Occlusive dressing and medical device system

Abstract

An occlusive dressing and medical device system (100) includes a medical device (150) having a hub (160) featuring an occlusive surface (170). The occlusive surface can extend over a plane parallel to a patient's skin surface. A catheter tube (152) can extend through an insertion site in the skin surface and is supported at a proximal end by the hub. An extension leg (158) and / or connector (156) can extend from the occlusive surface. The system also includes a dressing with adhesive to attach to the hub and the skin surface. The dressing can include a fenestration (118) disposed within an outer perimeter of the dressing (116), which receives the extension leg and / or connector therethrough and an edge of the fenestration engages and adheres to the occlusive surface along the entire circumference of the edge. The engagement between the fenestration and the hub can mitigate the formation of pathogen pathways underneath the dressing to reduce the risk of infection.

Description

OCCLUSIVE DRESSING AND MEDICAL DEVICE SYSTEMPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 658,110, filed lune 10, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Previous approaches for applying dressings to percutaneous medical devices include placing a dressing over the insertion site and external portions of the medical device. Exemplary external portions include catheter hubs, extension legs, and connectors, etc. The external portions are laid flat on the skin surface of the patient and the dressing applied over the top and adhered to the surrounding skin surface, with one or more proximal ends, e.g., extension legs, extending beyond an outer perimeter of the dressing to provide fluid communication with the medical device.

[0003] Where the outer perimeter of the dressing extends over the extension leg, gaps can form alongside the extension leg, between the dressing and the skin surface, providing pathways for microbes and other pathogens to enter, leading to infection. Further, these pathways can lead to dressing failure as the incomplete seal at the edge can be caught by clothing, for example, pulling the dressing away from the skin. To try to close these pathways, practitioners will often place a secondary dressing underneath the extension leg and underneath the outer perimeter of primary dressing. The portions of the primary dressing, either side of the extension leg then adhere to a top surface of the secondary dressing. However, pathways can still form between the lower surface of the primary dressing, the top surface of the secondary dressing and the medical device.

[0004] Disclosed herein are occlusive dressing and medical device systems and methods directed to address the foregoing, mitigating infection risk and dressing failure. Furthermore, methods of applying the occlusive dressing are simplified, reducing the number of steps needed to perform dressing changes.SUMMARY

[0005] In some aspects, the techniques described herein relate to a dressing and medical device system including, a medical device including, a catheter tube having a distal end configured to be disposed subcutaneously through an insertion site, a hub coupled to a proximal end of the catheter tube and including an occlusive surface extending over a plane, and one of an extension leg or a connector extending from the occlusive surface, and a dressing having a top surface and a bottom surface, an adhesive layer disposed on a portion of the bottom surface and configured to adhere the dressing to one or both of the hub and a skin surface, the dressing further including a fenestration disposed within an outer perimeter of the dressing, the fenestration configured to engage the occlusive surface along an entire circumference of the fenestration.

[0006] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the hub includes a bottom surface configured to engage the skin surface, a top surface including the occlusive surface and a side wall extending between the top surface and the bottom surface.

[0007] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the side wall extends perpendicular to the skin surface or extends at an angle to define a chamfered edge.

[0008] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the hub defines a hub lumen providing a fluid pathway between the catheter tube and one of the extension leg or the connector.

[0009] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the adhesive layer extends over all the bottom surface of the dressing.

[0010] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the adhesive layer includes an inner adhesive ring extending circumferentially along an edge of the fenestration, and an outer adhesive ring extending circumferentially along an edge of the outer perimeter.

[0011] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein one of the extension leg or the connector extends through the fenestration when an edge of the fenestration engages the occlusive surface.

[0012] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the occlusive surface extends circumferentially about a join between the hub and the extension leg or the connector, the occlusive surface defines a minimum diameter that is greater than an inner diameter of the fenestration.

[0013] In some aspects, the techniques described herein relate to a dressing and medical device system, further including a tear line extending from the fenestration to the outer perimeter of the dressing.

[0014] In some aspects, the techniques described herein relate to a dressing and medical device system, further including one or both of a release liner disposed over the adhesive layer and a window disposed within the outer perimeter and formed of a material that is transparent and forms a sterile barrier.

[0015] In some aspects, the techniques described herein relate to a dressing and medical device system, further including a seam extending from an edge of the fenestration to a point that is within the outer perimeter, the seam including a first portion overlapping a second portion and releasably coupled thereto.

[0016] In some aspects, the techniques described herein relate to a dressing and medical device system, wherein the outer perimeter encircles both the insertion site and the hub when the fenestration is engaged with the occlusive surface.

[0017] In some aspects, the techniques described herein relate to a method of securing a medical device including, placing a distal portion of a catheter tube through an insertion site, a proximal end of the catheter tube supported by a hub having an occlusive surface extending over a plane and one of an extension leg or a connector extending from the occlusive surface, passing one or both of the extension leg and the connector through a fenestration of a dressing, securing an edge of the fenestration to the occlusive surface along an entire circumference of the fenestration, and securing an outer perimeter of the dressing to a skin surface of a patient.

[0018] In some aspects, the techniques described herein relate to a method, wherein the occlusive surface extends over a plane extending parallel to the skin surface.

[0019] In some aspects, the techniques described herein relate to a method, wherein securing the edge of the fenestration to the occlusive surface further includes adhering the edge of the fenestration to the occlusive surface.

[0020] In some aspects, the techniques described herein relate to a method, wherein the occlusive surface extends annularly about one of the extension leg or the connector and has a minimum outer diameter greater than an inner diameter of the fenestration.

[0021] In some aspects, the techniques described herein relate to a method, wherein securing the outer perimeter further includes adhering the outer perimeter to the skin surface of the patient along the entire circumference of the dressing.

[0022] In some aspects, the techniques described herein relate to a method, further including tearing the dressing along a tear line extending between the fenestration and the outer perimeter to remove the dressing from the hub.

[0023] In some aspects, the techniques described herein relate to a method, wherein the outer perimeter encircles both the insertion site and the hub when the edge of the fenestration is secured to the occlusive surface.

[0024] In some aspects, the techniques described herein relate to a method, further including separating a seam prior to passing one of the extension leg or the connector through the fenestration, closing the seam after passing one of the extension leg or the connector through the fenestration by adhering a first portion of the seam to a second portion of the seam, the seam extending from the edge of the fenestration to a point within the outer perimeter of the dressing.BRIEF DESCRIPTION OF DRAWINGS

[0025] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail using the accompanying drawings in which:

[0026] FIG. 1 shows an exploded view of an occlusive dressing and medical device system, in accordance with embodiments disclosed herein.

[0027] FIG. 2 shows a plan view of an occlusive dressing and medical device system, in accordance with embodiments disclosed herein.

[0028] FIG. 3 A shows a side view of an occlusive dressing and medical device system, in accordance with embodiments disclosed herein.

[0029] FIG. 3B shows close up detail of an occlusive dressing and medical device system, in accordance with embodiments disclosed herein.

[0030] FIG. 4A shows top side view of an occlusive dressing, in accordance with embodiments disclosed herein.

[0031] FIG. 4B shows bottom side view of an occlusive dressing, in accordance with embodiments disclosed herein.

[0032] FIG. 5 shows a cross-section view of a medical device for use with the system of FIG. 1, in accordance with embodiments disclosed herein.

[0033] FIG. 6 shows a perspective view of a medical device having a connector extending from a hub, in accordance with embodiments disclosed herein.

[0034] FIG. 7 shows a perspective view of a medical device having a first connector extending from a hub and an extension leg extending from the first connector, in accordance with embodiments disclosed herein.

[0035] FIG. 8 shows a perspective view of a medical device having a three extension legs extending from a hub, in accordance with embodiments disclosed herein.DESCRIPTION

[0036] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodimentsdisclosed herein. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0037] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “right,” “left,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0038] In the following description, the terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and / or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0039] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter or system disclosed herein includes a portion of the catheter or system intended to be near or relatively nearer to a clinician when the catheter or system is used on a patient. Likewise, a “proximal length” of, for example, the catheter or system includes a length of the catheter or system intended to be near or relatively nearer to the clinician when the catheter or system is used on the patient. A “proximal end” of, for example, the catheter or system includes an end of the catheter or system intended to be near or relatively nearer to the clinician when the catheter or system is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter or system can include the proximal end of the catheter or system; however, the proximal portion, the proximal end portion, or the proximal length of the catheter or system need not include the proximal end ofthe catheter or system. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter or system is not necessarily a terminal portion or terminal length of the catheter or system.

[0040] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter or system disclosed herein includes a portion of the catheter or system intended to be near or relatively nearer to a patient when the catheter or system is used on a patient. Likewise, a “distal length” of, for example, the catheter or system includes a length of the catheter or system intended to be near or relatively nearer to the patient when the catheter or system is used on the patient. A “distal end” of, for example, the catheter or system includes an end of the catheter or system intended to be near or relatively nearer to the patient when the catheter or system is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter or system can include the distal end of the catheter or system; however, the distal portion, the distal end portion, or the distal length of the catheter or system need not include the distal end of the catheter or system. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter or system is not necessarily a terminal portion or terminal length of the catheter or system.

[0041] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0042] FIG. 1 shows an exploded view of an occlusive dressing and medical device system (“system”) 100, generally including a dressing 110 and a medical device 150. The dressing 110 extends over a horizontal plane that extends parallel to a skin surface of a patient, and defines a top surface 112, a bottom surface 114, and an outer perimeter 116 extending circumferentially. The dressing 110 can be formed of a material that forms a sterile barrier, for example, the dressing 110 can be formed of one or more materials including plastic, polymer, woven or non-woven materials, gas impermeable materials, combinations thereof, or the like.

[0043] In an embodiment, the dressing 110 further includes a fenestration 118 disposed within the outer perimeter 116 and extending between the top surface 112 and the bottom surface 114. The outer perimeter 116 can define a square, rectangular, rounded rectangular, circular, or an elliptical shape, or any regular or irregular closed curve shape. The fenestration 118 can define a square, rectangular, rounded rectangular, circular, or elliptical shape, or any regular or irregular closed curve shape.

[0044] The bottom surface 114 can include an adhesive layer extending over at least a portion thereof and configured to adhere the dressing 110 to a skin surface of the patient. In an embodiment, the adhesive layer can extend over an entire bottom surface 114 of the dressing 110. In an embodiment, the adhesive layer can extend over a portion of the bottom surface 114, for example, extending along an edge of one or both of the outer perimeter 116 and the fenestration 118. These and other configurations of adhesive layers are contemplated to fall within the scope of the present invention.

[0045] In an embodiment, the medical device 150 generally includes a catheter tube 152 defining a lumen 154 and supported at a proximal end by a hub 160. A distal portion of the catheter tube 152 extends through an insertion site to be disposed subcutaneously within the patient, for example to access a vasculature. In an embodiment, one or both of a proximal end of the catheter tube 152 and the hub 160 remains external to the patient. In an embodiment, one or more of an extension leg 158 and connector 156 extends proximally from the hub 160. In an embodiment, the hub 160 defines a hub lumen 168 extending therethrough and configured to provide fluid communication between the catheter tube 152 and one or both of the extension leg 158 and the connector 156.

[0046] In an embodiment, the hub 160 defines a bottom surface 162, a top surface 164 and a side wall 166 extending therebetween. In an embodiment, the bottom surface 162 extends parallel to a skin surface and is configured to engage the skin surface of the patient. The bottom surface 162 can extend flat, parallel to a horizontal plane, or can include a slight concave or convex shape to facilitate fitting comfortably to the skin surface. In an embodiment, the top surface 164 of the hub 160 extends substantially parallel to one or both of the bottom surface 162 and a horizontal plane. In an embodiment, the side wall 166 extends perpendicular to the horizontal plane between an edge of the bottom surface 162 and an edge of the top surface 164 of the hub 160. In an embodiment, the side wall 166 extends at an angle to the horizontal plane to define a beveled, or chamfered edge, to the hub 160.

[0047] In an embodiment, the top surface 164 of the hub 160 includes an occlusive surface 170. One or both of the extension leg 158 and the connector 156 extends from the occlusive surface 170. In an embodiment, a central axis of the extension leg 158 and / or the connector 156 extends perpendicular to the occlusive surface 170. In an embodiment, a central axis of the extension leg 158 and / or the connector 156 extends at an angle to the occlusive surface 170.

[0048] In an embodiment, one or more of the catheter tubes 152, extension leg 158 and the connector 156 are formed integrally with the hub 160. In an embodiment, one or more of the catheter tube 152, extension leg 158 and the connector 156 are formed separately from the hub 160 and coupled thereto using a press-fit, interference fit, snap-fit engagement, welding, ultrasonic welding, electromagnetic-frequency welding, adhesive, bonding, or similar suitable means. In an embodiment, the connector 156 includes a luer lock, spin nut, twist lock, bayonet lock, or similar suitable fluid connector means. In an embodiment, the medical device 150 can include a peripherally inserted vascular (PIV) catheter, peripherally inserted central catheters, (PICC), midline catheters, central venous catheters (CVC), dialysis catheters, peritoneal catheters, drainage catheters, or similar percutaneous medical device.

[0049] FIG. 2 shows a plan view of the system 100 in place on a skin surface of a patient. FIG. 3 A shows a side view of the system 100 in place on a skin surface of a patient. FIG. 3B shows close up detail of the system 100 of FIG. 3A. As described herein, a distal portion of the catheter tube 152 extends through an insertion site 148 and is disposed subcutaneously. A proximal end of the catheter tube 152 is coupled to the hub 160, a bottom surface 162 of the hub 160 engages a skin surface proximate the insertion site 148. An extension leg 158 extends from a top surface 164 of the hub 160, such as from the occlusive surface 170, and optionally includes a connector 156 coupled to a proximal end thereof.

[0050] A dressing 110 is provided as described herein. A proximal end of the extension leg 158 and / or connector 156 is passed through the fenestration 118 from a bottom surface 114 through to a top surface 112. The fenestration 118 is aligned with the hub 160 at the location where the distal end of the extension leg 158 engages the hub 160. The dressing 110 covers the hub 160, the proximal portion of the catheter tube 152 and the insertion site 148. Worded differently, the outer perimeter 116 of the dressing 110 encircles at least the insertion site 148 and hub 160. As described herein, in an embodiment, the bottom surface 114 of the dressing 110 includes an adhesive layer configured to adhere the dressing 110 to the skin surface of the patient and creating a sterile barrier over the insertion site 148 and the hub 160.

[0051] In an embodiment, the bottom surface 114 of the dressing 110 includes an outer adhesive ring 172, extending along an edge of the outer perimeter 116 and configured to adhere the dressing 110 to the skin surface of the patient, creating a sterile barrier over the insertion site 148 and the hub 160. The bottom surface 114 of the dressing 110 further includes an inneradhesive ring 174, extending along an edge of the fenestration 118 and configured to adhere the dressing 110 to the occlusive surface 170 of the hub 160, creating a seal therebetween.

[0052] In an embodiment, the occlusive surface 170 extends circumferentially about the join between the extension leg 158 / connector 156 assembly and the hub 160. The occlusive surface 170 provides a flat, continuous surface extending circumferentially to which a portion of the dressing 110 extending about the fenestration 118, e.g., the inner adhesive ring 174, can be adhered thereto to provide a complete seal. To note, the dressing 110 surrounding the fenestration 118 extends over a horizontal plane and contacts the occlusive surface, which extends parallel to the dressing 110 to provide continuous contact between the dressing 110 and the hub 160 and creates a seal therebetween. The seal mitigating the formation of gaps, or wrinkles in the dressing 110 that might form pathways that allow ingress of pathogens and the risk of infection.

[0053] In an embodiment, an inner diameter dl) of the fenestration 118 is equal to or greater than an outer diameter of one or both of the extension leg 158 and the connector 156. As such, one or both of the extension leg 158 and the connector 156 can be fed through the fenestration 118. Further, a diameter (t / 2) of the occlusive surface 170 is greater than the inner diameter (t / 7) of the fenestration 118 such that a portion of the dressing 110 extending about the fenestration 118, e.g., adhesive ring 174, contacts the occlusive surface 170 along an entire circumference of the fenestration 118.

[0054] In an embodiment, the dressing 110 further includes a seam 176 extending from the edge of the fenestration 118 radially outwards to a point that is within the outer perimeter 116 of the dressing 110. The seam 176 can include an overlapped portion of the dressing 110 where a first portion of the seam 176 overlaps a second portion of the seam 176 and is releasably secured thereto using adhesive or similar suitable connection. The seam 176 is configured to transition to an open configuration and temporarily extend the fenestration to allow one or both of the extension leg 158 and connector 156 therethrough. For example, the seam 176 can separate therealong to allow the connector 156, defining a relatively larger outer diameter, therethrough, before sealing along the seam to define a smaller diameter fenestration 118 fitting more closely about the relatively smaller diameter of the extension leg 158.

[0055] FIG. 4A shows a top side view of an embodiment of a dressing 110. FIG. 4B shows a bottom side view of the dressing 110. As shown the outer perimeter 116 of the dressing110 can define a substantially rectangular shape and include a fenestration 118 that is disposed off-center from a diametric center point of the dressing 110. In an embodiment, the dressing 110 can include a window 178 extending over at least a portion of the dressing and formed of a transparent material. The window 178 can be configured to maintain a sterile barrier across the dressing while facilitating viewing of the medical device 150 disposed therebelow.

[0056] In an embodiment, the dressing further includes a tear line 180, such as a perforation, score line, laser cut line, groove, or similar line of weakness configured to facilitate separation of the dressing 110 therealong. The tear line 180 can extend between the fenestration 118 and the outer perimeter 116 of the dressing 110. When the dressing 110 is to be removed, the tear line 180 can facilitate separation therealong to facilitate removal of the dressing from the medical device 150 without disturbing the position of the medical device 150.

[0057] As shown in FIG. 4B, the dressing 110 can further include a release liner 182 disposed over the adhesive layer disposed on the bottom surface 114. The release liner 182 can be configured to engage a portion of the adhesive layer. The release liner 182 can be configured to engage a portion of the bottom surface 114. The release liner 182 can be configured to engage the entire bottom surface 114 of the dressing 110. In an embodiment, the outer perimeter of the release liner aligns with the outer perimeter 116 of the dressing 110. The release liner 182 can further include a pull tab extending from an edge of the release liner 182 to facilitate removal of the release liner 182 from dressing 110.

[0058] FIG. 5 shows a cross section view of a medical device 150, generally including a catheter tube 152, a hub 160, an extension leg 158 and a connector 156. The medical device 150 defines a fluid pathway extending through the connector 156, the extension leg 158, the hub 160, and the catheter tube 152. In an embodiment, the catheter tube 152 is formed integrally with the hub 160. In an embodiment, the hub 160 includes a stem 184 extending from a side wall 166 of the hub 160 and configured to engage the catheter tube 152 in a friction fit, interference fit, or press-fit engagement, to provide fluid communication therewith. It will be appreciated that other configurations of stem 184 and fluid coupling are also contemplated to fall within the scope of the present invention.

[0059] As shown in FIG. 5, the occlusive surface 170 extends over a plane that extends substantially parallel to a bottom surface 162 of the hub 160, or parallel with the skin surface.In an embodiment, the occlusive surface can extend over a plane that extends at an angle relative to the bottom surface 162 and / or skin surface. In an embodiment, a central axis of one or both of the extension leg 158 and the connector 156 extends from the occlusive surface at an angle relative to the plane of the occlusive surface 170. In an embodiment, a central axis of one or both of the extension leg 158 and the connector 156 extends perpendicular from the occlusive surface 170.

[0060] FIG. 6 shows an embodiment of a medical device 150 including a connector 156 extending directly from the top occlusive surface 170 of the hub 160. Worded differently, FIG. 6 shows an embodiment of a medical device 150 that does not include an extension leg. In an embodiment, the fenestration 118 encircles the connector 156 extending from the occlusive surface 170.

[0061] FIG. 7 shows an embodiment of a medical device 150 including a first connector extending from an occlusive surface 170 of the hub and an extension leg 158 extending from a side arm of the first connector 156A. The extension leg 158 further including a second connector 156B disposed at a proximal end thereof. In an embodiment, the fenestration 118 encircles the first connector 156A extending from the occlusive surface 170.

[0062] FIG. 8 shows an embodiment of a medical device 150 including two or more extension legs 158 extending from an occlusive surface 170. In an embodiment, the fenestration 118 encircles all the extension legs 158 extending from the occlusive surface 170.

[0063] In an exemplary method of use an occlusive dressing and medical device system 100 is provided as described herein. A distal tip of the catheter tube 152 is placed through an insertion site 148 to a target location and a hub 160 is placed externally on a skin surface adjacent the insertion site 148. One or both of a connector 156 and an extension leg 158 are placed through a fenestration 118 of a dressing 110. Optionally, a seam 176 of the dressing 110 is opened to allow the relatively larger diameter connector 156 through the fenestration 118. The seam 176 can then be closed around the relatively smaller diameter extension leg 158. The fenestration 118 can then be aligned with an occlusive surface 170 of the hub 160. An adhesive layer 174 disposed on a lower surface of the dressing 110 and aligned with the perimeter of the fenestration 118 adheres the fenestration 118 to the occlusive surface 170 creating a seal therebetween.

[0064] The outer perimeter 116 of the dressing encircles the insertion site 148 as well as the hub 160 and proximal portions of the catheter tube 152 such that the dressing 110 covers and creates a sterile barrier thereover. An adhesive layer 172 disposed on a lower surface of the dressing 110 and aligned with the outer perimeter 116 adheres the dressing 110 to the skin surface. Additional adhesive layers are also contemplated, disposed between the inner adhesive layer 174 and the outer adhesive layer 172 to adhere portions of the dressing 110 to the skin surface. In an embodiment, an adhesive layer extends over an entire lower surface of the dressing 110. In an embodiment, at least a portion of the dressing 110 includes a transparent or translucent window 178 to observe one or more of the insertion site 148, catheter tube 152, or hub 160 disposed therebelow. As such, the dressing 110 provides a complete seal at both the inner adhesive layer 174 and the outer adhesive layer 172 to prevent the introduction of pathogens, while still allowing a user to couple the connector 156 to a fluid line, for example, to provide fluid communication with the medical device 150.

[0065] In an embodiment, a user can remove the dressing 110 while leaving the medical device 150 in place. The user can open the seam 176 to widen the fenestration 118 and allow the connector 156 to pass through the fenestration 118. In an embodiment, a user can separate the dressing 110 along a tear line 180 extending between the fenestration 118 and the outer perimeter 116 to facilitate removal of the dressing 110 from the medical device 150 without removing the medical device 150 or disturbing the location of the distal tip of the catheter tube 152 at the target location.

[0066] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A dressing and medical device system, comprising: a medical device comprising: a catheter tube having a distal end configured to be disposed subcutaneously through an insertion site; a hub coupled to a proximal end of the catheter tube and including an occlusive surface extending over a plane; and one of an extension leg or a connector extending from the occlusive surface; and a dressing having a top surface and a bottom surface, an adhesive layer disposed on a portion of the bottom surface and configured to adhere the dressing to one or both of the hub and a skin surface, the dressing further including a fenestration disposed within an outer perimeter of the dressing, the fenestration configured to engage the occlusive surface along an entire circumference of the fenestration.

2. The dressing and medical device system according to claim 1, wherein the hub includes a bottom surface configured to engage the skin surface, a top surface including the occlusive surface and a side wall extending between the top surface and the bottom surface.

3. The dressing and medical device system according to claim 2, wherein the side wall extends perpendicular to the skin surface or extends at an angle to define a chamfered edge.

4. The dressing and medical device system according to any of the preceding claims, wherein the hub defines a hub lumen providing a fluid pathway between the catheter tube and one of the extension leg or the connector.

5. The dressing and medical device system according to any of the preceding claims, wherein the adhesive layer extends over all of the bottom surface of the dressing.

6. The dressing and medical device system according to any of the preceding claims, wherein the adhesive layer includes an inner adhesive ring extending circumferentiallyalong an edge of the fenestration, and an outer adhesive ring extending circumferentially along an edge of the outer perimeter.

7. The dressing and medical device system according to any of the preceding claims, wherein one of the extension leg or the connector extends through the fenestration when an edge of the fenestration engages the occlusive surface.

8. The dressing and medical device system according to any of the preceding claims, wherein the occlusive surface extends circumferentially about a join between the hub and the extension leg or the connector, the occlusive surface defines a minimum diameter that is greater than an inner diameter of the fenestration.

9. The dressing and medical device system according to any of the preceding claims, further including a tear line extending from the fenestration to the outer perimeter of the dressing.

10. The dressing and medical device system according to any of the preceding claims, further including one or both of a release liner disposed over the adhesive layer and a window disposed within the outer perimeter and formed of a material that is transparent and forms a sterile barrier.

11. The dressing and medical device system according to any of the preceding claims, further including a seam extending from an edge of the fenestration to a point that is within the outer perimeter, the seam including a first portion overlapping a second portion and releasably coupled thereto.

12. The dressing and medical device system according to any of the preceding claims, wherein the outer perimeter encircles both the insertion site and the hub when the fenestration is engaged with the occlusive surface.

13. A method of securing a medical device, comprising: placing a distal portion of a catheter tube through an insertion site, a proximal end of the catheter tube supported by a hub having an occlusive surface extending over a plane and one of an extension leg or a connector extending from the occlusive surface;passing one or both of the extension leg and the connector through a fenestration of a dressing; securing an edge of the fenestration to the occlusive surface along an entire circumference of the fenestration; and securing an outer perimeter of the dressing to a skin surface of a patient.

14. The method according to claim 13, wherein the occlusive surface extends over a plane extending parallel to the skin surface.

15. The method according to either claim 13 or 14, wherein securing the edge of the fenestration to the occlusive surface further includes adhering the edge of the fenestration to the occlusive surface.

16. The method according to any of claims 13-15, wherein the occlusive surface extends annularly about one of the extension leg or the connector and has a minimum outer diameter greater than an inner diameter of the fenestration.

17. The method according to any of claims 13-16, wherein securing the outer perimeter further includes adhering the outer perimeter to the skin surface of the patient along the entire circumference of the dressing.

18. The method according to any of claims 13-17, further including tearing the dressing along a tear line extending between the fenestration and the outer perimeter to remove the dressing from the hub.

19. The method according to any of claims 13-18, wherein the outer perimeter encircles both the insertion site and the hub when the edge of the fenestration is secured to the occlusive surface.

20. The method according to any of claims 13-19, further including separating a seam prior to passing one of the extension leg or the connector through the fenestration, closing the seam after passing one of the extension leg or the connector through the fenestration by adhering a first portion of the seam to a second portion of the seam, the seam extending from the edge of the fenestration to a point within the outer perimeter of the dressing.

Images