DK202270635A1 - A demonstration tool and a kit of parts for an ostomy appliance user - Google Patents

Abstract

A demonstration tool for demonstrating physical conditions of an ostomy to a user of ostomy appliances including an artificial ostomy with a body with a peripheral external surface and two end surfaces, wherein the body includes portions of different nuances.

Description

DK 2022 70635 A1 1

A DEMONSTRATION TOOL AND A KIT OF PARTS

FOR AN OSTOMY APPLIANCE USER

Background

Stomal output contains body fluids and visceral contents that are aggressive to both the skin of a user and to ostomy appliances. The output can have a detrimental effect on the efficiency and integrity of the adhesive materials that are applied to attach the ostomy appliance to the user's skin surface. Moreover, all stomas are different and may require individual adaptations of an ostomy appliance to the — individual stoma to provide an optimized performance of the ostomy appliance. For ostomists, safe, reliable, and efficient ostomy appliances are highly desirable. The reliability of the ostomy appliance has been shown to be closely connected the overall quality of life of ostomists. Numerous attempts have been made to improve ostomy appliances, including prolonging their wear time, but the provision of sufficient efficiency to achieve a satisfactory long wear time of ostomy appliances has historically been an unmet need. Further, some attempts have been made to provide solutions which can aid ostomists in obtaining a better fit of the appliance to their individual needs.

CN209312317U discloses a stoma teaching model, including a torso model — including different stoma type models and one or more typical ostomist conditions, such as a hernia.

US2014/0052048 discloses an ostomy learning device which includes a body attachment device and an artificial stoma.

DE202011002969U1 discloses another ostomy model for education purposes.

Ostomists and health care professionals alike would welcome improvements in the field of ostomy appliances to provide better fit of the appliances and provide longer wear times of the appliances.

Summary

The present disclosure provides aspects of a demonstration tool for demonstrating to a user of ostomy appliances different conditions of an ostomy. In some cases, the different conditions of the ostomy may influence the requirements for,

DK 2022 70635 A1 2 and the performance characteristics of, ostomy appliances. It is helpful to be able to illustrate stoma conditions that can influence such requirements and performance characteristics. In embodiments, the demonstration tool includes means for demonstrating to a user of ostomy appliances an impact of mucin-contamination of a base plate during application of the base plate around the ostomy.

Brief Description of the Drawings

The accompanying drawings are included to provide a further understanding of implementations/embodiments and are incorporated in and constitute a part of this specification. The figures illustrate implementations and together with the description serve to explain principles of implementations. Other implementations and many of the intended advantages of implementations will be readily appreciated as they become better understood by reference to the following detailed description. Like reference numerals designate corresponding similar parts.

Various exemplary implementations and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the implementations. — They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated implementation needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular implementation is not necessarily limited to that implementation and may be practiced in any other implementations even if not so illustrated, or if not so explicitly described.

Figure 1A is a schematic, cross-sectional, side view of one embodiment of a generally cylindrical body of an artificial ostomy of a demonstration model according to the disclosure.

Figure 1B is a schematic, perspective view of one embodiment of a generally cylindrical body of an artificial ostomy.

DK 2022 70635 A1 3

Fig. 1C is a schematic illustration of one embodiment of a kit of parts of the present disclosure including a first demonstration tool and a second demonstration tool attached to each other.

Fig. 1D is a schematic, perspective illustration of a body of an artificial ostomy of one embodiment of a demonstration tool of the present disclosure.

Figures 2A-C is a series of illustrations demonstrating, in schematic, cross- sectional, side views, the process of applying a base plate around a generally cylindrical body of an artificial ostomy of the demonstration tool.

Figures 3A-D is a series of illustrations demonstrating, in schematic top and cross-sectional side views, the process of squeezing a drop of liquid between two glass plates, which illustrates the mechanism behind the problem of mucin-contamination of an adhesive base plate.

Figures 4A-C are schematic drawings showing a base plate being applied around a user's stoma S and onto a peristomal skin surface P and being compromised — by mucin in the application process.

Figure 5 is a schematic, non-exhaustive illustration of five exemplary different stoma profiles which can be resembled by a body of an artificial ostomy of a demonstration tool according to the present disclosure.

Figure 6 is a schematic view of one embodiment of kit of parts according to — the present disclosure, including two demonstration tools, a base plate and a collecting bag of an ostomy appliance.

Detailed Description

In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific implementations/embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of implementations can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other implementations may be utilized, and structural or logical changes may be made without departing from the

DK 2022 70635 A1 4 scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense.

It is to be understood that the features of the various exemplary implementations/embodiments described herein may be combined with each other, — unless specifically noted otherwise.

Throughout this disclosure, the words “stoma” and “ostomy” are used to denote a surgically created opening bypassing the intestines or urinary tract system of a person. The words may be used interchangeably, and no differentiated meaning is intended. The same applies for any words or phrases derived from these, e.g. “stomal”, “ostomies” etc. Also, the solid and liquid wastes emanating from the stoma may be referred to as both stomal “effluents”, “output,” “waste(s),” “fluids” and other interchangeably. A person or subject having undergone ostomy surgery may be referred to as “ostomist” or “ostomate” — moreover, also as “patient” or “user”.

However, the phrase “user” can also relate or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse or others. Addressing ‘stoma’ herein refers at least to ostomy, ileostomy and urostomy as the problem of contamination of the adhesive surface of a base plate can be caused by stomal effluents in any of these conditions.

In the following, whenever referring to proximal side or surface of a device or part of an appliance (or component), the referral is to the skin-facing side or surface, when the ostomy appliance is worn by a user. Likewise, whenever referring to the distal side or surface of an appliance or part of an appliance, the referral is to the side or surface facing away from the skin, when the ostomy appliance is worn by a user. In other words, the proximal side or surface is the side or surface of something being closest to the user, when the appliance is fitted on a user and the distal side or surface is the opposite side surface - the side or surface of something farthest away from the user in use.

The “axial” direction is defined as the direction of the stoma when the appliance is worn by a user. Thus, the axial direction is generally perpendicular to the stomach skin or abdominal skin surface of the user.

The radial direction is defined as transverse to the axial direction that is transversely to the direction of the stoma. In some sentences, the words “inner” and “outer” may be used. These qualifiers should generally be perceived with reference to

DK 2022 70635 A1 the radial direction, such that a reference to an “outer” element means that the element is farther away from a centre portion of a thing, e.g. a base plate for an ostomy appliance than an element referenced as “inner”. In addition, “innermost” should be interpreted as the portion of a thing or component forming a centre of the 5 component and/or being adjacent to the centre of the component or alternatively to an inner (e.g. peripheral) edge thereof. In analogy, “outermost” should be interpreted as a portion of a component forming an outer (e.g. peripheral) edge or outer contour of a component and/or being adjacent to that outer edge or outer contour.

In this specification, end means endmost and end portion means that segment that is adjacent to and extends from the end.

The use of phrases such as (but not limited to) “substantially” and “approximately” as qualifiers of certain features or effects in this disclosure, is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features or effects in this disclosure is intended to mean - for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and - for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect, but that exceptionally some outcomes may not provide the effect.

The phrase “adjacent”, such as in the wording “adjacent the surface”, should be interpreted as being “close to and/or in contact with, or temporarily brought into contact with, but not attached to the surface.”

During application of a base plate to the peristomal skin around a stoma, great care must be taken to properly place the base plate around the stoma and further not to contaminate the adhesive material of the base plate with stomal effluents.

However, both proper placing and avoiding contamination of the adhesive material of the base plate with stomal effluents have proven very difficult for users. A stoma- receiving opening in the base plate is generally provided at manufacture or cut by the user to fit closely around the stoma thus leaving only little extra room or space around the stoma during application of the base plate. The risks of mis-adapting the stoma- receiving opening and of touching the stoma, and/or touching or contacting stomal effluents exuded from the stoma with the edge of the stoma-receiving opening of the

DK 2022 70635 A1 6 base plate, or other portion of the adhesive material during application of a base plate, are therefore significant.

For example, it has been found that even a small amount or droplet of stomal effluent on the adhesive material can quickly spread or disperse to contaminate a substantial area of the adhesive material, a problem often worsened as the base plate is subsequently subjected to finger pressure to adhere the adhesive material against the peristomal skin surrounding the stoma (the adhesive material often being of the pressure-sensitive kind). Moreover, all stomas have individual sizes and very different shapes and contours, also adding to making the task of adapting the base plate and the stoma-receiving opening to the individual stoma and of applying it without touching and thus avoiding contamination of the adhesive surface of the base plate difficult to ensure.

A further problem is that it is often hard for a user to see what he or she is doing when applying a base plate to their belly, because the stoma is often located on a lower or downwardly facing portion of the stomach skin, at least when the user is in a standing position.

A stoma-receiving opening of a base plate is often only slightly larger than the stoma itself, and therefore both improper location of the base plate and contamination of the adhesive material on the proximal surface of the base plate — before bonding to the skin surface are prone to happen during application of the base plate of the ostomy appliance. Typically, a user is instructed to leave as little room between the stoma and the (e.g. customized) stoma-receiving opening to prevent stomal effluents from entering between the adhesive and the skin surface, to avoid damage to the peristomal skin from moisture (skin maceration) and/or aggressive constituents of the stomal effluents, e.g., enzymes produced in the intestines.

However, when following that instruction, it is often very difficult to avoid contact between the stoma and/or the peristomal skin surface and the edge of the stoma- receiving opening during application of the base plate.

Experience has shown that when stomal waste and effluents, including urine — and/or faeces and other constituents, come into contact with the adhesive material of a base plate, the adhesive properties can decrease temporarily and/or permanently.

This will decrease the strength of the adhesive bond between the base plate and the skin and can also lead to creation of chambers or canals in the adhesive material

DK 2022 70635 A1 7 and/or between the adhesive material and the skin. Stomal effluents can thus easily pass underneath the adhesive in the peristomal area, which can lead to further reduced adhesion.

Even small amounts of stomal effluents on the adhesive material may cause this reduction in tack to occur and pave the way for premature failure of the adhesive material already during application of a fresh base plate. Such failure can lead to leakage, which is regularly cited as the biggest concern for users of ostomy devices.

Avoiding contamination of the adhesive material during application of a base plate and the task of properly locating the base plate, to cater for the characteristics — and physical condition of the individual stoma, are therefore key problems in connection with the application of base plates for ostomy appliances.

The inventors have observed from tests and studies that contamination of the adhesive material frequently happens because the inner peripheral edge of the stoma- receiving opening of a base plate (which edge is a very short distance from the stoma — surface) is highly prone to contact or touch and “scrape off” stomal effluents from the stoma surface when the user shifts or moves the base plate towards the peristomal skin surface for bonding thereto.

Importantly, it has surprisingly been observed by the inventors that, in many cases, an almost invisible layer of an aqueous liquid or gel-like substance containing — mucin is present on the stoma and/or at the root of the stoma and/or on the peristomal skin surface, even in cases where the stoma and peristomal skin surface have been thoroughly wiped off by the user and both appear “clean”. This almost invisible layer can include mucus and mucins coming from the mucous membrane of the stoma and out of the stoma from the intestinal walls. Mucus is a slippery aqueous secretion produced by, and covering, mucous membranes. Mucins are a family of high molecular weight, heavily glycosylated proteins (glycoconjugates) produced by epithelial tissues in most animals, such as in the intestinal walls of humans. The aqueous gel on the surface of the stoma may typically contain mucins in an amount of 1-10 %. The exact composition and amount will vary widely between different ostomists.

The issue of contamination of the adhesive material with mucin is visualized in

Figures 3A-D. In figures 3A (top view) and 3B (side view), a droplet of coloured liquid (illustrating stomal effluent and coloured to enhance visibility) is placed on a glass

DK 2022 70635 A1 8 plate (illustrating the skin of a user). In Figures 3C (top view) and 3D (side view), a second glass plate (illustrating a base plate for an ostomy appliance) is placed over the droplet, and the droplet is thereby squeezed and spread out over a larger area. The contour and extent of the spread-out droplet is drawn up to visualize the area now being contaminated with liquid. As can be seen, the droplet of liquid is now squeezed out to cover a substantial portion of the glass plate. Studies done by the inventors have shown that this same mechanism applies on the adhesive surface of a base plate having been subjected to mucin when it is applied to the peristomal skin surface around a stoma. Even if the mucin is only contaminating a zone near the edge of the stomal opening of the base plate, the example and experience shows that the mucin can quickly spread from the inner zone to a larger surface portion of the base plate's adhesive.

Moreover, it was found by the inventors that when mucin comes into contact with the adhesive material of an ostomy appliance base plate, the adhesive material — rapidly loses it adhesive capability and tack. This means that the adhesive cannot properly adhere to the peristomal skin surface in the areas contaminated by mucin.

This then in turn means that “canals” or “paths” can be created between the (non- adhered) adhesive material and the peristomal skin surface in the contaminated areas, in which canals or paths of urine or faeces released from the stoma can travel. This in — turn provides the possibility for the urine or faeces to harm and/or degrade the adhesive material in or along the canals or paths, thereby leading to further undermining of adhesion and tack, and thus to a vicious circle of adhesive breakdown and risk of adhesive failure and leakage.

A stoma can be described as a living, mucin-producing (see above) organ.

Stomas come in all kinds of different sizes and shapes and can move autonomously (cf. Figure 5). These and other factors make the act of applying a stoma appliance in the best way (i.e., the most appropriate way to ensure a long period of wear) challenging for many users. However, it is believed that at least some of the less-than- optimal examples of applications of base plates of ostomy appliances to peristomal — skin can be avoided or reduced by providing a demonstration tool allowing for training purposes according to the present disclosure.

An important issue that should preferably be taken into consideration when seeking to optimize the application of an ostomy appliance onto the skin of a user is

DK 2022 70635 A1 9 the condition or state of the stoma itself and/or the condition of its surroundings, such as the peristomal skin surface. For some ostomists, the tissue of a surgically created stoma can suffer from bad or insufficient blood flow. This may lead to various problems. Particularly, in the event of an insufficient level of blood flowing to the stoma tissue, one problem can be the formation of necrotic (dead or dying) stoma tissue. In the event necrotic stoma tissue is formed this will often show by the colour of the tissue of the stoma turning dark or blackish in nuance or appearance. Conversely, a sound or healthy stoma will appear lighter, with generally light red nuances, particularly in comparison to a stoma exhibiting necrotic tissue. Another problem seen in connection with compromised blood flow in or around stoma tissue arises in cases where the blood has difficulty flowing away from the stoma tissue. In such cases, the stoma tissue can be forced to hold or contain an abnormally high amount or level of blood within it which causes the tissue to swell and enlarge. Thus, difficulty with leading the blood flow away from the stoma tissue can express itself as the stoma — becoming enlarged because of blood being accumulated there.

In an education setting where users and/or HCPs are to receive training in the often complex tasks of providing optimal stoma care, particularly including optimal adaptation and location of the base plate around the stoma, it is further advantageous to be able to illustrate to users or HCP-trainees the various problems which can arise in connection with bad or insufficient blood flow to and from the stoma tissue, e.g. leading to necrotic tissue and/or to enlarged or “swollen” stomas.

Thus, in embodiments, the present disclosure relates to a demonstration tool for demonstrating physical conditions of an ostomy to a user of ostomy appliances comprising an artificial ostomy comprising a body having a peripheral external surface, and a first end surface, and a second end surface, wherein at least a first portion of the body has a first light nuance and a second portion of the body has a second, relatively darker nuance. The peripheral external surface is generally visible to the surroundings.

In embodiments, the body of the artificial ostomy is generally cylindrical.

In embodiments, the body of the artificial stoma comprises both a peripheral external surface and an internal surface (the internal surface not immediately visible to the surroundings). In embodiments, the peripheral external surface, the internal surface, and the first end surface, and the second end surface of the artificial ostomy combine to form the generally cylindrical body.

DK 2022 70635 A1 10

In embodiments, the first portion of the body of the artificial ostomy having a first light nuance has a light colour and the second portion of the body having a relatively darker nuance has a dark colour. In embodiments, the first lighter nuance may be a light grey colour and the second darker nuance may be black. In embodiments, the first lighter nuance is a light red colour and the second nuance of the second portion is a dark red colour. In embodiments, the first light nuance of the first portion of the body and the second, relatively darker nuance of the second portion of the body are provided as various nuances of red, particularly light red, and brown or black, respectively.

A color may be defined in many ways. Two of the most recognized color systems are the CMYK color model and the CIE L*a*b* system. The color of the body of the artificial ostomy of the demonstration model of the present disclosure can be determined by both methods.

In the CMYK color model, the color may be determined by visual comparison — with color standards that are defined by the CMYK color model. The CMYK color model (process color, four color) is a subtractive color model, used in color printing, and is also used to describe the printing process itself. CMYK refers to the four inks used in some color printing: cyan, magenta, yellow, and key (black). The ”K" in CMYK stands for key since in four-color printing cyan, magenta, and yellow printing plates — are carefully keyed or aligned with the key of the black key plate.

In the CIE L*a*b* system, the color can be determined using a spectrophotometer of the type Sphere d/82 Spectrophotometer for color measurements, type SP64 Series, Manufacturer: X-Rite.

L% Lightness/Darkness (Value: White is 100 and black is O. og | TET a*: Red / Green coordinate Positive value = Red, negative value

TE ee b*: Yellow / Blue coordinate Positive value = Yellow, negative

Jee color.

DK 2022 70635 A1 11

Standard tolerance: CMC21: L*=2, he= Variable ellipse, C=1, Cf=1(Commercial

The person skilled in the art will be able to select appropriate values for the parameters using either one of the two systems for determining colour described above to find and implement suitable choices for the light and relatively darker nuances of the portions of the body of the artificial ostomy as explained in this application.

In embodiments, the first portion of the body corresponds to the peripheral external surface of the body and has the first light nuance. In embodiments, the second portion of the body corresponds to the internal surface of the body and has — the second, relatively darker nuance.

In embodiments, the internal surface of the body of the artificial ostomy includes a first zone adjacent the first end surface of the body and a second zone being closer to the second end surface of the body than the first zone. In embodiments, the first zone of the internal surface has a light red colour and the — second zone of the internal surface has a dark red colour. In embodiments, the light red colour of the first zone is identical to the light colour of the first portion of the body of the artificial ostomy. In embodiments, the first zone of the internal surface has a light red colour and the second zone of the internal surface has a black colour. A light red colour of the body of the artificial ostomy can be understood as providing an indication of healthy stoma tissue (because in a real-life stoma, a light red colour of a stoma is an indication that the stoma tissue is healthy with adequate and unhindered supply/flow of blood to the stoma).

Providing an artificial ostomy according to the various embodiments of the disclosed invention comprising a body having a first portion having a first light nuance and a second portion having a relatively darker nuance inter alia allows for the illustration of situations wherein an ostomy has become, or is beginning to become, necrotic, due to insufficient or impaired flow of blood to the stoma tissue. Particularly, the artificial ostomy can advantageously be configured such that the second, relatively darker nuance corresponds to a resemblance of necrotic stomal tissue and is made — visible only when the user or HCP using the demonstration tool manipulates the body of the artificial ostomy with one or more fingers (or a suitable tool). For example, the

DK 2022 70635 A1 12 demonstration tool can be configured to allow inspection of the second portion with the relatively darker nuance only if the user or HCP manipulates an internal surface of the body with a finger. Such a configuration of the artificial ostomy can reflect the appearance of a real-life stoma in situations where the stoma suffers from the formation of necrotic tissue. The described procedure wherein a finger is used to manipulate the internal surface of the body of the artificial ostomy reflects a possible real-life approach for a user or HCP to examine if a stoma is healthy or has begun to develop necrotic tissue. One way of determining the presence of necrotic tissue in a stoma is to use one or more fingers to perform a digital examination of the stoma, e.g. including putting a finger into the stoma and manipulate it to “open” or make visible “the inside tissue” or internal surface of the tissue of the stoma. An HCP may also be able to detect certain conditions associated with necrotic stomas by digitally examining the inside of the stoma. This could be the presence of a hernia or beginning hernia in the tissue surrounding the stoma. Experience has shown that these ways of controlling a stoma for the presence of necrotic tissue in a real-life stoma can provide a reliable indication as to if the tissue has turned necrotic or not.

Moreover, by providing a model which allows to demonstrate and visualize physical conditions of an ostomy, which conditions may influence the process of applying a stoma appliance around an ostomy, it is believed that more users will become aware of and observant to problematic issues that can be associated with such application process.

The optional feature that the body of the artificial ostomy is “generally cylindrical” shall be understood as in embodiments the body has an overall shape resembling a cylinder, for example, but not exclusively, including, a pipe- or conduit- like element. In embodiments, the body can have open or closed end portions, i.e., in the latter case not having character of a pipe or conduit. It should further be understood that the feature “generally cylindrical” does not exclude that at least the peripheral external surface of the body includes one or more buds or protrusions (seen in cross-section of the body). In other words, the wording “generally cylindrical” also entails implementations wherein the body and/or at least the peripheral external surface thereof is not perfectly rounded or circular or having a continuous, unabrupt extent. Also, “generally cylindrical” can include shapes resembling an oval or ellipse when viewed in cross-section. This is advantageous in order to better demonstrate

DK 2022 70635 A1 13 that real-life stomas rarely have an “ideal” round shape. Research has shown that only about 30% of actual stomas are round or close to round. Many stomas are irregularly shaped. Some irregularities of a stoma may be created during the surgical procedure where the surgeon may have to either “stretch” (or oppositely “fold”) the intestinal tissue in one or more places to stitch the stoma tissue on to the skin surface of the stomach of the user. In embodiments, the peripheral external surface of the body of the artificial ostomy is irregularly shaped. In embodiments, the generally cylindrical body is formed to roughly resemble the shape and size of a real stoma. In embodiments, the body has a diameter (seen in a cross-sectional dimension in a top or bottom view) in a range of 10-150mm.

In embodiments, the artificial ostomy of the demonstration tool includes a third portion extending generally perpendicularly from a longitudinal direction of the body and having a third nuance different from the first nuance and the second nuance. In embodiments, the third portion is a flange extending from the peripheral external — surface of the body. In embodiments, the flange extends from the body adjacent to one of the first end surface or the second end surface. In embodiments, the flange is made from a silicone material cast in a casting process together with the body of the artificial ostomy.

Thereby, the third portion can be applied to e.g. illustrate a portion of peristomal skin surrounding the stoma of a user. In embodiments, the third nuance can be chosen to represent the skin surface of a user of a particular racial profile, such as

Caucasian or African.

In one aspect, the present disclosure relates to a kit of parts comprising at least two demonstration tools for demonstrating physical conditions of an ostomy to a — user of ostomy appliances as disclosed and claimed herein. In embodiments, the kit of parts comprises at least one base plate for an ostomy appliance. In embodiments, the at least one base plate is a mock-up base plate for an ostomy appliance. In embodiments of the kit of parts, a first one of the demonstration tools includes an artificial ostomy having a generally flat body having a height of approximately 1mm and a second one of the demonstration tools includes an artificial ostomy having a height of at least 10mm. In embodiments, the kit of parts includes three or more demonstration tools, such as four demonstration tools, such as five demonstration tools, such as six demonstration tools, such as seven demonstration tools, such as

DK 2022 70635 A1 14 eight demonstration tools, such as nine demonstration tools, such as ten demonstration tools, such as 11 (eleven) or more demonstration tools. In embodiments, the kit of parts includes a packaging suitable for providing (and optionally presenting) and storing the at least two demonstration tools and any further elements of the kit of parts therein. In embodiments, the kit of parts includes instructions for use of the demonstration tools and/or of any further elements comprised in the kit of parts.

In embodiments of the kit of parts, each one of the at least two demonstration tools, such as three or more demonstration tools included in the kit of parts, can be configured to have different peripheral external surface shapes, different cross- sectional dimensions, and/or different heights from the first end surface to the second end surface of the body of the artificial ostomy. Thereby, the kit of parts may advantageously provide an array of artificial ostomies representative of various real- life stoma shapes and sizes. This allows the user or the HCP to pick and combine two — or more different bodies of the artificial ostomies and thereby be able to illustrate many different stoma appearances. In one example, it provides the possibility of combining a “flat” or low-height body (e.g. 1mm height) with a “protruding” or cylindrically shaped body (e.g. 50mm in height) of an artificial ostomy. As mentioned above, during the surgical procedure, a surgeon may have to either “stretch” (or "fold") the intestinal tissue in one or more places to be able to stitch the tissue on to the skin surface of the stomach of the user to create the stoma. In some cases, this has a consequence over time (months or years), in that tissue overgrowth may occur.

Tissue overgrowth in this case means that the intestinal tissue of the stoma grows in and/or onto the peristomal skin surface in the region around the stoma, thereby — creating an irregularly shaped, relatively flat layer of stoma tissue in the peristomal skin zone (surrounding the actual stoma). This phenomenon may be due to muco- cutaneous migration. By combining two or more demonstration tools of the kit of parts, such tissue overgrowth is one type of a physical condition in relation to a stoma which can be illustrated to a user or HCP. Being able to illustrate this and various — other physical conditions in or around a stoma, can advantageously be used in a teaching set-up or process, wherein the user or HCP is being taught about the potential issues and difficulties of applying a base plate for an ostomy appliance, the difficulties in turn depending on the various stoma conditions and/or appearances.

DK 2022 70635 A1 15

Moreover, by providing an array of artificial ostomies including a substantial variety of real-life stoma shapes, sizes, and types in a kit of parts, the kit of parts is particularly useful for introducing new users, and particularly HCPs new to field of ostomy care, to the many different types of stomas they can encounter in the treatment of users or patients.

In embodiments, the generally cylindrical body comprises a liquid-absorbing material provided on the peripheral external surface of the body. In embodiments, the liquid-absorbing material is configured to form a gel or sol on the peripheral external surface of the body upon contact with liquid. In implementations, the gel is a mucin- resembling gel. A mucin-resembling gel is to be understood as being a gel having a likeliness and comparability to mucin emerging on the mucous membrane of a stoma, at least for the purposes of being suitable for the demonstration tool and method disclosed in this application. It is noted that real mucin may not necessarily be, or behave, as a gel.

In implementations, the liquid-absorbing material comprises a superabsorber, a water-absorbing mineral, a hydrocolloid and/or a colouring agent. Including a colouring agent will make it easier to see contamination of the proximal surface of the base plate. Additionally, or alternatively, the liquid-absorbing material can be water swellable (e.g., configured to increase significantly in volume when wetted) and/or can comprise hydrophilic substances.

In embodiments, the body of the artificial ostomy is formed of or comprises a silicone (or silicone-based) material, polyurethane material, a styrene-isoprene-styrene (SIS) polymer material, or a styrene-ethylene-butylene-styrene (SEBS) material. In implementations, the body is formed of or comprises a mixture of SIS and — polyisobutylene (PIB), such as a 50/50 mixture of Kraton 1161 SIS polymer (Kraton) and Oppanol B12 SFN (BASF).

In embodiments, the liquid-absorbing material can be in the form of a powder that is dusted onto the body. An adhesive layer or coating can be applied to the surface of the body to make the powder stick.

In embodiments, the artificial ostomy is formed of a tacky material, such as a tacky silicone material or a tacky polyurethane material. It is advantageous to provide the artificial ostomy in a tacky material in order to more easily apply the liquid- absorbing material to the surface(s) of the body of the artificial ostomy.

DK 2022 70635 A1 16

Embodiments provide for the dusting of a hydrophilic powder material (e.g.,

CMCs, carboxymethyl celluloses) in a fine layer onto the peripheral external surface of the body of the (e.g. tacky) artificial ostomy. Subjecting a dusted model to a watery liquid causes the CMC particles attached to the sticky model to swell and form a — continuous layer of a watery gel on the surface of the artificial ostomy. The continuous layer will be fixated onto the surface due to contributions from both the stickiness of the tacky material and the high viscosity characteristic of the watery gel formed on the surface.

In embodiments, the silicone material forming the body is a soft and somewhat shapable (moldable) silicone-based material which is tacky in itself. This can help to provide an artificial ostomy that can be (pre-)shaped to have an irregular shape when the user will use the artificial ostomy for training. The irregular shape can for example be an oval shape or the peripheral surface of the artificial ostomy can include one or more protrusions in one or more directions “radiating” outward from a common centre. In some embodiments, the moldable material of the body has a modulus which causes the body to require a smaller force for being stretched than the force required to overcome the adhesion provided by the tacky material (the “adhesion modulus” is larger). Thereby, the adhesion force provided by the material is sufficient to keep an irregular shape of the body of the artificial ostomy deformed or “kept in place” once the body is moulded or deformed to have a particular irregular shape. For example, the artificial ostomy can be stretched or moulded into having a generally oval shape (seen in a cross-sectional plan view of the artificial ostomy) and the adhesion force from the tacky material causes the oval shaped artificial ostomy to stay in that oval configuration. By ‘tacky’ is meant slightly sticky. In one embodiment, the silicone-based — material comprises a silicone rubber. In implementations, the silicone rubber is an addition-curing room temperature vulcanization (RTV) silicone rubber, such as a two- part addition curing silicone rubber. As an example, the inventors used WACKER

SilGel® 612 A/B as the silicone rubber, for instance in an A/B ratio of 1:0,9 for a very soft product or 1:0,75 for a soft product. These types of silicone-based materials exhibit an inherent tackiness, i.e., they are slightly sticky. Thus, the peripheral surface of the body comprising such silicone-based material is likewise slightly sticky because of the nature of the chosen material itself. The level of tackiness can be increased by

DK 2022 70635 A1 17 adding an adhesive material to the peripheral external surface of the body of silicone- based material, e.g., provided as a coating on the peripheral external surface.

In embodiments, one or both of the first end surface and the second end surface of the body of the artificial ostomy are tacky. It can be advantageous to have atleast one tacky end surface in order to easily attach the body of the artificial ostomy to a surface (e.g. a table or to another body of a different demonstration model) for demonstration/training purposes.

In embodiments, the generally cylindrical body has a height from the first end surface to the second end surface of 1-100 mm. Suitably, the body is sized to mimic a real-life stoma and can be customized to look like an individual stoma, if relevant. In embodiments, the body has a length in an axial direction between the first and second end surfaces of approximately 60mm. In one implementation, the body has a length in an axial direction of approximately 50mm. In one implementation, the body has a length in an axial direction of approximately 40mm. In one implementation, the body — has a length in an axial direction of approximately 30mm. In one implementation, the body has a length in an axial direction of approximately 20mm.

In embodiments, the kit of parts including two or more demonstration tools further comprises a base connected to the first end surface of the body.

In embodiments of the kit of parts, the base plate is not an actual base plate — for an ostomy device but instead a model or mock-up designed to function like a regular base plate. For instance, the model or mock-up base plate does not necessarily include a collecting bag or coupling means to attach a collecting bag.

When using the demonstration tool according to the disclosure, the user initially prepares the demonstration tool. In embodiments, one or both of the first end — surface and the second end surface of the body include(s) an adhesive. The adhesive is suitably a fastening adhesive such that if, for example, the fastening adhesive is provided on the first end surface of the body, the first end surface can be placed on a suitable planar substrate, e.g., a table-top or on top of another body of an artificial ostomy of a demonstration model and be fastened thereto by the fastening adhesive.

Thereby, the user can place the artificial ostomy in a suitable position for the training exercise and subsequently have both hands free, while being comfortable that the artificial ostomy does not tip over during the demonstration. The adhesive on the end surface can suitably be adapted for temporary fastening of the artificial ostomy to the

DK 2022 70635 A1 18 substrate, i.e., it is not a permanent adhesive fastening. Alternatively, the user can use the adhesive end surface of the body to attach the artificial ostomy to a fingertip, as discussed elsewhere in this disclosure. Alternatively, the user can use at least one of the adhesive end surfaces of the body to attach the artificial ostomy to (at least one — other) body of another artificial ostomy to make a combination (a combination model) thereof, as discussed elsewhere in this disclosure.

It is further understood that in other embodiments, a tackiness of the silicone- based material of the body itself is sufficient to make the artificial ostomy be suitably fastened to the substrate.

In an exemplary practice of using the demonstration model and/or the kit of parts of the present disclosure, the user prepares a base plate of an ostomy appliance for the demonstration exercise. The base plate can include a backing layer having a distal surface and a proximal surface. An adhesive layer is provided on the proximal surface of the backing layer. Optionally, a protective liner (also called a release liner, typically being formed of a surface-siliconized polymeric sheet material) is provided proximally on the adhesive layer, i.e., provided on the adhesive surface of the base plate.

In the event the training session includes an introduction to checking whether or not the stoma tissue is necrotic, the user or HCP may first place the demonstration — model on a substrate, e.g. a table-top, either by simply placing the model on the table or by utilizing adhesive on one end surface of the body of the artificial ostomy to attach the body to the substrate. Next, the user should then examine for necrotic tissue by using one or more fingers to perform a digital examination of the stoma, such as putting a finger into the stoma and manipulate it to “open” or make visible “the — inside tissue” or internal surface of the tissue of the stoma. The described procedure wherein a finger is used to manipulate the internal surface of the body of the artificial ostomy resembles one possible real-life approach to examine for necrotic tissue.

Experience has shown that this manner of controlling a stoma for the presence of necrotic tissue in a real-life stoma provides a reliable indication as to if the stoma tissue is necrotic. In use of the demonstration model according to the present disclosure, the user or HCP should stick a finger “inside” the body of the artificial ostomy and slightly manipulate the material thereof. In embodiments, the internal surface will comprise a relatively darker nuance or colour, which then indicates an

DK 2022 70635 A1 19 example of the presence of necrotic tissue. It is to be understood that the training may be set up such that manipulation of the material of the body of the artificial ostomy does not reveal or show the relatively darker nuance or colour, thereby indicating a healthy stoma (e.g. if the second portion with the relatively darker nuance or colour is not accessible to be manipulated, e.g. if the darker nuance is provided in one end of the body and the corresponding end surface of the body is adhered to the substrate).

In embodiments, wherein a kit of parts comprising at least two different demonstration models are provided, a user or HCP is given the opportunity to choose and combine two or more bodies of the demonstration model to provide a learning set-up or — situation suitable to illustrate a particular physical condition of the stoma and/or of the skin around the stoma). This could be a situation including tissue overgrowth of the stoma tissue on the peristomal skin around the stoma where a relatively flat layer of tissue has been created, thereby making it challenging to optimally adapt the placing/locating of the base plate on the skin and/or optimally adapting the size — and/or shape of the stoma-receiving opening in the base plate.

In some embodiments, the user or HCP can further subject a liquid-absorbing material on the peripheral external surface of the artificial ostomy to a liquid.

Subjecting the liquid-absorbing material to liquid causes the liquid-absorbing material on the peripheral external surface of the body to develop a gel, preferably resembling mucin(s) and/or components thereof.

As described, the body of the artificial ostomy in some embodiments includes tacky and/or adhesive first and/or second end surface(s). With that configuration, the user can advantageously press the tip of a finger onto the tacky or adhesive end surface of the body to adhere the artificial ostomy to the fingertip. Subsequently, and — further advantageously, the user can subject the artificial ostomy sitting on the fingertip to the liquid, e.g., by dipping the artificial ostomy into a container with water.

In embodiments of the kit of parts, the user can further be provided with the possibility of optionally removing a protective liner optionally provided proximally on the adhesive layer of the base plate provided with the kit of parts. In other embodiments, the protective liner can be left out of the base plate or, alternatively, the user can choose to refrain from removing the protective liner on the proximal adhesive surface of the base plate before engaging the base plate with the artificial ostomy.

DK 2022 70635 A1 20

In embodiments including a body of an artificial ostomy having a certain length or height, e.g. such as 50mm, resembling a protruding stoma, the user of HCP can engage the base plate around the artificial ostomy and advance it substantially along an entirety of the length of the body to a “root” of the artificial ostomy at the first end thereof. However, it is also acceptable that the base plate is advanced along only a smaller/shorter portion of the body of the artificial ostomy.

In embodiments, the body of the artificial ostomy is reusable. For example, after use, the body of the artificial ostomy can be rinsed in water, and optionally dried.

In embodiments, the dried body can then be provided with a fresh layer or coating of liquid-absorbing material on the peripheral external surface of the body

Description of the drawings

Figure 1A is a schematic, cross-sectional, side view of one embodiment of a — body (1) of an artificial ostomy of a demonstration tool (10) for demonstrating physical conditions of an ostomy to a user of ostomy appliances. In Fig. 1A, the body is generally cylindrical. The generally cylindrical body (1) is shown with a peripheral external surface (2), a first end surface (3) and a second end surface (4). In the embodiment of Figure 1A, the generally cylindrical body has a second opening (5b) in — the second end surface (4). However, it should generally be understood that the second opening (5b) can also be provided in a portion of peripheral external surface, such as adjacent the second end surface (4) (i.e. in a “side” of the body) to illustrate the condition that not all stomas in real-life exude output from their end, but often do so “to the side”. The body (1) can also include a first opening (5a) in the first end — surface (3), indicated by broken line in Figure 1A. In embodiments, the body (1) includes an internal passage (8) extending inside the body (1) between the first opening (5a) and the second opening (5b). A liquid-absorbing material (7) is illustrated (punctured line) to be provided on the peripheral external surface (2) of the body (1).

As described above, the term “generally cylindrical body” shall be understood — as embodiments wherein the body has an overall shape resembling a cylinder. It should further be understood that the feature "generally cylindrical body” does not exclude that the peripheral external surface of the body includes one or more buds or protrusions (seen in cross-section of the body), although not illustrated in Fig. 1A.

DK 2022 70635 A1 21

Figure 1B is a schematic, perspective illustration of another embodiment of a generally cylindrical body (1) of an artificial ostomy. In Figure 1B, the body (1) is formed to roughly resemble the shape and size of one example of a real-life stoma.

Figure 1B illustrates one embodiment wherein at least a first portion of the body (1) corresponding to the peripheral external surface (2) of the artificial ostomy is made from a light-coloured silicone material. The body (1) of the artificial ostomy is located on a base (6). The body (1) of the artificial ostomy can be permanently or detachably attached to the base (6). As can be understood from Figure 1B, the “generally cylindrical body” (1) of the artificial ostomy includes embodiments wherein the body (1) is not perfectly rounded or circular, as is best illustrated at the “root” of the body (1) where the first end surface (3) engages with the base (6) and the peripheral external surface (2) of the body (1) has some irregularities. Thus, Figure 1B also illustrates cases wherein a stoma was created with irregularities during the surgical procedure, because the surgeon had to manipulate the tissue of the intestine to be able to stitch it on to the skin surface of the stomach of the user (skin surface e.g. resembled by the base (6)).

In the embodiment of Figure 1B, at least the first end surface (3) is tacky whereby the body (1) of the artificial ostomy can conveniently and/or easily be attached to the base (6) for demonstration/training purposes by adhesion. As can be — understood from Figure 1B, in embodiments of a kit of parts according to the disclosure, at least two demonstration tools (10) are included. The kit of parts may include further elements such as the base (6). In the embodiment of Figure 1B, the base (6) is connected to the body (1) at the first end surface (3).

The peripheral surface (2) of the body (1) as illustrated by the embodiment of

Figure 1B can also comprise a material which in itself is tacky (or made sticky) to provide the liquid-absorbing material on the body (1), the liquid-absorbing material (7) not shown in Fig. 1B.

In embodiments, the body (1) has a height “h” from the first end surface (3) to the second end surface (4) of 1-100 mm. In the example illustrated in Figure 1B, the — height “h" of the body (1) is approximately 30mm (figures not to scale).

Fig. 1C schematically illustrates one embodiment of a kit of parts (200) including a first demonstration tool (10) including a body (1) of an artificial ostomy and a second demonstration tool (11) including body (150) of an artificial ostomy. A first

DK 2022 70635 A1 22 end surface of the body (1) of the first demonstration tool (10) is attached to a second end surface (154) of the body (150) of the second demonstration tool (11), e.g. by means of an adhesive on one or both of the end surfaces (3) and (154). Also indicated is second end surface (4) of body (1). In Fig. 1C, the second demonstration tool (11) with a "flat" or low-height body (154) (e.g. 1mm in height) is combined with the first demonstration tool (10) having a “protruding” or cylindrically shaped body (1) (e.g. 50mm in height). In Figure 1C, the body (154) of the second demonstration tool (11) particularly serves to illustrate and resemble the situation of tissue overgrowth of the intestinal tissue of a stoma in or on the peristomal skin surface in the region around the stoma resembled by body (1) of the first demonstration tool (10). The body (154) resembles a relatively flat layer of stoma tissue in the peristomal skin zone (surrounding the actual stoma resembled by body (1)). By combining two or more demonstration tools (10, 11) of the kit of parts (200), such tissue overgrowth is one type of a physical condition in relation to a stoma which can be illustrated to a user or

HCP for training purposes.

Fig. 1D is a schematic, perspective illustration of a body (1) of an artificial ostomy of one embodiment of a demonstration tool (10) according to the present disclosure. Figure 1D illustrates an embodiment wherein at least a first portion (1a) of the body (1), corresponding to the peripheral external surface (2) of the body (1), is — made with a light-coloured silicone material. A second portion (1b), in the embodiment of Fig. 1D providing an internal surface of the body (1), is made with a relatively darker nuance, such as a dark-red colour. In Fig. 1D, the darker nuance is indicated by cross- hatching of the second portion (1b). In other embodiments, other portions of the body (1) can be provided with a darker nuance, such as for example an end portion (9) of the body (1). The demonstration tool (10) including the body (1) of the artificial ostomy is configured such that the second, relatively darker nuance of the second portion (1c) resembles the presence of necrotic stomal tissue and can be configured to be made visible only when the user or HCP using the demonstration tool (10) manipulates the body (1) with one or more fingers. For example, the demonstration tool can be configured to allow inspection of the second portion with the relatively darker nuance only if the user or HCP manipulates the internal surface providing the second portion (1b) of the body (1) with a finger. Such a configuration of the artificial ostomy can reflect the behaviour and appearance of a real-life stoma in situations. The relatively

DK 2022 70635 A1 23 darker nuance will then reflect the “fact” that the stoma suffers from the formation of necrotic tissue. The body (1) can be configured such as to “close” again upon itself after removal of the finger or tool, thus, again resembling behaviour of real-life stomas.

In the embodiment of Figure 1D, the first end surface (3) of body (1) is tacky whereby the body (1) of the artificial ostomy can conveniently and/or easily be attached to a substrate by adhesion. In the illustrated embodiment of Fig. 1D, the peripheral external surface (2) of the body (1) further includes a liquid-absorbing material (7) provided on the peripheral external surface of the body (1).

Figures 2A-C is a series of three illustrations demonstrating, in schematic, cross-sectional, side views, at least some exemplary steps in a practice for demonstrating to a user of an ostomy appliance an impact of stomal mucin- contamination of a base plate (23) including applying a base plate (23) around the generally cylindrical body (1) according to one embodiment of the body of the artificial ostomy of the demonstration tool (10). In examples, the user prepares a base plate (23) of an ostomy appliance for the demonstration exercise. In embodiments, the base plate (23) includes a backing layer (21) having a distal surface and a proximal surface.

An adhesive layer is provided on the proximal surface of the backing layer and provides a proximal surface (25) of the base plate (23). Optionally, a protective liner is — provided on and protects the adhesive surface (25) of the base plate (23) (not shown).

Figure 2A shows one embodiment of a generally cylindrical body (1) of an artificial ostomy and a base (6) on which the generally cylindrical body (1) is mounted.

A layer resembling a mucin-like gel (22) is illustrated on the peripheral external surface of the body (1). The layer resembling the mucin-like gel (22) is created by subjecting — theliquid-absorbing material (7) shown in Figure 1A to liquid or moisture. In examples, subjecting the liquid-absorbing material to liquid includes dipping the body (1) of the artificial ostomy into a container with liquid (not shown). In examples, the user can advantageously subject the artificial ostomy to the liquid in the container with the body (1) “sitting” on the outer portion of the user's finger due to adhesion to the tacky first end surface (3) of the body (1) (Figure 1A). In Figure 2B is seen a base plate (23) being applied in the direction of the arrows over the body (1). In Figure 2C the base plate has been applied all the way to the base (6) and the base plate is illustrated as having been compromised with a contamination (24) of the mucin-like gel (22),

DK 2022 70635 A1 24 particularly at a part of the base plate (23) close to the artificial ostomy. Thus, in a demonstration/training set-up, the user can engage the base plate (23) around the body (1) of an artificial ostomy and advance it substantially along an entirety of the length of the body (1) to a “root” of the artificial ostomy at the first end thereof (Figure 20).

Figures 3A-D is a series of illustrations demonstrating, in schematic top and cross-sectional side views, a process of squeezing a drop of liquid (31) between two glass plates (30, 34), which is intended to illustrate the mechanism behind one of the problems occurring when applying a base plate of an ostomy appliance around a stoma. In figures 3A (top view) and 3B (cross-sectional side view), a droplet of coloured liquid (31), resembling a droplet of mucin and coloured to enhance visibility, is placed on a glass plate (30) illustrating the human skin. In Figures 3C (top view) and 3D (cross-sectional side view), a second glass plate (34), illustrating a base plate of an ostomy appliance, is placed over the droplet (31), and the droplet (31) is thereby squeezed between the glass plates (30, 34) and spread out over a larger area. The contour and extent of the spread-out droplet (31) is drawn up in Figure 3D to visualize an area now being contaminated with liquid. As can be seen, the droplet (31) of liquid has now been squeezed and thus covers a substantial portion of the glass plate (30). It is belleved that this same mechanism applies on the adhesive surface of a base plate — having been subjected to mucin from the stoma surface when the base plate is being applied to the peristomal skin surface around the stoma (due to contacting or even scraping off mucin during the passage of the stoma through the stoma-receiving opening of the base plate). In Figures 3C and 3D, the spread-out droplet (31) is illustrated in a shaded manner to illustrate examples wherein the liquid-absorbing — material (7) includes a colouring agent (32) to make it easier to see the mucin- resembling contamination on the glass plates (30, 34) or on proximal surface of a base plate (32) (Figures 2A-C).

For comparison of embodiments of the demonstration tool and exemplary method described above with the process of applying a base plate around a real stoma, Figure 4A is a schematic drawing showing a user's stoma S and peristomal skin surface P and with an indication of mucin being formed on the surface 48 of the stoma S.

DK 2022 70635 A1 25

Figure 4B is a schematic drawing showing a base plate (23) being guided in the direction of the arrows A to a desired position adjacent the peristomal skin surface P with the user's stoma S engaging a stoma-receiving opening (35) in the base plate (23) and with an indication of mucin (46) being formed on the surface (48) of the stoma S and also have begun seeping onto the peristomal skin surface P.

Figure 4C is a schematic drawing showing the base plate in a desired position adjacent the peristomal skin surface P with the user's stoma S engaging the stoma- receiving opening (35). Mucin, on the peristomal skin surface P, and in some cases also from the stoma surface (48), is shown to compromise the base plate (23).

Figure 5 is a schematic illustration of five different stoma profiles that are representative, but not exhaustive, for a stoma population. Stoma a) is identified as a retracted stoma; stoma b) as a flush stoma; c) as a low-profile stoma; d) as a protruding stoma and e) as a prolapsing stoma. The demonstration/training tool (10) according to the disclosure can include any one of the shown stoma profiles and achieve the advantageous purpose of demonstrating to a user of ostomy appliances an impact of mucin-contamination of a base plate during application of the base plate around the ostomy. A kit of parts according to the disclosure can include demonstration tools including artificial ostomies resembling two or more of each of the stoma profiles exemplified in the array of different stoma profiles in Fig. 5.

Figure 6 is a schematic view of a kit of parts (200) including a first demonstration tool (10) including a fist body (1) of an artificial ostomy and a second demonstration tool (11) including a second body (154) of another artificial ostomy.

The first body (1) is shown adhered to the second body (154) at a first end surface (3) of the first body (1). In the embodiment of the kit of parts (200) of Figure 6 the kit — further includes an ostomy appliance (100) including a base plate (23) and a collecting bag (15) adapted to engage with the base plate (23). Figure 6 schematically illustrates one embodiment of the body (1) of the artificial ostomy of the demonstration tool (10) wherein the body (1) is provided with a liquid-absorbing material (7) on a peripheral external surface of the body (1).

Although specific implementations/embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific implementations shown and described without departing from the scope of

DK 2022 70635 A1 26 the present invention. This application is intended to cover any adaptations or variations of body side members for ostomy appliances as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.

Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather — than restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

Claims (22)

DK 2022 70635 A1 27 CLAIMS

1. A demonstration tool for demonstrating physical conditions of an ostomy to a user of ostomy appliances, comprising: an artificial ostomy comprising a body having a peripheral external surface, and a first end surface, and a second end surface, wherein at least a first portion of the body has a first light nuance, and a second portion of the body has a second, relatively darker nuance.

2. The demonstration tool of claim 1, wherein the body of the artificial ostomy is generally cylindrical.

3. The demonstration tool of any one of claim 2, wherein the body of the artificial ostomy comprises an internal surface.

4. The demonstration tool of claim 3, wherein the peripheral external surface, the internal surface, and the first end surface, and the second end surface of the artificial ostomy combine to form the generally cylindrical body.

5. The demonstration tool of any one of the preceding claims, wherein the first portion of the body of the artificial ostomy having a first light nuance has a light colour and the second portion of the body having a relatively darker nuance has a dark colour.

6. The demonstration tool of any one of the preceding claims, wherein the first lighter nuance of the first portion of the body is a light red colour and the second nuance of the second portion of the body is a dark red colour.

7. The demonstration tool of claim 5, wherein the first light nuance of the first portion of the body and the second, relatively darker nuance of the second portion of the body are provided as various nuances of red and brown or black, respectively.

DK 2022 70635 A1 28

8. The demonstration tool of any one of claims 3-7, wherein the internal surface of the body of the artificial ostomy comprises a first zone adjacent the first end surface of the body and a second zone being closer to the second end surface of the body than the first zone.

9. The demonstration tool of claim 8, wherein the first zone of the internal surface has a light red colour and the second zone of the internal surface has a black colour.

10. The demonstration tool of any preceding claim, wherein the artificial ostomy is formed of a silicone material or a polyurethane material.

11. The demonstration tool of claim 11, wherein the silicone material comprises an addition-curing two-part silicone rubber.

12. The demonstration tool of any preceding claim, wherein the body has a height from the first end surface to the second end surface of 1-100 mm.

13. The demonstration tool of any one of the preceding claims, wherein the peripheral external surface of the body of the artificial ostomy is irregularly shaped.

14. The demonstration tool according to any one of the preceding claims, wherein the body has a diameter in a range of 10-150mm.

15. The demonstration tool according to any one of the preceding claims, further comprising a third portion extending generally perpendicularly from a longitudinal direction of the body and having a third nuance different from the first nuance and the second nuance.

16. The demonstration tool according to claim 15, wherein the third portion is a flange extending from the peripheral external surface of the body.

DK 2022 70635 A1 29

17. A kit of parts comprising at least two demonstration tools according to any one of claims 1-16.

18. The kit of parts of claim 17, wherein a first one of the demonstration tools includes an artificial ostomy having a generally flat body having a height of approximately 1mm and a second one of the demonstration tools includes an artificial ostomy having a body having a height of at least 10mm.

19. The kit of parts of any one of claims 17 or 18, comprising three or more demonstration tools, such as four demonstration tools, such as five demonstration tools, such as six demonstration tools, such as seven demonstration tools, such as eight demonstration tools, such as nine demonstration tools, such as ten demonstration tools, such as 11 (eleven) or more demonstration tools.

20. The kit of parts of any one of claims 17-19, comprising a packaging suitable for providing and storing the at least two demonstration tools and any further elements of the kit of parts therein.

21. The kit of parts of any one of claims 17-20, comprising at least one base plate for an ostomy appliance.

22. The kit of parts of any one of claims 17-21, comprising instructions for use of the demonstration tools and/or of any further elements comprised in the kit of parts