ELUID-ACTIVATED DRESSING

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/713,382, filed on August 1, 2018, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present disclosure relates generally to the field of packaging for dressings, and more particularly to packaging for fluid-activated dressings for wound therapy. Fluid- activated dressings include wound therapy dressings that require hydration with saline, Ringer’s solution, or some other fluid before application to low-exudate wounds, for example collagen dressings and oxidized regenerated cellulose (ORC) dressings. Hydration of such a dressing may activate one or more advantageous therapeutic properties of the dressing, for example by initiating a gel-forming process for the dressing.

[0003] To apply a fluid-activated dressing, a caregiver is conventionally required to open the packaging of the fluid-activated dressing, acquire a separate source of sterile fluid (e.g., saline, Ringer’s solution), and manually apply the fluid to the dressing while estimating how much fluid to apply. This workflow may be cumbersome and messy while also creating a risk of over- or under-hydrating the dressing. Further, inconsistencies between various fluids used to hydrate the dressings may lead to variations in dressing performance. Improved packaging for fluid-activated dressings may address all of these challenges.

SUMMARY

[0004] One embodiment of the present disclosure is an assembly. The assembly includes a compartment containing a sterile fluid. The assembly also includes a fluid impermeable membrane and a tray coupled to the compartment. The membrane blocks a fluid passageway between the compartment and the tray. The assembly also includes a fluid-activated dressing positioned in the tray. At least a portion of the sterile fluid is configured to move from the compartment to the tray upon user activation. [0005] In some embodiments, the user activation results in a breach of the membrane. In some embodiments, the user activation includes at least one of a squeeze of the compartment to create a pressure that breaches the membrane or an engagement of a protrusion extending into the compartment to breach the membrane.

[0006] In some embodiments, the fluid-activated dressing is a freeze-dried sponge. In some embodiments the fluid-activated dressing is comprised of collagen and oxidized regenerated cellulose.

[0007] In some embodiments, the tray is configured to receive the fluid from the compartment and contain the fluid in contact with the fluid-activated dressing. In some embodiments, the compartment is removable from the tray to provide access to the dressing. The dressing is removable from the tray.

[0008] In some embodiments, the assembly includes a protrusion extending into the compartment and configured to breach the membrane. In some embodiments, the protrusion and the lid are molded as a continuous piece.

[0009] In some embodiments, the protrusion is coupled to a button and the button is coupled to the compartment and positioned at a hole through the compartment. The protrusion extends through the hole and the button is depressible to create contact between the protrusion and the membrane. In some embodiments, one or more ridges extend from the lid past a top surface of the button.

[0010] In some embodiments, a protrusion is fixedly coupled to a tab extending from the compartment. The tab is rotatable relative to the membrane to pierce the membrane with the protrusion.

[0011] In some embodiments, the compartment is manufactured from a transparent material. In some embodiments, the fluid includes one or more of saline or sodium lactate solution.

[0012] Another implementation of the present disclosure is a method of manufacturing a dressing assembly. The method includes coupling a protrusion to a lid, adding a fluid to the lid, sealing a membrane to the lid to contain the fluid between the membrane and the lid, positioning a fluid-activated dressing in a tray, and removably coupling the tray to the lid. The protrusion is manipulable by a user to create a breach in the membrane that allows the fluid to flow therethrough to contact the fluid-activated dressing.

[0013] In some embodiments, the tray is configured to receive the fluid via the breach and contain the fluid in contact with the fluid-activated dressing. In some embodiments, removably coupling the tray to the lid includes sealing the tray to the lid to prevent the fluid from leaking between the tray and the lid.

[0014] In some embodiments, coupling the protrusion to the lid includes molding the protrusion and the lid as a continuous piece. In some embodiments, coupling the protrusion includes coupling a button to the lid. The protrusion is coupled to the button, and the button is depressible to create contact between the protrusion and the membrane.

[0015] In some embodiments, the fluid includes one or more of saline or sodium lactate solution. In some embodiments, the method also includes manufacturing the lid from a transparent material. In some embodiments, sealing the membrane to the lid comprises establishing tension in the membrane. The tension facilitates creation of the breach.

[0016] Another implementation of the present disclosure is a method of treating a wound with a fluid-activated dressing contained in a tray of a packaging assembly. The packing assembly comprising a compartment removably coupled to the tray and containing a fluid, a membrane separating the fluid from the tray, and a protrusion extending into the

compartment. The method includes manipulating the protrusion to create a hole in the dressing, waiting a duration of time to allow the fluid to enter the tray via the hole and activate the fluid-activated dressing, separating the compartment from the tray, removing the dressing from the tray, and applying the dressing to a wound site.

[0017] In some embodiments, the fluid-activated dressing includes one or more of a collagen dressing or an oxidized regenerated cellulose dressing. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is an exploded perspective view of a packaging assembly including a fluid- absorbent dressing, according to an exemplary embodiment.

[0019] FIG. 2 is a first view in a sequence of cross-sectional side views of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0020] FIG. 3 is a second view in the sequence of cross-sectional side views of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0021] FIG. 4 is a third view in the sequence of cross-sectional side views of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0022] FIG. 5 is a fourth view in the sequence of cross-sectional side views of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0023] FIG. 6 is a fifth view in the sequence of cross-sectional side views of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0024] FIG. 7 is a cross-sectional side view of a first alternative embodiment of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0025] FIG. 8 is another cross-sectional side view of the packaging assembly of FIG. 7, according to an exemplary embodiment.

[0026] FIG. 9 is a cross-sectional side view of a second alternative embodiment of the packaging assembly of FIG. 1, according to an exemplary embodiment.

[0027] FIG. 10 is another cross-sectional side view of the packaging assembly of FIG. 9, according to an exemplary embodiment.

DETAIFED DESCRIPTION

[0028] Referring generally to the FIGFTRES, a fluid-activated dressing packaged in a packaging assembly is shown, according to exemplary embodiments. The packaging assembly provides for on-demand controlled hydration of the fluid-activated dressing with fluid included in the packaging assembly. The systems and methods of the present disclosure thereby eliminate the need for a user to provide an external source of hydration fluid

(solution), ensure that an ideal or optimal amount of fluid is supplied to the dressing, ensure that the solution used is sterile, and improve the workflow for hydrating and applying fluid- activated dressings.

[0029] Referring now to FIG. 1, an exploded perspective view of a packaging assembly 100 is shown, according to an exemplary embodiment. The packaging assembly 100 is configured to provide controlled hydration of a fluid-absorbent dressing 102 (dressing 102) included with the packaging assembly 100. The packaging assembly 100 includes a tray 104 that holds the dressing 102, a lid 106 removably coupled to the tray 104, a membrane 108 coupled to the lid 106. As shown in FIG. 1, the packaging assembly 100 also includes a button 110 coupled to the lid 106. The dressing 102 is positioned between the tray 104 and the membrane 108, and the membrane 108 is positioned between the dressing 102 and the lid 106. As described in detail below, the membrane 108 and the lid 106 combine to form a compartment configured to contain a fluid.

[0030] The dressing 102 includes one or more fluid-activated dressing materials, for example collagen and/or oxidized regenerated cellulose (ORC). As one illustrative example, the dressing 102 may be a PROMOGRAN™ Matrix Wound Dressing by Acelity™. In some embodiments, the dressing 102 is a freeze-dried sponge. The dressing 102 has one or more therapeutic properties that are activated when the dressing 102 is hydrated, i.e., exposed to a fluid such as saline or Ringer’s solution. For example, a dressing 102 made of collagen and/or ORC material may enter a gel- forming process when exposed to saline or Ringer’s solution that allows the dressing 102 to provide a moist wound healing environment while lowering protease and elastase activity. A proper level of hydration (e.g., exposure to an ideal amount of fluid) may be key to maximizing the therapeutic benefits of the dressing 102.

[0031] The tray 104 has a concave (e.g., bowl-like) shape with a recessed center portion 112 surrounded by a rim 114. The rim 114 is raised from the recessed center portion 112 at a height greater than the thickness of the dressing 102, while the area of the recessed center portion 112 is greater than an area of the dressing 102. The dressing 102 may thus be received by the tray 104 such that the dressing 102 sits below the rim 114. The tray 104 is manufactured from an impermeable or substantially impermeable material. In some embodiments, the tray 104 is transparent or translucent.

[0032] The lid 106 has a concave (e.g., bowl-like) shape, with a top 116 and side walls 118 extending around the top 116. The top 116 may have substantially the same shape and size as the recessed center portion 112 of the tray 104, and the side walls 118 may align with the rim 114 of the tray 104. The lid 106 is manufactured from an impermeable or substantially impermeable material. In some embodiments, the lid 106 is transparent or translucent. In the embodiment shown in FIG. 1, the button 110 is positioned centrally on the lid 106.

[0033] The membrane 108 is a fluid-impermeable barrier sealed to the side walls 118 of the lid 106 to form a compartment configured to contain a fluid. The membrane 108 blocks a fluid passageway between the compartment and the tray 104. The membrane 108 is configured to be breached by a user to allow fluid to flow therethrough. For example, in some embodiments the membrane 108 may be breached by a pressure applied to the membrane by a user squeezing the packaging assembly 100 (e.g., a pressure forcing the fluid against the membrane). As another example, in some embodiments the membrane allows a breach (e.g., hole, slot, perforation, gap, gash, etc.) to be made therethrough by a protrusion extending between the membrane 108 and the lid 106, as described in detail below with reference to FIGS. 2-10.

[0034] Referring now to FIGS. 2-6, a sequence of cross-sectional side views of the packaging assembly 100 are shown, according to an exemplary embodiments. The sequence of FIGS. 2-6 illustrates a process for hydrating and applying the dressing 102, according to one illustrative embodiment.

[0035] As shown in FIG. 2, the packaging assembly 100 is in an initial configuration. The packaging assembly 100 may be manufactured and distributed in the initial configuration shown in FIG. 2. The packaging assembly 100 includes a compartment 200 formed by the lid 106 and the membrane 108. The membrane 108 is coupled to the lid 106 (i.e., coupled to side walls 118) and defines an inner volume that is full of a fluid 202 in the starting condition of FIG. 2. The membrane 108 is sealed to the lid 106 to substantially prevent leakage of fluid 202 between the lid 106 and the membrane 108.

[0036] The fluid 202 is a sterile solution, for example saline solution, Ringer’s solution (i.e., sodium lactate solution), or another sterile solution. In some embodiments, the fluid 202 is a specialized activation solution particularly suited for activating one or more therapeutic properties of the dressing 102. The amount of fluid 202 in the compartment 200 may be predetermined to be an ideal or optimal amount of fluid for hydrating the dressing 102. For example, a predetermined ratio of fluid volume to dressing size may be used to determine the amount of fluid 202 to be included with the packaging assembly 100.

[0037] The membrane 108 separates the fluid 202 from the tray 104 and the dressing 102 positioned in the tray 104. The tray 104 is removably sealed to the lid 106 to prevent leaks of fluid or contaminants into or out of the packaging assembly 100. In the initial configuration of the packaging assembly 100 shown in FIG. 2, the dressing 102 is isolated from the fluid 202 such that the dressing 102 remains dry. The packaging assembly 100 also protects the dressing 102 from other contaminants to preserve sterility of the dressing 102.

[0038] A button 110 is coupled to the lid 106 and positioned at a hole 204 in the lid 106.

The button 110 may be flush with the top 116 of the lid 106, may be raised above the top 116 of the lid 106, or may be recessed below the top 116 of the lid 106 (i.e., towards the membrane 108). The button 110 includes a protrusion 206 that extends between the lid 106 and the membrane 108. The protrusion 206 is configured to pierce, cut, or otherwise create a hole in the membrane 108 when manipulated by a user. For example, the protrusion 206 may be formed as a sharp point as shown in FIG. 2.

[0039] The button 110 is depressible by a user to bring the protrusion 206 into contact with the membrane 108 to create a hole in the membrane 108, as shown in FIG. 3 and described in detail with reference thereto. As shown in FIG. 2, the lid 106 includes ridges 208 that extend above the button 110 (i.e., past a top surface of the button 110). The ridges 208 thereby mitigate the risk of accidental depression of the button 110. In some embodiments, the button 110 is only depressible under a substantial force directed in a particular direction (e.g., normal to the top 116 of the lid 106), substantially reducing the risk of accidental depression of the button 110. The packaging assembly 100 is thereby configured to substantially prevent the protrusion 206 from creating a hole in the membrane 108 without deliberate manipulation from a user.

[0040] As shown in FIG. 3, the button 110 is depressed (e.g., pushed by a user), causing the protrusion 206 to create (e.g., poke, pierce, cut, pop, puncture) a hole 300 through the membrane 108. In some embodiments, the button 110 has a resilient property that causes the button 110 to spring back towards the lid 106 (i.e., towards the position of the button 110 shown in FIG. 2) to remove the protrusion 206 from the hole 300 to allow fluid 202 to flow through the hole 300. In some embodiments, the membrane 108 is configured to contract or tear such that the hole 300 becomes larger than the area of the protrusion 206 that contacted the membrane 108. In some embodiments, the protrusion 206 includes channels or perforations that allow fluid 202 to flow through the protrusion 206 and the hole 300 to reach the tray 104.

[0041] Upon user activation, the hole 300 allows the at least a portion of the fluid 202 to flow therethrough from the compartment 200 into the tray 104 where the fluid 202 contacts the dressing 102. The fluid 202 may be drawn through the hole 300 by the force of gravity. The packaging assembly 100 may include an indicator of which way to position the packaging assembly 100 to allow gravity to pull the fluid 202 from the compartment 200 into the tray 104. The tray 104 receives the fluid 202 and retains the fluid 202 in contact with the dressing 102. After a duration of time, substantially all of the fluid 202 may flow from the compartment 200 through the hole 300 to the tray 104.

[0042] As shown in FIG. 4, substantially all of the fluid 202 is retained in the tray 104 in contact with the dressing 102. According to various embodiments, the dressing 102 may be immersed in the fluid 202, may be partially covered with the fluid 202, may float in the fluid 202, etc. With the packaging assembly 100 in the condition shown in FIG. 4, the dressing 102 may soak in the fluid 202 for a duration of time before become sufficiently hydrated, i.e., before fluid-activated therapeutic properties of the dressing 102 are activated. In some embodiments, the assembly 100 includes an indicator configured to indicate to a user when the dressing 102 is sufficiently hydrated. [0043] As shown in FIG. 5, the compartment 200 (i.e., the lid 106 and the membrane 108) is detached from the tray 104. The packaging assembly 100 may include a tab, grip, etc. to facilitate detachment of the compartment 200 from the tray 104. For example, in some embodiments, the compartment 200 away from the tray 104 to unbind an adhesive that holds the compartment 200 to the tray 104. In some embodiments, the compartment 200 and the tray 104 may be threaded onto one another such that the compartment 200 can be rotated to unscrew the compartment 200 from the tray 104 to detach the compartment 200.

[0044] As shown in FIG. 6, the hydrated dressing 102 may then be removed from the tray 104 for application to a wound bed of a patient. The fluid 202 is retained by the tray 104.

The tray 104, the fluid 202, the membrane 108, the lid 106, and the button 110 may be disposed of, while the dressing 102 is applied to the wound bed.

[0045] Thus, as illustrated by FIGS. 2-6, the packaging assembly 100 provides user- friendly hydration of the dressing 102 with a controlled amount of fluid 202 provided to the dressing 102 upon user activation. Additionally, the packaging assembly 100 eliminates the need for a user to provide an external source of fluid, and gives the manufacturer of the dressing 102 control over the sterility and composition of the fluid 202. After hydration, the dressing 102 may be easily removed from the tray 104 and applied to wound bed to facilitate wound healing, and the remainder of the packaging assembly 100 may be discarded.

[0046] Referring now to FIGS 7-8, a first alternate embodiment of the packaging assembly 100 is shown, according to an exemplary embodiment. The packaging assembly 100 includes a lid 106 and membrane 108 that form a compartment 200 that contains a fluid 202 and a tray 104 that contains the dressing 102. In the embodiment of FIGS. 7-8, the protrusion 206 and the lid 106 are molded as a continuous piece, such that the protrusion 206 is an integral part of the lid 106. The protrusion 206 and the lid 106 may be made of the same material. The protrusion 206 forms a point directed normal to the top 116 of the lid 106 and pointed towards the membrane 108.

[0047] As shown in FIG. 8, the lid 106 may be flexible under a force to allow the lid 106 to flex towards the membrane 108 far enough for the protrusion 206 to contact the membrane 108 and create (e.g., poke, pierce, puncture) a hole 300 in the membrane 108. In other words, the protrusion 206 is manipulable by a user to create the hole 300 in the membrane 108. The tray 104 may also flex under a force to facilitate creation of the hole 300 by the protrusion 206. The packaging assembly 100 is thereby configured to be squeezed between the thumb and forefinger of a user to break the membrane 108 and allow the fluid 202 to come in contact with the dressing 102.

[0048] Referring now to FIGS. 9-10, a second alternative embodiment of the packaging assembly 100 is shown, according to an exemplary embodiment. The packaging assembly 100 includes a lid 106 and membrane 108 that form a compartment 200 that contains a fluid 202 and a tray 104 that contains the dressing 102. As shown in FIG. 9, the protrusion 206 extends through a side wall 118 of the lid 106 into the volume between the lid 106 and the membrane 108. In other embodiments, the protrusion 206 extends between the side wall 118 and the membrane 108. The protrusion 206 is substantially rigid and may pivot around a fulcrum 900 where the protrusion 206 intersects the side wall 118. The protrusion 206 is fixedly coupled to a tab 1000 that extends out from the compartment 200 (i.e., away from the volume containing the fluid 202). The protrusion 206 may include a hook 1002 extending from the protrusion 206 towards the membrane 108 and configured to pierce, cut, poke, or otherwise create a hole 300 in the membrane 108 when the protrusion 206 is manipulated by a user.

[0049] As illustrated by FIG. 10, the tab 1000 is rotatable or flexible relative to the membrane 108. Because the protrusion 206 is fixedly coupled to the tab 1000, a rotation of the tab 1000 causes a rotation of the protrusion 206. Thus, the tab 1000 may be rotated towards the lid 106 (i.e., clockwise from the perspective shown in FIGS. 9-10) to cause the protrusion 206 to contact the membrane 108 to pierce (e.g., cut, poke) the membrane 108 and create the hole 300 in the membrane 108 as shown in FIG. 10.

[0050] Various other embodiments of the packaging assembly 100 are contemplated by the present disclosure. For example, in some embodiments, the protrusion 206 is positioned at least partly between the tray 104 and the membrane 108, such that the protrusion 206 creates the hole 300 in the membrane 108 from the underside of the membrane 108 (i.e., from the side of the membrane 108 facing the dressing 102). In various embodiments, various numbers of protrusions 206 are included with the packaging assembly 100 to facilitate creation of multiple holes 300 through the membrane 108. It should be understood that all such variations and combinations thereof are contemplated by the present disclosure.

[0051] As utilized herein, the terms“approximately,”“about,”“substantially,” and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described and claimed without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and are considered to be within the scope of the disclosure.

[0052] Other arrangements and combinations of the elements described herein and shown in the Figures are also contemplated by the present disclosure. The construction and arrangement of the systems and apparatuses as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting

arrangements, use of materials, colors, orientations, etc.). For example, the position of elements can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. Other substitutions, modifications, changes, and omissions can be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.