Abstract:
An anal irrigation kit provides an improved approach for emptying a bowel by instilling irrigation liquid and stimulating the rectal wall simultaneously. The anal irrigation kit includes an irrigation liquid reservoir, a hand pump, and a soft flow manifold, which can be folded for insertion into a rectum.

Description:
[0001]    The present disclosure relates to bowel irrigation devices, more particularly to a transanal irrigation kit for instilling irrigation fluid into the rectal cavity while also simultaneously stimulating the reflex defecatory response. 
         [0002]    Anal irrigation kits and methods to stimulate the rectal reflex reaction are well known for use by individuals afflicted with neurogenic bowel dysfunction. Neurogenic bowel dysfunction is a disruption of the normal function of the bowel commonly associated with persons suffering from spinal cord injuries, amyotrophic lateral sclerosis, spina bifida, multiple sclerosis, and diabetes mellitus. 
         [0003]    In the most common form of this dysfunction, the bowel will respond reflexively to certain stimuli, but the person cannot empty the bowel with cognitive volition. One method for emptying the bowel for these patients is the general approach referred to as bowel irrigation. In this approach a fairly large amount of liquid is instilled into the bowel, filling the lower bowel. Traditionally this is done by a gravity feed of the liquid, which is a relatively slow liquid instillation. This results in the emptying of the bowel. It is, however, not known to what extent the reflex bowel reaction is involved in bowel emptying as a result of the irrigation. It is thought that this irrigation technique works by mobilizing the bowel contents in the liquid. 
         [0004]    This technique typically requires more than 500 mL and up to 2000 mL of liquid and usually takes a considerable amount of time, up to 30 minutes. The fluid path into the rectum is typically provided by a flow manifold having a cone-shaped end, which flares toward the distal direction, such that the narrow end of the cone is inserted into the rectum. The reverse flared end keeps the user from inserting the rigid tubing end too far into the rectum. The cone-shaped end of the flow manifold is typically filly rigid to facilitate insertion, and so its use presents at least some risk of anal and rectal trauma. 
         [0005]    Many of these irrigation systems require the user to hold the flow manifold in place during instillation of the liquid. To improve upon the inconvenience of having to hold the manifold m place during the irrigation process, some irrigation systems including a retention cuff or a balloon to retain the flow manifold in the rectum have been developed. However, the retention cuff or balloon can be overinflated, and increase the risk of rectal trauma. Further, there have been reports of the balloons rupturing due to over inflation, resulting in an alarming noise and destruction of the product. Furthermore, the retention cuff or the balloon inflation step takes time, and often adds complexity to the irrigation systems. 
         [0006]    Another disadvantage of current bowel irrigation kits is their size. They are generally large, unwieldy, and take up a lot of storage space. This makes them inconvenient for travel and indiscreet in the home. An important factor in their large size is that the liquid reservoir in these current bowel irrigation kits is designed to hold two liters or more in irrigation liquid. This in turn requires the reservoir to be able to rest on the floor, or to be hung in a location remote from the point of use, which in rum requires a fairly long tubing set to conduct the liquid from the reservoir to the point of use. 
         [0007]    Another general and commonly used approach for emptying the bowel is digital stimulation. This approach involves inserting a finger or a dilstick into the rectum, pressing on the rectal wall with the finger or the dilstick, and rotating the finger or the dilstick in a circular manner to stimulate the bowel reflex. This stimulation of the rectal wall causes a reflex reaction that is a defecatory response of the lower bowel. The reflex reaction includes the initiation of peristaltic waves beginning at the splenic flexure, which is the start of the descending colon, down through the sigmoid, and into the rectum. This response also includes relaxation of the internal anal sphincter, which enables emptying of the lower bowel. 
         [0008]    The details of digital stimulation required for a robust reflex response are known only through the trial and error of experience. It seems that multiple stimulation episodes and rotation of the finger around the rectal wall are both important for a good bowel response. The digital stimulation does not require liquid instillation, thus results in less bowel output to manage, and bowel evacuation can proceed somewhat faster than gravity fed irrigation. However, digital stimulation does require inserting a finger or a dilstick into the rectum, which can present a significant risk of trauma for the anal canal and for the rectum. 
         [0009]    Accordingly, there is a need for an improved transanal irrigation kit that provides a lower risk of trauma and a more efficient bowel emptying process, which can be easily manipulated by the user. 
       BRIEF SUMMARY 
       [0010]    A transanal irrigation kit, which provides both irrigation fluid instillation into the rectum, and safe and reliable stimulation of the rectal wall for initiation of the bowel reflex defecatory response, is provided according to various embodiments of the present disclosure. The transanal irrigation kit provides for an improved bowel emptying approach that has a low risk of trauma by use of a soft flow manifold. The soft flow manifold includes a flare at the proximal end and multiple fluid openings for directing fluid streams toward multiple different areas along the rectal wall. The flow manifold is configured such that the flared-end portion can be folded and inserted past the anal canal and into the rectum. Once in the rectum, the flared-end portion self deploys and serves to maintain the flow manifold in place during instillation of the irrigation fluid, without the need to hold the manifold in place by hand. This hands free system for holding the manifold in place eliminates the need for a retention balloon or a cuff that requires inflation. 
         [0011]    Further, the irrigation system provides rectal wall stimulation with controlled pressure fluid streams. This significantly reduces the risk of trauma when compared to use of a finger or a dilstick. A further advantage is that effective bowel emptying can be achieved with significantly smaller fluid instillation volumes. 
         [0012]    In one aspect, an anal irrigation kit includes an irrigation liquid reservoir, a pump, which is in fluid communication with the irrigation liquid reservoir, and a flow manifold, which is in fluid communication with the pump. The flow manifold includes multiple openings and configured to be folded by a user for insertion into a rectum. The flow manifold is made of a soft, resilient polymeric material, such that the flow manifold is sufficiently stiff to be pushed through an anal canal and self-deployable once in the rectum, but soft enough to be manually foldable for insertion into the rectum. In one embodiment, the flow manifold is made of a silicone rubber. Further, the flow manifold includes a flared-end portion, which includes a flared wall and a cover portion. A flow lumen is defined between the manifold walls and cover portion. A distal end of the flared end portion is closed by the cover portion having a circular profile, the circular profile having a diameter between about 1.5 cm and about 7 cm. 
         [0013]    The multiple openings are arranged on the cover portion, and the anal irrigation kit is configured to direct liquid streams in different directions through the multiple openings at a pressure sufficient to stimulate a rectal wall. The multiple openings are configured such that at least one of the multiple openings directs the liquid stream toward the rectal wall at a pressure sufficient to trigger a reflex reaction. In one embodiment, the multiple openings include a center opening arranged proximate a center of the cover portion and at least three peripheral openings arranged along a periphery of the cover portion, wherein each of the peripheral openings directs a fluid stream toward a different location along a polar coordinate. In some embodiments, the pump is a hand pump, and the anal irrigation kit is configured to control a pressure of a fluid stream output through each of the multiple openings by adjusting a volume of fluid expelled by the hand pump per squeeze and a size of each of the multiple openings and a number of multiple openings. In other embodiments pumping devices other than hand operated pumping devices may be utilized. Some embodiments may have the liquid reservoir entirely integrated with the liquid chamber within the pumping device. 
         [0014]    In another aspect, an anal irrigation kit includes an irrigation liquid reservoir, which has an inlet, a first wall and a second wall. The first wall and the second wall are sealed together along peripheral edges to define a cavity. The anal irrigation kit also includes a hand pump, which includes a rigid outer wall, a top inlet and a bottom outlet. The liquid reservoir and the hand pump are connected by tubing. In one embodiment, the liquid reservoir is sized to hold less than 500 cc of liquid, and the tubing connecting the reservoir to the hand pump is less than 20 cm in length. In some embodiments, the irrigation liquid reservoir includes a hole, a circumference of which is of a distance to accommodate a user&#39;s thumb. 
         [0015]    Further, the anal irrigation kit includes a flow manifold, which has a flow lumen therethrough. The flow manifold has an entry end proximate the hand pump and an exit end, which has a flared-end portion. The flared-end portion has an outer surface area and an inner surface area, and at least two openings. The anal irrigation kit is configured such that a flow of an irrigation fluid is channeled through the flow lumen and the multiple openings at a stimulatory pressure. Further, the flow of the irrigation fluid through the flow manifold urges the outer surface area of the flared cover to engage an inner wall of a rectal cavity. The hand pump and the flow manifold are connected via a series of tubing portions. In one embodiment, at least one of the multiple openings is circumferentially located about a distal end of the flared-end portion. Further, the hand pump has a first one-way valve located proximate the top inlet and a second one-way valve located proximate the bottom outlet. In some embodiments, the irrigation liquid reservoir includes a hole, a circumference of which is of a distance to accommodate a user&#39;s thumb. In another embodiment, the anal irrigation kit includes a temperature indicator arranged on a wall of the irrigation liquid reservoir. 
         [0016]    In yet another aspect, a handheld transanal irrigation kit, which has a proximal end and a distal end, includes an irrigation liquid reservoir, a hand pump, and a resilient flow manifold. The irrigation liquid reservoir includes an inlet, and a first wall and a second wall, which are sealed together along peripheral edges to define a cavity. The hand pump includes a rigid outer wall, a top inlet and a bottom outlet, and has a first one-way valve located proximate the top inlet and a second one-way valve located proximate the bottom outlet. The flow manifold is constructed of a soft, resilient material, and has a flow lumen therethrough. The manifold has an entry end proximate the hand pump and an exit end, which includes a flared cover. The flared cover has an outer surface area and an inner surface area, and includes at least two openings. The transanal irrigation kit is configured such that a flow of an irrigation fluid is channeled through the flow lumen and the openings and exits the openings at a stimulatory pressure. 
         [0017]    In another aspect, a method of emptying a bowel includes the step of providing an anal irrigation kit, which includes an irrigation liquid reservoir, a hand pump, and a soft flow manifold including multiple openings. Further, the method includes the steps of folding the soft flow manifold and inserting the folded soft flow manifold into a rectum, and instilling an irrigation liquid and stimulating a rectal wall simultaneously by operation of the hand pump. The soft flow manifold is formed of a soft resilient material, and configured to self-deploy once the folded soft flow manifold is in the rectum. Further, the soft flow manifold includes a flared-end portion, which is folded to increase a bending stiffness of the flared-end portion for insertion into the rectum, which self-deploys in the rectum without a user intervention to provide for hands-free retention of the flow manifold in the rectum during the step of instilling irrigation liquid. The step of instilling an irrigation liquid and stimulating a rectal wall includes expelling liquid streams through the multiple openings, such that at least some of the liquid streams are directed to different areas of the rectal wall at a stimulatory pressure to trigger a defecatory response. The method empties the bowel by mobilizing bowel contents in the irrigation liquid and simultaneously stimulating a defecatory response by expelling irrigation liquid streams at multiple locations along the rectal wall at a stimulatory pressure. 
         [0018]    Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0019]    The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein: 
           [0020]      FIG. 1  is a perspective view of an embodiment of a transanal irrigation kit including an irrigation fluid reservoir, a hand pump, and a flow manifold according to an embodiment; 
           [0021]      FIG. 2  is a perspective enlarged view of the flow manifold according an embodiment; and 
           [0022]      FIG. 3  is a cross sectional view of the flow manifold of  FIG. 2 . 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    While the present device is susceptible of embodiment in various forms, there is shown in the figures and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification of the device and is not intended to be limited to the specific embodiment illustrated. 
         [0024]    Referring to the figures,  FIG. 1  shows an embodiment of a transanal irrigation kit  10 . The irrigation kit  10  generally includes an irrigation fluid reservoir  20 , a hand pump  23 , a flow manifold  24  including multiple fluid openings  52  ( FIGS. 2 and 3 ), and tubing potions  22 ,  28 . The transanal irrigation kit  10  is configured for handheld use by deploying the soft now manifold  24  within the rectal cavity and activating the flow of liquid into the rectum by squeezing the hand pump  23 . 
         [0025]    The irrigation fluid reservoir  20  includes an inlet  30 , an outlet  32 , and walls  34 , which are sealed together along peripheral edges  36  to define a cavity  38 . The walls  34  are formed of a suitable polymeric material, preferably a thin, flexible polymeric film, which is heat sealable. The reservoir  20  has an opening  21  through the reservoir walls that allows suspension of the reservoir  20 , for example, from a user&#39;s thumb. The reservoir  20  includes the inlet  30 , through which the cavity  38  can be filled with liquid. The inlet  30  includes a liquid tight closure  31 , preferably, a resealable closure. In one embodiment, the closure  31  is provided in a form of an interlocking closure device, such as a plastic zipper. The reservoir  20  can include a temperature indicator to indicate the temperature of the liquid in the reservoir  20 . The reservoir  20  can be provided in different volumes or sizes. Preferably, the reservoir  20  is a small volume reservoir, for example, no more than 500 mL in capacity. 
         [0026]    As shown in  FIG. 1 , the irrigation fluid reservoir  20  is attached to the hand pump  23  via tubing portion  22 . Preferably, the tubing portion is no longer than 20 cm, more preferably no longer than 10 cm, most preferably no longer than 3 cm. The hand pump  23  generally includes a pump body  40 , an inlet  42 , and an outlet  44 . One end of the tubing portion  22  is attached to the irrigation fluid reservoir  20  at the outlet  32 , and the other end of the tubing portion  22  is attached to the hand pump  23  at the inlet  42 , thereby providing a fluid path  27  from the reservoir  20  to the hand pump  23 . An advantageous embodiment would have no tubing portion  22 , but rather the outlet  32  of the fluid reservoir communicates directly with the inlet  42  of the hand pump. Tubing portion  28  is attached at the outlet  44  of the hand pump  23 , providing a fluid path  46  from the pump body  40  to the flow manifold  24 . In one embodiment, tubing  28  and flow manifold  24  are continuously formed as a single piece member. Alternatively, the tubing portion  28  and the flow manifold  24  are provided as two separate members sealingly attached to each other. A preferred embodiment is where the two separate members  28  and  24  are attached in a releasable way, to allow for disposal and replacement of the flow manifold with reuse of the remainder of the kit. 
         [0027]    Further, the irrigation kit  10  includes one way valves  25 ,  26 , e.g. check valves, that allow fluid to exit the pump body  40  through the outlet  44  when the pump body  40  is squeezed and prevents backflow to the reservoir  20 , and to enter through the inlet  42  when the pump body  40  is allowed to relax and prevent draining liquid from the manifold  20 . Upon exiting, the hand pump  23 , the fluid travels through the tubing portion  28  and into a flow lumen  58  of the flow manifold  24 . In other embodiments, the irrigation kit  10  can have other liquid pumping devices alternative to a hand pump to transport the irrigation liquid from the irrigation fluid reservoir  20  and force the liquid out through the multiple openings  52 . Some embodiments may also lack a separate liquid reservoir, instead having the liquid reservoir entirely integrated with the liquid chamber that is within the pumping device. 
         [0028]    The flow manifold  24  is located at the proximate end of the irrigation kit  10 .  FIGS. 2 and 3  show the flow manifold  24  including a flared-end portion  48 , the flow lumen  58  ( FIG. 3 ), and multiple fluid openings  52 . In this embodiment, the flow lumen  58 , which is in fluid communication with the tubing portion  28  has a circular cross-section, a diameter of which increases toward a distal end  49  of the flared-end portion  48 . The distal end  49  of the flared-end portion  48  is closed with a cover portion  50 , and includes the multiple fluid openings  52 . 
         [0029]    The distal end  49 , including the cover portion  50 , has a circular profile or shape, which has a diameter between about 1.5 cm and about 7 cm, preferably between about 5 cm and about 2.5 cm, and more preferably between about 2.5 cm and about 3.5 cm. Further, the flow manifold  24  has a wall  64  having a thickness between about 0.3 mm and about 3.0 mm, preferably between about 0.5 mm and about 2 mm, and more preferably between about 0.7 mm and about 1.5 mm. The flow lumen  58  in the flared-end portion  48  is defined between the wall  64  and the cover portion  50 . Although, the flow manifold  24  distal end  49  has a circular shape, in other embodiments, the flow manifold can have a non-circular shaped distal end, such as a distal end having an oval profile or shape. 
         [0030]    The flow manifold  24  is made of a soft, flexible, or pliable material, such that it can be folded and inserted past the anal canal and into the rectum. Further, the flared-end portion  48  is configured such that once it is in the rectum, the flared-end portion  48  self-deploys due to the resiliency of the material. When the flared-end portion  48  deploys in the rectum, it serves to maintain the flow manifold  24  in place during instillation of the irrigation fluid by operation of the hand pump  23 . Further, as irrigation fluid streams are expelled out of the flow manifold  24  through the multiple openings  52  at a sufficient pressure to stimulate the rectal walls via the hand pump  23 , the negative force of the fluid stream output forces the outer surface area of the deployed flared-end portion  48  to engage an inner wall of the rectal cavity to provide a temporary seal between the anal canal and the rectum, thereby reducing the risk of leakage during instillation of the irrigation fluid. 
         [0031]    Suitable materials for the flow manifold  24  include flexible or pliable polymeric materials, which have sufficient resiliency to provide the self-deploying capability of the flared-end portion  48 , for example, certain polyurethane rubbers or latex rubbers, and preferably, silicone rubbers. A flow manifold  24  made of such soft and rubbery polymeric materials substantially reduces the risk of rectal trauma when compared to rather rigid flow manifolds of conventional irrigation systems and a finger or a dilstick for digital stimulation. Further, when folded, the flow manifold  24  provides sufficient stiffness to be pushed through the anal canal, yet is still soft enough to prevent trauma to the anal canal, and to be manually foldable for insertion into the rectum. As stiffness is typically a function of a thickness, the user can simply double fold the flow manifold, which makes it four times thicker than the wall thickness of the flow manifold. This in turn increases the bending stiffness by about 16 times to provide sufficient stiffness for a user to manually insert the flow manifold  24  past the anal canal. Once the flow manifold  24  deploys in the rectum, the rectal walls only encounter the soft flared-end portion  48  with a single wall thickness, which poses a significantly lower possibility of causing trauma to the rectal walls. In other embodiments, the flow manifold  24  can be folded or gathered in various different was to provide for sufficient functional bending stiffness for insertion into the rectum. 
         [0032]    The distal end  49  of the flow manifold  24 , including the cover portion  50 , includes multiple fluid openings  52 , which allow the irrigation fluid to be forced out of the flow lumen  58  by operation of the hand pump  23 . In this embodiment, the flow manifold  24  includes five openings  52  including one circular central opening  54  and four slit-shaped openings  56  formed along the perimeter of the cover portion  50 , which are arranged evenly spaced from one another. The fluid openings  52  are configured and arranged such that each of the fluid openings  52  directs a fluid stream  60  to a different direction to stimulate different areas of the rectal wall. As shown in  FIG. 3 , the fluid stream  60  exiting the center opening  54  is directed along an x-axis  66 . Further, the slit-shaped peripheral openings  56 , which are defined between the wall  64  of the flared-end portion  48  and the center portion  50 , provide slanted fluid paths along the flared wall  64 . Thus, each of the peripheral openings  56  directs the fluid stream  60  to a different direction around a polar coordinate. 
         [0033]    In some situations, when the flow manifold is inserted and deployed in the rectum, some of the fluid streams  60  may be directed along the rectal axis, which do not provide rectal wall stimulations. The normal angle between the axis of the anal canal and the axis of the rectum is about 90 degrees. So, for example when a two opening design is used, it can be the case that one of the two openings is directed along the rectal axis. This will present a very low resistance to water exit from this opening. As a result, the water exit from the other opening, the one that is directed at the rectal wall, will have a lower water pressure than if both openings were directed at the rectal wall. This effect of reducing the pressure directed at the rectal wall because one opening is directed along the rectal axis will be proportionately less of a reduction, the larger the total number of openings. Also, a design that has at least three openings will ensure that stimulation is provided in at least two separate places, even if one of the three openings is directed along the rectal axis. 
         [0034]    Preferably, the flow manifold  24  is a one-piece member, in which the flared member-end portion  48  and the cover portion  50  are continuously formed as a single-piece. Alternatively, the flow manifold can be formed as a two-piece device including a flared-end member and a cover member, in which the cover member is sealingly arranged in the flared-end member. Further, in some embodiments, the flow manifold  24  can include two, three, or four fluid openings, or more than five openings. Preferably, the flow manifold  24  has at least three fluid openings. Further, the fluid openings  52  can be arranged in various locations in the flow manifold  24 , and can have different shapes. Once the hand pump  23  is actuated, the fluid flows into the flow lumen  58  of the flow manifold  24  and exits through the multiple openings  52   
         [0035]    The irrigation kit  10  can be configured to keep the stream pressure on the tissue at a safe, yet stimulatory level. This is done by adjusting the volume expelled by the hand pump  23  per squeeze, and the size of the openings  52 . 
         [0036]    In use, the reservoir  20  is filled with 350-400 cc of water, preferably at body temperature. The reservoir  20  is suspended h use of the opening  21  from, e.g. the left thumb. The patient sits on a toilet, and rests the left hand on the thigh, which also partially supports the reservoir  20 . The irrigation kit  10  is held also by the left hand, perhaps by just holding the tubing portions  22 .  28 . The flow manifold  24  is then folded and inserted by the user into the rectum. Once the manifold is deployed in the rectum, the right hand will be free to hold and to operate the hand pump  23 . 
         [0037]    The hand pump  23  is designed with the one way valves  25 ,  26 , which when squeezed allow irrigation fluid to pass through the flow lumen  58  and into the flow manifold  24 . When the hand pump  23  is released, the fluid is drawn from the reservoir  20  into the pump body  40 . The valves  25 ,  26  prevent back flow to the reservoir  20  and to the hand pump  23 . The hand pump  23  is actuated, for example three times in quick succession, which will accomplish two things. First, about 160 cc of fluid will be instilled via the flow manifold  24  into the rectum. Second, the walls of the rectum near the rectal floor will be stimulated, in multiple separate places, by the water jets that are directed outward through the small slit-shaped openings  56  and the circular center opening  54  of the flow manifold  24 . Because the openings  54 ,  56  are relatively small, and the pump action is relatively vigorous, a flow stream can be generated at a stimulatory pressure. The flow manifold  24 , having more than two openings  52 , generates fluid streams, which can stimulate multiple areas of the rectal wall, in a fashion that is similar to the traditional digital stimulation routine. 
         [0038]    After the two pump instillation, the manifold  24  can be removed, and the bowel can be allowed to empty. This can then be followed by a repeat instillation, again inserting the manifold  24 , pumping three times, and then allowing the bowel to empty. 
         [0039]    All patents referred to herein, are incorporated herein in their entirety or by reference, whether or not specifically indicated as such within the text of this disclosure. 
         [0040]    In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. 
         [0041]    From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present device. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.