Abstract:
A closed drainage system for irrigating colostomy bags wherein the bag is irrigated and cleaned while in its operable position associated with the person. More specifically, the invention mounts a manifold within the colostomy bag with an access to a water pressure from outside, the manifold providing a spray dispersion of fluid, or water preferably, at the top of the bag and gravity then drips it down through the bag and out the open bottom, preferably with the residue of the bag being washed out by the water and passing into a toilet where the user flushes the bag to completion of cleaning with all residue from the bag passing into the toilet. A water source from the toilet itself, or other suitable water supply, provides the pressured water to the manifold inside the top of the colostomy bag.

Description:
RELATED PATENT APPLICATIONS 
     The present invention is a continuation application of U.S. patent application Ser. No. 11/328,599, filed Jan. 11, 2006, which is a continuation-in-part application of U.S. patent application Ser. No. 10/874,294 filed Jun. 21, 2004, the disclosures of which are incorporated by reference herein in their entireties. 
    
    
     BACKGROUND OF THE INVENTION 
     A colostomy is a surgical procedure in which the colon or a portion thereof is removed and the digestive tract is attached to an opening created in the abdominal wall, thereby, allowing digested waste to pass through the abdomen. Typically, the waste is then collected by an impervious bag that is secured over the opening. The opening that results from a colonectomy is known as an “ostomy” or a “stoma,” and the impervious bag that collects the digestive waste is known as a colostomy bag. 
     An individual who has had a colostomy must typically remove and empty the colostomy bag several times a day, and must irrigate the ostomy at least every other day to maintain good health and sanitation. An ostomy is irrigated by applying flowing water into the ostomy and then allowing the water to drain. 
     Examples of ostomy irrigating devices in the prior art or cleansing systems are provided by US Patent Application Publication No. US2003/0229324, which features a closed drainage system that eliminates the necessity to stand over a toilet, as it has its own collection system, but it is a difficult system to use and almost requires the person to be lying down as illustrated in  FIG. 1  for any satisfactory use. U.S. Pat. No. 6,408,861 illustrates a urine bag cleaning manifold, which is a very complicated system associated with a shower in a bathtub, and again, is difficult to operate and very elaborate in design. U.S. Pat. No. 5,454,389 teaches an ostomy bag cleaning device that incorporates a mechanism for introducing water into a colostomy bag and then evacuate the waste material into a storage chamber. This device is cumbersome to use and does not provide for a simple cleaning of the colostomy bag without removal from the person. 
     U.S. Pat. Nos. 5,096,503 and 4,194,506 both teach the general concept of insertion rods being inserted from the bottom of the colostomy bag up into the bag itself, and in both of these systems it&#39;s awkward to have to insert a rod up through the bottom of the colostomy bag with whatever drippings and materials that would be coming out, and this is not a satisfactory technique for cleaning the colostomy bag while having the bag still maintained on the person. A similar patent is U.S. Pat. No. 5,738,668, which again inserts a probe up into the bag for cleaning, and again the same problems are inherent. U.S. Pat. No. 6,532,971 teaches a sanitary pouch washer that is designed for simultaneously cleaning the inside and outside of the colostomy bag and is a complicated mechanism and, again, is done with the colostomy bag removed from the person. U.S. Pat. No. 6,224,581 teaches a colostomy bag cleaning appliance having a mounting plate and, again, this is a cleaning method with the bag removed from the person and creates significant complications in achieving the cleaning in a simple and effective manner. 
     SUMMARY OF THE INVENTION 
     The present invention is a closed draining system for irrigating ostomies and cleaning colostomy bags utilizing a manifold physically located near the top of the bag that provides a stream of water in a sprayed fashion into the top of the bag for internally cleaning the bag and simultaneously cleaning the ostomy, and with the amount of water added being controlled by the user, the bag still being in place on the person, and the flow from the bag coming out the bottom with the normal opening type bags available today. 
     Accordingly, it is a principal object of the invention to facilitate cleaning of the colostomy bag and simultaneously irrigating the ostomy by providing a manifold near the top of the colostomy bag that is connected to a source of water under some pressure that can then controllably sprinkle water into the colostomy bag for cleaning and irrigation of the bag and the ostomy, with the flow then directed out the bottom of the normal opening-type colostomy bags. The person still has the colostomy bag attached to their body, and the cleaning takes place preferably in association with drainage into a toilet or other suitable drainage facility. 
     A further object of the invention is to provide that the cleaning of the colostomy bag takes place with the bag still attached to the body of the person, and it can be done quickly and very effectively on a regular basis during the day. 
     It is a further object of the invention to provide the manifold in conjunction with a standard colostomy bag flange, which is a flanged ring with adhesive backing that is typically secured to the abdomen of a person with an ostomy. The flange allows a colostomy bag to be easily attached and detached. The colostomy bag attaches to the flanged ring much like a plastic lid attaches to a plastic or metal can, i.e., the colostomy bag and flange snap together to form an airtight seal. Consequently, an irrigating system that uses the same flanged ring is also easily attached and detached and, further, does not necessitate the removal of the bag from the person for the irrigation. 
     Finally, it is an object of the invention to provide improved elements and arrangements thereof for the purposes described, which is inexpensive, dependable and fully effective in accomplishing its intended purposes. 
     These and other objects of the present invention will become readily apparent upon further review of the following specifications and drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of the colostomy bag utilizing a manifold around the flanged opening on the bag itself, which then attaches to the flanged fitting positioned on the body of the person, and snaps together to form a fluid-tight seal between the bag and the person; 
         FIG. 2  is a perspective illustration showing a stick figure utilizing the invention by irrigating and flushing the colostomy bag by controlling a valve from the water supply to the toilet with the bottom of the colostomy bag open and flow taking place from the manifold through the bag and into the toilet; 
         FIG. 3  is a perspective illustration of the manifold associated with the flanged ring and adhesive backing attached to the person and engaging in the snapped fluid-tight relationship with the fitting on the colostomy bag, but wherein the manifold is associated with the fitting carried by the person and functions to clean and irrigate by water pressure coming in sprayed fashion from this manifold; and 
         FIG. 4  illustrates a colostomy bag with the manifold positioned around the top of the formed snap connection for the bag itself and water inlet being provided to the manifold around the top of the bag connection opening; 
         FIG. 5  is a cross-sectional illustration of a modified colostomy bag, having a manifold heat-seal formed into the material itself and at the very top access opening into the bag well above the stoma opening; 
         FIG. 6  is a top-plan view of a colostomy bag showing some hook and loop strips along the bag, to be folded up in half and held in that position; 
         FIG. 7  is the bag shown in  FIG. 6  folded-up, reduced in half its length in the position where the beg is held in the folded position by the hook and loop strips; 
         FIG. 8  is a cross-sectional illustration of the bag of  FIG. 5  taken on line  8 - 8  of  FIG. 5 ; and 
         FIG. 9  is a broken-away cross-sectional view of the bag of  FIG. 5  taken on line  9 - 9  of  FIG. 5 . 
     
    
    
     DESCRIPTION OF THE INVENTION 
     Referring now to  FIG. 1  of the drawings, the numeral  10  indicates a colostomy bag, which has an opening  12  that is surrounded by a plastic ring  14  and attached in a fluid-tight fashion to the bag  10  by suitable means, such as adhesively or by other suitable known means. The ring  14  is formed with a flange that is designed to mate with a similarly formed ring and flange  14 A on the person mounted colostomy bag attachment patch  16 . The patch  16  is attached by pressure-sensitive adhesive on the back of the patch itself and the respective ring flanges  14  and  14 A when snapped together form a fluid-tight seal between the ostomy  18  and the interior of the colostomy bag  10 . 
     The irrigating and cleansing technique of the invention is provided by a circular manifold, generally indicated by numeral  20 , which is preferably a soft plastic and encircles the interior of the opening  12  into the colostomy bag  10 . A plurality of small holes  22  around the perimeter of the manifold  20  are provided to allow the passage of spray in multiple and random directions of water pressure introduced through an access tube  24  that is connected to a water source not shown via fitting  26 . 
     The colostomy bag  10  in the usual fashion is designed to be opened at the bottom end, generally identified by numeral  30 , and effectively, this is a rolled up sealing procedure utilizing hook and loop tape indicated by the loop material  32  and the hook material  34 . It is well understood that when this is folded up and the hook and loop attachment is in place the bag is sealed at the bottom, but for the purposes of the irrigation and cleansing of the instant invention, the bag is opened and positioned over the toilet so that irrigation cleansing water passing through the manifold  20  and orifices  22  will flow down through the bag and out the bottom opening  30  and into the toilet, as is shown in more detail in  FIG. 2  of the drawings. 
     Referring now to  FIG. 2 , this illustrates a normal toilet indicated generally by numeral  40 , and the individual normally sits backward on the toilet seat to operate the invention. A flexible water hose  42  is connected to the fitting  26  to provide water pressure through the conduit  24  and to the manifold  20  for spray out the orifices  22 . The water source is by a fitting indicated generally by numeral  44  that fits into the normal water supply tubing to the toilet, indicated by numeral  46 , and has the ability to control the amount of flow by a valve, indicated by numeral  48 , associated with the conduit  42 . 
     Thus, with reference to  FIG. 2 , it can be understood that the individual sits backward on the toilet seat, connects the conduit  42  to fitting  26  and then, by adjustively controlling the valve  48 , provides a sufficient amount of water pressure into the manifold to cause a flow to irrigate the ostomy  18  as seen in  FIG. 1 , and to provide a cleansing and irrigating action within the colostomy bag  10 , with the residue dripping out at the bottom into the toilet as shown generally by numeral  50 . 
     Referring now to  FIG. 3  of the drawing, this shows the embodiment where the manifold, identified generally as numeral  20 A, is associated with the RING  14 A of the patch  16  that is attached to the skin of the person over the ostomy opening  18 , and in this instance, includes an access fitting  24 A adaptively connected to the water line  42  so that regulated water pressure provides the spray through orifices  22 A illustrated generally by the numeral  60 . 
     Referring now to  FIG. 4 , this shows a further embodiment of the invention where the manifold, indicated generally by numeral  20   b , as can be seen is positioned above the opening  12  in the colostomy bag  10 . A similar water inlet  24   b  is utilized in this embodiment. 
     Reference should be made to  FIG. 5 , which is a further modification of the manifold  20   b  as shown in  FIG. 4 . More particularly, the manifold in  FIG. 5  is formed by heat-sealing the bag  10  along the line shown generally by numeral  80 , and this extends from the edge of the bag as shown on the left side at  82  and around below the bottom of the top of the bag and over to the right side, indicated by numeral  84 . The sealed line  80  effectively mirrors the shape of the top edge of the bag to form a uniform up-and-down width to the manifold formed by line  80 . The plurality of openings  86  are provided then through the heat-sealed portion  80 , and this then provides for the random and multi-directed flow of water sprayed as it comes into the access opening indicated by arrow  88  going down into the manifold form by heat-sealed line  80 . Access opening into the bag is indicated generally by numeral  90  and, preferably, it includes a one-way valve  92  that prevents back-flow up through the opening  90  in case the bag is squeezed or actuated through the force of fluid back up through the opening  90  in the bag. One other feature which is important in this heat-sealed construction is that there is a divider indicated generally by numeral  94  that is part of the heat-formed portion of the manifold and this acts to direct the water flow entering through opening  90  in equal and opposite directions around to the right and the left sides of the bag as is indicated by the water flow arrows indicated generally by numeral  96 . 
     Thus, it should be understood in the embodiment of  FIG. 5  that the water flows in the direction indicated by arrow  88  through the one-way valve  92  and into the manifold formed by the heat-sealed line  80  and is directed equally right and left by the divider  94  and then flows through the multiple openings  86  formed by the heat-sealed areas indicated generally then the water flow by numeral  96 . The openings  86  provide then for a plurality of openings from the manifold through the heat-sealed portion  80  and facilitate a very significant pattern of water in random directions from the very top of the colostomy bag down over the stoma opening and then as it drains out through the bottom as described with respect to the bag above. Also note the openings  86   a  and  86   b  immediately adjacent the outer edge of the bag that send a water spray down the inside edges of the bag for better cleaning of these surfaces 
     Thus, it is seen in  FIG. 5  and as also shown in the cross-sectional configurations of  FIGS. 8 and 9  that the manifold  20   b  of  FIG. 4  is in fact enhanced and enlarged and modified by the heat-sealed line  80  at the top of the bag in  FIG. 5 , and the random directed openings  86 . It should be understood that the bag  10  is formed from two similarly shaped essentially flat pieces of polymer material that are heat sealed at the periphery in a heat-sealed line  80   a  as seen in  FIGS. 5 and 8 . 
       FIG. 9  illustrates the cross-sectional portion of the bag of  FIG. 5  taken on line  9 - 9  and it is depicted in the mode where there is water pressure within the manifold opening to form effectively an outwardly formed tubular configuration in the manifold itself as it is pressurized by the water entering in the direction of arrow  88  as shown in  FIG. 5 . 
       FIG. 8  is simply showing the multiple openings  86  that are formed by the heat-seal across the manifold-forming heat-seal line  80 , as shown in  FIG. 5 . 
       FIGS. 6 and 7  show hook and loop attachments  100  and  102 , which allow the total bag to be folded into the position from  FIG. 6  as indicated by the arrow  104  to the half-position shown in  FIG. 7 . This is convenient in certain times when the bag is not really full to allow a person to have a smaller bag than the full length bag of  FIG. 6 , and it greatly facilitates keeping the bag from interrupting sleeping because of the smaller size. 
     Thus, it should be understood that the bag depicted in  FIGS. 5 ,  8  and  9  is a very simply made bag with the heat-seal line  80  being formed in the bag according to standard heat-seal procedures and simultaneously forming the openings  86  so that there will be a random and plentiful flow, much like a shower, from the openings and the water pressure being applied through the opening  90  into the top of the manifold formed by the heat-sealed line  80 . 
     Thus, it should be fully understood that  FIGS. 5 ,  8  and  9  show the heat-sealed pouch configuration consisting of two chambers separated by a heat-sealed septum, line  80 , containing a number of communication ports  86  connecting the two chambers. This is the essence of the showing of  FIG. 5 , with the upper chamber (or plenum) being the smaller of the two, with the means of being connected to an external water supply, and the lower chamber being the larger of the two, with the means of opening the bottom to accommodate the removal of its contents. The communication ports  86  connecting the two chambers are strategically positioned to distribute the water that enters through the smaller, or upper, chamber in a manner that thoroughly cleanses the complete interior of the larger (or lower) chamber. It will also thoroughly cleanse around the stoma opening at the same time. 
     The heat seal of the tube to the film material and the outer perimeter and septum geometry are done using RF (Radio Frequency or dielectric) sealing methods. Impulse sealing can be used for the outer perimeter and septum seals, but RF is the method of choice when tubing is being sealed to a film material. The actual sealing takes place by locating the layers of the film material onto a fixture that is called a receiver. The sealing die, which is machined to the exact dimensions of the seal design, is then lowered onto the top face of the film layers under a required pressure, and the RF is actuated, which generates an instant heat at the interface of the upper and lower film materials. This creates the optimum seal available for the type of application, and is how line  80  is formed. 
     The ports  86  are created by machining slots through the heat sealing die in the defined locations. Because the heat sealing process requires two flat surfaces pushing together under a pressure to create the seal, these slots create interruptions in the flat surface, and therefore are not pushing the material together at those locations. Because the material does not have intimate contact at those points, it will not seal together, therefore creating the holes through the septum. 
     The present design has 18 passages and they are 0.090 wide when the material is lying in the flat position. When the water distribution chamber (or plenum) is filled with the pressurized water, the passages then change their geometry to a rounder hole with a diameter that approaches 0.06 diameter. Their actual shape is probably more oblong, but the effective opening is that of a round hole with that cross section. The ideal size would vary between 0.05 to 0.12 inches diameter. The total number of openings  86  could also vary from about 14 to 24. 
     It is further important to stress that the system is pressurized by water pressure coming from a water line that normally provides water to the toilet itself or something similar thereto. Another important point included in the modifications shown in  FIG. 5  is that there is an external port  110  from the plenum to vent accumulated gas to a charcoal filter  112 , thus allowing gas relief without odor. 
     It should be understood that while  FIG. 2  illustrates the water pressure as coming from a water line  46  that normally provides water to the toilet itself, the invention contemplates that any suitable source of water and some pressure will meet the objects of the invention. For example, a bottle of water with the ability to squeeze the bottle will provide pressure. Similarly, a small battery-operated pump with a water source would provide the pressure. It is believed that the invention will best be set up for a person to utilize in their own bathroom in their own home. However, there may be instances when they are traveling or not provided with a facility set up with the ability to hook the water hose to the adaptor  26  and feed the conduit  24  into the manifold, and thus any pressure source will be suitable. 
     It is also to be understood that the spray holes  22  in the manifold in  FIG. 1  are of no particular consequence except to provide a suitable, fairly fine, spray that will tend to both wash and clean and irrigate the residue inside the colostomy bag itself so as to facilitate cleaning in the shortest possible time. It has been found that this system can provide cleaning in just a few minutes and can be done several times a day very conveniently by virtue of the very simple application of water pressure through the manifold to clean the colostomy bag itself. 
     It is to be understood that the ease and the functioning of this invention is the fact that the manifold is positioned high in the colostomy bag, thus, with a large spray pattern clears the bag from the top down, and it has been found it is desirable to have the manifold positioned no lower than the opening  12  in the colostomy bag for the stoma for attachment to the stoma flange  14 A. This then provides for good gravity flow of the water being used in the irrigating and cleansing system, allowing it to flow down through the bag, picking up all residue and out the bottom opening  30 . It also should be understood that any colostomy bag that opens at the bottom end will work with the invention. 
     It is to be understood that the scope of the invention is not to be limited by the descriptions and explanations set forth above, but that the invention encompasses any and all embodiments within the scope of the following claims.