Abstract:
The present invention is a drainable ostomy pouch having a closure system that includes a resealable press and seal material. The material facilitates closing and opening of the ostomy pouch outlet. A space between the comfort panel and the pouch material can accommodate the closure system or at least a portion of the closure system.

Description:
The present application is a national stage application of PCT/US08/61212 filed Apr. 23, 2008 and claims priority to U.S. Provisional Application No. 60/913,723 filed Apr. 24, 2007. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to drainable ostomy pouches for the collection of waste from a temporary or permanent ostomy opening and, more particularly, to the closure system for a drainable ostomy pouch. 
     The invention is applicable to a one-piece ostomy appliance in which the drainable pouch is integral with an attachment pad or wafer for attaching the drainable pouch to the body of the ostomate and with a two-piece ostomy appliance in which the pad or wafer for securing the drainable pouch to the ostomate is separate from and is releaseably attachable to the drainable pouch. 
     Drainable pouches include an outlet through which the pouch contents may be drained thereby enabling the pouch to be reused. 
     Some drainable pouches have one or more reinforcing members for controlling the cross-sectional shape of the outlet. The reinforcing members may be used to open the drainage outlet. By manually squeezing the opposite edges of the reinforcing members positioned at opposite sides of the outlet, the reinforcing member can be deformed so as to enlarge the opening. The use of these reinforcing members are described, for example, in EP1378218A1; GB2346328; and U.S. Pat. Nos. 3,825,005; 2,875,451; 5,745,926 and 3,724,461. 
     A drainable pouch has a body portion and a tail portion. The tail portion extends from the body portion and is tapered. The tail portion includes a recloseable outlet through which the pouch contents can drain, typically into a toilet. 
     Of great concern in a drainable pouch is the closure or fastening system for the outlet. Such closure systems may include a separate fastener, such as a closure clip which is removeably positioned so as to pinch closed the pouch material in the tail portion of the pouch outlet when the drainable pouch outlet is to be closed and removed when it is to be opened. Another type of fastener is an integral fastener that is carried permanently on the pouch. A typical integral fastener utilizes mechanical engagement such as a hook and loop fastener or fasteners with mushroom tip projections. 
     There are concerns that arise with each of these types of fasteners. For example, a clip fastener is relatively rigid and some people find them uncomfortable to wear. The clip is also an additional, and typically, separate item which the ostomate needs to manipulate and operate when utilizing a drainable pouch. Providing a clip that suitably pinches the film together so as to prevent leakage while not opening unintentionally or cutting the pouch material and causing leakage are all additional concerns of a clip. 
     The hook and loop type fastener is difficult to wipe clean and it typically has a fabric-type base that absorbs liquids and is difficult to dry when wet. 
     The mushroom projection type fasteners make the drainable pouch more difficult to manufacture since the fasteners require proper placement on the pouch of the strips carrying the projections. Also, the proper manner to close a drainable pouch with these projections and the complexity of the design is not readily intuitive. 
     Furthermore, the hook and loop fasteners and projection type fasteners are typically mounted on a firm backing. This combination of the backing and interlocking material yields relatively rigid components. Concerns that arise include the need for manual dexterity, possible discomfort from the relatively rigid panels and/or tearing of the film by the edges of the panels. 
     Accordingly, objectives of the present invention include providing a closure system that is lightweight, easy to manipulate, integral with the tail, leak proof, soft and flexible, easily re-useable and intuitive. 
     SUMMARY OF THE INVENTION 
     The present invention is a drainable ostomy pouch with an integral closure system. This drainable ostomy pouch includes two panels, a front body-side panel and a rear opposing panel. The body-side panel faces the ostomate when the pouch is worn. The two panels are joined along the outer periphery of each panel in a manner so as to form a pouch with an outlet. In the body-side panel is a stomal opening. The stomal opening receives waste from the stoma of the ostomate. The waste passes through the stomal opening into the pouch. The pouch has a body portion and a tapered tail portion extending from the body portion. The outlet of the drainable pouch is in its tail portion. The drainable pouch has its contents drained through this outlet, typically into a toilet. 
     The tail portion of the present invention includes a closure system with a film on at least one of the two panels making up the tail portion. The film is a thin film capable of adhesively sealing against itself, referred to as self-sealing, when portions of the film are pressed together. The sealed film can be peeled apart and readily resealed. It also functions when wet. The preferred thin film is a self-sealing adhesive coated and textured (SSAT) film developed by Procter and Gamble Company that utilizes a pressure sensitive adhesive to help the self-sealing opposing material to grip each other. This SSAT film is also covered with a multitude of bumps and depressions. The surface of this SSAT film adheres and mates in part with itself as a result of the adhesive used and the fitting of many of the hills into complimentary valleys. While it is possible that other films with an appropriate adhesive and surface topography would function well, it has been found that the press and seal technology developed by Procter and Gamble Company and marketed by The Glad Product Company as a recloseable system for food packaging works particularly well. 
     Patents relating to the Procter and Gamble technology include U.S. Pat. Nos. 5,662,758; 5,871,607; 5,965,235; 6,193,918; 6,421,052; and 6,489,022. 
     The SSAT film has a position proximate to the outlet. The SSAT film on the tail portion is foldable or rollable upon itself so as to close the outlet when the SSAT film is pressed and sealed to itself. The sealed SSAT film can be reopened to permit opening of the outlet. Accordingly, the drainable pouch outlet can be closed so the pouch can receive waste through the stomal opening and collect it in the pouch. The closure system can be opened, the pouch drained and the outlet reclosed. In this manner, accordingly, the drainable pouch can be reused. 
     The SSAT film is preferably on both panels of the tail portion. The SSAT film preferably covers both portions of the tail portion entirely, however, strips of SSAT film on the panels covering less than all of the tail portion may also be used. According to the present invention, strips of the closure material are preferably joined to the opposing sides of the outlet of the drainable pouch. Preferably, the width and length of the strips approximate that of the tail, although the strips can be smaller in length and/or width and still function as a closure system. It is possible to have the SSAT film on one panel of the tail portion and for the closure system to be functional, however, it is preferred to have the SSAT film on both panels. 
     The strips are laminated onto the tail panels. This is typically done with adhesive or by welding, with welding being the preferred manner of attachment. The material welds very well and provides a nice, relatively flat surface. 
     Optionally, SSAT features can be created on the surface of a commonly used pouch film, besides the possibility of a stand-alone SSAT film. For example, the ostomy film (i.e., EVA/EVA/PVdC/EVA/EVA) can be coated with self-sealing adhesives in a textured form. Other processes that can create SSAT feature on a film surface include printing and embossing. 
     The preferred SSAT film material has the adhesive coated textured surface on one side only and it is the side that faces outward from both of the panels of the tail. 
     While the prior art discusses this film technology, there is no suggestion or teaching in the prior art of laminating strips of this SSAT material or one with similar characteristics, to the opposing film panels on the tail of a drainable pouch so as to allow repeatable opening and closing of the outlet. 
     The drainable pouch may have a comfort layer covering at least part of the body-side panel or there may be two comfort panels covering both the body-side and rear opposing panel. Comfort panels are well known in drainable pouches. 
     In the drainable pouch of the present invention, the comfort layer is sealed to the body-side panel and/or the rear opposing panel so as to leave an access opening between the comfort layer(s) and the panel it is covering. The access opening is preferably perpendicular to the longitudinal axis of the tail portion and proximate to where the tail portion extends from the body portion of the drainable pouch. The access opening accommodates part of the tail portion when it is folded or rolled which occurs when the outlet is closed. 
     The pouch may include one or more comfort panels covering the body of the pouch. The base of the comfort panel just above the tail of the drainage pouch may be left open to provide access to the space between the pouch film and the comfort panel. The access opening&#39;s width is preferably at least the width of the tail portion of the pouch. 
     After the tail portion is folded or rolled up it may be inserted through the access opening and tucked into the space between the comfort panel and pouch material. The size of the access opening being of a width to accommodate and retain the rolled up tail. Alternatively, the SSAT film may extend from the tail portion onto the body of the pouch beneath the comfort panel. The comfort panel can be lifted to permit access to the space or pocket by the rolled up tail portion. 
     When the rolled up tail portion is retained between the comfort panel and pouch material it is protected from unintentional unrolling. Also, the outer contour of the rolled up portion is softened by the comfort panel cover. 
     When the pouch is to be drained, the rolled up tail portion is removed from the pocket and unfolded. After draining, or at any time, the surface of the press and seal material can be washed relatively easily. Even when wet, the press and seal surface allows suitable closure of the tail when folded or rolled. 
     The drainable pouch may have reinforcing members on the tail portion proximate to the outlet opening, with one reinforcing member on each panel of the tail portion. Reinforcing members are well known in drainable pouches and they help to facilitate opening of the outlet when the opposing ends of the reinforcing members are pushed laterally toward each other. The reinforcing members can be positioned on top of the press and seal film or the press and seal film may be located on the tail portion but not where the reinforcing members are positioned on the tail portion. 
     The ostomate rolls the tail up and since the material on the tail sticks to itself (adheres) and mates with itself (hills and valleys), the SSAT film seals the outlet as it is rolled up. Since the film of the pouch panels and the SSAT film on the tail portion are each thin and soft when they are rolled up, the resulting roll is relatively soft and thin. The drainable pouch may include the reinforcing members as part of the roll that can act as a guide or template for the folds or rolls. 
     The tail can be folded or rolled up until it reaches a designated level, such as the end of the tail. 
     The SSAT film avoids the need for interlocking components and the process needed for attaching the loop components. The press and seal material can be provided in rolls printed onto the pouch film to facilitate its processing into a drainage pouch having a tail with press and seal material laminated onto it. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  is a schematic plan view of the body-side of a drainable pouch. 
         FIG. 2  is a schematic side view of the drainable pouch of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to  FIGS. 1 and 2 , wherein a drainable pouch according to the present invention is generally designated by the numeral  10 . This pouch  10  has a body-side pouch panel  12  and an opposite side panel  14 . Each of these panels is composed of film material typically utilized for ostomy pouches, such as multiple ply film that includes layers of ethylene vinyl acetate copolymer (EVA) and polyvinylidene chloride (PVDC). 
     The body-side pouch panel  12  has a stomal opening  16  and is shown with mechanical coupling structure  18  surrounding the stomal opening  16 . The coupling may, alternatively, be one used in an adhesive coupling system. The coupling  18  is capable of being secured to a mating coupling on the body-side wafer. It is alternatively possible for the pouch to have an adhesive wafer instead of the mechanical coupling  18  and attach directly to the wearer&#39;s skin. Commonly, a hydrocolloid adhesive is used for this purpose. 
     The drainable ostomy pouch  10  includes a body portion  20  and a tail portion  22 . The tail portion  22  is shown with a reinforcing member  26  at end  28  of the tail portion  22  on the body-side pouch panel  12  and on the opposite side panel  14 . 
     The tail portion  22  has on its outer surface a thin film  30 . This thin film is capable of self-sealing when pressed against itself. It is also capable of being peeled apart or unbonded and resealed when pressed together again. It can be wetted and dried without losing desirable adhesive properties. It can be referred to as a press and seal film with a specific type being the preferred film. The preferred thin film  30  is textured and coated with an adhesive. The texture includes hills and valleys this encourages the sealing of the film to itself. The preferred type of film was developed by Procter and Gamble Company and is sold commonly by The Glad Product Company to seal food containers. The Procter and Gamble film is described and discussed in U.S. Pat. Nos. 5,662,758; 5,871,607; 5,965,235; 6,193,918; 6,421,052; and 6,489,022 incorporated herein by reference. This preferred film has been referred to occasionally herein as SSAT film. 
     The thin film  30  is mounted on the outer surface of both the body-side pouch panel  12  and the opposite side panel  14 . It covers the entire surface of the tail portion  22  except for where the reinforcing members  26  are secured. 
     The reinforcing members may be used as a template or guide when the tail portion  22  is folded or rolled up. 
     The body portion  20  of the pouch  10  has a comfort panel  40  covering the outer surface of the body-side pouch panel and the opposing rear side panel. The comfort panels  40  are welded along their periphery  42  to the panels  12 ,  14 . The comfort panel  40  on the body-side pouch panel  12  lies against the skin of the wearer and is composed of material that is more comfortable to the ostomate than the pouch panel film. Comfort panels  40  may include perforations to allow air circulation and be composed of material so as to reduce potential stickiness to the ostomate due to perspiration. 
     The comfort panels  40  have a base  46  that is not welded or secured to the body-side pouch film  30 . Accordingly, there is access to the pockets formed between the comfort panels  40  and the body portion  20 . The pockets exist because the comfort panels  40  are welded to the pouch film  30  along the periphery  42  but not along the base  42 . 
     It is also possible to utilize the thin film  30  on the tail portion  22  as a closure system by having the material only on one panel of the tail portion  22  and/or utilizing strips of the thin film  30  that do not cover the entire dimensions of the tail portion  22 .