Printed medical dressing

Abstract

The present disclosure generally relates to a medical dressing (1) comprising a plurality of layers and having a first side facing a patient's skin or wound during use and an opposite second side wherein the plurality of layers comprises a backing layer (2), an adhesive skin-contacting layer (3) and an absorbent pad (4) comprising one or more pad-forming layers (4a-4c); the absorbent pad (4) is arranged between the backing layer (2) and the adhesive skin-contacting layer (3), in which at least one of the layers of the medical dressing (1) comprises a UV-absorbing polymeric material, characterized in that the medical dressing (1) comprises at least one printed mark (5) visible on a second side of the medical dressing (1), and the printed mark (5) is a UV laser printed mark. The present disclosure also relates to a method for printing a medical dressing (1) as defined above.

Description

Technical Field

[0001] This disclosure generally relates to a medical dressing comprising multiple layers and having a first side facing a patient's skin or wound during use and an opposing second side, wherein said multiple layers include a backing layer, an adhesive skin contact layer, and an absorbent pad. The medical dressing includes at least one printed mark visible on the second side of the medical dressing. This disclosure also relates to a method of manufacturing such a medical dressing. Background Technology

[0002] Adhesive medical dressings are frequently used for wound care, both to treat wounds and scars, and to prevent them from developing in the first place.

[0003] Adhesive medical dressings typically consist of an adhesive skin contact layer that is positioned to contact the patient's skin or wound, and a top layer commonly referred to as a backing layer. In many cases, particularly when the dressing is to be applied to wounds with moderate or high exudation, the dressing also includes a wound pad positioned between the backing layer and the adhesive skin contact layer. To protect the dressing from contamination, a release liner is applied over the adhesive skin contact layer.

[0004] In many cases, it is desirable to print markings on medical dressings. For example, such markings may be necessary to create a more visually appealing impression or to guide caregivers and healthcare professionals in the correct use or application of dressings.

[0005] Until now, such use-related information has typically been provided in an instruction manual (“Instructions for Use”, IFU), which is inserted into the package containing the individual dressings. However, this IFU is often not used or present in actual care situations and is easily lost or misplaced.

[0006] In some cases, printed markings, such as printed instructions or graphic elements, may be provided on the release liner of the dressing. The reason for printing on the release liner is usually to avoid the colored inks inside the medical dressing. Medical dressings are applied to a patient's wound or skin, and it is generally necessary to avoid the risk of ink interfering with the wound or skin. Printing on the release liner reduces this risk because the release liner is peeled off before the dressing is applied to the skin.

[0007] However, as the release liner is peeled off, the printed markings (and instructions) are thus removed from the dressing.

[0008] In view of this, there is still room for improvement in the field of printed medical dressings. Therefore, there is a need to provide a safe and reliable printed medical dressing in which the printed markings are visible and observable even after the medical dressing has been applied to a patient's skin or wound. Summary of the Invention

[0009] In view of the above problems, the purpose of this disclosure is to provide improvements in the field of printed medical dressings.

[0010] According to a first aspect, a medical dressing is provided comprising a plurality of layers and having a first side facing a patient's skin or wound and an opposing second side during use, wherein the plurality of layers include a backing layer, an adhesive skin contact layer, and an absorbent pad comprising one or more pad-forming layers; the absorbent pad is disposed between the backing layer and the adhesive skin contact layer, wherein at least one of the plurality of layers of the medical dressing comprises a UV-absorbing polymer material; the medical dressing includes at least one printed mark visible on the second side of the medical dressing, and the printed mark is a UV laser-printed mark.

[0011] This disclosure is based on the understanding that UV laser-printed markings, i.e., markings formed by a UV laser, provide safe and reliable printing, independent of the generation of any harmful substances during printing. Therefore, medical dressings can be safely applied to a patient's skin or wounds.

[0012] Unlike traditional ink-printed markings, UV laser-printed markings do not require the addition of ink or colorants. This helps prevent such substances from potentially washing off into a patient's wound or skin. Furthermore, no heat is generated during printing, whereas laser printing using, for example, infrared light, does. The heat generated during printing can potentially damage the material being printed.

[0013] Furthermore, UV laser-printed markings are permanent and will not fade. In contrast, traditional ink-based printing systems carry a high risk of incomplete or faded markings.

[0014] Products printed with UV lasers can also resist damage after marking, such as from friction, heat, and transportation.

[0015] Traditional ink marking can also lead to carbon dioxide emissions. Since no ink is used in the printed markings disclosed herein, such carbon dioxide emissions are eliminated.

[0016] UV laser-printed markings can be provided by directing a UV laser beam with a wavelength of 320 nm to 380 nm (typically around 355 nm) toward a second side of a medical dressing. The UV laser emits high-energy photons that break polymer bonds in the UV-absorbing polymer material of the medical dressing. As the polymer bonds break, the material changes color and provides a visible mark. The reaction that breaks the polymer bonds is a photochemical reaction, also known as photolysis.

[0017] As described above, printing with a UV laser allows for the creation of visible markings without the formation of any harmful substances (see Example 2). Therefore, medical dressings can be safely applied to a patient's wounds or skin.

[0018] At least one printed mark is visible on the second side of the dressing. Therefore, the printed mark is visible when the patient wears the medical dressing. This is beneficial for conveying product identification information and specific usage information that can guide caregivers in the proper use or application of the medical dressing. Furthermore, such a printed mark can also be used to create a more visually appealing impression.

[0019] In an exemplary embodiment, the layer comprising the UV-absorbing polymer material is one of the pad forming layers or a backing layer.

[0020] The backing layer is the top layer of the dressing; that is, the layer facing the observer (such as a caregiver).

[0021] However, it is also conceivable to provide visible markings on the pad forming layer. For example, in embodiments where the dressing includes a transparent, non-UV-absorbing backing layer, the UV-absorbing polymer material of the wound pad's pad forming layer can be a printed layer. The printed markings remain visible on the second side of the medical dressing.

[0022] In an exemplary embodiment, the UV-absorbing polymer layer also includes pigments.

[0023] Pigments are additives or substances that impart color to layers. This enhances the UV absorption properties of polymer materials and also improves the contrast and focus of UV laser beams. This, in turn, enhances the visibility of printed markings on medical dressings.

[0024] Therefore, the layer comprising the UV-absorbing polymer material can be colored or slightly colored. The layer comprising the UV-absorbing polymer material is typically translucent.

[0025] Pigments can be UV-absorbing.

[0026] In an exemplary embodiment, the UV-absorbing polymer material is polyurethane, polyamide, or polyethylene.

[0027] These materials are commonly used wound dressing materials, including backing layers, release liner, foam wound pads, etc.

[0028] In an exemplary embodiment, the layer comprising the polymer material is a backing layer, and the UV-absorbing polymer material is polyurethane.

[0029] For example, the backing layer may be a polyurethane film or a laminate containing a polyurethane film.

[0030] In an exemplary embodiment, the layer comprising the polymer material may be a pad forming layer, wherein the backing layer is transparent and does not absorb UV.

[0031] This cushioning layer is typically arranged to contact the backing layer. Therefore, the cushioning layer is the uppermost layer of the wound pad.

[0032] The cushion forming layer can be polyurethane foam.

[0033] Alternatively, the pad forming layer can be a masking layer; that is, a layer configured to mask wound exudate. The masking layer can be a colored layer that masks blood and any other wound fluid in the absorbent pad, but still allows markings to be visible on the second side of the dressing.

[0034] The pad forming layer may include pigments. Pigments can enhance the absorption of UV lasers.

[0035] When the markings are printed on the pad forming layer, the backing layer is transparent and does not absorb UV light. This makes the printed markings visible on the second side of the medical dressing. A UV laser beam is transmitted through the backing layer and absorbed by the underlying pad forming layer, thus providing the printed markings.

[0036] In an exemplary embodiment, at least one printed mark may be a graphic element and / or a text element.

[0037] Graphic elements can be symbols, graphics, images, photographs, or visual elements. Graphic elements can be associated with a brand, or they can be used to convey information, such as product identification information or information about specific uses of medical dressings.

[0038] Text elements can be, for example, brand names, sub-brands, product descriptors, or size indicators. Text elements can also be text messages, which may be tailored to a specific patient, purpose, or event.

[0039] In an exemplary embodiment, at least one printed mark indicates the proper use or application of the medical dressing.

[0040] As previously mentioned, specific uses are often included within the IFU, and as previously noted, the IFU typically becomes displaced after the dressing is applied to the patient's skin. Providing such instructions directly on the dressing offers caregivers clear and straightforward guidance on how to properly use and / or apply the dressing.

[0041] In an exemplary embodiment, at least one printed mark is a label readable by an electronic device, preferably a barcode or QR code.

[0042] Barcodes or QR codes can encode internet or website addresses containing technical and / or purpose-specific information related to medical dressings.

[0043] Therefore, information about medical dressings can be easily accessed. Until now, this information has typically been stored in the IFU (Intra-Fluid Function Unit) and is usually inaccessible after the dressing has been applied to the patient.

[0044] In an exemplary embodiment, at least one printed mark may be a batch number, production batch number, and / or country indication.

[0045] This marking is beneficial for regulatory purposes, anti-counterfeiting, and potential product recalls, and enables product authentication. Therefore, each dressing can be tracked and traced, for example, back to the earliest step in manufacturing.

[0046] Providing printed country instructions also helps prevent illicit imports; that is, the importation of branded products into a market or country and their sale there without the consent of the trademark owner in that market or country. The country instructions can be the country of manufacture or the country of sale.

[0047] It is also conceivable that information about batch numbers, production batch numbers, or national instructions could be encoded using QR codes or barcodes.

[0048] According to another aspect, a method for printing medical dressings is provided, comprising: a) Provide a medical dressing comprising multiple layers and having a first side facing the patient's skin or wound and an opposing second side during use, wherein the multiple layers include a backing layer, an adhesive skin contact layer, and an absorbent pad comprising one or more pad-forming layers; the absorbent pad is disposed between the backing layer and the adhesive skin contact layer. b) Printing a medical dressing by directing one or more UV laser beams toward a second side of the medical dressing, such that the UV laser beams form at least one printed mark on the medical dressing.

[0049] The method disclosed herein is advantageous because printing can be precisely controlled, and markings can be customized to specific and desired locations on medical dressings. In contrast, conventional ink printing often suffers from skewing problems and the risk that the printed content will be altered in subsequent processing steps. Therefore, the method disclosed herein provides a controlled and customized means for printing.

[0050] In the first step (step a), a medical dressing is provided using conventional dressing manufacturing techniques. The medical dressing comprises multiple layers, and at least one of these layers comprises a UV-absorbing polymer material.

[0051] Step b) of printing is accomplished by passing one or more UV laser beams toward a second side of the medical dressing. A layer comprising a UV-absorbing polymer material absorbs the UV laser, thereby forming at least one printed mark on the medical dressing.

[0052] Step b) of printing can be performed as an online step in the manufacturing process of medical dressings.

[0053] The method may also include the following steps: a') The medical dressing is arranged in a package comprising at least a front layer and a back layer, wherein at least a portion of the front layer is transparent and does not absorb UV, and the medical dressing is arranged in the package such that a second side of the dressing is visible through the transparent and UV-non-absorbent portion of the front layer, wherein step a') is performed prior to step b), and wherein step b) of printing is performed by passing one or more UV laser beams through the transparent and UV-non-absorbent portion of the front layer.

[0054] Therefore, printing step a' is completed while the dressing remains inside the packaging.

[0055] The medical dressing is arranged such that the second side of the dressing is visible through the transparent portion of the front layer. Therefore, the dressing is arranged such that its top layer (i.e., the backing layer) is visible through the packaging.

[0056] A UV laser beam passes through the transparent, non-UV-absorbing portion of the front layer and is absorbed by the UV-absorbing polymer material in the medical dressing. The UV-absorbing polymer undergoes a photolysis reaction, breaking the polymer bonds and providing a visible mark on the medical dressing. The transparent front layer of the packaging does not absorb UV light and therefore remains unaffected by the UV laser beam.

[0057] Therefore, the dressing should be protected from potential contaminants or substances during the printing process.

[0058] The method may also include a step of sterilizing the packaging and medical dressing (1) prior to step b) of printing the medical dressing.

[0059] Therefore, printed markings can be provided on sterile dressings without altering the sterility of the dressing or the sterile interior of the packaging. Furthermore, the sterilization process does not negatively affect the printability of medical dressings.

[0060] Packaging and dressings are usually sterilized at the same time.

[0061] It is preferable to seal the packaging before printing step b).

[0062] Other features and advantages of this disclosure will become apparent when examined in light of the appended claims and the following description. Those skilled in the art will recognize that different features of this disclosure can be combined to create embodiments other than those described below, without departing from the scope of this disclosure. Attached Figure Description

[0063] Various aspects of this disclosure, including its particular features and advantages, will be readily understood from the following detailed description and accompanying drawings, wherein: Figure 1 A medical dressing comprising printed markings on a backing layer, according to an exemplary embodiment of the present disclosure, is shown. Figure 1 In the image, the medical dressing is arranged in the packaging, and portions of the dressing and packaging have been cut away to show the individual layers.

[0064] Figure 2 A top view of a medical dressing according to an exemplary embodiment of the present disclosure is shown, which is provided with printed markings in the form of QR codes and text messages.

[0065] Figure 3 A top view of a medical dressing, seen from a second side, is shown. The dressing includes printed markings in the form of cutting guide lines that indicate how the dressing should be cut.

[0066] Figure 4 It shows when Figure 3 The medical dressing has been cut along the printed cutting guide lines and then worn by the patient.

[0067] Figure 5a A method for printing medical dressings according to an exemplary embodiment of the present disclosure is illustrated schematically.

[0068] Figure 5b It shows along Figure 1 A cross-sectional view of line AA in line a.

[0069] Figure 6 The UV laser printer used in Examples 1 and 2 is illustrated schematically.

[0070] Figure 7a , Figure 7b and Figure 7c A photograph of the printed wound dressing of Example 1 is shown. Detailed Implementation

[0071] This disclosure will now be described more fully below with reference to the accompanying drawings, which illustrate presently preferred embodiments of the disclosure. However, this disclosure may be implemented 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 this disclosure to those skilled in the art. The same reference numerals throughout refer to the same elements.

[0072] Figure 1 The diagram schematically illustrates a medical dressing. In this figure, the medical dressing 1 is arranged in packaging 7.

[0073] like Figure 1 and Figure 5b As best shown, the medical dressing 1 comprises multiple layers and has a first side facing the patient's skin or wound during use and an opposing second side, wherein the multiple layers include a backing layer 2, an adhesive skin contact layer 3, and an absorbent pad 4 comprising one or more pad-forming layers 4a-4c; the absorbent pad 4 is disposed between the backing layer 2 and the adhesive skin contact layer 3, wherein at least one of the multiple layers of the medical dressing 1 comprises a UV-absorbing polymer material; the medical dressing 1 includes at least one printed mark 5 visible on the second side of the medical dressing 1, and wherein the printed mark 5 is a UV laser-printed mark.

[0074] As used herein, the term "UV laser-printed mark" refers to a mark formed by localized modification of a UV-absorbing polymer material. UV laser-printed marks contain no ink or colorant. Upon absorbing UV light, the polymer bonds in the UV-absorbing polymer material break, resulting in a mark visible on the second side of the dressing. The printed mark is formed by one or more UV laser beams. The wavelength of the UV laser is typically in the range of 320 nm to 380 nm, preferably 355 nm or about 355 nm.

[0075] "UV-absorbing polymer materials" are polymer materials configured to absorb UV light. Upon absorbing UV light, a photochemical reaction occurs, which breaks polymer bonds, thereby creating a permanent mark visible on the second side of the dressing.

[0076] The UV-absorbing polymer material is included in one layer of a multilayer medical dressing.

[0077] Typically, the layer that includes the UV-absorbing polymer material is one of the pad forming layers or the backing layer.

[0078] The backing layer 2, absorbent pad 4, and adhesive skin contact layer 3 can be co-extended; that is, they can have the same surface area. This configuration in... Figure 3 As shown in the image.

[0079] Alternatively, the backing layer 2 and the adhesive skin contact layer 3 are configured to extend around the contour of the absorbent pad 4 to form a boundary portion 11. This type of medical dressing is commonly referred to as a "boundary dressing." Figure 1 , Figure 2 and Figures 5a-5b The border dressing is shown in the image.

[0080] Medical dressings 1 typically also include a release liner 10 that is removably attached to the adhesive skin contact layer 3. The release liner protects the skin contact layer (and the dressing) from contamination before use. The release liner 10 extends together with the adhesive skin contact layer 3 in both length and width.

[0081] Therefore, when the dressing is placed in package 7, such as Figure 1 and Figures 5a-5b As shown, the release liner 10 is attached to the adhesive skin contact layer 3. The medical dressing 1 is arranged in the packaging 7 such that the backing layer 2 of the medical dressing 1 faces the front layer 8 of the packaging 7 (and is visible through the transparent portion of the front layer 8), while the release liner 10 faces the rear layer 9 of the packaging 7, as shown. Figure 5b The best example shown is...

[0082] The "backing layer" is the top layer of the dressing; that is, the outermost layer of the dressing. Desiredly, the backing layer is a thin and flexible layer that allows it to stretch and conform to the wearer's movements. The backing layer may include a UV-absorbing polymer material. The backing layer may be a polymer film. Suitably, the backing layer includes a polyurethane film. The backing layer may also be a laminate of a nonwoven layer and at least one polymer film (e.g., a polyurethane film). For example, in some embodiments, the backing layer may be a laminate of at least one non-UV-absorbing layer and a UV-absorbing layer.

[0083] The thickness of the backing layer can be in the range of 15μm to 50μm, preferably 20μm to 40μm.

[0084] In an exemplary embodiment, the backing layer is translucent and / or colored.

[0085] An "adhesive skin contact layer" is configured to removably adhere the dressing to the skin surface. In other words, the adhesive skin contact layer is configured to come into contact with the wearer's skin or a wound. This layer may also be referred to as a "wound contact layer."

[0086] The adhesive skin contact layer preferably comprises a silicone adhesive; for example, a silicone gel. Adhesive skin contact layers comprising silicone gels are skin-friendly and easy to remove without causing trauma. They adhere fully to the skin, allowing the dressing to remain in place, but are configured to maintain their adhesion during repeated removal and reapplication.

[0087] An adhesive skin contact layer comprising a silicone adhesive can be provided as a coating on an absorbent pad, such as on the bottommost pad-forming layer of the absorbent pad. The adhesive skin contact layer can also comprise two layers. For example, the adhesive skin contact layer can comprise a polymer-based film and a silicone gel layer, wherein the silicone gel layer is configured to contact the wearer's skin during use.

[0088] This adhesive skin contact layer is suitable for use in implementations where the dressing is a border dressing.

[0089] The polymer-based membrane can be a breathable membrane and may include, for example, polyethylene, polyamide, polyester, or polyurethane. Preferably, the polymer-based membrane includes polyurethane. The thickness of the polyurethane membrane can be from 15 μm to 100 μm, for example from 20 μm to 80 μm, preferably from 20 μm to 60 μm.

[0090] Examples of suitable silicone gels for use in the adhesive skin contact layer 102 and / or the silicone gel layer 102b include two-component RTV systems such as Q72218 (Dow Corning) and SilGel 612 (Wacker Chemie AG) mentioned herein, and NuSil silicone elastomers. In embodiments of the invention, the adhesive may comprise a soft silicone gel having a softness (penetration) of 8 mm to 22 mm, for example 12 mm to 17 mm, measured by methods based on ASTM D 937 and DIN 51580, described in European Patent Application No. 14194054.4. The thickness of the adhesive skin contact layer is typically at least 20 μm. The thickness of the adhesive skin contact layer may be from 100 μm to 200 μm.

[0091] The adhesive skin contact layer 3 can be perforated or non-perforated.

[0092] In embodiments where the dressing includes the boundary portion 11, the adhesive skin contact layer 3 typically includes multiple perforations, at least in the area beneath the absorbent pad 4.

[0093] like Figure 1 and Figure 5b As shown, the absorbent pad 4 may include one or more pad forming layers 4a-c.

[0094] The absorbent pad 4 may, for example, comprise an absorbent polyurethane foam layer. It is also conceivable that the absorbent pad 4 is composed of an absorbent polyurethane foam layer.

[0095] The absorbent pad 4 may further include a superabsorbent layer; that is, a layer comprising a superabsorbent material. The superabsorbent material may be superabsorbent polymer (SAP) particles or superabsorbent fiber (SAF). The superabsorbent material is capable of handling large amounts of wound exudate.

[0096] The absorbent pad 4 may also include a liquid distribution layer. The liquid distribution layer may include any material capable of effectively distributing exudate. For example, the liquid distribution layer may include a nonwoven material.

[0097] This layered pad structure prevents body fluid from accumulating near the skin and improves the overall liquid handling capacity of medical dressings.

[0098] exist Figure 1 and Figure 5b In this context, the medical dressing may include, for example, a superabsorbent layer 4a, a liquid distribution layer 4b, and a polyurethane foam layer 4c.

[0099] Typically, the layer containing the UV-absorbing polymer material is either a backing layer 2 or a pad forming layer 4a-c. In embodiments where the layer containing the UV-absorbing material is a pad forming layer 4a-c, the UV-absorbing polymer material is included in the uppermost layer of the absorption pad.

[0100] The layer including the UV-absorbing polymer material may further include pigments.

[0101] This disclosure is not limited to the use of specific pigments, as long as the pigment imparts color to the layer. The layer containing the UV-absorbing polymer material can be, for example, beige or white. Other colors are also conceivable.

[0102] The pigment can be a UV-absorbing pigment.

[0103] UV-absorbing polymer materials can be polyurethane, polyamide, or polyethylene.

[0104] These materials are suitable for use in various layers of dressings. Polyurethane, polyamide, or polyethylene layers can be used, for example, as sublayers of adhesive skin contact layers or as backing layers. Pad forming layers containing polyurethane foam are also suitable. Polyurethane foam is beneficial for absorbing large amounts of wound exudate.

[0105] The layer including the UV-absorbing polymer material can be a backing layer 2, and wherein the UV-absorbing polymer material is polyurethane. Figure 1 In the middle, the printed mark 5 is set on the backing layer 2, which includes a UV-absorbing polymer material.

[0106] Typically, backing layer 2 is a polyurethane layer.

[0107] Similarly, it is conceivable that the layer including the UV-absorbing polymer material is a pad-forming layer, wherein the backing layer is transparent and does not absorb UV.

[0108] In embodiments where the pad forming layer 4a-c includes a UV-absorbing material, the backing layer does not absorb UV and is transparent. Therefore, the backing layer will not be affected by UV laser beams.

[0109] A "non-UV-absorbing" backing layer means that UV laser light will pass through the backing layer without affecting its material properties and without forming a visible mark. Small amounts of UV laser light may be absorbed or deflected by the material, but no visible mark will be obtained.

[0110] For example, Figure 3 The medical dressing illustrated herein typically comprises a polyurethane foam layer and a transparent backing layer heat-laminated onto the polyurethane foam layer. Therefore, the printing mark 5 can be printed on the polyurethane foam layer.

[0111] At least one print mark 5 can be a graphic element and / or a text element.

[0112] As used herein, the term "graphic element" means symbols, graphics, images, photographs, logos, shapes, patterns, and / or visual elements. Graphic elements may be associated with a brand, or they may be used to convey information, such as product identification information or information about a specific purpose of medical dressing 1.

[0113] "Text elements" can be brand names, sub-brands, product descriptors, alphabets, numbers, and / or size indicators. Text elements can also be text messages that can be tailored to a specific patient, purpose, or event.

[0114] Figure 2 The image shows a dressing that includes printed markings in the form of text messages.

[0115] The flexible printing method disclosed herein allows for the provision of various customized and event-specific markings on medical dressings 1.

[0116] At least one printed mark 5 may indicate the correct use or application of the medical dressing 1.

[0117] Such printed instructions are useful in a variety of applications. For example, if a dressing has a “complex” shape, such as multiple protruding borders, which is often the case for heel dressings (and other dressings to be applied to well-defined body parts), the printed markings can indicate the correct way to apply the dressing to that body part.

[0118] In addition, such as Figure 3 As shown, the medical dressing 1 may include printed markings 5 ​​in the form of cutting guide lines. The cutting guide lines instruct caregivers on how to cut the dressing into multiple dressing pieces, which can be used under a medical device. Figure 4 The image shows a patient wearing dressing 12a-d, and the dressing arrangement can be used, for example, under a CPAP mask.

[0119] At least one printed mark 5 may be a label readable by an electronic device. In other words, at least one printed mark may be a machine-readable code or label. A machine-readable code is a code configured to store information in a format that can be quickly and accurately decoded by a machine (e.g., an electronic device). Examples of machine-readable codes include QR codes, barcodes, data matrix codes, and shot codes.

[0120] Medical dressings including printed machine-readable codes, for example in Figure 2 and Figures 5a-5b As shown in the image.

[0121] Machine-readable codes (such as barcodes or QR codes) can encode technical and / or purpose-specific information related to medical dressings. For example, machine-readable codes can encode the internet or URLs containing technical and / or purpose-specific information related to medical dressings.

[0122] At least one printed mark 5 can be a batch number, production batch number, or national instruction.

[0123] This marking is beneficial for regulatory purposes, anti-counterfeiting, and potential product recalls, and enables product authentication. Therefore, each dressing can be tracked and traced, for example, back to the earliest step in manufacturing.

[0124] Until now, for example, batch numbers could be provided on the packaging containing the dressing. However, the packaging is usually discarded after the medical dressing has been applied. This makes dressing traceability more difficult, as potential "problems" may only be detected later.

[0125] It is also conceivable that printed markings could include batch serial numbers; that is, exact serial numbers among many dressings. This would be useful for accurately tracking potential errors in the manufacturing chain.

[0126] Printed country instructions also help prevent illicit imports, a common problem in the field of advanced medical dressings. The country instructions can be the country of manufacture or the country of sale.

[0127] It is also conceivable that information about batch numbers, production batch numbers, or national instructions could be encoded using machine-readable codes (such as QR codes or barcodes).

[0128] According to another aspect, such as Figure 5a and Figure 5b As shown, a method for printing medical dressings is provided, comprising: a) Provide a medical dressing 1 comprising multiple layers and having a first side facing the patient's skin or wound during use and an opposing second side, wherein the medical dressing 1 comprises a backing layer 2, an adhesive skin contact layer 3, and an absorbent pad 4 comprising one or more pad-forming layers 4a-c; the absorbent pad 4 is disposed between the backing layer 2 and the adhesive skin contact layer 3, wherein at least one of the multiple layers of the medical dressing 1 comprises a UV-absorbing polymer material. b) Printing the medical dressing 1 by passing one or more UV laser beams 6 toward the second side of the medical dressing 1, such that the UV laser beams form at least one printed mark 5 on the medical dressing 1.

[0129] The steps of providing medical dressings a) can be performed using techniques and manufacturing processes known to those skilled in the art.

[0130] The layers of a dressing can be attached by adhesive or lamination.

[0131] Step b) of printing the medical dressing 1 is performed by directing one or more UV laser beams 6 toward the second side of the medical dressing 1. A visible mark 5 is formed on a layer of UV-absorbing polymer material in the medical dressing 1. The mark 5 is visible on the second side of the medical dressing 1.

[0132] The polymer material included in one layer of the dressing absorbs UV light and undergoes a photochemical reaction that breaks polymer bonds, thereby producing visible markings on the second side of the dressing.

[0133] As shown in Example 2, no harmful byproducts are formed during the printing process. Therefore, the printed medical dressing 1 can be safely applied to a patient's wounds and / or skin.

[0134] This disclosure is not limited to specific UV laser devices, but can be made using any device known to those skilled in the art.

[0135] The wavelength of UV lasers is typically in the range of 320nm to 380nm, preferably 355nm or about 355nm.

[0136] This method is advantageous because the printing can be precisely controlled, and the markings can be customized to specific and desired locations on the medical dressing. In contrast, conventional ink printing often suffers from skewing issues and the risk of the printed content being altered in subsequent processing steps. Therefore, the method disclosed herein provides a controlled and customized apparatus for printing.

[0137] Furthermore, it eliminates interruptions caused by things like ink ribbon and thermal printhead replacement (or cleaning). Therefore, it provides a faster printing process and allows for the production of more products in the same amount of time.

[0138] UV-absorbing polymer materials strongly absorb UV lasers, which causes the intermolecular or interatomic bonds to break, resulting in visible and permanent markings.

[0139] The method may also include the following steps: a') The medical dressing 1 is arranged in a package 7 comprising at least a front layer 8 and a back layer 9, wherein at least a portion of the front layer 8 is transparent and does not absorb UV, and the medical dressing 1 is arranged in the package 7 such that a second side of the medical dressing 1 is visible through the transparent and UV-non-absorbent portion of the front layer 8, wherein step a') is performed before step b), and step b) is performed by passing one or more UV laser beams 6 through the transparent and UV-non-absorbent portion of the front layer 8.

[0140] Figure 5a and Figure 5b The method of printing is shown through the transparent front layer 8 of the packaging 7.

[0141] The transparent and non-UV-absorbing portion of the front layer 8 remains unaffected by the UV laser beam 6 transmitted through the front layer 8.

[0142] The printed markings are visible through the transparent portion of the front layer 8 of the packaging 7 during storage and transportation.

[0143] The advantage of printing while the dressing remains inside the packaging is that the dressing is protected from potential contaminants or substances during the printing process.

[0144] Typically, the transparent portion of the front layer 8 is larger to increase the flexibility of the printing process and minimize errors during printing.

[0145] Typically, at least 70%, preferably at least 80%, of the front layer 8 is transparent and does not absorb UV.

[0146] Therefore, at least 70%, preferably at least 80%, of the surface area of ​​the front layer 8 is transparent and does not absorb UV.

[0147] Preferably, the entire front layer 8 is transparent and does not absorb UV rays. Figure 5a In the middle, the entire front layer 8 is transparent.

[0148] The package 7 containing the medical dressing 1 (step a') is typically a bag comprising a front layer and a back layer, which are sealed together at peripheral side edges. When the medical dressing 1 is placed in the package 7 (i.e., the bag), at least one side edge is opened to allow the medical dressing 1 to enter. When the medical dressing 1 is to be used and removed from the package 7, the sealed side edge can be torn open (see...). Figure 1 ).

[0149] Packaging 7 can be a bag comprising a front layer 8 and a back layer 9, such as... Figure 1 , Figure 5a and Figure 5b As shown.

[0150] The back layer 9 of the packaging is not limited to a specific material. For example, the back layer 9 may include paper.

[0151] The transparent portion of the front layer 8 is not limited to a specific material, as long as the material is transparent and does not absorb UV. For example, the transparent portion of the front layer 8 can be a laminate comprising multiple layers. For example, the transparent portion of the front layer can include polyethylene terephthalate (PET). The thickness of the transparent front layer can be from 40 μm to 200 μm.

[0152] This method typically includes sealing the front layer 8 and the back layer 9 before step b) of printing the medical dressing 1.

[0153] The front layer 8 and the rear layer 9 are defined by peripheral side edges. Prior to step c) of printing the medical dressing 1, the peripheral side edges of the front layer 8 may be sealed to the peripheral side edges of the rear layer 9.

[0154] The method may also include a step of sterilizing the packaging 7 and the medical dressing 1 before step b) of printing the medical dressing 1.

[0155] Typically, the packaging 7 and the medical dressing 1 are sterilized simultaneously.

[0156] Preferably, the package 7 and the medical dressing 1 are sterilized by ethylene oxide (EtO) sterilization. This sterilization method allows the medical dressing to be sterile in the final packaging because ethylene oxide permeates into the sealing film and cardboard box used to package the dressing.

[0157] Example 1 The dressing samples were marked using a 3-axis UV laser marker (MD-U1020C from Keyence). The UV laser marker... Figure 6 The image is schematically shown (denoted as 13). The wavelength of the UV laser is 355 nm. The 3-axis UV laser marker utilizes an autofocus function, allowing the product to be placed on a reference surface (…). Figure 6 The distance d1 to the surface to be marked is identified by the MD-U unit, and the laser focal length and power are automatically adjusted.

[0158] Figure 6 The distance d1 can be 300mm ± 21mm. The distance d2 can be 330mm.

[0159] The dressing samples tested were: Dressing A: Mepilex® Border Flex (Mölnlycke Health Care), which consists of a beige polyurethane backing layer (thickness: 20 μm), a wound pad, and a wound contact layer containing a silicone adhesive.

[0160] Dressing B: Mepilex® Lite Foam Dressing (Mölnlycke Health Care), which comprises a beige polyurethane foam layer, a wound contact layer including a silicone adhesive, and a polyurethane backing layer thermally laminated onto the polyurethane foam layer.

[0161] Before printing, dressing A is placed in a sealed sterile bag. The sterile bag consists of a back layer (paper) and a transparent front layer (comprising a non-UV-absorbing laminate of polyethylene terephthalate (PET)). Printing is performed through the transparent front layer, through which the backing layer of the dressing is visible and faces the UV laser. During printing, metal weights are used to hold the dressing in place.

[0162] The UV laser marking process is initiated, and the polyurethane backing layer is marked with a 2D code based on 34 variables (0107332430446527172305281020267731) through the transparent front layer. The printed dressing is then applied... Figure 7a As shown in the image. Figure 7b The dressing shown is printed in the same way and also uses the string and variable ABC123.

[0163] Information about the 2D code and string content is inserted into the computer software connected to the MD-U unit.

[0164] Dressing B is printed on the outside of the sterile bag, specifically on the side of the dressing facing the UV laser (i.e., the side away from the wound during use). The dressing is then placed on a reference surface (on... Figure 6 The middle part is marked as 14). Dressing B is marked with a cutting guide mark, such as Figure 7c As shown. 2D CAD software is used to define the cutting guide mark, and the CAD file is inserted into the computer software connected to the MD-U unit.

[0165] like Figures 7a-7c As shown, clear and visible markings are provided on the dressing sample.

[0166] Example 2 Sterile dressing samples were prepared for laboratory testing to investigate whether any harmful substances were generated during the UV laser printing process.

[0167] The dressing sample tested was Mepilex® Border Flex Lite (Mölnlycke Health Care), which consists of a beige polyurethane backing layer (thickness: 20 μm), a wound pad, and a wound contact layer containing a silicone adhesive.

[0168] Printing was performed in the manner described in Example 1; that is, when the dressing sample was placed in a sterile package. This method was used to prevent the sample from being contaminated by any external substances, and thus to determine that all identified substances found on the UV-laser-marked sample (which were not identified on the tested un-UV-laser-marked reference sample) were the result of UV-laser marking of the polyurethane backing layer.

[0169] The polyurethane backing layer (60*60mm) was separated from the rest of the product, weighed, and extracted in dichloromethane in an acoustic bath. The extract was analyzed by gas chromatography-mass spectrometry (GC-MS), with detected compounds identified using the NIST mass spectrometry library. Concentrations were determined using external standards in decane equivalents.

[0170] The characterization results of the organic compounds are shown in Table 1 below.

[0171] Table 1: Characterization of organic compounds in UV laser printed products compared to reference samples

[0172] In conclusion, no harmful substances are generated during the UV laser printing process.

[0173] The terms, definitions, and implementation methods of all aspects of this disclosure are applied to other aspects of this disclosure with the necessary modifications.

[0174] Although this disclosure has been described with reference to specific exemplary embodiments thereof, many different changes, modifications, etc. will become apparent to those skilled in the art.

[0175] By studying the accompanying drawings, this disclosure, and the appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments in practicing this disclosure. Furthermore, in the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude a plurality.

Claims

1. A medical dressing (1) comprising a plurality of layers and having a first side facing a patient's skin or wound and an opposing second side during use, wherein the plurality of layers comprises at least a backing layer (2), an adhesive skin contact layer (3), and an absorbent pad (4) comprising one or more pad-forming layers (4a-4c); the absorbent pad (4) is disposed between the backing layer (2) and the adhesive skin contact layer (3), wherein at least one of the plurality of layers of the medical dressing (1) comprises a UV-absorbing polymer material, characterized in that, The medical dressing (1) includes at least one printed mark (5) visible on the second side of the medical dressing (1), and the printed mark (5) is a UV laser printed mark.

2. The medical dressing (1) according to claim 1, wherein, The layer comprising the UV-absorbing polymer material is one of the pad forming layers (4a-c) or the backing layer (2).

3. The medical dressing (1) according to claim 1 or 2, wherein, The layer comprising the UV-absorbing polymer material also includes pigments.

4. The medical dressing (1) as described in any one of claims 1-3, wherein, The UV-absorbing polymer material is polyurethane, polyamide, or polyethylene.

5. The medical dressing (1) according to any one of the preceding claims, wherein, The layer comprising the UV-absorbing polymer material is the backing layer (2), and the backing layer (2) comprises a polyurethane film.

6. The medical dressing (1) according to any one of the preceding claims, wherein, The layer including the UV-absorbing polymer layer is a pad forming layer (4a-c), and the backing layer (2) is transparent and does not absorb UV.

7. The medical dressing (1) according to any one of the preceding claims, wherein, The at least one printed mark (5) is a graphic element and / or a text element.

8. The medical dressing (1) according to any one of the preceding claims, wherein, The at least one printed mark (5) indicates the proper use or application of the medical dressing (1).

9. The medical dressing (1) according to any one of the preceding claims, wherein, The at least one printed mark (5) is a label readable by electronic devices, preferably a barcode or QR code.

10. The medical dressing (1) according to any one of the preceding claims, wherein, The at least one printed mark (5) is a batch number, production batch number, or national instruction.

11. A method for printing medical dressings, comprising: a) Providing a medical dressing (1) comprising multiple layers and having a first side facing the patient's skin or wound and an opposing second side during use, wherein the multiple layers comprise at least a backing layer (2), an adhesive skin contact layer (3), and an absorbent pad (4) comprising one or more pad-forming layers (4a-c); the absorbent pad (4) is disposed between the backing layer (2) and the adhesive skin contact layer (3), wherein at least one of the multiple layers of the medical dressing (1) comprises a UV-absorbing polymer material. b) Printing the medical dressing (1) by passing one or more UV laser beams (6) toward the second side of the medical dressing (1) such that the UV laser beams (6) form (6) at least one printed mark (5) on the medical dressing (1).

12. The method of claim 11, further comprising the step of: a') The medical dressing (1) is arranged in a package (7) comprising at least a front layer (8) and a back layer (9), wherein at least a portion of the front layer (8) is transparent and does not absorb UV, and the medical dressing (1) is arranged in the package (7) such that a second side of the medical dressing (1) is visible through the transparent and UV-non-absorbing portion of the front layer (8), wherein step a') is performed prior to step b), and wherein step b) is performed by passing one or more UV laser beams (6) through the transparent and UV-non-absorbing portion of the front layer (8).

13. The method according to claim 12, further comprising the step of sterilizing the packaging (7) and the medical dressing (1) prior to step b) of printing the medical dressing.

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