Multifunctional release liner for dressings
The dressing with reinforced release liners addresses wrinkling issues by stabilizing protrusions, ensuring effective adhesion and preventing fluid accumulation on contoured body areas.
Patent Information
- Application Number
- JP2020563469
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-05-30
- Filing Date
- 2019-05-28
- Publication Date
- 2025-11-11
- Estimated Expiration
- 2039-05-28
AI Technical Summary
Dressings with protrusions are prone to wrinkling, folding, or twisting during storage and application, compromising their stay-on ability and potentially leading to fluid accumulation due to reduced stability and flexibility.
A dressing design with protrusions having elongations less than 50% of the maximum, featuring a release liner with increased thickness or stiffness over the protrusions and adjacent areas, ensuring stability and protection against wrinkling.
The design enhances the dressing's stability and adhesion, preventing wrinkles and fluid accumulation, maintaining effective application and adhesion to contoured body areas.
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Abstract
Description
[Technical Field]
[0001] The present invention relates to a dressing comprising a backing layer, a pad, an adhesive coating, and a release liner releasably attached to the adhesive coating, the release liner configured to stiffen and protect protruding portions and / or edge portions of the dressing that may otherwise be wrinkled, creased, twisted, or otherwise damaged or compromised, for example, during shipping or storage, or during application at the point of use.
[0002] The dressings of the present invention are suitable for wound treatment and wound prevention, particularly for wound prevention, and more particularly for application to contoured body areas. [Background technology]
[0003] Dressings of various sizes and shapes with more elaborate release liners are known in the art, particularly from, for example, U.S. Patent Nos. 5,629,999, 5,729,929, 5,739,947, 5,749,963, or 5,829,092 (all assigned to Molnlycke Health Care), which protect the dressing from contamination prior to use and may also improve the functionality and durability of the dressing during use by facilitating application of the dressing.
[0004] Patent Documents 2 and 3 disclose dressings adapted to be applied to contoured body parts, particularly the sacrum and heels, respectively. These dressings are suitable for preventing pressure sores. These types of dressings may be relatively large and may have protrusions, i.e., areas extending beyond the characteristic extension of the entire dressing, such as the edge regions at the edges of such dressings.
[0005] The stability issues that can arise with such dressings having one or more protrusions are perhaps best illustrated in Figure 1, which shows two commercially available dressings for application to contoured body parts, specifically the heel (Figure 1a) and sacrum (Figure 1b). For example, protrusions (103a, 103a') and protrusions (103b, 104b') of the thinner end regions (102, 102') extend beyond the thicker pads (101, 101') by a distance d1'.
[0006] Typically, each dressing is packaged in an individual pack, and then multiple individually packaged dressings are packaged in a larger package, such as a carton box. During storage and transportation, the protrusions may fold or wrinkle when pressed against the inner surface of the individual pack. In addition to compromising the visual appearance of the dressing when removed from the package, the formation of such folds or wrinkles may affect the stay-on ability of the dressing. There is a risk that the wrinkles that form may become compartments for bodily fluids, resulting in fluid accumulation and reduced stay-on ability. These potential problems may be more severe for larger dressings and / or dressings with relatively limited inherent stiffness, for example, because those dressings need to be thin or relatively flexible.
[0007] Even if such "flexible" dressings or dressings with pliable portions are temporarily protected and supported by rigid or otherwise specially designed packaging, the dressing must eventually be removed from the packaging, handled by the patient or caregiver, and ultimately applied, which again can cause the dressing to wrinkle, roll, twist, or otherwise become damaged during the application process (i.e., before all release liners have been removed and the dressing is securely placed on the patient). [Prior art documents] [Patent documents]
[0008] [Patent Document 1] International Publication No. 2017 / 081012 [Patent Document 2] International Publication No. 2017 / 220401 [Patent Document 3] International Publication No. 2017 / 220402 Summary of the Invention [Problem to be solved by the invention]
[0009] Accordingly, one object underlying the present application is to provide a dressing having protrusions, which avoids or mitigates the problems associated with such dressings as outlined above. [Means for solving the problem]
[0010] These and other problems are at least partially solved by a dressing having a maximum transverse (X2) (i.e., "sideways") and a maximum longitudinal (Y2) (i.e., perpendicular to the "sideways" elongation and preferably along an axis of symmetry) elongation; said dressing having at least one protrusion, said protrusion having a transverse (X1) or longitudinal (Y1) elongation, or both, that is less than 50% of said maximum transverse (X2) or maximum longitudinal (Y2) elongation, or both, of the entire dressing; the dressing has a first side and a second opposite side, the first side including an adhesive coating having a skin-facing surface adapted to releasably adhere the dressing to a skin surface; the dressing includes a release liner releasably attached to the adhesive coating; the release liner has areas of increased thickness or increased stiffness, or both, over at least a portion of the area of the at least one protrusion and over a portion of the area outside the at least one protrusion (but not over the entire area outside the at least one protrusion); The increased thickness or increased stiffness, or both, is measured relative to the thickness or stiffness, or both, of the release liner in the remaining area, i.e., the area where the release liner is not reinforced in terms of thickness and / or stiffness (this is the "remaining area").
[0011] In embodiments, the dressing comprises: Backing layer and a pad, the pad being contoured by a pair of lateral edges, preferably extending substantially parallel to one another in a longitudinal direction, and a pad being contoured by a pair of longitudinal edges, preferably extending substantially parallel to one another in a transverse direction; Including, The pad is disposed between the backing layer and the adhesive layer.
[0012] According to the present invention, a "protrusion" is a segment of a dressing that extends beyond the central area of the dressing and is characterized by a (maximum) lateral and longitudinal extension of less than or equal to 50% of the (maximum) lateral and longitudinal extension, respectively, of the entire dressing. Examples of protrusions are segment (103a / 103a') in Figures 1a / 1b, segment 203 in Figure 2, or segment (303) in Figure 3.
[0013] A portion of the profile of the protrusion is defined by and coincides with the outer contour of the entire dressing, while the remainder of the protrusion is defined by an imaginary line separating the remaining area of the dressing from the protrusion. Such a separation line for protrusion (203) and protrusion (303) is shown by a dotted line in Figures 2 and 3, respectively. The exact location of this (imaginary) line is irrelevant to the present invention, since the "reinforced" (increased thickness and / or stiffness) release liner of the present invention extends beyond this imaginary line and covers not only at least a portion of the protrusion, but also at least a portion of the remaining area of the dressing. This ensures that the protrusion "benefits" from the stability and stiffness of the entire dressing, particularly the remaining area.
[0014] In an embodiment of the invention, the release liner has areas of increased thickness and / or increased stiffness in the entire area of said protrusions and in part of the area outside said at least one protrusion.
[0015] In an embodiment of the invention, said area of said at least one protrusion is 100 mm 2 ~5000mm 2 , preferably 100 mm 2 ~2000mm 2 and the remaining area is 500 mm 2 ~50,000mm 2 , preferably 1000 mm 2 ~40,000mm 2 is.
[0016] In an embodiment of the invention, the dressing comprises a pad, preferably an absorbent pad, and the backing layer extends beyond the periphery of the pad to define an edge portion along at least part of the contour of the pad, preferably along the entire contour of the pad.
[0017] The presence and association of these end portions is perhaps best illustrated in Figures 1a and 1b, which show dressings (100, 100') having end portions (102, 102') that extend around the entire periphery of the pads (101, 101'), but are particularly emphasized at the bottom of the dressing and that define protrusions (103a, 103a') and protrusions (103b, 103b').
[0018] This end portion of the dressing is generally significantly more flexible and less stiff than the inner (central) portion of the dressing (the "remaining area") which is reinforced by the pad, and therefore this end portion, or portions thereof, may generally be more susceptible to wrinkling, folding, kinking, etc.
[0019] Thus, in an embodiment of the invention, at least a portion of said end portion is encompassed by an area of release liner having increased thickness or increased stiffness or both.
[0020] In an embodiment of the invention, at least a part of said end portion defines at least a part of a protrusion. In a preferred embodiment, at least a part of said end portion is a protrusion.
[0021] In an embodiment of the invention, the dressing comprises a central segment and end portions, the thickness of said central segment being between 1 mm and 20 mm, preferably between 2 mm and 10 mm, while the thickness of said end portions is between 10 μm and 200 μm, preferably between 20 μm and 100 μm.
[0022] In an embodiment of the invention, the maximum distance d1 between the horizontal or vertical (i.e. outermost) edge of at least one protrusion (especially an end portion) and the nearest edge of the pad, in particular measured from the outer edge of the protrusion (end portion) to the outer edge of the pad, is between 10 mm and 80 mm, for example between 25 mm and 60 mm.
[0023] In an embodiment of the invention, at least two lateral edges and / or at least two longitudinal edges of said end extend substantially parallel.
[0024] According to the present invention, the transverse (longitudinal) edges of an end run "substantially parallel" if for a given transverse (longitudinal) edge, a secant or tangent line can be defined that encompasses said transverse (longitudinal) edge, and if a second transverse (longitudinal) edge exists, such an "encompassing" secant or tangent line can also be defined for this edge, and the angle between these two secants or tangents of these two transverse (longitudinal) edges is 0 degrees + / - 45 degrees, preferably 0 degrees + / - 20 degrees, relative to each other. For (perfectly) parallel edges, the angle between these two secants / tangents will be 0 degrees.
[0025] Generally, the release liner acts as a barrier that can protect the sterility of the dressing, including all of its layers, before the dressing is used.
[0026] As used herein, the term "releasably attached" means that the release layer can be manually peeled from the rest of the dressing.
[0027] In an embodiment of the present invention, the removable portions of the release liner are releasably connected to one another, meaning that they are connected such that the portions remain connected unless a separation force is applied to one or all of the portions, and the portions can be separated when a separation force is applied.
[0028] Specifically with regard to the realization of a release liner when it is divided into at least two different parts, the relevant content of WO 2017 / 081012 (Patent Document 1) is relevant and incorporated by reference.
[0029] It is preferred to implement the release liner as two or more separate pieces that can be removed separately, preferably split along a split line.
[0030] It is also within the scope of the present invention to realize the release liner as one integral unit having areas of increased thickness or stiffness or both.
[0031] In embodiments of the present invention, when there are two or more separate portions of the release liner, these two or more separate portions may be made of the same material or different materials.
[0032] According to the present invention, the main function of the adhesive coating is to adhere the release liner to the rest of the dressing. As outlined in more detail below, the adhesive coating may also be embodied as an adhesive layer and may also preferably function as or be part of the wound (body) contact layer.
[0033] In an embodiment of the present invention, the adhesive coating is applied directly onto the pad or onto the release liner, or both.
[0034] In embodiments, the adhesive coating is realized as a layer having a skin-facing side and a non-skin-facing side, and preferably having a thickness of 5 μm to 100 μm, more preferably 10 μm to 60 μm.
[0035] In an embodiment of the invention, an adhesive coating or layer completely or partially covers the pad.
[0036] In an embodiment of the invention, the adhesive coating is adapted to also function as a wound contact layer, and preferably the adhesive coating is a coating comprising a silicone gel.
[0037] According to the present invention, the release liner of the dressing has areas of increased thickness or increased stiffness, or both, in at least part of the area of said at least one protrusion and in part of the area outside said at least one protrusion (the "thicker / stiffer area"), but not in the entire area outside the lateral protrusions.
[0038] The increased thickness or increased stiffness or both is measured relative to the thickness or stiffness or both of the release liner in the remaining area, i.e., the area that is not reinforced with respect to thickness and / or stiffness (the "remaining area").
[0039] In an embodiment of the invention, the increased thickness of the release liner in said portion of the area of the at least one protrusion and in said portion of the area outside the at least one protrusion is in the range of 50 μm to 1000 μm, optionally 100 μm to 500 μm, further optionally 150 μm to 400 μm, and further optionally 180 μm to 300 μm, while the thickness of the release liner in the remaining areas is smaller than in said portion of the area of the at least one protrusion and in said portion of the area outside the at least one protrusion and is in the range of 10 μm to 500 μm, optionally 20 μm to 200 μm, further optionally 20 μm to 180 μm, and further optionally 50 μm to 150 μm.
[0040] In an embodiment of the present invention, the increased thickness of the release liner in at least a portion of the area of the at least one protrusion and in the portion of the area outside the at least one protrusion is at least 25%, preferably at least 40%, greater than the thickness of the release liner in the remaining area.
[0041] In an embodiment of the present invention, the increased stiffness of the release liner, as defined by the load at material deformation in at least a portion of the area of the at least one protrusion and in a portion of the area outside the at least one protrusion, when measured according to the method described below, is between 25N and 150N, preferably between 40 and 80N, while the stiffness of the release liner in the remaining area is between 10N and 60N, preferably between 20 and 40N.
[0042] Without wishing to be bound by theory, it is believed that if the dressing is too stiff; i.e., the stiffness of the remaining area is below the ranges stated above, it will not provide sufficient protection against wrinkle formation when packaged in the individual pack. On the other hand, if the dressing is "too stiff"; i.e., above the specified ranges, the dressing may actually damage the individual pack by "cutting / piercing" the paper or plastic individual pack of the dressing.
[0043] In an embodiment of the present invention, the stiffness of the release liner, defined by the load at the time of material deformation in the area of the at least one protrusion and in the portion of the area outside the at least one protrusion, is at least 25%, preferably at least 40%, greater than the stiffness of the release liner in the remaining area, the stiffness being measured according to the method described herein.
[0044] In embodiments of the present invention, the "stiffer" portion of the release liner may be reinforced relative to the remaining portion of the release liner by including one or more additional layers of material, such as a nonwoven or plastic film, and / or by embossing this portion of the release liner, thereby making the release liner more stiff.
[0045] In principle, there are no restrictions as to the material used for the release liner, so long as it can be adjusted to various degrees of thickness and / or stiffness and the liner material is otherwise flexible enough to conform to the contours of the body.
[0046] In an embodiment of the invention, the release liner is or comprises polyurethane, polyethylene, or polypropylene, or any combination thereof, especially low density polyurethane.
[0047] In an embodiment of the present invention, the release liner comprises polyethylene, polyester, polypropylene, or silicone-coated paper. For example, the release liner may be a polyethylene film having a thickness in the range of 30 to 300 μm, for example, 50 to 150 μm.
[0048] In embodiments, the thicker and / or stiffer portions of the release liner encompass 15% or more, preferably 20% or more, and more preferably 25% or more of the total area of the release liner, while encompassing less than 75%, preferably less than 50%, and more preferably less than 40% of the total area of the release liner.
[0049] In an embodiment of the invention, the dressing has only one axis of symmetry or no axis of symmetry.
[0050] In a preferred embodiment of the invention, the dressing has an axis of symmetry, said axis of symmetry encompassing said at least one protrusion, said axis of symmetry also encompassing said part of the area outside said at least one protrusion that also has said increased thickness or said increased stiffness or both.
[0051] In an embodiment of the invention, said (exactly) one axis of symmetry coincides with said maximum longitudinal extension Y2.
[0052] In an embodiment of the invention, the dressing is divided into three distinct zones along the longitudinal (y) extension of the dressing: a central zone and two side zones, and the release liner has increased thickness and / or stiffness in the central zone.
[0053] In an embodiment of the invention, the dressing is configured for use such that the portion of the release liner having increased thickness and / or increased stiffness is removed first. This embodiment preferably applies to dressings intended primarily for use on the sacrum.
[0054] In other embodiments, the order can be reversed, i.e., the portion of the release liner that does not have the increased thickness and / or increased stiffness is removed first. This embodiment may be relevant for dressings intended primarily for use on the heel.
[0055] In an exemplary embodiment, the release liner may be associated with instructions and / or visual indicators to facilitate removal of the release liner and application of the dressing onto the skin of the human body.
[0056] In an embodiment of the invention, the dressing includes at least one gripping tab, preferably said gripping tab being flush with and projecting outwardly from the periphery of the dressing, for example said gripping tab projecting outwardly from an end portion of the dressing.
[0057] In an embodiment of the invention, the dressing is a dressing for application to contoured body parts, in particular the sacrum, heels, elbows, knees, etc.
[0058] In an embodiment of the invention, the dressings described herein are used in prophylaxis and / or treatment or wound care, preferably in prophylaxis. [Brief explanation of the drawings]
[0059] [Figure 1] Two commercially available dressings are shown for application to contoured body areas, specifically the heel (FIG. 1a) and sacrum (FIG. 1b). [Figure 2] 1b illustrates the dressing of FIG. 1a with the central release liner removed. [Figure 3] 1 shows a dressing suitable for the sacrum with one axis of symmetry and a "w" shaped protrusion at the bottom end. [Figure 4] Illustrated is one embodiment according to the present invention: the central area of the three-part release liner has increased thickness and / or increased stiffness and covers and stiffens the bottom protrusions. [Figure 5] 1 illustrates a dressing according to an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0060] The present invention will now be described in more detail with reference to the accompanying drawings, which illustrate presently preferred embodiments of the invention. However, the present invention may 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 invention to those skilled in the art.
[0061] The adhesive used in the adhesive coating is preferably gentle on the skin and adheres sufficiently to the skin so that the dressing stays in place and maintains its adhesion even after repeated removal and reapplication. The adhesive should also be easily removed without causing trauma.
[0062] In an embodiment of the invention, the adhesive comprises a silicone gel, preferably a soft silicone gel. Suitable silicone gels include two-part RTV systems such as Q72218 (Dow Corning) and SilGel 612 (Wacker Chemie AG), as well as NuSil silicone elastomers.
[0063] In an embodiment of the invention, the adhesive layer of the dressing covers at least 50% of the surface of the pad, preferably at least 60%, and more preferably at least 70% of the pad, which ensures, or at least facilitates, sufficient adhesion of the entire dressing to the patient's skin during use.
[0064] The adhesive layer may be perforated or undrilled.
[0065] In embodiments of the present invention, the adhesive layer may be configured to be a body contacting layer. As used herein, the term "body contacting layer" means a layer that comes into contact with the skin of the wearer.
[0066] In the field of medical dressings, particularly wound dressings, a film provided with an adhesive layer for adhering to a patient is often referred to as a wound contact layer. The dressings of the present invention may be used on areas of a human body that do not have a wound, and therefore the combination of the film and adhesive layer is referred to as a body contact layer.
[0067] The film to which the adhesive layer is applied in such a body / wound contact layer may consist of a thin plastic film or a laminate including a thin plastic film. Suitable materials for the film include, but are not limited to, breathable polyolefin films (such as polyethylene), polyamides, polyester polyurethanes, and silicones. 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 15 to 100 μm, e.g., 40 to 80 μm, preferably 45 to 60 μm.
[0068] As already discussed above, in embodiments of the present invention, the dressing comprises edge portions (see e.g. (102 and 102') in Figures 1a / 1b or (302) in Figure 3). In embodiments, at least the backing layer extends beyond the periphery of the (absorbent) pad and defines edge portions around the contour of the pad, or alternatively only of a portion of the pad. In Figure 1, the backing layer and adhesive layer extend beyond the periphery of the pad and define edge portions around the contour of the pad.
[0069] The adhesive layer is preferably coextensive with and has the same exterior dimensions (transverse and longitudinal extension, including all protrusions) as the backing layer.
[0070] In an embodiment of the invention, and in particular to achieve sufficient adhesive properties, said edge portions have a width of 5 to 60 mm and extend along at least part of the contour of the pad, preferably along the entire pad.
[0071] Smaller sized dressings may have smaller end portions than larger sized dressings.
[0072] In an embodiment of the invention, the corresponding end portions of such a dressing, if present, may be substantially heart-shaped, with the first and second lobed portions forming part of the lobulated top edge of the heart (see FIG. 3). The dressing has an axis of symmetry (304), a maximum lateral extension X2, and a maximum longitudinal extension Y2.
[0073] In this exemplary embodiment, the dressing is symmetrical about a longitudinal centerline (304) and includes a first lobe portion (305) on one side of the longitudinal centerline (304) and a second lobe portion (306) on the other side of the longitudinal centerline. The first and second lobe portions (305 and 306) are separated by a fork-shaped portion ("w" portion) (307) that replaces the pointed lower portion of the heart. Such fork-shaped portion (307) may be a protrusion or may appear to include a protrusion on either side of a split aligned coaxially with the longitudinal centerline. In either case, this protrusion or these two protrusions are advantageously protected from wrinkling or twisting by the incorporation of a reinforced (increased thickness or stiffness or both) portion of the release liner in accordance with the present invention.
[0074] As used herein, the term "lobed portion" refers to a curved or rounded portion of a dressing. In embodiments, the tabs project "outwardly" from the end portion. In this context, inwardly should be understood to mean in a direction toward the inner periphery of the end area, i.e., toward the pad, while outwardly means in the opposite direction.
[0075] The dressing has end regions (302) and pads (301), as well as gripping tabs (308) and (309). The shape of this preferred dressing is adapted to fit the sacral region of the human body. The forked portion allows for improved stay-on ability in the natal cleft region. It is important for this type of dressing to maintain adhesion in this region, as body fluids (e.g., as a result of incontinence) could otherwise get into the dressing and compromise its adhesion to the skin.
[0076] The maximum extension of the protrusion in the transverse (x) direction X1 is 10% to 40% of the maximum extension X2 of the entire dressing in the transverse (x) direction.
[0077] The maximum extension X2 of such preferred sacral dressings is typically in the range of 12 to 30 cm, preferably 15 to 20 cm. The maximum extension X1 of the projection is preferably in the range of 2 to 10 cm, for example 4 to 7 cm, depending on the size of the dressing.
[0078] In an embodiment of the invention, the pad is arranged to taper downwards towards the lower region, having a narrower width in the lower region of the dressing. This shape of the pad allows for proper protection of the coccyx, a bony prominence at risk of developing pressure sores. Such a pad also conforms well to the body in the gluteal cleft area. As shown in Figure 3, this portion of the pad (301) may also be part of the protrusion (303) and thus may help increase the stability / rigidity of said protrusion, preferably together with a reinforced release liner.
[0079] In an embodiment of the invention, the pad is absorbent. The pad may consist of one layer or multiple layers.
[0080] In an embodiment of the invention, the backing layer of the entire dressing is a thin film, sheet, or membrane that is vapor permeable and waterproof. 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.
[0081] In an embodiment of the invention, the backing layer is a polyurethane film and preferably has a thickness of 5 to 40 μm, for example 15 to 25 μm.
[0082] The backing layer may be partially or completely adhered to the pad via an adhesive, such as a pressure sensitive adhesive (eg, an acrylic adhesive).
[0083] In an embodiment, the dressing includes at least one gripping tab, which is preferably flush with and projects outwardly from the periphery of the dressing [see (308) and (309) in Figure 3].
[0084] The gripping tabs guide the caregiver to lift the dressing, inspect the skin underneath the dressing, and then reapply the dressing to the skin (if the skin appears fine). Inspection of the skin may be less frequent if the dressing is clear, but may still be necessary.
[0085] In embodiments, the grip tab is integral with and projects outward from the end. The grip tab may be made of the same material as the end portion, e.g., the backing layer and the body-contacting layer. Thus, the end portion may extend uninterrupted from the end to the grip tab. This is advantageous from a manufacturing standpoint. However, in at least some exemplary embodiments, the grip tab may be made of a different (or the same) material and attached to the end portion.
[0086] Because the skin test is typically performed with the patient lying on their side in bed, in preferred embodiments particularly applicable to sacral dressings, the dressing has at least two gripping tabs so that the caregiver can lift the dressing regardless of which side the patient is lying on. Thus, in embodiments, the gripping tab is a first gripping tab, and the dressing further includes a second gripping tab that is flush with and projects outwardly from the second lobe.
[0087] As best shown in Figure 4, the dressing may be divided into three distinct zones along the longitudinal (y) extension of the dressing: a central zone (410) and two side zones (411 and 412), with the central zone of the release liner preferably being a reinforced portion of the release liner, i.e., having increased thickness or stiffness or both (see shaded area). As noted above, 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 zone to facilitate smooth application of the dressing to the patient's skin.
[0088] Referring back to Figure 2, which illustrates a heel dressing, the central release liner (212a) is preferably removed first. The remaining release liner portions (212b-212e) are then removed and the dressing is slowly applied to the patient's body. In the embodiment illustrated in Figure 2, the central portion (212a) of the release liner may be a stiffer and / or thicker release liner portion (so long as it provides sufficient coverage and protection for the protrusions). Alternatively, the release liner portions 212b-212e may be stiffer and / or thicker than the central portion (212a).
[0089] The characteristic dimensions of a representative dressing are further illustrated in Figure 5, which shows a bottom view of a sacral dressing having a pad (501) and an end portion (502). A protrusion (P) comprising a "w"-shaped extension (506) is separated from the remaining area (RA) by a (phantom) dotted line. As can be seen in this representative embodiment, the protrusion comprises part of the "w" shape of the end portion, but also part of the narrow width of the pad. In this embodiment, the reinforced release liner (509, shaded area) covers not only the entire protrusion, but also a significant portion of the remaining area, thus stabilizing the protrusion.
[0090] Measurement of release liner stiffness (standard: ASTM D882-12) Two different polyethylene films: 100 μm thick and 92 g / m 2(Sample A) and thickness 200 μm and basis weight 184 g / m 2 From the sample (Sample B), a release liner test specimen measuring 25 mm in width and 150 mm in length was punched out. The modulus of elasticity and the peak load at material deformation were determined using a tensile tester (Insight MTS). The tensile tester was calibrated and zeroed according to the instruction manual (Tensile tester: Insight, supplier: MTS, year: 2008). The sample was attached to a clamp and the test speed was set to 50 mm / min. The gauge length was 80 mm.
[0091] The tensile tester was started and the sample was stretched to failure or until 100% elongation was reached. Measurements due to premature failure (i.e., samples that broke in the clamps or were damaged during preparation) were ignored.
[0092] Tensile force and elongation were measured throughout the test, and the following results were obtained from these measurements: Peak Load (N): The maximum load recorded during the test Strain at peak load (%) The Young's modulus at 10% strain was obtained using the following formula: E 10% = stress at 10% strain / 0.1 (calculated based on data points before the material begins to deform, i.e., before the data plot becomes linear)
[0093] The results are summarized in Table 1 below.
[0094] [Table 1] [Explanation of symbols]
[0095] 100, 100' Dressing Supplies 102, 102' end section 103a, 103a' protrusion 103b, 103b' protrusion 301 Pad 302 Edge area 308, 309 Gripping tab 410 Central Band 411, 412 Release liner X1 Horizontal extension Y1 Vertical extension X2 Maximum horizontal extension Y2 Maximum vertical extension
Claims
1. 1. A dressing having a maximum lateral (X2) and maximum longitudinal (Y2) elongation, the dressing has a main body portion and at least one protrusion extending longitudinally and / or laterally from the main body portion, the protrusion having a transverse (X1) or longitudinal (Y1) elongation, or both, that is less than 50% of a maximum transverse (X2) or maximum longitudinal (Y2) elongation, or both, of the entire dressing; the dressing has a first side and a second opposite side, the first side including an adhesive coating having a skin-facing surface adapted to releasably adhere the dressing to a skin surface; the dressing includes a release liner releasably attached to the adhesive coating; the release liner comprises three distinct sections disposed along the length of the dressing, the three distinct sections having a central section and two side sections configured to be separately peeled away; the central portion covers at least a portion of the area of the at least one protrusion and a portion of the area of the body portion extending outside the at least one protrusion; The thickness and / or stiffness of the central portion is increased relative to the thickness and / or stiffness of the side portions. Treatment supplies.
2. The dressing comprises: Backing layer and a pad contoured by a pair of lateral edges extending substantially parallel to one another in a longitudinal direction and a pair of longitudinal edges extending substantially parallel to one another in a transverse direction; Including, "Substantially parallel" means that in the longitudinal direction, for a given longitudinal edge, a secant or tangent line can be defined that includes the longitudinal edge, and there is a second longitudinal edge that can define such an "encompassing" secant or tangent line for this edge, where the angle between the two secants or tangent lines for the two longitudinal edges is 0 degrees + / - 45 degrees relative to one another; and in the transverse direction, for a given transverse edge, a secant or tangent line can be defined that includes the transverse edge, and there is a second transverse edge that can define such an "encompassing" secant or tangent line for this edge, where the angle between the two secants or tangent lines for the two transverse edges is 0 degrees + / - 45 degrees relative to one another; the pad is disposed between the backing layer and the adhesive coating; 10. The dressing of claim 1.
3. 3. The dressing of claim 2, wherein the backing layer extends beyond the periphery of the pad to define an edge portion along at least a portion of the contour of the pad.
4. 3. The dressing of claim 2, wherein the backing layer extends beyond the periphery of the pad to define an edge portion along the entire contour of the pad.
5. 5. A dressing according to claim 3 or 4, wherein at least a portion of the end portion defines at least a portion of a protrusion.
6. A dressing according to claim 3 or 4, wherein the maximum distance d1 between a horizontal or vertical edge of at least one projection and the nearest edge of the pad is between 10 mm and 80 mm.
7. 7. The dressing of claim 1, wherein the increased thickness of the release liner in the area of the at least one protrusion and in the portion of the area extending outward from the at least one protrusion is in the range of 50 μm to 1000 μm, and the thickness of the release liner in the remaining areas is less than the thickness of the release liner in the portion of the area of the at least one protrusion and in the portion of the area extending outward from the at least one protrusion and is in the range of 10 μm to 500 μm.
8. 8. The dressing of claim 1, wherein the increased thickness of the release liner in the area of the at least one protrusion and in the portion of the area extending outward from the at least one protrusion is 25% or more greater than the thickness of the release liner in the remaining area.
9. A dressing as described in any one of claims 1 to 8, wherein when the stiffness of the release liner is measured according to a method in accordance with ASTM D882-12, the increased stiffness of the release liner, as defined by the load at the time of material deformation in the area of the at least one protrusion and in the portion of the area extending outward from the at least one protrusion, is 25N to 150N, and the stiffness of the release liner in the remaining area is 10N to 60N.
10. 10. The dressing of claim 1, wherein the stiffness of the release liner, defined by the load at material deformation in the area of the at least one protrusion and in the portion of the area extending outward from the at least one protrusion, is at least 25% greater than the stiffness of the release liner in the remaining area, wherein the stiffness is measured according to a method in accordance with ASTM D882-12.
11. 11. The dressing according to claim 1, wherein the dressing has a line-symmetric shape having only one axis of symmetry, or an asymmetric shape having no axis of symmetry.
12. 12. The dressing of claim 11, wherein the dressing has an axis of symmetry, the at least one protrusion has an axisymmetric shape that encompasses the axis of symmetry, and similarly, the portion of the area extending outward from the at least one protrusion having the increased thickness and / or the increased stiffness also has an axisymmetric shape that encompasses the axis of symmetry.
13. 13. The dressing of any one of claims 1 to 12, wherein at least one protrusion has a transverse (X1) or longitudinal (Y1) elongation that is no greater than 30% of the maximum transverse (X2) or the maximum longitudinal (Y2) elongation, or both, of the entire dressing.
14. 14. The dressing of any one of claims 1 to 13, wherein the dressing is divided into three distinct zones along the longitudinal (y) extension of the dressing: a central zone and two side zones, and the release liner has increased thickness and / or stiffness in the central zone.
15. A dressing according to any preceding claim, wherein the dressing is for application to an uneven body part.
16. 16. The dressing of any one of claims 1 to 15, wherein the dressing includes at least one gripping tab, the gripping tab being flush with and projecting outwardly from the periphery of the dressing.
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