Abstract:
A device and method to avert anal fecal leakage is disclosed that possess at least two means for the prevention of anal leakage or hemostatic application. The device is inserted internally and is used inside of the rectal cavity for absorption along with a sealing member placed externally against the anus which is designed as a secondary means for the prevention of leakage. An embodiment of the device includes a third sealing means to prevent leakage into the anal canal. The device is constructed to be flexible with a minimum of intrusiveness for the user during use. The device is constructed for one person insertion and removal unless patient or user is incapacitated. Due to its design, the device is capable for use over a wide range of human and certain animal applications.

Description:
FIELD OF THE INVENTION 
     The present invention is generally related to the medical field relating to problems that patients who through a variety of reason, suffer from anal fecal leakage. This invention and method for its use is aimed at averting embarrassing situations, isolation of the patient from social events, and reducing the chance of infection and skin damage caused by leakage due to the patient&#39;s inability to cause the anal canal to respond to their need to hold fecal matter inside of their body, evacuating at a time and place of their desire. 
     BACKGROUND OF THE RELATED ART 
     This invention is designed to help patient who suffer from rectal incontinence. People who suffer from rectal incontinence have an inability to control the muscles that control the evacuation of feces via the anal canal. The aim of any product in this classification of medical devices, especially the device disclosed herein, is to reduce or eliminate the amount of fluid or secretions created by the bowel or stool in those who cannot physically control their bodily functions themselves. The fecal matter and associated fluids can also be created by conditions in which are abnormal such as: Crohns disease, ulcertive colitis, and diarrhea sometimes caused by  Giardia  found in untreated water. The anus is almost incapable of holding fine fluid even for a normal person who does not suffer from Rectal incontinence. Incontinence can also be caused by spinal cord injury, Parkinson&#39;s, multiple sclerosis, traumatic brain injury, complications post-surgery, childbirth especially as a result of episiotomy, treatment of the pelvic area with chemotherapies and/or radiation in cancer patients, infections and other causes. Incontinence can also be caused by cognitive/mental disabilities such as severe mental retardation, and severe autism. Due to the nature of the design of this device, and its method for use, this device is also applicable in animals in certain cases as well as in humans. 
     This invention also has its uses during the embalming and postmortem procedures where leakage is a common occurrence with the buildup of gases and fluids in the body which will eventually escape through the natural orifices as the pressure builds. 
     In a healthy subject, one&#39;s fecal continence is controlled by the voluntary constriction of the external and internal anal sphincters which is a circular band of muscle surrounded by a two flattened planes of muscular tissue and the associated constriction of the interior anal sphincter via its set of muscular tissues surround the anal canal. These muscles are always in a state of tonic contraction but yet have no antagonist muscles to oppose the sphincter muscles that act in opposition to the specific movement generated by the sphincter muscles. The muscles can be further constricted by voluntary movement of the subject causing a further occlusion of the anus, the last area of sealing controlled by the external and internal anal sphincters to prevent accidental discharge. 
     The anus is the last part of the intestinal tract. It is the final orifice through which stool passes out of the body. The lower half of the anal canal has sensitive nerve endings. There are blood vessels under the lining, and in its mid portion there are numerous tiny, anal glands. There are visceral nerves inside of the anal canal, which are sensory motor nerves, which feel only pressure. This gives the sensation of fullness and therefore one defecates once a certain pressure is reached. Somatic nerves, one of the nerves of parietal sensation or voluntary motion, are located on the exterior of the anal canal and anus and can feel pressure as well as pain. Due to the density of nerves in this region, it is especially important not to have a device that increases pain and discomfort. 
     The prior art is replete with devices that are used to control anal leakage and can be broken down into three basic categories; 1) devices that are designed to catch the fecal matter as there is no control of the process, 2) devices that attempt to simulate the action of the sphincter muscles and 3) devices meant to stem the tide of the leakage by placing devices into the rectal cavity. 
     Devices in category one include absorbent undergarments, such as adult diapers or waterproof pants or shorts with liners that can absorb liquid matter. These are mostly designed for uniform solid matter. Some of these garments come with reservoirs to hold the solid matter, but this, only increases the bulkiness and decrease the comfort and ease of use when these reservoirs are attached. These garments are already very uncomfortable and bulky to begin with. Physical movement, let alone exercise, and inability to discretely carry multiple diapers, is greatly limited as these garments are not designed for movements of the legs and pelvis, or they are so restrictive that they prevent normal activities, such as walking, running, swimming and intimacy. In addition, the traditional diaper holds fecal material as stated above, therefor placing the patient at risk for skin breakdown, foul odor and pain. Thinner absorbent pads can be used, such as panty liners, but are not appropriate for anal incontinence as the pads are hard to locate retro-anally into undergarments as the garments will shift between standing and sitting to laying and/or walking positions of the users, thereby creating a false sense that the pads will be in the proper location to absorb. Some pads or patches are adhesively adhered to the user. U.S. Pat. No. 8,353,884 issued to Hansen et al on Jan. 15, 2013 and U.S. Pat. No. 7,195,619 issued to Manasek on Mar. 27, 2007 typify the types of absorbent pads or patches that are available. Both are to be placed onto the garments but by their shape and design, they are capable of being located into a close proximity of the anus and are designed to catch the leakage as it is directed into the pad where absorbent material. The &#39;884 patent provides for a two part device where the absorbent pad is unattached to the flanged part which has the advantages of sealing more closely to the anus and addresses the issues regarding the movement of the pad during exercise and simple movements but is confined to those “low-level incontinence” as those without any control of their bowels will have a much heavier flow at times thereby inundating the pads beyond their capacity. 
     Another example of this style of pads are designed to prevent the flow from exiting by closely fitting into the perineum region by fitting within the intergluteal or natal cleft, being held in place through the use of adhesives (U.S. Pat. No. 5,695,484 issued to Cox on Dec. 9, 1997) or by contouring an absorbent pad into a shape that coincides with the shape of the individual&#39;s intergluteal region. Both of these patents approach the problem of leakage uniquely but still have problems similar to the aforementioned prior art. The pads are difficult to place into the correct region, adhesives are difficult to adhere to often hairy skin areas, perspiration and movement by the user can dislodge the pad easily and will cause embarrassing and unsanitary leakage. 
     Prior art discloses devices that try to eliminate the leakage from either trying to trick the body into closing their sphincter muscles or have a mechanical means to accomplish the same result. U.S. Pat. No. 7,360,544 issued to Levien on Apr. 22, 2008 details the insertion of a truncated cone and a straight tube with an angled concavity, which allegedly exploits the voluntary inhabitation action and/or simple closure of the anal slit to decrease facial incontinence or soiling whereby the contraction of the external sphincter muscles to hold the tube will cause a relaxation of the rectum thereby increasing the reservoir capacity of the rectum. This patent assumes that one has the control in the muscles but for some reason, one fails to utilize the control, but does not address those situations where one is without any muscle control of the anus or either of the sphincters. U.S. Pat. No. 5,593,443 issued to Cater et al on Jan. 14, 1997 details a surgical procedure where the action of the damaged sphincter muscle is replaced with an inflatable tube which simulates the sphincter closing off the exit of the rectum by crushing the walls of the lower rectum into the walls of the anal canal with a liquid filled strap from only side of the rectum. Patent Application 2007/0073099 with inventors Forsell published on Mar. 29, 2007, discloses another mechanical device which forcibly seals the anus, but uses a more natural constriction which is circular in nature more closely aligned with the actual functions of the body. The application also discloses alternate adoptions of the device in relation to the rectum and the anal canal. These drastic surgical methods where devices are implanted within the patient&#39;s body are invasive and can cause a host of issues from infections and tearing of the sensitive tissues of the rectum and anus, causing even more damage to the anus, along with repeated mechanical crushing of the tissues to simulate the actions of the sphincter. These surgical techniques and solutions are not intended for everyone and only a small percentage benefit for a period of time from which then, the patient must seek alternative aids. Furthermore, these techniques require anywhere from 4 to 6 months to show some type of relief in selected patients. 
     The third basic categories of device that control anal leakage are devices that are fitted into the rectal cavity and anal canal. A study reported in the European Journal of Pediatrics Surgery in June of 2000 entitled “A new polyurethane anal plug in the treatment of incontinence after anal atresia repair” detailed the efficacy of plastic plugs inserted into the rectal cavity. The study found that the anal plug was the only non-surgical treatment for fecal incontinence available to those patients who want to carry on a complete social life. U.S. Pat. No. 8,444,546 issued to Shalon et al on May 21, 2013 discloses two styles of anal plugs used to prevent incontinence. One style has an applicator inserting a “Y” shaped device which flattens out and seals against the walls of the anal canal. This problem with this style of device is that there is no means to control the position of the plug within the rectal area, let alone maintaining the position in the anal canal.. The British Journal of Nursing in November of 2004 discussed studies perform on a different style of anal plug called the Peristeen Anal Plug, developed originally as the Conveen Anal Plug, which is similar in design to the first iteration of the Shalon device. The journal discussed the positive results, but further clinical experience of others have found that this style of plug has no restriction on the migration of the plug deeper into the recesses of the rectum and further into bowel. There are no means to hold this device in the proper location, and as the user already has weakened or non-existent control of the sphincter muscles already, there is nothing to prevent the device from moving inward as the person moves and especially in the sitting position. In addition, the PU Conveen plug is not practical in the for of application. The user must use his/her fingers to properly insert the plug past the anal canal. This approach is unsanitary and discouraging for patients. 
     The second iteration of the Shalon patent discloses a plug that has a disk that has a diameter slightly greater than the anal canal, it is forced past the anus and both sphincter muscles, with either a two prong introducer or digitally placed, both of which have a much smaller diameter in relation to the diameter of the anal canal as shown in  FIGS. 6B and 8C  of Shalon. The other end of the plug has biasing cap which rests on the exterior of the anus. This biasing cap is to hold the plug in place, preventing the transiting of the plug further into the rectal cavity. The problem of maintaining location has been solved with a very draconian device in a very sensitive area. A person would have a stiff plastic unyielding stem or rod which is connected to a softer disc that have been forced past narrower canals in order to seal a larger canal in the sensitive anal canal. And since the stem connecting the two disks is not adjustable, the individual person is subjected to a norm to fit their particular body, subjecting the user to possible leakage past the lower seal should the connecting be too long for their particular body or the stem not thick enough to seal the anal canal itself. As the European Journal study did find that the plugs, even though made of a PVA or polyurethane material had painful inserts, due to the methods used to deploy these plugs, a feeling of uncomfortable pressure inside of the anal canal and painful plug removal due to the migration of the device inwardly and oversized plug as in the case of the PVA plug. Another study published in Cochrane Incontinence Group Specialized Register in 2012 found that anal plugs work if they can be tolerated and found that even though they are helpful in preventing incontinence, they can be difficult to tolerate due to the stiff and oversized material used. The group found that the rectal cavity must be trained over a few applications and with tolerable materials. The disposal of this device is also questionable as it would not be able to be flushed down the toilet forcing the user to deal with a bowel discharge while removing this device and making sure it does not go down the toilet, as well as having to find an appropriate disposal means. 
     It is an object of this invention to create a device that will prevent the anal leakage associated with incontinence. The device must be designed taking into account that every application is different in size and volume. 
     It is another object of this invention to create a device that will prevent anal leakage associated with incontinence that enables the person to carry on an active lifestyle without the worry of dislodgement or an embarrassing failure of the device, and furthermore, the device must provide comfort and flexible to prevent discomfort to the user. 
     It is further object of this invention to create a device that is comfortable in both the insertion, use and removal of said device from the very sensitive anal canal and rectal cavity, said device being developed with the knowledge that the insertion of the device will most likely be done by the user of the device. If nurse or caregiver is to apply device to patient, device allows for sanitary and non-digital intrusion for administration. This invention should not contain any sharp edges, or stiff connecting rods that cause discomfort, or places the user at risk for internal injury. 
     It is further object of this invention to allow the user to carry multiple units in a discrete fashion. The device is compact and can be carried in pant pocket or purse offering discretion and peace of mind knowing it&#39;s at their disposal. 
     Another object of this invention is to insure that the insertion means is never larger than the anus with minimal stretching of the anal canal during insertion. 
     It is a further object of this invention to create a device the is disposable and that can be removed and flushed down a toilet, reducing handling and disposal problems, since removal is likely to be associated with a bowel discharge. Good sanitary practice reduces the spread of microorganisms. 
     It is a further object of this invention to create a device that has application in all age groups and into fields beyond just human medicine, where animals can benefit from this device as the device should be easy to use, without painful insertion and prevent leakage in light of normal behavior. 
     It is a further object of this invention to have a device that has more than one sealing means to prevent anal leakage should the primary means not provide 100% protection. 
     It is a further object of this invention to have a device that has more than one functional means other than preventing anal leakage; it should also have a hemostatic benefit. On occasion post hemorrhoidectomy, some bleeding may occur internally in the proximal anal opening of internal anal canal region. Pressure placed on the internal region of bleeding area can reduce and cease the bleeding. 
     SUMMARY OF THE INVENTION 
     According to this invention in relation to the prior art discussed, this device for preventing anal leakage in those people who suffer from rectal incontinence is disclosed. This device is flexible and is non-invasive. There are no sharp corners, ridges or disks that are designed to hold the device in the proper location. The device has a proven leakage inhibitor or blocking capability which is deployed into the rectal cavity using a minimally intrusive deployment shield which is inserted into through the anal canal with an integrated stopping shoulder to allow the user the tactical feel of when to stop inserting and to deploy the device safely. The user uses a familiar motion of running the plunger to the maximum extent of its throw, as one would use a syringe. After the leakage inhibitor is deployed by using a plunger as acting as a deployment means, the user withdraws the shield and plunger in one motion exposing the external flapper and stopper which is adjacent to the intergluteal area as possible. This flapper provides a secondary means to prevent anal leakage. An embodiment of this invention includes a secondary internal flapper seal which is deployed along with the leakage inhibitor inside of the rectum. Due to the design of the plunger length, only the leak inhibitor and second internal flapper, if used, will be deployed and the sealing flapper will remain inside of the deployment shield. Withdrawal of the deployment shield and plunger allows for the external sealing flapper to be deployed and cinched against the anus. A small barrel-shaped stopper is cinched behind the sealing flapper to insure a good permanent seal. The flapper and leak inhibitor are connected via a flexible string or member, composed of cotton or synthetic materials such as rayon, said string continuing further past the stopper allowing the user to remove the device. The deployment shield and plunger are made of a recyclable plastic and the leak inhibitor and flapper are made of materials very similar in composition as female tampons. 
    
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
       In  FIG. 1 , shows the basic components of the device shown separated for clarification, from a left side front oblique view. 
       In  FIG. 2 , the deployment shield is shown from a frontal elevation. 
       In  FIG. 3 , the deployment shield is shown from a left side elevation where the plunger has been inserted to its maximum extent. 
       In  FIG. 4 , the deployment shield is shown in a rear elevation. 
       In  FIG. 5 , the deployment shield is shown from a lower rearward elevation where the plunger has been inserted to its maximum extent. 
       In  FIG. 6 , the plunger is shown in a side elevation. 
       In  FIG. 7 , the plunger is shown in a frontal elevation. 
       In  FIG. 8 , the plunger is shown in a rearward elevation. 
       In  FIG. 9 , the plunger is shown in a rearward left side lower oblique elevation. 
       In  FIG. 10 , the anti-reversing barrel stopper is shown in a frontal oblique view. 
       In  FIG. 11 , the barrel stopper is shown in a side elevation. 
       In  FIG. 12 , the barrel stopper is shown in a cross-sectional view from the cross-sectional line in  FIG. 11 . 
       In  FIG. 13 , the device is shown prior to its assembly in a cross-sectional view as the plunger is cross-sectioned through the external ribs. 
       In  FIG. 14 , the device is shown in its assembled condition in a cross-sectional view. 
       In  FIG. 15 , the deployment shield is inserted into the rectal cavity and the leakage inhibitor has been deployed from the device and the plunger has been withdrawn. 
       In  FIG. 16 , the device is deployed completely with the external sealing flapper being secured in the proper location and the flapper is held in position by the barrel stopper. 
       In  FIG. 17 , an embodiment of this invention is shown where a secondary flapper is engaged next to the leakage inhibitor providing a secondary layer of protection from leakage. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1  shows the deployment shield and plunger in an exploded view. Shield  100  is consists of two principle regions; 1) deployment region  106  and 2) finger engagement area  101  which are separated by anus abutment  105 . Abutment  105  has an anterior side  107  which has a slight reverse rake angle to accommodate a more comfortable fit into the intergluteal area and flush against the anus where the rearward side of stop  108  is generally perpendicular to the finger engagement area  101  to accommodate the flat distal side of the users fingers encompassing shield  100  and plunger  200  as the device is ready for insertion as seen in  FIG. 14 . It is critical that abutment  105  is located along shield  100  in a proper distance from the deployment ring  116  so that the device leakage inhibition means  400  (as shown in  FIG. 16 ) is deployed into the anal cavity in the proper area, which is immediately superior to the interior anal sphincter and its set of muscular tissues in the anal canal. Deployment ring zone  116  is located on the distal end of shield  100  and is made up of multiple independent flanges  103 , each being separated by flange gap  104  centered about deployment orifice  102 . Flanges  103  emanate from distal end  112  of bore  116  and are radiused inwardly. Flanges  103  are designed to be sufficiently flexible to enable them to flex outwardly during deployment. This invention is made from a polyethylene or polypropylene material but should be noted that many style of plastic would be appropriate for use. It should be noted the all of the exposed edges of the flanges  103  are rounded without any sharp leading edges and the end of said flanges are radius inwardly to present a blunt end  117  of ring  116  which could decreases the possibility of damage to or piercing of, the tissues of the anal canal and rectal cavity. Rear finger gripping flange  110  is the most proximal place on shield  100  and upper surface  115  serves as the finger rest for the proximal side of the user&#39;s fingers. Flange  110  is generally elliptical in design which corresponds to the mid-digital gripping area of the anterior portion of the hand. The user&#39;s fingers are placed semi-circumferentially about grasping area  101  in a pronated orientation when the device is being used. The rearward surface  114  of flange  110  serves as a tactical stop for the user when the plunger is being inserted through the inner bore  116  of shield  100 . 
     Plunger  200  has a hollow bore with an outer surface  203  and an inner surface  208 , with a plunger travel stop  205  located proximally along outer surface  203  and a beveled channel  202  distally located terminating in a stepped ring  201 . Plunger  200  has located thereupon it&#39;s outer surface  203 , which allows space for flapper  401  to be securely positioned upon distal end of stepped ring  201 , more than 4 ribs  204  whose purpose is to decrease the frictional surface area between the outer surface  203  of plunger  200  and the inner bore  116  of shield  100  as they are moved along the same axis. Plunger  200  is designed to be slidably related to shield  100 , whereby the inner bore  116  of shield  100  accepts the outer surface  203  of plunger  200  where ribs  204  have a clearance fit known as a sliding fit, which is desirable for the plunger to rotate or slide freely within the inner bore of the shield. Stepped ring  201  has a hollow bore distal opening  209  located at the extreme distal end of plunger  200  and connects to the outer surface via a beveled channel  202 . As seen in  FIG. 13 , ribs  204  has a tampered leading edge  207  which tampers into the outer surface  203 . The purpose of ring  201  is to hold the sealing flapper  401  in place and to deploy the leak inhibitor means  400 . The larger the flapper  401 , there will be a greater need to have a location whereby the flapper is able to stored and thus a second stepped surface might be required. Flapper  401  is generally rectangular in shape in order to fit into the intergluteal area and flush against the anus. The width or minor side of the rectangular shape of flapper  401  is greater than the diameter of the user&#39;s anus. As with the shield  100 , plunger  200  is made from a polyethylene or polypropylene material but should be noted that many style of plastic would be appropriate for use. 
     Barrel stopper  300  has an outer surface  302  which thereupon it&#39;s common axis are multiple protuberances  303 , whose purpose is to facilitate a better grip for the user, though a smooth bore can be used. Inner bore  302  contains multiple gripping means  304 . One embodiment has multiple beveled gripping teeth  305  with interiorally beveled triangular sides  306  and  308  with a central vertex  309  terminating in vertex point  307 . This designed to allow for travel along connecting member  402  in a singular direction with minimal resistance, and will grip into said member  402  when the direction of travel is reversed. Barrel stopper  300  can be made of a softer material, such as a silicone or polyvinyl chloride. 
       FIGS. 13 and 14  detail the shield and plunger in preparation for use.  FIG. 13  is a cross-sectional view whereby connecting member  402 , whose composition can be cotton or synthetic fibers, is shown where leakage inhibitor  400  is located at the distal end of said member  402 , securely attached thereto, and member  402  is positioned with inhibitor  400  along inner bore  116  of shield  100 . Plunger  200  has sealing flapper  401  placed over step  201  with member  402  being threaded through the middle of flapper  401  and stopper  300  prior to entering the inner surface  208  of plunger  200  through bore opening  209 . Stopper  300  is threaded through by member  402  and is located within the bore opening  209 . Threaded knot  403  serves as a release preventer, whereby barrel  300  cannot transit any further down member  402  and prevents disassembly of the product during assembly, packaging or use. It should be noted that the length of plunger is limited by the inner bore of the shield as well as being of such length as to be shorter than the inner bore of shield  100 . This shortness allows for the deployment of the leakage inhibitor through flanges  103  but is not long enough to deploy flapper  401  in the same deployment. The plunger is designed to be too short to deploy the flapper into the anal canal as travel stop  205  will prevent any further travel of the plunger into the shield.  FIG. 14  shows the device assembled as ready for packaging. Since this product is not required to be sterile, there are no step sterilization steps after assembly. The material composition of the leakage inhibitor means  400  is similar in composition to a female tampon, having an internal material using cotton, rayon, or a blend of both materials. Rayon is a synthetic product made from cellulose, generally made from wood pulp, which is bio-degradable along with cotton. The interior material is surrounded by an absorbent cover often made of polyester/polyethylene non-woven material. 
       FIG. 15  shows the shield of the device after insertion into the anal canal  1  past the anus  10  and the upper  6  and lower sphincter  6  muscles. As per procedure, the plunger has been completely engaged into the shield causing the deployment of the leaking inhibitor  400  into the ampulla recti  3  inside of rectum  4 . The shield anus abutment  105  has prevented further insertion is it rests upon opening of anus  10  preventing deployment within colon  7 .  FIG. 15  shows that the plunger  200  has been removed to illustrate the contents therein and flapper  401  and stopper  300  are located along the inner bore  116 . However in practice, both shield  100  and plunger  200  will be removed simultaneously in one motion. The user has inserted the shield and plunger assembly through the anus and into the rectal canal after preferably using an anal or petroleum based lubricant upon the deployment ring  116 . User has inserted the shield up to stop  105  and has positioned the middle finger and thumb of their dominant hand, in a pinching fashion on grasping area  101  with the user&#39;s index finger of the same hand articulated about plunger stop  205 . Using a co-planar pinching motion, the user brings their index finger next to the opposing finger and thumb moving the plunger the maximum distance where stop  205  meets the exterior surface  116  of shield  100 , thereby deploying the leakage inhibitor  400  without deploying flapper  401 . Inhibitor  400  is now in position immediately distal to the anal canal in the inferior rectum. The user then withdraws the shield  100  and plunger  200  in one motion, thereby exposing the seal flapper  401  as seen in  FIG. 15 .  FIG. 16  shows the device in place with the removal of shield  100  and the flapper  401  securely held in position by stopper  300  against the anus  10 , guarding against any leakage that could possibly get past inhibitor  400  as a second line of defense, and the remaining portion of the connecting member  402  hangs down below the gluteus Maximus  9  allowing for the user to have access to grasp the member  402  for removal. This remaining portion is referred to as the removal distance, and should be of a length as to permit users of various girths and flexibility to be able to grasp and removal the device. As seen in  FIG. 16 , the device is securely located in the inferior rectum blocking the anal canal where the inhibitor will naturally expand and absorb. Flapper  401  provides for the second stage of protection against anal leakage in this device. 
       FIG. 17  discloses an embodiment of the invention as it shows the addition of a circular sealing disc  404 . This will be the second line of defense to prevent leakage prior to sealing flapper  401 . Disc  404  will be deployed with the leakage inhibitor  400  and is placed in between the proximal anal canal  11  and the leakage inhibitor  400  which will be in the proximal rectal cavity. Disc  404  will create a seal about the distal end of anal canal which is naturally smaller in diameter than the proximal end of the rectal cavity. Disc  404  is greater in diameter than inhibitor  400  and provide a larger sealing area against the opening of the anal canal. As seen in  FIG. 17 , the leakage inhibitor and the secondary disc  404  are securely located in the inferior rectum blocking the anal canal where the inhibitor will naturally expand and seal against the narrow opening of the distal end of the anal canal. The disc  404  is the secondary sealing means or second line of defense sealing against the internal proximal anal canal to prevent any leakage that has not been absorbed by leakage inhibitor  400 . Disc  404  is constructed of a material similar in composition to sealing flapper  401 . In this invention, disc  404  and flapper  401  were constructed using cotton or synthetic fibers such as Rayon, but this invention is not limited to those materials as other material can be proven to work as effectively as these materials. This embodiment provides three stages of leakage protection. 
     Removal of the device is accomplished by securely grasping the member  402  and firmly pulling, while bearing down slightly as if defecating, until the inhibitor  400  safely transits the anal canal and the device can fall into the toilet along with the evacuated fecal matter that has been securely held in place. 
     It can be appreciated by those appropriately skilled in the art that changes, modifications or embodiments can be made to this invention without departing from the spirit, principles, theories, ideas or conceptions that have been disclosed in the foregoing. It is herein recognized that the embodiments disclosed by this description are included as part the best mode of practicing this invention, which will be hereafter described in their full breadth in the claims and equivalents thereof.