Covering dressings, kits and methods of use
By designing a cover dressing with an adhesive layer, the problem of conventional dressings being susceptible to infection during use is solved, achieving longer coverage and lower risk of infection.
Patent Information
- Application Number
- CN202380056090.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-07-28
- Filing Date
- 2023-07-11
- Publication Date
- 2025-02-28
AI Technical Summary
During use, conventional dressings are susceptible to infection due to adhesion performance problems and excessive contamination, and the covering dressing needs to be replaced too early, increasing the risk of infection.
A covering dressing is designed, including a backing and a covering film, with an adhesive layer attached to the patient's skin and medical device, providing extended coverage and fixation.
Improves the comfort and barrier properties of the covering dressing, extends coverage time, reduces infection risk, and avoids the need for premature replacement.
Smart Images

Figure CN119546261A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates generally to cover dressings for covering an insertion site, and particularly to cover dressings for use with medical devices insertable through the skin of a patient, kits including a pair of cover dressings, and methods of using the kits. Background Art
[0002] Medical devices including tubes or cannulas can be used for various purposes, such as feeding, air supply, fluid removal, and / or administering drugs and fluids to a user. Such medical devices include, for example, central venous catheters, arterial catheters, drainage tubes, etc. The cannula of the medical device can be inserted through the patient's skin at an insertion site. The medical device is typically secured to the patient (e.g., on the patient's skin) by a securing device.
[0003] After the cannula is inserted through the patient's skin, the insertion site may need to be covered by a dressing to protect the insertion site from infection. The dressing 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 dressings may need to be changed prematurely due to adhesion performance issues (e.g., dressing edge lifting / rolling) and / or excessive contamination (e.g., due to moisture or foreign material entering the insertion site through channels in the conventional dressing). Whenever a conventional dressing is removed from the insertion site for the purpose of changing, the risk of infection may increase.
[0005]
[0006] Therefore, there is a need for a cover dressing that provides improved comfort to the patient during use, improved barrier properties, and improved wear time so as to reduce or prevent the need to change the cover dressing prematurely. Summary of the invention
[0006] In a first aspect, the present disclosure provides a covering dressing. The covering dressing includes a backing. The backing includes a first major surface and a second major surface opposite to the first major surface. The backing also includes a backing perimeter surrounding the first major surface and the second major surface of the backing. The first major surface of the backing defines a dressing plane. The covering dressing also includes a covering film attached to the backing. The covering film includes a first major surface and a second major surface opposite to the first major surface of the covering film. The second major surface of the covering film faces the first major surface of the backing. The covering film also includes a film perimeter surrounding the first major surface and the second major surface of the covering film. The covering film defines a first film portion extending beyond the backing perimeter and a second film portion at least partially coextensive with the backing, so that the film perimeter corresponding to the first film portion is at least partially spaced apart from the backing perimeter in the dressing plane. The covering dressing also includes a first adhesive layer at least partially disposed on at least one of the backing and the covering film. The first adhesive layer defines a first adhesive portion extending beyond the backing perimeter in the dressing 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 the skin of a patient at an insertion site. The kit comprises a pair of cover dressings according to the first aspect.
[0008] In a third aspect, the present disclosure provides a kit for use with a medical device that can be inserted through the skin of a patient at an insertion site. The kit includes a first cover dressing and a second cover dressing. Each of the first cover dressing and the second cover dressing includes a backing. The backing includes a first major surface, a second major surface opposite to the first major surface, and a backing periphery surrounding the first major surface and the second major surface of the backing. The first major surface of the backing defines a dressing plane. Each of the first cover dressing and the second cover dressing also includes a cover film. The cover film includes a first major surface, a second major surface opposite to the first major surface and facing the first major surface of the backing, and a film periphery 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 periphery and a second film portion at least partially coextensive with the backing, so that the film periphery corresponding to the first film portion is at least partially spaced apart from the backing periphery in the dressing plane. Each of the first cover dressing and the second cover dressing also includes a first adhesive layer partially disposed between the first major surface of the backing and the second major surface of the cover film. The first adhesive layer is also at least partially disposed 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 and the second cover dressing also includes a second adhesive layer at least partially disposed 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 a first adhesive layer of a first cover dressing to the patient's skin such that at least a portion of a perimeter of a backing of the first cover dressing is disposed adjacent to an insertion site. The method also includes rotating the medical device relative to the insertion site such that the first cover dressing is folded and the second major surface of the backing faces away from the skin. The method also includes at least partially bonding a first adhesive layer of a second cover dressing to the patient's skin such that at least a portion of a perimeter of a backing of the second cover dressing is disposed adjacent to the insertion site, and the insertion site is covered together by the first cover dressing and the second cover dressing. The method also includes at least partially bonding a second adhesive layer of the first cover dressing and a second adhesive layer of the second cover dressing to the medical device and to each other such that the medical device is at least partially disposed between the first cover dressing and the second cover dressing and is secured to the first cover dressing and the second cover dressing.
[0010] The details of one or more examples of the present disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the present disclosure will be 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 by considering the following detailed description in conjunction with the following drawings. The drawings are not necessarily drawn to scale. Specifically, the thickness of certain layers that are proportional to certain other items are exaggerated for ease of illustration and clarity. The same numbers used in the drawings represent similar components. However, it should be understood that the use of numbers to refer to components in a given figure is not intended to limit the components marked with the same number in another figure.
[0012] Figure 1 is a schematic perspective view of a medical device inserted through the skin of a patient;
[0013] Figure 2A is a schematic cross-sectional view of a cover dressing according to one embodiment of the present disclosure;
[0014] Figure 2B According to one embodiment of the present disclosure Figure 2A A schematic exploded cross-sectional view of a cover dressing of , wherein some elements are not shown;
[0015] Figure 2C is a schematic top view of a cover dressing according to one embodiment of the present disclosure, wherein some elements are not shown;
[0016] Figure 3 is a schematic bottom view of a cover dressing according to one embodiment of the present disclosure, with some elements not shown;
[0017] Figure 4 is a schematic cross-sectional view of a cover dressing according to another embodiment of the present disclosure;
[0018] Figure 5A is a schematic cross-sectional view of a cover dressing according to another embodiment of the present disclosure;
[0019] Figure 5B is a schematic cross-sectional view of a cover dressing according to another embodiment of the present disclosure;
[0020] Fig. 6A is a schematic cross-sectional view of a cover dressing according to another embodiment of the present disclosure;
[0021] Figure 6B is a schematic cross-sectional view of a cover dressing according to another embodiment of the present disclosure;
[0022] Figure 7 is a schematic block diagram of a kit according to one embodiment of the present disclosure;
[0023] Figure 8 is a diagram depicting the use of an embodiment according to the present disclosure Figure 7 a flow chart of the various steps of the method of the kit; and
[0024] FIG. 9A to FIG. 9G Schematically shows an embodiment according to the present disclosure Figure 8 method. DETAILED DESCRIPTION
[0025] In the following description, reference is made to the accompanying drawings which form a part thereof, and in which various embodiments are shown by way of illustration. It should be understood that other embodiments are contemplated and may be made without departing from the scope or essence of the present disclosure. Therefore, the following detailed description should not be construed in a limiting sense.
[0026] In the following disclosure, the following definitions apply.
[0027] As used 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.
[0028] As used herein as a modifier of a property or attribute, unless otherwise specifically defined, the term "substantially" means that the property or attribute would be readily recognized by a skilled artisan but does not require absolute precision or a perfect match (e.g., within + / - 20% for a quantifiable property).
[0029] Unless specifically defined otherwise, the term "substantially" means a high degree of approximation (eg, within + / - 10% for a quantifiable property), but likewise does not require absolute precision or a perfect match.
[0030] Unless specifically defined otherwise, the term "about" means a close approximation (eg, within + / - 5% for a quantifiable property), but again does not require absolute precision or a perfect match.
[0031] Terms such as same, equal, consistent, constant, exact, etc. are to be understood as within the usual tolerances or measurement errors applicable to the particular situation, without requiring absolute precision or a perfect match.
[0032] As used herein, the terms "first" and "second" are used as identifiers. Therefore, such terms should not be interpreted as limiting the present disclosure. The terms "first" and "second" are interchangeable in embodiments of the present disclosure when used in conjunction with features or elements.
[0033] As used herein, when a first material is referred to as being "similar" to a second material, at least 90 weight percent of the first and second materials are identical, and any variation between the first and second materials comprises less than about 10 weight percent of each of the first and second materials.
[0034] As used herein, “at least one of A and B” should be understood to mean “only A, only B, or both A and B”.
[0035] Unless specified or limited otherwise, the terms "attached," "connected," "coupled" and variations thereof are used broadly and encompass direct and indirect attachments, connections, and couplings.
[0036] As used herein, the term "adjacent" refers to elements that are close to each other, typically contacting each other, but may have intervening elements between them.
[0037] As used herein, the term "configured to" is at least as restrictive as the term "adapted to," and requires actual design intent to perform the specified function, not merely the physical ability to perform such a function.
[0038] As used herein, the term "insertion site" refers to any site or area of a subject into which a tube or cannula is intended to be inserted.
[0039] As used herein, the term "layer" refers to the thickness of a material or blend of materials. A layer may be continuous or discontinuous.
[0040] 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.
[0041] As used herein, the term "periphery" refers to the border, circumference or outer boundary of a layer. It can be noted that the perimeter can be any shape, such as but not limited to triangle, rectangle, octagon, square, circle, ellipse, trapezoid, pentagon, hexagon, etc.
[0042] As used herein, the term "coextensive" refers to a relationship between a first layer and a second layer wherein a length and / or width of the first layer is substantially equal to a corresponding length and / or width of the second layer.
[0043] The present disclosure relates to a covering dressing. The covering dressing includes a backing. The backing includes a first major surface and a second major surface opposite to the first major surface. The backing also includes a backing perimeter surrounding the first major surface and the second major surface of the backing. The first major surface of the backing defines a dressing plane. The covering dressing also includes a covering film attached to the backing. The covering film includes a first major surface and a second major surface opposite to the first major surface of the covering film. The second major surface of the covering film faces the first major surface of the backing. The covering film also includes a film perimeter surrounding the first major surface and the second major surface of the covering film. The covering film defines a first film portion extending beyond the backing perimeter and a second film portion at least partially coextensive with the backing, so that the film perimeter corresponding to the first film portion is at least partially spaced apart from the backing perimeter in the dressing plane. The covering dressing also includes a first adhesive layer at least partially disposed on at least one of the backing and the covering film. The first adhesive layer defines a first adhesive portion extending beyond the backing perimeter in the dressing plane. The first adhesive portion of the first adhesive layer is configured to at least partially bond to the patient's skin.
[0044] The cover dressing of the present disclosure may be suitable for use with a medical device that can be inserted through the patient's skin. The cover dressing may be used, for example, to cover and protect an insertion site, ie, a site where a tube or cannula of a medical device is inserted through the patient's skin.
[0045] The covering dressing can protect the insertion site from dirt, bacteria, and moisture. Specifically, the covering film can provide barrier properties that protect the insertion site from dirt, bacteria, and moisture. The covering film can also be conformable and comfortable to wear for long periods of time. At least a portion of the covering film can preferably be optically transparent, allowing inspection of the insertion site without removing the covering dressing from the patient's skin. In addition, the backing can provide mechanical rigidity to the covering dressing while allowing conformability to the patient's skin.
[0046] The first adhesive layer may partially adhere the cover dressing to the patient's skin. The first adhesive layer may include a skin-compatible adhesive and may preferably include an antimicrobial agent. The first adhesive layer may also partially adhere the cover dressing to the medical device. Specifically, the first adhesive layer may partially adhere the cover dressing to the cannula or tube of the medical device.
[0047] In some cases, the cover dressing may further include a second adhesive layer that at least partially adheres the cover dressing to the medical device. The second adhesive layer may partially adhere the cover dressing to the cannula or tube of the medical device. The second adhesive of the second adhesive layer may preferably comprise a repositionable adhesive, such as those comprising silicone.
[0048] In some cases, a pair of cover dressings of the present disclosure can be used to protect the insertion site. In this case, the pair of cover dressings can be partially adhered to the patient's skin, partially adhered to the medical device, and partially adhered to each other.
[0049] The cover dressing may be used with a fixation device that fixes and stabilizes the medical device to the patient's skin. The cover dressing may advantageously fix and stabilize at least a portion of a medical device (eg, a cannula or tube) at the injection site.
[0050] Therefore, the cover dressing of the present disclosure can provide improved wearing time and comfort for patients. This can reduce or prevent premature replacement of the cover dressing at the injection site, thereby reducing the risk of infection at the insertion site.
[0051] Now refer to the accompanying drawings, Figure 1 A schematic perspective view of a medical device 10 that can be inserted through the skin 20 of a patient 22 is shown. The medical device 10 may include a tube or cannula 16. Figure 1 In the embodiment shown in FIG. 1 , a cannula 16 of a medical device 10 is inserted through the skin 20 of a patient 22 at an insertion site 18 .
[0052] The medical device 10 may also include one or more lumens 14 in fluid communication with the cannula 16. The one or more lumens 14 may be provided at Figure 1 The medical device 10 may further include a hub 12 . The hub 12 may at least partially receive one or more lumens 14 and a cannula 16 .
[0053] Figure 1 The medical device 10 shown is a central venous catheter (CVC). Alternatively, the medical device 10 may be, for example, an arterial catheter, a drainage tube, a peripherally inserted central catheter (PICC), or the like.
[0054] In some cases, the interface portion 12 may be secured and stabilized on the skin 20 of the patient 22 by a securing device (not shown). In addition, the insertion site 18 may be secured by a dressing (in Figure 1 The dressing may be intended to provide a sterile barrier that protects the insertion site 18 from dirt, bacteria, and moisture, thereby reducing the risk of infection at the insertion site 18. In some cases, the dressing may also stabilize the cannula 16 relative to the insertion site 18.
[0055] Figure 2A 1 shows a schematic cross-sectional view of a cover dressing 100 according to one embodiment of the present disclosure. The cover dressing 100 may be adapted to be attached to a tissue that can penetrate the patient's skin (e.g., Figure 1 A medical device (e.g., Figure 1 The invention is used together with a medical device 10). Figure 2B A schematic exploded cross-sectional view of the cover dressing 100 is shown.
[0056] The cover dressing 100 defines mutually orthogonal x-axis, y-axis and z-axis. The x-axis is defined along the length of the cover dressing 100, while the y-axis is defined along the width of the cover dressing 100. The z-axis is defined along the thickness of the cover dressing 100.
[0057] See also Figure 2A and Figure 2B , the cover dressing 100 includes a backing 110. The backing 110 includes a first major surface 112 and a second major surface 114 opposite to the first major surface 112. The backing 110 also includes a backing perimeter 115 surrounding the first major surface 112 and the second major surface 114 of the backing 110.
[0058] The first major surface 112 of the backing 110 defines a dressing plane 116. The dressing plane 116 is Figure 2A and Figure 2B The dressing plane 116 can be substantially parallel to the first major surface 112 of the backing 110. The dressing plane 116 can be substantially parallel to the xy plane.
[0059] The backing 110 may comprise any material that provides mechanical stiffness to the cover dressing 100 while providing sufficient flexibility to allow conformability and comfortable wearing. For example, the material of the backing 110 may be a film, paper, or a fabric layer material, such as a woven fabric, a knitted fabric, or a nonwoven fabric. The material of the backing 110 may be elastic or rigid.
[0060] In some embodiments, the backing 110 comprises a foam or a nonwoven material. For example, the backing 110 may comprise a woven material, a knitted material, or a nonwoven material. An example of a nonwoven material is a high-strength nonwoven fabric purchased from EI Dupont de Nemours & Company of Wilmington, Delaware under the trademark SONTARA. Other suitable nonwoven materials include, but are not limited to, spunlace polyester fabrics available from Vertac, an international paper division of Walpole, Minnesota. Another suitable nonwoven material is a nonwoven elastomeric fiber web described in U.S. Patent No. 5,230,701 (which is incorporated herein by reference).
[0061] Backing 110 can be a high moisture vapor permeability film backing. U.S. Patent No. 3,645,835 describes methods for preparing such films and methods for testing their permeability and is incorporated herein by reference. Backing 110 can have a single layer or multilayer construction. In some examples, backing 110 can include reinforcing materials. Reinforcing materials can be as flexible as thick adhesives or as hard as solid materials (e.g., paper or films).
[0062] The backing 110 also includes a thickness 110T defined between the first major surface 112 and the second major surface 114. The thickness 110T of the backing 110 can be defined perpendicular to the dressing plane 116 (i.e., along the z-axis). In some embodiments, the thickness 110T of the backing 110 can be 25 microns to 260 microns (i.e., about 1 mil to about 10 mils). In some embodiments, the thickness 110T of the backing 110 can be 50 microns to 130 microns.
[0063] The cover dressing 100 also includes a cover film 120 attached to the backing 110. The cover film 120 can be attached to the backing 110 directly (e.g., sutures, etc.) or indirectly (e.g., via an adhesive). Figure 2A In the illustrated embodiment, the cover film 120 is attached to the backing 110 via an adhesive layer, which will be described in more detail below.
[0064] Cover film 120 includes a first major surface 122 and a second major surface 124 opposite first major surface 122 of cover film 120. Second major surface 124 of cover film 120 faces first major surface 112 of backing 110. Cover film 120 also includes a film perimeter 125 surrounding first major surface 122 and second major surface 124 of cover film 120.
[0065] The cover film 120 defines a first film portion 126 extending beyond the backing perimeter 115 and a second film portion 127 at least partially coextensive with the backing 110, such that the film perimeter 125 corresponding to the first film portion 126 is at least partially spaced apart from the backing perimeter 115 in the dressing plane 116. In other words, at least a portion of the cover film 120 may not be coextensive with the backing 110. The cover film 120 may have a larger dimension than the backing 110 in the dressing plane 116 (or xy plane) such that the cover film 120 defines a first film portion 126 extending beyond the backing perimeter 115 of the backing 110.
[0066] 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 patient's skin disposed below the first film portion 126 is visible through the cover dressing 100. Therefore, the skin disposed below the first film portion 126 can be inspected without having to remove the cover dressing 100 from the patient's skin. In some examples, the insertion site (e.g., Figure 1 The insertion site 18) is visible through the first film portion 126 and can therefore be inspected without having to remove the cover dressing 100 from the patient's skin. During application of the cover dressing 100, the optically transparent cover film 120 can also facilitate positioning of the cover dressing 100 relative to the insertion site.
[0067] The covering film 120 may preferably be impermeable to liquids but permeable to moisture. In addition, the covering film 120 may be conformable and elastic. For example, the covering film 120 may be conformable to non-planar anatomical surfaces, such as the skin of a patient. In some examples, the covering film 120 may have an ultimate elongation greater than 200%. In some examples, the covering film 120 may have an ultimate elongation greater than 400%. Exemplary materials for the covering film 120 can be found in, for example, U.S. Patent Nos. 5,088,483 and 5,160,315, which are incorporated herein by reference. In some examples, the covering film 120 may include an elastomeric polyurethane, a copolyester, or a polyether block amide film. Therefore, the covering film 120 may have the properties of desired conformability, high moisture permeability, and transparency.
[0068] The cover film 120 includes a thickness 120T defined between the first major surface 122 and the second major surface 124. The thickness 120T of the cover film 120 can be defined perpendicular to the dressing plane 116 (i.e., along the z-axis). In some embodiments, the thickness 120T of the cover film 120 can be 12 microns to 130 microns (i.e., about 0.5 mils to about 5 mils). In some embodiments, the thickness 120T of the cover film 120 can be 25 microns to 100 microns.
[0069] In some embodiments, each of the backing 110 and the cover film 120 is continuous in the dressing plane 116 and lacks any through openings. In other words, each of the backing 110 and the cover film 120 may lack any large openings (e.g., openings having a maximum width greater than 1 mm). In some embodiments, each of the backing 110 and the cover film 120 may include micro-openings that may impart breathability and lack large openings. Each of the backing 110 and the cover film 120 may therefore lack macroscopic elements, such as windows or screens extending therethrough.
[0070] The cover dressing 100 also includes a first adhesive layer 130 at least partially disposed 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 plane 116. The first adhesive portion 136 of the first adhesive layer 130 is configured to at least partially adhere to the patient's skin (e.g., Figure 1 The skin 20 of the patient 22 is bonded.
[0071] exist Figure 2A In the illustrated embodiment, the first adhesive layer 130 is partially disposed between the first major surface 112 of the backing 110 and the second major surface 124 of the cover film 120, such that the first adhesive portion 136 is at least partially coextensive with the first film portion 126 in the dressing plane 116. Figure 2A In the illustrated embodiment, the first adhesive layer 130 is coextensive with the second major surface 124 of the cover film 120 in the dressing plane 116 .
[0072] The first adhesive layer 130 may include an adhesive material suitable for application on the skin. The first adhesive layer 130 may include an optically clear adhesive (OCA). The first adhesive layer 130 may include, for example, a pressure-sensitive adhesive (PSA). The pressure-sensitive adhesive may have a relatively high moisture vapor transmission rate to allow moisture to evaporate. Suitable pressure-sensitive adhesives include those based on acrylates, polyurethanes, hydrogels, hydrocolloids, block copolymers, silicones, rubber-based adhesives (including natural rubber, polyisoprene, polyisobutylene, butyl rubber, etc.) and combinations of these adhesives. The adhesive component may contain a tackifier, a plasticizer, a rheology modifier, and an active component. The pressure-sensitive adhesive may be reasonably skin-compatible and "hypoallergenic", such as the acrylate copolymer described in U.S. Patent No. RE 24,906. Particularly useful are 97:3 isooctyl acrylate: acrylamide copolymers, such as 70:15:15 isooctyl acrylate: ethylene oxide acrylate: acrylic acid terpolymers described in U.S. Patent No. 4,737,410. Other useful adhesives are described in U.S. Pat. Nos. 3,389,827; 4,112,213; 4,310,509; and 4,323,557. In some embodiments, first adhesive layer 130 includes an antimicrobial agent. It is contemplated to include a drug or antimicrobial agent in first adhesive layer 130 as described in U.S. Pat. Nos. 4,310,509 and 4,323,557.
[0073] exist Figure 2A In the illustrated embodiment, the first adhesive layer 130 is coextensive with the second major surface 124 of the cover film 120. Alternatively, the first adhesive layer 130 may be partially non-coextensive with the second major surface 124 of the cover film 120, wherein at least a portion of the first adhesive layer 130 is 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 properties. The patterned first adhesive layer 130 may advantageously improve the vapor transmission rate of the cover dressing 100.
[0074] The first adhesive layer 130 includes a thickness 130T. The thickness 130T of the first adhesive layer 130 can be defined perpendicular to the dressing plane 116 (i.e., along the z-axis). In some embodiments, the thickness 130T of the first adhesive layer 130 can be 2.5 microns to 130 microns (i.e., about 0.1 mil to about 5 mils). In some embodiments, the thickness 130T of the first adhesive layer 130 can be 5 microns to 50 microns.
[0075] exist Figure 2AIn the illustrated embodiment, the cover dressing 100 also includes a second adhesive layer 140 at least partially disposed on the second major surface 114 of the backing 110. The second adhesive layer 140 can be configured to at least partially adhere to a medical device (e.g., Figure 1 Specifically, the second adhesive layer 140 can be configured to at least partially adhere to a tube or cannula of a medical device (e.g., Figure 1 The cannula 16 of the medical device 10 is bonded.
[0076] The second adhesive layer 140 may include a repositionable adhesive. Preferably, the second adhesive is easily removable from the medical device so that the cover dressing 100 can be removed from the patient's skin without having to remove the medical device from the insertion site. In addition, the second adhesive layer 140 may have a low cohesive strength at room temperature (e.g., at 27 degrees Celsius).
[0077] In some examples, the second adhesive layer 140 may include a pressure-sensitive adhesive. In some embodiments, the second adhesive layer 140 includes silicone. Suitable silicone adhesives are disclosed in PCT publications WO2010 / 056541 and WO2010 / 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 of a different composition from the adhesive of the first adhesive layer 130.
[0078] exist Figure 2A In the illustrated embodiment, the second adhesive layer 140 is coextensive with the second major surface 114 of the backing 110. Alternatively, the second adhesive layer 140 may be partially non-coextensive with the second major surface 114 of the backing 110. Based on the desired application properties, the second adhesive layer 140 may be substantially continuous or patterned. In some cases, the second adhesive layer 140 may be discontinuous along a portion of the second major surface 114 of the backing 110.
[0079] Second adhesive layer 140 includes thickness 140T. Thickness 140T of second adhesive layer 140 can be defined perpendicular to dressing plane 116 (i.e., along the z-axis). In some embodiments, thickness 140T of second adhesive layer 140 can be between 2.5 microns and 130 microns (i.e., between about 0.1 mils and about 5 mils). In some embodiments, thickness 140T of second adhesive layer 140 can be between 5 microns and 50 microns.
[0080] exist Figure 2AIn the illustrated embodiment, the cover dressing 100 further includes a protrusion 150. The protrusion 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 protrusion 150. The protrusion 150 may also include a protrusion perimeter 155 surrounding the first major surface 152 and the second major surface 154 of the protrusion 150.
[0081] The projection 150 also includes a thickness 150T. The thickness 150T of the projection 150 can be defined between the first major surface 152 and the second major surface 154 of the projection 150. The thickness 150T of the projection 150 can be defined perpendicular to the dressing plane 116 (i.e., along the z-axis). In some embodiments, the thickness 150T of the projection 150 can be 12 microns to 130 microns (i.e., about 0.5 mils to about 5 mils).
[0082] The tab 150 may provide a gripping area that is free of any adhesive, such as the adhesive of the first adhesive layer 130 and the second adhesive layer 140. Specifically, the second major surface 154 of the tab 150 may be free of any adhesive. The tab 150 may be gripped by a user to apply the cover dressing 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 100 to the patient's skin. However, it may be noted that the tab 150 is optional. For example, if 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 100. This configuration will be discussed in more detail later.
[0083] exist Figure 2A In the illustrated embodiment, 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 protrusion 150. Figure 2A In the illustrated embodiment, each of the backing 110 and the second adhesive layer 140 extends beyond the projection perimeter 155 such that the backing perimeter 115 is at least partially spaced apart from the projection perimeter 155 in the dressing plane 116 .
[0084] 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 size of the cover film 120 can be larger than the backing 110. In some embodiments, the area of the second major surface 154 of the protrusion is at most 30% of the area of the second major surface 114 of the backing 110. Thus, the size of the backing 110 can be larger than the protrusion 150. The cover film 120, the backing 110, and the protrusion 150 can have sequentially decreasing sizes in the dressing plane 116.
[0085] exist Figure 2A In the illustrated embodiment, the projection perimeter 155 is partially aligned with the backing perimeter 115 in the dressing plane 116. Figure 2A In the illustrated embodiment, the backing perimeter 115 is partially aligned with the membrane perimeter 125 in the dressing plane 116. In other words, Figure 2A In the illustrated embodiment, the film perimeter 125, the backing perimeter 115, and the projection perimeter 155 are partially aligned with each other and partially misaligned with each other. For example, the film perimeter 125, the backing perimeter 115, and the projection perimeter 155 may be aligned at one end of the cover dressing 100 and misaligned at the opposite end of the cover dressing 100.
[0086] In some embodiments, cover dressing 100 further includes a release liner 160 at least partially and removably adhered to each of first adhesive layer 130 and second adhesive layer 140. For illustrative purposes, release liner 160 is Figure 2B Not shown in FIG.
[0087] Before applying the cover dressing 100 to the patient's skin, the release liner 160 can protect the first adhesive layer 130 and the second adhesive layer 140 from undesirable contaminants, such as dust, debris, etc. 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 cover dressing 100 can include separate release liners for the first adhesive layer 130 and the second adhesive layer 140. This configuration of the release liner will be discussed in more detail later.
[0088] Figure 2C A schematic top view of a covering dressing 100 according to one embodiment of the present disclosure is shown. For illustrative purposes, Figure 2A The first adhesive layer 130, the second adhesive layer 140 and the release liner 160 shown in FIG. Figure 2CIn addition, for illustrative purposes, the backing 110 and the protrusion 150 are shown in FIG. Figure 2C It is schematically shown by a dotted line.
[0089] The covering dressing 100 may have any suitable shape, such as circular, oval, rectangular, oblong, polygonal, etc. Figure 2C In the illustrated embodiment, the cover dressing 100 has a substantially rectangular shape including a pair of transverse edges and a pair of longitudinal edges.
[0090] exist Figure 2C In the illustrated embodiment, the cover film 120 has a generally rectangular shape and includes a first transverse edge 121, a second transverse edge 123 opposite the first transverse edge 121, a first longitudinal edge 128, and a second longitudinal edge 129 opposite the first longitudinal edge 128. The first transverse edge 121 and the second transverse edge 123 may extend along the y-axis. The first longitudinal edge 128 and the second longitudinal edge 129 may extend along the x-axis.
[0091] The first transverse edge 121, the second transverse edge 123, the first longitudinal edge 128, and the second longitudinal edge 129 may collectively define a film perimeter 125 (at Figure 2A and Figure 2B ). The cover film 120 can define a film length 120L that extends along the first longitudinal edge 128 and the second longitudinal edge 129 and between the first transverse edge 121 and the second transverse edge 123 of the cover film 120.
[0092] exist Figure 2C In the illustrated embodiment, the backing 110 has a substantially rectangular shape and includes a first transverse edge 111, a second transverse edge 113 opposite the first transverse edge 111, a first longitudinal edge 118, and a second longitudinal edge 119 opposite the first longitudinal edge 118. The first transverse edge 111 and the second transverse edge 113 may extend along the y-axis. The first longitudinal edge 118 and the second longitudinal edge 119 may extend along the x-axis. The first transverse edge 111, the second transverse edge 113, the first longitudinal edge 118, and the second longitudinal edge 119 may collectively define a backing perimeter 115 (at Figure 2A and Figure 2B ).
[0093] exist Figure 2C In the illustrated embodiment, the second lateral edge 113 of the backing 110 is spaced apart from the second lateral edge 123 of the cover film 120. Figure 2C1, for illustrative purposes only, the first transverse edge 111, the first longitudinal edge 118, and the second longitudinal edge 119 of the backing 110 are shown as being slightly misaligned with the first transverse edge 121, the first longitudinal edge 128, and the second longitudinal edge 129 of the cover film 120, respectively, so that the corresponding first transverse edges can be distinguished from each other. It can be noted that the first transverse edge 111 of the backing 110 may or may not be aligned with the first transverse 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.
[0094] The backing 110 may define a backing length 110L extending along the first longitudinal edge 118 and the second longitudinal edge 119 and extending between the first transverse edge 111 and the second transverse 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 less than the film length 120L by a first length difference 105L. In other words, the first length difference 105L may be a length difference between the film length 120L and the backing length 110L. The first length difference 105L may be, for example, greater than or equal to 50% of the film length 120L.
[0095] exist Figure 2C In the illustrated embodiment, the protrusion 150 has a substantially rectangular shape and includes a first transverse edge 151, a second transverse edge 153 opposite the first transverse edge 151, a first longitudinal edge 158, and a second longitudinal edge 159 opposite the first longitudinal edge 158. The first transverse edge 151 and the second transverse 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 transverse edge 151, the second transverse edge 153, the first longitudinal edge 158, and the second longitudinal edge 159 can collectively define a protrusion perimeter 155 (at Figure 2A and Figure 2B ).
[0096] exist Figure 2C In the illustrated embodiment, the second transverse edge 153 of the protrusion 150 is spaced apart from the second transverse edge 113 of the backing 110. Figure 2C, for illustrative purposes only, the first transverse edge 151, the first longitudinal edge 158, and the second longitudinal edge 159 of the tab 150 are shown as being slightly misaligned with the first transverse edge 121, the first longitudinal edge 128, and the second longitudinal edge 129 of the cover film 120, respectively, so that the corresponding first transverse edges can be distinguished from each other. It can be noted that the first transverse edge 151 of the tab 150 may or may not be aligned with the first transverse 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. Figure 2A and Figure 2B In the illustrated embodiment, the first transverse edge 111 of the backing 110, the first transverse edge 121 of the cover film 120, and the first transverse edge 151 of the protrusion 150 are aligned with each other in the dressing plane 116 (eg, Figure 2C ).
[0097] The tab 150 may define a tab length 150L extending along the first longitudinal edge 158 and the second longitudinal edge 159 and extending 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 less than the backing length 110L by a second length difference 106L. In other words, the second length difference 106L may be a length difference between the backing length 110L and the tab length 150L. The second length difference 106L may, for example, be greater than or equal to 50% of the backing length 110L.
[0098] exist Figure 2B In the illustrated embodiment, the first adhesive layer 130 includes a first lateral edge 131 and a second lateral edge 133 opposite the first lateral edge 131. Figure 2B In the illustrated embodiment, the second adhesive layer 140 includes a first lateral edge 141 and a second lateral edge 143 opposite the first lateral edge 141 .
[0099] See now FIG. 2A to FIG. 2CIn some embodiments, each of the backing 110, the cover film 120, the first adhesive layer 130, the second adhesive layer 140, and the protrusion 150 includes a respective first transverse edge 111, 121, 131, 141, 151 and a respective second transverse edge 113, 123, 133, 143, 153 opposite the respective first transverse edge 111, 121, 131, 141, 151. Furthermore, in some embodiments, the respective first transverse 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 protrusion 150 are aligned in the dressing plane 116. In other words, in some embodiments, first lateral edge 111 of backing 110, first lateral edge 121 of cover film 120, first lateral edge 131 of first adhesive layer 130, and first lateral edge 141 of second adhesive layer 140 are aligned with each other in dressing plane 116. In some embodiments, first lateral edge 151 of protrusion 150 may also be aligned with first lateral edge 111 of backing 110, first lateral edge 121 of cover film 120, first lateral edge 131 of first adhesive layer 130, and first lateral edge 141 of second adhesive layer 140 in dressing plane 116.
[0100] Furthermore, in some embodiments, respective second transverse edges 113, 123, 133, 143, 153 of backing 110, cover film 120, first adhesive layer 130, second adhesive layer 140, and tabs 150 are not aligned in dressing plane 116. In other words, in some embodiments, second transverse edge 113 of backing 110, second transverse edge 123 of cover film 120, second transverse edge 133 of first adhesive layer 130, and second transverse edge 143 of second adhesive layer 140 are not aligned with each other in dressing plane 116. In some embodiments, second transverse edge 153 of tabs 150 may also be not aligned in dressing plane 116 with second transverse edge 113 of backing 110, second transverse edge 123 of cover film 120, second transverse edge 133 of first adhesive layer 130, and second transverse edge 144 of second adhesive layer 140.
[0101] Figure 3 A schematic bottom view of a cover dressing 170 according to another embodiment of the present disclosure is shown. The cover dressing 170 is substantially similar to Figure 2A The cover dressing 100 of FIG. 1 is shown in FIG. 1 , wherein like elements are represented by like reference numerals. For illustrative purposes, the backing 110 and the projection 150 (both in FIG. 1 ) are shown in FIG. Figure 2A ) in Figure 3 However, the covering dressing 170 has Figure 2AThe first adhesive layer and the second adhesive layer of the covering dressing 100 have first adhesive layers 130 and second adhesive layers 140 of different shapes and different configurations.
[0102] Specifically, in Figure 3 In the embodiment shown, the cover dressing 170 has a rectangular shape with rounded edges. In the embodiment shown, the cover film 120 has a rectangular shape with rounded edges. However, it can be noted that the cover film 120, the backing 110 (in Figure 3 ), the first adhesive layer 130, the second adhesive layer 140 and the protrusion 150 (not shown in Figure 3 One or more of the embodiments (not shown) may have a rectangular shape with rounded edges.
[0103] In addition, Figure 3 In the illustrated embodiment, each of the first adhesive layer 130 and the second adhesive layer 140 is disposed on the dressing plane 116 (ie, Figure 3 spaced from the membrane periphery 125 in the xy plane).
[0104] Figure 4 FIG. 2 is a schematic cross-sectional view of a cover dressing 200 according to another embodiment of the present disclosure. The cover dressing 200 is similar to Figure 2A The present invention relates to a covering dressing 100, wherein like elements are indicated by like reference numerals. Figure 2A As compared to the cover dressing 100 of FIG. 1 , the cover dressing 200 includes a second adhesive layer 140 of a different configuration. As a result, the protrusion 150 of the cover dressing 100 is omitted in the cover dressing 200 .
[0105] exist Figure 4 In the illustrated embodiment, the second major surface 114 of the backing 110 includes an adhesive-free region 117 that extends beyond the second adhesive layer 140. Figure 4 In the illustrated embodiment, first lateral edge 141 of second adhesive layer 140 is spaced apart from first lateral edge 111 of backing 110 such that adhesive-free region 117 is defined by second major surface 114 of backing 110 .
[0106] The adhesive-free region 117 can be grasped by a user to apply the cover dressing 200 to the patient's skin. Figure 2A Thus, adhesive-free region 117 may allow tab 150 to be omitted from cover dressing 200 (in Figure 2A ).
[0107] exist Figure 4In the illustrated embodiment, the cover dressing 200 also includes a first release liner 161 at least partially and removably adhered to the first adhesive layer 130. Removal of the first release liner 161 can expose at least a portion of the first adhesive layer 130. Figure 4 In the illustrated embodiment, cover dressing 200 further includes a second release liner 162 at least partially and removably adhered to second adhesive layer 140. Removal of second release liner 162 may expose at least a portion of second adhesive layer 140. Thus, respective portions of first adhesive layer 130 and second adhesive layer 140 may be selectively exposed by removing first release liner 161 and second release liner 162.
[0108] Figure 5A FIG. 2 shows a schematic cross-sectional view of a cover dressing 250 according to another embodiment of the present disclosure. The cover dressing 250 is similar to Figure 2A The cover dressing 100 is similar to the cover dressing 100, wherein like elements are indicated by like reference numerals. However, the cover dressing 250 has a similar Figure 2A The first adhesive layer 130 of the cover dressing 100 is differently configured. In addition, the cover dressing 250 omits Figure 2A The second adhesive layer 140 of the cover dressing 100. In addition, the first adhesive layer 130 is disposed on the cover film 120, so that the cover film 120 is disposed between the backing 110 and the first adhesive layer 130 along the thickness of the cover dressing 250 (ie, the z-axis).
[0109] exist Figure 5A In the illustrated embodiment, the cover dressing 250 includes an adhesive 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 adhesive layer 210 attaches the cover film 120 to the backing 110. It may be noted that the adhesive layer 210 is optional and may be omitted from the cover dressing 250, for example, if the cover film 120 is attached to the backing 110 by mechanical means, such as by sewing.
[0110] exist Figure 5A In the illustrated embodiment, the first adhesive layer 130 is at least partially disposed on the first major surface 122 of the cover film 120. Figure 5A In the illustrated embodiment, the first adhesive layer 130 is disposed on the first major surface 122 of the cover film 120 opposite the backing 110. Thus, the backing 110 is free of the first adhesive layer 130.
[0111] As discussed above, the first adhesive layer 130 defines a first adhesive portion 136 that extends beyond the backing perimeter 115 in the dressing plane 116. The first adhesive portion 136 of the first adhesive layer 130 is configured to at least partially adhere to the patient's skin (e.g., Figure 1 The skin 20 of the patient 22 is bonded. Figure 5A In the illustrated embodiment, the first adhesive layer 130 further defines a second adhesive portion 137 that is at least partially coextensive with the backing 110 in the dressing plane 116. In some embodiments, the second adhesive portion 137 is configured to at least partially bond to the medical device 10 (in Figure 1 ).
[0112] exist Figure 5A In the illustrated embodiment, the covering dressing 250 also includes a protrusion 220. Figure 5A In the illustrated embodiment, the protrusion 220 is disposed on the first adhesive layer 130 such that the protrusion 220 is spaced apart from the first adhesive portion 136 in the dressing plane 116. Figure 5A In the illustrated embodiment, the protrusion 220 is disposed on the second adhesive portion 137 of the first adhesive layer 136 and is spaced apart from the first adhesive portion 130 in the dressing plane 116 .
[0113] The protrusion 220 may include a first major surface 222 and a second major surface 224 opposite to the first major surface 222 of the protrusion 220. Figure 5A In the illustrated embodiment, the first major surface 222 of the projection 220 faces the first major surface 112 of the cover film 120. The projection 220 may also include a projection perimeter 225 surrounding the first major surface 222 and the second major surface 224 of the projection 220. The backing 110 may extend beyond the projection perimeter 225 such that the backing perimeter 115 is at least partially spaced apart from the projection perimeter 225 in the dressing plane 116. In addition, in Figure 5A In the illustrated embodiment, the projection perimeter 225 is partially aligned with the backing perimeter 115 in the dressing plane 116. In some embodiments, the area of the second major surface 224 of the projection 220 is at most 30% of the area of the second major surface 114 of the backing 110.
[0114] The cover dressing 250 may also include a release liner 230. Figure 5A In the embodiment shown, a 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.
[0115] Figure 5BFIG. 2 shows a schematic cross-sectional view of a cover dressing 251 according to another embodiment of the present disclosure. The cover dressing 251 is substantially similar to Figure 5A 250, wherein like elements are denoted by like reference numerals. However, the cover dressing 251 has a first adhesive layer 130 having a different configuration from that of the first adhesive layer of the cover dressing 250.
[0116] Specifically, in Figure 5B In the illustrated embodiment, 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, Figure 5B In the illustrated embodiment, the first major surface 122 of the cover film 120 defines an adhesive-free region 201 that is free of the first adhesive layer 130. The adhesive-free region 201 can enable the tab 220 (in the case of the cover dressing 251) to be omitted. Figure 5A ). Therefore, in Figure 5B In the illustrated embodiment, the covering dressing 251 omits the protrusion 220 .
[0117] Fig. 6A FIG. 2 shows a schematic cross-sectional view of a cover dressing 270 according to another embodiment of the present disclosure. The cover dressing 270 is similar to Figure 5A 1 and 2. The cover dressing 250 of FIG. 1 is a cover dressing 250 of FIG. 1, wherein like elements are represented by like reference numerals. However, the cover dressing 270 has a first adhesive layer 130 that is configured differently from the first adhesive layer of the cover dressing 250. In addition, 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 270.
[0118] exist Fig. 6A In the illustrated embodiment, the first adhesive layer 130 is at least partially disposed on the second major surface 114 of the backing 110. As discussed above, the first adhesive layer 130 defines a first adhesive portion 136 that extends beyond the backing perimeter 115 in the dressing plane 116. Fig. 6A In the illustrated embodiment, the first adhesive layer 130 further defines a second adhesive portion 137 that is at least partially coextensive with the backing 110 .
[0119] exist Fig. 6A In the illustrated embodiment, the covering dressing 270 also includes a protrusion 220. Fig. 6A In the illustrated embodiment, the first major surface 222 of the projections 220 faces the second major surface 114 of the backing 110. The cover dressing 270 may also optionally include a release liner 230.
[0120] Figure 6BFIG. 2 shows a schematic cross-sectional view of a cover dressing 271 according to another embodiment of the present disclosure. The cover dressing 271 is similar to Fig. 6A 270, wherein like elements are denoted by like reference numerals. However, the cover dressing 271 has a first adhesive layer 130 having a different configuration from that of the first adhesive layer of the cover dressing 270.
[0121] Specifically, in Figure 6B In the illustrated embodiment, 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, Figure 6B In the illustrated embodiment, the second major surface 114 of the backing 110 defines an adhesive-free region 203 that is free of the first adhesive layer 130. The adhesive-free region 203 can enable the tab 220 (in the case of the cover dressing 271) to be omitted. Fig. 6A ). Therefore, in Figure 6B In the illustrated embodiment, the covering dressing 271 omits the protrusion 220 .
[0122] Figure 7 A schematic block diagram of a kit 300 for use with a medical device that may be inserted through the skin of a patient at an insertion site is shown in accordance with one embodiment of the present disclosure.
[0123] Kit 300 includes a first cover dressing 101 and a second cover dressing 102. Each of the first cover dressing 101 and the second cover dressing 102 may be equivalent to Figure 2A Covering dressing 100, Figure 3 Covering dressing 170, Figure 4 Covering dressing 200, Figure 5A Covering dressing 250, Figure 5B Covering dressing 251, Fig. 6A Covering dressing 270 or Figure 6B In some embodiments, each of the first cover dressing 101 and the second cover dressing 102 can be identical to each other. In some other embodiments, the first cover dressing 101 and the second cover dressing 102 can be different from each other. For example, in some embodiments, the first cover dressing 101 can be equivalent to Figure 2A The cover dressing 100 and the second cover dressing 102 may be equivalent to Figure 3 Covering dressing 200.
[0124] See also Figures 2A to 4In some embodiments, each of the first cover dressing 101 and the second cover dressing 102 includes a backing 110 including a first major surface 112, a second major surface 114 opposite to the first major surface 112, and a backing perimeter 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 plane 116.
[0125] Furthermore, in some embodiments, each of the first cover dressing 101 and the second cover dressing 102 includes a cover film 120 including a first major surface 122, a second major surface 124 opposite the first major surface 122 and facing the first major surface 112 of the backing 110, and a film perimeter 125 surrounding the first major surface 122 and the second major surface 124 of the cover film 120. The cover film 120 defines a first film portion 126 extending beyond the backing perimeter 115 and a second film portion 127 at least partially coextensive with the backing 110, such that the film perimeter 125 corresponding to the first film portion 126 is at least partially spaced apart from the backing perimeter 115 in the dressing plane 116.
[0126] In addition, in some embodiments, each of the first cover dressing 101 and the second cover dressing 102 includes a first adhesive layer 130 that is partially disposed between the first major surface 112 of the backing 110 and the second major surface 124 of the cover film 120 and includes a first adhesive. The first adhesive layer 130 is also at least partially disposed on the second major 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 (at Figure 1 ).
[0127] In addition, in some embodiments, each of the first cover dressing 101 and the second cover dressing 102 includes a second adhesive layer 140 at least partially disposed on the second major surface 114 of the backing 110. The second adhesive layer 140 is configured to at least partially bond with the medical device 10 (at least partially bonded to the medical device 10). Figure 1 ).
[0128] In some embodiments, the kit 300 may also include gloves, sterile materials or cloth or other absorbent materials. The kit 300 may be provided for use by a clinician in a sterile package. The clinician may easily obtain the first cover dressing 101 and the second cover dressing 102 to apply to the patient's skin.
[0129] Figure 8 The use of an embodiment according to the present disclosure is shown Figure 7 Flow chart of method 400 of kit 300. Method 400 in FIG. 9A to FIG. 9G The reference Figure 8 and FIG. 9A to FIG. 9G Discussion Method 400.
[0130] At step 410, method 400 includes at least partially bonding a first adhesive layer of a first cover dressing to the patient's skin such that at least a portion of a perimeter of a backing of the first cover dressing is disposed adjacent to the insertion site. Fig. 9A As shown in , method 400 may include at least partially bonding the first adhesive layer 130 of the first cover dressing 101 to the skin 20 of the patient 22 such that at least a portion of the backing perimeter 115 of the first cover dressing 101 is disposed adjacent to the insertion site 18. The method 400 may also include at least partially bonding the second adhesive layer 140 of the first cover dressing 101 to the medical device 10.
[0131] At step 420, method 400 further includes rotating the medical device relative to the insertion site so that the first cover dressing is folded and the second major surface of the backing faces away from the skin. Fig. 9A and Fig. 9B As shown, method 400 may include rotating medical device 10 relative to insertion site 18 (e.g., Fig. 9A 109 as shown), so that the first cover dressing 101 is folded and the second major surface 114 of the backing 110 faces away from the skin 20 (in the direction 109 shown in FIG. Fig. 9B ).
[0132] At step 430, method 400 also includes at least partially bonding the first adhesive layer of the second cover dressing to the patient's skin such that at least a portion of the periphery of the backing of the second cover dressing is disposed adjacent to the insertion site and the insertion site is covered by the first cover dressing and the second cover dressing together. Fig. 9C As shown, method 400 may include at least partially bonding the first adhesive layer 130 of the second cover dressing 102 to the skin 20 of the patient 22, so that at least a portion of the backing perimeter 115 of the second cover dressing 102 is disposed adjacent to the insertion site 18, and the insertion site 18 is covered by the first cover dressing 101 and the second cover dressing 102. It can be noted that the insertion site 18 can be surrounded by the cover film 120 of the first cover dressing 101 and the cover film 120 of the second cover dressing 102.
[0133] At step 440, method 400 also includes at least partially bonding the second adhesive layer of the first cover dressing and the second adhesive layer of the second cover dressing to the medical device and to each other, such that the medical device is at least partially disposed between and secured to the first cover dressing and the second cover dressing. Fig.9DAs shown, method 400 may include at least partially bonding the second adhesive layer 140 of the first cover dressing 101 and the second adhesive layer 140 of the second cover dressing 102 to the medical device 10 and to each other, so that the medical device 10 is at least partially disposed between and fixed to the first cover dressing 101 and the second cover dressing 102. The first cover dressing 101 and the second cover dressing 102 may be at least partially wrapped around the medical device 10, so that the second adhesive layer 140 of the first cover dressing 101 and the second adhesive layer 140 of the second cover dressing 102 may be bonded to each other.
[0134] In some embodiments, method 400 further includes removing the second adhesive layer of the second cover dressing from the medical device and the second adhesive layer of the first cover dressing. Fig.9E As shown, method 400 may include removing second adhesive layer 140 of second cover dressing 102 from second adhesive layer 140 of medical device 10 and first cover dressing 101. The second adhesive of second adhesive layer 140 may facilitate removal of second adhesive layer 140 of second cover dressing 102 from second adhesive layer 140 of medical device 10 and first cover dressing 101.
[0135] In some embodiments, method 400 further includes removing the first adhesive layer of the second cover dressing from the patient's skin. Fig.9F As shown, method 400 may include removing first adhesive layer 130 of second cover dressing 102 from skin 20 of patient 22 .
[0136] In some embodiments, method 400 further includes removing the second adhesive layer of the second cover dressing from the medical device. Fig.9F As shown, method 400 may include removing second adhesive layer 140 of second cover dressing 102 from medical device 10 .
[0137] In some embodiments, method 400 further includes removing the first adhesive layer of the first cover dressing from the patient's skin. Figure 9G As shown, method 400 may include removing first adhesive layer 130 of first cover dressing 101 from skin 20 of patient 22 .
[0138] Method 400 may enable a clinician to use kit 300 to apply first cover dressing 101 and second cover dressing 102 to skin 20 of patient 22 (in Figure 1). Thus, first cover dressing 101 and second cover dressing 102 may be used to cover insertion site 18 and protect insertion site 18 from dirt, bacteria, and moisture, thereby reducing the risk of infection at insertion site 18. Method 400 may also enable a clinician to remove first cover dressing 101 and second cover dressing 102 from skin 20 of patient 22 using kit 300.
[0139] 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 approximations that may vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.
[0140] Although specific embodiments have been illustrated and described herein, it will be appreciated by those skilled in the art that a variety of alternative and / or equivalent implementations may replace the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptation or variation of the specific embodiments discussed herein. Therefore, the present disclosure is intended to be limited only by the claims and their equivalents.
Claims
1. A covering dressing, comprising: a backing comprising a first major surface, a second major surface opposite the first major surface, and a backing perimeter surrounding the first major surface and the second major surface of the backing, the first major surface of the backing defining a dressing plane; a cover film comprising a first major surface, a second major surface opposite the first major surface and facing the first major surface of the backing, and a film perimeter surrounding the first and second major surfaces of the cover film, wherein the cover film defines a first film portion extending beyond the backing perimeter and a second film portion at least partially coextensive with the backing, such that the film perimeter corresponding to the first film portion is at least partially spaced apart from the backing perimeter in the plane of the dressing; as well as A first adhesive layer is at least partially disposed on at least one of the backing and the cover film, wherein the first adhesive layer defines a first adhesive portion that extends beyond the periphery of the backing in the plane of the dressing, and wherein the first adhesive portion of the first adhesive layer is configured to at least partially bond to the patient's skin. 2 . The cover dressing of claim 1 , wherein the first adhesive layer is at least partially disposed on the first major surface of the cover film.
3. A covering dressing according to claim 1, wherein the first adhesive layer further defines a second adhesive portion that is at least partially coextensive with the backing in the plane of the dressing, and wherein the second adhesive portion is configured to at least partially bond to the medical device.
4. The cover dressing of claim 1, further comprising an adhesive layer at least partially disposed between the first major surface of the backing and the second major surface of the cover film, and wherein the adhesive layer attaches the cover film to the backing.
5. The cover dressing of claim 1, wherein the first adhesive layer is at least partially disposed on the second major surface of the backing.
6. A covering dressing according to claim 1, further comprising a protrusion arranged on the first adhesive layer so that the protrusion is spaced apart from the first adhesive portion in the dressing plane, the protrusion comprising a first major surface, a second major surface opposite to the first major surface of the protrusion, and a protrusion periphery surrounding the first major surface and the second major surface of the protrusion, wherein the backing extends beyond the protrusion periphery so that the backing periphery is at least partially spaced apart from the protrusion periphery in the dressing plane.
7. A cover dressing according to claim 6, wherein the protrusion perimeter is partially aligned with the backing perimeter in the plane of the dressing.
8. The covering dressing of claim 6, wherein the area of the second major surface of the projection is at most 30% of the area of the second major surface of the backing.
9. The cover dressing of claim 1, further comprising a release liner at least partially and removably adhered to the first adhesive layer, and wherein removal of the release liner exposes at least a portion of the first adhesive layer.
10. A covering dressing according to claim 1, wherein the first adhesive layer is partially disposed between the first major surface of the backing and the second major surface of the covering film, so that the first adhesive portion is at least partially coextensive with the first film portion in the plane of the dressing.
11. The cover dressing of claim 1, further comprising a second adhesive layer at least partially disposed on the second major surface of the backing, wherein the second adhesive layer is configured to at least partially bond to a medical device.
12. The cover dressing of claim 11, wherein the first adhesive layer is coextensive with the second major surface of the cover film.
13. The cover dressing of claim 11, wherein the second adhesive layer is coextensive with the second major surface of the backing.
14. The cover dressing of claim 11, wherein the second adhesive layer comprises a silicone adhesive.
15. The covering dressing of claim 11, wherein the second major surface of the backing comprises an adhesive-free region extending beyond the second adhesive layer.
16. The covering dressing of 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 wherein removal of the release liner exposes at least corresponding portions of the first adhesive layer and the second adhesive layer.
17. The covering dressing of claim 11, further comprising: 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; as well as A second release liner is 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.
18. A covering dressing according to claim 11, further comprising a protrusion, the protrusion comprising a first major surface facing the second major surface of the backing, a second major surface opposite to the first major surface of the protrusion, and a protrusion perimeter surrounding the first major surface and the second major surface of the protrusion, wherein each of the backing and the second adhesive layer extends beyond the protrusion perimeter so that the backing perimeter is at least partially spaced apart from the protrusion perimeter in the plane of the dressing, and wherein the second adhesive layer is partially disposed between the second major surface of the backing and the first major surface of the protrusion.
19. A cover dressing according to claim 18, wherein the projection perimeter is partially aligned with the backing perimeter in the plane of the dressing.
20. A covering dressing according to claim 18, wherein each of the backing, the covering film, the first adhesive layer, the second adhesive layer and the protrusion includes a corresponding first lateral edge and a corresponding second lateral edge opposite to the corresponding first lateral edge, and wherein the corresponding first lateral edges of the backing, the covering film, the first adhesive layer, the second adhesive layer and the protrusion are aligned in the dressing plane.
21. The covering dressing of claim 1, wherein the second major surface of the backing comprises an adhesive-free region extending beyond the first adhesive layer.
22. The cover dressing of claim 1, wherein the first major surface of the cover film comprises an adhesive-free region extending beyond the first adhesive layer.
23. The cover dressing of claim 1 wherein the backing perimeter is partially aligned with the membrane perimeter in the plane of the dressing.
24. The cover dressing of claim 1 wherein the first major surface of the backing has an area that is at most 60% of the area of the second major surface of the cover film.
25. The cover dressing of claim 1, wherein the cover film is optically clear.
26. The covering dressing of claim 1, wherein the backing comprises a foam or a nonwoven material.
27. The cover dressing of claim 1, wherein the first adhesive layer comprises an antimicrobial agent.
28. The cover dressing of claim 1 wherein each of the backing and the cover film is continuous in the plane of the dressing and is devoid of any through openings.
29. A kit for use with a medical device insertable through the skin of a patient at an insertion site, the kit comprising a pair of cover dressings according to claim 1.
30. A kit for use with a medical device insertable through the skin of a patient at an insertion site, the kit comprising a first cover dressing and a second cover dressing, each of the first cover dressing and the second cover dressing comprising: a backing comprising a first major surface, a second major surface opposite the first major surface, and a backing perimeter surrounding the first major surface and the second major surface of the backing, the first major surface of the backing defining a dressing plane; a cover film comprising a first major surface, a second major surface opposite the first major surface and facing the first major surface of the backing, and a film perimeter surrounding the first and second major surfaces of the cover film, wherein the cover film defines a first film portion extending beyond the backing perimeter and a second film portion at least partially coextensive with the backing, such that the film perimeter corresponding to the first film portion is at least partially spaced apart from the backing perimeter in the plane of the dressing; a first adhesive layer disposed partially between the first major surface of the backing and the second major surface of the cover film, wherein the first adhesive layer is also at least partially disposed on the second major surface of the cover film corresponding to the first film portion, and wherein the first adhesive layer is configured to at least partially bond to the patient's skin; as well as A second adhesive layer is at least partially disposed on the second major surface of the backing, wherein the second adhesive layer is configured to at least partially bond to the medical device.
31. A method of using the kit according to claim 30, the method comprising: at least partially bonding the first adhesive layer of the first cover dressing to the patient's skin such that at least a portion of the periphery of the backing of the first cover dressing is disposed adjacent to the insertion site; rotating the medical device relative to the insertion site such that the first cover dressing is folded and the second major surface of the backing faces away from the skin; at least partially bonding the first adhesive layer of the second cover dressing to the patient's skin such that at least a portion of a periphery of the backing of the second cover dressing is disposed adjacent to the insertion site and the insertion site is covered by the first cover dressing and the second cover dressing together; as well as The second adhesive layer of the first cover dressing and the second adhesive layer of the second cover dressing are at least partially bonded to the medical device and to each other such that the medical device is at least partially disposed between and secured to the first cover dressing and the second cover dressing.
32. The method according to claim 31, further comprising: removing the second adhesive layer of the second cover dressing from the medical device and the second adhesive layer of the first cover dressing; removing the first adhesive layer of the second cover dressing from the patient's skin; removing the second adhesive layer of the second cover dressing from the medical device; as well as The first adhesive layer of the first cover dressing is removed from the patient's skin.
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