Application aids for ostomy devices

Abstract

An application aid (10) suitable for assisting a user in applying an adhesive base plate (20) of an ostomy device to a skin surface around a user's stoma, the adhesive base plate including a first adhesive surface (30) facing the skin and a second surface (40) facing away from the skin, the application aid being configured to be removably attached to the base plate and adapted to at least partially surround the user's stoma during application of the base plate to the skin surface around the user's stoma, the application aid including a base portion (70) and a protective member (80) disposed on a surface of the base portion and adapted to prevent mucus from the stoma mucosa from contaminating the base plate during application of the base plate to the skin surface around the user's stoma.

Description

Background Technology

[0001] Ostomy discharge often contains bodily fluids and visceral contents that are corrosive to both the user's skin and the ostomy device, particularly impacting the efficiency and integrity of adhesive materials used to attach the device to the user's skin. Some ostomists may choose or must wear their devices for extended periods. Reliable and effective ostomy devices are essential for the general user, and especially for the safety of these ostomists. Numerous attempts have been made to provide ostomy devices that meet these needs, such as the requirement for extended wear times; however, providing sufficient efficiency to achieve a satisfactory long wear time remains an unmet need.

[0002] Ostomy practitioners and healthcare professionals will welcome improvements in ostomy devices to better meet these needs. Summary of the Invention

[0003] This disclosure provides several aspects of an application aid, according to the appended claims, suitable for assisting a user in applying an adhesive base plate of an ostomy device to the skin surface around the user's stoma without contaminating the adhesive base plate. Attached Figure Description

[0004] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain the principles of the embodiments. Other embodiments and many of the advantages of the embodiments will be readily appreciated as they will become better understood by referring to the following detailed description. The same reference numerals indicate corresponding similar parts.

[0005] In the following description, various exemplary embodiments and details are illustrated with reference to the accompanying drawings, where applicable. It should be noted that the drawings may or may not be drawn to scale, and the same reference numerals are used throughout all drawings to denote elements having similar structures or functions. It should also be noted that the drawings are intended only to facilitate the description of embodiments. They are not intended as an exhaustive description of the invention or a limitation on its scope. Furthermore, the illustrated embodiments are not necessarily to have all the aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment even if not so shown or so explicitly described.

[0006] Figure 1 This is a schematic cross-sectional view of one embodiment of an application aid arranged on the base plate.

[0007] Figure 2This is a schematic cross-sectional view of another embodiment of the application aid arranged on the base plate.

[0008] Figure 3 and Figure 4 A near-side view of an embodiment of an application aid including a strip arranged on a base plate is shown.

[0009] Figure 5 An embodiment of an application aid with a pleated base component is shown.

[0010] Figure 6 An embodiment of an application aid that is cut into strips at the bottom is shown, the application aid being arranged on a base plate.

[0011] Figure 7 This is an embodiment of an application aid that is cut into strips at the bottom.

[0012] Figure 8a and Figure 8b The diffusion of droplets is shown when squeezed between glass plates. Detailed Implementation

[0013] In the following detailed description, reference is made to the accompanying drawings, which form part of the detailed description, and which illustrate specific embodiments in which the invention can be practiced. In this regard, directional terms such as “top,” “bottom,” “front,” “rear,” “leading,” “rear,” etc., are used with reference to the orientation of the described drawings. Because components of the embodiments can be positioned in multiple different orientations, the directional terms are for illustrative purposes and are by no means limiting. It should be understood that other embodiments can be utilized and structural or logical changes can be made without departing from the scope of the invention. Therefore, the following detailed description should not be considered limiting, and the scope of the invention is defined by the appended claims.

[0014] It should be understood that, unless otherwise specifically indicated, the features of the various exemplary embodiments described herein can be combined with each other.

[0015] Throughout this disclosure, the terms “ostomy” and “ostomy procedure” are used to refer to an opening created surgically around a person’s intestinal or urinary tract system. These terms are used interchangeably and do not have distinguishing meanings. This also applies to any words or phrases derived from these terms, such as “ostomy,” “ostomy procedure,” etc. Furthermore, solid and liquid waste from the ostomy can be used interchangeably as ostomy “excretions,” “waste,” and “fluid.” A subject undergoing an ostomy procedure may be referred to as an “ostomy patient” or “ostomy person,” and also as a “patient” or “user.” However, in some cases, “user” may also refer to or refer to a healthcare professional (HCP), such as a surgeon or ostomy care nurse or other personnel. In these cases, it will be explicitly stated or implied from the context that the “user” is not the “patient” himself or her.

[0016] In the following text, whenever the proximal side of a device or part of a device is mentioned, it refers to the side facing the skin when the user wears the ostomy instrument. Similarly, whenever the distal side of a device or part of a device is mentioned, it refers to the side facing away from the skin when the user wears the ostomy instrument. In other words, the proximal side is the side closest to the user when the instrument is fitted on the user, and the distal side is the opposite side, that is, the side furthest from the user during use.

[0017] When a user wears the device, the axial direction is defined as the direction of the stoma. Therefore, the axial direction is approximately perpendicular to the user's skin or abdominal surface.

[0018] The radial direction is defined as transverse to the axial direction, that is, transverse to the stoma. In some statements, the terms "inner" and "outer" may be used. These qualifiers should generally be understood with reference to the radial direction, thus referring to an "outer" element as one that is farther from the center of the stoma instrument than an element referred to as "inner." Furthermore, "innermost" should be interpreted as the part of the component forming the center and / or the portion adjacent to the center of the component. Similarly, "outermost" should be interpreted as the outer edge or outer contour of the component forming the outer edge or outer contour and / or the portion adjacent to that outer edge or outer contour.

[0019] The use of the phrase “substantially” in this disclosure as a modifier for certain characteristics or effects is intended to simply indicate that any deviations are within tolerances that would normally be expected by a person skilled in the art.

[0020] In one aspect, this disclosure relates to an application aid suitable for assisting a user in applying an adhesive base plate of an ostomy device to a skin surface around a user's stoma. The adhesive base plate includes a first adhesive surface facing the skin and a second surface facing away from the skin. The application aid is configured to be removably attached to the base plate and adapted to at least partially surround the user's stoma during application of the base plate to the skin surface around the user's stoma. The application aid includes: a base member including a first surface and a second surface, the first surface being configured to be positioned in a direction away from the skin around the stoma and / or away from the stoma, and the second surface being configured to be positioned in a direction toward the skin around the stoma and / or toward the stoma; and a protective member disposed on the second surface of the base member and adapted to prevent mucus from the stoma mucosa from contaminating the base plate during application of the base plate to the skin surface around the user's stoma; wherein at least a portion of the first surface of the base member is configured to engage a peripheral edge of an opening in the base plate that receives the stoma.

[0021] During the application of the baseplate to the skin around the stoma, extreme care must be taken to avoid contaminating the adhesive surface of the baseplate with mucus from the stoma mucosa and / or drainage fluid from the stoma (stoma waste). However, especially with adhesives designed to prevent mucus contamination of the baseplate, it has been found that this can be difficult to avoid. Furthermore, surveys indicate that users pay far less attention to avoiding mucus than to avoiding stoma drainage fluid when applying the baseplate. The holes in the baseplate are cut to fit around the stoma, leaving very little extra space around the stoma during application. The risk of the stoma contacting the edges of the baseplate during application is high, and even small drops of mucus can spread and wet (contaminate) a significant area of ​​the adhesive surface when the baseplate is subsequently pressed against the skin around the stoma. The varying sizes and shapes of all stomas make the task of avoiding contamination of the adhesive surface of the baseplate even more challenging. Additionally, when the baseplate is applied to the user's abdomen, it is often difficult for the user to see what he or she is doing.

[0022] When sludge gets into the adhesive surface of the base plate, the adhesive's stickiness may be temporarily or permanently reduced, thus creating space / channels for leaks that may have already begun and caused damage.

[0023] Even a tiny drop of adhesive on the surface can cause serious damage. This is in Figures 8a to 8b The image shows a drop of colored liquid (representing mucus, colored to improve visibility) placed on a glass plate (representing skin). Figure 8bIn this process, a second glass plate (display substrate) is placed on the droplet, thereby compressing and spreading the droplet over a larger area. The outline of the spreading droplet is plotted to visualize the area now contaminated by the liquid. It can be seen that the droplet is now squeezed out to cover a significant portion of the glass plate. It is believed that the same mechanism applies to the adhesive surface of the baseplate, which has already been exposed to mucus splatter, when the baseplate is applied to the skin surface around the stoma. Therefore, the adhesive may have been "damaged" or "weakened" due to the attachment of the new baseplate, which could reduce the total wear time of the baseplate.

[0024] In this article, stoma management refers to stoma surgery, iliac crest stoma surgery, and urostomy, because in these cases, there may be issues with contamination of the baseplate adhesive surface.

[0025] In several respects, the application of the adjuvant helps to safely apply the adhesive around the stoma by reducing or eliminating the risk of adhesive contamination during application, by eliminating the possibility of mucus (stoma fluid) contaminating the adhesive surface of the opening surrounding the stoma and the baseplate, and by removing almost invisible oozing stoma fluid near the skin around the stoma before the adhesive baseplate comes into contact with the skin.

[0026] In embodiments, the base member may include a neck portion that extends axially outward from the peripheral edge of the stoma receiving opening. The neck portion may be substantially concentric with the stoma. In embodiments, the distal end of the neck portion is wider than the proximal end. In embodiments, the neck portion may have a generally circular cross-section. In embodiments, the neck portion extends as a tube surrounding the stoma, or may take the form of one or more (separate) strips extending in an axial direction. In embodiments, the cross-section of the neck portion is configured to conform to the shape of the peripheral edge of the stoma receiving opening. During application, the neck portion may protect the base plate from direct contact with the stoma and may protect the stoma from direct contact with the surrounding environment. In embodiments, the neck portion partially or completely lining the peripheral edge of the stoma receiving opening of the base plate. In embodiments, the neck portion surrounds the stoma and includes axial cuts to allow the neck portion to conform to stomas of larger or smaller diameters.

[0027] In one embodiment, the neck portion has a height of at least 1 mm, such as at least 5 mm, such as at least 10 mm, measured axially outward from the opening receiving the stoma. In another embodiment, the height of the neck portion is 1-70 mm, such as 1-60 mm, such as 1-50 mm, such as 5-40 mm, such as 8-30 mm, such as 10-25 mm. In yet another embodiment, the height of the neck portion is at least equal to the thickness of the base plate.

[0028] In one embodiment, the neck portion of the base member includes a tab member to facilitate easy removal of the application aid by pulling the tab member. In another embodiment, the tab may be an outward extension of the base member. In yet another embodiment, the tab is in the form of a loop configured to allow insertion of a finger through it.

[0029] In one embodiment, the base member includes a bottom portion that extends radially outward from the peripheral edge of the stoma receiving opening. In another embodiment, the bottom portion extends from a first end portion of the base member and faces the periphery of the stoma receiving opening. In yet another embodiment, the bottom portion is positioned proximal to the base plate to at least protect the adhesive surface of the base plate closest to the stoma receiving opening.

[0030] In one embodiment, the bottom portion of the base member extends over a portion of the first adhesive surface of the base plate. Therefore, during application, the bottom portion protects the adhesive surface from mucus contamination from the stoma mucosa. In another embodiment, the distal surface of the bottom portion includes a release surface. A release surface is a surface that is easily released from the adhesive, such as a silicone surface. When the base member needs to be removed, such a surface allows the base member / bottom portion to be easily separated from the adhesive surface of the base plate.

[0031] In one embodiment, the base component includes one or two strips. In another embodiment, the strip(s) comprise sheets cut into one or more strips. In another embodiment, the strips are aligned in an axial direction. In another embodiment, the strips are folded, wherein a first strip portion is configured to be positioned away from the peristaltic skin and / or away from the stoma, thereby defining a first surface of the base component, and a second strip portion is configured to be positioned facing the peristaltic skin and / or facing the stoma, thereby defining a second surface of the base component and a fold line at the bottom portion. These configurations can facilitate a rolling motion of the one or more strips when the neck end of the second strip portion is pulled, thereby removing the strip from the adhesive surface by rolling. In another embodiment, the strips are joined together at the neck portion to form a single sheet, but are separated at the bottom portion to form two or more discrete strips thereon.

[0032] In one embodiment, the strips include one or more pull tabs. In another embodiment, the second strip portion has a pull tab at its neck portion, extending further than the first strip portion to allow for easier gripping of the tab.

[0033] In this embodiment, the bottom portion of the strips is wider than the neck portion. This helps the bottom portion to cover a larger portion of the adhesive surface near the stoma opening.

[0034] A protective component is disposed on a second surface of the base component. The protective component may completely or only partially cover the second surface. In embodiments, the protective component comprises an absorbent material. The protective component may include an absorbent mesh, fabric, paper, tissue paper, textile, or nonwoven fabric. In embodiments, the protective component comprises an absorbent powder or coating. Examples of suitable powders or coatings are hydrocolloids, such as, but not limited to, CMC (carboxymethyl cellulose). In embodiments, the absorbent powder is sprinkled onto the second surface of the base component. In embodiments, the protective component is lined, laminated, sprayed on, or sprinkled onto the second surface of the base component. In embodiments, the protective component includes a "hairy" surface.

[0035] The protective component can absorb stoma fluid or mucus that enters the second surface of the application aid. Furthermore, when stoma fluid or mucus seeps from the stoma and moistens the skin around the stoma—perhaps forming only a thin, almost invisible layer, but still sufficient to break the adhesive—this layer can be absorbed by the protective component and thus removed without interfering with or damaging the adhesive surface of the baseplate.

[0036] In one embodiment, the protective member is positioned on the second surface of the bottom portion of the base member. In another embodiment, the protective member is also disposed on the neck portion.

[0037] In one embodiment, the protective component is disposed on the neck portion of the base component.

[0038] In one embodiment, at least a portion of the base member is pleated. These pleats allow compression of the neck portion of the base member, while the pleats can be flattened more in the bottom portion.

[0039] In an embodiment, the bottom portion extends 1-20 mm, for example 1-10 mm, on the adhesive surface of the base plate, measured radially outward from the outer edge of the opening receiving the stoma.

[0040] In embodiments, the base component is formed of a thin film material, foil material, nonwoven material, fibrous material, or paper material. In embodiments, the base component is a flexible sheet material that is stiff enough to maintain its shape but flexible enough to bend around the outer edge (edge) of the opening receiving the ostomy. In embodiments, the base component includes an elastic material.

[0041] In several respects, this disclosure relates to a parts kit comprising an adhesive base plate and an application aid of claim 1, wherein the application aid is an accessory component that is attached to the base plate before or during application of the base plate to the skin.

[0042] When the stoma baseplate is ready to be applied to the skin around the stoma, select or adjust the opening size according to the stoma's contour. Instruct the user to cut the opening shape so that the baseplate adhesive adheres only to the skin (not to the stoma) and is 1 mm away from the skin boundary before reaching the mucosa (stoma). Because the baseplate opening must be slightly larger than the stoma size, the adhesive may be unintentionally contaminated before bonding to the skin to avoid damage to the skin from moisture (maceration) or corrosive discharge (enzymes). This has been found to occur frequently because the inner periphery of the baseplate opening comes into contact with and "scrapes away" stoma fluid (mucin and water) when the adhesive baseplate is moved toward the skin for adhesion. It has also been found that in some cases, a nearly invisible layer of mucus or stoma fluid is already present at the stoma root and / or near the skin around the stoma. This layer of mucus should be removed to allow the baseplate to adhere well to the skin.

[0043] In one embodiment, the application aid is provided as an integrated part of the base plate, and in a sense, the base plate is delivered while the application aid is installed. After application, the application aid is removed.

[0044] In this embodiment, the application aid is a separate component that can be applied to the base plate before use. The application aid may be a single-use product, or it may be reused on a new base plate, for example, after cleaning the application aid.

[0045] The application aid can be applied to both one-piece and two-piece stoma devices. In embodiments of a one-piece stoma device, the application aid can be configured to be removed from the base plate and inserted into a collection bag. In embodiments of a two-piece device, the application aid can be removed before the collection bag is attached to the base plate.

[0046] In this embodiment, the application of the auxiliary component is a two-piece system in which one or more parts are replaceable. For example, the protective component may be replaceable to facilitate the reuse of the base component.

[0047] In one embodiment, an accessory is applied around the stoma, but optionally the accessory is applied in a way that allows it to be adapted to fit a stoma of any size and shape.

[0048] In an embodiment, the present invention relates to a parts kit comprising an adhesive base plate and an application aid of claim 1, wherein the application aid is an accessory component that is attached to the base plate before or during application of the base plate to the skin.

[0049] The embodiments relate to a method for preventing contamination of the adhesive surface of a stoma floorboard during application, the method comprising the steps of:

[0050] a. Provide application aids in accordance with this disclosure;

[0051] b. Provide an adhesive base plate

[0052] c. Arrange the application auxiliary components on the base plate.

[0053] d. Apply the baseplate to the skin around the stoma; and

[0054] e. Remove the applied auxiliary component.

[0055] The embodiments further relate to a method for preventing contamination of the adhesive surface of a stoma floorboard during application, the method comprising the steps of:

[0056] a. Provide application aids in accordance with this disclosure;

[0057] b. Provide an adhesive base plate

[0058] c. Apply the application aid to the skin around the stoma;

[0059] d. Apply the baseplate to the skin, ensuring the opening of the baseplate mates with the application aid; and

[0060] e. Remove the applied auxiliary component.

[0061] When applying the baseplate to the skin around the stoma, position it so that the stoma aligns with the opening and the baseplate contacts the skin around the stoma, with the stoma protruding through the opening. Since the opening in the baseplate is typically only slightly larger than the stoma, positioning the baseplate so that it does not contact the stoma can be difficult, if not impossible. Even small drops of mucus have been found to reduce the adhesive's stickiness. Aligning and applying the baseplate without allowing mucus to enter the adhesive surface requires a high degree of dexterity, good visibility (which may be affected by the abdomen), and considerable luck. Application aids can reduce the risk of baseplate adhesive contamination by providing protection to the adhesive surface around the opening. Attached Figure Description

[0063] Figure 1An embodiment of an application aid (10) mounted on a base plate (20) is shown. The base plate includes a first skin-facing adhesive surface (30) and a second skin-facing surface (40). The second surface (40) typically has a backing layer (50) and a device for attaching a receiving bag (not shown). The base plate (20) has an opening (60) for receiving an ostomy. The application aid includes a base member (70) facing away from the skin / ostomy and a protective member (80) closest to the skin / ostomy. During the application of the base plate (20) to the skin, the ostomy may come into contact with the application aid (10) – or drip mucus onto it, and this liquid is removed, for example, by being absorbed or drained by the protective member (80) instead of being smeared onto the adhesive surface (30). A release layer (not shown) is provided on the surface of the base member (70) facing the adhesive surface (30) to facilitate easy release of the base member (70) from the adhesive layer (30) when the application aid (10) is to be removed.

[0064] Figure 2 An embodiment of the application aid (10) is shown, wherein the base components (72, 74) are folded to form a double layer folded (100) at the bottom portion (120). The first layer (74) of the base component facing the adhesive surface (30) covers the second layer (72) facing the stoma and skin. At the neck portion (110), the second layer (72) is provided with a tab (90). When the base plate (20) has been applied to the user's skin surface, the tab (90) can be pulled, thereby "rolling" the application aid (10) off and removed.

[0065] Figure 3 and Figure 4 This is a close-up view of an embodiment of the application of the auxiliary component, wherein the base component comprises four strips (120) that are double-layered and have fold lines (100) on their bottom portions furthest from the opening (60) of the receiving stoma. These four strips (120) together do not cover the entire adhesive surface (30) near the opening (60) of the receiving stoma, but rather significantly cover most of that area and thus reduce the risk of contamination of the adhesive surface (30). Figure 3 In this context, these strips (120) have substantially the same width along their entire length, while Figure 4 The bottom portion of the strip is wider, thus covering a larger area of ​​the viscous surface.

[0066] Figure 5 An embodiment of applying the auxiliary member 10 when the base component (70) is pleated is shown. The pleated structure facilitates easy adjustment according to different sizes of the stoma and different shapes and sizes of the openings in the base plate. In the embodiment, the pleated structure (not shown) is replaced by a spiral structure capable of widening or narrowing the base component or a portion thereof.

[0067] Figure 6 The following embodiment is shown: The base member (72, 74) is in the form of a double-layer sheet folded along the peripheral bend line (100) in the bottom portion. The base member has a tab (90) at the neck portion (110). The neck portion (110) is bent or folded into a rounded shape to fit into a hole in the base plate. In the bottom portion (120), shown here in dashed lines, since the bottom portion is covered by the base plate in this view, the folded sheet has been cut into strips (130) to allow these strips (130) to extend radially on the adhesive surface of the base plate. Figure 7 An application aid (10) is shown before being applied to the base plate, and the base member (70) is a folded sheet cut into a slit in the base portion (120).

[0068] While specific embodiments have been shown and described herein, those skilled in the art will understand that various alternatives and / or equivalent implementations may be used instead of the shown and described specific embodiments without departing from the scope of the invention. This application is intended to cover any changes or variations to the body-side components of ostomy appliances as discussed herein. Therefore, the invention is intended to be defined solely by the claims and their equivalents.

Claims

1. An application aid adapted to assist a user in applying an adhesive base plate of an ostomy appliance to a skin surface around a stoma of the user, the adhesive base plate comprising a first adhesive surface facing the skin and a second surface facing away from the skin, the application aid being configured to be removably attached to the base plate and to be adapted to at least partly encircle the stoma of the user during application of the base plate to the skin surface around the stoma of the user, the application aid comprising: a base member comprising a first surface configured to be positioned in a direction away from the peristomal skin and / or away from the stoma and a second surface configured to be positioned in a direction towards the peristomal skin and / or towards the stoma; and a protective member provided on the second surface of the base member and adapted to prevent mucus from a mucosa of the stoma from contaminating the base plate during application of the base plate to the skin surface around the stoma of the user; wherein at least a portion of the first surface of the base member is configured to engage a peripheral edge of an opening in the base plate that receives the stoma.

2. The application aid of claim 1, wherein, The base member comprises a neck portion extending axially outwardly from the peripheral edge of the opening that receives the stoma.

3. The application aid of the preceding claim 1, wherein, The base member comprises a base portion extending radially outwardly from the peripheral edge of the opening that receives the stoma.

4. The application aid of claim 3, wherein, The base portion of the base member extends over a portion of the first adhesive surface of the base plate.

5. The application aid of claim 3, wherein, The distal surface of the base portion comprises a release surface.

6. The application aid of claim 4, wherein, The distal surface of the base portion comprises a release surface.

7. The application aid of any of the preceding claims 1-6, wherein, The base member comprises a tab member for removing the base member.

8. The application aid of any of the preceding claims 1-6, wherein, The base member comprises one or more strips aligned in an axial direction.

9. The application aid of claim 8, wherein, The strips are folded to comprise a double layer.

10. The application aid of claim 1, wherein, The protective member is lined, laminated, sprayed, or sprinkled on the first surface of the base member.

11. The application aid of claim 1, wherein, The protective member comprises an absorbent powder or coating.

12. The application aid of claim 8, wherein, The base portion of the strips is wider than the neck portion.

13. The application aid of claim 9, wherein, The base portion of the strips is wider than the neck portion.

14. The application aid of claim 1, wherein, At least a portion of the base member is pleated.

15. The application aid of claim 3, wherein, The base portion extends over the adhesive surface of the base plate 1-20 mm, measured radially outwardly from the peripheral edge of the opening that receives the stoma.

16. The application aid of claim 1, wherein, The base member is formed of a film material, a foil material, a nonwoven material, a fibrous material, or a paper material.

17. A kit of parts comprising an adhesive base plate and the application aid of claim 1, wherein, The application aid is an accessory member that is combined with the base plate before or during application of the base plate to the skin.

18. A method for preventing contamination of an adhesive surface of an ostomy base plate during application, comprising the steps of: a. providing an application aid according to any of claims 1-16; b. providing an adhesive base plate; c. arranging the application aid on the base plate; d. applying the base plate to a skin surface around a stoma; and e. removing the application aid.

19. A method for preventing contamination of an adhesive surface of an ostomy base plate during application, comprising the steps of: a. providing an application aid according to any of claims 1-16; b. providing an adhesive base plate; c. arranging the application aid on the skin around the stoma; d. applying the bottom plate to the skin such that the opening of the bottom plate fits around the application aid; and e. removing the application aid.

Images