Abstract:
Provided is a cap device for home use to temporarily cover the stoma resulting from a urostomy, colostomy or ileostomy procedure. It provides a favorable means of preventing leakage during routine cleaning around the stoma during the ostomy pouch replacement process. The device may include, in any combination, use of a flexible elastomeric material for creating low suction to assist with retention, a shaped lip for comfort and sealing, a disposable liner, or internal absorption material to help avoid spillage and leakage.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims an invention which was disclosed in Provisional Application Number 61120468, filed Dec. 7, 2008, entitled “Stoma Cap Device for Ostomy Maintenance Assistance”. The benefit under 35 USC§119(e) of the United States provisional application is hereby claimed, and the aforementioned application is hereby incorporated herein by reference. 
       REFERENCES CITED 
       [0002]    U.S. Pat. No. 3,958,556
 
U.S. Pat. No. 4,258,704
 
U.S. Pat. No. 4,950,223
 
U.S. Pat. No. 5,045,052
 
U.S. Pat. No. 5,090,424
 
U.S. Pat. No. 5,125,916
 
U.S. Pat. No. 6,569,081
 
U.S. Pat. No. 7,258,661
 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0003]    Not Applicable 
       REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISK APPENDIX 
       [0004]    Not Applicable 
       BACKGROUND OF THE INVENTION 
       [0005]    The subject matter is in the medical field of devices for home care use. It helps prevent leakage of effluent from the stoma during the cleaning and pouch replacement processes associated with an ostomy. An ostomy procedure is necessary to produce an alternate outlet for waste from the body when the normal path is damaged or must be avoided for medical reasons. This new outlet is a portal constructed of the patient&#39;s own body tissue, presenting an opening called a stoma. The stoma typically has a rim approximately one inch in diameter slightly protruding from the abdomen. Being constructed of internal tissue, it is vulnerable to abrasion injury. Normal effluent is collected in a pouch appliance adhesively attached to the skin around the stoma. In some configurations, the pouch may be detachable from a pouch-holder component, called a flange, which is adhesively attached to the skin. The collection pouch may be emptied multiple times by such detachment or through a valved outlet portion of the pouch. 
         [0006]    Periodically, with an interval usually in the 3- to 5-day range, the flange and pouch adhesive interface must be replaced. For appliances with the detachable pouch, such renewal typically involves the following steps:
       Remove the old flange and pouch,   clean an dry the skin around the stoma where the adhesive interface will contact it,   apply a new layer of protective skin barrier and allow it to become tacky,   attach a new adhesive flange to peristoma area, and   attach a new pouch.
 
For one-piece pouch appliances, the procedure is similar except for the separate removal and replacement of the flange.
       
 
         [0012]    During this replacement process, effluent continues to leak from the stoma and must be collected or prevented from interfering with the tasks. Furthermore, if the peristoma area is not dry when applying the adhesive component, the adhesive will not hold securely, and/or the skin may become irritated and erode with time. 
         [0013]    Previous methods to prevent leakage such as those described in U.S. Pat. No. 3,958,556, U.S. Pat. No. 4,258,704, U.S. Pat. No. 4,950,223, U.S. Pat. No. 5,045,052, U.S. Pat. No. 5,090,424, U.S. Pat. No. 5,125,916, U.S. Pat. No. 6,569,081, and U.S. Pat. No. 7,258,661, for instance, involve the less desirable process of inserting something into the stoma. 
         [0014]    Other previous methods known to have been suggested by medical professionals to mitigate consequences of leakage include physical obstruction by hand with non-purpose designed objects lacking sealing surfaces, other forms of plugging with penetrating objects, or frequent mechanical wiping, all options with less effectiveness, comfort, or desirability than the current invention. 
       BRIEF SUMMARY OF THE INVENTION 
       [0015]    The subject item, referred to as the Stoma Cap, is a device suitable for temporarily capping a stoma resulting from urostomy, colostomy and ileostomy procedures, to assist in their maintenance processes for short periods during pouch replacement procedures, described in BACKGROUND OF THE INVENTION, by collecting effluent leakage that would interfere with those procedures. 
         [0016]    The Stoma Cap provides a method of stopping stoma leakage during cleaning procedures without requiring any penetration of the stoma hole, and it can be left in place through the step of applying the adhesively attached flange, ensuring maintained cleanliness. Some embodiments may facilitate hands-free usage. Further, it is easy to work around the device to perform the procedures described in BACKGROUND OF THE INVENTION. Its smooth opening edge is comfortable and makes a good seal without a lot of pressure. In some embodiments, the Stoma Cap can be applied with a small amount of suction to help keep it in place and make an even better seal. It may be used with hand pressure in cases where vacuum seal is not maintained or desired, and it may be augmented with adhesive or sealing lubricant. It can be loosely packed with absorbent material to absorb the collected effluent and keep it from spilling when the Stoma Cap is removed. It can be easily cleaned after each use, and non-disposable embodiments can be easily sterilized before each use. It is inexpensive. 
         [0017]    An example embodiment of the Stoma Cap consists of a flexible elastomeric bulb approximately cylindrical in shape with a closed end and an open end. It has a lip around the open end with a comfortably soft rounded flare to encourage it to seal against the skin with minimal force and to avoid contact abrasion and the sort of penetration discomfort a narrow edged hard material might cause. The flexible material also allows the user to squeeze the upper end before application, to encourage formation of a slight vacuum to assist in retaining the device during short intervals such as during cleaning. When a detachable pouch type appliance is used, the narrow size of the Stoma Cap allows installation of the replacement adhesive flange, referred to in BACKGROUND OF THE INVENTION, over the top of the Stoma Cap because the opening in the pouch holder is sized for the stoma and therefore fits over the Stoma Cap which is approximately the same diameter. 
         [0018]    Additionally, the Stoma Cap may include internal absorption material such as cotton wadding or cotton balls to collect effluent and help avoid spillage upon removal. 
         [0019]    Another embodiment of the Stoma Cap may have multi-segment construction in which each segment is optimized for its function, such as a particularly soft and flexible sealing lip coupled to a firm body for structural support, coupled to a deformable section suitable for squeezing or axial movement useful in creating a vacuum. 
         [0020]    Still another embodiment may utilize multiple chambers communicating through check valves such that additional vacuum may be created after attachment to the patient&#39;s skin, in order to restore vacuum lost to leakage or influx of gas from the stoma. Such chambers may be within the single piece Stoma Cap device or may be separate and connected through tubing. 
         [0021]    Further features of any of the above embodiments may include size adjustment features such as multiple tear-off rings at the open end, each revealing a smaller sealing lip when removed, or a roll-back flexibility which produces a smaller diameter opening as the lip is rolled back due to a substantially conical shape near the open end. Also, the Stoma Cap may be provided in different sizes to fit various stoma diameters. 
         [0022]    Another advantageous feature may be construction such that the Stoma Cap is reversible to facilitate internal cleaning. 
         [0023]    Still another embodiment may be a Stoma Cap that is a single-use, consumable, disposable element of an ostomy service kit, avoiding the need for cleaning, inserting absorbent material and subsequent handling of contaminated absorbent material, and allowing sterile conditions with every use. 
         [0024]    Additionally, adhesive, selected for appropriate removable tackiness and biological inactivity, may be used to assist sealing and retention of the Stoma Cap over the stoma. Such adhesive may be pre-applied to a disposable single-use Stoma Cap device or may be applied prior to use of a multi-use device. 
         [0025]    Additionally, lubricant, such as a bio-inert silicone grease or medical lubricant may be applied to the lip of the Stoma Cap or edge of the stoma region to facilitate superior sealing. 
         [0026]    An additional embodiment utilizes the external-only feature of the Stoma Cap, but does not require flexible vacuum retention; rather it may be of a substantially firmer construction, may be shorter and contain less volume, and may be held in place only by manual pressure or adhesive lip. 
         [0027]    An additional embodiment utilizes a durable non-consumable body along with consumable disposable inserts containing absorbent material and using a formable membrane to line the inside of the durable body, form over the lip, and seal to the user&#39;s body. This saves sterilizing the durable body of the Stoma Cap. 
         [0028]    An additional embodiment incorporates a double wall such that the vacuum for retention is presented only along the annular ring of the lip contact to skin, avoiding applying any vacuum to the stoma itself. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0029]      FIG. 1  is an oblique view of the Stoma Cap, tipped to allow seeing the absorbent material inside. 
           [0030]      FIG. 2  is an isometric section view showing the Stoma Cap in a use position over a stoma, with the section cut away to reveal the stoma and the interior of the Stoma Cap with the absorbent material. 
           [0031]      FIG. 3  is a composite perspective view showing how a two-piece ostomy pouch appliance would be sequentially assembled, using the Stoma Cap to maintain cleanliness through the step of attaching the flange to the skin. 
           [0032]      FIG. 4  depicts a cross section view of a Stoma Cap with various size lip rings which may be removed until a size fitting the particular patient remains. 
           [0033]      FIG. 5  depicts a cross section view showing a Stoma Cap with a lip that can be rolled back to a smaller diameter of a substantially conical portion of the body near the lip, allowing size adjustment by such rollback. 
           [0034]      FIG. 6  depicts a cross section view showing a Stoma Cap with two internal chambers and two check valves, enabling the user to increase the vacuum by additional pumping after the Stoma Cap is in place. 
           [0035]      FIG. 7  shows a variation of the two chamber embodiment, with the pumping chamber being a separate bulb connected to the body of the Stoma Cap with a tube, and communicating to the Stoma Cap through the tube and two check valves, one of which vents to outside air and the other of which prevents escape of vacuum from the Stoma Cap when the tube is removed. 
           [0036]      FIG. 8  shows a Stoma Cap with an inserted replaceable liner containing absorbent material, the liner folded back over the lip of the Stoma Cap and retained by a strengthened edge. 
           [0037]      FIG. 9  shows a Stoma Cap designed with an internal passage communicating the vacuum chamber to an annular contact area of the lip, isolating the vacuum from the stoma. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0038]    Referring now to the device in more detail, in  FIG. 1  there is shown a Stoma Cap device  1 , typically approximately 5 to 7.5 centimeters (2 to 3 inches) long and typically approximately 2.5 centimeters (1 inch) in diameter, although the size may vary to accommodate different types of sizes of ostomies. It may be fabricated of semi-flexible elastomer such that it can be squeezed by finger pressure but naturally spring back to the shape shown. The lip  3  of the open end of the device is smoothly curved to prevent abrasive edges contacting the skin and to encourage sealing against the skin. The internal cavity of the device is shown to contain an amount of absorbent material  2  suitable for absorbing effluent which may leak from the stoma during the use of this device. 
         [0039]    Referring now to the device in more detail, in  FIG. 2  there is shown a Stoma Cap device  1 , which view is sectioned to reveal the interior, in a use position with the lip  3  contacting skin  6  surrounding stoma  5  such that leakage from stoma  5  is discouraged from escaping to the surrounding skin  6  and is encouraged to be absorbed and contained inside Stoma Cap  1  by absorbent material  2 . 
         [0040]    Referring now to the device in more detail, in  FIG. 3  there is shown a Stoma Cap device  1 , which view is sectioned to reveal the interior, in a use position contacting skin  6  surrounding stoma  5  such that leakage from stoma  5  is discouraged from escaping to the surrounding skin  6  during emplacement of flange  7 , which can be slipped over Stoma Cap  1  to adhesively attach to skin  6  without allowing leakage. Subsequently, Stoma Cap  1  can be removed, with spillage discouraged by absorbent material  2  retaining effluent which may have come from stoma  5  during the interval of time that Stoma Cap  1  was in place, and pouch  8  can be attached to flange  7 . 
         [0041]    Referring now to the device in other possible embodiments, in  FIGS. 4 and 5  can be seen two configurations facilitating adjustment of size of the open end of the Stoma Cap  1  to better fit stomas of various sizes.  FIG. 4  shows Stoma Cap  1  configured with several size sealing lip rings  10 , each of which can be removed by tearing off to reveal a smaller ring, until appropriate sizing is achieved.  FIG. 5  shows an embodiment in which the open end sizing of Stoma Cap  1  is achieved by rolling back the lip  11  of the body to a smaller diameter region of the body of Stoma Cap  1 , as needed to fit to the patient&#39;s stoma. 
         [0042]    Referring now to the device as shown in cross section in  FIG. 6 , with an internal chamber  16 , adjacent the open end of Stoma Cap  1 , a second internal chamber  15 , adjacent the closed end of Stoma Cap  1 , a check valve  18  allowing passage of gas from chamber  16  to chamber  15  but not in the other direction, and a check valve  19  allowing passage of gas from chamber  15  to the ambient outside air, but not in the other direction. Squeezing the portion of Stoma Cap  1  in the area of chamber  15  forces air out of that chamber through check valve  19  to the surrounding atmosphere, and releasing that chamber allows it to naturally expand due to the elastic nature of the material of construction of Stoma Cap  1 . In doing so it draws air in from chamber  16  due to the action of said check valves, thus improving the vacuum in chamber  16 . 
         [0043]    Referring to the device as shown in  FIG. 7 , Stoma Cap  1  forms a first enclosed chamber when sealed against patient skin, and a squeezable bulb  20  forms a second chamber, a check valve  18  allows passage of gas from Stoma Cap  1  to bulb  20  through tube  22  but not in the other direction, and a check valve  19  allows passage of gas from bulb  20  to the ambient outside air, but not in the other direction. Squeezing bulb  20  forces air out of that chamber through check valve  19  to the surrounding atmosphere, and releasing that bulb allows it to naturally expand due to the elastic nature of the material of its construction. With expansion it draws air in from Stoma Cap  1  due to the action of said check valves, thus improving the vacuum in Stoma Cap  1 . Tube  22  is additionally detachable from Stoma Cap  1  or bulb  20  such that flange  7 , shown in  FIG. 3 , may be fitted over Stoma Cap  1  as shown in  FIG. 3 . Check valve  18  prevents loss of vacuum upon such detachment of tube  22 . 
         [0044]    Referring now to the device shown in cross section in  FIG. 8 , Stoma Cap  1  has been additionally fitted with a removable liner  30 , folded back over Stoma Cap lip at  31  and substantially retained by strengthened edge rib  32 , discouraging accidental separation from Stoma Cap  1 . Optional absorbent material  2  is shown inside the cavity of the liner which is inside the cavity of Stoma Cap  1 . The removable liner  30  and its contained absorbant material  2  may be provided inexpensively in bulk, sterile, sealed, and ready-to-use packaging, and may be easily disposed of after use. Additional features not shown may include marks on the liner to assist in proper insertion, a flattened feature at lip  31  to improve sealing, and adhesive or other seal assisting substance applied to that surface. 
         [0045]    Referring now to the device shown in cross section in  FIG. 9 , Stoma Cap  1  is shown constructed with a second internally located wall  35 , forming an annular gap  36  at the sealing lip, thus presenting vacuum retention force only to the skin surrounding the stoma rather than pulling vacuum from the stoma itself. In this embodiment, various material selections for flexibilty of the vacuum chamber  37  and the effluent capture chamber  38 , may be used to facilitate forming the vacuum in the vacuum chamber  37  while not substantially deforming the capture chamber  38 . 
         [0046]    Any embodiments and variations of the Stoma Cap may be improved with the addition of adhesive or sealing lubricant to the lip surrounding the open end, and may benefit from the inclusion of absorbent material  2  as in  FIG. 1 ,  FIG. 2 , and  FIG. 8 . 
         [0047]    Stoma Caps may also be designed as a consumable disposable item, possibly pre-loaded with absorbent material, prepared with adhesive on the sealing lip, and requiring no cleaning or sterilizing or handling of the contaminated absorbent material. 
         [0048]    It is to be understood that the embodiments of the invention herein described are merely illustrative of the application of the principles of the invention. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims, which themselves recite those features regarded as essential to the invention.