the device <NUM> can include central rod <NUM>, spines <NUM>, arms <NUM>, handle or frame <NUM>, distal arms <NUM>, distal tip <NUM>, and a motor (not shown) that rotates the central rod to expand the arms and spines. <FIG> also shows buttons <NUM> and <NUM> which can be used to control expansion and contraction of the device. A diameter gauge <NUM> displays the diameter of the device (e.g., the distance between opposing spines). Button <NUM> can be used to activate a vibration feature of the device. In one embodiment, the device includes a vibrating element <NUM> disposed on or near the distal tip <NUM>.

The diameter gauge <NUM> can be coupled to one or more sensors on or in the device, such as diameter sensors. In one embodiment, the diameter sensor is a rotary encoder that converts the rotary motion or rotation of the shaft into an analog or digital code that can be used the controller to determine the diameter of the shaft portion of the device. In the embodiment of <FIG>, the diameter gauge <NUM> is disposed on handle or frame <NUM>, 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 diameter gauge can be configured to indicate a diameter of the shaft portion of the device. A user can then refer the gauge to know the exact amount of tissue dilation. Diameter gauge <NUM> can comprise a simple binary readout or can have a scale showing the actual diameter of the device.

In some embodiments, the diameter of the shaft portion of the device can be recorded and stored by the controller of the device. This information can later be reviewed to reveal dilation history and progress. Recording the diameter can allow a user to track the exact diameter achieved, the timing between expansion, etc..

<FIG> further illustrates proximal hub <NUM> and mid hub <NUM>. The arms <NUM> can each have one end connected via pins to the spine <NUM> and the other end connected to either the proximal hub or mid hub, depending on their location along the central rod. The proximal hub can be fixed relative to the motor, and can be attached directly to a distal end of the frame or handle <NUM>. An interior of the mid hub can be threaded so as to engage corresponding threads of the central rod <NUM>. When the motor is operated in the expansion direction it rotates the central rod, which engages the threads inside of the mid hub to draw the mid hub towards the proximal hub. As the mid hub is drawn towards the proximal hub, the angle of the arms relative to the central rod increases. The arms "stand up" as the mid hub moves proximally, thereby lifting the spines away from the central rod of the device. The spines <NUM> remain parallel to each other and to the central rod because there are multiple sets of arms per spine spaced along the length of the spine. The distal arms <NUM> connect the spines <NUM> to the distal tip <NUM>. As the device expands, the angle between the distal arms <NUM> and the central rod also expands. The distal arms comprise a rigid material and provide a ramp or slope between the distal tip <NUM> and the spines.

When the vaginal dilation device is collapsed, partially expanded, or fully expanded, as shown in <FIG>, the shaft portion of the device comprises three distinct zones or regions: <NUM>) the distal tip region, <NUM>) the spine region, and <NUM>) the distal arm region. Each of these regions comprises distinct diameter profiles and serves a unique purpose during the treatment of vaginismus.

The distal tip region comprises the length along the shaft portion defined by the distal tip <NUM>. The distal tip region maintains a constant diameter profile, regardless of whether the device is collapsed, partially expanded, or fully expanded. The distal tip region provides a narrow constant tip profile that aids in insertion of the device into the vagina during treatment, regardless of if the device is in the smallest diameter (collapsed) configuration or the fully/partially expanded configuration.

The spine region comprises the length along the shaft portion defined by the spines <NUM>, and represents the largest region of the device. As described above, the spines expand substantially parallel to each other and to the central rod <NUM>. The diameter at a proximal end of the spine region (near the handle) will be substantially the same as the diameter at a distal end of the spine region (near where the spines join with the distal arms <NUM>). As described above, the diameter gauge <NUM> displays the diameter of the device in the spine region (e.g., the distance between opposing spines). Therefore, the spine region is generally tubular in shape and provides a circular, expandable diameter profile that is defined by the user according to the desired diameter. The spine region of the vaginal dilation device provides dilation therapy to the vaginal canal, allowing the user to slowly become comfortable with increased diameters as described above to treat vaginismus.

Lastly, the distal arm region comprises the length along the shaft portion defined by the distal arms <NUM>, between the distal tip <NUM> and the spines <NUM>. When the vaginal dilation device is in the collapsed configuration, the distal arms can lay flat within the device, parallel to the central rod (as seen in <FIG>), and as the device expands, the distal arms gradually "ramp up" to form an angular support between the distal tip and the spines. The distal arm region is generally conical in shape and provides a circular diameter profile that ramps up from the diameter of the distal tip <NUM> (at the distal end of the distal arms) to the diameter between opposing spines (at the proximal end of the distal arms). The gradual increase in diameter along the distal arms from the distal tip to the spines allows the user to easily maneuver and reinsert the device during treatment as the patient feels comfortable.

In the embodiment of <FIG>, the vaginal dilation device <NUM> includes four spines <NUM> and four sets of four arms <NUM>, totaling sixteen arms. It can be seen from <FIG> that two sets of arms connect the proximal hub to each of the spines, and two sets of arms connect the mid hub to each of the spines. In other embodiments, any number of spines and arms can be used. For example, one embodiment comprises as few as two or three sets of spines and arms, and other embodiments can include more than four sets of spines and arms, such as <NUM>, <NUM>, <NUM>, or even <NUM> or more sets of spines and arms. The sets of spines and arms can be arranged symmetrically or asymmetrically around a central rod of the device.

The tissue contacting spines <NUM> and distal arms <NUM> can be designed to maintain stability through all dilation diameters. The spines, distal arms, and arms can comprise a rigid material such as stainless steel, aluminum, hard molded plastic, or the like. The spines and distal arms can be overmolded with a very compliant biocompatible elastomeric material to help evenly distribute force against the tissue and prevent trauma.

Referring still to <FIG>, the vaginal dilation device <NUM> can include an electronic controller <NUM> coupled to the motor within the device and configured to manually or automatically dilate, expand, and contract the spines and arms of the device. The electronic controller can be a printed circuit board (PCB) and can be disposed inside the handle or frame <NUM> of the device. The expansion and contraction of the device can be either manually or automatically controlled by a user by manipulating input device <NUM>, e.g., pushing buttons <NUM> and <NUM>. In some embodiments, the expansion of the device can be controlled in increments by manipulating the buttons. For example, referring to <FIG>, button <NUM> can be used to increase a diameter of the device button <NUM> can be used to decrease a diameter of the device. In some embodiments, the diameter of the device can be adjusted in increments (e.g., <NUM> increments with every press of the button).

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 spines can be used. For example, the arms can be singular arms attached to the spines (e.g., similar to a speculum).

The vaginal dilation device can be sized, shaped, and configured to penetrate approximately the first third, or <NUM>-<NUM>, of the vagina, and to gradually expand the vaginal introitus from a resting diameter of approximately <NUM> to a dilated diameter of approximately <NUM>. In some embodiments, the shaft portion of the vaginal dilation device can include guide markers to see how far the device has been inserted into the anatomy. The vaginal dilation device <NUM> can be configured to expand from a compact, closed configuration, as shown in <FIG>, to an expanded configuration, as shown in <FIG>. When the device is in the closed configuration, the spines can be seamlessly closed against each adjacent spine so as to form a solid shape (e.g., circle, oval, etc).

In some embodiments, the electronic controller of the vaginal dilation device can track and store information relating to the frequency of use of the device, and the amount and duration of which the device was expanded. The vaginal dilation device can collect this data and offer a report of how the user has been using the device, which can be further used by the user or a physician to determine optimal treatment protocols for that specific user.

<FIG> show one embodiment of the vaginal dilation device <NUM> covered with a protective sheath <NUM>, which creates an expandable sterile barrier to prevent infection and protect the moveable parts of the device from bodily fluids. 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. <FIG> shows the vaginal dilation device in the closed or compact configuration, and <FIG> shows the vaginal dilation device in the expanded configuration.

Methods of using a vaginal dilation device will now be described. The vaginal dilation device can be inserted into the vagina of a patient. The device can include sensors for measuring a diameter of the device. After insertion, the device can be expanded by the user. In some embodiments, the user can control the expansion of the device by expanding the device incrementally (e.g., <NUM> per button press, <NUM> per button press, <NUM> per button press, <NUM> per button press, etc.). In some embodiments, the increment of expansion can be customized by the user to be any increment between <NUM> to <NUM>. As the device is expanded within the vagina, a diameter gauge of the device can give an indication of the diameter of the device (e.g., the distance between opposing spines) to indicate how far the vaginal tissue has dilated. The device can be used frequently by the patient to stretch and relax the pelvic muscles to treat vaginismus.

The vaginal dilation device of the present disclosure advantageously allows the user to expand the device while it is already inserted into the vaginal canal, avoiding the intimidating and painful large jumps in diameter between dilator sizes in traditional dilator kits. The user can expand the device in small increments, at their control, as they feel comfortable, which can lead to progressing through their treatment more quickly by expanding the device to larger diameters more quickly while doing so slowly at their control.

As the user becomes comfortable with the diameter, they can also manipulate the device within their vaginal canal, and in and out of the anatomy. This manipulation of the device in the anatomy can help the user become more comfortable with the size of the device. After manipulation, the user can also become more comfortable to increase the device diameter. The distal arms that "ramp up" between the distal tip and the spines allow the user to easily maneuver and reinsert the device as the patient feels comfortable. Additionally, the diameter readout gives the patient clear feedback of their treatment progress and gives the patients very clear goals and targets for their treatment.

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 or measuring a diameter of the device, and dilating the vagina with the vaginal dilation device. In some embodiments, the device can be pre-programmed with optimal treatment protocols, where the device would automatically expand for the patient based on force or diameter for treating the user's specific vaginismus. In other embodiments, the user can manually determine their own optimal expansion program.

Claim 1:
A vaginal dilation device (<NUM>) adapted to expand from a collapsed configuration to an expanded configuration, comprising:
a handle portion (<NUM>);
a distal tip (<NUM>);
a shaft portion (<NUM>) extending distally from the handle portion to the distal tip, the shaft portion comprising:
a spine region extending distally from the handle portion, the spine region comprising a plurality of spines (<NUM>) arranged parallel to each other, the spine region being generally tubular in shape and being configured to expand in diameter as the shaft portion expands from the collapsed configuration to the expanded configuration; and
a distal arm region extending distally from the spine region to the distal tip of the vaginal dilation device, the distal arm region comprising a plurality of distal arms (<NUM>) that connect the distal tip of the vaginal dilation device to a distal end of each of the plurality of spines, the distal arm region being generally conical in shape;
wherein the distal tip of the vaginal dilation device is configured to maintain a constant diameter profile in both the collapsed configuration and the expanded configuration;
characterised in that the distal arm region is configured to provide a gradual increase in diameter along the shaft portion from the distal tip to the spine region.