Ostomy barrier release liner with linear tear film

Abstract

An ostomy barrier for attaching an ostomy appliance to a peristomal skin surrounding a stoma, includes a skin barrier formed from a skin friendly adhesive. The skin barrier has a skin contacting side. A release liner is positioned on the skin contacting side. The release liner is formed from a linear tear film having a direction of tear propagation.

Description

OSTOMY BARRIER RELEASE LINER WITH LINEAR TEAR FILMBACKGROUND

[0001] The following description generally relates to ostomy appliances, and in particular, to an ostomy barrier release liner.

[0002] Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. Two common types of ostomy pouch systems are available, one-piece pouch systems and two- piece pouch systems. In a one-piece pouch system, an ostomy barrier is permanently attached to a pouch and the system is attached to the user by an adhesive on the barrier. In such one-piece pouch systems, the entire pouch system including the ostomy barrier is removed when a user wants to replace the pouch.

[0003] In two-piece pouch systems, a pouch and an ostomy barrier are provided as two separate devices. The two-piece system typically includes a pair of coupling rings, one of which is fixedly attached to the ostomy barrier, and the other of which is fixedly attached to the pouch. The coupling rings mate with each other to securely and removably attach the pouch to the barrier to provide the in-use ostomy pouch system. Two-piece pouch systems allow a user to remove and replace a pouch without removing the ostomy barrier from the user. This can help to reduce the discomfort and irritation associated with removing skin barrier adhesive from the user’s skin.

[0004] Ostomy barriers are configured to seal against peristomal skin surfaces and protect the peristomal surfaces from exposure to stomal effluent. And, the topography of stomas and peristomal surfaces surrounding stomas varies among patients. A person having a stoma that is flush or recessed may find that applying external support or pressure from a barrier in the peristomal region aids in directing the discharge of effluent from the stoma directly into the ostomy pouch.

[0005] As such, barriers may be shaped with a convex domed portion to provide the needed support or pressure to permit properly applying the barrier to the peristomal surface and proper placement of the stoma, while also providing a good seal to prevent effluent egress or leakage from around the stoma / barrier interface.

[0006] As noted above, the barrier has an adhesive to mount the barrier (and the pouch system) to the user. It is important that the adhesive provides a good seal with the peristomal skin. In order to maintain the barrier adhesive in good condition and to prevent contaminants and the like from adhering to the adhesive, the adhesive side of the barrier is provided with a protective release liner.

[0007] Protective release liners are known. Release liners may be formed or applied over the flat portion of the barrier as well as the convex domed portion of the barrier.

[0008] Some release liners are formed from paper or a paper-based material. Paper or paper-based release liners are known that include cuts or perforations to facilitate removing the liner from the barrier. Improvements in release liners include release liners formed from polymeric materials. Some of the polymeric release liners include frangible connections for separating and removing the release liners. Still others include tabs to grip and remove the release liner. Still others are multi-part liners. These multi-part liners facilitate removal of the liner in parts to better protect the adhesive (and the barrier) as it is being positioned on the peristomal skin.

[0009] Issues can arise with removing many of the polymeric liners. For example, these liners may be difficult to remove over the dome or the slope of the dome. In addition, as the liners are removed from the dome, the liner may tear, which can make it very difficult to fully remove the liner without having to handle the barrier adhesive. Small portions of liners that may remain on the adhesive may also be difficult to fully remove, thus compromising the integrity of the barrier seal.

[0010] Accordingly, there is a need for a high-integrity, removable release liner for an ostomy barrier. Desirably, such a release liner can be fully removed from the barrier without leaving portions on the barrier adhesive. More desirably still, such a release liner is easily and cleanly removed from the barrier in sections, to permit the barrier to be applied to the user’s peristomal skin with minimal handling of the adhesive side of the barrier.BRIEF SUMMARY

[0011] In one aspect, an ostomy barrier for attaching an ostomy appliance to a peristomal skin surrounding a stoma includes a skin barrier formed from a skin friendly adhesive, the skin barrier having a skin contacting side. A convex portion is positioned on the skin contacting side. The convex portion has an opening therein for receiving a stoma.

[0012] A release liner is positioned on the skin contacting side and the convex portion. The release liner is formed from a linear tear film having a direction of tear propagation. In embodiments, the linear tear film is an oriented film. The oriented film can be a monoaxially oriented film. In such a film, the direction of tear propagation is parallel to an orientation of the film. In embodiments, the oriented film is one or a combination of polypropylene, polyethylene, and polyethylene terephthalate.

[0013] The release liner can have a tear propagation element formed in the release liner. In embodiments, the tear propagation element is a notch in the release liner on an edge of the linear tear film perpendicular to a direction of orientation of the film.

[0014] The release liner can have tabs to facilitate removing the release liner. The tabs can include two tabs, a first tab on one side of the tear propagation element and a second tab on another side of the tear propagation element.

[0015] In embodiments, the tear propagation element is a first tear propagation element and the release liner further includes a second tear propagation element. In such embodiments, one or both of the first and second tear propagation elements are notches in the release liner on a same edge of the release liner perpendicular to a direction of orientation of the film. The notches define a central portion and first and second side portions of the release liner. One, two or all of the central portion, first side section and second side section can include a tab. The notches can be formed on the same edge or opposing edges of the release liner perpendicular to a direction of orientation of the film.

[0016] In embodiments, the release liner includes a release coating thereon, on a side facing the skin contacting side. The release coating can be, for example, a silicone coating.

[0017] In another aspect, a method of forming an ostomy barrier includes providing a skin barrier formed from a skin friendly adhesive, the skin barrier having a skin contacting side, and a convex portion on the skin contacting side. The convex portion has an opening therein for receiving a stoma.

[0018] The method further includes applying a release liner on the skin contacting side and the convex portion. The release liner is formed from a linear tear fdm having a direction of tear propagation. The method can include forming a tear propagation element in the release liner in an edge perpendicular to the direction of tear propagation. Forming the tear propagation element can be forming a first tear propagation element and the method can include forming a second tear propagation element in the release liner in the edge perpendicular to the direction of tear propagation.

[0019] In methods, forming the tear propagation element is forming a first tear propagation element and further includes forming a second tear propagation element in the release liner in an opposing edge perpendicular to the direction of tear propagation.

[0020] The method may further include forming one or more tabs on the release liner. The method can further include removing the portion of the liner that overlies the stoma receiving opening.

[0021] Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings, and wherein like numerals may refer to like parts, elements, components, steps, and processes.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0023] FIG. l is a side view of a convex ostomy barrier including an embodiment of a release liner with a linear tear film;

[0024] FIG. 1A is an enlarged, exploded schematic view of the circled area in FIG. 1;

[0025] FIG. 2 is a top view of the barrier with the release liner with linear tear film of FIG. 1 ;

[0026] FIG. 3 is a front perspective view of the barrier with the release liner with linear tear film of FIG. 1;

[0027] FIG. 4 is a rear perspective view of the barrier with the release liner with linear tear film of FIG. 1;

[0028] FIG. 5 is a side view of a convex ostomy barrier including another embodiment of a release liner with the release liner with linear tear film;

[0029] FIG. 5A is an enlarged, exploded schematic view of the circled area in FIG. 5;

[0030] FIG. 6 is a top view of the barrier with the release liner with linear tear film of FIG. 5;

[0031] FIGS. 7 and 8 are front perspective views of the barrier with the release liner with linear tear film of FIG. 5;

[0032] FIG. 9 illustrates the barrier of FIG. 5 with the central portion of the release liner with linear tear film removed;

[0033] FIG. 10 illustrates the barrier of FIG. 5 with the central portion and one side portion of the release liner with linear tear film removed; and

[0034] FIG. 11 illustrates the barrier of FIG. 5 with a central portion and both side portions of the release liner with linear tear film removed.DETAILED DESCRIPTION

[0035] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered illustrative only and is not intended to limit the disclosure to the specific embodiments described or illustrated.

[0036] Referring to FIGS. 1-4, there is shown an embodiment of an ostomy barrier 10 having a release liner 12 formed with a linear tear film 14. The barrier 10 includes a skin barrier 16, which in the illustrated barrier 10 has a flat square shape,and a centrally located convex domed portion 18 having an opening 20 for receipt of a stoma (not shown). As illustrated in FIG. 1, the user-facing side (indicated at 22) is positioned such that the convex domed portion 18 applies a force on the peristomal skin so that the stoma extends into and / or through the opening 20. It will be appreciated that this side (the user facing side 22) of the barrier 10 has the adhesive A and the release liner 12 with linear tear film 14 applied over the adhesive A. The convex domed portion 18 may be formed by a convex insert. It is anticipated that the portion of the liner 12 that overlies the opening 20 is removed during manufacture. The ostomy barrier 10 is illustrated as a convex ostomy barrier in the embodiment shown in FIGS. 1-4. In other embodiments, the ostomy barrier 10 may be a generally flat barrier without a convex domed portion.

[0037] In embodiments, the release liner 12, which is formed with the linear tear film 14, can include a coating 24 thereon to facilitate easy release from the adhesive A. The release coating or layer 24 can be, for example, a silicone layer 24 on the release film 12 on the side facing the adhesive A.

[0038] One suitable linear tear film 14 is a monoaxially oriented film. Such films are oriented, for example, during the extrusion process or as a secondary process, by stretching in one direction. Stretching can be in the cross direction or the machine direction. It will be understood by those skilled in the art that monoaxial orientation is the orientation of plastic films by stretching in one direction only. That is, the long polymer chains that make up the film 14 are oriented in the direction of stretch. These films 14 are generally stronger and stiffer, but have very poor tear strength (i.e., are more easily torn) in the direction of orientation O. Poor tear strength in the orientation direction O allows for a linear tear or near linear tear in the release liner 12. Some suitable film 14 materials include polypropylene (PP), polyethylene (PE), and polyethylene terephthalate (PET). Other suitable materials will be recognized by those skilled in the art.

[0039] Referring now to FIGS. 2-4, there is shown an ostomy barrier 10 including an embodiment of a partial tear part release liner 12 with a linear tear film 14, having a tear propagation element 28 formed in the release liner 12. In embodiments, described herein, the tear propagation element 28 is a notch 30 formed in the liner 12. Inthe partial tear liner 12, the notch 30 can be formed at about a mid-point of the barrier 10. The notch 30 may be configured to initiate and propagate a tear T in the direction of orientation O. In an embodiment, the notch 30 may be formed in an edge 32 of the liner 12, which is perpendicular to the direction of the film orientation O, or more specifically, in an edge 32 of the film 14 perpendicular to the direction of orientation O of the polymer chains of the film. That is, the notch 32 may be formed in a direction parallel to the direction of orientation O (that is, aligned with the direction of orientation O) and configured to facilitate the tear T in the direction of orientation O.

[0040] The notch 30 influences the tear T in the direction of orientation O such that the film tear T propagates in a straight or generally straight line, or linearly from the notch 30. Such tear T propagation facilitates readily removing the liner 12 over the convex domed region 18 (over the dome). It will be appreciated by those skilled in the art that the linear tear film 14 has significantly more strength in the direction perpendicular P to the film orientation O. As such, the tear T will be straight or generally straight in the orientation direction O and there is little likelihood that the tear T will waiver or fracture.

[0041] To further facilitate removing the liner 12, the liner 12 can include tabs 34a, 34b on either side of the notch 30 for grasping and pulling the liner 12 to begin the tear T, and / or to remove or peel the liner portion 12 from the barrier 10. In this manner, the user can begin the tear T at the notch 30, and continue the tear T to the opening 20. A portion of the liner (for example, portion 12a) can be removed from the barrier 10 and that area of the barrier 10 positioned on the peristomal area (and smoothed out). Once that portion of the barrier 10 is properly positioned and smoothed out, the user can continue the peel of the release liner 12 around the other side of the barrier 10 to peel portion 12b, and secure the barrier 10 to the peristomal skin. This reduces the need to handle the barrier 10 and more specifically the need to handle the adhesive A side of the barrier 10. That is, the release liner 12 with linear tear film 14 provides the user with a non-adhesive area to handle or grip while placing the barrier 10 around the stoma.

[0042] It will be appreciated that with such a monoaxially oriented film, starting the tear at notch 30 grasping and pulling tab 34a to remove liner portion 12a, once the tear T reaches the opening 20, where the liner 12 has been removed, the “peel”of the liner 12 will continue over and around the domed region 18 and will then peel along and remove the opposite side 12b of the liner 12.

[0043] Referring now to FIGS. 5-11, there is shown another embodiment of an ostomy barrier 110 having a release liner 112 with a linear tear film 114. Although the ostomy barrier 110 is shown as a convex ostomy barrier in FIGS. 5-11, the release liner 112 can also be used for generally flat ostomy barriers. This embodiment of the liner 112 is a three-part liner having a central portion 112a and first and second side portions 112b, 112c. As with the barrier 10 of FIGS. 1-4, this barrier 110 also includes a skin barrier 116, which in the illustrated barrier 110 has a flat round shape, and a centrally located convex domed portion 18 having an opening 20 for receiving a stoma.

[0044] Also as with the barrier 10 of FIGS. 1-4, the adhesive A, and the release liner 112 with linear tear film 114 applied over the adhesive A, is on the convex domed portion 18 side of the barrier 110. And, the release liner 112 includes the linear tear film 114, such as the monoaxially oriented film and a release coating 24, such as silicone, to facilitate release from the adhesive A.

[0045] This embodiment of the liner 112 includes two notches, one notch 130a formed between the central portion 112a and the first side section 112b and the other notch 130b formed between the central portion 112a and the second side section 112c. The notches 130a, 130b are formed in an edge 32 that is perpendicular to direction of the film orientation O. The notches 130a, 130b influence the tears T in the direction of orientation O such that the film tears T propagate in straight or generally straight lines, or linearly from the notches 130a, 130b. And, as with the embodiment 12 of FIGS. 1-4, this embodiment of the liner 112 can include tabs 134a, 134b, 134c at the central 112a and side portions 112b, 112c to facilitate grasping the liner portion to facilitate the tears T.

[0046] With this embodiment 110, the user can remove the liner central portion 112a and position the barrier 110 on the peristomal area to properly position the barrier 110 relative to the stoma. Once the barrier 110 is positioned, the user can then remove one of the liner side sections (for example, 112b), secure that region of the barrier 110 while still having the other side portion with the liner 112c intact, to hold on to. Once the first side portion is secure, the user can remove the liner second portion 112c and secure that region of the barrier 110. This configuration likewise reduces the need tohandle the barrier 110 and more specifically the need to handle the adhesive A side of the barrier 110, and provides the user with non-adhesive areas to handle or grip while placing the barrier 110 around the stoma.

[0047] It will also be appreciated that in either embodiment of the barrier / liner 10, 110 / 12,112, the notch 30 or notches 130 need not be exactly centered or exactly symmetrical relative to each other in that the tear or tears T will propagate in the direction of orientation O of the film 14. 114. Rather the notches 30, 130 need only be formed perpendicular to the edge 32 of the liner 12, 112 and in a direction parallel to (or aligned with) the film orientation O.

[0048] In a method of forming a barrier 10, 110 with the release liner 12, 112 with a linear tear film 14, 114, a roll of material is oriented such that the release liner 12, 112, when placed on the barrier adhesive A, is positioned such that the monoaxial orientation of the film 14, 114 is aligned with the notch or notches 30, 130 and the location at which tear line or tear lines T are desired to be created in the liner 12, 112. In methods, the release liner 12, 112 is thermoformed onto the skin barrier 16 and convex domed position 18.

[0049] All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure. In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0050] In addition, it is to be understood that terminology referring to directions or relative orientations, such as, but not limited to, “upper” “lower” “raised” “lowered” “top” “bottom” “above” “below” “alongside” “left” and “right” are used for purposes of example and do not limit the scope of the subject matter described herein to such orientations or relative positioning.

[0051] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present invention. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should beinferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMSWhat is claimed is:

1. An ostomy barrier for attaching an ostomy appliance to a peristomal skin surrounding a stoma, the ostomy barrier comprising: a skin barrier formed from a skin friendly adhesive, the skin barrier having a skin contacting side; an inlet opening for receiving a stoma; and a release liner positioned on the skin contacting side, the release liner formed from a linear tear film having a direction of tear propagation.

2. The ostomy barrier of claim 1, wherein the linear tear film is an oriented film.

3. The ostomy barrier of claim 2, wherein the oriented film is a monoaxially oriented film.

4. The ostomy barrier of claim 2 or 3, wherein the direction of tear propagation is parallel to an orientation of the film.

5. The ostomy barrier of any one of claims 2-4, wherein the oriented film is one or a combination of polypropylene, polyethylene, and polyethylene terephthalate.

6. The ostomy barrier of any preceding claim having a tear propagation element formed in the release liner.

7. The ostomy barrier of claim 6, wherein the tear propagation element is a notch in the release liner on an edge of the linear tear film, wherein the edge is perpendicular to a direction of orientation of the film.

8. The ostomy barrier of claim 7, further including two tabs, a first tab on one side of the tear propagation element and a second tab on another side of the tear propagation element.

9. The ostomy barrier of any one of claims 6-8 wherein the tear propagation element is a first tear propagation element and further including a second tear propagation element.

10. The ostomy barrier of claim 9, wherein one or both of the first and second tear propagation elements are notches in the release liner on a same edge of the release liner, wherein in the edge is perpendicular to a direction of orientation of the film.

11. The ostomy barrier of claim 10, wherein the notches define a central portion and first and second side portions.

12. The ostomy barrier of claim 11, wherein one, two or all of the central portion, first side section and second side section include a tab.

13. The ostomy barrier of claim 10, wherein the notches are formed on opposing edges of the release liner, wherein each of the opposing edges is perpendicular to a direction of orientation of the film.

14. The ostomy barrier of any one of claims 1-13, wherein the release liner includes a release coating thereon on a side facing the skin contacting side.

15. The ostomy barrier of claim 14, wherein the release coating is a silicone coating.

16. The ostomy barrier of any one of claim 1-15, wherein the ostomy barrier is a convex ostomy barrier including a convex portion on the skin contacting side, whereinthe inlet opening is defined in the convex portion, and wherein the release liner is positioned on the skin contacting side and the convex portion.

17. A method of forming an ostomy barrier, comprising: providing a skin barrier formed from a skin friendly adhesive, the skin barrier having a skin contacting side; and applying a release liner on the skin contacting side, the release liner formed from a linear tear film having a direction of tear propagation.

18. The method of claim 17 including forming a tear propagation element in the release liner in an edge that is perpendicular to the direction of tear propagation.

19. The method of claim 18, wherein the tear propagation element is a first tear propagation element and including forming a second tear propagation element in the release liner in the edge that is perpendicular to the direction of tear propagation.

20. The method of claim 18, wherein the tear propagation element is a first tear propagation element and including forming a second tear propagation element in the release liner in an opposing edge that is perpendicular to the direction of tear propagation.

21. The method of any one of claims 16-19 including forming one or more tabs on the release liner.

22. The method of any one of claims 16-20 further including removing a portion of the release liner overlying the stoma receiving opening.

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