Multi-layer Dressing Cover for Providing Access to Patient Implants and Wounds

A dressing cover includes a base layer having an adhesive configured to adhere to skin of a patient. The base layer defines a cutout configured to provide access to a cannula insertion site of the skin. The dressing cover further includes a top layer having an adhesive removably adhered to the base layer. The top layer is configured to cover the insertion site and includes an at least partially transparent window overlaying the cutout of the base layer. The window is configured to allow observation of the insertion site.

BACKGROUND OF THE INVENTION

Field of the Invention

The present disclosure relates to dressing covers, and more particularly to dressing covers having multiple layers.

Description of Related Art

Intravenous (IV) therapy is a medical technique used to deliver fluids, medications, and/or nutrition directly into a body of a patient via an IV line (e.g., an IV cannula, an IV catheter, etc.) inserted into a vein. IV therapy may be used for rehydration, to provide nutrition to a person who cannot consume food or water by mouth, and/or to administer medications or other medical therapy, such as blood products or electrolytes. IV lines are conventionally held to the insertion site in the patient by dressing covers that have an adhesive which bonds to the patient's skin surrounding the insertion site.

Various adhesives may be used to facilitate bonding of the dressing cover to the patient's skin. Generally, it may be desirable to minimize movement of the IV line once attached to the patient. Movement of the IV line can cause irritation of a blood vessel, disrupt proper introduction of medications to the patient, and/or increase the potential for bleeding or infection at the IV insertion site. If excessive movement occurs, the IV catheter can even come out of the patient, interrupting delivery of medication and requiring re-insertion of the catheter. Accordingly, a strong adhesion force between the dressing cover and the patient's skin may be desired to ensure secure positioning of the IV catheter during use.

Conversely, a weaker adhesion force may be desirable if removal of the dressing cover is anticipated. For example, a clinician may need periodic access to the insertion site for inspection, cleaning, to administer treatment, etc. On such occasions, the clinician will typically remove the dressing cover from the patient, perform the required task, and reattach (or replace) the dressing cover. Removal of the dressing cover can cause pain and skin injury as the adhesive is separated from the patient's skin. Accordingly, a weaker adhesion force between the dressing cover and the patient's skin may be desired to reduce patient discomfort and the risk of skin injury.

Conventional dressing covers balance the desire to securely hold the IV line to the patient with the competing desire reduce patient discomfort and risk of injury during removal of the dressing cover. An example of a dressing cover of the prior art is shown inFIG.12, which illustrates the forces applied to the patient's skin during removal of the dressing cover. Referring toFIG.12, as the dressing cover10is peeled away from the patient's skin30, a tension force, illustrated by vector Vp, is developed in the dressing cover10. The tension force may correspond to the force required to separate the adhesive of the dressing cover10from the patient's skin30. The tension force developed in the dressing cover10is transferred to the patient's skin30, illustrated by vector Vs. Substantially all of the tension force applied to the dressing cover10may be imparted to the patient's skin30(i.e. the magnitudes of vector Vp and vector Vs may be substantially equal), creating a significant risk of pain and/or skin injury during removal of the dressing cover10. Further, a stress concentration occurs at a point Pk1on the patient's skin30where the dressing cover10separates from the patient's skin30. The stress concentration further exacerbates the risk and severity of pain and/or skin injury during removal of the dressing cover10.

SUMMARY

In view of the foregoing, there exists a need for dressing covers that can securely hold an IV catheter in place without causing patient discomfort and potential skin injury during removal of the dressing cover.

In accordance with an aspect of the present disclosure, a dressing cover is disclosed. The dressing cover includes a base layer having an adhesive configured to adhere to skin of a patient, the base layer defining a cutout configured to provide access to a cannula insertion site of the skin. The dressing cover also includes a top layer having an adhesive removably adhered to the base layer, the top layer configured to cover the insertion site and including an at least partially transparent window overlaying the cutout of the base layer, the window configured to allow observation of the insertion site.

In some embodiments, the base layer extends beyond a perimeter of the top layer.

In some embodiments, the base layer includes an outwardly extending tab.

In some embodiments, the top layer includes an outwardly extending tab.

In some embodiments, the adhesive of the top layer is not present on the outwardly extending tab of the top layer.

In some embodiments, the adhesive of the top layer is weaker on the tab than on a remaining portion of the top layer.

In some embodiments, the base layer includes an outwardly extending tab, and the outwardly extending tab of the top layer overlaps the outwardly extending tab of the base layer.

In some embodiments, the top layer includes a tunnel configured to receive a treatment line therethrough.

In some embodiments, the tunnel terminates at an intermediate portion of the window.

In some embodiments, the adhesive of the top layer is not present on the tunnel.

In some embodiments, the top layer includes an outwardly extending tab extending from an opposite side of the top layer relative to the tunnel.

In some embodiments, the base layer includes an adhesive pad configured to adhere to the treatment line.

In some embodiments, the adhesive of the top layer is a static adhesive.

In some embodiments, the adhesive of the top layer is weaker than the adhesive of the base layer.

In some embodiments, the adhesive of the top layer is stronger than the adhesive of the base layer.

In accordance with another aspect of the present disclosure, a treatment line and dressing cover assembly are disclosed. The assembly includes a dressing cover including a base layer having an adhesive configured to adhere to skin of a patient, the base layer defining a cutout configured to provide access to a cannula insertion site of the skin. The dressing cover also includes a top layer having an adhesive removably adhered to the base layer, the top layer configured to cover the insertion site and including an at least partially transparent window overlaying the cutout of the base layer, the window configured to allow observation of the insertion site. The assembly also includes a treatment line secured between the base layer and the top layer, the treatment line having a cannula configured for insertion in the insertion site.

In some embodiments, the base layer extends beyond a perimeter of the top layer.

In some embodiments, the top layer includes a tunnel configured to receive the treatment line therethrough.

In some embodiments, the tunnel terminates at an intermediate portion of the window.

In some embodiments, the base layer includes an adhesive pad configured to adhere to the treatment line.

Further details and advantages of the various examples described in detail herein will become clear upon reviewing the following detailed description of the various examples in conjunction with the accompanying drawing figures.

DETAILED DESCRIPTION

Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less.

The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

As used herein with reference to a device or apparatus connected to a patient, the term “proximal” refers to an end of the device or apparatus farthest from the patient, or to a direction toward the end of the device or apparatus farthest from the patient. As used herein with reference to a device or apparatus connected to a patient, the term “distal” refers to an end of the device or apparatus closest to the patient (e.g. the end of the device or apparatus connected to the patient), or to a direction toward the end of the device or apparatus closest to the patient.

As used herein, “at least one of” is synonymous with “one or more of”. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

Non-limiting embodiments of the present disclosure are directed to a dressing cover for securing a treatment line, such as an IV treatment line, to a cannula insertion site of a patient's skin. The insertion site may correspond to a location of a vein into which a cannula or catheter of the IV treatment line is inserted to deliver fluid to the patient. Referring first toFIGS.1-4, a dressing cover100is shown securing an IV treatment line200to an insertion site310of a patient300. The dressing cover100may, in particular, be adhered to the patient's skin320surrounding the insertion site310. The dressing cover100may generally include a base layer110having an adhesive configured for adhering to the patient's skin320and a top layer130removably adhered to the base layer110. The IV treatment line200may be arranged between the base layer110and the top layer130, such that the IV treatment line200is held in place relative to the insertion site310by the dressing cover100. The top layer130covers and protects the insertion site310during administration of fluid to the patient300via the IV treatment line200. The top layer130may be removable from the base layer110to allow a clinician access to the insertion site310and the IV treatment line200without removing the base layer110from the patient's skin320.

With continued reference toFIGS.1-4and further reference toFIGS.5and6, the base layer110may include or define a cutout112providing access to the insertion site310. In particular, the base layer110may be applied to the patient's skin320such that the cutout112surrounds the insertion site310. The cutout112may be circular, elliptical, polygonal, or any other shape. The base layer110may include an adhesive pad114for receiving and holding the IV treatment line200. In some non-limiting embodiments, the adhesive pad114may be positioned so as to receive a hub222of the IV treatment line200. The hub222may be a junction where one or more lumens220of the IV treatment line200merge. The hub222may have a flat surface configured to adhere to the adhesive pad114. In some non-limiting embodiments, the one or more lumens220may be adhered to the adhesive pads114to secure the IV treatment line200in place relative to the insertion site310.

With continued reference toFIGS.1-6, the base layer110may be of substantially any shape. In the non-limiting embodiments shown in the accompanying drawings, the base layer110may be four-sided with rounded corners. The cutout112may likewise be of substantially any shape, and is desirably large enough to provide ready view of and access to the insertion site310. The base layer110may be made from a material having a higher tension strength (or higher stress vs. strain curve) than human skin, such that the base layer110mitigates forces applied to the patient's skin320during removal of the top layer130. Further details of the role of the base layer110in mitigating forces on the patient's skin are described herein with reference toFIG.11.

With continued reference toFIG.6, the base layer110may include an outwardly extending tab116. The tab116may be held against the patient's skin320by the clinician when the top layer130is removed to prevent the base layer110from inadvertently detaching from the patient's skin320. The tab116may extend from the opposite side of the base layer110as the tunnel132(and thus opposite from the IV treatment line200extending through the tunnel132) to reduce the likelihood of jostling the IV treatment line200when the tab116is being held and the top layer130is being removed.

With continued reference toFIG.6, an underside118of the base layer110may include an adhesive120configured to adhere to the patient's skin320. For clarity, only a portion of the underside118of the base layer110is shown as having the adhesive120inFIG.6. However, in non-limiting embodiments, the adhesive120may cover the entire underside118of the base layer110. In non-limiting embodiments, the adhesive120may be provided in discrete sections of the underside118of the base layer110. In non-limiting embodiments, the adhesive120may be provided in a pattern on the underside118of the base layer110. The adhesive120may be a hydrocolloid adhesive, a zinc oxide-based adhesive, and/or any other variety of adhesive suitable for contact with the patient's skin320. A topside111(shown inFIG.5) of the base layer110may be substantially free of an adhesive.

Referring now toFIGS.1-4,7, and8, the top layer130is configured to be placed over the base layer110and to provide further support for holding the IV treatment line200in place relative to the insertion site310. Further, the top layer130may cover the portion of the patient's skin320exposed through the cutout112of the base layer110, including the insertion site310and a region adjacent to the insertion site310. The top layer130may include or define a tunnel132configured to receive the IV treatment line200therethrough. The tunnel132may fit around the one or more lumens220of the IV treatment line200extending from the insertion site310. The tunnel132may include a raised profile offset from the base layer110when the top layer130is connected to the base layer110, such that a portion of the top layer130surrounding the tunnel132may sit flat against the base layer110while the IV treatment line200passes through the tunnel132. The tunnel132may serve as an alignment feature to assist the clinician in accurately applying the top layer130to the base layer110. In particular, the tunnel132may be configured to fit snugly around the IV treatment line200such that the top layer130must be applied in alignment with the base layer110in order for the IV treatment line200to be received in the tunnel132.

Referring now toFIGS.1-4and9, the top layer130may include a window150to allow the clinician to observe the insertion site310with the top layer130in place. The window150may be transparent or semi-transparent (i.e. at least partially transparent) such that the insertion site310can be viewed through the window150. The position of the window150within the top layer130may correspond to the position of the cutout112in the base layer110, such that the window150overlays the cutout112and facilitates observation of the patient's skin320exposed by the cutout112. The window150may include a tunnel152which is a continuation of the tunnel132of the top layer130. The IV treatment line200may extend through the tunnel152of the window150in the same manner that the IV treatment line200extends through the tunnel132of the top layer130. The tunnel152may terminate at an intermediate location of the window150, such as a location where a cannula210of the IV treatment line200is inserted into the insertion site310. The window150, at least in the portion thereof corresponding to the cutout112of the base layer110, lacks adhesive such that the window150does not bond to the patient's skin320exposed by the cutout112. The window150may serve as an alignment feature to assist the clinician in accurately applying the top layer130to the base layer110. In particular, the clinician may observe the cutout112of the base layer110through the window150as the top layer130is applied to the base layer110, and the clinician may place the top layer130on the base layer110such that the window150aligns with the cutout112.

Referring again toFIGS.7and8, the top layer130may include an outwardly extending tab134. In non-limiting embodiments, the tab134of the top layer130may overlap the tab116of the base layer110when the dressing cover100is assembled. In non-limiting embodiments, the tab134of the top layer130may be spaced apart from the tab116of the base layer110when the dressing cover100is assembled. A clinician may grasp the tab134to remove the top layer130from the base layer110.

Referring now particularly toFIG.8, an underside136of the top layer130may include an adhesive138configured to releasably hold the top layer130to the base layer110. For clarity, only a portion of the underside136of the top layer130is shown as having the adhesive138inFIG.8. However, in non-limiting embodiments, the adhesive138may cover the entire underside136of the top layer130, with the exception of the window150. In non-limiting embodiments, the adhesive138may be provided in discrete sections of the underside136of the top layer130. In non-limiting embodiments, the adhesive138may be provided in a pattern on the underside136of the top layer130. In non-limiting embodiments, the adhesive138may not be present in the tunnel132so that the top layer130does not adhere to the IV treatment line200. In non-limiting embodiments, the adhesive138may not be present on a portion of the underside136of the top layer130corresponding to the tab134, such that the tab134may be easily grasped. In non-limiting embodiments, the adhesive138present on the tab134may be weaker than the adhesive138on the remainder of the top layer130, such that the tab134may be induced to separate from the base layer110under less force than the remainder of the top layer130.

The adhesive138may be a hydrocolloid adhesive, a zinc oxide-based adhesive, a static adhesive, and/or any other variety of adhesive suitable for connecting the top layer130to the base layer110. In non-limiting embodiments, the adhesive138of the top layer130may be the same type of adhesive as the adhesive120of the base layer110. In non-limiting embodiments, the adhesive138of the top layer130may be a different type of adhesive as the adhesive120of the base layer110. In non-limiting embodiments, the adhesive138of the top layer130may be a weaker adhesive than the adhesive120of the base layer110to prevent base layer from being detached from the patient's skin320when the top layer130is removed.

In non-limiting embodiments, the adhesive138of the top layer130may be a stronger adhesive than the adhesive120of the base layer110, and the clinician may hold the tab116of the base layer110to prevent the base layer110from being detached from the patient's skin320when the top layer130is removed. As the base layer110may extend beyond the perimeter of the top layer130, the adhesive138of the top layer130typically does not contact the patient.

With continued reference toFIGS.7and8, the top layer130may be of substantially any shape. In the non-limiting embodiments shown in the accompanying drawings, the top layer130may be four-sided with rounded corners. In non-limiting embodiments, the top layer130may be the same shape or substantially the same shape as the base layer110. In non-limiting embodiments, the top layer130may be smaller than the base layer110such that the base layer110extends beyond the top layer130around a perimeter of the top layer130, thereby preventing the adhesive138of the top layer from contacting the patient's skin320. In non-limiting embodiments, the top layer130, with the exception of the window150, may be opaque. In non-limiting embodiments, the top layer130inclusive of the window150may be at least partially transparent. The top layer130may define a cutout131for receiving the window150during manufacturing of the top layer130.

Referring now toFIG.10, the dressing cover100is shown with the top layer130partially removed from the base layer110. The top layer130may be removed by grasping the tab134and peeling the top layer130away from the base layer110. The clinician may hold the tab116of the base layer110against the patient's skin320during removal of the top layer130to prevent the base layer110from being removed by the adhesive138of the top layer130. As the top layer130is peeled away, the topside111of the base layer110is exposed. The underside136of the top layer130is also exposed in the peeled portion of the top layer130as the top layer130is peeled away.

Referring now toFIG.11, a force diagram of the dressing cover100is shown during removal of the top layer130. As the top layer130is peeled away from the base layer110, a top layer tension force, illustrated by vector Vt inFIG.11, is developed in the top layer130in a direction in which the top layer130is peeled. The top layer tension force may correspond to the force required to separate the adhesive138of the top layer130from the base layer110. A base layer tension force, illustrated by vector Vb inFIG.11, is developed in the base layer110in a direction parallel to the patient's skin320and in an opposite direction from which the top layer130is peeled. Additionally, a stress concentration is present at a point Pk2of the base layer110where the top layer130separates from the base layer110.

Fractions of the top layer tension force and the base layer tension force are imparted to the patient's skin320, illustrated by vectors Vst and Vsb, respectively, inFIG.11. Because the base layer110remains attached to the patient's skin320during removal of the top layer130, a significant portion of the tension forces produced by removal of the top layer130are absorbed by the base layer110. As such, the magnitudes of the vectors Vst and Vsb, indicative of the force experienced by the patient's skin320, may be significantly less than the magnitudes of the vectors Vt and Vb. Similarly, the stress concentration at point Pk2may be substantially absorbed by the base layer110rather than being imparted to the patient's skin320. The more rigid the base layer110is, the lower the magnitudes of the vectors Vst and Vsb will be. Thus, a more rigid base layer110will reduce the risk of pain and/or skin injury experienced by the patient300during removal of the top layer130from the base layer110. Additionally, the adhesive138of the top layer130can be relatively strong, as the force required to overcome the strength of the adhesive138is not fully imparted to the patient's skin320. Rather, a significant portion of the force required to overcome the strength of the adhesive138is absorbed by the base layer110. In contrast, substantially all of the tension forces developed during removal of a single layer dressing cover are imparted to the patient's skin, as described herein with reference toFIG.12.