Patent Description:
The present invention, in some embodiments thereof, relates to health care and, more particularly, but not exclusively, to devices and methods for ameliorating fecal incontinence in women.

Fecal incontinence, also called a bowel control problem, is the accidental passing of solid or liquid stool or mucus from the rectum. Fecal incontinence includes the inability to hold a bowel movement until reaching a toilet as well as passing stool into one's underwear without being aware of it happening. Fecal incontinence has many causes, including: diarrhea, constipation, muscle damage or weakness, nerve damage, loss of stretch in the rectum, childbirth by vaginal delivery, hemorrhoids and rectal prolapse, rectocele (protrusion of the rectum through the vagina), and inactivity.

Previous attempts at treating fecal incontinence include: medications, dietary changes, exercise (biofeedback, bowel training, sacral nerve stimulation, posterior tibial nerve stimulation), vaginal balloons, and surgery (sphincteroplasty, sphincter replacement, sphincter repair, colostomy, surgical repair of rectal prolapse or rectocele or hemorrhoids).

Vaginal balloons are currently the only substitutional treatment to surgical procedures. However, vaginal balloons have several deficiencies, such as the need for inflation tube, lack of effective stable support, etc..

Background art includes the following patents:.

There is provided in aspect of the invention, a fecal incontinence device for insertion into a vagina, comprising: a plurality of shell segments, which together form an enclosed cylinder with rounded ends in a collapsed state of the device, wherein one of the cylindrical shells is disposed in the device facing a posterior wall of the vagina when the device is inserted into the vagina; a pressure generating structure attached to and abutting the posterior-facing cylindrical shell, and, a state-changing mechanism configured to reversibly transition the device from the collapsed state to an expanded state.

In the invention, the device further comprises an applicator, removable from the device, inserted into the enclosed cylinder and configured to activate the state-changing mechanism to transition the device from the collapsed state to the expanded state.

In an embodiment of the invention, there are two hemispherical shell segments, an upper shell segment and the posterior-facing shell segment, and the pressure generating structure is a bulge located on the exterior surface of the posterior-facing cylindrical shell.

In an embodiment of the invention, there are three or more shell segments, including the posterior-facing shell segment, and the pressure generating structure is a reversibly extendible pressure pole which is configured to be retracted within the shell segment when the device is in the collapsed state and extended when the device is in the expanded state.

In an embodiment of the invention, the pressure pole is at least one of extended and retracted by at least one of magnetic and mechanical force.

In an embodiment of the invention, the degree of extension of the pressure pole is controlled by at least one of magnetic field intensity and reversibly locking integral snaps located in the posterior-facing shell segment.

In an embodiment of the invention, the pressure pole is at least one of extended and retracted by a worm gear.

In an embodiment of the invention, the state-changing mechanism includes an actuator connected to a rack by a detachable holder and where the rack is operatively connected to at least one threaded pole by a plurality of cog wheels, wherein the actuator is configured to move coaxially in the holder, and wherein movement of the actuator in a distal direction causes movement of the shell segments towards the expanded state of the device and movement of the actuator in a proximal direction causes movement of the shell segments towards the collapsed state of the device.

In an embodiment of the invention, one of the plurality of cylindrical shells is configured with at least one fender configured to stabilize the fecal incontinence device in an anterior-posterior intra vaginal arrangement.

In an embodiment of the invention, the state-changing mechanism includes a holder, in contact with a central tube having a hinged connection with at least one arm for each of the shell segments, and a puller.

In an embodiment of the invention, the puller has a plurality of pulling rods with bulges that are attached to a slider which also has hinged connection with each arm of the shell segments, wherein when the holder is pushed in a proximal direction, the pulling rods pull the slider over the central tube in a distal direction thus shortening the distance between the slider and the hinged connection, changing the state of the device from the collapsed state to the expanded state.

In an embodiment of the invention, the device further comprises press blocks of an inner rotating mechanism on both sides of the puller wherein the press blocks push the bulges on the pulling rods which causes the pulling rods to rotate, aligning the pulling rods with an opening in the slider, and allowing detachment of the pulling rods from the slider.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: an outer shell cylindrically shaped and rounded on both ends; a plurality of front support arms hingedly attached to the outer shell and configured to anchor the device; a plurality of rear arms hingedly attached to the outer shell and configured to support the device, wherein at least one of the rear arms is further configured to apply rectal pressure; and, a state-changing mechanism configured to transition the device from a collapsed state to an expanded state, wherein the front support arms and the rear arms lie flush to an exterior surface of the outer shell when the device is in the collapsed state.

In an embodiment of the invention, the state-changing mechanism comprises a central activation shaft with tapered surfaces and where each of the front support arms and the rear arms has a free edge in contact with one of the tapered surfaces such that when the shaft is moved proximally the shaft forces the front support arms and the rear arms to rotate around their hinges and transition the device from the collapsed state to the expanded state.

In an embodiment of the invention, the tapered surfaces have a different angle for the rear arms than for the front support arms, resulting in a different range of motion for the rear arms with respect to the front support arms.

In an embodiment of the invention, the device further comprises an applicator including a holder and a pusher, where the pusher moves axially within the holder.

In an embodiment of the invention, the pusher is in contact with the activation shaft such that pushing the pusher distally causes movement of the activation shaft distally, opening the front support arms and the rear arms outwards and into the expanded state.

In an embodiment of the invention, the holder has two sets of snaps situated on grooves at a front end of the device, such that snaps prevent the device from moving distally during insertion of the device into the vagina.

In an embodiment of the invention, the applicator is configured to be rotatable around a longitudinal axis of the device, and wherein the snaps are configured to be bendable by rotation of the applicator, releasing them from the slots and allowing for removal of the applicator.

In an embodiment of the invention, the device further comprises a plurality of locking snaps on the activation shaft that snap into slots on the device and prevent the activation shaft from moving in the distal direction, keeping the front support arms and the rear arms opened and the device in the expanded state.

In an embodiment of the invention, there is a plurality of slots that allow locking of the activation shaft in several positions, thus creating multiple expansions options for the front support arms and the rear arms.

In an embodiment of the invention, there are <NUM> or more of each of the front support arms and the rear arms.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: a plurality of support arches; and at least one rectum pressing element.

In an embodiment of the invention, the device further comprises a locking mechanism configured to reversibly lock at least one of the plurality of support arches and the at least one rectum pressing element in an open configuration.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: a main body configured for insertion in a sagittal plane of a vagina; a rectum pressing element on the bottom of the main body; and a curved fin opposite the rectum pressing element on the main body.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: at least one set, including, an upper pole element; and a lower pole element attached to the upper pole element, wherein the upper pole element and the lower pole element are configured to move apart with respect to each other to reversibly place the device into an expanded state.

In an embodiment of the invention, the device further comprises a plurality of sets, the sets connected by at least one connection bar.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: a support ring part, configured to stabilize the device in a vagina when expanded; and, a rectal pressing part, configured for reversible attachment to the support ring part and for applying pressure to the rectum when expanded.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: a support ring; an angularly activated rectum pressing element, shaped to anchor the device adjacent and configured to apply pressure to the rectum when in an expanded state.

There is further provided in aspect of the invention, a fecal incontinence device, comprising: a rectum pressing element configured with a bulge to apply pressure to the rectum when the device is in an expanded state; and, an anchoring element, configured with a saddle for cupping a urethra to prevent direct pressure on the urethra when the device is in an expanded state.

In an embodiment of the invention, the device further comprises at least one side stabilizer.

In an embodiment of the invention, the device further comprises a locking mechanism.

In an embodiment of the invention, the device further comprises an applicator.

In an embodiment of the invention, the applicator is configured with a biased handle.

In an embodiment of the invention, the device further comprises a removal string.

In an embodiment of the invention, a removal string is connected to the worm gear and pulling on the string causes the worm gear to transition the device back to the collapsed state.

In an embodiment of the invention, a removal string is connected to the locking snaps such that pulling on the removal string bends the locking snaps inwards and releasing the locking snaps from the slots, transforming the device back to the collapsed state.

In an embodiment of the invention, the device further comprises an outer soft layer.

In an embodiment of the invention, the device is configured to gradually transition from the collapsed state to the expanded state such that the transition may be stopped at a plurality of different expanded device sizes.

There is further provided in an aspect of the invention, a fecal incontinence device, comprising: a plurality of shell segments, which together form an enclosed cylinder with rounded ends in a collapsed state of the device, wherein one of the cylindrical shells is disposed in the device facing a posterior wall of the vagina when the device is inserted into the vagina; a pressure generating structure attached to and abutting the posterior-facing cylindrical shell; and, a state-changing mechanism configured to reversibly transition the device from the collapsed state to an expanded state, wherein the state-changing mechanism includes a puller and a holder, the holder in contact with a central tube having a hinged connection with two equally sized arms for each of the shell segments, except the posterior-facing shell segment which has one arm shorter than the equally sized arms and one arm longer than the equally sized arms, such that when the device transitions to the expanded state, the posterior-facing shell segment expands in an angled relationship to a longitudinal axis of the device.

With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example, and not necessarily to scale, and are for purposes of illustrative discussion of embodiments of the invention.

The present invention, in some embodiments thereof, relates to health care and, more particularly, but not exclusively, to devices for ameliorating fecal incontinence in women.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. It should also be understood that as used herein, "proximal" or "proximally" means closest to the vaginal introitus or in a direction towards the outside of the patient's body and "distal" or "distally" means closest to the cervix or in direction moving further inside the patient's body. Description of devices herein, when referencing proximal or distal directions, is in the context of third person's view of a deployed device in a patient's vagina. For example, the distal end of a device is the end closest to the cervix (farthest into the patient) when the device is inserted into the patient.

<FIG> are perspective views of a <NUM>-arch fecal incontinence device <NUM> with applicator <NUM>, according to exemplary embodiments of the invention. As shown in <FIG>, the device <NUM> is configured to transform from a collapsed state <NUM> to an expanded state <NUM>. In some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and/or removal from a patient's vagina. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion to render support to the rectum.

In an embodiment of the invention, the fecal incontinence device <NUM> comprises at least two side arches <NUM> and a rectum pressuring element/arch <NUM>. In some embodiments, side arches <NUM> are configured for anchoring the device bilaterally within the vagina. In some embodiments, the rectum pressuring arch <NUM> is configured to apply posterior force when the device <NUM> is deployed in the vagina, thereby pressing the rectum. In some embodiments of the invention, the arches <NUM>, <NUM> are covered by an elastic material layer <NUM>, <NUM> (shown in <FIG>) that serves as padding to reduce pressure on the vaginal tissue and/or enhance patient comfort.

The arches <NUM>, <NUM> are connected to an external tube <NUM> at the distal end of the device <NUM> and an internal tube <NUM> at a proximal end of the device <NUM>. In other words, in an embodiment, the top ends (distal ends) <NUM>, <NUM> of the arches <NUM>, <NUM> are attached to the external tube <NUM> and the proximal ends <NUM>, <NUM> of the arches <NUM>, <NUM> are attached to an internal tube <NUM>. In some embodiments, the internal tube <NUM> is coaxially mounted within the external tube <NUM> to enable telescoping between the tubes <NUM>, <NUM>. In an embodiment of the invention, telescoping means the internal tube <NUM> slides within the external tube <NUM> to adjust the overall length of the device <NUM> and/or the degree of bending of the arches <NUM>, <NUM>. It should be understood that while the tubes <NUM>, <NUM> are called "tubes" which would imply a cylindrical shape, they are not necessarily cylindrical. For example, external tube <NUM> may have a square shaped cross-sectional profile.

<FIG> is a perspective view of the applicator <NUM>, in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion of the device <NUM> into a vagina and/or for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>). In an embodiment of the invention, the applicator <NUM> comprises a holder <NUM>, a pusher <NUM> and/or a gripping area <NUM>.

In an embodiment of the invention, the holder <NUM> is attached to the device <NUM> by two protruding teeth <NUM> that are situated in retaining slots <NUM> in the external tube <NUM>, shown and described in more detail with respect to <FIG>. The holder <NUM> and pusher <NUM> are configured to allow axial movement of the pusher <NUM> relative to the holder <NUM>, where the pusher <NUM> moves axially within the holder <NUM>. Pushing the pusher <NUM> causes the proximal end of the device <NUM> to move towards the distal end of the device <NUM> and the protruding teeth <NUM> prevent the external tube <NUM> from moving, thereby shortening its overall length and causing an outward bowing or expansion of the arches <NUM>, <NUM>.

Pressing the pusher <NUM> situates the internal tube <NUM> in a position that separates the holder's protruding teeth <NUM> from the outer tube's retaining slots <NUM> (leaving the device in situ). In an embodiment of the invention, when the applicator <NUM> is removed, the removal string's <NUM> distal end extends outside the vagina (similar to a regular menstrual tampon).

To remove the pessary from the vagina, in an embodiment of the invention, the removal string <NUM> connected to a snapping element <NUM> is pulled, thus becoming slightly elongated and narrower, with its <NUM> arms contracted inwards, thereby releasing the locking mechanism. Unlocking the locking mechanism allows the device <NUM> to transform from the expanded state <NUM> back to the collapsed state <NUM> for easier removal which is achieved by a sustained proximal tension on the removal string <NUM>.

<FIG> is a cross-sectional view of the device <NUM> in the expanded mode <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the external tube <NUM> has slots <NUM> and the internal tube <NUM> has a snapping element <NUM> that protrudes from the inner tube <NUM> wherein the snapping element <NUM> is configured to be removably inserted into the slots <NUM>. The snapping element <NUM>, shown in <FIG>, serves as a locking mechanism by contracting inwards when encountering the external tube <NUM> (when transforming from the collapsed state <NUM> to the expanded state <NUM>) and moving back to its original position in the slots <NUM>, thus locking the device <NUM> in its expanded state and preventing the external tube <NUM> from returning to its original position (collapsed state <NUM>).

In an embodiment of the invention, the arches <NUM>, <NUM> are chainlike, made of several links <NUM>, <NUM> allowing for arch flexibility, yet stability when locked. <FIG> is a detailed view of two links <NUM> that form the support arches <NUM>, in some embodiments of the invention.

<FIG> is a detailed view of two links <NUM> that form the rectum pressuring arch <NUM>. In an embodiment of the invention, the rectum pressuring arch <NUM> is configured to stabilize the device <NUM> with respect to the rectum, for example by being provided with a curved surface which conforms to the natural anatomical features of the posterior wall of the vagina adjacent to the rectum.

In some embodiments of the invention, at least one of the links <NUM>, <NUM> has a cover <NUM> for providing protection to the inner surfaces of the vagina and/or enhancing patient comfort.

<FIG> are perspective views, collapsed and open, respectively, of a <NUM>-arch fecal incontinence device <NUM> with a snapping teeth mechanism, according to an exemplary embodiment of the invention. In some embodiments, the device <NUM> comprises at least two support arches <NUM> and a bendable rectal arch <NUM>, which is configured to abut and to apply posterior force on the rectum from within the vagina. In some embodiments, the support arches <NUM> anchor the device <NUM> bilaterally within the vagina. An applicator <NUM> is attached to an external tube <NUM>, in accordance with an exemplary embodiment of the invention. As shown in <FIG>, the device <NUM> is configured to transform from a collapsed state <NUM> to an expanded state <NUM>. In some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and/or removal from the vagina. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion.

In an embodiment of the invention, a proximal end <NUM> of the bendable rectal arch <NUM> is attached to an inner telescopic element <NUM>. A distal end <NUM> of the bendable rectal arch <NUM> is attached to an external tube <NUM>. The inner telescopic element <NUM> is coaxial with the external tube <NUM> and a support tube <NUM>.

In some embodiments of the invention, proximal ends of the support arches <NUM> are attached to the support tube <NUM> and the distal ends of the support arches <NUM> are attached to the external tube <NUM>.

<FIG> is a top cross-sectional view of the open <NUM>-arch fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. The support tube <NUM> has inwards snapping teeth <NUM>, in an embodiment of the invention. A locking tube <NUM> is positioned coaxially with the external tube <NUM>, support tube and inner telescopic element <NUM>, in an embodiment. The locking tube <NUM> is situated between the inner telescopic element <NUM> and the support tube <NUM>. Pushing the support tube <NUM> in the distal direction snaps the snapping teeth <NUM> into slots in the locking tube <NUM>, thus locking the support arches <NUM>.

The inner telescopic element <NUM> can be moved separately inside the locking tube <NUM> allowing the bendable rectal arch <NUM> to have a different distance between its proximal end <NUM> and its distal end <NUM> than that of the support arches <NUM>. The inner telescopic element <NUM> has a snapping element <NUM>, in an exemplary embodiment of the invention. Pushing the inner telescopic element <NUM> in the distal direction snaps the snapping element <NUM> into slots in the locking tube <NUM>, thus locking the rectal arch <NUM>.

In another embodiment of the invention, the bendable rectal arch <NUM> can have multiple snapping elements <NUM>, such as shown in <FIG>. In some embodiments, the bendable rectal arch <NUM> can be locked at various distances between its proximal end <NUM> and its distal end <NUM> allowing the user to control the distance between its proximal end <NUM> and its distal end <NUM>, thereby controlling the force applied on the rectum.

<FIG> are perspective and cross-sectional views, respectively, of the applicator <NUM> of the open <NUM>-arch fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion the device <NUM> into a vagina and for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>). In an embodiment of the invention, the applicator <NUM> comprises a holder <NUM>, a support pusher <NUM> and a rectal support pusher <NUM>. In some embodiments, the holder <NUM> is attached to the device <NUM> by protruding teeth <NUM> with holding pins <NUM> that function as retaining walls to counter on the outer tube <NUM> and prevent it from moving during compression.

The holder <NUM>, support pusher <NUM> and rectal support pusher <NUM> are configured to allow axial movement of the pushers <NUM>, <NUM> relative to the holder <NUM> and to each other, where the pushers <NUM>, <NUM> move axially within the holder <NUM>. In an embodiment of the invention, pushing the rectal support pusher <NUM> causes the proximal end of the rectal arch <NUM> to move towards the distal end, thereby shortening its overall length and causing an outward bowing or expansion of the rectal support arch <NUM>. At the same time, the rectal support pusher <NUM> also pushes the support pusher <NUM> towards the distal end of the device <NUM>, thereby shortening the overall length causing an outward bowing or expansion of the support arch <NUM>.

In the holder <NUM> there is a leading canal <NUM> that directs the movement of the support tube <NUM> via a leading pin <NUM> on the support pusher. After the support arches are fully locked, the leading canal <NUM> causes rotation of the support pusher <NUM>, this rotation disconnects the support pusher <NUM> from the rectal support pusher <NUM> and allows for the rectal support pusher to continue moving distally (without further pushing the locked support arches <NUM>).

Once the support arches <NUM> are locked, and the rectal support arch <NUM> is also locked, the applicator <NUM> is released from the device <NUM> by rotation of the applicator <NUM>. The rotation causes disconnection between the protruding teeth <NUM> and protrusions on the external tube <NUM>. In an embodiment of the invention, when the applicator <NUM> is removed, a removal string's <NUM> proximal end extends outside the vagina (similar to a regular menstrual tampon), the removal string <NUM> shown in <FIG>.

To remove the device <NUM> from the vagina, in an embodiment of the invention, the removal string <NUM> connected to the locking tube <NUM> is pulled, thus bending the snapping teeth <NUM> and snapping element <NUM> inwards, releasing the locking mechanism. Unlocking the locking mechanism allows the device <NUM> to transform from the expanded state <NUM> back to the collapsed state <NUM> for easier removal which is achieved by a sustained proximal tension on the removal string <NUM>.

<FIG> are perspective views, collapsed and open, respectively, of a <NUM>-arch fecal incontinence device <NUM> with a pen toggle mechanism, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> comprises at least two support arches <NUM> and a bendable rectal arch <NUM>. In some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and/or removal from the vagina. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion. The device comprises at least two bendable support arches <NUM> used for anchoring the device bilaterally within the vagina, and a third bendable rectal arch <NUM> used for applying posterior force, thereby pressing the rectum.

<FIG> is a cross-sectional view of the <NUM>-arch fecal incontinence device <NUM> with a pen toggle mechanism (shown in more detail in <FIG>), according to an exemplary embodiment of the invention. In an embodiment of the invention, <FIG> shows an activation mechanism of the bendable rectal arch <NUM>. A distal end <NUM> of the bendable rectal arch <NUM> is attached to an inner telescopic element <NUM>. A proximal end <NUM> of the bendable rectal arch <NUM> is attached to the inner support tube <NUM>. In some embodiments, the inner telescopic element <NUM> is coaxial with the inner support <NUM> and external support tube <NUM>. In an embodiment of the invention, proximal ends of the support arches <NUM> are attached to the external support tube <NUM> and distal ends are attached to the inner support tube <NUM>.

<FIG> is an exploded view of a "pen toggle mechanism" <NUM> used for toggling of the inner telescopic element <NUM> between two or more positions. The toggle mechanism is composed of a rotator tube <NUM> with guide fins <NUM> contacting the inner telescopic element <NUM>, a spring <NUM> (<FIG>) that presses the inner telescopic element against the rotator tube <NUM>, mechanism tube <NUM> with guiding slots <NUM> and a crowned toggle <NUM> connected to a pulling string <NUM> (<FIG>). The inner telescopic element <NUM>, rotator tube <NUM> and mechanism tube <NUM> are coaxial. Pushing the inner telescopic element <NUM> in the distal direction causes the rotator tube <NUM> to move in the distal direction as well. Pulling the rotator tube <NUM> in the proximal direction (by a pull of the pulling string <NUM>) causes the inner telescopic element <NUM> to move in the proximal direction as well.

When pulling the pulling string <NUM>, the crowned toggle <NUM> slides within the mechanism tube's slots <NUM> and pushes the rotator tube <NUM> in the proximal direction, thus the inner telescopic element <NUM> is pushed in the proximal direction. Pushing the inner telescopic element in the proximal direction compresses the spring <NUM>. Once the rotator tube <NUM> exits the mechanism tube's slots <NUM> (but not completely exiting the mechanism tube <NUM>) it rotates due to the crowned toggle <NUM> rim's shape to a position in which the guide fins <NUM> are able to slide within the mechanism tube's slots <NUM>. Thus, the rotator tube <NUM> and inner telescopic element <NUM> are pushed by the spring <NUM> causing an outward bowing or expansion and of the bendable rectal arch <NUM>. A second pull of the pulling string <NUM> causes the crowned toggle <NUM> to slide within the mechanism tube's slots <NUM> and pushes the rotator tube <NUM> in the proximal direction, thus the inner telescopic element <NUM> is pushed in the proximal direction. Pushing the inner telescopic element in the proximal direction compresses the spring <NUM>. Once the rotator tube <NUM> exits the mechanism tube's slots <NUM> (but not completely exiting the mechanism tube <NUM>) it rotates due to the crowned toggle <NUM> rim's shape to a position in which the guide fins <NUM> are unable to slide within the mechanism tube's slots <NUM>. Thus, the rotator tube <NUM> and inner telescopic element <NUM> remain in their initial position.

Toggling the "pen toggle mechanism" enables switching the bendable rectal arch <NUM> between activated and not activated positions (pressing the rectum and providing relief of the rectal pressure) while the support arches <NUM> remain in the expanded state, keeping the device <NUM> in place and allowing patient undisturbed defecation without the need to replace the device.

In an embodiment of the invention, an array of different length mechanism tube slots <NUM> can be used to obtain more than two locking positions for the third telescopic element, allowing control of the pressure on the rectum.

<FIG> are perspective and close-up views, respectively, of an interface between the <NUM>-arch fecal incontinence device <NUM> and the applicator <NUM> that is used to insert the device into the vagina and to transfer it from its collapsed state <NUM> to its expanded state <NUM>, according to an exemplary embodiment of the invention. The applicator <NUM> consists of a holder <NUM> and a pusher <NUM>. The holder <NUM> is attached by snapping elements <NUM> to snapping pins <NUM> on the device's <NUM> distal side.

The pusher <NUM> is in contact with the external support tube <NUM> (<FIG>). When the pusher <NUM> is pushed the external support tube <NUM> is moved distally until the device <NUM> reaches its expanded state <NUM> where a locking mechanism <NUM> snaps into slots <NUM> in the external support tube <NUM>. A further push of the pusher <NUM> brings the external support tube <NUM> distal rim to contact with release diagonal protrusions <NUM> on the holder <NUM> pressing the arms of the holder <NUM> outwards and disconnecting the holder's snapping elements <NUM> from the snapping pins <NUM>. The applicator <NUM> is then pulled out of the vagina leaving the device <NUM> inside the vagina and a removal string <NUM> (separate of the toggle mechanism pulling string <NUM>) with its proximal end out of the vagina.

The distal end of the removal string <NUM> is connected to the locking mechanism <NUM>. At the end of the device use the patient pulls the removal string <NUM> deforming the locking mechanism <NUM> thus causing it to snap out of the slots <NUM>, releasing the device from its expanded state <NUM> and allowing it to transfer back to its collapsed state <NUM>. A further pull of the removal string removes the device out of the vagina.

<FIG> is a perspective view showing a deployed, open <NUM>-arch fecal incontinence device <NUM> separated from the applicator <NUM> after deployment.

<FIG> is a perspective view of a cylindrical fecal incontinence device <NUM> with an applicator <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> comprises two half cylindrical shells <NUM>, <NUM> held by threaded poles <NUM> (shown and described with respect to <FIG>). In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion of the device <NUM> into a vagina and for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state (<FIG>). In some aspects of the invention, the device <NUM> is inserted into the vagina in its closed configuration <NUM>, where the two shells <NUM>, <NUM> form a tubular/cylindrical shape with rounded ends (<FIG>) and is expanded to render treatment.

The upper shell <NUM> serves to support the device against the vaginal anterior wall and may have fenders <NUM> (<FIG>) to further stabilize it in an anterior-posterior intra vaginal arrangement. The lower shell <NUM> serves as a rectal pressure unit and may have a bulge <NUM> (<FIG>) to locate and stabilize it against the rectum and the posterior vaginal wall. Both shells may have an outer soft layer to cushion against vaginal walls.

In another embodiment of the invention the upper shall <NUM> may comprise of a plurality of segments that open in different directions.

<FIG> is a partially exploded view of the applicator <NUM> used with the cylindrical fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the applicator <NUM> comprises an actuator <NUM> connected to a rack <NUM> by way of a detachable holder <NUM>. The actuator <NUM> can move coaxially within the detachable holder <NUM>. Pushing the actuator <NUM> in the distal direction causes movement of the rack <NUM> in the distal direction. Linear movement of the rack <NUM> is transformed to rotation of internal cogwheels <NUM> (<FIG>) in contact with the rack <NUM>. Rotation of the cog wheels <NUM> causes the threaded poles <NUM> to move in a vertical direction (anterior - posterior) thus gradually increasing (if the rack is moved distally) or decreasing (if the rack is moved proximally) the distance between the two half cylindrical shells <NUM>, <NUM>.

<FIG> is a close-up, perspective view of the interface of the rack <NUM> and the actuator <NUM> of the cylindrical fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. On the distal end of the actuator <NUM> there is a snapping element <NUM>. The snapping element <NUM> snaps into slots <NUM> in the rack <NUM>, thus keeping the rack <NUM> and actuator <NUM> connected.

In an embodiment of the invention after device deployment, the holder <NUM> is removed together with the actuator <NUM>. When pulling the holder <NUM> in the proximal direction the snapping element <NUM> bends inward, thus releasing the actuator <NUM> from the rack <NUM>.

In an embodiment of the invention a removal string's <NUM> (<FIG>) distal end is attached to the rack <NUM> and its proximal end hangs out of the actuator <NUM>. Removing the actuator <NUM> and holder <NUM> leaves the proximal end of the removal string <NUM> hanging out of the vagina.

Pulling the removal string <NUM> in the proximal direction will pull the rack <NUM> in the proximal direction and will cause rotation of the cog wheels <NUM> in a direction that will cause vertical movement of the shells <NUM>, <NUM> towards each other, returning the device <NUM> to it collapsed state <NUM> (<FIG>) for removal from the vagina.

<FIG> are perspective views, collapsed and open, respectively, of a <NUM>-piece, cylindrical fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> has a cylindrical shape which is comprised of three or more segments <NUM>, <NUM>. The bottom (posterior) cylindrical segment <NUM> is configured with a rectal pressure generating pole <NUM> near its distal end. As with other embodiments described herein, the device <NUM> (<FIG>) is closed during storage insertion and removal and it is expanded (<FIG>) following deployment. In an embodiment of the invention, the device expands gradually and may be stopped at any of several sizes, as desired, for example to fit the patient's vagina and/or to render effective amelioration of fecal incontinence. In some embodiments of the invention, posterior pressure is generated by device <NUM> by at least one of two mechanisms, from the volume filling nature of the three or more segments <NUM>, <NUM> and also the pressure generating pole <NUM>, described elsewhere herein.

<FIG> is an isometric view of the device <NUM> with two segments <NUM> shown. In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion of the device <NUM> into a vagina and/or for expanding the device <NUM>. The applicator <NUM> includes a holder <NUM> and a puller <NUM>. The holder <NUM> is in contact with a central tube <NUM> having a hinged connection <NUM> with at least one arm <NUM> for each of the segments <NUM>, <NUM>.

In an embodiment of the invention, the puller <NUM> has three pulling rods <NUM> that are attached to a slider <NUM> which also has hinged connection with at least one arm <NUM> for each of the cylindrical segments <NUM>, <NUM>. When the holder <NUM> is pushed in the proximal direction the pulling rods <NUM> pull the slider <NUM> over the central tube <NUM> in the distal direction thus shortening the distance between the slider <NUM> and the hinged connection <NUM>. Since each set of arms <NUM> is (rotationally) connected to a cylindrical segment <NUM>, <NUM> in hinged connections <NUM> (<FIG>), the angle between the arms is getting smaller causing the cylindrical segments <NUM>, <NUM> to distance from the central tube <NUM> and thus gradually expand the device <NUM>, such as shown in <FIG>.

<FIG> are cross-sectional views showing the applicator <NUM> disconnecting from the <NUM>-piece, cylindrical fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, on both sides of the puller <NUM> there are press blocks <NUM> of an inner rotating mechanism. When pushed inwards, the press blocks <NUM> push bulges <NUM> on the pulling rods <NUM> which cause the pulling rods <NUM> to rotate. Rotation of the pulling rods <NUM> brings their bent proximal ends to alignment with opening in the slider <NUM>, thus allowing detachment from the slider <NUM> and allowing for the removal of the applicator <NUM>.

<FIG> are perspective views and <FIG> are cross-sectional views of the central tube <NUM>, the slider <NUM> and the lock ring <NUM> in locked and released states, respectively. Removal of the device <NUM> from the vagina is carried out by pulling a removal string <NUM> connected to the lock ring <NUM> with openings <NUM>. The lock ring <NUM> prevents the slider <NUM> from moving proximally over the central tube <NUM> (which would cause device collapse) by supporting the central tube's snaps <NUM> (<FIG>). The removal string <NUM> is connected to the lock ring <NUM> at the side connection holes <NUM>. The side connection holes <NUM> are not aligned with the removal string's <NUM> exit holes <NUM> from the central tube <NUM>. Pulling of the removal string <NUM> causes the connection holes <NUM> and exit holes <NUM> to align therefor rotating the lock ring <NUM>. When the lock ring <NUM> rotates the openings <NUM> are aligned with the snaps <NUM> (<FIG>), thus the slider <NUM> is no longer prevented from moving proximally over the central tube <NUM> and the device <NUM> returns to it collapsed state (<FIG>).

In an embodiment of the invention shown in <FIG>, the press pole <NUM> of device <NUM> is activated externally by a magnetic power source <NUM>. A control on the stroke of the press pole <NUM> can be achieved by regulating the magnetic field intensity. The press pole <NUM> is locked by integral snaps on the bottom cylindrical segment <NUM>. Removal of the press pole <NUM> is achieved by reversing the magnetic field of the magnetic power source <NUM>.

<FIG> are perspective and close-up views, respectively, of an optional mechanically-activated press pole <NUM> of the device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention shown, the press pole <NUM> of device <NUM> is constructed as a linear gear rack and is moved open/closed by rotation of a gearwheel <NUM>. The gearwheel may be rotated using a worm gear <NUM>. The worm gear <NUM> by nature serves also as a locker of the gearwheel <NUM>. A string <NUM> is connected and wrapped around the worm gear <NUM>, pulling of the string <NUM> causes rotation of the worm gear <NUM> thus opening/closing of the press pole <NUM> (depending on which end of the string <NUM> is pulled). In some embodiments, another string (protruding through the vaginal orifice) but in a loop fashion (as opposed to the single string is designed to close the device <NUM> for removal.

<FIG> are perspective views, collapsed and open, respectively, of a biased, <NUM>-piece, cylindrical fecal incontinence device <NUM> (largely based on device <NUM>, with some variances), according to an exemplary embodiment of the invention. In an embodiment, arms <NUM>, <NUM> that connect the bottom (posterior) cylindrical segment <NUM> to the central tube <NUM> and slider <NUM> are longer and shorter (respectively) than the arms <NUM> that connect the other cylindrical segments <NUM>. Thus, during the expansion of device <NUM>, the movement of the bottom (posterior) cylindrical segment <NUM> away from the central axis is of gradually increasing angle (<FIG>) with respect to the longitudinal axis of the device, thereby directly applying pressure on the rectum. The cylindrical segments <NUM>, <NUM> may have an outer soft layer to cushion the vaginal walls.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of a hinged arm fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> is constructed of an outer cylindrical shell <NUM> and a plurality of hinged arms. There are two groups of arms: front support arms <NUM> and rear arms <NUM>, <NUM>. The front support arms <NUM> serve to anchor and/or support the device <NUM> in the vagina. The device <NUM> may have <NUM>, <NUM>, <NUM> or more front support arms <NUM>. At least one of the rear arms <NUM> is configured to apply pressure on the rectum, while the other rear arms <NUM> are configured to support the device <NUM> in the vagina. The device <NUM> may have <NUM>, <NUM>, <NUM> or more rear arms <NUM>, <NUM>.

<FIG> is a top, cross-sectional view of the device <NUM> in its expanded state. The device <NUM> has a central activation shaft <NUM> with tapered surfaces <NUM>. Each of the hinged arms (both rear support arms <NUM> and front arms <NUM>) has a free edge in contact with one of the tapered surfaces <NUM>. When the shaft <NUM> is moved proximally it forces the hinged arms to rotate around their hinges and stretch their free edges outwards. The tapered surfaces <NUM> may have a different angle for the rear supporting arms <NUM> than the angle for the front arms <NUM>, resulting in a different range of motion for the arms.

In an embodiment of the invention, the tapered surface <NUM> which is in contact with the rear arm <NUM> that is aimed to press the rectum has a different angle with regards to the tapered surfaces <NUM> contacting the other rear arms <NUM>, to enable larger range of motion for this arm <NUM>.

<FIG> is a side cross section view of the device <NUM> in its expanded state. In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion of the device <NUM> into a vagina and for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>). The applicator <NUM> includes a holder <NUM> and a pusher <NUM> (<FIG>). The holder <NUM> and pusher <NUM> are configured to allow axial movement of the pusher <NUM> relative to the holder <NUM>, where the pusher <NUM> moves axially within the holder <NUM>. The holder <NUM> has two sets of snaps <NUM> (shown in <FIG>) situated on grooves <NUM> in the front end of the device <NUM>, these snaps <NUM> prevent the device <NUM> from moving distally during insertion. The pusher <NUM> is in contact with the activation shaft <NUM>. Pushing the pusher <NUM> distally causes movement of the activation shaft <NUM> distally thus opening the rear and front support arms (<NUM> and <NUM>) outwards.

On the activation shaft <NUM> there are two locking snaps <NUM> that snap into slots <NUM> on the device <NUM> and preventing the activation shaft <NUM> from moving in the distal direction thus keeping the support arms (<NUM>, <NUM>) opened outwards.

In an embodiment of the invention there is a plurality of slots <NUM> that allow locking of the activation shaft <NUM> in several positions, thus creating multiple expansions options of the rear and front support arms (<NUM> and <NUM>).

The applicator snaps <NUM> are bent inwards and released from the grooves <NUM> by rotation of the applicator <NUM> (around the device's <NUM> longitudinal axis) allowing for applicator <NUM> removal. Once the applicator <NUM> is removed the distal end of the removal string <NUM> is left hanging out of the vagina. To remove the device <NUM> from the vagina, in an embodiment of the invention, the removal string <NUM> connected to the locking snaps <NUM> is pulled, thus bending them inwards, thereby releasing the locking snaps from the slots <NUM>. Releasing of the locking snaps <NUM> allows the device <NUM> to transform from the expanded state <NUM> back to the collapsed state <NUM> for easier removal which is achieved by a sustained proximal tension on the removal string <NUM>.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of a curved fin fecal incontinence device <NUM>, according to an exemplary embodiment of the invention.

<FIG> is a perspective illustration of the device <NUM> within a vagina <NUM>, in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, a main body of the device <NUM> is positioned on the sagittal plane of the patient's vagina, traversing the space between the rectum and the urethra, while applying pressure on the rectum <NUM> and not obstructing the urethra <NUM>. The bottom of the device <NUM> is configured with a rectum pressing element <NUM>, shaped like a curved fin, which also prevents the device <NUM> from rotating. On the top of the device <NUM> there is a urethra supporting fin <NUM> configured to further anchor the device <NUM>, for example by situating in natural crevices in the vaginal anatomy, and/or is configured to prevent direct pressure on the urethra <NUM>, for example by being curved.

In an embodiment of the invention, the device <NUM> is generally configured to occupy the sagittal plane of a vagina such that the rectum pressing element <NUM> abuts the rectum from inside the vagina, while the urethra supporting fin <NUM> is located adjacent to the urethra from inside the vagina. While the device <NUM> is generally shown in a circular shape when expanded in <FIG>, <FIG>, it should be understood that the main body of the device could be just about any shape which is capable of positioning the rectum pressing element <NUM> and the urethra supporting fin <NUM> suitably for rendering fecal incontinence treatment. As examples, the main body of the device <NUM> could be ovoid, prismatic, quadrilateral, multi-sided, and the like, when expanded/deployed in the vagina. Similar rationale applies to other devices described herein, for example, as shown and described with respect to <FIG>, <FIG>, and <FIG>.

Like with some or all of the other devices described herein, in some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and removal. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion.

<FIG> are perspective views of the curved fin fecal incontinence device <NUM> expanded and separated from an applicator <NUM>, respectively, according to an exemplary embodiment of the invention. In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion of the device <NUM> into a vagina and/or for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>). In an embodiment of the invention, the applicator <NUM> comprises a holder <NUM> and a pusher <NUM>. The holder <NUM> and pusher <NUM> are configured to allow axial movement of the pusher <NUM> relative to the holder <NUM>, where the pusher <NUM> moves axially within the holder <NUM>. Pushing the pusher <NUM> causes the proximal end of the device <NUM> to move towards the distal end of the device <NUM>, thereby shortening its overall length and causing an outward expansion of the rectum pressing element <NUM> and the fins <NUM>.

In an embodiment of the invention, when the applicator <NUM> is removed a removal string's <NUM> proximal end extends outside the vagina (similar to a conventional menstrual tampon).

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of an expanding bi-polar fecal incontinence device <NUM> with an applicator <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> comprises two telescopic elements: an upper pole <NUM> and a lower pole <NUM>, shown in more detail in <FIG>. In some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and/or removal. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion.

<FIG> is a perspective view of the expanding bi-polar fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> is positioned in a sagittal plane (i.e. antero-posterior position). where the device extend between the urethra and bladder in front and the rectum at the back) and configured for applying pressure on the rectum and not obstructing the urethra. For example, on the bottom of the lower pole <NUM> there is a rectum pressing element <NUM> that also prevents the device <NUM> from rotating. On the top of the upper pole <NUM> there are curved fins <NUM> further anchoring the device <NUM> and the curvature avoids direct pressure on the patient's urethra.

In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> through deployment holes <NUM> and used for insertion the device <NUM> into a vagina and/or for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>). The applicator <NUM> is made of two handles <NUM> rotationally connected at a common axis (like scissors). Pressing the applicator handles <NUM> toward each other pushes the upper pole <NUM> away from the lower pole <NUM> thereby increasing the overall height (defined as the axis between the rectum and the urethra) of the device <NUM>.

In an embodiment of the invention there is a locking mechanism <NUM> within the lower pole <NUM>. The locking mechanism <NUM> has snaps <NUM> that snap into slots <NUM> in the upper pole <NUM> and thus prevent the device from transforming back from the expanded state to the collapsed state.

In an embodiment of the invention there is a plurality of slots <NUM> allowing multiple snapping positions for the snaps <NUM>. Thus, the device <NUM> may attain different heights.

<FIG> are cross-sectional views, before and after pulling a removal string <NUM>, respectively, of the expanding bi-polar fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, when the applicator <NUM> is removed, a proximal end of the removal string <NUM> extends outside the vagina (similar to a conventional menstrual tampon). The removal string <NUM> is connected to the locking mechanism <NUM>, bends over a pulley <NUM> and gets to the outside of the lower pole <NUM> through a hole. Pulling of the removal string <NUM> causes the locking mechanism bridge <NUM> to twist and the locking mechanism snaps <NUM> to bend inwards thus releasing the lock between the lower pole <NUM> and the upper pole <NUM> and allowing the device <NUM> to return to its collapsed state <NUM>.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of an expanding dual bi-polar fecal incontinence device <NUM> with an applicator, according to an exemplary embodiment of the invention. Device <NUM> is composed of two or more sets of upper poles <NUM> and lower poles <NUM> (a "set" comprising an upper pole associated with a lower pole, similar to device <NUM> shown in <FIG>) connected by connection bars <NUM>. Each lower pole <NUM> has a locking mechanism <NUM> with a separate removal string <NUM>. All removal strings <NUM> are connected in their proximal ends to allow simultaneous transfer to the closed state <NUM> by pulling the removal strings <NUM>.

<FIG> are cross-sectional views of the device <NUM> and applicator <NUM> showing the expansion mechanism of the applicator, according to an exemplary embodiment of the invention. In an embodiment of the invention, the applicator <NUM> is constructed of two handles <NUM>, two arms <NUM> an axis <NUM> connecting the arms <NUM> and the handles <NUM> and a spring <NUM>. When the handles <NUM> are pressed towards each other, the spring <NUM> is compressed and the arms <NUM> are rotated outwards and expand the device <NUM> (<FIG>). When the press on the handles <NUM> is released, the spring <NUM> pushes the handles <NUM> outwards back to their initial position (<FIG>).

<FIG> shows an expansion method using the applicator <NUM> wherein controlled directional <NUM> maneuvering of the handles <NUM> expands the device <NUM> gradually, according to an exemplary embodiment of the invention.

<FIG> show the locking mechanism between the handles <NUM> and the arms <NUM>. A radial array of teeth <NUM> on the arms <NUM> matches another radial array of counterpart teeth <NUM> on the handles <NUM>. When the handles <NUM> are pressed, their rotation is transferred to the arms <NUM> through contact of the counterpart teeth <NUM> and the arms teeth <NUM>. When the handles <NUM> are released, the counterpart teeth <NUM> are leaping over the arms teeth <NUM> as a result of the slanted back faces of the teeth. Thus the arms <NUM> keep their rotated position when the handles <NUM> are returning to their initial position.

<FIG> is an isometric view of an applicator <NUM> with biased handles for use with the device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the pressing surfaces <NUM> of the handles <NUM> are bent to one side to allow a more convenient user hold of the applicator <NUM>.

In some embodiments of the invention, devices <NUM>, <NUM> are activated by means of a screw rod, whereby turning the screw rod opens or collapses the device <NUM>, <NUM>.

In some embodiments of the invention, the devices <NUM>, <NUM> are activated by a piston.

<FIG>, taken together, are perspective views of a support ring part <NUM> and a rectal pressing part <NUM>, respectively, of a two-part fecal incontinence device <NUM> with each part's applicator <NUM>, <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention the support ring part <NUM> is supplied with a particular applicator <NUM> for the insertion and deployment of the support ring part <NUM>. Once the support ring part <NUM> is deployed in the vagina and its applicator <NUM> is removed, the rectal pressing part <NUM> is inserted using its particular applicator <NUM> and reversibly attached to the support ring part <NUM>.

<FIG> are perspective views of the rectal pressing part <NUM> being placed over the support ring part <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the rectal pressing part <NUM> is placed over the support ring part <NUM> in a way that the rectal pressing part <NUM> covers a central tube <NUM> of the support ring part <NUM>. When assembled and/or expanded and/or deployed, at least the support ring part <NUM> stabilizes the device <NUM> in the patient's vagina and the rectal pressing part <NUM> renders pressure to the rectum for providing fecal incontinence treatment.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of the two-part fecal incontinence device <NUM> with the rectal pressing part applicator <NUM>, according to an exemplary embodiment of the invention. In some embodiments of the invention, both the support ring part <NUM> and the rectal pressing part <NUM> assume their collapsed states during storage, insertion and removal. In some embodiments of the invention, the rectal pressing part <NUM> is inserted and placed over the support ring part <NUM> using its applicator <NUM>. The applicator <NUM> serves also to expand a rectal pressing element <NUM>. By pressing the applicator handles <NUM> towards each other, distal ends of the applicator <NUM> arms are moved away from each other, thus pushing the rectal pressing element <NUM> against the rectum, shown in <FIG>. The rectal pressing element <NUM> has snaps <NUM> that snap into slots <NUM> in the rectal pressing mechanism base <NUM> (<FIG>).

<FIG> is a perspective view of the device <NUM> and <FIG> is a cross-sectional view of the device <NUM>, in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, the rectum pressing element <NUM> is shaped to anchor the device <NUM> in regards to the rectum thus reduces the possibility of rotation while applying pressure on the rectum.

In an embodiment of the invention, there is a plurality of slots <NUM> in the rectal pressing mechanism base <NUM> providing the snaps <NUM> with a plurality of locking positions to lock the rectum pressing element <NUM> at different heights.

In an embodiment of the invention, when the applicator <NUM> is removed, the proximal end of the removal string <NUM> extends outside the vagina (similar to a conventional menstrual tampon). The removal string <NUM> is connected to the snaps <NUM>. Pulling of the removal string <NUM> causes the snaps <NUM> to bend inward thus releasing the locking and allowing the device <NUM> to return to its collapsed state <NUM>.

In some embodiments of the invention, the rectum pressing element <NUM> is activated by means of a screw rod, whereby turning the screw rod opens or collapses the rectum pressing element <NUM>.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of a piston activated fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> is made of a pessary <NUM> and a rectum pressing system over the pessary. The device <NUM> is inserted into the vagina using an applicator which is released and removed when the pessary is deployed (<FIG>).

In an embodiment of the invention, the rectum pressing element <NUM> is activated vertically as part of a piston element. The rectum pressing element <NUM> slides with in a piston chamber <NUM>. A filling tube <NUM> connects to the piston chamber <NUM> at its bottom end. A unidirectional pressure valve <NUM> allows air flow from a pump <NUM> through the filling tube <NUM> into the piston chamber <NUM> and can be released to allow backflow. The rectum pressing element <NUM> is held in its activated position by the pressurized air. When the unidirectional pressure valve <NUM> is released, the pressure within the piston chamber <NUM> is released and the rectum pressing element <NUM> is deactivated and descends to its initial position.

In an embodiment of the invention, the pump <NUM> may also be a reservoir for air or liquid or may be attached to such reservoir.

In an embodiment of the invention, when the device <NUM> is deployed in the vagina a proximal end of a removal string <NUM> extends outside the vagina (similar to a conventional menstrual tampon). The removal string <NUM> is connected to the locking mechanism <NUM>. Pulling of the removal string <NUM> causes the locking mechanism <NUM> to bend inward thus releasing the locking and allowing the pessary <NUM> to return to its collapsed state <NUM>.

In an embodiment of the invention pulling the removal string <NUM> also releases the unidirectional pressure valve <NUM>, thus the rectum pressing element <NUM> is deactivated simultaneously with the collapse of the pessary <NUM>.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of a standing rectal pressing element fecal incontinence device <NUM> with an applicator <NUM>, according to an exemplary embodiment of the invention. In some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and/or removal. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion.

In an embodiment of the invention, the device <NUM> has an expandable pessary <NUM> with a rectum pressing element <NUM>. In an embodiment of the invention, the rectum pressing element <NUM> is activated angularly (in respect to the device <NUM> mid plane). The rectum pressing element <NUM> is shaped to anchor the device <NUM> adjacent to the rectum, reducing the possibility of rotation, while applying pressure on the rectum.

In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> and used for insertion of the device <NUM> into a vagina and/or for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>). In an embodiment of the invention, the applicator <NUM> comprises a holder <NUM> and a pusher <NUM>. The holder <NUM> and pusher <NUM> are configured to allow axial movement of the pusher <NUM> relative to the holder <NUM>, where the pusher <NUM> moves axially within the holder <NUM>. Pushing the pusher <NUM> causes the proximal end of the pessary <NUM> to move towards the distal end of the pessary <NUM>, thereby shortening its overall length and causing an outward expansion.

<FIG> is a perspective view of an open and deployed standing rectal pressing element fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the applicator <NUM> activates the rectum pressing element <NUM> by pushing the sliding locker <NUM>. Pushing the pusher <NUM> in the distal direction causes the sliding locker <NUM> to move axially causing the rectum pressing element <NUM> to elevate. When the rectum pressing element <NUM> is situated, the sliding locker <NUM> prevents it from collapsing by two protruding arms <NUM> that lock into corresponding groves <NUM>.

In some embodiments, the rectum pressing element <NUM> is activated by an inflatable/deflatable balloon.

In an embodiment of the invention the sliding lock <NUM> allows for device rectum pressing element's <NUM> locking at different heights.

In an embodiment of the invention a locking mechanism <NUM> prevents the pessary <NUM> from transforming back from the expanded <NUM> state to the collapsed state <NUM>.

In an embodiment of the invention, when the applicator <NUM> is removed, a proximal end of the removal string <NUM> extends outside the vagina (similar to a conventional menstrual tampon). The removal string <NUM> is connected to the locking mechanism <NUM>. Pulling of the removal string <NUM> causes the locking mechanism <NUM> to bend inward thus releasing it and allowing the pessary <NUM> to return to its collapsed state <NUM>.

In an embodiment of the invention, when the applicator <NUM> is removed a proximal end of the FI removal string <NUM> extends outside the vagina (similar to a conventional menstrual tampon). The FI removal string <NUM> is connected to the sliding lock <NUM>. Pulling of the FI removal string <NUM> causes the sliding lock <NUM> to bend inward thus releasing it and allowing the rectum pressing element <NUM> to return to its collapsed state.

In an embodiment of the invention both the removal string <NUM> and the FI removal string <NUM> are tied to each other at their proximal ends thus allowing simultaneous collapse of the rectum pressing element <NUM> and the pessary <NUM>.

<FIG> are perspective views, collapsed <NUM> and open <NUM>, respectively, of a rotation activated fecal incontinence device <NUM> with an applicator <NUM>, according to an exemplary embodiment of the invention. In some embodiments of the invention, the device <NUM> assumes the collapsed state <NUM> during storage, insertion and/or removal. In some embodiments of the invention, the device <NUM> assumes the expanded state <NUM> after insertion.

<FIG> is a perspective view of an open and deployed fecal incontinence device <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the device <NUM> is positioned on the sagittal plane applying pressure on the rectum and not obstructing the urethra. On the bottom of the device <NUM> there is a rectum pressing element <NUM> configured with a bulge to apply pressure to the rectum through the vaginal wall, which also provides resistance against and/or prevents the device <NUM> from rotating. On the top of the device <NUM> there anchoring element <NUM> further anchoring the device and configured with a saddle to cup the urethra to prevent direct pressure on the urethra.

In an embodiment of the invention, the applicator <NUM> is attached to the device <NUM> through two arms <NUM> protruding from the holder <NUM> and connected to deployment hinges <NUM>. The two arms <NUM> are used for insertion of the device <NUM> into a vagina and/or for transforming the device <NUM> from the collapsed state <NUM> (<FIG>) into the expanded state <NUM> (<FIG>).

In an embodiment of the invention, the applicator <NUM> comprises a holder <NUM> and a pusher <NUM>. The holder <NUM> and pusher <NUM> are configured to allow axial movement of the pusher <NUM> relative to the holder <NUM>, where the pusher <NUM> moves axially within the holder <NUM>. Pushing the pusher <NUM> in the distal direction causes the device's arms <NUM> to rotate opposite to each other, causing an outward expansion of the rectum pressing element <NUM> and anchoring element <NUM>. This outward expansion applies pressure on the rectum and the vaginal wall. The two arms <NUM> prevent the device <NUM> from moving distally when pushed by the pusher <NUM> and create a radial force on the device arms <NUM> that rotates the device arms <NUM>.

In an embodiment of the invention there are side stabilizers <NUM> that further prevent the device <NUM> from rotating in the vagina. Expansion of the device arms <NUM> causes an actuator <NUM> to move distally. When the actuator <NUM> moves distally it pushes outwards the side openers <NUM> that expand the side stabilizers <NUM> outwards. When expanded the side stabilizers <NUM> press against the vaginal walls and prevent device rotation.

<FIG> is a partial cross-sectional view of the fecal incontinence device <NUM> showing a locking mechanism <NUM>, according to an exemplary embodiment of the invention. In an embodiment of the invention, the locking mechanism <NUM> prevents the device <NUM> from transforming back from the expanded state <NUM> to the collapsed state <NUM> due to two locking teeth <NUM> situated on an inner spring, that lock into opposite slots <NUM>.

In an embodiment of the invention the locking mechanism <NUM> allows for device <NUM> locking at different angles.

Once the device <NUM> is in the expanded state <NUM> proximal movement of the holder <NUM> releases the holder's arms <NUM> from the deployment hinges <NUM>. In an embodiment of the invention, when the applicator <NUM> is removed a proximal end of the removal string <NUM> extends outside the vagina (similar to a conventional menstrual tampon). The removal string <NUM> is connected to the locking teeth <NUM>. Pulling of the removal string <NUM> causes the locking teeth <NUM> to move inward thus releasing them from the slots <NUM> and allowing the device <NUM> to return to its collapsed state <NUM>.

Further, described ranges are intended to include numbers outside any range described within statistical error and/or inherent measurement equipment limitations.

Claim 1:
A fecal incontinence device (<NUM>, <NUM>) for insertion into a vagina, characterized by:
a plurality of shell segments, which together form an enclosed cylinder with rounded ends in a collapsed state of the device, wherein a lower shell (<NUM>) or bottom segment (<NUM>) of the plurality of shell segments is disposed in the device facing a posterior wall of the vagina when the device is inserted into the vagina;
a pressure generating structure attached to and abutting the posterior-facing cylindrical shell
a state-changing mechanism configured to reversibly transition the device from the collapsed state to an expanded state wherein in the expanded state the plurality of shell segments are separated from each other by the state-changing mechanism; and,
an applicator (<NUM>, <NUM>), removable from the device, inserted into the enclosed cylinder and configured to activate the state-changing mechanism to transition the device from the collapsed state to the expanded state.