Patent Description:
Comfort and security may be primary concerns with regards to the attachment of ostomy devices to a person who has undergone a surgical procedure to create an opening in the body (i.e., ostomate). Attachment features incorporated into, coupled to, or otherwise adapted for use with some ostomy devices may lack a desired degree of comfort and/or conformance. Accordingly, ostomy devices that address those shortcomings remain an area of interest. <CIT> discloses a body side member of an ostomy appliance having a distal surface with one or more pockets holding a manipulable material and allowing the manipulable material to be shifted between a first position and a second position in the pocket in use of the body side member around a stoma of a user.

The present disclosure relates to an ostomy wafer as set out in the claims.

The invention described herein is illustrated by way of example and not by way of limitation in the accompanying figures. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference labels have been repeated among the figures to indicate corresponding or analogous elements.

A number of features described below may be illustrated in the drawings in phantom. Depiction of certain features in phantom is intended to convey that those features may be hidden or present in one or more embodiments, while not necessarily present in other embodiments. Additionally, in the one or more embodiments in which those features may be present, illustration of the features in phantom is intended to convey that the features may have location(s) and/or position(s) different from the locations(s) and/or position(s) shown.

Ostomy wafers of the present disclosure include one or more chambers to contain a viscous media for distribution and/or extrusion through perforations in the ostomy wafers during use. As used herein, the term "chamber" may refer to discrete areas and/or partitioned sections of larger areas, such as the inner space of a convex layer of any ostomy wafer disclosed herein, for example. The chambers contemplated herein may contain, or may be capable of containing, a viscous media. The ostomy wafers disclosed herein may also include one or more perforations in communication with the chamber(s). The ostomy wafers disclosed herein generally include a convex layer and, at least in some embodiment, an internal layer, and the convex layer and/or the internal layer may be perforated. In some instances, the convex layer may be referred to herein as a perforated convex layer and the internal layer may be referred to as a perforated internal layer.

Ostomy wafers disclosed herein may generally be applied quickly without matching up or removing separate or loose elements. The ostomy wafers disclosed herein generally require few steps to apply. In some cases, in a single step, any ostomy wafer disclosed herein may be provided to the user with a chamber already filled with viscous media.

Ostomy wafers disclosed herein generally require minimal dexterity and visual capability in use thereof. In some embodiments, ostomy wafers disclosed herein do not include or require separate or removable elements, which inclusion or requirement might pose a challenge to users with dexterity issues and/or visual issues. In some cases, those users might accidentally leave a removable element in place and/or misuse it.

Ostomy wafers disclosed herein are generally simple for users to use with minimal instruction. Typically, users only apply the ostomy wafer to their skin, possibly with some degree of molding/flexing thereof to accommodate their skin topography. In general, the application of any ostomy wafer disclosed herein includes applying pressure to the chamber to cause viscous media to exit perforations and seal skin to the wafer.

In general, ostomy wafers disclosed herein do not include disposable elements, other than the ostomy wafer itself following use, that is. Thus, ostomy wafers disclosed herein may generate less waste than many devices having other configurations.

<FIG> shows an ostomy wafer <NUM> that includes an external layer <NUM>, a perforated convex layer <NUM>, and, at least in some embodiments, a perforated internal layer <NUM>. The inner space of the convex layer defines a chamber <NUM> for containing viscous media <NUM> (e.g., a paste or gel). A stoma channel <NUM> located within the chamber <NUM> extends from a proximal opening <NUM> to a distal opening <NUM>. In some embodiments, the perforated internal layer <NUM> at least partially surrounds the perforated convex layer <NUM>. When the wafer <NUM> is compressed to the patient's abdomen, the viscous media <NUM> seeps out of perforated holes (e.g., the holes or perforations <NUM> formed in the convex layer <NUM> and/or the internal layer <NUM>), thereby filling skin indentations of peristomal skin and adhering the wafer <NUM> to the patient, at least in some embodiments.

In some embodiments, application of the ostomy wafer to the stoma/ostomate may include extruding the viscous media through the perforations. Additionally, in some embodiments, the viscous media may passively seep through the perforations after application of the ostomy wafer. In some embodiments still, the chamber(s) and/or the perforations may distribute the viscous media to the area surrounding the stoma and/or the area around the ostomy wafer. Consequently, in such embodiments, the viscous media may fill creases and folds in the topography of the skin surrounding the stoma to establish an effective barrier to effluent leakage.

In some embodiments, the ostomy wafers disclosed herein may be moldable. Additionally, in some embodiments, at least a portion of the ostomy wafer may be moldable. In some embodiments still, the ostomy wafers disclosed herein may include a three-dimensional (<NUM>-D) moldable technology. That moldability may allow for additional customization, adaptation, and conformation beyond that provided by the viscous media.

The ostomy wafers disclosed herein may be adjusted to fit a variety of stoma/peristomal skin shapes, conditions, and sizes. The ostomy wafers of the present disclosure are directed to provide a better fit for ostomates and, at least in some cases, moldability to irregular skin contours and folds in addition to the stoma. The ostomy wafers disclosed herein may be especially useful for a stoma adjacent to very pronounced skin irregularities and/or very uneven skin contours. The ostomy wafers herein may also be especially useful for a subject that has recently undergone surgery, due at least in part to their ability to adapt and conform to the patient's abdomen with minimum pressure during application. The ability of ostomy wafers disclosed herein to conform to the stoma and surrounding skin may improve patient comfort, peace of mind, and quality of life.

The ostomy wafers disclosed herein may be moldable and adaptable to stomas and surrounding skin without requiring physical modification to achieve an appropriate and effective fit. Consequently, when compared to the use and application of other devices, a patient may use and apply the ostomy wafers of the present disclosure with confidence of a lower likelihood of embarrassing leakage, infection, and leakage-related skin damage. Additionally, due at least in part to the moldability, designs, and features thereof, the ostomy wafers of the present disclosure may minimize application time for an array of users and make application easier for nurses and patients. This may be desirable for ostomates because application and removal of ostomy skin barrier products can be a time-consuming process.

The ostomy wafers of the present disclosure include at least one chamber (e.g., the chamber <NUM>) to contain any viscous media disclosed herein. In one example, a first chamber immediate to the perforated convex layer (e.g., the convex layer <NUM>) may contain a first compliant viscous media (e.g., one viscous media <NUM>). Alternatively or additionally, a second chamber immediate to the stoma channel or aperture (e.g., the stoma channel <NUM> through which effluent flows and any opening(s) associated therewith) may also contain a second compliant viscous media (e.g., another viscous media <NUM>). In some embodiments, the first compliant viscous media and the second compliant viscous media may be the same. In other embodiments, the first compliant viscous media and the second compliant viscous media may be different from one another. In any case, the viscosity of the viscous media may be relatively high and/or "honey-like" at room temperature. Of course, it should be appreciated that use of heat prior to application to the abdomen may decrease the viscosity of the substance, if needed.

In some embodiments, the ostomy wafers contemplated herein may include, or otherwise be supported by, a combination of structural elements (such as struts, fins, and ties, for example) with material properties (e.g., Young's modulus, creep, and stress relaxation values) to confer physical support and controlled deformation. In some embodiments, the gross diameter of the wafer typically ranges up to about <NUM>, and the height of the ostomy wafer typically ranges from about <NUM> to about <NUM>. Additionally, in some embodiments, the stoma channel may fit stomas ranging in an average dimeter from about <NUM> to about <NUM>.

Advantages of the ostomy wafers disclosed herein relative to other configurations of ostomy devices include a leakage barrier with improved effectiveness due to the combined moldability and convexity of the ostomy wafer (e.g., the convex layer <NUM>), which allows the ostomy wafer to mold to a stoma and accompany irregular skin contours and folds. Thus, the ostomy wafers disclosed herein may provide an improved seal against effluent on the skin to minimize skin irritation and breakdown. It should be appreciated that minimizing the risk of leakage also helps an ostomate feel more confident in his or her ability to manage his or her stoma. In some embodiments, the <NUM>-D moldable technology of the ostomy wafers presented herein may reduce risks of leakages and consequent infection, as well as user distress and discomfort, at least relative to other ostomy wafer configurations. The barrier of any ostomy wafer disclosed herein may include, or otherwise be established by, the external layer, the convex layer, the internal layer, any additional layer(s), portions thereof, and any combinations thereof.

Generally, the ostomy wafers disclosed herein include a primary interface seal that contacts the base of the ileum or the perimeter of the stoma to lessen the likelihood of effluent seeping underneath skin barriers of the ostomy wafers. In addition, the ostomy wafers disclosed herein may be molded to conform to the surrounding peristomal skin and thereby improve the seal to the peristomal skin surface. Thus, the ostomy wafers of the present disclosure may have a conformable design and/or construction to achieve a seal and exhibit malleability and adaptability to their external environment. The primary interface seal of the ostomy wafers contemplated herein may include, or otherwise be established by, the external layer, the convex layer, the inner layer, any additional layer(s), portions thereof, and any combinations thereof. In some embodiments, the primary interface seal and the skin barrier may be the same. In other embodiments, the primary interface seal may be the only part of the ostomy wafer that seals (e.g., resists effluent leakage) the wafer to the ostomate.

The ostomy wafers of the present disclosure are capable of molding to an individual via multiple mechanisms. In one respect, the compliant perforated internal layer (e.g., the internal layer <NUM>), and subsequent inner chambers defined at least partially by the internal layer, are able to conform to the unique surface features of the individual. In another respect, the exuded viscous media may flow into any unfilled areas between the user and the ostomy wafer and function thereby as a sealant. In some embodiments, the viscous media may be embodied as, or otherwise include, a low modulus sealant that provides compliance during a range of activities of daily living (e.g., bending over, walking, lying pronate, and sitting). The conformity and sealant functions may occur at both the skin-wafer interface and the stoma-wafer interface, at least in some embodiments. The ostomy wafer may also include a number of structural features to aid in the establishment of an effective seal at those interfaces (such as a tapered stoma canal, deformable internal structures, and surface profile features, for example). The ostomy wafer may also incorporate moldable technologies to achieve controlled and/or tailored structural deformations to further enhance the seal at the stoma-wafer interface.

While the ostomy wafers disclosed herein are especially advantageous for the management of flush or retracted stomas, the ostomy wafers of the present disclosure may be used for protruding stomas as well. Generally, a protruding stoma is characterized by internal tissue (e.g., ileum) protruding from a surgical opening beyond the surface of surrounding external skin. A flush stoma may be described as protruding internal tissue that is surrounded by skin such that the distal end of the protruding internal tissue is flush with the surrounding skin. Thus, the protruding tissue does not extend beyond the surface of the surrounding skin in the case of a flush stoma. A retracted stoma may be characterized by an absence of protruding internal tissue. In the case of a retracted stoma, the internal tissue does not protrude beyond the perimeter of the stoma or the skin surrounding the stoma.

In the case of a flush stoma, the ostomy wafer may be pressed into and/or against the stoma such that the opening (e.g., the proximal opening <NUM> of the stoma channel <NUM>) of the convex layer surrounds the internal tissue. In some cases, the peristomal skin may be at least partially surrounded by, and/or buried in, the convex layer. In the case of a retracted stoma, the convex layer may be pressed into or against the stoma such that the convex layer is at least partially surrounded by, or buried in, the peristomal skin without the opening of the convex layer surrounding any internal tissue.

Unless defined otherwise, all technical and scientific terms used herein are intended to have, or otherwise employ, the same meaning as would be commonly understood by one of ordinary skill in the art to which the subject matter of the present disclosure belongs. It should be appreciated that the foregoing general description and the following examples are exemplary and explanatory only and not restrictive of any subject matter claimed. The use of a singular form herein includes a plural form unless specifically stated otherwise. More specifically, as used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. The use of "or" in the present disclosure means "and/or" unless stated otherwise. Furthermore, use of the terms "comprising" and "including" as well as other forms (e.g., "comprise," "comprises," "include," and "includes") is not intended to be limiting.

As used herein, ranges and amounts may be expressed as "about" a particular value or range. The term "about" may also include the exact amount. For example, the expression "about <NUM>µL" means "about <NUM>µL" and also "<NUM>µL. " Generally, the term "about" includes an amount that would be expected to be within experimental error. More specifically, the term "about" includes values that are within <NUM>% less than to <NUM>% greater than the specified value. In one example, the expression "about <NUM>%" means "between <NUM>% and <NUM>%. " In another example, the expression "about <NUM>" means "between <NUM> and <NUM>.

As used herein, the terms "individual(s)", "subject(s)," and "patient(s)" refer to any mammal. In some embodiments, the mammal may be a human. Of course, it should be appreciated that in other embodiments, the mammal may be a non-human.

For the purposes of the present disclosure, the term "stoma" refers to an opening in the body. Generally, the stoma is a surgical opening in the torso of the body. In some instances, the term "stoma" may also refer to internal tissue, organs, or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue and/or organs may be selected from the colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine, for example.

Unless specified otherwise, the term "flush/retracted skin" as used herein refers to any skin surrounding the stoma or opening, whether it be external skin, peristomal skin, or a combination thereof. For the purposes of the present disclosure, the term "external skin" refers to skin that is near the stoma but generally not in contact with internal tissues or effluent. As used herein, the term "peristomal skin" refers to skin that is in contact with internal tissues and/or effluent or skin that is likely to contact effluent.

As used herein, the term "ostomate" refers to a subject that may have use of the ostomy wafers of the present disclosure. While the term "ostomate" typically refers to a subject with a surgical opening, as used herein, the term "ostomate" may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means.

The term "ostomy wafer" may be used interchangeably herein with the terms "adapter," "wafer," "perforated convex wafer," "perforated chamber wafer," and "three-dimensional moldable adapter. " Generally, the term "wafer" refers collectively to at least an external layer and a convex layer of the ostomy wafer. Unless otherwise specified, those terms may be used interchangeably. The term "effluent" refers to any internal fluid(s) produced by an ostomate that may be secreted from the stoma or that may exit the stoma.

The devices disclosed herein are adapted for use with a gastrointestinal stoma, at least in some embodiments. Additionally, in some embodiments, the devices disclosed herein may be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, an ureterostomy, or a vesicostomy. In some embodiments still, the devices disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug, or a fecal management system.

It should be appreciated that the section headings contained herein are employed for organization purposes only. As such, the section headings should not be construed as limiting the subject matter described.

In some embodiments, the ostomy wafers of the present disclosure include an external layer (e.g., the external layer <NUM>) having a stoma channel (e.g., the stoma channel <NUM>) that extends from the external layer in a direction perpendicular to (e.g.. , an axial direction) a radial direction of the external layer. Additionally, in such embodiments, the ostomy wafers disclosed herein include a perforated convex layer (e.g., the convex layer <NUM>) through which the stoma channel extends. Furthermore, in such embodiments, the external layer and the convex layer are layered to form a chamber (e.g., the chamber <NUM>) around the stoma channel and within the convex layer to contain a viscous media (e.g., the media <NUM>). These ostomy wafers may be referred to herein as "perforated chamber wafers" as indicated above.

<FIG> and <FIG> show respective ostomy wafers <NUM>, <NUM> with, respectively, external layers <NUM>, <NUM>, perforated convex layers <NUM>, <NUM>, and perforated internal layers <NUM>, <NUM>. The inner spaces of the convex layers <NUM>, <NUM> define corresponding chambers <NUM>, <NUM> (which may be referred to as cores) to contain viscous media <NUM>, <NUM>. Stoma channels <NUM>, <NUM> located within the chambers <NUM>, <NUM> extend from corresponding proximal openings <NUM>, <NUM> to corresponding distal openings <NUM>, <NUM>. The perforated internal layers <NUM>, <NUM> at least partially surround the respective perforated convex layers <NUM>, <NUM>. When the wafers <NUM>, <NUM> are compressed to the patient's abdomen, the media <NUM>, <NUM> seeps out of the perforated holes <NUM>, <NUM> of the layers <NUM>, <NUM> and the layers <NUM>, <NUM>, thereby filling skin indentations of peristomal skin, at least in some embodiments.

In some embodiments, the layers of any ostomy wafer disclosed herein (e.g., the perforated convex layer) may be generally flat before use (e.g., as shipped). The user may mold the ostomy wafer to the degree of convexity required to accommodate the stoma. Thus, the chamber of the convex layer may be created by the molding of the ostomy wafer, at least in some embodiments. The convex layer may have a cylindrical shape, a cupped shape, a bowl shape, a funneled shape, a tubular shape, an irregular shape, or another suitable geometric form. In some embodiments, the user may apply the viscous media to the chamber of the ostomy wafer after molding the ostomy wafer (e.g., filling the "bowl" of the convex layer). In other embodiments, the user may apply the viscous media to the chamber of the ostomy wafer before molding the ostomy wafer.

In some embodiments, the convex layer may be provided in a form that has a desired degree of convexity such that molding by a user is not required. Additionally, in some embodiments, the convex layer may not be moldable. In some embodiments still, the convex layer may have minimal or negligible moldability. In some embodiments yet still, the ostomy wafer may be provided with a convex layer already containing viscous media in its chamber.

In some embodiments, the perforated convex layer may be described as having a proximal opening (e.g., the opening <NUM> at a base of a "bowl" defined by the convex layer <NUM>) and a distal opening (e.g., the opening <NUM> at a "rim" of the bowl defined by the convex layer <NUM>). The convex layer may be thicker near the distal opening than the proximal opening, at least in some embodiments. In one example, the thickness of the convex layer near the proximal opening may be up to <NUM>% of the thickness of the convex layer near the distal opening. The chamber wall may be thicker near the proximal opening than the distal opening, in some embodiments. Additionally, in some embodiments, the thickness of the chamber wall may vary between <NUM> to <NUM>. The distal opening may be concentric with the opening(s) of the external and/or internal layers, at least in some embodiments. In other embodiments, the distal opening may be non-concentric with the opening(s) of the external and/or internal layers. The distal opening may be joined with the opening(s) of the external and/or internal layers and/or indistinguishable from the opening(s) of the external and/or internal layers, at least in some embodiments.

Generally, the external layer (e.g., the external layer <NUM>) and the convex layer (e.g., the convex layer <NUM>) are layered or nested such that the stoma channel (e.g., the stoma channel <NUM>) is positioned within the interior of the convex layer as suggested in <FIG>. The convex layer may include multiple layers arranged in one of a number of layer arrangements. By way of non-limiting example, as shown in <FIG>, the layer arrangements include a concentric arrangement <NUM>, a radial arrangement <NUM>, an internal-external arrangement <NUM>, and a proximal-distal arrangement <NUM>. Additionally, the convex layer may include structure(s) that provide one of a number of profiles and impart support and/or rigidity to the convex layer as a whole, or to one of more chambers of the convex layer. By way of non-limiting example, the profiles include a continuous profile <NUM>, a stepped profile <NUM>, a combined profile <NUM>, and an inverted profile <NUM>. Furthermore, each of the profiles may include various aspects or features. By way of non-limiting example, each of the profiles may include convex aspect or features <NUM>, concave aspects or features <NUM>, chamfered aspects or features <NUM>, or combinations thereof.

The chamber of the convex layer (e.g., the chamber <NUM>) may be centrally or eccentrically placed relative to the stoma aperture (e.g., the stoma channel <NUM>). The chamber may have a proximal chamber opening (e.g., the opening <NUM>) that is positioned within the interior of the convex layer. Prior to use, the chamber may occupy between <NUM> and <NUM>% of the total volume of the ostomy wafer, at least in some embodiments. Upon use, the chamber may occupy between <NUM> and <NUM>% of the total volume of the ostomy wafer, at least in some embodiments.

The ostomy wafer may include an internal layer that at least partially covers the convex surface of the convex layer and has an adhesive on a stoma-facing side thereof for attachment to the peristomal skin (which may adhere the internal layer to flush/retracted skin of the flush/retracted stoma and secure the ostomy wafer to the ostomate). The internal layer may include one or more perforations for passage of the viscous media therethrough and on to the peristomal skin.

The ostomy wafers of the present disclosure include at least one perforation (e.g., the perforations <NUM>) as indicated above. Generally, the convex layer and/or the internal layer include one or more perforations sized appropriately for the dimensions of the ostomy wafer. In one example, one or more of the perforations may range from about <NUM> to about <NUM> in diameter. In another example, one or more of the perforations may range from about <NUM> to about <NUM> in diameter. In yet another example, one or more of the perforations may range from about <NUM> to about <NUM> in diameter.

It should be appreciated that the dimensions of the perforations should be appropriate for the viscous media to seep out from, or be extruded from, the ostomy wafer such that the viscous media reaches the peristomal skin. By way of non-limiting example, the width or diameter of the perforations may range from less than a millimeter to as great as one centimeter, at least in some embodiments. In some cases, the perforations may be numerous, but microscopic in size. In other cases, the perforations may be few, but on a centimeter scale. The spacing of the perforations from one another can range from less than a millimeter to two centimeters. The non-perforated area between perforations may cover up to <NUM>% of an area of the external layer, the convex layer, and/or the internal layer. The perforations may be sized and spaced from one another to ensure a relatively even distribution of the viscous media to the abdomen when an ostomy wafer is applied thereto. The perforations may be arranged in a number of patterns, such as a vertical pattern, a horizontal pattern, an oblique pattern, a spiral pattern, a staggered pattern, or an irregular pattern, for example.

The perforations may be distributed evenly throughout the convex layer and/or internal layer, at least in some embodiments. Additionally, in some embodiments, the perforations may be distributed and/or concentrated in a portion of the convex layer and/or the internal layer. By way of non-limiting example, the perforations may be distributed in a portion of the convex layer and/or the internal layer that is closest to the external layer. In some cases, it may be undesirable to contact internal tissue with viscous media. Rather, it may be preferable to contact only peristomal skin or predominantly peristomal skin with the viscous media, at least in some cases. Therefore, the perforations may be distributed in a region or portion of the convex layer and/or internal layer that is closest to the external layer.

In some embodiments, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Additionally, in some embodiments, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments still, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments yet still, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments still, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments yet still, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Further, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer, at least in some embodiments. Finally, in some embodiments, the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, the majority of the perforations may be distributed in the portion of the convex layer and/or the internal layer that is closest to the external layer. In one example, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In another example, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In yet another example, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In yet another example still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Additionally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Further, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Finally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, the majority of the perforations may be distributed in the portion of the convex layer and/or the internal layer that is closest to the external layer. In one example, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In another example, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In yet another example still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Finally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Additionally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments yet still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Finally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Additionally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or internal layer that is closest to the external layer. In some embodiments still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments yet still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Finally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Additionally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments yet still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Additionally, in some embodiment, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. In some embodiments yet still, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer. Finally, in some embodiments, at least about <NUM>% of the perforations may be distributed over at least about <NUM>% of the convex layer and/or the internal layer that is closest to the external layer.

In some embodiments, the perforations may be circular, oblong, rectangular, square, polygonal, triangular, octagonal, hexagonal, or irregular-shaped. In other embodiments, the perforations may take the shape of another suitable geometric form. The perforations may be slits or cracks, at least in some embodiments. The ostomy wafer, or any portion thereof with the perforations, may resemble a sieve, net, grid, filter, sponge, or the like, at least in some embodiments.

In some embodiments, the sizes of the perforations may vary at different locations on the wafers. By way of non-limiting example, perforations on the convex layer may be larger near the proximal opening (e.g., the opening <NUM>) than perforations on the convex layer near the distal opening (e.g., the opening <NUM>). In other embodiments, however, perforations on the convex layer may be smaller near the proximal opening than perforations on the convex layer near the distal opening. The perforations may have an average range from about <NUM> to about <NUM> in diameter, at least in some embodiments. Additionally, in some embodiments, the perforations may have an average range from about <NUM> to about <NUM> in diameter.

The ostomy wafers of the present disclosure may include a single chamber or multiple chambers. In one example, the ostomy wafer may include one chamber. In another example, the ostomy wafer may include two chambers. In yet another example, the ostomy wafer may include three chambers. In yet another example still, the ostomy wafer may include four chambers. Further, in some embodiments, the ostomy wafer may include five chambers. In some embodiments still, the ostomy wafer may include six chambers. In some embodiments yet still, the ostomy wafer may include seven chambers. The ostomy wafer may include eight chambers, at least in some embodiments. Further, in some embodiments, the ostomy wafer may include nine chambers. Additionally, the ostomy wafer may include ten chambers, at least in some embodiments. Finally, in some embodiments, the ostomy wafer may include twelve chambers.

In some embodiments, the ostomy wafer disclosed herein may include from one chamber to about twenty chambers. In one example, the ostomy wafer may include from two chambers to about twenty chambers. In another example, the ostomy wafer may include from three chambers to about twenty chambers. In yet another example still, the ostomy wafer may include from four chambers to about twenty chambers. Finally, in another example, the ostomy wafer may include from five chambers to about twenty chambers.

The ostomy wafers of the present disclosure may include one or more chambers in which one or more dividers, walls, ridges, grooves, sections, or any other space defining features are arranged. In some embodiments, the ostomy wafer may include a first chamber and a second chamber that are arranged side-by-side as they encircle an opening of any one of the layers, or as they radiate from an opening of any one of the layers. Additionally, in some embodiments, the first chamber and the second chamber may be concentrically arranged as they radiate from an opening of any one of the layers.

Multiple chambers of the ostomy wafers of the present disclosure may allow for viscous media to be present in a first portion of the convex layer and not present in a second portion of the convex layer, at least in some embodiments. In other embodiments, multiple chambers may allow for viscous media to be present in a first amount in a first portion of the convex layer and present in a second amount in a second portion of the convex layer. In one example, the first portion may be about <NUM>% of the convex layer. In another example, the first portion may be about <NUM>% of the convex layer. In yet another example, the first portion may be about <NUM>% of the convex layer. In yet another example still, the first portion may be about <NUM>% of the convex layer. Further, in another example, the first portion may be about <NUM>% of the convex layer. Further, in yet another example, the first portion may be about <NUM>% of the convex layer. Further, in yet another example still, the first portion may be about <NUM>% of the convex layer. The first portion may be about <NUM>% of the convex layer, at least in some embodiments. Finally, in some embodiments, the first portion may be about <NUM>% of the convex layer.

In some embodiments, the aforementioned second portion may be about <NUM>% of the convex layer of any ostomy wafer disclosed herein. Additionally, in some embodiments, the second portion may be about <NUM>% of the convex layer. In some embodiments still, the second portion may be about <NUM>% of the convex layer. In some embodiments yet still, the second portion may be about <NUM>% of the convex layer. Further, in some embodiments, the second portion may be about <NUM>% of the convex layer. Further, in some embodiments still, the second portion may be about <NUM>% of the convex layer. Further, in some embodiments yet still, the second portion may be about <NUM>% of the convex layer. The second portion may be about <NUM>% of the convex layer, at least in some embodiments. Finally, in some embodiments, the second portion may be about <NUM>% of the convex layer.

In some embodiments, the aforementioned first amount may be about <NUM>% of the convex layer of any ostomy wafer of the present disclosure. Additionally, in some embodiments, the first amount may be about <NUM>% of the convex layer. In some embodiments still, the first amount may be about <NUM>% of the convex layer. In some embodiments yet still, the first amount may be about <NUM>% of the convex layer. Further, in some embodiments, the first amount may be about <NUM>% of the convex layer. Further, in some embodiments still, the first amount may be about <NUM>% of the convex layer. Further, in some embodiments yet still, the first amount may be about <NUM>% of the convex layer. The first amount may be about <NUM>% of the convex layer, at least in some embodiments. Finally, in some embodiments, the first amount may be about <NUM>% of the convex layer.

The previously mentioned second amount may be about <NUM>% of the convex layer of any ostomy wafer disclosed herein, at least in one example. In another example, the second amount may be about <NUM>% of the convex layer. In yet another example, the second amount may be about <NUM>% of the convex layer. In yet another example still, the second amount may be about <NUM>% of the convex layer. Further, in another example, the second amount may be about <NUM>% of the convex layer. Further, in yet another example, the second amount may be about <NUM>% of the convex layer. Further, in yet another example still, the second amount may be about <NUM>% of the convex layer. The second amount may be about <NUM>% of the convex layer, at least in one example. Finally, in another example, the second amount may be about <NUM>% of the convex layer.

In some embodiments, the ostomy wafers of the present disclosure may include multiple chambers arranged such that two chambers containing viscous media are separated by at least one chamber not containing viscous media. Additionally, in some embodiments, two chambers containing viscous media are continuous or consecutive. It should be appreciated that multiple chambers may facilitate application of viscous media (e.g., by the user or ostomate) in select regions around the device and/or stoma of the user.

In some embodiments, the volume of viscous media in the chamber may range up to <NUM>% of the total ostomy wafer volume. Additionally, in some embodiments, chamber size may vary with ostomy wafer size, and convexity may range from <NUM>% of total volume up to <NUM>% of total ostomy wafer volume. In some embodiments still, chamber size may range from about <NUM>% of total volume up to <NUM>% of total ostomy wafer volume. In some embodiments yet still, chamber size may range from about <NUM>% of total volume up to <NUM>% of total ostomy wafer volume. Further, in some embodiments, chamber size may range from about <NUM>% of total volume up to <NUM>% of total ostomy wafer volume. Further, in some embodiments still, chamber size may range from about <NUM>% of total volume up to <NUM>% of total ostomy wafer volume. Finally, in some embodiments, chamber size may range from about <NUM>% of total volume up to <NUM>% of total ostomy wafer volume.

In some embodiments, the ostomy wafers disclosed herein may include features to control deformation thereof in use. The features may include, but are not limited to, struts, fins, walls, columns, and combinations thereof (e.g., in the order of <NUM> to <NUM> in their greatest dimension). In one example, the ostomy wafer may include structures <NUM> shown in <FIG> that are embodied as, or otherwise include, angled and/or tapered surfaces <NUM>, <NUM>. In some embodiments, the surfaces <NUM>, <NUM> may define, or otherwise incorporate, one or more angled fins <NUM> defining notches <NUM> therebetween, which are depicted in <FIG> and which may be embodied as, or otherwise included in, the structures <NUM>. In any case, in some embodiments, each angled fin <NUM> and/or each notch <NUM> may have a height H (shown in <FIG>) of about <NUM> to about <NUM>. The height H may be the dimension perpendicular to a length L of the stoma channel (e.g., the stoma channel <NUM>). As shown in <FIG>, each angled fin <NUM> may have a width W1 measured with respect to a horizontal line <NUM> that is from <NUM> to <NUM> and a width W2 measured with respect to the line <NUM> that is from <NUM> to <NUM>. Additionally, as shown in <FIG>, each angled fin <NUM> may extend at an angle A relative to the line <NUM> that is from <NUM>° to <NUM>° and at an angle B relative to the line <NUM> that is from and angle B is <NUM>-<NUM>°.

In some embodiments, ostomy wafers disclosed herein may include structures (e.g., the structures <NUM>) located on the inner wall(s) defining the stoma channel that facilitate controlled deformation of the ostomy wafer in use thereof. Additionally, in some embodiments, the structures disclosed located on the inner surface of the stoma channel are tapered (e.g., the structures <NUM>) or jagged (e.g., the structures <NUM>), which may prevent or resist detachment of the ostomy wafer from the protruding stoma, at least in some embodiments. In some embodiments still, the structures disclosed herein provide internal structures (e.g., the structures <NUM> within the stoma channel wall(s) <NUM>) that provide deformation and malleability without gripping and/or directly contacting the stoma.

In some embodiments, the ostomy wafers of the present disclosure may include a structural support to achieve optimum convexity upon dispersal of the viscous media. Additionally, in some embodiments, the structural support may produce greater stomal protrusion and provide enhanced protection for recessed, retracted, or flush stomas. Structural supports may include one or more of various materials. By way of non-limiting example, those materials may include rigid or semi-rigid plastics such as polypropylene, polystyrene, or polyethylene (e.g., polyethylene-vinyl acetate), at least in some embodiments.

In similar fashion to the arrangements of the multiple layers of the convex layer described above with reference to <FIG>, a plurality of support structures may be arranged radially, concentrically, in proximal-distal layers, or in internal-external layer, at least in some embodiments. The support structures may be present at a macro level (with dimensions of several mm) and at a micro level (in the order of µm). Additionally, in some embodiments, the support structures may function to control gross structural deformation to within about <NUM>% of original ostomy wafer volume. In some embodiments still, the surface profile of the ostomy wafer may contain features to guide movement of, and/or control distribution of, viscous media, such as corrugated peaks and troughs in regular or irregular patterns, for example. Those features may vary in height from <NUM> to <NUM>. Furthermore, the ostomy wafer may have surface texture with a surface roughness Ra (µm) ranging from <NUM> to <NUM>.

Deformation characteristics of the ostomy wafers disclosed herein may be anisotropic, at least in some embodiments. In most cases, however, that deformation is below about <NUM> and about <NUM>% of total ostomy wafer volume. Adhesive components may fill structural voids having a minimum volume of about <NUM><NUM>, at least in some embodiments. Additionally, in some embodiments, adhesive components may fill structural voids having a minimum size of about <NUM><NUM>. In some embodiments, adhesive components may fill structural voids having a minimum size of about <NUM><NUM>.

The illustrative, three-dimensional, moldable ostomy wafers of the present disclosure generally include adhesives or adhesive layers. As used herein, the term "adhesive" refers to layers, fabrics, strips, laminates, barriers, gels, pastes, hydrocolloids, glues, or the like that may be used to promote adherence of the ostomy wafer to the ostomate and/or promote a seal between the ostomy wafer and the ostomate to resist undesirable leakage of effluent.

The adhesives disclosed herein may be substantially liquid impermeable and may permeate moisture away from the skin, at least in some embodiments. The adhesives may have a moisture vapor transmission rate (MVTR) greater than <NUM>/m<NUM>/<NUM>, greater than <NUM>/m<NUM>/<NUM>, or greater than <NUM>/m<NUM>/<NUM>. Additionally, in some embodiments, the adhesives may have a MVTR greater than <NUM>/m<NUM>/<NUM>.

In some embodiments, the adhesives may include a polymer selected from, but not limited to, polypropyleneoxide, polyurethane, silicone, polyacrylate, ethylene vinyl acetate and combinations thereof. Additionally, in some embodiments, the adhesive may include a hydrocolloid. The adhesive may be at least <NUM>%, at least <NUM>%, at least <NUM>%, at least <NUM>%, at least <NUM>%, or at least <NUM> % w/v hydrocolloid, but less than <NUM>% w/v hydrocolloid, at least in some embodiments. In some embodiments still, the adhesive may include a salt. In such embodiments, the salt may be selected from sodium chloride, calcium chloride, potassium sulfate, sodium bicarbonate, disodium carbonate, potassium chloride, sodium bromide, sodium iodide, potassium iodide, ammonium chloride, and aluminum chloride.

The adhesive may include a sealing substance that promotes a seal between the ostomy wafer and the stoma/ostomate, at least in some embodiments. It should be appreciated, however, that in some embodiments, inclusion of an adhesive in the ostomy wafer may be unnecessary. In some embodiments, kits and/or methods contemplated by the present disclosure may include an adhesive or involve the use of an adhesive, and the adhesive (e.g., an adhesive paste) may be applied to the ostomy wafer to effectively eliminate gaps between the stoma and the ostomy wafer in use of the ostomy wafer.

Adhesives may also be used to promote adherence of an ostomy pouch to the ostomy wafer. The adhesives disclosed herein may provide adhesion for a variety of skin conditions, as well as security and comfort for the patient. In some embodiments, to ensure the skin barrier adheres to moist/dry skin, hydrocolloids may be used. Additionally, in some embodiments, the adhesives, such as barriers, seals, strips, laminates, or fabrics, for example, may include a release liner designed for removal prior to use. In other embodiments, however, the adhesives may not include a release liner. In such embodiments, the adhesive quality of the adhesive may be present only when the adhesive makes contact with a liquid, gel, effluent, skin, heat, or a combination thereof. Furthermore, in some embodiments, the adhesives may have an adhering, sealing, or molding quality that is activated and/or promoted by heat and/or contact with effluent.

Adhesives disclosed herein may include a component or material selected from, but not limited to, chitosan, pectin, gelatin, carboxymethylcellulose, a butadiene polymer, a poly-α-olefin, an absorbent microcolloid particle, a cross-linked hydrophilic polymer, a p-toluene-suffonamide, a polymeric matrix, a thermoplastic elastomer, a polyolefin elastomer, a copolymer of ethylene and octane, a silicone elastomer, carboxymethyl cellulose, an acrylate, an alginate, a polysaccharide, a homopolymer, a block co-polymer, a hydrogel-forming hydrophilic homopolymer, a heteropolymer, an amphiphilic block-copolymer, a cross-linked polyalkyleneoxide polymer, a triblock copolymer, a plasticising oil (e.g., liquid rosin derivative, aromatic olefin oligomer, vegetable or animal oil, ester, ether, glycol, poly propylene oxide, alpha-butoxy-polyoxypropylene), a polar polyethylene copolymer, a polypropyleneoxide, a polar polyethylene copolymer, ethylene vinyl acetate, ethylene vinyl acetate carbon monoxide, ethylene butyl acetate, ethylene vinyl alcohol, ethylene butyl acrylate, ethylene butyl acrylate monoxide, a styrene-isoprene-styrene copolymer, a tackifier, paraffin oil, a hydrocolloid, a mono-oligosaccharide, a di-oligosaccharide, a sugar alcohol, a polypeptide, an organic acid, an inorganic acid, an amino acid, an amine, urea, and a glycol, and combinations thereof.

In an exemplary embodiment, the ostomy wafers disclosed herein may include ConvaTec Moldable adhesive Technology (CMT), which improves the fit between skin barriers and stomas. In one example, Durahesive™ technology used in CMT may help to protect the skin from caustic effluent. Durahesive™ technology combines the ingredients used in Stomahesive™ technology in a different ratio to produce a moisture-absorbing adhesive. In some embodiments, the inclusion of Durahesive™ technology in convex wafers may ensure easy one-piece removal (i.e., due to higher cohesive strength) that is gentle on the surrounding skin. Durahesive™ polymers may swell within an elastic matrix to create a seal around the stoma site. Durahesive™ polymers may swell or "turtleneck" in response to coming in contact with liquid effluent to improve the seal around the stoma. The expansion and contraction around the stoma in use of such polymers may provide a barrier that remains snug and secure during period of wear. It should be appreciated that ensuring a good seal around the stoma minimizes the risk of effluent leaking under the skin barrier, and that reducing such leakage resists the development of peristomal skin complications.

In an exemplary embodiment, the ostomy wafers disclosed herein may include ConvaTec Moldable adhesive Technology (CMT), which improves the fit between skin barriers and stomas. In one example, Durahesive™ technology used in CMT may help to protect the skin from caustic effluent. Durahesive™ polymers may swell within an elastic matrix to create a seal around the stoma site. Durahesive™ polymers may swell or "turtleneck" in response to coming in contact with liquid effluent to improve the seal around the stoma. The expansion and contraction around the stoma in use of such polymers may provide a barrier that remains snug and secure during period of wear. It should be appreciated that ensuring a good seal around the stoma minimizes the risk of effluent leaking under the skin barrier, and that reducing such leakage resists the development of peristomal skin complications.

In some embodiments, the ostomy wafers disclosed herein and components thereof may include a hydrocolloid adhesive, such as Pectin, Gelatin, and NaCMC (Sodium Carboxymethyl Cellulose), for example. The term "hydrocolloid adhesive" as used herein refers to an adhesive material or substance that includes a hydrocolloid. Exemplary embodiments of hydrocolloid adhesives include, but are not limited to, Stomahesive™, Durahesive™, Trilaminate, and Stomahesive™ Seal. The formulation of those adhesives may be altered to increase further the product's appeal (e.g. comfort, flexibility, size, breathability, etc.). To improve the elasticity of the adhesive, an addition of a material (e.g., styrene-isoprene-styrene (SIS) rubber, isobutylene, etc.) may be added. Oils may also be added to enhance the pliability and tack. As used herein, any reference to "Trilam" generally refers to a trilaminate system. Furthermore, as used herein, any reference to "Trilam SH/DH" generally refers to a trilaminate system that incorporates a Stomahesive™ (SH) layer, a film layer, and a Durahesive™ (DH) layer. In some cases, the film layer may be embodied as, or otherwise include, a layer incorporating PET film.

The adhesives disclosed herein may include a mucoadhesive. The mucoadhesive may be particularly helpful to maintain sufficient adhesion under wet conditions, among other conditions. In some embodiments, the mucoadhesive of the present disclosure includes a polymer having functional groups selected to provide adhesion to the skin and the stoma. In one example, the functional groups are selected from a group consisting of thiols, acids and their salts, iminothiolanes, thioalkylamidines, catechols, amino acids, dihydroxy substituted aromatic groups, and combinations thereof. Additionally, in one example, the polymer is a biocompatible polymer made from natural or synthetic polymer selected from a group consisting of polyacrylates, polyakylmethacrylates, polyphenylmethacrylate, polyanhydrides, styrenic block copolymers, polyamides, polyesters, polyvinyl ethers, polyvinyl esters, sulfonated polymers, polyolefins, silicones, polyvinylpyrrolidones, polyvinylacetate and its copolymers, polyvinyl acohol, polyurethanes, polyethers, copolymers of maleic anhydride, polysaccharides, polypeptides, gelatin, alginates, gums, starch, chitosan, pectin, and combinations thereof. Further, in some embodiments, the mucoadhesive may contain other components such as hydrophobic polymers, hydrophilic polymers, amphiphilic polymers, tackifiers, resins, plasticizers, hydrocolloids, inorganic and organic particulate fillers, antioxidants, stabilisers, organic and inorganic pigments, lubricious additives, and combinations thereof.

The adhesives may include a pressure sensitive adhesive having one or more amphiphilic copolymers of polydimethylsiloxane, at least in some embodiments. In such embodiments, the copolymer may be prepared using a polydimethylsiloxane or polymethylhydrogensiloxane macroinitiator and at least one reactive hydrophilic or amphiphilic monomer, oligomer, macromere, or combinations thereof. In some embodiments, the reactive hydrophilic or amphiphilic monomer may be selected from a group consisting of N-vinyl caprolactams, vinyl esters, vinyl ethers, unsaturated acids or anhydrides and their salts, acrylates, methacrylates, acrylamides, methacrylamides, N-alkyl acrylamides, cyanate esters, hydroxy-alkyl acrylamides, glycidyl esters, glycidyl ethers, allyl monomers, and combinations thereof.

Viscous media (e.g., viscous media <NUM>) may also be referred to as one or more viscous solutions. Viscous media may be sticky or adhesive to promote adherence and establish a seal between the wafer and the ostomate, at least in some embodiments. Viscous media may include a paste and/or gel. Non-limiting examples of pastes include ConvaTec's Stomahesive™ paste, Adapt Paste (Hollister), Brava Paste (Coloplast), Securiti-T Stoma Paste (Genairex), MicroHesive Stoma Paste (Cymed), and Osto Stoma Paste (Montreal Osto). Gels include, but are not limited to, Silicone Gel (Trio), and Osto Paste (Stoma-Tech). Additionally, in some embodiments, ingredients of the pastes/gels may include, but are not limited to, Sodium Carboxymethylcellulose, Thixcin, Gelatin, and Pectin.

Viscous media, as contemplated herein, may have a viscosity of about <NUM> Pa. s-<NUM> to about <NUM> Pa. s-<NUM> at room temperature (-<NUM>), at least in some embodiments. Additionally, in some embodiments, the viscous media may have a viscosity of about <NUM> to about <NUM> Pa. s-<NUM> at room temperature. In some embodiments still, the viscous media may have a viscosity of about <NUM> to about <NUM> Pa. s-<NUM> at room temperature. In some embodiments yet still, the viscous media may have a viscosity of about <NUM> to about <NUM> Pa. s-<NUM> at room temperature. Further, in some embodiments, the viscous media may have a viscosity of about <NUM> to about <NUM> Pa. s-<NUM> at room temperature. Finally, in some embodiments, the viscous media may have a viscosity of about <NUM> to about <NUM> Pa. s-<NUM> at room temperature.

The viscous media may have a honey-like viscosity, a nectar-like viscosity, or a molasses-like viscosity at room temperature, at least in some embodiments. Additionally, in some embodiments, the viscous media may have a viscosity similar to peanut butter, lard, ketchup, or toothpaste at room temperature. In some embodiments still, the viscous media may have a honey-like viscosity, a nectar-like viscosity, or a molasses-like viscosity at body temperature (-<NUM>). Furthermore, it should be appreciated that in some embodiments, the viscous media may have a sufficiently high viscosity for the viscous media to be pushed/extruded through, seep through, or flow through perforations of the ostomy wafer. Further still, the viscous media may have a sufficiently low viscosity for the viscous media to be maintained at the site of use (e.g. stoma), subsequent to placement of the wafer/ostomy wafer. Of course, the viscosity of the viscous media may vary with temperature (e.g., room temperature to body temperature), shear stress, or manipulation of the viscous media. In some instances, movement of the wafer or the subject may provide additional adhesion.

In some embodiments, the viscous media may seep through the perforations, spread into skin depressions/contours, or otherwise resist effluent leakage. Additionally, as indicated above, the viscous media may be extruded through perforations of the ostomy wafers. In some embodiments still, to achieve optimum function, the ostomy wafer may incorporate a viscous media selected on the basis of any one of the following: dimensional stability, time dependent curing, temperature dependent curing, pH activation, light/UV activation, chemo-activation, and an oxidative property. In some embodiments yet still, the viscous media may be hydrophobic, hydrophilic or amphipathic.

The ostomy wafers disclosed herein generally include multiple layers. The layers may include, but are not limited to, molds, adhesives, seals, barriers, and laminates. In some embodiments, any one of the layers may include a foam. The foam may be an open cell foam, at least in some embodiments. It should be appreciated that solutions or fluids used with the ostomy wafers disclosed herein may seep through the open cell foam or may be extruded through the open cell foam.

The ostomy wafers disclosed herein include an external layer that may be flexible or moldable, at least in some embodiments. The external layer may allow a user of the ostomy wafer to depress the external layer into the convex layer or chamber, thereby decreasing the volume of the chamber and extruding the viscous media through the perforations, at least in some embodiments. In one example, the external layer may include a single layer. In another example, the external layer may include a multilayer or multi-laminate material or multiple layers of material. In yet another example, the external layer may include a hydrocolloid adhesive.

In some embodiments, the external layer may include a material selected from a hydrocolloid adhesive having pectin, gelatin, and sodium carboxymethyl cellulose (NaCMC). Exemplary embodiments include, but are not limited to, Stomahesive™, Durahesive™, Modified Stomahesive™, or Coloplasts Brava strips. Other materials that may be included in the external layer include silicone, acrylics, cyanoacrylate (such as Liquiband, for example), rubbers, foams, cellulose, polyurethanes, polyethylenes, polyvinyl chlorides, ethylenevinyl acetates, polypropylenes, polytetrafluorethylenes, and polyisobutylenes. The external layer may comprise Trilam (SH/DH) having a Stomahesive™ seal or a Durahesive™ seal, at least in some embodiments.

In some embodiments, the convex layer of any ostomy wafer disclosed herein may include a skin barrier. The skin barrier may include a ring formed from, or in the form of, a mold. The convex layer and/or the skin barrier may include an adhesive that is embodied as, or otherwise includes, a stoma adhesive. The stoma adhesive may provide a barrier or seal against effluent to ensure a single-directional flow through the opening of the convex layer (see the effluent flow arrows in <FIG> and <FIG>). In one embodiment, the skin barrier is a moldable adhesive that is breathable and/or moisture-absorbing. By way of non-limiting example, the skin barrier may be selected from Stomahesive™ Seal (ConvaTec), Brava Moldable adhesive Ring (Coloplast), Eakin Cohesive Seal (ConvaTec), Adapt Barrier Ring (Hollister), SecuPlast Mouldable Seal (Salts), and Siltac (Trio).

The skin barriers contemplated by the present disclosure are adapted to fill in and/or be received in cavities/folds in the intact skin around the stoma to protect the underlying skin from contact with bodily fluids. In some embodiments, the skin barriers may be made from pectin-based, hydrocolloid-type ingredients, mineral oils, plasticisers, tackifiers, and elastomers, with varying compositions.

In some embodiments, the convex layer of any ostomy wafer disclosed herein may be relatively cylindrical, funnel-shaped, and/or bowl-shaped, with a rim (e.g., the rims <NUM>, <NUM>, <NUM> shown in respective <FIG>, <FIG>, and <FIG>) that is in contact with the external layer. The profile of the convex layer may include both convex and concave forms, at least in some embodiments. Additionally, in some embodiments, the profile of the convex layer may be stepped or continuous, with increments of about <NUM> to about <NUM>, or about <NUM> to about <NUM> (see <FIG>).

The opening of the convex layer through which effluent flows is generally positioned at/near the base of the bowl, opposite the mouth/rim. It should be appreciated that the convex layer should have appropriate dimensions for positioning into, around, or against a flush or retracted stoma. In one example, with regards to a flush stoma, the opening of the convex layer may be sized to fit around internal tissue such that the convex exterior rim of the "bowl" contacts the peristomal skin around the internal tissue and minimally extends beyond the surface of the skin surrounding the stoma. In the example of a retracted stoma, the convex layer may have a relatively shallow bowl depth and be wide enough to leave little or no space between the peristomal skin and the exterior rim and/or sides of the convex layer.

In some embodiments, the depth of the convex layer bowl may be between about half of a centimeter and about ten centimeters. Additionally, in some embodiments, the depth of the bowl may be between about one centimeter and about <NUM> centimeters. In some embodiments still, the gross diameter of the wafer may be between about <NUM> and about <NUM>, about <NUM> and about <NUM>, or about <NUM> and about <NUM>. In some embodiments yet still, the height of the ostomy wafer may be about <NUM> to about <NUM>. Further, in some embodiments, the height of the ostomy wafer may be about <NUM> to about <NUM>. Finally, in some embodiments, the height of the ostomy wafer may be about <NUM> to about <NUM>.

In some embodiments, the aperture (e.g., the proximal opening <NUM>) of any ostomy wafer of the present disclosure may fit stomas ranging in average diameter from about <NUM> to about <NUM>. Additionally, in some embodiments, the ostomy wafer aperture may fit stomas ranging in average diameter from about <NUM> to about <NUM>. In some embodiments still, the ostomy wafer aperture may fit stomas ranging in average diameter from about <NUM> to about <NUM>. Further, in some embodiments, the width of the bowl may be between about two centimeters and about ten centimeters. It should be appreciated that the convex layer, as well as additional components of the ostomy wafers, may be manufactured by use of compression molds with heat treatment for adhesive molding.

In some embodiments, the convex layer of any ostomy wafer described herein may include a single layer. Additionally, in some embodiments, the convex layer may include a multilayer or multi-laminate material or multiple layers of material. In some embodiments still, the convex layer may include a hydrocolloid adhesive. In some embodiments yet still, the convex layer may include a material selected from Stomahesive™ seal.

The external layer and the convex layer of any ostomy wafer disclosed herein may completely or partially overlap, at least in some embodiments. In some cases, the external layer and the convex layer may have the same outer diameters. In other cases, the convex layer may have a greater outer diameter than that of the external layer. Additionally, in other cases, the external layer may have a greater outer diameter than that of the convex layer. In some embodiments, the external layer and the convex layer may have the same inner diameters. Additionally, in some embodiments, the convex layer may have a greater inner diameter than that of the external layer. In some embodiments still, the external layer may have a greater inner diameter than that of the convex layer.

The ostomy wafer may include an internal layer (e.g., the internal layer <NUM>, <NUM>) as indicated above. The internal layer may be positioned on the convex surface of the convex layer so that the internal layer contacts peristomal skin, as seen in <FIG>. The internal layer may include a moldable adhesive barrier, at least in some embodiments. Additionally, in some embodiments, a moldable adhesive barrier may include an adhesive designed as an ostomy accessory to aid adherence of a pouch/dressing to the skin around a stoma, thereby protecting the skin from effluent while conforming to the stoma and/or surrounding skin. The moldable adhesive barrier may have a putty-like or rubberlike consistency, at least in some embodiments. Furthermore, in some embodiments, the internal layer may include a material selected from Eakin Cohesive Seal (ConvaTec), Adapt Barrier Rings (Hollister), SecuPlast Mouldable Seal (Salts), and Siltac (Trio). The internal layer may include Stomahesive™ seal and/or Stomahesive™ paste, at least in some embodiments.

The ostomy wafer may include one or more additional layers, at least in some embodiments. In some embodiments, the one or more additional layers may include adhesive. In other embodiments, the one or more additional layers may not include adhesive. In some embodiments still, the one or more additional layers may include a material selected from adhesive, laminate, foam, gel, rubber, fabric, plastic, and combinations thereof. It should be appreciated that the one or more additional layers may contribute to the flexibility or moldable character of the ostomy wafer, at least in some embodiments.

In some embodiments, the stoma channel (e.g., the stoma channel <NUM>) of any ostomy wafer of the present disclosure may include at least one structure (e.g., any one or more of the features <NUM>, <NUM>, <NUM>) to enhance the seal established between the ostomy wafer and the stoma. It should be appreciated that the stoma channel structures contemplated herein are generally designed for use with a stoma and are capable of receiving, and/or coming into contact with, internal tissue that may be positioned in the stoma channel when the ostomy wafer is pushed against the stoma. In some embodiments, structures of the stoma channel disclosed herein may define spring-like or accordion-like structures. Additionally, in some embodiments, structures disclosed herein may allow the ostomy wafer to clamp onto a protruding stoma which may preclude use of, or minimize the need for use of, adhesive products.

In some embodiments, structures disclosed herein may prevent the ostomy wafer from dislodging from the stoma. Additionally, in some embodiments, structures disclosed herein may have a spring/rebound property that controls deformation with a predetermined or reference rebound force. It should be appreciated that the structures contemplated by the present disclosure may prevent, or substantially resist, a stoma from slipping out or pulling out of the stoma channel. Additionally, the structures disclosed herein may provide frictional interference between the stoma channel and the stoma, thereby facilitating securement of the ostomy wafer to the stoma.

Non-limiting examples of rigid or semi-rigid materials that may be incorporated into the stoma channel and/or the structures of the stoma channel disclosed herein include hydrocolloid adhesives (e.g., Stomahesive™, Durahesive™, Modified Stomahesive™, Stomahesive™ Seal, Duoderm, or Coloplasts Brava strips), silicone, acrylics, cyanoacrylate (e.g., Liquiband), rubbers, foams, cellulose, polyurethanes, polyethylenes, polyvinyl chlorides, ethylenevinyl acetates, polypropylenes, polytetrafluorethylenes, and polyisobutylenes. In some embodiments, the rigid or semi-rigid materials disclosed herein may be capable of limiting recovery of the adhesive to at least less than <NUM>.

In some embodiments, the stoma channels of the ostomy wafers disclosed herein may have different shapes. In one example, the stoma channel may be cylindrical. In another example, the stoma channel may be tapered. In some cases, the stoma channel may be tapered such that the stoma is inserted into the narrow end of the stoma channel. In other cases, the stoma channel may be tapered such that the stoma is inserted into the wide end of the stoma channel. Of course, it should be appreciated that in some embodiments, the stoma channel may not be provided with any structure or structural features other than the structure provided by the layers of the device.

In some embodiments, the stoma channel of the ostomy wafer and areas adjacent thereto may include moldable adhesive technologies. Those adhering features may reduce the number of steps typically required to seal an ostomy wafer to the skin and the stoma of a particular patient. For example, no scissors may be required to cut/tailor the stoma channel to the skin and the stoma of the patient, and there may be no need for additional pastes or adhesives to fill in the contours/structures of the ostomy wafer. Therefore, the ostomy wafers disclosed herein may offer easier and simpler application (and removal) for nurses and patients.

Any ostomy wafer of the present disclosure may include a flange or collar attached to the external layer. In some embodiments, the flange or collar may include additional adhesive for further securing the ostomy wafer to the ostomate and/or sealing the ostomy wafer to the ostomate to resist leakage. Common substances, devices, and/or methods may be employed to securely mate and seal a flange to a stoma, such as applying an adhesive substance (e.g., a paste) around the stoma, at the base of the ileum, and/or at the opening of the ostomy wafer/baseplate as filler for skin folds, uneven skin surfaces, and scars, for example. Other methods may involve using silicone gel to fill uneven skin surfaces, applying the gel directly around the stoma, and applying a wafer/baseplate directly onto the gel. According to such methods, the gel may cure underneath the wafer/baseplate during normal wear time. Non-limiting examples of pastes include ConvaTec's Stomahesive™ paste, Adapt Paste (Hollister), Brava Paste (Coloplast), Securiti-T Stoma Paste (Genairex), MicroHesive Stoma Paste (Cymed), and Osto Stoma Paste (Montreal Osto). Gels include, but are not limited to, Silicone Gel (Trio), and Osto Paste (Stoma-Tech). Additionally, in some embodiments, ingredients of the pastes/gels may include, but are not limited to, Sodium Carboxymethylcellulose, Thixcin, Gelatin, and Pectin.

The ostomy wafers of the present disclosure may include one or more coupling components (e.g., the coupling component <NUM>) to couple or adhere the ostomy wafer to an ostomy pouch. The coupling component(s) may be attached to any ostomy wafer disclosed herein. In some embodiments, the coupling component(s) may be included in the ostomy wafer or any layer thereof. In any case, it should be appreciated that the coupling component(s) are adapted to mechanically connect the ostomy wafer to the ostomy pouch, such as via adhesion by an adhesive layer applied to, coupled to, or otherwise incorporated into, the ostomy wafer and/or the ostomy pouch, or by interaction with one or more additional components. Of course, in other embodiments, the ostomy wafer may not include coupling component(s). In such embodiments, the ostomy wafer may contact the pouch directly or may contact a coupling feature of the pouch.

Ostomy devices of the present disclosure include an ostomy pouch and any one of the ostomy wafers disclosed herein. In some embodiments, the ostomy device may include one or more coupling components (e.g., the component <NUM> shown in <FIG>) configured for interaction with the ostomy pouch and/or the ostomy wafer to operatively couple the ostomy pouch and the ostomy wafer in use thereof.

In some embodiments, the coupling component(s) may include, be embodied as, or otherwise provide, a limited motion connection between the ostomy wafer and the ostomy pouch that permits relative displacement between substantially the entire ostomy wafer and the entrance aperture of the ostomy pouch. In such embodiments, the limited motion connection may guide relative displacement between the wafer and the pouch along a limited motion locus. More specifically, in some embodiments, the limited motion connection may guide movement of the wafer relative to the pouch (or vice versa) between an operative position and an access position. In the operative position, the ostomy wafer may be superposed around the entrance aperture of the ostomy pouch. Additionally, in the operative position, an adaptable region of the ostomy wafer may be shrouded by the ostomy pouch on the non-body-facing side and the wafer and pouch may be fixed to one another with a fixation coupling. In the access position, access is provided to the adaptable region from the non-body-facing side.

The coupling component(s) contemplated herein may guide alignment of, or movement between, the ostomy wafer and the ostomy pouch to the operative position, thereby facilitating use for some users, such as elderly, non-dexterous, or visually impaired persons, for example. At the same time, the limited motion connection may permit relative displacement of substantially the entire ostomy wafer with respect to the entrance aperture as discussed above, thereby facilitating conformance of the ostomy wafer to the size and/or shape of the user's stoma, at least in some embodiments. In some embodiments, the limited motion connection may include an articulating link that defines the limited motion locus.

In some embodiments, the ostomy device may be provided as a one-piece component to enhance access thereto and avoid complications such as wholly or partly immovable ostomy wafers, for example. The ostomy wafer may be permanently attached to the ostomy pouch directly or indirectly via the coupling component(s) (which may be permanently attached to the ostomy pouch). For the purposes of the present disclosure, the term "permanently attached" (or like phrases) means that the pieces may be attached with sufficient force that separation of the pieces results in breakage or damage complicating reattachment without additional equipment. Of course, it should be apparent from the teachings of the present disclosure that the ability to displace the ostomy wafer relative to the entrance aperture of the ostomy pouch may permit easier adaptation of the ostomy wafer (e.g., by forming, cutting, or shaping the stomal aperture, or by fitting and/or shaping a separate sealing member at the stomal aperture) to the ostomy pouch.

In some embodiments, the ostomy device may be a two-piece ostomy device. The components of the two-piece device may be aligned without significantly reducing access to the ostomy wafer to facilitate adaption of the ostomy wafer to the size and/or shape of stoma. Additionally, the components may be positioned relative to one another without detracting from the ability to position the body-fitment component on the body before fixing the other component in the operative position with respect to the body fitment component. In some embodiments, the limited motion connection and the coupling component(s) may include releasable coupling portions.

Further disclosed herein are methods of using the ostomy wafers and ostomy devices of the present disclosure. In some embodiments, the methods may include contacting the flush/retracted stoma with the ostomy wafer. Additionally, in some embodiments, the methods may include contacting the ostomy wafer with an ostomy pouch, cap, or plug that fills any one of the opening(s) of the ostomy wafer. In some embodiments still, the methods may include contacting the flush/retracted stoma or the ostomy wafer with an adhering substance that promotes adherence of the ostomy wafer to the ostomate. In some embodiments yet still, the methods may include contacting the flush/retracted stoma or the ostomy wafer with an additional adhesive besides the adhesive(s) that is a component of the ostomy wafer. Further, in some embodiments, the methods may include applying heat to mold the ostomy wafer or promote the adherent property of the additional adhesive. Further, in some embodiments still, the methods do not require a user to measure, size, fit, cut, or tear the device. Rather, in such embodiments, the user only need mold the device with their fingers to adapt to it to the stoma.

The kits of the present disclosure include any one of the ostomy wafers disclosed herein. In some embodiments, the kits may also include a kit component selected from an ostomy pouch, a viscous media, an adhesive seal, an adhesive barrier, an adhesive strip, an adhesive fabric, an adhesive paste, and combinations thereof.

The examples and embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the claims. It should be appreciated that various modifications or changes apparent to persons skilled in the art are within the spirit and purview of this application and scope of the appended claims.

An ostomate with a flush or recessed stoma ensures that his/her hands and the skin surrounding the stoma are clean, dry, and free from any solvent or oily substances before applying the ostomy wafer. A perforated chamber ostomy wafer (e.g., one of the wafers <NUM>, <NUM>, <NUM>) with an adhesive paste (e.g., viscous media <NUM>) is removed from packaging. One or more chambers (e.g., the chamber <NUM>) containing the adhesive paste are contained within a pliable, flexible, and perforated convex layer (e.g., the convex layers <NUM>, <NUM>, <NUM>).

A release liner is removed from the perforated chamber wafer (e.g., from a skin barrier thereof) and the opening (e.g., the proximal opening <NUM>) of the perforated chamber wafer is centered over the stoma. The perforated chamber wafer is then pressed into the stoma opening until an external layer of the wafer (e.g., the external layer <NUM>, <NUM>, <NUM>) is flush with external skin surrounding the stoma. As is the perforated chamber wafer is compressed into and around the stoma, the adhesive paste is extruded through the perforations (e.g., the perforations <NUM>) and out of the one or more chambers, thereby filling irregular contours and indentations of the skin to adhere the wafer to the ostomate and provide a secure seal.

To remove the perforated chamber wafer after use, the ostomy wafer is gently peeled from the body. Any residue can be removed from the skin by rolling and peeling, or by using Sensi-Care or Niltac Sting Free Adhesive Remover.

An ostomate ensures that his/her hands and the skin surrounding the stoma are clean, dry, and free from any solvent or oily substances before applying the ostomy wafer. A perforated chamber ostomy wafer (e.g., one of the wafers <NUM>, <NUM>, <NUM>) with one or more empty chambers (e.g., the chamber <NUM>) is removed from packaging. The one or more chambers are contained within a pliable, flexible, and perforated convex layer (e.g., the convex layers <NUM>, <NUM>, <NUM>). The convex layer is provided separately from an external layer (e.g., the external layer <NUM>, <NUM>, <NUM>). The convex layer includes a portion at its external rim for receiving and adhering/bonding to the external layer.

A release liner is removed from the convex layer of the wafer (e.g., from a skin barrier thereof) and the opening (e.g., the proximal opening <NUM>) of the convex layer is centered over the stoma. The convex layer is molded to the stoma without measurement or modification to the convex layer due to the moldable character of the convex layer. Once the convex layer is molded to the stoma, an adhesive paste (e.g., viscous media <NUM>) is added to one or more chambers of the convex layer. A second release liner is removed from the external layer and the external layer is applied to the convex layer to create a seal between the convex layer and the external layer and thereby confine the adhesive paste in the chamber(s) of the convex layer. It should be appreciated that the external layer and the convex layer both include adhesive on their skin-facing sides to adhere to the ostomate. Adhesive paste seeps through the perforations (e.g., the perforations <NUM>) and out of the one or more chambers, thereby filling irregular contours and indentations of the skin to adhere the wafer to the ostomate and provide a secure seal.

Claim 1:
An ostomy wafer comprising:
an external layer (<NUM>) including a stoma channel (<NUM>) to permit the passage of effluent therethrough, wherein the stoma channel extends in an axial direction;
an internal layer (<NUM>); and
a convex layer (<NUM>) coupled to the external layer such that the stoma channel extends therethrough, wherein the convex layer is formed to include a plurality of perforations (<NUM>) that are spaced in a radial direction from the stoma channel and at least one chamber (<NUM>) that is in fluid communication with the plurality of perforations and spaced from the stoma channel in the radial direction,
wherein the external layer at least partially closes off the at least one chamber to confine viscous media (<NUM>) that may be stored in the at least one chamber and distributed through the plurality of perforations to couple the ostomy wafer to a subject in use thereof, characterised in that: the internal layer at least partially covers an exterior of the convex layer that faces the subject and the internal layer includes a moldable adhesive material.