Dressing base fixation assembly for catheter site

Abstract

The dressing assembly comprises a dressing and a protective member. The dressing comprises a primary fixation portion, a secondary fixation portion, and a peelable layer below the primary and secondary fixation portions. An adhesive is present between the peelable layer and the primary and secondary fixation portions. The end of the primary fixation portion is adjacent to the end of the secondary fixation portion. The protective member has an opening and is attached to the secondary fixation portion. The opening faces the peelable layer and is configured to receive the lumen of a catheter.

Description

[Technical Field]

[0001] Related applications This application claims the priority and benefit of Indian Provisional Patent Application No. 202341061291 filed on September 12, 2023, the entire disclosures of which are incorporated herein by reference in their entirety.

[0002] [Field of the Invention] The present invention is generally directed to medical catheter accessories, and more specifically to a device for assisting in securing a catheter. [Background Art]

[0003] A catheter is a medical device that can be inserted into the body to treat a disease or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmological procedures. For most applications, the catheter is a thin, flexible tube (soft catheter), although catheters of various hardness levels are available depending on the application. A catheter can be inserted into a body cavity, lumen, blood vessel, brain, skin or adipose tissue. Functionally, catheters enable drainage, administration of fluids or gases, access by surgical instruments, and can also perform a wide variety of other tasks depending on the type of catheter.

[0004] When a catheter is to be left in place in a patient for an extended period, fixation techniques are often used to secure the catheter in that position. This is especially true for central venous catheters (CVCs) and peripherally inserted central catheters (PICCs), which are often inserted into the superior vena cava via the patient's neck / chest and upper arm, respectively. Solutions include sutures (shown as 60 in Figure 1) and catheter fixation devices (an exemplary catheter fixation device is the STATLOCK, available from Becton, Dickinson and Co. (Franklin Lakes, New Jersey)). 商標 The device includes, for example, 16 in Figure 3). In any of these techniques, it is typically necessary to change the dressing associated with the insertion site of the catheter. As can be seen in Figures 2A-2C, cleaning around the catheter 50 secured by sutures results in incomplete (and therefore insufficient) cleaning, which may in turn increase the risk of central line-associated bloodstream infection (CLABSI).

[0005] If the catheter is secured with an anchoring device 16, for example, the anchoring device shown in Figure 3, the anchoring device is typically replaced at the same time as the dressing. During the changing of the dressing, the replacement of the anchoring device 16, and the cleaning around the insertion site, the caregiver must avoid excessive movement of the catheter (for example, the catheter tip may move or become dislodged, which could cause the catheter to shift too much and not be properly positioned in the superior vena cava or the intended anatomical site). This is especially important for certain catheters and sites, such as CVCs and PICCs.

[0006] Adhesive-based fixing devices (e.g., STATLOCK) 商標 Various techniques are currently used to temporarily secure a catheter (a fixed catheter) during dressing changes. In one technique, the caregiver may attempt to hold the catheter 50 in place using their fingers (Figure 4A). However, this does not conform to the aseptic non-touch technique (ANTT) and may result in touch contamination. Alternatively, a rolled-up dressing method may be used to temporarily hold the catheter 50 when the fixation device 16 is replaced (Figure 4B). However, the use of rolled-up dressings can lead to inconsistencies (e.g., the amount of dressing to use for rolling). As a third technique, a secondary fixation component, such as adhesive tape 70, may be used to temporarily hold the catheter in place during the removal and replacement of the fixation device (Figure 4C). This requires the caregiver to be aware of doing so and to adhere to a protocol for using adhesive tape during dressing changes. From experience, this protocol has often been found to be ignored due to several constraints. For example, the removal of adhesive tape may be difficult and / or may cause movement of the catheter, and in some cases, the adhesive tape may leave residue on the catheter lumen after removal, thereby attracting contaminants / microorganisms. Due to concerns about catheter movement during dressing changes, adhesive fixation devices may not be replaced sufficiently or at all. [Overview of the project] [Problems that the invention aims to solve]

[0007] It may be desirable to provide techniques to improve dressing changes associated with catheter insertion sites. [Means for solving the problem]

[0008] In a first aspect, embodiments of the present invention are directed to a dressing assembly, the dressing assembly comprising a dressing and a protective member, the dressing comprising a primary securityment portion, a secondary securityment portion, and a peelable layer below the primary and secondary securityment portions, an adhesive being present between the peelable layer and the primary and secondary securityment portions, the end of the primary securityment portion being adjacent to the end of the secondary securityment portion, the protective member having an opening and being attached to the secondary securityment portion, the opening facing the peelable layer and configured to receive the lumen of a catheter.

[0009] In a second aspect, embodiments of the present invention are directed to a dressing assembly comprising a multi-part dressing. The multi-part dressing comprises a primary fixation portion, a secondary fixation portion, and a peelable layer beneath the primary and secondary fixation portions. An adhesive is present between the peelable layer and the primary and secondary fixation portions. The edge of the primary fixation portion is adjacent to the edge of the secondary fixation portion. The primary fixation portion and the secondary fixation layer are configured such that the primary fixation portion can be removed from the secondary fixation portion while the secondary fixation portion remains in place on the patient.

[0010] In a third aspect, embodiments of the present invention are directed toward a kit for protecting a catheter insertion site. The kit comprises an external dressing, a primary fixation device, and an insertion site dressing. The external dressing comprises a primary fixation portion, a secondary fixation portion, and a peelable layer beneath the primary and secondary fixation portions. An adhesive is present between the peelable layer and the primary and secondary fixation portions. The end of the primary fixation portion is adjacent to the end of the secondary fixation portion. The primary fixation device is configured to adhere to the patient's skin and to serve as an attachment point for the catheter hub. The external dressing, the primary fixation device, and the insertion site dressing are housed in a unitary package. [Brief explanation of the drawing]

[0011] [Figure 1] Figure 1 is a top view of a catheter fixed in place with sutures. [Figure 2A] Figures 2A to 2C show attempts to clean around the insertion site of a CVC sutured in place (Figure 2A), the results after cleaning with the CVC still present (Figure 2B), the results after cleaning after the CVC has been removed (Figure 2C), and the skin around areas where cleaning was insufficient. [Figure 2B] Figures 2A to 2C show attempts to clean around the insertion site of a CVC sutured in place (Figure 2A), the results after cleaning with the CVC still present (Figure 2B), the results after cleaning after the CVC has been removed (Figure 2C), and the skin around areas where cleaning was insufficient. [Figure 2C] Figures 2A to 2C show attempts to clean around the insertion site of a CVC sutured in place (Figure 2A), the results after cleaning with the CVC still present (Figure 2B), the results after cleaning after the CVC has been removed (Figure 2C), and the skin around areas where cleaning was insufficient. [Figure 3] Figure 3 is a top view of an exemplary catheter fixation device. [Figure 4A] Figure 4A is a top view showing a caregiver manually holding the catheter near the insertion site with gloved fingers during a dressing change and replacement of the catheter fixation device. [Figure 4B] Figure 4B is a top view showing that a caregiver is temporarily securing the catheter using a rolled-up dressing during the replacement of the catheter fixation device. [Figure 4C] Figure 4C is a top view showing the use of adhesive tape as a secondary fixation component between dressing changes and catheter fixation devices. [Figure 5A] Figure 5A is an exploded perspective view of a dressing base fixing assembly according to an embodiment of the present invention. [Figure 5B] Figure 5B is a partially assembled exploded perspective view of the fixed assembly shown in Figure 5A. [Figure 5C] Figure 5C is a perspective view of a sleeve with a slit. [Figure 6A] Figures 6A to 6H are sequential perspective views illustrating the process of cleaning the catheter insertion site, applying a dressing, and replacing the primary catheter fixation device. [Figure 6B] Figures 6A to 6H are sequential perspective views illustrating the process of cleaning the catheter insertion site, applying a dressing, and replacing the primary catheter fixation device. [Figure 6C] Figures 6A to 6H are sequential perspective views illustrating the process of cleaning the catheter insertion site, applying a dressing, and replacing the primary catheter fixation device. [Figure 6D] Figures 6A to 6H are sequential perspective views illustrating the process of cleaning the catheter insertion site, applying a dressing, and replacing the primary catheter fixation device. [Figure 6E] Figures 6A to 6H are sequential perspective views illustrating the process of cleaning the catheter insertion site, applying a dressing, and replacing the primary catheter fixation device. [Figure 6F] Figs. 6A to 6H are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 6G] Figs. 6A to 6H are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 6H] Figs. 6A to 6H are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 7A] Figs. 7A to 7C are consecutive perspective views showing the process of removing a catheter from a catheter insertion site. [Figure 7B] Figs. 7A to 7C are consecutive perspective views showing the process of removing a catheter from a catheter insertion site. [Figure 7C] Figs. 7A to 7C are consecutive perspective views showing the process of removing a catheter from a catheter insertion site. [Figure 8A] Fig. 8A is an exploded perspective view of a dressing-based securing assembly according to an alternative embodiment of the present invention. [Figure 8B] Fig. 8B is a partially assembled exploded perspective view of the securing assembly of Fig. 8A. [Figure 9A] Figs. 9A to 9H are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9B] Figs. 9A to 9H are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9C] Figs. 9A to 9H are consecutive perspective views showing the process of cleaning a catheter insertion site, and replacing a dressing and the primary catheter securing device. [Figure 9D]Figures 9A to 9H are sequential perspective views illustrating the process of cleaning the catheter insertion site and replacing the dressing and the primary catheter fixation device. [Figure 9E] Figures 9A to 9H are sequential perspective views illustrating the process of cleaning the catheter insertion site and replacing the dressing and the primary catheter fixation device. [Figure 9F] Figures 9A to 9H are sequential perspective views illustrating the process of cleaning the catheter insertion site and replacing the dressing and the primary catheter fixation device. [Figure 9G] Figures 9A to 9H are sequential perspective views illustrating the process of cleaning the catheter insertion site and replacing the dressing and the primary catheter fixation device. [Figure 9H] Figures 9A to 9H are sequential perspective views illustrating the process of cleaning the catheter insertion site and replacing the dressing and the primary catheter fixation device. [Figure 10A] Figures 10A to 10C are sequential perspective views illustrating the process of removing a catheter from the catheter insertion site. [Figure 10B] Figures 10A to 10C are sequential perspective views illustrating the process of removing a catheter from the catheter insertion site. [Figure 10C] Figures 10A to 10C are sequential perspective views illustrating the process of removing a catheter from the catheter insertion site. [Figure 11] Figure 11 is an exploded perspective view of a dressing base fixing assembly according to a further embodiment of the present invention. [Figure 12A] Figure 12A is a perspective view of the fixation assembly shown in Figure 11, positioned at the catheter insertion site. [Figure 12B] Figure 12B is a perspective view of the fixation assembly shown in Figure 11, showing the dressing rolled up to expose the catheter and the primary fixation device. [Modes for carrying out the invention]

[0012] Herein, the present invention is described herein with reference to the accompanying drawings illustrating embodiments of the invention. However, the present invention may be used in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided to ensure that this disclosure is complete and thorough and to fully convey the scope of the invention to those skilled in the art.

[0013] In the drawings, certain layers, components, or features may be exaggerated for clarity, and dashed lines indicate any feature or operation unless otherwise specified.

[0014] In this specification, the terms “first,” “second,” etc., may be used to describe various elements, components, regions, layers, and / or sections, but it will be understood that these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one element, one component, one region, one layer, or one section from another region, another layer, or another section. Accordingly, the first element, first component, first region, first layer, or first section discussed below may be named the second element, second component, second region, second layer, or second section without departing from the teachings of the present invention. The order of operations (or steps) is not limited to the order presented in the claims or drawings unless otherwise specified.

[0015] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as generally understood by one of the ordinary people skilled in the art to which this invention pertains. Furthermore, unless expressly defined herein, terms as defined in commonly used dictionaries should be interpreted as having the meaning consistent with their meanings in the context of this application and related art, and should not be interpreted in an idealized or overly formal sense. Well-known functions or configurations may not be described in detail for the sake of brevity and / or clarity.

[0016] The terms used herein are intended solely to describe specific embodiments and are not intended to limit the invention. Where used herein, the singular forms “one” (a, an) and “the” are intended to also include the plural form unless the context clearly indicates otherwise. Where used herein, the words “equipped with” and / or “equipped with” indicate the presence of the described feature, integer, step, operation, element and / or component, but it will be further understood that they do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof. Where used herein, the words “and / or” include any and all combinations of one or more of the associated enumerated items.

[0017] When used herein, phrases such as "X to Y" and "about X to Y" should be interpreted as including X and Y. When used herein, phrases such as "from about X to Y" mean "from about X to about Y". When used herein, phrases such as "about X to Y" mean "from about X to about Y".

[0018] Referring here to the drawings, the catheter fixation assembly (indicated schematically as 10) is shown in Figures 5A and 5B. The assembly 10 comprises a catheter 11 having a hub 12 and a lumen 14, a primary fixation device 16 (for example, shown in Figure 3 and described in relation thereto), an insertion site dressing 18, and a multi-part dressing 20. The multi-part dressing 20 is described in more detail below.

[0019] The multi-part dressing 20 comprises a secondary fixation portion 22 and a primary fixation portion 24. These portions 22, 24 are connected by peelable strips 26 adjacent to or covering adjacent ends of the portions 22, 24. As shown in Figures 5A and 5B, the secondary fixation portion 22 may have a transparent window 28 that allows observation of the catheter insertion site and the insertion site dressing 18. The primary fixation portion 24 is shown as opaque, but may also have a transparent window that allows observation of the catheter hub 12 and the primary fixation device 16. The transparent window may be semi-transparent or completely transparent to allow observation of the protected device.

[0020] The multi-part dressing 20 also includes a slitted sleeve 30 (best shown in Figure 5C) which is attached to or otherwise integrated with the secondary fixation portion 24. In some embodiments, the slitted sleeve 30 is adhesively bonded to the secondary fixation portion 22. The slitted sleeve 30 is typically rigid or semi-rigid, formed from a polymer material, and has a longitudinal slit 32 (see Figure 5C), which allows the lumen 14 of the catheter hub 12 to be inserted therein.

[0021] The peelable layer (Figure 5A) is located beneath the secondary fixation portion 22, the primary fixation portion 24, and the peelable strip 26. The peelable layer 34 covers an adhesive that allows the multi-part dressing 20 to adhere to the patient's skin. In some embodiments, the adhesive is located entirely beneath the entire secondary fixation portion 22 and the primary fixation portion 24, and also provides an adhesive portion for attaching the slitted sleeve 30 to the secondary fixation portion 22.

[0022] Figures 6A–6C illustrate the application of the multi-part dressing 20 to the catheter insertion site. Figure 6A shows the catheter lumen 14 inserted into a site on the patient's skin, with the accompanying catheter hub 12 positioned nearby. Next, the insertion site dressing 18 is applied to the insertion site (Figure 6B). The insertion site dressing 18 can be any dressing known to be suitable for catheter insertion sites. An exemplary insertion site dressing 18 is GuardIVa, available from Becton Dickinson & Company (Franklin Lakes, New Jersey). 登録商標 This is a dressing. In addition, the primary fixation device 16 is applied (typically by adhesive) to the skin beneath the catheter hub 12, and the catheter hub 12 is mounted on the primary catheter fixation device 16. An example primary catheter fixation device is the StatLock available from Becton Dickinson & Company. 登録商標 It is a device.

[0023] Referring to Figure 6C, the peelable layer 34 beneath the multi-part dressing 20 is removed, and then the multi-part dressing 20 is applied over (a) the insertion site and (b) the catheter hub 12 and the primary fixation device 16 (typically, the multi-part dressing 20 adheres to the patient's skin via the adhesive described above). Importantly, the catheter lumen 14 is inserted through the slit 32 in the slit sleeve 30. Because the slit sleeve 30 is attached to the secondary fixation portion 22, when the multi-part dressing 20 is placed on the patient's skin, the catheter lumen 14 is fixed and should not develop the aforementioned complications that may occur from an unfixed catheter lumen. Therefore, the multi-part dressing 20 secures the catheter lumen 14 while still providing visual access to the insertion site, and further secures the catheter hub 12 and primary fixation device 16 (which is located beneath the primary fixation portion 24 of the multi-part dressing 20). The slitted sleeve 30 also prevents adhesive from the dressing 20 from coming into contact with the lumen 14. Care should be taken to align the slitted sleeve 30 with the catheter lumen 14 while applying the multi-part dressing 20 (in fact, technicians will find it beneficial to attach the slitted sleeve 30 to the catheter lumen 14 as the first step in applying the dressing).

[0024] Figures 6D–6H illustrate the replacement of the insertion site dressing 18 and the cleaning of the insertion site. When it is time to replace the insertion site dressing 18, the strip 26 is first removed by pulling the tab 27 of the peelable strip 26 (Figure 6D). This operation separates portions 22 and 24, thereby allowing the primary fixation portion 24 to be removed while the secondary fixation portion 22 remains in place (Figure 6E). With the primary fixation portion 24 removed, the primary fixation device 16 can be removed, the catheter hub 12 can be lifted, and the area beneath the primary fixation device 16 and the catheter hub 12 can be cleaned. While this is happening, the catheter lumen 14 remains fixed by the secondary fixation portion 22 and the slitted sleeve 30 (see Figure 6E again). Furthermore, the presence of the secondary fixing portion 22 prevents any contamination of the insertion site during cleaning of the area below the primary fixing device 16.

[0025] Once the primary fixation portion / catheter area has been cleaned, a new primary fixation device 16' can be attached to the skin, and the catheter hub 12 can be mounted onto the new primary fixation device 16' (Figure 6F). Again, the catheter lumen 14 remains fixed by the secondary fixation portion 22 and the slitted sleeve 30.

[0026] Once the catheter hub 12 and the new primary fixation device 16' are in place, the secondary fixation portion 22 can be removed, the insertion site dressing 18 can be removed, and the insertion site can be cleaned (Figure 6G). Because the catheter hub 12 is attached to the primary fixation device 16, the catheter lumen 14 is fixed in place. The presence of the slitted sleeve 30 between the catheter lumen 14 and the secondary fixation portion 22 prevents adhesive from the secondary fixation portion 22 from coming into contact with the lumen 14, thereby preventing the lumen 14 from being lifted or otherwise moved during the removal of the secondary fixation portion 22. After the insertion site has been cleaned, a new multi-part dressing 20' and insertion site dressing 18' can be applied to the insertion site in the manner described above in relation to Figures 6A-6C (Figure 6H). Therefore, during the exchange of the dressings 18 and 20, the clean area and the unclean area and / or the device or components do not come into contact with or mix, and thus the area remains uncontaminated.

[0027] If the user wishes to completely remove the catheter from the insertion site instead of replacing the insertion site dressing 18 and the multi-part dressing 20, the multi-part dressing 20 is removed (Figure 7A), the insertion site dressing 18 is removed, the primary fixation device 16 is detached from the catheter hub 12 (Figure 7B), and the catheter hub 12 and catheter lumen 14 are removed from the insertion site (Figure 7C).

[0028] It will be apparent to those skilled in the art that the multi-part dressing 20 allows for the simple replacement of the insertion site dressing 18 and primary fixation device 16, ensures complete cleaning of the area around the insertion site, and eliminates the risk of accidentally displacing the catheter within the insertion site or contaminating either the insertion site or the area beneath the catheter 11.

[0029] Referring to Figures 8A and 8B, another embodiment of the catheter fixation assembly (indicated schematically as 110) is shown. The assembly 110 is similar to assembly 10 in that it includes a catheter 111 having a hub 112 and a catheter lumen 114, a primary fixation device 116, and an insertion site dressing 118. The assembly 110 includes a multi-part dressing 120 which is slightly different from the multi-part dressing 20. The multi-part dressing 120 includes a secondary fixation portion 122 and a primary fixation portion 124, which are similar to the secondary and primary fixation portions of the dressing 20, Rather than the portions 122 and 124 being separated from each other by a peelable strip, in the dressing 120 the portions 122 and 124 are joined by a tear line 126 (e.g., a dotted line or a slotted line), with start notches 128 present at both ends of the tear line 126. Similar to the peelable strip 26 of the dressing 20, the tear line 126 allows the portions 122 and 124 to remain joined to each other for most of the lifespan of the dressing 120, while still being easily separated from each other as needed. A peelable layer 134 (not shown in Figures 8A and 8B, but shown in Figures 9F and 9G) lies beneath the portions 122 and 124, protecting the adhesive applied thereto.

[0030] Referring to Figures 9A to 9C, the dressing 120 is applied to the insertion site in a similar manner to that described above. The catheter lumen 114 is inserted into the insertion site (Figure 9A), the insertion site dressing 118 is applied, and the catheter hub 112 is attached to the patient's skin via the primary fixation device 116 (Figure 9B), and the dressing 120 is applied over the insertion site and catheter 111 (Figure 9C), where the secondary fixation portion 122 covers the insertion site (the catheter lumen 114 is captured by the slitted sleeve 130), and the primary fixation portion 124 covers and secures the catheter hub 112. If the dressings 118, 120 and the primary fixation device 116 are to be replaced (Figure 9D), the primary fixation portion 124 is torn along the tear line 126 to separate it from the secondary fixation portion 122 (Figure 9E), thereby allowing the primary fixation device 116 to be removed and the catheter hub 112 to be lifted for cleaning. As described above with respect to the multi-part dressing 20, the slit sleeve 130 helps to fix the position of the catheter lumen 114 and prevents contact between the catheter lumen 114 and the adhesive under the secondary fixation portion 122. A new primary fixation device 116 is attached to the catheter hub 112 and then to the skin, and a new multi-part dressing 120' is partially applied. The primary fixation portion 124' is attached to the primary fixation device 116 and the catheter hub 112, while the secondary fixation portion 122', on which the release layer 134 still remains, is folded over the primary fixation portion 124' (Figure 9F). Next, the used secondary fixation portion 122 is removed along with the used dressing 118 so that the insertion site can be cleaned (Figure 9G).A new insertion site dressing 118' is added, and then the peelable layer 134 is removed, and the secondary fixation portion 124' of the new dressing 120' is unfolded from the primary fixation portion 122' to cover and protect the insertion site (as previously stated, the catheter lumen 114 is captured in the slit sleeve 130' of the new dressing 120'). As with the multi-part dressing 20, the presence of the peelable layer 134 prevents contamination from the unclean area from reaching the sterile area.

[0031] Figures 10A to 10C show that when the catheter 111 is removed, both portions 122 and 124 of the dressing 120 are removed (Figure 10A) (which includes removing the catheter lumen 114 from the slitted sleeve 130), the dressing 118 and the primary fixation device 116 are removed (Figure 10B), and the insertion site is removed from the catheter 111 (Figure 10C).

[0032] Further alternative assemblies are shown in Figure 11, schematically indicated as 210. The assembly 210 comprises a catheter 211 having a hub 212 and a catheter lumen 214, a primary fixation device 216, and an insertion site dressing 218. The external dressing 220 is not subdivided into removable parts like the multi-part dressings 20, 120, but instead has a continuous secondary fixation portion 222 and a primary fixation portion 224 with a single transparent window 228. A slitted sleeve 230 is fitted into the window 228.

[0033] As shown in Figure 12A, when fitted, the external dressing 220 covers (a) the insertion site and (b) both the catheter hub 212 and the primary fixation device 216, and the slitted sleeve 230 captures the catheter lumen 214 and secures it in place. When the dressing should be replaced, the practitioner rolls up the primary fixation portion 224 of the dressing 220 to expose the catheter hub 212 and the primary fixation device 216 (Figure 12B). The remaining portion of the dressing 220 (i.e., the secondary fixation portion 222) and the slitted sleeve 230 remain in place to secure the catheter lumen 214. The primary fixation device 216 can be removed, the area beneath the primary fixation device 216 can be cleaned, and a new primary fixation device 216 can be attached to the catheter hub 212 and attached to the patient's skin. Next, the remaining portion of the external dressing 220 (i.e., the secondary fixation portion 222) is removed, the insertion site dressing 218 is removed, the insertion site is cleaned, a new insertion site dressing 218 is applied, and then the new dressing 220 is applied over the catheter hub 212 and the insertion site of the new primary insertion device 216.

[0034] Some or all components of assemblies 10, 110, and 210 may be provided as a kit for convenience of storage and use. Typically, such a kit may include one of the dressings 20, 120, and 220 (including their accompanying slitted sleeves), insertion site dressings 18, 118, and 218, and / or primary fixation devices 16, 116, and 216. Such a kit can provide healthcare professionals with a convenient package containing components for the initial application of the primary fixation device and its accompanying dressing, or components for the replacement of the dressing and the primary fixation device. Additional components, such as cleaning or sterilizing solutions, and / or tools for cleaning / sterilization may also be included in the kit. In some implementations, the kit may have a feature to indicate whether it has been opened or tampered with. Examples of such features include color-changing sealants, holographic or image-based indicators, electronic circuits (e.g., RFID antennas), physical seals, or similar devices. The kit may, but may not be, consist of various materials such as paper (including recycled paper), single-layer or multi-layer polymer films (consisting of polypropylene, polyethylene, nylon, polyethylene terephthalate and one or more tie layers), and thin metal films / foils. Because the packaging material comes into direct contact with the medical device, it may be made of biocompatible, non-toxic, and inert materials that do not leach any harmful trace substances during storage, transport, or use.

[0035] In some implementations, the kit (or most of the kit) may include an indicator for identifying any protocol associated with the materials contained within the kit. The indicator may be a machine-readable indicator for identifying the protocol, such as a quick-read code, barcode, or other scannable element. The indicator may be human-recognizable, such as a shape or color. The use of human-recognizable indicators may be beneficial in medical settings where an emergency response is required. In such cases, a distinctive color may be associated with a particular emergency protocol to enable either a machine or a human to more quickly identify the appropriate emergency supplies.

[0036] In addition, in some implementations, the packaging for the kit includes "sequence-specific" packaging, which compels the user to access the components in an order specified by the protocol. For example, a kit for assembly 10 may comprise a primary fixation device 16, an insertion site dressing 18, and a multi-part dressing 20. Such a kit may be configured so that the primary fixation device 16, which is to be used to replace an existing primary fixation device, is accessed first, and then, after being removed from the package, the insertion site dressing 18 and the multi-part dressing 20 can be accessed. This order corresponds to the order shown in Figures 6D–6H. An exemplary sequence-specific packaging is described in PCT application number PCT / US24 / 23807, filed on April 10, 2024, the disclosure of which is incorporated herein in full by reference.

[0037] Those skilled in the art will recognize that embodiments of the present invention can take various forms. For example, any assembly may include protective members of a different configuration rather than the slitted sleeve shown herein. For example, the sleeve may be replaced with a concave shield or the like. Also, as shown herein, the slitted sleeve is secured to the secondary fixation portion using an adhesive that adheres the dressing to the patient's skin, but in other embodiments, the slitted sleeve or other protective member may be attached in a different way (for example, it may be integrated into the window of the dressing or it may have a projection that grips the window). Other possibilities may also be appropriate.

[0038] The foregoing is illustrative of the present invention and should not be construed as limiting the invention. While several exemplary embodiments of the present invention have been described, those skilled in the art will readily understand that many modifications are possible in the exemplary embodiments without substantially departing from the novel teachings and advantages of the present invention. Accordingly, all such modifications are intended to fall within the scope of the present invention.

Claims

1. A dressing assembly, A dressing comprising a primary fixing portion, a secondary fixing portion, and a peelable layer below the primary fixing portion and the secondary fixing portion, wherein an adhesive is present between the peelable layer and the primary fixing portion and the secondary fixing portion, and the end of the primary fixing portion is adjacent to the end of the secondary fixing portion; and, A protective member having an opening, the protective member being attached to the secondary fixing portion, the opening facing the peelable layer, and the opening being configured to receive the lumen of a catheter, the protective member The dressing assembly comprising:

2. The dressing assembly according to claim 1, wherein the protective member is a sleeve, and the opening is a vertical slit in the sleeve.

3. The dressing assembly according to claim 1, wherein the protective member is attached to the secondary fixing portion via the adhesive.

4. The dressing assembly according to claim 1, wherein the primary fixation portion and the secondary fixation layer are configured such that the secondary fixation portion remains on the patient while the primary fixation portion can be removed from the secondary fixation portion.

5. The dressing assembly according to claim 1, wherein the secondary fixing portion is attached to the primary fixing portion by a tear line.

6. The dressing assembly according to claim 1, wherein the secondary fixing portion is attached to the primary fixing portion via a peelable strip.

7. The dressing assembly according to claim 1, wherein the secondary fixing portion is provided with a transparent window.

8. The dressing assembly according to claim 1, wherein the secondary fixing portion and the primary fixing portion are adjacent to each other.

9. A dressing assembly, A multi-part dressing comprising a primary fixing portion, a secondary fixing portion, and a peelable layer below the primary fixing portion and the secondary fixing portion, wherein an adhesive is present between the peelable layer and the primary fixing portion and the secondary fixing portion, and the end of the primary fixing portion is adjacent to the end of the secondary fixing portion. It is equipped with, Here, the primary fixation portion and the secondary fixation layer are configured such that the primary fixation portion can be removed from the secondary fixation portion while the secondary fixation portion remains on the patient. The aforementioned dressing assembly.

10. The dressing assembly according to claim 9, wherein the secondary fixing portion is attached to the primary fixing portion by a tear line.

11. The dressing assembly according to claim 9, wherein the secondary fixing portion is attached to the primary fixing portion via a peelable strip.

12. The dressing assembly according to claim 9, wherein the secondary fixing portion is provided with a transparent window.

13. The dressing assembly according to claim 9, further comprising a protective member having an opening, the protective member being attached to the secondary fixing portion via the adhesive, wherein the opening faces the peelable layer and the opening is configured to receive the lumen of a catheter.

14. The dressing assembly according to claim 13, wherein the protective member is a sleeve, and the opening is a vertical slit in the sleeve.

15. A kit for protecting the catheter insertion site, the kit comprises, An external dressing comprising a primary fixing portion, a secondary fixing portion, and a peelable layer below the primary fixing portion and the secondary fixing portion, wherein an adhesive is present between the peelable layer and the primary fixing portion and the secondary fixing portion, and the end of the primary fixing portion is adjacent to the end of the secondary fixing portion; A primary fixation device configured to adhere to the patient's skin and serve as a mounting position for the catheter hub; and, Insertion site dressing It is equipped with, The external dressing, the primary fixation device, and the insertion site dressing are housed in an integrated package. The aforementioned kit.

16. The kit according to claim 15, wherein the integrated package is a single-use package.

17. The kit according to claim 15, wherein the external dressing is a multi-part dressing.

18. The kit according to claim 15, wherein the external dressing further comprises a protective member having an opening, the protective member being attached to the secondary fixing portion, the opening facing the peelable layer and the opening being configured to receive a catheter lumen.

19. The kit according to claim 18, wherein the protective member is a sleeve with a slit.

20. The kit according to claim 18, wherein the protective member is attached to the secondary fixing portion with the adhesive.

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