Patent Publication Number: US-2013253455-A1

Title: Expandable ostomy appliance

Description:
CROSS-REFERENCE TO RELATED APPLICATION DATA 
     This application claims the benefit of priority of Provisional U.S. Patent Application Ser. No. 61/614,258, filed Mar. 22, 201:2 entitled, “EXPANDABLE OSTOMY APPLIANCE.” 
    
    
     BACKGROUND 
     The present disclosure relates to ostomy appliances, and more particularly to stoma caps and ostomy pouches having expandable waste collection capacities. 
     Ostomy appliances for collecting body waste, such as ostomy pouches, are used by patients who have had surgery such as a colostomy, ileostomy, or urostomy. Ostomy pouches typically include flat, opposing side walls secured together along their edges to define a collection cavity. One of the side walls is provided with an opening to receive a stoma, and means to secure the pouch to the user, such as an adhesive barrier, so that body waste discharged through the stoma is received within the cavity. At its lower end, the ostomy pouch may have a discharge opening which may be closed during collection of the body waste material but may be opened for draining the body waste material from the pouch after a period of use. Alternatively, the ostomy pouch may be designed for a single use, in which case it will not be provided with a discharge opening since the entire pouch will be discarded after it has substantially tilled with stomal discharge. 
     Ostomy pouches are available in various sizes for different collecting capacity needs. For example, a user will want to use a large ostomy bag over night, but may desire to use a smaller ostomy pouch for discretion during public activities or when exercising. Occasionally, for example, during exercising, intimacy, or showering, the user may prefer using a smaller device, such as a stoma cap, which is designed to be just large enough to cover the stoma for increased discretion and mobility. 
     Ostomy caps and small ostomy pouches are preferred by users for obvious reasons. However, as stomal discharge cannot be regulated at will, stoma caps and small ostomy pouches often cannot provide sufficient collection capacity to contain a sudden outflow of stomal discharge, resulting in leakage and embarrassment to users. 
     Accordingly, there is a need for an improved stoma cap and ostomy pouch that is small enough to provide the discretion desired by the user, yet can also provide a sufficient collection capacity to contain sudden outflows of stomal discharge. 
     BRIEF SUMMARY 
     An expandable stoma cap and an expandable ostomy pouch are provided according to various embodiments. The expandable stoma cap and the expandable ostomy pouch are small in site in a compacted state to provide a higher degree of discretion for users, and configured to expand to provide an increased waste collection capacity to accommodate sudden outflows of stomal discharge. 
     In one aspect, an expandable ostomy pouch is provided. The expandable ostomy pouch includes a first portion and a second portion. The first portion and the second portion may be defined by a bodyside wall and an outer wall, which may be sealed along their peripheral edges to define a cavity. The cavity may be continuous through the first portion and the second portion. The expandable ostomy pouch also includes an inlet opening arranged on the bodyside wall of the first portion for receiving a stoma. 
     The second portion may be configured to be inverted and inserted within the first portion, such that the second portion is substantially completely hidden and contained within the first portion in a compacted state, and may be substantially completely released and exposed from the first portion in an expanded state. 
     The expandable ostomy pouch may be configured to expand from the compacted state to the expanded state by manually pulling the second portion from the first portion, or due to gravity and/or due to elevated pressure within the pouch due to the introduction of stomal discharge into the pouch, as the cavity is filled with stomal discharge. Further, the first portion and the second portion may be configured such that the second portion is fitted securely within the first portion and the second portion does not release from the first portion during exercise or other user movement without being manually pulled out or expanded by stomal discharge. 
     In one embodiment, the expandable ostomy pouch has a peanut-like shape, in which the first portion has a substantially circular shape and the second portion has a substantially circular shape. In such an embodiment, the second portion may be sized to be slightly smaller than the first portion, such that the second portion can be inverted and securely fitted within the first portion. 
     In another embodiment, the first portion has a substantially square shape and the second portion has a substantially rectangular shape, in which a width of the second portion is smaller than a width of the first portion, and/or a length of the second portion is smaller than a length of the first portion, such that the pouch has substantially the same shape and size as the first portion when in a compacted state with the second portion contained within the first portion. 
     The expandable ostomy pouch can be configured as a drainable pouch including an outlet opening defined at an end of the second portion and a closing means for closing the outlet opening. In this configuration, the outlet opening is closed prior to being inverted and inserted within the first portion in the compacted state. Alternatively, the expandable ostomy pouch can be a “closed” pouch without an outlet opening. 
     In some embodiments, the waste collection capacity of the expandable ostomy pouch in the expanded state is at least 50% greater than that in the compacted state, and preferably at least 100% greater than that in the compacted state. 
     The expandable ostomy pouch can also include a non-woven material arranged on an outer surface of at least one of the bodyside wall and the outer wall, in which the non-woven material extends along the first portion only. 
     In one embodiment, the expandable ostomy pouch further includes an adhesive skin barrier arranged about the inlet opening for attaching the expandable ostomy pouch to a user. Alternatively, the expandable ostomy pouch includes a coupling arranged about the inlet opening for attaching the expandable ostomy pouch to a mating bodyside coupling of an adhesive barrier attached on a user. 
     Further, the second portion of the expandable ostomy pouch can include a tab for facilitating expansion of the pouch from the compacted state to the expanded state. The tab is configured such that a user can grasp the tab and pull out the second portion from within the first portion. In one embodiment, the tab is defined by a heat sealed portion in a lower part of the second portion. 
     In some embodiments, the second portion in the compacted state is attached to the first portion on respective inner surface of the outer wall with a water-soluble adhesive material. 
     In another embodiment, the expandable ostomy pouch includes a filter arranged on an inner surface of the outer wall of the first portion. In such an embodiment, the inverted second portion is arranged between the inlet opening and the filter in the compacted suite to at least partially shield the filter from liquid and solid stomal discharge to extend filter life and enhance filter performance that may otherwise be degraded h partial or total blockage of the filter by stomal discharge. 
     In another aspect, an expandable ostomy cap is provided. The expandable ostomy cap includes a cap portion, which is sized large enough to cover a stoma and to support a means for attaching the expandable ostomy cap to a user. The expandable ostomy cap also includes a tail portion. The cap portion and the tail portion may be defined by a bodyside wall and an outer wall, which may he sealed along their peripheral edges to define a cavity. The cavity is continuous through the cap portion and the tail portion. The expandable ostomy cap also includes an inlet opening arranged on the bodyside wall of the cap portion for receiving a stoma. The tail portion may be configured to be inverted and inserted within the cap portion in a compacted state such that the tail portion is substantially completely contained and hidden within the cap portion, and the second portion may be substantially completely released and exposed from the first portion in an expanded state. 
     In one embodiment, the cap portion has a substantially square shape, in which each side of the cap portion is between about 3.5 inches and about 5 inches. In another embodiment, the cap portion has a substantially circular shape with a diameter between about 3.5 inches and about 5 inches. 
     The cap portion and the tail portion may be configured such that the tail portion is fitted securely within the cap portion and does not expand out of the cap portion during exercise or other user movement without being manually pulled out or expanded by stomal discharge. 
     In one embodiment, a waste collection capacity of the expandable ostomy cap in the expanded state is at least 100% greater than that in the compacted state. 
     In some embodiments, the tail portion is attached to the cap portion in the compacted state on an inner surface of the outer wall of the cap portion with a water-soluble material. 
     Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein: 
         FIG. 1  is a schematic view of an expandable ostomy pouch in an expanded state according to an embodiment; 
         FIG. 2  is a schematic cross-sectional view of the expandable ostomy pouch of  FIG. 1  taken along line A-A; 
         FIG. 3  is a schematic view of the expandable ostomy pouch of  FIG. 1  in a compacted state; 
         FIG. 4  is a schematic cross-sectional view of the expandable ostomy pouch of  FIG. 3  taken along line B-B; 
         FIG. 5  is a schematic view of fan expandable ostomy cap in an expanded state according to an embodiment; 
         FIG. 6  is a schematic cross-sectional view of the expandable ostomy cap of  FIG. 5  taken along line 
         FIG. 7  is a schematic view of the expandable ostomy cap of  FIG. 5  in a compacted state; 
         FIG. 8  is a schematic cross-sectional view of the expandable ostomy cap of  FIG. 7  taken along line D-D: 
         FIG. 9  is a schematic cross-sectional view of an alternate embodiment of the expandable cap in a compacted state; 
         FIG. 10A  is a schematic view of an expandable ostomy pouch including a discharge outlet in an expanded state according to another embodiment; 
         FIG. 10B  is a schematic view of the expandable ostomy pouch of  FIG. 10A  with the discharge outlet closed; and 
         FIG. 11  is a schematic view of an ostomy pouch in an expanded stated according an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiment illustrated. The words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. 
     Referring now to the figures,  FIGS. 1-4  show an embodiment of an expandable ostomy pouch  10 .  FIGS. 1 and 2  illustrate the expandable pouch  10  in an expanded state  12 , and  FIGS. 3 and 4  illustrate the expandable ostomy pouch  10  in a compacted state  14 . The expandable ostomy pouch  10  includes, generally, a pouch  16 , a skin barrier  18 , and a filter  20 . The pouch  16  can be provided in various different sizes. 
     As shown in  FIG. 1 , the expandable ostomy pouch  10  may have a “peanut” shape body  21 , and includes an upper rounded portion  22  and a lower rounded portion  24 . In a preferred embodiment, the upper and lower portions are circular or near-circular. The upper rounded portion  22  has a diameter  26 , which is slightly greater than a diameter  28  of the lower rounded portion  24 , such that the lower rounded portion  24  can be inverted and fit in the upper rounded portion  22  to form the expandable pouch  10  in the compacted state  14 . The upper portion  22  and the lower portion  24  may be configured such that, in the compacted state  14 , the lower portion  24  remains inverted and fitted in the upper portion  22  until a user manually deploys the lower portion  24  by a pulling motion, or the pouch  16  is expanded due to gravity as the pouch  16  is filled with stomal discharge  42 . 
     The pouch  16  may include a bodyside wall  30  and an outer wall  32 , which may be sealed together along their outer peripheral edges  34  to define a cavity  36  for collecting stomal discharge  42 . Each the bodyside wall  30  and the outer wall  32  may be formed of the same material or different materials. For example, each of the walls  30 ,  32  can be formed of a multi layer film, which may be clear or opaque. 
     In some embodiments, a non-woven material may be provided on the outer surface of the bodyside wall  30  and/or the outer wall  32 . 
     The expandable ostomy pouch  10  shown in  FIGS. 1-4  has a closed end  38  without a discharge outlet. In other embodiments, the pouch may include a discharge outlet which may be closed during collection of the stomal discharge and opened for periodic draining of the pouch. For example, the pouch may include an outlet that may be secured in a closed configuration by a separate clamping device, or alternatively, the pouch may include an integrated closure mechanism, such as, for example, one of the closure mechanisms disclosed in Villefrance, et al., U.S. Pat. No. 7,879,015, and Mandzij, et al., U.S. Pat. No. 7,879,016, both of which are commonly assigned with the present application and are incorporated herein by reference.  FIGS. 10A and 10B  illustrate an expandable ostomy pouch  10 ′ including a neck portion  44 ′ with a discharge outlet  46 ′. The neck portion  44 ′ is provided with a closure mechanism  48 ′. In such embodiments, the neck portion  46 ′ is rolled up and securely closed as shown in  FIG. 10B  before a lower rounded portion  24 ′ is inverted and fitted within an upper rounded portion  22 ′ to form the pouch in a compacted state. 
     The bodyside wall  30  may be provided with an inlet opening  40  to receive a stoma. The adhesive skin barrier  18  is arranged about the inlet opening  40  for attachment around the stoma. The expandable pouch  10  may also be provided with filter  20 , such as those disclosed in Nolan, U.S. Pat. No. 3,952,727, and Botten, U.S. Pat. No. 7,559,922, both of which are commonly assigned with the present application and are incorporated herein by reference. 
     In the compacted state  14 , the lower rounded portion  24  may be inverted and fitted within the upper rounded portion  22  as best shown in  FIG. 4 . As such, the walls  30 ,  32  of the lower rounded portion  24  may be positioned between the inlet opening  40  and the filter  20  (which is arranged on an inner surface of the outer wall  32 ), such that the lower rounded portion  24  acts as a barrier to at least partially shield the filter  20  from contact with liquid and solid stomal discharge to extend filter life and enhance filter performance that may otherwise be degraded by partial or total blockage of the filter by stomal discharge. Although the filter  20  is illustrated as attached to the inner surface of the outer wall  32 , in other embodiments, the filter may be attached on an outer surface of the pouch, or the pouch may not include a filter. 
     In use, a user can decide whether to wear the expandable ostomy pouch  10  in the compacted state  14  or in the expanded state  12 . For example, at home, the user may want to wear the expandable pouch  10  in its expanded state  12 , and may want to reduce the size of the pouch  10  to go out or to merely minimize the visual appearance of the pouch. When a smaller pouch is desired, the user can simply push in the lower rounded portion  24  with lingers, such that the lower rounded portion is inverted and fitted within the upper rounded portion. The expandable pouch  10  in its compacted state  14  is small and can provide added discretion in public, yet includes additional waste collection capacity in the contained lower rounded portion. Thus, sudden outflows of stomal discharge can be accommodated. As the stomal discharge fills the cavity  36 , the lower rounded portion  24  expands due to gravity and/or due to elevated pressure within the pouch  10  due to the stomal discharge. Alternatively, the user can choose to expand the pouch  10  by simply pulling out the lower rounded portion  24 . 
     In this embodiment, the lower rounded portion  24  is similarly sized as compared to the upper rounded portion  22 , and thus provides for a greater waste collection capacity than the upper rounded portion  22 . This is because the upper rounded portion  22  includes an inlet opening  40  to receive the stoma, which reduces the waste collection capacity of the upper rounded portion  22  to that volume of the pouch below the stoma. Therefore, it is contemplated that the expandable pouch  10  can provide at least a 100% increase in the waste collection capacity through the lower rounded portion  24 , preferably at least a 120% increase in the waste collection capacity. 
     In some embodiments, the expandable ostomy pouch can include a tab that a user can grasp and pull out the tucked in lower portion to expand the pouch from a compacted state.  FIG. 11  is an illustration of an expandable ostomy pouch embodiment including a tab. An expandable ostomy pouch  10 ″ is configured similar to the expandable ostomy pouch  10  of  FIGS. 1-4 , and has a “peanut” shape body  21 ″ including an upper rounded portion  22 ″ and a lower rounded portion  24 ″. The lower rounded portion  24 ″ includes a tab  50 ″ which can facilitate expansion of the ostomy pouch from a compacted state to an expanded state. In this embodiment, the tab  50 ″ is defined by a heat sealed portion  52 ″ in the lower part of the lower rounded portion  24 ″. Alternatively, the tab can be a separate piece attached to the lower rounded portion by heat sealing, adhesive or other suitable methods. 
       FIGS. 5-8  illustrate an expandable ostomy cap  100  according to another embodiment.  FIGS. 5 and 6  show the expandable ostomy cap  100  in an expanded state  102 , and  FIGS. 7 and 8  show the expandable ostomy cap  100  in a compacted state  104 . The expandable ostomy cap  100  includes, generally, a cap portion  106 , a connecting flange  108  for securing the ostomy cap  100  to an adhesive barrier (not shown) placed around the stoma, and a tail pouch portion  110 . Although expandable ostomy cap  100  is shown with a connecting flange, the expandable ostomy cap  100  can be provided with an adhesive skin barrier in other embodiments. 
     The expandable ostomy cap  100  may be formed of a bodyside wall  114  and an outer wall  116 , which may be sealed along their peripheral edges  118  to define a cavity  120 . The expandable ostomy cap depicted in  FIGS. 5-8  is provided with non-woven layers  115 ,  117  on outer surfaces of the bodyside wall  114  and the outer wall  116  respectively. The non-woven layers  115 ,  117  are optional, and thus, may only be provided on one of the walls or may not be provided in other embodiments. 
     The cap portion  106  is similarly sized as known ostomy caps. For example, the cover portion  106  with a 50 mm diameter circular inlet opening  112  can have a rounded-edge square body  132  with about 4 inches length sides  134 . In another embodiment, the cover portion can have a circular body having a diameter of about 4 inches. 
     To accommodate sudden outflows of stomal discharge, the expandable ostomy cap may be provided with the tail pouch portion  110 . The tail pouch portion  110  may be configured to be inverted and inserted into the cap portion  106 . Thus, the tail pouch portion  110  can be generally sized to be about same as the cap portion or smaller. In the embodiment shown, the expandable ostomy cap  100  is configured such that a length  122  of the tail pouch portion  110  and a length  124  of the cap portion  106  are about equal, and a width  126  of the tail pouch portion  110  is less than a width  128  of the cap portion  106 . In other embodiments, the tail portion may have a length shorter than that of the cap portion, and a width equal to the width of the cap portion. 
     In the compacted state  104 , the tail pouch portion  110  may be inverted and inserted into the cavity  120  of the cap portion  106 , as shown in  FIG. 8 . As such, the expandable ostomy cap  100  in the compacted state has a size approximately equal to that of the cap portion  106 , which is a typical ostomy cap size. Thus, the cavity  120  of the cap portion  106  is expected to have a relatively small collection capacity. However, with the hidden tail pouch portion  110 , the collection capacity of the ostomy cap  100  is significantly increased. In one embodiment, the waste collection capacity of the ostomy cap  100  is increased by at least 50% in the expanded state, preferably by at least 100%, and more preferably by at least 120%. 
     To obtain the larger collection capacity, the user can simply pull out the tail pouch portion  110 , in a similar manner to the expandable ostomy pouch  10 . Alternatively, the user can allow the tail pouch portion  110  to expand due to gravity and/or due to elevated pressure within the cavity  120  due to the stomal discharge as the cavity  120  fills with stomal discharge. 
     In one embodiment, the tail pouch portion  110 ′ in the compacted state  104 ′ can be secured to an inner surface of the outer wall  116 ′ with a soluble film  130 ′. In such an embodiment, the expandable ostomy cap  100 ′ stays in the compacted state  104 ′ until the soluble film  130 ′ comes in contact with stomal discharge, at which time the soluble film  130 ′ is weaken and dissolved by fluid in stomal discharge, thereby releasing the tail pouch portion  110 ′ to expand. The soluble film  130 ′ provides added security in that the tail pouch portion  110 ′ is securely attached to the inner surface of the cap portion  106 ′ during exercise or movement until the expanded collection capacity is needed to accommodate stomal discharge. 
     From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.