Patent Description:
Urethral closure pressure must be greater than urinary bladder pressure, both at rest and during increases in abdominal pressure, to retain urine in the bladder. Measurements of urethral closure pressure using intraurethral catheters have shown that, when a patient is supine, the resting pressure in the bladder neck is about <NUM> H2O, and increases to about <NUM> H2O in a healthy patient approximately halfway along the urethra, after which it decreases to atmospheric pressure at the external meatus of the urethra. Urinary incontinence (UI) occurs when the bladder pressure exceeds the maximum urethral closure pressure, and is one of the most prevalent conditions of the lower urinary tract. The most common type of UI is stress urinary incontinence (SUI), which affects a significant number of people, mostly women. During activities, such as coughing, sneezing, laughing, and exercise, when the bladder pressure increases several times higher than resting urethral pressure, a dynamic process should increase the urethral pressure to enhance urethral closure and thereby maintain urinary continence. SUI occurs when this dynamic process fails, and a sudden increase in the intra-abdominal pressure exceeds the urethral pressure, causing the loss of small amounts of urine.

Currently, there is a large gap in treatment options for SUI between conservative methods (Kegels) and surgical intervention (slings).

Some proposed SUI treatments include the delivery of energy to and/or through the urethral wall by precisely placing an elongated probe having an energy delivery element within the urinary tract, as described in <CIT>. These probes can have an anchoring member, such as an inflatable balloon, at a distal portion of the probe that sits in a patient's bladder, and a locking device at the proximal portion of the probe that is placed against the patient's external urethral orifice, urinary meatus and/or adjacent tissue, thereby securing the probe and the energy delivery member in a desirable position within the urethra. These SUI treatments require complicated mechanisms for minimizing movement of the probe relative to the desired treatment site in the urethra and/or paraurethral region, as well as, maintaining patency of the probe lumen. Furthermore, such SUI treatments denature the urethral or paraurethral tissue, and thus, are irreversible.

Other proposed SUI treatments electrically stimulate the nerves, including the sacral nerve or pudendal nerve, as described in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>, or stimulate the bladder itself, as described in <CIT>; or directly stimulate the pelvic floor or periurethral muscles, as described in <CIT>, <CIT>, and <CIT>. However, these SUI treatments require invasive implantation of the electrodes, as well as the electrical energy source, within the patient.

Still other proposed SUI treatments involve transanally or transvaginally stimulating pelvic floor muscles (e.g., the levator ani) in order to emulate Kegel exercises that strengthen the weakened muscles that were previously thought to cause SUI, as described in <CIT> and <CIT> due to loss of their supporting function. Stimulation of the pelvic floor muscles, particularly levator ani muscles, is performed in either a clinical setting or home setting using a probe that carries electrodes (e.g., annular electrodes) that non-specifically stimulate the pelvic floor muscles surrounding the vagina or anus. However, in this case, because the electrical stimulation is non-specific, muscles that are not associated with the SUI, in addition to the dysfunctional muscles, are electrically stimulated. Some SUI treatments target only the dysfunctional pelvic floor muscles that cause the SUI by using biofeedback, as described in <CIT>. However, these systems require the use of relatively large electrodes and involve a complicated setup. One such system includes an array of electrode patches that extend axially along and circumferentially around a probe to measure electromyography (EMG) signals in the pelvic floor muscles, as well as an external stimulation and control unit, requiring clinical intervention to identify and train the weakened pelvic floor muscles that were thought to cause the SUI.

Research, however, indicates that the main factor causing SUI is weak urethral sphincter muscle(s), rather than a loss of support provided by the pelvic floor muscles or the passive tissue beneath the urethra (see <NPL>; <NPL>). Thus, because levator muscle failure is not a prominent feature of SUI, targeting the pelvic floor muscles for stimulation in order to remedy the loss of support has not been effective. Furthermore, despite the fact that the size and shape of pelvic regions vary greatly between females, prior art electrical stimulation devices designed for the treatment of SUI take a one size fits all solution and, thus, may be completely ineffective for a particular set of females due to an improper fitting between the devices and these females.

<CIT> discloses a transvaginal stimulation device, comprising: a probe body sized to fit within a vaginal cavity of a female patient, the probe body having a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth extending perpendicular to the length and width, the probe body having a stimulating side defined by the length and the width of the probe body, the probe body having a pair of convex regions longitudinally extending along the stimulating side of the probe body, and a concave region longitudinally extending along the stimulating side of the probe body between the pair of convex regions; and a pair of sensors disposed on the stimulating side of the probe body and laterally spaced from each other, such that the concave region is disposed between the pair of sensors. The pair of sensors is located between the peaks of the pair of convex regions of the probe body, directly adjacent to the concave region, in immediate proximity to the longitudinal center plane, so as to form a partial grip around the urethra and are intended to register the measured signals generated by the M. sphincter urethrae externus upon contraction thereof.

Hence there is an ongoing need to provide an improved device and technique that non-invasively electrically stimulates the target anatomical regions associated with SUI with minimal clinical intervention.

The invention is directed to a transvaginal stimulation device according to claim <NUM>.

Other and further aspects and features of embodiments of the disclosed inventions will become apparent from the ensuing detailed description in view of the accompanying figures.

The drawings illustrate the design and utility of preferred embodiments of the disclosed inventions, in which similar elements are referred to by common reference numerals. It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. In addition, an illustrated embodiment of the disclosed inventions needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment of the disclosed inventions is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated. In order to better appreciate how the above-recited and other advantages and objects of the disclosed inventions are obtained, a more particular description of the disclosed inventions briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

In contrast to the conventional approaches that treat stress urinary incontinence (SUI) in a female patient, particularly those that stimulate the pelvic floor muscles (e.g., the levator ani), the inventors have discovered that specifically stimulating the urethral sphincter muscle of the female patient will cause a greater contraction of the urethral sphincter muscle, and therefore, result in a relatively higher urethral closing pressure. Because the urethral sphincter muscle extends along <NUM>/5ths the length of the urethra, and is surrounded by other muscles, including the pubococcygeal and puborectal portions of the pelvic floor muscles, specifically stimulating the urethral sphincter muscle while avoiding stimulation of other muscles in a female patient, especially during physical activity of the patient, presents unique challenges. The SUI treatment system described herein consistently and robustly stimulates the urethral sphincter muscle of a physically active female patient suffering from SUI. Although the SUI treatment system described herein lends itself well to the treatment of SUI in human female patients, it should be appreciated that the SUI treatment system described herein can be adapted to treat non-human female patients, e.g., older pets.

As shown in <FIG>, the periurethral components of a female patient <NUM> comprise a detrusor smooth muscle at the neck of the bladder <NUM> and the urethra <NUM>, itself. The urethra <NUM> is approximately <NUM>-<NUM> long in a female, and is embedded in the connective tissue <NUM> supporting the anterior wall <NUM> of the vagina <NUM>, as shown in <FIG>. The urethra <NUM> comprises a urethral sphincter <NUM>, which extends lengthwise along the caudal <NUM>/5ths of the urethra <NUM> to actively control the flow of urine from the bladder <NUM>, and a nozzle <NUM>, which extends lengthwise along the remaining cranial <NUM>/<NUM>th of the urethra <NUM> to passively control the flow of urine from the bladder <NUM>. The urethral sphincter <NUM> comprises three layers of muscle (an outer circumferential layer of striated muscle <NUM>, a middle circumferential layer of smooth muscle <NUM>, and an inner longitudinal layer of smooth muscle <NUM>) and a vascular plexus <NUM> surrounding the urethral lumen <NUM> (see <NPL>)). The circumferential striated muscle <NUM> is under voluntary control, while the circumferential smooth muscle <NUM> and longitudinal smooth muscle <NUM> are under involuntary or autonomic control. It is only the circumferential striated muscle <NUM> that contributes to the voluntary and reflex closure of the urethra <NUM> during acute instances that result in increased abdominal pressure (e.g., coughing, sneezing, laughing, etc.).

The current dogma is that all of the periurethral structural components listed above, including the circumferential striated muscle <NUM>, the circumferential smooth muscle <NUM>, the longitudinal smooth muscle <NUM>, and the vascular plexus <NUM>, contribute equally to urethral closure pressure, and thus, are the primary structures preventing the involuntary release of urine from the bladder <NUM>. As such, all of these periurethral structural components contribute to urinary continence, and when dysfunctional, cause urinary incontinence. Based on this dogma, conventional wisdom dictates that electrical stimulation be conveyed along the entire length of the urethra <NUM> to ensure that all of the periurethral structural components are trained or reeducated, thereby providing maximum efficacy for the treatment of SUI in a female patient.

However, in contrast to this, the inventors have discovered that delivering focused stimulation to the middle region of the urethra <NUM> containing the circumferential striated muscle <NUM> achieves comparatively higher urethral closure pressure, and thus, is more desirable than stimulating all of the periurethral structural components along the entire length of the urethra <NUM> in the patient <NUM>. The inventors have designed and tested an SUI treatment system <NUM> that specifically stimulates the circumferential striated muscle <NUM> (i.e., the mid-urethral striated sphincter muscle) of the female patient <NUM> in a consistent and robust manner even during physical activity of the female patient <NUM>.

Referring now to <FIG>, one embodiment of the SUI treatment system <NUM> generally comprises a transvaginal stimulation device <NUM>, a clinician programmer <NUM>, a patient controller <NUM>, and an external charger <NUM>.

As shown in <FIG>, the transvaginal stimulation device <NUM> is configured for being introduced into a vaginal cavity <NUM> of the patient <NUM>, and for delivering electrical stimulation energy (shown by arrow) only through the anterior wall <NUM> of the vagina <NUM> towards the middle region of the urethra <NUM> to target the mid-urethral striated sphincter muscle <NUM> of the patient <NUM>, which has been found to be at least as effective at increasing urethral closure pressure as stimulating the pelvic floor muscles surrounding the vagina <NUM>, while stimulating far fewer muscles that are not responsible for urinary incontinence.

Once the transvaginal stimulation device <NUM> is inserted into the vaginal cavity <NUM> of the patient <NUM>, the clinician programmer <NUM> can be used to program the transvaginal stimulation device <NUM> in a clinical setting. While it is contemplated that targeted stimulation of the mid-urethral striated sphincter muscle <NUM> of the patient <NUM> by the transvaginal stimulation device <NUM> will provide a robust means for treating the SUI of the patient <NUM>, as will be described in further detail below, it may be desirable to perform a fitting session to fine tune or optimize such treatment. For example, different transvaginal stimulation regimens may be applied to the patient <NUM> by controlling the transvaginal stimulation device <NUM> via the clinician programmer <NUM> and, in response to each stimulation regimen, observing biofeedback in the form of a detected urethral closure pressure, which has been shown to be highly correlated to SUI. The stimulation regimen or regimens that result in maximum urethral closure pressure can then be selected. Different stimulation frequencies are known to be required to recruit striated muscle (i.e., <NUM>) than are required to recruit smooth muscle (<NUM>). The difference in response of the two types of muscle to electrical stimulation of the appropriate frequency can be determined by the time constant of the change in closure pressure, with striated muscle reaching a maximum tetanic contraction in about a fifth of a second, while smooth muscle may take many seconds to reach a maximum contraction.

Using the biofeedback as guidance, the clinician can operate the clinician programmer <NUM> to generate custom stimulation programs (each comprising clinician detailed stimulation parameters) and programming the transvaginal stimulation device <NUM> with the stimulation programs. For example, four exemplary stimulation programs (e.g., warm-up, endurance, massage, cool down) corresponding to four different electrical pulse trains 20a-20d are illustrated in <FIG>. The transvaginal stimulation device <NUM> may be programmed to sequentially step through the different stimulation programs in accordance with a timing protocol, or any one of the stimulation programs may be actuated via the patient controller <NUM>, as discussed below.

In the illustrated embodiment, the clinician programmer <NUM> takes the form of a laptop computer, although in alternative embodiments, the clinician programmer <NUM> may take the form of a conventional Smartphone configured with a smartphone application with programming capabilities. The clinician programmer <NUM> may perform this function by indirectly communicating with the transvaginal stimulation device <NUM>, through the patient controller <NUM>, via a bi-directional wireless communications link (e.g., using a short-range infrared (IR) protocol) <NUM>. Alternatively, the clinician programmer <NUM> may directly communicate with the transvaginal stimulation device <NUM> via the bi-directional wireless communications link <NUM> (e.g., using a short-range radio-frequency (RF) protocol, such as a Bluetooth protocol, although other types of short-range RF protocols, such as a Wi-Fi protocol, can be used). More alternatively, the clinician programmer <NUM> may communicate with the transvaginal stimulation device <NUM> via a wired connection. The clinician detailed modulation parameters provided by the clinician programmer <NUM> may also be used to program the patient controller <NUM>, so that the stimulation parameters can be subsequently modified by operation of the patient controller <NUM> in a stand-alone mode (i.e., without the assistance of the clinician programmer <NUM>).

The patient controller <NUM> may be used to telemetrically control the transvaginal stimulation device <NUM> via a bi-directional wireless communications link <NUM> (e.g., using a short-range RF protocols, such as a Bluetooth protocol, although other types of short-range RF protocols, such as a Wi-Fi protocol, can be used). Alternatively, the patient controller <NUM> may communicate with the transvaginal stimulation device <NUM> via a wired connection. In any event, control by the patient controller <NUM> allows the transvaginal stimulation device <NUM> to be turned on or off, select one of a plurality of different stimulation programs (corresponding to different electrical pulse trains) previously programmed into the transvaginal stimulation device <NUM> via the clinician programmer <NUM>, and to modify other parameters of the electrical stimulation energy (e.g., to adjust the intensity of the electrical stimulation or cause the transvaginal stimulation device <NUM> to ramp up or ramp down the electrical stimulation). The patient controller <NUM> can take the form of, e.g., a Smartphone. The patient controller <NUM> may optionally track patient compliance, send reminders and/or encouragement to the patient, share data with physicians, display remaining time left during a session, and track the patient progress.

The external charger <NUM> is a portable device used to transcutaneously charge the transvaginal stimulation device <NUM> via an inductive link <NUM>. The external charger <NUM> may, e.g., wirelessly charge the transvaginal stimulation device <NUM> or may use contacts to charge the transvaginal stimulation device <NUM>. In the latter case, the external charger <NUM> may take the form of a storage container that completely encloses the transvaginal stimulation device <NUM> during the charging process. Alternatively, the transvaginal stimulation device <NUM> may be recharged by plugging the transvaginal stimulation device <NUM> into a household alternating current (AC) socket. More alternatively, the transvaginal stimulation device <NUM> may not be recharged at all, but instead contains a replaceable non-rechargeable battery. Once the transvaginal stimulation device <NUM> has been programmed by the clinician programmer <NUM>, turned on by the patient controller <NUM>, and charged by the external charger <NUM>, the stimulation programs are run locally on the transvaginal stimulation device <NUM> during a stimulation session, and may thus function as programmed without the patient controller <NUM>, clinician programmer <NUM>, and external charger <NUM> being present. The stimulation sessions may be logged locally on the transvaginal stimulation device <NUM> and uploaded to the patient controller <NUM> or clinician programmer <NUM> when communication has been established over the bi-directional wireless link(s).

Referring now to <FIG>, the electrical components of the transvaginal stimulation device <NUM> will be described. The transvaginal stimulation device <NUM> generally comprises at least one pair of electrodes 30a, 30b (only one pair of electrodes illustrated in <FIG>), programmable stimulation circuitry <NUM>, a microcontroller <NUM>, memory <NUM>, a rechargeable power circuitry <NUM>, and wireless communication circuitry <NUM>.

In the preferred embodiment, the electrodes 30a, 30b are respectively activated as an anode and a cathode, such that electrical stimulation energy is transmitted between the electrodes 30a, 30b in a bipolar manner. Although the electrical stimulation energy may be delivered as monophasic electrical energy (i.e., the pulses are either negative (cathodic) or positive (anodic), it is preferred that the electrical stimulation energy is delivered as multi-phasic electrical energy (e.g., a series of biphasic pulses, with each biphasic pulse including a negative (cathodic) pulse (during a first phase) and a positive (anodic) pulse (during a second phase) to prevent direct current charge transfer through tissue, thereby avoiding electrode degradation and cell trauma.

The programmable stimulation circuitry <NUM> is configured for generating electrical stimulation energy in accordance with a defined pulsed waveform having a specified pulse amplitude, pulse rate, pulse width, and pulse shape. In the preferred embodiment, the stimulation circuitry <NUM> comprises an integrated analog-to-digital converter (ADC) that constantly measures and adjusts the output voltage to maintain a constant current output, thereby guaranteeing constant output to the electrodes 30a, 30b during and between stimulation sessions.

In addition to controlling the operation of the transvaginal stimulation device <NUM>, the microcontroller <NUM> programs the stimulation circuitry <NUM> in accordance with one or more stimulation programs stored in the memory <NUM>. Each of the stimulation programs stored in memory may comprises a set of stimulation parameters (e.g., pulse amplitude (e.g., in the range of <NUM> - <NUM> mA), pulse rate (e.g., in the range of <NUM> - <NUM>), pulse width (e.g., in the range of. <NUM>, and pulse shape) of the electrical stimulation energy (i.e., the pulse train) output by the stimulation circuitry <NUM>. In one embodiment, up to four stimulation programs may be stored in the memory, although in other embodiments, more or less than four stimulation programs may be stored in the memory. The memory may also store a timing protocol in the case where the transvaginal stimulation device <NUM> is programmed to automatically step through the different stimulation programs, as well as log stimulation sessions performed by the transvaginal stimulation device <NUM>.

The rechargeable power circuitry <NUM> comprises a battery, e.g., lithium-ion or lithium-ion polymer battery, and regulation circuitry (not shown). The battery outputs unregulated voltage to the regulation circuitry, which outputs regulated power to the stimulation circuitry <NUM>, as well as the other components, of the transvaginal stimulation device <NUM>. The power circuitry <NUM> is recharged using rectified AC power (or DC power converted from AC power) via the power circuitry <NUM>, which comprises an AC coil (not shown). To recharge the power circuitry <NUM> while the transvaginal stimulation device <NUM> is disposed in the vaginal cavity <NUM> of the patient <NUM>, the transvaginal stimulation device <NUM> may be placed within the external charger <NUM>, which generates an AC magnetic field, or alternatively, the external charger <NUM> is placed against, or otherwise adjacent, to the patient <NUM> over the transvaginal stimulation device <NUM>. The AC magnetic field emitted by the external charger <NUM> induces AC currents in the AC coil of the rechargeable power circuitry <NUM> over the inductive link <NUM> (shown in <FIG>), which rectifies the AC current to produce DC current, which is used to charge the power circuitry <NUM>. Alternatively, the transvaginal stimulation device <NUM> may be recharged in a storage container or external charger while not in use.

The communication circuitry <NUM> comprises an antenna (not shown) for receiving programming data (e.g., stimulation programs) from the clinician programmer <NUM> over the wireless communications link <NUM> (shown in <FIG>), which programming data is stored in the memory, and patient control data (e.g., on/off, amplitude control, stimulation program selection) from the patient programmer <NUM> over the wireless communications link <NUM>. The communication circuitry <NUM> may also transmit status information or logged stimulation sessions to the clinician programmer <NUM> or patient controller <NUM> over the communications link <NUM>.

Referring to <FIG>, one embodiment of a transvaginal stimulation device <NUM> will now be described. Focused stimulation of the mid-urethral striated sphincter muscle <NUM> presents challenges in that the anatomy of the vaginal cavity <NUM> and location of the middle region of the urethra <NUM> relative to the vaginal cavity <NUM> may vary widely over patients. The transvaginal stimulation device <NUM> is aptly and robustly capable of treating a wide variety of patients while focusing stimulation energy on the mid-urethral striated sphincter muscle <NUM> of a patient <NUM>.

The transvaginal stimulation device <NUM> generally comprises a probe body <NUM>, an extraction mechanism <NUM> extending from a proximal region <NUM> of the probe body <NUM>, an optional minimal user interface (UI) <NUM> located on the proximal region <NUM> of the probe body <NUM>, and a pair of electrodes 30a, 30b disposed on the probe body <NUM>. As will be described in further detail below, the transvaginal stimulation device <NUM> may optionally comprise additional pairs of electrodes.

The extraction mechanism <NUM> is designed to extend outside of the vaginal cavity <NUM> of the patient <NUM>, thereby providing a convenient means of extracting the transvaginal stimulation device <NUM> from the vaginal cavity <NUM> of the patient <NUM>, e.g., after a stimulation session has been completed. To this end, the extraction mechanism <NUM> comprises an elongated tail member <NUM> affixed to the proximal region <NUM> of the probe body <NUM>, and a fingerhold <NUM> affixed to the elongated tail member <NUM>. The elongated tail member <NUM> has a pre-shaped C-geometry, such that the fingerhold <NUM> is disposed above the stimulating side 52a of the probe body <NUM> in the absence of force. While the transvaginal stimulation device <NUM> is fully disposed in the vaginal cavity <NUM> of the patient <NUM>, a distal facing surface <NUM> of the fingerhold <NUM> (shown in <FIG>) approximates the pubic bone <NUM> of the patient <NUM>, without placing undue pressure on the clitoris of the patient <NUM>, causing the elongated tail member <NUM> to form an angle with the longitudinal axis of the probe body <NUM> of approximately <NUM> degrees, as illustrated in <FIG>. The fingerhold <NUM> of the extraction mechanism <NUM> also serves as a visual indicator to ensure that the electrodes 30a, 30b of the transvaginal stimulation device <NUM> are facing the anterior wall <NUM> of the vagina <NUM>. That is, when the fingerhold <NUM> is in the <NUM> o'clock position, immediately under the pubic bone <NUM> of the patient <NUM>, as illustrated in <FIG>, the patient <NUM> can visually confirm that the electrodes 30a, 30b of the transvaginal stimulation device <NUM> are facing the anterior wall <NUM> of the vagina <NUM>, and furthermore, that the probe body <NUM> is not cock-eyed (i.e., the distal tip of the probe body <NUM> does not veer left, right, or up). In contrast, if the fingerhold <NUM> is not in the <NUM> o'clock position, the patient <NUM> knows that the transvaginal stimulation device <NUM> must be adjusted to face the electrodes 30a, 30b towards the anterior wall <NUM> of the vagina <NUM>.

In an optional embodiment illustrated in <FIG>, the fingerhold <NUM> is shaped as a loop that may house a radio frequency (RF) antenna to facilitate bi-directional communication between the transvaginal stimulation device <NUM> and the clinician programmer <NUM> and patient controller <NUM> (shown in <FIG>), as described above.

As shown in <FIG> and <FIG>, the minimal UI <NUM> can be actuated by the patient <NUM> to wake up the transvaginal stimulation device <NUM> and to communicate the state of the transvaginal stimulation device <NUM> to the patient <NUM>. The minimal UI <NUM> may also be actuated to turn on the transvaginal stimulation device <NUM> (i.e., activate the stimulation circuitry) or turn off the transvaginal stimulation device <NUM> (i.e., deactivate the stimulation circuitry) to provide the patient <NUM> an alternative means of initiating or ceasing a stimulation session, e.g., if the patient controller <NUM> is lost or otherwise out of reach of the patient <NUM>.

The probe body <NUM> may be semi-rigid or rigid and can be composed of both rigid and flexible sections. The rigid sections of the probe body <NUM> may be composed of a rigid biocompatible plastic, e.g., acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, or other similar plastics, and the flexible sections of the probe body <NUM> may be composed of a biocompatible elastomer, e.g., silicone, polyurethane, nitrile rubber, or other similar materials. The probe body <NUM> is sized and shaped to be fully inserted into the vaginal cavity <NUM> of the patient <NUM>, and may, e.g., take the form of a casing that hermetically contains the internal electrical components described above with respect to <FIG>. Although it is preferred that the stimulation circuitry <NUM> be contained with the probe body <NUM>, in alternative embodiments, the stimulation circuitry <NUM> may reside outside of the probe body <NUM>, in which case, it can be electrically coupled to the electrodes 30a, 30b via an electrical cord (not shown).

The probe body <NUM> has a stimulating side 52a on which the pair of electrodes 30a, 30b is disposed, and a diametrically opposing non-stimulating side 52b completely free of electrodes, such that electrical stimulation energy can only be emitted unidirectionally from the stimulating side 52a of the probe body <NUM>. In the context of the transvaginal stimulation of the mid-urethral striated sphincter muscle <NUM> (shown in <FIG>), the stimulating side 52a can be considered the anterior face of the probe body <NUM>, whereas the non-stimulating side 52b can be considered the posterior face of the probe body <NUM>. As shown in <FIG>, the probe body <NUM> has a length L extending in the longitudinal direction, a width W extending in the lateral direction, and a depth D extending perpendicularly to the length L and width W.

Significantly, the stimulating side 52a of the probe body <NUM> has a transversely scalloped or concave region <NUM> between and extending at least the length I of the electrodes 30a, 30b. As can be best appreciated in <FIG>, this concave region <NUM> of the stimulating side 52a facilitates location of the urethra <NUM> in the middle of the transvaginal stimulation device <NUM> equidistant between the electrodes 30a, 30b. The concave region <NUM> of the stimulating side 52a conforms to the natural convex surface of the anterior wall <NUM> of the vagina <NUM> caused by the urethral carina <NUM> (shown in <FIG>), thereby minimizing stretching of the tissue of the anterior wall <NUM>, which may otherwise occur if the stimulating side 52a had a transversely flat or convex contour. The concave region <NUM> also facilitates low resistance contact of the electrodes 30a, 30b with vaginal tissue and disposes the electrodes 30a, 30b as close to the urethra <NUM> as is possible in a transvaginal approach thereby providing spatial specificity. The concave region <NUM> may have a radius of curvature of, e.g., <NUM> (see <FIG>), and a length commensurate with the length L of the probe body <NUM> (see <FIG>), such that the entire length of the urethral carina <NUM> will be located equidistantly between the electrodes 30a, 30b.

Much of the probe body <NUM> is uniquely shaped with an elliptical cross-section in the transverse plane (see <FIG>) in order to maintain its position (both longitudinally and rotationally) within the vaginal cavity <NUM> of the patient <NUM>, thereby ensuring that the electrical stimulation energy continues to be directed towards and focused on the mid-urethral striated sphincter muscle <NUM> of the patient <NUM>, even when the patient <NUM> is performing physical activity.

To this end, the length L of the probe body <NUM> is commensurate with the length of the vaginal cavity <NUM> (e.g., in the range of <NUM> - <NUM>). The length L of the probe body <NUM> will generally be greater than the width W of the probe body <NUM> to mimic the vaginal cavity <NUM> of the patient <NUM>. Notably, the vaginal cavity <NUM> has a non-circular cross-section, and in particular, is flat and wide, with the anterior and posterior walls of the vagina <NUM> contacting each other. As can be seen in <FIG>, the cross-sectional elliptical shape of the probe body <NUM> reflects the natural shape of the middle and cranial regions of the vaginal cavity <NUM>. Because the cross-section of the natural vaginal cavity <NUM> is non-circular, and in particular, has an elliptical cross-section, the probe body <NUM> likewise has a non-circular (in this case, an elliptical) cross-section, with the greatest lateral extent of its width W being greater than its depth D to mimic the vaginal cavity <NUM>. It can be appreciated that the probe body <NUM> mimics the non-circular cross-section of the vaginal cavity <NUM>, thereby resisting rotation of the transvaginal stimulation device <NUM> relative to the vaginal cavity <NUM>. In contrast, a cylindrical probe body having a circular cross-section would provide little to no resistance to rotation of the transvaginal stimulation device <NUM> within the vaginal cavity <NUM>.

The cross-section in the transverse plane (both width W and depth D) of the probe body <NUM> along its length L is also uniquely shaped to ensure that the transvaginal stimulation device <NUM> is properly seated axially within the vaginal cavity <NUM> of the patient <NUM> in a stable and repeatable manner. In this manner, the electrodes 30a, 30b will be axially aligned with the mid-urethral striated sphincter muscle <NUM> of the patient <NUM> in a consistent manner once the transvaginal stimulation device <NUM> is inserted in the vaginal cavity <NUM> of the patient <NUM>.

To this end, the width W at the proximal region <NUM> of the probe body <NUM> laterally flares outward in the proximal direction to form shoulders <NUM>, and then laterally tapers inward in the proximal direction to its narrowest point to form a waist <NUM>, as best shown in <FIG>. In the embodiment illustrated in <FIG>, the width W2 of the waist <NUM> of the probe body <NUM> is less than half of the width W1 of the shoulders <NUM> of the probe body <NUM>, and preferably less than one-third of the width W1 of the shoulders <NUM> of the probe body <NUM>. For example, the width W2 of the waist <NUM> may be in the range of <NUM> - <NUM>. The axial distance d1 between the shoulders <NUM> of the probe body <NUM> and the waist <NUM> of the probe body <NUM> is preferably in the range of <NUM> to <NUM>, and in the illustrated embodiment, is <NUM>.

The inventors have also appreciated that the cranial end of the vaginal cavity <NUM> widens and angles posteriorly, and have taken advantage of this anatomical feature by shaping a distal region <NUM> of the probe body <NUM> to mimic the cranial end of the vaginal cavity <NUM>. In particular, as illustrated in <FIG>, the width W at the distal region <NUM> of the probe body <NUM> laterally flares outward in the distal direction from a laterally narrow mid-region <NUM> to form the flattened scoop <NUM>. As illustrated in <FIG>, the flattened scoop <NUM> is flattened, having a depth that is substantially less the depth of the mid-region <NUM> of the probe body <NUM>, and angles downward away from the stimulating 52a of the probe body <NUM> to conform to the posteriorly angled cranial end of the vaginal cavity <NUM>.

As illustrated in <FIG> and <FIG>, when the probe body <NUM> is fully disposed within the vaginal cavity <NUM>, the levator ani <NUM> exerts an inward medial compressive force on the laterally narrower mid-region <NUM> between the shoulders <NUM> and the flattened scoop <NUM>, thereby securely seating and facilitating retention of the transvaginal stimulation device <NUM> longitudinally within the vaginal cavity <NUM>. Thus, the probe body <NUM> is axially stabilized within the vaginal cavity <NUM>, naturally helping to prevent it from being expelled by either gravity or intraabdominal pressure. Notably, the laterally narrow mid-region <NUM> of the probe body <NUM> conforms to where a region <NUM> of the levator ani <NUM> naturally indents the lateral margins of the vagina <NUM> inward when the probe body <NUM> is fully disposed in the vaginal cavity <NUM>, thereby facilitating correct seating of the probe body <NUM> within the vaginal cavity <NUM>, and location and retention of the electrodes 30a, 30b adjacent the mid-urethral striated sphincter muscle <NUM>. Furthermore, because the flattened scoop <NUM> is flattened, as best illustrated in <FIG>, the flattened scoop <NUM> serves to further resist rotation of the transvaginal stimulation device <NUM> relative to the vaginal cavity <NUM>.

Referring to <FIG>, the electrodes 30a, 30b have outer exposed, electrically conductive, tissue-contacting surfaces, such that the electrodes 30a, 30b may be placed into electrical contact with tissue, and in this case, the anterior wall <NUM> of the vagina <NUM> in which the transvaginal stimulation device <NUM> is inserted (shown in <FIG>). Significantly, as best shown in <FIG>, the tissue contacting surfaces of the electrodes 30a, 30b, which preferably have flattened faces, form an angle substantially equal to <NUM>° (i.e., disposed on a plane P extending along the stimulating side 52a of the probe body <NUM>), such that the electrodes 30a, 30b are placed into firm contact with in the anterior wall <NUM> of the vagina <NUM> when the transvaginal stimulation device <NUM> is inserted into the vaginal cavity <NUM>. That is, as illustrated in <FIG>, because the anterior wall <NUM> of the vagina <NUM> is generally flat (as opposed to curved about a longitudinal axis of the probe body <NUM>) in nature, contact between the electrodes 30a, 30b and the anterior wall <NUM> of the vagina <NUM> will be maximized if the electrodes 30a, 30b are disposed along the same plane (as opposed to being disposed circumferentially relative to each other as when disposed on a cylindrical probe body), and thus, focused stimulation of the mid-urethral striated sphincter muscle <NUM> will be made as efficient as possible. For the purposes of this specification, the tissue contacting surfaces of the electrodes 30a, 30b form an angle substantially equal to <NUM>°, this angle being within a range of <NUM>° - <NUM>°. Preferably, the tissue contacting surfaces of the electrodes 30a, 30b form an angle within the range of <NUM>° - <NUM>°.

As shown in <FIG>, each of the electrodes 30a, 30b preferably is elongated, i.e., has a length I substantially greater than a width w. Notwithstanding this, each of the electrodes 30a, 30b preferably has a relatively short length l (e.g., in the range of <NUM> - <NUM>), such that the stimulation energy is focused in the region adjacent the mid-urethral striated sphincter muscle <NUM>. The electrodes 30a, 30b have an edge-to-edge lateral spacing s, which should not be so great that the current flowing between the electrodes 30a, 30b passes through the pelvic floor, but should not be so small that the current flows between the electrodes 30a, 30b without passing through the periurethral components of the patient <NUM>. Notably, disposing the electrodes 30a, 30b on a plane along the stimulating side 52a of the probe body <NUM> facilitates minimization of the edge-to-edge lateral spacing s, which may otherwise be prohibitively increased if the electrodes 30a, 30b were radially disposed radially outward relative to the plane P. The edge-to-edge spacing s between the electrodes 30a, 30b is preferably in the range of <NUM> - <NUM>, and more preferably in the range of <NUM> - <NUM>, for optimal stimulation, although other ranges are contemplated by the invention.

Each of the electrodes 30a, 30b has a relatively small width w (e.g., in the range of <NUM> - <NUM>) to accommodate the electrodes 30a, 30b (taking into account the spacing s therebetween) on the limited width of the probe body <NUM>, but large enough, such that the exposed outer surfaces of the electrodes 30a, 30b do not have excessive current density when activated. The electrodes 30a, 30b may protrude a certain distance (e.g., <NUM>) from the surface of the probe body <NUM>. Preferably, the transvaginal stimulation device <NUM> comprises no additional electrodes laterally disposed relative to the pair of electrodes 30a, 30b, such that the pair of electrodes 30a, 30b can convey electrical stimulation energy to the targeted periurethral structure component (in this case, the mid-urethral striated sphincter muscle <NUM>) in a more focused manner. While the current flowing through electrodes 30a, 30b may be similar to prior art pelvic floor stimulators, the transvaginal stimulation device <NUM> can stimulate the mid-urethral striated sphincter muscle <NUM> with considerably lower voltage and power because the mid-urethral striated sphincter muscle <NUM> has a lower impedance than the pelvic floor muscles.

Notably, since the location of each of the electrodes 30a, 30b of the transvaginal stimulation device <NUM> illustrated in <FIG> is fixed relative to the probe body <NUM>, it is important that the electrodes 30a, 30b be axially aligned with the mid-urethral striated sphincter muscle <NUM> once the transvaginal stimulation device <NUM> is properly seated within the vaginal cavity <NUM> of the patient <NUM>. As such, the axial centers of the electrodes 30a, 30b should be located the proper distance d2 on the probe body <NUM> relative to the waist <NUM> of the probe body <NUM>, as illustrated in <FIG>. For example, the distance d1 between the axial centers of the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM> can be in the range of <NUM> - <NUM>.

To ensure proper seating of the waist <NUM> of the probe body <NUM> in the introitus <NUM> of the patient <NUM>, the extraction mechanism <NUM> of the transvaginal stimulation device <NUM> may alternatively be rigid. In this case, because the extraction mechanism <NUM> is rigid, abutment between the distal facing surface <NUM> of the fingerhold <NUM> and the pubic bone <NUM>, as illustrated in <FIG>, prevents the probe body <NUM> from being inserted too far into the vaginal cavity <NUM>, which would otherwise result in improper seating of the transvaginal stimulation device <NUM> within the vaginal cavity <NUM> of the patient <NUM> relative to the urethra <NUM>. It should be appreciated that the distance between the pubic bone <NUM> and the urethral meatus (i.e., the opening to the urethra <NUM>) is generally consistent between patients, and thus, the extraction mechanism <NUM> allows the electrodes 30a, 30b to be axially located relative to the urethra <NUM>, as opposed to the vaginal anatomy of the patient <NUM>, thereby more accurately placing the electrodes 30a, 30b adjacent the mid-urethral striated sphincter muscle <NUM> of the patient <NUM>. It is preferred that the fingerhold <NUM> be located at the <NUM> o'clock position, since the tissue thickness at the <NUM> o'clock position in the area of the pubic bone <NUM> is consistent between patients, as opposed to other positions, e.g., the <NUM> o'clock or <NUM> o'clock positions where the tissue thickness may vary between patients.

In an optional embodiment illustrated in <FIG>, multiple transvaginal stimulation devices 12a-12c having different distances d2 between the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM> may be provided (e.g., the distances d2 may range from <NUM> to <NUM>), such that the electrodes 30a, 30b of at least one of the transvaginal stimulation devices 12a-12c are axially aligned with the mid-urethral striated sphincter muscle <NUM> of the patient <NUM> when the respective transvaginal stimulation device <NUM> is properly seated within the vaginal cavity <NUM> of the patient <NUM>. Thus, one of the stimulation devices 12a-12c may be judicially selected, such that distance d2 between the electrode 30a, 30b and the waist <NUM> matches the distance between the introitus <NUM> of the vaginal cavity <NUM> (shown in <FIG>) and the mid-urethral striated sphincter muscle <NUM>.

Referring to <FIG>, another embodiment of a transvaginal stimulation device <NUM>' has a telescoping arrangement. In particular, probe body <NUM> of the transvaginal stimulation <NUM>' is divided into two telescoping proximal and distal probe bodies 42a, 42b that can be displayed relative to each other. The transvaginal device <NUM>' comprises a locking mechanism <NUM> (e.g., a collet feature or collar) that can be manipulated to lock the axial displacement between the proximal and distal probe bodies 42a, 42b to ensure that the transvaginal stimulation device <NUM>' remains at the desired length. Thus, the distance d2 between the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM> may be varied (e.g., the distances d2 may range from <NUM> to <NUM>) by displacing and then locking the proximal and distal probe bodies 42a, 42b relative to each other to match the distance between the introitus <NUM> of the vaginal cavity <NUM> (shown in <FIG>) and the mid-urethral striated sphincter muscle <NUM>, thereby facilitating axial alignment between the electrodes 30a, 30b and the mid-urethral striated sphincter muscle <NUM> of the patient <NUM> when the respective transvaginal stimulation device <NUM>' is properly seated within the vaginal cavity <NUM> of the patient <NUM>.

Referring to <FIG>, still another embodiment of a transvaginal stimulation device <NUM>" comprises moveable electrodes 32a, 32b having mechanically variable axial locations, such that the electrodes 32a, 32b may be axially aligned with the periurethral structural components of the patient <NUM>. For example, the transvaginal stimulation device <NUM>" may have interfacing features, such as a J-channel <NUM> between the electrodes 32a, 32b and the probe body <NUM> that allows the electrodes 32a, 32b to be incrementally adjusted and locked in the axial direction relative to the probe body <NUM>, e.g., every <NUM>. Thus, the distance d2 between the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM> vary be varied (e.g., the distances d2 may range from <NUM> to <NUM>) by displacing and locking the electrodes 32a, 32b to match the distance between the introitus <NUM> of the vaginal cavity <NUM> (shown in <FIG>) and the mid-urethral striated sphincter muscle <NUM>, thereby facilitating axial alignment between the electrodes 30a, 30b and the mid-urethral striated sphincter muscle <NUM> of the patient <NUM> when the respective transvaginal stimulation device <NUM>" is properly seated within the vaginal cavity <NUM> of the patient <NUM>.

Although each of the transvaginal stimulation devices <NUM>, <NUM>', and <NUM>" illustrated in <FIG> has a single pair of electrodes 30a, 30b, yet another embodiment of a transvaginal stimulation device <NUM>‴ may comprise a pair of linear arrays of electrodes 30a(<NUM>)-(<NUM>), 30b(<NUM>)-(<NUM>), as illustrated in <FIG>. Significantly, pairs of electrodes 30a(<NUM>)-(<NUM>), 30b(<NUM>)-(<NUM>) may be activated, such that the location of stimulation along the urethra <NUM> can be cranio-caudally varied, even though the physical location of the transvaginal stimulation device <NUM>, and the electrodes 30a(<NUM>)-(<NUM>), 30b(<NUM>)-(<NUM>), is fixed in the vaginal cavity <NUM> of the patient <NUM>.

A pair of electrodes 30a(<NUM>)-(<NUM>), 30b(<NUM>)-(<NUM>) may be selectively activated to craniocaudally vary the location (either proximally or distally) of stimulation along the urethra <NUM>. It is preferred that any selected pair of electrodes be activated as transverse (i.e., displaced from each other along the transverse axis) bipolar electrode combinations; i.e., the electrodes in one of the electrode arrays L, R be activated as anodes, and the electrodes in the other of the electrode arrays L, R be activated as cathodes, thereby providing the most effective bipolar stimulation to the circumferential striated muscle <NUM>.

For example, as illustrated in <FIG>, different traverse bipolar pairs of electrodes in the linear array of electrodes 30a(<NUM>)-(<NUM>), 30b(<NUM>)-(<NUM>) (respectively designated "L1-L3" and "R1-R3") can be activated to vary the location of stimulation relative to the urethra <NUM> in order to focus the stimulation over the circumferential striated muscle <NUM>. For example, one transverse bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L1 versus electrode R1) may be activated for a more cranial stimulation location (i.e., a more caudally located mid-urethral striated sphincter muscle <NUM>), as illustrated in <FIG>; another transverse bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L2 versus electrode R2) may be activated for a medial stimulation location, as illustrated in <FIG>; and still another transverse bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L3 versus electrode R3) may be activated for a more caudal stimulation location, as illustrated in <FIG>.

In an optional technique, the different transverse bipolar pairs of electrodes L1-L3, R1-R3 may be cycled to actively move the stimulation location in the cranial-caudal direction relative to the urethral <NUM> by sequentially activating transverse bipolar electrode pairs in a wave in a single stimulation regimen. For example, the transverse bipolar electrode pairs may be sequentially activated in the caudal direction (e.g., by activating electrode L1 versus electrode R1, then electrode L2 versus electrode R2, and then electrode L3 versus electrode R3) and/or in the cranial direction (by activating electrode L3 versus electrode R3, then electrode L2 versus electrode R2, then electrode L3 versus electrode R3). The transverse bipolar pairs of electrodes L1-L3, R1-R3 may be activated in any order, and one pair of electrodes may be activated more or less than another transverse bipolar pair of electrodes, as long as each electrode pair is activated at least once in the single stimulation regimen.

While it is believed that specifically targeting the mid-urethral striated sphincter muscle <NUM> for stimulation is the most effective way to treat SUI of the patient <NUM>, it should be appreciated that there may be circumstances where supplemental stimulation of other periurethral structural components of the patient <NUM> (e.g., the circumferential smooth muscle <NUM> and/or the longitudinal smooth muscle <NUM>) may be desirable. In this case, the stimulation regimen may not be limited to the activation of a single transverse pair of electrodes 30a, 30b in a bipolar fashion.

In one embodiment, transverse multipolar subsets of electrodes L1-L3, R1-R3 may be activated, as illustrated in <FIG>, thereby providing the most effective stimulation to both the circumferential striated muscle <NUM> and the circumferential smooth muscle <NUM>. For example, two electrodes in the linear electrode array L may be activated with one polarization, and two electrodes in the linear electrode array R may be activated with another polarization (e.g., by activating electrodes L1 + L2 versus electrodes R1 + R2, as shown in <FIG>, or by activating electrodes L2 + L3 versus electrodes R2 + R3, as shown in <FIG>). As another example, three electrodes in the linear electrode array L may be activated with one polarization, and three electrodes in the linear electrode array R may be activated with another polarization (in this case, by activating electrodes L1 + L2 + L3 versus electrodes R1 + R2 +R3), as shown in <FIG>.

In another embodiment, longitudinal (i.e., displaced from each other along the longitudinal axis) multipolar subsets of electrodes L1-L3, R1-R3 may be activated, as illustrated in <FIG>, thereby providing the most effective stimulation to the longitudinal smooth muscle <NUM>. For example, one longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode L1 versus electrode L2) may be activated, as illustrated in <FIG>; another longitudinal bipolar pair of electrodes in the linear electrode array R (e.g., electrode R1 versus electrode R2) may be activated, as illustrated in <FIG>; still another longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode L2 versus electrode L3) may be activated, as illustrated in <FIG>; yet another longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode R2 versus electrode R3) may be activated, as illustrated in <FIG>; yet another longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode L1 versus electrode L3) may be activated, as illustrated in <FIG>; and yet another longitudinal bipolar pair of electrodes in the linear electrode array R (e.g., electrode R1 versus electrode R3) may be activated, as illustrated in <FIG>. As another example, two electrodes respectively in the linear electrode arrays L, R may be activated with one polarization, and two electrodes in the linear electrode arrays L, R may be activated with another polarization (e.g., by activating electrodes L1 + R1 versus electrodes L2 + R2, as shown in <FIG>, or by activating electrodes L1 + R1 versus electrodes L3 + R3, as shown in <FIG>).

Although bipolar pairs of electrodes have been illustrated as being orthogonal (horizontally and vertically disposed), bipolar pairs of electrodes may be diagonally disposed relative to each other. For example, one diagonal bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L1 versus electrode R3) may be activated, as illustrated in <FIG>; and another diagonal bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L3 versus R1) may be activated, as illustrated in <FIG>.

Having described the structure and function of the SUI treatment system <NUM>, one method <NUM> of using the SUI treatment system to treat SUI in the patient <NUM> will now be described. Referring to <FIG>, the transvaginal stimulation device <NUM> (or alternatively, any of the transvaginal stimulation devices <NUM>, <NUM>", or <NUM>") is inserted into the vaginal cavity <NUM> of the patient <NUM>, such that scoop <NUM> conforms to the posteriorly angled cranial end of the vaginal cavity <NUM> when the probe body <NUM> is fully disposed in the vaginal cavity <NUM>, and the levator ani muscles <NUM> of the female patient <NUM> are disposed adjacent to the mid-region <NUM> between the flattened scoop <NUM> and the shoulders <NUM>, as illustrated in <FIG>, <FIG> and <FIG> (step <NUM>). Thus, the transvaginal stimulation device <NUM> will be securely seated and retained within the vaginal cavity <NUM>, while the stimulating side 52a of the probe body <NUM> of the transvaginal stimulation device <NUM> contacts the anterior wall <NUM> of the vagina <NUM>, such that the electrodes 30a, 30b face the urethra <NUM>. Proper seating and orientation of the transvaginal stimulation device <NUM> can be confirmed by approximating the pubic bone <NUM> of the female patient <NUM> with the proximal surface of the fingerhold <NUM> of the extraction mechanism <NUM>.

Next, the transvaginal stimulation device <NUM> is mechanically and/or electrically fitted to the patient <NUM> to optimize treatment of the SUI (step <NUM>). As stated above, maximum urethral closure pressure of a patient can be considered a good measure of optimized SUI treatment. As such, biofeedback in the form of urethral closure pressure measurements of the patient <NUM> can be used while mechanically and/or electrically fitting transvaginal stimulation device <NUM> to the patient <NUM>, such that one or more stimulation regimens (defining the stimulation parameters and axial electrode placement relative to the mid-urethral striated sphincter muscle <NUM> of the patient <NUM> (see <FIG>)) can be determined. In general, it is desirable to select stimulation regimens that achieve a sufficient maximum closure pressure, while minimizing the current density on the electrodes 30a, 30b.

As one example of fitting the transvaginal stimulation device <NUM>, the clinician programmer <NUM> may be operated to convey electrical stimulation energy from the electrodes 30a, 30b of the inserted transvaginal device <NUM>, while varying any one or more electrical stimulation parameters (e.g., varying the pulse width in the range of <NUM> - <NUM> and/or varying the pulse frequency in the range of <NUM> - <NUM> and/or varying the magnitude in the range of <NUM> mA - <NUM> mA), to define one or more efficacious stimulation programs.

In the case where different sized transvaginal stimulation devices <NUM> are available (<FIG>), each different transvaginal stimulation device <NUM> may be inserted into the vaginal cavity <NUM> of the patient <NUM> to determine the optimally sized transvaginal stimulation device <NUM>. For example, the transvaginal stimulation device <NUM> having the proper distance between the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM>, such that the electrodes 30a, 30b are coincident with the mid-urethral striated sphincter muscle <NUM> (i.e., the transvaginal stimulation device <NUM> that results in maximum urethral closure pressure) may be selected.

In the case where the telescoping transvaginal stimulation device <NUM> is used (<FIG>), the proximal and distal body portions 42a, 42b may be axially displaced relative to each other to vary the distance between the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM>, such that the electrodes 30a, 30b are coincident with the mid-urethral striated sphincter muscle <NUM> (i.e., the transvaginal stimulation device <NUM> that results in maximum urethral closure pressure). The locking mechanism <NUM> can then be locked to affix the electrodes 30a, 30b relative to the probe body <NUM>.

In the case where the transvaginal stimulation device <NUM>" is used (<FIG>), the electrodes 30a, 30b may be axially adjusted relative to the probe body <NUM> to vary the distance between the electrodes 30a, 30b and the waist <NUM> of the probe body <NUM>, such that the electrodes 30a, 30b are coincident with the mid-urethral striated sphincter muscle <NUM> (i.e., the transvaginal stimulation device <NUM> that results in maximum urethral closure pressure).

In the case where the transvaginal stimulation device <NUM>" is used (<FIG>), different pairs of the electrode 30a, 30b can be activated to determine the pair of electrodes 30a, 30b that is coincident with the mid-urethral striated sphincter muscle <NUM> (i.e., the transvaginal stimulation device <NUM> that results in maximum urethral closure pressure). The clinician programmer <NUM> may be operated to automatically sequence through various combinations of electrode pairs and other electrical stimulation parameters while maintaining the electrical current at an effective, but comfortable, level, e.g., in the range of <NUM> mA - <NUM> mA. The frequency of the electrical stimulation energy may have a range of, e.g., <NUM> - <NUM>.

Next, the clinician programmer <NUM> is operated to program the transvaginal stimulation device <NUM> with optimized stimulation program(s) (defining the location of the electrodes 30a, 30b in the case of the transvaginal stimulation device <NUM>", as well as the pulse width, pulse frequency, and pulse amplitude (step <NUM>). The transvaginal stimulation device <NUM> may then be operated to initiate stimulation session by transvaginally conveying electrical stimulation energy uni-directionally through the anterior wall <NUM> of the vagina <NUM> in accordance with one or more stimulation programs. For example, the patient <NUM> may operate the patient controller <NUM> (or alternatively, the minimal UI <NUM>) to activate the transvaginal stimulation device <NUM> and select the stimulation program(s). During the stimulation session, the mid-urethral striated sphincter muscle <NUM> is stimulated to treat the SUI of the patient <NUM> without substantially stimulating pelvic floor muscles of the patient <NUM> (step <NUM>). The transvaginal stimulation device <NUM> may then automatically terminate the stimulation session, e.g., in accordance with a predetermined cycle (step <NUM>). Alternatively, the transvaginal stimulation device <NUM> may be manually terminated, e.g., by operating the patient controller <NUM> (or alternatively, the minimal UI <NUM>) to deactivate the transvaginal stimulation device <NUM>. It is contemplated that the patient <NUM> will require approximately <NUM> minutes of treatment time every day for at least <NUM> - <NUM> weeks to hypertrophy the periurethral structural components, and more particularly, the mid-urethral striated sphincter muscle <NUM>.

Claim 1:
A transvaginal stimulation device (<NUM>), comprising:
a probe body (<NUM>) sized to fit entirely within a vaginal cavity (<NUM>) of a female patient, the probe body (<NUM>) having a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth extending perpendicular to the length and width, the probe body (<NUM>) having a stimulating side (52a) defined by the length and the width of the probe body (<NUM>), the probe body (<NUM>) having a pair of convex regions longitudinally extending along the stimulating side (52a) of the probe body (<NUM>), and a concave region (<NUM>) longitudinally extending along the stimulating side (52a) of the probe body (<NUM>) between the pair of convex regions; and
a pair of electrodes (30a, 30b) respectively disposed on peaks of the pair of convex regions of the probe body (<NUM>) and laterally spaced from each other, such that the concave region (<NUM>) is disposed between the pair of electrodes (30a, 30b).