Abstract:
An adapter insert is for the purpose of reinforcing or stiffening a flexible adapter for said guard system to provide greater support and stabilization in the peristomal region in an effort to help reduce herniation, and to help aid adhesion of a faceplate when worn short term without a guard when output is expected to be minimal, for instance, between meals. The conjoined insert and adapter are positioned between a faceplate and a pouch, their inner apertures surrounding the faceplate flanges or heat weld of an ostomy appliance, and worn under form-fitted clothing negating the need for a security strap.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not applicable. 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       TECHNICAL FIELD 
       [0003]    This invention relates generally to systems for securing ostomy waste collection pouches to the body and preventing leakage of primary securement means. 
       BACKGROUND OF THE INVENTION 
       [0004]    Ileostomies, colostomies, and urostomies are surgically created openings in which a portion of the intestine is brought through the abdominal wall to form a stoma, which may be permanent or temporary depending on the reason for surgery, i.e. disease, injury, birth defects or cancer. A pouching system or ‘appliance,’ as it is sometimes referred to, is used to collect waste material. Pouch styles and sizes vary from manufacturer to manufacturer, however, two main types of pouching systems are available: one-piece pouches with a built in skin barrier (faceplate), and two piece systems comprised of a faceplate and detachable pouch. 
         [0005]    The two-part system provides a flange in the form of a pair of annular or ring-like rigid plastic parts designed to aid in either securing the pouch to the faceplate or removing the pouch at the user&#39;s discretion. Faceplates are further comprised of an adhesive layer formed of a soft, skin-friendly hydrocolloid containing adhesive material and provide therein a centrally located aperture to receive a stoma. Systems may further provide a peel and stick tape on the outer edges of a faceplate for additional adhesion. These faceplates are attached to the peristomal region of the user to protect the skin from irritating digestive juices. A convex faceplate is generally used when a stoma protrudes less than an inch and a flat faceplate is generally used when a stoma protrudes more than an inch. 
         [0006]    Preoperative preparation for a stoma creation includes selection of the most optimal site and consideration is taken not only for skin creases, prior scars, and any bony prominences, but is also based on whether a patient has a flat, muscular abdomen, or an obese abdomen to allow for proper visualization and care. One problem, despite careful planning and individualized considerations, is that pressure from a waistband of jeans or clothing contacting or lying across any part of a faceplate can interfere with the quality of the seal and adherence to the skin of the user threatening a resulting loss of containment. Many other factors influence how long a pouching system will stay sealed. Subsequent leakage of waste can and does occur, often without warning, soiling clothes, causing unpleasant odors and embarrassment to the wearer. 
         [0007]    Another problem faced by ostomates are parastomal hernias. Online research indicates that hernia is essentially caused by expansion of the stoma trephine aperture in the abdominal wall resulting from tangential pressure on the circumference of the opening, often gradually through the passage of time. Ideally, the stoma is brought through the rectus abdominus muscle (six pack muscle) that lies vertically adjacent one&#39;s belly button to reduce the likelihood of a hernia or stomal prolapse but bringing the stoma to the surface of the abdomen immediately creates a weakness and a potential for hernia. Coughing, sneezing, infection from surgery, obesity, weak muscles and the strain upon rising or sitting can cause a bulging at the stoma site with the potential for the muscle or skin of the abdomen to come away from the stoma creating a passageway for the viscera to protrude. 
         [0008]    The size of the hernia generally increases with time, is often uncomfortable and is an embarrassment as its increased size can be seen under clothing and furthermore, it becomes difficult to attach a pouching system properly thereby causing peristomal skin breakdown. A trapped or twisted portion of intestine within the hernia may become obstructed or strangulated and may require emergency surgery to repair. Complicating matters are those who may be elderly, frail, or those for whom an anesthetic would be dangerous because of breathing or heart problems, are at great risk to undergo surgery for repair of the hernia. If the hernia is not causing any symptoms, a wide, firm hernia belt is suggested management. Although these factors are not a comprehensive list of complications, several online medical reports maintain that development of parastomal hernias are nearly an inevitable complication following formation of a stoma. 
         [0009]    If hernia symptoms are severe, or to improve quality of life for an ostomate, methods of hernia repair may include resiting the stoma to a new location, which is a major operation to take down and transfer the stoma from one side to the other. Hernia repair without resiting the stoma may involve opening the adjacent abdominal wall to re-suture muscle and supporting tissues in the area either thru laparotomy or laparascopically. The use of mesh over and beyond the weakened area has been an alternative approach as well as prosthetic devices to keep the mesh from enlarging are used as adjunct to local repair of paracolostomy hernia. 
         [0010]    Psychological struggles are another problem faced by ostomates. Although creation of a stoma is often a life-saving operation, many ostomates fear that others may notice the pouching system or a growing hernia under their clothing, or that a leak in public will cause embarrassment and humiliation resulting in isolation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective view of an exemplary two-piece ostomy appliance comprising a pouch and a faceplate. 
           [0012]      FIG. 2  is a perspective view of a two-piece ostomy appliance of  FIG. 1  and guard system. 
           [0013]      FIG. 3  is a front perspective view of an adapter on the exemplary faceplate of  FIG. 1 &amp; 2 . 
           [0014]      FIG. 4  is an environmental view of a conjoined adapter and insert on the torso of a human. 
           [0015]      FIG. 5  is a front view of a flat adapter insert. 
           [0016]      FIG. 6  is a rear view of a flat adapter insert of  FIG. 5  showing a reinforced edge. 
           [0017]      FIG. 7  is a cross-sectional view of the adapter insert of  FIG. 6   
           [0018]      FIG. 8  is a second embodiment of a cross-sectional view of a sloped adapter insert showing space for a reservoir. 
           [0019]      FIG. 8A  is a cross-sectional view of a sloped insert placed in an adapter. 
           [0020]      FIG. 8B  is a cross-sectional view of a flat insert placed in an adapter. 
           [0021]      FIG. 9  is a third embodiment of a sloped insert having a recessed flow channel in place in an adapter. 
           [0022]      FIG. 10  is a side view of the embodiment of  FIG. 9  placed in an adapter. 
           [0023]      FIG. 11  is a side view of the embodiment of  FIG. 9  as worn with an ostomy appliance on the abdomen. 
           [0024]      FIG. 12  is a rear view of an alternate embodiment of a sloped insert having a plurality of apertures. 
       
    
    
     SUMMARY OF THE INVENTION 
       [0025]    Herein disclosed are adapter inserts for the purpose of reinforcing or stiffening a flexible adapter for a guard system to provide greater support and stabilization in the peristomal region in an effort to help reduce herniation, and to help aid adhesion of a faceplate when worn short term without a complementary guard, while allowing a more sleek profile under clothing when output is expected to be minimal, for instance, between meals. The conjoined insert and adapter are worn between a faceplate and a pouch, their inner aperture surrounding the faceplate flanges of an ostomy appliance (or the heat weld of a one-piece appliance) under form-fitted clothing negating the need for a security strap. 
       DETAILED DESCRIPTION 
       [0026]    Herein disclosed are inserts for an adapter, the adapter being described in a previous application No. 61/506,484 describing a guard system comprising a guard and adapter for an ostomate utilizing a two-piece or one-piece ostomy pouching system (appliance) of the type secured to the body with a faceplate. 
         [0027]    The illustration of  FIGS. 1 and 2  are given to allow for visual understanding of an ostomy appliance system and a guard system and are not the inventions of the present application. 
         [0028]    One such example of an appliance is illustrated in  FIG. 1  and is a typical example of a current, commercially available two-piece ostomy pouching system consisting of a pouch  40 , a pouch flange  42 , belt tabs  44 A and  44 B on either side of the pouch flange; a tab on the upper flange facilitates easy removal, and a fold and lock drain  48  for removal of waste. The two-piece appliance also consists of a faceplate  30 , with coupling flange  34 B and centrally located aperture  36  to receive a stoma  31 . An outer taped portion  32  aids adhesion of an appliance faceplate on the abdomen. 
         [0029]    The ostomy appliance guard system illustrated in  FIG. 2  is comprised of a guard  10  and an adapter  50 . The adapter  50  is provided in various sizes in the centrally located aperture  56  to accommodate the various flange sizes of ostomy appliances currently available, and allows the guard  10  to remain a universal size. Appliance flanges are provided in common sizes between appliance manufacturers, but are not necessarily interchangeable. The adapter  50 , shown already in place, illustrates that flange  42  of pouch  40  is snapped into place with complementary flange  34 B of a faceplate  30 . 
         [0030]    The adapter  50  applied first, having the pouch end  48  guided through the rear of centrally located aperture  56 , is lifted up and over the upper portion of a pouch  41 , and aperture  56  is then circumferentially surrounding the now coupled appliance flanges  42  and  34 B. Adapter support wall  58 , pressing inwardly on flange base  34 A, helps a stoma to protrude while preventing the flanges  42 / 34 B from protruding into the body of the guard  10 . Pouch tabs  44 A,  44 B and  46  may be removed for more efficient use of the guard system  10 / 50 . 
         [0031]    The guard  10  is applied in the same manner as adapter  50 , and pouch end  48  is guided through rear central aperture  16 B of guard  10 , then out through front aperture  16 A, the arrow indicates that guard  10  is then lifted upwards until body  14  of guard  10  encompasses the now engaged flanges including the upper pouch portion  41  (tucked inside guard body in use to prevent intestinal gasses from ballooning above a waistline of pants), and annular ring  12  of guard  10  and adapter  50  snap-fit together, into the adapter&#39;s guard receiving channel  59 , in a mechanical interlock via adapter retaining ribs  55  enabling the guard system  10 / 50  to maintain its position proximate a stoma  31 . 
         [0032]    The body  14  of the guard  10  allows unhindered flow of output. In case liquid output behind the faceplate  30  causes the hydrocolloid adhesive member  38  to loosen from the skin, the hydrocolloid adhesive member  38  may push into a cavity formed by sloping section  57  and support wall  58 , and sealed by guard receiving channel  59  that provides a temporary reservoir for effluent, allowing the user time to change the appliance before escape of output occurs. As can be seen in  FIG. 3 , a guard system  10 / 50  contacts a faceplate  30  more or less than about ¼ in (0.06 cm) inside the outer periphery of said faceplate. Adapter protrusions  52 , on the body-facing side of an adapter  50 , create discontinuous contact on a faceplate  30  facilitating blood flow in the non-contact areas and beneficially reducing an itchiness associated with continuous pressure on the skin. 
         [0033]    Referring to  FIG. 4 , an insert  110  may be used with adapter  50 . Together, insert  110  and adapter  50  may be worn temporarily without a guard under form-fitted clothing to aid adhesion of a faceplate  30 , and to provide support and stabilization in the peristomal region surrounding a stoma. Insert  110  defines a central aperture  114  that essentially encircles the coupling flanges  34 B/ 42  when in use. Insert  110  is placed proximate faceplate  30  inside adapter  50  so that the faceplate flange resides inside apertures  114 / 56  (insert and adapter). When pouch  40  is secured to the faceplate, the coupling flanges  34 B/ 42  are essentially surrounded by the edge of aperture  114 / 56 . Coupling flanges  34 B/ 42  inside aperture  114 / 56  helps insert  110  and adapter  50  maintain its position proximate the stoma. 
         [0034]      FIG. 5  illustrates an adapter insert  110  comprising an annular ring  115 , having a front side  116 A and a back side  116 B (shown in  FIG. 6 ), a central aperture  114 , and holes  112 A and  112 B on either side as a means to attach a belt and a flat outer edge  119  that snap-fits into the adapter&#39;s guard receiving channel  59  when a guard is not in use. The flat outer edge  119  is flush with the adapter&#39;s lip  54  when inserted into the adapter  50  (illustrated in  FIG. 8B ), and being more or less than about ⅓ in (0.029 in) deep, the approximate depth of the adapter&#39;s guard receiving channel  59  measured from the top of lip  54 . The insert  110  is applied in the same fashion as the adapter  50  by guiding pouch end  48  in through aperture  114 , i.e., in through back side  116 B, out through  116 A, and lifting the insert  110  up and over upper pouch  41  and insert  110  snap-fits into adapter  50 , with front side now adjacent a pouch  40 . 
         [0035]    The insert  110  for the adapter  50  can be made of any suitable material that can be suitably formed into the desired configurations including a means to attach a security strap. Security straps are known in the art and may be utilized with the insert  110 . It should be understood that a security strap is not required when the system is worn under form-fitted clothing, i.e., pants, briefs or underwear, but may be a preferred method of increasing support by a user when looser fitting attire is worn. 
         [0036]    The central aperture  114  of insert  110  may otherwise be provided in varied sizes to accommodate various flange sizes of appliances, and preferably in skin tone colors so as not to be noticed under clothing. 
         [0037]    Common flange diameters of appliance faceplates generally range more or less than about 1⅞ inches (47 mm), more or less than about 1¾ inches (44 mm), more or less than about 2¼ inches (57 mm), more or less than about 2¾ (70 mm), and more or less than 4.0 inches (100 mm). 
         [0038]    An overall diameter of an adapter  50  is configured to rest on the outer tape portion  32  of a faceplate  30 . Common and generally square faceplate sizes measured from their peripheral edges may range in diameter approximately more or less than about 1⅞ inch (47 mm) square (infant size), up to more or less than about 4.0 inches (100 mm) square, more or less than about 5.0 inches (127 mm) square, and up to more or less than about 6.0 (152 mm) square, or possibly larger in less common or specially ordered sizes. Circular faceplate diameters or triangular configurations in similar size ranges, as mentioned above, may also be available. 
         [0039]    The adapter inserts may be formed of any suitable material of sufficient rigidity and durability to absorb and divert external impact forces. Examples of suitable materials include various hard plastics, polypropylene, high density polyethylene (HDPE), acrylonitrile butadiene styrene (ABS), PC/ABS (polycarbonate/ABS blend), polybutylene terephthalate (PBT), metals, polymers, fiber-reinforced polymers, non-toxic metal (e.g. stainless steel) or other like materials and combinations thereof that may be extruded, vacuum or injection molded, stamped, cast or formed by any suitable process to provide the desired configurations as explained above and exemplified in the figures. Holes for ventilation purposes may be added to the insert. Additionally, padding (i.e. foam, rubber, thermoplastic elastomers (TPE), thermoplastic vulcanizates (TPV) and combinations thereof) may be used on or over any hard surfaces or molded over the entire exterior surface. Added reinforcement may be added by a pattern, grid, or possibly lettering on the front or back side of the insert or any other reinforcement as may be known in the art may be added to provide a rigid and protective device. 
         [0040]    Referring to  FIG. 6 , the back side of an adapter insert  110  shown in  FIG. 5  is further illustrated. Adapter insert  110  comprises an annular ring  115 , having a front side  116 A (shown in  FIG. 5 ) and a back side  116 B, a central aperture  114 , and holes  112 A and  112 B on either side as a means to attach a belt and a flat outer edge  119  that snap-fits into the adapter&#39;s guard receiving channel  59  when a guard is not in use. The outer edge  119  is flush with the adapter&#39;s lip  54  when inserted into the adapter  50  and being more or less than about ⅓ in (0.029 in) thick, the approximate depth of the adapter&#39;s guard receiving channel  59  measured from the top of lip  54 . The back side  116 B has reinforcing rings  118  and  118 A (or internal vertical reinforcement prong and outer vertical prong) added for strength and rigidity. Reinforcing ring  118 A helps form the outer edge  119 . The insert  110  is applied in the same fashion as the adapter  50  by guiding pouch end  48  in through aperture  114 , i.e., in through back side  116 B, out through  116 A, and lifting the insert  110  up and over upper pouch  41  and insert  110  snap-fits into adapter  50 , with front side now adjacent a pouch  40 . 
         [0041]    The insert  110  for the adapter  50  can be made of any suitable material that can be suitably formed into the desired configurations including a means to attach a security strap. Security straps are known in the art and may be utilized with the insert  110 . It should be understood that a security strap is not required when the system is worn under form-fitted clothing, i.e., pants, briefs or underwear, but may be a preferred method of increasing support by a user when looser fitting attire is worn. 
         [0042]      FIG. 7  illustrates a cross sectional view taken along line  7 - 7  of  FIG. 6 . Adapter insert  110  comprises an annular ring  115 , having a front side  116 A and a back side  116 B, a central aperture  114 , and holes  112 A and  112 B (not shown) on either side as a means to attach a belt and a flat outer edge  119  that snap-fits into the adapter&#39;s guard receiving channel  59  when a guard is not in use. The outer edge  119  is flush with the adapter&#39;s lip  54  when inserted into the adapter  50  and being more or less than about ⅓ in (0.029 in) thick, the approximate depth of the adapter&#39;s guard receiving channel  59  measured from the top of lip  54 . The back side  116 B has reinforcing rings  118  and  118 A added for strength and rigidity. Reinforcing ring  118 A helps form the outer edge  119 . The insert  110  is applied in the same fashion as the adapter  50  by guiding pouch end  48  in through aperture  114 , i.e., in through back side  116 B, out through  116 A, and lifting the insert  110  up and over upper pouch  41  and insert  110  snap-fits into adapter  50 , with front side now adjacent a pouch  40 . 
         [0043]    The insert  110  for the adapter  50  can be made of any suitable material that can be suitably formed into the desired configurations including a means to attach a security strap. Security straps are known in the art and may be utilized with the insert  110 . It should be understood that a security strap is not required when the system is worn under form-fitted clothing, i.e., pants, briefs or underwear, but may be a preferred method of increasing support by a user when looser fitting attire is worn. 
         [0044]    A second embodiment for an insert  110 A for an adapter is shown in  FIG. 8  and comprises a rigid annular ring  115 , having a front side  116 A and a back side  116 B wherein a central aperture  114  is dimensioned to permit a pouch to be inserted therethrough and further having means to connect a security strap by two or more holes adapted to receive a securing strap therethrough or within, or by any means to attach a security strap for the purpose intended. Additional fastening means that would prevent ballooning of a pouch above the waistband of clothing may be in the form of slits, or protrusions or hooks flush with the surface at a 10:00 and 2:00 o&#39;clock position to add a strap, or a hook and loop means to attach for anti-ballooning purposes in this or the flat insert  10 . 
         [0045]    The insert  110 A also comprises a flat outer edge  119  that snap-fits into the adapter guard-receiving channel  59  to maintain a position in the adapter and is alternately not flush with the adapter lip  54 . The back side  116 B has reinforcing rings  118  and  118 A (or internal vertical reinforcement prong and outer vertical prong) added for strength and rigidity. Reinforcing ring  118 A helps form the outer edge  119 . The annular ring  115  also has a sloped support wall  120  in the case liquid output behind the faceplate  30  causes the hydrocolloid adhesive member  38  to loosen from the skin, the hydrocolloid adhesive member  38  may push into a cavity formed by sloped support wall  120  and is sealed by guard receiving channel  59  as pressure is applied to a faceplate  30  from form-fitted clothing and that provides a temporary reservoir for effluent, allowing the user time to change the appliance before escape of output occurs. 
         [0046]      FIG. 8A  illustrates a cross-sectional view of a sloped insert  110 A in place in the adapter  50  showing the sloped insert is not flush with lip  54  of an adapter  50 . 
         [0047]    The insert comprises a rigid annular ring  115 , having a front side  116 A and a back side  116 B wherein a central aperture  114  is dimensioned to permit a pouch to be inserted therethrough and further having means to connect a security strap by two or more holes adapted to receive a securing strap therethrough or within, or by any means to attach a security strap for the purpose intended. The insert  110 A also comprises a flat outer edge  119  that snap-fits into the adapter guard-receiving channel  59  to maintain a position in the adapter and is not flush with the adapter lip  54 . The back side  116 B has reinforcing rings  118  and  118 A (or internal vertical reinforcement prong and outer vertical prong) added for strength and rigidity. Reinforcing ring  118 A helps form the outer edge  119 . The annular ring  115  also has a sloped support wall  120  in the case liquid output behind the faceplate  30  causes the hydrocolloid adhesive member  38  to loosen from the skin, the hydrocolloid adhesive member  38  may push into a cavity formed by sloped support wall  120  and is sealed by guard receiving channel  59  as pressure is applied to a faceplate  30  from form-fitted clothing and that provides a temporary reservoir for effluent, allowing the user time to change the appliance before escape of output occurs. 
         [0048]      FIG. 8B  illustrates an embodiment wherein adapter  50  and sloped insert  110 A do not have a central aperture. There are those ostomates who are able to have a reversal of their condition where a surgically created stoma is re-connected to the intestines allowing the normal function of elimination of bodily wastes. The repaired area of the surgical site may still be susceptible to herniation and a flexible adapter  50  with a flat insert  110  or a sloped insert  110 A could be utilized as support for the weakened site until further healing takes place. 
         [0049]    Alternately, the inserts,  110  or  110 A as exemplified in the figures could be bonded together by any means known in the art to provide a single device and inserts  110  and  110 A may be molded over on the entire exterior surface by any process suitable, such as injection molding, extrusion, co-extrusion processes etc., and adjusted to any size or dimensions to accommodate reversal sites other sutured areas on the abdomen that may be susceptible to herniation and may be oblong, square with rounded corners, flattened egg shape, crescent shape or any other shape allowing one the freedom to bend over comfortably and preferably in skin tone colors as to not be seen under clothing. The insert may be formed of any material suitable and selected from any of the above mentioned plastic or metallic materials but preferably a rigid plastic so as not to be detained or detected by devices that detect metal and used for security purposes such as airports, etc., for peace of mind of the wearer. 
         [0050]    Colostomates have short term circumstances that allow them to practically wear a bandage over their stoma, without a pouch. Also, there are those ostomates who have reversals, where they no longer have a stoma and may be susceptible to a hernia at the closed site, and may wear this support until the site has had time to heal. The flexible adapter and insert may be worn under form-fitted clothing. The insert may be formed in various sizes or shapes to accommodate any surgical site on the abdomen. No central aperture would be needed in this case. 
         [0051]      FIGS. 9 and 10  show a third embodiment of a sloped insert  110 B used with an adapter  50  having a recessed flow channel  121  along a portion of the annular ring. Recessed flow channel  121  has two annular edges, an inner edge and an outer edge. The recessed flow channel  121  is abutted by the sloped support wall  120  along the two annular edges. The recessed flow channel  121  allows for improved flow of output near the opening of the stoma  31  and device aperture  114 , as can be seen more clearly in  FIG. 11 . 
         [0052]      FIG. 11  illustrates how the third embodiment of the device is worn with an ostomy appliance on the abdomen of the wearer. 
         [0053]      FIG. 12  shows another embodiment wherein a sloped insert  110  has a plurality of apertures  122  for ventilation and is provided over a closed ostomy site for further healing or susceptible to herniation, or for protection against blunt force trauma, clothing, pets, children, etc. As with the previous embodiments, the insert may be adjusted to any size or dimensions to accommodate such sites, or other sutered areas, or worn over bandages with pressure relief dressings to cover and protect those sites on the abdomen from waistbands or clothing or may be worn on other parts of the body and held in place by a security strap or hook and loop fastening means.  FIG. 12  does not illustrate a centrally located aperture adapted for the attachment of an ostomy pouch to an ostomy flange, but including the centrally located aperture with this embodiment remains within the scope of the invention. 
         [0054]    While preferred embodiments of the invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the invention. The embodiments described herein are exemplary only, and are not intended to be limiting. 
         [0055]    Many variations and modifications of the invention disclosed herein are possible and are within the scope of the invention.