Patent ID: 12220343

DETAILED DESCRIPTION

While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiment illustrated.

Referring now to the accompanying figures, andFIGS.1-2in particular, a stoma template10is shown according to exemplary embodiments in a condition prior to use. As shown schematically inFIGS.1-2, stoma template10can be comprised of a body portion12having opposing inside and outside edges14,16and opposing first and second sides18,20. According to exemplary embodiments, shown schematically inFIGS.1-2, inside edge14can be arranged around and define an opening22extending through the template10between the first and second sides18,20and body portion12can radially extend outward from opening22. Opening can be circularly shaped and centrally located on template10as shown inFIGS.1-2, however it will be understood that opening can have other shapes and locations along template10without limitation. As shown inFIG.1, the outside edge16can have a greater circumference than the inside edge14.

According to exemplary embodiments shown schematically inFIGS.1-2, the first side18of body portion12can be comprised of a plurality of flexible segments24separated from one another by grooves26having perforations therein. As shown inFIGS.1-2, flexible segments24can extend between the inside and outside edges14,16of template10. Flexible segments24can fully surround opening22and be equally sized and shaped as shown inFIGS.1-2, although it will be understood that template10can have segments surrounding only around a portion of opening22or segments having multiple different shapes or sizes without departing from the novel scope of the subject invention. Flexible segments24can have substantially straight side edges and a substantially flat top surface which define the first surface of template10. The opposing second side20of template10can comprise a backing layer.

According to exemplary embodiments shown schematically inFIGS.1-2, flexible segments24can radiate outward from opening22such that the side edges of a segment diverge along their length as they extend toward the outside edge16of template10(by contrast, the side edges converging toward one another along their length as they extend inward from the outside edge16toward the inside edge14of template10). Thus, as will be understood, an arc formed between first points along opposing side edges equally distanced from the inside edge14will have a first length, and an arc formed between second points equally distanced from the inside edge14at a greater distance from the first points will have a second length greater than the first length. Accordingly, as shown inFIGS.1-2, flexible segments will widen as they extend toward outer edge16of template10.

As shown schematically inFIGS.1-2, grooves26can be comprised as channels defined between side edges of adjacent flexible segments24and can extend along the length of the side edges of adjacent segments between the inside and outside edges14,16of template10. Grooves can have a series of perforations through the body portion12which can facilitate separation of the flexible segments24upon being peeled back as described in additional detail below. It will be understood that the thickness and depth of grooves26(defined by the corresponding spacing and height of flexible segments24) can vary but be configured to permit template10to 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 segments24(between the first and second sides18,20of template10) 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 segments24having a thickness on the order between 0.1 and 0.5 inches and grooves26having a depth on the order of 0.09 and 0.49 inches.

According to exemplary embodiments, stoma template10can be comprised of a flexible or moldable material, such as for example a stomal skin barrier material. Additionally, the first side18of template10can be comprised of applied with a sticky, tacky or adhesive surface coating. Together with the grooves26, the flexible material and adhesive surface coating can enable portions of segments24adjacent opening22to 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 toFIG.3, a method100of fabricating a stoma template is representatively illustrated. As shown inFIG.3, stoma template can be provided101according to embodiments exemplified herein. In use a user can peel back102portions of one or more flexible segment24at the inside edge14of template10and fold104the peeled portion(s) back and over adjacent unpeeled portions of the respective one or more segments along the first side18of template10. 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 pressed106onto the unpeeled portion for being adhered thereto. It will be recognized that such steps can cause opening22to be enlarged and reshaped in the respective area. More particularly, the inside edge of the stoma template can be reconfigured108in specific areas32to customize opening22to correspond to a perimeter of a user's stoma.

For exemplification,FIG.4illustrates a reconfigured stoma template30in a condition of use whereby portions of one or more flexible segments24have been pealed back to enlarge and reshape opening22. As shown representatively inFIG.4, and as best seen when compared toFIG.1, opening22has been modified and made larger and to have an irregular shape formed by the inside edges32of certain flexible segments24being 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 template10, users can hold the template up to the stoma and peel back certain segments24until a custom size or shape is achieved whereby the template10fits around the stoma and/or the stoma fits through opening24. Embodiments presented herein can further provide for markings to be pre-applied along the first side18of template10at predetermined spacings around opening10so that a user can better gauge how far back to peel back certain foldable segments24and/or replicate a custom template. Users can also add markings themselves or trace the outline of the stoma along the first side18of template so that flexible panels24can be peeled and folded back the desired distance before being adhered to adjacent un-pealed portion(s).

Returning toFIG.3, once a template10has been customized to a user's preference or need, the template can be used to fabricate a custom skin barrier. More particularly, the template10can be placed over or oriented against110a skin barrier material and the barrier material can be cut112to correspond to the size and shape of the template including along the modified inside edge around the custom opening and along the outside edge16of template10. 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 template10can follow the lines of the reconfigured inside edge and the outside edge16.

According to exemplary embodiments presented herein, template10can 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 side18of template10. Since the first side18has 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 template10and can further be configured for being cut to conform with the modified opening of the template10.

In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.