Patent Description:
Ostomy pouches for the collection of body waste output from a stoma are well known and used by individuals who have had surgery such as a colostomy, ileostomy or urostomy. Ostomy pouches are generally attached to a user via an ostomy skin barrier, which is configured to seal against peristomal skin surfaces and protect the peristomal surfaces from exposure to stomal effluent. However, the shape and size of stomas can vary among patients and providing a single skin barrier which can effectively seal against the peristomal surfaces of differently sized or shaped stomas can be particularly challenging.

Devices such as template sheets, adhesive wafers and implantable skin grafts in various forms are generally known and used to fabricate a skin barrier to better corresponds to the shape and size of individual stomas. Such devices and solutions however are either invasive, difficult to use and/or not precise from the standpoint of generating a customized skin barrier that closely matches the specific size and contours of a particular user's stomal region.

<CIT> relates to a transparent film which can be used to produce a template for determining the shape of an individual stoma of an artificial outlet in colostomy, ileostomy and urostomy.

<CIT> discloses measurements of the topography of the stomal area of the patient being taken manually, by photographs taken at different angles, computerized touch probing, magnetic resonance imaging, computerized axial tomography, laser scanning or by casting. Information relating to the measurements is recorded on a card, a template or electronically. The recorded information is digitized and stored in a database, along with information concerning patent history and preferences. The electronic information is utilized to select the physical attributes of the wafer and pouch which best suit the needs of the user. The appropriate tools are automatically selected, adjusted and guided to fabricate customized wafers and pouches by computerized fabrication equipment. Parameters which can be varied include the size, shape and location of the stoma receiving opening, the wafer outline and surface contour, the adhesive type, the pouch size and shape, the tail location, the tap type and location, the flange style and the filter location, as well as the accessories which are required.

<CIT> discloses the preamble of claim <NUM> and in particular discloses a method for making a customized ostomy appliance including an adhesive wafer having the steps of measuring the outer periphery of the stoma of the patient, recording the information relating to the measurements of the stoma area, transforming the recorded information into electronic form, and utilizing the electronic information to select physical attributes of the ostomy device and have physical attributes selected in accordance with the measurement information transferred to the ostomy appliance. According to the method, the measurement information is utilized for printing a customized cutting guide pattern on a material for adhering to the adhesive wafer, offering a simple and efficient method of customizing ostomy appliances.

<CIT> discloses a display arrangement for organizing and presenting supplies and implements needed for ostomy care has at least one display surface for the supplies and implements, the display surface having alphamerically sequenced indicia disposed thereon. The indicia include at least one indicator for at least one skin preparation product, at least one indicator for stoma measurement, at least one indicator for at least one wafer cutting implement, at least one indicator for a wafer, at least one indicator for at least one adhesive product; and at least one indicator for at a pouch.

<CIT> provides a method for forming an opening of a shape precisely matching the stoma of a patient in a base plate of a stoma device. A method of forming an opening in a base plate of a stoma device according to the present invention comprises a step of printing on a label a filled-in-part of the same shape as a hole of a shape formed on a template sheet and matching the stoma of a patient, a step of sticking the label on which the filled-in-part has been printed on to a base plate, and a step of cutting the base plate along the contours of the filled-in-part of the label stuck to the base plate.

Accordingly, as will be recognized from the subject disclosure, there is a critical need in the art for a stoma template that is economical, simple to use and capable of fabricating a precisely sized and shaped skin barrier that closely seals around the stoma of different users. There is a further need in the art to provide such stoma template for multiple use.

Embodiments presented herein are directed to a stoma template comprising a body portion having opposing inside and outside edges and opposing first and second sides. The inside edge of the stoma template can define an opening extending through the body portion between the first and second sides. The first side can have a plurality of flexible segments extending between the inside and outside edges. The plurality of flexible segments can be separated from one another by grooves and have a sticky surface along the first side of the body portion. At least a portion of a flexible segment of the plurality of flexible segments can be peelable away from the opening to form a peeled portion. The peeled portion can be foldable over a respective unpeeled portion of the flexible segment and be adherable to the sticky surface. The inside edge of the body portion can be pulled back by the peeled portion and the opening being expanded.

According to exemplary embodiments, the grooves along the first side of the body portion can comprise a series of perforations along their length. The plurality of flexible segments can have substantially straight opposing side edges that can extend from the inside edge to the outside edge of the body portion. The opposing side edges of adjacent flexible segments can define opposing side edges of one of the grooves. The plurality of flexible segments can be comprised of skin barrier material. The plurality of flexible segments can encircle the opening and radiate outward therefrom. The plurality of flexible segments can widen as they extend toward the outside edge of the body portion. The stoma template can further comprise a film to cover the first side of the body portion. The film can be adherable to the sticky surface. The body portion can be toroid-shaped wherein the opening can be centrally located.

Embodiments presented herein are further directed to methods of fabricating an ostomy skin barrier. According to such methods, a stoma template can be provided having a plurality of flexible segments along a first side between opposing inside and outside edges. The plurality of flexible segments can have a sticky surface and be separated from one another by grooves having perforations therein. A portion of at least one flexible segment of the plurality of flexible segments can be peeled outward and away from a central opening in the stoma template to form a peeled portion. The peeled portion can be folded over a respective unpeeled portion of the at least one flexible segment. The peeled portion can be pressed to the sticky surface of the unpeeled portion to cause the peeled portion and a portion of the unpeeled portion to stick together. The inside edge of the stoma template can be reconfigured to customize the opening to correspond to a perimeter of a stoma. The template can be placed alongside an ostomy skin barrier material. The skin barrier material can be cut to correspond to the stoma template. The cutting can form opposing inside and outside edges of the ostomy skin barrier whereby the opposing inside and outside edges of the ostomy skin barrier respectively correspond to the reconfigured inside edge and the outside edge of the stoma template.

According to exemplary embodiments, methods presented herein can further comprise placement of the stoma template alongside the stoma to identify which of the plurality of flexible segments to peel back and how much of the portion of at least one flexible segment should be peeled. An outline of the stoma template can be onto the ostomy skin barrier whereby the tracing can follow the reconfigured inside edge and the outside edge of the stoma template. A film can be cut to correspond to the stoma template. The film can be adhered to the first side of the stoma template along the sticky surface. The cutting can form opposing inside and outside edges of the film which can respectively correspond to the reconfigured inside edge and the outside edge of the stoma template.

Other objects, advantages and features of the present disclosure will be understood and appreciated by persons of ordinary skill in the art from consideration of the following specification taken in conjunction with the accompanying drawings.

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.

Referring now to the accompanying figures, and <FIG> in particular, a stoma template <NUM> is shown according to exemplary embodiments in a condition prior to use. As shown schematically in <FIG>, stoma template <NUM> can be comprised of a body portion <NUM> having opposing inside and outside edges <NUM>, <NUM> and opposing first and second sides <NUM>, <NUM>. According to exemplary embodiments, shown schematically in <FIG>, inside edge <NUM> can be arranged around and define an opening <NUM> extending through the template <NUM> between the first and second sides <NUM>, <NUM> and body portion <NUM> can radially extend outward from opening <NUM>. Opening can be circularly shaped and centrally located on template <NUM> as shown in <FIG>, however it will be understood that opening can have other shapes and locations along template <NUM> without limitation. As shown in <FIG>, the outside edge <NUM> can have a greater circumference than the inside edge <NUM>.

According to exemplary embodiments shown schematically in <FIG>, the first side <NUM> of body portion <NUM> can be comprised of a plurality of flexible segments <NUM> separated from one another by grooves <NUM> having perforations therein. As shown in <FIG>, flexible segments <NUM> can extend between the inside and outside edges <NUM>, <NUM> of template <NUM>. Flexible segments <NUM> can fully surround opening <NUM> and be equally sized and shaped as shown in <FIG>, although it will be understood that template <NUM> can have segments surrounding only around a portion of opening <NUM> or segments having multiple different shapes or sizes without departing from the novel scope of the subject invention. Flexible segments <NUM> can have substantially straight side edges and a substantially flat top surface which define the first surface of template <NUM>. The opposing second side <NUM> of template <NUM> can comprise a backing layer.

According to exemplary embodiments shown schematically in <FIG>, flexible segments <NUM> can radiate outward from opening <NUM> such that the side edges of a segment diverge along their length as they extend toward the outside edge <NUM> of template <NUM> (by contrast, the side edges converging toward one another along their length as they extend inward from the outside edge <NUM> toward the inside edge <NUM> of template <NUM>). Thus, as will be understood, an arc formed between first points along opposing side edges equally distanced from the inside edge <NUM> will have a first length, and an arc formed between second points equally distanced from the inside edge <NUM> at a greater distance from the first points will have a second length greater than the first length. Accordingly, as shown in <FIG>, flexible segments will widen as they extend toward outer edge <NUM> of template <NUM>.

As shown schematically in <FIG>, grooves <NUM> can be comprised as channels defined between side edges of adjacent flexible segments <NUM> and can extend along the length of the side edges of adjacent segments between the inside and outside edges <NUM>, <NUM> of template <NUM>. Grooves can have a series of perforations through the body portion <NUM> which can facilitate separation of the flexible segments <NUM> upon being peeled back as described in additional detail below. It will be understood that the thickness and depth of grooves <NUM> (defined by the corresponding spacing and height of flexible segments <NUM>) can vary but be configured to permit template <NUM> to have sufficient firmness and structure to avoid unintended tears or separation while also being capable of manipulation as explained in greater detail herein. Concurrently, it will be understood that the thickness of flexible segments <NUM> (between the first and second sides <NUM>, <NUM> of template <NUM>) can vary but be configured to provide sufficient rigidness so as not to unintentionally or uncontrollably fold while also being capable of having sufficient pliability to intended peeling and folding as explained in greater detail herein. Thus, by way of exemplification only, representative embodiments presented herein can have flexible segments <NUM> having a thickness on the order between <NUM> and <NUM> (<NUM> and <NUM> inches) and gooves <NUM> having a depth on the order of <NUM> and <NUM> (<NUM> and <NUM> inches).

According to exemplary embodiments, stoma template <NUM> can be comprised of a flexible or moldable material, such as for example a stomal skin barrier material. Additionally, the first side <NUM> of template <NUM> can be comprised of applied with a sticky, tacky or adhesive surface coating. Together with the grooves <NUM>, the flexible material and adhesive surface coating can enable portions of segments <NUM> adjacent opening <NUM> to be to be peeled back and folded over itself to create a customized template for use in making a custom-fitted skin barrier.

More particularly, and with reference to <FIG>, a method <NUM> of fabricating a stoma template is representatively illustrated. As shown in <FIG>, stoma template can be provided <NUM> according to embodiments exemplified herein. In use a user can peel back <NUM> portions of one or more flexible segment <NUM> at the inside edge <NUM> of template <NUM> and fold <NUM> the peeled portion(s) back and over adjacent unpeeled portions of the respective one or more segments along the first side <NUM> of template <NUM>. It will be recognized that upon peeling and folding a flexible segment over itself, that the sticky or tacky surface of the peeled and unpeeled portions can be oriented to face each other. According to exemplary embodiments, the peeled portion can then be pressed <NUM> onto the unpeeled portion for being adhered thereto. It will be recognized that such steps can cause opening <NUM> to be enlarged and reshaped in the respective area. More particularly, the inside edge of the stoma template can be reconfigured <NUM> in specific areas <NUM> to customize opening <NUM> to correspond to a perimeter of a user's stoma.

For exemplification, <FIG> illustrates a reconfigured stoma template <NUM> in a condition of use whereby portions of one or more flexible segments <NUM> have been pealed back to enlarge and reshape opening <NUM>. As shown representatively in <FIG>, and as best seen when compared to <FIG>, opening <NUM> has been modified and made larger and to have an irregular shape formed by the inside edges <NUM> of certain flexible segments <NUM> being peeled back. In view of the fact that stomas can vary in shape and size between different users, it will be recognized that embodiments presented herein can be particularly useful to create a customized template that can be particularly suited for each individual user.

In customizing the template <NUM>, users can hold the template up to the stoma and peel back certain segments <NUM> until a custom size or shape is achieved whereby the template <NUM> fits around the stoma and/or the stoma fits through opening <NUM>. Embodiments presented herein can further provide for markings to be pre-applied along the first side <NUM> of template <NUM> at predetermined spacings around opening <NUM> so that a user can better gauge how far back to peel back certain foldable segments <NUM> and/or replicate a custom template. Users can also add markings themselves or trace the outline of the stoma along the first side <NUM> of template so that flexible panels <NUM> can be peeled and folded back the desired distance before being adhered to adjacent un-pealed portion(s).

Returning to <FIG>, once a template <NUM> has been customized to a user's preference or need, the template can be used to fabricate a custom skin barrier. More particularly, the template <NUM> can be placed over or oriented against <NUM> a skin barrier material and the barrier material can be cut <NUM> to correspond to the size and shape of the template including along the modified inside edge around the custom opening and along the outside edge <NUM> of template <NUM>. According to exemplary embodiments, an outline of the template can also be traced onto the barrier material with a drawing instrument before cutting to ensure that the shape and size are in accordance with a user's preference before cutting into the barrier material. It will be recognized that the cutting or tracing of the template <NUM> can follow the lines of the reconfigured inside edge and the outside edge <NUM>.

According to exemplary embodiments presented herein, template <NUM> can be intended for single use or multiple uses. Where intended for multiple use, embodiments presented herein can additionally include a cover layer such as a film which can be placed over or applied to the first side <NUM> of template <NUM>. Since the first side <NUM> has a sticky or tacky coating, the film can adhere thereto and cover the sticky side so that the template won't stick to other articles or trap debris. Cover layer can also include an adhesive or sticky surface to facilitate securing to template <NUM> and can further be configured for being cut to conform with the modified opening of the template <NUM>.

Claim 1:
A stoma template (<NUM>) comprising:
a body portion (<NUM>) having opposing inside and outside edges (<NUM>, <NUM>) and opposing first and second sides (<NUM>, <NUM>);
wherein the inside edge (<NUM>) defines an opening (<NUM>) extending through the body portion between the first and second sides;
characterised in that the first side (<NUM>) has a plurality of flexible segments (<NUM>) extending between the inside and outside edges, the plurality of flexible segments being separated from one another by grooves (<NUM>) and having a sticky surface along the first side of the body portion, and
wherein at least a portion of a flexible segment of the plurality of flexible segments (<NUM>) is peelable away from the opening (<NUM>) to form a peeled portion, the peeled portion being foldable over a respective unpeeled portion of the flexible segment and being adherable to the sticky surface, the inside edge (<NUM>) of the body portion being pulled back by the peeled portion and the opening (<NUM>) being expanded.