Patent Description:
The present disclosure relates generally to body cavity irrigation devices, methods and systems and, in particular, to systems including a transanal irrigation device that includes an extended handle that is usable by patients possessing a wide range of dexterity levels and a liquid pressurizing device.

Transanal irrigation (TAI) is a process used by individuals who have bowel management issues, such as incontinence, constipation or other neurogenic bowel dysfunction (NBD). Alternatively, TAI may be used for regular bowel evacuations by individuals who are incapacitated due to illness or other medical conditions or injuries (such as spinal cord injury) and thus lack the mobility to access a toilet. During TAI, water or other lavage liquid is introduced into the rectum and colon through a device positioned through the anus so that feces are flushed and evacuated. This creates pseudo-continence for the patient/user. Furthermore, individuals that are bedridden may develop fecal impaction. Such bowel obstructions may be removed via TAI.

Systems for performing TAI currently on the market allow the user to introduce water into the bowel through a rectal catheter while the user sits on a toilet or a commode/shower chair or lays in a bed. The user introduces an amount of water or other liquid into the bowel (typically <NUM>-<NUM>) in order to flush out stool located in the bowel passage. The user typically introduces the water, waits for a period of time and then allows gravity to flush the water and stool out of the body. <CIT> discloses a device for administering liquid into the bowel of a person. The device comprises a rigid conduit, a manually actuatable pump, and a reservoir holding the liquid. The conduit is of a general J-shape having an elongated straight proximal section and a curved distal section terminating in a tip having an aperture therein. The elongated proximal section is sufficiently long that when the person is seated on a toilet with the proximal section located between the person's legs the tip is located at the person's anus, so that he/she can readily insert the tip into the anus by manually manipulating the proximal section of the conduit. The pump is coupled to the proximal section of the conduit and is arranged to be squeezed by the person to pump the liquid form the reservoir through the conduit and out the aperture into the person's bowel. <CIT> discloses a conduit clamping device that can be used to remove or supply air or fluid. The device comprises a movable arm or disk that is connected to a manipulation arm or a knob, a conduit in form of a tube, that is laid flat against an abutment or protrusion, and a guide structure that constrains the movable arm or disk between the guide structure and the tube, designed such that the movement of the arm or disk will control the compression of the tube. The conduit clamping device may be used in a control unit that can be part of an irrigation system. The irrigation system may also include a reservoir and a probe.

For TAI users, independence, dexterity, and ease of use are important needs that must be addressed by a TAI system or method.

The invention is defined by the features of independent claim <NUM>. There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described below. These aspects may be employed alone or in combination with other aspects of the disclosure, and the description of these aspects together is not intended to preclude the use of these aspects separately or in different combinations.

In one aspect, a system for performing transanal irrigation includes a liquid pressurizing device configured to contain and pressurize a supply of flushing liquid. The system also includes a transanal irrigation device having an elongated neck having a proximal end and a flushing liquid channel passing therethrough. The flushing liquid channel is in fluid communication with the liquid pressurizing device. An insert is positioned on the proximal end of the neck and is adapted to be inserted into a body cavity of a user. The insert also has a flushing liquid opening that is in fluid communication with the flushing liquid channel of the neck. A control housing is connected to the neck. A pump is positioned within the control housing and configured so that when the pump is activated, pressurized flushing liquid from the liquid pressurizing device flows through the flushing liquid channel and exits through the flushing liquid opening of the insert.

An embodiment of a transanal irrigation (TAI) system is indicated in general at <NUM> in <FIG>. The system includes a transanal irrigation device, indicated in general at <NUM>, a liquid pressurizing device, indicated in general at <NUM>, and a tubing or tube line <NUM> connecting the two components <NUM> and <NUM>.

While the invention is described below in terms of use as a transanal irrigation device and system, it is to be understood that the invention could be used to irrigate other body cavities of a user including, but not limited to, stomas and body cavities accessible by stomas.

As illustrated in <FIG> and <FIG>, the TAI device <NUM> takes the form of a wand and includes a control housing <NUM>. As illustrated in <FIG>, the control housing includes a chamber that houses a pump <NUM>, inlet and outlet valves 28a and 28b, control circuitry <NUM> and a battery <NUM>. Inlet and outlet valves 28a and 28b may be solenoid operated valves or alternative types of automatic valves. Alternatively, manual valves may be used. A power on/off button or switch <NUM> and an activate/deactivate pump button or switch <NUM> are mounted in the control housing <NUM> as well. The top and bottom surfaces of the control housing <NUM> include recesses 40a and 40b so that the control housing may function as a handle.

An intermediate portion <NUM> is attached to the proximal end of the control housing <NUM>, while an elongated neck portion <NUM> is attached to the proximal end of the intermediate portion <NUM>. As illustrated in <FIG>, a flushing liquid channel <NUM> extends through each of the control housing <NUM>, intermediate portion <NUM> and neck portion <NUM>. The control housing <NUM>, intermediate portion <NUM> and neck portion <NUM> may be integrally molded as a single piece, such as from plastic, or they may be formed as separate components that are joined together. In addition, the flushing liquid channel may be integrally molded within the control housing, intermediate portion and neck portion, or it may be separately formed as a tube that is positioned within these components.

As illustrated in <FIG>, the intermediate portion <NUM> includes an ear or tab <NUM> to which is pivotally mounted a support arm <NUM>. The pivot connection permits the support arm <NUM> to be folded between a use position, shown in <FIG>, where the longitudinal axis <NUM> of the support arm <NUM> is generally perpendicular to the longitudinal axis <NUM> of the intermediate portion <NUM> and the control housing <NUM>, and a transport or storage position, where the arm <NUM> is positioned adjacent to the intermediate portion <NUM> and the control housing <NUM> with longitudinal axes <NUM> and <NUM> parallel to one another. This folding action is illustrated by arrow <NUM> of <FIG>.

Support arm <NUM> is pivotally mounted to the intermediate portion <NUM> in a similar fashion and features a longitudinal axis <NUM>. As indicated by arrow <NUM> of <FIG>, the support arm <NUM> also folds between the use position shown in <FIG> to a transport or storage position where the longitudinal axis <NUM> is parallel to longitudinal axis <NUM>.

A squeeze bulb <NUM> is mounted on a fitting <NUM>. As illustrated in <FIG>, tubing line <NUM> is connected to the fitting <NUM>. As shown in <FIG>, fitting <NUM> includes a passage <NUM> that is in fluid communication with flushing liquid channel <NUM>. A pair of check valves, illustrated at 78a and 78b in <FIG>, are positioned between the interior chamber of the squeeze bulb <NUM> and the passage <NUM> of the fitting <NUM>.

With reference to <FIG>, the proximal end of the neck portion <NUM> is provided with an insert mount <NUM> that features a passage <NUM>. Passage <NUM> is in fluid communication with the flushing liquid channel <NUM> (<FIG>) via fitting <NUM>. As illustrated in <FIG>, <FIG> and <FIG>, a disposable insert cone, indicated in general at <NUM>, is removably positioned on the insert mount <NUM>. The insert cone <NUM> includes a combination shield and stop <NUM> and a generally cone-shaped (or frusto-conical) core <NUM>. Core <NUM> may feature alternative shapes such as cylindrical. Core <NUM> includes a tip <NUM> that is provided with a flushing liquid opening <NUM>. Flushing liquid opening <NUM> is in fluid communication with the passage <NUM> of the insert mount <NUM> when the insert cone <NUM> is positioned thereon.

As shown in <FIG>, <FIG> and <FIG>, a flexible body <NUM> surrounds the exterior surface of the sidewall of the core <NUM> and is circumferentially attached to the tip <NUM> so as to surround, but not obstruct, flushing liquid opening <NUM>. The bottom of the flexible body is joined to the combination shield and stop <NUM> so as to be circumferentially spaced from the base of the core <NUM> and define an annular chamber <NUM> (<FIG>). The annular chamber <NUM> is filled with a lubricating gel. The flexible body <NUM>, which may be made of a material such as silicone, rubber or the like, is provided with a number of pores <NUM>.

Alternative heads may be positioned on the insert mount <NUM> in an interchangeable fashion. For example, a flushable pre-check head, which may or may not be cone-shaped, may be used.

As noted previously, with reference to <FIG>, a liquid pressurizing device <NUM> is joined to the TAI device <NUM> via tube line <NUM>. The liquid pressurizing device <NUM> features a body <NUM> which houses a flushing liquid reservoir <NUM>. The reservoir <NUM> contains a supply of flushing liquid, such as water. A handle <NUM> may be actuated by the user, as indicated by arrows <NUM>, to activate a pressurizing feature of the device <NUM>. As a result, the flushing liquid inside of the reservoir <NUM> is pressurized and flows to the TAI device <NUM>. Additional details regarding the liquid pressurizing device <NUM> may be found in International Patent Application No. <CIT> (International Publ. Alternative types of pressurizing devices and/or reservoirs known in the art may be used instead.

In operation, the flushing liquid within the liquid pressurizing device <NUM> is pressurized. The insert cone <NUM> is positioned on the proximal end of the device <NUM>, as illustrated in <FIG>, and the support arms <NUM> and <NUM> are placed in the use positions illustrated in <FIG>. The user then sits on a toilet, grasps the handle (control housing <NUM>) and passes the neck portion <NUM> of the device between his or her legs so that the insert cone <NUM> is positioned below the anus <NUM>, as shown in <FIG>. The user then rests the support arms <NUM> and <NUM> (<FIG>) on the tops of his or her thighs so that a fulcrum is formed, and the TAI device <NUM> may be moved by the user as a lever or in a see-saw fashion.

The user next moves the handle (control housing <NUM>) downwards so that the proximal end of the neck portion <NUM>, and thus the insert cone <NUM>, rises towards the anus <NUM> (<FIG>). As the user continues to move the handle <NUM> downwards, the insert cone <NUM> passes through the anus <NUM> and into the rectum <NUM> (<FIG>). As this occurs, the flexible body <NUM> of the insert cone is compressed by the anus and rectum and gel (<NUM> in <FIG>) is eluted through pores <NUM> of the insert. As a result, the surface of the insert cone <NUM> is lubricated thus easing insertion.

Once the insert cone <NUM> is inserted into the anus and rectum, the user may initiate flow of the flushing liquid through the flushing liquid channel <NUM> (<FIG>) of the TAI device <NUM> by first turning on the device by pressing power on/off button <NUM>. This opens the solenoid operated inlet and outlet valves 28a and 28b. Next, the user presses pump activation/deactivation button <NUM>, which activates the pump <NUM> (<FIG>). As a result, pressurized flushing liquid flows from the liquid pressurizing device <NUM>, through tube line <NUM>, through the flushing liquid channel <NUM> of the TAI device <NUM>, out of opening <NUM> of the insert cone <NUM> and into the patient's rectum. After a period of time, the user again presses the pump activation/deactivation button <NUM> to deactivate the pump and stop the flow of flushing liquid into the rectum. The user then presses the power on/off button to close the inlet and outlet valves 28a and 28b.

After a period of time, the user pulls up on the handle <NUM> so that the insert cone <NUM> is removed from the user's rectum and anus, and the flushing liquid and fecal matter drain by gravity into the toilet.

If the user finds that the pump <NUM> is too powerful and/or is more comfortable using a manual pumping mechanism, the squeeze bulb <NUM> (<FIG> and <FIG>) may be used to deliver the flushing liquid to the user's rectum instead. More specifically, the user presses the power on/off button <NUM> to open the solenoid operated valves 28a and 28b, but does not press the pump activation/deactivation button <NUM>. The user then repetitively squeezes and releases the squeeze bulb <NUM>. Due to the check valves 78a and 78b (<FIG>), flushing liquid from the liquid pressurizing device <NUM> (and tube line <NUM>) is drawn into the interior chamber of the squeeze bulb <NUM> and then expelled in an alternating fashion so that the liquid is pumped through the flushing liquid channel <NUM> of the TAI device <NUM>, out of the opening <NUM> of the insert cone <NUM> and into the patient's rectum. The user then presses the power on/off button to close the inlet and outlet valves 28a and 28b.

Claim 1:
A system for performing transanal irrigation comprising:
a) a transanal irrigation device including:
i) an elongated neck (<NUM>) having a proximal end and a flushing liquid channel (<NUM>) passing therethrough, said flushing liquid channel (<NUM>) adapted to communicate with a supply of flushing liquid;
ii) an insert (<NUM>) positioned on the proximal end of the neck, said insert adapted to be inserted into a body cavity of a user and having a flushing liquid opening (<NUM>) that is in fluid communication with the flushing liquid channel of the neck;
iii) a control housing (<NUM>) connected to the neck;
iv) a pump (<NUM>) positioned within the control housing and configured so that when the pump is activated, a pressurized flushing liquid from the supply of flushing liquid flows through the flushing liquid channel and exits through the flushing liquid opening of the insert;
characterized by:
(b) a liquid pressurizing device (<NUM>) configured to contain and pressurize the supply of flushing liquid.