Cover Dressing Material, Kit, and Method of Use
The covered dressing material with extended adhesive layers improves adhesion and barrier properties, extending wear time and reducing infection risk by securing medical devices to the skin and providing a sterile barrier.
Patent Information
- Application Number
- JP2025504462
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-07-28
- Filing Date
- 2023-07-11
- Publication Date
- 2025-07-25
AI Technical Summary
Conventional dressing materials for medical devices inserted through the skin often require early replacement due to issues with adhesion performance and excessive soiling, increasing the risk of infection at the insertion site.
A covered dressing material with a backing and cover film, featuring an adhesive layer that extends beyond the backing perimeter to bond to the skin, and a second adhesive layer to secure the medical device, providing improved adhesion and barrier properties.
The solution enhances wear time and comfort, reducing the need for early replacement and minimizing infection risk by maintaining a sterile barrier against dirt and moisture.
Smart Images

Figure 2025524143000001_ABST
Abstract
Description
Technical Field
[0001] The present disclosure generally relates to a cover dressing material used to cover an insertion site, and more particularly to a cover dressing material for use with a medical device that can be inserted through a patient's skin, a kit including a pair of cover dressing materials, and a method of using the kit.
Background Art
[0002] Medical devices including tubes or cannulas can be used for various purposes such as feeding, ventilation, fluid removal, and / or administration of drugs and fluids to a user. Examples of such medical devices include, for example, central venous catheters, arterial catheters, drain tubes, and the like. The cannula of a medical device may be inserted through a patient's skin at an insertion site. The medical device is typically fixed to the patient (e.g., on the patient's skin) by a fixation device.
[0003] After inserting a cannula through a patient's skin, it may be necessary to cover the insertion site with a dressing material to protect the insertion site from infection. The dressing material can provide a sterile barrier that keeps dirt, bacteria, and moisture away from the insertion site, thereby reducing the risk of infection at the insertion site.
[0004] However, conventional dressing materials may need to be replaced early due to problems with adhesion performance (e.g., lift / roll at the dressing material edge) and / or excessive soiling (e.g., by moisture or external substances accessing the insertion site through channels in the conventional dressing material). The risk of infection can increase each time a conventional dressing material is removed from the insertion site for replacement.
[0005] Accordingly, there is a need for a covered dressing material that provides improved comfort, improved barrier properties, and improved wear time for a patient in use, in order to reduce or prevent the need for early replacement of the covered dressing material. SUMMARY OF THE INVENTION
[0006] In a first aspect, the present disclosure provides a covered dressing material. The covered dressing material includes a backing. The backing includes a first major surface and a second major surface opposite the first major surface. The backing further includes a backing peripheral portion surrounding the first major surface and the second major surface of the backing. The first major surface of the backing defines a dressing material plane. The covered dressing material further includes a cover film attached to the backing. The cover film includes a first major surface and a second major surface opposite the first major surface of the cover film. The second major surface of the cover film faces the first major surface of the backing. The cover film further includes a film peripheral portion surrounding the first major surface and the second major surface of the cover film. The cover film defines a first film portion extending beyond the backing peripheral portion and a second film portion having at least a partially same extent as the backing, and the film peripheral portion corresponding to the first film portion is configured to be at least partially spaced apart from the backing peripheral portion in the dressing material plane. The covered dressing material further includes a first adhesive layer disposed at least partially on at least one of the backing and the cover film. The first adhesive layer defines a first adhesive portion extending beyond the backing peripheral portion in the dressing material plane. The first adhesive portion of the first adhesive layer is configured to at least partially bond to the patient's skin.
[0007] In a second aspect, the present disclosure provides a kit for use with a medical device insertable through a patient's skin at an insertion site. The kit includes a pair of covered dressing materials according to the first aspect.
[0008] In a third aspect, the present disclosure provides a kit for use with a medical device insertable through a patient's skin at an insertion site. The kit includes a first cover dressing material and a second cover dressing material. Each of the first cover dressing material and the second cover dressing material includes a backing. The backing includes a first major surface, a second major surface opposite the first major surface, and a backing peripheral portion surrounding the first major surface and the second major surface of the backing. The first major surface of the backing defines a dressing material plane. Each of the first cover dressing material and the second cover dressing material further includes a cover film. The cover film includes a first major surface, a second major surface on the opposite side of the first major surface and facing the first major surface of the backing, and a film peripheral portion surrounding the first major surface and the second major surface of the cover film. The cover film defines a first film portion extending beyond the backing peripheral portion and a second film portion having at least a partially same extent as the backing, and the film peripheral portion corresponding to the first film portion is at least partially spaced apart from the backing peripheral portion in the dressing material plane. Each of the first cover dressing material and the second cover dressing material further includes a first adhesive layer disposed partially between the first major surface of the backing and the second major surface of the cover film. The first adhesive layer is further disposed at least partially on the second major surface of the cover film corresponding to the first film portion. The first adhesive layer is configured to at least partially bond to the user's skin. Each of the first cover dressing material and the second cover dressing material further includes a second adhesive layer disposed at least partially on the second major surface of the backing. The second adhesive layer is configured to at least partially bond to the medical device.
[0009] In a fourth aspect, the present disclosure provides a method of using the kit of the third aspect. The method includes at least partially bonding the first adhesive layer of the first covered dressing material to the patient's skin such that at least a portion of the backing periphery of the first covered dressing material is disposed adjacent to the insertion site. The method further includes rotating the medical device relative to the insertion site such that the first covered dressing material is folded and the second major surface of the backing faces away from the skin. The method further includes at least partially bonding the first adhesive layer of the second covered dressing material to the patient's skin such that at least a portion of the backing periphery of the second covered dressing material is disposed adjacent to the insertion site and the insertion site is covered together by the first covered dressing material and the second covered dressing material. The method further includes at least partially bonding the second adhesive layer of the first covered dressing material and the second adhesive layer of the second covered dressing material to the medical device and to each other such that the medical device is at least partially disposed between and secured to the first covered dressing material and the second covered dressing material.
[0010] Details of one or more examples of the present disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the present disclosure will become apparent from the description and drawings, and from the claims.
Brief Description of the Drawings
[0011] The exemplary embodiments disclosed herein may be more fully understood in consideration of the following detailed description in connection with the following drawings. The drawings are not necessarily drawn to scale. In particular, the thickness of a particular layer may be exaggerated in its ratio to other particular items for ease of explanation and clarity. Like numbers used in the figures refer to like components. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number.
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Embodiments for Carrying Out the Invention
[0012] In the following description, reference is made to the accompanying drawings which form a part hereof and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and can be made without departing from the scope and spirit of the present disclosure. Accordingly, the following detailed description should not be construed in a limiting sense.
[0013] In the following disclosure, the following definitions are adopted.
[0014] As described herein, all numbers should be considered to be modified by the term "about". As used herein, "a", "an", "the", "at least one", and "one or more" are used interchangeably.
[0015] When used herein as a modifier for a characteristic or attribute, the term "generally" means that the characteristic or attribute is readily recognizable by one of ordinary skill in the art, but does not require absolute precision or complete conformance (e.g., within + / -20% for a quantifiable characteristic) unless specifically defined otherwise.
[0016] The term "substantially" means a high degree of approximation (e.g., within + / -10% for a quantifiable characteristic) unless specifically defined otherwise, but again does not require absolute precision or complete conformance.
[0017] The term "about" means a high degree of approximation (e.g., within + / - 5% for quantifiable characteristics) unless specifically defined otherwise, but does not require absolute precision or exact match here.
[0018] Terms such as same, equal, uniform, constant, exactly, etc. are not required to have absolute precision or exact match, but are understood to be within the normal tolerances or measurement errors applicable to a particular situation.
[0019] As used herein, the terms "first" and "second" are used as identifiers. Thus, such terms should not be construed as limiting the present disclosure. When used with a feature or element, the terms "first" and "second" are interchangeable throughout the various embodiments of the present disclosure.
[0020] As used herein, when a first material is said to be "similar to" a second material, at least 90 wt% of the first and second materials are identical and any variation between the first and second materials is less than about 10 wt% of each of the first and second materials.
[0021] As used herein, "at least one of A and B" should be understood to mean "only A, only B, or both A and B".
[0022] Unless otherwise specified or limited, the terms "attached", "connected", "coupled", and their variations are used broadly and include both direct and indirect attachment, connection, and coupling.
[0023] As used herein, the term "adjacent" refers to elements that are close to each other, usually in contact with each other, but may have intervening elements therebetween.
[0024] As used herein, the term "configured to" is at least as limiting as the term "adapted to" and requires an actual design intent to perform the specified function, rather than merely a physical ability to perform such function.
[0025] As used herein, the term "insertion site" refers to any site or region of a subject into which a tube or cannula is intended to be inserted.
[0026] As used herein, the term "layer" refers to the thickness of a material or blend of materials. The layer may be continuous or discontinuous.
[0027] As used herein, the term "adhesive layer" or "bonding layer" refers to a layer of adhesive material disposed on one or more layers to facilitate adhesion of the one or more layers to each other or to another surface. The adhesive layer may be patterned.
[0028] As used herein, the term "periphery" refers to the edge, perimeter, or outer boundary of a layer. It can be noted that the periphery may be of any shape, including but not limited to triangular, rectangular, octagonal, square, circular, elliptical, trapezoidal, pentagonal, hexagonal, etc.
[0029] As used herein, the term "having the same extent" refers to the relationship between a first layer and a second layer where the length and / or width of the first layer is substantially equal to the respective length and / or width of the second layer.
[0030] The present disclosure relates to a covered dressing material. The covered dressing material includes a backing. The backing includes a first major surface and a second major surface opposite the first major surface. The backing further includes a backing peripheral portion surrounding the first major surface and the second major surface of the backing. The first major surface of the backing defines a dressing material plane. The covered dressing material further includes a cover film attached to the backing. The cover film includes a first major surface and a second major surface opposite the first major surface of the cover film. The second major surface of the cover film faces the first major surface of the backing. The cover film further includes a film peripheral portion surrounding the first major surface and the second major surface of the cover film. The cover film defines a first film portion extending beyond the backing peripheral portion and a second film portion having at least a partially same extent as the backing, and the film peripheral portion corresponding to the first film portion is configured to be at least partially spaced apart from the backing peripheral portion in the dressing material plane. The covered dressing material further includes a first adhesive layer disposed at least partially on at least one of the backing and the cover film. The first adhesive layer defines a first adhesive portion extending beyond the backing peripheral portion in the dressing material plane. The first adhesive portion of the first adhesive layer is configured to at least partially bond to a patient's skin.
[0031] The covered dressing material of the present disclosure may be suitable for use with a medical device insertable through a patient's skin. The covered dressing material may be used, for example, to cover and protect an insertion site, i.e., a site where a tube or cannula of a medical device is inserted through a patient's skin.
[0032] The cover dressing material can protect the insertion site from dirt, bacteria, and moisture. Specifically, the cover film can provide barrier properties that protect the insertion site from dirt, bacteria, and moisture. The cover film can further be suitable and comfortable for long-term wear. At least a portion of the cover film may preferably be optically transparent, thereby enabling inspection of the insertion site without the need to remove the cover dressing material from the patient's skin. Further, the backing can provide mechanical rigidity to the cover dressing material while allowing for conformity to the patient's skin.
[0033] The first adhesive layer may partially adhere the cover dressing material to the patient's skin. The first adhesive layer may include a skin-conforming adhesive and preferably may include an antibacterial agent. The first adhesive layer may further partially adhere the cover dressing material to the medical device. Specifically, the first adhesive layer may partially adhere the cover dressing material to the cannula or tube of the medical device.
[0034] In some cases, the cover dressing material may further include a second adhesive layer that at least partially adheres the cover dressing material to the medical device. The second adhesive layer may partially adhere the cover dressing material to the cannula or tube of the medical device. The second adhesive of the second adhesive layer may preferably include a repositionable adhesive such as one that includes silicone.
[0035] In some cases, a pair of the cover dressing materials of the present disclosure may be used to protect the insertion site. In such cases, the pair of cover dressing materials may be partially adhered to the patient's skin, partially adhered to the medical device, and partially adhered to each other.
[0036] The cover dressing material may be used with a fixation device that fixes and stabilizes a medical device to a patient's skin. The cover dressing material can advantageously fix and stabilize at least a portion of the medical device (e.g., a cannula or tube) at the infusion site.
[0037] Accordingly, the cover dressing material of the present disclosure can provide improved wearing time and comfort for the patient. This can reduce or prevent early replacement of the cover dressing material at the infusion site, thereby reducing the risk of infection at the insertion site.
[0038] Referring now to the drawings, FIG. 1 shows a schematic perspective view of a medical device 10 that can be inserted through the skin 20 of a patient 22. The medical device 10 may include a tube or cannula 16. In FIG. 1, the cannula 16 of the medical device 10 is inserted through the skin 20 of the patient 22 at the insertion site 18.
[0039] The medical device 10 may further include one or more lumens 14 that are in fluid connection with the cannula 16. The one or more lumens 14 are shown partially in FIG. 1. The medical device 10 may further include a hub 12. The hub 12 can at least partially receive the one or more lumens 14 and the cannula 16.
[0040] The medical device 10 shown in FIG. 1 is a central venous catheter (CVC). Alternatively, the medical device 10 may be, for example, an arterial catheter, a drain tube, a peripherally inserted central catheter (PICC), or the like.
[0041] In some cases, the hub 12 can be fixed and stabilized on the skin 20 of the patient 22 by a fixing device (not shown). Further, the insertion site 18 may be covered by a dressing material (not shown in FIG. 1). The dressing material may provide a sterile barrier that protects the insertion site 18 from dirt, bacteria, and moisture, thereby aiming to reduce the risk of infection at the insertion site 18. In some cases, the dressing material may further stabilize the cannula 16 with respect to the insertion site 18.
[0042] FIG. 2A shows a schematic cross-sectional view of a cover dressing material 100 according to an embodiment of the present disclosure. The cover dressing material 100 may be suitable for use with a medical device (e.g., the medical device 10 of FIG. 1) that can be inserted through the skin of a patient (e.g., the skin 20 of the patient 22 of FIG. 1). FIG. 2B shows a schematic exploded cross-sectional view of the cover dressing material 100.
[0043] The cover dressing material 100 defines an x-axis, a y-axis, and a z-axis that are orthogonal to each other. The x-axis is defined along the length of the cover dressing material 100, the y-axis is defined along the width of the cover dressing material 100, and the z-axis is defined along the thickness of the cover dressing material 100.
[0044] Referring to FIGS. 2A and 2B, the cover dressing material 100 includes a backing 110. The backing 110 includes a first major surface 112 and a second major surface 114 opposite the first surface 112. The backing 110 further includes a backing peripheral portion 115 that surrounds the first major surface 112 and the second major surface 114 of the backing 110.
[0045] The first major surface 112 of the backing 110 defines a dressing material plane 116. The dressing material plane 116 is illustratively shown by a line in FIGS. 2A and 2B. The dressing material plane 116 may be substantially parallel to the first major surface 112 of the backing 110. The dressing material plane 116 may be substantially parallel to the x-y plane.
[0046] The backing 110 may include any material that provides mechanical rigidity to the covered dressing material 100 while providing sufficient flexibility to allow for conformity and comfortable wearing. For example, the material of the backing 110 may be a film, paper, or a layer of fabric material such as woven, knitted, or non-woven fabric. The material of the backing 110 may be elastic or rigid.
[0047] In some embodiments, the backing 110 includes a foam or non-woven material. For example, the backing 110 can include a woven material, a knitted material, or a non-woven material. An example of a non-woven material is a high-strength non-woven fabric available under the SONTARA trademark from E.I. Dupont de Nemours & Company (Wilmington, Delaware). Other suitable non-woven materials include, but are not limited to, a hydroentangled polyester fabric available from Vertac, a division of International Paper (Walpole, Minnesota). Another suitable non-woven material is the non-woven elastomeric web described in U.S. Patent No. 5,230,701, which is incorporated herein by reference.
[0048] The backing 110 may be a high water vapor permeable film backing. U.S. Patent No. 3,645,835 describes methods for manufacturing such films and methods for testing their permeability, which are incorporated herein by reference. The backing 110 may have a single-layer or multi-layer structure. In some examples, a reinforcing material may be included in the backing 110. The reinforcing material may be as flexible as a thick adhesive or as hard as a solid material (e.g., paper or film).
[0049] The backing 110 further has a thickness 110T defined between a first major surface 112 and a second major surface 114. The thickness 110T of the backing 110 can be defined perpendicular to the dressing material plane 116 (i.e., along the z-axis). In some embodiments, the thickness 110T of the backing 110 may be from 25 microns to 260 microns (i.e., about 1 mil to about 10 mils). In some embodiments, the thickness 110T of the backing 110 may be from 50 microns to 130 microns.
[0050] The covered dressing material 100 further includes a cover film 120 attached to the backing 110. The cover film 120 may be attached directly (e.g., by stitching, etc.) or indirectly (e.g., via an adhesive) to the backing 110. In the illustrated embodiment of FIG. 2A, the cover film 120 is attached to the backing 110 via an adhesive layer that will be described in more detail later.
[0051] The cover film 120 includes a first major surface 122 and a second major surface 124 opposite the first major surface 122 of the cover film 120. The second major surface 124 of the cover film 120 faces the first major surface 112 of the backing 110. The cover film 120 further includes a film peripheral portion 125 surrounding the first major surface 122 and the second major surface 124 of the cover film 120.
[0052] The cover film 120 defines a first film portion 126 that extends beyond the backing peripheral portion 115 and a second film portion 127 having at least a partially same extent as the backing 110. The film peripheral portion 125 corresponding to the first film portion 126 is adapted to be at least partially spaced apart from the backing peripheral portion 115 in the dressing material plane 116. In other words, at least a portion of the cover film 120 may not have the same extent as the backing 110. The cover film 120 may have dimensions larger than the backing 110 in the dressing material plane 116 (or x-y plane), and the cover film 120 is adapted to define a first film portion 126 that extends beyond the backing peripheral portion 115 of the backing 110.
[0053] In some embodiments, the cover film 120 is optically transparent. In some embodiments, at least the first film portion 126 of the cover film 120 is optically transparent. As a result, the skin of the patient disposed under the first film portion 126 can be viewed through the cover dressing material 100. Thus, the skin disposed under the first film portion 126 can be inspected without the need to remove the cover dressing material 100 from the patient's skin. In some examples, the insertion site (e.g., the insertion site 18 of FIG. 1) can be viewed through the first film portion 126 and thus can be inspected without the need to remove the cover dressing material 100 from the patient's skin. The optically transparent cover film 120 can also facilitate the placement of the cover dressing material 100 over the insertion site during application of the cover dressing material 100.
[0054] The cover film 120 is preferably impermeable to liquids, but may be permeable to water vapor. Further, the cover film 120 may be conformable and elastic. For example, the cover film 120 may conform to a non-planar anatomical surface such as a patient's skin. In some embodiments, the cover film 120 can have an ultimate elongation of greater than 200%. In some embodiments, the cover film 120 can have an ultimate elongation of greater than 400%. Exemplary materials for the cover film 120 can be found, for example, in U.S. Pat. Nos. 5,088,483 and 5,160,315, which are incorporated herein by reference. In some embodiments, the cover film 120 may include an elastomeric polyurethane, a copolyester, or a polyether block amide film. Thus, the cover film 120 can have the desirable properties of conformability, high water vapor permeability, and transparency.
[0055] The cover film 120 has a thickness 120T defined between a first major surface 122 and a second major surface 124. The thickness 120T of the cover film 120 can be defined perpendicular to the dressing material plane 116 (i.e., along the z-axis). In some embodiments, the thickness 120T of the cover film 120 may be from 12 microns to 130 microns (i.e., from about 0.5 mil to about 5 mil). In some embodiments, the thickness 120T of the cover film 120 may be from 25 microns to 100 microns.
[0056] In some embodiments, each of the backing 110 and the cover film 120 is continuous within the dressing material plane 116 and has no through openings. In other words, each of the backing 110 and the cover film 120 may have no macro openings (e.g., openings having a maximum width greater than 1 millimeter). In some embodiments, each of the backing 110 and the cover film 120 includes micro openings that can impart vapor permeability and may have no macro openings. Thus, each of the backing 110 and the cover film 120 may not include macroscopic elements such as windows or screens extending therethrough.
[0057] The covered dressing material 100 further includes a first adhesive layer 130 disposed at least partially on at least one of the backing 110 and the cover film 120. The first adhesive layer 130 defines a first adhesive portion 136 that extends beyond the backing perimeter 115 in the dressing material plane 116. The first adhesive portion 136 of the first adhesive layer 130 is configured to at least partially bond to the skin of a patient (e.g., the skin 20 of patient 22 in FIG. 1).
[0058] In the illustrated embodiment of FIG. 2A, the first adhesive layer 130 is disposed partially between the first major surface 112 of the backing 110 and the second major surface 124 of the cover film 120, and the first adhesive portion 136 is configured to have at least a partially coextensive spread with the first film portion 126 in the dressing material plane 116. Specifically, in the illustrated embodiment of FIG. 2A, the first adhesive layer 130 has the same spread as the second major surface 124 of the cover film 120 in the dressing material plane 116.
[0059] The first adhesive layer 130 may include an adhesive material suitable for application to the skin. The first adhesive layer 130 can include an optically clear adhesive (OCA). The first adhesive layer 130 can include, for example, a pressure-sensitive adhesive (PSA). The pressure-sensitive adhesive may have a relatively high water vapor transmission rate to allow for moisture evaporation. Suitable pressure-sensitive adhesives include those based on acrylates, urethanes, hydrogels, hydrophilic colloids, block copolymers, silicones, rubber-based adhesives (including natural rubber, polyisoprene, polyisobutylene, butyl rubber, etc.), and combinations of these adhesives. The adhesive composition may contain tackifiers, plasticizers, rheology modifiers, and active ingredients. The pressure-sensitive adhesive may be moderately skin-compatible and "low-allergenic," such as the acrylate copolymer described in U.S. Patent No. RE24906. Particularly useful is the 97:3 isooctyl acrylate:acrylamide copolymer, and the same is true for the 70:15:15 isooctyl acrylate:ethylene oxide acrylate:acrylic acid terpolymer described in U.S. Patent No. 4737410. Additional useful adhesives are described in U.S. Patent Nos. 3389827, 4112213, 4310509, and 4323557. In some embodiments, the first adhesive layer 130 includes an antibacterial agent. As described in U.S. Patent Nos. 4310509 and 4323557, it is contemplated to include a drug or antibacterial agent in the first adhesive layer 130.
[0060] In the illustrated embodiment of FIG. 2A, the first adhesive layer 130 has the same extent as the second major surface 124 of the cover film 120. Alternatively, the first adhesive layer 130 does not have the same extent as the second major surface 124 of the cover film 120, and at least a portion of the first adhesive layer 130 may be disposed on the second major surface 124 of the cover film 120 corresponding to the first film portion 126. The first adhesive layer 130 may be substantially continuous or patterned based on the desired application attributes. The patterned first adhesive layer 130 can advantageously improve the vapor transmission rate of the covered dressing material 100.
[0061] The first adhesive layer 130 has a thickness 130T. The thickness 130T of the first adhesive layer 130 can be defined perpendicular to the dressing material plane 116 (i.e., along the z-axis). In some embodiments, the thickness 130T of the first adhesive layer 130 may be from 2.5 microns to 130 microns (i.e., from about 0.1 mil to about 5 mils). In some embodiments, the thickness 130T of the first adhesive layer 130 may be from 5 microns to 50 microns.
[0062] In the illustrated embodiment of FIG. 2A, the covered dressing material 100 further includes a second adhesive layer 140 disposed at least partially on the second major surface 114 of the backing 110. The second adhesive layer 140 can be configured to at least partially couple to a medical device (e.g., the medical device 10 of FIG. 1). Specifically, the second adhesive layer 140 can be configured to at least partially couple to a tube or cannula of the medical device (e.g., the cannula 16 of the medical device 10 of FIG. 1).
[0063] The second adhesive layer 140 may include a repositionable adhesive. Preferably, the second adhesive may be easily removable from the medical device, and the cover dressing 100 may be removable from the patient's skin without the need to remove the medical device from the insertion site. Further, the second adhesive layer 140 may have a low adhesion strength at room temperature (e.g., 27 degrees Celsius).
[0064] In some embodiments, the second adhesive layer 140 may include a pressure-sensitive adhesive. In some embodiments, the second adhesive layer 140 may include silicone. Suitable silicone adhesives are disclosed in International Publication Nos. WO 2010 / 056541 and WO 2010 / 056543, the disclosures of which are incorporated herein by reference. In some embodiments, the second adhesive layer 140 may include an adhesive different from the first adhesive layer 130. In other words, the second adhesive layer 140 may include an adhesive having a composition different from that of the first adhesive layer 130.
[0065] In the illustrated embodiment of FIG. 2A, the second adhesive layer 140 has the same extent as the second major surface 114 of the backing 110. Alternatively, the second adhesive layer 140 may not have the same extent as the second major surface 114 of the backing 110. The second adhesive layer 140 may be substantially continuous or patterned based on the desired application attributes. In some cases, the second adhesive layer 140 may be discontinuous along a portion of the second major surface 114 of the backing 110.
[0066] The second adhesive layer 140 has a thickness 140T. The thickness 140T of the second adhesive layer 140 can be defined perpendicular to the dressing plane 116 (i.e., along the z-axis). In some embodiments, the thickness 140T of the second adhesive layer 140 may be from 2.5 microns to 130 microns (i.e., about 0.1 mil to about 5 mils). In some embodiments, the thickness 140T of the second adhesive layer 140 may be from 5 microns to 50 microns.
[0067] In the illustrated embodiment of FIG. 2A, the cover dressing material 100 further includes a tab 150. The tab 150 may include a first major surface 152 facing the second major surface 114 of the backing 110 and a second major surface 154 opposite the first major surface 152 of the tab 150. The tab 150 can further include a tab peripheral portion 155 surrounding the first major surface 152 and the second major surface 154 of the tab 150.
[0068] The tab 150 further has a thickness 150T. The thickness 150T of the tab 150 can be defined between the first major surface 152 and the second major surface 154 of the tab 150. The thickness 150T of the tab 150 can be defined perpendicular to the dressing material plane 116 (i.e., along the z-axis). In some embodiments, the thickness 150T of the tab 150 may be from 12 microns to 130 microns (i.e., about 0.5 mils to about 5 mils).
[0069] The tab 150 can provide a gripping area that does not include any adhesive, such as the adhesives of the first adhesive layer 130 and the second adhesive layer 140. Specifically, the second major surface 154 of the tab 150 may not include any adhesive. The tab 150 may be gripped by a user to apply the cover dressing material 100 to the patient's skin. Specifically, the second major surface 154 of the tab 150 and the first major surface 122 of the cover film 120 may be gripped by a user to apply the cover dressing material 100 to the patient's skin. However, it can be noted that the tab 150 is optional. For example, when the second adhesive layer 140 has a configuration that provides an adhesive-free area on the second major surface 114 of the backing 110, the tab 150 may be omitted from the cover dressing material 100. Such a configuration will be described in more detail later.
[0070] In the illustrated embodiment of FIG. 2A, the second adhesive layer 140 is partially disposed between the second major surface 114 of the backing 110 and the first major surface 152 of the tab 150. Further, in the illustrated embodiment of FIG. 2A, each of the backing 110 and the second adhesive layer 140 extends beyond the tab peripheral portion 155 such that the backing peripheral portion 115 is at least partially spaced apart from the tab peripheral portion 155 in the dressing material plane 116.
[0071] In some embodiments, the area of the first major surface 112 of the backing 110 is at most 60% of the area of the second major surface 124 of the cover film 120. In some embodiments, the area of the first major surface 112 of the backing 110 is at most 50%, at most 40%, or at most 30% of the area of the second major surface 124 of the cover film 120. Thus, the cover film 120 may be larger in size compared to the backing 110. In some embodiments, the area of the second major surface 154 of the tab is at most 30% of the area of the second major surface 114 of the backing 110. Thus, the backing 110 may be larger in size compared to the tab 150. The cover film 120, the backing 110, and the tab 150 may have dimensions that continuously decrease in the dressing material plane 116.
[0072] In the illustrated embodiment of FIG. 2A, the tab peripheral portion 155 is partially aligned with the backing peripheral portion 115 in the dressing material plane 116. Further, in the illustrated embodiment of FIG. 2A, the backing peripheral portion 115 is partially aligned with the film peripheral portion 125 in the dressing material plane 116. In other words, in the illustrated embodiment of FIG. 2A, the film peripheral portion 125, the backing peripheral portion 115, and the tab peripheral portion 155 are partially aligned with each other and not partially aligned with each other. For example, the film peripheral portion 125, the backing peripheral portion 115, and the tab peripheral portion 155 may be aligned at one end of the covered dressing material 100, but not aligned at the opposite end of the covered dressing material 100.
[0073] In some embodiments, the covered dressing material 100 further includes a release liner 160 that is at least partially and removably adhered to each of the first adhesive layer 130 and the second adhesive layer 140. The release liner 160 is not shown in FIG. 2B for illustrative purposes.
[0074] The release liner 160 can protect the first adhesive layer 130 and the second adhesive layer 140 from unwanted contaminants such as dust and debris before the covered dressing material 100 is applied to the patient's skin. Removal of the release liner 160 can expose at least respective portions of the first adhesive layer 130 and the second adhesive layer 140. In some other embodiments, the covered dressing material 100 may include separate release liners for the first adhesive layer 130 and the second adhesive layer 140. Such a configuration of the release liner will be described in more detail later.
[0075] FIG. 2C shows a schematic top view of the covered dressing material 100 according to an embodiment of the present disclosure. The first adhesive layer 130, the second adhesive layer 140, and the release liner 160 shown in FIG. 2A are not shown in FIG. 2C for illustrative purposes. Further, the backing 110 and the tab 150 are schematically shown in dashed lines in FIG. 2C for illustrative purposes.
[0076] The covered dressing material 100 may have any suitable shape such as circular, oval, rectangular, oblong, polygonal, etc. In the illustrated embodiment of FIG. 2C, the covered dressing material 100 has a substantially rectangular shape including a pair of lateral edges and a pair of longitudinal edges.
[0077] In the illustrated embodiment of FIG. 2C, the cover film 120 has a generally rectangular shape and includes a first lateral edge 121, a second lateral edge 123 opposite the first lateral edge 121, a first longitudinal edge 128, and a second longitudinal edge 129 opposite the first longitudinal edge 128. The first lateral edge 121 and the second lateral edge 123 can extend along the y-axis. The first longitudinal edge 128 and the second longitudinal edge 129 can extend along the x-axis.
[0078] The first lateral edge 121, the second lateral edge 123, the first longitudinal edge 128, and the second longitudinal edge 129 can collectively define a film peripheral portion 125 (shown in FIGS. 2A and 2B). The cover film 120 may define a film length 120L that extends along the first longitudinal edge 128 and the second longitudinal edge 129 of the cover film 120 and between the first lateral edge 121 and the second lateral edge 123.
[0079] In the illustrated embodiment of FIG. 2C, the backing 110 has a substantially rectangular shape and includes a first lateral edge 111, a second lateral edge 113 opposite the first lateral edge 111, a first longitudinal edge 118, and a second longitudinal edge 119 opposite the first longitudinal edge 118. The first lateral edge 111 and the second lateral edge 113 can extend along the y-axis. The first longitudinal edge 118 and the second longitudinal edge 119 can extend along the x-axis. The first lateral edge 111, the second lateral edge 113, the first longitudinal edge 118, and the second longitudinal edge 119 can collectively define a backing peripheral portion 115 (shown in FIGS. 2A and 2B).
[0080] In the illustrated embodiment of FIG. 2C, the second lateral edge 113 of the backing 110 is spaced from the second lateral edge 123 of the cover film 120. Further, in FIG. 2C, the first lateral edge 111, the first longitudinal edge 118, and the second longitudinal edge 119 of the backing 110 are each shown to be slightly misaligned with the first lateral edge 121, the first longitudinal edge 128, and the second longitudinal edge 129 of the cover film 120, respectively, for purposes of illustration only, so as to be able to distinguish the respective first lateral edges from each other. The first lateral edge 111 of the backing 110 may or may not be aligned with the first lateral edge 121 of the cover film 120, the first longitudinal edge 118 of the backing 110 may or may not be aligned with the first longitudinal edge 128 of the cover film 120, and the second longitudinal edge 119 of the backing 110 may or may not be aligned with the second longitudinal edge 129 of the cover film 120. It can be noted that
[0081] The backing 110 may define a backing length 110L that extends along the first longitudinal edge 118 and the second longitudinal edge 119 and between the first lateral edge 111 and the second lateral edge 113 of the backing 110. The backing length 110L may be less than the film length 120L. Specifically, the backing length 110L may be shorter than the film length 120L by a first length difference 105L. In other words, the first length difference 105L may be the difference in length between the film length 120L and the backing length 110L. The first length difference 105L may be, for example, 50% or more of the film length 120L.
[0082] In the illustrated embodiment of FIG. 2C, the tab 150 has a substantially rectangular shape and includes a first lateral edge 151, a second lateral edge 153 opposite the first lateral edge 151, a first longitudinal edge 158, and a second longitudinal edge 159 opposite the first longitudinal edge 158. The first lateral edge 151 and the second lateral edge 153 can extend along the y-axis. The first longitudinal edge 158 and the second longitudinal edge 159 can extend along the x-axis. The first lateral edge 151, the second lateral edge 153, the first longitudinal edge 158, and the second longitudinal edge 159 can collectively define a tab peripheral portion 155 (shown in FIGS. 2A and 2B).
[0083] In the illustrated embodiment of FIG. 2C, the second lateral edge 153 of the tab 150 is spaced from the second lateral edge 113 of the backing 110. Further, in FIG. 2C, the first lateral edge 151, the first longitudinal edge 158, and the second longitudinal edge 159 of the tab 150 are shown to be slightly misaligned with the first lateral edge 121, the first longitudinal edge 128, and the second longitudinal edge 129 of the cover film 120, respectively, for the sake of illustration so as to be distinguishable from each other's first lateral edges. It can be noted that the first lateral edge 151 of the tab 150 may or may not be aligned with the first lateral edge 111 of the backing 110, the first longitudinal edge 158 of the tab 150 may or may not be aligned with the first longitudinal edge 118 of the backing 110, and the second longitudinal edge 159 of the tab 150 may or may not be aligned with the second longitudinal edge 119 of the backing 110. In the illustrated embodiments of FIGS. 2A and 2B, the first lateral edge 111 of the backing 110, the first lateral edge 121 of the cover film 120, and the first lateral edge 151 of the tab 150 are aligned with each other in the dressing material plane 116 (shown by a dashed line in FIG. 2C).
[0084] The tab 150 may define a tab length 150L that extends along the first longitudinal edge 158 and the second longitudinal edge 159 and between the first transverse edge 151 and the second transverse edge 153 of the tab 150. The tab length 150L may be less than the backing length 110L. Specifically, the tab length 150L may be shorter than the backing length 110L by the second length difference 106L. In other words, the second length difference 106L may be the difference in length between the backing length 110L and the tab length 150L. The second length difference 106L may be, for example, 50% or more of the backing length 110L.
[0085] In the illustrated embodiment of FIG. 2B, the first adhesive layer 130 includes the first transverse edge 131 and the second transverse edge 133 on the opposite side of the first transverse edge 131. Further, in the illustrated embodiment of FIG. 2B, the second adhesive layer 140 includes the first transverse edge 141 and the second transverse edge 143 on the opposite side of the first transverse edge 141.
[0086] Referring now to FIGS. 2A-2C, in some embodiments, each of the backing 110, the cover film 120, the first adhesive layer 130, the second adhesive layer 140, and the tab 150 includes respective first lateral edges 111, 121, 131, 141, 151 and respective second lateral edges 113, 123, 133, 143, 153 opposite the respective first lateral edges 111, 121, 131, 141, 151. Further, in some embodiments, the respective first lateral edges 111, 121, 131, 141, 151 of the backing 110, the cover film 120, the first adhesive layer 130, the second adhesive layer 140, and the tab 150 are aligned in the dressing material plane 116. In other words, in some embodiments, the first lateral edge 111 of the backing 110, the first lateral edge 121 of the cover film 120, the first lateral edge 131 of the first adhesive layer 130, and the first lateral edge 141 of the second adhesive layer 140 are aligned with each other in the dressing material plane 116. In some embodiments, the first lateral edge 151 of the tab 150 may also be aligned with the first lateral edge 111 of the backing 110, the first lateral edge 121 of the cover film 120, the first lateral edge 131 of the first adhesive layer 130, and the first lateral edge 141 of the second adhesive layer 140 in the dressing material plane 116.
[0087] Furthermore, in some embodiments, the second lateral edges 113, 123, 133, 143, 153 of the backing 110, cover film 120, first adhesive layer 130, second adhesive layer 140, and tab 150, respectively, are not aligned in the dressing material plane 116. In other words, in some embodiments, the second lateral edge 113 of the backing 110, the second lateral edge 123 of the cover film 120, the second lateral edge 133 of the first adhesive layer 130, and the second lateral edge 143 of the second adhesive layer 140 are not aligned with each other in the dressing material plane 116. In some embodiments, the second lateral edge 153 of the tab 150 may also not be aligned with the second lateral edge 113 of the backing 110, the second lateral edge 123 of the cover film 120, the second lateral edge 133 of the first adhesive layer 130, and the second lateral edge 144 of the second adhesive layer 140 in the dressing material plane 116.
[0088] Figure 3 shows a schematic bottom view of a covered dressing material 170 according to another embodiment of the present disclosure. The covered dressing material 170 is substantially similar to the covered dressing material 100 of FIG. 2A, and like elements are denoted by like reference numerals. The backing 110 and tab 150 (both shown in FIG. 2A) are not shown in FIG. 3 for purposes of illustration. However, the covered dressing material 170 has a first adhesive layer 130 and a second adhesive layer 140 that are different in shape and configuration from the covered dressing material 100 of FIG. 2A.
[0089] Specifically, in the illustrated embodiment of FIG. 3, the covered dressing material 170 has a rectangular shape with rounded edges. In the illustrated embodiment, the cover film 120 has a rectangular shape with rounded edges. However, it can be noted that one or more of the cover film 120, backing 110 (not shown in FIG. 3), first adhesive layer 130, second adhesive layer 140, and tab 150 (not shown in FIG. 3) can have a rectangular shape with rounded edges.
[0090] Furthermore, in the illustrated embodiment of FIG. 3, each of the first adhesive layer 130 and the second adhesive layer 140 is spaced from the film peripheral portion 125 in the dressing material plane 116 (i.e., the x-y plane of FIG. 3).
[0091] FIG. 4 shows a schematic cross-sectional view of a cover dressing material 200 according to another embodiment of the present disclosure. The cover dressing material 200 is similar to the cover dressing material 100 of FIG. 2A, and similar elements are denoted by similar reference numerals. However, the cover dressing material 200 includes a second adhesive layer 140 having a different configuration as compared to the cover dressing material 100 of FIG. 2A. As a result, the tab 150 of the cover dressing material 100 is omitted in the cover dressing material 200.
[0092] In the illustrated embodiment of FIG. 4, the second major surface 114 of the backing 110 includes an adhesive-free region 117 that extends beyond the second adhesive layer 140. In the illustrated embodiment of FIG. 4, the first lateral edge 141 of the second adhesive layer 140 is spaced from the first lateral edge 111 of the backing 110, and the adhesive-free region 117 is configured to be defined by the second major surface 114 of the backing 110.
[0093] The adhesive-free region 117 may be grasped by a user for applying the cover dressing material 200 to the patient's skin. The adhesive-free region 117 can provide a function similar to that of the tab 150 of FIG. 2A. As a result, the adhesive-free region 117 can enable the omission of the tab 150 (shown in FIG. 2A) from the cover dressing material 200.
[0094] In the illustrated embodiment of FIG. 4, the cover dressing material 200 further includes a first release liner 161 that is at least partially and removably adhered to the first adhesive layer 130. By removing the first release liner 161, at least a portion of the first adhesive layer 130 can be exposed. In the illustrated embodiment of FIG. 4, the cover dressing material 200 further includes a second release liner 162 that is at least partially and removably adhered to the second adhesive layer 140. By removing the second release liner 162, at least a portion of the second adhesive layer 140 can be exposed. Thus, respective portions of the first adhesive layer 130 and the second adhesive layer 140 can be selectively exposed by removing the first release liner 161 and the second release liner 162.
[0095] FIG. 5A shows a schematic cross-sectional view of a cover dressing material 250 according to another embodiment of the present disclosure. The cover dressing material 250 is similar to the cover dressing material 100 of FIG. 2A, and like elements are denoted by like reference numerals. However, the cover dressing material 250 has a first adhesive layer 130 configured differently from the first adhesive layer 130 of the cover dressing material 100 of FIG. 2A. Further, the cover dressing material 250 omits the second adhesive layer 140 of the cover dressing material 100 of FIG. 2A. Further, the first adhesive layer 130 is disposed on the cover film 120 such that the cover film 120 is disposed between the backing 110 and the first adhesive layer 130 along the thickness (i.e., z-axis) of the cover dressing material 250.
[0096] In the illustrated embodiment of FIG. 5A, the cover dressing material 250 includes a bonding layer 210 disposed at least partially between the first major surface 112 of the backing 110 and the second major surface 124 of the cover film 120. The bonding layer 210 attaches the cover film 120 to the backing 110. It can be noted that the bonding layer 210 is optional and may be omitted from the cover dressing material 250, for example, if the cover film 120 is attached to the backing 110 by mechanical means such as stitching.
[0097] In the illustrated embodiment of FIG. 5A, the first adhesive layer 130 is at least partially disposed on the first major surface 122 of the cover film 120. Specifically, in the illustrated embodiment of FIG. 5A, the first adhesive layer 130 is disposed on the first major surface 122 of the cover film 120 on the opposite side of the backing 110. Thus, the backing 110 does not include the first adhesive layer 130.
[0098] As described above, the first adhesive layer 130 defines a first adhesive portion 136 that extends beyond the backing peripheral portion 115 in the dressing material plane 116. The first adhesive portion 136 of the first adhesive layer 130 is configured to at least partially bond to the skin of the patient (e.g., the skin 20 of the patient 22 in FIG. 1). In the illustrated embodiment of FIG. 5A, the first adhesive layer 130 further defines a second adhesive portion 137 that has at least partially the same extent as the backing 110 in the dressing material plane 116. In some embodiments, the second adhesive portion 137 is configured to at least partially bond to the medical device 10 (shown in FIG. 1).
[0099] In the illustrated embodiment of FIG. 5A, the covered dressing material 250 further includes a tab 220. In the illustrated embodiment of FIG. 5A, the tab 220 is disposed on the first adhesive layer 130 such that the tab 220 is spaced apart from the first adhesive portion 136 in the dressing material plane 116. In the illustrated embodiment of FIG. 5A, the tab 220 is disposed on the second adhesive portion 137 of the first adhesive layer 130 and is spaced apart from the first adhesive portion 136 in the dressing material plane 116.
[0100] The tab 220 can include a first major surface 222 and a second major surface 224 opposite the first major surface 222 of the tab 220. In the illustrated embodiment of FIG. 5A, the first major surface 222 of the tab 220 faces the first major surface 112 of the cover film 120. The tab 220 can further include a tab peripheral portion 225 surrounding the first major surface 222 and the second major surface 224 of the tab 220. The backing 110 can extend beyond the tab peripheral portion 225 such that the backing peripheral portion 115 is at least partially spaced apart from the tab peripheral portion 225 in the dressing material plane 116. Further, in the illustrated embodiment of FIG. 5A, the tab peripheral portion 225 is partially aligned with the backing peripheral portion 115 in the dressing material plane 116. In some embodiments, the area of the second major surface 224 of the tab 220 is at most 30% of the area of the second major surface 114 of the backing 110.
[0101] The cover dressing material 250 may further include a release liner 230. In the illustrated embodiment of FIG. 5A, the release liner 230 is at least partially and removably adhered to the first adhesive layer 130. Removal of the release liner 230 can expose at least a portion of the first adhesive layer 130.
[0102] FIG. 5B shows a schematic cross-sectional view of a cover dressing material 251 according to another embodiment of the present disclosure. The cover dressing material 251 is substantially similar to the cover dressing material 250 of FIG. 5A, and like elements are indicated by like reference numerals. However, the cover dressing material 251 has a first adhesive layer 130 with a different configuration than the cover dressing material 250.
[0103] Specifically, in the illustrated embodiment of FIG. 5B, the first major surface 122 of the cover film 120 includes an adhesive-free region 201 that extends beyond the first adhesive layer 130. In other words, in the illustrated embodiment of FIG. 5B, the first major surface 122 of the cover film 120 defines an adhesive-free region 201 that does not include the first adhesive layer 130. The adhesive-free region 201 enables the omission of the tab 220 (shown in FIG. 5A) from the cover dressing material 251. As a result, in the illustrated embodiment of FIG. 5B, the cover dressing material 251 omits the tab 220.
[0104] FIG. 6A shows a schematic cross-sectional view of a cover dressing material 270 according to another embodiment of the present disclosure. The cover dressing material 270 is similar to the cover dressing material 250 of FIG. 5A, and like elements are denoted by like reference numerals. However, the cover dressing material 270 has a first adhesive layer 130 configured differently from that of the cover dressing material 250. Further, the first adhesive layer 130 is at least partially disposed on the backing 110 such that the backing 110 is disposed between the cover film 120 and the first adhesive layer 130 along the thickness (i.e., z-axis) of the cover dressing material 270.
[0105] In the illustrated embodiment of FIG. 6A, the first adhesive layer 130 is at least partially disposed on the second major surface 114 of the backing 110. As described above, the first adhesive layer 130 defines a first adhesive portion 136 that extends beyond the backing periphery 115 in the dressing material plane 116. In the illustrated embodiment of FIG. 6A, the first adhesive layer 130 further defines a second adhesive portion 137 having at least partially the same extent as the backing 110.
[0106] In the illustrated embodiment of FIG. 6A, the cover dressing material 270 further includes a tab 220. In the illustrated embodiment of FIG. 6A, the first major surface 222 of the tab 220 faces the second major surface 114 of the backing 110. The cover dressing material 270 may optionally further include a release liner 230.
[0107] FIG. 6B shows a schematic cross-sectional view of a cover dressing material 271 according to another embodiment of the present disclosure. The cover dressing material 271 is similar to the cover dressing material 270 of FIG. 6A, and like elements are indicated by like reference numerals. However, the cover dressing material 271 has a first adhesive layer 130 with a different configuration than the cover dressing material 270.
[0108] Specifically, in the illustrated embodiment of FIG. 6B, the second major surface 114 of the backing 110 includes an adhesive-free region 203 that extends beyond the first adhesive layer 130. In other words, in the illustrated embodiment of FIG. 6B, the second major surface 114 of the backing 110 defines an adhesive-free region 203 that does not include the first adhesive layer 130. The adhesive-free region 203 allows for the omission of the tab 220 (shown in FIG. 6A) from the cover dressing material 271. Thus, in the illustrated embodiment of FIG. 6B, the cover dressing material 271 omits the tab 220.
[0109] FIG. 7 shows a schematic block diagram of a kit 300 for use with a medical device insertable through a patient's skin at an insertion site, according to an embodiment of the present disclosure.
[0110] Kit 300 includes a first covered dressing material 101 and a second covered dressing material 102. Each of the first covered dressing material 101 and the second covered dressing material 102 may be equivalent to the covered dressing material 100 of FIG. 2A, the covered dressing material 170 of FIG. 3, the covered dressing material 200 of FIG. 4, the covered dressing material 250 of FIG. 5A, the covered dressing material 251 of FIG. 5B, the covered dressing material 270 of FIG. 6A, or the covered dressing material 271 of FIG. 6B. In some embodiments, each of the first covered dressing material 101 and the second covered dressing material 102 may be identical to each other. In some other embodiments, the first covered dressing material 101 and the second covered dressing material 102 may be different from each other. For example, in some embodiments, the first covered dressing material 101 may be equivalent to the covered dressing material 100 of FIG. 2A, and the second covered dressing material 102 may be equivalent to the covered dressing material 200 of FIG. 3.
[0111] Referring to FIGS. 2A-4, in some embodiments, each of the first covered dressing material 101 and the second covered dressing material 102 includes a backing 110 including a first major surface 112, a second major surface 114 opposite the first major surface 112, and a backing peripheral portion 115 surrounding the first major surface 112 and the second major surface 114 of the backing 110. The first major surface 112 of the backing 110 defines a dressing material plane 116.
[0112] Furthermore, in some embodiments, each of the first covered dressing material 101 and the second covered dressing material 102 includes a cover film 120 having a first main surface 122, a second main surface 124 that is on the opposite side of the first main surface 122 and faces the first main surface 112 of the backing 110, and a film peripheral portion 125 that surrounds the first main surface 122 and the second main surface 124 of the cover film 120. The cover film 120 defines a first film portion 126 that extends beyond the backing peripheral portion 115 and a second film portion 127 that has at least a partially identical extent as the backing 110, and the film peripheral portion 125 corresponding to the first film portion 126 is at least partially spaced apart from the backing peripheral portion 115 in the dressing material plane 116.
[0113] Furthermore, in some embodiments, each of the first covered dressing material 101 and the second covered dressing material 102 includes a first adhesive layer 130 that is partially disposed between the first main surface 112 of the backing 110 and the second main surface 124 of the cover film 120 and includes a first adhesive. The first adhesive layer 130 is further at least partially disposed on the second main surface 124 of the cover film 120 corresponding to the first film portion 126. The first adhesive layer 130 is configured to at least partially bond to the skin 20 of the patient 22 (shown in FIG. 1).
[0114] Furthermore, in some embodiments, each of the first covered dressing material 101 and the second covered dressing material 102 includes a second adhesive layer 140 that is at least partially disposed on the second main surface 114 of the backing 110. The second adhesive layer 140 is configured to at least partially bond to the medical device 10 (shown in FIG. 1).
[0115] In some embodiments, the kit 300 may further include gloves, a sterilizing material, or a cloth or other absorbent material. The kit 300 may be available to a clinician for use in a sterile package. The first cover dressing material 101 and the second cover dressing material 102 may be readily available to a clinician for application to a patient's skin.
[0116] FIG. 8 shows a flowchart of a method 400 of using the kit 300 of FIG. 7, according to one embodiment of the present disclosure. The method 400 is schematically illustrated in FIGS. 9A-9G. The method 400 will be described with reference to FIGS. 8 and 9A-9G.
[0117] In step 410, the method 400 includes at least partially bonding the first adhesive layer of the first cover dressing material to the skin of the patient such that at least a portion of the backing periphery of the first cover dressing material is disposed adjacent to the insertion site. For example, as shown in FIG. 9A, the method 400 can include at least partially bonding the first adhesive layer 130 of the first cover dressing material 101 to the skin 20 of the patient 22 such that at least a portion of the backing periphery 115 of the first cover dressing material 101 is disposed adjacent to the insertion site 18. The method 400 may further include at least partially bonding the second adhesive layer 140 of the first cover dressing material 101 to the medical device 10.
[0118] In step 420, the method 400 further includes rotating the medical device relative to the insertion site such that the first cover dressing material is folded and the second major surface of the backing faces away from the skin. For example, as shown in FIGS. 9A and 9B, the method 400 can include rotating the medical device 10 relative to the insertion site 18 (e.g., in the direction 109 shown in FIG. 9A) such that the first cover dressing material 101 is folded and the second major surface 114 of the backing 110 faces away from the skin 20 (as shown in FIG. 9B).
[0119] In step 430, method 400 further includes at least partially bonding the first adhesive layer of the second cover dressing material to the patient's skin such that at least a portion of the backing periphery of the second cover dressing material is disposed adjacent to the insertion site and the insertion site is covered together by the first cover dressing material and the second cover dressing material. For example, as shown in FIG. 9C, method 400 includes at least partially bonding the first adhesive layer 130 of the second cover dressing material 102 to the skin 20 of the patient 22 such that at least a portion of the backing periphery 115 of the second cover dressing material 102 is disposed adjacent to the insertion site 18 and the insertion site 18 is covered together by the first cover dressing material 101 and the second cover dressing material 102. It can be noted that the insertion site 18 can be surrounded by the cover film 120 of the first cover dressing material 101 and the cover film 120 of the second cover dressing material 102.
[0120] In step 440, method 400 further includes at least partially bonding the second adhesive layer of the first cover dressing material and the second adhesive layer of the second cover dressing material to the medical device and to each other such that the medical device is at least partially disposed between and fixed to the first cover dressing material and the second cover dressing material. For example, as shown in FIG. 9D, method 400 includes at least partially bonding the second adhesive layer 140 of the first cover dressing material 101 and the second adhesive layer 140 of the second cover dressing material 102 to the medical device 10 and to each other such that the medical device 10 is at least partially disposed between and fixed to the first cover dressing material 101 and the second cover dressing material 102. The first cover dressing material 101 and the second cover dressing material 102 may be at least partially wrapped around the medical device 10 such that the second adhesive layer 140 of the first cover dressing material 101 and the second adhesive layer 140 of the second cover dressing material 102 can bond to each other.
[0121] In some embodiments, method 400 further includes removing a second adhesive layer of the second cover dressing material from the medical device and a second adhesive layer of the first cover dressing material. For example, as shown in FIG. 9E, method 400 can include removing a second adhesive layer 140 of the second cover dressing material 102 from the medical device 10 and a second adhesive layer 140 of the first cover dressing material 101. The second adhesive of the second adhesive layer 140 can facilitate removal of the second adhesive layer 140 of the second cover dressing material 102 from the medical device 10 and the second adhesive layer 140 of the first cover dressing material 101.
[0122] In some embodiments, method 400 further includes removing a first adhesive layer of the second cover dressing material from the patient's skin. For example, as shown in FIG. 9F, method 400 may include removing a first adhesive layer 130 of the second cover dressing material 102 from the skin 20 of patient 22.
[0123] In some embodiments, method 400 further includes removing a second adhesive layer of the second cover dressing material from the medical device. For example, as shown in FIG. 9F, method 400 may include removing a second adhesive layer 140 of the second cover dressing material 102 from the medical device 10.
[0124] In some embodiments, method 400 further includes removing a first adhesive layer of the first cover dressing material from the patient's skin. For example, as shown in FIG. 9G, method 400 may include removing a first adhesive layer 130 of the first cover dressing material 101 from the skin 20 of patient 22.
[0125] Method 400 can enable a clinician to apply the first cover dressing material 101 and the second cover dressing material 102 to the skin 20 of patient 22 (shown in FIG. 1) using kit 300. Thus, the first cover dressing material 101 and the second cover dressing material 102 can be used to cover the insertion site 18, keep the insertion site 18 clean, and protect it from bacteria and moisture, thereby reducing the risk of infection at the insertion site 18. Method 400 can further enable a clinician to remove the first cover dressing material 101 and the second cover dressing material 102 from the skin 20 of patient 22 using kit 300.
[0126] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are subject to change depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings of the present disclosure.
[0127] Although specific embodiments have been illustrated and described herein, it will be understood by those skilled in the art that various alternative and / or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Accordingly, it is intended that the present disclosure be limited only by the claims and their equivalents.
Claims
1. A backing including a first major surface, a second major surface opposite the first major surface, and a backing peripheral portion surrounding the first major surface and the second major surface of the backing, wherein the first major surface of the backing defines a dressing material plane, the backing; A cover film including a first major surface, a second major surface on the opposite side of the first major surface and facing the first major surface of the backing, and a film peripheral portion surrounding the first major surface and the second major surface of the cover film, defining a first film portion extending beyond the backing peripheral portion and a second film portion having at least a partially same extent as the backing, and the film peripheral portion corresponding to the first film portion being at least partially spaced apart from the backing peripheral portion in the dressing material plane, the cover film; A first adhesive layer at least partially disposed on at least one of the backing and the cover film, the first adhesive layer defining a first adhesive portion extending beyond the backing peripheral portion in the dressing material plane, and the first adhesive portion of the first adhesive layer being configured to at least partially bond to a patient's skin, the first adhesive layer; A covered dressing material comprising the above.
2. The covered dressing material according to claim 1, wherein the first adhesive layer is at least partially disposed on the first major surface of the cover film.
3. The covered dressing material according to claim 1, wherein the first adhesive layer further defines a second adhesive portion having at least a partially same extent as the backing in the dressing material plane, and the second adhesive portion is configured to at least partially bond to a medical device.
4. The covered dressing material according to claim 1, further comprising a bonding layer at least partially disposed between the first major surface of the backing and the second major surface of the cover film, the bonding layer attaching the cover film to the backing.
5. The covered dressing material according to claim 1, wherein the first adhesive layer is at least partially disposed on the second major surface of the backing.
6. Further comprising a tab disposed on the first adhesive layer, the tab being spaced apart from the first adhesive portion in the dressing material plane, the tab including a first main surface, a second main surface opposite the first main surface of the tab, and a tab peripheral portion surrounding the first main surface and the second main surface of the tab, the backing extending beyond the tab peripheral portion, and the backing peripheral portion being at least partially spaced apart from the tab peripheral portion in the dressing material plane. The covered dressing material according to claim 1.
7. The covered dressing material according to claim 6, wherein the tab peripheral portion is partially aligned with the backing peripheral portion in the dressing material plane.
8. The covered dressing material according to claim 6, wherein the area of the second main surface of the tab is at most 30% of the area of the second main surface of the backing.
9. Further comprising a release liner at least partially and removably adhered to the first adhesive layer, removal of the release liner exposing at least a portion of the first adhesive layer. The covered dressing material according to claim 1.
10. The first adhesive layer is partially disposed between the first main surface of the backing and the second main surface of the cover film, and the first adhesive portion has at least a partially the same spread as the first film portion in the dressing material plane. The covered dressing material according to claim 1.
11. Further comprising a second adhesive layer at least partially disposed on the second main surface of the backing, the second adhesive layer being configured to at least partially bond to a medical device. The covered dressing material according to claim 1.
12. The covered dressing material according to claim 11, wherein the first adhesive layer has the same spread as the second main surface of the cover film.
13. The covered dressing material according to claim 11, wherein the second adhesive layer has the same spread as the second main surface of the backing.
14. The covered dressing material according to claim 11, wherein the second adhesive layer comprises a silicone adhesive.
15. The cover dressing material according to claim 11, wherein the second main surface of the backing includes an adhesive-free region extending beyond the second adhesive layer.
16. The cover dressing material according to claim 11, further comprising a release liner at least partially and removably adhered to each of the first adhesive layer and the second adhesive layer, and removal of the release liner exposes at least respective portions of the first adhesive layer and the second adhesive layer.
17. A first release liner at least partially and removably adhered to the first adhesive layer, wherein removal of the first release liner exposes at least a portion of the first adhesive layer, the first release liner; A second release liner at least partially and removably adhered to the second adhesive layer, wherein removal of the second release liner exposes at least a portion of the second adhesive layer, the second release liner; The cover dressing material according to claim 11, further comprising.
18. A tab, including a first main surface facing the second main surface of the backing, a second main surface opposite to the first main surface of the tab, and a tab peripheral portion surrounding the first main surface and the second main surface of the tab. The cover dressing material according to claim 11, further comprising a tab, each of the backing and the second adhesive layer extending beyond the tab peripheral portion, and the backing peripheral portion being at least partially spaced apart from the tab peripheral portion in the dressing material plane, and the second adhesive layer being partially disposed between the second main surface of the backing and the first main surface of the tab.
19. The cover dressing material according to claim 18, wherein the tab peripheral portion is partially aligned with the backing peripheral portion in the dressing material plane.
20. Each of the backing, the cover film, the first adhesive layer, the second adhesive layer, and the tab includes a respective first lateral edge and a respective second lateral edge opposite the respective first lateral edge, and the respective first lateral edges of the backing, the cover film, the first adhesive layer, the second adhesive layer, and the tab are aligned in the dressing material plane. The covered dressing material according to claim 18.
21. The covered dressing material according to claim 1, wherein the second main surface of the backing includes an adhesive-free region extending beyond the first adhesive layer.
22. The covered dressing material according to claim 1, wherein the first main surface of the cover film includes an adhesive-free region extending beyond the first adhesive layer.
23. The covered dressing material according to claim 1, wherein the peripheral portion of the backing is partially aligned with the peripheral portion of the film in the dressing material plane.
24. The covered dressing material according to claim 1, wherein the area of the first main surface of the backing is at most 60% of the area of the second main surface of the cover film.
25. The covered dressing material according to claim 1, wherein the cover film is optically transparent.
26. The covered dressing material according to claim 1, wherein the backing includes a foam or non-woven material.
27. The covered dressing material according to claim 1, wherein the first adhesive layer includes an antibacterial agent.
28. The covered dressing material according to claim 1, wherein each of the backing and the cover film is continuous within the dressing material plane and has no through openings.
29. A kit for use with a medical device insertable through a patient's skin at an insertion site, the kit comprising a pair of covered dressing materials according to claim 1.
30. A kit for use with a medical device insertable through a patient's skin at an insertion site, the kit comprising a first covered dressing material and a second covered dressing material, each of the first covered dressing material and the second covered dressing material being A backing including a first major surface, a second major surface opposite the first major surface, and a backing peripheral portion surrounding the first major surface and the second major surface of the backing, wherein the first major surface of the backing defines a dressing material plane, the backing; A cover film including a first major surface, a second major surface on the opposite side of the first major surface and facing the first major surface of the backing, and a film peripheral portion surrounding the first major surface and the second major surface of the cover film, defining a first film portion extending beyond the backing peripheral portion and a second film portion having at least a partially the same extent as the backing, and the film peripheral portion corresponding to the first film portion is at least partially spaced apart from the backing peripheral portion in the dressing material plane, the cover film; A first adhesive layer partially disposed between the first major surface of the backing and the second major surface of the cover film, and further at least partially disposed on the second major surface of the cover film corresponding to the first film portion, and configured to at least partially bond to the skin of the patient, the first adhesive layer; A second adhesive layer at least partially disposed on the second major surface of the backing, and configured to at least partially bond to the medical device, the second adhesive layer; Comprising A kit.
31. A method of using the kit according to claim 30, At least partially bonding the first adhesive layer of the first cover dressing material to the skin of the patient such that at least a portion of the backing peripheral portion of the first cover dressing material is disposed adjacent to the insertion site; Rotating the medical device relative to the insertion site such that the first cover dressing material is folded and the second major surface of the backing faces away from the skin; At least a part of the peripheral portion of the backing of the second covered dressing material is disposed adjacent to the insertion site, and the first adhesive layer of the second covered dressing material is at least partially bonded to the skin of the patient such that the insertion site is covered together by the first covered dressing material and the second covered dressing material. The medical device is at least partially disposed between the first covered dressing material and the second covered dressing material, and the second adhesive layer of the first covered dressing material and the second adhesive layer of the second covered dressing material are at least partially bonded to the medical device and to each other so as to be fixed to the first covered dressing material and the second covered dressing material. A method comprising.
32. Removing the second adhesive layer of the second covered dressing material from the medical device and the second adhesive layer of the first covered dressing material. Removing the first adhesive layer of the second covered dressing material from the skin of the patient. Removing the second adhesive layer of the second covered dressing material from the medical device. Removing the first adhesive layer of the first covered dressing material from the skin of the patient. The method according to claim 31, further comprising.