Adhesive stoma fixation components

Abstract

An adhesive stoma fixation component for securing a stoma substrate to the skin. The fixation component includes a flexible, arcuate laminate having a radially inner portion, a radially outer portion, and a proximal adhesive surface for simultaneously securing the laminate to both the patient's skin and the stoma flange. The radially inner portion has a first thickness, and the radially outer portion is patterned with discontinuous areas of a second thickness, the first thickness being less than the second thickness.

Description

[0001] Invention Name

[0002] This invention relates to a fixation component for an adhesive stoma product. Summary of the Invention

[0003] The present invention relates to an adhesive stoma fixation component comprising: a flexible arcuate laminate having a radially inner portion, a radially outer portion, and a proximal adhesive surface for simultaneously fixing the laminate to the ostomy patient's skin and the stoma flange. Attached Figure Description

[0004] The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated in and are 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 become better understood by referring to the following detailed description. Elements of the drawings are not necessarily to scale. The same reference numerals denote corresponding similar portions.

[0005] Figure 1 An embodiment of an adhesive stoma fixation component is shown, viewed from above (far side).

[0006] Figure 2 Another embodiment of the adhesive stoma fixation component, as seen from above, is shown, and

[0007] Figure 3 Showing Figure 2 The embodiment is a cross section along line AA. Detailed Implementation

[0008] In the following text, whenever the proximal side of a device or part thereof is mentioned, it refers to the side facing the skin when the user wears the ostomy apparatus. Similarly, whenever the distal side of a device or part thereof is mentioned, it refers to the side facing away from the skin when the user wears the ostomy apparatus. In other words, the proximal side is the side closest to the user when the apparatus is fitted to the user, and the distal side is the opposite side, the side furthest from the user during use.

[0009] The axial direction is defined as the direction of the stoma when the user wears the device. Therefore, the axial direction is essentially perpendicular to the user's abdominal surface.

[0010] The radial direction is defined as transverse to the axial direction, that is, transverse to the direction of the stoma.

[0011] When measuring the thickness of the laminates described herein, the thickness is the distance from the proximal surface to the distal surface, measured perpendicular to the proximal surface facing the skin. Unless otherwise stated, the thickness is the combined thickness of the backing layer and the adhesive layer.

[0012] This invention relates to an adhesive stoma fixation component, comprising: a flexible arcuate laminate having a radially inner portion, a radially outer portion, and a proximal adhesive surface for simultaneously fixing the laminate to the skin of the ostomy patient and the stoma flange; wherein the radially inner portion has a first thickness, and the radially outer portion is provided with a pattern of discontinuous regions having a second thickness, the first thickness being less than the second thickness.

[0013] The substrate of an ostomy instrument forms a seal around the stoma and prevents leakage against the patient's skin. The patient's body is curved and irregular in shape, meaning it can sometimes be difficult to ensure a tight fit between the substrate and the skin around the stoma. Furthermore, the skin may expand and contract with movement, causing the substrate to stretch and deform during use. This can lead to failure of the seal between the substrate and the patient's skin, resulting in the risk of stoma discharge leakage, spread beneath the substrate, and causing discomfort and embarrassment for the patient.

[0014] To address this issue, fixation members can be used to provide additional protection where needed. Fixation members are typically shaped flexible members, typically formed from a hydrocolloid adhesive laminate, and include an adhesive surface for partial fixation to the patient and partial fixation to a substrate. The semi-circular shape of the fixation member is configured to lie at and overlap the outer edge of the substrate.

[0015] Patterns of discontinuous regions in the form of raised areas with increased thickness can have several advantages. The increased thickness provides a thicker adhesive layer, and thus provides increased absorbency of the adhesive in the outer portion of the component, since the portion of the fixation member is outside the substrate when applied around the substrate of the ostomy device, and is therefore most exposed to moisture from leaks. On the other hand, the inner portion of the fixation member is thinner than the raised areas because the inner portion rests on a substrate where high absorbency is less necessary. Furthermore, the thinner inner portion reduces the combined thickness of the substrate and the fixation member, and thus facilitates a more flexible and less bulky device. A discontinuous region refers to an area of ​​increased thickness, wherein each region is distinguished from others by a region of laminate having a thickness thinner than the discontinuous region's thickness. A pattern of discontinuous regions may include at least two increased thickness regions. In several embodiments, the pattern includes multiple increased thickness regions.

[0016] The raised areas arranged as discontinuous zones provide greater flexibility and stretchability to the fixation member, allowing it to follow body movement without putting pressure on the skin and thus eliminating the risk of detachment between the fixation member and the substrate. Furthermore, the discontinuous zones provide tactile feedback to the user during application as he / she gently pushes to apply additional pressure to the raised areas, thereby promoting better adhesion to the skin.

[0017] In addition, when the adhesive absorbs moisture, it expands, and the raised areas can expand to connect with each other, thus providing the user with tactile differences, allowing the user to feel with his / her fingertips whether and where any leakage may have occurred.

[0018] In several embodiments, discontinuous regions of increased thickness are provided within the adhesive layer and on the distal side of the fastening member, such that the proximal surface of the adhesive layer is generally flat and without bulges. The backing layer may have the same thickness across the entire fastening member and may follow the height variation of the distal surface of the adhesive to provide a raised distal surface of the laminate.

[0019] In several embodiments, the laminate includes a first end portion and a second end portion, wherein the pattern of the raised areas is missing at the end portions. This means that the end portions have equal thickness. In several embodiments, the thickness of the end portions corresponds to the thickness of the inner radial portions. The absence of the raised areas in the end portions is advantageous because, when two or more fixing members are combined around the ostomy substrate, any overlapping end portions will not appear bulky due to the reduced thickness.

[0020] In several embodiments, the first end portion and the second end portion have a third thickness, which is less than the first thickness. The reduced thickness of the end portions is advantageous because when two or more fixing members are combined around the stoma substrate, any overlapping end portions will not appear bulky due to the reduced thickness.

[0021] In several embodiments, the pattern of the discontinuous regions takes the form of radially extending lines or dots with enhanced thickness. This pattern can provide enhanced flexibility and stretchability to the fixed member.

[0022] In several embodiments, the pattern of the discontinuous regions takes the form of longitudinally or arcuate lines with increased thickness. These lines can provide better control over the stretching of the member during application. These lines can follow the arcuate shape of the fixed member, or they can extend longitudinally on the member in a wavy or linear form.

[0023] In several embodiments, the proximal surface includes a hydrocolloid adhesive. The hydrocolloid adhesive is absorbent and capable of absorbing moisture from leaks beneath the substrate.

[0024] In several embodiments, the laminate includes a backing film on a distal surface that does not face the skin. The backing film provides a smooth, non-sticky surface against the user's clothing.

[0025] In several embodiments, the proximal adhesive surface is substantially planar. Such a planar surface can provide a smooth and liquid-tight fit with the skin and substrate, and reduces the risk of channeling beneath the adhesive.

[0026] In several embodiments, the laminate includes a release liner covering the adhesive surface of the laminate. In several embodiments, the release liner includes at least two components. The release liner protects the proximal adhesive surface before application. A release liner having two or more components can facilitate simpler and more precise application of the fixation member because the release liner components can be removed step by step during application. In several embodiments, the release liner includes a radially inner component and a radially outer component. During application, the inner release component is first removed and applied to the substrate, then the outer component of the release liner is removed, and the remaining adhesive surface of the fixation member is applied to the skin.

[0027] In several embodiments, the adhesive-fastening member is beveled along its entire perimeter. The beveled perimeter provides a smooth transition with the surrounding environment and reduces the risk of clothing sticking to the adhesive. In several embodiments, the beveled perimeter of the member has a fourth thickness, which is less than the first thickness.

[0028] When it comes to the thickness of the laminate (hereinafter referred to as the inner radial portion, the outer radial portion, and the raised area for reinforcing thickness), the thickness is measured perpendicular to the skin-facing surface of the laminate, not at the beveled edge. Therefore, the beveled edge portion is not considered part of the raised area for reinforcing thickness.

[0029] In several embodiments, the fixing member spans a central angle of approximately 180 degrees. In several embodiments, the fixing member spans a central angle of approximately 120 degrees, such as 90 degrees or 60 degrees.

[0030] Throughout the laminate, the width of the fixing members is substantially the same. The width is measured as the distance from the inner radial edge to the outer radial edge of the fixing member, taken in the radial direction.

[0031] In several embodiments, the inner radial edge has a constant radius. In several embodiments, the outer radius has a constant radius.

[0032] In several embodiments, the inner radial edge has a constant radius, and the outer radius has a constant radius, such that the inner and outer radial edges are substantially parallel and the width of the fixing member is constant.

[0033] In several embodiments, the end portion of the fixing member may be rounded or have a more square configuration.

[0034] In several embodiments, the adhesive fixing member further includes a first end portion and a second end portion, wherein the end portions have a reduced thickness. The absence of raised patterns on the end portions facilitates overlap of the fixing members, which can occur when two or more members are used to fix a substrate.

[0035] The flexible laminate is a substantially planar laminate having a planar lower surface, wherein the lower surface is the adhesive surface. In other words, the raised portions of the radially outer portion appear in the distal portion of the component, while the proximal portion facing the skin is planar and has no raised portions.

[0036] Detailed description of the attached figures

[0037] Unless otherwise specifically stated, the features of the embodiments described in this application and the various exemplary embodiments may be combined with each other (“mixed and matched”).

[0038] Figure 1 An embodiment of an adhesive stoma fixation component 10, viewed from the distal side, is shown. The fixation component comprises a flexible, arched laminate having a radially inner portion 20, a radially outer portion 30, and two end portions 40. The laminate 10 has an elongated arched shape with two end portions located at each end of the elongated laminate. The laminate includes a proximal adhesive layer 80 having a proximal adhesive surface for simultaneously securing the laminate to both the ostomy patient's skin and the stoma flange. The adhesive layer is covered on the distal surface by a backing layer 90. The inner portion 20 of the distal surface of the laminate is generally flat and has substantially equal thickness, except for optional bevels at the edges (shown as dashed lines 100 in the figure). The outer portion 30 of the distal surface of the laminate is patterned with discontinuous regions 50 separated by intermediate regions 60 of smaller thickness. The thickness of the discontinuous region 50 is greater than the thickness of the inner portion 20. The thickness of the intermediate region 60 may be equal to the thickness of the inner portion 20. In this embodiment, the discontinuous regions 50 define a dot array, which are arranged side by side at the outer portion 30. The discontinuous regions extend to the edge of the outer portion 30 (except for the beveled edge portion 70). The bevel along the edge portion includes an inclined region 100 and a thin peripheral portion 110 of equal thickness, in which the thickness of the laminate gradually decreases, and the peripheral portion 110 is thinner or equal to the thickness of the inner radial portion.

[0039] exist Figure 2Another embodiment of the adhesive stoma fixation member 10, viewed from the distal side, is disclosed. In this embodiment, the discontinuity 50 is in the form of a slightly curved line that is arranged longitudinally following the arcuate shape of the fixation member.

[0040] exist Figure 3 It shows Figure 2 The retaining member has a cross-section along line AA. Along the edge portion 70, the retaining member is beveled by 100° to reduce the risk of adhesive sticking to the user's clothing and causing the member to detach. The thickness of the discontinuity 50 on the outer portion 30 is greater than the thickness of the inner portion 20. In the intermediate portion 60 between the discontinuities 50, the thickness is typically equal to the thickness of the inner portion 20. The thickness-enhancing discontinuities 50 are provided in the adhesive layer 80 and on the distal side of the retaining member, such that the proximal surface of the adhesive layer 80 is generally flat and without bulges. The backing layer 90 has the same thickness throughout the retaining member and follows the height variation of the distal surface of the laminate.

Claims

1. A fixation component for an adhesive stoma product, the adhesive stoma product fixation component comprising: A flexible, bow-shaped laminate having an elongated bow shape with two end portions located at each end of the elongated bow shape, the laminate having a radially inner portion, a radially outer portion, and a proximal adhesive surface for simultaneously securing the laminate to the skin of an ostomy patient and to an ostomy flange; wherein the radially inner portion has a first thickness, and the radially outer portion is provided with a pattern of discontinuous regions having a second thickness, the first thickness being less than the second thickness, wherein the pattern of the discontinuous regions is missing at the two end portions.

2. The fixation component of the adhesive stoma product according to claim 1, wherein, The first end portion and the second end portion of the two end portions have a third thickness, which is less than the first thickness.

3. The fixation component of the adhesive stoma product according to claim 1, wherein, The pattern of the discontinuous region is in the form of radially extending dots or lines with increased thickness.

4. The fixation component of the adhesive stoma product according to claim 1, wherein, The pattern of the discontinuous region is in the form of a line extending longitudinally or in an arc shape with increased thickness.

5. The adhesive stoma fixation component according to claim 1, wherein, The proximal adhesive surface comprises a hydrocolloid adhesive.

6. The adhesive stoma fixation component according to claim 1, wherein, The laminate includes a backing film on the distal-facing surface.

7. The adhesive stoma fixation component according to claim 1, wherein, The proximal adhesive surface is substantially planar.

8. The fixation component of the adhesive stoma product according to claim 1, wherein, The laminate includes a release liner covering the proximal adhesive surface of the laminate.

9. The adhesive stoma fixation component according to claim 8, wherein, The stripper sheet comprises at least two components.

10. The adhesive stoma fixation component according to claim 9, wherein, The stripper includes radially inner components and radially outer components.

11. The fixation component of the adhesive stoma product according to claim 1, wherein, The adhesive ostomy product's fixation component is obliquely cut along its periphery.

12. The fixation component of the adhesive stoma product according to claim 11, wherein, The periphery of the oblique cut of the fixation component of the adhesive stoma product has a fourth thickness, which is less than the first thickness.

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