Patent Publication Number: US-2007100303-A1

Title: Controlled evacuation ostomy appliance

Description:
FIELD OF THE INVENTION  
      The present invention relates to the field of ostomy appliances, and in particular to such appliances which can be used to control stomal discharge, occasionally referred to as controlled evacuation appliances.  
     BACKGROUND TO THE INVENTION  
      The creation of an ostomy (stoma) is the therapy for many sufferers of diseases or injury of the gastrointestinal or urinary tract. An ostomy is the rerouting of the tract through the abdominal wall to outside the patient&#39;s body. Once a stoma has been created, the patient must, frequently for the rest of his or her life, use a device worn on the body for capturing or containing the body waste. This has traditionally been done with a bag or pouch attached to the body with adhesive patches or constricting belts. However, the wearing of such a pouch can be an extremely embarrassing experience for many ostomates. Also a pouch may require significant changes to a person&#39;s public and personal activities.  
      A controlled evacuation appliance offers the potential for an ostomate to return to some form of normalty. The appliance is used to block the stoma mouth, in order to store the liquid and/or solid stool temporarily inside the tract. The appliance is deactivatable and/or removable manually when the ostomate desires to discharge the stool from the stoma. A design feature which distinguishes a controlled evacuation appliance from a conventional ostomy pouch is the presence of a stoma seal, for blocking the stoma mouth. However, there are many practical and challenging difficulties associated with implementing a cost efficient, yet effective, comfortable and unobtrusive stoma seal. It is believed that this may be one of the reasons why controlled evacuation appliances have hitherto not found widespread use.  
      Reference may be made to the controlled evacuation devices described in U.S. Pat. No. 6,723,079 and U.S. Publication No. 2004/0193122. The devices generally comprise a flexible stoma seal contained in a rigid, closed, U-shaped cap-like structure for supporting the seal.  
     SUMMARY OF THE INVENTION  
      Broadly speaking, the present invention relates to a restraining structure for a stoma seal in a controlled evacuation ostomy appliance. The restraining structure serves to (i) restrain the stoma seal with respect to a body attachment device, and/or (ii) transfer a sealing force (or its reaction force) between the body attachment device and the stoma seal.  
      In one form, at least a portion of the restraining structure is flexible (e.g., non-rigid). The flexible portion acts in tension to generate, apply or transfer the sealing force (or its reaction) to the stoma seal.  
      In another form, the restraining structure only partly covers the stoma seal. The structure includes one or more apertures that expose the uncovered parts. The structure may be substantially entirely flexible, or partly flexible, or substantially entirely non-flexible.  
      In another form, the restraining structure has a dome-shape, at least in use. The term “dome” is used herein to mean any shape that has a smoothly curved profile, whether the curve is uniform or varying. The structure may be substantially entirely flexible, or partly flexible, or substantially entirely non-flexible.  
      Although the above features have been defined independently, any two or more of the above features may be used in combination. The present invention explicitly envisages all such possible combinations.  
      Additional or alternative aspects, features and advantages of the invention may be defined, or apparent from, the following description, claims and drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a schematic cross section showing a first example of a controlled evacuation ostomy appliance in use on the body.  
       FIG. 2  is a schematic cross section showing a second example of a controlled evacuation ostomy appliance in isolation.  
       FIG. 3  is a schematic cross section showing a third example of a controlled evacuation ostomy appliance in isolation.  
       FIG. 4  is a schematic rear view showing a fourth example of a controlled evacuation ostomy appliance in isolation.  
       FIG. 5  is a schematic cross section showing a fifth example of a controlled evacuation ostomy appliance in isolation.  
       FIG. 6  is a schematic cross section showing a sixth example of a controlled evacuation ostomy appliance in isolation. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      Referring to  FIG. 1 , a controlled evacuation ostomy appliance  10  is illustrated in accordance with the principles of the present invention. The appliance comprises a stoma seal (depicted schematically at  12 ) for blocking or occluding the mouth of a wearer&#39;s stoma  14 , in order to substantially contain faecal matter internally in the intestinal tract.  
      The stoma seal  12  may at least partly enter the stoma  12 , or the seal may be substantially non-entrant. A non-entrant seal contacts substantially only externally facing stomal tissue. The stoma seal  12  comprises a first face (or portion)  12   a  that faces generally towards the stoma  14 , and a second face (or portion)  12   b  that faces generally away from the stoma  14 .  
      The stoma seal  12  may be inflatable, or non-inflatable. The stoma seal  12  may be compressible or non-compressible. The stoma seal  12  may, by way of example, comprise a membrane, or a plurality of membranes, or a foam. The stoma seal  12  may be gas-impermeable or gas-permeable. The stoma seal  12  is substantially impermeable to liquid and solid fecal matter.  
      The appliance  10  further comprises an attachment device  16  for attachment to the body. The attachment device comprises a wafer or pad of a skin-friendly adhesive. The attachment device  16  is permanently attached to the appliance  10  to form a so-called “one-piece” appliance, or at least a part of the attachment device  16  is releasably attached (or attachable) to the appliance  10  to form a so-called “two-piece” appliance. Alternatively to an adhesive attachment device  16 , the attachment device  16  may comprise a belt-attachment including a belt to be worn by the wearer, an item of clothing incorporating the appliance  10 , or mechanical or magnetic attachment devices that form an attachment to permanent features of the wearer.  
      The appliance  10  further comprises a restrainer (restraining structure)  18  for supporting the stoma seal  12 . The restrainer  18  may itself be supported directly or indirectly by the attachment device  16 , for example at the periphery of the restrainer  18 . At least a portion of the restrainer  18  may be flexible, e.g., substantially non-rigid. The flexible portion may be elastic, or non-elastic (e.g., non extendable). The restrainer  18  functions to support the stoma seal  12  by its second face (portion)  12   b . The restrainer  18  acts at least partly under tension, to transfer a sealing force (or its reaction force) directly or indirectly between the stoma seal  12  and the attachment device  16 . At least the flexible portion of the restrainer  18  acts under tension. The reaction to the sealing force is borne by the attachment device  16  mounting the appliance  10  with respect to the wearer&#39;s body.  
      Depending on the design of the appliance, the flexibility of (at least a portion  18   a  of) the restrainer  18  would enable the appliance  10  to be especially unobtrusive when worn under clothing. The flexibility enables hard edges of a rigid cap-like structure to be avoided, as such hard edges could show through a wearer&#39;s clothing. The flexibility may also reduce the degree of rigidity of the appliance  10  as a whole. Reducing the rigidity makes the appliance  10  less obtrusive, and also allows the appliance to conform more easily to the shape of the wearer&#39;s body. Reducing the rigidity would also enable the appliance to be collapsible to some extent when not in use, and thus reduce the size of the appliance  10  for storage, transportation and packaging.  
      Depending on the design of the appliance, the use of tension in the flexible (portion of the) the restrainer  18  may enable the restrainer to have a low profile while still providing an effective structure for transferring a sealing force (or its reaction) directly or indirectly between the attachment device  16  and the stoma seal  12 .  
      The restrainer  18  is adjustable by the wearer, in order to adjust the sealing force applied by the stoma seal  12  against the stoma  14 . For example, an adjustable tensioner (depicted schematically at  22 ) is included for adjusting the tension in the flexible portion of the restrainer  18 . Alternatively, the sealing force may be predetermined by the relative dimensions of the appliance  10 .  
      The restrainer  18  may be configured to apply a uniform force over the area of the seal  12 , or the restrainer may be configured to apply a non-uniform force. For example, the tension in the flexible portion of the restrainer  18  may vary at different points.  
      The restrainer  18  (or its flexible portion) may have a closed loop configuration, or it may have a non-closed loop configuration.  
      Referring to  FIG. 1 , the restrainer  18  is entirely flexible. For example, the restrainer  18  consists of a flexible sheet, or a web or net, that is attached to the attachment device  16  at the periphery of the restrainer  18 . The restrainer  18  acts as a flexible sling or flexible cup to restrain the stoma seal  12  with respect to the attachment device  16 .  
      Alternatively, referring to  FIGS. 2 and 3 , only a portion  18   a  of the restrainer is flexible while another portion  18   b  of the restrainer is substantially non-flexible (e.g., rigid). In  FIG. 2 , the non-flexible portion  18   b  comprises a peripheral (e.g., cylindrical) wall carried by the attachment device  16 . The flexible portion  18   a  comprises a flexible rear portion supported by the non-flexible portion. The flexible portion  18   a  supports the stoma seal  12 . In  FIG. 3 , the non-flexible portion  18   b  comprises a rear portion that supports the stoma seal  12 . The flexible portion  18   a  comprises a flexible and/or collapsible intermediate portion between the non-flexible portion  18   b  and the attachment device  16 . The flexible intermediate portion provides a degree of shape independence between the attachment portion and the non-flexible rear portion  18   b , such that the relatively rigid rear portion  18   b  would not restrict the conformability of the attachment device  16  to conform to the shape of the wearer&#39;s body.  
      The restrainer  18  may cover the stoma seal  12  substantially entirely, or the restrainer  18  may only partly cover the stoma seal  12 . For example, referring to  FIG. 4 , the restrainer  18  could be frame-like, or cage-like, and comprise one or more apertures  20 . The apertures expose the stoma seal  12 . The restrainer  18  may be substantially entirely flexible, or partly flexible or non-flexible (e.g., rigid). For example, a flexible restrainer  18  may be formed by one or more straps extending over the stoma seal  12 .  
       FIG. 5  illustrates a hybrid embodiment combining the examples of  FIGS. 1 and 4 . The restrainer  18  comprises a restrainer frame  18   c  (similar to  FIG. 4 ) which supports a restrainer sheet  18   a  (similar to  FIG. 1 ). The restrainer sheet  18   a  may be more flexible than the restrainer frame  18   c.    
      In a further modification of  FIG. 4 , exposed portions of the stoma seal  12  may be protected by a flexible cover (not shown) that is positioned between the stoma seal  12  and the restrainer  18 , or outside the restrainer  18 . Such a cover does not provide a restraining function.  
      Referring to  FIG. 6 , the restrainer  18  comprises a dome-like structure. The restrainer  18  is entirely flexible (similar to  FIG. 1 ), or partly flexible or non-flexible (e.g., rigid). The use of a dome-like shape enables the appliance to have a “soft” profile by avoiding sharp corners or edges. Such a profile enables the appliance to be relatively unobtrusive when worn under clothing.  
      The foregoing description is merely illustrative of preferred forms of the invention. Many modifications, improvements and equivalents may be used within the scope and/or spirit of the invention.