Multifunctional release liner for dressings

Abstract

A dressing is described having a backing layer, an (absorbent) pad, an adhesive coating and a release liner. The release liner is releasably attached to the adhesive coating. The release liner is configured to stiffen up and protect protrusions and/or border portions of the dressing that may otherwise be wrinkled, folded, kinked or otherwise damaged or impaired prior to (transportation or storage) or during application at the point-of-use. The dressing can be used for wound treatment. The dressing can prevent shearing and/or friction from causing (deep tissue) skin damage.

Claims

1. A dressing having a maximum lateral (X2) and a maximum longitudinal (Y2) extension; wherein said dressing has at least one protrusion, wherein said at least one protrusion has a lateral (X1) or a longitudinal (Y1) extension, or both, that is less than 50% of the maximum lateral (X2) or the maximum longitudinal (Y2) extension, or both, of the dressing; wherein said dressing has a first side and a second opposing side, the first side comprising an adhesive coating having a skin-facing surface adapted to detachably adhere the dressing to a dermal surface, wherein the dressing comprises a release liner comprising a first portion and a second portion configured to be removed separately, wherein said first portion and said second portion are releasably attached to the adhesive coating; wherein said first portion of said release liner covers at least a part of an area of said at least one protrusion, and a part of an area outside of said at least one protrusion, wherein a thickness or stiffness, or both, of said first portion of the release liner is higher than a thickness or stiffness, or both, of said second portion of said release liner, wherein said thickness or stiffness, or both, of said first portion and said second portion, respectively, are measured in an unfolded area thereof.

2. The dressing according to claim 1, wherein said dressing further comprises a backing layer; a pad contoured by a pair of lateral edges, wherein said lateral edges extend essentially in parallel to each other in the longitudinal direction, and contoured by a pair of longitudinal edges, wherein said longitudinal edges extend essentially in parallel to each other in the lateral direction; wherein said pad is arranged between said backing layer and said adhesive layer.

3. The dressing according to claim 2, wherein said backing layer extends beyond the periphery of said pad to define a border portion along at least a part of a contour of said pad.

4. The dressing according to claim 3, wherein at least a part of the border portion defines at least a part of a protrusion.

5. The dressing according to claim 3, wherein a maximum distance d1 between a lateral or a longitudinal edge of at least one protrusion to a closest edge of said pad, in particular from the outer edge of said protrusion to the outer edge of said pad is from 10 mm to 80 mm.

6. The dressing according to claim 1, wherein the dressing has only one axis of symmetry or has no axis of symmetry.

7. The dressing according to claim 6, wherein the dressing has one axis of symmetry, wherein said symmetry axis also encompasses said at least one protrusion, wherein said symmetry axis also encompasses said part of the area outside of said at least one protrusion that is also of said higher thickness or stiffness, or both.

8. The dressing according to claim 1, wherein the thickness of the release liner in the first portion is in the range of from 50 ?m to 1000 ?m, and wherein the thickness of the release liner in the second portion is lower than in the first portion, and is in the range of from 10 ?m to 500 ?m.

9. The dressing according to claim 1, wherein the release liner has an increased thickness in the first portion relative to the second portion, wherein the increased thickness of the release liner in the first portion is greater by at least 25% than the thickness of the release liner in the second portion.

10. The dressing according to claim 1, wherein the release liner has an increased stiffness in the first portion relative to the second portion, wherein the increased stiffness of the release liner in the first portion, as defined by a load at material deformation in said area of said at least one protrusion and in said part of the area outside of said at least one protrusion is from 25 N to 150 N, wherein the stiffness of the release liner in said second portion is from 10 N to 60 N, as measured according to ASTM D882-12.

11. The dressing according to claim 1, wherein the release liner has an increased stiffness in the first portion relative to the second portion, wherein the stiffness of the release liner, defined by a load at material deformation in said area of said at least one protrusion and in said part of said area outside of said at least one protrusion, is greater by at least 25% than the stiffness of the release liner in said second portion, wherein said stiffness is measured according to ASTM D882-12.

12. The dressing according to claim 1, wherein at least one protrusion has a lateral (X1) extension or a longitudinal (Y1) extension of 30% or less of the maximum lateral (X2) or of the maximum longitudinal (Y2) extension, or of both, of the overall dressing.

13. The dressing according to claim 1, wherein said dressing is a dressing for application to a contoured body part, in particular the sacrum, heel, elbow, knee and the like.

14. The dressing according to claim 1, wherein the dressing comprises at least one gripping tab.

15. A method comprising a step of applying the dressing of claim 1 to a wound, thereby treating the wound.

16. The dressing according to claim 1, wherein the release liner further comprises a third portion being releasably attached to the adhesive coating, wherein the third portion is separate from the first portion and the second portion, wherein the thickness or stiffness, or both, of the release liner is increased in the first portion relative to a thickness or stiffness, or both, of the third portion, wherein said thickness or stiffness, or both, of said first portion and said second portion, respectively, are measured in an unfolded area thereof, wherein the first portion is a central portion arranged between the second portion and the third portion along an axis of the dressing.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows two commercially available dressings for application on a contoured body part, in particular the heel (FIG. 1a) and the sacrum (FIG. 1b).

(2) FIG. 2 illustrates the dressing of FIG. 1a, wherein the central release liner is peeled off.

(3) FIG. 3 shows a dressing suitable for the sacrum that has one axis of symmetry and a w-shaped protrusion at the bottom end.

(4) FIG. 4 shows an embodiment in accordance with the present invention: the central area of a three-part release liner is of increased thickness and/or of increased stiffness and covers and stiffens up the bottom protrusion.

(5) FIG. 5 shows a dressing according to one exemplary embodiment of the invention.

DETAILED DESCRIPTION

(6) The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which currently preferred embodiments of the present invention are shown. The present invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness, and to more fully convey the scope of the present invention to the skilled person.

(7) The adhesive used in the adhesive coating is preferably skin-friendly and sufficiently adherent to skin such that the dressing stays in place, and maintains its adherence with repeated removal and re-application. The adhesive should be easy to remove without causing trauma.

(8) In embodiments of the invention the adhesive comprises a silicone gel, preferably a soft silicone gel. Examples of suitable silicone gels include the two component RTV systems, such as Q72218 (Dow Corning), and SilGel 612 (Wacker Chemie AG), as well as NuSil silicone elastomers.

(9) In embodiments of the present invention, the adhesive layer of the dressing covers at least 50% of the surface of the pad, preferably at least 60%, further preferably at least 70% of the pad. This ensures or at least facilitates the overall dressing to sufficiently adhere to the skin of a patient during use.

(10) The adhesive layer may be perforated or non-perforated.

(11) In embodiments of the present invention, the adhesive layer may be configured to be a body contact layer As used herein, the term body contact layer means the layer that is in contact with the skin of a wearer.

(12) In the field of medical dressings, in particular, wound dressings, a film provided with an adhesive layer for adhering to the patient is often referred to as a wound contact layer. The dressing of the invention may be used on a human body area which has no wound, and therefore the combined film and adhesive layer will be referred to as a body contact layer.

(13) The film onto which the adhesive layer is applied in such a body/wound contact layer may be comprised of a thin plastic film, or a laminate comprising a thin plastic film. Suitable materials for the film include, but are not limited to breathable polyolefin based films (such as polyethylene), polyamide, polyester polyurethane, and silicone. A suitable material for use as the film is a thin polyurethane film. For example, the film of the body contact layer may be a polyurethane film having a thickness of from 15 and 100 ?m, e.g. from 40 to 80 ?m, preferably from 45 to 60 ?m.

(14) As already discussed above, in embodiments of the present invention, the dressing comprises a border portion [see, e.g. (102 and 102) in FIG. 1a/1b or (302) in FIG. 3]. In embodiments, at least the backing layer extends beyond the periphery of the (absorbent) pad to define a border portion around the contour of the pad, or also only parts of the pad. In FIG. 1, the backing layer and the adhesive layer extend beyond the periphery of the pad to define a border portion around the contour of the pad.

(15) The adhesive layer is preferably co-extensive with the backing layer, and has the same outer dimensions (lateral and longitudinal extension, including all protrusions).

(16) In embodiments of the invention, and in particular in order to achieve sufficient adhesion properties, the border portion has a width of 5 to 60 mm and extends along at least parts of the contour of the pad, preferably along the entire pad.

(17) A smaller sized dressing may have a smaller border portion than a larger sized dressing.

(18) In embodiments of the invention, the dressing as such and hence if present, the corresponding border portion, may be substantially heart shaped such that a first and a second lobed portion form part of the lobed upper sides of a heart shape (see FIG. 3). The dressing has an axis of symmetry (304), a maximum lateral extension X2 and a maximum longitudinal extension Y2.

(19) In this illustrative embodiment, the dressing is symmetric about a longitudinal center line (304) and comprises a first lobed portion (305) one side of the longitudinal center line (304), and a second lobed portion (306) on the other side of the longitudinal center line. The first and second lobed portions (305 and 306) are separated by a forked portion (w-portion) (307) which replaces the pointed lower part of a heart shape. The forked portion (307) as such is a protrusion or may be seen as comprising a protrusion on either side of an interstice located coaxially with the longitudinal center line. Either way, this protrusion or these two protrusions are advantageously protected from wrinkling or kinking by incorporating a reinforced (increased thickness or stiffness or both) part of the release liner, in accordance with the present invention.

(20) As used herein, the term lobed portion means a curved or rounded portion of the dressing. In embodiments, the tab projects outwardly from the border portion. In this connection it should be understood that inwardly means a direction towards the inner perimeter of the border area, i.e. a direction towards the pad, while outwardly is an opposite direction.

(21) The dressing has a border region (302) and a pad (301), as well as gripping tabs (308) and (309). The shape of this preferred dressing is adapted to fit to the sacral region of a human body. The forked portion allows for improved stay-on ability in the gluteal cleft region. It is important that this kind of dressing remains adhered in this region since otherwise body fluids (for example as a result of incontinence) may enter into the dressing and impair the adhesion to the skin.

(22) The maximum extension of the protrusion in the lateral (x) direction, X1, is from 10% to 40% of the maximum extension X2, of the overall dressing in the lateral (x) direction.

(23) The maximum extension X2 of such a preferred sacrum dressing is typically in the range of from 12 to 30 cm, preferably from 15 to 20 cm. The maximum extension X1 of the protrusion is preferably in the range of from 2 to 10 cm, e.g. from 4 to 7 cm, depending on the size of the dressing.

(24) In embodiments of the present invention, the pad is arranged to taper downwards, towards the lower region and has a more narrow width in the lower region of the dressing. This shape of the pad allows for proper protection of the coccyx, which is a bony prominence at risk for the development of pressure ulcers. Such a pad also conforms well to the body in the gluteal cleft region. As illustrated in FIG. 3, this part of the pad (301) may also be part of the protrusion (303) and therefore also aid in increasing the stability/stiffness of said protrusion, preferably together with a reinforced release liner. In embodiments of the present invention, the pad is absorbent. The pad may be comprised of one layer or of a plurality of layers.

(25) In embodiments of the present invention, the backing layer of the overall dressing is a thin film, sheet or membrane that is vapor permeable and waterproof. Examples of suitable materials for the backing layer include, but are not limited to polyurethane, polyethylene or polyamide films, silicone films, polyester based nonwoven materials, and laminates of polyester-based nonwoven materials and polyurethane films.

(26) In embodiments of the invention, the backing layer is a polyurethane film and preferably has a thickness of from 5 to 40 ?m, e.g. from 15 to 25 ?m.

(27) The backing layer may be partly or fully bonded to the pad, for example, via an adhesive such as a pressure sensitive adhesive (e.g. an acrylic adhesive).

(28) In embodiments, the dressing comprises at least one gripping tab; the gripping tab preferably being coplanar with and projecting outwardly from the periphery of the dressing [see (308) and (309) in FIG. 3].

(29) The gripping tab guides the caregiver to lift the dressing, inspect the skin underneath the dressing, and to thereafter re-apply the dressing onto the skin (in case the skin looks ok). Inspection of skin may still be required, albeit on a less frequent basis when the dressing is transparent.

(30) In embodiments, the gripping tab is made in one piece with and projecting outwardly from the border. The gripping tab may be made of the same materials as the border portion, e.g. it may be made from the backing layer and the body contact layer. Hence, the border portion may extend uninterrupted from the border to the gripping tab. This may be beneficial from a manufacturing perspective. However, in at least some exemplary embodiments the gripping tab may be made from a different (or same) material and attached to the border portion.

(31) Since the inspection of the skin typically takes place where the patient is lying on the side in the bed, in preferred embodiments that apply for a sacrum dressing in particular, the dressing comprises at least two gripping tabs such that the caregiver can lift the dressing regardless of which side the patient lies. Hence, in embodiments, the gripping tab is a first gripping tab, and the dressing further comprises a second gripping tab that is coplanar with and projects outwardly from the second lobed portion.

(32) As best illustrated in FIG. 4, the dressing may be divided into three separate zones along the longitudinal (y) extension of the dressing: one central zone (410) and two lateral zones (411 and 412), preferably wherein the central part of the release liner is the reinforced part of the release liner, i.e. is of increased thickness or stiffness, or both (see hatched area). As mentioned hereinbefore, the release liner covering the central zone (410) of the dressing is preferably removed first. The release liners (411 and 412) are preferably thinner and/or less stiff than the central part. In order to facilitate smooth application of the dressing onto the skin of a patient.

(33) Referring back to FIG. 2, illustrating a heel dressing, the central release liner (212a) is preferably removed first. Subsequently, the remaining release liner portions (212b-212e) are removed and the dressing is gently applied to the body of a patient. In the embodiment illustrated in FIG. 2, the central part of the release liner (212a) may be the stiff and/or thick release liner portion (as long as it provides sufficient coverage and protection of the protrusions). Alternatively, the release liner portions 212b-212e are stiffer and/or thicker than the central portion (212a).

(34) The characteristic dimensions of an exemplary dressing are further exemplified in FIG. 5, showing the bottom view of a sacrum dressing having a pad (501) and a border portion (502). Protrusion (P) comprising the w-shaped extension (506) is separated by an (imaginary) dotted line from the remaining area (RA). As can be seen from this exemplary embodiment, the protrusion comprises the w-shaped part of the border portion, but also the narrow part of the pad. In this embodiment, the reinforced release liner (509, hatched area) not only covers the entire protrusion, but also a significant part of the remaining area, thus stabilizing the protrusion.

(35) Measurement of the Release Liner Stiffness (Standard: ASTM D882-12)

(36) Test specimens for a release liner having a width of 25 mm and a length of 150 mm were punched out from two different polyethylene films: one having a thickness of 100 ?m and a basis weight of 92 g/m.sup.2 (sample A) and one having a thickness of 200 ?m and a basis weight of 184 g/m.sup.2 (sample B). A tensile tester (Insight MTS) was used to determine the elastic modulus and the peak load at deformation of the materials. The tensile tester was calibrated according to the apparatus (tensile tester: Insight, supplier MTS, year 2008) instructions and set to zero. The samples were mounted in the clamps and the test speed was set to 50 mm/min. The gauge length was 80 mm.

(37) The tensile tester was started and the samples were elongated until break or until reaching 100% elongation. Measurements resulting from premature failures (i.e. the sample breaking at the clamp, or becoming damaged during preparation) were ignored.

(38) The tensile force and elongation were measured during the entire test, and the following results were obtained from the measurements: Peak load (N)the maximal load recorded during the test Strain at peak load (%) Young's modulus at 10% strain was obtained by the following formula: E.sub.10%=Stress at 10% strain/0.1 (the calculations were based on data points before deformation of the material had begun; i.e. before data plot becomes linear)

(39) The results are summarized in table 1 below.

(40) TABLE-US-00001 Peak load at Young's Modulus at Sample deformation (N) 10% strain (kPa) Sample A 23.0 85.1 Sample B 50.2 93.8