Wound dressing material
A wound dressing with guided removal direction and adhesive properties minimizes wound damage and pain by ensuring correct orientation, addressing the limitations of existing adhesive coatings.
Patent Information
- Application Number
- JP2021515598
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-09-25
- Filing Date
- 2019-09-16
- Publication Date
- 2025-09-02
- Estimated Expiration
- 2039-09-16
AI Technical Summary
Existing wound dressings often cause pain and extend healing times due to disturbance during removal, despite adhesive silicone coatings that reduce adhesion, which are insufficient in some situations.
A wound dressing with a base, wound-facing layer, and two releasable sheets, where the interface between the sheets determines the removal direction, and printed instructions guide the correct orientation for application to minimize wound damage.
The solution ensures correct orientation of the wound dressing upon application, reducing the risk of wound damage and pain during removal, particularly beneficial for tear wounds.
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Abstract
Description
[Technical Field]
[0001] The present disclosure relates generally to wound dressings for wounds, and in particular to methods of treating wounds, with particular application to reduce the risk of disturbance of the wound when removing the wound dressing. [Background technology]
[0002] Treating wounds with dressings encompasses a wide range of conditions and applications. A corresponding variety of different types of dressings are available for treating wounds. Each type of wound goes through several healing stages and may require different treatment modalities depending on the healing stage. Therefore, treating a wound involves selecting a dressing based on the particular type of wound and the various treatment stages considered. Considerations such as size, location, etc. also play a role in selecting a dressing.
[0003] However, regardless of various considerations, wound treatment necessarily involves periodic replacement of the dressings used to treat the wound. A problem with changing dressings is that the wound is often disturbed during removal of the dressing, resulting in pain and extended healing times. The risk of such wound damage requires extensive nursing time to remove and replace dressings with various techniques that help reduce wound damage and pain.
[0004] This problem is generally solved by reducing the adhesion between the wound and the wound dressing, as exemplified, for example, in WO2017127369A1, where the wound dressing product is arranged to include an adhesive silicone coating provided to reduce the adhesion between the wound and the wound dressing.
[0005] While the solution presented in WO2017127369A1 shows some improvements in reducing the risk of wound damage and pain, there are some situations in which the reduced adhesion is insufficient to prevent wound damage. In view of the above, there appears to be room for further improvement in reducing the risk of wound damage and pain to patients when removing the wound dressing. Summary of the Invention
[0006] In accordance with an aspect of the present disclosure, therefore, there is provided a wound dressing comprising a base having an upper surface and a lower surface, a wound-facing layer disposed on the lower surface of the base, a first release sheet releasably covering and protecting a first portion of the wound-facing layer, and a second release sheet releasably covering and protecting a second portion of the wound-facing layer, wherein the second portion of the wound-facing layer does not overlap the first portion of the wound-facing layer, wherein an interface between the first release sheet and the second release sheet determines the overall direction of the interface, printed or dyed instructions including a direction of removal of the wound dressing are visibly disposed on the upward-facing side of the wound dressing, the upper surface of the wound dressing is disposed on the same side as the upper surface of the base, and the direction of removal of the dressing is essentially perpendicular to the overall direction of the interface and is directed toward the second portion of the wound dressing.
[0007] The present disclosure is based on the recognition that the correct orientation of the wound dressing when first contacting the wound dressing with the patient's skin can be used to ensure that subsequent removal is performed in a manner that reduces the risk of wound damage resulting from removal of the wound dressing. That is, for example, when a nurse or caregiver places a wound dressing relative to the wound, he / she assesses the wound, whereby removal of the first release sheet sets the orientation for applying the wound dressing to the skin, and therefore, by specifically arranging the orientation of the instructions for removing the wound dressing, the wound dressing is believed to eliminate or reduce further wound damage. Thus, the orientation of the first release sheet therefore controls the manner in which the nurse or caregiver applies the wound dressing, and therefore automatically guides the manner in which the same or another (future) nurse or caregiver removes the wound dressing.
[0008] Therefore, an advantage of the following wound dressings according to the present disclosure is that their removal direction is automatically provided correctly upon application to a patient's wound. Wound dressings according to the present disclosure are particularly advantageous in connection with tear wounds (also known as skin tears), which typically involve peeling attached and unattached portions of skin, i.e., "flaps," from the patient and then quickly "reattaching" or "reconnecting" them to ensure wound healing. Thus, consistent with the present disclosure, the wound dressing may be positioned to properly remove the skin flap, not resist the flap, and maintain its viability. Tear wounds are generally viewed as a type of trauma that requires wound closure in a timely manner.
[0009] In accordance with the present disclosure, the phrase "in the overall direction of the interface" should be interpreted broadly and refer to the interface (area) where the first and second release sheets meet (or are disposed adjacent to each other). In accordance with the present disclosure, the first and second release sheets each have a "straight" side facing each other at the interface. Rather, the sides facing each other may be slightly curved (e.g., sinusoidal), jagged, or otherwise disposed. In any case, the overall direction of the interface will be a "normalized direction" relative to the sides of the first and second release sheets where they meet each other.
[0010] Preferably, the wound facing layer comprises an adhesive, such as a relatively low adhesive, for example a silicone gel, which has advantageous characteristics with respect to adhesion during the wound dressing removal process.
[0011] Generally, the adhesive is hydrophobic and preferably includes a base that is adapted to adhere to dry skin. Thus, the term "adherence" should be interpreted broadly to mean that the wound dressing should retain its position once applied to the wound. However, the tack should simultaneously be low enough to reduce the risk of significant disruption or trauma to the wound or surrounding skin when the wound dressing is removed.
[0012] According to the present disclosure, the substrate is preferably perforated, e.g., formed from a sheet of non-fibrous material. A wide range of suitable non-fibrous materials is commercially available from various suppliers. Non-fibrous materials can be produced, for example, by extruding polymer fibers to form long, thin fibers that are fused together to form a woven fabric with an irregular open structure. A substrate providing an adhesive effect (e.g., low-adhesion silicone gel) is desirable to align the substrate without closing the perforations. Alternatively, the perforated substrate can be a plastic sheet, e.g., formed from polyurethane.
[0013] The material and thickness of the base are appropriately selected to provide backing support to the wound-facing layer of the wound dressing, relying on the inherent mechanical strength of the wound-facing layer.
[0014] One or more portions of the wound dressing may optionally be made of a transparent or translucent material, for example, to aid a nurse or caregiver of a patient suffering from a severe trauma in visualizing the flow of air and / or fluid in and out of the space above the wound surrounded by the dressing.
[0015] Silicone gels suitable for use in the present invention are generally hydrophobic and preferably adhesive. Adhesive silicone gels are preferred because they allow the wound dressing to be held in place, but are not adhesive. Such silicone gels are often referred to as soft silicones.
[0016] Most preferably, suitable silicone gels are formed by the reaction between two components that are mixed to form a silicone gel precursor composition shortly before application to a substrate. Typically, the two components are a vinyl-substituted silicone and a hydride-containing silicone. The precursor composition cures to form the silicone gel. While many such compositions cure at room temperature, curing is generally induced or accelerated by the application of heat.
[0017] Gels with different properties can be produced by varying the properties and / or nature of the components used in the reaction. For example, the molecular weight of the various components and / or their degree of substitution with reactive groups can be varied.
[0018] Suitable ingredients for forming silicone gels for use in the dressings of the present disclosure are readily available.
[0019] In a preferred embodiment of the present disclosure, the first and second release sheets each include a peel tab provided at the interface between the first and second release sheets. Alternatively, the first release sheet may be provided with removal instructions prior to removing the second release sheet. Furthermore, it may be desirable to position the wound dressing so that the tabs of the second release sheet are very slightly "hidden" under the tabs of the first release sheet, so that it will be more natural for a nurse or caregiver to remove the first release sheet before removing the second release sheet.
[0020] Furthermore, in some embodiments, it may be desirable to make the first portion of the wound-facing layer smaller (e.g., 50% smaller) than the second portion of the wound-facing layer. Advantageously, this will assist the nurse or caregiver in attaching only the corresponding small "sticky portion" to the patient's skin. The nurse or caregiver can then sequentially remove the second release sheet and slowly apply the remaining wound dressing from the interface between the first and second release sheets to the patient's skin while gazing at the interface.
[0021] It should be understood that the first release sheet and / or the second release sheet may be subdivided into separate portions. Thus, in practice, not only the first release sheet but also the second release sheet may be included in the wound dressing, depending, for example, on the size of the wound dressing. That is, in the case of a relatively large wound dressing, it may be desirable to increase the number of release sheets to 2-3 or more.
[0022] In accordance with the present disclosure, the instructions may be, for example, printed or dyed onto the upward-facing surface of the substrate. That is, for example, it is possible, and in some embodiments preferred, to apply a "screen printing process" (or the like) to form the printed or dyed material. At the same time, it should be understood that the instructions may be formed, for example, during the manufacture of the substrate, and may be somewhat integrated with the substrate.
[0023] Typically, the direction of wound dressing removal is provided by an arrow positioned in the direction of removal to instruct the nurse or caregiver on the direction of wound dressing removal, however, in some embodiments it may be desirable to further position the instructions in a manner such as provided in a diagrammatic illustration to ensure that the wound dressing is removed starting from the correct edge.
[0024] According to another aspect of the present disclosure, there is provided a method of treating a wound, comprising: providing a wound dressing comprising a base having an upper surface and a lower surface, a wound-facing layer disposed on the lower surface of the base, a first release sheet releasably covering and protecting a first portion of the wound-facing layer, and a second release sheet releasably covering and protecting a second portion of the wound-facing layer, wherein the second portion of the wound-facing layer does not overlap the first portion of the wound-facing layer, and wherein an interface between the first release sheet and the second release sheet determines the overall direction of the interface, and wherein printed or dyed instructions including a direction of removal of the wound dressing are visibly disposed on the upward-facing side of the wound dressing, the upper surface of the wound dressing is disposed on the same side as the upper surface of the base, and the direction of removal of the wound-facing layer is essentially perpendicular to the overall direction of the interface and is directed toward the second portion of the wound-facing layer, and applying the wound dressing to a wound on a patient. This aspect of the present disclosure provides similar advantages as discussed above in connection with the previous aspects of the present disclosure.
[0025] In line with the above discussion, the wound may be, for example, a tear wound. Correspondingly, since the tear wound includes a portion that adheres to the skin and a portion that does not adhere to the skin, applying the wound dressing to the wound may include removing a first release sheet, thereby exposing a first portion of the wound-facing layer, contacting the first portion of the wound-facing layer with the portion of the tear wound that adheres to the skin after removing the first release sheet, removing a second release sheet, thereby exposing a second portion of the wound-facing layer, and contacting the second portion of the wound-facing layer with at least a portion of the intact portion of the patient near the non-adherent portion of the tear wound after removing the second release sheet.
[0026] Further features and advantages of the present disclosure will become apparent upon examination of the appended claims and the following details. Those skilled in the art will appreciate that different features of the present disclosure may be combined to create embodiments other than those described below without departing from the scope of the disclosure. [Brief explanation of the drawings]
[0027] Various aspects of the present disclosure, including its particular features and advantages, will be readily understood from the following detailed description and the accompanying drawings: [Figure 1] FIG. 1 shows a detailed view of an exemplary wound dressing according to an embodiment of the present disclosure; [Figure 2A] 1 illustrates a procedure for applying and removing a wound dressing according to the present disclosure; [Figure 2B] 1 illustrates a procedure for applying and removing a wound dressing according to the present disclosure; [Figure 2C] 1 illustrates a procedure for applying and removing a wound dressing according to the present disclosure; [Figure 2D] 1 illustrates a procedure for applying and removing a wound dressing according to the present disclosure; [Figure 3] 1 is a flow chart for applying a wound dressing to a patient in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0028] The present disclosure is described more fully below with reference to the accompanying drawings, in which presently preferred embodiments of the disclosure are shown. However, the present disclosure 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 fully convey the scope of the disclosure to those skilled in the art. Like-referenced features refer to like overall elements.
[0029] Turning now to the figures, and in particular to Figure 1, a wound dressing 100 according to an embodiment of the present disclosure is provided. The wound dressing 100 includes a base 102 having an upper surface 104 and a lower surface 106. The base 102 is preferably perforated and may be formed, for example, from a reinforced mesh, a perforated polyurethane membrane, or a woven structure (although not explicitly shown in Figure 1).
[0030] The wound dressing 100 is typically selected to have a size corresponding to the size of the wound. Thus, the size of the wound dressing 100 (the extent of the base 102) can be independently selected in accordance with the present disclosure. Additionally, the wound dressing 100 does not necessarily have to be rectangular, but can have different shapes, such as a circular or oval shape.
[0031] The wound dressing 100 further includes a wound-facing layer 108 (not explicitly shown in FIG. 1 ) disposed on the underside 106 of the base 102, i.e., on the side of the wound dressing 100 intended to be placed on the patient's skin. The wound-facing layer 108 is desirably slightly adhesive to ensure that the wound dressing 100 stays on the patient's skin without falling off, for example, if the patient moves. The wound-facing layer 108 may include, for example, a silicone gel.
[0032] The strong hydrophilic nature of silicone gel prevents any wound fluids from seeping through to, for example, the healthy skin surrounding the wound and loosening the skin tissue. The mesh structure of the wound dressing 100 allows the dressing to adhere to the surrounding, healthy areas of skin, retaining air and oxygen-rich fluids.
[0033] The porous structure of the substrate 102 allows excess wound exudate to pass through the wound dressing 100. For treatment of wounds under skin tissue regeneration, a dressing according to the present disclosure is preferably combined with an absorbent dressing that is applied over the wound dressing 100. In this manner, excess amounts of wound exudate can be wicked up while simultaneously separating the absorbent dressing from the wound bed, preventing the dressing from adhering to the wound.
[0034] Upon application of the wound dressing 100 to a patient, it is desirable to ensure that the wound-facing layer 108 on the underside 106 of the wound dressing 100 is covered with a non-adhesive agent to ensure easy manipulation of the wound dressing. Specifically, as shown in FIG. 1 , a first release sheet 110 and a second release sheet 112 are positioned to cover and protect a first portion 114 and a second portion 116 of the wound-facing layer 108, respectively. As noted above, in some embodiments, it may be desirable to include additional release sheets, such as a third release sheet. Such adjustment may be desirable, for example, in the case of wound dressings with relatively large areas.
[0035] 1, in the illustrated embodiment, first portion 114 is positioned to have an extent that essentially corresponds to second portion 116. However, it will be understood that the extents may differ, for example, in embodiments in which first portion 114 is relatively smaller than second portion 116.
[0036] As shown in Figure 1, the first 110 and second 112 release sheets are respectively provided with peel tabs 118, 120. In a preferred embodiment, as shown in Figure 1, the first peel tab 118 may be slightly "hidden" by the second peel tab 120, making it intuitive for a nurse or caregiver to remove the first peel tab 118 before the second peel tab 120 when applying the wound dressing to a patient.
[0037] 1, the first portion 114 and the second portion 116 have one side facing each other, forming an interface 122 between the first 114 and second 116 portions. In the illustrated embodiment, the interface is essentially straight, meaning that the sides of the first 114 and second 116 portions facing each other are equally straight. However, the interface 122 may be slightly "wavy" or "jagged." In any case, the overall direction D1 of the interface 122 essentially "cuts" through the essentially rectangular wound dressing 100 and is viewed as a reference direction in the case of a wavy or jagged interface.
[0038] Correspondingly, the top surface 104 of the wound dressing 100 is provided with printed or dyed instructions 124 including the direction D2 of removal of the wound dressing 100. The printed or dyed instructions 124 are visibly positioned on the upward-facing surface of the wound dressing 100, i.e., in the direction that faces away from the patient's skin when the wound dressing 100 is applied to the patient's skin. The instructions 124 are "integrated" with the base 102 or provided on the top surface 104, for example, by screen printing or any other existing or future printing or dyeing method.
[0039] 1, the direction of removal D2 of the wound dressing 100 is essentially perpendicular to the overall interface direction D1 and is further directed from the first portion 114 of the wound-facing layer 108 to the second portion 116. That is, the intended direction of removal D2 of the wound dressing 100 begins with the first portion 114 of the wound dressing 100 and continues through the second portion of the wound dressing 100 until the wound dressing 100 is completely removed, as will be described in further detail below.
[0040] 2A-2D in conjunction with FIG. 3, the process of applying and removing a wound dressing 100 to a patient 200 is illustrated. In FIG. 2A, the lower leg of patient 200 is illustrated. As shown, the patient has a so-called tear wound 202 (also called a skin laceration). A tear wound can result from, for example, shear, friction, and / or blunt force, leading to separation of the superficial layers, and can be partial thickness (separation of the epidermis from the dermis) or full thickness (separation of both the epidermis and dermis from the underlying structures).
[0041] Generally, tear wounds are traumatic injuries that, if not treated properly, have a high potential to become complex chronic wounds. As known to those skilled in the art, tear wounds include "skin-attached portions" and "non-attached portions" (e.g., including what are called skin flaps). The non-attached portions are the "loose" portions of the tear wound that are desired to be "reattached." As understood from the above, it is desired that the wound dressing 100 always removes the skin flap and not go against it, maintaining the viability of the flap, i.e., starting with the skin-attached portion.
[0042] To protect the tear wound 202 and reduce the risk of future complications, typically after the wound cleansing process and approximation of the wound edges, rapid application of a wound dressing, such as wound dressing 100, is desired. Thus, in accordance with the present disclosure, wound dressing 100 is provided, which wound dressing 100 is formed in accordance with the discussion provided above.
[0043] 2A, the nurse or caregiver optionally performs a wound cleansing process and approximation of the wound edges, and then applies the wound dressing 100 to the tear wound 202 of the patient 200 by first removing the first release sheet 110 (typically starting at the interface 122 using the peel tab 118), thereby exposing the first portion 114 of the wound-facing layer 108. The adhesive surface of the first portion 114 of the wound-facing layer 108 (at S2) is then brought into contact with the skin adhesive portion of the skin laceration 202, as shown in FIG.
[0044] Once the first portion 114 contacts the patient's skin (S3), the nurse or caregiver removes the second release sheet, thereby exposing the second portion 116 of the wound-facing layer, and then contacts the second portion 116 of the wound-facing layer, at least partially, with an unwounded portion of the patient's skin near the unadhered portion of the tear wound 202 (S4).
[0045] When correctly attached to the patient 200 (S3) in relation to the "orientation" of the tear wound 202, i.e., in relation to the adherent and non-adherent portions of the tear wound 202, the intended direction D2 of removal of the wound dressing 100 will also be correct.
[0046] That is, by positioning the release sheets 110, 112 in the manner defined by the present disclosure, the risk of the wound dressing 100 being removed incorrectly may also be reduced, which would be the case if the nurse or caregiver began by removing the second portion 116 of the wound dressing 100. However, in accordance with the present disclosure, the nurse or caregiver is automatically provided with correct instructions regarding the direction D2 of removal of the wound dressing 100, ensuring that the nurse or caregiver begins with the first portion 114 of the wound dressing 100.
[0047] As shown in FIG. 2C, the removal direction D2 of the wound dressing 100 is visually indicated to the nurse or caregiver, and means that the removal instruction is to place the wound dressing 100 with the surface facing upward relative to the upper surface 104 of the base 102 and the upward-facing side of the wound dressing placed on the same side of the base 102.
[0048] In FIG. 2D, the wound dressing 100 is completely removed, showing how the tear wound 202 is at least partially healed.
[0049] It should be understood that wound dressings according to the present disclosure can be used for human or veterinary use.
[0050] Although a sequence is shown in the figures, the order of the steps may differ from that depicted. Also, two or more steps may be performed simultaneously or with partial concurrence. Such variations are dependent upon the system selected and designer choice. All such variations are within the scope of this disclosure.
[0051] Furthermore, while this disclosure has been described with reference to specific exemplary embodiments thereof, many different variations, modifications and the like will become apparent to those skilled in the art.
[0052] Additionally, variations of the aspects of the present disclosure can be understood and effected by those skilled in the art in practicing the present disclosure, from a study of the drawings, the disclosure, and the appended claims.
[0053] Moreover, in the claims, the word "comprising" does not exclude other factors or steps, and the indefinite article "a" or "an" does not exclude a plurality.
[0054] Moreover, in the foregoing description, various embodiments have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings.
[0055] The present embodiments have been chosen and described to provide the best illustration and practical application of the principles of the present disclosure and to enable those skilled in the art to utilize various embodiments with various modifications suited to the particular use envisaged.
[0056] All such modifications and variations are within the scope of the disclosure as defined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.
Claims
1. A wound dressing (100), comprising: a substrate (102) having an upper surface (104) and a lower surface (106); a wound-facing layer (108) comprising an adhesive and disposed on the underside of the substrate; a first release sheet (110) releasably covering and protecting a first portion (114) of the wound-facing layer; and a second release sheet (112) releasably covering and protecting a second portion (116) of the wound facing layer, the second portion of the wound facing layer not overlapping the first portion of the wound facing layer; Including, where: the first and second portions of the wound-facing layer each have a surface facing each other and defining an interface (122) between the first and second portions of the wound-facing layer; an interface between the first and second portions of the wound-facing layer covered by the first and second release sheets, respectively, defines a direction of the overall interface (D1); each of the first and second release sheets including a peel tab (118, 120) provided at an interface between the first and second release sheets; The peel tab (118) of the first release sheet (110) is positioned to hide the peel tab (120) of the second release sheet (112); printed or dyed instructions (124) including a direction (D2) for removal of the wound dressing are visibly disposed on the upward-facing side of the wound dressing, the upward-facing side of the wound dressing being disposed on the same side as the top surface of the substrate; and the direction of removal (D2) of the wound dressing is essentially perpendicular to the overall interface direction (D1) and is directed towards the second part of the wound-facing layer; Wound dressings.
2. 10. The wound dressing (100) of claim 1, wherein the wound-facing layer comprises a silicone gel.
3. 3. The wound dressing (100) of claim 1 or 2, wherein the instructions are printed or dyed on the top surface of the substrate.
4. The wound dressing (100) of any one of claims 1 to 3, wherein the instructions are provided for removal of the wound dressing.
5. The wound dressing (100) of any one of claims 1 to 4, wherein the substrate is a hydrophobic adhesive.
6. The wound dressing (100) of any one of claims 1 to 5, wherein the substrate comprises a reinforcing mesh.
7. 7. The wound dressing (100) of claim 6, wherein the reinforcing mesh comprises a flexible and elastically stretchable woven material.
8. A wound dressing (100) according to any one of the preceding claims, wherein the first portion of the wound facing layer is smaller than the second portion of the wound facing layer.
9. 9. The wound dressing (100) of claim 8, comprising instructions for removal of the first release sheet prior to removal of the second release sheet.
10. The wound dressing (100) of any preceding claim, wherein the substrate comprises a perforated plastic sheet.
11. 11. The wound dressing (100) of claim 10, wherein the perforated plastic sheet is formed from polyurethane.
Citation Information
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