Dressing-based securement assembly for catheter site

Abstract

A dressing assembly includes a dressing and a protective member. The dressing includes a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and the secondary securement portion. An adhesive is present between the peelable layer and the primary and secondary securement portions. An edge of the primary securement portion is adjacent an edge of the secondary securement portion. The protective member includes an opening and is attached to the secondary securement portion. The opening faces the peelable layer and is configured to receive a lumen of a catheter.

Description

DRESSING-BASED SECUREMENT ASSEMBLY FOR CATHETER SITERelated Application

[0001] The present application claims priority from and the benefit of Indian Provisional Patent Application No. 202341061291, filed September 12, 2023, the disclosure of which is hereby incorporated herein by reference in full.Field of the Invention

[0002] The present invention is directed generally to medical catheter accessories, and more specifically to devices for aiding in the securing of catheters.Background

[0003] Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic procedures. In most uses, a catheter is a thin, flexible tube (soft catheter) though catheters are available in varying levels of stiffness depending on the application. Catheters can be inserted into a body cavity, duct, or vessel, brain, skin, or adipose tissue. Functionally, they allow drainage, administration of fluids or gases, access by surgical instruments, and perform a wide variety of other tasks depending on the type of catheter.

[0004] When a catheter is left in place in a patient long-term, often a securement technique is employed to secure the catheter in its location. This is particularly 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 at 60 in FIG. 1) and catheter securement devices (an exemplary catheter securement device is the STATLOCK™ device, available from Becton, Dickinson and Co. (Franklin Lakes, New Jersey) - see at 16 in FIG. 3). With either of these techniques,typically a dressing associated with the catheter insertion site requires changing. As can be seen in FIGS. 2A-2C, cleaning around a catheter 50 that is secured by sutures results in incomplete (and therefore inadequate) cleaning, which in turn can increase the risk of central line-associated bloodstream infection (CLABSI).

[0005] When the catheter is secured with a securement device 16 such as that shown in FIG. 3, typically the securement device is changed at the same time as the dressing. During changing of the dressing, replacement of the securement device 16, and cleaning around the insertion site, the caretaker should avoid undue movement of the catheter (for example, tip migration or dislodgement of the catheter may occur, which may result in the catheter shifting sufficiently that it is no longer correctly positioned within the superior vena cava or intended anatomical site. This is particularly important for certain catheters and sites, such as CVCs and PICCs.

[0006] Different techniques are currently used for temporarily securing the catheter during dressing change of adhesive-based securement devices (e.g., STATLOCK™-secured catheters). In one technique, caretakers may attempt to use a finger to hold the catheter 50 in place (FIG. 4A); however, this is not aligned with aseptic non-touch technique (ANTT) and may lead to touch contamination. Alternatively, a rolled-up dressing method may be used to temporarily hold the catheter 50 as the securement device 16 is being replaced (FIG. 4B). However, the use of the rolled-up dressing may present inconsistency (e.g., how much dressing to roll up use). As a third technique, a secondary securement component, such as an adhesive strip 70, may be used to temporarily hold the catheter in position during securement removal and replacement (FIG. 4C). This requires that the caretaker have the awareness to do this and the adherence to protocol to use the adhesive strip during dressing change. Experience has shown that this protocol is often ignored due to a few limitations e.g., removal of the adhesive strip may be difficult and / or may cause movement to the catheter, and in some instances the adhesive strip leaves a residue on the catheter lumen after removal that can attract contaminants / microbes.Sometimes, due to anxiety of catheter movement during dressing change, adhesive securement device may not be changed often enough or at all.

[0007] It may be desirable to provide techniques for improved dressing changes associated with catheter insertion sites.Summary

[0008] As a first aspect, embodiments of the invention are directed to a dressing assembly. The dressing assembly comprises a dressing and a protective member. The dressing comprises a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and the secondary securement portion. An adhesive is present between the peelable layer and the primary and secondary securement portions. An edge of the primary securement portion is adjacent an edge of the secondary securement portion. The protective member includes an opening and is attached to the secondary securement portion. The opening faces the peelable layer and is configured to receive a lumen of a catheter.

[0009] As a second aspect, embodiments of the invention are directed to a dressing assembly comprising a multi-part dressing. The multi-part dressing comprises a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and the secondary securement portion. An adhesive is present between the peelable layer and the primary and secondary securement portions. An edge of the primary securement portion is adjacent an edge of the secondary securement portion. The primary securement portion and the secondary securement layer are configured so that the primary securement portion is removable from the secondary securement portion as the secondary securement portion remains in place on a patient.

[0010] As a third aspect, embodiments of the invention are directed to a kit for protecting a catheter insertion site. The kit includes an exterior dressing, a primary securement device, and an insertion site dressing. The exterior dressing comprises a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and the secondary securement portion. An adhesive is present between the peelable layer and the primary and secondary securement portions. An edge of the primary securement portion is adjacent an edge of the secondary securement portion. The primary securement device configured to adhere to the skin of a patient and to serve as a mounting location for a catheter hub. The exterior dressing, the primary securement device and the insertion site dressing are housed in a unitary package.Brief Description of the Figures

[0011] FIG. 1 is a top view of a catheter secured in place with sutures.

[0012] FIGS. 2A-2C illustrate an attempt to clean around the insertion site of a CVC that is sutured in place (FIG. 2A), with the result shown after cleaning with the CVC still present (FIG. 2B) and after cleaning with the CVC removed (FIG. 2C) to show the skin around the site that was net incompletely cleaned.

[0013] FIG. 3 is a top view of an exemplary catheter securement device.

[0014] FIG. 4A is a top view illustrating a caretaker manually holding a catheter with a gloved finger near the insertion site during dressing change and replacement of the catheter securing device.

[0015] FIG. 4B is a top view illustrating a caretaker using a rolled-up dressing method to temporarily secure a catheter in place during replacement of the catheter securing device.

[0016] FIG. 4C is a top view illustrating the use of an adhesive strip as a secondary securement component during dressing change and replacement of the catheter securing device.

[0017] FIG. 5A is an exploded perspective view of a dressing-based securement assembly according to embodiments of the invention.

[0018] FIG. 5B is a partially assembled exploded perspective view of the securement assembly of FIG. 5 A.

[0019] FIG. 5C is an isometric view of the slitted sleeve.

[0020] FIGS. 6A-6H are sequential perspective views showing the process of cleaning a catheter insertion site and replacing dressings and the primary catheter securement device.

[0021] FIGS. 7A-7C are sequential perspective views showing the process of removing a catheter from a catheter insertion site.

[0022] FIG. 8A is an exploded perspective view of a dressing-based securement assembly according to alternative embodiments of the invention.

[0023] FIG. 8B is a partially assembled exploded perspective view of the securement assembly of FIG. 8 A.

[0024] FIGS. 9A-H are sequential perspective views showing the process of cleaning a catheter insertion site and replacing dressings and the primary catheter securement device.

[0025] FIGS. 10A-10C are sequential perspective views showing the process of removing a catheter from a catheter insertion site.

[0026] FIG. 11 is an exploded perspective view of a dressing-based securement assembly according to further embodiments of the invention.

[0027] FIG. 12A is a perspective view of the securement assembly of FIG. 11 in place at a catheter insertion site.

[0028] FIG. 12B is a perspective view of the securement assembly of FIG. 11 with the dressing rolled to expose the catheter and the primary securement device.Detailed Description

[0029] The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0030] In the figures, certain layers, components or features may be exaggerated for clarity, and broken lines illustrate optional features or operations unless specified otherwise.

[0031] It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0032] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and / or clarity.

[0033] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, thesingular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0034] As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."

[0035] Referring now to the drawings, a catheter securement assembly, designated broadly at 10, is shown in FIGS. 5A and 5B. The assembly 10 includes a catheter 11 with a hub 12 and a lumen 14, a primary securement device 16 (such as that shown in FIG. 3 above and discussed in connection therewith), an insertion site dressing 18, and a multi-part dressing 20. The multi-part dressing 20 is described in more detail below.

[0036] The multi-part dressing 20 includes a secondary securement portion 22 and a primary securement portion 24. These portions 22, 24 are connected via a peelable strip 26 that is adjacent to or that overlies adjacent edges of the portions 22, 24. As shown in FIGS. 5A and 5B, the secondary securement portion 22 may have a transparent window 28 that permits observation of the catheter insertion site and the insertion site dressing 18. The primary securement portion 24 is shown as being opaque, but may also include a transparent window that permits observation of the catheter hub 12 and the primary securement device 16. The transparent window may be semi-transparent or fully transparent to permit observation of the protected devices.

[0037] The multi-part dressing 20 also includes a slitted sleeve 30 (seen best in FIG. 5C) that is attached to or otherwise integrated with the secondary securement portion 24. In some embodiments, the slitted sleeve 30 is adhesively bonded to the secondary securement portion 22. The slitted sleeve 30, which is typically rigid or semi-rigid and formed of a polymeric material, has a longitudinal slit 32 (see FIG. 5C) that allows the lumen 14 of the catheter hub 12 to be inserted therein.

[0038] A peelable layer (FIG. 5A) underlies the secondary and primary securement portions 22, 24 and the peelable strip 26. The peelable layer 34 covers adhesive that enables the multi -part dressing 20 to adhere to the patient’s skin. In some embodiments, the adhesive fully underlies the entirety of the secondary and primary securement portions 22, 24, and also provides the bond that attaches the slitted sleeve 30 to the secondary securement portion 22.

[0039] FIGS. 6A-6C illustrate the application of the multi-part dressing 20 to a catheter insertion site. FIG. 6A shows the catheter lumen 14 inserted into a site on the patient’s skin and the accompanying catheter hub 12 positioned nearby. The insertion site dressing 18 is then applied to the insertion site (FIG. 6B). The insertion site dressing 18 can be any dressing known to be appropriate for catheter insertion sites; an exemplary insertion site dressing 18 is the GuardIVa® dressing, available from Becton Dickinson & Company (Franklin Lakes, New Jersey). In addition, the primary securement device 16 is applied (typically via adhesion) to the skin below the catheter hub 12, and the catheter hub 12 is mounted onto the primary catheter securement device 16. An exemplary primary catheter securement device is the StatLock® device, available from Becton Dickinson & and Company.

[0040] Referring now to FIG. 6C, the underlying peelable layer 34 of the multi-part dressing 20 is removed, and the multi-part dressing 20 is then applied over (a) the insertion site and (b) the catheter hub 12 and the primary securement device 16 (typically the multi-part dressing 20 is adhered to the patient’s skin via the adhesive discussed above). Importantly, the catheter lumen 14 is inserted through the slit 32 in the slitted sleeve 30. Because the slitted sleeve 30 is attached to the secondary securement portion 22, once the multi-part dressing 20 is in place on the patient’s skin, the catheter lumen 14 is secured and should not suffer from of the complications discussed above that can arise from an unsecured catheter lumen. Thus, the multipart dressing 20 secures the catheter lumen 14 while still providing visual access to the insertion site and additional security to the catheter hub 12 and primary securement device 16 (which are beneath the primary securement portion 24 of the multi-part dressing 20). Also, the slitted sleeve 30 prevents adhesive from the dressing 20 from contacting the lumen 14. Care should be taken to align the slitted sleeve 30 with the catheter lumen 14 during application of the multi-part dressing 20 (and in fact the technician may find that fitting the slitted sleeve 30 to the catheter lumen 14 as a first step in applying the dressing is beneficial).

[0041] FIGS. 6D-6H illustrate the changing of the insertion site dressing 18 and the cleaning of the insertion site. When the time arrives for the insertion site dressing 18 to be changed, first the peelable strip 26 is removed by pulling on the tab 27 of the peelable strip 26 (FIG. 6D). This action separates the portions 22, 24, thereby allowing the primary securement portion 24 to be removed while the secondary securement portion 22 remains in place (FIG. 6E). The absence of the primary securement portion 24 allows the primary securement device 16 to be removed, the catheter hub 12 to lifted, and the area beneath the primary securement device 16 and the catheter hub 12 to be cleaned. As this is occurring, the catheter lumen 14 remains secure due to the secondary securement portion 22 and the slitted sleeve 30 (see again FIG. 6E). Moreover, the presence of the secondary securement portion 22 prevents any contamination of the insertion site during cleaning of the area beneath the primary securement device 16.

[0042] Once cleaning of the primary securement / catheter area is complete, a new primary securement device 16’ can be affixed to the skin, and the catheter hub 12 can be mounted on the new primary securement device 16’ (FIG. 6F). Again, the catheter lumen 14 remains securely in place due to the secondary securement portion 22 and the slitted sleeve 30.

[0043] Once the catheter hub 12 and the fresh primary securement device 16’ are positioned, the secondary securement portion 22 can be removed, the insertion site dressing 18 can be removed, and the insertion site can be cleaned (FIG. 6G). The catheter lumen 14 is secured in place because the catheter hub 12 is mounted on the primary securement device 16. The presence of the slitted sleeve 30 between the catheter lumen 14 and the secondary securement portion 22 prevents adhesive from the secondary securement portion 22 from contacting the lumen 14, which in turns prevents the lumen 14 from being lifted or otherwise moved during removal of the secondary securement portion 22. After the insertion site is clean, a new multi-part dressing 20’ and insertion site dressing 18’ can be applied to the insertion site (FIG. 6H) in the manner described above in connection with FIGS. 6A-6C. Thus, during the changing of the dressings 18, 20, there is no contact or mixing of clean and unclean areas and / or devices or components, so the area remains uncontaminated.

[0044] If instead of changing the insertion site dressing 18 and multi-part dressing 20, the user wishes to remove the catheter from the insertion site entirely, the multi-part dressing 20 is removed (FIG. 7A), the insertion site dressing 18 is removed, the primary securement device 16is disassembled from the catheter hub 12 (FIG. 7B), and the catheter hub 12 and catheter lumen 14 are removed from the insertion site (FIG. 7C).

[0045] It should be apparent to those of skill in this art that the multi-part dressing 20 enables the insertion site dressing 18 and primary securement device 16 to be replaced in a straightforward manner, and the area around the insertion site to be fully cleaned, and to do so without the risk of either inadvertently disturbing the catheter in the insertion site or contaminating either the insertion site or the area beneath the catheter 11.

[0046] Referring now to FIGS. 8A and 8B, another embodiment of a catheter securement assembly, designated broadly at 110, is shown therein. The assembly 110 is similar to the assembly 10 in that it includes a catheter 111 with a hub 112 and a catheter lumen 114, a primary securement device 116, and an insertion site dressing 118. The assembly 110 includes a multipart dressing 120 that differs slightly from the multi-part dressing 20. The multi-part dressing 120 includes a secondary securement portion 122 and a primary securement portion 124 that are similar to those of the dressing 20, but instead of the portions 122, 124 being separated from each other by a peelable strip, in the dressing 120 the portions 122, 124 are joined at a tear line 126 (e.g., a dotted or slotted line), with starter notches 128 present at either end of the tear line 126. Like the peelable strip 26 of the dressing 20, the tear line 126 allows the portions 122, 124 to remain joined together for most of the usage period of the dressing 120, but also to be easily separated from each other when needed. A peelable layer 134 (not shown in FIGS. 8A and 8B, but shown in FIG. 9F and 9G)) underlies the portions 122, 124 to protect an adhesive applied thereto.

[0047] Referring now to FIGS. 9A-9C, the dressing 120 is applied to the insertion site in a similar manner to that described above for the dressing 120: the catheter lumen 114 is inserted into the insertion site (FIG. 9A), the insertion site dressing 118 is applied and the catheter hub 112 is mounted to the patient’s skin via the primary securement device 116 (FIG. 9B), and the dressing 120 is applied over the insertion site and catheter 111 (FIG. 9C), with the secondary securement portion 122 overlying the insertion site (with the catheter lumen 114 captured by the slitted sleeve 130) and the primary securement portion 124 overlying and securing the catheter hub 112. When the dressings 118, 120 and primary securement device 116 are to be changed (FIG. 9D), the primary securement portion 124 is tom along the tear line 126 to separate it from the secondary securement portion 122 (FIG. 9E), which allows the primary securement device116 to be removed and the catheter hub 112 lifted for cleaning. As described above with respect to the multi-part dressing 20, the slitted sleeve 130 helps to secure the position of the catheter lumen 114 while preventing contact between the catheter lumen 114 and the adhesive underlying the secondary securement portion 122. A fresh primary securement device 116 is attached to the catheter hub 112 and attached to the skin, and a fresh multi-part dressing 120’ is partially applied; the primary securement portion 124’ is attached over the primary securement device 116 and the catheter hub 112, but the secondary securement portion 122’, with its peelable layer 134 still in place, is folded back over and above the primary securement portion 124’ (FIG. 9F). The used secondary securement portion 122 is then removed along with the used dressing 118 so that the insertion site can be cleaned (FIG. 9G). A fresh insertion she dressing 118’ is add, and the peelable layer 134 is then removed and the secondary securement portion 124’ of the fresh dressing 120’ is unfolded from the primary securement portion 122’ to overlie and protect the insertion site (as discussed above, the catheter lumen 114 is captured in the slitted sleeve 130’ of the fresh dressing 120’). As is the case with the multi-part dressing 20, the presence of the peelable layer 134 can prevent contamination from an unclean area from reaching a sterile area.

[0048] FIGS. 10A-10C illustrate that when the catheter 111 is to be removed, both portions 122, 124 of the dressing 120 are removed (FIG. 10A) (which includes removal of the catheter lumen 114 from the slitted sleeve 130), removal of the dressing 118 and the primary securement device 116 (FIG. 10B), and removal of the catheter 11 from the insertion site (FIG. 10C).

[0049] A further alternative assembly is shown in FIG. 11 and designated broadly at 210. The assembly 210 includes a catheter 211 with a hub 212 and a catheter lumen 214, a primary securement device 216, and an insertion site dressing 218. The exterior dressing 220 is not subdivided into detachable portions like the multi -part dressings 20, 120, but instead has contiguous secondary and primary securement portions 222, 224 with a single transparent window 228. A slitted sleeve 230 is attached within the window 230.

[0050] As shown in FIG. 12A, in position the exterior dressing 220 covers both (a) the insertion site and (b) the catheter hub 212 and primary securement device 216; the slitted sleeve 230 captures the catheter lumen 214 to secure it in place. When the dressings are to be changed, the practitioner rolls up the primary securement portion 224 of the dressing 220 to expose the catheter hub 212 and primary securement device 216 (FIG. 12B). The remainder of the dressing220 (i.e., the secondary securement portion 222) and the slitted sleeve 230 stay in place to secure the catheter lumen 214. The primary securement device 216 can be removed, the area under the primary securement device 216 can be cleaned, and a fresh primary securement device 216 can be attached to the catheter hub 212 and mounted to the patient’s skin. The remainder of the exterior dressing 220 (i.e., the secondary securement portion 222) can then be removed, the insertion site dressing 218 removed, the insertion site cleaned, a fresh insertion site dressing 218 applied, and a fresh dressing 220 applied over the insertion site the catheter hub 212 and fresh primary insertion device 216.

[0051] Some or all of the components of the assemblies 10, 110, 210 may be provided as a kit for convenience of storage and use. Typically, a kit may include one of the dressings 20, 120, 220 (with its accompanying slitted sleeve), an insertion site dressing 18, 118, 218, and / or a primary securement device 16, 116, 216. Such a kit can provide the practitioner with a convenient package that includes components for the initial application of a primary securement device and the accompanying dressings or for the changing of the dressings and the primary securement device. Additional components, such as a cleaning or sterilizing solution and / or a tool for cleaning / sterilizing, may also be included in the kit. In some implementations, the kit may include a feature to indicate whether the kit has been breached or tampered with. Examples of such a feature include: color changing sealant, holographic or other image-based indicators, electronic circuit (e.g., RFID antenna), physical seal, or similar devices. The kit may be formed of a material such as, but not limited to, paper including recycled paper, mono or multi-layer polymeric film comprised of polypropylene, polyethylene, nylon, polyethylene terephthalate, and tie layer(s) or metallic thin film / foil etc. As packaging material is directly coming in contact of medical device, it may be formed of biocompatible, non-toxic, inert material not leaching out any harmful trace materials on storage, transportation, or usage.

[0052] In some implementations, the kit (or substantial portions of the kit) may include an indicator to identify any protocols associated with the materials stored in the kit. The indicator may be a machine-readable indicator such as a quick read code, barcode, or other scannable element to identify the protocol. The indicator may be human perceivable such as a shape or color. Use of a human perceivable indicator may be beneficial in a care setting where urgent action may be needed. In such instances, a distinctive color may be associated with a specificemergency protocol to allow faster identification by either a machine or a human of the appropriate emergency supplies.

[0053] In addition, in some implementations packaging for the kit may include “sequence specific” packing that forces the user to access the components in the sequence in which a protocol prescribes them to be used. As an example, a kit for the assembly 10 may include a primary securement device 16, an insertion site dressing 18, and a multi-part dressing 20. Such a kit may be constructed so that the primary securement device 16, which is to be used to replace the existing primary securement device, must be accessed first and removed from the package before the insertion site dressing 18 and multi-part dressing 20 can be accessed. This sequence matches the sequence described in FIGS. 6D-6H. Exemplary sequence-specific packages are described in PCT Application No. PCT / US24 / 23807, filed April 10, 2024, the disclosure of which is hereby incorporated by reference herein in full.

[0054] Those skilled in this art will recognize that embodiments of the invention may take different forms. For example, rather than a slitted sleeve as shown herein, any of the assemblies may include a protective member of another configuration. As one example, the sleeve may be replaced with a concave shield or the like. Also, although as shown herein the slitted sleeve is fixed to the secondary securement portion with the adhesive that adheres the dressing to the patient’s skin, in other embodiments the slitted sleeve or other protective member may be attached in another fashion (e.g., it may be integrated into the window of the dressing, or may have barbs that grasp the window). Other possibilities may also be suitable.

[0055] The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention.

Claims

That Which is Claimed is:

1. A dressing assembly comprising: a dressing comprising a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and the secondary securement portion, wherein an adhesive is present between the peelable layer and the primary and secondary securement portions, and wherein an edge of the primary securement portion is adjacent an edge of the secondary securement portion; and a protective member including an opening, the protective member attached to the secondary securement portion, wherein the opening faces the peelable layer, the opening configured to receive a lumen of a catheter.

2. The dressing assembly defined in Claim 1, wherein the protective member is a sleeve, and wherein the opening is a longitudinal slit in the sleeve.

3. The dressing assembly defined in Claim 1, wherein the protective member is attached to the secondary securement portion via the adhesive.

4. The dressing assembly defined in Claim 1, wherein the primary securement portion and the secondary securement layer are configured so that the primary securement portion is removable from the secondary securement portion as the secondary securement portion remains in place on a patient.

5. The dressing assembly defined in Claim 1, wherein the secondary securement portion is attached to the primary securement portion at a tear line.

6. The dressing assembly defined in Claim 1, wherein the secondary securement portion is attached to the primary securement portion via a peelable strip.

7. The dressing assembly defined in Claim 1, wherein the secondary securement portion includes a transparent window.

8. The dressing assembly defined in Claim 1, wherein the secondary securement portion and the primary securement portion are contiguous.

9. A dressing assembly comprising: a multi-part dressing comprising a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and the secondary securement portion, wherein an adhesive is present between the peelable layer and the primary and secondary securement portions, and wherein an edge of the primary securement portion is adjacent an edge of the secondary securement portion; wherein the primary securement portion and the secondary securement layer are configured so that the primary securement portion is removable from the secondary securement portion as the secondary securement portion remains in place on a patient.

10. The dressing assembly defined in Claim 9, wherein the secondary securement portion is attached to the primary securement portion at a tear line.

11. The dressing assembly defined in Claim 9, wherein the secondary securement portion is attached to the primary securement portion via a peelable strip.

12. The dressing assembly defined in Claim 9, wherein the secondary securement portion includes a transparent window.

13. The dressing assembly defined in Claim 9, further comprising a protective member including an opening, the protective member adhered via the adhesive to the secondary securement portion, wherein the opening faces the peelable layer, the opening configured to receive a lumen of a catheter.

14. The dressing assembly defined in Claim 13, wherein the protective member is a sleeve, and wherein the opening is a longitudinal slit in the sleeve.

15. A kit for protecting a catheter insertion site, the kit comprising: an exterior dressing comprising a primary securement portion, a secondary securement portion, and a peelable layer underlying the primary securement portion and thesecondary securement portion, wherein an adhesive is present between the peelable layer and the primary and secondary securement portions, and wherein an edge of the primary securement portion is adjacent an edge of the secondary securement portion; a primary securement device configured to adhere to the skin of a patient and to serve as a mounting location for a catheter hub; and an insertion site dressing; wherein the exterior dressing, the primary securement device and the insertion site dressing are housed in a unitary package.

16. The kit defined in Claim 15, wherein the unitary package is a single-use package.

17. The kit defined in Claim 15, wherein the exterior dressing is a multi -part dressing.

18. The kit defined in Claim 15, wherein the exterior dressing further comprises a protective member including an opening, the protective member attached to the secondary securement portion, wherein the opening faces the peelable layer, the opening configured to receive a catheter lumen.

19. The kit defined in Claim 18, wherein the protective member is a slitted sleeve.

20. The kit defined in Claim 18, wherein the protective member is adhered to the secondary securement portion with the adhesive.

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